Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2015 | Jul. 15, 2015 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | XNPT | |
Entity Registrant Name | XENOPORT INC | |
Entity Central Index Key | 1,130,591 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 63,077,405 |
BALANCE SHEETS
BALANCE SHEETS - Entity [Domain] - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 31,360 | $ 11,958 |
Short-term investments | 139,057 | 90,098 |
Accounts receivable | 3,494 | 2,895 |
Inventories | 1,894 | 1,458 |
Prepaids and other current assets | 7,338 | 3,185 |
Total current assets | 183,143 | 109,594 |
Property and equipment, net | 2,208 | 2,422 |
Long-term inventories | 8,381 | 9,098 |
Restricted investments and other assets | 105 | 1,947 |
Total assets | 193,837 | 123,061 |
Current liabilities: | ||
Accounts payable | 2,598 | 2,835 |
Accrued compensation | 4,696 | 7,148 |
Accrued preclinical and clinical costs | 1,910 | 1,554 |
Other accrued liabilities | 6,184 | 5,117 |
Deferred revenue | 1,134 | 1,134 |
Total current liabilities | 16,522 | 17,788 |
Convertible senior notes, net | 111,520 | |
Deferred revenue | 10,297 | 10,864 |
Other noncurrent liability | $ 3,543 | $ 3,269 |
Commitments and contingencies | ||
Stockholders' equity: | ||
Preferred stock, $0.001 par value; 5,000 shares authorized; no shares issued or outstanding | ||
Common stock, $0.001 par value; 200,000 and 100,000 shares authorized at June 30, 2015 and December 31, 2014, respectively; 63,075 and 62,475 shares issued and outstanding at June 30, 2015 and December 31, 2014, respectively | $ 63 | $ 62 |
Additional paid-in capital | 683,533 | 677,924 |
Accumulated other comprehensive income (loss) | 65 | (30) |
Accumulated deficit | (631,706) | (586,816) |
Total stockholders' equity | 51,955 | 91,140 |
Total liabilities and stockholders' equity | $ 193,837 | $ 123,061 |
BALANCE SHEETS (Parenthetical)
BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2015 | Dec. 31, 2014 |
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 5,000,000 | 5,000,000 |
Preferred stock, shares issued | 0 | 0 |
Preferred stock, shares outstanding | 0 | 0 |
Common stock, par value | $ 0.001 | $ 0.001 |
Common stock, shares authorized | 200,000,000 | 100,000,000 |
Common stock, shares issued | 63,075,000 | 62,475,000 |
Common stock, shares outstanding | 63,075,000 | 62,475,000 |
STATEMENTS OF COMPREHENSIVE LOS
STATEMENTS OF COMPREHENSIVE LOSS - Entity [Domain] - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Revenues: | ||||
Product sales, net | $ 8,214 | $ 4,920 | $ 14,853 | $ 7,877 |
Collaboration revenue | 283 | 283 | 567 | 566 |
Royalty revenue | 124 | 131 | 268 | 266 |
Total revenues | 8,621 | 5,334 | 15,688 | 8,709 |
Operating expenses: | ||||
Cost of product sales | 506 | 599 | 960 | 1,029 |
Research and development | 6,215 | 5,203 | 12,599 | 9,860 |
Selling, general and administrative | 25,554 | 18,865 | 45,653 | 37,636 |
Total operating expenses | 32,275 | 24,667 | 59,212 | 48,525 |
Income (loss) from operations | (23,654) | (19,333) | (43,524) | (39,816) |
Interest income | 151 | 66 | 267 | 115 |
Interest expense | (978) | (120) | (1,633) | (234) |
Net income (loss) | (24,481) | (19,387) | (44,890) | (39,935) |
Other comprehensive loss: | ||||
Unrealized gains on available-for-sale securities | 3 | 18 | 95 | 14 |
Comprehensive income (loss) | $ (24,478) | $ (19,369) | $ (44,795) | $ (39,921) |
Basic and diluted net income (loss) per share | $ (0.39) | $ (0.31) | $ (0.71) | $ (0.67) |
Shares used to compute basic and diluted net loss per share | 62,920 | 61,994 | 62,821 | 59,441 |
STATEMENTS OF CASH FLOWS
STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
Operating activities | ||
Net loss | $ (44,890) | $ (39,935) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 275 | 353 |
Accretion of investment discounts and amortization of investment premiums, net | 608 | 491 |
Amortization of discount and debt issuance costs on convertible senior notes | 193 | |
Stock-based compensation expense | 5,867 | 5,109 |
Changes in assets and liabilities: | ||
Accounts receivable | (599) | (709) |
Prepaids and other current and noncurrent assets | (2,311) | (603) |
Inventories | 281 | 339 |
Accounts payable | (237) | 2,105 |
Accrued compensation | (2,452) | 924 |
Accrued preclinical and clinical costs | 356 | 17 |
Other accrued liabilities, current and noncurrent | 1,341 | 2,480 |
Deferred revenue, current and noncurrent | (567) | 19,434 |
Net cash used in operating activities | (42,135) | (9,995) |
Investing activities | ||
Purchases of investments | (131,844) | (103,541) |
Proceeds from maturities of investments | 82,374 | 48,843 |
Purchases of property and equipment | (62) | (177) |
Net cash used in investing activities | (49,532) | (54,875) |
Financing activities | ||
Proceeds from issuance of convertible senior notes, net of discount and debt issuance costs | 111,327 | |
Net cash proceeds provided by (used in) issuance of common stock and exercise of stock options | (258) | 76,938 |
Net cash provided by financing activities | 111,069 | 76,938 |
Net increase in cash and cash equivalents | 19,402 | 12,068 |
Cash and cash equivalents at beginning of period | 11,958 | 20,584 |
Cash and cash equivalents at end of period | $ 31,360 | $ 32,652 |
Organization and Summary of Sig
Organization and Summary of Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2015 | |
Organization and Summary of Significant Accounting Policies | 1. Organization and Summary of Significant Accounting Policies Nature of Operations XenoPort, Inc., or the Company, is a biopharmaceutical company focused on developing and commercializing a portfolio of internally discovered product candidates for the potential treatment of neurological and other disorders. The Company is currently commercializing HORIZANT ® Basis of Preparation The accompanying financial statements as of June 30, 2015, and for the three and six months ended June 30, 2015 and 2014, are unaudited. These unaudited financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s financial position as of June 30, 2015 and comprehensive losses for the three and six months ended June 30, 2015 and 2014, and cash flows for the six months ended June 30, 2015 and 2014. The Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or the Codification, is the single source of authoritative U.S. generally accepted accounting principles, or GAAP. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from these estimates. The results of operations for the three and six months ended June 30, 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015, or for any other interim period or any other future year. For more complete financial information, these financial statements, and the notes hereto, should be read in conjunction with the audited financial statements for the year ended December 31, 2014 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2015. Recent Accounting Pronouncements In May 2014, the FASB issued Accounting Standards Update, or ASU, No. 2014-09, Revenue from Contracts with Customers: Topic 606 In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements — Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern substantial doubt; In April 2015, the FASB issued ASU No. 2015-03, Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs. In April 2015, the FASB issued ASU No. 2015-05, Intangibles – Goodwill and Other – Internal Use Software (Subtopic 350-40): Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement. |
License and Collaboration Arran
License and Collaboration Arrangements | 6 Months Ended |
Jun. 30, 2015 | |
License and Collaboration Arrangements | 2. License and Collaboration Arrangements Indivior PLC In May 2014, the Company entered into an exclusive license agreement with Indivior, which became effective on June 19, 2014. Under the terms of this agreement, the Company granted to Indivior exclusive, world-wide rights to develop and commercialize pharmaceutical products containing AP Products for all indications, subject to its right of first negotiation with Indivior to collaborate to develop and commercialize AP Products for non-addiction indications. In exchange for these rights, the Company received an upfront, non-refundable cash payment of $20,000,000 in June 2014 and also received an additional $5,000,000 payment in July 2014 after delivery of specified materials to Indivior. The Company is also eligible to receive aggregate cash payments of up to $120,000,000 upon the achievement by Indivior of certain contingent event-based payments, of which $70,000,000 are regulatory and development-based and $50,000,000 are commercialization-based. In addition, the Company is entitled to receive tiered double-digit royalty payments of up to the mid-teens on a percentage basis on potential future net sales of the products in the United States, and high single-digit royalty payments on potential future net sales of the products outside the United States. The Company also agreed to transfer its existing AP Investigational New Drug applications, or INDs, and know-how to Indivior, and to provide supply transition assistance to facilitate the establishment of Indivior’s AP Product manufacturing capabilities pursuant to a mutually agreed supply transition plan. The Company assessed its transfer and assistance obligations under the Indivior agreement using the multiple-element arrangements revenue recognition guidance since those obligations involved more than one deliverable to Indivior. This analysis involved identification of the deliverables, determining if they qualify as separate units of accounting, arriving at fair value estimates for each separate unit of accounting, and allocating total consideration to each unit of accounting. The Company identified the following non-contingent deliverables under the license agreement: (1) grant of exclusive rights, or the license; (2) transfer of know-how necessary for the manufacture and development of AP Products; (3) transfer of INDs; (4) transfer of specified materials; and (5) supply of transition assistance to facilitate the establishment of Indivior’s AP Product manufacturing capabilities pursuant to a mutually agreed upon supply transition plan. The license, know-how, INDs and supply of transition assistance deliverables were combined into one unit of accounting since each of these deliverables was dependent on, and not separate from each other, and accordingly did not have stand-alone value. The transfer of specified materials represented the other unit of accounting. The total of the upfront cash payment of $20,000,000 and the additional cash payment of $5,000,000 were allocated into two units of accounting using the relative estimated selling price method. The Company developed its best estimate of selling prices for each deliverable in order to allocate the non-contingent arrangement consideration to the two units of accounting. For the license, know-how, INDs and supply of transition assistance, the Company used the discounted cash flow method to estimate the price at which it could sell them on a stand-alone basis. Embedded in the estimate were significant assumptions including: (1) probabilities of success during the development process; (2) potential customer market for the drug; (3) selling price for the drug; (4) costs to develop, maintain and manufacture the developed drug; and (5) discount rate. For the transfer of specified materials, the Company estimated the selling price based on the cost to purchase such materials from third party suppliers. Both the initial upfront cash payment of $20,000,000 and the additional cash payment of $5,000,000 were recognized as collaboration revenue upon the transfer of the deliverables to Indivior, which occurred in the third quarter of 2014. Astellas Pharma Inc. Under a December 2005 license agreement with Astellas Pharma Inc., as amended in July 2012, Astellas is commercializing gabapentin enacarbil in Japan under the trade name of REGNITE ® |
Net Loss per Share
Net Loss per Share | 6 Months Ended |
Jun. 30, 2015 | |
Net Loss per Share | 3. Net Loss per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period without consideration for potential common shares. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares outstanding for the period plus any dilutive potential common shares for the period determined using the treasury-stock method for restricted stock units and options to purchase stock and using the if-converted method for the convertible senior notes. For purposes of this calculation, restricted stock units, options to purchase stock and convertible senior notes are considered to be potential common shares and are only included in the calculation of diluted net loss per share when their effect is dilutive. Three Months Ended Six Months Ended June 30, June 30, 2015 2014 2015 2014 (In thousands, except (In thousands, except per share amounts) per share amounts) Numerator: Net loss $ (24,481 ) $ (19,387 ) $ (44,890 ) $ (39,935 ) Denominator: Weighted-average common shares outstanding 62,920 61,994 62,821 59,441 Basic and diluted net loss per share $ (0.39 ) $ (0.31 ) $ (0.71 ) $ (0.67 ) Outstanding securities at period end not included in the computation of diluted net loss per share as they had an anti-dilutive effect: Restricted stock units and options to purchase common stock 9,155 8,148 9,155 8,148 Convertible senior notes 10,729 — 10,729 — 19,884 8,148 19,884 8,148 On January 29, 2014, the Company completed an underwritten public offering of 12,000,000 shares of its common stock at a price to the public of $6.00 per share. On February 21, 2014, the underwriters exercised in full their option to purchase 1,800,000 additional shares. On February 3, 2015, the Company completed a private placement of $115,000,000 aggregate principal amount of 2.50% Convertible Senior Notes due 2022, or the 2022 Notes. The 2022 Notes are convertible at an initial conversion rate of 93.2945 shares of the Company’s common stock per $1,000 principal amount of the 2022 Notes, which is equal to an initial conversion price of approximately $10.72 per share of common stock. As of June 30, 2015, 10,728,867 shares of the Company’s common stock were issuable upon conversion of the 2022 Notes (see Note 7 for more information). |
Cash and Cash Equivalents, Shor
Cash and Cash Equivalents, Short-Term Investments and Restricted Investments | 6 Months Ended |
Jun. 30, 2015 | |
Cash and Cash Equivalents, Short-Term Investments and Restricted Investments | 4. Cash and Cash Equivalents, Short-Term Investments and Restricted Investments The following are summaries of cash and cash equivalents, short-term investments and restricted investments (in thousands): Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value As of June 30, 2015: Cash $ 1,919 $ 1,919 Money market funds 25,534 25,534 Corporate debt securities 142,899 89 (24 ) 142,964 Certificates of deposit 1,725 1,725 $ 172,077 $ 89 $ (24 ) $ 172,142 Reported as: Cash and cash equivalents $ 31,360 Short-term investments 139,057 Restricted investments (1) 1,725 $ 172,142 As of December 31, 2014: Cash $ 3,383 $ — $ — $ 3,383 Money market funds 8,576 — — 8,576 U.S. government-sponsored agencies 2,000 — (2 ) 1,998 Corporate debt securities 88,127 12 (40 ) 88,099 Certificates of deposit 1,725 — — 1,725 $ 103,811 $ 12 $ (42 ) $ 103,781 Reported as: Cash and cash equivalents $ 11,958 Short-term investments 90,098 Restricted investments (1) 1,725 $ 103,781 (1) Included in “Prepaids and other current assets” and “Restricted investments and other assets” as of June 30, 2015 and December 31, 2014, respectively. The Company considers all highly liquid investments with original maturities of 90 days or less at the time of purchase to be cash equivalents, which primarily consist of money market funds. Management determines the appropriate classification of securities at the time of purchase. All investments have been designated as available-for-sale. The Company classifies its available-for-sale investments as either current or noncurrent based on their maturities and the Company’s intent with regard to those investments. The Company currently views its available-for-sale investments that mature within one year as available for its current operations and classified as short-term investments, while available-for-sale investments that mature beyond one year are classified as long-term investments. All available-for-sale securities are carried at estimated fair value with unrealized gains and losses reported as a component of other comprehensive loss in the statements of comprehensive loss. No gross realized gains or losses were recognized and accordingly, there were no amounts reclassified out of accumulated other comprehensive income (loss) to earnings in the three and six months ended June 30, 2015 or in the same periods in 2014. The Company’s available-for-sale investments, which include cash equivalents and short-term investments, are measured at fair value on a recurring basis and are classified at the following fair value hierarchy (in thousands): Fair Value Measurements at Reporting Date Using Description Total As of Quoted Prices in Significant Other (Level 2) Significant Money market funds $ 25,534 $ 25,534 $ — $ — Corporate debt securities 142,964 — 142,964 — Certificates of deposit 1,725 — 1,725 — Total $ 170,223 $ 25,534 $ 144,689 $ — Fair Value Measurements at Reporting Date Using Description Total As of Quoted Prices in Identical Assets Significant Other Significant Money market funds $ 8,576 $ 8,576 $ — $ — U.S. government-sponsored agencies 1,998 — 1,998 — Corporate debt securities 88,099 — 88,099 — Certificates of deposit 1,725 — 1,725 — Total $ 100,398 $ 8,576 $ 91,822 $ — |
Inventories
Inventories | 6 Months Ended |
Jun. 30, 2015 | |
Inventories | 5. Inventories Inventories are stated at the lower of cost or market. Cost is determined on a first-in, first-out, or FIFO, basis. Inventories include active pharmaceutical ingredient, or API, contract manufacturing costs and overhead allocations. The Company regularly evaluates the Company’s inventories for excess quantities and obsolescence (expiration), taking into account such factors as historical and anticipated future sales compared to quantities on hand and the remaining shelf life of HORIZANT. Write-downs of inventories are considered to be permanent reductions in the cost basis of inventories. Inventories that are not expected to be consumed within 12 months following the balance sheet date are classified as long-term inventories. Inventories as of June 30, 2015 and December 31, 2014 were as follows (in thousands): June 30, December 31, 2015 2014 Raw materials $ 8,445 $ 9,273 Work in progress 121 517 Finished goods 1,709 766 Total inventory 10,275 10,556 Less: Long-term inventories 8,381 9,098 Total inventory classified as current $ 1,894 $ 1,458 Long-term inventories primarily consisted of gabapentin enacarbil API used for production of HORIZANT. The Company evaluates demand for HORIZANT and expected consumption of the API based on long-term projected sales of HORIZANT. |
Other Accrued Liabilities
Other Accrued Liabilities | 6 Months Ended |
Jun. 30, 2015 | |
Other Accrued Liabilities | 6. Other Accrued Liabilities Other accrued liabilities at June 30, 2015 and December 31, 2014 were as follows (in thousands): June 30, December 31, 2015 2014 Accrued product costs $ 165 $ 2,009 Accrued selling and marketing expenses 1,691 1,210 Accrued general and administrative expenses 922 466 Accrued rebates, allowances and returns 1,468 986 Interest payable - convertible senior notes 1,166 — Other liabilities 772 446 Total other accrued liabilities $ 6,184 $ 5,117 |
Convertible Senior Notes
Convertible Senior Notes | 6 Months Ended |
Jun. 30, 2015 | |
Convertible Senior Notes | 7. Convertible Senior Notes On February 3, 2015, the Company completed a private placement of $115,000,000 aggregate principal amount of the 2022 Notes. The net proceeds from the offering of the 2022 Notes were $111,327,000, after deducting the initial purchaser’s discount and debt issuance costs payable by the Company. Beginning on August 1, 2015, interest on the 2022 Notes will be payable semi-annually in cash in arrears on February 1 and August 1 of each year, at a rate of 2.50% per year. The 2022 Notes mature on February 1, 2022, unless earlier converted or repurchased. The 2022 Notes are not redeemable prior to the maturity date. Holders may convert all or any portion of their 2022 Notes at their option at any time prior to the close of business on the business day immediately preceding the maturity date. The 2022 Notes are convertible at an initial conversion rate of 93.2945 shares of the Company’s common stock per $1,000 principal amount of the 2022 Notes, subject to adjustment, which is equal to an initial conversion price of approximately $10.72 per share of common stock. Upon conversion, the 2022 Notes may be settled in shares of the Company’s common stock, together with a cash payment in lieu of delivering any fractional share. The conversion rate will be subject to adjustment in some events but will not be adjusted for any accrued and unpaid interest. In addition, following certain corporate events that may occur prior to the maturity date, the Company will increase the conversion rate for a holder who elects to convert its 2022 Notes in connection with such a corporate event in certain circumstances. If the Company undergoes a fundamental change, which would include specified change of control transactions, or liquidation or dissolution or the Company’s common stock ceasing to be listed or quoted on specified national securities exchanges, and the fundamental change occurs prior to the maturity date of the 2022 Notes, holders of the 2022 Notes may require the Company to repurchase all or part of their 2022 Notes at a repurchase price equal to 100% of the principal amount of the 2022 Notes to be repurchased, plus accrued and unpaid interest to, but excluding, the fundamental change repurchase date. As of June 30, 2015, the outstanding principal balance on the 2022 Notes was $115,000,000 and 10,728,867 shares of the Company’s common stock were issuable upon conversion of the 2022 Notes. The 2022 Notes are accounted for in accordance with ASC Subtopic 470-20, Debt with Conversion and Other Options The Company incurred $568,000 in debt issuance costs in connection with the issuance of the 2022 Notes, which are being amortized through the maturity date through the application of the interest method and reported as interest expense. In accordance with ASU No. 2015-03, the Company has presented debt issuance costs as a direct deduction from the carrying value of the 2022 Notes. As of June 30, 2015, the 2022 Notes were reported at their current carrying value which approximated fair value based on Level 3 unobservable inputs involving discounted cash flows and the estimated market rate of borrowing that could be obtained by companies with credit risk similar to the Company’s credit risk. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2015 | |
Stock-Based Compensation | 8. Stock-Based Compensation The Company’s non-cash stock-based compensation expense was as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2015 2014 2015 2014 (In thousands) (In thousands) Research and development $ 747 $ 622 $ 1,129 $ 1,324 Selling, general and administrative 2,449 1,803 4,738 3,785 $ 3,196 $ 2,425 $ 5,867 $ 5,109 |
Stockholders' Equity
Stockholders' Equity | 6 Months Ended |
Jun. 30, 2015 | |
Stockholders' Equity | 9. Stockholders’ Equity Common Stock On May 19, 2015, the Company’s stockholders approved an amendment to the Company’s Amended and Restated Certificate of Incorporation to increase the number of authorized shares of the Company’s common stock from 100,000,000 shares to 200,000,000 shares. The increase in the number of authorized shares of the Company’s common stock was effected pursuant to a Certificate of Amendment of Amended and Restated Certificate of Incorporation filed with the Secretary of State of the State of Delaware on May 19, 2015 and was effective as of such date. Employee Stock Purchase Plan On May 19, 2015, the Company’s stockholders also approved the XenoPort, Inc. 2015 Employee Stock Purchase Plan, or the 2015 ESPP, which became effective on May 19, 2015. The Company’s prior plan, the 2005 Employee Stock Purchase Plan, was terminated as a result of this approval. The 2015 ESPP will be implemented by offerings of rights to purchase the Company’s common stock to all eligible employees. The plan administrator will determine the duration of each offering period, provided that in no event may an offering period exceed 27 months. Each offering period will have one or more purchase dates, as determined by the plan administrator prior to the commencement of the offering period. The purchase price per share at which shares of the Company’s common stock are purchased on each purchase date during an offering period will not be less than the lower of (i) 85% of the fair market value of a share of the Company’s common stock on the first day of the offering period or (ii) 85% of the fair market value of a share of the Company’s common stock on the purchase date. The maximum number of shares of the Company’s common stock that may be issued under the 2015 ESPP is 4,000,000 shares, subject to adjustment for certain changes in the Company’s capitalization. At June 30, 2015, there were 4,000,000 shares available for future grant under the 2015 ESPP. |
Organization and Summary of S15
Organization and Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2015 | |
Basis of Preparation | Basis of Preparation The accompanying financial statements as of June 30, 2015, and for the three and six months ended June 30, 2015 and 2014, are unaudited. These unaudited financial statements have been prepared on the same basis as the annual financial statements and, in the opinion of management, reflect all adjustments, which include only normal recurring adjustments, necessary to present fairly the Company’s financial position as of June 30, 2015 and comprehensive losses for the three and six months ended June 30, 2015 and 2014, and cash flows for the six months ended June 30, 2015 and 2014. The Financial Accounting Standards Board, or FASB, Accounting Standards Codification, or the Codification, is the single source of authoritative U.S. generally accepted accounting principles, or GAAP. The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Actual results could differ from these estimates. The results of operations for the three and six months ended June 30, 2015 are not necessarily indicative of the results to be expected for the year ending December 31, 2015, or for any other interim period or any other future year. For more complete financial information, these financial statements, and the notes hereto, should be read in conjunction with the audited financial statements for the year ended December 31, 2014 included in the Company’s Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2015. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the FASB issued Accounting Standards Update, or ASU, No. 2014-09, Revenue from Contracts with Customers: Topic 606 In August 2014, the FASB issued ASU No. 2014-15, Presentation of Financial Statements — Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern substantial doubt; In April 2015, the FASB issued ASU No. 2015-03, Interest - Imputation of Interest (Subtopic 835-30): Simplifying the Presentation of Debt Issuance Costs. In April 2015, the FASB issued ASU No. 2015-05, Intangibles – Goodwill and Other – Internal Use Software (Subtopic 350-40): Customer’s Accounting for Fees Paid in a Cloud Computing Arrangement. |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Net Loss Per Share | Three Months Ended Six Months Ended June 30, June 30, 2015 2014 2015 2014 (In thousands, except (In thousands, except per share amounts) per share amounts) Numerator: Net loss $ (24,481 ) $ (19,387 ) $ (44,890 ) $ (39,935 ) Denominator: Weighted-average common shares outstanding 62,920 61,994 62,821 59,441 Basic and diluted net loss per share $ (0.39 ) $ (0.31 ) $ (0.71 ) $ (0.67 ) Outstanding securities at period end not included in the computation of diluted net loss per share as they had an anti-dilutive effect: Restricted stock units and options to purchase common stock 9,155 8,148 9,155 8,148 Convertible senior notes 10,729 — 10,729 — 19,884 8,148 19,884 8,148 |
Cash and Cash Equivalents, Sh17
Cash and Cash Equivalents, Short-Term Investments and Restricted Investments (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Cash and Cash Equivalents, Short-Term Investments and Restricted Investments | The following are summaries of cash and cash equivalents, short-term investments and restricted investments (in thousands): Cost Gross Unrealized Gains Gross Unrealized Losses Estimated Fair Value As of June 30, 2015: Cash $ 1,919 $ 1,919 Money market funds 25,534 25,534 Corporate debt securities 142,899 89 (24 ) 142,964 Certificates of deposit 1,725 1,725 $ 172,077 $ 89 $ (24 ) $ 172,142 Reported as: Cash and cash equivalents $ 31,360 Short-term investments 139,057 Restricted investments (1) 1,725 $ 172,142 As of December 31, 2014: Cash $ 3,383 $ — $ — $ 3,383 Money market funds 8,576 — — 8,576 U.S. government-sponsored agencies 2,000 — (2 ) 1,998 Corporate debt securities 88,127 12 (40 ) 88,099 Certificates of deposit 1,725 — — 1,725 $ 103,811 $ 12 $ (42 ) $ 103,781 Reported as: Cash and cash equivalents $ 11,958 Short-term investments 90,098 Restricted investments (1) 1,725 $ 103,781 (1) Included in “Prepaids and other current assets” and “Restricted investments and other assets” as of June 30, 2015 and December 31, 2014, respectively. |
Available-For-Sale Investments Measured at Fair Value | Fair Value Measurements at Reporting Date Using Description Total As of Quoted Prices in Significant Other (Level 2) Significant Money market funds $ 25,534 $ 25,534 $ — $ — Corporate debt securities 142,964 — 142,964 — Certificates of deposit 1,725 — 1,725 — Total $ 170,223 $ 25,534 $ 144,689 $ — Fair Value Measurements at Reporting Date Using Description Total As of Quoted Prices in Identical Assets Significant Other Significant Money market funds $ 8,576 $ 8,576 $ — $ — U.S. government-sponsored agencies 1,998 — 1,998 — Corporate debt securities 88,099 — 88,099 — Certificates of deposit 1,725 — 1,725 — Total $ 100,398 $ 8,576 $ 91,822 $ — |
Inventories (Tables)
Inventories (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Inventory | Inventories as of June 30, 2015 and December 31, 2014 were as follows (in thousands): June 30, December 31, 2015 2014 Raw materials $ 8,445 $ 9,273 Work in progress 121 517 Finished goods 1,709 766 Total inventory 10,275 10,556 Less: Long-term inventories 8,381 9,098 Total inventory classified as current $ 1,894 $ 1,458 |
Other Accrued Liabilities (Tabl
Other Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Other Accrued Liabilities | Other accrued liabilities at June 30, 2015 and December 31, 2014 were as follows (in thousands): June 30, December 31, 2015 2014 Accrued product costs $ 165 $ 2,009 Accrued selling and marketing expenses 1,691 1,210 Accrued general and administrative expenses 922 466 Accrued rebates, allowances and returns 1,468 986 Interest payable - convertible senior notes 1,166 — Other liabilities 772 446 Total other accrued liabilities $ 6,184 $ 5,117 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Non-Cash Stock-Based Compensation | The Company’s non-cash stock-based compensation expense was as follows (in thousands): Three Months Ended Six Months Ended June 30, June 30, 2015 2014 2015 2014 (In thousands) (In thousands) Research and development $ 747 $ 622 $ 1,129 $ 1,324 Selling, general and administrative 2,449 1,803 4,738 3,785 $ 3,196 $ 2,425 $ 5,867 $ 5,109 |
Organization and Summary of S21
Organization and Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended |
Mar. 31, 2015 | Jun. 30, 2015 | |
Convertible Senior Notes Due 2022 | ||
Organization and Summary of Significant Accounting Policies Disclosure [Line Items] | ||
Debt issuance cost | $ 568,000 | $ 568,000 |
License and Collaboration Arr22
License and Collaboration Arrangements - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||||
Jul. 31, 2014 | Jun. 30, 2014 | Jun. 30, 2015 | Sep. 30, 2014 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2014 | May. 31, 2014 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Collaboration revenue | $ 283,000 | $ 283,000 | $ 567,000 | $ 566,000 | |||||
Royalty revenue | 124,000 | 131,000 | 268,000 | 266,000 | |||||
Revenue recognized | 8,621,000 | 5,334,000 | 15,688,000 | 8,709,000 | |||||
Deferred revenue, current | 1,134,000 | 1,134,000 | $ 1,134,000 | ||||||
Deferred revenue, non-current | 10,297,000 | 10,297,000 | $ 10,864,000 | ||||||
Licensing Agreements | Indivior PLC | Upfront, non-refundable cash payment | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Deferred revenue, initial up-front license payment and payment for specified materials received | $ 20,000,000 | ||||||||
Collaboration revenue | $ 20,000,000 | ||||||||
Licensing Agreements | Indivior PLC | Additional payment for specified materials | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Deferred revenue, initial up-front license payment and payment for specified materials received | $ 5,000,000 | ||||||||
Collaboration revenue | $ 5,000,000 | ||||||||
Licensing Agreements | Indivior PLC | Achievement of certain predefined milestones | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Payments, maximum amount | $ 120,000,000 | ||||||||
Licensing Agreements | Indivior PLC | Regulatory and development-based milestones | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Payments, maximum amount | 70,000,000 | ||||||||
Licensing Agreements | Indivior PLC | Commercialization-based milestones | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Payments, maximum amount | $ 50,000,000 | ||||||||
Licensing Agreements | Astellas Pharma Inc. | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Royalty revenue | 124,000 | 131,000 | 268,000 | 266,000 | |||||
Revenue recognized | 54,908,000 | ||||||||
Deferred revenue | 11,431,000 | 11,431,000 | |||||||
Deferred revenue, current | 1,134,000 | 1,134,000 | |||||||
Deferred revenue, non-current | 10,297,000 | 10,297,000 | |||||||
Licensing Agreements | Astellas Pharma Inc. | Upfront, non-refundable cash payment | |||||||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||||||
Collaboration revenue | $ 283,000 | $ 283,000 | $ 567,000 | $ 566,000 |
Net Loss Per Share (Detail)
Net Loss Per Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Numerator: | ||||
Net loss | $ (24,481) | $ (19,387) | $ (44,890) | $ (39,935) |
Denominator: | ||||
Weighted-average common shares outstanding | 62,920 | 61,994 | 62,821 | 59,441 |
Basic and diluted net loss per share | $ (0.39) | $ (0.31) | $ (0.71) | $ (0.67) |
Outstanding securities at period end not included in the computation of diluted net loss per share as they had an anti-dilutive effect: | ||||
Outstanding securities not included in the computation of diluted net loss per share | 19,884 | 8,148 | 19,884 | 8,148 |
Restricted stock units and options to purchase common stock | ||||
Outstanding securities at period end not included in the computation of diluted net loss per share as they had an anti-dilutive effect: | ||||
Outstanding securities not included in the computation of diluted net loss per share | 9,155 | 8,148 | 9,155 | 8,148 |
Convertible Senior Notes | ||||
Outstanding securities at period end not included in the computation of diluted net loss per share as they had an anti-dilutive effect: | ||||
Outstanding securities not included in the computation of diluted net loss per share | 10,729 | 10,729 |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) | Feb. 03, 2015USD ($)$ / shares | Jan. 29, 2014$ / sharesshares | Jun. 30, 2015USD ($)shares | Feb. 21, 2014shares |
Computation of Earnings Per Share [Line Items] | ||||
Underwriters exercised the full option to purchase additional shares | 1,800,000 | |||
Convertible Senior Notes Due 2022 | ||||
Computation of Earnings Per Share [Line Items] | ||||
Convertible senior notes, principal offer amount | $ | $ 115,000,000 | $ 115,000,000 | ||
Convertible senior notes, stated interest rate | 2.50% | |||
Convertible senior notes, due date | 2,022 | |||
Convertible senior notes, conversion share per 1000 principal amount | 93.2945 | |||
Convertible senior notes, initial conversion price | $ / shares | $ 10.72 | |||
Common stock issuable upon conversion cf convertible senior notes | 10,728,867 | |||
Underwritten Public Offering | ||||
Computation of Earnings Per Share [Line Items] | ||||
Common stock issued in underwritten public offering | 12,000,000 | |||
Common stock price | $ / shares | $ 6 |
Cash and Cash Equivalents, Sh25
Cash and Cash Equivalents, Short-Term Investments and Restricted Investments (Detail) - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 | |
Cash Cash Equivalents Short Term Investments and Restricted Investments [Line Items] | |||
Cost | $ 172,077 | $ 103,811 | |
Gross Unrealized Gains | 89 | 12 | |
Gross Unrealized Losses | (24) | (42) | |
Estimated Fair Value | 172,142 | 103,781 | |
Cash | |||
Cash Cash Equivalents Short Term Investments and Restricted Investments [Line Items] | |||
Available for Sale Securities Cost | 1,919 | 3,383 | |
Available-for-sale investments | 1,919 | 3,383 | |
Money market funds | |||
Cash Cash Equivalents Short Term Investments and Restricted Investments [Line Items] | |||
Available for Sale Securities Cost | 25,534 | 8,576 | |
Available-for-sale investments | 25,534 | 8,576 | |
Corporate debt securities | |||
Cash Cash Equivalents Short Term Investments and Restricted Investments [Line Items] | |||
Available for Sale Securities Cost | 142,899 | 88,127 | |
Gross Unrealized Gains | 89 | 12 | |
Gross Unrealized Losses | (24) | (40) | |
Available-for-sale investments | 142,964 | 88,099 | |
Certificates of deposit | |||
Cash Cash Equivalents Short Term Investments and Restricted Investments [Line Items] | |||
Restricted Cost | 1,725 | 1,725 | |
Restricted Fair Value | 1,725 | 1,725 | |
Cash and cash equivalents | |||
Cash Cash Equivalents Short Term Investments and Restricted Investments [Line Items] | |||
Available-for-sale investments | 31,360 | 11,958 | |
Short-term investments | |||
Cash Cash Equivalents Short Term Investments and Restricted Investments [Line Items] | |||
Available-for-sale investments | 139,057 | 90,098 | |
Restricted Investments | |||
Cash Cash Equivalents Short Term Investments and Restricted Investments [Line Items] | |||
Restricted Fair Value | [1] | $ 1,725 | 1,725 |
U.S. government-sponsored agencies | |||
Cash Cash Equivalents Short Term Investments and Restricted Investments [Line Items] | |||
Available for Sale Securities Cost | 2,000 | ||
Gross Unrealized Losses | (2) | ||
Available-for-sale investments | $ 1,998 | ||
[1] | Included in "Prepaids and other current assets" and "Restricted investments and other assets" as of June 30, 2015 and December 31, 2014, respectively. |
Cash and Cash Equivalents, Sh26
Cash and Cash Equivalents, Short-Term Investments and Restricted Investments - Additional Information (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Cash Cash Equivalents Short Term Investments and Restricted Investments [Line Items] | ||||
Gross realized gains or losses recognized | $ 0 | $ 0 | $ 0 | $ 0 |
Amounts reclassified out of accumulated other comprehensive loss to earnings | $ 0 | $ 0 | $ 0 | $ 0 |
Available-For-Sale Investments
Available-For-Sale Investments Measured at Fair Value (Detail) - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Estimated Fair Value | $ 172,142 | $ 103,781 |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 25,534 | 8,576 |
U.S. government-sponsored agencies | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 1,998 | |
Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 142,964 | 88,099 |
Certificates of deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Restricted Fair Value | 1,725 | 1,725 |
Fair Value Measurements, Recurring basis | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Estimated Fair Value | 170,223 | 100,398 |
Fair Value Measurements, Recurring basis | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 25,534 | 8,576 |
Fair Value Measurements, Recurring basis | U.S. government-sponsored agencies | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 1,998 | |
Fair Value Measurements, Recurring basis | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 142,964 | 88,099 |
Fair Value Measurements, Recurring basis | Certificates of deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Restricted Fair Value | 1,725 | 1,725 |
Fair Value Measurements, Recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Estimated Fair Value | 25,534 | 8,576 |
Fair Value Measurements, Recurring basis | Quoted Prices in Active Markets for Identical Assets (Level 1) | Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 25,534 | 8,576 |
Fair Value Measurements, Recurring basis | Significant Other Observable Inputs (Level 2) | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Estimated Fair Value | 144,689 | 91,822 |
Fair Value Measurements, Recurring basis | Significant Other Observable Inputs (Level 2) | U.S. government-sponsored agencies | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 1,998 | |
Fair Value Measurements, Recurring basis | Significant Other Observable Inputs (Level 2) | Corporate debt securities | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale investments | 142,964 | 88,099 |
Fair Value Measurements, Recurring basis | Significant Other Observable Inputs (Level 2) | Certificates of deposit | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Restricted Fair Value | $ 1,725 | $ 1,725 |
Inventory (Detail)
Inventory (Detail) - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 8,445 | $ 9,273 |
Work in progress | 121 | 517 |
Finished goods | 1,709 | 766 |
Total inventory | 10,275 | 10,556 |
Less: Long-term inventories | 8,381 | 9,098 |
Total inventory classified as current | $ 1,894 | $ 1,458 |
Other Accrued Liabilities (Deta
Other Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Payables And Accruals [Abstract] | ||
Accrued product costs | $ 165 | $ 2,009 |
Accrued selling and marketing expenses | 1,691 | 1,210 |
Accrued general and administrative expenses | 922 | 466 |
Accrued rebates, allowances and returns | 1,468 | 986 |
Interest payable - convertible senior notes | 1,166 | |
Other liabilities | 772 | 446 |
Total other accrued liabilities | $ 6,184 | $ 5,117 |
Convertible Senior Notes - Addi
Convertible Senior Notes - Additional Information (Detail) - USD ($) | Feb. 03, 2015 | Mar. 31, 2015 | Jun. 30, 2015 |
Debt Instrument [Line Items] | |||
Proceeds from issuance of convertible senior notes, net of discount and debt issuance costs | $ 111,327,000 | ||
Convertible Senior Notes Due 2022 | |||
Debt Instrument [Line Items] | |||
Convertible senior notes, principal offer amount | $ 115,000,000 | 115,000,000 | |
Convertible senior notes, due date | 2,022 | ||
Proceeds from issuance of convertible senior notes, net of discount and debt issuance costs | $ 111,327,000 | ||
Convertible senior notes, repayment terms | Beginning on August 1, 2015, interest on the 2022 Notes will be payable semi-annually in cash in arrears on February 1 and August 1 of each year, at a rate of 2.50% per year. | ||
Convertible senior notes, interest payment commencement date | Aug. 1, 2015 | ||
Convertible senior notes, maturity date | Feb. 1, 2022 | ||
Convertible senior notes, stated interest rate | 2.50% | ||
Convertible senior notes, conversion share per 1000 principal amount | 93.2945 | ||
Convertible senior notes, initial conversion price | $ 10.72 | ||
Repurchase price of principal amount | 100.00% | ||
Common stock issuable upon conversion of notes | 10,728,867 | ||
Debt issuance cost | $ 568,000 | $ 568,000 |
Non-Cash Stock-Based Compensati
Non-Cash Stock-Based Compensation (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Non-cash stock-based compensation | $ 3,196 | $ 2,425 | $ 5,867 | $ 5,109 |
Research and development | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Non-cash stock-based compensation | 747 | 622 | 1,129 | 1,324 |
Selling, general and administrative | ||||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||||
Non-cash stock-based compensation | $ 2,449 | $ 1,803 | $ 4,738 | $ 3,785 |
Stockholders Equity - Additiona
Stockholders Equity - Additional Information (Detail) - shares | 6 Months Ended | |||
Jun. 30, 2015 | May. 19, 2015 | May. 18, 2015 | Dec. 31, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Common stock, shares authorized | 200,000,000 | 200,000,000 | 100,000,000 | 100,000,000 |
Employee Stock Purchase Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Equity Incentive Plans, shares available for future grant | 4,000,000 | |||
Maximum | Employee Stock Purchase Plan | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Equity Incentive Plans, exercise prices as a percentage of fair value of common stock | 85.00% | |||
Equity Incentive Plans, exercise prices as a percentage of fair value of common stock on purchase date | 85.00% | |||
Equity Incentive Plans, shares authorized for issuance | 4,000,000 |