– 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 third quarter ended September 30,
2022, which include:
- For the quarter ended September 30, 2022, we earned royalties
of $16.5 million on net sales of our former ophthalmology product
OMIDRIA®. Royalties earned in the quarter represent 50 percent of
net sales of OMIDRIA by Rayner Surgical, Inc. (Rayner), which
purchased our ophthalmology assets in December 2021. Rayner’s U.S.
net sales of OMIDRIA were $33.0 million for the third quarter of
2022.
- Net loss in 3Q 2022 was $17.5 million, or $0.28 per share,
which included $4.6 million of non-cash expenses, or $0.07 per
share. This compares to a net loss of $22.7 million, or $0.36 per
share for the prior year quarter, which included $6.4 million of
non-cash expenses, or $0.10 per share.
- On September 30, 2022, we sold to DRI Healthcare Acquisitions
LP (DRI) an interest in a portion of our future OMIDRIA royalty
receivables for a cash purchase price of $125.0 million. The
purchased royalty interest entitles DRI to receive royalty payments
on OMIDRIA net sales between September 1, 2022 and December 31,
2030, up to the amount of maximum caps established for each annual
period. The maximum aggregate payout DRI is entitled to receive is
$188.4 million.
- At September 30, 2022, we had $221.0 million of cash, cash
equivalents and short-term investments.
- As announced yesterday, we received the decision by FDA’s
Office of New Drugs (OND) denying our appeal of the complete
response letter (CRL) issued earlier by FDA concerning the
biologics license application (BLA) for narsoplimab in
hematopoietic stem cell transplant-associated microangiopathy
(TA-TMA). Although our request for immediate resubmission and
labeling discussions was denied, the decision proposes a path
forward for resubmission of the BLA based on survival data from the
completed pivotal trial versus a historical control group, with or
without an independent literature analysis.
- In November 2022, the Centers for Medicare and Medicaid
Services (CMS) issued its final Hospital Outpatient Prospective
Payment and Ambulatory Surgical Center Payment Systems rule for
calendar year 2023. The rule confirms that for calendar year 2023
CMS will continue to pay separately for OMIDRIA when used in
ambulatory surgical centers.
“FDA’s decision on our CRL appeal request provides paths forward
that are based on a comparison of patient survival in our pivotal
trial to historical survival data in TA-TMA and to response data in
the literature. Together with our regulatory and legal advisors, we
are assessing potential next steps and look forward to working with
the Agency to approve narsoplimab as quickly as possible,” said
Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive
officer. “Also heading into 2023, we have established financial
flexibility with our royalty monetization transaction, which could
be further strengthened by our receipt of the $200-million
OMIDRIA-related milestone payment. From our clinical trials,
throughout the coming year we anticipate data from our MASP-3
inhibitor OMS906 in PNH and C3 glomerulopathy beginning in the
first quarter, from our Phase 1 program for our long-acting MASP-2
inhibitor in the second quarter and, in mid-year, from our
narsoplimab Phase 3 trial in IgA nephropathy. We also expect news
from our OMS527 PDE7 inhibitor and immuno-oncology programs. All of
these assets are rapidly advancing – collectively representing
significant opportunities and substantial enterprise value.”
Third Quarter and Recent Clinical Developments
- Recent developments regarding narsoplimab, our 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:
- On October 18, 2021, we announced the receipt of a CRL from FDA
indicating that the BLA for narsoplimab in TA-TMA could not be
approved as submitted. Following additional interactions with FDA
regarding the BLA we submitted a Formal Dispute Resolution Request,
in June 2022, appealing the issuance of the CRL to a higher level
within FDA, in this case OND, and requesting that OND direct the
review division to accept a Class 1 resubmission of the BLA and to
commence labeling discussions immediately thereafter. In November
2022, we received OND’s decision denying our appeal. Although our
request for immediate resubmission and labeling discussions was
denied, the decision proposes a path forward for the resubmission
of the BLA based on survival data from the completed pivotal trial
versus a historical control group. Specifically, the decision
proposes the resubmission of the narsoplimab BLA including a
comparison of the existing response data from the completed pivotal
trial to a threshold derived from an independent literature
analysis and evidence of increased survival from patients in the
pivotal trial compared to an appropriate historical control group.
It also notes that persuasive evidence of superior survival versus
a well-matched historical control group could be sufficient even in
the absence of the independent literature analysis. The specific
approach to any resubmission and its details would be determined
through discussion with the review division.
- Enrollment in our Phase 3 ARTEMIS-IGAN trial continues to
progress toward an anticipated readout of 9-month data on
proteinuria by mid-next year.
- A case report describing the successful treatment of an adult
patient with recurrent IgA nephropathy under compassionate use was
presented at the American Society of Nephrology’s kidney week
congress held last week in Orlando, Florida. The poster
presentation is entitled Narsoplimab Treatment for Recurrent IgA
Nephropathy Stabilized eGFR and Proteinuria.
- A poster presentation describing the design of our open-label
Phase 2 study evaluating efficacy and safety of narsoplimab in
pediatric patients with high-risk TA-TMA will be presented at the
annual meeting of the American Society of Hematology to be held in
December 2022 in New Orleans, Louisiana.
- In September 2022, results of the narsoplimab treatment arm of
the I-SPY COVID-19 adaptive platform trial sponsored by Quantum
Leap Healthcare Collaborative were announced. Although the
narsoplimab treatment arm was terminated prior to accrual of the
maximum of 125 patients, analysis in the randomized patient
population showed that the addition of narsoplimab to treatment of
critically ill patients with COVID-19 reduces the mortality risk
(hazard ratio [HR]=0.81, with probability [HR <1] equal to
0.77). In approximately half of the patients who died in the
narsoplimab group, narsoplimab was not given or was prematurely
stopped, with those patients dying 9 to 35 days later. Neither the
trial’s futility nor graduation criteria had been met in the
analysis of the randomized population at the time the narsoplimab
arm was terminated; however, Quantum Leap’s data monitoring
committee terminated the narsoplimab treatment arm on the basis of
analysis in a population of pre-consented patients in which
substantial imbalance was detected, resulting in a marked bias
against the narsoplimab arm.
- Recent developments regarding OMS906, our lead monoclonal
antibody targeting MASP-3, the key activator of the alternative
pathway, and OMS1029, the company’s long-acting, next-generation
MASP-2 inhibitor, include the following:
- We expect soon to begin enrolling patients in a Phase 1b
clinical trial evaluating OMS906 in patients with paroxysmal
nocturnal hemoglobinuria (PNH) who have had an unsatisfactory
response to the C5 inhibitor ravulizumab. Regulatory submissions
and site selection are also progressing on a planned expansion of
clinical programs designed to evaluate OMS906 in treatment-naïve
PNH patients, patients with complement 3 (C3) glomerulopathy and,
potentially, patients with one or more related indications. Initial
efficacy data from these open-label studies are targeted for
availability in early 2023.
- A poster presentation describing the results of a Phase 1
single-ascending-dose clinical trial of OMS906 in normal human
volunteers will be featured at the annual meeting of the American
Society of Hematology to be held in December 2022 in New Orleans,
Louisiana.
- A Phase 1 clinical trial assessing safety, tolerability and
pharmacokinetics/pharmacodynamics (PK/PD) of OMS1029 in healthy
subjects is underway, with dosing of the first three of six cohorts
in the single-ascending-dose study now complete. Dosing of OMS1029
is expected to be once-monthly to once-quarterly by subcutaneous or
intravenous administration. This next-generation MASP-2 inhibitor
is intended as complementary to narsoplimab, enabling us to pursue
both acute and chronic indications and to provide a significant
benefit of dosing convenience to patients.
Financial Results
On September 30, 2022, we sold to DRI an interest in a portion
of our future OMIDRIA royalty receivables in exchange for $125.0
million in cash consideration. DRI is entitled to receive royalties
on OMIDRIA net sales between September 1, 2022 and December 31,
2030, up to the amount of a fixed annual cap. DRI receives payment
of royalties monthly, as received from Rayner, up to the amount of
a prorated monthly cap amount before we receive any royalty
proceeds. DRI is not entitled to carry-forward nor recoup any
shortfall if the royalties paid by Rayner for an annual period are
less than the cap amount for the applicable calendar year.
Additionally, DRI has no recourse to or security interest in our
assets other than our OMIDRIA royalty receivables. We retain all
royalty receipts in excess of the respective cap in any given year.
The maximum aggregate payout DRI is entitled to receive is $188.4
million which, if fully paid, is an effective interest rate of
9.4%. The maximum amount payable for the remainder of 2022 is $1.7
million. The maximum amount payable in 2023 is $13.0 million.
Assuming the maximum amount is paid each year, DRI will recoup the
$125 million purchase price in August 2028.
During the third quarter of 2022, we earned royalties of $16.5
million on sales of OMIDRIA, which were recorded as a reduction
from the OMIDRIA contract royalty asset. We also recorded $37.3
million of income in discontinued operations, primarily
representing interest income and remeasurement adjustments to the
OMIDRIA contract royalty asset.
Total costs and expenses for the third quarter of 2022 were
$50.8 million compared to $39.8 million for the third quarter of
2021. The increase was primarily due to the manufacturing of
narsoplimab drug substance in the third quarter of 2022 for future
commercial and clinical use.
Net loss was $17.5 million in the third quarter of 2022, or
$0.28 per share, which included $4.6 million of non-cash expenses,
or $0.07 per share. This compares to a net loss of $22.7 million,
or $0.36 per share, including $6.4 million of non-cash expenses, or
$0.10 per share, in 3Q 2021.
As of September 30, 2022, we had $221.0 million of cash, cash
equivalents and short-term investments.
Conference Call Details
To access the live conference call via phone, participants must
register at the following link to receive a unique PIN:
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Once registered, you will have two options: (1) Dial in to the
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For online access to the live or subsequently archived webcast
of the conference call, go to Omeros’ 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 disorders including complement-mediated
diseases, cancers, and 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 (TA-TMA).
Narsoplimab is also in multiple late-stage clinical development
programs focused on other complement-mediated disorders, including
IgA nephropathy, COVID-19, and atypical hemolytic uremic syndrome.
Omeros’ long-acting MASP-2 inhibitor OMS1029 is currently in a
Phase 1 clinical trial. OMS906, Omeros’ inhibitor of MASP-3, the
key activator of the alternative pathway of complement, is
advancing in clinical programs for paroxysmal nocturnal
hemoglobinuria (PNH), complement 3 (C3) glomerulopathy and one or
more related indications. 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 statements regarding
prospects for obtaining FDA approval of narsoplimab in TA-TMA and
potential next steps in relation to the biologics license
application for narsoplimab following the receipt of FDA’s decision
on Omeros’ formal dispute resolution request, expectations
regarding the initiation or continuation of clinical trials
evaluating Omeros’ drug candidates and the anticipated availability
of data therefrom, and expectations regarding growth in
royalty-generating sales, 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, 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
CONDENSED CONSOLIDATED
STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share
and per share data)
(unaudited)
Three Months Ended
Nine Months Ended
September 30,
September 30,
2022
2021
2022
2021
Costs and expenses:
Research and development
$
38,568
$
25,818
$
86,172
$
88,448
Selling, general and administrative
12,198
14,010
37,079
42,280
Total costs and expenses
50,766
39,828
123,251
130,728
Loss from continuing operations
(50,766
)
(39,828
)
(123,251
)
(130,728
)
Interest expense
(4,932
)
(4,911
)
(14,799
)
(14,718
)
Interest and other income
906
461
2,069
1,212
Net loss from continuing operations
(54,792
)
(44,278
)
(135,981
)
(144,234
)
Net income from discontinued operations
(1)
37,336
21,575
54,665
57,848
Net loss
$
(17,456
)
$
(22,703
)
$
(81,316
)
$
(86,386
)
Basic and diluted net income (loss) per
share:
Net loss from continuing operations
$
(0.87
)
$
(0.70
)
$
(2.17
)
$
(2.32
)
Net income from discontinued operations
(1)
0.59
0.34
0.87
0.93
Net loss
$
(0.28
)
$
(0.36
)
$
(1.30
)
$
(1.39
)
Weighted-average shares used to compute
basic and diluted net income (loss) per share
62,730,015
62,510,727
62,728,276
62,267,557
(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 for the three and nine months ended
September 30, 2021 in our financial statements.
OMEROS CORPORATION
CONDENSED CONSOLIDATED BALANCE
SHEET DATA
(In thousands)
(unaudited)
September 30,
December 31,
2022
2021
Cash, cash equivalents and short-term
investments
$
220,964
$
157,266
OMIDRIA contract royalty asset
191,385
184,570
Total assets
457,551
419,268
Total current liabilities
39,514
51,789
Lease liabilities
27,942
34,381
Unsecured convertible senior notes,
net
314,819
313,458
OMIDRIA royalty obligation
125,000
—
Total shareholders’ equity (deficit)
(46,314
)
23,780
Working capital
249,031
196,167
OMEROS CORPORATION
CONDENSED CONSOLIDATED
SUPPLEMENTAL DATA
(In thousands)
(unaudited)
The following schedule presents a
rollforward of the OMIDRIA contract royalty asset:
OMIDRIA contract royalty asset at December
31, 2021
$
184,570
Royalties earned
(47,555
)
Royalty interest income and other
23,857
Remeasurement adjustments
30,513
OMIDRIA contract royalty asset at
September 30, 2022
$
191,385
Net income from discontinued operations is
as follows:
Three Months Ended
Nine Months Ended
September 30,
September 30,
2022
2021
2022
2021
(In thousands)
Product sales, net
$
—
$
30,004
$
—
$
79,888
Royalty interest income
8,229
—
23,857
—
Remeasurement adjustments
29,043
—
30,513
—
Other income (expenses), net
64
(8,429
)
295
(22,040
)
Net income from discontinued
operations
$
37,336
$
21,575
$
54,665
$
57,848
View source
version on businesswire.com: https://www.businesswire.com/news/home/20221109006015/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
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