Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2016 | Apr. 29, 2016 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | CNCE | |
Entity Registrant Name | CONCERT PHARMACEUTICALS, INC. | |
Entity Central Index Key | 1,367,920 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 22,216,718 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 37,821 | $ 92,510 |
Investments, available for sale | 89,898 | 49,680 |
Interest receivable | 379 | 181 |
Accounts receivable | 152 | 70 |
Prepaid expenses and other current assets | 2,305 | 1,667 |
Total current assets | 130,555 | 144,108 |
Property and equipment, net | 2,248 | 2,346 |
Restricted cash | 400 | 400 |
Other assets | 92 | 78 |
Total assets | 133,295 | 146,932 |
Current liabilities: | ||
Accounts payable | 771 | 501 |
Accrued expenses and other liabilities | 3,450 | 4,772 |
Income taxes payable | 0 | 75 |
Deferred revenue, current portion | 1,250 | 1,279 |
Total current liabilities | 5,471 | 6,627 |
Deferred revenue, net of current portion | 8,885 | 8,891 |
Deferred lease incentive, net of current portion | 493 | 573 |
Deferred rent, net of current portion | 184 | 206 |
Total liabilities | $ 15,033 | $ 16,297 |
Commitments | ||
Stockholders’ equity: | ||
Preferred stock, $0.001 par value per share; 5,000,000 shares authorized; no shares issued and outstanding in 2016 and 2015, respectively | ||
Common stock, $0.001 par value per share; 100,000,000 shares authorized; 22,210,797 and 22,166,803 shares issued and 22,209,160 and 22,165,166 outstanding in 2016 and 2015, respectively | $ 22 | $ 22 |
Additional paid-in capital | 253,251 | 251,793 |
Accumulated other comprehensive income (loss) | 31 | (18) |
Accumulated deficit | (135,042) | (121,162) |
Total stockholders’ equity | 118,262 | 130,635 |
Total liabilities and stockholders’ equity | $ 133,295 | $ 146,932 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Parenthetical) - $ / shares | Mar. 31, 2016 | Dec. 31, 2015 |
Statement of Financial Position [Abstract] | ||
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 | 100,000,000 | 100,000,000 |
Common stock, shares issued | 22,210,797 | 22,209,160 |
Common stock, shares outstanding | 22,166,803 | 22,165,166 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Revenue: | ||
License and research and development revenue | $ 56 | $ 1,306 |
Total revenue | 56 | 1,306 |
Operating expenses: | ||
Research and development | 10,453 | 6,944 |
General and administrative | 3,577 | 3,233 |
Total operating expenses | 14,030 | 10,177 |
Loss from operations | (13,974) | (8,871) |
Investment income | 94 | 17 |
Interest and other expense | 0 | (148) |
Net loss | (13,880) | (9,002) |
Other comprehensive income (loss): | ||
Unrealized gain on investments | 49 | 20 |
Comprehensive loss | $ (13,831) | $ (8,982) |
Net loss per share applicable to common stockholders — basic and diluted, in dollars per share | $ (0.63) | $ (0.48) |
Weighted-average number of common shares used in net loss per share applicable to common stockholders— basic and diluted (in shares) | 22,198 | 18,726 |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Cash Flows - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Operating activities | ||
Net loss | $ (13,880) | $ (9,002) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 210 | 183 |
Stock-based compensation expense | 1,282 | 646 |
Accretion of premiums and discounts on investments | 134 | 181 |
Amortization of discount on loan payable | 0 | 25 |
Amortization of deferred financing costs | 0 | 9 |
Amortization of deferred lease incentive | (78) | (76) |
Loss on disposal of asset | 2 | 0 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (82) | 898 |
Interest receivable | (198) | 64 |
Prepaid expenses and other current assets | (638) | (1,045) |
Other assets | (14) | 8 |
Accounts payable | 270 | 444 |
Accrued expenses and other liabilities | (1,359) | (2,598) |
Income taxes payable | (75) | 0 |
Deferred rent | (9) | (20) |
Deferred revenue | (35) | (753) |
Net cash used in operating activities | (14,470) | (11,036) |
Investing activities | ||
Purchases of property and equipment | (92) | (150) |
Purchases of investments | (71,898) | (5,576) |
Maturities of investments | 31,595 | 22,000 |
Net cash (used in) provided by investing activities | (40,395) | 16,274 |
Financing activities | ||
Principal payments on loan payable | 0 | (2,089) |
Proceeds from sale of common stock, net of underwriting discounts and commissions | 0 | 46,995 |
Proceeds from exercise of stock options | 176 | 310 |
Payment of public offering costs | 0 | (34) |
Net cash provided by financing activities | 176 | 45,182 |
Net (decrease) increase in cash and cash equivalents | (54,689) | 50,420 |
Cash and cash equivalents at beginning of period | 92,510 | 13,396 |
Cash and cash equivalents at end of period | 37,821 | 63,816 |
Supplemental cash flow information: | ||
Cash paid for interest | 0 | 138 |
Cash paid for income taxes | 85 | 0 |
Purchases of property and equipment unpaid at period end | 64 | 92 |
Public offering costs incurred but unpaid at period end | $ 0 | $ 276 |
Nature of Business
Nature of Business | 3 Months Ended |
Mar. 31, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Nature of Business | Nature of Business Concert Pharmaceuticals, Inc., or Concert or the Company, was incorporated on April 12, 2006 as a Delaware corporation with operations based in Lexington, Massachusetts. The Company is a clinical stage biopharmaceutical company that applies its extensive knowledge of deuterium chemistry to discover and develop novel small molecule drugs. The Company’s approach starts with approved drugs, advanced clinical candidates or previously studied compounds that the Company believes can be improved with deuterium substitution to provide better pharmacokinetic or metabolic properties, enhancing clinical safety, tolerability or efficacy. The Company believes this approach may enable drug discovery and clinical development that is more efficient and less expensive than conventional small molecule drug research and development. The Company’s pipeline includes multiple clinical-stage candidates and a number of preclinical compounds that it is currently assessing. In March 2015, the Company sold 3,300,000 shares of common stock in a public offering at a price to the public of $15.15 per share, resulting in net proceeds to the Company of approximately $46.7 million after deducting underwriting discounts and commissions and offering expenses. In June 2015, the Company received a one-time payment of $50.2 million from Auspex Pharmaceuticals, Inc. pursuant to a patent assignment agreement between Concert and Auspex. Concert became eligible to receive the payment due to a change of control of Auspex, which was acquired by Teva Pharmaceuticals Industries Ltd. in May 2015. For additional details regarding the one-time payment received from Auspex, refer to the Company's Annual Report on Form 10-K for the fiscal year ended December 31, 2015, which was filed with the Securities and Exchange Commission on March 1, 2016. The Company had cash and cash equivalents and investments of $127.7 million at March 31, 2016. The Company believes that its cash and cash equivalents and investments at March 31, 2016 will be sufficient to allow the Company to fund its current operating plan for at least the next twelve months. The Company may pursue additional cash resources through public or private financings and by establishing collaborations with or licensing its technology to other companies. Unless otherwise indicated, all amounts are in thousands except share and per share amounts. |
Basis of Presentation and Signi
Basis of Presentation and Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2016 | |
Accounting Policies [Abstract] | |
Basis of Presentation and Significant Accounting Policies | Basis of Presentation and Significant Accounting Policies Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring accruals and revisions of estimates, considered necessary for a fair presentation of the condensed consolidated financial statements have been included. Interim results for the three months ended March 31, 2016 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2016 or any other future period. The accompanying condensed consolidated financial statements reflect the accounts of Concert and its subsidiaries. All intercompany transactions between the Company and its subsidiary have been eliminated. Management has determined that the Company operates in one segment: the development of pharmaceutical products on its own behalf or in collaboration with others. The information included in this quarterly report on Form 10-Q should be read in conjunction with the Company’s consolidated financial statements and the accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 filed with the Securities and Exchange Commission on March 1, 2016. Use of Estimates and Summary of Significant Accounting Policies The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that can affect the reported amounts of assets, liabilities, equity, revenue and expenses and the disclosure of contingent assets and liabilities. In preparing the condensed consolidated financial statements, management used estimates in the following areas, among others: revenue recognition for multiple-element revenue arrangements, stock-based compensation expense; and accrued expenses. Actual results could differ from those estimates. There have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standard Board, or FASB, issued Accounting Standards Update, or ASU, No. 2014-09, Revenue from Contracts with Customers (Topic 606), or ASU 2014-09, which stipulates that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve this core principle, ASU 2014-09 provides that an entity should apply the following steps: (1) identify the contract(s) with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when (or as) the entity satisfies a performance obligation. This update will be effective for the Company beginning in the first quarter of fiscal 2018 as a result of the FASB’s one year deferral of the effective date for this standard. Early adoption is permitted, however not before the original effective date of annual periods beginning on or after December 15, 2016. The Company is currently assessing the impact of this ASU on its financial statements. In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties About an Entity’s Ability to Continue as a Going Concern, or ASU 2014-15 ASU 2014-15 amends FASB Accounting Standards Codification, or ASC, 205-40, Presentation of Financial Statements – Going Concern, by providing guidance on determining when and how reporting entities must disclose going-concern uncertainties in their financial statements, including requiring management to perform interim and annual assessments of an entity’s ability to continue as a going concern within one year of the date of issuance of the entity’s financial statements and providing certain disclosures if there is substantial doubt about the entity’s ability to continue as a going concern. ASU 2014-15 will be effective for the Company’s fiscal year 2016 and for interim periods beginning in the first quarter of fiscal 2017. If this standard had been adopted as of March 31, 2016, the Company believes that it would have concluded there was not substantial doubt about its ability to continue as a going concern. However, the Company's disclosures in future periods may be affected by the adoption of this accounting standard. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), or ASU 2016-02. ASU 2016-02 requires lessees to recognize assets and liabilities on the balance sheet for the rights and obligations created by all leases with terms of more than 12 months. ASU 2016-02 also will require certain qualitative and quantitative disclosures designed to give financial statement users information on the amount, timing, and uncertainty of cash flows arising from leases. ASU 2016-02 will be effective for the Company on January 1, 2019, with early adoption permitted. The Company is currently evaluating the impact ASU 2016-02 will have on its financial statements. In March 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation-Improvements to Employee Share-Based Payment Accounting, or ASU 2016-09. This update simplifies several aspects of the accounting for share-based compensation arrangements, including accounting for income taxes, forfeitures and statutory tax withholding requirements as well as classification of related amounts on the statement of cash flows. The ASU is effective for fiscal years beginning after December 15, 2016, with early adoption permitted. The Company is currently evaluating the effect that the updated standard will have on its financial statements and related disclosures. |
Fair Value Measurements
Fair Value Measurements | 3 Months Ended |
Mar. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair Value Measurements | Fair Value Measurements The Company has certain financial assets and liabilities that are recorded at fair value which have been classified as Level 1, 2 or 3 within the fair value hierarchy as described in the accounting standards for fair value measurements: • Level 1—quoted prices for identical instruments in active markets; • Level 2—quoted prices for similar instruments in active markets, quoted prices for identical or similar instruments in markets that are not active, and model-derived valuations in which all significant inputs and significant value drivers are observable in active markets; and • Level 3—valuations derived from valuation techniques in which one or more significant value drivers are unobservable. The tables below present information about the Company’s financial assets and liabilities that are measured and carried at fair value as of March 31, 2016 and December 31, 2015 (in thousands) and indicate the level within the fair value hierarchy where each measurement is classified. Level 1 Level 2 Level 3 Total (in thousands) March 31, 2016 Cash equivalents: Money market funds $ 24,831 $ — $ — $ 24,831 U.S. Treasury obligations 5,000 — — 5,000 Government agency securities 6,008 — — 6,008 Investments, available for sale: U.S. Treasury obligations 32,159 — — 32,159 Government agency securities 37,915 19,824 — 57,739 Total $ 105,913 $ 19,824 $ — $ 125,737 Level 1 Level 2 Level 3 Total December 31, 2015 Cash equivalents: Money market funds $ 52,221 $ — $ — $ 52,221 U.S. Treasury obligations 5,001 — — 5,001 Government agency securities — 34,390 — 34,390 Investments, available for sale: U.S. Treasury obligations 9,781 — — 9,781 Government agency securities 19,578 20,321 — 39,899 Total $ 86,581 $ 54,711 $ — $ 141,292 |
Cash, Cash Equivalents and Inve
Cash, Cash Equivalents and Investments, Available for Sale | 3 Months Ended |
Mar. 31, 2016 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents and Investments, Available for Sale | Cash, Cash Equivalents and Investments Cash equivalents include all highly liquid investments maturing within 90 days from the date of purchase. Investments consist of securities with original maturities greater than 90 days when purchased. The Company classifies these investments as available-for-sale and records them at fair value in the accompanying consolidated balance sheets. Unrealized gains or losses are included in accumulated other comprehensive income (loss). Premiums or discounts from par value are amortized to investment income over the life of the underlying investment. Cash, cash equivalents and investments, available for sale included the following at March 31, 2016 and December 31, 2015: Average maturity Amortized cost Unrealized gains Unrealized losses Fair value (in thousands) March 31, 2016 Cash $ 1,982 $ — $ — $ 1,982 Money market funds 24,831 — — 24,831 U.S. Treasury obligations 30 days 5,000 — — 5,000 Government agency securities 15 days 6,008 — — 6,008 Cash and cash equivalents $ 37,821 $ — $ — $ 37,821 U.S. Treasury obligations 204 days $ 32,145 15 (1 ) $ 32,159 Government agency securities 108 days 57,722 18 (1 ) 57,739 Investments, available for sale $ 89,867 $ 33 $ (2 ) $ 89,898 Average maturity Amortized cost Unrealized gains Unrealized losses Fair value December 31, 2015 Cash $ 898 $ — $ — $ 898 Money market funds 52,221 — — 52,221 U.S. Treasury obligations 31 days 5,002 — (1 ) 5,001 Government agency securities 41 days 34,389 1 — 34,390 Cash and cash equivalents $ 92,510 $ 1 $ (1 ) $ 92,510 U.S. Treasury obligations 42 days $ 9,785 $ — $ (4 ) $ 9,781 Government agency securities 104 days 39,913 1 (15 ) 39,899 Investments, available for sale $ 49,698 $ 1 $ (19 ) $ 49,680 Although available to be sold to meet operating needs or otherwise, securities are generally held through maturity. The cost of securities sold is determined based on the specific identification method for purposes of recording realized gains and losses. During 2016 and 2015, there were no realized gains or losses on sales of investments, and no investments were adjusted for other than temporary declines in fair value. |
Accrued Expenses and Other Liab
Accrued Expenses and Other Liabilities | 3 Months Ended |
Mar. 31, 2016 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Liabilities | Accrued Expenses and Other Liabilities Accrued expenses and other liabilities consisted of the following: March 31, December 31, Accrued professional fees and other $ 573 $ 732 Employee compensation and benefits 631 2,503 Research and development expenses 1,865 1,171 Deferred lease incentive, current portion 317 315 Deferred rent, current portion 64 51 $ 3,450 $ 4,772 |
Collaborations
Collaborations | 3 Months Ended |
Mar. 31, 2016 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Collaborations | Collaborations Celgene In April 2013, the Company entered into a master development and license agreement with Celgene Corporation and Celgene International Sàrl, referred to together as Celgene, which is primarily focused on the research, development and commercialization of specified deuterated compounds targeting inflammation or cancer. The initial program in the collaboration is CTP-730, a deuterium-modified analog of apremilast. Celgene has an exclusive worldwide license to develop, manufacture and commercialize deuterated analogs of apremilast and certain close chemical derivatives thereof. The Company further granted Celgene licenses with respect to two additional programs and an option with respect to a third additional program. The Company was responsible for conducting and funding research and early development activities for the CTP-730 program at its own expense pursuant to mutually agreed upon development plans. This included the completion of single and multiple ascending dose Phase 1 clinical trials in 2015. Under the terms of the agreement, the Company received a non-refundable upfront payment of $35.0 million . In October 2015, the Company achieved an $8.0 million development milestone upon completion of Phase 1 clinical evaluation of CTP-730. In addition, the Company is eligible to earn an additional $15.0 million development milestone payment, up to $247.5 million in regulatory milestone payments and up to $50.0 million in sales-based milestone payments related to products within the CTP-730 program. The next milestone payment the Company may be entitled to achieve under the CTP-730 program is $15.0 million related to the first dosing in a Phase 3 clinical trial or, if earlier, acceptance for filing of a NDA. If Celgene exercises its rights with respect to either of the two additional license programs, the Company will receive a license exercise fee for the applicable program of $30.0 million and will also be eligible to earn up to $23.0 million in development milestone payments and up to $247.5 million in regulatory milestone payments for that program. Additionally, with respect to one of the additional license programs, the Company is eligible to receive up to $100.0 million in milestone payments based on net sales of products, and with respect to the other additional license program, the Company is eligible to receive up to $50.0 million in milestone payments based on net sales of products. If Celgene exercises its option with respect to the option program, in respect of a compound to be identified at a later time, the Company will receive an option exercise fee of $10.0 million and will be eligible to earn up to $23.0 million in development milestone payments and up to $247.5 million in regulatory milestone payments. In addition, with respect to each program, Celgene is required to pay the Company royalties on worldwide net sales of each licensed product at defined percentages ranging from the mid-single digits to low double digits below 20% . The royalty rate is reduced on a country-by-country basis during any period within the royalty term when there is no patent claim or regulatory exclusivity covering the licensed product in the particular country. The Company’s arrangement with Celgene contains the following deliverables: (i) an exclusive worldwide license to develop, manufacture and commercialize deuterated analogs of a selected compound related to the CTP-730 program, or the License Deliverable, (ii) obligations to perform research and development services associated with the CTP-730 program, or the R&D Services Deliverable, (iii) obligation to supply preclinical and clinical trial material related to the CTP-730 program, or the Supply Deliverable, (iv) participation on the JSC during the term of the CTP-730 program, or the JSC Deliverable, (v) significant and incremental discount related to the first additional license program for which the non-deuterated compound has been selected, or the First Discount Deliverable and (vi) significant and incremental discount related to the second additional license program for which the non-deuterated compound has been selected, or the Second Discount Deliverable. Allocable arrangement consideration at inception was limited to the $35.0 million non-refundable upfront payment. The Company allocated the arrangement consideration for the collaboration among the separate units of accounting using the relative selling price method. The arrangement consideration allocated to the License Deliverable was recognized upon delivery, amounts allocated to the R&D Services Deliverable and Supply Deliverable are recognized under the proportional performance method over the expected period of performance, or 45 months and the amount allocated to the JSC Deliverable is recognized ratably over the expected period of performance, or 45 months . During the three months ended March 31, 2016 and 2015, the Company recognized revenue of $8 thousand and $0.6 million for the R&D Services Deliverable and $20 thousand and $0.1 million for the Supply Deliverable, respectively. The revenue was classified as license and research and development revenue in the accompanying condensed consolidated statement of operations and comprehensive loss. As of March 31, 2016, there was $7.3 million of deferred revenue related to the Company’s collaboration with Celgene, $1.2 million of which relates to the Supply Deliverable and R&D Services Deliverable and was classified as a current liability and $6.1 million of which relates to the First and Second Discount Deliverables and was classified as a noncurrent liability, in the accompanying condensed consolidated balance sheet. Jazz Pharmaceuticals In February 2013, the Company entered into a development and license agreement with Jazz Pharmaceuticals, Inc., or Jazz Pharmaceuticals, to research, develop and commercialize deuterated sodium oxybate analogs, or D-SXB. Jazz Pharmaceuticals is focusing on one analog, designated as JZP-386. Under the terms of the agreement, the Company granted Jazz Pharmaceuticals an exclusive, worldwide, royalty-bearing license under intellectual property controlled by the Company to develop, manufacture and commercialize D-SXB products including, but not limited to, JZP-386. The Company, together with Jazz Pharmaceuticals, has conducted certain development activities for Phase 1 clinical trials with respect to JZP-386 pursuant to an agreed upon development plan. The Company was responsible under the development plan for conducting the Phase 1 clinical trials with respect to JZP-386. The Company’s obligations to conduct further development activities are subject to mutual agreement. Jazz Pharmaceuticals has assumed all manufacturing and development responsibilities relating to JZP-386. Pursuant to the agreement, the Company’s costs for activities under the development plan were reimbursed by Jazz Pharmaceuticals, except for the costs of a Phase 1 clinical trial that was conducted in the first half of 2015, which was shared between Jazz Pharmaceuticals and the Company. Under the agreement, the Company received a non-refundable upfront payment of $4.0 million and is eligible to earn an aggregate of up to $8.0 million in development milestone payments, up to $35.0 million in regulatory milestone payments and up to $70.0 million in sales-based milestone payments based on net product sales of licensed products. The next milestone payment that the Company may be entitled to receive is $4.0 million related to initiation of the first Phase 2 clinical trial of JZP-386. In addition, Jazz Pharmaceuticals is required to pay the Company royalties at defined percentages ranging from the mid-single digits to low double digits below 20% on worldwide net sales of licensed products. The royalty rate is lowered, on a country-by-country basis, under certain circumstances as specified in the agreement. For the three months ended March 31, 2016 and 2015, the Company recognized revenue of $34 thousand and $0.4 million related to the performance of development support services, respectively. Avanir In February 2012, the Company entered into a development and license agreement with Avanir Pharmaceuticals, Inc., or Avanir, under which the Company granted Avanir an exclusive worldwide license to develop, manufacture and commercialize deuterated dextromethorphan containing products. Avanir is currently focused on developing AVP-786, which is a combination of a deuterated analog of dextromethorphan and a low dose of quinidine. Subsequent to the Company’s development and license agreement, Avanir was acquired by Otsuka Pharmaceutical Co., Ltd. and it is now a wholly owned subsidiary of Otsuka America, Inc. Since June 2012, Avanir has elected to conduct all research and development activities, including manufacturing activities; however, the Company has received intellectual property cost reimbursements. Under the agreement, the Company received a non-refundable upfront payment of $2.0 million and has received milestone payments of $6.0 million . The Company is also eligible to earn, with respect to licensed products comprising a combination of deuterated dextromethorphan and quinidine, up to $37.0 million in regulatory and commercial launch milestone payments, of which $21.5 million in development and regulatory milestone payments are associated with the first indication, and up to $125.0 million in sales-based milestone payments. The next milestone payments that the Company may be entitled to receive are $5.0 million upon acceptance for filing of a New Drug Application, or NDA, and $3.0 million upon acceptance for filing of a Marketing Authorization Application, or MAA, related to AVP-786. In addition, the Company is eligible for higher development milestones, up to an additional $43.0 million , for licensed products that do not require quinidine. Avanir is currently developing deuterated dextromethorphan only in combination with quinidine. Avanir also is required to pay the Company royalties at defined percentages ranging from the mid-single digits to low double digits below 20% on net sales of licensed products on a country-by-country basis. The royalty rate is reduced, on a country-by-country basis, during any period within the royalty term when there is no patent claim covering the licensed product in the particular country. |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation The Company’s equity incentive plans provide for the issuance of a variety of stock-based awards, including incentive stock options, nonstatutory stock options and awards of stock, to directors, officers and employees of the Company, as well as consultants and advisors to the Company. To date, the Company has granted awards solely in the form of stock options, which have generally been granted with an exercise price equal to the fair value of the underlying common stock on the date of grant, expire no later than ten years from the date of grant and generally vest over three or four years. Effective January 1, 2016, an additional 886,606 shares were added to the Company’s 2014 Stock Incentive Plan, or the 2014 Plan, for future issuance pursuant to the terms of the 2014 Plan. As of March 31, 2016, there were 1,805,286 shares of common stock available for future award grants under the 2014 Plan. Total stock-based compensation expense related to all stock-based awards recognized in the condensed consolidated statements of operations and comprehensive loss consisted of: Three Months Ended 2016 2015 Research and development $ 553 $ 325 General and administrative 729 321 Total stock-based compensation expense $ 1,282 $ 646 Stock Options Stock options are valued using the Black-Scholes-Merton option valuation model and compensation cost is recognized based on such fair value over the period of vesting. The weighted average fair value of options granted in the three months ended March 31, 2016 and 2015 reflect the following weighted-average assumptions: Three Months Ended 2016 2015 Expected volatility 78.34 % 73.11 % Expected term 6.0 years 6.0 years Risk-free interest rate 1.38 % 1.54 % Expected dividend yield — % — % For the three months ended March 31, 2016 and 2015, expected volatility was estimated using the historical volatility of the common stock of a group of similar companies that were publicly traded. The Company will continue to apply this process until a sufficient amount of historical information regarding the volatility of its own stock price becomes available. The following table provides certain information related to the Company's outstanding stock options: Three Months Ended March 31, 2016 2015 (in thousands, except per share data) Weighted average fair value of options granted, per option $ 11.19 $ 9.34 Aggregate grant date fair value of options vested during the year $ 1,032 $ 423 Total cash received from exercises of stock options $ 176 $ 310 Total intrinsic value of stock options exercised $ 496 $ 2,086 The following is a summary of stock option activity for the three months ended March 31, 2016: Number of Option Shares Weighted Average Exercise Price per Share Weighted Average Remaining Contractual Term Aggregate Intrinsic Value (In years) (In thousands) Outstanding at December 31, 2015 2,244,177 $ 8.10 Granted 759,500 $ 16.55 Exercised (43,994 ) $ 4.00 Forfeited or expired (838 ) $ 13.57 Outstanding at March 31, 2016 2,958,845 $ 10.33 7.35 $ 12,758 Exercisable at March 31, 2016 1,401,787 $ 6.45 5.61 $ 10,323 Vested and expected to vest at March 31, 2016 (1) 2,819,857 $ 10.12 7.26 $ 12,591 (1) This represents the number of vested stock option shares as of March 31, 2016, plus the number of unvested stock option shares that the Company estimated as of March 31, 2016 would vest, based on the unvested stock option shares at March 31, 2016 and an estimated forfeiture rate of 6% . As of March 31, 2016, there was $13.8 million of unrecognized compensation cost related to stock options that are expected to vest. These costs are expected to be recognized over a weighted average remaining vesting period of 2.9 years . |
Earnings (Loss) Per Share
Earnings (Loss) Per Share | 3 Months Ended |
Mar. 31, 2016 | |
Earnings Per Share [Abstract] | |
Earnings (Loss) Per Share | Earnings (Loss) Per Share Basic net earnings (loss) per common share is calculated by dividing net earnings (loss) allocable to common stockholders by the weighted-average common shares outstanding during the period, without consideration of common stock equivalents. Diluted net earnings per share is calculated by adjusting the weighted-average shares outstanding for the dilutive effect of common stock equivalents, including stock options and warrants, outstanding for the period as determined using the treasury stock method. For purposes of the diluted net loss per share calculation, common stock equivalents are excluded from the calculation because their effect would be anti-dilutive. Therefore, basic and diluted net loss per share applicable to common stockholders is the same for periods with a net loss. Three Months Ended March 31, 2016 2015 (in thousands, expect per share amounts) Numerator: Net loss applicable to common stockholders -basic and diluted $ (13,880 ) $ (9,002 ) Denominator: Weighted average shares outstanding - basic 22,198 18,726 Dilutive stock options — — Dilutive warrants — — Weighted average shares outstanding - diluted 22,198 18,726 Net loss per share applicable to common stockholders - basic and diluted $ (0.63 ) $ (0.48 ) Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share: Stock options 767 1,116 Warrants 71 71 |
Income Taxes
Income Taxes | 3 Months Ended |
Mar. 31, 2016 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes Deferred tax assets and deferred tax liabilities are recognized based on temporary differences between the financial reporting and tax basis of assets and liabilities using statutory rates. A valuation allowance is recorded against deferred tax assets if it is more likely than not that some or all of the deferred tax assets will not be realized. The Company records a provision or benefit for income taxes on ordinary pre-tax income or loss based on its estimated effective tax rate for the year. As of March 31, 2016, the Company forecast an ordinary pre-tax loss for the year ended December 31, 2016 and, since it maintains a full valuation allowance on its deferred tax assets, the Company did not record an income tax benefit for the three months ended March 31, 2016. |
Basis of Presentation and Sig15
Basis of Presentation and Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2016 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements have been prepared in accordance with generally accepted accounting principles for interim financial information and with the instructions to Form 10-Q and Article 10 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by generally accepted accounting principles for complete financial statements. In the opinion of management, all adjustments, consisting of normal recurring accruals and revisions of estimates, considered necessary for a fair presentation of the condensed consolidated financial statements have been included. Interim results for the three months ended March 31, 2016 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2016 or any other future period. The accompanying condensed consolidated financial statements reflect the accounts of Concert and its subsidiaries. All intercompany transactions between the Company and its subsidiary have been eliminated. Management has determined that the Company operates in one segment: the development of pharmaceutical products on its own behalf or in collaboration with others. The information included in this quarterly report on Form 10-Q should be read in conjunction with the Company’s consolidated financial statements and the accompanying notes included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2015 filed with the Securities and Exchange Commission on March 1, 2016. |
Use of Estimates and Summary of Significant Accounting Policies | Use of Estimates and Summary of Significant Accounting Policies The preparation of condensed consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that can affect the reported amounts of assets, liabilities, equity, revenue and expenses and the disclosure of contingent assets and liabilities. In preparing the condensed consolidated financial statements, management used estimates in the following areas, among others: revenue recognition for multiple-element revenue arrangements, stock-based compensation expense; and accrued expenses. Actual results could differ from those estimates. There have been no material changes to the significant accounting policies previously disclosed in the Company’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standard Board, or FASB, issued Accounting Standards Update, or ASU, No. 2014-09, Revenue from Contracts with Customers (Topic 606), or ASU 2014-09, which stipulates that an entity should recognize revenue to depict the transfer of promised goods or services to customers in an amount that reflects the consideration to which the entity expects to be entitled in exchange for those goods or services. To achieve this core principle, ASU 2014-09 provides that an entity should apply the following steps: (1) identify the contract(s) with a customer, (2) identify the performance obligations in the contract, (3) determine the transaction price, (4) allocate the transaction price to the performance obligations in the contract and (5) recognize revenue when (or as) the entity satisfies a performance obligation. This update will be effective for the Company beginning in the first quarter of fiscal 2018 as a result of the FASB’s one year deferral of the effective date for this standard. Early adoption is permitted, however not before the original effective date of annual periods beginning on or after December 15, 2016. The Company is currently assessing the impact of this ASU on its financial statements. In August 2014, the FASB issued ASU No. 2014-15, Disclosure of Uncertainties About an Entity’s Ability to Continue as a Going Concern, or ASU 2014-15 ASU 2014-15 amends FASB Accounting Standards Codification, or ASC, 205-40, Presentation of Financial Statements – Going Concern, by providing guidance on determining when and how reporting entities must disclose going-concern uncertainties in their financial statements, including requiring management to perform interim and annual assessments of an entity’s ability to continue as a going concern within one year of the date of issuance of the entity’s financial statements and providing certain disclosures if there is substantial doubt about the entity’s ability to continue as a going concern. ASU 2014-15 will be effective for the Company’s fiscal year 2016 and for interim periods beginning in the first quarter of fiscal 2017. If this standard had been adopted as of March 31, 2016, the Company believes that it would have concluded there was not substantial doubt about its ability to continue as a going concern. However, the Company's disclosures in future periods may be affected by the adoption of this accounting standard. In February 2016, the FASB issued ASU No. 2016-02, Leases (Topic 842), or ASU 2016-02. ASU 2016-02 requires lessees to recognize assets and liabilities on the balance sheet for the rights and obligations created by all leases with terms of more than 12 months. ASU 2016-02 also will require certain qualitative and quantitative disclosures designed to give financial statement users information on the amount, timing, and uncertainty of cash flows arising from leases. ASU 2016-02 will be effective for the Company on January 1, 2019, with early adoption permitted. The Company is currently evaluating the impact ASU 2016-02 will have on its financial statements. In March 2016, the FASB issued ASU No. 2016-09, Compensation-Stock Compensation-Improvements to Employee Share-Based Payment Accounting, or ASU 2016-09. This update simplifies several aspects of the accounting for share-based compensation arrangements, including accounting for income taxes, forfeitures and statutory tax withholding requirements as well as classification of related amounts on the statement of cash flows. The ASU is effective for fiscal years beginning after December 15, 2016, with early adoption permitted. The Company is currently evaluating the effect that the updated standard will have on its financial statements and related disclosures. |
Fair Value Measurements (Tables
Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Fair Value Disclosures [Abstract] | |
Financial Assets and Liabilities Recognized at Fair Value | The tables below present information about the Company’s financial assets and liabilities that are measured and carried at fair value as of March 31, 2016 and December 31, 2015 (in thousands) and indicate the level within the fair value hierarchy where each measurement is classified. Level 1 Level 2 Level 3 Total (in thousands) March 31, 2016 Cash equivalents: Money market funds $ 24,831 $ — $ — $ 24,831 U.S. Treasury obligations 5,000 — — 5,000 Government agency securities 6,008 — — 6,008 Investments, available for sale: U.S. Treasury obligations 32,159 — — 32,159 Government agency securities 37,915 19,824 — 57,739 Total $ 105,913 $ 19,824 $ — $ 125,737 Level 1 Level 2 Level 3 Total December 31, 2015 Cash equivalents: Money market funds $ 52,221 $ — $ — $ 52,221 U.S. Treasury obligations 5,001 — — 5,001 Government agency securities — 34,390 — 34,390 Investments, available for sale: U.S. Treasury obligations 9,781 — — 9,781 Government agency securities 19,578 20,321 — 39,899 Total $ 86,581 $ 54,711 $ — $ 141,292 |
Cash, Cash Equivalents and In17
Cash, Cash Equivalents and Investments, Available for Sale (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents and Investments, Available for Sale | Cash, cash equivalents and investments, available for sale included the following at March 31, 2016 and December 31, 2015: Average maturity Amortized cost Unrealized gains Unrealized losses Fair value (in thousands) March 31, 2016 Cash $ 1,982 $ — $ — $ 1,982 Money market funds 24,831 — — 24,831 U.S. Treasury obligations 30 days 5,000 — — 5,000 Government agency securities 15 days 6,008 — — 6,008 Cash and cash equivalents $ 37,821 $ — $ — $ 37,821 U.S. Treasury obligations 204 days $ 32,145 15 (1 ) $ 32,159 Government agency securities 108 days 57,722 18 (1 ) 57,739 Investments, available for sale $ 89,867 $ 33 $ (2 ) $ 89,898 Average maturity Amortized cost Unrealized gains Unrealized losses Fair value December 31, 2015 Cash $ 898 $ — $ — $ 898 Money market funds 52,221 — — 52,221 U.S. Treasury obligations 31 days 5,002 — (1 ) 5,001 Government agency securities 41 days 34,389 1 — 34,390 Cash and cash equivalents $ 92,510 $ 1 $ (1 ) $ 92,510 U.S. Treasury obligations 42 days $ 9,785 $ — $ (4 ) $ 9,781 Government agency securities 104 days 39,913 1 (15 ) 39,899 Investments, available for sale $ 49,698 $ 1 $ (19 ) $ 49,680 |
Accrued Expenses and Other Li18
Accrued Expenses and Other Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Liabilities | Accrued expenses and other liabilities consisted of the following: March 31, December 31, Accrued professional fees and other $ 573 $ 732 Employee compensation and benefits 631 2,503 Research and development expenses 1,865 1,171 Deferred lease incentive, current portion 317 315 Deferred rent, current portion 64 51 $ 3,450 $ 4,772 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation Expense Related to All Stock Based Awards Recognized in Statements of Operations and Comprehensive Income (Loss) | Total stock-based compensation expense related to all stock-based awards recognized in the condensed consolidated statements of operations and comprehensive loss consisted of: Three Months Ended 2016 2015 Research and development $ 553 $ 325 General and administrative 729 321 Total stock-based compensation expense $ 1,282 $ 646 |
Estimated Weighted-Average Assumptions of Options Granted | The weighted average fair value of options granted in the three months ended March 31, 2016 and 2015 reflect the following weighted-average assumptions: Three Months Ended 2016 2015 Expected volatility 78.34 % 73.11 % Expected term 6.0 years 6.0 years Risk-free interest rate 1.38 % 1.54 % Expected dividend yield — % — % |
Certain Information Related to Outstanding Stock Options | The following table provides certain information related to the Company's outstanding stock options: Three Months Ended March 31, 2016 2015 (in thousands, except per share data) Weighted average fair value of options granted, per option $ 11.19 $ 9.34 Aggregate grant date fair value of options vested during the year $ 1,032 $ 423 Total cash received from exercises of stock options $ 176 $ 310 Total intrinsic value of stock options exercised $ 496 $ 2,086 |
Summary of Stock Option Activity | The following is a summary of stock option activity for the three months ended March 31, 2016: Number of Option Shares Weighted Average Exercise Price per Share Weighted Average Remaining Contractual Term Aggregate Intrinsic Value (In years) (In thousands) Outstanding at December 31, 2015 2,244,177 $ 8.10 Granted 759,500 $ 16.55 Exercised (43,994 ) $ 4.00 Forfeited or expired (838 ) $ 13.57 Outstanding at March 31, 2016 2,958,845 $ 10.33 7.35 $ 12,758 Exercisable at March 31, 2016 1,401,787 $ 6.45 5.61 $ 10,323 Vested and expected to vest at March 31, 2016 (1) 2,819,857 $ 10.12 7.26 $ 12,591 (1) This represents the number of vested stock option shares as of March 31, 2016, plus the number of unvested stock option shares that the Company estimated as of March 31, 2016 would vest, based on the unvested stock option shares at March 31, 2016 and an estimated forfeiture rate of 6% . |
Earnings (Loss) Per Share (Tabl
Earnings (Loss) Per Share (Tables) | 3 Months Ended |
Mar. 31, 2016 | |
Earnings Per Share [Abstract] | |
Computation of Basic and Diluted Earnings (Loss) Per Share | Three Months Ended March 31, 2016 2015 (in thousands, expect per share amounts) Numerator: Net loss applicable to common stockholders -basic and diluted $ (13,880 ) $ (9,002 ) Denominator: Weighted average shares outstanding - basic 22,198 18,726 Dilutive stock options — — Dilutive warrants — — Weighted average shares outstanding - diluted 22,198 18,726 Net loss per share applicable to common stockholders - basic and diluted $ (0.63 ) $ (0.48 ) Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share: Stock options 767 1,116 Warrants 71 71 |
Nature of Business - Additional
Nature of Business - Additional Information (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 3 Months Ended | |
Jun. 30, 2015 | Mar. 31, 2015 | Mar. 31, 2016 | |
Subsidiary, Sale of Stock [Line Items] | |||
Cash and cash equivalents and investments | $ 127.7 | ||
Period of sufficiency of cash resources to fund operating plan | 12 months | ||
Concert Auspex Patent Agreement | |||
Subsidiary, Sale of Stock [Line Items] | |||
Payment received under patent assignment agreement | $ 50.2 | ||
IPO | |||
Subsidiary, Sale of Stock [Line Items] | |||
Common stock, issued | 3,300,000 | ||
Common stock price per share | $ 15.15 | ||
Net proceeds of IPO | $ 46.7 |
Basis of Presentation and Sig22
Basis of Presentation and Significant Accounting Policies - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2016Segment | |
Accounting Policies [Abstract] | |
Number of segments | 1 |
Fair Value Measurements - Finan
Fair Value Measurements - Financial Assets and Liabilities Recognized at Fair Value (Detail) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Investments with Maturity Period One | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale Securities | $ 37,821 | $ 92,510 |
Investments with Maturity Period Two | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale Securities | 89,898 | 49,680 |
Fair Value, Measurements, Recurring | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets at fair value | 125,737 | 141,292 |
Fair Value, Measurements, Recurring | Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets at fair value | 105,913 | 86,581 |
Fair Value, Measurements, Recurring | Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Financial assets at fair value | 19,824 | 54,711 |
Fair Value, Measurements, Recurring | U.S. Treasury obligations | Investments with Maturity Period One | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 5,000 | 5,001 |
Fair Value, Measurements, Recurring | U.S. Treasury obligations | Investments with Maturity Period Two | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale Securities | 32,159 | 9,781 |
Fair Value, Measurements, Recurring | U.S. Treasury obligations | Level 1 | Investments with Maturity Period One | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 5,000 | 5,001 |
Fair Value, Measurements, Recurring | U.S. Treasury obligations | Level 1 | Investments with Maturity Period Two | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale Securities | 32,159 | 9,781 |
Fair Value, Measurements, Recurring | Government agency securities | Investments with Maturity Period One | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 6,008 | 34,390 |
Fair Value, Measurements, Recurring | Government agency securities | Investments with Maturity Period Two | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale Securities | 57,739 | 39,899 |
Fair Value, Measurements, Recurring | Government agency securities | Level 1 | Investments with Maturity Period One | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 6,008 | |
Fair Value, Measurements, Recurring | Government agency securities | Level 1 | Investments with Maturity Period Two | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale Securities | 37,915 | 19,578 |
Fair Value, Measurements, Recurring | Government agency securities | Level 2 | Investments with Maturity Period One | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 0 | 34,390 |
Fair Value, Measurements, Recurring | Government agency securities | Level 2 | Investments with Maturity Period Two | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Available-for-sale Securities | 19,824 | 20,321 |
Money market funds | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 24,831 | 52,221 |
Money market funds | Fair Value, Measurements, Recurring | Investments with Maturity Period One | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 24,831 | 52,221 |
Money market funds | Fair Value, Measurements, Recurring | Level 1 | Investments with Maturity Period One | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 24,831 | $ 52,221 |
Cash, Cash Equivalents and In24
Cash, Cash Equivalents and Investments, Available for Sale - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2016 | Dec. 31, 2015 | |
Cash and Cash Equivalents [Abstract] | ||
Cash equivalents, liquid investments maturity period | 90 days | |
Realized gains or losses on sales of investments | $ 0 | $ 0 |
Other than temporary impairment losses, investments | $ 0 | $ 0 |
Cash, Cash Equivalents and In25
Cash, Cash Equivalents and Investments, Available for Sale (Detail) - USD ($) $ in Thousands | 3 Months Ended | 12 Months Ended | ||
Mar. 31, 2016 | Dec. 31, 2015 | Mar. 31, 2015 | Dec. 31, 2014 | |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Amortized cost, Cash and cash equivalents | $ 37,821 | $ 92,510 | $ 63,816 | $ 13,396 |
Investments with Maturity Period One | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Amortized cost, Investments available for sale | 37,821 | 92,510 | ||
Unrealized gains | 0 | 1 | ||
Unrealized losses | 0 | (1) | ||
Available-for-sale Securities | 37,821 | 92,510 | ||
Investments with Maturity Period Two | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Amortized cost, Investments available for sale | 89,867 | 49,698 | ||
Unrealized gains | 33 | 1 | ||
Unrealized losses | (2) | (19) | ||
Available-for-sale Securities | 89,898 | 49,680 | ||
Cash | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Amortized cost, Cash and cash equivalents | 1,982 | 898 | ||
Fair value, Cash and cash equivalent | 1,982 | 898 | ||
Money market funds | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Amortized cost, Cash and cash equivalents | 24,831 | 52,221 | ||
Fair value, Cash and cash equivalent | $ 24,831 | $ 52,221 | ||
U.S. Treasury obligations | Investments with Maturity Period One | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Average maturity | 30 days | 31 days | ||
Amortized cost, Investments available for sale | $ 5,000 | $ 5,002 | ||
Unrealized gains | 0 | 0 | ||
Unrealized losses | 0 | (1) | ||
Available-for-sale Securities | $ 5,000 | $ 5,001 | ||
U.S. Treasury obligations | Investments with Maturity Period Two | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Average maturity | 204 days | 42 days | ||
Amortized cost, Investments available for sale | $ 32,145 | $ 9,785 | ||
Unrealized gains | 15 | 0 | ||
Unrealized losses | (1) | (4) | ||
Available-for-sale Securities | $ 32,159 | $ 9,781 | ||
Government agency securities | Investments with Maturity Period One | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Average maturity | 15 days | 41 days | ||
Amortized cost, Investments available for sale | $ 6,008 | $ 34,389 | ||
Unrealized gains | 0 | 1 | ||
Unrealized losses | 0 | 0 | ||
Available-for-sale Securities | $ 6,008 | $ 34,390 | ||
Government agency securities | Investments with Maturity Period Two | ||||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||||
Average maturity | 108 days | 104 days | ||
Amortized cost, Investments available for sale | $ 57,722 | $ 39,913 | ||
Unrealized gains | 18 | 1 | ||
Unrealized losses | (1) | (15) | ||
Available-for-sale Securities | $ 57,739 | $ 39,899 |
Accrued Expenses and Other Li26
Accrued Expenses and Other Liabilities - Accrued Expenses and Other Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2016 | Dec. 31, 2015 |
Payables and Accruals [Abstract] | ||
Accrued professional fees and other | $ 573 | $ 732 |
Employee compensation and benefits | 631 | 2,503 |
Research and development expenses | 1,865 | 1,171 |
Deferred lease incentive, current portion | 317 | 315 |
Deferred rent, current portion | 64 | 51 |
Accrued expenses and other liabilities | $ 3,450 | $ 4,772 |
Collaborations - Celgene - Addi
Collaborations - Celgene - Additional Information (Detail) | 1 Months Ended | 3 Months Ended | |||
Apr. 30, 2013USD ($)Licensed_ProgramOption | Mar. 31, 2016USD ($) | Mar. 31, 2015USD ($) | Dec. 31, 2015USD ($) | Oct. 30, 2015USD ($) | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Deferred revenue, current portion | $ 1,250,000 | $ 1,279,000 | |||
License, research and development revenue | 56,000 | $ 1,306,000 | |||
Deferred revenue, noncurrent | 8,885,000 | $ 8,891,000 | |||
Celgene | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Number of additional license program | Licensed_Program | 2 | ||||
Deferred revenue, current portion | 1,200,000 | ||||
Percentage of royalty on net sales required to pay under the agreement | 20.00% | ||||
Arrangement consideration allocated to the License Deliverable, recognition period | 45 months | ||||
Deferred revenue | 7,300,000 | ||||
Deferred revenue, noncurrent | 6,100,000 | ||||
Celgene | Maximum | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Non-refundable upfront payment | $ 35,000,000 | ||||
Celgene | License Exercise Fee | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Number of options for providing license program | Option | 1 | ||||
Celgene | If Celgene Exercises its Option With Respect to the Option Program | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Deferred revenue, current portion | $ 10,000,000 | ||||
Celgene | If Celgene Exercises its Option With Respect to the Option Program | Development Milestone | Maximum | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Eligible payments receivable | 23,000,000 | ||||
Celgene | If Celgene Exercises its Option With Respect to the Option Program | Regulatory Milestones | Maximum | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Eligible payments receivable | 247,500,000 | ||||
Celgene | If Celgene Exercises its Rights With Respect to Either of the Two Additional License Programs | Sales-based Milestone | Maximum | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Eligible payments receivable | 100,000,000 | ||||
Celgene | If Celgene Exercises its Rights With Respect to Either of the Two Additional License Programs | Development Milestone | Maximum | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Eligible payments receivable | 23,000,000 | ||||
Celgene | If Celgene Exercises its Rights With Respect to Either of the Two Additional License Programs | Regulatory Milestones | Maximum | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Eligible payments receivable | $ 247,500,000 | ||||
Celgene | If Celgene Exercises its Rights With Respect to Either of the Two Additional License Programs | License Exercise Fee | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Number of options for providing license program | Option | 2 | ||||
Deferred revenue, current portion | $ 30,000,000 | ||||
Celgene | One of the Other Additional License Programs | Sales-based Milestone | Maximum | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Eligible payments receivable | 50,000,000 | ||||
Celgene | R&D Services Deliverable | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
License, research and development revenue | 0 | 600,000 | |||
Celgene | Supply Deliverable | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
License, research and development revenue | $ 0 | $ 100,000 | |||
Celgene | CTP-730 Program | Non-refundable Upfront Payment Arrangement | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Deferred revenue, payment received | 35,000,000 | ||||
Celgene | CTP-730 Program | Sales-based Milestone | Maximum | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Eligible payments receivable | 50,000,000 | ||||
Celgene | CTP-730 Program | Development Milestone | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Eligible payments receivable | $ 8,000,000 | ||||
Celgene | CTP-730 Program | Regulatory Milestones | Maximum | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Eligible payments receivable | 247,500,000 | ||||
Celgene | CTP-730 Program | If Celgene Exercises its Option With Respect to the Option Program | Development Milestone | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Eligible payments receivable | 15,000,000 | ||||
Celgene | Collaborative Arrangement, Product | CTP-730 Program | Development Milestone | Maximum | |||||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||||
Eligible payments receivable | $ 15,000,000 |
Collaborations - Jazz Pharmaceu
Collaborations - Jazz Pharmaceuticals - Additional Information (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | |
Feb. 28, 2013 | Mar. 31, 2016 | Mar. 31, 2015 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
License, research and development revenue | $ 56,000 | $ 1,306,000 | |
Jazz Pharmaceuticals | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Percentage of royalty on net sales required to pay under the agreement | 20.00% | ||
Jazz Pharmaceuticals | Non-refundable Upfront Payment Arrangement | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Deferred revenue, payment received | $ 4,000,000 | ||
Jazz Pharmaceuticals | Regulatory Milestones | Maximum | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Eligible payments receivable | 35,000,000 | ||
Jazz Pharmaceuticals | Sales-based Milestone | Maximum | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Eligible payments receivable | 70,000,000 | ||
Jazz Pharmaceuticals | Development Support Services | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
License, research and development revenue | $ 34,000 | $ 400,000 | |
Jazz Pharmaceuticals | JZP 386 | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Eligible payments receivable | 4,000,000 | ||
Jazz Pharmaceuticals | Collaborative Arrangement, Co-promotion | Development Milestone | Maximum | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Eligible payments receivable | $ 8,000,000 |
Collaborations - Avanir - Addit
Collaborations - Avanir - Additional Information (Detail) - Avanir Pharmaceuticals - USD ($) | 1 Months Ended | ||
Feb. 29, 2012 | Mar. 31, 2016 | Apr. 30, 2013 | |
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Eligible payments receivable | $ 6,000,000 | ||
Non-refundable Upfront Payment Arrangement | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Eligible payments receivable | $ 2,000,000 | ||
Regulatory and Commercial Launch Milestone | Maximum | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Eligible payments receivable | 37,000,000 | ||
Development Milestone | Maximum | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Eligible payments receivable | 21,500,000 | ||
Sales-based Milestone | Maximum | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Eligible payments receivable | $ 125,000,000 | ||
Collaborative Arrangement, Product | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Percentage of royalty on net sales required to pay under the agreement | 20.00% | ||
Collaborative Arrangement, Product | Licensed Product | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Eligible payments receivable | $ 43,000,000 | ||
Collaborative Arrangement, Product | AVP-786 Program | Development Milestone | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Eligible payments receivable | $ 5,000,000 | ||
Collaborative Arrangement, Co-promotion | AVP-786 Program | Development Milestone | |||
Collaborative Arrangements and Non-collaborative Arrangement Transactions [Line Items] | |||
Eligible payments receivable | $ 3,000,000 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) $ in Millions | Jan. 01, 2016 | Mar. 31, 2016 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Award plan modification, description and terms | To date, the Company has granted awards solely in the form of stock options, which have generally been granted with an exercise price equal to the fair value of the underlying common stock on the date of grant, expire no later than ten years from the date of grant and generally vest over three or four years. | |
Estimated forfeiture rate | 6.00% | |
Total unrecognized compensation cost related to unvested options | $ 13.8 | |
Total unrecognized compensation cost related to unvested options, weighted-average recognition period | 2 years 11 months | |
2014 Stock Incentive Plan | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Additional shares issued under the plan | 886,606 | |
Common stock available for future award grant (in shares) | 1,805,286 | |
Minimum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total cash received from exercises of stock options | 3 years | |
Maximum | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Awards expiration period | 10 years | |
Total cash received from exercises of stock options | 4 years |
Stock Based Compensation - Stoc
Stock Based Compensation - Stock-Based Compensation Expense Related to All Stock Based Awards Recognized in Statements of Operations and Comprehensive Income (Loss) (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 1,282 | $ 646 |
Research and development | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 553 | 325 |
General and administrative | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 729 | $ 321 |
Stock Based Compensation - Esti
Stock Based Compensation - Estimated Weighted-Average Assumptions of Options Granted (Detail) | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Expected volatility | 78.34% | 73.11% |
Expected term | 6 years | 6 years |
Risk-free interest rate | 1.38% | 1.54% |
Expected dividend yield | 0.00% | 0.00% |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Options (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Total cash received from exercises of stock options | $ 176 | $ 310 |
Stock Options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Weighted average fair value of options granted, per option (dollars per share) | $ 11.19 | $ 9.34 |
Aggregate grant date fair value of options vested during the year | $ 1,032 | $ 423 |
Total cash received from exercises of stock options | 176 | 310 |
Total intrinsic value of stock options exercised | $ 496 | $ 2,086 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) $ / shares in Units, $ in Thousands | 3 Months Ended |
Mar. 31, 2016USD ($)$ / sharesshares | |
Number of Option Shares | |
Number of options, Outstanding beginning balance (in shares) | shares | 2,244,177 |
Number of options, Granted (in shares) | shares | 759,500 |
Number of options, Exercised (in shares) | shares | (43,994) |
Number of options, Forfeited or expired (in shares) | shares | (838) |
Number of options, Outstanding ending balance (in shares) | shares | 2,958,845 |
Number of options, Exercisable (in shares) | shares | 1,401,787 |
Number of options, Vested and expected to vest (in shares) | shares | 2,819,857 |
Weighted Average Exercise Price per Share | |
Weighted average exercise price per share, Outstanding at beginning of year | $ / shares | $ 8.10 |
Weighted average exercise price per share, Granted | $ / shares | 16.55 |
Weighted average exercise price per share, Exercised | $ / shares | 4 |
Weighted average exercise price per share, Forfeited or expired | $ / shares | 13.57 |
Weighted average exercise price per share, Outstanding ending balance | $ / shares | 10.33 |
Weighted average exercise price per share, Exercisable | $ / shares | 6.45 |
Weighted average exercise price per share, Vested and expected to vest | $ / shares | $ 10.12 |
Weighted Average Remaining Contractual Term (In years) | |
Weighted average remaining contractual term, Outstanding | 7 years 4 months 6 days |
Weighted average remaining contractual term, Exercisable | 5 years 7 months 10 days |
Weighted average remaining contractual term, Vested and expected to vest | 7 years 3 months 4 days |
Aggregate Intrinsic Value | |
Aggregate Intrinsic Value, Outstanding | $ | $ 12,758 |
Aggregate Intrinsic Value, Exercisable | $ | 10,323 |
Aggregate Intrinsic Value, Vested and expected to vest | $ | $ 12,591 |
Earnings (Loss) Per Share - Com
Earnings (Loss) Per Share - Computation of Basic and Diluted Earnings (Loss) Per Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2016 | Mar. 31, 2015 | |
Numerator: | ||
Net loss applicable to common stockholders -basic and diluted | $ (13,880) | $ (9,002) |
Denominator: | ||
Weighted average shares outstanding - basic | 22,198 | 18,726 |
Dilutive stock options | 0 | 0 |
Dilutive warrants | 0 | 0 |
Weighted average shares outstanding - diluted | 22,198 | 18,726 |
Net loss per share applicable to common stockholders - basic and diluted | ||
Net loss per share applicable to common stockholders - basic and diluted | $ (0.63) | $ (0.48) |
Stock Options | ||
Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share: | ||
Common stock equivalents excluded from computation of earning per share | 767 | 1,116 |
Warrants | ||
Anti-dilutive potential common stock equivalents excluded from the calculation of net loss per share: | ||
Common stock equivalents excluded from computation of earning per share | 71 | 71 |