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Omeros Corporation Reports Fourth Quarter and Year-End 2024 Financial Results

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Omeros (OMER) reported Q4 2024 financial results with a net loss of $31.4 million ($0.54 per share), compared to Q3 2024's loss of $32.2 million. The full-year 2024 net loss was $156.8 million ($2.70 per share), up from $117.8 million in 2023.

Cash position stood at $90.1 million as of December 31, 2024, marking an $81.7 million decrease from 2023. Significant outlays included $21.7 million for convertible notes repurchase, $19.1 million for narsoplimab drug substance, and $1.9 million for senior debt transactions.

Key developments include the resubmission of narsoplimab BLA for TA-TMA treatment, with FDA action expected in September 2025. The company plans to submit European MAA in H1 2025. Phase 3 trials for zaltenibart in PNH treatment have begun, with data expected late next year.

Omeros (OMER) ha riportato i risultati finanziari del Q4 2024, evidenziando una perdita netta di 31,4 milioni di dollari (0,54 dollari per azione), rispetto a una perdita di 32,2 milioni di dollari nel Q3 2024. La perdita netta per l'intero anno 2024 è stata di 156,8 milioni di dollari (2,70 dollari per azione), in aumento rispetto ai 117,8 milioni di dollari del 2023.

La posizione di cassa si attestava a 90,1 milioni di dollari al 31 dicembre 2024, segnando una diminuzione di 81,7 milioni di dollari rispetto al 2023. Le spese significative includevano 21,7 milioni di dollari per il riacquisto di note convertibili, 19,1 milioni di dollari per la sostanza del farmaco narsoplimab e 1,9 milioni di dollari per operazioni di debito senior.

Tra gli sviluppi chiave c'è la ri-sottomissione della BLA di narsoplimab per il trattamento della TA-TMA, con un'azione da parte della FDA prevista per settembre 2025. L'azienda prevede di presentare la MAA europea nel primo semestre del 2025. Sono iniziati gli studi di fase 3 per zaltenibart nel trattamento della PNH, con dati attesi entro la fine del prossimo anno.

Omeros (OMER) informó los resultados financieros del Q4 2024, con una pérdida neta de 31,4 millones de dólares (0,54 dólares por acción), en comparación con la pérdida de 32,2 millones de dólares en el Q3 2024. La pérdida neta del año completo 2024 fue de 156,8 millones de dólares (2,70 dólares por acción), un aumento respecto a los 117,8 millones de dólares en 2023.

La posición de efectivo se situó en 90,1 millones de dólares al 31 de diciembre de 2024, marcando una disminución de 81,7 millones de dólares respecto a 2023. Los gastos significativos incluyeron 21,7 millones de dólares para la recompra de notas convertibles, 19,1 millones de dólares para la sustancia del fármaco narsoplimab y 1,9 millones de dólares para transacciones de deuda senior.

Los desarrollos clave incluyen la re-sumisión de la BLA de narsoplimab para el tratamiento de TA-TMA, con acción de la FDA esperada para septiembre de 2025. La compañía planea presentar la MAA europea en el primer semestre de 2025. Han comenzado ensayos de fase 3 para zaltenibart en el tratamiento de PNH, con datos esperados a finales del próximo año.

Omeros (OMER)는 2024년 4분기 재무 결과를 발표했으며, 3,140만 달러의 순손실(주당 0.54달러)을 기록했습니다. 이는 2024년 3분기의 3,220만 달러 손실과 비교됩니다. 2024년 전체 연도의 순손실은 1억 5,680만 달러 (주당 2.70달러)로, 2023년의 1억 1,780만 달러에서 증가했습니다.

현금 보유액은 2024년 12월 31일 기준으로 9,010만 달러에 달하며, 2023년 대비 8,170만 달러 감소했습니다. 주요 지출 항목으로는 전환사채 매입을 위한 2,170만 달러, narsoplimab 약물 물질에 대한 1,910만 달러, 고급 부채 거래를 위한 190만 달러가 포함되었습니다.

주요 개발 사항으로는 narsoplimab BLA의 재제출이 있으며, TA-TMA 치료를 위한 FDA의 조치가 2025년 9월로 예상됩니다. 회사는 2025년 상반기에 유럽 MAA를 제출할 계획입니다. PNH 치료를 위한 zaltenibart의 3상 시험이 시작되었으며, 데이터는 내년 말에 예상됩니다.

Omeros (OMER) a annoncé les résultats financiers du Q4 2024, avec une perte nette de 31,4 millions de dollars (0,54 dollar par action), contre une perte de 32,2 millions de dollars au Q3 2024. La perte nette pour l'année entière 2024 s'élevait à 156,8 millions de dollars (2,70 dollars par action), en hausse par rapport à 117,8 millions de dollars en 2023.

La position de trésorerie était de 90,1 millions de dollars au 31 décembre 2024, marquant une diminution de 81,7 millions de dollars par rapport à 2023. Les dépenses significatives comprenaient 21,7 millions de dollars pour le rachat de notes convertibles, 19,1 millions de dollars pour la substance médicamenteuse narsoplimab, et 1,9 million de dollars pour des transactions de dette senior.

Les développements clés incluent la re-soumission du BLA de narsoplimab pour le traitement de la TA-TMA, avec une action de la FDA attendue en septembre 2025. L'entreprise prévoit de soumettre une MAA européenne au premier semestre 2025. Les essais de phase 3 pour zaltenibart dans le traitement de la PNH ont commencé, avec des données attendues d'ici la fin de l'année prochaine.

Omeros (OMER) berichtete über die finanziellen Ergebnisse des Q4 2024 mit einem Nettoverlust von 31,4 Millionen Dollar (0,54 Dollar pro Aktie), verglichen mit einem Verlust von 32,2 Millionen Dollar im Q3 2024. Der Nettoverlust für das gesamte Jahr 2024 betrug 156,8 Millionen Dollar (2,70 Dollar pro Aktie), ein Anstieg von 117,8 Millionen Dollar im Jahr 2023.

Die Liquiditätsposition betrug zum 31. Dezember 2024 90,1 Millionen Dollar, was einem Rückgang von 81,7 Millionen Dollar im Vergleich zu 2023 entspricht. Zu den erheblichen Ausgaben gehörten 21,7 Millionen Dollar für den Rückkauf von wandelbaren Anleihen, 19,1 Millionen Dollar für den Wirkstoff narsoplimab und 1,9 Millionen Dollar für Transaktionen mit vorrangigen Schulden.

Wichtige Entwicklungen umfassen die erneute Einreichung des BLA für narsoplimab zur Behandlung von TA-TMA, wobei mit einer Entscheidung der FDA im September 2025 gerechnet wird. Das Unternehmen plant, im ersten Halbjahr 2025 einen europäischen MAA einzureichen. Die Phase-3-Studien für zaltenibart zur Behandlung von PNH haben begonnen, wobei Daten für Ende nächsten Jahres erwartet werden.

Positive
  • Narsoplimab BLA resubmitted with strong survival data across all comparative analyses
  • Phase 3 trials for zaltenibart in PNH treatment initiated with potential superiority claims over C5 inhibitors
  • Secured $4.02 million NIDA funding for OMS527 cocaine use disorder clinical trial
Negative
  • Full-year net loss increased to $156.8M in 2024 from $117.8M in 2023
  • Cash position decreased by $81.7M to $90.1M during 2024
  • Significant cost outlays of $42.7M impacting cash reserves

Insights

Omeros' financial results reveal deepening annual losses with 2024 net loss increasing to $156.8 million ($2.70/share) compared to $117.8 million in 2023, while cash reserves declined by $81.7 million to $90.1 million. This cash burn rate requires monitoring, particularly with significant cost outlays of $42.7 million for debt management and drug production.

The critical value driver is the narsoplimab BLA resubmission for transplant-associated TMA with a likely September 2025 PDUFA date. The survival data is compelling – showing statistically significant superiority with a hazard ratio of 0.32 (p<0.00001) versus external controls. This robust dataset includes positive outcomes in both treatment-naïve patients and those who failed prior therapies, suggesting potential broad clinical utility.

The company's pipeline progression appears on track with Phase 3 activation for zaltenibart in PNH and $4.02 million NIDA funding secured for OMS527 in cocaine use disorder. However, with no immediate revenue sources and approximately 10-11 months of cash at current burn rates, the company faces a potential financing event before the September 2025 PDUFA date unless spending is substantially reduced or non-dilutive capital is secured through partnerships for ex-US rights, which management has indicated they are pursuing.

– Conference Call Today at 4:30 p.m. ET –

SEATTLE--(BUSINESS WIRE)-- Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the fourth quarter and year ended December 31, 2024, which include:

  • Net loss for the fourth quarter of 2024 was $31.4 million, or $0.54 per share, compared to a net loss of $32.2 million, or $0.56 per share for the third quarter of 2024.
  • For the year ended December 31, 2024, net loss was $156.8 million, or $2.70 per share, compared to a net loss of $117.8 million, or $1.88 per share in the prior year. The change in net loss reflects a $33.2 million decrease in the noncash gain from the remeasurement of the OMIDRIA contract royalty asset, a $6.6 million decrease in interest income earned and a $4.1 million gain on the early extinguishment of debt in December 2023, which were partially offset by a $6.2 million decrease in interest expense as a result of our debt repurchases and refinancing.
  • At December 31, 2024, we had $90.1 million of cash and short-term investments available for operations and debt servicing, a decrease of $81.7 million from December 31, 2023. We incurred significant cost outlays during the year representing a total of $42.7 million. These cost outlays are comprised of $21.7 million in payments related to repurchasing our convertible senior notes maturing in 2026, $19.1 million in charges related to delivery of narsoplimab drug substance and $1.9 million of costs related to our senior debt transaction.
  • Earlier this month, we successfully resubmitted our biologics license application (“BLA”) for narsoplimab, our lead antibody targeting MASP-2 and the lectin pathway of complement, in hematopoietic stem cell transplant-associated thrombotic microangiopathy (“TA-TMA”). The resubmitted BLA includes the previously announced results of a protocol and statistical analysis plan that we developed with input from FDA to compare survival in TA-TMA patients treated with narsoplimab to survival in an external control population of TA-TMA patients who did not receive narsoplimab. We expect the target date for FDA action under the Prescription Drug User Fee Act (“PDUFA”) to be six months following the date of resubmission to FDA, meaning, in this case, the PDUFA date would be in September 2025.
  • We expect to submit our European marketing authorization application (“MAA”) for narsoplimab in TA-TMA in the first half of 2025. The European Medicines Agency (“EMA”) has appointed rapporteurs from Germany and Austria responsible to coordinate review by EMA’s Committee for Human Medicinal Products of the anticipated MAA for narsoplimab. At upcoming meetings scheduled with representatives from both rapporteur countries, Omeros will orient the representatives to the data included in the application. EMA has confirmed narsoplimab’s eligibility for centralized review of a single MAA that, if approved, authorizes the product to be marketed in all EU member states and European Economic Area countries.
  • Site activation has begun in our Phase 3 development program evaluating zaltenibart (formerly known as OMS906), our lead MASP-3 antibody targeting the key and most proximal activator of the alternative pathway of complement, for the treatment of paroxysmal nocturnal hemoglobinuria (“PNH”). Similar to our Phase 2 program in this indication, our Phase 3 program includes a study treating PNH patients who are not receiving a complement-inhibitor, as well as a “switch-over” study in PNH patients who have had an unsatisfactory response to ravulizumab, an inhibitor of complement component 5 (“C5”).

“We are pleased to announce that our narsoplimab BLA for the treatment of TA-TMA was resubmitted to FDA earlier this month, with the MAA slated for European submission in the coming quarter,” stated Gregory A. Demopulos, M.D., Chairman and CEO of Omeros. “All study results in the BLA are uniformly strong across all comparative analyses and all datasets – the primary and primary-related sensitivity analyses, the 136-patient expanded access program, adults and children, and patients who had failed treatment with other off-label agents prior to receiving narsoplimab. With a six-month review cycle from the date of resubmission, we look forward to working closely with FDA toward narsoplimab’s approval and our commercial team is well-prepared to execute a successful market launch. Zaltenibart’s compelling results in our Phase 2 PNH trials are highly predictive of the similarly designed and ongoing Phase 3 program in PNH, which remains on track to readout data late next year, and we are focused on establishing ex-U.S. partnerships for both zaltenibart and narsoplimab. Also later this year, we expect data from our NIDA-funded OMS527 trial in patients with cocaine use disorder. Collectively, these programs in BLA review and with near-term clinical trial results translate to significant shareholder value.”

Fourth Quarter and Recent Clinical Developments

  • Recent developments regarding our program targeting mannan-binding lectin-associated serine protease-2 (“MASP-2”) and the lectin pathway of complement include the following:
    • The BLA for narsoplimab resubmitted to FDA in March 2025 includes the results of a protocol and statistical analysis plan that we developed with input from FDA, including final comments received subsequent to our most recent meeting with the agency in September 2024. The primary endpoint under the analysis plan is patient survival in our pivotal narsoplimab trial (OMS721-TMA-001) compared to that in an external registry of TA-TMA patients who were not treated with narsoplimab. Analyses similar to the primary analysis comparing survival in TA-TMA patients treated with narsoplimab under our global expanded access program (“EAP”) to that of similarly at-risk TA-TMA registry patients were also included in the analysis plan, along with sensitivity analyses related to each of the primary and EAP comparisons. All statistical analyses were conducted by an independent statistical group and the results were previously announced.
      • Narsoplimab met its primary statistical analysis endpoint comparing overall survival in the 28 TA-TMA patients in the pivotal trial for narsoplimab in TA-TMA (OMS721-TMA-001), to that of more than 100 similarly high-risk TA-TMA patients in an external control registry of TA-TMA patients who did not receive narsoplimab treatment. OMS721-TMA-001 patients demonstrated clinically meaningful and statistically significant superiority in overall survival – a hazard ratio of 0.32 (95% confidence interval: 0.23 to 0.44) with p-value less than 0.00001 – compared to the TA-TMA patients in the external registry.
      • The EAP-related analyses, which comprise multiple survival comparisons between narsoplimab-treated EAP patients and similarly at-risk TA-TMA patients in the external control registry, further support the robustness of the primary analysis results, with representative analyses of the combined EAP and pivotal trial patients yielding hazard ratios ranging from 0.34 (95% confidence interval: 0.21, 0.53) to 0.46 (95% confidence interval: 0.35, 0.60) and p-values ranging from less than 0.00001 to 0.00002.
      • Results of the primary-related and EAP-related sensitivity analyses performed as part of the statistical analysis plan support the robustness of the primary results. The EAP includes adults and children and includes both treatment-naïve patients and patients who failed or stopped treatment for their TA-TMA prior to receiving narsoplimab. Analyses of survival across all of these subgroups of patients treated with narsoplimab show consistently impressive survival results regardless of age or prior treatment status.
    • Last month, two presentations reporting real world outcomes from TA-TMA patients treated with narsoplimab supplied by Omeros under the EAP were featured at the 2025 Tandem Meetings – the Transplantation & Cellular Therapy Meetings of the American Society for Transplantation and Cellular Therapy and the Center for International Blood and Marrow Transplant Research held February 12-15, 2025 in Honolulu, Hawaii. The first, a podium presentation, reported on the impressive survival in both adult and pediatric high-risk TA-TMA patients, including those who had failed one or more other TA-TMA-directed therapies (primarily eculizumab) prior to receiving narsoplimab. The second reported on high-risk TA-TMA patients who had failed eculizumab and were subsequently treated with narsoplimab, achieving an over three-fold increase in one-year survival compared to the reported survival in eculizumab-refractory patients of 20 percent or less.
    • Panels of leading international transplant experts have drafted two manuscripts directed to survival of narsoplimab-treated TA-TMA patients, which are under review and will be submitted for publication in premier peer-reviewed journals once finalized. The first compares survival in patients in the narsoplimab pivotal trial to survival in the same external control population of TA-TMA patients used in our BLA primary analysis and the second will detail the survival data in the 50 pediatric TA-TMA patients treated with narsoplimab under our expanded access program.
    • We continue to explore the potential of narsoplimab and MASP-2 inhibition in severe acute respiratory distress syndrome (“ARDS”) and have generated compelling data from established animal models across bacterial, viral and chemical-induced forms of ARDS. This work includes an ongoing study in animals infected with H5N1 avian influenza or “bird flu,” which some experts regard as a threat to become a global pandemic. A manuscript has already been drafted and awaits receipt of the H5N1 data. We also continue to advance a MASP-2/C1inh proprietary diagnostic assay for lectin pathway hyperactivation for use in severe acute and long COVID-19, ARDS, and other diseases and disorders.
    • We are identifying indications for our Phase 2 clinical development of OMS1029, our long-acting, next-generation MASP-2 inhibitor. OMS1029 drug product has been manufactured and stored in quantities sufficient to support a future Phase 2 clinical trial. Single- and multiple-ascending-dose Phase 1 studies of OMS1029 were previously completed and validate once quarterly subcutaneous administration of OMS1029 to effectively ablate MASP-2 activity in humans. OMS1029 has been well tolerated to date with no safety concerns identified.
  • Recent developments regarding zaltenibart, our lead monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (“MASP-3”), the key activator of the alternative pathway, include the following:
    • We have initiated our Phase 3 clinical program for zaltenibart in PNH, which is comprised of two studies: one treating PNH patients who are not receiving a complement-inhibitor, and the other treating PNH patients who have had an unsatisfactory response to the C5 inhibitor ravulizumab and utilizing a “switch-over” design similar to our Phase 2 study. Both studies in our Phase 3 program are designed to provide head-to-head comparisons with the C5 inhibitors and could produce data demonstrating the superiority of zaltenibart over the C5 inhibitors in these patient populations. These data would potentially form the basis for comparative superiority claims for promotion, enhanced market access, and pricing reflective of zaltenibart’s advantages.
    • Results from the zaltenibart monotherapy stage of our Phase 2 “switch-over” trial evaluating two doses of zaltenibart in PNH patients who have had an unsatisfactory response to the C5 inhibitor ravulizumab were presented in December 2024 at the Annual Meeting of the American Society of Hematology. The study, now completed, enrolled PNH patients receiving ravulizumab with zaltenibart added to provide combination therapy for 24 weeks. Those patients demonstrating a hemoglobin response with the combination therapy were then switched to zaltenibart monotherapy. Twelve of 13 enrolled patients continued to the monotherapy stage of the study. The interim results showed that in PNH patients experiencing substantial extravascular hemolysis while receiving ravulizumab, zaltenibart monotherapy resulted in sustained clinically meaningful improvements in both hemoglobin and absolute reticulocyte count and prevented both intravascular and extravascular hemolysis.
    • Our Phase 2 clinical trial evaluating zaltenibart in C3 glomerulopathy (“C3G”) is also open to enrollment in multiple countries and dosing in the study is ongoing. This study requires enrollment of a relatively small number of patients. Following completion of the Phase 2 study, and assuming strong evidence of efficacy, we plan to initiate a Phase 3 trial in C3G.
  • Recent developments regarding OMS527, our phosphodiesterase 7 (“PDE7”) inhibitor program focused on addictions and compulsive disorders as well as movement disorders, include:
    • In March 2025, the National Institute on Drug Abuse (“NIDA”), part of the National Institutes of Health confirmed its funding commitment for the upcoming year commencing April 1, 2025 in the amount of $4.02 million. This amount, part of a grant originally awarded in April 2023 to support development at NIDA’s direct request of our lead orally administered PDE7 inhibitor compound for the treatment of cocaine use disorder (“CUD”), is expected to fund an inpatient clinical trial assessing safety and efficacy of OMS527 in adult patients with CUD. The funding commitment followed the successful completion of NIDA-funded OMS527-cocaine interaction safety studies in which OMS527 was co-administered with cocaine in two animal species to rule out enhancement of the detrimental effects of cocaine.
    • In the OMS527-cocaine interaction studies, OMS527, when administered at two different doses in combination with cocaine did not enhance the adverse cocaine effects in rats or non-human primates. Instead, the higher doses of OMS527 generally lessened the severity of effects noted following intravenous administration of cocaine, most notably decreasing convulsant-related activity following the administration of cocaine.
    • Work on the planned randomized, double-blind, parallel-group, inpatient Phase 1b clinical trial comparing the safety and efficacy of OMS527 to placebo in the treatment of adults with CUD is underway, and a preliminary data readout from that study is targeted by year-end 2025.
  • Recent developments regarding our oncology platform comprising signaling-driven immunomodulators, oncotoxins, and an adoptive T-cell technology combined with an immunostimulator, include:
    • In vitro and in vivo studies are rapidly advancing and support the potential of our oncology platform to deliver broadly effective and safe cancer treatments to overcome the shortcomings of currently marketed therapies. These programs are currently operating in “stealth” mode while we continue to secure our intellectual property estate around these technologies. Over the past several months we have engaged in confidential discussions to seek input and guidance from leading therapeutic-area experts and their uniformly positive response has been encouraging. We plan to share further information on these programs publicly in the near term.

Financial Results

Net loss for the fourth quarter of 2024 was $31.4 million, or $0.54 per share, compared to a net loss of $32.2 million, or $0.56 per share for the third quarter of 2024.

For the year ended December 31, 2024, our net loss was $156.8 million, or $2.70 per share, compared to a net loss of $117.8 million, or $1.88 per share in the prior year period. The change in net loss reflects a $33.2 million decrease in the noncash gain from the remeasurement of the OMIDRIA contract royalty asset, a $6.6 million decrease in interest income earned and a $4.1 million gain on the early extinguishment of debt in December 2023, which were partially offset by a $6.2 million decrease in interest expense as a result of our debt repurchases and refinancing.

At December 31, 2024, we had $90.1 million of cash and short-term investments available for operations and debt service, a decrease of $81.7 million from December 31, 2023. We incurred significant cost outlays during the year representing a total of $42.7 million. These cost outlays are comprised of $21.7 million in payment related to repurchasing our convertible senior notes maturing in 2026, $19.1 million in charges related to delivery of narsoplimab drug substance and $1.9 million of costs related to our senior credit transaction. Our cash used in operations for the fourth quarter was $29.0 million.

For the fourth quarter of 2024, we earned OMIDRIA royalties of $10.1 million on Rayner’s U.S. net sales of $33.6 million. This compares to earned OMIDRIA royalties of $9.3 million during the third quarter of 2024 on U.S. net sales of $31.0 million.

Total operating expenses for the fourth quarter of 2024 were $35.7 million compared to $35.4 million for the third quarter of 2024.

Interest expense during the fourth quarter of 2024 was $3.2 million compared to $4.1 million during the prior quarter. The decrease was primarily due to the remeasurement of the OMIDRIA royalty obligation.

We earned $2.3 million, respectively, for both the fourth and third quarters of 2024 in interest and other income.

Net income from discontinued operations, net of tax, was $5.2 million for the fourth quarter of 2024 compared to $4.9 million in the prior 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 https://register-conf.media-server.com/register/BIfd61371fd0fb44c1a0e7bdc80c36e0f8 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 first-in-class small-molecule and protein therapeutics for large-market and orphan indications targeting immunologic disorders, including complement-mediated diseases and cancers, as well as 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 has successfully completed Phase 1 single- and multiple-ascending dose clinical studies. Zaltenibart, Omeros’ inhibitor of MASP-3, the key activator of the alternative pathway of complement, is in Phase 3 clinical development for paroxysmal nocturnal hemoglobinuria and is being evaluated in an ongoing Phase 2 clinical trial for 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. Omeros also is advancing a broad portfolio of novel cellular and molecular immuno-oncology programs. 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 PDUFA date for FDA review of the biologics license application for narsoplimab, the anticipated submission to EMA of a marketing authorization application for narsoplimab, the prospects for obtaining FDA or EMA 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, expectations regarding future cash expenditures, and expectations regarding the sufficiency and availability of our capital resources to fund current and planned operations including the potential commercialization of narsoplimab if it is approved by FDA or EMA, 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, unfavorable or unexpected interpretation of our statistical analyses relating to an external registry of TA-TMA patients, potential differences between the diagnostic criteria used in our pivotal trial and in the external registry, and whether FDA and the EMA determine the registry used in our statistical analysis is sufficiently representative of TA-TMA patients, unanticipated or unexpected outcomes of regulatory processes in relevant jurisdictions, unproven preclinical and clinical development activities, our financial condition and results of operations and our ability to raise capital when necessary to continue our operations, regulatory processes and oversight, challenges associated with manufacture or supply of our products to support clinical trials, regulatory inspections and/or commercial sale following any marketing approval, 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 March 31, 2025, and in our subsequently filed quarterly reports on Form 10-Q. 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 CONSOLIDATED STATEMENTS OF OPERATIONS AND COMPREHENSIVE LOSS

(In thousands, except share and per share data) 

 

Three Months Ended

 

Year Ended

 

December 31,

 

December 31,

 

2024

 

2023

 

2024

 

2023

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

Research and development

 

$

23,320

 

 

$

28,890

 

 

$

119,523

 

 

$

114,870

 

Selling, general and administrative

 

 

12,340

 

 

 

10,875

 

 

 

49,735

 

 

 

49,660

 

Total costs and expenses

 

 

35,660

 

 

 

39,765

 

 

 

169,258

 

 

 

164,530

 

Loss from operations

 

 

(35,660

)

 

 

(39,765

)

 

 

(169,258

)

 

 

(164,530

)

Interest expense

 

 

(3,177

)

 

 

(7,063

)

 

 

(24,675

)

 

 

(30,844

)

Interest and other income

 

 

2,296

 

 

 

3,429

 

 

 

11,304

 

 

 

16,342

 

Gain on early extinguishment of convertible senior notes

 

 

 

 

 

4,112

 

 

 

 

 

 

4,112

 

Net loss from continuing operations

 

 

(36,541

)

 

 

(39,287

)

 

 

(182,629

)

 

 

(174,920

)

Net income from discontinued operations, net of tax

 

 

5,183

 

 

 

30,219

 

 

 

25,814

 

 

 

57,107

 

Net loss

 

$

(31,358

)

 

$

(9,068

)

 

$

(156,815

)

 

$

(117,813

)

 

 

 

 

Basic and diluted net income (loss) per share:

 

 

 

 

Net loss from continuing operations

 

$

(0.63

)

 

$

(0.63

)

 

$

(3.14

)

 

$

(2.79

)

Net income from discontinued operations

 

 

0.09

 

 

 

0.48

 

 

 

0.44

 

 

 

0.91

 

Net loss

 

$

(0.54

)

 

$

(0.15

)

 

$

(2.70

)

 

$

(1.88

)

 

 

 

 

Weighted-average shares used to compute basic and diluted net income (loss) per share

 

 

57,987,961

 

 

 

62,440,772

 

 

 

58,170,931

 

 

 

62,739,227

 

OMEROS CORPORATION

UNAUDITED CONSOLIDATED BALANCE SHEET

(In thousands) 

 

December 31,

 

December 31,

 

2024

 

2023

Assets

 

 

Current assets:

 

 

Cash and cash equivalents

 

$

3,400

 

 

$

7,105

 

Short-term investments

 

 

86,732

 

 

 

164,743

 

OMIDRIA contract royalty asset, short-term

 

 

29,083

 

 

 

29,373

 

Receivables

 

 

7,739

 

 

 

8,096

 

Prepaid expense and other assets

 

 

7,166

 

 

 

8,581

 

Total current assets

 

 

134,120

 

 

 

217,898

 

OMIDRIA contract royalty asset

 

 

124,266

 

 

 

138,736

 

Right of use assets

 

 

14,961

 

 

 

18,631

 

Property and equipment, net

 

 

2,678

 

 

 

1,950

 

Restricted investments

 

 

1,054

 

 

 

1,054

 

Total assets

 

$

277,079

 

 

$

378,269

 

 

 

Liabilities and shareholders’ equity (deficit)

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

5,905

 

 

$

7,712

 

Accrued expenses

 

 

26,005

 

 

 

31,868

 

OMIDRIA royalty obligation, current

 

 

20,645

 

 

 

8,576

 

Current portion of term debt

 

 

21,000

 

 

 

 

Lease liabilities, current

 

 

5,971

 

 

 

5,160

 

Total current liabilities

 

 

79,526

 

 

 

53,316

 

OMIDRIA royalty obligation, non-current

 

 

195,612

 

 

 

116,550

 

Convertible senior notes, net

 

 

97,178

 

 

 

213,155

 

Long-term debt, net

 

 

69,405

 

 

 

 

Lease liabilities, non-current

 

 

13,466

 

 

 

18,143

 

Other accrued liabilities, non-current

 

 

4,501

 

 

 

2,088

 

Shareholders’ equity (deficit):

 

 

 

 

 

 

Common stock and additional paid-in capital

 

 

727,736

 

 

 

728,547

 

Accumulated deficit

 

 

(910,345

)

 

 

(753,530

)

Total shareholders’ deficit

 

 

(182,609

)

 

 

(24,983

)

Total liabilities and shareholders’ equity (deficit)

 

$

277,079

 

 

$

378,269

 

 

Jennifer Cook Williams

Cook Williams Communications, Inc.

Investor and Media Relations

IR@omeros.com

Source: Omeros Corporation

FAQ

What were Omeros (OMER) Q4 2024 financial results?

Q4 2024 net loss was $31.4 million ($0.54 per share), slightly improved from Q3 2024's loss of $32.2 million ($0.56 per share).

When is the FDA expected to decide on Omeros' narsoplimab BLA for TA-TMA?

The FDA PDUFA date for narsoplimab is expected in September 2025, six months after the March 2025 resubmission.

What is the current cash position of Omeros (OMER)?

As of December 31, 2024, Omeros had $90.1 million in cash and short-term investments, down $81.7 million from year-end 2023.

What were the major expenditures for Omeros (OMER) in 2024?

Major outlays totaled $42.7 million: $21.7M for convertible notes repurchase, $19.1M for narsoplimab drug substance, and $1.9M for senior debt transactions.

When will Omeros (OMER) submit the European marketing authorization application for narsoplimab?

Omeros plans to submit the European MAA for narsoplimab in TA-TMA treatment during the first half of 2025.
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