NEKTAR THERAPEUTICS - Annual Report: 2009 (Form 10-K)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
DC 20549
FORM
10-K
FOR
ANNUAL AND TRANSITION REPORTS PURSUANT TO SECTIONS 13 OR 15(d)
OF
THE SECURITIES EXCHANGE ACT OF 1934
R
|
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934.
|
For
the fiscal year ended December 31, 2009
|
|
or
|
|
¨
|
TRANSITION
REPORTS PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934.
|
For
the transition period from ________ to __________
Commission
File Number: 0-24006
NEKTAR
THERAPEUTICS
(Exact
name of registrant as specified in its charter)
Delaware
|
94-3134940
|
(State
or other jurisdiction of
|
(IRS
Employer
|
incorporation
or organization)
|
Identification
No.)
|
201
Industrial Road
San
Carlos, California 94070
(Address
of principal executive offices and zip code)
650-631-3100
(Registrant’s
telephone number, including area code)
Securities
registered pursuant to Section 12(b) of the Act:
Title of Each Class
|
Name of Each Exchange on Which
Registered
|
|
Common
Stock, $0.0001 par value
|
|
NASDAQ
Global Select Market
|
Securities
registered pursuant to Section 12(g) of the Act: None
Indicate
by check mark if the registrant is a well-known seasoned issuer, as defined in
Rule 405 of the Securities Act. Yes ¨ No
R
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Act. Yes ¨ No
R
Indicate
by check mark whether the registrant (1) has filed all reports required to be
filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the
preceding 12 months (or for such shorter period that the registrant was required
to file such reports), and (2) has been subject to such filing requirements for
the past 90 days) Yes R No ¨
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§ 232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such files). Yes R No ¨
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K (§ 229.405) is not contained herein, and will not be contained,
to the best of registrant’s knowledge, in definitive proxy or information
statements incorporated by reference in Part III of this Form 10-K or any
amendment to this Form 10-K. R
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, a non-accelerated filer, or a smaller reporting company. See
the definitions of “large accelerated filer,” “accelerated filer,” and “smaller
reporting company” in Rule 12b-2 of the Exchange Act. (Check one):
Large
accelerated filer ¨
|
Accelerated
filer R
|
Non-accelerated
filer ¨
|
Smaller
reporting company ¨
|
(Do
not check if a smaller reporting
company)
|
Indicate
by check mark whether the registrant is a shell company (as defined in Exchange
Act Rule 12b-2) Yes ¨ No
R
The
approximate aggregate market value of voting stock held by non-affiliates of the
registrant, based upon the last sale price of the registrant’s common stock on
the last business day of the registrant’s most recently completed second fiscal
quarter, June 30, 2009 (based upon the closing sale price of the
registrant’s common stock listed as reported on the NASDAQ Global Select
Market), was approximately $597,697,691. This calculation excludes approximately
323,230 shares held by directors and executive officers of the registrant.
Exclusion of these shares does not constitute a determination that each such
person is an affiliate of the registrant.
As of
February 26, 2010, the number of outstanding shares of the registrant’s common
stock was 93,645,805.
DOCUMENTS
INCORPORATED BY REFERENCE
Portions
of registrant’s definitive Proxy Statement to be filed for its 2010 Annual
Meeting of Stockholders are incorporated by reference into Part III hereof. Such
Proxy Statement will be filed with the Securities and Exchange Commission within
120 days of the end of the fiscal year covered by this Annual Report on Form
10-K.
NEKTAR
THERAPEUTICS
2009
ANNUAL REPORT ON FORM 10-K
TABLE
OF CONTENTS
Page
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PART
I
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4
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Item
1. Business
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4
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Item
1A. Risk Factors
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24
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Item
1B. Unresolved Staff Comments
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35
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Item
2. Properties
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35
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Item
3. Legal Proceedings
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36
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Item
4. Submission of Matters to a Vote of Security Holders
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36
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PART
II
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37
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Item
5. Market for Registrant’s Common Equity Related Stockholder Matters and
Issuer Purchases of Equity Securities
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37
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Item
6. Selected Financial Data
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39
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Item
7. Management’s Discussion and Analysis of Financial Condition and Results
of Operations
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40
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Item
7A. Quantitative and Qualitative Disclosures About Market
Risk
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51
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Item
8. Financial Statements and Supplementary Data
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52
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Item
9. Changes in and Disagreements With Accountants on Accounting and
Financial Disclosure
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84
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Item
9A. Controls and Procedures
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84
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Item
9B. Other Information
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85
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PART
III
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86
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Item
10. Directors, Executive Officers and Corporate Governance
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86
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Item
11. Executive Compensation
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86
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Item
12. Security Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters
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86
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Item
13. Certain Relationships and Related Transactions and Director
Independence
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86
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Item
14. Principal Accounting Fees and Services
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86
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PART
IV
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87
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Item
15. Exhibits, Financial Statement Schedules
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87
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Signatures
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92
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2
Forward-Looking
Statements
This
report includes “forward-looking statements” within the meaning of Section 27A
of the Securities Act of 1933, as amended (the “Securities Act”), and Section
21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). All
statements other than statements of historical fact are “forward-looking
statements” for purposes of this annual report on Form 10-K, including any
projections of earnings, revenue or other financial items, any statements of the
plans and objectives of management for future operations (including, but not
limited to, pre-clinical development, clinical trials and manufacturing), any
statements concerning proposed drug candidates or other new products or
services, any statements regarding future economic conditions or performance,
any statements regarding expected benefits from the closing of the sale of
pulmonary assets to Novartis on December 31, 2008, any statements regarded the
timing of the move of our corporate headquarters to, and the estimated costs of,
the facility subject to the sublease with Pfizer, Inc. dated September 30, 2009,
any statements regarding the success of our collaborations including in relation
to the license agreement with AstraZeneca AB dated September 20, 2009, and
though not a 2009 agreement, any statement regarding our plans and objective for
our collaboration with Bayer Healthcare LLC entered into in August 2007 for
BAY41-6551 (NKTR-061 or Amikacin Inhale), and plans
and objectives to initiate Phase 3 clinical trials, any statements regarding the
plans and timing for a potential collaboration transaction for NKTR-102,
and any
statements of assumptions underlying any of the foregoing. In some cases,
forward-looking statements can be identified by the use of terminology such as
“may,” “will,” “expects,” “plans,” “anticipates,” “estimates,” “potential” or
“continue,” or the negative thereof or other comparable terminology. Although we
believe that the expectations reflected in the forward-looking statements
contained herein are reasonable, such expectations or any of the forward-looking
statements may prove to be incorrect and actual results could differ materially
from those projected or assumed in the forward-looking statements. Our future
financial condition and results of operations, as well as any forward-looking
statements, are subject to inherent risks and uncertainties, including, but not
limited to, the risk factors set forth in Part I, Item 1A “Risk Factors” below
and for the reasons described elsewhere in this annual report on Form 10-K. All
forward-looking statements and reasons why results may differ included in this
report are made as of the date hereof and we do not intend to update any
forward-looking statements except as required by law or applicable regulations.
Except where the context otherwise requires, in this annual report on Form 10-K,
the “Company,” “Nektar,” “we,” “us,” and “our” refer to Nektar Therapeutics, a
Delaware corporation, and, where appropriate, its subsidiaries.
Trademarks
The
Nektar brand and product names, including but not limited to Nektar®,
contained in this document are trademarks, registered trademarks or service
marks of Nektar Therapeutics in the United States (U.S.) and certain other
countries. This document also contains references to trademarks and service
marks of other companies that are the property of their respective
owners.
3
PART
I
Item
1. Business
We are a
clinical-stage biopharmaceutical company developing a pipeline of drug
candidates that utilize our PEGylation and advanced polymer conjugate technology
platforms, which are designed to improve the benefits of drugs for patients. Our
current proprietary product pipeline is comprised of drug candidates across a
number of therapeutic areas including oncology, pain, anti-infectives,
anti-viral and immunology. Our research and development activities involve small
molecule drugs, peptides and other potential biologic drug candidates. We create
our innovative drug candidates by using our proprietary chemistry platform to
modify the chemical structure of drugs by applying our proprietary advanced
polymer conjugate technologies and expertise. Polymer chemistry is a science
focused on the synthesis or bonding of polymer architectures with drug molecules
to alter the properties of the molecule when it is bonded
with polymers. Additionally, we may utilize established pharmacologic
targets to engineer a new drug candidate relying on a combination of the known
properties of these targets and our proprietary polymer chemistry technology and
expertise. Our drug candidates are designed to improve the pharmacokinetics,
pharmacodynamics, half-life, bioavailability, metabolism or distribution of
drugs and improve the overall benefits and use of a drug for the patient. Our
objective is to apply our advanced polymer conjugate technology platform to
create new drugs in multiple therapeutic areas.
Each of
our drug candidates which we are currently developing internally is a
proprietary new chemical or biological entity that addresses large potential
markets. We are developing drug candidates that can be delivered by either oral
or subcutaneous administration. Our most advanced proprietary product candidate,
Oral NKTR-118, is a peripheral opioid antagonist that is currently being
evaluated for the treatment of opioid-induced constipation. On
September 20, 2009, we entered into a license agreement with AstraZeneca AB for
the global development and commercialization of Oral NKTR-118 and NKTR-119.
NKTR-119 is an early stage research development program that combines various
opioids with Oral NKTR-118. Under this agreement, AstraZeneca assumed
all responsibility for development and commercialization of NKTR-118 and
NKTR-119. Our other lead product candidate, NKTR-102, a topoisomerase
I inhibitor-polymer conjugate, is currently being evaluated in three separate
Phase 2 clinical trials for ovarian, breast and colorectal
cancers. In addition, in 2009 we commenced a Phase 1 clinical trial
for NKTR-105 (PEGylated docetaxel) for patients with refractory solid
tumors. We also have a number of early stage programs in research and
preclinical development.
In
addition to our proprietary product candidate pipeline, we have a number of
collaborations and license, manufacturing and supply agreements for our
technology with leading biotechnology and pharmaceutical companies, including
Affymax, Amgen Baxter, Roche, Merck (formerly Schering Plough), Pfizer and UCB
Pharma. A total of seven products using our PEGylation technology platform have
received regulatory approval in the U.S. or Europe, and are currently marketed
by our partners. There are also a number of other products in clinical
development that use our technology platform. We currently anticipate that these
collaborations, and the amortization of the $125.0 million upfront payment from
AstraZeneca, will represent the majority of our revenue in 2010. We
anticipate that our 2010 revenue will be comprised of a combination of upfront
payments, contract research fees, milestone payments, manufacturing product
sales and product royalties.
We also
have a collaboration with Bayer Healthcare LLC to develop BAY41-6551 (NKTR-061,
Amikacin Inhale), which is an inhaled solution of amikacin, an aminoglycoside
antibiotic. We originally developed the liquid aerosol inhalation platform and
product and entered into a collaboration agreement with Bayer Healthcare LLC in
August 2007 for its further development and commercialization. BAY41-6551
completed Phase 2 development and we and Bayer are currently preparing for the
start of a Phase 3 clinical study. Bayer and Nektar have been working
together to prepare for the pivotal studies of BAY41-6551 following the
consummation of the collaboration in August 2007. The program is
behind schedule. The reason for this is that Bayer and Nektar decided
to finalize the design of the device for commercial manufacturing prior to
initiating Phase 3 clinical development with the objective of commencing Phase 3
clinical trials as soon as possible following completion of this
work.
On
December 31, 2008, we completed the sale and transfer of certain pulmonary
technology rights, certain pulmonary collaboration agreements and approximately
140 of our dedicated pulmonary personnel and operations to Novartis Pharma AG.
We retained all of our rights to BAY41-6551 and certain rights to receive
royalties on net sales of the Cipro Inhale (also known as Ciprofloxacin Inhaled
Powder or CIP) program with Bayer Schering Pharma AG that we transferred to
Novartis as part of the transaction. We also retained certain
intellectual property rights to patents specific to inhaled
insulin.
We were
incorporated in California in 1990 and reincorporated in Delaware in 1998. We
maintain our executive offices at 201 Industrial Road, San Carlos, California
94070, and our main telephone number is (650) 631-3100.
4
Our
Technology Platform
With our
expertise as a leader in the PEGylation field, we have advanced our technology
platform to include first-generation PEGylation and new advanced polymer
conjugate chemistries that can be tailored in very specific and customized ways
with the objective of optimizing and significantly improving the profile of a
wide range of molecules and many classes of drugs and disease
areas. PEGylation has been a highly effective technology platform for
the development of therapeutics with significant commercial success, such as
Roche’s PEGASYS®
(PEG-interferon alfa-2a) and Amgen’s Neulasta®
(pegfilgrastim). All of the PEGylated drugs approved over the last fourteen
years were enabled with our PEGylation technology through our collaborations and
licensing partnerships with a number of pharmaceutical companies. PEG
(polyethylene glycol) is a versatile technology and is a water soluble,
amphiphilic, non-toxic, non-immunogenic compound that is safely cleared from the
body. Its primary use to date has been in currently approved biologic drugs to
favorably alter their pharmacokinetic or pharmacodynamic properties. However, in
spite of its widespread success in commercial drugs, there are limitations with
the first-generation PEGylation approaches used with biologics. These
limitations include the inability of the earlier approaches of PEGylation
technology to be used successfully with small molecule drugs, antibody fragments
and peptides, all of which could potentially benefit from the application of the
technology. Other limitations of the early approaches of PEGylation technology
include resulting sub-optimal bioavailability and bioactivity, and its limited
ability to be used to fine-tune properties of the drug, as well as its inability
to be used to create oral drugs.
With our
expertise and proprietary technology in PEGylation, we have created a
next-generation of PEGylation technology. Our advanced polymer conjugate
technology platform is designed to overcome the limitations of the first
generation of the technology platform and allow the platform to be utilized with
a broader range of molecules across many therapeutic areas.
Both our
PEGylation and advanced polymer conjugate technology platforms have the
potential to offer one or more of the following benefits:
|
•
|
improve
efficacy or safety in certain instances as a result of better
pharmacokinetics, pharmacodynamics, longer half-life and sustained
exposure of the drug;
|
|
•
|
improve
targeting or binding affinity of a drug to its target receptors with the
potential to improve efficacy and reduce toxicity or drug
resistance;
|
|
•
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improve
solubility of a drug;
|
|
•
|
enable
oral administration of parenterally-administered drugs, or drugs that must
be administered intravenously or subcutaneously, and increase oral
bioavailability of small molecules;
|
|
•
|
prevent
drugs from crossing the blood-brain barrier and limiting undesirable
central nervous system effects;
|
|
•
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reduce
first-pass metabolism effects of certain drug classes with the potential
to improve efficacy, which could reduce the need for other medicines and
reduce toxicity;
|
|
•
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reduce
rate of drug absorption and of elimination or metabolism by improving
stability of the drug in the body and providing it with more time to act
on its target; and
|
|
•
|
reduce
immune response to certain macromolecules with the potential to prolong
their effectiveness with repeated
doses.
|
We have a
broad range of approaches that we may use when designing our own drug
candidates, some of which are outlined below:
Small
Molecule Stable Polymer Conjugates
Our
customized approaches for small molecule polymer conjugates allows for the
fine-tuning of the physicochemical and pharmacological properties of small
molecule oral drugs to potentially increase their therapeutic benefit. In
addition, this approach can enable oral administration of subcutaneously or
intravenously delivered small molecule drugs that may have shown low
bioavailability when delivered orally. The benefits of this approach
can also include: improved potency, increased oral bioavailability, modified
biodistribution with enhanced pharmacodynamics, and reduced transport across
specific membrane barriers in the body, such as the blood-brain barrier. A
primary example of the application of membrane transport inhibition,
specifically reducing transport across the blood-brain barrier is Oral NKTR-118,
a novel peripheral opioid antagonist that completed Phase 2 clinical development
in 2009. An example of a drug candidate that uses this approach
to avoid first-pass metabolism is NKTR-140, a protease inhibitor in the early
stages of discovery research.
5
Small
Molecule Pro-Drug Releasable Polymer Conjugates
The
pro-drug polymer conjugation approach can be used to optimize the
pharmacokinetics and pharmacodynamics of a small molecule drug to substantially
increase both its efficacy and side effect profile. We are currently using this
platform with oncolytics, which typically have sub-optimal half-lives that can
limit their therapeutic efficacy. With our technology platform, we believe that
these drugs can be modulated for programmed release within the body, optimized
bioactivity and increased sustained exposure of active drug to tumor cells in
the body. We are using this approach with the two oncolytic candidates in our
pipeline, NKTR-102, a topoisomerase I inhibitor-polymer conjugate currently in
Phase 2 clinical development, and NKTR-105, a polymer conjugate form of
docetaxel that is currently in Phase 1 clinical development.
Large
Molecule Polymer Conjugates (Proteins and Peptides)
Our
customized approaches with large molecule polymer conjugates have enabled
numerous successful PEGylated biologics on the market today. We are using our
advanced polymer conjugation technology-based approach to enable peptides, which
are much smaller in size than other biologics, such as proteins and antibody
fragments. We are in the early stages of discovery research with a number of
peptides that utilize this proprietary approach. Peptides are important in
modulating many physiological processes in the body. Some of the benefits of
working with peptides are: they are small, more easily optimized, and can be
rapidly investigated for therapeutic potential. However, peptide drug discovery
has been slowed by the extremely short half-life and limited bioavailability of
these molecules.
Based on
our knowledge of the technology and biologics, our scientists have designed a
novel hydrolyzable linker that can be used to optimize the bioactivity of a
peptide. Through rational drug design and the use of our approach, a peptide’s
pharmacokinetics and pharmacodynamics can be substantially improved and its
half-life can be significantly extended. The approach can also be used with
proteins and larger molecules, as well.
Antibody
Fragment Polymer Conjugates
This
approach uses a large molecular weight polyethylene glycol (PEG) conjugated to
antibody fragments in order to potentially improve their toxicity profile,
extend their half-life and allow for ease of synthesis with the antibody. The
specially designed PEG then becomes part of the antibody fragment Fc. Since the
antibody fragment is more like a biologic, this conjugation has a branched
architecture with either stable or degradable linkage. This approach can be used
to reduce antigenicity, reduce glomerular filtration rate, enhance uptake by
inflamed tissues, and retain antigen-binding affinity and recognition. There is
currently one approved product on the market that utilizes our technology with
an antibody fragment, CIMZIA™ (certoluzimab pegol), which was developed by our
partner UCB Pharma and is approved for the treatment of Crohn’s Disease in the
U.S. and Rheumatoid Arthritis in the U.S. and Europe.
Our
Strategy
The key
elements of our business strategy are described below:
Advance Our Internal Clinical
Pipeline of Drug Candidates that Leverage Our PEGylation and Advanced Polymer
Conjugate Chemistry Platform
Our
objective is to create value by advancing our lead drug candidates through early
to mid-stage clinical development. To support this strategy, over the past two
years we have significantly expanded and added expertise to our internal
clinical development and regulatory departments. We decide on a
product-by-product basis whether to continue development into Phase 3 pivotal
clinical trials and commercialize products on our own, or seek a partner, or
pursue a combination of these approaches. To date, we have partnered
our proprietary drug development programs prior to Phase 3 clinical
development.
A key
component of our development strategy is to potentially reduce the risks and
time associated with drug development by capitalizing on the known safety and
efficacy of approved drugs as well as established pharmacologic targets and
drugs directed to those targets. For many of our novel drug candidates, we may
seek approval in indications for which the parent drugs have not been studied or
approved. We believe that the improved characteristics of our drug candidates
will provide meaningful benefit to patients compared to the existing therapies,
and allow for approval to provide new treatments for patients for which the
parent drugs are not currently approved.
6
Ensure Future Growth of our Pipeline
through Internal Research Efforts and Advancement of our Preclinical Drug
Candidates into Clinical Trials
We
believe it is important to maintain a diverse pipeline of new drug candidates to
continue to build on the value of our business. Our discovery research
organization is identifying new drug candidates by applying our technology
platform to a wide range of molecule classes, including small molecules and
large proteins, peptides and antibodies, across multiple therapeutic areas. We
continue to advance our most promising early research drug candidates into
preclinical development with the objective to advance these early stage research
programs to human clinical studies over the next several years.
Enter into Strategic and High-Value
Partnerships to Bring Our Drugs to Market
Our
partnering strategy is to enter into collaborations with larger pharmaceutical
and biotechnology companies at appropriate stages in our drug candidate
development process to fund further clinical development, manage the global
regulatory filing process, and market and sell drugs when and if they are
approved. The options for future collaboration arrangements range
from comprehensive licensing arrangements to co-promotion and co-development
agreements with the structure of the collaboration depending on factors such as
the cost and complexity of development, marketing and commercialization needs
and therapeutic area.
Continue to Build a Leading
Intellectual Property Estate in the Field of PEGylation and Polymer Conjugate
Chemistry across Therapeutic Modalities
We are
committed to continuing to build on our intellectual property position in the
field of PEGylation and polymer conjugate chemistry. To that end, we have a
comprehensive patent strategy with the objective of developing a patent estate
covering a wide range of novel inventions including among others, polymer
materials, conjugates, formulations, synthesis, therapeutic areas and methods of
treatment.
Nektar
Proprietary Internal Drug Candidates in Clinical Development
The
following table summarizes our proprietary product candidate pipeline and
Nektar-discovered drug candidates that are being developed in partnerships with
pharmaceutical companies. The table includes the type of molecule or drug, the
target indications for the product or product candidate, and the clinical trial
status of the program.
Drug Candidate/Program
|
Target Indications
|
Status (1)
|
||
Oral
NKTR-118 (oral PEG-naloxol)
|
Opioid-induced
constipation
|
Phase
2 (Partnered with AstraZeneca AB)
|
||
BAY41-6551
(NKTR-061, Amikacin Inhale)
|
Gram-negative
pneumonias
|
Phase
2 (Partnered with Bayer Healthcare LLC)*
|
||
NKTR-102
(topoisomerase I inhibitor-polymer conjugate)
|
Second-line
colorectal cancer in patients with the KRAS gene mutation
|
Phase
2
|
||
NKTR-102
|
Metastatic
breast cancer
|
Phase
2
|
||
NKTR-102
|
Platinum-resistant/refractory
ovarian cancer
|
Phase
2
|
||
NKTR-105
(PEGylated docetaxel)
|
Solid
tumors
|
Phase
1
|
||
NKTR-119
(Opioid/NKTR-118 combinations)
|
Pain
|
Research/Preclinical
(Partnered
with
|
||
AstraZeneca
AB)
|
||||
NKTR-181
(abuse deterrent, tamper-resistant opioid)
|
Pain
|
Research/Preclinical
|
||
NKTR-194
(non-scheduled opioid)
|
Mild
to moderate pain
|
Research/Preclinical
|
||
NKTR-171
(tricyclic antidepressant)
|
Neuropathic
pain
|
Research/Preclinical
|
||
NKTR-140
(protease inhibitor candidate)
|
|
HIV
|
|
Research/Preclinical
|
(1)
|
Status
definitions are:
|
Phase 3 or Pivotal—product in
large-scale clinical trials conducted to obtain regulatory approval to market
and sell the drug (these trials are typically initiated following encouraging
Phase 2 trial results).
Phase 2—product in clinical
trials to establish dosing and efficacy in patients.
7
Phase 1—product in clinical
trials, typically in healthy subjects, to test safety. In the case of oncology
drug candidates, Phase 1 clinical trials are typically conducted in cancer
patients.
Research/preclinical—product
is being studied in research by way of vitro studies and/or animal
studies
*
|
This
product candidate uses a liquid aerosol technology platform that was
transferred to Novartis in the pulmonary asset sale transaction that was
completed on December 31, 2008. As part of that transaction, we retained
an exclusive license to this technology for the development and
commercialization of this drug candidate originally developed by
us.
|
Approved Drugs and Drug Candidates
Enabled By Our Technology through Licensing Collaborations
The
following table outlines our collaborations with a number of pharmaceutical
companies that license our technology, including Amgen, Merck (formerly
Schering-Plough), Baxter, UCB Pharma and F. Hoffmann-La Roche. A total of seven
products using our PEGylation technology have received regulatory approval in
the U.S. or Europe. There are also a number of other candidates that have been
filed for approval or are in various stages of clinical development. These
collaborations generally contain one or more elements including license rights
to our proprietary technology, manufacturing and supply agreements under which
we may receive manufacturing revenue, milestone payments, and/or product
royalties on commercial sales.
Drug
|
Primary
or Target
Indications
|
Licensing
Partner
and Drug Marketer
|
Status(1)
|
|||
Neulasta®
(pegfilgrastim)
|
Neutropenia
|
Amgen
Inc.
|
Approved
|
|||
PEGASYS®
(peginterferon alfa-2a)
|
Hepatitis-C
|
F.
Hoffmann-La Roche Ltd
|
Approved
|
|||
Somavert®
(pegvisomant)
|
Acromegaly
|
Pfizer
Inc.
|
Approved
|
|||
PEG-INTRON®
(peginterferon alfa-2b)
|
Hepatitis-C
|
Merck
(formerly Schering-Plough Corporation)
|
Approved
|
|||
Macugen®
(pegaptanib sodium injection)
|
Age-related
macular degeneration
|
Eyetech
Inc.
|
Approved
|
|||
CIMZIA™
(certolizumab pegol)
|
Crohn’s
disease
|
UCB
Pharma
|
Approved
in U.S. and Switzerland
|
|||
MIRCERA®
(C.E.R.A.) (Continuous Erythropoietin Receptor Activator)
|
Anemia
associated with chronic kidney disease in patients on dialysis and
patients not on dialysis
|
F.
Hoffmann-La Roche Ltd
|
Approved
in U.S. and EU (Launched only in the EU)*
|
|||
CIMZIA™
(certolizumab pegol)
|
Rheumatoid
arthritis
|
UCB
Pharma
|
Approved
in U.S. and EU
|
|||
Hematide™
(synthetic peptide-based, erythropoiesis- stimulating
agent)
|
Anemia
|
Affymax,
Inc.
|
Phase
3
|
|||
Levadex™
|
Migraine
|
MAP
Pharmaceuticals
|
Phase
3
|
|||
Cipro
Inhale
|
Cystic
fibrosis lung infections
|
Bayer
Schering Pharma AG
|
Phase
2**
|
|||
CIMZIA
™ (certoluzimab pegol)
|
Psoriasis
|
UCB
Pharma
|
Phase
2
|
|||
Longer-acting
Factor VIII and other blood clotting proteins
|
|
Hemophilia
|
|
Baxter
|
|
Research/preclinical
|
8
(1) Status
definitions are:
Approved—regulatory approval
to market and sell product obtained in the U.S., EU and other
countries.
Filed —Products for which a New Drug
Application (NDA) or Biologics License Application (BLA) has been
filed
Phase 3 or Pivotal—product in
large-scale clinical trials conducted to obtain regulatory approval to market
and sell the drug (these trials are typically initiated following encouraging
Phase 2 trial results).
Phase 2—product in clinical
trials to establish dosing and efficacy in patients.
Phase 1—product in clinical
trials, typically in healthy subjects, to test safety. In the case of oncology
drug candidates, Phase 1 clinical trials are typically conducted in cancer
patients.
Research/preclinical—product
is being studied in research by way of vitro studies and/or animal
studies
*
|
Amgen
Inc. prevailed in a patent lawsuit against F. Hoffmann-La Roche Ltd and as
a result of this legal ruling Roche is currently prevented from marketing
MIRCERA® in
the U.S until July 2014.
|
**
|
This
product candidate was developed using our proprietary pulmonary delivery
technology that was transferred to Novartis in an asset sale transaction
that closed on December 31, 2008. As part of the transaction, Novartis
assumed our rights and obligations for our Cipro Inhale agreements with
Bayer Schering PharmaAG; however, we maintained the rights to receive
certain royalties on commercial sales of Cipro Inhale if the product
candidate is approved.
|
With
respect to all of our collaboration and license agreements with third parties,
please refer to Item 1A, Risk Factors, including without limitation, “We are a
party to numerous collaboration agreements and other significant agreements
which contain complex commercial terms that could result in disputes, litigation
or indemnification liability that could adversely affect our business, results
of operations and financial condition.”
Overview
of Selected Proprietary Nektar Drug Development Programs and Significant
Partnered Drug Development Programs
Oral
NKTR-118 and NKTR-119, License Agreement with AstraZeneca AB
On
September 20, 2009, we entered into a license agreement with AstraZeneca AB, in
which we granted AstraZeneca a worldwide, exclusive, perpetual, royalty-bearing
license under our patents and other intellectual property to develop, market and
sell Oral NKTR-118 and NKTR-119. Under the terms of this agreement,
AstraZeneca will bear all costs associated with research, development and
commercialization for Oral NKTR-118 and NKTR-119 and will be responsible for all
development and commercialization activities. AstraZeneca made an
upfront payment to us of $125.0 million in the fourth quarter of
2009. We are also entitled to development milestone payments if
certain development and regulatory objectives are achieved and sales milestone
payments if annual sales targets are achieved, as well as royalties based on
annual worldwide net sales of Oral NKTR-118 and NKTR-119
products. AstraZeneca will use commercially reasonable efforts to
develop one product based on NKTR-119 and has the right to develop multiple
products based on NKTR-119.
Oral
NKTR-118, which combines our stable polymer conjugate technology with naloxol, a
derivative of the opioid-antagonist drug naloxone, completed Phase 2 development
in 2009. Results from the Phase 2 clinical study were presented in
October 2009 at an oral plenary session of the American College of
Gastroenterology 2009 Annual Clinical Meeting. The data presented
from the Phase 2 study showed that Oral NKTR-118 achieved the primary endpoint
of change from baseline in spontaneous bowel movements in patients taking
opiates. The study also showed there was no apparent reversal of
opioid-mediated analgesia with any of the Oral NKTR-118 dose groups, as measured
by no change in Numeric Rating Scale (NRS) pain scores and no increase in mean
daily opiate use. The most commonly reported side effects from this
Phase 2 clinical study of Oral NKTR-118 were dose dependent
gastrointestinal-related effects.
NKTR-119
is an early stage drug development program that is intended to combine Oral
NKTR-118 with selected opioids, with the goal of treating pain without the side
effect of constipation traditionally associated with opioid therapy. AstraZeneca
is responsible for all further research and development activities for
NKTR-119.
9
According
to the American Pain Society, over 200 million opioid prescriptions are filled
in the U.S. annually with worldwide sales of opioids reaching $7.5 billion in
2007. Depending on the population studied and the definitions used, constipation
occurs in up to 90% of patients taking opioids. Currently, there are no specific
oral drugs approved or specifically indicated to treat opioid induced
constipation or opioid bowel dysfunction.
BAY41-6551
(NKTR-061, Amikacin Inhale), Agreement with Bayer Healthcare LLC
In August
2007, we entered into a co-development, license and co-promotion agreement with
Bayer Healthcare LLC (Bayer) to develop a specially-formulated Amikacin
(BAY41-6551, NKTR-061, Amikacin Inhale). Under the terms of the agreement, Bayer
is responsible for most future clinical development and commercialization costs,
all activities to support worldwide regulatory filings, approvals and related
activities, further development of formulated Amikacin and final product
packaging for BAY41-6551. We are responsible for all future development of the
nebulizer device used in BAY41-6551through the completion of Phase 3 clinical
trials and for clinical and commercial manufacturing and supply of the nebulizer
device. We have engaged third party contract manufacturers to perform
our device manufacturing obligations for this program. Under the
terms of the agreement, we are entitled to development and sales milestone
payments upon achievement of certain annual sales targets. We are also entitled
to royalties based on annual worldwide net sales of BAY41-6551. Our right to
receive these royalties in any particular country will expire upon the later of
ten years after the first commercial sale of the product in that country or the
expiration of certain patent rights in that particular country, subject to
certain exceptions. The agreement expires in relation to a particular country
upon the expiration of all royalty and payment obligations between the parties
related to such country. Subject to termination fee payment obligations, Bayer
also has the right to terminate the agreement for convenience. In addition, the
agreement may also be terminated by either party for certain product safety
concerns, the product’s failure to meet certain minimum commercial profile
requirements or uncured material breaches by the other party. For certain Bayer
terminations, we may have reimbursement obligations to Bayer.
BAY41-6551
is in clinical development to treat Gram-negative pneumonias, including
Hospital-Acquired (HAP), Healthcare-Associated, and Ventilator-Associated
pneumonias. Gram-negative pneumonias are often the result of complications of
other patient conditions or surgeries. Gram-negative pneumonia carries a
mortality risk that can exceed 50% in mechanically-ventilated patients and
accounts for a substantial proportion of the pneumonias in intensive care units
today. BAY41-6551 is designed to be an adjunctive therapy to the
current antibiotic therapies administered intravenously as standard of care. The
targeted aerosol delivery platform in BAY41-6551 delivers the antimicrobial
agent directly to the site of infection in the lungs. This product candidate can
be integrated with conventional mechanical ventilators or used as a hand-held
‘off-vent’ device for patients no longer requiring breathing
assistance. This product candidate has completed Phase 2
clinical development.
Bayer and
Nektar have been working together to prepare for the pivotal studies of
BAY41-6551 following the consummation of the collaboration in August
2007. The program is behind schedule. The reason for this
is that Bayer and Nektar decided to finalize the design of the device for
commercial manufacturing prior to initiating Phase 3 clinical development with
the objective of commencing Phase 3 clinical trials as soon as possible
following completion of this work. Please refer to Item 1A, Risk
Factors, “If we or our partners are not able to manufacture drugs in quantities
and at costs that are commercially feasible, our proprietary and partnered
product candidates may experience clinical delays or constrained commercial
supply which could significantly harm our business.”
NKTR-102 (Topoisomerase I
inhibitor-polymer conjugate)
We are
developing NKTR-102, a novel topoisomerase I inhibitor-polymer conjugate that
was designed using our advanced polymer conjugate technology platform. This
product candidate is currently in Phase 2 clinical development in multiple
cancer indications including breast, colorectal and ovarian. By applying our
proprietary pro-drug polymer conjugate technology to irinotecan, NKTR-102 has
the potential to be a more effective and tolerable anti-tumor
agent. Irinotecan, also known as Camptosar®, is a
topoisomerase I inhibitor used for the treatment of solid tumors. Using a
proprietary approach that directly conjugates the drug to a multi-arm polymer
architecture, NKTR-102 has a unique pharmacokinetic and pharmacodynamic profile
that has demonstrated anti-tumor activity in patients in early stage clinical
trials.
Two
separate NKTR-102 Phase 2 studies are ongoing in platinum-resistant ovarian and
metastatic breast cancers. These studies are open label, single arm two-stage
studies including two treatment regimens (every 14 days or every 21 days).
Patients include those with metastatic breast cancer with prior taxane treatment
and those with metastatic and platinum-resistant ovarian cancer. These clinical
studies are designed to evaluate the overall response rate (ORR) of NKTR-102
monotherapy in each tumor setting, with certain secondary endpoints including
progression-free survival. In
January 2010, we announced preliminary results from the first stage of the
two-stage efficacy and safety trial of single-agent NKTR-102 in women with
platinum-resistant ovarian cancer. We expect to announce final
results from these Phase 2 clinical development programs in 2010.
10
Ovarian
and breast cancers are significant health problems for women worldwide. In 2008,
there were an estimated 21,650 new diagnoses and an estimated 15,520 deaths from
ovarian cancer in the United States and, historically, less than 40% of women
with ovarian cancer are cured. The American Cancer Society estimated that over
184,000 new cases of invasive breast cancer were diagnosed and nearly 41,000
women died of breast cancer in the United States in 2008.
A Phase 2
clinical development program for NKTR-102 was initiated in early 2009 to
evaluate the efficacy and safety of NKTR-102 monotherapy versus irinotecan in
second-line colorectal cancer patients with the KRAS mutant gene. The primary
endpoint of the Phase 2 placebo-controlled trial of NKTR-102 in colorectal
cancer will be a clinically meaningful improvement in progression-free survival
as compared to standard irinotecan monotherapy. According to recent data
presented at the American Society of Clinical Oncology in 2008, it is estimated
that up to 45% of colorectal cancer cases have this mutation in the KRAS gene
and do not respond to EGFR-inhibitors, such as cetuximab. We expect
this Phase 2 clinical trial to continue throughout 2010. A Phase 2a
study of NKTR-102 was completed in 2009 to evaluate NKTR-102 in combination with
cetuximab in 18 patients with refractory solid tumors, primarily
gastrointestinal-related cancers, in order to establish the recommended Phase 2
dose. According to the National Comprehensive Clinical Network,
colorectal cancer is the most frequently diagnosed cancer in men and women in
the United States. In 2008, it is estimated that over 108,000 new cases of colon
cancer and approximately 40,780 cases of rectal cancer occurred. During the same
year, it is estimated that 49,960 people died from colon and rectal
cancer.
NKTR-105
(PEGylated docetaxel)
NKTR-105
is a PEGylated conjugate form of docetaxel, an anti-neoplastic agent belonging
to the taxoid family that acts by disrupting the microtubular network in cells.
Docetaxel is a major chemotherapy agent approved for use in five different
cancer indications: breast, non-small cell lung, prostate, gastric, and head and
neck. Annual sales of docetaxel in 2007 exceeded $2 billion. Anti-cancer agents,
such as docetaxel, typically have suboptimal pharmacokinetic profiles
which can limit their therapeutic value. Docetaxel frequently causes
neutropenia. Patients are advised the treatment with corticosteroids is required
in conjunction with docetaxel dosing and some neutropenia patients require
pre-treatment with corticosterioids. Our advanced polymer conjugation
technology can be used to optimize the bioactivity of these drugs and increase
the sustained exposure of active drug to tumor cells in the body.
NKTR-105
is currently being evaluated in a Phase 1 clinical trial in cancer patients that
began in February 2009. The study will assess the safety, pharmacokinetics, and
anti-tumor activity of NKTR-105 in approximately 30 patients with refractory
solid tumors who have failed all prior available therapies. We
expect to have results from this study in 2010.
NKTR-181
(abuse deterrent, tamper-resistant opioid)
NKTR-181
is being developed as a safer opioid with reduced potential for abuse engineered
using our advanced polymer conjugation technology platform. By regulating entry
of the drug into the CNS, this polymer-conjugate opioid drug candidate is
designed to have potent analgesia with the potential for fewer side effects
associated with sedation, a reduced risk of death due to respiratory depression,
and less euphoria associated with administration, resulting in an safer,
abuse-deterrent analgesic. The stable opioid-polymer conjugate drug is also
designed to be tamper-resistant to reduce the potential for diversion for
illicit reprocessing. This program is in the early stages of research and
preclinical development.
NKTR-194
(non-scheduled opioid)
NKTR-194
is an opioid designed using our advanced polymer conjugation technology
platform to be nearly totally excluded from the CNS and therefore act only
against peripheral pain. This approach has the potential to avoid certain CNS
side effects, gastrointestinal bleeding and cardiovascular risks associated with
NSAIDs and COX-2 inhibitors currently used to treat moderate peripheral pain.
This program is in the early stages of research and preclinical
development.
NKTR-171 (tricyclic antidepressant-polymer
conjugate)
NKTR-171
is a drug candidate designed to treat neuropathic pain without the CNS side
effects associated with the use of tricyclic antidepressants. The product is
being developed using our advanced polymer conjugate technology to near totally
preclude the drug from penetrating the CNS. This program is in the early
stages of research and preclinical development.
11
NKTR-140
(protease inhibitor-polymer conjugate)
NKTR-140
is a protease inhibitor product candidate to treat human immunodeficiency virus
(HIV), which can lead to acquired immunodeficiency syndrome or AIDS. The product
candidate was developed using our advanced small molecule polymer conjugate
technology. This product candidate is designed to have improved potency as
compared to leading protease inhibitors used in clinical practice today, and
also to eliminate the need for a co-administered protease inhibitor booster,
such as ritonavir. This program is in the early stages of research
and preclinical development.
Overview
of Select Technology Licensing Collaborations and Programs
Hematide™, Agreement with Affymax,
Inc.
In April
2004, we entered into a license, manufacturing and supply agreement with
Affymax, Inc. (Affymax), under which we granted Affymax a worldwide,
non-exclusive license to certain of our proprietary PEGylation technology to
develop, manufacture and commercialize Hematide. We currently manufacture our
proprietary PEGylation materials for Affymax on a fixed price basis subject to
annual adjustments. Affymax has an option to convert this manufacturing pricing
arrangement to cost plus at any time prior to the date the New Drug Application
(NDA) for Hematide is submitted to the Food and Drug Administration (FDA). In
addition, Affymax is responsible for all clinical development, regulatory and
commercialization expenses and we are entitled to development milestones and
royalties on net sales of Hematide. We will share a portion of our future
royalty payments with Enzon Pharmaceuticals, Inc. Our right to
receive royalties in any particular country will expire upon the later of ten
years after the first commercial sale of the product in that country or the
expiration of patent rights in that particular country. The agreement expires on
a country-by-country basis upon the expiration of Affymax’s royalty obligations.
The agreement may also be terminated by either party for the other party’s
continued material breach after a cure period or by us in the event that Affymax
challenges the validity or enforceability of any patent licensed to them under
the agreement.
Levadex™,
Agreement with MAP Pharmaceuticals
In June
2004, we entered into a license agreement with MAP Pharmaceuticals which
includes a worldwide, exclusive license, to certain of our patents and other
intellectual property rights to develop and commercialize a formulation of
dihydroergotamine for administration to patients via the pulmonary or nasal
delivery route. Under the terms of the agreement, we have the right
to receive certain development milestone payments and royalties based on net
sales of Levadex. Our right to receive royalties in any
particular country will expire upon the later of (i) ten years after first
commercial sale in that country, (ii) the date upon the licensed know-how
becomes known to the general public, and (iii) expiration of certain patent
claims, each on a country-by-country basis. Either party may
terminate the agreement upon a material, uncured default of the other
party.
Hemophilia
Programs, Agreement with Subsidiaries of Baxter International
In
September 2005, we entered into an exclusive research, development, license and
manufacturing and supply agreement with Baxter Healthcare SA and Baxter
Healthcare Corporation (Baxter) to develop products with an extended half-life
for the treatment and prophylaxis of Hemophilia A patients using our PEGylation
technology. In December 2007, we expanded our agreement with Baxter to include
the license of our PEGylation technology and proprietary PEGylation methods with
the potential to improve the half-life of any future products Baxter may develop
for the treatment and prophylaxis of Hemophilia B patients. Under the terms of
the agreement, we are entitled to research and development funding, and we
manufacture our proprietary PEGylation materials for Baxter on a cost plus
basis. Baxter is responsible for all clinical development, regulatory, and
commercialization expenses. In relation to Hemophilia A, we are entitled to
development milestone payments and royalties on net sales varying by product and
country of sale. Our right to receive these royalties in any particular country
will expire upon the later of ten years after the first commercial sale of the
product in that country or the expiration of patent rights in certain designated
countries or in that particular country. In relation to Hemophilia B, we are
entitled to development and sales milestone payments and royalties on net sales
varying by product and country of sale. Our right to receive these royalties in
any particular country will expire upon the later of twelve years after the
first commercial sale of the product in that country or the expiration of patent
rights in certain designated countries or in that particular country. The
agreement expires in relation to a particular product and country upon the
expiration of all of Baxter’s royalty obligations related to such product and
country. The agreement may also be terminated by either party for the other
party’s material breach or insolvency, provided that such other party has been
given a chance to cure or remedy such breach or insolvency. Subject to certain
limitations as to time, and possible termination fee payment obligations, Baxter
also has the right to terminate the agreement for convenience. We have the right
to terminate the agreement or convert Baxter’s license from exclusive to
non-exclusive in the event Baxter fails to comply with certain diligence
obligations.
12
Cipro
Inhale, Assigned to Novartis as of December 31, 2008
We were a
party to a collaborative research, development and commercialization agreement
with Bayer Schering Pharma AG related to the development of an inhaled powder
formulation of Ciprofloxacin for the treatment of chronic lung infections caused
by Pseudomonas aeruginosa
in cystic fibrosis patients. As of December 31, 2008, we assigned the
collaborative research, development and commercialization agreement to Novartis
Pharma AG in connection with the closing of the asset sale transaction. We
maintain the right to receive certain potential royalties in the future based on
net product sales if Cipro Inhale receives regulatory approval and is
successfully commercialized.
Overview
of Select Licensing Partnerships for Approved Products
All of
the approved products today that use our technology platforms are a result of
licensing collaborations with partners. We also have a number of product
candidates in clinical development by our partners that use our technology or
involve rights over which we have patents or other proprietary intellectual
property. In a typical collaboration involving our PEGylation technology, we
license our proprietary intellectual property related to our PEGylation
technology or proprietary conjugated drug molecules in consideration for upfront
payments, development milestone payments and royalties from sales of the
resulting commercial product as well as sales milestones. We also manufacture
and supply our proprietary PEGylation materials to our partners.
Neulasta®, Agreement with Amgen,
Inc.
In July
1995, we entered into a non-exclusive supply and license agreement with Amgen,
Inc. (Amgen), pursuant to which we license our proprietary PEGylation technology
to be used in the development and manufacture of Neulasta. Neulasta selectively
stimulates the production of neutrophils that are depleted by cytotoxic
chemotherapy, a condition called neutropenia that makes it more difficult for
the body to fight infections. We manufacture and supply our
proprietary PEGylation materials for Amgen on a fixed price basis. The term of
the agreement is for a fixed duration with a limited number of renewal options.
This supply term is scheduled to expire in 2010 unless extended. The
parties are currently discussing various extension alternatives.
PEGASYS®, Agreement with F. Hoffmann-La
Roche Ltd
In
February 1997, we entered into a license, manufacturing and supply agreement
with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche), under which we
granted Roche a worldwide, exclusive license to use certain PEGylation materials
to manufacture and commercialize a certain class of products, of which PEGASYS
is the only product currently commercialized. PEGASYS is approved in the U.S.,
E.U. and other countries for the treatment of Hepatitis C and is designed to
help the patient’s immune system fight the Hepatitis C virus. As a
result of Roche exercising a license extension option in December 2009,
beginning in 2010 Roche has the right to manufacture all of its requirements for
our proprietary PEGylation materials for PEGASYS and we would supply raw
materials or perform additional manufacturing, if any, only on an as requested
basis. The agreement expires on the later of January 10, 2015 or the
expiration of our last relevant patent containing a valid claim.
Somavert®, Agreement with Pfizer,
Inc.
In
January 2000, we entered into a license, manufacturing and supply agreement with
Sensus Drug Development Corporation (subsequently acquired by Pharmacia Corp. in
2001 and then acquired by Pfizer, Inc. in 2003), for the PEGylation of Somavert
(pegvisomant), a human growth hormone receptor antagonist for the treatment of
acromegaly. We currently manufacture our proprietary PEGylation reagent for
Pfizer on a price per gram basis. The agreement expires on the later of ten
years from the grant of first marketing authorization in the designated
territory, which occurred in March 2003, or the expiration of our last relevant
patent containing a valid claim. In addition, Pfizer may terminate the agreement
if marketing authorization is withdrawn or marketing is no longer feasible due
to certain circumstances, and either party may terminate for cause if certain
conditions are met.
PEG-Intron®, Agreement with Merck (formerly
Schering-Plough Corporation)
In
February 2000, we entered into a manufacturing and supply agreement with
Schering-Plough Corporation (Schering) for the manufacture and supply of our
proprietary PEGylation materials to be used by Schering in production of a
pegylated recombinant human interferon-alpha (PEG-Intron). PEG-Intron is a
treatment for patients with Hepatitis C. We currently manufacture our
proprietary PEGylation materials for Schering on a price per gram basis. The
agreement is for a fixed duration with renewal terms conditioned upon mutual
agreement. We have sent notice that we do not intend to renew this
agreement and under the terms of the agreement it expires in
2011.
13
Macugen®,
Agreement with Eyetech Inc.
In 2002,
we entered into a license, manufacturing and supply agreement with Eyetech Inc.
(Eyetech) in 2005, pursuant to which we license our proprietary PEGylation
technology for the development and commercialization of Macugen®, a
PEGylated anti-vascular endothelial growth factor aptamer currently approved in
the U.S. and E.U. for use in treating age-related macular degeneration. We
currently manufacture our proprietary PEGylation materials for Eyetech on a
price per gram basis. Under the terms of the agreement, we will receive
royalties on net product sales in any particular country covered by a valid
patent claim for the longer of ten years from the date of the first commercial
sale of the product in that country or the manufacture, use or sale of such
product in that country. We share a portion of the payments received under this
agreement with Enzon. The agreement expires upon the expiration of
our last relevant patent containing a valid claim. In addition, Eyetech may
terminate the agreement if marketing authorization is withdrawn or marketing is
no longer feasible due to certain circumstances, and either party may terminate
for cause if certain conditions are met.
CIMZIA™, Agreement with UCB
Pharma
In
December 2000, we entered into a license, manufacturing and supply agreement for
CIMZIA™ (certolizumab pegol, CDP870) with Celltech Chiroscience Ltd., which was
acquired by UCB Pharma (UCB) in 2004. Under the terms of the agreement, UCB is
responsible for all clinical development, regulatory, and commercialization
expenses. We have the right to receive manufacturing revenue on a cost-plus
basis and royalties on net product sales. We are entitled to receive royalties
on net sales of the CIMZIA™ product in any particular country for the longer of
ten years from the first commercial sale of the product in that country or the
expiration of patent rights in that particular country. We share a portion of
the payments we receive from UCB with Enzon. CIMZIA™ is currently
approved in the treatment of Crohn’s Disease in the U.S and the treatment of
rheumatoid arthritis in EMEA. UCB is also conducting Phase 2 clinical trials on
CIMZIA™ for psoriasis. The agreement expires upon the expiration of
all of UCB’s royalty obligations, provided that the agreement can be extended
for successive two year renewal periods upon mutual agreement of the parties. In
addition, UCB may terminate the agreement should it cease the development and
marketing of CIMZIA™ and either party may terminate for cause under certain
conditions.
MIRCERA® (C.E.R.A.) (Continuous
Erythropoietin Receptor Activator), Agreement with F. Hoffmann-La Roche
Ltd
In
December 2000, we entered into a license, manufacturing and supply agreement
with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche), which was
amended and restated in its entirety in December 2005. Pursuant to the
agreement, we license our proprietary PEGylation materials for use in the
development and manufacture of Roche’s MIRCERA product. MIRCERA is a novel
continuous erythropoietin receptor activator indicated for the treatment of
anemia associated with chronic kidney disease in patients on dialysis and
patients not on dialysis. We are entitled to receive royalties on net sales of
the MIRCERA product in any particular country for the longer of ten years from
the first commercial sale of the product in that country or the expiration of
patent rights in that particular country. The agreement expires upon the
expiration of all of Roche’s royalty obligations, unless earlier terminated by
Roche for convenience or by either party for cause under certain
conditions.
In May
2007, MIRCERA was approved in the EU and the product was subsequently launched
by Roche in the EU in August of 2007. In November 2007, the FDA approved Roche’s
Biologics License Application (BLA) for MIRCERA but the product has not been
launched in the U.S. as a result of patent-related issues. In October
2008, a federal district court ruled in favor of Amgen Inc. in a patent
infringement lawsuit involving MIRCERA and issued a permanent injunction which
prevents Roche from marketing or selling MIRCERA in the U.S. even though the FDA
approved MIRCERA. In December 2009, the U.S. District Court for the District of
Massachusetts entered a final judgment and permanent injunction and Roche and
Amgen entered into a settlement and limited license agreement which allows Roche
to begin selling MIRCERA in the U.S. in July 2014.
14
Significant
Developments in our Business that Occurred in 2008
Exit
from the Inhaled Insulin Programs
In 1995,
we entered into a collaborative development and licensing agreement with Pfizer
to develop and market Exubera® and, in
2006 and 2007, we entered into a series of interim letter agreements with Pfizer
to develop a next generation form of dry powder inhaled insulin and proprietary
inhaler device, also known as NGI. In January 2006, Exubera received marketing
approval in the U.S. and EU for the treatment of adults with Type 1 and Type 2
diabetes. Under the collaborative development and licensing agreement, Pfizer
had sole responsibility for marketing and selling Exubera. We performed all of
the manufacturing of the Exubera dry powder insulin, and we supplied Pfizer with
the Exubera inhalers through third party contract manufacturers (Bespak Europe
Ltd. and Tech Group, Inc.). Our total revenue from Pfizer was nil,
nil and $189.1 million, representing 0%, 0% and 64% of total revenue, for the
years ended December 31, 2009, 2008, and 2007, respectively.
On
October 18, 2007, Pfizer announced that it was exiting the Exubera business and
gave notice of termination under our collaborative development and licensing
agreement. On November 9, 2007, we entered into a termination agreement and
mutual release with Pfizer. Under this agreement we received a one-time payment
of $135.0 million in November 2007 from Pfizer in satisfaction of all
outstanding contractual obligations under our then-existing agreements relating
to Exubera and NGI. All agreements between Pfizer and us related to Exubera and
NGI, other than the termination agreement and mutual release and a related
interim Exubera manufacturing maintenance letter, terminated on November 9,
2007. In February 2008, we entered into a termination agreement with Bespak and
Tech Group pursuant to which we paid an aggregate of $39.9 million in
satisfaction of outstanding accounts payable and termination costs and expenses
that were due under the Exubera inhaler contract manufacturing agreement. We
also entered into a maintenance agreement with both Pfizer and Tech Group to
preserve key personnel and manufacturing capacity to support potential future
Exubera inhaler manufacturing if we found a new partner for the inhaled insulin
program.
On April
9, 2008, we announced that we had ceased all negotiations with potential
partners for Exubera and NGI as a result of new data analysis from ongoing
clinical trials conducted by Pfizer which indicated an increase in the number of
new cases of lung cancer in Exubera patients who were former smokers as compared
to patients in the control group who were not former smokers. In April 2008, we
ceased all spending associated with maintaining Exubera manufacturing capacity
and any further NGI development, including, but not limited to, terminating the
Exubera manufacturing capacity maintenance arrangements with Pfizer and Tech
Group.
Asset
Sale to Novartis
On
December 31, 2008, we completed the sale of certain assets related to our
pulmonary business, associated technology and intellectual property to Novartis
Pharma AG and Novartis Pharmaceuticals Corporation (together referred to as
Novartis) for a purchase price of $115.0 million in cash (Novartis Pulmonary
Asset Sale). Under the terms of the transaction, we transferred to Novartis
certain assets and obligations related to our pulmonary technology, development
and manufacturing operations including:
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•
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dry
powder and liquid pulmonary technology platform including but not limited
to our pulmonary inhalation devices, formulation technology, manufacturing
technology and related intellectual
property;
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•
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capital
equipment, information systems and facility lease obligations for our
pulmonary development and manufacturing facility in San Carlos,
California;
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•
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manufacturing
and associated development services payments for the Cipro Inhale
program;
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•
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manufacturing
and royalty rights to the Tobramycin Inhalation Powder (TIP) program
through the termination of our collaboration agreement with
Novartis;
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certain
other interests that we had in two private companies;
and
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approximately
140 of our personnel primarily dedicated to our pulmonary technology,
development programs, and manufacturing
operations.
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In
consideration for the transfer of the above described pulmonary assets, we
received $115.0 million in cash on December 31, 2008. In addition, we retained
all of our rights to BAY41-6551, partnered with Bayer Healthcare LLC, certain
royalty rights for the Cipro Inhale development program partnered with Bayer
Schering Pharma AG, and certain intellectual property rights specific to inhaled
insulin.
15
In
connection with the Novartis Pulmonary Asset Sale, we also entered into an
Exclusive License Agreement with Novartis Pharma. Pursuant to the Exclusive
License Agreement, Novartis Pharma granted back to us an exclusive, irrevocable,
perpetual, non-transferable, royalty-free and worldwide license under certain
specific patent rights and other related intellectual property rights acquired
by Novartis Pharma from Nektar in the transaction, as well as certain
improvements or modifications thereto that are made by Novartis Pharma after the
closing. Certain of such patent rights and other related intellectual property
rights relate to our development program for NKTR-063 or are necessary for us to
satisfy certain of our continuing contractual obligations to third parties,
including in connection with development, manufacture, sale, and
commercialization activities related to BAY41-6551. We also entered into a
service agreement pursuant to which we have subcontracted to Novartis certain
services to be performed related to our partnered program for BAY41-6551 and a
transition services agreement pursuant to which Novartis and we will provide
each other with specified services for limited time periods following the
closing of the Novartis Pulmonary Asset Sale to facilitate the transition of the
acquired assets and business from us to Novartis.
Research
and Development
Our total
Research and development expenditures can be disaggregated into the following
significant types of expenses (in millions):
Years ended December 31,
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2009
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2008
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2007
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Salaries
and employee benefits
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$ | 29.4 | $ | 58.4 | $ | 70.7 | ||||||
Stock
compensation expense
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3.6 | 4.6 | 6.3 | |||||||||
Facility
and equipment
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9.9 | 25.9 | 33.9 | |||||||||
Outside
services, including Contract Research Organizations
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38.9 | 40.2 | 26.8 | |||||||||
Supplies,
including clinical trial materials
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10.4 | 19.0 | 10.8 | |||||||||
Travel,
lodging, and meals
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1.7 | 3.3 | 2.2 | |||||||||
Other
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1.2 | 3.0 | 2.9 | |||||||||
Research
and development
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$ | 95.1 | $ | 154.4 | $ | 153.6 |
Manufacturing
and Supply
We have a
manufacturing facility located in Huntsville, Alabama related to our PEGylation
and advanced polymer conjugate technologies. This facility is capable of
manufacturing PEGylation derivatives and starting materials for active
pharmaceutical ingredients (APIs). The facility is also used to produce APIs for
clinical development for our proprietary product candidates that utilize our
PEGylation and advanced polymer conjugate technology. The facility and
associated equipment is designed and operated to be in compliance with the
guidelines of the International Conference on Harmonization of Technical
Requirements for Registration of Pharmaceuticals for Human Use (ICH) applicable
to APIs (ICH Q7A guidelines).
We source
drug starting materials for our manufacturing activities from one or more
suppliers. If we are responsible for manufacturing activities under a
collaboration arrangement, we typically source drug starting materials from the
collaboration partner. For the drug starting materials necessary for our
proprietary drug candidate development, we have agreements for the supply of
such drug components with drug suppliers that we believe have sufficient
capacity to meet our demands. However, from time to time, we source critical raw
materials from one or a limited number of suppliers and there is a risk that if
such supply were interrupted, it would materially harm our business. In
addition, we typically order raw materials on a purchase order basis and do not
enter into long-term dedicated capacity or minimum supply
arrangements.
Prior to
the closing of the Novartis Pulmonary Asset Sale on December 31, 2008, we
operated a drug powder manufacturing and packaging facility in San Carlos,
California capable of producing drug powders in quantities sufficient for
clinical trials of product candidates utilizing our pulmonary
technology. As part of the Novartis Pulmonary Asset Sale, we
transferred this manufacturing facility and the related operations, and Novartis
hired approximately 140 of the related supporting personnel, as of December 31,
2008.
16
Government
Regulation
The
research and development, clinical testing, manufacture and marketing of
products using our technologies are subject to regulation by the FDA and by
comparable regulatory agencies in other countries. These national agencies and
other federal, state and local entities regulate, among other things, research
and development activities and the testing (in vitro, in animals, and in human
clinical trials), manufacture, labeling, storage, recordkeeping, approval,
marketing, advertising and promotion of our products.
The
approval process required by the FDA before a product using any of our
technologies may be marketed in the U.S. depends on whether the chemical
composition of the product has previously been approved for use in other dosage
forms. If the product is a new chemical entity that has not been previously
approved, the process includes the following:
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extensive
preclinical laboratory and animal
testing;
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•
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submission
of an Investigational New Drug application (IND) prior to commencing
clinical trials;
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adequate
and well-controlled human clinical trials to establish the safety and
efficacy of the drug for the intended indication;
and
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submission
to the FDA of an NDA for approval of a drug, a BLA for approval of a
biological product or a Premarket Approval Application (PMA) or Premarket
Notification 510(k) for a medical device product (a
510(k)).
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If the
active chemical ingredient has been previously approved by the FDA, the approval
process is similar, except that certain preclinical tests relating to systemic
toxicity normally required for the IND and NDA or BLA may not be necessary if
the company has a right of reference to such data or is eligible for approval
under Section 505(b)(2) of the Federal Food, Drug, and Cosmetic
Act.
Preclinical
tests include laboratory evaluation of product chemistry and animal studies to
assess the safety and efficacy of the product and its chosen formulation.
Preclinical safety tests must be conducted by laboratories that comply with FDA
good laboratory practices (GLP) regulations. The results of the preclinical
tests for drugs, biological products and combination products subject to the
primary jurisdiction of the FDA’s Center for Drug Evaluation and Research (CDER)
or Center for Biologics Evaluation and Research (CBER) are submitted to the FDA
as part of the IND and are reviewed by the FDA before clinical trials can begin.
Clinical trials may begin 30 days after receipt of the IND by the FDA, unless
the FDA raises objections or requires clarification within that
period.
Clinical
trials involve the administration of the drug to healthy volunteers or patients
under the supervision of a qualified, identified medical investigator according
to a protocol submitted in the IND for FDA review. Drug products to be used in
clinical trials must be manufactured according to current good manufacturing
practices (cGMP). Clinical trials are conducted in accordance with protocols
that detail the objectives of the study and the parameters to be used to monitor
participant safety and product efficacy as well as other criteria to be
evaluated in the study. Each protocol is submitted to the FDA in the
IND.
Apart
from the IND process described above, each clinical study must be reviewed by an
independent Institutional Review Board (IRB) and the IRB must be kept current
with respect to the status of the clinical study. The IRB considers, among other
things, ethical factors, the potential risks to subjects participating in the
trial and the possible liability to the institution where the trial is
conducted. The IRB also reviews and approves the informed consent form to be
signed by the trial participants and any significant changes in the clinical
study.
Clinical
trials are typically conducted in three sequential phases. Phase 1 involves the
initial introduction of the drug into healthy human subjects (in most cases) and
the product generally is tested for tolerability, pharmacokinetics, absorption,
metabolism and excretion. Phase 2 involves studies in a limited patient
population to:
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•
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determine
the preliminary efficacy of the product for specific targeted
indications;
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determine
dosage and regimen of administration;
and
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identify
possible adverse effects and safety
risks.
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If Phase
2 trials demonstrate that a product appears to be effective and to have an
acceptable safety profile, Phase 3 trials are undertaken to evaluate the further
clinical efficacy and safety of the drug and formulation within an expanded
patient population at geographically dispersed clinical study sites and in large
enough trials to provide statistical proof of efficacy and tolerability. The
FDA, the clinical trial sponsor, the investigators or the IRB may suspend
clinical trials at any time if any one of them believes that study participants
are being subjected to an unacceptable health risk. In some cases, the FDA and
the drug sponsor may determine that Phase 2 trials are not needed prior to
entering Phase 3 trials.
17
Following
a series of formal and informal meetings between the drug sponsor and the
regulatory agencies, the results of product development, preclinical studies and
clinical studies are submitted to the FDA as an NDA or BLA for approval of the
marketing and commercial shipment of the drug product. The FDA may deny approval
if applicable regulatory criteria are not satisfied or may require additional
clinical or pharmaceutical testing or requirements. Even if such data are
submitted, the FDA may ultimately decide that the NDA or BLA does not satisfy
all of the criteria for approval. Additionally, the approved labeling may
narrowly limit the conditions of use of the product, including the intended
uses, or impose warnings, precautions or contraindications which could
significantly limit the potential market for the product. Further, as a
condition of approval, the FDA may impose post-market surveillance, or Phase 4,
studies or risk management programs. Product approvals, once obtained, may be
withdrawn if compliance with regulatory standards is not maintained or if safety
concerns arise after the product reaches the market. The FDA may require
additional post-marketing clinical testing and pharmacovigilance programs to
monitor the effect of drug products that have been commercialized and has the
power to prevent or limit future marketing of the product based on the results
of such programs. After approval, there are ongoing reporting obligations
concerning adverse reactions associated with the product, including expedited
reports for serious and unexpected adverse events.
Each
manufacturer of drug product for the U.S. market must be registered with the FDA
and typically is inspected by the FDA prior to NDA or BLA approval of a drug
product manufactured by such establishment. Establishments handling controlled
substances must also be licensed by the U.S. Drug Enforcement Administration.
Manufacturing establishments of U.S. marketed products are subject to
inspections by the FDA for compliance with cGMP and other U.S. regulatory
requirements. They are also subject to U.S. federal, state, and local
regulations regarding workplace safety, environmental protection and hazardous
and controlled substance controls, among others.
A number
of the drugs we are developing are already approved for marketing by the FDA in
another form or using another delivery system. We believe that, when working
with drugs approved in other forms, the approval process for products using our
alternative drug delivery or formulation technologies may involve less risk and
require fewer tests than new chemical entities do. However, we expect that our
formulations will often use excipients not currently approved for use. Use of
these excipients will require additional toxicological testing that may increase
the costs of, or length of time needed to, gain regulatory approval. In
addition, as they relate to our products, regulatory procedures may change as
regulators gain relevant experience, and any such changes may delay or increase
the cost of regulatory approvals.
For
product candidates currently under development utilizing pulmonary technology,
the pulmonary inhaler devices are considered to be part of a drug and device
combination for deep lung delivery of each specific molecule. The FDA will make
a determination as to the most appropriate center and division within the agency
that will assume prime responsibility for the review of the applicable
applications, which would consist of an IND and an NDA or BLA where CDER or CBER
are determined to have primary jurisdiction or an investigational device
exemption application and PMA or 510(k) where the Center for Devices and
Radiological Health (CDRH) is determined to have primary jurisdiction. In the
case of our product candidates, CDER in consultation with CDRH could be involved
in the review. The assessment of jurisdiction within the FDA is based upon the
primary mode of action of the drug or the location of the specific expertise in
one of the centers.
Where
CDRH is determined to have primary jurisdiction over a product, 510(k) clearance
or PMA approval is required. Medical devices are classified into one of three
classes—Class I, Class II, or Class III—depending on the degree of risk
associated with each medical device and the extent of control needed to ensure
safety and effectiveness. Devices deemed to pose lower risks are placed in
either Class I or II, which requires the manufacturer to submit to the FDA a
Premarket Notification requesting permission to commercially distribute the
device. This process is known as 510(k) clearance. Some low risk devices are
exempted from this requirement. Devices deemed by the FDA to pose the greatest
risk, such as life-sustaining, life-supporting or implantable devices, or
devices deemed not substantially equivalent to a previously cleared 510(k)
device are placed in Class III, requiring PMA approval.
To date,
our partners have generally been responsible for clinical and regulatory
approval procedures, but we may participate in this process by submitting to the
FDA a drug master file developed and maintained by us which contains data
concerning the manufacturing processes for the inhaler device or drug. For our
proprietary products, we prepare and submit an IND and are responsible for
additional clinical and regulatory procedures for product candidates being
developed under an IND. The clinical and manufacturing development and
regulatory review and approval process generally takes a number of years and
requires the expenditure of substantial resources. Our ability to manufacture
and market products, whether developed by us or under collaboration agreements,
ultimately depends upon the completion of satisfactory clinical trials and
success in obtaining marketing approvals from the FDA and equivalent foreign
health authorities.
18
Sales of
our products outside the U.S. are subject to local regulatory requirements
governing clinical trials and marketing approval for drugs. Such requirements
vary widely from country to country.
In the
U.S., under the Orphan Drug Act, the FDA may grant orphan drug designation to
drugs intended to treat a rare disease or condition, which is generally a
disease or condition that affects fewer than 200,000 individuals in the U.S. The
company that obtains the first FDA approval for a designated orphan drug for a
rare disease receives marketing exclusivity for use of that drug for the
designated condition for a period of seven years. In addition, the Orphan Drug
Act provides for protocol assistance, tax credits, research grants, and
exclusions from user fees for sponsors of orphan products. Once a product
receives orphan drug exclusivity, a second product that is considered to be the
same drug for the same indication may be approved during the exclusivity period
only if the second product is shown to be “clinically superior” to the original
orphan drug in that it is more effective, safer or otherwise makes a “major
contribution to patient care” or the holder of exclusive approval cannot assure
the availability of sufficient quantities of the orphan drug to meet the needs
of patients with the disease or condition for which the drug was
designated.
In the
U.S., the FDA may grant Fast Track designation to a product candidate, which
allows the FDA to expedite the review of new drugs that are intended for serious
or life-threatening conditions and that demonstrate the potential to address
unmet medical needs. An important feature of Fast Track designation is that it
emphasizes the critical nature of close, early communication between the FDA and
the sponsor company to improve the efficiency of product
development.
Patents
and Proprietary Rights
We invest
a significant portion of our resources in the creation and development of new
drug compounds that serve unmet needs in the treatment of patients. In doing so,
we create intellectual property. As part of our strategy to secure our
intellectual property created by these efforts, we routinely apply for patents,
rely on trade secret protection, and enter into contractual obligations with
third parties. When appropriate, we will defend our intellectual property,
taking any and all legal remedies available to us, including, for example,
asserting patent infringement, trade secret misappropriation and breach of
contract claims. As of January 1, 2010, we owned approximately 100 U.S. and 380
foreign patents. Currently, we have over approximately 100 patent applications
pending in the U.S. and 480 pending in other countries.
A focus
area of our current drug creation and development efforts centers on our
innovations in and improvements to our PEGylation and advanced polymer conjugate
technology platforms. In this area, our patent portfolio contains patents and
patent applications that encompass our PEGylation and advanced polymer conjugate
technology platforms, some of which we acquired in our acquisition of Shearwater
Corporation in June 2001. More specifically, our patents and patent applications
cover polymer architecture, drug conjugates, formulations, methods of making
polymers and polymer conjugates, and methods of administering polymer
conjugates. Our patent strategy is to file patent applications on innovations
and improvements to cover a significant majority of the major pharmaceutical
markets in the world. Generally, patents have a term of twenty years from the
earliest priority date (assuming all maintenance fees are paid). In some
instances, patent terms can be increased or decreased, depending on the laws and
regulations of the country or jurisdiction that issued that patent.
In
January 2002, we entered into a Cross-License and Option Agreement with Enzon
Pharmaceuticals, Inc., pursuant to which we and Enzon provided certain licenses
to selected portions of each party’s PEGylation patent portfolio. In
certain cases, we have the option to license certain of Enzon’s PEGylation
patents for use in our proprietary products or for sublicenses to third parties
in each case in exchange for payments to Enzon based on manufacturing profits,
revenue share or royalties on net sales if a designated product candidate is
approved in one or more markets.
In
connection with the Novartis Pulmonary Asset Sale, as of December 31, 2008, we
entered into an exclusive license agreement with Novartis Pharma. Pursuant to
the exclusive license agreement, Novartis Pharma grants back to us an exclusive,
irrevocable, perpetual, royalty-free and worldwide license under certain
specific patent rights and other related intellectual property rights acquired
by Novartis from us in the Novartis Pulmonary Asset Sale, as well as certain
improvements or modifications thereto that are made by Novartis. Certain of such
patent rights and other related intellectual property rights relate to our
development program for NKTR-063 or are necessary for us to satisfy certain
continuing contractual obligations to third parties, including in connection
with development, manufacture, sale, and commercialization activities related to
BAY41-6551 partnered with Bayer Healthcare LLC.
19
The
patent positions of pharmaceutical and biotechnology companies, including ours,
involve complex legal and factual issues. There can be no assurance that the
patents we apply for will be issued to us or that the patents that are issued to
us will be held valid and enforceable in a court of law. Even for patents that
are enforceable, we anticipate that any attempt to enforce our patents would be
time consuming and costly. Additionally, the coverage claimed in a patent
application can be significantly reduced before the patent is issued. As a
consequence, we do not know whether any of our pending patent applications will
be granted with broad coverage or whether the claims that eventually issue, or
those that have issued, will be circumvented. Since publication of discoveries
in scientific or patent literature often lag behind actual discoveries, we
cannot be certain that we were the first inventor of inventions covered by our
patents or patent applications or that we were the first to file patent
applications for such inventions. Moreover, we may have to participate in
interference proceedings in the U.S. Patent and Trademark Office, which could
result in substantial cost to us, even if the eventual outcome is favorable. An
adverse outcome could subject us to significant liabilities to third parties,
require disputed rights to be licensed from or to third parties or require us to
cease using the technology in dispute. Please refer to Item 1A, Risk
Factors, including but not limited to “We may not be able to obtain intellectual
property licenses related to the development of our technology on a commercially
reasonable basis, if at all,” and “If any of our pending patent applications do
not issue, or are deemed invalid following issuance, we may lose valuable
intellectual property protection.”
U.S. and
foreign patent rights and other proprietary rights exist that are owned by third
parties and relate to pharmaceutical compositions and reagents, medical devices
and equipment and methods for preparation, packaging and delivery of
pharmaceutical compositions. We cannot predict with any certainty which, if any,
of these rights will be considered relevant to our technology by authorities in
the various jurisdictions where such rights exist, nor can we predict with
certainty which, if any, of these rights will or may be asserted against us by
third parties. We could incur substantial costs in defending ourselves and our
partners against any such claims. Furthermore, parties making such claims may be
able to obtain injunctive or other equitable relief, which could effectively
block our ability to develop or commercialize some or all of our products in the
U.S. and abroad and could result in the award of substantial damages. In the
event of a claim of infringement, we or our partners may be required to obtain
one or more licenses from third parties. There can be no assurance that we can
obtain a license to any technology that we determine we need on reasonable
terms, if at all, or that we could develop or otherwise obtain alternative
technology. The failure to obtain licenses if needed may have a material adverse
effect on our business, results of operations and financial
condition.
We also
rely on trade secret protection for our confidential and proprietary
information. No assurance can be given that we can meaningfully protect our
trade secrets. Others may independently develop substantially equivalent
confidential and proprietary information or otherwise gain access to, or
disclose, our trade secrets.
In
certain situations in which we work with drugs covered by one or more patents,
our ability to develop and commercialize our technologies may be affected by
limitations in our access to these proprietary drugs. Even if we believe we are
free to work with a proprietary drug, we cannot guarantee we will not be accused
of, or determined to be, infringing a third party’s rights and be prohibited
from working with the drug or found liable for damages. Any such restriction on
access or liability for damages would have a material adverse effect on our
business, results of operations and financial condition.
It is our
policy to require our employees and consultants, outside scientific
collaborators, sponsored researchers and other advisors who receive confidential
information from us to execute confidentiality agreements upon the commencement
of employment or consulting relationships with us. These agreements provide that
all confidential information developed or made known to the individual during
the course of the individual’s relationship with us is to be kept confidential
and not disclosed to third parties except in specific circumstances. The
agreements provide that all inventions conceived by an employee shall be our
property. There can be no assurance, however, that these agreements will provide
meaningful protection or adequate remedies for our trade secrets in the event of
unauthorized use or disclosure of such information.
Our
revenue is derived from our collaboration agreements with partners, under which
we may receive contract research payments, milestone payments based on clinical
progress, regulatory progress or net sales achievements, royalties or
manufacturing revenue. AstraZeneca AB and UCB Pharma represented 35% and 17%,
respectively, of our total revenue during the year ended December 31,
2009. No other collaboration partner accounted for more than 10% of
our total revenue during the year ended December 31, 2009. If we are unable to
continue to develop and protect proprietary intellectual property and license
our technologies to partners, our business, results of operations and financial
condition could suffer.
20
Backlog
In our
partnered programs where we manufacture and supply our proprietary drug
formulations, inventory is produced and sales are made pursuant to customer
purchase orders for delivery. The volume of drug formulation actually purchased
by our customers, as well as shipment schedules, are subject to frequent
revisions that reflect changes in both the customers’ needs and product
availability. In our partnered programs where we provide contract research
services, those services are typically provided under a work plan that is
subject to frequent revisions that change based on the development needs and
status of the program. The backlog at a particular time is affected by a number
of factors, including scheduled date of manufacture and delivery and development
program status. In light of industry practice and our own experience, we do not
believe that backlog as of any particular date is indicative of future
results.
Competition
Competition
in the pharmaceutical and biotechnology industry is intense and characterized by
aggressive research and development and rapidly-evolving science, technology,
and standards of medical care throughout the world. We frequently compete with
pharmaceutical companies and other institutions with greater financial, research
and development, marketing and sales, manufacturing and managerial capabilities.
We face competition from these companies not just in product development but
also in areas such as recruiting employees, acquiring technologies that might
enhance our ability to commercialize products, establishing relationships with
certain research and academic institutions, enrolling patients in clinical
trials and seeking program partnerships and collaborations with larger
pharmaceutical companies.
Science
and Technology Competition
We
believe that our proprietary and partnered products will compete with others in
the market on the basis of one or more of the following parameters: efficacy,
safety, ease of use and cost. We face intense science and technology competition
from a multitude of technologies seeking to enhance the efficacy, safety and
ease of use of approved drugs and new drug molecule candidates. A number of the
products in our pipeline have direct and indirect competition from large
pharmaceutical companies and biopharmaceutical companies. With our PEGylation
and advanced polymer conjugate technologies, we believe we have competitive
advantages relating to factors such as efficacy, safety, ease of use and cost
for certain applications and molecules. We constantly monitor scientific and
medical developments in order to improve our current technologies, seek
licensing opportunities where appropriate, and determine the best applications
for our technology platforms.
In the
fields of PEGylation and advanced polymer conjugate technologies, our
competitors include The Dow Chemical Company, Enzon Pharmaceuticals, Inc.,
SunBio Corporation, Novo Nordisk A/S (formerly assets held by Neose
Technologies, Inc.), Mountain View Pharmaceuticals, Inc., and NOF Corporation.
Several other chemical, biotechnology and pharmaceutical companies may also be
developing PEGylation technology, advanced polymer conjugate technology or
technologies intended to deliver similar scientific and medical benefits. Some
of these companies license or provide the technology to other companies, while
others develop the technology for internal use.
Product
and Program Specific Competition
Oral
NKTR-118 (oral PEGylated naloxol)
There are
no oral drugs approved specifically for the treatment of opioid-induced
constipation (OIC) or opioid bowel dysfunction (OBD). The only approved
treatment for OIC is a subcutaneous treatment known as methylnaltrexone bromide
marketed by Pfizer (formerly Wyeth). Other current therapies that are utilized
to treat OIC and OBD include over-the-counter laxatives and stool softeners,
such as docusate sodium, senna, and milk of magnesia. These therapies do not
address the underlying cause of constipation as a result of opioid use and are
generally viewed as ineffective or only partially effective to treat the
symptoms of OID and OBD.
There are
a number of companies developing potential products which are in various stages
of clinical development and are being evaluated for the treatment of OIC and OBD
in different patient populations. Potential competitors include Progenics
Pharmaceuticals, Inc., Pfizer (formerly Wyeth), Adolor Corporation,
GlaxoSmithKline, Mundipharma Int. Limited, Sucampo Pharmaceuticals, Alkermes and
Takeda Pharmaceutical Company Limited.
NKTR-102
(PEGylated irinotecan)
There are
a number of chemotherapies and cancer therapies approved today and in various
stages of clinical development for ovarian and breast cancers including but not
limited to: Avastin®
(bevacizumab), Camptosar®
(irinotecan), Ellence®
(epirubicin), Gemzar®
(gemcitabine), Herceptin®
(trastuzumab), Hycamtin®
(topotecan), Paraplatin®
(carboplatin), and Taxol®
(paclitaxel). These therapies are only partially effective in treating ovarian,
breast or cervical cancers. Major pharmaceutical or biotechnology
companies with approved drugs or drugs in development for these cancers include
Bristol-Meyers Squibb, Genentech, Inc., GlaxoSmithKline plc, Pfizer, Inc., Eli
Lilly & Co., and many others.
21
There are
also a number of chemotherapies and cancer therapies approved today and in
clinical development for the treatment of colorectal cancer. Approved therapies
for the treatment of colorectal cancer include Eloxatin, Camptosar, Avastin,
Erbitux, Vectibix, Xeloda, Adrucil, and Wellcovorin. These therapies are only
partially effective in treating the disease. There are a number of drugs in
various stages of preclinical and clinical development from companies exploring
cancer therapies or improved chemotherapeutic agents to potentially treat
colorectal cancer. If these drugs are approved, they could be competitive with
NKTR-102. These include products in development from Bristol-Myers Squibb
Company, Pfizer, Inc., GlaxoSmithKline plc, Antigenics, Inc., F. Hoffman-La
Roche Ltd, Novartis AG, Cell Therapeutics, Inc., Neopharm Inc., Meditech
Research Ltd, Alchemia Limited, Enzon Pharmaceuticals, Inc., and
others.
BAY41-6551
(NKTR-061, Amikacin
Inhale)
There are
currently no approved drugs on the market for adjunctive treatment or prevention
of Gram-negative pneumonias in mechanically ventilated patients which are also
administered via the pulmonary route. The current standard of care includes
approved intravenous antibiotics which are partially effective for the treatment
of either hospital-acquired pneumonia or ventilator-associated pneumonia in
patients on mechanical ventilators. These drugs include drugs that fall into the
categories of antipseudomonal cephalosporins, antipseudomonal carbepenems,
beta-lactam/beta-lactamase inhibitors, antipseudomonal fluoroquinolones, such as
ciprofloxacin or levofloxacin, and aminoglycosides, such as amikacin, gentamycin
or tobramycin.
Environment
As a
manufacturer of drug products for the U.S. market, we are subject to inspections
by the FDA for compliance with cGMP and other U.S. regulatory requirements,
including U.S. federal, state and local regulations regarding environmental
protection and hazardous and controlled substance controls, among others.
Environmental laws and regulations are complex, change frequently and have
tended to become more stringent over time. We have incurred, and may continue to
incur, significant expenditures to ensure we are in compliance with these laws
and regulations. We would be subject to significant penalties for failure to
comply with these laws and regulations.
Employees
and Consultants
As of
December 31, 2009, we had 335 employees, of which 239 employees were engaged in
research and development, commercial operations and quality activities and 96
employees were engaged in general administration and business development. Of
the 335 employees, 279 were located in the United States and 56 were located in
India as of December 31, 2009. We have a number of employees who hold advanced
degrees, such as Ph.D.s. None of our employees are covered by a collective
bargaining agreement, and we have experienced no work stoppages. We believe that
we maintain good relations with our employees.
To
complement our own expert professional staff, we utilize specialists in
regulatory affairs, process engineering, manufacturing, quality assurance,
clinical development and business development. These individuals include certain
of our scientific advisors as well as independent consultants.
Available
Information
Our
website address is http://www.nektar.com. The
information in, or that can be accessed through, our website is not part of this
annual report on Form 10-K. Our annual reports on Form 10-K, quarterly reports
on Form 10-Q and current reports on Form 8-K and amendments to those reports are
available, free of charge, on or through our website as soon as reasonably
practicable after we electronically file such material with, or furnish it to,
the Securities Exchange Commission (SEC). The public may read and copy any
materials we file with the SEC at the SEC’s Public Reference Room at 100 F
Street, NE, Washington, D.C. 20549. Information on the operation of the Public
Reference Room can be obtained by calling 1-800-SEC-0330. The SEC maintains an
Internet site that contains reports, proxy and information statements and other
information regarding our filings at www.sec.gov.
22
EXECUTIVE
OFFICERS OF THE REGISTRANT
The
following table sets forth the names, ages and positions of our executive
officers as of February 28, 2010:
Name
|
Age
|
Position
|
||
Howard
W. Robin
|
57
|
Director,
President and Chief Executive Officer
|
||
John
Nicholson
|
58
|
Senior
Vice President and Chief Financial Officer
|
||
Bharatt
M. Chowrira, Ph.D., J.D.
|
44
|
Senior
Vice President and Chief Operating Officer
|
||
Lorianne
K. Masuoka, M.D.
|
48
|
Senior
Vice President and Chief Medical Officer
|
||
Stephen
K. Doberstein, Ph.D.
|
51
|
Senior
Vice President and Chief Scientific Officer
|
||
Gil
M. Labrucherie, J.D.
|
38
|
Senior
Vice President, General Counsel and Secretary
|
||
Jillian
B. Thomsen
|
|
44
|
|
Senior
Vice President and Chief Accounting
Officer
|
Howard W. Robin has served as
our Director, President and Chief Executive Officer since January 2007 and was
appointed as a member of our Board of Directors in February 2007. Mr. Robin
served as Chief Executive Officer, President and director of Sirna Therapeutics,
Inc., a clinical-stage biotechnology company pioneering RNAi-based therapies for
serious diseases and conditions, from July 2001 to November 2006 and served as
their Chief Operating Officer, President and Director from January 2001 to June
2001. From 1991 to 2001, Mr. Robin was Corporate Vice President and General
Manager at Berlex Laboratories, Inc., the U.S. pharmaceutical subsidiary of the
German pharmaceutical firm Schering AG, and, from 1987 to 1991, he served as
their Vice President of Finance and Business Development and Chief Financial
Officer. From 1984 to 1987, Mr. Robin was Director of Business Planning and
Development at Berlex and was a Senior Associate with Arthur Andersen LLP prior
to joining Berlex. Since February 2006, Mr. Robin has served as a member of the
Board of Directors of Acologix, Inc., a biopharmaceutical company focused on
therapeutic compounds for the treatment of osteo-renal diseases. He received his
B.S. in Accounting and Finance from Fairleigh Dickinson University in
1974.
John Nicholson has served as
our Senior Vice President and Chief Financial Officer since December 2007. Mr.
Nicholson joined the Company as Senior Vice President of Corporate Development
and Business Operations in October 2007 and was appointed Senior Vice President
and Chief Financial Officer in December 2007. Before joining Nektar, Mr.
Nicholson spent 18 years in various executive roles at Schering Berlin, Inc.,
the U.S. management holding company of Bayer Schering Pharma AG, a
pharmaceutical company. From 1997 to September 2007, Mr. Nicholson served as
Schering Berlin Inc.’s Vice President of Corporate Development and
Treasurer. From 2001 to September 2007, he concurrently served as
President of Schering Berlin Insurance Co., and from February 2007 through
September 2007, he also concurrently served as President of Bayer Pharma
Chemicals and Schering Berlin Capital Corp. Mr. Nicholson holds a
B.B.A. from the University of Toledo.
Bharatt M. Chowrira, Ph.D., J.D.
has served as our Senior Vice President and Chief Operating Officer since
May 2008, as well as Chairman of Nektar Therapeutics India Pvt. Ltd. From
January 2007 until May 2008, Dr. Chowrira, served as Executive Director,
Licensing / External Research at Merck & Co., Inc., a global pharmaceutical
company. From January 2005 through 2006, Dr. Chowrira served as Chief Patent
Counsel and Vice President, Legal Affairs of Sirna Therapeutics, Inc., a
clinical-stage biotechnology company pioneering RNAi-based therapies for serious
diseases and conditions that was acquired by Merck & Co. in January 2007. In
that position, Dr. Chowrira was responsible for all legal and business licensing
activities and general corporate matters. From January 2002 until December 2004,
Dr. Chowrira was Vice President of Legal Affairs, Licensing and Patent Counsel
at Sirna Therapeutics. Dr. Chowrira joined Sirna Therapeutics (then operating as
Ribozyme Pharmaceuticals Inc.) in 1993 as a scientist. Dr. Chowrira holds a J.D.
from the College of Law at the University of Denver and a Ph.D. in Microbiology
and Molecular Genetics from the University of Vermont. Dr. Chowrira is a member
of the Colorado Bar Association, admitted to practice in California as a
registered in-house counsel, and is a registered patent attorney before the U.S.
Patent and Trademark Office. He is also a member of the American Intellectual
Property Law Association, Licensing Executive Society and the Association of
Corporate Counsel.
Lorianne K. Masuoka, M.D. has
served as our Senior Vice President and Chief Medical Officer since November 30,
2009, and prior to that served as our Vice President of Clinical Development
from August 2008 to June 2009. From 2003 until August 2008, Dr.
Masuoka served as Vice President of Clinical Development at privately held Five
Prime Therapeutics, a clinical stage biotechnology company. From 2000
until 2003, she was Director of Oncology at Chiron Corporation, a multi-national
biotechnology firm, acquired by Novartis International AG in April 2006.
From 1994 until 2000, Dr. Masuoka held positions of increasing responsibility in
clinical research at Berlex Laboratories, Inc., the U.S. pharmaceutical
subsidiary of the German pharmaceutical firm Schering AG. Dr. Masuoka
received her B.S. and M.D. from the University of California, Davis, was an
American Epilepsy Society Fellow at Yale School of Medicine and is board
certified in Neurology.
23
Stephen K. Doberstein, Ph.D.
has served as our Senior Vice President and Chief Scientific Officer
since January 2010. From October 2008 through December 2009,
Mr. Doberstein served as Vice President, Research at Xoma (US) LLC, a publicly
traded clinical stage biotechnology company. From July 2004 until
August 2008, he served as Vice President, Research at privately held Five Prime
Therapeutics, a clinical stage biotechnology company. From September
2001 until July 2004, Mr. Doberstein was Vice President, Research at privately
held Xencor, Inc., a clinical stage biotechnology company. From
1997 to 2000, he held various pharmaceutical research positions at Exelixis,
Inc., a publicly traded clinical stage biotechnology company. Prior
to working at Exelixis, Mr. Doberstein was a Howard Hughes Postdoctoral Fellow
and a Muscular Dystrophy Association Senior Postdoctoral Fellow at the
University of California Berkeley. Mr. Doberstein received his Ph.D.
Biochemistry, Cell and Molecular Biology from the Johns Hopkins University
School of Medicine and received a B.S. in Chemical Engineering from the
University of Delaware.
Gil M. Labrucherie has served
as our Senior Vice President, General Counsel and Secretary since April 2007,
responsible for all aspects of our legal affairs. Mr. Labrucherie served as our
Vice President, Corporate Legal from October 2005 through April 2007. From
October 2000 to September 2005, Mr. Labrucherie was Vice President of Corporate
Development at E2open. While at E2open, Mr. Labrucherie was responsible for
global corporate alliances and merger and acquisition activity. Prior to E2open,
he was the Senior Director of Corporate Development at AltaVista Company, an
Internet search company, where he was responsible for strategic partnerships and
mergers and acquisitions. Mr. Labrucherie began his career as an associate in
the corporate practice of the law firm of Wilson Sonsini Goodrich & Rosati
and Graham & James (DLA Piper Rudnick). Mr. Labrucherie received his J.D.
from the Berkeley Law School and a B.A. from the University of California
Davis.
Jillian B. Thomsen has served
as our Senior Vice President Finance and Chief Accounting Officer since February
2010. From March 2006 through March 2008, Ms. Thomsen served as our Vice
President Finance and Corporate Controller and from April 2008 through January
2010 she served as our Vice President Finance and Chief Accounting
Officer. Before joining Nektar, Ms. Thomsen was Vice President
Finance and Deputy Corporate Controller of Calpine Corporation from September
2002 to February 2006. Ms. Thomsen is a certified public accountant
and previously was a senior manager at Arthur Andersen LLP, where she worked
from 1990 to 2002, and specialized in audits of multinational consumer products,
life sciences, manufacturing and energy companies. Ms. Thomsen holds a Masters
of Accountancy from the University of Denver and a B.A. in Business Economics
from Colorado College.
Item 1A. Risk
Factors
We are
providing the following cautionary discussion of risk factors, uncertainties and
possibly inaccurate assumptions that we believe are relevant to our business.
These are factors that, individually or in the aggregate, we think could cause
our actual results to differ materially from expected and historical results and
our forward-looking statements. We note these factors for investors as permitted
by Section 21E of the Exchange Act and Section 27A of the Securities Act. You
should understand that it is not possible to predict or identify all such
factors. Consequently, you should not consider this section to be a complete
discussion of all potential risks or uncertainties that may substantially impact
our business.
Risks
Related to Our Business
Drug development is an inherently
uncertain process and there is a high risk of failure at every stage of development
and development failures can significantly harm our
business.
We have a
number of proprietary product candidates and partnered product candidates in
research and development ranging from the early discovery research phase through
preclinical testing and clinical trials. Preclinical testing and clinical trials
are long, expensive and a highly uncertain processes. It will take us, or our
collaborative partners, several years to complete clinical trials. Drug
development is an uncertain scientific and medical endeavor and failure can
unexpectedly occur at any stage of clinical development even after early
preclinical or mid-stage clinical results suggest that the drug candidate has
potential as a new therapy that may benefit patients and health authority
approval would be anticipated. Typically, there is a high rate of attrition for
product candidates in preclinical and clinical trials due to scientific
feasibility, safety, efficacy, changing standards of medical care and other
variables. We or our partners have a number of important product
candidates in mid- to late-stage development such as Bayer’s Amikacin Inhale,
Oral NKTR-118 (oral PEGylated naloxol) and NKTR-119 which we partnered with
AstraZeneca, Affymax’s Hematide, and NKTR-102 (PEGylated irinotecan) in a number
of oncology indications including breast, colorectal and ovarian
cancers. We also have an ongoing Phase 1 clinical trial for NKTR-105
(PEGylated docetaxel) for patients with refractory solid tumors. Any
one of these trials could fail at any time as clinical development of drug
candidates presents numerous unpredictable risks and is very uncertain at all
times prior to regulatory approval by one or more health authorities in major
markets.
24
Even with success in preclinical
testing and clinical trials, the risk of clinical failure remains high prior
to regulatory approval.
A number
of companies in the pharmaceutical and biotechnology industries have suffered
significant unforeseen setbacks in later stage clinical trials (i.e., Phase 2 or
Phase 3 trials) due to factors such as inconclusive efficacy results and adverse
medical events, even after achieving positive results in earlier trials that
were satisfactory both to them and to reviewing regulatory agencies. Although we
announced positive Phase 2 clinical results for Oral NKTR-118 (oral PEGylated
naloxol) in 2009, there are still substantial risks and uncertainties associated
with the future outcome of a Phase 3 clinical trial and the regulatory review
process even following the AstraZeneca transaction. While NKTR-102
(PEGylated irinotecan) continues in Phase 2 clinical development for multiple
cancer indications, it is possible this product candidate could fail in one or
all of the cancer indications in which it is currently being studied due to
efficacy, safety or other commercial or regulatory factors. On
January 12, 2010, we announced preliminary positive results from stage one of
our Phase 2 trial for ovarian cancer patients. These results were
based on preliminary data only and such results could change based on final data
gathering and analysis review procedures. In addition, the
preliminary results from stage 1 of the NKTR-102 clinical study for ovarian
cancer is not necessarily indicative or predictive of the future results from
stage 2 of this clinical study or the other cancer indication where we are
studying NKTR-102. As a result, there remains a significant
uncertainty as to the success or failure of NKTR-102 and whether this drug
candidate will eventually receive regulatory approval or be a commercial success
even if approved by one or more health authorities in any of the cancer
indications for which it is being studied. The risk of failure is
increased for our product candidates that are based on new technologies, such as
the application of our advanced polymer conjugate technology to small molecules,
including without limitation Oral NKTR-118, Oral NKTR-119, NKTR-102, NKTR-105
and other drug candidates currently in the discovery research or preclinical
development phases. If our PEGylation and advanced polymer conjugate
technologies fail to generate new drug candidates with positive clinical trial
results and approved drugs, our business, results of operations, and financial
condition would be materially harmed.
If we are unable to establish and
maintain collaboration partnerships on attractive commercial terms, our
business, results of operations and financial condition could
suffer.
We intend
to continue to seek partnerships with pharmaceutical and biotechnology partners
to fund a portion of our research and development expenses and develop and
commercialize our product candidates, including NKTR-102. In September 2009, we
entered into a license agreement with AstraZeneca for NKTR-118 and NKTR-119
which included an upfront payment of $125.0 million. The completion
of the AstraZeneca transaction was critical to our financial results and
financial condition for the year ended December 31, 2009. We intend
to seek a collaboration partner for NKTR-102 prior to commencing any Phase 3
clinical trials for this drug candidate. Whether we ultimately enter into
a collaboration agreement for NKTR-102 will depend on the partnership
opportunities available to us. Our ability to successfully conclude a
collaboration partnership for NKTR-102 on commercially favorable terms, or at
all, will have a significant impact on our business and financial position in
2010. The timing of any future partnership, as well as the terms and conditions
of the partnership, will affect our ability to benefit from the relationship. If
we are unable to find suitable partners or to negotiate collaborative
arrangements with favorable commercial terms with respect to our existing and
future product candidates or the licensing of our technology, or if any
arrangements we negotiate, or have negotiated, are terminated, our business,
results of operations and financial condition could suffer.
We may not be able to obtain
intellectual property licenses related to the development of our technology on a
commercially reasonable basis, if at all.
Numerous
pending and issued U.S. and foreign patent rights and other proprietary rights
owned by third parties relate to pharmaceutical compositions, medical devices
and equipment and methods for preparation, packaging and delivery of
pharmaceutical compositions. We cannot predict with any certainty which, if any,
patent references will be considered relevant to our or our collaborative
partners’ technology by authorities in the various jurisdictions where such
rights exist, nor can we predict with certainty which, if any, of these rights
will or may be asserted against us by third parties. In certain
cases, we have existing licenses or cross-licenses with third parties however
the scope and adequacy of these licenses is very uncertain and can change
substantially during long development and commercialization cycles for
biotechnology and pharmaceutical products. There can be no assurance
that we can obtain a license to any technology that we determine we need on
reasonable terms, if at all, or that we could develop or otherwise obtain
alternate technology. If we are required to enter into a license with a third
party, our potential economic benefit for the products subject to the license
will be diminished. The failure to obtain licenses on commercially reasonable
terms, or at all, if needed, would have a material adverse effect on
us.
25
If any of our pending patent
applications do not issue, or are deemed invalid following issuance, we may lose
valuable intellectual property protection.
The
patent positions of pharmaceutical, medical device and biotechnology companies,
such as ours, are uncertain and involve complex legal and factual issues. We own
approximately 100 U.S. and approximately 380 foreign patents and a number of
pending patent applications that cover various aspects of our technologies. We
have filed patent applications, and plan to file additional patent applications,
covering various aspects of our PEGylation and advanced polymer conjugate
technologies and our proprietary product candidates. There can be no assurance
that patents that have issued will be valid and enforceable or that patents for
which we apply will issue with broad coverage, if at all. The coverage claimed
in a patent application can be significantly reduced before the patent is issued
and, as a consequence, our patent applications may result in patents with narrow
coverage. Since publication of discoveries in scientific or patent literature
often lags behind the date of such discoveries, we cannot be certain that we
were the first inventor of inventions covered by our patents or patent
applications. As part of the patent application process, we may have to
participate in interference proceedings declared by the U.S. Patent and
Trademark Office, which could result in substantial cost to us, even if the
eventual outcome is favorable. Further, an issued patent may undergo further
proceedings to limit its scope so as not to provide meaningful protection and
any claims that have issued, or that eventually issue, may be circumvented or
otherwise invalidated. Any attempt to enforce our patents or patent application
rights could be time consuming and costly. An adverse outcome could subject us
to significant liabilities to third parties, require disputed rights to be
licensed from or to third parties or require us to cease using the technology in
dispute. Even if a patent is issued and enforceable, because development and
commercialization of pharmaceutical products can be subject to substantial
delays, patents may expire early and provide only a short period of protection,
if any, following commercialization of related products.
There are
many laws, regulations and judicial decisions that dictate and otherwise
influence the manner in which patent applications are filed and prosecuted and
in which patents are granted and enforced. Changes to these laws, regulations
and judicial decisions are subject to influences outside of our control and may
negatively affect our business, including our ability to obtain meaningful
patent coverage or enforcement rights to any of our issued patents. New laws,
regulations and judicial decisions may be retroactive in effect, potentially
reducing or eliminating our ability to implement our patent-related strategies
to these changes. Changes to laws, regulations and judicial decisions that
affect our business are often difficult or impossible to foresee, which limits
our ability to adequately adapt our patent strategies to these
changes.
The commercial potential of a drug
candidate in development is difficult to predict and if the market size for a
new drug is significantly smaller than we anticipated, it could significantly
and negatively impact our revenue, results of operations and financial
condition.
It is
very difficult to estimate the commercial potential of product candidates due to
factors such as safety and efficacy compared to other available treatments,
including potential generic drug alternatives with similar efficacy profiles,
changing standards of care, third party payer reimbursement, patient and
physician preferences, the availability of competitive alternatives that may
emerge either during the long drug development process or after commercial
introduction, and the availability of generic versions of our successful product
candidates following approval by health authorities based on the expiration of
regulatory exclusivity or our inability to prevent generic versions from
coming to market in one or more geographies by the assertion of one or more
patents covering such approved drug. If due to one or more of these
risks the market potential for a product candidate is lower than we anticipated,
it could significantly and negatively impact the commercial terms of any
collaboration partnership potential for such product candidate or, if we have
already entered into a collaboration for such drug candidate, the revenue
potential from royalty and milestones could be significantly diminished and
would negatively impact our revenue, results of operations and financial
condition.
Our revenue is exclusively derived
from our collaboration agreements, which can result in significant fluctuation in
our revenue from period to period, and our past revenue is therefore not
necessarily indicative of our future revenue.
Our
revenue is derived from our collaboration agreements with partners, under which
we may receive contract research payments, milestone payments based on clinical
progress, regulatory progress or net sales achievements, royalties or
manufacturing revenue. Significant variations in the timing of receipt of cash
payments and our recognition of revenue can result from the nature of
significant milestone payments based on the execution of new collaboration
agreements, the timing of clinical, regulatory or sales events which result in
single milestone payments and the timing and success of the commercial launch of
new drugs by our collaboration partners. The amount of our revenue derived from
collaboration agreements in any given period will depend on a number of
unpredictable factors, including our ability to find and maintain suitable
collaboration partners, the timing of the negotiation and conclusion of
collaboration agreements with such partners, whether and when we or our partner
achieve clinical and sales milestones, whether the partnership is exclusive or
whether we can seek other partners, the timing of regulatory approvals in one or
more major markets and the market introduction of new drugs or generic versions
of the approved drug, as well as other factors.
26
If our partners, on which we depend
to obtain regulatory approvals for and to commercialize our partnered products,
are not successful, or if such collaborations fail, the development
or commercialization of our partnered products may be delayed or
unsuccessful.
When we
sign a collaborative development agreement or license agreement to develop a
product candidate with a pharmaceutical or biotechnology company, the
pharmaceutical or biotechnology company is generally expected to:
•
|
design
and conduct large scale clinical
studies;
|
•
|
prepare
and file documents necessary to obtain government approvals to sell a
given product candidate; and/or
|
•
|
market
and sell our products when and if they are
approved.
|
Our
reliance on collaboration partners poses a number of risks to our business,
including risks that:
•
|
we
may be unable to control whether, and the extent to which, our partners
devote sufficient resources to the development programs or commercial
marketing and sales efforts;
|
•
|
disputes
may arise in the future with respect to the ownership of rights to
technology or intellectual property developed with
partners;
|
•
|
disagreements
with partners could lead to delays in, or termination of, the research,
development or commercialization of product candidates or to litigation or
arbitration proceedings;
|
•
|
contracts
with our partners may fail to provide us with significant protection, or
to be effectively enforced, in the event one of our partners fails to
perform;
|
•
|
partners
have considerable discretion in electing whether to pursue the development
of any additional product candidates and may pursue alternative
technologies or products either on their own or in collaboration with our
competitors;
|
•
|
partners
with marketing rights may choose to devote fewer resources to the
marketing of our partnered products than they do to products of their own
development or products in-licensed from other third
parties;
|
•
|
the
timing and level of resources that our partners dedicate to the
development program will affect the timing and amount of revenue we
receive;
|
•
|
we
do not have the ability to unilaterally terminate agreements (or partner
companies may have extension or renewal rights) that we believe are not on
commercially reasonable terms or consistent with our current business
strategy;
|
|
•
|
partners
may be unable to pay us as expected;
and
|
•
|
partners
may terminate their agreements with us unilaterally for any or no reason,
in some cases with the payment of a termination fee penalty and in other
cases with no termination fee
penalty.
|
Given
these risks, the success of our current and future partnerships is highly
unpredictable and can have substantial negative or positive impact on our
business. We have entered into collaborations in the past that have been
subsequently terminated, such as our collaboration with Pfizer for the
development and commercialization of inhaled insulin that was terminated by
Pfizer in November 2007. If other collaborations are suspended or terminated,
our ability to commercialize certain other proposed product candidates could
also be negatively impacted. If our collaborations fail, our product development
or commercialization of product candidates could be delayed or cancelled, which
would negatively impact our business, results of operations and financial
condition.
27
If we or our partners do not obtain
regulatory approval for our product candidates on a timely basis, if at
all, or if the terms of any approval impose significant restrictions or
limitations on use, our business, results of operations and financial condition
will be negatively affected.
We or our
partners may not obtain regulatory approval for product candidates on a timely
basis, if at all, or the terms of any approval (which in some countries includes
pricing approval) may impose significant restrictions or limitations on use.
Product candidates must undergo rigorous animal and human testing and an
extensive FDA mandated or equivalent foreign authorities’ review process for
safety and efficacy. This process generally takes a number of years and requires
the expenditure of substantial resources. The time required for completing
testing and obtaining approvals is uncertain, and the FDA and other U.S. and
foreign regulatory agencies have substantial discretion to terminate clinical
trials, require additional clinical development or other testing at any phase of
development, delay or withhold registration and marketing approval and mandate
product withdrawals, including recalls. In addition, undesirable side effects
caused by our product candidates could cause us or regulatory authorities to
interrupt, delay or halt clinical trials and could result in a more restricted
label or the delay or denial of regulatory approval by regulatory
authorities.
Even if
we or our partners receive regulatory approval of a product, the approval may
limit the indicated uses for which the product may be marketed. Our partnered
products that have obtained regulatory approval, and the manufacturing processes
for these products, are subject to continued review and periodic inspections by
the FDA and other regulatory authorities. Discovery from such review and
inspection of previously unknown problems may result in restrictions on marketed
products or on us, including withdrawal or recall of such products from the
market, suspension of related manufacturing operations or a more restricted
label. The failure to obtain timely regulatory approval of product candidates,
any product marketing limitations or a product withdrawal would negatively
impact our business, results of operations and financial condition.
We are a party to numerous
collaboration agreements and other significant agreements which contain complex commercial
terms that could result in disputes, litigation or indemnification
liability that could adversely affect our business, results of operations and
financial condition.
We
currently derive, and expect to derive in the foreseeable future, all of our
revenue from collaboration agreements with biotechnology and pharmaceutical
companies. These collaboration agreements contain complex commercial terms,
including:
•
|
clinical
development and commercialization obligations that are based on certain
commercial reasonableness performance standards that can often be
difficult to enforce if disputes arise as to adequacy of
performance;
|
•
|
research
and development performance and reimbursement obligations for our
personnel and other resources allocated to partnered product development
programs;
|
•
|
clinical
and commercial manufacturing agreements, some of which are priced on an
actual cost basis for products supplied by us to our partners with
complicated cost allocation formulas and
methodologies;
|
•
|
intellectual
property ownership allocation between us and our partners for improvements
and new inventions developed during the course of the
partnership;
|
•
|
royalties
on end product sales based on a number of complex variables, including net
sales calculations, geography, patent life, generic competitors, and other
factors; and
|
•
|
indemnity
obligations for third-party intellectual property infringement, product
liability and certain other claims.
|
On
September 20, 2009, we entered into a worldwide exclusive license agreement with
AstraZeneca for the further development and commercialization of NKTR-118 and
NKTR-119. In addition, we have also entered into complex commercial
agreements with Novartis in connection with the sale of certain assets related
to our pulmonary business, associated technology and intellectual property to
Novartis (Novartis Pulmonary Asset Sale), which was completed on December 31,
2008. Our agreements with AstraZeneca and Novartis contain complex
representations and warranties, covenants and indemnification obligations that
could result in substantial future liability and harm our financial condition if
we breach any of our agreements with AstraZeneca or Novartis or any third party
agreements impacted by this complex transaction. As part of the Pulmonary Asset
Sale, we entered an exclusive license agreement with Novartis Pharma pursuant to
which Novartis Pharma grants back to us an exclusive, irrevocable, perpetual,
royalty-free and worldwide license under certain specific patent rights and
other related intellectual property rights necessary for us to satisfy certain
continuing contractual obligations to third parties, including in connection
with development, manufacture, sale and commercialization activities related to
our partnered program for BAY41-6551 with Bayer Healthcare LLC . We also entered
into a service agreement pursuant to which we have subcontracted to Novartis
certain services to be performed related to our partnered program for BAY41-6551
and a transition services agreement pursuant to which Novartis and we will
provide each other with specified services for limited time periods following
the closing of the Novartis Pulmonary Asset Sale to facilitate the transition of
the acquired assets and business from us to Novartis.
28
From time
to time, we have informal dispute resolution discussions with third parties
regarding the appropriate interpretation of the complex commercial terms
contained in our agreements. One or more disputes may arise in the future
regarding our collaboration agreements, transaction documents, or third party
license agreements that may ultimately result in costly litigation and
unfavorable interpretation of contract terms, which would have a material
adverse impact on our business, results of operations or financial
condition.
If we or our partners are not able to
manufacture drugs in quantities and at costs that are commercially feasible,
our proprietary and partnered product candidates may experience clinical
delays or constrained commercial supply which could significantly harm our
business.
If we are
not able to scale-up manufacturing to meet the drug quantities required to
support large clinical trials or commercial manufacturing in a timely manner or
at a commercially reasonable cost, we risk delaying our clinical trials or those
of our partners, may breach contractual obligations and incur associated damages
and costs, and reduce or even eliminate associated revenues. In some
cases, we may subcontract manufacturing or other services. For instance, we
entered a service agreement with Novartis pursuant to which we subcontract to
Novartis certain important services to be performed in relation to our partnered
program for BAY41-6551 with Bayer Healthcare LLC. If our subcontractors do not
dedicate adequate resources to our programs, we risk breach of our obligations
to our partners. Building and validating large scale clinical or
commercial-scale manufacturing facilities and processes, recruiting and training
qualified personnel and obtaining necessary regulatory approvals is complex,
expensive and time consuming. In the past we have encountered challenges in
scaling up manufacturing to meet the requirements of large scale clinical trials
without making modifications to the drug formulation, which may cause
significant delays in clinical development. Further, our drug and device
combination products, such as BAY41-6551 and the Cipro Inhale program, require
significant device design, formulation development work and manufacturing
scale-up activities. Further, we have experienced delays in starting
the Phase 3 clinical development program for BAY41-6551 as we work to finalize
the device design with a demonstrated capability to be manufactured at
commercial scale. This work is ongoing. Drug/device combination
products are particularly complex, expensive, time-consuming and uncertain due
to the number of variables involved in the final product design, including ease
of patient/doctor use, maintenance of clinical efficacy, reliability and cost of
manufacturing, regulatory approval requirements and standards and other
important factors. Failure to manufacture products in quantities or at costs
that are commercially feasible could cause us not to meet our supply
requirements, contractual obligations or other requirements for our proprietary
product candidates and, as a result, would significantly harm our business,
results of operations and financial condition.
We purchase some of the starting
material for drugs and drug candidates from a single source or a limited
number of suppliers, and the partial or complete loss of one of these
suppliers could cause production delays, clinical trial delays, substantial loss of
revenue and contract liability to third parties.
We often
face very limited supply of a critical raw material that can only be obtained
from a single, or a limited number of, suppliers, which could cause production
delays, clinical trial delays, substantial lost revenue opportunity or contract
liability to third parties. For example, there are only a limited number of
qualified suppliers, and in some cases single source suppliers, for the raw
materials included in our PEGylation and advanced polymer conjugate drug
formulations, and any interruption in supply or failure to procure such raw
materials on commercially feasible terms could harm our business by delaying our
clinical trials, impeding commercialization of approved drugs or increasing
operating loss to the extent we cannot pass on increased costs to a
manufacturing customer.
We rely on trade secret protection
and other unpatented proprietary rights for important proprietary technologies,
and any loss of such rights could harm our business, results of operations and
financial condition.
We rely
on trade secret protection for our confidential and proprietary information. No
assurance can be given that others will not independently develop substantially
equivalent confidential and proprietary information or otherwise gain access to
our trade secrets or disclose such technology, or that we can meaningfully
protect our trade secrets. In addition, unpatented proprietary rights, including
trade secrets and know-how, can be difficult to protect and may lose their value
if they are independently developed by a third party or if their secrecy is
lost. Any loss of trade secret protection or other unpatented proprietary rights
could harm our business, results of operations and financial
condition.
29
We expect to continue to incur
substantial losses and negative cash flow from operations and may not achieve or
sustain profitability in the future.
For the
year ended December 31, 2009, we reported a net loss of $102.5
million. If and when we achieve profitability depends upon a number
of factors, including the timing and recognition of milestone payments and
royalties received, the timing of revenue under our collaboration agreements,
the amount of investments we make in our proprietary product candidates and the
regulatory approval and market success of our product candidates. We may not be
able to achieve and sustain profitability.
Other
factors that will affect whether we achieve and sustain profitability include
our ability, alone or together with our partners, to:
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develop products utilizing our
technologies, either independently or in collaboration with other
pharmaceutical or biotech
companies;
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receive necessary regulatory and
marketing approvals;
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maintain or expand manufacturing
at necessary levels;
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achieve market acceptance of our
partnered products;
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receive royalties on products
that have been approved, marketed or submitted for marketing approval with
regulatory authorities; and
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maintain sufficient funds to
finance our activities.
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If we do not generate sufficient cash
flow through increased revenue or raising additional capital, we may not be
able to meet our substantial debt obligations.
As of
December 31, 2009, we had cash, cash equivalents, and short-term investments in
marketable securities valued at approximately $396.2 million and approximately
$240.7 million of indebtedness, including approximately $215.0 million in
convertible subordinated notes due September 2012, $20.3 million in capital
lease obligations, and $5.4 million of other long-term liabilities.
Our
substantial indebtedness has and will continue to impact us by:
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making it more difficult to
obtain additional financing;
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constraining our ability to react
quickly in an unfavorable economic
climate;
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constraining our stock price;
and
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constraining our ability to
invest in our proprietary product development
programs.
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Currently,
we are not generating positive cash flow. If we are unable to satisfy our debt
service requirements, substantial liquidity problems could result. In relation
to our convertible subordinated notes, since the market price of our common
stock is significantly below the conversion price, the holders of our
outstanding convertible subordinated notes are unlikely to convert the notes to
common stock in accordance with the existing terms of the notes. If we do not
generate sufficient cash from operations to repay principal or interest on our
remaining convertible subordinated notes, or satisfy any of our other debt
obligations, when due, we may have to raise additional funds from the issuance
of equity or debt securities or otherwise restructure our obligations. Any such
financing or restructuring may not be available to us on commercially acceptable
terms, if at all.
If
we cannot raise additional capital, our financial condition will
suffer.
We have
no material credit facility or other material committed sources of capital. To
the extent operating and capital resources are insufficient to meet our future
capital needs, we will have to raise additional funds from new collaboration
partnerships or the capital markets to continue the marketing and development of
our technologies and proprietary products. Such funds may not be available on
favorable terms, if at all. We may be unable to obtain suitable new
collaboration partners on attractive terms and our substantial indebtedness may
limit our ability to obtain additional capital markets financing. If adequate
funds are not available on reasonable terms, we may be required to curtail
operations significantly or obtain funds by entering into financing, supply or
collaboration agreements on unattractive terms. Our inability to raise capital
could harm our business and our stock price. To the extent that additional
capital is raised through the sale of equity or convertible debt securities, the
issuance of such securities would result in dilution to our
stockholders.
30
If government and private insurance
programs do not provide reimbursement for our partnered products or proprietary
products, those products will not be widely accepted, which would have a
negative impact on our business, results of operations and financial
condition.
In both
domestic and foreign markets, sales of our partnered and proprietary products
that have received regulatory approval will depend in part on market acceptance
among physicians and patients, pricing approvals by government authorities and
the availability of reimbursement from third-party payers, such as government
health administration authorities, managed care providers, private health
insurers and other organizations. Such third-party payers are increasingly
challenging the price and cost effectiveness of medical products and services.
Therefore, significant uncertainty exists as to the pricing approvals for, and
the reimbursement status of, newly approved healthcare products. Moreover,
legislation and regulations affecting the pricing of pharmaceuticals may change
before regulatory agencies approve our proposed products for marketing and could
further limit pricing approvals for, and reimbursement of, our products from
government authorities and third-party payers. A government or third-party payer
decision not to approve pricing for, or provide adequate coverage and
reimbursements of, our products would limit market acceptance of such
products.
We depend on third parties to conduct
the clinical trials for our proprietary product candidates and any failure of
those parties to fulfill their obligations could harm our
development and commercialization plans.
We depend
on independent clinical investigators, contract research organizations and other
third-party service providers to conduct clinical trials for our proprietary
product candidates. Though we rely heavily on these parties for successful
execution of our clinical trials and are ultimately responsible for the results
of their activities, many aspects of their activities are beyond our control.
For example, we are responsible for ensuring that each of our clinical trials is
conducted in accordance with the general investigational plan and protocols for
the trial, but the independent clinical investigators may prioritize other
projects over ours or communicate issues regarding our products to us in an
untimely manner. Third parties may not complete activities on schedule or may
not conduct our clinical trials in accordance with regulatory requirements or
our stated protocols. The early termination of any of our clinical trial
arrangements, the failure of third parties to comply with the regulations and
requirements governing clinical trials or our reliance on results of trials that
we have not directly conducted or monitored could hinder or delay the
development, approval and commercialization of our product candidates and would
adversely affect our business, results of operations and financial
condition.
Our manufacturing operations and
those of our contract manufacturers are subject to governmental regulatory
requirements, which, if not met, would have a material adverse effect on our
business, results of operations and financial condition.
We and
our contract manufacturers are required in certain cases to maintain compliance
with current good manufacturing practices (“cGMP”), including cGMP guidelines
applicable to active pharmaceutical ingredients, and are subject to inspections
by the FDA or comparable agencies in other jurisdictions to confirm such
compliance. We anticipate periodic regulatory inspections of our drug
manufacturing facilities and the manufacturing facilities of our contract
manufacturers for compliance with applicable regulatory requirements. Any
failure to follow and document our or our contract manufacturers’ adherence to
such cGMP regulations or satisfy other manufacturing and product release
regulatory requirements may disrupt our ability to meet our manufacturing
obligations to our customers, lead to significant delays in the
availability of products for commercial use or clinical study, result in the
termination or hold on a clinical study or delay or prevent filing or approval
of marketing applications for our products. Failure to comply with applicable
regulations may also result in sanctions being imposed on us, including fines,
injunctions, civil penalties, failure of regulatory authorities to grant
marketing approval of our products, delays, suspension or withdrawal of
approvals, license revocation, seizures or recalls of products, operating
restrictions and criminal prosecutions, any of which could harm our business.
The results of these inspections could result in costly manufacturing changes or
facility or capital equipment upgrades to satisfy the FDA that our manufacturing
and quality control procedures are in substantial compliance with cGMP.
Manufacturing delays, for us or our contract manufacturers, pending resolution
of regulatory deficiencies or suspensions would have a material adverse effect
on our business, results of operations and financial condition.
31
Significant competition for our
polymer conjugate chemistry technology platforms and our partnered and
proprietary products and product candidates could make our technologies, products
or product candidates obsolete or uncompetitive, which would negatively
impact our business, results of operations and financial
condition.
Our
PEGylation and advanced polymer conjugate chemistry platforms and our partnered
and proprietary products and product candidates compete with various
pharmaceutical and biotechnology companies. Competitors of our PEGylation and
polymer conjugate chemistry technologies include The Dow Chemical Company, Enzon
Pharmaceuticals, Inc., SunBio Corporation, Mountain View Pharmaceuticals, Inc.,
Novo Nordisk A/S (formerly assets held by Neose Technologies, Inc.), and NOF
Corporation. Several other chemical, biotechnology and pharmaceutical companies
may also be developing PEGylation technologies or technologies that have similar
impact on target drug molecules. Some of these companies license or provide the
technology to other companies, while others are developing the technology for
internal use.
There are
several competitors for our proprietary product candidates currently in
development. For BAY41-6551 (Amikacin inhale), the current standard of care
includes several approved intravenous antibiotics for the treatment of either
hospital-acquired pneumonia or ventilator-associated pneumonia in patients on
mechanical ventilators. For Oral NKTR-118 (PEGylated naloxol), there are
currently several alternative therapies used to address opioid-induced
constipation (OIC) and opioid-induced bowel dysfunction (OBD), including
over-the-counter laxatives and stool softeners such as docusate sodium, senna
and milk of magnesia. In addition, there are a number of companies developing
potential products which are in various stages of clinical development and are
being evaluated for the treatment of OIC and OBD in different patient
populations, including Adolor Corporation, GlaxoSmithKline plc, Progenics
Pharmaceuticals, Inc., Pfizer (via Wyeth acquisition completed in 2009),
Mundipharma Int. Limited, Sucampo Pharmaceuticals and Takeda Pharmaceutical
Company Limited. For NKTR-102 (PEG-irinotecan), there are a number of approved
therapies for the treatment of colorectal cancer, including Eloxatin, Camptosar,
Avastin, Erbitux, Vectibux, Xeloda, Adrucil and Wellcovorin. In addition, there
are a number of drugs in various stages of preclinical and clinical development
from companies exploring cancer therapies or improved chemotherapeutic agents to
potentially treat colorectal cancer, including, but not limited to, products in
development from Bristol-Myers Squibb Company, Pfizer, Inc., GlaxoSmithKline
plc, Antigenics, Inc., F. Hoffmann-La Roche Ltd, Novartis AG, Cell Therapeutics,
Inc., Neopharm Inc., Meditech Research Ltd, Alchemia Limited, Enzon
Pharmaceuticals, Inc. and others. There are also a number of chemotherapies and
cancer therapies approved today and in various stages of clinical development
for ovarian and breast cancers including but not limited to: Avastin®
(bevacizumab), Camptosar® (irinotecan), Doxil® (doxorubicin HCl ), Ellence®
(epirubicin), Gemzar® (gemcitabine), Herceptin® (trastuzumab), Hycamtin®
(topotecan), Paraplatin® (carboplatin), and Taxol® (paclitaxel). These
therapies are only partially effective in treating ovarian or breast
cancers. Major pharmaceutical or biotechnology companies with approved
drugs or drugs in development for these cancers include Bristol-Meyers Squibb,
Genentech, Inc., GlaxoSmithKline plc, Johnson and Johnson, Pfizer, Inc., Eli
Lilly & Co., and many others.
There can
be no assurance that we or our partners will successfully develop, obtain
regulatory approvals and commercialize next-generation or new products that will
successfully compete with those of our competitors. Many of our competitors have
greater financial, research and development, marketing and sales, manufacturing
and managerial capabilities. We face competition from these companies not just
in product development but also in areas such as recruiting employees, acquiring
technologies that might enhance our ability to commercialize products,
establishing relationships with certain research and academic institutions,
enrolling patients in clinical trials and seeking program partnerships and
collaborations with larger pharmaceutical companies. As a result, our
competitors may succeed in developing competing technologies, obtaining
regulatory approval or gaining market acceptance for products before we do.
These developments could make our products or technologies uncompetitive or
obsolete.
We could be involved in legal
proceedings and may incur substantial litigation costs and liabilities that will
adversely affect our business, results of operations and financial
condition.
From time
to time, third parties have asserted, and may in the future assert, that we or
our partners infringe their proprietary rights. The third party often bases its
assertions on a claim that its patents cover our technology. Similar assertions
of infringement could be based on future patents that may issue to third
parties. In certain of our agreements with our partners, we are obligated to
indemnify and hold harmless our partners from intellectual property
infringement, product liability and certain other claims, which could cause us
to incur substantial costs if we are called upon to defend ourselves and our
partners against any claims. If a third party obtains injunctive or other
equitable relief against us or our partners, they could effectively prevent us,
or our partners, from developing or commercializing, or deriving revenue from,
certain products or product candidates in the U.S. and abroad. For instance, F.
Hoffmann-La Roche Ltd, to which we license our proprietary PEGylation reagent
for use in the MIRCERA product, was a party to a significant patent infringement
lawsuit brought by Amgen Inc. related to Roche’s proposed marketing and sale of
MIRCERA to treat chemotherapy anemia in the U.S. In October 2008, a
federal court ruled in favor of Amgen, issuing a permanent injunction preventing
Roche from marketing or selling MIRCERA in the U.S. In December 2009, the
U.S. District court for the District of Massachusetts entered a final judgment
and permanent injunction, and Roche and Amgen entered into a settlement and
limited license agreement which allows Roche to begin selling MIRCERA in the
U.S. in July 2014.
32
Third-party
claims could also result in the award of substantial damages to be paid by us or
a settlement resulting in significant payments to be made by us. For instance, a
settlement might require us to enter a license agreement under which we pay
substantial royalties to a third party, diminishing our future economic returns
from the related product. In 2006, we entered into a litigation settlement
related to an intellectual property dispute with the University of Alabama in
Huntsville pursuant to which we paid $11.0 million and agreed to pay an
additional $10.0 million in equal $1.0 million installments over ten years
ending with the last payment due on July 1, 2016. We cannot predict with
certainty the eventual outcome of any pending or future litigation. Costs
associated with such litigation, substantial damage claims, indemnification
claims or royalties paid for licenses from third parties could have a material
adverse effect on our business, results of operations and financial
condition.
If product liability lawsuits are
brought against us, we may incur substantial liabilities.
The
manufacture, clinical testing, marketing and sale of medical products involve
inherent product liability risks. If product liability costs exceed our product
liability insurance coverage, we may incur substantial liabilities that could
have a severe negative impact on our financial position. Whether or not we are
ultimately successful in any product liability litigation, such litigation would
consume substantial amounts of our financial and managerial resources and might
result in adverse publicity, all of which would impair our business.
Additionally, we may not be able to maintain our clinical trial insurance or
product liability insurance at an acceptable cost, if at all, and this insurance
may not provide adequate coverage against potential claims or
losses.
Our future depends on the proper
management of our current and future business operations and their associated
expenses.
Our
business strategy requires us to manage our business to provide for the
continued development and potential commercialization of our proprietary and
partnered product candidates. Our strategy also calls for us to undertake
increased research and development activities and to manage an increasing number
of relationships with partners and other third parties, while simultaneously
managing the expenses generated by these activities. If we are unable to manage
effectively our current operations and any growth we may experience, our
business, financial condition and results of operations may be adversely
affected. If we are unable to effectively manage our expenses, we may find it
necessary to reduce our personnel-related costs through further reductions in
our workforce, which could harm our operations, employee morale and impair our
ability to retain and recruit talent. Furthermore, if adequate funds are not
available, we may be required to obtain funds through arrangements with partners
or other sources that may require us to relinquish rights to certain of our
technologies or products that we would not otherwise relinquish.
We are dependent on our management
team and key technical personnel, and the loss of any key manager or employee
may impair our ability to develop our products effectively and may harm our
business, operating results and financial condition.
Our
success largely depends on the continued services of our executive officers and
other key personnel. The loss of one or more members of our management team or
other key employees could seriously harm our business, operating results and
financial condition. The relationships that our key managers have cultivated
within our industry make us particularly dependent upon their continued
employment with us. We are also dependent on the continued services of our
technical personnel because of the highly technical nature of our products and
the regulatory approval process. Because our executive officers and key
employees are not obligated to provide us with continued services, they could
terminate their employment with us at any time without penalty. We do not have
any post-employment noncompetition agreements with any of our employees and do
not maintain key person life insurance policies on any of our executive officers
or key employees.
Because competition for highly
qualified technical personnel is intense, we may not be able to attract and retain the
personnel we need to support our operations and
growth.
We must
attract and retain experts in the areas of clinical testing, manufacturing,
regulatory, finance, marketing and distribution and develop additional expertise
in our existing personnel. We face intense competition from other
biopharmaceutical companies, research and academic institutions and other
organizations for qualified personnel. Many of the organizations with which we
compete for qualified personnel have greater resources than we have. Because
competition for skilled personnel in our industry is intense, companies such as
ours sometimes experience high attrition rates with regard to their skilled
employees. Further, in making employment decisions, job candidates often
consider the value of the stock options they are to receive in connection with
their employment. Our equity incentive plan and employee benefit plans may not
be effective in motivating or retaining our employees or attracting new
employees, and significant volatility in the price of our stock may adversely
affect our ability to attract or retain qualified personnel. If we fail to
attract new personnel or to retain and motivate our current personnel, our
business and future growth prospects could be severely harmed.
33
If earthquakes and other catastrophic
events strike, our business may be harmed.
Our
corporate headquarters, including a substantial portion of our research and
development operations, are located in the San Francisco Bay Area, a region
known for seismic activity and a potential terrorist target. In addition, we own
facilities for the manufacture of products using our PEGylation and advanced
polymer conjugate technologies in Huntsville, Alabama and lease offices in
Hyderabad, India. There are no backup facilities for our manufacturing
operations located in Huntsville, Alabama. In the event of an earthquake or
other natural disaster or terrorist event in any of these locations, our ability
to manufacture and supply materials for drug candidates in development and our
ability to meet our manufacturing obligations to our customers would be
significantly disrupted and our business, results of operations and financial
condition would be harmed. Our collaborative partners may also be subject to
catastrophic events, such as hurricanes and tornadoes, any of which could harm
our business, results of operations and financial condition. We have not
undertaken a systematic analysis of the potential consequences to our business,
results of operations and financial condition from a major earthquake or other
catastrophic event, such as a fire, sustained loss of power, terrorist activity
or other disaster, and do not have a recovery plan for such disasters. In
addition, our insurance coverage may not be sufficient to compensate us for
actual losses from any interruption of our business that may occur.
We have implemented certain
anti-takeover measures, which make it more difficult to acquire us, even though
such acquisitions may be beneficial to our stockholders.
Provisions
of our certificate of incorporation and bylaws, as well as provisions of
Delaware law, could make it more difficult for a third party to acquire us, even
though such acquisitions may be beneficial to our stockholders. These
anti-takeover provisions include:
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establishment of a classified
board of directors such that not all members of the board may be elected
at one time;
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lack of a provision for
cumulative voting in the election of directors, which would otherwise
allow less than a majority of stockholders to elect director
candidates;
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the ability of our board to
authorize the issuance of “blank check” preferred stock to increase the
number of outstanding shares and thwart a takeover
attempt;
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prohibition on stockholder action
by written consent, thereby requiring all stockholder actions to be taken
at a meeting of
stockholders;
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establishment of advance notice
requirements for nominations for election to the board of directors or for
proposing matters that can be acted upon by stockholders at stockholder
meetings; and
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limitations on who may call a
special meeting of
stockholders.
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Further,
we have in place a preferred share purchase rights plan, commonly known as a
“poison pill.” The provisions described above, our “poison pill” and provisions
of Delaware law relating to business combinations with interested stockholders
may discourage, delay or prevent a third party from acquiring us. These
provisions may also discourage, delay or prevent a third party from acquiring a
large portion of our securities or initiating a tender offer or proxy contest,
even if our stockholders might receive a premium for their shares in the
acquisition over the then current market prices. We also have a change of
control severance benefits plan which provides for certain cash severance, stock
award acceleration and other benefits in the event our employees are terminated
(or, in some cases, resign for specified reasons) following an acquisition. This
severance plan could discourage a third party from acquiring us.
Risks
Related to Our Securities
The price of our common stock and
senior convertible debt are expected to remain volatile.
Our stock
price is volatile. During the year ended December 31, 2009, based on closing bid
prices on the NASDAQ Global Select Market, our stock price ranged from $4.03 to
$10.47 per share. We expect our stock price to remain volatile. In addition, as
our convertible senior notes are convertible into shares of our common stock,
volatility or depressed prices of our common stock could have a similar effect
on the trading price of our notes. Also, interest rate fluctuations can affect
the price of our convertible senior notes. A variety of factors may have a
significant effect on the market price of our common stock or notes,
including:
34
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announcements of data from, or
material developments in, our clinical trials or those of our competitors,
including delays in clinical development, approval or
launch;
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announcements by collaboration
partners as to their plans or expectations related to products using our
technologies;
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announcements or terminations of
collaboration agreements by us or our
competitors;
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fluctuations in our results of
operations;
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developments in patent or other
proprietary rights, including intellectual property litigation or entering
into intellectual property license agreements and the costs associated
with those arrangements;
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announcements of technological
innovations or new therapeutic products that may compete with our approved
products or products under
development;
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announcements of changes in
governmental regulation affecting us or our
competitors;
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hedging activities by purchasers
of our convertible senior
notes;
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litigation brought against us or
third parties to whom we have indemnification
obligations;
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public concern as to the safety
of drug formulations developed by us or others;
and
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general market
conditions.
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Our stockholders may be diluted, and
the price of our common stock may decrease, as a result of the exercise
of outstanding stock options and warrants or the future issuances of
securities.
We may
issue additional common stock, preferred stock, restricted stock units or
securities convertible into or exchangeable for our common stock. Furthermore,
substantially all shares of common stock for which our outstanding stock options
or warrants are exercisable are, once they have been purchased, eligible for
immediate sale in the public market. The issuance of additional common stock,
preferred stock, restricted stock units or securities convertible into or
exchangeable for our common stock or the exercise of stock options or warrants
would dilute existing investors and could adversely affect the price of our
securities.
Item 1B. Unresolved Staff
Comments
None.
Item
2. Properties
California
We
currently lease approximately 100,000 square feet of facilities in San Carlos,
California under a capital lease which expires in 2016. The San Carlos facility
is home to our administrative headquarters, as well as research and development
for our PEGylation and advanced polymer conjugate technology
operations.
On
September 30, 2009, we entered into a sublease with Pfizer Inc. for a 102,283
square foot facility located in the Mission Bay Area of San Francisco,
California (the “Mission Bay Facility”). The Mission Bay Facility is
currently under construction and is scheduled to be completed by the end of
2010. When construction is completed, we will relocate all of our
functions currently located in San Carlos, California, including our corporate
headquarters, to the Mission Bay Facility. We are currently seeking a
sublease tenant for our San Carlos facility following our transition to the
Mission Bay Facility.
Until
December 31, 2008, we leased approximately 230,000 additional square feet in San
Carlos, which housed our pulmonary manufacturing facility, as well as research
and development laboratories and administrative offices, under a lease which
expired in 2012. This lease was assigned to Novartis Pharmaceuticals Corporation
in connection with our sale to Novartis of certain of our pulmonary assets on
December 31, 2008.
35
Alabama
We
currently own two facilities consisting of 145,000 square feet in Huntsville,
Alabama, which house laboratories as well as administrative, clinical and
commercial manufacturing facilities for our PEGylation and advanced polymer
conjugate technology operations.
India
We
completed construction of a research and development facility, totaling
approximately 88,000 square feet, near Hyderabad, India at the end of
2009. In addition, we lease approximately 19,000 square feet of
facilities in Hyderabad, India under various operating leases, with expiration
dates ranging from 2010 to 2012.
Item
3. Legal Proceedings
From time
to time, we may be subject to legal proceedings and claims in the ordinary
course of business. We are not currently a party to or aware of any proceedings
or claims that we believe will have, individually or in the aggregate, a
material adverse effect on our business, financial condition or results of
operations.
Item
4. Submission of Matters to a Vote of Security Holders
No
matters were submitted to a vote of our security holders in the three-month
period ended December 31, 2009.
36
PART
II
Item 5. Market for Registrant’s
Common Equity Related Stockholder Matters and Issuer Purchases of Equity
Securities
Our
common stock trades on the NASDAQ Global Select Market under the symbol “NKTR.”
The table below sets forth the high and low closing sales prices for our common
stock as reported on the NASDAQ Global Select Market during the periods
indicated.
High
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Low
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|||||||
Year
Ended December 31, 2008:
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1st
Quarter
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$ | 7.50 | $ | 6.12 | ||||
2nd
Quarter
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7.35 | 3.35 | ||||||
3rd
Quarter
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5.36 | 3.10 | ||||||
4th
Quarter
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5.97 | 2.83 | ||||||
Year
Ended December 31, 2009:
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1st
Quarter
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$ | 5.79 | $ | 4.03 | ||||
2nd
Quarter
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6.94 | 5.02 | ||||||
3rd
Quarter
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10.47 | 5.89 | ||||||
4th
Quarter
|
10.05 | 8.07 |
Holders
of Record
As of
February 26, 2010, there were approximately 285 holders of record of our common
stock.
Dividend
Policy
We have
never declared or paid any cash dividends on our common stock. We currently
expect to retain any future earnings for use in the operation and expansion of
our business and do not anticipate paying any cash dividends on our common stock
in the foreseeable future.
There
were no sales of unregistered securities and there were no common stock
repurchases made during the year ended December 31, 2009.
Securities
Authorized for Issuance Under Equity Compensation Plans
Information
regarding our equity compensation plans as of December 31, 2009 is disclosed in
Item 12 “Security Ownership of Certain Beneficial Owners and Management and
Related Stockholder Matters” of this Annual Report on Form 10-K and is
incorporated herein by reference from our proxy statement for our 2010 annual
meeting of stockholders to be filed with the SEC pursuant to Regulation 14A not
later than 120 days after the end of the fiscal year covered by this Annual
Report on Form 10-K.
Performance
Measurement Comparison
The
material in this section is being furnished and shall not be deemed “filed” with
the SEC for purposes of Section 18 of the Exchange Act or otherwise subject to
the liability of that section, nor shall the material in this section be deemed
to be incorporated by reference in any registration statement or other document
filed with the SEC under the Securities Act or the Exchange Act, except as
otherwise expressly stated in such filing.
The
following graph compares, for the five year period ended December 31, 2009, the
cumulative total stockholder return (change in stock price plus reinvested
dividends) of our common stock with (i) the NASDAQ Composite Index, (ii) the
NASDAQ Pharmaceutical Index, (iii) the RGD SmallCap Pharmaceutical Index, (iv)
the NASDAQ Biotechnology Index and (v) the RDG SmallCap Biotechnology Index.
Measurement points are the last trading day of each of our fiscal years ended
December 31, 2004, December 31, 2005, December 31, 2006, December 31, 2007,
December 31, 2008 and December 31, 2009. The graph assumes that $100 was
invested on December 31, 2004 in the common stock of the Company, the NASDAQ
Composite Index, the Nasdaq Pharmaceutical Index, the RGD SmallCap
Pharmaceutical Index, the NASDAQ Biotechnology Index and the RDG SmallCap
Biotechnology Index and assumes reinvestment of any dividends. The stock price
performance in the graph is not intended to forecast or indicate future stock
price performance.
37
38
Item
6. Selected Financial Data
SELECTED
CONSOLIDATED FINANCIAL INFORMATION
(In
thousands, except per share information)
The
selected consolidated financial data set forth below should be read together
with the consolidated financial statements and related notes, “Management’s
Discussion and Analysis of Financial Condition and Results of Operations,” and
the other information contained herein.
Years ended December 31,
|
||||||||||||||||||||
2009
|
2008
|
2007
|
2006
|
2005
|
||||||||||||||||
Statements
of Operations Data:
|
||||||||||||||||||||
Revenue:
|
||||||||||||||||||||
Product
sales and royalties (1)
|
$ | 35,288 | $ | 41,255 | $ | 180,755 | $ | 153,556 | $ | 29,366 | ||||||||||
License,
collaboration and other revenue (2)
|
36,643 | 48,930 | 92,272 | 64,162 | 96,913 | |||||||||||||||
Total
revenue
|
71,931 | 90,185 | 273,027 | 217, 718 | 126,279 | |||||||||||||||
Total
operating costs and expenses (3)(4)
|
167,063 | 172,837 | 309,175 | 376,948 | 308,912 | |||||||||||||||
Loss
from operations
|
(95,132 | ) | (82,652 | ) | (36,148 | ) | (159,230 | ) | (182,633 | ) | ||||||||||
Gain
(loss) on debt extinguishment
|
— | 50,149 | — | — | (303 | ) | ||||||||||||||
Interest
and other income (expense), net
|
(7,640 | ) | (2,639 | ) | 4,696 | 5,297 | (2,312 | ) | ||||||||||||
Provision
(benefit) for income taxes
|
(253 | ) | (806 | ) | 1,309 | 828 | (137 | ) | ||||||||||||
Net
loss
|
$ | (102,519 | ) | $ | (34,336 | ) | $ | (32,761 | ) | $ | (154,761 | ) | $ | (185,111 | ) | |||||
Basic
and diluted net loss per share (5)
|
$ | (1.11 | ) | $ | (0.37 | ) | $ | (0.36 | ) | $ | (1.72 | ) | $ | (2.15 | ) | |||||
Shares
used in computing basic and diluted net loss per share (5)
|
92,772 | 92,407 | 91,876 | 89,789 | 85,915 |
As of December 31,
|
||||||||||||||||||||
2009
|
2008
|
2007
|
2006
|
2005
|
||||||||||||||||
Balance
Sheet Data:
|
||||||||||||||||||||
Cash,
cash equivalents and investments
|
$ | 396,211 | $ | 378,994 | $ | 482,353 | $ | 466,977 | $ | 566,423 | ||||||||||
Working
capital
|
$ | 260,650 | $ | 337,846 | $ | 425,191 | $ | 369,457 | $ | 450,248 | ||||||||||
Total
assets
|
$ | 575,518 | $ | 560,536 | $ | 725,103 | $ | 768,177 | $ | 858,554 | ||||||||||
Deferred
revenue
|
$ | 192,372 | $ | 65,577 | $ | 80,969 | $ | 40,106 | $ | 23,861 | ||||||||||
Convertible
subordinated notes
|
$ | 214,955 | $ | 214,955 | $ | 315,000 | $ | 417,653 | $ | 417,653 | ||||||||||
Other
long-term liabilities
|
$ | 23,344 | $ | 25,585 | $ | 27,543 | $ | 29,189 | $ | 27,598 | ||||||||||
Accumulated
deficit
|
$ | (1,226,609 | ) | $ | (1,124,090 | ) | $ | (1,089,754 | ) | $ | (1,056,993 | ) | $ | (902,232 | ) | |||||
Total
stockholders’ equity
|
$ | 102,367 | $ | 190,154 | $ | 214,439 | $ | 227,060 | $ | 326,811 |
(1)
|
2006
and 2007 product sales and royalties include commercial manufacturing
revenue from Exubera bulk dry powder insulin and Exubera
inhalers.
|
(2)
|
2007,
2006, and 2005 collaboration and other revenue included Exubera
commercialization readiness revenue.
|
(3)
|
We
changed our method of accounting for stock based compensation on January
1, 2006 in connection with the adoption of SFAS No. 123R, Share-Based
Payment.
|
(4)
|
Operating
costs and expenses includes the Gain on sale of pulmonary assets of $69.6
million in 2008 and the Gain on termination of collaborative agreements,
net of $79.2 million in 2007.
|
(5)
|
Basic
and diluted net loss per share is based upon the weighted average number
of common shares outstanding.
|
39
Item 7. Management’s Discussion and
Analysis of Financial Condition and Results of Operations
The following discussion contains
forward-looking statements that involve risks and uncertainties. Our actual
results could differ materially from those discussed here. Factors that could
cause or contribute to such differences include, but are not limited to,
those discussed in this section as well as factors described in “Part I, Item
1A—Risk Factors.”
Overview
Strategic
Direction of Our Business
We are a
clinical-stage biopharmaceutical company developing a pipeline of drug
candidates that utilize our PEGylation and advanced polymer conjugate technology
platforms to improve the therapeutic benefits of drugs. Our proprietary product
pipeline is comprised of drug candidates across a number of therapeutic areas,
including oncology, pain, anti-infectives and immunology. We create our
innovative product candidates by using our proprietary chemistry platform to
modify the chemical structure of drugs using unique polymer conjugates.
Additionally, we may utilize established pharmacologic targets to engineer a new
drug candidate relying on a combination of the known properties of these targets
and the attributes of our customized polymer chemistry. Our drug candidates are
designed to correct deficiencies in the pharmacokinetics, half-life, oral
bioavailability, metabolism or distribution of drugs to improve their
therapeutic efficacy.
During
2009, we continued to make substantial investments to advance our pipeline of
drug candidates from early stage discovery research through clinical
development. On September 20, 2009, we entered into a License Agreement with
AstraZeneca (the AstraZeneca License) for the worldwide development and
commercialization of NKTR-118 and NKTR-119 (a co-formulated product candidate
including a long-acting opioid and NKTR-118). We have several Phase 2 clinical
trials for NKTR-102 (PEGylated irinotecan) directed at a number of different
indications in the oncology therapeutic area that we were advancing during 2009
and we expect to continue in 2010. In January 2010, we announced
preliminary results from stage one of the ongoing Phase 2 development program
for NKTR-102 for platinum resistant ovarian cancer patients. In
February 2009, we announced that we had dosed the first patient in a Phase 1
clinical trial for NKTR-105 (PEGylated docetaxel) for patients with refractory
solid tumors and this clinical trial is currently ongoing. We also
have other products in the early discovery research or preclinical
development.
Our focus
on research and clinical development requires substantial investments that
continue to increase as we advance each drug candidate through each phase of the
development cycle. While we believe that our strategy has the potential to
create significant value if one or more of our drug candidates demonstrates
positive clinical results and/or receives regulatory approval in one or more
major markets, drug development is an inherently uncertain process and there is
a high risk of failure at every stage prior to approval and the timing and
outcome of clinical trial results are very difficult to predict. Clinical
development success and failures can have an unpredictable and disproportionate
positive or negative impact on our scientific and medical prospects, financial
prospects, financial condition, and market value.
We decide
on a program-by-program basis whether we wish to continue development into Phase
3 pivotal clinical trials and commercialize products on our own, or seek a
partner, or pursue a combination of these approaches. Following completion of
Phase 2 development, or earlier in the development cycle in certain
circumstances, we will generally be seeking collaborations with one or more
biotechnology or pharmaceutical companies to conduct Phase 3 clinical
development, to be responsible for the regulatory approval process and, if such
drug candidate is approved, to market and sell the drug in one or more global
markets. To date, we have partnered our proprietary drug development
programs prior to Phase 3 clinical development. For example, we
intend to seek a collaboration partner for NKTR-102 prior to commencing any
Phase 3 clinical trials for this drug candidate. Whether we ultimately
enter into a collaboration agreement for NKTR-102 will depend on the partnership
opportunities available to us. The financial terms of such future
collaborations, if any, including, without limitation, upfront payments,
development and sales milestone payments, and royalty rates, will be critical to
the future prospects of our business and financial condition. There can be no
assurance that any future collaborations will be available to us for NKTR-102 or
other of our development programs, on favorable terms or at all.
We also
have a number of existing license and collaboration agreements with third
parties who have licensed our proprietary technologies for drugs that have
either received regulatory approval in one or more markets or drug candidates
that are still in the clinical development stage. For example, the future
clinical and commercial success of Bayer’s Amikacin Inhale (BAY41-6551 or
NKTR-061), UCB’s CIMZIA™ , Roche’s MIRCERA and Affymax’s Hematide, among others,
will together have a material impact on our long-term financial results and
financial condition, as will the success of Bayer’s Cipro Inhale program, in
relation to which we have certain royalty rights. Because drug development and
commercialization is subject to numerous risks and uncertainties, there is a
risk that our future revenue from one or more of these agreements will be less
than we anticipate.
40
Historically,
we entered into a number of license and supply contracts under which we
manufactured and supplied proprietary PEGylation reagents on a cost-plus or
fixed price basis. Our current strategy is to manufacture and supply
PEGylation reagents to support our proprietary drug candidates or for third
party collaborators where we have a strategic development and commercialization
relationship. As a result, whenever possible, we are
renegotiating or not seeking renewal of legacy manufacturing supply arrangements
that do not include a strategic development or commercialization
component. While this will result in some revenue loss in the
short-term, product sales from these legacy agreements is generally
low-margin. Our strategy allows us to focus our proprietary
manufacturing expertise and capacity on drugs and drug candidates where we have
significant future economic opportunity.
Key
Developments and Trends in Liquidity and Capital Resources
At
December 31, 2009, we had approximately $396.2 million in cash, cash
equivalents, and short-term investments and $240.7 million in indebtedness. We
may from time to time purchase or retire convertible subordinated notes through
cash purchase or exchanges for our other securities in open market or privately
negotiated transactions, depending on, among other factors, our levels of
available cash and the price at which such convertible notes are available for
purchase. For instance, in the fourth quarter of 2008, we repurchased
approximately $100.0 million in par value of our 3.25% convertible subordinated
notes for an aggregate purchase price of $47.8 million. We will evaluate similar
future transactions, if any, in light of then-existing market conditions. These
transactions, individually or in the aggregate, may be material to our
business.
In 2010,
we plan to relocate all of our functions currently located in San Carlos,
California, including our corporate headquarters, to the Mission Bay area of San
Francisco, California, which we have subleased from Pfizer Inc. In
connection with the move, we expect to spend approximately $25.0 million for
tenant improvements to complete the Mission Bay Facility and office and
laboratory equipment in 2010.
We have
financed our operations primarily through revenue from product sales and
royalties, development and commercialization collaboration contracts and debt
and equity financings. In October 2009, we received a payment of $125.0 million
from AstraZeneca under the AstraZeneca License as an upfront payment for the
worldwide rights to further develop and commercialize Oral NKTR-118 and
NKTR-119. In December 2009, we also received a payment of $31.0
million from the exercise of a license option extension by one of our existing
collaboration partners. Similar to 2009, the results of our
collaboration partnering efforts will also have a material impact on our cash
position at the end of 2010. To date we have incurred substantial
debt as a result of our issuances of subordinated notes that are convertible
into our common stock. Our substantial debt, the market price of our securities,
and the general economic climate, among other factors, could have material
consequences for our financial condition and could affect our sources of
short-term and long-term funding. Our ability to meet our ongoing operating
expenses and repay our outstanding indebtedness is dependent upon our and our
partners’ ability to successfully complete clinical development of, obtain
regulatory approvals for and successfully commercialize new drugs. Even if we or
our partners are successful, we may require additional capital to continue to
fund our operations and repay our debt obligations as they become due. There can
be no assurance that additional funds, if and when required, will be available
to us on favorable terms, if at all.
Results
of Operations
Years
Ended December 31, 2009, 2008, and 2007
|
Revenue
(in thousands, except percentages)
|
Years ended December 31,
|
Increase/
(Decrease)
|
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
||||||||||||||||||||||||
2009
|
2008
|
2007
|
2009 vs. 2008
|
2008 vs. 2007
|
2009 vs. 2008
|
2008 vs. 2007
|
||||||||||||||||||||||
Product
sales and royalties
|
$ | 35,288 | $ | 41,255 | $ | 180,755 | $ | (5,967 | ) | $ | (139,500 | ) | (14 | )% | (77 | )% | ||||||||||||
License,
collaboration and other
|
36,643 | 48,930 | 92,272 | (12,287 | ) | (43,342 | ) | (25 | )% | (47 | )% | |||||||||||||||||
Total
revenue
|
$ | 71,931 | $ | 90,185 | $ | 273,027 | $ | (18,254 | ) | $ | (182,842 | ) | (20 | )% | (67 | )% |
Total
revenue decreased for the year ended December 31, 2009 compared to the year
ended December 31, 2008 primarily as a result of the sale of certain of our
pulmonary assets to Novartis completed on December 31, 2008 (Novartis Pulmonary
Asset Sale) and lower product manufacturing volumes required by our
collaboration partners. In connection with the Novartis Pulmonary
Asset Sale, our collaboration agreement with Novartis for TIP was terminated and
our collaboration agreement with Bayer Schering Pharma AG for Cipro Inhale was
assigned to Novartis. For the year ended December 31, 2009, two of
our partners, AstraZeneca AB and UCB Pharma, represented 35% and 17%,
respectively, of our total revenue.
41
For the
year ended December 31, 2008, the decrease in total revenue from the year ended
December 31, 2007 was primarily attributable to the termination of our
collaboration agreements with Pfizer related to Exubera and NGI, which accounted
for $182.4 million, or 67%, of our total revenue during the year ended December
31, 2007. We had no revenue from Pfizer related to Exubera or NGI for the year
ended December 31, 2008 or 2009. Four of our customers, Bayer (including Bayer
Healthcare LLC and Bayer Schering Pharma AG), UCB Pharma, Novartis, and Roche
represented 24%, 16%, 15%, and 14%, respectively, of our total revenue during
the year ended December 31, 2008.
Product
sales and royalties
Product
sales include cost-plus and fixed price manufacturing and supply agreements with
our collaboration partners. We also receive royalty revenue from
certain of our collaboration partners based on their net sales once their
products are approved for commercial sale. Royalty revenues were $5.2
million, $3.5 million, and $3.7 million for the years ended December 31, 2009,
2008, and 2007, respectively. In 2010, we expect product sales and
royalties to remain at approximately the same level as 2009.
Lower
product demand from our collaboration partners resulted in decreased product
sales of approximately $7.7 million for the year ended December 31, 2009
compared to the year ended December 31, 2008. For the year ended
December 31, 2009, an increase in royalties of approximately $1.7 million
partially offset the decrease in product sales compared to the year ended
December 31, 2008.
For the
year ended December 31, 2007, Exubera product sales to Pfizer accounted for
$132.9 million of our total revenue. We had no revenue from Pfizer related to
Exubera for the year ended December 31, 2008 or 2009. Non-Exubera product sales
and royalties decreased by approximately $6.6 million, or 14%, for the year
ended December 31, 2008, compared to the year ended December 31, 2007. The
decrease in non-Exubera product sales and royalties is primarily attributable to
the November 30, 2007 sale of Aerogen Ireland Ltd., one of our former
subsidiaries that manufactured and supplied general purpose nebulizer devices,
which accounted for $5.5 million in revenue for the year ended December 31,
2007.
License,
collaboration and other revenue
License,
collaboration and other revenue includes amortization of upfront payments and
performance milestone payments received in connection with our license and
collaboration agreements and reimbursed research and development
expenses. The level of license, collaboration and other revenues
depends in part upon the estimated amortization period of the upfront and
milestone payments, the achievement of future milestones, the continuation of
existing collaborations, the amount of reimbursed research and development work,
and the signing of new collaborations.
The
decrease in License, collaboration and other revenue for the year ended December
31, 2009 compared to the year ended December 31, 2008 is primarily attributable
to elimination of any revenue from Novartis related to TIP and from Bayer
Schering Pharma AG for Cipro Inhale as a result of the Novartis Pulmonary Asset
Sale. In addition, 2008 included revenue related to a new
intellectual property license agreement we entered into with Roche and higher
revenue from Bayer under our collaboration agreement for BAY41-6551. This
decrease is partially off-set by $25.1 million in revenue recognized related to
our agreement with AstraZeneca for NKTR-118 and NKTR-119. In 2009, we recognized
$23.6 million of the $125.0 million upfront payment received form AstraZeneca
and $1.5 million in reimbursement of technology transfer costs incurred by
us. We expect to recognize the remainder of this upfront payment in
2010.
We expect
License, collaboration and other revenue to increase in 2010 due to the
recognition of the remaining amount of the upfront payment we received from the
AstraZeneca collaboration transaction.
For the
year ended December 31, 2007, License, collaboration and other revenue from
Pfizer related to Exubera and NGI accounted for $49.5 million of our License,
collaboration and other revenue. We had no collaboration and other revenue from
Pfizer related to Exubera or NGI for the year ended December 31, 2008 or the
year ended December 31, 2009. The increase in non-Pfizer collaboration and other
revenue of $6.1 million during the year ended December 31, 2008 compared to the
year ended December 31, 2007 is primarily attributable to revenue received from
an intellectual property license agreement with Roche that we entered into in
2008. For the year ended December 31, 2008, we have recognized
increased License, collaboration and other revenue from Bayer (including Bayer
Healthcare LLC and Bayer Schering Pharma AG) of $12.3 million under our
collaboration agreements for BAY41-6551 and Cipro Inhale. These increases are
offset by decreased collaboration and other revenue of $3.3 million from
Novartis Vaccines and Diagnostics, Inc. under our collaboration agreement for
TIP and of $3.7 million from Solvay Pharmaceuticals, Inc. and Zelos Therapeutics
Inc. following the termination of those collaboration agreements in
2008.
42
The
timing and future success of our drug development programs and those of our
collaboration partners are subject to a number of risks and uncertainties. See
“Part I, Item 1A—Risk Factors” for discussion of the risks associated with our
partnered research and development programs.
Revenue
by geography
Revenue
by geographic area is based on locations of our partners. The following table
sets forth revenue by geographic area (in thousands):
Years ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
United
States
|
$ | 29,511 | $ | 30,800 | $ | 212,990 | ||||||
European
countries
|
42,420 | 59,385 | 60,037 | |||||||||
Total
revenue
|
$ | 71,931 | $ | 90,185 | $ | 273,027 |
The
decrease in revenue attributable to the United States for the year ended
December 31, 2008 compared to the year ended December 31, 2007 is primarily
attributable to the termination of our Exubera collaboration with Pfizer in
2007.
Cost
of goods sold (in thousands, except percentages)
Years ended December 31,
|
Increase/
(Decrease)
|
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
||||||||||||||||||||||||
2009
|
2008
|
2007
|
2009 vs. 2008
|
2008 vs. 2007
|
2009 vs. 2008
|
2008 vs. 2007
|
||||||||||||||||||||||
Cost
of goods sold
|
$ | 30,948 | $ | 28,216 | $ | 137,696 | $ | 2,732 | $ | (109,480 | ) | 10 | % | (80 | )% | |||||||||||||
Product
gross profit
|
4,340 | 13,039 | 43,059 | (8,699 | ) | (30,020 | ) | (67 | )% | (70 | )% | |||||||||||||||||
Product
gross margin
|
12 | % | 32 | % | 24 | % |
The
decrease to product gross margin during the year ended December 31, 2009
compared to the year ended December 31, 2008 is primarily attributable to lower
manufacturing volumes and a $2.1 million success fee that became due to one of
our former consulting firms as the final payment due under the agreement in
2009.
The
decrease in cost of goods sold and product gross margin during the year ended
December 31, 2008 compared to the year ended December 31, 2007 was primarily due
to the termination of our Exubera collaboration agreement with Pfizer. During
the year ended December 31, 2007, Exubera cost of goods sold was $103.6 million
and Exubera gross margin was $29.3 million. The increase in product gross margin
percentage resulted from the change in product mix with our product sales based
on our proprietary PEGylation materials having a relatively higher gross margin
than Exubera.
Cost of
goods sold during the year ended December 31, 2007 includes Exubera
manufacturing costs through the November 9, 2007 termination of the Pfizer
agreements. Costs related to our Exubera manufacturing operations after November
9, 2007 are included in other cost of revenue.
As a
result of the fixed cost base associated with our manufacturing activities, we
expect product gross margin to fluctuate in future periods depending on the
level of manufacturing orders from our customers.
Other
cost of revenue (in thousands, except percentages)
Years ended December 31,
|
Increase/
(Decrease)
|
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
||||||||||||||||||||||||
2009
|
2008
|
2007
|
2009 vs. 2008
|
2008 vs. 2007
|
2009 vs. 2008
|
2008 vs. 2007
|
||||||||||||||||||||||
Other
cost of revenue
|
$ | — | $ | 6,821 | $ | 9,821 | $ | (6,821 | ) | $ | (3,000 | ) | n/a | (31 | )% |
43
Other
cost of revenue included the idle Exubera manufacturing capacity costs that were
incurred by us prior to the termination of all of our inhaled insulin programs
in April 2008 and Exubera commercialization readiness costs incurred in
2007.
Idle
Exubera manufacturing capacity costs includes the costs of maintaining our
manufacturing operating capacity after the termination of the Pfizer agreements
on November 9, 2007 through the termination of our inhaled insulin programs on
April 9, 2008. Idle Exubera manufacturing capacity costs include amounts payable
to Pfizer and Tech Group under interim manufacturing capacity maintenance
agreements and an allocation of manufacturing costs shared between commercial
operations and research and development, including employee compensation and
benefits, rent, and utilities. Idle Exubera manufacturing costs were nil, $6.8
million, and $6.3 million for the year ended December 31, 2009, 2008, and 2007,
respectively.
Exubera
commercialization readiness costs were start-up manufacturing costs we incurred
in our Exubera inhalation bulk powder manufacturing facility and our Exubera
inhaler device third party contract manufacturing locations in preparation for
commercial scale manufacturing beginning in early 2006. Exubera
commercialization readiness costs were nil, nil, and $3.5 million for the years
ended December 31, 2009, 2008, and 2007, respectively.
We do not
expect to incur any additional idle Exubera manufacturing capacity or Exubera
commercialization readiness costs.
Research
and development expense (in thousands, except percentages)
Years ended December 31,
|
Increase/
(Decrease)
|
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
||||||||||||||||||||||||
2009
|
2008
|
2007
|
2009 vs. 2008
|
2008 vs. 2007
|
2009 vs. 2008
|
2008 vs. 2007
|
||||||||||||||||||||||
Research
& development expense
|
$ | 95,109 | $ | 154,417 | $ | 153,575 | $ | (59,308 | ) | $ | 842 | (38 | )% | 1 | % |
Research
and development expense consists primarily of personnel costs, including
salaries, benefits and stock-based compensation, clinical studies performed by
contract research organizations (CROs), materials and supplies, licenses and
fees and overhead allocations consisting of various support and facilities
related costs.
The costs
incurred in connection with our research and development programs, including an
allocation of shared resources and overhead costs to programs, are as
follows (in thousands):
Clinical
|
Years ended December 31,
|
||||||||||||||
Study Status(1)
|
2009
|
2008
|
2007
|
||||||||||||
NKTR-102
(PEGylated irinotecan)
|
Phase
2
|
$ | 31,500 | $ | 24,205 | $ | 12,741 | ||||||||
NKTR-118
(oral PEGylated naloxol)(2)
|
Phase
2
|
20,276 | 24,579 | 12,852 | |||||||||||
BAY41-6551
(NKTR-061, Amikacin Inhale) (3)
|
Phase
2
|
13,621 | 17,676 | 15,196 | |||||||||||
NKTR-105
(PEGylated docetaxel)
|
Phase
1
|
4,986 | 8,384 | 400 | |||||||||||
Other
PEGylation product candidates
|
Various
|
24,460 | 21,030 | 16,165 | |||||||||||
Tobramycin
inhalation powder (TIP)(4)
|
n/a
|
— | 19,674 | 16,255 | |||||||||||
Cipro
Inhale(5)
|
n/a
|
— | 11,447 | 8,321 | |||||||||||
Inhaled
Insulin(6)
|
n/a
|
— | 3,511 | 37,647 | |||||||||||
Other
pulmonary product candidates(7)
|
Various
|
166 | 17,990 | 28,107 | |||||||||||
Other
|
100 | 5,921 | 5,891 | ||||||||||||
Research
and development expense
|
$ | 95,109 | $ | 154,417 | $ | 153,575 |
(1)
|
Clinical
Study Status definitions are provided in the chart found in Part I, Item
1. Business.
|
(2)
|
Partnered
with AstraZeneca AB on September 20,
2009.
|
(3)
|
Partnered
with Bayer Healthcare LLC in August 2007. As part of the Novartis
Pulmonary Asset Sale, we retained an exclusive license to this technology
for the development and commercialization of this product which was
originally developed by Nektar.
|
(4)
|
The
collaboration agreement with Novartis was terminated on December 31, 2008
in connection with the Novartis Pulmonary Asset
Sale.
|
(5)
|
The
collaboration agreement with Bayer Schering Pharma AG was assigned to
Novartis on December 31, 2008 in connection with the Novartis Pulmonary
Asset Sale.
|
(6)
|
Partnership
for the collaboration and development of Exubera inhalation powder and the
next generation inhaled insulin with Pfizer was terminated on November 9,
2007. We terminated all of our inhaled insulin programs in April
2008.
|
(7)
|
Certain
proprietary pulmonary intellectual property was transferred to Novartis as
part of the Novartis Pulmonary Asset
Sale.
|
44
In
connection with the Novartis Pulmonary Asset Sale, we transferred approximately
140 of our personnel dedicated to our pulmonary operations and our San Carlos
research and manufacturing facility to Novartis. In addition, we ceased research
activities on the TIP research and development program, the Cipro Inhale program
and certain other proprietary pulmonary development programs. During
2009, we had several Phase 2 clinical trials ongoing for NKTR-102 with treatment
sites around the world for ovarian, breast, and colorectal cancers; we completed
our Phase 2 clinical trial for NKTR-118 in March 2009 and performed development
activities to prepare for a Phase 3 clinical trial; we continued to develop the
nebulizer device for BAY41-6551 in preparation for the Phase 3 clinical trial
that we are targeting to start in 2010; and we continued to enroll patients in
our Phase 1 clinical trial for NKTR-105. The decrease in
research and development expense for the year ended December 31, 2009 compared
to the year ended December 31, 2008 is primarily attributable to the divestiture
of certain pulmonary research and development programs as part of the Novartis
Pulmonary Asset Sale. Research and development expense related to
terminated pulmonary programs totaled $52.6 million for the year ended December
31, 2008 which was comprised of facility, employee related and other
costs. Additionally, in 2008 we recorded approximately $5.9 million
in other expenses related to the workforce reduction executed in February 2008
and additional severance costs related to the Novartis Pulmonary Asset
Sale.
We expect
research and development expense will increase in 2010 as compared to 2009, as
we complete or continue the Phase 2 clinical trials for NKTR-102 and the Phase 1
clinical trial for NKTR-105 and advance various product candidates through the
research and pre-clinical phase.
Research
and development expense remained at a consistent level in 2008 as compared to
2007 despite a significant increase in our investment in clinical development of
our proprietary drug candidates in 2008. This was a result of the continued
transition of our business to focus on our internal proprietary drug candidates
in 2008 and a decrease in other research and development
activities.
Salaries,
benefits, and stock-based compensation expense decreased by approximately $14.0
million for the year ended December 31, 2008 compared to the year ended December
31, 2007, as we continued to realize the benefits of our workforce reduction
plans implemented in May 2007 and February 2008. Facilities and equipment
expense decreased by approximately $8.0 million primarily as a result of lower
depreciation due to the write-off of the Pfizer-related equipment in 2007 and
certain pulmonary property and equipment classified as held for sale at
September 30, 2008. These decreases were offset by increased costs related to
our ongoing clinical trials for our proprietary drug candidates, comprised
increased outside services of $13.4 million, including costs to CROs, and
increased materials and supplies expense of $8.2 million. During the year ended
December 31, 2008, research and development expense included approximately $2.7
million in additional costs related to the Novartis Pulmonary Asset Sale,
including one-time termination benefits and other costs. During the
year ended December 31, 2008, our research and development spending in our
partnered drug development programs decreased compared to the year ended
December 31, 2007 after the termination of our Pfizer agreements for inhaled
insulin in November 2007. Spending related to our proprietary drug development
programs increased as we continued to advance clinical development for NKTR-102,
NKTR-118, and NKTR-105.
The
estimated completion dates for our programs are not reasonably certain. See Item
1a. Risk Factors for discussion of the risks associated with drug candidates in
development and the risks and uncertainties associated with clinical development
at any stage.
General
and administrative expense (in thousands, except percentages)
Years ended December 31,
|
Increase/
(Decrease)
|
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
||||||||||||||||||||||||
2008
|
2008
|
2007
|
2009 vs. 2008
|
2008 vs. 2007
|
2009 vs. 2008
|
2008 vs. 2007
|
||||||||||||||||||||||
General
& administrative expense
|
$ | 41,006 | $ | 51,497 | $ | 58,865 | $ | (10,491 | ) | $ | (7,368 | ) | (20 | )% | (13 | )% |
General
and administrative expenses are associated with administrative staffing,
business development, finance, marketing, and legal.
The
decrease in general and administrative expenses for the year ended December 31,
2009 compared to the year ended December 31, 2008, is primarily attributable to
decreased employee compensation costs of $4.1 million, decreased professional
fees of $4.3 million, and decreased marketing costs of $1.7 million due to our
election to terminate our co-promotion rights and obligations under the
collaboration agreement with Bayer for BAY41-6551. In 2010, we expect
general and administrative expenses to remain at a level consistent with
2009.
45
The
decrease in general and administrative expenses for the year ended December 31,
2008 compared to the year ended December 31, 2007 is primarily attributable to
decreased professional fees of $5.1 million and decreased salaries and benefits
of $8.8 million, partially offset by increased marketing costs of $1.7 million
related to our co-promotion obligations with Bayer Healthcare LLC for BAY41-6551
and decreased corporate overhead costs allocated out of general and
administrative departments to manufacturing and research and development of $4.0
million.
Impairment
of long lived assets (in thousands except percentages)
Years ended December 31,
|
Increase/
(Decrease)
|
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
||||||||||||||||||||||||
2009
|
2008
|
2007
|
2009 vs. 2008
|
2008 vs. 2007
|
2009 vs. 2008
|
2008 vs. 2007
|
||||||||||||||||||||||
Impairment
of long-lived assets
|
$ | - | $ | 1,458 | $ | 28,396 | $ | (1,458 | ) | $ | (26,938 | ) | n/a | (95 | )% |
During
the year ended December 31, 2008, impairment of long lived assets included an
impairment charge of $1.5 million related to a specialized dryer designed for
our PEGylation manufacturing facility. The dryer was not functioning properly
and was not being used in operations. We determined the carrying value of the
manufacturing equipment exceeded the fair value based on a discounted cash flow
model.
During
the year ended December 31, 2007, impairment of long lived assets includes an
impairment charge of $28.4 million for Exubera-related assets following the
termination of our collaborative agreements with Pfizer.
Gain
on sale of pulmonary assets (in thousands except percentages)
Years ended December 31,
|
Increase/
(Decrease)
|
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
||||||||||||||||||||||||
2009
|
2008
|
2007
|
2009 vs. 2008
|
2008 vs. 2007
|
2009 vs. 2008
|
2008 vs. 2007
|
||||||||||||||||||||||
Gain
on sale of pulmonary assets
|
$ | — | $ | (69,572 | ) | $ | — | $ | (69,572 | ) | $ | 69,572 | n/a | n/a |
On
December 31, 2008, we sold certain of our pulmonary assets to Novartis for
$115.0 million. The gain on sale of pulmonary assets includes the purchase price
received from Novartis less the net book value of property and equipment of
$37.3 million, an equity investment in Pearl Therapeutics, Inc. of $2.7 million,
transaction costs of $4.6 million, and other costs of $0.9 million.
Gain on termination of collaborative
agreements, net (in thousands except percentages)
Years ended December 31,
|
Increase/
(Decrease)
|
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
||||||||||||||||||||||||
2009
|
2008
|
2007
|
2009 vs. 2008
|
2008 vs. 2007
|
2009 vs. 2008
|
2008 vs. 2007
|
||||||||||||||||||||||
Gain
on termination of collaborative agreements, net
|
$ | — | $ | — | $ | (79,178 | ) | $ | — | $ | (79,178 | ) | n/a | n/a |
On
November 9, 2007, we terminated our collaborative development and license
agreement with Pfizer and all other agreements between us and Pfizer related to
Exubera and NGI. Pursuant to the termination agreement, we received a one-time
payment of $135.0 million from Pfizer in full satisfaction and release of all
contract obligations. The gain on termination of collaborative agreements, net,
includes the Pfizer termination payment received of $135.0 million less our
contractual aggregate liability to certain subcontractors, Bespak and Tech
Group, of $32.4 million and less settlement of outstanding receivables and
payables with Pfizer of $23.5 million.
Interest
income (in thousands except percentages)
Years ended December 31,
|
Increase/
(Decrease)
|
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
||||||||||||||||||||||||
2009
|
2008
|
2007
|
2009 vs. 2008
|
2008 vs. 2007
|
2009 vs. 2008
|
2008 vs. 2007
|
||||||||||||||||||||||
Interest
income
|
$ | 3,688 | $ | 12,495 | $ | 22,201 | $ | (8,807 | ) | $ | (9,706 | ) | (70 | )% | (44 | )% |
46
The
decreases in interest income for the years ended December 31, 2009 and 2008
compared to the previous years, was primarily attributable to lower interest
rates on our cash, cash equivalents, and available-for-sale
investments.
Interest
expense (in thousands except percentages)
Years ended December 31,
|
Increase/
(Decrease)
|
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
||||||||||||||||||||||||
2009
|
2008
|
2007
|
2009 vs. 2008
|
2008 vs. 2007
|
2009 vs. 2008
|
2008 vs. 2007
|
||||||||||||||||||||||
Interest
expense
|
$ | 12,176 | $ | 15,192 | $ | 18,638 | $ | (3,016 | ) | $ | (3,446 | ) | (20 | )% | (18 | )% |
We
repurchased $100.0 million par value of our 3.25% convertible subordinated notes
(Notes) in the fourth quarter of 2008. This resulted in a lower
average balance of Notes outstanding and a corresponding decrease in interest
expense in 2009 compared to 2008 and in 2008 compared to 2007. The
Notes are due in September 2012. We expect 2010 interest expense to
remain at a level consistent with 2009.
Gain
on debt extinguishment (in thousands except percentages)
Years ended December 31,
|
Increase/
(Decrease)
|
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
Percentage
Increase/
(Decrease)
|
||||||||||||||||||||||||
2009
|
2008
|
2007
|
2009 vs. 2008
|
2008 vs. 2007
|
2008 vs. 2007
|
2008 vs. 2007
|
||||||||||||||||||||||
Gain
on debt extinguishment
|
$ | — | $ | 50,149 | $ | — | $ | (50,149 | ) | $ | 50,149 | n/a | n/a |
During
the three months ended December 31, 2008, we repurchased approximately $100.0
million in par value of our 3.25% convertible subordinated notes for an
aggregate purchase price of $47.8 million. The recognized gain on debt
extinguishment is net of transaction costs of $1.0 million and accelerated
amortization of our deferred financing costs of $1.1 million.
Liquidity
and Capital Resources
We have
financed our operations primarily through revenue from product sales, royalties
and research and development contracts, as well as public and private placements
of debt and equity. As of December 31, 2009, we had cash, cash equivalents and
investments in marketable securities of $396.2 million and indebtedness of
$240.7 million, including $215.0 million of convertible subordinated notes,
$20.3 million in capital lease obligations and $5.4 million in other
liabilities. Additionally at December 31, 2009, we had letter of credit
arrangements with certain financial institutions and vendors, including our
landlord, totaling $2.9 million. These letters of credit expire during 2010 and
are secured by investments of similar amounts.
Due to
the continuing difficult environment in the credit markets, we may experience
reduced liquidity with respect to some of our short-term investments. These
investments are generally held to maturity, which is less than one year.
However, if the need arose to liquidate such securities before maturity, we may
experience losses on liquidation. As of December 31, 2009, we held $363.1
million of available-for-sale investments, excluding money market funds, with an
average time to maturity of 153 days. Based on our available cash and
our expected operating cash requirements, we do not intend to sell these
securities and it is more likely than not that we will not be required to sell
these securities before we recover the amortized cost basis. To date
we have not experienced any liquidity issues with respect to these securities,
but should such issues arise, we may be required to hold some, or all, of these
securities until maturity. We believe that, even allowing for potential
liquidity issues with respect to these securities, our remaining cash and cash
equivalents and short-term investments will be sufficient to meet our
anticipated cash needs for at least the next twelve months.
On
September 30, 2009, we entered into a sublease with Pfizer Inc. for a 102,283
square foot facility located in the Mission Bay Area of San Francisco,
California (Mission Bay Facility). The Mission Bay Facility is
currently under construction and is scheduled to be completed by the end of
2010. We anticipate that our capital requirements for 2010 related to
the Mission Bay Facility will total approximately $25.0 million for tenant
improvements and office and laboratory equipment. When construction
is completed, we will relocate all of our functions currently located in San
Carlos, California, including our corporate headquarters, to the Mission Bay
Facility. We are currently seeking a sublease tenant for our San
Carlos facility following our transition to the Mission Bay
Facility.
47
Cash
flows from operating activities
During
the year ended December 31, 2009, net cash provided by operating activities
totaled $39.7 million, which included the $125.0 million upfront payment
received from AstraZeneca under the license agreement we entered into for
NKTR-118 and NKTR-119 and $31.0 million license extension payment received from
Roche in December 2009. In 2010, we expect that 2010 cash flows from
operating activities, excluding upfront payments received, if any, will increase
in 2009 as a result of increased spending on our proprietary research and
development programs.
During
the year ended December 31, 2008, net cash used for our operating activities was
$145.8 million. The decrease in net cash provided by our operating activities
for the year ended December 31, 2008 as compared to the year ended December 31,
2007, resulted from the $135.0 million cash payment received from Pfizer in 2007
under the Exubera termination agreement and upfront payments of $50.0 million
and $24.6 million received in 2007 from Bayer Healthcare LLC and Pfizer,
respectively. In addition, the net cash used for our operating activities for
the year ended December 31, 2008 included a number of significant items
including a $10.0 million clinical development milestone received from Bayer
Healthcare LLC under our collaboration agreement for BAY41-6551, payments by us
to Bespak Europe Ltd. and Tech Group North America, Inc. of $39.9 million for
amounts due under termination agreements with these Exubera inhaler device
contract manufacturers, all of which was recorded as an expense in 2007, $6.8
million paid to maintain Exubera manufacturing capacity through April 2008, and
$5.4 million for severance, employee benefits, and outplacement services in
connection with our workforce reduction plans.
Cash
flows from investing activities
We
purchased $16.4 million, $18.9 million, and $32.8 million of property and
equipment in the years ended December 31, 2009, 2008, and 2007, respectively.
Additionally, we made advanced payments on property and equipment purchases of
$4.3 million in the year ended December 31, 2009. We expect our
capital expenditures to increase in 2010, as we construct the leasehold
improvements for the Mission Bay sublease and complete our research and
development facility in Hyderabad, India.
On
December 31, 2008, we completed the sale of certain pulmonary assets to Novartis
for a purchase price of $115.0 million. We paid $0.2 million in transaction
costs related to the sale during the year ended December 31, 2008 and $4.4
million in transaction costs during the year ended December 31,
2009.
In July
2008, we invested $4.2 million in Pearl Therapeutics Inc. (Pearl). In 2007, we
granted Pearl a limited field intellectual property license to certain of our
proprietary pulmonary delivery technology. In connection with the Novartis
Pulmonary Asset Sale, we transferred our ownership interest in Pearl to Novartis
and assigned the intellectual property license we had in place with Pearl to
Novartis.
Cash
flows used in financing activities
During
the year ended December 31, 2008, we repurchased approximately $100.0 million in
par value of our 3.25% convertible subordinated notes for an aggregate purchase
price of $47.8 million. The $215.0 million of 3.25% convertible subordinated
notes outstanding at December 31, 2008, are due in September 2012. We
repaid $102.7 million of convertible subordinated notes during the year ended
December 31, 2007.
Contractual
Obligations
Payments due by period
|
||||||||||||||||||||
Total
|
<=1 yr
2010
|
2-3 yrs
2011-2012
|
4-5 yrs
2013-2014
|
2015+
|
||||||||||||||||
Obligations (1)
|
||||||||||||||||||||
Convertible
subordinated notes, including interest
|
$ | 234,167 | $ | 6,986 | $ | 227,181 | $ | — | $ | — | ||||||||||
Capital
leases, including interest
|
34,107 | 4,752 | 9,810 | 10,231 | 9,314 | |||||||||||||||
Operating
leases (2)
|
21,320 | — | — | 1,509 | 19,811 | |||||||||||||||
Purchase
commitments (3)
|
11,141 | 11,141 | — | — | — | |||||||||||||||
Litigation
settlement, including interest
|
7,000 | 1,000 | 2,000 | 2,000 | 2,000 | |||||||||||||||
$ | 307,735 | $ | 23,879 | $ | 238,991 | $ | 13,740 | $ | 31,125 |
(1)
|
The
above table does not include certain commitments and contingencies which
are discussed in Note 7 of Item 8. Financial Statements and Supplementary
Data.
|
48
(2)
|
On
September 30, 2009, we entered into an operating sublease for a new
facility which will include our corporate headquarters and an R&D
center at 455 Mission Bay Blvd in San Francisco,
California. The lease is discussed in Note 6 of Item 8.
Financial Statements and Supplementary Data.
|
(3)
|
Substantially
all of this amount was subject to open purchase orders as of December 31,
2009 that were issued under existing contracts. This amount does not
represent minimum contract termination liability for our existing
contracts.
|
Given our
current cash requirements, we forecast that we will have sufficient cash to meet
our net operating expense requirements and contractual obligations at least
through December 31, 2011. We plan to continue to invest in our growth and our
future cash requirements will depend upon the timing and results of these
investments. Our capital needs will depend on many factors, including continued
progress in our research and development programs, progress with preclinical and
clinical trials of our proprietary and partnered drug candidates, our ability to
successfully enter into additional collaboration agreements for one or more of
our proprietary drug candidates or intellectual property that we control, the
time and costs involved in obtaining regulatory approvals, the costs of
developing and scaling our clinical and commercial manufacturing operations, the
costs involved in preparing, filing, prosecuting, maintaining and enforcing
patent claims, the need to acquire licenses to new technologies and the status
of competitive products.
To date
we have incurred substantial debt as a result of our issuances of subordinated
notes that are convertible into our common stock. Our substantial debt, the
market price of our securities, and the general economic climate, among other
factors, could have material consequences for our financial condition and could
affect our sources of short-term and long-term funding. Our ability to meet our
ongoing operating expenses and repay our outstanding indebtedness is dependent
upon our and our partners’ ability to successfully complete clinical development
of, obtain regulatory approvals for and successfully commercialize new drugs.
Even if we or our partners are successful, we may require additional capital to
continue to fund our operations and repay our debt obligations as they become
due. There can be no assurance that additional funds, if and when required, will
be available to us on favorable terms, if at all.
Off
Balance Sheet Arrangements
We do not
utilize off-balance sheet financing arrangements as a source of liquidity or
financing.
Critical
Accounting Policies
The
preparation of financial statements in conformity with U.S. Generally Accepted
Accounting Principles (GAAP) requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period.
We base
our estimates on historical experience and on various other assumptions that we
believe to be reasonable under the circumstances, the results of which form our
basis for making judgments about the carrying value of assets and liabilities
that are not readily apparent from other sources, and evaluate our estimates on
an ongoing basis. Actual results may differ from those estimates under different
assumptions or conditions. We have determined that for the periods reported in
this report, the following accounting policies and estimates are critical in
understanding our financial condition and results of our
operations.
Revenue
Recognition
License,
collaboration and other research revenue includes amortization of upfront fees.
Upfront fees are recognized ratably over the expected performance period under
the arrangement. Management makes its best estimate of the period over which we
expect to fulfill our performance obligations, which may include technology
transfer assistance, clinical development activities, or manufacturing
activities through the commercial life of the product. Given the
complexities and uncertainties of research and development collaborations,
significant judgment is required to determine the duration of the performance
period.
As of
December 31, 2009, we have $51.8 million of deferred upfront fees related to
five research and collaboration agreements that are being amortized over 6 to 24
years, or an average of 12 years. For our research and collaboration
agreements, our performance obligations may span the life of the
agreement. For these, the shortest reasonable period is the end of
the development period (estimated to be 4 to 6 years) and the longest period is
the contractual life of the agreement, which is generally 10-12 years from the
first commercial sale. Given the statistical probability of drug
development success in the bio-pharmaceutical industry, drug development
programs have only a 5% to 10% probability of reaching commercial success. If we
had determined a longer or shorter amortization period was appropriate, our
annual upfront fee amortization could be as low as $4.0 million or as high as
$17.0 million.
49
As of
December 31, 2009, we also have $136.2 million of deferred upfront fees related
to three license agreements that are being amortized over 1.2, 2, and 6 years,
respectively. Our performance obligations for these agreements may
include technology transfer assistance and/or back-up manufacturing and supply
services for a specified period of time; therefore, the time estimated to
complete the performance obligations related to licenses is much shorter than
research and collaboration agreements. We may experience delays in
the execution of the technology transfer plans, which would result in a longer
amortization period.
Our
original estimates are periodically evaluated to determine if circumstances have
caused the estimates to change and if so, amortization of revenue is adjusted
prospectively.
Stock-Based
Compensation
We use
the Black-Scholes option valuation model adjusted for the estimated historical
forfeiture rate for the respective grant to determine the estimated fair value
of our stock-based compensation arrangements on the date of grant (grant date
fair value) and expense this value ratably over the service period of the option
or performance period of the Restricted Stock Unit award (RSU). The
Black-Scholes option pricing model requires the input of highly subjective
assumptions. Because our employee stock options have characteristics
significantly different from those of traded options, and because changes in the
subjective input assumptions can materially affect fair value estimates, in
management’s opinion, the existing models may not provide a reliable single
measure of the fair value of our employee stock options or common stock
purchased under our employee stock purchase plan. In addition, management
continually assesses the assumptions and methodologies used to calculate the
estimated fair value of stock-based compensation. Circumstances may change and
additional data may become available over time, which could result in changes to
the assumptions and methodologies, and which could materially impact our fair
value determination, as well as our stock-based compensation
expense.
Clinical
Trial Accruals
We record
accruals for the estimated costs of our clinical trials. Most of our clinical
trials are performed by third-party CROs, which are a significant component of
our Research and development expense. We accrue costs associated with the
start-up and reporting phases of the clinical trials ratably over the estimated
duration of the start-up and reporting phases. If the actual timing of these
phases varies from the estimate, we will adjust the accrual prospectively. We
accrue costs associated with treatment phase of clinical trials based on the
total estimated cost of the clinical trials and are expensed ratably based on
patient enrollment in the trials.
Recent
Accounting Pronouncements
FASB
Accounting Standards Update 2009-13, Revenue Recognition (Topic 605) –
Multiple-Deliverable Revenue Arrangements
In
October 2009, the FASB published FASB Accounting Standards Update (ASU) 2009-13,
which amends the criteria to identify separate units of accounting within
Subtopic 605-25, Revenue Recognition-Multiple-Element Arrangements. The revised
guidance also expands the disclosure required for multiple-element revenue
arrangements. FASB ASU No. 2009-13 is effective for fiscal years beginning on or
after June 15, 2010, and may be applied retrospectively for all periods
presented or prospectively to arrangements entered into or materially modified
after the adoption date. Early adoption is permitted provided that the revised
guidance is retroactively applied to the beginning of the year of adoption. We
are currently evaluating the impact of adoption on our financial position and
our results of operations.
FASB
ASU No. 2010-6, Improving Disclosures About Fair Value Measurements
In
January 2010, the FASB issued ASU No. 2010-6, Improving Disclosures About Fair
Value Measurements, that adds required disclosures about items
transferring into and out of Levels 1 and 2 in the fair value hierarchy; adding
separate disclosures about purchase, sales, issuances, and settlements relative
to Level 3 measurements; and clarifying, among other things, the existing fair
value disclosures about the level of disaggregation. FASB ASU No.
2010-6 is effective for interim and annual reporting periods beginning after
December 15, 2009, except for the requirement to provide level 3 purchases,
sales, issuances, and settlements on a gross basis, which is effective for
fiscal years beginning after December 15, 2010. Since this standard impacts
disclosure requirements only, we do not expect its adoption will have a material
impact on our financial statements.
50
Item 7A. Quantitative and Qualitative
Disclosures About Market Risk
Interest
Rate and Market Risk
The
primary objective of our investment activities is to preserve principal while at
the same time maximizing yields without significantly increasing risk. To
achieve this objective, we invest in liquid, high quality debt securities. Our
investments in debt securities are subject to interest rate risk. To minimize
the exposure due to an adverse shift in interest rates, we invest in short-term
securities and maintain a weighted average maturity of one year or
less.
A
hypothetical 50 basis point increase in interest rates would result in an
approximate $0.8 million decrease, less than 1%, in the fair value of our
available-for-sale securities at December 31, 2009. This potential change is
based on sensitivity analyses performed on our investment securities at December
31, 2009. Actual results may differ materially. The same hypothetical 50 basis
point increase in interest rates would have resulted in an approximate $0.4
million decrease, less than 1%, in the fair value of our available-for-sale
securities at December 31, 2008.
Due to
the adverse developments in the credit markets in 2009, we may experience
reduced liquidity with respect to some of our short-term investments. These
investments are generally held to maturity, which is less than one year.
However, if the need arose to liquidate such securities before maturity, we may
experience losses on liquidation. As of December 31, 2009, we held $363.1
million of available-for-sale investments, excluding money market funds, with an
average time to maturity of 153 days. To date we have not experienced any
liquidity issues with respect to these securities, but should such issues arise,
we may be required to hold some, or all, of these securities until maturity. We
believe that, even allowing for potential liquidity issues with respect to these
securities, our remaining cash and cash equivalents and short-term investments
will be sufficient to meet our anticipated cash needs for at least the next
twelve months. We have the ability and intent to hold our debt securities to
maturity when they will be redeemed at full par value. Accordingly, we consider
unrealized losses to be temporary and have not recorded a provision for
impairment.
Foreign
Currency Risk
The
majority of our revenue, expense, and capital purchasing activities are
transacted in U.S. dollars. However, since a portion of our operations consists
of research and development activities outside the United States, we have
entered into transactions in other currencies, primarily the Indian Rupee, and
we therefore are subject to foreign exchange risk.
Our
international operations are subject to risks typical of international
operations, including, but not limited to, differing economic conditions,
changes in political climate, differing tax structures, other regulations and
restrictions, and foreign exchange rate volatility. We do not utilize derivative
financial instruments to manage our exchange rate risks.
51
Item
8. Financial Statements and Supplementary Data
NEKTAR
THERAPEUTICS
INDEX
TO CONSOLIDATED FINANCIAL STATEMENTS
Page
|
|
Reports
of Independent Registered Public Accounting Firm
|
53
|
Consolidated
Balance Sheets at December 31, 2009 and 2008
|
55
|
Consolidated
Statements of Operations for each of the three years in the period ended
December 31, 2009
|
56
|
Consolidated
Statements of Stockholders’ Equity for each of the three years in the
period ended December 31, 2009
|
57
|
Consolidated
Statements of Cash Flows for each of the three years in the period ended
December 31, 2009
|
58
|
Notes
to Consolidated Financial Statements
|
59
|
52
Report
of Independent Registered Public Accounting Firm
The
Board of Directors and Stockholders of Nektar Therapeutics
We
have audited the accompanying consolidated balance sheets of Nektar
Therapeutics as of December 31, 2009 and 2008, and the related
consolidated statements of operations, stockholders' equity, and cash
flows for each of the three years in the period ended December 31, 2009.
Our audits also included the financial statement schedule listed in the
Index at Item 15(a)(2). These financial statements and schedule
are the responsibility of the Company's management. Our responsibility is
to express an opinion on these financial statements and schedule based on
our audits.
|
We
conducted our audits in accordance with the standards of the Public
Company Accounting Oversight Board (United States). Those standards
require that we plan and perform the audit to obtain reasonable assurance
about whether the financial statements are free of material misstatement.
An audit includes examining, on a test basis, evidence supporting the
amounts and disclosures in the financial statements. An audit also
includes assessing the accounting principles used and significant
estimates made by management, as well as evaluating the overall financial
statement presentation. We believe that our audits provide a reasonable
basis for our opinion.
|
In
our opinion, the financial statements referred to above present fairly, in
all material respects, the consolidated financial position of Nektar
Therapeutics at December 31, 2009 and 2008, and the consolidated results
of its operations and its cash flows for each of the three years in the
period ended December 31, 2009, in conformity with U.S. generally accepted
accounting principles. Also, in our opinion, the related
financial statement schedule, when considered in relation to the basic
financial statements taken as a whole, presents fairly in all material
respects the information set forth
therein.
|
We
also have audited, in accordance with the standards of the Public Company
Accounting Oversight Board (United States), Nektar Therapeutics’ internal
control over financial reporting as of December 31, 2009, based on
criteria established in Internal Control-Integrated Framework issued by
the Committee of Sponsoring Organizations of the Treadway Commission and
our report dated March 2, 2010, expressed an unqualified opinion
thereon.
|
/s/ Ernst
& Young LLP
Palo
Alto, CA
March 2,
2010
53
Report
of Independent Registered Public Accounting Firm
The
Board of Directors and Stockholders of Nektar Therapeutics
We have
audited Nektar Therapeutics’ internal control over financial reporting as of
December 31, 2009, based on criteria established in Internal
Control—Integrated Framework issued by the Committee of Sponsoring Organizations
of the Treadway Commission (the COSO criteria). Nektar Therapeutics’ management
is responsible for maintaining effective internal control over financial
reporting, and for its assessment of the effectiveness of internal control over
financial reporting included in the accompanying Management’s Annual Report on
Internal Control over Financial Reporting. Our responsibility is to express an
opinion on the company’s internal control over financial reporting based on our
audit.
We
conducted our audit in accordance with the standards of the Public Company
Accounting Oversight Board (United States). Those standards require that we plan
and perform the audit to obtain reasonable assurance about whether effective
internal control over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of internal control over
financial reporting, assessing the risk that a material weakness exists, testing
and evaluating the design and operating effectiveness of internal control based
on the assessed risk, and performing such other procedures as we considered
necessary in the circumstances. We believe that our audit provides a reasonable
basis for our opinion.
A
company’s internal control over financial reporting is a process designed to
provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with generally accepted accounting principles. A company’s internal control over
financial reporting includes those policies and procedures that (1) pertain
to the maintenance of records that, in reasonable detail, accurately and fairly
reflect the transactions and dispositions of the assets of the company;
(2) provide reasonable assurance that transactions are recorded as
necessary to permit preparation of financial statements in accordance with
generally accepted accounting principles, and that receipts and expenditures of
the company are being made only in accordance with authorizations of management
and directors of the company; and (3) provide reasonable assurance
regarding prevention or timely detection of unauthorized acquisition, use or
disposition of the company’s assets that could have a material effect on the
financial statements.
Because
of its inherent limitations, internal control over financial reporting may not
prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become
inadequate because of changes in conditions, or that the degree of compliance
with the policies or procedures may deteriorate.
In our
opinion, Nektar Therapeutics maintained, in all material respects, effective
internal control over financial reporting as of December 31, 2009, based on
the COSO criteria.
We also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the consolidated balance sheets of Nektar
Therapeutics as of December 31, 2009 and 2008, and the related consolidated
statements of operations, stockholders’ equity and cash flows for each
of the three years in the period ended December 31, 2009 of Nektar
Therapeutics and our report dated March 2, 2010 expressed an unqualified opinion
thereon.
/s/ Ernst
& Young LLP
Palo
Alto, CA
March 2,
2010
54
NEKTAR
THERAPEUTICS
CONSOLIDATED
BALANCE SHEETS
(In
thousands, except per share information)
December 31,
|
||||||||
2009
|
2008
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 49,597 | $ | 155,584 | ||||
Short-term
investments
|
346,614 | 223,410 | ||||||
Accounts
receivable, net of allowance of nil and $92 at December 31, 2009 and 2008,
respectively
|
4,801 | 11,161 | ||||||
Inventory
|
6,471 | 9,319 | ||||||
Other
current assets
|
6,183 | 6,746 | ||||||
Total
current assets
|
$ | 413,666 | $ | 406,220 | ||||
Property
and equipment, net
|
78,263 | 73,578 | ||||||
Goodwill
|
76,501 | 76,501 | ||||||
Other
assets
|
7,088 | 4,237 | ||||||
Total
assets
|
$ | 575,518 | $ | 560,536 | ||||
LIABILITIES
AND STOCKHOLDERS’ EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 3,066 | $ | 13,832 | ||||
Accrued
compensation
|
10,052 | 11,570 | ||||||
Accrued
clinical trial expenses
|
14,167 | 17,622 | ||||||
Accrued
expenses
|
4,354 | 9,923 | ||||||
Deferred
revenue, current portion
|
115,563 | 10,010 | ||||||
Other
current liabilities
|
5,814 | 5,417 | ||||||
Total
current liabilities
|
$ | 153,016 | $ | 68,374 | ||||
Convertible
subordinated notes
|
214,955 | 214,955 | ||||||
Capital
lease obligations, less current portion
|
18,800 | 20,347 | ||||||
Deferred
revenue, less current portion
|
76,809 | 55,567 | ||||||
Deferred
gain
|
5,027 | 5,901 | ||||||
Other
long-term liabilities
|
4,544 | 5,238 | ||||||
Total
liabilities
|
$ | 473,151 | $ | 370,382 | ||||
Commitments
and contingencies
|
||||||||
Stockholders’
equity:
|
||||||||
Preferred
stock, 10,000 shares authorized Series A, $0.0001 par value; 3,100 shares
designated; no shares issued or outstanding at either December 31, 2009 or
2008
|
— | — | ||||||
Common
stock, $0.0001 par value; 300,000 authorized; 93,281 shares and 92,503
shares issued and outstanding at December 31, 2009 and 2008,
respectively
|
9 | 9 | ||||||
Capital
in excess of par value
|
1,327,942 | 1,312,796 | ||||||
Accumulated
other comprehensive income
|
1,025 | 1,439 | ||||||
Accumulated
deficit
|
(1,226,609 | ) | (1,124,090 | ) | ||||
Total
stockholders’ equity
|
102,367 | 190,154 | ||||||
Total
liabilities and stockholders’ equity
|
$ | 575,518 | $ | 560,536 |
The accompanying notes are an
integral part of these consolidated financial statements.
55
NEKTAR
THERAPEUTICS
CONSOLIDATED
STATEMENTS OF OPERATIONS
(in
thousands, except per share information)
Years ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Revenue:
|
||||||||||||
Product
sales and royalties
|
$ | 35,288 | $ | 41,255 | $ | 180,755 | ||||||
License,
collaboration and other revenue
|
36,643 | 48,930 | 92,272 | |||||||||
Total
revenue
|
$ | 71,931 | $ | 90,185 | $ | 273,027 | ||||||
Operating
costs and expenses:
|
||||||||||||
Cost
of goods sold
|
30,948 | 28,216 | 137,696 | |||||||||
Other
cost of revenue
|
— | 6,821 | 9,821 | |||||||||
Research
and development
|
95,109 | 154,417 | 153,575 | |||||||||
General
and administrative
|
41,006 | 51,497 | 58,865 | |||||||||
Impairment
of long-lived assets
|
— | 1,458 | 28,396 | |||||||||
Gain
on sale of pulmonary assets
|
— | (69,572 | ) | — | ||||||||
Gain
on termination of collaborative agreements, net
|
— | — | (79,178 | ) | ||||||||
Total
operating costs and expenses
|
$ | 167,063 | $ | 172,837 | $ | 309,175 | ||||||
Loss
from operations
|
(95,132 | ) | (82,652 | ) | (36,148 | ) | ||||||
Non-operating
income (expense):
|
||||||||||||
Interest
income
|
3,688 | 12,495 | 22,201 | |||||||||
Interest
expense
|
(12,176 | ) | (15,192 | ) | (18,638 | ) | ||||||
Other
income (expense), net
|
848 | 58 | 1,133 | |||||||||
Gain
on extinguishment of debt
|
— | 50,149 | — | |||||||||
Total
non-operating income (expense), net
|
(7,640 | ) | 47,510 | 4,696 | ||||||||
Loss
before (benefit) provision for income taxes
|
$ | (102,772 | ) | $ | (35,142 | ) | $ | (31,452 | ) | |||
(Benefit)
provision for income taxes
|
(253 | ) | (806 | ) | 1,309 | |||||||
Net
loss
|
$ | (102,519 | ) | $ | (34,336 | ) | $ | (32,761 | ) | |||
Basic
and diluted net loss per share
|
$ | (1.11 | ) | $ | (0.37 | ) | $ | (0.36 | ) | |||
Shares
used in computing basic and diluted net loss per share
|
92,772 | 92,407 | 91,876 |
The accompanying notes are an
integral part of these consolidated financial statements.
56
NEKTAR
THERAPEUTICS
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY
(in
thousands)
Common
Shares
|
Par Value
|
Capital In
Excess of
Par Value
|
Accumulated Other
Comprehensive
Income/(Loss)
|
Accumulated
Deficit
|
Total
Stockholders’
Equity
|
|||||||||||||||||||
Balance at December 31, 2006
|
91,280 | $ | 9 | $ | 1,283,982 | $ | 62 | $ | (1,056,993 | ) | $ | 227,060 | ||||||||||||
Stock
option exercises and RSU release
|
761 | — | 2,915 | — | — | 2,915 | ||||||||||||||||||
Stock-based
compensation
|
— | — | 13,193 | — | — | 13,193 | ||||||||||||||||||
Shares
issued for employee plans(1)
|
260 | — | 2,451 | — | — | 2,451 | ||||||||||||||||||
Other
comprehensive income
|
— | — | — | 1,581 | — | 1,581 | ||||||||||||||||||
Net
loss
|
— | — | — | — | (32,761 | ) | (32,761 | ) | ||||||||||||||||
Comprehensive
loss
|
(31,180 | ) | ||||||||||||||||||||||
Balance
at December 31, 2007
|
92,301 | $ | 9 | $ | 1,302,541 | $ | 1,643 | $ | (1,089,754 | ) | $ | 214,439 | ||||||||||||
Stock
option exercises and RSU release
|
146 | — | 122 | — | — | 122 | ||||||||||||||||||
Stock-based
compensation
|
— | — | 9,871 | — | — | 9,871 | ||||||||||||||||||
Shares
issued for Employee Stock Purchase Plan
|
56 | — | 262 | — | — | 262 | ||||||||||||||||||
Other
comprehensive loss
|
— | — | — | (204 | ) | — | (204 | ) | ||||||||||||||||
Net
loss
|
— | — | — | — | (34,336 | ) | (34,336 | ) | ||||||||||||||||
Comprehensive
loss
|
(34,540 | ) | ||||||||||||||||||||||
Balance
at December 31, 2008
|
92,503 | $ | 9 | $ | 1,312,796 | $ | 1,439 | $ | (1,124,090 | ) | $ | 190,154 | ||||||||||||
Stock
option exercises and RSU release
|
742 | — | 4,696 | — | — | 4,696 | ||||||||||||||||||
Stock-based
compensation
|
— | — | 10,326 | — | — | 10,326 | ||||||||||||||||||
Shares
issued for Employee Stock Purchase Plan
|
36 | — | 124 | — | — | 124 | ||||||||||||||||||
Other
comprehensive loss
|
— | — | — | (414 | ) | — | (414 | ) | ||||||||||||||||
Net
loss
|
— | — | — | — | (102,519 | ) | (102,519 | ) | ||||||||||||||||
Comprehensive
loss
|
(102,933 | ) | ||||||||||||||||||||||
Balance
at December 31, 2009
|
93,281 | $ | 9 | $ | 1,327,942 | $ | 1,025 | $ | (1,226,609 | ) | $ | 102,367 |
(1)
|
Employee
plans include our Employee Stock Purchase and 401K
Plans
|
The accompanying notes are an
integral part of these consolidated financial statements.
57
NEKTAR
THERAPEUTICS
CONSOLIDATED
STATEMENTS OF CASH FLOWS
(in
thousands)
Years ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (102,519 | ) | $ | (34,336 | ) | $ | (32,761 | ) | |||
Adjustments
to reconcile net loss to net cash provided by (used in) operating
activities:
|
||||||||||||
Depreciation
and amortization
|
14,881 | 22,489 | 29,028 | |||||||||
Stock-based
compensation
|
10,326 | 9,871 | 14,779 | |||||||||
Other
non-cash transactions
|
(657 | ) | 1,251 | 109 | ||||||||
Gain
on sale of pulmonary assets
|
— | (69,572 | ) | — | ||||||||
Gain
on extinguishment of debt
|
— | (50,149 | ) | — | ||||||||
Impairment
of long-lived assets
|
— | 1,458 | 28,396 | |||||||||
Changes
in assets and liabilities:
|
||||||||||||
Decrease
(increase) in trade accounts receivable
|
6,034 | 10,476 | 24,318 | |||||||||
Decrease
(increase) in inventory
|
2,848 | 2,868 | 1,503 | |||||||||
Decrease
(increase) in other assets
|
(200 | ) | 1,166 | 7,443 | ||||||||
Increase
(decrease) in accounts payable
|
(8,046 | ) | 6,181 | (3,147 | ) | |||||||
Increase
(decrease) in accrued compensation
|
(1,518 | ) | (3,382 | ) | 986 | |||||||
Increase
(decrease) in accrued clinical trial expenses
|
(3,455 | ) | 14,727 | 907 | ||||||||
Increase
(decrease) in accrued expenses to contract manufacturers
|
— | (40,444 | ) | 40,444 | ||||||||
Increase
(decrease) in accrued expenses
|
(4,191 | ) | (1,332 | ) | (5,200 | ) | ||||||
Increase
(decrease) in deferred revenue
|
126,795 | (15,392 | ) | 40,863 | ||||||||
Increase
(decrease) in other liabilities
|
(559 | ) | (1,662 | ) | (1,366 | ) | ||||||
Net
cash provided by (used in) operating activities
|
$ | 39,739 | $ | (145,782 | ) | $ | 146,302 | |||||
Cash
flows from investing activities:
|
||||||||||||
Purchases
of property and equipment
|
(16,390 | ) | (18,855 | ) | (32,796 | ) | ||||||
Advance
payments for property and equipment
|
(4,312 | ) | — | — | ||||||||
Maturities
of investments
|
310,707 | 588,168 | 591,202 | |||||||||
Sales
of investments
|
17,318 | 70,060 | 2,057 | |||||||||
Purchases
of investments
|
(451,918 | ) | (475,316 | ) | (593,118 | ) | ||||||
Proceeds
from sale of pulmonary assets
|
(4,440 | ) | 114,831 | — | ||||||||
Investment
in Pearl Therapeutics
|
— | (4,236 | ) | — | ||||||||
Net
cash provided by (used in) investing activities
|
$ | (149,035 | ) | $ | 274,652 | $ | (32,655 | ) | ||||
Cash
flows from financing activities:
|
||||||||||||
Issuance
of common stock, net of issuance costs
|
4,820 | 384 | 3,780 | |||||||||
Payments
of loan and capital lease obligations
|
(1,285 | ) | (2,368 | ) | (2,895 | ) | ||||||
Repayments
of convertible subordinated notes
|
— | (47,757 | ) | (102,653 | ) | |||||||
Net
cash provided by (used in) financing activities
|
$ | 3,535 | $ | (49,741 | ) | $ | (101,768 | ) | ||||
Effect
of exchange rates on cash and cash equivalents
|
(226 | ) | 162 | 654 | ||||||||
Net
(decrease) increase in cash and cash equivalents
|
$ | (105,987 | ) | $ | 79,291 | $ | 12,533 | |||||
Cash
and cash equivalents at beginning of year
|
155,584 | 76,293 | 63,760 | |||||||||
Cash
and cash equivalents at end of year
|
$ | 49,597 | $ | 155,584 | $ | 76,293 | ||||||
Supplemental
disclosure of cash flows information:
|
||||||||||||
Cash
paid for interest
|
$ | 11,225 | $ | 14,702 | $ | 17,389 | ||||||
Cash
paid for income taxes
|
$ | 743 | $ | 812 | $ | 801 | ||||||
Supplemental
schedule of non-cash investing and financing activities:
|
||||||||||||
Property
acquired through capital leases
|
$ | — | $ | — | $ | 4,445 |
The accompanying notes are an
integral part of these consolidated financial statements.
58
NEKTAR
THERAPEUTICS
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
December
31, 2009
Note 1—Organization and Summary of
Significant Accounting Policies
Organization
We are a
clinical-stage biopharmaceutical company headquartered in San Carlos, California
and incorporated in Delaware. We are developing a pipeline of drug candidates
that utilize our PEGylation and advanced polymer conjugate technology platforms
designed to improve the therapeutic benefits of drugs.
Basis
of Presentation, Principles of Consolidation and Use of Estimates
Our
consolidated financial statements include the financial position, results of
operations and cash flows of our wholly-owned subsidiaries: Nektar Therapeutics
AL, Corporation (Nektar AL), Nektar Therapeutics (India) Private Limited, Nektar
Therapeutics UK, Ltd. (Nektar UK) and Aerogen, Inc. All intercompany accounts
and transactions have been eliminated in consolidation. The merger of Nektar AL,
an Alabama corporation, with and into its parent corporation, Nektar
Therapeutics, was made effective July 31, 2009. As of the effective date, the
separate existence of the Alabama corporation ceased, and all rights,
privileges, powers and franchises of the Alabama corporation are vested in
Nektar Therapeutics, the surviving corporation.
Our
consolidated financial statements are denominated in U.S. dollars. Accordingly,
changes in exchange rates between the applicable foreign currency and the U.S.
dollar will affect the translation of each foreign subsidiary’s financial
results into U.S. dollars for purposes of reporting our consolidated financial
results. Translation gains and losses are included in accumulated other
comprehensive loss in the stockholders’ equity section of the balance sheet. To
date, such cumulative translation adjustments have not been material to our
consolidated financial position. Aggregate gross foreign currency
transaction gains (losses) recorded in operations for the years ended December
31, 2009, 2008, and 2007 were not material.
The
preparation of financial statements in conformity with U.S. generally accepted
accounting principles (GAAP) requires management to make estimates and
assumptions that affect the reported amounts of assets and liabilities and
disclosure of contingent assets and liabilities at the date of the financial
statements and the reported amounts of revenues and expenses during the
reporting period. Actual results could differ from those estimates. On an
ongoing basis, we evaluate our estimates, including those related to deferred
revenue amortization periods, inventories and related impairment of investments
and long-lived assets, restructuring and contingencies, stock-based
compensation, and litigation, amongst others. We base our estimates on
historical experience and on other assumptions that management believes are
reasonable under the circumstances. These estimates form the basis for making
judgments about the carrying values of assets and liabilities when these values
are not readily apparent from other sources. Certain items previously reported
in specific financial statement captions have been reclassified to conform to
the current period presentation. Such reclassifications have not impacted
previously reported revenues, operating loss or net loss.
Cash,
Cash Equivalents, and Investments and Fair Value of Financial
Instruments
We
consider all investments in marketable securities with an original maturity of
three months or less to be cash equivalents. Investments are designated as
available-for-sale and are carried at fair value, with unrealized gains and
losses reported in stockholders’ equity as accumulated other comprehensive
income (loss). The disclosed fair value related to our investments is based
primarily on the reported fair values in our period-end brokerage statements. We
independently validate these fair values using available market quotes and other
information. Investments with maturities greater than one year from the balance
sheet date, if any, are classified as long-term.
Interest
and dividends on securities classified as available-for-sale, as well as
amortization of premiums and accretion of discounts to maturity, are included in
interest income. Realized gains and losses and declines in value of
available-for-sale securities judged to be other-than-temporary, if any, are
included in other income (expense). The cost of securities sold is based on the
specific identification method.
59
The
carrying value of cash, cash equivalents, and investments approximates fair
value and is based on quoted market prices.
Accounts
Receivable and Significant Customer Concentrations
Our
customers are primarily pharmaceutical and biotechnology companies that are
located in the U.S. and Europe. Our accounts receivable balance contains billed
and unbilled trade receivables from product sales and royalties and
collaborative research agreements. We provide for an allowance for doubtful
accounts by reserving for specifically identified doubtful accounts. We
generally do not require collateral from our customers. We perform a regular
review of our customers’ payment histories and associated credit risk. We have
not experienced significant credit losses from our accounts receivable. At
December 31, 2009, four different customers represented 30%, 29%, 13%, and 13%,
respectively, of our accounts receivable. At December 31, 2008, three
different customers represented 29%, 19%, and 15%, respectively, of our accounts
receivable.
Inventories
and Significant Supplier Concentrations
Inventories
are computed on a first-in, first-out basis and stated net of reserves at the
lower of cost or market. Inventory costs include direct materials, direct labor,
and manufacturing overhead. Supplies inventory related to research and
development activities are expensed when purchased.
We are
dependent on our partners and vendors to provide raw materials, drugs and
devices of appropriate quality and reliability and to meet applicable regulatory
requirements. Consequently, in the event that supplies are delayed or
interrupted for any reason, our ability to develop and produce our products
could be impaired, which could have a material adverse effect on our business,
financial condition and results of operation.
Property
and Equipment
Property
and equipment are stated at cost. Major improvements are capitalized, while
maintenance and repairs are expensed when incurred. Manufacturing, laboratory
and other equipment are depreciated using the straight-line method generally
over estimated useful lives of three to seven years. Leasehold improvements and
buildings are depreciated using the straight-line method over the shorter of the
estimated useful life or the remaining term of the lease.
We
periodically review our property and equipment for recoverability whenever
events or changes in circumstances indicate that the carrying value may not be
recoverable. Generally, an impairment loss would be recognized if the carrying
amount of an asset exceeds the sum of the discounted cash flows expected to
result from the use and eventual disposal of the asset (See Note
12).
Goodwill
Goodwill
represents the excess of the price paid for another entity over the fair value
of the assets acquired and liabilities assumed in a business combination. We
test for impairment in the fourth quarter of each year using an October 1
measurement date, as well as at other times when impairment indicators exist or
when events occur or circumstances change that would indicate the carrying
amount may not be fully recoverable.
We are
organized in one reporting unit and have evaluated the goodwill for the Company
as a whole. Goodwill is tested for impairment using a two-step
approach. The first step is to compare the fair value of our net assets,
including assigned goodwill, to the book value of our net assets, including
assigned goodwill. If the fair value is greater than our net book value, the
assigned goodwill is not considered impaired. If the fair value is less than our
net book value, we perform a second step to measure the amount of the
impairment, if any. The second step would be to compare the book value of our
assigned goodwill to the implied fair value of our goodwill. As of December 31,
2009 and 2008, the carrying value of our goodwill was $76.5 million. We did not
recognize any goodwill-related impairment charges during 2009, 2008 or
2007.
Revenue
Recognition
Product
sales and royalties
Product
sales are primarily derived from cost-plus manufacturing and supply agreements
with our collaboration partners and revenue is recognized in accordance with the
terms of the related agreement. We have not experienced any significant returns
from our customers.
60
Generally,
we are entitled to royalties from our partners based on their net sales once
their products are approved for commercial sale. We recognize royalty revenue
when the cash is received or when the royalty amount to be received is estimable
and collection is reasonably assured.
License,
collaboration and other
We enter
into technology license agreements and collaborative research and development
arrangements with pharmaceutical and biotechnology partners that may involve
multiple deliverables. Our arrangements may contain one or more of the following
elements: upfront fees, contract research, milestone payments, manufacturing and
supply, royalties, and license fees. Each deliverable in the arrangement is
evaluated to determine whether it meets the criteria to be accounted for as a
separate unit of accounting or whether it should be combined with other
deliverables. Revenue is recognized for each element when there is
persuasive evidence that an arrangement exists, delivery has occurred, the price
is fixed or determinable, and collection is reasonably assured.
Upfront
fees received for license and collaborative agreements are recognized ratably
over our expected performance period under the
arrangement. Management makes its best estimate of the period over
which we expect to fulfill our performance obligations, which may include
technology transfer assistance, clinical development activities, and
manufacturing activities from development through the commercialization of the
product. Given the uncertainties of research and development
collaborations, significant judgment is required to determine the duration of
the performance period.
Performance
milestones payments received are deferred and recorded as revenue ratably over
the period of time from the achievement of the milestone and our estimated date
on which the next milestone will be achieved. Management makes its
best estimate of the period of time until the next milestone is
reached. Final milestone payments are recorded and recognized upon
achieving the respective milestone, provided that collection is reasonably
assured.
The
original estimated amortization periods for upfront fees and milestone payments
are periodically evaluated to determine if circumstances have caused the
estimate to change and if so, amortization of revenue is adjusted
prospectively.
Shipping
and Handling Costs
We record
costs related to shipping and handling of product to customers in cost of goods
sold.
Stock-Based
Compensation
Stock-based
compensation arrangements include stock option grants and restricted stock unit
(RSU) awards under our equity incentive plans and our Employee Stock Purchase
Plan (ESPP), in which employees may purchase our common stock at a discount to
the market price.
We use
the Black-Scholes option valuation model, adjusted for the estimated historical
forfeiture rate, for the respective grant to determine the estimated fair value
of the option or RSU award on the date of grant (grant date fair value) and the
estimated fair value of common stock purchased under the ESPP. The
Black-Scholes option pricing model requires the input of highly subjective
assumptions. Because our employee stock options have characteristics
significantly different from those of traded options, and because changes in the
subjective input assumptions can materially affect the fair value estimate, in
management’s opinion, the existing models may not provide a reliable single
measure of the fair value of our employee stock options or common stock
purchased under the ESPP. Management will continue to assess the assumptions and
methodologies used to calculate estimated fair value of stock-based
compensation. Circumstances may change and additional data may become available
over time, which could result in changes to these assumptions and methodologies,
and which could materially impact our fair value determination.
We
expense the value of the portion of the option or award that is ultimately
expected to vest on a straight line basis over the requisite service periods in
our Consolidated Statements of Operations. Stock-based compensation expense for
purchases under the ESPP are recognized based on the estimated fair value of the
common stock during each offering period and the percentage of the purchase
discount. Expense amounts are allocated among inventory, cost of
goods sold, research and development expenses, and general and administrative
expenses based on the function of the applicable employee.
Research
and Development Expense
Research
and development costs are expensed as incurred and include salaries, benefits
and other operating costs such as outside services, supplies and allocated
overhead costs. We perform research and development for our proprietary drug
candidates and technology development and for certain third parties under
collaboration agreements. For our proprietary drug candidates and our internal
technology development programs, we invest our own funds without reimbursement
from a third party. Costs associated with treatment phase of clinical trials are
accrued based on the total estimated cost of the clinical trials and are
expensed ratably based on patient enrollment in the trials. Costs associated
with the start-up and reporting phases of the clinical trials are expensed
ratably over the duration of the reporting and start-up phases.
61
Net
Loss Per Share
Basic net
loss per share is calculated based on the weighted-average number of common
shares outstanding during the periods presented. For all periods presented in
the Consolidated Statements of Operations, the net loss available to common
stockholders is equal to the reported net loss. Basic and diluted net loss per
share are the same due to our historical net losses and the requirement to
exclude potentially dilutive securities which would have an anti-dilutive effect
on net loss per share. The weighted average of these potentially dilutive
securities has been excluded from the diluted net loss per share calculation and
is as follows (in thousands):
Years ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Convertible
subordinated notes
|
9,989 | 13,804 | 15,781 | |||||||||
Stock
options
|
10,653 | 14,147 | 11,108 | |||||||||
Total
|
20,642 | 27,951 | 26,889 |
Income
Taxes
We
account for income taxes under the liability method; under this method, deferred
tax assets and liabilities are determined based on differences between financial
reporting and tax reporting bases of assets and liabilities and are measured
using enacted tax rates and laws that are expected to be in effect when the
differences are expected to reverse. Realization of deferred tax assets is
dependent upon future earnings, the timing and amount of which are
uncertain.
We
utilize a two-step approach to recognize and measure uncertain tax positions.
The first step is to evaluate the tax position for recognition by determining if
the weight of available evidence indicates that it is more likely than not that
the position will be sustained upon tax authority examination, including
resolution of related appeals or litigation processes, if any. The second step
is to measure the tax benefit as the largest amount that is more than 50% likely
of being realized upon ultimate settlement.
We have
incurred net operating losses since inception and we do not have any significant
unrecognized tax benefits. Our policy is to include interest and penalties
related to unrecognized tax benefits, if any, within the provision for taxes in
the consolidated statements of operations. If we are eventually able to
recognize our uncertain positions, our effective tax rate may be reduced. We
currently have a full valuation allowance against our net deferred tax asset
which would impact the timing of the effective tax rate benefit should any of
these uncertain tax positions be favorably settled in the future. Any
adjustments to our uncertain tax positions would result in an adjustment of our
net operating loss or tax credit carry forwards rather than resulting in a cash
outlay.
We file
income tax returns in the U.S., California, Alabama, India and the U.K. We are
currently not the subject of any income tax examinations. In general, the
earliest open year subject to examination is 2006 for U.S. and Alabama and 2005
for California, although depending upon the jurisdiction tax years may remain
open, subject to certain limitations.
Recent
Accounting Pronouncements
FASB
Accounting Standards Update 2009-13, Revenue Recognition (Topic 605) –
Multiple-Deliverable Revenue Arrangements
In
October 2009, the FASB published FASB Accounting Standards Update (ASU) 2009-13,
which amends the criteria to identify separate units of accounting within
Subtopic 605-25, Revenue Recognition-Multiple-Element Arrangements. The revised
guidance also expands the disclosure required for multiple-element revenue
arrangements. FASB ASU No. 2009-13 is effective for fiscal years beginning on or
after June 15, 2010, and may be applied retrospectively for all periods
presented or prospectively to arrangements entered into or materially modified
after the adoption date. Early adoption is permitted provided that the revised
guidance is retroactively applied to the beginning of the year of adoption. We
are currently evaluating the impact of adoption on our financial position and
results of operations.
62
FASB
ASU No. 2010-6, Improving Disclosures About Fair Value Measurements
In
January 2010, the FASB issued ASU No. 2010-6, Improving Disclosures About Fair
Value Measurements, that adds required disclosures about items
transferring into and out of Levels 1 and 2 in the fair value hierarchy; adding
separate disclosures about purchase, sales, issuances, and settlements relative
to Level 3 measurements; and clarifying, among other things, the existing fair
value disclosures about the level of disaggregation. FASB ASU No.
2010-6 is effective for interim and annual reporting periods beginning after
December 15, 2009, except for the requirement to provide level 3 purchases,
sales, issuances, and settlements on a gross basis, which is effective for
fiscal years beginning after December 15, 2010. Since this standard impacts
disclosure requirements only, we do not expect its adoption will have a material
impact on our financial statements.
Note 2—Cash, Cash Equivalents, and
Available-For-Sale Investments
Cash,
cash equivalents, and available-for-sale investments are as follows (in
thousands):
Estimated Fair Value at
|
||||||||
December 31, 2009
|
December 31, 2008
|
|||||||
Cash
and cash equivalents
|
$ | 49,597 | $ | 155,584 | ||||
Short-term
investments (less than one year to maturity)
|
346,614 | 223,410 | ||||||
Total
cash, cash equivalents, and available-for-sale investments
|
$ | 396,211 | $ | 378,994 |
Our
portfolio of cash, cash equivalents, and available-for-sale investments includes
(in thousands):
Estimated Fair Value at
|
||||||||
December 31, 2009
|
December 31, 2008
|
|||||||
Obligations
of U.S. corporations
|
$ | 160,458 | $ | 26,275 | ||||
Obligations
of U.S. government agencies
|
125,731 | 91,667 | ||||||
U.S.
corporate commercial paper
|
71,923 | 115,658 | ||||||
Obligations
of U.S. states and municipalities
|
4,995 | — | ||||||
Cash
and money market funds
|
33,104 | 145,394 | ||||||
Total
cash, cash equivalents, and available-for-sale investments
|
$ | 396,211 | $ | 378,994 |
The
primary objective of our investment activities is to preserve principal while at
the same time maximizing yields without significantly increasing risk. To
achieve this objective, we invest in liquid, high quality debt securities. Our
investments in debt securities are subject to interest rate risk. To minimize
the exposure due to an adverse shift in interest rates, we invest in short-term
securities and maintain a weighted average maturity of one year or less. At
December 31, 2009, the average portfolio duration was approximately five months
and the contractual maturity of any single investment did not exceed twelve
months. At December 31, 2008, the average portfolio duration was
approximately two months and the contractual maturity of any single investment
did not exceed twelve months.
Gross
unrealized gains and losses were insignificant at December 31, 2009 and at
December 31, 2008. The gross unrealized losses were primarily due to changes in
interest rates on fixed income securities. Based on our available cash and our
expected operating cash requirements we do not intend to sell these securities
and it is more likely than not that we will not be required to sell these
securities before we recover the amortized cost basis. Accordingly, we believe
there are no other-than-temporary impairments on these securities and have not
recorded a provision for impairment.
During
the years ended December 31, 2009 and 2008, we sold available-for-sale
securities totaling $17.3 million and $70.1 million, respectively. We realized
gains in the income statement of $0.1 million and $0.1 million in 2009 and 2008,
respectively. In 2009, we sold securities in response to a
tender offer from a bond issuer and we sold securities which no longer met the
minimum credit rating required by our investment policy. During 2008
we sold securities to fund our convertible subordinated note
repurchase.
At
December 31, 2009 and 2008, we had letter of credit arrangements with certain
financial institutions and vendors, including our landlord, totaling $2.9
million. These letters of credit are secured by investments of similar
amounts.
63
The
following table represents the fair value hierarchy for our financial assets
measured at fair value on a recurring basis as of December 31, 2009 (in
thousands):
Level 1
|
Level 2
|
Level 3
|
Total
|
|||||||||||||
Money
market funds
|
$ | 24,585 | $ | — | $ | — | $ | 24,585 | ||||||||
U.S.
corporate commercial paper
|
— | 71,923 | — | 71,923 | ||||||||||||
Obligations
of U.S. corporations
|
— | 160,458 | — | 160,458 | ||||||||||||
Obligations
of U.S. government agencies
|
— | 125,731 | — | 125,731 | ||||||||||||
Obligations
of U.S. states and municipalities
|
— | 4,995 | — | 4,995 | ||||||||||||
Cash
equivalents and available-for-sale investments
|
$ | 24,585 | $ | 363,107 | $ | — | $ | 387,692 | ||||||||
Cash
|
8,519 | |||||||||||||||
Cash,
cash equivalents, and available-for-sale investments
|
$ | 396,211 |
Level1—
|
Quoted
prices in active markets for identical assets or
liabilities.
|
Level2—
|
Inputs
other than Level 1 that are observable, either directly or indirectly,
such as quoted prices for similar assets or liabilities; quoted prices in
markets that are not active; or other inputs that are observable or can be
corroborated by observable market data for substantially the full term of
the assets or liabilities.
|
Level3—
|
Unobservable
inputs that are supported by little or no market activity and that are
significant to the fair value of the assets or
liabilities.
|
Note
3 - Inventory
Inventory
consists of the following (in thousands):
December 31,
|
||||||||
2009
|
2008
|
|||||||
Raw
materials
|
$ | 5,937 | $ | 6,964 | ||||
Work-in-process
|
— | 1,743 | ||||||
Finished
goods
|
534 | 612 | ||||||
Inventory
|
$ | 6,471 | $ | 9,319 |
Inventory
is manufactured upon receipt of firm purchase orders from our licensing
partners. Inventory includes direct materials, direct labor, and
manufacturing overhead and is computed on a first-in, first-out basis. Inventory
is stated at the lower of cost or market and is net of reserves of $3.3 million
and $5.0 million as of December 31, 2009 and December 31, 2008, respectively.
Reserves are determined using specific identification plus an estimated reserve
for potential defective or excess inventory based on historical experience or
projected usage.
Note
4—Property and Equipment
Property
and equipment consist of the following (in thousands):
December 31,
|
||||||||
2009
|
2008
|
|||||||
Building
and leasehold improvements
|
$ | 62,973 | $ | 62,260 | ||||
Laboratory
equipment
|
27,195 | 24,549 | ||||||
Manufacturing
equipment
|
10,982 | 8,682 | ||||||
Furniture,
fixtures and other equipment
|
16,876 | 14,717 | ||||||
Depreciable
Property and equipment at cost
|
$ | 118,026 | $ | 110,208 | ||||
Less:
accumulated depreciation
|
(54,400 | ) | (43,505 | ) | ||||
Depreciable
Property and equipment, net
|
63,626 | 66,703 | ||||||
Construction-in-progress
|
14,637 | 6,875 | ||||||
Property
and equipment, net
|
$ | 78,263 | $ | 73,578 |
64
Building
and leasehold improvements include our commercial manufacturing, clinical
manufacturing, research and development and administrative facilities and the
related improvements to these facilities. Laboratory and manufacturing equipment
includes assets that support both our manufacturing and research and development
efforts. Construction-in-progress includes assets being built to enhance our
manufacturing and research and development programs. Property and equipment
includes assets acquired through capital leases (See Note 6). During
2009, we made advanced payments of $4.3 million for equipment that had not been
received by December 31, 2009; these advances were classified as Other Assets on
our Consolidated Balance Sheets.
Depreciation
expense, including depreciation of assets acquired through capital leases, for
the years ended December 31, 2009, 2008, and 2007 was $12.7 million, $19.8
million, and $25.9 million, respectively.
On
December 31, 2008, we sold certain assets and obligations related to our
pulmonary technology, development and manufacturing operations to Novartis
Pharmaceuticals Corporation and Novartis Pharma AG (together referred to as
Novartis), including property and equipment with a gross book value of $108.0
million, accumulated depreciation of $70.7 million, and a net book value of
$37.3 million (See Note 10).
Note
5 – Convertible Subordinated Notes
The
outstanding balance of our convertible subordinated notes is as follows (in
thousands):
Semi-Annual
|
December 31,
|
||||||||
Interest Payment Dates
|
2009
|
2008
|
|||||||
3.25%
Notes due September 2012
|
March
28, September 28
|
$ | 214,955 | $ | 214,955 |
Our
convertible subordinated 3.25% notes due September 2012 (Notes) are unsecured
and subordinated in right of payment to any future senior debt. Costs related to
the issuance of these Notes are recorded in other assets in our Consolidated
Balance Sheets and are generally amortized to interest expense on a
straight-line basis over the contractual life of the Notes. The unamortized
deferred financing costs were $1.0 million and $2.2 million as of
December 31, 2009 and 2008, respectively.
Gain
on Extinguishment of Debt
During
the fourth quarter of 2008, we repurchased $100.0 million par value of the Notes
for $47.8 million. The recognized gain on debt extinguishment of $50.1 million
is net of transaction costs of $1.0 million and accelerated amortization of
deferred financing costs of $1.1 million.
Conversion
and Redemption
The Notes
are convertible at the option of the holder at any time on or prior to maturity
into shares of our common stock. The Notes have a conversion rate of 46.4727
shares per $1,000 principal amount, which is equal to a conversion price of
approximately $21.52 per share. Additionally, at any time prior to maturity, if
a fundamental change as defined in the Note agreement occurs, we may be required
to pay a make-whole premium on notes converted in connection therewith by
increasing the applicable conversion rate.
We may
redeem the Notes in whole or in part for cash at a redemption price equal to
100% of the principal amount of the Notes plus any accrued but unpaid interest
if the closing price of the common stock has exceeded 150% of the conversion
price for at least 20 days in any consecutive 30 day trading
period.
Note
6—Leases
Capital
Leases
We lease
office space and office equipment under capital lease arrangements. The gross
carrying value by major asset class and accumulated depreciation as of
December 31, 2009 and 2008 are as follows (in thousands):
65
December 31,
|
||||||||
2009
|
2008
|
|||||||
Building
and leasehold improvements
|
$ | 23,960 | $ | 23,962 | ||||
Furniture,
fixtures and other equipment
|
— | 261 | ||||||
Total
assets recorded under capital leases
|
$ | 23,960 | $ | 24,223 | ||||
Less:
accumulated depreciation
|
(10,072 | ) | (8,050 | ) | ||||
Net
assets recorded under capital leases
|
$ | 13,888 | $ | 16,173 |
We lease
office space at 201 Industrial Road in San Carlos, California under capital
lease arrangements. Under the terms of the lease, the rent will increase up to
3% annually. The lease termination date is October 5,
2016.
Future
minimum payments for our capital leases at December 31, 2009 are as follows
(in thousands):
Years
ending December 31,
|
||||
2010
|
$ | 4,752 | ||
2011
|
4,854 | |||
2012
|
4,956 | |||
2013
|
5,062 | |||
2014
|
5,169 | |||
2015
and thereafter
|
9,314 | |||
Total
minimum payments required
|
$ | 34,107 | ||
Less:
amount representing interest
|
(13,760 | ) | ||
Present
value of future payments
|
$ | 20,347 | ||
Less:
current portion
|
(1,547 | ) | ||
Non-current
portion
|
$ | 18,800 |
Operating
Leases
During
2008 and 2007, we were party to an operating lease for our San Carlos
manufacturing facility through 2012. On December 31, 2008, this operating
lease was assigned to Novartis Pharmaceuticals Inc as part of the pulmonary
asset sale. See Note 10. We have no further liabilities related
to this lease.
On
September 30, 2009, we entered into an operating sublease (Sublease) with
Pfizer, Inc. for a 102,283 square foot facility located at 455 Mission Bay
Boulevard, San Francisco, California (Mission Bay Facility). The Mission
Bay Facility is currently under construction and is scheduled to be completed by
the end of 2010. We are responsible for all tenant improvement costs
which we currently estimate to be approximately $20 million. When
completed, the Mission Bay Facility will include an R&D center with biology,
chemistry, pharmacology, and clinical development capabilities, as well as all
of our functions currently located in San Carlos, California, including our
corporate headquarters.
Under the
terms of the Sublease, we will begin making non-cancelable lease payments in
2014, after a four year free rent period currently estimated to end on August 1,
2014. The Sublease term commences in March 2010 and is 114 months,
currently estimated to end on January 30, 2020. Monthly base rent
will start at $2.95 per square foot and will escalate over the term of the
sublease at various intervals to $3.42 per square foot in the final period of
the Sublease term. Rent expense will be recognized ratably beginning March
2010, the inception of our tenant improvement construction period, though the
end of the Sublease term. In addition, throughout the term of the
Sublease, we are responsible for paying certain costs and expenses specified in
the sublease, including insurance costs and a pro rata share of operating
expenses and applicable taxes for the Mission Bay Facility.
66
Our
future minimum lease payments under the Mission Bay sublease are as follows (in
thousands):
Years
ending December 31,
|
||||
2010
|
$ | — | ||
2011
|
— | |||
2012
|
— | |||
2013
|
— | |||
2014
|
1,509 | |||
2015
and thereafter
|
19,811 | |||
Total
future minimum lease payments
|
$ | 21,320 |
We
recognize rent expense on a straight-line basis over the lease period. For
the years ended December 31, 2009, 2008, and 2007, rent expense for operating
leases was approximately $0.7 million, $3.5 million, and $4.3
million.
Note
7—Commitments and Contingencies
Royalty
Expense
We have
certain royalty commitments associated with the shipment and licensing of
certain products. Royalty expense, which is reflected in cost of goods sold in
our Consolidated Statements of Operations, was approximately $3.9 million, $4.8
million, and $3.9 million for the years ended December 31, 2009, 2008, and 2007,
respectively. The overall maximum amount of the obligations is based upon sales
of the applicable product and cannot be reasonably estimated.
Legal
Matters
From time
to time, we may be involved in lawsuits, claims, investigations and proceedings,
consisting of intellectual property, commercial, employment and other matters,
which arise in the ordinary course of business. We make provisions for
liabilities when it is both probable that a liability has been incurred and the
amount of the loss can be reasonably estimated. Such provisions are reviewed at
least quarterly and adjusted to reflect the impact of negotiations, settlements,
ruling, advice of legal counsel, and other information and events pertaining to
a particular case. Litigation is inherently unpredictable. If any unfavorable
ruling were to occur in any specific period, there exists the possibility of a
material adverse impact on the results of operations of that period or on our
cash flows and liquidity.
Indemnifications
in Connection with Commercial Agreements
As part
of our collaboration agreement with our partners related to the license,
development, manufacture and supply of drugs based on our proprietary
technologies, we generally agree to defend, indemnify and hold harmless our
partners from and against third party liabilities arising out of the agreement,
including product liability (with respect to our activities) and infringement of
intellectual property to the extent the intellectual property is developed by us
and licensed to our partners. The term of these indemnification obligations is
generally perpetual any time after execution of the agreement. There is
generally no limitation on the potential amount of future payments we could be
required to make under these indemnification obligations.
As part
of our pulmonary asset sale to Novartis that closed on December 31, 2008, we and
Novartis made representations and warranties and entered into certain covenants
and ancillary agreements which are supported by an indemnity obligation. In the
event it were determined that we breached any of the representations and
warranties or covenants and agreements made by us in the transaction documents,
we could incur an indemnification liability depending on the timing, nature, and
amount of any such claims.
To date
we have not incurred costs to defend lawsuits or settle claims related to these
indemnification obligations. If any of our indemnification obligations is
triggered, we may incur substantial liabilities. Because the obligated amount
under these agreements is not explicitly stated, the overall maximum amount of
the obligations cannot be reasonably estimated. No liabilities have been
recorded for these obligations on our Consolidated Balance Sheets as of December
31, 2009 or 2008.
67
Indemnification
of Underwriters and Initial Purchasers of our Securities
In
connection with our sale of equity and convertible debt securities, we have
agreed to defend, indemnify and hold harmless our underwriters or initial
purchasers, as applicable, as well as certain related parties from and against
certain liabilities, including liabilities under the Securities Act of 1933, as
amended. The term of these indemnification obligations is generally perpetual.
There is no limitation on the potential amount of future payments we could be
required to make under these indemnification obligations. We have never incurred
costs to defend lawsuits or settle claims related to these indemnification
obligations. If any of our indemnification obligations are triggered, however,
we may incur substantial liabilities. Because the obligated amount of this
agreement is not explicitly stated, the overall maximum amount of the
obligations cannot be reasonably estimated. Historically, we have not been
obligated to make significant payments for these obligations, and no liabilities
have been recorded for these obligations in our Consolidated Balance Sheets as
of December 31, 2009 or 2008.
Director
and Officer Indemnifications
As
permitted under Delaware law, and as set forth in our Certificate of
Incorporation and our Bylaws, we indemnify our directors, executive officers,
other officers, employees, and other agents for certain events or occurrences
that arose while in such capacity. The maximum potential amount of future
payments we could be required to make under this indemnification is unlimited;
however, we have insurance policies that may limit our exposure and may enable
us to recover a portion of any future amounts paid. Assuming the applicability
of coverage, the willingness of the insurer to assume coverage, and subject to
certain retention, loss limits and other policy provisions, we believe any
obligations under this indemnification are not material, other than an initial
$500,000 per incident for securities related claims and $250,000 per incident
for non-securities related claims retention deductible per our insurance policy.
However, no assurances can be given that the covering insurers will not attempt
to dispute the validity, applicability, or amount of coverage without expensive
litigation against these insurers, in which case we may incur substantial
liabilities as a result of these indemnification obligations. Because the
obligated amount of this agreement is not explicitly stated, the overall maximum
amount of the obligations cannot be reasonably estimated. Historically, we have
not been obligated to make significant payments for these obligations, and no
liabilities have been recorded for these obligations in our Consolidated Balance
Sheets as of December 31, 2009 or 2008.
Note
8—Stockholders’ Equity
Preferred
Stock
We have
authorized 10,000,000 shares of Preferred Stock, each share having a par value
of $0.0001. Of these shares, 3,100,000 shares are designated Series A Junior
Participating Preferred Stock (Series A Preferred Stock). The remaining shares
are undesignated. We have no preferred shares issued and outstanding as of
December 31, 2009 or 2008.
Series
A Preferred Stock
On June
1, 2001, the Board of Directors approved the adoption of a Share Purchase Rights
Plan. Terms of the Rights Plan provide for a dividend distribution of one
preferred share purchase right for each outstanding share of our Common Stock.
The Rights have certain anti-takeover effects and will cause substantial
dilution to a person or group that attempts to acquire us on terms not approved
by our Board of Directors. The dividend distribution was payable on June 22,
2001, to the stockholders of record on that date. Each Right entitles the
registered holder to purchase from us one one-hundredth of a share of Series A
Preferred Stock at a price of $225.00 per one one-hundredth of a share of Series
A Preferred Stock, subject to adjustment. Each one one-hundredth of a share of
Series A Preferred Stock has designations and powers, preferences and rights,
and the qualifications, limitations and restrictions which make its value
approximately equal to the value of one share of common stock.
The
Rights are not exercisable until the Distribution Date (as defined in the
Certificate of Designation for the Series A Preferred Stock). The Rights will
expire on June 1, 2011, unless the Rights are earlier redeemed or exchanged by
us. Each share of Series A Preferred Stock will be entitled to a minimum
preferential quarterly dividend payment of $1.00, or if greater than $1.00, will
be entitled to an aggregate dividend of 100 times the dividend declared per
share of Common Stock. In the event of liquidation, the holders of the Series A
Preferred Stock would be entitled to $100 per share or, if greater than $100, an
aggregate payment equal to 100 times the payment made per share of Common Stock.
Each share of Series A Preferred Stock will have 100 votes, voting together with
the Common Stock. Finally, in the event of any merger, consolidation or other
transaction in which our Common Stock is exchanged, each share of Series A
Preferred Stock will be entitled to receive 100 times the amount of
consideration received per share of Common Stock. The Series A Preferred Stock
would rank junior to any other future series of preferred stock. Until a Right
is exercised, the holder thereof, as such, will have no rights as a stockholder,
including, without limitation, the right to vote or to receive
dividends.
68
Reserved
Shares
At
December 31, 2009, we have reserved shares of common stock for issuance as
follows (in thousands):
As of December 31, 2009
|
||||
Convertible
subordinated notes
|
9,989 | |||
Stock
option plans
|
28,265 | |||
401(k)
retirement plans
|
220 | |||
Total
|
38,476 |
Stock
Option Plans
The
following table summarizes information with respect to shares of our common
stock that may be issued under our existing equity compensation plans as of
December 31, 2009 (share number in thousands):
Plan Category
|
Number of securities to be
issued upon exercise of
outstanding options
(a) (1)
|
Weighted-average
exercise price of
outstanding options
(b)
|
Number of securities remaining
available for issuance under
equity compensation plans
(excluding securities reflected
in column(a))
(c)
|
|||||||||
Equity
compensation plans approved by security
holders (2)
|
8,726 | $ | 9.61 | 10,967 | ||||||||
Equity
compensation plans not approved by security
holders
|
5,513 | $ | 9.17 | 3,029 | ||||||||
Total
|
14,239 | $ | 9.42 | 13,996 |
(1)
|
Does
not include options 31,738 shares we assumed in connection with the
acquisition of Shearwater Corporation (with a weighted-average exercise
price of $0.03 per share).
|
(2)
|
Includes
shares of common stock available for future issuance under our ESPP as of
December 31, 2009.
|
2008
Equity Incentive Plan
Our 2008
Equity Incentive Plan (2008 Plan) was adopted by the Board of Directors on March
20, 2008 and was approved by our stockholders on June 6, 2008. The purpose of
the 2008 Equity Incentive Plan is to attract and retain qualified personnel, to
provide additional incentives to our employees, officers, consultants and
employee directors and to promote the success of our business. Pursuant to the
2008 Plan, we may grant or issue incentive stock options to employees and
officers and non-qualified stock options, rights to acquire restricted stock,
restricted stock units, and stock bonuses to consultants, employees, officers
and non-employee directors.
The
maximum number of shares of our common stock that may be issued or transferred
pursuant to awards under the 2008 Plan is 9,000,000 shares. Shares issued in
respect of any stock bonus or restricted stock award granted under the 2008 Plan
will be counted against the plan’s share limit as 1.5 shares for every one share
actually issued in connection with the award. The 2008 Plan will terminate on
March 20, 2018, unless earlier terminated by the Board of
Directors.
The
maximum term of a stock option under the 2008 Equity Incentive Plan is eight
years, but if the optionee at the time of grant has voting power of more than
10% of our outstanding capital stock, the maximum term of an incentive stock
option is five years. The exercise price of stock options granted under the 2008
Plan must be at least equal to 100% (or 110% with respect to holders of more
than 10% of the voting power of our outstanding capital stock) of the fair
market value of the stock subject to the option as determined by the closing
price of our common stock on the Nasdaq Global Market on the date of
grant.
69
To the
extent that shares are delivered pursuant to the exercise of a stock option, the
number of underlying shares as to which the exercise related shall be counted
against the applicable share limits of the 2008 Plan, as opposed to only
counting the shares actually issued. Shares that are subject to or underlie
awards which expire or for any reason are cancelled or terminated, are
forfeited, fail to vest or for any other reason are not paid or delivered under
the 2008 Plan will again be available for subsequent awards under the 2008
Plan.
2000
Equity Incentive Plan
On April
19, 2000 the Board of Directors adopted our 2000 Equity Incentive Plan (2000
Plan) by amending and restating our 1994 Equity Incentive Plan. On
February 9, 2010, the 2000 Plan was terminated. As a result, no new
options may be granted, but existing options granted remain
outstanding. The purpose of the 2000 Equity Incentive Plan was to
attract and retain qualified personnel, to provide additional incentives to our
employees, officers, consultants and employee directors and to promote the
success of our business. Pursuant to the 2000 Plan, we granted or issued
incentive stock options to employees and officers and non-qualified stock
options, rights to acquire restricted stock, restricted stock units, and stock
bonuses to consultants, employees, officers and non-employee
directors.
The
maximum term of a stock option under the 2000 Plan is eight years, but if the
optionee at the time of grant has voting power of more than 10% of our
outstanding capital stock, the maximum term of an incentive stock option is five
years. The exercise price of incentive stock options granted under the 2000
Equity Incentive Plan must be at least equal to 100% (or 110% with respect to
holders of more than 10% of the voting power of our outstanding capital stock)
of the fair market value of the stock subject to the option as determined by the
closing price of our common stock on the Nasdaq Global Market on the date of
grant.
2000
Non-Officer Equity Incentive Plan
Our 1998
Non-Officer Equity Incentive Plan was adopted by the Board of Directors on
August 18, 1998, and was amended and restated in its entirety and renamed the
2000 Non-officer Equity Incentive Plan on June 6, 2000 (2000 Non-Officer Plan).
The purpose of the 2000 Non-Officer Plan is to attract and retain qualified
personnel, to provide additional incentives to employees and consultants and to
promote the success of our business. Pursuant to the 2000 Non-Officer Plan, we
may grant or issue non-qualified stock options, rights to acquire restricted
stock and stock bonuses to employees and consultants who are neither Officers
nor Directors of Nektar. The maximum term of a stock option under the 2000
Non-Officer Plan is eight years. The exercise price of stock options granted
under the 2000 Non-Officer Plan are determined by the Board of Directors by
reference to closing price of our common stock on the Nasdaq Global
Market.
Non-Employee
Directors’ Stock Option Plan
On
February 10, 1994, our Board of Directors adopted the Non-Employee Directors’
Stock Option Plan under which options to purchase up to 400,000 shares of our
Common Stock at the then fair market value may be granted to our non-employee
directors. There are no remaining options available for grant under this plan as
of December 31, 2009.
Restricted
Stock Units
During
the years ended December 31, 2009, 2008 and 2007, we issued RSU awards to
certain officers, non-employees, directors, employees and consultants. RSU
awards are similar to restricted stock in that they are issued for no
consideration; however, the holder generally is not entitled to the underlying
shares of common stock until the RSU award vests. Also, because the RSU awards
are issued for $0.01 per share, the grant-date fair value of the award is equal
to the intrinsic value of our common stock on the date of grant. The RSU awards
were issued under both the 2000 Plan and the 2000 Non-Officer Plan and are
settled by delivery of shares of our common stock on or shortly after the date
the awards vest.
Beginning
with shares granted in the year ended December 31, 2005, each RSU award depletes
the pool of options available for grant under our equity incentive plans by a
ratio of 1:1.5.
Employee
Stock Purchase Plan
In
February 1994, our Board
of Directors adopted the ESPP, pursuant to section 423(b) of the Internal
Revenue Code of 1986. Under the ESPP, 800,000 shares of common stock have been
authorized for issuance. The terms of the ESPP provide eligible employees with
the opportunity to acquire an ownership interest in Nektar through participation
in a program of periodic payroll deductions for the purchase of our common
stock. Employees may elect to enroll or re-enroll in the plan on a semi-annual
basis. Stock is purchased at 85% of the lower of the closing price on the first
day of the enrollment period or the last day of the enrollment
period.
70
401(k)
Retirement Plan
We
sponsor a 401(k) retirement plan whereby eligible employees may elect to
contribute up to the lesser of 60% of their annual compensation or the
statutorily prescribed annual limit allowable under Internal Revenue Service
regulations. The 401(k) plan permits us to make matching contributions on behalf
of all participants, up to a maximum of $3,000 per participant. For
the years ended December 31, 2009 and 2008, we recognized $0.8 million and $1.1
million, respectively, of compensation expense in connection with our 401(k)
retirement plan. For the year ended December 31, 2007, we issued
approximately 161,000 shares of common stock valued at $1.6 million in
connection with our 401(k) retirement plan.
Change
in Control Severance Plan
On
December 6, 2006, the Board of Directors approved a Change of Control Severance
Benefit Plan (CIC Plan) and on February 14, 2007 and October 21, 2008, the Board
of Directors amended and restated the CIC Plan. The CIC Plan is designed to make
certain benefits available to eligible employees of the Company in the event of
a change of control of the Company and, following such change of control, an
employee’s employment with the Company or a successor company is terminated in
certain specified circumstances. We adopted the CIC Plan to support the
continuity of the business in the context of a change of control transaction.
The CIC Plan was not adopted in contemplation of any specific change of control
transaction. A brief description of the material terms and conditions of the CIC
Plan is provided below.
Under the
CIC Plan, in the event of a change of control of the Company and a subsequent
termination of employment initiated by the Company or a successor company other
than for Cause or initiated by the employee for a Good Reason Resignation (as
hereinafter defined) in each case within twelve months following a change of
control transaction, (i) the Chief Executive Officer would be entitled to
receive cash severance pay equal to 24 months base salary plus annual target
incentive pay, the extension of employee benefits over this severance period and
the full acceleration of unvested outstanding equity awards, and (ii) the Senior
Vice Presidents and Vice Presidents (including Principal Fellows) would each be
entitled to receive cash severance pay equal to twelve months base salary plus
annual target incentive pay, the extension of employee benefits over this
severance period and the full acceleration of unvested outstanding equity
awards. In the event of a change of control of the Company and a subsequent
termination of employment initiated by the Company or a successor company other
than for cause within twelve months following a change of control transaction,
all other employees would each be entitled to receive cash severance pay equal
to 6 months base salary plus annual target incentive pay, the extension of
employee benefits over this severance period and the full acceleration of each
such employee’s unvested outstanding equity awards.
On
December 6, 2006, the Board of Directors approved an amendment to all
outstanding stock awards held by non-employee directors to provide for full
acceleration of vesting in the event of a change of control
transaction.
Note
9 —License and Collaboration Agreements
We have
entered into various license agreements and collaborative research and
development agreements with pharmaceutical and biotechnology companies. Under
these arrangements, we are entitled to receive license fees, upfront payments,
milestone payments when and if certain development or regulatory milestones are
achieved, and/or reimbursement for research and development activities. All of
our research and development agreements are generally cancelable by our partners
without significant financial penalty to the partner. Our costs of performing
these services are included in Research and development expense.
In
accordance with these agreements, we recorded License, collaboration and other
revenue as follows (in thousands):
Years ended December 31,
|
||||||||||||||
Partner
|
Agreement
|
2009
|
2008
|
2007
|
||||||||||
AstraZeneca
AB
|
NKTR-118
and NKTR-119
|
$ | 25,073 | $ | — | $ | — | |||||||
Bayer
Healthcare LLC
|
BAY41-6651
(NKTR-061, Amikacin Inhale)
|
4,928 | 10,054 | 1,306 | ||||||||||
F.
Hoffmann La-Roche
|
Pegasys
|
214 | 1,000 | — | ||||||||||
Novartis
Vaccines and Diagnostics, Inc.
|
Tobramycin
inhalation powder (TIP)
|
564 | 13,723 | 17,036 | ||||||||||
Bayer
Schering Pharma AG
|
Cipro
Inhale (CIP)
|
— | 11,653 | 8,116 | ||||||||||
Pfizer
Inc.
|
Exubera®
inhalation powder and Next-generation inhaled insulin
(NGI)
|
— | — | 49,490 | ||||||||||
Other
|
5,864 | 12,500 | 16,324 | |||||||||||
License,
collaboration and other revenue
|
$ | 36,643 | $ | 48,930 | $ | 92,272 |
71
AstraZeneca
AB
NKTR-118
and NKTR-119
On
September 20, 2009, we entered into a License Agreement with AstraZeneca AB, a
Swedish corporation (AstraZeneca), under which we granted AstraZeneca a
worldwide, exclusive, perpetual, royalty-bearing, and sublicensable license
under our patents and other intellectual property to develop, sell and otherwise
commercially exploit Oral NKTR-118 and NKTR-119. AstraZeneca will
bear all costs associated with research, development and commercialization and
will control product development and commercialization decisions for Oral
NKTR-118 and NKTR-119. Under the terms of the agreement, AstraZeneca
paid us an upfront payment of $125.0 million, which we received in the fourth
quarter of 2009, of which we recognized $23.6 million as License, collaboration
and other revenue in 2009. As of December 31, 2009, we have deferred
revenue of approximately $101.4 million, which we expect to amortize over
through the technology transfer period, which is expected to be the end of
2010. We are also entitled to development milestones and sales
milestones upon achievement of certain annual sales targets and royalties based
on annual worldwide net sales of Oral NKTR-118 and NKTR-119 products. We
recognized $1.5 million in reimbursement for technology transfer services
related to this agreement during the year ended December 31, 2009.
F.
Hoffmann La-Roche Ltd and Hoffmann-LaRoche Inc.
PEGASYS
In
February 1997, we entered into a license, manufacturing and supply agreement
with F. Hoffmann-La Roche Ltd and Hoffmann-La Roche Inc. (Roche), under which we
granted Roche a worldwide, exclusive license to use certain PEGylation materials
in the manufacture of PEGASYS. As a result of Roche exercising a license
extension option in December 2009, beginning in 2010 Roche has the right to
manufacture all of its requirements for our proprietary PEGylation materials for
PEGASYS and we would perform additional manufacturing, if any, only on an as
requested basis. In connection with Roche’s exercise of the license
option extension in December 2009, we received a payment of $31.0 million of
which we have recognized $0.2 million during the year ended December 31,
2009. As of December 31, 2009, we have deferred revenue of
approximately $30.8 million, which we expect to amortize over the period through
which we are required to provide back-up manufacturing and supply services on an
as-requested basis.
Bayer
Healthcare LLC
BAY41-6651
(NKTR-061, Amikacin Inhale)
On August
1, 2007, we entered into a co-development, license and co-promotion agreement
with Bayer Healthcare LLC to develop a specially-formulated inhaled Amikacin
(BAY41-6651). We are responsible for any future development of the nebulizer
device included in the Amikacin product through the completion of Phase 3
clinical trial, scale-up for commercialization, and commercial manufacturing and
supply. Bayer Healthcare LLC is responsible for most future clinical development
and commercialization costs, all activities to support worldwide regulatory
filings, approvals and related activities, further development of BAY41-6651 and
final product packaging. We received an upfront payment of $40.0 million in 2007
and performance milestone payments of $20.0 million, of which we have recognized
$5.0 million, $10.1 million, and $1.3 million during the years ended December
31, 2009, 2008, and 2007, respectively. As of December 31, 2009, we
have deferred revenue of approximately $33.8 million, which we expect to
amortize through July 2021, the estimated end of the life of the
agreement. We are entitled to development milestones and sales
milestones upon achievement of certain development milestones and annual sales
targets and royalties based on annual worldwide net sales of BAY
41-6651.
Novartis
Tobramycin
inhalation powder (TIP)
We were
party to a collaborative research, development and commercialization agreement
with Novartis Vaccines and Diagnostics, Inc. related to the development of
Tobramycin inhalation powder (TIP) for the treatment of lung infections caused
by the bacterium Pseudomonas
aeruginosa in cystic fibrosis patients. Our collaborative research,
development and commercialization agreement with Novartis Vaccines and
Diagnostics, Inc. for related to TIP was terminated on December 31, 2008. As
part of the termination, we relinquished our rights to future research and
development funding and milestone payments, as well as to any future royalty
payments or manufacturing revenue. Prior to the termination, we were
reimbursed for the cost of work performed on a revenue per annual full-time
equivalent (FTE) basis, plus out of pocket third party costs. Revenue recognized
approximated the cost associated with these services and was $0.6 million, $14.3
million, and $17.0 million during the years ended December 31, 2009, 2008, and
2007, respectively.
72
Bayer
Schering Pharma AG
Cipro
Inhale
We were
party to a collaborative research, development and commercialization agreement
with Bayer Schering Pharma AG related to the development of an inhaled powder
formulation of Cipro Inhale for the treatment of chronic lung infections caused
by Pseudomonas aeruginosa
in cystic fibrosis patients. As of December 31, 2008, we assigned the
collaborative research, development and commercialization agreement to Novartis
Pharma AG through which we maintain the right to receive potential royalties in
the future based on net product sales if Cipro Inhale receives regulatory
approval and is successfully commercialized (See Note 10). Prior to
the termination, we were reimbursed for the cost of work performed on a revenue
per annual FTE basis and out of pocket third party costs, as well as milestone
and upfront fees. Revenue recognized approximated the cost associated with these
services and totaled nil, $10.3 million, and $7.7 million during the years ended
December 31, 2009, 2008, and 2007, respectively.
Pfizer
Inc.
Exubera®
inhalation powder and Next-generation inhaled insulin (NGI)
We were a
party to collaboration agreements with Pfizer related to the development of
Exubera and the next-generation inhaled insulin that terminated on November 9,
2007 (See Note 11). Under the terms of the collaboration agreements,
we received contract research and development revenue as well as milestone and
upfront fees related to the Exubera bulk powder insulin manufacturing, Exubera
inhaler device manufacturing through our contract manufacturers, and development
related to NGI. We were reimbursed for the cost of work performed on a revenue
per annual FTE basis, plus out of pocket third party costs. Revenue recognized
approximates the cost associated with these services and was nil, nil, and $18.5
million during the years ended December 31, 2009, 2008, and 2007,
respectively.
Note 10 - Novartis Pulmonary Asset
Sale
On
December 31, 2008, we completed the sale of certain assets related to our
pulmonary business, associated technology and intellectual property to Novartis
Pharma AG and Novartis Pharmaceuticals Corporation (together referred to as
Novartis) for a purchase price of $115.0 million in cash (the Novartis Pulmonary
Asset Sale). Pursuant to the asset purchase agreement entered between Novartis
and us, we transferred to Novartis certain assets and obligations related to our
pulmonary technology, development and manufacturing operations
including:
|
•
|
dry
powder and liquid pulmonary technology platform including but not limited
to our pulmonary inhalation devices, formulation technology, manufacturing
technology and related intellectual
property;
|
|
•
|
manufacturing
and associated development services payments for the Cipro Inhale
program;
|
|
•
|
manufacturing
and royalty rights to the TIP
program;
|
|
•
|
capital
equipment, information systems and facility lease obligations for our
pulmonary development and manufacturing facility in San Carlos,
California;
|
|
•
|
certain
other interests that we had in two private companies, Pearl Therapeutics,
Inc. and Stamford Devices Limited;
and
|
|
•
|
approximately
140 of our personnel primarily dedicated to our pulmonary technology,
development programs, and manufacturing operations, whom Novartis hired
immediately following the closing of the
transaction.
|
We have
retained all of our rights to BAY41-6651 partnered with Bayer Healthcare LLC,
certain royalty rights on commercial sales of Cipro Inhale by Bayer Schering
Pharma AG, all rights to the development program for NKTR-063 and certain
intellectual property rights specific to inhaled insulin. We also
entered into a service agreement pursuant to which we have subcontracted to
Novartis certain services to be performed related to BAY41-6551 and a transition
services agreement in which Novartis and we will provide each other with
specified services for limited time periods following the closing of the
Novartis Pulmonary Asset Sale to facilitate the transition of the acquired
assets and business from us to Novartis.
73
Gain
on sale of pulmonary assets
On
December 31, 2008, we recognized a Gain on sale of pulmonary assets for certain
assets sold to Novartis, which is comprised of the following (in
thousands):
Year ended December 31,
2008
|
||||
Proceeds
from sale of certain pulmonary assets
|
$ | 115,000 | ||
Transaction
costs(1)
|
(4,609 | ) | ||
Net
book value of property and equipment sold
|
(37,291 | ) | ||
Equity
investment in Pearl Therapeutics, net
|
(2,658 | ) | ||
Goodwill
related to pulmonary assets sold
|
(1,930 | ) | ||
Other,
net
|
1,060 | |||
Gain
on sale of pulmonary assets
|
$ | 69,572 |
(1)
|
Transaction
costs of $4.4 million related to the Novartis Pulmonary Asset Sale were
paid in 2009.
|
Additional
Costs
In
addition to the transaction costs recorded as part of the gain, we recognized
approximately $0.1 million and $2.7 million of additional costs in connection
with the Novartis Pulmonary Asset Sale for the years ended December 31, 2009 and
2008, respectively, of one-time employee termination and other costs that were
recorded in Research and development expense in our Consolidated Statement of
Operations. All costs incurred have been paid as of December 31,
2009. We expect to incur approximately $1.0 million as a result of
the Novartis Pulmonary Asset Sale when we relocate our IT server room in
2010.
Note
11 – Termination of Pfizer Agreements and Inhaled Insulin Program
On
November 9, 2007, we entered into a termination agreement and mutual release of
our collaborative development and license agreement with Pfizer and all other
related agreements (Pfizer agreements). Under the termination
agreement, we received a one-time payment of $135.0 million in November 2007
from Pfizer in satisfaction of all outstanding contractual obligation under our
existing agreements related to Exubera and NGI. Contractual
obligations included billed and unbilled product sales and contract research
revenue through November 9, 2007, outstanding accounts receivable and
unrecovered capital costs as of November 9, 2007, and contract termination
costs.
February
12, 2008, we entered into a Termination and 2008 Continuation Agreement (TCA)
with Tech Group pursuant to which the manufacturing and supply agreement for the
Exubera inhaler device (Exubera Inhaler MSA) was terminated in its entirety and
we agreed to pay Tech Group $13.8 million in termination costs and $4.8 million
in satisfaction of outstanding accounts payable. As part of the TCA, we agreed
to compensate Tech Group to retain a limited number of core Exubera inhaler
manufacturing personnel and its dedicated Exubera inhaler manufacturing facility
for a limited period in 2008. We also entered into a letter agreement with
Pfizer to retain a limited number of Exubera manufacturing personnel at Pfizer’s
Terre Haute, Indiana, manufacturing facility during March and April
2008.
On
February 14, 2008, we entered into a Termination and Mutual Release Agreement
with Bespak pursuant to which the Exubera Inhaler MSA was terminated in its
entirety and we agreed to pay Bespak £11.0 million, or approximately $21.6
million, including $3.0 million in satisfaction of outstanding accounts payable
and $18.6 million in termination costs and expenses that were due and payable
under the termination provisions of the Exubera Inhaler MSA, which included
reimbursement of inventory, inventory purchase commitments, unamortized
depreciation on property and equipment, severance costs and operating lease
commitments.
On April
9, 2008, we announced that we had ceased all negotiations with potential
partners for Exubera and NGI as a result of new data analysis from ongoing
clinical trials conducted by Pfizer which indicated an increase in the number of
new cases of lung cancer in Exubera patients who were former smokers as compared
to patients in the control group who were former smokers. Following the
termination of our inhaled insulin programs on April 9, 2008, we terminated our
continuation agreements with Tech Group and Pfizer.
74
Gain
on Termination of Collaborative Agreements, Net
During
the year ended December 31, 2007, we recognized a Gain on termination of
collaborative agreements, net which is comprised of the following (in
thousands):
Year ended December 31,
2007
|
||||
Pfizer
termination settlement payment received
|
$ | 135,000 | ||
Exubera
Inhaler Manufacturing and Supply Agreement Termination
|
||||
Tech
Group
|
(13,765 | ) | ||
Bespak
|
(18,598 | ) | ||
102,637 | ||||
Settlement
of assets and liabilities related to Pfizer
|
(23,459 | ) | ||
Gain
on termination of collaborative agreements, net
|
$ | 79,178 |
Idle
Exubera Manufacturing Capacity Costs
Idle
Exubera manufacturing capacity costs, which is disclosed as a component of Other
cost of revenue, include costs payable to Pfizer and Tech Group under our
continuation agreements and internal salaries, benefits and stock-based
compensation related to Exubera commercial manufacturing employees, overhead at
our San Carlos manufacturing facility, including rent, utilities and maintenance
and depreciation of property and equipment. We incurred these costs from the
termination of the Pfizer Agreements on November 9, 2007 through the termination
of our inhaled insulin programs in April 2008. For the years ended December 31,
2009, 2008 and 2007, we recognized idle Exubera manufacturing capacity costs of
nil, $6.8 million, and $6.3 million, respectively.
Accrued
Expenses to Contract Manufacturer
As of December 31, 2007, we recorded
$40.4 million of accrued expenses to Bespak and Tech Group for outstanding
accounts payable and termination costs and expenses that were due and payable
under the termination provisions of the Exubera Inhaler MSA. This
liability was repaid in its entirety in 2008. As of December 31,
2008, we had no further liabilities related to the Pfizer
Agreements.
Note
12—Impairment of Long Lived Assets
During
the years ended December 31, 2009, 2008, and 2007, we recorded charges for the
Impairment of long-lived assets of nil, $1.5 million, and $28.4 million,
respectively.
During
2008, we determined that a specialized dryer used in our PEGylation
manufacturing facility was not functioning properly and was not being used in
operations currently. We performed an impairment analysis and determined the
carrying value of the dryer exceeded its fair value based on a discounted cash
flow model. As a result, we recorded an impairment loss for the related net book
value of $1.5 million.
On
November 9, 2007, we entered into a termination agreement and mutual release
with Pfizer related to Exubera and NGI. As a result, we performed an impairment
analysis of the property and equipment that supported Exubera commercial
operations and NGI (Exubera-related assets), including machinery and equipment
at our contract manufacturer locations and machinery, equipment, and leasehold
improvements in San Carlos, and determined the fair value of such assets based
on a discounted cash flow model. As of December 31, 2007, we concluded the
carrying value of the Exubera-related assets exceeded the estimated future cash
flows and recorded an impairment charge of $28.4 million (See Note
11).
Note
13—Workforce Reduction Plans
In an
effort to reduce ongoing operating costs and improve our organizational
structure, efficiency and productivity, we executed workforce reduction plans in
May 2007 (2007 Plan) and February 2008 (2008 Plan) designed to streamline the
Company, consolidate corporate functions, and strengthen decision-making and
execution within our business units. The 2007 Plan and 2008 Plan reduced our
workforce by approximately 290 full-time employees; both plans were
substantially complete at December 31, 2008. For the years ended
December 31, 2009, 2008, and 2007 workforce reduction charges, comprised of
severance, medical insurance, and outplacement services, were as follows (in
thousands):
75
Years ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Cost
of goods sold, net of inventory change
|
$ | — | $ | 148 | $ | 974 | ||||||
Other
cost of revenue
|
— | 1,221 | — | |||||||||
Research
and development expense
|
— | 3,087 | 5,791 | |||||||||
General
and administrative expense
|
— | 517 | 1,617 | |||||||||
Total
workforce reduction charges
|
$ | — | $ | 4,973 | $ | 8,382 |
Note
14 – Stock-Based Compensation
We issued
stock-based awards from our equity incentive plans, which are more fully
described in Note 8. Stock-based compensation cost was recorded as
follows (in thousands):
Years ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Cost
of goods sold, net of change in inventory
|
$ | 295 | $ | 269 | $ | 1,003 | ||||||
Research
and development
|
3,377 | 4,642 | 6,275 | |||||||||
General
and administrative
|
6,654 | 4,960 | 5,915 | |||||||||
Total
compensation cost for share-based arrangements
|
$ | 10,326 | $ | 9,871 | $ | 13,193 |
For the
years ended December 31, 2009, 2008, and 2007, we recorded approximately $0.8
million, $2.2 million, and $0.5 million, respectively, of stock-based
compensation expense related to modifications of certain stock grants in
connection with employment separation agreements. Generally, the modifications
extended the option holder’s exercise period beyond the 90 day period after
termination and accelerated a portion of the option holder’s unvested grants.
Stock-based compensation charges are non-cash charges and as such have no impact
on our reported cash flows.
For the
year ended December 31, 2009, the annual forfeiture rate for options issued to
directors and employees was estimated to be 15% and 11%,
respectively. For the year ended December 31, 2008, the annual
forfeiture rate for options issued to directors and employees was estimated to
0% and 11%, respectively, and the annual forfeiture rate for employee RSU awards
was estimated to be 25%. For the year ended December 31, 2007, the
annual forfeiture rate for options issued to both directors and to employees was
estimated to be 4.7%. All forfeiture rates are based on our
qualitative and quantitative analysis of our historical
forfeitures.
Aggregate
Unrecognized Stock-based Compensation Expense
As of
December 31, 2009, total unrecognized compensation expense related to unvested
stock-based compensation arrangements is expected to be recognized over a
weighted-average period of 1.88 years as follows (in thousands):
Fiscal Year
|
As of
December 31,
2009
|
|||
2010
|
$ | 10,056 | ||
2011
|
8,311 | |||
2012
|
3,787 | |||
2013
and thereafter
|
1,640 | |||
$ | 23,794 |
Black-Scholes
Assumptions
The
following tables list the Black-Scholes assumptions used to calculate the fair
value of employee stock options and ESPP purchases.
Year ended December 31, 2009
|
Year ended December 31, 2008
|
Year ended December 31, 2007
|
||||||||||||||||||||||
Employee
Stock Options
|
ESPP
|
Employee
Stock Options
|
ESPP
|
Employee
Stock Options
|
ESPP
|
|||||||||||||||||||
Average
risk-free interest rate
|
1.6 | % | 0.3 | % | 2.5 | % | 2.0 | % | 4.2 | % | 4.8 | % | ||||||||||||
Dividend
yield
|
0.0 | % | 0.0 | % | 0.0 | % | 0.0 | % | 0.0 | % | 0.0 | % | ||||||||||||
Volatility
factor
|
61.0 | % | 82.4 | % | 51.6 | % | 72.3 | % | 53.3 | % | 38.4 | % | ||||||||||||
Weighted
average expected life
|
4.9
years
|
0.5
years
|
5.0
years
|
0.5
years
|
5.1
years
|
0.5
years
|
Expected
volatility is based on historical volatility of our common
stock.
76
As
permitted by the Securities and Exchange Commission (SEC) Staff Accounting
Bulletin Topic 14.D.2, we estimated the expected life of stock options
using the “simplified” method during the years ended December 31, 2009,
2008, and 2007. Under this method, the expected life was equal to the arithmetic
average of the vesting term and the original contractual term of the option. We
are using this method because we believe that applying historical data for
options and awards is not a true reflection of future exercise patterns and
timelines. Generally our stock-based grants have expected terms ranging from 51
months to 61 months.
Summary
of Stock Option Activity
The table
below presents a summary of stock option activity under our equity incentive
plans (in thousands, except for price per share and contractual life
information):
Options Outstanding
|
Weighted-
Average
Exercise
|
Weighted-
Average
Remaining
|
Aggregate
|
|||||||||||||||||
Number
of
Shares
|
Exercise
Price
Per Share
|
Price
Per Share
|
Contractual
Life (in years)
|
Intrinsic
Value (1)
|
||||||||||||||||
Balance
at December 31, 2006
|
10,707 | $ | 0.01–61.63 | $ | 18.97 | 4.78 | $ | 15,348 | ||||||||||||
Options
granted
|
5,257 | 5.98–15.24 | 9.87 | |||||||||||||||||
Options
exercised
|
(429 | ) | 0.01–14.25 | 6.80 | $ | 1,770 | ||||||||||||||
Options
forfeited & canceled
|
(3,323 | ) | 4.50–55.19 | 18.47 | ||||||||||||||||
Balance
at December 31, 2007
|
12,212 | $ | 0.01–61.63 | $ | 15.62 | 5.20 | $ | 643 | ||||||||||||
Options
granted
|
6,180 | 2.83–7.13 | 6.02 | |||||||||||||||||
Options
exercised
|
(39 | ) | 0.03–7.33 | 5.72 | $ | 42 | ||||||||||||||
Options
forfeited & canceled
|
(4,802 | ) | 0.01–61.63 | 12.93 | ||||||||||||||||
Balance
at December 31, 2008
|
13,551 | $ | 0.01–60.88 | $ | 12.13 | 4.84 | $ | 2,032 | ||||||||||||
Options
granted
|
4,608 | 4.20–9.61 | 5.53 | |||||||||||||||||
Options
exercised
|
(714 | ) | 0.01–9.49 | 6.58 | $ | 1,379 | ||||||||||||||
Options
forfeited & canceled
|
(3,437 | ) | 3.35–60.88 | 15.53 | ||||||||||||||||
Balance
at December 31, 2009
|
14,008 | $ | 0.03–54.75 | $ | 9.41 | 5.40 | $ | 34,151 | ||||||||||||
Exercisable
at December 31, 2009
|
6,904 | $ | 12.47 | 3.96 | $ | 11,358 | ||||||||||||||
Exercisable
at December 31, 2008
|
7,144 | $ | 16.57 | 2.89 | $ | 276 | ||||||||||||||
Exercisable
at December 31, 2007
|
7,023 | $ | 19.15 | 3.64 | $ | 584 |
(1)
|
Aggregate
Intrinsic Value represents the difference between the exercise price of
the option and the closing market price of our common stock on the
exercise date or December 31, as
applicable.
|
The
weighted-average grant-date fair value of options granted during the years ended
December 31, 2009, 2008, and 2007 was $2.86, $2.79, and $5.11, respectively. The
estimated fair value of options that vested during the years ended December 31,
2009, 2008, and 2007 was $9.0 million, $9.8 million, and $8.7 million,
respectively.
The
following table provides information regarding our outstanding stock options as
of December 31, 2009 (in thousands except for price per share and contractual
life information):
Options Outstanding
|
Options Exercisable
|
|||||||||||||||||||
Range of
Exercise
Prices
|
Number of Shares
|
Weighted-Average
Exercise Price Per
Share
|
Weighted-Average
Remaining Contractual
Life (in years)
|
Number of Shares
|
Weighted-Average
Exercise Price Per
Share
|
|||||||||||||||
$0.03
– $4.37
|
799 | $ | 4.00 | 6.28 | 315 | $ | 3.77 | |||||||||||||
$4.44
– $4.65
|
2,927 | $ | 4.65 | 7.10 | 482 | $ | 4.64 | |||||||||||||
$4.67
– $6.34
|
1,455 | $ | 5.62 | 6.44 | 532 | $ | 5.25 | |||||||||||||
$6.36
– $6.46
|
659 | $ | 6.46 | 5.90 | 310 | $ | 6.46 | |||||||||||||
$6.50
– $6.65
|
1,930 | $ | 6.65 | 5.72 | 909 | $ | 6.65 | |||||||||||||
$6.67
– $7.78
|
1,410 | $ | 7.01 | 5.75 | 707 | $ | 7.05 | |||||||||||||
$7.84
– $11.38
|
1,540 | $ | 9.37 | 5.89 | 741 | $ | 9.55 | |||||||||||||
$11.41
– $16.85
|
1,405 | $ | 14.06 | 4.02 | 1,066 | $ | 13.95 | |||||||||||||
$17.01
– $27.69
|
1,409 | $ | 21.57 | 1.68 | 1,368 | $ | 21.65 | |||||||||||||
$27.88
– $54.75
|
474 | $ | 32.23 | 0.83 | 474 | $ | 32.23 | |||||||||||||
14,008 | $ | 9.41 | 5.40 | 6,904 | $ | 12.47 |
77
RSU
Awards
We issued
RSU awards to certain officers and employees; the RSU awards granted in 2006
vest upon achievement of pre-determined performance milestones, while the RSU
awards granted in 2007 and 2008 have a time-based vesting
schedule. We expense the grant date fair value of the RSU awards
ratably over the expected service or performance period. The weighted
average life of the 2009, 2008, and 2007 RSU awards is estimated to be 1.0
years, 0.8 years, and 1.2 years, respectively.
We
granted 1,088,300 performance-based RSU awards in 2006, which included three
pre-determined milestones. The first performance milestone was
achieved and the RSU awards were vested and released in 2007. In
2007, we determined the second performance milestone would not be achieved and
we reversed previously recorded compensation expense of $2.8
million. We currently expect the third milestone will be achieved in
2012. If our actual experience in future periods differs from these
current estimates, we may change our estimate of the period in which the
milestone will be achieved and prospectively adjust the amortization period of
the stock based compensation expense associated with these awards.
A summary
of RSU award activity is as follows (in thousands except for contractual life
and per share amounts):
Units Issued
|
Weighted-Average
Remaining
Contractual Life
(in years)
|
Weighted-Average
Grant-Date
Fair value
|
Aggregate
Intrinsic
Value (1)
|
|||||||||||||
Balance
at December 31, 2006
|
1,084 | 1.52 | $ | 16,479 | ||||||||||||
Granted
|
345 | $ | 11.01 | |||||||||||||
Released
|
(334 | ) | $ | 3,808 | ||||||||||||
Forfeited
& canceled
|
(360 | ) | ||||||||||||||
Balance
at December 31, 2007
|
735 | 2.03 | $ | 4,925 | ||||||||||||
Granted
|
48 | $ | 5.26 | |||||||||||||
Released
|
(107 | ) | $ | 487 | ||||||||||||
Forfeited
& canceled
|
(411 | ) | ||||||||||||||
Balance
at December 31, 2008
|
265 | 2.48 | $ | 1,472 | ||||||||||||
Granted
|
35 | $ | 8.37 | |||||||||||||
Released
|
(28 | ) | $ | 142 | ||||||||||||
Forfeited
& canceled
|
(37 | ) | ||||||||||||||
Balance
at December 31, 2009
|
235 | 1.99 | $ | 2,188 |
(1)
|
Aggregate
Intrinsic Value represents the difference between the exercise price of
the award and the closing market price of our common stock on the exercise
date or December 31, as
applicable.
|
78
Note
15 – Income Taxes
For
financial reporting purposes, “Loss before provision for income taxes,” includes
the following components (in thousands):
Years ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Domestic
|
$ | (103,295 | ) | $ | (69,350 | ) | $ | (30,143 | ) | |||
Foreign
|
523 | 34,208 | (1,309 | ) | ||||||||
Total
|
$ | (102,772 | ) | $ | (35,142 | ) | $ | (31,452 | ) |
(Benefit)
Provision for Income Taxes
The
(benefit) provision for income taxes consists of the following (in
thousands):
Years ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Current:
|
||||||||||||
Federal
|
$ | (522 | ) | $ | (970 | ) | $ | 194 | ||||
State
|
(28 | ) | (69 | ) | 782 | |||||||
Foreign
|
352 | 519 | 333 | |||||||||
Total
Current
|
(198 | ) | (520 | ) | 1,309 | |||||||
Deferred:
|
||||||||||||
Federal
|
— | — | — | |||||||||
State
|
— | — | — | |||||||||
Foreign
|
(55 | ) | (286 | ) | — | |||||||
Total
Deferred
|
(55 | ) | (286 | ) | — | |||||||
(Benefit)
Provision for income taxes
|
$ | (253 | ) | $ | (806 | ) | $ | 1,309 |
In 2009,
we received a federal tax refund of $0.9 million as a result of the Housing and
Economic Recovery Act of 2008, which allowed us to utilize previously recorded
deferred tax assets.
Income
tax (benefit) provision related to continuing operations differs from the
amounts computed by applying the statutory income tax rate of 35% to pretax loss
as follows (in thousands):
Years ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
U.S.
federal provision (benefit)
|
||||||||||||
At
statutory rate
|
$ | (35,970 | ) | $ | (12,300 | ) | $ | (10,998 | ) | |||
State
taxes
|
(28 | ) | (69 | ) | 782 | |||||||
Change
in valuation allowance
|
34,327 | 29,768 | 27,829 | |||||||||
Foreign
tax differential
|
114 | (11,754 | ) | — | ||||||||
Unrecognized
tax credits
|
(882 | ) | (2,366 | ) | (13,109 | ) | ||||||
Expiring
tax attributes
|
1,569 | 1,508 | — | |||||||||
Capital
lease true-up
|
— | (1,431 | ) | — | ||||||||
Foreign
subsidiary investment
|
— | (4,777 | ) | — | ||||||||
Sale
of Irish subsidiary
|
— | — | (3,604 | ) | ||||||||
Other
|
617 | 615 | 409 | |||||||||
Total
|
$ | (253 | ) | $ | (806 | ) | $ | 1,309 |
Deferred
Tax Assets and Liabilities
Deferred
income taxes reflect the net tax effects of loss and credit carryforwards and
temporary differences between the carrying amount of assets and liabilities for
financial reporting purposes and the amounts used for income tax
purposes. Significant components of our deferred tax assets for
federal and state income taxes are as follows (in thousands):
79
December 31,
|
||||||||
2009
|
2008
|
|||||||
Deferred
tax assets:
|
||||||||
Net
operating loss carryforwards
|
$ | 321,874 | $ | 289,631 | ||||
Research
and other credits
|
48,186 | 50,350 | ||||||
Capitalized
research expenses
|
6,905 | 4,563 | ||||||
Deferred
revenue
|
34,226 | 28,659 | ||||||
Reserve
and accruals
|
5,184 | 9,629 | ||||||
Stock
based compensation
|
22,303 | 20,315 | ||||||
Other
|
4,812 | 5,163 | ||||||
Deferred
tax assets before valuation allowance
|
443,490 | 408,310 | ||||||
Valuation
allowance for deferred tax assets
|
(442,473 | ) | (402,907 | ) | ||||
Total
deferred tax assets
|
$ | 1,017 | $ | 5,403 | ||||
Deferred
tax liabilities:
|
||||||||
Depreciation
|
(678 | ) | (1,479 | ) | ||||
Acquisition
related intangibles
|
— | (3,352 | ) | |||||
Other
|
— | (286 | ) | |||||
Total
deferred tax liabilities
|
$ | (678 | ) | $ | (5,117 | ) | ||
Net
deferred tax assets
|
$ | 339 | $ | 286 |
Realization
of our deferred tax assets is dependent upon future earnings, if any, the timing
and amount of which are uncertain. Because of our lack of U.S. earnings history,
the net U.S. deferred tax assets have been fully offset by a valuation
allowance. The valuation allowance increased by $39.9 million and $27.6 million
during the years ended December 31, 2009 and 2008, respectively. The valuation
allowance includes approximately $35.6 million of benefit at both December 31,
2009 and December 31, 2008 related to stock based compensation and exercises,
prior to the implementation of SFAS No. 123R, that will be credited to
additional paid in capital when realized.
Undistributed
earnings of our foreign subsidiary in India are considered to be permanently
reinvested and accordingly, no deferred U.S. income taxes have been provided
thereon. Upon distribution of those earnings in the form of dividends or
otherwise, we would be subject to U.S. income tax.
Net
Operating Loss and Tax Credit Carryforwards
As of
December 31, 2009, we had a net operating loss carryforward for federal income
tax purposes of approximately $795.9 million, portions of which will begin to
expire in 2010. We had a total state net operating loss carryforward of
approximately $496.6 million, which will begin to expire in 2010. Utilization of
the federal and state net operating loss and credit carryforwards may be subject
to a substantial annual limitation due to the “change in ownership” provisions
of the Internal Revenue Code of 1986 and similar state provisions. The annual
limitation may result in the expiration of net operating losses and credits
before utilization.
We have
federal research credits of approximately $21.3 million, which will begin to
expire in 2010 and state research credits of approximately $14.2 million which
have no expiration date. We have federal orphan drug credits of $12.8 million
which will begin to expire in 2024.
Unrecognized
tax benefits
We have
the following activity relating to unrecognized tax benefits (in
thousands):
December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
Beginning
balance
|
$ | 11,660 | $ | 9,222 | $ | 7,176 | ||||||
Tax
positions related to current year
|
||||||||||||
Additions:
|
||||||||||||
Federal
|
415 | 1,274 | 1,497 | |||||||||
State
|
318 | 1,164 | 548 | |||||||||
Reductions
|
— | — | — | |||||||||
Tax
positions related to prior year
|
||||||||||||
Additions:
|
— | — | — | |||||||||
Federal
|
— | — | — | |||||||||
State
|
691 | — | — | |||||||||
Reductions
|
— | — | — | |||||||||
Settlements
|
— | — | — | |||||||||
Lapses
in statute of limitations
|
— | — | — | |||||||||
Ending
balance
|
$ | 13,084 | $ | 11,660 | $ | 9,222 |
80
It is
reasonably possible that certain unrecognized tax benefits may increase or
decrease within the next twelve months due to tax examination changes,
settlement activities, expirations of statute of limitations, or the impact on
recognition and measurement considerations related to the results of published
tax cases or other similar activities. We do not anticipate any significant
changes to unrecognized tax benefits over the next 12 months. During the years
ended December 31, 2009 and 2008, no interest or penalties were required to be
recognized relating to unrecognized tax benefits.
Note
16—Segment Reporting
We
operate in one business segment which focuses on applying our technology
platforms to improve the performance of established and novel medicines. We
operate in one segment because our business offerings have similar economics and
other characteristics, including the nature of products and production
processes, types of customers, distribution methods and regulatory environment.
We are comprehensively managed as one business segment by our Chief Executive
Officer and his management team. Within our one business segment we have two
components, PEGylation technology and pulmonary technology.
Our
revenue is derived primarily from clients in the pharmaceutical and
biotechnology industries. Two of our partners, AstraZeneca AB and UCB Pharma,
represented 35% and 17%, respectively, of our total revenue during the year
ended December 31, 2009. Four of our partners, Bayer (including Bayer
Healthcare LLC and Bayer Schering Pharma AG), UCB Pharma, Novartis, and Roche
represented 24%, 16%, 15%, and 14%, respectively, of our total revenue during
the year ended December 31, 2008. Due to the termination of our collaborative
agreements with Pfizer, Inc., we did not receive any revenue from Pfizer, Inc.
in 2008 or 2009 related to Exubera or NGI. Revenue from Pfizer, Inc. represented
69% of our revenue for the year ended December 31, 2007.
Revenue
by geographic area is based on the locations of our partners. The following
table sets forth revenue by geographic area (in thousands):
Years ended December 31,
|
||||||||||||
2009
|
2008
|
2007
|
||||||||||
United
States
|
$ | 29,511 | $ | 30,800 | $ | 212,990 | ||||||
European
countries
|
42,420 | 59,385 | 60,037 | |||||||||
Total
revenue
|
$ | 71,931 | $ | 90,185 | $ | 273,027 |
At
December 31, 2009, approximately $64.5 million, or approximately 82%, of the net
book value of our property and equipment of $78.3 million was located in the
United States and $13.8 million, or approximately 18%, was located in
India. At December 31, 2008, $69.2 million, or approximately 94%, of
the net book value of our property and equipment was located in the United
States and $4.4 million, or approximately 6%, was located in India.
81
Note
17—Selected Quarterly Financial Data (Unaudited)
The
following table sets forth certain unaudited quarterly financial data. In our
opinion, the unaudited information set forth below has been prepared on the same
basis as the audited information and includes all adjustments necessary to
present fairly the information set forth herein. We have experienced
fluctuations in our quarterly results. We expect these fluctuations to continue
in the future. Due to these and other factors, we believe that
quarter-to-quarter comparisons of our operating results will not be meaningful,
and you should not rely on our results for any one quarter as an indication of
our future performance. Certain items previously reported in specific financial
statement captions have been reclassified to conform to the current period
presentation. Such reclassifications have not impacted previously reported
revenues, operating loss or net loss. All data is in thousands except per share
information.
Fiscal Year 2009
|
Fiscal Year 2008
|
|||||||||||||||||||||||||||||||
Q1
|
Q2
|
Q3
|
Q4
|
Q1
|
Q2
|
Q3
|
Q4
|
|||||||||||||||||||||||||
Product
sales and royalty revenue
|
$ | 6,470 | $ | 10,525 | $ | 7,461 | $ | 10,832 | $ | 10,371 | $ | 9,010 | $ | 9,474 | $ | 12,400 | ||||||||||||||||
License,
collaboration and other revenue
|
$ | 3,241 | $ | 2,463 | $ | 2,762 | $ | 28,177 | $ | 9,621 | $ | 11,392 | $ | 11,965 | $ | 15,952 | ||||||||||||||||
Gross
margin on product sales
|
$ | 844 | $ | 146 | $ | 1,327 | $ | 2,023 | $ | 3,144 | $ | 3,566 | $ | 4,125 | $ | 2,204 | ||||||||||||||||
Research
and development expenses
|
$ | 23,363 | $ | 24,002 | $ | 23,031 | $ | 24,713 | $ | 37,373 | $ | 33,500 | $ | 38,265 | $ | 45,279 | ||||||||||||||||
General
and administrative expenses
|
$ | 11,020 | $ | 9,087 | $ | 9,917 | $ | 10,982 | $ | 11,947 | $ | 13,329 | $ | 12,386 | $ | 13,835 | ||||||||||||||||
Impairment
of long lived assets
|
$ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 1,458 | ||||||||||||||||
Gain
on sale of pulmonary assets
|
$ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | (69,572 | ) | |||||||||||||||
Operating
(loss) income
|
$ | (30,298 | ) | $ | (30,480 | ) | $ | (28,859 | ) | $ | (5,495 | ) | $ | (41,889 | ) | $ | (33,358 | ) | $ | (34,561 | ) | $ | 27,156 | |||||||||
Interest
expense
|
$ | 3,337 | $ | 2,948 | $ | 2,928 | $ | 2,963 | $ | 3,918 | $ | 3,929 | $ | 3,988 | $ | 3,357 | ||||||||||||||||
Gain
on extinguishment of debt
|
$ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | — | $ | 50,149 | ||||||||||||||||
Net
(loss) income
|
$ | (31,807 | ) | $ | (32,069 | ) | $ | (30,967 | ) | $ | (7,676 | ) | $ | (40,705 | ) | $ | (33,375 | ) | $ | (37,038 | ) | $ | 76,782 | |||||||||
Basic
and diluted net income (loss) per share (1)(2)
|
$ | (0.34 | ) | $ | (0.35 | ) | $ | (0.33 | ) | $ | (0.08 | ) | $ | (0.44 | ) | $ | (0.36 | ) | $ | (0.40 | ) | $ | 0.83 |
(1)
|
Quarterly
loss per share amounts may not total to the year-to-date loss per share
due to rounding.
|
(2)
|
During
the fourth quarter of 2008, there were approximately 81 dilutive shares
outstanding.
|
82
SCHEDULE
II
NEKTAR
THERAPEUTICS
VALUATION
AND QUALIFYING ACCOUNTS AND RESERVES
YEARS
ENDED DECEMBER 31, 2009, 2008, and 2007
Description
|
Balance at
Beginning
of Year
|
Charged to
Costs and
Expenses,
Net of Reversals
|
Utilizations
|
Balance At
End
of Year
|
||||||||||||
(In
thousands)
|
||||||||||||||||
2009:
|
||||||||||||||||
Allowance
for doubtful accounts
|
$ | 92 | $ | — | $ | (92 | ) | $ | — | |||||||
Allowance
for inventory reserves
|
$ | 4,989 | $ | 2,109 | $ | (3,762 | ) | $ | 3,336 | |||||||
2008:
|
||||||||||||||||
Allowance
for doubtful accounts
|
$ | 33 | $ | 61 | $ | (2 | ) | $ | 92 | |||||||
Allowance
for inventory reserves
|
$ | 5,772 | $ | 2,668 | $ | (3,451 | ) | $ | 4,989 | |||||||
2007:
|
||||||||||||||||
Allowance
for doubtful accounts
|
$ | 357 | $ | (16 | ) | $ | (308 | ) | $ | 33 | ||||||
Allowance
for inventory reserves
|
$ | 4,160 | $ | 4,670 | $ | (3,058 | ) | $ | 5,772 |
83
Item 9. Changes in and Disagreements
with Accountants on Accounting and Financial
Disclosure
Not
applicable.
Item
9A. Controls and Procedures
Disclosure
Controls and Procedures
We
maintain disclosure controls and procedures that are designed to ensure that
information required to be disclosed in our Securities Exchange Act reports is
recorded, processed, summarized and reported within the time periods specified
in the SEC’s rules and forms, and that such information is accumulated and
communicated to management, including our Chief Executive Officer and Chief
Financial Officer, as appropriate, to allow timely decisions regarding required
financial disclosure.
As of the
end of the period covered by this report, we carried out an evaluation, under
the supervision and with the participation of our management, including the
Chief Executive Officer and the Chief Financial Officer, of the effectiveness of
the design and operation of our disclosure controls and procedures pursuant to
Exchange Act Rule 13a-15. Based upon, and as of the date of, this evaluation,
the Chief Executive Officer and the Chief Financial Officer concluded that our
disclosure controls and procedures were effective. Accordingly, management
believes that the financial statements included in this report fairly present in
all material respects our financial condition, results of operations and
cashflows for the periods presented.
Management’s
Annual Report on Internal Control over Financial Reporting
Our
management is responsible for establishing and maintaining adequate internal
control over financial reporting, as such term is defined in Exchange Act Rule
13a-15(f). Our internal control over financial reporting is a process designed
to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance
with GAAP.
Our
management has assessed the effectiveness of our internal control over financial
reporting as of December 31, 2009. In making its assessment of internal control
over financial reporting, management used the criteria described in Internal Control—Integrated
Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission.
Based on
our evaluation under the framework described in Internal Control—Integrated Framework,
our management concluded that our internal control over financial reporting was
effective as of December 31, 2009.
The
effectiveness of our internal control over financial reporting as of December
31, 2009 has been audited by an independent registered public accounting firm,
as stated in their report, which is included herein.
Changes
in Internal Control Over Financial Reporting
We
continuously seek to improve the efficiency and effectiveness of our internal
controls. This results in refinements to processes throughout the
Company. There was no change in our internal control over financial
reporting during the quarter ended December 31, 2009, which was identified in
connection with our management’s evaluation required by Exchange Act Rules
13a-15(f) and 15d-15(f) that has materially affected, or is reasonably likely to
materially affect, our internal control over financial reporting.
Inherent
Limitations on the Effectiveness of Controls
Our
management, including the Chief Executive Officer and Chief Financial Officer,
does not expect that our disclosure controls and procedures or our internal
control over financial reporting will prevent all error and all fraud. A control
system, no matter how well conceived and operated, can provide only reasonable,
not absolute, assurance that the objectives of the control system are met.
Because of the inherent limitations in all control systems, no evaluation of
controls can provide absolute assurance that all control issues and instances of
fraud, if any, within the company have been detected. These inherent limitations
include the realities that judgments in decision making can be faulty and that
breakdowns can occur because of simple error or mistake. Additionally, controls
can be circumvented by the individual acts of some persons, by collusion of two
or more people or by management override of the control. The design of any
system of controls also is based in part upon certain assumptions about the
likelihood of future events, and there can be no assurance that any design will
succeed in achieving its stated goals under all potential future conditions.
Over time, controls may become inadequate because of changes in conditions, or
the degree of compliance with the policies or procedures may deteriorate.
Because of the inherent limitations in a cost-effective control system,
misstatements due to error or fraud may occur and not be
detected.
84
Item 9B. Other
Information
None.
85
PART
III
Item
10. Directors, Executive Officers and Corporate Governance
Information
relating to our executive officers required by this item is set forth in Part
I—Item 1 of this report under the caption “Executive Officers of the Registrant”
and is incorporated herein by reference. The other information required by this
Item is incorporated by reference from the definitive proxy statement for our
2010 Annual Meeting of Stockholders to be filed with the SEC pursuant to
Regulation 14A (Proxy Statement) not later than 120 days after the end of the
fiscal year covered by this Form 10-K under the captions “Corporate Governance
and Board of Directors,” “Proposal 1—Election of
Directors” and “Section 16(a) Beneficial Ownership Reporting
Compliance.”
Information
regarding our audit committee financial expert will be set forth in the Proxy
Statement under the caption “Audit Committee,” which information is incorporated
herein by reference.
In
December 2003, we adopted a Code of Business Conduct and Ethics applicable to
all employees, including the principal executive officer, principal financial
officer and principal accounting officer or controller, or persons performing
similar functions. The Code of Business Conduct and Ethics is posted on our
website at www.nektar.com. Amendments
to, and waivers from, the Code of Business Conduct and Ethics that apply to any
of these officers, or persons performing similar functions, and that relate to
any element of the code of ethics definition enumerated in Item 406(b) of
Regulation S-K will be disclosed at the website address provided above and, to
the extent required by applicable regulations, on a current report on Form
8-K.
As
permitted by SEC Rule 10b5-1, certain of our executive officers, directors and
other employees have set up a predefined, structured stock trading program with
their broker to sell our stock. The stock trading program allows a broker acting
on behalf of the executive officer, director or other employee to trade our
stock during blackout periods or while such executive officer, director or other
employee may be aware of material, nonpublic information, if the trade is
performed according to a pre-existing contract, instruction or plan that was
established with the broker during a non-blackout period and when such executive
officer, director or employee was not aware of any material, nonpublic
information. Our executive officers, directors and other employees may also
trade our stock outside of the stock trading programs set up under Rule 10b5-1
subject to our blackout periods and insider trading rules.
Item
11. Executive Compensation
The
information required by this Item is included in the Proxy Statement and
incorporated herein by reference.
Item 12. Security Ownership of
Certain Beneficial Owners and Management and Related Stockholder
Matters
The
information required by this Item is included in the Proxy Statement and
incorporated herein by reference.
Item 13. Certain Relationships and
Related Transactions and Director Independence
The
information required by this Item is included in the Proxy Statement and
incorporated herein by reference.
Item
14. Principal Accountant Fees and Services
The
information required by this Item is included in the Proxy Statement and
incorporated herein by reference.
86
PART
IV
Item
15. Exhibits, Financial Statement Schedules
|
(a)
|
The
following documents are filed as part of this
report:
|
(1)
Consolidated
Financial Statements:
The
following financial statements are filed as part of this Annual Report on Form
10-K under Item 8 “Financial Statements and Supplementary Data.”
Page
|
|
Reports
of Independent Registered Public Accounting Firm
|
53
|
Consolidated
Balance Sheets at December 31, 2009 and 2008
|
55
|
Consolidated
Statements of Operations for each of the three years in the period ended
December 31, 2009
|
56
|
Consolidated
Statements of Stockholders’ Equity for each of the three years in the
period ended December 31, 2009
|
57
|
Consolidated
Statements of Cash Flows for each of the three years in the period ended
December 31, 2009
|
58
|
Notes
to Consolidated Financial Statements
|
(2)
Financial
Statement Schedules:
Schedule
II, Valuation and Qualifying
Accounts and Reserves, is filed as part of this Annual Report on Form
10-K under Item 8 “Financial
Statements and Supplementary Data”. All other financial statement schedules have
been omitted because they are not applicable, or the information required is
presented in our consolidated financial statements and notes thereto under Item
8 of this Annual Report on Form 10-K.
(3)
Exhibits.
Except as
so indicated in Exhibit 32.1, the following exhibits are filed as part of, or
incorporated by reference into, this Annual Report on Form 10-K.
Exhibit
Number
|
Description of Documents
|
|
2.1
|
(1)
|
Asset
Purchase Agreement, dated October 20, 2008, by and between Nektar
Therapeutics, a Delaware corporation, AeroGen, Inc., a Delaware
corporation and wholly-owned subsidiary of Nektar Therapeutics, Novartis
Pharmaceuticals Corporation, a Delaware corporation, and Novartis Pharma
AG, a Swiss corporation+
|
3.1
|
(2)
|
Certificate
of Incorporation of Inhale Therapeutic Systems (Delaware),
Inc.
|
3.2
|
(3)
|
Certificate
of Amendment of the Amended Certificate of Incorporation of Inhale
Therapeutic Systems, Inc.
|
3.3
|
(4)
|
Certificate
of Designation of Series A Junior Participating Preferred Stock of Nektar
Therapeutics
|
3.4
|
(5)
|
Certificate
of Designation of Series B Convertible Preferred Stock of Nektar
Therapeutics
|
3.5
|
(6)
|
Certificate
of Ownership and Merger of Nektar Therapeutics
|
3.6
|
(26)
|
Certificate
of Ownership and Merger of Nektar Therapeutics AL, Corporation with and
into Nektar Therapeutics
|
3.7
|
(7)
|
Amended
and Restated Bylaws of Nektar Therapeutics
|
4.1
|
Reference
is made to Exhibits 3.1, 3.2, 3.3, 3.4, 3.5, 3.6 and
3.7.
|
|
4.2
|
(6)
|
Specimen
Common Stock certificate
|
4.3
|
(4)
|
Rights
Agreement, dated as of June 1, 2001, by and between Nektar Therapeutics
and Mellon Investor Services LLC, as Rights
Agent
|
87
4.4
|
(4)
|
Form
of Right Certificate
|
4.5
|
(8)
|
Indenture,
dated September 28, 2005, by and between Nektar Therapeutics, as Issuer,
and J.P. Morgan Trust Company, National Association, as
Trustee
|
4.6
|
(8)
|
Registration
Right Agreement, dated as of September 28, 2005, among Nektar Therapeutics
and entities named therein
|
10.1
|
(9)
|
1994
Non-Employee Directors’ Stock Option Plan, as amended++
|
10.2
|
(10)
|
1994
Employee Stock Purchase Plan, as amended and restated++
|
10.3
|
(11)
|
2000
Non-Officer Equity Incentive Plan, as amended and
restated++
|
10.4
|
(12)
|
Form
of 2000 Non-Officer Equity Incentive Plan Stock Option Agreement
(Nonstatutory Stock Option)++
|
10.5
|
(12)
|
Form
of 2000 Non-Officer Equity Incentive Plan Stock Option Agreement
(Nonstatutory (Unapproved) Stock Option)++
|
10.6
|
(13)
|
Forms
of 2000 Non-Officer Equity Incentive Plan Restricted Stock Unit Grant
Notice and Restricted Stock Unit Agreement++
|
10.7
|
(14)
|
2000
Equity Incentive Plan, as amended and restated++
|
10.8
|
(15)
|
Form
of Stock Option Agreement under the 2000 Equity Incentive
Plan++
|
10.9
|
(13)
|
Forms
of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement
under the 2000 Equity Incentive Plan++
|
10.10
|
(16)
|
Form
of Non-Employee Director Stock Option Agreement under the 2000 Equity
Incentive Plan++
|
10.11
|
(16)
|
Form
of Non-Employee Director Restricted Stock Unit Agreement under the 2000
Equity Incentive Plan++
|
10.12
|
(16)
|
Employment
Transition and Separation Release Agreement, executed effective on
September 4, 2007, with Louis Drapeau++
|
10.13
|
(16)
|
Employment
Transition and Separation Release Agreement, executed effective on October
5, 2007, with David Johnston++
|
10.14
|
(17)
|
Amended
and Restated Compensation Plan for Non-Employee
Directors++
|
10.15
|
(11)
|
401(k)
Retirement Plan++
|
10.16
|
(26)
|
2010
Discretionary Performance-Based Incentive Compensation
Policy++
|
10.17
|
(1)
|
Amended
and Restated Change of Control Severance Benefit Plan++
|
10.18
|
(19)
|
Transition
and Retirement Agreement, dated March 13, 2006, with Ajit S.
Gill++
|
10.19
|
(20)
|
Letter
Amendment, dated October 5, 2006, with Ajit S. Gill, amending that certain
Transition and Retirement Agreement, dated March 13, 2006, with Mr.
Gill++
|
10.20
|
(1)
|
2008
Equity Incentive Plan++
|
10.21
|
(1)
|
Forms
of Stock Option Grant Notice and of Stock Option Agreement under the 2008
Equity Incentive Plan++
|
10.22
|
(1)
|
Forms
of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement
under the 2008 Equity Incentive Plan++
|
10.23
|
(21)
|
Separation
and General Release Agreement, dated November 17, 2008, with John S.
Patton++
|
88
10.24
|
(22)
|
Bonus
and General Release Agreement, dated December 27, 2008, with Nevan C.
Elam++
|
10.25
|
(16)
|
Form
of Severance Letter for executive officers of the
company++
|
10.26
|
(1)
|
Amended
and Restated Letter Agreement, executed effective on December 1, 2008,
with Howard W. Robin++
|
10.27
|
(1)
|
Amended
and Restated Letter Agreement, executed effective on December 1, 2008,
with John Nicholson++
|
10.28
|
(1)
|
Amended
and Restated Letter Agreement, executed effective on December 1, 2008,
with Bharatt M. Chowrira, Ph.D., J.D.++
|
10.29
|
(23)
|
Separation
and General Release Agreement between Nektar Therapeutics and Randall W.
Moreadith, M.D., Ph.D., dated November 23, 2009.++
|
10.30
|
(16)
|
Amended
and Restated Built-to-Suite Lease between Nektar Therapeutics and BMR-201
Industrial Road LLC, dated August 17, 2004, as amended on January 11, 2005
and July 19, 2007
|
10.31
|
(25)
|
Sublease,
dated as of September 30, 2009, by and between Pfizer Inc. and Nektar
Therapeutics.+
|
10.32
|
(24)
|
Settlement
Agreement and General Release, dated June 30, 2006, by and between The
Board of Trustees of the University of Alabama, The University of Alabama
in Huntsville, Nektar Therapeutics AL Corporation (a wholly-owned
subsidiary of Nektar Therapeutics), Nektar Therapeutics and J. Milton
Harris
|
10.33
|
(16)
|
Co-Development,
License and Co-Promotion Agreement, dated August 1, 2007, between Nektar
Therapeutics (and its subsidiaries) and Bayer Healthcare
LLC+
|
10.34
|
(18)
|
Termination
Agreement and Mutual Release, dated November 9, 2007, between Nektar
Therapeutics and Pfizer Inc.+
|
10.35
|
(1)
|
Exclusive
Research, Development, License and Manufacturing and Supply Agreement, by
and among Nektar AL Corporation, Baxter Healthcare SA, and Baxter
Healthcare Corporation, dated September 26, 2005, as
amended+
|
10.36
|
(1)
|
Exclusive
License Agreement, dated December 31, 2008, between Nektar Therapeutics, a
Delaware corporation, and Novartis Pharma AG, a Swiss
corporation+
|
10.37
|
(25)
|
License
Agreement by and between AstraZeneca AB and Nektar Therapeutics, dated
September 20, 2009.+
|
21.1
|
(26)
|
Subsidiaries
of Nektar Therapeutics
|
23.1
|
(26)
|
Consent
of Independent Registered Public Accounting Firm
|
24
|
Power
of Attorney (reference is made to the signature page)
|
|
31.1
|
(26)
|
Certification
of Nektar Therapeutics’ principal executive officer required by Rule
13a-14(a) or Rule 15d-14(a)
|
31.2
|
(26)
|
Certification
of Nektar Therapeutics’ principal financial officer required by Rule
13a-14(a) or Rule 15d-14(a)
|
32.1*
|
(26)
|
Section
1350 Certifications
|
____________
+
|
Confidential
treatment with respect to specific portions of this Exhibit has been
requested, and such portions are omitted and have been filed separately
with the SEC.
|
++
|
Management
contract or compensatory plan or
arrangement.
|
*
|
Exhibit
32.1 is being furnished and shall not be deemed to be “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended, or
otherwise subject to the liability of that section, nor shall such exhibit
be deemed to be incorporated by reference in any registration statement or
other document filed under the Securities Act of 1933, as amended, or the
Securities Exchange Act, except as otherwise stated in such
filing.
|
89
(1)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Annual
Report on Form 10-K for the year ended December 31,
2008.
|
(2)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended June 30,
1998.
|
(3)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended June 30,
2000.
|
(4)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on June 4,
2001.
|
(5)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on January 8,
2002.
|
(6)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on January 23,
2003.
|
(7)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on December 12,
2007.
|
(8)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on September 28,
2005.
|
(9)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended June 30,
1996.
|
(10)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Registration
Statement on Form S-8 (No. 333-98321), filed on August 19,
2002.
|
(11)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended June 30,
2004.
|
(12)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Registration
Statement on Form S-8 (No. 333-71936), filed on October 19, 2001, as
amended.
|
(13)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Annual
Report on Form 10-K, as amended, for the year ended December 31,
2005.
|
(14)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on June 7,
2006.
|
(15)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended September 30,
2000.
|
(16)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended September 30,
2007.
|
(17)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on December 14,
2009.
|
(18)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Annual
Report on Form 10-K for the year ended December 31,
2007.
|
(19)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K/A, filed on March 16,
2006.
|
(20)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended September 30,
2006.
|
90
(21)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on November 21,
2008.
|
(22)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on January 2,
2009.
|
(23)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on November 30,
2009.
|
(24)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended June 30,
2006.
|
(25)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended September 30,
2009.
|
(26)
|
Filed
herewith.
|
91
SIGNATURES
Pursuant
to the Securities Exchange Act of 1934, the Registrant has duly caused this
report to be signed on its behalf by the undersigned, thereunto duly authorized,
in the City of San Carlos, County of San Mateo, State of California on March 2,
2010.
By:
|
/s/ John
Nicholson
|
John
Nicholson
|
|
Senior
Vice President and Chief Financial Officer
|
|
By:
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/s/ Jillian B.
Thomsen
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Jillian B.
Thomsen
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Senior
Vice President and Chief Accounting
Officer
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92
POWER
OF ATTORNEY
KNOW ALL
PERSON BY THESE PRESENTS, that each person whose signature appears below
constitutes and appoints John Nicholson and Jillian B. Thomsen and each of them,
as his or her true and lawful attorneys-in-fact and agents, with full power of
substitution and resubstitution, for him or her and in his or her name, place
and stead, in any and all capacities, to sign any and all amendments to this
Annual Report on Form 10-K and to file the same, with all exhibits thereto and
other documents in connection therewith, with the Securities and Exchange
Commission, granting unto said attorneys-in-fact and agents and each of them,
full power and authority to do and perform each and every act and thing
requisite and necessary to be done in connection therewith, as fully to all
intents and purposes as he or she might or could do in person, hereby ratify and
confirming all that said attorneys-in-fact and agents, or any of them, or their
or his or her substitute or substitutes, may lawfully do or cause to be done by
virtue hereof.
Pursuant
to the requirements of the Securities Exchange Act of 1934, as amended, this
report has been signed by the following persons in the capacities and on the
dates indicated:
SIGNATURE
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TITLE
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DATE
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||
/s/ Howard W.
Robin
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Chief
Executive Officer, President and Director
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March
2, 2010
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||
Howard
W. Robin
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(Principal
Executive Officer)
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|||
/s/ John
Nicholson
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Senior
Vice President and Chief Financial
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March
2, 2010
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||
John
Nicholson
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Officer
(Principal Financial Officer)
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|||
/s/ Jillian B.
Thomsen
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Senior
Vice President Finance and Chief
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|||
Jillian
B. Thomsen
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Accounting
Officer (Principal Accounting Officer)
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March
2, 2010
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||
/s/ Robert B.
Chess
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Director,
Chairman of the Board of Directors
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March
2, 2010
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||
Robert
B. Chess
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||||
/s/ R. Scott
Greer
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Director
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March
2, 2010
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||
R.
Scott Greer
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||||
/s/ Joseph J.
Krivulka
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Director
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March
2, 2010
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||
Joseph
J. Krivulka
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||||
/s/ Christopher A.
Kuebler
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Director
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March
2, 2010
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||
Christopher
A. Kuebler
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||||
/s/ Lutz
Lingnau
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Director
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March
2, 2010
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||
Lutz
Lingnau
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||||
/s/ Susan
Wang
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Director
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March
2, 2010
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||
Susan
Wang
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||||
/s/ Roy A.
Whitfield
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Director
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March
2, 2010
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||
Roy
A. Whitfield
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||||
/s/ Dennis L.
Winger
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Director
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March
2, 2010
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||
Dennis
L. Winger
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93
Except as
so indicated in Exhibit 32.1, the following exhibits are filed as part of, or
incorporated by reference into, this Annual Report on Form 10-K.
Exhibit
Number
|
Description of Documents
|
|
2.1
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(1)
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Asset
Purchase Agreement, dated October 20, 2008, by and between Nektar
Therapeutics, a Delaware corporation, AeroGen, Inc., a Delaware
corporation and wholly-owned subsidiary of Nektar Therapeutics, Novartis
Pharmaceuticals Corporation, a Delaware corporation, and Novartis Pharma
AG, a Swiss corporation+
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3.1
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(2)
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Certificate
of Incorporation of Inhale Therapeutic Systems (Delaware),
Inc.
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3.2
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(3)
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Certificate
of Amendment of the Amended Certificate of Incorporation of Inhale
Therapeutic Systems, Inc.
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3.3
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(4)
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Certificate
of Designation of Series A Junior Participating Preferred Stock of Nektar
Therapeutics
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3.4
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(5)
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Certificate
of Designation of Series B Convertible Preferred Stock of Nektar
Therapeutics
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3.5
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(6)
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Certificate
of Ownership and Merger of Nektar Therapeutics
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3.6
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(26)
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Certificate
of Ownership and Merger of Nektar Therapeutics AL, Corporation with and
into Nektar Therapeutics
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3.7
|
(7)
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Amended
and Restated Bylaws of Nektar Therapeutics
|
4.1
|
Reference
is made to Exhibits 3.1, 3.2, 3.3, 3.4, 3.5, 3.6 and
3.7
|
|
4.2
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(6)
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Specimen
Common Stock certificate
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4.3
|
(4)
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Rights
Agreement, dated as of June 1, 2001, by and between Nektar Therapeutics
and Mellon Investor Services LLC, as Rights Agent
|
4.4
|
(4)
|
Form
of Right Certificate
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4.5
|
(8)
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Indenture,
dated September 28, 2005, by and between Nektar Therapeutics, as Issuer,
and J.P. Morgan Trust Company, National Association, as
Trustee
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4.6
|
(8)
|
Registration
Right Agreement, dated as of September 28, 2005, among Nektar Therapeutics
and entities named therein
|
10.1
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(9)
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1994
Non-Employee Directors’ Stock Option Plan, as amended++
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10.2
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(10)
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1994
Employee Stock Purchase Plan, as amended and restated++
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10.3
|
(11)
|
2000
Non-Officer Equity Incentive Plan, as amended and
restated++
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10.4
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(12)
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Form
of 2000 Non-Officer Equity Incentive Plan Stock Option Agreement
(Nonstatutory Stock Option)++
|
10.5
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(12)
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Form
of 2000 Non-Officer Equity Incentive Plan Stock Option Agreement
(Nonstatutory (Unapproved) Stock Option)++
|
10.6
|
(13)
|
Forms
of 2000 Non-Officer Equity Incentive Plan Restricted Stock Unit Grant
Notice and Restricted Stock Unit Agreement++
|
10.7
|
(14)
|
2000
Equity Incentive Plan, as amended and restated++
|
10.8
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(15)
|
Form
of Stock Option Agreement under the 2000 Equity Incentive
Plan++
|
10.9
|
(13)
|
Forms
of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement
under the 2000 Equity Incentive Plan++
|
10.10
|
(16)
|
Form
of Non-Employee Director Stock Option Agreement under the 2000 Equity
Incentive
Plan++
|
94
10.11
|
(16)
|
Form
of Non-Employee Director Restricted Stock Unit Agreement under the 2000
Equity Incentive Plan++
|
10.12
|
(16)
|
Employment
Transition and Separation Release Agreement, executed effective on
September 4, 2007, with Louis Drapeau++
|
10.13
|
(16)
|
Employment
Transition and Separation Release Agreement, executed effective on October
5, 2007, with David Johnston++
|
10.14
|
(17)
|
Amended
and Restated Compensation Plan for Non-Employee
Directors++
|
10.15
|
(11)
|
401(k)
Retirement Plan++
|
10.16
|
(26)
|
2010
Discretionary Performance-Based Incentive Compensation
Policy++
|
10.17
|
(1)
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Amended
and Restated Change of Control Severance Benefit Plan++
|
10.18
|
(19)
|
Transition
and Retirement Agreement, dated March 13, 2006, with Ajit S.
Gill++
|
10.19
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(20)
|
Letter
Amendment, dated October 5, 2006, with Ajit S. Gill, amending that certain
Transition and Retirement Agreement, dated March 13, 2006, with Mr.
Gill++
|
10.20
|
(1)
|
2008
Equity Incentive Plan++
|
10.21
|
(1)
|
Forms
of Stock Option Grant Notice and of Stock Option Agreement under the 2008
Equity Incentive Plan++
|
10.22
|
(1)
|
Forms
of Restricted Stock Unit Grant Notice and Restricted Stock Unit Agreement
under the 2008 Equity Incentive Plan++
|
10.23
|
(21)
|
Separation
and General Release Agreement, dated November 17, 2008, with John S.
Patton++
|
10.24
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(22)
|
Bonus
and General Release Agreement, dated December 27, 2008, with Nevan C.
Elam++
|
10.25
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(16)
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Form
of Severance Letter for executive officers of the
company++
|
10.26
|
(1)
|
Amended
and Restated Letter Agreement, executed effective on December 1, 2008,
with Howard W. Robin++
|
10.27
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(1)
|
Amended
and Restated Letter Agreement, executed effective on December 1, 2008,
with John Nicholson++
|
10.28
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(1)
|
Amended
and Restated Letter Agreement, executed effective on December 1, 2008,
with Bharatt M. Chowrira, Ph.D., J.D.++
|
10.29
|
(23)
|
Separation
and General Release Agreement between Nektar Therapeutics and Randall W.
Moreadith, M.D., Ph.D., dated November 23, 2009.++
|
10.30
|
(16)
|
Amended
and Restated Built-to-Suite Lease between Nektar Therapeutics and BMR-201
Industrial Road LLC, dated August 17, 2004, as amended on January 11, 2005
and July 19, 2007
|
10.31
|
(25)
|
Sublease,
dated as of September 30, 2009, by and between Pfizer Inc. and Nektar
Therapeutics.+
|
10.32
|
(24)
|
Settlement
Agreement and General Release, dated June 30, 2006, by and between The
Board of Trustees of the University of Alabama, The University of Alabama
in Huntsville, Nektar Therapeutics AL Corporation (a wholly-owned
subsidiary of Nektar Therapeutics), Nektar Therapeutics and J. Milton
Harris
|
10.33
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(16)
|
Co-Development,
License and Co-Promotion Agreement, dated August 1, 2007, between Nektar
Therapeutics (and its subsidiaries) and Bayer Healthcare
LLC+
|
10.34
|
(18)
|
Termination
Agreement and Mutual Release, dated November 9, 2007, between Nektar
Therapeutics and Pfizer Inc.+
|
10.35
|
(1)
|
Exclusive
Research, Development, License and Manufacturing and Supply Agreement, by
and among Nektar AL Corporation, Baxter Healthcare SA, and Baxter
Healthcare Corporation, dated September 26, 2005, as
amended+
|
95
10.36
|
(1)
|
Exclusive
License Agreement, dated December 31, 2008, between Nektar Therapeutics, a
Delaware corporation, and Novartis Pharma AG, a Swiss
corporation+
|
10.37
|
(25)
|
License
Agreement by and between AstraZeneca AB and Nektar Therapeutics, dated
September 20, 2009.+
|
21.1
|
(26)
|
Subsidiaries
of Nektar Therapeutics
|
23.1
|
(26)
|
Consent
of Independent Registered Public Accounting Firm
|
24
|
Power
of Attorney (reference is made to the signature page)
|
|
31.1
|
(26)
|
Certification
of Nektar Therapeutics’ principal executive officer required by Rule
13a-14(a) or Rule 15d-14(a)
|
31.2
|
(26)
|
Certification
of Nektar Therapeutics’ principal financial officer required by Rule
13a-14(a) or Rule 15d-14(a)
|
32.1*
|
(26)
|
Section
1350
Certifications
|
____________
+
|
Confidential
treatment with respect to specific portions of this Exhibit has been
requested, and such portions are omitted and have been filed separately
with the SEC.
|
++
|
Management
contract or compensatory plan or
arrangement.
|
*
|
Exhibit
32.1 is being furnished and shall not be deemed to be “filed” for purposes
of Section 18 of the Securities Exchange Act of 1934, as amended, or
otherwise subject to the liability of that section, nor shall such exhibit
be deemed to be incorporated by reference in any registration statement or
other document filed under the Securities Act of 1933, as amended, or the
Securities Exchange Act, except as otherwise stated in such
filing.
|
(1)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Annual
Report on Form 10-K for the year ended December 31,
2008.
|
(2)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended June 30,
1998.
|
(3)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended June 30,
2000.
|
(4)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on June 4,
2001.
|
(5)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on January 8,
2002.
|
(6)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on January 23,
2003.
|
(7)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on December 12,
2007.
|
(8)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on September 28,
2005.
|
(9)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended June 30,
1996.
|
(10)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Registration
Statement on Form S-8 (No. 333-98321), filed on August 19,
2002.
|
96
(11)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended June 30,
2004.
|
(12)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Registration
Statement on Form S-8 (No. 333-71936), filed on October 19, 2001, as
amended.
|
(13)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Annual
Report on Form 10-K, as amended, for the year ended December 31,
2005.
|
(14)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on June 7,
2006.
|
(15)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended September 30,
2000.
|
(16)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended September 30,
2007.
|
(17)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on December 14,
2009.
|
(18)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Annual
Report on Form 10-K for the year ended December 31,
2007.
|
(19)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K/A, filed on March 16,
2006.
|
(20)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended September 30,
2006.
|
(21)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on November 21,
2008.
|
(22)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on January 2,
2009.
|
(23)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Current
Report on Form 8-K, filed on November 30,
2009.
|
(24)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended June 30,
2006.
|
(25)
|
Incorporated
by reference to the indicated exhibit in Nektar Therapeutics’ Quarterly
Report on Form 10-Q for the quarter ended September 30,
2009.
|
(26)
|
Filed
herewith.
|
97