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Table of Contents
ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
PART IV
Table of Contents
UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
(Mark One)
FORM 10-K
☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT
OF 1934
For the fiscal year ended December 31, 2011
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 No. 0-30319
THERAVANCE, INC.
(Exact name of registrant as specified in its charter)
Delaware
(State or other jurisdiction of incorporation or
organization)
94-3265960
(I.R.S. Employer Identification No.)
901 Gateway Boulevard,
South San Francisco, California
(Address of principal executive
offices)
94080
(Zip Code)
Registrant's telephone number, including area code: 650-808-6000
SECURITIES REGISTERED PURSUANT TO SECTION 12(b) OF THE ACT:
Title of Each Class
Common Stock $0.01 Par Value
Name of Each Exchange On Which
Registered
Nasdaq Global Market
SECURITIES REGISTERED PURSUANT TO SECTION 12(g) OF THE ACT: NONE
Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☒ No o
Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or Section 15(d) of the Act. Yes o No ☒
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 ☒ No o
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 205
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 o
Indicate by check mark if disclosure of delinquent filers pursuant to Item 405 of Regulation S-K (§ 229.405) is not contained herein, and will not be contained, to the best of registrant's knowledge, in
definitive proxy or information statements incorporated by reference in Part III of this Form 10-K or any amendment to this Form 10-K. ☒
Indicate by check mark whether registrant is a large accelerated filer, an accelerated filer or a non-accelerated filer. See definition of "accelerated filer and large accelerated filer" in Rule 12b-2 of the
Exchange Act (Check One):
Large accelerated filer ☒
Accelerated filer o
Non-accelerated filer o
(Do not check if a
smaller reporting company)
Smaller reporting company o
Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No ☒
The aggregate market value of the voting and non-voting common equity held by non-affiliates of the registrant based upon the closing price of the Common Stock on the Nasdaq Global Market on
June 30, 2011 was $961,098,794.
On February 17, 2012, there were 86,149,162 shares of the registrant's Common Stock outstanding.
DOCUMENTS INCORPORATED BY REFERENCE
Specified portions of the registrant's definitive Proxy Statement to be issued in conjunction with the registrant's 2012 Annual Meeting of Stockholders, which is expected to be filed not later than 120 days
after the registrant's fiscal year ended December 31, 2011, are incorporated by reference into Part III of this Annual Report. Except as expressly incorporated by reference, the registrant's Proxy Statement shall
not be deemed to be a part of this Annual Report on Form 10-K.
Table of Contents
THERAVANCE, INC.
2011 Form 10-K Annual Report
Table of Contents
PART I
Item 1.
Item 1A.
Item 1B.
Item 2.
Item 3.
Item 4.
Business
Risk Factors
Unresolved Staff Comments
Properties
Legal Proceedings
Mine Safety Disclosures
Item 5.
PART II
Market for the Registrant's Common Equity, Related Stockholder Matters and Issuer Purchases of Equity
Securities
Item 6.
Item 7.
Item 7A.
Item 8.
Item 9.
Item 9A.
Item 9B.
Selected Financial Data
Management's Discussion and Analysis of Financial Condition and Results of Operations
Quantitative and Qualitative Disclosures About Market Risk
Financial Statements and Supplementary Data
Changes in and Disagreements With Accountants on Accounting and Financial Disclosure
Controls and Procedures
Other Information
Item 10.
Item 11.
Item 12.
Item 13.
Item 14.
PART III
Directors, Executive Officers and Corporate Governance
Executive Compensation
Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters
Certain Relationships and Related Transactions, and Director Independence
Principal Accounting Fees and Services
Exhibits and Financial Statement Schedules
Item 15.
Signatures
Exhibits
PART IV
2
3
15
34
34
34
34
35
38
39
55
56
89
89
92
92
92
92
92
92
93
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Special Note regarding Forward-Looking Statements
This Annual Report on Form 10-K contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and
Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements involve substantial risks, uncertainties and assumptions. All
statements in this Annual Report on Form 10-K, other than statements of historical facts, including statements regarding our strategy, future operations, future
financial position, future revenues, projected costs, prospects, plans, intentions, expectations and objectives could be forward-looking statements. The words
"anticipates," "believes," "designed," "estimates," "expects," "goal," "intends," "may," "plans," "projects," "pursuing," "will," "would" and similar expressions
(including the negatives thereof) are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words.
We may not actually achieve the plans, intentions, expectations or objectives disclosed in our forward-looking statements and the assumptions underlying our
forward-looking statements may prove incorrect. Therefore, you should not place undue reliance on our forward-looking statements. Actual results or events
could differ materially from the plans, intentions, expectations and objectives disclosed in the forward-looking statements that we make. Factors that we believe
could cause actual results or events to differ materially from our forward-looking statements include, but are not limited to, those discussed below in "Risk
Factors" in Item 1A, "Management's Discussion and Analysis of Financial Condition and Results of Operations" in Item 7 and elsewhere in this Annual Report
on Form 10-K. Our forward-looking statements in this Annual Report on Form 10-K are based on current expectations and we do not assume any obligation to
update any forward-looking statements.
ITEM 1. BUSINESS
Overview
PART I
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical
companies. We are focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including
respiratory disease, bacterial infections, and central nervous system (CNS)/pain. Our key programs include: RELOVAIR™, LAMA/LABA ('719/vilanterol (VI))
and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc (GSK), and our oral Peripheral Mu Opioid Receptor
Antagonist (PµMA) program. By leveraging our proprietary insight of multivalency to drug discovery, we are pursuing a best-in-class strategy designed to
discover superior medicines in areas of significant unmet medical need. Our headquarters are located at 901 Gateway Boulevard, South San Francisco, California
94080. Theravance was incorporated in Delaware in November 1996 under the name Advanced Medicine, Inc. and began operations in May 1997. The Company
changed its name to Theravance, Inc. in April 2002.
Our strategy focuses on the discovery, development and commercialization of medicines with superior efficacy, convenience, tolerability and/or safety. Our
proprietary approach combines chemistry and biology to discover new product candidates using our expertise in multivalency. Multivalency refers to the
simultaneous attachment of a single molecule to multiple binding sites on one or more biological targets. When compared to monovalency, whereby a molecule
attaches to only one binding site, multivalency can significantly increase a compound's potency, duration of action and/or selectivity. Multivalent compounds
generally consist of several individual small molecules, at least one of which is biologically active when bound to its target, joined by linking components. In
addition, we believe that we can enhance the probability of successfully developing and commercializing medicines by identifying at least two structurally
different product candidates, whenever practicable, in each therapeutic program.
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In total, our research and development expenses, including stock-based compensation expense, incurred for all of our therapeutic programs in 2011, 2010,
and 2009 were $103.5 million, $75.1 million and $77.5 million, respectively.
We have entered into the following respiratory collaboration arrangements with GSK:
In November 2002, we entered into our long-acting beta2 agonist (LABA) collaboration with GSK to develop and commercialize once-daily LABA products
for the treatment of chronic obstructive pulmonary disease (COPD) and asthma. For the treatment of COPD, the collaboration is developing combination
products, RELOVAIR™ and the LAMA/LABA '719/VI. For the treatment of asthma, the collaboration is developing RELOVAIR™. RELOVAIR™ is an
investigational once-daily inhaled corticosteroid (ICS)/LABA combination treatment, comprising fluticasone furoate and vilanterol (FF/VI). '719/VI is an
investigational once-daily combination medicine consisting of the long-acting muscarinic antagonist (LAMA) GSK573719 ('719) and the LABA, VI.
In March 2004, we entered into our strategic alliance agreement with GSK under which GSK received an option to license certain of our discovery programs
on pre-determined terms and on an exclusive, worldwide basis. In 2005, GSK licensed our MABA program under this agreement and in October 2011, we and
GSK expanded the MABA program by adding six additional Theravance-discovered preclinical MABA compounds.
Astellas Pharma Inc. (Astellas) recently exercised its right to terminate our 2005 collaboration arrangement for the development and commercialization of
VIBATIV® (telavancin), a bactericidal, once-daily injectable antibiotic developed by us for the treatment of Gram-positive infections, including methicillin-
resistant Staphylococcus aureus. The U.S. Food and Drug Administration (FDA) has approved VIBATIV® for the treatment of complicated skin and skin
structure infections (cSSSI) caused by susceptible Gram-positive bacteria, including both methicillin-resistant (MRSA) and methicillin-susceptible (MSSA)
strains of Staphylococcus aureus, in adult patients. VIBATIV® is also approved in Canada for the treatment of cSSSI in adult patients. In September 2011, the
European Commission granted marketing authorization for VIBATIV® for the treatment of adults with nosocomial pneumonia, including ventilator-associated
pneumonia, known or suspected to be caused by MRSA when other alternatives are not suitable. However, in February 2012 the Committee for Medicinal
Products for Human Use (CHMP) recommended to the European Commission that it suspend this marketing authorization because the single-source VIBATIV®
drug product supplier does not meet the Good Manufacturing Practice (GMP) requirements to allow the manufacture of VIBATIV®. We currently are focused on
evaluating commercialization alternatives for VIBATIV®, including re-partnering, and re-establishing consistent VIBATIV® product supply. Due to the
supplier's manufacturing issues, VIBATIV® is currently subject to critical product shortages and regional supply outages in the U.S. If the issues at the
manufacturer are not promptly resolved, obtaining supply would require identifying and qualifying an alternative manufacturer, which could take 12 to
24 months.
Our Programs
Our drug discovery efforts are based on the principles of multivalency. Multivalency involves the simultaneous attachment of a single molecule to multiple
binding sites on one or more biological targets. We have applied our expertise in multivalency to discover product candidates and lead compounds in a wide
variety of therapeutic areas. We have conducted extensive research in both relevant laboratory and animal models to demonstrate that by applying the design
principles of multivalency, we can achieve significantly stronger and more selective attachment of our compounds to a variety of intended biological targets. We
believe that medicines that attach more strongly and selectively to their targets will be superior to many medicines by substantially improving potency, duration of
action and/or safety.
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Prior to entering into human clinical studies, a product candidate undergoes preclinical studies which include formulation development or safety testing in
animal models. The table below summarizes the status of our most advanced product candidates for internal development or co-development.
Key:
•
•
•
•
•
•
•
•
•
•
•
ADHD: Attention Deficit Hyperactivity Disorder
CNS: Central Nervous System
COPD: Chronic Obstructive Pulmonary Disease
GI: Gastrointestinal
GP-Ceph: Glycopeptide-Cephalosporin
ICS: Inhaled Corticosteroid
LABA: Long-Acting Beta2 Agonist
LAMA: Long-Acting Muscarinic Antagonist
MABA: Bifunctional Muscarinic Antagonist-Beta2 Agonist
MARIN: Monoamine Reuptake Inhibitor
PµMA: Peripheral Mu Opioid Receptor Antagonist
In the table above:
•
Development Status indicates the most advanced stage of development that has been completed or is in process.
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•
•
•
•
•
Phase 1 indicates initial clinical safety testing in healthy volunteers, or studies directed toward understanding the mechanisms of action of the
drug.
Phase 2 indicates further clinical safety testing and preliminary efficacy testing in a limited patient population.
Phase 3 indicates evaluation of clinical efficacy and safety within an expanded patient population.
Filed indicates that a New Drug Application or European Marketing Authorization Application has been submitted to and accepted for filing by
the FDA or European Medicines Agency, respectively.
We consider programs in which at least one compound has successfully completed a Phase 2a study showing efficacy and tolerability as having
achieved Proof-of-Concept.
Our Relationship with GlaxoSmithKline
LABA collaboration with GSK
In November 2002, we entered into our LABA collaboration with GSK to develop and commercialize once-daily LABA products for the treatment of COPD
and asthma. For the treatment of COPD, the collaboration is developing combination products, RELOVAIR™ and the LAMA/LABA '719/VI. For the treatment
of asthma, the collaboration is developing RELOVAIR™. RELOVAIR™ is an investigational once-daily combination medicine consisting of a LABA, VI,
previously referred to as GW642444 or '444, and an ICS, fluticasone furoate (FF). The LAMA/LABA, '719/VI, is an investigational once-daily combination
medicine consisting of the LAMA, '719, and the LABA, VI. The RELOVAIR™ program is aimed at developing a once-daily combination LABA/ICS to succeed
GSK's Advair®/Seretide™ (salmeterol and fluticasone as a combination) franchise, which reported 2011 sales of approximately $8.1 billion, and to compete with
Symbicort® (formoterol and budesonide as a combination), which reported 2011 sales of approximately $3.1 billion. '719/VI, which is also a combination
product, is targeted as an alternative treatment option to Spiriva® (tiotropium), a once-daily, single-mechanism bronchodilator, which reported 2010 sales of
approximately $3.8 billion.
The current lead product candidates in the LABA collaboration, VI and FF, were discovered by GSK. In the event that VI is successfully developed and
commercialized, we will be obligated to make milestone payments to GSK which could total as much as $220.0 million if both a single-agent and a combination
product or two different combination products are launched in multiple regions of the world. If global regulatory authorities accept the applications for
RELOVAIR™, which we anticipate will be filed by GSK beginning in mid-2012, a portion of these potential milestone payments could be payable to GSK within
the next two years. We are entitled to annual royalties from GSK of 15% on the first $3.0 billion of annual global net sales and 5% for all annual global net sales
above $3.0 billion. Sales of single-agent LABA medicines and combination medicines would be combined for the purposes of this royalty calculation. For other
products combined with a LABA from the LABA collaboration, such as '719/VI, royalties are upward tiering and range from the mid-single digits to 10%.
However, if GSK is not selling a LABA/ICS combination product at the time that the first other LABA combination is launched, then the royalties described
above for the LABA/ICS combination medicine would be applicable.
In connection with the LABA collaboration, in 2002, Glaxo Group Limited, an affiliate of GSK, purchased shares of our Series E preferred stock for an
aggregate purchase price of $40.0 million.
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2004 Strategic Alliance with GSK
In March 2004, we entered into our strategic alliance with GSK. Under this alliance, GSK received an option to license exclusive development and
commercialization rights to product candidates from certain of our discovery programs on pre-determined terms and on an exclusive, worldwide basis. Upon
GSK's decision to license a program, GSK is responsible for funding all future development, manufacturing and commercialization activities for product
candidates in that program. In addition, GSK is obligated to use diligent efforts to develop and commercialize product candidates from any program that it
licenses. If the program is successfully advanced through development by GSK, we are entitled to receive clinical, regulatory and commercial milestone
payments and royalties on any sales of medicines developed from the program. If GSK chooses not to license a program, we retain all rights to the program and
may continue the program alone or with a third party.
In 2005, GSK licensed our MABA program for the treatment of COPD, and in October 2011, we and GSK expanded the MABA program by adding six
additional Theravance-discovered preclinical MABA compounds (the "Additional MABAs"). GSK's development, commercialization, milestone and royalty
obligations under the strategic alliance remain the same with respect to '081, the lead compound in the MABA program. GSK is obligated to use diligent efforts to
develop and commercialize at least one MABA within the MABA program, but may terminate progression of any or all Additional MABAs at any time and
return them to us, at which point we may develop and commercialize such Additional MABAs alone or with a third party. Both GSK and we have agreed not to
conduct any MABA clinical studies outside of the strategic alliance so long as GSK is in possession of the Additional MABAs. If a single-agent MABA medicine
containing '081 is successfully developed and commercialized, we are entitled to receive royalties from GSK of between 10% and 20% of annual global net sales
up to $3.5 billion, and 7.5% for all annual global net sales above $3.5 billion. If a MABA medicine containing '081 is commercialized only as a combination
product, such as a MABA/ICS, the royalty rate is 70% of the rate applicable to sales of the single-agent MABA medicine. For single-agent MABA medicines
containing an Additional MABA, we are entitled to receive royalties from GSK of between 10% and 15% of annual global net sales up to $3.5 billion, and 10%
for all annual global net sales above $3.5 billion. For combination products containing an Additional MABA, such as a MABA/ICS, the royalty rate is 50% of the
rate applicable to sales of the single-agent MABA medicine. If a MABA medicine containing '081 is successfully developed and commercialized in multiple
regions of the world, we could earn total milestone payments up to $125.0 million for a single-agent medicine and up to $250.0 million for both a single-agent
and a combination medicine. If a MABA medicine containing an Additional MABA is successfully developed and commercialized in multiple regions of the
world, we could earn total milestone payments up to $129.0 million.
In connection with the expansion of the MABA program, GSK relinquished its option right on our MonoAmine Reuptake Inhibitor (MARIN) program and
Angiotensin Receptor-NEP Inhibitor (ARNI) program. GSK has no further option rights on any of our research or development programs under the strategic
alliance.
In May 2004, GlaxoSmithKline LLC, an affiliate of GSK, purchased 6,387,096 shares of our Class A common stock for an aggregate purchase price of
$108.9 million and, upon the closing of our initial public offering on October 8, 2004, GlaxoSmithKline LLC purchased an additional 433,757 shares of Class A
common stock for an aggregate purchase price of $6.9 million. In November 2010 Glaxo Group Limited, an affiliate of GSK, purchased 5,750,000 shares of our
Common Stock for an aggregate purchase price of $129.4 million.
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GSK Conversion of our Class A Common Stock and Purchases of Common Stock under our Governance Agreement with GSK
In July 2011, GSK converted all of the shares of our Class A common stock held by its affiliates into 9,401,499 shares of our common stock on a one share-
for-one share basis in accordance with the terms of our restated certificate of incorporation. In addition, Glaxo Group Limited purchased shares of our common
stock pursuant to its periodic "top-up" rights under our governance agreement with GSK dated June 4, 2004, as amended, as follows:
Purchase dates
February 24, 2011
May 3, 2011
August 2, 2011
November 1, 2011
Program Highlights
Respiratory Programs with GSK
RELOVAIR™
Through December 31, 2011
Common Stock
Shares Purchased
Aggregate Amounts
(in thousands)
152,278 $
261,299 $
102,466 $
58,411 $
3,609
6,689
2,020
1,298
RELOVAIR™ is an investigational once-daily ICS/LABA combination treatment, comprising FF/VI, currently in development for the treatment of patients
with COPD or asthma.
In January 2012, we and GSK announced that GSK intends to commence global regulatory filings in COPD and asthma beginning in mid-2012 based upon
the initial outcomes from pivotal Phase 3 studies for once-daily RELOVAIR™ in COPD and asthma. For asthma, GSK will continue discussions with the FDA
on the regulatory requirements for a U.S. asthma indication.
LAMA/LABA Combination (GSK573719/Vilanterol or '719/VI)
Enrollment is complete for the seven ongoing studies in the Phase 3 program for the once-daily LAMA/LABA dual bronchodilator '719/VI. '719/VI
combines two bronchodilators currently under development—'719, a LAMA and VI, a LABA. These two molecules provide two mechanisms of bronchodilation
for patients with COPD: antagonism of acetylcholine muscarinic receptors and agonism of beta2 adrenoreceptors.
The LAMA/LABA Phase 3 program, which will evaluate over 5,000 patients with COPD globally, consists of a 52-week study to evaluate the long term
safety and tolerability of '719 (125mcg) alone, as well as the combination '719/VI (125/25mcg), two large 6-month pivotal studies that will compare
improvements in lung function between '719/VI, its components and placebo, two 6-month studies to compare the combination with its components and
tiotropium and two studies to assess the effect of '719/VI on exercise endurance. The Phase 3 program will investigate two doses of '719 (125mcg and 62.5mcg)
and two doses of the combination '719/VI (125/25mcg and 62.5/25mcg).
Inhaled Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA)
GSK961081 ('081), the lead compound in the MABA program with GSK, is a single molecule bifunctional bronchodilator with both muscarinic antagonist
and beta2 receptor agonist activity. In February 2012, we announced topline results from a Phase 2b COPD study with '081.
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In October 2011, we and GSK amended the 2004 Strategic Alliance Agreement to expand the MABA program. We granted to GSK an exclusive license to
develop and commercialize additional preclinical MABA compounds discovered by Theravance. We received an upfront license payment of $1.0 million and
have the potential to receive clinical, regulatory and commercial milestone payments as well as royalties on worldwide net sales if one of these MABA
compounds is successfully commercialized. In connection with this amendment, we regained full rights to our MonoAmine Reuptake INhibitor (MARIN)
program, which is currently in Phase 2 development, and our Angiotensin Receptor-NEP Inhibitor (ARNI) program in preclinical development.
Bacterial Infections Program
VIBATIV® (telavancin) for injection
On January 6, 2012, Astellas exercised its right to terminate our VIBATIV® collaboration agreement and we regained full global rights to VIBATIV®, our
once-daily injectable lipoglycopeptide antibiotic approved in the U.S. and Canada. We currently are focusing our efforts on evaluating commercialization
alternatives for VIBATIV®, including re-partnering, and re-establishing consistent VIBATIV® product supply.
Central Nervous System (CNS)/Pain Program
Oral Peripheral Mu Opioid Receptor Antagonist (PµMA)—TD-1211
Enrollment is progressing in the Phase 2b program, which will assess the safety, tolerability and clinical activity of TD-1211 in patients with opioid-induced
constipation. This program is evaluating several doses and dose regimens to provide information for the design of the Phase 3 program. TD-1211 is an
investigational once-daily, orally-administered, peripherally selective, multivalent inhibitor of the mu opioid receptor designed to alleviate gastrointestinal side
effects of opioid therapy without affecting analgesia.
MonoAmine Reuptake INhibitor (MARIN)—TD-9855
In December 2011, we announced the initiation of an Attention-Deficit/Hyperactivity Disorder (ADHD) Phase 2 proof-of-concept study with TD-9855, the
lead compound in our MARIN program. This Phase 2 study will evaluate the safety and efficacy of two different doses of TD-9855 in adult male patients with
ADHD. TD-9855 is an investigational norepinephrine and serotonin reuptake inhibitor (NSRI) discovered by Theravance for the treatment of CNS conditions
such as ADHD and chronic pain.
Theravance Respiratory Program
Long-Acting Muscarinic Antagonist (LAMA)—TD-4208
In November 2011, we announced positive topline results from a Phase 2a single-dose COPD study of TD-4208, an investigational inhaled LAMA,
discovered by Theravance. In this study, TD-4208 met the primary endpoint by demonstrating a statistically significant mean change from baseline in peak forced
expiratory volume in one second (FEV1) compared to placebo, and was generally well tolerated.
Other Programs
In addition to the programs listed above, we have other clinical-stage programs for bacterial infections, cognitive disorders and gastrointestinal motility.
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TD-1792 is our investigational heterodimer antibiotic that combines the antibacterial activities of a glycopeptide and a beta-lactam in one molecule. The goal
of our program with TD-1792 is to develop a next-generation antibiotic for the treatment of serious infections caused by Gram-positive bacteria.
In cognitive disorders, we are evaluating compound TD-5108 as a potential treatment for Alzheimer's disease. TD-5108 has successfully completed a
Phase 1 study assessing CNS penetration. Our Gastrointestinal (GI) Motility Dysfunction program is dedicated to finding new medicines for GI motility disorders
such as chronic idiopathic constipation (CIC) and other disorders related to reduced gastrointestinal motility. Our lead compound in this area is TD-5108, a highly
selective 5-HT4 receptor agonist that has successfully completed a 400 patient Phase 2 proof-of-concept study in CIC. The back-up compound in this program,
TD-8954, has completed single-ascending and multiple-ascending dose Phase 1 studies.
Multivalency
Our proprietary approach combines chemistry and biology to discover new product candidates using our expertise in multivalency. Multivalency refers to the
simultaneous attachment of a single molecule to multiple binding sites on one or more biological targets. When compared to monovalency, whereby a molecule
attaches to only one binding site, multivalency can significantly increase a compound's potency, duration of action and/or selectivity. Multivalent compounds
generally consist of several individual small molecules, at least one of which is biologically active when bound to its target, joined by linking components.
Our approach is based on an integration of the following insights:
many targets have multiple binding sites and/or exist in clusters with similar or different targets;
biological targets with multiple binding sites and/or those that exist in clusters lend themselves to multivalent drug design;
molecules that simultaneously attach to multiple binding sites can exhibit considerably greater potency, duration of action and/or selectivity than
molecules that attach to only one binding site; and
greater potency, duration of action and/or selectivity provides the basis for superior therapeutic effects, including enhanced convenience,
tolerability and/or safety compared to conventional drugs.
•
•
•
•
Our Strategy
Our objective is to discover, develop and commercialize new medicines with superior efficacy, convenience, tolerability and/or safety. The key elements of
our strategy are to:
Apply our expertise in multivalency to discover and develop superior medicines in areas of significant unmet medical need. We intend to continue to
concentrate our efforts on discovering and developing product candidates where:
•
•
•
existing drugs have levels of efficacy, convenience, tolerability and/or safety that are insufficient to meet an important medical need;
we believe our expertise in multivalency can be applied to create superior product candidates that are more potent, longer acting and/or more
selective than currently available medicines;
there are established animal models that can be used to provide us with evidence as to whether our product candidates have the potential to
provide superior therapeutic benefits relative to current medicines; and
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•
there is a relatively large commercial opportunity.
Identify two structurally different product candidates in each therapeutic program whenever practicable. We believe that we can increase the likelihood of
successfully bringing superior medicines to market by identifying, whenever practicable, two product candidates for development in each program. Our second
product candidates are typically in a different structural class from the first product candidate. Applying this strategy can reduce our dependence on any one
product candidate and provide us with the potential opportunity to commercialize two compounds in a given area.
Partner with leading pharmaceutical companies. Our strategy is to seek collaborations with leading pharmaceutical companies to accelerate development
and commercialization of our product candidates at the strategically appropriate time. The LABA collaboration and our strategic alliance with GSK are examples
of these types of partnerships.
Leverage the extensive experience of our people. We have an experienced senior management team with many years of experience discovering,
developing and commercializing new medicines with companies such as Bristol-Myers Squibb Company, Gilead Sciences, Merck & Co. and Pfizer.
Improve, expand and protect our technical capabilities. We have created a substantial body of know-how and trade secrets in the application of our
multivalent approach to drug discovery. We believe this is a significant asset that distinguishes us from our competitors. We expect to continue to make
substantial investments in drug discovery using multivalency and other technologies to maintain what we believe are our competitive advantages.
Manufacturing
Though we have limited in-house active pharmaceutical ingredient (API) production capabilities, we rely primarily on a number of third parties, including
contract manufacturing organizations and our collaborative partners, to produce our active pharmaceutical ingredient and drug product. Manufacturing of
compounds in the RELOVAIR™, '719/VI, and MABA programs is handled by GSK, and we are now responsible for manufacture of VIBATIV® as a result of the
termination of the VIBATIV® collaboration agreement with Astellas.
We believe that we have in-house expertise to manage a network of third-party manufacturers. We believe that we will be able to continue to negotiate third-
party manufacturing arrangements on commercially reasonable terms and that it will not be necessary for us to obtain internal manufacturing capacity in order to
develop or commercialize our products. However, if we are unable to obtain contract manufacturing or obtain such manufacturing on commercially reasonable
terms, or if manufacturing is interrupted at one of our suppliers, whether due to regulatory or other reasons, we may not be able to develop or commercialize our
products as planned. Due to manufacturing issues at the single-source supplier of VIBATIV® drug product, VIBATIV® is currently subject to critical product
shortages and regional supply outages in the U.S. If the issues at the manufacturer are not promptly resolved, obtaining supply would require identifying and
qualifying an alternative manufacturer, which could take 12 to 24 months.
Government Regulation
The development and commercialization of our product candidates and our ongoing research are subject to extensive regulation by governmental authorities
in the United States and other countries. Before marketing in the United States, any medicine we develop must undergo rigorous preclinical studies and clinical
studies and an extensive regulatory approval process implemented by the FDA under the Federal Food, Drug, and Cosmetic Act. Outside the United States, our
ability to market a product depends upon receiving a marketing authorization from the appropriate regulatory authorities. The requirements governing the conduct
of clinical studies, marketing authorization, pricing and
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reimbursement vary widely from country to country. In any country, however, we will be permitted to commercialize our medicines only if the appropriate
regulatory authority is satisfied that we have presented adequate evidence of the safety, quality and efficacy of our medicines.
Before commencing clinical studies in humans in the United States, we must submit to the FDA an Investigational New Drug application that includes,
among other things, the results of preclinical studies. If the FDA accepts the Investigational New Drug submission, clinical studies are usually conducted in three
phases and under FDA oversight. These phases generally include the following:
Phase 1. The product candidate is introduced into healthy human volunteers and is tested for safety, dose tolerance and pharmacokinetics.
Phase 2. The product candidate is introduced into a limited patient population to assess the efficacy of the drug in specific, targeted indications, assess
dosage tolerance and optimal dosage, and identify possible adverse effects and safety risks.
Phase 3. If a compound is found to be potentially effective and to have an acceptable safety profile in Phase 2 evaluations, the clinical study will be
expanded to further demonstrate clinical efficacy, optimal dosage and safety within an expanded patient population.
The results of product development, preclinical studies and clinical studies must be submitted to the FDA as part of a new drug application, or NDA. The
NDA also must contain extensive manufacturing information. NDAs for new chemical entities are subject to performance goals defined in the Prescription Drug
User Fee Act (PDUFA) which suggests a goal for FDA action within 6 months for applications that are granted priority review and 10 months for applications
that receive standard review. For a product candidate no active ingredient of which has been previously approved by the FDA, the FDA must either refer the
product candidate to an advisory committee for review or provide in the action letter on the application for the product candidate a summary of the reasons why
the product candidate was not referred to an advisory committee prior to approval. In addition, under the 2009 Food and Drug Administration Amendments Act,
the FDA has authority to require submission of a formal Risk Evaluation and Management Strategy (REMS) to ensure safe use of the product. At the end of the
review period, the FDA communicates an approval of the NDA or issues a complete response listing the application's deficiencies.
Once approved, the FDA may withdraw the product approval if compliance with pre- and post-marketing regulatory standards is not maintained or if safety
or quality issues are identified after the product reaches the marketplace. In addition, the FDA may require post-marketing studies, referred to as Phase 4 studies,
to monitor the effect of approved products, and may limit further marketing of the product based on the results of these post-marketing studies. The FDA has
broad post-market regulatory and enforcement powers, including the ability to suspend or delay issuance of approvals, seize products, withdraw approvals, enjoin
violations, and institute criminal prosecution.
If we obtain regulatory approval for a medicine, this clearance to market the product will be limited to those diseases and conditions for which the medicine
is effective, as demonstrated through clinical studies and included in the medicine's labeling. Even if this regulatory approval is obtained, a marketed medicine, its
manufacturer and its manufacturing facilities are subject to continual review and periodic inspections by the FDA. The FDA ensures the quality of approved
medicines by carefully monitoring manufacturers' compliance with its current Good Manufacturing Practice (cGMP) regulations. The cGMP regulations for drugs
contain minimum requirements for the methods, facilities, and controls used in manufacturing, processing, and packing of a medicine. The regulations are
intended to make sure that a medicine is safe for use, and that it has the ingredients and strength it claims to have. Discovery of previously unknown problems
with a medicine, manufacturer or facility may result in restrictions on the medicine or manufacturer, including costly recalls or withdrawal of the medicine from
the market.
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We are also subject to various laws and regulations regarding laboratory practices, the experimental use of animals and the use and disposal of hazardous or
potentially hazardous substances in connection with our research. In each of these areas, as above, the FDA and other regulatory authorities have broad regulatory
and enforcement powers, including the ability to suspend or delay issuance of approvals, seize products, withdraw approvals, enjoin violations, and institute
criminal prosecution, any one or more of which could have a material adverse effect upon our business, financial condition and results of operations.
Outside the United States our ability to market our products will also depend on receiving marketing authorizations from the appropriate regulatory
authorities. Risks similar to those associated with FDA approval described above exist with the regulatory approval processes in other countries.
Patents and Proprietary Rights
We will be able to protect our technology from unauthorized use by third parties only to the extent that our technology is covered by valid and enforceable
patents or is effectively maintained as trade secrets. Our success in the future will depend in part on obtaining patent protection for our product candidates.
Accordingly, patents and other proprietary rights are essential elements of our business. Our policy is to seek in the United States and selected foreign countries
patent protection for novel technologies and compositions of matter that are commercially important to the development of our business. For proprietary know-
how that is not patentable, processes for which patents are difficult to enforce and any other elements of our drug discovery process that involve proprietary
know-how and technology that is not covered by patent applications, we rely on trade secret protection and confidentiality agreements to protect our interests. We
require all of our employees, consultants and advisors to enter into confidentiality agreements. Where it is necessary to share our proprietary information or data
with outside parties, our policy is to make available only that information and data required to accomplish the desired purpose and only pursuant to a duty of
confidentiality on the part of those parties.
As of December 31, 2011, we owned 271 issued United States patents and 907 granted foreign patents, as well as additional pending United States patent
applications and foreign patent applications. The claims in these various patents and patent applications are directed to compositions of matter, including claims
covering product candidates, lead compounds and key intermediates, pharmaceutical compositions, methods of use and processes for making our compounds
along with methods of design, synthesis, selection and use relevant to multivalency in general and to our research and development programs in particular. In
particular, we own the following U.S. patents which are listed in the FDA Approved Drug Products with Therapeutic Equivalence Evaluations (Orange Book) for
telavancin: U.S. Patent No. 6,635,618 B2, expiring on September 22, 2021; U.S. Patent No. 6,858,584 B2, expiring on August 24, 2022; U.S. Patent
No. 6,872,701 B2, expiring on June 5, 2021; U.S. Patent No. 7,008,923 B2, expiring on May 6, 2021; U.S. Patent No. 7,208,471 B2, expiring on May 1, 2021;
U.S. Patent No. 7,351,691 B2, expiring on May 1, 2021; U.S. Patent No. 7,531,623 B2, expiring on January 1, 2027; U.S. Patent No. 7,544,364 B2, expiring on
May 1, 2021; and U.S. Patent No. 7,700,550 B2, expiring on May 1, 2021. On October 15, 2010, we filed patent term extension (PTE) applications in the United
States Patent and Trademark Office (USPTO) for U.S. Patent Nos. 6,635,618 B2; 6,872,701 B2; and 7,208,471 B2. These PTE applications are currently pending
and if granted, we will be permitted to extend the term of one of these patents for the period determined by the USPTO.
United States issued patents and foreign patents generally expire 20 years after filing. The patent rights relating to telavancin owned by us currently consist
of United States patents that expire between 2019 and 2027, additional pending United States patent applications and counterpart patents and patent applications
in a number of jurisdictions, including Europe. Nevertheless, issued patents can be challenged, narrowed, invalidated or circumvented, which could limit our
ability to stop competitors from marketing similar products and threaten our ability to commercialize our product candidates. Our
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patent position, similar to other companies in our industry, is generally uncertain and involves complex legal and factual questions. To maintain our proprietary
position we will need to obtain effective claims and enforce these claims once granted. It is possible that, before any of our products can be commercialized, any
related patent may expire or remain in force only for a short period following commercialization, thereby reducing any advantage of the patent. Also, we do not
know whether any of our patent applications will result in any issued patents or, if issued, whether the scope of the issued claims will be sufficient to protect our
proprietary position.
We have entered into a License Agreement with Janssen Pharmaceutica (Janssen) pursuant to which we have licensed rights under certain patents owned by
Janssen covering an excipient used in the formulation of telavancin. We believe that the general and financial terms of the agreement with Janssen are ordinary
course terms. Pursuant to the terms of this license agreement, we are obligated to pay royalties and milestone payments to Janssen based on any commercial sales
of telavancin. The license is terminable by us upon prior written notice to Janssen or upon an uncured breach or a liquidation event of one of the parties.
Competition
Our objective is to discover, develop and commercialize new medicines with superior efficacy, convenience, tolerability and/or safety. We expect that any
medicines that we commercialize with our collaborative partners or on our own will compete with existing and future market-leading medicines.
Many of our potential competitors have substantially greater financial, technical and personnel resources than we have. In addition, many of these
competitors have significantly greater commercial infrastructures than we have. Our ability to compete successfully will depend largely on our ability to leverage
our experience in drug discovery and development to:
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discover and develop medicines that are superior to other products in the market;
attract qualified scientific, product development and commercial personnel;
obtain patent and/or other proprietary protection for our medicines and technologies;
obtain required regulatory approvals; and
successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines.
LABA Collaboration with GSK. We anticipate that, if approved, any product from our LABA collaboration with GSK, including RELOVAIR™ and the
LAMA/LABA '719/VI, will compete with a number of approved bronchodilator drugs and drug candidates under development that are designed to treat asthma
and COPD. These include but are not limited to Advair®/Seretide® (salmeterol and fluticasone as a combination) marketed by GSK, Foradil®/Oxis®
(formoterol) marketed by a number of companies, Symbicort® (formoterol and budesonide as a combination) marketed by AstraZeneca, Dulera® (formoterol and
mometasone as a combination) marketed by Merck, and Spiriva® (tiotropium) marketed by Boehringer-Ingelheim and Pfizer. Onbrez® (indacaterol) is marketed
in multiple international markets by Novartis and was approved as a single-agent by the FDA during 2011 with launch reportedly planned for early 2012. For
markets outside of the United States, Novartis is developing indacaterol in combination with an ICS (mometasone). In addition, indacaterol combined with a
muscarinic antagonist is being developed by Novartis. Boehringer-Ingelheim is developing a combination product with tiotropium and the long-acting beta
agonist olodaterol for the treatment of COPD. In addition, several firms are reported to be developing new formulations of salmeterol-fluticasone and formoterol-
budesonide which may be marketed as generics or branded generics relative to the existing products from GSK and AstraZeneca, respectively. All of these efforts
represent potential competition for any product from our LABA collaboration.
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VIBATIV® (telavancin). VIBATIV® competes with vancomycin, a generic drug that is manufactured by a variety of companies, as well as other drugs
marketed to treat complicated skin and skin structure infections caused by Gram-positive bacteria. Currently marketed products include but are not limited to
Cubicin® (daptomycin) marketed by Cubist Pharmaceuticals, Zyvox® (linezolid) and Tygacil® (tigecycline) both marketed by Pfizer, and Teflaro® (ceftaroline)
marketed by Forest Laboratories. To compete effectively with these medicines, and in particular with the relatively inexpensive generic option of vancomycin, we
will need to demonstrate to physicians that, based on experience, clinical data, side-effect profiles and other factors, VIBATIV® is preferable to vancomycin and
other existing or subsequently-developed anti-infective drugs in certain clinical situations.
In addition, as the principles of multivalent medicine design become more widely known and appreciated based on patent and scientific publications and
regulatory filings, we expect the field to become highly competitive. Pharmaceutical companies, biotechnology companies and academic and research institutions
may seek to develop product candidates based upon the principles underlying our multivalent technologies.
Employees
As of December 31, 2011, we had 222 employees, 171 of which were engaged primarily in research and development activities. None of our employees are
represented by a labor union. We consider our employee relations to be good.
Available Information
Our Internet address is www.theravance.com. Our investor relations website is located at http://ir.theravance.com. We make available free of charge on our
investor relations website under "SEC Filings" our Annual Reports on Form 10-K, Quarterly Reports on Form 10-Q, Current Reports on Form 8-K, our directors'
and officers' Section 16 Reports and any amendments to those reports as soon as reasonably practicable after filing or furnishing such materials to the U.S.
Securities and Exchange Commission (SEC). The information found on our website is not part of this or any other report that we file with or furnish to the SEC.
Theravance and the Theravance logo are registered trademarks of Theravance, Inc. Trademarks, tradenames or service marks of other companies appearing in this
report are the property of their respective owners.
ITEM 1A. RISK FACTORS
In addition to the other information in this Annual Report on Form 10-K, the following risk factors should be considered carefully in evaluating our business
and us.
Risks Related to our Business
If regulatory authorities determine that the RELOVAIR™ Phase 3 program in asthma or chronic obstructive pulmonary disease (COPD) does not
demonstrate safety and efficacy, the RELOVAIR™ program will be significantly delayed or terminated, our business will be harmed, and the price of our
securities could fall.
The RELOVAIR™ Phase 3 registrational program for COPD concluded in late 2011 and we currently expect the RELOVAIR™ Phase 3 registrational
program for asthma to conclude in the first half of 2012. The RELOVAIR™ Phase 3b program for COPD commenced in February 2011. In early 2012, we and
GSK reported topline results from the Phase 3 registrational program for COPD and all but one study from the Phase 3 registrational program for asthma. In
connection with reporting these topline results, GSK announced its intention (i) to submit in 2012 regulatory applications in the U.S. and Europe for COPD and
an application in Europe for asthma, and (ii) to continue discussions with the U.S. Food and Drug Administration (FDA) on the regulatory requirements for a U.S.
asthma indication. Any adverse developments or results or perceived adverse developments or results with
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respect to the RELOVAIR™ program will significantly harm our business and could cause the price of our securities to fall. Examples of such adverse
developments include, but are not limited to:
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not every study in the Phase 3 programs with RELOVAIR™ achieved its primary endpoint, and the FDA and/or other regulatory authorities may
determine that additional clinical studies are required;
inability to gain, or delay in gaining, regulatory approval for the new delivery device used in these programs;
safety or other concerns arising from non-clinical or clinical studies in these programs. For example, GSK is investigating reports of fatal
pneumonia with RELOVAIR™ primarily at the highest dose;
safety or other concerns arising from the ongoing long-acting muscarinic antagonist (LAMA)/long-acting beta2 agonist (LABA) Phase 3 program
having to do with the LABA vilanterol, or VI, which is also a component of RELOVAIR™;
regulatory authorities determining that the Phase 3 program in asthma or COPD raises safety concerns or does not demonstrate efficacy; or
any change in FDA policy or guidance regarding the use of LABAs to treat asthma.
On February 18, 2010, the FDA announced that LABAs should not be used alone in the treatment of asthma and will require manufacturers to include this
warning in the product labels of these drugs, along with taking other steps to reduce the overall use of these medicines. The FDA now requires that the product
labels for LABA medicines reflect, among other things, that the use of LABAs is contraindicated without the use of an asthma controller medication such as an
inhaled corticosteroid, that LABAs should only be used long-term in patients whose asthma cannot be adequately controlled on asthma controller medications,
and that LABAs should be used for the shortest duration of time required to achieve control of asthma symptoms and discontinued, if possible, once asthma
control is achieved. In addition, on March 10 and 11, 2010, the FDA held an Advisory Committee to discuss the design of medical research studies (known as
"clinical trial design") to evaluate serious asthma outcomes (such as hospitalizations, a procedure using a breathing tube known as intubation, or death) with the
use of LABAs in the treatment of asthma in adults, adolescents, and children. Further, in April 2011, the FDA announced that to further evaluate the safety of
LABAs, it is requiring the manufacturers of currently marketed LABAs to conduct additional randomized, double-blind, controlled clinical trials comparing the
addition of LABAs to inhaled corticosteroids versus inhaled corticosteroids alone. Results from these post-marketing studies are expected in 2017. It is unknown
at this time what, if any, effect these or future FDA actions will have on the development of RELOVAIR™. The current uncertainty regarding the FDA's position
on LABAs for the treatment of asthma and the lack of consensus expressed at the March 2010 Advisory Committee may result in increased time and cost of the
asthma clinical trials in the United States for RELOVAIR™ and increase the overall risk of the RELOVAIR™ asthma program in the United States.
If the '719/VI Phase 3 program for the treatment of COPD does not demonstrate safety and efficacy, the '719/VI program will be significantly delayed or
terminated, our business will be harmed, and the price of our securities could fall.
The '719/VI Phase 3 program with the combination of the LABA, VI, and the LAMA GSK573719, or '719, for the treatment of COPD commenced in
February 2011. Any adverse developments or results or perceived adverse developments or results with respect to the '719/VI program will significantly
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harm our business and could cause the price of our securities to fall. Examples of such adverse developments include, but are not limited to:
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the FDA and/or other regulatory authorities determining that additional clinical studies are required with respect to the Phase 3 program in COPD;
inability to gain, or delay in gaining, regulatory approval for the new delivery device used in the program;
safety or other concerns arising from ongoing non-clinical or clinical studies in this program;
safety or other concerns arising from the RELOVAIR™ Phase 3 programs having to do with the LABA, VI, which is also a component of '719/VI;
the Phase 3 program in COPD raising safety concerns or not demonstrating efficacy; or
any change in FDA policy or guidance regarding the use of LABAs combined with a LAMA to treat COPD.
If the MABA program for the treatment of COPD does not demonstrate safety and efficacy, the MABA program will be significantly delayed or terminated,
our business will be harmed, and the price of our securities could fall.
The lead compound, GSK961081 ('081), in the bifunctional muscarinic antagonist-beta2 agonist (MABA) program with GSK recently completed a Phase 2b
study and a Phase 1 study in combination with fluticasone propionate (FP), an inhaled corticosteroid (ICS), and a number of Phase 3-enabling non-clinical studies
are ongoing. We announced topline results from the Phase 2b COPD study in February 2012 and progression into Phase 3 is dependent upon successful
completion of the Phase 3-enabling studies. Any adverse developments or results or perceived adverse developments or results with respect to these studies will
harm our business and could cause the price of our securities to fall. Examples of such adverse developments include, but are not limited to:
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the FDA and/or other regulatory authorities determining that any of these studies do not demonstrate adequate safety or efficacy, or that additional
non-clinical or clinical studies are required with respect to the MABA program;
inability to gain, or delay in gaining, regulatory approval for the delivery device used in the program;
safety or other concerns arising from the Phase 3-enabling non-clinical studies; or
any change in FDA policy or guidance regarding the use of MABAs to treat COPD.
Our collaboration agreement for VIBATIV® was terminated in early 2012, VIBATIV® was returned to us, and we have no experience selling or distributing
products and no internal capability to do so.
Generally, our strategy is to engage pharmaceutical or other healthcare companies with an existing sales and marketing organization and distribution system
to market, sell and distribute our products. We may not be able to establish these sales and distribution relationships on acceptable terms, or at all. With
VIBATIV®, which was returned to us by Astellas in January 2012, and any of our product candidates that receive regulatory approval in the future and are not
covered by our current agreements with GSK or AstraZeneca, we will need a partner in order to commercialize such products unless we establish a sales and
marketing organization with appropriate technical expertise and supporting infrastructure and distribution capability. At present, we have no sales personnel and a
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limited number of marketing personnel. Factors that may inhibit our efforts to commercialize our products without strategic partners or licensees include:
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significant costs and expenses associated with creating an independent sales and marketing organization with appropriate technical expertise and
supporting infrastructure and distribution capability;
our unproven ability to recruit and retain adequate numbers of effective sales and marketing personnel;
the unproven ability of sales personnel to obtain access to or persuade adequate numbers of physicians to prescribe our products; and
the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with
more extensive product lines.
If we are not able to partner with a third party and are not successful in recruiting sales and marketing personnel or in building a sales and marketing
organization with appropriate technical expertise and supporting infrastructure and distribution capability, we will have difficulty commercializing VIBATIV®
and other product candidates, which would adversely affect our business and financial condition and which could cause the price of our securities to fall.
With regard to all of our programs, any delay in commencing or completing clinical studies for product candidates and any adverse results from clinical or
non-clinical studies or regulatory obstacles product candidates may face, would harm our business and could cause the price of our securities to fall.
Each of our product candidates must undergo extensive non-clinical and clinical studies as a condition to regulatory approval. Non-clinical and clinical
studies are expensive, take many years to complete and study results may lead to delays in further studies or decisions to terminate programs. For example, we
had planned to commence the Phase 2b study in our MABA program with GSK in 2009, but the program was delayed until late 2010.
The commencement and completion of clinical studies for our product candidates may be delayed and programs may be terminated due to many factors,
including, but not limited to:
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lack of effectiveness of product candidates during clinical studies;
adverse events, safety issues or side effects relating to the product candidates or their formulation into medicines;
inability to raise additional capital in sufficient amounts to continue our development programs, which are very expensive;
the need to sequence clinical studies as opposed to conducting them concomitantly in order to conserve resources;
our inability to enter into partnering arrangements relating to the development and commercialization of our programs and product candidates;
our inability or the inability of our collaborators or licensees to manufacture or obtain from third parties materials sufficient for use in non-clinical
and clinical studies;
governmental or regulatory delays and changes in regulatory requirements, policy and guidelines;
failure of our partners to advance our product candidates through clinical development;
delays in patient enrollment and variability in the number and types of patients available for clinical studies;
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difficulty in maintaining contact with patients after treatment, resulting in incomplete data;
varying regulatory requirements or interpretations of data among the FDA and foreign regulatory authorities; and
a regional disturbance where we or our collaborative partners are enrolling patients in clinical trials, such as a pandemic, terrorist activities or war,
political unrest or a natural disaster.
If our product candidates that we develop on our own or through collaborative partners are not approved by regulatory authorities, including the FDA, we
will be unable to commercialize them.
The FDA must approve any new medicine before it can be marketed and sold in the United States. We must provide the FDA and similar foreign regulatory
authorities with data from preclinical and clinical studies that demonstrate that our product candidates are safe and effective for a defined indication before they
can be approved for commercial distribution. We will not obtain this approval for a product candidate unless and until the FDA approves a NDA. The processes
by which regulatory approvals are obtained from the FDA to market and sell a new product are complex, require a number of years and involve the expenditure of
substantial resources. In order to market our medicines in foreign jurisdictions, we must obtain separate regulatory approvals in each country. The approval
procedure varies among countries and can involve additional testing, and the time required to obtain approval may differ from that required to obtain FDA
approval. Approval by the FDA does not ensure approval by regulatory authorities in other countries, and approval by one foreign regulatory authority does not
ensure approval by regulatory authorities in other foreign countries or by the FDA. Conversely, failure to obtain approval in one or more jurisdictions may make
approval in other jurisdictions more difficult.
Clinical studies involving our product candidates may reveal that those candidates are ineffective, inferior to existing approved medicines, unacceptably
toxic, or that they have other unacceptable side effects. In addition, the results of preclinical studies do not necessarily predict clinical success, and larger and
later-stage clinical studies may not produce the same results as earlier-stage clinical studies.
Frequently, product candidates that have shown promising results in early preclinical or clinical studies have subsequently suffered significant setbacks or
failed in later clinical studies. In addition, clinical studies of potential products often reveal that it is not possible or practical to continue development efforts for
these product candidates. If our clinical studies are substantially delayed or fail to prove the safety and effectiveness of our product candidates in development, we
may not receive regulatory approval of any of these product candidates and our business and financial condition will be materially harmed and the price of our
securities may fall.
If telavancin is not approved for nosocomial pneumonia (NP) in the United States, the commercialization of VIBATIV® in the U.S. will continue to be
adversely affected and the price of our securities could fall.
Our first New Drug Application (NDA), for VIBATIV® (telavancin) for the treatment of complicated skin and skin structure infections (cSSSI) caused by
susceptible Gram-positive bacteria in adult patients, was approved by the FDA in September 2009. In January 2009, we submitted a second telavancin NDA to
the FDA for the NP indication based on data from our two Phase 3 studies referred to as the ATTAIN studies. These studies were conducted in accordance with
the then current draft FDA guidelines and met their primary efficacy endpoint of clinical cure. During the fourth quarter of 2010 the FDA issued new draft
guidance for antibacterial clinical trial design for the treatment of NP with a focus on mortality as the primary efficacy endpoint. In late 2010, we received a
Complete Response Letter from the FDA indicating that the ATTAIN studies do not meet the new draft guidance and that additional clinical studies will be
required for approval. We do not plan to conduct additional clinical studies for NP, but we do intend to continue to engage with FDA concerning the NP
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NDA. Lack of FDA approval for use of telavancin to treat NP has adversely affected and may continue to adversely affect commercialization of this medicine in
the United States.
If any product candidates, in particular those in any respiratory program with GSK, are determined to be unsafe or ineffective in humans, our business will
be adversely affected and the price of our securities could fall.
Although our first product, VIBATIV®, is approved in the U.S. and Canada, none of our other product candidates have been approved by regulatory
authorities. We are uncertain whether any of our other product candidates will prove effective and safe in humans or meet applicable regulatory standards. In
addition, our approach to applying our expertise in multivalency to drug discovery may not result in the creation of successful medicines. The risk of failure for
our product candidates is high. For example, in late 2005, we discontinued our overactive bladder program based upon the results of our Phase 1 studies with
compound TD-6301, and GSK discontinued development of TD-5742, the first LAMA compound licensed from us, after completing a single-dose Phase 1 study.
The data supporting our drug discovery and development programs is derived solely from laboratory experiments, non-clinical studies and clinical studies. A
number of other compounds remain in the lead identification, lead optimization, preclinical testing or early clinical testing stages.
Several well-publicized Complete Response letters issued by the FDA and safety-related product withdrawals, suspensions, post-approval labeling revisions
to include boxed warnings and changes in approved indications over the last several years, as well as growing public and governmental scrutiny of safety issues,
have created an increasingly conservative regulatory environment. The implementation of new laws and regulations, and revisions to FDA clinical trial design
guidance, have increased uncertainty regarding the approvability of a new drug. Further, there are additional requirements for approval of new drugs, including
advisory committee meetings for new chemical entities, and formal risk evaluation and mitigation strategy (REMS) at the FDA's discretion. These new laws,
regulations, additional requirements and changes in interpretation could cause non-approval or further delays in the FDA's review and approval of our product
candidates.
There is currently a single manufacturer for VIBATIV® product supply and we rely on a single source of supply for a number of our product candidates;
accordingly, our business will be harmed if these manufacturers are not able to satisfy demand and alternative sources are not available.
There is currently a single source of supply of telavancin API and a single source of supply of VIBATIV® drug product. If, for any reason, these third parties
are unable or unwilling to perform, or if their performance does not meet regulatory requirements, including maintaining current good manufacturing practice
(cGMP) compliance, we may not be able to locate alternative manufacturers, enter into acceptable agreements with them or obtain sufficient quantities of API and
drug product in a timely manner. Any inability to acquire sufficient quantities of API and drug product in a timely manner from current or future sources could
further adversely affect the commercialization of VIBATIV® and could cause the price of our securities to fall.
During the fourth quarter of 2011, the third party manufacturer of VIBATIV® drug product notified the FDA of an ongoing investigation related to its
production equipment and processes. The notification included all products manufactured at the third party manufacturer's facility which remain within expiry,
including batches of manufactured but unreleased VIBATIV®. In November 2011, Astellas (our former VIBATIV® collaboration partner) voluntarily placed a
hold on distribution of VIBATIV® to wholesalers, and cancelled pending orders for VIBATIV® with this manufacturer. VIBATIV® drug product previously
manufactured by, and still on-site at, this manufacturer will not become available for sale in the U.S. unless and until the batches are released. We cannot predict
when or if the manufactured batches of VIBATIV® will be released. In addition, in August 2011 the third party manufacturer of VIBATIV® drug product
announced its intention to transition out of the
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contract manufacturing services business over the next several years. Additional VIBATIV® drug product will need to be manufactured to meet longer-term U.S.
demand as well as demand from the E.U. and Canada. In February 2012 the Committee for Medicinal Products for Human Use (CHMP) recommended to the
European Commission that it suspend marketing authorization for VIBATIV® because the single-source VIBATIV® drug product supplier does not meet the
GMP requirements to allow the manufacture of VIBATIV®. No VIBATIV® drug product intended to meet E.U. specifications has as yet been manufactured.
Identifying and qualifying an alternative manufacturer for VIBATIV® drug product may take 12 to 24 months.
If the VIBATIV® drug product on-site at the third party manufacturer is not released in the near future, the commercialization of VIBATIV® in the U.S. will
continue to be adversely affected, and if supplemental or alternative commercial manufacture of VIBATIV® drug product cannot be arranged on a timely basis,
the commercial introduction of VIBATIV® in the E.U. and Canada will be materially delayed. In each such case, our business will be harmed and the price of our
securities could fall.
With respect to our programs other than VIBATIV®, we have limited in-house production capabilities for non-clinical and early clinical study purposes, and
depend primarily on a number of third-party API and drug product manufacturers. We may not have long-term agreements with these third parties and our
agreements with these parties may be terminable at will by either party at any time. If, for any reason, these third parties are unable or unwilling to perform, or if
their performance does not meet regulatory requirements, we may not be able to locate alternative manufacturers or enter into acceptable agreements with them.
Any inability to acquire sufficient quantities of API and drug product in a timely manner from these third parties could delay clinical studies, prevent us from
developing our product candidates in a cost-effective manner or on a timely basis. In addition, manufacturers of our API and drug product are subject to the
FDA's cGMP regulations and similar foreign standards and we do not have control over compliance with these regulations by our manufacturers.
Our manufacturing strategy presents the following additional risks:
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•
•
because of the complex nature of our compounds, our manufacturers may not be able to successfully manufacture our APIs and/or drug products
in a cost effective and/or timely manner and changing manufacturers for our APIs or drug products could involve lengthy technology transfer and
validation activities for the new manufacturer;
the processes required to manufacture certain of our APIs and drug products are specialized and available only from a limited number of third-
party manufacturers;
some of the manufacturing processes for our APIs and drug products have not been scaled to quantities needed for continued clinical studies or
commercial sales, and delays in scale-up to commercial quantities could delay clinical studies, regulatory submissions and commercialization of
our product candidates; and
because some of the third-party manufacturers are located outside of the U.S., there may be difficulties in importing our APIs and drug products or
their components into the U.S. as a result of, among other things, FDA import inspections, incomplete or inaccurate import documentation or
defective packaging.
Even if our product candidates receive regulatory approval, as VIBATIV® has, commercialization of such products may be adversely affected by regulatory
actions and oversight.
Even if we receive regulatory approval for our product candidates, this approval may include limitations on the indicated uses for which we can market our
medicines or the patient population that may utilize our medicines, which may limit the market for our medicines or put us at a competitive disadvantage relative
to alternative therapies. For example, VIBATIV®'s U.S. labeling contains a boxed
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warning regarding the risks of use of VIBATIV® during pregnancy. Products with boxed warnings are subject to more restrictive advertising regulations than
products without such warnings. In addition, the VIBATIV® labeling that was approved for the E.U. in 2011 specifies that VIBATIV® should be used only in
situations where it is known or suspected that other alternatives are not suitable. These restrictions could make it more difficult to market VIBATIV®. Further, in
February 2012 the CHMP recommended to the European Commission that it suspend marketing authorization for VIBATIV® because the single-source
VIBATIV® drug product supplier does not meet the GMP requirements to allow the manufacture of VIBATIV®. With VIBATIV® approved in certain countries,
we are subject to continuing regulatory obligations, such as safety reporting requirements and additional post-marketing obligations, including regulatory
oversight of promotion and marketing.
In addition, the manufacturing, labeling, packaging, adverse event reporting, advertising, promotion and recordkeeping for the approved product remain
subject to extensive and ongoing regulatory requirements. If we become aware of previously unknown problems with an approved product in the U.S. or overseas
or at contract manufacturers' facilities, a regulatory authority may impose restrictions on the product, the contract manufacturers or on us, including requiring us
to reformulate the product, conduct additional clinical studies, change the labeling of the product, withdraw the product from the market or require the contract
manufacturer to implement changes to its facilities. For example, during the fourth quarter of 2011, the third party manufacturer of VIBATIV® drug product
notified the FDA of an ongoing investigation related to its production equipment and processes. The notification included all products manufactured at the third
party manufacturer's facility which remain within expiry, including batches of manufactured but unreleased VIBATIV®. Astellas (our former VIBATIV®
collaboration partner) subsequently placed a voluntary hold on distribution of VIBATIV® to wholesalers and cancelled pending orders for VIBATIV® with this
manufacturer. With this supply interruption and the termination of our VIBATIV® collaboration agreement with Astellas, commercialization of VIBATIV® has
essentially stopped, we will likely experience a significant drop in the sales of the product and the reputation of VIBATIV® in the marketplace may suffer.
We are also subject to regulation by regional, national, state and local agencies, including the Department of Justice, the Federal Trade Commission, the
Office of Inspector General of the U.S. Department of Health and Human Services and other regulatory bodies with respect to VIBATIV®, as well as
governmental authorities in those foreign countries in which any of our product candidates are approved for commercialization. The Federal Food, Drug, and
Cosmetic Act, the Public Health Service Act and other federal and state statutes and regulations govern to varying degrees the research, development,
manufacturing and commercial activities relating to prescription pharmaceutical products, including non-clinical and clinical testing, approval, production,
labeling, sale, distribution, import, export, post-market surveillance, advertising, dissemination of information and promotion. If we or any third parties that
provide these services for us are unable to comply, we may be subject to regulatory or civil actions or penalties that could significantly and adversely affect our
business. Any failure to maintain regulatory approval will limit our ability to commercialize our product candidates, which would materially and adversely affect
our business and financial condition, which may cause our stock price to decline.
We have incurred operating losses in each year since our inception and expect to continue to incur substantial losses for the foreseeable future.
We have been engaged in discovering and developing compounds and product candidates since mid-1997. Our first approved product, VIBATIV®, was
launched by our partner Astellas in the U.S. in November 2009, and to date we have received only modest revenues from VIBATIV® sales. We may never
generate sufficient revenue from the sale of medicines or royalties on sales by our partners to achieve profitability. As of December 31, 2011, we had an
accumulated deficit of approximately $1.3 billion.
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We expect to incur substantial expenses as we continue our drug discovery and development efforts, particularly to the extent we advance our product
candidates into and through clinical studies, which are very expensive. As a result, we expect to continue to incur substantial losses for the foreseeable future. We
are uncertain when or if we will be able to achieve or sustain profitability. Failure to become and remain profitable would adversely affect the price of our
securities and our ability to raise capital and continue operations.
If we fail to obtain the capital necessary to fund our operations, we may be unable to develop our product candidates or commercialize VIBATIV® and we
could be forced to share our rights to commercialize our product candidates with third parties on terms that may not be favorable to us.
We need large amounts of capital to support our research and development efforts. If we are unable to secure capital to fund our operations we will not be
able to continue our discovery and development efforts and we might have to enter into strategic collaborations that could require us to share commercial rights to
our medicines to a greater extent than we currently intend. Based on our current operating plans, milestone and royalty forecasts and spending assumptions, we
believe that our cash and cash equivalents and marketable securities will be sufficient to meet our anticipated operating needs for at least the next twelve months.
We are likely to require additional capital to fund operating needs thereafter. Although we have no current intention to do so, if we were to conduct additional
studies to support the telavancin NP NDA, or if we were to build the sales and marketing, distribution and compliance infrastructure to commercialize
VIBATIV® without a partner, our capital needs would increase substantially. We intend to continue development of our pipeline. A Phase 2b program is
underway in our PµMA program and we initiated a Phase 2 study for MARIN in late 2011. We also intend to invest in other assets in our pipeline, including our
Hepatitis C virus (HCV) and cardiovascular programs in late-stage discovery, and conduct a number of other non-clinical and earlier-stage clinical studies in other
programs. Further, pursuant to the terms of the recent termination of our collaboration agreement with Astellas, we may purchase up to $11.0 million of
VIBATIV® inventory during 2012. In addition, under our LABA collaboration with GSK, in the event that vilanterol (VI), which is the current lead LABA
product candidate in RELOVAIR™ and LAMA/LABA ('719/VI) and which was discovered by GSK, is approved and launched in multiple regions of the world
as both a single agent and a combination product or two different combination products, we will be obligated to pay GSK milestone payments that could total as
much as $220.0 million and we would not be entitled to receive any further milestone payments from GSK. Future financing to meet our capital needs may not be
available in sufficient amounts or on terms acceptable to us, if at all. Even if we are able to raise additional capital, such financing may result in significant
dilution to existing security holders. If we are unable to raise additional capital in sufficient amounts or on terms acceptable to us, we may have to make
reductions in our workforce and may be prevented from continuing our discovery and development efforts and exploiting other corporate opportunities. This
could harm our business, prospects and financial condition and cause the price of our securities to fall.
VIBATIV® may not be accepted by physicians, patients, third party payors, or the medical community in general, and this risk is aggravated by the current
critical product shortages and regional supply outages.
The commercial success of VIBATIV® depends upon its acceptance by physicians, patients, third party payors and the medical community in general. We
cannot be sure that VIBATIV® will be accepted by these parties. VIBATIV® competes with vancomycin, a relatively inexpensive generic drug that is
manufactured by a variety of companies, and a number of existing antibacterials manufactured and marketed by major pharmaceutical companies and others, and
may compete against new antibacterials that are not yet on the market. Even if the medical community accepts that VIBATIV® is safe and efficacious for its
indicated use, physicians may restrict the use of VIBATIV® due to the current product shortages stemming from the manufacturing issues at the drug product
supplier, the recent termination of our VIBATIV® collaboration agreement with Astellas, or otherwise. If we are
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unable to demonstrate to physicians that, based on experience, clinical data, side-effect profiles and other factors, VIBATIV® is preferable to vancomycin and
other antibacterial drugs, we may never generate meaningful revenue from VIBATIV® which could cause the price of our securities to fall. The degree of market
acceptance of VIBATIV® depends on a number of factors, including, but not limited to:
•
•
•
•
•
•
•
•
the demonstration of the clinical efficacy and safety of VIBATIV®;
the experiences of physicians, patients and payors with the use of VIBATIV® in the U.S.;
potential negative perceptions of physicians related to our inability to obtain FDA approval of our NP NDA, the product shortages stemming from
the manufacturing issues at the drug product supplier or the recent termination of our VIBATIV® collaboration agreement with Astellas;
potential negative perceptions of physicians related to the recent CHMP recommendation to the European Commission that it suspend marketing
authorization for VIBATIV® because the single-source VIBATIV® drug product supplier does not meet the GMP requirements to allow the
manufacture of VIBATIV®;
the advantages and disadvantages of VIBATIV® compared to alternative therapies;
our ability to educate the medical community about the safety and effectiveness of VIBATIV®;
the reimbursement policies of government and third party payors; and
the market price of VIBATIV® relative to competing therapies.
If our partners do not satisfy their obligations under our agreements with them, or if they terminate our partnerships with them, as Astellas did with our
VIBATIV® collaboration agreement in January 2012, we may not be able to develop or commercialize our partnered product candidates as planned.
We entered into our LABA collaboration agreement with GSK in November 2002, our strategic alliance agreement with GSK in March 2004, and our
VIBATIV® collaboration agreement with Astellas in November 2005. In connection with these agreements, we have granted to these parties certain rights
regarding the use of our patents and technology with respect to compounds in our development programs, including development and marketing rights. Under our
GSK agreements, GSK has full responsibility for development and commercialization of RELOVAIR™, LAMA/LABA ('719/VI) and any product candidates in
the MABA program. Any future milestone payments or royalties to us from these programs will depend on the extent to which GSK advances the product
candidate through development and, if approved, commercialization. Astellas terminated the VIBATIV® agreement in January 2012.
Our partners might not fulfill all of their obligations under these agreements, and, in certain circumstances, they may terminate our partnership with them, as
Astellas did in January 2012. In either event, we may be unable to assume the development and commercialization of the product candidates covered by the
agreements or enter into alternative arrangements with a third party to develop and commercialize such product candidates. In addition, with the exception of
product candidates in our LABA collaboration and the MABA program under the strategic alliance, our partners generally are not restricted from developing and
commercializing their own products and product candidates that compete with those licensed from us. If a partner elected to promote its own products and
product candidates in preference to those licensed from us, future payments to us could be reduced and our business and financial condition would be materially
and adversely affected. Accordingly, our ability to receive any revenue from the product candidates covered by these agreements is dependent on the efforts of the
partner. We could also become involved in disputes with a partner, which could lead to
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delays in or termination of our development and commercialization programs and time-consuming and expensive litigation or arbitration.
If a partner terminates or breaches its agreements with us, or otherwise fails to complete its obligations in a timely manner, the chances of successfully
developing or commercializing product candidates under the collaboration could be materially and adversely affected. For example, Astellas terminated the
VIBATIV® collaboration agreement in January 2012, and both due to the termination and the current product shortages and regional supply outages stemming
from the manufacturing issues at the third party VIBATIV® drug product supplier, the commercialization of VIBATIV® in the U.S. has essentially stopped and
the commercial introduction of VIBATIV® in the E.U. and Canada has been delayed.
If we are unable to enter into future collaboration arrangements or if any such collaborations with third parties are unsuccessful, we will be unable to fully
develop and commercialize VIBATIV® and our product candidates and our business will be adversely affected.
We have active collaborations with GSK for RELOVAIR™, LAMA/LABA ('719/VI) and the MABA program and we have licensed our anesthesia
compound to AstraZeneca AB (AstraZeneca). Additional collaborations will be needed to fund later-stage development of our product candidates that have not
been licensed to a collaborator, and to commercialize these product candidates if approved by the necessary regulatory authorities. Each of TD-5108, our lead
compound in the 5-HT4 program, TD-1792, our investigational antibiotic, TD-1211, the lead compound in our PµMA program for opioid-induced constipation
and TD-4208, our LAMA compound, has successfully completed a Phase 2 proof-of-concept study. In addition, in connection with the expansion of the MABA
program under the strategic alliance with GSK in October 2011, GSK relinquished its right to option our MARIN and ARNI programs. Also, we now have full
rights to VIBATIV® as a result of the termination of our collaboration agreement with Astellas in January 2012. We currently intend to seek third parties with
which to pursue collaboration arrangements for the development and commercialization of our development programs and for the future commercialization of
VIBATIV®. Collaborations with third parties regarding these programs or our other programs may require us to relinquish material rights, including revenue
from commercialization of our medicines, on terms that are less attractive than our current arrangements or to assume material ongoing development obligations
that we would have to fund. These collaboration arrangements are complex and time-consuming to negotiate, and if we are unable to reach agreements with third-
party collaborators, we may fail to meet our business objectives and our financial condition may be adversely affected. We face significant competition in seeking
third-party collaborators, especially in the current uncertain economy, which is driving many biotechnology and biopharmaceutical companies to seek to sell or
license their assets. We may be unable to find third parties to pursue product collaborations on a timely basis or on acceptable terms. Furthermore, for any
collaboration, we may not be able to control the amount of time and resources that our partners devote to our product candidates and our partners may choose to
pursue alternative products. Our inability to successfully collaborate with third parties would increase our development costs and would limit the likelihood of
successful commercialization of our product candidates which may cause our stock price to decline.
We depend on third parties in the conduct of our clinical studies for our product candidates.
We depend on independent clinical investigators, contract research organizations and other third-party service providers in the conduct of our non-clinical
and clinical studies for our product candidates. We rely heavily on these parties for execution of our non-clinical and clinical studies, and control only certain
aspects of their activities. Nevertheless, we are responsible for ensuring that our clinical studies are conducted in accordance with good clinical practices (GCPs)
and other regulations as required by the FDA and foreign regulatory authorities, and the applicable protocol. Failure by these
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parties to comply with applicable regulations, GCPs and protocols in conducting studies of our product candidates can result in a delay in our development
programs or non-approval of our product candidates by regulatory authorities.
The FDA enforces good clinical practices and other regulations through periodic inspections of trial sponsors, clinical research organizations (CROs),
principal investigators and trial sites. For example, in connection with the FDA's review of our telavancin NDAs, the FDA conducted inspections of Theravance
and certain of our study sites, clinical investigators and CROs. If we or any of the third parties on which we have relied to conduct our clinical studies are
determined to have failed to comply with GCPs, the study protocol or applicable regulations, the clinical data generated in our studies may be deemed unreliable.
This could result in non-approval of our product candidates by the FDA, or we or the FDA may decide to conduct additional audits or require additional clinical
studies, which would delay our development programs, could result in significant additional costs and could cause the price of our securities to fall.
We face substantial competition from companies with more resources and experience than we have, which may result in others discovering, developing,
receiving approval for or commercializing products before or more successfully than we do.
Our ability to succeed in the future depends on our ability to demonstrate and maintain a competitive advantage with respect to our approach to the discovery
and development of medicines. Our objective is to discover, develop and commercialize new small molecule medicines with superior efficacy, convenience,
tolerability and/or safety. We expect that any medicines that we commercialize with our collaborative partners will compete with existing or future market-leading
medicines.
Many of our potential competitors have substantially greater financial, technical and personnel resources than we have. In addition, many of these
competitors have significantly greater commercial infrastructures than we have. Our ability to compete successfully will depend largely on our ability to leverage
our experience in drug discovery and development to:
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discover and develop medicines that are superior to other products in the market;
attract and retain qualified personnel;
obtain patent and/or other proprietary protection for our medicines and technologies;
obtain required regulatory approvals; and
successfully collaborate with pharmaceutical companies in the discovery, development and commercialization of new medicines.
Established pharmaceutical companies may invest heavily to quickly discover and develop or in-license novel compounds that could make our product
candidates obsolete. Accordingly, our competitors may succeed in obtaining patent protection, receiving FDA approval or discovering, developing and
commercializing medicines before we do. Other companies are engaged in the discovery of medicines that would compete with the product candidates that we are
developing.
Any new medicine that competes with a generic or proprietary market leading medicine must demonstrate compelling advantages in efficacy, convenience,
tolerability and/or safety in order to overcome severe price competition and be commercially successful. VIBATIV® must demonstrate these advantages, as it
competes with vancomycin, a relatively inexpensive generic drug that is manufactured by a number of companies, and a number of existing antibacterial drugs
marketed by major and other pharmaceutical companies. If we are not able to compete effectively against our current and future competitors, our business will not
grow, our financial condition and operations will suffer and the price of our securities could fall.
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As the principles of multivalency become more widely known, we expect to face increasing competition from companies and other organizations that pursue
the same or similar approaches. Novel therapies, such as gene therapy or effective vaccines for infectious diseases, may emerge that will make both conventional
and multivalent medicine discovery efforts obsolete or less competitive.
If we lose key management or scientific personnel, or if we fail to retain our key employees, our ability to discover and develop our product candidates will be
impaired.
We are highly dependent on principal members of our management team and scientific staff to operate our business. Our company is located in northern
California, which is headquarters to many other biotechnology and biopharmaceutical companies and many academic and research institutions. As a result,
competition for certain skilled personnel in our market remains intense. None of our employees have employment commitments for any fixed period of time and
they all may leave our employment at will. If we fail to retain our qualified personnel or replace them when they leave, we may be unable to continue our
development and commercialization activities, which may cause our stock price to decline.
Our business and operations would suffer in the event of system failures.
Although we have security measures in place, our internal computer systems and those of our CROs and other service providers are vulnerable to damage
from computer viruses, unauthorized access, natural disasters, terrorism, war and telecommunication and electrical failures. We have not experienced any material
system failure, accident or security breach to date, but if such an event were to occur, it could result in a material disruption to our business. For example, the loss
of clinical trial data from completed or ongoing clinical trials of our product candidates could result in delays in our regulatory approval efforts and significantly
increase our costs to recover or reproduce the data. If a disruption or security breach results in a loss of or damage to our data or regulatory applications, or
inadvertent disclosure of confidential or proprietary information, we could incur liability, the further development of our product candidates could be delayed and
the price of our securities could fall.
Our principal facility is located near known earthquake fault zones, and the occurrence of an earthquake, extremist attack or other catastrophic disaster
could cause damage to our facilities and equipment, which could require us to cease or curtail operations.
Our principal facility is located in the San Francisco Bay Area near known earthquake fault zones and therefore is vulnerable to damage from earthquakes.
In October 1989, a major earthquake struck this area and caused significant property damage and a number of fatalities. We are also vulnerable to damage from
other types of disasters, including power loss, attacks from extremist organizations, fire, floods, communications failures and similar events. If any disaster were
to occur, our ability to operate our business could be seriously impaired. In addition, the unique nature of our research activities and of much of our equipment
could make it difficult for us to recover from this type of disaster. We may not have adequate insurance to cover our losses resulting from disasters or other
similar significant business interruptions and we do not plan to purchase additional insurance to cover such losses due to the cost of obtaining such coverage. Any
significant losses that are not recoverable under our insurance policies could seriously impair our business and financial condition, which could cause the price of
our securities to fall.
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Risks Related to our Alliance with GSK
GSK's ownership of a significant percentage of our stock and its ability to acquire additional shares of our stock may create conflicts of interest, and may
inhibit our management's ability to continue to operate our business in the manner in which it is currently being operated.
As of February 17, 2012, GSK beneficially owned approximately 18.4% of our outstanding capital stock, and GSK has the right to acquire stock from us to
maintain its percentage ownership of our capital stock. GSK could have substantial influence in the election of our directors, delay or prevent a transaction in
which stockholders might receive a premium over the prevailing market price for their shares and have significant control over certain changes in our business.
In addition, GSK may make an offer to our stockholders to acquire outstanding voting stock that would bring GSK's percentage ownership of our voting
stock to no greater than 60%, provided that:
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•
the offer includes no condition as to financing;
the offer is approved by a majority of our independent directors;
the offer includes a condition that the holders of a majority of the shares of the voting stock not owned by GSK accept the offer by tendering their
shares in the offer; and
the shares purchased will be subject to the same provisions of the governance agreement as are the shares of voting stock currently held by GSK.
If pursuant to the provision described above GSK's ownership of us becomes greater than 50.1%, then on or prior to September 1, 2012 GSK is allowed to
make an offer to our stockholders to merge with us or otherwise acquire outstanding voting stock that would bring GSK's percentage ownership of our voting
stock to 100%, provided that;
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•
the offer includes no condition as to financing;
the offer is approved by a majority of our independent directors;
the offer includes a condition that the holders of a majority of the shares of the voting stock not owned by GSK accept the offer by tendering their
shares in the offer; and
the offer is for the greater of (a) the fair market value per share on the date immediately preceding the date of the first public announcement of the
offer or (b) $162.75 per share (as adjusted to take into account stock dividends, stock splits, recapitalizations and the like).
Furthermore, if pursuant to the provision described above GSK's ownership of us is greater than 50.1%, then after September 1, 2012, GSK is allowed to
make an offer to our stockholders to acquire outstanding voting stock that would bring GSK's percentage ownership of our voting stock to 100%, provided that;
•
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•
the offer includes no condition as to financing;
the offer is approved by a majority of our independent directors; and
the offer includes a condition that the holders of a majority of the shares of the voting stock not owned by GSK accept the offer by tendering their
shares in the offer.
Further, pursuant to our certificate of incorporation, we renounce our interest in and waive any claim that a corporate or business opportunity taken by GSK
constitutes a corporate opportunity of ours unless such corporate or business opportunity is expressly offered to one of our directors who is a director, officer or
employee of GSK, primarily in his or her capacity as one of our directors.
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GSK's rights under the governance agreement may deter or prevent efforts by other companies to acquire us, which could prevent our stockholders from
realizing a control premium.
Our governance agreement with GSK requires us to exempt GSK from our stockholder rights plan, affords GSK certain rights to offer to acquire us in the
event third parties seek to acquire our stock and contains other provisions that could deter or prevent another company from seeking to acquire us. For example,
GSK may offer to acquire 100% of our outstanding stock from stockholders in certain circumstances, such as if we are faced with a hostile acquisition offer or if
our board of directors acts in a manner to facilitate a change in control of us with a party other than GSK. As a result of these rights, other companies may be less
inclined to pursue an acquisition of us and therefore we may not have the opportunity to be acquired in a transaction that stockholders might otherwise deem
favorable, including transactions in which our stockholders might realize a substantial premium for their shares.
GSK could sell or transfer a substantial number of shares of our common stock, which could depress the price of our securities or result in a change in
control of our company.
Under our governance agreement with GSK, GSK currently may sell or transfer our common stock only pursuant to a public offering registered under the
Securities Act or pursuant to Rule 144 of the Securities Act. Beginning in September 2012, GSK will have no contractual restrictions on its ability to sell or
transfer our common stock on the open market, in privately negotiated transactions or otherwise, and these sales or transfers could create substantial declines in
the price of our securities or, if these sales or transfers were made to a single buyer or group of buyers, could contribute to a transfer of control of our company to
a third party.
Risks Related to Legal and Regulatory Uncertainty
If our efforts to protect the proprietary nature of the intellectual property related to our technologies are not adequate, we may not be able to compete
effectively in our market.
We rely upon a combination of patents, patent applications, trade secret protection and confidentiality agreements to protect the intellectual property related
to our technologies. Any involuntary disclosure to or misappropriation by third parties of this proprietary information could enable competitors to quickly
duplicate or surpass our technological achievements, thus eroding our competitive position in our market. The status of patents in the biotechnology and
pharmaceutical field involves complex legal and scientific questions and is very uncertain. As of December 31, 2011, we owned 271 issued United States patents
and 907 granted foreign patents, as well as additional pending United States and foreign patent applications. Our patent applications may be challenged or fail to
result in issued patents and our existing or future patents may be invalidated or be too narrow to prevent third parties from developing or designing around these
patents. If the sufficiency of the breadth or strength of protection provided by our patents with respect to a product candidate is threatened, it could dissuade
companies from collaborating with us to develop, and threaten our ability to commercialize, the product candidate. Further, if we encounter delays in our clinical
trials or in obtaining regulatory approval of our product candidates, the patent lives of the related product candidates would be reduced.
In addition, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable, for processes for which
patents are difficult to enforce and for any other elements of our drug discovery and development processes that involve proprietary know-how, information and
technology that is not covered by patent applications. Although we require our employees, consultants, advisors and any third parties who have access to our
proprietary know-how, information and technology to enter into confidentiality agreements, we cannot be certain that this know-how, information and technology
will not be disclosed or that competitors will not otherwise gain access to our trade secrets or independently develop substantially equivalent information
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and techniques. Further, the laws of some foreign countries do not protect proprietary rights to the same extent as the laws of the United States. As a result, we
may encounter significant problems in protecting and defending our intellectual property both in the United States and abroad. If we are unable to prevent
material disclosure of the intellectual property related to our technologies to third parties, we will not be able to establish or, if established, maintain a competitive
advantage in our market, which could materially adversely affect our business, financial condition and results of operations, which could cause the price of our
securities to fall.
Litigation or third-party claims of intellectual property infringement would require us to divert resources and may prevent or delay our drug discovery and
development efforts.
Our commercial success depends in part on us and our partners not infringing the patents and proprietary rights of third parties. Third parties may assert that
we or our partners are using their proprietary rights without authorization. There are third party patents that may cover materials or methods for treatment related
to our product candidates. At present, we are not aware of any patent claims with merit that would adversely and materially affect our ability to develop our
product candidates, but nevertheless the possibility of third party allegations cannot be ruled out. In addition, third parties may obtain patents in the future and
claim that use of our technologies infringes upon these patents. Furthermore, parties making claims against us or our partners may obtain injunctive or other
equitable relief, which could effectively block our ability to further develop and commercialize one or more of our product candidates. Defense of these claims,
regardless of their merit, would involve substantial litigation expense and would be a substantial diversion of employee resources from our business.
In the event of a successful claim of infringement against us, we may have to pay substantial damages, obtain one or more licenses from third parties or pay
royalties. In addition, even in the absence of litigation, we may need to obtain licenses from third parties to advance our research or allow commercialization of
our product candidates, and we have done so from time to time. We may fail to obtain any of these licenses at a reasonable cost or on reasonable terms, if at all. In
that event, we would be unable to further develop and commercialize one or more of our product candidates, which could harm our business significantly. In
addition, in the future we could be required to initiate litigation to enforce our proprietary rights against infringement by third parties. Prosecution of these claims
to enforce our rights against others would involve substantial litigation expenses and divert substantial employee resources from our business. If we fail to
effectively enforce our proprietary rights against others, our business will be harmed, which may cause our stock price to decline.
If the efforts of our partner, GSK, to protect the proprietary nature of the intellectual property related to the assets in the LABA collaboration, including
RELOVAIR™ and LAMA/LABA ('719/VI), are not adequate, the future commercialization of any medicines resulting from the LABA collaboration could be
delayed or prevented, which would materially harm our business and could cause the price of our securities to fall.
The risks identified in the two preceding risk factors also apply to the intellectual property protection efforts of our partner, GSK. To the extent the
intellectual property protection of any of the assets in the LABA collaboration are successfully challenged or encounter problems with the United States Patent
and Trademark Office or other comparable agencies throughout the world, the future commercialization of these potential medicines could be delayed or
prevented. Any challenge to the intellectual property protection of a late-stage development asset arising from the LABA collaboration could harm our business
and cause the price of our securities to fall.
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Product liability lawsuits could divert our resources, result in substantial liabilities and reduce the commercial potential of our medicines.
The risk that we may be sued on product liability claims is inherent in the development and commercialization of pharmaceutical products. Side effects of, or
manufacturing defects in, products that we or our partners develop or commercialize could result in the deterioration of a patient's condition, injury or even death.
Once a product is approved for sale and commercialized, the likelihood of product liability lawsuits tends to increase. Claims may be brought by individuals
seeking relief for themselves or by individuals or groups seeking to represent a class. These lawsuits may divert our management from pursuing our business
strategy and may be costly to defend. In addition, if we are held liable in any of these lawsuits, we may incur substantial liabilities and may be forced to limit or
forgo further commercialization of the applicable products.
Although we maintain general liability and product liability insurance, this insurance may not fully cover potential liabilities. In addition, inability to obtain
or maintain sufficient insurance coverage at an acceptable cost or to otherwise protect against potential product liability claims could prevent or inhibit the
commercial production and sale of our products, which could adversely affect our business. Product liability claims could also harm our reputation, which may
adversely affect our and our partners' ability to commercialize our products successfully, which could cause the price of our securities to fall.
Government restrictions on pricing and reimbursement, as well as other healthcare payor cost-containment initiatives, may negatively impact our ability to
generate revenues.
The continuing efforts of the government, insurance companies, managed care organizations and other payors of health care costs to contain or reduce costs
of health care may adversely affect one or more of the following:
•
•
•
our or our collaborators' ability to set a price we believe is fair for our products, if approved;
our ability to generate revenues and achieve profitability; and
the availability of capital.
The Patient Protection and Affordable Care Act and other potential legislative or regulatory action regarding healthcare and insurance matters, along with the
trend toward managed healthcare in the United States, could influence the purchase of healthcare products and reduce demand and prices for our products, if
approved. This could harm our or our collaborators' ability to market our potential medicines and generate revenues. Cost containment measures that health care
payors and providers are instituting and the effect of the Patient Protection and Affordable Care Act and further agency regulations that are likely to emerge in
connection with the passage of this act could significantly reduce potential revenues from the sale of any product candidates approved in the future. In addition, in
certain foreign markets, the pricing of prescription drugs is subject to government control and reimbursement may in some cases be unavailable. We believe that
pricing pressures at the state and federal level, as well as internationally, will continue and may increase, which may make it difficult for us to sell our potential
medicines that may be approved in the future at a price acceptable to us or our collaborators, which may cause our stock price to decline.
If we use hazardous and biological materials in a manner that causes injury or violates applicable law, we may be liable for damages.
Our research and development activities involve the controlled use of potentially hazardous substances, including chemical, biological and radioactive
materials. In addition, our operations produce hazardous waste products. Federal, state and local laws and regulations govern the use, manufacture, storage,
handling and disposal of hazardous materials. We may incur significant additional costs to comply with these and other applicable laws in the future. Also, even if
we are in compliance with
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applicable laws, we cannot completely eliminate the risk of contamination or injury resulting from hazardous materials and we may incur liability as a result of
any such contamination or injury. In the event of an accident, we could be held liable for damages or penalized with fines, and the liability could exceed our
resources. We do not have any insurance for liabilities arising from hazardous materials. Compliance with applicable environmental laws and regulations is
expensive, and current or future environmental regulations may impair our research, development and production efforts, which could harm our business, which
could cause the price of our securities to fall.
Risks Related to Ownership of our Common Stock
The price of our securities has been extremely volatile and may continue to be so, and purchasers of our securities could incur substantial losses.
The price of our securities has been extremely volatile and may continue to be so. The stock market in general and the market for biotechnology and
biopharmaceutical companies in particular have experienced extreme volatility that has often been unrelated to the companies' operating performance, in
particular during the last few years. The following factors, in addition to the other risk factors described in this section, may also have a significant impact on the
market price of our securities:
•
•
•
•
•
•
any adverse developments or results or perceived adverse developments or results with respect to the development of RELOVAIR™ with GSK,
including, without limitation, any difficulties or delays encountered with regard to the regulatory path for RELOVAIR™, delays in completing the
Phase 3 program in asthma or any indication from the Phase 3 programs that RELOVAIR™ is not safe or efficacious (for example, the investor
reaction to the topline results from the RELOVAIR™ Phase 3 registrational programs announced in early 2012);
any adverse developments or results or perceived adverse developments or results with respect to the LAMA/LABA ('719/VI) program with GSK,
including, without limitation, any difficulties or delays encountered with regard to the regulatory path for '719/VI, delays in completing the
Phase 3 studies or any indication from these studies that '719/VI is not safe or efficacious;
any adverse developments or results or perceived adverse developments or results with respect to the MABA program with GSK, including,
without limitation, any difficulties or delays encountered with regard to the regulatory path for '081 or any indication from ongoing non-clinical
studies of '081 that the compound is not safe or efficacious;
any further adverse developments with respect to the commercialization of VIBATIV®, including, without limitation, the uncertainties
surrounding drug product manufacture and supply and how, when and where VIBATIV® will be commercialized;
any further adverse developments or perceived adverse developments with respect to our telavancin NP NDA, which the FDA has determined
cannot be approved without data from additional clinical studies;
any adverse developments or perceived adverse developments in the field of LABAs, including any change in FDA policy or guidance (such as
the pronouncement in February 2010 warning that LABAs should not be used alone in the treatment of asthma and related labeling requirements,
the impact of the March 2010 FDA Advisory Committee discussing LABA clinical trial design to evaluate serious asthma outcomes or the FDA's
April 2011 announcement that manufacturers of currently marketed LABAs conduct additional clinical studies comparing the addition of LABAs
to inhaled corticosteroids versus inhaled corticosteroids alone);
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•
•
•
•
•
•
•
•
•
•
•
•
•
•
•
GSK's decisions whether or not to purchase from us, on a quarterly basis, sufficient shares of common stock to maintain its ownership percentage
taking into account our preceding quarter's option exercise and equity vesting activity;
any announcements of developments with, or comments by, the FDA or other regulatory authorities with respect to products we or our partners
have under development or have commercialized, such as the cGMP compliance issues that the single-source drug product supplier for
VIBATIV® is facing with U.S. and foreign regulatory authorities;
our incurrence of expenses in any particular quarter that are different than market expectations;
the extent to which GSK advances (or does not advance) RELOVAIR™, the LAMA/LABA program and the MABA program through
development into commercialization;
any adverse developments or perceived adverse developments with respect to our relationship with GSK, including, without limitation,
disagreements that may arise between us and GSK concerning the public announcement of data (both timing and content) from the Phase 3
programs with RELOVAIR™ and '719/VI and the MABA program;
any adverse developments or perceived adverse developments with respect to our partnering efforts with VIBATIV®, our 5-HT4, PµMA, MARIN
and ARNI programs, TD-1792 or TD-4208;
announcements regarding GSK generally;
announcements of patent issuances or denials, technological innovations or new commercial products by us or our competitors;
developments concerning any collaboration we may undertake with companies other than GSK;
publicity regarding actual or potential study results or the outcome of regulatory review relating to products under development by us, our partners
or our competitors;
regulatory developments in the United States and foreign countries;
economic and other external factors beyond our control;
sales of stock by us or by our stockholders, including sales by certain of our employees and directors whether or not pursuant to selling plans
under Rule 10b5-1 of the Securities Exchange Act of 1934;
relative illiquidity in the public market for our common stock (our six largest stockholders other than GSK collectively owned approximately
50.9% of our outstanding capital stock as of February 17, 2012); and
potential sales or purchases of our capital stock by GSK.
Concentration of ownership will limit your ability to influence corporate matters.
As of February 17, 2012, GSK beneficially owned approximately 18.4% of our outstanding capital stock and our directors, executive officers and investors
affiliated with these individuals beneficially owned approximately 6.58% of our outstanding capital stock. Based on our review of publicly available filings as of
February 17, 2012, our six largest stockholders other than GSK collectively owned approximately 50.9% of our outstanding capital stock. These stockholders
could control the outcome of actions taken by us that require stockholder approval, including a transaction in which stockholders might receive a premium over
the prevailing market price for their shares.
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Anti-takeover provisions in our charter and bylaws, in our rights agreement and in Delaware law could prevent or delay a change in control of our company.
Provisions of our certificate of incorporation and bylaws may discourage, delay or prevent a merger or acquisition that stockholders may consider favorable,
including transactions in which you might otherwise receive a premium for your shares. These provisions include:
•
•
•
•
requiring supermajority stockholder voting to effect certain amendments to our certificate of incorporation and bylaws;
restricting the ability of stockholders to call special meetings of stockholders;
prohibiting stockholder action by written consent; and
establishing advance notice requirements for nominations for election to the board of directors or for proposing matters that can be acted on by
stockholders at stockholder meetings.
In addition, our board of directors has adopted a rights agreement that may prevent or delay a change in control of us. Further, some provisions of Delaware
law may also discourage, delay or prevent someone from acquiring us or merging with us.
ITEM 1B. UNRESOLVED STAFF COMMENTS
None.
ITEM 2. PROPERTIES
Our headquarters are located in South San Francisco, CA, and consist of two leased buildings of approximately 110,000 and 40,000 square feet. The lease
expires in May 2020 and we may extend the terms for two additional five-year periods. The current annual rental expense under these leases is approximately
$6.7 million. As security for performance of certain obligations under the facility operating leases for our headquarters, we were required to have a financial
institution issue letters of credit in the aggregate of approximately $0.8 million, which we have collateralized with the financial institution by an equal amount of
restricted cash.
ITEM 3. LEGAL PROCEEDINGS
We are not a party to any material legal proceedings.
ITEM 4. MINE SAFETY DISCLOSURES
Not applicable.
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PART II
ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF
EQUITY SECURITIES
Our common stock has been traded on the Nasdaq Global Market under the symbol "THRX" since October 5, 2004. The following table sets forth the high
and low closing prices of our common stock on a per share basis for the periods indicated and as reported on the Nasdaq Global Market:
Calendar Quarter
2011
Fourth Quarter
Third Quarter
Second Quarter
First Quarter
2010
Fourth Quarter
Third Quarter
Second Quarter
First Quarter
High
Low
$ 23.91 $ 19.02
$ 24.87 $ 16.89
$ 28.70 $ 21.18
$ 25.78 $ 20.98
$ 28.64 $ 20.00
$ 20.10 $ 11.83
$ 17.15 $ 12.52
9.70
$ 13.85 $
As of February 17, 2012, there were 187 stockholders of record of our common stock. In July 2011, GSK converted all of the shares of our Class A common
stock held by its affiliates into 9,401,499 shares of our common stock on a one share-for-one share basis in accordance with the terms of our restated certificate of
incorporation. In addition, during 2011, Glaxo Group Limited, an affiliate of GSK, purchased a total of 574,454 shares of our common stock via private
placement for an aggregate purchase price of $13.6 million pursuant to its periodic "top-up" rights under our governance agreement with GSK dated June 4, 2004,
as amended. We issued and sold these shares in reliance upon an exemption from registration pursuant to Section 4(2) of the Securities Act of 1933, as amended.
Dividend Policy
We currently intend to retain any future earnings to finance our research and development efforts. We have never declared or paid cash dividends on our
common stock or Class A common stock and do not intend to declare or pay cash dividends on our common stock in the foreseeable future.
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Equity Compensation Plans
The following table provides certain information with respect to all of our equity compensation plans in effect as of December 31, 2011:
Plan Category
Equity compensation plans approved by security holders
Equity compensation plans not approved by security
holders
Total
Number of securities
to be issued upon
exercise of
outstanding options,
warrants and rights
(a)
7,906,129(1)
526,718(2)
(1)
(2)
8,432,847
$
$
$
Weighted-average
exercise price of
outstanding
options,
warrants and rights
(b)
19.18(3)
11.82(3)
Number of securities
remaining available
for future issuance
under equity
compensation plans
(excluding securities
reflected in
column (a))
(c)
2,646,644(4)
—
18.62(3)
2,646,644(4)
(1)
(2)
(3)
(4)
Includes 6,372,349 shares issuable upon exercise of outstanding options and 1,533,780 shares issuable upon vesting of outstanding
restricted stock units.
Includes 518,749 shares issuable upon exercise of outstanding options and 7,969 shares issuable upon vesting of outstanding restricted
stock units.
Does not take into account outstanding restricted stock units as these awards have no exercise price.
Includes 556,546 shares of common stock available under our Employee Stock Purchase Plan.
The Theravance, Inc. 2008 New Employee Equity Incentive Plan (2008 Plan) is a non-stockholder approved plan adopted by the Board of Directors (Board)
on January 29, 2009 and is intended to satisfy the requirements of Nasdaq Marketplace Rule 5635(c)(4). Non-statutory options, restricted stock units, and
restricted stock awards were granted under the 2008 Plan to our newly hired employees until April 27, 2010, the date on which stockholders approved our
amended and restated 2004 Equity Incentive Plan. No further awards will be granted under the 2008 Plan. The Board authorized 500,000 shares of common stock
for issuance under the 2008 Plan upon its adoption in 2008 and the Compensation Committee of the Board authorized an additional 200,000 shares for issuance
under the 2008 Plan in July 2009. All option grants have an exercise price per share of no less than 100% of the fair market value per share of common stock on
the grant date. Additional features of the 2008 Plan are outlined in Note 1, "Description of Operations and Summary of Significant Accounting Policies-Fair
Value of Stock-Based Compensation Awards," and Note 10, "Stock-Based Compensation," in the Notes to Consolidated Financial Statements below in Part II,
Item 8, "Financial Statements and Supplementary Data" of this Annual Report on Form 10-K.
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Stock Performance Graph
The graph set forth below compares the cumulative total stockholder return on our common stock for the period commencing on December 31, 2006 and
ending on December 31, 2011, with the cumulative total return of (i) the Nasdaq Composite Index and (ii) the NYSE Arca Biotechnology Index, over the same
period. This graph assumes the investment of $100.00 on December 31, 2006 in each of (1) our common stock, (2) the Nasdaq Composite Index and (3) the
NYSE Arca Biotechnology Index, and assumes the reinvestment of dividends, if any, although dividends have never been declared on our common stock.
The comparisons shown in the graph below are based upon historical data. We caution that the stock price performance shown in the graph below is not
necessarily indicative of, nor is it intended to forecast, the potential future performance of our common stock. Information used in the graph was obtained from
Research Data Group, Inc., a source believed to be reliable, but we are not responsible for any errors or omissions in such information.
Notwithstanding anything to the contrary set forth in any of our previous or future filings under the Securities Act of 1933, as amended, or the Securities
Exchange Act of 1934, as amended, that might incorporate this Annual Report on Form 10-K or future filings made by us under those statutes, this Stock
Performance Graph section shall not be deemed filed with the United States Securities and Exchange Commission and shall not be deemed incorporated by
reference into any of those prior filings or into any future filings made by us under those statutes.
COMPARISON OF 5 YEAR CUMULATIVE TOTAL RETURN*
Among Theravance, Inc., the NASDAQ Composite Index, and
the NYSE Arca Biotechnology Index
*
$100 invested on 12/31/06 in stock or index, including reinvestment of dividents.
Fiscal year ending December 31.
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ITEM 6. SELECTED FINANCIAL DATA
The following tables reflect selected consolidated summary financial data for each of the last five fiscal years and are derived from our audited financial
statements. This data should be read in conjunction with Part II, Item 7, "Management's Discussion and Analysis of Financial Condition and Results of
Operations" and Part II, Item 8, "Financial Statements and Supplementary Data", in this Annual Report on Form 10-K.
CONSOLIDATED STATEMENT OF OPERATIONS
DATA:
Revenue
Operating expenses:
Research and development
General and administrative
Restructuring charges
Total operating expenses(1)
Loss from operations
Interest and other income
Interest expense
Net loss
2011
Year Ended December 31,
2010
2008
2009
(in thousands, except per share data)
2007
$
24,512 $
24,223 $
24,374 $
23,096 $
22,002
77,524
27,066
1,145
105,735
75,070
27,476
—
102,546
103,568
30,681
—
134,249
(109,737)
155,254
35,313
—
190,567
(168,565)
8,661
(93)
$ (115,344) $ (83,862) $ (85,302) $ (93,643) $ (159,997)
82,020
28,861
5,419
116,300
(81,361)
2,111
(6,052)
(78,323)
505
(6,044)
(93,204)
5,242
(5,681)
415
(6,022)
Basic and diluted net loss per share
$
(1.41) $
(1.16) $
(1.35) $
(1.53) $
(2.64)
Shares used in computing basic and net loss per share(2)
(3)(4)
82,051
72,070
63,027
61,390
60,498
2011
2010
As of December 31,
2009
2008
2007
CONSOLIDATED BALANCE SHEET
DATA:
Cash, cash equivalents and marketable securities $
Working capital
Total assets
Long-term liabilities(5)(6)
Accumulated deficit
Total stockholders' equity (net capital deficiency)
240,915 $
199,267
258,782
300,338
(1,315,960)
(87,052)
309,634 $
276,300
331,202
313,568
(1,200,616)
(22,420)
155,390 $
123,096
181,393
331,441
(1,116,754)
(188,994)
200,605 $
166,006
236,156
327,150
(1,031,452)
(134,949)
129,272
78,554
161,983
172,714
(937,809)
(66,264)
(1)
The following table discloses the allocation of stock-based compensation expense included in total operating expenses:
(in thousands)
Research and development
General and administrative
Total stock-based compensation
2011
2010
Year Ended December 31,
2009
$ 13,421 $ 10,322 $ 11,542 $ 10,264 $ 13,133
9,361
$ 24,916 $ 19,009 $ 20,000 $ 18,019 $ 22,494
11,495
8,687
7,755
8,458
2008
2007
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(2)
(3)
(4)
(5)
(6)
In March 2010, we completed a public offering of 8,625,000 shares of common stock. The financing raised proceeds, net of issuance
costs, of $93.5 million.
In November 2010, we completed a private placement of 5,750,000 shares of common stock to Glaxo Group Limited, an affiliate of GSK.
The financing raised proceeds, net of issuance costs, of $129.2 million.
During 2011, Glaxo Group Limited, an affiliate of GSK, purchased a total of 574,454 shares of common stock pursuant to its rights under
our governance agreement with GSK dated June 4, 2004, as amended. The purchases resulted in proceeds of $13.6 million.
Long-term liabilities include the long-term portion of deferred revenue as follows:
(in thousands)
Deferred revenue
2011
2009
$ 122,017 $ 137,425 $ 157,426 $ 152,771 $ 166,136
2008
2007
2010
In January 2008, we completed a public offering of $172.5 million aggregate principal amount of unsecured convertible subordinated
notes which will mature on January 15, 2015. The financing raised proceeds, net of issuance costs, of $166.7 million.
ITEM 7. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS
Management's Discussion and Analysis (MD&A) is intended to facilitate an understanding of our business and results of operations. You should read the
following discussion and analysis of our financial condition and results of operations together with our consolidated financial statements and related notes
included in Item 8, "Financial Statements and Supplementary Data" in this Annual Report on Form 10-K. The information contained in this discussion and
analysis or set forth elsewhere in this Annual Report on Form 10-K, including information with respect to our plans and strategy for our business, includes
forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934,
as amended. Such statements are based upon current expectations that involve risks and uncertainties. You should review the section entitled "Risk Factors" in
Item 1A of Part I above for a discussion of important factors that could cause actual results to differ materially from the results described in or implied by the
forward-looking statements contained in the following discussion and analysis.
Executive Summary
Theravance is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic collaborations with pharmaceutical
companies. We are focused on the discovery, development and commercialization of small molecule medicines across a number of therapeutic areas including
respiratory disease, bacterial infections, and central nervous system (CNS)/pain. Our key programs include: RELOVAIR™, LAMA/LABA ('719/vilanterol (VI))
and MABA (Bifunctional Muscarinic Antagonist-Beta2 Agonist), each partnered with GlaxoSmithKline plc (GSK), and our oral Peripheral Mu Opioid Receptor
Antagonist (PµMA) program. By leveraging our proprietary insight of multivalency to drug discovery, we are pursuing a best-in-class strategy designed to
discover superior medicines in areas of significant unmet medical need.
Our net loss for the year ended December 31, 2011 was $115.3 million compared to $83.9 million in 2010. This increase was due primarily to higher
research and development expenses. Research and development expenses for the year ended December 31, 2011 increased to $103.5 million compared to
$75.1 million in 2010. This increase was driven primarily by higher external costs. Cash, cash equivalents, and short-term investments totaled $240.9 million at
December 31, 2011, a decrease of $68.7 million since December 31, 2010. The decrease was due primarily to cash used in operations,
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partially offset by net proceeds of $13.6 million received from sales of our common stock to an affiliate of GSK, net proceeds of $10.1 million received from
exercises of employee stock options, a $3.0 million milestone payment received from GSK for the initiation of a Phase 1 combination study in the MABA
program, a $1.0 million upfront license payment related to GSK's license of additional preclinical MABA compounds from us, and $2.4 million royalty revenue
from VIBATIV® sales.
Program Highlights
Respiratory Programs with GSK
RELOVAIR™
RELOVAIR™ is an investigational once-daily inhaled corticosteroid (ICS)/long-acting beta2 agonist (LABA) combination treatment, comprising fluticasone
furoate and vilanterol (FF/VI), currently in development for the treatment of patients with chronic obstructive pulmonary disease (COPD) or asthma.
In January 2012, we and GSK announced that GSK intends to commence global regulatory filings in COPD and asthma beginning in mid-2012 based upon
the initial outcomes from pivotal Phase 3 studies for once-daily RELOVAIR™ in COPD and asthma. For asthma, GSK will continue discussions with the U.S.
Food and Drug Administration (FDA) on the regulatory requirements for a U.S. asthma indication.
LAMA/LABA Combination (GSK573719/Vilanterol or '719/VI)
Enrollment is complete for the seven ongoing studies in the Phase 3 program for the once-daily long-acting muscarinic antagonist (LAMA)/LABA dual
bronchodilator '719/VI. '719/VI combines two bronchodilators currently under development—'719, a LAMA and VI, a LABA. These two molecules provide two
mechanisms of bronchodilation for patients with COPD: antagonism of acetylcholine muscarinic receptors and agonism of beta2 adrenoreceptors.
The LAMA/LABA Phase 3 program, which will evaluate over 5,000 patients with COPD globally, consists of a 52-week study to evaluate the long term
safety and tolerability of '719 (125mcg) alone, as well as the combination '719/VI (125/25mcg), two large 6-month pivotal studies that will compare
improvements in lung function between '719/VI, its components and placebo, two 6-month studies to compare the combination with its components and
tiotropium and two studies to assess the effect of '719/VI on exercise endurance. The Phase 3 program will investigate two doses of '719 (125mcg and 62.5mcg)
and two doses of the combination '719/VI (125/25mcg and 62.5/25mcg).
Inhaled Bifunctional Muscarinic Antagonist-Beta2 Agonist (MABA)
GSK961081 ('081), the lead compound in the MABA program with GSK, is a single molecule bifunctional bronchodilator with both muscarinic antagonist
and beta2 receptor agonist activity. In February 2012, we announced topline results from a Phase 2b COPD study with '081.
In October 2011, we and GSK amended the 2004 Strategic Alliance Agreement to expand the MABA program. We granted to GSK an exclusive license to
develop and commercialize additional preclinical MABA compounds discovered by Theravance. We received an upfront license payment of $1.0 million and
have the potential to receive clinical, regulatory and commercial milestone payments as well as royalties on worldwide net sales if one of these MABA
compounds is successfully commercialized.
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Bacterial Infections Program
VIBATIV® (telavancin) for injection
In November 2005, we entered into a global collaboration arrangement with Astellas for the development and commercialization of VIBATIV®. On
January 6, 2012, Astellas exercised its right to terminate this agreement. The rights granted to Astellas ceased upon termination of the agreement and Astellas has
stopped promotional sales efforts. Pursuant to the terms of the agreement, there are no termination payments required by either party and Astellas is entitled to a
ten-year, 2% royalty on future net sales of VIBATIV®. To support the transition, Astellas will sell inventory to us, manage certain clinical and regulatory
activities and respond to medical inquiries with respect to VIBATIV® until no later than March 31, 2012. We currently are focusing our efforts on evaluating
commercialization alternatives for VIBATIV®, including re-partnering, and re-establishing consistent VIBATIV® product supply.
Due to manufacturing issues at the single-source supplier of VIBATIV® drug product, VIBATIV® is currently subject to critical product shortages and
regional supply outages in the U.S., and the Committee for Medicinal Products for Human Use (CHMP) recommended to the European Commission that it
suspend marketing authorization for VIBATIV®. If the issues at the manufacturer are not promptly resolved, obtaining supply would require identifying and
qualifying an alternative manufacturer, which could take 12 to 24 months.
Central Nervous System (CNS)/Pain Program
Oral Peripheral Mu Opioid Receptor Antagonist (PµMA)—TD-1211
Enrollment is progressing in the Phase 2b program, which will assess the safety, tolerability and clinical activity of TD-1211 in patients with opioid-induced
constipation. This program is evaluating several doses and dose regimens to provide information for the design of the Phase 3 program. TD-1211 is an
investigational once-daily, orally-administered, peripherally selective, multivalent inhibitor of the mu opioid receptor designed to alleviate gastrointestinal side
effects of opioid therapy without affecting analgesia.
MonoAmine Reuptake INhibitor (MARIN)—TD-9855
In December 2011, we announced the initiation of an Attention-Deficit/Hyperactivity Disorder (ADHD) Phase 2 proof-of-concept study with TD-9855, the
lead compound in our MARIN program. This Phase 2 study will evaluate the safety and efficacy of two different doses of TD-9855 in adult male patients with
ADHD. TD-9855 is an investigational norepinephrine and serotonin reuptake inhibitor (NSRI) discovered by Theravance for the treatment of CNS conditions
such as ADHD and chronic pain.
Theravance Respiratory Program
Long-Acting Muscarinic Antagonist (LAMA)—TD-4208
In November 2011, we announced positive topline results from a Phase 2a single-dose COPD study of TD-4208, an investigational inhaled LAMA,
discovered by Theravance. In this study, TD-4208 met the primary endpoint by demonstrating a statistically significant mean change from baseline in peak forced
expiratory volume in one second (FEV1) compared to placebo and was generally well tolerated.
Other Programs
In addition to the programs listed above, we have other clinical-stage programs for bacterial infections, cognitive disorders and gastrointestinal motility.
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TD-1792 is our investigational heterodimer antibiotic that combines the antibacterial activities of a glycopeptide and a beta-lactam in one molecule. The goal
of our program with TD-1792 is to develop a next-generation antibiotic for the treatment of serious infections caused by Gram-positive bacteria.
In cognitive disorders, we are evaluating compound TD-5108 as a potential treatment for Alzheimer's disease. TD-5108 has successfully completed a
Phase 1 study assessing CNS penetration. Our Gastrointestinal (GI) Motility Dysfunction program is dedicated to finding new medicines for GI motility disorders
such as chronic idiopathic constipation (CIC) and other disorders related to reduced gastrointestinal motility. Our lead compound in this area is TD-5108, a highly
selective 5-HT4 receptor agonist that has successfully completed a 400 patient Phase 2 proof-of-concept study in CIC. The back-up compound in this program,
TD-8954, has completed single-ascending and multiple-ascending dose Phase 1 studies.
Critical Accounting Policies
This discussion and analysis of our financial condition and results of operations is based on our consolidated financial statements, which have been prepared
in accordance with U.S. generally accepted accounting principles. The preparation of these financial statements requires us to make estimates and assumptions
that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements as well as the
reported revenue and expenses during the reporting periods. We periodically evaluate our material estimates and judgments based on the terms of underlying
agreements, the expected course of development, historical experience and other factors that we believe are reasonable under the circumstances. Actual results
may differ from these estimates under different assumptions or conditions.
While our significant accounting policies are more fully described in Note 1, "Description of Operations and Summary of Significant Accounting Policies,"
in the Notes to our consolidated financial statements contained in Part II, Item 8, "Financial Statements and Supplementary Data" in this Annual Report on
Form 10-K, we believe that the following accounting policies relating to revenue recognition, preclinical study and clinical study expenses, stock-based
compensation charges and inventory require us to make significant estimates, assumptions and judgments.
Revenue Recognition
We recognize revenue in accordance with the Financial Accounting Standards Board (FASB) Subtopic ASC 605-25, "Revenue Recognition—Multiple-
Element Arrangements." As of January 1, 2011, we adopted on a prospective basis the accounting updates to guidance ASC 605 "Revenue Recognition", subtopic
ASC 605-25 "Revenue with Multiple Element Arrangements" and subtopic ASC 605-28 "Revenue Recognition-Milestone Method", which provides accounting
guidance for revenue recognition for arrangements with multiple deliverables and guidance on defining the milestone and determining when the use of the
milestone method of revenue recognition for research and development transactions is appropriate, respectively. The adoption of ASC 605-25 "Revenue with
Multiple Element Arrangements" and the election of the milestone method under subtopic ASC 605-28 "Revenue Recognition-Milestone Method" did not have a
material impact on our consolidated financial statements. However, these updates will result in different accounting treatment for future new collaboration
arrangements and substantive milestones earned after the dates of adoption.
Our revenues are related primarily to our collaboration arrangements with GSK and our collaboration agreement with Astellas, which was in effect through
January 6, 2012 (see Collaboration Arrangements section below). Our arrangements provide for various types of payments to us, including non-refundable
upfront license and other fees, milestone payments and royalty payments. We recognize revenue when persuasive evidence of an arrangement exists, delivery has
occurred or services have been rendered, the price is fixed or determinable, and collectability is reasonably assured.
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For multiple-element arrangements entered into prior to January 1, 2011, we determined that the deliverables under our collaboration agreements with GSK
and Astellas did not meet the criteria required for separate accounting units for the purposes of revenue recognition. As a result, we recognized revenue from non-
refundable, upfront fees and development milestone payments ratably over the term of its performance under the agreements. These upfront or milestone
payments received, pending recognition as revenue, are recorded as deferred revenue and are classified as a short-term or long-term liability on the balance sheet
to be amortized over the period of deferral. We periodically review the estimated performance periods of our contracts based on the progress of its programs.
In accordance with ASC Subtopic 808-10, "Collaborative Arrangement," and pursuant to our agreement with Astellas, we recognized as revenue the net
impact of transactions with Astellas related to VIBATIV® inventory including revenue specifically attributable to any sales, and cost of inventory either
transferred or expensed as unrealizable.
We have recognized royalty revenue on net sales in the period in which the royalties are earned based on net sales reporting provided by Astellas, our former
collaborative partner for VIBATIV®.
We have been reimbursed by GSK and Astellas for certain external development costs under their respective collaboration agreements. Such reimbursements
have been reflected as a reduction of research and development expense and not as revenue.
For multiple-element arrangements entered into, or materially modified, subsequent to January 1, 2011, each deliverable within a multiple deliverable
revenue arrangement is accounted for as a separate unit of accounting if both of the following criteria are met: (1) the delivered item or items have value to the
customer on a standalone basis and (2) for an arrangement that includes a general right of return relative to the delivered item(s), delivery or performance of the
undelivered item(s) is considered probable and substantially in our control.
In addition, multiple deliverable revenue arrangement consideration is allocated at the inception of an arrangement to all deliverables using the relative
selling price method. We also apply a selling price hierarchy for determining the selling price of a deliverable, which includes (1) vendor-specific objective
evidence, if available, (2) third-party evidence, if vendor-specific objective evidence is not available, and (3) estimated selling price if neither vendor-specific nor
third-party evidence is available.
Where a portion of non-refundable upfront license or other payments, or milestone payments received are allocated to continuing performance obligations
under the terms of a collaboration agreement, it will be recorded as deferred revenue and recognized as revenue ratably over the term of its estimated performance
period under the agreement. We determine the estimated performance periods and they are periodically reviewed based on the progress of the related program.
The effect of a change made to an estimated performance period and therefore revenue recognized ratably would occur on a prospective basis in the period that
the change was made.
Deferred revenue associated with a non-refundable payment received under a collaborative agreement that the performance obligations are terminated will
result in an immediate recognition of any remaining deferred revenue in the period that termination occurred provided that all performance obligations have been
satisfied.
For milestones earned after January 1, 2011, we recognize revenue from milestone payments when: (i) the milestone event is substantive and its achievability
was not reasonably assured at the inception of the agreement, and (ii) we do not have ongoing performance obligations related to the achievement of the
milestone earned. Milestone payments are considered substantive if all of the following conditions are met: the milestone payment (a) is commensurate with
either our performance to achieve the milestone or the enhancement of the value of the delivered item or items as a result of a specific outcome resulting from our
performance to achieve the milestone, (b) relates solely to past performance, and (c) is reasonable relative to all of the deliverables and payment terms (including
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other potential milestone consideration) within the arrangement. See Note 3, "Collaboration Arrangements," in the Notes to the Consolidated Financial
Statements below in part II, Item 8, "Financial Statements and Supplementary Data" on this Annual Report on Form 10-K, for analysis of each milestone event
deemed to be substantive or non-substantive.
Preclinical Study and Clinical Study Expenses
A substantial portion of our preclinical studies and all of our clinical studies have been performed by third-party contract research organizations (CROs).
Some CROs bill monthly for services performed, while others bill based upon milestones achieved. We review the activities performed under the significant
contracts each quarter. For preclinical studies, the significant factors used in estimating accruals include the percentage of work completed to date and contract
milestones achieved. For clinical study expenses, the significant factors used in estimating accruals include the number of patients enrolled and percentage of
work completed to date. Vendor confirmations are obtained for contracts with longer duration when necessary to validate our estimate of expenses. Our estimates
are highly dependent upon the timeliness and accuracy of the data provided by our CROs regarding the status of each program and total program spending and
adjustments are made when deemed necessary. To date, we have not recorded any material adjustments as a result of changes to our estimates.
Stock-Based Compensation
Stock-based compensation arrangements currently include stock options granted, restricted stock unit awards (RSUs) granted and restricted shares issued
RSAs) under the 2004 Equity Incentive Plan (2004 Plan) and the 2008 New Employee Equity Incentive Plan (2008 Plan) and purchases of common stock by our
employees at a discount to the market price during offering periods under our Employee Stock Purchase Plan (ESPP). Non-statutory options, RSUs, and RSAs
were granted under the 2008 Plan to our newly hired employees until April 27, 2010, the date on which stockholders approved our amended and restated 2004
Plan. No further awards will be granted under the 2008 Plan.
We use the Black-Scholes option pricing model to estimate the fair value of options granted under our equity incentive plans and rights to acquire stock
granted under our employee stock purchase plan. The Black-Scholes option valuation model requires the use of assumptions, including the expected term of the
award and the expected stock price volatility. We use the "simplified" method as described in Staff Accounting Bulletin No. 107 for the expected option term
because the usage of our historical exercise data is limited due to post-IPO exercise restrictions. Since April 1, 2011, we have used our historical volatility to
estimate expected stock price volatility. Prior to April 1, 2011, we used peer company price volatility to estimate expected stock price volatility due to our limited
historical common stock price volatility since its initial public offering in 2004. Restricted stock units (RSUs) and stock awards are measured based on the fair
market values of the underlying stock on the dates of grant.
The estimated fair value of stock options, RSUs and RSAs are expensed on a straight-line basis over the expected term of the grant and the fair value of
performance-contingent RSUs and performance-contingent RSAs are expensed during the term of the award when we determine that it is probable that certain
performance milestones will be achieved. Compensation expense for purchases under the ESPP is recognized based on the estimated fair value of the common
stock during each offering period and the percentage of the purchase discount.
Stock-based compensation expense for stock options, RSUs and RSAs has been reduced for estimated forfeitures so that compensation expense is based on
options, RSUs and RSAs ultimately expected to vest. We estimate annual forfeiture rates for stock options, RSUs and RSAs based on our historical forfeiture
experience.
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See Note 10, "Stock-Based Compensation," in the Notes to Consolidated Financial Statements in Part II, Item 8, "Financial Statements and Supplementary
Data" of this Annual Report on Form 10-K, for more information.
Inventory
Inventory is stated at the lower of cost or market value and is included in prepaid and other current assets. Inventory was comprised of VIBATIV® active
pharmaceutical ingredient. VIBATIV® has a limited shelf life. During the quarter ended December 31, 2011, we expensed all remaining inventory at an average
cost basis of $0.5 million as it was no longer realizable.
Collaboration Arrangements
GSK
LABA collaboration with GSK
In November 2002, we entered into our LABA collaboration with GSK to develop and commercialize once-daily LABA products for the treatment of COPD
and asthma. For the treatment of COPD, the collaboration is developing combination products, RELOVAIR™ and the LAMA/LABA '719/VI. For the treatment
of asthma, the collaboration is developing RELOVAIR™. RELOVAIR™ is an investigational once-daily combination medicine consisting of a LABA, VI,
previously referred to as GW642444 or '444, and an ICS, fluticasone furoate (FF). The LAMA/LABA, '719/VI, is an investigational once-daily combination
medicine consisting of the LAMA, '719, and the LABA, VI. The RELOVAIR™ program is aimed at developing a once-daily combination LABA/ICS to succeed
GSK's Advair®/Seretide™ (salmeterol and fluticasone as a combination) franchise, which reported 2011 sales of approximately $8.1 billion, and to compete with
Symbicort® (formoterol and budesonide as a combination), which reported 2011 sales of approximately $3.1 billion. '719/VI, which is also a combination
product, is targeted as an alternative treatment option to Spiriva® (tiotropium), a once-daily, single-mechanism bronchodilator, which reported 2010 sales of
approximately $3.8 billion.
The current lead product candidates in the LABA collaboration, VI and FF, were discovered by GSK. In the event that VI is successfully developed and
commercialized, we will be obligated to make milestone payments to GSK which could total as much as $220.0 million if both a single-agent and a combination
product or two different combination products are launched in multiple regions of the world. If global regulatory authorities accept the applications for
RELOVAIR™, which we anticipate will be filed by GSK beginning in mid-2012, a portion of these potential milestone payments could be payable to GSK within
the next two years. We are entitled to annual royalties from GSK of 15% on the first $3.0 billion of annual global net sales and 5% for all annual global net sales
above $3.0 billion. Sales of single-agent LABA medicines and combination medicines would be combined for the purposes of this royalty calculation. For other
products combined with a LABA from the LABA collaboration, such as '719/VI, royalties are upward tiering and range from the mid-single digits to 10%.
However, if GSK is not selling a LABA/ICS combination product at the time that the first other LABA combination is launched, then the royalties described
above for the LABA/ICS combination medicine would be applicable.
In connection with the LABA collaboration, in 2002, Glaxo Group Limited, an affiliate of GSK, purchased shares of our Series E preferred stock for an
aggregate purchase price of $40.0 million.
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2004 Strategic Alliance with GSK
In March 2004, we entered into our strategic alliance with GSK. Under this alliance, GSK received an option to license exclusive development and
commercialization rights to product candidates from certain of our discovery programs on pre-determined terms and on an exclusive, worldwide basis. Upon
GSK's decision to license a program, GSK is responsible for funding all future development, manufacturing and commercialization activities for product
candidates in that program. In addition, GSK is obligated to use diligent efforts to develop and commercialize product candidates from any program that it
licenses. If the program is successfully advanced through development by GSK, we are entitled to receive clinical, regulatory and commercial milestone
payments and royalties on any sales of medicines developed from the program. If GSK chooses not to license a program, we retain all rights to the program and
may continue the program alone or with a third party.
In 2005, GSK licensed our MABA program for the treatment of COPD, and in October 2011, we and GSK expanded the MABA program by adding six
additional Theravance-discovered preclinical MABA compounds (the "Additional MABAs"). GSK's development, commercialization, milestone and royalty
obligations under the strategic alliance remain the same with respect to '081, the lead compound in the MABA program. GSK is obligated to use diligent efforts to
develop and commercialize at least one MABA within the MABA program, but may terminate progression of any or all Additional MABAs at any time and
return them to us, at which point we may develop and commercialize such Additional MABAs alone or with a third party. Both GSK and we have agreed not to
conduct any MABA clinical studies outside of the strategic alliance so long as GSK is in possession of the Additional MABAs. If a single-agent MABA medicine
containing '081 is successfully developed and commercialized, we are entitled to receive royalties from GSK of between 10% and 20% of annual global net sales
up to $3.5 billion, and 7.5% for all annual global net sales above $3.5 billion. If a MABA medicine containing '081 is commercialized only as a combination
product, such as a MABA/ICS, the royalty rate is 70% of the rate applicable to sales of the single-agent MABA medicine. For single-agent MABA medicines
containing an Additional MABA, we are entitled to receive royalties from GSK of between 10% and 15% of annual global net sales up to $3.5 billion, and 10%
for all annual global net sales above $3.5 billion. For combination products containing an Additional MABA, such as a MABA/ICS, the royalty rate is 50% of the
rate applicable to sales of the single-agent MABA medicine. If a MABA medicine containing '081 is successfully developed and commercialized in multiple
regions of the world, we could earn total milestone payments up to $125.0 million for a single-agent medicine and up to $250.0 million for both a single-agent
and a combination medicine. If a MABA medicine containing an Additional MABA is successfully developed and commercialized in multiple regions of the
world, we could earn total milestone payments up to $129.0 million.
In connection with the expansion of the MABA program, GSK relinquished its option right on our MonoAmine Reuptake Inhibitor (MARIN) program and
Angiotensin Receptor-NEP Inhibitor (ARNI) program. GSK has no further option rights on any of our research or development programs under the strategic
alliance.
In May 2004, GlaxoSmithKline LLC, an affiliate of GSK, purchased 6,387,096 shares of our Class A common stock for an aggregate purchase price of
$108.9 million and, upon the closing of our initial public offering on October 8, 2004, GlaxoSmithKline LLC purchased an additional 433,757 shares of Class A
common stock for an aggregate purchase price of $6.9 million. In November 2010 Glaxo Group Limited, an affiliate of GSK, purchased 5,750,000 shares of our
Common Stock for an aggregate purchase price of $129.4 million.
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GSK Conversion of our Class A Common Stock and Purchases of Common Stock under our Governance Agreement with GSK
In July 2011, GSK converted all of the shares of our Class A common stock held by its affiliates into 9,401,499 shares of our common stock on a one share-
for-one share basis in accordance with the terms of our restated certificate of incorporation. In addition, Glaxo Group Limited purchased shares of our common
stock pursuant to its periodic "top-up" rights under our governance agreement with GSK dated June 4, 2004, as amended, as follows:
Purchase dates
February 24, 2011
May 3, 2011
August 2, 2011
November 1, 2011
Through December 31, 2011
Common Stock
Shares Purchased
Aggregate Amounts
(in thousands)
152,278 $
261,299 $
102,466 $
58,411 $
3,609
6,689
2,020
1,298
GSK Upfront License Fees, Milestone Payments and Revenue
In August 2011, we received a $3.0 million milestone payment from GSK for the initiation of the Phase 1 combination study in our MABA program.
In October 2011, we received an upfront license payment of $1.0 million from GSK related to the Additional MABAs, which is being accounted for as a new
arrangement under the updated multiple element arrangement accounting guidance. We allocated revenue from this upfront license payment and will allocate any
potential contingent payments related to the Additional MABAs under the MABA program, as discussed above in the section entitled Critical Accounting
Policies—Revenue Recognition, to each non-contingent element based upon the relative selling price of each element. We determined the license has standalone
value because the license can be used for its intended purpose and may be developed, commercialized and manufactured for its intended purpose without any
remaining participation from us. As a result, we recognized $936,000 of the upfront license payment and the remaining amount was deferred and will be
amortized over the estimated development period over which we will be performing services.
Any eligible potential contingent payments related to the MABA program are not deemed substantive due to the fact that the achievement of the event
underlying the payment predominantly relates to GSK's performance of future development, manufacturing and commercialization activities for product
candidates after licensing the program.
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Revenue recognized from GSK under the LABA collaboration and strategic alliance agreement was as follows:
(in millions)
LABA/RELOVAIR™ collaboration(1)
Strategic alliance agreement
Strategic alliance—LAMA license
Strategic alliance—MABA program license(2)
Total revenue
Year Ended
December 31,
2010
2009
2011
$ 4.7 $ 5.1 $
5.1
2.7
4.3
3.0
$ 9.7 $ 9.8 $ 15.1
1.9
—
3.1
2.7
—
2.0
(1)
(2)
In the fourth quarter of 2011, we revised the estimated performance period for the LABA program based on its progress. We do
not expect that the revisions will have a material impact on future revenue recognized under this program.
In the fourth quarter of 2011 and the first quarter of 2010, we revised the estimated performance period for the MABA program
based on its progress. We do not expect that the revisions will have a material impact on future revenue recognized under this
program
Astellas
In November 2005, we entered into a global collaboration arrangement with Astellas for the development and commercialization of VIBATIV®. On
January 6, 2012, Astellas exercised its right to terminate this agreement. The rights granted to Astellas ceased upon termination of the agreement and Astellas has
stopped promotional sales efforts. Pursuant to the terms of the agreement, there are no termination payments required by either party and Astellas is entitled to a
ten-year, 2% royalty on future net sales of VIBATIV®. To support the transition, Astellas will sell inventory to us, manage certain clinical and regulatory
activities and respond to medical inquiries with respect to VIBATIV® until no later than March 31, 2012. We are evaluating global commercialization alternatives
for VIBATIV® either alone or with partners.
VIBATIV® (telavancin), a bactericidal, once-daily injectable antibiotic developed by us for the treatment of Gram-positive infections. The FDA has
approved VIBATIV® for the treatment of complicated skin and skin structure infections (cSSSI) caused by susceptible Gram-positive bacteria including both
methicillin-resistant (MRSA) and methicillin-susceptible strains of Staphylococcus aureus in adult patients. VIBATIV® is also approved in Canada for the
treatment of cSSSI in adult patients. In September 2011, the European Commission granted marketing authorization for VIBATIV® for the treatment of adults
with nosocomial pneumonia, including ventilator-associated pneumonia, known or suspected to be caused by MRSA when other alternatives are not suitable.
However, in February 2012 the Committee for Medicinal Products for Human Use (CHMP) recommended to the European Commission that it suspend this
marketing authorization because the single-source drug product supplier does not meet the Good Manufacturing Practice (GMP) requirements to allow the
manufacture of VIBATIV®.
Due to manufacturing issues at the single-source supplier of VIBATIV® drug product, VIBATIV® is currently subject to critical product shortages and
regional supply outages in the U.S. If the issues at the manufacturer are not promptly resolved, obtaining supply would require identifying and qualifying an
alternative manufacturer, which could take 12 to 24 months.
Through December 31, 2011, we have received $191.0 million in upfront license, milestone and other fees from Astellas. We recorded these payments as
deferred revenue and are amortizing them ratably over our estimated performance period (development and commercialization period). As a
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result of the termination of the VIBATIV® collaboration agreement in January 2012, we are no longer eligible to receive any further milestone payments.
Net revenue recognized under this collaboration agreement was as follows:
(in millions)
Amortization of deferred revenue
Royalties from net sales of VIBATIV®
Proceeds from VIBATIV® delivered to Astellas
Cost of VIBATIV® delivered to Astellas
Cost of unrealizable VIBATIV® inventory
Total net revenue
2011
2009
Year Ended December 31,
2010
$ 13.0 $ 13.0 $ 11.3
0.8
—
(1.6)
(1.2)
9.3
1.1
2.0
(0.9)
(0.8)
$ 14.9 $ 14.4 $
2.4
1.2
(1.2)
(0.5)
Results of Operations
Revenue
Revenue, as compared to the prior years, was as follows:
(in millions, except percentages)
Revenue
Year Ended
December 31,
2010
2011
2009
Change
2011/2010
$
Change
2010/2009
$
%
%
1% $ (0.2) (1)%
$ 24.5 $ 24.2 $ 24.4 $ 0.3
We recognize revenue from the amortization of upfront license fees and milestone payments related to our GSK LABA collaboration and strategic alliance
agreements and our Astellas telavancin collaboration, which was terminated on January 6, 2012. In addition, we recognized revenue related to our Astellas
telavancin collaboration from royalties from net sales of VIBATIV® and from the impact of VIBATIV® inventory transfers or dispositions.
Revenue increased to $24.5 million in 2011 compared to 2010. This increase was due primarily to an (i) increase in royalty revenue of $1.3 million from
higher net sales of VIBATIV®, (ii) an increase in revenue related to our GSK MABA program of $1.1 million reflecting primarily the Additional MABA upfront
license fee, and (iii) a decrease in expense of $0.3 million related to VIBATIV® inventory that was no longer realizable. These increases in 2011 were partially
offset by (i) a decrease in revenue related to our GSK strategic alliance agreement of $0.8 million resulting from the deferred revenue being fully amortized in the
third quarter of 2011, (ii) a decrease in net proceeds of $1.1 million in 2011, compared to 2010, related to the delivery of VIBATIV® to Astellas, and (iii) a
decrease in revenue of $0.4 million in 2011, compared to 2010, resulting from a change in the estimated performance period related to our GSK LABA
collaboration.
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Upfront license fees and milestone payments received from GSK under the LABA collaboration and strategic alliance agreements and from Astellas under
the telavancin collaboration were as follows:
(in millions)
GSK Collaborations
LABA/RELOVAIR™ collaboration(1)
Strategic alliance agreement
Strategic alliance—LAMA license(2)
Strategic alliance—MABA program license
Astellas License agreement(3)
Total
Through December 31, 2011
Upfront
license and
Other Fees
Milestone
Payments
Total
$
$
10.0 $
20.0
5.0
6.0
70.0
111.0 $
60.0
50.0 $
20.0
—
8.0
3.0
22.0
16.0
121.0
191.0
190.0 $ 301.0
(1)
(2)
(3)
We do not currently expect to be eligible for any additional milestones under this collaboration.
In August 2004, GSK exercised its right to license our LAMA program pursuant to the terms of the strategic alliance. In 2009,
GSK returned the program to us.
This agreement was terminated on January 6, 2012.
As a result of the termination of the VIBATIV® collaboration agreement with Astellas, future revenue from Astellas will be comprised of recognition in the
first quarter of 2012 of the remaining non-cash, deferred upfront license fees and milestone payments, net of any estimated termination obligations, of
approximately $125.0 million. Future revenue from GSK will include ongoing amortization of upfront license fees and milestone payments over their estimated
performance periods. We periodically review and, if necessary, revise the estimated performance periods pursuant to these contracts.
Research & Development
Research and development (R&D) expenses, as compared to the prior years, were as follows:
(in millions, except percentages)
Employee-related
External research and development
Stock-based compensation
Facilities, depreciation and other allocated
Total research and development expenses
Year Ended
December 31,
2010
2011
2009
Change
2011/2010
$
Change
2010/2009
$
$
35.5 $ 30.4 $ 29.3 $
30.8
13.4
23.8
5.2
18.6
3.1
1.6
$ 103.5 $ 75.1 $ 77.5 $ 28.5
12.2
10.3
22.2
13.8
11.5
22.9
%
17% $
152%
30%
7%
%
1.1
4%
(1.6) (12)%
(1.2) (10)%
(3)%
(0.7)
(3)%
38% $ (2.4)
R&D expenses increased in 2011 compared to 2010, due primarily to clinical costs related to our PµMA and MARIN programs, laboratory supplies, and
higher employee related expenses in 2011.
R&D expenses decreased in 2010 compared to 2009, due primarily to lower external costs in 2010, partially offset by lower reimbursements received from
third parties in 2010. Employee-related expenses increased in 2010 compared to 2009 due primarily to higher salary and benefits costs. Stock-based
compensation decreased in 2010 compared to 2009, due primarily to a larger number of options that completed vesting in 2009.
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During the first quarter of 2011, we granted special long-term retention and incentive equity awards to executive officers and certain employees and special
long-term retention and incentive cash bonus awards to certain employees. The vesting of these awards is tied to the achievement of certain performance
conditions over a six-year timeframe from 2011 through December 31, 2016 and continued employment, both of which must be satisfied in order for vesting to
occur. The maximum potential expense for R&D associated with this program is $6.3 million related to stock-based compensation expense and $35.4 million
related to cash bonus expense, which would be recognized in increments based on achievement of the performance conditions. During the third quarter of 2011,
we granted an incentive equity award to a non-executive officer that has dual triggers of vesting based upon the achievement of a performance condition over a
timeframe from 2011-2013 and continued employment through 2014, both of which must be satisfied in order for the award to vest in full. The maximum
potential expense for R&D associated with this award is approximately $475,000, which would be recognized in increments based on achievement of the
performance conditions. As of December 31, 2011, we determined that the achievement of the performance conditions under these awards was not probable and,
as a result, no compensation expense has been recognized. Management believes that the likelihood of achieving all of the performance conditions under these
awards is remote.
We anticipate R&D expenses for 2012 to increase relative to 2011. R&D expenses in 2012 will be driven largely by employee related expenses, costs
associated with our continued development efforts in our PµMA program for opioid-induced constipation with TD-1211, our MARIN program with TD-9855,
and costs associated with our earlier stage clinical programs and our Hepatitis C virus (HCV) and cardiovascular programs in late-stage discovery, as well as new
drug discovery programs. We have not provided program costs in detail because we do not track, and have not tracked, all of the individual components
(specifically the internal cost components) of our research and development expenses on a program basis. We do not have the systems and processes in place to
accurately capture these costs on a program basis.
General & Administrative
General and administrative (G&A) expenses, as compared to the prior years, were as follows:
(in millions, except percentages)
General and administrative
Year Ended
December 31,
2010
2011
2009
Change
2011/2010
$
%
Change
2010/2009
$
$ 30.7 $ 27.5 $ 27.1 $ 3.2
12% $ 0.4
%
1%
G&A expenses increased in 2011 compared to 2010, due primarily to higher employee related and external expenses offset by lower facilities related costs.
G&A expenses increased in 2010 compared to 2009, due primarily to higher salary and benefits costs partially offset by lower external costs.
During the first quarter of 2011, we granted special long-term retention and incentive equity awards to executive officers and certain employees and special
long-term retention and incentive cash bonus awards to certain employees. The vesting of these awards is tied to the achievement of certain performance
conditions over a six-year timeframe from 2011 through December 31, 2016 and continued employment, both of which must be satisfied in order for the vesting
to occur. The maximum potential expense for G&A associated with this program is $25.6 million related to stock-based compensation expense and $4.4 million
related to cash bonus expense, which would be recognized in increments based on achievement of the performance conditions. As of December 31, 2011, we
determined that the achievement of the requisite performance conditions was not probable and, as a result, no compensation expense has been recognized.
Management believes that the likelihood of achieving all of the performance conditions is remote.
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We anticipate G&A expenses for 2012 to be at a similar level to 2011.
Restructuring charges
Restructuring charges, as compared to the prior years, were as follows:
(in millions, except percentages)
Restructuring charges
Year Ended
December 31,
2010
Change
2011/2010
$
$ — $ — $ 1.1 $ — N/A $ (1.1) (100)%
Change
2010/2009
$
%
%
2009
2011
In 2009, we recognized restructuring charges for the sublease of excess space in a portion of one of our South San Francisco, CA buildings.
Interest and other income
Interest and other income, as compared to the prior years, were as follows:
(in millions, except percentages)
Interest and other income
Year Ended
December 31,
2010
Change
2011/2010
$
$ 0.4 $ 0.5 $ 2.1 $ (0.1) (20)% $ (1.6) (76)%
Change
2010/2009
$
%
%
2009
2011
Interest and other income decreased in 2011 compared to 2010, and in 2010 compared to 2009, due primarily to a trend of lower prevailing rates of interest
income earned on our investments.
Interest expense
Interest expense, as compared to the prior years, was as follows:
(in millions, except percentages)
Interest expense
Year Ended
December 31,
2010
Change
2011/2010
%
$
$ 6.0 $ 6.0 $ 6.1 $ (0) (0)% $ (0.1) (2)%
Change
2010/2009
$
%
2009
2011
Interest expense is comprised primarily of interest expense and amortization of debt issuance costs on our convertible subordinated notes issued in January
2008.
Income Taxes
At December 31, 2011, we had net operating loss carryforwards for federal income taxes of $1,068.2 million and federal research and development tax credit
carryforwards of $43.2 million. We recorded a valuation allowance to offset in full the benefit related to our deferred tax assets because realization of these
benefits is uncertain.
We had unrecognized tax benefits of $42.6 million as of December 31, 2010 and $46.9 million as of December 31, 2011. If we eventually are able to
recognize these uncertain positions, most of the $46.9 million of the unrecognized benefit would reduce the effective tax rate, except for excess tax benefits
related to stock-based payments.
Utilization of net operating loss and tax credit carryforwards may be subject to a substantial annual limitation due to the ownership change limitations
provided by the Internal Revenue Code and similar state provisions. We conducted an analysis through 2011 to determine whether an ownership change had
occurred since inception. The analysis indicated that two ownership changes occurred in prior years. However, notwithstanding the applicable annual limitations,
we estimate that no portion of the net operating loss or credit carryforwards will expire before becoming available to reduce federal and
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state income tax liabilities. Annual limitations may result in expiration of net operating loss and tax credit carryforwards before some or all of such amounts have
been utilized.
Liquidity and Capital Resources
Liquidity
Since our inception, we have financed our operations primarily through private placements and public offerings of equity and debt securities and payments
received under corporate collaboration arrangements. As of December 31, 2011, we had $240.9 million in cash, cash equivalents and marketable securities,
excluding $0.9 million in restricted cash that was pledged as collateral for certain of our leases.
We expect to incur substantial expenses as we continue our discovery and development efforts; particularly to the extent we advance our product candidates
into clinical studies, which are very expensive. A Phase 2b program is underway in our PµMA program and we initiated a Phase 2 study for MARIN in late 2011.
We also intend to invest in other assets in our pipeline, including our Hepatitis C virus (HCV) and cardiovascular programs in late-stage discovery, and to conduct
a number of other non-clinical and clinical studies in 2012. On January 6, 2012, Astellas exercised its right to terminate our collaboration agreement for
VIBATIV®. Pursuant to the terms of the termination agreement, we may purchase certain VIBATIV® inventory from Astellas in 2012. The purchase is subject to
release of the inventory by a third-party manufacturer and may cost up to $11.0 million. We believe that our cash, cash equivalents and marketable securities will
be sufficient to meet our anticipated operating needs for at least the next twelve months based upon current operating plans, milestone and royalty forecasts and
spending assumptions. If our current operating plans, milestone and royalty forecasts or spending assumptions change, we may require additional funding sooner
in the form of public or private equity offerings or debt financings. Furthermore, if in our view favorable financing opportunities arise, we may seek additional
funding at any time. However, future financing may not be available in amounts or on terms acceptable to us, if at all. This could leave us without adequate
financial resources to fund our operations as presently conducted. In addition, we regularly explore debt restructuring and/or reduction alternatives, including
through tender offers, redemptions, repurchases or otherwise, all consistent with the terms of our debt agreements.
Cash Flows
(in millions)
Net cash used in operating activities
Net cash provided by (used in) investing activities
Net cash provided by financing activities
2011
Year Ended
December 31,
2010
$ (88.3) $ (75.1) $ (58.1) $
1.7 $
$ (55.8) $ (40.3) $
11.6 $
25.6 $ 231.2 $
$
2009
Change
2011/2010
$
(13.2) $
(15.5) $
(205.6) $
Change
2010/2009
$
(17.0)
(42.0)
219.6
Cash used in operations increased in 2011, compared to 2010, due primarily to higher uses of cash for operating liabilities.
Cash used in investing activities increased in 2011, compared to 2010, resulting primarily from higher cash balances being invested in short-term
investments during 2011, compared to 2010.
Cash provided by financing activities decreased in 2011, compared to 2010, due primarily to net proceeds of $129.2 million received from our private equity
placement with GSK in November 2010, net proceeds of $93.5 million received from our public offering of common stock that closed in March 2010 and
$2.7 million in Qualifying Therapeutic Discovery Project Grants received from the National Institute of Health in December 2010. This decrease was partially
offset by proceeds of $13.6 million received from sales of our common stock to an affiliate of GSK throughout 2011, an increase in
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proceeds of $3.7 million resulting from the exercises of employee stock options in 2011, a $3.0 million milestone payment received from GSK for the initiation of
a Phase 1 combination study in the MABA program in August 2011 and $1.0 million upfront license fee received from GSK for the Additional MABAs in
October 2011.
Off-Balance Sheet Arrangements
We lease various real properties under an operating lease that generally requires us to pay taxes, insurance, maintenance, and minimum lease payments. This
lease has options to renew.
We have not entered into any off-balance sheet financial arrangements and have not established any structured finance or special purpose entities. We have
not guaranteed any debts or commitments of other entities or entered into any options on non-financial assets.
Contractual Obligations and Commercial Commitments
In the table below, we set forth our enforceable and legally binding obligations and future commitments, as well as obligations related to all contracts that we
are likely to continue, regardless of the fact that they were cancelable as of December 31, 2011. Some of the figures that we include in this table are based on
management's estimate and assumptions about these obligations, including their duration, the possibility of renewal, anticipated actions by third parties, and other
factors. Because these estimates and assumptions are necessarily subjective, the obligations we will actually pay in future periods may vary from those reflected
in the table.
(in millions)
Convertible subordinated notes(1)
Note payable
Capital lease(2)
Facility operating leases(3)
Purchase obligations(4)
Total
Total
$ 190.6 $
—*
—*
44.3
1.0
$ 235.9 $
Less than
1 year
1 - 3
years
4 - 5
years
After 5
years
5.2 $ 10.4 $ 175.0 $ —
—
—*
—
—*
18.8
5.4
0.8
—
11.4 $ 20.5 $ 185.2 $ 18.8
—
—
9.9
0.2
—
—
10.2
—
(1)
(2)
(3)
(4)
In January 2008, we closed an underwritten public offering of $172.5 million aggregate principal amount of unsecured
convertible subordinated notes that will mature on January 15, 2015. The financing raised proceeds, net of issuance costs, of
$166.7 million which is being used for general corporate purposes. The notes bear interest at the rate of 3.0% per year, that is
payable semi-annually in arrears in cash on January 15 and July 15 of each year, beginning on July 15, 2008. The notes are
convertible, at the option of the holder, into shares of our common stock at an initial conversion rate of 38.6548 shares per $1,000
principal amount of the notes, subject to adjustment in certain circumstances, which represents an initial conversion price of
approximately $25.87 per share.
As security for performance of certain obligations under the capital lease for office equipment, we have issued letters of credit in
the aggregate of approximately $0.1 million, collateralized by an equal amount of restricted cash.
As security for performance of certain obligations under the operating leases for our headquarters, we have issued letters of credit
in the aggregate of approximately $0.8 million, collateralized by an equal amount of restricted cash.
On January 6, 2012, Astellas exercised its right to terminate our collaboration agreement for VIBATIV®. Pursuant to the terms of
the termination agreement, we may purchase
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certain VIBATIV® inventory from Astellas in 2012.The purchase is subject to release of the inventory by a third-party
manufacturer and may cost up to $11.0 million.
*
Amount due is less than $50,000.
We indemnify our officers and directors for certain events or occurrences, subject to certain limits. We may be subject to contingencies that may arise from
matters such as product liability claims, legal proceedings, shareholder suits and tax matters, as such, we are unable to estimate the potential exposure related to
these indemnification agreements. We have not recognized any liabilities relating to these agreements as of December 31, 2011.
Pursuant to our LABA collaboration with GSK, we will be obligated to make milestone payments to GSK which could total as much as $220.0 million if
both a single-agent and a combination product or two different combination products are launched in multiple regions of the world with the current lead LABA,
VI. If global regulatory authorities accept the applications for RELOVAIR™, which we anticipate will be filed by GSK beginning in mid-2012, a portion of these
potential milestone payments could be payable to GSK within the next two years. We have not recognized any liabilities relating to this agreement as of
December 31, 2011.
Recent Accounting Update
In June 2011, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2011-05, "Presentation of Comprehensive
Income" an update to Accounting Standards Codification (ASC) Topic 220, "Comprehensive Income". The amendments of this update require that all nonowner
changes in stockholders' equity be presented either in a single continuous statement of comprehensive income or in two separate but consecutive statements. This
update is to be applied retrospectively and is effective for financial statements issued for fiscal years, and interim periods within those years, beginning after
December 15, 2011, and interim and annual periods thereafter. This update will be effective for us January 1, 2012. We do not expect the adoption of this
guidance to have a material impact on our condensed consolidated financial statements
ITEM 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISK
We are exposed to market risk, including changes to interest rates which are confined to our cash, cash equivalents, restricted cash and marketable securities.
We have invested primarily in money market funds, federal agency notes, corporate debt securities and U.S. treasury notes. To reduce the volatility relating to
these exposures, we have put investment and risk management policies and procedures in place. The securities in our investment portfolio are not leveraged, are
classified as available-for-sale and, due to their very short-term nature, are subject to minimal interest rate risk. We currently do not engage in hedging activities.
Because of the short-term maturities of our investments, we do not believe that an increase in market rates would have any significant negative impact on the
realized value of our investment portfolio. Our outstanding note payable has a fixed interest rate and therefore, we have no exposure to interest rate fluctuations.
Most of our transactions are conducted in U.S. dollars, although we do conduct some preclinical activities and manufacture some active pharmaceutical
ingredients with vendors located outside the United States. Some of these expenses are paid in U.S. dollars, and some are paid in the local foreign currency. If the
exchange rate undergoes a change of 10%, we do not believe that it would have a material impact on our results of operations or cash flows.
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ITEM 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATA
Consolidated Balance Sheets as of December 31, 2011 and December 31, 2010
Consolidated Statements of Operations for each of the three years in the period ended December 31, 2011
Consolidated Statements of Stockholders' Net Capital Deficiency for each of the three years in the period ended
December 31, 2011
Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, 2011
Notes to Consolidated Financial Statements
Supplementary Financial Data (unaudited)
Report of Independent Registered Public Accounting Firm
56
57
58
59
60
61
87
88
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THERAVANCE, INC.
Consolidated Balance Sheets
(in thousands, except per share data)
Assets
Current assets:
Cash and cash equivalents
Marketable securities
Receivable from related party
Notes receivable, current
Prepaid and other current assets
Total current assets
Restricted cash
Property and equipment, net
Notes receivable, non-current
Other assets, non-current
Total assets
Liabilities and stockholders' net capital deficiency
Current liabilities:
Accounts payable
Accrued personnel related expenses
Accrued clinical and development expenses
Accrued interest on convertible subordinated notes
Other accrued liabilities
Note payable and capital lease, current
Deferred revenue, current
Total current liabilities
Convertible subordinated notes
Deferred rent
Note payable and capital lease, non-current
Deferred revenue, non-current
Commitments and contingencies (Notes 3 and 9)
Stockholders' net capital deficiency:
Preferred stock, $0.01 par value, 230 shares authorized, no shares issued and outstanding
Common stock, $0.01 par value; authorized: 200,000 shares; outstanding: 85,543 at
December 31, 2011 and 70,950 at December 31, 2010
Class A common stock, $0.01 par value; authorized: 30,000 shares; outstanding: none at
December 31, 2011 and 9,402 at December 31, 2010
Additional paid-in capital
Accumulated other comprehensive income
Accumulated deficit
Total stockholders' net capital deficiency
Total liabilities and stockholders' net capital deficiency
See accompanying notes to consolidated financial statements.
57
$
$
$
December 31,
2011
2010
44,778 $
196,137
223
100
3,525
244,763
893
10,372
240
2,514
258,782 $
5,813 $
9,643
6,956
2,372
1,946
69
18,697
45,496
172,500
5,821
—
122,017
—
855
163,333
146,301
194
531
5,995
316,354
893
10,215
400
3,340
331,202
2,128
8,617
2,801
2,372
2,008
206
21,922
40,054
172,500
3,574
69
137,425
—
710
—
1,228,037
16
(1,315,960)
(87,052)
258,782 $
$
94
1,177,359
33
(1,200,616)
(22,420)
331,202
Table of Contents
THERAVANCE, INC.
Consolidated Statements of Operations
(in thousands, except per share data)
Revenue (including amounts from a related party of $9,658 in 2011, $9,826 in 2010,
and $15,073 in 2009)
Operating expenses:
Research and development
General and administrative
Restructuring charges
Total operating expenses
Loss from operations
Interest and other income
Interest expense
Net loss
Year Ended December 31,
2010
2011
2009
$
24,512 $
24,223 $
24,374
75,070
27,476
—
102,546
103,568
30,681
—
134,249
(109,737)
77,524
27,066
1,145
105,735
(81,361)
2,111
(6,052)
$ (115,344) $ (83,862) $ (85,302)
(78,323)
505
(6,044)
415
(6,022)
Basic and diluted net loss per share
$
(1.41) $
(1.16) $
(1.35)
Shares used in computing basic and diluted net loss per share
82,051
72,070
63,027
See accompanying notes to consolidated financial statements.
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Balance at December 31, 2008
Exercise of stock options, and
Issuance of common stock in
settlement of restricted stock
units, stock awards and
purchase plan
Stock-based compensation
Comprehensive loss:
Net loss
Net unrealized gain on
marketable securities
Total comprehensive loss
Balance at December 31, 2009
Exercise of stock options, and
Issuance of common stock in
settlement of restricted stock
units, stock awards and
purchase plan
Issuance of common stock for
cash in secondary stock
offering, net of expenses of
$5.7 million
Issuance of common stock in
private placement to a related
party, net of expenses of
$0.2 million
Stock-based compensation
Comprehensive loss:
Net loss
Net unrealized loss on
marketable securities
Total comprehensive loss
Balance at December 31, 2010
Exercise of stock options, and
Issuance of common stock in
settlement of restricted stock
units, stock awards and
purchase plan
Issuance of common stock in
private placements to a related
party
Conversion of Class A common
stock (Note 3)
Stock-based compensation
Comprehensive loss:
Net loss
Net unrealized loss on
marketable securities
Total comprehensive loss
Balance at December 31, 2011
THERAVANCE, INC.
Consolidated Statements of Stockholders' Net Capital Deficiency
(in thousands)
Common Stock
Class A
Common Stock
Shares
Amount
Shares
Amount
Additional
Paid-In
Capital
Accumulated
Other
Comprehensive
Income
52,576
$
525
9,402
$
94
$
895,383
$
501
Accumulated
Deficit
(1,031,452) $
$
Total
Stockholders'
Net Capital
Deficiency
(134,949)
2,254
—
—
—
24
—
—
—
—
—
—
—
54,830
549
9,402
—
—
—
—
94
11,699
20,000
—
—
—
—
—
—
—
11,723
20,000
(85,302)
(85,302)
(466)
—
927,082
35
(1,116,754)
(466)
(85,768)
(188,994)
8,761
93,478
129,190
19,009
(83,862)
(2)
(83,864)
(22,420)
12,195
13,618
—
24,916
(17)
(115,361)
(87,052)
1,745
17
—
—
8,744
8,625
86
—
—
93,392
5,750
—
—
—
58
—
—
—
—
—
—
—
70,950
710
9,402
—
—
—
—
94
129,132
19,009
—
—
1,177,359
2,134
574
9,402
2,483
—
—
21
5
94
25
—
—
—
—
(9,402)
—
—
—
—
12,174
—
(94)
—
—
—
13,613
—
24,891
—
—
—
—
—
—
—
(2)
33
—
—
—
—
—
(17)
—
—
—
—
(83,862)
—
(1,200,616)
—
—
—
—
—
85,543
$
855
—
$
—
$ 1,228,037
$
16
$
(1,315,960) $
See accompanying notes to consolidated financial statements.
59
(115,344)
(115,344)
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THERAVANCE, INC.
Consolidated Statements of Cash Flows
(in thousands)
Cash flows from operating activities
Net loss
Adjustments to reconcile net loss to net cash used in operating activities:
Depreciation and amortization
Stock-based compensation
Loss on sale of equipment
Forgiveness of notes receivable
Changes in operating assets and liabilities:
Receivables
Prepaid and other assets
Accounts payable
Accrued personnel related expenses, accrued interest on convertible
subordinated notes and accrued liabilities
Deferred rent
Deferred revenue
Other long-term liabilities
Net cash used in operating activities
Cash flows from investing activities
Purchases of property and equipment
Purchases of marketable securities
Maturities of marketable securities
Sales of marketable securities
Sale of equipment
Release of restricted cash
Additions to notes receivable
Decrease in notes receivable
Net cash (used in) provided by investing activities
Cash flows from financing activities
Payments on notes payable and capital leases
Net proceeds from issuances of common stock
Net cash provided by financing activities
Net increase (decrease) in cash and cash equivalents
Cash and cash equivalents at beginning of period
Cash and cash equivalents at end of period
Supplemental Disclosure of Cash Flow Information
Cash paid for interest
Supplemental Disclosure of Non-Cash Investing Activity
Acquisition cost of property and equipment under capital lease
Year Ended December 31,
2010
2011
2009
$ (115,344) $
(83,862) $
(85,302)
7,583
24,916
—
16
(29)
2,288
3,312
5,124
2,429
(18,633)
—
(88,338)
6,336
19,009
33
8
81
649
(236)
3,321
1,446
(21,801)
(128)
(75,144)
5,541
20,000
—
(13)
14
2,741
(1,625)
(3,689)
(709)
4,589
389
(58,064)
(3,628)
(301,563)
231,476
17,321
—
—
(140)
715
(55,819)
(861)
(183,899)
131,855
12,024
12
417
—
140
(40,312)
(744)
(123,460)
118,065
5,000
—
2,500
—
375
1,736
(206)
(184)
25,808
25,602
(118,555)
163,333
44,778 $
231,429
231,245
115,789
47,544
163,333 $
(131)
11,723
11,592
(44,736)
92,280
47,544
$
$
5,195 $
5,217 $
5,229
$
— $
— $
154
See accompanying notes to consolidated financial statements.
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
1. Description of Operations and Summary of Significant Accounting Policies
Description of Operations
Theravance, Inc. (the Company or Theravance) is a biopharmaceutical company with a pipeline of internally discovered product candidates and strategic
collaborations with pharmaceutical companies. Theravance is focused on the discovery, development and commercialization of small molecule medicines across
a number of therapeutic areas including respiratory disease, bacterial infections, and central nervous system (CNS)/pain. By leveraging the Company's proprietary
insight of multivalency to drug discovery, Theravance is pursuing a best-in-class strategy designed to discover superior medicines in areas of significant unmet
medical need.
Principles of Consolidation
The consolidated financial statements include the accounts of the Company and its wholly owned subsidiaries. All intercompany balances and transactions
have been eliminated in consolidation.
Use of Management's Estimates
The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the
amounts reported in the consolidated financial statements and accompanying notes. Actual results could differ materially from those estimates.
Segment Reporting
The Company has determined that it operates in a single segment which is the research and development of human therapeutics. Revenues are generated
primarily from the Company's collaborations with GlaxoSmithKline plc (GSK), located in the United Kingdom and, through 2011, Astellas Pharma Inc.
(Astellas), located in Japan. All long-lived assets are maintained in the United States.
Cash and Cash Equivalents
The Company considers all highly liquid investments purchased with a maturity of three months or less on the date of purchase to be cash equivalents. Cash
equivalents are carried at cost, which approximates fair value.
Under certain lease agreements and letters of credit, the Company has pledged cash and cash equivalents as collateral. Restricted cash related to such
agreements was $0.9 million as of December 31, 2011 and December 31, 2010.
Marketable Securities
The Company determines the appropriate classification of its marketable securities, which consist of debt securities, at the time of purchase and reevaluates
such designation at each balance sheet date. All of the marketable securities are classified as available-for-sale and carried at estimated fair values and reported in
either cash equivalents or marketable securities. Unrealized gains and losses on available-for-sale securities are reported in accumulated other comprehensive
income as a separate component of stockholders' net capital deficiency. Interest, amortization of purchase premiums and
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
1. Description of Operations and Summary of Significant Accounting Policies (Continued)
discounts, and realized gains and losses on sales of securities are included in interest and other income. The cost of securities sold is based on the specific
identification method.
The Company regularly reviews all of its investments for other-than-temporary declines in fair value. The Company's review includes the consideration of
the cause of the impairment, including the creditworthiness of the security issuers, the number of securities in an unrealized loss position, the severity and
duration of the unrealized losses, whether the Company has the intent to sell the securities and whether it is more likely than not that the Company will be
required to sell the securities before the recovery of their amortized cost basis. When the Company determines that the decline in fair value of an investment is
below the amortized cost basis and the decline is other-than-temporary, the Company reduces the carrying value of the security and records a loss for the amount
of such decline.
Fair Value of Financial Instruments
Financial instruments include cash equivalents, marketable securities, related party receivables, accounts payable, accrued liabilities and convertible
subordinated notes. Marketable securities are carried at estimated fair value. The carrying value of cash equivalents, receivables from related party, accounts
payable and accrued liabilities approximate their fair value due to the relatively short nature of these instruments. Convertible subordinated notes are described in
Note 7.
Concentration of Credit Risks
The Company invests in a variety of financial instruments and, by its policy, limits the amount of credit exposure with any one issuer, industry or geographic
area for investments other than instruments backed by the U.S. federal government.
Notes Receivable
The Company provided loans to certain employees to assist them primarily with the purchase of a primary residence, which collateralizes the resulting loans.
There was no interest receivable related to the loans as of December 31, 2011 and December 31, 2010. The outstanding loans have maturity dates ranging from
July 2012 through May 2014.
Inventory
Inventory is stated at the lower of cost or market value and is included in prepaid and other current assets in the accompanying consolidated balance sheets.
Inventory is comprised of VIBATIV® active pharmaceutical ingredient. VIBATIV® has a limited shelf life. Astellas purchased VIBATIV® inventory from the
Company at a cost of $1.2 million in 2011 and $2.0 million in 2010. The Company expensed inventory, on an average cost basis, that was no longer realizable of
$0.5 million in 2011, $0.8 million in 2010 and $1.2 million in 2009. Inventory was valued at zero at December 31, 2011 and $1.7 million at December 31, 2010.
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
1. Description of Operations and Summary of Significant Accounting Policies (Continued)
Property and Equipment
Property, equipment and leasehold improvements are stated at cost and depreciated using the straight-line method as follows:
Leasehold improvements
Equipment, furniture and fixtures
Software and computer equipment
Shorter of remaining lease terms or useful life
5 - 7 years
3 years
Capitalized Software
The Company capitalizes certain costs related to direct material and service costs for software obtained for internal use. Capitalized software costs are
depreciated over 3 years.
Impairment of Long-Lived Assets
Long-lived assets include property and equipment. The carrying value of long-lived assets is reviewed for impairment whenever events or changes in
circumstances indicate that the asset may not be recoverable. An impairment loss is recognized when the total of estimated future cash flows expected to result
from the use of the asset and its eventual disposition is less than its carrying amount.
Bonus Accruals
The Company has short-term bonus programs for eligible employees. Bonuses are determined based on various criteria, including the achievement of
corporate, departmental and individual goals. Bonus accruals are estimated based on various factors, including target bonus percentages per level of employee and
probability of achieving the goals upon which bonuses are based. The Company's management periodically reviews the progress made towards the goals under
the bonus programs. As bonus accruals are dependent upon management's judgments of the likelihood of achieving the various goals, it is possible for bonus
expense to vary significantly in future periods if changes occur in those management estimates.
Deferred Rent
Deferred rent consists of the difference between cash payments and the recognition of rent expense on a straight-line basis for the buildings the Company
occupies. Rent expense is being recognized ratably over the life of the leases. Because the Company's facility operating leases provide for rent increases over the
terms of the leases, average annual rent expense during the first 1.5 years of the leases exceeded the Company's actual cash rent payments. Also included in
deferred rent are lease incentives of $2.6 million as of December 31, 2011, which is being recognized ratably over the life of the leases.
Revenue Recognition
The Company recognizes revenue in accordance with Financial Accounting Standards Board (FASB) Subtopic ASC 605-25, "Revenue Recognition—
Multiple-Element Arrangements." As of January 1, 2011, the Company adopted on a prospective basis the accounting updates to guidance ASC 605 "Revenue
Recognition", subtopic ASC 605-25 "Revenue with Multiple Element Arrangements"
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
1. Description of Operations and Summary of Significant Accounting Policies (Continued)
and subtopic ASC 605-28 "Revenue Recognition-Milestone Method", which provides accounting guidance for revenue recognition for arrangements with
multiple deliverables and guidance on defining the milestone and determining when the use of the milestone method of revenue recognition for research and
development transactions is appropriate, respectively. The adoption of ASC 605-25 "Revenue with Multiple Element Arrangements" and the election of the
milestone method under subtopic ASC 605-28 "Revenue Recognition-Milestone Method" did not have a material impact on the Company's consolidated financial
statements. However, these updates will result in different accounting treatment for future new collaboration arrangements and substantive milestones earned after
the dates of adoption.
The Company's revenues are related primarily to its collaboration arrangements with GSK and, through 2011, with Astellas (see Note 3, "Collaboration
Arrangements" for more information). The Company's arrangements provide for various types of payments to the Company, including non-refundable upfront
fees and milestone payments and royalty payments. The Company recognizes revenue when persuasive evidence of an arrangement exists, delivery has occurred
or services have been rendered, the price is fixed or determinable, and collectability is reasonably assured.
For multiple-element arrangements entered into prior to January 1, 2011, the Company determined the deliverables under its collaboration agreements with
GSK and Astellas did not meet the criteria required for separate accounting units for the purposes of revenue recognition. As a result, the Company recognized
revenue from non-refundable, upfront fees and development milestone payments ratably over the term of its performance under the agreements. These upfront or
milestone payments received, pending recognition as revenue, are recorded as deferred revenue and are classified as a short-term or long-term liability on the
balance sheet to be amortized over the period of deferral. The Company periodically reviewed the estimated performance periods of its contracts based on the
progress of its programs.
In accordance with ASC Subtopic 808-10, "Collaborative Arrangement," and pursuant to the Company's agreement with Astellas, the Company recognized
as revenue the net impact of transactions with Astellas related to VIBATIV® inventory including revenue specifically attributable to any sales, and cost of
inventory either transferred or expensed as unrealizable.
The Company recognizes royalty revenue on net sales in the period in which the royalties are earned based on net sales reporting provided by the Company's
former collaboration partner, Astellas.
The Company has been reimbursed by GSK and Astellas for certain external development costs under their respective collaboration agreements. Such
reimbursements have been reflected as a reduction of research and development expense and not as revenue.
For multiple-element arrangements entered into, or materially modified, subsequent to January 1, 2011, each deliverable within a multiple deliverable
revenue arrangement is accounted for as a separate unit of accounting if both of the following criteria are met: (1) the delivered item or items have value to the
customer on a standalone basis and (2) for an arrangement that includes a general right of return relative to the delivered item(s), delivery or performance of the
undelivered item(s) is considered probable and substantially in the Company's control.
In addition, multiple deliverable revenue arrangement consideration is allocated at the inception of an arrangement to all deliverables using the relative
selling price method. The Company also applies a selling price hierarchy for determining the selling price of a deliverable, which includes
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
1. Description of Operations and Summary of Significant Accounting Policies (Continued)
(1) vendor-specific objective evidence, if available, (2) third-party evidence, if vendor-specific objective evidence is not available, and (3) estimated selling price
if neither vendor-specific nor third-party evidence is available.
Where a portion of non-refundable upfront license or other payments, or milestone payments received are allocated to continuing performance obligations
under the terms of a collaborative agreement, it will be recorded as deferred revenue and recognized as revenue ratably over the term of its estimated performance
period under the agreement. The Company determines the estimated performance periods and they are periodically reviewed based on the progress of the related
program. The effect of a change made to an estimated performance period and therefore revenue recognized ratably would occur on a prospective basis in the
period that the change was made.
Deferred revenue associated with a non-refundable payment received under a collaborative agreement that the performance obligations are terminated will
result in an immediate recognition of any remaining deferred revenue in the period that termination occurred provided that all performance obligations have been
satisfied.
For milestones earned after January 1, 2011, the Company recognizes revenue from milestone payments when (i) the milestone event is substantive and its
achievability was not reasonably assured at the inception of the agreement and (ii) the Company does not have ongoing performance obligations related to the
achievement of the milestone earned. Milestone payments are considered substantive if all of the following conditions are met: the milestone payment (a) is
commensurate with either the Company's performance to achieve the milestone or the enhancement of the value of the delivered item or items as a result of a
specific outcome resulting from the Company's performance to achieve the milestone, (b) relates solely to past performance, and (c) is reasonable relative to all of
the deliverables and payment terms (including other potential milestone consideration) within the arrangement. See Note 3, "Collaboration Arrangements," for
analysis of each milestone event deemed to be substantive or non-substantive.
Research and Development Costs
Research and development costs are expensed in the period that services are rendered or goods are received. Research and development costs consist of
salaries and benefits, laboratory supplies and facility costs, as well as fees paid to third parties that conduct certain research and development activities on behalf
of the Company, net of certain external research costs reimbursed by GSK and, through 2011, Astellas.
Preclinical Study and Clinical Study Expenses
Most of the Company's preclinical studies and all of its clinical studies have been performed by third-party contract research organizations (CROs). Some
CROs bill monthly for services performed, while others bill based upon milestones achieved. The Company reviews the activities performed under the significant
contracts each quarter. For preclinical studies, the significant factors used in estimating accruals include the percentage of work completed to date and contract
milestones achieved. For clinical study expenses, the significant factors used in estimating accruals include the number of patients enrolled and percentage of
work completed to date. Vendor confirmations are obtained for contracts with longer duration when necessary to validate the Company's estimate of expenses.
The Company's estimates are highly dependent upon the timeliness and accuracy of the data provided by its CROs
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
1. Description of Operations and Summary of Significant Accounting Policies (Continued)
regarding the status of each program and total program spending and adjustments are made when deemed necessary.
Fair Value of Stock-Based Compensation Awards
Stock-based compensation arrangements currently include the following awards granted under the 2004 Equity Incentive Plan (2004 Plan) and the 2008 New
Employee Equity Incentive Plan (2008 Plan): stock options, restricted stock unit awards (RSUs), performance-contingent RSUs, restricted stock awards (RSAs),
and performance-contingent RSAs. In addition, purchases of common stock by the Company's employees at a discount to the market price during offering periods
under the Company's Employee Stock Purchase Plan (ESPP). Under the 2004 Plan and 2008 Plan, stock options may be granted with an exercise price not less
than 100% of the fair market value of the common stock on the date of grant. Stock options are generally granted with terms of up to ten years and vest over a
period of four years.
The Company uses the Black-Scholes option pricing model to estimate the fair value of options granted under its equity incentive plans and rights to acquire
stock granted under its employee stock purchase plan. The Black-Scholes option valuation model requires the use of assumptions, including the expected term of
the award and the expected stock price volatility. The Company used the "simplified" method as described in Staff Accounting Bulletin No. 107 for the expected
option term because the usage of its historical exercise data is limited due to post-IPO exercise restrictions. Beginning April 1, 2011, the Company used its
historical volatility to estimate expected stock price volatility. Prior to April 1, 2011, the Company used peer company price volatility to estimate expected stock
price volatility due to the Company's limited historical common stock price volatility since its initial public offering in 2004. RSUs and RSAs are measured based
on the fair market values of the underlying stock on the dates of grant.
Stock-based compensation expense was calculated based on awards ultimately expected to vest and has been reduced for estimated forfeitures at the time of
grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. The Company's estimated annual forfeiture rates for stock
options, RSUs and RSAs are based on its historical forfeiture experience.
The estimated fair value of stock options, RSUs and RSAs is expensed on a straight-line basis over the expected term of the grant and the fair value of
performance-contingent RSUs and RSAs is expensed during the term of the award when the Company determines that it is probable that certain performance
milestones will be achieved. Compensation expense for purchases under the ESPP is recognized based on the estimated fair value of the common stock during
each offering period and purchase discount percentage.
The Company has not recognized, and does not expect to recognize in the near future, any tax benefit related to employee stock-based compensation costs as
a result of the full valuation allowance on the Company's net deferred tax assets including deferred tax assets related to its net operating loss carryforwards.
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NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
1. Description of Operations and Summary of Significant Accounting Policies (Continued)
Income Taxes
The Company utilizes the asset and liability method of accounting for income taxes. Under this method, deferred tax assets and liabilities are determined
based on differences between financial reporting and tax basis of assets and liabilities and are measured using enacted tax rates and laws that will be in effect
when the differences are expected to reverse. A valuation allowance is provided when it is more likely than not that some portion or all of a deferred tax asset will
not be realized.
Comprehensive Loss
Comprehensive loss is comprised of net loss and other comprehensive income (loss). Other comprehensive income (loss) consists of changes in unrealized
gains and losses on the Company's available-for-sale securities. Comprehensive income or loss for the years ended December 31, 2011, 2010 and 2009 has been
presented in the Company's Consolidated Statements of Stockholders' Net Capital Deficiency.
Related Parties
Transactions with GSK are described in Note 3, "Collaboration Arrangements".
Robert V. Gunderson, Jr. is a director of the Company. The Company has engaged Gunderson Dettmer Stough Villeneuve Franklin & Hachigian, LLP, of
which Mr. Gunderson is a partner, as its primary legal counsel. Fees are incurred in the ordinary course of business were $0.3 million in 2011, $0.7 million in
2010, and $0.4 million in 2009.
Recent Accounting Update
In June 2011, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2011-05, "Presentation of Comprehensive
Income" an update to Accounting Standards Codification (ASC) Topic 220, "Comprehensive Income". This update requires that all nonowner changes in
stockholders' equity be presented either in a single continuous statement of comprehensive income or in two separate but consecutive statements. This update is to
be applied retrospectively and is effective for financial statements issued for fiscal years, and interim periods within those years, beginning after December 15,
2011, and interim and annual periods thereafter. This update will be effective for the Company January 1, 2012. The Company does not expect the adoption of
this guidance to have a material impact on its consolidated financial statements.
2. Net Loss per Share
Basic net loss per share (basic EPS) is computed by dividing net loss by the weighted-average number of common shares outstanding during the period, less
RSAs subject to forfeiture. Diluted net loss per share (diluted EPS) is computed by dividing net loss by the weighted-average number of common shares
outstanding during the period, less RSAs subject to forfeiture, plus dilutive potential common shares. Diluted EPS is identical to basic EPS for all periods
presented since potential common shares are excluded from the calculation, as their effect is anti-dilutive.
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2. Net Loss per Share (Continued)
Weighted-Average Shares Outstanding
THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
The following table sets forth the computation of basic and diluted net loss and the weighted-average number of shares used in computing basic and diluted
net loss per share:
Basic and diluted:
Net loss
Weighted-average shares of common stock outstanding
Less: unvested RSAs
Weighted-average shares used in computing basic and diluted net loss
2011
Year Ended December 31,
2010
(in thousands, except
for per share data)
2009
$ (115,344) $ (83,862) $ (85,302)
84,493
(2,442)
72,103
(33)
63,084
(57)
per common share
82,051
72,070
63,027
Basic and diluted net loss per common share
$
(1.41) $
(1.16) $
(1.35)
Anti-dilutive securities
Securities that were not included in the computation of diluted EPS because their effect would have been anti-dilutive were as follows:
(in thousands)
Shares issuable upon the exercise of stock options
Shares issuable under RSUs and RSAs
Shares issuable upon the conversion of convertible debt
Total anti-dilutive securities
3. Collaboration Arrangements
GSK
LABA collaboration with GSK
Year Ended December 31,
2010
5,823
813
6,668
13,304
2011
4,610
854
6,668
12,132
2009
6,646
444
6,668
13,758
In November 2002, the Company entered into its long-acting beta2 agonist (LABA) collaboration with GSK to develop and commercialize once-daily
LABA products for the treatment of chronic obstructive pulmonary disease (COPD) and asthma. For the treatment of COPD, the collaboration is developing
combination products, RELOVAIR™ and the LAMA/LABA (GSK573719/vilanterol or '719/VI). For the treatment of asthma, the collaboration is developing
RELOVAIR™. RELOVAIR™ is an investigational once-daily combination medicine consisting of a LABA, VI, previously referred to as GW642444 or '444, and
an inhaled corticosteroid (ICS), fluticasone furoate (FF). The LAMA/LABA, '719/VI, is an investigational once-daily combination medicine consisting of the
long-acting muscarinic antagonist (LAMA) '719, and the LABA, VI.
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
3. Collaboration Arrangements (Continued)
The current lead product candidates in the LABA collaboration, VI and FF, were discovered by GSK. In the event that VI is successfully developed and
commercialized, the Company will be obligated to make milestone payments to GSK which could total as much as $220.0 million if both a single-agent and a
combination product or two different combination products are launched in multiple regions of the world. If global regulatory authorities accept the applications
for RELOVAIR™, which the Company anticipates will be filed by GSK beginning in mid-2012, a portion of these potential milestone payments could be payable
to GSK within the next two years. The Company is entitled to annual royalties from GSK of 15% on the first $3.0 billion of annual global net sales and 5% for all
annual global net sales above $3.0 billion. Sales of single-agent LABA medicines and combination medicines would be combined for the purposes of this royalty
calculation. For other products combined with a LABA from the LABA collaboration, such as '719/VI, royalties are upward tiering and range from the mid-single
digits to 10%. However, if GSK is not selling a LABA/ICS combination product at the time that the first other LABA combination is launched, then the royalties
described above for the LABA/ICS combination medicine would be applicable.
In connection with the LABA collaboration, in 2002, Glaxo Group Limited, an affiliate of GSK, purchased shares of the Company's Series E preferred stock
for an aggregate purchase price of $40.0 million.
2004 Strategic Alliance with GSK
In March 2004, the Company entered into its strategic alliance with GSK. Under this alliance, GSK received an option to license exclusive development and
commercialization rights to product candidates from certain of the Company's discovery programs on pre-determined terms and on an exclusive, worldwide basis.
Upon GSK's decision to license a program, GSK is responsible for funding all future development, manufacturing and commercialization activities for
product candidates in that program. In addition, GSK is obligated to use diligent efforts to develop and commercialize product candidates from any program that
it licenses. If the program is successfully advanced through development by GSK, the Company is entitled to receive clinical, regulatory and commercial
milestone payments and royalties on any sales of medicines developed from the program. If GSK chooses not to license a program, the Company retains all rights
to the program and may continue the program alone or with a third party.
In 2005, GSK licensed the Company's bifunctional muscarinic antagonist-beta2 agonist (MABA) program for the treatment of COPD, and in October 2011,
the Company and GSK expanded the MABA program by adding six additional Theravance-discovered preclinical MABA compounds (the "Additional
MABAs"). GSK's development, commercialization, milestone and royalty obligations under the strategic alliance remain the same with respect to '081, the lead
compound in the MABA program. GSK is obligated to use diligent efforts to develop and commercialize at least one MABA within the MABA program, but may
terminate progression of any or all Additional MABAs at any time and return them to the Company, at which point the Company may develop and commercialize
such Additional MABAs alone or with a third party. Both GSK and the Company have agreed not to conduct any MABA clinical studies outside of the strategic
alliance so long as GSK is in possession of the Additional MABAs. If a single-agent MABA medicine containing '081 is successfully developed and
commercialized, the Company is entitled to receive royalties from GSK of between 10% and 20% of annual global net sales up to $3.5 billion, and 7.5% for all
annual global net sales above $3.5 billion. If
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
3. Collaboration Arrangements (Continued)
a MABA medicine containing '081 is commercialized only as a combination product, such as a MABA/ICS, the royalty rate is 70% of the rate applicable to sales
of the single-agent MABA medicine. For single-agent MABA medicines containing an Additional MABA, the Company is entitled to receive royalties from GSK
of between 10% and 15% of annual global net sales up to $3.5 billion, and 10% for all annual global net sales above $3.5 billion. For combination products
containing an Additional MABA, such as a MABA/ICS, the royalty rate is 50% of the rate applicable to sales of the single-agent MABA medicine. If a MABA
medicine containing '081 is successfully developed and commercialized in multiple regions of the world, the Company could earn total milestone payments up to
$125.0 million for a single-agent medicine and up to $250.0 million for both a single-agent and a combination medicine. If a MABA medicine containing an
Additional MABA is successfully developed and commercialized in multiple regions of the world, the Company could earn total milestone payments up to
$129.0 million.
In May 2004, GlaxoSmithKline LLC, an affiliate of GSK, purchased 6,387,096 shares of the Company's Class A common stock for an aggregate purchase
price of $108.9 million and, upon the closing of the Company's initial public offering on October 8, 2004, GlaxoSmithKline LLC purchased an additional 433,757
shares of Class A common stock for an aggregate purchase price of $6.9 million. In November 2010 Glaxo Group Limited, an affiliate of GSK, purchased
5,750,000 shares of the Company's Common Stock for an aggregate purchase price of $129.4 million.
GSK Conversion of the Company's Class A Common Stock and Purchases of Common Stock under the Company's Governance Agreement with GSK
In July 2011, GSK converted all of the shares of the Company's Class A common stock held by its affiliates into 9,401,499 shares of the Company's common
stock on a one share-for-one share basis in accordance with the terms of the Company's restated certificate of incorporation. In addition, Glaxo Group Limited
purchased shares of the Company's common stock pursuant to its periodic "top-up" rights under the Company's governance agreement with GSK dated June 4,
2004, as amended, as follows:
Purchase dates
February 24, 2011
May 3, 2011
August 2, 2011
November 1, 2011
Through December 31, 2011
Common Stock
Shares Purchased
Aggregate Amounts
(in thousands)
152,278 $
261,299 $
102,466 $
58,411 $
3,609
6,689
2,020
1,298
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
3. Collaboration Arrangements (Continued)
GSK Upfront License Fees, Milestone Payments and Revenue
Upfront license fees and milestone payments received from GSK under the LABA collaboration and strategic alliance agreements were as follows:
(in thousands)
GSK Collaborations
LABA/RELOVAIR™ collaboration(1)
Strategic alliance agreement
Strategic alliance—LAMA license(2)
Strategic alliance—MABA program license
Total
(1)
(2)
Through December 31, 2011
Milestone
Payments
Upfront
License Fees
Total
$
$
60,000
10,000 $ 50,000 $
20,000
—
20,000
8,000
3,000
5,000
6,000
22,000
16,000
41,000 $ 69,000 $ 110,000
The Company does not currently expect to be eligible for any additional milestones under this collaboration.
In August 2004, GSK exercised its right to license the Company's LAMA program pursuant to the terms of the strategic alliance.
In 2009, GSK returned the program to the Company.
In August 2011, the Company received a $3.0 million milestone payment from GSK for the initiation of the Phase 1 combination study in the Company's
MABA program.
In October 2011, the Company received an upfront license payment of $1.0 million from GSK related to the Additional MABAs, which is being accounted
for as a new arrangement under the updated multiple element arrangement accounting guidance. The Company allocated revenue from this upfront license
payment and will allocate any potential contingent payments related to the Additional MABAs under the MABA program, as discussed above in the section
entitled Note 1, "Description of Operations and Summary of Significant Accounting Policies—Revenue Recognition," to each non-contingent element based
upon the relative selling price of each element. The Company determined the license has standalone value because the license can be used for its intended purpose
and may be developed, commercialized and manufactured for its intended purpose without any remaining participation from the Company's. As a result, the
Company recognized $936,000 of the upfront license payment and the remaining amount was deferred and will be amortized over the estimated development
period over which we will be performing services.
The eligible potential contingent payments related to the MABA program, which includes the Additional MABAs, are not deemed substantive due to the fact
that the achievement of the event underlying the payment predominantly relates to GSK's performance of future development, manufacturing and
commercialization activities for product candidates after licensing the program.
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
3. Collaboration Arrangements (Continued)
Revenue recognized from GSK under the LABA collaboration and strategic alliance agreements was as follows:
(in thousands)
LABA/RELOVAIR™ collaboration(1)
Strategic alliance agreement
Strategic alliance—LAMA license
Strategic alliance—MABA program license(2)
Total revenue
Year Ended December 31,
2010
2009
2011
$ 4,718 $ 5,081 $
5,081
2,738
4,240
3,014
$ 9,658 $ 9,826 $ 15,073
2,738
—
2,007
1,858
—
3,082
(1)
(2)
In the fourth quarter of 2011, the Company revised the estimated performance period for the LABA program based on its
progress. The Company does not expect that the revisions will have a material impact on future revenue recognized under this
program.
In the fourth quarter of 2011 and the first quarter of 2010, the Company revised the estimated performance period for the MABA
program based on its progress. The Company does not expect that the revisions will have a material impact on future revenue
recognized under this program.
Astellas
In November 2005, the Company entered into a global collaboration arrangement with Astellas for the development and commercialization of VIBATIV®.
On January 6, 2012, Astellas exercised its right to terminate this agreement. The rights granted to Astellas ceased upon termination of the agreement and Astellas
has stopped promotional sales efforts. Pursuant to the terms of the agreement, there are no termination payments required by either party and Astellas is entitled to
a ten-year, 2% royalty on future net sales of VIBATIV®. To support the transition, Astellas will sell inventory to the Company, manage certain clinical and
regulatory activities and respond to medical inquiries with respect to VIBATIV® until no later than March 31, 2012. The Company is evaluating global
commercialization alternatives for VIBATIV® either alone or with partners.
Through December 31, 2011, the Company received $191.0 million in upfront license, milestone and other fees from Astellas. The Company recorded these
payments as deferred revenue and is amortizing them ratably over its estimated performance period (development and commercialization period). As a result of
the termination of the VIBATIV® collaboration agreement, the Company is no longer eligible to receive any further milestone payments.
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
3. Collaboration Arrangements (Continued)
Net revenue recognized under this collaboration agreement was as follows:
(in thousands)
Amortization of deferred revenue
Royalties from net sales of VIBATIV®
Proceeds from VIBATIV® delivered to Astellas
Cost of VIBATIV® delivered to Astellas
Cost of unrealizable VIBATIV® inventory
Total net revenue
2011
2009
December 31,
2010
$ 12,975 $ 12,975 $ 11,338
766
—
(1,629)
(1,175)
9,300
1,123
2,058
(938)
(821)
$ 14,854 $ 14,397 $
2,422
1,171
(1,177)
(537)
4. Marketable Securities
The following table is a summary of available-for-sale debt securities and money market funds recorded in cash equivalents or marketable securities in the
Company's Consolidated Balance Sheets. Estimated fair values of available-for-sale securities are generally based on prices obtained from commercial pricing
services:
(in thousands)
U.S. government
securities
U.S. government
agencies
U.S. corporate
notes
U.S. commercial
paper
Money market
funds
Total
Less amounts
classified as
cash equivalents
Less amounts
classified as
restricted cash
Amounts classified
as marketable
securities
Amortized
Cost
December 31, 2011
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Estimated
Fair Value
Amortized
Cost
December 31, 2010
Gross
Unrealized
Gains
Gross
Unrealized
Losses
Estimated
Fair Value
$
66,150 $
24 $
— $
66,174 $
25,966 $
10 $
— $
25,976
93,183
2,707
34,973
38,721
235,734
9
—
3
—
36
(17)
93,175
54,625
(2)
2,705
34,695
—
34,976
97,221
38,721
—
(19) 235,751
91,805
304,312
30
9
—
—
49
(7)
54,648
(9)
34,695
—
97,221
—
(16)
91,805
304,345
(38,721)
—
—
(38,721)
(157,151)
—
—
(157,151)
(893)
—
—
(893)
(893)
—
—
(893)
$ 196,120 $
36 $
(19) $ 196,137 $
146,268 $
49 $
(16) $
146,301
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
4. Marketable Securities (Continued)
The following table provides the net realized gains (losses) on marketable securities for the periods presented:
(in thousands)
Realized gains
Realized losses
Net realized gains (losses)
2011
$ — $
Year Ended
December 31,
2010
2009
(2) —
(2) $
3 $ —
—
3 $ —
$
The Company realized no gains or losses in 2011 and 2010 that were previously classified as unrealized gains and losses in accumulated other
comprehensive income at December 31, 2010 and 2009, respectively.
The following table provides the breakdown of the marketable securities with unrealized losses at December 31, 2011:
(in thousands)
U.S. government agencies
U.S. corporate notes
Total
In loss position for
less than 12 months
In loss position for
more than 12 months
Estimated
Gross
Unrealized
Losses
Fair Value
Estimated
Gross
Unrealized
Losses
Fair Value
Total
Estimated
Gross
Unrealized
Losses
(17) $
(2)
(19) $
— $
—
— $
— $
—
— $
47,807 $
2,754
50,561 $
(17)
(2)
(19)
Fair Value
$
47,807 $
2,754
50,561 $
$
At December 31, 2011, all of the available-for-sale debt securities had contractual maturities within twelve months and the average duration of marketable
securities was approximately five months. The Company does not intend to sell the investments which are in an unrealized loss position and it is unlikely that the
Company will be required to sell the investments before recovery of their amortized cost basis, which may be maturity. The Company has determined that the
gross unrealized losses on its marketable securities at December 31, 2011 were temporary in nature.
5. Fair Value Measurements
The Company defines fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most
advantageous market for the asset or liability in an orderly transaction between market participants on the measurement date.
The Company's valuation techniques are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent
sources, while unobservable inputs reflect the Company's market assumptions. The Company classifies these inputs into the following hierarchy:
Level 1 Inputs— Quoted prices for identical instruments in active markets.
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
5. Fair Value Measurements (Continued)
Level 2 Inputs— Quoted prices for similar instruments in active markets; quoted prices for identical or similar instruments in markets that are not
active; and model-derived valuations whose inputs are observable or whose significant value drivers are observable.
Level 3 Inputs— Unobservable inputs and little, if any, market activity for the assets.
The estimated fair values of the Company's financial assets were as follows:
December 31, 2011
(in thousands)
U.S. government securities
U.S. government agency securities
U.S. corporate notes
U.S. commercial paper
Money market funds
Total
December 31, 2010
(in thousands)
U.S. government securities
U.S. government agency securities
U.S. corporate notes
U.S. commercial paper
Money market funds
Total
Fair Value Measurements at Reporting Date Using
Quoted Prices
in Active
Markets for
Identical
Assets
Significant
Other
Observable
Inputs
Significant
Unobservable
Inputs
Level 1
Level 2
Level 3
$
$
66,174 $
55,901
2,705
—
38,721
163,501 $
— $
37,274
—
34,976
—
72,250 $
Total
66,174
— $
93,175
—
2,705
—
34,976
—
—
38,721
— $ 235,751
Fair Value Measurements at Reporting Date Using
Quoted Prices
in Active
Markets for
Identical
Assets
Significant
Other
Observable
Inputs
Significant
Unobservable
Inputs
Level 1
Level 2
Level 3
$
25,976 $
24,375
34,695
—
91,805
— $
30,273
—
97,221
—
$
176,851 $ 127,494 $
Total
25,976
— $
54,648
—
34,695
—
97,221
—
—
91,805
— $ 304,345
75
Table of Contents
THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
6. Property and Equipment
Property and equipment consists of the following:
(in thousands)
Computer equipment
Software
Furniture and fixtures
Laboratory equipment
Leasehold improvements
Less accumulated depreciation and amortization
Property and equipment, net
December 31,
2011
3,158 $
4,628
3,821
28,894
17,263
57,764
(47,392)
10,372 $
2010
2,473
4,592
3,689
27,006
16,101
53,861
(43,646)
10,215
$
$
Depreciation expense was $3.8 million in 2011, $3.9 million in 2010 and $4.3 million in 2009. The change in accumulated depreciation is net of asset
retirements.
7. Long-Term Obligations
Long-term obligations are as follows:
(in thousands)
Convertible subordinated notes
Note payable to lessor
Convertible Subordinated Notes
December 31, 2011
December 31, 2010
Carrying
value
Estimated
fair value
Carrying
value
Estimated
fair value
$ 172,500 $ 189,588 $ 172,500 $ 202,391
42
—
42
—
In January 2008, the Company closed an underwritten public offering of $172.5 million aggregate principal amount of unsecured convertible subordinated
notes which will mature on January 15, 2015. The financing raised proceeds, net of issuance costs, of $166.7 million. The notes bear interest at the rate of 3.0%
per year, that is payable semi-annually in arrears in cash on January 15 and July 15 of each year, beginning on July 15, 2008. The fair value of debt was estimated
based on the quoted price of the instrument on December 30, 2011.
The notes are convertible, at the option of the holder, into shares of the Company's common stock at an initial conversion rate of 38.6548 shares per $1,000
principal amount of the notes, subject to adjustment in certain circumstances, which represents an initial conversion price of approximately $25.87 per share. The
debt issuance costs, which are included in other long-term assets, are being amortized on a straight-line basis over the life of the notes. Unamortized debt issuance
costs totaled $2.5 million as of December 31, 2011. Amortization expense was $0.8 million in 2011, 2010 and 2009.
Holders of the notes will be able to require the Company to repurchase some or all of their notes upon the occurrence of a fundamental change (as defined) at
100% of the principal amount of the notes being repurchased plus accrued and unpaid interest. The Company may not redeem the notes prior to January 15, 2012.
On or after January 15, 2012 and prior to the maturity date, the Company,
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7. Long-Term Obligations (Continued)
THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
upon notice of redemption, may redeem for cash all or part of the notes if the last reported sale price of its common stock has been greater than or equal to 130%
of the conversion price then in effect for at least 20 trading days during any 30 consecutive trading day period prior to the date on which it provides notice of
redemption. The redemption price will equal 100% of the principal amount of the notes to be redeemed, plus accrued and unpaid interest up to but excluding the
redemption date.
Note Payable
In connection with the Company's original lease agreement for its facility in South San Francisco, California (see Note 8, "Operating Leases and Subleases,"
for more information), the Company received approximately $0.9 million in July 2002 under a tenant improvement loan from the lessor, which is payable in
monthly installments through 2012, bears interest at 14.5% per annum and is secured by the underlying leasehold improvements. The aggregate maturity of the
note payable for the remaining year was $42,000 in 2012 and is included in note payable and capital lease, current in the accompanying consolidated balance
sheets.
Capital Lease
The Company's capital lease agreement for communications equipment entered into in June 2009 is accounted for as follows:
(in thousands)
Obligation of lease arrangement
Minimum lease payments less interest
Present value of future payments
Less current portion
Long-term portion
Year Ended
December 31,
2010
2011
$
79 $ 130
(51)
(52)
79
27
(52)
(27)
27
$ — $
The equipment under the capital lease arrangement is included in property and equipment and the related amortization is included in depreciation and
amortization expense in the consolidated statements of cash flows. The cost of equipment financed under capital leases was $0.2 million and the related
accumulated amortization was $72,000 as of December 31, 2011 and $41,000 as of December 31, 2010.
8. Operating Leases and Subleases
The Company entered into amendments to its South San Francisco, CA facility leases in June 2010. These amendments extend the lease terms through May
2020 and the Company may extend the terms for two additional five-year periods. The leases are for two buildings of approximately 110,000 and 40,000 square
feet.
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Table of Contents
THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
8. Operating Leases and Subleases (Continued)
The Company leases its South San Francisco, California, facilities under a non-cancelable operating lease. Future minimum lease payments under this lease,
exclusive of executory costs, at December 31, 2011, were as follows:
(in thousands)
Years ending December 31:
2012
2013
2014
2015
2016
Thereafter
Total
Expenses and income associated with operating leases were as follows:
(in thousands)
Rent expense
Sublease income, net
$
5,429
5,029
4,859
5,005
5,156
18,806
$ 44,284
2011
Year Ended December 31,
2010
$ 6,702 $ 6,779 $ 6,559
(580)
(637)
(622)
2009
As of December 31, 2011, the Company expects to receive up to $0.2 million of minimum rentals through the end of a non-cancelable sublease in March
2012.
9. Commitments and Contingencies
Guarantees and Indemnifications
The Company indemnifies its officers and directors for certain events or occurrences, subject to certain limits. The Company believes the fair value of these
indemnification agreements is minimal. Accordingly, the Company has not recognized any liabilities relating to these agreements as of December 31, 2011.
Purchase Obligations
As of December 31, 2011, the Company had outstanding purchase obligations on commercially reasonable terms, primarily for services under contract
research, development and clinical supply agreements totaling $1.0 million.
10. Stock-Based Compensation
Equity Incentive Plans
The Company authorized 500,000 shares of common stock for issuance under the 2008 Plan upon its adoption in 2008 and authorized an additional 200,000
shares for issuance under the 2008 Plan in July 2009. The 2008 Plan provided for the granting of non-qualified stock options, restricted stock awards and RSUs to
newly hired employees. Following the approval by stockholders of the amendment
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. Stock-Based Compensation (Continued)
and restatement of the 2004 Plan on April 27, 2010, no additional awards have been made or will be made in the future under the 2008 Plan.
The 2004 Plan provides for the granting of stock options, restricted stock awards, stock appreciation rights and RSUs to employees, officers, directors and
consultants of the Company. On April 27, 2010, an amendment and restatement of the 2004 Plan was approved by the Company's stockholders to, among other
things, reserve additional shares of common stock for issuance thereunder. As of December 31, 2011, total shares remaining available for issuance under the 2004
Plan were 2,090,098.
Employee Stock Purchase Plan
Under the 2004 Employee Stock Purchase Plan (ESPP), the Company's non-officer employees may purchase common stock through payroll deductions at a
price equal to 85 percent of the lower of the fair market value of the stock at the beginning of the offering period or at the end of each applicable purchase period.
The ESPP provides for consecutive and overlapping offering periods of 24 months in duration, with each offering period composed of four consecutive six-month
purchase periods. The purchase periods end on either May 15th or November 15th. ESPP contributions are limited to a maximum of 15 percent of an employee's
eligible compensation.
The Company's ESPP plan also includes a feature that provides for a new offering period to begin when the fair market value of the Company's common
stock on any purchase date during an offering period falls below the fair market value of the Company's common stock on the first day of such offering period.
This feature is called a reset. The Company had resets for new twenty-four month offering periods starting on November 16, 2007, May 16, 2008, November 16,
2008, May 16, 2010, and November 16, 2011. The Company applied modification accounting to determine the incremental fair value associated with the ESPP
resets and recognized the related incremental stock-based compensation expense.
As of December 31, 2011, a total of 2,025,000 shares of common stock were approved and authorized for issuance under the ESPP. Through December 31,
2011, the Company issued 1,468,454 shares under the ESPP at an average price of $10.15 per share. As of December 31, 2011, total shares remaining available
for issuance under the ESPP were 556,546.
Restricted Stock Awards
The Compensation Committee of the Company's Board of Directors approved the grant of 1,168,000 in 2011 and 71,000 shares in 2007, of restricted stock to
certain members of the Company's management. These restricted shares of common stock vest based on continued service, with pre-determined vesting
percentages and anniversary dates. The Company valued the awards based on the closing market price of the Company's common stock on the date of the
respective awards.
Performance-Contingent Restricted Stock Awards
In 2011, the Compensation Committee of the Company's Board of Directors approved the grant of 1,290,000 performance-contingent RSAs to senior
management. These grants have dual triggers of vesting based upon the achievement of certain performance conditions over a six-year timeframe from 2011-2016
and continued employment, both of which must be satisfied in order for the RSAs to vest.
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Table of Contents
THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. Stock-Based Compensation (Continued)
Expense associated with these RSAs would be recognized, if at all, during these years depending on the probability of meeting the performance conditions. The
maximum potential expense associated with the RSAs could be up to approximately $31.9 million (allocated as $6.3 million for research and development
expense and $25.6 million for general and administrative expense) if all of the performance conditions are achieved on time. As of December 31, 2011, the
Company had determined that the achievement of the requisite performance conditions was not probable and, as a result, no compensation expense has been
recognized. As the RSAs are dependent upon the achievement of certain performance conditions, the expense associated with the RSAs may vary significantly
from period to period.
In 2011, the Compensation Committee of the Company's Board of Directors approved the grant of 25,000 performance-contingent RSAs to a non-executive
officer that has dual triggers of vesting based upon the achievement of a performance condition over a timeframe from 2012-2013 and continued employment
through 2014, both of which must be satisfied in order for the award to vest in full. The maximum potential expense associated with this award is approximately
$475,000, which would be recognized in increments based on the achievement of the performance condition. As of December 31, 2011, the Company had
determined that the achievement of the requisite performance condition was not probable and, as a result, no compensation expense has been recognized. As the
vesting of the RSAs is contingent upon the achievement of the performance condition, the expense associated with the RSAs may vary significantly from period
to period.
Performance-Contingent Restricted Stock Units
In 2010, the Compensation Committee of the Company's Board of Directors approved the grant of 210,000 performance-contingent RSUs to senior
management. These awards have dual triggers of vesting based upon the successful achievement of certain corporate operating milestones during 2010 and 2011,
as well as a requirement for continued employment through early 2014. As of February 11, 2011, both performance milestones had been deemed achieved, and
time-based vesting commenced with respect to all of the performance-contingent RSU shares.
Director Compensation Program
Non-employee directors of the Company receive compensation for services provided as a director. Each member of the Company's Board who is not an
employee receives an annual retainer as well as a fee for each board and committee meeting attended. Commencing on April 27, 2011, chairpersons of the various
committees of the Board, the Audit Committee, the Compensation Committee, Nominating/Corporate Governance Committee and the Science and Technology
Advisory Committee receives a fixed retainer. The lead independent director also receives a fixed retainer.
Each of the Company's independent directors receives periodic automatic grants of equity awards under a program implemented under the 2004 Plan. These
grants are non-discretionary. Only independent directors of the Company or affiliates of such directors are eligible to receive automatic grants under the 2004
Plan. Under the program, as amended in July 2010, each individual who first becomes an independent director will, on the date such individual joins the Board,
automatically be granted (i) a one-time grant of RSUs covering 6,000 shares of the Company's common stock and (ii) a one-time nonstatutory stock option grant
covering 6,000 shares of the Company's common stock.
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. Stock-Based Compensation (Continued)
These initial equity grants vest monthly over the director's first two years of service. In addition, on the date of joining the Board, the new director will also
receive the standard annual equity awards (if joining on the date of the Company's Annual Meeting of Stockholders) or pro-rated annual equity awards (if joining
on any other date). The pro-ration is based upon the number of months of service the new board member will provide during the 12-month period ending on the
one-year anniversary of the most recent annual meeting of stockholders. Annually, upon his or her re-election to the Board at the Annual Meeting of
Stockholders, each independent director is automatically granted both an RSU covering 6,000 shares of the Company's common stock and a nonstatutory stock
option covering 6,000 shares of the Company's common stock. These standard annual equity awards vest monthly over the twelve month period of service
following the date of grant. In addition, all automatic equity awards vest in full if the Company is subject to a change in control or the Board member dies while
in service.
Stock-Based Compensation Expense
The allocation of stock-based compensation expense included in the consolidated statements of operations was as follows:
(in thousands)
Research and development
General and administrative
Total stock-based compensation expense
2011
Year Ended December 31,
2010
$ 13,422 $ 10,322 $ 11,542
8,458
$ 24,916 $ 19,009 $ 20,000
11,494
8,687
2009
Stock-based compensation expense included in the consolidated statements of operations by award type was as follows:
(in thousands)
Employee stock options
Employee RSUs
Employee RSAs
Non-employee options and RSUs
ESPP
Total stock-based compensation expense
Year Ended December 31,
2010
2009
2011
4,528 $
$
7,003 $ 10,271
7,473
9,783
470
398
501
1,186
1,285
639
$ 24,916 $ 19,009 $ 20,000
13,290
5,498
307
1,293
In connection with the retirement of the Company's former chairman of the Board of Directors in April 2010, the Company entered into a consulting
agreement that provided for, among other things, the acceleration of an RSU that was scheduled to vest through April 2012 and an extension of the period of time
in which vested stock options may be exercised until to the stated expiration date of the stock options. As a result of the stock option modification, the Company
recorded an expense of $0.9 million in June 2010.
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. Stock-Based Compensation (Continued)
As of December 31, 2011, the unrecognized compensation cost, net of expected forfeitures, and the estimated weighted-average amortization period, using
the straight-line attribution method, was as follows:
(in thousands, except amortization period)
Stock options
RSUs
RSAs
Compensation Awards
Unrecognized
Compensation Cost
Weighted-average
amortization period
(years)
$
$
$
7,293
12,449
5,389
2.8
2.0
4.5
The following table summarizes equity award activity under the 2008 Plan and the 2004 Plan, and related information:
Number of
Shares
Subject to
Outstanding
Options
Weighted-
average
Exercise Price of
Outstanding
Options
Number of
Shares
Subject to
Outstanding
RSUs
Weighted-
average
Fair Value per
Share at
Grant
Number of
Shares
Outstanding
Subject to
Vesting or
Performance
Conditions with
vesting
Weighted-
average
Fair Value per
Share at
Grant
9,953 $
356
(1,333)
—
(562)
8,414
321
(784)
—
(297)
7,654
629
(1,265)
—
(127)
16.01
14.90
7.77
—
25.43
16.63
14.90
9.60
—
26.17
16.91
21.98
8.87
—
29.15
2,260 $
950
—
(603)
(565)
2,042
1,170
—
(657)
(658)
1,897
471
—
(797)
(29)
21.51
14.66
—
14.62
29.78
14.15
10.55
—
13.20
26.26
12.45
24.96
—
13.89
15.35
77 $
—
—
(20)
—
57
—
—
(24)
—
33
2,483
—
(74)
—
24.42
—
—
20.18
—
25.87
—
—
25.55
—
26.10
24.42
—
24.96
—
6,891
18.62
1,542
15.47
2,442
24.42
(in thousands, except per
share data)
Balance at December 31,
2008
Granted
Exercised
Released RSUs/RSAs
Forfeited
Balance at December 31,
2009
Granted
Exercised
Released RSUs/RSAs
Forfeited
Balance at December 31,
2010
Granted
Exercised
Released RSUs/RSAs
Forfeited
Balance at December 31,
2011
As of December 31, 2011, the aggregate intrinsic value of the options outstanding was $42.6 million and the aggregate intrinsic value of the options
exercisable was $39.0 million.
The total intrinsic value of the options exercised was $17.1 million in 2011, $7.2 million in 2010, and $10.0 million in 2009. The total estimated fair value of
options vested was $6.4 million in 2011, $8.2 million in 2010, and $15.7 million in 2009.
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THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
10. Stock-Based Compensation (Continued)
Valuation Assumptions
The Company based the range of weighted average estimated values of employee stock option grants and rights granted under the employee stock purchase
plan, as well as the weighted-average assumptions used in calculating these values, on estimates at the date of grant, as follows:
Employee stock options
Risk-free interest rate
Expected life (in years)
Volatility
Dividend yield
Weighted-average estimated fair value of stock options granted
Employee stock purchase plan issuances
Risk-free interest rate
Expected life (in years)
Volatility
Dividend yield
Weighted-average estimated fair value of ESPP issuances
2011
Year Ended December 31,
2010
2009
1.10% - 2.57%
5 - 6
0.49 - 0.55
—%
$11.11
0.05% - 0.54%
0.5 - 2
0.48 - 0.59
—%
$9.46
1.11% - 2.82%
5 - 6
0.48 - 0.52
—%
$7.41
0.19% - 0.79%
0.5 - 2
0.50 - 0.69
—%
$7.63
1.55% - 2.98%
5 - 6
0.48 - 0.57
—%
$7.48
0.17% - 0.88%
0.5 - 2
0.50 - 0.84
—%
$6.42
Range of Stock Option Exercise Prices
As of December 31, 2011, all outstanding options to purchase common stock of the Company are summarized in the following table (in thousands, except
years and per share data):
Range of Exercise Prices
$3.10
$6.15 - $6.70
$8.53
$9.69
$9.70 - $16.00
$16.01 - $21.96
$21.97 - $29.70
$29.71 - $35.46
Total
Options Outstanding
Weighted-
average
Remaining
Contractual
Life in Years
Weighted-
average
Exercise
Prices
Number
Outstanding
Options Exercisable
Weighted-
average
Remaining
Contractual
Life in Years
Weighted-
average
Exercise
Price
Options
Exercisable
557
145
218
1,172
924
1,493
1,385
997
6,891
1.3 $
6.9
0.4
2.3
5.1
5.6
5.5
5.2
4.4
3.10
6.19
8.53
9.69
14.69
18.52
27.34
33.52
18.62
557
99
218
1,172
749
1,061
1,136
997
5,989
1.3 $
6.9
0.4
2.3
4.5
4.1
4.7
5.2
3.7
3.10
6.18
8.53
9.69
15.00
18.34
28.00
33.52
18.61
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Table of Contents
11. Income Taxes
THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
Due to ongoing operating losses and the inability to recognize any income tax benefit, there is no provision for income taxes for any periods presented.
Deferred income taxes reflect the net tax effects of temporary differences between the carrying amounts of assets and liabilities for financial reporting
purposes and the amounts used for income tax purposes. Significant components of the Company's deferred tax assets are as follows:
(in thousands)
Deferred tax assets:
Net operating loss carryforwards
Deferred revenues
Capitalized research and development expenditures
Research and development tax credit carryforwards
Other
Valuation allowance
Net deferred tax assets
December 31,
2011
2010
$
$
359,000 $
56,000
35,000
37,000
31,000
(518,000)
— $
311,000
63,000
34,000
34,000
26,000
(468,000)
—
Realization of deferred tax assets is dependent on future taxable income, if any, the timing and the amount of which are uncertain. Accordingly, the deferred
tax assets have been fully offset by a valuation allowance. The valuation allowance increased by $50.0 million in 2011, $35.0 million in 2010, and $32.0 million
in 2009.
As of December 31, 2011, the Company had federal net operating loss carryforwards of approximately $1,068.2 million, which will expire from 2012
through 2030, and federal research and development tax credit carryforwards of approximately $43.2 million, which will expire from 2018 through 2030. The
Company also had state net operating loss carryforwards of approximately $425.0 million expiring in the years 2012 through 2030 and state research tax credits
of approximately $46.9 million, which do not expire.
The net operating loss deferred tax asset balances as of December 31, 2011 and 2010 do not include excess tax benefits from stock option exercises.
Stockholders' net capital deficiency will be credited if and when such excess tax benefits are ultimately realized.
Utilization of net operating loss and tax credit carryforwards may be subject to a substantial annual limitation due to the ownership change limitations
provided by the Internal Revenue Code and similar state provisions. The Company conducted an analysis through 2011 to determine whether an ownership
change had occurred since inception. The analysis indicated that two ownership changes occurred in prior years. However, notwithstanding the applicable annual
limitations, no portion of the net operating loss or credit carryforwards are expected to expire before becoming available to reduce federal and state income tax
liabilities. Annual limitations may result in expiration of net operating loss and tax credit carryforwards before some or all of such amounts have been utilized.
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11. Income Taxes (Continued)
Uncertain Tax Positions
THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
A reconciliation of the beginning and ending balances of the total amounts of gross unrecognized tax benefits are as follows (in thousands):
Gross unrecognized tax benefits as of January 1, 2009
Gross decrease for tax positions for prior years
Gross increase in tax positions for current year
Unrecognized tax benefits as of December 31, 2009
Gross decrease for tax positions for prior years
Gross increase in tax positions for current year
Unrecognized tax benefits as of December 31, 2010
Gross decrease for tax positions for prior years
Gross increase in tax positions for current year
Unrecognized tax benefits as of December 31, 2011
$ 36,200
(100)
3,500
39,600
—
3,000
42,600
—
4,300
$ 46,900
If the Company eventually is able to recognize these uncertain positions, most of the $46.9 million of the unrecognized benefit would reduce the effective
tax rate, except for excess tax benefits related to stock-based payments. The Company currently has a full valuation allowance against its deferred tax asset which
would impact the timing of the effective tax rate benefit should any of these uncertain positions be favorably settled in the future. The Company does not believe
it is reasonably possible that its unrecognized tax benefits will significantly change within the next twelve months.
The Company is subject to taxation in the U.S. and various state jurisdictions. The tax years 1996 and forward remain open to examination by the federal and
most state tax authorities due to net operating loss and overall credit carryforward positions.
12. Subsequent Events
Termination of Collaboration Arrangement
On January 6, 2012, Astellas exercised its right to terminate the global License, Development and Commercialization agreement for VIBATIV®. The
Company is evaluating global commercialization alternatives for VIBATIV® either alone or with partners. The rights granted to Astellas ceased upon termination
of the agreement and Astellas has stopped promotional sales efforts. Pursuant to the terms of the agreement, there are no termination payments required by either
party and Astellas is entitled to a ten-year, 2% royalty on future net sales of VIBATIV®.
This is being accounted for as a nonrecognized subsequent event as the termination agreement was entered into after December 31, 2011. The Company is
evaluating the financial impact of the termination. However, the Company expects to recognize in the first quarter of 2012 the remaining non-cash, deferred
upfront license fees and milestone payments, net of any estimated termination obligations, of approximately $125.0 million and the Company may purchase
certain VIBATIV® inventory from Astellas in 2012. The purchase is subject to release of the inventory by a third-party manufacturer and may cost up to
$11.0 million.
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Table of Contents
12. Subsequent Events (Continued)
Sale of Stock
THERAVANCE, INC.
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS (Continued)
On February 14, 2012, the Company and GSK entered into an agreement pursuant to which GSK agreed to purchase through an affiliate, in a private
placement, 88,468 shares of the Company's common stock at $18.12 per share, for an aggregate purchase price of $1.6 million, on February 13, 2012 pursuant to
its rights under the Company's governance agreement with GSK dated June 4, 2004, as amended.
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Table of Contents
SUPPLEMENTARY FINANCIAL DATA (UNAUDITED)
(In thousands, except per share amounts)
The following table presents certain unaudited consolidated quarterly financial information for the eight quarters in the period ended December 31, 2011.
This information has been prepared on the same basis as the audited Consolidated Financial Statements and includes all adjustments (consisting only of normal
recurring adjustments) necessary to present fairly the unaudited quarterly results of operations set forth herein.
2011:
Revenue
Operating expenses
Loss from operations
Net loss
Basic and diluted net loss per share
2010:
Revenue
Operating expenses
Loss from operations
Net loss
Basic and diluted net loss per share
March 31
For the Quarters Ended(1)
September 30
June 30
December 31
(in thousands except per share data)
$
$
$
$
6,331 $
(27,633)
(21,302)
(22,667)
(0.28) $
6,389 $
(30,046)
(23,657)
(25,045)
(0.31) $
5,714 $
(26,827)
(21,113)
(22,536)
(0.35) $
6,264 $
(25,696)
(19,432)
(20,806)
(0.28) $
6,431 $
(35,633)
(29,202)
(30,626)
(0.37) $
5,302 $
(25,147)
(19,845)
(21,222)
(0.29) $
5,361
(40,937)
(35,576)
(37,007)
(0.45)
6,942
(24,876)
(17,934)
(19,299)
(0.25)
(1)
The 2011 and 2010 amounts were computed independently for each quarter, and the sum of the quarters may not total the annual
amounts.
87
Table of Contents
The Board of Directors and Stockholders of Theravance, Inc.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We have audited the accompanying consolidated balance sheets of Theravance, Inc. (the "Company") as of December 31, 2011 and 2010, and the related
consolidated statements of operations, stockholders' net capital deficiency, and cash flows for each of the three years in the period ended December 31, 2011.
These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these 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 financial statements referred to above present fairly, in all material respects, the consolidated financial position of Theravance, Inc. at
December 31, 2011 and 2010, and the consolidated results of its operations and its cash flows for each of the three years in the period ended December 31, 2011,
in conformity with U.S. generally accepted accounting principles.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), Theravance, Inc.'s internal
control over financial reporting as of December 31, 2011, based on criteria established in Internal Control—Integrated Framework issued by the Committee of
Sponsoring Organizations of the Treadway Commission and our report dated February 27, 2012 expressed an unqualified opinion thereon.
/s/ ERNST & YOUNG LLP
Redwood City, California
February 27, 2012
88
Table of Contents
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 conducted an evaluation as of December 31, 2011, 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, which are defined under SEC rules
as controls and other procedures of a company that are designed to ensure that information required to be disclosed by a company in the reports that it files under
the Securities Exchange Act of 1934 (Exchange Act) is recorded, processed, summarized and reported within required time periods. Based upon that evaluation,
our Chief Executive Officer and Chief Financial Officer concluded that, as of such date, our disclosure controls and procedures were effective.
Management's Report on Internal Control over Financial Reporting
Our management is responsible for establishing and maintaining adequate internal control over financial reporting as defined in Rule 13a-15(f) of the
Exchange Act. 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 our assets; (2) provide reasonable assurance that transactions are recorded as necessary to
permit preparation of financial statements in accordance with generally accepted accounting principles, and that our receipts and expenditures are being made
only in accordance with authorizations of our management and directors; and (3) provide reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of our assets that could have a material effect on the financial statements.
Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we conducted an
evaluation of the effectiveness of our internal control over financial reporting based on criteria established in the Internal Control—Integrated Framework issued
by the Committee of Sponsoring Organizations of the Treadway Commission. Management's assessment included evaluation of such elements as the design and
operating effectiveness of key financial reporting controls, process documentation, accounting policies, and our overall control environment. Based on this
evaluation, our management concluded that our internal control over financial reporting was effective as of December 31, 2011.
Our independent registered public accounting firm, Ernst & Young LLP, has audited our internal control over financial reporting as of December 31, 2011.
Their attestation report on the audit of our internal control over financial reporting is included below.
Limitations on the Effectiveness of Controls
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or our
internal control over financial reporting will prevent all error and all fraud. A control system, no matter how well conceived and operated, can provide only
reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of a control system must reflect the fact that there are
resource constraints, and the benefit of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation
of controls can provide absolute assurance that all control issues and instances of fraud, if any, within Theravance have been detected. Also, projections of any
evaluation of
89
Table of Contents
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.
Changes in Internal Control over Financial Reporting
There was no change in our internal control over financial reporting (as defined in Rule 13a-15(f) of the Exchange Act) identified in connection with the
evaluation required by paragraph (d) of Rule 13a-15 of the Exchange Act, which occurred during the fourth fiscal quarter of the year ended December 31, 2011
which has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
90
Table of Contents
The Board of Directors and Stockholders of Theravance, Inc.
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
We have audited Theravance, Inc.'s internal control over financial reporting as of December 31, 2011, based on criteria established in Internal Control—
Integrated Framework issued by the Committee of Sponsoring Organizations of the Treadway Commission (the COSO criteria). Theravance, 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. Our responsibility is to express an opinion on the
company's internal control over financial reporting based on our audit.
We conducted our audit in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that
we plan and perform the audit to obtain reasonable assurance about whether effective internal control over financial reporting was maintained in all material
respects. Our audit included obtaining an understanding of internal control over financial reporting, assessing the risk that a material weakness exists, testing and
evaluating the design and operating effectiveness of internal control based on the assessed risk, and performing such other procedures as we considered necessary
in the circumstances. We believe that our audit provides a reasonable basis for our opinion.
A company's internal control over financial reporting is a process designed to provide reasonable assurance regarding the reliability of financial reporting
and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles. A company's internal control over
financial reporting includes those policies and procedures that (1) pertain to the maintenance of records that, in reasonable detail, accurately and fairly reflect the
transactions and dispositions of the assets of the company; (2) provide reasonable assurance that transactions are recorded as necessary to permit preparation of
financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the company are being made only in
accordance with authorizations of management and directors of the company; and (3) provide reasonable assurance regarding prevention or timely detection of
unauthorized acquisition, use or disposition of the company's assets that could have a material effect on the financial statements.
Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of
effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that the degree of compliance with
the policies or procedures may deteriorate.
In our opinion, Theravance, Inc. maintained, in all material respects, effective internal control over financial reporting as of December 31, 2011, based on the
COSO criteria.
We also have audited, in accordance with the standards of the Public Company Accounting Oversight Board (United States), the consolidated balance sheets
of Theravance, Inc. as of December 31, 2011 and 2010, and the related consolidated statements of operations, stockholders' net capital deficiency, and cash flows
for each of the three years in the period ended December 31, 2011 of Theravance, Inc. and our report dated February 27, 2012 expressed an unqualified opinion
thereon.
/s/ ERNST & YOUNG LLP
Redwood City, California
February 27, 2012
91
Table of Contents
ITEM 9B. OTHER INFORMATION
None.
ITEM 10. DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
PART III
For the information required by this Item, see "Questions and Answers About this Proxy Material and Voting", "Election of Directors", "Nominees",
"Meetings of the Board of Directors", "Executive Officers", "Section 16(a) Beneficial Ownership Reporting Compliance", "Audit Committee" and "Code of
Business Conduct" in the Proxy Statement to be filed with the SEC, which sections are incorporated herein by reference.
ITEM 11. EXECUTIVE COMPENSATION
For the information required by this Item, see "2011 Director Compensation", "Compensation of Named Executive Officers", "Compensation Committee
Report" and "Compensation Committee Interlocks and Insider Participation" in the Proxy Statement to be filed with the SEC, which sections are incorporated
herein by reference.
ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED STOCKHOLDER
MATTERS
For the information required by this Item, see "Security Ownership of Certain Beneficial Owners and Management" and "Securities Authorized for Issuance
Under Equity Compensation Plans" in the Proxy Statement to be filed with the SEC, which sections are incorporated herein by reference.
ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
For the information required by this Item, see "Independence of the Board of Directors" and "Review, Approval or Ratification of Transactions with Related
Persons" in the Proxy Statement to be filed with the SEC, which sections are incorporated herein by reference.
ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES
For the information required by this Item, see "Ratification of Section of Independent Registered Public Accounting Firm" and "Pre-Approval Policies and
Procedures" in the Proxy Statement to be filed with the SEC, which sections are incorporated herein by reference.
92
Table of Contents
ITEM 15. EXHIBITS AND FINANCIAL STATEMENT SCHEDULES
(a)
The following documents are filed as part of this Annual Report on Form 10-K:
PART IV
1.
Financial Statements:
The following financial statements and schedules of the Registrant are contained in Part II, Item 8, "Financial Statements and Supplementary Data" of this
Annual Report on Form 10-K:
Consolidated Balance Sheets as of December 31, 2011 and 2010
Consolidated Statements of Operations for each of the three years in the period ended December 31, 2011
Consolidated Statements of Stockholders' Net Capital Deficiency for each of the three years in the period ended
December 31, 2011
Consolidated Statements of Cash Flows for each of the three years in the period ended December 31, 2011
Notes to Consolidated Financial Statements
Report of Independent Registered Public Accounting Firm
57
58
59
60
61
88
2.
Financial Statement Schedules:
All schedules are omitted because they are either not applicable or the required information is shown in the Consolidated Financial Statements or notes
thereto.
(b)
Exhibits required by Item 601 of Regulation S-K
The information required by this Item is set forth on the exhibit index that follows the signature page of this report.
93
Table of Contents
Pursuant to the requirements of Section 13 or 15(d) 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.
SIGNATURES
Date: February 27, 2012
By:
/s/ RICK E WINNINGHAM
THERAVANCE, INC.
Rick E Winningham
Chief Executive Officer
POWER OF ATTORNEY
KNOWN ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Rick E Winningham and
Michael W. Aguiar, each of whom may act without joinder of the other, as their true and lawful attorneys-in-fact and agents, each with full power of substitution
and resubstitution, for such person and in his or her name, place and stead, in any and all capacities, to sign any and all amendments to the annual report on
Form 10-K, and to file the same, with all exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, granting
unto said attorneys-in-fact and agents full power and authority to do and perform each and every act and thing requisite and necessary to be done in and about the
premises, as fully to all intents and purposes as he or she could do in person, hereby ratifying and confirming all that said attorneys-in-fact and agents, or their
substitutes, may lawfully do or cause to be done by virtue hereof.
Pursuant to the requirements of the Securities Exchange Act of 1934, this 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/ RICK E WINNINGHAM
Chairman of the Board and Chief Executive
February 27, 2012
Rick E Winningham
Officer (Principal Executive Officer)
/s/ MICHAEL W. AGUIAR
Michael W. Aguiar
Senior Vice President, Finance and Chief
Financial Officer (Principal Financial and
Accounting Officer)
February 27, 2012
/s/ JEFFREY M. DRAZAN
Director
February 27, 2012
Jeffrey M. Drazan
/s/ HENRIETTA HOLSMAN FORE
Director
February 27, 2012
Henrietta Holsman Fore
94
Table of Contents
Signature
Title
Date
/s/ ROBERT V. GUNDERSON, JR.
Robert V. Gunderson, Jr.
Director
February 27, 2012
/s/ ARNOLD J. LEVINE, PH.D.
Arnold J. Levine, Ph.D
Director
February 27, 2012
/s/ BURTON G. MALKIEL, PH.D.
Burton G. Malkiel, Ph.D
Director
February 27, 2012
/s/ PETER S. RINGROSE, PH.D.
Peter S. Ringrose, Ph.D.
Director
February 27, 2012
/s/ WILLIAM H. WALTRIP
William H. Waltrip
Director
February 27, 2012
/s/ GEORGE M. WHITESIDES, PH.D.
George M. Whitesides, Ph.D
Director
February 27, 2012
/s/ WILLIAM D. YOUNG
William D. Young
Director
February 27, 2012
95
Table of Contents
Exhibits
Exhibit
Number
3.3
Description
Amended and Restated Certificate of Incorporation
Incorporated by
Reference
Filing
Date/Period
End Date
7/26/04
Form
S-1
3.4
Certificate of Amendment of Restated Certificate of Incorporation
10-Q
3/31/07
3.5
Amended and Restated Bylaws (as amended by the board of directors April 25, 2007)
10-Q
9/30/08
4.1
Specimen certificate representing the common stock of the registrant
10-K
12/31/06
4.2
4.3
Amended and Restated Rights Agreement between the registrant and The Bank of New
York, as Rights Agent, dated as of June 22, 2007
10-Q
6/30/07
Indenture dated as of January 23, 2008 by and between Theravance, Inc. and The Bank of
New York Trust Company, N.A., as trustee
8-K
1/23/08
4.4
Form of 3.0% Convertible Subordinated Note Due 2015 (included in Exhibit 4.3)
4.5
Amendment to Amended and Restated Rights Agreement between the registrant and The
Bank of New York Mellon Corporation, as Rights Agent, dated November 21, 2008
8-K
11/25/08
10.1+
1997 Stock Plan
10.2+
Long-Term Stock Option Plan
S-1
6/10/04
S-1
6/10/04
10.3+
2004 Equity Incentive Plan, as amended by the board of directors February 10, 2010 and
approved by stockholders April 27, 2010 and forms of equity award
10.4
Employee Stock Purchase Plan, as amended April 27, 2010
10-Q
6/30/10
10.5+
Change in Control Severance Plan, as amended and restated on July 27, 2007
10-Q
6/30/08
10.6
10.7
Amended and Restated Lease Agreement, 951 Gateway Boulevard, between the registrant
and HMS Gateway Office L.P., dated January 1, 2001
S-1
6/10/04
Lease Agreement, 901 Gateway Boulevard, between the registrant and HMS Gateway
Office L.P., dated January 1, 2001
S-1
6/10/04
10.8*
Collaboration Agreement between the registrant and Glaxo Group Limited, dated as of
November 14, 2002
S-1
9/29/04
10.9+
Form of Indemnification Agreement for directors and officers of the registrant
S-1
6/10/04
10.10
10.11
10.12
Class A Common Stock Purchase Agreement between the registrant and SmithKline
Beecham Corporation, dated as of March 30, 2004
S-1
6/10/04
Amended and Restated Investors' Rights Agreement by and among the registrant and the
parties listed therein, dated as of May 11, 2004
S-1
6/10/04
Amended and Restated Governance Agreement by and among the registrant, SmithKline
Beecham Corporation and GlaxoSmithKline dated as of June 4, 2004
S-1
7/26/04
Table of Contents
Exhibit
Number
10.13*
Description
Strategic Alliance Agreement between the registrant and Glaxo Group Limited, dated as of
March 30, 2004
Form
S-1
Filing
Date/Period
End Date
9/30/04
Incorporated by
Reference
10.14*
License Agreement between the registrant and Janssen Pharmaceutica, dated as of May 14,
2002
S-1
9/29/04
10.15+
Offer Letter with Rick E Winningham dated August 23, 2001
S-1
6/10/04
10.16
Form of Class A Common Stock Purchase Agreement between the registrant and GSK
S-1
9/29/04
10.17+
Offer Letter with Michael W. Aguiar dated as of January 31, 2005
10-K
12/31/04
10.18+
Form of Notice of Grant and Stock Option Agreement under 2004 Equity Incentive Plan
10-K
12/31/04
10.19+
Form of Notice of Restricted Stock Award and Restricted Stock Agreement under 2004
Equity Incentive Plan (form in effect through 2010)
10-Q
6/30/07
10.20+
Description of Cash Bonus Program, as amended
10.21*
License, Development and Commercialization Agreement between the registrant and
Astellas Pharma Inc. dated November 7, 2005
10-K
12/31/09
S-3
1/30/06
10.22*
Amendment to License, Development and Commercialization Agreement between the
registrant and Astellas Pharma Inc. dated as of July 18, 2006
10-Q
9/30/06
10.23+
Offer letter with Leonard Blum dated July 27, 2007
10-Q
9/30/07
10.24+
Amended and Restated 2008 New Employee Equity Incentive Plan and forms of equity
award
10.25+
Amendment to Offer Letter between the registrant and Leonard Blum dated July 23, 2008
10-K
12/31/08
10.26+
Amendment to Offer Letter between the registrant and Rick E Winningham dated
December 23, 2008
10-K
12/31/08
10.27+
Amendment to Change in Control Severance Plan effective December 16, 2009
10-K
12/31/09
10.28+
2010 Change in Control Severance Plan adopted December 16, 2009
10-K
12/31/09
10.29
10.30
10.31
10.32
First Amendment to Lease for 901 Gateway Boulevard effective as of June 1, 2010 between
ARE-901/951 Gateway Boulevard, LLC and the registrant
10-Q
6/30/10
First Amendment to Lease for 951 Gateway Boulevard effective as of June 1, 2010 between
ARE-901/951 Gateway Boulevard, LLC and the registrant
10-Q
6/30/10
Common Stock Purchase Agreement among the registrant, Glaxo Group Limited and
GlaxoSmithKline LLC, dated as of November 29, 2010
Second Amendment to Amended and Restated Governance Agreement among the registrant,
Glaxo Group Limited, GlaxoSmithKline plc and GlaxoSmithKline LLC, dated as of
November 29, 2010
8-K
11/29/10
8-K
11/29/10
Table of Contents
Exhibit
Number
10.33+
Form of Amendment to Restricted Stock Unit Agreements between the registrant and each
current member of the Board of Directors outstanding as of December 31, 2010
Description
10.34(1) Amendment to Strategic Alliance Agreement dated October 3, 2011
Incorporated by
Reference
Filing
Date/Period
End Date
Form
10-K 12/31/2010
21.1
List of Subsidiaries
10-K
12/31/05
23.1
Consent of Independent Registered Public Accounting Firm
24.1
Power of Attorney (see signature page to this Annual Report on Form 10-K)
31.1
31.2
Certification of Chief Executive Officer Pursuant to Rule 13a-14 under the Securities
Exchange Act of 1934
Certification of Chief Financial Officer Pursuant to Rule 13a-14 under the Securities
Exchange Act of 1934
32
Certifications Pursuant to 18 U.S.C. Section 1350
101^
The following materials from Registrant's Annual Report on Form 10-K for the year ended
December 31, 2011, formatted in Extensible Business Reporting Language (XBRL)
includes: (i) Consolidated Balance Sheets at December 31, 2011 and 2010, (ii) Consolidated
Statements of Income for the years ended December 31, 2011, 2010 and 2009,
(iii) Consolidated Statements of Stockholders' Equity for the years ended December 31,
2011, 2010 and 2009, (iv) Consolidated Statements of Cash Flows for years ended
December 31, 2011, 2010 and 2009 and (v) Notes to Consolidated Financial Statements.
+
*
(1)
^
Management contract or compensatory plan or arrangement required to be filed pursuant to Item 15(b) of Form 10-K.
Confidential treatment has been requested for certain portions which are omitted in the copy of the exhibit electronically filed with the
Securities and Exchange Commission. The omitted information has been filed separately with the Securities and Exchange Commission
pursuant to Theravance Inc.'s application for confidential treatment.
Application has been made to the Securities and Exchange Commission to seek confidential treatment of certain provisions. Omitted
material for which confidential treatment has been requested has been filed separately with the Securities and Exchange Commission.
XBRL information is furnished and not filed or a part of a registration statement or prospectus for purposes of sections 11 or 12 of the
Securities Exchange Act of 1933, as amended, is deemed not filed for purposes of section 18 of the Securities Exchange Act of 1934, as
amended, and otherwise is not subject to liability under these sections.
THERAVANCE, INC.
2004 EQUITY INCENTIVE PLAN
(AS AMENDED AND RESTATED FEBRUARY 10, 2010)
TABLE OF CONTENTS
ARTICLE I.
INTRODUCTION
ARTICLE II.
2.1
2.2
2.3
ARTICLE III.
3.1
3.2
3.3
ARTICLE IV.
4.1
4.2
ARTICLE V.
5.1
5.2
5.3
5.4
5.5
5.6
ARTICLE VI.
6.1
6.2
6.3
6.4
6.5
6.6
ARTICLE VII.
7.1
7.2
7.3
7.4
7.5
7.6
ADMINISTRATION
Committee Composition
Committee Responsibilities
Committee for Non-Officer Grants
SHARES AVAILABLE FOR GRANTS
Basic Limitation
Additional Shares
Shares Subject to Substituted Awards
ELIGIBILITY
Incentive Stock Options
Other Grants
OPTIONS
Stock Option Agreement
Number of Shares
Exercise Price
Exercisability and Term
Modification or Assumption of Options
Buyout Provisions
PAYMENT FOR OPTION SHARES
General Rule
Surrender of Stock
Exercise/Sale
Exercise/Pledge
Promissory Note
Other Forms of Payment
STOCK APPRECIATION RIGHTS
SAR Agreement
Number of Shares
Exercise Price
Exercisability and Term
Exercise of SARs
Modification or Assumption of SARs
ARTICLE VIII.
8.1
8.2
8.3
RESTRICTED SHARES
Restricted Stock Agreement
Payment for Awards
Vesting Conditions
i
8.4
Voting and Dividend Rights
ARTICLE IX.
9.1
9.2
9.3
9.4
9.5
9.6
9.7
9.8
STOCK UNITS AND PERFORMANCE CASH AWARDS
Stock Unit Agreement
Payment for Awards
Vesting Conditions
Voting and Dividend Rights
Form and Time of Settlement of Stock Units
Death of Recipient
Creditors’ Rights
Performance Cash Awards
Exhibit 10.3
Page
1
1
1
1
2
2
2
2
3
3
3
3
3
3
3
4
4
4
4
4
4
5
5
5
5
5
5
5
5
6
6
6
6
7
7
7
7
7
8
8
8
8
8
8
9
9
9
ARTICLE X.
10.1
10.2
ARTICLE XI.
11.1
11.2
11.3
CHANGE IN CONTROL
Effect of Change in Control
Acceleration
PROTECTION AGAINST DILUTION
Adjustments
Dissolution or Liquidation
Reorganizations
ARTICLE XII.
DEFERRAL OF AWARDS
ARTICLE XIII.
AWARDS UNDER OTHER PLANS
ARTICLE XIV.
14.1
14.2
14.3
ARTICLE XV.
15.1
15.2
15.3
15.4
ARTICLE XVI.
16.1
16.2
ARTICLE XVII.
17.1
17.2
17.3
PAYMENT OF FEES IN SECURITIES
Effective Date
Elections to Receive NSOs, Restricted Shares or Stock Units
Number and Terms of NSOs, Restricted Shares or Stock Units
LIMITATION ON RIGHTS
Retention Rights
Stockholders’ Rights
Regulatory Requirements
Transferability of Awards
WITHHOLDING TAXES
General
Share Withholding
FUTURE OF THE PLAN
Term of the Plan
Amendment or Termination
Stockholder Approval
ARTICLE XVIII.
DEFINITIONS
ii
THERAVANCE, INC.
2004 EQUITY INCENTIVE PLAN
9
9
10
10
10
10
10
11
12
12
12
12
12
13
13
13
13
13
13
13
14
14
14
14
14
15
ARTICLE I. INTRODUCTION.
The Plan was adopted by the Board on May 27, 2004 to be effective at the IPO, and the amendment and restatement of the Plan was approved by the
Board and the Compensation Committee of the Board on February 10, 2010 to be effective on the date of the Corporation’s 2010 Annual Meeting of
Stockholders assuming the Plan is approved by the Corporation’s stockholders at such meeting. The purpose of the Plan is to promote the long-term success
of the Corporation and the creation of stockholder value by (a) encouraging Employees, Outside Directors and Consultants to focus on critical long-range
objectives, (b) encouraging the attraction and retention of Employees, Outside Directors and Consultants with exceptional qualifications, and (c) linking
Employees, Outside Directors and Consultants directly to stockholder interests through increased stock ownership. The Plan seeks to achieve this purpose by
providing for the following Awards: (i) Options (which may constitute incentive stock options or nonstatutory stock options), (ii) stock appreciation rights,
(iii) Restricted Shares, (iv) Stock Units and (v) Performance Cash Awards.
The Plan shall be governed by, and construed in accordance with, the laws of the State of Delaware (except their choice-of-law provisions).
ARTICLE II. ADMINISTRATION.
2.1 Committee Composition. The Committee shall administer the Plan. The Committee shall consist exclusively of two or more directors of
the Corporation, who shall be appointed by the Board. In addition, each member of the Committee shall meet the following requirements:
(a) Any listing standards prescribed by the principal securities market on which the Corporation’s equity securities are traded;
(b) Such requirements as the Internal Revenue Service may establish for outside directors acting under plans intended to qualify for
exemption under section 162(m)(4)(C) of the Code;
(c) Such requirements as the Securities and Exchange Commission may establish for administrators acting under plans intended to
qualify for exemption under Rule 16b-3 (or its successor) under the Exchange Act; and
(d) Any other requirements imposed by applicable law, regulations or rules.
2.2 Committee Responsibilities. The Committee shall (a) select the Employees, Outside Directors and Consultants who are to receive Awards
under the Plan, (b) determine the type, number, vesting requirements and other features and conditions of such Awards, (c) interpret the Plan, (d) make all
other decisions relating to the operation of the Plan and
(e) carry out any other duties delegated to it by the Board. The Committee may adopt such rules or guidelines as it deems appropriate to implement the Plan.
The Committee’s determinations under the Plan shall be final and binding on all persons.
2.3 Committee for Non-Officer Grants. The Board may also appoint a secondary committee of the Board, which shall be composed of one or
more directors of the Corporation who need not satisfy the requirements of Section 2.1. Such secondary committee may administer the Plan with respect to
Employees and Consultants who are not Outside Directors and are not considered executive officers of the Corporation under section 16 of the Exchange Act,
may grant Awards under the Plan to such Employees and Consultants and may determine all features and conditions of such Awards. Within the limitations
of this Section 2.3, any reference in the Plan to the Committee shall include such secondary committee.
ARTICLE III. SHARES AVAILABLE FOR GRANTS.
3.1 Basic Limitation. Shares of Common Stock issued pursuant to the Plan may be authorized but unissued shares or treasury shares. The
aggregate number of shares of Common Stock that may be awarded pursuant to Stock Awards granted under the Plan on or after January 1, 2010 shall not
exceed (a) 7,600,000 shares (which includes 1,541,428 shares remaining available for issuance under the Plan as of January 1, 2010) and (b) the additional
shares of Common Stock described in Sections 3.2 and 3.3(1). The number of shares of Common Stock that may be awarded pursuant to ISOs granted under
the Plan on or after January 1, 2010 shall not exceed 7,600,000 shares. The number of shares of Common Stock that may be awarded under the Plan on or
after January 1, 2010 shall be reduced by (a) one share for every option and stock appreciation right granted under the Plan or the Corporation’s 2008 New
Employee Equity Incentive Plan on or after January 1, 2010 and (b) 1.45 shares for every stock award other than an option or stock appreciation right granted
under the Plan or the Corporation’s 2008 New Employee Equity Incentive Plan on or after January 1, 2010. The limitations of this Section 3.1 shall be
subject to adjustment pursuant to Article 11. The number of shares of Common Stock that are subject to Options or other rights outstanding at any time under
the Plan shall not exceed the number of shares of Common Stock that then remain available for issuance under the Plan. No further awards shall be granted
under the Predecessor Plans after the dates specified in Section 17.1.
3.2 Additional Shares. If restricted shares or shares of Common Stock issued upon the exercise of options under this Plan or the Predecessor
Plans are forfeited or repurchased, then such shares of Common Stock shall again become available for Stock Awards under this Plan. If stock units, options
or stock appreciation rights under this Plan or the Predecessor Plans are forfeited, settled in cash (in whole or in part) or terminate for any other reason before
being exercised, then the corresponding shares of Common Stock shall again become available for
(1) The history of the Plan’s share reserve prior to January 1, 2010 includes the following: (i) an initial share reserve of 13,034,369 shares (consisting of
3,700,000 shares plus 9,334,369 shares remaining available for issuance under the Pre-IPO Plans on the date of effectiveness of the IPO) and (ii) an increase
of 3,500,000 shares approved by the Compensation Committee of the Board of Directors on November 29, 2006 and the Board of Directors on December 6,
2006 (all share numbers in clause (i) reflect the reverse stock split approved in connection with the Corporation’s IPO).
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Stock Awards under this Plan. Notwithstanding anything to the contrary contained herein, on or after January 1, 2010, the following shares of Common Stock
shall not be added back to the number of shares available for Stock Awards under Section 3.1: (i) shares tendered by a Participant or withheld by the
Corporation in payment of the exercise price of an option granted under this Plan or the Predecessor Plans, or to satisfy any tax withholding obligation with
respect to a stock award granted under this Plan or the Predecessor Plans, (ii) shares subject to a stock appreciation right issued under this Plan or the
Predecessor Plans that are not issued in connection with the stock settlement of the stock appreciation right on exercise thereof and (iii) shares reacquired by
the Corporation on the open market or otherwise using cash proceeds from the exercise of an option granted under this Plan or the Predecessor Plans. On or
after January 1, 2010, any shares that again become available for Stock Awards under this Section 3.2 shall be added back as (i) one share if such shares were
subject to options or stock appreciation rights granted under this Plan or the Predecessor Plans and (ii) 1.45 shares if such shares were subject to stock awards
other than options or stock appreciation rights that were granted under this Plan or the Predecessor Plans.
3.3 Shares Subject to Substituted Awards. The number of shares of Common Stock subject to Substitute Awards granted by the Corporation
shall not reduce the number of shares of Common Stock that may be issued under Section 3.1, nor shall shares subject to Substitute Awards again be available
for Awards under the Plan to the extent of any forfeiture, expiration or cash settlement as provided under Section 3.2.
ARTICLE IV. ELIGIBILITY.
4.1 Incentive Stock Options. Only Employees who are common-law employees of the Corporation, a Parent or a Subsidiary shall be eligible
for the grant of ISOs. In addition, an Employee who owns more than 10% of the total combined voting power of all classes of outstanding stock of the
Corporation or any of its Parents or Subsidiaries shall not be eligible for the grant of an ISO unless the requirements set forth in section 422(c)(6) of the Code
are satisfied.
4.2 Other Grants. Awards other than ISOs may only be granted to Employees, Outside Directors and Consultants.
ARTICLE V. OPTIONS.
5.1 Stock Option Agreement. Each grant of an Option under the Plan shall be evidenced by a Stock Option Agreement between the Optionee
and the Corporation. Such Option shall be subject to all applicable terms of the Plan and may be subject to any other terms that are not inconsistent with the
Plan. The Stock Option Agreement shall specify whether the Option is an ISO or an NSO. The provisions of the various Stock Option Agreements entered
into under the Plan need not be identical. Options may be granted in consideration of a reduction in the Optionee’s other compensation.
5.2 Number of Shares. Each Stock Option Agreement shall specify the number of shares of Common Stock subject to the Option and shall
provide for the adjustment of such number in accordance with Article 11. Options granted to any Optionee in a single fiscal year of
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the Corporation shall not cover more than 1,500,000 shares of Common Stock, except that Options granted to a new Employee in the fiscal year of the
Corporation in which his or her service as an Employee first commences shall not cover more than 2,000,000 shares of Common Stock. The limitations set
forth in the preceding sentence shall be subject to adjustment in accordance with Article 11.
5.3 Exercise Price. Each Stock Option Agreement shall specify the Exercise Price; provided that the Exercise Price shall in no event be less
than 100% of the Fair Market Value of a share of Common Stock on the date of grant. This Section 5.3 shall not apply to an Option granted pursuant to an
assumption of, or substitution for, another option in a manner that complies with Section 424(a) of the Code (whether or not the Option is an ISO).
5.4 Exercisability and Term. Each Stock Option Agreement shall specify the date or event when all or any installment of the Option is to
become exercisable. The Stock Option Agreement shall also specify the term of the Option; provided that the term of an Option shall in no event exceed
10 years from the date of grant. A Stock Option Agreement may provide for accelerated exercisability in the event of a Change in Control, the Optionee’s
death, disability or retirement or other events and may provide for expiration prior to the end of its term in the event of the termination of the Optionee’s
service. Options may be awarded in combination with SARs, and such an Award may provide that the Options will not be exercisable unless the related
SARs are forfeited.
5.5 Modification or Assumption of Options. Within the limitations of the Plan, the Committee may modify, extend, or assume outstanding
options. The foregoing notwithstanding, no modification of an Option shall, without the consent of the Optionee, alter or impair his or her rights or
obligations under such Option. Notwithstanding anything in this Plan to the contrary, and except for the adjustments provided in Articles 10 and 11, neither
the Committee nor any other person may (a) decrease the exercise price for any outstanding Option after the date of grant, (b) cancel or allow an optionee to
surrender an outstanding Option to the Corporation in exchange for cash or as consideration for the grant of a new Option with a lower exercise price or the
grant of another type of Award the effect of which is to reduce the exercise price of any outstanding Option or (c) take any other action with respect to an
Option that would be treated as a repricing under the rules and regulations of the NASDAQ Stock Market (or such other principal U.S. national securities
exchange on which the Corporation’s Common Stock is traded).
5.6 Buyout Provisions. Except to the extent prohibited by Section 5.5, the Committee may at any time (a) offer to buy out for a payment in
cash or cash equivalents an Option previously granted or (b) authorize an Optionee to elect to cash out an Option previously granted, in either case at such
time and based upon such terms and conditions as the Committee shall establish.
ARTICLE VI. PAYMENT FOR OPTION SHARES.
6.1 General Rule. The entire Exercise Price of shares of Common Stock issued upon exercise of Options shall be payable in cash or cash
equivalents at the time such shares of Common Stock are purchased, except that the Committee at its sole discretion may accept
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payment of the Exercise Price in any other form(s) described in this Article 6. However, if the Optionee is an Outside Director or executive officer of the
Corporation, he or she may pay the Exercise Price in a form other than cash or cash equivalents only to the extent permitted by section 13(k) of the Exchange
Act.
6.2 Surrender of Stock. With the Committee’s consent, all or any part of the Exercise Price may be paid by surrendering, or attesting to the
ownership of, shares of Common Stock that are already owned by the Optionee. Such shares of Common Stock shall be valued at their Fair Market Value on
the date the new shares of Common Stock are purchased under the Plan. The Optionee shall not surrender, or attest to the ownership of, shares of Common
Stock in payment of the Exercise Price if such action would cause the Corporation to recognize compensation expense (or additional compensation expense)
with respect to the Option for financial reporting purposes.
6.3 Exercise/Sale. With the Committee’s consent, all or any part of the Exercise Price and any withholding taxes may be paid by delivering (on
a form prescribed by the Corporation) an irrevocable direction to a securities broker approved by the Corporation to sell all or part of the shares of Common
Stock being purchased under the Plan and to deliver all or part of the sales proceeds to the Corporation.
6.4 Exercise/Pledge. With the Committee’s consent, all or any part of the Exercise Price and any withholding taxes may be paid by delivering
(on a form prescribed by the Corporation) an irrevocable direction to pledge all or part of the shares of Common Stock being purchased under the Plan to a
securities broker or lender approved by the Corporation, as security for a loan, and to deliver all or part of the loan proceeds to the Corporation.
6.5 Promissory Note. To the extent permitted by Section 13(k) of the Exchange Act, with the Committee’s consent, all or any part of the
Exercise Price and any withholding taxes may be paid by delivering (on a form prescribed by the Corporation) a full-recourse promissory note. However, the
par value of the shares of Common Stock being purchased under the Plan, if newly issued, shall be paid in cash or cash equivalents.
6.6 Other Forms of Payment. With the Committee’s consent, all or any part of the Exercise Price and any withholding taxes may be paid in
any other form that is consistent with applicable laws, regulations and rules.
ARTICLE VII. STOCK APPRECIATION RIGHTS.
7.1 SAR Agreement. Each grant of an SAR under the Plan shall be evidenced by an SAR Agreement between the Optionee and the
Corporation. Such SAR shall be subject to all applicable terms of the Plan and may be subject to any other terms that are not inconsistent with the Plan. The
provisions of the various SAR Agreements entered into under the Plan need not be identical. SARs may be granted in consideration of a reduction in the
Optionee’s other compensation.
7.2 Number of Shares. Each SAR Agreement shall specify the number of shares of Common Stock to which the SAR pertains and shall
provide for the adjustment of such number in accordance with Article 11. SARs granted to any Optionee in a single fiscal year shall in no
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event pertain to more than 1,500,000 shares of Common Stock, except that SARs granted to a new Employee in the fiscal year of the Corporation in which his
or her service as an Employee first commences shall not pertain to more than 2,000,000 shares of Common Stock. The limitations set forth in the preceding
sentence shall be subject to adjustment in accordance with Article 11.
7.3 Exercise Price. Each SAR Agreement shall specify the Exercise Price which, except with respect to Substitute Awards, shall not be less
than Fair Market Value. An SAR Agreement may specify an Exercise Price that varies in accordance with a predetermined formula while the SAR is
outstanding.
7.4 Exercisability and Term. Each SAR Agreement shall specify the date all or any installment of the SAR is to become exercisable. The
SAR Agreement shall also specify the term of the SAR; provided that the term of a SAR shall in no event exceed 10 years from the date of grant. An SAR
Agreement may provide for accelerated exercisability in the event of a Change in Control, the Optionee’s death, disability or retirement or other events and
may provide for expiration prior to the end of its term in the event of the termination of the Optionee’s service. SARs may be awarded in combination with
Options, and such an Award may provide that the SARs will not be exercisable unless the related Options are forfeited. An SAR may be included in an ISO
only at the time of grant but may be included in an NSO at the time of grant or thereafter. An SAR granted under the Plan may provide that it will be
exercisable only in the event of a Change in Control.
7.5 Exercise of SARs. Upon exercise of an SAR, the Optionee (or any person having the right to exercise the SAR after his or her death) shall
receive from the Corporation (a) shares of Common Stock, (b) cash or (c) a combination of shares of Common Stock and cash, as the Committee shall
determine. The amount of cash and/or the Fair Market Value of shares of Common Stock received upon exercise of SARs shall, in the aggregate, be equal to
the amount by which the Fair Market Value (on the date of surrender) of the shares of Common Stock subject to the SARs exceeds the Exercise Price. If, on
the date an SAR expires, the Exercise Price under such SAR is less than the Fair Market Value on such date but any portion of such SAR has not been
exercised or surrendered, then such SAR shall automatically be deemed to be exercised as of such date with respect to such portion.
7.6 Modification or Assumption of SARs. Within the limitations of the Plan, the Committee may modify, extend or assume outstanding
SARs. The foregoing notwithstanding, no modification of an SAR shall, without the consent of the Optionee, alter or impair his or her rights or obligations
under such SAR. Notwithstanding anything in this Plan to the contrary, and except for the adjustments provided in Articles 10 and 11, neither the Committee
nor any other person may (a) decrease the exercise price for any outstanding SAR after the date of grant, (b) cancel or allow an Optionee to surrender an
outstanding SAR to the Corporation in exchange for cash or as consideration for the grant of a new SAR with a lower exercise price or the grant of another
type of Award the effect of which is to reduce the exercise price of any outstanding SAR or (c) take any other action with respect to a SAR that would be
treated as a repricing under the rules and regulations of the NASDAQ Stock Market (or such other principal U.S. national securities exchange on which the
Corporation’s Common Stock is traded).
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ARTICLE VIII. RESTRICTED SHARES.
8.1 Restricted Stock Agreement. Each grant of Restricted Shares under the Plan shall be evidenced by a Restricted Stock Agreement between
the recipient and the Corporation. Such Restricted Shares shall be subject to all applicable terms of the Plan and may be subject to any other terms that are
not inconsistent with the Plan. The provisions of the various Restricted Stock Agreements entered into under the Plan need not be identical.
8.2 Payment for Awards. Subject to the following two sentences, Restricted Shares may be sold or awarded under the Plan for such
consideration as the Committee may determine, including (without limitation) cash, cash equivalents, property, full-recourse promissory notes, past services
and future services. To the extent that an Award consists of newly issued Restricted Shares, the consideration shall consist exclusively of cash, cash
equivalents, property or past services rendered to the Corporation (or a Parent or Subsidiary) or, for the amount in excess of the par value of such newly
issued Restricted Shares, full-recourse promissory notes. If the Participant is an Outside Director or executive officer of the Corporation, he or she may pay
for Restricted Shares with a promissory note only to the extent permitted by section 13(k) of the Exchange Act. Within the limitations of the Plan, the
Committee may accept the cancellation of outstanding options in return for the grant of Restricted Shares.
8.3 Vesting Conditions. Each Award of Restricted Shares may or may not be subject to vesting. Vesting shall occur, in full or in installments,
upon satisfaction of the conditions specified in the Restricted Stock Agreement. The Committee may include among such conditions the requirement that the
performance of the Corporation or a business unit of the Corporation for a specified period of one or more fiscal years equal or exceed a target determined in
advance by the Committee. The Committee shall determine such performance. Such target shall be based on one or more of the criteria set forth in
Appendix A. The Committee shall identify such target not later than the 90 day of such period. Subject to adjustment in accordance with Article 11, in no
event shall more than 1,500,000 Restricted Shares that are subject to performance-based vesting conditions be granted to any Participant in a single fiscal year
of the Corporation, except that 2,000,000 Restricted Shares may be granted to a new Employee in the fiscal year of the Corporation in which his or her
service as an Employee first commences. A Restricted Stock Agreement may provide for accelerated vesting in the event of a Change in Control, the
Participant’s death, disability or retirement or other events.
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8.4 Voting and Dividend Rights. The holders of Restricted Shares awarded under the Plan shall have the same voting, dividend and other
rights as the Corporation’s other stockholders. A Restricted Stock Agreement, however, may require that the holders of Restricted Shares invest any cash
dividends received in additional Restricted Shares. Such additional Restricted Shares shall be subject to the same conditions and restrictions as the Award
with respect to which the dividends were paid. Cash dividends with respect to any Restricted Shares and any other property (other than cash) distributed as a
dividend or otherwise with respect to Restricted Shares that vest based on the achievement of performance goals shall be accumulated, shall be subject to
restrictions and risk of forfeiture to the same extent as the Restricted Shares with respect to which such cash, shares or other property has been distributed and
shall be paid at the time such restrictions and risk of forfeiture lapse.
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ARTICLE IX. STOCK UNITS AND PERFORMANCE CASH AWARDS.
9.1 Stock Unit Agreement. Each grant of Stock Units under the Plan shall be evidenced by a Stock Unit Agreement between the recipient and
the Corporation. Such Stock Units shall be subject to all applicable terms of the Plan and may be subject to any other terms that are not inconsistent with the
Plan. The provisions of the various Stock Unit Agreements entered into under the Plan need not be identical. Stock Units may be granted in consideration of
a reduction in the recipient’s other compensation.
9.2 Payment for Awards. To the extent that an Award is granted in the form of Stock Units, no cash consideration shall be required of the
Award recipients.
9.3 Vesting Conditions. Each Award of Stock Units may or may not be subject to vesting. Vesting shall occur, in full or in installments, upon
satisfaction of the conditions specified in the Stock Unit Agreement. The Committee may include among such conditions the requirement that the
performance of the Corporation or a business unit of the Corporation for a specified period of one or more fiscal years equal or exceed a target determined in
advance by the Committee. The Committee shall determine such performance. Such target shall be based on one or more of the criteria set forth in
Appendix A. The Committee shall identify such target not later than the 90 day of such period. Subject to adjustment in accordance with Article 11, in no
event shall more than 1,500,000 Stock Units that are subject to performance-based vesting conditions be granted to any Participant in a single fiscal year of
the Corporation, except that up to 2,000,000 Stock Units subject to performance-based vesting conditions may be granted to a new Employee in the fiscal
year of the Corporation in which his or her Service first commences. A Stock Unit Agreement may provide for accelerated vesting in the event of a Change
in Control, the Participant’s death, disability or retirement or other events.
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9.4 Voting and Dividend Rights. The holders of Stock Units shall have no voting rights. Prior to settlement or forfeiture, any Stock Unit
awarded under the Plan may, at the Committee’s discretion, carry with it a right to dividend equivalents. Such right entitles the holder to be credited with an
amount equal to all cash dividends paid on one share of Common Stock while the Stock Unit is outstanding. Dividend equivalents may be converted into
additional Stock Units. Settlement of dividend equivalents may be made in the form of cash, in the form of shares of Common Stock, or in a combination of
both. Prior to distribution, any dividend equivalents which are not paid shall be subject to the same conditions and restrictions as the Stock Units to which
they attach. Notwithstanding the foregoing, dividend equivalents with respect to any Stock Units that vest based on the achievement of performance goals
shall be subject to the same conditions and restrictions as the Stock Units to which they attach.
9.5 Form and Time of Settlement of Stock Units. Settlement of vested Stock Units may be made in the form of (a) cash, (b) shares of
Common Stock or (c) any combination of both, as determined by the Committee. The actual number of Stock Units eligible for settlement may be larger or
smaller than the number included in the original Award, based on predetermined performance factors. Methods of converting Stock Units into cash may
include (without limitation) a method based on the average Fair Market Value of shares of Common Stock over a series of trading days. Vested Stock Units
may be settled in a lump sum or in installments. The distribution may occur or commence when all vesting conditions applicable to
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the Stock Units have been satisfied or have lapsed, or it may be deferred to any later date. The amount of a deferred distribution may be increased by an
interest factor or by dividend equivalents. Until an Award of Stock Units is settled, the number of such Stock Units shall be subject to adjustment pursuant to
Article 11.
9.6 Death of Recipient. Any Stock Units Award that becomes payable after the recipient’s death shall be distributed to the recipient’s
beneficiary or beneficiaries. Each recipient of a Stock Units Award under the Plan shall designate one or more beneficiaries for this purpose by filing the
prescribed form with the Corporation. A beneficiary designation may be changed by filing the prescribed form with the Corporation at any time before the
Award recipient’s death. If no beneficiary was designated or if no designated beneficiary survives the Award recipient, then any Stock Units Award that
becomes payable after the recipient’s death shall be distributed to the recipient’s estate.
9.7 Creditors’ Rights. A holder of Stock Units shall have no rights other than those of a general creditor of the Corporation. Stock Units
represent an unfunded and unsecured obligation of the Corporation, subject to the terms and conditions of the applicable Stock Unit Agreement.
9.8 Performance Cash Awards. A Performance Cash Award is a cash award that may be granted upon the attainment of certain performance
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goals for a specified performance period of one or more fiscal years. The Committee shall determine such performance. The goals applicable to a
Performance Cash Award shall be based on one or more of the criteria set forth in Appendix A. The Committee shall determine such goals no later than the
90 day of such period. Each Performance Cash Award shall be set forth in a written agreement or in a resolution duly adopted by the Committee which shall
contain provisions determined by the Committee and not inconsistent with the Plan. The terms of various Performance Cash Awards need not be identical.
The maximum amount that may be paid to any Participant for each fiscal year of the Corporation in a performance period attributable to Performance Cash
Awards shall not exceed $2,000,000. The Committee may determine, at the time of granting a Performance Cash Award or thereafter, that all or part of such
Performance Cash Award shall become earned and payable in the event that the Corporation is subject to a Change in Control before the Participant’s service
terminates or as otherwise determined by the Committee in special circumstances.
ARTICLE X. CHANGE IN CONTROL.
10.1 Effect of Change in Control. Unless the Committee provides otherwise in a Stock Option Agreement, SAR Agreement, Restricted Stock
Agreement or Stock Unit Agreement, in the event of any Change in Control, each outstanding Stock Award shall automatically accelerate so that each such
Stock Award shall, immediately prior to the effective date of the Change in Control, become fully exercisable for all of the shares of Common Stock at the
time subject to such Stock Award and may be exercised for any or all of those shares as fully-vested shares of Common Stock. However, an outstanding
Stock Award shall not so accelerate if and to the extent such Stock Award is, in connection with the Change in Control, either to be assumed by the successor
corporation (or parent thereof) or to be replaced with a comparable Stock Award for shares of the capital stock of the successor corporation (or parent
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thereof). The determination of award comparability shall be made by the Committee, and its determination shall be final, binding and conclusive.
10.2 Acceleration. The Committee shall have the discretion, exercisable either at the time the Stock Award is granted or at any time while the
Stock Award remains outstanding, to provide for the automatic acceleration of vesting upon the occurrence of a Change in Control, whether or not the Stock
Award is to be assumed or replaced in the Change in Control.
ARTICLE XI. PROTECTION AGAINST DILUTION.
11.1 Adjustments. In the event of a subdivision of the outstanding shares of Common Stock, a declaration of a dividend payable in shares of
Common Stock, a declaration of a dividend payable in a form other than shares of Common Stock in an amount that has a material affect on the price of
shares of Common Stock, a combination or consolidation of the outstanding shares of Common Stock (by reclassification or otherwise) into a lesser number
of shares of Common Stock, a recapitalization, a spin-off or a similar occurrence, corresponding adjustments shall automatically be made in each of the
following:
(a) The number of Options, SARs, Restricted Shares and Stock Units available for future Stock Awards under Article 3, including the
limitation on the number of ISOs in Section 3.1;
(b) The limitations set forth in Sections 5.2, 7.2, 8.3 and 9.3;
(c) The number of shares of Common Stock covered by each outstanding Option and SAR;
(d) The Exercise Price under each outstanding Option and SAR; or
(e) The number of Stock Units included in any prior Award which has not yet been settled.
Except as provided in this Article 11, a Participant shall have no rights by reason of any issue by the Corporation of stock of any class or securities
convertible into stock of any class, any subdivision or consolidation of shares of stock of any class, the payment of any stock dividend or any other increase or
decrease in the number of shares of stock of any class.
11.2 Dissolution or Liquidation. To the extent not previously exercised or settled, Options, SARs and Stock Units shall terminate immediately
prior to the dissolution or liquidation of the Corporation.
11.3 Reorganizations. In the event that the Corporation is a party to a merger or consolidation, all outstanding Stock Awards shall be subject to
the agreement of merger or consolidation. Such agreement shall provide for one or more of the following:
(a) The continuation of such outstanding Stock Awards by the Corporation (if the Corporation is the surviving corporation).
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(b) The assumption of such outstanding Stock Awards by the surviving corporation or its parent (in a manner that complies with
section 424(a) of the Code with respect to Options).
(c) The substitution by the surviving corporation or its parent of new awards for such outstanding Stock Awards (in a manner that
complies with section 424(a) of the Code with respect to Options).
(d) Full exercisability of such outstanding Stock Awards and full vesting of the shares of Common Stock subject to such Stock
Awards, followed by the cancellation of such Stock Awards. The full exercisability of such Stock Awards and full vesting of the shares of Common Stock
subject to such Stock Awards may be contingent on the closing of such merger or consolidation. The Participants shall be able to exercise such Stock Awards
during a period of not less than five full business days preceding the closing date of such merger or consolidation, unless (i) a shorter period is required to
permit a timely closing of such merger or consolidation and (ii) such shorter period still offers the Participants a reasonable opportunity to exercise such Stock
Awards. Any exercise of such Stock Awards during such period may be contingent on the closing of such merger or consolidation.
(e) The cancellation of such outstanding Stock Awards and a payment to the Participants equal to the excess of (i) the Fair Market
Value of the shares of Common Stock subject to such Stock Awards (whether or not such Stock Awards are then exercisable or such shares of Common Stock
are then vested) as of the closing date of such merger or consolidation over (ii) their Exercise Price. Such payment shall be made in the form of cash, cash
equivalents, or securities of the surviving corporation or its parent with a Fair Market Value equal to the required amount. Such payment may be made in
installments and may be deferred until the date or dates when such Stock Awards would have become exercisable or such shares of Common Stock would
have vested. Such payment may be subject to vesting based on the Optionee’s continuing service, provided that the vesting schedule shall not be less
favorable to the Participants than the schedule under which such Stock Awards would have become exercisable or such shares of Common Stock would have
vested. If the Exercise Price of the shares of Common Stock subject to such Stock Awards exceeds the Fair Market Value of such shares of Common Stock,
then such Stock Awards may be cancelled without making a payment to the Participants. For purposes of this Subsection (e), the Fair Market Value of any
security shall be determined without regard to any vesting conditions that may apply to such security.
ARTICLE XII. DEFERRAL OF AWARDS.
The Committee (in its sole discretion) may permit or require a Participant to:
(a) Have cash that otherwise would be paid to such Participant as a result of the exercise of an SAR or the settlement of Stock Units
credited to a deferred compensation account established for such Participant by the Committee as an entry on the Corporation’s books;
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(b) Have shares of Common Stock that otherwise would be delivered to such Participant as a result of the exercise of an Option or
SAR converted into an equal number of Stock Units; or
(c) Have shares of Common Stock that otherwise would be delivered to such Participant as a result of the exercise of an Option or
SAR or the settlement of Stock Units converted into amounts credited to a deferred compensation account established for such Participant by the Committee
as an entry on the Corporation’s books. Such amounts shall be determined by reference to the Fair Market Value of such shares of Common Stock as of the
date they otherwise would have been delivered to such Participant.
A deferred compensation account established under this Article 12 may be credited with interest or other forms of investment return, as determined by the
Committee. A Participant for whom such an account is established shall have no rights other than those of a general creditor of the Corporation. Such an
account shall represent an unfunded and unsecured obligation of the Corporation and shall be subject to the terms and conditions of the applicable agreement
between such Participant and the Corporation. If the deferral or conversion of Awards is permitted or required, the Committee (in its sole discretion) may
establish rules, procedures and forms pertaining to such Awards, including (without limitation) the settlement of deferred compensation accounts established
under this Article 12.
ARTICLE XIII. AWARDS UNDER OTHER PLANS.
The Corporation may grant awards under other plans or programs. Such awards may be settled in the form of shares of Common Stock issued under
this Plan. Such shares of Common Stock shall be treated for all purposes under the Plan like shares of Common Stock issued in settlement of Stock Units and
shall, when issued, reduce the number of shares of Common Stock available under Article 3.
ARTICLE XIV. PAYMENT OF FEES IN SECURITIES.
14.1 Effective Date. No provision of this Article 14 shall be effective unless and until the Board has determined to implement such provision.
14.2 Elections to Receive NSOs, Restricted Shares or Stock Units. An Outside Director may elect to receive his or her annual retainer
payments or meeting fees from the Corporation in the form of cash, NSOs, Restricted Shares or Stock Units, or a combination thereof, as determined by the
Board. Such NSOs, Restricted Shares and Stock Units shall be issued under the Plan. An election under this Article 14 shall be filed with the Corporation on
the prescribed form.
14.3 Number and Terms of NSOs, Restricted Shares or Stock Units. The number of NSOs, Restricted Shares or Stock Units to be granted to
Outside Directors in lieu of annual retainers or meeting fees that would otherwise be paid in cash shall be calculated in a manner determined by the Board.
The Board shall also determine the terms of such NSOs, Restricted Shares or Stock Units.
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ARTICLE XV. LIMITATION ON RIGHTS.
15.1 Retention Rights. Neither the Plan nor any Award granted under the Plan shall be deemed to give any individual a right to remain an
Employee, Outside Director or Consultant. The Corporation and its Parents, Subsidiaries and Affiliates reserve the right to terminate the service of any
Employee, Outside Director or Consultant at any time, with or without cause, subject to applicable laws, the Corporation’s certificate of incorporation and by-
laws and a written employment agreement (if any).
15.2 Stockholders’ Rights. A Participant shall have no dividend rights, voting rights or other rights as a stockholder with respect to any shares
of Common Stock covered by his or her Award prior to the time a stock certificate for such shares of Common Stock is issued or, if applicable, the time he or
she becomes entitled to receive such shares of Common Stock by filing any required notice of exercise and paying any required Exercise Price. No
adjustment shall be made for cash dividends or other rights for which the record date is prior to such time, except as expressly provided in the Plan.
15.3 Regulatory Requirements. Any other provision of the Plan notwithstanding, the obligation of the Corporation to issue shares of Common
Stock under the Plan shall be subject to all applicable laws, rules and regulations and such approval by any regulatory body as may be required. The
Corporation reserves the right to restrict, in whole or in part, the delivery of shares of Common Stock pursuant to any Award prior to the satisfaction of all
legal requirements relating to the issuance of such shares of Common Stock, to their registration, qualification or listing or to an exemption from registration,
qualification or listing.
15.4 Transferability of Awards. Except as provided below, no Award and no shares subject to Awards that have not been issued or as to which
any applicable restriction, performance or deferral period has not lapsed, may be sold, assigned, transferred, pledged or otherwise encumbered, other than by
a beneficiary designation, will or the laws of descent and distribution, and such Award may be exercised during the life of a Participant only by the Participant
or the Participant’s guardian or legal representative. To the extent and under such terms and conditions as determined by the Committee, a Participant may
assign or transfer an Award (each transferee there, a “Permitted Assignee”) other than an ISO to a “family member” as such term is defined in the General
Instructions to Form S-8 (whether by gift or a domestic relations order); provided that such Permitted Assignee shall be bound by and subject to all of the
terms and conditions of the Plan and the Award Agreement relating to the transferred Award and shall execute an agreement satisfactory to the Corporation
evidencing such obligations; and provided further that such Participant shall remain bound by the terms and conditions of the Plan.
ARTICLE XVI. WITHHOLDING TAXES.
16.1 General. To the extent required by applicable federal, state, local or foreign law, a Participant or his or her successor shall make
arrangements satisfactory to the Corporation for the satisfaction of any withholding tax obligations that arise in connection with the Plan. The Corporation
shall not be required to issue any shares of Common Stock or make any cash payment under the Plan until such obligations are satisfied.
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16.2 Share Withholding. To the extent that applicable law subjects a Participant to tax withholding obligations, the Committee may permit a
Participant to satisfy all or part of his or her withholding or income tax obligations by having the Corporation withhold all or a portion of any shares of
Common Stock that otherwise would be issued to him or her or by surrendering all or a portion of any shares of Common Stock that he or she previously
acquired. Such shares of Common Stock shall be valued at their Fair Market Value on the date they are withheld or surrendered.
ARTICLE XVII. FUTURE OF THE PLAN.
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17.1 Term of the Plan. The Plan shall remain in effect until it is terminated under Section 17.2, except that no ISOs shall be granted on or after
the 10 anniversary of the later of (a) the date the Board adopted the Plan or (b) the date the Board adopted the most recent increase in the number of shares
of Common Stock available under Article 3 which was approved by the Corporation’s stockholders. No further option grants shall be made under the Pre-
IPO Plans after the Plan effective date. No further awards shall be made under the Corporation’s 2008 New Employee Equity Incentive Plan after the date of
the Corporation’s 2010 Annual Meeting of Stockholders, assuming this Plan is re-approved by the stockholders at such meeting. All awards outstanding
under the Predecessor Plans as of such dates shall, immediately upon effectiveness of the Plan, remain outstanding in accordance with their terms. Each
outstanding award under the Predecessor Plans shall continue to be governed solely by the terms of the documents evidencing such award, and no provision
of the Plan shall be deemed to affect or otherwise modify the rights or obligations of the holders of such awards with respect to their acquisition of shares of
Common Stock, except that the following vesting acceleration provisions relating to Change in Control shall be extended to the options outstanding under the
Pre-IPO Plans at the IPO: if the optionee experiences an involuntary termination within three months before or twenty-four months following a Change in
Control, each of such optionee’s outstanding options shall automatically accelerate so that each such option shall, immediately prior to the effective date of
the termination, become fully exercisable for all of the shares of Common Stock at the time subject to such option and may be exercised for any or all of those
shares as fully-vested shares of Common Stock.
17.2 Amendment or Termination. The Board may, at any time and for any reason, amend or terminate the Plan. No Awards shall be granted
under the Plan after the termination thereof. The termination of the Plan, or any amendment thereof, shall not affect any Award previously granted under the
Plan.
17.3 Stockholder Approval. An amendment of the Plan shall be subject to the approval of the Corporation’s stockholders only to the extent
required by applicable laws, regulations or rules. However, an amendment of the last sentence of Section 5.5 or 7.6 is subject to the approval of the
Corporation’s stockholders and section 162(m) of the Code may require that the Corporation’s stockholders approve:
(a) The Plan not later than the first regular meeting of stockholders that occurs in the fourth calendar year following the calendar year
in which the Corporation’s initial public offering occurred; and
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(b) The performance criteria set forth on Appendix A not later than the first meeting of stockholders that occurs in the fifth year
following the year in which the Corporation’s stockholders previously approved such criteria.
ARTICLE XVIII. DEFINITIONS.
18.1 “Affiliate” means any entity other than a Subsidiary, if the Corporation and/or one or more Subsidiaries own not less than 50% of such
entity.
18.2 “Award” means any award of a Stock Award or a Performance Cash Award under the Plan.
18.3 “Board” means the Corporation’s Board of Directors, as constituted from time to time.
18.4 “Change in Control” shall mean:
(a) The consummation of a merger or consolidation of the Corporation with or into another entity or any other corporate
reorganization, if persons who were not stockholders of the Corporation immediately prior to such merger, consolidation or other reorganization own
immediately after such merger, consolidation or other reorganization 50% or more of the voting power of the outstanding securities of each of (i) the
continuing or surviving entity and (ii) any direct or indirect parent corporation of such continuing or surviving entity;
(b) The sale, transfer or other disposition of all or substantially all of the Corporation’s assets;
(c) A change in the composition of the Board, as a result of which fewer than 50% of the incumbent directors are directors who either:
Board (the “Original Directors”) or
(i) Had been directors of the Corporation on the date 24 months prior to the date of such change in the composition of the
(ii) Were appointed to the Board, or nominated for election to the Board, with the affirmative votes of at least a majority of
the aggregate of (A) the Original Directors who were in office at the time of their appointment or nomination and (B) the directors whose appointment or
nomination was previously approved in a manner consistent with this Paragraph (ii); or
(d) Any transaction as a result of which any person is the “beneficial owner” (as defined in Rule 13d-3 under the Exchange Act),
directly or indirectly, of securities of the Corporation representing at least 50% of the total voting power represented by the Corporation’s then outstanding
voting securities. For purposes of this Paragraph (d), the term “person” shall have the same meaning as when used in sections 13(d) and 14(d) of the
Exchange Act but shall exclude (i) a trustee or other fiduciary holding securities under an employee benefit plan of the Corporation or of a Parent or
Subsidiary and (ii) a corporation owned directly or indirectly by the stockholders of the Corporation in substantially the same proportions as their ownership
of the common stock of the Corporation.
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Except with respect to a GSK Change In Control (defined below), (i) any stock purchase by SmithKline Beecham Corporation, a Pennsylvania corporation
(“GSK”), pursuant to the Class A Common Stock Purchase Agreement dated as of March 30, 2004 or (ii) the exercise by GSK of any of its rights under the
Amended and Restated Governance Agreement dated as of June 4, 2004 among the Corporation, GSK, GlaxoSmithKline plc and Glaxo Group Limited, as
amended (the “Governance Agreement”) to representation on the Board (and its committees) or (iii) any acquisition by GSK of securities of the Corporation
(whether by merger, tender offer, private or market purchases or otherwise) not prohibited by the Governance Agreement shall not constitute a Change in
Control. A transaction shall not constitute a Change in Control if its sole purpose is to change the state of the Corporation’s incorporation or to create a
holding company that will be owned in substantially the same proportions by the persons who held the Corporation’s securities immediately before such
transaction. A “GSK Change In Control” shall mean the acquisition by GSK of the Corporation’s Voting Stock (as defined in the Governance Agreement) that
would bring GSK’s Percentage Interest (as defined in the Governance Agreement) to 100% in compliance with the provisions of the Governance Agreement.
18.5 “Code” means the Internal Revenue Code of 1986, as amended.
18.6 “Committee” means a committee of the Board, as described in Article 2.
18.7 “Common Stock” means the common stock of the Corporation.
18.8 “Corporation” means Theravance, Inc., a Delaware corporation.
18.9 “Consultant” means a consultant or adviser who provides bona fide services to the Corporation, a Parent, a Subsidiary or an Affiliate as an
independent contractor. Service as a Consultant shall be considered employment for all purposes of the Plan, except as provided in Section 4.1.
18.10 “Employee” means a common-law employee of the Corporation, a Parent, a Subsidiary or an Affiliate.
18.11 “Exchange Act” means the Securities Exchange Act of 1934, as amended.
18.12 “Exercise Price,” in the case of an Option, means the amount for which one share of Common Stock may be purchased upon exercise of
such Option, as specified in the applicable Stock Option Agreement. “Exercise Price,” in the case of an SAR, means an amount, as specified in the applicable
SAR Agreement, which is subtracted from the Fair Market Value of one share of Common Stock in determining the amount payable upon exercise of such
SAR.
18.13 “Fair Market Value” means the closing selling price of one share of Common Stock as reported on Nasdaq, and if not available, then it
shall be determined by the Committee in good faith on such basis as it deems appropriate. Whenever possible, the determination of Fair Market Value by the
Committee shall be based on the prices reported in The Wall Street Journal. Such determination shall be conclusive and binding on all persons.
18.14 “IPO” means the initial public offering of the Corporation’s Common Stock.
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18.15 “ISO” means an incentive stock option described in section 422(b) of the Code.
18.16 “NSO” means a stock option not described in sections 422 or 423 of the Code.
18.17 “Option” means an ISO or NSO granted under the Plan and entitling the holder to purchase shares of Common Stock.
18.18 “Optionee” means an individual who or estate that holds an Option or SAR.
18.19 “Outside Director” shall mean a member of the Board who is not an Employee. Service as an Outside Director shall be considered
employment for all purposes of the Plan, except as provided in Section 4.1.
18.20 “Parent” means any corporation (other than the Corporation) in an unbroken chain of corporations ending with the Corporation, if each of
the corporations other than the Corporation owns stock possessing 50% or more of the total combined voting power of all classes of stock in one of the other
corporations in such chain. A corporation that attains the status of a Parent on a date after the adoption of the Plan shall be considered a Parent commencing
as of such date.
18.21 “Participant” means an individual who or estate that holds an Award.
18.22 “Performance Cash Award” means an award of cash granted under Section 9.8 of the Plan.
18.23 “Plan” means this Theravance, Inc. 2004 Equity Incentive Plan, as amended from time to time.
18.24 “Predecessor Plans” means the Corporation’s 1997 Stock Plan, Long-Term Stock Option Plan and 2008 New Employee Equity Incentive
Plan.
18.25 “Pre-IPO Plans” means the Corporation’s 1997 Stock Plan and Long-Term Stock Option Plan.
18.26 “Restricted Share” means a share of Common Stock awarded under Article 8 of the Plan.
18.27 “Restricted Stock Agreement” means the agreement between the Corporation and the recipient of a Restricted Share that contains the
terms, conditions and restrictions pertaining to such Restricted Share.
18.28 “SAR” means a stock appreciation right granted under the Plan.
18.29 “SAR Agreement” means the agreement between the Corporation and an Optionee which contains the terms, conditions and restrictions
pertaining to his or her SAR.
18.30 “Stock Award” means any award of an Option, an SAR, a Restricted Share or a Stock Unit under the Plan.
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18.31 “Stock Option Agreement” means the agreement between the Corporation and an Optionee that contains the terms, conditions and
restrictions pertaining to his or her Option.
18.32 “Stock Unit” means a bookkeeping entry representing the equivalent of one share of Common Stock, as awarded under the Plan.
18.33 “Stock Unit Agreement” means the agreement between the Corporation and the recipient of a Stock Unit which contains the terms,
conditions and restrictions pertaining to such Stock Unit.
18.34 “Subsidiary” means any corporation (other than the Corporation) in an unbroken chain of corporations beginning with the Corporation, if
each of the corporations other than the last corporation in the unbroken chain owns stock possessing 50% or more of the total combined voting power of all
classes of stock in one of the other corporations in such chain. A corporation that attains the status of a Subsidiary on a date after the adoption of the Plan
shall be considered a Subsidiary commencing as of such date.
18.35 “Substitute Awards” means Awards or shares of Common Stock issued by the Corporation in assumption of, or substitution or exchange
for, Awards previously granted, or the right or obligation to make future awards, in each case by a corporation acquired by the Corporation or any Affiliate or
with which the Corporation or any Affiliates combines to the extent permitted by NASDAQ Marketplace Rule 5635 or any successor thereto.
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Appendix A
PERFORMANCE CRITERIA
FOR RESTRICTED SHARES, STOCK UNITS AND PERFORMANCE CASH AWARDS
The performance goals that may be used by the Committee for such awards shall consist of: stock price; net sales; revenue; revenue growth or product
revenue growth; operating income (before or after taxes); pre- or after-tax income or loss (before or after allocation of corporate overhead and bonus);
earnings or loss per share; net income or loss (before or after taxes); return on equity; total stockholder return; return on assets or net assets; appreciation in
and/or maintenance of the price of the Shares or any other publicly-traded securities of the Corporation; market share; gross profits; net profits; earnings or
losses (including earnings or losses before taxes, before interest and taxes, or before interest, taxes, depreciation and amortization); economic value-added
models or equivalent metrics; comparisons with various stock market indices; reductions in costs; cash flow or cash flow per share (before or after dividends);
return on capital (including return on total capital or return on invested capital); cash flow return on investment; improvement in or attainment of expense
levels or working capital levels, including cash, inventory and accounts receivable; operating margin; gross margin; year-end cash; cash margin; debt
reduction; stockholders equity; operating efficiencies; market share; customer satisfaction; customer growth; employee satisfaction; drug development
milestones; regulatory achievements (including submitting or filing applications or other documents with regulatory authorities, successfully executing an
advisory committee meeting, or receiving approval of any such applications or other documents and passing pre-approval inspections (whether of the
Corporation or the Corporation’s third-party manufacturer) and validation of manufacturing processes (whether the Corporation’s or the Corporation’s third-
party manufacturer’s); initiation or completion of pre-clinical studies; clinical achievements (including initiating clinical studies; initiating enrollment,
completing enrollment or enrolling particular numbers of subjects in clinical studies; completing phases of a clinical study (including the treatment phase); or
announcing or presenting preliminary or final data from clinical studies; in each case, whether on particular timelines or generally); strategic partnerships or
transactions (including in-licensing and out-licensing of intellectual property; establishing relationships with commercial entities with respect to the
marketing, distribution and sale of the Corporation’s products or development candidates (including with group purchasing organizations, distributors and
other vendors); supply chain achievements (including establishing relationships with manufacturers or suppliers of component materials and manufacturers of
the Corporation’s products or development candidates); co-development, co-marketing, profit sharing, joint venture or other similar arrangements); financial
ratios, including those measuring liquidity, activity, profitability or leverage; cost of capital or assets under management; financing and other capital raising
transactions (including sales of the Corporation’s equity or debt securities; factoring transactions; sales or licenses of the Corporation’s assets, including its
intellectual property, whether in a particular jurisdiction or territory or globally; or through partnering transactions); implementation, completion or attainment
of measurable objectives with respect to research (including nominating a development candidate or initiating a new full discovery program), development,
manufacturing (including initiating formulation or device development work or finalizing API or drug product processes), commercialization, development
candidates, products
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or projects, safety, production volume levels, acquisitions and divestitures; factoring transactions; and recruiting and maintaining personnel. In the areas of
development, regulatory progress and commercialization, the achievements described above performed by a third party with which the Corporation has a
licensing or collaborative agreement (a “Partner”) shall apply to the Corporation. For example, if a Partner accomplishes development milestones, regulatory
achievements, commercialization or sales targets with an asset within a program that is a subject of the licensing or collaboration agreement between the
Corporation and the Partner, then such Partner’s accomplishments shall constitute achievements of the Corporation. Such performance goals also may be
based solely by reference to the Corporation’s performance or the performance of a Subsidiary, division, business segment or business unit of the Corporation,
or based upon the relative performance of other companies or upon comparisons of any of the indicators of performance relative to other companies. To the
extent consistent with section 162(m) of the Code, the Committee may adjust the results under any performance criterion to exclude any of the following
events that occurs during a performance measurement period: (a) asset write-downs, (b) litigation, claims, judgments or settlements, (c) the effect of changes
in tax law, accounting principles or other such laws or provisions affecting reported results, (d) accruals for reorganization and restructuring programs and
(e) any extraordinary, unusual or non-recurring items.
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Form of Notice of Grant and Stock Option Agreement under 2004 Equity Incentive Plan
THERAVANCE, INC. 2004 EQUITY INCENTIVE PLAN
NOTICE OF STOCK OPTION GRANT
You have been granted the following option to purchase shares of the Common Stock of Theravance, Inc. (the “Company”):
Name of Optionee:
«First» «Last»
ID Number:
«ID»
Total Number of Shares:
«Shares»
Type of Option:
Grant Number:
Nonstatutory Stock Option
«Number»
Exercise Price Per Share:
«Price»
Date of Grant:
February 10, 2005
Vesting Schedule:
This option becomes exercisable for the first time on the earlier of the Put Date or January 1, 2008 (as applicable, the
“First Exercise Date”) provided you have remained in continuous Service from the Date of Grant through the First
Exercise Date. On the First Exercise Date, this option may be exercised and shall be vested as to that number of
Shares subject to the option equal to 1/48 times the number of months that have elapsed from the Date of Grant
through the First Exercise Date. Thereafter, this option may be exercised and shall be vested as to an additional
1/48 of the Shares subject to this option when you complete each month of continuous Service following the First
Exercise Date. The option shall be fully vested and exercisable on the 4-year anniversary of the Date of
Grant provided you have remained in continuous Service through such date.
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Expiration Date:
February 9, 2015. This option expires earlier if your Service terminates earlier, as described in the Stock Option
Agreement.
You and the Company agree that this option is granted under and governed by the terms and conditions of the Stock Option Agreement, which is attached to
and made a part of this document, and the 2004 Equity Incentive Plan (the “Plan”).
You further agree that the Company may deliver by email all documents relating to the Plan or this option (including, without limitation, prospectuses
required by the Securities and Exchange Commission) and all other documents that the Company is required to deliver to its security holders (including,
without limitation, annual reports and proxy statements). You also agree that the Company may deliver these documents by posting them on a web site
maintained by the Company or by a third party under contract with the Company. If the Company posts these documents on a web site, it will notify you by
email.
THERAVANCE, INC. 2004 EQUITY INCENTIVE PLAN
STOCK OPTION AGREEMENT
Tax Treatment
This option is a nonstatutory stock option.
Vesting
This option becomes exercisable in installments, as shown in the Notice of Stock Option Grant.
This option shall become exercisable in full if not assumed or a new option substituted pursuant to Section 11.3 of the
Plan. In addition, this option becomes exercisable in full if the Company is subject to a “Change in Control” (as
defined in the Plan) before your Service terminates, and you are subject to an Involuntary Termination (as defined
below) within three months prior or 24 months after the Change in Control. Should the exercisability of this option
accelerate as a result of the occurrence of a Change in Control prior to the First Exercise Date, the right to exercise
this option shall be deferred as to the additional shares until the First Exercise Date, provided and only if this option is
assumed by the surviving corporation or its parent or the surviving corporation or its parent substitutes its own option
for this option.
For purposes of this Agreement, “Cause” shall mean (i) the unauthorized use or disclosure of the confidential
information or trade secrets of the Company, which use causes material harm to the Company, (ii) conviction of a
felony under the laws of the United States or any state thereof, (iii) gross negligence or (iv) repeated failure to
perform lawful assigned duties for thirty days after receiving written notification from the Board of Directors.
For purposes of this Agreement, “Involuntary Termination” means the termination of your Service by reason of:
(a) an involuntary dismissal or discharge by the Company for reasons other than for Cause; or
(b) your voluntary resignation following (i) a change in your position with the Company (or Parent or Subsidiary
employing you) which materially reduces your level of responsibility, (ii) a reduction in your level of
compensation (including base salary, fringe benefits and participation in corporate-performance based bonus
or incentive programs) or (iii) a relocation of your workplace more than fifty miles away from the workplace
designated by the Company on your initial date of service,
provided and only if such change, reduction or relocation is effected by the Company without your consent.
For purposes of this Agreement, “Put Date” shall mean the day after the final day of the Put Period, as such term is
defined in the Restated Certificate of Incorporation of Theravance, Inc. or, if earlier, the consummation of a Qualified
Change in Control as defined in the Restated Certificate of Incorporation of Theravance, Inc.
For purposes of this Agreement, “Service” means your service as an Employee, Outside Director or Consultant.
No additional shares will vest after your Service has terminated for any reason, except to the extent set forth above if
you are subject to an Involuntary Termination within three months prior to a Change in Control.
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This option expires in any event at the close of business at Company headquarters on the day before the
10 anniversary of the Date of Grant, as shown in the Notice of Stock Option Grant. (It will expire earlier if your
Service terminates, as described below.) You may exercise this option at any time before its expiration under the
preceding sentence, but only to the extent that this option had become exercisable before your Service terminated
(giving effect where necessary to any deferred acceleration on Change in Control as set forth under the heading
“Vesting” above).
Term
Regular Termination
If your Service terminates for any reason except death or total and permanent disability, then this option will expire at
the close of business at Company headquarters on the date three months after the later of your termination date or the
First Exercise Date. The Company determines when your Service terminates for this purpose.
Death
Disability
If you die before your Service terminates, then this option will expire at the close of business at Company
headquarters on the later of the date that is three months after the First Exercise Date or 12 months after the date of
death.
If your Service terminates because of your total and permanent disability, then this option will expire at the close of
business at Company headquarters on the date 12 months after your termination date.
For all purposes under this Agreement, “total and permanent disability” means that you are unable to engage in any
substantial gainful activity by reason of any medically determinable physical or mental impairment which can be
expected to result in death or which has lasted, or can be
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expected to last, for a continuous period of not less than one year.
Leaves of Absence and Part-
Time Work
For purposes of this option, your Service does not terminate when you go on a military leave, a sick leave or another
bona fide leave of absence, if the leave was approved by the Company in writing. But your Service terminates when
the approved leave ends, unless you immediately return to active work.
If you go on a leave of absence, then the vesting schedule specified in the Notice of Stock Option Grant may be
adjusted in accordance with the Company’s leave of absence policy or the terms of your leave. If you commence
working on a part-time basis, then the vesting schedule specified in the Notice of Stock Option Grant may be adjusted
in accordance with the Company’s part-time work policy or the terms of an agreement between you and the Company
pertaining to your part-time schedule.
Restrictions on Exercise
The Company will not permit you to exercise this option if the issuance of shares at that time would violate any law
or regulation.
Notice of Exercise
When you wish to exercise this option, you must notify the Company by filing the proper “Notice of Exercise” form
at the address given on the form. Your notice must specify how many shares you wish to purchase. Your notice must
also specify how your shares should be registered. The notice will be effective when the Company receives it.
If someone else wants to exercise this option after your death, that person must prove to the Company’s satisfaction
that he or she is entitled to do so.
Form of Payment
When you submit your notice of exercise, you must include payment of the option exercise price for the shares that
you are purchasing. To the extent permitted by applicable law, payment may be made in one (or a combination of two
or more) of the following forms:
· Your personal check, a cashier’s check or a money order.
· Certificates for shares of Company stock that you own, along with any forms needed to effect a transfer of those
shares to the Company. The value of the shares, determined as of the effective date of the option exercise, will be
applied to the option exercise price. Instead of surrendering shares of Company stock, you may attest to the
ownership of those shares on a form provided by the Company and have the same number of shares subtracted
from the option shares issued to you. However, you may not surrender, or attest to the ownership of, shares of
Company stock in payment of
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the exercise price if your action would cause the Company to recognize compensation expense (or additional
compensation expense) with respect to this option for financial reporting purposes.
· Irrevocable directions to a securities broker approved by the Company to sell all or part of your option shares and
to deliver to the Company from the sale proceeds an amount sufficient to pay the option exercise price and any
withholding taxes. (The balance of the sale proceeds, if any, will be delivered to you.) The directions must be
given by signing a special “Notice of Exercise” form provided by the Company.
· Irrevocable directions to a securities broker or lender approved by the Company to pledge option shares as security
for a loan and to deliver to the Company from the loan proceeds an amount sufficient to pay the option exercise
price and any withholding taxes. The directions must be given by signing a special “Notice of Exercise” form
provided by the Company.
Withholding Taxes and Stock
Withholding
You will not be allowed to exercise this option unless you make arrangements acceptable to the Company to pay any
withholding taxes that may be due as a result of the option exercise. With the Company’s consent, these arrangements
may include withholding shares of Company stock that otherwise would be issued to you when you exercise this
option. The value of these shares, determined as of the effective date of the option exercise, will be applied to the
withholding taxes.
Restrictions on Resale
Transfer of Option
You agree not to sell any option shares at a time when applicable laws, Company policies or an agreement between
the Company and its underwriters prohibit a sale. This restriction will apply as long as your Service continues and for
such period of time after the termination of your Service as the Company may specify.
Prior to your death, only you may exercise this option. You cannot transfer or assign this option. For instance, you
may not sell this option or use it as security for a loan. If you attempt to do any of these things, this option will
immediately become invalid. You may, however, dispose of this option in your will or a beneficiary designation.
Regardless of any marital property settlement agreement, the Company is not obligated to honor a notice of exercise
from your former spouse, nor is the Company obligated to recognize your former spouse’s interest in your option in
any other way.
Retention Rights
Your option or this Agreement does not give you the right to be retained by the Company or a subsidiary of the
Company in any capacity. The Company and its subsidiaries reserve the right to terminate your Service at
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any time, with or without cause.
Stockholder Rights
Adjustments
Applicable Law
You, or your estate or heirs, have no rights as a stockholder of the Company until you have exercised this option by
giving the required notice to the Company and paying the exercise price. No adjustments are made for dividends or
other rights if the applicable record date occurs before you exercise this option, except as described in the Plan.
In the event of a stock split, a stock dividend or a similar change in Company stock, the number of shares covered by
this option and the exercise price per share may be adjusted pursuant to the Plan.
This Agreement will be interpreted and enforced under the laws of the State of Delaware (without regard to their
choice-of-law provisions).
The Plan and Other Agreements
The text of the Plan is incorporated in this Agreement by reference.
This Agreement and the Plan constitute the entire understanding between you and the Company regarding this option.
Any prior agreements, commitments or negotiations concerning this option are superseded. This Agreement may be
amended only by another written agreement between the parties.
BY ACCEPTING THIS STOCK OPTION GRANT, YOU AGREE TO ALL OF THE TERMS AND CONDITIONS DESCRIBED ABOVE AND IN
THE PLAN.
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Form of Notice of Restricted Stock Award and Restricted Stock Agreement under 2004 Equity Incentive Plan (form in effect through 2010)
THERAVANCE, INC. 2004 EQUITY INCENTIVE PLAN
NOTICE OF RESTRICTED STOCK AWARD
You have been granted restricted shares of Common Stock of Theravance, Inc. (the “Company”) on the following terms:
Name of Recipient:
«Name»
Total Number of Shares Granted:
«TotalShares»
Fair Market Value per Share:
$«ValuePerShare»
Total Fair Market Value of Award:
$«TotalValue»
Date of Grant:
Vesting Commencement Date:
Vesting Schedule:
«DateGrant»
«VestDay»
«VestSchedule»
You and the Company agree that these shares are granted under and governed by the terms and conditions of the Theravance, Inc. 2004 Equity Incentive Plan
(the “Plan”) and the Restricted Stock Agreement, which is attached to and made a part of this document.
You further agree that the Company may deliver by email all documents relating to the Plan or this award (including, without limitation, prospectuses
required by the Securities and Exchange Commission) and all other documents that the Company is required to deliver to its security holders (including,
without limitation, annual reports and proxy statements). You also agree that the Company may deliver these documents by posting them on a web site
maintained by the Company or by a third party under contract with the Company. If the Company posts these documents on a web site, it will notify you by
email.
RECIPIENT:
THERAVANCE, INC.
By:
Title:
THERAVANCE, INC. 2004 EQUITY INCENTIVE PLAN:
RESTRICTED STOCK AGREEMENT
Payment for Shares
No payment is required for the shares that you are receiving, except for satisfying any withholding taxes that may be
due as a result of the grant of this award or the vesting or transfer of the shares.
Transfer
Vesting
Change in Control
On the terms and conditions set forth in the Notice of Restricted Stock Award and this Agreement, the Company
agrees to transfer to you the number of Shares set forth in the Notice of Restricted Stock Award.
The shares will vest in installments, as shown in the Notice of Restricted Stock Award, as you continue in service as
an employee, consultant or outside director of the Company or a parent or subsidiary of the Company (“Service”).
The shares will fully vest if the Company is subject to a “Change in Control” (as defined in the Plan) before your
Service terminates and you are subject to an Involuntary Termination (as defined below) within 3 months prior or 24
months after the Change in Control. Should the vesting of the shares accelerate as the result of a Change in Control
prior to the First Vesting Date, the acceleration of vesting shall be deferred as to the additional shares until the First
Vesting Date.
Involuntary Termination
For purposes of this Agreement, “Involuntary Termination” means the termination of your Service by reason of:
(a) an involuntary dismissal or discharge by the Company for reasons other than for Cause; or
(b) your voluntary resignation following (i) a change in your position with the Company (or Parent or Subsidiary
employing you) which materially reduces your level of responsibility, (ii) a reduction in your level of
compensation (including base salary, fringe benefits and participation in corporate-performance based bonus
or incentive programs) or (iii) a relocation of your workplace more than fifty miles away from the workplace
designated by the Company on your initial date of service, provided and only if such change, reduction or
relocation is effected by the Company without your consent.
For purposes of this Agreement, “Cause” shall mean (i) the unauthorized use or disclosure of the confidential
information or trade secrets of the Company, which use causes material harm to the
Shares Restricted
Company, (ii) conviction of a felony under the laws of the United States or any state thereof, (iii) gross negligence or
(iv) repeated failure to perform lawful assigned duties for thirty days after receiving written notification from the
Board of Directors.
No additional shares will vest after your Service has terminated for any reason, except to the extent set forth above if
you are subject to an Involuntary Termination within 3 months prior to a Change in Control.
Unvested shares will be considered “Restricted Shares.” You may not sell, transfer, pledge or otherwise dispose of
any Restricted Shares without the written consent of the Company, except as provided in the next sentence. You may
transfer Restricted Shares to your spouse, children or grandchildren or to a trust established by you for the benefit of
yourself or your spouse, children or grandchildren. However, a transferee of Restricted Shares must agree in writing
on a form prescribed by the Company to be bound by all provisions of this Agreement.
Forfeiture
If your Service terminates for any reason, then your shares will be forfeited to the extent that they have not vested
before the termination date and do not vest as a result of the termination. This means that the Restricted Shares will
immediately revert to the Company. You receive no payment for Restricted Shares that are forfeited. The Company
determines when your Service terminates for this purpose.
Leaves of Absence and Part-
Time Work
For purposes of this award, your Service does not terminate when you go on a military leave, a sick leave or another
bona fide leave of absence, if the leave was approved by the Company in writing. But your Service terminates when
the approved leave ends, unless you immediately return to active work.
If you go on a leave of absence, then the vesting schedule specified in the Notice of Restricted Stock Award may be
adjusted in accordance with the Company’s leave of absence policy or the terms of your leave. If you commence
working on a part-time basis, then the vesting schedule specified in the Notice of Restricted Stock Award may be
adjusted in accordance with the Company’s part-time work policy or the terms of an agreement between you and the
Company pertaining to your part-time schedule.
Stock Certificates
The certificates for Restricted Shares have stamped on them a special legend referring to the Company’s forfeiture
right. In addition to or in lieu of imposing the legend, the Company may hold the certificates in escrow. As your
vested percentage increases, you may request (at reasonable intervals) that the Company release to you a non-
legended
2
Voting Rights
You may vote your shares even before they vest.
certificate for your vested shares.
Withholding Taxes
Restrictions on Resale
No Retention Rights
Adjustments
Applicable Law
No stock certificates will be released to you unless you have made arrangements acceptable to the Company to pay
any withholding taxes that may be due as a result of this award or the vesting of the shares. With the Company’s
consent, these arrangements may include (a) withholding shares of Company stock that otherwise would be issued to
you when they vest or (b) surrendering shares that you previously acquired. The fair market value of the shares you
surrender, determined as of the date taxes otherwise would have been withheld in cash, will be applied as a credit
against the withholding taxes.
You agree not to sell any shares at a time when applicable laws, Company policies or an agreement between the
Company and its underwriters prohibit a sale. This restriction will apply as long as your Service continues and for
such period of time after the termination of your Service as the Company may specify.
Your award or this Agreement does not give you the right to be employed or retained by the Company or a subsidiary
of the Company in any capacity. The Company and its subsidiaries reserve the right to terminate your Service at any
time, with or without cause.
In the event of a stock split, a stock dividend or a similar change in Company stock, the number of Restricted Shares
that remain subject to forfeiture will be adjusted accordingly.
This Agreement will be interpreted and enforced under the laws of the State of Delaware (without regard to their
choice-of-law provisions).
The Plan and Other Agreements
The text of the Plan is incorporated in this Agreement by reference.
This Agreement and the Plan constitute the entire understanding between you and the Company regarding this award.
Any prior agreements, commitments or negotiations concerning this award are superseded. This Agreement may be
amended only by another written agreement between the parties.
BY SIGNING THE COVER SHEET OF THIS AGREEMENT, YOU AGREE TO ALL OF THE
TERMS AND CONDITIONS DESCRIBED ABOVE AND IN THE PLAN.
3
Form of Notice of Stock Option Grant and Stock Option Agreement under 2004 Equity Incentive Plan (form in effect from 2007)
THERAVANCE, INC. 2004 EQUITY INCENTIVE PLAN
NOTICE OF STOCK OPTION GRANT
You have been granted the following option to purchase shares of the Common Stock of Theravance, Inc. (the “Company”):
Name of Optionee:
«First» «Last»
ID Number:
Total Number of Shares:
«ID»
«Shares»
Type of Option:
Nonstatutory Stock Option
Grant Number:
Exercise Price Per Share:
Date of Grant:
Vesting Schedule:
Expiration Date:
«Number»
«Price»
«Grant_Date»
«VestSchedule»
«Expiration_Date». This option expires earlier if your Service terminates earlier, as described in the
Stock Option Agreement.
You and the Company agree that this option is granted under and governed by the terms and conditions of the Stock Option Agreement, which is attached to
and made a part of this document, and the 2004 Equity Incentive Plan (the “Plan”).
You further agree that the Company may deliver by email all documents relating to the Plan or this option (including, without limitation, prospectuses
required by the Securities and Exchange Commission) and all other documents that the Company is required to deliver to its security holders (including,
without limitation, annual reports and proxy statements). You also agree that the Company may deliver these documents by posting them on a web site
maintained by the Company or by a third party under contract with the Company. If the Company posts these documents on a web site, it will notify you by
email.
THERAVANCE, INC. 2004 EQUITY INCENTIVE PLAN
STOCK OPTION AGREEMENT
Tax Treatment
This option is a nonstatutory stock option.
Vesting
This option becomes exercisable in installments, as shown in the Notice of Stock Option Grant.
This option shall become exercisable in full if not assumed or a new option substituted pursuant to Section 11.3 of the
Plan. In addition, this option becomes exercisable in full if the Company is subject to a “Change in Control” (as
defined in the Plan) before your Service terminates, and you are subject to an Involuntary Termination (as defined
below) within three months prior or 24 months after the Change in Control.
For purposes of this Agreement, “Cause” shall mean (i) the unauthorized use or disclosure of the confidential
information or trade secrets of the Company, which use causes material harm to the Company, (ii) conviction of a
felony under the laws of the United States or any state thereof, (iii) gross negligence or (iv) repeated failure to
perform lawful assigned duties for thirty days after receiving written notification from the Board of Directors.
For purposes of this Agreement, “Involuntary Termination” means the termination of your Service by reason of:
(a) an involuntary dismissal or discharge by the Company for reasons other than for Cause; or
(b) your voluntary resignation following (i) a change in your position with the Company (or Parent or
Subsidiary employing you) which materially reduces your level of responsibility, (ii) a reduction in your
level of compensation (including base salary, fringe benefits and participation in corporate-performance
based bonus or incentive programs) or (iii) a relocation of your workplace more than fifty miles away from
the workplace designated by the Company on your initial date of service, provided and only if such change,
reduction or relocation is effected by the Company without your consent.
For purposes of this Agreement, “Service” means your service as an Employee, Outside Director or Consultant.
Term
No additional shares will vest after your Service has terminated for any reason, except to the extent set forth above if
you are subject to an Involuntary Termination within three months prior to a Change in Control.
th
This option expires in any event at the close of business at Company headquarters on the day before the
10 anniversary of the Date of Grant, as shown in the Notice of Stock Option Grant. (It will expire earlier if your
Service terminates, as described below.) You may exercise this option at any time before its expiration under the
preceding sentence, but only to the extent that this option had become exercisable before your Service terminated.
Regular Termination
If your Service terminates for any reason except death or total and permanent disability, then this option will expire at
the close of business at Company headquarters on the date three months after your termination date. The Company
determines when your Service terminates for this purpose.
Death
Disability
If you die before your Service terminates, then this option will expire at the close of business at Company
headquarters on the date that is 12 months after the date of death.
If your Service terminates because of your total and permanent disability, then this option will expire at the close of
business at Company headquarters on the date 12 months after your termination date.
For all purposes under this Agreement, “total and permanent disability” means that you are unable to engage in any
substantial gainful activity by reason of any medically determinable physical or mental impairment which can be
expected to result in death or which has lasted, or can be expected to last, for a continuous period of not less than one
year.
Leaves of Absence and Part-
Time Work
For purposes of this option, your Service does not terminate when you go on a military leave, a sick leave or another
bona fide leave of absence, if the leave was approved by the Company in writing. But your Service terminates when
the approved leave ends, unless you immediately return to active work.
If you go on a leave of absence, then the vesting schedule specified in the Notice of Stock Option Grant may be
adjusted in accordance with the Company’s leave of absence policy or the terms of your leave. If you commence
working on a part-time basis, then the vesting schedule specified in the Notice of Stock Option Grant may be adjusted
in accordance with the Company’s part-time work policy or the terms of an agreement between you and the Company
pertaining to your part-time
3
schedule.
Restrictions on Exercise
The Company will not permit you to exercise this option if the issuance of shares at that time would violate any law
or regulation.
Notice of Exercise
When you wish to exercise this option, you must notify the Company by filing the proper “Notice of Exercise” form
at the address given on the form. Your notice must specify how many shares you wish to purchase. Your notice must
also specify how your shares should be registered. The notice will be effective when the Company receives it.
If someone else wants to exercise this option after your death, that person must prove to the Company’s satisfaction
that he or she is entitled to do so.
Form of Payment
When you submit your notice of exercise, you must include payment of the option exercise price for the shares that
you are purchasing. To the extent permitted by applicable law, payment may be made in one (or a combination of two
or more) of the following forms:
· Your personal check, a cashier’s check or a money order.
· Certificates for shares of Company stock that you own, along with any forms needed to effect a transfer of those
shares to the Company. The value of the shares, determined as of the effective date of the option exercise, will
be applied to the option exercise price. Instead of surrendering shares of Company stock, you may attest to the
ownership of those shares on a form provided by the Company and have the same number of shares subtracted
from the option shares issued to you. However, you may not surrender, or attest to the ownership of, shares of
Company stock in payment of the exercise price if your action would cause the Company to recognize
compensation expense (or additional compensation expense) with respect to this option for financial reporting
purposes.
· Irrevocable directions to a securities broker approved by the Company to sell all or part of your option shares
and to deliver to the Company from the sale proceeds an amount sufficient to pay the option exercise price and
any withholding taxes. (The balance of the sale proceeds, if any, will be delivered to you.) The directions must
be given by signing a special “Notice of Exercise” form provided by the Company.
· Irrevocable directions to a securities broker or lender approved by the Company to pledge option shares as
security for a loan and to deliver to the Company from the loan proceeds an amount sufficient to pay the option
exercise price and any withholding taxes. The directions
4
must be given by signing a special “Notice of Exercise” form provided by the Company.
Withholding Taxes and Stock
Withholding
You will not be allowed to exercise this option unless you make arrangements acceptable to the Company to pay any
withholding taxes that may be due as a result of the option exercise. With the Company’s consent, these arrangements
may include withholding shares of Company stock that otherwise would be issued to you when you exercise this
option. The value of these shares, determined as of the effective date of the option exercise, will be applied to the
withholding taxes.
Restrictions on Resale
Transfer of Option
You agree not to sell any option shares at a time when applicable laws, Company policies or an agreement between
the Company and its underwriters prohibit a sale. This restriction will apply as long as your Service continues and for
such period of time after the termination of your Service as the Company may specify.
Prior to your death, only you may exercise this option. You cannot transfer or assign this option. For instance, you
may not sell this option or use it as security for a loan. If you attempt to do any of these things, this option will
immediately become invalid. You may, however, dispose of this option in your will or a beneficiary designation.
Regardless of any marital property settlement agreement, the Company is not obligated to honor a notice of exercise
from your former spouse, nor is the Company obligated to recognize your former spouse’s interest in your option in
any other way.
Retention Rights
Stockholder Rights
Adjustments
Applicable Law
Your option or this Agreement does not give you the right to be retained by the Company or a subsidiary of the
Company in any capacity. The Company and its subsidiaries reserve the right to terminate your Service at any time,
with or without cause.
You, or your estate or heirs, have no rights as a stockholder of the Company until you have exercised this option by
giving the required notice to the Company and paying the exercise price. No adjustments are made for dividends or
other rights if the applicable record date occurs before you exercise this option, except as described in the Plan.
In the event of a stock split, a stock dividend or a similar change in Company stock, the number of shares covered by
this option and the exercise price per share may be adjusted pursuant to the Plan.
This Agreement will be interpreted and enforced under the laws of the State of Delaware (without regard to their
choice-of-law provisions).
5
The Plan and Other
Agreements
The text of the Plan is incorporated in this Agreement by reference.
This Agreement and the Plan constitute the entire understanding between you and the Company regarding this option.
Any prior agreements, commitments or negotiations concerning this option are superseded. This Agreement may be
amended only by another written agreement between the parties.
BY ACCEPTING THIS STOCK OPTION GRANT, YOU AGREE TO ALL OF THE TERMS AND CONDITIONS DESCRIBED ABOVE AND IN
THE PLAN.
6
Form of Non-Employee Director Notice of Stock Option Grant and Stock Option Agreement under 2004 Equity Incentive Plan (form in effect
through 2006)
THERAVANCE, INC. 2004 EQUITY INCENTIVE PLAN
NOTICE OF STOCK OPTION GRANT
You have been granted the following option to purchase shares of the Common Stock of Theravance, Inc. (the “Company”):
Name of Optionee:
Total Number of Shares:
«Name»
«Shares»
Type of Option:
Nonstatutory Stock Option
Exercise Price Per Share:
$«PricePerShare»
Date of Grant:
Vesting Schedule:
Expiration Date:
«DateGrant»
«VestSched»
«ExpDate». This option expires earlier if your Service terminates earlier, as described in the Stock
Option Agreement.
You and the Company agree that this option is granted under and governed by the terms and conditions of the 2004 Equity Incentive Plan (the “Plan”) and the
Stock Option Agreement, both of which are attached to and made a part of this document.
You further agree that the Company may deliver by email all documents relating to the Plan or this option (including, without limitation, prospectuses
required by the Securities and Exchange Commission) and all other documents that the Company is required to deliver to its security holders (including,
without limitation, annual reports and proxy statements). You also agree that the Company may deliver these documents by posting them on a web site
maintained by the Company or by a third party under contract with the Company. If the Company posts these documents on a web site, it will notify you by
email.
OPTIONEE:
THERAVANCE, INC.
By:
Title:
THERAVANCE, INC. 2004 EQUITY INCENTIVE PLAN
STOCK OPTION AGREEMENT
New Director Grant
Tax Treatment
This option is intended to be an incentive stock option under section 422 of the Internal Revenue Code or a
nonstatutory stock option, as provided in the Notice of Stock Option Grant.
Vesting
This option becomes exercisable as shown in the Notice of Stock Option Grant.
This option shall become exercisable in full if not assumed or a new option substituted pursuant to Section 8(b)(ii) or
(iii) of the Plan. In addition, this option becomes exercisable in full if the Company is subject to a “Change in
Control” (as defined in the Plan) before your Service terminates. Should the exercisability of this option accelerate as
a result of the occurrence of a Change in Control prior to the First Exercise Date, the right to exercise this option shall
be deferred as to the additional shares until the First Exercise Date, provided and only if this option is assumed by the
surviving corporation or its parent or the surviving corporation or its parent substitutes its own option for this option.
For purposes of this Agreement, “Cause” shall mean (i) the unauthorized use or disclosure of the confidential
information or trade secrets of the Company, which use causes material harm to the Company, (ii) conviction of a
felony under the laws of the United States or any state thereof, (iii) gross negligence or (iv) repeated failure to
perform lawful assigned duties for thirty days after receiving written notification from the Board of Directors.
For purposes of this Agreement, “Put Date” shall mean the day after the final day of the Put Period, as such term is
defined in the Restated Certificate of Incorporation of Theravance, Inc. or, if earlier, the consummation of a Qualified
Change in Control as defined in the Restated Certificate of Incorporation of Theravance, Inc.
For purposes of this Agreement, “Service” means your service as an Outside Director.
This option will in no event become exercisable for additional shares after your Service has terminated for any reason
except as set forth above
Term
This option expires in any event at the close of business at Company
headquarters on the day before the 10 anniversary of the Date of Grant, as shown in the Notice of Stock Option
Grant. (It will expire earlier if your Service terminates, as described below.)
th
Termination Prior to the Put
Date
If your Service terminates for any reason prior to the Put Date, then this option will expire at the close of business at
Company headquarters on the date 36 months after your termination date. The Company determines when your
Service terminates for this purpose.
Regular Termination on or after
the Put Date
If your Service terminates for any reason on or after the Put Date except a Qualified Retirement, then this option will
expire at the close of business at Company headquarters on the date 12 months after your termination date. The
Company determines when your Service terminates for this purpose.
Qualified Retirement
If you retire from Service at or after the age of 65 or at or after the age of 55 and have provided 10 years of
consecutive Service for the Company prior to retirement (a “Qualified Retirement”), then this option will expire at the
close of business at the Company headquarters on the date 36 months after the date of your Qualified Retirement.
Restrictions on Exercise
The Company will not permit you to exercise this option if the issuance of shares at that time would violate any law
or regulation.
Notice of Exercise
When you wish to exercise this option, you must notify the Company by filing the proper “Notice of Exercise” form
at the address given on the form. Your notice must specify how many shares you wish to purchase. Your notice must
also specify how your shares should be registered. The notice will be effective when the Company receives it.
If someone else wants to exercise this option after your death, that person must prove to the Company’s satisfaction
that he or she is entitled to do so.
Form of Payment
When you submit your notice of exercise, you must include payment of the option exercise price for the shares that
you are purchasing. To the extent permitted by applicable law, payment may be made in one (or a combination of two
or more) of the following forms:
· Your personal check, a cashier’s check or a money order.
· Certificates for shares of Company stock that you own, along with any forms needed to effect a transfer of those
shares to the Company. The value of the shares, determined as of the effective date of the option exercise, will
be applied to the option exercise price. Instead of surrendering shares of Company stock, you may attest to the
ownership of those shares on a form provided by the
2
Company and have the same number of shares subtracted from the option shares issued to you. However, you
may not surrender, or attest to the ownership of, shares of Company stock in payment of the exercise price if
your action would cause the Company to recognize compensation expense (or additional compensation
expense) with respect to this option for financial reporting purposes.
· Irrevocable directions to a securities broker approved by the Company to sell all or part of your option shares
and to deliver to the Company from the sale proceeds an amount sufficient to pay the option exercise price and
any withholding taxes. (The balance of the sale proceeds, if any, will be delivered to you.) The directions must
be given by signing a special “Notice of Exercise” form provided by the Company.
Withholding Taxes and Stock
Withholding
You will not be allowed to exercise this option unless you make arrangements acceptable to the Company to pay any
withholding taxes that may be due as a result of the option exercise. With the Company’s consent, these arrangements
may include withholding shares of Company stock that otherwise would be issued to you when you exercise this
option. The value of these shares, determined as of the effective date of the option exercise, will be applied to the
withholding taxes.
Restrictions on Resale
Transfer of Option
Retention Rights
Stockholder Rights
Adjustments
Applicable Law
The Plan and Other
Agreements
You agree not to sell any option shares at a time when applicable laws, Company policies or an agreement between
the Company and its underwriters prohibit a sale. This restriction will apply as long as your Service continues and for
such period of time after the termination of your Service as the Company may specify.
Prior to your death, only you may exercise this option. You cannot transfer or assign this option. For instance, you
may not sell this option or use it as security for a loan. If you attempt to do any of these things, this option will
immediately become invalid. You may, however, dispose of this option in your will or a beneficiary designation.
Regardless of any marital property settlement agreement, the Company is not obligated to honor a notice of exercise
from your former spouse, nor is the Company obligated to recognize your former spouse’s interest in your option in
any other way.
Your option or this Agreement does not give you the right to be retained by the Company or a subsidiary of the
Company in any capacity. The Company and its subsidiaries reserve the right to terminate your Service at any time,
with or without cause. Nor shall this Agreement in any way be construed or interpreted so as to affect adversely or
otherwise impair the right of the Company or the stockholders to remove Optionee from the Board of Directors at any
time in accordance with the provisions of
3
applicable law.
You, or your estate or heirs, have no rights as a stockholder of the Company until you have exercised this option by
giving the required notice to the Company and paying the exercise price. No adjustments are made for dividends or
other rights if the applicable record date occurs before you exercise this option, except as described in the Plan.
In the event of a stock split, a stock dividend or a similar change in Company stock, the number of shares covered by
this option and the exercise price per share may be adjusted pursuant to the Plan.
This Agreement will be interpreted and enforced under the laws of the State of Delaware (without regard to their
choice-of-law provisions).
The text of the Plan is incorporated in this Agreement by reference.
This Agreement and the Plan constitute the entire understanding between you and the Company regarding this option.
Any prior agreements, commitments or negotiations concerning this option are superseded. This Agreement may be
amended only by another written agreement between the parties.
BY SIGNING THE COVER SHEET OF THIS AGREEMENT, YOU AGREE TO ALL OF THE TERMS AND CONDITIONS DESCRIBED
ABOVE AND IN THE PLAN.
4
Form of Non-Employee Director Notice of Stock Option Grant and Stock Option Agreement under 2004 Equity Incentive Plan (form in effect from
2007)
THERAVANCE, INC. 2004 EQUITY INCENTIVE PLAN
NOTICE OF STOCK OPTION GRANT
You have been granted the following option to purchase shares of the Common Stock of Theravance, Inc. (the “Company”):
Name of Optionee:
Total Number of Shares:
«Name»
«Shares»
Type of Option:
Nonstatutory Stock Option
Exercise Price Per Share:
$«PricePerShare»
Date of Grant:
Vesting Schedule:
Expiration Date:
«DateGrant»
«VestSched»
«ExpDate». This option expires earlier if your Service terminates earlier, as
described in the Stock Option Agreement.
You and the Company agree that this option is granted under and governed by the terms and conditions of the 2004 Equity Incentive Plan (the “Plan”) and the
Stock Option Agreement, both of which are attached to and made a part of this document.
You further agree that the Company may deliver by email all documents relating to the Plan or this option (including, without limitation, prospectuses
required by the Securities and Exchange Commission) and all other documents that the Company is required to deliver to its security holders (including,
without limitation, annual reports and proxy statements). You also agree that the Company may deliver these documents by posting them on a web site
maintained by the Company or by a third party under contract with the Company. If the Company posts these documents on a web site, it will notify you by
email.
OPTIONEE:
THERAVANCE, INC.
By:
Title:
THERAVANCE, INC. 2004 EQUITY INCENTIVE PLAN
STOCK OPTION AGREEMENT
New Director Grant
Tax Treatment
This option is intended to be a nonstatutory stock option, as provided in the Notice of Stock Option Grant.
Vesting
This option becomes exercisable as shown in the Notice of Stock Option Grant.
This option shall become exercisable in full if not assumed or a new option substituted pursuant to Section 8(b)(ii) or
(iii) of the Plan. In addition, this option becomes exercisable in full if the Company is subject to a “Change in Control”
(as defined in the Plan) before your Service terminates. Should the exercisability of this option accelerate as a result of the
occurrence of a Change in Control prior to the First Exercise Date, the right to exercise this option shall be deferred as to
the additional shares until the First Exercise Date, provided and only if this option is assumed by the surviving corporation
or its parent or the surviving corporation or its parent substitutes its own option for this option.
For purposes of this Agreement, “Cause” shall mean (i) the unauthorized use or disclosure of the confidential information
or trade secrets of the Company, which use causes material harm to the Company, (ii) conviction of a felony under the
laws of the United States or any state thereof, (iii) gross negligence or (iv) repeated failure to perform lawful assigned
duties for thirty days after receiving written notification from the Board of Directors.
For purposes of this Agreement, “Put Date” shall mean the day after the final day of the Put Period, as such term is
defined in the Restated Certificate of Incorporation of Theravance, Inc. or, if earlier, the consummation of a Qualified
Change in Control as defined in the Restated Certificate of Incorporation of Theravance, Inc.
For purposes of this Agreement, “Service” means your service as an Outside Director.
This option will in no event become exercisable for additional shares after your Service has terminated for any reason
except as set forth above.
Term
This option expires in any event at the close of business at Company headquarters on the day before the 10 anniversary of
the Date of Grant,
th
as shown in the Notice of Stock Option Grant. (It will expire earlier if your Service terminates, as described below.)
Regular Termination
If your Service terminates for any reason except a termination for Cause, then this option will expire at the close of
business at Company headquarters on the date 36 months after your termination date. If your Service terminates for Cause,
then this option will expire on your termination date. The Company determines when your Service terminates for this
purpose.
Restrictions on Exercise
The Company will not permit you to exercise this option if the issuance of shares at that time would violate any law or
regulation.
Notice of Exercise
When you wish to exercise this option, you must notify the Company by filing the proper “Notice of Exercise” form at the
address given on the form. Your notice must specify how many shares you wish to purchase. Your notice must also specify
how your shares should be registered. The notice will be effective when the Company receives it.
If someone else wants to exercise this option after your death, that person must prove to the Company’s satisfaction that he
or she is entitled to do so.
Form of Payment
When you submit your notice of exercise, you must include payment of the option exercise price for the shares that you
are purchasing. To the extent permitted by applicable law, payment may be made in one (or a combination of two or more)
of the following forms:
· Your personal check, a cashier’s check or a money order.
· Certificates for shares of Company stock that you own, along with any forms needed to effect a transfer of those
shares to the Company. The value of the shares, determined as of the effective date of the option exercise, will be
applied to the option exercise price. Instead of surrendering shares of Company stock, you may attest to the
ownership of those shares on a form provided by the Company and have the same number of shares subtracted
from the option shares issued to you. However, you may not surrender, or attest to the ownership of, shares of
Company stock in payment of the exercise price if your action would cause the Company to recognize
compensation expense (or additional compensation expense) with respect to this option for financial reporting
purposes.
· Irrevocable directions to a securities broker approved by the Company to sell all or part of your option shares and
to deliver to the Company from the sale proceeds an amount sufficient to pay the option exercise
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price and any withholding taxes. (The balance of the sale proceeds, if any, will be delivered to you.) The
directions must be given by signing a special “Notice of Exercise” form provided by the Company.
Withholding Taxes and Stock
Withholding
You will not be allowed to exercise this option unless you make arrangements acceptable to the Company to pay any
withholding taxes that may be due as a result of the option exercise. With the Company’s consent, these arrangements may
include withholding shares of Company stock that otherwise would be issued to you when you exercise this option. The
value of these shares, determined as of the effective date of the option exercise, will be applied to the withholding taxes.
Restrictions on Resale
Transfer of Option
Retention Rights
You agree not to sell any option shares at a time when applicable laws, Company policies or an agreement between the
Company and its underwriters prohibit a sale. This restriction will apply as long as your Service continues and for such
period of time after the termination of your Service as the Company may specify.
Prior to your death, only you may exercise this option. You cannot transfer or assign this option. For instance, you may not
sell this option or use it as security for a loan. If you attempt to do any of these things, this option will immediately
become invalid. You may, however, dispose of this option in your will or a beneficiary designation.
Regardless of any marital property settlement agreement, the Company is not obligated to honor a notice of exercise from
your former spouse, nor is the Company obligated to recognize your former spouse’s interest in your option in any other
way.
Your option or this Agreement does not give you the right to be retained by the Company or a subsidiary of the Company
in any capacity. The Company and its subsidiaries reserve the right to terminate your Service at any time, with or without
cause. Nor shall this Agreement in any way be construed or interpreted so as to affect adversely or otherwise impair the
right of the Company or the stockholders to remove Optionee from the Board of Directors at any time in accordance with
the provisions of applicable law.
Stockholder Rights
You, or your estate or heirs, have no rights as a stockholder of the Company until you have exercised this option by giving
the required notice to the Company and paying the exercise price. No adjustments are made for dividends or other rights if
the applicable record date occurs before you exercise this option, except as described in the Plan.
Adjustments
In the event of a stock split, a stock dividend or a similar change in Company stock, the number of shares covered by this
option and the
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exercise price per share may be adjusted pursuant to the Plan.
Applicable Law
The Plan and Other
Agreements
This Agreement will be interpreted and enforced under the laws of the State of Delaware (without regard to their choice-
of-law provisions).
The text of the Plan is incorporated in this Agreement by reference.
This Agreement and the Plan constitute the entire understanding between you and the Company regarding this option. Any
prior agreements, commitments or negotiations concerning this option are superseded. This Agreement may be amended
only by another written agreement between the parties.
BY SIGNING THE COVER SHEET OF THIS AGREEMENT, YOU AGREE TO ALL OF THE TERMS AND
CONDITIONS DESCRIBED ABOVE AND IN THE PLAN.
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Form of Time-Based Vesting Notice of Restricted Stock Unit Award and Restricted Stock Unit Agreement under 2004 Equity Incentive Plan (form in
effect through 2007)
THERAVANCE, INC. 2004 EQUITY INCENTIVE PLAN
NOTICE OF RESTRICTED STOCK UNIT AWARD
You have been granted the number of restricted stock units indicated below by Theravance, Inc. (the “Company”) on the following terms:
Name: «Name»
Restricted Stock Unit Award Details:
Date of Grant:
Restricted Stock Units:
Vesting Commencement Date:
«DateGrant»
«TotalShares»
«VestComDate»
Each restricted stock unit (the “Restricted Stock Unit”) represents the right to receive one share of the Company’s Common Stock subject to the
terms and conditions contained in the Restricted Stock Unit Agreement.
Vesting Schedule:
Vesting is dependent upon continuous service as an employee of the Company, a Parent, a Subsidiary or an Affiliate (“Service”) throughout the
vesting period. The units will vest as follows: 25% on <
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