Document and Entity Information
Document and Entity Information - shares | 3 Months Ended | |
Mar. 31, 2017 | Apr. 28, 2017 | |
Document And Entity Information [Abstract] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Mar. 31, 2017 | |
Document Fiscal Year Focus | 2,017 | |
Document Fiscal Period Focus | Q1 | |
Trading Symbol | AIMT | |
Entity Registrant Name | AIMMUNE THERAPEUTICS, INC. | |
Entity Central Index Key | 1,631,650 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | 50,342,674 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 78,714 | $ 124,010 |
Short-term investments | 167,533 | 124,921 |
Prepaid expenses and other current assets | 2,625 | 2,749 |
Total current assets | 248,872 | 251,680 |
Long-term investments | 13,065 | 33,602 |
Property and equipment, net | 11,147 | 10,391 |
Prepaid expenses and other assets | 3,205 | 3,116 |
Total assets | 276,289 | 298,789 |
Current liabilities: | ||
Accounts payable | 1,676 | 1,427 |
Accrued liabilities | 8,440 | 9,921 |
Other current liabilities | 107 | 102 |
Total current liabilities | 10,223 | 11,450 |
Other liabilities | 1,348 | 1,367 |
Total liabilities | 11,571 | 12,817 |
Commitments and contingencies (Note 5) | ||
Stockholders’ equity: | ||
Common stock, par value $0.0001 per share—290,000 shares authorized as of March 31, 2017, and December 31, 2016; 50,316 and 50,204 shares issued and outstanding as of March 31, 2017, and December 31, 2016, respectively (including 156 and 200 shares subject to repurchase, legally issued and outstanding as of March 31, 2017, and December 31, 2016, respectively) | 5 | 5 |
Additional paid-in capital | 424,862 | 420,151 |
Accumulated other comprehensive loss | (122) | (27) |
Accumulated deficit | (160,027) | (134,157) |
Total stockholders’ equity | 264,718 | 285,972 |
Total liabilities and stockholders’ equity | $ 276,289 | $ 298,789 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Mar. 31, 2017 | Dec. 31, 2016 |
Common stock, par value | $ 0.0001 | $ 0.0001 |
Common stock, shares authorized | 290,000,000 | 290,000,000 |
Common stock, shares issued | 50,316,000 | 50,204,000 |
Common stock, shares outstanding | 50,316,000 | 50,204,000 |
Common Stock Subject to Repurchase | ||
Common stock, shares issued | 156,000 | 200,000 |
Common stock, shares outstanding | 156,000 | 200,000 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF COMPREHENSIVE LOSS (Unaudited) - USD ($) shares in Thousands, $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Operating expenses | ||
Research and development | $ 17,417 | $ 9,976 |
General and administrative | 8,924 | 5,723 |
Total operating expenses | 26,341 | 15,699 |
Loss from operations | (26,341) | (15,699) |
Interest income, net | 471 | 176 |
Net loss | (25,870) | (15,523) |
Other comprehensive loss, net of tax: | ||
Unrealized gains (losses) on investments | (95) | 94 |
Comprehensive loss | $ (25,965) | $ (15,429) |
Net loss per common share, basic and diluted | $ (0.52) | $ (0.37) |
Weighted average shares used in computing net loss per common share, basic and diluted | 50,069 | 41,694 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (Unaudited) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Cash flows from operating activities: | ||
Net loss | $ (25,870) | $ (15,523) |
Adjustments to reconcile net loss to net cash used in operating activities | ||
Depreciation expense | 144 | 125 |
Stock-based compensation expense | 3,593 | 2,531 |
Investment premium amortization, net | 240 | 291 |
Changes in operating assets and liabilities: | ||
Prepaid expenses | 125 | 611 |
Other assets | (90) | (32) |
Accounts payable | 249 | (78) |
Accrued liabilities | (1,481) | 277 |
Other liabilities | (14) | 215 |
Net cash used in operating activities | (23,104) | (11,583) |
Cash flows from investing activities: | ||
Purchase of property and equipment | (900) | (1,116) |
Purchase of investments | (55,419) | (63,064) |
Maturities of investments | 33,009 | 64,086 |
Net cash used in investing activities | (23,310) | (94) |
Cash flows from financing activities: | ||
Net cash proceeds from exercise of stock options, including early exercise | 1,118 | 45 |
Net cash provided by financing activities | 1,118 | 45 |
Net decrease in cash and cash equivalents | (45,296) | (11,632) |
Cash and cash equivalents at the beginning of the period | 124,010 | 76,677 |
Cash and cash equivalents at the end of the period | $ 78,714 | $ 65,045 |
Formation and Business of the C
Formation and Business of the Company | 3 Months Ended |
Mar. 31, 2017 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |
Formation and Business of the Company | 1. Formation and Business of the Company Aimmune Therapeutics, Inc., or the Company, is a clinical-stage biopharmaceutical company advancing a new therapeutic approach, including the development of proprietary product candidates, for the treatment of peanut and other food allergies. Our therapeutic approach, which we refer to as Characterized Oral Desensitization Immunotherapy, or CODIT TM Since inception, we have incurred net losses and negative cash flows from operations. During the quarter ended March 31, 2017, we incurred a net loss of $25.9 million and used $23.1 million of cash in operations. As of March 31, 2017, we had an accumulated deficit of $160.0 million, and we do not expect to experience positive cash flows in the near future. As of March 31, 2017, we had cash, cash equivalents and investments of $259.3 million. We believe that our existing capital resources will be sufficient to fund our planned operations for at least the next 12 months and through regulatory submissions for AR101, our lead CODIT TM |
Summary of Significant Accounti
Summary of Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2017 | |
Accounting Policies [Abstract] | |
Summary of Significant Accounting Policies | 2. Summary of Significant Accounting Policies Basis of Preparation The accompanying condensed consolidated financial statements have been prepared in accordance with Generally Accepted Accounting Principles, or GAAP, in the United States and applicable rules and regulations of the Securities and Exchange Commission, or SEC, regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted, and accordingly the balance sheet as of December 31, 2015, has been derived from audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. These condensed consolidated financial statements have been prepared on the same basis as our annual financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for a fair presentation of our financial information. The results of operations for the quarter March 31, 2017, are not necessarily indicative of the results to be expected for the year ending December 31, 2017, or for any other interim period or for any other future year. We operate in one reportable segment. The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2016, included in our Annual Report on Form 10-K filed with the SEC. Basis of Consolidation The accompanying condensed consolidated financial statements include the accounts of our wholly-owned subsidiaries. All significant intercompany transactions have been eliminated. Use of Estimates The preparation of the accompanying condensed consolidated financial statements in accordance with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of costs and expenses during the reporting period. We base our estimates and assumptions on historical experience when available and on various factors that we believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Our actual results could differ from these estimates under different assumptions or conditions. Significant Accounting Policies There have been no significant changes to the accounting policies during the quarter ended March 31, 2017, as compared to the significant accounting policies described in Note 2 of the “Notes to Financial Statements” in our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2016. Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2016-02, Leases (Topic 842) . The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of their classification. Leases with a term of 12 months or less will be accounted for similar to existing guidance for operating leases. The standard is effective for interim and annual periods beginning after December 15, 2018, with early adoption permitted. The new standard is expected to impact our consolidated financial statements as we have certain operating lease arrangements for which we are the lessee. We are currently evaluating the impact the adoption of this new standard will have on our consolidated financial statements. In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting , which simplifies several aspects of accounting for share-based payment transactions including the income tax consequences, classification of awards as either equity or liabilities, classification on the statement of cash flows and accounting for forfeitures. Upon our adoption of the new standard for fiscal year 2017, all excess tax benefits and tax deficiencies are recognized as income tax expense or benefit in the income statement. The tax effects of exercised or vested awards are treated as discrete items in the reporting period in which they occur. We recognize excess tax benefits regardless of whether the benefit reduces taxes payable in the current period. We applied the modified retrospective approach upon adoption, and prior periods have not been adjusted. As a result, we have established a net operating loss deferred tax asset of $1.2 million to account for prior period excess tax benefits through retained earnings; however, an offsetting valuation allowance of $1.2 million has also been established through retained earnings because it is not more likely than not that the deferred tax asset will be realized due to historical and expected future losses, such that there is no impact on our condensed consolidated financial statements. As permitted under this ASU, we have elected to continue to estimate forfeitures expected to occur to determine the amount of stock-based compensation expense to be recognized in each period. |
Available-for-Sale Securities a
Available-for-Sale Securities and Fair Value Measurements | 3 Months Ended |
Mar. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Available-for-Sale Securities and Fair Value Measurements | 3. Available-for-Sale Securities and Fair Value Measurements We define fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an Our valuation techniques are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect our market assumptions. We classify these inputs into the following hierarchy: • Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; • Level 2—Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and • Level 3—Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data. The following table sets forth our financial instrumen ts that were measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands): March 31, 2017 Level 1 Level 2 Level 3 Total Cash and cash equivalents: Cash and money market funds $ 50,771 $ — $ — $ 50,771 Corporate securities — 3,250 — 3,250 Commercial paper — 24,693 — 24,693 Total cash and cash equivalents $ 50,771 $ 27,943 $ — $ 78,714 Investments: Agency securities $ — $ 36,520 $ — $ 36,520 Corporate securities — 58,580 — 58,580 Commercial paper — 16,359 — 16,359 U.S. government securities — 69,139 — 69,139 Total investments $ — $ 180,598 $ — $ 180,598 December 31, 2016 Level 1 Level 2 Level 3 Total Cash and cash equivalents: Cash and money market funds $ 107,977 $ — $ — $ 107,977 Commercial paper — 16,033 — 16,033 Total cash and cash equivalents $ 107,977 $ 16,033 $ — $ 124,010 Investments Agency securities $ — $ 45,571 $ — $ 45,571 Corporate securities — 22,031 — 22,031 Commercial paper — 8,669 — 8,669 U.S. government securities — 82,252 — 82,252 Total investments $ — $ 158,523 $ — $ 158,523 Our valuation techniques used to measure the fair value of money market funds were derived from quoted prices in active markets for identical assets. The valuation techniques used to measure the fair value of investments, all of which have counterparties with high credit ratings, were valued based on quoted market prices or model-driven valuations using significant inputs derived from or corroborated by observable market data. Investments are carried at fair value. During the quarter ended March 31, 2017, there were no transfers between Level 1 and Level 2 of the fair value hierarchy. Available-for-sale investments are carried at fair value and are included in the tables above. The aggregate market value, cost basis, and gross unrealized gains and losses of available-for-sale investments by security type, classified in cash equivalents and investments, as of March 31, 2017 and December 31, 2016, are as follows March 31, 2017 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Total Fair Value Agency securities $ 36,559 $ — $ (39 ) $ 36,520 Corporate securities 61,879 3 (52 ) 61,830 Commercial paper 41,052 — — 41,052 U.S. government securities 69,173 — (34 ) 69,139 Total available-for-sale investments $ 208,663 $ 3 $ (125 ) $ 208,541 December 31, 2016 Amortized Cost Gross unrealized gains Gross unrealized losses Total fair value Agency securities $ 45,591 $ 5 $ (25 ) $ 45,571 Corporate securities 22,050 2 (21 ) 22,031 Commercial paper 24,702 — — 24,702 U.S. government securities 82,240 15 (3 ) 82,252 Total available-for-sale investments $ 174,583 $ 22 $ (49 ) $ 174,556 At March 31, 2017, all of the available-for-sale securities have contractual maturities within two years. We periodically review our available-for-sale investments for other-than-temporary impairment loss. We consider factors such as the duration, severity and the reason for the decline in value, the potential recovery period and our intent to sell. For debt securities, we also consider whether (i) it is more likely than not that we will be required to sell the debt securities before recovery of their amortized cost basis, and (ii) the amortized cost basis cannot be recovered as a result of credit losses. During the quarter ended March 31, 2017, we did not recognize any other-than-temporary impairment loss. All marketable securities with unrealized losses have been in a loss position for less than twelve months. |
Balance Sheet Components
Balance Sheet Components | 3 Months Ended |
Mar. 31, 2017 | |
Balance Sheet Related Disclosures [Abstract] | |
Balance Sheet Components | 4. Balance Sheet Components Property and Equipment, Net Property and equipment, net consists of the following (in thousands): March 31, 2017 December 31, 2016 Furniture and equipment $ 777 $ 776 Computer equipment 908 850 Manufacturing equipment 703 703 Construction in progress 9,590 8,749 Property and equipment, gross 11,978 11,078 Less: accumulated depreciation (831 ) (687 ) Property and equipment, net $ 11,147 $ 10,391 Accrued Liabilities Accrued liabilities consisted of the following (in thousands): March 31, 2017 December 31, 2016 Compensation and benefits $ 1,706 $ 3,195 Research and development 5,204 5,154 Professional and consulting 1,011 967 Other 519 605 Total accrued liabilities $ 8,440 $ 9,921 |
Commitments and Contingencies
Commitments and Contingencies | 3 Months Ended |
Mar. 31, 2017 | |
Commitments And Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | 5. Commitments and Contingencies Indemnifications We indemnify each of our officers and directors for certain events or occurrences, subject to certain limits, while the officer or director is or was serving at the Company’s request in such capacity, as permitted under Delaware law and in accordance with its certificate of incorporation and bylaws. The term of the indemnification period lasts as long as an officer or a director may be subject to any proceeding arising out of acts or omissions of such officer or director in such capacity. The maximum amount of potential future indemnification is unlimited; however, we currently hold director and officer liability insurance. This insurance allows the transfer of risk associated with our exposure and may enable us to recover a portion of any future amounts paid. We believe that the fair value of these indemnification obligations is minimal. Accordingly, we have not recognized any liabilities relating to these obligations for any period. Legal We are currently not a party to any material legal proceedings. During the normal course of business, we may be a party to legal claims that may not be covered by insurance. We do not believe that any such claims would have a material impact on our consolidated financial statements. |
Stock-based Compensation
Stock-based Compensation | 3 Months Ended |
Mar. 31, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Stock-Based Compensation | 6. Stock-Based Compensation Equity Incentive Plan In January 2013, we adopted our Stock Plan (the “2013 Plan”) and in July 2015, we adopted a new Stock Plan (the “2015 Plan”). Upon consummation of our IPO, the 2013 Plan was terminated and no further shares are reserved for issuance under the 2013 Plan. As of March 31, 2017, there were 5.0 million shares reserved for future issuance under our 2015 Plan. As of March 31, 2017, there were 6.9 million shares subject to outstanding options under our Plans. The 2013 Plan allowed employees to exercise stock options in exchange for cash before the requisite service was provided (e.g., before the award is vested under its original terms); however, such arrangements permit us to subsequently repurchase such shares at the exercise price if the vesting conditions are not satisfied. Such an exercise is not substantive for accounting purposes. Therefore, the payment received by us for the exercise price is recognized as an early exercise liability on the consolidated balance sheets and will be transferred to common stock and additional paid-in capital as such shares vest. As of March 31, 2017, and Option activity under the 2015 Plan and 2013 Plan is set forth below: Options Outstanding Number Options and Unvested Shares Weighted- Average Exercise Price Weighted Average Remaining Contractual Life (in years) Aggregate Intrinsic Value (in thousands) Balance, December 31, 2016 5,628,907 $ 9.50 9.02 $ 61,617 Options granted 1,395,700 $ 19.53 Options exercised and shares vested (150,254 ) $ 10.22 Options cancelled (18,642 ) $ 16.67 Balance, March 31, 2017 6,855,711 $ 11.57 8.76 $ 69,645 Options vested and expected to vest as of March 31, 2017 6,511,792 $ 11.39 8.07 $ 67,304 Options exercisable as of March 31, 2017 3,459,872 $ 5.78 8.72 $ 55,201 The aggregate intrinsic values of options outstanding, exercisable, and vested and expected to vest were calculated as the difference between the exercise price of the options and the market price for shares of our common stock as of March 31, 2017. The 2013 Plan provided for early exercise, therefore, all our outstanding stock options issued under that plan are exercisable. As of March 31, 2017 and 2016, there was $43.7 million and $34.4 million, respectively, of unrecognized stock-based compensation expense related to stock options, which is expected to be recognized over the weighted-average remaining vesting period of 2.9 years and 3.3 years, respectively. Restricted stock unit, or RSU, activity under the 2015 Plan is set forth below: Shares Weighted Average Grant Date Fair Value Unvested Balance, December 31, 2016 17,000 $ 14.01 Awarded — — Released (5,000 ) 14.30 Forfeited — — Unvested Balance, March 31, 2017 12,000 $ 13.89 RSUs are measured based on the fair market value of the underlying stock on the date of grant and recognized as expense on a straight-line basis over the employee’s requisite service period (generally the vesting period). As of March 31, 2017, unrecognized compensation expense related to unvested RSUs was immaterial and was expected to be recognized over the remaining vesting period of less than one month. Valuation Assumptions The weighted-average assumptions used to estimate the fair value of stock options using the Black-Scholes option valuation model and the resulting weighted average fair value of stock options granted were as follows : Quarter Ended March 31, 2017 2016 Expected term (in years) 6.1 6.1 Expected volatility 73.5 % 74.3 % Risk free interest rate 2.1 % 1.9 % Dividend yield — % — % Weighted average estimated fair value $ 12.82 $ 10.93 Stock-Based Compensation Expense Stock-based compensation expense, net of estimated forfeitures, reflected in the statements of operations and comprehensive loss is as follows (in thousands): Quarter Ended March 31, 2017 2016 Research and development $ 986 $ 945 General and administrative 2,607 1,586 Total stock-based compensation expense $ 3,593 $ 2,531 |
Net Loss per Share
Net Loss per Share | 3 Months Ended |
Mar. 31, 2017 | |
Earnings Per Share [Abstract] | |
Net Loss per Share | 7. Net Loss per Share Basic net loss per share is calculated based on the weighted-average number of common shares outstanding during the periods presented. For periods in which we have generated a net loss, basic and diluted net loss per share are the same due to the requirement to exclude potentially dilutive securities, consisting of common shares underlying outstanding stock options and restricted stock units, which would have an anti-dilutive effect on net loss per share. The following common stock equivalents were excluded from the computation of diluted net loss per share for the periods presented because their inclusion would have been antidilutive: Quarter Ended March 31, 2017 2016 Stock options 6,855,711 6,029,765 Restricted stock units 12,000 5,000 |
Summary of Significant Accoun13
Summary of Significant Accounting Policies (Policies) | 3 Months Ended |
Mar. 31, 2017 | |
Accounting Policies [Abstract] | |
Basis of Preparation | Basis of Preparation The accompanying condensed consolidated financial statements have been prepared in accordance with Generally Accepted Accounting Principles, or GAAP, in the United States and applicable rules and regulations of the Securities and Exchange Commission, or SEC, regarding interim financial reporting. As permitted under those rules, certain footnotes or other financial information that are normally required by U.S. GAAP have been condensed or omitted, and accordingly the balance sheet as of December 31, 2015, has been derived from audited consolidated financial statements at that date but does not include all of the information required by U.S. GAAP for complete financial statements. These condensed consolidated financial statements have been prepared on the same basis as our annual financial statements and, in the opinion of management, reflect all adjustments (consisting only of normal recurring adjustments) that are necessary for a fair presentation of our financial information. The results of operations for the quarter March 31, 2017, are not necessarily indicative of the results to be expected for the year ending December 31, 2017, or for any other interim period or for any other future year. We operate in one reportable segment. The accompanying condensed consolidated financial statements and related financial information should be read in conjunction with the audited consolidated financial statements and the related notes thereto for the year ended December 31, 2016, included in our Annual Report on Form 10-K filed with the SEC. |
Basis of Consolidation | Basis of Consolidation The accompanying condensed consolidated financial statements include the accounts of our wholly-owned subsidiaries. All significant intercompany transactions have been eliminated. |
Use of Estimates | Use of Estimates The preparation of the accompanying condensed consolidated financial statements in accordance with U.S. GAAP requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the condensed consolidated financial statements, and the reported amounts of costs and expenses during the reporting period. We base our estimates and assumptions on historical experience when available and on various factors that we believe to be reasonable under the circumstances. We evaluate our estimates and assumptions on an ongoing basis. Our actual results could differ from these estimates under different assumptions or conditions. |
Significant Accounting Policies | Significant Accounting Policies There have been no significant changes to the accounting policies during the quarter ended March 31, 2017, as compared to the significant accounting policies described in Note 2 of the “Notes to Financial Statements” in our audited consolidated financial statements included in our Annual Report on Form 10-K for the year ended December 31, 2016. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In February 2016, the Financial Accounting Standards Board, or FASB, issued Accounting Standards Update, or ASU, No. 2016-02, Leases (Topic 842) . The new standard requires lessees to apply a dual approach, classifying leases as either finance or operating leases based on the principle of whether or not the lease is effectively a financed purchase by the lessee. This classification will determine whether lease expense is recognized based on an effective interest method or on a straight-line basis over the term of the lease. A lessee is also required to record a right-of-use asset and a lease liability for all leases with a term of greater than 12 months regardless of their classification. Leases with a term of 12 months or less will be accounted for similar to existing guidance for operating leases. The standard is effective for interim and annual periods beginning after December 15, 2018, with early adoption permitted. The new standard is expected to impact our consolidated financial statements as we have certain operating lease arrangements for which we are the lessee. We are currently evaluating the impact the adoption of this new standard will have on our consolidated financial statements. In March 2016, the FASB issued ASU No. 2016-09, Compensation—Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting , which simplifies several aspects of accounting for share-based payment transactions including the income tax consequences, classification of awards as either equity or liabilities, classification on the statement of cash flows and accounting for forfeitures. Upon our adoption of the new standard for fiscal year 2017, all excess tax benefits and tax deficiencies are recognized as income tax expense or benefit in the income statement. The tax effects of exercised or vested awards are treated as discrete items in the reporting period in which they occur. We recognize excess tax benefits regardless of whether the benefit reduces taxes payable in the current period. We applied the modified retrospective approach upon adoption, and prior periods have not been adjusted. As a result, we have established a net operating loss deferred tax asset of $1.2 million to account for prior period excess tax benefits through retained earnings; however, an offsetting valuation allowance of $1.2 million has also been established through retained earnings because it is not more likely than not that the deferred tax asset will be realized due to historical and expected future losses, such that there is no impact on our condensed consolidated financial statements. As permitted under this ASU, we have elected to continue to estimate forfeitures expected to occur to determine the amount of stock-based compensation expense to be recognized in each period. |
Fair Value Measurements | We define fair value as the exchange price that would be received for an asset or paid to transfer a liability (an exit price) in the principal or most advantageous market for the asset or liability in an Our valuation techniques are based on observable and unobservable inputs. Observable inputs reflect readily obtainable data from independent sources, while unobservable inputs reflect our market assumptions. We classify these inputs into the following hierarchy: • Level 1—Inputs are unadjusted, quoted prices in active markets for identical assets or liabilities at the measurement date; • Level 2—Inputs are observable, unadjusted quoted prices in active markets for similar assets or liabilities, unadjusted quoted prices for identical or similar assets or liabilities in markets that are not active, or other inputs that are observable or can be corroborated by observable market data for substantially the full term of the related assets or liabilities; and • Level 3—Unobservable inputs that are significant to the measurement of the fair value of the assets or liabilities that are supported by little or no market data. |
Available-for-Sale Securities14
Available-for-Sale Securities and Fair Value Measurements (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Fair Value Disclosures [Abstract] | |
Summary of Financial Instruments Measured at Fair Value on a Recurring Basis | The following table sets forth our financial instrumen ts that were measured at fair value on a recurring basis by level within the fair value hierarchy (in thousands): March 31, 2017 Level 1 Level 2 Level 3 Total Cash and cash equivalents: Cash and money market funds $ 50,771 $ — $ — $ 50,771 Corporate securities — 3,250 — 3,250 Commercial paper — 24,693 — 24,693 Total cash and cash equivalents $ 50,771 $ 27,943 $ — $ 78,714 Investments: Agency securities $ — $ 36,520 $ — $ 36,520 Corporate securities — 58,580 — 58,580 Commercial paper — 16,359 — 16,359 U.S. government securities — 69,139 — 69,139 Total investments $ — $ 180,598 $ — $ 180,598 December 31, 2016 Level 1 Level 2 Level 3 Total Cash and cash equivalents: Cash and money market funds $ 107,977 $ — $ — $ 107,977 Commercial paper — 16,033 — 16,033 Total cash and cash equivalents $ 107,977 $ 16,033 $ — $ 124,010 Investments Agency securities $ — $ 45,571 $ — $ 45,571 Corporate securities — 22,031 — 22,031 Commercial paper — 8,669 — 8,669 U.S. government securities — 82,252 — 82,252 Total investments $ — $ 158,523 $ — $ 158,523 |
Summary of Aggregate Market Value, Cost Basis and Gross Unrealized Gains and Losses of Available-for-Sale Investments by Security Type | The aggregate market value, cost basis, and gross unrealized gains and losses of available-for-sale investments by security type, classified in cash equivalents and investments, as of March 31, 2017 and December 31, 2016, are as follows (in thousands): March 31, 2017 Amortized Cost Gross Unrealized Gains Gross Unrealized Losses Total Fair Value Agency securities $ 36,559 $ — $ (39 ) $ 36,520 Corporate securities 61,879 3 (52 ) 61,830 Commercial paper 41,052 — — 41,052 U.S. government securities 69,173 — (34 ) 69,139 Total available-for-sale investments $ 208,663 $ 3 $ (125 ) $ 208,541 December 31, 2016 Amortized Cost Gross unrealized gains Gross unrealized losses Total fair value Agency securities $ 45,591 $ 5 $ (25 ) $ 45,571 Corporate securities 22,050 2 (21 ) 22,031 Commercial paper 24,702 — — 24,702 U.S. government securities 82,240 15 (3 ) 82,252 Total available-for-sale investments $ 174,583 $ 22 $ (49 ) $ 174,556 |
Balance Sheet Components (Table
Balance Sheet Components (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Balance Sheet Related Disclosures [Abstract] | |
Summary of Property And Equipment, Net | Property and equipment, net consists of the following (in thousands): March 31, 2017 December 31, 2016 Furniture and equipment $ 777 $ 776 Computer equipment 908 850 Manufacturing equipment 703 703 Construction in progress 9,590 8,749 Property and equipment, gross 11,978 11,078 Less: accumulated depreciation (831 ) (687 ) Property and equipment, net $ 11,147 $ 10,391 |
Summary of Accrued Liabilities | Accrued liabilities consisted of the following (in thousands): March 31, 2017 December 31, 2016 Compensation and benefits $ 1,706 $ 3,195 Research and development 5,204 5,154 Professional and consulting 1,011 967 Other 519 605 Total accrued liabilities $ 8,440 $ 9,921 |
Stock-based Compensation (Table
Stock-based Compensation (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Disclosure Of Compensation Related Costs Sharebased Payments [Abstract] | |
Summary of Stock Option Activity | Option activity under the 2015 Plan and 2013 Plan is set forth below: Options Outstanding Number Options and Unvested Shares Weighted- Average Exercise Price Weighted Average Remaining Contractual Life (in years) Aggregate Intrinsic Value (in thousands) Balance, December 31, 2016 5,628,907 $ 9.50 9.02 $ 61,617 Options granted 1,395,700 $ 19.53 Options exercised and shares vested (150,254 ) $ 10.22 Options cancelled (18,642 ) $ 16.67 Balance, March 31, 2017 6,855,711 $ 11.57 8.76 $ 69,645 Options vested and expected to vest as of March 31, 2017 6,511,792 $ 11.39 8.07 $ 67,304 Options exercisable as of March 31, 2017 3,459,872 $ 5.78 8.72 $ 55,201 |
Restricted Stock Unit Activity | Restricted stock unit, or RSU, activity under the 2015 Plan is set forth below: Shares Weighted Average Grant Date Fair Value Unvested Balance, December 31, 2016 17,000 $ 14.01 Awarded — — Released (5,000 ) 14.30 Forfeited — — Unvested Balance, March 31, 2017 12,000 $ 13.89 |
Schedule of Weighted Average Assumptions to Fair Value of Stock Options | The weighted-average assumptions used to estimate the fair value of stock options using the Black-Scholes option valuation model and the resulting weighted average fair value of stock options granted were as follows : Quarter Ended March 31, 2017 2016 Expected term (in years) 6.1 6.1 Expected volatility 73.5 % 74.3 % Risk free interest rate 2.1 % 1.9 % Dividend yield — % — % Weighted average estimated fair value $ 12.82 $ 10.93 |
Summary of Stock-based Compensation Expense Net of Estimated Forfeitures | Stock-Based Compensation Expense Stock-based compensation expense, net of estimated forfeitures, reflected in the statements of operations and comprehensive loss is as follows (in thousands): Quarter Ended March 31, 2017 2016 Research and development $ 986 $ 945 General and administrative 2,607 1,586 Total stock-based compensation expense $ 3,593 $ 2,531 |
Net Loss per Share (Tables)
Net Loss per Share (Tables) | 3 Months Ended |
Mar. 31, 2017 | |
Earnings Per Share [Abstract] | |
Schedule of Antidilutive Securities Excluded from Computation of Diluted Net Loss per Share | The following common stock equivalents were excluded from the computation of diluted net loss per share for the periods presented because their inclusion would have been antidilutive: Quarter Ended March 31, 2017 2016 Stock options 6,855,711 6,029,765 Restricted stock units 12,000 5,000 |
Formation and Business of the18
Formation and Business of the Company - Additional Information (Details) - USD ($) $ in Thousands | 3 Months Ended | ||
Mar. 31, 2017 | Mar. 31, 2016 | Dec. 31, 2016 | |
Organization Consolidation And Presentation Of Financial Statements [Abstract] | |||
Net loss | $ 25,870 | $ 15,523 | |
Net cash used in operating activities | 23,104 | $ 11,583 | |
Accumulated deficit | 160,027 | $ 134,157 | |
Cash, cash equivalents and investments | $ 259,300 |
Summary of Significant Accoun19
Summary of Significant Accounting Policies - Additional Information (Details) $ in Millions | 3 Months Ended |
Mar. 31, 2017USD ($)Segment | |
Significant Accounting Policies [Line Items] | |
Number of reportable segments | Segment | 1 |
Deferred Tax Asset | Retained Earnings | ASU 2016-09 | |
Significant Accounting Policies [Line Items] | |
Cumulative effect adjustment to retained earnings | $ 1.2 |
Offsetting Valuation Allowance | Retained Earnings | ASU 2016-09 | |
Significant Accounting Policies [Line Items] | |
Cumulative effect adjustment to retained earnings | $ 1.2 |
Available-for-Sale Securities20
Available-for-Sale Securities and Fair Value Measurements - Summary of Financial Instruments Measured at Fair Value on a Recurring Basis (Details) - Fair Value Measurements Recurring - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Cash and cash equivalents | ||
Total cash and cash equivalents | $ 78,714 | $ 124,010 |
Investments: | ||
Total investments | 180,598 | 158,523 |
Commercial Paper | ||
Cash and cash equivalents | ||
Total cash and cash equivalents | 24,693 | 16,033 |
Investments: | ||
Total investments | 16,359 | 8,669 |
U.S. Government Securities | ||
Investments: | ||
Total investments | 69,139 | 82,252 |
Corporate Debt Securities | ||
Cash and cash equivalents | ||
Total cash and cash equivalents | 3,250 | |
Investments: | ||
Total investments | 58,580 | 22,031 |
Agency Securities | ||
Investments: | ||
Total investments | 36,520 | 45,571 |
Cash and money market funds | ||
Cash and cash equivalents | ||
Total cash and cash equivalents | 50,771 | 107,977 |
Level 1 | ||
Cash and cash equivalents | ||
Total cash and cash equivalents | 50,771 | 107,977 |
Level 1 | Cash and money market funds | ||
Cash and cash equivalents | ||
Total cash and cash equivalents | 50,771 | 107,977 |
Level 2 | ||
Cash and cash equivalents | ||
Total cash and cash equivalents | 27,943 | 16,033 |
Investments: | ||
Total investments | 180,598 | 158,523 |
Level 2 | Commercial Paper | ||
Cash and cash equivalents | ||
Total cash and cash equivalents | 24,693 | 16,033 |
Investments: | ||
Total investments | 16,359 | 8,669 |
Level 2 | U.S. Government Securities | ||
Investments: | ||
Total investments | 69,139 | 82,252 |
Level 2 | Corporate Debt Securities | ||
Cash and cash equivalents | ||
Total cash and cash equivalents | 3,250 | |
Investments: | ||
Total investments | 58,580 | 22,031 |
Level 2 | Agency Securities | ||
Investments: | ||
Total investments | $ 36,520 | $ 45,571 |
Available-for-Sale Securities21
Available-for-Sale Securities and Fair Value Measurements - Additional Information (Details) | 3 Months Ended |
Mar. 31, 2017USD ($) | |
Fair Value Disclosures [Abstract] | |
Fair value assets transfers between level 1 to level 2 | $ 0 |
Fair value assets transfers between level 2 to level 1 | $ 0 |
Available-for-sale securities, maturities period | 2 years |
Other than temporary impairment losses | $ 0 |
Marketable securities unrealized losses position maximum period | 12 months |
Available-for-Sale Securities22
Available-for-Sale Securities and Fair Value Measurements - Summary of Aggregate Market Value, Cost Basis, and Gross Unrealized Gains and Losses of Available for Sale Investments by Security Type (Details) - Available-for-sale Securities - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Amortized Cost | $ 208,663 | $ 174,583 |
Gross Unrealized Gains | 3 | 22 |
Gross Unrealized Losses | (125) | (49) |
Total Available-for-Sale Investments | 208,541 | 174,556 |
Commercial Paper | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Amortized Cost | 41,052 | 24,702 |
Total Available-for-Sale Investments | 41,052 | 24,702 |
U.S. Government Securities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Amortized Cost | 69,173 | 82,240 |
Gross Unrealized Gains | 15 | |
Gross Unrealized Losses | (34) | (3) |
Total Available-for-Sale Investments | 69,139 | 82,252 |
Corporate Debt Securities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Amortized Cost | 61,879 | 22,050 |
Gross Unrealized Gains | 3 | 2 |
Gross Unrealized Losses | (52) | (21) |
Total Available-for-Sale Investments | 61,830 | 22,031 |
Agency Securities | ||
Fair Value Balance Sheet Grouping Financial Statement Captions [Line Items] | ||
Amortized Cost | 36,559 | 45,591 |
Gross Unrealized Gains | 5 | |
Gross Unrealized Losses | (39) | (25) |
Total Available-for-Sale Investments | $ 36,520 | $ 45,571 |
Balance Sheet Components - Summ
Balance Sheet Components - Summary of Property and Equipment, Net (Details) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 11,978 | $ 11,078 |
Less: accumulated depreciation | (831) | (687) |
Property and equipment, net | 11,147 | 10,391 |
Furniture and Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 777 | 776 |
Computer Equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 908 | 850 |
Manufacturing equipment | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | 703 | 703 |
Construction in Progress | ||
Property Plant And Equipment [Line Items] | ||
Property and equipment, gross | $ 9,590 | $ 8,749 |
Balance Sheet Components - Su24
Balance Sheet Components - Summary of Accrued Liabilities (Details) - USD ($) $ in Thousands | Mar. 31, 2017 | Dec. 31, 2016 |
Accrued Liabilities Current [Abstract] | ||
Compensation and benefits | $ 1,706 | $ 3,195 |
Research and development | 5,204 | 5,154 |
Professional and consulting | 1,011 | 967 |
Other | 519 | 605 |
Total accrued liabilities | $ 8,440 | $ 9,921 |
Stock-Based Compensation - Addi
Stock-Based Compensation - Additional Information (Details) - USD ($) | 3 Months Ended | ||
Mar. 31, 2017 | Mar. 31, 2016 | Dec. 31, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Unvested shares outstanding | 6,855,711 | 5,628,907 | |
Stock Options | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Unrecognized employee stock-based compensation | $ 43,700,000 | $ 34,400,000 | |
Expected recognized over weighted-average remaining vesting period | 2 years 10 months 24 days | 3 years 3 months 18 days | |
2013 Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Common stock, shares reserved for issuance | 0 | ||
Unvested shares outstanding | 155,573 | 199,538 | |
Unvested shares issued | 155,573 | 199,538 | |
Exercise liability | $ 30,800 | ||
Exercise liability current | 29,100 | ||
Exercise liability non-current | $ 1,700 | ||
2015 Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Common stock, shares reserved for issuance | 5,000,000 | ||
2013 and 2015 Plan | |||
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |||
Unvested shares outstanding | 6,900,000 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity (Details) - USD ($) $ / shares in Units, $ in Thousands | 3 Months Ended | 12 Months Ended |
Mar. 31, 2017 | Dec. 31, 2016 | |
Number of Options and Unvested Shares | ||
Number of Options and Unvested Shares, Beginning Balance | 5,628,907 | |
Number of Options and Unvested Shares, Options granted | 1,395,700 | |
Number of Options and Unvested Shares, Options exercised and shares vested | (150,254) | |
Number of Options and Unvested Shares, Options cancelled | (18,642) | |
Number of Options and Unvested Shares, Ending Balance | 6,855,711 | 5,628,907 |
Number of Options and Unvested Shares, Options vested and expected to vest as of March 31, 2017 | 6,511,792 | |
Number of Options and Unvested Shares, Options exercisable as of March 31, 2017 | 3,459,872 | |
Weighted-Average Exercise Price | ||
Weighted-Average Exercise Price, Beginning Balance | $ 9.50 | |
Weighted-Average Exercise Price, Options granted | 19.53 | |
Weighted-Average Exercise Price, Options exercised and shares vested | 10.22 | |
Weighted-Average Exercise Price, Options cancelled | 16.67 | |
Weighted-Average Exercise Price, Ending Balance | 11.57 | $ 9.50 |
Weighted-Average Exercise Price, Options vested and expected to vest as of March 31,2017 | 11.39 | |
Weighted-Average Exercise Price, Options exercisable as of March 31, 2017 | $ 5.78 | |
Weighted Average Remaining Contractual Life (in years) | ||
Weighted Average Remaining Contractual Life (in years), Balance | 8 years 9 months 4 days | 9 years 7 days |
Weighted Average Remaining Contractual Life, Options vested and expected to vest as of March 31, 2017 | 8 years 26 days | |
Weighted Average Remaining Contractual Life, Options exercisable as of March 31, 2017 | 8 years 8 months 19 days | |
Aggregate Intrinsic Value, Balance | $ 69,645 | $ 61,617 |
Aggregate Intrinsic Value, Options vested and expected to vest as of March 31, 2017 | 67,304 | |
Aggregate Intrinsic Value, Options exercisable as of March 31, 2017 | $ 55,201 |
Stock-Based Compensation - Rest
Stock-Based Compensation - Restricted Stock Unit Activity (Details) - 2015 Plan - Restricted Stock Units (RSUs) [Member] | 3 Months Ended |
Mar. 31, 2017$ / sharesshares | |
Share Based Compensation Arrangement By Share Based Payment Award [Line Items] | |
Unvested Shares, Beginning Balance | shares | 17,000 |
Shares, Released | shares | (5,000) |
Unvested Shares, Ending Balance | shares | 12,000 |
Weighted Average Grant Date Fair Value, Beginning Balance | $ / shares | $ 14.01 |
Weighted Average Grant Date Fair Value, Released | $ / shares | 14.30 |
Weighted Average Grant Date Fair Value, Ending Balance | $ / shares | $ 13.89 |
Stock-Based Compensation - Sche
Stock-Based Compensation - Schedule of Weighted Average Assumptions to Fair Value of Stock Options (Details) - $ / shares | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Share Based Compensation Arrangement By Share Based Payment Award Fair Value Assumptions And Methodology [Abstract] | ||
Expected term (in years) | 6 years 1 month 6 days | 6 years 1 month 6 days |
Expected volatility | 73.50% | 74.30% |
Risk free interest rate | 2.10% | 1.90% |
Weighted average estimated fair value | $ 12.82 | $ 10.93 |
Stock-Based Compensation - Su29
Stock-Based Compensation - Summary of Stock-based Compensation Expense Net of Estimated Forfeitures (Details) - USD ($) $ in Thousands | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 3,593 | $ 2,531 |
Research and Development | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | 986 | 945 |
General and Administrative | ||
Employee Service Share Based Compensation Allocation Of Recognized Period Costs [Line Items] | ||
Stock-based compensation expense | $ 2,607 | $ 1,586 |
Net Loss per Share - Schedule o
Net Loss per Share - Schedule of Antidilutive Securities Excluded from Computation of Diluted Net Loss per Share (Details) - shares | 3 Months Ended | |
Mar. 31, 2017 | Mar. 31, 2016 | |
Stock Options | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted net loss per share | 6,855,711 | 6,029,765 |
Restricted Stock Units | ||
Antidilutive Securities Excluded From Computation Of Earnings Per Share [Line Items] | ||
Antidilutive securities excluded from computation of diluted net loss per share | 12,000 | 5,000 |