Organization and Significant Accounting Policies | 3 Months Ended |
Mar. 31, 2014 |
Organization and Significant Accounting Policies | ' |
Organization and Significant Accounting Policies |
Organization |
We are a clinical-stage biopharmaceutical company committed to discovering, developing and commercializing products targeting inflammation, coagulopathies and disorders of the central nervous system. Our most clinically advanced potential product, OMS302 or Omidria™ for lens replacement surgery, is derived from our proprietary PharmacoSurgery® platform designed to improve clinical outcomes of patients undergoing ophthalmological, arthroscopic, urological and other surgical procedures. Our PharmacoSurgery platform is based on low-dose combinations of therapeutic agents delivered directly to the surgical site throughout the duration of the procedure to inhibit preemptively inflammation and other problems caused by surgical trauma and to provide clinical benefits both during and after surgery. In addition to Omidria, we have six other clinical-stage development programs in our pipeline, which also includes a diverse group of preclinical programs as well as two additional platforms: one capable of unlocking new G protein-coupled receptor (GPCR) drug targets and the other used to generate antibodies. For each of our programs and potential products, which we refer to herein as products, we have retained all manufacturing, marketing and distribution rights. |
Omidria is being developed for use in patients undergoing intraocular lens replacement surgery. In July 2013, we submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) and in September 2013, we submitted a Marketing Authorisation Application (MAA) to the European Medicines Agency (EMA) for Omidria. We expect the FDA to approve our NDA for Omidria in the second quarter of 2014. Assuming approval, we expect to begin marketing Omidria in the U.S. in the second half of 2014. In the European Union (EU) and other international territories, we plan to enter into one or more partnerships for the marketing and distribution of Omidria. |
Basis of Presentation |
Our consolidated financial statements include the financial position and results of operations of Omeros Corporation (Omeros) and our wholly owned subsidiaries. All inter-company transactions between and among our subsidiaries have been eliminated. The accompanying unaudited 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 March 31, 2014 and for the three months ended March 31, 2014 and 2013 includes all adjustments, which include normal recurring adjustments, necessary to present fairly our interim financial information. The Consolidated Balance Sheet at December 31, 2013 has been derived from audited financial statements but does not include all of the information and footnotes required by GAAP. |
The accompanying unaudited consolidated financial statements and notes to 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, 2013 filed with the Securities and Exchange Commission (SEC) on March 13, 2014. |
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 March 31, 2014, we had $52.2 million in cash, cash equivalents and short-term investments due, in part, to our recent receipt of the net amounts of $37.7 million from the sale of our common stock and $12.7 million of additional debt financing. We believe that our existing cash, cash equivalents and short-term investments, together with potential sales from Omidria and capital that we may be able to raise through one or more corporate partnerships, equity offerings, debt financings, collaborations, licensing arrangements or asset sales, will be sufficient to fund our anticipated operating expenses, capital expenditures and note payments for at least the next 12 months. |
Inventory |
Capitalization of costs as inventory will begin when the product has received regulatory approval in either the U.S. or the EU. We expense inventory costs related to products as research and development expenses prior to regulatory approval. |
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. |