Innoviva, Inc. - Quarter Report: 2012 March (Form 10-Q)

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UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

 

FORM 10-Q

 

(Mark One)

 

x                QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the quarterly period ended March 31, 2012

 

OR

 

o                   TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

 

For the transition period from                    to

 

Commission File Number: 0-30319

 

THERAVANCE, INC.

(Exact Name of Registrant as Specified in its Charter)

 

 

901 Gateway Boulevard

South San Francisco, CA 94080

(Address of Principal Executive Offices including Zip Code)

 

(650) 808-6000

(Registrant’s Telephone Number, Including Area Code)

 

 

Indicate by check mark whether the registrant: (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 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 x 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 405 of Regulation S-T (§ 232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit and post such files). Yes x No o

 

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, or a smaller reporting company. See definitions of “large accelerated filer,” “accelerated filer,” and “smaller reporting company” in Rule 12b-2 of the Exchange Act. (Check one):

 

 

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes o No x

 

The number of shares of registrant’s common stock outstanding on April 25, 2012 was 86,542,315.

 

 

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TABLE OF CONTENTS

 

PART I — FINANCIAL INFORMATION	3
Item 1. Financial Statements	3
Condensed Consolidated Balance Sheets as of March 31, 2012 and December 31, 2011	3
Condensed Consolidated Statements of Operations for the three months ended March 31, 2012 and 2011	4
Condensed Consolidated Statements of Comprehensive Income (Loss) for the three months ended March 31, 2012 and 2011	5
Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2012 and 2011	6
Notes to Condensed Consolidated Financial Statements	7
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations	17
Item 3. Quantitative and Qualitative Disclosures About Market Risk	25
Item 4. Controls and Procedures	25
PART II. OTHER INFORMATION	25
Item 1A. Risk Factors	25
Item 2. Unregistered Sales of Equity Securities and Use of Proceeds	40
Item 6. Exhibits	40
Signatures	41

 

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PART I — FINANCIAL INFORMATION

 

Item 1. Financial Statements

 

THERAVANCE, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except per share data)

 

		March 31, 2012			December 31, 2011
		(Unaudited)			*
Assets
Current assets:
Cash and cash equivalents		$	14,310		$	44,778
Marketable securities		185,854			196,137
Receivable from related party		63			223
Notes receivable, current		200			100
Prepaid and other current assets		3,900			3,525
Total current assets		204,327			244,763
Restricted cash		893			893
Property and equipment, net		10,059			10,372
Notes receivable, non-current		140			240
Other assets, non-current		2,308			2,514
Total assets		$	217,727		$	258,782
Liabilities and stockholders’ equity (net capital deficiency)
Current liabilities:
Accounts payable		$	5,308		$	5,813
Accrued personnel related expenses		4,884			9,643
Accrued clinical and development expenses		6,547			6,956
Accrued interest on convertible subordinated notes		1,078			2,372
Other accrued liabilities		1,974			1,946
Note payable and capital lease, current		13			69
Deferred revenue, current		5,771			18,697
Total current liabilities		25,575			45,496
Convertible subordinated notes		172,500			172,500
Deferred rent		5,678			5,821
Deferred revenue, non-current		7,843			122,017
Commitments and contingencies (Notes 3 and 7)
Stockholders’ equity (net capital deficiency):
Common stock, $0.01 par value; authorized: 200,000 shares; outstanding: 86,470 at March 31, 2012 and 85,543 at December 31, 2011		865			855
Additional paid-in capital		1,236,641			1,228,037
Accumulated other comprehensive income (loss)		(9		)	16
Accumulated deficit		(1,231,366		)	(1,315,960		)
Total stockholders’ equity (net capital deficiency)		6,131			(87,052		)
Total liabilities and stockholders’ equity (net capital deficiency)		$	217,727		$	258,782

*                    Condensed consolidated balance sheet at December 31, 2011 has been derived from audited consolidated financial statements.

 

See accompanying notes to condensed consolidated financial statements.

 

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THERAVANCE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS

(In thousands, except per share data)

(Unaudited)

 

		Three Months Ended March 31,
		2012			2011
Revenue (including amounts from a related party of $1,430 in the three months ended March 31, 2012, and $2,456 in the three months ended March 31, 2011)		$	127,099		$	6,331
Operating expenses:
Research and development		33,202			20,464
General and administrative		7,857			7,169
Total operating expenses		41,059			27,633
Income (loss) from operations		86,040			(21,302		)
Interest income		56			145
Interest expense		(1,502		)	(1,510		)
Net income (loss)		$	84,594		$	(22,667	)
Net income (loss) per share:
Basic		$	1.01		$	(0.28	)
Diluted		$	0.93		$	(0.28	)
Weighted-average number of shares used in per share calculations:
Basic		83,590			80,854
Diluted		92,080			80,854

 

See accompanying notes to condensed consolidated financial statements.

 

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THERAVANCE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (LOSS)

(In thousands, except per share data)

(Unaudited)

 

		Three Months Ended March 31,
		2012			2011
Net income (loss)		$	84,594		$	(22,667	)
Other comprehensive income:
Net unrealized loss on available-for-sale securities, net of tax		(25		)	(5		)
Comprehensive income (loss)		$	84,569		$	(22,672	)

 

See accompanying notes to condensed consolidated financial statements.

 

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THERAVANCE, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

(Unaudited)

 

		Three Months Ended March 31,
		2012			2011
Cash flows from operating activities
Net income (loss)		$	84,594		$	(22,667	)
Adjustments to reconcile net income (loss) to net cash used in operating activities:
Depreciation and amortization		1,910			1,650
Stock-based compensation		6,235			5,541
Forgiveness of notes receivable		—			1
Changes in operating assets and liabilities:
Receivables		160			268
Prepaid expenses and other current assets		(375		)	73
Accounts payable		48			198
Accrued personnel-related expenses, accrued interest on convertible subordinated notes and other current liabilities		(6,657		)	(6,031		)
Deferred rent		(143		)	776
Deferred revenue		(127,100		)	(5,700		)
Net cash used in operating activities		(41,328		)	(25,891		)
Cash flows from investing activities
Purchases of property and equipment		(1,103		)	(1,381		)
Purchases of marketable securities		(35,671		)	(76,408		)
Sales of marketable securities		—			5,000
Maturities of marketable securities		45,158			71,250
Payments received on notes receivable		—			300
Net cash provided by (used in) investing activities		8,384			(1,239		)
Cash flows from financing activities
Payments on note payable and capital lease		(56		)	(62		)
Proceeds from issuances of common stock, net		2,532			11,733
Net cash provided by financing activities		2,476			11,671
Net decrease in cash and cash equivalents		(30,468		)	(15,459		)
Cash and cash equivalents at beginning of period		44,778			163,333
Cash and cash equivalents at end of period		$	14,310		$	147,874

 

See accompanying notes to condensed consolidated financial statements.

 

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Theravance, Inc.

Notes to Condensed consolidated financial statements

(Unaudited)

 

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.

 

Basis of Presentation

 

The accompanying unaudited condensed consolidated financial statements of the Company have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and notes required by GAAP for complete financial statements. In the opinion of the Company’s management, the unaudited condensed consolidated financial statements have been prepared on the same basis as audited consolidated financial statements and include all adjustments, consisting of only normal recurring adjustments, necessary for the fair presentation of the Company’s financial position, results of operations, comprehensive income (loss) and cash flows. The interim results are not necessarily indicative of the results of operations to be expected for the year ending December 31, 2012 or any other period.

 

The accompanying unaudited condensed consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2011 filed with the Securities and Exchange Commission (SEC) on February 27, 2012.

 

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 January 6, 2012, Astellas Pharma Inc. (Astellas), located in Japan. All long-lived assets are maintained in the United States.

 

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 (loss) as a separate component of stockholders’ equity (net capital deficiency). Interest, amortization of purchase premiums and discounts, and realized gains and losses on sales of securities are included in interest. The cost of securities sold is based on the specific identification method.

 

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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.

 

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.

 

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, stock-based compensation arrangements include 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 are to be granted at an exercise price not less than the fair market value per share on the grant date for incentive options and are generally granted with terms of up to ten years and vest over a period of four years. Following the approval by stockholders of the amendment 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 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 deferred tax assets including deferred tax assets related to its net operating loss carryforwards.

 

Recently Adopted Accounting Updates

 

On January 1, 2012, the Company adopted 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 was effective for the Company January 1, 2012. The Company elected the two separate but consecutive statements approach.

 

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2. Net Income (Loss) per Share

 

Basic net income (loss) per share amounts for each period presented were computed by dividing net income (loss) by the weighted-average number of shares of common stock outstanding, less RSAs subject to forfeiture.

 

For the three months ended March 31, 2012, diluted net income per share was computed by dividing net income plus interest on dilutive convertible notes by the weighted-average number of shares of common stock outstanding during each period, less RSAs subject to forfeiture, plus all additional common shares that would have been outstanding assuming dilutive potential common shares had been issued for dilutive convertible notes (see Note 6) and other dilutive securities.

 

Dilutive potential common shares for dilutive convertible notes were calculated based on the “if-converted” method. Under the “if-converted” method, when computing the dilutive effect of convertible notes, net income was adjusted to add back the amount of interest and debt issuance costs recognized in the period and the denominator was adjusted to add back the number of shares that would be issued if the entire obligation was settled in shares.

 

Dilutive potential common shares also include the dilutive effect of the common stock underlying in-the-money stock options and were calculated based on the average share price for each period using the treasury stock method. Under the treasury stock method, the exercise price of an option and the average amount of compensation cost, if any, for future service that the Company has not yet recognized when the option is exercised, are assumed to be used to repurchase shares in the current period. Dilutive potential common shares also reflect the dilutive effect of unvested restricted stock units.

 

For the three months ended March 31, 2011, diluted net loss per share was identical to basic EPS since potential common shares were excluded from the calculation, as their effect was anti-dilutive.

 

The computations for basic and diluted net income (loss) per share were as follows:

 

		Three Months Ended March 31,
(in thousands, except for per share amounts)		2012			2011
Numerator:
Net income (loss) — basic		$	84,594		$	(22,667	)
Add: interest and issuance costs related to convertible notes		1,500			—
Net income (loss) — diluted		86,094			(22,667		)
Denominator:
Weighted-average common shares outstanding		86,292			83,325
Less: unvested RSAs		(2,702		)	(2,471		)
Weighted-average common shares outstanding — basic		83,590			80,854
Dilutive effect of equity incentive plans and ESPP		1,822			—
Dilutive effect of convertible subordinated notes		6,668			—
Weighted-average common shares outstanding and dilutive potential common shares — diluted		92,080			80,854

 

Anti-dilutive securities

 

The following awards were not included in the computation of diluted net income (loss) per share because their effect was anti-dilutive:

 

		Three Months Ended March 31,
(in thousands)		2012		2011
Shares issuable under Equity Incentive Plans and ESPP		4,641		6,673
Shares issuable upon the conversion of convertible debt		—		6,668
Total anti-dilutive securities		4,641		13,341

 

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3. Collaboration Arrangements

 

GSK

 

LABA collaboration

 

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.

 

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.

 

2004 Strategic Alliance

 

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 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.

 

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In connection with the expansion of the MABA program, GSK relinquished its option right on the Company’s MonoAmine Reuptake Inhibitor (MARIN) program and Angiotensin Receptor-NEP Inhibitor (ARNI) program. GSK has no further option rights on any of the Company’s research or development programs under the strategic alliance.

 

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:

 

		Through March 31, 2012
		Common Stock Shares Purchased		Aggregate Amounts (in thousands)
Purchase dates
February 24, 2011		152,278		$	3,609
May 3, 2011		261,299		$	6,689
August 2, 2011		102,466		$	2,020
November 1, 2011		58,411		$	1,298
February 14, 2012		88,468		$	1,603

 

See Note 10 for subsequent event.

 

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:

 

		Through March 31, 2012
(in thousands)		Upfront Fees			Milestone Payments			Total
GSK Collaborations
LABA/RELOVAIR™ collaboration(1)		$	10,000		$	50,000		$	60,000
Strategic alliance agreement		20,000			—			20,000
Strategic alliance—LAMA license(2)		5,000			3,000			8,000
Strategic alliance—MABA program license		6,000			16,000			22,000
Total		$	41,000		$	69,000		$	110,000

(1)              The Company does not currently expect to be eligible for any additional milestones under this collaboration.

 

(2)              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.

 

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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Revenue recognized from GSK under the LABA collaboration and strategic alliance agreements was as follows:

 

		Three Months Ended March 31,
(in thousands)		2012			2011
GSK Collaborations
LABA/RELOVAIR™ collaboration		$	907		$	1,270
Strategic alliance agreement		—			684
Strategic alliance—MABA program license		523			502
Total		$	1,430		$	2,456

 

Astellas

 

License, Development and Commercialization Agreement with 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 previously granted to Astellas ceased upon termination of the agreement and Astellas stopped all promotional sales efforts. Pursuant to the terms of the agreement, Astellas is entitled to a ten-year, 2% royalty on future net sales of VIBATIV®. In March 2012, the Company entered into a series of agreements with Astellas for the purchase of VIBATIV® active pharmaceutical ingredient and raw materials of up to $6.2 million and VIBATIV® finished goods inventory of up to $4.2 million, which is subject to release by a third party manufacturer.

 

In addition, beginning July 1, 2012, the Company is responsible to fund governmental rebate and governmental chargeback claims for Astellas-labeled product sales. As a result of the termination agreement, the Company recorded a liability of $150,000 at March 31, 2012. The Company is evaluating global commercialization alternatives for VIBATIV® either with partners or alone.

 

Through January 6, 2012, the Company had received $191.0 million in upfront license, milestone and other fees from Astellas. The Company previously recorded these payments as deferred revenue and amortized them ratably over its estimated performance period (development and commercialization period). As a result of the termination of the collaboration agreement, the Company has no remaining performance obligations. Therefore the development and commercialization period ended on January 6, 2012. As such, the Company recognized into revenue $125.8 million of deferred revenue related to Astellas in the three months ended March 31, 2012, and it is no longer eligible to receive any further milestone payments.

 

Net revenue recognized under this collaboration agreement was as follows:

 

		Three Months Ended March 31,
(in thousands)		2012			2011
Recognition of deferred revenue		$	125,819		$	3,244
Royalties from net sales of VIBATIV®		—			631
Astellas-labeled product sales allowance		(150		)	—
Total net revenue		$	125,669		$	3,875

 

4. Marketable Securities

 

Available-for-sale money market funds and debt securities were recorded in cash equivalents or marketable securities in the Company’s consolidated balance sheets at their estimated fair value based on prices obtained from commercial pricing services. The Company’s marketable securities were as follows:

 

		March 31, 2012												December 31, 2011
(in thousands)		Amortized Cost			Gross Unrealized Gains			Gross Unrealized Losses			Estimated Fair Value			Amortized Cost			Gross Unrealized Gains			Gross Unrealized Losses			Estimated Fair Value
U.S. government securities		$	61,028		$	5		$	(2	)	$	61,031		$	66,150		$	24		$	—		$	66,174
U.S. government agencies		82,942			2			(15		)	82,929			93,183			9			(17		)	93,175
U.S. corporate notes		550			—			—			550			2,707			—			(2		)	2,705
U.S. commercial paper		45,736			1			—			45,737			34,973			3			—			34,976
Money market funds		6,213			—			—			6,213			38,721			—			—			38,721
Total		196,469			8			(17		)	196,460			235,734			36			(19		)	235,751
Less amounts classified as cash equivalents		(9,713)			—			—			(9,713		)	(38,721		)	—			—			(38,721		)
Less amounts classified as restricted cash		(893)			—			—			(893		)	(893		)	—			—			(893		)
Amounts classified as marketable securities		$	185,863		$	8		$	(17	)	$	185,854		$	196,120		$	36		$	(19	)	$	196,137

 

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At March 31, 2012, all of the marketable securities have 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 March 31, 2012, were temporary in nature. All marketable securities with unrealized losses have been in a loss position for less than twelve months.

 

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.

 

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:

 

		Fair Value Measurements at Reporting Date Using
March 31, 2012		Quoted Prices in Active Markets for Identical Assets			Significant Other Observable Inputs			Significant Unobservable Inputs
(in thousands)		Level 1			Level 2			Level 3			Total
U.S. government securities		$	25,998		$	35,033		$	—		$	61,031
U.S. government agency securities		34,441			48,488			—			82,929
U.S. corporate notes		—			550			—			550
U.S. commercial paper		—			45,737			—			45,737
Money market funds		6,213			—			—			6,213
Total		$	66,652		$	129,808		$	—		$	196,460

 

		Fair Value Measurements at Reporting Date Using
December 31, 2011		Quoted Prices in Active Markets for Identical Assets			Significant Other Observable Inputs			Significant Unobservable Inputs
(in thousands)		Level 1			Level 2			Level 3			Total
U.S. government securities		$	66,174		$	—		$	—		$	66,174
U.S. government agency securities		55,901			37,274			—			93,175
U.S. corporate notes		2,705			—			—			2,705
U.S. commercial paper		—			34,976			—			34,976
Money market funds		38,721			—			—			38,721
Total		$	163,501		$	72,250		$	—		$	235,751

 

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At March 31, 2012, securities with a total fair value of $19.6 million were measured using Level 1 inputs in comparison to December 31, 2011, at which time the securities had a fair value of $19.7 million and were measured using Level 2 inputs. The transfer to Level 1 from Level 2 was primarily the result of increased trading volume of the securities at and around March 31, 2012, compared to December 31, 2011.

 

At March 31, 2012, securities with a total fair value of $56.2 million were measured using Level 2 inputs in comparison to December 31, 2011, at which time the securities had a fair value of $56.5 million and were measured using Level 1 inputs. The transfer to Level 2 from Level 1 was primarily the result of decreased trading volume of the securities at and around March 31, 2012, compared to December 31, 2011.

 

6. Long-Term Debt

 

The fair value of debt was estimated based on the quoted price of the instrument as of March 31, 2012 and December 31, 2011. The carrying values and estimated fair values for the notes were as follows:

 

March 31, 2012

December 31, 2011

(in

Carrying

Estimated Fair Value

Carrying

Estimated Fair Value

thousands)

Value

Level 2

Value

Level 2

Convertible subordinated notes

$

172,500

$

178,436

$

172,500

$

189,588

 

Convertible Subordinated Notes

 

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 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 $2.3 million as of March 31, 2012. Amortization expense was $0.2 million in both the three months ended March 31, 2012 and 2011.

 

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, 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. As of March 31, 2012, the Company did not provide notice of redemption or redeem any of the notes.

 

7. 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 March 31, 2012.

 

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Purchase Obligation

 

On January 6, 2012, Astellas exercised its right to terminate the Company’s collaboration agreement for VIBATIV®. In March 2012, the Company entered into a series of purchase agreements for VIBATIV® active pharmaceutical ingredient and raw materials of up to $6.2 million and VIBATIV® finished goods inventory of up to $4.2 million, which is subject to release by a third party manufacturer.

 

8. Stock-Based Compensation

 

Equity Incentive 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 March 31, 2012, total shares remaining available for issuance under the 2004 Plan were 720,587.

 

Employee Stock Purchase Plan

 

As of March 31, 2012, a total of 2,025,000 shares of common stock were approved and authorized for issuance under the ESPP. Through March 31, 2012, the Company issued 1,468,454 shares under the ESPP at an average price of $10.15 per share. Total shares remaining available for issuance under the ESPP were 556,546 as of March 31, 2012.

 

Stock-Based Compensation Expense

 

The allocation of stock-based compensation expense included in the condensed consolidated statements of operations was as follows:

 

		Three Months Ended March 31,
(in thousands)		2012			2011
Research and development		$	3,529		$	3,132
General and administrative		2,706			2,409
Total stock-based compensation expense		$	6,235		$	5,541

 

As of March 31, 2012, unrecognized compensation expense, net of expected forfeitures, was as follows: $7.0 million related to unvested stock options; $21.9 million related to unvested RSUs; and $29.1 million related to unvested RSAs (excludes performance-contingent RSAs).

 

Compensation Awards

 

The Company granted the following compensation awards:

 

		Three Months Ended March 31, 2012					Three Months Ended March 31, 2011
		Number of Compensation Awards Granted		Weighted- Average Exercise Price/Fair Value			Number of Compensation Awards Granted		Weighted- Average Exercise Price/Fair Value
2004 Plan
Stock options		118,000		$	19.05		94,000		$	22.12
RSUs time-based		468,541		18.12			394,580		24.59
RSAs time-based		402,500		18.11			1,148,000		24.70
RSAs performance-contingent(1)		44,500		18.11			1,290,000		24.73

 

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(1)                             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. 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 March 31, 2012, 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 2012, the Compensation Committee of the Company’s Board of Directors approved the grant of 44,500 performance-contingent RSAs to senior management. These grants are subject to forfeiture unless one of three possible performance goals is achieved by December 31, 2013.

 

Valuation Assumptions

 

The range of weighted-average assumptions used to estimate the fair value of stock options granted was as follows:

 

		Three Months Ended March 31,
		2012			2011
Employee stock options
Risk-free interest rate		1.00%-1.17		%	2.38%-2.46		%
Expected life (in years)		6			6
Volatility		0.55			0.49
Dividend yield		—		%	—		%
Weighted-average estimated fair value of stock options granted		$	9.88		$	10.86

 

Stockholders’ Equity

 

For the three months ended March 31, 2012, approximately 247,818 shares were exercised at a weighted-average exercise price of $8.13 per share, for total cash proceeds of approximately $2,015,000.

 

9. Income Taxes

 

The Company did not record a provision for income taxes for the three months ended March 31, 2012, because it is expected to generate a taxable net operating loss for the fiscal year ending December 31, 2012. In addition, the deferred tax assets continue to be treated as having no current value and remain fully reserved.

 

10. Subsequent Event

 

Sale of Stock

 

On April 2, 2012, the Company and GSK entered into a common stock purchase agreement, under which the Company will issue, and GSK will acquire, through an affiliate, 10,000,000 shares of the Company’s common stock at a price of $21.2887 per share, for a total investment of $212,887,000. This transaction is subject to certain closing conditions, including approval of the Company’s stockholders at the annual meeting of stockholders scheduled for May 15, 2012, and expiration of the waiting period under the Hart-Scott-Rodino Act. The agreement may be terminated (i) by GSK if, on any day before the closing of the private placement, the closing S&P 500 index is more than thirty percent (30%) less than the closing S&P 500 index on March 30, 2012, or the Company’s Board of Directors changes its recommendation to stockholders to vote in favor of the private placement or (ii) by either of the parties if a vote of the Company’s stockholders does not approve the private placement or if the private placement has not closed by July 15, 2012.

 

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Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

 

Forward-Looking Statements

 

The information in this discussion contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (Securities Act), and Section 21E of the Securities Exchange Act of 1934, as amended. Such forward-looking statements involve substantial risks, uncertainties and assumptions. All statements contained herein that are not of historical fact, including, without limitation, statements regarding our strategy, future operations, future financial position, future revenues, projected costs, prospects, plans, intentions, expectations, goals and objectives, may be forward-looking statements. The words “anticipates,” “believes,” “designed,” “estimates,” “expects,” “intends,” “may,” “objective,” “plans,” “projects,” “pursue,” “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 materially differ 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 of Part II and in “Management’s Discussion and Analysis of Financial Condition and Results of Operations” in this Item 2 of Part I. All forward-looking statements in this document are based on information available to us as of the date hereof and we assume no obligation to update any such forward-looking statements.

 

OVERVIEW

 

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 income was $84.6 million in the first quarter of 2012, compared with our net loss of $22.7 million for the same period in 2011. Net income in the three months ended March 31, 2012 reflects the recognition of deferred revenue of $125.7 million from our global collaboration arrangement with Astellas Pharma Inc. (Astellas) for the development and commercialization of VIBATIV®. This recognition resulted from Astellas’ January 6, 2012 termination of our agreement with them. Research and development expenses were $33.2 million for the three months ended March 31, 2012, compared with $20.5 million for the same period in 2011. This increase was driven primarily by higher external costs relating to ongoing clinical trials. Cash, cash equivalents, and short-term investments totaled $200.2 million at March 31, 2012, a decrease of $40.7 million since December 31, 2011. The decrease was due primarily to cash used in operations, partially offset by net proceeds of $2.0 million received from exercises of employee stock options and $1.6 million received from the sale of our common stock to an affiliate of GSK.

 

On April 2, 2012, we and GSK entered into a common stock purchase agreement, under which we will issue, and GSK will acquire, through an affiliate, 10,000,000 shares of our common stock at a price of $21.2887 per share, for a total investment of $212,887,000. This transaction is subject to certain closing conditions, including approval of our stockholders at the annual meeting of stockholders scheduled for May 15, 2012, and expiration of the waiting period under the Hart-Scott-Rodino Act.

 

Programs

 

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) and patients with asthma.

 

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During the first quarter of 2012, we and GSK announced the completion of the overall registrational program for RELOVAIR™ in COPD and asthma. In addition, results from two non-pivotal Phase 3 studies of RELOVAIR™ compared with twice-daily Advair® (fluticasone propionate (FP)/salmeterol (SAL) (FP/SAL)) in patients with COPD and results from a pivotal Phase 3 study evaluating the efficacy and safety of FF and FP compared to placebo in the treatment of persistent asthma in adults and adolescents were announced. For COPD, GSK continues with its plans to submit regulatory applications for RELOVAIR™ in the U.S. and Europe in mid-2012. For asthma, GSK plans to submit an application in Europe in mid-2012 and GSK and we are reviewing the strategy for a future U.S. filing. In March 2012, the Salford Lung Study, the first ‘real-world’ effectiveness study to investigate the potential effects of RELOVAIR™ versus the standards of care in Europe, was initiated in patients with COPD.

 

LAMA/LABA Combination (GSK573719/Vilanterol or ‘719/VI)

 

The Phase 3a program for the once-daily LAMA/LABA dual bronchodilator ‘719/VI is progressing well. We and GSK expect to report Phase 3a results from the LAMA/LABA program in 2012. ‘719/VI combines two bronchodilators currently under development: ‘719, a long-acting muscarinic antagonist (LAMA) and VI, a LABA. These molecules act through antagonism of acetylcholine muscarinic receptors and agonism of beta2 adrenoreceptors.

 

The LAMA/LABA Phase 3a program, which has enrolled 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 among ‘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 3a 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) is a single molecule bifunctional bronchodilator with both muscarinic antagonist and beta2 receptor agonist activity. In February 2012, we presented at Leerink Swann Healthcare Conference topline results from a Phase 2b efficacy and safety study of ‘081 administered once-daily (QD) or twice-daily (BID) to 436 patients with moderate to severe COPD for 28 days. The results of the Phase 2b study and a number of ongoing non-clinical enabling studies will inform the selection of the most appropriate dose and dosing interval for ‘081 and progression to Phase 3 will be dependent upon successful completion of these enabling studies.

 

Central Nervous System (CNS)/Pain Program

 

Oral Peripheral Mu Opioid Receptor Antagonist (PµMA) — TD-1211

 

Enrollment is complete in two of the three studies in the Phase 2b program, which will assess the safety, tolerability and clinical activity of TD-1211 in patients with opioid-induced constipation (OIC). This program is evaluating several doses and dosing 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

 

Enrollment is progressing in the Phase 2 proof-of-concept study with TD-9855 in patients with Attention-Deficit/Hyperactivity Disorder (ADHD), 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 adults with ADHD. TD-9855 is an investigational norepinephrine and serotonin reuptake inhibitor (NSRI) discovered by Theravance for the treatment of central nervous system (CNS) conditions such as ADHD and chronic pain.

 

Collaboration Arrangements

 

GSK

 

LABA collaboration

 

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™.

 

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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 had reported 2011 sales of approximately $8.1 billion, and to compete with Symbicort® (formoterol and budesonide as a combination), which had 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 had reported 2011 sales of approximately $4.2 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.

 

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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Common Stock Purchase Agreement, Purchases of Common Stock under our Governance Agreement and Conversion of our Class A Common Stock

 

On April 2, 2012, we and GSK entered into a stock purchase agreement, under which we will issue, and GSK will acquire, through an affiliate, 10,000,000 shares of our common stock at a price of $21.2887 per share, for a total investment of $212,887,000. This transaction is subject to certain closing conditions, including approval of our stockholders at the annual meeting of stockholders scheduled for May 15, 2012, and expiration of the waiting period under the Hart-Scott-Rodino Act. The agreement may be terminated (i) by GSK if, on any day before the closing of the private placement, the closing S&P 500 index is more than thirty percent (30%) less than the closing S&P 500 index on March 30, 2012, or our Board of Directors changes its recommendation to stockholders to vote in favor of the private placement or (ii) by either of the parties if a vote of our stockholders does not approve the private placement or if the private placement has not closed by July 15, 2012.

 

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:

 

		Through March 31, 2012
		Common Stock Shares Purchased		Aggregate Amounts (in millions)
Purchase dates
February 24, 2011		152,278		$	3.6
May 3, 2011		261,299		$	6.7
August 2, 2011		102,466		$	2.0
November 1, 2011		58,411		$	1.3
February 14, 2012		88,468		$	1.6

 

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.

 

GSK Upfront License Fees, Milestone Payments and Revenue

 

Revenue recognized from GSK under the LABA collaboration and strategic alliance agreement was as follows:

 

		Three Months Ended March 31,
(in millions)		2012			2011
LABA/RELOVAIR™ collaboration		$	0.9		$	1.3
Strategic alliance agreement		—			0.7
Strategic alliance—MABA program license		0.5			0.5
Total revenue		$	1.4		$	2.5

 

Astellas

 

License, Development and Commercialization Agreement with 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 previously granted to Astellas ceased upon termination of the agreement and Astellas stopped all promotional sales efforts. Pursuant to the terms of the agreement, Astellas is entitled to a ten-year, 2% royalty on future net sales of VIBATIV®. In March 2012, we entered into a series of agreements with Astellas for the purchase of VIBATIV® active pharmaceutical ingredient and raw materials of up to $6.2 million and VIBATIV® finished goods inventory of up to $4.2 million, which is subject to release by a third party manufacturer. In addition, beginning July 1, 2012, we are responsible to fund governmental rebate and governmental chargeback claims for Astellas-labeled product sales. As a result of the termination agreement, we recorded a liability of $150,000 at March 31, 2012, which is included in the condensed consolidated balance sheets. We are evaluating global commercialization alternatives for VIBATIV® either with partners or alone.

 

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VIBATIV® (telavancin) is 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. We have begun identifying possible alternative manufacturers for VIBATIV® drug product. The process of identifying and qualifying an alternative manufacturer could take 12 to 24 months.

 

Through January 6, 2012, we had received $191.0 million in upfront license, milestone and other fees from Astellas. We previously recorded these payments as deferred revenue and amortized them ratably over the estimated performance period (development and commercialization period). As a result of the termination of the VIBATIV® collaboration agreement, the development and commercialization period ended on January 6, 2012. As such, we recognized into revenue $125.8 million of deferred revenue related to Astellas in the three months ended March 31, 2012, and we are no longer eligible to receive any further milestone payments from Astellas.

 

Net revenue recognized under this collaboration agreement was as follows:

 

		Three Months Ended March 31,
(in millions)		2012			2011
Recognition of deferred revenue		$	125.8		$	3. 2
Royalties from net sales of VIBATIV®		—			0.6
Astellas-labeled product sales allowance		(0.1		)	—
Total net revenue		$	125.7		$	3.8

 

Critical Accounting Policies and the Use of Estimates

 

As of the date of the filing of this quarterly report, we believe there have been no material changes or additions to our critical accounting policies and estimates during the three months ended March 31, 2012 compared to those discussed in our 2011 Annual Report on Form 10-K filed on February 27, 2012.

 

RESULTS OF OPERATIONS

 

Revenue

 

Revenue, as compared to the prior year period, was as follows:

 

		Three Months Ended March 31,						Change
(in millions, except percentages)		2012			2011			$			%
Revenue		$	127.1		$	6.3		$	120.8		1917	%

 

We recognized 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 $127.1 million in the first quarter of 2012, from the comparable period in 2011. This increase reflects the accelerated recognition of deferred revenue of $125.7 million from our global collaboration arrangement with Astellas for the development and commercialization of VIBATIV®. This recognition resulted from Astellas’ January 6, 2012 termination of our agreement with them. This increase was partially offset by a decrease in revenue related to our GSK strategic alliance agreement of $0.7 million resulting from the deferred revenue being fully amortized in the third quarter of 2011.

 

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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:

 

		Through March 31, 2012
(in millions)		Upfront License and Other Fees			Milestone Payments			Total
GSK Collaborations
LABA/RELOVAIR™ collaboration(1)		$	10.0		$	50.0		$	60.0
Strategic alliance agreement		20.0			—			20.0
Strategic alliance—LAMA license(2)		5.0			3.0			8.0
Strategic alliance—MABA program license		6.0			16.0			22.0
Astellas License agreement(3)		70.0			121.0			191.0
Total		$	111.0		$	190.0		$	301.0

(1)                                 We do not currently expect to be eligible for any additional milestones under this collaboration.

 

(2)                                 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.

 

(3)                                 This agreement was terminated on January 6, 2012.

 

Upfront fees and certain milestone payments received from GSK have been deferred and are being amortized ratably into revenue over the estimated performance period. Future revenue will include the ongoing amortization of upfront and milestone payments earned. We periodically review and, if necessary, revise the estimated periods of our performance pursuant to these contracts.

 

Research & Development

 

Research and development expenses, as compared to the prior year period, were as follows:

 

		Three Months Ended March 31,						Change
(in millions, except percentages)		2012			2011			$			%
Employee-related		$	10.2		$	8.3		$	1.9		23	%
External research and development		13.2			3.2			10.0			313	%
Stock-based compensation		3.5			3.1			0.4			13	%
Facilities, depreciation and other allocated		6.3			5.9			0.4			7	%
Total research and development expenses		$	33.2		$	20.5		$	12.7		62	%

 

R&D expenses increased in the first quarter of 2012, compared to the same period in 2011. The increase in the first quarter of 2012 was due primarily to Phase 2 clinical costs related to our PµMA and MARIN programs, costs related to our preclinical and late-stage discovery programs, and higher employee-related expenses.

 

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, preclinical and 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 and administrative

 

General and administrative expenses, as compared to the prior year period, were as follows:

 

		Three Months Ended March 31,						Change
(in millions, except percentages)		2012			2011			$			%
General and administrative		$	7.9		$	7.2		$	0.7		10	%

 

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G&A expenses increased in the first quarter of 2012, compared to same period in 2011. The increase in the first quarter of 2012 was due primarily to higher external legal and professional services costs in connection with the evaluation of global commercialization alternatives related to VIBATIV® and higher employee-related expenses, including stock-based compensation expense, partially offset by lower facilities-related costs.  Stock-based compensation expense for the first quarter of 2012 was $2.7 million compared with $2.4 million for the same period in 2011.

 

We anticipate G&A expenses for 2012 to increase slightly relative to 2011, due to the transfer of certain ongoing VIBATIV® related activities following the termination by Astellas of the collaboration agreement in January 2012.

 

Interest income

 

Interest income, as compared to the prior year period, was as follows:

 

		Three Months Ended March 31,						Change
(in millions, except percentages)		2012			2011			$			%
Interest income		$	0.1		$	0.1		$	—		—	%

 

Interest income remained flat in the first quarter of 2012, compared to the same period in 2011.

 

Interest expense

 

Interest expense, as compared to the prior year period, was as follows:

 

		Three Months Ended March 31,						Change
(in millions, except percentages)		2012			2011			$			%
Interest expense		$	1.5		$	1.5		$	—		—	%

 

Interest expense is primarily comprised of interest expense and amortization of debt issuance costs from our convertible subordinated notes issued in January 2008.

 

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 March 31, 2012, we had $200.2 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. On April 2, 2012, we and GSK entered into a stock purchase agreement, under which we will issue, and GSK will acquire, through an affiliate, 10,000,000 shares of our common stock at a price of $21.2887 per share, for a total investment of $212,887,000. This stock purchase is subject to certain closing conditions, including approval of our stockholders at the annual meeting of stockholders scheduled for May 15, 2012, and expiration of the waiting period under the Hart-Scott-Rodino Act. Further, if the closing S&P 500 index is more than thirty percent (30%) less than the closing S&P 500 index on March 30, 2012, then GSK will have the option not to consummate the private placement.

 

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 programs in earlier-stage clinical development and late-stage discovery. On January 6, 2012, Astellas exercised its right to terminate our collaboration agreement for VIBATIV®. In March 2012, we entered into a series of purchase agreements for VIBATIV® active pharmaceutical ingredient and raw materials of up to $6.2 million and VIBATIV® finished goods inventory of up to $4.2 million, which is subject to release of the inventory by a third party manufacturer.

 

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