OMER - NASDAQ

Good afternoon, and welcome to today's earnings call for Omeros Corporation. [Operator Instructions] Please be advised this call is being recorded at the company's request, and a replay will be available on the company's website 1 week from today. I will now turn the call over to Jennifer Williams, Investor Relations for Omeros.

Good afternoon, and thank you for joining us. Before we begin, I'd like to remind you that certain statements made during this call are forward-looking. These statements reflect management's current beliefs and expectations as of today and are subject to change. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially. For a discussion of these risks and uncertainties, please refer to the special note and the Risk Factors section regarding forward-looking statements in our quarterly report on Form 10-Q filed today with the SEC and the Risk Factors section of our most recent annual report on Form 10-K. With that, I'll turn the call over to Chairman and CEO of Omeros, Dr. Greg 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 [Audio Gap].

Ladies and gentlemen, we thank you for your patience. We do apologize this is a notified conferencing problem. I'd like to turn the call over to Jennifer Williams for the safe harbor. Please go ahead, ma'am.

Good afternoon, and thank you for joining us or sticking with us. Before we begin, I'd like to remind you that certain statements made during this call are forward-looking. These statements reflect management's current beliefs and expectations as of today and are subject to change. Forward-looking statements involve risks and uncertainties that could cause actual results to differ materially. For a discussion of these risks and uncertainties, please refer to the special note and the Risk Factors section regarding forward-looking statements in our quarterly report on Form 10-Q filed today with the SEC and the Risk Factors section of our most recent annual report on Form 10-K. With that, I'll turn the call over to Chairman and CEO of Omeros, Dr. Greg 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. I'll begin with an overview of our second quarter 2025 financial results and provide updates across our development programs. David will then walk through the financials in more detail, and we'll open the call for questions. Our net loss for the second quarter of 2025 was $25.4 million or $0.43 per share compared to a net loss of $33.5 million or $0.58 per share in the first quarter of this year. As of June 30, 2025, we had $28.7 million in cash and investments. This was further strengthened by a registered direct offering completed on July 28, 2025, which raised $20.6 million in net proceeds. During the quarter, we took decisive steps to strengthen our balance sheet and extend our debt maturity profile. Through a combination of convertible note exchanges and equity conversions, we reduced the outstanding principal on our 2026 notes from $98 million to $17 million, eliminated a $20 million mandatory prepayment on our term loan and extended the large majority of our debt out to 2029. These actions, including the July offering with Polar Asset Management Partners reduced our near-term payment obligations by over $100 million. This further positions us to focus capital on advancing key programs and supporting the anticipated launch of narsoplimab. We've removed a major structural overhang, streamlined our balance sheet and are now better positioned to access additional capital through partnerships equity or debt offerings or sales under our active ATM Facility. As previously disclosed, we're in discussions regarding potential asset acquisition and/or licensing agreements involving certain of our clinical assets. The most advanced of these discussions is driving toward a multibillion-dollar transaction, exclusive of royalties. Upon closing, we expect to receive an upfront cash payment sufficient to repay in full the $67.1 million term loan outstanding under our senior secured credit facility. Repay at maturity the remaining $17.1 million principal balance of our 2026 convertible notes and provide sufficient capital for over 12 months of post-closing operations. This transaction is also expected to include near- and longer-term milestones and if regulatory approval is obtained, sales-based milestones and royalties. Let's now turn to the anticipated approval and launch of narsoplimab, our proprietary human monoclonal antibody against MASP-2, the key activator of the lectin pathway of complement. While we've identified several commercially attractive follow-on indications for narsoplimab, the initial indication is stem cell transplant-associated thrombotic microangiopathy or TA-TMA, a life-threatening complication of stem cell transplant. In March, we resubmitted our Biologics License Application, or BLA, for narsoplimab in TA-TMA. The FDA accepted the submission for review and assigned a PDUFA target action date of September 25. Following our submission of additional information requested by FDA, the agency extended the PDUFA date to December 26. We continue to work collaboratively with FDA. Our objective is to expedite the review and potential approval process. To date, results of all requested analyses have been shown to be statistically significant and are consistent with and supportive of narsoplimab benefits as demonstrated in our BLA resubmission. Assuming no major deficiencies are identified during its review, FDA has indicated that labeling discussions are planned to begin no later than October 2025. In June, we submitted our marketing authorization application or MAA for narsoplimab in TA-TMA to the European Medicines Agency. The MAA has been validated, initiating formal review process by the Committee for Medicinal Products for Human Use. We expect a decision on the MAA in mid-2026. We continue to expect that narsoplimab will be the first approved therapy for TA-TMA and that it is well positioned to address a substantial market opportunity. Awareness is growing among transplant physicians regarding the risks of C5 inhibitors like eculizumab and ravulizumab, which are often used off-label in TA-TMA and have been shown to be associated with increased infection rates and related complications. A retrospective single-center case control study published last month in the American Journal of Hematology found that pediatric TA-TMA patients treated with the C5 inhibitor eculizumab had significantly higher infection rates compared to well-matched controls. Specifically, in the eculizumab-treated group, bacteremia was 8.5-fold higher and 1-year infection-related mortality was sixfold higher. Similar findings are being reported in adults. Mechanistically, C5 inhibitors like C3 inhibitors block the infection fighting lytic arm of the classical pathway of complement. Markedly increasing risk of infection and death in immunocompromised patients. In contrast, by targeting and inhibiting MASP-2, narsoplimab preserves the classical pathways lytic function and the adaptive immune response. We believe both safety and efficacy will be key differentiators and drivers of adoption for narsoplimab. Two manuscripts will soon be published in premier peer-reviewed journals detailing narsoplimab's safety and survival benefits in high-risk TA-TMA patients. The first already accepted for publication, assesses survival in both adults and children treated under expanded access. The second is under review and compares narsoplimab-treated adults in both the pivotal trial and in the expanded access program to a well-matched external control. Thanks to the continued efforts of our field-based market development and access teams, we're well positioned to drive demand in our highest priority transplant centers upon approval. These centers are already actively monitoring for signs and symptoms of TA-TMA and are familiar with narsoplimab and its clinical profile. We're executing a phased onboarding of hematology-experienced sales professionals who first will target the highest volume transplant centers, expanding more broadly over time. Our sales leadership is currently in active discussions with top-tier candidates with deep expertise in transplant and rare hematologic diseases. Notably, many have been closely following narsoplimab's development and are genuinely enthusiastic to launch a product that can significantly improve outcomes and save patients' lives. In parallel, we're engaging hospital decision-makers and payers through pre-approval information exchanges to support planning for coverage and reimbursement. Feedback has been highly encouraging. Stakeholders recognize the strong clinical safety and efficacy data for narsoplimab and are eager for an approved treatment option that avoids the risks associated with off-label C5 inhibitors. Upon approval, we will leverage our experienced field marketing team and a highly skilled sales force to drive rapid uptake. By emphasizing the compelling clinical data and proactively addressing access barriers, we're confident in our ability to deliver a successful launch and life-saving outcomes to TA-TMA patients and their families. Looking to the rest of our MASP-2 inhibitor family, OMS1029, our long-acting once-quarterly MASP-2 antibody is ready to restart Phase II clinical trial activities once resources are available. We have adequate supply of OMS1029 and matched placebo to support the Phase II program. Our orally administered small molecule MASP-2 inhibitor program is nearly ready to begin IND-enabling studies. Both programs target indications suited to their respective delivery modes and pharmacologic profiles. Turning to our MASP-3 inhibitor program.

Thanks, Greg. Our net loss for this second quarter of 2025 was $25.4 million or $0.43 per share compared to a net loss of $33.5 million or $0.58 per share in the first quarter of this year. As of June 30, 2025, we had $28.7 million of cash and investments on hand. And as Greg mentioned, we closed a registered direct offering on July 28, in which we received net proceeds of $20.6 million. As we noted in our May 13 conference call, we entered into an exchange agreement with certain holders of our 2026 convertible notes. We exchanged $70.8 million in aggregate principal amounts of our 2026 convertible notes on a one-for-one basis for newly issued convertible senior notes due in June 2029. In addition, we reached an agreement with 2 holders to convert $10 million of their 2026 notes into shares of the company's stock in 3 tranches over a 90-day period with the conversion to be finalized by mid-September 2025. Following these transactions, the outstanding principle balance of our 2026 notes has been reduced from $97.9 million to $17.1 million. Most importantly, this reduction in principle of the notes enabled the company to avoid making a $20 million mandatory prepayment under our term loan agreement, which otherwise would have been required on or before November 1, 2025. These transactions significantly pushed out debt maturities with only $17.1 million of debt due within the next 12 months. And recall that we entered into a capped call transaction in connection with the issuance of the 2026 notes to reduce potential dilution or cash outlay upon conversion. Even with the outstanding balance of the '26 notes down to $17.1 million, we have retained the full potential value of the capped call, up to $92.6 million. Costs and expenses from continuing operations for the second quarter before interest, another income were $32.4 million, which was a decrease of $2.6 million from the first quarter of this year. Research and development expenses in the second quarter were primarily focused on

Thank you, David. Operator, let's now please open the call to questions.

[Operator Instructions] Our first question comes from Steve Brozak with WBB Securities.

I really want to go over the financial modeling of narsoplimab. And I'd like to compare it, if you don't mind. You've launched a product in the past. Obviously, it's been a while, OMIDRIA. And you've got about $1 billion plus in revenue on that product more at the end of the day. how does that launch compare to what you're preparing for? You can go in as much detail as you like, and I have one follow-up after that.

Okay. Thanks, Steve. We have not delivered a lot of information publicly about our planned launch projections around the launch. What I can tell you is that it is a significantly more focused market than what we had with OMIDRIA. With OMIDRIA, we were targeting cataract surgeons of which there are a good number, a large number nationally. With TA-TMA as the indication, transplants are done in 175 centers across the nation. So the number of on-the-ground salespeople is significantly less than what we needed for OMIDRIA. So that is clearly an advantage. We see the market opportunity, obviously, as large. I think others do as well, which is why there have been others in development for TA-TMA. But I think with respect to specific numbers, pricing, launch projections, any of that information, we're going to beg off for that right now, Steve. It's just not the appropriate time, I think, to go through that. But know that we clearly are working through how to optimize the launch and make sure that with narsoplimab, once approved, that we are able to reach as many physicians and patients, both in the U.S. and ex U.S. that we can. We're very confident in the...

Got it. Okay. That leads me to patient -- are very, very sick. Can you hear me now?

I can now...

Okay. Let me dive right in. The patient population you're talking about right now is very, very sick. And they've also had extraordinary expenses, a paid for their treatment process up until the TA-TMA hit. How comfortable are the clinicians that you've talked to or that you've worked with so far and saying, yes, they want this product, and it is clearly something that is needed on an urgent basis, and I'll hop back in the queue.

One, my take on that is that the physicians are eagerly awaiting the approval of narsoplimab. But let me hand that over to Nadia, who I think can give you more detailed information on the response from physicians. Nadia?

Yes. Thanks, Greg. Steve, it's really a significant response from physicians about the need for narsoplimab. You can imagine, you just commented on it that these patients have been through so much just to go on this journey with transplant and to be sort of nearing or getting out of the woods and then having a lethal complication is absolutely not what the physicians or the patients would want. And so they see this as a much needed solution. The fact that it is -- it would be indicated, the first two only. And in terms of those that have had response already through the expanded access program, they're eager to have this approved and be able to assist these patients and to avoid these kinds of complications.

Does that answer the question, Steve? I think if there's any bright side to the length of time we've been waiting to get narsoplimab approved in TA-TMA, it's been the ability for physicians through the expanded access program and obviously, through numerous presentations, publications to understand the effects of narsoplimab, the benefits of narsoplimab and frankly, some of the challenges or risks associated with potential competitors in development.

Our next question comes from Brandon Folkes with H.C. Wainwright.

Congrats on the targets. if you are approved in December, how long would you anticipate before you could launch the product? And then maybe just sort of along the same lines, I think going into the prior PDUFA I'm talking a couple of years ago, I know you built a fair amount of inventory. So I'm just thinking if we should be thinking about the same sort of approach this way around and modeling that into our R&D spend in 4Q.

Good question, Brandon. Thank you. You were breaking up a bit, but I think I caught it. We again are hopeful that we will reach an approval decision before December. But using your assumptions that approval were to occur in December, we would, as you understand, not be launching in December, but we would be launching then in the first quarter. And I think, obviously, we are geared up and ready to go. With respect to supply, we have substantial supply, and that is not going to be a challenge in any way for us. Nadia, do you have any comments on the launch or David on supply?

I'll build on the launch before David comments on the supply. What we have in place is a plan to, upon approval, immediately train our field team that's in place on the narsoplimab package insert information, and they will be deployed immediately upon certification, followed by the sales reps then that would be onboarded. So we will be driving awareness, education and demand immediately upon approval. And then we have some other things lined up that would be nonpersonal in terms of digital tools and other things to supplement that because we view this as really it's two-pronged. We have to continue the education on TA-TMA while then educating on narsoplimab while the supply prepares to fill the channel as well. David, let me hand it back to you.

Yes. With respect to supply, we have adequate supply for the first several years from launch. So I think we're in great shape there with respect to our inventory. Brandon?

Thank you Greg and everyone. That answers my question. Congrats on the progress.

Our next question comes from Olivia Brayer with Cantor.

Greg, can you talk about what the FDA requested that actually led to the 3-month PDUFA delay? Was it additional data from the historical database or something else? And then anything in that request that was maybe unexpected? And then I've got one follow-up.

Olivia, thanks for the question. It was really additional analyses. There were a number of analyses that they were requesting. And frankly, I think it may have been a bit overwhelming the amount of data that we subsequently supplied in response. And so that is my view of that. Cathy, do you want to elaborate?

Yes. Again, as Greg said, they requested additional analyses, apparently felt that they could not review it in time to make the original PDUFA date. And as you know, when you get a major amendment, the standard is to act 3 months on to the PDUFA date. We're continuing to work with FDA, and we're hoping, as Greg said before, we can bring it in even earlier than the December 26 date.

The relationship, Olivia, has been really quite collaborative. I know that there are a number of issues that are at least finding their way into the press around FDA and recent responsiveness. Frankly, we have not encountered any of that with this division. The interactions have been responsive and very collaborative. So to date, that's how we have found this process.

Yes. That's great. I'm happy to hear that, and hopefully, that continues going forward. And then can you tell us anything more about the potential partnership that you're pursuing? And just maybe what kind of partnership and which program in particular that you're looking to partner out?

Yes. All I can say on that at this point is that there's substantial interest really across our programs. And we've outlined the parameters of one such partnership. And as you might imagine, we're required to do so as part of our equity financing to make sure that all material nonpublic information was cleansed. So I think we've said really all that we can say or really will say on that topic at this point. But I think our referencing it by definition means that it is material from our position.

And I'm not showing any further questions at this time. I'd like to turn the call back over to Dr. Demopulos for any further remarks.

All right. Thank you, operator. Thank you, everyone, for joining this afternoon. We apologize for that initial difficulty with the technical component. I appreciate the help though that our provider did put forth to fix the problem quickly. So thank you. But as you can see, Omeros has a good number of value-driving milestones in process, and we look forward to sharing more information with you throughout the remainder of 2025. All of us at Omeros appreciate your continued support and look forward to sharing further updates with you. Have a good evening.