Omeros Corporation Reports Fourth Quarter and Year-End 2015 Financial Results
Conference Call Tomorrow,
For 4Q 2015, sales revenues of OMIDRIA® (phenylephrine and
ketorolac injection) 1% / 0.3% were
$6.7 million, a 105% increase over 3Q, with OMIDRIA units shipped by wholesalers (“sell-through”) increasing 74% over 3Q.
2015 revenues were
$13.5 million, $13.3 millionof which were from OMIDRIA sales following broad U.S. launch in April 2015.
Net loss in 4Q 2015 was
$19.8 million, or $0.52per share, and, for the full year of 2015, was $75.1 million, or $2.00per share. Both periods include a $1.3 million( $0.03per share in 4Q) charge for early extinguishment of previously existing debt. In addition, non-cash expenses for 4Q and the full year of 2015 were $2.8 million, or $0.07per share, and $11.0 million, or $0.29per share, respectively.
- Expanded Phase 2 OMS721 clinical trials to include immunoglobulin A (IgA) nephropathy and other complement-related renal disorders.
- Launched OMIDRIAssure™ Reimbursement Services Program to expand patient access to OMIDRIA.
Closed secured credit facility in
December 2015, receiving $22.3 millionin net proceeds with an additional $20.0 millionavailable dependent on achieving certain OMIDRIA revenues.
“We are pleased with the quarter-over-quarter growth in OMIDRIA sales
and look forward to accelerating sales in 2016 now that we have a full
cadre of ‘in-house’ sales representatives, broader regional access
across the U.S. and increasing utilization of our OMIDRIAssure program
by surgeons and facilities nationwide,” said
Fourth 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
Based on the positive efficacy and safety data in TMAs as well as
the known biology of complement-related renal disorders,
Omerosis currently expanding clinical trials to evaluate OMS721 in IgA nephropathy and other complement-related renal disorders.
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.
- Based on the positive efficacy and safety data in TMAs as well as the known biology of complement-related renal disorders,
To help ensure that patients, surgeons and facilities can access the
benefits of OMIDRIA,
Omerosintroduced the OMIDRIAssure™ Reimbursement Services Program in 4Q 2015 with comprehensive reimbursement services including two patient assistance programs to cover the cost of OMIDRIA: (1) the “Equal Access” Patient Assistance Program for financially eligible government-insured and uninsured patients and (2) the “We Pay the Difference” Commercial Reimbursement Program for patients with insufficient commercial insurance.
An additional U.S. Patent directed to methods of using OMIDRIA was
Omerosand will issue on March 8, 2016. This additional patent was granted by the U.S. Patent and Trademark Office after the Patent Office considered all prior art that was identified by Par Sterile Products, LLCand Par Pharmaceutical, Inc., or Par, in its Paragraph IV Notice Letter concerning its Abbreviated New Drug Application requesting FDAapproval for a generic version of OMIDRIA, which could be approved no earlier than the end of January 2018while the company’s lawsuit against Par is pending. Omeroswill seek leave to amend its complaint for patent infringement against Par to enforce this patent in addition to the three other OMIDRIA patents already included in Omeros’ complaint.
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.
The company closed a
$70.0 millionsecured credit facility with OxfordFinance and East West Bank(Credit Facility), receiving $22.3 millionin net proceeds at closing. Omeroshas the ability, subject to the satisfaction of certain conditions including the achievement of net revenue milestones for OMIDRIA, to access the final $20.0 millionof the credit facility in two tranches until June 30, 2017.
Omeroshired 26 of its previously contracted OMIDRIA field sales representatives effective January 1, 2016. The remaining territories were filled by hiring additional seasoned representatives, many with focused ophthalmology experience. Omeroscurrently employs 37 dedicated sales representatives. In January 2016, Omerosalso entered into a commission-only contract sales agent agreement with Precision Lens to cover territories in the Midwest that are not covered by the company’s in-house sales force.
Fourth Quarter 2015
For the quarter ended
Total costs and expenses for the three months ended
For the three months ended
Full Year 2015
Revenue for the full year 2015 was
Total costs and expenses for the year ended
For the full year 2015,
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 tomorrow,
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,” “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
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except share and per share data)|
|Three Months Ended||Twelve Months Ended|
|December 31,||December 31,|
|Product sales, net||$||6,657||$||—||$||13,264||$||—|
|Costs and expenses:|
|Cost of product sales||417||—||1,041||—|
|Research and development||14,897||11,750||48,379||47,946|
|Selling, general and administrative||9,401||8,405||35,327||22,601|
|Total costs and expenses||24,715||20,155||84,747||70,547|
|Loss from operations||(18,040||)||(19,975||)||(71,238||)||(70,008||)|
|Loss on early extinguishment of debt||(1,315||)||—||(1,315||)||—|
|Other income (expense), net||337||177||1,030||(195||)|
|Basic and diluted net loss per share||$||(0.52||)||$||(0.61||)||$||(2.00||)||$||(2.22||)|
Weighted-average shares used to compute Basic and diluted net loss per share
|CONSOLIDATED BALANCE SHEET DATA|
|December 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||28,263||$||6,886|
|Working capital (deficit)||20,893||(9,274||)|
|Restricted cash and investments||10,679||679|
|Total current liabilities||16,253||18,315|
|Total shareholders’ deficit||(26,234||)||(42,654||)|
Cook Williams Communications, Inc.
Investor and Media Relations
Jennifer Cook Williams, 360-668-3701