Document and Entity Information
Document and Entity Information - shares | 6 Months Ended | |
Jun. 30, 2015 | Aug. 05, 2015 | |
Document Information [Line Items] | ||
Document Type | 10-Q | |
Amendment Flag | false | |
Document Period End Date | Jun. 30, 2015 | |
Document Fiscal Year Focus | 2,015 | |
Document Fiscal Period Focus | Q2 | |
Trading Symbol | 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 | 37,885,698 |
CONSOLIDATED BALANCE SHEETS
CONSOLIDATED BALANCE SHEETS - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Current assets: | ||
Cash and cash equivalents | $ 2,561 | $ 354 |
Short-term investments | 48,885 | 6,532 |
Receivables | 3,071 | 392 |
Inventory | 633 | 568 |
Prepaid expense | 1,423 | 1,191 |
Other current assets | 108 | 120 |
Total current assets | 56,681 | 9,157 |
Property and equipment, net | 789 | 782 |
Restricted cash | 679 | 679 |
Other assets | 488 | 472 |
Total assets | 58,637 | 11,090 |
Current liabilities: | ||
Accounts payable | 4,045 | 4,915 |
Accrued expenses | 6,757 | 7,070 |
Current portion of notes payable, net of discount | 9,294 | 6,446 |
Total current liabilities | 20,096 | 18,431 |
Notes payable, net of current portion and discount | 21,477 | 26,263 |
Deferred rent | $ 9,132 | $ 9,050 |
Commitments and contingencies (Note 7) | ||
Shareholders’ equity: | ||
Preferred stock, par value $0.01 per share: Authorized shares - 20,000,000 at June 30, 2015 (unaudited) and December 31, 2014; Issued and outstanding shares—none | $ 0 | $ 0 |
Common stock, par value $0.01 per share: Authorized shares - 150,000,000 at June 30, 2015 (unaudited) and December 31, 2014; Issued and outstanding shares—37,875,933 and 34,185,464 at June 30, 2015 (unaudited) and December 31, 2014, respectively | 379 | 342 |
Additional paid-in capital | 370,948 | 285,050 |
Accumulated deficit | (363,395) | (328,046) |
Total shareholders’ equity (deficit) | 7,932 | (42,654) |
Total liabilities and shareholders’ equity | $ 58,637 | $ 11,090 |
CONSOLIDATED BALANCE SHEETS (Pa
CONSOLIDATED BALANCE SHEETS (Parenthetical) - $ / shares | Jun. 30, 2015 | Dec. 31, 2014 |
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 | 37,875,933 | 34,185,464 |
Common stock, outstanding shares | 37,875,933 | 34,185,464 |
CONSOLIDATED STATEMENTS OF OPER
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Product sales, net | $ 3,125 | $ 0 | $ 3,363 | $ 0 |
Grant revenue | 62 | 45 | 212 | 145 |
Revenue | 3,187 | 45 | 3,575 | 145 |
Costs and expenses: | ||||
Cost of product sales | 365 | 0 | 376 | 0 |
Research and development | 10,900 | 12,407 | 20,218 | 24,424 |
Selling, general and administrative | 7,889 | 4,855 | 16,878 | 8,622 |
Total costs and expenses | 19,154 | 17,262 | 37,472 | 33,046 |
Loss from operations | (15,967) | (17,217) | (33,897) | (32,901) |
Interest expense | (937) | (939) | (1,894) | (1,611) |
Investment income and other income (expense), net | 224 | 165 | 442 | (121) |
Net loss | (16,680) | (17,991) | (35,349) | (34,633) |
Comprehensive loss | $ (16,680) | $ (17,991) | $ (35,349) | $ (34,633) |
Basic and diluted net loss per share (USD per share) | $ (0.44) | $ (0.53) | $ (0.95) | $ (1.07) |
Weighted-average shares used to compute basic and diluted net loss per share (shares) | 37,846,832 | 33,933,356 | 37,165,196 | 32,415,198 |
CONSOLIDATED STATEMENTS OF CASH
CONSOLIDATED STATEMENTS OF CASH FLOWS - USD ($) $ in Thousands | 6 Months Ended | |
Jun. 30, 2015 | Jun. 30, 2014 | |
Operating activities: | ||
Net loss | $ (35,349) | $ (34,633) |
Adjustments to reconcile net loss to net cash used in operating activities: | ||
Gain on sale of assets | 0 | (9) |
Depreciation and amortization | 107 | 164 |
Stock-based compensation expense | 4,898 | 3,417 |
Non-cash interest expense | 442 | 331 |
Warrant modification expense | 0 | 452 |
Changes in operating assets and liabilities: | ||
Receivables | (2,679) | 127 |
Prepaid expenses and other current and noncurrent assets | (293) | (1,064) |
Accounts payable, accrued expenses and other | (1,229) | 4,279 |
Deferred rent | 82 | 525 |
Net cash used in operating activities | (34,021) | (26,411) |
Investing activities: | ||
Purchases of property and equipment, net | (114) | (2) |
Purchases of investments | (79,403) | (58,844) |
Proceeds from the sale and maturities of investments | 37,050 | 35,634 |
Net cash used in investing activities | (42,467) | (23,212) |
Financing activities: | ||
Proceeds from issuance of common stock and pre-funded warrants, net of offering costs | 79,076 | 37,754 |
Net proceeds from borrowings under notes payable | 0 | 12,699 |
Payments on notes payable | (2,342) | (1,464) |
Proceeds upon exercise of stock options and warrants | 1,961 | 783 |
Net cash provided by financing activities | 78,695 | 49,772 |
Net increase in cash and cash equivalents | 2,207 | 149 |
Cash and cash equivalents at beginning of period | 354 | 1,384 |
Cash and cash equivalents at end of period | 2,561 | 1,533 |
Supplemental cash flow information | ||
Cash paid for interest | 1,471 | 1,188 |
Prepaid expenses not yet paid | $ 68 | $ 0 |
Organization and Significant Ac
Organization and Significant Accounting Policies | 6 Months Ended |
Jun. 30, 2015 | |
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 has been approved by the United States (U.S.) Food and Drug Administration (FDA) for use during cataract surgery or intraocular lens (IOL) replacement. We commenced a controlled launch of Omidria to a small number of ambulatory surgery centers (ASCs) in the U.S. in February 2015. In April 2015, we initiated the broad U.S. launch of Omidria and began selling Omidria through wholesalers. Basis of Presentation Our condensed consolidated financial statements include the financial position and results of operations of Omeros Corporation and our wholly owned subsidiaries. All inter-company transactions have been eliminated. 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, 2015 and for the three and six months ended June 30, 2015 and 2014 includes all adjustments, which include normal recurring adjustments, necessary to present fairly our interim financial information. The Condensed Consolidated Balance Sheet at December 31, 2014 has been derived from our audited financial statements but does not include all of the information and footnotes required by GAAP. The accompanying unaudited condensed consolidated financial statements and notes to condensed consolidated financial statements 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, 2014 filed with the U.S. Securities and Exchange Commission (SEC) on March 16, 2015. Revenue Recognition Our revenues are comprised of product sales of Omidria and amounts earned for services under grants from the National Institutes of Health (NIH). Revenue is recognized when there is persuasive evidence that an arrangement exists, product title and risk of loss is passed to the customer or the service has been provided, the price is fixed or determinable and collection is reasonably assured. We record Omidria product revenue upon delivery to our wholesalers or upon shipment to the ASC or hospital for direct sales. Product sales to a wholesaler are not recorded if we determine that the wholesaler’s on-hand Omidria inventory, based on inventory information we regularly receive from our wholesalers, exceeds approximately eight weeks of projected demand. Product sales are recorded net of estimated charge-backs and rebates, distribution fees and estimated product returns utilizing a variety of information including our historical and projected payer mix, our historical experience as well as industry averages, sale-through and inventory on hand information received directly from wholesalers, changes in the overall marketplace, and the remaining shelf life of product we have previously sold. Accruals are established for these deductions when revenue is recognized, and actual amounts incurred are offset against the applicable accruals. We reflect each of these accruals as either a reduction in the related account receivable or as an accrued liability, depending on how the accrual is settled. Product Sales, Net Charge-backs and Rebates. During the second quarter of 2015, we entered into a Pharmaceutical Pricing Agreement with the Secretary of the U.S. Department of Health and Human Services, which enables entities that qualify for government pricing under the Public Health Services Act (PHSA) to receive discounts on their qualified purchases of Omidria. We have also entered into a Federal Supply Schedule (FSS) agreement under which certain U.S. government purchasers receive a discount on eligible purchases of Omidria. Under these agreements, our wholesalers forward a charge-back to us for the difference between wholesale acquisition cost (WAC) and the applicable discounted price. We identify the entities that purchase Omidria and which are eligible for FSS or PHSA pricing and, utilizing our historical charge-back information and projected payer mix, we record estimated charge-backs for these entities at the time of sale. We have entered into a Medicaid Drug Rebate Agreement with the Centers for Medicare & Medicaid Services (CMS), which provides a rebate to participating states based on covered purchases of Omidria. We record estimated Medicaid rebates based on our payer mix and historical information for Omidria at the time of sale. Distribution Fees and Product Returns. We pay our wholesalers a distribution fee for services they perform for us based on the dollar value of their purchases of Omidria. We record a provision against product sales for these charges at the time of sale to the wholesaler. For all wholesalers, we allow for the return of product up to 12 months past its expiration date or for product that is damaged. In estimating product returns, we take into consideration our single-tier distribution model, our expectation that product is typically not held by the healthcare providers based on the frequency of their reorders, inventory in the wholesale channel, our return experience to date and historical industry return rates. License Agreement Revenues We have entered into an exclusive licensing agreement for OMS103 with Fagron Compounding Services, LLC, d/b/a Fagron Sterile Services and JCB Laboratories, LLC (collectively, Fagron). Under the terms of the license agreement, Fagron will manufacture and commercialize OMS103 in the U.S. and will pay Omeros royalties generated from sales of licensed products related to OMS103 plus milestone payments on reaching certain aggregate sales thresholds. Royalty revenues, of which there were none as of June 30, 2015, will be recognized as revenue when Fagron reports its relevant product sales to us. Aggregate revenue milestones will be recognized as revenue if and when the related sales threshold is achieved. 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, 2015 , we had $51.4 million in cash, cash equivalents and short-term investments. We believe that our existing cash, cash equivalents and short-term investments and revenues, together with capital that we may have the opportunity to raise through public or private equity securities sales, through the issuance of additional debt, through corporate partnerships, through asset sales or through the pursuit of collaborations and licensing arrangements related to certain of our programs will be sufficient to fund our anticipated operating expenses, capital expenditures and interest and principal payments on our outstanding notes for at least the next 12 months. If we are unable to raise capital as and when needed, or upon acceptable terms, such failure would have a significant negative impact on our financial condition. Inventory Inventory is stated at the lower of cost or market determined on a specific identification basis in a manner which approximates the first-in, first-out (FIFO) method. Costs include amounts related to third-party manufacturing, transportation, internal labor and overhead. Capitalization of costs as inventory begins when the product candidate receives regulatory approval in the U.S. or the European Union (EU), which for Omidria began upon U.S. regulatory approval in May 2014. We expense inventory costs related to product candidates as research and development expenses prior to receiving regulatory approval in the respective territory. Inventory is reduced to net realizable value by reserving for excess and obsolete inventories based on forecasted demand. As of June 30, 2015 , all inventory is finished goods for Omidria. Segments We operate in one segment. Management uses cash flow as the primary measure to manage our business and does not segment our business for internal reporting or decision-making. Recent Accounting Pronouncements In July 2015, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2015-11 related to simplifying the measurement of inventory. This standard requires inventory to be measured at the lower of cost or net realizable value. This standard must be applied prospectively and is effective for all annual and interim periods beginning after December 15, 2016. Earlier application is permitted as of the beginning of an interim or annual reporting period. This standard will not have a material impact on the presentation of the Company’s financial position. In April 2015, the FASB issued 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. This standard is effective for interim and annual periods beginning after December 15, 2015 and early adoption is permitted. We are currently evaluating in which period we will transition and the presentation of the debt liability on our balance sheet following such transition, as well as how related disclosures will be impacted. The disclosures required are those applicable for a change in accounting principle. In August 2014, the 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. The standard establishes certain required disclosures if substantial doubt exists. This standard must be applied prospectively and is effective for interim and annual periods beginning after December 15, 2016. We will review the impact of the standard upon our disclosures, if applicable, beginning in 2017. In May 2014, the FASB issued ASU No. 2014-09 related to the recognition of revenue that supersedes existing guidance. This standard clarifies the principles for recognizing revenue utilizing a five-step process. This standard 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. The standard is effective for interim and annual periods beginning after December 15, 2017 and cannot be adopted before that effective date. We are currently evaluating the impact that this standard may have on our financial statements once it is adopted. |
Net Loss Per Share
Net Loss Per Share | 6 Months Ended |
Jun. 30, 2015 | |
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, 2015 and 2014 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, 2015 2014 Outstanding options to purchase common stock 8,427,501 6,814,963 Warrants and pre-funded warrants to purchase common stock 1,149,249 609,016 Total 9,576,750 7,423,979 |
Cash, Cash Equivalents and Inve
Cash, Cash Equivalents and Investments | 6 Months Ended |
Jun. 30, 2015 | |
Cash and Cash Equivalents [Abstract] | |
Cash, Cash Equivalents and Investments | Cash, Cash Equivalents and Investments As of June 30, 2015 and December 31, 2014 , 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, 2015 or December 31, 2014 . Investment income consists primarily of interest earned. |
Fair-Value Measurements
Fair-Value Measurements | 6 Months Ended |
Jun. 30, 2015 | |
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, 2015 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted cash $ 679 $ — $ — $ 679 Money-market funds classified as short-term investments 48,885 — — 48,885 Total $ 49,564 $ — $ — $ 49,564 December 31, 2014 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted cash $ 679 $ — $ — $ 679 Money-market funds classified as short-term investments 6,532 — — 6,532 Total $ 7,211 $ — $ — $ 7,211 Cash held in demand deposit accounts of $2.6 million and $354,000 is excluded from our fair-value hierarchy disclosure as of June 30, 2015 and December 31, 2014 , respectively. There were no unrealized gains and losses associated with our short-term investments as of June 30, 2015 or December 31, 2014 . 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. |
Accrued Liabilities
Accrued Liabilities | 6 Months Ended |
Jun. 30, 2015 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued Liabilities Accrued liabilities consisted of the following: June 30, December 31, (In thousands) Employee compensation $ 2,095 $ 2,421 Contract research 1,636 1,280 Consulting and professional fees 1,600 1,952 Clinical trials 630 828 Other accruals 796 589 Total accrued liabilities $ 6,757 $ 7,070 |
Notes Payable
Notes Payable | 6 Months Ended |
Jun. 30, 2015 | |
Debt Disclosure [Abstract] | |
Notes Payable | Notes Payable In March 2014, we entered into a Loan and Security Agreement (the Oxford/MidCap Loan Agreement) with Oxford Finance LLC (Oxford) and MidCap Financial SBIC, LP (MidCap) pursuant to which we borrowed $32.0 million of which $29.7 million is outstanding as of June 30, 2015 . We used approximately $19.1 million of the loan proceeds to repay all of the amounts owed by us under our then outstanding loan from Oxford and, after deducting loan initiation costs, we received $12.7 million in net proceeds. The Oxford/MidCap Loan Agreement provided for interest-only payments at an annual rate of 9.25% through March 1, 2015 . Beginning April 1, 2015 , monthly principal and interest payments of $1.0 million are due through the maturity date of March 1, 2018 . In addition, the Oxford/MidCap Loan Agreement requires payment of a $2.2 million loan maturity fee upon full repayment of the loan. We may prepay the outstanding principal balance in its entirety at any time if we pay an additional fee equal to 1.0% of the then-outstanding principal balance, which would be waived if we refinance the indebtedness with Oxford and MidCap and pay the loan maturity fee. As security under the Oxford/MidCap Loan Agreement, we granted Oxford, as collateral agent for the lenders, a security interest in substantially all of our assets, excluding intellectual property. The Oxford/MidCap Loan Agreement contains covenants that limit or restrict our ability to enter into certain transactions, and it also includes provisions related to events of default, the occurrence of a material adverse effect (MAE) and changes of control. The occurrence of an event of default could result in the acceleration of the Oxford/MidCap Loan Agreement and, under certain circumstances, could increase our interest rate by 5.0% per annum during the period of default. As of June 30, 2015 , the remaining unamortized discount and debt issuance costs associated with the debt were $1.3 million and $196,000 , respectively, and are being amortized to interest expense using the effective interest method through the loan maturity date. |
Commitments and Contingencies
Commitments and Contingencies | 6 Months Ended |
Jun. 30, 2015 | |
Commitments and Contingencies Disclosure [Abstract] | |
Commitments and Contingencies | Commitments and Contingencies Real Estate Obligations We lease office and laboratory spaces in The Omeros Building. The initial term of the lease ends in November 2027 and we have two options to extend the lease term, each by five years . As of June 30, 2015 , the remaining aggregate non-cancelable rent payable under the initial term of the lease was approximately $56.5 million . The deferred rent balance relates to rent deferrals since the inception of our lease and is being amortized to research and development as well as selling, general and administrative expense on a straight-line basis through the initial term of the lease. Contracts We have an agreement with Ventiv Commercial Services, LLC (inVentiv) for field sales representatives and related sales operation services for Omidria in the U.S. We can terminate the agreement upon 30 days written notice if Omidria is withdrawn from the market for any reason or a regulatory agency acts to prevent or materially restrict the sale of Omidria, or upon 90 days written notice at any time subsequent to January 2016 . As of June 30, 2015 , our commitment under the agreement is approximately $ 630,000 per month through January 2016 and $315,000 per month thereafter through June 2016. We have a non-exclusive agreement with Patheon Manufacturing Services LLC (Patheon) for commercial supply of Omidria through December 31, 2015. Pursuant to the terms of the contract, we are required to provide a monthly, non-binding production forecast covering the term of the contract. Upon submission of the monthly forecast, a portion of the forecast becomes a firm purchase commitment. In the event we do not purchase the quantities included in the firm purchase commitment, we would owe a cancellation fee. As of June 30, 2015 , we had a firm purchase commitment requiring payment of approximately $230,000 . In October 2014, we entered into a non-exclusive agreement with Hospira S.p.A and Hospira Worldwide, Inc. (together, Hospira) for commercial supply of Omidria. We have no firm purchase commitments under this agreement until, in connection with the commencement of commercial manufacturing of Omidria by Hospira, we provide monthly rolling forecasts that will be used to calculate our firm purchase commitment. We have not commenced commercial manufacturing of Omidria by Hospira as of June 30, 2015 and, therefore, we do not currently have any firm purchase commitments outstanding under this agreement. 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 potentially owe certain development milestones and sales-based royalties on commercial sales of certain product candidates within our pipeline. These are low single-digit royalties based on net sales or net income as more fully described in our 2014 Annual Report on Form 10-K filed with the SEC on March 16, 2015. Hatch-Waxman Filing On July 27, 2015, we received notice from Par Pharmaceuticals, Inc. and its subsidiary, Par Sterile Products, LLC (Par) that Par has filed an Abbreviated New Drug Application 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 three patents listed in the Approved Drug Products with Therapeutic Equivalence Evaluations published by the FDA, or Orange Book. We are currently reviewing the details of Par’s notice letter. |
Shareholders' Equity
Shareholders' Equity | 6 Months Ended |
Jun. 30, 2015 | |
Equity [Abstract] | |
Shareholders' Equity | Shareholders’ Equity Common Stock In February 2015, we sold 3.4 million shares of our common stock at a public offering price of $20.03 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. If not exercised, the pre-funded warrants will expire on February 3, 2022. After deducting underwriter discounts and offering expenses of $4.9 million , we received net proceeds from the offering of $79.1 million . In March 2014, we sold 3.5 million shares of our common stock at a public offering price of $11.50 per share. After deducting offering expenses and underwriter discounts of $2.5 million , we received net proceeds from the transaction of $37.8 million . Warrants The following table summarizes our total outstanding warrants as of June 30, 2015 , which have a weighted average exercise price of $10.45 : Outstanding At Expiration Date Exercise Price ($) 133,333 October 21, 2015 20.00 133,333 October 21, 2015 30.00 133,333 October 21, 2015 40.00 749,250 February 3, 2022 0.01 1,149,249 In each of March 2014 and September 2014, we extended the expiration dates of warrants to purchase approximately 197,000 shares of our common stock at an exercise price of $12.25 per share by six months that, collectively, extended the final expiration date of these warrants to March 29, 2015. We evaluated the fair value of the warrants before and after each modification and for the three months ended March 31, 2014, we recorded the $452,000 change in fair value as other expense in the accompanying Condensed Consolidated Statement of Operations and Comprehensive Loss. Prior to the March 29, 2015 expiration date, we received proceeds of $1.4 million during the six months ended June 30, 2015 upon the exercise of approximately 136,000 of these warrants. |
Stock-Based Compensation
Stock-Based Compensation | 6 Months Ended |
Jun. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Stock-Based Compensation | Stock-Based Compensation On January 1, 2015, in accordance with provisions of our 2008 Equity Incentive Plan, the authorized shares available for grant were increased by 1,709,273 shares. As of June 30, 2015 , a total of 10,200,180 shares were reserved for issuance under our stock plans, of which 1,772,679 were available for future grants. 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 2015 2014 2015 2014 Estimated weighted-average fair value $ 12.63 $ 8.20 $ 12.97 $ 8.20 Weighted-average assumptions Expected volatility 69 % 80 % 70 % 80 % Expected term, in years 5.9 5.9 5.9 5.9 Risk-free interest rate 1.71 % 1.88 % 1.61 % 1.88 % Expected dividend yield — % — % — % — % 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 2015 2014 2015 2014 (In thousands) (In thousands) Research and development $ 1,229 $ 901 $ 2,554 $ 1,911 Selling, general and administrative 1,151 729 2,344 1,506 Total $ 2,380 $ 1,630 $ 4,898 $ 3,417 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, 2014 8,364,469 $ 7.52 Granted 218,325 20.74 Exercised (112,398 ) 4.66 Forfeited (42,895 ) 13.52 Balance at June 30, 2015 8,427,501 $ 7.87 6.60 $ 85,881 Vested and expected to vest at June 30, 2015 8,161,248 $ 7.74 6.53 $ 84,159 Exercisable at June 30, 2015 5,774,601 $ 6.16 5.59 $ 68,300 At June 30, 2015 , there were 2,652,900 unvested options outstanding that will vest over a weighted-average period of 2.3 years. Excluding non-employee stock options, the total estimated compensation expense to be recognized in connection with these options is $16.4 million . |
Organization and Significant 15
Organization and Significant Accounting Policies (Policies) | 6 Months Ended |
Jun. 30, 2015 | |
Basis of Presentation | Basis of Presentation Our condensed consolidated financial statements include the financial position and results of operations of Omeros Corporation and our wholly owned subsidiaries. All inter-company transactions have been eliminated. 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, 2015 and for the three and six months ended June 30, 2015 and 2014 includes all adjustments, which include normal recurring adjustments, necessary to present fairly our interim financial information. The Condensed Consolidated Balance Sheet at December 31, 2014 has been derived from our audited financial statements but does not include all of the information and footnotes required by GAAP. The accompanying unaudited condensed consolidated financial statements and notes to condensed consolidated financial statements 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, 2014 filed with the U.S. Securities and Exchange Commission (SEC) on March 16, 2015. |
Revenue Recognition | Revenue Recognition Our revenues are comprised of product sales of Omidria and amounts earned for services under grants from the National Institutes of Health (NIH). Revenue is recognized when there is persuasive evidence that an arrangement exists, product title and risk of loss is passed to the customer or the service has been provided, the price is fixed or determinable and collection is reasonably assured. We record Omidria product revenue upon delivery to our wholesalers or upon shipment to the ASC or hospital for direct sales. Product sales to a wholesaler are not recorded if we determine that the wholesaler’s on-hand Omidria inventory, based on inventory information we regularly receive from our wholesalers, exceeds approximately eight weeks of projected demand. Product sales are recorded net of estimated charge-backs and rebates, distribution fees and estimated product returns utilizing a variety of information including our historical and projected payer mix, our historical experience as well as industry averages, sale-through and inventory on hand information received directly from wholesalers, changes in the overall marketplace, and the remaining shelf life of product we have previously sold. Accruals are established for these deductions when revenue is recognized, and actual amounts incurred are offset against the applicable accruals. We reflect each of these accruals as either a reduction in the related account receivable or as an accrued liability, depending on how the accrual is settled. |
Revenue Recognition, Product Sales, Net | Product Sales, Net Charge-backs and Rebates. During the second quarter of 2015, we entered into a Pharmaceutical Pricing Agreement with the Secretary of the U.S. Department of Health and Human Services, which enables entities that qualify for government pricing under the Public Health Services Act (PHSA) to receive discounts on their qualified purchases of Omidria. We have also entered into a Federal Supply Schedule (FSS) agreement under which certain U.S. government purchasers receive a discount on eligible purchases of Omidria. Under these agreements, our wholesalers forward a charge-back to us for the difference between wholesale acquisition cost (WAC) and the applicable discounted price. We identify the entities that purchase Omidria and which are eligible for FSS or PHSA pricing and, utilizing our historical charge-back information and projected payer mix, we record estimated charge-backs for these entities at the time of sale. We have entered into a Medicaid Drug Rebate Agreement with the Centers for Medicare & Medicaid Services (CMS), which provides a rebate to participating states based on covered purchases of Omidria. We record estimated Medicaid rebates based on our payer mix and historical information for Omidria at the time of sale. Distribution Fees and Product Returns. We pay our wholesalers a distribution fee for services they perform for us based on the dollar value of their purchases of Omidria. We record a provision against product sales for these charges at the time of sale to the wholesaler. For all wholesalers, we allow for the return of product up to 12 months past its expiration date or for product that is damaged. In estimating product returns, we take into consideration our single-tier distribution model, our expectation that product is typically not held by the healthcare providers based on the frequency of their reorders, inventory in the wholesale channel, our return experience to date and historical industry return rates. |
Revenue Recognition, License Agreement Revenues | License Agreement Revenues We have entered into an exclusive licensing agreement for OMS103 with Fagron Compounding Services, LLC, d/b/a Fagron Sterile Services and JCB Laboratories, LLC (collectively, Fagron). Under the terms of the license agreement, Fagron will manufacture and commercialize OMS103 in the U.S. and will pay Omeros royalties generated from sales of licensed products related to OMS103 plus milestone payments on reaching certain aggregate sales thresholds. Royalty revenues, of which there were none as of June 30, 2015, will be recognized as revenue when Fagron reports its relevant product sales to us. Aggregate revenue milestones will be recognized as revenue if and when the related sales threshold is achieved. |
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. |
Inventory, Policy | Inventory Inventory is stated at the lower of cost or market determined on a specific identification basis in a manner which approximates the first-in, first-out (FIFO) method. Costs include amounts related to third-party manufacturing, transportation, internal labor and overhead. Capitalization of costs as inventory begins when the product candidate receives regulatory approval in the U.S. or the European Union (EU), which for Omidria began upon U.S. regulatory approval in May 2014. We expense inventory costs related to product candidates as research and development expenses prior to receiving regulatory approval in the respective territory. Inventory is reduced to net realizable value by reserving for excess and obsolete inventories based on forecasted demand. As of June 30, 2015 , all inventory is finished goods for Omidria. |
Segments | Segments We operate in one segment. Management uses cash flow as the primary measure to manage our business and does not segment our business for internal reporting or decision-making. |
Recent Accounting Pronouncements | Recent Accounting Pronouncements In July 2015, the Financial Accounting Standards Board (FASB) issued Accounting Standards Update (ASU) 2015-11 related to simplifying the measurement of inventory. This standard requires inventory to be measured at the lower of cost or net realizable value. This standard must be applied prospectively and is effective for all annual and interim periods beginning after December 15, 2016. Earlier application is permitted as of the beginning of an interim or annual reporting period. This standard will not have a material impact on the presentation of the Company’s financial position. In April 2015, the FASB issued 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. This standard is effective for interim and annual periods beginning after December 15, 2015 and early adoption is permitted. We are currently evaluating in which period we will transition and the presentation of the debt liability on our balance sheet following such transition, as well as how related disclosures will be impacted. The disclosures required are those applicable for a change in accounting principle. In August 2014, the 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. The standard establishes certain required disclosures if substantial doubt exists. This standard must be applied prospectively and is effective for interim and annual periods beginning after December 15, 2016. We will review the impact of the standard upon our disclosures, if applicable, beginning in 2017. In May 2014, the FASB issued ASU No. 2014-09 related to the recognition of revenue that supersedes existing guidance. This standard clarifies the principles for recognizing revenue utilizing a five-step process. This standard 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. The standard is effective for interim and annual periods beginning after December 15, 2017 and cannot be adopted before that effective date. We are currently evaluating the impact that this standard may have on our financial statements once it is adopted. |
Net Loss Per Share (Tables)
Net Loss Per Share (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
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, 2015 2014 Outstanding options to purchase common stock 8,427,501 6,814,963 Warrants and pre-funded warrants to purchase common stock 1,149,249 609,016 Total 9,576,750 7,423,979 |
Fair-Value Measurements (Tables
Fair-Value Measurements (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
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, 2015 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted cash $ 679 $ — $ — $ 679 Money-market funds classified as short-term investments 48,885 — — 48,885 Total $ 49,564 $ — $ — $ 49,564 December 31, 2014 Level 1 Level 2 Level 3 Total (In thousands) Assets: Money-market funds classified as non-current restricted cash $ 679 $ — $ — $ 679 Money-market funds classified as short-term investments 6,532 — — 6,532 Total $ 7,211 $ — $ — $ 7,211 |
Accrued Liabilities (Tables)
Accrued Liabilities (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Payables and Accruals [Abstract] | |
Accrued Liabilities | Accrued liabilities consisted of the following: June 30, December 31, (In thousands) Employee compensation $ 2,095 $ 2,421 Contract research 1,636 1,280 Consulting and professional fees 1,600 1,952 Clinical trials 630 828 Other accruals 796 589 Total accrued liabilities $ 6,757 $ 7,070 |
Shareholders' Equity (Tables)
Shareholders' Equity (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Equity [Abstract] | |
Schedule of Stockholders' Equity Note, Warrants or Rights | The following table summarizes our total outstanding warrants as of June 30, 2015 , which have a weighted average exercise price of $10.45 : Outstanding At Expiration Date Exercise Price ($) 133,333 October 21, 2015 20.00 133,333 October 21, 2015 30.00 133,333 October 21, 2015 40.00 749,250 February 3, 2022 0.01 1,149,249 |
Stock-Based Compensation (Table
Stock-Based Compensation (Tables) | 6 Months Ended |
Jun. 30, 2015 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | |
Schedule of Share-based Payment Award, Stock Options, Valuation Assumptions [Table Text Block] | The following assumptions were applied to employee and director stock option grants during the periods ended: Three Months Ended Six Months Ended 2015 2014 2015 2014 Estimated weighted-average fair value $ 12.63 $ 8.20 $ 12.97 $ 8.20 Weighted-average assumptions Expected volatility 69 % 80 % 70 % 80 % Expected term, in years 5.9 5.9 5.9 5.9 Risk-free interest rate 1.71 % 1.88 % 1.61 % 1.88 % Expected dividend yield — % — % — % — % |
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 2015 2014 2015 2014 (In thousands) (In thousands) Research and development $ 1,229 $ 901 $ 2,554 $ 1,911 Selling, general and administrative 1,151 729 2,344 1,506 Total $ 2,380 $ 1,630 $ 4,898 $ 3,417 |
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, 2014 8,364,469 $ 7.52 Granted 218,325 20.74 Exercised (112,398 ) 4.66 Forfeited (42,895 ) 13.52 Balance at June 30, 2015 8,427,501 $ 7.87 6.60 $ 85,881 Vested and expected to vest at June 30, 2015 8,161,248 $ 7.74 6.53 $ 84,159 Exercisable at June 30, 2015 5,774,601 $ 6.16 5.59 $ 68,300 |
Organization and Significant 21
Organization and Significant Accounting Policies (Detail) - Jun. 30, 2015 $ in Millions | USD ($)segment |
Accounting Policies [Abstract] | |
Cash, Cash Equivalents, and Short-term Investments | $ | $ 51.4 |
Number of operating segments | 1 |
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, 2015 | Jun. 30, 2014 | |
Antidilutive Securities Excluded from Computation of Earnings Per Share [Line Items] | ||
Outstanding dilutive securities not included in diluted loss per share calculation | 9,576,750 | 7,423,979 |
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 | 8,427,501 | 6,814,963 |
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 | 1,149,249 | 609,016 |
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, 2015 | Dec. 31, 2014 |
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total | $ 49,564 | $ 7,211 |
Fair Value, Inputs, Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total | 49,564 | 7,211 |
Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total | 0 | 0 |
Fair Value, Inputs, Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Total | 0 | 0 |
Restricted Cash, Noncurrent | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 679 | 679 |
Restricted Cash, Noncurrent | Fair Value, Inputs, Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 679 | 679 |
Restricted Cash, Noncurrent | Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 0 | 0 |
Restricted Cash, Noncurrent | Fair Value, Inputs, Level 3 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 0 | 0 |
Short-term Investments | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 48,885 | 6,532 |
Short-term Investments | Fair Value, Inputs, Level 1 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 48,885 | 6,532 |
Short-term Investments | Fair Value, Inputs, Level 2 | ||
Fair Value, Assets and Liabilities Measured on Recurring Basis [Line Items] | ||
Money-market funds, fair value disclosure | 0 | 0 |
Short-term Investments | Fair Value, Inputs, Level 3 | ||
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, 2015 | Dec. 31, 2014 | |
Fair Value Disclosures [Abstract] | ||
Cash excluded from fair value hierarchy disclosure | $ 2,600,000 | $ 354,000 |
Unrealized gain (loss) on investments | $ 0 | $ 0 |
Accrued Liabilities - Accrued L
Accrued Liabilities - Accrued Liabilities (Detail) - USD ($) $ in Thousands | Jun. 30, 2015 | Dec. 31, 2014 |
Payables and Accruals [Abstract] | ||
Employee compensation | $ 2,095 | $ 2,421 |
Contract research | 1,636 | 1,280 |
Consulting and professional fees | 1,600 | 1,952 |
Clinical trials | 630 | 828 |
Other accruals | 796 | 589 |
Total accrued liabilities | $ 6,757 | $ 7,070 |
Notes Payable (Detail)
Notes Payable (Detail) - USD ($) | 3 Months Ended | 6 Months Ended | ||
Mar. 31, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | Mar. 04, 2014 | |
Debt Instrument [Line Items] | ||||
Net proceeds from borrowings under notes payable | $ 0 | $ 12,699,000 | ||
Oxford Midcap Loan | ||||
Debt Instrument [Line Items] | ||||
Loan and security agreement, existing outstanding indebtedness | $ 29,700,000 | $ 32,000,000 | ||
Repayments of Debt | $ 19,100,000 | |||
Net proceeds from borrowings under notes payable | $ 12,700,000 | |||
Accrued interest rate | 9.25% | |||
Debt Instrument, Date of First Required Payment | Apr. 1, 2015 | |||
Debt Instrument, Periodic Payment | $ 1,021,000 | |||
Debt Instrument, Fee Amount | $ 2,200,000 | |||
Debt Prepayment Penalty Rate | 1.00% | |||
Additional Default Interest Rate | 5.00% | |||
Unamortized balance of debt discount | $ 1,300,000 | |||
Unamortized balance of debt issuance costs | $ 196,000 |
Commitments and Contingencies (
Commitments and Contingencies (Detail) - Jun. 30, 2015 $ in Thousands | USD ($) | USD ($)Leases |
Commitments and Contingencies Disclosure [Line Items] | ||
Number of Options to extend the lease term | Leases | 2 | |
Options to extend the lease term, number of options | 5 years | |
Remaining aggregate rent payable | $ 56,500 | $ 56,500 |
Patheon | ||
Commitments and Contingencies Disclosure [Line Items] | ||
Unrecorded Unconditional Purchase Obligation | 230 | $ 230 |
Purchase Commitment, Through January 2016 | ||
Commitments and Contingencies Disclosure [Line Items] | ||
Monthly purchase commitment | 630 | |
Purchase Commitment, February 2016 Through June 2016 | ||
Commitments and Contingencies Disclosure [Line Items] | ||
Monthly purchase commitment | $ 315 |
Shareholders' Equity (Detail)
Shareholders' Equity (Detail) | 1 Months Ended | 3 Months Ended | 6 Months Ended | |||
Feb. 28, 2015USD ($)$ / sharesshares | Mar. 31, 2014USD ($)$ / sharesshares | Mar. 31, 2014USD ($)$ / sharesshares | Jun. 30, 2015USD ($)$ / shares$ / Rightshares | Jun. 30, 2014USD ($) | Sep. 30, 2014$ / sharesshares | |
Class of Stock [Line Items] | ||||||
Stock issued during period | 3,400,000 | 3,500,000 | ||||
Shares of common stock to purchase by warrant | 749,250 | 197,000 | 197,000 | 197,000 | ||
Share Price | $ / shares | $ 20.03 | $ 11.50 | $ 11.50 | |||
Exercise price of warrants | $ / shares | $ 0.01 | $ 12.25 | $ 12.25 | $ 12.25 | ||
Payments of Stock Issuance Costs | $ | $ 4,900,000 | $ 2,500,000 | ||||
Proceeds from issuance of common stock and pre-funded warrants, net of offering costs | $ | $ 79,100,000 | $ 37,800,000 | $ 79,076,000 | $ 37,754,000 | ||
Class of Warrant or Right, Exercise Price of Warrants or Rights, Weighted Average Price | $ / Right | 10.45 | |||||
Class of Warrant or Right, Outstanding | 1,149,249 | |||||
Proceeds from Warrant Exercises | $ | $ 1,400,000 | |||||
Class of Warrant or Right, Exercised During Period | 136,000 | |||||
Warrant One | Vulcan Incorporated | ||||||
Class of Stock [Line Items] | ||||||
Shares of common stock to purchase by warrant | 133,333 | |||||
Exercise price of warrants | $ / shares | $ 20 | |||||
Warrant expiration date | Oct. 21, 2015 | |||||
Warrant Two | Vulcan Incorporated | ||||||
Class of Stock [Line Items] | ||||||
Shares of common stock to purchase by warrant | 133,333 | |||||
Exercise price of warrants | $ / shares | $ 30 | |||||
Warrant expiration date | Oct. 21, 2015 | |||||
Warrant Three | Vulcan Incorporated | ||||||
Class of Stock [Line Items] | ||||||
Shares of common stock to purchase by warrant | 133,333 | |||||
Exercise price of warrants | $ / shares | $ 40 | |||||
Warrant expiration date | Oct. 21, 2015 | |||||
Pre-funded Warrants | ||||||
Class of Stock [Line Items] | ||||||
Shares of common stock to purchase by warrant | 749,250 | |||||
Share Price | $ / shares | $ 20.02 | |||||
Exercise price of warrants | $ / shares | $ 0.01 | |||||
Warrant expiration date | Feb. 3, 2022 | |||||
Series E Mod 1Q14 | ||||||
Class of Stock [Line Items] | ||||||
Fair Value Adjustment of Warrants | $ | $ (452,000) |
Stock-Based Compensation - Narr
Stock-Based Compensation - Narrative (Detail) - USD ($) $ in Millions | 1 Months Ended | 6 Months Ended |
Jan. 31, 2015 | Jun. 30, 2015 | |
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Unvested options outstanding | 2,652,900 | |
Unvested options outstanding, vesting period | 2 years 3 months 28 days | |
Unrecognized compensation expense | $ 16.4 | |
Equity Incentive Plan 2008 | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Stock options, number of shares reserved for issuance | 10,200,180 | |
Share-based Compensation Arrangement by Share-based Payment Award, Number of Shares Available for Grant | 1,772,679 | |
Equity Incentive Plan 2008 | Stock Option | ||
Share-based Compensation Arrangement by Share-based Payment Award [Line Items] | ||
Increase in authorized shares | 1,709,273 |
Stock-Based Compensation - Fair
Stock-Based Compensation - Fair Value of Employee Option Grant Estimated on Date of Grant (Details) - $ / shares | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Disclosure of Compensation Related Costs, Share-based Payments [Abstract] | ||||
Estimated weighted-average fair value (USD per share) | $ 12.63 | $ 8.20 | $ 12.97 | $ 8.20 |
Share-based Compensation Arrangement by Share-based Payment Award, Fair Value Assumptions and Methodology [Abstract] | ||||
Expected volatility | 69.00% | 80.00% | 70.00% | 80.00% |
Expected term, in years | 5 years 10 months 24 days | 5 years 11 months 8 days | 5 years 11 months 8 days | 5 years 11 months 8 days |
Risk-free interest rate | 1.71% | 1.88% | 1.61% | 1.88% |
Expected dividend yield | 0.00% | 0.00% | 0.00% | 0.00% |
Stock-Based Compensation - Stoc
Stock-Based Compensation - Stock-Based Compensation Expense (Detail) - USD ($) $ in Thousands | 3 Months Ended | 6 Months Ended | ||
Jun. 30, 2015 | Jun. 30, 2014 | Jun. 30, 2015 | Jun. 30, 2014 | |
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Total | $ 2,380 | $ 1,630 | $ 4,898 | $ 3,417 |
Research and Development Expense | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | 1,229 | 901 | 2,554 | 1,911 |
Selling, General and Administrative Expenses | ||||
Employee Service Share-based Compensation, Allocation of Recognized Period Costs [Line Items] | ||||
Stock-based compensation expense | $ 1,151 | $ 729 | $ 2,344 | $ 1,506 |
Stock-Based Compensation - Summ
Stock-Based Compensation - Summary of Stock Option Activity and Related Information (Detail) - Jun. 30, 2015 - USD ($) $ / shares in Units, $ in Thousands | Total |
Options Outstanding | |
Beginning balance (shares) | 8,364,469 |
Granted (shares) | 218,325 |
Exercised (shares) | (112,398) |
Forfeited (shares) | (42,895) |
Ending balance (shares) | 8,427,501 |
Vested and expected to vest (shares) | 8,161,248 |
Exercisable (shares) | 5,774,601 |
Weighted-Average Exercise Price per Share | |
Beginning balance (USD per share) | $ 7.52 |
Granted (USD per share) | 20.74 |
Exercised (USD per share) | 4.66 |
Forfeited (USD per share) | 13.52 |
Ending balance (USD per share) | 7.87 |
Vested and expected to vest (USD per share) | 7.74 |
Exercisable (USD per share) | $ 6.16 |
Weighted- Average Remaining Contractual Life | |
Balance (in years) | 6 years 7 months 5 days |
Vested and expected to vest (in years) | 6 years 6 months 10 days |
Exercisable (in years) | 5 years 7 months 2 days |
Aggregate Intrinsic Value | |
Balance | $ 85,881 |
Vested and expected to vest | 84,159 |
Exercisable | $ 68,300 |