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Investor releaseQuarter not tagged2026-08-20Omeros (OMER) Q2 2026 Earnings Call Transcript
Motley Fool
Omeros (OMER) Q2 2026 Earnings Call Transcript
Image source: The Motley Fool. Wednesday, Aug. 12, 2026 at 4:30 p.m. ET Chairman and Chief Executive Officer - Gregory A. Demopulos Chief Accounting Officer - David J. Borges Chief Regulatory Officer - Catherine A. Melfi Vice President of Clinical - Steve Whitaker Chief Commercial Officer - Phil Woodman Investor Relations - Jennifer Williams President - David W. Ghesquiere Operator: Afternoon, and welcome to today's earnings call for Omeros Corporation. After the company's remarks, we will conduct a question and answer session. If you would like to ask a question, please raise your hand. If you have dialed into today's call, please press 9 to raise your hand and 6 to unmute. Please be advised that this call is being recorded at the company's request and a replay will be available on the company's website. I will now turn the call over to Jennifer Williams, Investor Relations for Omeros. Please go ahead. Gregory A. Demopulos: Thank you, and good afternoon, everyone. Before we begin, please note that today's discussion will include forward looking statements. These statements reflect management's current expectations and beliefs as of today and are subject to risks and uncertainties that could cause actual results to differ materially. For a detailed discussion of these risks and uncertainties, please refer to the special note regarding forward looking statements and the risk factors in our quarterly report on Form 10 Q filed today with the SEC as well as our most recent annual report on Form 10-K. Today's call also will include certain non GAAP financial measures. A reconciliation of these measures to the corresponding GAAP measures is included in Omeros' earnings release issued earlier today available on the Investor Relations page of our website and furnished with the form 8 k we filed today with the SEC. With that, I will turn the call over to Dr. Gregory Demopulos, Chairman and CEO of Omeros. Thank you, Jennifer, and good afternoon, everyone. Joining me today are David J. Borges, our chief accounting officer, Dr. Kathy Melfi, our chief regulatory officer, Dr. Steve Whitaker, vice president of clinical and Phil Woodman, our chief commercial officer. Promoted from within the company, Bill was recently appointed as our chief commercial officer and let me tell you a bit more about him. Bill joined Omeros 6 years ago as our vice president of sales and market d…Read full documentShow less
Image source: The Motley Fool. Wednesday, Aug. 12, 2026 at 4:30 p.m. ET Chairman and Chief Executive Officer - Gregory A. Demopulos Chief Accounting Officer - David J. Borges Chief Regulatory Officer - Catherine A. Melfi Vice President of Clinical - Steve Whitaker Chief Commercial Officer - Phil Woodman Investor Relations - Jennifer Williams President - David W. Ghesquiere Operator: Afternoon, and welcome to today's earnings call for Omeros Corporation. After the company's remarks, we will conduct a question and answer session. If you would like to ask a question, please raise your hand. If you have dialed into today's call, please press 9 to raise your hand and 6 to unmute. Please be advised that this call is being recorded at the company's request and a replay will be available on the company's website. I will now turn the call over to Jennifer Williams, Investor Relations for Omeros. Please go ahead. Gregory A. Demopulos: Thank you, and good afternoon, everyone. Before we begin, please note that today's discussion will include forward looking statements. These statements reflect management's current expectations and beliefs as of today and are subject to risks and uncertainties that could cause actual results to differ materially. For a detailed discussion of these risks and uncertainties, please refer to the special note regarding forward looking statements and the risk factors in our quarterly report on Form 10 Q filed today with the SEC as well as our most recent annual report on Form 10-K. Today's call also will include certain non GAAP financial measures. A reconciliation of these measures to the corresponding GAAP measures is included in Omeros' earnings release issued earlier today available on the Investor Relations page of our website and furnished with the form 8 k we filed today with the SEC. With that, I will turn the call over to Dr. Gregory Demopulos, Chairman and CEO of Omeros. Thank you, Jennifer, and good afternoon, everyone. Joining me today are David J. Borges, our chief accounting officer, Dr. Kathy Melfi, our chief regulatory officer, Dr. Steve Whitaker, vice president of clinical and Phil Woodman, our chief commercial officer. Promoted from within the company, Bill was recently appointed as our chief commercial officer and let me tell you a bit more about him. Bill joined Omeros 6 years ago as our vice president of sales and market development, bringing more than 25 years of industry experience, including sales and marketing leadership roles at Amgen, Spectrum Pharmaceuticals, and Jazz Pharmaceuticals. Where he led the global launch of defibrotide. Atomero's bill largely built our commercial team. And was instrumental in designing and executing the Yartemlia launch. I have long believed that Bill's background capabilities and achievements are ideally suited to Omeros' current and future objectives Under his leadership, our commercial team is driving Yartemlia toward becoming the standard of care for TA-TMA, and preparing for its expansion into a broad range of MASP 2 driven indications. Beyond complement, Bill's track record of driving growth across oncology, rare disease, and specialty biopharma products, will serve Omeros well. Before I turn to the financial details, let me highlight 3 points. First, Yartemlia generated $32.2 million in gross sales in its first full quarter on the market. Second, operations generated $4.1 million of positive cash flow during the quarter. And third, we meaningfully strengthened our capital structure through our share and note repurchases. So I will now begin with an overview of our second quarter operations and financial results followed by program updates. David will then review the financials in more detail, after which we will open the call for questions. As you know, the FDA approved Yartemlia, our lead MASP-2 inhibitor in December 2025 for the treatment of stem cell transplant associated thrombotic microangiopathy. Or TA-TMA. Yartemlia is the first and only approved treatment for this often fatal complication of stem cell transplantation and your Yartemlia is also the first and only approved inhibitor of the lectin pathway of complement. We launched Yartemlia in mid January, with initial distributor shipments beginning mid month and first sales following shortly thereafter. The second quarter was our first full quarter of Yartemlia sales, and we are pleased to share the results today. As I mentioned in the second quarter, Yartemlia generated $32.2 million in gross sales and $28.5 million in net sales. Reflecting strong physician adoption, and market penetration and a gross to net adjustment of 11.5%. Compared with the first quarter, gross sales increased 190% and net sales increased 188%. We will discuss the launch in more detail in just a bit. Net income for the second quarter was $200 thousand or $0.18 per share. As we have previously discussed our results include non cash mark to market adjustments related to the derivative embedded in our 2029 convertible notes. Excluding noncash remeasurements of embedded derivatives and other financial instruments. Second quarter non GAAP adjusted net income was $1.8 million or $0.02 net income per share. David will walk through the quarter over quarter comparisons and accounting detail shortly. We ended the quarter with $132 million in cash and investments, Importantly, company wide, operations provided net positive cash flow in the quarter of $4.1 million. Our share repurchases and sub subsequent note repurchases further strengthened our capital structure. During the 6 months ended June 30, we repurchased and retired approximately 843 thousand shares of Omeros common stock nearly 60% of those shares in the second quarter, at a volume weighted average price of $11.70 per share. Then in July through 2 privately negotiated transactions, we repurchased $30.5 million aggregate principal amount of our 9.5% convertible notes due in 2029. Reducing the outstanding principal by 43% to $40.3 million. The repurchases also reduced the number of shares issuable upon conversion from approximately 11.4 million to 6.5 million shares. We achieved this reduction at a weighted average cost of $12.21 per underlying conversion share and concurrently eliminated $8.6 million in future interest payments. Together, our open market share repurchases and our negotiated note repurchases have reduced our potential fully diluted share count by 5.8 million shares year to date. Turning back to Yartemlia, our launch remains focused on 4 priorities. 1, educating transplant teams to recognize and treat TA-TMA earlier. 2, securing institutional access through pharmacy and therapeutics or P&T committee approvals, and streamlined ordering. 3, ensuring timely reimbursement. And 4, demonstrating Yartemlia's economic value through health economics and outcomes research, or HEOR. Together, these priorities are intended to change how transplant centers approach TA-TMA. Historically, particularly at adult transplant centers, TATMA often has been treated as a diagnosis of exclusion. And considered only after other potential causes are ruled out. We are working to shift that paradigm toward proactive screening, enabling clinicians to identify and treat more patients earlier and ultimately improve transplant outcomes. Execution remains strong. Our field sales organization is actively engaging all 175 U.S. transplant centers. As of June 30, 73 unique accounts had ordered Yartemlia, a 143% increase since March 31. As discussed on our first quarter call, pediatric patients initially represented an outsized share of utilization. With rapid adoption at adult transplant centers, however, the mix has shifted significantly. In the second quarter, adult utilization grew at more than twice the rate of pediatric utilization. And adult patients represented approximately 75% of Yartemlia sales. This mix is closely approaching the historical 85%/15% split between adult and pediatric transplant procedures in The US. Formulary adoption. Also continues to progress rapidly. By quarter end, we understand that Yartemlia had received PNT committee approval at approximately 55% to 60% across the top 10. 2040, and 80 US transplant center cohorts that we track. Ordering frequency also increased meaningfully. Indicating deeper utilization within centers. We also achieved key reimbursement milestones during the quarter. The Centers for Medicare and Medicaid Services or CMS assigned Yartemlia a permanent product specific health care common procedure coding system or J-code effective July 1. The j code establishes a clear and consistent outpatient reimbursement pathway, reduces administrative burden, and supports more predictable payment for providers. CMS also recommended a new technology add on payment or NTAP for Yartemlia under the fiscal year 2027 proposed rule for the inpatient prospective payment system or IPPS and has now granted the NTAP in the final IPPS rule. The NTAP provides up to $287 thousand in additional Medicare reimbursement for inpatient treatment with Yartemlia. This is particularly important because Medicare beneficiaries represent approximately 30% of U.S. allogeneic transplant recipients. The NTAP for YARTEMLEA is expected to become effective October 1. Commercial payer experience also remains positive. Prior authorization requests are being approved consistently. And centers receiving appropriate payment reflect growing acceptance of Yartemlia among commercial insurers. We are preparing our HEOR analyses for presentation at upcoming scientific meetings, and for peer reviewed publication. We expect these analyses to further demonstrate Yartemlia's clinical and economic value and support continued adoption. Overall, early commercial indicators, strong transplant center engagement, continued formulary and ordering momentum, and payer alignment with the approved label reinforce our expectation that Yartemlia can become the standard of care for TA-TMA. Looking ahead, we continue to pursue expansion opportunities for Yartemlia, and our broader MASP 2 platform. In June, following an oral explanation before the European Medicines Agency's committee for medicinal products for human use or CHMP the committee adopted a negative opinion on our marketing authorization application for Yartemlia in TA-TMA. We believe the clinical evidence supports approval, and have requested reexamination. The application is supported by our Pivotal narsoplimab trial data in TA-TMA survival analyses comparing narsoplimab treated patients with an external registry of patients who did not receive narsoplimab and data from more than 220 adult and pediatric patients treated through our expanded access program. This same body of evidence supported Yartemlya's FDA approval. As part of the reexamination and hoc expert group or AHEG comprising independent external scientific and clinical experts in hematology, stem cell transplantation, and TA-TMA. We will review the evidence and address questions central to CHMP's assessment. The AHEG will hear from Omeros, and from transplant experts with direct experience using narsoplimab and new rapporteurs will review the application. We remain focused on obtaining approval in Europe Meanwhile, we continue to provide Yartemly a to European patients with TATMA through our expanded access program. Prioritizing children. We also continue to assess opportunities to expand the Yartemlia label. We are prioritizing indications with a strong biologic rationale for MASP 2 inhibition. Particularly those involving endothelial injury, lectin pathway activation, and thrombo inflammation. These encompass an extensive list of indications, including chemotherapy-induced TA, acute respiratory distress syndrome or ARDS, and other transplant related endothelial injury syndromes. We plan to evaluate new indications through preclinical research, investigator initiated studies, and clinical trials each as appropriate. By year end, we expect enrollment to begin in 2 investigator sponsored and Omeros supported studies, 1 evaluating Yartemlia in hyperinflammatory ARDS, and the other assessing prophylactic Yartemlia in pediatric patients with predictably severe TA-TMA. Our MASP 2 platform extends beyond Yartemlia. We are advancing our phase 2 ready long acting MASP 2 antibody OMS1.03 thousand and an oral small molecule MASP 2 inhibitor program. Both are designed for chronic indications requiring long term administration. Including membranous nephropathy and neurodegenerative diseases such as Parkinson's, and Alzheimer's. In Phase 1 clinical trials, OMS1.03 thousand showed the clear ability to inhibit MASP 2 over an extended duration with once-quarterly subcutaneous or intravenous dosing. And our small molecule MASP-2 inhibitor is targeting once-daily oral dosing. We are finalizing the initial Phase 2 indication for OMS1.03 thousand. Clinical drug product and matching placebo, have been manufactured and are available. For our MASP-2 small molecule program, we have 1 ongoing study to complete. After which we expect to select an orally delivered development candidate. For that program. Our collaboration with Novo Nordisk also continues to progress smoothly. The Novo transaction provides up to $2.1 billion in upfront and milestone payments. Plus royalties ranging from high-single digits to the high-teens. At closing in the fourth quarter of 25, we received $240 million in upfront cash, which funded the Yartemlia launch and other operations. We also are eligible to receive up to an additional $100 million in near term milestone payments. Our interactions with Novo remain collaborative, and productive, and we continue to provide transition services at Novo's cost. Turning now to development programs beyond our complement inhibitor franchise, our PDE7 inhibitor program evaluating OMS527 for cocaine use disorder. Remains fully funded by a grant from the National Institute on Drug Abuse, or NIDA. Earlier this year, we met with FDA regarding the agency's request for additional nonclinical information before initiating the inpatient study. That nonclinical work has initiated, and we expect to start enrollment in the inpatient clinical trial by year end. Based on its mechanism of action and our extensive preclinical data, we believe that OMS 27 could be effective across a broad range of addiction, and compulsive disorders. Our targeted complement activating therapy or TCAT platform is a novel class of recombinant antibodies designed to target and directly kill pathogens, including bacteria, fungi, viruses, and parasites. Our initial focus is on infections caused by multidrug resistant organisms, among medicines most critical unmet needs. Unlike antimicrobial agents on the market, TCAT is designed to kill pathogens regardless of resistance profile, and without promoting or enhancing resistance. The foundational manuscript describing our T-CAT technology was published in Science Translational Medicine in June of this year. The manuscript details the technology and demonstrates that TCAP monoclonal antibodies safely and effectively treated infections in translationally relevant murine models of sepsis and pneumonia caused by multiple different drug resistant bacterial species prioritized by the World Health Organization as posing the greatest threat to human health. The data underscore TCAT's potential as a next generation platform with broad applicability across microbial species, including multidrug resistant pathogens. And we look forward to advancing TCAT toward the clinic. Finally, OncotoX-AML, or OMS805, is the lead program in our oncology platform. it is an engineered biologic designed to treat acute myeloid leukemia or AML, the most common and 1 of the deadliest acute leukemias in adults. Across tumor bearing animal models and in vitro human AML cell line studies. OncotoX-AML, has consistently demonstrated efficacy superior to current standards of care. Even at very low doses. Importantly, this efficacy was independent of AML related mutations, including TP53 and FLT3, which historically have been very difficult to treat. In a nonhuman primate study, a single course of OncotoX-AML produced the desired pharmacologic response, a marked selective reversible and dose related reduction. In myeloid progenitor cells by up to 99%. Treatment was well tolerated, with no safety signal of concern. We have entered into agreement with a leading contract biologics manufacturer for process development and clinical supply of OMS805 drug substance. IND enabling studies are underway. Given the novelty of the OncotoX program, its potential applicability across hematologic malignancies, and the breadth of our unpublished data and pending patent claims, we plan to limit further public disclosure until OMS805 enters human studies, and begins generating clinical data. Working with our advisory board of leading AML experts. We are preparing for a first in human trial targeted to begin in late 2027. So that concludes our corporate and program update. I will now turn the call over to David for a more detailed review of our financial results. David? David J. Borges: Thanks, Craig. Our second quarter results reflect continued focus on commercial execution of the Yartemlia launch and actions to strengthen our capital structure. Net income for the second quarter of 26 was 13.2 million or $0.18 per share compared with net income of $56.1 million or $0.78 per share in the first quarter of 26. Second quarter results included a $12.1 million noncash mark to market gain on the embedded derivative associated with our 2029 convertible notes. And a $700 thousand remeasurement loss on our payment obligation for the 2029 note repurchases. By comparison, first quarter results included a $73.1 million non-cash mark to market gain on the embedded derivative associated with the 2029 convertible notes. To provide additional visibility into our operating performance, we also present non GAAP adjusted results that exclude non cash remeasurements of embedded derivatives and other financial instruments. Excluding these non cash re measurements, non GAAP adjusted net income for the second quarter was $1.8 million or $0.02 net income per share compared with a non GAAP adjusted net loss of $17.1 million or $0.24 net loss per share for the first quarter. As of June 30, 2026, we had $132 million in cash and investments and company wide net cash provided by operations in the second quarter was $4.1 million During the second quarter, we repurchased and retired approximately 489 thousand shares of our common stock at an average price of $11.70 per share for a total of $5.7 million. Through June 30, 2026, we had repurchased and retired approximately 843 thousand shares at the same average price for a total of $9.9 million In June and July 2026, we entered into agreements for 2 privately negotiated cash repurchases totaling $30.5 million aggregate principal amount of our 2029 convertible notes. Both transactions closed in July reducing our outstanding debt which consists solely of the 2029 notes by approximately 43%. from $70.8 million to $40.3 million. The aggregate purchase price was $60.2 million plus $200 thousand of accrued and unpaid interest. These transactions reduced leverage future cash interest expense, and potential dilution by opportunistically repurchasing and retiring a portion of the 2029 convertible notes. They also reduced the number of shares issuable on conversion from 11.4 million to 6.5 million. As Greg noted, Yartemlia maintained strong commercial momentum in the second quarter, Gross product revenues were $32.2 million, all from Yartemlia sales compared with $11.1 million in the first quarter and net revenues were $28.5 million, compared with $9.9 million in the first quarter. Gross to net adjustments were approximately 11.5% compared with approximately 11% in the first quarter and remained within our expectations. These adjustments consisted primarily of chargebacks and distribution fees. Costs and expenses from continuing operations, before interest and other income were $28.5 million, an increase of $1.1 million from the first quarter. Under the transition services entered into in connection with the zaltinibart transaction, we continue to be reimbursed for cost incurred in providing transition services. Including third party expenses and internal personnel cost. We also recognized $3.3 million of reimbursement from Novo Nordisk for zaltinibart inventory transfer during the quarter. Which we recorded in other income Interest expense was $7.6 million The primary components were the DRI royalty obligation, and interest on the 2029 convertible notes. Excluding the OMIDRIA royalty obligations to DRI, which is fully offset by amounts received from Raynor and therefore has no economic impact on Omeros. And non amortization of debt issuance costs and discounts contractual cash interest expense was $1.7 million, down $100 thousand from the first quarter. Interest and other income totaled $4.6 million in the second quarter, compared with $1.5 million in the first quarter. The increase was primarily attributable to the Novo Nordisk inventory reimbursement. As previously noted, we recorded a $12.1 million noncash mark to market gain on the embedded derivative related to our 2029 convertible notes. The change was driven primarily by the decline in our stock price from $10.56 per share at March 31 to $9.51 per share at June 30. Because the derivatives value is closely tied to our stock price, increases in our share price generally produce non cash losses while decreases generally produce non cash gains. This adjustment does not affect our operating performance or liquidity and is excluded from our non GAAP adjusted results. Following the July note repurchases, future mark to market adjustments will reflect the reduced principal balance. In connection with the June agreement to repurchase the first tranche of our 2029 convertible notes, comprising $16 million principal amount We recorded a $1.9 million loss The loss reflects the difference between the fair value of the payment obligation the carrying amount of the repurchase notes net of unamortized discounts and issuance cost, and the derecognition of the associated embedded derivative liability. Because the agreements for the second tranche comprising $14.5 million principal amount were entered into in July 2026 The related accounting will be reflected in our third quarter results. Income from discontinued operations in the second quarter was $6.6 million, up $1.8 million from the first quarter primarily due to a lower remeasurement adjustment. Because U.S. and Omidria royalties passed directly to DRI, fluctuations in these payments do not affect our cash position. Now let me turn to our expectations for the third quarter of 26. We expect total operating expenses from continuing operations to be slightly higher than in the second quarter. Research and development expenses are expected to increase primarily due to increased spending on our OMS805 OncotoX program sales and marketing expenses, are also expected to increase, reflecting continued investment in Yartemlia commercial infrastructure, marketing, and launch activities. Although we are encouraged by Yartemlia's continued commercial momentum, we are not providing revenue guidance at this time We believe it is prudent to gain additional experience with prescribing trends patient demand, and market dynamics. We remain focused on expanding physician awareness and disease education and ensuring continued timely reimbursement Interest and other income are expected to be lower in the third quarter primarily because the Novo Nordisk inventory reimbursement recognized in the second quarter will not recur Interest expense is expected to be approximately $6.5 million reflecting the reduction in the outstanding debt following the repurchases. This estimate excludes potential non cash adjustments related to the OMIDRIA royalty obligation. Income from discontinued operations, is expected to be between $5 million and $6 million again excluding any remeasurement adjustments related to the OMIDRIA contact contract royalty asset. And finally, as a reminder, our reported results will continue to reflect mark to market adjustments on the embedded derivative relating to our remaining 2029 convertible notes. These adjustments are noncash, They can be volatile, and are driven largely by stock price and other market inputs. We therefore present non GAAP adjusted net income and loss to provide additional visibility into underlying operating performance. And with that, I will turn the call back over to Greg. Gregory A. Demopulos: Gregory? Thanks, David. Operator, please open the call to questions. Operator: We will now begin the question and answer session. If you would like to ask a question, please raise your hand now. The raise hand button can be found in the center of the toolbar at the bottom of your screen on Zoom desktop and on the left side of the toolbar on Zoom mobile. If you have dialed in to today's call, please press 9 to raise your hand and 6 to unmute. Your first question comes from the line of Brandon Folkes with H. C. Wainwright. Your line is open. Please go ahead. Brandon Folkes: Hi, thanks for taking my questions and congrats on a very good quarter. Maybe just 2 from me. I guess, firstly, with the AstraZeneca Ultomiris data release are you having any updated conversations around C5 use at all? Obviously, it is off label. Right? But, you know, I guess any color in terms of why a transplant center would still use the C5 at all for these TA-TMA patients. And then secondly, obviously, very big quarter here. Congrats on that. You know, meaningfully ahead of a lot of forecasts. So wanted to see if you could just try put this in perspective relative to your internal forecasts especially the company wide cash flow forecast you put out earlier, and then along those lines, do you still expect month to month variability as you called out at your AGM? Thank you. Gregory A. Demopulos: Thanks, Brandon. With respect to the first question regarding C5 inhibition. As you noted, rabulizumab previously missed the endpoint on its open label pediatric study, And then recently, reported that it as well had missed the endpoint on its controlled adult trial. So as far as we all understand and you understand, they did not meet their endpoints across any of the ravulizumab TATMA trials. Your question as to whether there remains off label primarily eculizumab, use, because the dosing, frankly, for ravulizumab is not really conducive to the acute indication of t a t m a. Eculizumab is more frequently dosed shorter half life. There is some continued eculizumab off label use. We do not really know how much. We do not frankly focus. On how much I will ask Bill to speak to that and his thoughts around the competition there which I will I will preempt a bit by saying we do not really see it as competition for Yartemlia. I think with respect to why there might be continued use for a while of eculizumab, I think certainly, it is hard to break old habits. Among physicians, and that is likely what we are seeing. But when you look at the adoption of narsoplimab, the breadth of the adoption, the depth of the adoption, I think that speaks volumes. About how physicians see our drug, I also think certainly the safety profile. I mean, let's put aside the efficacy, which we are very pleased with the efficacy that we are seeing with narsoplimab in the commercial setting. But let's look at the safety issues. I mean, narsoplimab is not associated with the same issues as C5 inhibition. it is just it is a biological fact when you inhibit c 5, you inhibit the lytic arm of the classical pathway that increases the risk of infection. Inhibition of NARSOP of MASP 2 with narsoplimab or Eartemlia is upstream. So we are inhibiting the lectin pathway at really the near the top of the lectin pathway. And by doing so, we maintain that adaptive immune response. So with respect to why folks would physicians would continue for a while to use eculizumab I think the best answer to that is 1 of habit and just perhaps not fully understanding the benefits yet that YARTEMLEA brings. But I frankly expect that will not be a long lived challenge for us. But Bill, let me ask you. To comment on that Sure. David W. Ghesquiere: Thanks, Gregory. Yeah. I totally agree. Know, physicians are humans too, and humans generally do not welcome change with open arms. Eglisumab was their only option for 10 or 12 or 15 years. And in peds, it was widely adopted. Adults, not so much. But in peds even in peds, we are seeing adoption across centers use in both first and second line. Adults, it is pretty much first line. So we expect this to be a temporary hiccup to our goal of being really the best in class first line therapy for TATMA in both adult and pediatric centers. Gregory A. Demopulos: Thank you, Bill. Brandon, your next question was how our internal forecasts, I believe, compare to what we have seen We will not comment today on our internal or external. Forecast. We will not guide the other part of that question, I think, though, was around our cash flow forecast. Certainly, we hold to our statement previously that by mid 27, we expect to be cash flow positive company wide. And in fact, you saw the result we generated this quarter from operations, 4.1 million of net positive cash. So I think we are quite comfortable holding to that prediction. David, any comments on that? David J. Borges: No. I would say that states it really well, and I agree with what you just said, Gregory. Gregory A. Demopulos: Thank you. Anything else, Brandon? Brandon Folkes: Nope. Other than to say congrats on a really good quarter, and a good launch. Thanks, Brandon. Gregory A. Demopulos: Thank you very much. Operator: Your next question comes from the line of Steve Brozak with WBB. Your line is open. Please go ahead. Stephen Brozak: Yes. Hey. Good afternoon, Gregory, and obviously, thank you for taking these questions, and congrats on these numbers. I am thrilled, and I am sure the patient is being treated with Yartemlia are also thrilled. Financial questions. Can you just iterate are any of these numbers from any kind of channel stocking or do they represent pure numbers? For drug going out? And I have got a follow-up after that, please. Gregory A. Demopulos: Sure. Thanks, Steve. An answer to that first question no. Categorically, no. This drug is available to patients when from the wholesaler or distributor. To the medical centers within 24 hours. So there really is no incentive or rationale to stock or stuff the channel. And frankly, we have seen inventories at about 1.5 weeks of supply, and that has been consistent since Q1. Really, since the very first quarter, it is been quite consistent at about 1.5 weeks. Of supply held by the distributors. So the answer to your question is really no. These are, as you put it, I will use your term, these are pure numbers. Stephen Brozak: Okay. Thank you. Last question, and I will jump back in the queue. NTAPs. Okay? I have been familiar with different NTAPs programs, but your numbers are obviously much, much higher. Can you tell us in terms of reimbursement, can you tell us the NTAP process and how you are set up for that because that is something that not that many people are familiar with. And I will hop back in the queue. Thank you. Gregory A. Demopulos: Sure. NTAP is a CMS program. That, frankly, subsidizes the cost of new drugs entering the market while that period of time occurs over which the DRGs are adjusted to account for those new drugs. So as you know, CMS has set an amount up to 287 thousand for a course of treatment for Yartemlia. We are quite pleased with that. it is at that roughly 65% cap that CMS will allow. CMS, as you saw, in there, proposed IPPS rule recommended the NTAP for Yartemlia and subsequently, in the final rule, confirmed it. So I think they recognize the utility and the importance of the drug and we are quite pleased that becomes effective or is scheduled to become effective on October 1. Kathy, do you wanna add anything else? Catherine A. Melfi: Yeah. No. I think, Gregory, you explained it well. I mean, it as you know, the reimbursement for these DRGs you know, does not account for the new technology. And so with the approval of Yartemlia, and its use in this condition, CMS has to add this on. And so again, we submitted the application. Proposed the add on payment, and we are pleased with the result that we got in terms of they will be including for the use of Yartemlia. Gregory A. Demopulos: Thank you. Stephen Brozak: Steve, did that answer you? Perfectly on both counts. Thank you. And again, congrats on these on these strong, strong numbers. Gregory A. Demopulos: Yes. Thank you. We are all pleased, and we look forward to the continued growth Your next question comes from the line of Samuel Rodriguez Santiago with Cantor Fitzgerald. Operator: Your line is open. Please go ahead. Samuel Rodriguez: Hey. This is Samuel on for Olivia. Quick question. Since you mentioned the adults are making up 75% of the orders now, have you seen a difference in the amount of vials used per patient? Gregory A. Demopulos: To I think our collective knowledge, no. We do not really have great visibility into vial utilization at specific centers, as you understand, with all of the HIPAA and confidentiality issues around patient information We just do not get that information. But certainly, the ordering patterns are consistent across the pediatric and the adult centers. So I think my answer to that would be no, but let me ask Bill again who may have information that I do not have. David W. Ghesquiere: No. They are not significantly different between the 2. You know, when you launch, a new product into a deadly disease that you generally tend to get very severe patients at the beginning. So you may need to see a little bit more drug at the beginning. Because they are they tend to require more medication. And I do not think this is not different between peds and adults. Over time, we expect to treat a lot more patients, with fewer vials as they start to get better at diagnosing and treating it early, and getting better outcomes. So that is really kind of the way we expected to go. In the future. Gregory A. Demopulos: And moving the treatment setting more toward the outpatient. Right, Bill? And less so in the inpatient so that the response remember, in the absence of a really effective and safe drug, They focus on earlier and earlier treatment has not been there. In fact, the focus has been how can we get these patients better without having to use some treatment for those patients. I think as we spoke about during the prepared comments, we are seeing and we are certainly helping, I think, to implement a paradigm shift to earlier and earlier utilization for increasingly improved outcomes. The sooner you get to these patients, the harder you hit them with Yartemlia I think the data clearly support the better. They will do. Samuel Rodriguez: Awesome. Thank you, and congrats on the quarter. Gregory A. Demopulos: Thank you, Samuel. Operator: Your next question comes from the line of Serge Belanger with Needham. Your line is open. Please go ahead. Serge Belanger: Hi. Good afternoon, and thanks for taking my questions. First, on Yartemlia, Gregory, can you just talk about maybe the number of patients that have so far been treated with the product and I guess, what the kind of the market share of the overall opportunity would be based on those patients. And then secondly, you talked about in your prepared comments that TATMA is mostly a diagnosis of exclusion. So with the shift paradigm that you are working on, what do you expect market opportunity could be? Or what is the underdiagnosis and undertreated rate for, the indication? Thank you. Gregory A. Demopulos: Sure, Serge. Thanks for the questions. First, we cannot give you any really definitive numbers on patient use because we do not have patient numbers. We see vials. We see vials that go into a center We do not have any data beyond that, really. Other than occasional anecdotal data that we may receive. But we have no way of determining how many patients are being treated with those vials, where in the treatment course those patients are, etcetera. So with respect to patient numbers, cannot really provide that information. With respect to the prepared comment about diagnosis of exclusion, I think what clearly is meant there is prior to an approved product, prior to Yartemlia, being available the diagnosis of TA-TMA was quite challenging and really very diverse across centers. So different sets of criteria being used, by different centers, by different physicians, a lack of real standardization of the diagnostic criteria, So absent a really good treatment for TA-TMA, you can understand why physicians would look at a constellation of symptoms and say, let's rule out those things that we know we can treat And if we cannot treat those, then this is going to fall to what we will call TA-TMA. We do believe that we are simply now scratching the surface. Again, I will look to Bill to comment on that in just a moment. But I think our collective view on this is we are just scratching the surface. And as there becomes further embedded an effective and a safe treatment for TATMA the diagnosis of TATMA accordingly will increase. And I think that the overall incidence numbers are going to continue to move north, I think the percentage of patients who ultimately end up being diagnosed with TATMA as a percentage of stem cell transplantation will also increase. We are already seeing it. The latest Midas studies shows the incidence of TA-TMA at 56 percent of allogeneic transplant. And I would think that there is a reasonable possibility that those percentages will increase. Again, when you have a treatment, there is a good reason to identify. The disorder and then the treatment becomes self fulfilling, for that set of diagnostic criteria. But, again, let me turn this to Bill and see Bill, what are your thoughts on this? David W. Ghesquiere: Yeah. I mean, I totally agree, Gregory. We are just scratching the surface. You know, as well as we have done so far, we expect to do better in the future. It Institutional organizations, large academic centers, it is very hard to get real change in a in an institutional center. Not because they do not want to, just because they are a huge organization. there is a lot of levers to push in order to really change the way they look at things. Not just P&T committees, but order sets and EMRs, the way that they diagnose TMA, and that fundamentally has to change. We have made that change in some centers, but we have a lot more to go and we think it will get better over time. You know, pretty consistently over time. Gregory A. Demopulos: Great. Thank you. Operator: There are no further questions at this time. I will now turn the call back to Dr. Demopulos for closing remarks. Gregory A. Demopulos: Thank you, operator, and again, thank you all for joining us this afternoon. As we enter the second half of the year, Yartemlia has demonstrated strong commercial momentum. In its first full quarter on the market. Reimbursement infrastructure continues to strengthen Our operations generated positive cash flow in the quarter, and our recent note repurchases reduced debt and reduced potential dilution. We remain focused on execution, driving Yartemlia adoption in TA-TMA, advancing expansion opportunities across the MASP 2 franchise, and moving our other programs across our deep pipeline forward. We have a number of important opportunities and milestones ahead, and we look forward to updating you on our progress. Have a good evening. Thank you. Operator: This concludes today's call. Thank you for attending. You may now disconnect. Before you buy stock in Omeros, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Omeros wasn’t one of them. The 10 stocks that made the cut are built for long-term growth and could produce monster returns in the coming years. Consider when Netflix made this list on December 17, 2004... if you invested $1,000 at the time of our recommendation, you’d have $419,408!* Or when Nvidia made this list on April 15, 2005... if you invested $1,000 at the time of our recommendation, you’d have $1,348,694!* That performance is why people listen. With a track record of beating the S&P 500 by nearly 5x, Stock Advisor offers a distinct advantage. Don't miss the latest top 10 list, available with Stock Advisor, and join an investing community built for the long haul. See the 10 stocks » *Stock Advisor returns as of August 19, 2026. This article is a transcript of this conference call produced for The Motley Fool. While we strive for our Foolish Best, there may be errors, omissions, or inaccuracies in this transcript. As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Omeros (OMER) Q2 2026 Earnings Call Transcript was originally published by The Motley Fool
Investor releaseQuarter not tagged2026-08-13Omeros Q2 Earnings Call Highlights
MarketBeat
Omeros Q2 Earnings Call Highlights
Interested in Omeros Corporation? Here are five stocks we like better. YARTEMLEA sales surged in its first full quarter, reaching $28.5 million in net sales, up 188% sequentially. Adoption expanded to 73 ordering accounts, while CMS reimbursement support includes a permanent J-code and potential NTAP payments of up to $287,000 per inpatient treatment. Omeros generated $4.1 million in operating cash flow and ended June with $132 million in cash and investments. The company also repurchased $30.5 million of 2029 convertible notes, cutting outstanding principal by approximately 43% and reducing potential dilution. The company is not providing revenue guidance and expects slightly higher third-quarter operating expenses. In Europe, regulators issued a negative opinion on YARTEMLEA, but Omeros requested re-examination while continuing to advance additional complement, oncology and CNS pipeline programs. Breakout Momentum Plays You Need to Know About Omeros (NASDAQ:OMER) reported second-quarter net sales of $28.5 million for YARTEMLEA, its newly launched treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA, as the company generated positive operating cash flow and reduced its convertible debt after the quarter ended. YARTEMLEA produced $32.2 million in gross sales during the quarter, its first full quarter on the market, and $28.5 million in net sales after gross-to-net adjustments of 11.5%. Gross sales rose 190% from the first quarter, while net sales increased 188%. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat The FDA approved YARTEMLEA in December 2025 for TA-TMA, a potentially fatal complication of stem cell transplantation. Omeros launched the product in mid-January. Chairman and CEO Gregory Demopulos said the product is the first approved treatment for TA-TMA and the first approved inhibitor of the lectin pathway of complement. Omeros said its sales organization is engaging all 175 U.S. transplant centers. As of June 30, 73 unique accounts had ordered YARTEMLEA, up 143% from March 31. Adult patients accounted for approximately 75% of second-quarter YARTEMLEA sales as use at adult transplant centers grew at more than twice the rate of pediatric utilization. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be The company said YARTEMLEA had received Pharmacy and Therapeutics co…Read full documentShow less
Interested in Omeros Corporation? Here are five stocks we like better. YARTEMLEA sales surged in its first full quarter, reaching $28.5 million in net sales, up 188% sequentially. Adoption expanded to 73 ordering accounts, while CMS reimbursement support includes a permanent J-code and potential NTAP payments of up to $287,000 per inpatient treatment. Omeros generated $4.1 million in operating cash flow and ended June with $132 million in cash and investments. The company also repurchased $30.5 million of 2029 convertible notes, cutting outstanding principal by approximately 43% and reducing potential dilution. The company is not providing revenue guidance and expects slightly higher third-quarter operating expenses. In Europe, regulators issued a negative opinion on YARTEMLEA, but Omeros requested re-examination while continuing to advance additional complement, oncology and CNS pipeline programs. Breakout Momentum Plays You Need to Know About Omeros (NASDAQ:OMER) reported second-quarter net sales of $28.5 million for YARTEMLEA, its newly launched treatment for hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA, as the company generated positive operating cash flow and reduced its convertible debt after the quarter ended. YARTEMLEA produced $32.2 million in gross sales during the quarter, its first full quarter on the market, and $28.5 million in net sales after gross-to-net adjustments of 11.5%. Gross sales rose 190% from the first quarter, while net sales increased 188%. → SoundHound AI Sends a Loud Signal After Its Q2 Earnings Beat The FDA approved YARTEMLEA in December 2025 for TA-TMA, a potentially fatal complication of stem cell transplantation. Omeros launched the product in mid-January. Chairman and CEO Gregory Demopulos said the product is the first approved treatment for TA-TMA and the first approved inhibitor of the lectin pathway of complement. Omeros said its sales organization is engaging all 175 U.S. transplant centers. As of June 30, 73 unique accounts had ordered YARTEMLEA, up 143% from March 31. Adult patients accounted for approximately 75% of second-quarter YARTEMLEA sales as use at adult transplant centers grew at more than twice the rate of pediatric utilization. → AST SpaceMobile Earnings Just Reminded Investors How Risky Space Can Be The company said YARTEMLEA had received Pharmacy and Therapeutics committee approval at approximately 55% to 60% of the top 10, 20, 40 and 80 U.S. transplant-center cohorts it tracks. Omeros also reported that ordering frequency increased during the quarter. On the reimbursement front, the Centers for Medicare & Medicaid Services assigned YARTEMLEA a permanent product-specific HCPCS J-code effective July 1. CMS also granted a new technology add-on payment, or NTAP, for the drug in its final fiscal 2027 inpatient prospective payment system rule. The NTAP, expected to take effect Oct. 1, provides up to $287,000 in additional Medicare reimbursement for inpatient treatment with YARTEMLEA. → First Solar’s Profit Engine Faces a New Policy Test in Washington Demopulos said Medicare beneficiaries represent about 30% of U.S. allogeneic transplant recipients. The company added that commercial prior authorization requests have been approved consistently and that it is preparing health economics and outcomes research analyses for scientific meetings and peer-reviewed publication. During the question-and-answer session, Demopulos said distributor inventory has remained at about 1.5 weeks of supply since the first quarter and said second-quarter sales did not reflect channel stocking. Chief Commercial Officer Bill Woodman said Omeros expects use to shift toward earlier diagnosis and treatment over time, potentially allowing treatment before patients become severely ill. Omeros reported second-quarter net income of $13.2 million, or $0.18 per share, compared with net income of $56.1 million, or $0.78 per share, in the first quarter. The results included a $12.1 million non-cash mark-to-market gain on the embedded derivative associated with the company’s 2029 convertible notes. Excluding non-cash remeasurements of embedded derivatives and other financial instruments, non-GAAP adjusted net income was $1.8 million, or $0.02 per share, compared with a non-GAAP adjusted net loss of $17.1 million, or $0.24 per share, in the first quarter. The company ended June with $132 million in cash and investments and generated $4.1 million in net cash from operations during the quarter. David Borges, Omeros’ chief accounting officer, said total operating expenses from continuing operations before interest and other income were $28.5 million, up $1.1 million sequentially. Omeros repurchased and retired approximately 489,000 common shares during the second quarter for $5.7 million, at an average price of $11.70 per share. Through June 30, the company had repurchased about 843,000 shares for $9.9 million. In June and July, Omeros entered agreements to repurchase $30.5 million aggregate principal amount of its 9.5% convertible notes due in 2029. The transactions closed in July for an aggregate purchase price of $60.2 million plus accrued interest, reducing outstanding principal by about 43%, from $70.8 million to $40.3 million. The repurchases also reduced shares issuable upon conversion from about 11.4 million to 6.5 million. For the third quarter, Borges said operating expenses are expected to be slightly higher than the second quarter, driven by increased spending on the OMS805 oncology program and continued investment in YARTEMLEA commercial activities. Omeros is not providing revenue guidance, citing the need for additional experience with prescribing trends, patient demand and market dynamics. In Europe, Omeros said the European Medicines Agency’s Committee for Medicinal Products for Human Use adopted a negative opinion in June on the company’s marketing authorization application for YARTEMLEA in TA-TMA. Omeros has requested a re-examination of the application. The review will include an Ad Hoc Expert Group of external specialists and new rapporteurs. The company said it continues to provide YARTEMLEA to European patients through an expanded access program, prioritizing children. It also plans to begin enrollment by year-end in two investigator-sponsored, Omeros-supported studies: one in hyperinflammatory acute respiratory distress syndrome and another evaluating prophylactic use in pediatric patients with predictably severe TA-TMA. Beyond YARTEMLEA, Omeros is advancing OMS1029, a long-acting MASP-2 antibody that is phase II-ready, and an oral small-molecule MASP-2 inhibitor program. The company is also conducting non-clinical work for OMS527, its PDE7 inhibitor for cocaine use disorder, and expects to begin enrollment in an inpatient clinical study by year-end. Omeros said it is preparing a first-in-human study of OMS805, also called OncotoX-AML, for late 2027. The engineered biologic is being developed for acute myeloid leukemia, and IND-enabling studies are underway. Omeros Corporation is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of small-molecule and protein therapeutics. The company's research programs target inflammation, complement-mediated diseases and disorders of the central nervous system. Omeros's portfolio encompasses both internally discovered molecules and biologics, reflecting its commitment to advancing treatments for conditions with high unmet medical need. Omeros's first FDA-approved product, Omidria® (phenylephrine and ketorolac intraocular solution), is indicated to maintain pupil size by preventing intraoperative miosis and reducing postoperative pain in patients undergoing cataract surgery. This instant news alert was generated by narrative science technology and financial data from MarketBeat in order to provide readers with the fastest reporting and unbiased coverage. Please send any questions or comments about this story to [email protected]. The article "Omeros Q2 Earnings Call Highlights" was originally published by MarketBeat. View MarketBeat's top stocks for August 2026.
Investor releaseQuarter not tagged2026-08-13Omeros Corporation Q2 2026 Earnings Call Summary
Moby
Omeros Corporation Q2 2026 Earnings Call Summary
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Yartemlia's first full quarter performance was driven by a significant shift toward adult transplant centers, which now represent approximately 75% of sales compared to initial pediatric-heavy utilization. Management is actively working to transition the clinical paradigm from treating TA-TMA as a 'diagnosis of exclusion' to proactive screening, which is expected to increase the identified patient population. The company achieved positive operational cash flow of $4.1 million, supported by strong net sales growth of 188% quarter-over-quarter and disciplined commercial execution. Strategic capital restructuring through share and note repurchases reduced the potential fully diluted share count by 5.8 million shares and eliminated $8.6 million in future interest payments. Market penetration is accelerating with 73 unique accounts ordering as of June 30, representing a 143% increase since the end of the first quarter. The launch strategy focuses on securing institutional access, with formulary approval already reached at approximately 55% to 60% of tracked top-tier U.S. transplant centers. Management reaffirmed expectations to be company-wide cash flow positive by mid-2027, supported by current commercial momentum and the Novo Nordisk milestone structure. The company is pursuing a re-examination of the European marketing authorization for Yartemlia following a negative CHMP opinion, utilizing an independent expert group to review pivotal data. Pipeline expansion plans include initiating two investigator-sponsored studies by year-end for hyperinflammatory ARDS and prophylactic use in pediatric TA-TMA. Development of the MASP-2 platform continues with the finalization of Phase 2 indications for the long-acting antibody OMS1030 and candidate selection for the oral small molecule program. Revenue guidance remains withheld as management seeks more experience with prescribing trends, patient demand, and the impact of upcoming reimbursement milestones. A permanent J-code became effective July 1, and a New Technology Add-on Payment (NTAP) providing up to $287,000 in additional reimbursement is scheduled for October 1. The company recorded a $12.1 million non-cash mark-to-market gain on embedded derivatives, a volatile f…Read full documentShow less
Our analysts just identified a stock with the potential to be the next Nvidia. Tell us how you invest and we'll show you why it's our #1 pick. Tap here. Yartemlia's first full quarter performance was driven by a significant shift toward adult transplant centers, which now represent approximately 75% of sales compared to initial pediatric-heavy utilization. Management is actively working to transition the clinical paradigm from treating TA-TMA as a 'diagnosis of exclusion' to proactive screening, which is expected to increase the identified patient population. The company achieved positive operational cash flow of $4.1 million, supported by strong net sales growth of 188% quarter-over-quarter and disciplined commercial execution. Strategic capital restructuring through share and note repurchases reduced the potential fully diluted share count by 5.8 million shares and eliminated $8.6 million in future interest payments. Market penetration is accelerating with 73 unique accounts ordering as of June 30, representing a 143% increase since the end of the first quarter. The launch strategy focuses on securing institutional access, with formulary approval already reached at approximately 55% to 60% of tracked top-tier U.S. transplant centers. Management reaffirmed expectations to be company-wide cash flow positive by mid-2027, supported by current commercial momentum and the Novo Nordisk milestone structure. The company is pursuing a re-examination of the European marketing authorization for Yartemlia following a negative CHMP opinion, utilizing an independent expert group to review pivotal data. Pipeline expansion plans include initiating two investigator-sponsored studies by year-end for hyperinflammatory ARDS and prophylactic use in pediatric TA-TMA. Development of the MASP-2 platform continues with the finalization of Phase 2 indications for the long-acting antibody OMS1030 and candidate selection for the oral small molecule program. Revenue guidance remains withheld as management seeks more experience with prescribing trends, patient demand, and the impact of upcoming reimbursement milestones. A permanent J-code became effective July 1, and a New Technology Add-on Payment (NTAP) providing up to $287,000 in additional reimbursement is scheduled for October 1. The company recorded a $12.1 million non-cash mark-to-market gain on embedded derivatives, a volatile figure tied directly to fluctuations in the common stock price. A $1.9 million loss was recognized in connection with the June agreement to repurchase convertible notes, reflecting the difference between fair value and carrying amount. Management noted that while pediatric adoption was rapid, institutional inertia at large academic centers remains a challenge for shifting diagnostic standards. One stock. Nvidia-level potential. 30M+ investors trust Moby to find it first. Get the pick. Tap here. Management does not view C5 inhibitors as direct competition because recent trials for ravulizumab missed their endpoints in both adult and pediatric settings. Continued off-label use of eculizumab is attributed to physician habit rather than clinical superiority, as Yartemlia targets the lectin pathway without compromising the adaptive immune response. Management clarified that sales figures are 'pure' and do not include channel stocking, as the drug is delivered within 24 hours of order. Distributor inventory has remained consistent at approximately 1.5 weeks of supply since the first quarter launch. Management noted they lack direct visibility into per-patient vial counts due to HIPAA, but ordering patterns are consistent across both demographics. Initial utilization may be higher per patient as centers currently treat the most severe cases, but vial requirements are expected to decrease as earlier diagnosis becomes standard.
Investor releaseQuarter not tagged2026-08-13Omeros Swings to Q2 Adjusted Earnings; Shares up
MT Newswires
Omeros Swings to Q2 Adjusted Earnings; Shares up
Omeros (OMER) reported Wednesday Q2 adjusted net earnings of $0.02 per diluted share, swinging from
Investor releaseQuarter not tagged2026-08-12Omeros: Q2 Earnings Snapshot
Associated Press
Omeros: Q2 Earnings Snapshot
SEATTLE (AP) — SEATTLE (AP) — Omeros Corporation (OMER) on Wednesday reported profit of $13.2 million in its second quarter. The Seattle-based company said it had profit of 15 cents per share. Earnings, adjusted for non-recurring gains and to account for discontinued operations, were 2 cents per share. The drug developer posted revenue of $28.5 million in the period. _____ This story was generated by Automated Insights (http://automatedinsights.com/ap) using data from Zacks Investment Research. Access a Zacks stock report on OMER at https://www.zacks.com/ap/OMER
Investor releaseQuarter not tagged2026-08-12Omeros (OMER) Q2 Earnings and Revenues Beat Estimates
Zacks
Omeros (OMER) Q2 Earnings and Revenues Beat Estimates
Omeros (OMER) came out with quarterly earnings of $0.02 per share, beating the Zacks Consensus Estimate of a loss of $0.27 per share. This compares to a loss of $0.53 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +107.41%. A quarter ago, it was expected that this drug developer would post a loss of $0.4 per share when it actually produced a loss of $0.24, delivering a surprise of +40%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Omeros, which belongs to the Zacks Medical - Products industry, posted revenues of $28.53 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 130.07%. This compares to zero revenues a year ago. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Omeros shares have lost about 20.8% since the beginning of the year versus the S&P 500's gain of 12.9%. While Omeros has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Omeros was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in th…Read full documentShow less
Omeros (OMER) came out with quarterly earnings of $0.02 per share, beating the Zacks Consensus Estimate of a loss of $0.27 per share. This compares to a loss of $0.53 per share a year ago. These figures are adjusted for non-recurring items. This quarterly report represents an earnings surprise of +107.41%. A quarter ago, it was expected that this drug developer would post a loss of $0.4 per share when it actually produced a loss of $0.24, delivering a surprise of +40%. Over the last four quarters, the company has surpassed consensus EPS estimates four times. Omeros, which belongs to the Zacks Medical - Products industry, posted revenues of $28.53 million for the quarter ended June 2026, surpassing the Zacks Consensus Estimate by 130.07%. This compares to zero revenues a year ago. The sustainability of the stock's immediate price movement based on the recently-released numbers and future earnings expectations will mostly depend on management's commentary on the earnings call. Omeros shares have lost about 20.8% since the beginning of the year versus the S&P 500's gain of 12.9%. While Omeros has underperformed the market so far this year, the question that comes to investors' minds is: what's next for the stock? There are no easy answers to this key question, but one reliable measure that can help investors address this is the company's earnings outlook. Not only does this include current consensus earnings expectations for the coming quarter(s), but also how these expectations have changed lately. Empirical research shows a strong correlation between near-term stock movements and trends in earnings estimate revisions. Investors can track such revisions by themselves or rely on a tried-and-tested rating tool like the Zacks Rank, which has an impressive track record of harnessing the power of earnings estimate revisions. Ahead of this earnings release, the estimate revisions trend for Omeros was unfavorable. While the magnitude and direction of estimate revisions could change following the company's just-released earnings report, the current status translates into a Zacks Rank #4 (Sell) for the stock. So, the shares are expected to underperform the market in the near future. You can see the complete list of today's Zacks #1 Rank (Strong Buy) stocks here. It will be interesting to see how estimates for the coming quarters and the current fiscal year change in the days ahead. The current consensus EPS estimate is -$0.22 on $19.3 million in revenues for the coming quarter and -$0.13 on $68.8 million in revenues for the current fiscal year. Investors should be mindful of the fact that the outlook for the industry can have a material impact on the performance of the stock as well. In terms of the Zacks Industry Rank, Medical - Products is currently in the top 44% of the 250 plus Zacks industries. Our research shows that the top 50% of the Zacks-ranked industries outperform the bottom 50% by a factor of more than 2 to 1. One other stock from the same industry, FitLife Brands Inc. (FTLF), is yet to report results for the quarter ended June 2026. The results are expected to be released on August 13. This company is expected to post quarterly earnings of $0.18 per share in its upcoming report, which represents no change from the year-ago quarter. The consensus EPS estimate for the quarter has remained unchanged over the last 30 days. FitLife Brands Inc.'s revenues are expected to be $26.5 million, up 64.3% from the year-ago quarter. Want the latest recommendations from Zacks Investment Research? Today, you can download 7 Best Stocks for the Next 30 Days. Click to get this free report Omeros Corporation (OMER) : Free Stock Analysis Report FitLife Brands Inc. (FTLF) : Free Stock Analysis Report This article originally published on Zacks Investment Research (zacks.com). Zacks Investment Research
Investor releaseQuarter not tagged2026-08-12Omeros Corporation Reports Second Quarter 2026 Financial Results
Business Wire
Omeros Corporation Reports Second Quarter 2026 Financial Results
– Conference Call Today at 4:30 p.m. ET SEATTLE, August 12, 2026--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the second quarter ended June 30, 2026, which include: Second Quarter and Recent Highlights YARTEMLEA®, the first and only approved treatment for stem cell transplant-associated thrombotic microangiopathy (TA-TMA), an often-lethal complication of stem cell transplantation, generated gross revenues of $32.2 million in the second quarter of 2026, an increase of 190% from $11.1 million in the first quarter. Net revenue was $28.5 million, reflecting gross-to-net adjustments of approximately 11.5%, compared with $9.9 million and 11.0%, respectively, in the first quarter. Net income for the second quarter of 2026 was $13.2 million, or $0.18 per share, compared to net income of $56.1 million, or $0.78 per share for the first quarter of 2026. Results for the second and first quarters of 2026 included non-cash gains of $11.5 million and $73.1 million, respectively, primarily related to the mark-to-market adjustment of the embedded derivative associated with our unsecured convertible notes due 2029 (the "2029 Notes"). Excluding these non-cash gains, non-GAAP adjusted net income for the second quarter of 2026 was $1.8 million, or $0.02 per share, compared with a non-GAAP adjusted net loss of $17.1 million, or $0.24 per share, for the first quarter. At June 30, 2026, we had $132.0 million of cash and short-term investments. For the three months ended June 30, 2026, company-wide net cash provided by operations was $4.1 million. In July 2026, we completed the repurchase of $30.5 million aggregate principal amount of our 2029 Notes for a total purchase price of $60.2 million, reducing the outstanding principal amount to approximately $40.3 million. The transactions also reduced the aggregate number of shares issuable upon conversion of the 2029 Notes from approximately 11.4 million to 6.5 million and eliminated $8.6 million in future interest payments. During the three and six months ended June 30, 2026, we repurchased and retired approximately 0.5 million and 0.8 million shares of common stock, respectively, at an average cost of $11.70 per share, respectively, for aggregate purchase prices of $5.7 million and $9.9 million, respectively. In June, the Committee for Medicinal…Read full documentShow less
– Conference Call Today at 4:30 p.m. ET SEATTLE, August 12, 2026--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the second quarter ended June 30, 2026, which include: Second Quarter and Recent Highlights YARTEMLEA®, the first and only approved treatment for stem cell transplant-associated thrombotic microangiopathy (TA-TMA), an often-lethal complication of stem cell transplantation, generated gross revenues of $32.2 million in the second quarter of 2026, an increase of 190% from $11.1 million in the first quarter. Net revenue was $28.5 million, reflecting gross-to-net adjustments of approximately 11.5%, compared with $9.9 million and 11.0%, respectively, in the first quarter. Net income for the second quarter of 2026 was $13.2 million, or $0.18 per share, compared to net income of $56.1 million, or $0.78 per share for the first quarter of 2026. Results for the second and first quarters of 2026 included non-cash gains of $11.5 million and $73.1 million, respectively, primarily related to the mark-to-market adjustment of the embedded derivative associated with our unsecured convertible notes due 2029 (the "2029 Notes"). Excluding these non-cash gains, non-GAAP adjusted net income for the second quarter of 2026 was $1.8 million, or $0.02 per share, compared with a non-GAAP adjusted net loss of $17.1 million, or $0.24 per share, for the first quarter. At June 30, 2026, we had $132.0 million of cash and short-term investments. For the three months ended June 30, 2026, company-wide net cash provided by operations was $4.1 million. In July 2026, we completed the repurchase of $30.5 million aggregate principal amount of our 2029 Notes for a total purchase price of $60.2 million, reducing the outstanding principal amount to approximately $40.3 million. The transactions also reduced the aggregate number of shares issuable upon conversion of the 2029 Notes from approximately 11.4 million to 6.5 million and eliminated $8.6 million in future interest payments. During the three and six months ended June 30, 2026, we repurchased and retired approximately 0.5 million and 0.8 million shares of common stock, respectively, at an average cost of $11.70 per share, respectively, for aggregate purchase prices of $5.7 million and $9.9 million, respectively. In June, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) adopted a negative opinion on our marketing authorization application (MAA) for narsoplimab in TA-TMA. We believe the clinical evidence supports approval and have requested re-examination. As part of the re-examination procedure, an Ad Hoc Expert Group (AHEG), expected to comprise external scientific and clinical experts in hematology and stem cell transplantation, will review the evidence and address questions central to CHMP’s assessment. We continue to make YARTEMLEA available to transplant physicians and their patients in Europe through our expanded access program, prioritizing children with TA-TMA. "We are very pleased with the strong momentum and growing market acceptance in the first full quarter of YARTEMLEA’s commercial launch," said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. "Equally gratifying are the consistent reports from transplant physicians nationwide describing responses to YARTEMLEA in their adult and pediatric patients, including those who had not responded to prior off-label C5 inhibitor administration. YARTEMLEA is saving lives and, with FDA approval, is now broadly accessible in the U.S. Substantial second-quarter YARTEMLEA revenues have enabled us to continue strengthening our capital structure. We repurchased an additional 489,000 shares of common stock in the open market and reduced the outstanding principal amount of our 2029 convertible notes by 43%, eliminating nearly $9 million in future cash interest payments and approximately 5 million additional shares of potential dilution. At the same time, our work with Novo Nordisk on the MASP-3 inhibitor zaltenibart remained on track toward Phase 3 trial initiation, while our complement, addiction, oncology, and infectious disease programs continued advancing. Collectively, these programs position Omeros for a broad range of value-driving milestones over the next 18 months." Recent Developments YARTEMLEA and our broader MASP-2 inhibitor platform OMS527 for the treatment of addiction — cocaine use disorder program funded by the National Institute on Drug Abuse ("NIDA") Oncology platform — OncotoX-AML/OMS805 Targeted Complement Activating Therapy ("T-CAT") platform Financial Results YARTEMLEA gross revenues were $32.2 million during the second quarter of 2026, an increase of $21.1 million, or 190%, from gross revenues of $11.1 million in the first quarter of 2026. Net revenue was $28.5 million, reflecting gross-to-net adjustments of approximately 11.5%, compared with $9.9 million, and gross-to-net adjustments of approximately 11.0% in the first quarter of 2026. Net income for the second quarter of 2026 was $13.2 million, or $0.18 per share, compared to net income of $56.1 million, or $0.78 per share, for the first quarter of 2026. Results for the second and first quarters of 2026 included non-cash gains of $11.5 million and $73.1 million, respectively, primarily related to the mark-to-market adjustment of the embedded derivative associated with our 2029 Notes. Excluding these non-cash gains, non-GAAP adjusted net income for the second quarter of 2026 was $1.8 million, or $0.02 per share, compared with a non-GAAP adjusted net loss of $17.1 million, or $0.24 per share, for the first quarter of 2026. At June 30, 2026, we had $132.0 million of cash and short-term investments. For the three months ended June 30, 2026, company-wide net cash provided by operations was $4.1 million. On June 17, 2026, we entered into privately negotiated agreements to repurchase $16.0 million aggregate principal amount of 2029 Notes from certain holders. On July 2, 2026, we entered into additional privately negotiated agreements with the same holders to repurchase $14.5 million aggregate principal amount of 2029 Notes. Both transactions were completed in July 2026 for a total purchase price of $60.2 million, plus accrued and unpaid interest of $0.2 million. Approximately $40.3 million aggregate principal amount of 2029 Notes remains outstanding. The aggregate number of shares issuable on conversion of the 2029 Notes was reduced from approximately 11.4 million to 6.5 million as a result of the transactions. We achieved this reduction at a weighted average cost of $12.21 per share and concurrently eliminated $8.6 million in future interest payments. Research and development and selling, general and administrative expenses totaled approximately $27.7 million in the second quarter, compared with $26.7 million in the first quarter. We reported operating income of $0.1 million for the second quarter compared with an operating loss of $17.4 million for the first quarter. Interest and other income was $4.6 million for the second quarter of 2026 as compared to $1.5 million during the first quarter of 2026. The $3.1 million increase was primarily the result of a reimbursement from Novo Nordisk for the transfer of zaltenibart inventory. During the three months ended June 30, 2026, we repurchased and retired approximately 0.5 million shares of common stock pursuant to our share repurchase program, at an average cost of $11.70 per share, for an aggregate purchase price of $5.7 million. During the six months ended June 30, 2026, we repurchased and retired approximately 0.8 million shares of common stock pursuant to our share repurchase program, at an average cost of $11.70 per share, for an aggregate purchase price of $9.9 million. 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, please register at the following URL https://events.q4inc.com/attendee/777037727 or go to Omeros’ website at https://investor.omeros.com/upcoming-events. A replay of the call will be made accessible online for 90 days at https://investor.omeros.com/archived-events. About Omeros Corporation Omeros is an innovative biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for both large-market and orphan indications, with a focus on the treatment of complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead complement inhibitor YARTEMLEA® (narsoplimab-wuug), which targets the lectin pathway’s effector enzyme MASP-2, is FDA-approved and commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients two years of age and older. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials. Under an asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), an inhibitor of MASP-3, the alternative pathway’s key activator, which is in clinical development for PNH and other alternative pathway indications, along with associated intellectual property and related assets. Omeros’ pipeline also includes OMS527, a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder, which is fully funded by the National Institute on Drug Abuse, and a growing portfolio of novel recombinant antibodies targeting multidrug-resistant organisms and novel molecular and cellular therapeutic programs for oncology. 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 therapeutic benefits of drug candidates within our development pipeline, statements of intention or expectations regarding our marketing authorization application for narsoplimab in Europe, plans and expectations regarding the commercial launch of YARTEMLEA® in the U.S., and in the EU following any EMA approval, our expectations regarding the effectiveness of the J-code and its utility, our ability to consummate licensing, partnering or other transactions and the benefits, if any, we would receive from any such transactions, expectations regarding the sufficiency and availability of our capital resources to fund current and planned operations, including the commercialization of YARTEMLEA 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 regulatory conclusions or interpretations related to the clinical data, external registry data, statistical analyses or other information and data included in our marketing authorization application or our inability to respond satisfactorily to information requests during regulatory review, unanticipated or unexpected outcomes or requirements of regulatory processes in relevant jurisdictions, our financial condition and results of operations, including our ability to raise additional capital for our operations or complete other transactions on favorable terms or at all, 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, 2026 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. Non-GAAP Financial Measures This press release includes financial measures that are not calculated in accordance with U.S. generally accepted accounting principles (GAAP). A non-GAAP financial measure is generally defined as one that purports to measure historical or future financial position, results of operations or cash flows but excludes or includes amounts that would not be included in most GAAP measures. We define non-GAAP adjusted net income (loss) as GAAP net income (loss) adjusted to exclude the non-cash remeasurement of the fair value of financial instruments. We believe non-GAAP adjusted net income (loss) to be a more accurate measure in evaluating the Company’s performance because it excludes the fluctuation in the fair value of Omeros’ embedded derivatives. This is not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Omeros’ financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting. View source version on businesswire.com: https://www.businesswire.com/news/home/20260812018593/en/ Contacts Jennifer Cook WilliamsCook Williams Communications, Inc.Investor and Media [email protected]
TranscriptFY2026 Q22026-08-12FY2026 Q2 earnings call transcript
Earnings source - 65 paragraphs
FY2026 Q2 earnings call transcript
Please be advised that this call is being recorded at the company's request, and a replay will be available on the company's website. I will now turn the call over to Jennifer Williams, Investor Relations for Omeros. Please go ahead.
Thank you, and good afternoon, everyone. Before we begin, please note that today's discussion will include forward-looking statements. These statements reflect management's current expectations and beliefs as of today and are subject to risks and uncertainties that could cause actual results to differ materially. For a detailed discussion of these risks and uncertainties, please refer to the special note regarding forward-looking statements and the risk factors in our quarterly report on Form 10-Q, filed today with the SEC, as well as our most recent annual report on Form 10-K. Today's call also will include certain non-GAAP financial measures.
A reconciliation of these measures to the corresponding GAAP measures is included in Omeros' earnings release issued earlier today, available on the Investor Relations page of our website and furnished with the Form 8-K we filed today with the SEC. With that, I will turn the call over to Dr. Gregory Demopulos, Chairman and CEO of Omeros.
Thank you, Jennifer, and good afternoon, everyone. Joining me today are David Borges, our Chief Accounting Officer, Dr. Catherine Melfi, our Chief Regulatory Officer, Dr. Steve Whitaker, Vice President of Clinical, and Bill Woodman, our Chief Commercial Officer. Promoted from within the company, Bill was recently appointed as our Chief Commercial Officer. Let me tell you a bit more about him. Bill joined Omeros six years ago as our Vice President of Sales and Market Development, bringing more than 25 years of industry experience, including sales and marketing leadership roles at Amgen, Spectrum Pharmaceuticals, and Jazz Pharmaceuticals, where he led the global launch of defibrotide. At Omeros, Bill largely built our commercial team and was instrumental in designing and executing the YARTEMLEA launch. I have long believed that Bill's background, capabilities, and achievements are ideally suited to Omeros' current and future objectives.
Under his leadership, our commercial team is driving YARTEMLEA toward becoming the standard of care for TA-TMA and preparing for its expansion into a broad range of MASP-2-driven indications. Beyond complement, Bill's track record of driving growth across oncology, rare disease, and specialty biopharma products will serve Omeros well. Before I turn to the financial details, let me highlight three points. First, YARTEMLEA generated $32.2 million in gross sales in its first full quarter on the market. Second, operations generated $4.1 million of positive cash flow during the quarter. And third, we meaningfully strengthened our capital structure through our share and note repurchases. I'll now begin with an overview of our second quarter operations and financial results, followed by program updates. David will then review the financials in more detail, after which we'll open the call for questions.
As you know, the FDA approved YARTEMLEA, our lead MASP-2 inhibitor, in December 2025 for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA. YARTEMLEA is the first and only approved treatment for this often fatal complication of stem cell transplantation, and YARTEMLEA is also the first and only approved inhibitor of the lectin pathway of complement. We launched YARTEMLEA in mid-January, with initial distributor shipments beginning mid-month and first sales following shortly thereafter. The second quarter was our first full quarter of YARTEMLEA sales, and we're pleased to share the results today. As I mentioned, in the second quarter, YARTEMLEA generated $32.2 million in gross sales and $28.5 million in net sales, reflecting strong physician adoption and market penetration, and a gross to net adjustment of 11.5%. Compared with the first quarter, gross sales increased 190% and net sales increased 188%.
We'll discuss the launch in more detail in just a bit. Net income for the second quarter was $13.2 million, or $0.18 per share. As we have previously discussed, our reported results include non-cash mark-to-market adjustments related to the derivative embedded in our 2029 convertible notes. Excluding non-cash remeasurements of embedded derivatives and other financial instruments, second quarter non-GAAP adjusted net income was $1.8 million or $0.02 net income per share. David will walk through the quarter-over-quarter comparisons and accounting detail shortly. We ended the quarter with $132 million in cash and investments. Importantly, company-wide operations provided net positive cash flow in the second quarter of $4.1 million. Our share repurchases and subsequent note repurchases further strengthened our capital structure. During the six months ended June 30, we repurchased and retired approximately 843,000 shares of Omeros common stock.
Nearly 60% of those shares in the second quarter at a volume-weighted average price of $11.70 per share. Then in July, through two privately negotiated transactions, we repurchased $30.5 million aggregate principal amount of our 9.5% convertible notes due in 2029, reducing the outstanding principal by 43% to $40.3 million. The repurchases also reduced the number of shares issuable upon conversion from approximately 11.4 million to 6.5 million shares. We achieved this reduction at a weighted average cost of $12.21 per underlying conversion share and concurrently eliminated $8.6 million in future interest payments. Together, our open market share repurchases and our negotiated note repurchases have reduced our potential fully diluted share count by 5.8 million shares year to date. Turning back to YARTEMLEA, our launch remains focused on four priorities. One, educating transplant teams to recognize and treat TA-TMA earlier.
Two, securing institutional access through Pharmacy and Therapeutics or P&T committee approvals and streamlined ordering. Three, ensuring timely reimbursement. And four, demonstrating YARTEMLEA's economic value through health economics and outcomes research or HEOR. Together, these priorities are intended to change how transplant centers approach TA-TMA. Historically, particularly at adult transplant centers, TA-TMA often has been treated as a diagnosis of exclusion and considered only after other potential causes are ruled out. We are working to shift that paradigm toward proactive screening, enabling clinicians to identify and treat more patients earlier and ultimately improve transplant outcomes. Execution remains strong. Our field sales organization is actively engaging all 175 U.S. transplant centers. As of June 30, 73 unique accounts had ordered YARTEMLEA, a 143% increase since March 31. As discussed on our first quarter call, pediatric patients initially represented an outsized share of utilization.
With rapid adoption at adult transplant centers, however, the mix has shifted significantly. In the second quarter, adult utilization grew at more than twice the rate of pediatric utilization, and adult patients represented approximately 75% of YARTEMLEA sales. This mix is closely approaching the historical 85%/15% split between adult and pediatric transplant procedures in the U.S. Formulary adoption also continues to progress rapidly. By quarter end, we understand that YARTEMLEA had received P&T committee approval at approximately 55%-60% across the top 10, 20, 40, and 80 U.S. transplant center cohorts that we track. Ordering frequency also increased meaningfully, indicating deeper utilization within centers. We also achieved key reimbursement milestones during the quarter. The Centers for Medicare & Medicaid Services, or CMS, assigned YARTEMLEA a permanent product-specific Healthcare Common Procedure Coding System or HCPCS J-code effective July 1.
The J-code establishes a clear and consistent outpatient reimbursement pathway, reduces administrative burden, and supports more predictable payment for providers. CMS also recommended a new technology add-on payment or NTAP for YARTEMLEA under the fiscal year 2027 proposed rule for the Inpatient Prospective Payment System, or IPPS, and has now granted the NTAP in the final IPPS rule. The NTAP provides up to $287,000 in additional Medicare reimbursement for inpatient treatment with YARTEMLEA. This is particularly important because Medicare beneficiaries represent approximately 30% of U.S. allogeneic transplant recipients. The NTAP for YARTEMLEA is expected to become effective October 1. Commercial payer experience also remains positive. Prior authorization requests are being approved consistently, and centers receiving appropriate payment reflect growing acceptance of YARTEMLEA among commercial insurers. We are preparing our HEOR analyses for presentation at upcoming scientific meetings and for peer-reviewed publication.
We expect these analyses to further demonstrate YARTEMLEA's clinical and economic value and support continued adoption. Overall, early commercial indicators, including strong transplant center engagement, continued formulary and ordering momentum, and payer alignment with the approved label, reinforce our expectation that YARTEMLEA can become the standard of care for TA-TMA. Looking ahead, we continue to pursue expansion opportunities for YARTEMLEA and our broader MASP-2 platform. In June, following an oral explanation before the European Medicines Agency's Committee for Medicinal Products for Human Use, or CHMP, the committee adopted a negative opinion on our marketing authorization application for YARTEMLEA in TA-TMA. We believe the clinical evidence supports approval and have requested re-examination.
The application is supported by our pivotal narsoplimab trial data in TA-TMA survival analyses comparing narsoplimab-treated patients with an external registry of patients who did not receive narsoplimab and data from more than 220 adult and pediatric patients treated through our expanded access program. This same body of evidence supported YARTEMLEA's FDA approval. As part of the re-examination, an Ad Hoc Expert Group, or AHEG, comprising independent external scientific and clinical experts in hematology, stem cell transplantation, and TA-TMA, will review the evidence and address questions central to CHMP's assessment. The AHEG will hear from Omeros and from transplant experts with direct experience using narsoplimab, and new rapporteurs will review the application. We remain focused on obtaining approval in Europe. Meanwhile, we continue to provide YARTEMLEA to European patients with TA-TMA through our expanded access program, prioritizing children. We also continue to assess opportunities to expand the YARTEMLEA label.
We are prioritizing indications with a strong biologic rationale for MASP-2 inhibition, particularly those involving endothelial injury, lectin pathway activation, and thromboinflammation. These encompass an extensive list of indications, including chemotherapy-induced TA-TMA, acute respiratory distress syndrome or ARDS, and other transplant-related endothelial injury syndromes. We plan to evaluate new indications through preclinical research, investigator-initiated studies, and clinical trials, each as appropriate. By year-end, we expect enrollment to begin in two investigator-sponsored and Omeros-supported studies, one evaluating YARTEMLEA in hyperinflammatory ARDS, and the other assessing prophylactic YARTEMLEA in pediatric patients with predictably severe TA-TMA. Our MASP-2 platform extends beyond YARTEMLEA. We are advancing our phase II-ready long-acting MASP-2 antibody OMS1029 and an oral small molecule MASP-2 inhibitor program. Both are designed for chronic indications requiring long-term administration, including membranous nephropathy and neurodegenerative diseases such as Parkinson's disease and Alzheimer's disease.
In phase I clinical trials, OMS1029 demonstrated the clear ability to inhibit MASP-2 over an extended duration with once quarterly subcutaneous or intravenous dosing. Our small molecule MASP-2 inhibitor is targeting once-daily oral dosing. We are finalizing selection of the initial phase II indication for OMS1029. Clinical drug product and matching placebo have been manufactured and are available. For our MASP-2 small molecule program, we have one ongoing study to complete, after which we expect to select an orally delivered development candidate for that program. Our collaboration with Novo Nordisk also continues to progress smoothly. The Novo transaction provides up to $2.1 billion in upfront and milestone payments, plus royalties ranging from high single digits to the high teens. At closing in the fourth quarter of 2025, we received $240 million in upfront cash, which funded the YARTEMLEA launch and other operations.
We also are eligible to receive up to an additional $100 million in near-term milestone payments. Our interactions with Novo remain collaborative and productive, and we continue to provide transition services at Novo's cost. Turning now to development programs beyond our complement inhibitor franchise, our PDE7 inhibitor program evaluating OMS527 for cocaine use disorder remains fully funded by a grant from the National Institute on Drug Abuse, or NIDA. Earlier this year, we met with FDA regarding the agency's request for additional non-clinical information before initiating the inpatient study. That non-clinical work has initiated, and we expect to start enrollment in the inpatient clinical trial by year-end. Based on its mechanism of action and our extensive preclinical data, we believe that OMS527 could be effective across a broad range of addiction and compulsive disorders.
Our targeted complement activating therapy, or T-CAT platform, is a novel class of recombinant antibodies designed to target and directly kill pathogens, including bacteria, fungi, viruses, and parasites. Our initial focus is on infections caused by multi-drug resistant organisms among medicine's most critical unmet needs. Unlike antimicrobial agents on the market, T-CAT is designed to kill pathogens regardless of resistance profile and without promoting or enhancing resistance. The foundational manuscript describing our T-CAT technology was published in Science Translational Medicine in June of this year. The manuscript details the technology and demonstrates that T-CAT monoclonal antibodies safely and effectively treated infections in translationally relevant murine models of sepsis and pneumonia caused by multiple different drug-resistant bacterial species prioritized by the World Health Organization as posing the greatest threat to human health. The data underscore T-CAT's potential as a next-generation platform with broad applicability across microbial species, including multi-drug resistant pathogens.
We look forward to advancing T-CAT toward the clinic. Finally, OncotoX-AML, or OMS805, is the lead program in our oncology platform. It's an engineered biologic designed to treat acute myeloid leukemia, or AML, the most common and one of the deadliest acute leukemias in adults. Across tumor-bearing animal models and in vitro human AML cell line studies, OncotoX-AML has consistently demonstrated efficacy superior to current standards of care, even at very low doses. Importantly, this efficacy was independent of AML-related mutations, including TP53 and FLT3, which historically have been very difficult to treat. In a non-human primate study, a single course of OncotoX-AML produced the desired pharmacologic response, a marked selective reversible and dose-related reduction in myeloid progenitor cells by up to 99%. Treatment was well-tolerated, with no safety signal of concern.
We have entered into agreement with a leading contract biologics manufacturer for process development and clinical supply of OMS805 drug substance. IND-enabling studies are underway. Given the novelty of the OncotoX program, its potential applicability across hematologic malignancies, and the breadth of our unpublished data and pending patent claims, we plan to limit further public disclosure until OMS805 enters human studies and begins generating clinical data. Working with our advisory board of leading AML experts, we are preparing for a first-in-human trial targeted to begin in late 2027. That concludes our corporate and program update. I'll now turn the call over to David for a more detailed review of our financial results. David?
Thanks, Gregory. Our second quarter results reflect continued focus on commercial execution of the YARTEMLEA launch and actions to strengthen our capital structure. Net income for the second quarter of 2026 was $13.2 million, or $0.18 per share, compared with net income of $56.1 million, or $0.78 per share in the first quarter of 2026. Second quarter results included a $12.1 million non-cash mark-to-market gain on the embedded derivative associated with our 2029 convertible notes and a $700,000 remeasurement loss on our payment obligation for the 2029 note repurchases. By comparison, first quarter results included a $73.1 million non-cash mark-to-market gain on the embedded derivative associated with the 2029 convertible notes. To provide additional visibility into our operating performance, we also present non-GAAP adjusted results that exclude non-cash remeasurements of embedded derivatives and other financial instruments.
Excluding these non-cash remeasurements, non-GAAP adjusted net income for the second quarter was $1.8 million, or $0.02 net income per share, compared with a non-GAAP adjusted net loss of $17.1 million, or $0.24 net loss per share for the first quarter. As of June 30, 2026, we had $132 million in cash and investments, and company-wide net cash provided by operations in the second quarter was $4.1 million. During the second quarter, we repurchased and retired approximately 489,000 shares of our common stock at an average price of $11.70 per share, for a total of $5.7 million. Through June 30, 2026, we had repurchased and retired approximately 843,000 shares at the same average price, for a total of $9.9 million. In June and July of 2026, we entered into agreements for two privately negotiated cash repurchases, totaling $30.5 million aggregate principal amount of our 2029 convertible notes.
Both transactions closed in July, reducing our outstanding debt, which consists solely of the 2029 notes, by approximately 43%, from $70.8 million to $40.3 million. The aggregate purchase price was $60.2 million, plus $200,000 of accrued and unpaid interest. These transactions reduced leverage, future cash interest expense, and potential dilution by opportunistically repurchasing and retiring a portion of the 2029 convertible notes. They also reduced the number of shares issuable on conversion from approximately 11.4 million to 6.5 million. As Gregory noted, YARTEMLEA maintains strong commercial momentum in the second quarter. Gross product revenues were $32.2 million, all from YARTEMLEA sales, compared with $11.1 million in the first quarter, and net revenues were $28.5 million, compared with $9.9 million in the first quarter. Gross-to-net adjustments were approximately 11.5%, compared with approximately 11% in the first quarter, and remained within our expectations. These adjustments consisted primarily of chargebacks and distribution fees.
Costs and expenses from continuing operations before interest and other income were $28.5 million, an increase of $1.1 million from the first quarter. Under the transition services agreement entered into in connection with the zaltenibart transaction, we continue to be reimbursed for costs incurred in providing transition services, including third-party expenses and internal personnel costs. We also recognized $3.3 million of reimbursement from Novo Nordisk for zaltenibart inventory transfer during the quarter, which we recorded in other income. Interest expense was $7.6 million. The primary components were the DRI royalty obligation and interest on the 2029 convertible notes. Excluding the OMIDRIA royalty obligations to DRI, which is fully offset by amounts received from Rayner and therefore has no economic impact on Omeros, and non-cash amortization of debt issuance costs and discounts, contractual cash interest expense was $1.7 million, down $100,000 from the first quarter.
Interest and other income totaled $4.6 million in the second quarter, compared with $1.5 million in the first quarter. The increase was primarily attributable to the Novo Nordisk inventory reimbursement. As previously noted, we recorded a $12.1 million non-cash mark-to-market gain on the embedded derivative related to our 2029 convertible notes. The change was driven primarily by the decline in our stock price from $10.56 per share at March 31st to $9.51 per share at June 30th. Because the derivative's value is closely tied to our stock price, increases in our share price generally produce non-cash losses, while decreases generally produce non-cash gains. This adjustment does not affect our operating performance or liquidity and is excluded from our non-GAAP adjusted results. Following the July note repurchases, future mark-to-market adjustments will reflect the reduced principal balance.
In connection with the June agreement to repurchase the first tranche of our 2029 convertible notes, comprising a $16 million principal amount, we recorded a $1.9 million loss. The loss reflects the difference between the fair value of the payment obligation, the carrying amount of the repurchased notes, net of unamortized discount and issuance costs, and the derecognition of the associated embedded derivative liability. Because the agreements for the second tranche, comprising a $14.5 million principal amount, were entered into in July 2026, the related accounting will be reflected in our third-quarter results. Income from discontinued operations in the second quarter was $6.6 million, up $1.8 million from the first quarter, primarily due to a lower remeasurement adjustment. Because U.S. OMIDRIA royalties pass directly to DRI, fluctuations in these payments do not affect our cash position. Now, let me turn to our expectations for the third quarter of 2026.
We expect total operating expenses from continuing operations to be slightly higher than in the second quarter. Research and development expenses are expected to increase primarily due to increased spending on our OMS805 OncotoX program. Sales and marketing expenses are also expected to increase, reflecting continued investment in YARTEMLEA commercial infrastructure, marketing, and launch activities. Although we're encouraged by YARTEMLEA's continued commercial momentum, we're not providing revenue guidance at this time. We believe it is prudent to gain additional experience with prescribing trends, patient demand, and market dynamics. We remain focused on expanding physician awareness and disease education and ensuring continued timely reimbursement. Interest and other income are expected to be lower in the third quarter, primarily because the Novo Nordisk inventory reimbursement recognized in the second quarter will not recur. Interest expense is expected to be approximately $6.5 million, reflecting the reduction in the outstanding debt following the repurchases.
This estimate excludes potential non-cash adjustments related to the OMIDRIA royalty obligation. Income from discontinued operations is expected to be between $5 million and $6 million, again, excluding any remeasurement adjustments related to the OMIDRIA contract royalty asset. As a reminder, our reported results will continue to reflect mark-to-market adjustments on the embedded derivative relating to our remaining 2029 convertible notes. These adjustments are non-cash, they can be volatile, and are driven largely by stock price and other market inputs. We therefore present non-GAAP adjusted net income and loss to provide additional visibility into underlying operating performance. With that, I'll turn the call back over to Gregory. Gregory?
Thanks, David. Operator, please open the call to questions.
We will now begin the question and answer session. If you would like to ask a question, please raise your hand now. The raise hand button can be found in the center of the toolbar at the bottom of your screen on Zoom desktop and on the left side of the toolbar on Zoom mobile. If you have dialed into today's call, please press star nine to raise your hand and star six to unmute. Please stand by while we compile the Q&A roster. Your first question comes from the line of Brandon Folkes with H.C. Wainwright. Your line is open. Please go ahead.
Hi. Thanks for taking my questions, and congrats on a very good quarter. Maybe just two from me. I guess firstly, with the AstraZeneca ULTOMIRIS data released, are you having any updated conversations around C5 use at all? Obviously, it's off-label, right? But I guess any color in terms of why a transplant center would still use the C5 at all for these TA-TMA patients. Secondly, obviously very big quarter here. Congrats on that. Meaningfully ahead of a lot of forecasts. I wanted to see if you could just try put this in perspective relative to your internal forecasts, especially the company-wide cash flow forecast you put out earlier. Along those lines, do you still expect month-to-month variability as you called out at your AGM? Thank you.
Thanks, Brandon. With respect to the first question regarding C5 inhibition, as you noted, ravulizumab previously missed the endpoint on its open label pediatric study, and then recently reported that it as well had missed the endpoint on its controlled adult trial. As far as we all understand and you understand, they did not meet their endpoints across any of the ravulizumab TA-TMA trials. Your question as to whether there remains off-label, primarily eculizumab use, because the dosing, frankly, for ravulizumab is not really conducive to the acute indication of TA-TMA. Eculizumab is more frequently dosed, shorter half-life. There is some continued eculizumab off-label use. We don't really know how much. We don't, frankly, focus on how much. I'll ask Bill to speak to that and his thoughts around the competition there, which I'll preempt a bit by saying we don't really see it as competition for YARTEMLEA.
I think with respect to why there might be continued use for a while of eculizumab, I think certainly it's hard to break old habits among physicians, and that is likely what we're seeing. But when you look at the adoption of narsoplimab, the breadth of the adoption, the depth of the adoption, I think that speaks volumes about how physicians see our drug. I also think certainly the safety profile. Let's put aside the efficacy, which we're very pleased with the efficacy that we're seeing with narsoplimab in the commercial setting. But let's look at the safety issues. Narsoplimab is not associated with the same issues as C5 inhibition. It's a biological fact. When you inhibit C5, you inhibit the lytic arm of the classical pathway that increases the risk of infection. Inhibition of MASP-2 with narsoplimab or YARTEMLEA is upstream.
We're inhibiting the lectin pathway at really near the top of the lectin pathway. By doing so, we maintain that adaptive immune response. With respect to why folks would, physicians would continue for a while to use eculizumab, I think the best answer to that is one of habit and just perhaps not fully understanding the benefits yet that YARTEMLEA brings. But I frankly expect that that will not be a long-lived challenge for us. Bill, let me ask you to comment on that.
Sure. Thanks, Gregory. I totally agree. Physicians are humans too, and humans generally do not welcome change with open arms. Eculizumab was their only option for 10 or 12 or 15 years. In peds, it was widely adopted. Adults, not so much. But in peds, even in peds, we're seeing adoption across centers, use in both first and second line. In adults, it's pretty much first line. We expect this to be a temporary hiccup to our goal of being really the best-in-class first-line therapy for TA-TMA in both adult and pediatric centers.
Thank you, Bill. Brandon, your next question was how our internal forecasts, I believe, compare to what we've seen. We won't comment today on our internal or external forecasts. We won't guide. The other part of that question, I think, though, was around our cash flow forecast. Certainly, we hold to our statement previously that by mid-2027, we expect to be cash flow positive company-wide. In fact, you saw the result we generated this quarter from operations, $4.1 million of net positive cash. I think we're quite comfortable holding to that prediction. David, any comments on that?
No, I would say that states it really well, and agree with what you just said, Gregory.
Thank you. Anything else, Brandon?
No, other than to say congrats on a really good quarter and a good launch, so far.
Thank you. Thank you very much.
Your next question comes from the line of Steve Brozak with WBB. Your line is open. Please go ahead.
Yes. Hey, good afternoon, Gregory, and obviously thank you for taking these questions, and congrats on these numbers. I am thrilled, and I am sure the patients being treated with your YARTEMLEA are also thrilled. Financial questions. Can you just iterate, are any of these numbers from any kind of channel stocking, or do they represent pure numbers for drug going out? I have a follow-up after that, please.
Sure. Thanks, Steve. In answer to that first question, no. Categorically, no. This drug is available to patients from the wholesaler or distributor to the medical centers within 24 hours. There really is no incentive or rationale to stock or stuff the channel. Frankly, we have seen inventories at about 1.5 weeks of supply, and that has been consistent since Q1, really. Since the very first quarter, it has been quite consistent at about 1.5 weeks of supply held by the distributors. The answer to your question is really no. These are, as you put it, I will use your term, these are pure numbers.
Okay. Thank you. Last question, and I will jump back in the queue. NTAPs, okay? I have been familiar with different NTAP programs, but your numbers are obviously much, much higher. In terms of reimbursement, can you tell us the NTAP process and how you are set up for that? Because that is something that not that many people are familiar with. I will hop back in the queue. Thank you.
Sure. NTAP is a CMS program that frankly subsidizes the cost of new drugs entering the market while that period of time occurs over which the DRGs are adjusted to account for those new drugs. As you know, CMS has set an amount up to $287,000 for a course of treatment for YARTEMLEA. We are quite pleased with that. It is at that roughly 65% cap that CMS will allow. CMS, as you saw in their proposed IPPS rule, recommended the NTAP for YARTEMLEA, and subsequently, in the final rule, confirmed it. I think they recognize the utility and the importance of the drug, and we are quite pleased that becomes effective, or is scheduled to become effective on October 1. Catherine, do you want to add anything else?
Yeah, no. I think, Gregory, you explained it well. As you know, the reimbursement for these DRGs doesn't account for the new technology. With the approval of YARTEMLEA and its use in this condition, CMS has to add this on. Again, we submitted the application, proposed the add-on payment, and we're pleased with the result that we got in terms of what they'll be including for the use of YARTEMLEA.
Thank you. Steve, did that answer?
Perfectly on both counts. Thank you, and again, congrats on these strong numbers.
Yes. Thank you. We're all pleased, and we look forward to the continued growth.
Your next question comes from the line of Samuel Rodriguez Santiago with Cantor Fitzgerald. Your line is open. Please go ahead.
Hey, this is Samuel on for Olivia. Quick question. Since you mentioned the adults are making up 75% of the orders now, have you seen a difference in the amount of vials used per patient?
Samuel, to, I think our collective knowledge, no. We don't really have great visibility into vial utilization at specific centers, as you understand, with all of the HIPAA and confidentiality issues around patient information. We just don't get that information. But certainly, the ordering patterns are consistent across the pediatric and the adult center. I think my answer to that would be no, but let me ask Bill again, who may have information that I don't have.
No, they're not significantly different between the two. When you launch a new product into a deadly disease, you generally tend to get very severe patients at the beginning. So you may need to see a little bit more drug at the beginning, because they tend to require more medication, and I don't think that's any different between peds and adults. Over time, we expect to treat a lot more patients, with fewer vials as they start to get better at diagnosing it, treating it early, and getting better outcomes. That's really the way we expect it to go in the future.
Moving the treatment setting more toward the outpatient, Bill? Less so in the inpatient so that the response. Remember, in the absence of really an effective and safe drug, the focus on earlier and earlier treatment has not been there. In fact, the focus has been: how can we get these patients better without having to use some treatment for those patients? I think, as we spoke about during the prepared comments, we're seeing and we're certainly helping, I think, to implement a paradigm shift to earlier and earlier utilization for increasingly improved outcomes. The sooner you get to these patients, the harder you hit them with YARTEMLEA, I think the data clearly support the better they will do.
Awesome. Thank you, and congrats on the quarter.
Thank you, Samuel.
Your next question comes from the line of Serge Belanger with Needham. Your line is open. Please go ahead.
Hi, good afternoon, and thanks for taking my questions. First, on YARTEMLEA. Gregory, can you just talk about maybe the number of patients that have so far been treated with the product and, I guess, what the market share of the overall opportunity would be based on those patients? Secondly, you talked about in your prepared comments that TA-TMA is mostly a diagnosis of execution. With the shift paradigm that you're working on, what do you expect the market opportunity could be? Or what is the underdiagnosis and undertreated rate for the indication? Thank you.
Sure, Serge. Thanks for the questions. First, we can't give you any really definitive numbers on patient use because we don't have patient numbers. We see vials. We see vials that go into a center. We don't have any data beyond that, really, other than occasional anecdotal data that we may receive. We have no way of determining how many patients are being treated with those vials, where in the treatment course those patients are, et cetera. With respect to patient numbers, can't really provide that information. With respect to the prepared comment about diagnosis of exclusion, I think what clearly is meant there is prior to an approved product, prior to YARTEMLEA being available, the diagnosis of TA-TMA was quite challenging and really very diverse across centers.
Different sets of criteria being used by different centers, by different physicians, a lack of real standardization of the diagnostic criteria. Absent a really good treatment for TA-TMA, you can understand why physicians would look at a constellation of symptoms and say, "Let's rule out those things that we know we can treat, and if we can't treat those, then this is going to fall to what we'll call TA-TMA." We do believe that we are simply now scratching the surface. Again, I'll look to Bill to comment on that in just a moment, but I think our collective view on this is we're just scratching the surface. As there becomes further embedded an effective and a safe treatment for TA-TMA, the diagnosis of TA-TMA accordingly will increase. I think that the overall incidence numbers are going to continue to move north.
I think the percentage of patients who ultimately end up being diagnosed with TA-TMA as a percentage of stem cell transplantation will also increase. We're already seeing it. The latest MIDAS studies shows the incidence of TA-TMA at 56% of allogeneic transplants. I would think that there's a reasonable possibility that those percentages will increase. Again, when you have a treatment, there's a good reason to identify the disorder, and then the treatment becomes self-fulfilling for that set of diagnostic criteria. Again, let me turn this to Bill and see. Bill, what are your thoughts on this?
Yeah. I totally agree, Gregory. We're just scratching the surface. As well as we've done so far, we expect to do better in the future. Institutional organizations, large academic centers, it's very hard to get real change in an institutional center. Not because they don't want to, just because they're a huge organization, there's a lot of levers to push in order to really change the way they look at things. That could include not just P&T committees, but order sets and EMRs, the way that they diagnose TMA, it fundamentally has to change. We've made that change in some centers, but we have a lot more to go, and we think it'll get better over time, pretty consistently over time.
Great. Thank you.
There are no further questions at this time. I will now turn the call back to Dr. Demopulos for closing remarks.
Thank you, operator. Again, thank you all for joining us this afternoon. As we enter the second half of the year, YARTEMLEA has demonstrated strong commercial momentum in its first full quarter on the market. Reimbursement infrastructure continues to strengthen. Our operations generated positive cash flow in the quarter, and our recent note repurchases reduced debt and reduced potential dilution. We remain focused on execution, driving YARTEMLEA adoption in TA-TMA, advancing expansion opportunities across the MASP-2 franchise, and moving our other programs across our deep pipeline forward. We have a number of important opportunities and milestones ahead, and we look forward to updating you on our progress. Have a good evening. Thank you.
This concludes today's call. Thank you for attending. You may now disconnect.
Investor releaseQuarter not tagged2026-08-10Omeros Corporation to Announce Second Quarter Financial Results on August 12, 2026
Business Wire
Omeros Corporation to Announce Second Quarter Financial Results on August 12, 2026
SEATTLE, August 10, 2026--(BUSINESS WIRE)--Omeros Corporation (NASDAQ: OMER) today announced that it will issue its financial results for the second quarter of 2026 on Wednesday, August 12, 2026 after market close. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss recent developments and highlights as well as the Company’s financial results. Conference Call Details and Webcast Link Instructions To access the live webcast, please click here or visit the "Upcoming Events" section of the Investor Relations page of Omeros’ website. A replay of the call will be available for 90 days in the "Archived Events" section of the Investor Relations page of Omeros’ website. As Omeros continues to transition to a new earnings call platform (hosted by Q4 Inc.), please allow extra time to log in prior to the start of the call. About Omeros Corporation Omeros is an innovative biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for both large-market and orphan indications, with a focus on complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead complement inhibitor YARTEMLEA® (narsoplimab-wuug), which targets the lectin pathway’s effector enzyme MASP-2, is FDA-approved and commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients aged two years and older. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials. Under an asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), an inhibitor of MASP-3, the alternative pathway’s key activator, which is in clinical development for PNH and other alternative pathway indications, along with associated intellectual property and related assets. Omeros’ pipeline also includes OMS527, a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder, which is fully funded by the National Institute on Drug Abuse, and a growing portfolio of novel recombinant antibodies targeting multidrug-resistant organisms and novel molecular and cellular therapeutic programs for oncology. For more information about Omeros and its programs, visit www.omeros.com. View so…Read full documentShow less
SEATTLE, August 10, 2026--(BUSINESS WIRE)--Omeros Corporation (NASDAQ: OMER) today announced that it will issue its financial results for the second quarter of 2026 on Wednesday, August 12, 2026 after market close. Omeros management will host a conference call and webcast that same day at 4:30 p.m. Eastern Time (1:30 p.m. Pacific Time) to discuss recent developments and highlights as well as the Company’s financial results. Conference Call Details and Webcast Link Instructions To access the live webcast, please click here or visit the "Upcoming Events" section of the Investor Relations page of Omeros’ website. A replay of the call will be available for 90 days in the "Archived Events" section of the Investor Relations page of Omeros’ website. As Omeros continues to transition to a new earnings call platform (hosted by Q4 Inc.), please allow extra time to log in prior to the start of the call. About Omeros Corporation Omeros is an innovative biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for both large-market and orphan indications, with a focus on complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead complement inhibitor YARTEMLEA® (narsoplimab-wuug), which targets the lectin pathway’s effector enzyme MASP-2, is FDA-approved and commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients aged two years and older. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials. Under an asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), an inhibitor of MASP-3, the alternative pathway’s key activator, which is in clinical development for PNH and other alternative pathway indications, along with associated intellectual property and related assets. Omeros’ pipeline also includes OMS527, a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder, which is fully funded by the National Institute on Drug Abuse, and a growing portfolio of novel recombinant antibodies targeting multidrug-resistant organisms and novel molecular and cellular therapeutic programs for oncology. For more information about Omeros and its programs, visit www.omeros.com. View source version on businesswire.com: https://www.businesswire.com/news/home/20260810397824/en/ Contacts Jennifer Cook WilliamsCook Williams Communications, Inc.Investor and Media [email protected]
Investor releaseQuarter not tagged2026-06-01Omeros (OMER) Q4 2025 Earnings Transcript
Motley Fool
Omeros (OMER) Q4 2025 Earnings Transcript
Image source: The Motley Fool. Tuesday, March 31, 2026 at 4:30 p.m. ET Chairman & Chief Executive Officer — Gregory Demopulos Chief Accounting Officer — David Borges Chief Commercial Officer — Nadia Dac Chief Medical Officer — Dr. Andreas Grauer Chief Regulatory Officer — Dr. Cathy Melfi Vice President of Clinical — Dr. Steve Whitaker Need a quote from a Motley Fool analyst? Email [email protected] Gregory Demopulos: Thank you, Jennifer, and good afternoon, everyone. Joining me today are David Borges, our Chief Accounting Officer. Nadia Dac, Chief Commercial Officer; Dr. Andreas Grauer, Chief Medical Officer; Dr. Cathy Melfi, Chief Regulatory Officer; and Dr. Steve Whitaker, Vice President of Clinical. Two major successes made the fourth quarter of 2025 a turning point for Omeros. On November 25, we closed our previously announced asset purchase and license transaction with Novo Nordisk for our Phase III ready asset, zaltenibart. Then on December 23, we received FDA approval for narsoplimab now commercialized under the brand name YARTEMLEA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA. Through the zaltenibart deal, Novo Nordisk received exclusive global rights to develop and commercialize zaltenibart, Omeros' proprietary human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 or MASP-3 and a small number of target-related very early-stage antibodies and antigen binding fragments. MASP-3 is the key activator and is widely considered the premier target of the alternative pathway of complement. Omeros retains rights to its MASP-3 small molecule program, including the ability to develop and commercialize small molecule MASP-3 inhibitors across a range of therapeutic areas, including, but not limited to, ophthalmology, neurology, gastrointestinal disorders, dermatology, musculoskeletal diseases and oncology. Omeros also retains rights to its grandfathered MASP-3 antibodies with temporal and indication restrictions on commercialization and for use in advancing its small molecule therapeutics. The transaction resulted in an upfront cash payment to Omeros of $240 million with an additional $100 million in achievable near-term milestones. We're also eligible for another $410 million in onetime development and approval milestone payments and up to $1.3 billion in onetime sales and comm…Read full documentShow less
Image source: The Motley Fool. Tuesday, March 31, 2026 at 4:30 p.m. ET Chairman & Chief Executive Officer — Gregory Demopulos Chief Accounting Officer — David Borges Chief Commercial Officer — Nadia Dac Chief Medical Officer — Dr. Andreas Grauer Chief Regulatory Officer — Dr. Cathy Melfi Vice President of Clinical — Dr. Steve Whitaker Need a quote from a Motley Fool analyst? Email [email protected] Gregory Demopulos: Thank you, Jennifer, and good afternoon, everyone. Joining me today are David Borges, our Chief Accounting Officer. Nadia Dac, Chief Commercial Officer; Dr. Andreas Grauer, Chief Medical Officer; Dr. Cathy Melfi, Chief Regulatory Officer; and Dr. Steve Whitaker, Vice President of Clinical. Two major successes made the fourth quarter of 2025 a turning point for Omeros. On November 25, we closed our previously announced asset purchase and license transaction with Novo Nordisk for our Phase III ready asset, zaltenibart. Then on December 23, we received FDA approval for narsoplimab now commercialized under the brand name YARTEMLEA for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy, or TA-TMA. Through the zaltenibart deal, Novo Nordisk received exclusive global rights to develop and commercialize zaltenibart, Omeros' proprietary human monoclonal antibody targeting mannan-binding lectin-associated serine protease-3 or MASP-3 and a small number of target-related very early-stage antibodies and antigen binding fragments. MASP-3 is the key activator and is widely considered the premier target of the alternative pathway of complement. Omeros retains rights to its MASP-3 small molecule program, including the ability to develop and commercialize small molecule MASP-3 inhibitors across a range of therapeutic areas, including, but not limited to, ophthalmology, neurology, gastrointestinal disorders, dermatology, musculoskeletal diseases and oncology. Omeros also retains rights to its grandfathered MASP-3 antibodies with temporal and indication restrictions on commercialization and for use in advancing its small molecule therapeutics. The transaction resulted in an upfront cash payment to Omeros of $240 million with an additional $100 million in achievable near-term milestones. We're also eligible for another $410 million in onetime development and approval milestone payments and up to $1.3 billion in onetime sales and commercial milestones. All told, the deal is valued at up to $2.1 billion in upfront and milestone payments. On top of that, Omeros is set to receive tiered royalties up to the high teens on net sales of commercialized products. As part of the transaction, we entered into a transition services agreement, or TSA, with Novo Nordisk. Under this TSA, we are providing and being reimbursed by Novo Nordisk for our employee costs and other expenses associated with services to facilitate the transfer and to maintain the continuous operation of zaltenibart studies and programs. Novo Nordisk will also reimburse Omeros for its inventories of zaltenibart drug substance and drug product. Our partnership with Novo Nordisk is mutually beneficial, underscoring the value of Omeros' science and development expertise while providing us with substantial and ongoing working capital and enabling Novo Nordisk to lever its extensive experience and global reach to unlock the full potential of zaltenibart. Novo plans to advance zaltenibart across PNH and multiple other indications. The ultimate beneficiaries will be patients. Omeros' second landmark achievement in the fourth quarter of '25 was FDA's late December approval of YARTEMLEA, Omeros' lead MASP-2 inhibitor, making YARTEMLEA the first and only approved treatment for TA-TMA. MASP-2 is the effector enzyme of the lectin pathway of complement in TA-TMA and often fatal complication of stem cell transplantation is driven by lectin pathway activation. The FDA-approved indication for YARTEMLEA is broad, covering all TA-TMA in both adults and children at least 2 years of age. Unlike C5 and C3 inhibitors sometimes used off-label, YARTEMLEA by blocking upstream MASP-2 preserves the infection fighting functions of the classical and alternative pathways of complement. This important mechanistic benefit is reflected in YARTEMLEA's approved label, in which there are none of the safety-related obligations usually required for complement inhibitors. Specifically, no box warning, no risk evaluation and mitigation strategy or REMS program and no required vaccinations. As previously disclosed, we began preparations for the U.S. commercial launch of YARTEMLEA well before receiving approval, allowing us to hit the ground running. We've hired and deployed our entire field force of account managers and directors, market development managers, market access leads and medical science liaisons across all territories. Having supplied our distributors within the first 3 weeks of January, first sales occurred shortly thereafter. Within 24 hours of placing an order, both adult and pediatric TA-TMA patients are now receiving YARTEMLEA, including patients who have recently failed prior off-label C5 or C3 inhibitor regimens. Patients are receiving YARTEMLEA in both hospital and outpatient settings and third-party payer reimbursement has been received. The per vial price for YARTEMLEA is approximately $36,000. Each vial represents a single dose. Across the pivotal clinical trial and the expanded access program, median utilization was 8 to 10 vials per treatment course. We expect the majority of the TA-TMA patients course to be administered in hospital outpatient departments where the drug typically is purchased and billed by the hospital. With our field force fully deployed, we remain focused on the 80 highest volume transplant centers across the country. Those 80 centers represent approximately 80% of annual stem cell transplants in the U.S. At this early stage, our primary launch objectives are fourfold: First, to educate the entire transplant care team, including transplant physicians, nurses, pharmacists and reimbursement teams regarding the recently harmonized TA-TMA diagnostic criteria, thereby driving awareness, early diagnosis and treatment of the disorder. On that front, beyond the 80 highest volume transplant centers, our field force has actively met with and detailed centers representing nearly 90% of the allogeneic stem cell transplant procedures performed nationally. Second, to support transplant centers in quickly obtaining their pharmacy and therapeutics or P&T committee approvals, adding YARTEMLEA to their formularies and streamlining their ordering processes to continue ensuring seamless access to YARTEMLEA in both the hospital and outpatient settings. Our progress has exceeded our expectations. YARTEMLEA has obtained P&T committee approval and is now on formulary at 50% of the top 10 U.S. transplant centers, 40% of the top 20 centers, 35% of the top 40 centers and approximately 30% of the top 80 transplant centers across the country. Third, to work with third-party payers to continue ensuring timely reimbursement consistent with the YARTEMLEA label and published diagnostic criteria. To date, third-party payers have approved all pre-authorization requests for YARTEMLEA, meaning that insurers have agreed to prospectively cover those patients. Fourth, to finalize the Health Economics and Outcomes Research or HEOR analysis using the uniformly strong clinical efficacy data and favorable safety profile of YARTEMLEA to demonstrate its compelling cost effectiveness to health care providers and payers. We plan to publish the HEOR analysis for YARTEMLEA soon, and the results strongly support YARTEMLEA's clinical, economic and real-world value. We look forward to providing additional detail regarding the launch of YARTEMLEA during our upcoming earnings call for the first quarter of 2026. Beyond the U.S., our marketing authorization application for YARTEMLEA in TA-TMA is pending with the European Medicines Agency. We continue to expect a decision midyear. For commercialization of YARTEMLEA outside the U.S., we are evaluating potential partnerships, both broad ex-U.S. arrangements and regional collaborations. We believe that these opportunities are substantial. As we have discussed in previous calls, the underlying biology of TA-TMA, endothelial injury and cellular damage spans a broad range of therapeutic areas. For YARTEMLEA, we are evaluating expansion opportunities in additional indications, including acute respiratory distress syndrome or ARDS, solid organ transplant-related TMA and other endothelial injury-related disorders. We also intend to advance our once-quarterly dosed MASP-2 antibody, OMS1029, which is Phase II ready as well as our MASP-2 small molecule program designed for once-daily oral administration. We expect that both our long-acting antibody, OMS1029 and our small molecule inhibitor programs are well suited for chronic indications, including those in nephrology and in neurology. Let's now examine our fourth quarter and full year 2025 financials. For the fourth quarter, Omeros reported net income of $86.5 million or $1.22 per share compared to the third quarter's net loss of $30.9 million or a loss of $0.47 per share. Fourth quarter results include a net gain of $237.6 million resulting from the zaltenibart transaction with Novo Nordisk. In the fourth quarter, Omeros also incurred a $136 million noncash charge associated with the mark-to-market adjustment on the embedded derivatives related to our 2029 convertible notes and term loan. Excluding this charge, our fourth quarter non-GAAP adjusted net income was $222.5 million and our fourth quarter non-GAAP adjusted income per share was $3.14. Further strengthening our balance sheet in the fourth quarter in November, we used a portion of our $240 million upfront payment from Novo Nordisk to repay in full our $67.1 million secured term loan. Last month, we used another portion of the upfront to repay at maturity the remaining $17.1 million principal balance on our 2026 convertible notes. As a result, all indebtedness under our senior secured term loan and 2026 notes has been extinguished, leaving us with only a $70.8 million principal amount outstanding in 2029 convertible notes. As of December 31, 2025, we had $171.8 million in cash and investments, an increase of $135.7 million from the quarter ended September 30, 2025. We anticipate that the YARTEMLEA program will be financially self-sustaining this year, and we expect the company to achieve positive cash flow in 2027. Let's turn now to development programs beyond our complement franchise. Our PDE7 inhibitor program evaluating OMS527 for cocaine use disorder is fully funded by a grant from the National Institute on Drug Abuse or NIDA. Animal cocaine interaction studies designed with NIDA toxicologists were completed and showed no drug interaction or safety issues, supporting the scheduled inpatient human study in cocaine users. FDA subsequently requested additional preclinical information before initiation of the inpatient study. Together with our collaborators at NIDA, we are scheduled to meet with FDA in the coming quarter to discuss that request. Our targeted complement activating therapy or T-CAT platform has also made substantial strides. Our T-CAT platform represents a novel class of pathogen targeting recombinant antibodies designed for broad use against diverse pathogens, including multidrug-resistant organisms or MDROs. MDROs are predominantly bacteria that are resistant to antimicrobial agents and are rapidly becoming a global threat. In 2024, sales of anti-infectives were $46 billion in the U.S. alone and $135 billion globally. Over the next 25 years, more than 39 million people worldwide are estimated to die from MDR bacteria alone. Unlike marketed antimicrobials, T-CAT is designed to kill pathogens regardless of resistance profile without promoting resistance. In well-established in vivo animal models considered predictive of efficacy in humans, T-CAT recombinant antibodies demonstrated effectiveness in treating life-threatening infections caused by both gram-negative and gram-positive bacteria, including those designated by the World Health Organization as priority pathogens. Patents have now been filed and a publication on our T-CAT platform is expected in the coming weeks. Finally, our oncology platform continues to progress rapidly. IND-enabling studies are underway for OncotoX-AML, our biologic agent designed to treat acute myeloid leukemia or AML. AML is an aggressive and often fatal bone marrow and blood cancer. OncotoX-AML has shown broad application across AML genotypes, including historically difficult-to-treat mutations like TP53, NPM1, KMT2A and FLT3. These genetic mutations are collectively found in approximately 90% of AML patients. Across human tumor-bearing animal and in vitro human AML cell line studies, OncotoX-AML has consistently shown superior efficacy to current AML standard of care treatments. In a pilot study assessing the efficacy and safety of OncotoX-AML in nonhuman primates, a single course of OncotoX-AML resulted in selective, reversible and dose-related killing of myeloid progenitor cells, the cells that can mutate and lead to AML by up to 99%. OncotoX-AML was tolerated with no safety signal of concern. Together with our clinical steering committee comprised of AML experts from leading academic cancer centers, we are designing our first-in-human clinical trial targeted for late next year. That concludes our financial corporate and development update. And I'll now turn the call over to David Borges, our Chief Accounting Officer, for a detailed discussion of our financial results. David? David Borges: Thanks, Greg. Net income for the fourth quarter of 2025 was $86.5 million or $1.22 of net income per share compared to a net loss of $30.9 million or $0.47 net loss per share in the third quarter of 2025. Fourth quarter results include a net gain of $237.6 million on the sale of zaltenibart to Novo Nordisk, which I will discuss in more detail in a moment. Results also include a $136 million noncash charge associated with the mark-to-market adjustment on the embedded derivatives related to our 2029 convertible notes and term loan. Excluding this charge, non-GAAP adjusted net income for the quarter was $222.5 million and non-GAAP adjusted net income per share was $3.14. This charge represents a noncash remeasurement adjustment and excluding it, provides a clearer view of the company's operating performance during the quarter. As of December 31, 2025, we had $171.8 million of cash and investments on hand. This balance includes the gross proceeds of the $240 million upfront payment received from Novo Nordisk in connection with the sale of zaltenibart and the full repayment of our $67.1 million term loan in the fourth quarter. In connection with the repayment of the term loan, all liens and covenants associated with the credit agreement, including the $25 million minimum liquidity covenant were eliminated. In February 2026, we repaid at maturity the remaining $17.1 million principal balance on our 2026 notes. Following these repayments, our only remaining debt is a $70.8 million in principal amount of unsecured 2029 convertible notes, which are not due until June 2029. Costs and expenses from continuing operations for the fourth quarter before interest and other income were $29.1 million, an increase of $2.7 million from the third quarter of 2025. Research and development expenses in the fourth quarter were primarily focused on YARTEMLEA and zaltenibart. Interest expense in the fourth quarter was $8.7 million. The primary components of interest expense include the DRI royalty obligation, the 2029 notes, the 2026 notes and the term loan. Excluding the DRI OMIDRIA royalty obligation, which represents pass-through interest from Rayner to DRI and has no economic impact to us, as well as noncash amortization of debt issuance costs, discounts and premiums, contractual cash interest expense was $3.2 million compared to $4.2 million in the prior quarter, a decrease of $1 million. The decrease was primarily due to the repayment of the term loan in November 2025. In connection with the closing of the sale of zaltenibart to Novo, we recognized a net gain of $237.6 million. This reflects the $240 million upfront payment less $2.4 million in transaction costs. Concurrent with the closing of the transaction, we entered into a transition services agreement with Novo Nordisk to facilitate the transfer of acquired assets and liabilities and support the continued operation of relevant studies and program activities. Costs incurred by the company under the transition services agreement, including third-party expenses and internal FTE costs are expected to be reimbursed by Novo. Interest and other income totaled $1.1 million in the fourth quarter compared to $616,000 in the third quarter of '25, primarily reflecting higher average cash balances. In connection with the repayment of the term loan in November '25, we recognized a $17 million noncash gain related to the derecognition of the remaining unamortized premium. This was a onetime accounting adjustment associated with the repayment of the loan. And during the fourth quarter, we reported $135 million noncash loss on the mark-to-market adjustment on the embedded derivative related to our 2029 convertible notes. The change in valuation was primarily driven by the increase in our stock price during the quarter, which rose from $4.10 per share at September 30, '25 to $17.18 per share at December 31, '25. This embedded derivative reflects certain features of the notes, including the conversion option and interest make-whole provisions available to noteholders. Because the valuation of this derivative is influenced by our stock price and other market inputs, it can introduce significant volatility in our reported results from quarter-to-quarter. This adjustment is noncash and does not affect our operating performance or liquidity. As a result, we present non-GAAP adjusted net income and net loss to exclude the noncash nature of these volatile swings. Income from discontinued operations in the fourth quarter was $6.6 million, an increase of $16.2 million from the third quarter. The increase primarily reflects the absence of a large noncash remeasurement expense recorded in the third quarter following a downward revision of the forecast for U.S.-based OMIDRIA royalties. Now let's look at our expected first quarter 2026 results. We anticipate that overall operating expenses from continuing operations in the first quarter of '26 will be comparable to the fourth quarter of '25. Research and development expenses are expected to be lower as zaltenibart-related expenses will be reimbursed under the transition services agreement with Novo. Sales and marketing expenses are expected to increase in the first quarter, reflecting costs associated with building our commercial infrastructure, including the hiring of a field sales force, marketing expenses and other commercial launch activities for YARTEMLEA. As YARTEMLEA is in the early stages of launch, we are not providing revenue guidance at this time. We typically do not provide guidance following a new product launch while the market access and physician adoption are developing until -- and until we're able to estimate revenue with greater accuracy. In the near term, we're focused on building physician awareness, expanding disease education and working with third-party payers to ensure timely reimbursement. Interest and other income are expected to be slightly higher than in the fourth quarter of 2025, primarily reflecting higher average cash balances. Interest expense is expected to be approximately $8.1 million, reflecting the reduction in our outstanding debt and excluding any potential noncash adjustments related to the OMIDRIA royalty obligation. Income from discontinued operations is expected to be in the $5 million to $6 million range, again, excluding any noncash remeasurement adjustments related to the OMIDRIA contract royalty asset. And finally, one thing to keep in mind is that our reported results will continue to reflect mark-to-market adjustments on the embedded derivative tied to our 2029 convertible notes. These adjustments generally move with our stock price and can create significant volatility from quarter-to-quarter. Because these adjustments are noncash and unpredictable, we present non-GAAP adjusted net income and loss measures, and they do not affect our operating guidance. And with that, I'll turn it back over to Greg. Gregory Demopulos: Thanks, David. Operator, please, would you open the call to questions. Operator: [Operator Instructions] Your first question comes from the line of Brandon Folkes with H.C. Wainwright. Brandon Folkes: Congrats on all the progress. Maybe just 2 from me. How should we think about the progress of formulary additions across the top 80% of transplant centers in 2026? Obviously, you got off to a strong start there. So just sort of how should we think about the progress for the rest of the year? And then secondly, I know it's very early on in the YARTEMLEA launch, so kind of asking this with an asterisks. But any color on the real-world vial usage to date? Sort of any early data suggesting a different number of vials in the real world versus what we saw in the clinical data? Gregory Demopulos: Brandon, thanks. With respect to the first question, we're quite pleased with the P&T committee approvals that we've received so far that YARTEMLEA has received. It was really ahead of schedule, which I think indicates the strong interest and frankly, the recognized need for the drug. I expect -- I think we expect that we will continue to see additional P&T approvals over the next several months. And our objective, of course, is to have P&T committee approvals across all of the top 80 and frankly, beyond the top 80 sites. But I'll check with Nadia. Nadia, do you have any additional thoughts on that? Nadia Dac: Yes, I completely agree with everything you said, Greg. And I will underscore how pleased we are with the speed with which these P&T decisions are being taken, which isn't always the case in a launch. Here, they're seeing the value and the urgency to treat patients with YARTEMLEA's value proposition. And I will add that in places where we don't have P&T approval yet, if it's still underway, it's not standing in the way of getting YARTEMLEA to the patients. And so we are seeing the use of YARTEMLEA in the hospitals even without a P&T approval in place. Gregory Demopulos: I would just underscore that latter point from Nadia, which is despite in some of these centers not having P&T approval yet, we continue to see requests and sales of YARTEMLEA, use of YARTEMLEA for the benefit of the patients in those centers. So it's really been very encouraging and frankly, validating on what we believe the importance and the need for YARTEMLEA is in these patients, both adult and pediatric, really both in the hospital setting and in the outpatient setting. Your second question, Brandon, was tied to vial usage. And I assume you're asking whether it's once weekly, twice weekly, but let me just make sure I understand the question. Brandon Folkes: Yes. Ideally. Just anything you're learning early on in the launch, which may be different to what we saw in the clinical data? Gregory Demopulos: Yes, not really different. We are seeing once weekly and twice weekly usage right now, at an estimate, the split is about 70% once weekly, 30% twice weekly, twice weekly being more common in the pediatric patients than in the adult patients. We do expect that shift to move more heavily toward twice weekly dosing. Really what needs to occur and what our field force is doing is educating the transplant teams on their ability to dose twice weekly. It is allowed under our label. And I think that, that information is being really well received by the transplant teams across the centers nationally. And so I would expect that we would see that split to move more heavily toward twice weekly dosing. But again, I'll ask Nadia her thoughts on this. Nadia Dac: Yes, absolutely. And one of the execution tactics and the messaging that the field is focused on is the sense of urgency and not to wait because our label allows twice weekly dosing. And so in several instances, we're seeing that there is an urgency to treat and move a little faster if they need it for the patients. And the other thing that's very encouraging is the published policies that we've seen to date with third-party payers are, they're supporting prior authorization to label. And so it's not restricting the use of twice weekly dosing as needed. Gregory Demopulos: Does that help, Brandon? Brandon Folkes: Very helpful. Congrats on the early launch progress. Gregory Demopulos: Thank you. Operator: Your next question comes from the line of Olivia Brayer with Cantor. Samuel Rodriguez: This is Sam on for Olivia. I have a quick one on -- you mentioned that you plan to be financially sustainable this year and then cash flow positive by 2027. Is that implying that you received the $100 million from Novo and you had to pay the 29 notes? And then under YARTEMLEA launch, what feedback have you gotten from the sales force when educating the teams? And has there been any like pushback or like what kind of roadblocks or things have you seen that you expect to like smooth out by the rest of the year? Gregory Demopulos: Sam, with respect to your first question, the comment about self-sustainability was really directed at the YARTEMLEA business in 2026, meaning the business itself would be self-sustaining in 2026. 2027 is our target for company positive cash flow. So I'm hoping that, that helped and cleared up any misunderstanding. Samuel Rodriguez: Yes. That's awesome. And then on YARTEMLEA, what kind of bumps in the road have you encountered? And what can you do to like smooth those out? Gregory Demopulos: Yes. Again, we'll get into this more in our Q1 call, which will be in about 6 weeks. But I can tell you that our sales team is really very excited, very enthusiastic about the responses that they are receiving from the medical centers that they're detailing. And as I said, we are -- we've been in already sites that represent about 90% of the allogeneic transplants done nationally every year. So the response has been from those centers really uniformly positive. I think that -- there's an education process that's going on. But the eagerness to learn the recognition of the urgency and the need for YARTEMLEA and the benefits with the really quite favorable safety profile, I think, is resonating very strongly with the sites, really all the sites that I am aware of have been very receptive. But again, I'll turn it to Nadia and see if she has more information on that. Nadia Dac: Yes. The receptivity has been extremely positive. Our value proposition is viewed as significant and addressing an unmet need. And I will say that all of the effort we put into the prelaunch period of educating on TA-TMA, the signs of symptoms to identify it and the urgency to treat, we're seeing the payoff of that education. And so now with the first and only approved product for TA-TMA, that sense of urgency is playing out. And if I were to pick on anything that we want to smooth out, what we're working on as a commercial team is to make sure that we have even more education out there that supports our on-the-ground efforts and seeing how we can do more through nonpersonal efforts because as we see, the patient can come from anywhere, 175 centers. So we want to make sure that we're supporting any of the HCPs out there that are looking for treatment and wanting to learn more about YARTEMLEA. Gregory Demopulos: And I would agree with what Nadia said that really we're focused on educating. But I've been personally quite impressed by the steep upswing of that education across all of these sites. They understand it, they get it. And as Nadia said, they're quite receptive to the value proposition here for their patients. I mean this is a drug that works well. And when you look at the safety profile, that's quite a favorable benefit risk profile that I think YARTEMLEA represents. Samuel Rodriguez: And if I can squeeze one last one in. Regarding the EMA decision by midyear and like partnership discussions, do you expect any impact from MFN and like ex U.S. pricing? Gregory Demopulos: Yes. It's too early right now to discuss what we expect with respect to pricing in the EU. We are really sort of laser-focused on achieving that approval. There is, as you know, no approved treatment other than narsoplimab or YARTEMLEA anywhere in the world, and that includes Europe. So I think it is a needed product. We see the interest in it to be high as was clearly evident at the recent EBMT meeting, the European Blood and Marrow Transplantation meeting. The interest in YARTEMLEA there was very high. And our focus is getting it approved, making it available for European patients as we've already made it available through our expanded access program. Operator: Your next question comes from the line of Steve Brozak with WBB. Stephen Brozak: I'd like to go back to something you raised on the last series of questions in terms of the value proposition. I mean, given your compassionate use programs and all the drug that you've given out and all the literature that's been published, I'm certain that the hem-oncs are very, very familiar with YARTEMLEA. But can you go into as much detail as possible as to the value proposition because these are sick patients, of course. But a lot of resources have been expended on them financially and obviously, in the medical care. Can you tell us about that? Because I'd like to put into perspective the criticality of what has just been done and what you're now doing. And I've got a follow-up after that, please. Gregory Demopulos: Steve, yes, with respect to the value proposition, I think I mentioned or I know I mentioned in the prepared remarks, the work we're doing on HEOR, on the Health Economics and Outcomes Research, and we'll be publishing. We plan to publish those analyses soon, but they're compelling. I think they make a very clear case for the economic, clinical and really, as I said, real-world benefits of YARTEMLEA. So we think that there is obviously a strong case to be made, and we are making it, and we'll be publishing that. So did that answer your question? Or was it something additional? Stephen Brozak: No, no. It's answered the question, but frankly, I was looking more for dollars and cents as to the scale order of magnitude when you're seeing these transplant patients, those are not just critical procedures, but they're also very, very expensive. Can you give us an idea of what we're looking at as far as what patients or the insurers, the hospital systems are spending right now? And also, I know this has been the classical unmet need, but what were some of the products that were used before in the order of magnitude and frankly, they were spending and where they really weren't working. If you could give us anything there, and I've got one more again after. Gregory Demopulos: Sure. Well, look, the overall transplant cost and related costs run about $1 million. So you spend a lot of money, you spend a lot of time, energy, there's a lot of patient involvement, patient family involvement. And then TMA hits, right? And it is really unpredictable. You cannot -- there's no test that will tell you this patient versus another patient is going to have a TA-TMA. So I think what I want to be careful about is speaking directly to numbers. With respect to your question about what has been used previously. Well, we know that off-label C-5 and to a much lesser extent, C-3 inhibitors have been used. You know the costs associated with those. Those are quite public. What we do know and what we're seeing in the published literature out of Memorial Sloan Kettering directed to adults, out of Emory directed to children, really now controlled trials with specifically in these cases, C-5 inhibition. But what we have seen and what have been -- what has been published is the markedly increased infection rate associated with C-5 inhibition, I mean up to a sixfold increase in infection-related mortality as reported in this set of publications. So that carries, I think, a significant cost beyond the cost of the agents themselves. So we think that where we are priced, the economic value proposition for narsoplimab or YARTEMLEA is really quite clear. And then when you layer on the clinical benefits of that, it becomes really something that I think is pretty compelling. Is that addressing your question, Steve? Stephen Brozak: Absolutely. Okay. A follow-up. You've been very transparent in saying that the hem-oncs, the hematological oncologists have been accepting YARTEMLEA. Question I've got for you is, since it is obviously a critical mishap, how fast are you in being able to respond? Because part of this is obviously being able to get the drug to the patients, but how quick can you respond to these clinicians who are obviously watching their patients deteriorate, but that those first few days are critical in understanding it. How -- what feedback can you give us there? And I'll hop back in the queue. Gregory Demopulos: Sure. Well, as we have set up our distribution channels, we can deliver drug. We are delivering drug within 24 hours of the request. So we can reach the site very quickly, which, of course, is the objective, right? Our preference would be not to wait until the patient is severely or critically ill, as you just noted, but to move it upstream temporarily, right, to be able to treat patients earlier, jump on it quickly, jump on it hard, meaning appropriately dosing. And in that way, really bring the full effect of narsoplimab or YARTEMLEA to these patients. That's the objective. That's what we've -- that's the purpose behind establishing really 24-hour delivery of the drug. Request comes in, drug goes out. And I think the effects of that we're seeing, and I think we'll continue to see. Nadia, do you have something you'd like to add to that? Nadia Dac: Yes, absolutely. So even before the shipment goes out, if there's any questions or any support that they need with the prior authorization, we have our team on the ground that will either go there in person or jump on a Zoom and address those questions, whether it be our reimbursement manager, our account manager or our MSLs. So we have a model that is designed to act immediately, and we have multiple examples of that. In addition to the 800 number that we have, our in-person phone calls that come in, we jump on that immediately and then drug is delivered within 24 hours. Gregory Demopulos: And with respect to what Nadia just said about pre-authorizations, as I mentioned in the prepared comments, all pre-authorization requests have been approved by the third-party payers. So we're quite pleased with -- we're quite early in this launch. Our launch was really January. And here we are at the end of March, talking pharmacy and therapeutic committee approvals. And to the extent that we have we're very pleased. And we think those are going to continue to move through. Remember, I've given you those that are already approved. I did not mention those that are actively in process for being approved. And those numbers are even substantially higher than what I just gave you. So we're really quite pleased by that and look forward to sharing additional information at our Q1 call. Speaker. Stephen Brozak: Congrats on, obviously, the developments of 2025 and what you've just told us about Q1. Operator: Your next question comes from the line of Serge Belanger with Needham. Serge Belanger: Greg, you mentioned all requests for access to YARTEMLEA have been granted. Just curious if these were via medical exceptions or there's formal formulary coverage for the product at this point? And then since we're at the last day of the quarter, 1Q here, is it too early to talk about how many patient starts we've seen so far that have started treatment on the product? Gregory Demopulos: And the second question I broke up a little bit was how the response has been to the drug? Serge Belanger: No. The second question was since we're on the last day of the first quarter, whether it was too early to start -- to get an idea of how many patient starts you have seen so far on the product. Gregory Demopulos: You're asking about numbers. Right. We aren't going to provide those today, Serge. We'll be talking about those, obviously, in the Q1 call. But I think we've given you color as to how we see the launch going with respect to your first question, let me turn that over to Nadia. Nadia Dac: Yes. So the question is about the PA approval and whether those were handled by medical exception or by policy. The answer is both. And what's really encouraging is, as many of you probably can see, there are published policies already for YARTEMLEA in the public domain and that they are PA to label. And in the places where we don't see a published policy yet, they are being handled by medical exception, also PA to label. Our intent going into the launch, we built a strategy where we would have policies that are PA to label, and that is playing out. And we have a strong national account manager team that is following up with any of the payer requests for in-services, presentations and the value narrative that we spoke about earlier is going to be very critical to those conversations. But we are very encouraged and really strong success to date. Serge Belanger: Great. And Greg, regarding the $100 million milestone that you described as near term from Novo. I guess just how confident are you in this -- in receiving this milestone? And can you give us color on what triggers it? Gregory Demopulos: Yes. We are, by agreement with Novo Nordisk, not able to specify what those -- that collection of milestones ties to. But I will tell you that we're confident around the receipt of those. Again, I can never guarantee these things, but I think our level of confidence is high. Operator: There are no further questions at this time. I will now turn the call back to Dr. Demopulos for closing remarks. Gregory Demopulos: Thank you, operator. Thank you all for joining this afternoon. 2025 ended strong, and 2026 has continued that momentum. The strategy we set for the company is playing out, and we are well positioned now for success. We look forward to speaking with all of you again in about 6 weeks when we'll provide a more detailed update on our YARTEMLEA launch. We appreciate your continued support, and have a good evening. Operator: This concludes today's call. Thank you for attending. You may now disconnect. Before you buy stock in Omeros, consider this: The Motley Fool Stock Advisor analyst team just identified what they believe are the 10 best stocks for investors to buy now… and Omeros wasn’t one of them. The 10 stocks that made the cut could produce monster returns in the coming years. 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As with all our articles, The Motley Fool does not assume any responsibility for your use of this content, and we strongly encourage you to do your own research, including listening to the call yourself and reading the company's SEC filings. Please see our Terms and Conditions for additional details, including our Obligatory Capitalized Disclaimers of Liability. The Motley Fool has no position in any of the stocks mentioned. The Motley Fool has a disclosure policy. Omeros (OMER) Q4 2025 Earnings Transcript was originally published by The Motley Fool
Investor releaseQuarter not tagged2026-05-14Omeros Corp (OMER) Q1 2026 Earnings Call Highlights: Strong YARTEMLEA Launch and Strategic ...
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Omeros Corp (OMER) Q1 2026 Earnings Call Highlights: Strong YARTEMLEA Launch and Strategic ...
This article first appeared on GuruFocus. YARTEMLEA Gross Revenues: $11.1 million in the first quarter. YARTEMLEA Net Revenues: $9.9 million, reflecting gross-to-net adjustments of approximately 11%. Net Income: $56.1 million or $0.78 per share, including a $73.1 million non-cash mark-to-market gain. Adjusted Net Loss: $17.1 million or $0.24 per share, excluding non-cash items. Cash and Investments: $135.3 million as of March 31, 2026. Share Repurchase: Approximately 360,000 shares repurchased at an average price of $11.70 per share, totaling $4.2 million. Upfront Cash from Novo Nordisk Deal: $240 million received. Interest Expense: $5.9 million in the first quarter. Interest and Other Income: $1.5 million in the first quarter. Operating Expenses: $27.3 million for the first quarter before interest and other income. Warning! GuruFocus has detected 2 Warning Sign with OMER. Is OMER fairly valued? Test your thesis with our free DCF calculator. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Omeros Corp (NASDAQ:OMER) successfully launched YARTEMLEA, the first and only approved treatment for TA-TMA, generating $11.1 million in gross revenues and $9.9 million in net revenues in the first quarter. The company received $240 million in upfront cash from a transaction with Novo Nordisk, with potential for an additional $100 million in near-term milestone payments. YARTEMLEA has been adopted by 30 unique accounts, with significant uptake in major transplant centers, indicating strong early demand. The FDA approval of YARTEMLEA and the assignment of a Permanent Healthcare Common Procedure Coding System (J-code) by CMS are expected to simplify billing and reimbursement, enhancing patient access. Omeros Corp (NASDAQ:OMER) is expanding its MASP-2 program and exploring additional indications for YARTEMLEA, including ARDS and sickle cell disease, which could broaden its market potential. Despite the positive launch of YARTEMLEA, Omeros Corp (NASDAQ:OMER) reported a non-GAAP adjusted net loss of $17.1 million for the first quarter. The company faces volatility in its financial results due to non-cash mark-to-market adjustments on embedded derivatives, which can significantly impact reported earnings. Omeros Corp (NASDAQ:OMER) is still in the early stages of YARTEMLEA's launch, with no revenue gui…Read full documentShow less
This article first appeared on GuruFocus. YARTEMLEA Gross Revenues: $11.1 million in the first quarter. YARTEMLEA Net Revenues: $9.9 million, reflecting gross-to-net adjustments of approximately 11%. Net Income: $56.1 million or $0.78 per share, including a $73.1 million non-cash mark-to-market gain. Adjusted Net Loss: $17.1 million or $0.24 per share, excluding non-cash items. Cash and Investments: $135.3 million as of March 31, 2026. Share Repurchase: Approximately 360,000 shares repurchased at an average price of $11.70 per share, totaling $4.2 million. Upfront Cash from Novo Nordisk Deal: $240 million received. Interest Expense: $5.9 million in the first quarter. Interest and Other Income: $1.5 million in the first quarter. Operating Expenses: $27.3 million for the first quarter before interest and other income. Warning! GuruFocus has detected 2 Warning Sign with OMER. Is OMER fairly valued? Test your thesis with our free DCF calculator. Release Date: May 13, 2026 For the complete transcript of the earnings call, please refer to the full earnings call transcript. Omeros Corp (NASDAQ:OMER) successfully launched YARTEMLEA, the first and only approved treatment for TA-TMA, generating $11.1 million in gross revenues and $9.9 million in net revenues in the first quarter. The company received $240 million in upfront cash from a transaction with Novo Nordisk, with potential for an additional $100 million in near-term milestone payments. YARTEMLEA has been adopted by 30 unique accounts, with significant uptake in major transplant centers, indicating strong early demand. The FDA approval of YARTEMLEA and the assignment of a Permanent Healthcare Common Procedure Coding System (J-code) by CMS are expected to simplify billing and reimbursement, enhancing patient access. Omeros Corp (NASDAQ:OMER) is expanding its MASP-2 program and exploring additional indications for YARTEMLEA, including ARDS and sickle cell disease, which could broaden its market potential. Despite the positive launch of YARTEMLEA, Omeros Corp (NASDAQ:OMER) reported a non-GAAP adjusted net loss of $17.1 million for the first quarter. The company faces volatility in its financial results due to non-cash mark-to-market adjustments on embedded derivatives, which can significantly impact reported earnings. Omeros Corp (NASDAQ:OMER) is still in the early stages of YARTEMLEA's launch, with no revenue guidance provided, making future financial performance uncertain. The company has significant debt obligations, with $70.8 million outstanding on its 2029 convertible notes, which could impact future financial flexibility. There is competition in the TA-TMA treatment space, with AstraZeneca conducting a Phase 3 study for a similar indication, which could affect YARTEMLEA's market position. Q: Can you detail the process and time it takes from when a clinician requests YARTEMLEA to when it is delivered to the hospital? A: The distributors deliver the drug to the sites within about 24 hours of receiving the request. The process is straightforward, with requests made to distributors who then deliver within this timeframe. - Gregory Demopulos, CEO Q: How does the pediatric patient demand for YARTEMLEA compare to the adult population in TA-TMA cases? A: The split between adult and pediatric patients in TA-TMA is roughly 85/15. However, early data shows a greater percentage of pediatric patients than expected, indicating rapid adoption across both demographics. - Gregory Demopulos, CEO Q: How are you thinking about the split between inventory, US wholesaler sales, and hospital demand for YARTEMLEA? A: Given the short delivery process of 24 hours, inventory at distributors and centers is relatively small, averaging 1 to 1.5 weeks. Specific patient numbers are not shared by centers, but we track vial distribution to centers. - Gregory Demopulos, CEO Q: What are your thoughts on AstraZeneca's ULTOMIRIS Phase 3 study in TMA and its potential impact on the landscape? A: AstraZeneca changed their endpoint from response to event-free survival after their pediatric trial showed a 17% response rate. Our understanding is that their trial involves less severe patients than ours. - Gregory Demopulos, CEO and J. Steven Whitaker, Chief Medical Officer Q: Can you elaborate on efforts to recognize TMA earlier and the potential impact of NTAP on intervention timing? A: We aim for earlier intervention to improve outcomes. The NTAP will subsidize inpatient payments, facilitating earlier treatment. There's increasing awareness in the transplant community about upstream administration of YARTEMLEA. - Gregory Demopulos, CEO For the complete transcript of the earnings call, please refer to the full earnings call transcript.
Investor releaseQuarter not tagged2026-05-14Omeros Corporation Reports First Quarter 2026 Financial Results
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Omeros Corporation Reports First Quarter 2026 Financial Results
– Conference Call Today at 4:30 p.m. ET SEATTLE, May 13, 2026--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the first quarter ended March 31, 2026, which include: First Quarter and Recent Highlights In January 2026, we launched YARTEMLEA® in the U.S. market. During the quarter, gross product sales were $11.1 million and associated net sales, after deduction of wholesaler distribution fees and chargebacks, were $9.9 million. Net income for the first quarter of 2026 was $56.1 million, or $0.78 per share, compared to a net loss of $33.5 million, or $0.58 per share, for the first quarter of 2025. First quarter results include a $73.1 million non-cash gain associated with the mark-to-market adjustment on the embedded derivatives related to our 2029 unsecured convertible notes (the "2029 Notes"). Excluding the non-cash change in our embedded derivatives, non-GAAP adjusted net loss for the three months ended March 31, 2026 was $17.1 million, or $0.24 per share. At March 31, 2026, we had $135.3 million of cash and short-term investments. This balance includes the February 2026 repayment at maturity of the remaining $17.1 million aggregate principal amount of our 2026 unsecured convertible notes (the "2026 Notes"). Following that repayment, our only remaining debt outstanding is $70.8 million aggregate principal amount of our 2029 Notes, which mature in June 2029. In April, the U.S. Centers for Medicare & Medicaid Services ("CMS") assigned a permanent Healthcare Common Procedure Coding System J-code specific for YARTEMLEA. This simplifies billing and reimbursement across payors. The J-code becomes effective on July 1, 2026. Also in April, CMS, in its Inpatient Prospective Payment System proposed rule, recommended approval of the New Technology Add-On Payment ("NTAP") for YARTEMLEA. NTAP provides additional payments to hospitals for certain high-cost, innovative technologies, helping bridge the gap until standard payment systems incorporate them. The final rule is expected in August, with NTAP expected to be effective October 1, 2026. "The launch of YARTEMLEA has changed the trajectory of Omeros, both operationally and financially," said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. "We are seeing strong early adoption across transplant centers, expand…Read full documentShow less
– Conference Call Today at 4:30 p.m. ET SEATTLE, May 13, 2026--(BUSINESS WIRE)--Omeros Corporation (Nasdaq: OMER) today announced recent highlights and developments as well as financial results for the first quarter ended March 31, 2026, which include: First Quarter and Recent Highlights In January 2026, we launched YARTEMLEA® in the U.S. market. During the quarter, gross product sales were $11.1 million and associated net sales, after deduction of wholesaler distribution fees and chargebacks, were $9.9 million. Net income for the first quarter of 2026 was $56.1 million, or $0.78 per share, compared to a net loss of $33.5 million, or $0.58 per share, for the first quarter of 2025. First quarter results include a $73.1 million non-cash gain associated with the mark-to-market adjustment on the embedded derivatives related to our 2029 unsecured convertible notes (the "2029 Notes"). Excluding the non-cash change in our embedded derivatives, non-GAAP adjusted net loss for the three months ended March 31, 2026 was $17.1 million, or $0.24 per share. At March 31, 2026, we had $135.3 million of cash and short-term investments. This balance includes the February 2026 repayment at maturity of the remaining $17.1 million aggregate principal amount of our 2026 unsecured convertible notes (the "2026 Notes"). Following that repayment, our only remaining debt outstanding is $70.8 million aggregate principal amount of our 2029 Notes, which mature in June 2029. In April, the U.S. Centers for Medicare & Medicaid Services ("CMS") assigned a permanent Healthcare Common Procedure Coding System J-code specific for YARTEMLEA. This simplifies billing and reimbursement across payors. The J-code becomes effective on July 1, 2026. Also in April, CMS, in its Inpatient Prospective Payment System proposed rule, recommended approval of the New Technology Add-On Payment ("NTAP") for YARTEMLEA. NTAP provides additional payments to hospitals for certain high-cost, innovative technologies, helping bridge the gap until standard payment systems incorporate them. The final rule is expected in August, with NTAP expected to be effective October 1, 2026. "The launch of YARTEMLEA has changed the trajectory of Omeros, both operationally and financially," said Gregory A. Demopulos, M.D., Omeros’ Chairman and Chief Executive Officer. "We are seeing strong early adoption across transplant centers, expanding formulary access, favorable reimbursement support, and growing physician experience with the first and only approved treatment for TA-TMA. At the same time, our Novo Nordisk transaction has strengthened our balance sheet and accelerated advancement of our pipeline, including next-generation MASP-2 programs, OncotoX-AML, OMS527 for cocaine use disorder under NIDA funding, and our T-CAT platform targeting multidrug-resistant pathogens. The progress achieved this quarter further demonstrates the strength of our science and the value we are creating across Omeros." Recent Developments YARTEMLEA and our other MASP-2 inhibitor programs A marketing authorization application ("MAA") for YARTEMLEA for the treatment of TA-TMA is currently under review by the European Medicines Agency ("EMA") with a decision expected in mid-2026. If approved, the MAA authorizes the product to be marketed in all EU member states and European Economic Area countries. We are assessing opportunities for YARTEMLEA across indications involving lectin pathway activation, including acute respiratory distress syndrome (ARDS), sickle cell disease, acute kidney injury, solid organ transplant-related TMA, and delayed graft function. In parallel, we are finalizing selection of an indication for a Phase 2 clinical program for OMS1029, our long-acting antibody targeting MASP-2. In our MASP-2 small-molecule inhibitor program, we have selected a drug development candidate and are advancing to IND-enabling studies. OMS527 for the treatment of addiction — cocaine use disorder program funded by the National Institute on Drug Abuse ("NIDA") We are developing, at NIDA’s request, our lead orally administered phosphodiesterase 7 ("PDE7") inhibitor for the treatment of cocaine use disorder. Preclinical studies, designed with NIDA toxicologists, were completed and showed no drug-interaction or safety issues, supporting the scheduled in-patient human study of OMS527 in cocaine users. Following FDA’s request for additional nonclinical information and a subsequent meeting with FDA to discuss that request, we are working with FDA to streamline the path to initiate the in-patient clinical trial, targeted for initiation by year-end 2026. Oncology platform — OncotoX-AML We continue to progress preclinical studies within our novel oncology program. The lead indication for development is acute myeloid leukemia ("AML"), an aggressive and highly fatal bone marrow and blood cancer. We have completed selection of a drug development candidate in the OncotoX-AML program, and IND-enabling studies are underway. OncotoX-AML shows broad application across AML regardless of genetic mutation, including TP53, NPM1, KMT2A, and FLT3, collectively found in approximately 90% of AML patients. In human tumor-bearing animal and in vitro human AML cell-line studies, our AML therapeutic candidate has demonstrated superior efficacy to current AML standard of care treatments. In February 2026, we announced the successful completion of our initial study in nonhuman primates evaluating the efficacy and safety of OncotoX-AML. Administration of only one course of OncotoX-AML treatment to immunocompetent primates demonstrated the desired pharmacologic response, selectively reducing myeloid progenitor cells, which can mutate and lead to AML, by up to 99%. OncotoX-AML was well tolerated. There were no observed safety signals or meaningful changes in blood chemistry values. Targeted Complement Activating Therapy ("T-CAT") platform Our T-CAT platform is a new class of recombinant antibodies designed to target and directly kill pathogens, including bacteria, fungi, viruses, and parasites. Our initial focus is on multidrug-resistant organisms ("MDROs"), one of the most critical unmet needs in medicine. Data from our T-CAT platform were recently featured in a podium presentation at the annual congress of the European Society of Clinical Microbiology and Infectious Diseases. The seminal manuscript describing our T-CAT technology was accepted for publication in Science Translational Medicine. Financial Results Commercial distribution and sales of YARTEMLEA commenced in January 2026. Gross product sales for the three months ended March 31, 2026 were $11.1 million, with net sales of $9.9 million. Revenue for the period reflects sales of YARTEMLEA to U.S. wholesalers. Net income for the first quarter of 2026 was $56.1 million, or $0.78 per share, compared to a net loss of $33.5 million, or $0.58 per share for the first quarter of 2025. The change in fair value of financial instruments as shown in our statement of operations and comprehensive income (loss) reflects marking to market the embedded derivative on our 2029 Notes under GAAP. Excluding the net gain on the change in the fair value of our financial instruments, which is non-cash, our non-GAAP adjusted net loss for the three months ended March 31, 2026 was $17.1 million, or $0.24 per share. At March 31, 2026, we had $135.3 million of cash and short-term investments. Upon their maturity in February 2026, we repaid the remaining $17.1 million outstanding principal balance of our 2026 Notes and currently have only $70.8 million aggregate principal amount outstanding of our 2029 Notes, which mature in June 2029. Total operating expenses for the three months ended March 31, 2026 were $27.3 million compared to $35.0 million for the three months ended March 31, 2025. The $7.7 million decrease was primarily due to reduced OMS906-related research and development work as a result of the zaltenibart asset sale and licensing agreement with Novo Nordisk in November 2025. Interest expense increased $2.2 million for the three months ended March 31, 2026 compared to the three months ended March 31, 2025. The increase primarily relates to interest incurred on the 2029 Notes and, to a lesser extent, a non-cash remeasurement charge taken on our OMIDRIA royalty obligation in the prior year, offset by decreased interest incurred on our 2026 Notes, which were repaid in February 2026. Interest and other income was $1.5 million for the three months ended March 31, 2026 compared to $1.1 million for the three months ended March 31, 2025 due to holding higher cash and investment balances in the current period. Net income from discontinued operations, net of tax, was $4.8 million, or $0.07 per share, for the three months ended March 31, 2026 compared to $4.1 million, or $0.07 per share, in the prior year period. During the three months ended March 31, 2026, we repurchased and retired approximately 0.4 million shares of common stock pursuant to our share repurchase program, at an average cost of $11.70 per share, for an aggregate purchase price of $4.2 million. 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, please register at the following URL https://events.q4inc.com/attendee/275761840 or go to Omeros’ website at https://investor.omeros.com/upcoming-events. A replay of the call will be made accessible online for 90 days at https://investor.omeros.com/archived-events. About Omeros Corporation Omeros is an innovative biotechnology company that discovers and develops first-in-class protein and small-molecule therapeutics for both large-market and orphan indications, with a focus on complement-mediated diseases, cancers, and addictive or compulsive disorders. Omeros’ lead complement inhibitor YARTEMLEA® (narsoplimab-wuug), which targets the lectin pathway’s effector enzyme MASP-2, is FDA-approved and commercially available in the U.S. for the treatment of hematopoietic stem cell transplant-associated thrombotic microangiopathy (TA-TMA) in adult and pediatric patients aged two years and older. A marketing authorization application seeking approval of YARTEMLEA for TA-TMA is currently under review at the European Medicines Agency. OMS1029, Omeros’ long-acting MASP-2 inhibitor, has successfully completed Phase 1 clinical trials. Under a recently announced asset purchase and licensing agreement, Novo Nordisk acquired global rights to zaltenibart (formerly OMS906), an inhibitor of MASP-3, the alternative pathway’s key activator, which is in clinical development for PNH and other alternative pathway indications, along with associated intellectual property and related assets. Omeros’ pipeline also includes OMS527, a phosphodiesterase 7 inhibitor in clinical development for cocaine use disorder, which is fully funded by the National Institute on Drug Abuse, and a growing portfolio of novel recombinant antibodies targeting multidrug-resistant organisms and novel molecular and cellular therapeutic programs for oncology. 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 therapeutic benefits of drug candidates within our development pipeline, expectations regarding our marketing authorization application for YARTEMLEA® in Europe, plans and expectations regarding the commercial launch of YARTEMLEA in the U.S., and in the EU following any EMA approval, our expectations regarding the effectiveness of the J-code and its utility, our ability to consummate licensing, partnering or other transactions and the benefits, if any, we would receive from any such transactions, expectations regarding the sufficiency and availability of our capital resources to fund current and planned operations, including the commercialization of YARTEMLEA 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 regulatory conclusions or interpretations related to the clinical data, external registry data, statistical analyses or other information and data included in our marketing authorization application or inability to respond satisfactorily to information requests during regulatory review of the thereof, unanticipated or unexpected outcomes or requirements of regulatory processes in relevant jurisdictions, our financial condition and results of operations, including our ability to raise additional capital for our operations or complete other transactions on favorable terms or at all, 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, 2026. 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. Non-GAAP Financial Measures This press release includes financial measures that are not calculated in accordance with U.S. generally accepted accounting principles (GAAP). A non-GAAP financial measure is generally defined as one that purports to measure historical or future financial position, results of operations or cash flows but excludes or includes amounts that would not be included in most GAAP measures. We define and use the non-GAAP financial measure of Adjusted Net Loss which represents net loss adjusted to remove the non-cash remeasurement on the fair value of financial instruments. We believe Adjusted Net Loss and Adjusted Net Loss from Continuing Operations to be a more accurate measure in gauging the Company’s performance because it excludes the fluctuation in the fair value of Omeros’ embedded derivatives. These are not meant to be considered in isolation or as a substitute for comparable GAAP measures and should be read in conjunction with Omeros’ financial statements prepared in accordance with GAAP. These non-GAAP measures differ from GAAP measures with the same captions, may be different from non-GAAP financial measures with the same or similar captions that are used by other companies, and do not reflect a comprehensive system of accounting. View source version on businesswire.com: https://www.businesswire.com/news/home/20260513494036/en/ Contacts Jennifer Cook Williams Cook Williams Communications, Inc. Investor and Media Relations [email protected]

