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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¨
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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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¨
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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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•
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our ability to receive regulatory approval for our New Drug Application, or NDA, for the commercialization of OMS302 in the United States in 2014;
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•
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our ability to submit a Marketing Authorization Application, or MAA, for OMS302 during the third quarter of 2013 and to subsequently receive regulatory approval for the commercialization of OMS302 in the European Union in 2014;
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•
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our ability to successfully complete our additional Phase 3 clinical trial for OMS302 in patients that have a history of using alpha adrenergic antagonists and our Phase 1 clinical trials for OMS824 and OMS721;
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•
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our ability to initiate additional Phase 3 clinical trials for OMS103HP;
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•
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our ability to initiate a clinical trial for our PDE7 program in 2014;
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•
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our ability to access the capital markets, including under our at-the-market equity facility with MLV & Co. LLC, or MLV;
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•
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our expectations regarding the clinical benefits of our products;
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•
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our expectation that 2014 is the earliest year in which any of our products will be commercially available or generate revenue;
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•
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our anticipation that we will rely on contract manufacturers to develop and manufacture our products for commercial sale;
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•
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our ability to enter into acceptable arrangements with potential corporate partners;
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•
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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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•
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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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•
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our involvement in potential claims, legal proceedings and administrative actions, the expected course and costs of existing claims, legal proceedings and administrative actions, and the potential outcomes and effects of both existing and potential claims, legal proceedings and administrative actions on our business, prospects, financial condition and results of operations; and
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•
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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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June 30,
2013 |
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December 31,
2012 |
||||
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(unaudited)
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||||
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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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1,716
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$
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1,520
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Short-term investments
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18,346
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20,830
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Grant and other receivables
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715
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1,934
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Prepaid expenses and other current assets
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494
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416
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Total current assets
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21,271
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24,700
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Property and equipment, net
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981
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1,037
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Restricted cash
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679
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|
|
679
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Other assets
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127
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|
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159
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Total assets
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$
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23,058
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$
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26,575
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Liabilities and shareholders’ equity
|
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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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4,253
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$
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2,632
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Accrued expenses
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4,162
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4,757
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Deferred revenue
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—
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970
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Current portion of notes payable, net of discount
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2,485
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—
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Total current liabilities
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10,900
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8,359
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Notes payable, net of current portion and discount
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17,809
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20,103
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Deferred rent, net of current portion
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6,605
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4,644
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Commitments and contingencies (Note 8)
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Shareholders’ equity:
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Preferred stock, par value $0.01 per share:
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Authorized shares—20,000,000 at June 30, 2013 (unaudited) and December 31, 2012;
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Issued and outstanding shares—none
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—
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—
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Common stock, par value $0.01 per share:
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Authorized shares—150,000,000 at June 30, 2013 (unaudited) and December 31, 2012;
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Issued and outstanding shares—29,832,771 and 25,897,483 at June 30, 2013 (unaudited) and December 31, 2012, respectively
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298
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259
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Additional paid-in capital
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226,104
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207,787
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Accumulated deficit
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(238,658
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)
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(214,577
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)
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Total shareholders’ deficit
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(12,256
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)
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(6,531
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)
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Total liabilities and shareholders’ equity
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$
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23,058
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$
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26,575
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Three Months Ended
June 30, |
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Six Months Ended
June 30, |
||||||||||||
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2013
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2012
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2013
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2012
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||||||||
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Revenue
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$
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140
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$
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1,526
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$
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1,235
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$
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3,022
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Operating expenses:
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Research and development
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9,564
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7,558
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16,691
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14,804
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Selling, general and administrative
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3,736
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2,212
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7,724
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4,534
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||||
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Total operating expenses
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13,300
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9,770
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24,415
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19,338
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||||
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Loss from operations
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(13,160
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)
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(8,244
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)
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(23,180
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)
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(16,316
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)
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||||
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Investment income
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2
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6
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8
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18
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||||
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Interest expense
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(589
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)
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(453
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)
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(1,176
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)
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(947
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)
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||||
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Other income (expense), net
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155
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|
152
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267
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(189
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)
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||||
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Net loss
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$
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(13,592
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)
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$
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(8,539
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)
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$
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(24,081
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)
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$
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(17,434
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)
|
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Comprehensive loss
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$
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(13,592
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)
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$
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(8,539
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)
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$
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(24,081
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)
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$
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(17,434
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)
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Basic and diluted net loss per share
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$
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(0.48
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)
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$
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(0.38
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)
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$
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(0.89
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)
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|
$
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(0.78
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)
|
|
Weighted-average shares used to compute basic and diluted net loss per share
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28,199,739
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22,466,540
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27,053,946
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22,450,722
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|
||||
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|
Six months ended June 30,
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||||||
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|
2013
|
|
2012
|
||||
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Operating activities
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|
|
|
||||
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Net loss
|
$
|
(24,081
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)
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|
$
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(17,434
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)
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
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|
||||
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Depreciation and amortization
|
145
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165
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|
||
|
Stock-based compensation expense
|
2,153
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|
|
1,700
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|
||
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Non-cash interest expense
|
242
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|
|
200
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|
||
|
Warrant modification expense
|
41
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|
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511
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|
||
|
Changes in operating assets and liabilities:
|
|
|
|
||||
|
Grant and other receivables
|
1,219
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|
|
108
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|
||
|
Prepaid expenses and other current and noncurrent assets
|
(72
|
)
|
|
(378
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)
|
||
|
Accounts payable and accrued expenses
|
1,001
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|
|
(62
|
)
|
||
|
Deferred Offering Costs
|
—
|
|
|
(235
|
)
|
||
|
Deferred revenue
|
(970
|
)
|
|
(1,950
|
)
|
||
|
Other Liabilities
|
1,961
|
|
|
3,009
|
|
||
|
Net cash used in operating activities
|
(18,361
|
)
|
|
(14,366
|
)
|
||
|
Investing activities
|
|
|
|
||||
|
Purchases of property and equipment
|
(89
|
)
|
|
(145
|
)
|
||
|
Purchases of investments
|
(19,617
|
)
|
|
—
|
|
||
|
Proceeds from the sale of investments
|
22,101
|
|
|
20,565
|
|
||
|
Net cash provided by investing activities
|
2,395
|
|
|
20,420
|
|
||
|
Financing activities
|
|
|
|
||||
|
Proceeds from issuance of common stock upon direct offering
|
16,120
|
|
|
—
|
|
||
|
Payments on notes payable
|
—
|
|
|
(3,031
|
)
|
||
|
Proceeds from issuance of common stock upon exercise of stock options
|
42
|
|
|
240
|
|
||
|
Net cash provided by (used in) financing activities
|
16,162
|
|
|
(2,791
|
)
|
||
|
Net increase in cash and cash equivalents
|
196
|
|
|
3,263
|
|
||
|
Cash and cash equivalents at beginning of period
|
1,520
|
|
|
4,005
|
|
||
|
Cash and cash equivalents at end of period
|
$
|
1,716
|
|
|
$
|
7,268
|
|
|
Supplemental cash flow information
|
|
|
|
||||
|
Cash paid for interest
|
$
|
778
|
|
|
$
|
769
|
|
|
Reduction of equipment cost basis due to assets purchased with grant funding
|
$
|
—
|
|
|
$
|
59
|
|
|
|
June 30,
|
||||
|
|
2013
|
|
2012
|
||
|
Outstanding options to purchase common stock
|
5,308,861
|
|
|
4,132,858
|
|
|
Warrants to purchase common stock
|
609,016
|
|
|
609,016
|
|
|
Total
|
5,917,877
|
|
|
4,741,874
|
|
|
|
June 30, 2013
|
||||||||||||||
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
|
|
(In thousands)
|
||||||||||||||
|
Assets:
|
|
|
|
|
|
|
|
||||||||
|
Money-market funds classified as cash equivalents
|
$
|
19
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
19
|
|
|
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
|
18,346
|
|
|
—
|
|
|
—
|
|
|
18,346
|
|
||||
|
Total
|
$
|
19,237
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
19,237
|
|
|
|
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
|
|
|
|
June 30,
2013 |
|
December 31,
2012 |
||||
|
|
(In thousands)
|
||||||
|
Contract Research
|
$
|
922
|
|
|
$
|
1,447
|
|
|
Legal
|
779
|
|
|
323
|
|
||
|
Employee Compensation
|
605
|
|
|
458
|
|
||
|
Clinical Trials
|
174
|
|
|
1,842
|
|
||
|
Consulting & Professional Fees
|
373
|
|
|
252
|
|
||
|
Other Accruals
|
1,309
|
|
|
435
|
|
||
|
Accrued Expenses
|
$
|
4,162
|
|
|
$
|
4,757
|
|
|
•
|
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.
|
|
|
Three Months Ended
June 30,
|
|
Six Months Ended
June 30,
|
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
Estimated weighted-average fair value
|
$
|
3.57
|
|
|
$
|
7.09
|
|
|
$
|
3.57
|
|
|
$
|
3.28
|
|
|
Weighted-average assumptions
|
|
|
|
|
|
|
|
||||||||
|
Expected volatility
|
82
|
%
|
|
86
|
%
|
|
82
|
%
|
|
89
|
%
|
||||
|
Expected term, in years
|
5.5
|
|
|
5.5
|
|
|
5.5
|
|
|
5.7
|
|
||||
|
Risk-free interest rate
|
1.02
|
%
|
|
0.78
|
%
|
|
1.02
|
%
|
|
1.05
|
%
|
||||
|
Expected dividend yield
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
|
—
|
%
|
||||
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
|
(In thousands)
|
|
(In thousands)
|
||||||||||||
|
Research and development
|
$
|
566
|
|
|
$
|
285
|
|
|
$
|
1,147
|
|
|
$
|
853
|
|
|
Selling, general and administrative
|
494
|
|
|
284
|
|
|
1,006
|
|
|
847
|
|
||||
|
Total
|
$
|
1,060
|
|
|
$
|
569
|
|
|
$
|
2,153
|
|
|
$
|
1,700
|
|
|
|
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
|
25,000
|
|
|
5.30
|
|
|
|
|
|
|||
|
Exercised
|
(32,284
|
)
|
|
1.31
|
|
|
|
|
|
|||
|
Forfeited
|
(74,437
|
)
|
|
7.45
|
|
|
|
|
|
|||
|
Balance at June 30, 2013
|
5,308,861
|
|
|
$
|
5.18
|
|
|
6.76
|
|
$
|
7,650
|
|
|
Vested and expected to vest at June 30, 2013
|
5,142,695
|
|
|
$
|
5.09
|
|
|
6.70
|
|
$
|
7,604
|
|
|
Exercisable at June 30, 2013
|
3,540,828
|
|
|
$
|
3.87
|
|
|
5.75
|
|
$
|
7,191
|
|
|
•
|
employee and consultant-related expenses, which include salaries and benefits;
|
|
•
|
external research and development expenses incurred pursuant to agreements with third-party manufacturing organizations, clinical research organizations, or CROs, clinical trial sites, and collaborators or licensors;
|
|
•
|
facilities, depreciation and other allocated expenses, which include direct and allocated expenses for rent and maintenance of facilities and depreciation of leasehold improvements and equipment; and
|
|
•
|
third-party supplier expenses including laboratory and other supplies.
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
|
(In thousands)
|
|
(In thousands)
|
||||||||||||
|
Revenue
|
$
|
140
|
|
|
$
|
1,526
|
|
|
$
|
1,235
|
|
|
$
|
3,022
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
|
(In thousands)
|
|
(In thousands)
|
||||||||||||
|
Direct external expenses:
|
|
|
|
|
|
||||||||||
|
Clinical research and development:
|
|
|
|
|
|
|
|
||||||||
|
OMS302
|
$
|
1,428
|
|
|
$
|
2,170
|
|
|
$
|
2,315
|
|
|
$
|
3,818
|
|
|
OMS103HP
|
102
|
|
|
915
|
|
|
368
|
|
|
1,905
|
|
||||
|
OMS824
|
1,583
|
|
|
—
|
|
|
2,318
|
|
|
—
|
|
||||
|
Other clinical programs
|
8
|
|
|
39
|
|
|
18
|
|
|
52
|
|
||||
|
Total clinical research and development
|
3,121
|
|
|
3,124
|
|
|
5,019
|
|
|
5,775
|
|
||||
|
Preclinical research and development
|
2,372
|
|
|
1,723
|
|
|
3,612
|
|
|
3,136
|
|
||||
|
Total direct external expenses
|
5,493
|
|
|
4,847
|
|
|
8,631
|
|
|
8,911
|
|
||||
|
Internal, overhead and other expenses
|
3,505
|
|
|
2,426
|
|
|
6,913
|
|
|
5,040
|
|
||||
|
Stock-based compensation expense
|
566
|
|
|
285
|
|
|
1,147
|
|
|
853
|
|
||||
|
Total research and development expenses
|
$
|
9,564
|
|
|
$
|
7,558
|
|
|
$
|
16,691
|
|
|
$
|
14,804
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
|
(In thousands)
|
|
(In thousands)
|
||||||||||||
|
Selling, general and administrative, excluding stock-based compensation expense
|
$
|
3,242
|
|
|
$
|
1,928
|
|
|
$
|
6,718
|
|
|
$
|
3,687
|
|
|
Stock-based compensation expense
|
494
|
|
|
284
|
|
|
1,006
|
|
|
847
|
|
||||
|
Total selling, general and administrative expenses
|
$
|
3,736
|
|
|
$
|
2,212
|
|
|
$
|
7,724
|
|
|
$
|
4,534
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
|
(In thousands)
|
|
(In thousands)
|
||||||||||||
|
Interest expense
|
$
|
589
|
|
|
$
|
453
|
|
|
$
|
1,176
|
|
|
$
|
947
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2013
|
|
2012
|
|
2013
|
|
2012
|
||||||||
|
|
(In thousands)
|
|
(In thousands)
|
||||||||||||
|
Other income (expense), net
|
$
|
155
|
|
|
$
|
152
|
|
|
$
|
267
|
|
|
$
|
(189
|
)
|
|
|
Six months ended June 30,
|
||||||
|
|
2013
|
|
2012
|
||||
|
|
(In thousands)
|
||||||
|
Selected cash flow data
|
|
|
|
||||
|
Cash provided by (used in):
|
|
|
|
||||
|
Operating activities
|
$
|
(18,361
|
)
|
|
$
|
(14,366
|
)
|
|
Investing activities
|
2,395
|
|
|
20,420
|
|
||
|
Financing activities
|
16,162
|
|
|
(2,791
|
)
|
||
|
•
|
the progress and results of our preclinical and clinical programs;
|
|
•
|
costs related to manufacturing services;
|
|
•
|
whether the hiring of a number of new employees to support our continued growth will occur at salary levels consistent with our estimates;
|
|
•
|
the terms and timing of payments of any collaborative or licensing agreements that we have or may establish;
|
|
•
|
the cost, timing and outcomes of the regulatory processes for our products;
|
|
•
|
the costs of commercialization activities, including product manufacturing, marketing, sales and distribution;
|
|
•
|
the cost of preparing, filing, prosecuting, defending and enforcing patent claims and other intellectual property rights;
|
|
•
|
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;
|
|
•
|
whether we receive grant funding for our programs;
|
|
•
|
the extent to which we raise capital by selling our stock through our at-the-market equity facility with MLV, under which MLV is required to use its commercially reasonable efforts to sell up to $49.3 million shares of our stock in accordance with our instructions;
|
|
•
|
the extent to which we otherwise access the capital markets;
|
|
•
|
the outcomes of our existing claims and legal proceedings; and
|
|
•
|
the amount of revenue we generate from the sale of our products, which revenue we do not expect until 2014 at the earliest.
|
|
•
|
our ability to provide acceptable evidence of safety and efficacy;
|
|
•
|
availability, relative cost and relative efficacy of alternative and competing treatments;
|
|
•
|
the effectiveness of our marketing and distribution strategy to, among others, hospitals, surgery centers, physicians and/or pharmacists;
|
|
•
|
prevalence of the condition for which the product is approved or frequency of the related surgical procedure;
|
|
•
|
acceptance by physicians of each product as a safe and effective treatment;
|
|
•
|
perceived advantages over alternative treatments;
|
|
•
|
relative convenience and ease of administration;
|
|
•
|
the availability of adequate reimbursement by third parties;
|
|
•
|
the frequency and severity of adverse side effects; and
|
|
•
|
publicity concerning our products or competing products and treatments.
|
|
•
|
our inability to recruit and retain adequate numbers of effective sales and marketing personnel;
|
|
•
|
the inability of sales personnel to sell our product(s) to adequate numbers of hospitals, surgery centers, physicians and/or pharmacists to purchase, use or prescribe any approved products;
|
|
•
|
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
|
|
•
|
unforeseen costs and expenses associated with creating an independent sales and marketing organization.
|
|
•
|
submit the MAA for OMS302 to the EMA and prepare for the product's potential commercialization;
|
|
•
|
continue the Phase 3 clinical program of OMS103HP for use in arthroscopic partial meniscectomy surgery;
|
|
•
|
continue the clinical development of OMS824 and OMS721;
|
|
•
|
continue our development efforts in our GPCR program to advance this program for potential partnering or for internal development of products targeting GPCRs;
|
|
•
|
scale-up and produce clinical and commercial supplies of products, and conduct clinical studies for our products, including for OMS302, OMS103HP, OMS824, OMS721, and products being developed in our PDE7 and Plasmin programs;
|
|
•
|
continue research and development in all of our programs;
|
|
•
|
make principal and interest payments when due under our debt facility with Oxford;
|
|
•
|
initiate and conduct clinical trials for other products;
|
|
•
|
make milestone payments to our collaborators; and
|
|
•
|
launch and commercialize any products for which we receive regulatory approval.
|
|
•
|
discussions with the FDA or comparable 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;
|
|
•
|
lower than anticipated retention rates of patients in clinical trials;
|
|
•
|
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;
|
|
•
|
an insufficient supply of product materials or other materials necessary to conduct our clinical trials;
|
|
•
|
the need to qualify new suppliers of product materials for FDA and foreign regulatory approval;
|
|
•
|
an unfavorable FDA inspection or review 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; or
|
|
•
|
the placement of a trial on a clinical hold.
|
|
•
|
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;
|
|
•
|
unforeseen safety issues or any determination that a trial presents unacceptable health risks; 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 contract research organizations, CROs, and other third parties.
|
|
•
|
we might not have been the first to make the inventions covered by any of our patents, if issued, or our pending patent applications;
|
|
•
|
we might not have been the first to file patent applications for these inventions;
|
|
•
|
others may independently develop similar or alternative technologies or products or duplicate any of our technologies or products;
|
|
•
|
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;
|
|
•
|
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;
|
|
•
|
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;
|
|
•
|
if issued, the patents under which we hold rights may not be valid or enforceable; or
|
|
•
|
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.
|
|
•
|
develop and market products that are less expensive or more effective than any future products that we may develop;
|
|
•
|
commercialize competing products before we can launch any products that we may develop;
|
|
•
|
operate larger research and development programs, possess commercial-scale manufacturing operations or have substantially greater financial resources than we do;
|
|
•
|
initiate or withstand substantial price competition more successfully than we can;
|
|
•
|
have greater success in recruiting skilled technical and scientific workers from the limited pool of available talent;
|
|
•
|
more effectively negotiate third-party licenses and strategic relationships; and
|
|
•
|
take advantage of acquisition or other opportunities more readily than we can.
|
|
•
|
restrictions on such products or manufacturing processes;
|
|
•
|
withdrawal of the products from the market;
|
|
•
|
voluntary or mandatory recalls;
|
|
•
|
fines;
|
|
•
|
suspension of regulatory approvals;
|
|
•
|
product seizures; or
|
|
•
|
injunctions or the imposition of civil or criminal penalties.
|
|
•
|
a covered benefit under its health plan;
|
|
•
|
safe, effective and medically necessary;
|
|
•
|
appropriate for the specific patient;
|
|
•
|
cost-effective; and
|
|
•
|
neither experimental nor investigational.
|
|
•
|
FDA or EMA actions related to our NDA submission and planned MAA submission for OMS302;
|
|
•
|
results from our clinical development programs, including the data from our ongoing clinical development programs evaluating OMS302, OMS103HP, OMS824 and OMS721;
|
|
•
|
FDA or international regulatory actions related to any of our other products;
|
|
•
|
announcements regarding the progress of our preclinical programs and our GPCR program;
|
|
•
|
failure of any of our products, if approved, to achieve commercial success;
|
|
•
|
quarterly variations in our results of operations or those of our competitors;
|
|
•
|
our ability to develop and market new and enhanced products on a timely basis;
|
|
•
|
announcements by us or our competitors of acquisitions, regulatory approvals, clinical milestones, new products, significant contracts, commercial relationships or capital commitments;
|
|
•
|
third-party coverage and reimbursement policies;
|
|
•
|
additions or departures of key personnel;
|
|
•
|
commencement of, or our involvement in, litigation;
|
|
•
|
our ability to meet our repayment and other obligations under our loan facility with Oxford, pursuant to which our outstanding principal balance was $20.0 million as of
June 30, 2013
;
|
|
•
|
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.
|
|
Exhibit
Number
|
Description
|
|
10.1*
|
Form of Subscription Agreement, dated May 9, 2013, between Omeros Corporation and each of the investors in the offering.
|
|
12.1
|
Ratio of Earnings to Fixed Charges
|
|
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
|
|
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
|
|
*
|
Incorporated by reference from the registrant’s Current Report on Form 8-K filed on May 10, 2013 (File No. 001-34475).
|
|
**
|
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.
|
|
|
OMEROS CORPORATION
|
|
|
|
|
Dated: August 9, 2013
|
/s/ Gregory A. Demopulos
|
|
|
Gregory A. Demopulos, M.D.
|
|
|
President, Chief Executive Officer
and Chairman of the Board of Directors
|
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 |
|---|