Omeros Corporation Reports First Quarter 2016 Financial Results
-- Conference Call Today at
1Q 2016 revenues were
$7.4 million, an 11% increase over 4Q 2015.
Net loss in 1Q was
$20.5 million, or $0.54per share, which included $4.7 million( $0.12per share) of non-cash expenses.
- OMIDRIA units shipped by wholesalers (“sell-through”) increased 20% over 4Q 2015.
- OMIDRIA sales accelerated substantially in the second half of 1Q, with March accounting for nearly 50% of quarterly sales.
- OMIDRIA sales growth trajectory has continued into 2Q with sales to date approximately 65% higher than the corresponding period in 1Q.
Based on recent sales activity, net sales of OMIDRIA, without any
additional growth, annualize to an approximate run rate of
$45 millionto $50 million.
Entered into sales agreement for OMIDRIA in the
Middle Eastin May 2016.
- Initiated Phase 3 program of OMS721 for treatment of atypical hemolytic uremic syndrome (aHUS), with patient enrollment expected later this year, and commenced patient dosing in OMS721 Phase 2 program in complement-related, corticosteroid-dependent renal diseases.
“OMIDRIA sales continued to grow substantially in Q1,” said Gregory A.
Demopulos, M.D., chairman and chief executive officer of
First Quarter and Recent Highlights and Developments
Highlights and developments regarding OMS721, the company’s lead human
monoclonal antibody in its mannan-binding lectin-associated serine
protease-2 (MASP-2) program for the treatment of thrombotic
microangiopathies (TMAs), including atypical hemolytic uremic syndrome
Omerosinitiated a Phase 3 OMS721 program that will consist of one clinical trial – a single-arm (i.e., no control arm), open-label trial in patients with newly diagnosed or ongoing aHUS. Phase 3 enrollment is expected to begin later this year and patients currently being treated in the Phase 2 trial are likely to be included in the Phase 3 program. Omerosalso plans to pursue accelerated approval for OMS721 in aHUS.
In the company’s Phase 2 clinical program evaluating OMS721 in
patients with complement-related renal disorders,
Omerosinitiated dosing in a new Phase 2 clinical trial that includes patients with corticosteroid-dependent IgA nephropathy, membranous nephropathy, C3 glomerulopathy and lupus nephritis.
Finland, based on review of OMS721 data, requested access to OMS721 under a Special License, granted by the Finnish regulatory authorities, for compassionate use in a patient with aHUS. The patient was previously treated with Soliris® (eculizumab) but did not have an adequate response according to the requesting physicians and was continuing to display signs of active aHUS.
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. Based in Dubaiand internationally recognized, ITROM markets, sells and distributes ophthalmic pharmaceutical products in the Middle East. Under the agreement, ITROM will be responsible for obtaining marketing authorizations for OMIDRIA within the licensed territory in addition to marketing and distributing OMIDRIA supplied by Omeros. Omerosexpects ITROM to begin selling OMIDRIA later this year.
March 2016, Omeroswas granted by the U.S. Patent and Trademark Office a fourth OMIDRIA patent directed to methods of use. Omerosamended its patent infringement lawsuit against Par Pharmaceutical to assert this additional patent.
A U.S. Patent was granted to
Omerosthat is directed to the use of any phosphodiesterase-7, or PDE7, inhibitor to treat any substance addiction or any addictive or compulsive behavior. Omerosexpects to advance its OMS527 PDE7 inhibitor program into the clinic in 2017.
As previously reported,
Omerosconverted 26 of its previously contracted OMIDRIA field sales representatives to Omerosemployees effective January 1, 2016. In connection with the conversion, the company also hired 11 additional sales representatives during the first quarter. In January 2016, Omerosalso entered into a commission-only contract sales agent agreement with Precision Lens to cover “square” states in the Midwest that were not previously covered by the company’s sales force. Both the additional representatives and Precision Lens began making sales calls in February.
For the quarter ended
Sales were restrained in the first half of 1Q, likely due to a number of factors including: low cataract surgery procedural volumes in the first quarter of each year; a series of large ophthalmology annual meetings attracting high-volume cataract surgeons; and Omeros’ conversion of two-thirds of its contract to an in-house sales force and filling out the remaining one-third of the sales force with additional direct hires who began making sales calls in February. Also in February, our commission-only sales agents from Precision Lens, covering states in the Midwest, began making sales calls.
OMIDRIA sales accelerated substantially in the second half of 1Q, with
March accounting for nearly 50% of quarterly sales. OMIDRIA sales growth
trajectory has continued into 2Q with sales to date approximately 65%
higher than the corresponding portion of 1Q. Based on recent sales
activity, net sales of OMIDRIA, without any additional growth, annualize
to an approximate run rate of
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 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. Derived from 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,” “likely,” “look forward
to,” “may,” “plan,” “potential,” “predict,” “project,” “shaping up,”
“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|
|Product sales, net||$||7,246||$||238|
|Costs and expenses:|
|Cost of product sales||327||11|
|Research and development||15,434||9,318|
|Selling, general and administrative||11,110||8,989|
|Total costs and expenses||26,871||18,318|
|Loss from operations||(19,452||)||(17,930||)|
|Other income (expense), net||288||218|
|Basic and diluted net loss per share||$||(0.54||)||$||(0.51||)|
Weighted-average shares used to compute Basic and diluted net loss per share
|CONSOLIDATED BALANCE SHEET DATA|
|March 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||13,244||$||28,263|
|Working capital (deficit)||6,801||20,893|
|Restricted cash and investments||10,679||10,679|
|Total current liabilities||17,521||16,253|
|Total shareholders’ deficit||(40,742||)||(26,234||)|
Cook Williams Communications, Inc.
Jennifer Cook Williams
Investor and Media Relations