– 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,
immunologic diseases (e.g., complement-mediated diseases and
cancers) and central nervous system disorders, today announced
recent highlights and developments as well as financial results for
the first quarter ended March 31, 2021, which include:
- OMIDRIA revenues for the first quarter of 2021 were $21.1
million compared to $10.6 million in the fourth quarter of 2020.
The increase over the prior quarter reflects limited fourth-quarter
sales due to delayed confirmation (issued in December) by the
Centers for Medicare and Medicaid Services (CMS) that OMIDRIA®
(phenylephrine and ketorolac intraocular solution) 1%/0.3% receives
separate payment when used in the ambulatory surgery center (ASC)
setting.
- Net loss in the first quarter of 2021 was $35.1 million, or
$0.57 per share, including non-cash expenses of $4.1 million, or
$0.07 per share. This compares to a net loss of $37.3 million, or
$0.60 per share, which included non-cash expenses of $3.5 million,
or $0.07 per share, for the previous quarter.
- At March 31, 2021, Omeros had cash, cash equivalents and
short-term investments available for operations of $100.5
million.
- Dosing of patients with narsoplimab in the I-SPY COVID-19
platform trial began in March 2021. The platform trial, sponsored
by Quantum Leap Healthcare Collaborative and partly funded by
BARDA, is enrolling patients nationwide to evaluate potential
therapies for the treatment of critically ill COVID-19
patients.
- Omeros’ Biologics License Application (BLA) for narsoplimab in
the treatment of hematopoietic stem cell transplant-associated
thrombotic microangipathy (HSCT-TMA or TA-TMA) is under priority
review by the U.S. FDA with an action date of July 17, 2021 under
the Prescription Drug User Fee Act (PDUFA).
- In late April, the Centers for Disease Control and Prevention
(CDC) and CMS approved a new ICD-10 diagnosis code for TA-TMA,
creating a disease-specific code by which facilities will bill for
services, and two new ICD-10 procedural codes that allow physicians
to bill for the administration of narsoplimab.
“2021 is off to a strong start as we make great progress toward
the anticipated launch of narsoplimab for TA-TMA while building
momentum with our ophthalmic drug OMIDRIA following CMS’
confirmation of separate payment for OMIDRIA in the ASC setting,”
said Gregory A. Demopulos, M.D., Omeros’ chairman and chief
executive officer. “Narsoplimab dosing is well underway in the
I-SPY COVID-19 platform trial, and the need for a therapeutic to
treat critically ill COVID-19 patients is receiving increased focus
from both U.S. and international agencies. Looking further across
our franchise of complement inhibitors, two other narsoplimab Phase
3 programs are running in IgA nephropathy and aHUS, we expect
initial data readout next month from the Phase 1 trial of our
MASP-3 inhibitor OMS906, and our subcutaneously delivered
long-acting MASP-2 inhibitor OMS1029 is slated to enter the clinic
in the first half of next year. Our preclinical programs are also
progressing, led by our efforts to deliver a GPR174 inhibitor to
the clinic as quickly as possible. With the PDUFA date for
narsoplimab in TA-TMA rapidly approaching, we remain committed to
bringing a long line of important, first-in-class drugs to
market.”
First Quarter and Recent Developments
- Recent developments regarding OMIDRIA include the following:
- Omeros continued to add new ASC customers in the first quarter
of 2021, including seven large ASC chains and private equity
groups. The total number of purchasing ASCs increased by 43% in the
first quarter over the previous quarter.
- A manuscript on pain control and reduction of opioid use
intraoperatively with the use of OMIDRIA during cataract surgery
has been submitted for publication. Another manuscript on the
perioperative use of opioids in cataract surgery pain management
and the role of non-opioid alternatives like OMIDRIA has also been
submitted for publication.
- The Non-Opioids Prevent Addiction in the Nation (NOPAIN) Act
has been re-introduced in the Senate. The NOPAIN Act would extend
separate payment for non-opioid alternatives like OMIDRIA in both
ASCs and hospital outpatient departments on a renewable five-year
basis. Currently, OMIDRIA is separately paid in the ASC
setting.
- Recent developments regarding narsoplimab, Omeros’ lead human
monoclonal antibody targeting mannan-binding lectin-associated
serine protease-2 (MASP-2) in advanced clinical programs for the
treatment of TA-TMA, immunoglobulin A (IgA) nephropathy, atypical
hemolytic uremic syndrome (aHUS) and critically ill COVID-19
patients, include the following:
- Data from the pivotal trial of narsoplimab in TA-TMA was
featured in a podium presentation at the annual European Society
for Blood and Marrow Transplantation (EBMT) meeting in March.
- An abstract on narsoplimab treatment in adults with high-risk
TA-TMA has also been accepted for oral presentation at the 2021
Congress of the European Hematology Association (EHA) in June.
- Discussions with the U.S. and foreign governments regarding
funding and manufacturing support for narsoplimab are ongoing.
- Updates regarding Omeros’ other development programs and
platforms include the following:
- Omeros has completed all of the intravenous cohorts and the
first subcutaneous dosing cohort in the single-ascending-dose study
in its Phase 1 clinical trial evaluating OMS906, the company’s
inhibitor of MASP-3, the key activator of the alternative pathway
of complement. Initial data from the placebo-controlled,
double-blind, single-ascending-dose and multiple-ascending-dose
trial are expected later this quarter.
- A paper detailing the mechanism of action of PDE7 inhibition in
nicotine addiction will soon be published in the peer-reviewed
Journal of Neuroscience. Omeros has completed a successful Phase 1
trial with OMS527, its PDE7 inhibitor.
Financial Results
For the first quarter of 2021, OMIDRIA revenues were $21.1
million compared to $10.6 million for the fourth quarter of 2020.
The uncertainty around OMIDRIA’s reimbursement status affected
revenues in the fourth quarter and extending into early February
2021.
Total costs and expenses for the first quarter of 2021 were
$51.7 million compared to $47.2 million for the first quarter of
2020. The increase was primarily due to research and development
expenses related to narsoplimab manufacturing. Until approval for
narsoplimab in TA-TMA is certain, manufacturing costs for
narsoplimab are expensed as incurred instead of included as
inventory.
For the three months ended March 31, 2021, Omeros reported a net
loss of $35.1 million, or $0.57 per share, which included non-cash
expenses of $4.1 million, or $0.07 per share. This compares to a
net loss in the previous quarter of $37.3 million, or $0.60 per
share, which included non-cash expenses of $3.5 million, or $0.07
per share.
As of March 31, 2021, the company had $100.5 million of cash,
cash equivalents and short-term investments. The company also has a
line of credit, which permits borrowing up to the lesser of 85
percent of eligible accounts receivable less certain reserves and
$50.0 million.
On March 1, 2021, the company entered into an “at the market”
sales agreement which allows the company to sell, from time to
time, up to $150.0 million of its common stock.
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 6999269. 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 6999269.
To access the live or subsequently archived webcast of the
conference call on the internet, go to the company’s website at
https://investor.omeros.com/upcoming-events.
About Omeros Corporation
Omeros is a commercial-stage biopharmaceutical company committed
to discovering, developing and commercializing small-molecule and
protein therapeutics for large-market and orphan indications
targeting inflammation, immunologic diseases (e.g.,
complement-mediated diseases and cancers) and central nervous
system disorders. Its commercial product OMIDRIA® (phenylephrine
and ketorolac intraocular solution) 1%/0.3% continues to gain
market share in cataract surgery. Omeros’ lead MASP-2 inhibitor
narsoplimab targets the lectin pathway of complement and is the
subject of a biologics license application under priority review by
FDA for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy. Narsoplimab is
also in multiple late-stage clinical development programs focused
on other complement-mediated disorders, including IgA nephropathy,
atypical hemolytic uremic syndrome and COVID-19. OMS906, Omeros’
inhibitor of MASP-3, the key activator of the alternative pathway
of complement, is in a Phase 1 clinical trial, and the company’s
PDE7 inhibitor program OMS527, targeting addiction and movement
disorders, has successfully completed a Phase 1 trial. Omeros’
pipeline holds a diverse group of preclinical programs including a
proprietary-asset-enabled antibody-generating technology and a
proprietary GPCR platform through which it controls 54 GPCR drug
targets and their corresponding compounds. One of these novel
targets, GPR174, modulates a new cancer immunity axis recently
discovered by Omeros, and the company is advancing GPR174-targeting
antibodies and small-molecule inhibitors.
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,” “objective,”
“plan,” “potential,” “predict,” “project,” “should,” “slate,”
“target,” “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, the impact of COVID-19 on our business,
financial condition and results of operations, regulatory processes
and oversight, challenges associated with manufacture or supply of
our investigational or commercial products, changes in
reimbursement and payment policies by government and commercial
payers or the application of such policies, intellectual property
claims, competitive developments, litigation, and the risks,
uncertainties and other factors described under the heading “Risk
Factors” in the company’s Annual Report on Form 10-K filed with the
Securities and Exchange Commission (SEC) on March 1, 2021. 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,
whether as a result of new information, future events or otherwise,
except as required by applicable law.
OMEROS CORPORATION
UNAUDITED CONSOLIDATED
STATEMENTS OF OPERATIONS
(In thousands, except share
and per share data)
Three Months Ended
March 31,
2021
2020
Revenue:
Product sales, net
$
21,061
$
23,537
Costs and expenses:
Cost of product sales
263
267
Research and development
33,358
28,911
Selling, general and administrative
18,052
18,036
Total costs and expenses
51,673
47,214
Loss from operations
(30,612
)
(23,677
)
Interest expense
(4,897
)
(5,903
)
Other income
419
549
Net loss
$
(35,090
)
$
(29,031
)
Comprehensive loss
$
(35,090
)
$
(29,031
)
Basic and diluted net loss per share
$
(0.57
)
$
(0.53
)
Weighted-average shares used to compute
basic and diluted net loss per share
61,928,511
54,299,813
OMEROS CORPORATION
UNAUDITED CONSOLIDATED BALANCE
SHEET DATA
(In thousands)
March 31,
December 31,
2021
2020
Cash, cash equivalents and short-term
investments
$
100,483
$
134,953
Working capital
89,048
114,549
Restricted investments
1,054
1,055
Total assets
161,444
181,042
Total current liabilities
43,434
36,736
Lease liabilities
31,609
32,552
Unsecured convertible senior notes,
net
312,159
236,288
Accumulated deficit
(912,459
)
(872,672
)
Total shareholders’ deficit
(221,955
)
(120,752
)
View source
version on businesswire.com: https://www.businesswire.com/news/home/20210510005882/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations 360.668.3701 jennifer@cwcomm.org
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