Full Press Release Details
Omeros Corporation Reports First Quarter 2023 Financial Results
- Conference Call Today at 4:30 p.m. ET -
SEATTLE, WA - May 9, 2023 - 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 first quarter ended March 31, 2023, which include:
"We are pleased with our progress during the first quarter as our team continues to deliver on important milestones," said Gregory A. Demopulos, M.D., Omeros' chairman and chief executive officer. "For our MASP-2 inhibitor narsoplimab, we are meeting with FDA this month to discuss our proposed analysis plan and confirm the specifics to be included in a BLA
resubmission for TA-TMA, and our Phase 3 IgA nephropathy trial remains on track for data read-out next quarter. Our long-acting MASP-2 inhibitor is set to begin enrolling its multiple-ascending-dose clinical trial this summer in the U.S. Enrollment is marching ahead in our OMS906 clinical program. The results to date in treatment-na ve PNH patients are impressive, making clear that our MASP-3 inhibitor OMS906 blocks alternative pathway activation and should be effective across AP-related diseases while potentially offering significant safety, efficacy and compliance advantages over other AP-targeting drugs. Now collaborating with and having received a $6.69 million award from NIDA, we are moving forward to assess our PDE7 inhibitor OMS527 in patients with cocaine use disorder. Our immuno-oncology franchise is also rapidly progressing across both our cellular and biologic platforms. Helping to fund the ongoing achievements of these and our other programs is the non-dilutive $200 million milestone payment received in February, forecast to extend our cash runway into 2025. This year has started well for Omeros, and we expect that momentum to continue."
First Quarter and Recent Clinical Developments
Both Hgb and LDH improvements are statistically significant at all time points in the trial; OMS906 has been well tolerated and there have been no safety signals of concern.
Net loss for the first quarter of 2023 was $33.7 million, or $0.54 per share. This compares to a net loss in the first quarter of 2022 of $33.0 million, or $0.53 per share. Net loss from continuing operations for the first quarter of 2023 was $39.7 million compared to $39.5 million in the first quarter of 2022, and $0.63 per share for both periods. Cash burn for the first quarter of 2023 was $23.6 million, exclusive of the $200 million milestone payment from Rayner, compared to $26.0 million in the fourth quarter of 2022.
During the first quarter of 2023, we earned royalties of $9.2 million on $30.7 million of Rayner's U.S. net sales of OMIDRIA. This compares to earned royalties of $13.8 million during the first quarter of the prior year on U.S. net sales of $27.7 million. These royalties were recorded as a reduction of the OMIDRIA contract royalty asset. Omeros received a $200 million milestone payment from Rayner in the first quarter of 2023 in connection with the Asset Purchase Agreement under which Rayner purchased our OMIDRIA business. The achievement of the milestone event in late December 2022 triggered a reduction of our U.S. base royalty rate from 50 percent to 30 percent.
Total costs and expenses for the first quarter of 2023 were $35.7 million compared to $35.0 million for the first quarter of 2022.
Interest expense during the first quarter of 2023 was $7.9 million compared to $4.9 million during the first quarter of 2022. 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 first quarter of 2023, we earned $4.0 million in interest and other income compared to $0.5 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 $6.0 million, or $0.09 per share, in the first quarter of 2023 compared to $6.5 million, or $0.10 per share, in the first quarter of 2022.
As of March 31, 2023, we had $371.4 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 $10.0 million in accounts receivable. Our cash provided by operations during the first quarter of 2023 was $174.5 million and included the $200.0 million collection of the Rayner milestone payment.
Conference Call Details
To access the live conference call via phone, please dial (800) 715-9871 from the United States and Canada or (646) 307-1963 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 (800) 770-2030 from the United States or Canada or (609) 800-9909 internationally. The replay access code is 8266699.
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 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 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.
Jennifer Cook Williams
Cook Williams Communications, Inc.
Investor and Media Relations
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS
(In thousands, except share and per share data)
| Three Months Ended March 31, | |||||||
| 2023 | 2022 | ||||||
| Costs and expenses: | |||||||
| Research and development | $ | 24,610 | $ | 24,087 | |||
| Selling, general and administrative | 11,103 | 10,959 | |||||
| Total costs and expenses | 35,713 | 35,046 | |||||
| Loss from continuing operations | (35,713) | (35,046) | |||||
| Interest expense | (7,933) | (4,941) | |||||
| Interest and other income | 3,963 | 493 | |||||
| Net loss from continuing operations | (39,683) | (39,494) | |||||
| Net income from discontinued operations, net of tax | 5,982 | 6,483 | |||||
| Net loss | $ | (33,701) | $ | (33,011) | |||
| Basic and diluted net income (loss) per share | |||||||
| Net loss from continuing operations | $ | (0.63) | $ | (0.63) | |||
| Net income from discontinued operations | 0.09 | 0.10 | |||||
| Net loss | $ | (0.54) | $ | (0.53) | |||
| Weighted-average shares used to compute basic and diluted net income (loss) per share | 62,828,765 | 62,724,775 |
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET
| March 31, | December 31, | |||||
| 2023 | 2022 | |||||
| Assets | ||||||
| Current assets: | ||||||
| Cash and cash equivalents | $ | 3,829 | $ | 11,009 | ||
| Short-term investments | 367,527 | 183,909 | ||||
| OMIDRIA contract royalty asset, short-term | 28,940 | 28,797 | ||||
| Receivables | 10,033 | 213,221 | ||||
| Prepaid expense and other assets | 6,708 | 6,300 | ||||
| Total current assets | 417,037 | 443,236 | ||||
| OMIDRIA contract royalty asset | 119,681 | 123,425 | ||||
| Right of use assets | 21,025 | 21,762 | ||||
| Property and equipment, net | 1,335 | 1,492 | ||||
| Restricted investments | 1,054 | 1,054 | ||||
| Total assets | $ | 560,132 | $ | 590,969 | ||
| Liabilities and shareholders' equity | ||||||
| Current liabilities: | ||||||
| Accounts payable | $ | 6,446 | $ | 5,989 | ||
| Accrued expenses | 30,821 | 30,551 | ||||
| Current portion of unsecured convertible senior notes, net | 94,554 | 94,381 | ||||
| Current portion of OMIDRIA royalty obligation | 2,943 | 1,152 | ||||
| Current portion of lease liabilities | 4,427 | 4,310 | ||||
| Total current liabilities | 139,191 | 136,383 | ||||
| Unsecured convertible senior notes, net | 221,209 | 220,906 | ||||
| OMIDRIA royalty obligation | 123,057 | 125,126 | ||||
| Lease liabilities, non-current | 21,287 | 22,426 | ||||
| Other accrued liabilities, non-current | 452 | 444 | ||||
| Shareholders' equity: | ||||||
| Common stock and additional paid-in capital | 724,354 | 721,401 | ||||
| Accumulated deficit | (669,418) | (635,717) | ||||
| Total shareholders' equity | 54,936 | 85,684 | ||||
| Total liabilities and shareholders' equity | $ | 560,132 | $ | 590,969 |