Omeros Corporation Reports Second Quarter 2017 Financial Results
– Conference Call Today at
2Q 2017 total and OMIDRIA® revenues were
$17.2 million. Revenues from OMIDRIA sales rose 40% from 1Q 2017 and 71% from the prior year’s second quarter.
- OMIDRIA units shipped by wholesalers (“sell-through”) increased 34% over 1Q 2017 and 113% over 2Q 2016.
Net loss in 2Q 2017 was
$14.4 million, or $0.33per share, which included $4.3 million( $0.10per share) of non-cash expenses. Net loss in the prior year’s second quarter was $12.6 millionor $0.32per share, which included $3.2 million( $0.08per share) of non-cash expenses.
FDAgranted OMS721 breakthrough therapy and orphan drug designations in immunoglobin A (IgA) nephropathy.
- Initiated OMS721 Phase 3 clinical program in IgA nephropathy; Phase 3 trial is expected to begin later this year.
“OMIDRIA posted a strong quarter as revenues continue to grow across all
sectors of our market – ASCs, community hospitals and academic centers –
and from both new and existing accounts,” said
Second 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) 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
Omerosannounced that the FDAgranted breakthrough therapy designation to OMS721 for the treatment of IgA nephropathy. Breakthrough therapy designation was granted based on data from Omeros’ Phase 2 clinical trial evaluating OMS721 in patients with IgA nephropathy and other kidney diseases. In August, the company announced that the FDAgranted orphan drug designation to OMS721 for the treatment of IgA nephropathy. In addition, in Europethe company is pursuing orphan designation and Priority Medicines (PRIME) designation for the treatment of IgA nephropathy.
Omerosis pursuing from the FDAbreakthrough therapy designation for OMS721 in HSCT-TMA and accelerated approval for OMS721 in one or more of the indications in development, including aHUS. The FDAhas already granted fast track designation for OMS721 in patients with aHUS and orphan designation for OMS721 in patients with complement-mediated TMAs, including aHUS and HSCT-TMA.
The company reported data from its Phase 2 clinical trial of
OMS721 for the treatment of IgA nephropathy and other kidney
diseases at the 54th
European Renal Association-European Dialysisand Transplant Association (ERA-EDTA) Congressin Madrid, Spain.
Following a successful meeting with
FDAregarding positive OMS721 Phase 2 clinical data in patients with IgA nephropathy, Omerosinitiated its Phase 3 program for OMS721 in this indication. Discussions are ongoing with FDAand the Phase 3 clinical trial is expected to begin later this year.
- In June,
Omerosfiled an OMIDRIA supplemental NDA (sNDA) to the FDAto fulfill the Agency’s post-marketing requirement for a pediatric clinical trial. By successfully completing the trial and filing the sNDA, Omerosexpects to expand the drug’s indication and label to include use of OMIDRIA in children and to receive an additional six months of marketing exclusivity for OMIDRIA.
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,” “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||Six Months Ended|
|June 30,||June 30,|
|Product sales, net||$||17,151||$||10,004||$||29,408||$||17,250|
|Costs and expenses:|
|Cost of product sales||157||327||429||654|
|Research and development||13,137||10,231||25,377||25,665|
|Selling, general and administrative||15,796||10,375||28,267||21,485|
|Total costs and expenses||29,090||20,933||54,073||47,804|
|Loss from operations||(11,939||)||(10,929||)||(24,665||)||(30,381||)|
|Other income (expense), net||303||174||603||462|
|Basic and diluted net loss per share||$||(0.33||)||$||(0.32||)||$||(0.67||)||$||(0.86||)|
Weighted-average shares used to compute basic and diluted net loss per share
|UNAUDITED CONSOLIDATED BALANCE SHEET DATA|
|June 30,||December 31,|
|Cash, cash equivalents and short-term investments||$||29,667||$||45,331|
|Restricted cash and investments||5,835||5,835|
|Total current liabilities||24,753||16,071|
|Notes payable and lease financing obligations||81,761||79,710|
|Total shareholders’ deficit||(54,850||)||(37,447||)|
Cook Williams Communications, Inc.
Investor and Media Relations
Jennifer Cook Williams, 360-668-3701