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Omeros Corporation Reports Second Quarter 2024 Financial Results

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Omeros (OMER) reported Q2 2024 financial results:

  • Net loss of $56.0 million ($0.97/share) vs $37.3 million ($0.59/share) in Q2 2023
  • Cash and short-term investments of $158.9 million as of June 30, 2024
  • OMIDRIA royalties of $10.9 million on $36.4 million U.S. net sales
  • Entered $67.1 million initial term loan agreement
  • Repurchased $118.1 million of 2026 convertible notes at 25% discount

Key clinical developments:

  • Ongoing FDA discussions for narsoplimab BLA resubmission in TA-TMA
  • Zaltenibart (OMS906) advancing in Phase 2 PNH trials
  • OMS1029 completed Phase 1 studies, supporting quarterly dosing

Omeros (OMER) ha riportato i risultati finanziari per il secondo trimestre del 2024:

  • Perdita netta di 56,0 milioni di dollari (0,97 dollari/azione) rispetto a 37,3 milioni di dollari (0,59 dollari/azione) nel secondo trimestre del 2023
  • Cassae investimenti a breve termine di 158,9 milioni di dollari al 30 giugno 2024
  • Royalties di OMIDRIA di 10,9 milioni di dollari su vendite nette negli USA di 36,4 milioni di dollari
  • Entrato in un accordo per un prestito iniziale di 67,1 milioni di dollari
  • Riacquistati 118,1 milioni di dollari di note convertibili del 2026 con uno sconto del 25%

Sviluppi clinici chiave:

  • Discussioni in corso con la FDA per la riesamina della BLA di narsoplimab in TA-TMA
  • Zaltenibart (OMS906) avanzando nella fase 2 delle sperimentazioni PNH
  • OMS1029 ha completato gli studi di fase 1, supportando la somministrazione trimestrale

Omeros (OMER) informó los resultados financieros del segundo trimestre de 2024:

  • Pérdida neta de 56,0 millones de dólares (0,97 dólares/acción) frente a 37,3 millones de dólares (0,59 dólares/acción) en el segundo trimestre de 2023
  • Efectivo e inversiones a corto plazo de 158,9 millones de dólares al 30 de junio de 2024
  • Regalías de OMIDRIA de 10,9 millones de dólares sobre ventas netas en EE.UU. de 36,4 millones de dólares
  • Entró en un acuerdo de préstamo inicial de 67,1 millones de dólares
  • Recompró 118,1 millones de dólares de notas convertibles de 2026 con un descuento del 25%

Desarrollos clínicos clave:

  • Discusiones en curso con la FDA sobre la reenvío de la BLA de narsoplimab en TA-TMA
  • Zaltenibart (OMS906) avanzando en ensayos de fase 2 de PNH
  • OMS1029 completó estudios de fase 1, apoyando la dosificación trimestral

오메로스 (OMER)는 2024년 2분기 재무 결과를 발표했습니다:

  • 순손실 5,600만 달러 (주당 0.97달러)로, 2023년 2분기에는 3,730만 달러 (주당 0.59달러)
  • 2024년 6월 30일 기준 현금 및 단기 투자액은 1억 5,890만 달러
  • OMIDRIA 로열티는 1,090만 달러이며, 미국 순 매출은 3,640만 달러입니다
  • 6,710만 달러의 초기 대출 계약 체결
  • 2026년 전환사채 1억 1,810만 달러를 25% 할인된 가격에 재매입함

주요 임상 개발:

  • TA-TMA에 대한 narsoplimab BLA 재제출을 위한 FDA와의 논의 중
  • Zaltenibart (OMS906) 2상 PNH 시험에서 진행 중
  • OMS1029는 분기별 투여를 지지하는 1상 연구를 완료함

Omeros (OMER) a annoncé les résultats financiers du deuxième trimestre 2024 :

  • Perte nette de 56,0 millions de dollars (0,97 dollar/action) contre 37,3 millions de dollars (0,59 dollar/action) au deuxième trimestre 2023
  • Trésorerie et investissements à court terme de 158,9 millions de dollars au 30 juin 2024
  • Royalty d'OMIDRIA de 10,9 millions de dollars sur des ventes nettes aux États-Unis de 36,4 millions de dollars
  • Signature d'un accord de prêt initial de 67,1 millions de dollars
  • Rachat de 118,1 millions de dollars d'obligations convertibles 2026 avec une remise de 25%

Développements cliniques clés :

  • Discussions en cours avec la FDA sur le renvoi de la BLA pour le narsoplimab dans le TA-TMA
  • Zaltenibart (OMS906) avance dans les essais de phase 2 pour le PNH
  • OMS1029 a terminé les études de phase 1, soutenant une posologie trimestrielle

Omeros (OMER) hat die Finanzkennzahlen für das zweite Quartal 2024 veröffentlicht:

  • Nettoverlust von 56,0 Millionen US-Dollar (0,97 USD/Aktie) im Vergleich zu 37,3 Millionen US-Dollar (0,59 USD/Aktie) im zweiten Quartal 2023
  • Barmittel und kurzfristige Investitionen von 158,9 Millionen US-Dollar zum 30. Juni 2024
  • OMIDRIA-Lizenzgebühren von 10,9 Millionen US-Dollar bei einem US-Nettoverkauf von 36,4 Millionen US-Dollar
  • Eintritt in einen Kreditvertrag über 67,1 Millionen US-Dollar
  • Wiedererwerb von 118,1 Millionen US-Dollar an wandelbaren Anleihen 2026 mit 25% Rabatt

Wichtige klinische Entwicklungen:

  • Aktuelle Diskussionen mit der FDA zur Neuerstellung des BLA für narsoplimab in TA-TMA
  • Zaltenibart (OMS906) schreitet in Phase-2-Tests für PNH voran
  • OMS1029 hat Phase-1-Studien abgeschlossen, die eine vierteljährliche Dosisverabreichung unterstützen
Positive
  • Secured $67.1 million initial term loan to strengthen balance sheet
  • Repurchased $118.1 million of 2026 convertible notes at 25% discount, reducing debt
  • OMIDRIA royalties increased to $10.9 million from $10.7 million year-over-year
  • Zaltenibart (OMS906) showed promising interim results in Phase 2 PNH trials
  • OMS1029 completed Phase 1 studies, supporting once-quarterly dosing potential
Negative
  • Net loss increased to $56.0 million from $37.3 million year-over-year
  • Cash and short-term investments decreased by $12.9 million from December 31, 2023
  • Operating expenses increased to $59.2 million from $40.9 million year-over-year
  • Interest expense increased to $9.2 million from $7.9 million year-over-year
  • Narsoplimab BLA resubmission for TA-TMA still pending FDA discussions

Omeros' Q2 2024 results reveal a widening net loss of $56.0 million ($0.97 per share), compared to $37.3 million in Q2 2023. This increase is primarily due to one-time charges totaling $40.7 million, including $17.6 million for narsoplimab drug substance and $21.2 million for debt repurchase. Despite these charges, the company's cash position remains relatively strong at $158.9 million.

The company's debt restructuring is noteworthy, reducing the 2026 Notes by 55% at a 25% discount. This move, along with the new Credit Agreement, improves Omeros' financial flexibility. However, investors should monitor the company's burn rate and potential need for additional financing, given the ongoing clinical trials and regulatory processes.

Omeros is making significant progress in its clinical pipeline. The company's lead candidate, narsoplimab for TA-TMA, is in ongoing discussions with the FDA for BLA resubmission. The establishment of FDA's Rare Disease Innovation Hub could potentially benefit Omeros in this process.

The MASP-3 inhibitor zaltenibart (OMS906) is showing promising results in PNH trials, with significant hemoglobin improvements and plans for Phase 3 trials later this year. The development of OMS1029, a long-acting MASP-2 inhibitor and exploration of its potential in wet AMD, represents an intriguing opportunity in a large market.

While these advancements are encouraging, investors should be aware that regulatory hurdles and clinical trial outcomes remain key risks.

Omeros' OMIDRIA royalties show modest growth, with $10.9 million earned in Q2 2024 compared to $10.7 million in Q2 2023. This steady performance provides a reliable revenue stream to support ongoing R&D efforts.

The company's focus on rare diseases and unmet medical needs, particularly in TA-TMA and PNH, positions it in potentially lucrative niche markets. The exploration of wet AMD with OMS1029 could open up a significantly larger market opportunity if successful.

However, investors should consider the competitive landscape in these areas and the long timelines typically associated with drug development and approval. The company's ability to successfully navigate regulatory processes and bring products to market will be important for long-term success.

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

SEATTLE--(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, as well as cancers and addictive and compulsive disorders, today announced recent highlights and developments as well as financial results for the second quarter ended June 30, 2024, which include:

  • Net loss for the second quarter of 2024 was $56.0 million, or $0.97 per share, compared to a net loss of $37.3 million, or $0.59 per share for the second quarter of 2023. For the six months ended June 30, 2024, our net loss was $93.2 million, or $1.60 per share, compared to a net loss of $71.0 million, or $1.13 per share in the prior year period. The second quarter of 2024 includes a $17.6 million charge for narsoplimab drug substance delivered during the quarter, the manufacturing of which commenced in October 2023, a $21.2 million payment for term loan-related debt repurchase, and $1.9 million of term loan-related transaction costs. These significant cash outlays, representing a total of $40.7 million dollars, are not expected to be repeated in the foreseeable future.
  • On June 3, 2024, we entered into a Credit and Guaranty Agreement (the “Credit Agreement”) with funds managed by Athyrium Capital Management (collectively, “Athyrium”) and funds managed by Highbridge Capital Management (collectively, “Highbridge”) as lenders (the “Lenders”). Under the Credit Agreement, we entered into an initial senior secured term loan of $67.1 million (the “Initial Term Loan”) and paid $21.2 million to the Lenders in exchange for $118.1 million aggregate principal amount of Omeros’ existing 5.25 percent convertible senior notes due on February 15, 2026 (the “2026 Notes”) held by the Lenders and representing 55 percent of our total 2026 Notes. The Credit Agreement also provides for a $25.0 million delayed draw term loan available to be drawn on request by Omeros on or prior to June 3, 2025 contingent on regulatory approval of narsoplimab in hematopoietic stem cell transplant-associated thrombotic microangiopathy (“TA-TMA”). All loans under the Credit Agreement have a stated maturity date of June 3, 2028.
    • The purchase price in the debt exchange and repurchase of our outstanding 2026 Notes represents a discount from notional value of approximately 25 percent.
    • Neither the Initial Term Loan nor the delayed draw term loan includes equity consideration for the Lenders, preventing any shareholder dilution as a consequence of these transactions.
    • After giving effect to the repurchase, we had approximately $98 million principal amount of our 2026 Notes outstanding.
  • At June 30, 2024, we had $158.9 million of cash and short-term investments available for operations and debt servicing, a decrease of $12.9 million from December 31, 2023.
  • As previously disclosed, we submitted an analysis plan to assess our existing clinical trial data along with other evidence proposed to be included in a resubmission of our biologics license application (“BLA”) for narsoplimab in TA-TMA. We are engaged in ongoing discussions with the FDA regarding the analysis plan and the other evidence proposed to be included in the submission. An additional meeting with FDA has been scheduled and we expect to provide a further update on our plans for resubmission and anticipated timing when more definitive information becomes available.
  • We continued advancing our lead MASP-3 inhibitor antibody zaltenibart (also known as OMS906) through a Phase 2 development program in paroxysmal nocturnal hemoglobinuria (“PNH”) comprised of two fully enrolled clinical trials and a long-term extension study in which patients who have completed either of the first two studies are eligible to enroll. Patients continue to accrue to the extension study and we remain on track to initiate our Phase 3 program for zaltenibart in PNH later this year.
  • Enrollment is ongoing in our Phase 2 clinical trial evaluating zaltenibart for the treatment of complement 3 glomerulopathy (“C3G”). A Phase 3 program in C3G is planned to begin in early 2025.

“Throughout the second quarter, we continued rapidly progressing our clinical programs while significantly strengthening our balance sheet,” said Gregory A. Demopulos, M.D., Omeros’ chairman and chief executive officer. “Through the term loan and note repurchase transaction completed in June, we reduced by more than half the outstanding balance of our 2026 convertible notes at a substantial discount to par value without diluting shareholders. With the new secured term loan in place, a substantial portion of our outstanding debt is now maturing in 2028, the Company is well positioned to address the remaining balance of our 2026 convertible notes, and we have access to an additional term loan of up to $25 million to fund the commercial launch of narsoplimab in TA-TMA. Although the lengthy regulatory process is a continuing source of frustration for our team, our shareholders and, most especially, the TA-TMA patients in need of an effective treatment for this often-lethal condition, we believe that the evidence we have proposed to submit with our BLA is highly compelling and we remain dedicated to making narsoplimab the first approved product for the treatment of TA-TMA. We look forward to providing a further update on the outcome of our ongoing discussions with FDA. In parallel, our MASP-3 inhibitor zaltenibart continues to advance rapidly, generating consistently – and compared to other marketed and developing alternative pathway inhibitors – strong data, and it remains on track to initiate a Phase 3 program in PNH later this year and, in C3G, early in 2025.”

Second Quarter and Recent Clinical Developments

  • Recent developments regarding narsoplimab, our lead monoclonal antibody targeting mannan-binding lectin-associated serine protease-2 (“MASP-2”), include the following:
    • We previously submitted to FDA an analysis plan to assess already existing clinical trial data, existing data from an historical control population available from an external source, data from the narsoplimab expanded access (i.e., compassionate use) program, and data directed to the mechanism of action of narsoplimab. We are having ongoing discussions with the agency regarding the proposed analysis plan and FDA’s requirements for our resubmission of our BLA. An additional meeting with FDA has been scheduled and we expect to provide a further update on our plans for resubmission and the anticipated timing when more definitive information becomes available.
    • FDA recently announced the establishment of the Rare Disease Innovation Hub, which will serve as a single point of connection and engagement within the FDA to support the development of treatments and products for rare diseases. The hub will have a particular focus on products intended for smaller populations or for diseases where the natural history is variable and not fully understood. FDA’s focus on these issues and their responsiveness to the rare disease community’s advocacy is encouraging, and we view the establishment of the hub as a tangible demonstration of FDA’s commitment to recognizing and addressing the unique challenges faced in developing therapies for these conditions.
    • In addition to previous publications on narsoplimab in TA-TMA, international transplant experts are preparing two manuscripts – one directed to the results of a survival comparison between our pivotal trial of narsoplimab in TA-TMA and an external control population of TA-TMA patients and the second detailing the survival data obtained from narsoplimab treatment of TA-TMA patients in our expanded access program. Physicians continue to request access to narsoplimab under this program for their patients with TA-TMA. Given that there is no approved treatment for this life-threatening condition, we continue to do what we can to help these patients.
  • Recent developments regarding OMS1029, our long-acting, next-generation MASP-2 inhibitor, include:
    • Both the single- and multiple-ascending-dose Phase 1 studies of OMS1029 have now been completed. The results support once-quarterly dosing, administered either subcutaneously or intravenously. Data from the multiple-ascending-dose study will be utilized to inform dose selection for continued clinical development. Consistent with the results of the single-ascending-dose Phase 1 clinical trial of OMS1029 completed in early 2023, OMS1029 was generally well tolerated at all doses evaluated in the multiple-ascending-dose study, with no significant safety concern identified to date.
    • We continue to evaluate large market indications for Phase 2 clinical development of OMS1029. These include neovascular age-related macular degeneration, sometimes referred to as “wet AMD.” MASP-2 inhibition previously showed efficacy in a pre-clinical murine model of wet AMD and we are currently engaged in a primate study comparing OMS1029 to Eylea (afibercept), a product currently approved to treat wet AMD. If shown to be effective, OMS1029 administered systemically (e.g., either intravenously or subcutaneously) could represent a significantly more attractive treatment experience compared to Eylea and other currently approved treatments for wet AMD, which require frequent injections directly into the posterior chamber of the eye.
  • Recent developments regarding OMS906, our lead monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 (“MASP-3”), the key activator of the alternative pathway, include:
    • The United States Adopted Names Council (“USAN”), in consultation with the World Health Organization’s International Nonproprietary Names Expert Committee (“INN”), recently selected the nonproprietary name “zaltenibart” for OMS906. The USAN Council, by working closely with the INN Programme of the World Health Organization and various national nomenclature groups, aims for global standardization and unification of drug nomenclature to ensure that drug information is communicated accurately and unambiguously. Going forward, we will use the name zaltenibart to refer to our lead MASP-3 antibody in publications, at conferences and across other forums.
    • Our Phase 2 trial evaluating two doses of zaltenibart in PNH patients who have had an unsatisfactory response to the C5 inhibitor ravulizumab has continued to produce encouraging data. The study utilizes a “switch-over” design, enrolling PNH patients who are receiving ravulizumab and adding zaltenibart to provide combination therapy with ravulizumab for 24 weeks. Those patients who demonstrate a hemoglobin response with the combination therapy are then switched to zaltenibart monotherapy. In June, at the annual congress of the European Hematology Association, interim analysis results from the combination therapy portion of the trial were presented by Dr. Morag Griffin, an internationally recognized PNH expert from St. James University Hospital in England. During the adjunctive therapy period, the statistically significant mean hemoglobin improvement from baseline was 3.27 g/dL and 10 of 12 patients advanced to monotherapy. Absolute reticulocyte count also demonstrated statistically significant improvement. Zaltenibart was safe and well tolerated. An abstract providing results of the zaltenibart monotherapy stage has been submitted to the American Society of Hematology for presentation at their annual meeting in December. The efficacy and safety profiles of zaltenibart as monotherapy remain strong, including demonstration of sustained and clinically meaningful improvements in hemoglobin levels and absolute reticulocyte counts as well as prevention of both extravascular and intravascular hemolysis.
    • Our Phase 2 study of zaltenibart in PNH patients who have not previously received treatment with a complement inhibitor (i.e., naïve patients) is also ongoing and continues to progress well. Results from an interim analysis of subcutaneous zaltenibart treatment were presented at the American Society of Hematology meeting held in December 2023. Following that presentation, we amended the study protocol to identify the plasma concentrations and the level of MASP-3 inhibition required to inhibit breakthrough hemolysis. These data, in combination with data derived from our “switch-over” PNH study and from our Phase 1 studies in healthy subjects, are expected to provide all the data needed to finalize selection of the zaltenibart dose for our upcoming Phase 3 clinical trials.
    • We plan to conduct two trials in our Phase 3 program for zaltenibart in PNH. Similar to our Phase 2 program, one will enroll complement inhibitor-naïve patients and the other will employ a “switch over” design. Through our recent advisory boards with experts in PNH and focus-group PNH patients, we have received valuable input to inform the design of our Phase 3 studies and our positioning of zaltenibart in the marketplace, if approved. The zaltenibart drug substance necessary to supply our Phase 3 clinical trials has been manufactured, upcoming pre-Phase 3 meetings with both European and U.S. regulators have been scheduled or requested, and the other activities required to initiate our Phase 3 program have also been completed or are progressing as planned. We remain on track to initiate the program later this year.
  • Recent developments regarding OMS527, our phosphodiesterase 7 (“PDE7”) inhibitor program focused on addictions and compulsive disorders as well as movement disorders, include:
    • In April 2023 we were awarded a three-year, $6.69 million grant by the National Institute on Drug Abuse (“NIDA”) to pursue development of our lead orally administered PDE7 inhibitor compound for the treatment of cocaine use disorder (“CUD”). We expect to complete by the end of this year a grant-funded preclinical cocaine interaction study, which is a safety prerequisite to initiation of the randomized, placebo-controlled, inpatient clinical study evaluating the safety and effectiveness of OMS527 in patients with CUD, which is also contemplated to be funded with proceeds of the NIDA award.

Financial Results

Net loss for the second quarter of 2024 was $56.0 million, or $0.97 per share, compared to a net loss of $37.3 million, or $0.59 per share for the second quarter of 2023. For the six months ended June 30, 2024, our net loss was $93.2 million, or $1.60 per share, compared to a net loss of $71.0 million, or $1.13 per share in the prior year period. The second quarter of 2024 includes a $17.6 million charge for narsoplimab drug substance that was delivered during the quarter, the manufacturing of which commenced in October 2023, a $21.2 million payment for debt repurchase, and $1.9 million of costs related to the debt transaction. We expense all manufacturing activities until approval in the U.S. and Europe is reasonably assured.

At June 30, 2024, we had $158.9 million of cash and short-term investments available for operations and debt service, a decrease of $12.9 million from December 31, 2023.

For the second quarter of 2024, we earned OMIDRIA royalties of $10.9 million on Rayner’s U.S. net sales of $36.4 million. This compares to earned OMIDRIA royalties of $10.7 million during the second quarter of 2023 on U.S. net sales of $35.7 million.

Total operating expenses for the second quarter of 2024 were $59.2 million compared to $40.9 million for the second quarter of 2023. The difference was primarily due to a $17.6 million charge for delivery of narsoplimab drug substance and $1.9 million of costs related to the debt transaction. In addition, zaltenibart clinical research costs also increased but were offset by decreased clinical expenditures on narsoplimab due to the termination of our IgA nephropathy program.

Interest expense during the second quarter of 2024 was $9.2 million compared to $7.9 million during the prior year quarter. The increase was due to the additional $115.5 million of borrowing under the royalty obligation with DRI Healthcare Acquisitions LP in February 2024. These increases were partially offset by decreased interest upon retiring the 2023 convertible notes in November 2023 and repurchasing and retiring the majority of the 2026 Notes in December 2023 and June 2024.

During the second quarter of 2024, we earned $3.2 million in interest and other income compared to $4.5 million in the second quarter of 2023. The difference is primarily due to lesser cash and investments available to invest in the second quarter.

Net income from discontinued operations, net of tax, was $9.1 million, or $0.15 per share, in the second quarter of 2024 compared to $7.0 million, or $0.11 per share, in the second quarter of 2023. The increase was primarily attributable to increased non-cash interest earned on the OMIDRIA contract royalty asset and higher remeasurement adjustments in the current 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/BIcbf11bdb8ab84f58a90a501bd3a6beb9. 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, as well as 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, expectations regarding future cash expenditures, 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

 

 

Six Months Ended

 

 

June 30,

 

 

June 30,

 

 

2024

 

 

2023

 

 

2024

 

 

2023

 

 

 

 

 

 

 

 

 

Costs and expenses:

 

 

 

 

 

 

 

 

 

 

 

 

Research and development

 

$

45,349

 

 

$

29,639

 

 

$

72,119

 

 

$

54,249

 

Selling, general and administrative

 

 

13,808

 

 

 

11,260

 

 

 

26,072

 

 

 

22,363

 

Total costs and expenses

 

 

59,157

 

 

 

40,899

 

 

 

98,191

 

 

 

76,612

 

Loss from operations

 

 

(59,157

)

 

 

(40,899

)

 

 

(98,191

)

 

 

(76,612

)

Interest expense

 

 

(9,215

)

 

 

(7,932

)

 

 

(17,446

)

 

 

(15,865

)

Interest and other income

 

 

3,247

 

 

 

4,537

 

 

 

6,662

 

 

 

8,500

 

Net loss from continuing operations

 

 

(65,125

)

 

 

(44,294

)

 

 

(108,975

)

 

 

(83,977

)

Net income from discontinued operations, net of tax

 

 

9,084

 

 

 

7,000

 

 

 

15,760

 

 

 

12,982

 

Net loss

 

$

(56,041

)

 

$

(37,294

)

 

$

(93,225

)

 

$

(70,995

)

 

 

 

 

 

 

 

 

Basic and diluted net income (loss) per share:

 

 

 

 

 

 

 

 

Net loss from continuing operations

 

$

(1.12

)

 

$

(0.70

)

 

$

(1.87

)

 

$

(1.34

)

Net income from discontinued operations

 

 

0.15

 

 

 

0.11

 

 

 

0.27

 

 

 

0.21

 

Net loss

 

$

(0.97

)

 

$

(0.59

)

 

$

(1.60

)

 

$

(1.13

)

 

 

 

 

 

 

 

 

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

 

 

57,944,016

 

 

 

62,837,125

 

 

 

58,374,716

 

 

 

62,832,991

 

 

OMEROS CORPORATION

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEET

(In thousands)

 

June 30,

 

December 31,

 

2024

 

2023

Assets

 

 

Current assets:

 

 

Cash and cash equivalents

 

$

2,120

 

 

$

7,105

 

Short-term investments

 

 

156,792

 

 

 

164,743

 

OMIDRIA contract royalty asset, current

 

 

29,665

 

 

 

29,373

 

Receivables

 

 

8,080

 

 

 

8,096

 

Prepaid expense and other assets

 

 

6,273

 

 

 

8,581

 

Total current assets

 

 

202,930

 

 

 

217,898

 

OMIDRIA contract royalty asset, non-current

 

 

133,428

 

 

 

138,736

 

Right of use assets

 

 

16,868

 

 

 

18,631

 

Property and equipment, net

 

 

2,034

 

 

 

1,950

 

Restricted investments

 

 

1,054

 

 

 

1,054

 

Total assets

 

$

356,314

 

 

$

378,269

 

 

 

Liabilities and shareholders’ equity (deficit)

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

6,502

 

 

$

7,712

 

Accrued expenses

 

 

27,966

 

 

 

31,868

 

OMIDRIA royalty obligation, current

 

 

19,434

 

 

 

8,576

 

Lease liabilities, current

 

 

5,573

 

 

 

5,160

 

Total current liabilities

 

 

59,475

 

 

 

53,316

 

Convertible senior notes, net

 

 

96,888

 

 

 

213,155

 

Long-term debt, net

 

 

94,506

 

 

 

 

OMIDRIA royalty obligation

 

 

212,323

 

 

 

116,550

 

Lease liabilities, non-current

 

 

15,632

 

 

 

18,143

 

Other accrued liabilities, non-current

 

 

2,088

 

 

 

2,088

 

Shareholders’ equity (deficit):

 

 

 

 

 

 

Common stock and additional paid-in capital

 

 

722,157

 

 

 

728,547

 

Accumulated deficit

 

 

(846,755

)

 

 

(753,530

)

Total shareholders’ deficit

 

 

(124,598

)

 

 

(24,983

)

Total liabilities and shareholders’ equity (deficit)

 

$

356,314

 

 

$

378,269

 

 

Jennifer Cook Williams

Cook Williams Communications, Inc.

Investor and Media Relations

IR@omeros.com

Source: Omeros Corporation

FAQ

What was Omeros 's (OMER) net loss in Q2 2024?

Omeros reported a net loss of $56.0 million, or $0.97 per share, for Q2 2024.

How much cash and short-term investments did OMER have as of June 30, 2024?

Omeros had $158.9 million in cash and short-term investments as of June 30, 2024.

What was the amount of OMIDRIA royalties earned by OMER in Q2 2024?

Omeros earned $10.9 million in OMIDRIA royalties on $36.4 million U.S. net sales in Q2 2024.

What is the status of Omeros' (OMER) narsoplimab BLA for TA-TMA?

Omeros is in ongoing discussions with the FDA regarding the analysis plan and evidence for resubmission of the narsoplimab BLA for TA-TMA.

What clinical progress has OMER made with zaltenibart (OMS906) in Q2 2024?

Zaltenibart is advancing in Phase 2 trials for PNH, showing promising interim results, and is on track to initiate Phase 3 trials later in 2024.

Omeros Corporation

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