PLUS THERAPEUTICS, INC. - Annual Report: 2007 (Form 10-K)
UNITED
STATES SECURITIES AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
10-K
(Mark
One)
|
||
ý
|
ANNUAL
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
|
For
the fiscal year ended December 31, 2007
|
||
OR
|
||
o
|
TRANSITION
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
|
|
For
the transition period
from to
|
||
Commission
file number 0-32501
|
CYTORI
THERAPEUTICS, INC.
(Exact
name of Registrant as Specified in Its Charter)
DELAWARE
|
33-0827593
|
|
(State
or Other Jurisdiction
of
Incorporation or Organization)
|
(I.R.S.
Employer
Identification
No.)
|
|
3020
CALLAN ROAD, SAN DIEGO, CALIFORNIA
|
92121
|
|
(Address
of principal executive offices)
|
(Zip
Code)
|
Registrant’s
telephone number, including area code: (858) 458-0900
Securities
registered pursuant to Section 12(b) of the Act:
Common
stock, par value $0.001
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 o No ý
Indicate
by check mark if the registrant is not required to file reports pursuant to
Section 13 or Section 15(d) of the Exchange Act.
Yes o No ý
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 ý No o
Indicate
by check mark if disclosure of delinquent filers pursuant to Item 405 of
Regulation S-K is not contained herein, and will not be contained, to the best
of the 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. ý
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 definition of “large accelerated filer,” “accelerated
filer” and “smaller reporting company” in Rule 12b-2 of the Exchange Act
(Check one).
Large
Accelerated Filer o
|
Accelerated
Filer ý
|
Non-Accelerated
Filer o
|
Smaller
reporting company o
|
(Do
not check if a smaller reporting company)
|
Indicate
by check mark whether the registrant is a shell company (as defined in Rule
12b-2 of the Exchange Act).
Yes o No ý
The
aggregate market value of the common stock of the registrant held by
non-affiliates of the registrant on June 30, 2007, the last business day of the
registrant’s most recently completed second fiscal quarter, was $96,238,365
based on the closing sales price of the registrant’s common stock on June 30,
2007 as reported on the Nasdaq Global Market, of $5.75 per share.
As of
February 29, 2008, there were 25,103,898 shares of the registrant’s common stock
outstanding.
DOCUMENTS
INCORPORATED BY REFERENCE
Portions
of the registrant’s definitive proxy statement for the 2008 Annual Meeting of
Stockholders, which will be filed with the Securities and Exchange Commission
within 120 days after the end of the year ended December 31, 2007, are
incorporated by reference in Part III, Items 10, 11, 12, 13 and 14 of this Form
10-K.
TABLE
OF CONTENTS
|
||
PART
I
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
PART
II
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
|
||
PART
III
|
||
|
||
|
||
|
||
|
||
|
||
PART
IV
|
||
|
2
PART I
Item 1. Business
General
Cytori
Therapeutics, Inc., develops, manufactures, and sells medical technologies to
enable the practice of regenerative medicine. Regenerative medicine describes
the emerging field that aims to repair or restore lost or damaged organ and cell
function. Our commercial activities are currently focused on reconstructive
surgery in Europe and Asia-Pacific and stem and regenerative cell banking (cell
preservation) in Japan. In addition, we are seeking to bring our
products to market in the United States as well as other countries. Our product
pipeline includes the development of potential new treatments for cardiovascular
disease, orthopedic damage, gastrointestinal disorders, and pelvic health
conditions.
The
foundation of our business is the Celution™ System family of products (600, 700,
800, 900/MB & next generation Celution™ device), which processes patients'
cells at the bedside in real time. Each member of the Celution™ System family of
products consists of a central device, a related single-use consumable used for
each patient procedure, and supportive procedural components. Our
commercialization model is based on the sale of Celution™ Systems and on
generating recurring revenues from the single-use consumable sets.
Our
Celution™ 800/CRS System was introduced during 2008 into the European
reconstructive surgery market through a network of medical distributors. The
Celution™ 900/MB is being marketed in Japan through our commercialization
partner, Green Hospital Supply, Inc. (Green Hospital Supply) as part of the
comprehensive StemSource™ Cell Bank, which prepares cells for cryopreservation
in the event they may be used in the future.
The most
advanced therapeutic application in our product development pipeline is
cardiovascular disease. Currently, two clinical trials are being conducted on
adipose-derived stem and regenerative cells, processed with the Celution™ 600
System, an earlier version of the CelutionTM 800/CV.
One is in patients suffering from chronic myocardial ischemia, a severe form of
chronic heart disease, and the other in heart attack patients. Future
cardiovascular disease studies in Europe will use the Celution™ 800 or next
generation Celution™ device.
In the
United States, we will seek regulatory and marketing approval on the Celution™
700 System for a variety of applications, starting with reconstructive surgery
to enhance autologous soft tissue transplantations. U.S. approval is estimated
to be achieved at the earliest in 2009, pending positive outcome of planned
regulatory submissions and/or clinical trials. In the future, we expect to begin
clinical studies around the world on our own or through potential corporate
partners in the areas of spinal disc repair, gastrointestinal disorders, and
pelvic health conditions.
Summary
of CelutionTM System
Family Regulatory Status
Celution™
Series
|
Region
|
Clinical
Applications
|
Regulatory
Status
|
Comments
|
900/MB
|
Japan
|
Cell
Banking
|
Approved
|
|
800/CRS
|
Europe
|
Cell
Processing
|
CE
Mark
|
Post-marketing
studies planned for reconstructive surgery
|
Singapore
|
Cell
Processing
|
Approved
|
In
registration
|
|
800/CV
|
Europe
|
Will
seek cardiovascular disease claims
|
None
|
|
800/GP
|
Europe
|
Will
seek multiple general surgical claims
|
None | |
700/CRS
|
USA
|
Will
seek reconstructive surgery claims
|
None
|
|
700/CV
|
USA
|
Will
seek cardiovascular disease claims
|
None
|
|
700/GP
|
USA
|
Will
seek multiple general surgical claims
|
None |
3
Summary
of CelutionTM System
Family Regulatory Status (continued)
Celution™
Series
|
Region
|
Clinical
Applications
|
Regulatory
Status
|
Comments
|
600
|
Europe
|
Cell
Concentration
|
CE
Mark
|
Two
cardiac clinical trials underway: chronic and acute
|
300
|
USA
|
Blood
Processing
|
None
|
Our
MacroPore Biosurgery operating segment manages the ThinFilm biomaterial product
line in Japan. We sold our non-Japan Thin Film business in 2004. Pending
regulatory approval in Japan, this product line would be distributed exclusively
through Senko Medical Trading Co. (“Senko”) for anti-adhesion applications, soft
tissue support, and minimization of the attachment of soft tissues throughout
the body.
Reconstructive
Surgery
The
Celution™ 800/CRS System is approved in Europe as a bedside device for
separating and concentrating a patient's stem and regenerative cells, which
reside naturally within their adipose (fat) tissue, so that these cells may be
re-injected back into that same patient in the same surgical procedure.
Scientific evidence suggests that adipose-derived stem and regenerative cells
support tissue and graft survival when redistributed from one part of the body
to another in their unaltered state.
The
Celution™ 800/CRS System was introduced into the European and Asia-Pacific
reconstructive surgery market in the first quarter of 2008. This
year, we will initially target select surgeons and hospitals in these regions
for general use in cosmetic and reconstructive surgery. Our distribution
network currently covers Belgium, China, Greece, Israel, Italy, Korea,
Luxembourg, Malaysia, Portugal, Singapore, Spain, Taiwan, and The Netherlands.
We anticipate expanding the network in 2008 to include Germany, the United
Kingdom, and other countries.
We expect
to begin commercializing the Celution™ 800/CRS System for more specific
applications such as breast reconstruction for partial mastectomy defects as
early as 2009 pending supporting clinical data. To support this goal, we
plan to initiate two European clinical trials in 2008. One will be a 70-patient,
multi-center study and the other a 20-patient, single center study in patients
with more severe radiation damage. The results from these studies will also be
used to support reimbursement for such a procedure.
There are
an estimated 370,000 patients in Europe diagnosed each year with breast cancer,
of which approximately 75% are eligible to undergo partial mastectomy. Based on
this figure and the survival rate for breast cancer patients, there are already
millions of women in Europe who have been treated for breast cancer, for which a
percentage could be eligible for partial mastectomy defect
reconstruction.
StemSource™ Cell Bank
The
Celution™ 900/MB System is the foundation of our StemSource™ Cell Bank
for cryopreserving patients’ adult stem and regenerative cells. The
StemSource™ Cell Bank will be marketed to hospitals in Japan exclusively by
Green Hospital Supply, Inc., starting in 2008. With a StemSource™ Cell Bank on
site, hospitals will be able to offer their patients the option of storing their
adipose tissue-derived stem and regenerative cells and accessing them as
clinical applications are approved.
The value
of a StemSource™ Cell Bank is that it is intended to provide hospitals recurring
revenue from processing, freezing, and the annual storage fees. It starts with a
tissue collection procedure, which may be performed during an already planned
surgery or a separate elective procedure. The cells are prepared for storage
using the Celution™ 900/MB System, which automates the separation and
concentration of stem and regenerative cells from adipose tissue and thereby
allows hospitals to more affordably offer such service to patients.
As part
of our agreement with Green Hospital Supply, we equally split revenues in Japan
from the sale to hospitals of StemSource™ Cell Banks and single-use,
per-procedure consumables. Green Hospital Supply is responsible for all sales
and marketing while Cytori is responsible for manufacturing the Celution™ 900/MB
System and sourcing all necessary equipment, including but not limited to
cryopreservation chambers, cooling and thawing devices, cell banking protocols
and the proprietary software and database application.
4
We have
retained rights to commercialize the Celution™ 900-based StemSource™ Cell Bank
in other countries as our relationship with Green Hospital Supply is exclusively
for Japan. We are making plans to offer the StemSource™ Cell Banking in the U.S.
starting in 2008. For the U.S. market, the storage of cells will likely occur in
a more centralized manner, rather than at the local level in hospitals, and will
be targeted primarily toward patients undergoing elective
liposuction.
Cardiovascular
Disease
We
currently have two clinical trials underway for adipose-derived stem and
regenerative cells, processed with the Celution™ 600 System, for the treatment
of cardiovascular disease. In January 2007, we initiated a 36-patient clinical
trial for chronic myocardial ischemia, a severe form of coronary artery disease.
In late 2007, we initiated a 48-patient study for acute heart
attacks. Both are double-blind, placebo controlled safety and
feasibility studies, which will evaluate a variety of primary and secondary
safety and efficacy endpoints at six months.
We
believe there is significant need for new forms of treatment for cardiovascular
disease, which represents one of the largest healthcare market opportunities.
The American Heart Association estimates that in the United States of America
alone there are approximately 865,000 heart attacks each year and more than
13,000,000 people suffer from coronary heart disease.
Celution™ System
Pipeline
Other
applications of the Celution™ System family of products under investigation
include gastrointestinal disorders, vascular disease, pelvic health conditions,
and orthopedic and spinal applications. Our scientists are, to a varying degree,
investigating these applications in pre-clinical models. The full pipeline and
the relative stages of progress for all the targeted therapeutic areas are
detailed below:
Therapeutic
Application
|
Preclinical
|
Clinical
Testing
|
Notes
|
|
Reconstructive
Surgery
|
||||
Breast
reconstruction
|
X
|
EU
post-marketing studies to begin in 2008
|
||
Cardiovascular
Disease
|
||||
Chronic
Myocardial Ischemia
|
X
|
Safety
and feasibility trial underway
|
||
Heart
Attack
|
X
|
Safety
and feasibility trial underway
|
||
Gastrointestinal
Disorders
|
||||
Crohn’s
Disease
|
X
|
|||
Intestinal
Repair
|
X
|
|||
Vascular
Repair
|
||||
Peripheral
Vascular Disease
|
X
|
|||
Orthopedics
|
||||
Spinal
Disc Disease
|
X
|
Report
12-month preclinical data in 2008
|
||
Bone
Repair
|
X
|
|||
Pelvic
Health
|
X
|
Manufacturing
The
CelutionTM
800/CRS, CelutionTM 900/MB,
and related single-use consumables are being manufactured at Cytori’s
headquarters in San Diego, CA. In 2007, we completed the build out of
our internal manufacturing capabilities so that we will be able to meet
anticipated demand in 2008 and 2009.
In the
future, the next generation Celution™ device is expected to be manufactured
through a joint venture arrangement between Cytori and Olympus Corporation
(“Olympus”), a global optics and life science company. Olympus-Cytori Inc.
(the “Joint Venture”), enables Cytori to access Olympus’ expertise in
engineering, manufacturing and servicing of sophisticated medical devices.
The Joint Venture will supply the Celution™ System for all therapeutic
applications solely to Cytori at a formula-based transfer price. Cytori owns
Celution™ System marketing rights for all therapeutic applications.
Competition
We
compete with multiple pharmaceutical, biotechnology and medical device companies
involved in the development and commercialization of medical technologies and
therapies.
Regenerative
medicine is rapidly progressing, in large part through the development of
cell-based therapies or devices designed to isolate cells from human tissues.
Most efforts involve cell sources, such as bone marrow, embryonic and fetal
tissue, umbilical cord and peripheral blood, and skeletal muscle. We work
exclusively with adult stem and regenerative cells from adipose
tissue.
5
Companies
working in this area include, among others, Aastrom Biosciences, Inc., Baxter
International, Inc., BioHeart, Inc., Cellerix SA, Genzyme, Inc., Geron
Corporation, Isolagen, Inc., MG Biotherapeutics (a joint venture between Genzyme
and Medtronic), Osiris Therapeutics, Inc., and Stem Cells, Inc. Many of our
competitors and potential competitors have substantially greater financial,
technological, research and development, marketing, and personnel resources than
we do. We cannot with any accuracy forecast when or if these
companies are likely to bring cell therapies to market for indications that we
are also pursuing.
In
addition to our own sponsored clinical trials, we are aware of a clinical trial
and ongoing clinical series using cells derived from adipose tissue. The
clinical trial is sponsored by Cellerix, which is performing a study in Spain
where cultured adipose-derived stem cells are being used to treat fistulas
associated with Crohn’s disease. The clinical series is sponsored by the
University of Tokyo, where a researcher is examining the potential of
adipose-derived regenerative cells in soft tissue repair and breast tissue
augmentation. In contrast to Cytori, neither study uses an automated
system to remove cells from adipose tissue, but rather rely upon a manual
laboratory procedure. For Cellerix, the patient adipose tissue is
sent to a central processing facility where the cells are cultured over a period
of days requiring the patient to return for a separate procedure to receive
their own cells.
Companies
researching and developing cell-based therapies for cardiovascular disease
include, among others, Baxter, BioHeart, MG Biotherapeutics, and Osiris. Baxter
is sponsoring a Phase II study in the United States using stem cells extracted
from peripheral blood for chronic myocardial ischemia. BioHeart is conducting
multiple ongoing clinical trials in the United States and Europe for its
investigational product MyoCell™, which are cultured autologous skeletal
myoblasts. We are aware that BioHeart has disclosed its intentions to
develop heart attack treatments using adipose-derived stem and regenerative
cells following completion of preclinical validation, but we are not aware of
any ongoing activities in this area. Osiris Therapeutics, Inc.
completed a Phase I clinical trial using allogeneic (donor), mesenchymal stem
cells, for acute myocardial infarction and is planning a broader Phase II
study.
Our
competitive advantage among all companies developing stem cell-based therapies
is the commercialization model. Because we will rely on selling a device and
per-procedure consumables, the procedure costs will be much less than
traditional costs for biologics, yet we anticipate we will be able to realize
attractive margins. In addition, because adipose tissue is so rich in cells, we
believe that the device will allow patients to receive a prescribed dose at the
bedside in real-time, eliminating the need for patients to undergo a harvest
procedure and return for a second injection or delivery procedure. Lastly, we
believe the ideal approach to cell-based therapy is to use a patient’s own
cells, as this eliminates any risk of disease transmission or tissue
rejection.
While we
are not aware of any company that is currently commercializing any approved
treatments, devices, or therapies based on adipose-derived stem and/or
regenerative cells, there can be no assurances that such approval and related
commercialization will not be forthcoming in the near future.
Research
and Development
Research
and development expenses were $20,020,000, $21,977,000 and $15,450,000 for the
years ended December 31, 2007, 2006 and 2005, respectively. For 2007,
$19,827,000 of the total was related to our regenerative cell technology and
$193,000 was related to our bioresorbable technology.
Our
research and development efforts in 2007 focused predominantly on the following
areas:
·
|
Optimization
of the design, functionality and manufacturing process for the Celution™
System family of products, single-use consumables and related
instrumentation so we can introduce the device in Europe into the
reconstructive surgery market and provide it as part of the StemSource™
Cell Bank product being launched in
Japan;
|
·
|
Development
of the infrastructure and logistics in partnership with Green Hospital
Supply for the commercial launch of the StemSource™ Cell Bank product in
Japan, including building out a proprietary database and software
application and optimizing proprietary
protocols;
|
·
|
Design
and implementation for two randomized, double blind, placebo controlled,
cardiovascular disease clinical trials in Spain and The Netherlands for
chronic myocardial ischemia (36 patients) and heart attacks (48
patients). This includes working with regulatory bodies in the
respective countries and trial centers where the studies will be
conducted, finalizing trial protocols, and preparing the trial centers for
patient enrollment;
|
6
·
|
Preparation
and submission of multiple regulatory filings in the United States,
Europe, and Japan related to various cell processing systems under
development, which notably resulted in receipt of a CE Mark on the
Celution™ 800 System and 510(K) clearance in the United States for various
medical technologies, including a cell saver
device;
|
·
|
Conducting
extensive pre-clinical safety and efficacy studies investigating the use
of adipose-derived stem and regenerative cells for reconstructive surgery,
spinal disc repair, gastrointestinal disorders and other therapeutic
applications to optimize the design of future clinical trials and to
further our understanding of how these cells may perform
clinically;
|
·
|
Investigating
the cellular and molecular properties and characteristics of stem and
regenerative cells residing in adipose tissue towards improving our
intellectual property position and towards understanding how to improve
and control the therapeutic
products.
|
Customers
Medtronic
was our primary distributor and our principal customer for our bioresorbable
implant products, directly accounting for $792,000 or 100% of our product
revenues in 2007, $1,451,000 or 100% of our product revenues in 2006, and
$5,634,000 or 100% of our product revenues in 2005. In May 2007, we sold all of
our remaining rights to this product line to Kensey Nash Corporation and thus we
will no longer recognize bioresorbable implant product revenues from Medtronic
in the future. In our primary business (regenerative cell technology), we did
not have any commercial customers in 2007. During 2008, we intend to sell the
Celution™ 800/CRS to our various distribution partners throughout Europe and
Asia. In addition, we expect to sell Celution™ 900-based StemSource™ Cell Banks
to Green Hospital Supply, who is commercializing this product offering to
hospitals in Japan.
In July
2004, we entered into a Distribution Agreement with Senko under which we granted
to Senko an exclusive license to sell and distribute Thin Film products in
Japan. The sale of products through Senko commences upon “commercialization,”
which requires regulatory clearance from the Japanese regulatory authorities. We
expect to gain the required regulatory clearance in 2008, but we cannot make any
guarantees. Following commercialization, the Distribution Agreement has a
five-year duration and is renewable for an additional five years after reaching
mutually agreed minimum purchase guarantees. In 2004, we sold all of
our non-Japan Thin Film business.
Sales
by Geographic Region
For the
year ended December 31, 2007, our only product sales came from our bioresorbable
surgical implants. As these are no longer core to our business focus,
we sold our remaining interest in this line of business to Kensey Nash in May
2007 (excluding our Thin Film products in Japan) and we no longer receive any
revenue from the sales of those products. Prior to May 2007, we sold
our products predominantly in the United States and to a lesser extent
internationally through Medtronic. Our bioresorbable surgical
implants distribution agreements all provided for payment in U.S.
dollars. Fluctuations in currency exchange rates affected the demand
for those products by increasing the price of our products relative to the
currency of the countries in which the products were sold.
Regenerative
Cell Technology
Our
consolidated balance sheet includes a line item entitled deferred revenues,
related party. This account primarily consists of the consideration
we have received in exchange for future obligations that we have agreed to
perform on behalf of Olympus and the Joint Venture. We recognize
deferred revenues, related party, as development revenue when certain
performance obligations are met. Such revenue recognition results
from completion of certain milestones, such as completion of product development
efforts, regulatory filings and related pre-clinical and clinical
studies. In 2007 and 2006, we
recognized $5,158,000 and $5,905,000 of revenue associated with our arrangements
with Olympus, respectively. There was no similar revenue in
2005.
For the
years ended December 31, 2006 and 2005, we recorded $310,000 and $312,000 in
grant revenue related to our agreement with the National Institutes of Health
(“NIH”), respectively. Under this agreement, the NIH reimbursed us
for “qualifying expenditures” related to research on Adipose-Derived Cell
Therapy for Myocardial Infarction. There was no similar revenue for
2007.
7
For the
year ended December 31, 2007 and 2006, we recorded revenue of $85,000 and
$102,000, respectively, related to cell processing equipment, and adipose
derived stem cell research products sold to various research
facilities. We also recorded stem cell banking revenue of $4,000,
$7,000 and $8,000 for the years ended December 31, 2007, 2006, and 2005,
respectively, related to our U.S. StemSource™ Cell Bank offering for the
processing and preservation of adipose-derived stem and regenerative cells at
our FDA and California state-licensed tissue bank facility.
MacroPore
Biosurgery
In 2007,
2006, and 2005 our product sales were $792,000, $1,451,000 and $5,634,000,
respectively, all of which relate to the MacroPore Biosurgery
segment. These revenues were primarily related to orders for our
radiographically identifiable Spine System products, marketed under the name
MYSTIQUE™. As noted above, we were concerned about the level of
commitment to these products from Medtronic, our exclusive distributor, and we
have sold our intellectual property rights and tangible assets related to our
spine and orthopedic bioresorbable implant product line to Kensey Nash in May
2007.
Under a
distribution agreement with Senko, we are responsible for the completion of the
initial regulatory application to the MHLW (the Japanese equivalent of the U.S.
Food and Drug Administration). We recognized development revenue
based on milestones defined within this agreement of $10,000, $152,000, and
$51,000 for the years ended December 31, 2007, 2006, and 2005,
respectively. We have not received any Thin Film product revenue in
Japan yet, and we sold all our non-Japan Thin Film business in
2004.
We
anticipate that our future international product revenues will increase as a
result of our Distribution Agreement with Senko once our Thin Film products
reach commercialization in Japan.
Planned
Capital Expenditures
Although
capital expenditures may vary significantly depending on a variety of factors,
we presently intend to spend approximately $500,000 on capital equipment
purchases in 2008. These may be paid with our available cash, or
financed under our Amended Master Security Agreement with General Electric
Capital Corporation.
Raw
Materials
Raw
materials required to manufacture the Celution™ System family of products and
disposables are commonly available from multiple sources, and we have identified
and executed supply agreements with our preferred vendors. Some
specialty components are custom made for Cytori, and we are dependent on the
ability of these suppliers to deliver functioning parts in a timely manner to
meet our ongoing demand for our products. There can be no assurance
that we will be able to obtain adequate quantities of the necessary raw
materials supplies within a reasonable time or at commercially reasonable
prices. Interruptions in supplies due to price, timing, or
availability could have a negative impact on our ability to manufacture
products.
Intellectual
Property
Our
success depends in large part on our ability to protect our proprietary
technology, including the CelutionTM System
product platform, and information, and operate without infringing on the
proprietary rights of third parties. We rely on a combination of patent, trade
secret, copyright and trademark laws, as well as confidentiality agreements,
licensing agreements and other agreements, to establish and protect our
proprietary rights. Our success also depends, in part, on our ability to avoid
infringing patents issued to others. If we were judicially determined to be
infringing any third party patent, we could be required to pay damages, alter
our products or processes, obtain licenses or cease certain
activities.
To
protect our proprietary medical technologies, including the CelutionTM System
platform and scientific discoveries, we have filed applications for 28 United
States patents, as well as an additional 98 international patents. Specifically,
we are seeking patents on composition of matter related to adipose-derived stem
and regenerative cells, their mechanisms of action in
specific diseases, their application to specific therapeutic areas, methods for
processing these cells, and on automated systems for such processing and related
equipment.
We are
also the exclusive, worldwide licensee of the Regents of the University of
California’s rights to one U.S. Patent (Patent No. 6,777,231) related to
isolated adipose derived stem cells that can differentiate into two or more of a
variety of cell types, four related issued foreign patents, five related U.S.
patent applications, and 20 related international patent
applications.
8
We cannot
assure that any of the pending patent applications will be issued, that we will
develop additional proprietary products that are patentable, that any patents
issued to us will provide us with competitive advantages or will not be
challenged by any third parties or that the patents of others will not prevent
the commercialization of products incorporating our technology. Furthermore, we
cannot assure that others will not independently develop similar products,
duplicate any of our products or design around our patents. U.S. patent
applications are not immediately made public, so we might be surprised by the
grant to someone else of a patent on a technology we are actively
using.
Patent
law outside the United States is uncertain and in many countries is currently
undergoing review and revisions. The laws of some countries may not protect our
proprietary rights to the same extent as the laws of the U.S. Third parties may
attempt to oppose the issuance of patents to us in foreign countries by
initiating opposition proceedings. Opposition proceedings against any of our
patent filings in a foreign country could have an adverse effect on our
corresponding patents that are issued or pending in the U.S. It may be necessary
or useful for us to participate in proceedings to determine the validity of our
patents or our competitors’ patents that have been issued in countries other
than the U.S. This could result in substantial costs, divert our efforts and
attention from other aspects of our business, and could have a material adverse
effect on our results of operations and financial condition. We currently have
pending patent applications in Europe, Australia, Japan, Canada, China, Korea,
and Singapore, among others.
Patent
litigation results in substantial costs to us and diversion of effort, and may
be necessary from time to time to enforce or confirm the ownership of any
patents issued or licensed to us or to determine the scope and validity of third
party proprietary rights. If our competitors claim technology also claimed by us
and prepare and file patent applications in the United States, we may have to
participate in interference proceedings declared by the U.S. Patent and
Trademark Office or a foreign patent office to determine priority of invention,
which could result in substantial costs to and diversion of effort, even if the
eventual outcome is favorable to us. In particular, in the fourth quarter of
2004, the University of Pittsburgh filed a lawsuit naming all of the inventors
who had not assigned their ownership interest in Patent 6,777,231 to the
University of Pittsburgh, seeking a determination that its assignors, rather
than the University of California’s assignors, are the true inventors of Patent
No. 6,777,231. If the University of Pittsburgh wins the lawsuit, our license
rights to this patent could be nullified or rendered non-exclusive with respect
to any third party that might license rights from the University of Pittsburgh.
On August 9, 2007, the United States District Court granted the University of
Pittsburgh’s motion for Summary Judgment in part, determining that the
University of Pittsburgh’s assignees were properly named as inventors on Patent
6,777,231, and that all other inventorship issues shall be determined according
to the facts presented at trial which was completed in January 2008. We expect
the court to make its final ruling on all of the other matters in the first or
second quarter of 2008. We have incurred and expect to continue to incur
substantial legal costs as a result of the University of Pittsburgh lawsuit. Our
President, Marc Hedrick, M.D., is a named individual defendant in that
lawsuit.
In
addition to patent protection, we rely on unpatented trade secrets and
proprietary technological expertise. We cannot assure you that others will not
independently develop or otherwise acquire substantially equivalent techniques,
somehow gain access to our trade secrets and proprietary technological expertise
or disclose such trade secrets, or that we can ultimately protect our rights to
such unpatented trade secrets and proprietary technological expertise. We rely,
in part, on confidentiality agreements with our marketing partners, employees,
advisors, vendors and consultants to protect our trade secrets and proprietary
technological expertise. We cannot assure you that these agreements will not be
breached, that we will have adequate remedies for any breach or that our
unpatented trade secrets and proprietary technological expertise will not
otherwise become known or be independently discovered by
competitors.
Failure
to obtain or maintain patent protection, or protect trade secrets, for any
reason, third party claims against our patents, trade secrets or proprietary
rights, or our involvement in disputes over our patents, trade secrets or
proprietary rights, including involvement in litigation, could have a
substantial negative effect on the results of our operations, cash flows and
financial condition.
Government
Regulation
As newly
developed medical devices, our CelutionTM System
family of products must receive regulatory clearances or approvals from the
European Union, the FDA and, from other state governments prior to their
sale. Our current and future CelutionTM Systems
are or will be subject to stringent government regulation in the United States
by the FDA under the Federal Food, Drug and Cosmetic Act. The FDA
regulates the design/development process, clinical testing, manufacture, safety,
labeling, sale, distribution, and promotion of medical devices and
drugs. Included among these regulations are pre-market clearance and
pre-market approval requirements, design control requirements, and the Quality
System Regulations/Good Manufacturing Practices. Other statutory and
regulatory requirements govern, among other things, establishment registration
and inspection, medical device listing, prohibitions against misbranding and
adulteration, labeling and post-market reporting.
9
The
CelutionTM
System family of products must also comply with the government
regulations of each individual country in which the products are to be
distributed and sold. These regulations vary in complexity and can be as
stringent, and on occasion even more stringent, than US FDA regulations.
International government regulations vary from country to country and region to
region. For example, regulations in some parts of the world only require product
registration while other regions / countries require a complex product approval
process. Due to the fact that there are new and emerging cell therapy and cell
banking regulations that have recently been drafted and/or implemented in
various countries around the world, the application and subsequent
implementation of these new and emerging regulations have little to no
precedence. Therefore, the level of complexity and stringency is not known and
may vary from country to country, creating greater uncertainty for the
international regulatory process. Furthermore, government regulations can change
with little to no notice and may result in up-regulation of our product(s),
thereby, creating a greater regulatory burden for our cell therapy and cell
banking technology products.
The
regulatory process can be lengthy, expensive, and uncertain. Before
any new medical device may be introduced to the United States of America market,
the manufacturer generally must obtain FDA clearance or approval through either
the 510(k) pre-market notification process or the lengthier pre-market approval
application (“PMA”) process. It generally takes from three to 12
months from submission to obtain 510(k) pre-market clearance, although it may
take longer. Approval of a PMA could take four or more years from the
time the process is initiated. The 510(k) and PMA processes can be
expensive, uncertain, and lengthy, and there is no guarantee of ultimate
clearance or approval. We expect that some of our future products
under development as well as Olympus-Cytori’s will be subject to the lengthier
PMA process. Securing FDA clearances and approvals may require the
submission of extensive clinical data and supporting information to the FDA, and
there can be no guarantee of ultimate clearance or approval. Failure
to comply with applicable requirements can result in application integrity
proceedings, fines, recalls or seizures of products, injunctions, civil
penalties, total or partial suspensions of production, withdrawals of existing
product approvals or clearances, refusals to approve or clear new applications
or notifications, and criminal prosecution.
Medical
devices are also subject to post-market reporting requirements for deaths or
serious injuries when the device may have caused or contributed to the death or
serious injury, and for certain device malfunctions that would be likely to
cause or contribute to a death or serious injury if the malfunction were to
recur. If safety or effectiveness problems occur after the product
reaches the market, the FDA may take steps to prevent or limit further marketing
of the product. Additionally, the FDA actively enforces regulations
prohibiting marketing and promotion of devices for indications or uses that have
not been cleared or approved by the FDA. In addition, modifications or
enhancements of products that could affect the safety or effectiveness or effect
a major change in the intended use of a device that was either cleared through
the 510(k) process or approved through the PMA process may require further FDA
review through new 510(k) or PMA submissions.
Under the
terms of our Joint Venture Agreements with Olympus we are the party with the
primary responsibility for obtaining regulatory approvals to sell the
Olympus-Cytori, Inc. devices. To date we have prepared and submitted
multiple regulatory filings in the United States, Europe, and Japan related to
various cell processing systems under development, which notably resulted in
receipt of a CE Mark on the Celution™ 800 System and 510(K), and clearance in
the United States for various related medical technologies, including a cell
saver device.
We must
comply with extensive regulations from foreign jurisdictions regarding safety,
manufacturing processes and quality. These regulations,
including the requirements for marketing authorization, may differ from the
United States FDA regulatory scheme. Specifically, in regard to our
Thin Film product line in Japan (distributed by Senko), we have been seeking
marketing authorization from the Japanese Ministry of Health, Labour and Welfare
for the past three years without success.
10
Staff
As of
December 31, 2007, we had 143 employees, including part-time and full-time
employees. These employees are comprised of 90 employees in research
and development, 11 employees in sales and marketing and 42 employees in
management and finance and administration. From time to time, we also
employ independent contractors to support our operations. Our
employees are not represented by any collective bargaining unit and we have
never experienced an organized work stoppage. A breakout by segment
is as follows:
Regenerative
Cell Technology
|
Corporate
|
Total
|
||||
Research
& Development
|
90
|
—
|
90
|
|||
Sales
and Marketing
|
11
|
—
|
11
|
|||
General
& Administrative
|
—
|
42
|
42
|
|||
Total
|
101
|
42
|
143
|
Web
Site Access to SEC Filings
We
maintain an Internet website at www.cytoritx.com. Through this site, we make
available free of charge our annual reports on Form 10-K, quarterly reports on
Form 10-Q, current reports on Form 8-K, and amendments to those reports filed or
furnished pursuant to Section 13(a) of the Securities Exchange Act of 1934 as
soon as reasonably practicable after we electronically file such material with,
or furnish it to, the U.S. Securities and Exchange Commission (SEC). In
addition, we publish on our website all reports filed under Section 16(a) of the
Securities Exchange Act by our directors, officers and 10% stockholders. These
materials are accessible via the Investor Relations section of our website
within the “SEC Filings” link. Some of the information is stored directly on our
website, while other information can be accessed by selecting the provided link
to the section on the SEC website, which contains filings for our company and
its insiders.
We file
electronically with the SEC our annual reports on Form 10-K, quarterly reports
on Form 10-Q and current reports on Form 8-K pursuant to Section 13(a) of the
Securities Exchange Act of 1934. The SEC maintains an Internet site
that contains reports, proxy information and information statements, and other
information regarding issuers that file electronically with the
SEC. The address of that website is http://www.sec.gov. The
materials are also available at the SEC’s Public Reference Room, located at 100
F Street, Washington, D.C. 20549. The public may obtain information
through the public reference room by calling the SEC at
1-800-SEC-0330.
Item 1A. Risk Factors
In
analyzing our company, you should consider carefully the following risk factors,
together with all of the other information included in this annual report on
Form 10-K. Factors that could adversely affect our business,
operating results and financial condition, as well as adversely affect the value
of an investment in our common stock, include those discussed below,
as well as those discussed below in “Management’s Discussion and Analysis of
Financial Condition and Results of Operations” and elsewhere throughout this
annual report on Form 10-K.
We are
subject to the following significant risks, among others:
We will need to raise more
cash in the future
We have
almost always had negative cash flows from operations. Our business
will continue to result in a substantial requirement for research and
development expenses for several years, during which we may not be able to bring
in sufficient cash and/or revenues to offset these expenses. There is
no guarantee that adequate funds will be available when needed from operating
revenues, additional debt or equity financing, arrangements with distribution
partners, or from other sources, or on terms attractive to us. The
inability to obtain sufficient funds would require us to delay, scale back, or
eliminate some or all of our research or product development, manufacturing
operations, clinical or regulatory activities, or to out-license commercial
rights to products or technologies thus having a substantial negative effect on
our results of operations and financial condition.
11
We have never been
profitable on an operational basis and expect significant operating losses for
the next few years
We have
incurred net operating losses in each year since we started
business. As our focus on the CelutionTM System
platform and development of therapeutic applications for its cellular output has
increased, losses have resulted primarily from expenses associated with research
and development activities and general and administrative
expenses. We expect to continue operating in a loss position on a
consolidated basis and that recurring operating expenses will be at high levels
for the next several years, in order to perform clinical trials, product
development, and additional pre-clinical research.
Our business strategy is
high-risk
We are
focusing our resources and efforts primarily on development of the CelutionTM System
family of products and the therapeutic applications of its cellular output,
which requires extensive cash needs for research and development
activities. This is a high-risk strategy because there is no
assurance that our products will ever become commercially viable (commercial
risk), that we will prevent other companies from depriving us of market share
and profit margins by selling products based on our inventions and developments
(legal risk), that we will successfully manage a company in a new area of
business (regenerative medicine) and on a different scale than we have operated
in the past (operational risk), that we will be able to achieve the desired
therapeutic results using stem and regenerative cells (scientific risk), or that
our cash resources will be adequate to develop our products until we become
profitable, if ever (financial risk). We are using our cash in one of
the riskiest industries in the economy (strategic risk). This may
make our stock an unsuitable investment for many investors.
We must keep our joint
venture with Olympus operating smoothly
Our
business cannot succeed on the currently anticipated timelines unless our joint
venture collaboration with Olympus goes well. We have given
Olympus-Cytori, Inc. an exclusive license to manufacture future generation
CelutionTM System
devices. If Olympus-Cytori, Inc. does not successfully develop and
manufacture these devices, we may not be able to commercialize any device or any
therapeutic products successfully into the market. In addition,
future disruption or breakup of our relationship would be extremely costly to
our reputation, in addition to causing many serious practical
problems.
We and
Olympus must overcome contractual and cultural barriers. Our
relationship is formally measured by a set of complex contracts, which have not
yet been tested in practice. In addition, many aspects of the
relationship will be non-contractual and must be worked out between the parties
and the responsible individuals. The Joint Venture is intended to
have a long life, and it is difficult to maintain cooperative relationships over
a long period of time in the face of various kinds of
change. Cultural differences, including language barrier to some
degree, may affect the efficiency of the relationship.
Olympus-Cytori,
Inc. is 50% owned by us and 50% owned by Olympus. By contract, each
side must consent before any of a wide variety of important business actions can
occur. This situation possesses a risk of potentially time-consuming
and difficult negotiations which could at some point delay the Joint Venture
from pursuing its business strategies.
Olympus
is entitled to designate the Joint Venture's chief executive officer and a
majority of its board of directors, which means that day-to-day decisions which
are not subject to a contractual veto will essentially be controlled by
Olympus. In addition, Olympus-Cytori, Inc. will continue to require
more money than its initial capitalization in order to complete development and
production of future generation devices. If we are unable to help
provide future financing for Olympus-Cytori, Inc., our relative equity interest
in Olympus-Cytori, Inc. may decrease.
Furthermore,
under a License/Joint Development Agreement among Olympus-Cytori, Inc., Olympus,
and us, Olympus will have a primary role in the development of Olympus-Cytori,
Inc.’s next generation devices. Although Olympus has extensive
experience in developing medical devices, this arrangement will result in a
reduction of our control over the development and manufacturing of the next
generation devices.
We have a limited operating
history; operating results and stock price can be volatile like many life
science companies
Our
prospects must be evaluated in light of the risks and difficulties frequently
encountered by emerging companies and particularly by such companies in rapidly
evolving and technologically advanced biotech and medical
device fields. Due to limited operating history and the
transition from the MacroPore biomaterials to the regenerative medicine business
, comparisons of our year-to-year operating results are not necessarily
meaningful and the results for any periods should not necessarily be relied upon
as an indication of future performance. All 2007 product revenues
came from our spine and orthopedics implant product line, which we sold in May
2007.
12
From time
to time, we have tried to update our investors’ expectations as to our operating
results by periodically announcing financial guidance. However, we
have in the past been forced to revise or withdraw such guidance due to lack of
visibility and predictability of product demand.
We are vulnerable to
competition and technological change, and also to physicians’
inertia
We
compete with many domestic and foreign companies in developing our technology
and products, including biotechnology, medical device, and pharmaceutical
companies. Many current and potential competitors have substantially
greater financial, technological, research and development, marketing, and
personnel resources. There is no assurance that our competitors will
not succeed in developing alternative products that are more effective, easier
to use, or more economical than those which we have developed or are in the
process of developing, or that would render our products obsolete and
non-competitive. In general, we may not be able to prevent others
from developing and marketing competitive products similar to ours or which
perform similar functions.
Competitors
may have greater experience in developing therapies or devices, conducting
clinical trials, obtaining regulatory clearances or approvals, manufacturing and
commercialization. It is possible that competitors may obtain patent
protection, approval, or clearance from the FDA or achieve commercialization
earlier than we can, any of which could have a substantial negative effect on
our business. Finally, Olympus and our other partners might pursue
parallel development of other technologies or products, which may result in a
partner developing additional products competitive with ours.
We
compete against cell-based therapies derived from alternate sources, such as
bone marrow, umbilical cord blood and potentially embryos. Doctors
historically are slow to adopt new technologies like ours, whatever the merits,
when older technologies continue to be supported by established
providers. Overcoming such inertia often requires very significant
marketing expenditures or definitive product performance and/or pricing
superiority.
We expect
physicians’ inertia and skepticism to also be a significant barrier as we
attempt to gain market penetration with our future products. We believe we will
need to finance lengthy time-consuming clinical studies (so as to provide
convincing evidence of the medical benefit) in order to overcome this inertia
and skepticism particularly in reconstructive surgery, cell preservation, the
cardiovascular area and many other indications.
Most products are
pre-commercialization, which subjects us to development and marketing
risks
We are in
a relatively early stage of the path to commercialization with many of our
products. We believe that our long-term viability and growth will
depend in large part on our ability to develop commercial quality cell
processing devices and useful procedure-specific consumables, and to establish
the safety and efficacy of our therapies through clinical trials and
studies. With our CelutionTM
platform, we are pursuing new approaches for reconstructive surgery,
preservation of stem and regenerative cells for potential future use, therapies
for cardiovascular disease, gastrointestinal disorders and spine and orthopedic
conditions. There is no assurance that our development programs will
be successfully completed or that required regulatory clearances or approvals
will be obtained on a timely basis, if at all.
There is
no proven path for commercializing the CelutionTM System
platform in a way to earn a durable profit commensurate with the medical
benefit. Although we intend to commercialize into the European
reconstructive surgery and Japanese cell banking markets in 2008, additional
market opportunities for our products and/or services are at least two to five
years away.
Successful
development and market acceptance of our products is subject to developmental
risks, including failure of inventive imagination, ineffectiveness, lack of
safety, unreliability, failure to receive necessary regulatory clearances or
approvals, high commercial cost, preclusion or obsolescence resulting from third
parties’ proprietary rights or superior or equivalent products, competition from
copycat products, and general economic conditions affecting purchasing
patterns. There is no assurance that we or our partners will
successfully develop more effective and commercialize our products, or that our
competitors will not develop competing technologies that are less expensive or
superior. Failure to successfully develop and market our products
would have a substantial negative effect on our results of operations and
financial condition.
The timing and amount of
Thin Film revenues from Senko are uncertain
The sole
remaining product line in our MacroPore Biosurgery segment is our Japan Thin
Film business. Our right to receive royalties from Senko, and to
recognize certain deferred revenues, depends on the timing of MHLW approval for
commercialization of the product in Japan. We currently expect this
to occur in 2008, but we have no control over this timing and our previous
expectations have not been met. Also, even after commercialization,
we will be dependent on Senko, our exclusive distributor, to drive product sales
in Japan.
13
There is
a risk that we could experience with Senko some of the same problems we
experienced in our previous relationship with Medtronic, which was the exclusive
distributor for our former bioresorbable spine and orthopedic implant product
line.
We have limited
manufacturing experience
We have
limited experience in manufacturing the Celution™ System platform or its
consumables at a commercial level. With respect to our Joint Venture,
although Olympus is a highly capable and experienced manufacturer of medical
devices, there can be no guarantee that the Olympus-Cytori Joint Venture will be
able to successfully develop and manufacture the next generation
Celution™ device in a manner that is cost-effective or commercially viable,
or that development and manufacturing capabilities might not take much longer
than currently anticipated to be ready for the market.
Although
we intend to introduce the Celution™ 800 and launch the Celution™ 900-based
StemSource™ Cell Bank in 2008 as we await the availability of the Joint Venture
system, next generation Celution™ device, we cannot assure that we will be able
to manufacture sufficient numbers to meet the demand, or that we will be able to
overcome unforeseen manufacturing difficulties for these sophisticated medical
devices.
In the
event that the Olympus-Cytori Joint Venture is not successful, Cytori may not
have the resources or ability to self-manufacture sufficient numbers of devices
and consumables to meet market demand, and this failure may substantially extend
the time it would take for us to bring a more advanced commercial device to
market. This makes us significantly dependant on the continued dedication and
skill of Olympus for the successful development of the next generation Celution™
device.
We may not be able to
protect our proprietary rights
Our
success depends in part on whether we can obtain additional patents, maintain
trade secret protection, and operate without infringing on the proprietary
rights of third parties.
Our
recently amended regenerative cell technology license agreement with the Regents
of the University of California (“UC”) contains certain developmental
milestones, which if not achieved could result in the loss of exclusivity or
loss of the license rights. The loss of such rights could impact our ability to
develop certain regenerative cell technology products. Also, our
power as licensee to successfully use these rights to exclude competitors from
the market is untested. In addition, further legal risk arises from a
lawsuit filed by the University of Pittsburgh naming all of the inventors who
had not assigned their ownership interest in Patent 6,777,231 to the University
of Pittsburgh, seeking a determination that its assignors, rather than UC’s
assignors, are the true inventors of Patent 6,777,231. We are the exclusive,
worldwide licensee of the UC’s rights under this patent in humans, which relates
to adult stem cells isolated from adipose tissue that can differentiate into two
or more of a variety of cell types. If the University of Pittsburgh wins the
lawsuit, our license rights to this patent could be nullified or rendered
non-exclusive with respect to any third party that might license rights from the
University of Pittsburgh.
On August
9, 2007, the United States District Court granted the University of Pittsburgh’s
motion for Summary Judgment in part, determining that the University of
Pittsburgh’s assignees were properly named as inventors on Patent 6,777,231, and
that all other inventorship issues shall be determined according to the facts
presented at trial which was completed in January 2008. We expect the court to
make its final ruling on all of the other matters in the first or second quarter
of 2008.
There can
be no assurance that any of the pending patent applications will be approved or
that we will develop additional proprietary products that are
patentable. There is also no assurance that any patents issued to us
will provide us with competitive advantages, will not be challenged by any third
parties, or that the patents of others will not prevent the commercialization of
products incorporating our technology. Furthermore, there can be no
guarantee that others will not independently develop similar products, duplicate
any of our products, or design around our patents.
Our
commercial success will also depend, in part, on our ability to avoid infringing
on patents issued to others. If we were judicially determined to be
infringing on any third-party patent, we could be required to pay damages, alter
our products or processes, obtain licenses, or cease certain
activities. If we are required in the future to obtain any licenses
from third parties for some of our products, there can be no guarantee that we
would be able to do so on commercially favorable terms, if at
all. U.S. patent applications are not immediately made public, so we
might be surprised by the grant to someone else of a patent on a technology we
are actively using. As noted above as to the University of Pittsburgh
lawsuit, even patents issued to us or our licensors might be judicially
determined to belong in full or in part to third parties.
14
Litigation,
which would result in substantial costs to us and diversion of effort on our
part, may be necessary to enforce or confirm the ownership of any patents issued
or licensed to us, or to determine the scope and validity of third-party
proprietary rights. If our competitors claim technology also claimed
by us and prepare and file patent applications in the United States of America,
we may have to participate in interference proceedings declared by the U.S.
Patent and Trademark Office or a foreign patent office to determine priority of
invention, which could result in substantial costs to and diversion of effort,
even if the eventual outcome is favorable to us.
Any such
litigation or interference proceeding, regardless of outcome, could be expensive
and time-consuming. We have been incurring substantial legal costs as
a result of the University of Pittsburgh lawsuit, and our president, Marc
Hedrick, is a named individual defendant in that lawsuit because he is one of
the inventors identified on the patent. As a named inventor on the
patent, Marc Hedrick is entitled to receive from the UC up to 7% of royalty
payments made by a licensee (us) to UC. This agreement was in place
prior to his employment with us.
In
addition to patents, which alone may not be able to protect the fundamentals of
our regenerative cell business, we also rely on unpatented trade secrets and
proprietary technological expertise. Our intended future cell-related
therapeutic products, such as consumables, are likely to fall largely into this
category. We rely, in part, on confidentiality agreements with our
partners, employees, advisors, vendors, and consultants to protect our trade
secrets and proprietary technological expertise. There can be no guarantee that
these agreements will not be breached, or that we will have adequate remedies
for any breach, or that our unpatented trade secrets and proprietary
technological expertise will not otherwise become known or be independently
discovered by competitors.
Failure
to obtain or maintain patent protection, or protect trade secrets, for any
reason (or third-party claims against our patents, trade secrets, or proprietary
rights, or our involvement in disputes over our patents, trade secrets, or
proprietary rights, including involvement in litigation), could have a
substantial negative effect on our results of operations and financial
condition.
We may not be able to
protect our intellectual property in countries outside the United
States
Intellectual
property law outside the United States is uncertain and in many countries is
currently undergoing review and revisions. The laws of some countries
do not protect our patent and other intellectual property rights to the same
extent as United States laws. Third parties may attempt to oppose the
issuance of patents to us in foreign countries by initiating opposition
proceedings. Opposition proceedings against any of our patent filings in a
foreign country could have an adverse effect on our corresponding patents that
are issued or pending in the U.S. It may be necessary or useful for us to
participate in proceedings to determine the validity of our patents or our
competitors’ patents that have been issued in countries other than the U.S. This
could result in substantial costs, divert our efforts and attention from other
aspects of our business, and could have a material adverse effect on our results
of operations and financial condition. We currently have pending patent
applications in Europe, Australia, Japan, Canada, China, Korea, and Singapore,
among others.
We and Olympus-Cytori, Inc.
are subject to intensive FDA regulation
As newly
developed medical devices, CelutionTM System
family of products must receive regulatory clearances or approvals from the FDA
and, in many instances, from non-U.S. and state governments prior to their
sale. The CelutionTM System
family of products is subject to stringent government regulation in the United
States by the FDA under the Federal Food, Drug and Cosmetic Act. The
FDA regulates the design/development process, clinical testing, manufacture,
safety, labeling, sale, distribution, and promotion of medical devices and
drugs. Included among these regulations are pre-market clearance and
pre-market approval requirements, design control requirements, and the Quality
System Regulations/Good Manufacturing Practices. Other statutory and
regulatory requirements govern, among other things, establishment registration
and inspection, medical device listing, prohibitions against misbranding and
adulteration, labeling and post-market reporting.
The
regulatory process can be lengthy, expensive, and uncertain. Before
any new medical device may be introduced to the United States of America market,
the manufacturer generally must obtain FDA clearance or approval through either
the 510(k) pre-market notification process or the lengthier pre-market approval
application (“PMA”) process. It generally takes from three to 12
months from submission to obtain 510(k) pre-market clearance, although it may
take longer. Approval of a PMA could take four or more years from the
time the process is initiated. The 510(k) and PMA processes can be
expensive, uncertain, and lengthy, and there is no guarantee of ultimate
clearance or approval. We expect that some of our future products
under development as well as Olympus-Cytori’s will be subject to the lengthier
PMA process. Securing FDA clearances and approvals may require the
submission of extensive clinical data and supporting information to the FDA, and
there can be no guarantee of ultimate clearance or approval. Failure
to comply with applicable requirements can result in application integrity
proceedings, fines, recalls or seizures of products, injunctions, civil
penalties, total or partial suspensions of production, withdrawals of existing
product approvals or clearances, refusals to approve or clear new applications
or notifications, and criminal prosecution.
15
Medical
devices are also subject to post-market reporting requirements for deaths or
serious injuries when the device may have caused or contributed to the death or
serious injury, and for certain device malfunctions that would be likely to
cause or contribute to a death or serious injury if the malfunction were to
recur. If safety or effectiveness problems occur after the product
reaches the market, the FDA may take steps to prevent or limit further marketing
of the product. Additionally, the FDA actively enforces regulations
prohibiting marketing and promotion of devices for indications or uses that have
not been cleared or approved by the FDA.
There can
be no guarantee that we will be able to obtain the necessary 510(k) clearances
or PMA approvals to market and manufacture our other products in the United
States of America for their intended use on a timely basis, if at
all. Delays in receipt of or failure to receive such clearances or
approvals, the loss of previously received clearances or approvals, or failure
to comply with existing or future regulatory requirements could have a
substantial negative effect on our results of operations and financial
condition.
To sell in international
markets, we will be subject to intensive regulation in foreign
countries
In
cooperation with our distribution partners, we intend to market our current and
future products both domestically and in many foreign markets. A number of risks
are inherent in international transactions. In order for us to market
our products in Europe, Canada, Japan and certain other non-U.S. jurisdictions,
we need to obtain and maintain required regulatory approvals or clearances and
must comply with extensive regulations regarding safety, manufacturing processes
and quality. For example, we still have not obtained regulatory
approval for our Thin Film products in Japan. These regulations,
including the requirements for approvals or clearances to market, may differ
from the FDA regulatory scheme. International sales also may be
limited or disrupted by political instability, price controls, trade
restrictions and changes in tariffs. Additionally, fluctuations in
currency exchange rates may adversely affect demand for our products by
increasing the price of our products in the currency of the countries in which
the products are sold.
There can
be no assurance that we will obtain regulatory approvals or clearances in all of
the countries where we intend to market our products, or that we will not incur
significant costs in obtaining or maintaining foreign regulatory approvals or
clearances, or that we will be able to successfully commercialize current or
future products in various foreign markets. Delays in receipt of
approvals or clearances to market our products in foreign countries, failure to
receive such approvals or clearances or the future loss of previously received
approvals or clearances could have a substantial negative effect on our results
of operations and financial condition.
Changing, New and/or
Emerging Government Regulations
Government
regulations can change without notice. Given that fact that Cytori operates in
various international markets, our access to such markets could change with
little to no warning due to a change in government regulations that suddenly
up-regulate our product(s) and create greater regulatory burden for our cell
therapy and cell banking technology products.
Due to
the fact that there are new and emerging cell therapy and cell banking
regulations that have recently been drafted and/or implemented in various
countries around the world, the application and subsequent implementation of
these new and emerging regulations have little to no precedence. Therefore, the
level of complexity and stringency is not known and may vary from country to
country, creating greater uncertainty for the international regulatory
process.
Health Insurance
Reimbursement Risks
New and
emerging cell therapy and cell banking technologies, such as those provided by
the CelutionTM System
family of products, may have difficulty or encounter significant delays in
obtaining health care reimbursement in some or all countries around the world
due to the novelty of our cell therapy and cell banking technology
and subsequent lack of existing reimbursement schemes /
pathways Therefore, the creation of new reimbursement pathways may be
complex and lengthy with no assurances that such reimbursements will be
successful. The lack of health insurance reimbursement or reduced or minimal
reimbursement pricing may have a significant impact on our ability to
successfully sell our cell therapy and cell banking technology product(s) into a
county or region.
16
Market Acceptance of New
Technology
New and
emerging cell therapy and cell banking technologies, such as those provided by
the CelutionTM System
family of products, may have difficulty or encounter significant delays in
obtaining market acceptance in some or all countries around the world due to the
novelty of our cell therapy and cell banking technologies. Therefore, the market
adoption of our cell therapy and cell banking technologies may be slow and
lengthy with no assurances that significant market adoption will be successful.
The lack of market adoption or reduced or minimal market adoption of our cell
therapy and cell banking technologies may have a significant impact on our
ability to successfully sell our product(s) into a county or
region.
We and/or the Joint Venture
have to maintain quality assurance certification and manufacturing
approvals
The
manufacture of our Celution™ System will be, and the manufacture of any future
cell-related therapeutic products would be, subject to periodic inspection by
regulatory authorities and distribution partners. The manufacture of
devices and products for human use is subject to regulation and inspection from
time to time by the FDA for compliance with the FDA’s Quality System Regulation
(“QSR”) requirements, as well as equivalent requirements and inspections by
state and non-U.S. regulatory authorities. There can be no guarantee
that the FDA or other authorities will not, during the course of an inspection
of existing or new facilities, identify what they consider to be deficiencies in
our compliance with QSRs or other requirements and request, or seek, remedial
action.
Failure
to comply with such regulations or a potential delay in attaining compliance may
adversely affect our manufacturing activities and could result in, among other
things, injunctions, civil penalties, FDA refusal to grant pre-market approvals
or clearances of future or pending product submissions, fines, recalls or
seizures of products, total or partial suspensions of production, and criminal
prosecution. There can be no assurance after such occurrences that we
will be able to obtain additional necessary regulatory approvals or clearances
on a timely basis, if at all. Delays in receipt of or failure to
receive such approvals or clearances, or the loss of previously received
approvals or clearances could have a substantial negative effect on our results
of operations and financial condition.
We depend on a few key
officers
Our
performance is substantially dependent on the performance of our executive
officers and other key scientific staff, including Christopher J. Calhoun, our
Chief Executive Officer, and Marc Hedrick, MD, our President. We rely
upon them for strategic business decisions and guidance. We believe that our
future success in developing marketable products and achieving a competitive
position will depend in large part upon whether we can attract and retain
additional qualified management and scientific personnel. Competition
for such personnel is intense, and there can be no assurance that we will be
able to continue to attract and retain such personnel. The loss of
the services of one or more of our executive officers or key scientific staff or
the inability to attract and retain additional personnel and develop expertise
as needed could have a substantial negative effect on our results of operations
and financial condition.
We may not have enough
product liability insurance
The
testing, manufacturing, marketing, and sale of our regenerative cell products
involve an inherent risk that product liability claims will be asserted against
us, our distribution partners, or licensees. There can be no
guarantee that our clinical trial and commercial product liability insurance is
adequate or will continue to be available in sufficient amounts or at an
acceptable cost, if at all. A product liability claim, product
recall, or other claim, as well as any claims for uninsured liabilities or in
excess of insured liabilities, could have a substantial negative effect on our
results of operations and financial condition. Also, well-publicized
claims could cause our stock to fall sharply, even before the merits of the
claims are decided by a court.
Our charter documents
contain anti-takeover provisions and we have adopted a Stockholder Rights Plan
to prevent hostile takeovers
Our
Amended and Restated Certificate of Incorporation and Bylaws contain certain
provisions that could prevent or delay the acquisition of the Company
by means of a tender offer, proxy contest, or otherwise. They could
discourage a third party from attempting to acquire control of Cytori, even if
such events would be beneficial to the interests of our
stockholders. Such provisions may have the effect of delaying,
deferring, or preventing a change of control of Cytori and consequently could
adversely affect the market price of our shares. Also, in 2003 we adopted a
Stockholder Rights Plan of the kind often referred to as a poison pill. The
purpose of the Stockholder Rights Plan is to prevent coercive takeover tactics
that may otherwise be utilized in takeover attempts. The existence of such a
rights plan may also prevent or delay a change in control of Cytori, and this
prevention or delay adversely affect the market price of our
shares.
17
We pay no
dividends
We have
never paid in the past, and currently do not intend to pay any cash dividends in
the foreseeable future.
Item 1B. Unresolved Staff Comments
Not
applicable.
Item 2. Properties
On May
24, 2005, we entered into a lease for 91,000 square feet located at 3020 and
3030 Callan Road, San Diego, California. We moved the majority of our
operations to this new facility during the second half of 2005 and the first
quarter of 2006. The agreement bears rent at a rate of $1.15 per
square foot, with annual increases of 3%. The lease term is 57
months, commencing on October 1, 2005 and expiring on June 30,
2010. We also lease a 4,027 square feet of office space located at
9-3 Otsuka 2-chome, Bunkyo-ku, Tokyo, Japan. The agreement provides
for rent at a rate of $4.38 per square foot, expiring on November 30,
2009. For both properties, we pay an aggregate of approximately
$133,000 in rent per month.
Item 3. Legal Proceedings
From time
to time, we have been involved in routine litigation incidental to the conduct
of our business. As of December 31, 2007, we were not a party to any material
legal proceeding.
Item 4. Submission of Matters to a Vote of Security
Holders
None.
18
PART
II
Item 5. Market for Registrant’s Common Equity, Related
Stockholder Matters and Issuer Purchases of Equity Securities
Market
Prices
From
August 2000 (our initial public offering in Germany) through September 2007 our
common stock was quoted on the Frankfurt Stock Exchange under the symbol “XMPA”
(formerly XMP). In September 2007 our stock closed trading on the Frankfurt
Stock Exchange. Effective December 19, 2005, we began trading on the
Nasdaq Capital Market under the symbol “CYTX,” and have since transferred to the
Nasdaq Global Market effective February 14, 2006. The following table shows the
high and low sales prices for our common stock for the periods indicated, as
reported by the Nasdaq Stock Market. These prices do not include retail markups,
markdowns or commissions.
Nasdaq Stock Exchange
High
|
Low
|
|||||||
2005
|
||||||||
Quarter
ended December 31, 2005
|
$ | 10.01 | $ | 7.60 | ||||
2006
|
||||||||
Quarter
ended March 31, 2006
|
$ | 9.20 | $ | 6.65 | ||||
Quarter
ended June 30, 2006
|
$ | 9.16 | $ | 6.66 | ||||
Quarter
ended September 30, 2006
|
$ | 8.00 | $ | 4.05 | ||||
Quarter
ended December 31, 2006
|
$ | 7.43 | $ | 3.87 | ||||
2007
|
||||||||
Quarter
ended March 31, 2007
|
$ | 7.00 | $ | 4.56 | ||||
Quarter
ended June 30, 2007
|
$ | 6.69 | $ | 5.36 | ||||
Quarter
ended September 30, 2007
|
$ | 6.67 | $ | 4.85 | ||||
Quarter
ended December 31, 2007
|
$ | 6.50 | $ | 4.88 |
All of
our outstanding shares have been deposited with DTCC since December 9,
2005.
We had
approximately 13 stockholders of record as of February 29, 2008. We are aware
that the number of beneficial owners is substantially greater than the number of
record holders because a large portion of our common stock is held of record
through brokerage firms in “street name.”
Dividends
We have
never declared or paid any dividends and do not anticipate paying any in the
foreseeable future.
Equity
Compensation Plan Information
Plan Category
|
Number of securities to be issued
upon exercise of outstanding
options, warrants and rights
|
Weighted-average exercise price
of outstanding options, warrants
and rights
|
Number
of securities remaining
available
for future issuance under equity compensation
plans (excluding securities reflected
in column(a))
|
|||||||||
(a)
|
(b)
|
(c)
|
||||||||||
Equity
compensation plans approved by security holders (1)
|
4,252,357 | $ | 4.47 | — | ||||||||
Equity
compensation plans not approved by security holders (2)
|
1,754,918 | $ | 5.78 | 2,129,146 | ||||||||
Total
|
6,007,275 | $ | 4.85 | 2,129.146 |
________________________________________
(1)
|
The
1997 Stock Option and Stock Purchase Plan expired on October 22,
2007.
|
(2)
|
The
maximum number of shares shall be cumulatively increased on the first
January 1 after the Effective Date, August 24, 2004, and each January 1
thereafter for 9 more years, by a number of shares equal to the lesser of
(a) 2% of the number of shares issued and outstanding on the immediately
preceding December 31, and (b) a number of shares set by the
Board.
|
19
Comparative
Stock Performance Graph
The
following graph shows how an initial investment of $100 in our common stock
would have compared to an equal investment in the Nasdaq Composite Index and the
Amex Biotechnology Index during the period from January 1, 2002, through
December 31, 2007. The performance shown is not necessarily indicative of future
price performance.
Item 6. Selected Financial Data
The
selected data presented below under the captions “Statements of Operations
Data,” “Statements of Cash Flows Data” and “Balance Sheet Data” for, and as of
the end of, each of the years in the five-year period ended December 31, 2007,
are derived from, and should be read in conjunction with, our audited
consolidated financial statements. The consolidated balance sheets as of
December 31, 2007 and 2006, and the related consolidated statements of
operations and comprehensive loss, stockholders’ equity (deficit), and cash
flows for each of the years in the three-year period ended December 31, 2007,
which have been audited by KPMG LLP, an independent registered public accounting
firm, and their report thereon, are included elsewhere in this annual report.
The consolidated balance sheets as of December 31, 2005, 2004 and 2003, and the
related consolidated statements of operations and comprehensive loss,
stockholders’ equity (deficit), and cash flows for the years ended December 31,
2004 and 2003, which were also audited by KPMG LLP, are included with our annual
reports previously filed.
20
The
information contained in this table should also be read in conjunction with
“Management’s Discussion and Analysis of Financial Condition and Results of
Operations” and the financial statements and related notes thereto included
elsewhere in this report (in thousands except share and per share
data):
2007
|
2006
|
2005
|
2004
|
2003
|
||||||||||||||||
Statements
of Operations Data:
|
||||||||||||||||||||
Product
revenues:
|
||||||||||||||||||||
Sales
to related party
|
$ | 792 | $ | 1,451 | $ | 5,634 | $ | 4,085 | $ | 12,893 | ||||||||||
Sales
to third parties
|
— | — | — | 2,237 | 1,186 | |||||||||||||||
792 | 1,451 | 5,634 | 6,322 | 14,079 | ||||||||||||||||
Cost
of product revenues
|
422 | 1,634 | 3,154 | 3,384 | 4,244 | |||||||||||||||
Gross
profit (loss)
|
370 | (183 | ) | 2,480 | 2,938 | 9,835 | ||||||||||||||
Development
revenues:
|
||||||||||||||||||||
Development
|
5,168 | 6,057 | 51 | 158 | 9 | |||||||||||||||
Research
grants and other
|
89 | 419 | 320 | 338 | — | |||||||||||||||
5,257 | 6,476 | 371 | 496 | 9 | ||||||||||||||||
Operating
expenses:
|
||||||||||||||||||||
Research
and development
|
20,020 | 21,977 | 15,450 | 10,384 | 8,772 | |||||||||||||||
Sales
and marketing
|
2,673 | 2,055 | 1,547 | 2,413 | 4,487 | |||||||||||||||
General
and administrative
|
14,184 | 12,547 | 10,208 | 6,551 | 5,795 | |||||||||||||||
Change
in fair value of option liabilities
|
100 | (4,431 | ) | 3,645 | — | — | ||||||||||||||
Restructuring
charge
|
— | — | — | 107 | 451 | |||||||||||||||
Equipment
impairment charge
|
— | — | — | 42 | — | |||||||||||||||
Total
operating expenses
|
36,977 | 32,148 | 30,850 | 19,497 | 19,505 | |||||||||||||||
Other
income (expense):
|
||||||||||||||||||||
Gain
on sale of assets
|
1,858 | — | 5,526 | — | — | |||||||||||||||
Gain
on the sale of assets, related party
|
— | — | — | 13,883 | — | |||||||||||||||
Interest
income
|
1,028 | 708 | 299 | 252 | 417 | |||||||||||||||
Interest
expense
|
(155 | ) | (199 | ) | (137 | ) | (177 | ) | (126 | ) | ||||||||||
Other
income (expense)
|
(46 | ) | (27 | ) | (55 | ) | 15 | 87 | ||||||||||||
Equity
loss in investments
|
(7 | ) | (74 | ) | (4,172 | ) | — | — | ||||||||||||
Net
loss
|
$ | (28,672 | ) | $ | (25,447 | ) | $ | (26,538 | ) | $ | (2,090 | ) | $ | (9,283 | ) | |||||
Basic
and diluted net loss per share
|
$ | (1.25 | ) | $ | (1.53 | ) | $ | (1.80 | ) | $ | (0.15 | ) | $ | (0.64 | ) | |||||
Basic
and diluted weighted average common shares
|
22,889,250 | 16,603,550 | 14,704,281 | 13,932,390 | 14,555,047 | |||||||||||||||
Statements
of Cash Flows Data:
|
||||||||||||||||||||
Net
cash used in operating activities
|
$ | (29,995 | ) | $ | (16,483 | ) | $ | (1,101 | ) | $ | (12,574 | ) | $ | (7,245 | ) | |||||
Net
cash provided by investing activities
|
5,982 | 591 | 911 | 13,425 | 5,954 | |||||||||||||||
Net
cash provided by (used in) financing activities
|
26,576 | 16,787 | 5,357 | (831 | ) | (997 | ) | |||||||||||||
Net
increase (decrease) in cash
|
2,563 | 895 | 5,167 | 20 | (2,288 | ) | ||||||||||||||
Cash
and cash equivalents at beginning of year
|
8,902 | 8,007 | 2,840 | 2,820 | 5,108 | |||||||||||||||
Cash
and cash equivalents at end of year
|
$ | 11,465 | $ | 8,902 | $ | 8,007 | $ | 2,840 | $ | 2,820 | ||||||||||
Balance
Sheet Data:
|
||||||||||||||||||||
Cash,
cash equivalents and short-term investments
|
$ | 11,465 | $ | 12,878 | $ | 15,845 | $ | 13,419 | $ | 14,268 | ||||||||||
Working
capital
|
4,168 | 7,392 | 10,459 | 12,458 | 12,432 | |||||||||||||||
Total
assets
|
21,507 | 24,868 | 28,166 | 25,470 | 28,089 | |||||||||||||||
Deferred
revenues
|
2,379 | 2,389 | 2,541 | 2,592 | — | |||||||||||||||
Deferred
revenues, related party
|
18,748 | 23,906 | 17,311 | — | — | |||||||||||||||
Option
liabilities
|
1,000 | 900 | 5,331 | — | — | |||||||||||||||
Deferred
gain on sale of assets
|
— | — | — | 5,650 | — | |||||||||||||||
Deferred
gain on sale of assets, related party
|
— | — | — | — | 7,539 | |||||||||||||||
Long-term
deferred rent
|
473 | 741 | 573 | 80 | — | |||||||||||||||
Long-term
obligations, less current portion
|
237 | 1,159 | 1,558 | 1,128 | 1,157 | |||||||||||||||
Total
stockholders’ equity (deficit)
|
$ | (9,400 | ) | $ | (10,813 | ) | $ | (6,229 | ) | $ | 12,833 | $ | 14,909 |
21
Item 7. Management’s Discussion and Analysis of
Financial Condition and Results of Operations
CAUTIONARY
STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This
report contains certain statements that may be deemed “forward-looking
statements” within the meaning of United States securities laws. All
statements, other than statements of historical fact, that address activities,
events or developments that we intend, expect, project, believe or anticipate
will or may occur in the future are forward-looking statements. Such
statements are based upon certain assumptions and assessments made by our
management in light of their experience and their perception of historical
trends, current conditions, expected future developments and other factors they
believe to be appropriate. The forward-looking statements included in
this report are also subject to a number of material risks and uncertainties,
including but not limited to the risks described under the “Risk Factors”
section in Part I above.
We
encourage you to read those descriptions carefully. We caution you
not to place undue reliance on the forward-looking statements contained in this
report. These statements, like all statements in this report, speak
only as of the date of this report (unless an earlier date is indicated) and we
undertake no obligation to update or revise the statements except as required by
law. Such forward-looking statements are not guarantees of future
performance and actual results will likely differ, perhaps materially, from
those suggested by such forward-looking statements.
Overview
At
Cytori, our goal is to become a global provider of medical technologies, helping
doctors practice regenerative medicine. Regenerative medicine describes the
emerging field that aims to repair or restore lost or damaged organ and cell
function. Our commercial activities are currently focused on reconstructive
surgery in Europe and stem and regenerative cell banking (cell preservation) in
Japan. Our product pipeline is focused on new treatments for cardiovascular
disease, orthopedic damage, gastrointestinal disorders, and pelvic health
conditions.
The
foundation of our business is the Celution™ System product platform. The
platform products process the patients’ cells at the bedside in real time so
these cells may be re-transplanted into the same patient in the same surgical
procedure. The Celution™ System family of products consists of a central device
and related single-use consumables that are used in every procedure. We are
developing as many applications as possible for the cells, which are processed
by the Celution™ System family of products, in order to increase and maximize
sales of the central device and related consumables to hospitals, clinics, and
physicians.
The
Celution™ 800 and 900 are bedside systems that separate stem and regenerative
cells residing naturally within adipose (fat tissue). We are introducing the
Celution™ 800/CRS in Europe into the reconstructive surgery market and the
Celution™ 900/MB in Japan as part of our comprehensive stem cell banking
(cryopreservation) product offering. We believe these two markets offer the
potential for revenue growth over the next few years until new products come out
of our development pipeline. This product development pipeline includes
applications for cardiovascular disease, for which two clinical trials are
presently underway in Europe, spinal disc repair, gastrointestinal disorders,
and pelvic health conditions.
In 2008,
we will focus on the following initiatives:
·
|
Launching
the StemSource™ Cell Bank to hospitals in Japan through our
commercialization partner, Green Hospital Supply,
Inc.
|
·
|
Introducing
the Celution™ 800/CRS in Europe and Asia-Pacific into the reconstructive
surgery market to select physicians and hospitals through our specialized
medical distribution network.
|
·
|
Initiating
two post-marketing studies in Europe with the Celution™ 800/CRS for the
reconstruction of breast tissue following partial mastectomy to support
expanded marketing efforts and
reimbursement.
|
·
|
Advancing
our cardiovascular disease product pipeline through clinical
development.
|
·
|
Continue
pursuing development and commercialization partnerships for certain
therapeutic applications outside our primary focus of reconstructive
surgery and cardiovascular disease.
|
During
2007, we laid the foundation for our 2008 commercial introduction of the
Celution™ 800/CRS into the European reconstructive surgery market. A broader
launch is expected following the successful completion of two planned breast
reconstruction post-partial mastectomy post-marketing studies designed to
provide Cytori with additional clinical data to support broad physician adoption
and reimbursement. Breast reconstruction is a niche market that we are pursuing
because there is a significant medical need for viable reconstructive
alternatives to partial mastectomy patients. This segment of the reconstructive
surgery market may also be effectively addressed with targeted sales and
distribution efforts. There are an estimated 370,000 patients in Europe
diagnosed each year with breast cancer, of which approximately 75% are eligible
to undergo partial mastectomy. Based on this figure and the survival rate for
breast cancer patients, there are already millions of women in Europe who have
been treated for breast cancer, for which a percentage could be eligible for
partial mastectomy defect reconstruction.
22
Reconstruction of partial mastectomy defects using
adipose-derived stem and regenerative cells, processed with the Celution™ 600
System (a predecessor to the Celution™ 800 System), was reported in December
2007 to be safe and effective in a 21 patient, investigator-initiated study in
Japan. While more clinical trials will be required, the study
observed that combining adipose-derived stem and regenerative cells with
additional adipose tissue in order to fill the defect area was safe and resulted
in 79% patient satisfaction, with a statistically significant improvement and
maintenance of tissue thickness six months following surgery. These results
formed the basis for the design of our two company-sponsored post-marketing
studies in Europe.
In the third quarter of
2007, we entered into a partnership to commercialize the Celution™ 900-based
StemSource™ Cell Bank to hospitals throughout Japan. This partnership is
important as it allows us to capitalize near-term in a scalable fashion on
another application for the Celution™ System platform, the cryopreservation of
cells, which is estimated to be a large, untapped medical market in Japan. The
first cell banks are expected to be installed by the first half of 2008. In the
United States, we are planning to expand the commercial efforts for the
StemSource™ Cell Bank business starting in the middle of 2008 through limited
marketing activities. Unlike in Japan, we will process and store any orders from
patients at our licensed cryopreservation facility in San Diego. Once
established we may continue to commercialize on our own or license the U.S.
StemSourceTM business to a strategic
partner.
The most advanced
therapeutic application in our product development pipeline is cardiovascular
disease. We
currently have two clinical trials underway for adipose-derived stem and
regenerative cells for the treatment of cardiovascular disease, one targeting a
chronic form of heart disease and the other targeting heart attacks, an acute
form of heart disease.
We
identified this market as a priority because we believe there is significant
need for new forms of cardiovascular disease treatment and because it represents
one of the largest global healthcare market opportunities. The American Heart
Association estimates that in the United States of America alone, there are
approximately 865,000 heart attacks each year and more than 13,000,000 people
suffer from coronary heart disease.
Olympus Partnership
On
November 4, 2005, we entered into a strategic development and manufacturing
joint venture agreement and other related agreements (“JV Agreements”) with
Olympus Corporation (“Olympus”). As part of the terms of the JV
Agreements, we formed a joint venture, Olympus-Cytori, Inc. (the “Joint
Venture”), to develop and manufacture future generation devices based on our
Celution™ System platform.
Under the
Joint Venture Agreements:
·
|
Olympus paid $30,000,000 for its 50% interest in the Joint
Venture. Moreover, Olympus simultaneously entered into a
License/Joint Development Agreement with the Joint Venture and us to
develop a second generation commercial system and manufacturing
capabilities.
|
·
|
We licensed our device technology, including the Celution™
System platform and certain related intellectual property, to the Joint
Venture for use in future generation devices. These devices
will process and purify adult stem and regenerative cells residing in
adipose (fat) tissue for various therapeutic clinical
applications. In exchange for this license, we received a 50%
interest in the Joint Venture, as well as an initial $11,000,000 payment
from the Joint Venture; the source of this payment was the $30,000,000
contributed to the Joint Venture by Olympus. Moreover, upon
receipt of a CE mark for the first generation Celution™ System platform in
January 2006, we received an additional $11,000,000 development milestone
payment from the Joint Venture.
|
Put/Calls
and Guarantees
The
Shareholders’ Agreement between Cytori and Olympus provides that in certain
specified circumstances of insolvency or if we experience a change in control,
Olympus will have the rights to (i) repurchase our interests in the Joint
Venture at the fair value of such interests or (ii) sell its own interests in
the Joint Venture to Cytori at the higher of (a) $22,000,000 or (b) the Put’s
fair value.
23
As of
November 4, 2005, the fair value of the Put was determined to be
$1,500,000. At December 31, 2007 and 2006, the fair value of the Put
was $1,000,000 and $900,000, respectively. Fluctuations in the Put
value are recorded in the statements of operations as a component of Change in
fair value of option liabilities. The fair value of the Put has been recorded as
a long-term liability on the balance sheet in the caption option
liability.
The
following assumptions were employed in estimating the value of the
Put:
December
31, 2007
|
December
31, 2006
|
November
4, 2005
|
||||||||||
Expected
volatility of Cytori
|
60.00 | % | 66.00 | % | 63.20 | % | ||||||
Expected
volatility of the Joint Venture
|
60.00 | % | 56.60 | % | 69.10 | % | ||||||
Bankruptcy
recovery rate for Cytori
|
21.00 | % | 21.00 | % | 21.00 | % | ||||||
Bankruptcy
threshold for Cytori
|
$ | 9,324,000 | $ | 10,110,000 | $ | 10,780,000 | ||||||
Probability
of a change of control event for Cytori
|
2.17 | % | 1.94 | % | 3.04 | % | ||||||
Expected
correlation between fair values of Cytori and the Joint Venture in the
future
|
99.00 | % | 99.00 | % | 99.00 | % | ||||||
Risk
free interest rate
|
4.04 | % | 4.71 | % | 4.66 | % |
The Put
has no expiration date. Accordingly, we will continue to recognize a
liability for the Put and mark it to market each quarter until it is exercised
or until the arrangements with Olympus are amended.
The Joint
Venture currently has exclusive access to our technology for the development,
manufacture, and supply of the devices (second generation and beyond) for all
therapeutic applications. Once a later generation Celution™ System is
developed and approved by regulatory agencies, the Joint Venture would sell such
systems exclusively to us at a formula-based transfer price; we have retained
marketing rights to the second generation devices for all therapeutic
applications of adipose stem and regenerative cells.
We have
worked closely with Olympus’ team of scientists and engineers to design the
future generations Celution™ System so that it will contain certain product
enhancements and that can be manufactured in a streamlined
manner.
In August
2007, we entered into a License and Royalty Agreement (“Royalty Agreement”) with
the Joint Venture which provides us the ability to commercially launch the
Celution™ System platform earlier than we could have otherwise done so under the
terms of the Joint Venture Agreements. The Royalty Agreement allows
for the sale of the Cytori-developed Celution™ System platform until
such time as the Joint Venture’s products are commercially available
for the same market served by Cytori platform, subject to a reasonable royalty
that will be payable to the Joint Venture for all such sales.
We
account for our investment in the Joint Venture under the equity method of
accounting.
Other
Related Party Transactions
As part
of the formation of the Joint Venture and as discussed above, the Joint Venture
agreed to purchase development services from Olympus. In December 2005, the
Joint Venture paid to Olympus $8,000,000 as a payment for those services. The
payment has been recognized in its entirety as an expense on the books and
records of the Joint Venture as the expenditure represents a payment for
research and development services that have no alternative future uses. Our
share of this expense has been reflected within the account, equity loss from
investment in joint venture, within the consolidated statement of
operations.
In a
separate agreement entered into on February 23, 2006, we granted Olympus an
exclusive right to negotiate a commercialization collaboration for the use of
adipose stem and regenerative cells for a specific therapeutic area outside of
cardiovascular disease. In exchange for this right, we received a
$1,500,000 payment from Olympus. As part of this agreement, Olympus
will conduct market research and pilot clinical studies in collaboration with us
for the therapeutic area up to December 31, 2008 when this exclusive right will
terminate.
In the
third quarter of 2006, we received net proceeds of $16,219,000 from the sale of
common stock pursuant to a shelf registration statement, of which $11,000,000 of
common stock was purchased by Olympus.
24
MacroPore
Biosurgery
Spine and orthopedic
products
By
selling our spine and orthopedic surgical implant business to Kensey Nash
Corporation (“Kensey Nash”) in the second quarter of 2007, we have completed our
transition away from the bioresorbable product line for which we were originally
founded.
Thin Film Japan Distribution
Agreement
In 2004,
we sold the majority of our Thin Film business to MAST. We retained
all rights to Thin Film business in Japan (subject to a purchase option of MAST,
which expired in May 2007), and we received back from MAST a license of all
rights to Thin Film technologies in the spinal field, exclusive at least until
2012, and the field of regenerative medicine, non-exclusive on a perpetual
basis.
In the
third quarter of 2004, we entered into a Distribution Agreement with
Senko. Under this agreement, we granted to Senko an exclusive license
to sell and distribute certain Thin Film products in
Japan. Specifically, the license covers Thin Film products with the
following indications: anti-adhesion; soft tissue support; and minimization of
the attachment of soft tissues. The Distribution Agreement with Senko
commences upon “commercialization.” Commercialization will occur when
one or more Thin Film product registrations are completed with the Japanese
Ministry of Health, Labour and Welfare (“MHLW”). Following
commercialization, the Distribution Agreement has a duration of five years and
is renewable for an additional five years after reaching mutually agreed minimum
purchase guarantees.
We
received a $1,500,000 upfront license fee from Senko. We have
recorded the $1,500,000 received as a component of deferred revenues in the
accompanying balance sheet. Half of the license fee is refundable if
the parties agree commercialization is not achievable and a proportional amount
is refundable if we terminate the arrangement, other than for material breach by
Senko, before three years post-commercialization.
Under the
Distribution Agreement, we will also be entitled to earn additional payments
from Senko based on achieving defined milestones. On September 28,
2004, we notified Senko of completion of the initial regulatory application to
the MHLW for the Thin Film product. As a result, we became entitled
to a nonrefundable payment of $1,250,000, which we received in October 2004 and
recorded as a component of deferred revenues. To date we have
recognized a total of $371,000 in development revenues ($10,000, $152,000,
$51,000, and $158,000 for the years ended December 31, 2007, 2006, 2005, and
2004, respectively) related to this agreement.
Capital
Requirements and Liquidity
Research
and development for the Celution™ System product platform and clinical
applications of adipose-derived stem and regenerative cell therapies has been
and will continue to be very costly. We anticipate expanding research
and development expenses to fund clinical trials (which were initiated in 2007),
pre-clinical research, and general and administrative activities. As
a result, we expect to continue incurring losses in the near
future.
Over 99%
of our 2007 research and development expenses of $20,020,000 were related to our
regenerative cell technology business, and the majority of those were related to
optimizing the CelutionTM 800/CRS
for reconstructive surgery research and development of cardiovascular disease
applications. We believe research and development expenses will
continue to increase should we advance more products into and through clinical
trials and as we continue our commercial introductions. We plan to
fund this anticipated research and development from: existing cash and
short-term investments; payments, if any, related to potential Celution™ System
platform commercialization partnerships; payments, if any, related to potential
biomaterial divestitures; potential research grants; and sale of common stock
through potential future financings.
As of
December 31, 2007, we had cash and cash equivalents and short-term investments
on hand of $11,465,000 and an accumulated deficit of $132,132,000. On
February 8, 2008, we entered into an agreement to sell 2,000,000 shares of
common stock at $6.00 per share to Green Hospital Supply, Inc. in a private
placement. On February 29, 2008 we closed the first half of the
private placement with Green Hospital Supply, Inc. and received $6,000,000. We
have agreed to close the second half of the private placement on or before April
30, 2008.
25
Results
of Operations
Product
revenues
Product
revenues relate entirely to our MacroPore Biosurgery segment. The
following table summarizes the components for the years ended December 31, 2007,
2006 and 2005:
Years
ended
|
$
Differences
|
%
Differences
|
||||||||||||||||||||||||||
2007
|
2006
|
2005
|
2007
to 2006
|
2006
to 2005
|
2007
to 2006
|
2006
to 2005
|
||||||||||||||||||||||
Product
Revenues:
|
||||||||||||||||||||||||||||
Spine
and orthopedics products
|
$ | 792,000 | $ | 1,451,000 | $ | 5,634,000 | $ | (659,000 | ) | $ | (4,183,000 | ) | (45.4 | )% | (74.2 | )% | ||||||||||||
%
attributable to Medtronic
|
100 | % | 100 | % | 100 | % |
MacroPore
Biosurgery:
·
|
Spine
and orthopedic product revenues represent sales of bioresorbable implants
used in spine and orthopedic surgical procedures. These
products were sold exclusively to
Medtronic.
|
·
|
We
completely divested this product line to Kensey Nash in May
2007.
|
The future: We
have already begun and expect to continue to generate regenerative cell
technology product revenues during 2008 from Celution™ 800/CRS and consumable
sales in Europe and we expect to generate product revenues from StemSourceTM Cell
Bank sales in Japan through our distribution partner Green Hospital Supply, Inc.
We expect to have product revenues related to our MacroPore Biosurgery segment
again when commercialization of the Thin Film products in Japan occurs and we
begin Thin Film shipments to Senko.
Cost of product
revenues
Cost of
product revenues in our MacroPore Biosurgery segment includes material,
manufacturing labor, overhead costs and an inventory provision, if
applicable. The following table summarizes the components of our cost
of revenues for the years ended December 31, 2007, 2006 and 2005:
Years
ended
|
$
and % Differences
|
%
Differences
|
||||||||||||||||||||||||||
2007
|
2006
|
2005
|
2007
to 2006
|
2006
to 2005
|
2007
to 2006
|
2006
to 2005
|
||||||||||||||||||||||
Cost
of product revenues:
|
||||||||||||||||||||||||||||
Cost
of product revenues
|
$ | 403,000 | $ | 1,472,000 | $ | 2,874,000 | $ | (1,069,000 | ) | $ | (1,402,000 | ) | (72.6 | )% | (48.8 | )% | ||||||||||||
%
of product revenues
|
50.9 | % | 101.4 | % | 51.0 | % | (50.5 | )% | 50.4 | % | (49.8 | )% | 98.8 | % | ||||||||||||||
Inventory
provision
|
— | 88,000 | 280,000 | (88,000 | ) | (192,000 | ) | — | (68.6 | )% | ||||||||||||||||||
%
of product revenues
|
— | 6.1 | % | 5.0 | % | (6.1 | )% | 1.1 | % | — | 22.0 | % | ||||||||||||||||
Stock-based
compensation
|
19,000 | 74,000 | — | (55,000 | ) | 74,000 | (74.3 | )% | — | |||||||||||||||||||
%
of product revenues
|
2.4 | % | 5.1 | % | — | (2.7 | )% | 5.1 | % | (52.9 | )% | — | ||||||||||||||||
Total
cost of product revenues
|
$ | 422,000 | $ | 1,634,000 | $ | 3,154,000 | $ | (1,212,000 | ) | $ | (1,520,000 | ) | (74.2 | )% | (48.2 | )% | ||||||||||||
Total
cost of product revenues as % of Product revenues
|
53.3 | % | 112.6 | % | 56.0 | % |
MacroPore
Biosurgery:
·
|
The
decrease in cost of product revenues for the year ended December 31, 2007
as compared to the same period in 2006 was due to a decrease in production
of MacroPore Biosurgery spine and orthopedic products, followed by our
sale of the product line in May
2007.
|
·
|
The
change in cost of revenues for the year ended December 31, 2006 as
compared to the same period in 2005 were due primarily to amounts of fixed
labor and overhead costs applied to product revenues in each
period. As MacroPore revenues declined, gross margins were
negatively affected by fixed costs.
|
·
|
Cost
of product revenues includes approximately $19,000, $74,000 and $0 of
stock-based compensation expense for the years ended December 31, 2007,
2006 and 2005, respectively. For further details, see
stock-based compensation discussion
below.
|
26
·
|
During
the years ended December 31, 2007, 2006, and 2005, we recorded a provision
of $0, $88,000 and $280,000, respectively, related to excess and
slow-moving inventory. In 2006 and 2005, this inventory was produced in
anticipation of stocking orders from Medtronic which did not
materialize.
|
The future. We
expect to incur costs related to our products once commercialization is achieved
for our Japan Thin Film product line, and now that manufacturing of our
Celution™ System platform has begun.
Development
revenues
The
following table summarizes the components of our development revenues for the
years ended December 31, 2007, 2006, and 2005:
Years
ended
|
$
Differences
|
%
Differences
|
||||||||||||||||||||||||||
2007
|
2006
|
2005
|
2007
to 2006
|
2006
to 2005
|
2007
to 2006
|
2006
to 2005
|
||||||||||||||||||||||
Regenerative cell
technology:
|
||||||||||||||||||||||||||||
Milestone
revenue (Olympus)
|
$ | 5,158,000 | $ | 5,905,000 | $ | — | $ | (747,000 | ) | $ | 5,905,000 | (12.7 | )% | — | ||||||||||||||
Research
grant (NIH)
|
— | 310,000 | 312,000 | (310,000 | ) | (2,000 | ) | — | (0.6 | )% | ||||||||||||||||||
Regenerative
cell storage services
|
4,000 | 7,000 | 8,000 | (3,000 | ) | (1,000 | ) | (42.9 | )% | (12.5 | )% | |||||||||||||||||
Other
|
85,000 | 102,000 | — | (17,000 | ) | 102,000 | (16.7 | )% | — | |||||||||||||||||||
Total
regenerative cell technology
|
5,247,000 | 6,324,000 | 320,000 | (1,077,000 | ) | 6,004,000 | (17.0 | )% | 1,876.3 | % | ||||||||||||||||||
MacroPore
Biosurgery:
|
||||||||||||||||||||||||||||
Development
(Senko)
|
10,000 | 152,000 | 51,000 | (142,000 | ) | 101,000 | (93.4 | )% | 198.0 | % | ||||||||||||||||||
Total
development revenues
|
$ | 5,257,000 | $ | 6,476,000 | $ | 371,000 | $ | (1,219,000 | ) | $ | 6,105,000 | (18.8 | )% | 1,645.6 | % |
Regenerative
cell technology:
·
|
We
recognize deferred revenues, related party, as development revenue when
certain performance obligations are met (i.e., using a proportional
performance approach). During the year ended December 31, 2007,
we recognized $5,158,000 of revenue associated with our arrangements with
Olympus. The revenue recognized in 2007 was a result of
completing a pre-clinical study milestone in the second quarter and
completing a development milestone in the third quarter. During
the year ended December 31, 2006, we recognized $5,905,000 of revenue
associated with our arrangements with Olympus. The revenue
recognized in 2006 was a result of completing a pre-clinical study
milestone in the first quarter, receiving a CE mark for the Celution™ 600
System, and reaching three additional milestones in the fourth
quarter. One milestone related to the completion of a
pre-clinical study while the other two were results of product development
efforts. There was no similar revenue in
2005.
|
·
|
The
research grant revenue related to our agreement with the National
Institutes of Health (“NIH”). Under this arrangement, the NIH
reimbursed us for “qualifying expenditures” related to research on
Adipose-Derived Cell Therapy for Myocardial Infarction. To
receive funds under the grant arrangement, we were required to (i)
demonstrate that we incurred “qualifying expenses,” as defined in the
grant agreement between the NIH and us, (ii) maintain a system of
controls, whereby we can accurately track and report all expenditures
related solely to research on Adipose-Derived Cell Therapy for Myocardial
Infarction, and (iii) file appropriate forms and follow appropriate
protocols established by the NIH.
|
During
the year ended December 31, 2006, we incurred $479,000 in expenditures, of which
$310,000 were qualified. We recorded a total of $310,000 in revenues
for the year ended December 31, 2006, which included allowable grant fees as
well as cost reimbursements. During the year ended December 31, 2005,
we incurred $306,000 in qualifying expenditures. We recorded a total
of $312,000 in revenues for the years ended December 31, 2005, which include
allowable grant fees as well as cost reimbursements. Our work under this NIH
agreement was completed in 2006; as a result, there were no comparable revenues
or costs in 2007.
27
MacroPore
Biosurgery (Thin Film):
Under a
Distribution Agreement with Senko we are entitled to earn payments based on
achieving the following defined milestones:
·
|
Upon
notifying Senko of completion of the initial regulatory application to the
MHLW for the Thin Film product, we were entitled to a nonrefundable
payment of $1,250,000. We so notified Senko on
September 28, 2004, received payment in October of 2004, and recorded
deferred revenues of $1,250,000. As of December 31, 2006, of
the amount deferred, we have recognized development revenues of $371,000
($10,000 in 2007, $152,000 in 2006, $51,000 in 2005, and $158,000 prior to
2005).
|
·
|
In
addition, we also received a $1,500,000 license fee that was recorded as a
component of deferred revenues in the accompanying balance
sheet. Because the $1,500,000 in license fees is potentially
refundable, such amounts will not be recognized as revenues until the
refund rights expire. Specifically, half of the license fee is
refundable if the parties agree commercialization is not achievable and a
proportional amount is refundable if we terminate the arrangement, other
than for material breach by Senko, before three years
post-commercialization.
|
·
|
We
are also entitled to a non-refundable payment of $250,000 once we achieve
commercialization.
|
The future: We
expect to recognize revenues from our regenerative cell technology segment
during 2008 as we complete additional research and development
activities. If we are successful in achieving certain milestone
points related to these activities, we will recognize approximately $1,500,000
in revenues in 2008. The exact timing of when amounts will be
reported in revenue will depend on internal and external considerations,
including obtaining the necessary regulatory approvals for various therapeutic
applications related to the Celution™ System platform. The cash for
these performance obligations was received when the agreement was signed and no
further related cash payments will be made to us.
Additionally,
we expect to recognize approximately $250,000 in revenues during 2008 from the
newly awarded NIH grant. We were awarded $250,000 late 2007 to study
adipose-derived stem and regenerative cells for vascular disease.
We will
continue to recognize revenue from the development work we are performing on
behalf of Senko, based on the relative fair value of the milestones completed as
compared to the total efforts expected to be necessary to obtain regulatory
clearance with the MHLW. Obtaining regulatory clearance with the MHLW
for initial commercialization is expected in 2008. Accordingly, we
expect to recognize approximately $1,129,000 (consisting of $879,000 in deferred
revenues plus a non-refundable payment of $250,000 to be received upon
commercialization) in revenues associated with this milestone arrangement in
2008. Moreover, we expect to recognize $500,000 per year associated
with deferred Senko license fees over a three-year period following
commercialization as the refund rights associated with the license payment
expire.
Research and development
expenses
Research
and development expenses include costs associated with the design, development,
testing and enhancement of our products, regulatory fees, the purchase of
laboratory supplies, pre-clinical studies, and clinical studies. The
following table summarizes the components of our research and development
expenses for the years ended December 31, 2007, 2006 and 2005:
Years
ended
|
$
Differences
|
%
Differences
|
||||||||||||||||||||||||||
2007
|
2006
|
2005
|
2007
to 2006
|
2006
to 2005
|
2007
to 2006
|
2006
to 2005
|
||||||||||||||||||||||
Regenerative cell
technology:
|
||||||||||||||||||||||||||||
Regenerative
cell
technology
|
$ | 12,889,000 | $ | 11,967,000 | $ | 11,487,000 | $ | 922,000 | $ | 480,000 | 7.7 | % | 4.2 | % | ||||||||||||||
Development
milestone (Joint Venture)
|
6,293,000 | 7,286,000 | 1,136,000 | (993,000 | ) | 6,150,000 | (13.6 | )% | 541.4 | % | ||||||||||||||||||
Research
grants
(NIH)
|
— | 479,000 | 306,000 | (479,000 | ) | 173,000 | — | 56.5 | % | |||||||||||||||||||
Stock-based
compensation
|
645,000 | 1,015,000 | 67,000 | (370,000 | ) | 948,000 | (36.5 | )% | 1,414.9 | % | ||||||||||||||||||
Total
regenerative cell technology
|
19,827,000 | 20,747,000 | 12,996,000 | (920,000 | ) | 7,751,000 | (4.4 | )% | 59.6 | % | ||||||||||||||||||
MacroPore
Biosurgery:
|
||||||||||||||||||||||||||||
Bioresorbable
polymer implants
|
111,000 | 1,027,000 | 2,213,000 | (916,000 | ) | (1,186,000 | ) | (89.2 | )% | (53.6 | )% | |||||||||||||||||
Development
milestone (Senko)
|
80,000 | 178,000 | 129,000 | (98,000 | ) | 49,000 | (55.1 | )% | 38.0 | % | ||||||||||||||||||
Stock-based
compensation
|
2,000 | 25,000 | 112,000 | (23,000 | ) | (87,000 | ) | (92.0 | )% | (77.7 | )% | |||||||||||||||||
Total
MacroPore
Biosurgery
|
193,000 | 1,230,000 | 2,454,000 | (1,037,000 | ) | (1,224,000 | ) | (84.3 | )% | (49.9 | )% | |||||||||||||||||
Total
research and development expenses
|
$ | 20,020,000 | $ | 21,977,000 | $ | 15,450,000 | $ | (1,957,000 | ) | $ | 6,527,000 | (8.9 | )% | 42.2 | % |
28
Regenerative
cell technology:
·
|
Regenerative
cell technology expenses relate to the development of a technology
platform that involves using adipose (fat) tissue as a source for
autologous regenerative cells for therapeutic
applications. These expenses, in conjunction with our continued
development efforts related to our Celution™ System platform, result
primarily from the broad expansion of our research and development efforts
enabled by the funding we received from Olympus in 2005 and 2006 and from
other investors in 2006 and 2007. Professional services expense
(which includes pre-clinical and clinical study costs) decreased by
$1,163,000 from 2006 to 2007, of which $422,000 was attributed to a
decrease in pre-clinical and clinical study expense primarily due to a
transition in focus from pre-clinical studies to clinical
studies. Although clinical study costs are expected to exceed
those for pre-clinical studies, they are also typically spread out over a
longer period of time. Rent and utilities expense decreased by
$316,000 from 2006 to 2007 primarily due the termination of leases at our
Top Gun location in San Diego, CA. These decreases were offset
by an increase in travel expense of $389,000 and an increase in repair and
maintenance expense of $382,000 from 2006 to
2007.
|
The
increase in regenerative cell technology expenses from 2005 to 2006 was due
primarily to the hiring of additional researchers, engineers, and support
staff. It was also a result of increased costs for pre-clinical and
clinical studies conducted in 2006 as compared with 2005 as well as increased
rent and utility expense due to the addition of our new facility during the
latter half of 2005.
Expenditures
related to the Joint Venture with Olympus, which are included in the variation
analysis above, include costs that are necessary to support the
commercialization of future generation devices, including the next generation
Celution™ device. These development activities, which began in
November 2005, include performing pre-clinical and clinical studies, seeking
regulatory approval, and performing product development related to therapeutic
applications for adipose stem and regenerative cells for multiple large
markets. For the years ended December 31, 2007, 2006, and 2005, costs
associated with the development of the device were $6,293,000, $7,286,000 and
$1,136,000, respectively. These expenses were composed of $3,217,000,
$3,663,000 and $565,000 in labor and related benefits, $1,973,000, $2,405,000
and $571,000 in consulting and other professional services, $567,000, $872,000
and $0 in supplies and $536,000, $346,000 and $0 in other miscellaneous expense,
respectively.
·
|
In
2004, we entered into an agreement with the NIH to reimburse us for up to
$950,000 (Phase I $100,000 and Phase II $850,000) in “qualifying
expenditures” related to research on Adipose-Derived Cell Therapy for
Myocardial Infarction. For the years ended December 31, 2006 and 2005, we
incurred $479,000 and $306,000, respectively, of direct expenses relating
entirely to Phase I and II. Of these expenses, $169,000 were
not reimbursed in 2006. To date, we have incurred $1,125,000 of
direct expenses ($180,000 of which were not reimbursed) relating to both
Phases I and II of the agreement. There were no comparable
expenditures in 2007 as our work under this NIH agreement was completed
during 2006.
|
·
|
Stock-based
compensation for the regenerative cell technology segment of research and
development was $645,000, $1,015,000 and $67,000 for the years ended
December 31, 2007, 2006 and 2005, respectively. See stock-based
compensation discussion below for more
details.
|
MacroPore
Biosurgery:
·
|
Our
bioresorbable surgical implants platform technology is used for
development of spine and orthopedic products and Thin Film
products. The decrease in research and development costs
associated with bioresorbable implants for the year ended December 31,
2007 as compared with the same period in 2006 and 2005 was due primarily
to our ongoing strategy of reallocating resources toward our regenerative
cell technology segment, as well as to termination of spine and orthopedic
product research upon sale of that product line in May
2007. Labor and related benefits expense, not including
stock-based compensation, decreased by $285,000 for the year ended
December 31, 2007 as compared to 2006. Other notable decreases
from 2006 to 2007 were in rent and utilities of $170,000, repair and
maintenance of $119,000, and depreciation and amortization expense of
$185,000. Decrease from 2005 to 2006 is primarily due to a
decrease in labor and related benefits expense, travel and entertainment,
professional services and depreciation
expense.
|
·
|
Under
a Distribution Agreement with Senko we are responsible for the completion
of the initial regulatory application to the MHLW and commercialization of
the Thin Film product line in Japan. Commercialization occurs
when one or more Thin Film product registrations are completed with the
MHLW. During the years ended December 31, 2007, 2006 and 2005,
we incurred $80,000, $178,000 and $129,000, respectively, of expenses
related to this regulatory and registration
process.
|
29
·
|
Stock-based
compensation for the MacroPore Biosurgery segment of research and
development for the years ended December 31, 2007, 2006, and 2005 was
$2,000, $25,000 and $112,000, respectively. See stock-based
compensation discussion below for more
details.
|
The future: Our
strategy is to continue to increase our research and development efforts in the
regenerative cell field and we anticipate expenditures in this area of research
to total approximately $22,000,000 to $24,000,000 in 2008. We are
researching therapies for cardiovascular disease, new approaches for aesthetic
and reconstructive surgery, gastrointestinal disorders and spine and orthopedic
conditions. The expenditures have and will continue to primarily
relate to developing therapeutic applications and conducting pre-clinical and
clinical studies on adipose-derived stem and regenerative cells.
Sales and marketing
expenses
Sales and
marketing expenses include costs of marketing personnel, tradeshows, and
promotional activities and materials. Medtronic was responsible for
the distribution, marketing and sales support of our spine and orthopedic
devices. The following table summarizes the components of our sales
and marketing expenses for the years ended December 31, 2007, 2006 and
2005:
Years
ended
|
$
Differences
|
%
Differences
|
||||||||||||||||||||||||||
2007
|
2006
|
2005
|
2007
to 2006
|
2006
to 2005
|
2007
to 2006
|
2006
to 2005
|
||||||||||||||||||||||
Regenerative cell
technology:
|
||||||||||||||||||||||||||||
International
sales and marketing
|
$ | 2,231,000 | $ | 1,271,000 | $ | 494,000 | $ | 960,000 | $ | 777,000 | 75.5 | % | 157.3 | % | ||||||||||||||
Stock-based
compensation
|
265,000 | 517,000 | — | (252,000 | ) | 517,000 | (48.7 | )% | — | |||||||||||||||||||
Total
regenerative cell technology
|
2,496,000 | 1,788,000 | 494,000 | 708,000 | 1,294,000 | 39.6 | % | 261.9 | % | |||||||||||||||||||
MacroPore
Biosurgery:
|
||||||||||||||||||||||||||||
General
corporate marketing
|
21,000 | 154,000 | 388,000 | (133,000 | ) | (234,000 | ) | (86.4 | )% | (60.3 | )% | |||||||||||||||||
International
sales and marketing
|
156,000 | 104,000 | 552,000 | 52,000 | (448,000 | ) | 50.0 | % | (81.2 | )% | ||||||||||||||||||
Stock-based
compensation
|
— | 9,000 | 113,000 | (9,000 | ) | (104,000 | ) | — | (92.0 | )% | ||||||||||||||||||
Total
MacroPore Biosurgery
|
177,000 | 267,000 | 1,053,000 | (90,000 | ) | (786,000 | ) | (33.7 | )% | (74.6 | )% | |||||||||||||||||
Total
sales and marketing
|
$ | 2,673,000 | $ | 2,055,000 | $ | 1,547,000 | $ | 618,000 | $ | 508,000 | 30.1 | % | 32.8 | % |
Regenerative
Cell Technology:
·
|
The
increase in international sales and marketing expense for the year ended
December 31, 2007 as compared to same period in 2006 was mainly attributed
to the increase in salary and related benefits expense of $409,000, and
other increases are due to our emphasis in seeking strategic alliances
and/or co-development partners for our regenerative cell
technology.
|
The
increase in international sales and marketing expense for the year ended
December 31, 2006 as compared to same period in 2005 was primarily due to the
increase in salary and related benefits expense of $402,000, increase in
professional services of $71,000, and increase in travel and meals expense of
$106,000.
·
|
Stock-based
compensation for the regenerative cell segment of sales and marketing for
the year ended December 31, 2007 and 2006 was $265,000 and $517,000,
respectively. There was no similar expense in
2005. See stock-based compensation discussion below for more
details.
|
MacroPore
Biosurgery:
·
|
General
corporate marketing expenditures related to expenditures for maintaining
our corporate image and reputation within the research and surgical
communities. Expenditures in this area declined to $21,000 in
2007 as we focused more on our regenerative cell technology business and
exited from our spine and orthopedic implant business. The
decrease from the year ended December 31, 2006 as compared to 2005 was due
to a strategic decision to allocate resources towards our regenerative
cell technology marketing, which in turn prompted a reduction in headcount
in biomaterials and general corporate
marketing.
|
30
·
|
International
sales and marketing expenditures relate to costs associated with
developing an international bioresorbable Thin Film distributor and
supporting a bioresorbable Thin Film sales office in Japan. The
decreased spending in 2006 as compared to 2005 relates to a significant
headcount decrease in this marketing group as MHLW approval for
commercialization has been delayed from our original
expectation.
|
·
|
Stock-based
compensation for the MacroPore Biosurgery segment of sales and marketing
for the years ended December 31, 2007, 2006 and 2005 was $0, $9,000 and
$113,000, respectively. See stock-based compensation discussion
below for more details.
|
The future. We
expect sales and marketing expenditures related to regenerative cell technology
to increase as we continue to expand our pursuit of strategic alliances and
co-development partners, and market our Celution™ 800 CRS and StemSource™ Cell
Bank in 2008.
General and administrative
expenses
General
and administrative expenses include costs for administrative personnel, legal
and other professional expenses and general corporate expenses. The
following table summarizes the general and administrative expenses for the years
ended December 31, 2007, 2006 and 2005:
Years
ended
|
$
Differences
|
%
Differences
|
||||||||||||||||||||||||||
2007
|
2006
|
2005
|
2007
to 2006
|
2006
to 2005
|
2007
to 2006
|
2006
to 2005
|
||||||||||||||||||||||
General
and administrative
|
$ | 12,805,000 | $ | 10,967,000 | $ | 10,096,000 | $ | 1,838,000 | $ | 871,000 | 16.8 | % | 8.6 | % | ||||||||||||||
Stock-based
compensation
|
1,379,000 | 1,580,000 | 112,000 | (201,000 | ) | 1,468,000 | (12.7 | )% | 1,310.7 | % | ||||||||||||||||||
Total
general and administrative expenses
|
$ | 14,184,000 | $ | 12,547,000 | $ | 10,208,000 | $ | 1,637,000 | $ | 2,339,000 | 13.0 | % | 22.9 | % |
·
|
General
and administrative expense, for the year ended December 31, 2007 as
compared to the same period in 2006 increased by
$1,637,000. This was primarily a result of increases in salary
and related benefit expense of $802,000 and increases in professional
services of $1,160,000, offset by a decrease in stock-based compensation
of $201,000 for the year ended December 31, 2007 as compared with
2006. The increase in salary and related benefit expense was
mainly attributed to an increase in headcount. The increase in
professional services was mainly attributed to an increase of $266,000 in
consulting services, increases in accounting fees of $196,000, and an
increase in legal expenses of $863,000, partly incurred in connection with
the University of Pittsburgh’s lawsuit challenging the inventorship of our
licensor’s U.S. patent relating to adult stem cells isolated from adipose
tissue, offset by a decrease in other professional services of
$165,000. In addition, we incurred a non-recurring fee of
$322,000 related to our February 2007 sale of common
stock.
|
General
and administrative expense, for the year ended December 31, 2006 as compared to
the same period in 2005 increased by $2,339,000. This was primarily a
result of increased stock-based compensation of $1,468,000 as well as increases
in other salary and related benefit expense of $677,000. The increase
in salary and related benefit expense was mainly attributed to an increase in
headcount. Professional services for the year ended December 31, 2006
as compared with 2005 increased by $935,000, which includes an increase of
$777,000 in legal expenses, partly incurred in connection with the University of
Pittsburgh’s lawsuit challenging the inventorship of our licensor’s U.S. patent
relating to adult stem cells isolated from adipose tissue. Also
contributing $487,000 to the increase in legal expense was the issuance of
100,000 shares of stock to the Regents of the University of California (“UC”) at
a stock price of $4.87 per share pursuant to an amended technology license
agreement that was finalized in the third quarter of 2006.
·
|
In
the second and fourth quarters of 2006, we recorded an additional $118,000
and $103,000 of depreciation expense to accelerate the estimated remaining
lives for furniture and fixtures no longer in use due to our relocation as
well as outdated computer software and related equipment. We
also recorded a charge to general and administrative expenses in the
fourth quarter of 2006 related to leasehold improvements that had a
shortened useful life due to the termination of one of our
leases.
|
·
|
Stock-based
compensation related to general and administrative expense for the years
ended December 31, 2007, 2006 and 2005 was $1,379,000, $1,580,000 and
$112,000, respectively. See stock-based compensation discussion
below for more details.
|
31
The future. We
expect general and administrative expenses of approximately $10,000,000 to
$12,000,000 in 2008. We are seeking ways to minimize the ratio of
these expenses to research and development expenses. As a result, we
have begun efforts to restrain general and administrative expense.
We have
incurred, and expect to continue to incur, substantial legal expenses in
connection with the University of Pittsburgh’s 2004 lawsuit. Although
we are not litigants and are not responsible for any settlement costs, if the
University of Pittsburgh wins the lawsuit our license rights to the patent in
question could be nullified or rendered non-exclusive and our regenerative cell
strategy could be affected. The amended UC license agreement signed
in the third quarter of 2006 clarified that we are responsible for all patent
prosecution and litigation costs related to this lawsuit.
Stock-based compensation
expenses
As noted
previously, we adopted SFAS 123R on January 1, 2006. 2005 period
figures have not been restated and therefore are not comparable to the 2006 and
2007 presentation.
Stock-based
compensation expenses include charges related to options issued to employees,
directors and non-employees. Prior to January 1, 2006, the
stock-based compensation expenditures connected to options granted to employees
and directors (in their capacity as board members) is the difference between the
exercise price of the stock based awards and the market value of our underlying
common stock on the date of the grant. Unearned employee stock-based
compensation is amortized over the remaining vesting periods of the options,
which generally vest over a four-year period from the date of
grant. From January 1, 2006 onwards, we adopted FASB No. 123 (revised
2004), “Share-based payments.” Under this pronouncement, we measure
stock-based compensation expense based on the grant-date fair value of any
awards granted to our employees. Such expense is recognized over the
period of time that employees provide service to us and earn all rights to the
awards.
Stock-based
compensation expense related to common stock issued to non-employees is the fair
value of the stock on the date of issuance, even if such stock contains sales
restrictions. The following table summarizes the components of our
stock-based compensation for the years ended December 31, 2007, 2006 and
2005:
Years
ended
|
$
Differences
|
%
Differences
|
||||||||||||||||||||||||||
2007
|
2006
|
2005
|
2007
to 2006
|
2006
to 2005
|
2007
to 2006
|
2006
to 2005
|
||||||||||||||||||||||
Regenerative cell
technology:
|
||||||||||||||||||||||||||||
Research
and development related
|
$ | 645,000 | $ | 1,015,000 | $ | 67,000 | $ | (370,000 | ) | $ | 948,000 | (36.5 | )% | 1,414.9 | % | |||||||||||||
Sales
and marketing related
|
265,000 | 517,000 | — | (252,000 | ) | 517,000 | (48.7 | )% | — | |||||||||||||||||||
Total
regenerative cell technology
|
910,000 | 1,532,000 | 67,000 | (622,000 | ) | 1,465,000 | (40.6 | )% | 2,186.6 | % | ||||||||||||||||||
MacroPore
Biosurgery:
|
||||||||||||||||||||||||||||
Cost
of product revenues
|
19,000 | 74,000 | — | (55,000 | ) | 74,000 | (74.3 | )% | — | |||||||||||||||||||
Research
and development related
|
2,000 | 25,000 | 112,000 | (23,000 | ) | (87,000 | ) | (92.0 | )% | (77.7 | )% | |||||||||||||||||
Sales
and marketing related
|
— | 9,000 | 113,000 | (9,000 | ) | (104,000 | ) | — | (92.0 | )% | ||||||||||||||||||
Total
MacroPore Biosurgery
|
21,000 | 108,000 | 225,000 | (87,000 | ) | (117,000 | ) | (80.6 | )% | (52.0 | )% | |||||||||||||||||
General
and administrative related
|
1,379,000 | 1,580,000 | 112,000 | (201,000 | ) | 1,468,000 | (12.7 | )% | 1,310.7 | % | ||||||||||||||||||
Total
stock-based compensation
|
$ | 2,310,000 | $ | 3,220,000 | $ | 404,000 | $ | (910,000 | ) | $ | 2,816,000 | (28.3 | )% | 697.0 | % |
Regenerative
cell technology:
·
|
Of
the $910,000 charge to stock-based compensation for the year ended
December 31, 2007, $6,000 related to award modifications for the
termination of the employment of our Vice President of Research,
Regenerative Cell Technology. The charge reflects the incremental fair
value of (a) the accelerated unvested stock options and (b) the extended
vested stock options (over the fair value of the original awards at the
modification date). There will be no further charges related
these modifications.
|
·
|
In
the first quarter of 2006, we issued 2,500 shares of restricted common
stock to a non-employee scientific advisor. Similarly, in the
second quarter of 2005, we issued 20,000 shares of restricted common stock
to a non-employee scientific advisor. The stock is restricted
in that it cannot be sold for a specified period of time. There
are no vesting requirements. Because the shares issued are not
subject to additional future vesting or service requirements, the
stock-based compensation expense of $18,000 recorded in the first quarter
of 2006 (and $63,000 recorded in the second quarter of 2005) constitutes
the entire expense related to these grants, and no future period charges
will be reported. The scientific advisors also receive cash
consideration as services are
performed.
|
32
General
and Administrative:
·
|
During
the first quarter of 2007, we issued to our officers and directors stock
options to purchase up to 410,000 shares of our common stock, with a
four-year vesting schedule for our officers and 24-month graded vesting
for our directors. The grant date fair value of option awards granted to
our officers and directors was $3.82 and $3.70 per share, respectively.
The resulting share-based compensation expense of $1,480,000, net of
estimated forfeitures, will be recognized as expense over the respective
vesting periods.
|
·
|
Of
the $1,379,000 charge to stock-based compensation for the year ended
December 31, 2007, $58,000 related to award modifications for the
termination of the employment of two employees. The charge
reflects the incremental fair value of (a) the accelerated unvested stock
options and (b) the extended vested stock options (over the fair value of
the original awards at the modification date). There will be no
further charges related these
modifications.
|
During
the second quarter of 2007, we made company-wide stock option grants to our
non-executive employees to purchase 213,778 shares of our common stock, subject
to a four-year graded vesting schedule. The grant date fair value for the awards
was $3.65 per share. The resulting share-based compensation expense of $739,000,
net of estimated forfeitures, will be recognized as expense over the respective
vesting periods.
Of the
$3,220,000 charge to stock-based compensation for the year ended December 31,
2006, $420,000 related to extensions and cancellations of awards previously
granted to (a) our former Senior Vice President of Finance and Administration,
who retired in May 2006, and (b) (i) our former Senior Vice President, Business
Development, (ii) our former Vice President, Marketing and Development, and
(iii) the position of a less senior employee, whose positions were eliminated
during 2006. The charge reflects the incremental fair value of the
extended vested stock options over the fair value of the original awards at the
modification date as well as the acceleration of unrecognized compensation cost
associated with cancelled option awards that would have been recognized if the
four individuals continued to vest in their options until the end of their
employment term. There will be no further charges related to these
modifications.
In August
2005, our Chief Operating Officer (“COO”) ceased employment with
us. We agreed to pay the former COO a lump sum cash severance payment
of $155,164 and extended the exercise period for two years on 253,743 vested
stock options. The incremental value of the options due to the
modification was $337,000. We recorded an expense in the third
quarter of 2005 to reflect the lump sum cash severance payment and the value of
the vested stock options, which constitutes the entire expense related to these
options, and no future period charges will be required. This $337,000
was allocated in the table above in equal portions among three departmental
categories, consistent with previous allocations of the former COO’s
compensation expense.
The future. We
will continue to grant options (which will result in an expense) to our
employees and, as appropriate, to non-employee service providers. In
addition, previously-granted options will continue to vest in accordance with
their original terms. As of December 31, 2007, the total compensation
cost related to non-vested stock options not yet recognized for all our plans is
approximately $4,623,000. These costs are expected to be recognized over a
weighted average period of 1.86 years.
Change in fair value of
option liabilities
The
following is a table summarizing the change in fair value of option liabilities
for the years ended December 31, 2007, 2006 and 2005:
Years
ended
|
$
Differences
|
%
Differences
|
||||||||||||||||||||||||||
2007
|
2006
|
2005
|
2007
to 2006
|
2006
to 2005
|
2007
to 2006
|
2006
to 2005
|
||||||||||||||||||||||
Change
in fair value of option liability.
|
$ | — | $ | (3,731,000 | ) | $ | 3,545,000 | $ | 3,731,000 | $ | (7,276,000 | ) | — | (205.2 | )% | |||||||||||||
Change
in fair value of put option liability
|
100,000 | (700,000 | ) | 100,000 | 800,000 | (800,000 | ) | (114.3 | )% | (800.0 | )% | |||||||||||||||||
Total
change in fair value of option liabilities.
|
$ | 100,000 | $ | (4,431,000 | ) | $ | 3,645,000 | $ | 4,531,000 | $ | (8,076,000 | ) | (102.3 | )% | (221.6 | )% |
33
·
|
We
granted Olympus an option to acquire 2,200,000 shares of our common stock
in 2005. The exercise price of the option shares was $10 per
share. We had accounted for this grant as a liability because
had the option been exercised, we would have been required to deliver
listed shares of our common stock to settle the option
shares. In accordance with EITF 00-19, “Accounting for
Derivative Financial Instruments Indexed to, and Potentially Settled in, a
Company’s Own Stock,” the fair value of this option was re-measured at the
end of each quarter, using the Black-Scholes option pricing model, with
the movement in fair value reported in the statement of operations as a
change in fair value of option liabilities. This option expired
unexercised on December 31, 2006.
|
·
|
In
reference to the Joint Venture, the Shareholders’ Agreement between Cytori
and Olympus provides that in certain specified circumstances of insolvency
or if we experience a change in control, Olympus will have the rights to
(i) repurchase our interests in the Joint Venture at the fair value of
such interests or (ii) sell its own interests in the Joint Venture to us
at the higher of (a) $22,000,000 or (b) the Put’s fair
value. The value of the Put has been classified as a
liability.
|
The
valuations of the Put were completed using an option pricing theory based
simulation analysis (i.e., a Monte Carlo simulation). The valuations
are based on assumptions as of the valuation date with regard to the market
value of Cytori and the estimated fair value of the Joint Venture, the expected
correlation between the values of Cytori and the Joint Venture, the expected
volatility of Cytori and the Joint Venture, the bankruptcy recovery rate for
Cytori, the bankruptcy threshold for Cytori, the probability of a change of
control event for Cytori, and the risk free interest rate.
The
following assumptions were employed in estimating the value of the
Put:
December
31, 2007
|
December
31, 2006
|
December
31, 2005
|
||||||||||
Expected
volatility of Cytori
|
60.00 | % | 66.00 | % | 63.20 | % | ||||||
Expected
volatility of the Joint Venture
|
60.00 | % | 56.60 | % | 69.10 | % | ||||||
Bankruptcy
recovery rate for Cytori
|
21.00 | % | 21.00 | % | 21.00 | % | ||||||
Bankruptcy
threshold for Cytori
|
$ | 9,324,000 | $ | 10,110,000 | $ | 10,780,000 | ||||||
Probability
of a change of control event for Cytori
|
2.17 | % | 1.94 | % | 3.04 | % | ||||||
Expected
correlation between fair values of Cytori and the Joint Venture in the
future
|
99.00 | % | 99.00 | % | 99.00 | % | ||||||
Risk
free interest rate
|
4.04 | % | 4.71 | % | 4.39 | % |
The future. The
Put has no expiration date. Accordingly, we will continue to
recognize a liability for the Put until it is exercised or until the
arrangements with Olympus are amended.
Other income
(expense)
The
following table summarizes the gain on sale of assets for the years ended
December 31, 2007, 2006 and 2005:
Years
ended
|
$
Differences
|
%
Differences
|
||||||||||||||||||||||||||
2007
|
2006
|
2005
|
2007
to
2006
|
2006
to
2005
|
2007
to
2006
|
2006
to
2005
|
||||||||||||||||||||||
Gain
on sale of
assets
|
$ | 1,858,000 | $ | — | $ | 5,526,000 | $ | 1,858,000 | $ | (5,526,000 | ) | — | — | |||||||||||||||
Total
|
$ | 1,858,000 | $ | — | $ | 5,526,000 | $ | 1,858,000 | $ | (5,526,000 | ) | — | — |
·
|
In
May 2007, we sold to Kensey Nash our intellectual property rights and
tangible assets related to our spine and orthopedic bioresorbable implant
product line, a part of our MacroPore Biosurgery
business. Excluded from the sale was our Japan Thin Film
product line. We received $3,175,000 in cash related to the
disposition. The assets comprising the spine and orthopedic
product line transferred to Kensey Nash were as
follows:
|
Carrying
Value Prior to Disposition
|
||||
Inventory
|
$ | 94,000 | ||
Other
current assets
|
17,000 | |||
Assets
held for sale
|
436,000 | |||
Goodwill
|
465,000 | |||
$ | 1,012,000 |
34
We
incurred expenses of $109,000 in connection with the sale during the second
quarter of 2007. As part of the disposition agreement, we were
required to provide training to Kensey Nash representatives in all aspects of
the manufacturing process related to the transferred spine and orthopedic
product line, and to act in the capacity of a product manufacturer from the
point of sale through August 2007. Because of these additional
manufacturing requirements, we deferred $196,000 of the gain related to the
outstanding manufacturing requirements, and we recognized $1,858,000 as a gain
on sale in the statement of operations during the second quarter of
2007. These manufacturing requirements were completed in August as
planned, and the associated costs were classified against the deferred balance,
reducing it to zero. As of December 31, 2007, no further costs or
adjustments relating to this product line sale are anticipated.
The
revenues and expenses related to the spine and orthopedic product line
transferred to Kensey Nash for the years ended December 31, 2007, 2006 and 2005
were as follows:
For
the years ended December 31,
|
||||||||||||
2007
|
2006
|
2005
|
||||||||||
Revenues
|
$ | 792,000 | $ | 1,451,000 | $ | 5,634,000 | ||||||
Cost
of product revenues
|
(422,000 | ) | (1,634,000 | ) | (3,154,000 | ) | ||||||
Research
& development
|
(113,000 | ) | (1,052,000 | ) | (2,325,000 | ) | ||||||
Sales
& marketing
|
(21,000 | ) | (163,000 | ) | (501,000 | ) |
·
|
The
$5,526,000 gain on sale of assets recorded in the third quarter of 2005
was related to the sale of the majority of our Thin Film product line in
May 2004 to MAST. As part of the disposal arrangement, we
agreed to complete certain performance obligations which prevented us from
recognizing the gain on sale of assets when the cash was initially
received. In August 2005, following the settlement of
arbitration proceedings related to the sale agreement, we were able to
recognize the gain on sale of assets of $5,650,000, less $124,000 of
related deferred costs, in the statement of
operations.
|
The future. No
additional gains will be recognized related to either sale.
Financing
items
The
following table summarizes interest income, interest expense, and other income
and expenses for the years ended December 31, 2007, 2006, and 2005:
Years
ended
|
$
Differences
|
%
Differences
|
||||||||||||||||||||||||||
2007
|
2006
|
2005
|
2007
to 2006
|
2006
to 2005
|
2007
to 2006
|
2006
to 2005
|
||||||||||||||||||||||
Interest
income
|
$ | 1,028,000 | $ | 708,000 | $ | 299,000 | $ | 320,000 | $ | 409,000 | 45.2 | % | 136.8 | % | ||||||||||||||
Interest
expense
|
(155,000 | ) | (199,000 | ) | (137,000 | ) | 44,000 | (62,000 | ) | (22.1 | )% | 45.3 | % | |||||||||||||||
Other
income (expense)
|
(46,000 | ) | (27,000 | ) | (55,000 | ) | (19,000 | ) | 28,000 | 70.4 | % | (50.9 | )% | |||||||||||||||
Total
|
$ | 827,000 | $ | 482,000 | $ | 107,000 | $ | 345,000 | $ | 375,000 | 71.6 | % | 350.5 | % |
·
|
Interest
income increased in 2007 as compared to 2006 due to a larger balance of
funds available for investment, as a result of (i) the sale of common
stock and common stock warrants under the shelf registration statement in
February 2007, (ii) proceeds from the common stock private placement to
Green Hospital Supply, Inc. in April 2007, and (iii) proceeds from the
sale of our bioresorbable spine and orthopedic surgical implant product
line to Kensey Nash in May 2007. Interest income increased in
2006 as compared to 2005 due to a larger balance of funds available for
investment, which was a result of the transactions with Olympus, as well
as the sale of common stock in the third quarter of
2006.
|
·
|
Interest
expense decreased in 2007 as compared to 2006 due to the lower principal
balances on our long-term equipment-financed borrowings as we repay our
promissory notes. Interest expense increased in 2006 as
compared to 2005 due to higher principal balances on our long-term
equipment-financed borrowings. In late 2005, we executed an
additional promissory note, with approximately $1,380,000 in principal.
Our most recent promissory note, with approximately $600,000 in principal,
was executed in December 2006.
|
·
|
The
changes in other income (expense) in 2007, 2006 and 2005 resulted
primarily from changes in foreign currency exchange
rates.
|
35
The
future. Interest income earned in 2008 will be dependent
on our levels of funds available for investment as well as general economic
conditions. We expect interest expense to decrease slightly in 2008
as we continue to repay the promissory note balances.
Equity loss from investment
in Joint Venture
The
following table summarizes equity loss from investment in joint venture for the
years ended December 31, 2007, 2006, and 2005:
Years
ended
|
$
Differences
|
%
Differences
|
||||||||||||||||||||||||||
2007
|
2006
|
2005
|
2007
to
2006
|
2006
to
2005
|
2007
to
2006
|
2006
to
2005
|
||||||||||||||||||||||
Equity
loss from investment in joint venture
|
$ | (7,000 | ) | $ | (74,000 | ) | $ | (4,172,000 | ) | $ | 67,000 | $ | 4,098,000 | (90.5 | )% | (98.2 | )% |
The
losses relate entirely to our 50% equity interest in the Joint Venture, which we
account for using the equity method of accounting. The 2005 loss
related to the payment, of a portion of the original capital which Olympus
invested in the Joint Venture, back to Olympus, in exchange for a development
services agreement.
The future. We do
not expect to recognize significant losses from the activities of the Joint
Venture in the foreseeable future. Over the next two to three years,
the Joint Venture is expected to incur labor costs related to the development of
our second generation commercial system as well as general and administrative
expenses, offset by royalty income expected to begin in 2008 when Cytori
commercializes its Celution™ 800/CRS in Europe and Celution™ 900-based
StemSource™ Cell Bank in Japan. Though we have no obligation to
do so, we and Olympus plan to jointly fund the Joint Venture to cover any costs
should the Joint Venture deplete its cash balance.
Liquidity
and Capital Resources
Short-term and long-term
liquidity
The
following is a summary of our key liquidity measures at December 31, 2007, 2006,
and 2005:
Years
ended
|
$
Differences
|
%
Differences
|
||||||||||||||||||||||||||
2007
|
2006
|
2005
|
2007
to 2006
|
2006
to 2005
|
2007
to 2006
|
2006
to 2005
|
||||||||||||||||||||||
Cash
and cash equivalents
|
$ | 11,465,000 | $ | 8,902,000 | $ | 8,007,000 | $ | 2,563,000 | $ | 895,000 | 28.8 | % | 11.2 | % | ||||||||||||||
Short-term
investments, available for sale
|
— | 3,976,000 | 7,838,000 | (3,976,000 | ) | (3,862,000 | ) | — | (49.3 | )% | ||||||||||||||||||
Total
cash and cash equivalents and short-term investments, available for
sale
|
$ | 11,465,000 | $ | 12,878,000 | $ | 15,845,000 | $ | (1,413,000 | ) | $ | (2,967,000 | ) | (11.0 | )% | (18.7 | )% | ||||||||||||
Current
assets
|
$ | 12,238,000 | $ | 13,978,000 | $ | 17,540,000 | $ | (1,740,000 | ) | $ | (3,562,000 | ) | (12.4 | )% | (20.3 | )% | ||||||||||||
Current
liabilities
|
8,070,000 | 6,586,000 | 7,081,000 | 1,484,000 | (495,000 | ) | 22.5 | % | (7.0 | )% | ||||||||||||||||||
Working
capital
|
$ | 4,168,000 | $ | 7,392,000 | $ | 10,459,000 | $ | (3,224,000 | ) | $ | (3,067,000 | ) | (43.6 | )% | (29.3 | )% |
In order
to provide greater financial flexibility and liquidity, and in view of the
substantial cash needs of our regenerative cell business during its development
stage, we have an ongoing need to raise additional capital. In the
third quarter of 2006, we received net proceeds of $16,219,000 from the sale of
common stock pursuant to a shelf registration statement, of which Olympus
purchased $11,000,000; the remaining shares were purchased by other
institutional investors. Additionally, in the first quarter of 2007,
we received net proceeds of $19,901,000 from the sale of units consisting of
3,746,000 shares of common stock and 1,873,000 common stock warrants (with an
exercise price of $6.25 per share) under the shelf registration statement.
In the second quarter of 2007, we received net proceeds of $6,000,000 from the
sale of 1,000,000 shares of common stock to Green Hospital Supply, Inc. in a
private placement. Also, in the second quarter of 2007, we
successfully divested our spine and orthopedic product line to Kensey Nash for
gross proceeds of $3,175,000.
With
consideration of these endeavors as well as existing funds, additional capital
will need to be raised during 2008 through the operations, and other accessible
sources of financing, to provide us adequate cash to satisfy our working
capital, capital expenditures, debt service and other financial commitments at
least through December 31, 2008. On February 8, 2008, we entered into
an agreement to sell 2,000,000 shares of common stock at $6.00 per share to
Green Hospital Supply, Inc. in a private placement. On February 29,
2008 we closed the first half of the private placement with Green Hospital
Supply, Inc. and received $6,000,000. We have agreed to close the second half of
the private placement on or before April 30, 2008.
36
The
Company expects to utilize its cash and cash equivalents to fund its operations,
including research and development of its products primarily for development and
pre-clinical activities and for clinical trials. Additionally, the Company
believes that without additional capital from operations and other accessible
sources of financing it does not currently have adequate funding to complete the
development, preclinical activities and clinical trials required to bring its
future products to market, therefore, it will require significant additional
funding. If the Company is unsuccessful in its efforts to raise additional
funds through accessible sources of financing, strategic relationships or
through revenue sources, it will be required to significantly reduce or curtail
its research and development activities and other operations. Management
actively monitors cash expenditures and projected expenditures as we progress
toward our goals of product commercialization and sales in an effort to match
projected expenditures to available cash flow.
From inception to December 31, 2007, we have financed our operations primarily by:
·
|
Issuing
stock in pre-IPO transactions, a 2000 initial public offering in Germany,
and stock option exercises,
|
·
|
Generating
revenues,
|
·
|
Selling
the bioresorbable implant CMF product line in September
2002,
|
·
|
Selling
the bioresorbable implant Thin Film product line (except for the territory
of Japan), in May 2004,
|
·
|
Licensing
distribution rights to Thin Film in Japan, in exchange for an upfront
license fee in July 2004 and an initial development milestone payment in
October 2004,
|
·
|
Obtaining
a modest amount of capital equipment long-term
financing,
|
·
|
Selling
1,100,000 shares of common stock to Olympus under an agreement which
closed in May 2005,
|
·
|
Upfront
and milestone fees from our Joint Venture with Olympus, which was entered
into in November 2005,
|
·
|
Receiving
funds in exchange for granting Olympus an exclusive right to negotiate in
February 2006,
|
·
|
$16,219,000
in net proceeds from a common stock sale under the shelf registration
statement in August 2006,
|
·
|
$19,901,000
in net proceeds from the sale of common stock plus common stock warrants
under the shelf registration statement in February
2007,
|
·
|
$6,000,000
in net proceeds from a private placement to Green Hospital Supply, Inc. in
April 2007, and
|
·
|
Receiving
gross proceeds of $3,175,000 from the sale of our bioresorbable spine and
orthopedic surgical implant product line to Kensey Nash in May
2007.
|
We
entered into a strategic development and manufacturing joint venture as well as
other agreements with Olympus in November 2005. Under the
collaborative arrangements, we formed the Joint Venture with Olympus to develop
and manufacture future generation devices based on our Celution™ System
platform. Pursuant to the terms of the agreements, we received
$11,000,000 in cash upon closing in the fourth quarter of 2005; this cash is
incremental to the proceeds received under the May 2005 Olympus equity
investment.
In
January 2006, we also received an additional $11,000,000 upon our receipt of a
CE mark for the Celution™ 600 and received an additional $1,500,000 in the first
half of 2006 in exchange for the grant to Olympus of an exclusive right to
negotiate a commercialization collaboration for the use of adipose stem and
regenerative cells for a specific therapeutic area outside of cardiovascular
disease.
In August
2006, we sold 2,918,000 shares of our common stock at $5.75 per share for an
aggregate of approximately $16,800,000. Olympus purchased $11,000,000
of these shares and the remaining balance was purchased by certain institutional
investors. We received proceeds of $16,219,000, net of related
offering costs and fees.
37
In
February 2007, we sold units consisting of 3,746,000 shares of common stock and
1,873,000 common stock warrants (with an exercise price of $6.25 per share) to
institutional and accredited investors. We received proceeds of
approximately $19,901,000, net of related offering costs and fees.
We
received net proceeds of $6,000,000 from the sale of 1,000,000 shares of common
stock to Green Hospital Supply, Inc. in a private placement in April
2007.
In May
2007, we successfully divested our spine and orthopedic product line to Kensey
Nash for gross proceeds of $3,175,000.
We don’t
expect significant capital expenditures in 2008; however, if necessary, we may
borrow under our Amended Master Security Agreement.
Any
excess funds will be invested in short-term available-for-sale
investments.
Our cash
requirements for 2008 and beyond will depend on numerous factors, including the
resources we devote to developing and supporting our investigational cell
therapy products, market acceptance of any developed products, regulatory
approvals and other factors. We expect to incur research and
development expenses at high levels in our regenerative cell platform for an
extended period of time and have therefore positioned ourselves to expand our
cash position through actively pursuing co-development and marketing agreements,
research grants, and licensing agreements related to our regenerative cell
technology platform.
The
following summarizes our contractual obligations and other commitments at
December 31, 2007, and the effect such obligations could have on our liquidity
and cash flow in future periods:
Payments
due by period
|
||||||||||||||||||||
Contractual
Obligations
|
Total
|
Less
than 1
year
|
1
– 3 years
|
3
– 5 years
|
More
than
5
years
|
|||||||||||||||
Long-term
obligations
|
$ | 958,000 | $ | 721,000 | $ | 237,000 | $ | — | $ | — | ||||||||||
Interest
commitment on long-term obligations
|
83,000 | 68,000 | 15,000 | — | — | |||||||||||||||
Operating
lease obligations
|
4,029,000 | 1,696,000 | 2,333,000 | — | — | |||||||||||||||
Pre-clinical
research study obligations
|
196,000 | 196,000 | — | — | — | |||||||||||||||
Clinical
research study obligations
|
9,295,000 | 4,155,000 | 4,740,000 | 400,000 | — | |||||||||||||||
Total
|
$ | 14,561,000 | $ | 6,836,000 | $ | 7,325,000 | $ | 400,000 | $ | — |
Net cash
(used in) provided by operating, investing and financing activities for the
years ended December 31, 2007, 2006 and 2005, is summarized as
follows:
Years
Ended
|
||||||||||||
2007
|
2006
|
2005
|
||||||||||
Net
cash used in operating activities
|
$ | (29,995,000 | ) | $ | (16,483,000 | ) | $ | (1,101,000 | ) | |||
Net
cash provided by investing activities
|
5,982,000 | 591,000 | 911,000 | |||||||||
Net
cash provided by financing activities
|
26,576,000 | 16,787,000 | 5,357,000 |
Operating
activities
Net cash
used in operating activities for all periods presented resulted primarily from
expenditures related to our regenerative cell research and development
efforts.
Research
and development efforts, other operational activities, and a comparatively small
amount of product sales generated a $28,672,000 net loss for the year ended
December 31, 2007. The cash impact of this loss was $29,995,000,
after adjusting for the $5,158,000 of deferred revenue, related party,
recognized in 2007, for which cash was received in earlier years, $1,858,000 of
gain on sale of assets, $1,616,000 of non-cash depreciation and $2,310,000
non-cash stock based compensation expense, along with other changes in working
capital due to timing of product shipments (accounts receivable) and payment of
liabilities.
38
Research
and development efforts, other operational activities, and a comparatively small
amount of product sales generated a $25,447,000 net loss for the year ended
December 31, 2006. The cash impact of this loss was $16,483,000,
after adjusting for the $11,000,000 cash we received in 2006 from the Joint
Venture upon obtaining the CE Mark in the first quarter of 2006, the $1,500,000
received from Olympus mentioned above, $2,120,000 of non-cash depreciation and
amortization, $3,220,000 non-cash stock based compensation expense, and
$4,431,000 non-cash change in the fair value of option liabilities, along with
other changes in working capital due to timing of product shipments and payment
of liabilities.
Research
and development efforts, other operational activities, and a comparatively small
amount of product sales generated a $26,538,000 net loss for the year ended
December 31, 2005. The cash impact of this loss was $1,101,000, after
adjusting for the $17,311,000 we received from Olympus as discussed
previously. Other adjustments include material non-cash activities,
such as the gain on sale of assets, depreciation and amortization, changes in
the fair value of the Olympus option liabilities, stock based compensation
expense, equity loss from investment in Joint Venture, as well as for changes in
working capital due to the timing of product shipments and payment of
liabilities.
Investing
activities
Net cash
provided by investing activities for the year ended December 31, 2007 resulted
primarily from net proceeds from the purchase and sale of short-term investments
and proceeds from the sale of assets, offset in part by expenditures for
leasehold improvements.
Net cash
provided by investing activities for the year ended December 31, 2006 and 2005
resulted primarily from net proceeds from the purchase and sale of short-term
investments, offset in part by expenditures for leasehold
improvements.
Capital
spending is essential to our product innovation initiatives and to maintain our
operational capabilities. For the years ended December 31, 2007, 2006
and 2005, we used cash to purchase $563,000, $3,138,000 and $1,846,000,
respectively, of property and equipment to support manufacturing of our
bioresorbable implants and for the research and development of the regenerative
cell technology platform. The increase in 2006 capital spending was
caused primarily by expenditures for leasehold improvements made to our new
facilities.
Financing
Activities
The net
cash provided by financing activities for the year ended December 31, 2007
related mainly to the issuance of common stock and common stock warrants under
the shelf registration statement in exchange for net proceeds of $19,901,000 and
a common stock private placement made with Green Hospital Supply, Inc. for net
proceeds of $6,000,000. Net cash proceeds provided by financing
activities also consisted of proceeds from the exercise of employee stock
options, offset to some extent by principal payments on long-term
obligations.
The net
cash provided by financing activities for the year ended December 31, 2006
related mainly to the issuance of 2,918,255 shares of our common stock in
exchange for $16,219,000, net of related expenses. Net cash provided
by financing activities also comprised from proceeds from the exercise of
employee stock options, offset by principal payments on long-term
obligations.
The net
cash provided by financing activities for the year ended December 31, 2005
related mainly to the proceeds received from Olympus as noted
above. Sale proceeds consisted of $3,003,000 for the sale of common
stock and $1,686,000 for the issuance of options. Net cash proceeds
provided by financing activities also consisted of proceeds from the exercise of
employee stock options as well as proceeds from the promissory note
borrowings.
Critical
Accounting Policies and Significant Estimates
The
preparation of financial statements in conformity with accounting principles
generally accepted in the United States requires us to make estimates and
assumptions that affect the reported amounts of our assets, liabilities,
revenues and expenses, and that affect our recognition and disclosure of
contingent assets and liabilities.
While our
estimates are based on assumptions we consider reasonable at the time they were
made, our actual results may differ from our estimates, perhaps
significantly. If results differ materially from our estimates, we
will make adjustments to our financial statements prospectively as we become
aware of the necessity for an adjustment.
We
believe it is important for you to understand our most critical accounting
policies. These are our policies that require us to make our most
significant judgments and, as a result, could have the greatest impact on our
future financial results.
39
Revenue
Recognition
We derive
our revenue from a number of different sources, including but not limited
to:
·
|
Fees
for achieving certain defined milestones under research and/or development
arrangements.
|
·
|
Product
sales, and
|
·
|
Payments
under license or distribution
agreements.
|
A number
of our revenue generating arrangements are relatively simple in nature, meaning
that there is little judgment necessary with regard to the timing of when we
recognize revenues or how such revenues are presented in the financial
statements.
However,
we have also entered into more complex arrangements, including but not limited
to our contracts with Olympus, Senko, and the NIH. Moreover, some of
our non-recurring transactions, such as our disposition of the majority of our
Thin Film business to MAST, contain elements that relate to our revenue
producing activities.
As a
result, some of our most critical accounting judgments relate to the
identification, timing, and presentation of revenue related activities. These
critical judgments are as follows:
Multiple-element
arrangements
Some of
our revenue generating arrangements contains a number of distinct revenue
streams, known as “elements.” For example, our Distribution Agreement
with Senko contains direct or indirect future revenue streams related
to:
·
|
A
distribution license fee (which was paid at the outset of the
arrangement),
|
·
|
Milestone
payments for achieving commercialization of the Thin Film product line in
Japan,
|
·
|
Training
for representatives of Senko,
|
·
|
Sales
of Thin Film products to Senko, and
|
·
|
Payments
in the nature of royalties on future product sales made by Senko to its
end customers.
|
Emerging
Issues Task Force Issue 00-21, “Revenue Arrangements with Multiple Deliverables”
(“EITF 00-21”), governs whether each of the above elements in the arrangement
should be accounted for individually, or whether the entire contract should be
treated as a single unit of accounting.
EITF
00-21 indicates that individual elements may be separately accounted for only
when:
·
|
The
delivered element has stand alone value to the
customer,
|
·
|
There
is objective evidence of the fair value of the remaining undelivered
elements, and
|
·
|
If
the arrangement contains a general right of return related to any products
delivered, delivery of the remaining goods and services is probable and
within the complete control of the
seller.
|
In the
case of the Senko Distribution Agreement, we determined that (a) the milestones
payments for achieving commercialization and (b) the future sale of Thin Film
products to Senko were “separable” elements. That is, each of these
elements, upon delivery, will have stand alone value to Senko and there will be
objective evidence of the fair value of any remaining undelivered elements at
that time. The arrangement does not contain any general right of
return, and so this point is not relevant to our analysis.
On the
other hand, we concluded that (a) the upfront distribution license fee, (b) the
revenues from training for representatives of Senko, and (c) the payments in the
form of royalties on future product sales are not separable elements under EITF
00-21.
40
In
arriving at our conclusions, we had to consider whether our customer, Senko,
would receive stand alone value from each delivered element. We also,
in some cases, had to look to third party evidence to support the fair value of
certain undelivered elements. Finally, we had to make assumptions
about how the non-separable elements of the arrangement are earned, particularly
the estimated period over which Senko will benefit from the arrangement (refer
to the “Recognition” discussion below for further background).
We also
agreed to perform elements under the November 4, 2005 agreements we signed with
Olympus, including:
·
|
Granting
the Joint Venture (which Olympus is considered to control) an exclusive
and perpetual manufacturing license to our device technology, including
the Celution™ System platform and certain related intellectual property;
and
|
·
|
Completing
certain pre-clinical and clinical studies, assisting with product
development and seeking regulatory approval and/or clearances toward
commercialization of the Celution™ System
platform.
|
We
concluded that the license and development services must be accounted for as a
single unit of accounting. In reaching this conclusion, we determined
that the license would not have stand alone value to the Joint
Venture. This is because Cytori is the only party that could be
reasonably expected to perform certain development contributions and
obligations, including product development assistance, certain agreed regulatory
filings and generally associated pre-clinical and clinical studies necessary for
the Joint Venture to derive value from the license.
Recognition
Besides
determining whether to account separately for components of a multiple-element
arrangement, we also use judgment in determining the appropriate accounting
period in which to recognize revenues that we believe (a) have been earned and
(b) are realizable. The following describes some of the recognition
issues we have considered during the reporting period.
·
|
Upfront
License Fees/Milestones
|
o
|
As
part of the Senko Distribution Agreement, we received an upfront license
fee upon execution of the arrangement, which, as noted previously, was not
separable under EITF 00-21. Accordingly, the license has been
combined with the development (milestones) element to form a single
accounting unit. This single element of $3,000,000 in fees
includes $1,500,000 which is potentially refundable. We have
recognized, and will continue to recognize, the non-contingent fees
allocated to this combined element as revenues as we complete each of the
performance obligations associated with the milestones component of this
combined deliverable. Note that the timing of when we have
recognized revenues to date does not correspond with the cash we received
upon achieving certain milestones. For example, the first such
milestone payment for $1,250,000 became payable to us when we filed a
commercialization application with the Japanese regulatory
authorities. However, we determined that the payment received
was not commensurate with the level of effort expended, particularly when
compared with other steps we believe are necessary to commercialize the
Thin Film product line in Japan. Accordingly, we did not
recognize the entire $1,250,000 received as revenues, but instead all but
$371,000 of this amount is classified as deferred
revenues. Approximately $371,000 ($10,000 in 2007, $152,000 in
2006, $51,000 in 2005 and $158,000 in 2004) has been recognized to date as
development revenues based on our estimates of the level of effort
expended for completed milestones as compared with the total level of
effort we expect to incur under the arrangement to successfully achieve
regulatory approval of the Thin Film product line in
Japan. These estimates were subject to judgment and there may
be changes to these estimates as we continue to seek regulatory
approval. In fact there can be no assurance that
commercialization in Japan will ever be achieved, as we have yet to
receive approval from the MHLW.
|
41
o
|
We
also received upfront fees as part of the Olympus arrangements (although,
unlike in the Senko agreement, these fees were
non-refundable). Specifically, in exchange for an upfront fee,
we granted the Joint Venture an exclusive, perpetual license to certain of
our intellectual property and agreed to perform additional development
activities. This upfront fee has been recorded in the liability
account entitled deferred revenues, related party, on our consolidated
balance sheet. Similar to the Senko agreement, we expect to
recognize revenues from the combined license/development accounting unit
as we perform our obligations under the agreements, as this represents our
final obligation underlying the combined accounting
unit. Specifically, we have recognized revenues from the
license/development accounting unit using a “proportional performance”
methodology, resulting in the de-recognition of amounts recorded in the
deferred revenues, related party, account as we complete various
milestones underlying the development services. Proportional
performance methodology was elected due to the nature of our development
obligations and efforts in support of the Joint Venture (“JV”), including
product development activities, and regulatory efforts to support the
commercialization of the JV products. The application of this methodology
uses the achievement of R&D milestones as outputs of value to the
JV. We received up-front, non-refundable payments in connection
with these development obligations, which we have broken down into
specific R&D milestones that are definable and substantive in nature,
and which will result in value to the JV when achieved. Revenue
will be recognized as the above mentioned R&D milestones are
completed. We established the R&D milestones based upon our
development obligations to the JV and the specific R&D support
activities to be performed to achieve these obligations. Our
R&D milestones consist of the following primary performance
categories: product development, regulatory approvals, and
generally associated pre-clinical and clinical
trials. Within each category are milestones that take
substantive effort to complete and are critical pieces of the overall
progress towards completion of the next generation product, which we are
obligated to support within the agreements entered into with
Olympus. To determine whether substantive effort was required
to achieve the milestones, we considered the external costs, required
personnel and relevant skill levels, the amount of time required to
complete each milestone, and the interdependent relationships between the
milestones, in that the benefits associated with the completion of one
milestone generally support and contribute to the achievement of the
next. Determination of the relative values assigned to each
milestone involved substantial judgment. The assignment process
was based on discussions with persons responsible for the development
process and the relative costs of completing each milestone. We
considered the costs of completing the milestones in allocating the
portion of the “deferred revenues, related party” account balance to each
milestone. Management believes that, while the costs incurred
in achieving the various milestones are subject to estimation, due to the
high correlation of such costs to outputs achieved, the use of external
contract research organization (“CRO”) costs and internal labor costs as
the basis for the allocation process provides management the ability to
accurately and reasonably estimate such costs. The accounting
policy described above could result in revenues being recorded in an
earlier accounting period than had other judgments or assumptions been
made by us.
|
·
|
Government
Grants
|
o
|
We
are eligible to receive grants from the NIH related to our research on
adipose derived cell therapy to treat myocardial
infarctions. Revenues derived from reimbursement of direct
out-of-pocket expenses for research costs associated with grants are
recorded in compliance with EITF Issue No. 99-19, “Reporting Revenue
Gross as a Principal Versus Net as an Agent”, and EITF Issue No.
01-14, “Income Statement Characterization of Reimbursements Received for
“Out-of-Pocket” Expenses Incurred”. In accordance with the criteria
established by these EITF Issues, the Company records grant revenue for
the gross amount of the reimbursement. The costs associated with
these reimbursements are reflected as a component of research and
development expense in the consolidated statements of
operations. Additionally, research arrangements we have with
NIH, as well commercial enterprises such as Olympus and Senko, are
considered a key component of our central and ongoing
operations. Moreover, the government obtains rights under the
arrangement, in the same manner (but perhaps not to the same extent) as a
commercial customer that similarly contracts with us to perform research
activities. For instance, the government and any authorized
third parties may use our federally funded research and/or inventions
without payment of royalties to us. Accordingly, the inflows
from such arrangements are presented as revenues in the consolidated
statements of operations.
|
Our
policy was to recognize revenues under the NIH grant arrangement as the lesser
of (i) qualifying costs incurred (and not previously recognized), plus our
allowable grant fees for which we are entitled to funding or (ii) the amount
determined by comparing the outputs generated to date versus the total outputs
expected to be achieved under the research arrangement.
42
Goodwill
Impairment Testing
In late
2002, we purchased StemSource, Inc. and recognized over $4,600,000 in goodwill
associated with the acquisition, of which $3,922,000 remains on our balance
sheet as of December 31, 2007. As required by Statement of Financial
Accounting Standard No. 142, “Goodwill and Other Intangible Assets” (“SFAS
142”), we must test this goodwill at least annually for impairment as well as
when an event occurs or circumstances change such that it is reasonably possible
that impairment may exist. Moreover, this testing must be performed
at a level of the organization known as the reporting unit. A
reporting unit is at least the same level as a company’s operating segments, and
sometimes even one level lower. Our two reporting units are, same as,
our two operating segments.
Specifically,
the process for testing goodwill for impairment under SFAS 142 involves the
following steps:
·
|
Company
assets and liabilities, including goodwill, are allocated to each
reporting unit for purposes of completing the goodwill impairment
test.
|
·
|
The
carrying value of each reporting unit – that is, the sum of all of the net
assets allocated to the reporting unit – is then compared to its fair
value.
|
·
|
If
the fair value of the reporting unit is lower than its carrying amount,
goodwill may be impaired – additional testing is
required.
|
The
application of the goodwill impairment test involves a substantial amount of
judgment. For instance, SFAS 142 requires that assets and liabilities
be assigned to a reporting unit if both of the following criteria are
met:
·
|
The
asset will be employed in or the liability relates to the operations of a
reporting unit.
|
·
|
The
asset or liability will be considered in determining the fair value of the
reporting unit.
|
We
developed mechanisms to assign company-wide assets like shared property and
equipment, as well as company-wide obligations such as borrowings under our GE
loan facility, to our two reporting units. In some cases, certain
assets were not allocable to either reporting unit and were left
unassigned.
We
estimated the fair value of our reporting units by using various estimation
techniques. For example in 2006, we estimated the fair value of our
MacroPore Biosurgery reporting unit based on an equal weighting of the market
values of comparable enterprises and discounted projections of estimated future
cash flows. Clearly, identifying comparable companies and estimating
future cash flows as well as appropriate discount rates involve
judgment. On the contrary, we estimated the fair value of our
regenerative cell reporting unit solely using an income approach, as – at that
time – we believed there were no comparable enterprises on which to base a
valuation. The assumptions underlying this valuation method involve a
substantial amount of judgment, particularly since our regenerative cell
business has yet to generate any revenues and does not have a commercially
viable product. The combined value of our goodwill is consistent with
the market’s valuation.
In 2007,
all goodwill that previously had been assigned to our MacroPore Biosurgery
reporting unit was derecognized as a result of our sale of our spine and
orthopedic product line to Kensey Nash. Accordingly, there was no
need to test this component of our business for goodwill impairment in
2007.
Also in
2007, we completed our goodwill impairment testing for our regenerative cell
technology reporting unit using a market-based approach. We concluded
that the fair value of this unit exceeded its carrying value, and that none of
our reported goodwill was impaired.
Again,
the manner in which we assigned assets, liabilities, and goodwill to our
reporting units, as well as how we determined the fair value of such reporting
units, involves significant uncertainties and estimates. The
judgments employed may have an effect on whether a goodwill impairment loss is
recognized.
43
Variable
Interest Entity (Olympus-Cytori Joint Venture)
FASB
Interpretation No. 46 (revised 2003), “Consolidation of Variable Interest
Entities - An Interpretation of ARB No. 51” (“FIN 46R”) requires a variable
interest entity (“VIE”) to be consolidated by its primary
beneficiary. Evaluating whether an entity is a VIE and determining
its primary beneficiary involves significant judgment.
We
concluded that the Olympus-Cytori Joint Venture was a VIE based on the following
factors:
·
|
Under
FIN 46R, an entity is a VIE if it has insufficient equity to finance its
activities. We recognized that the initial cash contributed to
the Joint Venture formed by Olympus and Cytori ($30,000,000) would be
completely utilized by the first quarter of 2006. Moreover, it
was highly unlikely that the Joint Venture would be able to obtain the
necessary financing from third party lenders without additional
subordinated financial support – such as personal guarantees by one or
both of the Joint Venture stockholders. Accordingly, the joint
venture will require additional financial support from Olympus and Cytori
to finance its ongoing operations, indicating that the Joint Venture is a
VIE. In fact, we contributed $300,000 and $150,000 in the
fourth quarter of 2007 and first quarter of 2006, respectively, to fund
the Joint Venture’s ongoing
operations.
|
·
|
Moreover,
Olympus has a contingent put option that would, in specified
circumstances, require Cytori to purchase Olympus’s interests in the Joint
Venture for a fixed amount of $22,000,000. Accordingly, Olympus
is protected in some circumstances from absorbing all expected losses in
the Joint Venture. Under FIN 46R, this means that Olympus may
not be an “at-risk” equity holder, although Olympus clearly has decision
rights over the operations of the Joint
Venture.
|
Because
the Joint Venture is undercapitalized, and because one of the Joint Venture’s
decision makers may be protected from losses, we have determined that the Joint
Venture is a VIE under FIN 46R.
As noted
previously, a VIE is consolidated by its primary beneficiary. The
primary beneficiary is defined in FIN 46R as the entity that would absorb the
majority of the VIE’s expected losses or be entitled to receive the majority of
the VIE’s residual returns (or both).
Significant
judgment was involved in determining the primary beneficiary of the Joint
Venture. Under FIN 46R, we believe that Olympus and Cytori are
“de facto agents” and, together, will absorb more than 50% of the Joint
Venture’s expected losses and residual returns. Ultimately, we
concluded that Olympus, and not Cytori, was the party most closely related with
the joint venture and, hence, its primary beneficiary. Our conclusion
was based on the following factors:
·
|
The
business operations of the Joint Venture will be most closely aligned to
those of Olympus (i.e., the manufacture of
devices).
|
·
|
Olympus
controls the Board of Directors, as well as the day-to-day operations of
the Joint Venture.
|
The
application of FIN 46R involves substantial judgment. Had we
consolidated the Joint Venture, though, there would be no effect on our net loss
or shareholders’ equity at December 31, 2007 or for the year then
ended. However, certain balance sheet and income statement captions
would have been presented in a different manner. For instance, we
would not have presented a single line item entitled investment in joint venture
in our balance sheet but, instead, would have performed a line by line
consolidation of each of the Joint Venture’s accounts into our financial
statements.
Net
Operating Loss and Tax Credit Carryforwards
We have
established a valuation allowance against our net deferred tax assets due to the
uncertainty surrounding the realization of such assets. We periodically evaluate
the recoverability of the deferred tax assets. At such time as it is determined
that it is more likely than not that deferred assets are realizable, the
valuation allowance will be reduced. We have recorded a valuation allowance of
$50,435,000 as of December 31, 2007 to reflect the estimated amount of deferred
tax assets that may not be realized. We increased our valuation allowance by
approximately $11,930,000 during the year ended December 31, 2007. The valuation
allowance includes approximately $579,000 related to stock option deductions,
the benefit of which, if realized, will eventually be credited to equity and not
to income.
44
At
December 31, 2007, we had federal and state tax loss carryforwards of
approximately $89,941,000 and $77,254,000 respectively. The federal
and state net operating loss carryforwards begin to expire in 2019 and 2013
respectively, if unused. At December 31, 2007, we had federal and
state tax credit carryforwards of approximately $2,946,000 and $2,735,000
respectively. The federal credits will begin to expire in 2017, if
unused, and $160,000 of the state credits will begin to expire in 2009 if
unused. The remaining state credits carry forward
indefinitely. In addition, we had a foreign tax loss carryforward of
$2,774,000 and $179,000 in Japan and the United Kingdom,
respectively.
The
Internal Revenue Code limits the future availability of net operating loss and
tax credit carryforwards that arose prior to certain cumulative changes in a
corporation’s ownership resulting in a change of control of Cytori. Due to prior
ownership changes as defined in IRC Section 382, a portion of our net operating
loss and tax credit carryforwards are limited in their annual
utilization. In September 1999, we experienced an ownership change
for purposes of the IRC Section 382 limitation. As of December 31,
2007, these pre-change net operating losses and credits are fully
available.
Additionally,
in 2002 when we purchased StemSource, we acquired federal and state net
operating loss carryforwards of approximately $2,700,000 and $2,700,000
respectively. This event triggered an ownership change for purposes
of IRC Section 382. It is estimated that the pre-change net operating
losses and credits will be fully available by 2008.
We have
completed an update to our IRC Section 382 study analysis through April 17,
2007. We have not had any additional ownership changes based on this
study.
Recent
Accounting Pronouncements
In June
2006, the Financial Accounting Standards Board (“FASB”) issued Interpretation
No. 48, “Accounting for Uncertainty in Income Taxes, interpretation of FASB
Statement No. 109” (“FIN 48”). It prescribes a recognition threshold
and measurement attribute for the financial statement recognition and
measurement of a tax position taken or expected to be taken in a tax
return. FIN 48 also provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods,
disclosure and transition. We adopted this interpretation effective
January 1, 2007. The adoption of FIN 48 did not have a significant
effect on our consolidated financial statements.
In
September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements” (“SFAS
157”). SFAS 157 defines fair value, establishes a framework for measuring fair
value and expands disclosure of fair value measurements. SFAS 157 applies under
other accounting pronouncements that require or permit fair value measurements
and accordingly, does not require any new fair value measurements. SFAS 157 was
initially effective for financial statements issued for fiscal years beginning
after November 15, 2007. In February 2008, the FASB issued staff position
FAS 157-2, which delays the effective date of SFAS 157 for certain nonfinancial
assets and liabilities for fiscal years beginning after November 15, 2008.
We do not believe that the adoption of SFAS 157 will have a significant effect
on our consolidated financial statements.
In March
2007, the FASB ratified the consensus reached by the Emerging Issues Task Force
on Issue No. 07-3, “Accounting for Nonrefundable Advance Payments for Goods or
Services to Be Used in Future Research and Development Activities” (“EITF
07-3”). EITF 07-3 states that nonrefundable advance payments for
future research and development activities should be deferred and
capitalized. Such amounts should be recognized as an expense as the
goods are delivered or the related services are performed. The
guidance is effective for all periods beginning after December 15, 2007. We are
currently in the process of evaluating whether the adoption of EITF 07-3 will
have a significant effect on our consolidated financial
statements.
In
February 2007, the FASB issued SFAS 159, “The Fair Value Option for Financial
Assets and Financial Liabilities- Including an amendment of FASB Statement
No. 115” (“SFAS 159”), which permits entities to choose to measure many
financial instruments and certain other items at fair value. The provisions of
SFAS 159 are effective for financial statements issued for fiscal years
beginning after November 15, 2007. We do not believe that the
adoption of SFAS 159 will have a significant effect on our consolidated
financial statements.
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling Interests in
Consolidated Financial Statements - An Amendment of ARB No. 51” ("SFAS
160"). SFAS 160 establishes new accounting and reporting standards
for the noncontrolling interest in a subsidiary and for the deconsolidation of a
subsidiary. SFAS 160 is effective for annual periods beginning on or after
December 15, 2008. We do not believe that the adoption of SFAS 160
will have a significant effect on our consolidated financial
statements.
45
In
December 2007, the FASB issued SFAS No. 141 (revised 2007), “Business
Combinations” ("SFAS 141R"). SFAS 141R retains the fundamental
requirements of Statement No. 141 to account for all business combinations using
the acquisition method (formerly the purchase method) and for an acquiring
entity to be identified in all business combinations. However, the
new standard requires the acquiring entity in a business combination to
recognize all the assets acquired and liabilities assumed in the transaction;
establishes the acquisition-date fair value as the measurement objective for all
assets acquired and liabilities assumed; and requires the acquirer to disclose
the information they need to evaluate and understand the nature and financial
effect of the business combination. SFAS 141R is effective for
acquisitions made on or after the first day of annual periods beginning on or
after December 15, 2008. We do not believe that the adoption of SFAS
141R will have a significant effect on our consolidated financial
statements.
In
December 2007, the FASB ratified the consensus reached by the Emerging Issues
Task Force (EITF) on EITF Issue 07-1, “Accounting for Collaborative
Arrangements” (“EITF 07-1”). EITF 07-1 requires collaborators to
present the results of activities for which they act as the principal on a gross
basis and report any payments received from (made to) other collaborators based
on other applicable GAAP or, in the absence of other applicable GAAP, based on
analogy to authoritative accounting literature or a reasonable, rational, and
consistently applied accounting policy election. The guidance is
effective for fiscal years beginning after December 15, 2008. We are
currently in the process evaluating whether the adoption of EITF 07-1 will have
a significant effect on our consolidated financial statements.
Item 7A. Quantitative and Qualitative Disclosures About Market
Risk
We are
exposed to market risk related to fluctuations in interest rates and in foreign
currency exchange rates.
Interest
Rate Exposure
We are
not subject to market risk due to fluctuations in interest rates on our
long-term obligations as they bear a fixed rate of interest. Our
exposure relates primarily to short-term investments, including funds classified
as cash equivalents. Investment securities are subject to market rate
risk as their fair value will fall if market interest rates
increase. If market interest rates were to increase immediately and
uniformly by 100 basis points from the levels prevailing at December 31, 2007,
for example, and assuming average investment duration of seven months, the fair
value of the portfolio would not decline by a material amount. We do
not use derivative financial instruments to mitigate the risk inherent in these
securities. However, we do attempt to reduce such risks by generally
limiting the maturity date of such securities, diversifying our investments and
limiting the amount of credit exposure with any one issuer. While we
do not always have the intent, we do currently have the ability to hold these
investments until maturity and, therefore, believe that reductions in the value
of such securities attributable to short-term fluctuations in interest rates
would not materially affect our financial position, results of operations or
cash flows. Changes in interest rates would, of course, affect the
interest income we earn on our cash balances after re-investment.
Foreign
Currency Exchange Rate Exposure
Our
exposure to market risk due to fluctuations in foreign currency exchange rates
relates primarily to our activities in Europe and Japan. Transaction
gains or losses resulting from cash balances and revenues have not been
significant in the past and we are not engaged in any hedging activity in the
Euro, the Yen or other currencies. Based on our cash balances and
revenues derived from markets other than the United States for the year ended
December 31, 2007, a hypothetical 10% adverse change in the Euro or Yen against
the U.S. dollar would not result in a material foreign currency exchange
loss. Consequently, we do not expect that reductions in the value of
such sales denominated in foreign currencies resulting from even a sudden or
significant fluctuation in foreign exchange rates would have a direct material
impact on our financial position, results of operations or cash
flows.
Notwithstanding
the foregoing, the indirect effect of fluctuations in interest rates and foreign
currency exchange rates could have a material adverse effect on our business,
financial condition and results of operations. For example, foreign
currency exchange rate fluctuations may affect international demand for our
products. In addition, interest rate fluctuations may affect our
customers’ buying patterns. Furthermore, interest rate and currency
exchange rate fluctuations may broadly influence the United States and foreign
economies resulting in a material adverse effect on our business, financial
condition and results of operations.
Under our
Japanese Thin Film agreement with Senko, we would receive payments in the nature
of royalties based on Senko’s net sales, which would be Yen
denominated.
46
Item 8. Financial Statements and Supplementary
Data
|
|
|
|
|
|
|
|
|
|
|
|
|
47
PART
I. FINANCIAL INFORMATION
|
||||||||||||||||
Item
1. Financial Statements
|
||||||||||||||||
Report of
Independent Registered Public Accounting Firm
The Board
of Directors and Stockholders
Cytori
Therapeutics, Inc.:
We have
audited the accompanying consolidated balance sheets of Cytori Therapeutics,
Inc. and subsidiaries (the Company) as of December 31, 2007 and 2006, and
the related consolidated statements of operations and comprehensive loss,
stockholders’ equity (deficit), and cash flows for each of the years in the
three-year period ended December 31, 2007. In connection with our audits of
the consolidated financial statements, we have also audited the accompanying
schedule of valuation and qualifying accounts. These consolidated financial
statements and financial statement schedule are the responsibility of the
Company’s management. Our responsibility is to express an opinion on these
consolidated financial statements 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 consolidated financial statements referred to above present fairly,
in all material respects, the financial position of Cytori Therapeutics, Inc.
and subsidiaries as of December 31, 2007 and 2006, and the results of their
operations and their cash flows for each of the years in the three-year period
ended December 31, 2007, 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 consolidated 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), Cytori Therapeutics, Inc.’s internal control
over financial reporting as of December 31, 2007, based on criteria
established in Internal
Control – Integrated Framework issued by the Committee of Sponsoring
Organizations of the Treadway Commission (COSO), and our report dated
March 13, 2008, expressed an unqualified opinion on the effectiveness of
the Company’s internal control over financial reporting.
/s/
KPMG LLP
|
|
San
Diego, California
|
|
March
13, 2008
|
48
Report of Independent Registered
Public Accounting Firm
The Board
of Directors and Stockholders
Cytori
Therapeutics, Inc.:
We have
audited Cytori Therapeutics, Inc.’s internal control over financial reporting as
of December 31, 2007, based on criteria established in Internal Control — Integrated
Framework issued by the Committee of Sponsoring Organizations of the
Treadway Commission (COSO).
Cytori Therapeutics, Inc.'s 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 Report on Internal Control Over Financial Reporting
(Item 9A). 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, and
testing and evaluating the design and operating effectiveness of internal
control based on the assessed risk. Our audit also included 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 U.S. 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 U.S. 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, Cytori Therapeutics, Inc. maintained, in all material respects,
effective internal control over financial reporting as of December 31, 2007,
based on criteria established in Internal Control — Integrated Framework issued
by the Committee of Sponsoring Organizations of the Treadway Commission
(COSO).
We also
have audited, in accordance with the standards of the Public Company Accounting
Oversight Board (United States), the consolidated balance sheets of Cytori
Therapeutics, Inc. as of December 31, 2007 and 2006, and the related
consolidated statements of operations and comprehensive loss, stockholders’
equity (deficit), and cash flows for each of the years in the three-year period
ended December 31, 2007, and our report dated March 13, 2008, expressed an
unqualified opinion on those consolidated financial statements.
/s/
KPMG LLP
|
|
San
Diego, California
|
|
March
13, 2008
|
49
CYTORI THERAPEUTICS, INC.
CONSOLIDATED
BALANCE SHEETS
As of December 31,
|
||||||||
2007
|
2006
|
|||||||
Assets
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 11,465,000 | $ | 8,902,000 | ||||
Short-term
investments, available-for-sale
|
— | 3,976,000 | ||||||
Accounts
receivable, net of allowance for doubtful accounts of $1,000 and $2,000 in
2007 and 2006, respectively
|
9,000 | 225,000 | ||||||
Inventories,
net
|
— | 164,000 | ||||||
Other
current assets
|
764,000 | 711,000 | ||||||
Total
current assets
|
12,238,000 | 13,978,000 | ||||||
Property
and equipment held for sale, net
|
— | 457,000 | ||||||
Property
and equipment, net
|
3,432,000 | 4,242,000 | ||||||
Investment
in joint venture
|
369,000 | 76,000 | ||||||
Other
assets
|
468,000 | 428,000 | ||||||
Intangibles,
net
|
1,078,000 | 1,300,000 | ||||||
Goodwill
|
3,922,000 | 4,387,000 | ||||||
Total
assets
|
$ | 21,507,000 | $ | 24,868,000 | ||||
Liabilities
and Stockholders’ Deficit
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable and accrued expenses
|
$ | 7,349,000 | $ | 5,587,000 | ||||
Current
portion of long-term obligations
|
721,000 | 999,000 | ||||||
Total
current liabilities
|
8,070,000 | 6,586,000 | ||||||
Deferred
revenues, related party
|
18,748,000 | 23,906,000 | ||||||
Deferred
revenues
|
2,379,000 | 2,389,000 | ||||||
Option
liability
|
1,000,000 | 900,000 | ||||||
Long-term
deferred rent
|
473,000 | 741,000 | ||||||
Long-term
obligations, less current portion
|
237,000 | 1,159,000 | ||||||
Total
liabilities
|
30,907,000 | 35,681,000 | ||||||
Commitments
and contingencies
|
||||||||
Stockholders’
deficit:
|
||||||||
Preferred
stock, $0.001 par value; 5,000,000 shares authorized; -0- shares issued
and outstanding in 2007 and 2006
|
— | — | ||||||
Common
stock, $0.001 par value; 95,000,000 shares authorized; 25,962,222 and
21,612,243 shares issued and 24,089,388 and 18,739,409 shares outstanding
in 2007 and 2006, respectively
|
26,000 | 22,000 | ||||||
Additional
paid-in capital
|
129,504,000 | 103,053,000 | ||||||
Accumulated
deficit
|
(132,132,000 | ) | (103,460,000 | ) | ||||
Treasury
stock, at cost
|
(6,794,000 | ) | (10,414,000 | ) | ||||
Accumulated
other comprehensive income
|
— | 1,000 | ||||||
Amount
due from exercises of stock
options
|
(4,000 | ) | (15,000 | ) | ||||
Total
stockholders’ deficit
|
(9,400,000 | ) | (10,813,000 | ) | ||||
Total
liabilities and stockholders’ deficit
|
$ | 21,507,000 | $ | 24,868,000 |
THE
ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THESE CONSOLIDATED FINANCIAL
STATEMENTS
50
CYTORI THERAPEUTICS, INC.
CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
For the Years Ended December 31,
|
||||||||||||
2007
|
2006
|
2005
|
||||||||||
Product
revenues, related party
|
$ | 792,000 | $ | 1,451,000 | $ | 5,634,000 | ||||||
Cost
of product revenues
|
422,000 | 1,634,000 | 3,154,000 | |||||||||
Gross
profit (loss)
|
370,000 | (183,000 | ) | 2,480,000 | ||||||||
Development
revenues:
|
||||||||||||
Development,
related party
|
5,158,000 | 5,905,000 | — | |||||||||
Development
|
10,000 | 152,000 | 51,000 | |||||||||
Research
grants and other
|
89,000 | 419,000 | 320,000 | |||||||||
5,257,000 | 6,476,000 | 371,000 | ||||||||||
Operating
expenses:
|
||||||||||||
Research
and development
|
20,020,000 | 21,977,000 | 15,450,000 | |||||||||
Sales
and marketing
|
2,673,000 | 2,055,000 | 1,547,000 | |||||||||
General
and administrative
|
14,184,000 | 12,547,000 | 10,208,000 | |||||||||
Change
in fair value of option liabilities
|
100,000 | (4,431,000 | ) | 3,645,000 | ||||||||
Total
operating expenses
|
36,977,000 | 32,148,000 | 30,850,000 | |||||||||
Operating
loss
|
(31,350,000 | ) | (25,855,000 | ) | (27,999,000 | ) | ||||||
Other
income (expense):
|
||||||||||||
Gain
on sale of assets
|
1,858,000 | — | 5,526,000 | |||||||||
Interest
income
|
1,028,000 | 708,000 | 299,000 | |||||||||
Interest
expense
|
(155,000 | ) | (199,000 | ) | (137,000 | ) | ||||||
Other
expense, net
|
(46,000 | ) | (27,000 | ) | (55,000 | ) | ||||||
Equity
loss from investment in joint venture
|
(7,000 | ) | (74,000 | ) | (4,172,000 | ) | ||||||
Total
other income
|
2,678,000 | 408,000 | 1,461,000 | |||||||||
Net
loss
|
(28,672,000 | ) | (25,447,000 | ) | (26,538,000 | ) | ||||||
Other
comprehensive income (loss) - unrealized holding income
(loss)
|
(1,000 | ) | 17,000 | 16,000 | ||||||||
Comprehensive
loss
|
$ | (28,673,000 | ) | $ | (25,430,000 | ) | $ | (26,522,000 | ) | |||
Basic
and diluted net loss per common share
|
$ | (1.25 | ) | $ | (1.53 | ) | $ | (1.80 | ) | |||
Basic
and diluted weighted average common shares
|
22,889,250 | 16,603,550 | 14,704,281 |
THE
ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THESE CONSOLIDATED FINANCIAL
STATEMENTS
51
CYTORI THERAPEUTICS, INC.
CONSOLIDATED
STATEMENTS OF STOCKHOLDERS’ EQUITY (DEFICIT)
FOR
THE YEARS ENDED DECEMBER 31, 2007, 2006 AND 2005
Accumulated
|
Amount
due
|
|||||||||||||||||||||||||||||||||||
Additional
|
Other
|
From
|
||||||||||||||||||||||||||||||||||
Common
Stock
|
Paid-in
|
Accumulated
|
Treasury
Stock
|
Comprehensive
|
Exercises
of
|
|||||||||||||||||||||||||||||||
Shares
|
Amount
|
Capital
|
Deficit
|
Shares
|
Amount
|
Income
(Loss)
|
Stock
Options
|
Total
|
||||||||||||||||||||||||||||
Balance
at December 31, 2004
|
16,820,018 | $ | 17,000 | $ | 74,737,000 | $ | (51,475,000 | ) | 2,872,834 | $ | (10,414,000 | ) | $ | (32,000 | ) | $ | — | $ | 12,833,000 | |||||||||||||||||
Issuance
of common stock under stock option plan
|
232,042 | — | 174,000 | — | — | — | — | — | 174,000 | |||||||||||||||||||||||||||
Issuance
of common stock under stock warrant agreement
|
22,223 | — | 50,000 | — | — | — | — | — | 50,000 | |||||||||||||||||||||||||||
Compensatory
stock options
|
— | — | 341,000 | — | — | — | — | — | 341,000 | |||||||||||||||||||||||||||
Compensatory
common stock awards
|
20,000 | — | 63,000 | — | — | — | — | — | 63,000 | |||||||||||||||||||||||||||
Issuance
of common stock to Olympus
|
1,100,000 | 1,000 | 3,002,000 | — | — | — | — | — | 3,003,000 | |||||||||||||||||||||||||||
Accretion
of interests in joint venture
|
— | — | 3,829,000 | — | — | — | — | — | 3,829,000 | |||||||||||||||||||||||||||
Unrealized
gain on investments
|
— | — | — | — | — | — | 16,000 | — | 16,000 | |||||||||||||||||||||||||||
Net
loss for the year ended December 31, 2005
|
— | — | — | (26,538,000 | ) | — | — | — | — | (26,538,000 | ) | |||||||||||||||||||||||||
Balance
at December 31, 2005
|
18,194,283 | 18,000 | 82,196,000 | (78,013,000 | ) | 2,872,834 | (10,414,000 | ) | (16,000 | ) | — | (6,229,000 | ) | |||||||||||||||||||||||
Stock-based
compensation expense
|
— | — | 3,202,000 | — | — | — | — | — | 3,202,000 | |||||||||||||||||||||||||||
Issuance
of common stock under stock option plan
|
397,205 | 1,000 | 934,000 | — | — | — | — | — | 935,000 | |||||||||||||||||||||||||||
Compensatory
common stock awards
|
2,500 | — | 18,000 | — | — | — | — | — | 18,000 | |||||||||||||||||||||||||||
Sale
of common stock
|
2,918,255 | 3,000 | 16,216,000 | — | — | — | — | — | 16,219,000 | |||||||||||||||||||||||||||
Stock
issued for license amendment
|
100,000 | — | 487,000 | — | — | — | — | — | 487,000 | |||||||||||||||||||||||||||
Amount
due from exercises of stock options
|
— | — | — | — | — | — | — | (15,000 | ) | (15,000 | ) | |||||||||||||||||||||||||
Unrealized
gain on investments
|
— | — | — | — | — | — | 17,000 | — | 17,000 | |||||||||||||||||||||||||||
Net
loss for the year ended December 31, 2006
|
— | — | — | (25,447,000 | ) | — | — | — | — | (25,447,000 | ) | |||||||||||||||||||||||||
Balance
at December 31, 2006
|
21,612,243 | 22,000 | 103,053,000 | (103,460,000 | ) | 2,872,834 | (10,414,000 | ) | 1,000 | (15,000 | ) | (10,813,000 | ) | |||||||||||||||||||||||
Stock-based
compensation expense
|
— | — | 2,310,000 | — | — | — | — | — | 2,310,000 | |||||||||||||||||||||||||||
Issuance
of common stock under stock option plan
|
604,334 | 1,000 | 1,863,000 | — | — | — | — | — | 1,864,000 | |||||||||||||||||||||||||||
Sale
of common stock
|
3,745,645 | 3,000 | 19,898,000 | — | — | — | — | — | 19,901,000 | |||||||||||||||||||||||||||
Sale
of treasury stock
|
— | — | 2,380,000 | — | (1,000,000 | ) | 3,620,000 | — | — | 6,000,000 | ||||||||||||||||||||||||||
Amount
due from exercises of stock options
|
— | — | — | — | — | — | — | 11,000 | 11,000 | |||||||||||||||||||||||||||
Unrealized
loss on investments
|
— | — | — | — | — | — | (1,000 | ) | — | (1,000 | ) | |||||||||||||||||||||||||
Net
loss for the year ended December 31, 2007
|
— | — | — | (28,672,000 | ) | — | — | — | — | (28,672,000 | ) | |||||||||||||||||||||||||
Balance
at December 31, 2007
|
25,962,222 | $ | 26,000 | $ | 129,504,000 | $ | (132,132,000 | ) | 1,872,834 | $ | (6,794,000 | ) | $ | — | $ | (4,000 | ) | $ | (9,400,000 | ) |
THE
ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THESE CONSOLIDATED FINANCIAL
STATEMENT
52
CYTORI THERAPEUTICS, INC.
CONSOLIDATED
STATEMENTS OF CASH FLOWS
For the Years Ended December 31,
|
||||||||||||
2007
|
2006
|
2005
|
||||||||||
Cash
flows from operating activities:
|
||||||||||||
Net
loss
|
$ | (28,672,000 | ) | $ | (25,447,000 | ) | $ | (26,538,000 | ) | |||
Adjustments
to reconcile net loss to net cash used in operating
activities:
|
||||||||||||
Depreciation
and amortization
|
1,616,000 | 2,120,000 | 1,724,000 | |||||||||
Inventory
provision
|
70,000 | 88,000 | 280,000 | |||||||||
Warranty
provision (reversal)
|
(65,000 | ) | (23,000 | ) | 53,000 | |||||||
(Reduction)
increase in allowance for doubtful accounts
|
(1,000 | ) | (7,000 | ) | 1,000 | |||||||
Change
in fair value of option liabilities
|
100,000 | (4,431,000 | ) | 3,645,000 | ||||||||
Gain
on sale of assets
|
(1,858,000 | ) | — | (5,526,000 | ) | |||||||
Stock-based
compensation
|
2,310,000 | 3,220,000 | 404,000 | |||||||||
Stock
issued for license amendment
|
— | 487,000 | — | |||||||||
Equity
loss from investment in joint venture
|
7,000 | 74,000 | 4,172,000 | |||||||||
Increases
(decreases) in cash caused by changes in operating assets and
liabilities:
|
||||||||||||
Accounts
receivable
|
217,000 | 598,000 | 46,000 | |||||||||
Inventories
|
— | 6,000 | (159,000 | ) | ||||||||
Other
current assets
|
(70,000 | ) | (90,000 | ) | 363,000 | |||||||
Other
assets
|
(40,000 | ) | 30,000 | (346,000 | ) | |||||||
Accounts
payable and accrued expenses
|
1,827,000 | 281,000 | 3,027,000 | |||||||||
Deferred
revenues, related party
|
(5,158,000 | ) | 6,595,000 | 17,311,000 | ||||||||
Deferred
revenues
|
(10,000 | ) | (152,000 | ) | (51,000 | ) | ||||||
Long-term
deferred rent
|
(268,000 | ) | 168,000 | 493,000 | ||||||||
Net
cash used in operating activities
|
(29,995,000 | ) | (16,483,000 | ) | (1,101,000 | ) | ||||||
Cash
flows from investing activities:
|
||||||||||||
Proceeds
from the sale and maturity of short-term investments
|
28,007,000 | 67,137,000 | 56,819,000 | |||||||||
Purchases
of short-term investments
|
(24,032,000 | ) | (63,258,000 | ) | (54,062,000 | ) | ||||||
Proceeds
from the sale of assets
|
3,175,000 | — | — | |||||||||
Costs
from sale of assets
|
(305,000 | ) | — | — | ||||||||
Purchases
of property and equipment
|
(563,000 | ) | (3,138,000 | ) | (1,846,000 | ) | ||||||
Investment
in joint venture
|
(300,000 | ) | (150,000 | ) | — | |||||||
Net
cash provided by investing activities
|
5,982,000 | 591,000 | 911,000 | |||||||||
Cash
flows from financing activities:
|
||||||||||||
Principal
payments on long-term obligations
|
(1,200,000 | ) | (952,000 | ) | (936,000 | ) | ||||||
Proceeds
from long-term obligations
|
— | 600,000 | 1,380,000 | |||||||||
Proceeds
from exercise of employee stock options and warrants
|
1,875,000 | 920,000 | 224,000 | |||||||||
Proceeds
from sale of common stock
|
21,500,000 | 16,780,000 | 3,003,000 | |||||||||
Costs
from sale of common stock
|
(1,599,000 | ) | (561,000 | ) | — | |||||||
Proceeds
from issuance of options, related party
|
— | — | 1,686,000 | |||||||||
Proceeds
from sale of treasury stock
|
6,000,000 | — | — | |||||||||
Net
cash provided by financing activities
|
26,576,000 | 16,787,000 | 5,357,000 | |||||||||
Net
increase in cash and cash equivalents
|
2,563,000 | 895,000 | 5,167,000 | |||||||||
Cash
and cash equivalents at beginning of year
|
8,902,000 | 8,007,000 | 2,840,000 | |||||||||
Cash
and cash equivalents at end of year
|
$ | 11,465,000 | $ | 8,902,000 | $ | 8,007,000 |
53
For the Years Ended December 31,
|
||||||||||||
2007
|
2006
|
2005
|
||||||||||
Supplemental
disclosure of cash flows information:
|
||||||||||||
Cash
paid during period for:
|
||||||||||||
Interest
|
$ | 160,000 | $ | 201,000 | $ | 135,000 | ||||||
Taxes
|
2,000 | 1,000 | 13,000 | |||||||||
Supplemental
schedule of non-cash investing and financing activities:
|
||||||||||||
Transfer
of intangible assets to joint venture (note 4)
|
$ | — | $ | — | $ | 343,000 | ||||||
Accretion
of interest in joint venture (note 4)
|
— | — | 3,829,000 | |||||||||
Additions
to leasehold improvements included in accounts payable and accrued
expenses
|
— | — | 800,000 | |||||||||
Amount
due from exercise of stock options
|
4,000 | 15,000 | — |
THE
ACCOMPANYING NOTES ARE AN INTEGRAL PART OF THESE CONSOLIDATED FINANCIAL
STATEMENTS
54
CYTORI THERAPEUTICS, INC.
NOTES
TO CONSOLIDATED FINANCIAL STATEMENTS
DECEMBER
31, 2007
1.
|
Organization
and Operations
|
The
Company
Cytori
Therapeutics, Inc., develops, manufactures and sells medical technologies to
enable the practice of regenerative medicine. Our commercial activities are
currently focused on reconstructive surgery in Europe and stem cell banking
(cell preservation) in Japan and we are seeking to bring our products to market
in the United States as well as other countries. Our product pipeline is
developing potential new treatments for cardiovascular disease, orthopedic
damage, gastrointestinal disorders, and pelvic health.
Our Thin
Film product line will be marketed exclusively in Japan by Senko Medical Trading
Co. (“Senko”) following regulatory approval of the product in
Japan.
We have a
subsidiary located in Japan.
Principles
of Consolidation
The
consolidated financial statements include our accounts and those of our
subsidiaries. All significant intercompany transactions and balances
have been eliminated. Management evaluates its investments on an
individual basis for purposes of determining whether or not consolidation is
appropriate. In instances where we do not demonstrate control through
decision-making ability and/or a greater than 50% ownership interest, we account
for the related investments under the cost or equity method, depending upon
management’s evaluation of our ability to exercise and retain significant
influence over the investee. Our investment in the Olympus-Cytori, Inc. joint
venture has been accounted for under the equity method of accounting (see note 4
for further details).
Certain
Risks and Uncertainties
We have a
limited operating history and our prospects are subject to the risks and
uncertainties frequently encountered by companies in the early stages of
development and commercialization, especially those companies in rapidly
evolving and technologically advanced industries such as the biotech/medical
device field. Our future viability largely depends on our ability to complete
development of new products and receive regulatory approvals for those products.
No assurance can be given that our new products will be successfully developed,
regulatory approvals will be granted, or acceptance of these products will be
achieved. The development of medical devices for specific therapeutic
applications is subject to a number of risks, including research, regulatory and
marketing risks. There can be no assurance that our development stage products
will overcome these hurdles and become commercially viable and/or gain
commercial acceptance.
For the
years ended December 31, 2007, 2006 and 2005, we recorded bioresorbable product
revenue from Medtronic of $792,000, $1,451,000 and $5,634,000, respectively,
which represented 13.1%, 18.3% and 93.8% of total product and development
revenues, respectively. We sold our bioresorbable spine and
orthopedic surgical implant product line to Kensey Nash in May
2007.
Capital
Availability
We have a
limited operating history and recorded the first sale of our products in 1999.
We incurred losses of $28,672,000, $25,447,000 and $26,538,000 for the
years ended December 31, 2007, 2006 and 2005, respectively, and have an
accumulated deficit of $132,132,000 as of December 31, 2007. Additionally, we
have used net cash of $29,995,000, $16,483,000 and $1,101,000 to fund our
operating activities for the years ended December 31, 2007, 2006 and 2005,
respectively.
Management
recognizes the need to generate positive cash flows in future periods and/or to
obtain additional capital from various sources. In the continued absence of
positive cash flows from operations, no assurance can be given that we can
generate sufficient revenue to cover operating costs or that additional
financing will be available to us and, if available, on terms acceptable to us
in the future. See note 19 for discussion of financing arrangements
made subsequent to December 31, 2007.
The
Company expects to utilize its cash and cash equivalents to fund its operations,
including research and development of its products primarily for development and
pre-clinical activities and for clinical trials. Additionally, the Company
believes that without additional capital from operations and other accessible
sources of financing it does not currently have adequate funding to complete the
development, preclinical activities and clinical trials required to bring its
future products to market, therefore, it will require significant additional
funding. If the Company is unsuccessful in its efforts to raise additional
funds through accessible sources of financing, strategic relationships or
through revenue sources, it will be required to significantly reduce or curtail
its research and development activities and other operations. Management
actively monitors cash expenditures and projected expenditures as we progress
toward our goals of product commercialization and sales in an effort to match
projected expenditures to available cash flow.
55
2.
|
Summary
of Significant Accounting Policies
|
Use
of Estimates
The
preparation of consolidated financial statements in conformity with accounting
principles generally accepted in the United States requires management to make
estimates and assumptions affecting 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 revenue and expenses
during the reporting period. Actual results could differ from these estimates.
Estimates and assumptions are reviewed periodically, and the effects of
revisions are reflected in the consolidated financial statements in the periods
they are determined to be necessary.
Our most
significant estimates and critical accounting policies involve revenue
recognition, evaluating goodwill for impairment, accounting for product line
dispositions, valuing our put option arrangement with Olympus Corporation (Put
option) (see note 4), determining assumptions used in measuring share-based
compensation expense, valuing our deferred tax assets, and assessing how to
report our investment in Olympus-Cytori, Inc.
Presentation
Certain
prior period amounts have been reclassified to conform to current period
presentation.
Cash
and Cash Equivalents
We
consider all highly liquid investments with maturities of three months or less
at the time of purchase to be cash equivalents. Investments with original
maturities of three months or less that were included with and classified as
cash and cash equivalents totaled $10,502,000 and $7,500,000 as of December 31,
2007 and 2006, respectively.
Short-term
Investments
We invest
excess cash in money market funds, highly liquid debt instruments of financial
institutions and corporations with strong credit ratings, and in United States
government obligations. We have established guidelines relative to
diversification and maturities that maintain safety and liquidity. These
guidelines are periodically reviewed and modified to take advantage of trends in
yields and interest rates.
We
evaluate our investments in accordance with the provisions of Statement of
Financial Standards (“SFAS”) No. 115, “Accounting for Certain Investments in
Debt and Equity Securities.” Based on our intent, our investment
policies and our ability to liquidate debt securities, we classify short-term
investment securities within current assets. Available-for-sale securities are
carried at fair value, with unrealized gains and losses reported as accumulated
other comprehensive income (loss) within stockholders’ equity. The amortized
cost basis of debt securities is periodically adjusted for amortization of
premiums and accretion of discounts to maturity. Such amortization is included
as a component of interest income or interest expense. The amortized cost basis
of securities sold is based on the specific identification method and all such
realized gains and losses are recorded as a component within other income
(expense). We review the carrying values of our investments and write
down such investments to estimated fair value by a charge to the statements of
operations when the severity and duration of a decline in the value of an
investment is considered to be other than temporary. The cost of
securities sold or purchased is recorded on the settlement date.
After
considering current market conditions, and in order to minimize our risk,
management has elected to invest all excess funds in money market funds and
other highly liquid investments that are appropriately classified as cash
equivalents as of December 31, 2007.
Fair
Value of Financial Instruments
The
carrying amounts of our cash and cash equivalents, accounts receivable, accounts
payable and accrued expenses approximate their fair value due to the short-term
nature of these balances. The carrying amounts of our current portion
of long-term obligations and long-term obligations approximate fair value as the
terms and rates of interest for these instruments approximate terms and market
rates of interest currently available to us for similar instruments. Our option
liability is already reported at its fair value based on established option
pricing theory and assumptions (note 4). Short-term investments are
also reported at fair value in the financial statements.
56
Inventories
Inventories
include the cost of material, labor and overhead, and are stated at the lower of
average cost, determined on the first-in, first-out (FIFO) method, or
market. We periodically evaluate our on-hand stock and make
appropriate provisions for any stock deemed as excess or obsolete. We
expense excess manufacturing costs: that is, costs resulting from lower than
“normal” production levels.
The
majority of our inventory was included with the second quarter sale of our spine
and orthopedic implant product line to Kensey Nash (see note 5 for a description
of this sale). Our remaining inventory at December 31, 2007 consists
only of raw materials related to our Thin Film products. During the
third quarter of 2007, we recorded a provision of $70,000 for this inventory, as
we determined it unlikely to be converted into finished goods and ultimately
sold. This provision is reflected as a component of research and
development expense rather than as cost of product revenues due to the
inventory’s relationship to Thin Film products, for which we have not yet
achieved commercialization. As of December 31, 2007, our net
inventory balance is zero.
During
the year ended December 31, 2006 and 2005, we recorded a provision of $88,000
and $280,000, respectively, for excess and slow-moving inventory. The
inventory was produced in anticipation of stocking orders from Medtronic which
did not materialize. The provisions have been charged to cost of
sales.
Property
and Equipment
Property
and equipment is stated at cost, net of accumulated depreciation. Depreciation
expense, which includes the amortization of capitalized leasehold improvements,
is provided for on a straight-line basis over the estimated useful lives of the
assets, or the life of the lease, whichever is shorter, and range from three to
five years. When assets are sold or otherwise disposed of, the cost and related
accumulated depreciation are removed from the accounts and the resulting gain or
loss is included in operations. Maintenance and repairs are charged to
operations as incurred.
In the
second and fourth quarters of 2006, we recorded an additional $118,000 and
$108,000 of depreciation expense to accelerate the estimated remaining lives for
certain assets determined to be no longer in use. The second quarter
charge related to furniture and fixtures no longer in use due to our
headquarters relocation, as well as outdated computer software and related
equipment. The assets related to both our regenerative cell
technology and MacroPore Biosurgery operating segments. We recorded
the charge as an increase to general and administrative expenses. The
fourth quarter charge related to leasehold improvements that had a shortened
useful life due to the termination of one of our leases. The charge
was allocated to each department based on square footage occupied at this
terminated location.
Impairment
In
accordance with SFAS No. 144, “Accounting for Impairment or Disposal of
Long-Lived Assets,” we assess certain of our long-lived assets, such as property
and equipment and intangible assets other than goodwill, for potential
impairment when there is a change in circumstances that indicates carrying
values of assets may not be recoverable. Such long-lived assets are deemed to be
impaired when the undiscounted cash flows expected to be generated by the asset
(or asset group) are less than the asset’s carrying amount. Any required
impairment loss would be measured as the amount by which the asset’s carrying
value exceeds its fair value, and would be recorded as a reduction in the
carrying value of the related asset and a charge to operating
expense. We recognized no impairment losses during any of the periods
presented in these financial statements.
Assets
held for sale
In the
third quarter of 2006, we classified certain assets as held for sale, including
certain tangible assets related to our MacroPore Biosurgery product line (note
3). We stopped depreciating these assets in September 2006 and sold
the MacroPore Biosurgery product line to Kensey Nash in May 2007 (note
5).
Goodwill
and Intangibles
SFAS No.
142, “Goodwill and Other Intangible Assets,” establishes financial accounting
and reporting standards for acquired goodwill and other intangible
assets. Under SFAS No. 142, goodwill and indefinite-lived intangible
assets are not amortized but are reviewed at least annually for impairment.
Separable intangible assets that have finite useful lives will continue to be
amortized over their respective useful lives.
57
SFAS No.
142 requires that goodwill be tested for impairment on at least an annual basis
or whenever events or changes in circumstances indicate that the carrying value
of goodwill may not be recoverable. We completed this testing as of November 30,
2007, and concluded that no impairment existed.
In 2007,
all goodwill that had been assigned to our MacroPore Biosurgery reporting unit
sold during our sale of our spine and orthopedic product line to Kensey Nash
(see note 5).
Intangibles,
consisting of patents and core technology purchased in the acquisition of
StemSource, Inc. in 2002, are being amortized on a straight-line basis over
their expected lives of ten years.
The
changes in the carrying amounts of other indefinite and finite-life intangible
assets and goodwill for the years ended December 31, 2007 and 2006 are as
follows:
December 31, 2007
|
||||||||||||
Regenerative
Cell Technology
|
MacroPore
Biosurgery
|
Total
|
||||||||||
Other
intangibles, net:
|
||||||||||||
Beginning
balance
|
$ | 1,300,000 | $ | — | $ | 1,300,000 | ||||||
Amortization
|
(222,000 | ) | — | (222,000 | ) | |||||||
Ending
balance
|
1,078,000 | — | 1,078,000 | |||||||||
Goodwill,
net:
|
||||||||||||
Beginning
balance
|
3,922,000 | 465,000 | 4,387,000 | |||||||||
Disposal
of assets
|
— | (465,000 | ) | (465,000 | ) | |||||||
Ending
balance
|
3,922,000 | — | 3,922,000 | |||||||||
Total
goodwill and other intangibles, net
|
$ | 5,000,000 | $ | — | $ | 5,000,000 | ||||||
Cumulative
amount of amortization charged against intangible assets
|
$ | 1,138,000 | $ | — | $ | 1,138,000 |
December 31, 2006
|
||||||||||||
Regenerative
Cell Technology
|
MacroPore
Biosurgery
|
Total
|
||||||||||
Other
intangibles, net:
|
||||||||||||
Beginning
balance
|
$ | 1,521,000 | $ | — | $ | 1,521,000 | ||||||
Amortization
|
(221,000 | ) | — | (221,000 | ) | |||||||
Ending
balance
|
1,300,000 | — | 1,300,000 | |||||||||
Goodwill,
net:
|
||||||||||||
Beginning
balance
|
3,922,000 | 465,000 | 4,387,000 | |||||||||
Disposal
of assets
|
— | — | — | |||||||||
Ending
balance
|
3,922,000 | 465,000 | 4,387,000 | |||||||||
Total
goodwill and other intangibles, net
|
$ | 5,222,000 | $ | 465,000 | $ | 5,687,000 | ||||||
Cumulative
amount of amortization charged against intangible assets
|
$ | 916,000 | $ | — | $ | 916,000 |
As of
December 31, 2007, future estimated amortization expense for these other
intangible assets is expected to be as follows:
2008
|
222,000
|
|||
2009
|
222,000
|
|||
2010
|
222,000
|
|||
2011
|
222,000
|
|||
2012
|
190,000
|
|||
$
|
1,078,000
|
Revenue
Recognition
Product
Sales
Before
the disposal of our bioresorbable spine and orthopedic product line in May 2007,
we sold our (non-Thin Film) MacroPore Biosurgery products to Medtronic, Inc., a
related party, under a Distribution Agreement dated January 5, 2000 and amended
December 22, 2000 and October 8, 2002, as well as a Development and Supply
Agreement dated January 5, 2000 and amended December 22, 2000 and September 30,
2002. We recognized revenue on product sales to Medtronic only after
shipment of ordered products to Medtronic, as title and risk of loss pass upon
shipment.
In May
2007, we sold to Kensey Nash our intellectual property rights and tangible
assets related to our bioresorbable spine and orthopedic product line (see note
5).
58
License/Distribution
Fees
If
separable under Emerging Issues Task Force Issue 00-21, “Revenue Arrangements
with Multiple Deliverables” (“EITF 00-21”), we recognize any upfront payments
received from license/distribution agreements as revenues over the period in
which the customer benefits from the license/distribution
agreement.
To date,
we have not received any upfront license payments that are separable under EITF
00-21. Accordingly, such license revenues have been combined with
other elements, such as research and development activities, for purposes of
revenue recognition. For instance, we account for the license fees
and milestone payments under the Distribution Agreement with Senko as a single
unit of accounting. Similarly, we have attributed the upfront fees
received under the arrangements with Olympus Corporation, a related party (see
note 4), to a combined unit of accounting comprising a license we granted to
Olympus-Cytori, Inc. (the “Joint Venture”), a related party, as well as
development services we agreed to perform for this entity.
In the
first quarter of 2006, we granted Olympus an exclusive right to negotiate a
commercialization collaboration for the use of adipose stem and regenerative
cells for a specific therapeutic area outside of cardiovascular
disease. In exchange for this right, we received $1,500,000 from
Olympus, which is non-refundable but may be applied towards any definitive
commercial collaboration in the future. As part of this agreement,
Olympus will conduct market research and pilot clinical studies in collaboration
with us over a 12 to 18 month period for the therapeutic area. The
$1,500,000 payment was received in the second quarter of 2006 and recorded as
deferred revenues, related party. The deferred revenues, related
party will be recognized as revenue either (i) in connection with other
consideration received as part of a definitive commercial collaboration in the
future, or (ii) when the exclusive negotiation period expires.
In the
third quarter of 2004, we entered into a Distribution Agreement with
Senko. Under this agreement, we granted to Senko an exclusive license
to sell and distribute certain Thin Film products in Japan and received a
$1,500,000 upfront license fee from them in return for this right. We
have recorded the $1,500,000 received as deferred revenues in the accompanying
consolidated balance sheets. Half of the license fee is refundable if
the parties agree commercialization is not achievable and a proportional amount
is refundable if we terminate the arrangement, other than for material breach by
Senko, before three years post-commercialization.
Research
and Development
We earn
revenue for performing tasks under research and development agreements with both
commercial enterprises, such as Olympus and Senko, and governmental agencies
like the National Institutes of Health (“NIH”). Revenue earned under
development agreements is classified as either research grant or development
revenues in our consolidated statements of operations, depending on the nature
of the arrangement. Revenues derived from reimbursement of direct
out-of-pocket expenses for research costs associated with grants are presented
in compliance with EITF Issue No. 99-19, “Reporting Revenue Gross as a Principal
Versus Net as an Agent,” and EITF Issue No. 01-14, “Income Statement
Characterization of Reimbursements Received for “Out-of-Pocket” Expenses
Incurred.” In accordance with the criteria established by these EITF
Issues, we record grant revenue for the gross amount of the
reimbursement. The costs associated with these reimbursements are
reflected as a component of research and development expense in the consolidated
statements of operations.
Additionally,
research and development arrangements we have with commercial enterprises such
as Olympus and Senko are considered a key component of our central and ongoing
operations. Accordingly, when recognized, the inflows from such
arrangements are presented as revenues in our consolidated statements of
operations.
We
received a total of $22,000,000 from Olympus and Olympus-Cytori, Inc. during
2005 in two separate but related transactions (see note
4). Approximately $4,689,000 of this amount related to common stock
that we issued, as well as two options we granted, to
Olympus. Moreover, during the first quarter of 2006, we received
$11,000,000 from the Joint Venture upon achieving the CE Mark on the Celution™
600. The difference between the proceeds received and the fair values
of the common stock and option liability was recorded as deferred revenue, since
conceptually, the excess proceeds represent a prepayment for future
contributions and obligations of Cytori for the benefit of the Joint Venture (or
“JV”), rather than additional equity investment in
Cytori. Considering the $4,689,000 initially allocated to the common
stock issued and the two options, we recorded upfront fees totaling $28,311,000
as deferred revenues, related party. In exchange for these proceeds,
we agreed to (a) provide Olympus-Cytori, Inc. an exclusive and perpetual license
to our therapeutic device technology, including the Celution™ System platform
and certain related intellectual property, and (b) provide future development
contributions related to commercializing the Celution™ System
platform. As noted above, the license and development services are
not separable under EITF 00-21. The recognition of this deferred
amount will require the achievement of service related milestones, under a
proportional performance methodology. If and as such revenues are
recognized, deferred revenue will be decreased. Proportional
performance methodology was elected due to the nature of our development
obligations and efforts in support of the Joint Venture (“JV”), including
product development activities and regulatory efforts to support the
commercialization of the JV products. The application of this methodology uses
the achievement of R&D milestones as outputs of value to the
JV. We received up-front, non-refundable payments in connection with
these development obligations, which we have broken down into specific R&D
milestones that are definable and substantive in nature, and which will result
in value to the JV when achieved. Revenue will be recognized as the
above mentioned R&D milestones are completed.
59
We
established the R&D milestones based upon our development obligations to the
JV and the specific R&D support activities to be performed to achieve these
obligations. Our R&D milestones consist of the following primary
performance categories: product development, regulatory approvals,
and generally associated pre-clinical and clinical
trials. Within each category are milestones that take
substantive effort to complete and are critical pieces of the overall progress
towards completion of the next generation product, which we are obligated to
support within the agreements entered into with Olympus.
To
determine whether substantive effort was required to achieve the milestones, we
considered the external costs, required personnel and relevant skill levels, the
amount of time required to complete each milestone, and the interdependent
relationships between the milestones, in that the benefits associated with the
completion of one milestone generally support and contribute to the achievement
of the next.
Determination
of the relative values assigned to each milestone involved substantial
judgment. The assignment process was based on discussions with
persons responsible for the development process and the relative costs of
completing each milestone. We considered the costs of completing the
milestones in allocating the portion of the “deferred revenues, related party”
account balance to each milestone. Management believes that, while
the costs incurred in achieving the various milestones are subject to
estimation, due to the high correlation of such costs to outputs achieved, the
use of external contract research organization costs and internal labor costs as
the basis for the allocation process provides management the ability to
accurately and reasonably estimate such costs.
Of the
amounts received and deferred, we recognized development revenues of $5,158,000
and $5,905,000 in the years ended December 31, 2007 and 2006,
respectively. All related development costs are expensed as incurred
and are included in research and development expense on the statement of
operations.
In the
third quarter of 2004, we entered into a Distribution Agreement with
Senko. Under this agreement, we granted to Senko an exclusive license
to sell and distribute certain Thin Film products in Japan. We have
also earned or will be entitled to earn additional payments under the
Distribution Agreement based on achieving the following defined research and
development milestones:
·
|
In
2004, we received a nonrefundable payment of $1,250,000 from Senko after
filing an initial regulatory application with the Japanese Ministry of
Health, Labour and Welfare (“MHLW”) related to the Thin Film product
line. We initially recorded this payment as deferred revenues
of $1,250,000.
|
·
|
Upon
the achievement of commercialization (i.e., regulatory approval by the
MHLW), we will be entitled to an additional nonrefundable payment of
$250,000.
|
Of the
amounts received and deferred, we recognized development revenues of $10,000,
$152,000 and $51,000 in the years ended December 31, 2007, 2006 and 2005,
respectively, representing the fair value of the completed milestones relative
to the fair value of the total efforts expected to be necessary to achieve
regulatory approval by the MHLW. As noted above, the license and the
milestone components of the Senko Distribution Agreement are accounted for as a
single unit of accounting. This single element includes a $1,500,000
license fee which is potentially refundable. We have recognized, and
will continue to recognize, the non-contingent fees allocated to this combined
deliverable as we complete performance obligations under the Distribution
Agreement with Senko. We will not recognize the potentially
refundable portion of the fees until the right of refund expires. See
note 6 for further details. Accordingly, we expect to recognize
approximately $1,129,000 (consisting of remaining $879,000 in deferred revenues
plus a non-refundable payment of $250,000 to be received upon commercialization)
in revenues associated with this milestone arrangement once commercialization is
achieved. We will not recognize the potentially refundable portion of
the fees ($1,500,000) until the right of refund expires.
Under our
agreement with the NIH, we were reimbursed for “qualifying expenditures” related
to research on adipose-derived cell therapy for myocardial
infarction. To receive funds under the grant arrangement, we were
required to (i) demonstrate that we incurred “qualifying expenses,” as defined
in the grant agreement between the NIH and us, (ii) maintain a system of
controls, whereby we could accurately track and report all expenditures related
solely to research on Adipose-Derived Cell Therapy for Myocardial Infarction,
and (iii) file appropriate forms and follow appropriate protocols established by
the NIH. When we were reimbursed for costs incurred under grant
arrangements with the NIH, we recognized revenues for the lesser
of:
60
·
|
Qualifying
costs incurred (and not previously recognized) to date, plus any allowable
grant fees for which we are entitled to funding from the NIH;
or
|
·
|
The
outputs generated to date versus the total outputs expected to be achieved
under the research arrangement.
|
For the
years ended December 31, 2006 and 2005, we recognized NIH grant revenue of
$310,000 and $312,000. Our work under this NIH agreement was
completed in 2006; as a result, there were no comparable revenues or costs in
2007.
Warranty
We
provide a limited warranty under our agreements with our customers for products
that fail to comply with product specifications. We have recorded a reserve for
estimated costs we may incur under our warranty program.
The
following summarizes the movements in our warranty obligations, which is
included in accounts payable and accrued expenses, at December 31, 2007 and
2006:
As of
January 1,
|
Additions/
(Deductions) to
expenses
|
Claims
|
As of
December 31,
|
|||||||||||||
2007:
|
||||||||||||||||
Warranty
obligations
|
$ | 132,000 | $ | (65,000 | ) | $ | — | $ | 67,000 | |||||||
2006:
|
||||||||||||||||
Warranty
obligations
|
$ | 155,000 | $ | (23,000 | ) | $ | — | $ | 132,000 |
Research
and Development
Research
and development expenditures, which are charged to operations in the period
incurred, include costs associated with the design, development, testing and
enhancement of our products, regulatory fees, the purchase of laboratory
supplies, pre-clinical and clinical studies. Included in these expenditures are
salaries and benefits related to these efforts (excluding stock based
compensation), which were approximately $7,777,000 in 2007.
Also
included in research and development expenditures are costs incurred to support
research grant reimbursement and costs incurred in connection with our
development arrangements with Olympus and Senko.
Expenditures
related to the Joint Venture with Olympus include costs that are necessary to
support the commercialization of future generation devices based on our
Celution™ System platform. These development activities, which began in November
2005, include performing pre-clinical and clinical trials, seeking regulatory
approval, and performing product development related to therapeutic applications
for adipose stem and regenerative cells for multiple large markets. For the
years ended December 31, 2007, 2006 and 2005, costs associated with the
development of the device were $6,293,000, $7,286,000 and $1,136,000,
respectively.
Our
agreement with the NIH entitled us to qualifying expenditures of up to $950,000
for Phase I and Phase II related to research on Adipose-Derived Cell Therapy for
Myocardial Infarction. We incurred $479,000 ($169,000 of which were not
reimbursed), and $306,000 of direct expenses for the years ended December 31,
2006 and 2005, respectively. There were no comparable expenditures in 2007 as
our work under the NIH agreement was completed during 2006.
Under a
Distribution Agreement with Senko we are responsible for the completion of the
initial regulatory application to the MHLW and commercialization of the Thin
Film product line in Japan. During the years ended December 31, 2007, 2006 and
2005, we incurred $80,000, $178,000 and $129,000, respectively, of expenses
related to this regulatory and registration process.
Income
Taxes
Income
taxes are accounted for under the asset and liability
method. Deferred tax assets and liabilities are recognized for the
future tax consequences attributable to differences between the financial
statement carrying amounts of existing assets and liabilities and their
respective tax bases and operating loss and tax credit carry
forwards. Deferred tax assets and liabilities are measured using
enacted tax rates expected to apply to taxable income (loss) in the years in
which those temporary differences are expected to be recovered or
settled. Due to our history of loss, a full valuation allowance was
recognized against deferred tax assets.
61
In July
2006, FASB issued Interpretation No. 48, Accounting for Uncertainty in
Income Taxes—An Interpretation of FASB Statement No. 109 (“FIN
48”). FIN 48 clarifies the accounting for uncertainty in income taxes
recognized in an entity’s financial statements in accordance with FASB Statement
No. 109, Accounting for Income Taxes, and prescribes a recognition
threshold and measurement attributes for financial statement disclosure of tax
positions taken or expected to be taken on a tax return. Under FIN 48, the
impact of an uncertain income tax position on the income tax return must be
recognized at the largest amount that is more-likely-than-not to be sustained
upon audit by the relevant taxing authority. An uncertain income tax
position will not be recognized if it has less than a 50% likelihood of being
sustained. Additionally, FIN 48 provides guidance on derecognition,
classification, interest and penalties, accounting in interim periods,
disclosure and transition.
Stock
Based Compensation
Accounting
Policy
On
January 1, 2006, we adopted the provisions of Financial Accounting Standards
Board Statement No. 123R, “Share-Based Payment” (“SFAS 123R”) using the modified
prospective transition method. SFAS 123R requires us to measure all share-based
payment awards granted after January 1, 2006, including those with employees, at
fair value. Under SFAS 123R, the fair value of stock options and
other equity-based compensation must be recognized as expense in the statements
of operations over the requisite service period of each award.
In
addition, beginning January 1, 2006, we have recognized compensation expense
under SFAS 123R for the unvested portions of outstanding share-based awards
previously granted under our (a) 2004 Equity Incentive Plan and (b) 1997 Stock
Option and Stock Purchase Plan, over the periods these awards continue to
vest. This compensation expense is recognized based on the fair
values and attribution methods that were previously disclosed in our prior
period financial statements under Financial accounting Standards Board Statement
No. 123, “Accounting for Stock-Based Compensation” (“SFAS 123”).
Prior to
January 1, 2006, we applied the intrinsic value-based method of accounting for
share-based payment transactions with our employees, as prescribed by Accounting
Principles Board (“APB”) Opinion No. 25, “Accounting for Stock Issued to
Employees,” and related interpretations including Financial Accounting Standards
Board Interpretation No. 44, “Accounting for Certain Transactions Involving
Stock Compensation-An Interpretation of APB Opinion No. 25.” Under
the intrinsic value method, compensation expense was recognized only if the
current market price of the underlying stock exceeded the exercise price of the
share-based payment award as of the measurement date (typically the date of
grant). SFAS 123 established accounting and disclosure requirements
using a fair value-based method of accounting for stock-based employee
compensation plans. As permitted by SFAS 123 and by Statement of
Financial Accounting Standards No. 148, “Accounting for Stock-Based
Compensation—Transition and Disclosure,” we disclosed on a pro forma basis the
net loss and loss per share that would have resulted had we adopted SFAS 123 for
measurement purposes.
Fair
value under SFAS 123 is determined using the Black-Scholes option-pricing model
with the following assumptions:
For
the year ended December 31, 2005
|
||||
Expected
term
|
8
years
|
|||
Risk
free interest rate
|
3.9-4.4 | % | ||
Volatility
|
80 | % | ||
Dividends
|
— | |||
Resulting
weighted average grant date fair value
|
$ | 3.25 |
Had
compensation expense been recognized for stock-based compensation plans in
accordance with SFAS 123, we would have recorded the following net loss and net
loss per share amounts:
For
the year ended December 31, 2005
|
||||
Net
loss:
|
||||
As
reported
|
$ | (26,538,000 | ) | |
Add:
Employee stock-based compensation expense included in reported net loss,
net of related tax effects
|
341,000 | |||
Deduct:
Total employee stock-based compensation expense determined under the fair
value method for all awards, net of related tax effects
|
(2,675,000 | ) | ||
Pro
forma
|
$ | (28,872,000 | ) | |
Basic
and diluted loss per common share:
|
||||
As
reported
|
$ | (1.80 | ) | |
Pro
forma
|
$ | (1.96 | ) |
62
Other
Comprehensive Income (Loss)
Comprehensive
income (loss) is the total of net income (loss) and all other non-owner changes
in equity. Other comprehensive income (loss) refers to these revenues, expenses,
gains, and losses that, under generally accepted accounting principles, are
included in comprehensive income (loss) but excluded from net income
(loss).
During
the years ended December 31, 2007, 2006 and 2005, our only element of other
comprehensive income (loss) resulted from unrealized gains (losses) on
available-for-sale investments, which are reflected in the consolidated
statements of stockholders’ equity as accumulated other comprehensive income
(loss).
Segment
Information
On July
11, 2005, we announced the reorganization of our business based on two distinct
operating segments – (a) Regenerative cell technology and (b) MacroPore
Biosurgery, which manufactures bioresorbable implants. In the past,
our resources were managed on a consolidated basis. However, in an
effort to better reflect our focus and significant progress in the development
of regenerative therapies, we decided to, and therefore report, our financial
results in two segments.
Our
regenerative cell technology segment develops, manufactures and sells medical
technologies to enable the practice of regenerative medicine with an initial
focus on reconstructive surgery and cell banking. Our
commercialization model is based on the sale of Celution™ Systems and their
related harvest and delivery instrumentation, and on generating recurring
revenues from single-use consumable sets utilized during each patient
procedure.
Our
MacroPore Biosurgery unit develops Thin Film bioresorbable implants for sale in
Japan through Senko Medical Trading Company (“Senko”), which has exclusive
distribution rights to these products in Japan. Also, until after the
second quarter of 2007, the MacroPore Biosurgery segment manufactured and
distributed the HYDROSORB™ family of spine and orthopedic implants.
We
measure the success of each operating segment based on operating profits and
losses and, additionally, in the case of the regenerative cell technology
segment, the achievement of key research objectives. In arriving at
our operating results for each segment, we use the same accounting policies as
those used for our consolidated company and as described throughout this
note. However, segment operating results exclude allocations of
company-wide general and administrative costs and changes in fair value of our
option liabilities.
During
the second half of 2007, we noted minimal activity in the MacroPore Biosurgery
operating segment as a result of sale in May 2007 to Kensey Nash of the
intellectual property rights and tangible assets related to the spine and
orthopedic bioresorbable implant product line. However, due to
production and sales activity in the MacroPore Biosurgery operating segment
prior to the sale to Kensey Nash, we have reported two operating segments
through December 31, 2007.
Prior
year results presented below have been developed on the same basis as the
current year amounts. For all periods presented, we did not have any
intersegment transactions.
The
following tables provide information regarding the performance and assets of our
operating segments:
Year ended December 31,
|
||||||||||||
2007
|
2006
|
2005
|
||||||||||
Revenues:
|
||||||||||||
Regenerative
cell technology
|
$ | 5,247,000 | $ | 6,324,000 | $ | 320,000 | ||||||
MacroPore
Biosurgery
|
802,000 | 1,603,000 | 5,685,000 | |||||||||
Total
revenues
|
$ | 6,049,000 | $ | 7,927,000 | $ | 6,005,000 | ||||||
Segment
operating income (losses):
|
||||||||||||
Regenerative
cell technology
|
$ | (17,075,000 | ) | $ | (16,211,000 | ) | $ | (13,170,000 | ) | |||
MacroPore
Biosurgery
|
9,000 | (1,528,000 | ) | (976,000 | ) | |||||||
General
and administrative expenses
|
(14,184,000 | ) | (12,547,000 | ) | (10,208,000 | ) | ||||||
Changes
in fair value of option liabilities
|
(100,000 | ) | 4,431,000 | (3,645,000 | ) | |||||||
Total
operating loss
|
$ | (31,350,000 | ) | $ | (25,855,000 | ) | $ | (27,999,000 | ) |
As of December 31,
|
||||||||
2007
|
2006
|
|||||||
Assets:
|
||||||||
Regenerative
cell technology
|
$ | 11,591,000 | $ | 9,792,000 | ||||
MacroPore
Biosurgery
|
— | 1,758,000 | ||||||
Corporate
assets
|
9,916,000 | 13,318,000 | ||||||
Total
assets
|
$ | 21,507,000 | $ | 24,868,000 |
63
We
derived our revenues from the following products, research grants, development
and service activities:
Years ended December 31,
|
||||||||||||
2007
|
2006
|
2005
|
||||||||||
Regenerative
cell technology:
|
||||||||||||
Development
revenues:
|
||||||||||||
Milestone
revenue (Olympus)
|
$ | 5,158,000 | $ | 5,905,000 | $ | — | ||||||
Research
grant (NIH)
|
— | 310,000 | 312,000 | |||||||||
Regenerative
cell storage services
|
4,000 | 7,000 | 8,000 | |||||||||
Other
|
85,000 | 102,000 | — | |||||||||
Total
regenerative cell technology
|
5,247,000 | 6,324,000 | 320,000 | |||||||||
MacroPore
Biosurgery:
|
||||||||||||
Product
revenues:
|
||||||||||||
Spine
& orthopedic products
|
792,000 | 1,451,000 | 5,634,000 | |||||||||
Development
revenues
|
10,000 | 152,000 | 51,000 | |||||||||
Total
MacroPore Biosurgery
|
802,000 | 1,603,000 | 5,685,000 | |||||||||
Total
revenues
|
$ | 6,049,000 | $ | 7,927,000 | $ | 6,005,000 |
The
following table provides geographical information regarding our sales to
external customers:
For the Years Ended
December 31,
|
U.S. Revenues
|
Non-U.S. Revenues
|
Total Revenues
|
|||||||||
2007
|
$ | 6,010,000 | $ | 39,000 | $ | 6,049,000 | ||||||
2006
|
$ | 7,827,000 | $ | 100,000 | $ | 7,927,000 | ||||||
2005
|
$ | 6,005,000 | $ | — | $ | 6,005,000 |
At
December 31, 2007 and 2006, our long-lived assets, net of depreciation,
excluding goodwill and intangibles (all of which are domiciled in the U.S.), are
located in the following jurisdictions:
As of
December 31,
|
U.S. Domiciled
|
Non-U.S. Domiciled
|
Total
|
|||||||||
2007
|
$ | 3,932,000 | $ | 337,000 | $ | 4,269,000 | ||||||
2006
|
$ | 4,995,000 | $ | 208,000 | $ | 5,203,000 |
Loss
Per Share
We
compute loss per share based on the provisions of SFAS No. 128, “Earnings Per
Share.” Basic per share data is computed by dividing net income or loss
available to common stockholders by the weighted average number of common shares
outstanding during the period. Diluted per share data is computed by dividing
net income or loss available to common stockholders by the weighted average
number of common shares outstanding during the period increased to include, if
dilutive, the number of additional common share equivalents that would have been
outstanding if potential common shares had been issued using the treasury stock
method. Potential common shares were related entirely to outstanding but
unexercised option awards and warrants for all periods presented.
We have
excluded all potentially dilutive securities from the calculation of diluted
loss per share attributable to common stockholders for the years ended December
31, 2007, 2006 and 2005, as their inclusion would be antidilutive. Potentially
dilutive common shares excluded from the calculations of diluted loss per share
were 6,007,275, 5,934,029, and 7,984,741, for the years ended December 31, 2007,
2006 and 2005, respectively.
Potential
common shares in 2005 include a now-expired option to purchase 2,200,000 shares
related to the Olympus equity agreement (see note 4).
Recent
Accounting Pronouncements
In June
2006, the FASB issued Interpretation No. 48, “Accounting for Uncertainty in
Income Taxes” (“FIN 48”). This is an interpretation of Statement of
Financial Accounting Standards No. 109, “Accounting for Income
Taxes.” It prescribes a recognition threshold and measurement
attribute for the financial statement recognition and measurement of a tax
position taken or expected to be taken in a tax return. FIN 48 also
provides guidance on derecognition, classification, interest and penalties,
accounting in interim periods, disclosure and transition. We adopted
this interpretation effective January 1, 2007. The adoption of FIN 48
did not have a significant effect on our consolidated financial
statements.
In
September 2006, the FASB issued SFAS No. 157, “Fair Value Measurements” (“SFAS
157”). SFAS 157 defines fair value, establishes a framework for measuring fair
value and expands disclosure of fair value measurements. SFAS 157 applies under
other accounting pronouncements that require or permit fair value measurements
and accordingly, does not require any new fair value measurements. SFAS 157 was
initially effective for financial statements issued for fiscal years beginning
after November 15, 2007. In February 2008, the FASB issued staff position
FAS 157-2, which delays the effective date of SFAS 157 for certain nonfinancial
assets and liabilities for fiscal years beginning after November 15, 2008.
We do not believe that the adoption of SFAS 157 will have a significant effect
on our consolidated financial statements.
64
In March
2007, the FASB ratified the consensus reached by the Emerging Issues Task Force
on Issue No. 07-3, “Accounting for Nonrefundable Advance Payments for Goods or
Services to Be Used in Future Research and Development Activities” (“EITF
07-3”). EITF 07-3 states that nonrefundable advance payments for
future research and development activities should be deferred and
capitalized. Such amounts should be recognized as an expense as the
goods are delivered or the related services are performed. The
guidance is effective for all periods beginning after December 15, 2007. We are
currently in the process of evaluating whether the adoption of EITF 07-3 will
have a significant effect on our consolidated financial statements.
In
February 2007, the FASB issued SFAS 159, “The Fair Value Option for Financial
Assets and Financial Liabilities- Including an amendment of FASB Statement
No. 115” (“SFAS 159”), which permits entities to choose to measure many
financial instruments and certain other items at fair value. The provisions of
SFAS 159 are effective for financial statements issued for fiscal years
beginning after November 15, 2007. We do not believe that the
adoption of SFAS 159 will have a significant effect on our consolidated
financial statements.
In
December 2007, the FASB issued SFAS No. 160, “Noncontrolling Interests in
Consolidated Financial Statements - An Amendment of ARB No. 51” ("SFAS
160"). SFAS 160 establishes new accounting and reporting standards
for the noncontrolling interest in a subsidiary and for the deconsolidation of a
subsidiary. SFAS 160 is effective for annual periods beginning on or after
December 15, 2008. We do not believe that the adoption of SFAS 160
will have a significant effect on our consolidated financial
statements.
In
December 2007, the FASB issued SFAS No. 141 (revised 2007), “Business
Combinations” ("SFAS 141R"). SFAS 141R retains the fundamental
requirements of Statement No. 141 to account for all business combinations using
the acquisition method (formerly the purchase method) and for an acquiring
entity to be identified in all business combinations. However, the
new standard requires the acquiring entity in a business combination to
recognize all the assets acquired and liabilities assumed in the transaction;
establishes the acquisition-date fair value as the measurement objective for all
assets acquired and liabilities assumed; and requires the acquirer to disclose
the information they need to evaluate and understand the nature and financial
effect of the business combination. SFAS 141R is effective for
acquisitions made on or after the first day of annual periods beginning on or
after December 15, 2008. We do not believe that the adoption of SFAS
141R will have a significant effect on our consolidated financial
statements.
In
December 2007, the FASB ratified the consensus reached by the Emerging Issues
Task Force (EITF) on EITF Issue 07-1, “Accounting for Collaborative
Arrangements” (“EITF 07-1”). EITF 07-1 requires collaborators to
present the results of activities for which they act as the principal on a gross
basis and report any payments received from (made to) other collaborators based
on other applicable GAAP or, in the absence of other applicable GAAP, based on
analogy to authoritative accounting literature or a reasonable, rational, and
consistently applied accounting policy election. The guidance is
effective for fiscal years beginning after December 15, 2008. We are
currently in the process evaluating whether the adoption of EITF 07-1 will have
a significant effect on our consolidated financial statements.
3.
|
Assets
Held for Sale
|
We have
begun to focus our efforts exclusively on the regenerative cell therapy segment
of our business. As a result, in 2006, the Board of Directors decided
to divest our remaining MacroPore Biosurgery assets as a means to fund our
continuing efforts in our regenerative cell therapy segment. This
decision was based on the change in our strategic focus as well as the
continuing negative profit margins being realized from the MacroPore Biosurgery
segment. We sold intellectual property rights and tangible assets
related to the spine and orthopedic bioresorbable implant product line to
Kensey Nash in May 2007. See note 5 for further details.
4.
|
Transactions
with Olympus Corporation
|
Initial
Investment by Olympus Corporation in Cytori
In the
second quarter of 2005, we entered into a common stock purchase agreement (the
“Purchase Agreement”) with Olympus in which we received $11,000,000 in cash
proceeds.
Under
this agreement, we issued 1,100,000 shares of common stock to
Olympus. In addition, we also granted Olympus an immediately
exercisable option to acquire 2,200,000 shares of our common stock at $10 per
share, which expired on December 31, 2006. Before its expiration, we
accounted for this option as a liability in accordance with EITF 00-19,
“Accounting for Derivative Financial Instruments Indexed to, and Potentially
Settled in, a Company's Own Stock” because from the date of grant through the
expiration, we would have been required to deliver listed common stock to settle
the option shares upon exercise.
65
The
$11,000,000 in total proceeds we received in the second quarter of 2005 exceeded
the sum of (i) the market value of our stock as well as (ii) the fair value of
the option at the time we entered into the share purchase
agreement. The $7,811,000 difference between the proceeds received
and the fair values of our common stock and option liability is recorded as a
component of deferred revenues, related party in the accompanying balance
sheet. This difference was recorded as deferred revenue since,
conceptually, the excess proceeds represent a prepayment for future
contributions and obligations of Cytori for the benefit of the Joint Venture
(see below), rather than an additional equity investment in
Cytori. The recognition of this deferred amount will require the
achievement of related milestones, under a proportional performance
methodology. If and such revenues are recognized, deferred revenue
will be decreased (see note 2 – Revenue Recognition).
In a
separate agreement entered into on February 23, 2006, we granted Olympus an
exclusive right to negotiate a commercialization collaboration for the use of
adipose regenerative cells for a specific therapeutic area outside of
cardiovascular disease. In exchange for this right, we received a
$1,500,000 payment from Olympus. As part of this agreement, Olympus
will conduct market research and pilot clinical studies in collaboration with us
for the therapeutic area up to December 31, 2008 when this exclusive right will
terminate.
In August
2006, we received an additional $11,000,000 from Olympus for the issuance of
approximately 1,900,000 shares of our common stock at $5.75 per share under the
shelf registration statement filed in May 2006. The purchase price
was determined by our closing price on August 9, 2006.
As of
December 31, 2007, Olympus holds approximately 12.5% of our issued and
outstanding shares. Additionally, Olympus has a right, which it has
not yet exercised, to designate a director to serve on our Board of
Directors.
Formation
of the Olympus-Cytori Joint Venture
On
November 4, 2005, we entered into a joint venture and other related agreements
(the “Joint Venture Agreements”) with Olympus. The Joint Venture is
owned equally by Olympus and us.
Under the
Joint Venture Agreements:
·
|
Olympus
paid $30,000,000 for its 50% interest in the Joint
Venture. Moreover, Olympus simultaneously entered into a
License/Joint Development Agreement with the Joint Venture and us to
develop a second generation commercial system and manufacturing
capabilities.
|
·
|
We
licensed our device technology, including the Celution™ System platform
and certain related intellectual property, to the Joint Venture for use in
future generation devices. These devices will process and
purify regenerative cells residing in adipose tissue for various
therapeutic clinical applications. In exchange for this
license, we received a 50% interest in the Joint Venture, as well as an
initial $11,000,000 payment from the Joint Venture; the source of this
payment was the $30,000,000 contributed to the Joint Venture by
Olympus. Moreover, upon receipt of a CE mark for the Celution™
600 in January 2006, we received an additional $11,000,000 development
milestone payment from the Joint
Venture.
|
We have
determined that the Joint Venture is a variable interest entity (“VIE”) pursuant
to FASB Interpretation No. 46 (revised 2003), “Consolidation of Variable
Interest Entities - an interpretation of ARB No. 51” (“FIN 46R”), but that
Cytori is not the VIE’s primary beneficiary. Accordingly, we have
accounted for our interests in the Joint Venture using the equity method of
accounting, since we can exert significant influence over the Joint Venture’s
operations. At December 31, 2007, the carrying value of our
investment in the Joint Venture is $369,000.
We are
under no obligation to provide additional funding to the Joint Venture, but may
choose to do so. We contributed $300,000 and $150,000 to the Joint
Venture during 2007 and 2006, respectively.
Put/Calls
and Guarantees
The
Shareholders’ Agreement between Cytori and Olympus provides that in certain
specified circumstances of insolvency or if we experience a change in control,
Olympus will have the rights to (i) repurchase our interests in the Joint
Venture at the fair value of such interests or (ii) sell its own interests in
the Joint Venture to Cytori at the higher of (a) $22,000,000 or (b) the Put’s
fair value.
66
As of
November 4, 2005, the fair value of the Put was determined to be
$1,500,000. At December 31, 2007 and 2006, the fair value of the Put
was $1,000,000 and $900,000, respectively. Fluctuations in the Put
value are recorded in the consolidated statements of operations as a component
of change in fair value of option liabilities. The fair value of the Put has
been recorded as a long-term liability in the caption option liability in our
consolidated balance sheets.
The
valuations of the Put were completed using an option pricing theory based
simulation analysis (i.e., a Monte Carlo simulation). The valuations
are based on assumptions as of the valuation date with regard to the market
value of Cytori and the estimated fair value of the Joint Venture, the expected
correlation between the values of Cytori and the Joint Venture, the expected
volatility of Cytori and the Joint Venture, the bankruptcy recovery rate for
Cytori, the bankruptcy threshold for Cytori, the probability of a change of
control event for Cytori, and the risk free interest rate.
The
following assumptions were employed in estimating the value of the
Put:
December
31, 2007
|
December
31, 2006
|
November
4, 2005
|
||||||||||
Expected
volatility of
Cytori
|
60.00 | % | 66.00 | % | 63.20 | % | ||||||
Expected
volatility of the Joint Venture
|
60.00 | % | 56.60 | % | 69.10 | % | ||||||
Bankruptcy
recovery rate for
Cytori
|
21.00 | % | 21.00 | % | 21.00 | % | ||||||
Bankruptcy
threshold for
Cytori
|
$ | 9,324,000 | $ | 10,110,000 | $ | 10,780,000 | ||||||
Probability
of a change of control event for Cytori
|
2.17 | % | 1.94 | % | 3.04 | % | ||||||
Expected
correlation between fair values of Cytori and the Joint Venture in the
future
|
99.00 | % | 99.00 | % | 99.00 | % | ||||||
Risk
free interest
rate
|
4.04 | % | 4.71 | % | 4.66 | % |
The Put
has no expiration date. Accordingly, we will continue to recognize a
liability for the Put and mark it to market each quarter until it is exercised
or until the arrangements with Olympus are amended.
Olympus-Cytori
Joint Venture
The Joint
Venture has exclusive access to our technology for the development, manufacture,
and supply of the devices (second generation and beyond) for all therapeutic
applications. Once a later generation Celution™ System is developed
and approved by regulatory agencies, the Joint Venture may sell such systems
exclusively to us at a formula-based transfer price; we have retained marketing
rights to the second and all subsequent generation devices for all therapeutic
applications of adipose regenerative cells.
As part
of the various agreements with Olympus, we will be required, following
commercialization of the Joint Venture’s Celution™ System or Systems, to provide
monthly forecasts to the Joint Venture specifying the quantities of each
category of devices that we intend to purchase over a rolling six-month
period. Although we are not subject to any minimum purchase
requirements, we are obliged to buy a minimum percentage of the products
forecasted by us in such reports. Since we can effectively control
the number of devices we will agree to purchase and because no commercial
devices have yet been developed to trigger the forecast requirement, we estimate
that the fair value of this guarantee is de minimis as of December 31,
2007.
In August
2007 we entered into a License and Royalty Agreement (“Royalty Agreement”) with
the Joint Venture which provides us the ability to commercially launch the
Celution™ System platform earlier than we could have otherwise done so under the
terms of the Joint Venture Agreements. The Royalty Agreement allows
for the sale of the Cytori system until such time as the Joint Venture’s
products are commercially available, subject to a reasonable royalty that will
be payable to the Joint Venture for all such sales.
Deferred
revenues, related party
As of
December 31, 2007, the deferred revenues, related party account primarily
consists of the consideration we have received in exchange for contributions and
obligations that we have agreed to on behalf of Olympus and the Joint Venture
(less any amounts that we have recognized as revenues in accordance with our
revenue recognition policies set out in note 2). These contributions
include product development, regulatory approvals, and generally associated
pre-clinical and clinical trials to support the commercialization of the
Celution™ System platform. Our obligations also include maintaining
the exclusive and perpetual license to our device technology, including the
Celution™ System platform and certain related intellectual
property.
Pursuant
to EITF 00-21, we have concluded that the license and development services must
be accounted for as a single unit of accounting. Refer to note 2 for
a full description of our revenue recognition policy.
67
Condensed
financial information for the Joint Venture
A summary
of the unaudited condensed financial information for the Joint Venture as of
December 31, 2007 and 2006 and for the periods from January 1 to December 31,
2007 and 2006 and from November 4, 2005 (inception) to December 31, 2005 is as
follows:
As
of December 31, 2007
|
As
of December 31, 2006
|
|||||||
(Unaudited)
|
(Unaudited)
|
|||||||
Balance
Sheets
|
||||||||
Assets:
|
||||||||
Cash
|
$ | 713,000 | $ | 173,000 | ||||
Prepaid
insurance
|
9,000 | 15,000 | ||||||
Computer
equipment and software, net
|
24,000 | — | ||||||
Total
assets
|
$ | 746,000 | $ | 188,000 | ||||
Liabilities
and Stockholders’ Equity:
|
||||||||
Accrued
expenses
|
$ | 27,000 | $ | 62,000 | ||||
Amounts
due to related
party
|
72,000 | — | ||||||
Stockholders’
equity
|
647,000 | 126,000 | ||||||
Total
liabilities and stockholders’ equity
|
$ | 746,000 | $ | 188,000 |
Period
from January 1, 2007 to December 31, 2007
|
Period
from January 1, 2006 to December 31, 2006
|
Period
from November 4, 2005 (inception) to December 31, 2005
|
||||||||||
(Unaudited)
|
(Unaudited)
|
(Unaudited)
|
||||||||||
Statements
of Operation
|
||||||||||||
Research
and development expense
|
$ | — | $ | 11,000,000 | $ | 19,343,000 | ||||||
General
and administrative expense
|
79,000 | 174,000 | — | |||||||||
Net
loss
|
$ | (79,000 | ) | $ | (11,174,000 | ) | $ | (19,343,000 | ) |
5.
|
Gain
on Sale of Assets
|
Spine
& Orthopedics Product Line
In May
2007, we sold to Kensey Nash our intellectual property rights and tangible
assets related to our spine and orthopedic bioresorbable implant product line, a
part of our MacroPore Biosurgery business. Excluded from the sale was
our Japan Thin Film product line.
We
received $3,175,000 in cash related to the disposition. The assets
comprising the spine and orthopedic product line transferred to Kensey Nash were
as follows:
Carrying
Value Prior to Disposition
|
||||
Inventory
|
$ | 94,000 | ||
Other
current assets
|
17,000 | |||
Assets
held for sale
|
436,000 | |||
Goodwill
|
465,000 | |||
$ | 1,012,000 |
We
incurred expenses of $109,000 in connection with the sale during the second
quarter of 2007. As part of the disposition agreement, we were
required to provide training to Kensey Nash representatives in all aspects of
the manufacturing process related to the transferred spine and orthopedic
product line, and to act in the capacity of a product manufacturer from the
point of sale through August 2007. Because of these additional
manufacturing requirements, we deferred $196,000 of the gain related to the
outstanding manufacturing requirements, and we recognized $1,858,000 as a gain
on sale in the statement of operations during the second quarter of
2007. These manufacturing requirements were completed in August as
planned, and the associated costs were classified against the deferred balance,
reducing it to zero. As of December 31, 2007, no further costs or
adjustments relating to this product line sale are anticipated.
68
The
revenues and expenses related to the spine and orthopedic product line sold to
Kensey Nash for the years ended December 31, 2007, 2006 and 2005, were as
follows:
For
the years ended December 31,
|
||||||||||||
2007
|
2006
|
2005
|
||||||||||
Revenues
|
$ | 792,000 | $ | 1,451,000 | $ | 5,634,000 | ||||||
Cost
of product revenues
|
(422,000 | ) | (1,634,000 | ) | (3,154,000 | ) | ||||||
Research
& development
|
(113,000 | ) | (1,052,000 | ) | (2,325,000 | ) | ||||||
Sales
& marketing
|
(21,000 | ) | (163,000 | ) | (501,000 | ) |
Thin
Film Product Line
In May
2004, we sold most, but not all, of our intellectual property rights and
tangible assets related to our Thin Film product line to MAST (see note
6). The assets comprising the Thin Film product line sold to MAST
were as follows:
Carrying
Value Prior to Disposition
|
||||
Finished
goods inventory
|
$ | 177,000 | ||
Manufacting
and development equipment
|
217,000 | |||
Goodwill
|
240,000 | |||
$ | 634,000 |
Under
this agreement we were contractually entitled to the following additional
consideration (none of this consideration has been recognized in the financial
statements):
·
|
$200,000,
payable only upon receipt of 510(k) clearance from the U.S. Food and Drug
Administration (“FDA”) for a hernia wrap product (thin film combined
product); and
|
·
|
$2,000,000
on or before the earlier of (i) May 31, 2005, known as the “Settlement
Date,” or (ii) 15 days after the date upon which MAST has hired a Chief
Executive Officer (“CEO”), provided the CEO held that position for at
least four months and met other requirements specified in the sale
agreement. Note that clause (ii) effectively means that we
would not have received payment of $2,000,000 before May 31, 2005 unless
MAST had hired a CEO on or before January 31, 2005 (four months prior to
the Settlement Date). Moreover, in the event that MAST had not
hired a CEO on or before January 31, 2005, MAST may have (at its sole
option and subject to the requirements of the sale agreement)
alternatively provided us with a 19% equity interest in the MAST business
that is managing the Thin Film assets at May 31, 2005 in lieu of making
the $2,000,000 payment. Our contention was that
MAST did in fact hire a CEO on or before January 31, 2005, and thus, we
were entitled to a $2,000,000 cash payment on or before May 31,
2005.
|
MAST did
not make the payments specified above. Therefore, on June 14, 2005,
we initiated arbitration proceedings against MAST, asserting that MAST was in
breach of the Asset Purchase Agreement by failing to pay the final $2,000,000 in
purchase price (among other issues). MAST responded asserting its own
claims on or about June 23, 2005. MAST’s claims included but were not
limited to the following allegations: (i) we inadequately transferred know-how
to MAST, (ii) we misrepresented the state of the distribution network, (iii) we
provided inadequate product instructions to users, and (iv) we failed to
adequately train various distributors.
In August
2005, the parties settled the arbitration proceedings and gave mutual releases
of all claims, excepting those related to the territory of Japan, and agreed to
contractual compromises, the most significant of which was our waiving of the
obligation for MAST to either pay the final cash purchase installment of
$2,000,000 or to deliver 19% of its shares.
In
exchange, MAST agreed to supply - at no cost to us - all required product for
any necessary clinical study for the territory of Japan and to cooperate in the
planning of such study. However, if we enter into a supply agreement
with MAST for the territory of Japan, we would be obliged to reimburse MAST for
any Thin Film product supplied in connection with the Japanese study at a cost
of $50 per sheet.
As a
result of the arbitration settlement, we recognized the remaining deferred gain
on sale of assets of $5,650,000, less $124,000 of related deferred costs, in the
consolidated statement of operations in the third quarter of 2005.
69
6.
|
Thin
Film Japan Distribution Agreement
|
In the
third quarter of 2004, we entered into a Distribution Agreement with
Senko. Under this agreement, we granted to Senko an exclusive license
to sell and distribute certain Thin Film products in
Japan. Specifically, the license covers Thin Film products with the
following indications:
·
|
Anti-adhesion,
|
·
|
Soft
tissue support, and
|
·
|
Minimization
of the attachment of soft tissues throughout the
body.
|
The
Distribution Agreement with Senko commences upon
“commercialization.” Essentially, commercialization occurs when one
or more Thin Film product registrations are completed with the
MHLW.
Following
commercialization, the Distribution Agreement has a duration of five years and
is renewable for an additional five years after reaching mutually agreed minimum
purchase guarantees.
The
Distribution Agreement also provides for us to supply certain products to Senko
at fixed prices over the life of the agreement once we have received approval to
market these products in Japan. In addition to the product price,
Senko will also be obligated to make royalty payments to us of 5% of the sales
value of any products Senko sells to its customers during the first three years
post-commercialization.
At the
inception of this arrangement, we received a $1,500,000 license fee which was
recorded as deferred revenues in 2004. We have also received
$1,250,000 in milestone payments from Senko. See “Revenue Recognition” under
note 2 above for our policies with regard to the timing of when these amounts
will be recognized as revenues.
As part
of the Thin Film sales agreement (see note 5), we granted MAST a right to
acquire our Thin Film-related interest in Japan. This right expired
unexercised on May 31, 2007.
7.
|
Short-term
Investments
|
Our
short-term investment balance is $0 as of December 31, 2007, as all our excess
cash is included with cash and cash equivalents in the accompanying consolidated
balance sheets.
As of
December 31, 2006, all short-term investments were classified as
available-for-sale, which consisted of the following:
December 31, 2006
|
||||||||||||||||||||||||||||
Less than 12 months
temporary impairment
|
Greater than 12 months
temporary impairment
|
Total
|
||||||||||||||||||||||||||
Amortized
Cost
|
Gross
Unrealized
Losses
|
Estimated
Fair Value
|
Gross
Unrealized
Losses
|
Estimated
Fair Value
|
Gross
Unrealized
Losses
|
Estimated
Fair Value
|
||||||||||||||||||||||
Corporate
notes and bonds
|
$ | 599,000 | $ | — | $ | 599,000 | $ | — | $ | — | $ | — | $ | 599,000 | ||||||||||||||
Agency
securities
|
3,377,000 | — | 3,377,000 | — | — | — | 3,377,000 | |||||||||||||||||||||
Total
|
$ | 3,976,000 | $ | — | $ | 3,976,000 | $ | — | $ | — | $ | — | $ | 3,976,000 |
As of
December 31, 2006, investments available-for-sale had less than one year
maturities as follows:
December 31, 2006
|
||||
Amortized
Cost
|
||||
Corporate
notes and bonds:
|
||||
with
maturity of less than 1 year
|
$ | 599,000 | ||
with
maturity of 1 to 2 years
|
— | |||
Agency
securities:
|
||||
with
maturity of less than 1 year
|
3,377,000 | |||
with
maturity of 1 to 2 years
|
— | |||
$ | 3,976,000 |
Proceeds
from sales and maturity of short term investments for the year ended December
31, 2007, 2006 and 2005 were $28,007,000, $67,137,000 and $56,819,000,
respectively. Gross realized losses for such sales were approximately $0, $1,000
and $12,000 in 2007, 2006 and 2005, respectively.
70
8.
|
Composition
of Certain Financial Statement
Captions
|
Inventories,
net
As of
December 31, 2007 and 2006, inventories, net, were comprised of the
following:
December
31,
|
December
31,
|
|||||||
2007
|
2006
|
|||||||
Raw
materials
|
$ | — | $ | 136,000 | ||||
Finished
goods
|
— | 28,000 | ||||||
$ | — | $ | 164,000 |
Other
Current Assets
As of
December 31, 2007 and 2006, other current assets were comprised of the
following:
December
31,
|
December
31,
|
|||||||
2007
|
2006
|
|||||||
Prepaid
insurance
|
$ | 287,000 | $ | 214,000 | ||||
Prepaid
other
|
411,000 | 434,000 | ||||||
Accrued
interest receivable
|
— | 19,000 | ||||||
Other
receivables
|
66,000 | 44,000 | ||||||
$ | 764,000 | $ | 711,000 |
Property
and Equipment, net
As of
December 31, 2007 and 2006, property and equipment, net, were comprised of the
following:
December
31,
|
December
31,
|
|||||||
2007
|
2006
|
|||||||
Manufacturing
and development equipment
|
$ | 2,833,000 | $ | 2,980,000 | ||||
Office
and computer equipment
|
2,430,000 | 2,653,000 | ||||||
Leasehold
improvements
|
3,124,000 | 3,085,000 | ||||||
8,387,000 | 8,718,000 | |||||||
Less
accumulated depreciation and amortization
|
(4,955,000 | ) | (4,476,000 | ) | ||||
$ | 3,432,000 | $ | 4,242,000 |
Accounts
Payable and Accrued Expenses
As of
December 31, 2007 and 2006, accounts payable and accrued expenses were comprised
of the following:
December
31,
|
December
31,
|
|||||||
2007
|
2006
|
|||||||
Accrued
legal fees
|
$ | 2,749,000 | $ | 1,630,000 | ||||
Accrued
R&D studies
|
1,263,000 | 1,064,000 | ||||||
Accounts
payable
|
479,000 | 729,000 | ||||||
Accrued
vacation
|
816,000 | 628,000 | ||||||
Accrued
bonus
|
886,000 | 661,000 | ||||||
Accrued
expenses
|
623,000 | 371,000 | ||||||
Deferred
rent
|
265,000 | 239,000 | ||||||
Warranty
reserve
|
67,000 | 132,000 | ||||||
Accrued
accounting fees
|
131,000 | 115,000 | ||||||
Accrued
payroll
|
70,000 | 18,000 | ||||||
$ | 7,349,000 | $ | 5,587,000 |
71
9.
|
Commitments
and Contingencies
|
We have
contractual obligations to make payments on leases of office and manufacturing
space as follows:
Years
Ending December 31,
|
Operating
Leases
|
|||
2008
|
$ | 1,696,000 | ||
2009
|
1,626,000 | |||
2010
|
707,000 | |||
Total
|
$ | 4,029,000 |
On May
24, 2005, we entered into a lease for 91,000 square feet of space located at
3020 and 3030 Callan Road, San Diego, California. The majority of our
operations are located in this facility. The agreement bears monthly
rent at an initial rate of $1.15 per square foot, with annual increases of
3%. The lease term is 57 months, commencing on October 1, 2005 and
expiring on June 30, 2010. Payments for our Callan Road location
commenced in June 2006.
The lease
contains a provision whereby we could be required to remove some or all of the
leasehold improvements we have constructed at the end of the lease
term. We believe the costs that could be incurred pursuant to this
provision would be immaterial, and therefore we have not recorded a liability
for them as of December 31, 2007.
We also
lease 4,027 square feet of office space located at 9-3 Otsuka 2-chome,
Bunkyo-ku, Tokyo, Japan. The agreement bears rent at a rate of $4.38
per square foot, for a term of two years expiring on November 30,
2009.
Rent
expense, which includes common area maintenance, for the years ended December
31, 2007, 2006 and 2005 was $1,992,000, $2,397,000 and $1,632,000,
respectively.
We have
entered into agreements with various clinical research organizations for
pre-clinical and clinical development studies, which have provisions for
cancellation. Under the terms of these agreements, the vendors provide a variety
of services including conducting pre-clinical development research, enrolling
patients, recruiting patients, monitoring studies and data analysis. Payments
under these agreements typically include fees for services and reimbursement of
expenses. The timing of payments due under these agreements was estimated based
on current schedules of pre-clinical and clinical studies in
progress. As of December 31, 2007, we have pre-clinical research
study obligations of $196,000 (all of which are expected to be complete within a
year) and clinical research study obligations of $9,295,000 ($4,155,000 of
which are expected to be complete within a year).
We are
subject to various claims and contingencies related to legal
proceedings. Due to their nature, such legal proceedings involve
inherent uncertainties including, but not limited to, court rulings,
negotiations between affected parties and governmental
actions. Management assesses the probability of loss for such
contingencies and accrues a liability and/or discloses the relevant
circumstances, as appropriate. Management believes that any liability
to us that may arise as a result of currently pending legal proceedings will not
have a material adverse effect on our financial condition, liquidity, or results
of operations as a whole.
Refer to
note 10 for a discussion of our commitments and contingencies related to our
interactions with the University of California.
Refer to
note 4 for a discussion of our commitments and contingencies related to our
transactions with Olympus, including (a) our obligation to the Joint Venture in
future periods and (b) certain put and call rights embedded in the arrangements
with Olympus.
Refer to
note 6 for a discussion of our commitments and contingencies related to our
arrangements with MAST and Senko.
10.
|
License
Agreement
|
On
October 16, 2001, StemSource, Inc. entered into an exclusive worldwide license
agreement with the Regents of the University of California (“UC”), licensing all
of UC’s rights to certain pending patent applications being prosecuted by UC and
(in part) by the University of Pittsburgh, for the life of these
patents, with the right of sublicense. The exclusive license relates
to an issued patent (“Patent 6,777,231”) and various pending applications
relating to adipose derived stem cells. In November 2002, we acquired
StemSource, and the license agreement was assigned to us.
The
agreement, which was amended and restated in September 2006 to better reflect
our business model, calls for various periodic payments until such time as we
begin commercial sales of any products utilizing the licensed
technology. Upon achieving commercial sales of products or services
covered by the UC license agreement, we will be required to pay variable earned
royalties based on the net sales of products sold. Minimum royalty
amounts will increase annually with a plateau in 2015. In addition,
there are certain due diligence milestones that are required to be reached as a
result of the agreement. Failure to fulfill these milestones may
result in a reduction of or loss of the specific rights to which the effected
milestone relates.
72
In
connection with the amendment of the agreement in the third quarter of 2006, we
agreed to issue 100,000 shares of our common stock to UC in the fourth quarter
of 2006. At the time the agreement was reached, our shares were
trading at $4.87 per share. The expense was charged to general and
administrative expense.
Additionally,
we are obligated to reimburse UC for patent prosecution and other legal costs on
any patent applications contemplated by the agreement. In particular,
the University of Pittsburgh filed a lawsuit in the fourth quarter of 2004,
naming all of the inventors who had not assigned their ownership interest in
Patent 6,777,231 to the University of Pittsburgh. It was seeking a
determination that its assignors, rather than UC’s assignors, are the true
inventors of Patent 6,777,231. This lawsuit has subjected us to and
could continue to subject us to significant costs and, if the University of
Pittsburgh wins the lawsuit, our license rights to this patent could be
nullified or rendered non-exclusive with respect to any third party that might
license rights from the University of Pittsburgh.
On August
9, 2007, the United States District Court granted the University of Pittsburgh’s
motion for Summary Judgment in part, determining that the University of
Pittsburgh’s assignees were properly named as inventors on Patent 6,777,231, and
that all other inventorship issues shall be determined according to the facts
presented at trial. The trial was concluded in January 2008 and we
expect to have the trial court’s final decision on the case sometime in the
first or second quarter of 2008.
We are
not named as a party to the lawsuit, but our president, Marc Hedrick, is one of
the inventors identified on the patent and therefore is a named individual
defendant. We are providing substantial financial and other
assistance to the defense of the lawsuit.
In the
years ended December 31, 2007, 2006 and 2005, we expensed $2,418,000, $2,189,000
and $1,303,000, respectively, for legal fees related to this
license. These expenses have been classified as general and
administrative expense in the accompanying consolidated financial
statements. We believe that the $2,464,000 accrued as of December 31,
2007 is a reasonable estimate of our liability for the unpaid expenses incurred
through December 31, 2007.
11.
|
Long-term
Obligations
|
In 2003,
we entered into an Amended Master Security Agreement to provide financing for
new equipment purchases. In 2004, we issued promissory notes in an aggregate
principal amount of approximately $1,039,000 and in 2005, we issued one
additional promissory note for an amount of approximately $1,380,000. Our most
recent promissory note, with approximately $600,000 in principal, was executed
in December 2006. All outstanding notes are secured by equipment with
an aggregate cost of approximately $2,297,000.
Additional
details relating to the above promissory notes that are outstanding as of
December 31, 2007, are presented in the following table:
Origination Date
|
Original
Loan Amount
|
Interest
Rate
|
Current
Monthly
Payment*
|
Term
|
Remaining
Principal
|
||||||||||||
September
2004
|
$ | 317,000 | 8.97 | % | $ | 9,000 |
48
Months
|
$ | 20,000 | ||||||||
December
2005
|
1,380,000 | 10.75 | % | 42,000 |
36
Months
|
503,000 | |||||||||||
December
2006
|
600,000 | 11.05 | % | 20,000 |
36
Months
|
435,000 | |||||||||||
Total
|
958,000 | ||||||||||||||||
Less:
Current Portion
|
(721,000 | ) | |||||||||||||||
Long-Term
Obligations
|
$ | 237,000 |
________________________________________
* Includes
principal and interest
As of
December 31, 2007, the future contractual principal payments on all of our
promissory notes are as follows:
Years Ending December 31,
|
||||
2008
|
$ | 721,000 | ||
2009
|
221,000 | |||
2010
|
16,000 | |||
Total
|
$ | 958,000 |
Our
interest expense for the years ended December 31, 2007, 2006 and 2005 (all of
which related to promissory notes issued in connection with our Amended Master
Security Agreement) was $155,000, $199,000 and $137,000,
respectively.
73
12.
|
Income
Taxes
|
Due to
our net loss position for the years ended December 31, 2007, 2006 and 2005, and
since we have recorded a full valuation allowance against deferred tax assets,
there was no provision or benefit for income taxes recorded. There were no
components of current or deferred federal or state income tax provisions for the
years ended December 31, 2007, 2006, and 2005.
A
reconciliation of the total income tax provision tax rate to the statutory
federal income tax rate of 34% for the years ended December 31, 2007, 2006 and
2005 is as follows:
2007
|
2006
|
2005
|
||||||||||
Income
tax expense (benefit) at federal statutory rate
|
(34.00 | )% | (34.00 | )% | (34.00 | )% | ||||||
Stock
based
compensation
|
0.92 | % | 0.99 | % | 0.05 | % | ||||||
Credits
|
(4.87 | )% | (2.72 | )% | (0.59 | )% | ||||||
Change
in federal valuation
allowance
|
41.62 | % | 34.52 | % | 23.46 | % | ||||||
Equity
loss on investment in Joint Venture
|
0.01 | % | 0.12 | % | 5.35 | |||||||
Gain
on intangible
property
|
— | % | — | % | 4.74 | |||||||
Other,
net
|
(3.68 | )% | 1.09 | % | 0.99 | % | ||||||
0.00 | % | 0.00 | % | 0.00 | % |
The tax
effects of temporary differences that give rise to significant portions of the
deferred tax assets and deferred tax liabilities as of December 31, 2007 and
2006 are as follows:
2007
|
2006
|
|||||||
Deferred
tax assets:
|
||||||||
Allowances
and
reserves
|
$ | 55,000 | $ | 163,000 | ||||
Accrued
expenses
|
582,000 | 625,000 | ||||||
Deferred
revenue and gain on sale of
assets
|
5,910,000 | 7,971,000 | ||||||
Stock
based
compensation
|
2,528,000 | 1,933,000 | ||||||
Net
operating loss
carryforwards
|
37,704,000 | 24,410,000 | ||||||
Income
tax credit
carryforwards
|
4,140,000 | 3,201,000 | ||||||
Capitalized
assets and
other
|
284,000 | 720,000 | ||||||
51,203,000 | 39,023,000 | |||||||
Valuation
allowance
|
(50,435,000 | ) | (38,505,000 | ) | ||||
Total
deferred tax assets, net of
allowance
|
768,000 | 518,000 | ||||||
Deferred
tax liabilities:
|
||||||||
Property
and equipment, principally due to differences in
depreciation
|
(338,000 | ) | — | |||||
Intangibles
|
(430,000 | ) | (518,000 | ) | ||||
Other
|
— | — | ||||||
Total
deferred tax
liability
|
(768,000 | ) | (518,000 | ) | ||||
Net
deferred tax assets
(liability)
|
$ | — | $ | — |
We have
established a valuation allowance against our net deferred tax asset due to the
uncertainty surrounding the realization of such assets. Management periodically
evaluates the recoverability of the deferred tax asset. At such time as it is
determined that it is more likely than not that deferred assets are realizable,
the valuation allowance will be reduced. We have recorded a valuation allowance
of $50,435,000 as of December 31, 2007 to reflect the estimated amount of
deferred tax assets that may not be realized. We increased our valuation
allowance by approximately $11,930,000 for the year ended December 31, 2007. The
valuation allowance includes approximately $579,000 related to stock option
deductions, the benefit of which will be credited to equity if ever
utilized.
At
December 31, 2007, we had federal and state tax net operating loss carryforwards
of approximately $89,941,000 and $77,254,000, respectively. The federal and
state net operating loss carryforwards begin to expire in 2019 and 2013,
respectively, if unused. At December 31, 2007, we had federal and state tax
credit carryforwards of approximately $2,946,000 and $2,735,000, respectively.
The federal credits will begin to expire in 2017, if unused, and $160,000 of the
state credits will begin to expire in 2009 if unused. The remaining state
credits carry forward indefinitely. In addition, we had foreign tax
loss carryforwards of $2,774,000 and $179,000 in Japan and the United Kingdom,
respectively.
The
Internal Revenue Code limits the future availability of net operating loss and
tax credit carryforwards that arose prior to certain cumulative changes in a
corporation’s ownership resulting in a change of our control. Due to prior
ownership changes as defined in IRC Section 382, a portion of the net operating
loss and tax credit carryforwards are limited in their annual utilization. In
September 1999, we experienced an ownership change for purposes of the IRC
Section 382 limitation. As of December 31, 2007, these pre-change net operating
losses and credits are fully available.
74
Additionally,
in 2002 when we purchased StemSource, we acquired federal and state net
operating loss carryforwards of approximately $2,700,000 and $2,700,000,
respectively. This event triggered an ownership change for purposes of IRC
Section 382. It is estimated that the pre-change net operating losses and
credits will be fully available by 2008.
We have
completed an update to our IRC Section 382 study analysis through April 17,
2007. We have not had any additional ownership changes based on this
study.
As a
result of the adoption of SFAS 123R, we recognize windfall tax benefits
associated with the exercise of stock options directly to stockholders’ equity
only when realized. Accordingly, deferred tax assets are not
recognized for net operating loss carryforwards resulting from windfall tax
benefits occurring from January 1, 2006 onward. At December 31, 2007,
deferred tax assets do not include $2,026,000 of excess tax benefits from
stock-based compensation.
In July
2006, the FASB issued Interpretation No. 48, Accounting for Uncertainty in
Income Taxes – An Interpretation of FASB Statement No. 109 (“FIN 48”) which is
effective for fiscal years beginning after December 15, 2006 and was first
effective for the Company beginning January 1, 2007. FIN 48 clarifies
the accounting for uncertainty in income taxes recognized in an entity’s
financial statements in accordance with FASB Statement No. 109, Accounting for
Income Taxes, and prescribes a recognition threshold and measurement attributes
for financial statement disclosure of tax positions taken or expected to be
taken on a tax return. Under FIN 48, the impact of an uncertain
income tax position on the income tax return must be recognized at the largest
amount that is more-likely-than-not to be sustained upon audit by the relevant
taxing authority. An uncertain income tax position will not be
recognized if it has less than a 50% likelihood of being
sustained. Additionally, FIN 48 provides guidance on de-recognition,
classification, interest and penalties, accounting in interim periods,
disclosure and transition.
The total
amount of unrecognized tax benefits as of the date of adoption was
zero.
Following
is a tabular reconciliation of the Unrecognized Tax Benefits activity during
2007:
Unrecognized
Tax Benefits – Opening Balance
|
None
|
|||
Gross
increases – tax positions in prior period
|
None
|
|||
Gross decreases – tax positions in prior period |
None
|
|||
Gross
increase – current-period tax positions
|
$ | 716,545 | ||
Settlements
|
None
|
|||
Lapse
of statute of limitations
|
None
|
|||
Unrecognized
Tax Benefits – Ending Balance
|
$ | 716,545 |
None of
the amount included in the FIN 48 liability if recognized would affect the
Company’s effective tax rate, since it would be offset by an equal reduction in
the deferred tax asset valuation allowance. The Company’s deferred
tax assets are fully reserved.
The
Company did not recognize interest related to unrecognized tax benefits in
interest expense and penalties in operating expenses as of December 31,
2007.
The
Company is subject to taxation in the United States and
California. The Company is currently not under examination by the
Internal Revenue Service or any other taxing authority.
The
Company’s tax years for 1999 and forward can be subject to examination by the
United States and California tax authorities due to the carryforward of net
operating losses and research development credits.
The
Company does not foresee material changes to its gross FIN 48 liability within
the next twelve months.
13.
|
Employee
Benefit Plan
|
We
implemented a 401(k) retirement savings and profit sharing plan (the “Plan”)
effective January 1, 1999. We may make discretionary annual contributions to the
Plan, which is allocated to the profit sharing accounts based on the number of
years of employee service and compensation. At the sole discretion of the Board
of Directors, we may also match the participants’ contributions to the Plan. We
made no discretionary or matching contributions to the Plan in 2007, 2006 or
2005.
75
14.
|
Stockholders’
Deficit
|
Preferred
Stock
We have
authorized 5,000,000 shares of $.001 par value preferred stock, with no shares
outstanding as of December 31, 2007 and 2006. Our Board of Directors is
authorized to designate the terms and conditions of any preferred stock we issue
without further action by the common stockholders.
Common
Stock
In February
2007, we completed a registered direct public offering of units consisting of
common stock and warrants. We received net proceeds of $19,901,000 from
the sale of units consisting of 3,746,000 shares of common stock and 1,873,000
common stock warrants (with an exercise price of $6.25 per share and a five-year
exercisability period) under our shelf registration statement.
We have
accounted for the warrants as permanent equity, consistent with EITF 00-19,
“Accounting for Derivative Financial Instruments Indexed to, and Potentially
Settled in, a Company’s Own Stock”. The warrants must be settled through a
cash exercise whereby the warrant holder exchanges cash for shares of Cytori
common stock, unless the exercise occurs when the related registration statement
is not effective, in which case the warrant holder can only exercise through the
cashless exercise feature of the warrant agreement.
Treasury Stock
Treasury Stock
On August
11, 2003, the Board of Directors authorized the repurchase of up to 3,000,000
shares of our common stock in the open market, from time to time until August
10, 2004 at a purchase price per share not to exceed €15.00, based on the
exchange rate in effect on August 11, 2003. During 2003, we repurchased 614,099
shares of our Common Stock at an average cost of $3.69 per share for a total of
$2,266,000.
In 2003,
we sold 150,500 shares of treasury stock for $542,000 at an average price of
$3.60 per share. The basis of the treasury stock sold was the weighted average
purchase price or $3.67 per share with the difference of $10,000 accounted for
as a reduction to additional paid-in capital.
On December 6, 2003, we
exchanged 1,447,755 shares of common stock (all listed on the Frankfurt Stock
Exchange) held in our treasury for 1,447,755 of our unlisted outstanding common
stock issued to former StemSource shareholders. $104,000 was accounted
for as a charge against additional paid-in capital relating to the difference
between the weighted average purchase price and fair market value of the listed
shares held in treasury at the time of the exchange.
In 2004,
we repurchased 27,650 shares of our common stock for $76,000 on the open market
at a price of $2.75 per share. Additionally in 2004, we repurchased 262,602
shares of our common stock for $976,000 from a former director and officer of
StemSource at a price of $3.72 per share.
Our
repurchase program expired on August 10, 2004. We have no plans to initiate a
new repurchase program at this time.
In April
2007, we sold 1,000,000 shares of unregistered common stock from our treasury to
Green Hospital Supply, Inc. for $6,000,000 cash, or $6.00 per
share. The basis of the treasury stock sold was the weighted average
purchase price, or $3.62 per share, and the difference of $2.38 per share, or
$2,380,000, was accounted for as an increase to additional paid-in
capital.
15.
|
Stockholders
Rights Plan
|
On May
28, 2003, the Board of Directors declared a dividend distribution of one
preferred share purchase right (a “Right”) for each outstanding share of our
common stock. The dividend is payable to the stockholders of record on June 10,
2003, and with respect to shares of common stock issued thereafter until the
Distribution Date (as defined below) and, in certain circumstances, with respect
to shares of common stock issued after the Distribution Date. Except as set
forth below, each Right, when it becomes exercisable, entitles the registered
holder to purchase from us one one-thousandth (1/1000th) of a share of our
Series RP Preferred Stock, $0.001 par value per share (the “Preferred Stock”),
at a price of $25.00 per one one-thousandth (1/1000th) of a share of Preferred
Stock, subject to adjustment. Each share of the Preferred Stock would entitle
the holder to our common stock with a value of twice that paid for the Preferred
Stock. The description and terms of the Rights are set forth in a Rights
Agreement (the “Rights Agreement”) between us and Computershare Trust Company,
Inc., as Rights Agent, dated as of May 29, 2003, and as amended on May 12, 2005
and August 28, 2007.
76
The
Rights attach to all certificates representing shares of our common stock
outstanding, and are evidenced by a legend on each share certificate,
incorporating the Rights Agreement by reference. The Rights trade with and only
with the associated shares of our common stock and have no impact on the way in
which holders can trade our shares. Unless the Rights Agreement was to be
triggered, it would have no effect on the Company’s consolidated balance sheet
or income statement and should have no tax effect on the Company or its
stockholders. The Rights Agreement is triggered upon the earlier to occur of (i)
a person or group of affiliated or associated persons having acquired, without
the prior approval of the Board, beneficial ownership of 15% or more of the
outstanding shares of our common stock or (ii) 10 days, or such later date as
the Board may determine, following the commencement of or announcement of an
intention to make, a tender offer or exchange offer the consummation of which
would result in a person or group of affiliated or associated persons becoming
an Acquiring Person (as defined in the Rights Agreement) except in certain
circumstances (the “Distribution Date”). The Rights are not exercisable until
the Distribution Date and will expire at the close of business on May 29, 2013,
unless we redeem them earlier.
|
16.
Stock-based Compensation
|
During
2004, we adopted the 2004 Equity Incentive Plan (the “2004 Plan”), which
provides our employees, directors and consultants the opportunity to purchase
our common stock through non-qualified stock options, stock appreciation rights,
restricted stock units, or restricted stock and cash awards. The 2004
Plan initially provides for issuance of 3,000,000 shares of our common stock,
which number may be cumulatively increased (subject to Board discretion) on an
annual basis beginning January 1, 2005, which annual increase shall not exceed
2% of our then outstanding stock. As of December 31, 2007, there are
2,129,146 securities remaining and available for future issuances under 2004
Plan, which is exclusive of securities to be issued upon an exercise of
outstanding options, warrants, and rights.
During
1997, we adopted the 1997 Stock Option and Stock Purchase Plan (the “1997
Plan”), which provides for the direct award or sale of shares and for the grant
of incentive stock options (“ISOs”) and non-statutory options to employees,
directors or consultants. The 1997 Plan, as amended, provides for the
issuance of up to 7,000,000 shares of our common stock. The exercise
price of ISOs cannot be less than the fair market value of the underlying shares
on the date of grant. ISOs can be granted only to employees. The 1997
Plan expired on October 22, 2007.
Generally,
awards issued under the 2004 Plan or the 1997 Plan are subject to four-year
vesting, and have a contractual term of 10 years. Most awards contain
one of the following two vesting provisions:
·
|
12/48
of a granted award will vest after one year of service, while an
additional 1/48 of the award will vest at the end of each month thereafter
for 36 months, or
|
·
|
1/48
of the award will vest at the end of each month over a four-year
period.
|
A summary
of activity for the year ended December 31, 2007 is as follows:
Options
|
Weighted
Average Exercise Price
|
|||||||
Balance
as of January 1, 2007
|
5,934,029 | $ | 4.62 | |||||
Granted
|
912,903 | 5.53 | ||||||
Exercised
|
(604,334 | ) | 3.08 | |||||
Expired
|
(134,459 | ) | 6.40 | |||||
Cancelled/forfeited
|
(100,864 | ) | 6.09 | |||||
Balance
as of December 31, 2007
|
6,007,275 | $ | 4.85 |
Options
|
Weighted
Average Exercise Price
|
Weighted
Average Remaining Contractual Term (years)
|
Aggregate
Intrinsic Value
|
|||||||||||||
Balance
as of December 31, 2007
|
6,007,275 | $ | 4.85 | 5.77 | $ | 9,470,831 | ||||||||||
Vested
and unvested expected to vest at December 31, 2007
|
5,867,357 | $ | 4.83 | 5.70 | $ | 9,365,318 | ||||||||||
Vested
and exercisable at December 31, 2007
|
4,453,825 | $ | 4.57 | 4.79 | $ | 8,299,362 |
77
The
following table summarizes information about options outstanding as of December
31, 2007:
Options
Outstanding
|
Options
Exercisable
|
|||||||||||||||||||||
Range of Exercise Price
|
Number
of Shares
|
Weighted
Average
Exercise
Price
|
Weighted
Average
Remaining
Contractual Life
in Years
|
Number
of Shares
|
Weighted
Average
Exercise
Price
|
|||||||||||||||||
Less
than $2.00
|
223,908 | $ | 0.35 | 1.0 | 223,908 | $ | 0.35 | |||||||||||||||
$2.00 – 3.99 | 1,623,159 | 3.07 | 4.6 | 1,440,392 | 3.07 | |||||||||||||||||
$4.00 – 5.99 | 2,451,657 | 4.69 | 6.9 | 1,645,014 | 4.40 | |||||||||||||||||
$6.00 – 7.99 | 1,379,394 | 6.81 | 5.7 | 949,210 | 6.92 | |||||||||||||||||
$8.00 – 9.99 | 252,157 | 8.68 | 7.8 | 118,301 | 8.67 | |||||||||||||||||
More
than $10.00
|
77,000 | 13.18 | 2.2 | 77,000 | 13.18 | |||||||||||||||||
6,007,275 | 4,453,825 |
The total
intrinsic value of stock options exercised was $1,758,000, $1,913,000 and
$1,049,000 for the years ended December 31, 2007, 2006 and 2005,
respectively.
The fair
value of each option awarded during the year ended December 31, 2007, 2006, and
2005 was estimated on the date of grant using the Black-Scholes-Merton option
valuation model based on the following weighted-average
assumptions:
For
the years ended December 31,
|
||||||||||||
2007
|
2006
|
2005
|
||||||||||
Expected
term
|
6
years
|
6
years
|
8
years
|
|||||||||
Risk-free
interest rate
|
4.59 | % | 4.50 | % | 4.02 | % | ||||||
Volatility
|
74.61 | % | 78.61 | % | 80.00 | % | ||||||
Dividends
|
— | — | — | |||||||||
Resulting
weighted average grant date fair value
|
$ | 3.74 | $ | 5.26 | $ | 3.25 |
The
expected term assumption was estimated using the “simplified method,” as
described in Staff Accounting Bulletin No. 107, “Share-Based Payment” (“SAB
107”). This method estimates the expected term of an option based on
the average of the vesting period and the contractual term of an option
award.
The
expected volatility assumption is based on the historical volatility of our
common stock since the first day we became publicly traded (August
2000).
The
weighted average risk-free interest rate represents the interest rate for
treasury constant maturity instruments published by the Federal Reserve Board.
If the term of available treasury constant maturity instruments is not equal to
the expected term of an employee option, we use the weighted average of the two
Federal Reserve securities closest to the expected term of the employee
option.
The
dividend yield has been assumed to be zero as we (a) have never declared or paid
any dividends and (b) do not currently anticipate paying any cash dividends on
our outstanding shares of common stock in the foreseeable future.
The
following summarizes the total compensation cost recognized in the accompanying
financial statements:
For
the years ended December 31,
|
||||||||||||
2007
|
2006
|
2005
|
||||||||||
Total
compensation cost for share-based payment arrangements recognized in the
statement of operations (net of tax of $0)
|
$ | 2,310,000 | $ | 3,220,000 | $ | 404,000 |
As of
December 31, 2007, the total compensation cost related to non-vested stock
options not yet recognized for all of our plans is approximately $4,623,000.
These costs are expected to be recognized over a weighted average period of 1.86
years.
In
calculating the fair value of option awards granted after January 1, 2006, we
generally used the same methodologies and assumptions employed prior to our
adoption of SFAS 123R. For instance, our estimate of expected
volatility is based exclusively on our historical volatility, since we have
granted options that vest purely based on the passage of time and otherwise meet
the criteria to exclusively rely on historical volatility, as set out in SAB
107. We did, however, change our policy of attributing the cost of
share-based payment awards granted after January 1, 2006 from the “graded
vesting approach” to the “straight-line” method. We believe that this change
more accurately reflects the manner in which our employees vest in an option
award.
78
Cash
received from stock option and warrant exercises for the years ended December
31, 2007, 2006 and 2005 was approximately $1,875,000, $920,000, and $224,000,
respectively. SFAS 123R requires that cash flows resulting from
tax deductions in excess of the cumulative compensation cost recognized for
options exercised (excess tax benefits) be classified as cash inflows provided
by financing activities and cash outflows used in operating
activities. No income tax benefits have been recorded related to the
stock option exercises. SFAS 123R prohibits recognition of tax
benefits for exercised stock options until such benefits are
realized. As we presently have tax loss carryforwards from prior
periods and expect to incur tax losses in 2007, we are not able to benefit from
the deduction for exercised stock options in the current reporting
period.
In
November 2005, the FASB issued Staff Position (FSP) No. FAS 123(R)-3,
“Transition Election Related to Accounting for Tax Effects of Share-Based
Payment Awards” (FSP 123R-3). We have elected to adopt the alternative
transition method provided in the FSP 123R-3 for calculating the tax effects of
stock-based compensation pursuant to SFAS 123R. The alternative transition
method includes simplified methods to establish the beginning balance of the
APIC pool related to the tax effects of employee stock-based compensation, and
to determine the subsequent impact on the APIC pool and Consolidated Statements
of Cash Flows of the tax effects of employee stock-based compensation awards
that are outstanding upon adoption of SFAS 123R.
To settle
stock option awards that have been exercised, we will issue new shares of our
common stock. At December 31, 2007, we have an aggregate
of 70,910,612 shares authorized and available to satisfy option
exercises under our plans.
Cash used
to settle equity instruments granted under share-based payment arrangements
amounted to $0 in all periods presented.
Award
Modifications
On August
2, 2007, our Senior Vice President – Research - Regenerative Cell Technology
(“VP”) terminated employment with us. We paid the former VP a lump
sum cash severance payment of $66,667 and extended the exercise period of his
35,000 vested stock options through December 31, 2007. In addition to
the cash severance payment, we recorded stock based compensation expense of
$5,741 in the third quarter of 2007, which reflects the incremental fair value
of the extended vested stock options (over the fair value of the original awards
at the modification date).
In
connection with the sale of our HYDROSORB™ spine and orthopedics surgical
implant product line, we eliminated the positions of two less senior employees
on August 31, 2007. At the time these positions were eliminated, we
(a) accelerated the vesting of 2,084 unvested stock options held by these two
employees, and (b) extended the exercise period of 37,292 vested stock options
owned by them through December 31, 2008. 16,041 unvested stock
options held by these two employees were forfeited.
In
connection with the above modifications and in accordance with SFAS 123R, we
recorded additional stock based compensation expense of $58,402 in the year
ended December 31, 2007, as a component of general and
administrative. This charge constitutes the entire expense related to
the modification of these options, and no future period charges will be
required.
Marshall
G. Cox retired from our board of directors (and his employment by the Company
thereby ceased) on May 3, 2007. We subsequently entered into a
consulting agreement with Mr. Cox whereby he will continue to provide services
to the Company through March 1, 2009. Subject to his continued
service to the Company, all of Mr. Cox’s outstanding stock options previously
granted to him in his capacity as a director will continue to vest and be
exercisable, in accordance with their original terms. As of May 3,
2007, Mr. Cox held a total of 91,250 unvested stock options. After
May 3, 2007, the fair value of Mr. Cox’s unvested stock options will be
remeasured each reporting period until they fully vest. There was no
additional stock based compensation expense recorded as a result of the
modification of Mr. Cox’s options.
In May
2006, our Senior Vice President of Finance and Administration, Treasurer, and
Principal Accounting Officer terminated full-time employment with
us. In connection with his full-time employment termination, we
extended the exercise period of his 204,997 vested stock options as of May 31,
2006 to December 31, 2007. Moreover, we entered into a part-time
employment agreement with him according to which all stock option vesting ceased
as of May 31, 2006, resulting in the cancellation of 75,003 non-vested stock
options on May 31, 2006.
In
connection with a broader reduction in force, we eliminated the positions of our
Senior Vice President, Business Development, and Vice President, Marketing &
Development, on July 25, 2006. We subsequently entered into
short-term employment agreements with the individuals formerly holding these
positions. These individuals continued to provide service to us
following the elimination of their former positions on July 25,
2006. At the time these positions were eliminated, 142,686 non-vested
stock options held by these two employees were forfeited. Moreover,
subject to certain restrictions, we extended the exercise period for 328,564
vested stock options held by these employees to December 31, 2007.
We also
eliminated the position of a less senior employee on July 31,
2006. Simultaneously, we continued the individual’s employment in a
new capacity; however, we cancelled 8,125 non-vested stock options held by this
individual on July 31, 2006.
79
In
connection with the above modifications and in accordance with SFAS 123R, we
recorded additional expense of $567,000 in the year ended December 31, 2006,
respectively, as components of research and development, general and
administrative and sales and marketing expense. This charge
constitutes the entire expense related to these options, and no future period
charges will be required.
In August
2005, our Chief Operating Officer (“COO”), ceased employment with
us. We paid the former COO a lump sum cash severance payment of
$155,164 and extended the post-separation exercise period for two years on
253,743 vested stock options. In addition to the cash severance
payment, we recorded stock based compensation expense of $337,000 in the third
quarter of 2005, which represents the intrinsic value of the options held by the
COO at the date of the modification.
Non-Employee
Stock Based Compensation
In the
fourth quarter of 2007, we granted an option to purchase 22,500 shares of our
common stock to a non-employee scientific advisor. The stock option
has a contractual term of 10 years and will vest in annual installments of 7,500
shares each on May 31, 2008, 2009 and 2010, subject to the individual’s
continued service to the Company. This scientific advisor will also
be receiving cash consideration as services are performed. We will
remeasure the fair value of this advisor’s unvested stock options each reporting
period until they fully vest, and the resulting stock based compensation expense
will be recorded as a component of research and development
expenses.
In the
first quarter of 2006, we granted 2,500 shares of restricted common stock to a
non-employee scientific advisor. Because the shares granted are not subject to
additional future vesting or service requirements, the stock based compensation
expense of approximately $18,000 recorded in the first quarter of 2006
constitutes the entire expense related to this award, and no future period
charges will be required. The stock is restricted only in that it cannot be sold
for a specified period of time. There are no vesting requirements. This
scientific advisor will also be receiving cash consideration as services are
performed. The fair value of the stock granted was $7.04 per share based on the
market price of our common stock on the date of grant. There were no
discounts applied for the effects of the restriction, since the value of the
restriction is considered to be de minimis. The entire charge of
$18,000 was reported as a component of research and development
expenses.
In the
second quarter of 2005, we granted 20,000 shares of restricted common stock to a
non-employee scientific advisor. Because the shares granted are not
subject to additional future vesting or service requirements, the stock based
compensation expense of approximately $63,000 recorded in the second quarter of
2005 as a component of research and development expense constitutes the entire
expense related to this grant, and no future period charges will be
required. The fair value of the stock granted was $3.15 per share
based on the market price of our common stock on the date of
grant. The stock is restricted only in that it cannot be sold for a
specified period of time. There are no vesting
requirements. This scientific advisor will also be receiving cash
consideration as services are performed.
17.
|
Related
Party Transactions
|
Refer to
note 4 for a discussion of related party transactions with Olympus.
80
|
18.
Quarterly Information (unaudited)
|
The
following unaudited quarterly financial information includes, in management’s
opinion, all the normal and recurring adjustments necessary to fairly state the
results of operations and related information for the periods
presented.
For the three months ended
|
||||||||||||||||
March 31,
2007
|
June 30,
2007
|
September 30,
2007
|
December 31,
2007
|
|||||||||||||
Product
revenues
|
$ | 280,000 | $ | 512,000 | $ | — | $ | — | ||||||||
Gross
profit
|
55,000 | 315,000 | — | — | ||||||||||||
Development
revenues
|
45,000 | 1,814,000 | 3,373,000 | 25,000 | ||||||||||||
Operating
expenses
|
8,908,000 | 8,245,000 | 8,983,000 | 10,841,000 | ||||||||||||
Other
income
|
139,000 | 2,120,000 | 282,000 | 137,000 | ||||||||||||
Net
loss
|
$ | (8,669,000 | ) | $ | (3,996,000 | ) | $ | (5,328,000 | ) | $ | (10,679,000 | ) | ||||
Basic
and diluted net loss per share
|
$ | (0.43 | ) | $ | (0.17 | ) | $ | (0.22 | ) | $ | (0.44 | ) |
For the three months ended
|
||||||||||||||||
March 31,
2006
|
June 30,
2006
|
September 30,
2006
|
December 31,
2006
|
|||||||||||||
Product
revenues
|
$ | 502,000 | $ | 453,000 | $ | 133,000 | $ | 363,000 | ||||||||
Gross
profit (loss)
|
48,000 | (51,000 | ) | (250,000 | ) | 70,000 | ||||||||||
Development
revenues
|
830,000 | 63,000 | 351,000 | 5,232,000 | ||||||||||||
Operating
expenses
|
8,418,000 | 7,437,000 | 8,969,000 | 7,324,000 | ||||||||||||
Other
income
|
84,000 | 112,000 | 101,000 | 111,000 | ||||||||||||
Net
loss
|
$ | (7,456,000 | ) | $ | (7,313,000 | ) | $ | (8,767,000 | ) | $ | (1,911,000 | ) | ||||
Basic
and diluted net loss per share
|
$ | (0.48 | ) | $ | (0.47 | ) | $ | (0.53 | ) | $ | (0.10 | ) |
19.
Subsequent Events
On
February 8, 2008, we agreed to sell 2,000,000 shares of unregistered common
stock to Green Hospital Supply, Inc. for $12,000,000 cash, or $6.00 per share in
a private stock placement. On February 29, 2008 we closed the first
half of the private placement with Green Hospital Supply, Inc. and received
$6,000,000. We have agreed to close the second half of the private placement on
or before April 30, 2008.
Item 9. Changes in and Disagreements with Accountants on
Accounting and Financial Disclosure
Not
applicable.
Item 9A. Controls and Procedures
Evaluation
of Disclosure Controls and Procedures
We
maintain disclosure controls and procedures that are designed to ensure that
information required to be disclosed in our reports filed or furnished pursuant
to the Exchange Act is recorded, processed, summarized and reported within the
time periods specified in the Securities and Exchange Commission’s rules and
forms, and that such information is accumulated and communicated to our
management, including our Chief Executive Officer and Chief Financial Officer,
as appropriate, to allow for timely decisions regarding required
disclosure. In designing and evaluating the disclosure controls and
procedures, management recognizes that any controls and procedures, no matter
how well designed and operated, can provide only reasonable assurance of
achieving the desired control objectives, and management necessarily is required
to apply its judgment in evaluating the cost-benefit relationship of possible
controls and procedures.
As
required by Rule 13a-15(b) under the Exchange Act, we carried out an evaluation,
under the supervision and with the participation of our management, including
our Chief Executive Officer and Chief Financial Officer, of the effectiveness of
the design and operation of our disclosure controls and procedures as of the end
of the period covered by this Annual Report of Form 10-K. Based on
the foregoing, our Chief Executive Officer and Chief Financial Officer concluded
that our disclosure controls and procedures were effective and were operating at
a reasonable assurance level as of December 31, 2007.
81
Management’s
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). Under the supervision and with the participation of our
management, including our Chief Executive Officer and Chief Financial Officer,
we have conducted an evaluation of the effectiveness of our internal control
over financial reporting based on the framework in Internal Control - Integrated
Framework issued by the Committee of Sponsoring Organizations of the Treadway
Commission. 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. Based on our evaluation under the framework in Internal
Control - Integrated Framework, our management concluded that our internal
control over financial reporting was effective as of December 31,
2007.
The
effectiveness of our internal control over financial reporting as of December
31, 2007 has been audited by KPMG LLP, an independent registered public
accounting firm, as stated in their report which is included
herein.
Changes
in Internal Control over Financial Reporting
There
has been no change in our internal control over financial reporting during the
quarter ended December 31, 2007 that have materially affected, or are reasonably
likely to materially affect, our internal control over financial
reporting.
Item 9B. Other Information
None
82
PART
III
Item 10. Directors, Executive Officers and Corporate
Governance
The
information called for by Item 10 is incorporated herein by reference to the
material under the captions “Election of Directors” and “Directors, Executive
Officers and Corporate Governance” in our proxy statement for our 2008 annual
stockholders’ meeting, which will be filed with the SEC on or before April 29,
2008.
Item 11. Executive Compensation
The
information called for by Item 11 is incorporated herein by reference to the
material under the caption “Executive Compensation” in our proxy statement for
our 2008 annual stockholders’ meeting, which will be filed with the SEC on or
before April 29, 2008.
Item 12. Security Ownership of Certain Beneficial Owners and
Management and Related Stockholder Matters
The
information called for by Item 12 is incorporated herein by reference to the
material under the caption “Security Ownership of Certain Beneficial Owners and
Management” in our proxy statement for our 2008 annual stockholders’ meeting,
which will be filed with the SEC on or before April 29, 2008.
Item 13. Certain Relationships and Related Transactions, and
Director Independence
The
information called for by Item 13 is incorporated herein by reference to the
material under the caption “Information Concerning Directors and Executive
Officers- Certain Relationships and Related Transactions” in our proxy statement
for our 2008 annual stockholders’ meeting, which will be filed with the SEC on
or before April 29, 2008.
Item 14. Principal Accountant Fees and Services
The
information called for by Item 14 is incorporated herein by reference to the
material under the caption “Principal Accountant Fees and Services” in our proxy
statement for our 2008 annual stockholders meeting, which will be filed with the
SEC on or before April 29, 2008.
83
PART
IV
Item 15. Exhibits, Financial Statement Schedules
(a)
(1)
|
Financial
Statements
|
||
|
|||
|
|||
|
|||
|
|||
|
|||
|
(a)
(2) Financial
Statement Schedules
SCHEDULE
II — VALUATION AND QUALIFYING ACCOUNTS
For the
years ended December 31, 2007, 2006 and 2005
(in
thousands of dollars)
Balance at
beginning of
year
|
Additions/(Reductions)
((charges)/ credits to
expense)
|
Charged to
Other
Accounts
|
Deductions
|
Balance at
end of year
|
||||||||||||||||
Allowance for doubtful
accounts
|
||||||||||||||||||||
Year
ended December 31, 2007
|
$ | 2 | $ | 1 | $ | — | $ | (2 | ) | $ | 1 | |||||||||
Year
ended December 31, 2006
|
$ | 9 | $ | — | $ | — | $ | (7 | ) | $ | 2 | |||||||||
Year
ended December 31, 2005
|
$ | 8 | $ | 1 | $ | — | $ | — | $ | 9 |
84
Table
of Contents
(a)(3) Exhibits
Exhibit
Number
|
Description
|
|
2.5
|
Asset
Purchase Agreement dated May 30, 2007, by and
between Cytori Therapeutics, Inc. and MacroPore Acquisition Sub, Inc
(filed as Exhibit 2.5 to our Form 10-Q Quarterly Report as
filed on August 14, 2007 and incorporated by reference
herein)
|
|
3.1
|
Amended
and Restated Certificate of Incorporation (filed as Exhibit 3.1
to our Form 10-Q Quarterly Report as filed on August 13, 2002 and
incorporated by reference herein)
|
|
3.2
|
Amended
and Restated Bylaws of Cytori Therapeutics, Inc. (filed as
Exhibit 3.2 to our Form 10-Q Quarterly Report, as filed on
August 14, 2003 and incorporated by reference herein)
|
|
3.3
|
Certificate
of Ownership and Merger (effecting name change to Cytori Therapeutics,
Inc.) (filed as Exhibit 3.1.1 to our Form 10-Q, as filed on November 14,
2005 and incorporated by reference herein)
|
|
4.1
|
Rights
Agreement, dated as of May 19, 2003, between Cytori Therapeutics, Inc. and
Computershare Trust Company, Inc. as Rights Agent, which includes: as
Exhibit A thereto, the Form of Certificate of Designation, Preferences and
Rights of Series RP Preferred Stock of Cytori Therapeutics, Inc.; as
Exhibit B thereto, the Form of Right Certificate; and, as Exhibit C
thereto, the Summary of Rights to Purchase Series RP Preferred Stock
(filed as Exhibit 4.1 to our Form 8-A which was filed on May 30, 2003 and
incorporated by reference herein)
|
|
4.1.1
|
Amendment
No. 1 to Rights Agreement dated as of May 12, 2005, between Cytori
Therapeutics, Inc. and Computershare Trust Company, Inc. as Rights Agent
(filed as Exhibit 4.1.1 to our Form 8-K, which was filed on May 18, 2005
and incorporated by reference herein).
|
|
4.1.2
|
Amendment
No. 2 to Rights Agreement, dated as of August 28, 2007, between us and
Computershare Trust Company, N.A. (as successor to Computershare Trust
Company, Inc.), as Rights Agent (filed as Exhibit 4.1.1 to our Form 8-K,
which was filed on September 4, 2007 and incorporated by reference
herein).
|
|
10.1#
|
Amended
and Restated 1997 Stock Option and Stock Purchase Plan (filed as
Exhibit 10.1 to our Form 10 registration statement, as amended,
as filed on March 30, 2001 and incorporated by reference
herein)
|
|
10.1.1#
|
Board
of Directors resolution adopted November 9, 2006 regarding determination
of fair market value for stock option grant purposes (incorporated by
reference to Exhibit 10.10.1 filed
as exhibit 10.10.1 to our Form 10-K Annual Report, as filed on March 30,
2007 and incorporated by reference herein)
|
|
10.2+
|
Development
and Supply Agreement, made and entered into as of January 5, 2000, by
and between the Company and Medtronic (filed as Exhibit 10.4 to our
Form 10 registration statement, as amended, as filed on June 1,
2001 and incorporated by reference herein)
|
|
10.3+
|
Amendment
No. 1 to Development and Supply Agreement, effective as of
December 22, 2000, by and between the Company and Medtronic (filed as
Exhibit 10.5 to our Form 10 registration statement, as amended,
as filed on June 1, 2001 and incorporated by reference
herein)
|
|
10.4+
|
License
Agreement, effective as of October 8, 2002, by and between the Company and
Medtronic PS Medical, Inc. (filed as Exhibit 2.2 to our Current
Report on Form 8-K which was filed on October 23, 2002 and
incorporated by reference herein)
|
|
10.5+
|
Amendment
No. 2 to Development and Supply Agreement, effective as of September
30, 2002, by and between the Company and Medtronic, Inc. (filed as
Exhibit 2.4 to our Current Report on Form 8-K which was filed on
October 23, 2002 and incorporated by reference herein)
|
|
10.7
|
Amended
Master Security Agreement between the Company and General Electric
Corporation, September, 2003 (filed as Exhibit 10.1 to our
Form 10-Q Quarterly Report, as filed on November 12, 2003 and
incorporated by reference herein)
|
|
10.8#
|
Asset
Purchase Agreement dated May 7, 2004 between Cytori Therapeutics, Inc. and
MAST Biosurgery AG (filed as Exhibit 2.1 to our Form 8-K Current Report,
as filed on May 28, 2004 and incorporated by reference
herein.)
|
|
10.8.1
|
Settlement
Agreement dated August 9, 2005, between MAST Biosurgery AG, MAST
Biosurgery, Inc. and the Company (filed as Exhibit 10.26 to our Form 10-Q,
which was filed on November 14, 2005 and incorporated by reference
herein)
|
|
10.9#
|
Offer
Letter for the Position of Chief Financial Officer dated June 2, 2004
between the Company and Mark Saad (filed as Exhibit 10.18 to our
Form 10-Q Quarterly Report, as filed on August 16, 2004 and
incorporated by reference herein)
|
|
10.10#
|
2004
Equity Incentive Plan of Cytori Therapeutics, Inc. (filed as
Exhibit 10.1 to our Form 8-K Current Report, as filed on August
27, 2004 and incorporated by reference herein)
|
|
10.10.1#
|
Board
of Directors resolution adopted November 9, 2006 regarding determination
of fair market value for stock option grant purposes (filed as
Exhibit 10.10.1 to our Form 10-K Annual Report, as filed on
March 30, 2007 and incorporated by reference herein)
|
|
10.11
|
Exclusive
Distribution Agreement, effective July 16, 2004 by and between the Company
and Senko Medical Trading Co. (filed as Exhibit 10.25 to our
Form 10-Q Quarterly Report, as filed on November 15, 2004 and
incorporated by reference herein)
|
|
10.12#
|
Notice
and Agreement for Stock Options Grant Pursuant to Cytori Therapeutics,
Inc. 1997 Stock Option and Stock Purchase Plan; (Nonstatutory) (filed as
Exhibit 10.19 to our Form 10-Q Quarterly Report, as filed on
November 15, 2004 and incorporated by reference herein)
|
|
10.13#
|
Notice
and Agreement for Stock Options Grant Pursuant to Cytori Therapeutics,
Inc. 1997 Stock Option and Stock Purchase Plan; (Nonstatutory) with Cliff
(filed as Exhibit 10.20 to our Form 10-Q Quarterly Report, as
filed on November 15, 2004 and incorporated by reference
herein)
|
|
10.14#
|
Notice
and Agreement for Stock Options Grant Pursuant to Cytori Therapeutics,
Inc. 1997 Stock Option and Stock Purchase Plan; (Incentive) (filed as
Exhibit 10.21 to our Form 10-Q Quarterly Report, as filed on
November 15, 2004 and incorporated by reference herein)
|
|
10.15#
|
Notice
and Agreement for Stock Options Grant Pursuant to Cytori Therapeutics,
Inc. 1997 Stock Option and Stock Purchase Plan; (Incentive) with Cliff
(filed as Exhibit 10.22 to our Form 10-Q Quarterly Report, as
filed on November 15, 2004 and incorporated by reference
herein)
|
|
10.16#
|
Form
of Options Exercise and Stock Purchase Agreement Relating to the 2004
Equity Incentive Plan (filed as Exhibit 10.23 to our Form 10-Q
Quarterly Report, as filed on November 15, 2004 and incorporated by
reference herein)
|
|
10.17#
|
Form
of Notice of Stock Options Grant Relating to the 2004 Equity Incentive
Plan (filed as Exhibit 10.24 to our Form 10-Q Quarterly Report,
as filed on November 15, 2004 and incorporated by reference
herein)
|
|
10.18#
|
Separation
Agreement and General Release dated July 15, 2005, between John K. Fraser
and the Company (filed as Exhibit 10.25 to our Form 10-Q Quarterly Report
as filed on November 14, 2005 and incorporated by reference
herein)
|
|
10.19#
|
Consulting
Agreement dated July 15, 2005, between John K. Fraser and the Company
(filed as Exhibit 10.28 to our Form 10-Q Quarterly Report as filed on
November 14, 2005 and incorporated by reference herein)
|
|
10.20
|
Agreement
Between Owner and Contractor dated October 10, 2005, between Rudolph and
Sletten, Inc. and the Company (filed as Exhibit 10.20 to our Form 10-K
Annual Report as filed on March 30, 2006 and incorporated by reference
herein)
|
|
10.21#
|
Severance
Agreement and General Release dated August 10, 2005, between Sharon V.
Schulzki and the Company (filed as Exhibit 10.27 to our Form 10-Q
Quarterly report as filed on November 14, 2005 and incorporated by
reference herein)
|
|
10.22
|
Common
Stock Purchase Agreement dated April 28, 2005, between Olympus Corporation
and the Company (filed as Exhibit 10.21 to our Form 10-Q Quarterly Report
as filed on August 15, 2005 and incorporated by reference
herein)
|
|
10.23
|
Sublease
Agreement dated May 24, 2005, between Biogen Idec, Inc. and the Company
(filed as Exhibit 10.21 to our Form 10-Q Quarterly Report as filed on
August 15, 2005 and incorporated by reference herein)
|
|
10.24#
|
Employment
Offer Letter to Doug Arm, Vice President of Development—Biologics, dated
February 1, 2005 (filed as Exhibit 10.21 to our Form 10-Q Quarterly Report
as filed on August 15, 2005 and incorporated by reference
herein)
|
|
10.25#
|
Employment
Offer Letter to Alex Milstein, Vice-President of Clinical Research, dated
May 1, 2005 (filed as Exhibit 10.21 to our Form 10-Q Quarterly Report as
filed on August 15, 2005 and incorporated by reference
herein)
|
|
10.26#
|
Employment
Offer Letter to John Ransom, Vice-President of Research, dated November
15, 2005 (filed as Exhibit 10.26 to our Form 10-K Annual Report as filed
on March 30, 2006 and incorporated by reference herein)
|
|
10.27+
|
Joint
Venture Agreement dated November 4, 2005, between Olympus Corporation and
the Company (filed as Exhibit 10.27 to our Form 10-K Annual Report as
filed on March 30, 2006 and incorporated by reference
herein)
|
|
10.28+
|
License/
Commercial Agreement dated November 4, 2005, between Olympus-Cytori, Inc.
and the Company (filed as Exhibit 10.28 to our Form 10-K Annual Report as
filed on March 30, 2006 and incorporated by reference
herein)
|
|
10.28.1
|
Amendment
One to License/ Commercial Agreement dated November 14, 2007, between
Olympus-Cytori, Inc. and the Company (filed herewith)
|
|
10.29+
|
License/
Joint Development Agreement dated November 4, 2005, between Olympus
Corporation, Olympus-Cytori, Inc. and the Company (filed as Exhibit 10.29
to our Form 10-K Annual Report as filed on March 30, 2006 and incorporated
by reference herein)
|
|
10.30+
|
Shareholders
Agreement dated November 4, 2005, between Olympus Corporation and the
Company (filed as Exhibit 10.30 to our Form 10-K Annual Report as filed on
March 30, 2006 and incorporated by reference herein)
|
|
10.31+
|
Exclusive
Negotiation Agreement with Olympus Corporation, dated February 22, 2006
(filed as Exhibit 10.31 to our Form 10-Q Quarterly Report as filed on May
15, 2006 and incorporated by reference herein)
|
|
10.32
|
Common
Stock Purchase Agreement, dated August 9, 2006, by and between Cytori
Therapeutics, Inc. and Olympus Corporation (filed as Exhibit 10.32 to our
Form 8-K Current Report as filed on August 15, 2006 and incorporated by
reference herein)
|
|
10.33
|
Form
of Common Stock Subscription Agreement, dated August 9, 2006 (Agreements
on this form were signed by Cytori and each of respective investors in the
Institutional Offering) (filed as Exhibit 10.33 to our Form 8-K Current
Report as filed on August 15, 2006 and incorporated by reference
herein)
|
|
10.34
|
Placement
Agency Agreement, dated August 9, 2006, between Cytori Therapeutics, Inc.
and Piper Jaffray & Co. (filed as Exhibit 10.34 to our Form 8-K
Current Report as filed on August 15, 2006 and incorporated by reference
herein)
|
|
10.35#
|
Stock
Option Extension Agreement between Bruce A. Reuter and Cytori
Therapeutics, Inc. effective July 25, 2006 (filed as Exhibit 10.35 to our
Form 10-Q Quarterly Report as filed on November 145, 2006 and incorporated
by reference herein)
|
|
10.36#
|
Stock
Option Extension Agreement between Elizabeth A. Scarbrough and Cytori
Therapeutics, Inc. effective July 25, 2006 (filed as Exhibit 10.36 to our
Form 10-Q Quarterly Report as filed on November 14, 2006 and incorporated
by reference herein)
|
|
10.37#
|
Employment
Agreement between Bruce A. Reuter and Cytori Therapeutics, Inc. effective
July 25, 2006 (filed as Exhibit 10.37 to our Form 10-Q Quarterly Report as
filed on November 14, 2006 and incorporated by reference
herein)
|
|
10.38#
|
Employment
Agreement between Elizabeth A. Scarbrough and Cytori Therapeutics, Inc.
effective July 25, 2006 (filed as Exhibit 10.38 to our Form 10-Q Quarterly
Report as filed on November 14, 2006 and incorporated by reference
herein)
|
|
10.39+
|
Exclusive
License Agreement between us and the Regents of the University of
California dated October 16, 2001 (filed as Exhibit 10.10 to our Form 10-K
Annual Report as filed on March 31, 2003 and incorporated by reference
herein)
|
|
10.39.1
+
|
Amended
and Restated Exclusive License Agreement, effective September 26, 2006, by
and between The Regents of the University of California and Cytori
Therapeutics, Inc. (filed as Exhibit 10.39 to our Form 10-Q Quarterly
Report as filed on November 14, 2006 and incorporated by reference
herein)
|
|
10.40#
|
Stock
Option Extension Agreement between Charles Galetto and Cytori
Therapeutics, Inc. signed on May 24, 2006 and effective as of June 1, 2006
(filed as Exhibit 10.20 to our Form 10-Q Quarterly Report as filed on
August 14, 2006 and incorporated by reference herein)
|
|
10.41#
|
Part-time
Employment Agreement between Charles Galetto and Cytori Therapeutics, Inc.
signed on May 24, 2006 and effective as of June 1, 2006 (filed as Exhibit
10.21 to our Form 10-Q Quarterly Report as filed on August 14, 2006 and
incorporated by reference herein)
|
|
10.42
|
Placement
Agency Agreement, dated February 23, 2007, between Cytori Therapeutics,
Inc. and Piper Jaffray & Co. (filed as Exhibit 10.1 to our
Form 8-K Current Report as filed on February 26, 2007 and
incorporated by reference herein).
|
|
10.43
|
Financial
services advisory engagement letter agreement, dated February 16, 2007,
between Cytori Therapeutics, Inc. and WBB Securities, LLC (filed as
Exhibit 10.2 to our Form 8-K Current Report as filed on February 26, 2007
and incorporated by reference herein)
|
|
10.44
|
Form
of Subscription Agreement, dated February 23, 2007 (filed as Exhibit 10.3
to our Form 8-K Current Report as filed on February 26, 2007 and
incorporated by reference herein)
|
|
10.45
|
Form
of Warrant to be dated February 28, 2007 (filed as Exhibit 10.4 to our
Form 8-K Current Report as filed on February 26, 2007 and incorporated by
reference herein)
|
|
10.46
|
Common
Stock Purchase Agreement, dated March 28, 2007, by and between Cytori
Therapeutics, Inc. and Green Hospital Supply, Inc. (filed as Exhibit 10.46
to our Form 10-Q Quarterly Report as filed on May 11, 2007 and
incorporated by reference herein).
|
|
10.47
|
Consulting
Agreement, dated May 3, 2007, by and between Cytori Therapeutics, Inc. and
Marshall G. Cox. (filed as Exhibit 10.47 to our Form 10-Q
Quarterly Report as filed on August 14, 2007 and incorporated by reference
herein).
|
|
10.48+
|
Master
Cell Banking and Cryopreservation Agreement, effective August 13, 2007, by
and between Green Hospital Supply, Inc. and Cytori
Therapeutics, Inc. (filed as Exhibit 10.48 to our Form 10-Q Quarterly
Report as filed on November 13, 2007 and incorporated by reference
herein).
|
|
10.49+
|
License
& Royalty Agreement, effective August 23, 2007, by and between
Olympus-Cytori, Inc. and Cytori
Therapeutics, Inc. (filed as Exhibit 10.49 to our Form 10-Q
Quarterly Report as filed on November 13, 2007 and incorporated by
reference herein).
|
|
10.50
|
General
Release Agreement, dated August 13, 2007, between John Ransom and Cytori
Therapeutics, Inc. (filed as Exhibit 10.49 to our Form 10-Q Quarterly
Report as filed on November 13, 2007 and incorporated by reference
herein).
|
|
10.51
|
Common
Stock Purchase Agreement, dated February 8, 2008, by and between Green
Hospital Supply, Inc. and Cytori
Therapeutics, Inc. (filed as Exhibit 10.51 to our Form 8-K Current Report
as filed on February 19, 2008 and incorporated by reference
herein).
|
|
10.51.1
|
Amendment
No. 1 to Common Stock Purchase Agreement, dated February 29, 2008, by and
between Green Hospital Supply, Inc. and Cytori Therapeutics, Inc. (filed
as Exhibit 10.51.1 to our Form 8-K Current Report as filed on February 29,
2008 and incorporated by reference herein).
|
|
10.52#
|
Agreement
for Acceleration and/or Severance, dated January 31, 2008, by and between
Christopher J. Calhoun and Cytori
Therapeutics, Inc. (filed herewith).
|
|
10.53#
|
Agreement
for Acceleration and/or Severance, dated January 31, 2008, by and between
Marc H. Hedrick and Cytori
Therapeutics, Inc. (filed herewith).
|
|
10.54#
|
Agreement
for Acceleration and/or Severance, dated January 31, 2008, by and between
Mark E. Saad and Cytori
Therapeutics, Inc. (filed herewith).
|
|
14.1
|
Code
of Ethics (filed as Exhibit 14.1 to our Annual Report on
Form 10-K which was filed on March 30, 2004 and incorporated by
reference herein)
|
|
23.1
|
Consent
of KPMG LLP, Independent Registered Public Accounting Firm (filed
herewith).
|
|
31.1
|
Certification
of Principal Executive Officer Pursuant to Securities Exchange Act Rule
13a-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002 (filed herewith).
|
|
31.2
|
Certification
of Principal Financial Officer Pursuant to Securities Exchange Act Rule
13a-14(a), as adopted pursuant to Section 302 of the Sarbanes-Oxley Act of
2002 (filed herewith).
|
|
32.1
|
Certifications
Pursuant to 18 U.S.C. Section 1350/ Securities Exchange Act Rule
13a-14(b), as adopted pursuant to Section 906 of the Sarbanes - Oxley Act
of 2002 (filed herewith).
|
_______________________________________
+ Portions
of these exhibits have been omitted pursuant to a request for confidential
treatment.
# Indicates
management contract or compensatory plan or arrangement.
85
SIGNATURES
Pursuant
to the requirements of Section 13 or 15(d) of the Securities Exchange Act of
1934, the registrant has duly caused this registration statement to be signed on
its behalf by the undersigned, thereunto duly authorized.
CYTORI
THERAPEUTICS, INC.
|
||
By:
|
/s/
Christopher J. Calhoun
|
|
Christopher
J. Calhoun
|
||
Chief
Executive Officer
|
||
March
14, 2008
|
Pursuant
to the requirements of the Securities Exchange Act of 1934, this annual report
has been signed below by the following persons on behalf of the registrant and
in the capacities and on the dates indicated.
SIGNATURE
|
TITLE
|
DATE
|
||
/s/
Ronald D. Henriksen
|
Chairman
of the Board of Directors
|
March
14, 2008
|
||
Ronald
D. Henriksen
|
||||
/s/
Christopher J. Calhoun
|
Chief
Executive Officer, Vice-Chairman, Director (Principal Executive
Officer)
|
March
14, 2008
|
||
Christopher
J. Calhoun
|
||||
/s/
Marc H. Hedrick, MD
|
President,
Director
|
March
14, 2008
|
||
Marc
H. Hedrick, MD
|
||||
/s/
Mark E. Saad
|
Chief
Financial Officer (Principal Financial Officer)
|
March
14, 2008
|
||
Mark
E. Saad
|
||||
/s/
John W. Townsend
|
Chief
Accounting Officer
|
March
14, 2008
|
||
John
W. Townsend
|
||||
/s/
David M. Rickey
|
Director
|
March
14, 2008
|
||
David
M. Rickey
|
||||
/s/
Rick Hawkins
|
Director
|
March
14, 2008
|
||
Rick
Hawkins
|
||||
/s/
E. Carmack Holmes, MD
|
Director
|
March
14, 2008
|
||
E.
Carmack Holmes, MD
|
||||
/s/
Paul W. Hawran
|
Director
|
March
14, 2008
|
||
Paul
W. Hawran
|
86