Gregory Demopulos - Chairman & CEO:

Good afternoon, and welcome to today's earnings call for Omeros Corporation. At this time, all participants are in a listen-only mode. After the company's remarks, we will conduct a question-and-answer session. 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 for one week from today. I'll turn the call over to Jennifer Williams, Investor Relations for Omeros.

Good afternoon, and thank you for joining the call today. I'd like to remind you that, some of the statements that will be made on the call today will be forward-looking. These statements are based on management's beliefs and expectations as of today only and are subject to change. All forward-looking statements involve risks and uncertainties that could cause the company's actual results to differ materially. Please refer to the special notes in the Risk Factors section regarding forward-looking statements in the company's quarterly report on Form 10-Q, which was filed today with the SEC, and the Risk Factors section of the company's most recent annual report on Form 10-K for a discussion of these risks and uncertainties. Now I would like to turn the call over to Dr. Gregory Demopulos, Chairman and CEO of Omeros.

Thank you, Jennifer, and good afternoon, everyone. I'm joined on today's call by David Borges, our Chief Accounting Officer; Nadia Dac, our Chief Commercial Officer; Andreas Grauer, our Chief Medical Officer; Cathy Melfi, our Chief Regulatory Officer; and Steve Whitaker, our Vice President of Clinical. Today, I'll start with an overview of our first quarter financial results and provide updates across our development programs. David will then go through our financials in more detail and we'll open the call for questions. Now let's look at our financial results for the first quarter. Our net loss was $33.5 million or $0.58 per share, compared to a net loss of $31.4 million or $0.54 per share in the fourth quarter of last year. As of March 31st, 2025, we had $52.5 million of cash and investments on hand. I'd like to start with how we are strengthening our balance sheet and addressing our liquidity position and the options available to us for raising capital. While we've been focused on achieving significant milestones across our development programs, which I'll discuss shortly, we've also been actively pursuing ways to strengthen our balance sheet and manage our debt maturities. Earlier this week, we announced an exchange agreement with certain holders of our 2026 convertible notes, exchanging about $71 million in principal for new 9.5% convertible senior notes due out in 2029. We also reached an agreement with two affiliated holders to convert $10 million of their 2026 notes into equity over a period of 90 to 120 with the entire amount to be converted by September of this year. As a result, the outstanding balance on the 2026 notes will be reduced to approximately $17 million, eliminating the need to make a $20 million mandatory prepayment of our existing term loan by November 1st, to…

Thanks, Greg. Our net loss for the first quarter of 2025 was $33,500,000 or $0.58 per share compared to a net loss of $31.4 million or $0.54 per share in the fourth quarter of last year. As of March 31st, 2025, we had $52.4 million of cash and investments on hand. As Greg just mentioned, earlier this week, we entered into an exchange agreement with certain holders of our 2026 convertible notes. We exchanged $70.8 million in aggregate principal amount of the 2026 convertible notes for newly issued 9.5% convertible senior notes due in June 2029 on a one-for-one basis. In addition, we reached an agreement with one holder to convert $10 million of the 2026 notes into shares of the company stock in three separate tranches over the next 90 to 120 days with the conversion to be finalized by September 2025. Following these transactions, the outstanding principal balance of the 2026 notes will be reduced to approximately $17.1 million. Most importantly, this reduction in principal of the 2026 convertible notes enables 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 01, 2025 to avoid an accelerated maturity of the term loan. As a result, our total outstanding debt will be reduced by $10 million and our potential debt repayments over the next 12 months would be lowered by over $100 million from $117.9 million to $17.1 million. These actions improve our financial flexibility, strengthen our balance sheet and position the company to better execute on its long-term plans. Constant expenses from continuing operations for the first quarter before interest and other income were $35 million, which was a decrease of $691,000 from the fourth quarter of last year. Research and development expenses…

Thanks, David. Operator, now let's please open the call for questions.

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

Thanks for taking the questions. I do have one, and since everything is pretty much being driven to the launch, can you give us as much detail as you can on not just launch plans, but how you are prepared for the launch itself and what does this mean, as far as patient access and anything else you want to add? Thanks and I'll hop back in the queue.

Yes. Thanks, Steve. Look, we're well prepared for the launch. Our commercial team has done a lot of work. And I think, we are expecting, again assuming approval, which we do, that the launch will be very successful. Let me turn that over though to Nadia for more detail.

Thanks, Greg. Yes, we have a small but mighty team that has been extremely focused, in this area. And the good news is that, the consolidated prescriber base, we know, where the transplant centers are. We understand the allogeneic volume by center. So our team has been focused on what we call top 40 centers that are responsible for driving just above 50% of allogeneic transplant volume. With time, we've actually gone a little deeper to the next 40% that gets us to about 80% of that volume. So, we've cultivated what we're calling Fast Start accounts. And we understand the decision making in these accounts. We know who the transplant champion is. And not only that, these are centers that are actively and proactively monitoring for TA-TMA signs and symptoms. So they understand this complication of allogeneic transplants. And then, we also know the transition from inpatient to outpatient, because with profile of narsoplimab, we believe, its efficacy plus safety profile lends itself to be infused both in inpatient as well as outpatient settings based on those experts' preference. And, we've also been engaging with payers. The exciting news is after we resubmitted our BLA, we've had several payers reach out for what we call product information exchanges. In fact, we've got one set up next week and several immediately after, and we expect that we'll have even more requests for those, as we approach our PDUFA day. This is important because, for economic plans, they've got to evaluate what's on the horizon and having a significant value driver, for a complication where nothing is currently approved is important to them. And they do view the fact that, narsoplimab being the only, potential product indicated for TA-TMA is a significant value driver. So the disease education continues, the identification of accounts, knowing all of the stakeholders, not just the transplant physician, puts us in a really successful position, plus, the data is just so compelling, with a significant value proposition for all of those stakeholders involved. So we are excited for that approval to come in.

Thank you, Nadia. Did that answer your question, Steve?

Yes. It did. But it also raised two more. I will throw them in the equation as well. On the first one, obviously, there's something that has to be, I guess, detailed more. These are extremely sick patients. So, as far as that goes, if you can provide any color on the patients we're talking about because, obviously this is a life-threatening situation for which there's just no other reasonable therapy that works. Can you talk more about those patients and how they got there? And the additional question along that, and I this time, I do promise to hop back in the queue. A great deal of money has been spent on these patients. They've had stem cell transplants, and these are not easy procedures, but they're also extremely laborious in terms of health care costs. Can you go into any detail about that? And the whole purpose there is to talk about this, the support of these patients buying narsoplimab and what it means. And I leave it to you as to how much detail you can give us on that. Thank you again.

Sure. Let me just make sure we understand the first question. It was, how did those patients get there? And I just want to make sure, we're answering that question. What specifically are you referencing when you say how did they get there?

These are hematological oncology patients, who've wound up through medical intervention that are there. So, can you detail some of that, because that's the part that people automatically assume on stem cell TA-TMA?

Yes, sure. Look, TA-TMA is a complication of stem cell transplant, but it's really wholly unpredictable. So patients, their families, their loved ones go through the transplant process, which as you can imagine is stressful, is costly as you've already identified. And there's obviously a tremendous amount of hope that, that stem cell transplant is going to extend the life of or cure the patient. And all of a sudden, out of left field without any warning comes TA-TMA. And this is not a disease that has a long and lingering span. This is a disease that comes hard, it can come fast and it can result in death not in months-and-months, but really days-to-weeks. And you can imagine the hit to the patient, to the family, to all of those concerned about that patient, when things are looking great and all of a sudden things turned really south really quickly. So the idea here is, that is what we're facing. There is no approved treatment. There are off-label treatments, which really have mixed results. There are reports of some efficacy. There are also reports of actually increased safety risks. And we are working hard and expect that narsoplimab will be the first drug approved for TA-TMA. With respect to your second question about the costs, let me turn that over to Nadia and then I'll see if anyone wants to additionally comment on what I've just relayed in response to your first question.

Yes. Steve, you are spot on in terms of the cost associated with untreated patient. Whether it's ICU or inpatient, those are the significant cost drivers. And so, in terms of the economic value that we're looking at and how we're building that story for narsoplimab, when you have a treatment that's the only one indicated for TA-TMA with the kind of survival benefit that we've demonstrated in our data, when you compare that versus the cost of a patient developing end organ damage, kidneys failing, dialysis, transplant potentially of organs or death, there is no comparison. And preserving that patient and reducing the cost, of course. And so, that is how we're looking at this, and this is also how other stakeholders are taking that to consideration. The other aspect of that, that I will highlight is, the ability of a drug to be used outpatient is also a significant value driver because it is less expensive to dose the patient outpatient. So with this kind of efficacy, the goal is to get the patient as quickly as possible from ICU to inpatient, from inpatient to outpatient, and that's the goal, with why I say the entire profile is efficacy plus safety, because we know in this space, in the transplant space, there's some treatments that are exclusively inpatient dosed. And that's quite limiting, where we don't see the same concerns with narsoplimab potentially.

Got it. Thanks for the color and the detail. Let me hop back in the queue.

[Operator Instructions]

All right. Operator, it appears no other questions. With that, I'd like to thank everyone for joining us today. We appreciate the continued support and confidence of our investors and lenders. We remain focused on executing with discipline and securing the capital resources necessary to bring us through to the anticipated approval of narsoplimab, a successful commercial launch and the development of our pipeline. We expect all of those things to occur and we look forward to providing updates over the near-term. All of us at Omeros appreciate your continued support. Have a good evening, and we look forward to speaking with you again.

This concludes today's conference call. Thank you for participating. You may now disconnect.