SEATTLE / Aug 09, 2023 / Business Wire / 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 second quarter ended June 30, 2023, which include:
“Our team continued building significant shareholder value throughout the second quarter of 2023,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. “Working with FDA, we continue to make progress toward a resubmission of our narsoplimab BLA for TA-TMA and are targeting a mid-2024 FDA decision regarding approval. As we prepare for a good outcome and subsequent market launch establishing narsoplimab as the first drug approved for life-threatening TA-TMA, we remain on track to read out Phase 3 data later this quarter from our ARTEMIS-IGAN trial aimed at bringing narsoplimab to the large market opportunity of high-proteinuria IgA nephropathy. Our next-generation MASP-2 inhibitor, OMS1029, is in the clinic, looking well-set to be a once-quarterly subcutaneously or intravenously administered therapeutic, and is slated to begin a Phase 2 program next summer – and behind it, progressing toward the clinic, is our orally available small-molecule MASP-2 inhibitor. In the other half of our complement franchise, our Phase 2 clinical asset, OMS906, continues to deliver data consistent with a premier drug targeting the premier enzyme in the alternative pathway, increasing confidence in our objective to make OMS906 the first-line, standard-of-care for a wide range of alternative pathway disorders. At NIDA’s request and with its significant grant funding, we are advancing OMS527, our oral PDE7 inhibitor, to a Phase 2 clinical study as a treatment for cocaine use disorder and are considering assessing the drug in a Phase 2 trial for Parkinson’s-related levodopa-induced dyskinesia, a crippling unmet need affecting millions of patients. Our cellular and molecular immuno-oncology platforms also continue to mature, and we are working hard to add them to our pipeline of clinical assets. With a cash runway forecasted to fund operations well into 2025, we are strongly positioned to drive our development programs and monetize our assets. Our team’s mission is to bring transformational therapeutics to patients who need them – and that requires relentless execution against our development milestones and objectives. I’m proud of the way the Omeros team has executed in the first half of 2023, and I expect that we will continue that positive momentum into the back half of the year.”
Second Quarter and Recent Clinical Developments
Financial Results
Net loss for the quarter ended June 30, 2023 was $37.3 million, or $0.59 per share. This compares to a net loss in the prior year quarter of $30.8 million, or $0.49 per share. Cash burn for the quarter ended June 30, 2023 was $30.1 million, an amount artificially inflated by $3.4 million corresponding to Rayner’s late payment of royalties received in July but due in June 2023.
For the second 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 royalties of $17.2 million during the second quarter of the prior year on U.S. net sales of $34.5 million. The recognition of the $200 million milestone payment from Rayner in December 2022 triggered a reduction of our U.S. base royalty rate from 50 percent to 30 percent. Royalties are recorded as a reduction of the OMIDRIA contract royalty asset on our balance sheet.
Total costs and expenses for the second quarter of 2023 were $40.9 million compared to $37.4 million for the second quarter of 2022. The increase was primarily due to the advancement of our OMS906 program and incremental clinical trial costs for narsoplimab. This increase was partially offset by reductions in selling, general and administrative expenses.
Interest expense during the second quarter of 2023 was $7.9 million compared to $4.9 million during the prior year quarter. The increase was due to interest on our OMIDRIA contract royalty obligation associated with the sale of a portion of our OMIDRIA royalty receivables, which we entered into during the third quarter of 2022.
During the second quarter of 2023, we earned $4.5 million in interest and other income compared to $0.7 million in the prior year quarter. The increase was due to higher average balances available to invest and higher market interest rates in the current year quarter.
Net income from discontinued operations, net of tax, was $7.0 million, or $0.11 per share, in the second quarter of 2023 compared to $10.8 million, or $0.17 per share, in the second quarter of 2022.
As of June 30, 2023, we had $341.3 million of cash and short-term investments, all of which are held in our name, available for operations and debt service. In addition, we had $11.2 million in accounts receivable.
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 5:30 a.m. Pacific Time; 8:30 a.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 (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 across multiple clinical programs for alternative pathway-related diseases, including paroxysmal nocturnal hemoglobinuria (PNH) and complement 3 (C3) glomerulopathy. 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 the Company’s 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, the Company’s 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 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||||||||||
(In thousands, except share and per share data) | ||||||||||||||||
|
| Three Months Ended |
| Six Months Ended | ||||||||||||
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| ||||||||||||||
|
| 2023 |
| 2022 |
| 2023 |
| 2022 | ||||||||
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|
| ||||
Costs and expenses: |
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|
|
|
|
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|
|
|
|
| ||||
Research and development |
| $ | 29,639 |
|
| $ | 23,516 |
|
| $ | 54,249 |
|
| $ | 47,603 |
|
Selling, general and administrative |
|
| 11,260 |
|
|
| 13,922 |
|
|
| 22,363 |
|
|
| 24,881 |
|
Total costs and expenses |
|
| 40,899 |
|
|
| 37,438 |
|
|
| 76,612 |
|
|
| 72,484 |
|
Loss from operations |
|
| (40,899 | ) |
|
| (37,438 | ) |
|
| (76,612 | ) |
|
| (72,484 | ) |
Interest expense |
|
| (7,932 | ) |
|
| (4,927 | ) |
|
| (15,865 | ) |
|
| (9,868 | ) |
Interest and other income |
|
| 4,537 |
|
|
| 670 |
|
|
| 8,500 |
|
|
| 1,163 |
|
Net loss from continuing operations |
|
| (44,294 | ) |
|
| (41,695 | ) |
|
| (83,977 | ) |
|
| (81,189 | ) |
Net income from discontinued operations |
|
| 7,000 |
|
|
| 10,846 |
|
|
| 12,982 |
|
|
| 17,329 |
|
Net loss |
| $ | (37,294 | ) |
| $ | (30,849 | ) |
| $ | (70,995 | ) |
| $ | (63,860 | ) |
|
|
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|
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Basic and diluted net income (loss) per share: |
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|
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|
|
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Net loss from continuing operations |
| $ | (0.70 | ) |
| $ | (0.66 | ) |
| $ | (1.34 | ) |
| $ | (1.30 | ) |
Net income from discontinued operations |
|
| 0.11 |
|
|
| 0.17 |
|
|
| 0.21 |
|
|
| 0.28 |
|
Net loss |
| $ | (0.59 | ) |
| $ | (0.49 | ) |
| $ | (1.13 | ) |
| $ | (1.02 | ) |
|
|
|
|
|
|
|
|
|
|
|
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Weighted-average shares used to compute basic and diluted net income (loss) per share |
|
| 62,837,125 |
|
|
| 62,730,015 |
|
|
| 62,832,991 |
|
|
| 62,727,395 |
|
OMEROS CORPORATION | ||||||||
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET | ||||||||
(In thousands) | ||||||||
|
| June 30, |
| December 31, | ||||
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Assets |
|
|
|
|
|
| ||
Current assets: |
|
|
|
|
|
| ||
Cash and cash equivalents |
| $ | 6,603 |
|
| $ | 11,009 |
|
Short-term investments |
|
| 334,680 |
|
|
| 183,909 |
|
OMIDRIA contract royalty asset, short-term |
|
| 29,084 |
|
|
| 28,797 |
|
Receivables |
|
| 11,190 |
|
|
| 213,221 |
|
Prepaid expense and other assets |
|
| 7,001 |
|
|
| 6,300 |
|
Total current assets |
|
| 388,558 |
|
|
| 443,236 |
|
OMIDRIA contract royalty asset |
|
| 115,802 |
|
|
| 123,425 |
|
Right of use assets |
|
| 20,258 |
|
|
| 21,762 |
|
Property and equipment, net |
|
| 1,749 |
|
|
| 1,492 |
|
Restricted investments |
|
| 1,054 |
|
|
| 1,054 |
|
Total assets |
| $ | 527,421 |
|
| $ | 590,969 |
|
|
|
|
|
|
|
| ||
Liabilities and shareholders’ equity |
|
|
|
|
|
| ||
Current liabilities: |
|
|
|
|
|
| ||
Accounts payable |
| $ | 9,552 |
|
| $ | 5,989 |
|
Accrued expenses |
|
| 29,793 |
|
|
| 30,551 |
|
Current portion of unsecured convertible senior notes, net |
|
| 94,730 |
|
|
| 94,381 |
|
Current portion of OMIDRIA royalty obligation |
|
| 4,777 |
|
|
| 1,152 |
|
Current portion of lease liabilities |
|
| 4,686 |
|
|
| 4,310 |
|
Total current liabilities |
|
| 143,538 |
|
|
| 136,383 |
|
Unsecured convertible senior notes, net |
|
| 221,516 |
|
|
| 220,906 |
|
OMIDRIA royalty obligation |
|
| 120,939 |
|
|
| 125,126 |
|
Lease liabilities, non-current |
|
| 20,422 |
|
|
| 22,426 |
|
Other accrued liabilities, non-current |
|
| 496 |
|
|
| 444 |
|
Shareholders’ equity: |
|
|
|
|
|
| ||
Common stock and additional paid-in capital |
|
| 727,222 |
|
|
| 721,401 |
|
Accumulated deficit |
|
| (706,712 | ) |
|
| (635,717 | ) |
Total shareholders’ equity |
|
| 20,510 |
|
|
| 85,684 |
|
Total liabilities and shareholders’ equity |
| $ | 527,421 |
|
| $ | 590,969 |
|
Last Trade: | US$10.31 |
Daily Change: | 0.07 0.68 |
Daily Volume: | 2,418,216 |
Market Cap: | US$597.460M |
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