Document_and_Entity_Informatio
Document and Entity Information (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Mar. 06, 2015 | Jun. 30, 2014 | |
Document Information [Line Items] | |||
Document Type | 10-K | ||
Amendment Flag | FALSE | ||
Document Period End Date | 31-Dec-14 | ||
Document Fiscal Year Focus | 2014 | ||
Document Fiscal Period Focus | FY | ||
Trading Symbol | VNDA | ||
Entity Registrant Name | Vanda Pharmaceuticals Inc. | ||
Entity Central Index Key | 1347178 | ||
Current Fiscal Year End Date | -19 | ||
Entity Well-known Seasoned Issuer | No | ||
Entity Current Reporting Status | Yes | ||
Entity Voluntary Filers | No | ||
Entity Filer Category | Accelerated Filer | ||
Entity Common Stock, Shares Outstanding | 41,641,005 | ||
Entity Public Float | $380,600,000 |
Consolidated_Balance_Sheets
Consolidated Balance Sheets (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ||
Cash and cash equivalents | $60,901 | $64,764 |
Marketable securities | 68,921 | 65,586 |
Accounts receivable, net | 3,654 | 2,031 |
Inventory | 5,170 | |
Prepaid expenses and other current assets | 3,084 | 2,703 |
Restricted cash | 530 | |
Total current assets | 141,730 | 135,614 |
Property and equipment, net | 2,437 | 2,198 |
Intangible assets, net | 26,724 | 5,037 |
Restricted cash, non-current | 785 | 500 |
Other assets, non-current | 28 | |
Total assets | 171,704 | 143,349 |
Current liabilities: | ||
Accounts payable | 835 | 661 |
Accrued liabilities | 6,502 | 5,180 |
Deferred rent | 247 | 221 |
Deferred revenues | 174 | 26,789 |
Other liabilities | 28 | |
Total current liabilities | 7,786 | 32,851 |
Deferred rent, non-current | 3,101 | 2,888 |
Deferred revenues, non-current | 63,486 | |
Total liabilities | 10,887 | 99,225 |
Commitments and contingencies (Note 14 and 21) | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 20,000,000 shares authorized, and no shares issued or outstanding | ||
Common stock, $0.001 par value; 150,000,000 shares authorized; 41,486,361 and 33,338,543 shares issued and outstanding at December 31, 2014 and 2013, respectively | 41 | 33 |
Additional paid-in capital | 448,744 | 352,240 |
Accumulated other comprehensive income | 16 | 21 |
Accumulated deficit | -287,984 | -308,170 |
Total stockholders' equity | 160,817 | 44,124 |
Total liabilities and stockholders' equity | $171,704 | $143,349 |
Consolidated_Balance_Sheets_Pa
Consolidated Balance Sheets (Parenthetical) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
Preferred stock, par value | $0.00 | $0.00 |
Preferred stock, shares authorized | 20,000,000 | 20,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $0.00 | $0.00 |
Common stock, shares authorized | 150,000,000 | 150,000,000 |
Common stock, shares issued | 41,486,361 | 33,338,543 |
Common stock, shares outstanding | 41,486,361 | 33,338,543 |
Consolidated_Statements_of_Ope
Consolidated Statements of Operations (USD $) | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Revenues: | |||
Net product sales | $12,909 | ||
Royalty revenue | 6,502 | 7,090 | 5,938 |
Licensing agreement | 30,746 | 26,789 | 26,789 |
Total revenues | 50,157 | 33,879 | 32,727 |
Operating expenses: | |||
Cost of goods sold | 1,583 | 129 | |
Research and development | 19,230 | 28,502 | 45,764 |
Selling, general and administrative | 84,644 | 25,082 | 14,517 |
Intangible asset amortization | 2,254 | 1,495 | 1,495 |
Gain on arbitration settlement | -77,616 | ||
Total operating expenses | 30,095 | 55,079 | 61,905 |
Income (loss) from operations | 20,062 | -21,200 | -29,178 |
Other income | 124 | 145 | 561 |
Net income (loss) | $20,186 | ($21,055) | ($28,617) |
Net income (loss) per share: | |||
Basic | $0.58 | ($0.69) | ($1.01) |
Diluted | $0.55 | ($0.69) | ($1.01) |
Weighted average shares outstanding: | |||
Basic | 34,774,163 | 30,351,353 | 28,228,409 |
Diluted | 36,686,723 | 30,351,353 | 28,228,409 |
Consolidated_Statements_of_Com
Consolidated Statements of Comprehensive Income (Loss) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||||||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | ||||
Net income (loss) | $69,719 | ($1,426) | ($21,575) | ($26,533) | ($7,747) | [1] | ($5,406) | [1] | ($3,383) | [1] | ($4,519) | [1] | $20,186 | ($21,055) | ($28,617) |
Other comprehensive income (loss): | |||||||||||||||
Change in net unrealized gain (loss) on marketable securities | -5 | 11 | -11 | ||||||||||||
Tax provision on other comprehensive income (loss) | 0 | 0 | 0 | ||||||||||||
Other comprehensive income (loss), net of tax: | -5 | 11 | -11 | ||||||||||||
Comprehensive income (loss) | $20,181 | ($21,044) | ($28,628) | ||||||||||||
[1] | In the first quarter of 2014, the Company elected to change its method of accounting for stock-based compensation from the accelerated attribution method to the straight-line method. The consolidated financial data above for the year ended 2013 has been adjusted to reflect this change. See Note 4, Change in Method of Accounting for Stock-based Compensation, for further discussion. |
Statements_of_Changes_in_Stock
Statements of Changes in Stockholders' Equity (USD $) | Total | Common Stock | Additional Paid-in Capital | Other Comprehensive Income (Loss) | Accumulated Deficit |
In Thousands, except Share data | |||||
Beginning balance at Dec. 31, 2011 (As Previously Reported) | $33,474 | $28 | $296,868 | $21 | ($263,443) |
Beginning balance (Retrospective Adjustment) | -4,945 | 4,945 | |||
Beginning balance at Dec. 31, 2011 | 33,474 | 28 | 291,923 | 21 | -258,498 |
Beginning balance (in shares) at Dec. 31, 2011 (As Previously Reported) | 28,117,026 | ||||
Beginning balance (in shares) at Dec. 31, 2011 | 28,117,026 | ||||
Issuance of common stock from the exercise of stock options and settlement of restricted stock units (in shares) | 124,717 | ||||
Issuance of common stock from the exercise of stock options and settlement of restricted stock units | 12 | 12 | |||
Employee and non-employee stock based compensation expense | 5,047 | 5,047 | |||
Net income (loss) | -28,617 | -28,617 | |||
Other comprehensive income (loss), net of tax | -11 | -11 | |||
Ending balance at Dec. 31, 2012 | 9,905 | 28 | 296,982 | 10 | -287,115 |
Ending balance (in shares) at Dec. 31, 2012 | 28,241,743 | ||||
Net proceeds from public offering of common stock (in shares) | 4,680,000 | ||||
Net proceeds from public offering of common stock | 48,505 | 5 | 48,500 | ||
Issuance of common stock from the exercise of stock options and settlement of restricted stock units (in shares) | 466,320 | ||||
Issuance of common stock from the exercise of stock options and settlement of restricted stock units | 1,550 | 1,550 | |||
Shares withheld upon settlement of restricted stock units (in shares) | -49,520 | ||||
Shares withheld upon settlement of restricted stock units | -196 | -196 | |||
Employee and non-employee stock based compensation expense | 5,404 | 5,404 | |||
Net income (loss) | -21,055 | -21,055 | |||
Other comprehensive income (loss), net of tax | 11 | 11 | |||
Ending balance at Dec. 31, 2013 | 44,124 | 33 | 352,240 | 21 | -308,170 |
Ending balance (in shares) at Dec. 31, 2013 | 33,338,543 | ||||
Net proceeds from public offering of common stock (in shares) | 5,750,000 | ||||
Net proceeds from public offering of common stock | 62,313 | 5 | 62,308 | ||
Issuance of common stock to Novartis Pharma AG (in shares) | 1,808,973 | ||||
Issuance of common stock to Novartis Pharma AG | 25,905 | 2 | 25,903 | ||
Issuance of common stock from the exercise of stock options and settlement of restricted stock units (in shares) | 621,231 | ||||
Issuance of common stock from the exercise of stock options and settlement of restricted stock units | 2,852 | 1 | 2,851 | ||
Shares withheld upon settlement of restricted stock units (in shares) | -32,386 | -32,386 | |||
Shares withheld upon settlement of restricted stock units | -436 | -436 | |||
Employee and non-employee stock based compensation expense | 5,878 | 5,878 | |||
Net income (loss) | 20,186 | 20,186 | |||
Other comprehensive income (loss), net of tax | -5 | -5 | |||
Ending balance at Dec. 31, 2014 | $160,817 | $41 | $448,744 | $16 | ($287,984) |
Ending balance (in shares) at Dec. 31, 2014 | 41,486,361 |
Consolidated_Statements_of_Cas
Consolidated Statements of Cash Flows (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Cash flows from operating activities | |||
Net income (loss) | $20,186 | ($21,055) | ($28,617) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization of property and equipment | 530 | 432 | 633 |
Employee and non-employee stock-based compensation | 5,878 | 5,404 | 5,047 |
Amortization of discounts and premiums on marketable securities | 174 | 155 | 560 |
Intangible asset amortization | 2,254 | 1,495 | 1,495 |
Gain on arbitration settlement with Novartis Pharma AG | -77,616 | ||
Landlord contributions for tenant improvements | 1,826 | ||
Changes in assets and liabilities: | |||
Accounts receivable | -1,623 | -863 | 450 |
Prepaid expenses and other current assets | -290 | 1,264 | -884 |
Inventory | -2,210 | ||
Other assets | -28 | ||
Accounts payable | 174 | 374 | -709 |
Accrued liabilities | 1,322 | -113 | 1,806 |
Other liabilities | 267 | 104 | 265 |
Deferred revenue | -30,572 | -26,789 | -26,789 |
Net cash used in operating activities | -81,554 | -39,592 | -44,917 |
Cash flows from investing activities | |||
Acquisition of intangible assets | -8,000 | ||
Purchases of property and equipment | -769 | -176 | -2,017 |
Purchases of marketable securities | -93,343 | -65,598 | -60,866 |
Proceeds from sale of marketable securities | 8,948 | 2,497 | |
Maturities of marketable securities | 80,882 | 31,499 | 106,140 |
Change in restricted cash | 245 | ||
Net cash (used in) provided by investing activities | -12,037 | -34,275 | 45,754 |
Cash flows from financing activities | |||
Net proceeds from offering of common stock | 62,313 | 48,505 | |
Tax obligations paid in connection with settlement of restricted stock units | -436 | -196 | |
Proceeds from exercise of employee stock options | 2,851 | 1,550 | 12 |
Net cash provided by financing activities | 89,728 | 49,859 | 12 |
Net increase (decrease) in cash and cash equivalents | -3,863 | -24,008 | 849 |
Cash and cash equivalents | |||
Beginning of period | 64,764 | 88,772 | 87,923 |
End of period | 60,901 | 64,764 | 88,772 |
Non-cash investing and financing activities | |||
Intangible asset related to re-acquired right to Fanapt B. | -15,940 | ||
Inventories | 2,960 | ||
Prepaid services | 91 | ||
Purchase of property and equipment in accrued liabilities | 106 | ||
Novartis Pharma AG | |||
Cash flows from financing activities | |||
Net proceeds from offering of common stock | $25,000 |
Business_Organization_and_Pres
Business Organization and Presentation | 12 Months Ended | |||
Dec. 31, 2014 | ||||
Business Organization and Presentation | 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 and the Company’s portfolio includes the following products. | ||||
• | HETLIOZ® (tasimelteon), a product for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) for which a New Drug Application (NDA) was approved by the U.S. Food and Drug Administration (FDA) in January 2014 and launched commercially in the U.S. in April 2014. | |||
• | Fanapt® (iloperidone), a product for the treatment of schizophrenia, the oral formulation of which was being marketed and sold in the U.S. by Novartis Pharma AG (Novartis) until December 31, 2014. On December 31, 2014, Novartis transferred all the U.S. and Canadian commercial rights to the Fanapt® franchise to the Company. See Note 3, Settlement Agreement with Novartis, for further information. Additionally, the Company’s distribution partners launched Fanapt® in Israel and Mexico in 2014. | |||
• | Tradipitant (VLY-686), a small molecule neurokinin-1 receptor (NK-1R) antagonist, which is presently in clinical development for the treatment of chronic pruritus in atopic dermatitis. Results from a Phase II study for the treatment of chronic pruritus in atopic dermatitis were announced in March 2015. Clinical evaluation is ongoing to assess potential future development activities. | |||
• | Trichostatin A, a small molecule histone deacetylase (HDAC) inhibitor. | |||
• | AQW051, a Phase II alpha-7 nicotinic acetylcholine receptor partial agonist. | |||
Basis of presentation | ||||
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America. All intercompany accounts and transactions have been eliminated in consolidation. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies | ||||||||||||
Use of estimates | |||||||||||||
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America 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 consolidated balance sheets and 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 consolidated statements of operations when generated. Marketable securities with a maturity of more than one year as of the balance sheet date and 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. | |||||||||||||
Inventory | |||||||||||||
Inventory, which is recorded at the lower of cost or market, includes the cost of third-party manufacturing and other direct and indirect costs and is valued using the first-in, first-out method. The Company capitalizes inventory costs associated with its products upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed as research and development. Inventory is evaluated for impairment by consideration of factors such as lower of cost or market, net realizable value, obsolescence or expiry. | |||||||||||||
Intangible asset | |||||||||||||
Costs incurred for products not yet approved by the FDA and for which no alternative future use exists are recorded as expense. In the event a product has been approved by the FDA or an alternative future use exists for a product, patent and license costs are capitalized and amortized over the expected patent life of the related product. Milestone payments to the Company’s partners are recognized when it is deemed probable that the milestone event will occur. | |||||||||||||
Property and equipment | |||||||||||||
Property and equipment are stated at cost less accumulated depreciation and amortization. The costs of leasehold improvements funded by or reimbursed by the lessor are capitalized and amortized as leasehold improvements along with a corresponding deferred rent liability. 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 statement of operations for that period. | |||||||||||||
Accrued liabilities | |||||||||||||
The Company’s management is required to estimate accrued liabilities as part of the process of preparing financial statements. The estimation of accrued liabilities 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 liabilities 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: (i) an evaluation by the project manager of the work that has been completed during the period, (ii) measurement of progress prepared internally and/or provided by the third-party service provider, (iii) analyses of data that justify the progress, and (iv) 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. | |||||||||||||
Net Product Sales | |||||||||||||
The Company’s 2014 net product sales consist of U.S. sales of HETLIOZ® for the treatment of Non-24 and sales of Fanapt® in Israel. The Company applies the revenue recognition guidance in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Subtopic 605-15, Revenue Recognition—Products. The Company recognizes revenue from product sales when there is persuasive evidence that an arrangement exists, title to product and associated risk of loss has passed to the customer, the price is fixed or determinable, collectability is reasonably assured and the Company has no further performance obligations. | |||||||||||||
In the U.S., HETLIOZ® is only available for distribution through a limited number of specialty pharmacies, and is not available in retail pharmacies. The Company invoices and records revenue when the specialty pharmacies receive HETLIOZ® from the third-party logistics warehouse. | |||||||||||||
The Company has entered into distribution agreements with Probiomed S.A. de C.V. (Probiomed) for the commercialization of Fanapt® in Mexico and Megapharm Ltd. for the commercialization of Fanapt® in Israel. With the exception of sales to Probiomed, the Company invoices and records revenue upon delivery of Fanapt® to the distribution partner. The Probiomed distribution agreement contains a contracted delivery price plus a revenue sharing provision based on Probiomed’s sales of Fanapt®. As a result, the selling price of Fanapt® is not fixed or determinable upon delivery of Fanapt® to Probiomed. The Company defers revenue recognition until the revenue sharing provision is calculated. As of December 31, 2014, the Company recorded $0.2 million of deferred revenue related to Fanapt® sales. | |||||||||||||
Product Sales Discounts and Allowances | |||||||||||||
HETLIOZ® product sales revenue is recorded net of applicable discounts, chargebacks, rebates, co-pay assistance, service fees and product returns that are applicable for various government and commercial payors. Reserves established for discounts and returns are classified as reductions of accounts receivable if the amount is payable to direct customers, with the exception of service fees. Service fees are classified as a liability. Reserves established for chargebacks, rebates or co-pay assistance are classified as a liability if the amount is payable to a party other than customers. The Company currently records sales allowances for the following: | |||||||||||||
Rebates: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with public sector benefit providers, such as Medicaid. The allowance for rebates is based on statutory discount rates and expected utilization. Estimates for the expected utilization of rebates are based in part on actual and pending prescriptions for which the Company has validated the insurance benefits. Rebates are generally invoiced and paid in arrears, such that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarter’s unpaid rebates. | |||||||||||||
Chargebacks: Chargebacks are discounts that occur when contracted customers purchase directly from specialty pharmacies. Contracted customers, which currently consist primarily of Public Health Service institutions, non-profit clinics, and Federal government entities purchasing via the Federal Supply Schedule, generally purchase the product at a discounted price. The specialty pharmacy, in turn, charges back the difference between the price initially paid by the specialty pharmacy and the discounted price paid to the specialty pharmacy by the contracted customer. The allowance for chargebacks is based on actual and pending prescriptions for which the Company has validated the insurance benefits. | |||||||||||||
Medicare Part D Coverage Gap: Medicare Part D prescription drug benefit mandates manufacturers to fund approximately 50% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Estimates for expected Medicare Part D coverage gap are based in part on historical invoices received and on actual and pending prescriptions for which the Company has validated the insurance benefits. Funding of the coverage gap is generally invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarter activity. If actual future funding varies from estimates, the Company may need to adjust accruals, which would affect net revenue in the period of adjustment. | |||||||||||||
Service Fees: The Company also incurs specialty pharmacy fees for services and their data. These fees are based on contracted terms and are known amounts. The Company accrues service fees at the time of revenue recognition, resulting in a reduction of product sales revenue and the recognition of an accrued liability, unless it receives an identifiable and separate benefit for the consideration and it can reasonably estimate the fair value of the benefit received. In which case, service fees are recorded as selling, general and administrative expense. | |||||||||||||
Co-payment Assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. Co-pay assistance utilization is based on information provided by the Company’s third-party administrator. The allowance for co-pay assistance is based on actual and pending sales for which the Company has validated the insurance benefits. | |||||||||||||
Prompt-pay: Specialty pharmacies are offered discounts for prompt payment. The Company expects that the specialty pharmacy will earn prompt payment discounts and, therefore, deducts the full amount of these discounts from total product sales when revenues are recognized. | |||||||||||||
Product Returns: Consistent with industry practice, the Company generally offers direct customers a limited right to return as defined within the Company’s returns policy. The Company considers several factors in the estimation process, including expiration dates of product shipped to specialty pharmacies, inventory levels within the distribution channel, product shelf life, prescription trends and other relevant factors. | |||||||||||||
There were no discounts or rebates associated with Fanapt® product sales recognized in the period. The Company’s partners have a limited right to return Fanapt®. Once Fanapt® has been delivered to the partners it generally may not be returned for any reason other than product recall. | |||||||||||||
License Revenue | |||||||||||||
The Company’s license revenues were derived from the amended and restated sublicense agreement with Novartis and include an upfront payment and future milestone and royalty payments. Pursuant to the amended and restated sublicense agreement, Novartis had 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. Revenue related to the upfront payment was recognized ratably from the date the amended and restated sublicense agreement became effective (November 2009) through the expected duration of the Novartis commercialization of Fanapt® in the U.S. which was estimated to be through the expiry of the Fanapt® composition of patent, including a granted Hatch-Waxman extension (November 2016). In connection with the Settlement Agreement with Novartis, the Company recognized the remaining deferred revenue as of December 31, 2014 as part of the gain on arbitration settlement. See Note 3, Settlement Agreement with Novartis, for further discussion. | |||||||||||||
Cost of goods sold | |||||||||||||
Cost of goods sold includes royalties payable, the cost of inventory sold, manufacturing and supply chain costs and product shipping and handling costs related to U.S. sales of HETLIOZ® and sales of Fanapt® to the Company’s distribution partners. | |||||||||||||
Research and development expenses | |||||||||||||
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 payments, 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 research and development personnel. The Company expenses research and development costs as they are incurred for products in the development stage, including manufacturing costs and milestone payments made under license agreements prior to FDA approval. Upon and subsequent to FDA approval, manufacturing and milestone payments related to license agreements are capitalized. Milestone payments are accrued when it is deemed probable that the milestone event will be achieved. Costs related to the acquisition of intellectual property are expensed as incurred if the underlying technology is developed in connection with the Company’s research and development efforts and has no alternative future use. | |||||||||||||
Selling, general and administrative expenses | |||||||||||||
Selling, general and administrative expenses consist of salaries, including employee stock-based compensation, facilities and third party expenses. Selling, general and administrative expenses are associated with the activities of the executive, finance, accounting, information technology, business development, commercial support, trade and distribution, sales, marketing, legal, medical affairs and human resource functions. | |||||||||||||
Employee stock-based compensation | |||||||||||||
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. | |||||||||||||
In January 2014, the Company elected to change its method of accounting for the attribution of compensation cost for stock options with graded-vesting and only service conditions to the straight-line method. Previously, attribution was based on the accelerated attribution method, which treated each vesting tranche as an individual award and amortized them concurrently. See Note 4, Change in Method of Accounting for Stock-based Compensation, for further information. The fair value of restricted stock units (RSUs) awarded is also amortized using the straight line method. Stock-based compensation expense recognized in the consolidated statements of operations is based on awards ultimately expected to vest. Therefore, 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. | |||||||||||||
Total employee stock-based compensation expense recognized for the years ended December 31, 2014, 2013 and 2012 was comprised of the following: | |||||||||||||
Year Ended December 31, | |||||||||||||
(in thousands) | 2014 | 2013 | 2012 | ||||||||||
Research and development | $ | 1,810 | $ | 2,098 | $ | 1,673 | |||||||
Selling, general and administrative | 3,945 | 3,238 | 3,353 | ||||||||||
$ | 5,755 | $ | 5,336 | $ | 5,026 | ||||||||
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. Expected volatility rates are based on the historical volatility of the Company’s publicly traded common stock and other factors. Beginning in 2014, the Company started using a mid-point scenario to calculate the weighted average expected term of stock options granted, which combines the Company’s historical exercise data with hypothetical exercise data for unexercised stock options. Prior to 2014, the expected term assumption was determined using the simplified 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. The Company has not paid dividends to its stockholders since its inception (other than a dividend of preferred share purchase rights, which was declared in September 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 years ended December 31, 2014, 2013 and 2012 were as follows: | |||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Expected dividend yield | 0 | % | 0 | % | 0 | % | |||||||
Weighted average expected volatility | 62 | % | 65 | % | 68 | % | |||||||
Weighted average expected term (years) | 5.9 | 6.03 | 6.03 | ||||||||||
Weighted average risk-free rate | 1.73 | % | 1.59 | % | 0.94 | % | |||||||
Weighted average fair value per share | $ | 6.99 | $ | 6.1 | $ | 2.08 | |||||||
Advertising Expense | |||||||||||||
The Company expenses the costs of advertising, including branded promotional expenses, as incurred. Branded advertising expenses, recorded in selling, general and administrative expenses, were $5.0 million for the year ended December 31, 2014. The Company did not incur any advertising expense during the years ended December 31, 2013 and 2012. | |||||||||||||
Income taxes | |||||||||||||
The Company accounts for income taxes in accordance with the authoritative guidance 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. The fact that the Company has historically generated net operating losses (NOLs) serves as strong evidence that it is more likely than not that deferred tax assets will not be realized in the future. Therefore, the Company has a full valuation allowance against all deferred tax assets as of December 31, 2014 and 2013, respectively. Tax rate changes are reflected in income during the period such changes are enacted. Changes in ownership may limit the amount of NOL carryforwards that can be utilized in the future to offset taxable income. | |||||||||||||
Certain risks and uncertainties | |||||||||||||
The Company’s products under development require approval from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance the products will receive the necessary clearance. If the Company is denied clearance or clearance is delayed, it may have a material adverse impact on the Company. | |||||||||||||
The Company’s products are concentrated in rapidly-changing, highly-competitive markets, which are characterized by rapid technological advances, changes in customer requirements and evolving regulatory requirements and industry standards. Any failure by the Company to anticipate or to respond adequately to technological developments in its industry, changes in customer requirements or changes in regulatory requirements or industry standards or any significant delays in the development or introduction of products or services could have a material adverse effect on the Company’s business, operating results and future cash flows. | |||||||||||||
The Company depends on single source suppliers for critical raw materials for manufacturing, as well as other components required for the administration of its products. The loss of these suppliers could delay the clinical trials or prevent or delay commercialization of the products. | |||||||||||||
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 highly-rated financial institutions. At December 31, 2014, 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. | |||||||||||||
Segment information | |||||||||||||
The Company’s management has determined that the Company operates in one business segment which is the development and commercialization of pharmaceutical products. | |||||||||||||
Recent accounting pronouncements | |||||||||||||
In January 2015, the FASB issued Accounting Standards Update (ASU) 2015-01, Income Statement-Extraordinary and Unusual Items, to simplify income statement classification by removing the concept of extraordinary items from U.S. GAAP. As a result, items that are both unusual and infrequent will no longer be separately reported net of tax after continuing operations. The new standard is effective for both public and private companies for periods beginning after December 15, 2015. Adoption of this new standard is not expected to have a material impact on the Company’s condensed consolidated financial statements. | |||||||||||||
In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements—Going Concern. The new standard requires management of public and private companies to evaluate whether there is substantial doubt about the entity’s ability to continue as a going concern and, if so, disclose that fact. Management will also be required to evaluate and disclose whether its plans alleviate that doubt. The new standard is effective for annual periods ending after December 15, 2016, and interim periods within annual periods beginning after December 15, 2016. Adoption of this new standard is not expected to have a material impact on the Company’s condensed consolidated financial statements. | |||||||||||||
In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). This new standards requires companies to recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which a company expects to be entitled in exchange for those goods or services. Under the new standard, revenue is recognized when a customer obtains control of a good or service. The standard allows for two transition methods—entities can either apply the new standard (i) retrospectively to each prior reporting period presented, or (ii) retrospectively with the cumulative effect of initially applying the standard recognized at the date of initial adoption. The new standard is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2016. Early adoption of the standard is prohibited. The Company is evaluating this standard to determine if adoption will have a material impact on the Company’s condensed consolidated financial statements. | |||||||||||||
In July 2013, the FASB issued ASU 2013-11, Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists. This new standard requires the netting of unrecognized tax benefits against a deferred tax asset for a loss or other carryforward that would apply in settlement of the uncertain tax positions. Under the new standard, unrecognized tax benefits will be netted against all available same-jurisdiction loss or other tax carryforwards that would be utilized, rather than only against carryforwards that are created by the unrecognized tax benefits. The new standard is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2013. Adoption of this new standard did not have a material impact on the Company’s condensed consolidated financial statements. |
Settlement_Agreement_with_Nova
Settlement Agreement with Novartis | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Settlement Agreement with Novartis | 3. Settlement Agreement with Novartis | ||||||||
In May 2014, the Company commenced arbitration proceedings with Novartis relating to the license of Fanapt® (the Fanapt® Arbitration). In December 2014, the Company entered into a settlement agreement with Novartis and certain of its affiliates (the Settlement Agreement). Pursuant to the terms of the Settlement Agreement, the Company and Novartis dismissed the Fanapt® Arbitration and released each other from any related claims. In addition, in connection with the Settlement Agreement, Novartis (i) transferred all U.S. and Canadian rights in the Fanapt® franchise to the Company, (ii) purchased $25.0 million of the Company’s common stock at a price per share equal to $13.82, and (iii) granted to the Company an exclusive worldwide license to AQW051, a Phase II alpha-7 nicotinic acetylcholine receptor partial agonist. | |||||||||
Pursuant to the stock purchase agreement entered into as part of the Settlement Agreement, Novartis purchased $25.0 million of the Company’s common stock. The Company issued to Novartis an aggregate of 1,808,973 shares at $13.82 per share, which per share represented a 10% premium to the average closing prices of the Company’s common stock for the ten trading days prior to December 22, 2014. The Company recorded a loss of $0.9 million as part of gain on arbitration settlement in the consolidated statement of operations for the period ending December 31, 2014 related to the issuance of stock, which was valued using the Company’s closing stock price on December 31, 2014, the effective date of the transaction. | |||||||||
In connection with the Settlement Agreement, the Company received an exclusive worldwide license under certain patents and patent applications, and other licenses to intellectual property, to develop and commercialize AQW051. Under the AQW051 license agreement, the Company is obligated to use its commercially reasonable efforts to develop and commercialize AQW051 and is responsible for all development costs under the AQW051 license agreement. Novartis is eligible to receive tiered-royalties on net sales at percentage rates up to the mid-teens. The Company evaluated AQW051 and determined that the asset is both incomplete and has substance. However, given the early stage of AQW051 and the future costs of development, no transaction value was allocated to this asset. | |||||||||
The Company accounted for the Settlement Agreement in accordance with the provisions of ASC Subtopic 805, Business Combinations (ASC 805). Under the provisions of ASC 805, the acquisition date for a business is the date on which the company obtains control of the acquiree. The Company obtained control on December 31, 2014, the effective date of the Settlement Agreement. The following summarizes the fair value of consideration exchanged as part of the Settlement Agreement: | |||||||||
(in thousands) | |||||||||
Equity issued | $ | 25,904 | |||||||
Cash received | (25,000 | ) | |||||||
Settlement of pre-existing non-contractual relationship | 18,087 | ||||||||
$ | 18,991 | ||||||||
Assets acquired and recorded at fair value as of December 31, 2014 were as follows: | |||||||||
(in thousands) | |||||||||
Inventory | $ | 2,960 | |||||||
Intangible—Re-acquired right | 15,940 | ||||||||
Prepaid services | 91 | ||||||||
$ | 18,991 | ||||||||
The Company recorded the reacquired right as an intangible asset as of December 31, 2014. The Company is amortizing the reacquired right on a straight-line basis through November 2016. See Note 11, Intangible Assets, for further discussion. | |||||||||
Due to the effective date of the Settlement Agreement being December 31, 2014, the Company did not recognize any revenue or operating expenses related to U.S. or Canadian commercial sales of Fanapt® in the consolidated statement of operations for the period ending December 31, 2014. Non-recurring transaction costs of $0.6 million related to the acquisition are recorded in selling, general and administrative expenses in the consolidated statement of operations for the period ending December 31, 2014. | |||||||||
In connection with the Settlement Agreement, the Company and Novartis terminated the 2009 Amended Sublicense Agreement (the 2009 Agreement). Given the termination of this pre-existing contractual relationship and that there is no further obligations under the 2009 Agreement, the Company recognized a gain of $59.5 million, representing the remaining deferred revenue related to the $200.0 million upfront payment received from Novartis under the 2009 Agreement. This amount is included in gain on arbitration settlement in the consolidated statement of operations for the period ending December 31, 2014. | |||||||||
The Settlement Agreement provided for mutual release of claims and dismissed the Fanapt® Arbitration, which effectively settled a pre-existing non-contractual relationship. As a result, the Company recorded an $18.1 million gain on the settlement of arbitration, which represented the value of a potential future arbitration outcome. This amount was valued based on a probability weighted scenario analysis that took into consideration the probability of each potential future alternative outcomes of the arbitration between the parties. This amount is included in gain on arbitration settlement in the consolidated statement of operations for the period ending December 31, 2014. | |||||||||
Unaudited Pro forma Information | |||||||||
The following supplemental pro forma information summarizes the combined results of operations of the Company and the Fanapt® business as though the acquisition occurred on January 1, 2013. These supplemental pro forma results of operations are provided for illustrative purposes only and do not purport to be indicative of the actual results that would have been achieved by the combined company for the periods presented or that may be achieved by the combined company in the future. The pro forma results do not include any cost savings or other synergies that may result from the Fanapt® acquisition or any estimated costs that will be incurred to integrate Fanapt® into the Company. Future results may vary significantly from the results in this pro forma information because of future unknown events. | |||||||||
Year Ended December 31, | |||||||||
(in thousands, except per share amounts) | 2014 | 2013 | |||||||
Revenue | $ | 79,335 | $ | 75,270 | |||||
Net income (loss) | $ | (100,742 | ) | $ | 41,048 | ||||
Basic income (loss) per share | $ | (2.90 | ) | $ | 1.35 | ||||
Diluted income (loss) per share | $ | (2.90 | ) | $ | 1.29 | ||||
The Company’s historical financial information was adjusted to give effect to the pro forma events that were directly attributable to the Fanapt® business. The pro forma consolidated results include historical revenues and expenses for the both the Company and the Fanapt® business with the following adjustments: | |||||||||
• | The timing of the gain on arbitration settlement as of January 1, 2013. | ||||||||
• | The increase to the gain on arbitration settlement due to the larger deferred revenue balance associated with the license agreement as of January 1, 2013. | ||||||||
• | The removal of licensing revenue from the Company’s revenue associated with the up-front license fee received from Novartis. | ||||||||
• | The inclusion of intangible asset amortization expense associated with the intangible asset recorded as part of the acquisition. | ||||||||
• | The removal of the royalty associated with U.S. sales of Fanapt® from both the Company’s revenue and the expenses of the Fanapt® business. | ||||||||
• | The difference between the cost of inventory that Novartis incurred and the Company’s recorded fair value of inventory. |
Change_in_Method_of_Accounting
Change in Method of Accounting for Stock-based Compensation | 12 Months Ended | ||||||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||||||
Change in Method of Accounting for Stock-based Compensation | 4. Change in Method of Accounting for Stock-based Compensation | ||||||||||||||||||||||||
In January 2014, the Company elected to change its method of accounting for the attribution of compensation cost for stock options with graded-vesting and only service conditions to the straight-line method. Previously, attribution was based on the accelerated attribution method, which treated each vesting tranche as an individual award and amortized them concurrently. The straight-line method of accounting was adopted to better align the Company’s recognition of stock option compensation cost with its peers and to expense stock options and RSUs in a consistent manner. Comparative financial statements for prior periods have been adjusted to apply the straight-line method retrospectively. As a result of the change in method of accounting for stock-based compensation, the expense for stock-based compensation related to option awards was $2.2 million lower than it would have been under the accelerated attribution method for the year ended December 31, 2014. This resulted in an increase to net income of $2.2 million, or $0.06 per basic and diluted share for the year ended December 31, 2014. | |||||||||||||||||||||||||
There was no adjustment as a result of the change in method of accounting for stock-based compensation to amounts previously reported as assets, liabilities and total stockholders’ equity in the consolidated balance sheets for prior periods. However, amounts previously reported as additional paid-in capital and accumulated deficit for prior periods have been adjusted to reflect the change in method of accounting for stock-based compensation. The cumulative effect of the change on accumulated deficit as of January 1, 2012, the beginning of the earliest period presented in the financial statements was a reduction of $4.9 million. The adjustments as of December 31, 2011 were as follows: | |||||||||||||||||||||||||
Balance Sheet | |||||||||||||||||||||||||
December 31, 2011 | |||||||||||||||||||||||||
(in thousands, except for share and per share amounts) | As Previously | Retrospective | As | ||||||||||||||||||||||
Reported | Adjustment | Adjusted | |||||||||||||||||||||||
Stockholders’ equity: | |||||||||||||||||||||||||
Preferred stock, $0.001 par value; 20,000,000 shares authorized, and no shares issued or outstanding | — | — | |||||||||||||||||||||||
Common stock, $0.001 par value; 150,000,000 shares authorized; 28,117,026 shares issued and outstanding at December 31, 2011 | $ | 28 | $ | — | $ | 28 | |||||||||||||||||||
Additional paid-in capital | 296,868 | (4,945 | ) | 291,923 | |||||||||||||||||||||
Accumulated other comprehensive income | 21 | — | 21 | ||||||||||||||||||||||
Accumulated deficit | (263,443 | ) | 4,945 | (258,498 | ) | ||||||||||||||||||||
Total stockholders’ equity | $ | 33,474 | $ | — | $ | 33,474 | |||||||||||||||||||
The amounts previously reported in the consolidated statement of operations for research and development expense, selling, general and administrative expense and net loss for prior periods have been adjusted as a result of the change in method of accounting for stock-based compensation. The adjustments for the years ended December 31, 2013 and 2012 were as follows: | |||||||||||||||||||||||||
Statement of Operations | |||||||||||||||||||||||||
(in thousands, except for share and | Year Ended December 31, 2013 | Year Ended December 31, 2012 | |||||||||||||||||||||||
per share amounts) | As previously | Retrospective | As | As previously | Retrospective | As | |||||||||||||||||||
Reported | Adjustment | Adjusted | Reported | Adjustment | Adjusted | ||||||||||||||||||||
Revenues: | |||||||||||||||||||||||||
Licensing agreement | $ | 26,789 | $ | — | $ | 26,789 | $ | 26,789 | $ | — | $ | 26,789 | |||||||||||||
Royalty revenue | 7,090 | — | 7,090 | 5,938 | — | 5,938 | |||||||||||||||||||
Total revenues | 33,879 | — | 33,879 | 32,727 | — | 32,727 | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||||
Cost of goods sold | — | — | — | 129 | — | 129 | |||||||||||||||||||
Research and development | 28,190 | 312 | 28,502 | 45,446 | 318 | 45,764 | |||||||||||||||||||
Selling, general and administrative | 24,594 | 488 | 25,082 | 13,882 | 635 | 14,517 | |||||||||||||||||||
Intangible asset amortization | 1,495 | — | 1,495 | 1,495 | — | 1,495 | |||||||||||||||||||
Total operating expenses | 54,279 | 800 | 55,079 | 60,952 | 953 | 61,905 | |||||||||||||||||||
Loss from operations | (20,400 | ) | (800 | ) | (21,200 | ) | (28,225 | ) | (953 | ) | (29,178 | ) | |||||||||||||
Other income | 145 | — | 145 | 561 | — | 561 | |||||||||||||||||||
Loss before tax benefit | (20,255 | ) | (800 | ) | (21,055 | ) | (27,664 | ) | (953 | ) | (28,617 | ) | |||||||||||||
Tax benefit | — | — | — | — | — | — | |||||||||||||||||||
Net loss | $ | (20,255 | ) | $ | (800 | ) | $ | (21,055 | ) | $ | (27,664 | ) | $ | (953 | ) | $ | (28,617 | ) | |||||||
Basic and diluted net loss per share | $ | (0.67 | ) | $ | (0.02 | ) | $ | (0.69 | ) | $ | (0.98 | ) | $ | (0.03 | ) | $ | (1.01 | ) | |||||||
Weighted average shares outstanding, basic and diluted | 30,351,353 | — | 30,351,353 | 28,228,409 | — | 28,228,409 | |||||||||||||||||||
The amounts previously reported for net loss in the consolidated statement of comprehensive loss for prior periods have been adjusted as a result of the change in method of accounting for stock-based compensation. The adjustments for the years ended December 31, 2013 and 2012 were as follows: | |||||||||||||||||||||||||
Statement of Comprehensive Loss | |||||||||||||||||||||||||
Year Ended December 31, 2013 | Year Ended December 31, 2012 | ||||||||||||||||||||||||
(in thousands) | As Previously | Retrospective | As | As Previously | Retrospective | As | |||||||||||||||||||
Reported | Adjustment | Adjusted | Reported | Adjustment | Adjusted | ||||||||||||||||||||
Net loss | $ | (20,255 | ) | $ | (800 | ) | $ | (21,055 | ) | $ | (27,664 | ) | $ | (953 | ) | $ | (28,617 | ) | |||||||
Other comprehensive income (loss): | |||||||||||||||||||||||||
Change in net unrealized loss on marketable securities | 11 | — | 11 | (11 | ) | — | (11 | ) | |||||||||||||||||
Tax provision on other comprehensive income (loss) | — | — | — | — | — | — | |||||||||||||||||||
Other comprehensive income (loss), net of tax: | 11 | — | 11 | (11 | ) | — | (11 | ) | |||||||||||||||||
Comprehensive loss | $ | (20,244 | ) | $ | (800 | ) | $ | (21,044 | ) | $ | (27,675 | ) | $ | (953 | ) | $ | (28,628 | ) | |||||||
There was no adjustment to the amounts previously reported for net cash used in operating activities in the consolidated statements of cash flows for prior periods as a result of the change in method of accounting for stock-based compensation. However, the amounts previously reported as net loss and employee and non-employee stock-based compensation expense in cash flows from operating activities have been adjusted to reflect the change in method of accounting for stock-based compensation. The adjustments for the years ended December 31, 2013 and 2012 were as follows: | |||||||||||||||||||||||||
Statement of Cash Flows | |||||||||||||||||||||||||
Year Ended December 31, 2013 | Year Ended December 31, 2012 | ||||||||||||||||||||||||
(in thousands) | As Previously | Retrospective | As | As Previously | Retrospective | As | |||||||||||||||||||
Reported | Adjustment | Adjusted | Reported | Adjustment | Adjusted | ||||||||||||||||||||
Cash flows from operating activities | |||||||||||||||||||||||||
Net loss | $ | (20,255 | ) | $ | (800 | ) | $ | (21,055 | ) | $ | (27,664 | ) | $ | (953 | ) | $ | (28,617 | ) | |||||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||||||||||||||||
Depreciation and amortization of property and equipment | 432 | — | 432 | 633 | — | 633 | |||||||||||||||||||
Employee and non-employee stock-based compensation | 4,604 | 800 | 5,404 | 4,094 | 953 | 5,047 | |||||||||||||||||||
Amortization of discounts and premiums on marketable securities | 155 | — | 155 | 560 | — | 560 | |||||||||||||||||||
Intangible asset amortization | 1,495 | — | 1,495 | 1,495 | — | 1,495 | |||||||||||||||||||
Landlord contributions for tenant improvements | — | — | — | 1,826 | — | 1,826 | |||||||||||||||||||
Changes in assets and liabilities, net | (26,023 | ) | — | (26,023 | ) | (25,861 | ) | — | (25,861 | ) | |||||||||||||||
Net cash used in operating activities | $ | (39,592 | ) | $ | — | $ | (39,592 | ) | $ | (44,917 | ) | $ | — | $ | (44,917 | ) | |||||||||
Earnings_per_Share
Earnings per Share | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Earnings per Share | 5. 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 years ended December 31, 2014, 2013, and 2012: | |||||||||||||
Year Ended December 31, | |||||||||||||
(in thousands, except for share and per share amounts) | 2014 | 2013 | 2012 | ||||||||||
Numerator: | |||||||||||||
Net income (loss) | $ | 20,186 | $ | (21,055 | ) | $ | (28,617 | ) | |||||
Denominator: | |||||||||||||
Weighted average shares outstanding: Basic | 34,774,163 | 30,351,353 | 28,228,409 | ||||||||||
Effect of dilutive securities | 1,912,560 | — | — | ||||||||||
Weighted average shares outstanding: Diluted | 36,686,723 | 30,351,353 | 28,228,409 | ||||||||||
Net income (loss) per share, basic and diluted: | |||||||||||||
Basic | $ | 0.58 | $ | (0.69 | ) | $ | (1.01 | ) | |||||
Diluted | $ | 0.55 | $ | (0.69 | ) | $ | (1.01 | ) | |||||
Antidilutive securities excluded from calculations of diluted net income (loss) per share | 3,524,656 | 4,409,811 | 5,462,476 | ||||||||||
The Company incurred a net loss for each of the years ended December 31, 2013 and 2012 causing inclusion of any potentially dilutive securities to have an anti-dilutive effect, resulting in dilutive loss per share and basic loss per share attributable to common stockholders being equivalent. |
Marketable_Securities
Marketable Securities | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Marketable Securities | 6. Marketable Securities | ||||||||||||||||
The following is a summary of the Company’s available-for-sale marketable securities as of December 31, 2014, which all have contract maturities of less than one year: | |||||||||||||||||
(in thousands) | Amortized | Gross | Gross | Fair | |||||||||||||
Cost | Unrealized | Unrealized | Market | ||||||||||||||
Gains | Losses | Value | |||||||||||||||
U.S. Treasury and government agencies | $ | 30,618 | $ | 4 | $ | (4 | ) | $ | 30,618 | ||||||||
Corporate debt | $ | 38,287 | $ | 25 | $ | (9 | ) | $ | 38,303 | ||||||||
$ | 68,905 | $ | 29 | $ | (13 | ) | $ | 68,921 | |||||||||
The following is a summary of the Company’s available-for-sale marketable securities as of December 31, 2013: | |||||||||||||||||
(in thousands) | Amortized | Gross | Gross | Fair | |||||||||||||
Cost | Unrealized | Unrealized | Market | ||||||||||||||
Gains | Losses | Value | |||||||||||||||
U.S. Treasury and government agencies | $ | 31,557 | $ | 9 | $ | — | $ | 31,566 | |||||||||
Corporate debt | $ | 34,008 | $ | 18 | $ | (6 | ) | $ | 34,020 | ||||||||
$ | 65,565 | $ | 27 | $ | (6 | ) | $ | 65,586 | |||||||||
Accounts_Receivable
Accounts Receivable | 12 Months Ended |
Dec. 31, 2014 | |
Accounts Receivable | 7. Accounts Receivable |
Accounts receivable are recorded for product sales and royalty income and do not bear interest. As of December 31, 2014 and 2013, the Company recorded a royalty receivable from Novartis of $1.6 million and $2.0 million, respectively. The Company determines an allowance for doubtful accounts based on assessed customers’ ability to pay and economic trends. Such allowance is the Company’s best estimate of the amount of probable credit losses in the Company’s existing accounts receivable. The Company did not record any bad debt expense for the years ended December 31, 2014 2013 and 2012. At December 31, 2014 and 2013 the allowance for doubtful accounts was zero. |
Inventory
Inventory | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Inventory | 8. Inventory | ||||||||
The Company evaluates expiry risk by evaluating current and future product demand relative to product shelf life. The Company builds demand forecasts by considering factors such as, but not limited to, overall market potential, market share, market acceptance and patient usage. Inventory consisted of the following as of December 31, 2014 and December 31, 2013: | |||||||||
December 31, | |||||||||
(in thousands) | 2014 | 2013 | |||||||
Raw materials | $ | 198 | $ | — | |||||
Work-in-process | 1,326 | — | |||||||
Finished goods | 3,394 | — | |||||||
Deferred cost of goods sold | 252 | — | |||||||
Total | $ | 5,170 | $ | — | |||||
Prepaid_Expenses_and_Other_Cur
Prepaid Expenses and Other Current Assets | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Prepaid Expenses and Other Current Assets | 9. Prepaid Expenses and Other Current Assets | ||||||||
The following is a summary of the Company’s prepaid expenses and other current assets as of December 31, 2014 and 2013: | |||||||||
December 31, | |||||||||
(in thousands) | 2014 | 2013 | |||||||
Prepaid insurance | $ | 270 | $ | 167 | |||||
Prepaid manufacturing cost | 358 | — | |||||||
Other prepaid expenses and vendor advances | 2,302 | 2,408 | |||||||
Other current assets | 154 | 128 | |||||||
Total prepaid expenses and other current assets | $ | 3,084 | $ | 2,703 | |||||
Property_and_Equipment
Property and Equipment | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Property and Equipment | 10. Property and Equipment | ||||||||||||
The following is a summary of the Company’s property and equipment-at cost, as of December 31, 2014 and 2013: | |||||||||||||
Estimated | December 31, | ||||||||||||
Useful Life | |||||||||||||
(in thousands) | (Years) | 2014 | 2013 | ||||||||||
Computer equipment | 3 | $ | 1,316 | $ | 983 | ||||||||
Furniture and fixtures | 7 | 765 | 580 | ||||||||||
Leasehold improvements | 11 | 2,089 | 1,884 | ||||||||||
$ | 4,170 | $ | 3,447 | ||||||||||
Accumulated depreciation and amortization | $ | (1,733 | ) | $ | (1,249 | ) | |||||||
$ | 2,437 | $ | 2,198 | ||||||||||
Depreciation and amortization expense for the years ended December 31, 2014, 2013 and 2012 was $0.5 million, $0.4 million and $0.6 million, respectively. |
Intangible_Assets
Intangible Assets | 12 Months Ended | ||||||||||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||||||||||
Intangible Assets | 11. Intangible Assets | ||||||||||||||||||||||||||||
The following is a summary of the Company’s intangible assets as of December 31, 2014 and 2013: | |||||||||||||||||||||||||||||
Estimated Useful | December 31, 2014 | ||||||||||||||||||||||||||||
(in thousands) | Life | Gross Carrying | Accumulated | Net Carrying | |||||||||||||||||||||||||
Amount | Amortization | Amount | |||||||||||||||||||||||||||
HETLIOZ® | January 2033 | $ | 8,000 | $ | 539 | $ | 7,461 | ||||||||||||||||||||||
Fanapt® | November 2016 | $ | 27,941 | $ | 8,678 | $ | 19,263 | ||||||||||||||||||||||
Estimated | 31-Dec-13 | ||||||||||||||||||||||||||||
(in thousands) | Useful Life | Gross Carrying | Accumulated | Net Carrying | |||||||||||||||||||||||||
Amount | Amortization | Amount | |||||||||||||||||||||||||||
Fanapt® | Nov-16 | $ | 12,000 | $ | 6,963 | $ | 5,037 | ||||||||||||||||||||||
In January 2014, the Company announced that the FDA had approved the NDA for HETLIOZ®. As a result of this approval, the Company met a milestone under its license agreement with Bristol-Myers Squibb (BMS) that required the Company to make a license payment of $8.0 million to BMS. The $8.0 million is being amortized on a straight-line basis over the remaining life of the U.S. patent for HETLIOZ®, which prior to June 2014, the Company expected to last until December 2022. In June 2014, the Company received a notice of allowance from the U.S. Patent and Trademark Office for a patent covering the method of use of HETLIOZ®. The patent expires in January 2033, thereby potentially extending the exclusivity protection in the U.S. beyond the composition of matter patent. As a result of the patent allowance, the Company extended the estimated useful life of the U.S. patent for HETLIOZ® from December 2022 to January 2033. | |||||||||||||||||||||||||||||
In 2009, the Company announced that the FDA had approved the NDA for Fanapt®. As a result of this approval, the Company met a milestone under its original sublicense agreement with Novartis that required the Company to make a license 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 as of December 31, 2013 the Company expected to last until May 2017. This reflected the expected duration of the Novartis commercialization of Fanapt® in the U.S. which was estimated to be through the expiry of the Fanapt® composition of matter patent, including a granted Hatch-Waxman extension and an assumed additional six month pediatric extension. In February 2014, the Company became aware of events that led it to believe that Novartis would not complete the ongoing pediatric efficacy studies in a time that would enable it to receive the incremental six-month pediatric term extension. This resulted in a six-month reduction to the estimated patent life from May 2017 to November 2016. | |||||||||||||||||||||||||||||
Pursuant to the Settlement Agreement, Novartis transferred all U.S. and Canadian rights in the Fanapt® franchise to the Company. As a result, the Company recognized an intangible asset of $15.9 million on December 31, 2014 related to the reacquired right to Fanapt®, which is being amortized on a straight-line basis through November 2016. The useful life estimation for the Fanapt® intangible asset is based on the market participant methodology prescribed by ASC 805, and therefore does not reflect the impact of the Fanapt® patent number 8,586,610, which is solely owned by the Company and expires in 2027. See Note 3, Settlement Agreement with Novartis, for further discussion. | |||||||||||||||||||||||||||||
The intangible assets are being amortized over their estimated useful economic life using the straight line method. Amortization expense was $2.3 million, $1.5 million and $1.5 million for the years ended December 31, 2014, 2013 and 2012, respectively. | |||||||||||||||||||||||||||||
The following is a summary of the future intangible asset amortization schedule as of December 31, 2014: | |||||||||||||||||||||||||||||
(in thousands) | Total | 2015 | 2016 | 2017 | 2018 | 2019 | Thereafter | ||||||||||||||||||||||
HETLIOZ® | $ | 7,461 | $ | 411 | $ | 411 | $ | 411 | $ | 411 | $ | 411 | $ | 5,406 | |||||||||||||||
Fanapt® | 19,263 | 10,050 | 9,213 | — | — | — | — | ||||||||||||||||||||||
$ | 26,724 | $ | 10,461 | $ | 9,624 | $ | 411 | $ | 411 | $ | 411 | $ | 5,406 | ||||||||||||||||
Accrued_Liabilities
Accrued Liabilities | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Accrued Liabilities | 12. Accrued Liabilities | ||||||||
The following is a summary of the Company’s accrued liabilities as of December 31, 2014 and 2013: | |||||||||
December 31, | |||||||||
(in thousands) | 2014 | 2013 | |||||||
Accrued research and development expenses | $ | 1,759 | $ | 2,324 | |||||
Accrued consulting and other professional fees | 2,522 | 2,015 | |||||||
Compensation and employee benefits | 388 | 176 | |||||||
Other accrued liabilities | 1,833 | 665 | |||||||
$ | 6,502 | $ | 5,180 | ||||||
Deferred_Revenue
Deferred Revenue | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Deferred Revenue | 13. Deferred Revenue | ||||||||
The following is a summary of changes in total deferred revenue for the years ended December 31, 2014 and 2013: | |||||||||
Year Ended December 31, | |||||||||
(in thousands) | 2014 | 2013 | |||||||
Balance beginning of period | $ | 90,275 | $ | 117,064 | |||||
Deferred Fanapt® product sales | 174 | — | |||||||
Licensing revenue recognized | 30,746 | 26,789 | |||||||
Recognized as part of gain on arbitration settlement | 59,529 | — | |||||||
Balance end of period | $ | 174 | $ | 90,275 | |||||
The Company entered into an amended and restated sublicense agreement with Novartis in 2009, pursuant to which Novartis had 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. The Company and Novartis established a Joint Steering Committee (JSC) following the effective date of the amended and restated sublicense agreement. The Company 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 had no term as the exact length of the JSC is undefined. As a result, the Company deemed the performance period of the JSC to be the life of the U.S. patent of Fanapt®. Revenue related to the upfront payment was recognized ratably from the date the amended and restated sublicense agreement became effective (November 2009) through the expected duration of the Novartis commercialization of Fanapt® in the U.S. which was estimated to be through the expiry of the Fanapt® composition of patent, including a granted Hatch-Waxman extension (November 2016). During the years ended December 31, 2014, 2013 and 2012, the Company recognized revenue of $30.7 million, $26.8 million and $26.8 million, respectively, related to the license agreement. | |||||||||
In connection with the Settlement Agreement with Novartis, the Company recognized the remaining deferred revenue balance of $59.5 million as part of the gain on arbitration settlement. See Note 3, Settlement Agreement with Novartis, for further discussion. |
Commitments_and_Contingencies
Commitments and Contingencies | 12 Months Ended | ||||||||||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||||||||||
Commitments and Contingencies | 14. Commitments and Contingencies | ||||||||||||||||||||||||||||
Operating leases | |||||||||||||||||||||||||||||
The following is a summary of the minimum annual future payments under operating leases as of December 31, 2014: | |||||||||||||||||||||||||||||
(in thousands) | Total | 2015 | 2016 | 2017 | 2018 | 2019 | Thereafter | ||||||||||||||||||||||
Operating leases | $ | 14,710 | $ | 1,395 | $ | 1,500 | $ | 1,538 | $ | 1,576 | $ | 1,616 | $ | 7,085 | |||||||||||||||
The minimum annual future payments for operating leases consists of the lease for office space for the Company’s headquarters located in Washington, D.C., which expires in 2023. | |||||||||||||||||||||||||||||
In 2011, the Company entered into an office 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, rent payments were abated for the first 12 months. The Landlord provided the Company with a cash contribution of $1.9 million for tenant improvements that was reflected in the consolidated financial statements as an increase to capitalized leasehold improvements and an increase to deferred rent for the year ended December 31, 2012. Subject to the prior rights of other tenants in the building, the Company has the right to renew the Lease for five years following the expiration of its original term. The Company has 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. | |||||||||||||||||||||||||||||
In March 2014, the Company and the Landlord entered into a lease amendment (the Lease Amendment). Under the Lease Amendment, the Company has the right to occupy an additional 8,860 square feet in the building. The Lease Amendment has a 12 year and one month term beginning on September 1, 2014, but may be terminated early by either the Landlord or the Company upon certain conditions. The Company will pay approximately $0.4 million in additional annual rent over the term of the Lease Amendment, however, rent will be abated for the first nine months. The Landlord will provide the Company with an allowance of approximately $0.8 million for construction on the premises to the Company’s specifications, subject to certain conditions. Subject to the prior rights of other tenants in the building, the Company will have the right to renew the Lease Amendment 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. | |||||||||||||||||||||||||||||
Rent expense under operating leases, was $1.7 million, $1.1 million and $2.0 million for the years ended December 31, 2014, 2013 and 2012, respectively. | |||||||||||||||||||||||||||||
Consulting fees | |||||||||||||||||||||||||||||
The Company engaged a regulatory consultant to assist the Company’s efforts to prepare, file and obtain FDA approval of an NDA for HETLIOZ®. As a result of the FDA approval of the NDA for HETLIOZ®, the Company made a milestone payment of $2.0 million in 2014. In 2013, as a result of the FDA acceptance of the NDA filing for HETLIOZ® for the treatment of Non-24, the Company made a milestone payment of $0.5 million to the regulatory consultant. These payments are included as research and development expense in the consolidated statements of operations for the years ended December 31, 2014 and 2013, respectively. In March 2014, the Company terminated the engagement. | |||||||||||||||||||||||||||||
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. Since inception, the Company has not incurred costs to defend lawsuits or settle claims related to these indemnification agreements. The Company also indemnifies its officers and directors for certain events or occurrences, subject to certain conditions. | |||||||||||||||||||||||||||||
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. | |||||||||||||||||||||||||||||
HETLIOZ®. In February 2004, the Company entered into a license agreement with Bristol-Myers Squibb Company (BMS) under which it received an exclusive worldwide license under certain patents and patent applications, and other licenses to intellectual property, to develop and commercialize HETLIOZ®. In partial consideration for the license, the Company paid BMS an initial license fee of $0.5 million. The Company made a milestone payment to BMS of $1.0 million under the license agreement in 2006 relating to the initiation of its first Phase III clinical trial for HETLIOZ®. As a result of the FDA acceptance of the Company’s NDA for HETLIOZ® for the treatment of Non-24 in July 2013, the Company incurred a $3.0 million milestone obligation under the license agreement with BMS. As a result of the FDA’s approval of the HETLIOZ® NDA in January 2014, the Company incurred an $8.0 million milestone obligation in the first quarter of 2014 under the same license agreement that was capitalized as an intangible asset and is being amortized over the expected HETLIOZ® patent life in the U.S. The Company is obligated to make a future milestone payment to BMS of $25.0 million in the event that cumulative worldwide sales of HETLIOZ® reach $250.0 million. Additionally, the Company is obligated to make royalty payments on HETLIOZ® net sales to BMS in any territory where it commercializes HETLIOZ® for a period equal to the greater of 10 years post the first commercial sale in the territory or the expiry of the new chemical entity patent in that territory. During the period prior to the expiry of the new chemical entity patent in a territory, the Company is obligated to pay a 10% royalty on net sales in that territory. The royalty rate is decreased by half for countries in which no new chemical entity patent existed or for the remainder of the 10 years after the expiry of the new chemical entity patent. The Company is also obligated under the license agreement to pay BMS a percentage of any sublicense fees, upfront payments and milestone and other payments (excluding royalties) that it 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 our license agreement for HETLIOZ® to use our commercially reasonable efforts to develop and commercialize HETLIOZ®. | |||||||||||||||||||||||||||||
The license agreement was amended in April 2013 to add a process that would allow BMS to waive the right to develop and commercialize HETLIOZ® in those countries not covered by a development and commercialization agreement. Subsequent to the execution of the April 2013 amendment, BMS provided the Company with formal written notice that it irrevocably waived the option to exercise the right to reacquire any or all rights to any product (as defined in the license agreement) containing HETLIOZ®, or to develop or commercialize any such product, in the countries not covered by a development and commercialization agreement. | |||||||||||||||||||||||||||||
Either party may terminate the HETLIOZ® license agreement under certain circumstances, including a material breach of the agreement by the other. In the event 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 the license agreement will revert or otherwise be licensed back to BMS on an exclusive basis. | |||||||||||||||||||||||||||||
Fanapt®. Pursuant to the terms of the Settlement Agreement with Novartis, Novartis transferred all U.S. and Canadian rights in the Fanapt® franchise to the Company on December 31, 2014. | |||||||||||||||||||||||||||||
A predecessor company of Sanofi, Hoechst Marion Roussel, Inc. (HMRI), discovered Fanapt® and completed early clinical work on the product. 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. As a result of the FDA’s approval of the NDA for Fanapt® in May 2009, the Company met a milestone under the sublicense agreement, which required it to make a payment of $12.0 million to Novartis. | |||||||||||||||||||||||||||||
In October 2009, the Company 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 was responsible for the further clinical development activities in the U.S. and Canada. Pursuant to the amended and restated sublicense agreement, the Company received an upfront payment of $200.0 million and was eligible for additional payments totaling up to $265.0 million upon Novartis’ achievement of certain commercial and development milestones for Fanapt® in the U.S. and Canada. The Company also received royalties, which, as a percentage of net sales, were in the low double-digits, on net sales of Fanapt® in the U.S. and Canada. The Company retained exclusive rights to Fanapt® outside the U.S. and Canada and is obligated to make royalty payments to Sanofi S.A. on Fanapt® sales outside the U.S. and Canada. | |||||||||||||||||||||||||||||
The Company has entered into agreements with the following partners for the commercialization of Fanapt® in the countries set forth below: | |||||||||||||||||||||||||||||
Country | Partner | Market Approval Date | |||||||||||||||||||||||||||
Mexico | Probiomed S.A. de C.V. | October 2013 | |||||||||||||||||||||||||||
Israel | Megapharm Ltd. | Aug-12 | |||||||||||||||||||||||||||
Pursuant to the terms of the Settlement Agreement with Novartis, Novartis transferred all U.S. and Canadian rights in the Fanapt® franchise to the Company on December 31, 2014. The Company is obligated to make royalty payments to Sanofi, S.A. and Titan, at a percentage rate equal to 23% on annual U.S. net sales of Fanapt® up to $200 million, and at a percentage in the mid-twenties on sales over $200 million through November 2016. After the expiration of the new chemical entity patent in major markets (US, United Kingdom, Germany, France, Italy, Spain and Japan) and some non-major markets, the Company will have a fixed royalty obligation to Sanofi on Fanapt® net sales of up to 9%. See Note 3, Settlement Agreement with Novartis, for further information. | |||||||||||||||||||||||||||||
Tradipitant. In April 2012, the Company entered into a license agreement with Eli Lilly and Company (Lilly) pursuant to which the Company acquired an exclusive worldwide license under certain patents and patent applications, and other licenses to intellectual property, to develop and commercialize an NK-1R antagonist, tradipitant, for all human indications. The patent describing tradipitant 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 license agreement, the Company paid Lilly an initial license fee of $1.0 million and will be responsible for all development costs. The initial license fee was recognized as research and development expense in the consolidated statement of operations for the year ended December 31, 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 is obligated to use its commercially reasonable efforts to develop and commercialize tradipitant. | |||||||||||||||||||||||||||||
Either party may terminate the license agreement under certain circumstances, including a material breach of the license agreement by the other. In the event that Vanda terminates the license agreement, or if Lilly terminates due to Vanda’s breach or for certain other reasons set forth in the license agreement, all rights licensed and developed by Vanda under the license agreement will revert or otherwise be licensed back to Lilly on an exclusive basis, subject to payment by Lilly to the Company of a royalty on net sales of products that contain tradipitant. | |||||||||||||||||||||||||||||
AQW051. In connection with the Settlement Agreement, the Company received an exclusive worldwide license under certain patents and patent applications, and other licenses to intellectual property, to develop and commercialize AQW051, a Phase II alpha-7 nicotinic acetylcholine receptor partial agonist. | |||||||||||||||||||||||||||||
Pursuant to the license agreement, the Company is obligated to use its commercially reasonable efforts to develop and commercialize AQW051 and is responsible for all development costs under the AQW051 license agreement. The Company has no milestone obligations; however, Novartis is eligible to receive tiered-royalties on net sales at percentage rates up to the mid-teens. | |||||||||||||||||||||||||||||
Future milestone payments. No amounts were recorded as liabilities nor were any future contractual obligations relating to the license agreements included in the consolidated financial statements as of December 31, 2014 because the criteria for recording the future milestone payments have not yet been met. These criteria include 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 at most 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. |
Income_Taxes
Income Taxes | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Income Taxes | 15. Income Taxes | ||||||||||||||||
As of December 31, 2014 and 2013, 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 NOLs could not be sufficiently assured. | |||||||||||||||||
The following is a summary of the Company’s current and deferred income tax provision (benefit) for years ended December 31, 2014, 2013 and 2012: | |||||||||||||||||
Year Ended December 31, | |||||||||||||||||
(in thousands) | 2014 | 2013 | 2012 | ||||||||||||||
Current income tax expense (benefit): | |||||||||||||||||
Federal | $ | — | $ | — | $ | — | |||||||||||
State | — | — | — | ||||||||||||||
Deferred income tax expense (benefit): | |||||||||||||||||
Federal | — | — | — | ||||||||||||||
State | — | — | — | ||||||||||||||
Total income tax expense (benefit) | $ | — | $ | — | $ | — | |||||||||||
The following is a reconciliation between the Company’s statutory tax rate and effective tax rate for the years ended December 31, 2014, 2013 and 2012: | |||||||||||||||||
Year Ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Federal tax at statutory rate | 34 | % | -34 | % | -34 | % | |||||||||||
State taxes | 7.2 | % | -4 | % | -3.3 | % | |||||||||||
Change in valuation allowance | -59.7 | % | 43.9 | % | 70.3 | % | |||||||||||
Research and development credit | 1.3 | % | -1.1 | % | 0.8 | % | |||||||||||
Orphan drug credit | 8.5 | % | -22.7 | % | -30.3 | % | |||||||||||
Stock options | 0 | % | 0 | % | 1.4 | % | |||||||||||
Section 162(m) limitation | 1.1 | % | 1.2 | % | 0 | % | |||||||||||
Stock issuance cost | 1.6 | % | 0 | % | 0 | % | |||||||||||
Tax rate change | 4.8 | % | -0.3 | % | -7 | % | |||||||||||
Change in Maryland NOL | 0 | % | 18.5 | % | 0 | % | |||||||||||
Other non-deductible items | 1.2 | % | -1.5 | % | 2.1 | % | |||||||||||
Effective tax rate | 0 | % | 0 | % | 0 | % | |||||||||||
The following is a summary of the components of the Company’s deferred tax assets, net, and the related valuation allowance as of December 31, 2014 and 2013: | |||||||||||||||||
December 31, | |||||||||||||||||
(in thousands) | 2014 | 2013 | |||||||||||||||
Deferred tax assets: | |||||||||||||||||
Net operating loss carry forwards | $ | 73,626 | $ | 48,206 | |||||||||||||
Stock-based compensation | 17,160 | 17,626 | |||||||||||||||
Deferred revenue | — | 36,670 | |||||||||||||||
Accrued and deferred expenses | 532 | 566 | |||||||||||||||
Research and development and orphan drug credit carryforwards | 36,772 | 38,597 | |||||||||||||||
Depreciation and amortization, net | 118 | 110 | |||||||||||||||
Contributions carryforward | 420 | — | |||||||||||||||
Reacquired rights | 182 | — | |||||||||||||||
Licensing agreements | 86 | — | |||||||||||||||
Total deferred tax assets | 128,896 | 141,775 | |||||||||||||||
Deferred tax liabilities: | |||||||||||||||||
Licensing agreements | — | (616 | ) | ||||||||||||||
Unrealized gain on available for sale securities | (6 | ) | (9 | ) | |||||||||||||
Total deferred tax liabilities | (6 | ) | (625 | ) | |||||||||||||
Deferred tax assets | 128,890 | 141,150 | |||||||||||||||
Valuation allowance | (128,890 | ) | (141,150 | ) | |||||||||||||
Net deferred tax assets | $ | — | $ | — | |||||||||||||
The fact that the Company has historically generated NOLs serves as strong evidence that it is more likely than not that deferred tax assets will not be realized in the future. Therefore, the Company has a full valuation allowance against all deferred tax assets as of December 31, 2014 and 2013. The net decrease in the tax valuation allowance was $12.3 million for the year ended December 31, 2014. The net increase in the tax valuation allowance was $7.9 million and $19.4 million for the years ended December 31, 2013 and 2012, respectively. | |||||||||||||||||
As of December 31, 2014, the Company had federal NOL carryforwards of $197.4 million, state NOL carryforwards of $201.3 million, which include $4.2 million of excess windfall benefits generated from stock options. The Company also has research and development credits of $6.2 million and orphan drug carryforward credits of $30.6 million. These NOL carryforwards and credits will begin to expire in 2028 and 2024, respectively. | |||||||||||||||||
Because the Company has generated NOLs from inception through December, 31, 2014, all income tax returns filed by the Company are open to examination by tax jurisdictions. As of December 31, 2014, the Company’s income tax returns have not been under examination by any federal or state tax jurisdictions. | |||||||||||||||||
The Company’s tax attributes, including NOLs and credits, are subject to any ownership changes as defined under IRC Section 382. A change in ownership could affect the Company’s ability to use its NOLs and credit carryforwards (tax attributes). Ownership changes did occur as of December 31, 2014 and December 31, 2008. However, the Company believes that it had sufficient Built-In-Gain to offset the IRC Section 382 limitation generated by the ownership changes. Any future ownership changes may cause the Company’s existing tax attributes to have additional limitations. Additionally, the Company maintains a valuation allowance on its tax attributes, therefore, any IRC Section 382 limitation would not have a material impact on the Company’s provision for income taxes as of December 31, 2014. | |||||||||||||||||
As of December 31, 2014 and 2013, the Company had no uncertain tax positions. | |||||||||||||||||
The valuation allowance activity on deferred tax assets was as follows: | |||||||||||||||||
(in thousands) | Balance At | Additions Charged | Reductions Credited | Balance At End | |||||||||||||
Beginning | To Income Tax | To Income Tax | Of Period | ||||||||||||||
Of Period | Expense | Expense | |||||||||||||||
Calendar year ended: | |||||||||||||||||
31-Dec-12 | $ | 113,823 | $ | 28,102 | $ | 8,654 | $ | 133,271 | |||||||||
31-Dec-13 | $ | 133,271 | $ | 22,998 | $ | 15,119 | $ | 141,150 | |||||||||
31-Dec-14 | $ | 141,150 | $ | 27,893 | $ | 40,153 | $ | 128,890 |
Fair_Value_Measurements
Fair Value Measurements | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Fair Value Measurements | 16. Fair Value Measurements | ||||||||||||||||
Authoritative 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 December 31, 2014 and 2013 are 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 certificates of deposit, commercial paper, corporate notes and U.S. government agency notes that use as their basis readily observable market parameters. | |||||||||||||||||
As of December 31, 2014, the Company held certain assets that are required to be measured at fair value on a recurring basis, as follows: | |||||||||||||||||
Fair Value Measurement as of December 31, 2014 Using | |||||||||||||||||
(in thousands) | December 31, | Quoted Prices in | Significant Other | Significant | |||||||||||||
2014 | Active Markets for | Observable Inputs | Unobservable | ||||||||||||||
Identical Assets | (Level 2) | Inputs | |||||||||||||||
(Level 1) | (Level 3) | ||||||||||||||||
Available-for-sale securities | $ | 68,921 | $ | 30,618 | $ | 38,303 | $ | — | |||||||||
As of December 31, 2013, the Company held certain assets that are required to be measured at fair value on a recurring basis, as follows: | |||||||||||||||||
Fair Value Measurement as of December 31, 2013 Using | |||||||||||||||||
(in thousands) | December 31, | Quoted Prices in | Significant Other | Significant | |||||||||||||
2013 | Active Markets for | Observable Inputs | Unobservable | ||||||||||||||
Identical Assets | (Level 2) | Inputs | |||||||||||||||
(Level 1) | (Level 3) | ||||||||||||||||
Available-for-sale securities | $ | 65,586 | $ | 31,566 | $ | 34,020 | $ | — | |||||||||
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, accounts payable and accrued liabilities, the carrying value of which materially approximate their fair values. During the years ended December 31, 2014 and 2013, there were no transfers between Level 1 and Level 2 of the fair value hierarchy. |
Restricted_Cash
Restricted Cash | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Restricted Cash | 17. Restricted Cash | ||||||||
The following is a summary of the Company’s restricted cash used to collateralize various letters of credit as of December 31, 2014 and 2013: | |||||||||
December 31, | |||||||||
(in thousands) | 2014 | 2013 | |||||||
Current: | |||||||||
Rockville, Maryland office lease | $ | — | $ | 430 | |||||
Maryland Board of Pharmacy license | — | 100 | |||||||
Total current | $ | — | $ | 530 | |||||
Non-current: | |||||||||
Washington, D.C. office lease | $ | 785 | $ | 500 | |||||
Maryland Board of Pharmacy license | — | — | |||||||
Total non-current | $ | 785 | $ | 500 | |||||
Public_Offering_of_Common_Stoc
Public Offering of Common Stock | 12 Months Ended |
Dec. 31, 2014 | |
Public Offering of Common Stock | 18. Public Offering of Common Stock |
In October 2014, the Company completed a public offering of 5,750,000 shares of common stock at a price to the public of $11.60 per share. Net cash proceeds from the public offering were $62.3 million, after deducting the underwriting discounts and commissions and offering expenses. In August 2013, the Company completed a public offering of 4,680,000 shares of common stock at a price to the public of $11.14 per share. Net cash proceeds from the 2013 public offering were $48.5 million, after deducting the underwriting discounts and commissions and offering expenses. |
Equity_Incentive_Plans
Equity Incentive Plans | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Equity Incentive Plans | 19. Equity Incentive Plans | ||||||||||||||||
As of December 31, 2014, 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 652,810 shares were subject to outstanding options granted under the 2004 Plan as of December 31, 2014, and no additional options will be granted under this plan. As of December 31, 2014, there were 10,329,472 shares of the Company’s common stock reserved for issuance under the 2006 Plan, of which 7,253,073 shares were subject to outstanding options and RSUs granted to employees and non-employees and 956,265 shares remained available for future grant. On January 1 of each year, the number of shares reserved under the 2006 Plan is automatically increased by the lesser of 4% of the total number of shares of common stock that are outstanding at that time or 1,500,000 shares (or such lesser number as may be approved by the Company’s board of directors). As of January 1, 2015, the number of shares of common stock that may be issued under the 2006 Plan was automatically increased by 1,500,000 shares, increasing the number of shares of common stock available for issuance under the Plan to 11,829,472 shares. | |||||||||||||||||
The Company has granted option awards with service conditions (service option awards) that are subject to terms and conditions established by the compensation committee of the board of directors. Service option awards have 10-year contractual terms and all service option awards granted prior to December 31, 2006, service option awards granted to new employees, and certain service option awards granted to existing employees vest and become exercisable on the first anniversary of the grant date with respect to the 25% of the shares subject to service option awards. The remaining 75% of the shares subject to the service option awards vest and become exercisable monthly in equal installments thereafter over three years. Certain service option awards granted to existing employees after December 31, 2006 vest and become exercisable monthly in equal installments over four years. The initial service option awards granted to directors upon their election vest and become exercisable in equal monthly installments over a period of four years, while the subsequent annual service option awards granted to directors vest and become exercisable in equal monthly installments over a period of one year. Certain service option awards to executives and directors provide for accelerated vesting if there is a change in control of the Company. Certain service 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 December 31, 2014, $14.0 million of unrecognized compensation costs related to unvested service option awards are expected to be recognized over a weighted average period of 1.7 years. No option awards are classified as a liability as of December 31, 2014. | |||||||||||||||||
The following is a summary of option activity for the 2004 Plan for the years ended December 31, 2014, 2013, and 2012: | |||||||||||||||||
(in thousands, except for share and per share amounts) | Number of | Weighted Average | Weighted Average | Aggregate | |||||||||||||
Shares | Exercise Price at | Remaining Term | Intrinsic | ||||||||||||||
Grant Date | (Years) | Value | |||||||||||||||
Outstanding at December 31, 2011 | 677,145 | $ | 1.78 | 3.78 | $ | 2,016 | |||||||||||
Exercised | (5,000 | ) | 0.33 | 14 | |||||||||||||
Outstanding at December 31, 2012 | 672,145 | 1.79 | 2.78 | 1,512 | |||||||||||||
Exercised | (115 | ) | 4.73 | ||||||||||||||
Expired | (1,286 | ) | 3.67 | ||||||||||||||
Outstanding at December 31, 2013 | 670,744 | 1.79 | 1.78 | 7,124 | |||||||||||||
Exercised | (17,934 | ) | 3.57 | ||||||||||||||
Outstanding at December 31, 2014 | 652,810 | 1.74 | 0.78 | 8,212 | |||||||||||||
Exercisable at December 31, 2014 | 652,810 | 1.74 | 0.78 | 8,212 | |||||||||||||
There are no options expected to vest as of December 31, 2014 under the 2004 Plan, given that the Company stopped issuing options from this plan in 2006. | |||||||||||||||||
The following is a summary of option activity for the 2006 Plan for the years ended December 31, 2014, 2013, and 2012: | |||||||||||||||||
(in thousands, except for share and per share amounts) | Number of | Weighted Average | Weighted Average | Aggregate | |||||||||||||
Shares | Exercise Price at | Remaining Term | Intrinsic | ||||||||||||||
Grant Date | (Years) | Value | |||||||||||||||
Outstanding at December 31, 2011 | 4,254,681 | $ | 12.16 | 7.65 | $ | 396 | |||||||||||
Granted | 846,000 | 3.42 | |||||||||||||||
Forfeited | (149,091 | ) | 7.5 | ||||||||||||||
Expired | (76,103 | ) | 10.68 | ||||||||||||||
Exercised | (10,000 | ) | 1.02 | 22 | |||||||||||||
Outstanding at December 31, 2012 | 4,865,487 | 10.83 | 7.15 | 634 | |||||||||||||
Granted | 1,245,500 | 10.18 | |||||||||||||||
Forfeited | (54,226 | ) | 6.14 | ||||||||||||||
Expired | (259,295 | ) | 10.65 | ||||||||||||||
Exercised | (263,848 | ) | 5.86 | 1,545 | |||||||||||||
Outstanding at December 31, 2013 | 5,533,618 | 10.98 | 6.93 | 21,264 | |||||||||||||
Granted | 1,324,337 | 12.17 | |||||||||||||||
Forfeited | (237,108 | ) | 8.35 | ||||||||||||||
Exercised | (393,735 | ) | 7.08 | 2,923 | |||||||||||||
Outstanding at December 31, 2014 | 6,227,112 | 11.58 | 6.71 | 28,523 | |||||||||||||
Exercisable at December 31, 2014 | 3,822,302 | 12.31 | 5.18 | 19,110 | |||||||||||||
Expected to vest at December 31, 2014 | 2,263,369 | 10.34 | 9.12 | 9,034 | |||||||||||||
Proceeds from the exercise of stock options amounted to $2.9 million, $1.6 million and $0.01 million for the years ended December 31, 2014, 2013 and 2012, respectively. | |||||||||||||||||
An 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. The Company has granted RSUs with service conditions (service RSUs) that vest in four equal annual installments provided that the employee remains employed with the Company. As of December 31, 2014, $8.3 million of unrecognized compensation costs related to unvested service RSUs are expected to be recognized over a weighted average period of 2.2 years. No service RSUs are classified as a liability as of December 31, 2014. | |||||||||||||||||
The following is a summary of RSU activity for the 2006 Plan for the years ended December 31, 2014, 2013, and 2012: | |||||||||||||||||
Number of | Weighted | ||||||||||||||||
Shares | Average | ||||||||||||||||
Underlying | Grant Date | ||||||||||||||||
RSUs | Fair Value | ||||||||||||||||
Unvested at December 31, 2011 | 522,346 | $ | 7.43 | ||||||||||||||
Granted | 245,000 | 3.28 | |||||||||||||||
Forfeited | (61,970 | ) | 7.64 | ||||||||||||||
Unvested at December 31, 2012 | 705,376 | 5.91 | |||||||||||||||
Granted | 400,500 | 10.29 | |||||||||||||||
Forfeited | (21,000 | ) | 6.41 | ||||||||||||||
Vested | (201,186 | ) | 6.71 | ||||||||||||||
Unvested at December 31, 2013 | 883,690 | 7.7 | |||||||||||||||
Granted | 436,115 | 12.28 | |||||||||||||||
Forfeited | (84,282 | ) | 6.75 | ||||||||||||||
Vested | (209,562 | ) | 6.67 | ||||||||||||||
Unvested at December 31, 2014 | 1,025,961 | 9.94 | |||||||||||||||
The grant date fair value for the 209,562 shares underlying RSUs that vested during the year ended December 31, 2014 was $1.4 million. In order for certain employees to satisfy the minimum statutory employee tax withholding requirements related to the issuance of common stock underlying certain of the RSUs that vested and settled during the year ended December 31, 2014, the Company withheld 32,386 shares of common stock and paid employee payroll withholding taxes of $0.4 million relating to the vesting and settlement of the RSUs. |
Employee_Benefit_Plan
Employee Benefit Plan | 12 Months Ended |
Dec. 31, 2014 | |
Employee Benefit Plan | 20. Employee Benefit Plan |
The Company has a defined contribution plan under the Internal Revenue Code Section 401(k). This plan covers substantially all employees who meet minimum age and service requirements and allows participants to defer a portion of their annual compensation on a pre-tax basis. Currently, the Company matches 50 percent up to the first six percent of employee contributions. All matching contributions have been paid by the Company. The Company match vests over a four year period. The total Company match was $0.2 million, $0.2 million and $0.1 million for the years ended December 31, 2014, 2013 and 2012, respectively. |
Legal_Matters
Legal Matters | 12 Months Ended |
Dec. 31, 2014 | |
Legal Matters | 21. Legal Matters |
In June 2014, the Company filed suit against Roxane Laboratories, Inc. (Roxane) in the U.S. District Court for the District of Delaware. The suit seeks an adjudication that Roxane has infringed one or more claims of the Company’s U.S. Patent No. 8,586,610 (the Patent) by submitting to the FDA an Abbreviated New Drug Application for generic versions of Fanapt® oral tablets in 1 mg, 2 mg, 4 mg, 6 mg, 8 mg, 10 mg, and 12 mg strengths. The relief requested by the Company includes a request for a permanent injunction preventing Roxane from infringing the asserted claims of the Patent by engaging in the manufacture, use, offer to sell, sale, importation or distribution of generic versions of Fanapt® before the expiration of the Patent in 2027. | |
Pursuant to the Settlement Agreement with Novartis, the Company assumed Novartis’ patent infringement action against Roxane in the U.S. District Court for the District of Delaware. The suit alleges that Roxane’s filing of an ANDA for generic iloperidone with a paragraph IV certification infringes Sanofi’s new chemical entity patent. Roxane is defending on the grounds that the patent claims are invalid or unenforceable or that certain patent claims are not infringed. Roxane also filed a motion to dismiss on the grounds that the court lacks jurisdiction. |
Quarterly_Financial_Data_unaud
Quarterly Financial Data (unaudited) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Quarterly Financial Data (unaudited) | 22. Quarterly Financial Data (unaudited) | ||||||||||||||||
(in thousands, except for per share amounts) | First | Second | Third | Fourth | |||||||||||||
Quarter | Quarter | Quarter | Quarter | ||||||||||||||
2014 | |||||||||||||||||
Revenue | $ | 9,143 | $ | 10,862 | $ | 14,782 | $ | 15,370 | |||||||||
Income (loss) from operations | (26,578 | ) | (21,606 | ) | (1,448 | ) | 69,693 | ||||||||||
Net income (loss) | (26,533 | ) | (21,575 | ) | (1,426 | ) | 69,719 | ||||||||||
Net income (loss) per share: | |||||||||||||||||
Basic | $ | (0.79 | ) | $ | (0.64 | ) | $ | (0.04 | ) | $ | 1.85 | ||||||
Diluted | $ | (0.79 | ) | $ | (0.64 | ) | $ | (0.04 | ) | $ | 1.77 | ||||||
2013 (1) | |||||||||||||||||
Revenue | $ | 8,068 | $ | 8,319 | $ | 8,709 | $ | 8,783 | |||||||||
Loss from operations | (4,565 | ) | (3,413 | ) | (5,431 | ) | (7,791 | ) | |||||||||
Net loss | (4,519 | ) | (3,383 | ) | (5,406 | ) | (7,747 | ) | |||||||||
Net loss per share, basic and diluted | $ | (0.16 | ) | $ | (0.12 | ) | $ | (0.17 | ) | $ | (0.23 | ) | |||||
The Company’s results for the fourth quarter of 2014 include a gain on arbitration settlement of $77.6 million, or $2.06 and $1.97 per basic and diluted share, respectively. See Note 3, Settlement Agreement with Novartis, for further discussion. | |||||||||||||||||
-1 | In the first quarter of 2014, the Company elected to change its method of accounting for stock-based compensation from the accelerated attribution method to the straight-line method. The consolidated financial data above for the year ended 2013 has been adjusted to reflect this change. See Note 4, Change in Method of Accounting for Stock-based Compensation, for further discussion. |
Business_Organization_and_Pres1
Business Organization and Presentation (Policies) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Business organization | 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 and the Company’s portfolio includes the following products. | |||||||||||||
• | HETLIOZ® (tasimelteon), a product for the treatment of Non-24-Hour Sleep-Wake Disorder (Non-24) for which a New Drug Application (NDA) was approved by the U.S. Food and Drug Administration (FDA) in January 2014 and launched commercially in the U.S. in April 2014. | ||||||||||||
• | Fanapt® (iloperidone), a product for the treatment of schizophrenia, the oral formulation of which was being marketed and sold in the U.S. by Novartis Pharma AG (Novartis) until December 31, 2014. On December 31, 2014, Novartis transferred all the U.S. and Canadian commercial rights to the Fanapt® franchise to the Company. See Note 3, Settlement Agreement with Novartis, for further information. Additionally, the Company’s distribution partners launched Fanapt® in Israel and Mexico in 2014. | ||||||||||||
• | Tradipitant (VLY-686), a small molecule neurokinin-1 receptor (NK-1R) antagonist, which is presently in clinical development for the treatment of chronic pruritus in atopic dermatitis. Results from a Phase II study for the treatment of chronic pruritus in atopic dermatitis were announced in March 2015. Clinical evaluation is ongoing to assess potential future development activities. | ||||||||||||
• | Trichostatin A, a small molecule histone deacetylase (HDAC) inhibitor. | ||||||||||||
• | AQW051, a Phase II alpha-7 nicotinic acetylcholine receptor partial agonist. | ||||||||||||
Basis of presentation | Basis of presentation | ||||||||||||
The accompanying consolidated financial statements have been prepared in accordance with accounting principles generally accepted in the United States of America. All intercompany accounts and transactions have been eliminated in consolidation. | |||||||||||||
Use of estimates | Use of estimates | ||||||||||||
The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America 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 | Cash and cash equivalents | ||||||||||||
For purposes of the consolidated balance sheets and 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 | 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 consolidated statements of operations when generated. Marketable securities with a maturity of more than one year as of the balance sheet date and 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. | |||||||||||||
Inventory | Inventory | ||||||||||||
Inventory, which is recorded at the lower of cost or market, includes the cost of third-party manufacturing and other direct and indirect costs and is valued using the first-in, first-out method. The Company capitalizes inventory costs associated with its products upon regulatory approval when, based on management’s judgment, future commercialization is considered probable and the future economic benefit is expected to be realized; otherwise, such costs are expensed as research and development. Inventory is evaluated for impairment by consideration of factors such as lower of cost or market, net realizable value, obsolescence or expiry. | |||||||||||||
Intangible asset | Intangible asset | ||||||||||||
Costs incurred for products not yet approved by the FDA and for which no alternative future use exists are recorded as expense. In the event a product has been approved by the FDA or an alternative future use exists for a product, patent and license costs are capitalized and amortized over the expected patent life of the related product. Milestone payments to the Company’s partners are recognized when it is deemed probable that the milestone event will occur. | |||||||||||||
Property and equipment | Property and equipment | ||||||||||||
Property and equipment are stated at cost less accumulated depreciation and amortization. The costs of leasehold improvements funded by or reimbursed by the lessor are capitalized and amortized as leasehold improvements along with a corresponding deferred rent liability. 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 statement of operations for that period. | |||||||||||||
Accrued liabilities | Accrued liabilities | ||||||||||||
The Company’s management is required to estimate accrued liabilities as part of the process of preparing financial statements. The estimation of accrued liabilities 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 liabilities 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: (i) an evaluation by the project manager of the work that has been completed during the period, (ii) measurement of progress prepared internally and/or provided by the third-party service provider, (iii) analyses of data that justify the progress, and (iv) 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. | |||||||||||||
Net Product Sales | Net Product Sales | ||||||||||||
The Company’s 2014 net product sales consist of U.S. sales of HETLIOZ® for the treatment of Non-24 and sales of Fanapt® in Israel. The Company applies the revenue recognition guidance in accordance with Financial Accounting Standards Board (FASB) Accounting Standards Codification (ASC) Subtopic 605-15, Revenue Recognition—Products. The Company recognizes revenue from product sales when there is persuasive evidence that an arrangement exists, title to product and associated risk of loss has passed to the customer, the price is fixed or determinable, collectability is reasonably assured and the Company has no further performance obligations. | |||||||||||||
In the U.S., HETLIOZ® is only available for distribution through a limited number of specialty pharmacies, and is not available in retail pharmacies. The Company invoices and records revenue when the specialty pharmacies receive HETLIOZ® from the third-party logistics warehouse. | |||||||||||||
The Company has entered into distribution agreements with Probiomed S.A. de C.V. (Probiomed) for the commercialization of Fanapt® in Mexico and Megapharm Ltd. for the commercialization of Fanapt® in Israel. With the exception of sales to Probiomed, the Company invoices and records revenue upon delivery of Fanapt® to the distribution partner. The Probiomed distribution agreement contains a contracted delivery price plus a revenue sharing provision based on Probiomed’s sales of Fanapt®. As a result, the selling price of Fanapt® is not fixed or determinable upon delivery of Fanapt® to Probiomed. The Company defers revenue recognition until the revenue sharing provision is calculated. As of December 31, 2014, the Company recorded $0.2 million of deferred revenue related to Fanapt® sales. | |||||||||||||
Product Sales Discounts and Allowances | |||||||||||||
HETLIOZ® product sales revenue is recorded net of applicable discounts, chargebacks, rebates, co-pay assistance, service fees and product returns that are applicable for various government and commercial payors. Reserves established for discounts and returns are classified as reductions of accounts receivable if the amount is payable to direct customers, with the exception of service fees. Service fees are classified as a liability. Reserves established for chargebacks, rebates or co-pay assistance are classified as a liability if the amount is payable to a party other than customers. The Company currently records sales allowances for the following: | |||||||||||||
Rebates: Allowances for rebates include mandated discounts under the Medicaid Drug Rebate Program. Rebate amounts owed after the final dispensing of the product to a benefit plan participant are based upon contractual agreements or legal requirements with public sector benefit providers, such as Medicaid. The allowance for rebates is based on statutory discount rates and expected utilization. Estimates for the expected utilization of rebates are based in part on actual and pending prescriptions for which the Company has validated the insurance benefits. Rebates are generally invoiced and paid in arrears, such that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarter’s unpaid rebates. | |||||||||||||
Chargebacks: Chargebacks are discounts that occur when contracted customers purchase directly from specialty pharmacies. Contracted customers, which currently consist primarily of Public Health Service institutions, non-profit clinics, and Federal government entities purchasing via the Federal Supply Schedule, generally purchase the product at a discounted price. The specialty pharmacy, in turn, charges back the difference between the price initially paid by the specialty pharmacy and the discounted price paid to the specialty pharmacy by the contracted customer. The allowance for chargebacks is based on actual and pending prescriptions for which the Company has validated the insurance benefits. | |||||||||||||
Medicare Part D Coverage Gap: Medicare Part D prescription drug benefit mandates manufacturers to fund approximately 50% of the Medicare Part D insurance coverage gap for prescription drugs sold to eligible patients. Estimates for expected Medicare Part D coverage gap are based in part on historical invoices received and on actual and pending prescriptions for which the Company has validated the insurance benefits. Funding of the coverage gap is generally invoiced and paid in arrears so that the accrual balance consists of an estimate of the amount expected to be incurred for the current quarter’s activity, plus an accrual balance for known prior quarter activity. If actual future funding varies from estimates, the Company may need to adjust accruals, which would affect net revenue in the period of adjustment. | |||||||||||||
Service Fees: The Company also incurs specialty pharmacy fees for services and their data. These fees are based on contracted terms and are known amounts. The Company accrues service fees at the time of revenue recognition, resulting in a reduction of product sales revenue and the recognition of an accrued liability, unless it receives an identifiable and separate benefit for the consideration and it can reasonably estimate the fair value of the benefit received. In which case, service fees are recorded as selling, general and administrative expense. | |||||||||||||
Co-payment Assistance: Patients who have commercial insurance and meet certain eligibility requirements may receive co-payment assistance. Co-pay assistance utilization is based on information provided by the Company’s third-party administrator. The allowance for co-pay assistance is based on actual and pending sales for which the Company has validated the insurance benefits. | |||||||||||||
Prompt-pay: Specialty pharmacies are offered discounts for prompt payment. The Company expects that the specialty pharmacy will earn prompt payment discounts and, therefore, deducts the full amount of these discounts from total product sales when revenues are recognized. | |||||||||||||
Product Returns: Consistent with industry practice, the Company generally offers direct customers a limited right to return as defined within the Company’s returns policy. The Company considers several factors in the estimation process, including expiration dates of product shipped to specialty pharmacies, inventory levels within the distribution channel, product shelf life, prescription trends and other relevant factors. | |||||||||||||
There were no discounts or rebates associated with Fanapt® product sales recognized in the period. The Company’s partners have a limited right to return Fanapt®. Once Fanapt® has been delivered to the partners it generally may not be returned for any reason other than product recall. | |||||||||||||
License Revenue | |||||||||||||
The Company’s license revenues were derived from the amended and restated sublicense agreement with Novartis and include an upfront payment and future milestone and royalty payments. Pursuant to the amended and restated sublicense agreement, Novartis had 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. Revenue related to the upfront payment was recognized ratably from the date the amended and restated sublicense agreement became effective (November 2009) through the expected duration of the Novartis commercialization of Fanapt® in the U.S. which was estimated to be through the expiry of the Fanapt® composition of patent, including a granted Hatch-Waxman extension (November 2016). In connection with the Settlement Agreement with Novartis, the Company recognized the remaining deferred revenue as of December 31, 2014 as part of the gain on arbitration settlement. See Note 3, Settlement Agreement with Novartis, for further discussion. | |||||||||||||
Cost of goods sold | Cost of goods sold | ||||||||||||
Cost of goods sold includes royalties payable, the cost of inventory sold, manufacturing and supply chain costs and product shipping and handling costs related to U.S. sales of HETLIOZ® and sales of Fanapt® to the Company’s distribution partners. | |||||||||||||
Research and development expenses | Research and development expenses | ||||||||||||
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 payments, 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 research and development personnel. The Company expenses research and development costs as they are incurred for products in the development stage, including manufacturing costs and milestone payments made under license agreements prior to FDA approval. Upon and subsequent to FDA approval, manufacturing and milestone payments related to license agreements are capitalized. Milestone payments are accrued when it is deemed probable that the milestone event will be achieved. Costs related to the acquisition of intellectual property are expensed as incurred if the underlying technology is developed in connection with the Company’s research and development efforts and has no alternative future use. | |||||||||||||
Selling general and administrative expenses | Selling, general and administrative expenses | ||||||||||||
Selling, general and administrative expenses consist of salaries, including employee stock-based compensation, facilities and third party expenses. Selling, general and administrative expenses are associated with the activities of the executive, finance, accounting, information technology, business development, commercial support, trade and distribution, sales, marketing, legal, medical affairs and human resource functions. | |||||||||||||
Employee stock-based compensation | Employee stock-based compensation | ||||||||||||
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. | |||||||||||||
In January 2014, the Company elected to change its method of accounting for the attribution of compensation cost for stock options with graded-vesting and only service conditions to the straight-line method. Previously, attribution was based on the accelerated attribution method, which treated each vesting tranche as an individual award and amortized them concurrently. See Note 4, Change in Method of Accounting for Stock-based Compensation, for further information. The fair value of restricted stock units (RSUs) awarded is also amortized using the straight line method. Stock-based compensation expense recognized in the consolidated statements of operations is based on awards ultimately expected to vest. Therefore, 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. | |||||||||||||
Total employee stock-based compensation expense recognized for the years ended December 31, 2014, 2013 and 2012 was comprised of the following: | |||||||||||||
Year Ended December 31, | |||||||||||||
(in thousands) | 2014 | 2013 | 2012 | ||||||||||
Research and development | $ | 1,810 | $ | 2,098 | $ | 1,673 | |||||||
Selling, general and administrative | 3,945 | 3,238 | 3,353 | ||||||||||
$ | 5,755 | $ | 5,336 | $ | 5,026 | ||||||||
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. Expected volatility rates are based on the historical volatility of the Company’s publicly traded common stock and other factors. Beginning in 2014, the Company started using a mid-point scenario to calculate the weighted average expected term of stock options granted, which combines the Company’s historical exercise data with hypothetical exercise data for unexercised stock options. Prior to 2014, the expected term assumption was determined using the simplified 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. The Company has not paid dividends to its stockholders since its inception (other than a dividend of preferred share purchase rights, which was declared in September 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 years ended December 31, 2014, 2013 and 2012 were as follows: | |||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Expected dividend yield | 0 | % | 0 | % | 0 | % | |||||||
Weighted average expected volatility | 62 | % | 65 | % | 68 | % | |||||||
Weighted average expected term (years) | 5.9 | 6.03 | 6.03 | ||||||||||
Weighted average risk-free rate | 1.73 | % | 1.59 | % | 0.94 | % | |||||||
Weighted average fair value per share | $ | 6.99 | $ | 6.1 | $ | 2.08 | |||||||
Advertising Expense | Advertising Expense | ||||||||||||
The Company expenses the costs of advertising, including branded promotional expenses, as incurred. Branded advertising expenses, recorded in selling, general and administrative expenses, were $5.0 million for the year ended December 31, 2014. The Company did not incur any advertising expense during the years ended December 31, 2013 and 2012. | |||||||||||||
Income taxes | Income taxes | ||||||||||||
The Company accounts for income taxes in accordance with the authoritative guidance 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. The fact that the Company has historically generated net operating losses (NOLs) serves as strong evidence that it is more likely than not that deferred tax assets will not be realized in the future. Therefore, the Company has a full valuation allowance against all deferred tax assets as of December 31, 2014 and 2013, respectively. Tax rate changes are reflected in income during the period such changes are enacted. Changes in ownership may limit the amount of NOL carryforwards that can be utilized in the future to offset taxable income. | |||||||||||||
Certain risks and uncertainties | Certain risks and uncertainties | ||||||||||||
The Company’s products under development require approval from the FDA or other international regulatory agencies prior to commercial sales. There can be no assurance the products will receive the necessary clearance. If the Company is denied clearance or clearance is delayed, it may have a material adverse impact on the Company. | |||||||||||||
The Company’s products are concentrated in rapidly-changing, highly-competitive markets, which are characterized by rapid technological advances, changes in customer requirements and evolving regulatory requirements and industry standards. Any failure by the Company to anticipate or to respond adequately to technological developments in its industry, changes in customer requirements or changes in regulatory requirements or industry standards or any significant delays in the development or introduction of products or services could have a material adverse effect on the Company’s business, operating results and future cash flows. | |||||||||||||
The Company depends on single source suppliers for critical raw materials for manufacturing, as well as other components required for the administration of its products. The loss of these suppliers could delay the clinical trials or prevent or delay commercialization of the products. | |||||||||||||
Concentrations of credit risk | 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 highly-rated financial institutions. At December 31, 2014, 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. | |||||||||||||
Segment information | Segment information | ||||||||||||
The Company’s management has determined that the Company operates in one business segment which is the development and commercialization of pharmaceutical products. | |||||||||||||
Recent accounting pronouncements | Recent accounting pronouncements | ||||||||||||
In January 2015, the FASB issued Accounting Standards Update (ASU) 2015-01, Income Statement-Extraordinary and Unusual Items, to simplify income statement classification by removing the concept of extraordinary items from U.S. GAAP. As a result, items that are both unusual and infrequent will no longer be separately reported net of tax after continuing operations. The new standard is effective for both public and private companies for periods beginning after December 15, 2015. Adoption of this new standard is not expected to have a material impact on the Company’s condensed consolidated financial statements. | |||||||||||||
In August 2014, the FASB issued ASU 2014-15, Presentation of Financial Statements—Going Concern. The new standard requires management of public and private companies to evaluate whether there is substantial doubt about the entity’s ability to continue as a going concern and, if so, disclose that fact. Management will also be required to evaluate and disclose whether its plans alleviate that doubt. The new standard is effective for annual periods ending after December 15, 2016, and interim periods within annual periods beginning after December 15, 2016. Adoption of this new standard is not expected to have a material impact on the Company’s condensed consolidated financial statements. | |||||||||||||
In May 2014, the FASB issued ASU 2014-09, Revenue from Contracts with Customers (Topic 606). This new standards requires companies to recognize revenue when it transfers promised goods or services to customers in an amount that reflects the consideration to which a company expects to be entitled in exchange for those goods or services. Under the new standard, revenue is recognized when a customer obtains control of a good or service. The standard allows for two transition methods—entities can either apply the new standard (i) retrospectively to each prior reporting period presented, or (ii) retrospectively with the cumulative effect of initially applying the standard recognized at the date of initial adoption. The new standard is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2016. Early adoption of the standard is prohibited. The Company is evaluating this standard to determine if adoption will have a material impact on the Company’s condensed consolidated financial statements. | |||||||||||||
In July 2013, the FASB issued ASU 2013-11, Income Taxes (Topic 740): Presentation of an Unrecognized Tax Benefit When a Net Operating Loss Carryforward, a Similar Tax Loss, or a Tax Credit Carryforward Exists. This new standard requires the netting of unrecognized tax benefits against a deferred tax asset for a loss or other carryforward that would apply in settlement of the uncertain tax positions. Under the new standard, unrecognized tax benefits will be netted against all available same-jurisdiction loss or other tax carryforwards that would be utilized, rather than only against carryforwards that are created by the unrecognized tax benefits. The new standard is effective for public companies for fiscal years, and interim periods within those fiscal years, beginning after December 15, 2013. Adoption of this new standard did not have a material impact on the Company’s condensed consolidated financial statements. |
Summary_of_Significant_Account1
Summary of Significant Accounting Policies (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Total Employee Stock-Based Compensation Expense | Total employee stock-based compensation expense recognized for the years ended December 31, 2014, 2013 and 2012 was comprised of the following: | ||||||||||||
Year Ended December 31, | |||||||||||||
(in thousands) | 2014 | 2013 | 2012 | ||||||||||
Research and development | $ | 1,810 | $ | 2,098 | $ | 1,673 | |||||||
Selling, general and administrative | 3,945 | 3,238 | 3,353 | ||||||||||
$ | 5,755 | $ | 5,336 | $ | 5,026 | ||||||||
Black-Scholes-Merton Option Pricing Model for Employee and Director Stock Options Granted | Assumptions used in the Black-Scholes-Merton option pricing model for employee and director stock options granted during the years ended December 31, 2014, 2013 and 2012 were as follows: | ||||||||||||
Year Ended December 31, | |||||||||||||
2014 | 2013 | 2012 | |||||||||||
Expected dividend yield | 0 | % | 0 | % | 0 | % | |||||||
Weighted average expected volatility | 62 | % | 65 | % | 68 | % | |||||||
Weighted average expected term (years) | 5.9 | 6.03 | 6.03 | ||||||||||
Weighted average risk-free rate | 1.73 | % | 1.59 | % | 0.94 | % | |||||||
Weighted average fair value per share | $ | 6.99 | $ | 6.1 | $ | 2.08 |
Settlement_Agreement_with_Nova1
Settlement Agreement with Novartis (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Fair Value of Consideration Exchanged as Part of Settlement Agreement | The following summarizes the fair value of consideration exchanged as part of the Settlement Agreement: | ||||||||
(in thousands) | |||||||||
Equity issued | $ | 25,904 | |||||||
Cash received | (25,000 | ) | |||||||
Settlement of pre-existing non-contractual relationship | 18,087 | ||||||||
$ | 18,991 | ||||||||
Assets Acquired and Recorded at Fair Value | Assets acquired and recorded at fair value as of December 31, 2014 were as follows: | ||||||||
(in thousands) | |||||||||
Inventory | $ | 2,960 | |||||||
Intangible—Re-acquired right | 15,940 | ||||||||
Prepaid services | 91 | ||||||||
$ | 18,991 | ||||||||
Supplemental Pro Forma Information for Combined Results of Operations of Company and FanaptB. Business | Future results may vary significantly from the results in this pro forma information because of future unknown events. | ||||||||
Year Ended December 31, | |||||||||
(in thousands, except per share amounts) | 2014 | 2013 | |||||||
Revenue | $ | 79,335 | $ | 75,270 | |||||
Net income (loss) | $ | (100,742 | ) | $ | 41,048 | ||||
Basic income (loss) per share | $ | (2.90 | ) | $ | 1.35 | ||||
Diluted income (loss) per share | $ | (2.90 | ) | $ | 1.29 |
Change_in_Method_of_Accounting1
Change in Method of Accounting for Stock-based Compensation (Tables) | 12 Months Ended | ||||||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||||||
Adjustments in Balance Sheet | The adjustments as of December 31, 2011 were as follows: | ||||||||||||||||||||||||
Balance Sheet | |||||||||||||||||||||||||
December 31, 2011 | |||||||||||||||||||||||||
(in thousands, except for share and per share amounts) | As Previously | Retrospective | As | ||||||||||||||||||||||
Reported | Adjustment | Adjusted | |||||||||||||||||||||||
Stockholders’ equity: | |||||||||||||||||||||||||
Preferred stock, $0.001 par value; 20,000,000 shares authorized, and no shares issued or outstanding | — | — | |||||||||||||||||||||||
Common stock, $0.001 par value; 150,000,000 shares authorized; 28,117,026 shares issued and outstanding at December 31, 2011 | $ | 28 | $ | — | $ | 28 | |||||||||||||||||||
Additional paid-in capital | 296,868 | (4,945 | ) | 291,923 | |||||||||||||||||||||
Accumulated other comprehensive income | 21 | — | 21 | ||||||||||||||||||||||
Accumulated deficit | (263,443 | ) | 4,945 | (258,498 | ) | ||||||||||||||||||||
Total stockholders’ equity | $ | 33,474 | $ | — | $ | 33,474 | |||||||||||||||||||
Adjustments in Statement of Operations | The adjustments for the years ended December 31, 2013 and 2012 were as follows: | ||||||||||||||||||||||||
Statement of Operations | |||||||||||||||||||||||||
(in thousands, except for share and | Year Ended December 31, 2013 | Year Ended December 31, 2012 | |||||||||||||||||||||||
per share amounts) | As previously | Retrospective | As | As previously | Retrospective | As | |||||||||||||||||||
Reported | Adjustment | Adjusted | Reported | Adjustment | Adjusted | ||||||||||||||||||||
Revenues: | |||||||||||||||||||||||||
Licensing agreement | $ | 26,789 | $ | — | $ | 26,789 | $ | 26,789 | $ | — | $ | 26,789 | |||||||||||||
Royalty revenue | 7,090 | — | 7,090 | 5,938 | — | 5,938 | |||||||||||||||||||
Total revenues | 33,879 | — | 33,879 | 32,727 | — | 32,727 | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||||
Cost of goods sold | — | — | — | 129 | — | 129 | |||||||||||||||||||
Research and development | 28,190 | 312 | 28,502 | 45,446 | 318 | 45,764 | |||||||||||||||||||
Selling, general and administrative | 24,594 | 488 | 25,082 | 13,882 | 635 | 14,517 | |||||||||||||||||||
Intangible asset amortization | 1,495 | — | 1,495 | 1,495 | — | 1,495 | |||||||||||||||||||
Total operating expenses | 54,279 | 800 | 55,079 | 60,952 | 953 | 61,905 | |||||||||||||||||||
Loss from operations | (20,400 | ) | (800 | ) | (21,200 | ) | (28,225 | ) | (953 | ) | (29,178 | ) | |||||||||||||
Other income | 145 | — | 145 | 561 | — | 561 | |||||||||||||||||||
Loss before tax benefit | (20,255 | ) | (800 | ) | (21,055 | ) | (27,664 | ) | (953 | ) | (28,617 | ) | |||||||||||||
Tax benefit | — | — | — | — | — | — | |||||||||||||||||||
Net loss | $ | (20,255 | ) | $ | (800 | ) | $ | (21,055 | ) | $ | (27,664 | ) | $ | (953 | ) | $ | (28,617 | ) | |||||||
Basic and diluted net loss per share | $ | (0.67 | ) | $ | (0.02 | ) | $ | (0.69 | ) | $ | (0.98 | ) | $ | (0.03 | ) | $ | (1.01 | ) | |||||||
Weighted average shares outstanding, basic and diluted | 30,351,353 | — | 30,351,353 | 28,228,409 | — | 28,228,409 | |||||||||||||||||||
Adjustments in Statement of Comprehensive Loss | The adjustments for the years ended December 31, 2013 and 2012 were as follows: | ||||||||||||||||||||||||
Statement of Comprehensive Loss | |||||||||||||||||||||||||
Year Ended December 31, 2013 | Year Ended December 31, 2012 | ||||||||||||||||||||||||
(in thousands) | As Previously | Retrospective | As | As Previously | Retrospective | As | |||||||||||||||||||
Reported | Adjustment | Adjusted | Reported | Adjustment | Adjusted | ||||||||||||||||||||
Net loss | $ | (20,255 | ) | $ | (800 | ) | $ | (21,055 | ) | $ | (27,664 | ) | $ | (953 | ) | $ | (28,617 | ) | |||||||
Other comprehensive income (loss): | |||||||||||||||||||||||||
Change in net unrealized loss on marketable securities | 11 | — | 11 | (11 | ) | — | (11 | ) | |||||||||||||||||
Tax provision on other comprehensive income (loss) | — | — | — | — | — | — | |||||||||||||||||||
Other comprehensive income (loss), net of tax: | 11 | — | 11 | (11 | ) | — | (11 | ) | |||||||||||||||||
Comprehensive loss | $ | (20,244 | ) | $ | (800 | ) | $ | (21,044 | ) | $ | (27,675 | ) | $ | (953 | ) | $ | (28,628 | ) | |||||||
Adjustments in Statement of Cash Flows | The adjustments for the years ended December 31, 2013 and 2012 were as follows: | ||||||||||||||||||||||||
Statement of Cash Flows | |||||||||||||||||||||||||
Year Ended December 31, 2013 | Year Ended December 31, 2012 | ||||||||||||||||||||||||
(in thousands) | As Previously | Retrospective | As | As Previously | Retrospective | As | |||||||||||||||||||
Reported | Adjustment | Adjusted | Reported | Adjustment | Adjusted | ||||||||||||||||||||
Cash flows from operating activities | |||||||||||||||||||||||||
Net loss | $ | (20,255 | ) | $ | (800 | ) | $ | (21,055 | ) | $ | (27,664 | ) | $ | (953 | ) | $ | (28,617 | ) | |||||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||||||||||||||||
Depreciation and amortization of property and equipment | 432 | — | 432 | 633 | — | 633 | |||||||||||||||||||
Employee and non-employee stock-based compensation | 4,604 | 800 | 5,404 | 4,094 | 953 | 5,047 | |||||||||||||||||||
Amortization of discounts and premiums on marketable securities | 155 | — | 155 | 560 | — | 560 | |||||||||||||||||||
Intangible asset amortization | 1,495 | — | 1,495 | 1,495 | — | 1,495 | |||||||||||||||||||
Landlord contributions for tenant improvements | — | — | — | 1,826 | — | 1,826 | |||||||||||||||||||
Changes in assets and liabilities, net | (26,023 | ) | — | (26,023 | ) | (25,861 | ) | — | (25,861 | ) | |||||||||||||||
Net cash used in operating activities | $ | (39,592 | ) | $ | — | $ | (39,592 | ) | $ | (44,917 | ) | $ | — | $ | (44,917 | ) | |||||||||
Earnings_per_Share_Tables
Earnings per Share (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Basic and Diluted Net Income (Loss) Per Share of Common Stock | The following table presents the calculation of basic and diluted net income (loss) per share of common stock for the years ended December 31, 2014, 2013, and 2012: | ||||||||||||
Year Ended December 31, | |||||||||||||
(in thousands, except for share and per share amounts) | 2014 | 2013 | 2012 | ||||||||||
Numerator: | |||||||||||||
Net income (loss) | $ | 20,186 | $ | (21,055 | ) | $ | (28,617 | ) | |||||
Denominator: | |||||||||||||
Weighted average shares outstanding: Basic | 34,774,163 | 30,351,353 | 28,228,409 | ||||||||||
Effect of dilutive securities | 1,912,560 | — | — | ||||||||||
Weighted average shares outstanding: Diluted | 36,686,723 | 30,351,353 | 28,228,409 | ||||||||||
Net income (loss) per share, basic and diluted: | |||||||||||||
Basic | $ | 0.58 | $ | (0.69 | ) | $ | (1.01 | ) | |||||
Diluted | $ | 0.55 | $ | (0.69 | ) | $ | (1.01 | ) | |||||
Antidilutive securities excluded from calculations of diluted net income (loss) per share | 3,524,656 | 4,409,811 | 5,462,476 | ||||||||||
Marketable_Securities_Tables
Marketable Securities (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Summary of Available-for-Sale Marketable Securities | The following is a summary of the Company’s available-for-sale marketable securities as of December 31, 2014, which all have contract maturities of less than one year: | ||||||||||||||||
(in thousands) | Amortized | Gross | Gross | Fair | |||||||||||||
Cost | Unrealized | Unrealized | Market | ||||||||||||||
Gains | Losses | Value | |||||||||||||||
U.S. Treasury and government agencies | $ | 30,618 | $ | 4 | $ | (4 | ) | $ | 30,618 | ||||||||
Corporate debt | $ | 38,287 | $ | 25 | $ | (9 | ) | $ | 38,303 | ||||||||
$ | 68,905 | $ | 29 | $ | (13 | ) | $ | 68,921 | |||||||||
The following is a summary of the Company’s available-for-sale marketable securities as of December 31, 2013: | |||||||||||||||||
(in thousands) | Amortized | Gross | Gross | Fair | |||||||||||||
Cost | Unrealized | Unrealized | Market | ||||||||||||||
Gains | Losses | Value | |||||||||||||||
U.S. Treasury and government agencies | $ | 31,557 | $ | 9 | $ | — | $ | 31,566 | |||||||||
Corporate debt | $ | 34,008 | $ | 18 | $ | (6 | ) | $ | 34,020 | ||||||||
$ | 65,565 | $ | 27 | $ | (6 | ) | $ | 65,586 | |||||||||
Inventory_Tables
Inventory (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Inventory | Inventory consisted of the following as of December 31, 2014 and December 31, 2013: | ||||||||
December 31, | |||||||||
(in thousands) | 2014 | 2013 | |||||||
Raw materials | $ | 198 | $ | — | |||||
Work-in-process | 1,326 | — | |||||||
Finished goods | 3,394 | — | |||||||
Deferred cost of goods sold | 252 | — | |||||||
Total | $ | 5,170 | $ | — | |||||
Prepaid_Expenses_and_Other_Cur1
Prepaid Expenses and Other Current Assets (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Summary of Prepaid Expenses, and Other Current Assets | The following is a summary of the Company’s prepaid expenses and other current assets as of December 31, 2014 and 2013: | ||||||||
December 31, | |||||||||
(in thousands) | 2014 | 2013 | |||||||
Prepaid insurance | $ | 270 | $ | 167 | |||||
Prepaid manufacturing cost | 358 | — | |||||||
Other prepaid expenses and vendor advances | 2,302 | 2,408 | |||||||
Other current assets | 154 | 128 | |||||||
Total prepaid expenses and other current assets | $ | 3,084 | $ | 2,703 | |||||
Property_and_Equipment_Tables
Property and Equipment (Tables) | 12 Months Ended | ||||||||||||
Dec. 31, 2014 | |||||||||||||
Summary of Property and Equipment-at Cost | The following is a summary of the Company’s property and equipment-at cost, as of December 31, 2014 and 2013: | ||||||||||||
Estimated | December 31, | ||||||||||||
Useful Life | |||||||||||||
(in thousands) | (Years) | 2014 | 2013 | ||||||||||
Computer equipment | 3 | $ | 1,316 | $ | 983 | ||||||||
Furniture and fixtures | 7 | 765 | 580 | ||||||||||
Leasehold improvements | 11 | 2,089 | 1,884 | ||||||||||
$ | 4,170 | $ | 3,447 | ||||||||||
Accumulated depreciation and amortization | $ | (1,733 | ) | $ | (1,249 | ) | |||||||
$ | 2,437 | $ | 2,198 | ||||||||||
Intangible_Assets_Tables
Intangible Assets (Tables) | 12 Months Ended | ||||||||||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||||||||||
Summary of Intangible Asset | The following is a summary of the Company’s intangible assets as of December 31, 2014 and 2013: | ||||||||||||||||||||||||||||
Estimated Useful | December 31, 2014 | ||||||||||||||||||||||||||||
(in thousands) | Life | Gross Carrying | Accumulated | Net Carrying | |||||||||||||||||||||||||
Amount | Amortization | Amount | |||||||||||||||||||||||||||
HETLIOZ® | January 2033 | $ | 8,000 | $ | 539 | $ | 7,461 | ||||||||||||||||||||||
Fanapt® | November 2016 | $ | 27,941 | $ | 8,678 | $ | 19,263 | ||||||||||||||||||||||
Estimated | 31-Dec-13 | ||||||||||||||||||||||||||||
(in thousands) | Useful Life | Gross Carrying | Accumulated | Net Carrying | |||||||||||||||||||||||||
Amount | Amortization | Amount | |||||||||||||||||||||||||||
Fanapt® | Nov-16 | $ | 12,000 | $ | 6,963 | $ | 5,037 | ||||||||||||||||||||||
Summary of Future Intangible Asset Amortization | The following is a summary of the future intangible asset amortization schedule as of December 31, 2014: | ||||||||||||||||||||||||||||
(in thousands) | Total | 2015 | 2016 | 2017 | 2018 | 2019 | Thereafter | ||||||||||||||||||||||
HETLIOZ® | $ | 7,461 | $ | 411 | $ | 411 | $ | 411 | $ | 411 | $ | 411 | $ | 5,406 | |||||||||||||||
Fanapt® | 19,263 | 10,050 | 9,213 | — | — | — | — | ||||||||||||||||||||||
$ | 26,724 | $ | 10,461 | $ | 9,624 | $ | 411 | $ | 411 | $ | 411 | $ | 5,406 | ||||||||||||||||
Accrued_Liabilities_Tables
Accrued Liabilities (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Summary of Accrued Liabilities | The following is a summary of the Company’s accrued liabilities as of December 31, 2014 and 2013: | ||||||||
December 31, | |||||||||
(in thousands) | 2014 | 2013 | |||||||
Accrued research and development expenses | $ | 1,759 | $ | 2,324 | |||||
Accrued consulting and other professional fees | 2,522 | 2,015 | |||||||
Compensation and employee benefits | 388 | 176 | |||||||
Other accrued liabilities | 1,833 | 665 | |||||||
$ | 6,502 | $ | 5,180 | ||||||
Deferred_Revenue_Tables
Deferred Revenue (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Summary of Changes in Total Deferred Revenue | The following is a summary of changes in total deferred revenue for the years ended December 31, 2014 and 2013: | ||||||||
Year Ended December 31, | |||||||||
(in thousands) | 2014 | 2013 | |||||||
Balance beginning of period | $ | 90,275 | $ | 117,064 | |||||
Deferred Fanapt® product sales | 174 | — | |||||||
Licensing revenue recognized | 30,746 | 26,789 | |||||||
Recognized as part of gain on arbitration settlement | 59,529 | — | |||||||
Balance end of period | $ | 174 | $ | 90,275 | |||||
Commitments_and_Contingencies_
Commitments and Contingencies (Tables) | 12 Months Ended | ||||||||||||||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||||||||||||||
Summary of Minimum Annual Future Payments under Operating Leases | The following is a summary of the minimum annual future payments under operating leases as of December 31, 2014: | ||||||||||||||||||||||||||||
(in thousands) | Total | 2015 | 2016 | 2017 | 2018 | 2019 | Thereafter | ||||||||||||||||||||||
Operating leases | $ | 14,710 | $ | 1,395 | $ | 1,500 | $ | 1,538 | $ | 1,576 | $ | 1,616 | $ | 7,085 |
Income_Taxes_Tables
Income Taxes (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Summary of Current and Deferred Income Tax Provision (Benefit) | The following is a summary of the Company’s current and deferred income tax provision (benefit) for years ended December 31, 2014, 2013 and 2012: | ||||||||||||||||
Year Ended December 31, | |||||||||||||||||
(in thousands) | 2014 | 2013 | 2012 | ||||||||||||||
Current income tax expense (benefit): | |||||||||||||||||
Federal | $ | — | $ | — | $ | — | |||||||||||
State | — | — | — | ||||||||||||||
Deferred income tax expense (benefit): | |||||||||||||||||
Federal | — | — | — | ||||||||||||||
State | — | — | — | ||||||||||||||
Total income tax expense (benefit) | $ | — | $ | — | $ | — | |||||||||||
Reconciliation Between Statutory Tax Rate and Effective Tax Rate | The following is a reconciliation between the Company’s statutory tax rate and effective tax rate for the years ended December 31, 2014, 2013 and 2012: | ||||||||||||||||
Year Ended December 31, | |||||||||||||||||
2014 | 2013 | 2012 | |||||||||||||||
Federal tax at statutory rate | 34 | % | -34 | % | -34 | % | |||||||||||
State taxes | 7.2 | % | -4 | % | -3.3 | % | |||||||||||
Change in valuation allowance | -59.7 | % | 43.9 | % | 70.3 | % | |||||||||||
Research and development credit | 1.3 | % | -1.1 | % | 0.8 | % | |||||||||||
Orphan drug credit | 8.5 | % | -22.7 | % | -30.3 | % | |||||||||||
Stock options | 0 | % | 0 | % | 1.4 | % | |||||||||||
Section 162(m) limitation | 1.1 | % | 1.2 | % | 0 | % | |||||||||||
Stock issuance cost | 1.6 | % | 0 | % | 0 | % | |||||||||||
Tax rate change | 4.8 | % | -0.3 | % | -7 | % | |||||||||||
Change in Maryland NOL | 0 | % | 18.5 | % | 0 | % | |||||||||||
Other non-deductible items | 1.2 | % | -1.5 | % | 2.1 | % | |||||||||||
Effective tax rate | 0 | % | 0 | % | 0 | % | |||||||||||
Components of Deferred Tax Assets, Net, and Related Valuation Allowance | The following is a summary of the components of the Company’s deferred tax assets, net, and the related valuation allowance as of December 31, 2014 and 2013: | ||||||||||||||||
December 31, | |||||||||||||||||
(in thousands) | 2014 | 2013 | |||||||||||||||
Deferred tax assets: | |||||||||||||||||
Net operating loss carry forwards | $ | 73,626 | $ | 48,206 | |||||||||||||
Stock-based compensation | 17,160 | 17,626 | |||||||||||||||
Deferred revenue | — | 36,670 | |||||||||||||||
Accrued and deferred expenses | 532 | 566 | |||||||||||||||
Research and development and orphan drug credit carryforwards | 36,772 | 38,597 | |||||||||||||||
Depreciation and amortization, net | 118 | 110 | |||||||||||||||
Contributions carryforward | 420 | — | |||||||||||||||
Reacquired rights | 182 | — | |||||||||||||||
Licensing agreements | 86 | — | |||||||||||||||
Total deferred tax assets | 128,896 | 141,775 | |||||||||||||||
Deferred tax liabilities: | |||||||||||||||||
Licensing agreements | — | (616 | ) | ||||||||||||||
Unrealized gain on available for sale securities | (6 | ) | (9 | ) | |||||||||||||
Total deferred tax liabilities | (6 | ) | (625 | ) | |||||||||||||
Deferred tax assets | 128,890 | 141,150 | |||||||||||||||
Valuation allowance | (128,890 | ) | (141,150 | ) | |||||||||||||
Net deferred tax assets | $ | — | $ | — | |||||||||||||
Valuation Allowance Activity on Deferred Tax Assets | The valuation allowance activity on deferred tax assets was as follows: | ||||||||||||||||
(in thousands) | Balance At | Additions Charged | Reductions Credited | Balance At End | |||||||||||||
Beginning | To Income Tax | To Income Tax | Of Period | ||||||||||||||
Of Period | Expense | Expense | |||||||||||||||
Calendar year ended: | |||||||||||||||||
31-Dec-12 | $ | 113,823 | $ | 28,102 | $ | 8,654 | $ | 133,271 | |||||||||
31-Dec-13 | $ | 133,271 | $ | 22,998 | $ | 15,119 | $ | 141,150 | |||||||||
31-Dec-14 | $ | 141,150 | $ | 27,893 | $ | 40,153 | $ | 128,890 |
Fair_Value_Measurements_Tables
Fair Value Measurements (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Assets Measured at Fair Value on Recurring Basis | As of December 31, 2014, the Company held certain assets that are required to be measured at fair value on a recurring basis, as follows: | ||||||||||||||||
Fair Value Measurement as of December 31, 2014 Using | |||||||||||||||||
(in thousands) | December 31, | Quoted Prices in | Significant Other | Significant | |||||||||||||
2014 | Active Markets for | Observable Inputs | Unobservable | ||||||||||||||
Identical Assets | (Level 2) | Inputs | |||||||||||||||
(Level 1) | (Level 3) | ||||||||||||||||
Available-for-sale securities | $ | 68,921 | $ | 30,618 | $ | 38,303 | $ | — | |||||||||
As of December 31, 2013, the Company held certain assets that are required to be measured at fair value on a recurring basis, as follows: | |||||||||||||||||
Fair Value Measurement as of December 31, 2013 Using | |||||||||||||||||
(in thousands) | December 31, | Quoted Prices in | Significant Other | Significant | |||||||||||||
2013 | Active Markets for | Observable Inputs | Unobservable | ||||||||||||||
Identical Assets | (Level 2) | Inputs | |||||||||||||||
(Level 1) | (Level 3) | ||||||||||||||||
Available-for-sale securities | $ | 65,586 | $ | 31,566 | $ | 34,020 | $ | — |
Restricted_Cash_Tables
Restricted Cash (Tables) | 12 Months Ended | ||||||||
Dec. 31, 2014 | |||||||||
Summary of Restricted Cash Used to Collateralize Various Letters of Credit | The following is a summary of the Company’s restricted cash used to collateralize various letters of credit as of December 31, 2014 and 2013: | ||||||||
December 31, | |||||||||
(in thousands) | 2014 | 2013 | |||||||
Current: | |||||||||
Rockville, Maryland office lease | $ | — | $ | 430 | |||||
Maryland Board of Pharmacy license | — | 100 | |||||||
Total current | $ | — | $ | 530 | |||||
Non-current: | |||||||||
Washington, D.C. office lease | $ | 785 | $ | 500 | |||||
Maryland Board of Pharmacy license | — | — | |||||||
Total non-current | $ | 785 | $ | 500 | |||||
Equity_Incentive_Plans_Tables
Equity Incentive Plans (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Summary of RSU Activity for 2006 Plan | The following is a summary of RSU activity for the 2006 Plan for the years ended December 31, 2014, 2013, and 2012: | ||||||||||||||||
Number of | Weighted | ||||||||||||||||
Shares | Average | ||||||||||||||||
Underlying | Grant Date | ||||||||||||||||
RSUs | Fair Value | ||||||||||||||||
Unvested at December 31, 2011 | 522,346 | $ | 7.43 | ||||||||||||||
Granted | 245,000 | 3.28 | |||||||||||||||
Forfeited | (61,970 | ) | 7.64 | ||||||||||||||
Unvested at December 31, 2012 | 705,376 | 5.91 | |||||||||||||||
Granted | 400,500 | 10.29 | |||||||||||||||
Forfeited | (21,000 | ) | 6.41 | ||||||||||||||
Vested | (201,186 | ) | 6.71 | ||||||||||||||
Unvested at December 31, 2013 | 883,690 | 7.7 | |||||||||||||||
Granted | 436,115 | 12.28 | |||||||||||||||
Forfeited | (84,282 | ) | 6.75 | ||||||||||||||
Vested | (209,562 | ) | 6.67 | ||||||||||||||
Unvested at December 31, 2014 | 1,025,961 | 9.94 | |||||||||||||||
2004 Plan | |||||||||||||||||
Summary of Option Activity Plan | The following is a summary of option activity for the 2004 Plan for the years ended December 31, 2014, 2013, and 2012: | ||||||||||||||||
(in thousands, except for share and per share amounts) | Number of | Weighted Average | Weighted Average | Aggregate | |||||||||||||
Shares | Exercise Price at | Remaining Term | Intrinsic | ||||||||||||||
Grant Date | (Years) | Value | |||||||||||||||
Outstanding at December 31, 2011 | 677,145 | $ | 1.78 | 3.78 | $ | 2,016 | |||||||||||
Exercised | (5,000 | ) | 0.33 | 14 | |||||||||||||
Outstanding at December 31, 2012 | 672,145 | 1.79 | 2.78 | 1,512 | |||||||||||||
Exercised | (115 | ) | 4.73 | ||||||||||||||
Expired | (1,286 | ) | 3.67 | ||||||||||||||
Outstanding at December 31, 2013 | 670,744 | 1.79 | 1.78 | 7,124 | |||||||||||||
Exercised | (17,934 | ) | 3.57 | ||||||||||||||
Outstanding at December 31, 2014 | 652,810 | 1.74 | 0.78 | 8,212 | |||||||||||||
Exercisable at December 31, 2014 | 652,810 | 1.74 | 0.78 | 8,212 | |||||||||||||
2006 Plan | |||||||||||||||||
Summary of Option Activity Plan | The following is a summary of option activity for the 2006 Plan for the years ended December 31, 2014, 2013, and 2012: | ||||||||||||||||
(in thousands, except for share and per share amounts) | Number of | Weighted Average | Weighted Average | Aggregate | |||||||||||||
Shares | Exercise Price at | Remaining Term | Intrinsic | ||||||||||||||
Grant Date | (Years) | Value | |||||||||||||||
Outstanding at December 31, 2011 | 4,254,681 | $ | 12.16 | 7.65 | $ | 396 | |||||||||||
Granted | 846,000 | 3.42 | |||||||||||||||
Forfeited | (149,091 | ) | 7.5 | ||||||||||||||
Expired | (76,103 | ) | 10.68 | ||||||||||||||
Exercised | (10,000 | ) | 1.02 | 22 | |||||||||||||
Outstanding at December 31, 2012 | 4,865,487 | 10.83 | 7.15 | 634 | |||||||||||||
Granted | 1,245,500 | 10.18 | |||||||||||||||
Forfeited | (54,226 | ) | 6.14 | ||||||||||||||
Expired | (259,295 | ) | 10.65 | ||||||||||||||
Exercised | (263,848 | ) | 5.86 | 1,545 | |||||||||||||
Outstanding at December 31, 2013 | 5,533,618 | 10.98 | 6.93 | 21,264 | |||||||||||||
Granted | 1,324,337 | 12.17 | |||||||||||||||
Forfeited | (237,108 | ) | 8.35 | ||||||||||||||
Exercised | (393,735 | ) | 7.08 | 2,923 | |||||||||||||
Outstanding at December 31, 2014 | 6,227,112 | 11.58 | 6.71 | 28,523 | |||||||||||||
Exercisable at December 31, 2014 | 3,822,302 | 12.31 | 5.18 | 19,110 | |||||||||||||
Expected to vest at December 31, 2014 | 2,263,369 | 10.34 | 9.12 | 9,034 | |||||||||||||
Quarterly_Financial_Data_unaud1
Quarterly Financial Data (unaudited) (Tables) | 12 Months Ended | ||||||||||||||||
Dec. 31, 2014 | |||||||||||||||||
Quarterly Financial Data | |||||||||||||||||
(in thousands, except for per share amounts) | First | Second | Third | Fourth | |||||||||||||
Quarter | Quarter | Quarter | Quarter | ||||||||||||||
2014 | |||||||||||||||||
Revenue | $ | 9,143 | $ | 10,862 | $ | 14,782 | $ | 15,370 | |||||||||
Income (loss) from operations | (26,578 | ) | (21,606 | ) | (1,448 | ) | 69,693 | ||||||||||
Net income (loss) | (26,533 | ) | (21,575 | ) | (1,426 | ) | 69,719 | ||||||||||
Net income (loss) per share: | |||||||||||||||||
Basic | $ | (0.79 | ) | $ | (0.64 | ) | $ | (0.04 | ) | $ | 1.85 | ||||||
Diluted | $ | (0.79 | ) | $ | (0.64 | ) | $ | (0.04 | ) | $ | 1.77 | ||||||
2013 (1) | |||||||||||||||||
Revenue | $ | 8,068 | $ | 8,319 | $ | 8,709 | $ | 8,783 | |||||||||
Loss from operations | (4,565 | ) | (3,413 | ) | (5,431 | ) | (7,791 | ) | |||||||||
Net loss | (4,519 | ) | (3,383 | ) | (5,406 | ) | (7,747 | ) | |||||||||
Net loss per share, basic and diluted | $ | (0.16 | ) | $ | (0.12 | ) | $ | (0.17 | ) | $ | (0.23 | ) | |||||
-1 | In the first quarter of 2014, the Company elected to change its method of accounting for stock-based compensation from the accelerated attribution method to the straight-line method. The consolidated financial data above for the year ended 2013 has been adjusted to reflect this change. See Note 4, Change in Method of Accounting for Stock-based Compensation, for further discussion. |
Summary_of_Significant_Account2
Summary of Significant Accounting Policies - Additional Information (Detail) (USD $) | 12 Months Ended | |||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2009 | |
Segment | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Deferred revenue | $174,000 | $90,275,000 | $117,064,000 | |
Percentage of insurance coverage gap allocated for prescription drugs | 50.00% | |||
Advertising expenses | 5,000,000 | 0 | 0 | |
Number of business segment | 1 | |||
Fanapt | ||||
Summary Of Significant Accounting Policies [Line Items] | ||||
Deferred revenue | 200,000 | |||
Upfront payment received under Fanapt sublicense agreement from Novartis | $200,000,000 |
Total_Employee_StockBased_Comp
Total Employee Stock-Based Compensation Expense (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total employee stock-based compensation expense | $5,755 | $5,336 | $5,026 |
Research and development | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total employee stock-based compensation expense | 1,810 | 2,098 | 1,673 |
Selling, general and administrative | |||
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | |||
Total employee stock-based compensation expense | $3,945 | $3,238 | $3,353 |
BlackScholesMerton_Option_Pric
Black-Scholes-Merton Option Pricing Model for Employee and Director Stock Options Granted (Detail) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Share Based Payment Award Stock Options Valuation Assumptions [Line Items] | |||
Expected dividend yield | 0.00% | 0.00% | 0.00% |
Weighted average expected volatility | 62.00% | 65.00% | 68.00% |
Weighted average expected term (years) | 5 years 10 months 24 days | 6 years 11 days | 6 years 11 days |
Weighted average risk-free rate | 1.73% | 1.59% | 0.94% |
Weighted average fair value per share | $6.99 | $6.10 | $2.08 |
Settlement_Agreement_with_Nova2
Settlement Agreement with Novartis - Additional Information (Detail) (USD $) | 1 Months Ended | 3 Months Ended | 12 Months Ended | 1 Months Ended | |||
Oct. 31, 2014 | Aug. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2009 | |
Business Acquisition [Line Items] | |||||||
Net proceeds from offering of common stock | $62,313,000 | $48,505,000 | $62,313,000 | $48,505,000 | |||
Intangible assets, amortization method | Straight-line basis | ||||||
Intangible assets, amortizing period end date | 2016-11 | ||||||
Non-recurring transaction costs elated to the acquisition | 600,000 | 600,000 | 600,000 | ||||
Date of acquisition | 1-Jan-13 | ||||||
Gain on termination of pre-existing non-contractual relationship | 77,600,000 | 77,616,000 | |||||
Fanapt | |||||||
Business Acquisition [Line Items] | |||||||
Intangible assets, amortizing period end date | 2016-11 | 2016-11 | 2027-11 | ||||
Gain on termination of pre-existing non-contractual relationship | 18,100,000 | ||||||
Upfront payment received | 200,000,000 | ||||||
Up-front Payment Arrangement | |||||||
Business Acquisition [Line Items] | |||||||
Gain on termination of pre-existing non-contractual relationship | 59,500,000 | ||||||
Settlement Agreement | |||||||
Business Acquisition [Line Items] | |||||||
Net proceeds from offering of common stock | 25,000,000 | ||||||
Effective date of the Settlement Agreement | 31-Dec-14 | ||||||
Gain on termination of pre-existing non-contractual relationship | 18,087,000 | ||||||
Novartis Pharma AG | |||||||
Business Acquisition [Line Items] | |||||||
Net proceeds from offering of common stock | 25,000,000 | ||||||
Intangible assets, amortizing period end date | 2016-11 | ||||||
Novartis Pharma AG | Settlement Agreement | |||||||
Business Acquisition [Line Items] | |||||||
Net proceeds from offering of common stock | 25,000,000 | ||||||
Price per share | 13.82 | ||||||
Stock issued during period, shares | 1,808,973 | ||||||
Percentage of premium to average closing prices | 10.00% | 10.00% | 10.00% | ||||
Trading days | 10 days | ||||||
Gain (Loss) on issuance of stock | 900,000 |
Fair_Value_of_Consideration_Ex
Fair Value of Consideration Exchanged as Part of Settlement Agreement (Detail) (USD $) | 1 Months Ended | 3 Months Ended | 12 Months Ended | ||
In Thousands, unless otherwise specified | Oct. 31, 2014 | Aug. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2014 | Dec. 31, 2013 |
Business Acquisition [Line Items] | |||||
Equity issued | $25,905 | ||||
Cash received | -62,313 | -48,505 | -62,313 | -48,505 | |
Settlement of pre-existing non-contractual relationship | 77,600 | 77,616 | |||
Settlement Agreement | |||||
Business Acquisition [Line Items] | |||||
Equity issued | 25,904 | ||||
Cash received | -25,000 | ||||
Settlement of pre-existing non-contractual relationship | 18,087 | ||||
Business Combination, Consideration Transferred, Total | $18,991 |
Assets_Acquired_and_Recorded_a
Assets Acquired and Recorded at Fair Value (Detail) (USD $) | 12 Months Ended | |
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Business Acquisition [Line Items] | ||
Assets acquired and recorded at fair value, Inventory | $2,960 | |
Assets acquired and recorded at fair value, Intangible - Re-acquired right | 15,940 | |
Assets acquired and recorded at fair value, Prepaid services | 91 | |
Assets acquired and recorded at fair value | 18,991 | |
Revenue | 79,335 | 75,270 |
Net income (loss) | ($100,742) | $41,048 |
Basic income (loss) per share | ($2.90) | $1.35 |
Diluted income (loss) per share | ($2.90) | $1.29 |
Change_in_Method_of_Accounting2
Change in Method of Accounting for Stock-based Compensation - Additional Information (Detail) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2011 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Accumulated deficit | ($287,984,000) | ($308,170,000) | |
Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
New Accounting Pronouncement or Change in Accounting Principle, Effect of Change on share based compensation | 2,200,000 | ||
New Accounting Pronouncement or Change in Accounting Principle, Effect of Change on Net Income | 2,200,000 | ||
New Accounting Pronouncement or Change in Accounting Principle, Effect of Change on Earnings Per Share | $0.06 | ||
Accumulated deficit | -258,498,000 | ||
Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | Retrospective Adjustment | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Accumulated deficit | $4,945,000 |
Adjustments_in_Balance_Sheet_D
Adjustments in Balance Sheet (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
In Thousands, unless otherwise specified | ||||
Stockholders' equity: | ||||
Preferred stock, $0.001 par value; 20,000,000 shares authorized, and no shares issued or outstanding | ||||
Common stock, $0.001 par value; 150,000,000 shares authorized; 28,117,026 shares issued and outstanding at December 31, 2011 | 41 | 33 | ||
Additional paid-in capital | 448,744 | 352,240 | ||
Accumulated other comprehensive income | 16 | 21 | ||
Accumulated deficit | -287,984 | -308,170 | ||
Total stockholders' equity | 160,817 | 44,124 | 9,905 | 33,474 |
Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | ||||
Stockholders' equity: | ||||
Preferred stock, $0.001 par value; 20,000,000 shares authorized, and no shares issued or outstanding | ||||
Common stock, $0.001 par value; 150,000,000 shares authorized; 28,117,026 shares issued and outstanding at December 31, 2011 | 28 | |||
Additional paid-in capital | 291,923 | |||
Accumulated other comprehensive income | 21 | |||
Accumulated deficit | -258,498 | |||
Total stockholders' equity | 33,474 | |||
As Previously Reported | ||||
Stockholders' equity: | ||||
Total stockholders' equity | 33,474 | |||
As Previously Reported | Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | ||||
Stockholders' equity: | ||||
Preferred stock, $0.001 par value; 20,000,000 shares authorized, and no shares issued or outstanding | ||||
Common stock, $0.001 par value; 150,000,000 shares authorized; 28,117,026 shares issued and outstanding at December 31, 2011 | 28 | |||
Additional paid-in capital | 296,868 | |||
Accumulated other comprehensive income | 21 | |||
Accumulated deficit | -263,443 | |||
Total stockholders' equity | 33,474 | |||
Retrospective Adjustment | Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | ||||
Stockholders' equity: | ||||
Preferred stock, $0.001 par value; 20,000,000 shares authorized, and no shares issued or outstanding | ||||
Additional paid-in capital | -4,945 | |||
Accumulated deficit | $4,945 |
Adjustments_in_Balance_Sheet_P
Adjustments in Balance Sheet (Parenthetical) (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2011 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Preferred stock, par value | $0.00 | $0.00 | |
Preferred stock, shares authorized | 20,000,000 | 20,000,000 | |
Preferred stock, shares issued | 0 | 0 | |
Preferred stock, shares outstanding | 0 | 0 | |
Common stock, par value | $0.00 | $0.00 | |
Common stock, shares authorized | 150,000,000 | 150,000,000 | |
Common stock, shares issued | 41,486,361 | 33,338,543 | |
Common stock, shares outstanding | 41,486,361 | 33,338,543 | |
Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Preferred stock, par value | $0.00 | ||
Preferred stock, shares authorized | 20,000,000 | ||
Preferred stock, shares issued | 0 | ||
Preferred stock, shares outstanding | 0 | ||
Common stock, par value | $0.00 | ||
Common stock, shares authorized | 150,000,000 | ||
Common stock, shares issued | 28,117,026 | ||
Common stock, shares outstanding | 28,117,026 | ||
Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | As Previously Reported | |||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||
Preferred stock, par value | $0.00 | ||
Preferred stock, shares authorized | 20,000,000 | ||
Preferred stock, shares issued | 0 | ||
Preferred stock, shares outstanding | 0 | ||
Common stock, par value | $0.00 | ||
Common stock, shares authorized | 150,000,000 | ||
Common stock, shares issued | 28,117,026 | ||
Common stock, shares outstanding | 28,117,026 |
Adjustments_in_Statement_of_Op
Adjustments in Statement of Operations (Detail) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||||||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | ||||
Revenues: | |||||||||||||||
Licensing agreement | $30,746 | $26,789 | $26,789 | ||||||||||||
Royalty revenue | 6,502 | 7,090 | 5,938 | ||||||||||||
Total revenues | 15,370 | 14,782 | 10,862 | 9,143 | 8,783 | [1] | 8,709 | [1] | 8,319 | [1] | 8,068 | [1] | 50,157 | 33,879 | 32,727 |
Operating expenses: | |||||||||||||||
Cost of goods sold | 1,583 | 129 | |||||||||||||
Research and development | 19,230 | 28,502 | 45,764 | ||||||||||||
Selling, general and administrative | 84,644 | 25,082 | 14,517 | ||||||||||||
Intangible asset amortization | 2,254 | 1,495 | 1,495 | ||||||||||||
Total operating expenses | 30,095 | 55,079 | 61,905 | ||||||||||||
Loss from operations | 69,693 | -1,448 | -21,606 | -26,578 | -7,791 | [1] | -5,431 | [1] | -3,413 | [1] | -4,565 | [1] | 20,062 | -21,200 | -29,178 |
Other income | 124 | 145 | 561 | ||||||||||||
Tax benefit | 0 | ||||||||||||||
Net income (loss) | 69,719 | -1,426 | -21,575 | -26,533 | -7,747 | [1] | -5,406 | [1] | -3,383 | [1] | -4,519 | [1] | 20,186 | -21,055 | -28,617 |
Basic and diluted net loss per share | ($0.23) | [1] | ($0.17) | [1] | ($0.12) | [1] | ($0.16) | [1] | |||||||
Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | |||||||||||||||
Revenues: | |||||||||||||||
Licensing agreement | 26,789 | 26,789 | |||||||||||||
Royalty revenue | 7,090 | 5,938 | |||||||||||||
Total revenues | 33,879 | 32,727 | |||||||||||||
Operating expenses: | |||||||||||||||
Cost of goods sold | 129 | ||||||||||||||
Research and development | 28,502 | 45,764 | |||||||||||||
Selling, general and administrative | 25,082 | 14,517 | |||||||||||||
Intangible asset amortization | 1,495 | 1,495 | |||||||||||||
Total operating expenses | 55,079 | 61,905 | |||||||||||||
Loss from operations | -21,200 | -29,178 | |||||||||||||
Other income | 145 | 561 | |||||||||||||
Loss before tax benefit | -21,055 | -28,617 | |||||||||||||
Tax benefit | 0 | 0 | |||||||||||||
Net income (loss) | -21,055 | -28,617 | |||||||||||||
Basic and diluted net loss per share | ($0.69) | ($1.01) | |||||||||||||
Weighted average shares outstanding, basic and diluted | 30,351,353 | 28,228,409 | |||||||||||||
As Previously Reported | Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | |||||||||||||||
Revenues: | |||||||||||||||
Licensing agreement | 26,789 | 26,789 | |||||||||||||
Royalty revenue | 7,090 | 5,938 | |||||||||||||
Total revenues | 33,879 | 32,727 | |||||||||||||
Operating expenses: | |||||||||||||||
Cost of goods sold | 129 | ||||||||||||||
Research and development | 28,190 | 45,446 | |||||||||||||
Selling, general and administrative | 24,594 | 13,882 | |||||||||||||
Intangible asset amortization | 1,495 | 1,495 | |||||||||||||
Total operating expenses | 54,279 | 60,952 | |||||||||||||
Loss from operations | -20,400 | -28,225 | |||||||||||||
Other income | 145 | 561 | |||||||||||||
Loss before tax benefit | -20,255 | -27,664 | |||||||||||||
Tax benefit | 0 | 0 | |||||||||||||
Net income (loss) | -20,255 | -27,664 | |||||||||||||
Basic and diluted net loss per share | ($0.67) | ($0.98) | |||||||||||||
Weighted average shares outstanding, basic and diluted | 30,351,353 | 28,228,409 | |||||||||||||
Retrospective Adjustment | Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | |||||||||||||||
Operating expenses: | |||||||||||||||
Research and development | 312 | 318 | |||||||||||||
Selling, general and administrative | 488 | 635 | |||||||||||||
Total operating expenses | 800 | 953 | |||||||||||||
Loss from operations | -800 | -953 | |||||||||||||
Loss before tax benefit | -800 | -953 | |||||||||||||
Tax benefit | 0 | 0 | |||||||||||||
Net income (loss) | ($800) | ($953) | |||||||||||||
Basic and diluted net loss per share | ($0.02) | ($0.03) | |||||||||||||
[1] | In the first quarter of 2014, the Company elected to change its method of accounting for stock-based compensation from the accelerated attribution method to the straight-line method. The consolidated financial data above for the year ended 2013 has been adjusted to reflect this change. See Note 4, Change in Method of Accounting for Stock-based Compensation, for further discussion. |
Adjustments_in_Statement_of_Co
Adjustments in Statement of Comprehensive Loss (Detail) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||||||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | ||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||||||||
Net loss | $69,719 | ($1,426) | ($21,575) | ($26,533) | ($7,747) | [1] | ($5,406) | [1] | ($3,383) | [1] | ($4,519) | [1] | $20,186 | ($21,055) | ($28,617) |
Other comprehensive income (loss): | |||||||||||||||
Change in net unrealized loss on marketable securities | -5 | 11 | -11 | ||||||||||||
Tax provision on other comprehensive income (loss) | 0 | 0 | 0 | ||||||||||||
Other comprehensive income (loss), net of tax: | -5 | 11 | -11 | ||||||||||||
Comprehensive loss | 20,181 | -21,044 | -28,628 | ||||||||||||
Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | |||||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||||||||
Net loss | -21,055 | -28,617 | |||||||||||||
Other comprehensive income (loss): | |||||||||||||||
Change in net unrealized loss on marketable securities | 11 | -11 | |||||||||||||
Tax provision on other comprehensive income (loss) | 0 | 0 | |||||||||||||
Other comprehensive income (loss), net of tax: | 11 | -11 | |||||||||||||
Comprehensive loss | -21,044 | -28,628 | |||||||||||||
As Previously Reported | Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | |||||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||||||||
Net loss | -20,255 | -27,664 | |||||||||||||
Other comprehensive income (loss): | |||||||||||||||
Change in net unrealized loss on marketable securities | 11 | -11 | |||||||||||||
Tax provision on other comprehensive income (loss) | 0 | 0 | |||||||||||||
Other comprehensive income (loss), net of tax: | 11 | -11 | |||||||||||||
Comprehensive loss | -20,244 | -27,675 | |||||||||||||
Retrospective Adjustment | Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | |||||||||||||||
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | |||||||||||||||
Net loss | -800 | -953 | |||||||||||||
Other comprehensive income (loss): | |||||||||||||||
Tax provision on other comprehensive income (loss) | 0 | 0 | |||||||||||||
Comprehensive loss | ($800) | ($953) | |||||||||||||
[1] | In the first quarter of 2014, the Company elected to change its method of accounting for stock-based compensation from the accelerated attribution method to the straight-line method. The consolidated financial data above for the year ended 2013 has been adjusted to reflect this change. See Note 4, Change in Method of Accounting for Stock-based Compensation, for further discussion. |
Adjustments_in_Statement_of_Ca
Adjustments in Statement of Cash Flows (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Cash flows from operating activities | |||
Net loss | $20,186 | ($21,055) | ($28,617) |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization of property and equipment | 530 | 432 | 633 |
Employee and non-employee stock-based compensation | 5,878 | 5,404 | 5,047 |
Amortization of discounts and premiums on marketable securities | -174 | -155 | -560 |
Intangible asset amortization | 2,254 | 1,495 | 1,495 |
Landlord contributions for tenant improvements | 1,826 | ||
Net cash used in operating activities | -81,554 | -39,592 | -44,917 |
Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | |||
Cash flows from operating activities | |||
Net loss | -21,055 | -28,617 | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization of property and equipment | 432 | 633 | |
Employee and non-employee stock-based compensation | 5,404 | 5,047 | |
Amortization of discounts and premiums on marketable securities | 155 | 560 | |
Intangible asset amortization | 1,495 | 1,495 | |
Landlord contributions for tenant improvements | 1,826 | ||
Changes in assets and liabilities, net | -26,023 | -25,861 | |
Net cash used in operating activities | -39,592 | -44,917 | |
As Previously Reported | Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | |||
Cash flows from operating activities | |||
Net loss | -20,255 | -27,664 | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Depreciation and amortization of property and equipment | 432 | 633 | |
Employee and non-employee stock-based compensation | 4,604 | 4,094 | |
Amortization of discounts and premiums on marketable securities | 155 | 560 | |
Intangible asset amortization | 1,495 | 1,495 | |
Landlord contributions for tenant improvements | 1,826 | ||
Changes in assets and liabilities, net | -26,023 | -25,861 | |
Net cash used in operating activities | -39,592 | -44,917 | |
Retrospective Adjustment | Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | |||
Cash flows from operating activities | |||
Net loss | -800 | -953 | |
Adjustments to reconcile net loss to net cash used in operating activities: | |||
Employee and non-employee stock-based compensation | $800 | $953 |
Basic_and_Diluted_Net_Income_L
Basic and Diluted Net Income (Loss) Per Share of Common Stock (Detail) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||||||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | ||||
Numerator: | |||||||||||||||
Net income (loss) | $69,719 | ($1,426) | ($21,575) | ($26,533) | ($7,747) | [1] | ($5,406) | [1] | ($3,383) | [1] | ($4,519) | [1] | $20,186 | ($21,055) | ($28,617) |
Denominator: | |||||||||||||||
Weighted average shares outstanding: Basic | 34,774,163 | 30,351,353 | 28,228,409 | ||||||||||||
Effect of dilutive securities | 1,912,560 | ||||||||||||||
Weighted average shares outstanding: Diluted | 36,686,723 | 30,351,353 | 28,228,409 | ||||||||||||
Net income (loss) per share, basic and diluted: | |||||||||||||||
Basic | $1.85 | ($0.04) | ($0.64) | ($0.79) | $0.58 | ($0.69) | ($1.01) | ||||||||
Diluted | $1.77 | ($0.04) | ($0.64) | ($0.79) | $0.55 | ($0.69) | ($1.01) | ||||||||
Antidilutive securities excluded from calculations of diluted net income (loss) per share | 3,524,656 | 4,409,811 | 5,462,476 | ||||||||||||
[1] | In the first quarter of 2014, the Company elected to change its method of accounting for stock-based compensation from the accelerated attribution method to the straight-line method. The consolidated financial data above for the year ended 2013 has been adjusted to reflect this change. See Note 4, Change in Method of Accounting for Stock-based Compensation, for further discussion. |
Summary_of_AvailableForSale_Ma
Summary of Available-For-Sale Marketable Securities (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Fair Market Value | $68,921 | $65,586 |
Current Investment | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 68,905 | 65,565 |
Gross Unrealized Gains | 29 | 27 |
Gross Unrealized Losses | -13 | -6 |
Fair Market Value | 68,921 | 65,586 |
Current Investment | U.S. Treasury and government agencies | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 30,618 | 31,557 |
Gross Unrealized Gains | 4 | 9 |
Gross Unrealized Losses | -4 | |
Fair Market Value | 30,618 | 31,566 |
Current Investment | Corporate debt | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 38,287 | 34,008 |
Gross Unrealized Gains | 25 | 18 |
Gross Unrealized Losses | -9 | -6 |
Fair Market Value | $38,303 | $34,020 |
Accounts_Receivable_Additional
Accounts Receivable - Additional Information (Detail) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Accounts, Notes, Loans and Financing Receivable [Line Items] | |||
Royalty receivable | $1,600,000 | $2,000,000 | |
Bad debt expense | 0 | 0 | 0 |
Allowance for doubtful accounts | $0 | $0 |
Inventory_Detail
Inventory (Detail) (USD $) | Dec. 31, 2014 |
In Thousands, unless otherwise specified | |
Inventory [Line Items] | |
Raw materials | $198 |
Work-in-process | 1,326 |
Finished goods | 3,394 |
Deferred cost of goods sold | 252 |
Total | $5,170 |
Summary_of_Prepaid_Expenses_an
Summary of Prepaid Expenses and Other Current Assets (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Prepaid Expenses And Other Current Assets [Line Items] | ||
Prepaid insurance | $270 | $167 |
Prepaid manufacturing cost | 358 | |
Other prepaid expenses and vendor advances | 2,302 | 2,408 |
Other current assets | 154 | 128 |
Total prepaid expenses and other current assets | $3,084 | $2,703 |
Summary_of_Property_and_Equipm
Summary of Property and Equipment-at Cost (Detail) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment, gross | $4,170 | $3,447 |
Accumulated depreciation and amortization | -1,733 | -1,249 |
Property and equipment, net | 2,437 | 2,198 |
Computer equipment | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 3 years | |
Property and equipment, gross | 1,316 | 983 |
Furniture and fixtures | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 7 years | |
Property and equipment, gross | 765 | 580 |
Leasehold improvements | ||
Property, Plant and Equipment [Line Items] | ||
Estimated Useful Life (Years) | 11 years | |
Property and equipment, gross | $2,089 | $1,884 |
Property_and_Equipment_Additio
Property and Equipment - Additional Information (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Property, Plant and Equipment [Line Items] | |||
Depreciation and amortization of property and equipment | $530 | $432 | $633 |
Summary_of_Intangible_Assets_D
Summary of Intangible Assets (Detail) (USD $) | 1 Months Ended | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2014 | Dec. 31, 2013 |
Finite-Lived Intangible Assets [Line Items] | |||
Estimated Patent life end date | 2016-11 | ||
Net Carrying Amount | $26,724 | $26,724 | $5,037 |
Hetlioz | |||
Finite-Lived Intangible Assets [Line Items] | |||
Estimated Patent life end date | 2033-01 | ||
Gross Carrying Amount | 8,000 | 8,000 | |
Accumulated Amortization | 539 | 539 | |
Net Carrying Amount | 7,461 | 7,461 | |
Fanapt | |||
Finite-Lived Intangible Assets [Line Items] | |||
Estimated Patent life end date | 2027-11 | 2016-11 | 2016-11 |
Gross Carrying Amount | 27,941 | 27,941 | 12,000 |
Accumulated Amortization | 8,678 | 8,678 | 6,963 |
Net Carrying Amount | $19,263 | $19,263 | $5,037 |
Intangible_Assets_Additional_I
Intangible Assets - Additional Information (Detail) (USD $) | 1 Months Ended | 12 Months Ended | 1 Months Ended | 12 Months Ended | ||||||
In Thousands, unless otherwise specified | Feb. 28, 2004 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Jan. 31, 2014 | Jul. 31, 2013 | Dec. 31, 2014 | 31-May-09 | Dec. 31, 2009 | Dec. 31, 2004 |
Finite-Lived Intangible Assets [Line Items] | ||||||||||
Payment for original sublicense agreement | $500 | $8,000 | ||||||||
Estimated Patent life end date | 2016-11 | |||||||||
Recognized intangible assets | 15,940 | 15,940 | ||||||||
Intangible asset amortization | 2,254 | 1,495 | 1,495 | |||||||
Intangible - Re-acquired right | ||||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||||
Recognized intangible assets | 15,900 | 15,900 | ||||||||
Hetlioz | ||||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||||
Payment for original sublicense agreement | 8,000 | 3,000 | ||||||||
Estimated Patent life end date | 2033-01 | |||||||||
Hetlioz | Minimum | ||||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||||
Estimated Patent life end date | 2022-12 | |||||||||
Hetlioz | Maximum | ||||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||||
Estimated Patent life end date | 2033-01 | |||||||||
Fanapt | ||||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||||
Payment for original sublicense agreement | $12,000 | $12,000 | $500 | |||||||
Estimated Patent life end date | 2016-11 | 2016-11 | 2027-11 | |||||||
Fanapt | Minimum | ||||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||||
Estimated Patent life end date | 2016-11 | |||||||||
Fanapt | Maximum | ||||||||||
Finite-Lived Intangible Assets [Line Items] | ||||||||||
Estimated Patent life end date | 2017-05 |
Summary_of_Future_Intangible_A
Summary of Future Intangible Asset Amortization (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Finite-Lived Intangible Assets [Line Items] | ||
Net Carrying Amount | $26,724 | $5,037 |
2015 | 10,461 | |
2016 | 9,624 | |
2017 | 411 | |
2018 | 411 | |
2019 | 411 | |
Thereafter | 5,406 | |
Hetlioz | ||
Finite-Lived Intangible Assets [Line Items] | ||
Net Carrying Amount | 7,461 | |
2015 | 411 | |
2016 | 411 | |
2017 | 411 | |
2018 | 411 | |
2019 | 411 | |
Thereafter | 5,406 | |
Fanapt | ||
Finite-Lived Intangible Assets [Line Items] | ||
Net Carrying Amount | 19,263 | 5,037 |
2015 | 10,050 | |
2016 | $9,213 |
Summary_of_Accrued_Liabilities
Summary of Accrued Liabilities (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Accrued Liabilities [Line Items] | ||
Accrued research and development expenses | $1,759 | $2,324 |
Accrued consulting and other professional fees | 2,522 | 2,015 |
Compensation and employee benefits | 388 | 176 |
Other accrued liabilities | 1,833 | 665 |
Accrued liabilities | $6,502 | $5,180 |
Summary_of_Changes_in_Total_De
Summary of Changes in Total Deferred Revenue (Detail) (USD $) | 12 Months Ended | |
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 |
Deferred Revenue Arrangement [Line Items] | ||
Balance beginning of period | $90,275 | $117,064 |
Deferred FanaptB.product sales | 174 | |
Licensing revenue recognized | 30,746 | 26,789 |
Recognized as part of gain on arbitration settlement | 59,529 | |
Balance end of period | $174 | $90,275 |
Deferred_Revenue_Additional_In
Deferred Revenue - Additional Information (Detail) (USD $) | 3 Months Ended | 12 Months Ended | |||
Dec. 31, 2014 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2009 | |
Deferred Revenue Arrangement [Line Items] | |||||
Licensing agreement | $30,746,000 | $26,789,000 | $26,789,000 | ||
Recognized as part of gain on arbitration settlement | 77,600,000 | 77,616,000 | |||
Up-front Payment Arrangement | |||||
Deferred Revenue Arrangement [Line Items] | |||||
Recognized as part of gain on arbitration settlement | 59,500,000 | ||||
Fanapt | |||||
Deferred Revenue Arrangement [Line Items] | |||||
Upfront payment received | 200,000,000 | ||||
Recognized as part of gain on arbitration settlement | $18,100,000 |
Summary_of_Minimum_Annual_Futu
Summary of Minimum Annual Future Payments Under Operating Leases (Detail) (USD $) | Dec. 31, 2014 |
In Thousands, unless otherwise specified | |
Operating Leased Assets [Line Items] | |
Operating leases, Total | $14,710 |
Operating leases, 2015 | 1,395 |
Operating leases, 2016 | 1,500 |
Operating leases, 2017 | 1,538 |
Operating leases, 2018 | 1,576 |
Operating leases, 2019 | 1,616 |
Operating leases, Thereafter | $7,085 |
Commitments_and_Contingencies_1
Commitments and Contingencies - Additional Information (Detail) (USD $) | 12 Months Ended | 1 Months Ended | |||
In Millions, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | Mar. 31, 2014 |
sqft | sqft | ||||
Commitments and Contingencies Disclosure [Line Items] | |||||
Rent expense | $1.70 | $1.10 | $2 | ||
Washington DC Lease | |||||
Commitments and Contingencies Disclosure [Line Items] | |||||
Renewal term of Lease agreement | 5 years | ||||
Square feet leased | 21,400 | ||||
Allowance for tenant improvements | 1.9 | ||||
Washington DC Lease Amendment | |||||
Commitments and Contingencies Disclosure [Line Items] | |||||
Renewal term of Lease agreement | 5 years | ||||
Square feet leased | 8,860 | ||||
Allowance for tenant improvements | 0.8 | ||||
Lease term | 12 years 1 month | ||||
Additional annual rental payment under lease amendment | $0.40 |
Commitments_and_Contingencies_2
Commitments and Contingencies (Textual 1 - Consulting Agreement) - Additional Information (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Consulting Fees | |||
Research and development | $19,230 | $28,502 | $45,764 |
Consulting Agreement | |||
Consulting Fees | |||
Research and development | $2,000 | $500 |
Commitments_and_Contingencies_3
Commitments and Contingencies (Textual 2 - HETLIOZ) - Additional Information (Detail) (USD $) | 1 Months Ended | 12 Months Ended | 1 Months Ended | 3 Months Ended | |
Feb. 28, 2004 | Dec. 31, 2014 | Jan. 31, 2014 | Jul. 31, 2013 | Mar. 31, 2014 | |
HETLIOZ | |||||
Milestone payment under license agreement | $500,000 | $8,000,000 | |||
Percentage of future sublicense fees payable to third-party | Mid-twenties | ||||
Maximum | In the event that cumulative sales of HETLIOZ reach $250.0 million | |||||
HETLIOZ | |||||
Possible future milestone payment in the event product reaches a certain agreed upon sales threshold | 25,000,000 | ||||
License Agreement | |||||
HETLIOZ | |||||
Milestone payment under license agreement | 1,000,000 | ||||
Hetlioz | |||||
HETLIOZ | |||||
Milestone payment under license agreement | 8,000,000 | 3,000,000 | |||
Royalty percentage | 10.00% | ||||
Hetlioz | License Agreement | |||||
HETLIOZ | |||||
Milestone payment under license agreement | $8,000,000 |
Commitments_and_Contingencies_4
Commitments and Contingencies (Textual 3 - Fanapt) - Additional Information (Detail) (USD $) | 1 Months Ended | 12 Months Ended | 1 Months Ended | 12 Months Ended | |||
Feb. 28, 2004 | Dec. 31, 2014 | Dec. 31, 2014 | 31-May-09 | Dec. 31, 2013 | Dec. 31, 2009 | Dec. 31, 2004 | |
Fanapt | |||||||
Milestone payment under license agreement | $500,000 | $8,000,000 | |||||
Intangible assets, amortizing period end date | 2016-11 | ||||||
Novartis Pharma AG | |||||||
Fanapt | |||||||
Intangible assets, amortizing period end date | 2016-11 | ||||||
Novartis Pharma AG | Through November 2016 | |||||||
Fanapt | |||||||
Royalty percentage | 23.00% | ||||||
Novartis Pharma AG | Royalty Rate for Annual Sales in Excess of $200 million | |||||||
Fanapt | |||||||
Future royalty payments to Novartis based on sales | mid-twenties | ||||||
Novartis Pharma AG | Beyond November 2016 | |||||||
Fanapt | |||||||
Royalty percentage | 9.00% | ||||||
Maximum | Novartis Pharma AG | |||||||
Fanapt | |||||||
Possible future milestone payment agreed upon sales threshold | 200,000,000 | ||||||
Fanapt | |||||||
Fanapt | |||||||
Milestone payment under license agreement | 12,000,000 | 12,000,000 | 500,000 | ||||
Future royalty payments to Novartis based on sales | mid-twenties | ||||||
Upfront payment received | 200,000,000 | ||||||
Potential future maximum milestone payments from Novartis | 265,000,000 | ||||||
Intangible assets, amortizing period end date | 2016-11 | 2027-11 | 2016-11 | ||||
Fanapt | Maximum | |||||||
Fanapt | |||||||
Possible future Fanapt maximum milestone payments to Novartis | $100,000,000 | ||||||
Intangible assets, amortizing period end date | 2017-05 |
Commitments_and_Contingencies_5
Commitments and Contingencies (Textual 4 - VLY 686) - Additional Information (Detail) (Tradipitant, USD $) | 12 Months Ended | |
In Millions, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2012 |
VLY-686 | ||
Future percentage of royalty payments based net sales | Low double digits | |
Possible future milestone payments | $4 | |
Milestone payment under license agreement | 1 | |
License Agreement | ||
VLY-686 | ||
Possible future milestone payments | $95 |
Commitments_and_Contingencies_6
Commitments and Contingencies (Textual 5 - Future Milestone Payments) - Additional Information (Detail) (USD $) | Dec. 31, 2014 |
Future milestone payments | |
Liabilities recorded, future license payments | $0 |
Liabilities recorded, contractual obligations relating to the license agreements | $0 |
Commitments_and_Contingencies_7
Commitments and Contingencies (Textual 6 - Agreements) - Additional Information (Detail) (Maximum) | 12 Months Ended |
Dec. 31, 2014 | |
Maximum | |
Agreements | |
Clinical services agreement notice period for termination | 60 days |
Summary_of_Current_and_Deferre
Summary of Current and Deferred Income Tax Provision (Benefit) (Detail) (USD $) | 12 Months Ended |
In Thousands, unless otherwise specified | Dec. 31, 2014 |
Current income tax expense (benefit): | |
Federal | $0 |
State | 0 |
Deferred income tax expense (benefit): | |
Federal | 0 |
State | 0 |
Total income tax expense (benefit) | $0 |
Reconciliation_Between_Statuto
Reconciliation Between Statutory Tax Rate and Effective Tax Rate (Detail) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Income Tax Rate Reconciliation [Line Items] | |||
Federal tax at statutory rate | 34.00% | -34.00% | -34.00% |
State taxes | 7.20% | -4.00% | -3.30% |
Change in valuation allowance | -59.70% | 43.90% | 70.30% |
Research and development credit | 1.30% | -1.10% | 0.80% |
Orphan drug credit | 8.50% | -22.70% | -30.30% |
Stock options | 0.00% | 0.00% | 1.40% |
Section 162(m) limitation | 1.10% | 1.20% | 0.00% |
Stock issuance cost | 1.60% | 0.00% | 0.00% |
Tax rate change | 4.80% | -0.30% | -7.00% |
Other non-deductible items | 1.20% | -1.50% | 2.10% |
Effective tax rate | 0.00% | 0.00% | 0.00% |
Maryland | |||
Income Tax Rate Reconciliation [Line Items] | |||
Change in valuation allowance | 0.00% | 18.50% | 0.00% |
Components_of_Deferred_Tax_Ass
Components of Deferred Tax Assets, Net and Related Valuation Allowance (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Deferred tax assets: | ||
Net operating loss carry forwards | $73,626 | $48,206 |
Stock-based compensation | 17,160 | 17,626 |
Deferred revenue | 36,670 | |
Accrued and deferred expenses | 532 | 566 |
Research and development and orphan drug credit carryforwards | 36,772 | 38,597 |
Depreciation and amortization, net | 118 | 110 |
Contributions carryforward | 420 | |
Reacquired rights | 182 | |
Licensing agreements | 86 | |
Total deferred tax assets | 128,896 | 141,775 |
Deferred tax liabilities: | ||
Licensing agreements | -616 | |
Unrealized gain on available for sale securities | -6 | -9 |
Total deferred tax liabilities | -6 | -625 |
Deferred tax assets | 128,890 | 141,150 |
Valuation allowance | -128,890 | -141,150 |
Net deferred tax assets | $0 | $0 |
Income_Taxes_Additional_Inform
Income Taxes - Additional Information (Detail) (USD $) | 12 Months Ended | ||
In Millions, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Income Taxes [Line Items] | |||
Increase (decrease) in tax valuation allowance, net | ($12.30) | $7.90 | $19.40 |
Net operating loss carryforwards beginning expiration year | 2028 | ||
Carryforward credits beginning expiration year | 2024 | ||
Federal | |||
Income Taxes [Line Items] | |||
Operating loss carryforwards, net | 197.4 | ||
State | |||
Income Taxes [Line Items] | |||
Operating loss carryforwards, net | 201.3 | ||
Operating loss carryforwards, excess windfall benefits generated from stock options | 4.2 | ||
Orphan Drug | |||
Income Taxes [Line Items] | |||
Tax credits carryforwards | 30.6 | ||
Research and development | |||
Income Taxes [Line Items] | |||
Tax credits carryforwards | $6.20 |
Valuation_Allowance_Activity_o
Valuation Allowance Activity on Deferred Tax Assets (Detail) (USD $) | 12 Months Ended | ||
In Thousands, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Valuation Allowance [Line Items] | |||
Balance At End Of Period | $128,890 | $141,150 | |
Valuation Allowance of Deferred Tax Assets | |||
Valuation Allowance [Line Items] | |||
Balance At Beginning Of Period | 141,150 | 133,271 | 113,823 |
Additions Charged To Income Tax Expense | 27,893 | 22,998 | 28,102 |
Reductions Credited To Income Tax Expense | 40,153 | 15,119 | 8,654 |
Balance At End Of Period | $128,890 | $141,150 | $133,271 |
Assets_Measured_at_Fair_Value_
Assets Measured at Fair Value on Recurring Basis (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $68,921 | $65,586 |
Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | 30,618 | 31,566 |
Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale securities | $38,303 | $34,020 |
Summary_of_Restricted_Cash_Use
Summary of Restricted Cash Used to Collateralize Various Letters of Credit (Detail) (USD $) | Dec. 31, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Restricted cash, current | $530 | |
Restricted cash, non-current | 785 | 500 |
Office Lease | Rockville, Maryland | ||
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Restricted cash, current | 430 | |
Office Lease | Washington, D.C. | ||
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Restricted cash, non-current | 785 | 500 |
Board of Pharmacy license | Maryland | ||
Restricted Cash and Cash Equivalents Items [Line Items] | ||
Restricted cash, current | $100 |
Public_Offering_of_Common_Stoc1
Public Offering of Common Stock - Additional Information (Detail) (USD $) | 1 Months Ended | 12 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Oct. 31, 2014 | Aug. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 |
Stockholders Equity Note [Line Items] | ||||
Public common stock offering, shares | 5,750,000 | 4,680,000 | ||
Common stock offering price, per share | $11.60 | $11.14 | ||
Net cash proceeds from public common stock offering | $62,313 | $48,505 | $62,313 | $48,505 |
Equity_Incentive_Plans_Textual
Equity Incentive Plans (Textual 1 - Equity Incentive Plan) - Additional Information (Detail) | 12 Months Ended | |||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of equity incentive plans | 2 | |||
2004 Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Outstanding options granted | 652,810 | 670,744 | 672,145 | 677,145 |
2006 Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Outstanding options granted | 6,227,112 | 5,533,618 | 4,865,487 | 4,254,681 |
Common stock reserved for issuance | 10,329,472 | |||
2006 Plan | Outstanding options and RSUs granted (RSUs) | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Shares subject to outstanding options and RSUs | 7,253,073 | |||
Shares available for future grant | 956,265 | |||
2006 Plan | January 1, 2014 | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock reserved for issuance | 11,829,472 | |||
Increase each January 1 in the number of shares reserved under 2006 Plan as a percentage of common stock outstanding | 4.00% | |||
Minimum increase each January 1 in the number of shares reserved | 1,500,000 | |||
Increase in number of shares reserved and available for future grant | 1,500,000 |
Equity_Incentive_Plans_Textual1
Equity Incentive Plans (Textual 2 Stock Option) - Additional Information (Detail) (USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Share based compensation option awards contractual term | 10 years | ||
Portion of initial stock options granted to employees that vests on employee's first anniversary | 25.00% | ||
Portion of initial stock options granted to employees that vests ratably over three years after completion of first year of service | 75.00% | ||
Option awards vesting period, after completion of one year of service | 3 years | ||
Vesting period | 4 years | ||
Vesting period for initial stock options granted to directors | 4 years | ||
Vesting period for subsequent stock options granted to directors | 1 year | ||
Unrecognized compensation expenses, weighted average period | 2 years 2 months 12 days | ||
Proceeds from exercise of employee stock options | $2,851,000 | $1,550,000 | $12,000 |
Service option awards | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Unrecognized compensation expenses | $14,000,000 | ||
Unrecognized compensation expenses, weighted average period | 1 year 8 months 12 days | ||
2004 Plan | |||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | |||
Expected to vest at September 30, 2014 | 0 |
Summary_of_Option_Activity_for
Summary of Option Activity for 2004 Plan (Detail) (2004 Plan, USD $) | 12 Months Ended | |||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
2004 Plan | ||||
Number of Shares | ||||
Beginning balance | 670,744 | 672,145 | 677,145 | |
Exercised | -17,934 | -115 | -5,000 | |
Expired | -1,286 | |||
Ending balance | 652,810 | 670,744 | 672,145 | 677,145 |
Exercisable | 652,810 | |||
Weighted Average Exercise Price at Grant Date | ||||
Beginning balance | $1.79 | $1.79 | $1.78 | |
Exercised | $3.57 | $4.73 | $0.33 | |
Expired | $3.67 | |||
Ending balance | $1.74 | $1.79 | $1.79 | $1.78 |
Exercisable | $1.74 | |||
Weighted Average Remaining Term (Years) | ||||
Weighted Average Remaining Term | 9 months 11 days | 1 year 9 months 11 days | 2 years 9 months 11 days | 3 years 9 months 11 days |
Exercisable | 9 months 11 days | |||
Aggregate Intrinsic Value | ||||
Beginning balance | $7,124 | $1,512 | $2,016 | |
Exercised | 14 | |||
Ending balance | 8,212 | 7,124 | 1,512 | 2,016 |
Exercisable | $8,212 |
Summary_of_Option_Activity_for1
Summary of Option Activity for 2006 Plan (Detail) (2006 Plan, USD $) | 12 Months Ended | |||
In Thousands, except Share data, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | Dec. 31, 2011 |
2006 Plan | ||||
Number of Shares | ||||
Beginning balance | 5,533,618 | 4,865,487 | 4,254,681 | |
Granted | 1,324,337 | 1,245,500 | 846,000 | |
Forfeited | -237,108 | -54,226 | -149,091 | |
Expired | -259,295 | -76,103 | ||
Exercised | -393,735 | -263,848 | -10,000 | |
Ending balance | 6,227,112 | 5,533,618 | 4,865,487 | 4,254,681 |
Exercisable | 3,822,302 | |||
Expected to vest at December 31, 2014 | 2,263,369 | |||
Weighted Average Exercise Price at Grant Date | ||||
Beginning balance | $10.98 | $10.83 | $12.16 | |
Granted | $12.17 | $10.18 | $3.42 | |
Forfeited | $8.35 | $6.14 | $7.50 | |
Expired | $10.65 | $10.68 | ||
Exercised | $7.08 | $5.86 | $1.02 | |
Ending balance | $11.58 | $10.98 | $10.83 | $12.16 |
Exercisable | $12.31 | |||
Expected to vest at December 31, 2014 | $10.34 | |||
Weighted Average Remaining Term (Years) | ||||
Weighted Average Remaining Term | 6 years 8 months 16 days | 6 years 11 months 5 days | 7 years 1 month 24 days | 7 years 7 months 24 days |
Exercisable | 5 years 2 months 5 days | |||
Expected to vest at December 31, 2014 | 9 years 1 month 13 days | |||
Aggregate Intrinsic Value | ||||
Beginning balance | $21,264 | $634 | $396 | |
Exercised | 2,923 | 1,545 | 22 | |
Ending balance | 28,523 | 21,264 | 634 | 396 |
Exercisable | 19,110 | |||
Expected to vest at December 31, 2014 | $9,034 |
Equity_Incentive_Plans_Textual2
Equity Incentive Plans (Textual 3 RSU) - Additional Information (Detail) (USD $) | 12 Months Ended | |
Dec. 31, 2014 | Dec. 31, 2013 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Vesting period of RSU awards in equal installments | 4 years | |
Unrecognized compensation expenses, weighted average period | 2 years 2 months 12 days | |
Fair value of common stock vested | $1,400,000 | |
Common shares received in payment of payroll taxes (shares) | 32,386 | |
Tax obligations paid in connection with settlement of restricted stock units | 436,000 | 196,000 |
2006 Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Fair value of common stock vested, shares | 209,562 | 201,186 |
Restricted Stock Units (RSU) | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unrecognized compensation expenses related to unvested RSUs | $8,300,000 |
Summary_of_RSU_Activity_for_20
Summary of RSU Activity for 2006 Plan (Detail) (2006 Plan, USD $) | 12 Months Ended | ||
Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | |
2006 Plan | |||
Number of Shares Unvested | |||
Beginning balance | 883,690 | 705,376 | 522,346 |
Granted | 436,115 | 400,500 | 245,000 |
Forfeited | -84,282 | -21,000 | -61,970 |
Vested | -209,562 | -201,186 | |
Ending balance | 1,025,961 | 883,690 | 705,376 |
Weighted Average Price/Share Unvested | |||
Beginning balance | $7.70 | $5.91 | $7.43 |
Granted | $12.28 | $10.29 | $3.28 |
Forfeited | $6.75 | $6.41 | $7.64 |
Vested | $6.67 | $6.71 | |
Ending balance | $9.94 | $7.70 | $5.91 |
Employee_Benefit_Plan_Addition
Employee Benefit Plan - Additional Information (Detail) (USD $) | 12 Months Ended | ||
In Millions, unless otherwise specified | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Employee Benefit Plan [Line Items] | |||
Defined contribution plan employer matching percent | 50.00% | ||
Defined contribution plan maximum employee contribution percent | 6.00% | ||
Defined contribution plan vesting period | 4 years | ||
Defined contribution plan matching amount | $0.20 | $0.20 | $0.10 |
Legal_Matters_Additional_Infor
Legal Matters - Additional Information (Detail) (Fanapt) | 12 Months Ended |
Dec. 31, 2014 | |
Fanapt | |
Gain Contingencies [Line Items] | |
Patent expiration year | 2027 |
Quarterly_Financial_Data_Detai
Quarterly Financial Data (Detail) (USD $) | 3 Months Ended | 12 Months Ended | |||||||||||||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2013 | Sep. 30, 2013 | Jun. 30, 2013 | Mar. 31, 2013 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 | ||||
Quarterly Financial Data [Line Items] | |||||||||||||||
Revenue | $15,370 | $14,782 | $10,862 | $9,143 | $8,783 | [1] | $8,709 | [1] | $8,319 | [1] | $8,068 | [1] | $50,157 | $33,879 | $32,727 |
Income (loss) from operations | 69,693 | -1,448 | -21,606 | -26,578 | -7,791 | [1] | -5,431 | [1] | -3,413 | [1] | -4,565 | [1] | 20,062 | -21,200 | -29,178 |
Net income (loss) | $69,719 | ($1,426) | ($21,575) | ($26,533) | ($7,747) | [1] | ($5,406) | [1] | ($3,383) | [1] | ($4,519) | [1] | $20,186 | ($21,055) | ($28,617) |
Net income (loss) per share: | |||||||||||||||
Basic | $1.85 | ($0.04) | ($0.64) | ($0.79) | $0.58 | ($0.69) | ($1.01) | ||||||||
Diluted | $1.77 | ($0.04) | ($0.64) | ($0.79) | $0.55 | ($0.69) | ($1.01) | ||||||||
Net loss per share, basic and diluted | ($0.23) | [1] | ($0.17) | [1] | ($0.12) | [1] | ($0.16) | [1] | |||||||
[1] | In the first quarter of 2014, the Company elected to change its method of accounting for stock-based compensation from the accelerated attribution method to the straight-line method. The consolidated financial data above for the year ended 2013 has been adjusted to reflect this change. See Note 4, Change in Method of Accounting for Stock-based Compensation, for further discussion. |
Recovered_Sheet1
Quarterly Financial Data (Unaudited) - Additional Information (Detail) (USD $) | 3 Months Ended | 12 Months Ended | |||||
In Thousands, except Per Share data, unless otherwise specified | Dec. 31, 2014 | Sep. 30, 2014 | Jun. 30, 2014 | Mar. 31, 2014 | Dec. 31, 2014 | Dec. 31, 2013 | Dec. 31, 2012 |
Schedule Of Quarterly Financial Data [Line Items] | |||||||
Gain on arbitration settlement | $77,600 | $77,616 | |||||
Basic | $1.85 | ($0.04) | ($0.64) | ($0.79) | $0.58 | ($0.69) | ($1.01) |
Diluted | $1.77 | ($0.04) | ($0.64) | ($0.79) | $0.55 | ($0.69) | ($1.01) |
Arbitration | |||||||
Schedule Of Quarterly Financial Data [Line Items] | |||||||
Basic | $2.06 | ||||||
Diluted | $1.97 |