– Conference Call Today at 4:30 p.m. ET
–
Omeros Corporation (Nasdaq: OMER), a clinical-stage
biopharmaceutical company committed to discovering, developing and
commercializing small-molecule and protein therapeutics for
large-market as well as orphan indications targeting inflammation
and immunologic diseases, including complement-mediated diseases
and cancers, today announced recent highlights and developments as
well as financial results for the first quarter ended March 31,
2022, which include:
- On December 23, 2021, Omeros completed the sale of its
commercial ophthalmic product OMIDRIA® (phenylephrine and ketorolac
intraocular solution) 1%/0.3% and certain related assets and
liabilities to Rayner Surgical Inc. (“Rayner”). As a result of the
transaction, the company reclassified all revenues and expenses
related to OMIDRIA to discontinued operations for fiscal year 2021
in its financial statements. Omeros is entitled to royalties on
Rayner’s worldwide net sales of OMIDRIA at rates that vary based on
geography and certain regulatory contingencies. The royalty rate
for U.S. net sales of OMIDRIA is currently 50 percent.
- For the quarter ended March 31, 2022, Omeros earned royalties
of $13.8 million based on Rayner’s net sales of $27.7 million, all
of which were in the U.S. This is a $6.6 million increase from the
$21.1 million of OMIDRIA net sales reported by Omeros in the prior
year quarter.
- Net loss was $33.0 million in the current quarter, or $0.53 per
share, which included $4.2 million of non-cash expenses, or $0.07
per share. This compares to a net loss of $35.1 million, or $0.57
per share for the prior year quarter, which included $4.1 million
of non-cash expenses, or $0.07 per share.
- At March 31, 2022, Omeros had $142.2 million of cash, cash
equivalents and short-term investments available for operations,
which is a reduction of $15.0 million from December 31, 2021. In
addition, at March 31, 2022 Omeros had $16.3 million in
receivables, consisting primarily of OMIDRIA royalties related to
the first quarter, which are due for payment this month.
- In February 2022, Omeros had a Type A post-action meeting with
the United States Food and Drug Administration (FDA) to discuss the
Complete Response Letter (CRL) issued by FDA last year regarding
the Company’s biologics license application (BLA) for narsoplimab
in the treatment of hematopoietic stem cell transplant-associated
thrombotic microangiopathy (TA-TMA). FDA was delayed in providing
official minutes of the meeting, in which the review division
repeated a number of critiques that the Company felt had been
adequately addressed or were inaccurate. After close consultation
with outside legal and regulatory advisors, Omeros has prepared and
expects soon to submit a request for formal dispute resolution.
Formal dispute resolution is an official pathway that enables a
sponsor to appeal a decision by an FDA division to a higher
authority within FDA, in this case the Office of New Drugs. Omeros’
request is for regular approval based on the data in the existing
BLA.
“Following our Type A post-action meeting with FDA and preparing
our draft request for formal dispute resolution, we remain highly
confident in the strength of our data and of the entirety of our
BLA,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief
executive officer. “We believe that the BLA warranted approval last
year and, given the immediate patient need for narsoplimab, that
formal dispute resolution represents the most expeditious path to
approval. We now are finalizing the request with our team of
regulatory and legal advisors and expect to submit it within a
couple of weeks. Physician support is broad, our case for appeal is
strong, and we expect to be successful. In addition to our focus on
regulatory approval, we believe that there are a series of
value-creating events throughout the remainder of 2022, including
OMS906 data in patients with paroxysmal nocturnal hemoglobinuria,
data from our efforts in COVID-19, as well as updates on our Phase
1 study evaluating our long-acting MASP-2 inhibitor OMS1029,
completion of enrollment for the proteinuria endpoint in our
narsoplimab ARTEMIS-IgAN trial, and the potential to earn an
OMIDRIA-related $200 million commercial milestone payment.”
First Quarter and Recent Developments
•
Recent developments regarding narsoplimab, Omeros’ lead 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 severely ill COVID-19 patients, include
the following:
°
In April 2022, a manuscript detailing the
results of Omeros’ pivotal study assessing efficacy and safety of
narsoplimab for the treatment of TA-TMA was published in the
Journal of Clinical Oncology (JCO), the flagship publication of the
American Society of Clinical Oncology. The manuscript, entitled
“Narsoplimab, a Mannan-Binding Lectin-Associated Serine Protease-2
Inhibitor, for the Treatment of Adult Hematopoietic Stem-Cell
Transplantation–Associated Thrombotic Microangiopathy” is available
online and will be included in an upcoming print volume of JCO.
°
Omeros engaged with key stakeholders in
the transplant community through its presence at TANDEM 2022, the
joint annual meetings of the American Society for Transplantation
and Cellular Therapy (ASTCT) and the Center for International Blood
& Marrow Transplant Research (CIBMTR), which was held last
month in Salt Lake City. As part of the conference, Omeros received
an award from the President of ASTCT in recognition of Omeros’ work
in raising awareness of TA-TMA and advancing the medical and
scientific understanding in the field.
°
Narsoplimab is also being evaluated for
the treatment of hospitalized COVID-19 patients in the I-SPY
COVID-19 platform trial sponsored by Quantum Leap Healthcare
Collaborative. To date, no drug investigated in the trial has been
reported to show a benefit relative to the background therapy in
the trial. Quantum’s analysis of the narsoplimab data is being
finalized, and we all look forward to sharing the outcome of the
trial.
°
Enrollment in Omeros’ Phase 3 Artemis IgAN
trial continues to progress towards an anticipated read out of
9-month follow-up data on proteinuria in the first half of next
year. Our investigational new drug application for narsoplimab in
IgAN has now been approved by the Chinese regulatory authority. We
look forward to completing the remaining regulatory requirements
and initiating enrollment there as soon as possible.
Recent developments regarding OMS906, Omeros’ lead clinical
monoclonal antibody targeting MASP-3, the key activator of the
alternative pathway, and OMS1029, the company’s long-acting MASP-2
inhibitor, include the following:
°
Omeros continues its preparations to
initiate a Phase 1b trial of OMS906 in patients with paroxysmal
nocturnal hemoglobinuria (PNH). Enrollment is expected to begin
this summer. As previously disclosed, dosing in the
single-ascending-dose study of OMS906 in healthy subjects is
completed. There were no safety signals of concern, and
pharmacokinetic/pharmacodynamic (PK/PD) data support once-monthly
to once-quarterly subcutaneous or intravenous dosing.
°
Preparations are also underway for a Phase
1 trial assessing safety and tolerability and PK/PD of OMS1029 in
healthy human subjects. First-in-human-enabling toxicology studies
are complete and there was no safety signal of concern. Dosing in
humans is expected to be once-monthly to once-quarterly by
subcutaneous or intravenous administration based on animal PK/PD
data to date. Enrollment is targeted to begin this summer.
Financial Results
On December 23, 2021, Rayner acquired OMIDRIA and the associated
business operations. The completion of the sale required Omeros to
reclassify all revenues and expenses related to OMIDRIA to
discontinued operations for fiscal year 2021 in its financial
statements.
Upon closing of the sale of OMIDRIA, Omeros recorded an OMIDRIA
contract royalty asset of $184.6 million representing the minimum
expected net present value of future U.S. royalty payments. During
the first quarter of 2022, we earned royalties of $13.8 million on
sales of OMIDRIA which we recorded as a reduction to the OMIDRIA
contract royalty asset. We also recorded $7.0 million of income in
discontinued operations representing interest income and
remeasurement adjustments to the OMIDRIA contract royalty
asset.
Total costs and expenses for the first quarter of 2022 were
$35.0 million compared to $45.3 million for the first quarter of
2021. The decrease was primarily due to reduced narsoplimab
manufacturing activities and reduced narsoplimab pre-launch
marketing activities.
Net loss was $33.0 million in the first quarter of 2022, or
$0.53 per share, which included $4.2 million of non-cash expenses,
or $0.07 per share. This compares to 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.
As of March 31, 2022, the company had $142.2 million of cash,
cash equivalents and short-term investments, a reduction of $15.0
million from December 31, 2021, and $16.3 million in receivables,
net.
Conference Call Details
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 1198541. 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
1198541.
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 an innovative biopharmaceutical company committed to
discovering, developing and commercializing small-molecule and
protein therapeutics for large-market and orphan indications
targeting immunologic diseases, including complement-mediated
diseases and cancers related to dysfunction of the immune system,
as well as addictive and compulsive disorders. Omeros’ lead MASP-2
inhibitor narsoplimab targets the lectin pathway of complement and
is the subject of a biologics license application pending before
FDA for the treatment of hematopoietic stem cell
transplant-associated thrombotic microangiopathy (HSCT-TMA).
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 initiating a Phase 1b
clinical program in paroxysmal nocturnal hemoglobinuria (PNH). For
more information about Omeros and its programs, visit
www.omeros.com.
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, including expectations with
regard Omeros’ pursuit of regulatory approval for narsoplimab in
HSCT-TMA, including expectations regarding submission of a formal
dispute resolution request and the potential or anticipated
outcomes thereof, and expectations regarding the initiation or
continuation of clinical trials evaluating Omeros’ drug candidates
and the anticipated availability of data therefrom, 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, unanticipated or unexpected outcomes of
regulatory processes in relevant jurisdictions, 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
clinical 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 on March 1, 2022. 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,
2022
2021(1)
Costs and expenses:
Research and development
$
24,087
$
32,504
Selling, general and administrative
10,959
12,786
Total costs and expenses
35,046
45,290
Loss from continuing operations
(35,046
)
(45,290
)
Interest expense
(4,941
)
(4,897
)
Other income
493
418
Net loss from continuing operations
(39,494
)
(49,769
)
Net income from discontinued
operations
6,483
14,679
Net loss
$
(33,011
)
$
(35,090
)
Basic and diluted net income (loss) per
share:
Net loss from continuing operations
$
(0.63
)
$
(0.81
)
Net income from discontinued
operations
0.10
0.24
Net loss
$
(0.53
)
$
(0.57
)
Weighted-average shares used to compute
basic and diluted net income (loss) per share
62,724,775
61,928,511
(1)
The sale of OMIDRIA has been accounted for as the sale of an asset.
Accordingly, we have reclassified all revenues and expenses related
to OMIDRIA to net income from discontinued operations the quarter
ending March 31, 2021 in our financial statements.
OMEROS CORPORATION
UNAUDITED CONSOLIDATED BALANCE
SHEET DATA
(In thousands)
March 31,
December 31,
2022
2021
Cash and cash equivalents
$
142,234
$
157,266
OMIDRIA contract royalty asset
177,735
184,570
Total assets
369,263
419,268
Total current liabilities
35,066
51,789
Lease liabilities
28,221
34,381
Unsecured convertible senior notes,
net
313,904
313,458
Total shareholders’ equity (deficit)
(4,925
)
23,780
Working capital
175,156
196,167
OMEROS CORPORATION
UNAUDITED CONSOLIDATED
SUPPLEMENTAL DATA
(In thousands)
The following schedule presents a
rollforward of the OMIDRIA contract royalty asset:
OMIDRIA contract royalty asset at December
31, 2021
$
184,570
Royalties earned
(13,831
)
Royalty interest income and remeasurement
adjustments
6,996
OMIDRIA contract royalty asset at March
31, 2022
$
177,735
Net income from discontinued operations is
as follows:
Three Months Ended March
31,
2022
2021
Product sales, net
$
—
$
21,061
Royalty interest income and remeasurement
adjustments
6,996
—
Total
6,996
21,061
Costs and expenses
513
6,382
Net income from discontinued
operations
$
6,483
$
14,679
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220510006361/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
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