Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2017 | Aug. 04, 2017 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2017 | |
Document Fiscal Year Focus | 2,017 | |
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 | 44,803,848 |
CONDENSED CONSOLIDATED BALANCE
CONDENSED CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Current assets: | ||
Cash and cash equivalents | $ 3,386 | $ 2,224 |
Short-term investments | 26,281 | 43,107 |
Receivables | 19,075 | 12,037 |
Inventory | 905 | 1,128 |
Prepaid expense | 3,446 | 1,766 |
Total current assets | 53,093 | 60,262 |
Property and equipment, net | 1,426 | 1,181 |
Restricted cash and investments | 5,835 | 5,835 |
Total assets | 60,354 | 67,278 |
Current liabilities: | ||
Accounts payable | 2,572 | 2,519 |
Accrued expenses | 21,643 | 13,252 |
Current portion of deferred rent | 288 | 102 |
Current portion of lease financing obligations | 250 | 198 |
Total current liabilities | 24,753 | 16,071 |
Notes payable and lease financing obligations, net | 81,511 | 79,512 |
Deferred rent | 8,940 | 9,142 |
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, 2017 and December 31, 2016 | 0 | 0 |
Common stock, par value $0.01 per share, 150,000,000 shares authorized at June 30, 2017 and December 31, 2016; 44,447,603 and 43,819,133 issued and outstanding at June 30, 2017 and December 31, 2016, respectively | 444 | 438 |
Additional paid-in capital | 444,041 | 432,002 |
Accumulated deficit | (499,335) | (469,887) |
Total shareholders’ deficit | (54,850) | (37,447) |
Total liabilities and shareholders’ deficit | $ 60,354 | $ 67,278 |
CONDENSED CONSOLIDATED BALANCE3
CONDENSED CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2017 | Dec. 31, 2016 |
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 | 44,447,603 | 43,819,133 |
Common stock, outstanding shares | 44,447,603 | 43,819,133 |
CONDENSED CONSOLIDATED STATEMEN
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Income Statement [Abstract] | ||||
Product sales, net | $ 17,151 | $ 10,004 | $ 29,408 | $ 17,250 |
Grant revenue | 0 | 0 | 0 | 173 |
Revenue | 17,151 | 10,004 | 29,408 | 17,423 |
Costs and expenses | ||||
Cost of product sales | 157 | 327 | 429 | 654 |
Research and development | 13,137 | 10,231 | 25,377 | 25,665 |
Selling, general and administrative | 15,796 | 10,375 | 28,267 | 21,485 |
Total costs and expenses | 29,090 | 20,933 | 54,073 | 47,804 |
Loss from operations | (11,939) | (10,929) | (24,665) | (30,381) |
Interest expense | (2,723) | (1,857) | (5,386) | (3,232) |
Other income (expense), net | 303 | 174 | 603 | 462 |
Net loss | (14,359) | (12,612) | (29,448) | (33,151) |
Comprehensive loss | $ (14,359) | $ (12,612) | $ (29,448) | $ (33,151) |
Basic and diluted net loss per share (USD per share) | $ (0.33) | $ (0.32) | $ (0.67) | $ (0.86) |
Weighted-average shares used to compute basic and diluted net loss per share (shares) | 44,037,471 | 39,178,547 | 43,933,022 | 38,747,816 |
CONDENSED CONSOLIDATED STATEME5
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2017 | Jun. 30, 2016 | |
Operating activities: | ||
Net loss | $ (29,448) | $ (33,151) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Depreciation and amortization | 234 | 122 |
Stock-based compensation expense | 6,408 | 7,031 |
Non-cash interest expense | 2,012 | 684 |
Changes in operating assets and liabilities: | ||
Receivables | (7,038) | (2,289) |
Inventory | 223 | (1,308) |
Prepaid expenses and other assets | (1,680) | (242) |
Accounts payable and accrued expenses | 8,428 | (270) |
Deferred rent | ||
Net cash used in operating activities | (20,861) | (29,423) |
Investing activities: | ||
Purchases of property and equipment | (316) | (34) |
Purchases of investments | (1,102) | (20,625) |
Proceeds from the sale and maturities of investments | 17,928 | 30,875 |
Net cash provided by investing activities | 16,510 | 10,216 |
Financing activities: | ||
Proceeds from issuance of common stock and pre-funded warrants | 0 | 724 |
Proceeds from borrowings under notes payable | 0 | 19,864 |
Payments on notes payable and lease financing obligations | (124) | (34) |
Proceeds upon exercise of stock options and warrants | 5,637 | 1,877 |
Net cash provided by financing activities | 5,513 | 22,431 |
Net increase in cash and cash equivalents | 1,162 | 3,224 |
Cash and cash equivalents at beginning of period | 2,224 | 1,365 |
Cash and cash equivalents at end of period | 3,386 | 4,589 |
Supplemental cash flow information | ||
Cash paid for interest | 3,372 | 2,005 |
Conversion of accrued interest to notes payable | 1,628 | 0 |
Property acquired under capital lease | 163 | 388 |
Property acquired under capital lease | $ 0 | $ 758 |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2017 | |
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. Common share equivalents are excluded from the diluted net loss per share computation if their effect is anti-dilutive. The basic and diluted net loss per share amounts for the three and six months ended June 30, 2017 and 2016 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, 2017 2016 Outstanding options to purchase common stock 10,334,730 9,501,818 Outstanding warrants to purchase common stock 100,602 100,602 Total 10,435,332 9,602,420 |
Organization and Significant Ac
Organization and Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2017 | |
Accounting Policies [Abstract] | |
Organization and Significant Accounting Policies | Organization and Significant Accounting Policies Organization We are a commercial-stage biopharmaceutical company committed to discovering, developing and commercializing small-molecule and protein therapeutics for large-market as well as orphan indications targeting inflammation, complement-mediated diseases 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) and in the European Economic Area for use during cataract surgery or intraocular lens replacement. 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, 2017 and for the three and six months ended June 30, 2017 and 2016 includes all adjustments, which include normal recurring adjustments, necessary to present fairly our interim financial information. The Condensed Consolidated Balance Sheet at December 31, 2016 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, 2016 , which was filed with the U.S. Securities and Exchange Commission (SEC) on March 16, 2017. Going Concern We have the responsibility to evaluate, based on the provisions of the Financial Accounting Standards Board (FASB) Accounting Standards Update (ASU) No. 2014-15, Presentation of Financial Statements - Going Concern (ASU 2014-15), whether conditions and/or events raise substantial doubt about our ability to meet our future financial obligations as they become due within one year after the date that these financial statements are issued. Our initial step in the evaluation does not take into consideration the potential mitigating effects of our plans that have not been fully implemented as of the date the financial statements are issued ( e.g., continuing to grow revenues from the sales of OMIDRIA, establishing corporate partnerships or licensing agreements, future available debt financing, etc.) In performing the first step of this assessment, the derived result is that the following conditions raise substantial doubt about our ability to meet our financial obligations as they become due. We have a history of net losses ( $66.7 million in 2016 and $29.4 million for the six months ended June 30, 2017 ) and use significant cash in operating activities ( $51.5 million in 2016 and $20.9 million for the six months ended June 30, 2017 ). As of June 30, 2017 , we had $29.7 million in cash, cash equivalents and short-term investments available to fund operations and debt service costs. We expect to continue to incur negative cash flows until such time as OMIDRIA product sales or other sources of revenue ( e.g. , corporate partnering or licensing) generate sufficient cash inflows to finance our operations and debt service requirements (which debt service will be at least $6.8 million through August 8, 2018). In addition, we also considered that pass-through reimbursement for our commercial product, OMIDRIA, is currently due to expire as of January 1, 2018 if we do not secure similar or separate reimbursement prior to that time. In performing the second step of this assessment, we are required to evaluate under ASU 2014-15 whether our plans to mitigate the conditions above alleviate the substantial doubt about our ability to meet our obligations as they become due within one year after the date that these financial statements are issued. Our future plans include securing continued separate reimbursement (or equivalent reimbursement treatment) for OMIDRIA beyond the January 1, 2018 expiration of pass-through reimbursement, and/ or continuing to grow OMIDRIA revenues, and additional funding sources may include establishing corporate partnerships, establishing collaboration and licensing revenue agreements, sale of assets, and issuing public or private equity securities, including selling common stock through our At Market Issuance Sales Agreement (ATM Agreement) with JonesTrading Institutional Services LLC (JonesTrading) (see Note 9 for further detail). We also have the ability, at our election, to borrow an additional $25.0 million that is currently available under our existing CRG Loan Agreement through September 2017. In addition, under the CRG Loan Agreement we have the ability to borrow an additional $20.0 million beyond the above-noted $25.0 million if our OMIDRIA net product sales exceed $25.0 million or if our average market capitalization averages at least $1.0 billion for any consecutive three-month period on or prior to December 31, 2017 (see Note 7 for further detail). While an additional $25.0 million is currently available at our election under the CRG Loan Agreement and an additional $20.0 million may become available, the other sources of working capital are not currently assured, and consequently these sources of capital may not sufficiently mitigate the risks and uncertainties disclosed above. We have therefore concluded, based on the provisions of ASU 2014-15, that there is substantial doubt about our ability to continue as a going concern through August 8, 2018. 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. Product Sales, Net We record revenue from product sales when the product is delivered to our wholesalers. Product sales to a wholesaler are not recorded if we determine that the wholesaler’s on-hand OMIDRIA inventory, based on sell-through and inventory information we regularly receive from our wholesalers, exceeds approximately eight weeks of projected demand. Product sales are recorded net of wholesaler distribution fees and estimated chargebacks, product returns, rebates and purchase volume discounts. Accruals or allowances are established for these deductions in the same period when revenue is recognized, and actual amounts incurred are offset against the applicable accruals or allowances. We reflect each of these accruals or allowances as either a reduction in the related account receivable or as an accrued liability, depending on how the amount is expected to be 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. Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board, (FASB), issued amended guidance related to revenue from contracts with customers. The amended guidance introduces a new principles-based framework for revenue recognition and disclosure. Since its issuance FASB has issued five Accounting Standards Updates, (ASUs), amending the guidance and effective date, and the SEC has rescinded certain related guidance; the most recent of which was issued in December 2016. The effective date of the guidance requires us to adopt the standard at the beginning of our first quarter of fiscal 2018 with earlier application permitted. The new guidance requires either a modified retrospective method or a full retrospective method of transition. We currently anticipate adopting the guidance at the beginning of our first quarter of fiscal 2018 under the modified retrospective method. We currently do not anticipate a material impact on our revenue recognition practices. We continue to review variable consideration, potential disclosures, and our method of adoption to complete our evaluation of the impact on our consolidated financial statements. In addition, we continue to monitor additional changes, modifications, clarifications or interpretations undertaken by the FASB, which may impact our current conclusions. In February 2016, the 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 method 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 May 2016, the FASB issued ASU 2017-09, Compensation - Stock Compensation (Topic 718), which effectively amends previous issued guidance and provides clarity and consistency in practice on the accounting for changes to the terms and conditions of stock-based payment arrangement. This standard is effective for all annual and interim periods beginning after December 15, 2017 and is applied prospectively to modifications occurring after the adoption date. Earlier adoption is permitted. We do not anticipate a material change upon adoption. |
Cash, Cash Equivalents and Inve
Cash, Cash Equivalents and Investments | 6 Months Ended |
Jun. 30, 2017 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents and Investments | Cash, Cash Equivalents and Investments As of June 30, 2017 and December 31, 2016 , all investments are classified as short-term and available-for-sale on the accompanying Condensed Consolidated Balance Sheets. 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, 2017 | |
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, 2017 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted cash and investments $ 5,835 $ — $ — $ 5,835 Money-market funds classified as short-term investments 26,281 — — 26,281 Total $ 32,116 $ — $ — $ 32,116 December 31, 2016 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted cash and investments $ 5,835 $ — $ — $ 5,835 Money-market funds classified as short-term investments 43,107 — — 43,107 Total $ 48,942 $ — $ — $ 48,942 Cash held in demand deposit accounts of $3.4 million and $2.2 million is excluded from our fair-value hierarchy disclosure as of June 30, 2017 and December 31, 2016 , respectively. There were no unrealized gains or losses associated with our short-term investments as of June 30, 2017 or December 31, 2016 . The carrying amounts reported in the accompanying Condensed Consolidated Balance Sheets for receivables, accounts payable, other current monetary assets and liabilities and notes payable and lease financing obligations approximate fair value. |
Inventory (Notes)
Inventory (Notes) | 6 Months Ended |
Jun. 30, 2017 | |
Inventory Disclosure [Abstract] | |
Inventory | Inventory The components of inventory are as follows: June 30, December 31, (In thousands) Raw materials $ 101 $ 101 Work-in-process 537 854 Finished goods 267 173 Total inventory $ 905 $ 1,128 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, 2017 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities consist of the following: June 30, December 31, (In thousands) Employee compensation and related taxes $ 5,147 $ 4,551 Contract research and development 4,541 3,030 Consulting and professional fees 4,484 2,223 Sales rebates and discounts 3,767 1,335 Clinical trials 964 1,167 Other accruals 2,740 946 Total accrued liabilities $ 21,643 $ 13,252 |
Notes Payable
Notes Payable | 6 Months Ended |
Jun. 30, 2017 | |
Debt Disclosure [Abstract] | |
Notes Payable | Notes Payable Notes payable and lease financing obligations consist of the following: June 30, December 31, 2016 (in thousands) Notes payable $ 82,143 $ 80,516 Lender facility fee payable upon maturity 4,107 4,025 Lease financing obligations 561 522 Notes payable, facility fee and lease financing obligations 86,811 85,063 Unamortized debt discount (3,755 ) (3,958 ) Unamortized debt issuance costs (1,295 ) (1,395 ) Current portion of lease financing obligations (250 ) (198 ) Non-current portion of notes payable and lease financing obligations, net $ 81,511 $ 79,512 In October 2016, we entered into the CRG Loan Agreement, which requires that we make interest-only payments through December 31, 2020. Subject to the achievement of certain milestones, this interest-only period potentially could be extended through the maturity date of September 30, 2022. In November 2016, we borrowed $80.0 million under the CRG Loan Agreement and repaid our then-outstanding notes payable. In May 2017, CRG agreed that we can access, at our election, the $25.0 million available in the next tranche under the CRG Loan Agreement through September 19, 2017. We also have the ability to borrow an additional $20.0 million if we achieve OMIDRIA net product sales of at least $25.0 million or an average market capitalization of at least $1.0 billion for any consecutive three-month period ending on or prior to December 31, 2017, and the borrowing occurs on or prior to March 21, 2018. The CRG Loan Agreement accrues interest at an annual rate of 12.25% ( 4.00% of which can be deferred at our option through December 31, 2020 by adding such amount to the aggregate principal amount). As of June 30, 2017, as allowed under the CRG Loan Agreement, we have deferred $2.1 million ( $1.6 million for the six months ended June 30, 2017 ) of interest due by increasing the principal amount outstanding. The CRG Loan Agreement requires us to maintain cash and cash equivalents of $5.0 million during the term of the agreement which is recorded as restricted cash and investments in our Condensed Consolidated Balance Sheet. We are also required to pay a facility fee equal to 5.00% of the aggregate principal amount borrowed (including principal additions related to deferred interest) on repayment of the CRG Loan Agreement. The facility fee is being accreted to notes payable using the effective interest method over the term of the CRG Loan Agreement. We may prepay all or a portion of the outstanding principal under the CRG Loan Agreement at any time upon prior notice subject to a prepayment fee through September 30, 2019, with no prepayment fee being owed thereafter. In certain circumstances, including a change of control and certain asset sales or licensing transactions, we are required to prepay all or a portion of the loan, including the applicable prepayment premium on the outstanding principal to be prepaid. The CRG Loan Agreement requires us to achieve either (a) certain minimum net revenue amounts through the end of 2021, which are $55.0 million and $65.0 million for the 2017 and 2018 calendar years, respectively, or (b) a minimum market capitalization threshold equal to the product of 6.4 multiplied by the aggregate principal amount of loans outstanding under the CRG Loan Agreement, determined as of the fifth business day following announcement of earnings results for the applicable year. If we are unable to satisfy the minimum annual revenue requirement or the market capitalization threshold for any given year, we may avoid a related default by repaying the shortfall between actual revenues and the minimum revenue requirement for such year using proceeds generated by an equity or subordinated debt issuance. The CRG Loan Agreement includes customary events of default (see Note 7 of the “Notes to Consolidated Financial Statements” included in our Annual Report on Form 10-K for the year ended December 31, 2016). If there is an event of default the lenders may have the right to accelerate all of our repayment obligations under the CRG Loan Agreement and to take control of our pledged assets, which consists of substantially all of our assets including our intellectual property. Under certain circumstances, a default interest rate of an additional 4.00% per annum will apply to all outstanding obligations during the existence of an event of default. There was no event of default under the CRG Loan Agreement as of June 30, 2017 . |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2017 | |
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 8 to our Consolidated Financial Statements for the year ended December 31, 2016 included in our Annual Report on Form 10-K. Contracts We have various agreements with third parties that collectively require payment of termination fees totaling $3.7 million as of June 30, 2017 if we cancel work within specific time frames, either prior to commencing or during performance of the contracted services. This is in addition to fees associated with the CRG Loan Agreement (see Note 7) and within the Contractual Obligations and Commitments and Financial Condition - Liquidity and Capital Resources sections of Management’s Discussion and Analysis. Litigation As described within Note 8 of the “Notes to Consolidated Financial Statements” included in our Annual Report on Form 10-K for the year ended December 31, 2016 , we filed a patent infringement lawsuit against Par Pharmaceutical, Inc. and its subsidiary, Par Sterile Products, LLC (collectively, Par) in September 2015 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 April 2016, August 2016 and November 2016, we amended the lawsuit to assert additional OMIDRIA patents. Par has stipulated to infringement of each of the currently asserted patents, and the court entered a partial judgment that Par’s filing of its ANDA constitutes an act of infringement of each of the currently asserted patents, subject to Par’s continued invalidity defenses and any challenge to enforceability. The filing of our suit against Par triggered a 30-month stay of the FDA’s approval of Par’s ANDA, which is expected to remain in effect until late January 2018 absent an earlier decision by the court. A bench trial was held on this matter on July 5-7, 2017. The court is expected to issue a decision prior to expiration of the stay. We believe that the invalidity assertions raised by Par do not have merit and we intend to continue defending our patents vigorously. In May 2017, we received Notice Letters from Sandoz Inc. (Sandoz) and Lupin Ltd. and Lupin Pharmaceuticals, Inc. (collectively, Lupin), respectively, that Sandoz and Lupin had each filed an ANDA containing a Paragraph IV Certification under the Hatch-Waxman Act seeking approval from the FDA to market a generic version of OMIDRIA prior to the expiration of six Orange Book-listed patents covering OMIDRIA. On June 21, 2017, we filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware and a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Sandoz and on June 22, 2017 we filed a patent infringement lawsuit in the U.S. District Court for the District of Delaware and a patent infringement lawsuit in the U.S. District Court for the District of New Jersey against Lupin. The Delaware lawsuits have each been served on Sandoz and Lupin, and the New Jersey complaint has been served on Sandoz. The lawsuits were filed under the Hatch-Waxman Act for Sandoz’s and Lupin’s respective infringement of six Omeros patents: U.S. Patent Nos. 8,173,707, 8,586,633, 9,066,856, 9,278,101, 9,399,040 and 9,486,406, which relate to OMIDRIA and that are listed in the Orange Book. These patents were granted following review by the U.S. Patent and Trademark Office, are presumed to be valid under governing law, and can only be invalidated in federal court with clear and convincing evidence. Under the Hatch-Waxman Act, we were permitted to file suit within 45 days from its receipt of each Notice Letter and thereby trigger a 30-month stay of the FDA’s approval of the respective ANDAs. Each stay is expected to remain in effect until November 2019 while the lawsuits are pending. The assertions raised in Sandoz’s and Lupin’s Paragraph IV Notice Letters are substantially similar to those raised by Par in the above-described patent litigation matter against Par. We believe the assertions in the Sandoz and Lupin Paragraph IV Notice Letters do not have merit, and we intend to vigorously prosecute our infringement claims against each of Sandoz and Lupin. |
Shareholders' Equity
Shareholders' Equity | 6 Months Ended |
Jun. 30, 2017 | |
Equity [Abstract] | |
Shareholders' Equity | Shareholders’ Equity Common Stock For the six months ended June 30, 2017 , we received proceeds of $5.6 million upon the exercise of stock options which resulted in the issuance of 628,470 shares of common stock. For the six months ended June 30, 2016 , we received proceeds of $1.9 million upon the exercise of stock options and warrants which resulted in the issuance of 1,171,775 shares of common stock. We did not sell any shares of our common stock under the ATM Agreement during the three or six months ended June 30, 2017 and sold 64,565 shares at an average price of $11.41 per share and received net proceeds of $724,000 during the same period in 2016. We are currently permitted to sell shares of our common stock having an aggregate offering amount of up to $50.0 million under the ATM Agreement. Warrants In connection with an amendment of the then-outstanding loan agreement with Oxford Finance LLC and East West Bank on May 18, 2016, we issued warrants to purchase an aggregate of 100,602 shares of our common stock. As of June 30, 2017 , these warrants remained outstanding and are exercisable through May 18, 2023 at an exercise price of $9.94 per share. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2017 | |
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 2017 2016 2017 2016 (In thousands) (In thousands) Research and development $ 1,263 $ 1,219 $ 2,737 $ 3,374 Selling, general and administrative 1,869 1,391 3,671 3,657 Total $ 3,132 $ 2,610 $ 6,408 $ 7,031 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 2017 2016 2017 2016 Estimated weighted-average fair value $ 12.25 $ 8.50 $ 8.18 $ 6.93 Weighted-average assumptions Expected volatility 74 % 74 % 74 % 74 % Expected term, in years 6.0 5.8 6.0 5.7 Risk-free interest rate 1.95 % 1.37 % 2.01 % 1.40 % 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, 2016 9,809,374 $ 9.66 Granted 1,668,190 12.37 Exercised (628,470 ) 8.97 Forfeited (514,364 ) 10.80 Balance at June 30, 2017 10,334,730 $ 10.07 6.91 $ 128,131 Vested and expected to vest at June 30, 2017 9,972,946 $ 10.00 6.83 $ 124,321 Exercisable at June 30, 2017 6,830,249 $ 9.18 5.77 $ 90,716 At June 30, 2017 , excluding non-employee stock options, the total estimated compensation expense to be recognized in connection with our unvested options is $22.7 million , and 3,712,515 shares were available to grant. 2017 Omnibus Incentive Compensation Plan - On June 16, 2017, our shareholders approved the Omeros Corporation 2017 Omnibus Incentive Compensation Plan (the 2017 Plan), which provides for the grant of incentive and non-statutory stock options, stock appreciation rights, restricted stock, restricted stock units, performance units, performance shares and other stock and cash awards to employees, directors and consultants and subsidiary corporations’ employees and consultants. The 2017 Plan replaces the Omeros Corporation 2008 Equity Incentive Plan (the 2008 Plan) and as a result we will not grant any new awards under the 2008 Plan. Any stock option awards granted under the 2008 Plan that were outstanding as of the effectiveness of the 2017 Plan remain in effect pursuant to their terms and, if the award terminates or is repurchased, the shares underlying such award become available for grant under the 2017 Plan. Under the 2017 Plan, stock options must be granted with exercise prices not less than the fair market value of the common stock subject to the stock option on the date of the grant (and, in some cases, not less than 110% of such fair market value). The term of stock options granted under the 2017 Plan may not exceed 10 years and, in some cases, may not exceed five years. |
Organization and Significant 16
Organization and Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2017 | |
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, 2017 and for the three and six months ended June 30, 2017 and 2016 includes all adjustments, which include normal recurring adjustments, necessary to present fairly our interim financial information. The Condensed Consolidated Balance Sheet at December 31, 2016 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, 2016 , which was filed with the U.S. Securities and Exchange Commission (SEC) on March 16, 2017. |
Product Sales, Net | Product Sales, Net We record revenue from product sales when the product is delivered to our wholesalers. Product sales to a wholesaler are not recorded if we determine that the wholesaler’s on-hand OMIDRIA inventory, based on sell-through and inventory information we regularly receive from our wholesalers, exceeds approximately eight weeks of projected demand. Product sales are recorded net of wholesaler distribution fees and estimated chargebacks, product returns, rebates and purchase volume discounts. Accruals or allowances are established for these deductions in the same period when revenue is recognized, and actual amounts incurred are offset against the applicable accruals or allowances. We reflect each of these accruals or allowances as either a reduction in the related account receivable or as an accrued liability, depending on how the amount is expected to be settled. |
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 | Recent Accounting Pronouncements In May 2014, the Financial Accounting Standards Board, (FASB), issued amended guidance related to revenue from contracts with customers. The amended guidance introduces a new principles-based framework for revenue recognition and disclosure. Since its issuance FASB has issued five Accounting Standards Updates, (ASUs), amending the guidance and effective date, and the SEC has rescinded certain related guidance; the most recent of which was issued in December 2016. The effective date of the guidance requires us to adopt the standard at the beginning of our first quarter of fiscal 2018 with earlier application permitted. The new guidance requires either a modified retrospective method or a full retrospective method of transition. We currently anticipate adopting the guidance at the beginning of our first quarter of fiscal 2018 under the modified retrospective method. We currently do not anticipate a material impact on our revenue recognition practices. We continue to review variable consideration, potential disclosures, and our method of adoption to complete our evaluation of the impact on our consolidated financial statements. In addition, we continue to monitor additional changes, modifications, clarifications or interpretations undertaken by the FASB, which may impact our current conclusions. In February 2016, the 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 method 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 May 2016, the FASB issued ASU 2017-09, Compensation - Stock Compensation (Topic 718), which effectively amends previous issued guidance and provides clarity and consistency in practice on the accounting for changes to the terms and conditions of stock-based payment arrangement. This standard is effective for all annual and interim periods beginning after December 15, 2017 and is applied prospectively to modifications occurring after the adoption date. Earlier adoption is permitted. We do not anticipate a material change upon adoption. |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
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, 2017 2016 Outstanding options to purchase common stock 10,334,730 9,501,818 Outstanding warrants to purchase common stock 100,602 100,602 Total 10,435,332 9,602,420 |
Fair-Value Measurements (Tables
Fair-Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
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, 2017 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted cash and investments $ 5,835 $ — $ — $ 5,835 Money-market funds classified as short-term investments 26,281 — — 26,281 Total $ 32,116 $ — $ — $ 32,116 December 31, 2016 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted cash and investments $ 5,835 $ — $ — $ 5,835 Money-market funds classified as short-term investments 43,107 — — 43,107 Total $ 48,942 $ — $ — $ 48,942 |
Inventory (Tables)
Inventory (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Inventory Disclosure [Abstract] | |
Schedule of Inventory, Current | The components of inventory are as follows: June 30, December 31, (In thousands) Raw materials $ 101 $ 101 Work-in-process 537 854 Finished goods 267 173 Total inventory $ 905 $ 1,128 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued liabilities consist of the following: June 30, December 31, (In thousands) Employee compensation and related taxes $ 5,147 $ 4,551 Contract research and development 4,541 3,030 Consulting and professional fees 4,484 2,223 Sales rebates and discounts 3,767 1,335 Clinical trials 964 1,167 Other accruals 2,740 946 Total accrued liabilities $ 21,643 $ 13,252 |
Notes Payable (Tables)
Notes Payable (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
Debt Disclosure [Abstract] | |
Schedule of notes payable and lease financing obligations | Notes payable and lease financing obligations consist of the following: June 30, December 31, 2016 (in thousands) Notes payable $ 82,143 $ 80,516 Lender facility fee payable upon maturity 4,107 4,025 Lease financing obligations 561 522 Notes payable, facility fee and lease financing obligations 86,811 85,063 Unamortized debt discount (3,755 ) (3,958 ) Unamortized debt issuance costs (1,295 ) (1,395 ) Current portion of lease financing obligations (250 ) (198 ) Non-current portion of notes payable and lease financing obligations, net $ 81,511 $ 79,512 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2017 | |
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 2017 2016 2017 2016 (In thousands) (In thousands) Research and development $ 1,263 $ 1,219 $ 2,737 $ 3,374 Selling, general and administrative 1,869 1,391 3,671 3,657 Total $ 3,132 $ 2,610 $ 6,408 $ 7,031 |
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 2017 2016 2017 2016 Estimated weighted-average fair value $ 12.25 $ 8.50 $ 8.18 $ 6.93 Weighted-average assumptions Expected volatility 74 % 74 % 74 % 74 % Expected term, in years 6.0 5.8 6.0 5.7 Risk-free interest rate 1.95 % 1.37 % 2.01 % 1.40 % 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, 2016 9,809,374 $ 9.66 Granted 1,668,190 12.37 Exercised (628,470 ) 8.97 Forfeited (514,364 ) 10.80 Balance at June 30, 2017 10,334,730 $ 10.07 6.91 $ 128,131 Vested and expected to vest at June 30, 2017 9,972,946 $ 10.00 6.83 $ 124,321 Exercisable at June 30, 2017 6,830,249 $ 9.18 5.77 $ 90,716 |
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, 2017 | Jun. 30, 2016 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Outstanding dilutive securities not included in diluted loss per share calculation | 10,435,332 | 9,602,420 |
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 | 10,334,730 | 9,501,818 |
Outstanding 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 | 100,602 |
Organization and Significant 24
Organization and Significant Accounting Policies (Detail) $ in Thousands | 3 Months Ended | 6 Months Ended | 12 Months Ended | |||||||
Jun. 30, 2017USD ($) | Jun. 30, 2016USD ($) | Jun. 30, 2017USD ($) | Jun. 30, 2016USD ($) | Dec. 31, 2016USD ($)segment | Dec. 31, 2018USD ($) | Aug. 08, 2018USD ($) | Dec. 31, 2017USD ($) | May 10, 2017USD ($) | Nov. 30, 2016USD ($) | |
Debt Instrument [Line Items] | ||||||||||
Number of operating segments | segment | 1 | |||||||||
Net loss | $ 14,359 | $ 12,612 | $ 29,448 | $ 33,151 | $ 66,700 | |||||
Net cash used in operating activities | 20,861 | $ 29,423 | $ (51,500) | |||||||
Cash, cash equivalents and short-term investments | $ 29,700 | $ 29,700 | ||||||||
CRG Loan | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Additional borrowing capacity, tranche one | $ 25,000 | $ 25,000 | ||||||||
Additional borrowing capacity, tranche two | 20,000 | |||||||||
Debt instrument, covenant compliance, product sales revenues required over consecutive 3 month period, tranche two | 25,000 | |||||||||
Debt instrument, covenant compliance, average market capitalization, tranche two | $ 1,000,000 | |||||||||
Scenario, Forecast | CRG Loan | ||||||||||
Debt Instrument [Line Items] | ||||||||||
Debt instrument, covenant compliance, minimum net revenue amount | $ 65,000 | $ 6,800 | $ 55,000 |
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, 2017 | Dec. 31, 2016 |
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total | $ 32,116 | $ 48,942 |
Restricted Cash, Noncurrent | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 5,835 | 5,835 |
Short-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 26,281 | 43,107 |
Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total | 32,116 | 48,942 |
Level 1 | Restricted Cash, Noncurrent | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 5,835 | 5,835 |
Level 1 | Short-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 26,281 | 43,107 |
Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total | 0 | 0 |
Level 2 | Restricted Cash, Noncurrent | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 0 | 0 |
Level 2 | Short-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 0 | 0 |
Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total | 0 | 0 |
Level 3 | Restricted Cash, Noncurrent | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 0 | 0 |
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, 2017 | Dec. 31, 2016 | |
Fair Value Disclosures [Abstract] | ||
Cash excluded from fair value hierarchy disclosure | $ 3,400,000 | $ 2,200,000 |
Unrealized gain (loss) on investments | $ 0 | $ 0 |
Inventory (Details)
Inventory (Details) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Inventory Disclosure [Abstract] | ||
Raw materials | $ 101 | $ 101 |
Work-in-process | 537 | 854 |
Finished goods | 267 | 173 |
Inventory | $ 905 | $ 1,128 |
Accrued Liabilities - Accrued L
Accrued Liabilities - Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Payables and Accruals [Abstract] | ||
Employee compensation and related taxes | $ 5,147 | $ 4,551 |
Contract research and development | 4,541 | 3,030 |
Consulting and professional fees | 4,484 | 2,223 |
Sales rebates and discounts | 3,767 | 1,335 |
Clinical trials | 964 | 1,167 |
Other accruals | 2,740 | 946 |
Total accrued liabilities | $ 21,643 | $ 13,252 |
Notes Payable Schedule of Notes
Notes Payable Schedule of Notes Payable and Lease Financing Obligations (Details) - USD ($) $ in Thousands | Jun. 30, 2017 | Dec. 31, 2016 |
Debt Disclosure [Abstract] | ||
Notes payable | $ 82,143 | $ 80,516 |
Lender facility fee payable upon maturity | 4,107 | 4,025 |
Lease financing obligations | 561 | 522 |
Notes payable, facility fee and lease financing obligations | 86,811 | 85,063 |
Unamortized debt discount | (3,755) | (3,958) |
Unamortized debt issuance costs | (1,295) | (1,395) |
Current portion of lease financing obligations | (250) | (198) |
Non-current portion of notes payable and lease financing obligations, net | $ 81,511 | $ 79,512 |
Notes Payable (Detail)
Notes Payable (Detail) - CRG Loan | 3 Months Ended | 6 Months Ended | |||||
Jun. 30, 2017USD ($) | Jun. 30, 2017USD ($) | Dec. 31, 2018USD ($) | Aug. 08, 2018USD ($) | Dec. 31, 2017USD ($) | May 10, 2017USD ($) | Nov. 30, 2016USD ($) | |
Debt Instrument [Line Items] | |||||||
Debt issued | $ 80,000,000 | ||||||
Additional borrowing capacity, tranche one | $ 25,000,000 | 25,000,000 | |||||
Additional borrowing capacity, tranche two | 20,000,000 | ||||||
Debt instrument, covenant compliance, product sales revenues required over consecutive 3 month period, tranche two | 25,000,000 | ||||||
Debt instrument, covenant compliance, average market capitalization, tranche two | $ 1,000,000,000 | ||||||
Accrued interest rate | 12.25% | ||||||
Deferred interest rate percentage | 4.00% | ||||||
Increase in principal amount of debt outstanding from deferred interest | $ 2,100,000 | $ 1,600,000 | |||||
Debt instrument, covenant compliance, minimum restricted cash and cash equivalents | $ 5,000,000 | ||||||
Maturity fee, as a percent | 5.00% | ||||||
Debt instrument, covenant compliance, minimum market capitalization threshold multiplier | 6.4 | ||||||
Increase in interest rate if an event of default occurs | 4.00% | ||||||
Scenario, Forecast | |||||||
Debt Instrument [Line Items] | |||||||
Debt instrument, covenant compliance, minimum net revenue amount | $ 65,000,000 | $ 6,800,000 | $ 55,000,000 |
Commitments and Contingencies (
Commitments and Contingencies (Details) $ in Millions | May 10, 2017patent | Jun. 30, 2017USD ($) | Dec. 31, 2016patent |
Commitments and Contingencies Disclosure [Abstract] | |||
Contract termination fees | $ | $ 3.7 | ||
Patents allegedly infringed | 3 | ||
Patents expired | 6 |
Shareholders' Equity (Detail)
Shareholders' Equity (Detail) - USD ($) | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | May 18, 2016 | |
Class of Stock [Line Items] | |||
Proceeds upon exercise of stock options and warrants | $ 5,637,000 | $ 1,877,000 | |
Stock issued from exercise of stock options and warrants (in shares) | 628,470 | 1,171,775 | |
Proceeds from issuance of common stock and pre-funded warrants | $ 0 | $ 724,000 | |
At The Market (ATM) Program | |||
Class of Stock [Line Items] | |||
Stock issued during period | 64,565 | ||
Share price (in USD per share) | $ 11.41 | ||
Proceeds from issuance of common stock and pre-funded warrants | $ 724,000 | ||
Aggregate offering price for ATM program | $ 50,000,000 | ||
Oxford EWB Loan | |||
Class of Stock [Line Items] | |||
Shares of common stock to purchase by warrant (in shares) | 100,602 | ||
Warrant exercise price (in USD per share) | $ 9.94 |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Detail) $ in Millions | Jun. 30, 2017USD ($)shares |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Unrecognized compensation expense | $ | $ 22.7 |
Shares available for future grants | shares | 3,712,515 |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total | $ 3,132 | $ 2,610 | $ 6,408 | $ 7,031 |
Research and Development Expense | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 1,263 | 1,219 | 2,737 | 3,374 |
Selling, General and Administrative Expenses | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 1,869 | $ 1,391 | $ 3,671 | $ 3,657 |
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, 2017 | Jun. 30, 2016 | Jun. 30, 2017 | Jun. 30, 2016 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||||
Estimated weighted-average fair value (USD per share) | $ 12.25 | $ 8.50 | $ 8.18 | $ 6.93 |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||||
Expected volatility | 74.00% | 74.00% | 74.00% | 74.00% |
Weighted Average | ||||
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||||
Expected term, in years | 6 years | 5 years 9 months 18 days | 6 years | 5 years 8 months 12 days |
Risk-free interest rate | 1.95% | 1.37% | 2.01% | 1.40% |
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, 2017USD ($)$ / sharesshares | |
Options Outstanding | |
Beginning balance (shares) | shares | 9,809,374 |
Granted (shares) | shares | 1,668,190 |
Exercised (shares) | shares | (628,470) |
Forfeited (shares) | shares | (514,364) |
Ending balance (shares) | shares | 10,334,730 |
Vested and expected to vest (shares) | shares | 9,972,946 |
Exercisable (shares) | shares | 6,830,249 |
Weighted-Average Exercise Price per Share | |
Beginning balance (USD per share) | $ / shares | $ 9.66 |
Granted (USD per share) | $ / shares | 12.37 |
Exercised (USD per share) | $ / shares | 8.97 |
Forfeited (USD per share) | $ / shares | 10.80 |
Ending balance (USD per share) | $ / shares | 10.07 |
Vested and expected to vest (USD per share) | $ / shares | 10 |
Exercisable (USD per share) | $ / shares | $ 9.18 |
Weighted- Average Remaining Contractual Life | |
Balance (in years) | 6 years 10 months 27 days |
Vested and expected to vest (in years) | 6 years 9 months 29 days |
Exercisable (in years) | 5 years 9 months 7 days |
Aggregate Intrinsic Value | |
Balance | $ | $ 128,131 |
Vested and expected to vest | $ | 124,321 |
Exercisable | $ | $ 90,716 |