Document and Entity Information
Document and Entity Information - shares | 9 Months Ended | |
Sep. 30, 2017 | Oct. 31, 2017 | |
Document and Entity Information | ||
Entity Registrant Name | INSMED INC | |
Entity Central Index Key | 1,104,506 | |
Document Type | 10-Q | |
Document Period End Date | Sep. 30, 2017 | |
Amendment Flag | false | |
Current Fiscal Year End Date | --12-31 | |
Entity Current Reporting Status | Yes | |
Entity Filer Category | Large Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 76,591,009 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q3 |
Consolidated Balance Sheets (un
Consolidated Balance Sheets (unaudited) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 430,678 | $ 162,591 |
Prepaid expenses and other current assets | 6,802 | 5,816 |
Total current assets | 437,480 | 168,407 |
In-process research and development | 58,200 | 58,200 |
Fixed assets, net | 8,975 | 10,020 |
Other assets | 1,551 | 1,329 |
Total assets | 506,206 | 237,956 |
Current liabilities: | ||
Accounts payable | 9,348 | 10,439 |
Accrued expenses | 18,802 | 16,822 |
Other current liabilities | 616 | 728 |
Total current liabilities | 28,766 | 27,989 |
Debt, long-term | 55,388 | 54,791 |
Other long-term liabilities | 747 | 693 |
Total liabilities | 84,901 | 83,473 |
Shareholders’ equity: | ||
Common stock, $0.01 par value; 500,000,000 authorized shares, 76,568,368 and 62,019,889 issued and outstanding shares at September 30, 2017 and December 31, 2016, respectively | 766 | 620 |
Additional paid-in capital | 1,313,006 | 919,164 |
Accumulated deficit | (892,501) | (765,236) |
Accumulated other comprehensive income (loss) | 34 | (65) |
Total shareholders’ equity | 421,305 | 154,483 |
Total liabilities and shareholders’ equity | $ 506,206 | $ 237,956 |
Consolidated Balance Sheets (u3
Consolidated Balance Sheets (unaudited) (Parenthetical) - $ / shares | Sep. 30, 2017 | Dec. 31, 2016 |
Statement of Financial Position [Abstract] | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 |
Common stock, authorized shares (in shares) | 500,000,000 | 500,000,000 |
Common stock, issued shares (in shares) | 76,568,368 | 62,019,889 |
Common stock, outstanding shares (in shares) | 76,568,368 | 62,019,889 |
Consolidated Statements of Comp
Consolidated Statements of Comprehensive Loss (unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Statement of Comprehensive Income [Abstract] | ||||
Revenues | $ 0 | $ 0 | $ 0 | $ 0 |
Operating expenses: | ||||
Research and development | 26,675 | 23,433 | 75,800 | 67,851 |
General and administrative | 17,408 | 13,716 | 47,767 | 38,498 |
Total operating expenses | 44,083 | 37,149 | 123,567 | 106,349 |
Operating loss | (44,083) | (37,149) | (123,567) | (106,349) |
Investment income | 326 | 138 | 649 | 472 |
Interest expense | (1,496) | (769) | (4,459) | (2,015) |
Other income, net | 101 | 45 | 206 | 92 |
Loss before income taxes | (45,152) | (37,735) | (127,171) | (107,800) |
Provision for income taxes | 27 | 25 | 94 | 71 |
Net loss | $ (45,179) | $ (37,760) | $ (127,265) | $ (107,871) |
Basic and diluted net loss per share | $ (0.69) | $ (0.61) | $ (2.01) | $ (1.74) |
Weighted average basic and diluted common shares outstanding | 65,312 | 61,878 | 63,199 | 61,871 |
Net loss | $ (45,179) | $ (37,760) | $ (127,265) | $ (107,871) |
Other comprehensive income (loss): | ||||
Foreign currency translation gains (losses) | 76 | (17) | 99 | (5) |
Total comprehensive loss | $ (45,103) | $ (37,777) | $ (127,166) | $ (107,876) |
Consolidated Statements of Cash
Consolidated Statements of Cash Flows (unaudited) - USD ($) $ in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Operating activities | ||
Net loss | $ (127,265) | $ (107,871) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation | 2,168 | 1,756 |
Stock-based compensation expense | 13,332 | 13,879 |
Amortization of debt issuance costs | 91 | 250 |
Accretion of back-end fee on debt | 506 | 0 |
Changes in operating assets and liabilities: | ||
Prepaid expenses and other assets | (1,052) | (230) |
Accounts payable | (921) | 361 |
Accrued expenses and other | 1,745 | 3,109 |
Net cash used in operating activities | (111,396) | (88,746) |
Investing activities | ||
Purchase of fixed assets | (1,301) | (3,428) |
Net cash used in investing activities | (1,301) | (3,428) |
Financing activities | ||
Proceeds from exercise of stock options | 2,953 | 128 |
Proceeds from issuance of debt | 0 | 10,000 |
Payment of debt issuance costs | 0 | (308) |
Proceeds from issuance of common stock, net | 377,703 | 0 |
Net cash provided by financing activities | 380,656 | 9,820 |
Effect of exchange rates on cash and cash equivalents | 128 | (4) |
Net increase (decrease) in cash and cash equivalents | 268,087 | (82,358) |
Cash and cash equivalents at beginning of period | 162,591 | 282,876 |
Cash and cash equivalents at end of period | 430,678 | 200,518 |
Supplemental disclosures of cash flow information: | ||
Cash paid for interest | 3,876 | 2,471 |
Cash paid for income taxes | $ 62 | $ 49 |
The Company and Basis of Presen
The Company and Basis of Presentation | 9 Months Ended |
Sep. 30, 2017 | |
Organization, Consolidation and Presentation of Financial Statements [Abstract] | |
The Company and Basis of Presentation | The Company and Basis of Presentation Insmed is a global biopharmaceutical company focused on the unmet needs of patients with rare diseases. The Company's lead product candidate is amikacin liposome inhalation suspension (ALIS) (formerly known as liposomal amikacin for inhalation, or LAI), which is in late‑stage development for adult patients with treatment refractory nontuberculous mycobacteria (NTM) lung disease caused by Mycobacterium avium complex (MAC), a rare and often chronic infection that can cause irreversible lung damage and which can be fatal. The Company's earlier clinical-stage pipeline includes INS1007 and INS1009. INS1007 is a novel oral, reversible inhibitor of dipeptidyl peptidase 1 (DPP1), an enzyme responsible for activating neutrophil serine proteases, which are implicated in the pathology of chronic inflammatory lung diseases, such as non-cystic fibrosis (non-CF) bronchiectasis. INS1009 is an inhaled nanoparticle formulation of a treprostinil prodrug that may offer a differentiated product profile for rare pulmonary disorders, including pulmonary arterial hypertension (PAH). The Company was incorporated in the Commonwealth of Virginia on November 29, 1999 and its principal executive offices are in Bridgewater, New Jersey. The Company has legal entities in the United States (US), Ireland, Germany, France, the United Kingdom (UK) and the Netherlands. All intercompany transactions and balances have been eliminated in consolidation. The accompanying unaudited interim consolidated financial statements have been prepared pursuant to the rules and regulations for reporting on Form 10-Q. Accordingly, certain information and disclosures required by accounting principles generally accepted in the US for complete consolidated financial statements are not included herein. The unaudited interim consolidated financial statements should be read in conjunction with the audited consolidated financial statements and notes thereto included in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016 . The results of operations of any interim period are not necessarily indicative of the results of operations for the full year. The unaudited interim consolidated financial information presented herein reflects all normal adjustments that are, in the opinion of management, necessary for a fair statement of the financial position, results of operations and cash flows for the periods presented. |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | Summary of Significant Accounting Policies The following are interim updates to certain of the policies described in “Note 2” to the Company’s audited consolidated financial statements in the Company’s Annual Report on Form 10-K for the year ended December 31, 2016 : Fair Value Measurements - The Company categorizes its financial assets and liabilities measured and reported at fair value in the financial statements on a recurring basis based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels, which are directly related to the amount of subjectivity associated with the inputs used to determine the fair value of financial assets and liabilities, are as follows: • Level 1 — Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. • Level 2 — Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the assets or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life. • Level 3 — Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. Each major category of financial assets and liabilities measured at fair value on a recurring basis are categorized based upon the lowest level of significant input to the valuations. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Financial instruments in Level 1 generally include US treasuries and mutual funds listed in active markets. The Company’s only financial assets and liabilities which were measured at fair value as of September 30, 2017 and December 31, 2016 were Level 1 and such assets were comprised of cash and cash equivalents of $430.7 million and $162.6 million , respectively. The Company’s cash and cash equivalents permit daily redemption and the fair values of these investments are based upon the quoted prices in active markets provided by the holding financial institutions. Cash equivalents consist of liquid investments with a maturity of three months or less from the date of purchase. The Company recognizes transfers between levels within the fair value hierarchy, if any, at the end of each quarter. There were no transfers in or out of Level 1, Level 2 or Level 3 during the three and nine months ended September 30, 2017 and 2016 , respectively. As of September 30, 2017 and December 31, 2016 , the Company held no securities that were in an unrealized gain or loss position. The Company reviews the status of each security quarterly to determine whether an other-than-temporary impairment has occurred. In making its determination, the Company considers a number of factors, including: (1) the significance of the decline; (2) whether the securities were rated below investment grade; (3) how long the securities have been in an unrealized loss position; and (4) the Company’s ability and intent to retain the investment for a sufficient period of time for it to recover. Net Loss Per Share - Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted average number of common shares and other dilutive securities outstanding during the period. Potentially dilutive securities from stock options and restricted stock units (RSUs) would be anti-dilutive as the Company incurred a net loss. Potentially dilutive common shares resulting from the assumed exercise of outstanding stock options are determined based on the treasury stock method. The following table sets forth the reconciliation of the weighted average number of common shares used to compute basic and diluted net loss per share for the three and nine months ended September 30, 2017 and 2016 : Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (in thousands, except per share amounts) Numerator: Net loss $ (45,179 ) $ (37,760 ) $ (127,265 ) $ (107,871 ) Denominator: Weighted average common shares used in calculation of basic net loss per share: 65,312 61,878 63,199 61,871 Effect of dilutive securities: Common stock options — — — — RSUs — — — — Weighted average common shares outstanding used in calculation of diluted net loss per share 65,312 61,878 63,199 61,871 Net loss per share: Basic and Diluted $ (0.69 ) $ (0.61 ) $ (2.01 ) $ (1.74 ) The following potentially dilutive securities have been excluded from the computations of diluted weighted average common shares outstanding as of September 30, 2017 and 2016 as their effect would have been anti-dilutive (in thousands): 2017 2016 Stock options to purchase common stock 8,601 7,306 Unvested RSUs 47 89 Recently Adopted Accounting Pronouncements - In August 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , which defines management’s responsibility to perform interim and annual assessments of an entity’s ability to continue as a going concern, and to provide related footnote disclosures if there is substantial doubt about its ability to continue as a going concern. The new standard was effective for the annual period ending after December 15, 2016, and for interim periods thereafter. The Company adopted ASU 2014-15 in the fourth quarter of 2016 , which had no impact on the Company’s consolidated financial statements. The interim assessment during the first three quarters of 2017 did not have an impact on the consolidated financial statements. The Company had $430.7 million in cash and cash equivalents as of September 30, 2017 and reported a net loss of $127.3 million for the nine months ended September 30, 2017 . Historically, the Company has funded its operations through public offerings of equity securities and debt financings. To date, the Company has not generated material revenue from ALIS. The Company does not expect to generate material revenue unless or until marketing approval is received for ALIS. Accordingly, the Company expects to continue to incur losses while funding research and development (R&D) activities, regulatory submissions, potential commercial launch activities and general and administrative expenses. The Company expects its future cash requirements to be substantial, and the Company will need to raise additional capital to fund operations, to develop and commercialize ALIS, to develop INS1007 and INS1009 and to develop, acquire, in-license or co-promote other products that address orphan or rare diseases. ASU 2014-15 requires the Company to evaluate whether it has sufficient resources to fund operations for the next 12 months from the filing date without regard to whether or not it can raise capital in the future. The Company believes it currently has sufficient funds to meet its financial needs for at least the next 12 months. In September 2017, the Company completed an underwritten offering of 14.1 million shares of its common stock for cash proceeds of $377.7 million , net of fees and expenses related to the offering. The Company will be opportunistic in raising additional capital within the next 12 months and may do so through equity or debt financing(s), strategic transactions or otherwise. The source, timing and availability of any future financing or other transaction will depend principally upon continued progress in the Company’s regulatory, development and pre-commercial activities. Any equity or debt financing will also be contingent upon equity and debt market conditions and interest rates at the time. If the Company is unable to obtain sufficient additional funds when required, the Company may be forced to delay, restrict or eliminate all or a portion of its R&D programs, pre-commercialization activities, or dispose of assets or technology. In March 2016, the FASB issued ASU 2016-9, Improvements to Employee Share-Based Payment Accounting , which amends Accounting Standards Codification (ASC) Topic 718, Compensation—Stock Compensation . ASU 2016-9 simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU 2016-9 was effective for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. The Company adopted ASU 2016-9 in the first quarter of 2017. The impact of the adoption was not material to the consolidated financial statements. |
Identifiable Intangible Asset
Identifiable Intangible Asset | 9 Months Ended |
Sep. 30, 2017 | |
Goodwill and Intangible Assets Disclosure [Abstract] | |
Identifiable Intangible Asset | Identifiable Intangible Asset The Company believes there are no indicators of impairment relating to its in-process research and development intangible asset as of September 30, 2017 . |
Accrued Expenses
Accrued Expenses | 9 Months Ended |
Sep. 30, 2017 | |
Payables and Accruals [Abstract] | |
Accrued Expenses | Accrued Expenses Accrued expenses consist of the following: As of September 30, As of December 31, (in thousands) Accrued clinical trial expenses $ 8,560 $ 7,071 Accrued compensation 6,634 6,937 Accrued professional fees 2,057 1,604 Accrued technical operation expenses 742 591 Accrued interest payable 424 438 Other accrued expenses 385 181 $ 18,802 $ 16,822 |
Debt
Debt | 9 Months Ended |
Sep. 30, 2017 | |
Debt Disclosure [Abstract] | |
Debt | Debt On September 30, 2016, the Company and its domestic subsidiaries, as co-borrowers, entered into an Amended and Restated Loan and Security Agreement (the A&R Loan Agreement) with Hercules Capital, Inc. (Hercules). The A&R Loan Agreement included a total commitment from Hercules of up to $55.0 million , of which $25.0 million was previously outstanding. The amount of borrowings was increased by $10.0 million to an aggregate total of $35.0 million on September 30, 2016. An additional $20.0 million was available at the Company’s option through June 30, 2017 subject to certain conditions, including the payment of a facility fee of 0.375% . The Company exercised this option in early October 2016 and borrowed an additional $20.0 million in connection with its upfront payment obligation under the license agreement with AstraZeneca AB. The interest rate for the term is floating and is calculated as the greater of (i) 9.25% or (ii) 9.25% plus the sum of the US prime rate minus 4.50% , along with a backend fee of 4.15% of the aggregate principal amount outstanding and an aggregate facility fee of $337,500 . The maturity date of the loan facility was also extended to October 1, 2020. In connection with the Company generating and announcing top-line data from the CONVERT study on September 5, 2017 that supports the filing of a New Drug Application (NDA), along with the completion of the equity financing, the interest-only period was automatically extended through May 1, 2019 and the Company's requirement to have a consolidated minimum cash liquidity in an amount no less than $25.0 million was eliminated. In addition, pursuant to the A&R Loan Agreement, Hercules has the right to participate, in an aggregate amount of up to $2.0 million , in a subsequent private financing that involves the issuance of our equity securities. In connection with the A&R Loan Agreement, the Company granted Hercules a first position lien on all of the Company’s assets, excluding intellectual property. Prepayment of the loans made pursuant to the A&R Loan Agreement is subject to penalty. The back-end fee of 4.15% on the aggregate outstanding principal balance is being charged to interest expense (and accreted to the debt) using the effective interest method over the life of the A&R Loan Agreement. Debt issuance fees paid to Hercules were recorded as a discount on the debt and are being amortized to interest expense using the effective interest method over the life of the A&R Loan Agreement. The following table presents the components of the Company’s debt balance as of September 30, 2017 (in thousands): Notes payable $ 55,000 Accretion of back-end fee on debt 677 Debt issuance costs, unamortized (289 ) Debt, long-term $ 55,388 As of September 30, 2017 , future principal repayments of the debt for each of the fiscal years through maturity were as follows (in thousands): Year Ending December 31: 2017 $ — 2018 — 2019 13,399 2020 41,601 $ 55,000 The estimated fair value of the debt (categorized as a Level 2 liability for fair value measurement purposes) is determined using current market factors and the ability of the Company to obtain debt at comparable terms to those that are currently in place. The Company believes the estimated fair value at September 30, 2017 approximates the carrying amount. |
Shareholders' Equity
Shareholders' Equity | 9 Months Ended |
Sep. 30, 2017 | |
Stockholders' Equity Note [Abstract] | |
Shareholders' Equity | Shareholders’ Equity Common Stock — As of September 30, 2017 , the Company had 500,000,000 shares of common stock authorized with a par value of $0.01 and 76,568,368 shares of common stock issued and outstanding. In addition, as of September 30, 2017 , the Company had reserved 8,601,293 shares of common stock for issuance upon the exercise of outstanding stock options and 46,914 shares of common stock for issuance upon the vesting of RSUs. On September 6, 2017 , the Company completed an underwritten public offering of 14,123,150 shares of the Company’s common stock, which included the underwriter’s exercise in full of its over-allotment option of 1,842,150 shares, at a price to the public of $28.50 per share. The Company’s net proceeds from the sale of the shares, after deducting the underwriter’s discount and offering expenses of $24.8 million , were $ 377.7 million . Preferred Stock — As of September 30, 2017 , the Company had 200,000,000 shares of preferred stock authorized with a par value of $0.01 and no shares of preferred stock were issued and outstanding. |
Stock-Based Compensation
Stock-Based Compensation | 9 Months Ended |
Sep. 30, 2017 | |
Share-based Compensation [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation The Company’s current equity compensation plan, the 2017 Incentive Plan, was approved by shareholders at the Company’s Annual Meeting of Shareholders on May 18, 2017. The 2017 Incentive Plan is administered by the Compensation Committee and the Board of Directors of the Company. Under the terms of the 2017 Incentive Plan, the Company is authorized to grant a variety of incentive awards based on its common stock, including stock options (both incentive stock options and non-qualified stock options), RSUs, performance options/shares and other stock awards, as well as pay incentive bonuses to eligible employees and non-employee directors. On May 18, 2017, upon the approval of the 2017 Incentive Plan by shareholders, 5,000,000 shares were authorized for issuance thereunder, plus any shares subject to then-outstanding awards under the 2015 Incentive Plan and the 2013 Incentive Plan that subsequently were canceled, terminated unearned, expired, were forfeited, lapsed for any reason or were settled in cash without the delivery of shares. As of September 30, 2017 , 4,929,910 shares remained for future issuance under the 2017 Incentive Plan. The 2017 Incentive Plan will terminate on April 3, 2027 unless it is extended or terminated earlier pursuant to its terms. In addition, from time to time, the Company makes inducement grants of stock options. These awards are made pursuant to the NASDAQ inducement grant exception as a component of new hires’ employment compensation in connection with the Company’s equity grant program. During the nine months ended September 30, 2017 , the Company granted inducement stock options covering 236,370 shares of the Company's common stock to new employees. Stock Options - The Company calculates the fair value of stock options granted using the Black-Scholes valuation model. The following table summarizes the Company’s grant date fair value and assumptions used in determining the fair value of all stock options granted: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Volatility 72%-73% 75%-76% 72%-74% 75%-77% Risk-free interest rate 1.73%-1.93% 1.00%-1.18% 1.73%-1.99% 1.00%-1.73% Dividend yield 0.0% 0.0% 0.0% 0.0% Expected option term (in years) 6.25 6.25 6.25 6.25 Weighted average fair value of stock options granted $9.59 $7.79 $10.18 $8.74 For each period presented, the volatility factor was based on the Company’s historical volatility during the expected option term. Estimated forfeitures are based on the actual percentage of option forfeitures since the closing of the Company’s merger with Transave, Inc. in December 2010. From time to time, the Company grants performance-condition options to certain of its employees. Vesting of these options is subject to the Company achieving certain performance criteria established at the date of grant and the grantees fulfilling a service condition (continued employment). As of September 30, 2017 , the Company had performance options totaling 133,334 shares outstanding which had not yet met the recognition criteria. The following table summarizes the Company’s aggregate stock option activity for the nine months ended September 30, 2017 : Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value (in thousands) Options outstanding at December 31, 2016 7,116,706 $ 13.30 Granted 2,207,390 $ 15.42 Exercised (336,135 ) $ 8.78 Forfeited or expired (386,668 ) $ 15.59 Options outstanding at September 30, 2017 8,601,293 $ 13.92 7.65 $ 148,771 Vested and expected to vest at September 30, 2017 8,269,230 $ 13.88 7.60 $ 143,327 Exercisable at September 30, 2017 3,904,073 $ 12.46 6.40 $ 73,193 The total intrinsic value of stock options exercised during the three months ended September 30, 2017 and 2016 was $1.4 million and $0.0 million , respectively, and during the nine months ended September 30, 2017 and 2016 was $3.5 million and $0.1 million , respectively. As of September 30, 2017 , there was $31.5 million of unrecognized compensation expense related to unvested stock options which is expected to be recognized over a weighted average period of 2.7 years. Included in unrecognized compensation expense was $1.1 million related to outstanding performance-condition options. The following table summarizes the range of exercise prices and the number of stock options outstanding and exercisable: Outstanding as of September 30, 2017 Exercisable as of September 30, 2017 Range of Exercise Prices ($) Number of Options Weighted Average Remaining Contractual Term (in years) Weighted Average Exercise Price ($) Number of Options Weighted Average Exercise Price ($) 3.03 4.55 988,195 4.89 3.59 988,195 3.59 6.90 6.90 137,577 5.47 6.90 100,077 6.90 6.96 10.85 1,081,121 8.55 10.76 289,330 10.52 11.14 12.58 1,095,757 6.65 12.17 735,792 12.16 12.66 13.58 185,880 7.76 13.24 89,704 13.29 13.67 13.67 865,660 9.27 13.67 — — 13.94 15.91 862,300 8.01 14.97 339,372 14.55 16.07 16.16 1,009,781 7.93 16.13 463,410 16.12 16.19 17.16 871,266 9.34 17.10 31,741 16.30 17.24 27.38 1,503,756 7.41 21.20 866,452 21.13 Restricted Stock and Restricted Stock Units — The Company may grant restricted stock (RS) and RSUs to eligible employees, including its executives, and non-employee directors. Each share of RS vests, and each RSU represents a right to receive one share of the Company’s common stock, upon the completion of a specific period of continued service or achievement of a certain milestone. RS and RSU awards granted are valued at the market price of the Company’s common stock on the date of grant. The Company recognizes noncash compensation expense for the fair values of these RS and RSUs on a straight-line basis over the requisite service period of these awards. The following table summarizes the Company’s RSU award activity during the nine months ended September 30, 2017 : Number of RSUs Weighted Average Grant Price ($) Outstanding at December 31, 2016 89,194 10.85 Granted 46,914 17.16 Released (89,194 ) (10.85 ) Outstanding at September 30, 2017 46,914 17.16 The following table summarizes the aggregate stock-based compensation recorded in the Consolidated Statements of Comprehensive Loss related to stock options and RSUs during the three and nine months ended September 30, 2017 and 2016 : Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (in millions) Research and development expenses $ 1.8 $ 1.7 $ 4.8 $ 4.6 General and administrative expenses 2.9 3.4 8.5 9.3 Total $ 4.7 $ 5.1 $ 13.3 $ 13.9 |
Income Taxes
Income Taxes | 9 Months Ended |
Sep. 30, 2017 | |
Income Tax Disclosure [Abstract] | |
Income Taxes | Income Taxes The Company’s provision for income taxes was $27,000 and $94,000 for the three and nine months ended September 30, 2017 , respectively, and $25,000 and $71,000 for the three and nine months ended September 30, 2016 , respectively. The provision for income taxes in all periods was a result of certain of the Company’s subsidiaries in Europe, which had taxable income during the three and nine months ended September 30, 2017 and 2016 . In jurisdictions where the Company has net losses, there was a full valuation allowance recorded against the Company’s deferred tax assets and therefore no tax benefit was recorded. The Company is subject to US federal, US state and foreign income taxes. The statute of limitations for tax audit is open for the Company’s US federal tax returns for the years ended 2013 and later and is generally open for certain states for the years 2012 and later. The Company has incurred net operating losses since inception, except for 2009. Loss carryforwards are subject to audit in any tax year in which those losses are utilized, notwithstanding the year of origin. As of September 30, 2017 and December 31, 2016 , the Company had recorded no reserves for unrecognized income tax benefits, nor had it recorded any accrued interest or penalties related to uncertain tax positions. The Company does not anticipate any material changes in the amount of unrecognized tax positions over the next 12 months. |
Commitments and Contingencies
Commitments and Contingencies | 9 Months Ended |
Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies The Company has an operating lease for office and laboratory space located in Bridgewater, NJ, its corporate headquarters, for which the initial lease term expires in November 2019. Future minimum rental payments under this lease are $2.2 million . In July 2016, the Company signed an operating lease for additional laboratory space located in Bridgewater, NJ for which the initial lease term expires in December 2021. Future minimum rental payments under this lease are $2.0 million . Rent expense charged to operations was $0.4 million for both the three months ended September 30, 2017 and 2016 , and $1.1 million and $0.9 million for the nine months ended September 30, 2017 and 2016 , respectively. Future minimum rental payments required under the Company’s operating leases for the period from October 1, 2017 to December 31, 2017 and for each of the five years thereafter are as follows (in thousands): Year Ending December 31: 2017 (remaining) $ 377 2018 1,520 2019 1,421 2020 477 2021 498 2022 — $ 4,293 Purchase Commitments In September 2017, the Company increased its purchase commitments made in the normal course of business with contract manufacturing organizations (CMOs) and various other suppliers related to the production requirements for ALIS. These purchase commitments have increased as a result of the release of top-line results from the CONVERT study. Legal Proceedings On July 15, 2016, a lawsuit captioned Hoey v. Insmed Incorporated, et al, No. 3:16-cv-04323-FLW-TJB (D.N.J. July 15, 2016) was filed in the US District Court for the District of New Jersey on behalf of a putative class of investors who purchased the Company’s common stock from March 18, 2013 through June 8, 2016. The complaint alleged that the Company and certain of its executives violated Sections 10(b) and 20(a) of the Securities Exchange Act of 1934 (Exchange Act) by misrepresenting and/or omitting the likelihood of the European Medicines Agency (EMA) approving the Company’s European marketing authorization application (MAA) for use of ALIS in the treatment of NTM lung disease and the likelihood of commercialization of ALIS in Europe. On October 25, 2016, the Court issued an order appointing Bucks County Employees Retirement Fund as lead plaintiff for the putative class. On December 15, 2016, the lead plaintiff filed an amended complaint that shortens the putative class period for the Exchange Act claims to March 26, 2014 through June 8, 2016 and adds claims under Sections 11, 12, and 15 of the Securities Act of 1933 (Securities Act) on behalf of a putative class of investors who purchased common stock in or traceable to the Company’s March 31, 2015 public offering. The amended complaint names as defendants in the Securities Act claims the Company, certain directors and officers, and the investment banks who served as underwriters in connection with the secondary offering. The amended complaint alleges defendants violated the Securities Act by using a purportedly misleading definition of “culture conversion” and supposedly failing to disclose in the offering materials purported flaws in its Phase 2 study that made the secondary offering risky or speculative. The amended complaint seeks damages in an unspecified amount. The Company moved to dismiss the amended complaint on March 1, 2017. The lead plaintiff opposed the motion on May 17, 2017 and the Company provided its reply brief on July 11, 2017. On July 20, 2017, the plaintiff asked for leave to file a sur-reply in further opposition to the Company’s motion to dismiss the amended complaint, which the Company has opposed. The Company believes that the allegations in the complaints are without merit and intends to defend the lawsuit vigorously; however, there can be no assurance regarding the ultimate outcome of the lawsuit. From time to time, the Company is a party to various other lawsuits, claims and other legal proceedings that arise in the ordinary course of business. While the outcomes of these matters are uncertain, management does not expect that the ultimate costs to resolve these matters will have a material adverse effect on the Company’s consolidated financial position, results of operations or cash flows. |
Subsequent Event
Subsequent Event | 9 Months Ended |
Sep. 30, 2017 | |
Subsequent Events [Abstract] | |
Subsequent Event | Subsequent Event In October 2017, the Company exercised an option to buy-down the future royalties that will be payable to PARI Pharma GmbH (PARI). Pursuant to the existing licensing agreement, PARI is entitled to receive royalty payments in the mid-single digits on the annual global net sales of ALIS, subject to certain specified annual minimum royalties. The royalty buy-down will enable the Company to reduce the royalty payments due to PARI based on the annual global net sales of ALIS. The payment to PARI will be included as a component of general and administrative expenses in the fourth quarter of 2017. |
Summary of Significant Accoun16
Summary of Significant Accounting Policies (Policies) | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Fair Value Measurements | Fair Value Measurements - The Company categorizes its financial assets and liabilities measured and reported at fair value in the financial statements on a recurring basis based upon the level of judgment associated with the inputs used to measure their fair value. Hierarchical levels, which are directly related to the amount of subjectivity associated with the inputs used to determine the fair value of financial assets and liabilities, are as follows: • Level 1 — Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date. • Level 2 — Inputs (other than quoted prices included in Level 1) are either directly or indirectly observable for the assets or liability through correlation with market data at the measurement date and for the duration of the instrument’s anticipated life. • Level 3 — Inputs reflect management’s best estimate of what market participants would use in pricing the asset or liability at the measurement date. Consideration is given to the risk inherent in the valuation technique and the risk inherent in the inputs to the model. Each major category of financial assets and liabilities measured at fair value on a recurring basis are categorized based upon the lowest level of significant input to the valuations. The fair value hierarchy also requires an entity to maximize the use of observable inputs and minimize the use of unobservable inputs when measuring fair value. Financial instruments in Level 1 generally include US treasuries and mutual funds listed in active markets. The Company’s only financial assets and liabilities which were measured at fair value as of September 30, 2017 and December 31, 2016 were Level 1 and such assets were comprised of cash and cash equivalents of $430.7 million and $162.6 million , respectively. The Company’s cash and cash equivalents permit daily redemption and the fair values of these investments are based upon the quoted prices in active markets provided by the holding financial institutions. Cash equivalents consist of liquid investments with a maturity of three months or less from the date of purchase. The Company recognizes transfers between levels within the fair value hierarchy, if any, at the end of each quarter. There were no transfers in or out of Level 1, Level 2 or Level 3 during the three and nine months ended September 30, 2017 and 2016 , respectively. As of September 30, 2017 and December 31, 2016 , the Company held no securities that were in an unrealized gain or loss position. The Company reviews the status of each security quarterly to determine whether an other-than-temporary impairment has occurred. In making its determination, the Company considers a number of factors, including: (1) the significance of the decline; (2) whether the securities were rated below investment grade; (3) how long the securities have been in an unrealized loss position; and (4) the Company’s ability and intent to retain the investment for a sufficient period of time for it to recover. |
Net Loss Per Share | Net Loss Per Share - Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding during the period. Diluted net loss per share is computed by dividing net loss by the weighted average number of common shares and other dilutive securities outstanding during the period. Potentially dilutive securities from stock options and restricted stock units (RSUs) would be anti-dilutive as the Company incurred a net loss. Potentially dilutive common shares resulting from the assumed exercise of outstanding stock options are determined based on the treasury stock method. The following table sets forth the reconciliation of the weighted average number of common shares used to compute basic and diluted net loss per share for the three and nine months ended September 30, 2017 and 2016 : Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (in thousands, except per share amounts) Numerator: Net loss $ (45,179 ) $ (37,760 ) $ (127,265 ) $ (107,871 ) Denominator: Weighted average common shares used in calculation of basic net loss per share: 65,312 61,878 63,199 61,871 Effect of dilutive securities: Common stock options — — — — RSUs — — — — Weighted average common shares outstanding used in calculation of diluted net loss per share 65,312 61,878 63,199 61,871 Net loss per share: Basic and Diluted $ (0.69 ) $ (0.61 ) $ (2.01 ) $ (1.74 ) The following potentially dilutive securities have been excluded from the computations of diluted weighted average common shares outstanding as of September 30, 2017 and 2016 as their effect would have been anti-dilutive (in thousands): 2017 2016 Stock options to purchase common stock 8,601 7,306 Unvested RSUs 47 89 |
Recently Adopted Accounting Pronouncements | Recently Adopted Accounting Pronouncements - In August 2014, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) No. 2014-15, Presentation of Financial Statements—Going Concern (Subtopic 205-40): Disclosure of Uncertainties about an Entity’s Ability to Continue as a Going Concern , which defines management’s responsibility to perform interim and annual assessments of an entity’s ability to continue as a going concern, and to provide related footnote disclosures if there is substantial doubt about its ability to continue as a going concern. The new standard was effective for the annual period ending after December 15, 2016, and for interim periods thereafter. The Company adopted ASU 2014-15 in the fourth quarter of 2016 , which had no impact on the Company’s consolidated financial statements. The interim assessment during the first three quarters of 2017 did not have an impact on the consolidated financial statements. The Company had $430.7 million in cash and cash equivalents as of September 30, 2017 and reported a net loss of $127.3 million for the nine months ended September 30, 2017 . Historically, the Company has funded its operations through public offerings of equity securities and debt financings. To date, the Company has not generated material revenue from ALIS. The Company does not expect to generate material revenue unless or until marketing approval is received for ALIS. Accordingly, the Company expects to continue to incur losses while funding research and development (R&D) activities, regulatory submissions, potential commercial launch activities and general and administrative expenses. The Company expects its future cash requirements to be substantial, and the Company will need to raise additional capital to fund operations, to develop and commercialize ALIS, to develop INS1007 and INS1009 and to develop, acquire, in-license or co-promote other products that address orphan or rare diseases. ASU 2014-15 requires the Company to evaluate whether it has sufficient resources to fund operations for the next 12 months from the filing date without regard to whether or not it can raise capital in the future. The Company believes it currently has sufficient funds to meet its financial needs for at least the next 12 months. In September 2017, the Company completed an underwritten offering of 14.1 million shares of its common stock for cash proceeds of $377.7 million , net of fees and expenses related to the offering. The Company will be opportunistic in raising additional capital within the next 12 months and may do so through equity or debt financing(s), strategic transactions or otherwise. The source, timing and availability of any future financing or other transaction will depend principally upon continued progress in the Company’s regulatory, development and pre-commercial activities. Any equity or debt financing will also be contingent upon equity and debt market conditions and interest rates at the time. If the Company is unable to obtain sufficient additional funds when required, the Company may be forced to delay, restrict or eliminate all or a portion of its R&D programs, pre-commercialization activities, or dispose of assets or technology. In March 2016, the FASB issued ASU 2016-9, Improvements to Employee Share-Based Payment Accounting , which amends Accounting Standards Codification (ASC) Topic 718, Compensation—Stock Compensation . ASU 2016-9 simplifies several aspects of the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of cash flows. ASU 2016-9 was effective for fiscal years beginning after December 15, 2016, and interim periods within those fiscal years. The Company adopted ASU 2016-9 in the first quarter of 2017. The impact of the adoption was not material to the consolidated financial statements. |
Summary of Significant Accoun17
Summary of Significant Accounting Policies (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Accounting Policies [Abstract] | |
Reconciliation of the Weighted Average Number of Shares Used to Compute Basic and Diluted Net Loss per Share | The following table sets forth the reconciliation of the weighted average number of common shares used to compute basic and diluted net loss per share for the three and nine months ended September 30, 2017 and 2016 : Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (in thousands, except per share amounts) Numerator: Net loss $ (45,179 ) $ (37,760 ) $ (127,265 ) $ (107,871 ) Denominator: Weighted average common shares used in calculation of basic net loss per share: 65,312 61,878 63,199 61,871 Effect of dilutive securities: Common stock options — — — — RSUs — — — — Weighted average common shares outstanding used in calculation of diluted net loss per share 65,312 61,878 63,199 61,871 Net loss per share: Basic and Diluted $ (0.69 ) $ (0.61 ) $ (2.01 ) $ (1.74 ) |
Potentially Dilutive Securities Excluded from Computations of Diluted Weighted Average Common Shares Outstanding | The following potentially dilutive securities have been excluded from the computations of diluted weighted average common shares outstanding as of September 30, 2017 and 2016 as their effect would have been anti-dilutive (in thousands): 2017 2016 Stock options to purchase common stock 8,601 7,306 Unvested RSUs 47 89 |
Accrued Expenses (Tables)
Accrued Expenses (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Payables and Accruals [Abstract] | |
Schedule of Accrued Expenses | Accrued expenses consist of the following: As of September 30, As of December 31, (in thousands) Accrued clinical trial expenses $ 8,560 $ 7,071 Accrued compensation 6,634 6,937 Accrued professional fees 2,057 1,604 Accrued technical operation expenses 742 591 Accrued interest payable 424 438 Other accrued expenses 385 181 $ 18,802 $ 16,822 |
Debt (Tables)
Debt (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Debt Disclosure [Abstract] | |
Components of Debt Balance | The following table presents the components of the Company’s debt balance as of September 30, 2017 (in thousands): Notes payable $ 55,000 Accretion of back-end fee on debt 677 Debt issuance costs, unamortized (289 ) Debt, long-term $ 55,388 |
Schedule of Future Principal Repayments of Debt | As of September 30, 2017 , future principal repayments of the debt for each of the fiscal years through maturity were as follows (in thousands): Year Ending December 31: 2017 $ — 2018 — 2019 13,399 2020 41,601 $ 55,000 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Share-based Compensation [Abstract] | |
Summary of Fair Value Assumptions for Stock Options | The following table summarizes the Company’s grant date fair value and assumptions used in determining the fair value of all stock options granted: Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 Volatility 72%-73% 75%-76% 72%-74% 75%-77% Risk-free interest rate 1.73%-1.93% 1.00%-1.18% 1.73%-1.99% 1.00%-1.73% Dividend yield 0.0% 0.0% 0.0% 0.0% Expected option term (in years) 6.25 6.25 6.25 6.25 Weighted average fair value of stock options granted $9.59 $7.79 $10.18 $8.74 |
Summary of Stock Option Activity | The following table summarizes the Company’s aggregate stock option activity for the nine months ended September 30, 2017 : Number of Shares Weighted Average Exercise Price Weighted Average Remaining Contractual Life in Years Aggregate Intrinsic Value (in thousands) Options outstanding at December 31, 2016 7,116,706 $ 13.30 Granted 2,207,390 $ 15.42 Exercised (336,135 ) $ 8.78 Forfeited or expired (386,668 ) $ 15.59 Options outstanding at September 30, 2017 8,601,293 $ 13.92 7.65 $ 148,771 Vested and expected to vest at September 30, 2017 8,269,230 $ 13.88 7.60 $ 143,327 Exercisable at September 30, 2017 3,904,073 $ 12.46 6.40 $ 73,193 |
Summary of Exercise Price and Number of Stock Options Exercisable | The following table summarizes the range of exercise prices and the number of stock options outstanding and exercisable: Outstanding as of September 30, 2017 Exercisable as of September 30, 2017 Range of Exercise Prices ($) Number of Options Weighted Average Remaining Contractual Term (in years) Weighted Average Exercise Price ($) Number of Options Weighted Average Exercise Price ($) 3.03 4.55 988,195 4.89 3.59 988,195 3.59 6.90 6.90 137,577 5.47 6.90 100,077 6.90 6.96 10.85 1,081,121 8.55 10.76 289,330 10.52 11.14 12.58 1,095,757 6.65 12.17 735,792 12.16 12.66 13.58 185,880 7.76 13.24 89,704 13.29 13.67 13.67 865,660 9.27 13.67 — — 13.94 15.91 862,300 8.01 14.97 339,372 14.55 16.07 16.16 1,009,781 7.93 16.13 463,410 16.12 16.19 17.16 871,266 9.34 17.10 31,741 16.30 17.24 27.38 1,503,756 7.41 21.20 866,452 21.13 |
Summary of RSU Activity | The following table summarizes the Company’s RSU award activity during the nine months ended September 30, 2017 : Number of RSUs Weighted Average Grant Price ($) Outstanding at December 31, 2016 89,194 10.85 Granted 46,914 17.16 Released (89,194 ) (10.85 ) Outstanding at September 30, 2017 46,914 17.16 |
Summary of Allocation of Employee Stock-Based Compensation | The following table summarizes the aggregate stock-based compensation recorded in the Consolidated Statements of Comprehensive Loss related to stock options and RSUs during the three and nine months ended September 30, 2017 and 2016 : Three Months Ended September 30, Nine Months Ended September 30, 2017 2016 2017 2016 (in millions) Research and development expenses $ 1.8 $ 1.7 $ 4.8 $ 4.6 General and administrative expenses 2.9 3.4 8.5 9.3 Total $ 4.7 $ 5.1 $ 13.3 $ 13.9 |
Commitments and Contingencies (
Commitments and Contingencies (Tables) | 9 Months Ended |
Sep. 30, 2017 | |
Commitments and Contingencies Disclosure [Abstract] | |
Schedule of Future Minimum Rental Payments Required Under Operating Leases | Future minimum rental payments required under the Company’s operating leases for the period from October 1, 2017 to December 31, 2017 and for each of the five years thereafter are as follows (in thousands): Year Ending December 31: 2017 (remaining) $ 377 2018 1,520 2019 1,421 2020 477 2021 498 2022 — $ 4,293 |
Summary of Significant Accoun22
Summary of Significant Accounting Policies - Fair Value Measurements (Details) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017USD ($)security | Sep. 30, 2016USD ($) | Sep. 30, 2017USD ($)security | Sep. 30, 2016USD ($) | Dec. 31, 2016USD ($)security | |
Accounting Policies [Abstract] | |||||
Cash and cash equivalents | $ 430,700,000 | $ 430,700,000 | $ 162,600,000 | ||
Fair value transfers in or out of Level 1, Level 2, or Level 3 | $ 0 | $ 0 | $ 0 | $ 0 | |
Securities in an unrealized gain or loss position | security | 0 | 0 | 0 |
Summary of Significant Accoun23
Summary of Significant Accounting Policies - Net Loss Per Common Share (Details) - USD ($) $ / shares in Units, shares in Thousands, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Numerator: | ||||
Net loss | $ (45,179) | $ (37,760) | $ (127,265) | $ (107,871) |
Denominator: | ||||
Weighted average common shares used in calculation of basic net loss per share: | 65,312 | 61,878 | 63,199 | 61,871 |
Effect of dilutive securities: | ||||
Weighted average common shares outstanding used in calculation of diluted net loss per share | 65,312 | 61,878 | 63,199 | 61,871 |
Net loss per share: | ||||
Basic and Diluted | $ (0.69) | $ (0.61) | $ (2.01) | $ (1.74) |
Common stock options | ||||
Effect of dilutive securities: | ||||
Dilutive securities | 0 | 0 | 0 | 0 |
RSUs | ||||
Effect of dilutive securities: | ||||
Dilutive securities | 0 | 0 | 0 | 0 |
Summary of Significant Accoun24
Summary of Significant Accounting Policies - Anti-dilutive Securities (Details) - shares shares in Thousands | 9 Months Ended | |
Sep. 30, 2017 | Sep. 30, 2016 | |
Stock options to purchase common stock | ||
Anti-dilutive securities excluded from computations of diluted weighted-average common shares outstanding | ||
Potentially dilutive securities excluded from computations of diluted weighted-average shares outstanding | 8,601 | 7,306 |
Unvested RSUs | ||
Anti-dilutive securities excluded from computations of diluted weighted-average common shares outstanding | ||
Potentially dilutive securities excluded from computations of diluted weighted-average shares outstanding | 47 | 89 |
Summary of Significant Accoun25
Summary of Significant Accounting Policies - Recently Adopted Accounting Pronouncements (Details) - USD ($) $ in Thousands | Sep. 06, 2017 | Sep. 30, 2017 | Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 |
Accounting Policies [Abstract] | |||||||
Cash and cash equivalents | $ 430,700 | $ 430,700 | $ 430,700 | $ 162,600 | |||
Net loss | $ 45,179 | $ 37,760 | 127,265 | $ 107,871 | |||
Shares issued under underwritten public offering (in shares) | 14,123,150 | 14,100,000 | |||||
Proceeds from issuance of common stock, net | $ 377,700 | $ 377,700 | $ 377,703 | $ 0 |
Accrued Expenses (Details)
Accrued Expenses (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Payables and Accruals [Abstract] | ||
Accrued clinical trial expenses | $ 8,560 | $ 7,071 |
Accrued compensation | 6,634 | 6,937 |
Accrued professional fees | 2,057 | 1,604 |
Accrued technical operation expenses | 742 | 591 |
Accrued interest payable | 424 | 438 |
Other accrued expenses | 385 | 181 |
Total accrued expenses | $ 18,802 | $ 16,822 |
Debt - Narrative (Details)
Debt - Narrative (Details) - A&R Loan Agreement - USD ($) | Sep. 30, 2016 | Oct. 31, 2016 | Sep. 30, 2017 | Sep. 29, 2016 |
Debt | ||||
Maximum borrowing capacity of term loan | $ 55,000,000 | |||
Amount outstanding | 35,000,000 | $ 25,000,000 | ||
Amount of borrowings during the period | $ 10,000,000 | |||
Facility fee paid (as a percent) | 0.375% | |||
Interest rate (as a percent) | 9.25% | |||
Backend fee (as a percent) | 4.15% | 4.15% | ||
Facility fee paid | $ 337,500 | |||
Minimum cash liquidity requirement eliminated | $ 25,000,000 | |||
Limit on lender's participation rights in certain future private equity financings | $ 2,000,000 | |||
License Agreement with AstraZeneca | ||||
Debt | ||||
Amount borrowed during period | $ 20,000,000 | |||
Prime Rate | ||||
Debt | ||||
Basis spread (as a percent) | (4.50%) |
Debt - Components of Debt (Deta
Debt - Components of Debt (Details) - USD ($) $ in Thousands | Sep. 30, 2017 | Dec. 31, 2016 |
Debt: | ||
Notes payable | $ 55,000 | |
Accretion of back-end fee on debt | 677 | |
Debt issuance costs, unamortized | (289) | |
Debt, long-term | $ 55,388 | $ 54,791 |
Debt - Future Principal Repayme
Debt - Future Principal Repayments of Debt (Details) $ in Thousands | Sep. 30, 2017USD ($) |
Debt Disclosure [Abstract] | |
2,017 | $ 0 |
2,018 | 0 |
2,019 | 13,399 |
2,020 | 41,601 |
Total | $ 55,000 |
Shareholders' Equity (Details)
Shareholders' Equity (Details) - USD ($) $ / shares in Units, $ in Thousands | Sep. 06, 2017 | Sep. 30, 2017 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 |
Class of Stock [Line Items] | |||||
Common stock, authorized shares (in shares) | 500,000,000 | 500,000,000 | 500,000,000 | ||
Common stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | $ 0.01 | ||
Common stock, issued shares (in shares) | 76,568,368 | 76,568,368 | 62,019,889 | ||
Common stock, outstanding shares (in shares) | 76,568,368 | 76,568,368 | 62,019,889 | ||
Shares issued under underwritten public offering (in shares) | 14,123,150 | 14,100,000 | |||
Shares exercised in full of over-allotment option by underwriter (in shares) | 1,842,150 | ||||
Share price (in dollars per share) | $ 28.50 | ||||
Underwriter's discount and offering expenses | $ 24,800 | ||||
Net proceeds from sale of shares | $ 377,700 | $ 377,700 | $ 377,703 | $ 0 | |
Preferred stock, authorized (in shares) | 200,000,000 | 200,000,000 | |||
Preferred stock, par value (in dollars per share) | $ 0.01 | $ 0.01 | |||
Preferred stock, shares issued (in shares) | 0 | 0 | |||
Preferred stock, shares outstanding (in shares) | 0 | 0 | |||
Stock options to purchase common stock | |||||
Class of Stock [Line Items] | |||||
Common stock shares reserved for issuance (in shares) | 8,601,293 | 8,601,293 | |||
Unvested RSUs | |||||
Class of Stock [Line Items] | |||||
Common stock shares reserved for issuance (in shares) | 46,914 | 46,914 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Details) - shares | 9 Months Ended | |
Sep. 30, 2017 | May 18, 2017 | |
Share-based Compensation [Abstract] | ||
Shares of common stock, maximum authorized for issuance (in shares) | 5,000,000 | |
Shares available for grant (in shares) | 4,929,910 | |
Inducement stock options granted to new employees (in shares) | 236,370 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock Options (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Number of Shares | ||||
Options outstanding beginning of the year (in shares) | 7,116,706 | |||
Granted (in shares) | 2,207,390 | |||
Exercised (in shares) | (336,135) | |||
Forfeited or expired (in shares) | (386,668) | |||
Options outstanding end of the year (in shares) | 8,601,293 | 8,601,293 | ||
Vested and expected to vest (in shares) | 8,269,230 | 8,269,230 | ||
Exercisable (in shares) | 3,904,073 | 3,904,073 | ||
Weighted Average Exercise Price | ||||
Options outstanding beginning of the year (in dollars per share) | $ 13.30 | |||
Granted (in dollars per share) | 15.42 | |||
Exercised (in dollars per share) | 8.78 | |||
Forfeited or expired (in dollars per share) | 15.59 | |||
Options outstanding end of the year (in dollars per share) | $ 13.92 | 13.92 | ||
Vested and expected to vest (in dollars per share) | 13.88 | 13.88 | ||
Exercisable (in dollars per share) | $ 12.46 | $ 12.46 | ||
Weighted Average Remaining Contractual Life in Years | ||||
Options outstanding | 7 years 7 months 24 days | |||
Vested and expected to vest | 7 years 7 months 6 days | |||
Exercisable | 6 years 4 months 24 days | |||
Aggregate Intrinsic Value | ||||
Options outstanding | $ 148,771 | $ 148,771 | ||
Vested and expected to vest | 143,327 | 143,327 | ||
Exercisable | $ 73,193 | $ 73,193 | ||
Stock options to purchase common stock | ||||
Fair value and assumptions used in determining fair value of stock options | ||||
Dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Expected option term (in years) | 6 years 3 months | 6 years 3 months | 6 years 3 months | 6 years 3 months |
Weighted average fair value of stock options granted (in dollars per share) | $ 9.59 | $ 7.79 | $ 10.18 | $ 8.74 |
Stock options to purchase common stock | Minimum | ||||
Fair value and assumptions used in determining fair value of stock options | ||||
Volatility | 72.00% | 75.00% | 72.00% | 75.00% |
Risk-free interest rate | 1.73% | 1.00% | 1.73% | 1.00% |
Stock options to purchase common stock | Maximum | ||||
Fair value and assumptions used in determining fair value of stock options | ||||
Volatility | 73.00% | 76.00% | 74.00% | 77.00% |
Risk-free interest rate | 1.93% | 1.18% | 1.99% | 1.73% |
Performance-condition options | ||||
Number of Shares | ||||
Options outstanding end of the year (in shares) | 133,334 | 133,334 |
Stock-Based Compensation - Rang
Stock-Based Compensation - Range of Exercise Prices (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Stock options to purchase common stock | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range | ||||
Total intrinsic value of stock options exercised during the period | $ 1.4 | $ 0 | $ 3.5 | $ 0.1 |
Unrecognized compensation expense related to unvested stock options | 31.5 | $ 31.5 | ||
Expected weighted average period for recognized and unrecognized compensation expense | 2 years 8 months 26 days | |||
Performance-condition options | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range | ||||
Unrecognized compensation expense related to unvested stock options | $ 1.1 | $ 1.1 | ||
$3.03 to $4.55 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range | ||||
Range of Exercise Prices lower range limit (in dollars per share) | $ 3.03 | |||
Range of Exercise Prices upper range limit (in dollars per share) | $ 4.55 | |||
Number of Options Outstanding (in shares) | 988,195 | 988,195 | ||
Weighted Average Remaining Contractual Term (in years) | 4 years 10 months 21 days | |||
Outstanding Options, Weighted Average Exercise Price (in dollars per share) | $ 3.59 | $ 3.59 | ||
Number of Options Exercisable (in shares) | 988,195 | 988,195 | ||
Exercisable Options, Weighted Average Exercise Price (in dollars per share) | $ 3.59 | $ 3.59 | ||
$6.90 to $6.90 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range | ||||
Range of Exercise Prices lower range limit (in dollars per share) | 6.90 | |||
Range of Exercise Prices upper range limit (in dollars per share) | $ 6.90 | |||
Number of Options Outstanding (in shares) | 137,577 | 137,577 | ||
Weighted Average Remaining Contractual Term (in years) | 5 years 5 months 18 days | |||
Outstanding Options, Weighted Average Exercise Price (in dollars per share) | $ 6.90 | $ 6.90 | ||
Number of Options Exercisable (in shares) | 100,077 | 100,077 | ||
Exercisable Options, Weighted Average Exercise Price (in dollars per share) | $ 6.90 | $ 6.90 | ||
$6.96 to $10.85 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range | ||||
Range of Exercise Prices lower range limit (in dollars per share) | 6.96 | |||
Range of Exercise Prices upper range limit (in dollars per share) | $ 10.85 | |||
Number of Options Outstanding (in shares) | 1,081,121 | 1,081,121 | ||
Weighted Average Remaining Contractual Term (in years) | 8 years 6 months 20 days | |||
Outstanding Options, Weighted Average Exercise Price (in dollars per share) | $ 10.76 | $ 10.76 | ||
Number of Options Exercisable (in shares) | 289,330 | 289,330 | ||
Exercisable Options, Weighted Average Exercise Price (in dollars per share) | $ 10.52 | $ 10.52 | ||
$11.14 to $12.58 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range | ||||
Range of Exercise Prices lower range limit (in dollars per share) | 11.14 | |||
Range of Exercise Prices upper range limit (in dollars per share) | $ 12.58 | |||
Number of Options Outstanding (in shares) | 1,095,757 | 1,095,757 | ||
Weighted Average Remaining Contractual Term (in years) | 6 years 7 months 25 days | |||
Outstanding Options, Weighted Average Exercise Price (in dollars per share) | $ 12.17 | $ 12.17 | ||
Number of Options Exercisable (in shares) | 735,792 | 735,792 | ||
Exercisable Options, Weighted Average Exercise Price (in dollars per share) | $ 12.16 | $ 12.16 | ||
$12.66 to $13.58 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range | ||||
Range of Exercise Prices lower range limit (in dollars per share) | 12.66 | |||
Range of Exercise Prices upper range limit (in dollars per share) | $ 13.58 | |||
Number of Options Outstanding (in shares) | 185,880 | 185,880 | ||
Weighted Average Remaining Contractual Term (in years) | 7 years 9 months 5 days | |||
Outstanding Options, Weighted Average Exercise Price (in dollars per share) | $ 13.24 | $ 13.24 | ||
Number of Options Exercisable (in shares) | 89,704 | 89,704 | ||
Exercisable Options, Weighted Average Exercise Price (in dollars per share) | $ 13.29 | $ 13.29 | ||
$13.67 to $13.67 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range | ||||
Range of Exercise Prices lower range limit (in dollars per share) | 13.67 | |||
Range of Exercise Prices upper range limit (in dollars per share) | $ 13.67 | |||
Number of Options Outstanding (in shares) | 865,660 | 865,660 | ||
Weighted Average Remaining Contractual Term (in years) | 9 years 3 months 9 days | |||
Outstanding Options, Weighted Average Exercise Price (in dollars per share) | $ 13.67 | $ 13.67 | ||
Number of Options Exercisable (in shares) | 0 | 0 | ||
Exercisable Options, Weighted Average Exercise Price (in dollars per share) | $ 0 | $ 0 | ||
$13.94 to $15.91 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range | ||||
Range of Exercise Prices lower range limit (in dollars per share) | 13.94 | |||
Range of Exercise Prices upper range limit (in dollars per share) | $ 15.91 | |||
Number of Options Outstanding (in shares) | 862,300 | 862,300 | ||
Weighted Average Remaining Contractual Term (in years) | 8 years 4 days | |||
Outstanding Options, Weighted Average Exercise Price (in dollars per share) | $ 14.97 | $ 14.97 | ||
Number of Options Exercisable (in shares) | 339,372 | 339,372 | ||
Exercisable Options, Weighted Average Exercise Price (in dollars per share) | $ 14.55 | $ 14.55 | ||
$16.07 to $16.16 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range | ||||
Range of Exercise Prices lower range limit (in dollars per share) | 16.07 | |||
Range of Exercise Prices upper range limit (in dollars per share) | $ 16.16 | |||
Number of Options Outstanding (in shares) | 1,009,781 | 1,009,781 | ||
Weighted Average Remaining Contractual Term (in years) | 7 years 11 months 5 days | |||
Outstanding Options, Weighted Average Exercise Price (in dollars per share) | $ 16.13 | $ 16.13 | ||
Number of Options Exercisable (in shares) | 463,410 | 463,410 | ||
Exercisable Options, Weighted Average Exercise Price (in dollars per share) | $ 16.12 | $ 16.12 | ||
$16.19 to $17.16 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range | ||||
Range of Exercise Prices lower range limit (in dollars per share) | 16.19 | |||
Range of Exercise Prices upper range limit (in dollars per share) | $ 17.16 | |||
Number of Options Outstanding (in shares) | 871,266 | 871,266 | ||
Weighted Average Remaining Contractual Term (in years) | 9 years 4 months 2 days | |||
Outstanding Options, Weighted Average Exercise Price (in dollars per share) | $ 17.10 | $ 17.10 | ||
Number of Options Exercisable (in shares) | 31,741 | 31,741 | ||
Exercisable Options, Weighted Average Exercise Price (in dollars per share) | $ 16.30 | $ 16.30 | ||
$17.24 to $27.38 | ||||
Share-based Compensation, Shares Authorized under Stock Option Plans, Exercise Price Range | ||||
Range of Exercise Prices lower range limit (in dollars per share) | 17.24 | |||
Range of Exercise Prices upper range limit (in dollars per share) | $ 27.38 | |||
Number of Options Outstanding (in shares) | 1,503,756 | 1,503,756 | ||
Weighted Average Remaining Contractual Term (in years) | 7 years 4 months 28 days | |||
Outstanding Options, Weighted Average Exercise Price (in dollars per share) | $ 21.20 | $ 21.20 | ||
Number of Options Exercisable (in shares) | 866,452 | 866,452 | ||
Exercisable Options, Weighted Average Exercise Price (in dollars per share) | $ 21.13 | $ 21.13 |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock and Restricted Stock Units (Details) - USD ($) $ / shares in Units, $ in Millions | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Stock options and RSUs | ||||
Weighted Average Grant Price | ||||
Allocated share-based compensation expense | $ 4.7 | $ 5.1 | $ 13.3 | $ 13.9 |
Stock options and RSUs | Research and development expenses | ||||
Weighted Average Grant Price | ||||
Allocated share-based compensation expense | 1.8 | 1.7 | 4.8 | 4.6 |
Stock options and RSUs | General and administrative expenses | ||||
Weighted Average Grant Price | ||||
Allocated share-based compensation expense | $ 2.9 | $ 3.4 | $ 8.5 | $ 9.3 |
Unvested RSUs | ||||
Number of RSUs | ||||
Outstanding, beginning balance (in shares) | 89,194 | |||
Granted (in shares) | 46,914 | |||
Released (in shares) | (89,194) | |||
Outstanding, ending balance (in shares) | 46,914 | 46,914 | ||
Weighted Average Grant Price | ||||
Outstanding Weighted Average Grant Price (in dollars per share) | $ 10.85 | |||
Granted (in dollars per share) | 17.16 | |||
Released (in dollars per share) | (10.85) | |||
Outstanding Weighted Average Grant Price (in dollars per share) | $ 17.16 | $ 17.16 | ||
RSUs | ||||
Stock-Based Compensation | ||||
Number of common shares each award holder is entitled to receive | 1 |
Income Taxes (Details)
Income Taxes (Details) - USD ($) | 3 Months Ended | 9 Months Ended | |||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | Dec. 31, 2016 | |
Income Tax Disclosure [Abstract] | |||||
Provision for income taxes | $ 27,000 | $ 25,000 | $ 94,000 | $ 71,000 | |
Deferred tax benefit | 0 | ||||
Unrecognized income tax benefits, interest and penalties accrued | $ 0 | $ 0 | $ 0 |
Commitments and Contingencies -
Commitments and Contingencies - Narrative (Details) - USD ($) $ in Thousands | 3 Months Ended | 9 Months Ended | ||
Sep. 30, 2017 | Sep. 30, 2016 | Sep. 30, 2017 | Sep. 30, 2016 | |
Commitments | ||||
Future minimum rental payments under lease | $ 4,293 | $ 4,293 | ||
Rent expense charged to operations | 400 | $ 400 | 1,100 | $ 900 |
Bridgewater, NJ Facility | ||||
Commitments | ||||
Future minimum rental payments under lease | 2,200 | 2,200 | ||
Future minimum rental payments for additional laboratory space | $ 2,000 | $ 2,000 |
Commitments and Contingencies37
Commitments and Contingencies - Minimum Rental Payments (Details) $ in Thousands | Sep. 30, 2017USD ($) |
Future minimum rental payments under operating leases | |
2017 (remaining) | $ 377 |
2,018 | 1,520 |
2,019 | 1,421 |
2,020 | 477 |
2,021 | 498 |
2,022 | 0 |
Total | $ 4,293 |