Omeros Corporation Reports Second Quarter 2018 Financial Results
– Conference Call Today at
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2Q 2018 total and OMIDRIA® revenues were
$1.7 million , compared to$17.2 million in 2Q 2017; the decrease was due to the significantly reduced usage of OMIDRIA by ambulatory surgery centers (ASCs) and hospitals during the period (January 1, 2018 throughSeptember 30, 2018 ) in which transitional pass-through reimbursement for OMIDRIA is unavailable. Pass-through status for OMIDRIA will reinitiate onOctober 1, 2018 and is scheduled to remain in effect throughSeptember 30, 2020 . -
Net loss in 2Q 2018 was
$33.7 million , or$0.70 per share. Non-cash expenses for 2Q 2018 were$4.6 million , or$0.10 per share. -
At
June 30, 2018 , the company had cash, cash equivalents and short-term investments available for operations of$88.4 million . -
Successful meetings held with the
U.S. Food and Drug Administration (FDA ) and a European regulatory agency focused on pathways to accelerated, conditional and full approval for OMS721 in “high-risk” stem cell transplant-associated thrombotic microangiopathy. Interactions with U.S. and European regulatory agencies are ongoing and the company continues preparations for Biologics License Application (BLA) and Marketing Authorization Application (MAA) submissions. -
Settled patent infringement lawsuit against Lupin on favorable terms
in
May 2018 , and patent infringement lawsuit againstSandoz was dismissed inJuly 2018 becauseSandoz stipulated to no longer pursue its Abbreviated New Drug Application (ANDA) prior to OMIDRIA patent expiration in 2033, resolving all litigation with ANDA filers. -
In
July 2018 , the first patient was dosed in the Phase 1 clinical trial for Omeros’ lead phosphodiesterase 7 (PDE7) inhibitor OMS527. Dosing has been completed in the first two cohorts of this Phase 1 clinical trial and to date the drug remains well-tolerated.
“During the last quarter, we made significant strides across multiple
fronts,” said
Second Quarter and Recent Developments
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Developments regarding OMS721, Omeros’ lead human monoclonal antibody
in its mannan-binding lectin-associated serine protease-2 (MASP-2)
programs for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy (HSCT-TMA),
Immunoglobulin A (IgA) nephropathy, and atypical hemolytic uremic
syndrome (aHUS), include:
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The company recently held successful meetings with the
FDA and a European regulatory agency covering pathways to accelerated, conditional and full approval for OMS721 in “high-risk” HSCT-TMA. Interactions with U.S. and European regulatory agencies are ongoing and the company continues preparations for BLA and MAA submissions. -
Omeros announced inApril 2018 that theFDA granted breakthrough therapy designation to OMS721 for the treatment of patients with “high-risk” HSCT-TMA, specifically those patients who have persistent TMA despite modification of immunosuppressive therapy. This is the second breakthrough therapy designation for OMS721, which last year received the designation fromFDA for the treatment of IgA nephropathy. -
In
April 2018 ,Omeros reported new results in patients with HSCT-TMA from the ongoing OMS721 Phase 2 study. The analysis of 100-day mortality, an important endpoint previously used as an approval endpoint in another condition related to HSCT, showed that OMS721-treated patients had improved survival relative to the historical control (53% vs 10%; p = 0.0002). - Dosing in the U.S. cohort has been completed in the placebo-controlled portion of the company’s Phase 2 trial of OMS721 in IgA nephropathy. Data are expected in September.
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In
July 2018 , the European Medicines Agency’s (EMA’s) Committee for Orphan Medicinal Products (COMP) issued a positive opinion recommending orphan drug designation of OMS721 for treatment in hematopoietic stem cell transplantation. The positive opinion is expected to be adopted by theEuropean Commission in August.
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The company recently held successful meetings with the
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Developments regarding OMIDRIA include:
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In the recently released 2019 proposed rule for the Centers for
Medicare & Medicaid Services’ (CMS’) outpatient prospective payment system (OPPS), CMS indicated that it will separately pay in the ASC setting for non-opioid drugs with anFDA -approved indication for postoperative pain relief. Although not specifically named,Omeros believes that OMIDRIA meets this definition. -
Commercial activities have been focused on re-engaging and
expanding ASC and hospital customers in anticipation of the
recommencement of Medicare Part B separate payment beginning
October 1, 2018 throughSeptember 30, 2020 . -
In
May 2018 , the company entered into a settlement agreement and consent judgment withLupin Ltd. andLupin Pharmaceuticals, Inc. (collectively, Lupin) concerning Lupin’s filing of an ANDA seeking approval from theFDA to market a generic version of OMIDRIA. A similar settlement was reached with Par Pharmaceutical late last year. InJuly 2018 , the company announced that its patent infringement lawsuit againstSandoz Inc. (Sandoz ) had been dismissed by stipulation of the parties. All of Omeros’ litigation with ANDA filers has now been favorably concluded. The earliest ANDA entry date for any of the three generic manufacturers isApril 2032 unless otherwise subsequently authorized pursuant to the settlement agreements. -
In
July 2018 ,Omeros reported that OMIDRIA had been made available in theEuropean Union (EU) on a limited basis, which maintained the ongoing validity of the European marketing authorization for OMIDRIA. -
OMIDRIA was added to the
Veterans Health Administration (VA) National Formulary inApril 2018 . -
In
April 2018 ,Omeros announced that the results of four “real-world” clinical studies were presented at theAmerican Society of Cataract and Refractive Surgery andAmerican Society of Ophthalmic Administrators Annual Meeting. The studies demonstrate significant benefits of OMIDRIA to both patients and surgeons across routine and complex cataract surgery cases performed in high-volume surgery centers, with and without femtosecond laser.
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In the recently released 2019 proposed rule for the Centers for
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In Omeros’ PDE7 program, the company is developing proprietary
compounds to treat addiction and compulsive disorders as well as
movement disorders. In
June 2018 ,Omeros reported that it had obtained regulatory authority and ethics committee clearance to start the Phase 1 clinical trial evaluating the safety, tolerability, pharmacodynamics and pharmacokinetics of its lead PDE7 inhibitor, OMS527, in healthy subjects. Dosing has been completed in the first two cohorts of this Phase 1 clinical trial and to date, the drug remains well-tolerated. Data are expected in the first half of 2019. The initial target planned for OMS527 is nicotine addiction. -
As reported previously, the company’s credit facility with CRG was
amended in
April 2018 to eliminate the revenue and market capitalization covenants with respect to the 12-month period ending onDecember 31, 2018 and to reduce the market capitalization threshold for future periods to three times the aggregate principal amount of loans outstanding (i.e.,$375.0 million based onJune 30, 2018 borrowings) on the applicable determination date. InMay 2018 , the company borrowed the remaining$45.0 million available under this facility.
Financial Results
For the quarter ended
Total costs and expenses for the three months ended
For the three months ended
As of
Conference Call Details
Omeros’ management will host a conference call to discuss the financial
results and to provide an update on business activities. The call will
be held today at
To access the live or subsequently archived webcast of the conference call on the internet, go to the company’s website at www.omeros.com and select “Events” under the Investors section of the website. To access the live webcast, please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.
About
Forward-Looking Statements
This press release contains forward-looking statements within the
meaning of Section 27A of the Securities Act of 1933 and Section 21E of
the Securities Exchange Act of 1934, which are subject to the “safe
harbor” created by those sections for such statements. All statements
other than statements of historical fact are forward-looking statements,
which are often indicated by terms such as “anticipate,” “believe,”
“could,” “estimate,” “expect,” “goal,” “intend,” “likely,” “look forward
to,” “may,” “plan,” “potential,” “predict,” “project,” “prospects,”
“should,” “slated,” “will,” “would” and similar expressions and
variations thereof. Forward-looking statements are based on management’s
beliefs and assumptions and on information available to management only
as of the date of this press release. Omeros’ actual results could
differ materially from those anticipated in these forward-looking
statements for many reasons, including, without limitation, risks
associated with product commercialization and commercial operations,
unproven preclinical and clinical development activities, regulatory
oversight, intellectual property claims, competitive developments,
litigation, and the risks, uncertainties and other factors described
under the heading “Risk Factors” in the company’s Quarterly Report on
Form 10-Q filed with the
OMEROS CORPORATION | ||||||||||||||||||||
UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS | ||||||||||||||||||||
(In thousands, except share and per share data) | ||||||||||||||||||||
Three Months Ended | Six Months Ended | |||||||||||||||||||
June 30, | June 30, | |||||||||||||||||||
2018 | 2017 | 2018 | 2017 | |||||||||||||||||
Revenue: | ||||||||||||||||||||
Product sales, net | $ | 1,655 | $ | 17,151 | $ | 3,244 | $ | 29,408 | ||||||||||||
Costs and expenses: | ||||||||||||||||||||
Cost of product sales | 116 | 157 | 319 | 429 | ||||||||||||||||
Research and development | 19,412 | 13,137 | 37,551 | 25,377 | ||||||||||||||||
Selling, general and administrative | 12,744 | 15,796 | 23,678 | 28,267 | ||||||||||||||||
Total costs and expenses | 32,272 | 29,090 | 61,548 | 54,073 | ||||||||||||||||
Loss from operations | (30,617 | ) | (11,939 | ) | (58,304 | ) | (24,665 | ) | ||||||||||||
Interest expense | (3,676 | ) | (2,723 | ) | (6,502 | ) | (5,386 | ) | ||||||||||||
Other income | 597 | 303 | 1,056 | 603 | ||||||||||||||||
Net loss | $ | (33,696 | ) | $ | (14,359 | ) | $ | (63,750 | ) | $ | (29,448 | ) | ||||||||
Comprehensive loss | $ | (33,696 | ) | $ | (14,359 | ) | $ | (63,750 | ) | $ | (29,448 | ) | ||||||||
Basic and diluted net loss per share | $ | (0.70 | ) | $ | (0.33 | ) | $ | (1.32 | ) | $ | (0.67 | ) | ||||||||
Weighted-average shares used to compute basic and diluted net loss per share |
48,384,460 | 44,037,471 | 48,333,610 | 43,933,022 | ||||||||||||||||
OMEROS CORPORATION | ||||||||||
UNAUDITED CONSOLIDATED BALANCE SHEET DATA | ||||||||||
(In thousands) | ||||||||||
June 30, |
December 31, |
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Cash, cash equivalents and short-term investments | $ | 88,404 | $ | 83,749 | ||||||
Working capital | 72,062 | 82,065 | ||||||||
Restricted investments | 5,779 | 5,835 | ||||||||
Total assets | 106,349 | 116,328 | ||||||||
Total current liabilities | 24,442 | 26,307 | ||||||||
Notes payable and lease financing obligations, net | 130,358 | 84,607 | ||||||||
Accumulated deficit | (587,118 | ) | (523,368 | ) | ||||||
Total shareholders’ deficit | (56,297 | ) | (2,814 | ) | ||||||
View source version on businesswire.com: https://www.businesswire.com/news/home/20180809005728/en/
Source:
Cook Williams Communications, Inc.
Jennifer Cook Williams,
360-668-3701
Investor and Media Relations
[email protected]