SEATTLE / May 15, 2024 / 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 first quarter ended March 31, 2024, which include:
“Our substantial progress and milestone achievements during the first quarter position Omeros well for continued success throughout 2024,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. “Through the sale of a portion of our OMIDRIA royalties in February, we have extended our cash runway into 2026. OMS906, our MASP-3 inhibitor, continues to perform impressively, having completed enrollment in two trials in our Phase 2 PNH program and initiated enrollment in our single Phase 2 trial in C3G, remaining on track to begin a Phase 3 program in PNH later this year and another in C3G early in 2025. OMS1029 continues to validate its promise as a once-quarterly-delivered MASP-2 inhibitor with a strong safety profile, ready to begin a Phase 2 program later this year. Our PDE7 inhibitor program OMS527 is advancing on schedule, fully funded by NIDA, and we are now evaluating clinical indications and development pathways for our novel immuno-oncology platforms, which are generating a steady stream of consistently exciting animal data. With FDA discussions ongoing, we are building a strong BLA package in support of narsoplimab in TA-TMA and look forward to making it the first approved therapeutic for patients with this often-lethal disease. As we survey our assets and their significant potential to benefit the lives of patients, the Omeros team is dedicated to adding to our accomplishments throughout the remainder of the year and beyond.”
First Quarter and Recent Clinical Developments
Financial Results
Net loss for the first quarter of 2024 was $37.2 million, or $0.63 per share, compared to a net loss in the prior year period of $33.7 million, or $0.54 per share. Net loss from continuing operations was $43.9 million in the current quarter compared to a net loss of $39.7 million in the prior year quarter.
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.
At March 31, 2024, we had $230.3 million of cash and short-term investments available for operations and debt service, an increase of $58.5 million from December 31, 2023. During the current quarter, we received $115.5 million from DRI in February 2024 and repurchased 3.2 million shares of our common stock for $11.9 million.
For the first quarter of 2024, we earned OMIDRIA royalties of $9.4 million on Rayner’s U.S. net sales of $31.2 million. This compares to earned OMIDRIA royalties of $9.2 million during the first quarter of 2023 on U.S. net sales of $30.7 million.
Total operating expenses for the first quarter of 2024 were $39.0 million compared to $35.7 million for the first quarter of 2023. The difference was primarily due to receipt of a $2.3 million Employee Retention Credit in the first quarter of 2023 and increased research and development costs in the first quarter of 2024. Patent and legal costs in the first quarter of 2024 also contributed to the increase.
Interest expense during the first quarter of 2024 was $8.2 million compared to $7.9 million during the prior year quarter. The increase was due to the increase in OMIDRIA royalty obligation due to the amended and restated royalty purchase agreement with DRI offset by the interest saved upon retiring the 2023 convertible notes in November 2023.
During the first quarter of 2024, we earned $3.4 million in interest and other income compared to $4.0 million in the first quarter of 2023. The difference is primarily due to cash and investments available to invest.
Net income from discontinued operations, net of tax, was $6.7 million, or $0.12 per share, in the first quarter of 2024 compared to $6.0 million, or $0.09 per share, in the first quarter of 2023. The increase was primarily attributable to increased non-cash interest earned on the OMIDRIA contract royalty asset and a higher remeasurement adjustment in the current year quarter.
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 the following URL to receive a unique PIN https://register.vevent.com/register/BI3ba84daabade401a89dff7dda08e2e4c. 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 toward Phase 3 clinical trials 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 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS | ||||||||
(In thousands, except share and per share data) | ||||||||
|
| Three Months Ended | ||||||
|
| March 31, | ||||||
|
| 2024 |
| 2023 | ||||
|
| |
| | ||||
Costs and expenses: |
| |
|
|
| |||
Research and development |
| $ | 26,770 |
|
| $ | 24,610 |
|
Selling, general and administrative |
|
| 12,264 |
|
|
| 11,103 |
|
Total costs and expenses |
|
| 39,034 |
|
|
| 35,713 |
|
Loss from operations |
|
| (39,034 | ) |
|
| (35,713 | ) |
Interest expense |
|
| (8,231 | ) |
|
| (7,933 | ) |
Interest and other income |
|
| 3,415 |
|
|
| 3,963 |
|
Net loss from continuing operations |
|
| (43,850 | ) |
|
| (39,683 | ) |
Net income from discontinued operations, net of tax |
|
| 6,666 |
|
|
| 5,982 |
|
Net loss |
| $ | (37,184 | ) |
| $ | (33,701 | ) |
|
| |
| | ||||
Basic and diluted net income (loss) per share: |
| |
| | ||||
Net loss from continuing operations |
| $ | (0.75 | ) |
| $ | (0.63 | ) |
Net income from discontinued operations |
|
| 0.12 |
|
|
| 0.09 |
|
Net loss |
| $ | (0.63 | ) |
| $ | (0.54 | ) |
|
| |
| | ||||
Weighted-average shares used to compute basic and diluted net income (loss) per share |
|
| 58,800,716 |
|
|
| 62,828,765 |
|
OMEROS CORPORATION | ||||||||
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET | ||||||||
(In thousands) | ||||||||
|
| March 31, |
| December 31, | ||||
|
| 2024 |
| 2023 | ||||
Assets |
| |
| | ||||
Current assets: |
| |
| | ||||
Cash and cash equivalents |
| $ | 1,831 |
|
| $ | 7,105 |
|
Short-term investments |
|
| 228,503 |
|
|
| 164,743 |
|
OMIDRIA contract royalty asset, short-term |
|
| 29,519 |
|
|
| 29,373 |
|
Receivables |
|
| 7,642 |
|
|
| 8,096 |
|
Prepaid expense and other assets |
|
| 13,463 |
|
|
| 8,581 |
|
Total current assets |
|
| 280,958 |
|
|
| 217,898 |
|
OMIDRIA contract royalty asset |
|
| 135,909 |
|
|
| 138,736 |
|
Right of use assets |
|
| 17,767 |
|
|
| 18,631 |
|
Property and equipment, net |
|
| 1,804 |
|
|
| 1,950 |
|
Restricted investments |
|
| 1,054 |
|
|
| 1,054 |
|
Total assets |
| $ | 437,492 |
|
| $ | 378,269 |
|
|
| |
| | ||||
Liabilities and shareholders’ equity (deficit) |
|
|
|
|
|
| ||
Current liabilities: |
|
|
|
|
|
| ||
Accounts payable |
| $ | 6,182 |
|
| $ | 7,712 |
|
Accrued expenses |
|
| 28,402 |
|
|
| 31,868 |
|
Current portion of OMIDRIA royalty obligation |
|
| 19,130 |
|
|
| 8,576 |
|
Current portion of lease liabilities |
|
| 5,342 |
|
|
| 5,160 |
|
Total current liabilities |
|
| 59,056 |
|
|
| 53,316 |
|
Convertible senior notes, net |
|
| 213,463 |
|
|
| 213,155 |
|
OMIDRIA royalty obligation |
|
| 217,459 |
|
|
| 116,550 |
|
Lease liabilities, non-current |
|
| 16,754 |
|
|
| 18,143 |
|
Other accrued liabilities, non-current |
|
| 2,088 |
|
|
| 2,088 |
|
Shareholders’ equity (deficit): |
|
|
|
|
|
| ||
Common stock and additional paid-in capital |
|
| 719,386 |
|
|
| 728,547 |
|
Accumulated deficit |
|
| (790,714 | ) |
|
| (753,530 | ) |
Total shareholders’ deficit |
|
| (71,328 | ) |
|
| (24,983 | ) |
Total liabilities and shareholders’ equity (deficit) |
| $ | 437,492 |
|
| $ | 378,269 |
|
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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