Price Graph
Price
Yield
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x
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QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934
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o
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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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Large accelerated filer
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x
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Accelerated filer
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o
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Non-accelerated filer
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o
(Do not check if a smaller reporting company)
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Smaller reporting company
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o
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Emerging growth company
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o
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•
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our expectations relating to demand for OMIDRIA
®
(phenylephrine and ketorolac intraocular solution) 1%/0.3% from wholesalers, ambulatory surgery centers, or ASCs, and hospitals, and our expectations regarding OMIDRIA product sales, including once pass-through reimbursement status is reinstated pursuant to the Consolidated Appropriations Act, 2018, or the Appropriations Act;
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•
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our estimates of OMIDRIA chargebacks and rebates, distribution fees and product returns;
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•
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our estimates regarding how long our existing cash, cash equivalents, short-term investments and revenues will be sufficient to fund our anticipated operating expenses and capital expenditures, as well as our interest and principal payments on our outstanding notes under our Term Loan Agreement, or the CRG Loan Agreement, with CRG Servicing LLC, or CRG, and the lenders identified therein, and the satisfaction of covenants thereunder;
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•
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our expectations with respect to additional funding under the CRG Loan Agreement;
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•
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our expectations regarding the clinical, therapeutic and competitive benefits and importance of OMIDRIA and our product candidates;
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•
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our expectations related to obtaining permanent separate or similar reimbursement for OMIDRIA from the Centers for Medicare and Medicaid Services, or CMS, and/or from Congress, including after September 30, 2020;
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•
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our ability to design, initiate and/or successfully complete clinical trials and other studies for our products and product candidates and our plans and expectations regarding our clinical trials, including our clinical trials for OMS721, for OMS906 and for OMS527;
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•
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in our OMS721 program, our expectations regarding: whether enrollment in any or all ongoing and planned Phase 3 clinical trials will proceed as expected; whether accelerated approval, fast track designation, breakthrough therapy designation and/or orphan drug designation may be granted by the U.S. Food and Drug Administration, or FDA, or Priority Medicines status, conditional marketing authorization or orphan designation may be granted by the European Medicines Agency, or EMA, for indications for which we are pursuing such approval or designation; whether and when a Biologics License Application, or BLA, for accelerated approval of OMS721 may be filed with the FDA; paths to accelerated and full approval of OMS721 in hematopoietic stem cell transplant-associated thrombotic microangiopathy, or HSCT-TMA; and potential approval with respect to our Phase 3 clinical trial for patients with Immunoglobulin A, or IgA, nephropathy;
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•
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our anticipation that we will rely on contract manufacturers to manufacture OMIDRIA for commercial sale and to manufacture our product candidates for clinical trial supply and, if approved, for commercial sale;
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•
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our ability to enter into acceptable arrangements with potential corporate partners or contract service providers, including with respect to OMIDRIA, and our ability and plans to effect any such arrangement with respect to OMIDRIA in the European Union, or EU, and to place OMIDRIA on the market (i.e., released into the distribution chain) in at least one European Economic Area country prior to July 28, 2018 to preserve OMIDRIA marketing authorization in Europe;
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•
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our ability to raise additional capital through the capital markets or through one or more corporate partnerships, equity offerings, debt financings, collaborations, licensing arrangements or asset sales;
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•
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our expectations about the commercial competition that OMIDRIA and our product candidates, if commercialized, face or may face;
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•
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the expected course and costs of existing claims, legal proceedings and administrative actions, our involvement in potential claims, legal proceedings and administrative actions, and the merits, potential outcomes and effects of both existing and potential claims, legal proceedings and administrative actions, as well as regulatory determinations, on our business, prospects, financial condition and results of operations, including but not limited to our patent infringement lawsuits against Sandoz, Inc., or Sandoz, and against Lupin Ltd. and Lupin Pharmaceuticals, Inc., which we refer to collectively as Lupin;
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•
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the extent of protection that our patents provide and that our pending patent applications will provide, if patents issue from such applications, for our technologies, programs, products and product candidates;
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•
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the factors on which we base our estimates for accounting purposes and our expectations regarding the effect of changes in accounting guidance or standards on our operating results; and
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•
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our expected financial position, performance, revenues, growth, costs and expenses, magnitude of net losses and the availability of resources.
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Page
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March 31,
2018 |
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December 31,
2017 |
||||
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Assets
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||||
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Current assets:
|
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||||
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Cash and cash equivalents
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$
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1,189
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$
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3,394
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Short-term investments
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71,625
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80,355
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Receivables, net
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182
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17,144
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||
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Inventory
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247
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443
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Prepaid expense
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5,441
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7,036
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Total current assets
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78,684
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108,372
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Property and equipment, net
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2,081
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2,121
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Restricted investments
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5,835
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5,835
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Advanced payments, non-current
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2,435
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—
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||
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Total assets
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$
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89,035
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$
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116,328
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||||
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Liabilities and shareholders’ deficit
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||||
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Current liabilities:
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||||
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Accounts payable
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$
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10,183
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$
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6,691
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Accrued expenses
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13,934
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|
|
19,126
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||
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Current portion of lease financing obligations
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513
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490
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||
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Total current liabilities
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24,630
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|
26,307
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Notes payable and lease financing obligations, net
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85,037
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84,117
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Deferred rent
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8,583
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8,718
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Commitments and contingencies (Note 7)
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||||
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Shareholders’ deficit:
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||||
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Preferred stock, par value $0.01 per share, 20,000,000 shares authorized and none issued and outstanding at March 31, 2018 and December 31, 2017, respectively
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—
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—
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Common stock, par value $0.01 per share, 150,000,000 authorized; 48,286,842 and 48,211,226 issued and outstanding at March 31, 2018 and December 31, 2017 respectively
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483
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482
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Additional paid-in capital
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523,724
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520,072
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Accumulated deficit
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(553,422
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)
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(523,368
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)
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Total shareholders’ deficit
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(29,215
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)
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(2,814
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)
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Total liabilities and shareholders’ deficit
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$
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89,035
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$
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116,328
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Three Months Ended
March 31, |
||||||
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2018
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2017
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||||
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Revenue:
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||||
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Product sales, net
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$
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1,588
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$
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12,257
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||||
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Costs and expenses:
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||||
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Cost of product sales
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203
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271
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||
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Research and development
|
18,140
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12,240
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||
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Selling, general and administrative
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10,934
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12,471
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Total costs and expenses
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29,277
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|
24,982
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|
||
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Loss from operations
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(27,689
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)
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(12,725
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)
|
||
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Interest expense
|
(2,825
|
)
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|
(2,663
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)
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||
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Other income
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460
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|
|
299
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||
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Net loss
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$
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(30,054
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)
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$
|
(15,089
|
)
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Comprehensive loss
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$
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(30,054
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)
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$
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(15,089
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)
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|
Basic and diluted net loss per share
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$
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(0.62
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)
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$
|
(0.34
|
)
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|
Weighted-average shares used to compute basic and diluted net loss per share
|
48,284,019
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43,828,572
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||
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Three Months Ended
March 31, |
||||||
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2018
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2017
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||||
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Operating activities:
|
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|
|
||||
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Net loss
|
$
|
(30,054
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)
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$
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(15,089
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)
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|
Adjustments to reconcile net loss to net cash used in operating activities:
|
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||||
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Stock-based compensation expense
|
2,966
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|
3,276
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|
||
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Non-cash interest expense
|
1,086
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|
|
995
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|
||
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Depreciation and amortization
|
223
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|
|
115
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|
||
|
Changes in operating assets and liabilities:
|
|
|
|
||||
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Receivables
|
16,962
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|
|
(1,444
|
)
|
||
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Inventory
|
196
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|
|
168
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|
||
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Prepaid expenses and other assets
|
(840
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)
|
|
(1,494
|
)
|
||
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Accounts payable, accrued expenses and other
|
(1,835
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)
|
|
771
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|
||
|
Net cash used in operating activities
|
(11,296
|
)
|
|
(12,702
|
)
|
||
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Investing activities:
|
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|
|
||||
|
Purchases of property and equipment
|
(183
|
)
|
|
(72
|
)
|
||
|
Purchases of investments
|
(270
|
)
|
|
(1,042
|
)
|
||
|
Proceeds from the sale and maturities of investments
|
9,000
|
|
|
11,778
|
|
||
|
Net cash provided by investing activities
|
8,547
|
|
|
10,664
|
|
||
|
Financing activities:
|
|
|
|
||||
|
Proceeds upon exercise of stock options
|
687
|
|
|
1,147
|
|
||
|
Payments on lease financing obligations
|
(143
|
)
|
|
(51
|
)
|
||
|
Net cash provided by financing activities
|
544
|
|
|
1,096
|
|
||
|
Net decrease in cash and cash equivalents
|
(2,205
|
)
|
|
(942
|
)
|
||
|
Cash and cash equivalents at beginning of period
|
3,394
|
|
|
2,224
|
|
||
|
Cash and cash equivalents at end of period
|
$
|
1,189
|
|
|
$
|
1,282
|
|
|
Supplemental cash flow information
|
|
|
|
||||
|
Cash paid for interest
|
$
|
1,739
|
|
|
$
|
1,667
|
|
|
Conversion of accrued interest to notes payable
|
$
|
838
|
|
|
$
|
805
|
|
|
Property acquired under capital lease
|
$
|
—
|
|
|
$
|
70
|
|
|
•
|
Limited cash receipts from sales of OMIDRIA. Even though we have received an extension of transitional pass-through reimbursement for OMIDRIA for a period of two years beginning October 1, 2018, we are unable at this time to predict accurately revenue from sales of OMIDRIA once transitional pass-through reimbursement begins. In addition, sales of OMIDRIA are generally made with 90-day collection terms and, therefore, minimal OMIDRIA cash receipts were included for this exercise prior to January 2019;
|
|
•
|
No additional draws on our CRG debt facility. As disclosed in Note 6, we are in compliance with all covenants under our CRG Loan Agreement and have requested the additional
$45.0 million
that is available to us through May 20, 2018 subject only to customary closing conditions. However, given the existence of customary closing conditions, the draw on this facility was not considered for purposes of this exercise; and
|
|
•
|
No public or private equity transactions or partnering revenues can be considered for purposes of this exercise in the absence of any existing or committed arrangements to raise additional capital or of any existing or consummated partnerships.
|
|
|
March 31,
|
||||
|
|
2018
|
|
2017
|
||
|
Outstanding options to purchase common stock
|
9,640,452
|
|
|
10,924,062
|
|
|
Outstanding warrants to purchase common stock
|
100,602
|
|
|
100,602
|
|
|
Total
|
9,741,054
|
|
|
11,024,664
|
|
|
|
March 31,
2018 |
|
December 31,
2017 |
||||
|
|
(In thousands)
|
||||||
|
Trade receivables, net
|
$
|
49
|
|
|
$
|
17,079
|
|
|
Sublease and other receivables
|
133
|
|
|
65
|
|
||
|
Total accounts receivables net
|
$
|
182
|
|
|
$
|
17,144
|
|
|
|
March 31, 2018
|
||||||||||||||
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
|
|
(In thousands)
|
||||||||||||||
|
Assets:
|
|
|
|
|
|
|
|
||||||||
|
Money-market funds classified as non-current restricted cash and investments
|
$
|
5,835
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,835
|
|
|
Money-market funds classified as short-term investments
|
71,625
|
|
|
—
|
|
|
—
|
|
|
71,625
|
|
||||
|
Total
|
$
|
77,460
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
77,460
|
|
|
|
December 31, 2017
|
||||||||||||||
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
|
|
(In thousands)
|
||||||||||||||
|
Assets:
|
|
|
|
|
|
|
|
||||||||
|
Money-market funds classified as non-current restricted cash and investments
|
$
|
5,835
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
5,835
|
|
|
Money-market funds classified as short-term investments
|
80,355
|
|
|
—
|
|
|
—
|
|
|
80,355
|
|
||||
|
Total
|
$
|
86,190
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
86,190
|
|
|
|
March 31,
2018 |
|
December 31,
2017 |
||||
|
|
(In thousands)
|
||||||
|
Contract research and development
|
$
|
4,763
|
|
|
$
|
4,251
|
|
|
Employee compensation
|
3,727
|
|
|
2,178
|
|
||
|
Sales rebates, fees and discounts
|
1,825
|
|
|
6,561
|
|
||
|
Consulting and professional fees
|
1,494
|
|
|
1,758
|
|
||
|
Clinical trials
|
1,118
|
|
|
1,026
|
|
||
|
ASC/hospital product return liability
|
—
|
|
|
2,350
|
|
||
|
Other accruals
|
1,007
|
|
|
1,002
|
|
||
|
Total accrued liabilities
|
$
|
13,934
|
|
|
$
|
19,126
|
|
|
|
March 31,
2018 |
|
December 31, 2017
|
||||
|
|
(In thousands)
|
||||||
|
Notes payable
|
$
|
84,669
|
|
|
$
|
83,831
|
|
|
Lender facility fee payable upon maturity
|
4,233
|
|
|
4,192
|
|
||
|
Lease financing obligations
|
1,180
|
|
|
1,300
|
|
||
|
Notes payable, facility fee and lease financing obligations
|
90,082
|
|
|
89,323
|
|
||
|
Unamortized debt discount
|
(3,400
|
)
|
|
(3,527
|
)
|
||
|
Unamortized debt issuance costs
|
(1,132
|
)
|
|
(1,189
|
)
|
||
|
Current portion of lease financing obligations
|
(513
|
)
|
|
(490
|
)
|
||
|
Non-current portion of notes payable and lease financing obligations, net
|
$
|
85,037
|
|
|
$
|
84,117
|
|
|
|
Three Months Ended
March 31, |
||||||
|
|
2018
|
|
2017
|
||||
|
|
(In thousands)
|
||||||
|
Research and development
|
$
|
1,200
|
|
|
$
|
1,474
|
|
|
Selling, general and administrative
|
1,766
|
|
|
1,802
|
|
||
|
Total
|
$
|
2,966
|
|
|
$
|
3,276
|
|
|
|
Three Months Ended
March 31, |
||||||
|
|
2018
|
|
2017
|
||||
|
Estimated weighted-average fair value
|
$
|
9.79
|
|
|
$
|
7.64
|
|
|
Weighted-average assumptions
|
|
|
|
||||
|
Expected volatility
|
76
|
%
|
|
75
|
%
|
||
|
Expected term, in years
|
6.1
|
|
|
6.0
|
|
||
|
Risk-free interest rate
|
2.54
|
%
|
|
2.06
|
%
|
||
|
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
||
|
|
Options
Outstanding
|
|
Weighted-
Average
Exercise
Price per
Share
|
|
Remaining
Contractual Life
(In years)
|
|
Aggregate
Intrinsic
Value
(In thousands)
|
|||||
|
Balance at December 31, 2017
|
9,657,259
|
|
|
$
|
10.39
|
|
|
|
|
|
||
|
Granted
|
80,550
|
|
|
14.49
|
|
|
|
|
|
|||
|
Exercised
|
(75,616
|
)
|
|
9.09
|
|
|
|
|
|
|||
|
Forfeited
|
(21,741
|
)
|
|
15.80
|
|
|
|
|
|
|
||
|
Balance at March 31, 2018
|
9,640,452
|
|
|
$
|
10.42
|
|
|
6.57
|
|
$
|
13,760
|
|
|
Vested and expected to vest at March 31, 2018
|
9,373,849
|
|
|
$
|
10.36
|
|
|
6.50
|
|
$
|
13,687
|
|
|
Exercisable at March 31, 2018
|
7,095,978
|
|
|
$
|
9.68
|
|
|
5.81
|
|
$
|
13,056
|
|
|
•
|
MASP-2 - OMS721
. OMS721 is our lead human monoclonal antibody targeting mannan-binding lectin-associated serine protease-2, or MASP-2, the effector enzyme of the lectin pathway of the complement system. The current development focus for OMS721 is diseases in which the lectin pathway has been shown to contribute to significant tissue injury and pathology. These diseases are typically characterized by significant end organ injuries, such as kidney or central nervous system injury, when not treated. Phase 3 clinical programs are underway for OMS721 in HSCT-TMA, in IgA nephropathy, and in atypical hemolytic uremic syndrome, or aHUS. In addition, we have continued to enroll patients in our ongoing OMS721 Phase 2 IgA nephropathy clinical trial and in our OMS721 Phase 2 clinical trial in patients with TMAs. We are also developing small-molecule inhibitors of MASP-2 for oral administration that we are targeting for clinical trials in 2020.
|
|
•
|
HSCT-TMA: In the U.S., OMS721 has received from the FDA (1) breakthrough therapy designation in patients who have persistent TMA despite modification of immunosuppressive therapy and (2) orphan drug
|
|
•
|
IgA nephropathy: In the U.S., OMS721 has received from the FDA (1) breakthrough therapy designation for the treatment of IgA nephropathy and (2) and orphan drug designation in IgA nephropathy. In Europe, OMS721 has received from the EMA orphan drug designation in the treatment of IgA nephropathy, and we are pursuing Priority Medicines, or PRIME, designation from the EMA in this indication.
|
|
•
|
aHUS: In the U.S., OMS721 has received from the FDA (1) fast-track designation for the treatment of patients with aHUS and (2) orphan drug designation for the prevention (inhibition) of complement-mediated TMAs, which includes aHUS.
|
|
•
|
PDE10 - OMS824.
In our OMS824 program, we continue to advance our phosphodiesterase 10, or PDE10, inhibitors for treatment of neurological disorders. The FDA has approved our conducting clinical trials with our lead candidate subject to dosing limitations pending further discussions potentially to remove those limitations. Given the dosing limitations, we are currently focused on assessing the relative advantages of a number of our back-up compounds.
|
|
•
|
PPARγ - OMS405
. In our peroxisome proliferator-activated receptor gamma, or PPARγ, program, Phase 2 clinical trials have been conducted by our collaborators to evaluate a PPARγ agonist, alone or in combination with other agents, and have yielded positive data in the treatment of addiction to heroin and to nicotine. We have also reported positive results (
i.e.
, decreased craving and protection of brain white matter) from a Phase 2 clinical trial conducted by an independent investigator evaluating the effects of a PPARγ agonist in patients with cocaine use disorder.
|
|
•
|
PDE7 - OMS527.
In our phosphodiesterase 7, or PDE7, program, we are developing proprietary compounds to treat addiction and compulsive disorders as well as movement disorders. We have selected nicotine addiction as the initial indication and have completed toxicology studies intended to support the submission of a Clinical Trial Application, or CTA, in the EU and subsequent clinical trials. We currently expect to submit a CTA for OMS527 and begin our Phase 1 clinical trial by mid-2018.
|
|
•
|
MASP-3 - OMS906
. In our mannan-binding lectin-associated serine protease-3, or MASP-3 program, we are developing MASP-3 inhibitors for the treatment of disorders related to the alternative pathway of the complement system. In preparation for clinical trials, the manufacturing scale-up process is underway for a MASP-3 inhibitor antibody and we are currently targeting paroxysmal nocturnal hemoglobinuria, or PNH, as the first clinical indication for OMS906. We are currently planning for clinical trials to begin in late 2019 or early 2020. We are also developing small-molecule inhibitors of MASP-3.
|
|
•
|
GPCR Platform and Programs
. We have developed a proprietary cellular redistribution assay, or CRA, which we use in a high-throughput manner to identify synthetic ligands, including antagonists, agonists and inverse agonists, that bind to and affect the function of orphan GPCRs. We are conducting
in vitro
and
in vivo
preclinical efficacy studies and optimizing compounds for a number of targets including: GPR151, linked to schizophrenia and cognition; GPR161, which is associated with triple negative breast cancer and various sarcomas; GPR174, which appears to be involved in the modulation of the immune system and, in particular, increases cytokine production and inhibits production of regulatory T cells and checkpoint molecules, all of which are known to be important in cancer, in autoimmune disease, such as multiple sclerosis, and in organ transplantation; and OPN4, linked to seasonal affective disorder, mood disorders, sleep disorders and photophobia.
|
|
•
|
Antibody Platform.
Our proprietary
ex vivo
platform for the discovery of novel, high-affinity monoclonal antibodies, which was in-licensed from the University of Washington and then further developed by our scientists, utilizes a chicken B-cell lymphoma cell line. Using our platform and other know-how and techniques, we have generated antibodies to several clinically significant targets, including highly potent antibodies against MASP-3 and MASP-1.
|
|
|
Three Months Ended
March 31, |
||||||
|
|
2018
|
|
2017
|
||||
|
|
(In thousands)
|
||||||
|
Product sales, net
|
$
|
1,588
|
|
|
$
|
12,257
|
|
|
|
Chargebacks and Rebates
|
|
Distribution Fees and Product Return Allowances
|
|
Total
|
||||||
|
|
(In thousands)
|
||||||||||
|
Balance as of December 31, 2017
|
$
|
5,724
|
|
|
$
|
3,373
|
|
|
$
|
9,097
|
|
|
Provisions
|
322
|
|
|
323
|
|
|
645
|
|
|||
|
Payments
|
(5,401
|
)
|
|
(2,170
|
)
|
|
(7,571
|
)
|
|||
|
Balance as of March 31, 2018
|
$
|
645
|
|
|
$
|
1,526
|
|
|
$
|
2,171
|
|
|
|
Three Months Ended
March 31, |
||||||
|
|
2018
|
|
2017
|
||||
|
|
(In thousands)
|
||||||
|
Direct external expenses:
|
|
||||||
|
Clinical research and development:
|
|
|
|
||||
|
MASP-2 Program - OMS721
|
$
|
7,929
|
|
|
$
|
3,850
|
|
|
OMIDRIA - Ophthalmology
|
609
|
|
|
1,035
|
|
||
|
Other clinical programs
|
210
|
|
|
55
|
|
||
|
Total clinical research and development
|
8,748
|
|
|
4,940
|
|
||
|
Preclinical research and development
|
1,632
|
|
|
670
|
|
||
|
Total direct external expenses
|
10,380
|
|
|
5,610
|
|
||
|
|
|
|
|
||||
|
Internal, overhead and other expenses
|
6,560
|
|
|
5,156
|
|
||
|
Stock-based compensation expense
|
1,200
|
|
|
1,474
|
|
||
|
Total research and development expenses
|
$
|
18,140
|
|
|
$
|
12,240
|
|
|
|
Three Months Ended
March 31, |
||||||
|
|
2018
|
|
2017
|
||||
|
|
(In thousands)
|
||||||
|
Selling, general and administrative expenses, excluding stock-based compensation expense
|
$
|
9,168
|
|
|
$
|
10,669
|
|
|
Stock-based compensation expense
|
1,766
|
|
|
1,802
|
|
||
|
Total selling, general and administrative expenses
|
$
|
10,934
|
|
|
$
|
12,471
|
|
|
|
Three Months Ended
March 31, |
||||||
|
|
2018
|
|
2017
|
||||
|
|
(In thousands)
|
||||||
|
Interest expense
|
$
|
2,825
|
|
|
$
|
2,663
|
|
|
|
Three Months Ended
March 31, |
||||||
|
|
2018
|
|
2017
|
||||
|
|
(In thousands)
|
||||||
|
Selected cash flow data
|
|
|
|
||||
|
Cash provided by (used in):
|
|
|
|
||||
|
Operating activities
|
$
|
(11,296
|
)
|
|
$
|
(12,702
|
)
|
|
Investing activities
|
8,547
|
|
|
10,664
|
|
||
|
Financing activities
|
544
|
|
|
1,096
|
|
||
|
•
|
Revenue recognition;
|
|
•
|
Research and development expenses, primarily clinical trial expenses and manufacturing of drug product and clinical drug supply; and
|
|
•
|
Stock-based compensation.
|
|
•
|
pricing, coverage and reimbursement policies of government and private payers such as Medicare, Medicaid, the VA, group purchasing organizations, insurance companies, health maintenance organizations and other plan administrators;
|
|
•
|
a lack of acceptance by physicians, patients and other members of the healthcare community;
|
|
•
|
the availability, relative price and efficacy of the product as compared to alternative treatment options or branded, compounded or generic competing products;
|
|
•
|
an unknown safety risk;
|
|
•
|
the failure to enter into and maintain acceptable partnering arrangements for marketing and distribution of OMIDRIA outside of the U.S.;
|
|
•
|
changed or increased regulatory restrictions in the U.S., EU and/or other foreign territories; and
|
|
•
|
a lack of adequate financial or other resources.
|
|
•
|
the level and timing of commercial sales of OMIDRIA, as well as our product candidates if and when approved or commercialized;
|
|
•
|
the extent of coverage and reimbursement for OMIDRIA;
|
|
•
|
the amount of OMIDRIA chargebacks, rebates and product returns;
|
|
•
|
the extent of any payments received from collaboration arrangements and development funding as well as the achievement of development and clinical milestones under collaboration and license agreements that we may enter into from time to time and that may vary significantly from quarter to quarter; and
|
|
•
|
the timing, cost and level of investment in our research and development activities as well as expenditures we will or may incur to acquire or develop additional technologies, products and product candidates.
|
|
•
|
initiate and conduct clinical trials for our programs and product candidates;
|
|
•
|
continue OMIDRIA sales and marketing;
|
|
•
|
continue research and development in our programs;
|
|
•
|
make principal, interest and fee payments under the CRG Loan Agreement; and
|
|
•
|
commercialize and launch product candidates for which we may receive regulatory approval.
|
|
•
|
reduced protection for intellectual property rights;
|
|
•
|
unexpected changes in tariffs, trade barriers and regulatory requirements;
|
|
•
|
economic weakness, including inflation, or political instability in particular foreign economies and markets;
|
|
•
|
foreign currency fluctuations and other obligations incident to doing business in another country; and
|
|
•
|
business interruptions resulting from geopolitical actions, including war and terrorism or natural disasters including earthquakes, typhoons, floods and fires.
|
|
•
|
discussions with the FDA, the EMA or other foreign authorities regarding the scope or design of our clinical trials;
|
|
•
|
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;
|
|
•
|
delays in enrolling patients into clinical trials for any reason including disease severity, trial protocol design, study eligibility criteria, patient population size (
e.g.
, for orphan diseases or for some pediatric indications), proximity and/or availability of clinical trial sites for prospective patients, availability of competing therapies and clinical trials, regional differences in diagnosis and treatment, perceived risks and benefits of the product or product candidate, physician patient referral practices or the ability to monitor patients adequately before and after treatment;
|
|
•
|
lower than anticipated retention rates of patients in clinical trials;
|
|
•
|
the need to repeat or conduct additional clinical trials as a result of inconclusive or negative results, failure to replicate positive early clinical data in subsequent clinical trials, failure to deliver an efficacious dose of a product candidate, poorly executed testing, a failure of a clinical site to adhere to the clinical protocol, an unacceptable study design or other problems;
|
|
•
|
adverse findings in clinical or nonclinical studies related to the safety of our product candidates in humans;
|
|
•
|
an insufficient supply of product candidate materials or other materials necessary to conduct our clinical trials;
|
|
•
|
the need to qualify new suppliers of product candidate materials for FDA and foreign regulatory approval;
|
|
•
|
an unfavorable inspection or review by the FDA or other regulatory authority of a clinical trial site or records of any clinical investigation;
|
|
•
|
the occurrence of unacceptable drug-related side effects or adverse events experienced by participants in our clinical trials;
|
|
•
|
the suspension by a regulatory agency of a trial put on a clinical hold; or
|
|
•
|
the amendment of clinical trial protocols to reflect changes in regulatory requirements and guidance or other reasons as well as subsequent re-examination of amendments of clinical trial protocols by institutional review boards or ethics committees.
|
|
•
|
failure to conduct the clinical trial in accordance with regulatory requirements or our clinical protocols;
|
|
•
|
inspection of the clinical trial operations or trial sites by the FDA or other regulatory authorities resulting in the imposition of a clinical hold;
|
|
•
|
the failure to remove a clinical hold in a timely manner (which we cannot predict with certainty), if at all;
|
|
•
|
unforeseen safety issues or any determination that a trial presents unacceptable health risks;
|
|
•
|
inability to deliver an efficacious dose of a product candidate; or
|
|
•
|
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 CROs and other third parties.
|
|
•
|
we may not be able to generate sufficient data to support full patent applications that protect the entire breadth of developments in one or more of our programs, including our GPCR program;
|
|
•
|
it is possible that one or more of our pending patent applications will not become an issued patent or, if issued, that the patent(s) will be sufficient to protect our technology, provide us with a basis for commercially viable products or provide us with any competitive advantages;
|
|
•
|
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; or
|
|
•
|
if issued, the patents under which we hold rights may not be valid or enforceable.
|
|
Exhibit
Number
|
Description
|
|
4.1(1)
|
|
|
10.1(2)
|
|
|
12.1
|
|
|
31.1
|
|
|
31.2
|
|
|
32.1
|
|
|
32.2
|
|
|
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 Label Linkbase Document
|
|
101.PRE
|
XBRL Taxonomy Extension Presentation Linkbase Document
|
|
(1)
|
Incorporated by reference to Exhibit 10.2 of the registrant’s Current Report on Form 8-K filed on April 13, 2018 (File No. 001-34475).
|
|
(2)
|
Incorporated by reference to Exhibit 10.1 of the registrant’s Current Report on Form 8-K filed on April 13, 2018 (File No. 001-34475).
|
|
|
OMEROS CORPORATION
|
|
|
|
|
Dated: May 10, 2018
|
/s/ Gregory A. Demopulos
|
|
|
Gregory A. Demopulos, M.D.
|
|
|
President, Chief Executive Officer and Chairman of the Board of Directors
|
|
|
|
|
Dated: May 10, 2018
|
/s/ Michael A. Jacobsen
|
|
|
Michael A. Jacobsen
|
|
|
Vice President, Finance, Chief Accounting Officer and Treasurer
|
No information found
* THE VALUE IS THE MARKET VALUE AS OF THE LAST DAY OF THE QUARTER FOR WHICH THE 13F WAS FILED.
| FUND | NUMBER OF SHARES | VALUE ($) | PUT OR CALL |
|---|
| DIRECTORS | AGE | BIO | OTHER DIRECTOR MEMBERSHIPS |
|---|
No information found
No Customers Found
No Suppliers Found
Price
Yield
| Owner | Position | Direct Shares | Indirect Shares |
|---|