– 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 second quarter ended June 30,
2022, which include:
- For the quarter ended June 30, 2022, Omeros earned royalties of
$17.2 million on net sales of the company’s former ophthalmology
product OMIDRIA®. Royalties earned in the quarter represent 50
percent of net sales of OMIDRIA by Rayner Surgical, Inc. (Rayner),
which purchased Omeros’ ophthalmology assets in December 2021.
Rayner’s reported net sales of $34.5 million for the second quarter
of 2022, all of which were in the U.S., establish a new all-time
high for quarterly OMIDRIA sales and represent a $5.7 million
increase over net sales of $28.8 million reported by Omeros for the
second quarter of last year.
- Net loss in 2Q 2022 was $30.9 million, or $0.49 per share,
which included $3.7 million of non-cash expenses, or $0.06 per
share. This compares to a net loss of $28.6 million, or $0.46 per
share for the prior year quarter, which included $3.9 million of
non-cash expenses, or $0.06 per share.
- At June 30, 2022, Omeros had $122.6 million of cash, cash
equivalents and short-term investments available for operations,
which is a reduction of $19.7 million from March 31, 2022. In
addition, Omeros had $14.5 million in net receivables available for
operations at June 30, 2022.
- In June 2022, Omeros submitted to the United States Food and
Drug Administration (FDA) a request for Formal Dispute Resolution
regarding 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). 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 (OND). Last month, in
accordance with the standard dispute resolution procedure, Omeros
had a formal meeting with the OND official assigned to decide the
dispute. A decision is expected in August 2022.
“We remain confident that approval of narsoplimab in TA-TMA is
warranted, and we look forward to OND’s decision later this month,”
said Gregory A. Demopulos, M.D., Omeros’ chairman and chief
executive officer. “In addition to FDA’s decision on narsoplimab
approval, a series of value-driving milestones have aligned over
the next few quarters: data from our Phase 3 trial of narsoplimab
in IgA nephropathy are on track for readout by mid-next year; our
MASP-3 inhibitor OMS906 is starting trials in PNH and C3
glomerulopathy with efficacy data targeted by early next year;
about that same time, we expect data from our Phase 1 trial of
OMS1029, our long-acting MASP-2 inhibitor, which began dosing
earlier this week; also in early 2023, our PDE7 inhibitor OMS527
should have data available in a clinically predictive primate model
of levodopa-induced dyskinesias; and, with separate payment for
OMIDRIA reconfirmed by CMS in its recently released proposed rule
for the Outpatient Prospective Payment System, we expect continuing
growth in our royalty stream and, should OMIDRIA obtain long-term
reimbursement, to secure the $200-million milestone payment.”
Second Quarter and Recent Clinical 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:
- Enrollment in Omeros’ Phase 3 ARTEMIS-IGAN trial continues to
progress toward an anticipated readout of 9-month data on
proteinuria by mid-next year.
- The Omeros teams in Cambridge, UK and Seattle recently
published two manuscripts detailing the company’s latest
COVID-19-related discoveries, the first by Ali et al. in Frontiers
in Immunology and the second by Lynch et al. in Clinical and
Translational Medicine. Together, these publications describe the
findings that:
- Patients with severe COVID-19 early in disease show marked
complement consumption driven by lectin pathway hyperactivation,
causing secondary hypocomplementemia and loss of
complement-mediated immune protection against microbial infection.
This hypocomplementemia increases the risk of clinically severe
infections, a common cause of morbidity and death in COVID-19.
- Narsoplimab restores complement function and bactericidal
activity, preventing risk of secondary infection.
- 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 (QLHC). Omeros
looks forward to QLHC’s disclosure of the narsoplimab results.
Recent developments regarding OMS906, Omeros’ 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:
- In July, OMS906 received designation from FDA as an orphan drug
for the treatment of paroxysmal nocturnal hemoglobinuria (PNH).
Orphan-drug designation is granted by FDA to encourage development
of a drug that targets a condition affecting fewer than 200,000
U.S. patients annually. The benefits of orphan drug designation
include seven years of market exclusivity following marketing
approval, tax credits on U.S. clinical trials, eligibility for
orphan drug grants, and waiver of certain administrative fees.
- To accelerate obtaining OMS906 efficacy data, in addition to
the Phase 1b trial expected to begin enrolling soon and evaluating
OMS906 in patients with PNH who have had an unsatisfactory response
to the C5 inhibitor ravulizumab, Omeros is expanding its program of
OMS906 clinical trials to include treatment-naïve PNH patients and
complement 3 (C3) glomerulopathy patients as well as one or more
related indications. Efficacy data in these indications are
targeted by early 2023.
- Omeros has submitted an abstract describing the results of the
OMS906 Phase 1 study for presentation at a major medical congress
later this year. Preliminary results from the Phase 1 study were
previously reported and no safety signals of concern were
noted.
- A Phase 1 clinical trial assessing safety, tolerability and
pharmacokinetics/pharmacodynamics (PK/PD) of OMS1029 in healthy
subjects is underway, with the first dose administered earlier this
week. Designed for convenient dosing, OMS1029 is expected to enable
Omeros to pursue a range of indications complementary to those for
narsoplimab. Based on animal PK/PD data to date, dosing in humans
is expected to be once-monthly to once-quarterly by subcutaneous or
intravenous administration.
Financial Results
On December 23, 2021, Rayner acquired OMIDRIA and certain
related assets and liabilities. The completion of the sale required
Omeros to reclassify all revenues and expenses related to OMIDRIA
as discontinued operations for fiscal year 2021 in its financial
statements.
During the second quarter of 2022, Omeros earned royalties of
$17.2 million on sales of OMIDRIA, which were recorded as a
reduction from the OMIDRIA contract royalty asset. The company also
recorded $10.1 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 second quarter of 2022 were
$37.4 million compared to $45.6 million for the second quarter of
2021. The decrease was primarily due to the timing of narsoplimab
manufacturing activities and a reduction in U.S. TA-TMA pre-launch
activities.
Net loss was $30.9 million in the second quarter of 2022, or
$0.49 per share, which included $3.7 million of non-cash expenses,
or $0.06 per share. This compares to a net loss of $28.6 million,
or $0.46 per share, including $3.9 million of non-cash expenses, or
$0.06 per share, in 2Q 2021.
As of June 30, 2022, the company had $122.2 million of cash,
cash equivalents and short-term investments with an additional
$14.5 million in receivables, net.
Conference Call Details
To access the live conference call via phone, please dial (833)
634-2592 from the United States and Canada or (412) 902-4100
internationally and ask to be placed into the Omeros earnings call.
Please dial in approximately 10 minutes prior to the start of the
call. A telephone replay will be available for one week following
the call and may be accessed by dialing (877) 344-7529 from the
United States, (412) 317-0088 internationally, and (855) 669-9658
from Canada. The replay access code is 4990130.
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.
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 expectations with
regard to Omeros’ pursuit of regulatory approval for narsoplimab in
TA-TMA, including expectations regarding the potential or
anticipated outcomes of its formal dispute resolution request, and
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, 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
Six Months Ended
June 30,
June 30,
2022
2021
2022
2021
Costs and expenses:
Research and development
$
23,516
$
30,126
$
47,603
$
62,630
Selling, general and administrative
13,922
15,484
24,881
28,270
Total costs and expenses
37,438
45,610
72,484
90,900
Loss from continuing operations
(37,438
)
(45,610
)
(72,484
)
(90,900
)
Interest expense
(4,927
)
(4,910
)
(9,868
)
(9,807
)
Other income
670
333
1,163
751
Net loss from continuing operations
(41,695
)
(50,187
)
(81,189
)
(99,956
)
Net income from discontinued
operations
10,846
21,594
17,329
36,273
Net loss
$
(30,849
)
$
(28,593
)
$
(63,860
)
$
(63,683
)
Basic and diluted net income (loss) per
share
Net loss from continuing operations
(0.66
)
(0.80
)
$
(1.30
)
$
(1.61
)
Net income from discontinued
operations
0.17
0.34
0.28
0.59
Net loss
$
(0.49
)
$
(0.46
)
$
(1.02
)
$
(1.02
)
Weighted-average shares used to compute
basic and diluted net income (loss) per share
62,730,015
62,373,521
62,727,395
62,154,714
(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 six months ended June 30,
2021 in our financial statements.
OMEROS CORPORATION
UNAUDITED CONSOLIDATED BALANCE
SHEET DATA
(In thousands)
June 30,
December 31,
2022
2021
Cash and cash equivalents
$
122,562
$
157,266
OMIDRIA contract royalty asset
170,606
184,570
Total assets
345,638
419,268
Total current liabilities
38,501
51,789
Lease liabilities
28,665
34,381
Unsecured convertible senior notes,
net
314,358
313,458
Total shareholders’ equity (deficit)
(32,702
)
23,780
Working capital
154,221
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
(31,062
)
Royalty interest income and remeasurement
adjustments
17,098
OMIDRIA contract royalty asset at June 30,
2022
$
170,606
Net income from discontinued operations is
as follows:
Three Months Ended
Six Months Ended
June 30,
June 30,
2022
2021
2022
2021
(In thousands)
Product sales, net
$
—
$
28,823
$
—
$
49,884
Royalty interest income and remeasurement
adjustments
10,102
—
17,098
—
Total
10,102
28,823
17,098
49,884
Other income, costs and expenses, net
(744
)
7,229
(231
)
13,611
Net income from discontinued
operations
$
10,846
$
21,594
$
17,329
$
36,273
View source
version on businesswire.com: https://www.businesswire.com/news/home/20220809006009/en/
Jennifer Cook Williams Cook Williams Communications, Inc.
Investor and Media Relations IR@omeros.com
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