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SEATTLE--(BUSINESS WIRE)--Nov 9, 2022--
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:
“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
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: https://register.vevent.com/register/BI4363ad5bbf154eef81c3be16f4e47738. 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.
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/
CONTACT: Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations
IR@omeros.com
KEYWORD: WASHINGTON UNITED STATES NORTH AMERICA
INDUSTRY KEYWORD: ONCOLOGY HEALTH INFECTIOUS DISEASES RESEARCH SCIENCE PHARMACEUTICAL BIOTECHNOLOGY
SOURCE: Omeros Corporation
Copyright Business Wire 2022.
PUB: 11/09/2022 04:02 PM/DISC: 11/09/2022 04:02 PM
http://www.businesswire.com/news/home/20221109006015/en