Omeros Corporation (OMER) Earnings Call Transcript & Summary

Good afternoon, and welcome to today's earnings call for Omeros Corporation. [Operator Instructions] 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 1 week from today. I'll now turn the call over to Jennifer Williams, Investor Relations for Omeros.

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 quarterly report on Form 10-Q filed today with the SEC as well as our most recent annual report on Form 10-K. Today's call 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 now turn the call over to Dr. Greg Demopulos, Chairman and CEO of Omeros.

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 third quarter results and key corporate developments, followed by an update on our development programs. David will then provide more details on the financials before we open the call for questions. For the third quarter of 2025, Omeros reported a net loss of $30.9 million or $0.47 per share compared to a net loss of $25.4 million or $0.43 per share in the second quarter. The third quarter results include $8.8 million in noncash charges related to a mark-to-market adjustment of embedded derivatives associated with our debt. Excluding this charge, our adjusted net loss was $22.1 million and our adjusted loss per share was $0.34. Cash burn for the quarter was $22 million. And as of September 30, we had $36.1 million in cash and investments. During the third quarter, we continued to strengthen our balance sheet, including a registered direct offering that generated $20.3 million in net proceeds, was priced at a 14% premium to the market and was completed without warrant coverage. This financing supports our ongoing operation and commercial launch preparations. In October, we announced a definitive agreement with Novo Nordisk for an asset purchase and license transaction centered on our late clinical stage MASP-3 antibody, Zaltenibart. The deal is valued at up to $2.1 billion in upfront and milestone payments plus royalties in the high single-digit to high-teen percentages on global net sales. The transaction remains subject to customary closing conditions, including expiration of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act. HSR filings continued to be accepted during the government shutdown and the applicable waiting periods continued to run as usual during the shutdown. We anticipate closing later this quarter. Upon closing, Omeros will receive $240 million in upfront cash with an additional $100 million in achievable near-term milestones. With the upfront $240 million alone, we intend to fully repay our $67.1 million secured term loan, repay at maturity the remaining $17.1 million principal balance on our 2026 convertible notes and fund more than 12 months of post-closing operations including the anticipated U.S. launch of narsoplimab for the treatment of transplant-associated thrombotic microangiopathy, or TA-TMA. In exchange, Novo Nordisk will receive exclusive global rights in all indications to develop and commercialize Zaltenibart and certain related antibodies and antigen binding fragments. Omeros will, with certain exceptions, be broadly restricted from exploiting antibodies against MASP-3 as well as against other specific alternative pathway targets in a small number of indications that are of high priority to Novo Nordisk. Omeros retains rights to continue development and commercialization of our MASP-3 small molecule inhibitor program with only limited restrictions on indications. We've also retained rights to certain research antibodies and grandfathered MASP-3 antibodies with temporal and indication-related restrictions on commercialization. This transaction represents a strategic and financial milestone for Omeros. It provides capital to advance our other high-value programs, including MASP-2, oncology, T-CAT and PDE7 while validating the depth of our science and development expertise. Zaltenibart is a pipeline in a drug, and both companies expect it to become the premier alternative pathway inhibitor, significantly advancing Novo Nordisk's rare disease franchise. Novo is a global leader in therapeutic innovation and development. Its commitment and global reach will help fully unlock Zaltenibart's therapeutic potential, maximizing its benefits for patients. Let's turn now to our MASP-2 antibody narsoplimab, which when approved, will be marketed as YARTEMLEA. The Biologics License Application, or BLA, for the treatment of TA-TMA remains under FDA review with a December 26, 2025 PDUFA date. Because PDUFA reviews are funded by industry fees, the current government shutdown, which just ended, was -- is not expected to affect this time line. We remain optimistic for an approval decision by or before December 26. In Europe, the Marketing Authorization Application, or MAA, for YARTEMLEA in TA-TMA was validated in June by the European Medicines Agency, or EMA, and is under review by the committee for medicinal products for human use. We anticipate an EMA decision in mid-2026. While regulatory review proceeds toward anticipated approval of YARTEMLEA in both the U.S. and Europe, Omeros is preparing to execute on our commercial launch plan. Our U.S. commercial organization from leadership and market access to field teams and market development liaisons is assembled and launch ready. We've established a national ICD-10 diagnostic code for TA-TMA and an associated CPT procedural code specific to YARTEMLEA. Together, these position YARTEMLEA once approved as the only reimbursable TA-TMA treatment. We also expect to receive from Medicare a new technology add-on payment or NTAP to support hospital reimbursement. Engagement with transplant centers, payers and key hospital decision-makers on YARTEMLEA has been highly positive. This has been driven by the drug's demonstrated response and survival benefits, clean safety profile and clear dosing regimen. Our team stands ready to initiate the commercial launch of YARTEMLEA upon FDA approval. Awareness and support for YARTEMLEA in the transplant community continue to grow. Several recent publications in leading peer-reviewed journals by global transplant experts further strengthen the profile of YARTEMLEA specifically, its compelling survival outcomes and strong safety record. The first paper, survival in adults with high-risk TA-TMA, a comparative analysis of narsoplimab versus supportive care was published last month in Blood Advances, the Journal of the American Society of Hematology. It shows significantly improved survival in TA-TMA patients treated with YARTEMLEA, both in the pivotal clinical trial and the global expanded access program. compared to a well-matched external control group receiving standard supportive care. The second publication titled Narsoplimab Results and -- excellent Survival in Adults and Children with Hematopoietic cell transplant-associated thrombotic microangiopathy appeared earlier this month in the American Journal of Hematology. It reports strong survival outcomes in patients treated under expanded access with the YARTEMLEA used as both first line and as salvage therapy in those who failed one or more prior regimens with other complement agents, including C5 inhibitors and/or defibrotide. Importantly, no safety concerns were identified. consistent with all prior YARTEMLEA studies. The third paper also published last month in the American Journal of Hematology focused on increasingly recognized safety concerns with the use of off-label C5 inhibitors. The study by [indiscernible] at Emory University looked specifically at the C5 inhibitor eculizumab in pediatric TA-TMA and reported a remarkably high infection rate. In this prospective matched analysis, eculizumab-treated patients showed an 8.5-fold increase in bacteremia. And about a sixfold increase in infection-related mortality compared with controls. This likely reflects the mechanism of C5 inhibition, which impairs host defense. In contrast, MASP-2 inhibition by YARTEMLEA preserves immune protection. With the YARTEMLEA approval decision approaching in TA-TMA, we've identified other commercially attractive MASP-2 related indications for our pursuit. Our MASP-2 franchise includes YARTEMLEA optimized for acute conditions like TA-TMA; OMS1029, our long-acting MASP-2 antibody for chronic diseases designed for dosing as infrequently as once quarterly and our MASP-2 small molecule inhibitors intended for those indications in which once-daily oral dosing would be preferable. OMS1029 is Phase II ready with both active drug and placebo already manufactured and released. Our lead small molecule MASP-2 inhibitor is close to beginning IND-enabling studies. Okay. Turning now to programs beyond our complement franchise. Our PDE7 inhibitor program evaluating OMS527 for cocaine use disorder continues to progress under a fully funded grant from the National Institute on Drug Abuse, or NIDA. Animal cocaine interaction studies designed with NIDA toxicologists have been completed and show no drug interaction or safety issues, supporting the planned inpatient human study in cocaine users. FDA has requested additional preclinical information, and we now expect to begin this inpatient clinical trial in the second half of 2026. We are also advancing our targeted complement activating therapy, or T-CAT platform, a new class of pathogen targeting recombinant antibodies designed for broad action against bacteria, fungi, viruses and parasites. T-CAT represents a novel approach to infectious disease treatment, harnessing complement activation to kill pathogens directly. As preclinical animal data continue to accumulate across multiple pathogen classes and species, excitement continues to grow among infectious disease experts, particularly regarding T-CAT's potential against multidrug-resistant organisms or MDROs. These pathogens represent a global health crisis with enormous mortality and cost burdens. Effective MDRO therapies remain one of the most urgent and unmet needs in medicine and T-CAT has the potential to address it without contributing to drug resistance. Finally, turning to our oncology platform. Our Oncotox biologics program is advancing rapidly with acute myeloid leukemia, or AML, as the lead indication. Our Oncotox AML therapeutic has consistently shown superior efficacy to current standard of care treatments, both in vivo in human tumor-bearing mice and in vitro in human AML cell lines. Our Oncotox therapeutics demonstrate broad activity across AML genotypes, including TP53, NPM1, KMT2A and FLT3 mutations. A nonhuman primate safety study is underway with encouraging results to date. Guided by our clinical steering committee of AML leaders, we remain on track to enter the clinic in 2027. That concludes our financial corporate and development program update. I'll now turn the call over to David Borges, our Chief Accounting Officer, for a detailed description of our financial results. David?

Thanks, Greg. Our net loss for the third quarter of 2025 was $30.9 million or $0.47 per share compared to a net loss of $25.4 million or $0.43 per share in the second quarter of this year. Third quarter results include noncash charges of $8.8 million associated with marking to market our embedded derivatives related to our debt. Excluding this charge from current quarter results, our adjusted net loss was $22.1 million and our adjusted loss per share was $0.34 per share. The $8.8 million charge is solely a noncash remeasurement adjustment and removing it provides a more accurate measure in gauging the company's operating performance. As of September 30, 2025, we had $36.1 million of cash and investments on hand. And as Greg mentioned, we closed a registered direct offering in July in which we received net proceeds of $20.3 million. We also raised net proceeds of $9 million from our ATM program during the quarter. The closing of our agreement with Novo Nordisk, which is expected to occur in the fourth quarter of this year, will provide Omeros with $240 million in upfront cash. At closing, a portion of the proceeds will be used to fully repay all outstanding obligations under our secured credit agreement. This includes the $67.1 million outstanding under the term loan, along with an applicable prepayment premium and accrued interest. The repayment will eliminate all liens covenants associated with the credit agreement, including the $25 million minimum liquidity covenant. In connection with the May 2025 conversion of our 2026 convertible notes, we exchanged $70.8 million in aggregate principal amount of those notes on a one-for-one basis for newly issued 2029 notes, extending the maturity to June 2029, a period more than 3 years out. Additionally, we reached agreements with 2 holders to convert $10 million of their 2026 notes to Omeros's common stock, which was completed in September 2025. Following these transactions, [indiscernible] the principal balance of our 2026 notes has been reduced from $97.9 million to $17.1 million, which becomes due in February 2026. After repayment of the $67.1 million term loan and the $17.1 million of the '26 notes, the company's only remaining debt will be $70.8 million of the 2029 notes, which again are not due until June of 2029. Costs and expenses from continuing operations for the third quarter before interest and other income were $26.4 million, which was a decrease of $6 million from the second quarter of this year. Research and development expenses in the third quarter were primarily focused on Zaltenibart and YARTEMLEA. The primary components of interest expense include the 2026 notes, the DRI OMIDRIA royalty obligation, the secured term loan and the 2029 notes. For the third quarter, interest expense was a net credit of $13.4 million, primarily due to a $22.3 million noncash remeasurement adjustment related to our DRI OMIDRIA royalty obligation. This adjustment reflects updated forecast of royalty receipts provided by Rayner. Excluding the DRI royalty obligation, which is entirely pass-through interest from Rayner to DRI and amortization of debt issuance cost, discounts and premiums, contractual cash interest expense was $4.2 million compared to $3.9 million in the prior quarter. The increase was due to higher interest on the '29 notes relative to the '26 notes. Interest and other income totaled $616,000 in the third quarter of '25 compared to $1.2 million in the second quarter of this year. During the third quarter, we reported an $8.8 million noncash loss on marking to market our embedded derivatives related to our debt. Our derivatives are primarily comprised of a put call option on our unsecured 2029 notes and represents the conversion and interest make-whole features available to holders, allowing them to convert the notes into common stock. The loss from discontinued operations in the third quarter was $9.7 million, a decrease of $10.1 million from the second quarter. This decline was primarily due to a remeasurement adjustment stemming from Rayner's downward revision of its forecast for U.S.-based royalties of OMIDRIA. As a result, we were required under GAAP to revise downward our OMIDRIA contract royalty asset and our DRI OMIDRIA royalty obligation. As a reminder, in February 2024, we amended our agreement with DRI, granting them rights to all U.S. OMIDRIA royalties from Rayner through December 31, 2031. Omeros retains royalties from ex U.S. sales and will receive all global OMIDRIA royalties starting January 1, 2032. It's important to note that the bulk of these transactions involve U.S.-based royalties, which are pass-through in nature and net cash neutral to Omeros. Rayner remits these royalties to DRI via an escrow agent. However, because both Rayner and DRI are contractual counterparties to us, we are required to recognize these amounts as assets and liabilities on our balance sheet. Now let's look at our expected fourth quarter 2025 results. We expect that overall operating expenses from continuing operations in the fourth quarter of 2025 will be higher than the third quarter, primarily due to increased marketing costs associated with the anticipated launch of YARTEMLEA. Research and development expenses in the fourth quarter are expected to be consistent with those in the third quarter of this year. Interest income in the fourth quarter should be slightly higher than in the third quarter, primarily due to higher average cash balances. Other income will be significantly higher this quarter, reflecting the expected gain on the Novo transaction after related expenses. In addition, we expect to record a noncash gain upon repayment of our term loan related to the removal of the unamortized premium and debt issuance costs and an embedded derivative associated with that instrument. Interest expense, excluding any noncash adjustments related to the OMIDRIA royalty obligation and amortization of debt discounts and issuance costs should be around $8 million. This represents a noncash increase of $23.1 million from the third quarter, primarily reflecting the absence of a significant noncash adjustment tied to the OMIDRIA royalty obligation. One thing to keep in mind, our reported results will continue to reflect noncash mark-to-market adjustments on the embedded derivative tied to our debt. These adjustments generally move with our stock price and can create volatility quarter-to-quarter because they're noncash and unpredictable, they're excluded from our adjusted net loss and don't affect our operational guidance. And finally, income from discontinued operations is expected to be in the $5 million to $6 million range, excluding any noncash remeasurement adjustments to the OMIDRIA contract asset. With that, I'll turn it back over to you, Greg.

All right, David. Thank you. Operator, would you please open the call to questions?

[Operator Instructions] Our first question comes from Brandon Folkes with H.C. Wainwright.

Congrats on all the progress in the quarter. Greg, I want to just understand sort of post approval kind of till launch and sort of maybe until we see significant revenue pull-through on narsoplimab. Once you gain approval, maybe when would you look to launch? Do you need to get into any guidelines? Or can you just begin detailing narsoplimab at launch? And then can you just help me understand selling to these transplant centers? Is it a sort of similar process to the hospitals in terms of formularies? Anything you can help just in terms of thinking about this launch activities post approval?

Sure. Well, as -- thank you, Brandon, first of all. As I mentioned in the prepared comments, those launch preparations are already well underway. The expectation is upon what we expect and hope will be an approval, we would move very quickly to launch the product. With respect to revenues, we do not -- as you know, we just customarily don't talk about our revenue projections for a reasonable period of time until we're able to see the same revenue trend lines that everyone else is. So I'm going to beg off of the revenue question other than to say that we believe that through the Novo transaction and the narsoplimab or YARTEMLEA approval that we would expect to potentially be cash flow positive in '27. So that is how we're viewing it. Also, I think with respect to your question regarding hospitals and formularies, let me turn that question over to Nadia who will be able to give you, I think, more detail.

Thanks, Greg. As we've said on previous calls, we've identified and prioritized accounts that we call ready to go. And in the accounts, we know the exception process to the formulary, and we know a champion already exists for TA-TMA and is eager to have an approved treatment. So formulary approvals will happen over time, but they're not critical to actually having narsoplimab ordered and administered to patients in those hospitals. And we do have a process that we will be providing the formulary kits and walking the P&T committees through, but that will be happening in parallel.

Thank you, Nadia. Brandon, does that cover it?

Our next question comes from Steve Brozak with WBB Securities.

I just want to got used in narsoplimab this many years. YARTEMLEA is now, I guess, the new way to describe it. You mentioned something on the call and in the press release on NTAPs. I'm familiar with some previous NTAP awards and you say that you would expect -- can you give us as much detail as you can on the NTAP section? Because obviously, it's a good way for hospital systems to get additional payments. So what can you tell us about it and your estimation of how it will work for YARTEMLEA?

Sure. Again, I'll answer that in general and then hand that over to Nadia as well. But as you know, the NTAP provides assistance in payment or subsidizes payments in the hospital setting, so to the hospital. And we have -- we are in the process of applying. And we do expect that we will receive, as I said, an NTAP for YARTEMLEA. So I think that is intended to obviously be helpful within the hospital system to help defray the cost of the drug when DRGs have not yet obviously adjusted to the additional cost of a drug like YARTEMLEA in TA-TMA. So that's the purpose. Let me hand it over to Nadia, who can give a little detail about perhaps next steps, time line, et cetera.

Yes. So you described it well. And we're very proud of the fact that we submitted on time. And as CMS has publicly shared, they will have a town hall in December, where we are prepared to present our data there. And then the decisions, which we're very confident in a positive decision would then go into effect in their fiscal year that begins in 2026.

Our next question comes from Olivia Brayer with Cantor.

Congratulations on the recent Novo deal. Can you comment, Greg, on whether or not you all have had labeling discussions with the FDA yet? And is there anything that we should be taking into consideration as we think about what a potential label might look like just based on the historical control analysis that you ran? And then I did have a quick question on that historical control database. I noticed that those data from the Kyoto transplantation group are from 2000 to 2016. Is there any reason that it didn't include data from beyond 2016?

Sure. Let me take those questions, I believe, in order. I caught the first and the third, but I may ask you then to repeat the second. So maybe I'll go 1, 3, come back to 2. With respect to labeling, we do not -- I mean, just historically and consistent with Omeros guidelines, we really just do not comment on play-by-play discussions with FDA. With respect to -- well, your question about the Kyoto data and the years that those data were collected, frankly, there's good overlap with the data from our trial. And the reason that those data are running that time frame for Kyoto is, remember, those data came -- the initiation of accessing those data came from the publication. And the Kyoto stem cell transplant group pulled all those data from 17 different institutions throughout Kyoto. So the amount of data that is really well beyond anything that we could find anywhere else, not only the amount of the data, but frankly, the quality of the data. Significantly beyond what we would have been able to grab or could grab since we actually attempted this from CIBMTR, EBMT, none of those really collect the patient level data and the specificity detail of TA-TMA. So that's how those data were collected. That's really what's driving the time frame, but I'll come back to my initial comment, which is that the overlap is there between our patients treated and the Kyoto patients. And [ Kathy ] do you want to have any further statement on that?

Well, on the Kyoto, as you said, Greg, the database was collected very rigorously up to a particular point and published. And so to try to start that up again would certainly take years. And if you ask me to comment on the first question, again, the communications with FDA have been interactive and collaborative. And we've been able to provide FDA what they've asked for in their information request.

Okay. And I'm sorry, Olivia, the third, I caught something about what it might look like with respect to the control. You're speaking about what we would anticipate labeling looks like with.

Is there anything for us to kind of keep in mind as we go into that PDUFA and as we potentially get a label in December?

No. I mean, again, I just will -- I'll just default back to the same answer, which is that we don't discuss labeling. We don't discuss the play-by-play interactions with FDA. We just don't think, frankly, that's a wise thing for Omeros to do. But look, I'm going to speak now generally about the data that we have provided to FDA. We've provided adult data. We have also provided substantial pediatric data through the expanded access program. Certainly, our objective would be to include both adult and pediatric patients in any kind of label. I think that, that is clear. And I think we've said something to that same effect previously.

Our next question comes from Serge Belanger with Needham & Co.

This is John on for Serge today. So first, just to piggyback a bit on the previous question. Curious whether there's been any recent FDA commentary to you guys on your data package and the use of historical controls. I only ask again just trying to gain some clarity around it, considering some of the recent CRLs have come out for products that use historical controls. And then second, on operating expenses. Just curious whether you're at steady state there or expect changes heading into 2026. You mentioned there should be a little bit of a bump in 4Q this year. Curious what your outlook is for '26.

Yes. First, with respect to our interactions or information requests, whatever may come from FDA, we're in a review process. One would expect that throughout that period, information requests come, information requests are responded to in a timely manner. And I don't think it's any different for our application than for any others. So I think that, that is -- that's pretty clear. I think that the other products, which have run into issues around historical controls, I think you may be referring to potentially, is that the Biohaven product that you're referencing?

Yes, that's correct. And [indiscernible] also uniQure as well.

UniQure and Biohaven. Yes. I mean when you look closely at those, John, it's a very different situation, I think, than what we have. And I think it's very different broadly than just kind of pointing out historical control, historical control. Therefore, these 2 things must be the same. Those are very different products. I think the packages are -- we haven't seen all of the package for either of those products, either UniQure's or Biohaven. They haven't made those public. But what is there publicly, I think, makes it pretty clear that there are differences here. So we really don't see those as having any impact or any meaningful impact on our application or on our drug. With respect to our expenses moving into '26, I would expect, again, that I think as David went through, those we would expect to increase. But again, everything is being predicated on really 2 events. One is the closing of the [indiscernible] and the second is the approval decision from FDA. And we can dial up or dial down as needed. But certainly, what we're expecting to do are sort of the things that I went through in the prepared comments. I mean there are a number of programs that we intend to push. And those include 1029 -- they include MASP-2 small molecules as well. They include our PDE7 program, our T-CAT program. And they very much include what we have as our oncology platform. We're really excited about all of these programs. But I think there's a breadth of applicability across each of these programs. But we are excited. And we do expect at some point to share more information on these programs. I would just sort of say, stay tuned. And we'll share information as it becomes available and appropriate to share. Did that satisfy, John?

I'm showing no further questions at this time. I would now like to turn it back to Dr. Demopulos for closing remarks.

All right. Thank you, operator, and thanks to all of our analysts for their questions. Before ending today's call, I'd like to just step back and reflect on what's been accomplished and what lies ahead. Today, Omeros is entering one of the most exciting phases in our history. With YARTEMLEA approaching an approval decision, we're preparing to deliver the first and only approved treatment for TA-TMA, a therapy that we expect will really transform outcomes for transplant patients worldwide. The continued recognition from the global transplant community highlights the impact we expect YARTEMLEA to have once launched. Equally important, our strategic transaction with Novo Nordisk underscores the scientific and value of our complement franchise. This collaboration not only provides substantial nondilutive capital, but also brings the strength, scale and expertise of one of the world's leading biopharmaceutical companies to accelerate and expand the reach of Zaltenibart and MASP-3 inhibition globally. It is a strong external validation of our science, our platform and our team's ability to translate innovation into long-term value. At the same time, we continue to advance a deep and diversified pipeline. from OMS1029 and our MASP-2 small molecules to our PDE7 program, the T-CAT platform and our oncology franchise. Each targets major unmet needs and carries significant potential to create both clinical and shareholder value. Our focus now is clear, securing YARTEMLEA approval, executing a successful commercial launch and driving forward the next wave of programs that will define Omeros' future. We are scientifically differentiated -- and upon closing, the Novo Nordisk transaction will be financially strong and well positioned to deliver sustained growth. I want to thank our employees for their dedication, our collaborators and partners, including Novo Nordisk, for their confidence in our science and our shareholders for their continued support. We look forward to updating you again as we continue to execute on what we expect will be a truly transformative period for Omeros. Have a good evening.

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