OMER - NASDAQ

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 avoid triggering an accelerated maturity of the term loan balance. Overall, this will reduce our total debt by $10 million and lower our near-term repayment obligations by over $100 million, reducing it from approximately $118 million to $17 million. The debt extension moves maturity out to 2029 and removes a major overhang for all routes of securing near term capital. We also have an active at the market facility in place with the capacity to raise up to $150 million in aggregate, providing meaningful flexibility to access additional capital, when needed. With the debt exchange now having been completed, we're in the process of securing additional capital to support our operations through the anticipated approval and launch of narsoplimab, including active discussions around partnerships, which would bring non-dilutive funding. As we assess capital raising alternatives, we're also keeping a close eye on costs across the organization. We've taken meaningful steps to lower expenses while continuing to advance key initiatives and position the company for long-term growth. We've made good progress, but we know, it's critical to remain disciplined. We are carefully managing our cash and liquidity, to ensure we have the flexibility to deliver on our priorities and are committed to using our resources wisely, focusing investment on the areas that matter most to our shareholders and for near-term success of the company. This means that, certain activities and programs have been suspended or paused in order to prioritize the allocation of our currently available capital to the development of commercial infrastructure and capacities needed to ensure the successful launch of narsoplimab for the treatment of hematopoietic stem-cell transplant associated thrombotic micro-angiopathy or TA-TMA following the anticipated approval by FDA of our re-submitted biologics license application, and to the completion of our ongoing zaltenibart clinical trials with enrolled patients. As recently announced, FDA has accepted our resubmitted BLA for narsoplimab and TA-TMA and has assigned a target date for FDA action of September 25th. We have received and are responding to information requests as part of the process. Our primary analysis results show a hazard ratio of 0.32 with a p-value of less than 0.00001, meaning that narsoplimab resulted in a statistically significant threefold greater improvement in survival compared to the well-matched control group. All sensitivity analyses, including the analyses directed to our Expand a Access Program or EAP are strikingly consistent and strong and we look forward to working closely with FDA to bring narsoplimab to market as the first approved treatment for TA-TMA. Additionally, the ICD-10 codes established through our collaborative efforts with transplant experts and professional societies will create reimbursement hurdles for off-label treatments since narsoplimab will be the only approved treatment for TA-TMA. We're also moving forward to complete and submit a marketing authorization application or MAA to the European Medicines Authority for narsoplimab in TA-TMA. We're targeting to complete that submission later this quarter. Although pre-launch commercialization activities within our narsoplimab program will continue, we are suspending our expanded access program for narsoplimab, also known as compassionate use. Physician requests for access to narsoplimab under this program continue, and we are mindful that, the TA-TMA patients who lack an approved treatment for this often fatal condition will be most affected by cessation of access to narsoplimab prior to approval. Nevertheless, suspension of the program is necessary to eliminate direct costs associated with supplying the drug and the external management of the EAP. We remain committed to support patients, who are currently being treated under the EAP. This discontinuation of the program will not affect these currently treated patients. Additionally, our ongoing study of narsoplimab in pediatric patients with TA-TMA will continue. A manuscript detailing the data related to the primary analysis authored by an international group of leaders in the transplant field has been submitted for publication in a top tier journal. A second manuscript directed to the EAP results, again authored by international transplant leaders, is planned for submission early next week. A manuscript from Weill Cornell describing the role of MASP-2 in the lectin pathway in long COVID is also under review in a major peer reviewed journal. We expect that narsoplimab will be the first approved therapy in TA-TMA and nearly $1 billion annual market opportunity. Narsoplimab is positioned to become a cornerstone asset for transplant experts with label expansion opportunity in other transplant complications and to other disease fields. Our focus remains bringing narsoplimab to market as quickly as possible. Transplanners and their patients globally are waiting for it. Our other prioritized program is the development of zaltenibart, our lead antibody targeting MASP-3, the most proximal and key inhibitor of the alternative pathway of complement. The initial indication for zaltenibart is paroxysmal nocturnal hemoglobinuria or PNH. The global market for PNH including multiple treatment modalities is estimated to grow about 11% annually to over $10 billion in 2032. There remains significant unmet need for PNH patients and the complement inhibitor market specifically is expected to more than double from about $2.2 billion today to $4.7 billion in that same timeframe. We expect zaltenibart to carve out a significant share of that growing market. Our ongoing clinical trial evaluating zaltenibart for the treatment of PNH and treatment naive patients will continue. Also continuing is the extension study, which enrolls PNH patients treated with zaltenibart, who have completed any of our prior zaltenibart studies in this indication. Our Phase II study in C3G will also remain ongoing. Our Phase III zaltenibart program in PNH began initiating clinical trial sites last quarter. And based on capital considerations, the anticipated ramp-up in spending as well on those trials, we are pausing our Phase III PNH program temporarily and are working with our vendors and investigators to ensure that, the program is ready to restart with as little disruption to the time line as possible after securing capital. Market research confirms that zaltenibart's target profile is differentiated from the evolving PNH landscape. Reference drivers for zaltenibart include a compelling efficacy and safety profile with low treatment burden, 4x to 6x per year dosing, which minimizes how often patients have to think about their disease and infrequent IV administration, which minimizes both the risk of non-compliance and subsequent breakthrough disease, while aligning with the existing economic and treatment model of physicians' practices in PNH. Development spending on our long-acting, next generation MASP-2 inhibitor, OMS1029, remains limited. That asset is Phase II ready with drug product needed to support Phase II trials having already been manufactured and stored, pending the selection of the first indication and the resources to initiate Phase II studies. We've also reduced spending in our other areas of complement franchise, including our small molecule MASP-2 and MASP-3 programs as part of our effort to focus resources on core development priorities. Apart from our complement programs, our PDE7 inhibitor program evaluating OMS527 for cocaine use disorder or CUD will continue moving forward, funded entirely by a grant from the National Institute on Drug Abuse, or NIDA. Work on an upcoming inpatient clinical trial evaluating safety and preliminary efficacy of OMS527 in patients with CUD is ongoing with readout of those clinical data expected late this year or early next. In addition, we continue on a limited basis preclinical studies in our novel oncology platform, including IND-enabling studies in our OncotoX program. OncotoX is designed to target and kill only dividing cancer cells, treatment of acute myeloid leukemia or AML is the lead indication. Our OncotoX AML therapeutic has consistently demonstrated superior efficacy to current AML standard-of-care treatments, both in-vitro and in-vivo with human cell lines. OncotoX AML shows broad application across AML regardless of genetic mutations, including TP53 NPM1TP53, NPM1, KMT2a, and FLT3. This broad application certainly appears to be unique. Well tolerated and preliminary tolerability studies, IND-enabling work is ongoing and we expect to be in the clinic in 18 to 24 months. This work as well as clinical trials will be aided and guided by our distinguished clinical steering committee, all of whom lead AML treatment and research at their respective premier cancer centers. Based on positive feedback from stealth unveiling of our OncotoX data last month at the American Association of Cancer Research with prospective partners, we believe that, this program has potential to drive substantial value at an early stage of development, meaning in the near-term. I'll now turn the call over to David, our Chief Accounting Officer, to go through a more detailed discussion of our financial results. David?

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 in the first quarter were heavily focused on narsoplimab and zaltenibart. Interest expense for the first quarter was $3.7 million, which reflects a $477,000 increase as compared to the fourth quarter of last year. The primary components of interest expense are the 2026 notes, the DRI, OMIDRIA royalty obligation and the secured term loan. In the first quarter, we recorded a $3.4 million non-cash remeasurement adjustment to interest expense related to changes made to the OMIDRIA royalty obligation. This credit was $700,000 lower than a similar adjustment recorded in the fourth quarter of last year and is a primary driver of the increase in interest expense for the first quarter. Interest and other income totaled $1.1 million in the first quarter of 2025, compared to $2.3 million in the fourth quarter of last year. The decrease is primarily attributable to lower interest income and OMIDRIA reimbursement revenue from completion of our animal studies on addiction. Income from discontinued operations in the first quarter was $4.1 million, down $1.1 million from the fourth quarter. The first quarter total includes two primary components, $3.9 million of interest earned on the OMIDRIA contract royalty asset and $166,000 remeasurement adjustment to the contract asset. As previously discussed, royalties earned are recorded as a reduction of the OMIDRIA contact royalty asset on our balance sheet, rather than recognized in our income statement. OMIDRIA royalties for the first quarter totaled $6.7 million based on OMIDRIA net sales of $22.3 million. This compares to royalties of $10.1 million on fourth quarter net sales of $33.6 million, representing a decrease of $3.4 million in royalties and a reduction of $11.3 million in net sales quarter-over-quarter. And compared to the first quarter of 2024, first quarter 2025 OMIDRIA royalties decreased by $2.7 million corresponding to an $8.9 million decline in net sales. And as a reminder, in February 2024, we entered into an amended agreement with DRI under which they acquired the right to receive all U.S. OMIDRIA royalties payable by Rayner through December 31, 2031. Omeros retains all royalty rights to ex U.S. sales of OMIDRIA and we're entitled to receive all U.S. royalties on OMIDRIA sales from and after January 1st, 2032. In other words, all global royalty payments will accrue to Omeros beginning January 1st, 2032. Now let's take a look at our expected second quarter 2025 results. We anticipate that, overall operating expenses from continuing operations in the second quarter of 2025 will be lower compared to the first quarter of 2025, as we begin to pause on clinical development of zaltenibart and other programs. Interest and other income for the second quarter is expected to be approximately $625,000 and interest expense, excluding any non-cash adjustments related to the OMIDRIA royalty obligation should be around $7.6 million. This represents a non cash increase of $3.3 million from the first quarter, primarily reflecting the absence of significant non-cash adjustment tied to the OMIDRIA royalty obligation and incremental interest expense of about $370,000 associated with the newly issued 2029 convertible notes. The senior term loan transaction we closed in June 2024 included a $29.8 million gain resulting from repurchasing a portion of our 2026 convertible notes. Under GAAP, we were unable to recognize that gain immediately. The $29.8 million gain is deferred and amortized as a premium over the term of the senior loan reducing interest expense. Inclusive of the deferred gain, we calculate the annual effective interest rate to be 1.4%. We expect to incur $600,000 in interest expense on the senior term loan for the second quarter of 2025. And finally income from discontinued operations is expected to be in the $6 million to $7 million range excluding any non cash re-measurement adjustments to the OMIDRIA contract asset. With that, I'll turn it back over to Greg.

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.