– 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 and orphan indications targeting immunologic disorders
including complement-mediated diseases, cancers, and addictive and
compulsive disorders, today announced recent highlights and
developments as well as financial results for the fourth quarter
and year ended December 31, 2022, which include:
- Net income in the fourth quarter of 2022 was $128.7 million, or
$2.05 per share, compared to a net loss in the third quarter of
2022 of $17.5 million, or $0.28 per share; our fourth quarter’s net
loss from continuing operations was $46.0 million, or $0.73 per
share, compared to $54.8 million, or $0.87 per share, in the third
quarter of 2022. Cash burn for the fourth quarter of 2022 was $26.0
million.
- For the year ended December 31, 2022, net income was $47.4
million, or $0.76 per share. This compares to net income of $194.2
million or $3.12 per share for the year ended December 31,
2021.
- The milestone event specified in the asset purchase agreement
by which we sold our former ophthalmology product OMIDRIA® to
Rayner Surgical, Inc. (“Rayner”) occurred in December 2022,
resulting in us recording as a receivable the $200.0 million
milestone payment from Rayner in December 2022 and receiving the
cash payment in February 2023.
- For the fourth quarter ended December 31, 2022, we earned
OMIDRIA royalties of $17.9 million on Rayner’s U.S. net sales of
$35.8 million, an all-time high for quarterly net sales of OMIDRIA.
This compares to earned royalties of $16.5 million during the third
quarter of 2022. For the year ended December 31, 2022, we earned
royalties of $65.4 million on U.S. net sales of OMIDRIA.
- At December 31, 2022, we had $194.9 million of cash, cash
equivalents and short-term investments. In addition, we had $213.2
million of accounts receivable, substantially all of which have
been collected. We do not have any assets on deposit with Silicon
Valley Bank nor do we have any other financial relationship with
the bank or its affiliated entities.
- The Consolidated Appropriations Act of 2023 (“CAA”) was signed
into law in late December 2022 and expressly provides for separate
payment of non-opioid pain management drugs, like OMIDRIA, in the
outpatient surgery setting until January 1, 2028.
- We are preparing to resubmit our Biologics License Application
(“BLA”) for narsoplimab in hematopoietic stem cell
transplant-associated thrombotic microangiopathy (“TA-TMA”) and
have requested a meeting with FDA, expected to be held next
quarter, to confirm the additional information required by FDA to
support approval.
- We have initiated two clinical trials evaluating OMS906, one
enrolling patients with paroxysmal nocturnal hemoglobinuria (“PNH”)
who are treatment-naïve and the other enrolling PNH patients who
have demonstrated an unsatisfactory response to ravulizumab; dosing
is ongoing in the first and initiating in the second.
“With over $400 million available for operations and having
secured our ongoing OMIDRIA royalty stream, Omeros now has the
flexibility to retire our 2023 debt obligation while funding
accelerated advancement across our portfolio of cutting-edge
platforms and programs well into 2025. Any additional revenue
source – for which there are multiple opportunities – would only
extend that runway, further driving shareholder value without the
need for dilution,” said Gregory A. Demopulos, M.D., Omeros’
chairman and chief executive officer. “For narsoplimab, we are
meeting with FDA to confirm the information required for approval
of our resubmitted BLA for TA-TMA, we remain on track for
third-quarter release of topline data from our pivotal ARTEMIS-IGAN
trial, and there is mutual interest in working with the U.S.
government in COVID-19 and ARDS. Our long-acting MASP-2 inhibitor
OMS1029 looks promising in the clinic for quarterly IV or SC
administration and, together with our orally available
small-molecule inhibitors, complements narsoplimab and expands our
control over the lectin pathway. OMS906, targeting the key
activator of the alternative pathway MASP-3, we expect can also be
dosed once quarterly and, given its significant biological
advantages over potential competitors, pending efficacy data in PNH
followed by C3G will go a long way in answering whether MASP-3 and
OMS906 are the premier alternative-pathway target and therapeutic.
We also are hoping for good news over the coming weeks on our PDE7
inhibitor OMS527 in both addiction and in Parkinson’s disease. And
our novel molecular and cellular immuno-oncology platforms and
programs continue to generate exciting data that consistently point
to the same conclusion – the potential for transformative cancer
therapies. All of our portfolio programs could well be successful,
but the success of any one of them would deliver substantial
shareholder value.”
Fourth 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 and immunoglobulin A (“IgA”) nephropathy,
include:
- Preparations are underway for anticipated resubmission of our
BLA for narsoplimab in TA-TMA following the late-2022 receipt of
the decision by FDA’s Office of New Drugs regarding our appeal of
FDA’s complete response letter previously issued on our original
BLA. The decision denying our appeal proposed, as a path forward
for BLA resubmission, the inclusion of additional analyses
comparing response and survival in our completed pivotal trial to
appropriate historical controls. We have requested a meeting with
FDA’s Division of Nonmalignant Hematology to confirm the
information required by FDA to support approval of narsoplimab in
this indication. We expect that the Type B meeting will occur in
the first half of the second quarter of 2023.
- Our Phase 3 ARTEMIS-IGAN trial evaluating narsoplimab for the
treatment of IgA nephropathy continues to progress toward an
anticipated readout of 9-month data on the proteinuria endpoint in
the third quarter of 2023.
- An international group of leading transplanters recently
published a systematic review of signs and symptoms of TA-TMA in
Transplantation and Cellular Therapy, and a second manuscript on
TA-TMA diagnosis and treatment has been accepted for publication by
Bone Marrow Transplantation.
- Recent developments regarding OMS1029, our long-acting,
next-generation MASP-2 inhibitor, include:
- Dosing of all cohorts in a single-ascending dose Phase 1
clinical trial of OMS1029 was successfully completed in early 2023.
OMS1029 was well tolerated with no safety concerns identified.
Preliminary pharmacokinetic (“PK”) and pharmacodynamic (“PD”) data
show dose-proportional exposure and sustained lectin pathway
inhibition, consistent with potentially quarterly intravenous or
subcutaneous dosing.
- Preparations are underway to initiate, in summer 2023, a Phase
1 multiple-ascending-dose study of OMS1029 in healthy
subjects.
- Recent developments regarding OMS906, our lead monoclonal
antibody targeting mannan-binding lectin-associated serine
protease-3 (“MASP-3”), the key activator of the alternative
pathway, include:
- Clinical data from our single-ascending-dose Phase 1 study
evaluating both intravenous and subcutaneous administration of
OMS906 in healthy subjects were presented in December at the annual
meeting of the American Society of Hematology. As previously
announced, the drug was well tolerated, and there were no safety
signals of concern. Based on clinical data to date, we expect that
OMS906 will be dosed quarterly, either intravenously or
subcutaneously.
- In late 2022 we began enrolling in our Phase 1b clinical trial
evaluating OMS906 in treatment-naïve patients with PNH. Dosing in
this study began in early 2023.
- Enrollment has also begun in our Phase 1b clinical trial
evaluating OMS906 in PNH patients who have had an unsatisfactory
response to the C5 inhibitor ravulizumab. The study enrolls PNH
patients receiving ravulizumab, adds OMS906 to provide combination
therapy with ravulizumab for 24 weeks, and then provides OMS906
monotherapy in patients who demonstrate a hemoglobin response with
combination therapy. First dosing of OMS906 in this study is
scheduled to begin later this month, once the ravulizumab
monotherapy period has ended.
- A Phase 1b clinical trial evaluating OMS906 in patients with
complement 3 glomerulopathy (“C3G”) has also been initiated, with
enrollment expected to commence next month.
- Recent developments regarding OMS527, our phosphodiesterase 7
(“PDE7”) inhibitor program focused on addiction and movement
disorders, include:
- We are engaged in discussions with third parties regarding
external funding for development of our PDE7 inhibitors as a
treatment for addictive disorders.
- OMS527 is also being evaluated as a potential treatment for
levodopa-induced dyskinesias (“LID”), which are crippling,
involuntary movements reportedly affecting 50 percent or more of
levodopa-treated patients with Parkinson’s disease. LID is caused
by prolonged treatment with levodopa, the most prescribed treatment
for Parkinson’s. Collaborators at Emory University are evaluating
our PDE7 inhibitor in a clinically predictive primate model of
LID.
Financial Results
Net income for the fourth quarter of 2022 was $128.7 million, or
$2.05 per share, which includes the $200.0 million milestone
recognized as income in discontinued operations. This compares to a
net loss of $17.5 million in the third quarter of 2022, or $0.28
per share. Net loss from continuing operations for the fourth
quarter of 2022 was $46.0 million, or $0.73 cents per share. For
the third quarter of 2022, net loss from continuing operations was
$54.8 million, or $0.87 per share. Cash burn for the fourth quarter
of 2022 was $26.0 million.
Net income for the full year 2022 was $47.4 million, or $0.76
per share, and our net loss from continuing operations was $182.0
million or $2.90 per share. This compares to the prior full year’s
net income of $194.2 million, or $3.12 per share, and a loss from
continuing operations of $191.5, or $3.07 per share.
In December 2022, the milestone event entitling us to a $200.0
million milestone payment from Rayner occurred. We recorded the
$200.0 million milestone as revenue in discontinued operations and
as a receivable in December 2022. We received the cash payment on
February 3, 2023. Per the terms of the asset purchase agreement
with Rayner, following the milestone event the applicable royalty
rate was reduced to 30% of the net revenue from U.S. sales of
OMIDRIA. Upon achieving the $200.0 million milestone, we
conservatively revalued the OMIDRIA contract royalty asset using
the reduced royalty rate of 30% on future OMIDRIA U.S. net sales
while reflecting an increase in expected OMIDRIA U.S. net sales due
to the CAA securing separate payment for drugs like OMIDRIA until
at least January 1, 2028. This remeasurement resulted in a $26.2
million reduction in the OMIDRIA contract royalty asset and a
corresponding loss being recorded in discontinued operations in the
fourth quarter.
During the fourth quarter of 2022, we earned royalties of $17.9
million on $35.8 million of Rayner sales of OMIDRIA. This compares
to earned royalties of $16.5 million in the third quarter of 2022.
These royalties were recorded as a reduction of the OMIDRIA
contract royalty asset.
Total costs and expenses for the fourth quarter of 2022 were
$40.1 million compared to $50.8 million for the third quarter of
2022. The decrease was primarily due to the manufacturing of
narsoplimab drug substance in the third quarter of 2022 for future
commercial and clinical use. We expense commercial drug substance
until approval is assured.
Interest expense during the fourth quarter of 2022 was $7.9
million, an increase of $3.0 million from the third quarter of
2022. On September 30, 2022, we sold to DRI Healthcare Acquisitions
LP an interest in a portion of our future OMIDRIA royalty
receivables and received $125.0 million in cash proceeds. The
transaction was recorded as debt for financial reporting purposes
with an implied interest rate of 9.4%.
Net income from discontinued operations, net of tax was $174.8
million, or $2.78 per share, in the fourth quarter of 2022 compared
to net income from discontinued operations, net of tax of $37.3
million, or $0.59 per share, in the prior quarter. The increase was
primarily due to the $200.0 milestone we earned in the fourth
quarter, partially offset by the milestone-driven revaluation of
the OMIDRIA contract royalty asset.
As of December 31, 2022, we had $194.9 million of cash, cash
equivalents and short-term investments. In addition, we had $213.2
million in accounts receivable, all of which have now been
collected. We previously maintained a line of credit with Silicon
Valley Bank, which we allowed to expire in August 2022. We do not
have any assets on deposit with Silicon Valley Bank nor do we have
any other financial relationship with the bank or its affiliated
entities
Conference Call Details
To access the live conference call via phone, participants must
register to receive a unique PIN at the following URL:
https://register.vevent.com/register/BIb42f849906d44aaea742e6f375a5609e.
Once registered, you will have two options: (1) Dial in to the
conference line provided at the registration site using the PIN
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receive a new PIN.
For online access to the live or subsequently archived webcast
of the conference call, go to the investor page of 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
anticipated next steps in relation to the biologics license
application for narsoplimab, 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 of
OMIDRIA, 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 13, 2023. 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 AND COMPREHENSIVE INCOME (LOSS)
(In thousands, except share
and per share data)
Three Months Ended
Year Ended
December 31,
December 31,
2022
2021
2022
2021
Costs and expenses:
Research and development
$
26,550
$
30,327
$
112,721
$
118,775
Selling, general and administrative
13,589
12,560
50,668
54,842
Total costs and expenses
40,139
42,887
163,389
173,617
Loss from continuing operations
(40,139
)
(42,887
)
(163,389
)
(173,617
)
Interest expense
(7,902
)
(4,949
)
(22,702
)
(19,669
)
Interest and other income
1,993
526
4,062
1,740
Net loss from continuing operations
(46,048
)
(47,310
)
(182,029
)
(191,546
)
Net income from discontinued operations,
net of tax (1)
174,781
327,930
229,446
385,781
Net income
$
128,733
$
280,620
$
47,417
$
194,235
Basic and diluted net income (loss) per
share:
Net loss from continuing operations
$
(0.73
)
$
(0.76
)
$
(2.90
)
$
(3.07
)
Net income from discontinued operations
(1)
2.78
5.24
3.66
6.19
Net income
$
2.05
$
4.48
$
0.76
$
3.12
Weighted-average shares used to compute
basic and diluted net income (loss) per share
62,762,932
62,552,395
62,737,091
62,344,100
(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 months and year ended
December 31, 2021 in our financial statements.
OMEROS CORPORATION
UNAUDITED CONSOLIDATED BALANCE
SHEET
(In thousands)
December 31,
December 31,
2022
2021
Assets
Current assets:
Cash and cash equivalents
$
11,009
$
100,808
Short-term investments
183,909
56,458
OMIDRIA contract royalty asset,
short-term
28,797
44,319
Receivables, net
213,221
38,155
Prepaid expense and other assets
6,300
8,216
Total current assets
443,236
247,956
OMIDRIA contract royalty asset
123,425
140,251
Right of use assets
21,762
28,276
Property and equipment, net
1,492
1,731
Restricted investments
1,054
1,054
Total assets
$
590,969
$
419,268
Liabilities and shareholders’
equity
Current liabilities:
Accounts payable
$
5,989
$
13,400
Accrued expenses
30,551
33,134
Current portion of unsecured convertible
senior notes, net
94,381
—
Current portion of OMIDRIA royalty
obligation
1,152
—
Current portion of lease liabilities
4,310
5,255
Total current liabilities
136,683
51,789
Unsecured convertible senior notes,
net
220,906
313,458
OMIDRIA royalty obligation
125,126
—
Lease liabilities, non-current
22,426
29,126
Other accrued liabilities - noncurrent
444
1,115
Shareholders’ equity:
Common stock and additional paid-in
capital
721,401
706,914
Accumulated deficit
(635,717
)
(683,134
)
Total shareholders’ equity
85,684
23,780
Total liabilities and shareholders’
equity
$
590,969
$
419,268
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
(65,439
)
Interest on OMIDRIA contract royalty
asset
18,634
Remeasurement adjustments
14,457
OMIDRIA contract royalty asset at December
31, 2022
$
152,222
Net income from discontinued operations is
as follows:
Three Months Ended
Year Ended
December 31,
December 31,
2022
2021
2022
2021
(In thousands)
Product sales, net
$
—
$
30,845
$
—
$
110,735
Costs and expenses
—
8,592
—
30,631
Gross margin
—
22,253
—
80,104
Gain on sale of OMIDRIA
—
305,648
—
305,648
Milestone payment
200,000
—
200,000
—
Interest on OMIDRIA contract royalty
asset
4,895
—
18,634
—
Remeasurement adjustments
(26,174
)
—
14,457
—
Other income, net
12
1,035
307
1,035
Income before income tax
178,733
328,936
233,398
386,787
Income tax expense
(3,952
)
(1,006
)
(3,952
)
(1,006
)
Net income from discontinued operations,
net of tax
$
174,781
$
327,930
$
229,446
$
385,781
View source
version on businesswire.com: https://www.businesswire.com/news/home/20230313005766/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
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