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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•
|
our plans for sales, marketing and distribution of OMIDRIA
®
(phenylephrine and ketorolac injection) 1%/0.3%;
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•
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our expectations regarding our product sales and our estimate regarding how long our existing cash, cash equivalents, short-term investments and revenues will be sufficient to fund our anticipated operating expenses, capital expenditures and interest and principal payments on our outstanding notes under our Loan and Security Agreement with Oxford Finance LLC and East West Bank;
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•
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our ability to raise additional capital through the capital markets, including under our at-the-market equity facility with JonesTrading Institutional Services LLC, 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 ability to forecast accurately wholesaler demand as well as our estimates of chargebacks and rebates, distribution fees and estimated product returns;
|
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•
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our expectations regarding the clinical, therapeutic and competitive benefits of OMIDRIA and our product candidates;
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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 and our expectations regarding product supply and manufacturing of OMIDRIA;
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•
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our ability to enter into acceptable arrangements with potential corporate partners, including with respect to OMIDRIA;
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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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our expectation that the OMIDRIAssure™ Reimbursement Services Program will increase patient access to OMIDRIA;
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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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when or whether the dosing limitations in our OMS824 program may be removed;
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•
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our ability to design and 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 and for OMS824;
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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 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;
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•
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our expectations regarding our OMS103 exclusive license agreement including, without limitation, the manufacturing and commercialization of OMS103 and the commencement and subsequent continuation of product sales on which we could receive royalty revenue; 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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June 30,
2016 |
|
December 31,
2015 |
||||
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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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4,589
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$
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1,365
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Short-term investments
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16,648
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26,898
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Receivables
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8,806
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|
6,517
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||
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Inventory
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1,780
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|
472
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|
||
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Prepaid expense
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2,282
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|
|
1,894
|
|
||
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Total current assets
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34,105
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|
|
37,146
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|
||
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Property and equipment, net
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1,251
|
|
|
951
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|
||
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Restricted cash and investments
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10,679
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|
|
10,679
|
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||
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Other assets
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73
|
|
|
219
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|
||
|
Total assets
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$
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46,108
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|
|
$
|
48,995
|
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|
|
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|
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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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5,420
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$
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6,428
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Accrued expenses
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10,452
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9,752
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Current portion of notes payable
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193
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73
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Total current liabilities
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16,065
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16,253
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Notes payable, net
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69,833
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49,769
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Deferred rent
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9,205
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9,207
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Commitments and contingencies (Note 8)
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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 June 30, 2016 and December 31, 2015
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|
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—
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Common stock, par value $0.01 per share, 150,000,000 shares authorized at June 30, 2016 and December 31, 2015; 39,277,231 and 38,040,891 issued and outstanding at June 30, 2016 and December 31, 2015, respectively
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393
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|
|
380
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Additional paid-in capital
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386,905
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376,528
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|
||
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Accumulated deficit
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(436,293
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)
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(403,142
|
)
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||
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Total shareholders’ deficit
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(48,995
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)
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|
(26,234
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)
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Total liabilities and shareholders’ deficit
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$
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46,108
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$
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48,995
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Three Months Ended
June 30, |
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Six Months Ended
June 30, |
||||||||||||
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2016
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2015
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2016
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2015
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||||||||
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Revenues
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Product sales, net
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$
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10,004
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$
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3,125
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$
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17,250
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$
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3,363
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Grant revenue
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—
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62
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|
173
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212
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||||
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Total revenue
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10,004
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3,187
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17,423
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3,575
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||||
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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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327
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365
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|
654
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376
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||||
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Research and development
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10,231
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10,900
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25,665
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20,218
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||||
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Selling, general and administrative
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10,375
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7,889
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21,485
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16,878
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||||
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Total costs and expenses
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20,933
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|
19,154
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|
47,804
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|
37,472
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||||
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Loss from operations
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(10,929
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)
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(15,967
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)
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(30,381
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)
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(33,897
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)
|
||||
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Interest expense
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(1,857
|
)
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|
(937
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)
|
|
(3,232
|
)
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(1,894
|
)
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||||
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Other income (expense), net
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174
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|
|
224
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|
|
462
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|
|
442
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|
||||
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Net loss
|
$
|
(12,612
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)
|
|
$
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(16,680
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)
|
|
$
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(33,151
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)
|
|
$
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(35,349
|
)
|
|
Comprehensive loss
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$
|
(12,612
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)
|
|
$
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(16,680
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)
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|
$
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(33,151
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)
|
|
$
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(35,349
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)
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|
Basic and diluted net loss per share
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$
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(0.32
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)
|
|
$
|
(0.44
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)
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$
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(0.86
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)
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|
$
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(0.95
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)
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|
Weighted-average shares used to compute basic and diluted net loss per share
|
39,178,547
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|
37,846,832
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38,747,816
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|
37,165,196
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|
||||
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|
Six Months Ended
June 30, |
||||||
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|
2016
|
|
2015
|
||||
|
Operating activities:
|
|
|
|
||||
|
Net loss
|
$
|
(33,151
|
)
|
|
$
|
(35,349
|
)
|
|
Adjustments to reconcile net loss to net cash used in operating activities:
|
|
|
|
||||
|
Depreciation and amortization
|
122
|
|
|
107
|
|
||
|
Stock-based compensation expense
|
7,031
|
|
|
4,898
|
|
||
|
Non-cash interest expense
|
684
|
|
|
442
|
|
||
|
Changes in operating assets and liabilities:
|
|
|
|
||||
|
Receivables
|
(2,289
|
)
|
|
(2,679
|
)
|
||
|
Inventory
|
(1,308
|
)
|
|
(65
|
)
|
||
|
Prepaid expenses and other assets
|
(242
|
)
|
|
(228
|
)
|
||
|
Accounts payable and accrued expenses
|
(268
|
)
|
|
(1,229
|
)
|
||
|
Deferred rent
|
(2
|
)
|
|
82
|
|
||
|
Net cash used in operating activities
|
(29,423
|
)
|
|
(34,021
|
)
|
||
|
Investing activities:
|
|
|
|
||||
|
Purchases and sales of property and equipment
|
(34
|
)
|
|
(114
|
)
|
||
|
Purchases of investments
|
(20,625
|
)
|
|
(79,403
|
)
|
||
|
Proceeds from the sale and maturities of investments
|
30,875
|
|
|
37,050
|
|
||
|
Net cash provided by (used in) investing activities
|
10,216
|
|
|
(42,467
|
)
|
||
|
Financing activities:
|
|
|
|
||||
|
Proceeds from issuance of common stock and pre-funded warrants, net
|
724
|
|
|
79,076
|
|
||
|
Proceeds from borrowings under notes payable, net
|
19,864
|
|
|
—
|
|
||
|
Payments on notes payable
|
(34
|
)
|
|
(2,342
|
)
|
||
|
Proceeds upon exercise of stock options and warrants
|
1,877
|
|
|
1,961
|
|
||
|
Net cash provided by financing activities
|
22,431
|
|
|
78,695
|
|
||
|
Net increase in cash and cash equivalents
|
3,224
|
|
|
2,207
|
|
||
|
Cash and cash equivalents at beginning of period
|
1,365
|
|
|
354
|
|
||
|
Cash and cash equivalents at end of period
|
$
|
4,589
|
|
|
$
|
2,561
|
|
|
Supplemental cash flow information
|
|
|
|
||||
|
Cash paid for interest
|
$
|
2,005
|
|
|
$
|
1,471
|
|
|
Issuance of warrants in connection with the Amendment to the Loan Agreement
|
$
|
758
|
|
|
$
|
—
|
|
|
Property acquired under capital lease
|
$
|
388
|
|
|
$
|
—
|
|
|
Prepaid expenses not yet paid
|
$
|
1,035
|
|
|
$
|
68
|
|
|
|
June 30,
|
||||
|
|
2016
|
|
2015
|
||
|
Outstanding options to purchase common stock
|
9,501,818
|
|
|
8,427,501
|
|
|
Warrants and pre-funded warrants to purchase common stock
|
100,602
|
|
|
1,149,249
|
|
|
Total
|
9,602,420
|
|
|
9,576,750
|
|
|
|
June 30, 2016
|
||||||||||||||
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
|
|
(In thousands)
|
||||||||||||||
|
Assets:
|
|
|
|
|
|
|
|
||||||||
|
Money-market funds classified as non-current restricted cash and investments
|
$
|
10,679
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
10,679
|
|
|
Money-market funds classified as short-term investments
|
16,648
|
|
|
—
|
|
|
—
|
|
|
16,648
|
|
||||
|
Total
|
$
|
27,327
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
27,327
|
|
|
|
December 31, 2015
|
||||||||||||||
|
|
Level 1
|
|
Level 2
|
|
Level 3
|
|
Total
|
||||||||
|
|
(In thousands)
|
||||||||||||||
|
Assets:
|
|
|
|
|
|
|
|
||||||||
|
Money-market funds classified as non-current restricted cash and investments
|
$
|
10,679
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
10,679
|
|
|
Money-market funds classified as short-term investments
|
26,898
|
|
|
—
|
|
|
—
|
|
|
26,898
|
|
||||
|
Total
|
$
|
37,577
|
|
|
$
|
—
|
|
|
$
|
—
|
|
|
$
|
37,577
|
|
|
|
June 30,
2016 |
|
December 31,
2015 |
||||
|
|
(In thousands)
|
||||||
|
Raw materials
|
$
|
101
|
|
|
$
|
93
|
|
|
Work-in-process
|
1,559
|
|
|
158
|
|
||
|
Finished goods
|
120
|
|
|
221
|
|
||
|
Total inventory
|
$
|
1,780
|
|
|
$
|
472
|
|
|
|
June 30,
2016 |
|
December 31,
2015 |
||||
|
|
(In thousands)
|
||||||
|
Consulting and professional fees
|
$
|
2,898
|
|
|
$
|
2,400
|
|
|
Employee compensation
|
2,729
|
|
|
2,590
|
|
||
|
Contract research and development
|
2,138
|
|
|
2,973
|
|
||
|
Other accruals
|
1,448
|
|
|
681
|
|
||
|
Clinical trials
|
1,239
|
|
|
1,108
|
|
||
|
Total accrued liabilities
|
$
|
10,452
|
|
|
$
|
9,752
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
|
(In thousands)
|
|
(In thousands)
|
||||||||||||
|
Research and development
|
$
|
1,219
|
|
|
$
|
1,229
|
|
|
$
|
3,374
|
|
|
$
|
2,554
|
|
|
Selling, general and administrative
|
1,391
|
|
|
1,151
|
|
|
3,657
|
|
|
2,344
|
|
||||
|
Total
|
$
|
2,610
|
|
|
$
|
2,380
|
|
|
$
|
7,031
|
|
|
$
|
4,898
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
Estimated weighted-average fair value
|
$
|
8.50
|
|
|
$
|
12.63
|
|
|
$
|
6.93
|
|
|
$
|
12.97
|
|
|
Weighted-average assumptions
|
|
|
|
|
|
|
|
||||||||
|
Expected volatility
|
74
|
%
|
|
69
|
%
|
|
74
|
%
|
|
70
|
%
|
||||
|
Expected term, in years
|
5.8
|
|
|
5.9
|
|
|
5.7
|
|
|
5.9
|
|
||||
|
Risk-free interest rate
|
1.37
|
%
|
|
1.71
|
%
|
|
1.40
|
%
|
|
1.61
|
%
|
||||
|
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, 2015
|
8,310,235
|
|
|
$
|
7.97
|
|
|
|
|
|
||
|
Granted
|
1,663,155
|
|
|
10.84
|
|
|
|
|
|
|||
|
Exercised
|
(422,525
|
)
|
|
4.42
|
|
|
|
|
|
|||
|
Forfeited
|
(49,047
|
)
|
|
14.02
|
|
|
|
|
|
|||
|
Balance at June 30, 2016
|
9,501,818
|
|
|
$
|
8.60
|
|
|
6.44
|
|
$
|
23,678
|
|
|
Vested and expected to vest at June 30, 2016
|
9,225,654
|
|
|
$
|
8.51
|
|
|
6.36
|
|
$
|
23,615
|
|
|
Exercisable at June 30, 2016
|
6,764,948
|
|
|
$
|
7.41
|
|
|
5.45
|
|
$
|
23,051
|
|
|
•
|
MASP-2 - OMS721
. OMS721, our lead mannan-binding lectin-associated serine protease-2, or MASP-2, antibody, is being developed for diseases of the lectin pathway, one of the principal complement activation pathways, which is believed to contribute to significant tissue injury and pathology. One group of such diseases is thrombotic microangiopathies, or TMAs, including atypical hemolytic uremic syndrome, or aHUS, thrombotic thrombocytopenic purpura, or TTP, and hematopoietic stem-cell transplant, or HSCT, -related TMA. We have a Phase 3 clinical program consisting of one single-arm (i.e., no control arm), open-label trial evaluating OMS721 in patients with newly diagnosed or ongoing aHUS and initiation of enrollment in this trial is planned for later this year. In July 2016, we announced that we received advice from the European Medicines Agency allowing us to use data from this single Phase 3 trial to also support a marketing approval application in the EU. We are also currently conducting two Phase 2 clinical programs, one in patients with TMAs (
i.e.
, HSCT-related TMA and TTP) as well as a second Phase 2 clinical program in patients with corticosteroid-dependent renal diseases, including immunoglobulin A, or IgA, nephropathy, membranous nephropathy, lupus nephritis and C3 glomerulopathy. Patient dosing in the Phase 2 renal disease clinical trial was initiated in April 2016.
|
|
•
|
PDE10 - OMS824 for Huntington’s disease and Schizophrenia.
OMS824, our lead phosphodiesterase 10, or PDE10, inhibitor, is in a Phase 2 clinical program for the treatment of Huntington’s disease, in which clinical trials are currently subject to dosing limitations, and a Phase 2 clinical program for schizophrenia, in which no clinical trials are currently active. The dosing limitations in our Phase 2 clinical trial in Huntington’s may potentially be removed pending generation, submission and FDA review of additional information. We are conducting nonclinical studies to generate additional data for further discussion with the FDA regarding the dosing limitations and are currently preparing for a re-designed Phase 2 clinical trial in patients with Huntington’s disease. As we announced in October 2014, clinical trials evaluating OMS824 in schizophrenia are suspended currently at the request of the FDA. Given that there was no active schizophrenia trial at the time of program suspension, the FDA will address the OMS824 schizophrenia program when we have a related trial protocol ready for initiation.
|
|
•
|
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, for treatment of addiction to opioids and to nicotine. Our collaborators are analyzing data from these trials and expect to present relevant information in manuscripts to be published at a later date.
|
|
•
|
OMS201-Urology.
OMS201, our PharmacoSurgery product candidate for use during urological procedures, including uroendoscopic procedures, completed a Phase 1/Phase 2 clinical trial in 2010 and is not currently in active clinical trials.
|
|
•
|
PDE7 - OMS527.
In our PDE7 program, we are developing proprietary compounds to treat addiction and compulsive disorders as well as movement disorders.
|
|
•
|
Plasmin - OMS616
. In our Plasmin program, we are advancing novel antifibrinolytic agents for the control of blood loss during surgery or resulting from trauma as well as for other hyperfibrinolytic states (e.g., liver disease).
|
|
•
|
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 August 2016, we announced results from our OMS906 complement program showing that OMS906 inhibited activation of the alternative pathway of complement and reduced both the incidence and severity of disease in a well-established animal model of arthritis. We are initiating the process of manufacturing scale-up of OMS906 in preparation for clinical trials.
|
|
•
|
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 vivo
preclinical efficacy studies and optimizing compounds for a number of targets including: GPR17, linked to myelin formation; GPR101, linked to appetite and eating disorders; GPR151, linked to schizophrenia and cognition; GPR161, which is associated with triple negative breast cancer; GPR183, linked to osteoporosis and to Epstein-Barr virus infections and related diseases; and GPR174, which appears to be involved in the modulation of regulatory T cells, or “T-regs,” known to be important in autoimmune disease, such as multiple sclerosis, and in cancer and organ transplantation.
|
|
•
|
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. We have generated antibodies to several clinically significant targets, including highly potent antibodies against MASP-3, and our platform continues to add to our pipeline antibodies against additional important targets.
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
|
(In thousands)
|
|
(In thousands)
|
||||||||||||
|
Product sales, net
|
$
|
10,004
|
|
|
$
|
3,125
|
|
|
$
|
17,250
|
|
|
$
|
3,363
|
|
|
Small Business Innovative Research Grants (SBIR)
|
—
|
|
|
62
|
|
|
173
|
|
|
212
|
|
||||
|
Total revenue
|
$
|
10,004
|
|
|
$
|
3,187
|
|
|
$
|
17,423
|
|
|
$
|
3,575
|
|
|
|
Chargebacks and Rebates
|
|
Distribution Fees and Product Return Allowances
|
|
Total
|
||||||
|
|
(In thousands)
|
||||||||||
|
Balance as of December 31, 2015
|
$
|
180
|
|
|
$
|
277
|
|
|
$
|
457
|
|
|
Provision related to current period sales
|
854
|
|
|
580
|
|
|
1,434
|
|
|||
|
Payments made/credits granted
|
(679
|
)
|
|
(389
|
)
|
|
(1,068
|
)
|
|||
|
Balance as of June 30, 2016
|
$
|
355
|
|
|
$
|
468
|
|
|
$
|
823
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
|
(In thousands)
|
|
(In thousands)
|
||||||||||||
|
Direct external expenses:
|
|
|
|
|
|
||||||||||
|
Clinical research and development:
|
|
|
|
|
|
|
|
||||||||
|
OMS721
|
$
|
2,701
|
|
|
$
|
3,152
|
|
|
$
|
8,697
|
|
|
$
|
4,394
|
|
|
OMIDRIA (OMS302)
|
684
|
|
|
974
|
|
|
1,949
|
|
|
1,727
|
|
||||
|
OMS824
|
53
|
|
|
518
|
|
|
325
|
|
|
1,051
|
|
||||
|
Other clinical programs
|
15
|
|
|
10
|
|
|
29
|
|
|
18
|
|
||||
|
Total clinical research and development
|
3,453
|
|
|
4,654
|
|
|
11,000
|
|
|
7,190
|
|
||||
|
Preclinical research and development
|
485
|
|
|
327
|
|
|
975
|
|
|
829
|
|
||||
|
Total direct external expenses
|
3,938
|
|
|
4,981
|
|
|
11,975
|
|
|
8,019
|
|
||||
|
|
|
|
|
|
|
|
|
||||||||
|
Internal, overhead and other expenses
|
5,074
|
|
|
4,690
|
|
|
10,316
|
|
|
9,645
|
|
||||
|
Stock-based compensation expense
|
1,219
|
|
|
1,229
|
|
|
3,374
|
|
|
2,554
|
|
||||
|
Total research and development expenses
|
$
|
10,231
|
|
|
$
|
10,900
|
|
|
$
|
25,665
|
|
|
$
|
20,218
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
|
(In thousands)
|
|
(In thousands)
|
||||||||||||
|
Selling, general and administrative expenses, excluding stock-based compensation expense
|
$
|
8,984
|
|
|
$
|
6,738
|
|
|
$
|
17,828
|
|
|
$
|
14,534
|
|
|
Stock-based compensation expense
|
1,391
|
|
|
1,151
|
|
|
3,657
|
|
|
2,344
|
|
||||
|
Total selling, general and administrative expenses
|
$
|
10,375
|
|
|
$
|
7,889
|
|
|
$
|
21,485
|
|
|
$
|
16,878
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
|
(In thousands)
|
|
(In thousands)
|
||||||||||||
|
Interest expense
|
$
|
1,857
|
|
|
$
|
937
|
|
|
$
|
3,232
|
|
|
$
|
1,894
|
|
|
|
Three Months Ended
June 30, |
|
Six Months Ended
June 30, |
||||||||||||
|
|
2016
|
|
2015
|
|
2016
|
|
2015
|
||||||||
|
|
(In thousands)
|
|
(In thousands)
|
||||||||||||
|
Other income (expense), net
|
$
|
174
|
|
|
$
|
224
|
|
|
$
|
462
|
|
|
$
|
442
|
|
|
|
Six Months Ended
June 30, |
||||||
|
|
2016
|
|
2015
|
||||
|
|
(In thousands)
|
||||||
|
Selected cash flow data
|
|
|
|
||||
|
Cash provided by (used in):
|
|
|
|
||||
|
Operating activities
|
$
|
(29,423
|
)
|
|
$
|
(34,021
|
)
|
|
Investing activities
|
10,216
|
|
|
(42,467
|
)
|
||
|
Financing activities
|
22,431
|
|
|
78,695
|
|
||
|
•
|
a lack of acceptance by physicians, patients, government and private payers and other members of the medical community;
|
|
•
|
our limited experience in marketing, selling and distributing OMIDRIA or any other product;
|
|
•
|
our limited experience managing third-party commercial manufacturing of OMIDRIA or any other product as well as our limited experience managing and maintaining a commercial sales organization;
|
|
•
|
pricing, reimbursement and coverage policies of government and private payers such as Medicare, Medicaid, the Department of Veterans Affairs, or VA, group purchasing organizations, insurance companies, health maintenance organizations and other plan administrators;
|
|
•
|
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 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, including following the expiration of pass-through reimbursement effective January 1, 2018, and 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.
|
|
•
|
continue OMIDRIA sales and marketing;
|
|
•
|
continue research and development in our programs;
|
|
•
|
make principal and interest payments under the Loan Agreement;
|
|
•
|
initiate and conduct clinical trials for our programs and product candidates; 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, which could result in increased operating expenses and reduced revenues, 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, 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; and
|
|
•
|
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; 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, or 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)
|
Form of Omeros Corporation Warrant to Purchase Common Stock
|
|
10.1(2)
|
First Amendment to Loan and Security Agreement between Omeros and Oxford Finance LLC, as collateral agent and as a lender, and East West Bank, as a lender, dated May 16, 2016
|
|
10.2(3)
|
Form of Secured Promissory Note issued by Omeros to Oxford Finance LLC and to East West Bank
|
|
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
|
|
(1)
|
Incorporated by reference to Exhibit 10.3 of the registrant’s Current Report on Form 8-K filed on May 19, 2016 (File No. 001-34475).
|
|
(2)
|
Incorporated by reference to Exhibit 10.1 of the registrant’s Current Report on Form 8-K filed on May 19, 2016 (File No. 001-34475).
|
|
(3)
|
Incorporated by reference to Exhibit 10.2 of the registrant’s Current Report on Form 8-K filed on May 19, 2016 (File No. 001-34475).
|
|
|
OMEROS CORPORATION
|
|
|
|
|
Dated: August 9, 2016
|
/s/ Gregory A. Demopulos
|
|
|
Gregory A. Demopulos, M.D.
|
|
|
President, Chief Executive Officer and Chairman of the Board of Directors
|
|
|
|
|
Dated: August 9, 2016
|
/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 |
|---|