Vaxart, Inc. - Quarter Report: 2010 June (Form 10-Q)
UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
WASHINGTON,
D.C. 20549
FORM
10-Q
x QUARTERLY
REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF
1934
For
the quarterly period ended June 26, 2010
OR
¨ 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: 000-04829
Nabi
Biopharmaceuticals
(Exact
name of registrant as specified in its charter)
Delaware
|
59-1212264
|
|
(State
or other jurisdiction of
incorporation
or organization)
|
(I.R.S.
Employer
Identification
No.)
|
12276
Wilkins Avenue, Rockville, MD 20852
(Address
of principal executive offices, including zip code)
(301)
770-3099
(Registrant’s
telephone number, including area code)
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 twelve 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 x No
¨
Indicate
by check mark whether the registrant has submitted electronically and posted on
its corporate Web site, if any, every Interactive Data File required to be
submitted and posted pursuant to Rule 405 of Regulation S-T (§232.405 of this
chapter) during the preceding 12 months (or for such shorter period that the
registrant was required to submit and post such
files). Yes ¨
No ¨
Indicate
by check mark whether the registrant is a large accelerated filer, an
accelerated filer, or a non-accelerated filer. See definition of “accelerated
filer, large accelerated filer” and “small reporting company” in Rule 12b-2 of
the Exchange Act.
Large accelerated filer
|
¨
|
|
Accelerated filer
|
x
|
||
Non-accelerated
filer
|
¨
|
|
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 ¨ No
x
The
number of shares outstanding of the registrant’s common stock, par value $.10
per share, at July 30, 2010 was 42,995,802 shares.
Nabi
Biopharmaceuticals
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Page No.
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PART I.
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Item 1.
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3
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3
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4
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5
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6
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Item 2.
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12
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Item
3.
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15
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Item 4.
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15
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PART II.
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16
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Item 1.
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16
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Item 1A.
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16
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Item 2.
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16
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Item
5.
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17
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Item 6.
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17
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18
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Certifications
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Nabi
Biopharmaceuticals
(Unaudited)
(In
thousands)
June
26,
|
December
26,
|
|||||||
2010
|
2009
|
|||||||
ASSETS
|
||||||||
Current
assets:
|
||||||||
Cash
and cash equivalents
|
$ | 32,454 | $ | 59,510 | ||||
Marketable
securities
|
71,206 | 59,489 | ||||||
Receivables
|
4,585 | 9,122 | ||||||
Prepaid
expenses and other current assets
|
1,455 | 1,572 | ||||||
Total
current assets
|
109,700 | 129,693 | ||||||
Marketable
securities
|
14,355 | - | ||||||
Property
and equipment, net
|
601 | 855 | ||||||
Other
assets
|
635 | 769 | ||||||
Total
assets
|
$ | 125,291 | $ | 131,317 | ||||
LIABILITIES
AND STOCKHOLDERS' EQUITY
|
||||||||
Current
liabilities:
|
||||||||
Accounts
payable
|
$ | 3,350 | $ | 1,735 | ||||
Accrued
expenses and other current liabilities
|
5,409 | 4,961 | ||||||
Deferred
revenue, current portion
|
13,068 | 18,447 | ||||||
2.875%
convertible senior notes, net
|
- | 5,951 | ||||||
Current
liabilities of discontinued operations
|
2,207 | 2,816 | ||||||
Total
current liabilities
|
24,034 | 33,910 | ||||||
Deferred
revenue
|
36,631 | - | ||||||
Total
liabilities
|
60,665 | 33,910 | ||||||
Stockholders'
equity:
|
||||||||
Convertible
preferred stock
|
- | - | ||||||
Common
stock
|
6,315 | 6,278 | ||||||
Capital
in excess of par value
|
367,319 | 365,841 | ||||||
Treasury
stock
|
(86,665 | ) | (50,267 | ) | ||||
Other
comprehensive income (loss)
|
8 | (20 | ) | |||||
Accumulated
deficit
|
(222,351 | ) | (224,425 | ) | ||||
Total
stockholders' equity
|
64,626 | 97,407 | ||||||
Total
liabilities and stockholders' equity
|
$ | 125,291 | $ | 131,317 |
See
accompanying notes to condensed consolidated financial
statements.
Nabi
Biopharmaceuticals
(Unaudited)
(In
thousands, except per share amounts)
For
the Three Months Ended
|
For
the Six Months Ended
|
|||||||||||||||
June
26,
|
June
27,
|
June
26,
|
June
27,
|
|||||||||||||
2010
|
2009
|
2010
|
2009
|
|||||||||||||
Revenue
|
||||||||||||||||
Revenue
|
$ | 4,849 | $ | - | $ | 18,590 | $ | - | ||||||||
Operating
expenses:
|
||||||||||||||||
Costs
of services
|
615 | - | 1,285 | - | ||||||||||||
General
and administrative expenses
|
1,196 | 2,355 | 2,965 | 5,445 | ||||||||||||
Research
and development expenses
|
6,525 | 3,440 | 12,435 | 7,206 | ||||||||||||
Operating
income (loss)
|
(3,487 | ) | (5,795 | ) | 1,905 | (12,651 | ) | |||||||||
Interest
income
|
67 | 83 | 91 | 270 | ||||||||||||
Interest
expense
|
(45 | ) | (136 | ) | (187 | ) | (497 | ) | ||||||||
Other
income (expense), net
|
59 | 40 | 265 | 24 | ||||||||||||
Net
income (loss)
|
$ | (3,406 | ) | $ | (5,808 | ) | $ | 2,074 | $ | (12,854 | ) | |||||
Basic
income (loss) per share
|
$ | (0.08 | ) | $ | (0.11 | ) | $ | 0.04 | $ | (0.25 | ) | |||||
Diluted
income (loss) per share
|
$ | (0.08 | ) | $ | (0.11 | ) | $ | 0.04 | $ | (0.25 | ) | |||||
Basic
weighted average shares outstanding
|
44,377 | 50,974 | 46,456 | 51,094 | ||||||||||||
Diluted
weighted average shares outstanding
|
44,377 | 50,974 | 46,691 | 51,094 |
See accompanying notes to condensed
consolidated financial statements.
Nabi
Biopharmaceuticals
(Unaudited)
(In
thousands)
For
the Six Months Ended
|
||||||||
June
26,
|
June
27,
|
|||||||
2010
|
2009
|
|||||||
Cash
flow from operating activities:
|
||||||||
Net
income (loss) from continuing operations
|
$ | 2,074 | $ | (12,854 | ) | |||
Adjustments
to reconcile net income (loss) from continuing operations to net cash
provided by (used in) operating activities from continuing
operations:
|
||||||||
Depreciation
and amortization
|
220 | 255 | ||||||
Accretion
of discount on convertible senior notes
|
99 | 306 | ||||||
Share-based
compensation
|
1,102 | 904 | ||||||
Other
|
(4 | ) | 6 | |||||
Changes
in assets and liabilities:
|
||||||||
Receivables
|
4,538 | - | ||||||
Prepaid
expenses and other assets
|
240 | (426 | ) | |||||
Accounts
payable, accrued expenses and other
|
1,509 | (1,035 | ) | |||||
Deferred
revenue
|
31,252 | - | ||||||
Net
cash provided by (used in) operating activities from continuing
operations
|
41,030 | (12,844 | ) | |||||
Net
cash provided by (used in) operating activities from discontinued
operations
|
(609 | ) | 4,488 | |||||
Net
cash provided by (used in) operating activities
|
40,421 | (8,356 | ) | |||||
Cash
flow from investing activities:
|
||||||||
Proceeds
from sales and maturities of marketable securities
|
64,516 | 22,836 | ||||||
Purchases
of marketable securities
|
(90,560 | ) | - | |||||
Proceeds
from sales of property and equipment
|
50 | - | ||||||
Capital
expenditures
|
(2 | ) | - | |||||
Net
cash provided by (used in) investing activities
|
(25,996 | ) | 22,836 | |||||
Cash
flow from financing activities:
|
||||||||
Proceeds
from issuances of common stock for employee benefit plans
|
412 | 297 | ||||||
Purchase
of common stock for treasury
|
(35,843 | ) | (3,466 | ) | ||||
Repurchase
of convertible senior notes
|
(6,050 | ) | (10,091 | ) | ||||
Net
cash used in financing activities
|
(41,481 | ) | (13,260 | ) | ||||
Net
increase (decrease) in cash and cash equivalents
|
(27,056 | ) | 1,220 | |||||
Cash
and cash equivalents at beginning of period
|
59,510 | 106,438 | ||||||
Cash
and cash equivalents at end of period
|
$ | 32,454 | $ | 107,658 |
See
accompanying notes to condensed consolidated financial
statements.
Nabi
Biopharmaceuticals
(Unaudited)
NOTE
1 COMPANY OVERVIEW
We are a
biopharmaceutical company focused on the development of vaccines addressing the
unmet medical need of nicotine addiction. We leverage our experience and
knowledge in powering the human immune system to target this serious unmet
medical need. We initiated a strategic alternatives process beginning in 2006 to
enhance shareholder value that has resulted in the sale, licensure or grant of
an option to acquire all of our marketed products and major pipeline
products. Our sole
remaining product currently in development is NicVAX® [Nicotine Conjugate Vaccine],
an innovative and proprietary investigational vaccine for treatment of nicotine
addiction and prevention of smoking relapse based on patented technology. In the
first quarter 2010 we granted to GlaxoSmithKline Biologicals S.A. (GSK) (i) an
option to exclusively in-license NicVAX on a worldwide basis and (ii) a license
to develop follow-on next-generation nicotine vaccines using our intellectual
property.
Product
Development
The
smoking cessation market is estimated to exceed $4 billion annually and is
currently considered to be a largely unmet medical need. Nicotine is a
non-immunogenic small molecule that, upon inhalation into the lungs, quickly
passes into the bloodstream and subsequently reaches the brain by crossing the
blood-brain barrier. Once in the brain, the nicotine binds to specific nicotine
receptors resulting in the release of stimulants, such as dopamine, a chemical
linked to pleasure and to addiction. NicVAX is designed to stimulate the immune
system to produce antibodies that bind to nicotine in the bloodstream and
prevent it from crossing the blood-brain barrier and entering the brain. With a
reduced amount of nicotine reaching the brain, fewer stimulants are released and
the pleasurable, positive-reinforcing effects of nicotine are diminished,
thereby making it easier to quit smoking. Pre-clinical studies with NicVAX have
shown that vaccination prevents nicotine from reaching the brain and blocks the
effects of nicotine, including effects that can lead to addiction or can
reinforce and maintain addiction, in animals. In humans, NicVAX, in combination
with quit-counseling, has been clinically demonstrated to help smokers, who want
to quit, achieve long-term abstinence. We believe NicVAX may have advantages
over existing treatment therapies because the anti-nicotine antibodies limit the
ability of nicotine to enter the brain. Moreover, these anti-nicotine antibodies
persist for six to 12 months following vaccination. This is important due to the
extremely high relapse rate that has been observed in smokers who attempt to
quit smoking.
In
November 2007, we announced the successful completion of a Phase IIb
“proof-of-concept” clinical trial for NicVAX that showed statistically
significant rates of smoking cessation and continuous long-term smoking
abstinence at six and 12 months for subjects injected with NicVAX as compared
with subjects injected with placebo. In October 2008, we announced the results
of a Phase II schedule optimization immunogenicity study assessing the antibody
response and safety of a six-dose immunization schedule. This study showed that
significantly higher antibody levels can be generated earlier in a higher
percentage of subjects than in the Phase IIb proof-of-concept study and that the
revised dose regimen continued to be well tolerated. These key results have
supported the basis of our design for the NicVAX Phase III trials. In December
2008, we announced that we had reached agreement with the U.S. Food and Drug
Administration (FDA) on a Special Protocol Assessment (SPA) for the pivotal
Phase III clinical trials for NicVAX. The SPA forms the foundation to support
approval of a New Drug Application (NDA). In June 2009, we announced
that we received Scientific Advice from the European Medicines Agency (EMA)
which is well aligned with our SPA agreement with the FDA regarding the design
of the trial. In September 2009, we announced that we received a $10 million
grant from the National Institute on Drug Abuse (NIDA), to partially offset the
cost of the first of two Phase III studies that are required by the FDA to
support NicVAX’s licensure. In October 2009, we also announced the initiation of
an investigator initiated clinical trial in the Netherlands to test the efficacy
of a combined therapy of NicVAX with varenicline, or Chantix. In November 2009,
we announced the initiation of the first of two Phase III efficacy trials in the
U.S. In March 2010, we initiated the second Phase III trial and in July 2010, we
announced the completion of enrollment in the first Phase III
trial. As such, we believe that NicVAX is at a more advanced stage of
development than any potentially competing smoking cessation
vaccine.
NOTE
2 BASIS OF PRESENTATION AND SUMMARY OF SIGNIFICANT ACCOUNTING
POLICIES
In the
opinion of management, the accompanying condensed consolidated financial
statements include all adjustments, consisting of normal recurring adjustments,
which are necessary to present fairly our financial position, results of
operations and cash flows. The condensed consolidated balance sheet at December
26, 2009 has been derived from audited consolidated financial statements at that
date. Our interim results of operations are not necessarily
indicative of the results that may occur for the full fiscal year. Certain
information and footnote disclosure normally included in financial statements
prepared in accordance with generally accepted accounting principles in the
United States of America (U.S. GAAP) have been condensed or omitted pursuant to
instructions, rules and regulations prescribed by the U.S. Securities and
Exchange Commission. We believe that the disclosures provided herein
are adequate to make the information presented not misleading when these
unaudited condensed consolidated financial statements are read in conjunction
with the Consolidated Financial Statements and Notes included in our Annual
Report on Form 10-K for the year ended December 26, 2009 filed with the
Securities and Exchange Commission.
Principles of consolidation and
presentation: The consolidated financial statements include the accounts
of Nabi Biopharmaceuticals and our controlled subsidiaries (referred to as
“Nabi,” the “Company,” “us,” or “we” throughout this report). All significant
inter-company accounts and transactions are eliminated in consolidation. All of
our consolidated subsidiaries are dormant or are otherwise
non-operative. Our fiscal year ends on the last Saturday of December;
consequently, we will periodically have a 53-week fiscal year.
Accounting estimates: The
preparation of financial statements in conformity with accounting principles
U.S. GAAP requires management to make estimates and assumptions that affect the
reported amounts of assets and liabilities and disclosure of contingent assets
and liabilities at the date of the financial statements and the reported amounts
of income and expenses during the reporting period, including such amounts
related to discontinued operations. Actual results could differ from those
estimates.
Financial instruments: The
carrying amounts of financial instruments including cash equivalents, marketable
securities, and accounts payable approximated fair value as of June 26, 2010 and
December 26, 2009, because of the relatively short-term maturity of the
instruments or because of their nature. The carrying value of our Convertible
Senior Notes, at December 26, 2009 was approximately $6.0 million (compared to
the approximate fair value of $5.7 million based on quoted market prices). We
repurchased the entire remaining balance of our Convertible Senior Notes on
April 15, 2010.
Cash, cash equivalents and
marketable securities: Cash equivalents consist of investments in low
risk, highly liquid securities with original maturities of 90 days or less.
Marketable securities consist of low risk fixed income investment instruments
such as government obligations, government agencies and FDIC backed notes with
maturities typically less than eighteen months. Marketable securities
are classified as available-for-sale and recorded at market value; unrealized
gains and losses on those securities are reflected in other comprehensive income
(loss). We assess the risk of impairment related to securities held in our
investment portfolio on a regular basis and noted no “permanent” or “other than
temporary” impairment during the three- and six months ended June 26, 2010. Our
investment policies and procedures are reviewed periodically including by
management and our audit committee.
Deferred
revenue: Deferred revenue consists mainly of our initial
upfront payments received from the sale and license agreements that we have not
yet recognized as revenue. We recognize revenue as we satisfy our performance
obligations as specified in the agreements.
Collaborative
arrangements: We are an active participant with exposure to
significant risks and rewards of commercialization relating to the development
of NicVAX. For costs incurred and revenues generated from third
parties where we are deemed to be the principal participant, we recognize
revenues and costs using the gross basis of accounting; otherwise we use the net
basis of accounting.
Revenue
recognition: Our contracts and agreements may include multiple
elements and deliverables, including licenses, options, research and development
activities, participation on joint steering committees, and contract
manufacturing, among other elements. When we determine that an element has
stand alone value to our customer, we allocate a portion of the total contract
price to that element based on its objectively determined and relative fair
value, and recognize revenue for that element according to its characteristics.
When we cannot reliably and objectively determine fair value of any delivered
element, we combine that element with undelivered elements as a single unit of
accounting. Revenues related to substantive milestone activities are recognized
as revenue in the period such activities are completed. We analyze
cost reimbursable grants and contracts to determine whether we should report
such reimbursements as revenue or as an offset to our expenses
incurred.
Research and development expenses:
Research and development costs are expensed as incurred; advanced
payments are deferred and subsequently expensed over the period of performance.
Research and development expenses include direct labor costs as well as the
costs of contractors and other direct and indirect expenses (including an
allocation of the costs of facilities). We expense amounts payable to third
parties under collaborative product development agreements at the earlier of the
milestone achievement or as payments become contractually due. For
the three- and six months ended June 26, 2010, the Company recorded
approximately $3.4 million and $4.5 million respectively of cost reimbursements
from government grants as an offset to research and development expenses (none
for the three- and six months ended June 2009).
Share-based compensation: We
account for share-based compensation at fair value; accordingly we expense the
estimated fair value of share-based awards made in exchange for employee
services over the requisite employee service period. Share-based compensation
cost is determined at the grant date using an option pricing model. The value of
the award that is ultimately expected to vest is recognized as expense on a
straight-line basis over the employee’s requisite service period, which is
generally the vesting period. Total share-based compensation expense for the
three- and six months ended June 26, 2010 was $0.7 million and $1.1 million
respectively, and for the three- and six months ended June 27, 2009, was $0.5
million and $0.9 million respectively.
Income taxes: We follow the
asset and liability approach for financial accounting and reporting of income
taxes, which requires, among other things, recognition of future tax benefits
and liabilities measured at enacted rates attributable to temporary differences
between financial statement and income tax bases of assets and liabilities and
to tax net operating loss carryforwards to the extent that realization of these
benefits is more likely than not. We periodically evaluate the realizability of
our net deferred tax assets. A valuation allowance is established when the
Company believes that it is more likely than not that its deferred tax assets
will not be realized. Changes in valuation allowances from period to period are
included in the Company’s tax provision in the period of change. We consider
discontinued operations for purposes of determining the amount of tax benefits
that result from a loss from continuing operations.
Comprehensive income (loss):
We calculate comprehensive income (loss) as the total of our net income (loss)
and all other changes in equity (other than transactions with owners), including
foreign currency translation adjustments and unrealized gains (losses) on our
available for sale marketable securities. At June 26, 2010 our total net
unrealized gains on our marketable securities was $8 thousand.
Income (loss) per share:
Basic income (loss) per share is computed by dividing consolidated net
income (loss) available to common shareholders by the weighted average number of
common shares outstanding during the period. The Company’s unvested
restricted shares contain non-forfeitable rights to dividends, and therefore are
considered to be participating securities; the calculation of basic and diluted
income per share excludes net income attributable to the unvested restricted
shares from the numerator and excludes the impact of the shares from the
denominator.
For
periods of net income when the effects are dilutive, diluted earnings per share
is computed by dividing net income available to common shareholders (as adjusted
for interest expense on our Convertible Senior Notes net of taxes when they were
outstanding) by the weighted average number of shares outstanding and the
dilutive impact of all dilutive potential common shares. Dilutive potential
common shares consist primarily of stock options and the common shares
underlying our Convertible Senior Notes when they were outstanding. The dilutive
impact of potential common shares resulting from stock options is determined by
applying the treasury stock method. The dilutive impact of potential common
shares resulting from our Convertible Senior Notes was determined by applying
the “if converted” method.
For all
periods of net loss, diluted loss per share is calculated similarly to basic
loss per share because the impact of all dilutive potential common shares is
anti-dilutive due to the net losses; accordingly, diluted loss per share is the
same as basic loss per share for the three months ended June 26, 2010 and the
three- and six months ended June 27, 2009. For the six months ended
June 26, 2010, the computation of diluted income per share differed from the
computation of basic income per share as a result of a (i) numerator adjustment
for net income allocated to participating securities and (ii) denominator
adjustment related to stock options using the treasury stock
method. A total of approximately 4.2 million and 3.9 million
potential dilutive shares related to stock options have been excluded in the
calculation of diluted net loss per share for the three- and six months ended
June 26, 2010, respectively, as their inclusion would be
anti-dilutive.
Segment information: We
currently operate in a single business segment.
New accounting
pronouncements: There are several new accounting and disclosure
requirements that we will be required to adopt in the future, primarily with
respect to revenue recognition practices. In 2011, we will be required to adopt
new revenue recognition practices relating to revenue arrangements that include
multiple elements. Our license agreements with GSK related to our PentaStaph and
NicVAX products may be affected by the new accounting and disclosure
requirements. We are currently evaluating any potential impact these new
requirements may have on our consolidated financial statements.
NOTE
3 AVAILABLE FOR SALE INVESTMENTS
The
amortized cost, gross unrealized gains, gross unrealized losses and estimated
fair value of available-for-sale investments by security classification as of
June 26, 2010 were as follows:
Gross
|
Gross
|
Estimated
|
||||||||||||||
(In
thousands)
|
Amortized
Costs
|
Unrealized
Gains
|
Unrealized
Losses
|
Fair
Values
|
||||||||||||
US
Treasury bills
|
$ | 14,996 | $ | - | $ | - | $ | 14,996 | ||||||||
Government-sponsored
securities
|
64,874 | 15 | (2 | ) | 64,887 | |||||||||||
Corporate
debt securities
|
5,683 | 1 | (6 | ) | 5,678 | |||||||||||
Total
securities
|
$ | 85,553 | $ | 16 | $ | (8 | ) | $ | 85,561 |
During
2010 and 2009 we had no significant realized gains (losses) on sales of
available-for-sale securities. Gains and losses on available-for-sale
securities are based on the specific identification method.
The
contractual maturities of available-for-sale investments by security
classification as of June 26, 2010 were as follows:
(In
thousands)
|
Total
|
Less
than 12 Months
|
12
Months or More
|
|||||||||
US
Treasury bills
|
$ | 14,996 | $ | 14,996 | $ | - | ||||||
Government-sponsored
securities
|
64,887 | 51,381 | 13,506 | |||||||||
Corporate
debt securities
|
5,678 | 4,829 | 849 | |||||||||
Total
securities
|
$ | 85,561 | $ | 71,206 | $ | 14,355 |
NOTE
4 COMMITMENTS AND CONTINGENCIES
Litigation
We are
parties to legal proceedings that we believe to be ordinary, routine litigation
incidental to the business of present or former operations. It is management’s
opinion, based on the advice of counsel, that the ultimate resolution of such
litigation will not have a material adverse effect on our financial condition,
results of operations or cash flows.
Medicare/Medicaid
Contingencies
During
2006, we engaged an outside consultant to assess our pricing programs under
Medicare/Medicaid and other governmental pricing programs during the period from
2002 through the second quarter of 2006. In connection with this review, we
identified additional liabilities related to discontinued operations for
possible overbilling under Medicare/Medicaid and other governmental pricing
programs, of which the remaining amounts due were approximately $1.9 million at
June 26, 2010 which are included in the amounts recorded as current liabilities
from discontinued operations. We intend to pay these obligations as they are
rebilled to us.
NOTE
5 INCOME TAXES
We are
subject to tax audits in all jurisdictions for which we file tax returns. Tax
audits by their very nature are often complex and can require several years to
complete. Under the tax statute of limitations applicable to the Internal
Revenue Code, we are no longer subject to U.S. federal income tax examinations
by the Internal Revenue Service for years before 2003. However, because we are
carrying forward income tax attributes, such as net operating losses and tax
credits from 2002 and earlier tax years, these attributes can still be audited
when used on returns filed in the future. Under the statutes of limitation
applicable to most state income tax laws, we are no longer subject to state
income tax examinations by tax authorities for years before 2003 in states in
which we have filed income tax returns. Certain states may take the position
that we are subject to income tax in such states even though we have not filed
income tax returns in such states and, depending on the varying state income tax
statutes and administrative practices, the statute of limitations in such states
may extend to years before 2003. We began foreign operations in 2004. We are
subject to foreign tax examinations by tax authorities for all years of
operation.
Significant
judgment is required in evaluating our tax positions and determining our
provision for income taxes. We establish reserves for tax-related uncertainties
based on estimates of whether, and the extent to which, additional taxes will be
due. These reserves are established when we believe that certain positions might
be challenged despite our belief that our tax return positions are fully
supportable. We adjust these reserves in light of changing facts and
circumstances, such as the outcome of a tax audit. The provision for income
taxes includes the impact of reserve provisions and changes to reserves that are
considered appropriate. As of June 26, 2010 we have recorded a valuation
allowance against all of our deferred tax assets. We expect our full year
effective tax rate for 2010 to be 0%.
NOTE
6 FAIR VALUE DISCLOSURES
We follow
a three-tier fair value hierarchy which prioritizes the inputs used in measuring
the fair value of our assets and liabilities. These tiers include (i) Level 1,
defined as observable inputs such as quoted prices in active markets for
identical assets, (ii) Level 2, defined as observable inputs other than Level 1
prices such as quoted prices for similar assets; quoted prices in markets that
are not active; or other inputs that are observable or can be corroborated by
observable market data for substantially the full term of the assets or
liabilities; and (iii) Level 3, defined as unobservable inputs in which little
or no market data exists, therefore requiring an entity to develop its own
assumptions.
All cash
and cash equivalents, as well as available-for-sale marketable securities, are
recorded at fair market value at June 26, 2010. The inputs used in measuring the
fair value of these instruments are considered to be Level 1 and Level 2 in
accordance with the three-tier fair value hierarchy. The fair market values are
based on period-end statements supplied by the various banks and brokers that
held the majority of our funds deposited in institutional money market mutual
funds with the remainder held in regular interest bearing and non-interest
bearing depository accounts with commercial banks.
Quoted
Prices in Active
|
Significant
Other
|
Significant
|
||||||||||||||
June
26, 2010
|
Markets
for Identical Assets
|
Observable
Inputs
|
Unobservable
Inputs
|
|||||||||||||
(In
thousands)
|
Total
|
Level
1
|
Level
2
|
Level
3
|
||||||||||||
Cash
and cash equivalents
|
$ | 32,454 | $ | 32,454 | $ | - | $ | - | ||||||||
US
Treasury bills
|
14,996 | 14,996 | - | - | ||||||||||||
Government-sponsored
enterprise securities
|
64,887 | - | 64,887 | - | ||||||||||||
Corporate
debt and other securities
|
5,678 | 3,794 | 1,884 | - | ||||||||||||
Total
|
$ | 118,015 | $ | 51,244 | $ | 66,771 | $ | - |
NOTE
7 TREASURY STOCK
Since
December 2007, our Board of Directors has approved the buyback of up to $115
million of our common stock in the open market or in privately negotiated
transactions. In the first six months of 2010, we purchased 6.7 million shares
for $36.4 million at an average cost per share of $5.47. Since the inception of
the program in December 2007 through June 26, 2010, we have repurchased a total
of 18.8 million shares for a total cost of $81.3 million, at an average price of
$4.33 per share. Subsequent to the second quarter end through July 30, 2010, we
repurchased an additional 0.6 million shares for $3.1 million, at an average
price of $5.46 per share. Repurchased shares have been accounted for as treasury
stock using the cost method.
NOTE
8 SHARE-BASED COMPENSATION
Stock
Options
A summary
of option activity under our stock compensation plans as of June 26, 2010, and
the changes during the first six months of 2010 is presented
below:
Options
|
Number
of Options
|
|||
Outstanding
at December 26, 2009
|
3,688,003 | |||
Granted
|
845,805 | |||
Exercised
|
(90,830 | ) | ||
Forfeited
|
(13,700 | ) | ||
Expired
|
(255,075 | ) | ||
Outstanding
at June 26, 2010
|
4,174,203 | |||
Exercisable
at June 26, 2010
|
2,612,680 |
We
granted options to purchase 845,805 shares at exercise prices ranging from $5.06
to $5.58 during the first six months of 2010, with an average fair value at the
date of grant of $3.54. These grants become exercisable between one and four
years after the date of grant. We estimate the fair value of each stock option
on the date of grant using a Black-Scholes option-pricing formula, applying the
following assumptions and amortize expense over the option’s vesting period
using the straight-line attribution approach:
Expected Term: The expected
term represents the period over which the share-based awards are expected to be
outstanding based on the historical experience of our employees. We estimate our
expected term to be between 4.5 and 6.3 years.
Risk-Free Interest Rate: The
Company based the risk-free interest rate used in the assumptions on the implied
yield currently available on U.S. Treasury zero-coupon issues with a remaining
term equivalent to the stock option award’s expected term. We used a
risk-free interest rate of 2.46% - 2.71% per annum.
Expected Volatility: The
volatility factor used in the assumptions is based on the historical price of
our stock over the most recent period commensurate with the expected term of the
stock option award. We used expected volatility of 74.86% - 83.59%.
Expected Dividend Yield: We
do not intend to pay dividends on common stock for the foreseeable future.
Accordingly, we used a dividend yield of zero in the assumptions.
We
recognized approximately $0.5 million and $0.8 million of expense related to
stock options in the three- and six months ended June 26, 2010,
respectively.
Restricted
Stock
A summary
of our restricted stock awards as of June 26, 2010 and the changes during the
first six months of 2010 is presented below:
Awards
|
Number
of Awards
|
|||
Nonvested
at December 26, 2009
|
356,715 | |||
Granted
|
266,038 | |||
Vested
|
(117,155 | ) | ||
Forfeited
|
(3,080 | ) | ||
Nonvested
at June 26, 2010
|
502,518 |
We
recognized approximately $0.2 million and $0.3 million of expense related to
restricted stock awards in the three- and six month periods ended June 26, 2010,
respectively. During the first six months of 2010, we granted 266,038 restricted
shares with a calculated average fair value of $5.47, which vest over four years
in equal installments after the date of the grant.
NOTE
9 LICENSES AND REVENUE ARRANGEMENTS
PentaStaph. In
2009, we sold our PentaStaph vaccine candidate and related assets to GSK for a
total consideration of up to $47.5 million. Under the terms of the sale
agreement with GSK, we received an initial cash payment of $21.5 million and
became eligible to receive an additional $26 million contingent upon four
milestone accomplishments. Two of the milestones were accomplished in the fourth
quarter of 2009 and the first quarter of 2010 resulting in revenue of $13.0
million. We believe we will achieve the two remaining milestones within the next
nine months.
We are
recognizing the upfront payment from GSK ratably over the period of our
performance obligations contained in the agreement, including participation on a
joint steering committee. We will recognize revenues related to the substantive
milestones in the periods we accomplish them.
NicVAX. In 2010,
we entered into an exclusive worldwide option and licensing agreement with GSK
for our NicVAX vaccine candidate, and the development of follow-on next
generation nicotine vaccine candidates. Under the terms of the agreement, GSK
paid us an upfront non-refundable fee of $40 million for (i) an option to
exclusively in-license NicVAX on a worldwide basis and (ii) a license to develop
follow-on next-generation nicotine vaccines using our intellectual property. In
addition to the upfront payment, we are eligible to receive option fees as well
as regulatory, development, and sales milestone payments and other payments for
NicVAX and follow-on nicotine vaccines. In total these additional payments may
exceed $460 million. We will also receive double-digit royalties on global sales
of NicVAX should GSK exercise its option as well as royalties on global sales of
next generation nicotine vaccines utilizing intellectual property acquired from
us. Under the terms of the agreement, we will be responsible for the
cost and performance of the Phase III development of NicVAX. Upon completion of
the ongoing Phase III studies, if GSK exercises its option, GSK will take
responsibility (including cost responsibilities) for further development and
commercialization of NicVAX. In parallel and independent of whether it exercises
its option to in-license NicVAX, GSK will be developing a next-generation
nicotine vaccine based on our intellectual property together with GSK’s own
technology.
We are
recognizing the upfront payment from GSK ratably over the period of our
performance obligations contained in the agreement, including participation on a
joint steering committee. If GSK exercises its option, we will recognize any
such option payment over the remaining period of the joint steering committee.
We recognize revenues related to the substantive milestones in the periods we
complete them.
RENs (Ring Expanded
Nucleotides). As we are now focused on the development of NicVAX, on
April 26, 2010, we terminated our agreement with the University of
Maryland.
NOTE
10 SUBSEQUENT EVENTS
Management
performed an evaluation of Company activity through the date the unaudited
condensed and consolidated financial statements were available to be issued.
Management concluded that there are no significant subsequent events requiring
disclosure.
FORWARD
LOOKING STATEMENTS
Statements
in this quarterly report that are not strictly historical are forward-looking
statements and include statements about products in development, results and
analyses of clinical trials and studies, research and development expenses, cash
expenditures, licensure applications and approvals, and alliances and
partnerships, among other matters. You can identify these forward-looking
statements because they involve our expectations, intentions, beliefs, plans,
projections, anticipations, or other characterizations of future events or
circumstances. These forward-looking statements are not guarantees of future
performance and are subject to risks and uncertainties that may cause actual
results to differ materially from those in the forward-looking statements as a
result of any number of factors. These factors include, but are not limited to,
risks relating to our ability to conduct and obtain successful results from our
two Phase III clinical trials for NicVAX; GSK’s failure to exercise its option
for and successfully commercialize NicVAX; GSK’s failure to successfully develop
and commercialize any future generation candidate nicotine vaccine utilizing our
intellectual property; our ability to commercialize NicVAX if GSK does not
exercise its option for NicVAX; our ability to raise sufficient new capital
resources to fully develop and commercialize NicVAX if GSK does not exercise the
NicVAX option; our ability to attract, retain and motivate key employees; our
ability to collect any further milestones and royalty payments under the PhosLo
and PentaStaph agreements; the ability to obtain regulatory approval for NicVAX
and any future generation candidate nicotine vaccine in the U.S. or other
markets; our ability to successfully contract with contract manufacturing
organizations for the manufacture and supply of NicVAX and the risk that these
organizations will not fulfill their obligations to us; our ability to comply
with reporting and payment obligations under government rebate and pricing
programs; and loss of full use of our net operating loss
carryforwards. Some of these factors are more fully discussed, as are
other factors, in our Annual Report on Form 10-K for the fiscal year ended
December 26, 2009 filed with the Securities and Exchange Commission. We do
not undertake to update any of these forward-looking statements or to announce
the results of any revisions to these forward-looking statements except as
required by law.
The
following is a discussion and analysis of the major factors contributing to our
financial condition and results of operations for the three- and six-month
periods ended June 26, 2010. The discussion and analysis should be read in
conjunction with the unaudited condensed consolidated financial statements and
notes thereto.
OVERVIEW
We are a
biopharmaceutical company focused on the development of vaccines addressing the
unmet medical need of nicotine addiction. We leverage our experience and
knowledge in powering the human immune system to target this serious unmet
medical need. We initiated a strategic alternatives process beginning in 2006 to
enhance shareholder value that has resulted in the sale, licensure or grant of
an option to acquire all of our marketed products and major pipeline
products. Our sole
remaining product currently in development is NicVAX® [Nicotine Conjugate Vaccine],
an innovative and proprietary investigational vaccine for treatment of nicotine
addiction and prevention of smoking relapse. In the first quarter 2010 we
granted GSK (i) an option to exclusively in-license NicVAX on a worldwide basis
and (ii) a license to develop follow-on next-generation nicotine vaccines using
our intellectual property.
Product
Development
The
smoking cessation market is estimated to exceed $4 billion annually and is
currently considered to be a largely unmet medical need. Nicotine is a
non-immunogenic small molecule that, upon inhalation into the lungs, quickly
passes into the bloodstream and subsequently reaches the brain by crossing the
blood-brain barrier. Once in the brain, the nicotine binds to specific nicotine
receptors resulting in the release of stimulants, such as dopamine, a chemical
linked to pleasure and to addiction. NicVAX is designed to stimulate the immune
system to produce antibodies that bind to nicotine in the bloodstream and
prevent it from crossing the blood-brain barrier and entering the brain. With a
reduced amount of nicotine reaching the brain, fewer stimulants are released and
the pleasurable, positive-reinforcing effects of nicotine are diminished,
thereby making it easier to quit smoking. Pre-clinical studies with NicVAX have
shown that vaccination prevents nicotine from reaching the brain and blocks the
effects of nicotine, including effects that can lead to addiction or can
reinforce and maintain addiction, in animals. In humans, NicVAX, in combination
with quit-counseling, has been clinically demonstrated to help smokers, who want
to quit, achieve long-term abstinence. We believe NicVAX may have advantages
over existing treatment therapies because the anti-nicotine antibodies limit the
ability of nicotine to enter the brain. Moreover, these anti-nicotine antibodies
persist for six to 12 months following vaccination. This is important due to the
extremely high relapse rate that has been observed in smokers who
attempt to quit smoking.
In
November 2007, we announced the successful completion of a Phase IIb
“proof-of-concept” clinical trial for NicVAX that showed statistically
significant rates of smoking cessation and continuous long-term smoking
abstinence at six and 12 months for subjects injected with NicVAX as compared
with subjects injected with placebo. In October 2008, we announced the results
of a Phase II schedule optimization immunogenicity study assessing the antibody
response and safety of a six-dose immunization schedule. This study showed that
significantly higher antibody levels can be generated earlier in a higher
percentage of subjects than in the Phase IIb proof-of-concept study and that the
revised dose regimen continued to be well tolerated. These key results have
supported the basis of our design for the NicVAX Phase III trials. In December
2008, we announced that we had reached agreement with the FDA on a SPA for the
pivotal Phase III clinical trials for NicVAX. The SPA forms the foundation to
support approval of a NDA. In June 2009, we announced that we
received Scientific Advice from the EMA which is well aligned with our SPA
agreement with the FDA regarding the design of the trial. In September 2009, we
announced that we received a $10 million grant from NIDA, to partially offset
the cost of the first of two Phase III studies that are required by the FDA to
support NicVAX’s licensure. In October 2009, we also announced the initiation of
an investigator initiated clinical trial in the Netherlands to test the efficacy
of a combined therapy of NicVAX with varenicline, or Chantix. In November 2009,
we announced the initiation of the first of two Phase III efficacy trials in the
U.S. In March 2010, we initiated the second Phase III trial and in July 2010, we
announced the completion of enrollment in the first Phase III trial. As such, we
believe that NicVAX is at a more advanced stage of development than any
potentially competing smoking cessation vaccine.
FOR
THE THREE MONTHS ENDED JUNE 26, 2010 AND JUNE 27, 2009
Revenue. Revenue was $4.8
million for the second quarter of 2010; we had no revenues in the same period in
2009. Revenue in 2010 reflects amounts recognized under the PentaStaph and
NicVAX agreements with GSK, including amortization of the upfront fees that are
being recognized as revenue ratably over the terms of the joint steering
committees created under these agreements. We also recognized $0.9 million in
the second quarter of 2010 related to services we provided to GSK under the
PentaStaph agreement. Our revenue over the remainder of 2010 will reflect
ongoing ratable recognition of upfront payments, reimbursement by GSK of costs
related to the PentaStaph trial and possible achievement of the remaining
PentaStaph milestones.
Costs of services. Costs of
services of $0.6 million represent the costs incurred by us to perform under the
PentaStaph agreement with GSK with respect to the transitional services,
including performance of the Phase I clinical trial and associated activities.
These costs include internal labor, external contractors and allocated indirect
costs. These costs will continue for the balance of 2010.
General and administrative
expenses. General and administrative expenses were $1.2 million for the
second quarter of 2010 compared to $2.4 million for the second quarter of 2009.
The decrease of $1.2 million reflects our effort to reduce expenses and lower
legal and facilities costs, and includes an allocation of a portion of these
expenses to costs of services. We expect our full-year 2010 general and
administrative expenses to be below those for fiscal 2009.
Research and development
expenses. Research and development expenses were $6.5 million for the
second quarter of 2010 compared to $3.4 million for the second quarter of 2009.
Research and development expenses increased approximately $3.1 million primarily
due to our two ongoing Phase III trials for NicVAX, and NicVAX
manufacturing-related activities. The costs incurred related to the PentaStaph
Phase I clinical trial are reimbursed by GSK (and such reimbursement is
recognized as revenue). Approximately $3.3 million of the costs for the NicVAX
trial has been offset by grant funding from NIDA and approximately $0.1 million
of the costs for PentaStaph has been offset by grant funding from the U.S.
Department of Defense (DoD). Research and development expenses are expected to
increase during the balance of 2010 as we continue work on our various clinical
trials.
FOR
THE SIX MONTHS ENDED JUNE 26, 2010 AND JUNE 27, 2009
Revenue. Revenue was $18.6
million for the first six months of 2010; we had no revenue in the comparable
period in 2009. Revenue in 2010 reflects amounts recognized under the PentaStaph
and NicVAX agreements with GSK, including amortization of the upfront fees that
are being recognized as revenue ratably over the terms of the joint steering
committees created under these agreements. In the first half of 2010 we
recognized $8.0 million of revenue related to the successful achievement of a
PentaStaph performance milestone and $1.8 million related to services provided
to GSK under the PentaStaph agreement. Revenue over the remainder of 2010 will
reflect ongoing ratable recognition of upfront payments, reimbursement by GSK of
costs related to the PentaStaph trial, and possible achievement of the remaining
PentaStaph milestones.
Costs of services. Costs of
services of $1.3 million for the first six months of 2010 represent the costs
incurred by us to perform under the PentaStaph agreement with GSK with respect
to the transitional services, including performance of the Phase I clinical
trial and associated activities. These costs include internal labor, external
contractors and allocated indirect costs. These costs will continue for the
balance of 2010.
General and administrative
expenses. General and administrative expenses were $3.0 million for the
first six months of 2010 compared to $5.4 million for the comparable 2009
period. The decrease of $2.4 million reflects our effort to reduce expenses and
lower legal and facilities costs, and includes an allocation of a portion of
these expenses to costs of services. We expect our full-year 2010 general and
administrative expenses to be below those for fiscal 2009.
Research and development
expenses. Research and development expenses were $12.4 million for the
first six months of 2010 compared to $7.2 million for the comparable 2009
period. Research and development increased approximately $5.2 million primarily
due to our two ongoing Phase III trials for NicVAX and NicVAX
manufacturing-related activities. The costs related to the PentaStaph Phase I
clinical trial are reimbursed by GSK (and such reimbursement is recognized as
revenue). Approximately $4.5 million of the costs for the NicVAX and PentaStaph
trials has been offset by grant funding from NIDA and DoD. Research and
development expenses are expected to continue to increase during the balance of
2010.
Interest expense. Interest
expense was $0.2 million for the first six months of 2010 compared to $0.5
million for the comparable 2009 period. The decrease in interest expense
reflects the impact of the repurchase of all of our Convertible Senior Notes in
the second quarter of 2010.
LIQUIDITY
AND CAPITAL RESOURCES
Our cash,
cash equivalents and marketable securities at June 26, 2010 totaled $118.0
million compared to $119.0 million at December 26, 2009. Cash provided by
operating activities was offset by payments of approximately $35.8 million for
the repurchase of our shares of common stock and $6.1 million for the repurchase
of the remaining balance of our Convertible Senior Notes, as well as our
operating expenses.
Cash
provided by operating activities from operations for the six months ended June
26, 2010 was $41.0 million, compared to cash used in operating activities of
$12.8 million for the six months ended June 27, 2009. The significant increase
in cash provided by operating activities in 2010 was primarily associated with
the $56.3 million received from GSK associated with the PentaStaph and NicVAX
agreements offset in part by cash used for general and administrative and
research and development expenses. Cash used for investing activities in 2010
was $26.0 million, consisting largely of the net purchases of our marketable
securities.
In the
first half of 2010, the Company purchased 6.7 million shares for $36.4 million
at an average price per share of $5.47. Since the inception of the program in
December 2007 through June 26, 2010, we have repurchased a total of 18.8 million
shares at a total cost of $81.3 million, at an average price of $4.33 per share.
Subsequent to the end of the second quarter, we repurchased an additional 0.6
million shares for $3.1 million, at an average price of $5.46 per share.
Approximately $30.6 million remains available for share repurchase as of July
30, 2010. The Company also used $6.1 million to repurchase the
remaining balance of its Convertible Notes during the first half of
2010.
We
believe cash, cash equivalents and marketable securities on hand at June 26,
2010 will be sufficient to meet our anticipated cash requirements for operations
for at least the next 12 months.
CRITICAL
ACCOUNTING POLICIES AND ESTIMATES
Note 2 to
our condensed consolidated financial statements includes a discussion of our
significant accounting policies. A summary of the more significant policies
follows:
Accounting estimates: The
preparation of financial statements in conformity with U.S. GAAP requires
management to make estimates and assumptions that affect the reported amounts of
assets and liabilities and disclosure of contingent assets and liabilities at
the date of the financial statements and the reported amounts of income and
expenses during the reporting period, including such amounts related to
discontinued operations. Actual results could differ from those
estimates.
Revenue
recognition: Our contracts and agreements may include multiple
elements and deliverables, including licenses, options, research and development
activities, participation on joint steering committees, and contract
manufacturing, among other elements. When we determine that an element has
stand alone value to our customer, we allocate the total contract price to that
element based on its objectively determined and relative fair value, and
recognize revenue for that element according to its characteristics. When we
cannot reliably and objectively determine fair value of any delivered element,
we combine that element with undelivered elements as a single unit of
accounting. Revenues related to substantive milestone activities are recognized
as revenue in the period such activities are completed. We analyze cost
reimbursable grants and contracts to determine whether we should report such
reimbursements as revenue or as an offset to our expenses
incurred.
Research and development expenses:
Research and development costs are expensed as incurred; advanced
payments are deferred and subsequently expensed over the period of performance.
Research and development expenses include direct labor costs as well as the
costs of contractors and other direct and indirect expenses (including an
allocation of the costs of facilities). We expense amounts payable to third
parties under collaborative product development agreements at the earlier of the
milestone achievement or as payments become contractually due.
Share-based compensation: We
currently account for share-based compensation at fair value; accordingly we
expense the estimated fair value of share-based awards made in exchange for
employee services over the requisite employee service period. Share-based
compensation cost is determined at the grant date using an option pricing model.
The value of the award that is ultimately expected to vest is recognized as
expense on a straight-line basis over the employee’s requisite service
period.
New accounting
pronouncements: There are several new accounting and disclosure
requirements that we will be required to adopt in the future, primarily with
respect to revenue recognition practices. In 2011, we will be required to adopt
new revenue recognition practices relating to revenue arrangements that include
multiple elements. Our license agreements with GSK related to our PentaStaph and
NicVAX products may be affected by the new accounting and disclosure
requirements. We are currently evaluating any potential impact these new
requirements may have on our consolidated financial statements.
Item
3. Quantitative
and Qualitative Disclosures About Market Risk
There
have been no material changes to our market risk as described in Item 7A of our
Annual Report on Form 10-K for the year ended December 26, 2009. We repurchased
all of our Convertible Senior Notes on April 15, 2010.
Our Chief
Executive Officer currently serves as acting Chief Financial
Officer.
Evaluation
of Disclosure Controls and Procedures
An
evaluation was performed under the supervision and with the participation of our
management, including our Chief Executive Officer and Chief Accounting Officer,
of the effectiveness of our disclosure controls and procedures (as defined in
Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934, as
amended) as of the end of the period covered by this report. Based on
that evaluation, the Chief Executive Officer and Chief Accounting Officer
concluded that these disclosure controls and procedures were
effective.
Changes
in Internal Controls Over Financial Reporting
There has
been no change in our internal control over financial reporting during our most
recent fiscal quarter that has materially affected, or is reasonably likely to
materially affect, our internal control over financial reporting.
A control
system, no matter how well designed and operated, can provide only reasonable,
not absolute, assurance that the objectives of the control system are met, and
therefore, no evaluation of controls can provide absolute assurance that all
control issues and instances of fraud, if any, within the Company have been
detected. We do not expect that our disclosure controls and procedures or our
internal control over financial reporting are able to prevent with certainty all
errors and all fraud.
We are
parties to legal proceedings that we believe to be ordinary, routine litigation
incidental to the business of present or former operations. It is management’s
opinion, based on the advice of counsel, that the ultimate resolution of such
litigation will not have a material adverse effect on our financial condition,
results of operations or cash flows.
There
have been no material changes to the Risk Factors contained in Item 1A of our
Annual Report on Form 10-K for the year ended December 26, 2009.
Item 2. Unregistered
Sales of Equity Securities and Use of Proceeds
We had no
unregistered sales of equity securities in the first and second quarters of
2010. The following table presents our stock repurchase program during the
quarter.
Approximate Dollar
|
||||||||||||||||
Total Number of
|
Value of Shares that
|
|||||||||||||||
Shares Purchased as
|
May
Yet Be
|
|||||||||||||||
Total Number of
|
Average Price Paid
|
Part
of Publicly
|
Purchased Under the
|
|||||||||||||
Period
|
Shares Purchased
|
per
Share
|
Announced Program
|
Program
|
||||||||||||
Month
#4 (March 28, 2010 through May 1, 2010)
|
3,640,670 | $ | 5.67 | 3,640,670 | $ | 40.3 million | ||||||||||
Month
#5 (May 2, 2010 through May 29, 2010)
|
847,493 | $ | 5.51 | 847,493 | $ | 35.6 million | ||||||||||
Month
#6 (May 30, 2010 through June 26, 2010)
|
348,216 | $ | 5.47 | 348,216 | $ | 33.7 million | ||||||||||
Total
|
4,836,379 | $ | 5.63 | 4,836,379 | $ | 33.7 million |
Starting
in December 2007, our Board of Directors approved the buyback of up to $115
million of our common stock in the open market or in privately negotiated
transactions. There is no expiration date for this repurchase program. Since the
inception of the program through June 26, 2010, we have repurchased a total of
18.8 million shares at a total cost of $81.3 million, at an average price of
$4.33 per share. Subsequent to the end of the second quarter through July 30,
2010, we have repurchased an additional 0.6 million shares for $3.1
million.
None
31 Rule
13a-14(a)/15d-14(a) Certification.
32 Section
1350 Certification.
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has
duly caused this report to be signed on its behalf by the undersigned thereunto
duly authorized.
Nabi
Biopharmaceuticals
|
||||
Date:
August 5, 2010
|
By:
|
/s/
Raafat E.F. Fahim, Ph.D.
|
||
Raafat
E.F. Fahim, Ph.D.
|
||||
President,
Chief Executive Officer and acting Chief Financial
Officer
|
||||
By:
|
/s/
Ronald B. Kocak
|
|||
Corporate
Controller and Chief Accounting
Officer
|
EXHIBIT
INDEX
Exhibit
|
|
Description
|
31
|
|
Rule
13a-14(a)/15d-14(a) Certification.
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32
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|
Section
1350 Certification.
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19