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 September 30, 2015 and for the three and nine months ended September 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 chargebacks 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 Chargebacks and Rebates. We have 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 chargeback 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 chargeback information and projected payer mix, we record estimated chargebacks 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. On October 15, 2015, we announced the launch of the OMIDRIAssure Reimbursement Services Program whereby we expect to expand broadly patient access to Omidria by providing reimbursement support services, free product based on the financial need of government-insured or uninsured patients and financial assistance for patients whose commercial insurance is inadequate to cover fully the cost of Omidria . 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 is obligated to manufacture and commercialize OMS103 in the U.S. and to 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 September 30, 2015, will be recognized as revenue if and when Fagron sells the product. 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 September 30, 2015 , we had $35.0 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 products or 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 additional capital as and when needed, or upon acceptable terms, such failure would have a significant negative impact on our financial condition. Should it be necessary to manage our operating expenses, we would reduce our projected capital requirements through reduction of our expenses by delaying clinical trials, reducing selected research and development efforts, or implementing other restructuring activities during the next 12 months. 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 September 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 is not expected to 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. As amended, 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. |