Omeros Corporation Reports Third Quarter 2016 Financial Results
-- Conference Call Today at
3Q 2016 total and OMIDRIA® revenues were
$11.3 million. Revenues from OMIDRIA sales rose 248% from the prior year quarter and 13% from 2Q 2016. OMIDRIA units sold by wholesalers to customers (“sell-through”) increased by 18% over the second quarter.
Net loss in 3Q 2016 was
$14.0 million, or $0.34per share, which included $3.1 million( $0.08per share) of non-cash expenses. Net loss in the prior year quarter was $19.9 millionor $0.53per share, which included $2.7 million( $0.07per share) of non-cash expenses.
- Positive data from Phase 2 clinical trials of OMS721 in both kidney disorders and hematopoietic stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
Requested fast track designation and orphan drug designation from
U.S. Food and Drug Administration( FDA) for the development of OMS721 for the treatment of patients with immunoglobulin A (IgA) nephropathy. The company plans to pursue breakthrough therapy designation for OMS721 in IgA nephropathy and HSCT-TMA and accelerated approval for OMS721 in both of those indications as well as in atypical hemolytic uremic syndrome (aHUS).
- Positive data from two Phase 2 clinical trials evaluating a PPAR-gamma agonist in cocaine abuse disorder and in heroin addiction for its OMS405 program.
Closed equity financing in
August 2016, receiving $37.3 millionin net proceeds.
$125 millioncredit facility in November 2016to retire the company’s existing credit facility, which will reduce restricted cash requirements and provide additional working capital.
“Omeros’ achievements this quarter underscore the breadth and strength
of our commercial and development programs,” said
Third Quarter and Recent Highlights and Developments
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:
The company reported in
October 2016positive data (p = 0.017) from its Phase 2 clinical trial of OMS721 for the treatment of kidney disorders, including IgA nephropathy and membranous nephropathy, none of which currently have an approved treatment and all of which frequently lead to end-stage renal disease and dialysis. In this trial, OMS721 significantly improved key endpoints of renal function and patients achieved partial remission with 12 weeks of dosing.
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).
Omerosreported in October 2016that it has requested fast track designation and orphan drug designation from the FDAfor the development of OMS721 for the treatment of patients with IgA nephropathy. The company plans to pursue breakthrough therapy designation for OMS721 in IgA nephropathy and HSCT-TMA and accelerated approval for OMS721 in both of those indications as well as in aHUS. The FDAalready has granted fast track designation for OMS721 in patients with aHUS and orphan designation for OMS721 in patients with TMAs, including aHUS and HSCT-TMA.
Omerosreported in August 2016that it received scientific advice from the European Medicines Agency(EMA) directed to its OMS721 Phase 3 program for the treatment of aHUS. Based on this EMA advice, the company plans to run the same, single-arm Phase 3 clinical trial to support OMS721 marketing approval applications in both the U.S. and in the EU for the treatment of aHUS.
- The company reported in
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:
Announced results in
August 2016showing that OMS906, in a well-established animal model associated with paroxysmal nocturnal hemoglobinuria (PNH), improved the survival of red blood cells four-fold better than a complement component 5 (C5) inhibitor.
As previously reported, in
August 2016 Omerosannounced results showing that OMS906 reduced both the incidence and severity of disease in a well-established animal model of arthritis known to be mediated by the APC.
- The company is finalizing selection of lead and back-up molecules and is initiating the process for scale-up in its OMS906 program in preparation for clinical trials.
- Announced results in
For Omeros’ OMS405 peroxisome proliferator-activated receptor
(PPAR)-gamma agonist program, highlights and developments include:
October 2016, the company announced positive data (i.e., decreased craving and protection of brain white matter) from a Phase 2 clinical trial evaluating the effects of a PPAR-gamma agonist in patients with cocaine use disorders.
November 2016, Omerosannounced positive data (i.e., reduction in drug craving and in measures of anxiety) from a Phase 2 clinical trial evaluating the effects of a PPAR-gamma agonist in heroin addiction.
Omerosclosed a public common stock offering in August 2016in which the company received net proceeds of approximately $37.3 million.
October 2016, the company entered into a senior secured credit facility with CRG Servicing LLC. The company borrowed $80.0 millionin November 2016and 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. 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 secured credit facility bears interest at an annual fixed rate of 12.25%, (4.0% of which can be deferred at the company’s option during the interest-only period by adding such amount to the aggregate principal loan amount). The credit facility is secured by a lien on substantially all of the company’s assets. The initial borrowing provided approximately $8.0 millionof cash available for operations after taking into consideration the repayment of the prior credit facility and the reduced restricted cash requirement under the new secured credit facility.
- With funds on hand and current annualized OMIDRIA revenues and expenses, we anticipate that the company has at least 12 months of operating capital.
For the quarter ended
Total costs and expenses for the three months ended
For the three months ended
For the nine months ended
Total costs and expenses for the nine months ended
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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 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 Quarterly Report on Form 10-Q filed with the
|CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except share and per share data)|
|Three Months Ended||Nine Months Ended|
|September 30,||June 30,|
|Product sales, net||$||11,289||$||3,244||$||28,539||$||6,607|
|Costs and expenses:|
|Cost of product sales||378||248||1,032||624|
|Research and development||12,492||13,264||38,157||33,482|
|Selling, general and administrative||10,457||9,048||31,942||25,926|
|Total costs and expenses||23,327||22,560||71,131||60,032|
|Loss from operations||(12,038||)||(19,301||)||(42,419||)||(53,198||)|
|Other income (expense), net||211||251||673||693|
|Basic and diluted net loss per share||$||(0.34||)||$||(0.53||)||$||(1.19||)||$||(1.48||)|
Weighted-average shares used to compute basic and diluted net loss per share
|CONSOLIDATED BALANCE SHEET DATA|
|September 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||47,441||$||28,263|
|Total current liabilities||16,057||16,253|
|Notes payable, net of current portion||70,289||49,769|
|Total shareholders’ deficit||(22,772||)||(26,234||)|
Cook Williams Communications, Inc.
Jennifer Cook Williams, 360-668-3701
Investor and Media Relations