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ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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Washington
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91-1663741
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(State or other jurisdiction of
incorporation or organization)
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(I.R.S. Employer
Identification Number)
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201 Elliott Avenue West
Seattle, Washington
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98119
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(Address of principal executive offices)
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(Zip Code)
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Common Stock, $0.01 par value per share
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The NASDAQ Stock Market LLC
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(Title of each class)
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(Name of each exchange on which registered)
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Large accelerated filer
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¨
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Accelerated filer
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x
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Non-accelerated filer
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(Do not check if a smaller reporting company)
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Smaller reporting company
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¨
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our ability to receive regulatory approval for our New Drug Application, or NDA, and our Marketing Authorisation Application, or MAA, for the commercialization of OMS302, or Omidria
™
, in the United States and in the European Union, or EU, respectively, in 2014;
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our anticipation that we will begin marketing Omidria, if approved, in the U.S. in the second half of 2014, and that we will initiate marketing Omidria, if approved, in the EU in late 2014 or the first half of 2015;
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our ability to successfully complete our Phase 2 clinical trials for OMS824 and our Phase 1 clinical trial for OMS721;
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our ability to initiate post-marketing studies for Omidria and additional clinical trials for OMS103;
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our ability to initiate a Phase 2 clinical trial for OMS721;
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our expectations regarding the clinical, therapeutic and competitive benefits of our potential products, which we refer to as products;
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whether there may be an opportunity to have our PharmacoSurgery
®
products produced and commercialized by a registered outsourcing facility, and whether any additional trials may need to be conducted;
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our estimate regarding how long our existing cash, cash equivalents and short-term investments will be sufficient to fund our anticipated operating expenses, capital expenditures and note payments;
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our ability to raise additional capital through the capital markets or one or more corporate partnerships, equity offerings, debt financings, collaboration and licensing arrangements or asset sales;
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our expectation that the second half of 2014 is the earliest period in which any of our products will be commercially available or generate revenue;
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our anticipation that we will rely on contract manufacturers to develop and manufacture our products for commercial sale and will out-license Omidria marketing rights to one or more third-parties in the EU;
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our ability to enter into acceptable arrangements with potential corporate partners;
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our expectation that the clinical benefits of our PharmacoSurgery products could provide surgeons a competitive marketing advantage and facilitate third-party payor acceptance;
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whether pediatric studies may afford Omidria an additional six months of exclusivity;
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our expectation that the intended therapeutic effect of MASP-2 antibodies we develop can be achieved with subcutaneous and other system routes of administration;
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whether the variant KD1 proteins we are developing in our Plasmin program could provide more effective bleeding control with fewer side effects than Trasylol
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, and our expectation that our Plasmin program molecule will compare favorably to Trayslol
®
with respect to safety;
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our ability to obtain commercial supplies of our PharmacoSurgery APIs and products and, if approved, our ability to successfully commercialize our PharmacoSurgery products with a limited marketing and sales force;
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our sales and marketing plans for our products and programs, including Omidria;
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our expectations regarding reimbursement and pricing for Omidria, including our expectation that Omidria will meet the criteria for transitional separate payment;
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our expectations about the commercial competition that our products may face;
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our expected financial position, performance, growth, expenses, the magnitude of our net losses and the availability of resources;
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the extent of protection that our patents provide and our pending patent applications may provide, if patents issue from such applications, to our technologies and programs;
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our involvement in potential claims, legal proceedings and administrative actions, the expected course and costs of potential claims, legal proceedings and administrative actions, and the potential outcomes and effects of potential claims, legal proceedings and administrative actions on our business, prospects, financial condition and results of operations; and
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our estimates regarding our future net losses, revenues, research and development expenses and selling, general and administrative expenses.
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Page
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ITEM 1.
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BUSINESS
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Program
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Targeted
Procedure/Disease
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Development Status
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Next Expected
Milestone
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Worldwide
Rights
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Clinical Programs
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Omidria (OMS302) - Ophthalmology
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Intraocular Lens Replacement Surgery
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NDA/MAA filed
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Potential Approval of NDA and MAA
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Omeros
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OMS103 - Arthroscopy
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Arthroscopic Meniscectomy
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Phase 3
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Redesign Phase 3 Program and Determine Commercialization Path
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Omeros
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PDE10 (OMS824) - CNS Disorders
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Schizophrenia
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Phase 2
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Complete Phase 2 Trial
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Omeros
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PDE10 (OMS824) - CNS Disorders
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Huntington's Disease
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Phase 2
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Complete Phase 2 Trial
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Omeros
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MASP (OMS721) - Complement-Mediated Disorders
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TMA (aHUS, TTP, transplant-related TMA)
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Phase 2
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Initiate Enrollment in Phase 2 Trial
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Omeros (In-licensed)
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PPARγ (OMS405) - Addiction
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Opioid and Nicotine Addiction
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Phase 2
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Complete Phase 2 Trials
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Omeros
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OMS201 - Urology
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Ureteroscopy
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Phase 1/2
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Design Phase 2 Trial and Determine Commercialization Path
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Omeros
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Preclinical Programs
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PDE7 (OMS527)
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Addictions and Compulsive Disorders; Movement Disorders
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Preclinical
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Complete Human Dose-Enabling Toxicology Studies and GMP Manufacturing
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Omeros (Compounds In-licensed)
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Plasmin (OMS616)
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Surgical and Traumatic Bleeding
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Preclinical
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Complete Human Dose-Enabling Toxicology Studies and GMP Manufacturing
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Omeros (In-licensed)
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GPCR Platform
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Multiple Disorders Across Therapeutic Areas
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Preclinical
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Continue Drug Discovery and Selected Medicinal Chemistry for Class A Orphan and Class B GPCRs
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Omeros
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GPR17 - CNS disorders
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Demyelinating Disorders
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Preclinical
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Compound Optimization
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Omeros
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Antibody Platform
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Multiple Disorders Across Therapeutic Areas
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Preclinical
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Continue Developing Antibodies Targeting Alternative Pathway of Complement System and Expanding Antibody Library
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Omeros (In-licensed)
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develop and market products that are less expensive, more effective or safer than our future products;
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commercialize competing products before we can launch our products;
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initiate or withstand substantial price competition more successfully than we can;
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have greater success in recruiting skilled technical and scientific workers from the limited pool of available talent;
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more effectively negotiate third-party licenses and strategic relationships; and
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take advantage of acquisition or other opportunities more readily than we can.
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Omidria-Ophthalmology.
Omidria is encompassed by our PharmacoSurgery patent portfolio. The relevant patents and patent applications in this portfolio are directed to combinations of agents, generic and/or proprietary to us or others, drawn from therapeutic classes such as pain and inflammation inhibitory agents, mydriatic agents and agents that reduce intraocular pressure, delivered locally and intra-operatively to the site of ophthalmological procedures, including cataract and lens replacement surgery. As of February 15, 2014, we owned two issued U.S. Patents and three pending U.S. Patent Applications and 28 issued patents and 11 pending patent applications in foreign markets (Argentina, Australia, Canada, China, Europe, Hong Kong, Japan and International Patent Cooperation Treaty) that are directed to Omidria.
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OMS103-Arthroscopy.
OMS103 is encompassed by our PharmacoSurgery patent portfolio. The relevant patents and patent applications in this portfolio are directed to combinations of agents, generic and/or proprietary to us or others, drawn from therapeutic classes such as pain and inflammation inhibitory agents and vasoconstrictive agents, delivered locally and intra-operatively to the site of medical or surgical procedures, including arthroscopy. As of February 15, 2014, we owned six issued U.S. Patents, three pending U.S. Patent Applications, and 41 issued patents and 17 pending patent applications in foreign markets (Argentina, Australia, Brazil, Canada, Chile, China, Europe, Hong Kong, India, Indonesia, Israel, Japan, Mexico, New Zealand, Norway, Russia, Singapore, South Africa South Korea and International Patent Cooperation Treaty) that are directed to OMS103.
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OMS201-Urology.
OMS201 is encompassed by our PharmacoSurgery patent portfolio. The relevant patents and patent applications in this portfolio are directed to combinations of agents, generic and/or proprietary to us or others, drawn from therapeutic classes such as pain and inflammation inhibitory agents and spasm inhibitory agents, delivered locally and intra-operatively to the site of medical or surgical procedures, including uroendoscopy. As of February 15, 2014, we owned three issued U.S. Patents, two pending U.S. Patent Applications, and an additional 35 issued patents and five pending patent applications in foreign markets (Australia, Brazil, Canada, China, Europe, Hong Kong, India, Japan, Mexico, Norway, Russia, Singapore and South Korea) that are directed to OMS201.
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PDE10 Program - OMS824.
As of February 15, 2014, we own five issued patents and one pending patent application in the U.S., and one issued patent and 23 pending patent applications in foreign markets (Australia, Brazil, Canada, China, Chile, Europe, India, Indonesia, Israel, Japan, Mexico, New Zealand, South Korea and South Africa) that are directed to proprietary PDE10 inhibitors.
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PPARγ Program - OMS405
. As of February 15, 2014, we owned one issued patent and three pending patent applications in the U.S. and seven issued patents and 26 pending patent applications in foreign markets (Australia, Brazil, Canada, China, Europe, India, Japan, Mexico, New Zealand, Russia and South Korea) directed to our recent discoveries linking PPARγ and addictive disorders.
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MASP-2 Program - OMS721.
We hold worldwide exclusive licenses to rights in connection with MASP-2, the antibodies targeting MASP-2 and the therapeutic applications for those antibodies from the University of Leicester, Medical Research Council at Oxford University and Helion. As of February 15, 2014, we exclusively controlled seven issued patents and 17 pending patent applications in the U.S., and 16 issued patents and 90 pending patent applications in foreign markets (Australia, Brazil, Canada, Chile, China, Hong Kong, Europe, India, Indonesia, Israel, Japan, Mexico, New Zealand, Russia, South Africa, South Korea and International Patent Cooperation Treaty) related to our MASP-2 program.
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PDE7 Program - OMS527.
As of February 15, 2014, we owned one issued patent and two pending patent applications in the United Stated, and two issued patents and 23 pending patent applications in foreign markets (Australia, Brazil, Canada, China, Europe, India, Japan, Mexico, New Zealand and Russia) directed to our discoveries linking PDE7 to movement disorders, as well as two issued patents and one pending patent application in the U.S. and 16 pending patent applications in foreign markets (Australia, Brazil, Canada, Chile, China, Europe, India, Indonesia, Israel, Japan, Mexico, New Zealand, Russia, South Africa and South Korea) directed to the link between PDE7 and addiction and compulsive disorders. Additionally, under a license from Daiichi Sankyo we exclusively control rights to two issued U.S. Patents and one pending U.S. Patent Application, and 56 issued and six pending patent applications in foreign markets (Australia, Brazil, Canada, China, Europe, Hong Kong, Hungary,
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Plasmin Program - OMS616.
We hold worldwide exclusive licenses to a series of antifibrinolytic agents from The Regents of the University of California. As of February 15, 2014, we exclusively controlled two issued patents and three pending patent applications in the U.S. and 21 issued and five pending patent applications in foreign markets (Australia, Canada, Europe and Japan) that are directed to these proprietary agents.
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GPCR Platform.
As of February 15, 2014, we owned five issued patents and 10 pending patent applications in the U.S., and 43 issued patents and eight pending patent applications in foreign markets (Australia, Canada, China, Europe, Hong Kong, India, Japan, Macao, Mexico, New Zealand and Russia), which are directed to previously unknown links between specific molecular targets in the brain and a series of CNS disorders, our cellular redistribution assay and other research tools that are used in our GPCR program and to orphan GPCRs and other GPCRs for which we have identified functionally interacting compounds using our cellular redistribution assay.
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Antibody Platform
. As of February 15, 2014, we owned and/or held worldwide exclusive license rights from the University of Washington to three pending U.S. Patent Applications, four foreign patent applications (Australia, Canada, Europe, Japan) and one International Patent Cooperation Treaty Patent Application directed to our antibody platform. Additionally, we owned one issued U.S. Patent, two pending U.S. Patent Applications and eight pending foreign applications (Australia, Canada, Europe, Japan) directed to antibodies generated using our platform.
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PharmacoSurgery Platform.
Our scientific co-founders, Gregory A. Demopulos, M.D. and Pamela Pierce Palmer, M.D., Ph.D., conceived the initial invention underlying our PharmacoSurgery platform and transferred all of their related intellectual property rights to us in 1994. Other than their rights as shareholders, our co-founders have not retained any rights to our PharmacoSurgery platform, except that if we file for liquidation under Chapter 7 of the U.S. Bankruptcy Act or voluntarily liquidate or dissolve, other than in connection with a merger, reorganization, consolidation or sale of assets, our co-founders have the right to repurchase the initial PharmacoSurgery intellectual property at the then-current fair market value. Subsequent developments of the PharmacoSurgery intellectual property were assigned to us by Dr. Demopulos, Dr. Palmer and other of our employees and consultants, without restriction.
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PDE10 and PDE7 Programs.
We acquired our PDE10 and PDE7 programs and some of our related patents and other intellectual property rights as a result of our acquisition of nura, inc. We hold an exclusive license to certain PDE7 inhibitors claimed in patents and pending patent applications owned by Daiichi Sankyo for use in the treatment of movement, addiction and compulsive disorders as well as other specified indications. For a more detailed description of our agreement with Daiichi Sankyo, see "Business-Preclinical Programs-PDE7 Program."
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MASP-2 Program.
We hold worldwide exclusive licenses to rights related to MASP-2, the antibodies targeting MASP-2 and the therapeutic applications for the antibodies from MRC and Helion. For more detailed descriptions of these licenses, see "Business-Clinical Programs-MASP Program."
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PPARγ Program
. We acquired the patent applications and related intellectual property rights for our PPARγ program in 2009 from Roberto Ciccocioppo, Ph.D., of the Università di Camerino, Italy, pursuant to a patent assignment agreement. For a more detailed description of this agreement, see "Business-Clinical Programs- PPARγ Program."
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Plasmin Program.
We hold a worldwide exclusive license to patent rights related to certain antifibrinolytics from The Regents. For a more detailed description of this agreement, see "Business-Preclinical Programs-Plasmin Program."
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GPCR Platform.
We acquired our GPCR program and some of our related patents and other intellectual property rights as a result of our acquisition of nura, inc. In November of 2010 we acquired intellectual property rights related to an assay technology for our GPCR program from Patobios Limited for approximately $10.8 million.
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Antibody Platform
. We hold a worldwide exclusive license to patent rights related to our antibody platform from the University of Washington. For a more detailed description of this agreement, see "Business-Preclinical Programs-Antibody Platform.
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formulation development and manufacturing process development;
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preclinical laboratory and animal testing;
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submission to the FDA of an IND application for human clinical testing, which must become effective before human clinical trials may begin; and in Europe, a CTA is filed according to the country's local regulations;
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adequate and well-controlled human clinical trials to establish the efficacy and safety of the product for each indication for which approval is sought;
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adequate assessment of drug product stability to determine shelf life/expiry dating;
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in Europe, submission to the EMA of an MAA, and in the U.S., submission to the FDA of an NDA, in the case of a drug product, or a biologics license application, or BLA, in the case of a biologic product;
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satisfactory completion of inspections of clinical sites and the manufacturing facility or facilities at which the product is produced to assess compliance with current Good Clinical Practices, or cGCP, and cGMP; and
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FDA review and approval of an NDA or BLA, or EMA approval of an MAA.
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Phase 1 usually involves the initial administration of the investigational product to human subjects, who may or may not have the disease or condition for which the product is being developed, to evaluate the safety, dosage tolerance, pharmacodynamics and, if possible, to gain an early indication of the effectiveness of the product.
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Phase 2 usually involves trials in a limited patient population with the disease or condition for which the product is being developed to evaluate appropriate dosage, to identify possible adverse side effects and safety risks, and to evaluate preliminarily the effectiveness of the product for specific indications.
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Phase 3 clinical trials usually further evaluate and confirm effectiveness and test further for safety by administering the product in its final form in an expanded patient population.
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Name
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Age
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Position(s)
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Executive Officers:
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Gregory A. Demopulos, M.D.
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55
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President, Chief Executive Officer and Chairman of the Board of Directors
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Michael A. Jacobsen
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55
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Vice President, Finance, Chief Accounting Officer and Treasurer
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Marcia S. Kelbon, J.D., M.S.
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54
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Vice President, Patent and General Counsel and Secretary
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Key Employees:
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Timothy M. Duffy
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53
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Vice President, Business Development
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Kenneth M. Ferguson, Ph.D.
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58
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Vice President, Development and Chief Development Officer
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George A. Gaitanaris, M.D., Ph.D.
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57
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Vice President, Science and Chief Scientific Officer
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Patrick W. Gray, Ph.D.
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62
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Scientific Fellow
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Michael K. Inouye
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58
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Vice President, Commercial Operations
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Catherine A. Melfi, Ph.D.
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55
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Vice President, Regulatory Affairs and Quality Systems
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J. Steven Whitaker, M.D., J.D.
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58
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Vice President, Clinical Development and Chief Medical Officer
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Albert S. Yu, M.D.
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57
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Vice President, Clinical Development
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generate commercial sales of our products, if approved, through our own sales force, collaborations with pharmaceutical companies or contract sales organizations, that we may establish;
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establish effective marketing programs and build brand identity;
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obtain acceptance of our products by physicians, patients and third party payors and obtain and maintain distribution of our products;
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establish and maintain agreements with distributors on commercially reasonable terms; and
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demonstrate commercial manufacturing capabilities necessary to meet the commercial demand for a product and maintain commercial manufacturing arrangements with third-party manufacturers.
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our ability to provide acceptable evidence of safety, efficacy and product quality;
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the availability and relative cost and efficacy of alternative and competing treatments;
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the effectiveness of our marketing and distribution strategy to, among others, hospitals, surgery centers, physicians and/or pharmacists;
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the prevalence of the condition for which the product is approved or frequency of the related surgical procedure;
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the acceptance by physicians of each product as a safe and effective treatment;
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the perceived advantages over alternative treatments;
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the relative convenience and ease of administration;
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the availability of adequate reimbursement by Medicare and other third parties;
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the frequency and severity of adverse side effects; and
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publicity concerning our products or competing products and treatments.
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a covered benefit under its health plan;
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safe, effective and medically necessary;
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appropriate for the specific patient;
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cost-effective; and
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neither experimental nor investigational.
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our inability to recruit in a timely manner, and retain, adequate numbers of effective sales and marketing personnel, or to partner or contract with a third party to provide sales and marketing services, in the applicable region of the world, particularly before our planned market launch of Omidria, if approved, in the second half of 2014;
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the inability of sales personnel to sell our product(s) to adequate numbers of hospitals, surgery centers, physicians and/or pharmacists;
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our inability to develop and maintain adequate internal information systems to monitor sales by distribution channel, report pricing, maintain customer lists and track selling and marketing operations;
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the lack of complementary products to be offered by sales personnel, which may put us at a competitive disadvantage relative to companies with more extensive product lines; and
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unforeseen costs and expenses associated with creating an independent sales and marketing organization.
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prepare for the potential commercialization of Omidria;
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continue the Phase 3 clinical program of OMS103 for use in arthroscopic partial meniscectomy surgery;
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continue the clinical development of OMS824 and OMS721;
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continue our development efforts in our GPCR program to advance this program for potential partnering or for internal development of products targeting GPCRs;
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scale-up and produce clinical and commercial supplies of products, and conduct clinical studies for our products, including for Omidria, OMS103, OMS824, OMS721, and products being developed in our PDE7 and Plasmin programs;
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continue research and development in all of our programs;
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make principal and interest payments when due under our debt facility with Oxford and MidCap;
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initiate and conduct clinical trials for other products;
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make milestone payments to our collaborators;
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undertake development activities and make the required payments to maintain our exclusive licenses to our MASP-2 program; and
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launch and commercialize any products for which we receive regulatory approval.
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discussions with the FDA, the EMA or other foreign authorities regarding the scope or design of our clinical trials;
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delays or the inability to obtain required approvals from Institutional Review Boards, Ethics Committees or other responsible entities at clinical sites selected for participation in our clinical trials;
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delays in enrolling patients into clinical trials;
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lower than anticipated retention rates of patients in clinical trials;
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the need to repeat or conduct additional clinical trials as a result of problems such as inconclusive or negative results, poorly executed testing, a failure of a clinical site to adhere to the clinical protocol or an unacceptable study design;
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an insufficient supply of product materials or other materials necessary to conduct our clinical trials;
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the need to qualify new suppliers of product materials for FDA and foreign regulatory approval;
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an unfavorable FDA inspection or review of a clinical trial site or records of any clinical investigation;
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the occurrence of unacceptable drug-related side effects or adverse events experienced by participants in our clinical trials; or
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the placement of a trial on a clinical hold.
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failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
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inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;
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unforeseen safety issues or any determination that a trial presents unacceptable health risks; or
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lack of adequate funding to continue the clinical trial or development program, including the incurrence of unforeseen costs due to enrollment delays, requirements to conduct additional trials and studies and increased expenses associated with the services of our contract research organizations, or CROs, and other third parties.
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the severity of the disease under investigation;
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the design of the trial protocol;
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the size of the patient population;
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the availability of competing therapies and clinical trials;
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the eligibility criteria of the study in question;
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the perceived risks and benefits of the product candidate under study;
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the efforts to facilitate timely enrollment in clinical trials;
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the patient referral practices of physicians;
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the ability to monitor patients adequately before and after treatment; and
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the proximity and availability of clinical trial sites for prospective patients.
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we might not have been the first to make the inventions covered by any of our pending U.S. patent applications filed or having priority dates prior to the U.S. having adopted a first-to-file standard on March 16, 2013, or any U.S. patents issued based on such patent applications;
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we might not have been the first to file patent applications on inventions that are the subject of pending foreign patent applications or that are the subject of pending U.S. patent applications filed or having priority dates after March 16, 2013, or any patents issued based on such foreign or U.S. patent applications;
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others may independently develop similar or alternative technologies or products or duplicate any of our technologies or products;
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we may not be able to generate sufficient data to fully support patent applications that protect the entire breadth of developments expected to result from our development programs, including the GPCR program;
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it is possible that none of our pending patent applications will result in issued patents or, if issued, that these patents will be sufficient to protect our technology or provide us with a basis for commercially viable products or provide us with any competitive advantages;
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if our pending applications issue as patents, they may be challenged by third parties as not infringed, invalid or unenforceable under U.S. or foreign laws;
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if issued, the patents under which we hold rights may not be valid or enforceable; or
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we may develop additional proprietary technologies or products that are not patentable and which are unlikely to be adequately protected through trade secrets if, for example, a competitor were to independently develop duplicative, similar or alternative technologies or products.
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operate larger research and development programs, possess commercial-scale manufacturing operations or have substantially greater financial resources than we do;
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initiate or withstand substantial price competition more successfully than we can;
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have greater success in recruiting skilled technical and scientific workers from the limited pool of available talent;
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more effectively negotiate third-party licenses and strategic relationships; and
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take advantage of acquisition or other opportunities more readily than we can.
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restrictions on such products or manufacturing processes;
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withdrawal of the products from the market;
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voluntary or mandatory recalls;
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fines;
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suspension or withdrawal of regulatory approvals;
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product seizures; or
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injunctions or the imposition of civil or criminal penalties.
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FDA or EMA actions related to our NDA and MAA submissions for Omidria;
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results from our clinical development programs, including the data from our ongoing clinical development programs evaluating Omidria, OMS103, OMS824, OMS721 and OMS405;
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FDA or foreign regulatory actions related to any of our other products;
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announcements regarding the progress of our preclinical programs, including without limitation our GPCR program;
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failure of any of our products, if approved, to achieve commercial success;
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quarterly variations in our results of operations or those of our competitors;
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our ability to develop and market new and enhanced products on a timely basis;
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announcements by us or our competitors of acquisitions, regulatory approvals, clinical milestones, new products, significant contracts, commercial relationships or capital commitments;
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third-party coverage and reimbursement policies;
|
•
|
additions or departures of key personnel;
|
•
|
commencement of, our involvement in and resolution of litigation;
|
•
|
our ability to meet our repayment and other obligations under the Oxford/MidCap Loan Agreement;
|
•
|
the inability of our contract manufacturers to provide us with adequate commercial supplies of our products;
|
•
|
changes in governmental regulations or in the status of our regulatory approvals;
|
•
|
changes in earnings estimates or recommendations by securities analysts;
|
•
|
any major change in our board or management;
|
•
|
general economic conditions and slow or negative growth of our markets; and
|
•
|
political instability, natural disasters, war and/or events of terrorism.
|
ITEM 1B.
|
UNRESOLVED STAFF COMMENTS
|
ITEM 2.
|
PROPERTIES
|
ITEM 4.
|
MINE SAFETY DISCLOSURES
|
ITEM 5.
|
MARKET FOR REGISTRANT'S COMMON EQUITY, RELATED SHAREHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIES
|
Year Ended December 31, 2013
|
|
High
|
|
Low
|
4th Quarter
|
|
$13.76
|
|
$6.92
|
3rd Quarter
|
|
$10.70
|
|
$4.75
|
2nd Quarter
|
|
$5.70
|
|
$3.65
|
1st Quarter
|
|
$6.52
|
|
$3.90
|
|
|
|
|
|
Year Ended December 31, 2012
|
|
High
|
|
Low
|
4th Quarter
|
|
$11.85
|
|
$5.08
|
3rd Quarter
|
|
$10.34
|
|
$8.17
|
2nd Quarter
|
|
$13.45
|
|
$8.51
|
1st Quarter
|
|
$10.88
|
|
$3.96
|
ITEM 6.
|
SELECTED CONSOLIDATED FINANCIAL DATA
|
|
Year Ended December 31,
|
||||||||||||||||||
|
2013
|
|
2012
|
|
2011
|
|
2010
|
|
2009
|
||||||||||
|
(In thousands, except share data)
|
||||||||||||||||||
Consolidated Statements of Operations and Comprehensive Loss Data:
|
|
|
|
|
|
|
|
|
|
||||||||||
Revenue
|
$
|
1,600
|
|
|
$
|
6,022
|
|
|
$
|
4,524
|
|
|
$
|
2,105
|
|
|
$
|
1,444
|
|
Operating expenses:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||||
Research and development
|
36,297
|
|
|
31,922
|
|
|
23,718
|
|
|
23,465
|
|
|
16,929
|
|
|||||
Selling, general and administrative
|
15,819
|
|
|
10,985
|
|
|
8,216
|
|
|
8,746
|
|
|
5,273
|
|
|||||
Total operating expenses
|
52,116
|
|
|
42,907
|
|
|
31,934
|
|
|
32,211
|
|
|
22,202
|
|
|||||
Loss from operations
|
(50,516
|
)
|
|
(36,885
|
)
|
|
(27,410
|
)
|
|
(30,106
|
)
|
|
(20,758
|
)
|
|||||
Litigation settlement
|
12,500
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|
—
|
|
|||||
Investment income
|
12
|
|
|
40
|
|
|
51
|
|
|
167
|
|
|
214
|
|
|||||
Interest expense
|
(2,366
|
)
|
|
(1,729
|
)
|
|
(1,884
|
)
|
|
(1,535
|
)
|
|
(2,202
|
)
|
|||||
Loss on extinguishment of debt
|
—
|
|
|
—
|
|
|
—
|
|
|
(296
|
)
|
|
—
|
|
|||||
Other income (expense), net
|
574
|
|
|
130
|
|
|
697
|
|
|
2,519
|
|
|
1,657
|
|
|||||
Net Loss
|
$
|
(39,796
|
)
|
|
$
|
(38,444
|
)
|
|
$
|
(28,546
|
)
|
|
$
|
(29,251
|
)
|
|
$
|
(21,089
|
)
|
Basic and diluted net loss per share
|
$
|
(1.39
|
)
|
|
$
|
(1.59
|
)
|
|
$
|
(1.29
|
)
|
|
$
|
(1.37
|
)
|
|
$
|
(2.92
|
)
|
Denominator for basic and diluted net loss per share
|
28,560,360
|
|
|
24,155,690
|
|
|
22,212,351
|
|
|
21,420,883
|
|
|
7,218,915
|
|
|
As of December 31,
|
||||||||||||||||||
|
2013
|
|
2012
|
|
2011
|
|
2010
|
|
2009
|
||||||||||
|
(In thousands)
|
||||||||||||||||||
Consolidated Balance Sheet Data:
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|||||
Cash, cash equivalents and short-term investments
|
$
|
14,101
|
|
|
$
|
22,350
|
|
|
$
|
24,570
|
|
|
$
|
41,993
|
|
|
$
|
60,305
|
|
Working capital
|
2,944
|
|
|
16,341
|
|
|
6,963
|
|
|
27,880
|
|
|
49,574
|
|
|||||
Total assets
|
16,535
|
|
|
26,575
|
|
|
26,982
|
|
|
45,704
|
|
|
62,062
|
|
|||||
Notes payable, net of discount
|
20,498
|
|
|
20,103
|
|
|
19,446
|
|
|
10,255
|
|
|
12,758
|
|
|||||
Accumulated deficit
|
(254,373
|
)
|
|
(214,577
|
)
|
|
(176,133
|
)
|
|
(147,587
|
)
|
|
(118,336
|
)
|
|||||
Total shareholders' (deficit) equity
|
(18,384
|
)
|
|
(6,531
|
)
|
|
(5,554
|
)
|
|
20,470
|
|
|
43,145
|
|
|
Years Ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
|
(In thousands)
|
||||||||||
Vulcan Inc.
|
$
|
970
|
|
|
$
|
4,677
|
|
|
$
|
2,000
|
|
Life Science Development Fund Authority (LSDF)
|
—
|
|
|
624
|
|
|
2,028
|
|
|||
Small Business Innovative Research Grant (SBIR)
|
630
|
|
|
721
|
|
|
266
|
|
|||
Other Revenue
|
—
|
|
|
—
|
|
|
230
|
|
|||
Total Revenue
|
$
|
1,600
|
|
|
$
|
6,022
|
|
|
$
|
4,524
|
|
|
Years Ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
|
(In thousands)
|
||||||||||
Direct external expenses:
|
|
|
|
|
|
||||||
Clinical research and development:
|
|
|
|
|
|
||||||
Omidria (OMS302)
|
$
|
4,477
|
|
|
$
|
8,622
|
|
|
$
|
4,663
|
|
OMS721
|
1,996
|
|
|
—
|
|
|
—
|
|
|||
OMS103
|
404
|
|
|
2,773
|
|
|
3,558
|
|
|||
OMS824
|
7,265
|
|
|
990
|
|
|
12
|
|
|||
Other clinical programs
|
35
|
|
|
52
|
|
|
60
|
|
|||
Total clinical research and development
|
14,177
|
|
|
12,437
|
|
|
8,293
|
|
|||
Preclinical research and development
|
4,149
|
|
|
6,019
|
|
|
5,005
|
|
|||
Total direct external expenses
|
18,326
|
|
|
18,456
|
|
|
13,298
|
|
|||
|
|
|
|
|
|
||||||
Internal, overhead and other expenses
|
14,383
|
|
|
11,275
|
|
|
9,601
|
|
|||
Stock-based compensation expense
|
3,588
|
|
|
2,191
|
|
|
819
|
|
|||
Total research and development expenses
|
$
|
36,297
|
|
|
$
|
31,922
|
|
|
$
|
23,718
|
|
|
Years Ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
|
(In thousands)
|
||||||||||
Selling, general and administrative, excluding stock-based compensation expense
|
$
|
13,155
|
|
|
$
|
8,895
|
|
|
$
|
7,108
|
|
Stock-based compensation expense
|
2,664
|
|
|
2,090
|
|
|
1,108
|
|
|||
Total selling, general and administrative expenses
|
$
|
15,819
|
|
|
$
|
10,985
|
|
|
$
|
8,216
|
|
|
Years Ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
|
(In thousands)
|
||||||||||
Interest Expense
|
$
|
2,366
|
|
|
$
|
1,729
|
|
|
$
|
1,884
|
|
|
Years Ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
|
(In thousands)
|
||||||||||
Other Income (Expense), Net
|
$
|
574
|
|
|
$
|
130
|
|
|
$
|
697
|
|
|
Years ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
|
(In thousands)
|
||||||||||
Selected cash flow data:
|
|
|
|
|
|
||||||
Cash provided by (used in):
|
|
|
|
|
|
||||||
Operating activities
|
$
|
(29,695
|
)
|
|
$
|
(34,551
|
)
|
|
$
|
(25,668
|
)
|
Investing activities
|
7,909
|
|
|
(907
|
)
|
|
16,909
|
|
|||
Financing activities
|
21,650
|
|
|
32,973
|
|
|
9,486
|
|
•
|
the progress and results of our preclinical and clinical programs;
|
•
|
the costs of commercialization activities, including product manufacturing, marketing, sales and distribution;
|
•
|
the commercial success of Omidria, if and when Omidria is approved for sale in the U.S. and/or the EU;
|
•
|
the cost, timing and outcomes of the regulatory processes for our products;
|
•
|
the extent to which we raise capital by selling our stock or entering into other forms of financing including debt agreements;
|
•
|
the terms and timing of receipts or payments related to collaborative or licensing agreements we have or may establish;
|
•
|
the hiring of new employees to support our continued growth
|
•
|
the extent to which we acquire or invest in businesses, products or technologies, although we currently have no commitments or agreements relating to these types of transactions; and
|
•
|
the cost of preparing, filing, prosecuting, defending and enforcing patent claims and other intellectual property rights;
|
•
|
revenue recognition;
|
•
|
research and development expenses, primarily clinical trial expenses; and
|
•
|
stock-based compensation.
|
ITEM 9.
|
CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE
|
ITEM 9B.
|
OTHER INFORMATION
|
ITEM 10.
|
DIRECTORS, EXECUTIVE OFFICERS AND CORPORATE GOVERNANCE
|
ITEM 11.
|
EXECUTIVE COMPENSATION
|
ITEM 12.
|
SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREHOLDER MATTERS
|
|
Number of Securities to be
Issued Upon Exercise of
Outstanding Options,
Warrants and Rights
|
|
Weighted-Average
Exercise Price of
Outstanding Options,
Warrants and Rights
|
|
Number of Securities
Remaining Available for
Future Issuance Under
Equity Compensation
Plans
|
||||
Equity compensation plans approved by security holders:
|
|
|
|
|
|
||||
2008 Equity Incentive Plan (1)
|
5,299,298
|
|
|
$
|
7.99
|
|
|
413,330
|
|
Amended and Restated 1998 Stock Option Plan
|
1,669,567
|
|
|
1.25
|
|
|
—
|
|
|
nura, inc. 2003 Stock Option Plan
|
438
|
|
|
10.63
|
|
|
—
|
|
|
Total
|
6,969,303
|
|
|
$
|
6.38
|
|
|
413,330
|
|
ITEM 13.
|
CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE
|
ITEM 14.
|
PRINCIPAL ACCOUNTING FEES AND SERVICES
|
OMEROS CORPORATION
|
/s/ GREGORY A. DEMOPULOS, M.D.
|
Gregory A. Demopulos, M.D.
|
President, Chief Executive Officer
and Chairman of the Board of Directors |
Signature
|
Title
|
Date
|
|
|
|
/s/ GREGORY A. DEMOPULOS, M.D.
|
President, Chief Executive Officer and Chairman of the Board of Directors (Principal Executive Officer)
|
March 13, 2014
|
Gregory A. Demopulos, M.D.
|
|
|
|
|
|
/s/ MICHAEL A. JACOBSEN
|
Vice President, Finance, Chief Accounting Officer and Treasurer (Principal Financial Officer and Principal Accounting Officer)
|
March 13, 2014
|
Michael A. Jacobsen
|
|
|
|
|
|
/s/ RAY ASPIRI
|
Director
|
March 13, 2014
|
Ray Aspiri
|
|
|
|
|
|
/s/ THOMAS J. CABLE
|
Director
|
March 13, 2014
|
Thomas J. Cable
|
|
|
|
|
|
/s/ PETER A. DEMOPULOS, M.D.
|
Director
|
March 13, 2014
|
Peter A. Demopulos, M.D.
|
|
|
|
|
|
/s/ ARNOLD C. HANISH
|
Director
|
March 13, 2014
|
Arnold C. Hanish
|
|
|
|
|
|
/s/ LEROY E. HOOD, M.D., PH.D.
|
Director
|
March 13, 2014
|
Leroy E. Hood, M.D., Ph.D.
|
|
|
|
|
|
Page
|
REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM
|
F-2
|
CONSOLIDATED BALANCE SHEETS
|
F-3
|
CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
|
F-4
|
CONSOLIDATED STATEMENT OF SHAREHOLDERS' EQUITY (DEFICIT)
|
F-5
|
CONSOLIDATED STATEMENTS OF CASH FLOWS
|
F-6
|
NOTES TO CONSOLIDATED FINANCIAL STATEMENTS
|
F-7
|
|
December 31,
|
||||||
|
2013
|
|
2012
|
||||
Assets
|
|
|
|
||||
Current assets:
|
|
|
|
||||
Cash and cash equivalents
|
$
|
1,384
|
|
|
$
|
1,520
|
|
Short-term investments
|
12,717
|
|
|
20,830
|
|
||
Grant and other receivables
|
379
|
|
|
1,934
|
|
||
Prepaid expenses and other current assets
|
337
|
|
|
416
|
|
||
Total current assets
|
14,817
|
|
|
24,700
|
|
||
Property and equipment, net
|
939
|
|
|
1,037
|
|
||
Restricted cash
|
679
|
|
|
679
|
|
||
Other assets
|
100
|
|
|
159
|
|
||
Total assets
|
$
|
16,535
|
|
|
$
|
26,575
|
|
Liabilities and shareholders’ equity
|
|
|
|
||||
Current liabilities:
|
|
|
|
||||
Accounts payable
|
$
|
2,329
|
|
|
$
|
2,632
|
|
Accrued expenses
|
3,944
|
|
|
4,757
|
|
||
Deferred revenue
|
—
|
|
|
970
|
|
||
Current portion of notes payable, net of discount
|
5,600
|
|
|
—
|
|
||
Total current liabilities
|
11,873
|
|
|
8,359
|
|
||
Notes payable, net of current portion and discount
|
14,898
|
|
|
20,103
|
|
||
Deferred rent
|
8,148
|
|
|
4,644
|
|
||
Commitments and contingencies (Note 8)
|
|
|
|
||||
Shareholders' equity:
|
|
|
|
||||
Preferred stock, par value $0.01 per share:
|
|
|
|
||||
Authorized shares—20,000,000 at December 31, 2013 and 2012;
|
|
|
|
||||
Issued and outstanding shares—none
|
—
|
|
|
—
|
|
||
Common stock, par value $0.01 per share:
|
|
|
|
||||
Authorized shares—150,000,000 at December 31, 2013 and 2012;
|
|
|
|
||||
Issued and outstanding shares—30,359,508 and 25,897,483 at December 31, 2013 and 2012, respectively
|
304
|
|
|
259
|
|
||
Additional paid-in capital
|
235,685
|
|
|
207,787
|
|
||
Accumulated deficit
|
(254,373
|
)
|
|
(214,577
|
)
|
||
Total shareholders' deficit
|
(18,384
|
)
|
|
(6,531
|
)
|
||
Total liabilities and shareholders' equity
|
$
|
16,535
|
|
|
$
|
26,575
|
|
|
Year Ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
Revenue
|
$
|
1,600
|
|
|
$
|
6,022
|
|
|
$
|
4,524
|
|
Operating expenses:
|
|
|
|
|
|
||||||
Research and development
|
36,297
|
|
|
31,922
|
|
|
23,718
|
|
|||
Selling, general and administrative
|
15,819
|
|
|
10,985
|
|
|
8,216
|
|
|||
Total operating expenses
|
52,116
|
|
|
42,907
|
|
|
31,934
|
|
|||
Loss from operations
|
(50,516
|
)
|
|
(36,885
|
)
|
|
(27,410
|
)
|
|||
Litigation settlement
|
12,500
|
|
|
—
|
|
|
—
|
|
|||
Investment income
|
12
|
|
|
40
|
|
|
51
|
|
|||
Interest expense
|
(2,366
|
)
|
|
(1,729
|
)
|
|
(1,884
|
)
|
|||
Other income (expense), net
|
574
|
|
|
130
|
|
|
697
|
|
|||
Net loss
|
$
|
(39,796
|
)
|
|
$
|
(38,444
|
)
|
|
$
|
(28,546
|
)
|
Comprehensive loss
|
$
|
(39,796
|
)
|
|
$
|
(38,444
|
)
|
|
$
|
(28,546
|
)
|
Basic and diluted net loss per share
|
$
|
(1.39
|
)
|
|
$
|
(1.59
|
)
|
|
$
|
(1.29
|
)
|
Weighted-average shares used to compute basic and diluted net loss per share
|
28,560,360
|
|
|
24,155,690
|
|
|
22,212,351
|
|
|
Common Stock
|
|
Additional
Paid-in Capital |
|
Accumulated
Deficit |
|
Total
Shareholders’ Deficit |
|||||||||||
|
Shares
|
|
Amount
|
|
||||||||||||||
Balance at December 31, 2010
|
21,920,836
|
|
|
$
|
219
|
|
|
$
|
167,838
|
|
|
$
|
(147,587
|
)
|
|
$
|
20,470
|
|
Issuance of common stock upon exercise of stock options for cash
|
509,398
|
|
|
5
|
|
|
590
|
|
|
—
|
|
|
595
|
|
||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
1,927
|
|
|
—
|
|
|
1,927
|
|
||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(28,546
|
)
|
|
(28,546
|
)
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Balance at December 31, 2011
|
22,430,234
|
|
|
224
|
|
|
170,355
|
|
|
(176,133
|
)
|
|
(5,554
|
)
|
||||
Issuance of common stock in public offering, net of offering costs
|
3,365,854
|
|
|
34
|
|
|
32,272
|
|
|
—
|
|
|
32,306
|
|
||||
Issuance of common stock upon exercise of stock options for cash
|
101,395
|
|
|
1
|
|
|
368
|
|
|
—
|
|
|
369
|
|
||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
4,281
|
|
|
—
|
|
|
4,281
|
|
||||
Warrant modification
|
—
|
|
|
—
|
|
|
511
|
|
|
—
|
|
|
511
|
|
||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(38,444
|
)
|
|
(38,444
|
)
|
||||
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
||||
Balance at December 31, 2012
|
25,897,483
|
|
|
259
|
|
|
207,787
|
|
|
(214,577
|
)
|
|
(6,531
|
)
|
||||
Issuance of common stock in direct offering, net of offering costs
|
3,903,004
|
|
|
39
|
|
|
16,081
|
|
|
—
|
|
|
16,120
|
|
||||
Issuance of common stock utilizing At-The-Market Agreement, net of commissions
|
373,700
|
|
|
4
|
|
|
4,864
|
|
|
—
|
|
|
4,868
|
|
||||
Issuance of common stock upon exercise of stock options for cash
|
185,321
|
|
|
2
|
|
|
660
|
|
|
—
|
|
|
662
|
|
||||
Stock-based compensation
|
—
|
|
|
—
|
|
|
6,252
|
|
|
—
|
|
|
6,252
|
|
||||
Warrant modification
|
—
|
|
|
—
|
|
|
41
|
|
|
—
|
|
|
41
|
|
||||
Net loss
|
—
|
|
|
—
|
|
|
—
|
|
|
(39,796
|
)
|
|
(39,796
|
)
|
||||
|
|
|
|
|
|
|
|
|
|
|||||||||
Balance at December 31, 2013
|
30,359,508
|
|
|
$
|
304
|
|
|
$
|
235,685
|
|
|
$
|
(254,373
|
)
|
|
$
|
(18,384
|
)
|
|
Year Ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
Operating activities:
|
|
|
|
|
|
||||||
Net loss
|
$
|
(39,796
|
)
|
|
$
|
(38,444
|
)
|
|
$
|
(28,546
|
)
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
|
|
||||||
Depreciation and amortization
|
302
|
|
|
320
|
|
|
435
|
|
|||
Stock-based compensation expense
|
6,252
|
|
|
4,281
|
|
|
1,927
|
|
|||
Non-cash interest expense
|
502
|
|
|
354
|
|
|
352
|
|
|||
Warrant modification expense
|
41
|
|
|
511
|
|
|
—
|
|
|||
Changes in operating assets and liabilities:
|
|
|
|
|
|
||||||
Grant and other receivables
|
1,555
|
|
|
(1,059
|
)
|
|
2,254
|
|
|||
Prepaid expenses and other current and noncurrent assets
|
84
|
|
|
(438
|
)
|
|
(201
|
)
|
|||
Accounts payable and accrued liabilities
|
(1,169
|
)
|
|
(2
|
)
|
|
339
|
|
|||
Deferred revenue
|
(970
|
)
|
|
(4,718
|
)
|
|
(2,228
|
)
|
|||
Deferred rent
|
3,504
|
|
|
4,644
|
|
|
—
|
|
|||
Net cash used in operating activities
|
(29,695
|
)
|
|
(34,551
|
)
|
|
(25,668
|
)
|
|||
Investing activities:
|
|
|
|
|
|
||||||
Purchases of property and equipment
|
(204
|
)
|
|
(642
|
)
|
|
(1,241
|
)
|
|||
Purchases of investments
|
(47,182
|
)
|
|
(49,547
|
)
|
|
(9,000
|
)
|
|||
Proceeds from the sale and maturity of investments
|
55,295
|
|
|
49,282
|
|
|
27,150
|
|
|||
Net cash provided by (used in) investing activities
|
7,909
|
|
|
(907
|
)
|
|
16,909
|
|
|||
Financing activities:
|
|
|
|
|
|
||||||
Proceeds from issuance of common stock, net of offering costs
|
20,988
|
|
|
32,306
|
|
|
—
|
|
|||
Net proceeds from borrowings under notes payable
|
—
|
|
|
6,492
|
|
|
9,942
|
||||
Payments on notes payable
|
—
|
|
|
(6,194
|
)
|
|
(1,051
|
)
|
|||
Proceeds from issuance of common stock upon exercise of stock options
|
662
|
|
|
369
|
|
|
595
|
|
|||
Net cash provided by financing activities
|
21,650
|
|
|
32,973
|
|
|
9,486
|
|
|||
Net decrease) increase in cash and cash equivalents
|
(136
|
)
|
|
(2,485
|
)
|
|
727
|
||||
Cash and cash equivalents at beginning of period
|
1,520
|
|
|
4,005
|
|
|
3,278
|
||||
Cash and cash equivalents at end of period
|
$
|
1,384
|
|
|
$
|
1,520
|
|
|
$
|
4,005
|
|
Supplemental cash flow information
|
|
|
|
|
|
||||||
Cash paid for interest
|
$
|
1,709
|
|
|
$
|
1,502
|
|
|
$
|
1,461
|
|
Reduction of equipment cost basis due to assets purchased with grant funding
|
$
|
—
|
|
|
$
|
60
|
|
|
$
|
1,689
|
|
Property acquired under capital lease
|
$
|
—
|
|
|
$
|
30
|
|
|
$
|
—
|
|
|
Year Ended December 31,
|
|||||||
|
2013
|
|
2012
|
|
2011
|
|||
Outstanding options to purchase common stock
|
6,969,303
|
|
|
5,269,353
|
|
|
3,006,567
|
|
Warrants to purchase common stock
|
609,016
|
|
|
609,016
|
|
|
609,016
|
|
Total
|
7,578,319
|
|
|
5,878,369
|
|
|
3,615,583
|
|
|
December 31, 2013
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
|
(In thousands)
|
||||||||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money-market funds classified as cash equivalents
|
$
|
213
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
213
|
|
Money-market funds classified as non-current restricted cash
|
679
|
|
|
—
|
|
|
—
|
|
|
679
|
|
||||
Money-market funds classified as short-term investments
|
12,717
|
|
|
—
|
|
|
—
|
|
|
12,717
|
|
||||
Total
|
$
|
13,609
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
13,609
|
|
|
December 31, 2012
|
||||||||||||||
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
|
(In thousands)
|
||||||||||||||
Assets:
|
|
|
|
|
|
|
|
||||||||
Money-market funds classified as cash equivalents
|
$
|
21
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
21
|
|
Money-market funds classified as current restricted cash
|
193
|
|
|
—
|
|
|
—
|
|
|
193
|
|
||||
Money-market funds classified as non-current restricted cash
|
679
|
|
|
—
|
|
|
—
|
|
|
679
|
|
||||
Money-market funds classified as short-term investments
|
20,830
|
|
|
—
|
|
|
—
|
|
|
20,830
|
|
||||
Total
|
$
|
21,723
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
21,723
|
|
|
December 31,
|
||||||
|
2013
|
|
2012
|
||||
|
(In thousands)
|
||||||
Grant funding receivables
|
$
|
308
|
|
|
$
|
402
|
|
Lease incentives receivable
|
—
|
|
|
1,488
|
|
||
Other receivables
|
71
|
|
|
44
|
|
||
Total grant and other receivables
|
$
|
379
|
|
|
$
|
1,934
|
|
|
December 31,
|
||||||
|
2013
|
|
2012
|
||||
|
(In thousands)
|
||||||
Computer equipment
|
$
|
431
|
|
|
$
|
394
|
|
Computer software
|
127
|
|
|
98
|
|
||
Office equipment and furniture
|
615
|
|
|
500
|
|
||
Capital lease equipment
|
231
|
|
|
231
|
|
||
Laboratory equipment
|
1,626
|
|
|
1,603
|
|
||
Total
|
3,030
|
|
|
2,826
|
|
||
Less accumulated depreciation and amortization
|
(2,091
|
)
|
|
(1,789
|
)
|
||
Total property and equipment, net
|
$
|
939
|
|
|
$
|
1,037
|
|
|
December 31,
|
||||||
|
2013
|
|
2012
|
||||
|
(In thousands)
|
||||||
Employee costs
|
$
|
1,346
|
|
|
$
|
458
|
|
Clinical trials
|
596
|
|
|
1,842
|
|
||
Contract research
|
858
|
|
|
1,447
|
|
||
Consulting & professional fees
|
649
|
|
|
575
|
|
||
Other accruals
|
495
|
|
|
435
|
|
||
Total accrued liabilities
|
$
|
3,944
|
|
|
$
|
4,757
|
|
Year Ending December 31,
|
Total
|
||
|
(In thousands)
|
||
2014
|
$
|
6,116
|
|
2015
|
6,683
|
|
|
2016
|
7,295
|
|
|
2017
|
5
|
|
|
2018
|
—
|
|
|
Total future principal payments
|
$
|
20,099
|
|
Year Ending December 31,
|
Total
|
||
|
(In thousands)
|
||
2014
|
$
|
1,517
|
|
2015
|
7,226
|
|
|
2016
|
10,400
|
|
|
2017
|
11,403
|
|
|
2018
|
3,017
|
|
|
Total future principal payments
|
$
|
33,563
|
|
|
Year Ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
|
(In thousands)
|
||||||||||
Vulcan Inc.
|
$
|
970
|
|
|
$
|
4,677
|
|
|
$
|
2,000
|
|
Life Science Development Fund Authority (LSDF)
|
—
|
|
|
624
|
|
|
2,028
|
|
|||
Small Business Innovative Research Grant (SBIR)
|
630
|
|
|
721
|
|
|
266
|
|
|||
Other Revenue
|
—
|
|
|
—
|
|
|
230
|
|
|||
Total revenue
|
$
|
1,600
|
|
|
$
|
6,022
|
|
|
$
|
4,524
|
|
Year Ending December 31,
|
|
Lease
Payments |
|
Sublease
Income |
|
Net Lease
Payments |
||||||
|
|
(In thousands)
|
||||||||||
2014
|
|
$
|
3,232
|
|
|
$
|
550
|
|
|
$
|
2,682
|
|
2015
|
|
3,976
|
|
|
550
|
|
|
3,426
|
|
|||
2016
|
|
4,066
|
|
|
550
|
|
|
3,516
|
|
|||
2017
|
|
4,158
|
|
|
480
|
|
|
3,678
|
|
|||
2018
|
|
4,253
|
|
|
—
|
|
|
4,253
|
|
|||
Thereafter
|
|
42,063
|
|
|
—
|
|
|
42,063
|
|
|||
Total
|
|
$
|
61,748
|
|
|
$
|
2,130
|
|
|
$
|
59,618
|
|
Options granted and outstanding
|
6,969,303
|
|
Options available for future grant
|
413,330
|
|
Common stock warrants
|
609,016
|
|
Total shares reserved
|
7,991,649
|
|
Outstanding At
December 31, 2013 |
|
Expiration Date
|
|
Exercise Price
|
197,478
|
|
March 29, 2014
|
|
$12.25
|
133,333
|
|
October 21, 2015
|
|
20.00
|
133,333
|
|
October 21, 2015
|
|
30.00
|
133,333
|
|
October 21, 2015
|
|
40.00
|
11,539
|
|
April 26, 2015
|
|
9.13
|
609,016
|
|
|
|
$23.85
|
•
|
five percent
of the outstanding shares of our common stock on the last day of the immediately preceding fiscal year;
|
•
|
1,785,714
shares; or
|
•
|
such other amount as our board of directors may determine.
|
|
Year Ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
Estimated weighted-average fair value
|
$
|
6.87
|
|
|
$
|
7.35
|
|
|
$
|
3.31
|
|
Weighted-average assumptions:
|
|
|
|
|
|
||||||
Expected volatility
|
88
|
%
|
|
86
|
%
|
|
83
|
%
|
|||
Expected term, in years
|
5.8
|
|
|
5.7
|
|
|
5.7
|
|
|||
Risk-free interest rate
|
1.66
|
%
|
|
0.95
|
%
|
|
1.97
|
%
|
|||
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
(A)
|
Expected Volatility.
Because of our limited trading history, the expected volatility rate used to value stock option grants is based on volatilities of a peer group of similar companies whose share prices are publicly available. The peer group was developed based on companies in the pharmaceutical and biotechnology industry in a similar stage of development.
|
(B)
|
Expected Term.
We elected to utilize the "simplified" method for "plain vanilla" options to determine the expected term of our stock option grants. Under this approach, the weighted-average expected life is presumed to be the average of the vesting term and the contractual term of the option.
|
(C)
|
Risk-free Interest Rate.
The risk-free interest rate assumption was based on zero-coupon U.S. Treasury instruments that had terms consistent with the expected term of our stock option grants.
|
(D)
|
Expected Dividend Yield.
We have never declared or paid any cash dividends and do not presently plan to pay cash dividends in the foreseeable future.
|
|
Year Ended December 31,
|
||||||||||
|
2013
|
|
2012
|
|
2011
|
||||||
|
(In thousands)
|
||||||||||
Research and development
|
$
|
3,588
|
|
|
$
|
2,191
|
|
|
$
|
819
|
|
Selling, general and administrative
|
2,664
|
|
|
2,090
|
|
|
1,108
|
|
|||
Total stock-based compensation expense
|
$
|
6,252
|
|
|
$
|
4,281
|
|
|
$
|
1,927
|
|
|
Options
Outstanding
|
|
Weighted-
Average
Exercise
Price per
Share
|
|
Remaining
Contractual Life
(in years)
|
|
Aggregate
Intrinsic
Value
(In thousands)
|
|||||
Balance at December 31, 2012
|
5,390,582
|
|
|
$
|
5.18
|
|
|
|
|
|
||
Granted
|
1,943,301
|
|
|
9.52
|
|
|
|
|
|
|||
Exercised
|
(185,321
|
)
|
|
3.57
|
|
|
|
|
|
|||
Forfeited and expired
|
(179,259
|
)
|
|
7.52
|
|
|
|
|
|
|||
Balance at December 31, 2013
|
6,969,303
|
|
|
$
|
6.38
|
|
|
7.20
|
|
$
|
34,262
|
|
Vested and expected to vest at December 31, 2013
|
6,692,208
|
|
|
$
|
6.27
|
|
|
7.12
|
|
$
|
33,588
|
|
Exercisable at December 31, 2013
|
4,072,707
|
|
|
$
|
4.57
|
|
|
5.82
|
|
$
|
27,385
|
|
|
|
December 31, 2013
|
||||||||||||||
|
|
Options Outstanding
|
|
Options Exercisable
|
||||||||||||
Range of Exercise Price
|
|
Number of
Options
|
|
Weighted-
Average
Remaining
Contractual
Life (Years)
|
|
Weighted-
Average
Exercise
Price
|
|
Number of
Options
|
|
Weighted-
Average
Exercise
Price
|
||||||
$0.98 - $4.10
|
|
2,688,757
|
|
|
4.97
|
|
$
|
2.31
|
|
|
2,336,148
|
|
|
$
|
2.03
|
|
$4.53 - $6.42
|
|
891,051
|
|
|
6.44
|
|
6.13
|
|
|
810,558
|
|
|
6.15
|
|
||
$7.29 - $10.19
|
|
2,101,090
|
|
|
9.34
|
|
9.11
|
|
|
479,382
|
|
|
8.74
|
|
||
$10.40 - $13.49
|
|
1,288,405
|
|
|
8.90
|
|
10.59
|
|
|
446,619
|
|
|
10.48
|
|
||
$0.98 - $13.49
|
|
6,969,303
|
|
|
7.20
|
|
$
|
6.38
|
|
|
4,072,707
|
|
|
$
|
4.57
|
|
|
December 31,
|
||||||
|
2013
|
|
2012
|
||||
|
(In thousands)
|
||||||
Deferred tax assets:
|
|
|
|
||||
Net operating loss carryforwards
|
$
|
68,942
|
|
|
$
|
59,124
|
|
Deferred rent
|
2,770
|
|
|
1,579
|
|
||
Stock-based compensation
|
3,537
|
|
|
2,183
|
|
||
Research and development tax credits
|
5,707
|
|
|
3,775
|
|
||
Other
|
1,866
|
|
|
1,614
|
|
||
Total
|
82,822
|
|
|
68,275
|
|
||
Less valuation allowance
|
(82,822
|
)
|
|
(68,275
|
)
|
||
Net deferred tax assets
|
$
|
—
|
|
|
$
|
—
|
|
|
Year ended December 31,
|
||||
|
2013
|
|
2012
|
|
2011
|
Statutory tax rate
|
(34)%
|
|
(34)%
|
|
(34)%
|
Permanent difference
|
3%
|
|
2%
|
|
1%
|
Change in valuation allowance
|
36%
|
|
35%
|
|
33%
|
Research and development credit
|
(5)%
|
|
—%
|
|
—%
|
Other
|
—%
|
|
(3)%
|
|
—%
|
Effective tax rate
|
—%
|
|
—%
|
|
—%
|
2013
|
|
For the Quarter Ended
|
||||||||||||||
|
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
||||||||
Revenue
|
|
$
|
1,095
|
|
|
$
|
140
|
|
|
$
|
196
|
|
|
$
|
169
|
|
Total operating expenses
|
|
11,115
|
|
|
13,300
|
|
|
13,630
|
|
|
14,071
|
|
||||
Loss from operations
|
|
(10,020
|
)
|
|
(13,160
|
)
|
|
(13,434
|
)
|
|
(13,902
|
)
|
||||
Net loss
|
|
(10,489
|
)
|
|
(13,592
|
)
|
|
(13,870
|
)
|
|
(1,845
|
)
|
||||
Basic and diluted net loss per share
|
|
$
|
(0.40
|
)
|
|
$
|
(0.48
|
)
|
|
$
|
(0.46
|
)
|
|
$
|
(0.05
|
)
|
|
||||||||||||||||
|
||||||||||||||||
2012
|
|
For the Quarter Ended
|
||||||||||||||
|
|
March 31,
|
|
June 30,
|
|
September 30,
|
|
December 31,
|
||||||||
Revenue
|
|
$
|
1,496
|
|
|
$
|
1,526
|
|
|
$
|
1,417
|
|
|
$
|
1,583
|
|
Total operating expenses
|
|
9,568
|
|
|
9,770
|
|
|
14,453
|
|
|
9,116
|
|
||||
Loss from operations
|
|
(8,072
|
)
|
|
(8,244
|
)
|
|
(13,036
|
)
|
|
(7,533
|
)
|
||||
Net loss
|
|
(8,895
|
)
|
|
(8,539
|
)
|
|
(13,276
|
)
|
|
(7,734
|
)
|
||||
Basic and diluted net loss per share
|
|
$
|
(0.40
|
)
|
|
$
|
(0.38
|
)
|
|
$
|
(0.51
|
)
|
|
$
|
(0.30
|
)
|
Exhibit
Number
|
Footnote
Reference
|
Description
|
|
|
|
3.1
|
(1)
|
Amended and Restated Articles of Incorporation of Omeros Corporation
|
|
|
|
3.2
|
(1)
|
Amended and Restated Bylaws of Omeros Corporation
|
|
|
|
4.1
|
(2)
|
Form of Omeros Corporation common stock certificate
|
|
|
|
4.2
|
(3)
|
Stock Purchase Warrant issued by nura, inc. to Oxford Finance Corporation dated April 26, 2005 (assumed by Omeros Corporation on August 11, 2006)
|
|
|
|
4.3
|
(3)
|
Amended and Restated Investors' Rights Agreement among Omeros Corporation and holders of capital stock dated October 15, 2004
|
|
|
|
4.4
|
(4)
|
Form of Omeros Corporation Stock Purchase Warrant (as of December 31, 2012, warrants in this form were issued to purchase up to a total of 167,885 shares of common stock)
|
|
|
|
4.5
|
(4)
|
Form of Omeros Corporation Stock Purchase Warrant (as of December 31, 2012, warrants in this form were issued to purchase up to a total of 29,593 shares of common stock)
|
|
|
|
4.6
|
(4)
|
Form of Notice of Waiver of Warrant Termination (applicable to Stock Purchase Warrants filed as Exhibits 4.4 and 4.5)
|
|
|
|
4.7
|
(5)
|
Notice Regarding the Extension of the Expiration Date of Certain Stock Purchase Warrants to March 29, 2013 (applicable to Stock Purchase Warrants filed as Exhibits 4.4 and 4.5)
|
|
|
|
4.8
|
(23)
|
Notice Regarding the Extension of the Expiration Date to March 29, 2014 of Warrants to Purchase up to an Aggregate of 197,478 Shares of the Common Stock of the Registrant (applicable to Stock Purchase Warrants filed as Exhibits 4.4 and 4.5)
|
|
|
|
4.9
|
(6)
|
Form of Common Stock Warrant issued by Omeros Corporation to Cougar Investment Holdings LLC, which warrants were subsequently assigned to its affiliate Vulcan Capital Venture Capital II LLC (as of December 31, 2012, warrants in this form were issued to purchase of up to a total of 399,999 shares of common stock)
|
|
|
|
10.1
|
(3)*
|
Form of Indemnification Agreement entered into between Omeros Corporation and its directors and officers
|
|
|
|
10.2
|
(3)*
|
Second Amended and Restated 1998 Stock Option Plan
|
|
|
|
10.3
|
(3)*
|
Form of Stock Option Agreement under the Second Amended and Restated 1998 Stock Option Plan (that does not permit early exercise)
|
|
|
|
10.4
|
(3)*
|
nura, inc. 2003 Stock Plan
|
|
|
|
10.5
|
(3)*
|
Form of Stock Option Agreement under the nura, inc. 2003 Stock Plan
|
|
|
|
10.6
|
(7)*
|
2008 Equity Incentive Plan
|
|
|
|
10.7
|
(26)*
|
Form of Stock Option Award Agreement under the 2008 Equity Incentive Plan
|
|
|
|
10.8
|
(8)*
|
Second Amended and Restated Employment Agreement between Omeros Corporation and Gregory A. Demopulos, M.D. dated April 7, 2010
|
|
|
|
10.9
|
(3)*
|
Offer Letter between Omeros Corporation and Marcia S. Kelbon, Esq. dated August 16, 2001
|
|
|
|
10.10
|
(3)*
|
Technology Transfer Agreement between Omeros Corporation and Gregory A. Demopulos, M.D. dated June 16, 1994
|
|
|
|
10.11
|
(3)
|
Technology Transfer Agreement between Omeros Corporation and Pamela Pierce, M.D., Ph.D. dated June 16, 1994
|
|
|
|
10.12
|
(3)*
|
Second Technology Transfer Agreement between Omeros Corporation and Gregory A. Demopulos, M.D. dated December 11, 2001
|
|
|
|
10.13
|
(3)
|
Second Technology Transfer Agreement between Omeros Corporation and Pamela Pierce, M.D., Ph.D. dated March 22, 2002
|
|
|
|
10.14
|
(3)*
|
Technology Transfer Agreement between Omeros Corporation and Gregory A. Demopulos, M.D. dated June 16, 1994 (related to tendon splice technology)
|
|
|
|
10.15
|
(9)
|
Lease dated January 27, 2012 between Omeros Corporation and BMR-201 Elliott Avenue LLC
|
|
|
|
10.16
|
(10)
|
First Amendment to Lease dated November 5, 2012 between Omeros Corporation and BMR-201 Elliott Avenue LLC
|
|
|
|
10.17
|
(22)
|
Second Amendment to Lease dated November 16, 2012 between Omeros Corporation and BMR-201 Elliott Avenue LLC
|
|
|
|
10.18
|
|
Third Amendment to Lease dated October 16, 2013 between Omeros Corporation and BMR-201 Elliott Avenue LLC
|
|
|
|
10.19
|
(12)
|
Amended and Restated Settlement Agreement effective as of October 26, 2012 among Omeros Corporation, Gregory A. Demopulos, M.D. and Richard J. Klein
|
|
|
|
10.20
|
|
Settlement Agreement and Release effective as of October 2, 2013 among Omeros Corporation, Gregory A. Demopulos, M.D. and Carolina Casualty Insurance Company.
|
|
|
|
10.21
|
(4)†
|
Commercial Supply Agreement between Omeros Corporation and Hospira Worldwide, Inc. dated October 9, 2007
|
|
|
|
10.22
|
(4)†
|
Exclusive License and Sponsored Research Agreement between Omeros Corporation and the University of Leicester dated June 10, 2004
|
|
|
|
10.23
|
(3)†
|
Research and Development Agreement First Amendment between Omeros Corporation and the University of Leicester dated October 1, 2005
|
|
|
|
10.24
|
(4)†
|
Exclusive License and Sponsored Research Agreement between Omeros Corporation and the Medical Research Council dated October 31, 2005
|
|
|
|
10.25
|
(3)†
|
Amendment dated May 8, 2007 to Exclusive License and Sponsored Research Agreement between Omeros Corporation and the Medical Research Council dated October 31, 2005
|
|
|
|
10.26
|
(13)†
|
Funding Agreement between Omeros Corporation and The Stanley Medical Research Institute dated December 18, 2006
|
|
|
|
10.27
|
(4)†
|
Patent Assignment Agreement between Omeros Corporation and Roberto Ciccocioppo, Ph.D. dated February 23, 2009
|
|
|
|
10.28
|
(22)†
|
First Amendment to Patent Assignment Agreement between Omeros Corporation and Roberto Ciccocioppo, Ph.D. effective December 31, 2010
|
|
|
|
10.29
|
(4)*
|
Omeros Corporation Non-Employee Director Compensation Policy
|
|
|
|
10.30
|
(14)†
|
License Agreement between Omeros Corporation and Daiichi Sankyo Co., Ltd. (successor-in-interest to Asubio Pharma Co., Ltd.) dated March 3, 2010
|
|
|
|
10.31
|
(15)†
|
Amendment No. 1 to License Agreement with an effective date of January 5, 2011 between Omeros Corporation and Daiichi Sankyo Co., Ltd.
|
|
|
|
10.32
|
(24)†
|
Amendment No. 2 to License Agreement with an effective date of January 25, 2013 between Omeros Corporation and Daiichi Sankyo Co., Ltd.
|
|
|
|
10.53
|
(27)
|
Loan and Security Agreement among Omeros Corporation, Oxford Finance LLC and MidCap Financial SBIC, LP dated March 5, 2014
|
|
|
|
10.54
|
(27)
|
Form of Secured Promissory Note issued by the registrant to Oxford Finance LLC dated March 5, 2014
|
|
|
|
10.55
|
(27)
|
Form of Secured Promissory Note issued by the registrant to MidCap Financial SBIC, LP dated March 5, 2014
|
|
|
|
12.1
|
|
Ratio of Earnings to Fixed Charges
|
|
|
|
23.1
|
|
Consent of Independent Registered Public Accounting Firm
|
|
|
|
31.1
|
|
Certification of Principal Executive Officer Pursuant to Rule 13-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
31.2
|
|
Certification of Principal Financial Officer Pursuant to Rule 13-14(a) or Rule 15d-14(a) of the Securities Exchange Act of 1934 as Adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002
|
|
|
|
32.1
|
|
Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
32.2
|
|
Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as Adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002
|
|
|
|
99.1
|
|
Description of Omeros Corporation Securities
|
|
|
|
101.INS**
|
|
XBRL Instance Document
|
|
|
|
101.SCH**
|
|
XBRL Taxonomy Extension Schema Document
|
|
|
|
101.CAL**
|
|
XBRL Taxonomy Extension Calculation Linkbase Document
|
|
|
|
101.DEF**
|
|
XBRL Taxonomy Extension Definition Linkbase Document
|
|
|
|
101.LAB**
|
|
XBRL Taxonomy Extension Labels Linkbase Document
|
|
|
|
101.PRE**
|
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
(1)
|
Incorporated by reference from the Annual Report on Form 10-K filed by Omeros Corporation on March 31, 2010 (File No. 001-34475).
|
(2)
|
Incorporated by reference from the Registration Statement on Form S-1/A filed by Omeros Corporation on October 2, 2009 (File No. 333-148572).
|
(3)
|
Incorporated by reference from the Registration Statement on Form S-1 filed by Omeros Corporation on January 9, 2008 (File No. 333-148572).
|
(4)
|
Incorporated by reference from the Registration Statement on Form S-1/A filed by Omeros Corporation on September 16, 2009 (File No. 333-148572).
|
(5)
|
Incorporated by reference from the Current Report on Form 8-K filed by Omeros Corporation on March 29, 2012 (File No. 001-34475).
|
(6)
|
Incorporated by reference from the Current Report on Form 8-K filed by Omeros Corporation on October 25, 2010 (File No. 001-34475).
|
(7)
|
Incorporated by reference from the Registration Statement on Form S-1/A filed by Omeros Corporation on April 1, 2008 (File No. 333-148572).
|
(8)
|
Incorporated by reference from the Current Report on Form 8-K filed by Omeros Corporation on April 12, 2010 (File No. 001-34475).
|
(9)
|
Incorporated by reference from the Current Report on Form 8-K filed by Omeros Corporation on February 1, 2012 (File No. 001-34475).
|
(10)
|
Incorporated by reference from the Quarterly Report on Form 10-Q filed by Omeros Corporation on November 9, 2012 (File No. 001-34475).
|
(11)
|
Incorporated by reference from the Current Report on Form 8-K filed by Omeros Corporation on September 28, 2012 (File No. 001-34475).
|
(12)
|
Incorporated by reference from the Current Report on Form 8-K filed by Omeros Corporation on November 1, 2012 (File No. 001-34475).
|
(13)
|
Incorporated by reference from the Registration Statement on Form S-1/A filed by Omeros Corporation on May 15, 2009 (File No. 333-148572).
|
(14)
|
Incorporated by reference from the Quarterly Report on Form 10-Q filed by Omeros Corporation on May 12, 2010 (File No. 001-34475).
|
(15)
|
Incorporated by reference from the Quarterly Report on Form 10-Q filed by Omeros Corporation on May 10, 2011 (File No. 001-34475).
|
(16)
|
Incorporated by reference from the Quarterly Report on Form 10-Q filed by Omeros Corporation on August 10, 2010 (File No. 001-34475).
|
(17)
|
Incorporated by reference from the Current Report on Form 8-K filed by Omeros Corporation on May 10, 2011 (File No. 001-34475).
|
(18)
|
Incorporated by reference from the Current Report on Form 8-K filed by Omeros Corporation on December 14, 2012 (File No. 001-34475).
|
(19)
|
Incorporated by reference from the Current Report on Form 8-K filed by Omeros Corporation on March 31, 2011 (File No. 001-34475).
|
(20)
|
Incorporated by reference from the Current Report on Form 8-K filed by Omeros Corporation on January 2, 2013 (File No. 001-34475).
|
(21)
|
Incorporated by reference from the Annual Report on Form 10-K filed by Omeros Corporation on March 15, 2011 (File No. 001-34475).
|
(22)
|
Incorporated by reference from the Annual Report on Form 10-K filed by Omeros Corporation on March 18, 2013 (File No. 001-34475).
|
(23)
|
Incorporated by reference from the Current Report on Form 8-K filed by Omeros Corporation on March 29, 2013 (File No. 001-34475).
|
(24)
|
Incorporated by reference from the Quarterly Report on Form 10-Q filed by Omeros Corporation on May 9, 2013 (File No. 001-34475).
|
(25)
|
Incorporated by reference from the Current Report on Form 8-K filed by Omeros Corporation on May 10, 2013 (File No. 001-34475).
|
(26)
|
Incorporated by reference from the Quarterly Report on Form 10-Q filed by Omeros Corporation on November 7, 2013 (File No. 001-34475).
|
(27)
|
Incorporated by reference from the Current Report on Form 8-K filed by Omeros Corporation on March 5, 2014 (File No. 001-34475).
|
*
|
Indicates management contract or compensatory plan or arrangement.
|
†
|
Portions of this exhibit are redacted in accordance with a grant of confidential treatment.
|
††
|
Portions of this exhibit are redacted in accordance with a request for confidential treatment.
|
**
|
XBRL (Extensible Business Reporting Language) information is furnished and not filed or a part of a registration statement or prospectus for purposes of Sections 11 or 12 of the Securities Act of 1933, as amended, is deemed not filed for purposes of Section 18 of the Securities Exchange Act of 1934, as amended, and otherwise is not subject to liability under those sections.
|
Dates
|
Square Feet of Rentable Area
|
Annual Base Rent per Square Foot of Rentable Area
|
Monthly Base Rent
|
Annual Base Rent
|
November 16, 2012 - November 15, 2013
|
64,483
|
$0.00
|
N/A
|
N/A
|
November 16, 2013 - November 15, 2014
|
64,483*
|
$51.27
|
$213,617.29
|
$2,563,407.48
|
November 16, 2014 - November 15, 2015
|
64,483
|
$50.99
|
$273,974.29
|
$3,287,691.48
|
November 16, 2015 - November 15, 2016
|
64,483
|
$52.14
|
$280,170.29
|
$3,362,043.48
|
November 16, 2016 - November 15, 2017
|
64,483
|
$53.32
|
$286,522.29
|
$3,438,267.48
|
November 16, 2017 - November 15, 2018
|
64,483
|
$54.53
|
$293,032.29
|
$3,516,387.48
|
November 16, 2018 - November 15, 2019
|
64,483
|
$55.77
|
$299,705.29
|
$3,596,463.48
|
November 16, 2019 - November 15, 2020
|
64,483
|
$57.05
|
$306,544.29
|
$3,678,531.48
|
November 16, 2020 - November 15, 2021
|
64,483
|
$58.35
|
$313,555.29
|
$3,762,663.48
|
November 16, 2021 - November 15, 2022
|
64,483
|
$59.69
|
$320,741.29
|
$3,848,895.48
|
November 16, 2022 - November 15, 2023
|
64,483
|
$61.06
|
$328,107.29
|
$3,937,287.48
|
November 16, 2023 - November 15, 2024
|
64,483
|
$62.46
|
$335,656.29
|
$4,027,875.48
|
November 16, 2024 - November 15, 2025
|
64,483
|
$63.90
|
$343,395.29
|
$4,120,743.48
|
November 16, 2025 - November 15, 2026
|
64,483
|
$65.38
|
$351,327.29
|
$4,215,927.48
|
November 16, 2026 - November 15, 2027
|
64,483
|
$66.89
|
$359,457.29
|
$4,313,487.48
|
Termination Date
|
Termination Fee
|
Months 96 - 120
|
The sum of (a) the applicable amount set forth in the chart below (the “
Initial Termination Fee
”), (b) thirty percent (30%) of the unamortized portion of the actual cost of any Expansion Space tenant improvements* and (c) thirty percent (30%) of the unamortized portion of the Additional Work Cost**
|
Months 121 - 180
|
The sum of (a) the applicable Initial Termination Fee, (b) twenty percent (20%) of the unamortized portion of the actual cost of any Expansion Space tenant improvements* and (c) twenty percent (20%) of the unamortized portion of the Additional Work Cost**
|
Description
|
Amount
|
Main Project AV Equipment procurement, installation, and testing
|
$323,095.00
|
Add Door Gaskets and Bottoms at Vivarium Doors
|
$ 2,453.06
|
Executive Suite-Level 5 Column Covers to Cover Exposed Column from Backside or West Side
|
$3,432.55
|
Add 17 Armor Plates to Vivarium (shared cage rack wash area)
|
$ 2,929.86
|
|
$331,910.47
|
LENDER:
OXFORD FINANCE LLC
By:
/s/ Mark Davis
Name:Mark Davis
Title:Vice President - Finance, Secretary & Treasurer
LENDER:
OXFORD FINANCE FUNDING TRUST 2012-01
BY: Oxford Finance LLC, as servicer
By:
/s/ Mark Davis
Name:Mark Davis
Title:Vice President - Finance, Secretary & Treasurer
LENDER:
OXFORD FINANCE FUNDING I, LLC
BY: Oxford Finance LLC, as servicer
By:
/s/ Mark Davis
Name:Mark Davis
Title:Vice President - Finance, Secretary & Treasurer
|
BORROWER:
OMEROS CORPORATION
By:
/s/ Gregory A. Demopulos, M.D.
Name:/s/ Gregory A. Demopulos, M.D.
Title:Chairman and CEO
|
|
EXHIBIT 12.1
|
|
|||||||||||||
|
|
|
|||||||||||||
Omeros Corporation
|
|||||||||||||||
Computation of Deficiency in the Coverage of Fixed Charges by Earnings Before Fixed Charges
|
|||||||||||||||
|
|
|
|||||||||||||
|
|
|
|||||||||||||
|
Year Ended December 31,
|
||||||||||||||
|
2013
|
2012
|
2011
|
2010
|
2009
|
||||||||||
|
(In thousands)
|
||||||||||||||
Earnings before fixed charges:
|
|
|
|
|
|||||||||||
Loss from continuing operations before income taxes
|
$
|
(39,796
|
)
|
$
|
(38,444
|
)
|
$
|
(28,546
|
)
|
$
|
(29,251
|
)
|
$
|
(21,089
|
)
|
Add fixed charges
|
5,621
|
|
2,305
|
|
2,144
|
|
2,104
|
|
2,596
|
|
|||||
Add amortization of capitalized interest
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
|||||
Add distributed income of equity investees
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
|||||
Subtract capitalized interest
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
|||||
Loss before fixed charges
|
$
|
(34,175
|
)
|
$
|
(36,139
|
)
|
$
|
(26,402
|
)
|
$
|
(27,147
|
)
|
$
|
(18,493
|
)
|
Fixed Charges:
|
|
|
|
|
|
||||||||||
Interest expense
|
$
|
1,865
|
|
$
|
1,355
|
|
$
|
1,532
|
|
$
|
1,328
|
|
$
|
1,948
|
|
Amortization of debt expense and loss from extinguishment of debt
|
502
|
|
374
|
|
352
|
|
503
|
|
254
|
|
|||||
Estimate of interest expense within rental expense
|
3,254
|
|
576
|
|
260
|
|
273
|
|
394
|
|
|||||
Preference security dividend requirements of consolidated subsidiaries
|
—
|
|
—
|
|
—
|
|
—
|
|
—
|
|
|||||
Total fixed charges
|
$
|
5,621
|
|
$
|
2,305
|
|
$
|
2,144
|
|
$
|
2,104
|
|
$
|
2,596
|
|
Deficiency of earnings available to cover fixed charges
|
$
|
(39,796
|
)
|
$
|
(38,444
|
)
|
$
|
(28,546
|
)
|
$
|
(29,251
|
)
|
$
|
(21,089
|
)
|
(1)
|
Registration Statement (Form S-8 No 333-162732) pertaining to the Omeros Corporation 2008 Equity Incentive Plan, the Omeros Corporation Second Amended And Restated 1998 Stock Option Plan, the Nura, Inc. 2003 Stock Option Plan, the Omeros Corporation Stock Option Grant to Gregory A. Demopulos, M.D., and the Omeros Corporation Stock Option Grant to Pamela Pierce Palmer, M.D., Ph.D.,
|
(2)
|
Registration Statement (Form S-8 No 333-165861) pertaining to the Omeros Corporation 2008 Equity Incentive Plan,
|
(3)
|
Registration Statement (Form S-8 No 333-172905) pertaining to the Omeros Corporation 2008 Equity Incentive Plan,
|
(4)
|
Registration Statement (Form S-3 No 333-169856) and related Prospectus of Omeros Corporation pertaining to the registration of $100,000,000 of common stock, preferred stock, debt securities, depository shares, warrants, or units,
|
(5)
|
Registration Statement (Form S-8 No 333-180216) pertaining to the Omeros Corporation 2008 Equity Incentive Plan,
|
(6)
|
Registration Statement (Form S-8 No 333-187344) pertaining to the Omeros Corporation 2008 Equity Incentive Plan, and
|
1.
|
I have reviewed this annual report on Form 10-K of Omeros Corporation;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b.
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c.
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a.
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b.
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
Dated: March 13, 2014
|
|
|
|
/s/ Gregory A. Demopulos
|
|
Gregory A. Demopulos, M.D.
Principal Executive Officer
|
1.
|
I have reviewed this annual report on Form 10-K of Omeros Corporation;
|
2.
|
Based on my knowledge, this report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this report;
|
3.
|
Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this report;
|
4.
|
The registrant’s other certifying officer(s) and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e) and 15d-15(e)) and internal control over financial reporting (as defined in Exchange Act Rules 13a-15(f) and 15d-15(f)) for the registrant and have:
|
a.
|
Designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the registrant, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this report is being prepared;
|
b.
|
Designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles;
|
c.
|
Evaluated the effectiveness of the registrant’s disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and
|
d.
|
Disclosed in this report any change in the registrant’s internal control over financial reporting that occurred during the registrant’s most recent fiscal quarter (the registrant’s fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect, the registrant’s internal control over financial reporting; and
|
5.
|
The registrant’s other certifying officer(s) and I have disclosed, based on our most recent evaluation of internal control over financial reporting, to the registrant’s auditors and the audit committee of the registrant’s board of directors (or persons performing the equivalent functions):
|
a.
|
All significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the registrant’s ability to record, process, summarize and report financial information; and
|
b.
|
Any fraud, whether or not material, that involves management or other employees who have a significant role in the registrant’s internal control over financial reporting.
|
|
Dated: March 13, 2014
|
|
|
|
/s/ Michael A. Jacobsen
|
|
Michael A. Jacobsen
|
|
Principal Financial and Accounting Officer
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
Dated: March 13, 2014
|
|
|
|
/s/ Gregory A. Demopulos
|
|
Gregory A. Demopulos, M.D.
|
|
Principal Executive Officer
|
(1)
|
The Report fully complies with the requirements of Section 13(a) or 15(d) of the Securities Exchange Act of 1934; and
|
(2)
|
The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company.
|
|
Dated: March 13, 2014
|
|
|
|
/s/ Michael A. Jacobsen
|
|
Michael A. Jacobsen
|
|
Principal Financial and Accounting Officer
|
•
|
restricting dividends on the common stock;
|
•
|
diluting the voting power of the common stock;
|
•
|
impairing the liquidation rights of the common stock; or
|
•
|
delaying or preventing changes in control or management of our company.
|
•
|
A warrant that we assumed in connection with our acquisition of nura, inc. on August 11, 2006 to purchase up to 11,539 shares of our common stock with an exercise price of $9.13 per share. This warrant will terminate upon the earlier of (a) April 26, 2015 and (b) certain acquisitions of us as described in the warrant.
|
•
|
Warrants issued on March 29, 2007 to purchase up to an aggregate of 197,478 shares of our common stock with an exercise price of $12.25 per share. Unless we extend the termination date of these warrants, they will terminate on the earlier of (a) a change of control as defined in the warrants and (b) March 29, 2014.
|
•
|
Three warrants issued on October 21, 2010, each to purchase up to 133,333 shares of our common stock, with exercise prices of $20.00, $30.00 and $40.00 per share, respectively. These warrants will terminate on October 21, 2015.
|
•
|
a merger or share exchange with, disposition of assets to, or issuance or redemption of stock to or from, the acquiring person;
|
•
|
a termination of five percent or more of the employees of the target corporation as a result of the acquiring person’s acquisition of 10% or more of the shares of the target corporation; or
|
•
|
a transaction in which the acquiring person is allowed to receive a disproportionate benefit as a shareholder.
|