Document and Entity Information
Document and Entity Information | 6 Months Ended | |
Jun. 30, 2016segment | Aug. 04, 2016shares | |
Document Information [Line Items] | ||
Number of operating segments | segment | 1 | |
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2016 | |
Document Fiscal Year Focus | 2,016 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | OMER | |
Entity Registrant Name | OMEROS CORP | |
Entity Central Index Key | 1,285,819 | |
Current Fiscal Year End Date | --12-31 | |
Entity Filer Category | Accelerated Filer | |
Entity Common Stock, Shares Outstanding | shares | 39,293,131 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Current assets: | ||
Cash and cash equivalents | $ 4,589 | $ 1,365 |
Short-term investments | 16,648 | 26,898 |
Receivables | 8,806 | 6,517 |
Inventory | 1,780 | 472 |
Prepaid expense | 2,282 | 1,894 |
Total current assets | 34,105 | 37,146 |
Property and equipment, net | 1,251 | 951 |
Restricted cash and investments | 10,679 | 10,679 |
Other assets | 73 | 219 |
Total assets | 46,108 | 48,995 |
Current liabilities: | ||
Accounts payable | 5,420 | 6,428 |
Accrued expenses | 10,452 | 9,752 |
Current portion of notes payable | 193 | 73 |
Total current liabilities | 16,065 | 16,253 |
Notes payable, net | 69,833 | 49,769 |
Deferred rent | 9,205 | 9,207 |
Commitments and contingencies (Note 8) | ||
Shareholders’ deficit: | ||
Preferred stock, par value $0.01 per share, 20,000,000 shares authorized and none issued and outstanding at June 30, 2016 and December 31, 2015 | 0 | |
Common stock, par value $0.01 per share, 150,000,000 shares authorized at June 30, 2016 and December 31, 2015; 39,277,231 and 38,040,891 issued and outstanding at June 30, 2016 and December 31, 2015, respectively | 393 | 380 |
Additional paid-in capital | 386,905 | 376,528 |
Accumulated deficit | (436,293) | (403,142) |
Total shareholders’ deficit | (48,995) | (26,234) |
Total liabilities and shareholders’ deficit | $ 46,108 | $ 48,995 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2016 | Dec. 31, 2015 |
Preferred stock, par value (USD per share) | $ 0.01 | $ 0.01 |
Preferred stock, authorized shares | 20,000,000 | 20,000,000 |
Preferred stock, Issued shares | 0 | 0 |
Preferred stock, outstanding shares | 0 | 0 |
Common stock, par value (USD per share) | $ 0.01 | $ 0.01 |
Common stock, authorized shares | 150,000,000 | 150,000,000 |
Common stock, Issued shares | 39,277,231 | 38,040,891 |
Common stock, outstanding shares | 39,277,231 | 38,040,891 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Product sales, net | $ 10,004 | $ 3,125 | $ 17,250 | $ 3,363 |
Grant revenue | 0 | 62 | 173 | 212 |
Revenue | 10,004 | 3,187 | 17,423 | 3,575 |
Costs and expenses | ||||
Cost of product sales | 327 | 365 | 654 | 376 |
Research and development | 10,231 | 10,900 | 25,665 | 20,218 |
Selling, general and administrative | 10,375 | 7,889 | 21,485 | 16,878 |
Total costs and expenses | 20,933 | 19,154 | 47,804 | 37,472 |
Loss from operations | (10,929) | (15,967) | (30,381) | (33,897) |
Interest expense | (1,857) | (937) | (3,232) | (1,894) |
Other income (expense), net | 174 | 224 | 462 | 442 |
Net loss | (12,612) | (16,680) | (33,151) | (35,349) |
Comprehensive loss | $ (12,612) | $ (16,680) | $ (33,151) | $ (35,349) |
Basic and diluted net loss per share (USD per share) | $ (0.32) | $ (0.44) | $ (0.86) | $ (0.95) |
Weighted-average shares used to compute basic and diluted net loss per share (shares) | 39,178,547 | 37,846,832 | 38,747,816 | 37,165,196 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Operating activities: | ||
Net loss | $ (33,151) | $ (35,349) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 122 | 107 |
Stock-based compensation expense | 7,031 | 4,898 |
Non-cash interest expense | 684 | 442 |
Changes in operating assets and liabilities: | ||
Receivables | (2,289) | (2,679) |
Inventory | (1,308) | (65) |
Prepaid expenses and other assets | (242) | (228) |
Accounts payable and accrued expenses | (268) | (1,229) |
Deferred rent | (2) | 82 |
Net cash used in operating activities | (29,423) | (34,021) |
Investing activities: | ||
Purchases and sales of property and equipment | (34) | (114) |
Purchases of investments | (20,625) | (79,403) |
Proceeds from the sale and maturities of investments | 30,875 | 37,050 |
Net cash provided by (used in) investing activities | 10,216 | (42,467) |
Financing activities: | ||
Proceeds from issuance of common stock and pre-funded warrants, net | 724 | 79,076 |
Proceeds from borrowings under notes payable, net | 19,864 | 0 |
Payments on notes payable | (34) | (2,342) |
Proceeds upon exercise of stock options and warrants | 1,877 | 1,961 |
Net cash provided by financing activities | 22,431 | 78,695 |
Net increase in cash and cash equivalents | 3,224 | 2,207 |
Cash and cash equivalents at beginning of period | 1,365 | 354 |
Cash and cash equivalents at end of period | 4,589 | 2,561 |
Supplemental cash flow information | ||
Cash paid for interest | 2,005 | 1,471 |
Issuance of warrants in connection with the Amendment to the Loan Agreement | 758 | 0 |
Property acquired under capital lease | 388 | 0 |
Prepaid expenses not yet paid | $ 1,035 | $ 68 |
Organization and Significant Ac
Organization and Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Organization and Significant Accounting Policies | Organization and Significant Accounting Policies Organization We are a biopharmaceutical company committed to discovering, developing and commercializing both small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, coagulopathies and disorders of the central nervous system. Our first drug product, OMIDRIA, is approved by the United States (U.S.) Food and Drug Administration (FDA) for use during cataract surgery or intraocular lens replacement. We broadly launched OMIDRIA in the U.S. in April 2015. Basis of Presentation Our condensed consolidated financial statements include the financial position and results of operations of Omeros Corporation (Omeros) and our wholly owned subsidiaries. All inter-company transactions have been eliminated and we have determined we operate in one segment. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. The information as of June 30, 2016 and for the three and six months ended June 30, 2016 and 2015 includes all adjustments, which include normal recurring adjustments, necessary to present fairly our interim financial information. The Condensed Consolidated Balance Sheet at December 31, 2015 has been derived from our audited financial statements but does not include all of the information and footnotes required by GAAP for audited annual financial information. The accompanying unaudited condensed consolidated financial statements and related notes thereto should be read in conjunction with the audited consolidated financial statements and related notes thereto that are included in our Annual Report on Form 10-K for the year ended December 31, 2015 , which was filed with the U.S. Securities and Exchange Commission (SEC) on March 15, 2016. Product Sales, Net We record revenue from OMIDRIA sales when the product is delivered to our wholesalers. Product sales are recorded net of estimated chargebacks and rebates, wholesaler distribution fees and estimated product returns. Accruals or allowances are established for these deductions when revenue is recognized, and actual amounts incurred are offset against the applicable accruals and allowances. We reflect each of these accruals or allowances as either a reduction in the related accounts receivable or as an accrued liability, depending on how the accrual or allowance is settled. Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant items subject to such estimates include revenue recognition, fair market value of investments, stock-based compensation expense and accruals for clinical trials and contingencies. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances; however, actual results could differ from these estimates. Liquidity and Capital Resources As of June 30, 2016 , we had $21.2 million in cash, cash equivalents and short-term investments. In addition, we have $ 10.0 million in restricted cash and investments that must be maintained in depository and investment accounts with East West Bank (EWB) pursuant to the Loan and Security Agreement (the Loan Agreement) entered into in December 2015 with Oxford Finance LLC (Oxford) and EWB as well as $679,000 to secure a letter of credit for the Omeros Building lease. As of June 30, 2016 we have $70.0 million in notes payable which contain financial covenants requiring us to achieve $70.0 million in OMIDRIA net revenues during calendar year 2016 and quarterly OMIDRIA net revenues of $25.0 million in 2017 and $30.0 million in 2018, or maintain 50% of the then-outstanding principal and other obligations under the Loan Agreement in restricted cash and certain eligible term investments. If the OMIDRIA net revenue covenant is met for any quarter of 2017 or 2018, any additional cash collateral requirement then in effect would be removed. If we are unable to meet these financial covenants for any period, obtain a waiver from the lenders or otherwise re-negotiate the Loan Agreement, the lenders could declare all obligations under the Loan Agreement to be due and payable and pursue all other remedies available to the lenders under the Loan Agreement. We expect to continue to incur losses until such time as OMIDRIA product sales, corporate partnerships and/or licensing revenues from products or programs are adequate to support our ongoing operating expenses and debt service, including maintenance of any restricted cash and investments, if required. We are unable to predict if or when this may occur, and until it does occur, we will need to continue to raise additional funds through public or private equity securities sales, including under our At Market Issuance Sales Agreement (the ATM Agreement) with JonesTrading Institutional Services LLC (JonesTrading) (see Note 9 for further detail), through the incurrence of additional debt, through corporate partnerships, through asset sales or through the pursuit of collaborations and licensing arrangements related to certain of our products or programs. These conditions raise a substantial doubt about our ability to continue as a going concern. If we are unable to become cash-flow positive or to raise additional capital as and when needed, or upon acceptable terms, such failure would have a significant negative impact on our financial condition. The accompanying unaudited condensed consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The accompanying unaudited condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from uncertainty related to our ability to continue as a going concern. Recently Adopted Accounting Pronouncements For the year ended December 31, 2015 we adopted and applied retrospectively Financial Accounting Standards Board (FASB) Accounting Standards Update, or ASU, No. 2015-03, related to simplifying the presentation of debt issuance costs. This standard requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction to the liability. Recent Accounting Pronouncements In August 2014, FASB issued ASU No. 2014-15 related to disclosure of an entity’s ability to continue as a going concern. This standard requires management to evaluate whether substantial doubt exists regarding the entity’s ability to continue as a going concern at each reporting period for a duration of one year after the date the financial statements are issued or available to be issued and to provide related footnote disclosures. This standard must be applied prospectively and is effective for interim and annual periods ending after December 15, 2016. We are monitoring for any conditions and events that could raise substantial doubt about our ability to continue as a going concern. The evaluation of the significance of those conditions and events and the related impact upon our disclosures, if applicable, will be disclosed in our annual financial statements for the year ended December 31, 2016. In February 2016, FASB issued ASU 2016-02 related to lease accounting. This standard requires lessees to recognize a right-of-use asset and a lease liability for most leases. This standard must be applied using a modified retrospective transition and is effective for all annual and interim periods beginning after December 15, 2018. Earlier adoption is permitted. We are evaluating how this new standard will impact the presentation of our financial statements and related disclosures. In March 2016, FASB issued ASU 2016-08 related to revenue recognition. This standard is an amendment to ASU 2014-09 relating to revenue from contracts with customers. This amendment clarifies an entity’s revenue recognition for a performance obligation based on principal versus agent considerations. This standard has the same effective date and transition requirements as ASU 2014-09, as amended, which requires that the guidance must be applied retroactively to each prior reporting period presented or retrospectively with the cumulative effect of applying the standard recognized in the period adopted. As amended, the standard is effective for interim and annual periods beginning after December 15, 2017 and cannot be adopted before the original effective date, which was for periods beginning after December 15, 2016. We are currently evaluating the impact that this standard may have on our financial statements once it is adopted. In March 2016, FASB issued ASU 2016-09 that changes the accounting for certain aspects of share-based payments to employees. The guidance requires the recognition of the income tax effects of awards in the income statement when the awards vest or are settled, thus eliminating additional paid in capital pools. The guidance also allows for the employer to repurchase more of an employee’s shares for tax withholding purposes without triggering liability accounting and for making a policy election to account for forfeitures as they occur rather than on an estimated basis. The guidance is effective for interim and annual periods beginning after December 15, 2016 with early adoption permitted. We are currently evaluating the impact that this standard may have on our financial statements once it is adopted and the timing of adoption. In April and May 2016, FASB issued ASU 2016-10 and ASU 2016-12, respectively. Both standards are amendments to ASU 2014-09 related to revenue from contracts with customers. ASU 2016-10 clarifies an entity’s revenue recognition when identifying performance obligations and licensing. ASU 2016-12 clarifies the objective of the collectibility criterion, one of the five steps of ASU 2014-09. This amendment also establishes practical expedients for sales-tax considerations and contract modifications. Both standards have the same effective date and transition requirements as ASU 2014-09, as amended. We are currently evaluating the impact that these standards may have on our financial statements once they are adopted. |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
Net Loss Per Share | Net Loss Per Share Basic net loss per share is calculated by dividing the net loss by the weighted-average number of common shares outstanding for the period. Diluted net loss per share is computed by dividing the net loss by the weighted-average number of common shares and dilutive common share equivalents outstanding for the period, determined using the treasury-stock method. The basic and diluted net loss per share amounts for the three and six months ended June 30, 2016 and 2015 were computed based on the shares of common stock outstanding during the respective periods. Potentially dilutive securities excluded from the diluted loss per share calculation are as follows: June 30, 2016 2015 Outstanding options to purchase common stock 9,501,818 8,427,501 Warrants and pre-funded warrants to purchase common stock 100,602 1,149,249 Total 9,602,420 9,576,750 |
Cash, Cash Equivalents and Inve
Cash, Cash Equivalents and Investments | 6 Months Ended |
Jun. 30, 2016 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents and Investments | Cash, Cash Equivalents and Investments As of June 30, 2016 and December 31, 2015 , all investments are classified as short-term and available-for-sale on the accompanying Condensed Consolidated Balance Sheets. We did not own any securities with unrealized loss positions as of June 30, 2016 or December 31, 2015 . Investment income, which is included as a component of other income (expense), consists of interest earned. |
Fair-Value Measurements
Fair-Value Measurements | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Fair-Value Measurements | Fair-Value Measurements On a recurring basis, we measure certain financial assets at fair value. Fair value is defined 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 orderly transaction between market participants on the measurement date. The accounting standard establishes a fair value hierarchy that requires an entity to maximize the use of observable inputs, where available. The following summarizes the three levels of inputs required: Level 1—Observable inputs for identical assets or liabilities, such as quoted prices in active markets; Level 2—Inputs other than quoted prices in active markets that are either directly or indirectly observable; and Level 3—Unobservable inputs in which little or no market data exists, therefore they are developed using estimates and assumptions developed by us, which reflect those that a market participant would use. Our fair value hierarchy for our financial assets and liabilities measured at fair value on a recurring basis are as follows: June 30, 2016 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted cash and investments $ 10,679 $ — $ — $ 10,679 Money-market funds classified as short-term investments 16,648 — — 16,648 Total $ 27,327 $ — $ — $ 27,327 December 31, 2015 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted cash and investments $ 10,679 $ — $ — $ 10,679 Money-market funds classified as short-term investments 26,898 — — 26,898 Total $ 37,577 $ — $ — $ 37,577 Cash held in demand deposit accounts of $4.6 million and $1.4 million is excluded from our fair-value hierarchy disclosure as of June 30, 2016 and December 31, 2015 , respectively. There were no unrealized gains and losses associated with our short-term investments as of June 30, 2016 or December 31, 2015 . The carrying amounts reported in the accompanying Condensed Consolidated Balance Sheets for receivables, accounts payable and other current monetary assets and liabilities approximate fair value because of the immediate or short-term maturity of these financial instruments. |
Inventory (Notes)
Inventory (Notes) | 6 Months Ended |
Jun. 30, 2016 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory The components of inventory are as follows: June 30, December 31, (In thousands) Raw materials $ 101 $ 93 Work-in-process 1,559 158 Finished goods 120 221 Total inventory $ 1,780 $ 472 Work-in-process consists of manufactured vials of OMIDRIA which have not been packaged into finished goods. |
Accrued Liabilities
Accrued Liabilities | 6 Months Ended |
Jun. 30, 2016 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities consisted of the following: June 30, December 31, (In thousands) Consulting and professional fees $ 2,898 $ 2,400 Employee compensation 2,729 2,590 Contract research and development 2,138 2,973 Other accruals 1,448 681 Clinical trials 1,239 1,108 Total accrued liabilities $ 10,452 $ 9,752 |
Notes Payable
Notes Payable | 6 Months Ended |
Jun. 30, 2016 | |
Debt Disclosure [Abstract] | |
Notes Payable | Notes Payable In December 2015, we entered into the Loan Agreement pursuant to which we borrowed $50.0 million . In May 2016, we entered into the First Amendment to the Loan Agreement (the Amendment) whereby we accelerated the borrowing of the additional $20.0 million potentially available to us under the Loan Agreement. After deducting all loan initiation costs, we received $19.9 million in net proceeds. The Amendment did not modify the interest rate or any terms or covenants of the Loan Agreement except to increase the final payment fee rate applicable to the additional $20.0 million borrowed from 5.25% to 6.25% reflecting the accelerated draw-down of the additional loan. As of June 30, 2016 , our outstanding principal balance is $70.0 million and our loan maturity fee is $5.0 million . Interest under the Loan Agreement accrues on the loans at an annual rate of 9.25% . Our monthly interest-only payments of $539,600 are due through July 1, 2017. Beginning August 1, 2017, monthly principal and interest payments of $2.6 million are due through the January 1, 2020 maturity date. In connection with the Amendment, we issued warrants to purchase an aggregate of 100,602 shares of Omeros common stock (the Warrants) to Oxford and EWB at the then current market price of $9.94 per share. We accounted for the Warrants as a discount to our notes payable. See Note 9 for further discussion of the Warrants. We accounted for the Amendment as a debt modification and, accordingly, the unamortized discount and debt issuance costs associated with the Loan Agreement are being amortized to interest expense using the effective interest method over the remaining term of the Loan Agreement. The Loan Agreement contains covenants that require us to maintain $10.0 million in restricted cash and certain eligible term investments and limit or restrict our ability to enter into certain transactions. In addition, we are required to either meet an annual OMIDRIA net revenue minimum for 2016 of $70.0 million and quarterly OMIDRIA revenue minimums in 2017 and 2018, or maintain 50% of the then-outstanding note payable balance in restricted cash and certain eligible term investments. The Loan Agreement also includes provisions related to events of default, the occurrence of a material adverse effect and changes of control. The occurrence of an event of default could result in the acceleration of the Loan Agreement and, under certain circumstances, could increase our interest rate by 5.0% per annum during the period of default. There was no event of default under the Loan Agreement as of June 30, 2016 . As of June 30, 2016 , the remaining unamortized discount and debt issuance costs associated with the debt were $5.1 million and $440,700 , respectively. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2016 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Development Milestones and Product Royalties We have retained control of worldwide commercial rights to OMIDRIA, to all of our product candidates and to our programs other than OMS103. We may be required, in connection with existing in-licensing or asset acquisition agreements, to make certain royalty and milestone payments and we cannot, at this time, determine when or if the related milestones will be achieved or whether the events triggering the commencement of payment obligations will occur. See Note 9 to our Consolidated Financial Statements for the year ended December 31, 2015 included in our Annual Report on Form 10-K as filed with the SEC on March 15, 2016. Contracts We have various agreements with third parties that collectively require payment of termination fees totaling $1.3 million as of June 30, 2016 if we cancel the work within specific time frames, either prior to commencing or during performance of the contracted services. Litigation As described within Note 9 of the “Notes to Consolidated Financial Statements” included in our Annual Report on Form 10-K for the year ended December 31, 2015 filed with the SEC on March 15, 2016, we filed a patent infringement lawsuit against Par Pharmaceutical, Inc. and its subsidiary, Par Sterile Products, LLC (collectively, Par) following our receipt of a Paragraph IV Notice Letter from Par stating that it had filed an Abbreviated New Drug Application (ANDA) seeking approval from the FDA to market a generic version of OMIDRIA before the expiration of three Orange Book-listed patents covering OMIDRIA. In each of April 2016 and August 2016, we amended the lawsuit to assert an additional OMIDRIA patent, both additional patents having been granted by the U.S. Patent and Trademark Office after Par sent its original Paragraph IV Notice Letter. In May 2016, Par stipulated to infringement of the first four asserted patents, and the court entered a partial judgment that Par’s filing of its ANDA constitutes an act of infringement of the claims of the first four asserted patents. Par maintains defenses and counterclaims alleging that the claims of the patents are invalid. The filing of our suit against Par triggered a stay of the FDA’s final approval of Par’s ANDA, which is expected to remain in effect until January 2018. We continue to believe that the assertions in Par’s Paragraph IV Notice Letter and its defenses and counterclaims asserted in the litigation that the asserted patent claims are allegedly invalid do not have merit, and we intend to defend our patents vigorously in the litigation against Par. |
Shareholders' Equity
Shareholders' Equity | 6 Months Ended |
Jun. 30, 2016 | |
Equity [Abstract] | |
Shareholders' Equity | Shareholders’ Equity Common Stock At Market Issuance Sales Agreement - In January 2016, we entered into the ATM Agreement with JonesTrading pursuant to which we may direct JonesTrading to sell shares of our common stock with an aggregate offering price of up to $100.0 million directly on The Nasdaq Global Market, through a market maker other than on an exchange or in negotiated transactions. Any sales made under the ATM Agreement are based solely on our instructions and JonesTrading will receive a 1.7% commission from the gross proceeds. The ATM Agreement may be terminated by either party at any time upon 10 days ' notice to the other party or by JonesTrading at any time in certain circumstances including the occurrence of a material adverse effect to Omeros. During the three and six months ended June 30, 2016, we sold 64,565 shares of our common stock at an average price of $11.41 per share under the ATM Agreement and received net proceeds of $724,000 . Securities Offering - In February 2015, we sold 3.4 million shares of our common stock at a public offering price of $20.03 per share and sold pre-funded warrants to purchase up to 749,250 shares of our common stock at a public offering price of $20.02 per pre-funded warrant share. The public offering price for the pre-funded warrants was equal to the public offering price of our common stock, less the $0.01 per share exercise price of each pre-funded warrant. After deducting underwriter discounts and offering expenses of $4.9 million , we received net proceeds from the offering of $79.1 million . For the six months ended June 30, 2016, we received proceeds of $1.9 million upon the exercise of stock options and pre-funded warrants which resulted in the issuance of 1,171,775 shares of common stock. Warrants In connection with the Amendment on May 18, 2016, we issued the Warrants to purchase an aggregate of 100,602 shares of our common stock to Oxford and EWB. We evaluated the terms of the Warrants and determined that the Warrants should be recorded as permanent equity. The aggregate fair value of the Warrants on the issue date was $758,000 , which we recorded as a discount to our notes payable. We are amortizing the Warrants over the remaining term of the Loan Agreement using the effective interest method. The Warrants are exercisable through May 18, 2023 at an exercise price per share of $9.94 per share. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation Stock-based compensation expense includes amortization of stock options granted to employees and non-employees and has been reported in our Condensed Consolidated Statements of Operations and Comprehensive Loss as follows: Three Months Ended Six Months Ended 2016 2015 2016 2015 (In thousands) (In thousands) Research and development $ 1,219 $ 1,229 $ 3,374 $ 2,554 Selling, general and administrative 1,391 1,151 3,657 2,344 Total $ 2,610 $ 2,380 $ 7,031 $ 4,898 In February 2016, in connection with our annual employee review process, we granted qualified employees options to purchase approximately 1.3 million shares of our common stock with an exercise price of $10.27 . The fair value of each option grant to employees and directors is estimated on the date of grant using the Black-Scholes option-pricing model. The following assumptions were applied to employee and director stock option grants during the periods ended: Three Months Ended Six Months Ended 2016 2015 2016 2015 Estimated weighted-average fair value $ 8.50 $ 12.63 $ 6.93 $ 12.97 Weighted-average assumptions Expected volatility 74 % 69 % 74 % 70 % Expected term, in years 5.8 5.9 5.7 5.9 Risk-free interest rate 1.37 % 1.71 % 1.40 % 1.61 % Expected dividend yield — % — % — % — % Stock option activity for all stock plans and related information is as follows: Options Outstanding Weighted- Average Exercise Price per Share Remaining Contractual Life (In years) Aggregate Intrinsic Value (In thousands) Balance at December 31, 2015 8,310,235 $ 7.97 Granted 1,663,155 10.84 Exercised (422,525 ) 4.42 Forfeited (49,047 ) 14.02 Balance at June 30, 2016 9,501,818 $ 8.60 6.44 $ 23,678 Vested and expected to vest at June 30, 2016 9,225,654 $ 8.51 6.36 $ 23,615 Exercisable at June 30, 2016 6,764,948 $ 7.41 5.45 $ 23,051 At June 30, 2016 , excluding non-employee stock options, the total estimated compensation expense to be recognized in connection with our unvested options is $16.6 million , and 1,896,593 shares were available to grant. |
Organization and Significant 16
Organization and Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2016 | |
Accounting Policies [Abstract] | |
Basis of Presentation | Basis of Presentation Our condensed consolidated financial statements include the financial position and results of operations of Omeros Corporation (Omeros) and our wholly owned subsidiaries. All inter-company transactions have been eliminated and we have determined we operate in one segment. The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with U.S. generally accepted accounting principles (GAAP) for interim financial information and with the instructions to Form 10-Q and Rule 10-01 of Regulation S-X. The information as of June 30, 2016 and for the three and six months ended June 30, 2016 and 2015 includes all adjustments, which include normal recurring adjustments, necessary to present fairly our interim financial information. The Condensed Consolidated Balance Sheet at December 31, 2015 has been derived from our audited financial statements but does not include all of the information and footnotes required by GAAP for audited annual financial information. The accompanying unaudited condensed consolidated financial statements and related notes thereto should be read in conjunction with the audited consolidated financial statements and related notes thereto that are included in our Annual Report on Form 10-K for the year ended December 31, 2015 , which was filed with the U.S. Securities and Exchange Commission (SEC) on March 15, 2016. The accompanying unaudited condensed consolidated financial statements have been prepared on a going-concern basis, which contemplates the realization of assets and the satisfaction of liabilities in the normal course of business. The accompanying unaudited condensed consolidated financial statements do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from uncertainty related to our ability to continue as a going concern. |
Revenue Recognition | Product Sales, Net We record revenue from OMIDRIA sales when the product is delivered to our wholesalers. Product sales are recorded net of estimated chargebacks and rebates, wholesaler distribution fees and estimated product returns. Accruals or allowances are established for these deductions when revenue is recognized, and actual amounts incurred are offset against the applicable accruals and allowances. We reflect each of these accruals or allowances as either a reduction in the related accounts receivable or as an accrued liability, depending on how the accrual or allowance is settled. Use of |
Use of Estimates | Use of Estimates The preparation of financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the amounts reported in the financial statements and accompanying notes. Significant items subject to such estimates include revenue recognition, fair market value of investments, stock-based compensation expense and accruals for clinical trials and contingencies. We base our estimates on historical experience and on various other factors that we believe are reasonable under the circumstances; however, actual results could differ from these estimates. |
Recent Accounting Pronouncements | Recently Adopted Accounting Pronouncements For the year ended December 31, 2015 we adopted and applied retrospectively Financial Accounting Standards Board (FASB) Accounting Standards Update, or ASU, No. 2015-03, related to simplifying the presentation of debt issuance costs. This standard requires debt issuance costs related to a recognized debt liability to be presented in the balance sheet as a direct deduction to the liability. Recent Accounting Pronouncements In August 2014, FASB issued ASU No. 2014-15 related to disclosure of an entity’s ability to continue as a going concern. This standard requires management to evaluate whether substantial doubt exists regarding the entity’s ability to continue as a going concern at each reporting period for a duration of one year after the date the financial statements are issued or available to be issued and to provide related footnote disclosures. This standard must be applied prospectively and is effective for interim and annual periods ending after December 15, 2016. We are monitoring for any conditions and events that could raise substantial doubt about our ability to continue as a going concern. The evaluation of the significance of those conditions and events and the related impact upon our disclosures, if applicable, will be disclosed in our annual financial statements for the year ended December 31, 2016. In February 2016, FASB issued ASU 2016-02 related to lease accounting. This standard requires lessees to recognize a right-of-use asset and a lease liability for most leases. This standard must be applied using a modified retrospective transition and is effective for all annual and interim periods beginning after December 15, 2018. Earlier adoption is permitted. We are evaluating how this new standard will impact the presentation of our financial statements and related disclosures. In March 2016, FASB issued ASU 2016-08 related to revenue recognition. This standard is an amendment to ASU 2014-09 relating to revenue from contracts with customers. This amendment clarifies an entity’s revenue recognition for a performance obligation based on principal versus agent considerations. This standard has the same effective date and transition requirements as ASU 2014-09, as amended, which requires that the guidance must be applied retroactively to each prior reporting period presented or retrospectively with the cumulative effect of applying the standard recognized in the period adopted. As amended, the standard is effective for interim and annual periods beginning after December 15, 2017 and cannot be adopted before the original effective date, which was for periods beginning after December 15, 2016. We are currently evaluating the impact that this standard may have on our financial statements once it is adopted. In March 2016, FASB issued ASU 2016-09 that changes the accounting for certain aspects of share-based payments to employees. The guidance requires the recognition of the income tax effects of awards in the income statement when the awards vest or are settled, thus eliminating additional paid in capital pools. The guidance also allows for the employer to repurchase more of an employee’s shares for tax withholding purposes without triggering liability accounting and for making a policy election to account for forfeitures as they occur rather than on an estimated basis. The guidance is effective for interim and annual periods beginning after December 15, 2016 with early adoption permitted. We are currently evaluating the impact that this standard may have on our financial statements once it is adopted and the timing of adoption. In April and May 2016, FASB issued ASU 2016-10 and ASU 2016-12, respectively. Both standards are amendments to ASU 2014-09 related to revenue from contracts with customers. ASU 2016-10 clarifies an entity’s revenue recognition when identifying performance obligations and licensing. ASU 2016-12 clarifies the objective of the collectibility criterion, one of the five steps of ASU 2014-09. This amendment also establishes practical expedients for sales-tax considerations and contract modifications. Both standards have the same effective date and transition requirements as ASU 2014-09, as amended. We are currently evaluating the impact that these standards may have on our financial statements once they are adopted. |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Earnings Per Share [Abstract] | |
Calculation of Historical Outstanding Dilutive Securities Not Included in Diluted Loss per Share | Potentially dilutive securities excluded from the diluted loss per share calculation are as follows: June 30, 2016 2015 Outstanding options to purchase common stock 9,501,818 8,427,501 Warrants and pre-funded warrants to purchase common stock 100,602 1,149,249 Total 9,602,420 9,576,750 |
Fair-Value Measurements (Tables
Fair-Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Fair Value Disclosures [Abstract] | |
Financial Assets and Liabilities Measured at Fair Value on Recurring Basis | Our fair value hierarchy for our financial assets and liabilities measured at fair value on a recurring basis are as follows: June 30, 2016 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted cash and investments $ 10,679 $ — $ — $ 10,679 Money-market funds classified as short-term investments 16,648 — — 16,648 Total $ 27,327 $ — $ — $ 27,327 December 31, 2015 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted cash and investments $ 10,679 $ — $ — $ 10,679 Money-market funds classified as short-term investments 26,898 — — 26,898 Total $ 37,577 $ — $ — $ 37,577 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | he components of inventory are as follows: June 30, December 31, (In thousands) Raw materials $ 101 $ 93 Work-in-process 1,559 158 Finished goods 120 221 Total inventory $ 1,780 $ 472 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued liabilities consisted of the following: June 30, December 31, (In thousands) Consulting and professional fees $ 2,898 $ 2,400 Employee compensation 2,729 2,590 Contract research and development 2,138 2,973 Other accruals 1,448 681 Clinical trials 1,239 1,108 Total accrued liabilities $ 10,452 $ 9,752 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2016 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation Expense | Stock-based compensation expense includes amortization of stock options granted to employees and non-employees and has been reported in our Condensed Consolidated Statements of Operations and Comprehensive Loss as follows: Three Months Ended Six Months Ended 2016 2015 2016 2015 (In thousands) (In thousands) Research and development $ 1,219 $ 1,229 $ 3,374 $ 2,554 Selling, general and administrative 1,391 1,151 3,657 2,344 Total $ 2,610 $ 2,380 $ 7,031 $ 4,898 |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions | The following assumptions were applied to employee and director stock option grants during the periods ended: Three Months Ended Six Months Ended 2016 2015 2016 2015 Estimated weighted-average fair value $ 8.50 $ 12.63 $ 6.93 $ 12.97 Weighted-average assumptions Expected volatility 74 % 69 % 74 % 70 % Expected term, in years 5.8 5.9 5.7 5.9 Risk-free interest rate 1.37 % 1.71 % 1.40 % 1.61 % Expected dividend yield — % — % — % — % |
Stock Option Activity and Related Information | Stock option activity for all stock plans and related information is as follows: Options Outstanding Weighted- Average Exercise Price per Share Remaining Contractual Life (In years) Aggregate Intrinsic Value (In thousands) Balance at December 31, 2015 8,310,235 $ 7.97 Granted 1,663,155 10.84 Exercised (422,525 ) 4.42 Forfeited (49,047 ) 14.02 Balance at June 30, 2016 9,501,818 $ 8.60 6.44 $ 23,678 Vested and expected to vest at June 30, 2016 9,225,654 $ 8.51 6.36 $ 23,615 Exercisable at June 30, 2016 6,764,948 $ 7.41 5.45 $ 23,051 |
Organization and Significant 22
Organization and Significant Accounting Policies (Detail) | 6 Months Ended | ||
Jun. 30, 2016USD ($)segment | Mar. 31, 2018USD ($) | Mar. 31, 2017USD ($) | |
Number of operating segments | segment | 1 | ||
Cash, cash equivalents and short-term investments | $ 21,200,000 | ||
Oxford EWB Loan | |||
Outstanding balance | 70,000,000 | ||
Debt instrument, covenant compliance, minimum annual net revenue requirements | $ 70,000,000 | ||
Debt instrument, covenant compliance, minimum restricted cash and eligible term investments as a percent of outstanding balance | 50.00% | ||
Oxford EWB Loan | Forecast | |||
Debt instrument, covenant compliance, minimum quarterly net revenue requirements | $ 30,000,000 | $ 25,000,000 | |
Cash and Eligible Investments | |||
Restricted cash and investments | $ 10,000,000 | ||
Cash | |||
Restricted cash and investments | $ 679,000 |
Net Loss Per Share - Calculatio
Net Loss Per Share - Calculation of Historical Outstanding Dilutive Securities Not Included in Diluted Loss Per Share (Detail) - shares | 6 Months Ended | |
Jun. 30, 2016 | Jun. 30, 2015 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Outstanding dilutive securities not included in diluted loss per share calculation | 9,602,420 | 9,576,750 |
Outstanding options to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Outstanding dilutive securities not included in diluted loss per share calculation | 9,501,818 | 8,427,501 |
Warrants and pre-funded warrants to purchase common stock | ||
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Outstanding dilutive securities not included in diluted loss per share calculation | 100,602 | 1,149,249 |
Fair-Value Measurements - Finan
Fair-Value Measurements - Financial Assets and Liabilities Measured at Fair Value on Recurring Basis (Detail) - Fair Value, Measurements, Recurring - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total | $ 27,327 | $ 37,577 |
Restricted Cash, Noncurrent | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 10,679 | 10,679 |
Short-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 16,648 | 26,898 |
Fair Value, Inputs, Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total | 27,327 | 37,577 |
Fair Value, Inputs, Level 1 | Restricted Cash, Noncurrent | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 10,679 | 10,679 |
Fair Value, Inputs, Level 1 | Short-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 16,648 | 26,898 |
Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total | 0 | 0 |
Fair Value, Inputs, Level 2 | Restricted Cash, Noncurrent | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 0 | 0 |
Fair Value, Inputs, Level 2 | Short-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 0 | 0 |
Fair Value, Inputs, Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total | 0 | 0 |
Fair Value, Inputs, Level 3 | Restricted Cash, Noncurrent | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 0 | 0 |
Fair Value, Inputs, Level 3 | Short-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | $ 0 | $ 0 |
Fair-Value Measurements - Narra
Fair-Value Measurements - Narrative (Detail) - USD ($) | 6 Months Ended | 12 Months Ended |
Jun. 30, 2016 | Dec. 31, 2015 | |
Fair Value Disclosures [Abstract] | ||
Cash excluded from fair value hierarchy disclosure | $ 4,600,000 | $ 1,400,000 |
Unrealized gain (loss) on investments | $ 0 | $ 0 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 101 | $ 93 |
Work-in-process | 1,559 | 158 |
Finished goods | 120 | 221 |
Inventory | $ 1,780 | $ 472 |
Accrued Liabilities - Accrued L
Accrued Liabilities - Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2016 | Dec. 31, 2015 |
Payables and Accruals [Abstract] | ||
Consulting and professional fees | $ 2,898 | $ 2,400 |
Employee compensation | 2,729 | 2,590 |
Contract research and development | 2,138 | 2,973 |
Other accruals | 1,448 | 681 |
Clinical trials | 1,239 | 1,108 |
Total accrued liabilities | $ 10,452 | $ 9,752 |
Notes Payable (Detail)
Notes Payable (Detail) - USD ($) | Aug. 01, 2017 | May 31, 2016 | Jun. 30, 2016 | May 18, 2016 | Dec. 31, 2015 | Feb. 28, 2015 |
Debt Instrument [Line Items] | ||||||
Shares of common stock to purchase by warrant (in shares) | 749,250 | |||||
Warrant exercise price (in USD per share) | $ 0.01 | |||||
Oxford EWB Loan | ||||||
Debt Instrument [Line Items] | ||||||
Debt instrument, face amount | $ 50,000,000 | |||||
Debt instrument, additional borrowing under first amendment | $ 20,000,000 | |||||
Proceeds from debt issuance | $ 19,900,000 | |||||
Maturity fee, as a percent | 5.25% | |||||
Maturity fee on amended balance, as a percent | 6.25% | |||||
Outstanding balance | $ 70,000,000 | |||||
Loan maturity fee | $ 5,000,000 | |||||
Stated interest rate | 9.25% | |||||
Monthly interest only payments | $ 539,600 | |||||
Shares of common stock to purchase by warrant (in shares) | 100,602 | 100,602 | ||||
Warrant exercise price (in USD per share) | $ 9.94 | $ 9.94 | ||||
Debt instrument, covenant compliance, minimum restricted cash and certain eligible short term investments | 10,000,000 | |||||
Debt instrument, covenant compliance, minimum annual net revenue requirements | $ 70,000,000 | |||||
Debt instrument, covenant compliance, minimum restricted cash and eligible term investments as a percent of outstanding balance | 50.00% | |||||
Potential additional default interest | 5.00% | |||||
Unamortized balance of debt discount | $ 5,100,000 | |||||
Unamortized balance of debt issuance costs | $ 441,000 | |||||
Oxford EWB Loan | Forecast | ||||||
Debt Instrument [Line Items] | ||||||
Monthly principal and interest payments | $ 2,600,000 |
Commitments and Contingencies C
Commitments and Contingencies Contracts (Details) $ in Millions | 6 Months Ended |
Jun. 30, 2016USD ($) | |
Commitments and Contingencies Disclosure [Abstract] | |
Liabilities Subject to Compromise, Early Contract Termination Fees | $ 1.3 |
Shareholders' Equity (Detail)
Shareholders' Equity (Detail) - USD ($) | 1 Months Ended | 3 Months Ended | 6 Months Ended | ||||
Jan. 31, 2016 | Feb. 28, 2015 | Jun. 30, 2016 | Jun. 30, 2016 | Jun. 30, 2015 | May 31, 2016 | May 18, 2016 | |
Class of Stock [Line Items] | |||||||
Stock issued during period | 3,400,000 | ||||||
Share price (in USD per share) | $ 20.03 | ||||||
Proceeds from issuance of common stock and pre-funded warrants, net | $ 79,100,000 | $ 724,000 | $ 79,076,000 | ||||
Shares of common stock to purchase by warrant (in shares) | 749,250 | ||||||
Warrant exercise price (in USD per share) | $ 0.01 | ||||||
Offering expenses and underwriter discounts | $ 4,900,000 | ||||||
Proceeds from warrant exercises | $ 1,900,000 | ||||||
Warrants exercised during period | 1,171,775 | ||||||
Pre-funded Warrants | |||||||
Class of Stock [Line Items] | |||||||
Share price (in USD per share) | $ 20.02 | ||||||
At The Market (ATM) Program | |||||||
Class of Stock [Line Items] | |||||||
Aggregate offering price for ATM program | $ 100,000,000 | ||||||
Stock offering ATM program, commission percent | 1.70% | ||||||
Stock offering ATM program, notice period for termination | 10 days | ||||||
Stock issued during period | 64,565 | ||||||
Proceeds from issuance of common stock and pre-funded warrants, net | $ 724,000 | ||||||
At The Market (ATM) Program | Weighted Average | |||||||
Class of Stock [Line Items] | |||||||
Share price (in USD per share) | $ 11.41 | $ 11.41 | |||||
Oxford EWB Loan | |||||||
Class of Stock [Line Items] | |||||||
Shares of common stock to purchase by warrant (in shares) | 100,602 | 100,602 | |||||
Warrant exercise price (in USD per share) | $ 9.94 | $ 9.94 | |||||
Oxford EWB Loan | Long-term Debt | |||||||
Class of Stock [Line Items] | |||||||
Warrant fair value | $ 758,000 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Detail) - USD ($) $ / shares in Units, $ in Millions | 1 Months Ended | 6 Months Ended |
Feb. 29, 2016 | Jun. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted (shares) | 1,663,155 | |
Granted (USD per share) | $ 10.84 | |
Unrecognized compensation expense | $ 16.6 | |
Equity Incentive Plan 2008 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Shares available for future grants | 1,896,593 | |
Stock options | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Granted (shares) | 1,300,000 | |
Granted (USD per share) | $ 10.27 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total | $ 2,610 | $ 2,380 | $ 7,031 | $ 4,898 |
Research and Development Expense | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 1,219 | 1,229 | 3,374 | 2,554 |
Selling, General and Administrative Expenses | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 1,391 | $ 1,151 | $ 3,657 | $ 2,344 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Employee Option Grant Estimated on Date of Grant (Details) - Equity Option - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2016 | Jun. 30, 2015 | Jun. 30, 2016 | Jun. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Estimated weighted-average fair value (USD per share) | $ 8.50 | $ 12.63 | $ 6.93 | $ 12.97 |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||||
Expected volatility | 74.00% | 69.00% | 74.00% | 70.00% |
Weighted Average | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||||
Expected term, in years | 5 years 9 months 25 days | 5 years 10 months 24 days | 5 years 8 months 15 days | 5 years 11 months 8 days |
Risk-free interest rate | 1.37% | 1.71% | 1.40% | 1.61% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity and Related Information (Detail) $ / shares in Units, $ in Thousands | 6 Months Ended |
Jun. 30, 2016USD ($)$ / sharesshares | |
Options Outstanding | |
Beginning balance (shares) | shares | 8,310,235 |
Granted (shares) | shares | 1,663,155 |
Exercised (shares) | shares | (422,525) |
Forfeited (shares) | shares | (49,047) |
Ending balance (shares) | shares | 9,501,818 |
Vested and expected to vest (shares) | shares | 9,225,654 |
Exercisable (shares) | shares | 6,764,948 |
Weighted-Average Exercise Price per Share | |
Beginning balance (USD per share) | $ / shares | $ 7.97 |
Granted (USD per share) | $ / shares | 10.84 |
Exercised (USD per share) | $ / shares | 4.42 |
Forfeited (USD per share) | $ / shares | 14.02 |
Ending balance (USD per share) | $ / shares | 8.60 |
Vested and expected to vest (USD per share) | $ / shares | 8.51 |
Exercisable (USD per share) | $ / shares | $ 7.41 |
Weighted- Average Remaining Contractual Life | |
Balance (in years) | 6 years 5 months 8 days |
Vested and expected to vest (in years) | 6 years 4 months 9 days |
Exercisable (in years) | 5 years 5 months 12 days |
Aggregate Intrinsic Value | |
Balance | $ | $ 23,678 |
Vested and expected to vest | $ | 23,615 |
Exercisable | $ | $ 23,051 |