Accueil / Communiqués / Omeros Corporation Announces Record High Quarterly Revenue Results for the Fourth Quarter 2018

Omeros Corporation Announces Record High Quarterly Revenue Results for the Fourth Quarter 2018

Monday, January 14th 2019 at 12:30pm UTC

Broadening OMIDRIA Coverage from Payers and Increasing Funding for
OMS721 Commercial Preparations

SEATTLE–(BUSINESS WIRE)– Omeros Corporation (Nasdaq: OMER), today announced unaudited preliminary
revenue results for the fourth quarter ended December 31, 2018.

  • Omeros’ preliminary (unaudited) total and OMIDRIA®
    (phenylephrine and ketorolac intraocular solution) 1% / 0.3% revenues
    for the fourth quarter of 2018 are expected to be a record high at
    approximately $22.0 million compared to $4.6 million in 3Q 2018 and
    $13.8 million in the prior year fourth quarter. The increase from the
    prior periods reflects strong demand for OMIDRIA from ambulatory
    surgery centers (ASCs) and hospitals following reinstatement of
    pass-through reimbursement for OMIDRIA on October 1, 2018.
  • As of December 31, 2018, days of wholesaler inventory on hand were
    consistent with historical norms.
  • Increased utilization within commercial insurance and Veterans Health
    Administration systems contributed to the increased revenues.
  • Units sold by wholesalers to ASCs and to hospitals (sell-through) as
    well as the number of purchasing hospital accounts for the fourth
    quarter 2018 each also represent a record high.
  • Annualized run rate of weekly net sales in December was approximately
    $100 million.

Consistent with Omeros’ strategy, growing revenues from OMIDRIA are
increasingly funding the progress across the company’s pipeline,
including the advancement of its OMS721 Phase 3 program in hematopoietic
stem cell transplant-associated thrombotic microangiopathy (HSCT-TMA).
As reflected in an update recently submitted to clinicaltrials.gov,
Omeros plans to keep the ongoing HSCT-TMA registration trial open
through the submission, filing and review of the Biologics License
Application (BLA) and the Marketing Authorization Application (MAA) in
the U.S. and Europe, respectively, to collect additional data. These
data are expected to help provide healthcare professionals and payers
with additional supporting information on the clinical use and value of
OMS721 once approved. The update submitted by Omeros to
clinicaltrials.gov has no effect on the overall timing, content or
requirements of the OMS721 HSCT-TMA program, including the BLA and MAA,
and the program remains on track.

“We are very pleased that demand for OMIDRIA, in its first quarter of
restored separate payment, has not only returned quickly to the levels
experienced prior to the expiration of pass-through reimbursement but
that quarterly revenue and sell-through results are already setting new
high-water marks,” said Gregory A. Demopulos, M.D., Omeros’ chairman and
chief executive officer. “We are also encouraged by the expanding
coverage seen by commercial and Medicare Advantage payers and, with the
addition of OMIDRIA to its national formulary, by the VA. All of these
data underscore the importance both of improved outcomes with OMIDRIA
and of separate payment to ensuring patient access to the drug’s
benefits. As expected, revenues from sales of OMIDRIA ramped up
throughout the fourth quarter, and we look forward to continued revenue
growth in 2019 as we prepare to commercialize OMS721 for the treatment
of stem cell transplant-associated TMA.”

Omeros has released OMIDRIA fourth-quarter preliminary revenues for the
purpose of providing transparency in the unique setting of reinstatement
of pass-through status and does not currently intend in the future to
make public preliminary sales revenues on a routine basis. The company
expects to release complete fourth-quarter and full-year 2018 financial
results and to host a conference call by March 1, 2019.

About Omeros Corporation

Omeros is a commercial-stage biopharmaceutical company committed to
discovering, developing and commercializing small-molecule and protein
therapeutics for large-market as well as orphan indications targeting
inflammation, complement-mediated diseases and disorders of the central
nervous system. The company’s drug product OMIDRIA®
(phenylephrine and ketorolac intraocular solution) 1% / 0.3% is marketed
for use during cataract surgery or intraocular lens (IOL) replacement to
maintain pupil size by preventing intraoperative miosis (pupil
constriction) and to reduce postoperative ocular pain. In the European
Union, the European Commission has approved OMIDRIA for use in cataract
surgery and other IOL replacement procedures to maintain mydriasis
(pupil dilation), prevent miosis (pupil constriction), and to reduce
postoperative eye pain. Omeros has multiple Phase 3 and Phase 2
clinical-stage development programs focused on: complement-associated
thrombotic microangiopathies; complement-mediated
glomerulonephropathies; cognitive impairment; and addictive and
compulsive disorders. In addition, Omeros has a diverse group of
preclinical programs and a proprietary G protein-coupled receptor (GPCR)
platform through which it controls 54 new GPCR drug targets and
corresponding compounds, a number of which are in preclinical
development. The company also exclusively possesses a novel
antibody-generating platform.

Forward-Looking Statements

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,” “prospects,”
“should,” “slated,” “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, the ability for OMIDRIA to obtain separate reimbursement as
part of CMS’ OPPS, 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 Securities and Exchange Commission on
November 8, 2018. Given these risks, uncertainties and other factors,
you should not place undue reliance on these forward-looking statements,
and the company assumes no obligation to update these forward-looking
statements, even if new information becomes available in the future.

Contacts

Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor
and Media Relations
360.668.3701
jennifer@cwcomm.org

Source: Omeros Corporation


Voir aussi

Fishawack poursuit son développement d’une offre de services hors pair avec l’acquisition de Dudnyk

Wednesday, March 20th 2019 at 9:25pm UTC KNUTSFORD, Angleterre–(BUSINESS WIRE)– Fishawack, une importante société experte …