Omeros Corporation Reports Third Quarter 2017 Financial Results
Conference Call Today at
3Q 2017 total and OMIDRIA® revenues were
$21.7 million. Revenues from OMIDRIA sales rose 26 percent from 2Q 2017 and 92 percent from the prior year’s third quarter. Units sold to wholesalers, or “sell-in,” increased 26 percent quarter-over-quarter and 125 percent year-over-year.
Net loss in 3Q 2017 was
$7.5 million, or $0.16per share, which included $4.2 million( $0.09per share) of non-cash expenses. Net loss in the prior year’s third quarter was $14.0 millionor $0.34per share, which included $3.1 million( $0.08per share) of non-cash expenses.
September 30, 2017, the company had cash, cash equivalents and short-term investments available for operations of $86.8 millionplus the ability to borrow an additional $45.0 millionfrom existing lenders.
Settled patent infringement lawsuit against
Par Pharmaceutical, Inc.and its affiliate (collectively, Par) on favorable terms in October 2017.
FDAin follow-up to FDA’s granting breakthrough designation for OMS721 in immunoglobin A (IgA) nephropathy; the Agency’s meeting minutes state that approval can be obtained with a single successful Phase 3 trial with reduction in proteinuria as the primary efficacy endpoint.
FDAgranted OMS721 orphan drug designation in IgA nephropathy.
“OMIDRIA revenues sustained their strong growth in the third quarter and
this momentum continues into the current quarter,” said Gregory A.
Demopulos, M.D., chairman and chief executive officer of
Third Quarter and Recent Highlights and Developments
In October, the company entered into a settlement agreement and
consent judgment with Par, which resolved Omeros’ patent litigation
against Par. The litigation concerned Par’s filing of an Abbreviated
New Drug Application (ANDA) seeking approval from the
FDAto market a generic version of OMIDRIA. Pursuant to the settlement agreement and consent judgment, Par is prohibited from launching a generic version of OMIDRIA until April 1, 2032or as detailed in the settlement agreement. Par also acknowledged and confirmed the validity of Omeros’ OMIDRIA patents at issue in the lawsuit in the settlement agreement.
Highlights and developments regarding OMS721, Omeros’ lead human
monoclonal antibody in its mannan-binding lectin-associated serine
protease-2 (MASP-2) programs for the treatment of thrombotic
microangiopathies (TMAs), including atypical hemolytic uremic syndrome
(aHUS) and hematopoietic stem cell-associated TMA (HSCT-TMA), and for
the treatment of complement-related renal diseases, including IgA
Omerosmet with the FDAin follow-up to the FDA’s granting breakthrough designation for OMS721 in IgA nephropathy to discuss Phase 3 trial design. The Agency’s meeting minutes make clear that approval can be obtained with a single successful Phase 3 trial with reduction in proteinuria as the primary efficacy endpoint. Depending on the size of the effect on proteinuria, either full approval or accelerated approval is possible. If full approval is granted based on reduction in proteinuria, estimated glomerular filtration rate (eGFR) will be followed as part of the safety assessment. Any effect of OMS721 on eGFR is likely to result in additional label claims for the product. If, based on the effect on proteinuria, accelerated rather than full approval is granted, marketing of OMS721 would be allowed during which time confirmatory data on long-term effects of OMS721 on eGFR would be collected. These eGFR data, if satisfactory, would then form the basis for full approval.
Omerosreported in August that the FDAgranted orphan drug designation to OMS721 for the treatment of IgA nephropathy. The FDAhas also granted breakthrough therapy designation to OMS721 for the treatment of IgA nephropathy. In Europe, Omerosis pursuing orphan designation and Priority Medicines (PRIME) status from the European Medicines Agency(EMA) for OMS721 in the treatment of IgA nephropathy.
Omerosannounced the presentation by a trial investigator of a case report of a patient having co-existing HSCT-TMA and graft-versus-host disease (GvHD), which both resolved following OMS721 treatment. This case was presented at the European Society for Blood and Marrow Transplantation Crash Course on Diagnosis and Treatment of Noninfectious Complications after HCT in Granada, Spain. The company plans to initiate a Phase 3 clinical program in HSCT-TMA before year-end. Omerosis also pursuing breakthrough therapy designation from FDAand PRIME status from the EMA in this indication.
Omerosannounced the presentation at the American Society of Nephrology Conferenceof follow-up data on the four IgA nephropathy patients in the open-label portion of the Phase 2 trial. As previously reported, all four patients demonstrated a substantial reduction in proteinuria during the clinical trial. In the extended (up to one year) follow-up after completion, proteinuria reduction was maintained in three of the four patients. Specifically, those three patients maintained partial remission relative to baseline (76 percent to 86 percent decrease in albumin/creatinine ratios (uACRs)) during extended follow-up. After a substantial drop in uACR during the trial, the fourth patient’s uACR returned to 88 percent of baseline at four months post-treatment. eGFR improved in three of the four patients during the extended follow-up, with increases ranging from 7 to 17 mL/min/1.73 m2 (up to 57 percent improvement) relative to baseline. The fourth patient demonstrated stable eGFR relative to baseline. OMS721 was well-tolerated.
Omerossold 3.0 million shares of common stock in a public offering with a price to the public of $22.75per share, receiving net proceeds of $63.6 million.
Omerosextended the borrowing capacity under its existing credit facility allowing the company to borrow, at its sole discretion, up to $45.0 millionthrough March 21, 2018subject only to customary closing conditions.
For the quarter ended
Total costs and expenses for the three months ended
Interest expense 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 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.
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,” “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, 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
|UNAUDITED CONSOLIDATED STATEMENTS OF OPERATIONS|
|(In thousands, except share and per share data)|
|Three Months Ended||Nine Months Ended|
|September 30,||September 30,|
|Product sales, net||$||21,658||$||11,289||$||51,067||$||28,539|
|Costs and expenses:|
|Cost of product sales||184||378||613||1,032|
|Research and development||14,835||12,492||40,212||38,157|
|Selling, general and administrative||11,749||10,457||40,016||31,942|
|Total costs and expenses||26,768||23,327||80,841||71,131|
|Loss from operations||(5,110||)||(12,038||)||(29,774||)||(42,419||)|
|Other income (expense), net||408||211||1,010||673|
|Basic and diluted net loss per share||$||(0.16||)||$||(0.34||)||$||(0.83||)||$||(1.19||)|
Weighted-average shares used to compute basic and diluted net loss per share
|UNAUDITED CONSOLIDATED BALANCE SHEET DATA|
|September 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||86,813||$||45,331|
|Restricted cash and investments||5,835||5,835|
|Total current liabilities||24,690||16,071|
|Notes payable and lease financing obligations||83,146||79,710|
|Total shareholders’ equity/ (deficit)||9,211||(37,447||)|
Cook Williams Communications, Inc.
Jennifer Cook Williams, 360-668-3701
Investor and Media Relations