Omeros Corporation Reports Fourth Quarter and Year-End 2016 Financial Results
-- Conference Call Today at
4Q 2016 total and OMIDRIA® revenues were
$12.9 million. Revenues from OMIDRIA sales rose 94% from the prior year’s fourth quarter and 14% from 3Q 2016. OMIDRIA units sold in the fourth quarter increased by 22% over the third quarter.
Total year 2016 revenues were
$41.6 million, a 208% increase over 2015, the year in which OMIDRIA was launched.
Net loss in 4Q 2016 was
$19.6 million, or $0.45per share, and, for the full year of 2016, was $66.7 million, or $1.65per share. Both periods included a $5.6 million( $0.13per share in 4Q) charge for early extinguishment of previously existing debt. Non-cash expenses for 4Q and the full year of 2016 were $5.2 million, or $0.12per share, and $16.1 million, or $0.40per share, respectively.
- Successful outcome of post-marketing clinical trial of OMIDRIA in pediatric patients undergoing cataract surgery, which is expected to result in an additional six months of regulatory exclusivity.
- Opened enrollment in Phase 3 clinical trial of OMS721 in patients with atypical hemolytic uremic syndrome (aHUS).
- Positive data from Phase 2 clinical trials of OMS721 in both renal disorders and hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
“2016 was a year of significant achievements across a wide range of our
Fourth Quarter and Recent Highlights and Developments
Omerosreported in November 2016the successful outcome of its recently completed post-marketing clinical trial of the effect of OMIDRIA in pediatric patients undergoing cataract surgery. In the trial, OMIDRIA was well tolerated with adverse event rates consistent with those seen in pediatric cataract surgery and with the control group. The company plans to submit a supplemental NDA this year, requesting expanded label language to cover patients of any age. Omerosexpects that this submission will result in an additional six months of regulatory exclusivity for OMIDRIA.
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 HSCT-TMA, and for the
treatment of complement-related renal diseases, include:
- Enrollment has opened in Omeros’ Phase 3 clinical trial in patients with aHUS.
Omerosreported positive data (p = 0.017) from its Phase 2 clinical trial of OMS721 for the treatment of renal disorders, including IgA nephropathy and membranous nephropathy, in October 2016. In this trial, OMS721 significantly improved key endpoints of renal function, and patients achieved partial remission with only 12 weeks of dosing. Also in October 2016, Omerosannounced positive results in patients with HSCT-TMA from the company’s Phase 2 clinical trial of OMS721 in TMAs, with clinically meaningful improvement in measures of red blood cell destruction, specifically lactate dehydrogenase (LDH) and haptoglobin levels (p < 0.01 and p < 0.06, respectively).
Following discussion with the
FDA, the company plans to pursue breakthrough therapy designation for OMS721 in IgA nephropathy and in HSCT-TMA. Omerosalso has been pursuing accelerated approval for OMS721 in both of these indications as well as in aHUS. The FDAhas granted fast track designation for OMS721 in patients with aHUS and orphan designation for OMS721 in patients with TMAs, including aHUS and HSCT-TMA.
Highlights and developments regarding OMS906, Omeros’ lead antibody
targeting mannan-binding lectin-associated serine protease-3 (MASP-3),
a protein essential for the activation of the alternative pathway of
complement (APC), include:
November 2016, the company announced data from the evaluation of OMS906 in non-human primates. Single-dose administration of OMS906 to cynomolgus monkeys resulted in sustained ablation of systemic APC activity for approximately 16 days. The APC is involved in a wide range of diseases, including paroxysmal nocturnal hemoglobinuria (PNH), aHUS, age-related macular degeneration, arthritis, asthma and traumatic brain injury. No safety concerns were identified.
Omerosis finalizing selection of lead and back-up molecules and preparing to initiate scale-up for clinical trials. The company is evaluating PNH as the first clinical indication for OMS906.
October 2016, Omerosentered into a $125.0 millionsenior secured credit facility with CRG Servicing LLC, under which the company borrowed $80.0 millionin November 2016. The credit facility has a six-year term with four years (through December 31, 2020) of interest-only payments after which quarterly principal and interest payments will be due through the September 30, 2022maturity date; in addition, there is the potential to extend the interest-only period through maturity if certain milestones are satisfied. The company may borrow additional tranches of up to $25.0 millionand $20.0 million, subject to the satisfaction of certain milestones on or before June 30, 2017and December 31, 2017, respectively.
Fourth Quarter 2016
For the quarter ended
Total operating costs and expenses for the three months ended
For the three months ended
Full Year 2016
Revenues for the full year 2016 were
Total operating costs and expenses for the year ended
For the full year 2016,
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.
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 and commercial operations, financial reimbursement
coverage from governmental and third-party payers for products and
related treatments, 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 Annual Report on Form 10-K filed with the
|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||$||12,905||$||6,657||$||41,444||$||13,264|
|Costs and expenses:|
|Cost of product sales||380||417||1,412||1,041|
|Research and development||12,542||14,897||50,699||48,379|
|Selling, general and administrative||11,840||9,401||43,782||35,327|
|Total costs and expenses||24,762||24,715||95,893||84,747|
|Loss from operations||(11,857||)||(18,040||)||(54,276||)||(71,238||)|
|Loss on early extinguishment of debt||(5,595||)||(1,315||)||(5,595||)||(1,315||)|
|Other income (expense), net||272||337||945||1,030|
|Basic and diluted net loss per share||$||0.45||$||0.52||$||1.65||$||2.00|
Weighted-average shares used to compute basic and diluted net loss per share
|CONSOLIDATED BALANCE SHEET DATA|
|December 31,||December 31,|
|Cash, cash equivalents and short-term investments||$||45,331||$||28,263|
|Restricted cash and investments||5,835||10,679|
|Total current liabilities||16,071||16,253|
|Notes payable and leasing obligations, net||79,710||49,842|
|Total shareholders’ deficit||(37,447||)||(26,234||)|
Cook Williams Communications, Inc.
Jennifer Cook Williams, 360-668-3701
Investor and Media Relations