Omeros Corporation Q4 2025 Earnings Call - YARTEMLEA approved and commercial, $240M Novo deal strengthens balance sheet

Operator: 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 hand the conference over to Jennifer Williams, investor relations for Omeros. Please go ahead.

Jennifer Williams, Investor Relations, Omeros Corporation: 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 sections in our annual report on Form 10-K, which was filed with the SEC today. Today’s call will include a discussion of certain non-GAAP financial measures. A reconciliation of these non-GAAP measures to the corresponding GAAP measures is included with Omeros’ earnings press release issued earlier today, which is available on the Investor Relations page of our website and has been furnished with the Form 8-K we filed with the SEC earlier today. With that, I’ll turn the call over to Dr.

Greg Demopulos, Chairman and CEO of Omeros.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: 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. Kathy Melfi, Chief Regulatory Officer, and Dr. Steve Whittaker, 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. 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 three, 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 one-time development and approval milestone payments and up to $1.3 billion in one-time 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 2025 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, and TA-TMA, an 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 boxed 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 three weeks of January, first sales occurred shortly thereafter.

Within 24 hours of placing an order, both adult and pediatric TATMA 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 8-10 vials per treatment course. We expect the majority of a TATMA patient’s 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 TATMA 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, analyses using the uniformly strong clinical efficacy data and favorable safety profile of YARTEMLEA to demonstrate its compelling cost-effectiveness to healthcare 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 mid-year. 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 non-cash 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 OMS 527 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 TCAT platform has also made substantial strides. Our TCAT 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, TCAT 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, TCAT 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 TCAT 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 non-human 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, Chief Accounting Officer, Omeros Corporation: Thanks, Craig. 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 non-cash 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 non-cash remeasurement adjustments, 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 OMIDRIA 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 non-cash 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 cost. 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, the 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 2025, primarily reflecting higher average cash balances. In connection with the repayment of the term loan in November 2025, we recognized a $17 million non-cash gain related to the derecognition of the remaining unamortized premium. This was a one-time accounting adjustment associated with the repayment of the loan. During the fourth quarter, we reported a $135 million non-cash loss from 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, 2025 to $17.18 per share at December 31, 2025.

This embedded derivative reflects certain features of the notes, including the conversion option and interest make whole provisions available to note holders. Because evaluation 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 non-cash 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 non-cash 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 non-cash 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 2026 will be comparable to the fourth quarter of 2025. 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 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 non-cash adjustments related to the Omidria royalty obligation. Income from discontinued operations is expected to be in the $5 million-$6 million range, again, excluding any non-cash remeasurement adjustments related to the Omidria contract royalty asset. 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 non-cash and unpredictable, we present non-GAAP adjusted net income and loss measures, and they do not affect our operating guidance. With that, turn it back over to Greg.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: Thanks, David. Operator, please would you 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 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 Folks with H.C. Wainwright. Your line is open. Please go ahead.

Brandon Folks, Analyst, H.C. Wainwright: Hi. Thanks for taking my questions, and congrats on all the progress. Maybe just two from me. Yeah, 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, you know, I know it’s very early on in the YARTEMLEA launch, so kind of, you know, asking this with that asterisk, but, you know, any color on the real-world vial usage to date? You know, sort of any early data suggesting a different number of vials in the real world versus what we saw in the clinical data? Thank you.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: Hi, 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 think we expect that we will continue to see additional P&T approvals over the next several months. Our objective, of course, is to have P&T committee approvals across all of the top 80 and, frankly, beyond the top 80 sites. I’ll check with Nadia. Nadia, do you have any additional thoughts on that?

Nadia Dac, Chief Commercial Officer, Omeros Corporation: Yeah, completely agree with everything you said, Greg. 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. 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. We are seeing the use of YARTEMLEA in the hospitals, even without a P&T approval in place.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: 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. 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. I assume you’re asking whether it’s once weekly, twice weekly, but let me just make sure I understand the question.

Brandon Folks, Analyst, H.C. Wainwright: Yes. Ideally. Just, you know, anything you’re learning early on in the launch which may be different to what we saw in the clinical data.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: 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 information is being really well received by the transplant teams across the centers nationally. 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, Chief Commercial Officer, Omeros Corporation: Yeah, absolutely. 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. 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. The other thing that’s very encouraging is the published policies that we’ve seen to date with third-party payers. They’re supporting, you know, prior authorization to label. It’s not restricting the use of twice weekly dosing as needed.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: That help, Brandon?

Brandon Folks, Analyst, H.C. Wainwright: Very helpful. Thanks very much, and congrats on all the early launch progress.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: Thank you.

Operator: Your next question comes from the line of Olivia Brayer with Cantor. Your line is open, please go ahead.

Sam, Analyst, Cantor: Hey guys, 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 just had to pay the $29 million notes? And then under your formulary allowance, 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?

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: Sure. Hi, 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. I’m hoping that helped and cleared up any misunderstanding.

Sam, Analyst, Cantor: Yeah. That’s awesome. On your YARTEMLEA-

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: Sure.

Sam, Analyst, Cantor: What kind of bumps in the road have you encountered and what can you do to like smooth those out?

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: Yes. Again, we’ll get into this more in our Q1 call, which will be in about six weeks. 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. As I said, we’ve been in already sites that represent about 90% of the allogeneic transplants done nationally every year. The response has been from those centers really uniformly positive. I think that there’s an education process that’s going on. 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.

Again, I’ll turn it to Nadia and see if she has more information on that.

Nadia Dac, Chief Commercial Officer, Omeros Corporation: Yeah. The receptivity has been extremely positive. Our value proposition is viewed as significant and addressing an unmet need. I will say that all of the effort we put into the pre-launch period of educating on TATMA, the signs, the symptoms to identify it and the urgency to treat, we’re seeing the payoff of that education. Now with the first and only approved product for TATMA, that sense of urgency is playing out. If I were to pick on anything that we wanna smooth out, you know, 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 non-personal efforts. Because as we see, the patient can come from anywhere.

There are, you know, 175 centers. We wanna make sure that we’re supporting any of the HCPs out there that are looking for treatment and wanting to learn more about YARTEMLEA.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: I would agree with what Nadia said, that really we’re focused on educating. 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. When you look at the safety profile, that’s quite a favorable benefit risk profile that I think YARTEMLEA represents.

Sam, Analyst, Cantor: Thank you so much. If I can squeeze one last one in?

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: Sure, Sam.

Sam, Analyst, Cantor: Regarding the EMA decision by midyear and like partnership discussions, do you expect any impact from MFN and like ex-U.S. pricing?

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: Yeah. 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. 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 meetings. The interest in YARTEMLEA there was very high. Our focus is getting it approved, making it available for European patients, as we’ve already made it available through our expanded access program.

Sam, Analyst, Cantor: Okay. Amazing progress, guys, and thanks again for the questions.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: Oh, thank you, Sam.

Operator: Your next question comes from the line of Steve Brozak with WBB. Your line is open. Please go ahead.

Steve Brozak, Analyst, WBB Securities: Hey, thanks for taking the questions. I’d like to go back to something you raised in 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/onc are very, very familiar with your YARTEMLEA. But can you go into as much detail as possible as to the value proposition? ’Cause 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? ’Cause I’d like to put into perspective the criticality of what has just been done and what you’re now doing. I’ve got a follow-up after that, please.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: Hi, 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. 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. We think that there is obviously a strong case to be made, and we are making it, and we’ll be publishing that. Did that answer your question, or was it something additional?

Steve Brozak, Analyst, WBB Securities: No, no, it’s answered the question. Frankly, I was looking more for dollars and cents as to, you know, 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? Also, I know there’s 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.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: 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? 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. 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 C5 and to a much lesser extent C3 inhibitors have been used. You know, the costs associated with 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, C5 inhibition. What we have seen and what has been published is the markedly increased infection rate associated with C5 inhibition. I mean, up to a six-fold increase in infection-related mortality as reported in this set of publications. That carries, I think, a significant cost beyond the cost of the agents themselves. We think that where we are priced, the economic value proposition for narsoplimab or YARTEMLEA is really quite clear. 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?

Steve Brozak, Analyst, WBB Securities: Absolutely. Okay, a follow-up. You’ve been very transparent in saying that the hem-oncs, the hematological oncologists have been accepting of YARTEMLEA. Question I’ve got for you is, since it is obviously a critical mishap, how fast are you in being able to respond? ’Cause 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 those first few days are critical in understanding it? How? What feedback can you give us there? I’ll hop back in the queue. Thank you.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: Sure. Well, as we have set up our distribution channels, we can deliver drug, we are delivering drug within 24 hours of the request. 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 temporally, right? To be able to treat patients earlier, jump on it quickly, jump on it hard, meaning appropriately dosing. 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. 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, Chief Commercial Officer, Omeros Corporation: Yeah, absolutely. 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’ll 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. 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.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: 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. We’re quite pleased with. You know, we’re quite early in this launch. Our launch was really January, and here we are at the end of March talking of pharmacy and therapeutic committee approvals. To the extent that we have them, 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.

We’re really quite pleased by that and look forward to sharing additional information at our Q1 call.

Steve Brozak, Analyst, WBB Securities: Great. Well, thank you again for taking the question, and congrats on obviously the developments of 2025 and what you’ve just told us about Q1. Thank you again.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: Thank you.

Operator: Your next question comes from the line of Serge Bellinger with Needham. Your line is open. Please go ahead.

Serge Bellinger, Analyst, Needham: Hi, good afternoon. Thanks for taking my questions. 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. Then since we’re at the last day of the quarter, Q1 here, is it too early to talk about how many patient starts we’ve seen so far that have started treatment on the product? Thanks.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: The second question, I broke up a little bit, was how the response has been to the drug?

Serge Bellinger, Analyst, Needham: No, the second question was, since we’re on the last day of the first quarter, whether it was too early to get an idea of how many patient starts you have seen so far on the product.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: Okay. 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. 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, Chief Commercial Officer, Omeros Corporation: Yeah. The question is about the PA approval and whether those were handled by medical exception or by policy. The answer is both. 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. 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.

We have, you know, 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. We are very encouraged and really strong success to date.

Serge Bellinger, Analyst, Needham: Great. 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? Can you give us color on what triggers it?

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: Yes. We are by agreement with Novo Nordisk not able to specify what that collection of milestones ties to. I will tell you that we’re confident around the receipt of those. Again, can never guarantee these things, but I think our level of confidence is high.

Serge Bellinger, Analyst, Needham: All right. Thank you.

Operator: There are no further questions at this time. I will now turn the call back to Dr. Demopulos for closing remarks.

Dr. Greg Demopulos, Chairman and Chief Executive Officer, Omeros Corporation: 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 six 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.