Omeros Corporation Reports Second Quarter 2016 Financial Results
-- Conference Call Today at
2Q 2016 total and OMIDRIA® revenues were
$10.0 million. Revenues from OMIDRIA sales rose 220% from the prior year quarter and 38% from 1Q 2016.
Net loss in 2Q 2016 was
$12.6 million, or $0.32per share, which included $3.2 million( $0.08per share) of non-cash expenses. Net loss in the prior year quarter was $16.7 millionor $0.44per share, which included $2.7 million( $0.07per share) of non-cash expenses.
Completed enrollment in a
U.S. Food and Drug Administration( FDA) required post-marketing OMIDRIA pediatric clinical study; the product is eligible for an additional six months of U.S. marketing exclusivity upon successful completion of the study.
Completed successful meeting with
European Medicines Agency(EMA) regarding requirements for OMS721 Phase 3 program for the treatment of atypical hemolytic uremic syndrome (aHUS); the same single-arm Phase 3 clinical trial will support the submission package for marketing approvals in the U.S. and Europe.
- Initiated dosing in a Phase 2 clinical trial evaluating OMS721 in patients with complement-related renal disorders.
“OMIDRIA generated solid sales growth in the second quarter,” said
Second Quarter and Recent Highlights and Developments
Highlights and developments regarding OMIDRIA include:
June 2016, Omerosannounced the completion of enrollment in an FDArequired post-marketing OMIDRIA pediatric clinical trial which, if completed in compliance with FDAclinical trial regulations and pre-specified timelines, results in eligibility for an additional six months of marketing exclusivity for OMIDRIA. The trial is being conducted in compliance with FDAregulations and within the specified timelines. OMIDRIA is not yet approved for use in patients less than 18 years of age, and the trial is expected to provide clinical information on the use of OMIDRIA in the pediatric population.
As previously announced,
Omerosand ITROM Trading Drug Store(ITROM) entered into an exclusive supply and distribution agreement for the sale of OMIDRIA in the Kingdom of Saudi Arabia, the United Arab Emiratesand certain other countries in the Middle East. Under the agreement, ITROM will be responsible for obtaining marketing authorizations for OMIDRIA within the licensed territories in addition to marketing and distributing OMIDRIA supplied by Omeros. Omerosexpects ITROM to begin selling OMIDRIA later this year on a limited basis assuming submission of appropriate regulatory applications.
Highlights and developments regarding OMS721, Omeros’ lead human
monoclonal antibody in its mannan-binding lectin-associated serine
protease-2 (MASP-2) program for the treatment of thrombotic
microangiopathies (TMAs), including aHUS and hematopoietic stem cell
transplant-related (HSCT) TMAs, and for the treatment of
complement-related renal diseases, include:
In the company’s Phase 2 clinical program evaluating OMS721 in
patients with complement-related renal disorders,
Omerosinitiated dosing in a Phase 2 clinical trial that includes patients with IgA nephropathy, membranous nephropathy, C3 glomerulopathy and lupus nephritis.
Omerosreceived scientific advice from the EMA directed to its OMS721 Phase 3 program for the treatment of aHUS. The advice received is generally consistent with that from the FDAearlier this year and will allow Omerosto submit applications for approval in the U.S. and in the European Union(EU) based on a single data set, which includes the results from one pivotal clinical trial – a single-arm (i.e., no control arm), open-label study in patients with newly diagnosed or ongoing aHUS. Based on this EMA advice, the company plans to run the same, single Phase 3 clinical program to support OMS721 marketing approval applications in both the U.S. and in the EU for the treatment of aHUS.
- In the company’s Phase 2 clinical program evaluating OMS721 in patients with complement-related renal disorders,
August 2016, the company announced results from its OMS906 complement program showing that OMS906 reduced both the incidence and severity of disease in a well-established animal model of arthritis mediated by the alternative pathway of complement (APC). OMS906 is Omeros’ lead antibody targeting mannan-binding lectin-associated serine protease-3 (MASP-3), a protein essential for the activation of the APC. Omerosexclusively controls the use of MASP-3 inhibitors for the treatment of APC-related diseases and disorders. The company is initiating the process of manufacturing scale-up of OMS906 in preparation for clinical trials.
May 2016, Omerosamended its existing credit facility with Oxford Finance LLCand East West Bankto provide the company with an additional $20 millionin unrestricted cash by funding the remaining tranches of the facility. Omerosissued warrants to the lenders, exercisable for seven years for up to 100,602 shares of the company’s common stock at an exercise price per share of $9.94, which was the closing price of the company’s stock on the funding date. The final payment fee rate on the $20 millionborrowed increased from 5.25% to 6.25%, reflecting the accelerated draw-down of these additional funds. All loan payments are interest-only until August 1, 2017.
For the quarter ended
Total costs and expenses for the three months ended
For the three months ended
For the six months ended
Total costs and expenses for the six months ended
For the six 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 event will
be held today at
To access the live or subsequently archived webcast of the conference call, go to the company’s website at www.omeros.com and go to “Events” under the Investors section of the website. To access the live call, please connect to the website at least 15 minutes prior to the call to allow for any software download that may be necessary.
Omeros is a biopharmaceutical company committed to discovering,
developing and commercializing both small-molecule and protein
therapeutics for large-market as well as orphan indications targeting
inflammation, coagulopathies and disorders of the central nervous
system. Part of its proprietary PharmacoSurgery® platform,
the company’s first drug product, OMIDRIA® (phenylephrine and
ketorolac injection) 1%/0.3%, was broadly launched in the U.S. in
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,” “look forward to,”
“may,” “plan,” “potential,” “predict,” “project,” “should,” “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 including with respect to OMIDRIA®, Omeros’
ability to partner and commercialize OMIDRIA in the
|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||$||10,004||$||3,125||$||17,250||$||3,363|
|Costs and expenses:|
|Cost of product sales||327||365||654||376|
|Research and development||10,231||10,900||25,665||20,218|
|Selling, general and administrative||10,375||7,889||21,485||16,878|
|Total costs and expenses||20,933||19,154||47,804||37,472|
|Loss from operations||(10,929||)||(15,967||)||(30,381||)||(33,897||)|
|Other income (expense), net||174||224||462||442|
|Basic and diluted net loss per share||$||(0.32||)||$||(0.44||)||$||(0.86||)||$||(0.95||)|
Weighted-average shares used to compute basic and
diluted net loss per share
|CONSOLIDATED BALANCE SHEET DATA|
|June 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||21,237||$||28,263|
|Total current liabilities||16,065||16,253|
|Notes payable, net||69,833||49,769|
|Total shareholders’ deficit||(48,995||)||(26,234||)|
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Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor and Media Relations