Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2015 | Aug. 04, 2015 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | FLXN | |
Entity Registrant Name | Flexion Therapeutics Inc | |
Entity Central Index Key | 1,419,600 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Non-accelerated Filer | |
Entity Common Stock, Shares Outstanding | 21,500,876 |
Consolidated Balance Sheets (Un
Consolidated Balance Sheets (Unaudited) - USD ($) | Jun. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 28,339,513 | $ 103,097,522 |
Marketable securities | 99,035,387 | 48,527,156 |
Accounts receivable | 199,593 | |
Prepaid expenses and other current assets | 1,220,589 | 502,314 |
Total current assets | 128,795,082 | 152,126,992 |
Property and equipment, net | 2,888,852 | 1,109,391 |
Other assets | 12,375 | |
Restricted cash | 104,000 | 128,000 |
Total assets | 131,787,934 | 153,376,758 |
Current liabilities: | ||
Accounts payable | 1,283,003 | 1,584,822 |
Accrued expenses and other current liabilities | 4,831,836 | 3,213,704 |
Current portion of long-term debt | 2,000,000 | |
Total current liabilities | 6,114,839 | 6,798,526 |
Long-term debt | 1,593,333 | |
Other long-term liabilities | 13,459 | 43,008 |
Total liabilities | $ 6,128,298 | $ 8,434,867 |
Commitments and contingencies | ||
Preferred Stock, $.001 par value; 10,000,000 shares authorized at June 30, 2015 and December 31, 2014 and 0 shares issued and outstanding at June 30, 2015 and December 31, 2014 | ||
Stockholders' equity: | ||
Common stock, $0.001 par value; 100,000,000 shares authorized; 21,500,876 and 21,440,058 shares issued and outstanding, at June 30, 2015 and December 31, 2014, respectively | $ 21,501 | $ 21,440 |
Additional paid-in capital | 240,731,524 | 238,402,514 |
Accumulated other comprehensive income | (6,449) | (5,240) |
Accumulated deficit | (115,086,940) | (93,476,823) |
Total stockholders' equity | 125,659,636 | 144,941,891 |
Total liabilities and stockholders' equity | $ 131,787,934 | $ 153,376,758 |
Consolidated Balance Sheets (U3
Consolidated Balance Sheets (Unaudited) (Parenthetical) - $ / shares | Jun. 30, 2015 | Dec. 31, 2014 |
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 | 21,500,876 | 21,440,058 |
Common stock, shares outstanding | 21,500,876 | 21,440,058 |
Consolidated Statements of Oper
Consolidated Statements of Operations and Comprehensive Loss (Unaudited) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Income Statement [Abstract] | ||||
Revenue | $ 0 | $ 0 | $ 0 | $ 0 |
Operating expenses: | ||||
Research and development | 9,640,017 | 3,614,593 | 15,895,128 | 7,765,440 |
General and administrative | 2,903,802 | 2,234,232 | 5,663,634 | 4,518,145 |
Total operating expenses | 12,543,819 | 5,848,825 | 21,558,762 | 12,283,585 |
Loss from operations | (12,543,819) | (5,848,825) | (21,558,762) | (12,283,585) |
Other income (expense): | ||||
Interest income | 439,959 | 134,644 | 608,322 | 165,402 |
Interest expense | (106,037) | (203,468) | (217,704) | |
Other income (expense), net | (332,734) | (110,384) | (456,209) | (136,959) |
Total other income (expense) | 107,225 | (81,777) | (51,355) | (189,261) |
Net loss | $ (12,436,594) | $ (5,930,602) | $ (21,610,117) | $ (12,472,846) |
Net loss per share basic and diluted | $ (0.58) | $ (0.38) | $ (1.01) | $ (1.07) |
Weighted average common shares outstanding, basic and diluted | 21,474,763 | 15,619,151 | 21,463,096 | 11,670,281 |
Other comprehensive (loss) income: | ||||
Unrealized gains from available-for-sale securities, net of tax of $0 | $ (21,644) | $ 2,380 | $ (1,209) | $ 3,250 |
Total other comprehensive (loss) income | (21,644) | 2,380 | (1,209) | 3,250 |
Comprehensive loss | $ (12,458,238) | $ (5,928,222) | $ (21,611,326) | $ (12,469,596) |
Consolidated Statements of Ope5
Consolidated Statements of Operations and Comprehensive Loss (Unaudited) (Parenthetical) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Income Statement [Abstract] | ||||
Other comprehensive (loss) income, Tax | $ 0 | $ 0 | $ 0 | $ 0 |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (Unaudited) - USD ($) | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
Cash flows from operating activities | ||
Net loss | $ (21,610,117) | $ (12,472,846) |
Adjustments to reconcile net loss to cash used in operating activities: | ||
Depreciation | 82,425 | 53,045 |
Stock-based compensation expense | 1,978,109 | 1,094,304 |
Amortization of premium (discount) on marketable securities | 434,849 | 99,549 |
Other non-cash charges | 12,375 | 8,250 |
Changes in operating assets and liabilities: | ||
Accounts receivable | (199,593) | |
Prepaid expenses, other current and long-term assets | (718,275) | (502,105) |
Accounts payable | (196,238) | 891 |
Accrued expenses and other current and long-term liabilities | 1,272,657 | (542,211) |
Other | (93,333) | |
Net cash used in operating activities | (19,037,141) | (12,261,123) |
Cash flows from investing activities | ||
Purchases of property and equipment | (1,426,892) | (61,613) |
Change in restricted cash | 24,000 | |
Purchases of marketable securities | (99,477,274) | (62,182,860) |
Sale and redemption of marketable securities | 48,532,984 | 2,360,000 |
Net cash used in investing activities | (52,347,182) | (59,884,473) |
Cash flows from financing activities | ||
Payment of public offering costs | (224,648) | (1,282,785) |
Payments on debt | (3,500,000) | (500,000) |
Proceeds from the issuance of common stock | 69,517,500 | |
Proceeds from the exercise of stock options | 213,428 | 237,997 |
Proceeds from Employee Stock Purchase Plan | 137,534 | |
Net cash (used in) provided by financing activities | (3,373,686) | 67,972,712 |
Net decrease in cash and cash equivalents | (74,758,009) | (4,172,884) |
Cash and cash equivalents at beginning of period | 103,097,522 | 16,188,254 |
Cash and cash equivalents at end of period | 28,339,513 | 12,015,370 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | 292,037 | 198,815 |
Supplemental disclosures of non-cash financing activities: | ||
Conversion of convertible preferred stock into common stock | $ 74,806,213 | |
Purchases of property and equipment in accounts payable and accrued | $ 487,005 |
Overview and Nature of the Busi
Overview and Nature of the Business | 6 Months Ended |
Jun. 30, 2015 | |
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, injectable pain therapies. The Company is targeting anti-inflammatory and analgesic therapies for the treatment of patients with musculoskeletal conditions, beginning with osteoarthritis, a type of degenerative arthritis (“OA”) and post-operative pain. Flexion’s broad and diversified portfolio of product candidates addresses the OA pain treatment spectrum, from moderate to severe pain, and provides the Company with multiple opportunities to achieve its goal of commercializing novel, patient-focused pain therapies. The Company is subject to risks and uncertainties common to 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 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 | 6 Months Ended |
Jun. 30, 2015 | |
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 June 30, 2015, and for the three and six months ended June 30, 2015 and 2014, 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 24, 2015. The information presented in the condensed consolidated financial statements and related notes as of June 30, 2015, and for the three and six months ended June 30, 2015 and 2014, is unaudited. The December 31, 2014 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 and six months ended June 30, 2015 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2015, or any future period. The accompanying 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 June 30, 2015 and December 31, 2014, the Company had cash and cash equivalents and marketable securities of $127,374,900 and $151,624,678, respectively. Management believes that current cash, cash equivalents and marketable securities on hand at June 30, 2015 should be sufficient to fund operations for at least the next twelve months. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations and to fund increased research and development costs in order to seek approval for commercialization of its product candidates. 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 the Company’s product candidates in order to generate future revenue streams. 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 and six months ended June 30, 2015 and the year ended December 31, 2014, the year Flexion Securities Corporation, Inc. was established. U.S. Government Grant The Company performs research and development for a U.S. Government agency under a cost reimbursable grant for clinical development of FX006. The related costs incurred under the grant are included in research and development expense in the statements of operations. The Company is reimbursed and offsets research and development expenses in the statement of operations when invoices for allowable costs are prepared and submitted to the U.S. Government agency. Payments under cost reimbursable grants with agencies of the U.S. Government are provisional payments subject to adjustment upon audit by the U.S. government. When the final determination of the allowable costs for any year has been made, research and development expenses may be adjusted accordingly. The grant also provides the U.S. government agency the ability to terminate the grant for various reasons, including if the Company fails to meet its obligations as set forth in the grant. Accounts Receivable Accounts receivable represents allowable costs under the Company’s U.S. Government agency grant for which the Company has not yet received reimbursement. The Company invoices the government on a quarterly basis for reimbursable costs under the grant. Reimbursable costs that have not been invoiced on the last day of the quarter are recorded as unbilled accounts receivable. 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 Computers, software and office equipment 3 Manufacturing equipment 7 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. Construction-in-progress, which represents direct costs related to the construction of manufacturing equipment, is not depreciated until the asset is completed and placed into service. |
Fair Value of Financial Assets
Fair Value of Financial Assets | 6 Months Ended |
Jun. 30, 2015 | |
Fair Value Disclosures [Abstract] | |
Fair Value of Financial Assets | 3. Fair Value of Financial Assets The following tables present information about the Company’s assets and liabilities that are measured at fair value on a recurring basis as of June 30, 2015 and December 31, 2014 and indicate the level of the fair value hierarchy utilized to determine such fair value: Fair Value Measurements as of June 30 , 2015 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ — $ 26,033,512 $ — $ 26,033,512 Marketable securities — 99,035,387 — 99,035,387 $ — $ 125,068,899 $ — $ 125,068,899 Fair Value Measurements as of December 31, 2014 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ — $ 101,687,995 $ — $ 101,687,995 Marketable securities — 48,527,156 — 48,527,156 $ — $ 150,215,151 $ — $ 150,215,151 As of June 30, 2015 and December 31, 2014, the Company’s cash equivalents and marketable securities that were invested primarily in U.S. treasury bills, corporate bonds, money market funds, commercial paper and U.S. Government agency holdings were valued based primarily on Level 2 inputs. The Company measures the fair value of marketable securities using Level 2 inputs and primarily relies on quoted prices in active markets for similar marketable securities. During the six months ended June 30, 2015 and year ended December 31, 2014, there were no transfers between Level 1, Level 2 and Level 3. The carrying values of accounts receivable, accounts payable and accrued expenses approximate their fair value due to the short-term nature of these balances. |
Marketable Securities
Marketable Securities | 6 Months Ended |
Jun. 30, 2015 | |
Investments, Debt and Equity Securities [Abstract] | |
Marketable Securities | 4. Marketable Securities As of June 30, 2015 and December 31, 2014, the fair value of available-for-sale marketable securities by type of security was as follows: June 30 , 2015 Amortized Cost Gross Unrealized Gross Unrealized Fair Value Commercial paper $ 23,732,634 $ 16,471 $ — $ 23,749,105 U.S. Government obligations 72,329,894 2,005 (25,100 ) 72,306,799 Corporate bonds 2,979,308 214 (39 ) 2,979,483 $ 99,041,836 $ 18,690 $ (25,139 ) $ 99,035,387 December 31, 2014 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Commercial paper $ 8,991,820 $ 7,570 $ — $ 8,999,390 U.S. Government obligations 28,300,921 181 (5,101 ) 28,296,001 Corporate bonds 11,239,655 2 (7,892 ) 11,231,765 $ 48,532,396 $ 7,753 $ (12,993 ) $ 48,527,156 At June 30, 2015 and December 31, 2014, marketable securities consisted of investments that mature within twelve months. |
Property and Equipment
Property and Equipment | 6 Months Ended |
Jun. 30, 2015 | |
Property, Plant and Equipment [Abstract] | |
Property and Equipment | 5. Property and Equipment Property and equipment as of June 30, 2015 and December 31, 2014 consisted of the following: June 30, December 31, Computer and office equipment $ 300,131 $ 229,980 Manufacturing equipment 153,140 153,140 Furniture and fixtures 181,366 181,366 Software 121,301 77,454 Leasehold improvements 134,573 134,573 Construction—in progress 2,349,205 601,317 3,239,716 1,377,830 Less: Accumulated depreciation (350,864 ) (268,439 ) Total property and equipment, net $ 2,888,852 $ 1,109,391 Depreciation expense for the six months ended June 30, 2015 and 2014, was $82,425 and $53,045, respectively. During the six months ended June 30, 2015 and 2014, there were no disposals of property and equipment. |
Accrued Expenses and Other Curr
Accrued Expenses and Other Current Liabilities | 6 Months Ended |
Jun. 30, 2015 | |
Payables and Accruals [Abstract] | |
Accrued Expenses and Other Current Liabilities | 6. Accrued Expenses and Other Current Liabilities Accrued expenses and other current liabilities consisted of the following: June 30, December 31, 2014 Clinical research $ 1,898,625 $ 1,035,510 Contract manufacturing services 1,315,305 294,900 Payroll and other employee-related expenses 1,081,125 1,172,978 Preclinical services 54,500 119,500 Consultant fees and expenses 135,000 26,900 Professional services fees 285,500 439,874 Interest expense — 24,111 Other 61,781 99,931 Total accrued expenses and other current liabilities $ 4,831,836 $ 3,213,704 |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | 7. Stock-Based Compensation Stock Option Valuation The fair value of each stock option grant is estimated on the date of grant using the Black-Scholes option-pricing model. Prior to the IPO, the Company was a private company and therefore lacked company-specific historical and implied volatility information. Therefore, it 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 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 six months ended June 30, 2015 and 2014 are as follows: Six months ended June 30, 2015 2014 Risk-free interest rates 1.49-1.92 % 1.54-1.99 % Expected dividend yield 0.00 % 0.00 % Expected term (in years) 6.0 6.0 Expected volatility 76.4-81.4 % 61.9-66.9 % The following table summarizes stock option activity for the six months ended June 30, 2015: Shares Weighted Outstanding as of December 31, 2014 1,289,082 $ 10.26 Granted 555,750 22.81 Exercised (49,851 ) 4.30 Canceled (71,886 ) 16.19 Outstanding as of June 30, 2015 1,723,095 $ 14.23 Options vested and expected to vest at June 30, 2015 1,470,834 Options exercisable at June 30, 2015 616,940 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 49,851 options were exercised during the six months ended June 30, 2015. The aggregate intrinsic value of stock options exercised during the six months ended June 30, 2015 was $850,611. At June 30, 2015 and 2014 the Company had options for the purchase of 1,723,095 and 1,201,740 shares of common stock outstanding, respectively, with a weighted average remaining contractual term of 8.3, and 8.5 years, respectively, and with a weighted average exercise price of $14.23 and $9.86 per share, respectively. The weighted average grant date fair value of options granted during the six months ended June 30, 2015 and 2014 was $15.67 and $10.31, respectively. Stock-based Compensation The Company recorded stock-based compensation expense related to stock options for the three and six months ended June 30, 2015 and 2014 as follows: Three months ended June 30, Six months ended June 30, 2015 2014 2015 2014 Research and development $ 287,398 $ 182,279 $ 609,147 $ 295,797 General and administrative 682,461 475,529 1,368,962 798,507 $ 969,859 $ 657,808 $ 1,978,109 $ 1,094,304 As of June 30, 2015, unrecognized stock-based compensation expense for stock options outstanding was $13,912,389, which is expected to be recognized over a weighted average period of 2.9 years. As of June 30, 2014, unrecognized stock-based compensation expense for stock options outstanding was $7,673,376, which was expected to be recognized over a weighted average period of 2.9 years. |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2015 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | 8. Net Loss Per Share Basic and diluted net loss per share attributable to common stockholders was calculated as follows for the three and six months ended June 30, 2015 and 2014: For the three months ended June 30, For the six months ended June 30, 2015 2014 2015 2014 Numerator: Net loss $ (12,436,594 ) $ (5,930,602 ) $ (21,610,117 ) $ (12,472,846 ) Net loss: $ (12,436,594 ) $ (5,930,602 ) $ (21,610,117 ) $ (12,472,846 ) Denominator: Weighted average common shares outstanding, basic and diluted 21,474,763 15,619,151 21,463,096 11,670,281 Net loss per share, basic and diluted $ (0.58 ) $ (0.38 ) $ (1.01 ) $ (1.07 ) Stock options for the purchase of 1,669,833 and 1,208,919 weighted average shares of common stock were excluded from the computation of diluted net loss per share attributable to common stockholders for the three months ended June 30, 2015 and 2014, respectively, and 1,628,669 and 1,076,923 weighted average shares of common stock were excluded from the computation of diluted net loss per share attributable to common stockholders for the six months ended June 30, 2015 and 2014, respectively. These options were excluded from the computations because the options had an anti-dilutive impact due to the net loss incurred for those periods. |
Long-term Debt
Long-term Debt | 6 Months Ended |
Jun. 30, 2015 | |
Debt Disclosure [Abstract] | |
Long-term Debt | 9. Long-term Debt On January 3, 2013, the Company entered into a credit and security agreement with MidCap Financial SBIC, LP (“MidCap”) under which it immediately borrowed $5,000,000 as a term loan. The term loan accrued interest monthly at an interest rate of 8.0% per annum and had a term of 45 months. As the term loan had a 15-month interest-only period, the term loan principal balance, along with any accrued interest, was to be paid in 30 equal monthly installments beginning April 1, 2014 and ending September 1, 2016. In addition to these principal payments, the Company was required to make a payment of $175,000 to the lender on September 1, 2016, which amount was accreted to the carrying value of the debt using the effective interest rate method. On March 31, 2015, the Company paid MidCap $3,236,019, representing the outstanding principal of the debt along with accrued interest as of that date, the $175,000 final payment, a prepayment fee of $30,000 and associated legal expenses to satisfy the Company’s obligation under the credit and security agreement. Prior to the debt repayment, the term loan outstanding under the Company’s credit and security agreement with MidCap was reported at its carrying value in the accompanying balance sheet. The Company determined the fair value of the term loan using an income approach, utilizing 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 term loan was valued using Level 2 inputs as of December 31, 2014. The result of the calculation yielded a fair value that approximated carrying value. |
Subsequent Events
Subsequent Events | 6 Months Ended |
Jun. 30, 2015 | |
Subsequent Events [Abstract] | |
Subsequent Events | 10. Subsequent Events Lease Amendment On July 13, 2015 the Company entered into a first amendment to its existing lease for approximately 4,700 square feet of additional office space (the “Additional Space”) in Burlington Massachusetts as well as approximately 6,700 square feet of temporary space to be leased prior to the delivery of the Additional Space (which is anticipated to be delivered on May 1, 2016). The amendment extends the term of the original lease through October 31, 2019, contiguous with the Additional Space, and also provides the Company with an option to lease an additional 5,400 square feet of office space (the “Option Space”). In addition, the Company has the option to extend the term of a portion or the entire lease space for one additional three-year period. The Company may also terminate the amendment for convenience with nine months’ notice upon the occurrence of certain events connected to its clinical stage programs. The total cash obligation for the base rent through the lease termination date for the office space committed to under the original lease, and the amendment is approximately $2,500,000 and, if the Company elects to exercise its rights to the further expand into the Option Space, it would owe an additional $601,000 through the lease termination date. In addition to the base rent, the Company is also responsible for its share of operating expenses and real estate taxes. Manufacturing and Supply Agreement with Patheon U.K. Limited On July 31, 2015, the Company and Patheon U.K. Limited (“Patheon”) entered into a Manufacturing and Supply Agreement (the “Manufacturing Agreement”) and Technical Transfer and Service Agreement (the “Technical Transfer Agreement”) for the manufacture of FX006, the Company’s lead program, which is an intra-articular (IA) sustained-release steroid for the treatment of osteoarthritis. Patheon has agreed in the Technical Transfer Agreement to undertake certain technical transfer activities and construction services needed to prepare Patheon’s Swindon, United Kingdom facility for the commercial manufacture of FX006 in dedicated manufacturing suites. The Company will provide Patheon with certain equipment and materials necessary to manufacture FX006 and it will pay Patheon a monthly fee for such activities and reimburse Patheon for certain material, equipment and miscellaneous expenses and additional services. The initial term of the Manufacturing Agreement is 10 years from FDA approval of the Patheon manufacturing suites for FX006. The Company will pay a monthly base fee to Patheon for the operation of the manufacturing suites and a per product fee for each vial of FX006 produced by Patheon. The Company will also reimburse Patheon for purchases of materials and equipment made on its behalf, certain nominal expenses and additional services. The Company will file copies of the Agreements as exhibits to our Quarterly Report on Form 10-Q for the quarter ending September 30, 2015. Long-term Debt On August 4, 2015, the Company entered into a credit and security agreement with MidCap Financial Trust, as agent, MidCap Financial Funding XIII Trust and Silicon Valley Bank, as agent, (the “Lenders”), to borrow up to $30 million in term loans. The Company concurrently borrowed $15.0 million under an intial term loan. The remaining $15.0 million under the facility may be drawn down in the form of a second term loan at the Company’s option through September 2016, subject to the Company’s receipt of positive Phase 3 data meeting primary endpoints which is sufficient to file and NDA for FX006, as well as other customary conditions for funding. Borrowings under the credit facility accrue interest monthly at a fixed interest rate of 6.25 % per annum. Following an interest-only period, 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 Company may elect to prepay all amounts under the facility prior to the maturity date, subject to a prepayment fee equal to 3% of the amount prepaid if the prepayment occurs prior to the first anniversary of the closing date, 2% if the prepayment occurs on or after the first anniversary and prior to the second anniversary of the closing date, 1% if the prepayment occurs on or after the second anniversary and prior the third anniversary of the closing date, and 0% thereafter. 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 also agreed not to encumber any of its intellectual property without the Lenders’ prior written consent. |
Summary of Significant Accoun17
Summary of Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2015 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation The accompanying condensed consolidated financial statements as of June 30, 2015, and for the three and six months ended June 30, 2015 and 2014, 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 24, 2015. The information presented in the condensed consolidated financial statements and related notes as of June 30, 2015, and for the three and six months ended June 30, 2015 and 2014, is unaudited. The December 31, 2014 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 and six months ended June 30, 2015 are not necessarily indicative of the results that may be expected for the fiscal year ending December 31, 2015, or any future period. The accompanying 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 June 30, 2015 and December 31, 2014, the Company had cash and cash equivalents and marketable securities of $127,374,900 and $151,624,678, respectively. Management believes that current cash, cash equivalents and marketable securities on hand at June 30, 2015 should be sufficient to fund operations for at least the next twelve months. The future viability of the Company is dependent on its ability to raise additional capital to finance its operations and to fund increased research and development costs in order to seek approval for commercialization of its product candidates. 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 the Company’s product candidates in order to generate future revenue streams. |
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 and six months ended June 30, 2015 and the year ended December 31, 2014, the year Flexion Securities Corporation, Inc. was established. |
U.S. Government Grant | U.S. Government Grant The Company performs research and development for a U.S. Government agency under a cost reimbursable grant for clinical development of FX006. The related costs incurred under the grant are included in research and development expense in the statements of operations. The Company is reimbursed and offsets research and development expenses in the statement of operations when invoices for allowable costs are prepared and submitted to the U.S. Government agency. Payments under cost reimbursable grants with agencies of the U.S. Government are provisional payments subject to adjustment upon audit by the U.S. government. When the final determination of the allowable costs for any year has been made, research and development expenses may be adjusted accordingly. The grant also provides the U.S. government agency the ability to terminate the grant for various reasons, including if the Company fails to meet its obligations as set forth in the grant. |
Accounts Receivable | Accounts Receivable Accounts receivable represents allowable costs under the Company’s U.S. Government agency grant for which the Company has not yet received reimbursement. The Company invoices the government on a quarterly basis for reimbursable costs under the grant. Reimbursable costs that have not been invoiced on the last day of the quarter are recorded as unbilled accounts receivable. |
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. |
Summary of Significant Accoun18
Summary of Significant Accounting Policies (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Accounting Policies [Abstract] | |
Property Plant and Equipment Estimated Useful Lives | 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 Computers, software and office equipment 3 Manufacturing equipment 7 Furniture and fixtures 5 |
Fair Value of Financial Assets
Fair Value of Financial Assets (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Fair Value Disclosures [Abstract] | |
Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis | The following tables present information about the Company’s assets and liabilities that are measured at fair value on a recurring basis as of June 30, 2015 and December 31, 2014 and indicate the level of the fair value hierarchy utilized to determine such fair value: Fair Value Measurements as of June 30 , 2015 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ — $ 26,033,512 $ — $ 26,033,512 Marketable securities — 99,035,387 — 99,035,387 $ — $ 125,068,899 $ — $ 125,068,899 Fair Value Measurements as of December 31, 2014 Using: Level 1 Level 2 Level 3 Total Assets: Cash equivalents $ — $ 101,687,995 $ — $ 101,687,995 Marketable securities — 48,527,156 — 48,527,156 $ — $ 150,215,151 $ — $ 150,215,151 |
Marketable Securities (Tables)
Marketable Securities (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Investments, Debt and Equity Securities [Abstract] | |
Summary of Fair Value of Available-for-Sale Marketable Securities by Type of Security | As of June 30, 2015 and December 31, 2014, the fair value of available-for-sale marketable securities by type of security was as follows: June 30 , 2015 Amortized Cost Gross Unrealized Gross Unrealized Fair Value Commercial paper $ 23,732,634 $ 16,471 $ — $ 23,749,105 U.S. Government obligations 72,329,894 2,005 (25,100 ) 72,306,799 Corporate bonds 2,979,308 214 (39 ) 2,979,483 $ 99,041,836 $ 18,690 $ (25,139 ) $ 99,035,387 December 31, 2014 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Fair Value Commercial paper $ 8,991,820 $ 7,570 $ — $ 8,999,390 U.S. Government obligations 28,300,921 181 (5,101 ) 28,296,001 Corporate bonds 11,239,655 2 (7,892 ) 11,231,765 $ 48,532,396 $ 7,753 $ (12,993 ) $ 48,527,156 |
Property and Equipment (Tables)
Property and Equipment (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Property, Plant and Equipment [Abstract] | |
Components of Property and Equipment | Property and equipment as of June 30, 2015 and December 31, 2014 consisted of the following: June 30, December 31, Computer and office equipment $ 300,131 $ 229,980 Manufacturing equipment 153,140 153,140 Furniture and fixtures 181,366 181,366 Software 121,301 77,454 Leasehold improvements 134,573 134,573 Construction—in progress 2,349,205 601,317 3,239,716 1,377,830 Less: Accumulated depreciation (350,864 ) (268,439 ) Total property and equipment, net $ 2,888,852 $ 1,109,391 |
Accrued Expenses and Other Cu22
Accrued Expenses and Other Current Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses and Other Current Liabilities | Accrued expenses and other current liabilities consisted of the following: June 30, December 31, 2014 Clinical research $ 1,898,625 $ 1,035,510 Contract manufacturing services 1,315,305 294,900 Payroll and other employee-related expenses 1,081,125 1,172,978 Preclinical services 54,500 119,500 Consultant fees and expenses 135,000 26,900 Professional services fees 285,500 439,874 Interest expense — 24,111 Other 61,781 99,931 Total accrued expenses and other current liabilities $ 4,831,836 $ 3,213,704 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based 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 six months ended June 30, 2015 and 2014 are as follows: Six months ended June 30, 2015 2014 Risk-free interest rates 1.49-1.92 % 1.54-1.99 % Expected dividend yield 0.00 % 0.00 % Expected term (in years) 6.0 6.0 Expected volatility 76.4-81.4 % 61.9-66.9 % |
Summary of Stock Option Activity | The following table summarizes stock option activity for the six months ended June 30, 2015: Shares Weighted Outstanding as of December 31, 2014 1,289,082 $ 10.26 Granted 555,750 22.81 Exercised (49,851 ) 4.30 Canceled (71,886 ) 16.19 Outstanding as of June 30, 2015 1,723,095 $ 14.23 Options vested and expected to vest at June 30, 2015 1,470,834 Options exercisable at June 30, 2015 616,940 |
Stock-Based Compensation Expense Related to Stock Options | The Company recorded stock-based compensation expense related to stock options for the three and six months ended June 30, 2015 and 2014 as follows: Three months ended June 30, Six months ended June 30, 2015 2014 2015 2014 Research and development $ 287,398 $ 182,279 $ 609,147 $ 295,797 General and administrative 682,461 475,529 1,368,962 798,507 $ 969,859 $ 657,808 $ 1,978,109 $ 1,094,304 |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Earnings Per Share [Abstract] | |
Schedule of Basic and Diluted Net Loss per Share Attributable to Common Stockholders | Basic and diluted net loss per share attributable to common stockholders was calculated as follows for the three and six months ended June 30, 2015 and 2014: For the three months ended June 30, For the six months ended June 30, 2015 2014 2015 2014 Numerator: Net loss $ (12,436,594 ) $ (5,930,602 ) $ (21,610,117 ) $ (12,472,846 ) Net loss: $ (12,436,594 ) $ (5,930,602 ) $ (21,610,117 ) $ (12,472,846 ) Denominator: Weighted average common shares outstanding, basic and diluted 21,474,763 15,619,151 21,463,096 11,670,281 Net loss per share, basic and diluted $ (0.58 ) $ (0.38 ) $ (1.01 ) $ (1.07 ) |
Overview and Nature of the Bu25
Overview and Nature of the Business - Additional Information (Detail) | 6 Months Ended |
Jun. 30, 2015 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
Incorporation date | Nov. 5, 2007 |
Summary of Significant Accoun26
Summary of Significant Accounting Policies - Additional Information (Detail) - USD ($) | Jun. 30, 2015 | Dec. 31, 2014 |
Accounting Policies [Abstract] | ||
Cash and cash equivalents and marketable securities | $ 127,374,900 | $ 151,624,678 |
Summary of Significant Accoun27
Summary of Significant Accounting Policies - Property Plant and Equipment Estimated Useful Lives (Detail) | 6 Months Ended |
Jun. 30, 2015 | |
Computers, Software and Office Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Estimated Useful Lives | 3 years |
Manufacturing Equipment [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Estimated Useful Lives | 7 years |
Furniture and Fixtures [Member] | |
Property, Plant and Equipment [Line Items] | |
Property, Plant and Equipment, Estimated Useful Lives | 5 years |
Fair Value of Financial Asset28
Fair Value of Financial Assets - Schedule of Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - USD ($) | Jun. 30, 2015 | Dec. 31, 2014 |
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Marketable securities | $ 99,035,387 | $ 48,527,156 |
Fair Value Measurements, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 26,033,512 | 101,687,995 |
Marketable securities | 99,035,387 | 48,527,156 |
Assets, Total | 125,068,899 | 150,215,151 |
Level 2 [Member] | Fair Value Measurements, Recurring [Member] | ||
Fair Value, Assets and Liabilities Measured on Recurring and Nonrecurring Basis [Line Items] | ||
Cash equivalents | 26,033,512 | 101,687,995 |
Marketable securities | 99,035,387 | 48,527,156 |
Assets, Total | $ 125,068,899 | $ 150,215,151 |
Fair Value of Financial Asset29
Fair Value of Financial Assets - Additional Information (Detail) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2015 | Dec. 31, 2014 | |
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 ($) | Jun. 30, 2015 | Dec. 31, 2014 |
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | $ 99,041,836 | $ 48,532,396 |
Gross Unrealized Gains | 18,690 | 7,753 |
Gross Unrealized Losses | (25,139) | (12,993) |
Fair Value | 99,035,387 | 48,527,156 |
Commercial Paper [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 23,732,634 | 8,991,820 |
Gross Unrealized Gains | 16,471 | 7,570 |
Fair Value | 23,749,105 | 8,999,390 |
U.S Government Obligations [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 72,329,894 | 28,300,921 |
Gross Unrealized Gains | 2,005 | 181 |
Gross Unrealized Losses | (25,100) | (5,101) |
Fair Value | 72,306,799 | 28,296,001 |
Corporate Bonds [Member] | ||
Schedule of Available-for-sale Securities [Line Items] | ||
Amortized Cost | 2,979,308 | 11,239,655 |
Gross Unrealized Gains | 214 | 2 |
Gross Unrealized Losses | (39) | (7,892) |
Fair Value | $ 2,979,483 | $ 11,231,765 |
Property and Equipment - Compon
Property and Equipment - Components of Property and Equipment (Detail) - USD ($) | Jun. 30, 2015 | Dec. 31, 2014 |
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | $ 3,239,716 | $ 1,377,830 |
Less: Accumulated depreciation | (350,864) | (268,439) |
Total property and equipment, net | 2,888,852 | 1,109,391 |
Computer and Office Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | 300,131 | 229,980 |
Manufacturing Equipment [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | 153,140 | 153,140 |
Furniture and Fixtures [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | 181,366 | 181,366 |
Leasehold Improvements [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | 134,573 | 134,573 |
Construction-in Progress [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | 2,349,205 | 601,317 |
Software [Member] | ||
Property, Plant and Equipment [Line Items] | ||
Property and equipment gross | $ 121,301 | $ 77,454 |
Property and Equipment - Additi
Property and Equipment - Additional Information (Detail) - USD ($) | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
Property, Plant and Equipment [Abstract] | ||
Depreciation | $ 82,425 | $ 53,045 |
Property and equipment disposals | $ 0 | $ 0 |
Accrued Expenses and Other Cu33
Accrued Expenses and Other Current Liabilities - Schedule of Accrued Expenses and Other Current Liabilities (Detail) - USD ($) | Jun. 30, 2015 | Dec. 31, 2014 |
Payables and Accruals [Abstract] | ||
Clinical research | $ 1,898,625 | $ 1,035,510 |
Contract manufacturing services | 1,315,305 | 294,900 |
Payroll and other employee-related expenses | 1,081,125 | 1,172,978 |
Preclinical services | 54,500 | 119,500 |
Consultant fees and expenses | 135,000 | 26,900 |
Professional services fees | 285,500 | 439,874 |
Interest expense | 24,111 | |
Other | 61,781 | 99,931 |
Total accrued expenses and other current liabilities | $ 4,831,836 | $ 3,213,704 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Relevant Data Used to Estimate Fair Value of Stock Option Grants (Detail) | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||
Risk-free interest rates, Minimum | 1.49% | 1.54% |
Risk-free interest rates, Maximum | 1.92% | 1.99% |
Expected dividend yield | 0.00% | 0.00% |
Expected term (in years) | 6 years | 6 years |
Expected volatility, Minimum | 76.40% | 61.90% |
Expected volatility, Maximum | 81.40% | 66.90% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Detail) - Jun. 30, 2015 - $ / shares | Total |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Shares Issuable Under Options, Beginning balance | 1,289,082 |
Shares Issuable Under Options, Granted | 555,750 |
Shares Issuable Under Options, Exercised | (49,851) |
Shares Issuable Under Options, Canceled | (71,886) |
Shares Issuable Under Options, Ending balance | 1,723,095 |
Shares Issuable Under Options, Options vested and expected to vest at June 30, 2015 | 1,470,834 |
Shares Issuable Under Options, Options exercisable at June 30, 2015 | 616,940 |
Weighted Average Exercise Price, Beginning balance | $ 10.26 |
Weighted Average Exercise Price, Granted | 22.81 |
Weighted Average Exercise Price, Exercised | 4.30 |
Weighted Average Exercise Price, Canceled | 16.19 |
Weighted Average Exercise Price, Ending balance | $ 14.23 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Detail) - USD ($) | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Dec. 31, 2014 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |||
Number of options exercised | 49,851 | ||
Aggregate intrinsic value of stock options exercised | $ 850,611 | ||
Options to purchase common stock, outstanding | 1,723,095 | 1,201,740 | 1,289,082 |
Weighted average remaining contractual term | 8 years 3 months 18 days | 8 years 6 months | |
Weighted average exercise price | $ 14.23 | $ 9.86 | $ 10.26 |
Weighted average grant date fair value of options granted | $ 15.67 | $ 10.31 | |
Unrecognized stock-based compensation expense | $ 13,912,389 | $ 7,673,376 | |
Unrecognized compensation costs, weighted-average recognition periods | 2 years 10 months 24 days | 2 years 10 months 24 days |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation Expense Related to Stock Options (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 969,859 | $ 657,808 | $ 1,978,109 | $ 1,094,304 |
Research and Development [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | 287,398 | 182,279 | 609,147 | 295,797 |
General and Administrative [Member] | ||||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Stock-based compensation expense | $ 682,461 | $ 475,529 | $ 1,368,962 | $ 798,507 |
Net Loss Per Share - Schedule o
Net Loss Per Share - Schedule of Basic and Diluted Net Loss per Share Attributable to Common Stockholders (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Numerator: | ||||
Net loss | $ (12,436,594) | $ (5,930,602) | $ (21,610,117) | $ (12,472,846) |
Net loss: | $ (12,436,594) | $ (5,930,602) | $ (21,610,117) | $ (12,472,846) |
Denominator: | ||||
Weighted average common shares outstanding, basic and diluted | 21,474,763 | 15,619,151 | 21,463,096 | 11,670,281 |
Net loss per share, basic and diluted | $ (0.58) | $ (0.38) | $ (1.01) | $ (1.07) |
Net Loss Per Share - Additional
Net Loss Per Share - Additional Information (Detail) - shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Stock Options [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 stockholders | 1,669,833 | 1,208,919 | 1,628,669 | 1,076,923 |
Long-Term Debt - Additional Inf
Long-Term Debt - Additional Information (Detail) - Mid Cap [Member] - Secured Debt [Member] - USD ($) | 3 Months Ended | 6 Months Ended | |
Mar. 31, 2015 | Jun. 30, 2015 | Jan. 03, 2013 | |
Debt Instrument [Line Items] | |||
Term loan, borrowings | $ 5,000,000 | ||
Debt instrument interest rate | 8.00% | ||
Term loan, Interest payment period | 45 months | ||
Term loan, payment description | 15-month interest-only period, the term loan principal balance, along with any accrued interest, was to be paid in 30 equal monthly installments | ||
Term loan, first periodic payment date | Apr. 1, 2014 | ||
Term loan, last periodic payment date | Sep. 1, 2016 | ||
Final principal payments made to lender | $ 175,000 | ||
Debt instrument principal payment | 3,236,019 | ||
Debt instrument prepayment fee | $ 30,000 | ||
Interest-Only-Strip [Member] | |||
Debt Instrument [Line Items] | |||
Term loan, Interest payment period | 15 months | ||
Principal-Only-Strip [Member] | |||
Debt Instrument [Line Items] | |||
Term loan, Interest payment period | 30 months |
Subsequent Events - Additional
Subsequent Events - Additional Information (Detail) - Subsequent Event [Member] | Aug. 04, 2015USD ($) | Jul. 13, 2015USD ($)ft² | Jul. 31, 2015 |
Patheon [Member] | |||
Subsequent Event [Line Items] | |||
Manufacturing agreement period | 10 years | ||
Secured Debt [Member] | Mid Cap Financial Trust [Member] | |||
Subsequent Event [Line Items] | |||
Term loan, maximum borrowings | $ 30,000,000 | ||
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% | ||
Interest rate of prepayment occurs prior to the first anniversary | 3.00% | ||
Interest rate of prepayment occurs on or after the first anniversary and prior to second the anniversary interest rate | 2.00% | ||
Interest rate of prepayment occurs on or after the second anniversary and prior the third anniversary interest rate | 1.00% | ||
Interest rate of prepayment occurs thereafter interest rate | 0.00% | ||
Term loan, payment description | Interest-only period, principal will be due in 36 equal monthly installments | ||
Secured Debt [Member] | Mid Cap Financial Trust [Member] | Principal-Only-Strip [Member] | |||
Subsequent Event [Line Items] | |||
Term loan, maturity period | 36 months | ||
Initial Term Loan [Member] | Secured Debt [Member] | Mid Cap Financial Trust [Member] | |||
Subsequent Event [Line Items] | |||
Term loan, currently borrowed | $ 15,000,000 | ||
Second Term Loan [Member] | Secured Debt [Member] | Mid Cap Financial Trust [Member] | |||
Subsequent Event [Line Items] | |||
Term loan, remaining borrowing | $ 15,000,000 | ||
Burlington Massachusetts [Member] | |||
Subsequent Event [Line Items] | |||
Additional leased office space | ft² | 4,700 | ||
Office space leased on temporary agreement | ft² | 6,700 | ||
Anticipated lease commencement date of extended office space | May 1, 2016 | ||
Lease termination date | Oct. 31, 2019 | ||
Extended leased office space | ft² | 5,400 | ||
Extended lease agreement period | 3 years | ||
Operating lease early termination notice period | 9 months | ||
Base rent for original, amended office space | $ 2,500,000 | ||
Additional base rent for office space leased on option | $ 601,000 |