– 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, 2023, which include:
- Net loss for the fourth quarter of 2023 was $9.1 million, or
$0.15 per share, compared to a net loss of $37.8 million, or $0.60
per share for the third quarter of 2023. Net loss from continuing
operations was $39.3 million for the 2023 fourth quarter compared
to $51.7 million for the prior quarter.
- For the year ended December 31, 2023, net loss was $117.8
million, or $1.88 per share, compared to net income of $47.4
million, or $0.76 per share, in the prior year. The 2022 results
included recognition of a $200.0 million milestone that became
payable by Rayner Surgical, Inc. (“Rayner”) upon the achievement of
the milestone event in the fourth quarter of 2022. Net loss from
continuing operations for the year ended December 31, 2023 was
$174.9 million compared to a net loss from continuing operations of
$182.0 million in the prior year. Cash provided for operations for
the year ended December 31, 2023 was $74.7 million, which includes
receipt of the $200.0 million milestone payment in February
2023.
- In February 2024, Omeros and DRI Healthcare Acquisitions LP
(“DRI”) amended the OMIDRIA royalty purchase agreement to sell an
expanded royalty interest to DRI, resulting in Omeros receiving
$115.5 million in cash. After the amendment, DRI is entitled to
receive all royalties on U.S. net sales of OMIDRIA through December
31, 2031. Omeros will receive any and all royalties on ex-U.S.
sales and, from and after January 1, 2032, all royalties globally.
We also have the potential to receive two future milestones, each
for up to $27.5 million, depending on U.S. OMIDRIA revenues.
- At December 31, 2023, we had $171.8 million of cash and
short-term investments available for operations and debt servicing.
In addition, we received the $115.5 million from DRI in February
2024. Our cash used in operations for the fourth quarter was $34.8
million. We also used cash to retire the $95.0 million outstanding
on our 2023 convertible notes at maturity, $4.9 million to
repurchase $9.1 million par value of our 2026 convertible notes and
$4.7 million to repurchase 1.8 million shares of our common
stock.
- We continue to engage with FDA regarding the planned
resubmission of our Biologics License Application (“BLA”) for
narsoplimab in hematopoietic stem cell transplant-associated
thrombotic microangiopathy (“TA-TMA”). As previously disclosed, we
submitted to FDA in the fall of 2023 an analysis plan to assess
already existing clinical trial data, existing data from an
historical control population available from an external source,
data from the narsoplimab expanded access (i.e., compassionate use)
program, and data directed to the mechanism of action of
narsoplimab. We are having ongoing discussions with the agency
regarding the proposed analysis plan. As a result, we are currently
unable to estimate when we will submit the BLA or, subsequently,
FDA’s timing for a decision regarding approval.
- Both of our ongoing Phase 2 clinical trials evaluating OMS906
for the treatment of paroxysmal nocturnal hemoglobinuria (“PNH”)
are fully enrolled and each has recently reported positive data
from interim analyses. We have also initiated an extension study to
assess the long-term safety and tolerability of OMS906 in patients
with PNH that enrolls patients who have completed either of our two
Phase 2 studies without a break in OMS906 treatment. OMS906 is our
MASP-3 inhibitor antibody targeting the alternative pathway of
complement. Our Phase 3 development programs for OMS906 in PNH and
C3G are targeted to begin in late 2024 and early 2025,
respectively.
“We continue pursuing diligently four major corporate priorities
– those that we believe will drive substantial near-term
shareholder value,” said Gregory A. Demopulos, M.D., Omeros’
chairman and chief executive officer. “The first, extending our
cash runway non-dilutively into 2026, was successfully achieved
through the OMIDRIA partial royalty sale to DRI Healthcare earlier
this year, securing an upfront payment of $116 million and creating
the opportunity to earn an additional $55 million in OMIDRIA
sales-based milestones. In parallel, we reduced our outstanding
common share count by 8 percent through stock repurchases. With
high survival rates in our pivotal trial and in over 130 adult and
pediatric patients who accessed the narsoplimab compassionate use
program, together with the growing number of publications and
international congress presentations detailing narsoplimab’s
survival benefits in treatment-naïve TA-TMA patients as well as in
those who previously failed other complement inhibitor regimens, we
are continuing discussions with FDA to achieve our second corporate
priority – regulatory approval of narsoplimab in TA-TMA. Success on
our third and fourth corporate priorities – the initiation of
well-designed and de-risked OMS906 Phase 3 and OMS1029 Phase 2
programs – appears likely. Beyond these four priorities, the team
is working hard to unlock the value in our other clinical and
preclinical assets. We expect those committed efforts and focus to
continue driving shareholder value for our investors now and in the
months ahead.”
Fourth Quarter and Recent Clinical Developments
- Recent developments regarding narsoplimab, our lead monoclonal
antibody targeting mannan-binding lectin-associated serine
protease-2 (“MASP-2”), include the following:
- In February 2024, a report detailing treatment with narsoplimab
in nine adult patients with TA-TMA was featured as a poster
presentation at the 2024 Tandem Meetings – the Transplantation
& Cellular Therapy Meetings of the American Society for
Transplantation and Cellular Therapy and the Center for
International Blood and Marrow Transplant Research. The report was
authored by an external group of U.S. investigators involved in
treating these patients with narsoplimab provided under Omeros’
expanded access or compassionate use program. Six of the nine
patients receiving narsoplimab treatment demonstrated a durable and
complete response to narsoplimab.
- In March 2024, investigators at Memorial Sloan Kettering Cancer
Center published a report in Bone Marrow Transplantation
describing, for the first time, achievement of a complete response
to narsoplimab treatment while maintaining the use of calcineurin
inhibitors, or CNIs, and mTOR inhibitors in a high-risk TA-TMA
patient. CNIs and mTOR inhibitors are used to prevent
life-threatening graft-versus-host disease, or GvHD, in stem cell
transplant patients, however, they are also known to potentiate
TA-TMA. Withdrawal of these agents has historically been considered
the first step in managing TA-TMA, however this presents greater
risk of GvHD-related mortality. The ability to successfully treat
TA-TMA with narsoplimab without withdrawing these GvHD-preventing
agents would represent a further significant advance of the drug in
the management of TA-TMA.
- A panel of international experts is preparing to author an
additional publication, detailing the survival benefits of
narsoplimab in over 130 TA-TMA patients under our expanded access
program.
- Recent developments regarding OMS1029, our long-acting,
next-generation MASP-2 inhibitor, include:
- Dosing has been completed in the second of two planned cohorts
of our ongoing Phase 1 multiple-ascending-dose study of OMS1029 in
healthy volunteers. A single-ascending-dose Phase 1 clinical trial
was completed in early 2023 and showed that OMS1029 was
well-tolerated with no safety concerns identified. We expect the
multiple-ascending dose study to conclude in mid-2024. We continue
to evaluate several large market indications for Phase 2 of
clinical development of OMS1029 and expect to select an indication
for Phase 2 development in the third quarter of 2024.
- 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:
- Our ongoing Phase 2 clinical trial evaluating OMS906 in PNH
patients who have had an unsatisfactory response to the C5
inhibitor ravulizumab is fully enrolled with 13 patients. Results
from a pre-specified interim analysis of showed that OMS906
administered in combination with ravulizumab resulted in rapid
improvement in hemoglobin levels and absolute reticulocyte count.
The study has a “switch-over” design and 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. The interim analysis data from the combination therapy
portion of the trial showed statistically significant and
clinically meaningful improvements in both mean hemoglobin levels
and absolute reticulocyte counts by week 4 of combination therapy,
with a sustained response demonstrated through week 24 (the latest
assessment prior to the interim analysis cutoff). The interim
analysis data demonstrate that in patients experiencing substantial
extravascular hemolysis while on ravulizumab monotherapy the
addition of OMS906 was well tolerated with no safety signals of
concern. Further, the rapid improvement in hemoglobin and the
reduction in absolute reticulocyte count following OMS906 therapy
demonstrate that OMS906 prevents extravascular hemolysis. Full
details from the interim analysis are expected to be presented at a
major hematology conference in mid-2024. Interim analysis data from
the monotherapy portion of the trial are expected to be available
in late 2024.
- Our Phase 2 clinical trial evaluating OMS906 in PNH patients
who have not previously been treated with a complement inhibitor is
also fully enrolled with 11 patients. In December 2023, new and
updated interim analysis data from this trial were featured as an
oral presentation at the annual congress of the American Society of
Hematology, or ASH. The presentation described the clinically
meaningful and statistically significant effects of OMS906 observed
across all measured markers of hemolysis, including hemoglobin,
lactate dehydrogenase (“LDH”), and red blood cell clone size in PNH
patients. This latest analysis reported that all enrolled patients
achieved increases in hemoglobin of at least 2 grams per deciliter.
Additionally, all 9 patients who did not have myelodysplastic
syndrome, a condition causing bone marrow failure, achieved an
absolute hemoglobin greater than 12 grams per deciliter. No
patients were reported to have had a clinical breakthrough of PNH
or a thrombotic event, and none were reported to require a
transfusion while receiving OMS906 treatment.
- Two abstracts have been submitted and are expected to be
presented at a major hematology conference in mid-2024. The first
is directed to clinical pharmacology of OMS906 and elucidates the
effect of OMS906 on MASP-3 and resultant blockade on alternative
pathway activity. The second describes population PK/PD models that
predict exposure-response relationships for OMS906 versus mature
factor D, hemoglobin and LDH.
- We have initiated an extension study to assess the long-term
safety and tolerability of OMS906 in patients with PNH. Enrolled
patients who have completed one of our two PNH Phase 2 studies
evaluating OMS906 will move directly into the extension study
without interruption of treatment. Data from this study will
support a planned BLA for OMS906 in PNH.
- In February, we met with FDA to discuss our development program
for OMS906 in PNH. We presented clinical and nonclinical data and
requested input on expectations for Phase 3 studies and BLA
submission. FDA confirmed that the scope of our nonclinical program
is sufficient to support Phase 3 studies and provided input on
dosing and design of the proposed Phase 3 studies to support a BLA
in PNH. We expect to meet again with FDA later this year to discuss
further details of the design of our Phase 3 studies. We are
targeting to initiate our Phase 3 development program evaluating
OMS906 for treatment of PNH in late 2024.
- Our Phase 2 clinical program evaluating OMS906 in patients with
complement 3 glomerulopathy (“C3G”) is also underway. Although
delayed by a protocol amendment to change the OMS906 dose based on
information learned from our PNH programs, multiple clinical sites
now are open and patients are being screened for enrollment.
- Recent developments regarding OMS527, our phosphodiesterase 7
(“PDE7”) inhibitor program focused on addictions and compulsive
disorders as well as movement disorders, include:
- Funded by a three-year, $6.69 million grant awarded by the
National Institute on Drug Abuse (“NIDA”) in April 2023 we continue
to pursue development of our lead orally administered PDE7
inhibitor compound for the treatment of cocaine use disorder
(“CUD”). The grant is intended to support a preclinical cocaine
interaction study, which we expect to complete by the end of 2024,
as well as a randomized, placebo-controlled, inpatient clinical
study evaluating the safety and effectiveness of OMS527 in patients
with CUD. Previously, a Phase 1 clinical trial of the study drug in
healthy subjects was successfully completed.
- Together with collaborators at Emory University, we continue to
evaluate the potential of our PDE7 inhibitors to treat
levodopa-induced dyskinesias (“LID”). LID is caused by prolonged
treatment with levodopa (“L-DOPA”), the most prescribed treatment
for the over 10 million patients with Parkinson’s disease
worldwide. LID is reported to affect approximately 50 percent of
Parkinson's patients who have been treated for five or more years
with L-DOPA. The only approved treatment for LID is marginally
effective and fraught with safety issues.
Financial Results
Net loss for the fourth quarter of 2023 was $9.1 million, or
$0.15 per share, compared to a net loss in the prior quarter of
$37.8 million, or $0.60 per share. Net loss from continuing
operations was $39.3 million in the current quarter compared to a
net loss of $51.7 million in the prior quarter. The current quarter
net loss from continuing operations included a $4.1 million gain on
the early extinguishment of $9.1 million par value of our 2026
convertible notes.
For the full year ended December 31, 2023, our net loss was
$117.8 million, or $1.88 per share, compared to net income of $47.4
million, or $0.76 per share, in the prior year period. The primary
difference between the periods was the achievement of the $200.0
million OMIDRIA milestone event in the fourth quarter of 2022,
which is reported as a component of discontinued operations.
Net loss from continuing operations for the full year ended
December 31, 2023, was $174.9 million compared to a loss of $182.0
million in the prior year.
Cash provided for operations for the year ended December 31,
2023 was $74.7 million, which includes receipt of the $200.0
million milestone payment in February 2023. This compares to cash
used in operations of $86.5 million for the prior year.
For the fourth quarter of 2023, we earned OMIDRIA royalties of
$10.7 million on Rayner’s U.S. net sales of $35.7 million. This
compares to earned OMIDRIA royalties of $10.0 million during the
third quarter on U.S. net sales of $33.3 million.
For the year ended December 31, 2023, we earned OMIDRIA
royalties of $40.6 million on Rayner’s U.S. net sales of $135.3
million. This compares to earned OMIDRIA royalties of $65.4 million
on U.S. net sales of $130.9 million during the year ended December
31, 2022. The difference in earned royalties reflects the decrease
from 50 percent to 30 percent in the base royalty rate applicable
to U.S. net sales of OMIDRIA, which occurred in December 2022 upon
achievement of the $200.0 million milestone event.
In February 2024, Omeros and DRI entered into an amended and
restated royalty purchase agreement under which Omeros sold to DRI
an expanded interest in royalties payable by Rayner based on U.S.
net sales of OMIDRIA. Omeros received $115.5 million in cash for
the expanded royalty interest and is also eligible to receive two
future milestone payments, each up to $27.5 million, based on
achievement of certain thresholds for U.S. net sales of OMIDRIA.
The amendment eliminated the annual caps on payments to which DRI's
purchased royalty interest was previously subject and provides that
DRI will now receive all royalties on U.S. net sales of OMIDRIA
payable between January 1, 2024 and December 31, 2031. Omeros
retains the right to receive all royalties on any net sales of
OMIDRIA outside the U.S. and, after December 31, 2031, to all
royalties on OMIDRIA net sales globally.
Total operating expenses for the fourth quarter of 2023 were
$39.8 million compared to $48.2 million for the third quarter of
2023. The decrease was primarily due to the timing of employee
compensation costs and payment of a development milestone under a
technology license in the third quarter of 2023.
Interest expense during the fourth quarter of 2023 was $7.1
million compared to $7.9 million during the prior quarter. The
decrease was primarily due to retiring $95.0 million of our 2023
convertible notes upon maturity in November 2023.
During the fourth quarter of 2023, we earned $3.4 million in
interest and other income compared to $4.4 million in the third
quarter. The decrease was due to lower average balances available
to invest due to the retirement of the 2023 convertible notes.
Net income from discontinued operations, net of tax, was $30.2
million, or $0.48 per share, in the fourth quarter of 2023 compared
to $13.9 million, or $0.22 per share, in the third quarter of 2023.
The difference was primarily attributable to a $16.1 million
increase in remeasurement adjustments on the OMIDRIA contract
royalty asset in the current quarter.
At December 31, 2023, we had $171.8 million of cash and
short-term investments available for operations and debt service.
In addition, we received the $115.5 million from DRI in February
2024. Our cash used in operations for the fourth quarter was $34.8
million. We also used cash to retire the $95.0 million outstanding
on our 2023 convertible notes at maturity, $4.9 million to
repurchase $9.1 million par value of our 2026 convertible notes and
$4.7 million to repurchase 1.8 million shares of our common
stock.
We expect our first quarter net loss to be $34.0 to $37.0
million or $0.58 to $0.63 loss per share. As of March 31, 2024, we
expect our cash and investments balance available for operations
and debt service to be approximately $230.0 million after
repurchasing 3.2 million shares of our outstanding common stock for
$11.9 million during the first quarter. Our total common stock
outstanding at March 31, 2024 is 57,942,695.
Conference Call Details
Omeros’ management will host a conference call and webcast 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.
For online access to the live webcast of the conference call, go
to Omeros’ website at
https://investor.omeros.com/upcoming-events.
To access the live conference call via phone, participants must
register at this link to receive a unique PIN. Once registered, you
will have two options: (1) Dial in to the conference line provided
at the registration site using the PIN provided to you, or (2)
choose the “Call Me” option, which will instantly dial the phone
number you provide. Should you lose your PIN or registration
confirmation email, simply re-register to receive a new PIN.
A replay of the call will be made accessible online at
https://investor.omeros.com/archived-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. Omeros’
long-acting MASP-2 inhibitor OMS1029 is currently in a Phase 1
multi-ascending-dose 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 and complement 3 glomerulopathy. Funded by the
National Institute on Drug Abuse, Omeros’ lead phosphodiesterase 7
inhibitor OMS527 is in clinical development for the treatment of
cocaine use disorder and, in addition, is being developed as a
therapeutic for other addictions as well as for a major
complication of treatment for movement disorders. Omeros also is
advancing a broad portfolio of novel immuno-oncology programs
comprised of two cellular and three molecular platforms. 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
the anticipated next steps in relation to the biologics license
application for narsoplimab, the timing of regulatory events, the
availability of clinical trial data, the prospects for obtaining
FDA approval of narsoplimab in any indication, expectations
regarding the initiation or continuation of clinical trials
evaluating Omeros’ drug candidates and the anticipated availability
of data therefrom, and expectations regarding the sufficiency of
our capital resources to fund operations, 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, our 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 our
Annual Report on Form 10-K filed with the Securities and Exchange
Commission on April 1, 2024. Given these risks, uncertainties and
other factors, you should not place undue reliance on these
forward-looking statements, and we assume 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,
2023
2022
2023
2022
Costs and expenses:
Research and development
$
28,890
$
26,550
$
114,870
$
112,721
Selling, general and administrative
10,875
13,589
49,660
50,668
Total costs and expenses
39,765
40,139
164,530
163,389
Loss from operations
(39,765
)
(40,139
)
(164,530
)
(163,389
)
Interest expense
(7,063
)
(7,902
)
(30,844
)
(22,702
)
Interest and other income
3,429
1,993
16,342
4,062
Gain on early extinguishment of
convertible senior notes
4,112
—
4,112
—
Net loss from continuing operations
(39,287
)
(46,048
)
(174,920
)
(182,029
)
Net income from discontinued operations,
net of tax
30,219
174,781
57,107
229,446
Net income (loss)
$
(9,068
)
$
128,733
$
(117,813
)
$
47,417
Basic and diluted net income (loss) per
share:
Net loss from continuing operations
$
(0.63
)
$
(0.73
)
$
(2.79
)
$
(2.90
)
Net income from discontinued
operations
0.48
2.78
0.91
3.66
Net income (loss)
$
(0.15
)
$
2.05
$
(1.88
)
$
0.76
Weighted-average shares used to compute
basic and diluted net income (loss) per share
62,440,772
62,762,932
62,739,227
62,737,091
OMEROS CORPORATION
UNAUDITED CONSOLIDATED BALANCE
SHEET
(In thousands)
December 31,
December 31,
2023
2022
Assets
Current assets:
Cash and cash equivalents
$
7,105
$
11,009
Short-term investments
164,743
183,909
OMIDRIA contract royalty asset,
short-term
29,373
28,797
Receivables
8,096
213,221
Prepaid expense and other assets
8,581
6,300
Total current assets
217,898
443,236
OMIDRIA contract royalty asset
138,736
123,425
Right of use assets
18,631
21,762
Property and equipment, net
1,950
1,492
Restricted investments
1,054
1,054
Total assets
$
378,269
$
590,969
Liabilities and shareholders’ equity
(deficit)
Current liabilities:
Accounts payable
$
7,712
$
5,989
Accrued expenses
31,868
30,551
Current portion of convertible senior
notes, net
—
94,381
Current portion of OMIDRIA royalty
obligation
8,576
1,152
Current portion of lease liabilities
5,160
4,310
Total current liabilities
53,316
136,383
Convertible senior notes, net
213,155
220,906
OMIDRIA royalty obligation
116,550
125,126
Lease liabilities, non-current
18,143
22,426
Other accrued liabilities, non-current
2,088
444
Shareholders’ equity (deficit):
Common stock and additional paid-in
capital
728,547
721,401
Accumulated deficit
(753,530
)
(635,717
)
Total shareholders’ equity (deficit)
(24,983
)
85,684
Total liabilities and shareholders’
equity (deficit)
$
378,269
$
590,969
View source
version on businesswire.com: https://www.businesswire.com/news/home/20240401079125/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
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