Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2017 | May 01, 2017 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | FLXN | |
Entity Registrant Name | Flexion Therapeutics Inc | |
Entity Central Index Key | 1,419,600 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 31,757,692 |
Condensed Consolidated Balance
Condensed Consolidated Balance Sheets (Unaudited) - USD ($) | Mar. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 42,921,000 | $ 30,915,000 |
Marketable securities | 142,896,000 | 174,688,000 |
Prepaid expenses and other current assets | 4,307,000 | 3,790,000 |
Total current assets | 190,124,000 | 209,393,000 |
Property and equipment, net | 11,841,000 | 11,664,000 |
Long-term investments | 1,728,000 | 4,725,000 |
Restricted cash | 600,000 | 480,000 |
Total assets | 204,293,000 | 226,262,000 |
Current liabilities: | ||
Accounts payable | 2,210,000 | 2,161,000 |
Accrued expenses and other current liabilities | 5,815,000 | 6,245,000 |
Current portion of long-term debt | 9,967,000 | 9,134,000 |
Total current liabilities | 17,992,000 | 17,540,000 |
Long-term debt | 19,908,000 | 21,399,000 |
Other long-term liabilities | 294,000 | 291,000 |
Total liabilities | 38,194,000 | 39,230,000 |
Commitments and contingencies | ||
Preferred Stock, $0.001 par value; 10,000,000 shares authorized at March 31, 2017 and December 31, 2016 and 0 shares issued and outstanding at March 31, 2017 and December 31, 2016 | ||
Stockholders’ equity: | ||
Common stock, $0.001 par value; 100,000,000 shares authorized; 31,752,692 and 31,667,469 shares issued and outstanding, at March 31, 2017 and December 31, 2016, respectively | 32,000 | 32,000 |
Additional paid-in capital | 401,694,000 | 398,757,000 |
Accumulated other comprehensive income | (62,000) | (71,000) |
Accumulated deficit | (235,565,000) | (211,686,000) |
Total stockholders’ equity | 166,099,000 | 187,032,000 |
Total liabilities and stockholders’ equity | $ 204,293,000 | $ 226,262,000 |
Condensed Consolidated Balance3
Condensed Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Mar. 31, 2017 | Dec. 31, 2016 |
Statement Of Financial Position [Abstract] | ||
Preferred stock, par value | $ 0.001 | $ 0.001 |
Preferred stock, shares authorized | 10,000,000 | 10,000,000 |
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 | 31,752,692 | 31,667,469 |
Common stock, shares outstanding | 31,752,692 | 31,667,469 |
Condensed Consolidated Statemen
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Operating expenses: | ||
Research and development | $ 10,756 | $ 11,981 |
General and administrative | 13,026 | 4,692 |
Total operating expenses | 23,782 | 16,673 |
Loss from operations | (23,782) | (16,673) |
Other income (expense): | ||
Interest income | 557 | 336 |
Interest expense | (632) | (276) |
Other income (expense), net | (22) | (202) |
Total other income (expense) | (97) | (142) |
Net loss | $ (23,879) | $ (16,815) |
Net loss per share basic and diluted | $ (0.75) | $ (0.78) |
Weighted average common shares outstanding, basic and diluted | 31,704 | 21,570 |
Other comprehensive (loss) income: | ||
Unrealized gains from available-for-sale securities, net of tax of $0 | $ 9 | $ (89) |
Total other comprehensive (loss) income | 9 | (89) |
Comprehensive loss | $ (23,870) | $ (16,904) |
Condensed Consolidated Stateme5
Condensed Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (Parenthetical) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Income Statement [Abstract] | ||
Unrealized gains from available-for-sale securities, tax | $ 0 | $ 0 |
Condensed Consolidated Stateme6
Condensed Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Cash flows from operating activities | ||
Net loss | $ (23,879,000) | $ (16,815,000) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation | 453,000 | 186,000 |
Stock-based compensation expense | 2,378,000 | 1,641,000 |
Amortization of premium (discount) on marketable securities | 155,000 | 196,000 |
Other non-cash charges | 11,000 | 9,000 |
Loss on disposal of fixed assets | 2,278,000 | |
Premium paid on securities purchased | (264,000) | |
Changes in operating assets and liabilities: | ||
Accounts receivable | 39,000 | |
Prepaid expenses, other current and long-term assets | (517,000) | (572,000) |
Accounts payable | 138,000 | (1,009,000) |
Accrued expenses and other current and long-term liabilities | 131,000 | 51,000 |
Net cash used in operating activities | (21,394,000) | (13,996,000) |
Cash flows from investing activities | ||
Purchases of property and equipment | (1,018,000) | (3,094,000) |
Change in restricted cash | (120,000) | |
Purchases of marketable securities | (25,450,000) | (3,006,000) |
Sale and redemption of marketable securities | 60,328,000 | 16,097,000 |
Discount received on securities purchased | 29,000 | |
Net cash provided by investing activities | 33,769,000 | 9,997,000 |
Cash flows from financing activities | ||
Payment of debt issuance costs | (42,000) | |
Payments on notes payable | (833,000) | |
Payments of public offering costs | (95,000) | |
Proceeds from the exercise of stock options | 559,000 | |
Net cash used in financing activities | (369,000) | (42,000) |
Net increase (decrease) in cash and cash equivalents | 12,006,000 | (4,041,000) |
Cash and cash equivalents at beginning of period | 30,915,000 | 62,944,000 |
Cash and cash equivalents at end of period | 42,921,000 | 58,903,000 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | 469,000 | 237,000 |
Supplemental disclosures of non-cash financing activities: | ||
Purchases of property and equipment in accounts payable and accrued expenses | $ 234,000 | $ 2,450,000 |
Overview and Nature of the Busi
Overview and Nature of the Business | 3 Months Ended |
Mar. 31, 2017 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Overview and Nature of the Business | 1. Overview and Nature of the Business Flexion Therapeutics, Inc. (“Flexion” or the “Company”) was incorporated under the laws of the state of Delaware on November 5, 2007. Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis (“OA”), a type of degenerative arthritis. In May 2016, the U.S Food and Drug Administration, or FDA, informed us that the safety and efficacy data from the registration program for Zilretta TM (FX006), our lead investigational product candidate, were acceptable to support the of a new drug application, or NDA. In December 2016, we submitted the NDA for Zilretta, and in February 2017, we announced that the FDA accepted the Zilretta NDA for filing and has established a user fee goal date under the Prescription Drug User Fee Act, or PDUFA, of October 6, 2017. The Company is subject to risks and uncertainties common to early-stage companies in the biopharmaceutical industry, including, but not limited to, new technological innovations, dependence on key personnel, protection of proprietary technology, compliance with government regulations, and the ability to secure additional capital to fund operations. Product candidates currently under development will require significant additional research and development efforts, including extensive preclinical and clinical testing and regulatory approval prior to commercialization. These efforts require significant amounts of additional capital, adequate personnel infrastructure and extensive compliance reporting capabilities. The Company’s product candidates are all in the development stage. There can be no assurance that development efforts, including clinical trials, will be successful. Even if the Company’s product development efforts are successful, it is uncertain when, if ever, the Company will realize significant revenue from product sales. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Presentation The accompanying condensed consolidated financial statements as of March 31, 2017, and for the three months ended March 31, 2017 and March 31, 2016, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (the “SEC”) and Generally Accepted Accounting Principles (“GAAP”) for consolidated financial information including the accounts of the Company and its wholly-owned subsidiary after elimination of all significant intercompany accounts and transactions. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, these condensed consolidated financial statements reflect all adjustments which are necessary for a fair statement of the Company’s financial position and results of its operations, as of and for the periods presented. These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 10, 2017. The information presented in the condensed consolidated financial statements and related notes as of March 31, 2017, and for the three months ended March 31, 2017 and March 31, 2016, is unaudited. The December 31, 2016 consolidated balance sheet included herein was derived from the audited financial statements as of that date, but does not include all disclosures, including notes, required by GAAP for complete financial statements. Interim results for the three months ended March 31, 2017 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2017, or any future period. The accompanying condensed consolidated financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company has incurred recurring losses and negative cash flows from operations. As of March 31, 2017 and December 31, 2016, the Company had cash, cash equivalents, marketable securities, and long-term investments of approximately $187,545,000 and $210,328,000, respectively. Management believes that current cash, cash equivalents and marketable securities on hand at March 31, 2017, together with the gross proceeds of our offering of approximately $201 million described in note twelve, should be sufficient to fund operations for at least the next twelve months from the date of these financial statements. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations, to fund increased research and development costs in order to seek approval for commercialization of its product candidates, and to successfully commercialize Zilretta, if approved. The Company’s failure to raise capital as and when needed would have a negative impact on its financial condition and its ability to pursue its business strategies as this capital is necessary for the Company to perform the research and development activities required to develop and seek approval for commercialization of the Company’s product candidates, to establish a commercial infrastructure in order to generate future revenue streams, and to successfully commercialize Zilretta, if approved. In May 2014, the FASB issued guidance which supersedes all existing revenue recognition requirements, including most industry-specific guidance. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the company expects to receive for those goods or services. In August 2015, the FASB issued Accounting Standards Update 2015-14, Revenue from Contracts with Customers: Deferral of the Effective Date. This latest standard defers the effective date of revenue standard ASU 2014-09 by one year and permits early adoption on a limited basis. Since the Company has not generated revenue to date, this guidance will only impact future periods, if any, when revenue is earned. This update will replace existing revenue recognition guidance under GAAP when it becomes effective for the Company beginning January 1, 2018, with early adoption permitted in the first quarter of 2017. The updated standard will permit the use of either the retrospective or cumulative effect transition method. The Company is adopting this guidance as of January 1, 2017 and is currently evaluating the potential impact that the adoption of this guidance may have on the Company’s future financial statements. In November 2015, the FASB issued ASU 2015-17, Income Taxes In February 2016, the FASB issued ASU 2016-02, Leases In March 2016, the FASB released ASU 2016-09, which amends ASC Topic 718, Compensation-Stock Compensation, to require changes to several areas of employee share-based payment accounting in an effort to simplify share-based reporting. The update revises requirements in the following areas: minimum statutory withholding, accounting for income taxes, forfeitures, and intrinsic value accounting for private entities. For public companies, the new rules will become effective for annual reporting periods beginning after December 15, 2016, and interim reporting periods within such annual period. In August 2016, the FASB issued ASU 2016-15, Statement of cash flows Consolidation The accompanying condensed consolidated financial statements include the Company and its wholly-owned subsidiary, Flexion Securities Corporation, Inc. The Company has eliminated all intercompany transactions for the three months ended March 31, 2017 and the year ended December 31, 2016. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and judgments that may affect the reported amounts of assets and liabilities, expenses and related disclosures. The Company bases estimates and judgments on historical experience and on various other factors that it believes to be reasonable under the circumstances. The most significant estimates in these condensed consolidated financial statements include useful lives with respect to long-lived assets, such as property and equipment and leasehold improvements, accounting for stock-based compensation, and accrued expenses, including clinical research costs. The Company’s actual results may differ from these estimates under different assumptions or conditions. The Company evaluates its estimates on an ongoing basis. Changes in estimates are reflected in reported results in the period in which they become known by the Company’s management. Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation and amortization expense is recognized using the straight-line method over the following estimated useful lives: Estimated Useful Life (Years) Computers, office equipment, and minor computer software 3 Computer software 7 Manufacturing equipment 7-10 Furniture and fixtures 5 Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the related asset. Costs of major additions and improvements are capitalized and depreciated on a straight-line basis over their useful lives. Repairs and maintenance costs are expensed as incurred. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is credited or charged to income. Property and equipment includes construction-in-progress that is not yet in service. Foreign Currencies The Company maintains a bank account denominated in British Pounds. All foreign currency payables and cash balances are measured at the applicable exchange rate at the end of the reporting period. All associated gains and losses from foreign currency transactions are reflected in the consolidated statements of operations. |
Fair Value of Financial Assets
Fair Value of Financial Assets and Liabilities | 3 Months Ended |
Mar. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets and Liabilities | 3. Fair Value of Financial Assets and Liabilities The following tables present information about the Company’s assets that are measured at fair value on a recurring basis as of March 31, 2017 and December 31, 2016 and indicate the level of the fair value hierarchy utilized to determine such fair value: Fair Value Measurements as of March 31, 2017 Using: (In thousands) Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ — $ 33,035 $ — $ 33,035 Marketable securities — 144,624 — 144,624 $ — $ 177,659 $ — $ 177,659 Fair Value Measurements as of December 31, 2016 Using: (In thousands) Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ — $ 9,830 $ — $ 9,830 Marketable securities — 179,414 — 179,414 $ — $ 189,244 $ — $ 189,244 As of March 31, 2017 and December 31, 2016, the Company’s cash equivalents that are invested in money market funds are valued based on Level 2 inputs. The Company measures the fair value of marketable securities, which consist of U.S. government obligations, commercial paper, and corporate bonds, using Level 2 inputs and primarily relies on quoted prices in active markets for similar marketable securities. During the three months ended March 31, 2017 and year ended December 31, 2016, there were no transfers between Level 1, Level 2, and Level 3. The carrying values of accounts receivable, prepaid expenses, other current assets, accounts payable and accrued expenses approximate their fair value due to the short-term nature of these balances. The Company has a term loan outstanding under its 2015 credit facility with MidCap Financial Funding XIII Trust and Silicon Valley Bank (the “2015 term loan”). The amount outstanding on its 2015 term loan is reported at its carrying value in the accompanying balance sheet. The Company determined the fair value of the 2015 term loan using an income approach that utilizes a discounted cash flow analysis based on current market interest rates for debt issuances with similar remaining years to maturity, adjusted for credit risk. The 2015 term loan was valued using Level 2 inputs as of March 31, 2017 and December 31, 2016. The result of the calculation yielded a fair value that approximates its carrying value. |
Marketable Securities
Marketable Securities | 3 Months Ended |
Mar. 31, 2017 | |
Investments Debt And Equity Securities [Abstract] | |
Marketable Securities | 4. Marketable Securities As of March 31, 2017 and December 31, 2016 the fair value of available-for-sale marketable securities by type of security was as follows: March 31, 2017 (In thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. Government obligations $ 58,012 $ — $ (26 ) $ 57,986 Commercial Paper 11,521 — — 11,521 Corporate bonds 75,153 5 (41 ) 75,117 $ 144,686 $ 5 $ (67 ) $ 144,624 December 31, 2016 (In thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Commercial Paper $ 7,769 $ — $ — $ 7,769 U.S. Government obligations 75,524 5 (12 ) 75,517 Corporate Bonds 96,193 1 (66 ) 96,128 $ 179,486 $ 6 $ (78 ) $ 179,414 As of March 31, 2017 and December 31, 2016, marketable securities consisted of approximately $142,896,000 and $174,688,000, respectively, of investments that mature within twelve months and approximately $1,728,000 and $4,725,000, respectively, of investments that mature within seventeen months. |
Property and Equipment, Net
Property and Equipment, Net | 3 Months Ended |
Mar. 31, 2017 | |
Property Plant And Equipment [Abstract] | |
Property and Equipment, Net | 5. Property and Equipment, Net Property and equipment, net, as of March 31, 2017 and December 31, 2016 consisted of the following: (In thousands) March 31, 2017 December 31, 2016 Manufacturing equipment $ 10,373 $ 10,099 Computers, office equipment, and minor computer software 659 573 Software 434 434 Construction—in progress 1,495 1,254 Furniture and fixtures 426 402 Leasehold improvements 283 278 13,670 13,040 Less: Accumulated depreciation (1,829 ) (1,376 ) Total property and equipment, net $ 11,841 $ 11,664 Depreciation expense for the three months ended March 31, 2017 and 2016 was approximately $453,000 and $186,000, respectively. No property and equipment was disposed of during the three months ended March 31, 2017. Construction in progress is primarily comprised of amounts related to equipment purchased for the Company’s portfolio expansion efforts. . |
Prepaid Expenses, Other Current
Prepaid Expenses, Other Current Assets, and Other Assets | 3 Months Ended |
Mar. 31, 2017 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Prepaid Expenses, Other Current Assets, and Other Assets | 6. Prepaid Expenses, Other Current Assets, and Other Assets Prepaid expenses and other current assets and other assets consisted of the following as of March 31, 2017 and December 31, 2016: March 31, December 31, 2017 2016 Prepaid expenses $ 1,578 $ 1,085 Security Deposits 2,099 2,099 Interest receivable on marketable securities 629 605 Employee advances 1 1 Total prepaid expenses and other current assets $ 4,307 $ 3,790 On December 1, 2016, Flexion paid a refundable NDA fee in the amount of $2,038,100 to the FDA. The Company evaluated each of the published criteria to qualify for a waiver and concluded all criteria were met and thus, obtaining a refund of the fee was probable. As of March 31, 2017 and December 31, 2016 the NDA fee was classified as a deposit in other current assets. On April 20, 2017 we were informed by the FDA that our NDA fee waiver was approved and the NDA fee would be refunded. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 3 Months Ended |
Mar. 31, 2017 | |
Payables And Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 7. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: (In thousands) March 31, 2017 December 31, 2016 Research and Development $ 1,140 $ 1,606 Payroll and other employee-related expenses 1,495 3,393 Professional services fees 2,146 926 Other 877 159 Interest expense 157 161 Total accrued expenses and other current liabilities $ 5,815 $ 6,245 |
Stock-Based Compensation
Stock-Based Compensation | 3 Months Ended |
Mar. 31, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 8. Stock-Based Compensation Stock Option Valuation The fair value of each of the Company’s stock option grants is estimated on the date of grant using the Black-Scholes option-pricing model. The Company currently estimates its expected stock volatility based on the historical volatility of its publicly-traded peer companies and expects to continue to do so until such time as it has adequate historical data regarding the volatility of its own publicly-traded stock price. The expected term of the Company’s stock options has been determined utilizing the “simplified” method for awards that qualify as “plain vanilla” options. The expected term of stock options granted to non-employees is equal to the contractual term of the option award. The risk-free interest rate is determined by reference to the U.S. Treasury yield curve in effect at the time of grant of the award for time periods approximately equal to the expected term of the award. Expected dividend yield is based on the fact that the Company has never paid cash dividends and does not expect to pay any cash dividends in the foreseeable future. The relevant data used to determine the value of the stock option grants for the three months ended March 31, 2017 and 2016 are as follows: Three months ended March 31, 2017 2016 Risk-free interest rates 2.23-2.29% 1.39-1.90% Expected dividend yield 0.00 % 0.00 % Expected term (in years) 6.0 6.1 Expected volatility 71.0-71.6% 83.8-84.1% The following table summarizes stock option activity for the three months ended March 31, 2017: (In thousands, except per share amounts) Shares Under Weighted Exercise Outstanding as of December 31, 2016 3,268 $ 14.84 Granted 280 19.74 Exercised (59 ) 9.47 Cancelled (23 ) 17.86 Outstanding as of March 31, 2017 3,466 $ 16.20 Options vested and expected to vest at March 31, 2017 3,466 $ 16.20 Options exercisable at March 31, 2017 1,337 $ 13.28 Approximately 189,300 outstanding restricted stock units (“RSUs”) are included in outstanding at March 31, 2017. The RSUs are performance based awards which will only begin vesting if and when a specified corporate performance based milestone is achieved. No outstanding performance awards were vested as of March 31, 2017. The aggregate intrinsic value of options is calculated as the difference between the exercise price of the options and the fair value of the Company’s common stock for those options that had exercise prices lower than the fair value of the Company’s common stock. A total of approximately 59,000 options, with an aggregate intrinsic value of approximately $666,000, were exercised during the three months ended March 31, 2017. At March 31, 2017 and 2016, there were options for the purchase of approximately 3,466,000 and 2,176,000 shares of the Company’s common stock outstanding, respectively, with a weighted average remaining contractual term of 8.2 years and with a weighted average exercise price of $16.20 and $15.16 per share, respectively. The weighted average grant date fair value of options granted during the three months ended March 31, 2017 and 2016 was $12.70 and $12.82, respectively. Stock-based Compensation The Company recorded stock-based compensation expense related to stock options for the three months ended March 31, 2017 and 2016 as follows: Three months ended March 31, (In thousands) 2017 2016 Research and development $ 879 $ 537 General and administrative 1,499 1,104 $ 2,378 $ 1,641 As of March 31, 2017 unrecognized stock-based compensation expense for stock options outstanding was approximately $22,088,000, which was expected to be recognized over a weighted average period of 3.0 years. Restricted Stock Units On January 4, 2016, the Company granted RSUs with performance and time-based vesting conditions to certain executives. These RSUs vest, and the underlying shares of common stock become deliverable, in the event the Company receives approval from the U.S. Food and Drug Administration (“FDA”) of a new drug application (“NDA”) for Zilretta (the “ ” |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2017 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 9. Net Loss per Share Basic and diluted net loss per share was calculated as follows for the three months ended March 31, 2017 and 2016: For the three months ended March 31, (In thousands) 2017 2016 Numerator: Net loss $ (23,879 ) $ (16,815 ) Net loss: $ (23,879 ) $ (16,815 ) Denominator: Weighted average common shares outstanding, basic and diluted 31,704 21,570 Net loss per share, basic and diluted $ (0.75 ) $ (0.78 ) Stock options and RSUs representing 3,504,000 and 2,378,000 weighted average shares of common stock were excluded from the computation of diluted net loss per share for the three months ended March 31, 2017 and 2016, respectively. These equity awards were excluded from the computations because the awards had an anti-dilutive impact due to the net loss incurred for those periods. |
Long-term Debt
Long-term Debt | 3 Months Ended |
Mar. 31, 2017 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 10. Long-term Debt On August 4, 2015, the Company entered into a credit and security agreement with MidCap Financial Trust, as agent, and MidCap Financial Funding XIII Trust and Silicon Valley Bank, as lenders, (the “Lenders”), to borrow up to $30,000,000 in term loans. The Company concurrently borrowed an initial term loan of $15,000,000 under the facility. The Company granted the Lenders a security interest in substantially all of its personal property, rights and assets, other than intellectual property, to secure the payment of all amounts owed under the credit facility. The Company agreed not to encumber any of its intellectual property without the Lenders’ prior written consent. The Company also agreed to maintain a balance in cash or cash equivalents at Silicon Valley Bank equal to the principal balance of the loan plus 5% for so long as the Company maintains any cash or cash equivalents in non-secured bank accounts. On July 22, 2016, the Company borrowed the remaining $15,000,000 under the credit and security agreement, in the form of a second term loan after receiving positive Phase 3 Zilretta clinical trial data meeting the trial’s primary endpoint and which is sufficient to file an NDA for Zilretta. The second term loan is subject to the same credit terms as the initial term loan under the facility. The credit and security agreement also contains certain representations, warranties, and covenants of the Company as well as a material adverse event clause. As of March 31, 2017, the Company was compliant with all covenants. Borrowings under the credit facility accrue interest monthly at a fixed interest rate of 6.25% per annum. Following an interest-only period of 19 months, principal will be due in 36 equal monthly installments commencing March 1, 2017 and ending February 1, 2020 (the “maturity date”). Upon the maturity date, the Company will be obligated to pay a final payment equal to 9% of the total principal amounts borrowed under the facility. The final payment amount is being accreted to the carrying value of the debt using the effective interest rate method. As of March 31, 2017, the carrying value of the term loan was approximately $29,875,000, of which $9,967,000 was due within 12 months and $19,908,000 was due in greater than 12 months. In connection with the credit and security agreement, the Company incurred debt issuance costs totaling approximately $150,000. These costs are being amortized over the estimated term of the debt using the straight-line method which approximates the effective interest method. The Company deducted the debt issuance costs from the carrying amount of the debt as of March 31, 2017 and December 31, 2016. As of March 31, 2017, annual principal and interest payments due under the 2015 term loan are as follows: Year Aggregate Minimum Payments (in thousands) 2017 $ 8,734 2018 11,082 2019 10,448 2020 4,383 Total $ 34,647 Less interest (2,072 ) Less final payment (2,700 ) Total $ 29,875 |
Foreign Currency
Foreign Currency | 3 Months Ended |
Mar. 31, 2017 | |
Foreign Currency [Abstract] | |
Foreign Currency | 11. Foreign Currency The Company maintains a bank account denominated in British Pounds. All foreign currency payables and cash balances are measured at the applicable exchange rate at the end of the reporting period. All associated gains and losses from foreign currency transactions are reflected in the consolidated statements of operations. Foreign currency losses for the three months ended March 31, 2017 were $0.1 million, compared to zero for the three months ended March 31, 2016. |
Subsequent Event
Subsequent Event | 3 Months Ended |
Mar. 31, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Event | 12. Subsequent Event On May 2, 2017, the Company completed an offering of convertible senior notes with a principal amount of $175 million maturing in 2024. In addition, the initial buyers exercised their option to purchase approximately $26 million of additional principal of the notes. The notes are general unsecured obligation of the Company and will accrue interest at a rate of 3.375 %, payable semiannually in arrears. The notes will be convertible, at the option of the holders if the Company’s stock maintains a price of 130% or greater of the conversion price for a specified period, into cash, shares of the Company’s common stock, or a combination of cash and shares, as determined by the Company. |
Summary of Significant Accoun19
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2017 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements as of March 31, 2017, and for the three months ended March 31, 2017 and March 31, 2016, have been prepared in accordance with the rules and regulations of the Securities and Exchange Commission (the “SEC”) and Generally Accepted Accounting Principles (“GAAP”) for consolidated financial information including the accounts of the Company and its wholly-owned subsidiary after elimination of all significant intercompany accounts and transactions. Accordingly, they do not include all of the information and footnotes required by GAAP for complete financial statements. In the opinion of management, these condensed consolidated financial statements reflect all adjustments which are necessary for a fair statement of the Company’s financial position and results of its operations, as of and for the periods presented. These condensed consolidated financial statements should be read in conjunction with the consolidated financial statements and notes thereto contained in the Company’s Annual Report on Form 10-K filed with the SEC on March 10, 2017. The information presented in the condensed consolidated financial statements and related notes as of March 31, 2017, and for the three months ended March 31, 2017 and March 31, 2016, is unaudited. The December 31, 2016 consolidated balance sheet included herein was derived from the audited financial statements as of that date, but does not include all disclosures, including notes, required by GAAP for complete financial statements. Interim results for the three months ended March 31, 2017 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2017, or any future period. The accompanying condensed consolidated financial statements have been prepared on a basis which assumes that the Company will continue as a going concern and which contemplates the realization of assets and satisfaction of liabilities and commitments in the normal course of business. The Company has incurred recurring losses and negative cash flows from operations. As of March 31, 2017 and December 31, 2016, the Company had cash, cash equivalents, marketable securities, and long-term investments of approximately $187,545,000 and $210,328,000, respectively. Management believes that current cash, cash equivalents and marketable securities on hand at March 31, 2017, together with the gross proceeds of our offering of approximately $201 million described in note twelve, should be sufficient to fund operations for at least the next twelve months from the date of these financial statements. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations, to fund increased research and development costs in order to seek approval for commercialization of its product candidates, and to successfully commercialize Zilretta, if approved. The Company’s failure to raise capital as and when needed would have a negative impact on its financial condition and its ability to pursue its business strategies as this capital is necessary for the Company to perform the research and development activities required to develop and seek approval for commercialization of the Company’s product candidates, to establish a commercial infrastructure in order to generate future revenue streams, and to successfully commercialize Zilretta, if approved. In May 2014, the FASB issued guidance which supersedes all existing revenue recognition requirements, including most industry-specific guidance. The new standard requires a company to recognize revenue when it transfers goods or services to customers in an amount that reflects the consideration that the company expects to receive for those goods or services. In August 2015, the FASB issued Accounting Standards Update 2015-14, Revenue from Contracts with Customers: Deferral of the Effective Date. This latest standard defers the effective date of revenue standard ASU 2014-09 by one year and permits early adoption on a limited basis. Since the Company has not generated revenue to date, this guidance will only impact future periods, if any, when revenue is earned. This update will replace existing revenue recognition guidance under GAAP when it becomes effective for the Company beginning January 1, 2018, with early adoption permitted in the first quarter of 2017. The updated standard will permit the use of either the retrospective or cumulative effect transition method. The Company is adopting this guidance as of January 1, 2017 and is currently evaluating the potential impact that the adoption of this guidance may have on the Company’s future financial statements. In November 2015, the FASB issued ASU 2015-17, Income Taxes In February 2016, the FASB issued ASU 2016-02, Leases In March 2016, the FASB released ASU 2016-09, which amends ASC Topic 718, Compensation-Stock Compensation, to require changes to several areas of employee share-based payment accounting in an effort to simplify share-based reporting. The update revises requirements in the following areas: minimum statutory withholding, accounting for income taxes, forfeitures, and intrinsic value accounting for private entities. For public companies, the new rules will become effective for annual reporting periods beginning after December 15, 2016, and interim reporting periods within such annual period. In August 2016, the FASB issued ASU 2016-15, Statement of cash flows |
Consolidation | Consolidation The accompanying condensed consolidated financial statements include the Company and its wholly-owned subsidiary, Flexion Securities Corporation, Inc. The Company has eliminated all intercompany transactions for the three months ended March 31, 2017 and the year ended December 31, 2016. |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and judgments that may affect the reported amounts of assets and liabilities, expenses and related disclosures. The Company bases estimates and judgments on historical experience and on various other factors that it believes to be reasonable under the circumstances. The most significant estimates in these condensed consolidated financial statements include useful lives with respect to long-lived assets, such as property and equipment and leasehold improvements, accounting for stock-based compensation, and accrued expenses, including clinical research costs. The Company’s actual results may differ from these estimates under different assumptions or conditions. The Company evaluates its estimates on an ongoing basis. Changes in estimates are reflected in reported results in the period in which they become known by the Company’s management. |
Property and Equipment | Property and Equipment Property and equipment are stated at cost less accumulated depreciation. Depreciation and amortization expense is recognized using the straight-line method over the following estimated useful lives: Estimated Useful Life (Years) Computers, office equipment, and minor computer software 3 Computer software 7 Manufacturing equipment 7-10 Furniture and fixtures 5 Leasehold improvements are amortized over the shorter of the lease term or the estimated useful life of the related asset. Costs of major additions and improvements are capitalized and depreciated on a straight-line basis over their useful lives. Repairs and maintenance costs are expensed as incurred. Upon retirement or sale, the cost of assets disposed of and the related accumulated depreciation are removed from the accounts and any resulting gain or loss is credited or charged to income. Property and equipment includes construction-in-progress that is not yet in service. |
Foreign Currencies | Foreign Currencies The Company maintains a bank account denominated in British Pounds. All foreign currency payables and cash balances are measured at the applicable exchange rate at the end of the reporting period. All associated gains and losses from foreign currency transactions are reflected in the consolidated statements of operations. |
Summary of Significant Accoun20
Summary of Significant Accounting Policies (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Accounting Policies [Abstract] | |
Property Plant and Equipment Estimated Useful Lives | Property and equipment are stated at cost less accumulated depreciation. Depreciation and amortization expense is recognized using the straight-line method over the following estimated useful lives: Estimated Useful Life (Years) Computers, office equipment, and minor computer software 3 Computer software 7 Manufacturing equipment 7-10 Furniture and fixtures 5 |
Fair Value of Financial Asset21
Fair Value of Financial Assets and Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets Measured at Fair Value on Recurring Basis | The following tables present information about the Company’s assets that are measured at fair value on a recurring basis as of March 31, 2017 and December 31, 2016 and indicate the level of the fair value hierarchy utilized to determine such fair value: Fair Value Measurements as of March 31, 2017 Using: (In thousands) Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ — $ 33,035 $ — $ 33,035 Marketable securities — 144,624 — 144,624 $ — $ 177,659 $ — $ 177,659 Fair Value Measurements as of December 31, 2016 Using: (In thousands) Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ — $ 9,830 $ — $ 9,830 Marketable securities — 179,414 — 179,414 $ — $ 189,244 $ — $ 189,244 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Investments Debt And Equity Securities [Abstract] | |
Summary of Fair Value of Available-for-Sale Marketable Securities by Type of Security | As of March 31, 2017 and December 31, 2016 the fair value of available-for-sale marketable securities by type of security was as follows: March 31, 2017 (In thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value U.S. Government obligations $ 58,012 $ — $ (26 ) $ 57,986 Commercial Paper 11,521 — — 11,521 Corporate bonds 75,153 5 (41 ) 75,117 $ 144,686 $ 5 $ (67 ) $ 144,624 December 31, 2016 (In thousands) Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Commercial Paper $ 7,769 $ — $ — $ 7,769 U.S. Government obligations 75,524 5 (12 ) 75,517 Corporate Bonds 96,193 1 (66 ) 96,128 $ 179,486 $ 6 $ (78 ) $ 179,414 |
Property and Equipment, Net (Ta
Property and Equipment, Net (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Property Plant And Equipment [Abstract] | |
Components of Property and Equipment | Property and equipment, net, as of March 31, 2017 and December 31, 2016 consisted of the following: (In thousands) March 31, 2017 December 31, 2016 Manufacturing equipment $ 10,373 $ 10,099 Computers, office equipment, and minor computer software 659 573 Software 434 434 Construction—in progress 1,495 1,254 Furniture and fixtures 426 402 Leasehold improvements 283 278 13,670 13,040 Less: Accumulated depreciation (1,829 ) (1,376 ) Total property and equipment, net $ 11,841 $ 11,664 |
Prepaid Expenses, Other Curre24
Prepaid Expenses, Other Current Assets, and Other Assets (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Prepaid Expenses and Other Current Assets and Other Assets | Prepaid expenses and other current assets and other assets consisted of the following as of March 31, 2017 and December 31, 2016: March 31, December 31, 2017 2016 Prepaid expenses $ 1,578 $ 1,085 Security Deposits 2,099 2,099 Interest receivable on marketable securities 629 605 Employee advances 1 1 Total prepaid expenses and other current assets $ 4,307 $ 3,790 |
Accrued Expenses and Other Cu25
Accrued Expenses and Other Current Liabilities (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Payables And Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following: (In thousands) March 31, 2017 December 31, 2016 Research and Development $ 1,140 $ 1,606 Payroll and other employee-related expenses 1,495 3,393 Professional services fees 2,146 926 Other 877 159 Interest expense 157 161 Total accrued expenses and other current liabilities $ 5,815 $ 6,245 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Schedule of Relevant Data Used to Estimate Fair Value of Stock Option Grants | The relevant data used to determine the value of the stock option grants for the three months ended March 31, 2017 and 2016 are as follows: Three months ended March 31, 2017 2016 Risk-free interest rates 2.23-2.29% 1.39-1.90% Expected dividend yield 0.00 % 0.00 % Expected term (in years) 6.0 6.1 Expected volatility 71.0-71.6% 83.8-84.1% |
Summary of Stock Option Activity | The following table summarizes stock option activity for the three months ended March 31, 2017: (In thousands, except per share amounts) Shares Under Weighted Exercise Outstanding as of December 31, 2016 3,268 $ 14.84 Granted 280 19.74 Exercised (59 ) 9.47 Cancelled (23 ) 17.86 Outstanding as of March 31, 2017 3,466 $ 16.20 Options vested and expected to vest at March 31, 2017 3,466 $ 16.20 Options exercisable at March 31, 2017 1,337 $ 13.28 |
Stock-Based Compensation Expense Related to Stock Options | The Company recorded stock-based compensation expense related to stock options for the three months ended March 31, 2017 and 2016 as follows: Three months ended March 31, (In thousands) 2017 2016 Research and development $ 879 $ 537 General and administrative 1,499 1,104 $ 2,378 $ 1,641 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Net Loss per Share | Basic and diluted net loss per share was calculated as follows for the three months ended March 31, 2017 and 2016: For the three months ended March 31, (In thousands) 2017 2016 Numerator: Net loss $ (23,879 ) $ (16,815 ) Net loss: $ (23,879 ) $ (16,815 ) Denominator: Weighted average common shares outstanding, basic and diluted 31,704 21,570 Net loss per share, basic and diluted $ (0.75 ) $ (0.78 ) |
Long-term Debt (Tables)
Long-term Debt (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Debt Disclosure [Abstract] | |
Schedule of Annual Principal and Interest Payments Due Under Term Loan | As of March 31, 2017, annual principal and interest payments due under the 2015 term loan are as follows: Year Aggregate Minimum Payments (in thousands) 2017 $ 8,734 2018 11,082 2019 10,448 2020 4,383 Total $ 34,647 Less interest (2,072 ) Less final payment (2,700 ) Total $ 29,875 |
Overview and Nature of the Bu29
Overview and Nature of the Business - Additional Information (Detail) | 3 Months Ended |
Mar. 31, 2017 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Incorporation date | Nov. 5, 2007 |
Summary of Significant Accoun30
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2017 | Dec. 31, 2016 | |
Accounting Policies [Abstract] | ||
Cash and cash equivalents and marketable securities | $ 187,545,000 | $ 210,328,000 |
Gross proceeds from offering of convertible senior notes | $ 201,000,000 |
Summary of Significant Accoun31
Summary of Significant Accounting Policies - Property Plant and Equipment Estimated Useful Lives (Detail) | 3 Months Ended |
Mar. 31, 2017 | |
Computers, Office Equipment, and Minor Computer Software [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life (Years) | 3 years |
Computer Software [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life (Years) | 7 years |
Manufacturing Equipment [Member] | Minimum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life (Years) | 7 years |
Manufacturing Equipment [Member] | Maximum [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life (Years) | 10 years |
Furniture and Fixtures [Member] | |
Property, Plant and Equipment [Line Items] | |
Estimated Useful Life (Years) | 5 years |
Fair Value of Financial Asset32
Fair Value of Financial Assets and Liabilities - Schedule of Assets Measured at Fair Value on Recurring Basis (Detail) - Fair Value Measurements, Recurring [Member] - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | $ 33,035 | $ 9,830 |
Marketable securities | 144,624 | 179,414 |
Assets, Total | 177,659 | 189,244 |
Level 2 [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 33,035 | 9,830 |
Marketable securities | 144,624 | 179,414 |
Assets, Total | $ 177,659 | $ 189,244 |
Fair Value of Financial Asset33
Fair Value of Financial Assets and Liabilities - Additional Information (Detail) - USD ($) | 3 Months Ended | 12 Months Ended |
Mar. 31, 2017 | Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | ||
Transfers between Level 1, Level 2 and Level 3 | $ 0 | $ 0 |
Marketable Securities - Summary
Marketable Securities - Summary of Fair Value of Available-for-Sale Marketable Securities by Type of Security (Detail) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 144,686 | $ 179,486 |
Gross Unrealized Gains | 5 | 6 |
Gross Unrealized Losses | (67) | (78) |
Fair Value | 144,624 | 179,414 |
U.S. Government Obligations [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 58,012 | 75,524 |
Gross Unrealized Gains | 5 | |
Gross Unrealized Losses | (26) | (12) |
Fair Value | 57,986 | 75,517 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 11,521 | 7,769 |
Fair Value | 11,521 | 7,769 |
Corporate Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 75,153 | 96,193 |
Gross Unrealized Gains | 5 | 1 |
Gross Unrealized Losses | (41) | (66) |
Fair Value | $ 75,117 | $ 96,128 |
Marketable Securities - Additio
Marketable Securities - Additional Information (Detail) - USD ($) | Mar. 31, 2017 | Dec. 31, 2016 |
Investments Debt And Equity Securities [Abstract] | ||
Marketable securities | $ 142,896,000 | $ 174,688,000 |
Marketable securities, noncurrent | $ 1,728,000 | $ 4,725,000 |
Property and Equipment, Net - C
Property and Equipment, Net - Components of Property and Equipment (Detail) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | $ 13,670 | $ 13,040 |
Less: Accumulated depreciation | (1,829) | (1,376) |
Total property and equipment, net | 11,841 | 11,664 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | 10,373 | 10,099 |
Construction-in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | 1,495 | 1,254 |
Computers, Office Equipment, and Minor Computer Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | 659 | 573 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | 426 | 402 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | 283 | 278 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | $ 434 | $ 434 |
Property and Equipment, Net - A
Property and Equipment, Net - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Property Plant And Equipment [Abstract] | ||
Depreciation | $ 453,000 | $ 186,000 |
Property and equipment disposals | $ 0 |
Prepaid Expenses, Other Curre38
Prepaid Expenses, Other Current Assets, and Other Assets - Prepaid Expenses and Other Current Assets and Other Assets (Detail) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | ||
Prepaid expenses | $ 1,578 | $ 1,085 |
Security Deposits | 2,099 | 2,099 |
Interest receivable on marketable securities | 629 | 605 |
Employee advances | 1 | 1 |
Total prepaid expenses and other current assets | $ 4,307 | $ 3,790 |
Prepaid Expenses, Other Curre39
Prepaid Expenses, Other Current Assets, and Other Assets - Additional Information (Detail) | Dec. 01, 2016USD ($) |
Deferred Costs Capitalized Prepaid And Other Assets Disclosure [Abstract] | |
Refundable NDA fee paid to FDA | $ 2,038,100 |
Accrued Expenses and Other Cu40
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Payables And Accruals [Abstract] | ||
Research and Development | $ 1,140 | $ 1,606 |
Payroll and other employee-related expenses | 1,495 | 3,393 |
Professional services fees | 2,146 | 926 |
Other | 877 | 159 |
Interest expense | 157 | 161 |
Total accrued expenses and other current liabilities | $ 5,815 | $ 6,245 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Relevant Data Used to Estimate Fair Value of Stock Option Grants (Detail) | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | ||
Risk-free interest rates, Minimum | 2.23% | 1.39% |
Risk-free interest rates, Maximum | 2.29% | 1.90% |
Expected dividend yield | 0.00% | 0.00% |
Expected term (in years) | 6 years | 6 years 1 month 6 days |
Expected volatility, Minimum | 71.00% | 83.80% |
Expected volatility, Maximum | 71.60% | 84.10% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) | 3 Months Ended |
Mar. 31, 2017$ / sharesshares | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Shares Issuable Under Options, Beginning balance | shares | 3,268,000 |
Shares Issuable Under Options, Granted | shares | 280,000 |
Shares Issuable Under Options, Exercised | shares | (59,000) |
Shares Issuable Under Options, Cancelled | shares | (23,000) |
Shares Issuable Under Options, Ending balance | shares | 3,466,000 |
Shares Issuable Under Options, Options vested and expected to vest at March 31, 2017 | shares | 3,466,000 |
Shares Issuable Under Options, Options exercisable at March 31, 2017 | shares | 1,337,000 |
Weighted Average Exercise Price, Beginning balance | $ / shares | $ 14.84 |
Weighted Average Exercise Price, Granted | $ / shares | 19.74 |
Weighted Average Exercise Price, Exercised | $ / shares | 9.47 |
Weighted Average Exercise Price, Cancelled | $ / shares | 17.86 |
Weighted Average Exercise Price, Ending balance | $ / shares | 16.20 |
Weighted Average Exercise Price, Options vested and expected to vest | $ / shares | 16.20 |
Weighted Average Exercise Price, Options exercisable | $ / shares | $ 13.28 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | Jan. 04, 2016 | Mar. 31, 2017 | Mar. 31, 2016 | Dec. 31, 2016 |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Number of options exercised | 59,000 | |||
Aggregate intrinsic value of stock options exercised | $ 666,000 | |||
Options to purchase common stock, outstanding | 3,466,000 | 2,176,000 | 3,268,000 | |
Weighted average remaining contractual term | 8 years 2 months 12 days | 8 years 2 months 12 days | ||
Weighted average exercise price | $ 16.20 | $ 15.16 | $ 14.84 | |
Weighted average grant date fair value of options granted | $ 12.70 | $ 12.82 | ||
Unrecognized stock-based compensation expense | $ 22,088,000 | |||
Unrecognized compensation costs, weighted-average recognition periods | 3 years | |||
Performance-Based Awards [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Aggregate number of outstanding restricted common stock units | 189,300 | |||
Performance based RSUs vested | 0 | |||
Restricted Stock Units (RSUs) [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Aggregate number of restricted common stock units granted under performance-based vesting | 189,300 | |||
Grant date fair value of restricted common stock units under performance-based vesting | $ 3,997,000 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation Expense Related to Stock Options (Detail) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 2,378 | $ 1,641 |
Research and Development [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | 879 | 537 |
General and Administrative [Member] | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock-based compensation expense | $ 1,499 | $ 1,104 |
Net Loss per Share - Schedule o
Net Loss per Share - Schedule of Basic and Diluted Net Loss per Share (Detail) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Numerator: | ||
Net loss | $ (23,879) | $ (16,815) |
Net loss: | $ (23,879) | $ (16,815) |
Denominator: | ||
Weighted average common shares outstanding, basic and diluted | 31,704 | 21,570 |
Net loss per share, basic and diluted | $ (0.75) | $ (0.78) |
Net Loss per Share - Additional
Net Loss per Share - Additional Information (Detail) - shares | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Stock Option and RSUs [Member] | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Anti-dilutive securities excluded from the computation of diluted net loss per share attributable to common shareholders | 3,504,000 | 2,378,000 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Detail) - USD ($) | Jul. 22, 2016 | Aug. 04, 2015 | Mar. 31, 2017 | Dec. 31, 2016 |
Debt Instrument [Line Items] | ||||
Carrying value of term loan | $ 29,875,000 | |||
Term loan due within 12 months | 9,967,000 | $ 9,134,000 | ||
Term loan due in greater than 12 months | $ 19,908,000 | $ 21,399,000 | ||
Mid Cap Financial Trust [Member] | 2015 Term Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Term loan, maximum borrowings | $ 30,000,000 | |||
Debt instrument description | The Company also agreed to maintain a balance in cash or cash equivalents at Silicon Valley Bank equal to the principal balance of the loan plus 5%. | |||
Debt instrument percentage of cash or cash equivalents addition to principal balance | 5.00% | |||
Debt instrument interest rate | 6.25% | |||
Term loan, first periodic payment date | Mar. 1, 2017 | |||
Term loan, last periodic payment date | Feb. 1, 2020 | |||
Interest on final payment | 9.00% | |||
Term loan, payment description | Interest-only period of 19 months, principal will be due in 36 equal monthly installments. | |||
Carrying value of term loan | $ 29,875,000 | |||
Term loan due within 12 months | 9,967,000 | |||
Term loan due in greater than 12 months | $ 19,908,000 | |||
Debt issuance costs | $ 150,000 | |||
Mid Cap Financial Trust [Member] | 2015 Term Loan [Member] | Interest-Only-Strip [Member] | ||||
Debt Instrument [Line Items] | ||||
Term loan, Interest payment period | 19 months | |||
Mid Cap Financial Trust [Member] | 2015 Term Loan [Member] | Principal-Only-Strip [Member] | ||||
Debt Instrument [Line Items] | ||||
Term loan, Interest payment period | 36 months | |||
Mid Cap Financial Trust [Member] | 2015 Term Loan [Member] | Initial Term Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Term loan, currently borrowed | $ 15,000,000 | |||
Mid Cap Financial Trust [Member] | 2015 Term Loan [Member] | Second Term Loan [Member] | ||||
Debt Instrument [Line Items] | ||||
Term loan remaining amount borrowed | $ 15,000,000 |
Long Term Debt - Schedule of An
Long Term Debt - Schedule of Annual Principal and Interest Payments Due Under Term Loan (Detail) $ in Thousands | Mar. 31, 2017USD ($) |
Long-term Debt, Fiscal Year Maturity [Abstract] | |
2,017 | $ 8,734 |
2,018 | 11,082 |
2,019 | 10,448 |
2,020 | 4,383 |
Total | 34,647 |
Less interest | (2,072) |
Less final payment | (2,700) |
Total | $ 29,875 |
Foreign Currency - Additional I
Foreign Currency - Additional Information (Detail) - USD ($) | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Foreign Currency [Abstract] | ||
Foreign currency losses | $ 100,000 | $ 0 |
Subsequent Event - Additional I
Subsequent Event - Additional Information (Detail) - Convertible Senior Notes [Member] - Subsequent Event [Member] | May 02, 2017USD ($) |
Subsequent Event [Line Items] | |
Debt instrument principal amount | $ 175,000,000 |
Debt instrument maturity period | 2,024 |
Debt instrument additional principal amount | $ 26,000,000 |
Debt instrument accrued interest rate | 3.375% |
Debt instrument frequency of periodic payment | semiannually |
Debt instrument minimum stock percentage of conversion price | 130.00% |