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Table of Contents

 

 

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

 

¨ 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: 001-34186

 

 

VANDA PHARMACEUTICALS INC.

(Exact name of registrant as specified in its charter)

 

 

 

Delaware   03-0491827

(State or other jurisdiction of

incorporation or organization)

 

(I.R.S. Employer

Identification No.)

2200 Pennsylvania Avenue, Suite 300 E

Washington, D.C.

  20037
(Address of principal executive offices)   (Zip Code)

(202) 734-3400

(Registrant’s telephone number, including area code)

9605 Medical Center Drive, Suite 300

Rockville, Maryland

(Former address, if changed since last report)

 

 

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  ¨

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  ¨

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

 

Large accelerated filer   ¨    Accelerated filer   x
Non-accelerated filer   ¨  (Do not check if a smaller reporting company)    Smaller reporting company   ¨

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

As of May 4, 2012, there were 28,226,743 shares of the registrant’s common stock issued and outstanding.

 

 

 


Table of Contents

Vanda Pharmaceuticals Inc.

Quarterly Report on Form 10-Q

For the Quarter Ended March 31, 2012

INDEX

 

          Page  
PART I — FINANCIAL INFORMATION   

ITEM 1.

  

Financial Statements (Unaudited):

     3   
  

Condensed Consolidated Balance Sheets at 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 for the three months ended March 31, 2012 and 2011

     5   
  

Condensed Consolidated Statement of Changes in Stockholders’ Equity for the three months ended March 31, 2012

     6   
  

Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2012 and 2011

     7   
  

Notes to Condensed Consolidated Financial Statements

     8   

ITEM 2.

  

Management’s Discussion and Analysis of Financial Condition and Results of Operations

     22   

ITEM 3.

  

Quantitative and Qualitative Disclosures about Market Risk

     31   

ITEM 4.

  

Controls and Procedures

     31   
PART II — OTHER INFORMATION   

ITEM 1.

  

Legal Proceedings

     32   

ITEM 1A.

  

Risk Factors

     32   

ITEM 2.

  

Unregistered Sales of Equity Securities and Use of Proceeds

     32   

ITEM 3.

  

Defaults Upon Senior Securities

     32   

ITEM 4.

  

Mine Safety Disclosures

     32   

ITEM 5.

  

Other Information

     32   

ITEM 6.

  

Exhibits

     32   

Signatures

     33   

Exhibits

     34   

 

2


Table of Contents

Part I — FINANCIAL INFORMATION

 

Item 1. Financial Statements (Unaudited).

VANDA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited)

 

     March 31,
2012
    December 31,
2011
 
(in thousands, except for share and per share amounts)             
ASSETS   

Current assets:

    

Cash and cash equivalents

   $ 108,094      $ 87,923   

Marketable securities, current

     49,156        60,961   

Accounts receivable

     1,535        1,618   

Prepaid expenses, deposits and other current assets

     2,564        2,999   
  

 

 

   

 

 

 

Total current assets

     161,349        153,501   

Marketable securities, non-current

     —          19,012   

Property and equipment, net

     2,478        964   

Other assets, non-current

     84        84   

Intangible asset, net

     7,658        8,027   

Restricted cash

     1,030        1,030   
  

 

 

   

 

 

 

Total assets

   $ 172,599      $ 182,618   
  

 

 

   

 

 

 
LIABILITIES AND STOCKHOLDERS’ EQUITY   

Current liabilities:

    

Accounts payable

   $ 780      $ 996   

Accrued liabilities, current

     5,093        3,381   

Deferred rent, current

     —          453   

Deferred revenues, current

     26,789        26,789   
  

 

 

   

 

 

 

Total current liabilities

     32,662        31,619   

Accrued liabilities, non-current

     278        —     

Deferred rent, non-current

     2,281        461   

Deferred revenues, non-current

     110,458        117,064   
  

 

 

   

 

 

 

Total liabilities

     145,679        149,144   

Commitments

    

Stockholders’ equity:

    

Preferred stock, $0.001 par value; 20,000,000 shares authorized and none issued and outstanding

     —          —     

Common stock, $0.001 par value; 150,000,000 shares authorized, 28,226,743 and 28,117,026 shares issued and outstanding as of March 31, 2012 and December 31, 2011, respectively

     28        28   

Additional paid-in capital

     298,270        296,868   

Accumulated other comprehensive income

     27        21   

Accumulated deficit

     (271,405     (263,443
  

 

 

   

 

 

 

Total stockholders’ equity

     26,920        33,474   
  

 

 

   

 

 

 

Total liabilities and stockholders’ equity

   $ 172,599      $ 182,618   
  

 

 

   

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

3


Table of Contents

VANDA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited)

 

     Three Months Ended  
(in thousands, except for share and per share amounts)    March 31,
2012
    March 31,
2011
 

Revenues:

    

Licensing agreement

   $ 6,606      $ 6,606   

Royalty revenue

     1,535        895   
  

 

 

   

 

 

 

Total revenues

     8,141        7,501   
  

 

 

   

 

 

 

Operating expenses:

    

Research and development

     12,180        4,267   

General and administrative

     3,909        2,858   

Intangible asset amortization

     369        369   
  

 

 

   

 

 

 

Total operating expenses

     16,458        7,494   
  

 

 

   

 

 

 

Income (loss) from operations

     (8,317     7   

Other income

     355        135   
  

 

 

   

 

 

 

Income (loss) before tax provision

     (7,962     142   

Tax provision

     —          6   
  

 

 

   

 

 

 

Net income (loss)

   $ (7,962   $ 136   
  

 

 

   

 

 

 

Net income (loss) per share:

    

Basic

   $ (0.28   $ 0.00   
  

 

 

   

 

 

 

Diluted

   $ (0.28   $ 0.00   
  

 

 

   

 

 

 

Shares used in calculation of net income (loss) per share:

    

Basic

     28,226,743        28,101,418   
  

 

 

   

 

 

 

Diluted

     28,226,743        28,936,835   
  

 

 

   

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

4


Table of Contents

VANDA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE INCOME (Unaudited)

 

     Three Months Ended  
(in thousands)    March 31,
2012
    March 31,
2011
 

Net income (loss)

   $ (7,962   $ 136   

Other comprehensive income (loss)

    

Change in net unrealized gain (loss) on marketable securities

     6        97   
  

 

 

   

 

 

 

Other comprehensive income (loss) before tax provision

     (7,956     233   
  

 

 

   

 

 

 

Tax provision related to other comprehensive income (loss)

     —          —     
  

 

 

   

 

 

 

Comprehensive income (loss)

   $ (7,956   $ 233   
  

 

 

   

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

5


Table of Contents

VANDA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED STATEMENT OF CHANGES IN STOCKHOLDERS’ EQUITY (Unaudited)

 

                          Accumulated               
                   Additional      Other               
     Common Stock      Paid-In
Capital
     Comprehensive
Income
     Accumulated
Deficit
    Total  
(in thousands, except for share amounts)    Shares      Par Value             

Balances at December 31, 2011

     28,117,026       $ 28       $ 296,868       $ 21       $ (263,443   $ 33,474   

Issuance of common stock from exercised stock options and settlement of restricted stock units

     109,717         —           —           —           —          —     

Employee and non-employee stock-based compensation

     —           —           1,402         —           —          1,402   

Net loss

     —           —           —           —           (7,962     (7,962

Other comprehensive income

     —           —           —           6         —          6   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

Balances at March 31, 2012

     28,226,743       $ 28       $ 298,270       $ 27       $ (271,405   $ 26,920   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

   

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

6


Table of Contents

VANDA PHARMACEUTICALS INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited)

 

     Three Months Ended  
(in thousands)    March 31,
2012
    March 31,
2011
 

Cash flows from operating activities

    

Net income (loss)

   $ (7,962   $ 136   

Adjustments to reconcile net income (loss) to net cash used in operating activities:

    

Depreciation

     331        77   

Employee and non-employee stock-based compensation

     1,402        1,604   

Amortization of premiums and discounts on marketable securities

     117        315   

Amortization of intangible asset

     369        369   

Changes in assets and liabilities:

    

Accounts receivable

     83        (384

Prepaid expenses, deposits and other assets

     435        224   

Accounts payable

     (216     186   

Accrued liabilities, current

     1,712        817   

Accrued liabilities, non-current

     278        —     

Accrued income taxes

     —          6   

Other liabilities

     (361     (8

Landlord contributions for tenant improvements

     1,728        —     

Deferred revenue

     (6,606     (6,606
  

 

 

   

 

 

 

Net cash used in operating activities

     (8,690     (3,264

Cash flows from investing activities

    

Purchases of property and equipment

     (1,845     —     

Purchases of marketable securities

     (29,194     (47,400

Maturities of marketable securities

     59,900        60,625   
  

 

 

   

 

 

 

Net cash provided by investing activities

     28,861        13,225   

Net change in cash and cash equivalents

     20,171        9,961   

Cash and cash equivalents

    

Beginning of period

     87,923        42,559   
  

 

 

   

 

 

 

End of period

   $ 108,094      $ 52,520   
  

 

 

   

 

 

 

The accompanying notes are an integral part of these unaudited condensed consolidated financial statements.

 

7


Table of Contents

VANDA PHARMACEUTICALS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited)

 

1. Business Organization and Presentation

Business organization

Vanda Pharmaceuticals Inc. (Vanda or the Company) is a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders. Vanda commenced its operations in 2003. The Company’s lead product, Fanapt® (iloperidone), which Novartis Pharma AG (Novartis) began marketing in the U.S. in the first quarter of 2010, is a compound for the treatment of schizophrenia. On May 6, 2009, the U.S. Food and Drug Administration (FDA) granted U.S. marketing approval of Fanapt® for the acute treatment of schizophrenia in adults. On October 12, 2009, Vanda entered into an amended and restated sublicense agreement with Novartis. Vanda had originally entered into a sublicense agreement with Novartis on June 4, 2004 pursuant to which Vanda obtained certain worldwide exclusive licenses from Novartis relating to Fanapt®. Pursuant to the amended and restated sublicense agreement, Novartis has exclusive commercialization rights to all formulations of Fanapt® in the U.S. and Canada. Novartis is responsible for the further clinical development activities in the U.S. and Canada, including the development of a long-acting injectable (or depot) formulation of Fanapt®. Pursuant to the amended and restated sublicense agreement, Vanda received an upfront payment of $200.0 million at the end of 2009 and is eligible for additional payments totaling up to $265.0 million upon the achievement of certain commercial and development milestones for Fanapt® in the U.S. and Canada. Vanda also receives royalties, which, as a percentage of net sales, are in the low double-digits, on net sales of Fanapt® in the U.S. and Canada. In addition, Vanda is no longer required to make any future milestone payments with respect to sales of Fanapt® or any future royalty payments with respect to sales of Fanapt® in the U.S. and Canada. Vanda retains exclusive rights to Fanapt® outside the U.S. and Canada and Vanda has exclusive rights to use any of Novartis’ data for Fanapt® for developing and commercializing Fanapt® outside the U.S. and Canada. At Novartis’ option, Vanda will enter into good faith discussions with Novartis relating to the co-commercialization of Fanapt® outside of the U.S. and Canada or, alternatively, Novartis will receive a royalty on net sales of Fanapt® outside of the U.S. and Canada. Novartis has chosen not to co-commercialize Fanapt® with Vanda in Europe and certain other countries and will instead receive a royalty on net sales in those countries. These include, but are not limited to, the countries in the European Union, as well as Switzerland, Norway, Liechtenstein and Iceland. Vanda continues to explore the regulatory path and commercial opportunity for Fanapt® oral formulation outside of the U.S. and Canada. On July 22, 2011, the European Medicines Agency (EMA) notified Vanda that it had accepted for evaluation the Marketing Authorization Application (MAA) for oral iloperidone tablets. Vanda has received the initial list of comments from the EMA and has been granted a three-month extension of the review cycle in order to better prepare its responses to these comments. Vanda has entered into agreements with the following partners for the commercialization of Fanapt® in the countries set forth below:

 

Country

  

Partner

Mexico    Probiomed S.A. de C.V.
Argentina    Biotoscana Farma S.A.
Israel    Megapharm Ltd.

Tasimelteon is an oral compound in development for the treatment of sleep and mood disorders including Circadian Rhythm Sleep Disorders (CRSD). On January 19, 2010, the FDA granted orphan drug designation status for tasimelteon in a specific CRSD, Non-24-Hour Disorder (N24HD) in blind individuals without light perception. The FDA grants orphan drug designation to drugs that may provide significant therapeutic advantage over existing treatments and target conditions affecting 200,000 or fewer U.S. patients per year. Orphan drug designation provides potential financial and regulatory incentives including, study design assistance, waiver of FDA user fees, tax credits, and up to seven years of market exclusivity upon marketing approval. On February 23, 2011, the European Commission (EC) designated tasimelteon as an orphan medicinal product for the same indication. Vanda has initiated four clinical trials to pursue FDA approval of tasimelteon for the treatment of N24HD in blind individuals without light perception. Two of the clinical trials were initiated in the third quarter of 2010, the third was initiated in the third quarter of 2011 and the fourth was initiated in the fourth quarter of 2011. The first clinical trial (SET-3201) is a randomized, double-blind, placebo-controlled study with a planned enrollment of approximately 100 patients with N24HD. The trial has a six month treatment period and includes measures of both nighttime and daytime sleep, as well as laboratory measures of the synchronization between the internal body clock and the 24-hour environmental light/dark cycle. The second clinical trial (3202) is a one-year safety study of tasimelteon for the treatment of N24HD. This trial is an open-label safety study with a planned enrollment of up to 140 patients with N24HD. The third clinical trial (RESET-3203) is a placebo-controlled, randomized withdrawal study to examine the maintenance effect of tasimelteon for the treatment of N24HD with a planned enrollment of up to 20 patients with N24HD. Patients will be observed for 12 weeks during which nighttime and daytime sleep, as well as synchronization of their internal body clock to the 24-hour day, will continue to be evaluated. The fourth clinical trial (3204) is a two-year open-label, multicenter, study in blind subjects with N24HD

 

8


Table of Contents

VANDA PHARMACEUTICALS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) – (continued)

 

to assess the safety of tasimelteon. Vanda expects to complete the two Phase III efficacy studies, SET and RESET, by the end of 2012. The tasimelteon N24HD program continues to advance towards its goal of a projected mid-2013 NDA filing with the FDA. Vanda is in continuing discussions with the FDA to confirm the path and requirements for this regulatory submission. In the third quarter of 2011, Vanda initiated a Phase IIb/III clinical trial (MAGELLAN-2301) to study the efficacy of tasimelteon for the treatment of Major Depressive Disorder (MDD). The clinical trial is a randomized, double-blind, placebo-controlled study with a planned enrollment of approximately 500 patients with MDD. The trial has an eight-week treatment period, followed by an optional one-year open-label extension, and includes measures of depression and anxiety symptoms, nighttime and daytime sleep, as well as laboratory measures of the internal body clock. Given the range of potential indications for tasimelteon, Vanda may pursue one or more partnerships for the development and commercialization of tasimelteon worldwide.

Throughout this quarterly report on Form 10-Q, Vanda refers to Fanapt® within the U.S. and Canada as its partnered product and Vanda refers to Fanapt® outside the U.S. and Canada and tasimelteon as its products. All other compounds are referred to as Vanda’s product candidates. In addition, Vanda refers to its partnered products, products and product candidates collectively as its compounds. Moreover, Vanda refers to drug products generally as drugs or products.

Basis of presentation

The accompanying unaudited condensed consolidated financial statements 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 the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s consolidated financial statements for the year ended December 31, 2011 included in the Company’s annual report on Form 10-K. The financial information as of March 31, 2012 and for the three months ended March 31, 2012 and 2011, is unaudited, but in the opinion of management, all adjustments, consisting only of normal recurring accruals, considered necessary for a fair statement of the results of these interim periods have been included. The condensed consolidated balance sheet data as of December 31, 2011 was derived from audited financial statements but does not include all disclosures required by GAAP.

The results of the Company’s operations for any interim period are not necessarily indicative of the results that may be expected for any other interim period or for a full fiscal year. The financial information included herein should be read in conjunction with the consolidated financial statements and notes in the Company’s Annual Report on Form 10-K for the year ended December 31, 2011.

 

2. Summary of Significant Accounting Policies

Use of estimates

The preparation of financial statements in conformity with GAAP requires management to make estimates that affect the reported amounts of assets and liabilities at the date of the financial statements, disclosure of contingent assets and liabilities, and the reported amounts of revenue and expenses during the reporting period. Actual results could differ from those estimates.

Cash and cash equivalents

For purposes of the condensed consolidated balance sheets and condensed consolidated statements of cash flows, cash equivalents represent highly-liquid investments with a maturity date of three months or less at the date of purchase.

Marketable securities

The Company classifies all of its marketable securities as available-for-sale securities. The Company’s investment policy requires the selection of high-quality issuers, with bond ratings of AAA to A1+/P1. Available-for-sale securities are carried at fair market value, with unrealized gains and losses reported as a component of stockholders’ equity in accumulated other comprehensive income/loss. Interest and dividend income is recorded when earned and included in interest income. Premiums and discounts on marketable securities are amortized and accreted, respectively, to maturity and included in interest income. The Company uses the specific identification method in computing realized gains and losses on the sale of investments, which would be included in the condensed consolidated statements of operations when generated. Marketable securities with a maturity of more than one year as of the balance sheet date, and for which the Company does not intend to sell within the next twelve months are classified as non-current. All other marketable securities are classified as current.

Intangible asset, net

Costs incurred for products or product candidates not yet approved by the FDA and for which no alternative future use exists are recorded as expense. In the event a product or product candidate has been approved by the FDA or an alternative future use exists for a product or product candidate, patent and license costs are capitalized and amortized over the expected patent life of the related product or product candidate. Milestone payments to the Company’s partners are recognized when it is deemed probable that the milestone event will occur.

 

9


Table of Contents

VANDA PHARMACEUTICALS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) – (continued)

 

As a result of the FDA’s approval of the NDA for Fanapt® in May 2009, the Company met a milestone under its original sublicense agreement with Novartis which required the Company to make a payment of $12.0 million to Novartis. The $12.0 million is being amortized on a straight line basis over the remaining life of the U.S. patent for Fanapt®, which the Company expects to last until May 2017. This includes the Hatch-Waxman extension that extends patent protection for drug compounds for a period of up to five years to compensate for time spent in development and a six-month pediatric term extension. Fanapt® has qualified for the full five-year patent term Hatch-Waxman extension and the Company expects that Fanapt® will be eligible for six months of pediatric exclusivity. This term is the Company’s best estimate of the life of the patent; if, however, the pediatric extension is not granted, the intangible asset will be amortized over a shorter period.

The carrying values of intangible assets are periodically reviewed to determine if the facts and circumstances suggest that a potential impairment may have occurred. The Company had no impairments of its intangible assets for the three months ended March 31, 2012.

Property and equipment

Property and equipment are stated at cost less accumulated depreciation and amortization. Depreciation of property and equipment is provided on a straight-line basis over the estimated useful lives of the assets. Amortization of leasehold improvements is provided on a straight-line basis over the shorter of their estimated useful life or the lease term. The costs of additions and improvements are capitalized, and repairs and maintenance costs are charged to operations in the period incurred. Upon retirement or disposition of property and equipment, the cost and accumulated depreciation and amortization are removed from the accounts and any resulting gain or loss is reflected in the Company’s statement of operations for that period.

Revenue Recognition

The Company’s revenues are derived primarily from the amended and restated sublicense agreement with Novartis and include an upfront payment, product sales and future milestone and royalty payments. Revenue is considered both realizable and earned when each one of the following four conditions is met: (1) persuasive evidence of an arrangement exists, (2) the arrangement fee is fixed or determinable, (3) delivery or performance has occurred and (4) collectability is reasonably assured. Pursuant to the amended and restated sublicense agreement, Novartis has the right to commercialize and develop Fanapt® in the U.S. and Canada. Under the amended and restated sublicense agreement, the Company received an upfront payment of $200.0 million in December of 2009. Pursuant to the amended and restated sublicense agreement, the Company and Novartis established a Joint Steering Committee (JSC) following the effective date of the amended and restated sublicense agreement. The Company expects to have an active role on the JSC and concluded that the JSC constitutes a deliverable under the amended and restated sublicense agreement and that revenue related to the upfront payment will be recognized ratably over the term of the JSC; however, the delivery or performance has no term as the exact length of the JSC is undefined. As a result, the Company deems the performance period of the JSC to be the life of the U.S. patent of Fanapt®, which the Company expects to last until May 2017. This includes the Hatch-Waxman extension that provides patent protection for drug compounds for a period of five years to compensate for time spent in development and a six-month pediatric term extension. Fanapt® has qualified for the full five-year patent term Hatch-Waxman extension and the Company expects that Fanapt® will be eligible for six months of pediatric exclusivity. This term is the Company’s best estimate of the life of the patent. Revenue related to the upfront payment will be recognized ratably from the date the amended and restated sublicense agreement became effective (November 27, 2009) through the expected life of the U.S. patent for Fanapt® (May 2017). The Company recognizes revenue from Fanapt® royalties and commercial and development milestones from Novartis when realizable and earned.

Concentrations of credit risk

Financial instruments which potentially subject the Company to significant concentrations of credit risk consist primarily of cash, cash equivalents and marketable securities. The Company places its cash, cash equivalents and marketable securities with what the Company believes to be highly-rated financial institutions. At March 31, 2012, the Company maintained all of its cash, cash equivalents and marketable securities in two financial institutions. Deposits held with these institutions may exceed the amount of insurance provided on such deposits. Generally, these deposits may be redeemed upon demand, and the Company believes there is minimal risk of losses on such balances.

 

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VANDA PHARMACEUTICALS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) – (continued)

 

Accrued expenses

The Company’s management is required to estimate accrued expenses as part of the process of preparing financial statements. The estimation of accrued expenses involves identifying services that have been performed on the Company’s behalf, and then estimating the level of service performed and the associated cost incurred for such services as of each balance sheet date in the financial statements. Accrued expenses include professional service fees, such as lawyers and accountants, contract service fees, such as those under contracts with clinical monitors, data management organizations and investigators in conjunction with clinical trials, fees to contract manufacturers in conjunction with the production of clinical materials, and fees for marketing and other commercialization activities. Pursuant to management’s assessment of the services that have been performed on clinical trials and other contracts, the Company recognizes these expenses as the services are provided. Such management assessments include, but are not limited to: (1) an evaluation by the project manager of the work that has been completed during the period, (2) measurement of progress prepared internally and/or provided by the third-party service provider, (3) analyses of data that justify the progress, and (4) the Company’s management’s judgment. In the event that the Company does not identify certain costs that have begun to be incurred or the Company under- or over-estimates the level of services performed or the costs of such services, the Company’s reported expenses for such period would be too low or too high. 

Research and development expenses

The Company’s research and development expenses consist primarily of fees for services provided by third parties in connection with the clinical trials, costs of contract manufacturing services, milestone license fees, costs of materials used in clinical trials and research and development, costs for regulatory consultants and filings, depreciation of capital resources used to develop products, related facilities costs, and salaries, other employee related costs and stock-based compensation for the Company’s research and development personnel. The Company expenses research and development costs as they are incurred for compounds in the development stage, including certain payments made under the license agreements prior to FDA approval. Prior to FDA approval, all Fanapt® manufacturing-related and milestone license payments were included in research and development expenses. Subsequent to FDA approval of Fanapt®, manufacturing and milestone license payments related to this product have been capitalized. Costs related to the acquisition of intellectual property have been expensed as incurred since the underlying technology associated with these acquisitions were made in connection with the Company’s research and development efforts and have no alternative future use. Milestone license payments are accrued in accordance with the FASB guidance on accounting for contingencies which states that milestone payments be accrued when it is deemed probable that the milestone event will be achieved.

General and administrative expenses

General and administrative expenses consist primarily of salaries, other employee related costs and stock-based compensation for personnel serving executive, business development, marketing, finance, accounting, information technology, marketing and human resource functions, facility costs not otherwise included in research and development expenses, insurance costs and professional fees for legal, accounting and other professional services. General and administrative expenses also include third party expenses incurred to support business development, marketing and other business activities related to Fanapt®.

Employee stock-based compensation

The Company accounts for its stock-based compensation expenses in accordance with the FASB guidance on share-based payments which was adopted on January 1, 2006. Accordingly, compensation costs for all stock-based awards to employees and directors are measured based on the grant date fair value of those awards and recognized over the period during which the employee or director is required to perform service in exchange for the award. The Company generally recognizes the expense over the award’s vesting period.

The fair value of stock options granted is amortized using the accelerated attribution method. The fair value of restricted stock units (RSUs) awarded is amortized using the straight line method. As stock-based compensation expense recognized in the consolidated statements of operations is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. Forfeitures are required to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. Pre-vesting forfeitures on the options granted prior to 2009 were estimated to be approximately 2%. The forfeiture rate was increased to 4% in 2009 based on the Company’s historical experience and this rate has been utilized for all subsequently granted options.

 

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VANDA PHARMACEUTICALS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) – (continued)

 

Total employee stock-based compensation expense recognized during the three months ended March 31, 2012 and 2011 was comprised of the following:

 

     Three Months Ended  
(in thousands)    March 31,
2012
     March 31,
2011
 

Research and development

   $ 593       $ 720   

General and administrative

     798         878   
  

 

 

    

 

 

 

Stock-based compensation expense

   $ 1,391       $ 1,598   
  

 

 

    

 

 

 

As of March 31, 2012, $7.3 million of total unrecognized compensation costs related to non-vested awards are expected to be recognized over a weighted average period of 1.39 years.

As of March 31, 2012, the Company had two equity incentive plans, the Second Amended and Restated Management Equity Plan (the 2004 Plan) and the 2006 Equity Incentive Plan (the 2006 Plan) that were adopted in December 2004 and April 2006, respectively. An aggregate of 677,145 shares were subject to outstanding options granted under the 2004 Plan as of March 31, 2012, and no additional options will be granted under this plan. As of March 31, 2012, there were 7,866,260 shares of the Company’s common stock reserved under the 2006 Plan of which 4,763,454 shares were subject to outstanding options and RSUs issued to employees and non-employees.

Options are subject to terms and conditions established by the compensation committee of the board of directors. None of the stock-based awards are classified as a liability as of March 31, 2012. Option awards have 10-year contractual terms and all options granted prior to December 31, 2006, options granted to new employees, and certain options granted to existing employees vest and become exercisable on the first anniversary of the grant date with respect to 25% of the shares subject to the option awards. The remaining 75% of the shares subject to the option awards vest and become exercisable monthly in equal installments thereafter over three years. Certain option awards granted to existing employees after December 31, 2006 vest and become exercisable monthly in equal installments over four years. The initial stock options granted to directors upon their election vest and become exercisable in equal monthly installments over a period of four years, while the subsequent annual stock option grants to directors vest and become exercisable in equal monthly installments over a period of one year. Certain option awards to executives and directors provide for accelerated vesting if there is a change in control of the Company. Certain option awards to employees and executives provide for accelerated vesting if the respective employee’s or executive’s service is terminated by the Company for any reason other than cause or permanent disability. As of March 31, 2012, there were $3.8 million of total unrecognized compensation costs related to unvested option awards granted under the Company’s stock incentive plans.

The fair value of each option award is estimated on the date of grant using the Black-Scholes-Merton option pricing model that uses the assumptions noted in the following table. Due to the limited historic information on the Company’s publicly traded common stock, expected volatility rates are based on the historical volatility of the Company’s publicly traded common stock blended with the historical volatility of the common stock of comparable entities. The expected term of options granted is based on the transition approach provided by FASB guidance as the options meet the “plain vanilla” criteria required by this guidance. The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. The Company has not paid dividends to its stockholders since its inception (other than a dividend of preferred share purchase rights which was declared on September 25, 2008) and does not plan to pay dividends in the foreseeable future.

Assumptions used in the Black-Scholes-Merton option pricing model for employee and director stock options granted during the three months ended March 31, 2012 and 2011 were as follows:

 

     Three Months Ended  
     March 31,
2012
    March 31,
2011
 

Expected dividend yield

     0     0

Weighted average expected volatility

     73     73

Weighted average expected term (years)

     6.03        6.03   

Weighted average risk-free rate

     1.11     2.46

 

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VANDA PHARMACEUTICALS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) – (continued)

 

A summary of option activity for the 2004 Plan as of March 31, 2012, and changes during the three months then ended is presented below:

 

(in thousands, except for share and per share amounts)    Number of
Shares
     Weighted
Average
Exercise Price at
Grant Date
     Weighted Average
Remaining Term
(Years)
     Aggregate Intrinsic
Value
 

Outstanding at December 31, 2011

     677,145       $ 1.78         3.78       $ 2,016   

Exercised

     —           —           

Forfeited

     —           —           

Cancelled

     —           —           
  

 

 

          

Outstanding at March 31, 2012

     677,145       $ 1.78         3.53       $ 2,036   
  

 

 

          

Exercisable at March 31, 2012

     677,145       $ 1.78         3.53       $ 2,036   
  

 

 

          

A summary of option activity for the 2006 Plan as of March 31, 2012, and changes during the three months then ended is presented below:

 

(in thousands, except for share and per share amounts)    Number of
Shares
    Weighted
Average
Exercise Price at
Grant Date
     Weighted Average
Remaining Term
(Years)
     Aggregate Intrinsic
Value
 

Outstanding at December 31, 2011

     4,254,681      $ 12.16         7.65       $ 396   

Granted

     17,000      $ 7.05         

Exercised

     —          —           

Forfeited

     —          —           

Cancelled

     (25,541   $ 6.85         
  

 

 

         

Outstanding at March 31, 2012

     4,246,140      $ 12.18         7.40       $ 400   
  

 

 

         

Exercisable at March 31, 2012

     2,541,466      $ 15.26         6.44       $ 340   
  

 

 

         

The weighted average grant-date fair value of options granted during the three months ended March 31, 2012 was $4.41 per share. For the three months ended March 31, 2012 and 2011, the amounts received by the Company in cash from options exercised under the stock-based arrangements were not material.

A RSU is a stock award that entitles the holder to receive shares of the Company’s common stock as the award vests. The fair value of each RSU is based on the closing price of the Company’s stock on the date of grant which equals the RSUs intrinsic value. As of March 31, 2012, there was $3.5 million of total unrecognized compensation cost related to unvested RSU awards granted under the Company’s stock incentive plans.

A summary of RSU activity for the 2006 Plan as of March 31, 2012, and changes during the three months then ended is presented below:

 

(in thousands, except for share and per share amounts)    Number of
Shares
    Weighted Average
Price/Share
     Aggregate
Intrinsic Value
 

Unvested at December 31, 2011

     522,346      $ 7.43       $ 2,486   

Granted

     1,000      $ 4.56      

Vested

     —          —        

Cancelled

     (6,032   $ 6.72      
  

 

 

      

Unvested at March 31, 2012

     517,314      $ 7.44       $ 2,478   
  

 

 

      

Income taxes

The Company accounts for income taxes in accordance with the FASB provisions on accounting for income taxes, which requires companies to account for deferred income taxes using the asset and liability method. Under the asset and liability method, current income tax expense or benefit is the amount of income taxes expected to be payable or refundable for the current year. A deferred income tax asset or liability is recognized for future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases and tax credits and loss carryforwards. Deferred tax assets are reduced by a valuation allowance when, in the opinion of management, it is more likely than not that some portion or all of the deferred tax assets will not be realized. Tax rate changes are reflected in income during the period such changes are enacted. Changes in ownership may limit the amount of net operating loss carryforwards that can be utilized in the future to offset taxable income.

 

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VANDA PHARMACEUTICALS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) – (continued)

 

Recent Accounting Pronouncements

In June 2011, the FASB issued an Accounting Standards Update which eliminates the option to report other comprehensive income and its components in the statement of changes in stockholders’ equity. It requires an entity to present total comprehensive income, which includes the components of net income and the components of other comprehensive income either in a single continuous statement or in two separate but consecutive statements. This pronouncement is effective for financial statements issued for annual and interim periods within the first annual period beginning after December 15, 2011 and must be applied retroactively. The pronouncement, adopted by the Company in the first quarter of 2012, did not have a material impact on the Company’s financial position or results of operations.

 

3. Earnings per Share

Net income (loss) per share is calculated in accordance with FASB guidance on earnings per share. Basic earnings per share (EPS) is calculated by dividing the net income (loss) by the weighted average number of shares of common stock outstanding. Diluted EPS is computed by dividing the net income (loss) by the weighted average number of shares of common stock outstanding, plus potential outstanding common stock for the period. Potential outstanding common stock includes stock options and shares underlying RSUs, but only to the extent that their inclusion is dilutive.

The following table presents the calculation of basic and diluted net income (loss) per share of common stock for the three months ended March 31, 2012 and 2011:

 

     Three Months Ended  
(in thousands, except for share and per share amounts)    March 31,
2012
    March 31,
2011
 

Numerator:

    

Net income (loss)

   $ (7,962   $ 136   
  

 

 

   

 

 

 

Denominator:

    

Weighted average shares of common stock outstanding, basic

     28,226,743        28,101,418   

Stock options and restricted stock units related to the issuance of common stock

     —          835,417   
  

 

 

   

 

 

 

Weighted average shares of common stock outstanding, diluted

     28,226,743        28,936,835   
  

 

 

   

 

 

 

Net income (loss) per share:

    

Basic

   $ (0.28   $ 0.00   
  

 

 

   

 

 

 

Diluted

   $ (0.28   $ 0.00   
  

 

 

   

 

 

 

Anti-dilutive securities not included in diluted net income (loss) per share calculation:

    

Options to purchase common stock and restricted stock units

     5,203,788        3,146,805   

 

4. Marketable Securities

The following is a summary of the Company’s available-for-sale marketable securities as of March 31, 2012:

 

(in thousands)    Amortized
Cost
     Gross
Unrealized
Gains
     Gross
Unrealized
Losses
    Fair Market
Value
 

Current:

          

U.S. Treasury and government agencies

   $ 28,311       $ 8       $ —        $ 28,319   

U.S. corporate debt

     20,819         23         (5     20,837   
  

 

 

    

 

 

    

 

 

   

 

 

 
   $ 49,130       $ 31       $ (5   $ 49,156   
  

 

 

    

 

 

    

 

 

   

 

 

 

 

14


Table of Contents

VANDA PHARMACEUTICALS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) – (continued)

 

The following is a summary of the Company’s available-for-sale marketable securities as of December 31, 2011:

 

(in thousands)    Amortized
Cost
     Gross
Unrealized
Gains
     Gross
Unrealized
Losses
    Fair Market
Value
 

Current:

          

U.S. Treasury and government agencies

   $ 23,747       $ 10       $ (2   $ 23,755   

U.S. corporate debt

     37,205         8         (7     37,206   
  

 

 

    

 

 

    

 

 

   

 

 

 
   $ 60,952       $ 18       $ (9   $ 60,961   
  

 

 

    

 

 

    

 

 

   

 

 

 

Non-current:

          
  

 

 

    

 

 

    

 

 

   

 

 

 

U.S. Treasury and government agencies

   $ 19,000       $ 12       $ —        $ 19,012   
  

 

 

    

 

 

    

 

 

   

 

 

 

 

5. Prepaid Expenses, Deposits and Other Current Assets

The following is a summary of the Company’s prepaid expenses, deposits and other current assets, as of March 31, 2012 and December 31, 2011:

 

(in thousands)    March 31,
2012
     December 31,
2011
 

Prepaid insurance

   $ 69       $ 165   

Other prepaid expenses and vendor advances

     2,128         2,474   

Accrued interest income

     334         244   

Other receivable

     33         116   
  

 

 

    

 

 

 

Total prepaid expenses, deposits and other current assets

   $ 2,564       $ 2,999   
  

 

 

    

 

 

 

 

6. Property and Equipment, Net

The following is a summary of the Company’s property and equipment-at cost, as of March 31, 2012 and December 31, 2011:

 

(in thousands)    Estimated  Useful
Life

(Years)
   March 31,
2012
    December 31,
2011
 

Laboratory equipment

   5    $ 1,273      $ 1,273   

Computer equipment

   3      1,185        1,105   

Furniture and fixtures

   7      853        700   

Leasehold improvements

   10-11      1,728        844   

Leasehold improvements-in-progress

   N/A      —          116   
     

 

 

   

 

 

 
        5,039        4,038   

Less—accumulated depreciation and amortization

        (2,561     (3,074
     

 

 

   

 

 

 
      $ 2,478      $ 964   
     

 

 

   

 

 

 

Depreciation and amortization expense for the three months ended March 31, 2012 and 2011 was $0.3 million and $0.1 million, respectively.

 

7. Intangible Asset, Net

The following is a summary of the Company’s intangible asset as of March 31, 2012:

 

          March 31, 2012  

(in thousands)

   Estimated
Useful Life
(Years)
   Gross
Carrying
Amount
     Accumulated
Amortization
     Net
Carrying
Amount
 

Fanapt®

   8    $ 12,000       $ 4,342       $ 7,658   
     

 

 

    

 

 

    

 

 

 

The following is a summary of the Company’s intangible asset as of December 31, 2011:

 

          December 31, 2011  

(in thousands)

   Estimated
Useful Life
(Years)
   Gross
Carrying
Amount
     Accumulated
Amortization
     Net
Carrying
Amount
 

Fanapt®

   8    $ 12,000       $ 3,973       $ 8,027   
     

 

 

    

 

 

    

 

 

 

 

15


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VANDA PHARMACEUTICALS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) – (continued)

 

On May 6, 2009, the Company announced that the FDA had approved the NDA for Fanapt®. As a result of the FDA’s approval of the NDA for Fanapt®, the Company met a milestone under its original sublicense agreement with Novartis which required the Company to make a payment of $12.0 million to Novartis. The $12.0 million is being amortized on a straight line basis over the remaining life of the U.S. patent for Fanapt®, which the Company expects to last until May 2017. This includes the Hatch-Waxman extension that provides patent protection for drug compounds for a period of five years to compensate for time spent in development and a six-month pediatric term extension. Fanapt® has qualified for the full five-year patent term Hatch-Waxman extension and the Company expects that Fanapt® will be eligible for six months of pediatric exclusivity. This term is the Company’s best estimate of the life of the patent; if, however, the pediatric extension is not granted, the intangible asset will be amortized over a shorter period.

Intangible assets are amortized over their estimated useful economic life using the straight line method. Amortization expense was $0.4 million for each of the three months ended March 31, 2012 and 2011. The Company capitalized and began amortizing the asset immediately following the FDA approval of the NDA for Fanapt®.

 

8. Accrued Liabilities

The following is a summary of the Company’s accrued liabilities as of March 31, 2012 and December 31, 2011:

 

(in thousands)      March 31,
2012
     December 31,
2011
 

Current:

       

Accrued research and development expenses

     $ 2,596       $ 1,967   

Accrued consulting and other professional fees

       283         317   

Employee benefits

       421         100   

Accrued lease termination penalty (refer to footnote 10)

       740         740   

Accrued lease exit liability, current (refer to footnote 10)

       1,007         —     

Other accrued liabilities

       46         257   
    

 

 

    

 

 

 

Total accrued liabilities, current

     $ 5,093       $ 3,381   
    

 

 

    

 

 

 

Non-current:

       

Accrued lease exit liability, non-current (refer to footnote 10)

     $ 278       $ —     
    

 

 

    

 

 

 

 

9. Revenue Recognition

The following is a summary of the Company’s revenues:

 

(in thousands)    December 31, 2011
Deferred Revenue
     Revenue
Recognized
     March 31, 2012
Deferred Revenue
 

Revenues:

        

Licensing agreement

   $ 143,853       $ 6,606       $ 137,247   

Royalty revenue

     —           1,535         —     
  

 

 

    

 

 

    

 

 

 

Total

   $ 143,853       $ 8,141       $ 137,247   
  

 

 

    

 

 

    

 

 

 

Vanda entered into an amended and restated sublicense agreement with Novartis on October 12, 2009, pursuant to which Novartis has the right to commercialize and develop Fanapt® in the U.S. and Canada. Under the amended and restated sublicense agreement, Vanda received an upfront payment of $200.0 million in December of 2009. Revenue related to the upfront payment will be recognized ratably from the date the amended and restated sublicense agreement became effective (November 27, 2009) through the expected life of the U.S. patent for Fanapt® (May 2017). This includes the Hatch-Waxman extension that provides patent protection for drug compounds for a period of five years to compensate for time spent in development and a six-month pediatric term extension. Fanapt® has qualified for the full five-year patent term Hatch-Waxman extension and the Company expects that Fanapt® will be eligible for six months of pediatric exclusivity. This term is the Company’s best estimate of the life of the patent. For the three months ended March 31, 2012, the Company recognized $6.6 million of revenue from the amended and restated sublicense agreement. Vanda recognized royalty revenue of $1.5 million for the three months ended March 31, 2012. Royalty revenue is based on a percentage of the quarterly net sales of Fanapt® sold in the U.S. and Canada by Novartis and is recorded when reliably measurable and earned.

 

16


Table of Contents

VANDA PHARMACEUTICALS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) – (continued)

 

10. Commitments and Contingencies

The following is a summary of the Company’s long-term contractual cash obligations as of March 31, 2012:

 

     Cash payments due by period  
(in thousands)    Total      April to
December 2012
     2013      2014      2015      2016      After
2016
 

Operating leases

   $ 11,550       $ —         $ 859       $ 1,052       $ 1,079       $ 1,106       $ 7,454   

Lease termination penalty

     740         740         —           —           —           —           —     

Lease exit liability

     1,285         728         557         —           —           —           —     

Consulting fees

     1,600         1,600         —           —           —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 15,175       $ 3,068       $ 1,416       $ 1,052       $ 1,079       $ 1,106       $ 7,454   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Operating leases

The Company’s commitments related to operating leases shown above consist of payments relating to a real estate lease for its current headquarters located in Washington, D.C. On July 25, 2011, the Company entered into a lease with Square 54 Office Owner LLC (the Landlord) for Vanda’s current headquarters, consisting of 21,400 square feet at 2200 Pennsylvania Avenue, N.W. in Washington, D.C. (the Lease). Under the Lease, which has an 11 year term commencing on April 1, 2012, the Company will pay $1.6 million in annual rent over the term of the Lease; however, rent will be abated for the first 12 months. The Landlord will provide the Company with an allowance of $1.9 million for leasehold improvements. As of March 31, 2012, the Company had received $1.7 million of the allowance. Subject to the prior rights of other tenants in the building, the Company will have the right to renew the Lease for five years following the expiration of its original term. The Company will also have the right to sublease or assign all or a portion of the premises, subject to standard conditions. The Lease may be terminated early by the Company or the Landlord upon certain conditions. The Company paid a security deposit of $0.5 million upon execution of the Lease.

As a result of the Company’s relocation from Rockville, Maryland to Washington, D.C., the Company provided notice to its previous landlord, that it was terminating its previous lease effective June 30, 2013. As a result of terminating this lease, the Company recognized expenses of $0.7 million in the fourth quarter of 2011 related to a lease termination penalty. Of this amount, $0.6 million was presented as research and development expense on the consolidated statement of operations for the year ended December 31, 2011 and $0.1 million was presented as general and administrative expense on the consolidated statement of operations for the year ended December 31, 2011. In the first quarter of 2012, the Company ceased using the Rockville, Maryland location and, as a result, recognized additional rent expense of $0.8 million. This $0.8 million consisted of a lease exit liability of $1.3 million for the remaining payments required under the lease and the reversal of the deferred rent balance of $0.5 million related to the Rockville, Maryland lease. The costs associated with the lease exit liability are included in the table above. Of the $0.8 million, $0.6 million is presented as research and development expense on the consolidated statement of operations for the quarter ended March 31, 2012 and $0.2 million is presented as general and administrative expense on the consolidated statement of operations for the quarter ended March 31, 2012.

The following is a summary of the Company’s lease exit activity:

 

(in thousands)    Balance At
Beginning Of Period
     Costs Incurred and
Charged to Expense
     Costs Paid or
Otherwise Settled
     Adjustments      Balance At End Of
Period
 

Period ended:

                 

December 31, 2011

   $           —         $ 740       $ —         $ —         $ 740   

March 31, 2012

   $           740       $ 1,285       $ —         $ —         $ 2,025   

Rent expense for the three months ended March 31, 2012 and 2011 was $1.4 million and $0.3 million, respectively.

 

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VANDA PHARMACEUTICALS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) – (continued)

 

Consulting fees

The Company has engaged a regulatory consultant to assist in the Company’s efforts to prepare, file and obtain FDA approval of a NDA for tasimelteon. The initial term of the engagement is for the 15-month period from October 2011 to December 2012. The Company is obligated to pay the consultant $1.6 million between April 2012 and December 2012. As part of this engagement, and subject to certain conditions, the Company will be obligated to make milestone payments in the aggregate amount of $2.8 million upon the achievement of certain milestones, including $2.0 million in the event that a tasimelteon NDA is approved by the FDA. In addition to these fees and milestone payments, the Company is obligated to reimburse the consultant for its ordinary and necessary business expenses incurred in connection with its engagement. The Company may terminate the engagement at any time upon prior notice; however, subject to certain conditions, the Company will remain obligated to make some or all of the milestone payments if the milestones are achieved following such termination.

Guarantees and indemnifications

The Company has entered into a number of standard intellectual property indemnification agreements in the ordinary course of its business. Pursuant to these agreements, the Company indemnifies, holds harmless, and agrees to reimburse the indemnified party for losses suffered or incurred by the indemnified party, generally the Company’s business partners or customers, in connection with any U.S. patent or any copyright or other intellectual property infringement claim by any third party with respect to the Company’s products. The term of these indemnification agreements is generally perpetual from the date of execution of the agreement. The maximum potential amount of future payments the Company could be required to make under these indemnification agreements is unlimited. The Company also indemnifies its officers and directors for certain events or occurrences, subject to certain conditions. Since inception, the Company has not incurred costs to defend lawsuits or settle claims related to these indemnification agreements. The Company believes that the fair value of the indemnification agreements is minimal, and accordingly the Company has not recognized any liabilities relating to these agreements as of March 31, 2012.

License agreements

The Company’s rights to develop and commercialize its products are subject to the terms and conditions of licenses granted to the Company by other pharmaceutical companies.

Fanapt® . The Company acquired exclusive worldwide rights to patents and patent applications for Fanapt® (iloperidone), in 2004 through a sublicense agreement with Novartis. A predecessor company of sanofi-aventis, Hoechst Marion Roussel, Inc. (HMRI), discovered Fanapt® and completed early clinical work on the compound. In 1996, following a review of its product portfolio, HMRI licensed its rights to the Fanapt® patents and patent applications to Titan Pharmaceuticals, Inc. (Titan) on an exclusive basis. In 1997, soon after it had acquired its rights, Titan sublicensed its rights to Fanapt® on an exclusive basis to Novartis. In June 2004, the Company acquired exclusive worldwide rights to these patents and patent applications as well as certain Novartis patents and patent applications to develop and commercialize Fanapt® through a sublicense agreement with Novartis. In partial consideration for this sublicense, the Company paid Novartis an initial license fee of $0.5 million and was obligated to make future milestone payments to Novartis of less than $100.0 million in the aggregate (the majority of which were tied to sales milestones), as well as royalty payments to Novartis at a rate which, as a percentage of net sales, was in the mid-twenties. In November 2007, the Company met a milestone under this sublicense agreement relating to the acceptance of its filing of the NDA for Fanapt® for the treatment of schizophrenia and made a milestone payment of $5.0 million to Novartis. As a result of the FDA’s approval of the NDA for Fanapt® in May 2009, the Company met an additional milestone under this sublicense agreement which required the Company to make a payment of $12.0 million to Novartis.

On October 12, 2009, Vanda entered into an amended and restated sublicense agreement with Novartis which amended and restated the June 2004 sublicense agreement. Pursuant to the amended and restated sublicense agreement, Novartis has exclusive commercialization rights to all formulations of Fanapt® in the U.S. and Canada. Novartis began selling Fanapt® in the U.S. during the first quarter of 2010. Novartis is responsible for the further clinical development activities in the U.S. and Canada, including the development of a long-acting injectable (or depot) formulation of Fanapt®. Pursuant to the amended and restated sublicense agreement, Vanda received an upfront payment of $200.0 million and Vanda is eligible for additional payments totaling up to $265.0 million upon the achievement of certain commercial and development milestones for Fanapt® in the U.S. and Canada. Vanda also receives royalties, which, as a percentage of net sales, are in the low double-digits, on net sales of Fanapt® in the U.S. and Canada. In addition, Vanda is no longer required to make any future milestone payments with respect to sales of Fanapt® or any future royalty payments with respect to sales of Fanapt® in the U.S. and Canada. Vanda retains exclusive rights to Fanapt® outside the U.S. and Canada and Vanda has exclusive rights to use any of Novartis’ data for Fanapt® for developing and commercializing Fanapt® outside the U.S. and Canada. At Novartis’ option, Vanda will enter into good faith discussions with Novartis relating to the co-commercialization of Fanapt® outside of the U.S. and Canada or, alternatively, Novartis will receive a

 

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VANDA PHARMACEUTICALS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) – (continued)

 

royalty on net sales of Fanapt® outside of the U.S. and Canada. Novartis has chosen not to co-commercialize Fanapt® with Vanda in Europe and certain other countries and will instead receive a royalty on net sales in those countries. These include, but are not limited to, the countries in the European Union as well as Switzerland, Norway, Liechtenstein and Iceland. On July 22, 2011, the EMA notified Vanda that it had accepted for evaluation the MAA for oral iloperidone tablets. Vanda has received the initial list of comments from the EMA and has been granted a three-month extension of the review cycle in order to better prepare its responses to these comments. Vanda has entered into agreements with the following partners for the commercialization of Fanapt® in the countries set forth below:

 

Country

  

Partner

Mexico    Probiomed S.A. de C.V.
Argentina    Biotoscana Farma S.A.
Israel    Megapharm Ltd.

Vanda may lose its rights to develop and commercialize Fanapt® outside the U.S. and Canada if it fails to comply with certain requirements in the amended and restated sublicense agreement regarding its financial condition, or if Vanda fails to comply with certain diligence obligations regarding its development or commercialization activities or if Vanda otherwise breaches the amended and restated sublicense agreement and fails to cure such breach. Vanda’s rights to develop and commercialize Fanapt® outside the U.S. and Canada may be impaired if it does not cure breaches by Novartis of similar obligations contained its sublicense agreement with Titan for Fanapt®. In addition, if Novartis breaches the amended and restated sublicense agreement with respect to its commercialization activities in the U.S. or Canada, Vanda may terminate Novartis’ commercialization rights in the applicable country and Vanda would no longer receive royalty payments from Novartis in connection with such country in the event of such termination.

Tasimelteon. In February 2004, the Company entered into a license agreement with Bristol-Myers Squibb (BMS) under which the Company received an exclusive worldwide license under certain patents and patent applications, and other licenses to intellectual property, to develop and commercialize tasimelteon. In partial consideration for the license, the Company paid BMS an initial license fee of $0.5 million. The Company is also obligated to make future milestone payments to BMS of less than $40.0 million in the aggregate (the majority of which are tied to sales milestones) as well as royalty payments based on the net sales of tasimelteon at a rate which, as a percentage of net sales, is in the low teens. The Company made a milestone payment to BMS of $1.0 million under this license agreement in 2006 relating to the initiation of its first Phase III clinical trial for tasimelteon. The Company is also obligated under this agreement to pay BMS a percentage of any sublicense fees, upfront payments and milestone and other payments (excluding royalties) that the Company receives from a third party in connection with any sublicensing arrangement, at a rate which is in the mid-twenties. The Company has agreed with BMS in the license agreement for tasimelteon to use commercially reasonable efforts to develop and commercialize tasimelteon and to meet certain milestones in initiating and completing certain clinical work. The license agreement with BMS was amended in April 2010 to, among other things, extend the deadline by which the Company must enter into a development and commercialization agreement with a third party for tasimelteon until the earliest of: (i) the date mutually agreed upon by the Company and BMS following the provision by the Company to BMS of a full written report of the Phase III clinical studies on which the Company intends to rely for filing for marketing authorization for tasimelteon in its first major market country (Phase III report); (ii) the date of the acceptance by a regulatory authority of the filing by the Company for marketing authorization for tasimelteon in a major market country following the provision by the Company to BMS of the Phase III report; or (iii) May 31, 2013.

If the Company has not entered into such a development and commercialization agreement with respect to certain major market countries by the foregoing deadline, then BMS will have the option to exclusively develop and commercialize tasimelteon on its own in those countries not covered by such an agreement on pre-determined financial terms, including milestone and royalty payments. In addition to the foregoing, pursuant to the April 2010 amendment, Vanda’s deadline for filing a NDA for tasimelteon was extended until June 1, 2013.

Either party may terminate the tasimelteon license agreement under certain circumstances, including a material breach of the agreement by the other. In the event that BMS has not exercised its option to reacquire the rights to tasimelteon and the Company terminates the license, or if BMS terminates the license due to the Company’s breach, all rights licensed and developed by the Company under this agreement will revert or otherwise be licensed back to BMS on an exclusive basis.

 

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VANDA PHARMACEUTICALS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) – (continued)

 

Future license payments. No amounts were recorded as liabilities nor were any contractual obligations relating to the license agreements included in the condensed consolidated financial statements as of March 31, 2012, since the amounts, timing and likelihood of these future payments are unknown and will depend on the successful outcome of future clinical trials, regulatory filings, favorable FDA regulatory approvals, growth in product sales and other factors.

Research and development and marketing agreements

In the course of its business the Company regularly enters into agreements with clinical organizations to provide services relating to clinical development and clinical manufacturing activities under fee service arrangements. The Company’s current agreements for clinical services may be terminated on no more than 60 days notice without incurring additional charges, other than charges for work completed but not paid for through the effective date of termination and other costs incurred by the Company’s contractors in closing out work in progress as of the effective date of termination.

 

11. Income Taxes

The Company did not record any tax provision or benefit for the three months ended March 31, 2012. The Company has provided a valuation allowance for the full amount of its net deferred tax asset since realization of any future benefit from deductible temporary differences and net operating losses could not be sufficiently assured as of March 31, 2012.

 

12. Fair Value Measurements

FASB guidance establishes a three-tier fair value hierarchy, which prioritizes the inputs used in measuring fair value. These tiers include:

 

   

Level 1 — defined as observable inputs such as quoted prices in active markets

 

   

Level 2 — defined as inputs other than quoted prices in active markets that are either directly or indirectly observable

 

   

Level 3 — defined as unobservable inputs in which little or no market data exists, therefore requiring an entity to develop its own assumptions

Marketable securities classified in Level 1 and Level 2 at March 31, 2012 and December 31, 2011 include available-for-sale marketable securities. The valuation of Level 1 instruments is determined using a market approach, and is based upon unadjusted quoted prices for identical assets in active markets. The valuation of investments classified in Level 2 also is determined using a market approach based upon quoted prices for similar assets in active markets, or other inputs that are observable for substantially the full term of the financial instrument. Level 2 securities include commercial paper, corporate notes and government agency notes that use as their basis readily observable market parameters.

As of March 31, 2012, the Company held certain assets that are required to be measured at fair value on a recurring basis.

 

     Fair Value Measurements at Reporting Date Using  
(in thousands)    March 31, 2012      Quoted Prices in
Active  Markets for
Identical Assets
(Level 1)
     Significant Other
Observable  Inputs
(Level 2)
     Significant
Unobservable  Inputs
(Level 3)
 

Description:

           

Available-for-sale securities

   $ 49,156       $ 28,319       $ 20,837       $ —     
  

 

 

    

 

 

    

 

 

    

 

 

 

 

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VANDA PHARMACEUTICALS INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (unaudited) – (continued)

 

As of December 31, 2011, the Company held certain assets that are required to be measured at fair value on a recurring basis.

 

     Fair Value Measurements at Reporting Date Using  
(in thousands)    December 31,
2011
     Quoted Prices in
Active  Markets for
Identical Assets
(Level 1)
     Significant Other
Observable  Inputs
(Level 2)
     Significant
Unobservable  Inputs
(Level 3)
 

Description:

           

Available-for-sale securities

   $ 79,973       $ 42,767       $ 37,206       $ —     
  

 

 

    

 

 

    

 

 

    

 

 

 

The Company also has financial assets and liabilities, not required to be measured at fair value on a recurring basis, which primarily consist of cash and cash equivalents, accounts receivable, restricted cash and accounts payable, the carrying value of which materially approximate their fair values.

 

13. Subsequent Event

On April 12, 2012, Vanda entered into a license agreement with Eli Lilly and Company (Lilly) pursuant to which Vanda acquired an exclusive worldwide license under certain patents and patent applications, and other licenses to intellectual property, to develop and commercialize a neurokinin-1 receptor (NK-1R) antagonist, VLY-686, for all human indications. The patent describing VLY-686 as a new chemical entity expires in April 2023, except in the U.S., where it expires in June 2024 absent any applicable patent term adjustments.

Pursuant to the agreement, Vanda will pay an initial license fee of $1.0 million and will be responsible for all development costs. The initial license fee will be recognized as an expense in the second quarter of 2012 and presented as research and development expense on the consolidated statement of operations for the quarter ended June 30, 2012. Lilly is also eligible to receive additional payments based upon achievement of specified development and commercialization milestones as well as tiered-royalties on net sales at percentage rates up to the low double digits. These milestones include $4.0 million for pre-NDA approval milestones and up to $95.0 million for future regulatory approval and sales milestones. Vanda has agreed to use its commercially reasonable efforts to develop and commercialize VLY-686.

Either party may terminate the agreement under certain circumstances, including a material breach of the agreement by the other. In the event that Vanda terminates the agreement, or if Lilly terminates due to Vanda’s breach, all rights licensed and developed by Vanda under the agreement will revert or otherwise be licensed back to Lilly on an exclusive basis.

 

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

Various statements in this report are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may appear throughout this report. Words such as, but not limited to, “believe,” “expect,” “anticipate,” “estimate,” “project,” “goal,” “intend,” “plan,” “target,” “likely,” “will,” “would,” and “could,” or the negative of these terms and similar expressions or words, identify forward-looking statements. Forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. Important factors that could cause actual results to differ materially from those reflected in our forward-looking statements include, among others:

 

   

the extent and effectiveness of the development, sales and marketing and distribution support Fanapt® receives;

 

   

our ability to successfully commercialize Fanapt® outside of the U.S. and Canada;

 

   

delays in the completion of our or our partners’ clinical trials;

 

   

a failure of our products, product candidates or partnered products to be demonstrably safe and effective;

 

   

our failure to obtain regulatory approval for our products or product candidates or to comply with ongoing regulatory requirements;

 

   

a lack of acceptance of our products, product candidates or partnered products in the marketplace, or a failure to become or remain profitable;

 

   

our expectations regarding trends with respect to our costs and expenses;

 

   

our inability to obtain the capital necessary to fund our research and development activities;

 

   

our failure to identify or obtain rights to new products or product candidates;

 

   

our failure to develop or obtain sales, marketing and distribution resources and expertise or to otherwise manage our growth;

 

   

limitations on our ability to utilize some or all of our prior net operating losses and research and development credits;

 

   

a loss of any of our key scientists or management personnel;

 

   

losses incurred from product liability claims made against us; and

 

   

a loss of rights to develop and commercialize our products or product candidates under our license and sublicense agreements.

All written and verbal forward-looking statements attributable to us or any person acting on our behalf are expressly qualified in their entirety by the cautionary statements contained or referred to in this section. We caution investors not to rely too heavily on the forward-looking statements we make or that are made on our behalf. We undertake no obligation, and specifically decline any obligation, to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

We encourage you to read the discussion and analysis of our financial condition and our condensed consolidated financial statements contained in this quarterly report on Form 10-Q. We also encourage you to read Item 1A of Part II of this quarterly report on Form 10-Q entitled “Risk Factors” and Item 1A of Part I of our Annual Report on Form 10-K for the fiscal year ended December 31, 2011 which contain a more complete discussion of the risks and uncertainties associated with our business. In addition to the risks described above and in Item 1A of Part II of this report and Item 1A of Part I of our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, other unknown or unpredictable factors also could affect our results. Therefore, the information in this report should be read together with other reports and documents that we file with the Securities and Exchange Commission (SEC) from time to time, including Forms 10-Q, 8-K and 10-K, which may supplement, modify, supersede or update those risk factors. There can be no assurance that the actual results or developments anticipated by us will be realized or, even if substantially realized, that they will have the expected consequences to, or effects on, us. Therefore, no assurance can be given that the outcomes stated in such forward-looking statements and estimates will be achieved.

 

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Overview

We are a biopharmaceutical company focused on the development and commercialization of products for the treatment of central nervous system disorders. We believe that each of our products and partnered products will address a large market with significant unmet medical needs by offering advantages over currently available therapies. Our product portfolio includes Fanapt® (iloperidone), a compound for the treatment of schizophrenia, the oral formulation of which is currently being marketed and sold in the U.S. by Novartis, and tasimelteon, a compound for the treatment of sleep and mood disorders, including circadian rhythm sleep disorders (CRSD), which is currently in clinical development.

Pursuant to our amended and restated sublicense agreement with Novartis, we received an upfront payment of $200.0 million and are eligible for additional payments totaling up to $265.0 million upon the achievement of certain commercial and development milestones for Fanapt® in the U.S. and Canada. We also receive royalties, which, as a percentage of net sales, are in the low double-digits, on net sales of Fanapt® in the U.S. and Canada. We retain exclusive rights to Fanapt® outside the U.S. and Canada and we have exclusive rights to use any of Novartis’ data for Fanapt® for developing and commercializing Fanapt® outside the U.S. and Canada. For the three months ended March 31, 2012, we incurred $0.4 million in research and development costs directly attributable to our development of Fanapt®.

We are conducting four clinical trials to pursue U.S. Food and Drug Administration (FDA) approval of tasimelteon for the treatment of Non-24-Hour Disorder (N24HD) in blind individuals without light perception. Two of the clinical trials were initiated in the third quarter of 2010, the third was initiated in the third quarter of 2011 and the fourth was initiated in the fourth quarter of 2011. In addition, in the third quarter of 2011, we initiated a Phase IIb/III clinical trial to study the efficacy of tasimelteon for the treatment of Major Depressive Disorder (MDD). During the three months ended March 31, 2012, we incurred $10.5 million in research and development costs directly attributable to our development of tasimelteon.

Since we began our operations in March 2003, we have devoted substantially all of our resources to the in-licensing and clinical development of our compounds. Our ability to generate additional revenues largely depends on Novartis’ ability to successfully commercialize Fanapt® in the U.S. and to successfully develop and commercialize Fanapt® in Canada and upon our ability, alone or with others, to complete the development of our products or product candidates, and to obtain the regulatory approvals for and manufacture, market and sell our products and product candidates.

The results of our operations will vary significantly from year-to-year and quarter-to-quarter and depend on a number of factors, including risks related to our business, risks related to our industry, and other risks which are detailed in Item 1A of Part II of this quarterly report on Form 10-Q, entitled “Risk Factors” and in Item 1A of Part I of our Annual Report on Form 10-K for the year ended December 31, 2011.

Revenues. Our revenues are derived primarily from our amended and restated sublicense agreement with Novartis and include an upfront payment, product sales and future milestone and royalty payments. Revenue is considered both realizable and earned when each one of the following four conditions is met: (1) persuasive evidence of an arrangement exists, (2) the arrangement fee is fixed or determinable, (3) delivery or performance has occurred and (4) collectability is reasonably assured. Revenue related to the $200.0 million upfront payment will be recognized ratably on a straight-line basis from the date the amended and restated sublicense agreement became effective (November 27, 2009) through the expected life of the U.S. patent for Fanapt®, which we expect to last until May 2017. This includes the Hatch-Waxman extension that extends patent protection for drug compounds for a period of five years to compensate for time spent in development and a six-month pediatric term extension. Fanapt® has qualified for the full five-year patent term Hatch-Waxman extension and we expect that Fanapt® will be eligible for six months of pediatric exclusivity. We recognize revenue from Fanapt® royalties and commercial and development milestones from Novartis when realizable and product revenue upon delivery of our products to Novartis.

Research and development expenses.

Our research and development expenses consist primarily of fees paid to third-party professional service providers in connection with the services they provide for our clinical trials, costs of contract manufacturing services, costs of materials used in clinical trials and research and development, costs for regulatory consultants and filings, depreciation of capital resources used to develop our products, all related facilities costs, and salaries, benefits and stock-based compensation expenses related to our research and development personnel. We expense research and development costs as incurred for compounds in the development stage, including certain payments made under our license agreements prior to FDA approval. Prior to FDA approval , all Fanapt® manufacturing-related and milestone costs were included in research and development expenses. Subsequent to FDA approval of Fanapt®, manufacturing and milestone costs related to this product are being capitalized. Costs related to the acquisition of intellectual property have been expensed as incurred since the underlying technology associated with these acquisitions were made in connection with the Company’s research and development efforts and have no alternative future use. Milestone payments are accrued in accordance with the FASB guidance on accounting for contingencies which states that milestone payments be accrued when it is deemed probable that the milestone event will be achieved. We believe that significant investment in product development is a competitive necessity and plan to continue these investments in order to realize the potential of our products and product candidates and pharmacogenetics and pharmacogenomics expertise. For the three months ended March 31, 2012, we incurred research and development expenses in the aggregate of $12.2 million, including stock-based compensation expenses of

 

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$0.6 million. We expect our research and development expenses to increase as we continue to develop our products and product candidates. We expect to incur licensing costs in the future that could be substantial, as we continue our efforts to develop our products, product candidates and partnered products and to evaluate potential in-license product candidates or compounds.

The following table summarizes our product development initiatives for the three months ended March 31, 2012 and 2011. Included in this table are the research and development expenses recognized in connection with the clinical development of Fanapt® and tasimelteon.

 

     Three Months Ended  
(in thousands)    March 31,
2012
     March 31,
2011
 

Direct project costs(1)

     

Fanapt®

   $ 432       $ 349   

Tasimelteon

     10,502         3,685   
  

 

 

    

 

 

 

Total direct project costs

     10,934         4,034   
  

 

 

    

 

 

 

Indirect project costs(1)

     

Facility

     997         155   

Depreciation

     185         42   

Other indirect overhead

     64         36   
  

 

 

    

 

 

 

Total indirect project costs

     1,246         233   
  

 

 

    

 

 

 

Total research and development expenses

   $ 12,180       $ 4,267   
  

 

 

    

 

 

 

 

(1) Many of our research and development costs are not attributable to any individual project because we share resources across several development projects. We record direct costs, including personnel costs and related benefits and stock-based compensation, on a project-by-project basis. We record indirect costs that support a number of our research and development activities in the aggregate.

General and administrative expenses. General and administrative expenses consist primarily of salaries, other related costs for personnel, including stock-based compensation, related to executive, finance, accounting, information technology, marketing, and human resource functions. Other costs include facility costs not otherwise included in research and development expenses and fees for legal, accounting and other professional services. General and administrative expenses also include third party expenses incurred to support business development, marketing and other business activities related to Fanapt®. For the three months ended March 31, 2012, we incurred general and administrative expenses in the aggregate of $3.9 million, including stock-based compensation expenses of $0.8 million.

Other income. Other income consists of interest income earned on our cash and cash equivalents, marketable securities and restricted cash and non-recurring income (expense) transactions which are outside of our normal business operations.

Critical Accounting Policies

The preparation of our condensed consolidated 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 our financial statements, as well as the reported revenues and expenses during the reported periods. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

Our significant accounting policies are described in the notes to our audited consolidated financial statements for the year ended December 31, 2011 included in our annual report on Form 10-K. However, we believe that the following critical accounting policies are important to understanding and evaluating our reported financial results, and we have accordingly included them in this quarterly report on Form 10-Q.

 

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Accrued expenses. As part of the process of preparing financial statements we are required to estimate accrued expenses. The estimation of accrued expenses involves identifying services that have been performed on our behalf, and then estimating the level of service performed and the associated cost incurred for such services as of each balance sheet date in the financial statements. Accrued expenses include professional service fees, such as lawyers and accountants, contract service fees, such as those under contracts with clinical monitors, data management organizations and investigators in conjunction with clinical trials, fees to contract manufacturers in conjunction with the production of clinical materials, and fees for marketing and other commercialization activities. Pursuant to our assessment of the services that have been performed on clinical trials and other contracts, we recognize these expenses as the services are provided. Our assessments include, but are not limited to: (1) an evaluation by the project manager of the work that has been completed during the period, (2) measurement of progress prepared internally and/or provided by the third-party service provider, (3) analyses of data that justify the progress, and (4) our judgment. In the event that we do not identify certain costs that have begun to be incurred or we under- or over-estimate the level of services performed or the costs of such services, our reported expenses for such period would be too low or too high.

Revenue Recognition. Our revenues are derived primarily from our amended and restated sublicense agreement with Novartis and include an upfront payment, product revenue and future milestone and royalty revenues. Revenue related to the upfront payment will be recognized ratably from the date the amended and restated sublicense agreement became effective (November 27, 2009) through the expected life of the U.S. patent for Fanapt®, which we expect to last until May 2017. This includes the Hatch-Waxman extension that extends patent protection for drug compounds for a period of five years to compensate for time spent in development and a six-month pediatric term extension. Fanapt® has qualified for the full five-year patent term Hatch-Waxman extension and we expect that Fanapt® will be eligible for six months of pediatric exclusivity. We recognize revenue related to Fanapt® royalties and commercial and development milestones as they are realizable and earned, and product revenue upon delivery of our products to Novartis.

Stock-based compensation. We currently use the Black-Scholes-Merton option pricing model to determine the fair value of stock options. The determination of the fair value of stock options on the date of grant using an option pricing model is affected by our stock price as well as assumptions regarding a number of complex and subjective variables. These variables include the expected stock price volatility over the expected term of the awards, actual and projected employee stock option exercise behaviors, risk-free interest rate and expected dividends. Due to the limited historic information on our publicly traded common stock, expected volatility rates are based on the historical volatility of our publicly traded common stock blended with the historical volatility of the common stock of comparable entities and other factors. The expected term of options granted is based on the transition approach provided by FASB guidance as the options meet the “plain vanilla” criteria required by this method. The risk-free interest rates are based on the U.S. Treasury yield for a period consistent with the expected term of the option in effect at the time of the grant. We have not paid dividends to our stockholders since our inception (other than a dividend of preferred share purchase rights which was declared on September 25, 2008) and do not plan to pay dividends in the foreseeable future. The stock-based compensation expense for a period is also affected by expected forfeiture rate for the respective option grants. If our estimates of the fair value of these equity instruments or expected forfeitures are too high or too low, it would have the effect of overstating or understating expenses.

Total employee stock-based compensation expense related to all of our stock-based awards during the three months ended March 31, 2012 and 2011 was comprised of the following:

 

     Three Months Ended  
(in thousands)    March 31,
2012
     March 31,
2011
 

Research and development

   $ 593       $ 720   

General and administrative

     798         878   
  

 

 

    

 

 

 

Stock-based compensation expense

   $ 1,391       $ 1,598   
  

 

 

    

 

 

 

Income taxes. On a periodic basis, we evaluate the realizability of our deferred tax assets and liabilities and will adjust such amounts in light of changing facts and circumstances, including but not limited to future projections of taxable income, the reversal of deferred tax liabilities, tax legislation, rulings by relevant tax authorities and tax planning strategies. Settlement of filing positions that may be challenged by tax authorities could impact our income taxes in the year of resolution.

In assessing the realizability of deferred tax assets, we consider whether it is more likely than not that some portion or all of the deferred tax assets will not be realized. The ultimate realization of deferred tax assets is dependent upon the generation of future taxable income during the period in which those temporary differences becomes deductible or the NOLs and credit carryforwards can be utilized. When considering the reversal of the valuation allowance, we consider the level of past and future taxable income, the reversal of deferred tax liabilities, the utilization of the carryforwards and other factors. Revisions to the estimated net realizable value of the deferred tax asset could cause our provision for income taxes to vary significantly from period to period.

 

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Recent Accounting Pronouncements

In June 2011, the FASB issued an Accounting Standards Update which eliminates the option to report other comprehensive income and its components in the statement of changes in stockholders’ equity. It requires an entity to present total comprehensive income, which includes the components of net income and the components of other comprehensive income either in a single continuous statement or in two separate but consecutive statements. This pronouncement is effective for financial statements issued for annual and interim periods within the first annual period beginning after December 15, 2011 and must be applied retroactively. The pronouncement, which we adopted in the first quarter of 2012, did not have a material impact on our financial position or results of operations.

Results of Operations

We have a limited history of operations. We anticipate that our results of operations will fluctuate for the foreseeable future due to several factors, including any possible payments made or received pursuant to licensing or collaboration agreements, progress of our research and development efforts, the timing and outcome of clinical trials and related possible regulatory approvals and our and our partners’ ability to successfully commercialize our products, product candidates and partnered products. Our limited operating history makes predictions of future operations difficult or impossible. Since our inception, we have incurred significant losses. As of March 31, 2012, we had a deficit accumulated of $271.4 million.

Three months ended March 31, 2012 compared to three months ended March 31, 2011

Revenues. Revenues were $8.1 million for the three months ended March 31, 2012, compared to revenues of $7.5 million for the three months ended March 31, 2011. Revenues for the three months ended March 31, 2012 included $6.6 million recognized from Novartis related to straight-line recognition of up-front license fees and $1.5 million in royalty revenue based on first quarter 2012 sales of Fanapt®. Revenues for the three months ended March 31, 2011 included $6.6 million recognized from Novartis related to straight-line recognition of upfront license fees and $0.9 million in royalty revenue based on first quarter 2011 sales of Fanapt®.

Intangible asset amortization. Intangible asset amortization was $0.4 million for both the three months ended March 31, 2012 and the three months ended March 31, 2011. Intangible amortization relates to the capitalized intangible asset related to the $12.0 million milestone payment to Novartis in May 2009.

Research and development expenses. Research and development expenses increased by $7.9 million, or 185.4%, to $12.2 million for the three months ended March 31, 2012 compared to $4.3 million for the three months ended March 31, 2011.

The following table discloses the components of research and development expenses reflecting all of our project expenses for the three months ended March 31, 2012 and 2011:

 

     Three Months Ended  
(in thousands)    March 31,
2012
     March 31,
2011
 

Direct project costs:

     

Clinical trials

   $ 7,207       $ 1,525   

Contract research and development, consulting, materials and other direct costs

     1,933         895   

Salaries, benefits and related costs

     1,201         894   

Stock-based compensation

     593         720   
  

 

 

    

 

 

 

Total direct costs

     10,934         4,034   

Indirect project costs

     1,246         233   
  

 

 

    

 

 

 

Total

   $ 12,180       $ 4,267   
  

 

 

    

 

 

 

Direct costs increased $6.9 million primarily a result of increases in clinical trial costs, contract research and development, consulting, materials and other direct costs, salaries, benefits and related costs partially offset by lower stock based compensation. Clinical trials costs increased by $5.7 million primarily due to costs related to the tasimelteon trials for the treatment of N24HD in blind individuals without light perception and the tasimelteon trial for the treatment of MDD. Contract research and development consulting, materials and other direct costs increased by $1.0 million primarily due to costs related to the tasimleteon trials for the treatment of N24HD in blind individuals without light perception and the tasimeleton trial for the treatment of MDD. Salaries, benefits and related costs increased by $0.3 million primarily due to new employees hired in 2011 to support the tasimeleton trials in N24HD and MDD. Indirect costs increased by $1.0 million primarily as a result of the lease exit liability and accelerated depreciation recognized in the first quarter of 2012.

 

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General and administrative expenses. General and administrative expenses increased by $1.1 million, or 36.8%, to $3.9 million for the three months ended March 31, 2012 from $2.9 million for the three months ended March 31, 2011.

The following table discloses the components of our general and administrative expenses for the three months ended March 31, 2012 and 2011:

 

     Three Months Ended  
(in thousands)    March 31,
2012
     March 31,
2011
 

Salaries, benefits and related costs

   $ 729       $ 529   

Stock-based compensation

     798         878   

Marketing, legal, accounting and other professional expenses

     1,298         888   

Other expenses

     1,084         563   
  

 

 

    

 

 

 

Total

   $ 3,909       $ 2,858   
  

 

 

    

 

 

 

Salaries, benefits and related costs increased by $0.2 million as a result of an executive hiring made in the fourth quarter of 2011. Marketing, legal, accounting and other professional expenses increased by $0.4 million primarily due to increased legal and marketing expenses associated with our compounds. Other expenses increased by $0.5 million primarily as a result of the lease exit liability and accelerated depreciation recognized in the first quarter of 2012.

Other income. Other income increased by $0.2 million primarily as a result of a legal settlement related to a lawsuit filed against one of our shareholders. While we did not participate in the lawsuit proceedings, we received a portion of the settlement.

Liquidity and Capital Resources

As of March 31, 2012, our total cash and cash equivalents and marketable securities were $157.3 million compared to $167.9 million at December 31, 2011. Our cash and cash equivalents are deposits in operating accounts and highly liquid investments with an original maturity of 90 days or less at date of purchase and consist of time deposits, investments in money market funds with commercial banks and financial institutions, and commercial paper of high-quality corporate issuers. Our marketable securities consist of investments in government sponsored enterprises and commercial paper. As of March 31, 2012, we also held a non-current deposit of $0.4 million that is used to collateralize a letter of credit issued for our office lease in Rockville, Maryland which expires in 2013, a non-current deposit of $0.1 million related to a letter of credit issued for the Maryland Board of Pharmacy, and a non-current deposit of $0.5 million that is used to collateralize a letter of credit issued for our office lease in Washington, D.C. which expires in 2023.

As of March 31, 2012, we maintained all of our cash and cash equivalents in two financial institutions. Deposits held with these institutions may exceed the amount of insurance provided on such deposits, but we do not anticipate any losses with respect to such deposits.

We entered into an amended and restated sublicense agreement in 2009 with Novartis to commercialize Fanapt® in the U.S. and Canada. Novartis is responsible for the further clinical development activities in the U.S. and Canada, including the development of a long-acting injectable (or depot) formulation of Fanapt®. Pursuant to the amended and restated sublicense agreement, we received an upfront payment of $200.0 million, and are eligible for additional payments totaling up to $265.0 million upon the achievement of certain commercial and development milestones for Fanapt® in the U.S. and Canada. We will recognize the $200.0 million upfront payment ratably from the date the amended and restated sublicense agreement became effective (November 27, 2009) through the expected life of the U.S. patent for Fanapt® , which we expect to last until May 2017. This includes the Hatch-Waxman extension that provides patent protection for drug compounds for a period of five years to compensate for time spent in development and a six-month pediatric term extension. Fanapt® has qualified for the full five-year patent term Hatch-Waxman extension and we expect that Fanapt® will be eligible for six months of pediatric exclusivity. We also receive royalties, which, as a percentage of net sales, are in the low double digits, on net sales of Fanapt® in the U.S. and Canada. During the three months ended March 31, 2012, we recorded $6.6 million in licensing revenue and $1.5 million in royalty revenue. We recognize royalty revenue when realizable and earned. Other than participation in the Joint Steering Committee (JSC) established following the effective date of the amended and restated sublicense agreement with Novartis, we have no control over the progress of Novartis’ commercial plans. We cannot forecast with any degree of certainty the achievement of milestones and royalties under this agreement.

 

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We expect to continue to incur substantial expenses relating to our research and development efforts, as we focus on clinical trials and manufacturing required for the development of our active product candidates. We initiated four clinical trials to pursue FDA approval of tasimelteon for the treatment of N24HD in blind individuals without light perception. Two of the clinical trials were initiated in the third quarter of 2010, the third was initiated in the third quarter of 2011 and the fourth was initiated in the fourth quarter of 2011. The first clinical trial (SET-3201) is a randomized, double-blind, placebo-controlled study with a planned enrollment of approximately 100 patients with N24HD. The trial has a six month treatment period and includes measures of both nighttime and daytime sleep, as well as laboratory measures of the synchronization between the internal body clock and the 24-hour environmental light/dark cycle. The second clinical trial (3202) is a one-year safety study of tasimelteon for the treatment of N24HD. This trial is an open-label safety study with a planned enrollment of up to 140 patients with N24HD. The third clinical trial (RESET-3203) is a placebo-controlled, randomized withdrawal study to examine the maintenance effect of tasimelteon for the treatment of N24HD with a planned enrollment of up to 20 patients with N24HD. Patients will be followed for 12 weeks during which nighttime and daytime sleep, as well as synchronization of their internal body clock to the 24-hour day, will continue to be evaluated. The fourth clinical trial (3204) is a two-year open-label, multicenter, study in blind subjects with N24HD to assess the safety of tasimelteon. The tasimelteon N24HD program continues to advance towards its goal of a projected mid-2013 NDA filing with the FDA. Vanda is in continuing discussions with the FDA to confirm the path and requirements for this regulatory submission. Vanda expects to complete the two Phase III efficacy studies, SET and RESET, by the end of 2012. In addition, in the third quarter of 2011, we initiated a Phase IIb/III clinical trial (MAGELLAN-2301) to study the efficacy of tasimelteon for the treatment of MDD. The clinical trial is a randomized, double-blind, placebo-controlled study with a planned enrollment of approximately 500 patients with MDD. The trial has an eight-week treatment period, followed by an optional one-year open-label extension, and includes measures of depression and anxiety symptoms, nighttime and daytime sleep, as well as laboratory measures of the internal body clock. Given the range of potential indications for tasimelteon, we may pursue one or more partnerships for the development and commercialization of tasimelteon worldwide. The duration and cost of clinical trials are a function of numerous factors such as the number of patients to be enrolled in the trial, the amount of time it takes to enroll them, the length of time they must be treated and observed, and the number of clinical sites and countries for the trial. In addition, orphan clinical trials create an additional challenge due to the limited number of available patients afflicted with the disease.

We must receive regulatory approval to launch any of our products commercially. In order to receive such approval, the appropriate regulatory agency must conclude that our clinical data establish safety and efficacy and that our products and the manufacturing facilities meet all applicable regulatory requirements. We cannot be certain that we will establish sufficient safety and efficacy data to receive regulatory approval for any of our drugs or that our drugs and the manufacturing facilities will meet all applicable regulatory requirements.

Because of the uncertainties discussed above, the costs to advance our research and development projects are difficult to estimate and may vary significantly. We expect that our existing funds will be sufficient to fund our planned operations. Our future capital requirements and the adequacy of our available funds will depend on many factors, primarily including the scope and costs of our clinical development programs, the scope and costs of our manufacturing and process development activities, the magnitude of our discovery and preclinical development programs and the level of our pre-commercial launch activities. There can be no assurance that any additional financing required in the future will be available on acceptable terms, if at all.

Cash Flow

The following table summarizes our cash flows for the three months ended March 31, 2012 and 2011:

 

     Three Months Ended  
(in thousands)    March 31,
2012
    March 31,
2011
 

Net cash provided by (used in)

    

Operating activities

   $ (8,690   $ (3,264

Investing activities

     28,861        13,225   
  

 

 

   

 

 

 

Net change in cash and cash equivalents

   $ 20,171      $ 9,961   
  

 

 

   

 

 

 

 

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Net cash used in operations was $8.7 million and $3.3 million for the three months ended March 31, 2012 and 2011. The increase in net cash used in operations for the three months ended March 31, 2012 as compared to March 31, 2011 was primarily due to the costs associated with four Phase III clinical trials for tasimelteon in N24HD in blind individuals without light perception, which were initiated in 2010 and 2011, and one Phase IIb/III clinical trial for tasimelteon in MDD, which was initiated in the third quarter of 2011. Adjustments to reconcile net loss to net cash used in operating activities for the three months ended March 31, 2012, included non-cash charges for depreciation and amortization of $0.8 million and stock-based compensation of $1.4 million, increases in accrued liabilities, current and accrued liabilities, non-current of $2.0 million, decreases in prepaid expenses and other assets, accounts receivable, accounts payable and other liabilities of $0.1 million, landlord contributions for tenant improvements of $1.7 million and a decrease in deferred revenue of $6.6 million. Net cash provided by investing activities for the three months ended March 31, 2012 was $28.9 million and consisted of net maturities of marketable securities of $30.7 million and purchases of property and equipment of $1.8 million.

Effects of Inflation

Inflation does not have a material impact on our results of operations.

Off-balance sheet arrangements

We have no off-balance sheet arrangements, as defined in Item 303(a)(4) of the Securities and Exchange Commission’s Regulation S-K.

Contractual Obligations and Commitments

The following is a summary of our long-term contractual cash obligations as of March 31, 2012:

 

     Cash payments due by period  
(in thousands)    Total      April to
December 2012
     2013      2014      2015      2016      After
2016
 

Operating leases

   $ 11,550       $ —         $ 859       $ 1,052       $ 1,079       $ 1,106       $ 7,454   

Lease termination penalty

     740         740         —           —           —           —           —     

Lease exit liability

     1,285         728         557         —           —           —           —     

Consulting fees

     1,600         1,600         —           —           —           —           —     
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Total

   $ 15,175       $ 3,068       $ 1,416       $ 1,052       $ 1,079       $ 1,106       $ 7,454   
  

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

    

 

 

 

Operating leases

Our commitments related to operating leases shown above consist of payments relating to a real estate lease for our current headquarters located in Washington, D.C. On July 25, 2011, we entered into a lease with Square 54 Office Owner LLC (the Landlord) for our current headquarters, consisting of 21,400 square feet at 2200 Pennsylvania Avenue, N.W. in Washington, D.C. (the Lease). Under the Lease, which has an 11 year term commencing on April 1, 2012, we will pay $1.6 million in annual rent over the term of the Lease; however, rent will be abated for the first 12 months. The Landlord will provide us with an allowance of $1.9 million for leasehold improvements. As of March 31, 2012, we had received $1.7 million of the allowance. Subject to the prior rights of other tenants in the building, we will have the right to renew the Lease for five years following the expiration of its original term. We will also have the right to sublease or assign all or a portion of the premises, subject to standard conditions. The Lease may be terminated early by us or the Landlord upon certain conditions. We paid a security deposit of $0.5 million upon execution of the Lease.

As a result of our relocation from Rockville, Maryland to Washington, D.C., we provided notice to our previous landlord, that we were terminating our previous lease effective June 30, 2013. As a result of terminating this lease, we recognized expenses of $0.7 million in the fourth quarter of 2011 related to a lease termination penalty. Of this amount, $0.6 million was presented as research and development expense on the consolidated statement of operations for the year ended December 31, 2011 and $0.1 million is presented as general and administrative expense on the consolidated statement of operations for the year ended December 31, 2011. In the first quarter of 2012, we ceased using the Rockville, Maryland location and, as a result, recognized additional rent expense of $0.8 million. This $0.8 million consisted of a lease exit liability of $1.3 million for the remaining payments required under the lease and the reversal of the deferred rent balance of $0.5 million related to the Rockville, Maryland lease. The costs associated with the lease exit liability are included in the table above. Of the $0.8 million, $0.6 million is presented as research and development expense on the consolidated statement of operations for the quarter ended March 31, 2012 and $0.2 million is presented as general and administrative expense on the consolidated statement of operations for the quarter ended March 31, 2012.

 

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The following is a summary of our lease exit activity:

 

(in thousands)    Balance At
Beginning Of Period
     Costs Incurred and
Charged to Expense
     Costs Paid or
Otherwise Settled
     Adjustments      Balance At End Of
Period
 

Period ended:

              

December 31, 2011

   $ —         $ 740       $ —         $ —         $ 740   

March 31, 2012

   $ 740       $ 1,285       $ —         $ —         $ 2,025   

Rent expense for the three months ended March 31, 2012 and 2011 was $1.4 million and $0.3 million, respectively.

Consulting fees

We have engaged a regulatory consultant to assist in our efforts to prepare, file and obtain FDA approval of a NDA for tasimelteon. The initial term of the engagement is for the 15-month period from October 2011 to December 2012. We are obligated to pay the consultant $1.6 million between April 2012 and December 2012. As part of this engagement, and subject to certain conditions, we will be obligated to make milestone payments in the aggregate amount of $2.8 million upon the achievement of certain milestones, including $2.0 million in the event that a tasimelteon NDA is approved by the FDA. In addition to these fees and milestone payments, we are obligated to reimburse the consultant for its ordinary and necessary business expenses incurred in connection with its engagement. We may terminate the engagement at any time upon prior notice; however, subject to certain conditions, we will remain obligated to make some or all of the milestone payments if the milestones are achieved following such termination.

Clinical research organization contracts and other contracts

Other contracts. We have entered into agreements for tasimelteon with clinical supply manufacturing organizations and other outside contractors who will be responsible for additional services supporting our ongoing clinical development processes. These contractual obligations are not reflected in the table above because we may terminate them on no more than 60 days notice without incurring additional charges (other than charges for work completed but not paid for through the effective date of termination and other costs incurred by our contractors in closing out work in progress as of the effective date of termination).

License agreements. In February 2004 and June 2004, we entered into separate licensing agreements with BMS and Novartis, respectively, for the exclusive rights to develop and commercialize tasimelteon and Fanapt®. On April 15, 2010, we entered into an amended licensing agreement with BMS. On October 12, 2009, we entered into an amended and restated sublicense agreement with Novartis. We are obligated to make (in the case of tasimelteon and, in the case of Fanapt® in the U.S. and Canada, are entitled to receive) payments under the conditions in the agreements upon the achievement of specified clinical, regulatory and commercial milestones. If the products are successfully commercialized we will be required to pay certain royalties (and in the case of Fanapt® in the U.S. and Canada, will be entitled to receive) based on net sales for each of the licensed products.

As a result of the successful commencement of the Phase III clinical study of tasimelteon in March 2006, we met the first milestone specified in our licensing agreement with BMS and subsequently paid a license fee of $1.0 million. We are also obligated to make future milestone payments of less than $40.0 million in the aggregate (the majority of which are tied to sales milestones) as well as royalty payments based on the net sales of tasimelteon at a rate which, as a percentage of net sales, is in the low teens. We are also obligated under this license agreement to pay BMS a percentage of any sublicense fees, upfront payments and milestone and other payments (excluding royalties) that the Company receives from a third party in connection with any sublicensing arrangement, at a rate which is in the mid-twenties.

As a result of the acceptance by the FDA of the NDA for Fanapt® in October 2007, we met a milestone under our original sublicense agreement with Novartis and subsequently paid a $5.0 million milestone fee. As a result of the FDA’s approval of the NDA for Fanapt® in May 2009, we met an additional milestone under the original sublicense agreement with Novartis which required us to make a payment of $12.0 million to Novartis. The $12.0 million was capitalized and will be amortized over the remaining life of the U.S. patent for Fanapt®, which we expect to last until May 2017. This includes the Hatch-Waxman extension that provides patent protection for drug compounds for a period of five years to compensate for time spent in development and a six-month pediatric term extension. Fanapt® has qualified for the full five-year patent term Hatch-Waxman extension and we expect that Fanapt® will be eligible for six months of pediatric exclusivity. This term is our best estimate of the life of the patent; if, however, the pediatric extension is not granted, the intangible asset will be amortized over a shorter period. No amounts were recorded as liabilities relating to the license agreements included in the consolidated financial statements as of March 31, 2012, since the amounts, timing and likelihood of these payments are unknown and will depend on the successful outcome of future clinical trials, regulatory filings, favorable regulatory approvals, growth in product sales and other factors.

 

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Pursuant to the amended and restated sublicense agreement, Novartis has exclusive commercialization rights to all formulations of Fanapt® in the U.S. and Canada. Novartis is responsible for the further clinical development activities in the U.S. and Canada, including the development of a long-acting injectable (or depot) formulation of Fanapt®. Pursuant to the amended and restated sublicense agreement, we received an upfront payment of $200.0 million and are eligible for additional payments totaling up to $265.0 million upon the achievement of certain commercial and development milestones for Fanapt® in the U.S. and Canada. We also receive royalties, which, as a percentage of net sales, are in the low double-digits, on net sales of Fanapt® in the U.S. and Canada. In addition, we are no longer required to make any future milestone payments with respect to sales of Fanapt® or any royalty payments with respect to sales of Fanapt® in the U.S. and Canada. We retain exclusive rights to Fanapt® outside the U.S. and Canada and have exclusive rights to use any of Novartis’ data for Fanapt® for developing and commercializing Fanapt® outside the U.S. and Canada. At Novartis’ option, we will enter into good faith discussions with Novartis relating to the co-commercialization of Fanapt® outside of the U.S. and Canada or, alternatively, Novartis will receive a royalty on net sales of Fanapt® outside of the U.S. and Canada. Novartis has chosen not to co-commercialize Fanapt® with us in Europe and certain other countries and will instead receive a royalty on net sales in those countries. These include, but are not limited to, the countries in the European Union as well as Switzerland, Norway, Liechtenstein and Iceland. We have entered into agreements with the following partners for the commercialization of Fanapt® in the countries set forth below:

 

Country

  

Partner

Mexico    Probiomed S.A. de C.V.
Argentina    Biotoscana Farma S.A.
Israel    Megapharm Ltd.

Item 3. Quantitative and Qualitative Disclosures about Market Risk.

Interest Rates

Our exposure to market risk is currently confined to our cash and cash equivalents, marketable securities and restricted cash. We currently do not hedge interest rate exposure. We have not used derivative financial instruments for speculation or trading purposes. Because of the short-term maturities of our cash and cash equivalents and marketable securities, we do not believe that an increase in market rates would have any significant impact on the realized value of our investments.

Marketable Securities

We deposit our cash with financial institutions that we consider to be of high credit quality and purchase marketable securities which are generally investment grade, liquid, short-term fixed income securities and money-market instruments denominated in U.S. dollars.

Item 4. Controls and Procedures.

Conclusion Regarding the Effectiveness of Disclosure Controls and Procedures

Under the supervision and with the participation of our management, including our Chief Executive Officer and Chief Financial Officer, we evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act) as of March 31, 2012. Based upon that evaluation, our Chief Executive Officer and Chief Financial Officer concluded that our disclosure controls and procedures are effective as of March 31, 2012, the end of the period covered by this quarterly report, to ensure that the information required to be disclosed by us in the reports that we file or submit under the Exchange Act is recorded, processed, summarized and reported within the time periods specified in the SEC’s rules and forms, and that such information is accumulated and communicated to our management, including our Chief Executive Officer and Chief Financial Officer, as appropriate to allow timely decisions regarding required disclosures.

Changes in Internal Control over Financial Reporting

There has been no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act) during the first quarter of 2012 that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.

 

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PART II — OTHER INFORMATION

 

Item 1. Legal Proceedings.

None.

 

Item 1A. Risk Factors.

In our Annual Report on Form 10-K for the fiscal year ended December 31, 2011, filed with the SEC on March 9, 2012, we identify under Item 1A important factors which could affect our business, financial condition, results of operations and future operations and could cause our actual results for future periods to differ materially from our anticipated results or other expectations, including those expressed in any forward-looking statements made in this Form 10-Q. There have been no material changes in our risk factors subsequent to the filing of our Form 10-K for the fiscal year ended December 31, 2011.

 

Item 2. Unregistered Sales of Equity Securities and Use of Proceeds.

None.

 

Item 3. Defaults Upon Senior Securities.

None.

 

Item 4. Mine Safety Disclosures.

None.

 

Item 5. Other Information.

None.

Item 6. Exhibits.

 

Exhibit

Number

  

Description

  31.1    Certification of the Chief Executive Officer, as required by Section 302 of the Sarbanes-Oxley Act of 2002.
  31.2    Certification of the Chief Financial Officer, as required by Section 302 of the Sarbanes-Oxley Act of 2002.
  32.1    Certification of the Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer), as required by Section 906 of the Sarbanes-Oxley Act of 2002.
101    The following financial information from this Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2012, formatted in XBRL (eXtensible Business Reporting Language) and furnished electronically herewith: (i) Condensed Consolidated Balance Sheets as of March 31, 2012 and December 31, 2011; (ii) Condensed Consolidated Statements of Operations for the three months ended March 31, 2012 and 2011; (iii) Condensed Consolidated Statement of Comprehensive Income for the three months ended March 31, 2012 and 2011; (iv) Condensed Consolidated Statement of Changes in Stockholders’ Equity for the three months ended March 31, 2012; (v) Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2012 and 2011; and (vi) Notes to Condensed Consolidated Financial Statements.

The certification attached as Exhibit 32.1 that accompanies this Quarterly Report on Form 10-Q is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Vanda Pharmaceuticals Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.

 

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Table of Contents

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.

 

    Vanda Pharmaceuticals Inc.
May 9, 2012    

/s/     Mihael H. Polymeropoulos, M.D.

   

Mihael H. Polymeropoulos, M.D.

President and Chief Executive Officer

(Principal Executive Officer)

May 9, 2012    

/s/     James P. Kelly

   

James P. Kelly

Senior Vice President and Chief Financial Officer

(Principal Financial Officer and Principal Accounting Officer)

 

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Table of Contents

VANDA PHARMACEUTICALS INC.

EXHIBIT INDEX

 

Exhibit

Number

  

Description

  31.1    Certification of the Chief Executive Officer, as required by Section 302 of the Sarbanes-Oxley Act of 2002.
  31.2    Certification of the Chief Financial Officer, as required by Section 302 of the Sarbanes-Oxley Act of 2002.
  32.1    Certification of the Chief Executive Officer (Principal Executive Officer) and Chief Financial Officer (Principal Financial Officer and Principal Accounting Officer), as required by Section 906 of the Sarbanes-Oxley Act of 2002.
101    The following financial information from this Quarterly Report on Form 10-Q for the fiscal quarter ended March 31, 2012, formatted in XBRL (eXtensible Business Reporting Language) and furnished electronically herewith: (i) Condensed Consolidated Balance Sheets as of March 31, 2012 and December 31, 2011; (ii) Condensed Consolidated Statements of Operations for the three months ended March 31, 2012 and 2011; (iii) Condensed Consolidated Statement of Comprehensive Income for the three months ended March 31, 2012 and 2011; (iv) Condensed Consolidated Statement of Changes in Stockholders’ Equity for the three months ended March 31, 2012; (v) Condensed Consolidated Statements of Cash Flows for the three months ended March 31, 2012 and 2011; and (vi) Notes to Condensed Consolidated Financial Statements.

The certification attached as Exhibit 32.1 that accompanies this Quarterly Report on Form 10-Q is not deemed filed with the Securities and Exchange Commission and is not to be incorporated by reference into any filing of Vanda Pharmaceuticals Inc. under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended, whether made before or after the date of this Quarterly Report on Form 10-Q, irrespective of any general incorporation language contained in such filing.

 

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