Conference Call Today at 4:30 p.m.
ET
Omeros Corporation (NASDAQ: OMER), 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, today announced recent highlights and developments as well
as financial results for the third quarter ended September 30,
2017, which include:
- 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 $0.16 per share, which included $4.2 million ($0.09 per share)
of non-cash expenses. Net loss in the prior year’s third quarter
was $14.0 million or $0.34 per share, which included $3.1 million
($0.08 per share) of non-cash expenses.
- At September 30, 2017, the company had
cash, cash equivalents and short-term investments available for
operations of $86.8 million plus the ability to borrow an
additional $45.0 million from existing lenders.
- Settled patent infringement lawsuit
against Par Pharmaceutical, Inc. and its affiliate (collectively,
Par) on favorable terms in October 2017.
- Met with FDA in 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.
- FDA granted 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
Omeros. “We have also made substantial progress across our OMS721
programs – in addition to our Phase 3 aHUS program, we have a clear
roadmap for the Phase 3 IgA nephropathy trial, including FDA
confirmation of proteinuria as the primary efficacy endpoint, and
compelling data to support our advancing to a Phase 3 program in
stem cell transplant-associated TMA. Further adding to our clinical
pipeline, OMS527, our PDE7 inhibitor for the treatment of
addictions and compulsive disorders, is on track to enter Phase 1
in the first half of next year.”
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 FDA to 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, 2032 or 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
nephropathy, include:
- Omeros met with the FDA in 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.
- Omeros reported in August that the FDA
granted orphan drug designation to OMS721 for the treatment of IgA
nephropathy. The FDA has also granted breakthrough therapy
designation to OMS721 for the treatment of IgA nephropathy. In
Europe, Omeros is pursuing orphan designation and Priority
Medicines (PRIME) status from the European Medicines Agency (EMA)
for OMS721 in the treatment of IgA nephropathy.
- In October, Omeros announced 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. Omeros is also pursuing breakthrough therapy
designation from FDA and PRIME status from the EMA in this
indication.
- In November, Omeros announced the
presentation at the American Society of Nephrology Conference of
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.
- In August, Omeros sold 3.0 million
shares of common stock in a public offering with a price to the
public of $22.75 per share, receiving net proceeds of $63.6
million.
- In October, Omeros extended the
borrowing capacity under its existing credit facility allowing the
company to borrow, at its sole discretion, up to $45.0 million
through March 21, 2018 subject only to customary closing
conditions.
Financial Results
For the quarter ended September 30, 2017, total revenues were
$21.7 million, all from sales of OMIDRIA. This compares to OMIDRIA
revenues of $11.3 million for the same period in 2016. On a
sequential quarter-over-quarter basis, OMIDRIA revenue grew $4.5
million, or 26 percent, and grew 92 percent year-over-year. The
quarter-over-quarter increases in OMIDRIA revenue and units sold
are due to both an increase in the number of customers purchasing
OMIDRIA and increased penetration into existing customer
accounts.
Total costs and expenses for the three months ended September
30, 2017 were $26.8 million compared to $23.3 million for the same
period in 2016. The increase in the current year quarter was
primarily due to increased third-party manufacturing scale-up costs
associated with OMS721, increased preclinical and development costs
as Omeros continues to advance drug candidates toward the clinic
and increased legal costs associated with the Par lawsuit, which
settled in October 2017 on favorable terms to Omeros.
Interest expense for the three months ended June 30, 2017 was
$2.8 million as compared to $2.1 million in the prior year third
quarter. The increase is due to incremental funds borrowed by the
company in November 2016.
For the three months ended September 30, 2017, Omeros reported a
net loss of $7.5 million, or $0.16 per share, which included
non-cash expenses of $4.2 million ($0.09 per share). This compares
to the prior year’s third quarter where Omeros reported a net loss
of $14.0 million, or $0.34 per share, which included non-cash
expenses of $3.1 million ($0.08 per share).
As of September 30, 2017, the company had $86.8 million of cash
and cash equivalents available for operations and $5.8 million in
restricted cash. The company has the ability, at its sole
discretion, to borrow up to an additional $45.0 million from its
existing lenders through March 21, 2018 subject only to customary
closing conditions.
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 1:30 p.m. Pacific Time; 4:30 p.m.
Eastern Time. To access the live conference call via phone, please
dial (844) 831-4029 from the United States and Canada or (920)
663-6278 internationally. The participant passcode is 8389089.
Please dial in approximately 10 minutes prior to the start of the
call. A telephone replay will be available for one week following
the call and may be accessed by dialing (855) 859-2056 from the
United States and Canada or (404) 537-3406 internationally. The
replay passcode is 8389089.
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.
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 injection) 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; Huntington’s disease
and 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,” “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 Securities and
Exchange Commission on November 9, 2017. 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.
OMEROS CORPORATION UNAUDITED CONSOLIDATED
STATEMENTS OF OPERATIONS (In thousands, except share and per
share data) Three Months Ended
Nine Months Ended September 30, September
30, 2017 2016 2017
2016 Revenues: Product sales, net $ 21,658 $
11,289 $ 51,067 $ 28,539 Grant revenue
— 173 Total revenue
21,658 11,289
51,067 28,712
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 )
Interest expense (2,780 ) (2,135 ) (8,166 ) (5,367 ) Other income
(expense), net
408
211 1,010
673 Net loss
$ (7,482
) $ (13,962 )
$ (36,930 ) $
(47,113 ) 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
46,262,211 41,058,754
44,709,418 39,518,128
OMEROS CORPORATION UNAUDITED CONSOLIDATED BALANCE SHEET
DATA (In thousands) September 30,
December 31, 2017 2016 Cash,
cash equivalents and short-term investments $ 86,813 $ 45,331
Working capital 93,207 44,191 Restricted cash and investments 5,835
5,835 Total assets 125,517 67,278 Total current liabilities 24,690
16,071 Notes payable and lease financing obligations 83,146 79,710
Accumulated deficit (506,817 ) (469,887 ) Total shareholders’
equity/ (deficit) 9,211 (37,447 )
View source
version on businesswire.com: http://www.businesswire.com/news/home/20171109006455/en/
Cook Williams Communications, Inc.Jennifer Cook Williams,
360-668-3701Investor and Media Relationsjennifer@cwcomm.org
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