Omeros Corporation Reports Second Quarter 2018 Financial Results
– Conference Call Today at
2Q 2018 total and OMIDRIA® revenues were
$1.7 million, compared to $17.2 millionin 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, 2018through September 30, 2018) in which transitional pass-through reimbursement for OMIDRIA is unavailable. Pass-through status for OMIDRIA will reinitiate on October 1, 2018and is scheduled to remain in effect through September 30, 2020.
Net loss in 2Q 2018 was
$33.7 million, or $0.70per share. Non-cash expenses for 2Q 2018 were $4.6 million, or $0.10per share.
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
May 2018, and patent infringement lawsuit against Sandozwas dismissed in July 2018because Sandozstipulated to no longer pursue its Abbreviated New Drug Application (ANDA) prior to OMIDRIA patent expiration in 2033, resolving all litigation with ANDA filers.
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
Second Quarter and Recent Developments
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:
The company recently held successful meetings with the
FDAand 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.
Omerosannounced in April 2018that the FDAgranted 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 from FDAfor the treatment of IgA nephropathy.
April 2018, Omerosreported 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.
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 the European Commissionin August.
- The company recently held successful meetings with the
Developments regarding OMIDRIA include:
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 an FDA-approved indication for postoperative pain relief. Although not specifically named, Omerosbelieves 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, 2018through September 30, 2020.
May 2018, the company entered into a settlement agreement and consent judgment with Lupin Ltd.and Lupin Pharmaceuticals, Inc.(collectively, Lupin) concerning Lupin’s filing of an ANDA seeking approval from the FDAto market a generic version of OMIDRIA. A similar settlement was reached with Par Pharmaceutical late last year. In July 2018, the company announced that its patent infringement lawsuit against Sandoz 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 is April 2032unless otherwise subsequently authorized pursuant to the settlement agreements.
July 2018, Omerosreported that OMIDRIA had been made available in the European 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 in April 2018.
April 2018, Omerosannounced that the results of four “real-world” clinical studies were presented at the American Society of Cataract and Refractive Surgeryand American Society of Ophthalmic AdministratorsAnnual 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.
- In the recently released 2019 proposed rule for the Centers for
In Omeros’ PDE7 program, the company is developing proprietary
compounds to treat addiction and compulsive disorders as well as
movement disorders. In
June 2018, Omerosreported 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
April 2018to eliminate the revenue and market capitalization covenants with respect to the 12-month period ending on December 31, 2018and to reduce the market capitalization threshold for future periods to three times the aggregate principal amount of loans outstanding (i.e., $375.0 millionbased on June 30, 2018borrowings) on the applicable determination date. In May 2018, the company borrowed the remaining $45.0 millionavailable under this facility.
For the quarter ended
Total costs and expenses for the three months ended
For the three months ended
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.
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
|UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except share and per share data)|
|Three Months Ended||Six Months Ended|
|June 30,||June 30,|
|Product sales, net||$||1,655||$||17,151||$||3,244||$||29,408|
|Costs and expenses:|
|Cost of product sales||116||157||319||429|
|Research and development||19,412||13,137||37,551||25,377|
|Selling, general and administrative||12,744||15,796||23,678||28,267|
|Total costs and expenses||32,272||29,090||61,548||54,073|
|Loss from operations||(30,617||)||(11,939||)||(58,304||)||(24,665||)|
|Basic and diluted net loss per share||$||(0.70||)||$||(0.33||)||$||(1.32||)||$||(0.67||)|
Weighted-average shares used to compute basic and diluted net loss per share
|UNAUDITED CONSOLIDATED BALANCE SHEET DATA|
|Cash, cash equivalents and short-term investments||$||88,404||$||83,749|
|Total current liabilities||24,442||26,307|
|Notes payable and lease financing obligations, net||130,358||84,607|
|Total shareholders’ deficit||(56,297||)||(2,814||)|
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Cook Williams Communications, Inc.
Jennifer Cook Williams, 360-668-3701
Investor and Media Relations