Document_and_Entity_Informatio
Document and Entity Information | 9 Months Ended | |
Sep. 30, 2014 | Oct. 22, 2014 | |
Document Information [Line Items] | ' | ' |
Document Type | '10-Q | ' |
Amendment Flag | 'false | ' |
Document Period End Date | 30-Sep-14 | ' |
Document Fiscal Year Focus | '2014 | ' |
Document Fiscal Period Focus | 'Q3 | ' |
Trading Symbol | 'VNDA | ' |
Entity Registrant Name | 'Vanda Pharmaceuticals Inc. | ' |
Entity Central Index Key | '0001347178 | ' |
Current Fiscal Year End Date | '--12-31 | ' |
Entity Filer Category | 'Accelerated Filer | ' |
Entity Common Stock, Shares Outstanding | ' | 33,901,084 |
CONDENSED_CONSOLIDATED_BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Current assets: | ' | ' |
Cash and cash equivalents | $15,308 | $64,764 |
Marketable securities | 40,781 | 65,586 |
Accounts receivable, net | 3,696 | 2,031 |
Inventory | 1,268 | ' |
Prepaid expenses and other current assets | 3,785 | 2,703 |
Restricted cash | ' | 530 |
Total current assets | 64,838 | 135,614 |
Property and equipment, net | 2,233 | 2,198 |
Intangible asset, net | 11,319 | 5,037 |
Restricted cash, non-current | 785 | 500 |
Total assets | 79,175 | 143,349 |
Current liabilities: | ' | ' |
Accounts payable | 547 | 661 |
Accrued liabilities | 6,825 | 5,180 |
Deferred rent | 241 | 221 |
Deferred revenues | 31,232 | 26,789 |
Total current liabilities | 38,845 | 32,851 |
Deferred rent, non-current | 2,919 | 2,888 |
Deferred revenues, non-current | 36,235 | 63,486 |
Other liabilities | 113 | ' |
Total liabilities | 78,112 | 99,225 |
Commitments and contingencies (Note 13) | ' | ' |
Stockholders' equity: | ' | ' |
Preferred stock, $0.001 par value; 20,000,000 shares authorized, and no shares issued or outstanding | 0 | ' |
Common stock, $0.001 par value; 150,000,000 shares authorized; 33,901,084 and 33,338,543 shares issued and outstanding at September 30, 2014 and December 31, 2013, respectively | 34 | 33 |
Additional paid-in capital | 358,728 | 352,240 |
Accumulated other comprehensive income | 4 | 21 |
Accumulated deficit | -357,703 | -308,170 |
Total stockholders' equity | 1,063 | 44,124 |
Total liabilities and stockholders' equity | $79,175 | $143,349 |
CONDENSED_CONSOLIDATED_BALANCE1
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) (USD $) | Sep. 30, 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 | 33,901,084 | 33,338,543 |
Common stock, shares outstanding | 33,901,084 | 33,338,543 |
CONDENSED_CONSOLIDATED_STATEME
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Revenues: | ' | ' | ' | ' |
Product revenue,net | $5,329 | ' | $6,888 | ' |
Royalty revenue | 1,689 | 1,956 | 4,919 | 5,059 |
Licensing agreement | 7,764 | 6,753 | 22,981 | 20,037 |
Total revenues | 14,782 | 8,709 | 34,788 | 25,096 |
Operating expenses: | ' | ' | ' | ' |
Cost of goods sold | 703 | ' | 901 | ' |
Research and development | 3,701 | 8,022 | 14,479 | 22,233 |
Selling, general and administrative | 11,290 | 5,741 | 67,321 | 15,154 |
Intangible asset amortization | 536 | 377 | 1,718 | 1,118 |
Total operating expenses | 16,230 | 14,140 | 84,419 | 38,505 |
Loss from operations | -1,448 | -5,431 | -49,631 | -13,409 |
Other income | 22 | 25 | 98 | 101 |
Net loss | ($1,426) | ($5,406) | ($49,533) | ($13,308) |
Basic and diluted net loss per share | ($0.04) | ($0.17) | ($1.46) | ($0.45) |
Weighted average shares outstanding, basic and diluted | 33,886,845 | 31,332,993 | 33,814,154 | 29,363,162 |
CONDENSED_CONSOLIDATED_STATEME1
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Net loss | ($1,426) | ($5,406) | ($49,533) | ($13,308) |
Other comprehensive income (loss): | ' | ' | ' | ' |
Change in net unrealized loss on marketable securities | -6 | ' | -17 | -10 |
Tax provision on other comprehensive income (loss) | ' | ' | ' | ' |
Other comprehensive loss, net of tax: | -6 | ' | -17 | -10 |
Comprehensive loss | ($1,432) | ($5,406) | ($49,550) | ($13,318) |
CONDENSED_CONSOLIDATED_STATEME2
CONDENSED CONSOLIDATED 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, 2013 (As Previously Reported) | $44,124 | $33 | $355,432 | $21 | ($311,362) |
Beginning balance (Retrospective Adjustment) | ' | ' | -3,192 | ' | 3,192 |
Beginning balance at Dec. 31, 2013 | 44,124 | 33 | 352,240 | 21 | -308,170 |
Beginning balance (in shares) at Dec. 31, 2013 (As Previously Reported) | ' | 33,338,543 | ' | ' | ' |
Beginning balance (in shares) at Dec. 31, 2013 | ' | 33,338,543 | ' | ' | ' |
Issuance of common stock from the exercise of stock options and settlement of restricted stock units (in shares) | ' | 594,927 | ' | ' | ' |
Issuance of common stock from the exercise of stock options and settlement of restricted stock units | 2,678 | 1 | 2,677 | ' | ' |
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 | 4,247 | ' | 4,247 | ' | ' |
Net loss | -49,533 | ' | ' | ' | -49,533 |
Other comprehensive income (loss), net of tax | -17 | ' | ' | -17 | ' |
Ending balance at Sep. 30, 2014 | $1,063 | $34 | $358,728 | $4 | ($357,703) |
Ending balance (in shares) at Sep. 30, 2014 | ' | 33,901,084 | ' | ' | ' |
CONDENSED_CONSOLIDATED_STATEME3
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 |
Cash flows from operating activities | ' | ' |
Net loss | ($49,533) | ($13,308) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' |
Depreciation and amortization of property and equipment | 396 | 321 |
Employee and non-employee stock-based compensation | 4,247 | 3,997 |
Amortization of discounts and premiums on marketable securities | 132 | 121 |
Intangible asset amortization | 1,718 | 1,118 |
Changes in assets and liabilities: | ' | ' |
Accounts receivable | -1,665 | -788 |
Prepaid expenses and other current assets | -1,082 | 1,555 |
Inventory | -1,268 | ' |
Accounts payable | -114 | 82 |
Accrued liabilities | 1,645 | -655 |
Other liabilities | 164 | 155 |
Deferred revenue | -22,808 | -20,037 |
Net cash used in operating activities | -68,168 | -27,439 |
Cash flows from investing activities | ' | ' |
Acquisition of intangible assets | -8,000 | ' |
Purchases of property and equipment | -431 | -79 |
Purchases of marketable securities | -40,383 | ' |
Proceeds from sale of marketable securities | 8,948 | ' |
Maturities of marketable securities | 56,092 | 31,500 |
Change in restricted cash | 245 | ' |
Net cash provided by investing activities | 16,471 | 31,421 |
Cash flows from financing activities | ' | ' |
Net proceeds from public offering of common stock | ' | 48,552 |
Tax obligations paid in connection with settlement of restricted stock units | -436 | -196 |
Proceeds from exercise of employee stock options | 2,677 | 1,062 |
Net cash provided by financing activities | 2,241 | 49,418 |
Net (decrease) increase in cash and cash equivalents | -49,456 | 53,400 |
Cash and cash equivalents | ' | ' |
Beginning of period | 64,764 | 88,772 |
End of period | $15,308 | $142,172 |
Business_Organization_and_Pres
Business Organization and Presentation | 9 Months Ended |
Sep. 30, 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. Vanda’s product portfolio includes 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 is being marketed and sold in the U.S. by Novartis Pharma AG (Novartis), launched in Israel by the Company’s distribution partners and expected to be launched in Mexico by the Company’s distribution partner in the fourth quarter of 2014, and VLY-686, a small molecule neurokinin-1 receptor (NK-1R) antagonist. | |
Basis of presentation | |
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s consolidated financial statements for the fiscal year ended December 31, 2013 included in the Company’s annual report on Form 10-K. The financial information as of September 30, 2014 and for the three and nine months ended September 30, 2014 and 2013 is unaudited, but in the opinion of management, all adjustments with the exception of stock-based compensation expense, see Note 3, Change in Method of Accounting for Stock-based Compensation, consist only of normal recurring accruals, considered necessary for a fair statement of the results of these interim periods have been included. The condensed consolidated balance sheet data as of December 31, 2013 was derived from audited financial statements but does not include all disclosures required by GAAP. | |
The results of the Company’s operations for any interim period are not necessarily indicative of the results that may be expected for any other interim period or for a full fiscal year. The financial information included herein should be read in conjunction with the consolidated financial statements and notes in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2013. |
Summary_of_Significant_Account
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2014 | |
Summary of Significant Accounting Policies | ' |
2. Summary of Significant Accounting Policies | |
Use of estimates | |
The preparation of financial statements in conformity with GAAP requires management to make estimates that affect the reported amounts of assets and liabilities at the date of the financial statements, disclosure of contingent assets and liabilities, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. | |
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. | |
Net Product Revenues | |
The Company’s 2014 net product revenues 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. In April 2014, the Company launched HETLIOZSolutions™ to support and facilitate the treatment of blind individuals in the U.S. living with Non-24. HETLIOZSolutions™ provides patients with a host of resources including information about Non-24 and HETLIOZ®, insurance support, overview of financial assistance programs and pharmacy access. 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, which is approximately 45-days following the end of the calendar quarter. As of September 30, 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 revenue 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. | |
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. Comparative financial statements for prior periods have been adjusted to apply the straight-line method retrospectively. See Note 3, Change in Method of Accounting for Stock-based Compensation, for further information. 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. | |
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 $0.3 million and $4.6 million for the three and nine months ended September 30, 2014, respectively. The Company did not incur any advertising expense during the nine months ended September 30, 2013. | |
Recent accounting pronouncements | |
In August 2014, the FASB issued Accounting Standard Update (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. | |
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. |
Change_in_Method_of_Accounting
Change in Method of Accounting for Stock-based Compensation | 9 Months Ended | ||||||||||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||||||||||
Change in Method of Accounting for Stock-based Compensation | ' | ||||||||||||||||||||||||
3. 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 restricted stock units (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 $0.4 million and $1.6 million lower than it would have been under the accelerated attribution method for the three and nine months ended September 30, 2014, respectively. This resulted in a reduction to the net loss of $0.4 million and $1.6 million, or $0.01 per share and $0.05 per share, respectively, for the three and nine months ended September 30, 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, 2013, the beginning of the earliest period presented in the financial statements was a reduction of $3.2 million. The adjustments as of December 31, 2013 were as follows: | |||||||||||||||||||||||||
Balance Sheet | December 31, 2013 | ||||||||||||||||||||||||
(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; 33,338,543 shares issued and outstanding at December 31, 2013 | $ | 33 | $ | — | $ | 33 | |||||||||||||||||||
Additional paid-in capital | 355,432 | (3,192 | ) | 352,240 | |||||||||||||||||||||
Accumulated other comprehensive income | 21 | — | 21 | ||||||||||||||||||||||
Accumulated deficit | (311,362 | ) | 3,192 | (308,170 | ) | ||||||||||||||||||||
Total stockholders’ equity | $ | 44,124 | $ | — | $ | 44,124 | |||||||||||||||||||
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 three and nine months ended September 30, 2013 were as follows: | |||||||||||||||||||||||||
Statement of Operations | Three Months Ended September 30, 2013 | Nine Months Ended September 30, 2013 | |||||||||||||||||||||||
(in thousands, except for share and per share amounts) | As previously | Retrospective | As | As previously | Retrospective | As | |||||||||||||||||||
Reported | Adjustment | Adjusted | Reported | Adjustment | Adjusted | ||||||||||||||||||||
Revenues: | |||||||||||||||||||||||||
Licensing agreement | $ | 6,753 | $ | — | $ | 6,753 | $ | 20,037 | $ | — | $ | 20,037 | |||||||||||||
Royalty revenue | 1,956 | — | 1,956 | 5,059 | — | 5,059 | |||||||||||||||||||
Total revenues | 8,709 | — | 8,709 | 25,096 | — | 25,096 | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||||
Research and development | 8,026 | (4 | ) | 8,022 | 21,968 | 265 | 22,233 | ||||||||||||||||||
Selling, general and administrative | 5,711 | 30 | 5,741 | 14,743 | 411 | 15,154 | |||||||||||||||||||
Intangible asset amortization | 377 | — | 377 | 1,118 | — | 1,118 | |||||||||||||||||||
Total operating expenses | 14,114 | 26 | 14,140 | 37,829 | 676 | 38,505 | |||||||||||||||||||
Loss from operations | (5,405 | ) | (26 | ) | (5,431 | ) | (12,733 | ) | (676 | ) | (13,409 | ) | |||||||||||||
Other income | 25 | — | 25 | 101 | — | 101 | |||||||||||||||||||
Loss before tax benefit | (5,380 | ) | (26 | ) | (5,406 | ) | (12,632 | ) | (676 | ) | (13,308 | ) | |||||||||||||
Tax benefit | — | — | — | — | — | — | |||||||||||||||||||
Net loss | $ | (5,380 | ) | $ | (26 | ) | $ | (5,406 | ) | $ | (12,632 | ) | $ | (676 | ) | $ | (13,308 | ) | |||||||
Basic and diluted net loss per share | $ | (0.17 | ) | $ | — | $ | (0.17 | ) | $ | (0.43 | ) | $ | (0.02 | ) | $ | (0.45 | ) | ||||||||
Weighted average shares outstanding, basic and diluted | 31,332,993 | — | 31,332,993 | 29,363,162 | — | 29,363,162 | |||||||||||||||||||
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 adjustment for the three and nine months ended September 30, 2013 was as follows: | |||||||||||||||||||||||||
Statement of Comprehensive Loss | Three Months Ended September 30, 2013 | Nine Months Ended September 30, 2013 | |||||||||||||||||||||||
(in thousands) | As Previously | Retrospective | As | As Previously | Retrospective | As | |||||||||||||||||||
Reported | Adjustment | Adjusted | Reported | Adjustment | Adjusted | ||||||||||||||||||||
Net loss | $ | (5,380 | ) | $ | (26 | ) | $ | (5,406 | ) | $ | (12,632 | ) | $ | (676 | ) | $ | (13,308 | ) | |||||||
Other comprehensive loss: | |||||||||||||||||||||||||
Change in net unrealized loss on marketable securities | — | — | — | (10 | ) | — | (10 | ) | |||||||||||||||||
Tax provision on other comprehensive income (loss) | — | — | — | — | — | — | |||||||||||||||||||
Other comprehensive loss, net of tax: | — | — | — | (10 | ) | — | (10 | ) | |||||||||||||||||
Comprehensive loss | $ | (5,380 | ) | $ | (26 | ) | $ | (5,406 | ) | $ | (12,642 | ) | $ | (676 | ) | $ | (13,318 | ) | |||||||
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 nine months ended September 30, 2013 were as follows: | |||||||||||||||||||||||||
Statement of Cash Flows | Nine Months Ended September 30, 2013 | ||||||||||||||||||||||||
(in thousands) | As Previously | Retrospective | As | ||||||||||||||||||||||
Reported | Adjustment | Adjusted | |||||||||||||||||||||||
Cash flows from operating activities | |||||||||||||||||||||||||
Net loss | $ | (12,632 | ) | $ | (676 | ) | $ | (13,308 | ) | ||||||||||||||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||||||||||||||||
Depreciation and amortization of property and equipment | 321 | — | 321 | ||||||||||||||||||||||
Employee and non-employee stock-based compensation | 3,321 | 676 | 3,997 | ||||||||||||||||||||||
Amortization of discounts and premiums on marketable securities | 121 | — | 121 | ||||||||||||||||||||||
Intangible asset amortization | 1,118 | — | 1,118 | ||||||||||||||||||||||
Changes in assets and liabilities, net | (19,688 | ) | — | (19,688 | ) | ||||||||||||||||||||
Net cash used in operating activities | $ | (27,439 | ) | $ | — | $ | (27,439 | ) | |||||||||||||||||
Earnings_per_Share
Earnings per Share | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Earnings per Share | ' | ||||||||||||||||
4. 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 loss per share of common stock for the three and nine months ended September 30, 2014 and 2013: | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
(in thousands, except for share and per share amounts) | September 30, | September 30, | September 30, | September 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Numerator: | |||||||||||||||||
Net loss | $ | (1,426 | ) | $ | (5,406 | ) | $ | (49,533 | ) | $ | (13,308 | ) | |||||
Denominator: | |||||||||||||||||
Weighted average shares outstanding, basic and diluted | 33,886,845 | 31,332,993 | 33,814,154 | 29,363,162 | |||||||||||||
Net loss per share, basic and diluted: | |||||||||||||||||
Net loss per share | $ | (0.04 | ) | $ | (0.17 | ) | $ | (1.46 | ) | $ | (0.45 | ) | |||||
Antidilutive securities excluded from calculations of diluted net loss per share | 3,728,109 | 3,517,934 | 3,779,497 | 4,504,339 | |||||||||||||
The Company incurred net losses for the three and nine months ended September 30, 2014 and 2013 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 | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Marketable Securities | ' | ||||||||||||||||
5. Marketable Securities | |||||||||||||||||
The following is a summary of the Company’s available-for-sale marketable securities as of September 30, 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 | $ | 15,215 | $ | 2 | $ | (1 | ) | $ | 15,216 | ||||||||
Corporate debt | $ | 25,562 | $ | 6 | $ | (3 | ) | $ | 25,565 | ||||||||
$ | 40,777 | $ | 8 | $ | (4 | ) | $ | 40,781 | |||||||||
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 | |||||||||
Fair_Value_Measurements
Fair Value Measurements | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Fair Value Measurements | ' | ||||||||||||||||
6. 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 as of September 30, 2014 and December 31, 2013 consist of 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 and corporate notes that use as their basis readily observable market parameters. The Company did not transfer any assets between Level 2 and Level 1 during the nine months ended September 30, 2014. | |||||||||||||||||
As of September 30, 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 September 30, 2014 Using | |||||||||||||||||
(in thousands) | September 30, | 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 | $ | 40,781 | $ | 15,216 | $ | 25,565 | $ | — | |||||||||
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. |
Inventory
Inventory | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Inventory | ' | ||||||||
7. 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 September 30, 2014 and December 31, 2013: | |||||||||
(in thousands) | September 30, | December 31, | |||||||
2014 | 2013 | ||||||||
Raw materials | $ | 213 | $ | — | |||||
Work-in-process | 7 | — | |||||||
Finished goods | 796 | — | |||||||
Deferred cost of goods sold | 252 | — | |||||||
Total | $ | 1,268 | $ | — | |||||
Deferred cost of goods sold represents the cost of product shipped to Probiomed, for which revenue recognition has been deferred. See Note 2, Summary of Significant Accounting Policies, for a discussion of Fanapt® revenue recognition. |
Prepaid_Expenses_and_Other_Cur
Prepaid Expenses and Other Current Assets | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Prepaid Expenses and Other Current Assets | ' | ||||||||
8. Prepaid Expenses and Other Current Assets | |||||||||
The following is a summary of the Company’s prepaid expenses and other current assets as of September 30, 2014 and December 31, 2013: | |||||||||
(in thousands) | September 30, | December 31, | |||||||
2014 | 2013 | ||||||||
Prepaid insurance | $ | 487 | $ | 167 | |||||
Prepaid manufacturing cost | 608 | — | |||||||
Other prepaid expenses and vendor advances | 2,508 | 2,408 | |||||||
Other current assets | 182 | 128 | |||||||
Total prepaid expenses and other current assets | $ | 3,785 | $ | 2,703 | |||||
Intangible_Assets
Intangible Assets | 9 Months Ended | ||||||||||||||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||||||||||||||
Intangible Assets | ' | ||||||||||||||||||||||||||||
9. Intangible Assets | |||||||||||||||||||||||||||||
The following is a summary of the Company’s intangible asset as of September 30, 2014: | |||||||||||||||||||||||||||||
September 30, 2014 | |||||||||||||||||||||||||||||
(in thousands) | Estimated | Gross | Accumulated | Net | |||||||||||||||||||||||||
Useful Life | Carrying | Amortization | Carrying | ||||||||||||||||||||||||||
(Years) | Amount | Amount | |||||||||||||||||||||||||||
HETLIOZ® | 19 | $ | 8,000 | $ | 436 | $ | 7,564 | ||||||||||||||||||||||
Fanapt® | 7.5 | $ | 12,000 | $ | 8,245 | $ | 3,755 | ||||||||||||||||||||||
The following is a summary of the Company’s intangible asset as of December 31, 2013: | |||||||||||||||||||||||||||||
December 31, 2013 | |||||||||||||||||||||||||||||
(in thousands) | Estimated | Gross | Accumulated | Net | |||||||||||||||||||||||||
Useful Life | Carrying | Amortization | Carrying | ||||||||||||||||||||||||||
(Years) | Amount | Amount | |||||||||||||||||||||||||||
Fanapt® | 8 | $ | 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. In 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. | |||||||||||||||||||||||||||||
The intangible assets are being amortized over their estimated useful economic life using the straight-line method. Amortization expense was $0.5 million and $0.4 million for the three months ended September 30, 2014 and 2013, respectively. Amortization expense was $1.7 million and $1.1 million for the nine months ended September 30, 2014 and 2013, respectively. The following is a summary of future intangible asset amortization as of September 30, 2014: | |||||||||||||||||||||||||||||
(in thousands) | Total | Remainder | 2015 | 2016 | 2017 | 2018 | Thereafter | ||||||||||||||||||||||
of 2014 | |||||||||||||||||||||||||||||
HETLIOZ® | $ | 7,564 | $ | 102 | $ | 411 | $ | 411 | $ | 411 | $ | 411 | $ | 5,818 | |||||||||||||||
Fanapt® | 3,755 | 433 | 1,733 | 1,589 | — | — | — | ||||||||||||||||||||||
$ | 11,319 | $ | 535 | $ | 2,144 | $ | 2,000 | $ | 411 | $ | 411 | $ | 5,818 | ||||||||||||||||
Accrued_Liabilities
Accrued Liabilities | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Accrued Liabilities | ' | ||||||||
10. Accrued Liabilities | |||||||||
The following is a summary of the Company’s accrued liabilities as of September 30, 2014 and December 31, 2013: | |||||||||
(in thousands) | September 30, | December 31, | |||||||
2014 | 2013 | ||||||||
Accrued research and development expenses | $ | 1,521 | $ | 2,324 | |||||
Accrued consulting and other professional fees | 2,454 | 2,015 | |||||||
Compensation and employee benefits | 1,593 | 176 | |||||||
Other accrued liabilities | 1,257 | 665 | |||||||
$ | 6,825 | $ | 5,180 | ||||||
Deferred_Revenue
Deferred Revenue | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Deferred Revenue | ' | ||||||||
11. Deferred Revenue | |||||||||
The following is a summary of changes in total deferred revenue for the nine months ended September 30, 2014 and 2013: | |||||||||
Nine Months Ended | |||||||||
(in thousands) | September 30, | September 30, | |||||||
2014 | 2013 | ||||||||
Balance beginning of period | $ | 90,275 | $ | 117,064 | |||||
Deferred Fanapt® product revenue | 173 | — | |||||||
Licensing revenue recognized | 22,981 | 20,037 | |||||||
Balance end of period | $ | 67,467 | $ | 97,027 | |||||
The Company entered into an amended and restated sublicense agreement with Novartis in 2009, pursuant to which Novartis has the right to commercialize and develop Fanapt® in the U.S. and Canada. Under the amended and restated sublicense agreement, 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 has no term as the exact length of the JSC is undefined. As a result, the Company deems the performance period of the JSC to be the life of the U.S. patent of Fanapt®. Revenue related to the upfront payment will be recognized ratably from the date the amended and restated sublicense agreement became effective (November 2009) through the expected life of the U.S. patent for Fanapt® (November 2016). See Note 9 Intangible Assets, for a discussion of the Fanapt® patent life. |
Income_Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2014 | |
Income Taxes | ' |
12. Income Taxes | |
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 September 30, 2014 and December 31, 2013. Changes in ownership may limit the amount of NOL carryforwards that can be utilized in the future to offset taxable income. |
Commitments_and_Contingencies
Commitments and Contingencies | 9 Months Ended | ||||||||||||||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||||||||||||||
Commitments and Contingencies | ' | ||||||||||||||||||||||||||||
13. Commitments and Contingencies | |||||||||||||||||||||||||||||
Operating leases | |||||||||||||||||||||||||||||
In 2011, the Company entered into an office lease with Square 54 Office Owner LLC (the Landlord) for its current headquarters, consisting of 21,400 square feet at 2200 Pennsylvania Avenue, N.W. in Washington, D.C. (the Lease). 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 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. | |||||||||||||||||||||||||||||
The following is a summary of the minimum annual future payments under operating leases as of September 30, 2014: | |||||||||||||||||||||||||||||
(in thousands) | Total | Remainder | 2015 | 2016 | 2017 | 2018 | Thereafter | ||||||||||||||||||||||
of 2014 | |||||||||||||||||||||||||||||
Operating leases | $ | 14,974 | $ | 323 | $ | 1,337 | $ | 1,500 | $ | 1,538 | $ | 1,576 | $ | 8,700 | |||||||||||||||
Rent expense under operating leases, was $0.4 million and $0.3 million for the three months ended September 30, 2014 and 2013, respectively. Rent expense under operating leases, was $1.2 million and $0.8 million for the nine months ended September 30, 2014 and 2013, 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, which is included in research and development expenses in the consolidated statement of operations for the nine months ended September 30, 2014. In March 2014, the Company terminated the engagement. | |||||||||||||||||||||||||||||
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 BMS under which the Company received an exclusive worldwide license under certain patents and patent applications, and other licenses to intellectual property, to develop and commercialize HETLIOZ®. As a result of the FDA approval of the NDA for HETLIOZ® in January 2014, the Company made a milestone payment of $8.0 million in the first quarter of 2014. The Company will be obligated to make a future milestone payment to BMS of up to $25.0 million in the event that cumulative worldwide sales of HETLIOZ® reach $250.0 million. Additionally, the Company will be obligated to make royalty payments equal to 10% of net sales of HETLIOZ®. 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 the Company receives from a third party in connection with any sublicensing arrangement, at a rate which is in the mid-twenties. Under the license agreement with BMS for HETLIOZ®, the Company is obligated to use commercially reasonable efforts to develop and commercialize HETLIOZ® and to meet certain milestones in initiating and completing certain clinical work. | |||||||||||||||||||||||||||||
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®. The Company acquired exclusive worldwide rights to patents and patent applications for Fanapt® in 2004 through a sublicense agreement with Novartis. 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 the Company to make a payment of $12.0 million to Novartis. | |||||||||||||||||||||||||||||
In 2009, the Company entered into an amended and restated sublicense agreement with Novartis, which amended and restated the 2004 sublicense agreement. Pursuant to the amended and restated sublicense agreement, the Company received an upfront payment of $200.0 million and is 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. Based on the current sales performance of Fanapt® in the U.S., the Company expects that some or all of these commercial and development milestones will not be achieved by Novartis. The Company also receives royalties, which, as a percentage of net sales, are in the low double-digits, on net sales of Fanapt® in the U.S. and Canada. | |||||||||||||||||||||||||||||
The Company retains exclusive rights to Fanapt® outside the U.S. and Canada, and the Company has exclusive rights to use any of Novartis’ data for Fanapt® for developing and commercializing Fanapt® outside the U.S. and Canada. Novartis has chosen not to co-commercialize Fanapt® with the Company in Europe and certain other countries. These include, but are not limited to, the countries in the European Union as well as Switzerland, Norway, Liechtenstein and Iceland. The Company will be obligated to make royalty payments based on the net sales of Fanapt® to either Novartis or Sanofi S.A depending on the jurisdiction where the sales occurred. At this time, the Company is only obligated to make a royalty payment to Sanofi S.A. The Company has entered into agreements with the following partners for the commercialization of Fanapt® in the countries set forth below: | |||||||||||||||||||||||||||||
Country | Partner | ||||||||||||||||||||||||||||
Mexico | Probiomed S.A. de C.V. | ||||||||||||||||||||||||||||
Israel | Megapharm Ltd. | ||||||||||||||||||||||||||||
In 2012, the Israeli Ministry of Health granted market approval for Fanapt® for the treatment of schizophrenia. In October 2013, the Mexican Federal Commission for Protection Against Sanitary Risks (COFEPRIS) granted market approval for Fanapt® for the treatment of schizophrenia. | |||||||||||||||||||||||||||||
VLY-686. In 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, VLY-686, for all human indications. The patent describing VLY-686 as a new chemical entity expires in April 2023, except in the U.S., where it expires in June 2024 absent any applicable patent term adjustments. | |||||||||||||||||||||||||||||
Pursuant to the license agreement, the Company will be responsible for all development costs, and Lilly is eligible to receive 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. The Company is obligated to use its commercially reasonable efforts to develop and commercialize VLY-686. | |||||||||||||||||||||||||||||
Either party may terminate the license agreement under certain circumstances, including a material breach of the license agreement by the other. In the event the Company terminates the license agreement, or if Lilly terminates due to the Company’s breach or for certain other reasons set forth in the license agreement, all rights licensed and developed by the Company 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 VLY-686. | |||||||||||||||||||||||||||||
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 September 30, 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. |
Legal_Matters
Legal Matters | 9 Months Ended |
Sep. 30, 2014 | |
Legal Matters | ' |
14. Legal Matters | |
In May 2014, the Company commenced arbitration proceedings with Novartis relating to the license of Fanapt®. The Company has requested an award of approximately $539.0 million in such proceedings. The Company is vigorously prosecuting its claims in the arbitration as well as defending counterclaims brought by Novartis for approximately $75.0 million, against which the Company believes it has meritorious defenses. The Company does not anticipate that this proceeding will have a material adverse effect on its business, results of operations or financial condition. While it is not possible to accurately predict or determine the eventual outcome of this matter, these proceedings are subject to inherent uncertainties and the Company may not prevail. The Company currently anticipates that the arbitration proceeding will be completed in mid to late 2015. | |
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. |
Employee_StockBased_Compensati
Employee Stock-Based Compensation | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Employee Stock-Based Compensation | ' | ||||||||||||||||
15. 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 from the accelerated attribution method to the straight-line method. See Note 3, Change in Method of Accounting for Stock-based Compensation for additional discussion. The fair value of stock options granted and RSUs awarded are amortized using the straight-line method. As stock-based compensation expense recognized in the consolidated statements of operations is based on awards ultimately expected to vest, it has been reduced for estimated forfeitures. Forfeitures are required to be estimated at the time of grant and revised, if necessary, in subsequent periods if actual forfeitures differ from those estimates. | |||||||||||||||||
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 nine months ended September 30, 2014 and 2013 were as follows: | |||||||||||||||||
Nine Months Ended | |||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2014 | 2013 | ||||||||||||||||
Expected dividend yield | 0 | % | 0 | % | |||||||||||||
Weighted average expected volatility | 64 | % | 63 | % | |||||||||||||
Weighted average expected term (years) | 5.84 | 6.03 | |||||||||||||||
Weighted average risk-free rate | 1.76 | % | 1.28 | % | |||||||||||||
Weighted average fair value per share | $ | 7.14 | $ | 3.98 | |||||||||||||
Total employee stock-based compensation expense related to stock-based awards for the three and nine months ended September 30, 2014 and 2013 was comprised of the following: | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
(in thousands) | September 30, | September 30, | September 30, | September 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Research and development | $ | 423 | $ | 415 | $ | 1,283 | $ | 1,473 | |||||||||
Selling, general and administrative | 969 | 1,121 | 2,870 | 2,474 | |||||||||||||
$ | 1,392 | $ | 1,536 | $ | 4,153 | $ | 3,947 | ||||||||||
As of September 30, 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). There were 652,810 shares subject to outstanding options granted under the 2004 Plan as of September 30, 2014, and no additional options will be granted under this plan. As of September 30, 2014, there were 10,329,472 shares of common stock reserved for issuance under the 2006 Plan, of which 5,854,567 shares were subject to outstanding options and RSUs granted to employees and non-employees and 2,381,075 shares remained available for future grant. | |||||||||||||||||
The Company has granted option awards with service conditions 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 2007, 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 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 September 30, 2014, there was $7.7 million of unrecognized compensation costs related to unvested service option awards expected to be recognized over a weighted average period of 1.5 years. No service option awards are classified as a liability as of September 30, 2014. | |||||||||||||||||
A summary of option activity for the 2004 Plan for the nine months ended September 30, 2014 follows: | |||||||||||||||||
(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, 2013 | 670,744 | $ | 1.79 | 1.78 | $ | 7,124 | |||||||||||
Expired | — | ||||||||||||||||
Exercised | (17,934 | ) | |||||||||||||||
Outstanding at September 30, 2014 | 652,810 | 1.74 | 1.03 | 5,640 | |||||||||||||
Exercisable at September 30, 2014 | 652,810 | 1.74 | 1.03 | 5,640 | |||||||||||||
There are no options expected to vest as of September 30, 2014 under the 2004 Plan, given that the Company stopped issuing options from this plan in 2006. | |||||||||||||||||
A summary of option activity for the 2006 Plan for the nine months ended September 30, 2014 follows: | |||||||||||||||||
(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, 2013 | 5,533,618 | $ | 10.98 | 6.93 | $ | 21,264 | |||||||||||
Granted | 259,000 | 12.22 | |||||||||||||||
Forfeited | (232,966 | ) | 8.33 | ||||||||||||||
Expired | — | ||||||||||||||||
Exercised | (367,431 | ) | 7.11 | 2,777 | |||||||||||||
Outstanding at September 30, 2014 | 5,192,221 | 11.43 | 6.31 | 11,814 | |||||||||||||
Exercisable at September 30, 2014 | 3,655,287 | 12.49 | 5.3 | 8,274 | |||||||||||||
Expected to vest at September 30, 2014 | 1,476,376 | 8.86 | 8.71 | 3,467 | |||||||||||||
Proceeds from the exercise of stock options amounted to $2.7 million for the nine months ended September 30, 2014. | |||||||||||||||||
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 that vest in four equal annual installments provided that the employee remains employed with the Company. As of September 30, 2014, there was $4.4 million of unrecognized compensation costs related to unvested RSUs expected to be recognized over a weighted average period of 1.9 years. No RSUs are classified as a liability as of September 30, 2014. | |||||||||||||||||
A summary of RSU activity for the 2006 Plan for the nine months ended September 30, 2014 follows: | |||||||||||||||||
Number of | Weighted | ||||||||||||||||
Shares | Average | ||||||||||||||||
Underlying | Grant Date | ||||||||||||||||
RSUs | Fair Value | ||||||||||||||||
Unvested at December 31, 2013 | 883,690 | $ | 7.7 | ||||||||||||||
Granted | 70,500 | 13.14 | |||||||||||||||
Forfeited | (82,282 | ) | 6.69 | ||||||||||||||
Vested | (209,562 | ) | 6.67 | ||||||||||||||
Unvested at September 30, 2014 | 662,346 | 8.74 | |||||||||||||||
The grant date fair value for the 209,562 shares underlying RSUs that vested during the nine months ended September 30, 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 nine months ended September 30, 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. |
Business_Organization_and_Pres1
Business Organization and Presentation (Policies) | 9 Months Ended |
Sep. 30, 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. Vanda’s product portfolio includes 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 is being marketed and sold in the U.S. by Novartis Pharma AG (Novartis), launched in Israel by the Company’s distribution partners and expected to be launched in Mexico by the Company’s distribution partner in the fourth quarter of 2014, and VLY-686, a small molecule neurokinin-1 receptor (NK-1R) antagonist. | |
Basis of presentation | ' |
Basis of presentation | |
The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all the information and footnotes required by GAAP for complete financial statements and should be read in conjunction with the Company’s consolidated financial statements for the fiscal year ended December 31, 2013 included in the Company’s annual report on Form 10-K. The financial information as of September 30, 2014 and for the three and nine months ended September 30, 2014 and 2013 is unaudited, but in the opinion of management, all adjustments with the exception of stock-based compensation expense, see Note 3, Change in Method of Accounting for Stock-based Compensation, consist only of normal recurring accruals, considered necessary for a fair statement of the results of these interim periods have been included. The condensed consolidated balance sheet data as of December 31, 2013 was derived from audited financial statements but does not include all disclosures required by GAAP. | |
The results of the Company’s operations for any interim period are not necessarily indicative of the results that may be expected for any other interim period or for a full fiscal year. The financial information included herein should be read in conjunction with the consolidated financial statements and notes in the Company’s annual report on Form 10-K for the fiscal year ended December 31, 2013. | |
Use of estimates | ' |
Use of estimates | |
The preparation of financial statements in conformity with GAAP requires management to make estimates that affect the reported amounts of assets and liabilities at the date of the financial statements, disclosure of contingent assets and liabilities, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. | |
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. | |
Net Product Revenues | ' |
Net Product Revenues | |
The Company’s 2014 net product revenues 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. In April 2014, the Company launched HETLIOZSolutions™ to support and facilitate the treatment of blind individuals in the U.S. living with Non-24. HETLIOZSolutions™ provides patients with a host of resources including information about Non-24 and HETLIOZ®, insurance support, overview of financial assistance programs and pharmacy access. 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, which is approximately 45-days following the end of the calendar quarter. As of September 30, 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 revenue 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. | |
Stock-based Compensation | ' |
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. Comparative financial statements for prior periods have been adjusted to apply the straight-line method retrospectively. See Note 3, Change in Method of Accounting for Stock-based Compensation, for further information. 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. | |
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 $0.3 million and $4.6 million for the three and nine months ended September 30, 2014, respectively. The Company did not incur any advertising expense during the nine months ended September 30, 2013. | |
Recent accounting pronouncements | ' |
Recent accounting pronouncements | |
In August 2014, the FASB issued Accounting Standard Update (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. | |
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. |
Change_in_Method_of_Accounting1
Change in Method of Accounting for Stock-based Compensation (Tables) | 9 Months Ended | ||||||||||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||||||||||
Adjustments in Balance Sheet | ' | ||||||||||||||||||||||||
The adjustments as of December 31, 2013 were as follows: | |||||||||||||||||||||||||
Balance Sheet | December 31, 2013 | ||||||||||||||||||||||||
(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; 33,338,543 shares issued and outstanding at December 31, 2013 | $ | 33 | $ | — | $ | 33 | |||||||||||||||||||
Additional paid-in capital | 355,432 | (3,192 | ) | 352,240 | |||||||||||||||||||||
Accumulated other comprehensive income | 21 | — | 21 | ||||||||||||||||||||||
Accumulated deficit | (311,362 | ) | 3,192 | (308,170 | ) | ||||||||||||||||||||
Total stockholders’ equity | $ | 44,124 | $ | — | $ | 44,124 | |||||||||||||||||||
Adjustments in Statement of Operations | ' | ||||||||||||||||||||||||
The adjustments for the three and nine months ended September 30, 2013 were as follows: | |||||||||||||||||||||||||
Statement of Operations | Three Months Ended September 30, 2013 | Nine Months Ended September 30, 2013 | |||||||||||||||||||||||
(in thousands, except for share and per share amounts) | As previously | Retrospective | As | As previously | Retrospective | As | |||||||||||||||||||
Reported | Adjustment | Adjusted | Reported | Adjustment | Adjusted | ||||||||||||||||||||
Revenues: | |||||||||||||||||||||||||
Licensing agreement | $ | 6,753 | $ | — | $ | 6,753 | $ | 20,037 | $ | — | $ | 20,037 | |||||||||||||
Royalty revenue | 1,956 | — | 1,956 | 5,059 | — | 5,059 | |||||||||||||||||||
Total revenues | 8,709 | — | 8,709 | 25,096 | — | 25,096 | |||||||||||||||||||
Operating expenses: | |||||||||||||||||||||||||
Research and development | 8,026 | (4 | ) | 8,022 | 21,968 | 265 | 22,233 | ||||||||||||||||||
Selling, general and administrative | 5,711 | 30 | 5,741 | 14,743 | 411 | 15,154 | |||||||||||||||||||
Intangible asset amortization | 377 | — | 377 | 1,118 | — | 1,118 | |||||||||||||||||||
Total operating expenses | 14,114 | 26 | 14,140 | 37,829 | 676 | 38,505 | |||||||||||||||||||
Loss from operations | (5,405 | ) | (26 | ) | (5,431 | ) | (12,733 | ) | (676 | ) | (13,409 | ) | |||||||||||||
Other income | 25 | — | 25 | 101 | — | 101 | |||||||||||||||||||
Loss before tax benefit | (5,380 | ) | (26 | ) | (5,406 | ) | (12,632 | ) | (676 | ) | (13,308 | ) | |||||||||||||
Tax benefit | — | — | — | — | — | — | |||||||||||||||||||
Net loss | $ | (5,380 | ) | $ | (26 | ) | $ | (5,406 | ) | $ | (12,632 | ) | $ | (676 | ) | $ | (13,308 | ) | |||||||
Basic and diluted net loss per share | $ | (0.17 | ) | $ | — | $ | (0.17 | ) | $ | (0.43 | ) | $ | (0.02 | ) | $ | (0.45 | ) | ||||||||
Weighted average shares outstanding, basic and diluted | 31,332,993 | — | 31,332,993 | 29,363,162 | — | 29,363,162 | |||||||||||||||||||
Adjustments in Statement of Comprehensive Loss | ' | ||||||||||||||||||||||||
The adjustment for the three and nine months ended September 30, 2013 was as follows: | |||||||||||||||||||||||||
Statement of Comprehensive Loss | Three Months Ended September 30, 2013 | Nine Months Ended September 30, 2013 | |||||||||||||||||||||||
(in thousands) | As Previously | Retrospective | As | As Previously | Retrospective | As | |||||||||||||||||||
Reported | Adjustment | Adjusted | Reported | Adjustment | Adjusted | ||||||||||||||||||||
Net loss | $ | (5,380 | ) | $ | (26 | ) | $ | (5,406 | ) | $ | (12,632 | ) | $ | (676 | ) | $ | (13,308 | ) | |||||||
Other comprehensive loss: | |||||||||||||||||||||||||
Change in net unrealized loss on marketable securities | — | — | — | (10 | ) | — | (10 | ) | |||||||||||||||||
Tax provision on other comprehensive income (loss) | — | — | — | — | — | — | |||||||||||||||||||
Other comprehensive loss, net of tax: | — | — | — | (10 | ) | — | (10 | ) | |||||||||||||||||
Comprehensive loss | $ | (5,380 | ) | $ | (26 | ) | $ | (5,406 | ) | $ | (12,642 | ) | $ | (676 | ) | $ | (13,318 | ) | |||||||
Adjustments in Statement of Cash Flows | ' | ||||||||||||||||||||||||
The adjustments for the nine months ended September 30, 2013 were as follows: | |||||||||||||||||||||||||
Statement of Cash Flows | Nine Months Ended September 30, 2013 | ||||||||||||||||||||||||
(in thousands) | As Previously | Retrospective | As | ||||||||||||||||||||||
Reported | Adjustment | Adjusted | |||||||||||||||||||||||
Cash flows from operating activities | |||||||||||||||||||||||||
Net loss | $ | (12,632 | ) | $ | (676 | ) | $ | (13,308 | ) | ||||||||||||||||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||||||||||||||||||
Depreciation and amortization of property and equipment | 321 | — | 321 | ||||||||||||||||||||||
Employee and non-employee stock-based compensation | 3,321 | 676 | 3,997 | ||||||||||||||||||||||
Amortization of discounts and premiums on marketable securities | 121 | — | 121 | ||||||||||||||||||||||
Intangible asset amortization | 1,118 | — | 1,118 | ||||||||||||||||||||||
Changes in assets and liabilities, net | (19,688 | ) | — | (19,688 | ) | ||||||||||||||||||||
Net cash used in operating activities | $ | (27,439 | ) | $ | — | $ | (27,439 | ) | |||||||||||||||||
Earnings_per_Share_Tables
Earnings per Share (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Basic and Diluted Net Loss Per Share of Common Stock | ' | ||||||||||||||||
The following table presents the calculation of basic and diluted net loss per share of common stock for the three and nine months ended September 30, 2014 and 2013: | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
(in thousands, except for share and per share amounts) | September 30, | September 30, | September 30, | September 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Numerator: | |||||||||||||||||
Net loss | $ | (1,426 | ) | $ | (5,406 | ) | $ | (49,533 | ) | $ | (13,308 | ) | |||||
Denominator: | |||||||||||||||||
Weighted average shares outstanding, basic and diluted | 33,886,845 | 31,332,993 | 33,814,154 | 29,363,162 | |||||||||||||
Net loss per share, basic and diluted: | |||||||||||||||||
Net loss per share | $ | (0.04 | ) | $ | (0.17 | ) | $ | (1.46 | ) | $ | (0.45 | ) | |||||
Antidilutive securities excluded from calculations of diluted net loss per share | 3,728,109 | 3,517,934 | 3,779,497 | 4,504,339 | |||||||||||||
Marketable_Securities_Tables
Marketable Securities (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Summary of Available-for-Sale Marketable Securities | ' | ||||||||||||||||
The following is a summary of the Company’s available-for-sale marketable securities as of September 30, 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 | $ | 15,215 | $ | 2 | $ | (1 | ) | $ | 15,216 | ||||||||
Corporate debt | $ | 25,562 | $ | 6 | $ | (3 | ) | $ | 25,565 | ||||||||
$ | 40,777 | $ | 8 | $ | (4 | ) | $ | 40,781 | |||||||||
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 | |||||||||
Fair_Value_Measurements_Tables
Fair Value Measurements (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
Assets Measured at Fair Value on Recurring Basis | ' | ||||||||||||||||
As of September 30, 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 September 30, 2014 Using | |||||||||||||||||
(in thousands) | September 30, | 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 | $ | 40,781 | $ | 15,216 | $ | 25,565 | $ | — | |||||||||
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 | $ | — |
Inventory_Tables
Inventory (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Inventory | ' | ||||||||
Inventory consisted of the following as of September 30, 2014 and December 31, 2013: | |||||||||
(in thousands) | September 30, | December 31, | |||||||
2014 | 2013 | ||||||||
Raw materials | $ | 213 | $ | — | |||||
Work-in-process | 7 | — | |||||||
Finished goods | 796 | — | |||||||
Deferred cost of goods sold | 252 | — | |||||||
Total | $ | 1,268 | $ | — | |||||
Prepaid_Expenses_and_Other_Cur1
Prepaid Expenses and Other Current Assets (Tables) | 9 Months Ended | ||||||||
Sep. 30, 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 September 30, 2014 and December 31, 2013: | |||||||||
(in thousands) | September 30, | December 31, | |||||||
2014 | 2013 | ||||||||
Prepaid insurance | $ | 487 | $ | 167 | |||||
Prepaid manufacturing cost | 608 | — | |||||||
Other prepaid expenses and vendor advances | 2,508 | 2,408 | |||||||
Other current assets | 182 | 128 | |||||||
Total prepaid expenses and other current assets | $ | 3,785 | $ | 2,703 | |||||
Intangible_Assets_Tables
Intangible Assets (Tables) | 9 Months Ended | ||||||||||||||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||||||||||||||
Summary of Intangible Asset | ' | ||||||||||||||||||||||||||||
The following is a summary of the Company’s intangible asset as of September 30, 2014: | |||||||||||||||||||||||||||||
September 30, 2014 | |||||||||||||||||||||||||||||
(in thousands) | Estimated | Gross | Accumulated | Net | |||||||||||||||||||||||||
Useful Life | Carrying | Amortization | Carrying | ||||||||||||||||||||||||||
(Years) | Amount | Amount | |||||||||||||||||||||||||||
HETLIOZ® | 19 | $ | 8,000 | $ | 436 | $ | 7,564 | ||||||||||||||||||||||
Fanapt® | 7.5 | $ | 12,000 | $ | 8,245 | $ | 3,755 | ||||||||||||||||||||||
The following is a summary of the Company’s intangible asset as of December 31, 2013: | |||||||||||||||||||||||||||||
December 31, 2013 | |||||||||||||||||||||||||||||
(in thousands) | Estimated | Gross | Accumulated | Net | |||||||||||||||||||||||||
Useful Life | Carrying | Amortization | Carrying | ||||||||||||||||||||||||||
(Years) | Amount | Amount | |||||||||||||||||||||||||||
Fanapt® | 8 | $ | 12,000 | $ | 6,963 | $ | 5,037 | ||||||||||||||||||||||
Summary of Future Intangible Asset Amortization | ' | ||||||||||||||||||||||||||||
The following is a summary of future intangible asset amortization as of September 30, 2014: | |||||||||||||||||||||||||||||
(in thousands) | Total | Remainder | 2015 | 2016 | 2017 | 2018 | Thereafter | ||||||||||||||||||||||
of 2014 | |||||||||||||||||||||||||||||
HETLIOZ® | $ | 7,564 | $ | 102 | $ | 411 | $ | 411 | $ | 411 | $ | 411 | $ | 5,818 | |||||||||||||||
Fanapt® | 3,755 | 433 | 1,733 | 1,589 | — | — | — | ||||||||||||||||||||||
$ | 11,319 | $ | 535 | $ | 2,144 | $ | 2,000 | $ | 411 | $ | 411 | $ | 5,818 | ||||||||||||||||
Accrued_Liabilities_Tables
Accrued Liabilities (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Summary of Accrued Liabilities | ' | ||||||||
The following is a summary of the Company’s accrued liabilities as of September 30, 2014 and December 31, 2013: | |||||||||
(in thousands) | September 30, | December 31, | |||||||
2014 | 2013 | ||||||||
Accrued research and development expenses | $ | 1,521 | $ | 2,324 | |||||
Accrued consulting and other professional fees | 2,454 | 2,015 | |||||||
Compensation and employee benefits | 1,593 | 176 | |||||||
Other accrued liabilities | 1,257 | 665 | |||||||
$ | 6,825 | $ | 5,180 | ||||||
Deferred_Revenue_Tables
Deferred Revenue (Tables) | 9 Months Ended | ||||||||
Sep. 30, 2014 | |||||||||
Summary of Changes in Total Deferred Revenue | ' | ||||||||
The following is a summary of changes in total deferred revenue for the nine months ended September 30, 2014 and 2013: | |||||||||
Nine Months Ended | |||||||||
(in thousands) | September 30, | September 30, | |||||||
2014 | 2013 | ||||||||
Balance beginning of period | $ | 90,275 | $ | 117,064 | |||||
Deferred Fanapt® product revenue | 173 | — | |||||||
Licensing revenue recognized | 22,981 | 20,037 | |||||||
Balance end of period | $ | 67,467 | $ | 97,027 | |||||
Commitments_and_Contingencies_
Commitments and Contingencies (Tables) | 9 Months Ended | ||||||||||||||||||||||||||||
Sep. 30, 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 September 30, 2014: | |||||||||||||||||||||||||||||
(in thousands) | Total | Remainder | 2015 | 2016 | 2017 | 2018 | Thereafter | ||||||||||||||||||||||
of 2014 | |||||||||||||||||||||||||||||
Operating leases | $ | 14,974 | $ | 323 | $ | 1,337 | $ | 1,500 | $ | 1,538 | $ | 1,576 | $ | 8,700 |
Employee_StockBased_Compensati1
Employee Stock-Based Compensation (Tables) | 9 Months Ended | ||||||||||||||||
Sep. 30, 2014 | |||||||||||||||||
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 nine months ended September 30, 2014 and 2013 were as follows: | |||||||||||||||||
Nine Months Ended | |||||||||||||||||
September 30, | September 30, | ||||||||||||||||
2014 | 2013 | ||||||||||||||||
Expected dividend yield | 0 | % | 0 | % | |||||||||||||
Weighted average expected volatility | 64 | % | 63 | % | |||||||||||||
Weighted average expected term (years) | 5.84 | 6.03 | |||||||||||||||
Weighted average risk-free rate | 1.76 | % | 1.28 | % | |||||||||||||
Weighted average fair value per share | $ | 7.14 | $ | 3.98 | |||||||||||||
Total Employee Stock-Based Compensation Expense | ' | ||||||||||||||||
Total employee stock-based compensation expense related to stock-based awards for the three and nine months ended September 30, 2014 and 2013 was comprised of the following: | |||||||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||||||
(in thousands) | September 30, | September 30, | September 30, | September 30, | |||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||||||
Research and development | $ | 423 | $ | 415 | $ | 1,283 | $ | 1,473 | |||||||||
Selling, general and administrative | 969 | 1,121 | 2,870 | 2,474 | |||||||||||||
$ | 1,392 | $ | 1,536 | $ | 4,153 | $ | 3,947 | ||||||||||
Summary of RSU Activity for 2006 Plan | ' | ||||||||||||||||
A summary of RSU activity for the 2006 Plan for the nine months ended September 30, 2014 follows: | |||||||||||||||||
Number of | Weighted | ||||||||||||||||
Shares | Average | ||||||||||||||||
Underlying | Grant Date | ||||||||||||||||
RSUs | Fair Value | ||||||||||||||||
Unvested at December 31, 2013 | 883,690 | $ | 7.7 | ||||||||||||||
Granted | 70,500 | 13.14 | |||||||||||||||
Forfeited | (82,282 | ) | 6.69 | ||||||||||||||
Vested | (209,562 | ) | 6.67 | ||||||||||||||
Unvested at September 30, 2014 | 662,346 | 8.74 | |||||||||||||||
2004 Plan | ' | ||||||||||||||||
Summary of Option Activity Plan | ' | ||||||||||||||||
A summary of option activity for the 2004 Plan for the nine months ended September 30, 2014 follows: | |||||||||||||||||
(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, 2013 | 670,744 | $ | 1.79 | 1.78 | $ | 7,124 | |||||||||||
Expired | — | ||||||||||||||||
Exercised | (17,934 | ) | |||||||||||||||
Outstanding at September 30, 2014 | 652,810 | 1.74 | 1.03 | 5,640 | |||||||||||||
Exercisable at September 30, 2014 | 652,810 | 1.74 | 1.03 | 5,640 | |||||||||||||
2006 Plan | ' | ||||||||||||||||
Summary of Option Activity Plan | ' | ||||||||||||||||
A summary of option activity for the 2006 Plan for the nine months ended September 30, 2014 follows: | |||||||||||||||||
(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, 2013 | 5,533,618 | $ | 10.98 | 6.93 | $ | 21,264 | |||||||||||
Granted | 259,000 | 12.22 | |||||||||||||||
Forfeited | (232,966 | ) | 8.33 | ||||||||||||||
Expired | — | ||||||||||||||||
Exercised | (367,431 | ) | 7.11 | 2,777 | |||||||||||||
Outstanding at September 30, 2014 | 5,192,221 | 11.43 | 6.31 | 11,814 | |||||||||||||
Exercisable at September 30, 2014 | 3,655,287 | 12.49 | 5.3 | 8,274 | |||||||||||||
Expected to vest at September 30, 2014 | 1,476,376 | 8.86 | 8.71 | 3,467 | |||||||||||||
Summary_of_Significant_Account1
Summary of Significant Accounting Policies - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2014 | Sep. 30, 2014 | Sep. 30, 2013 | Dec. 31, 2013 | Dec. 31, 2012 | |
Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' |
Deferred revenue, recognition period | ' | '45 days | ' | ' | ' |
Deferred revenue | $67,467,000 | $67,467,000 | $97,027,000 | $90,275,000 | $117,064,000 |
Percentage of insurance coverage gap allocated for prescription drugs | ' | 50.00% | ' | ' | ' |
Advertising expenses | 300,000 | 4,600,000 | 0 | ' | ' |
Fanapt | ' | ' | ' | ' | ' |
Summary Of Significant Accounting Policies [Line Items] | ' | ' | ' | ' | ' |
Deferred revenue | $200,000 | $200,000 | ' | ' | ' |
Change_in_Method_of_Accounting2
Change in Method of Accounting for Stock-based Compensation - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2014 | Dec. 31, 2013 | |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ' | ' | ' |
Accumulated deficit | ($357,703,000) | ($357,703,000) | ($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 | 400,000 | 1,600,000 | ' |
New Accounting Pronouncement or Change in Accounting Principle, Effect of Change on Net Income | 400,000 | 1,600,000 | ' |
New Accounting Pronouncement or Change in Accounting Principle, Effect of Change on Earnings Per Share | $0.01 | $0.05 | ' |
Accumulated deficit | ' | ' | -308,170,000 |
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 | ' | ' | $3,192,000 |
Adjustments_in_Balance_Sheet_D
Adjustments in Balance Sheet (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Stockholders' equity: | ' | ' |
Preferred stock, $0.001 par value; 20,000,000 shares authorized, and no shares issued or outstanding | $0 | ' |
Common stock, $0.001 par value; 150,000,000 shares authorized; 33,338,543 shares issued and outstanding at December 31, 2013 | 34 | 33 |
Additional paid-in capital | 358,728 | 352,240 |
Accumulated other comprehensive income | 4 | 21 |
Accumulated deficit | -357,703 | -308,170 |
Total stockholders' equity | 1,063 | 44,124 |
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 | ' | 0 |
Common stock, $0.001 par value; 150,000,000 shares authorized; 33,338,543 shares issued and outstanding at December 31, 2013 | ' | 33 |
Additional paid-in capital | ' | 352,240 |
Accumulated other comprehensive income | ' | 21 |
Accumulated deficit | ' | -308,170 |
Total stockholders' equity | ' | 44,124 |
As Previously Reported | ' | ' |
Stockholders' equity: | ' | ' |
Total stockholders' equity | ' | 44,124 |
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 | ' | 0 |
Common stock, $0.001 par value; 150,000,000 shares authorized; 33,338,543 shares issued and outstanding at December 31, 2013 | ' | 33 |
Additional paid-in capital | ' | 355,432 |
Accumulated other comprehensive income | ' | 21 |
Accumulated deficit | ' | -311,362 |
Total stockholders' equity | ' | 44,124 |
Retrospective Adjustment | Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | ' | ' |
Stockholders' equity: | ' | ' |
Additional paid-in capital | ' | -3,192 |
Accumulated deficit | ' | $3,192 |
Adjustments_in_Balance_Sheet_P
Adjustments in Balance Sheet (Parenthetical) (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
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 | 33,901,084 | 33,338,543 |
Common stock, shares outstanding | 33,901,084 | 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 | ' | 33,338,543 |
Common stock, shares outstanding | ' | 33,338,543 |
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 | ' | 33,338,543 |
Common stock, shares outstanding | ' | 33,338,543 |
Adjustments_in_Statement_of_Op
Adjustments in Statement of Operations (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Revenues: | ' | ' | ' | ' |
Licensing agreement | $7,764 | $6,753 | $22,981 | $20,037 |
Royalty revenue | 1,689 | 1,956 | 4,919 | 5,059 |
Total revenues | 14,782 | 8,709 | 34,788 | 25,096 |
Operating expenses: | ' | ' | ' | ' |
Research and development | 3,701 | 8,022 | 14,479 | 22,233 |
Selling, general and administrative | 11,290 | 5,741 | 67,321 | 15,154 |
Intangible asset amortization | 536 | 377 | 1,718 | 1,118 |
Total operating expenses | 16,230 | 14,140 | 84,419 | 38,505 |
Loss from operations | -1,448 | -5,431 | -49,631 | -13,409 |
Other income | 22 | 25 | 98 | 101 |
Net loss | -1,426 | -5,406 | -49,533 | -13,308 |
Basic and diluted net loss per share | ($0.04) | ($0.17) | ($1.46) | ($0.45) |
Weighted average shares outstanding, basic and diluted | 33,886,845 | 31,332,993 | 33,814,154 | 29,363,162 |
Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | ' | ' | ' | ' |
Revenues: | ' | ' | ' | ' |
Licensing agreement | ' | 6,753 | ' | 20,037 |
Royalty revenue | ' | 1,956 | ' | 5,059 |
Total revenues | ' | 8,709 | ' | 25,096 |
Operating expenses: | ' | ' | ' | ' |
Research and development | ' | 8,022 | ' | 22,233 |
Selling, general and administrative | ' | 5,741 | ' | 15,154 |
Intangible asset amortization | ' | 377 | ' | 1,118 |
Total operating expenses | ' | 14,140 | ' | 38,505 |
Loss from operations | ' | -5,431 | ' | -13,409 |
Other income | ' | 25 | ' | 101 |
Loss before tax benefit | ' | -5,406 | ' | -13,308 |
Tax benefit | ' | ' | ' | ' |
Net loss | ' | -5,406 | ' | -13,308 |
Basic and diluted net loss per share | ' | ($0.17) | ' | ($0.45) |
Weighted average shares outstanding, basic and diluted | ' | 31,332,993 | ' | 29,363,162 |
As Previously Reported | Change in Accounting for Amortization of Stock-Based Compensation Cost from Accelerated Attribution Method to Straight-Line Method | ' | ' | ' | ' |
Revenues: | ' | ' | ' | ' |
Licensing agreement | ' | 6,753 | ' | 20,037 |
Royalty revenue | ' | 1,956 | ' | 5,059 |
Total revenues | ' | 8,709 | ' | 25,096 |
Operating expenses: | ' | ' | ' | ' |
Research and development | ' | 8,026 | ' | 21,968 |
Selling, general and administrative | ' | 5,711 | ' | 14,743 |
Intangible asset amortization | ' | 377 | ' | 1,118 |
Total operating expenses | ' | 14,114 | ' | 37,829 |
Loss from operations | ' | -5,405 | ' | -12,733 |
Other income | ' | 25 | ' | 101 |
Loss before tax benefit | ' | -5,380 | ' | -12,632 |
Tax benefit | ' | ' | ' | ' |
Net loss | ' | -5,380 | ' | -12,632 |
Basic and diluted net loss per share | ' | ($0.17) | ' | ($0.43) |
Weighted average shares outstanding, basic and diluted | ' | 31,332,993 | ' | 29,363,162 |
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 | ' | -4 | ' | 265 |
Selling, general and administrative | ' | 30 | ' | 411 |
Total operating expenses | ' | 26 | ' | 676 |
Loss from operations | ' | -26 | ' | -676 |
Loss before tax benefit | ' | -26 | ' | -676 |
Tax benefit | ' | ' | ' | ' |
Net loss | ' | ($26) | ' | ($676) |
Basic and diluted net loss per share | ' | ' | ' | ($0.02) |
Adjustments_in_Statement_of_Co
Adjustments in Statement of Comprehensive Loss (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
New Accounting Pronouncements or Change in Accounting Principle [Line Items] | ' | ' | ' | ' |
Net loss | ($1,426) | ($5,406) | ($49,533) | ($13,308) |
Other comprehensive loss: | ' | ' | ' | ' |
Change in net unrealized loss on marketable securities | -6 | ' | -17 | -10 |
Tax provision on other comprehensive income (loss) | ' | ' | ' | ' |
Other comprehensive loss, net of tax: | -6 | ' | -17 | -10 |
Comprehensive loss | -1,432 | -5,406 | -49,550 | -13,318 |
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 | ' | -5,406 | ' | -13,308 |
Other comprehensive loss: | ' | ' | ' | ' |
Change in net unrealized loss on marketable securities | ' | ' | ' | -10 |
Tax provision on other comprehensive income (loss) | ' | ' | ' | ' |
Other comprehensive loss, net of tax: | ' | ' | ' | -10 |
Comprehensive loss | ' | -5,406 | ' | -13,318 |
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 | ' | -5,380 | ' | -12,632 |
Other comprehensive loss: | ' | ' | ' | ' |
Change in net unrealized loss on marketable securities | ' | ' | ' | -10 |
Tax provision on other comprehensive income (loss) | ' | ' | ' | ' |
Other comprehensive loss, net of tax: | ' | ' | ' | -10 |
Comprehensive loss | ' | -5,380 | ' | -12,642 |
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 | ' | -26 | ' | -676 |
Other comprehensive loss: | ' | ' | ' | ' |
Tax provision on other comprehensive income (loss) | ' | ' | ' | ' |
Comprehensive loss | ' | ($26) | ' | ($676) |
Adjustments_in_Statement_of_Ca
Adjustments in Statement of Cash Flows (Detail) (USD $) | 3 Months Ended | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Cash flows from operating activities | ' | ' | ' |
Net loss | ($5,406) | ($49,533) | ($13,308) |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' | ' |
Depreciation and amortization of property and equipment | ' | 396 | 321 |
Employee and non-employee stock-based compensation | ' | 4,247 | 3,997 |
Amortization of discounts and premiums on marketable securities | ' | -132 | -121 |
Intangible asset amortization | 377 | 1,718 | 1,118 |
Net cash used in operating activities | ' | -68,168 | -27,439 |
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 | -5,406 | ' | -13,308 |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' | ' |
Depreciation and amortization of property and equipment | ' | ' | 321 |
Employee and non-employee stock-based compensation | ' | ' | 3,997 |
Amortization of discounts and premiums on marketable securities | ' | ' | 121 |
Intangible asset amortization | 377 | ' | 1,118 |
Changes in assets and liabilities, net | ' | ' | -19,688 |
Net cash used in operating activities | ' | ' | -27,439 |
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 | -5,380 | ' | -12,632 |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' | ' |
Depreciation and amortization of property and equipment | ' | ' | 321 |
Employee and non-employee stock-based compensation | ' | ' | 3,321 |
Amortization of discounts and premiums on marketable securities | ' | ' | 121 |
Intangible asset amortization | 377 | ' | 1,118 |
Changes in assets and liabilities, net | ' | ' | -19,688 |
Net cash used in operating activities | ' | ' | -27,439 |
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 | -26 | ' | -676 |
Adjustments to reconcile net loss to net cash used in operating activities: | ' | ' | ' |
Employee and non-employee stock-based compensation | ' | ' | $676 |
Basic_and_Diluted_Net_Loss_Per
Basic and Diluted Net Loss Per Share of Common Stock (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Numerator: | ' | ' | ' | ' |
Net loss | ($1,426) | ($5,406) | ($49,533) | ($13,308) |
Denominator: | ' | ' | ' | ' |
Weighted average shares outstanding, basic and diluted | 33,886,845 | 31,332,993 | 33,814,154 | 29,363,162 |
Net loss per share, basic and diluted: | ' | ' | ' | ' |
Net loss per share | ($0.04) | ($0.17) | ($1.46) | ($0.45) |
Antidilutive securities excluded from calculations of diluted net loss per share | 3,728,109 | 3,517,934 | 3,779,497 | 4,504,339 |
Summary_of_AvailableForSale_Ma
Summary of Available-For-Sale Marketable Securities (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Fair Market Value | $40,781 | $65,586 |
Current Investment | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 40,777 | 65,565 |
Gross Unrealized Gains | 8 | 27 |
Gross Unrealized Losses | -4 | -6 |
Fair Market Value | 40,781 | 65,586 |
Current Investment | U.S. Treasury and government agencies | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 15,215 | 31,557 |
Gross Unrealized Gains | 2 | 9 |
Gross Unrealized Losses | -1 | ' |
Fair Market Value | 15,216 | 31,566 |
Current Investment | Corporate debt | ' | ' |
Schedule of Available-for-sale Securities [Line Items] | ' | ' |
Amortized Cost | 25,562 | 34,008 |
Gross Unrealized Gains | 6 | 18 |
Gross Unrealized Losses | -3 | -6 |
Fair Market Value | $25,565 | $34,020 |
Assets_Measured_at_Fair_Value_
Assets Measured at Fair Value on Recurring Basis (Detail) (USD $) | Sep. 30, 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 | $40,781 | $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 | 15,216 | 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 | $25,565 | $34,020 |
Inventory_Detail
Inventory (Detail) (USD $) | Sep. 30, 2014 |
In Thousands, unless otherwise specified | |
Inventory [Line Items] | ' |
Raw materials | $213 |
Work-in-process | 7 |
Finished goods | 796 |
Deferred cost of goods sold | 252 |
Total | $1,268 |
Summary_of_Prepaid_Expenses_an
Summary of Prepaid Expenses and Other Current Assets (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Prepaid Expenses And Other Current Assets [Line Items] | ' | ' |
Prepaid insurance | $487 | $167 |
Prepaid manufacturing cost | 608 | ' |
Other prepaid expenses and vendor advances | 2,508 | 2,408 |
Other current assets | 182 | 128 |
Total prepaid expenses and other current assets | $3,785 | $2,703 |
Summary_of_Intangible_Assets_D
Summary of Intangible Assets (Detail) (USD $) | 9 Months Ended | 12 Months Ended |
In Thousands, unless otherwise specified | Sep. 30, 2014 | Dec. 31, 2013 |
Finite-Lived Intangible Assets [Line Items] | ' | ' |
Net Carrying Amount | $11,319 | $5,037 |
Hetlioz | ' | ' |
Finite-Lived Intangible Assets [Line Items] | ' | ' |
Estimated Useful Life (Years) | '19 years | ' |
Gross Carrying Amount | 8,000 | ' |
Accumulated Amortization | 436 | ' |
Net Carrying Amount | 7,564 | ' |
Fanapt | ' | ' |
Finite-Lived Intangible Assets [Line Items] | ' | ' |
Estimated Useful Life (Years) | '7 years 6 months | '8 years |
Gross Carrying Amount | 12,000 | 12,000 |
Accumulated Amortization | 8,245 | 6,963 |
Net Carrying Amount | $3,755 | $5,037 |
Intangible_Assets_Additional_I
Intangible Assets - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | 1 Months Ended | 12 Months Ended | |||||||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Jan. 31, 2014 | Jan. 31, 2014 | Jan. 31, 2014 | 31-May-09 | Dec. 31, 2009 | Dec. 31, 2009 | Dec. 31, 2009 |
Hetlioz | Hetlioz | Hetlioz | Fanapt | Fanapt | Fanapt | Fanapt | |||||
Minimum | Maximum | Minimum | Maximum | ||||||||
Finite-Lived Intangible Assets [Line Items] | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' | ' |
Payment for original sublicense agreement | ' | ' | $8,000 | ' | $8,000 | ' | ' | $12,000 | $12,000 | ' | ' |
Estimated Patent life end date | ' | ' | ' | ' | ' | '2022-12 | '2033-01 | ' | ' | '2016-11 | '2017-05 |
Intangible asset amortization | $536 | $377 | $1,718 | $1,118 | ' | ' | ' | ' | ' | ' | ' |
Summary_of_Future_Intangible_A
Summary of Future Intangible Asset Amortization (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Finite-Lived Intangible Assets [Line Items] | ' | ' |
Net Carrying Amount | $11,319 | $5,037 |
Remainder of 2014 | 535 | ' |
2015 | 2,144 | ' |
2016 | 2,000 | ' |
2017 | 411 | ' |
2018 | 411 | ' |
Thereafter | 5,818 | ' |
Hetlioz | ' | ' |
Finite-Lived Intangible Assets [Line Items] | ' | ' |
Net Carrying Amount | 7,564 | ' |
Remainder of 2014 | 102 | ' |
2015 | 411 | ' |
2016 | 411 | ' |
2017 | 411 | ' |
2018 | 411 | ' |
Thereafter | 5,818 | ' |
Fanapt | ' | ' |
Finite-Lived Intangible Assets [Line Items] | ' | ' |
Net Carrying Amount | 3,755 | 5,037 |
Remainder of 2014 | 433 | ' |
2015 | 1,733 | ' |
2016 | $1,589 | ' |
Summary_of_Accrued_Liabilities
Summary of Accrued Liabilities (Detail) (USD $) | Sep. 30, 2014 | Dec. 31, 2013 |
In Thousands, unless otherwise specified | ||
Accrued Liabilities [Line Items] | ' | ' |
Accrued research and development expenses | $1,521 | $2,324 |
Accrued consulting and other professional fees | 2,454 | 2,015 |
Compensation and employee benefits | 1,593 | 176 |
Other accrued liabilities | 1,257 | 665 |
Accrued liabilities | $6,825 | $5,180 |
Summary_of_Changes_in_Total_De
Summary of Changes in Total Deferred Revenue (Detail) (USD $) | 9 Months Ended | |
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 |
Deferred Revenue Arrangement [Line Items] | ' | ' |
Balance beginning of period | $90,275 | $117,064 |
Deferred FanaptB. product revenue | 173 | ' |
Licensing revenue recognized | 22,981 | 20,037 |
Balance end of period | $67,467 | $97,027 |
Deferred_Revenue_Additional_In
Deferred Revenue - Additional Information (Detail) (Fanapt, USD $) | Dec. 31, 2009 |
In Millions, unless otherwise specified | |
Fanapt | ' |
Deferred Revenue Arrangement [Line Items] | ' |
Upfront payment received | $200 |
Commitments_and_Contingencies_1
Commitments and Contingencies - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | 1 Months Ended | 12 Months Ended | |||
In Millions, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 | Mar. 31, 2014 | Mar. 31, 2014 | Dec. 31, 2011 |
Washington DC Lease Amendment | Washington DC Lease | ||||||
sqft | sqft | ||||||
Commitments and Contingencies Disclosure [Line Items] | ' | ' | ' | ' | ' | ' | ' |
Renewal term of Lease agreement | ' | ' | ' | ' | ' | '5 years | '5 years |
Square feet leased | ' | ' | ' | ' | ' | 8,860 | 21,400 |
Lease term | ' | ' | ' | ' | ' | '12 years 1 month | ' |
Annual rental payment under lease amendment | ' | ' | ' | ' | $0.40 | ' | ' |
Allowance for tenant improvements | ' | ' | ' | ' | ' | 0.8 | ' |
Rent expense | $0.40 | $0.30 | $1.20 | $0.80 | ' | ' | ' |
Summary_of_Minimum_Annual_Futu
Summary of Minimum Annual Future Payments Under Operating Leases (Detail) (USD $) | Sep. 30, 2014 |
In Thousands, unless otherwise specified | |
Operating Leased Assets [Line Items] | ' |
Operating leases, Total | $14,974 |
Operating leases, Remainder of 2014 | 323 |
Operating leases, 2015 | 1,337 |
Operating leases, 2016 | 1,500 |
Operating leases, 2017 | 1,538 |
Operating leases, 2018 | 1,576 |
Operating leases, Thereafter | $8,700 |
Commitments_and_Contingencies_2
Commitments and Contingencies (Textual 1 - Consulting Agreement) - Additional Information (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Commitments and Contingencies Disclosure [Line Items] | ' | ' | ' | ' |
Research and development | $3,701 | $8,022 | $14,479 | $22,233 |
Consulting Agreement | ' | ' | ' | ' |
Commitments and Contingencies Disclosure [Line Items] | ' | ' | ' | ' |
Research and development | ' | ' | $2,000 | ' |
Commitments_and_Contingencies_3
Commitments and Contingencies (Textual 2 - HETLIOZ) - Additional Information (Detail) (USD $) | 1 Months Ended | 9 Months Ended | 1 Months Ended | 9 Months Ended | ||
Feb. 28, 2004 | Sep. 30, 2014 | Feb. 28, 2004 | Jan. 31, 2014 | Feb. 28, 2004 | Sep. 30, 2014 | |
In the event that cumulative sales of HETLIOZ reach $250.0 million | Hetlioz | Hetlioz | Hetlioz | |||
License Agreement | ||||||
Commitments and Contingencies [Line Items] | ' | ' | ' | ' | ' | ' |
Milestone payment under license agreement | ' | $8,000,000 | ' | $8,000,000 | ' | $8,000,000 |
Possible future milestone payment in the event product reaches a certain agreed upon sales threshold | ' | ' | $25,000,000 | ' | ' | ' |
Percentage of future sublicense fees payable to third-party | 'Mid-twenties | ' | ' | ' | ' | ' |
Royalty payment | ' | ' | ' | ' | 10.00% | ' |
Commitments_and_Contingencies_4
Commitments and Contingencies (Textual 3 - Fanapt) - Additional Information (Detail) (USD $) | 9 Months Ended | 1 Months Ended | 12 Months Ended |
Sep. 30, 2014 | 31-May-09 | Dec. 31, 2009 | |
Fanapt | Fanapt | ||
Fanapt | ' | ' | ' |
Milestone payment under license agreement | $8,000,000 | $12,000,000 | $12,000,000 |
Upfront payment received | ' | ' | 200,000,000 |
Potential future maximum milestone payments from Novartis | ' | ' | $265,000,000 |
Commitments_and_Contingencies_5
Commitments and Contingencies (Textual 4 - VLY 686) - Additional Information (Detail) (VLY 686, USD $) | 12 Months Ended |
In Millions, unless otherwise specified | Dec. 31, 2012 |
VLY-686 | ' |
Future percentage of royalty payments based net sales | 'Low double digits |
Possible future milestone payments | $4 |
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 $) | Sep. 30, 2014 |
Future milestone payments | ' |
Liabilities recorded, future license payments | $0 |
Liabilities recorded, contractual obligations relating to the license agreements | $0 |
Legal_Matters_Additional_Infor
Legal Matters - Additional Information (Detail) (Fanapt, USD $) | 1 Months Ended | 9 Months Ended |
In Millions, unless otherwise specified | 31-May-14 | Sep. 30, 2014 |
Gain Contingencies [Line Items] | ' | ' |
Arbitration, defending counterclaims | $75 | ' |
Patent expiration year | ' | '2027 |
Positive Outcome of Litigation | ' | ' |
Gain Contingencies [Line Items] | ' | ' |
Requested award from arbitration proceedings | $539 | ' |
Period of anticipated arbitration proceeding award | ' | 'Mid to late 2015 |
BlackScholesMerton_Option_Pric
Black-Scholes-Merton Option Pricing Model for Employee and Director Stock Options Granted (Detail) (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
Share Based Payment Award Stock Options Valuation Assumptions [Line Items] | ' | ' |
Expected dividend yield | 0.00% | 0.00% |
Weighted average expected volatility | 64.00% | 63.00% |
Weighted average expected term (years) | '5 years 10 months 2 days | '6 years 11 days |
Weighted average risk-free rate | 1.76% | 1.28% |
Weighted average fair value per share | $7.14 | $3.98 |
Total_Employee_StockBased_Comp
Total Employee Stock-Based Compensation Expense (Detail) (USD $) | 3 Months Ended | 9 Months Ended | ||
In Thousands, unless otherwise specified | Sep. 30, 2014 | Sep. 30, 2013 | Sep. 30, 2014 | Sep. 30, 2013 |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ' | ' | ' | ' |
Total employee stock-based compensation expense | $1,392 | $1,536 | $4,153 | $3,947 |
Research and development | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ' | ' | ' | ' |
Total employee stock-based compensation expense | 423 | 415 | 1,283 | 1,473 |
Selling, General and Administrative Expenses | ' | ' | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award, Compensation Cost [Line Items] | ' | ' | ' | ' |
Total employee stock-based compensation expense | $969 | $1,121 | $2,870 | $2,474 |
Employee_StockBased_Compensati2
Employee Stock-Based Compensation (Textual 1 - Employee Stock-Based Compensation) - Additional Information (Detail) | Sep. 30, 2014 | Dec. 31, 2013 |
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 |
2006 Plan | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Outstanding options granted | 5,192,221 | 5,533,618 |
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 | 5,854,567 | ' |
Shares available for future grant | 2,381,075 | ' |
Employee_StockBased_Compensati3
Employee Stock-Based Compensation (Textual 2 Stock Option) - Additional Information (Detail) (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 2013 | |
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 | '1 year 10 months 24 days | ' |
Proceeds from exercise of employee stock options | $2,677,000 | $1,062,000 |
2004 Plan | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Expected to vest at September 30, 2014 | 0 | ' |
Service option awards | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Unrecognized compensation expenses | $7,700,000 | ' |
Unrecognized compensation expenses, weighted average period | '1 year 6 months | ' |
Summary_of_Option_Activity_for
Summary of Option Activity for 2004 Plan (Detail) (2004 Plan, USD $) | 9 Months Ended | 12 Months Ended |
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2014 | Dec. 31, 2013 |
2004 Plan | ' | ' |
Number of Shares | ' | ' |
Beginning balance | 670,744 | ' |
Expired | ' | ' |
Exercised | -17,934 | ' |
Ending balance | 652,810 | 670,744 |
Exercisable | 652,810 | ' |
Weighted Average Exercise Price at Grant Date | ' | ' |
Beginning balance | $1.79 | ' |
Expired | ' | ' |
Exercised | ' | ' |
Ending balance | $1.74 | $1.79 |
Exercisable | $1.74 | ' |
Weighted Average Remaining Term (Years) | ' | ' |
Weighted Average Remaining Term | '1 year 11 days | '1 year 9 months 11 days |
Exercisable | '1 year 11 days | ' |
Aggregate Intrinsic Value | ' | ' |
Beginning balance | $7,124 | ' |
Ending balance | 5,640 | 7,124 |
Exercisable | $5,640 | ' |
Summary_of_Option_Activity_for1
Summary of Option Activity for 2006 Plan (Detail) (2006 Plan, USD $) | 9 Months Ended | 12 Months Ended |
In Thousands, except Share data, unless otherwise specified | Sep. 30, 2014 | Dec. 31, 2013 |
2006 Plan | ' | ' |
Number of Shares | ' | ' |
Beginning balance | 5,533,618 | ' |
Granted | 259,000 | ' |
Forfeited | -232,966 | ' |
Expired | ' | ' |
Exercised | -367,431 | ' |
Ending balance | 5,192,221 | 5,533,618 |
Exercisable | 3,655,287 | ' |
Expected to vest at September 30, 2014 | 1,476,376 | ' |
Weighted Average Exercise Price at Grant Date | ' | ' |
Beginning balance | $10.98 | ' |
Granted | $12.22 | ' |
Forfeited | $8.33 | ' |
Expired | ' | ' |
Exercised | $7.11 | ' |
Ending balance | $11.43 | $10.98 |
Exercisable | $12.49 | ' |
Expected to vest at September 30, 2014 | $8.86 | ' |
Weighted Average Remaining Term (Years) | ' | ' |
Weighted Average Remaining Term | '6 years 3 months 22 days | '6 years 11 months 5 days |
Exercisable | '5 years 3 months 18 days | ' |
Expected to vest at September 30, 2014 | '8 years 8 months 16 days | ' |
Aggregate Intrinsic Value | ' | ' |
Beginning balance | $21,264 | ' |
Exercised | 2,777 | ' |
Ending balance | 11,814 | 21,264 |
Exercisable | 8,274 | ' |
Expected to vest at September 30, 2014 | $3,467 | ' |
Employee_StockBased_Compensati4
Employee Stock-Based Compensation (Textual 3 RSU) - Additional Information (Detail) (USD $) | 9 Months Ended | |
Sep. 30, 2014 | Sep. 30, 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 | '1 year 10 months 24 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 |
Restricted Stock Units (RSU) | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Unrecognized compensation expenses related to unvested RSUs | $4,400,000 | ' |
2006 Plan | ' | ' |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ' | ' |
Fair value of common stock vested, shares | 209,562 | ' |
Summary_of_RSU_Activity_for_20
Summary of RSU Activity for 2006 Plan (Detail) (2006 Plan, USD $) | 9 Months Ended |
Sep. 30, 2014 | |
2006 Plan | ' |
Number of Shares Unvested | ' |
Beginning balance | 883,690 |
Granted | 70,500 |
Forfeited | -82,282 |
Vested | -209,562 |
Ending balance | 662,346 |
Weighted Average Price/Share Unvested | ' |
Beginning balance | $7.70 |
Granted | $13.14 |
Forfeited | $6.69 |
Vested | $6.67 |
Ending balance | $8.74 |