BioCryst Pharmaceuticals, Inc.

Good day and welcome to the BioCHRIST fourth quarter 2025 conference call. All participants will be in listen-only mode. Should you need assistance, please signal a conference specialist by pressing the star key followed by . After today's presentation, there will be an opportunity to ask questions. To ask a question, you may press star then one on your telephone keypad. To withdraw your question, please press star then two. Please note this event is being recorded. I would now like to turn the conference over to Nick Bielder with Biochrist. Please go ahead.

Good morning and welcome to Biochrist's full year 2025 corporate update and financial results conference call. Participating with me today are President and CEO Charlie Geyer, Chief Financial Officer Bob Ruggias, and Chief Development Officer Dr. Bill Sheridan. A press release and slide presentation about today's news are available on our investor relations website. Today's call may contain forward-looking statements, including statements regarding future results, unaudited and forward-looking financial information, as well as the company's future performance and or achievements. These statements are subject to known and unknown risks and uncertainties which may cause our actual results, performance, or achievements to be materially different from any future results or performance expressed or implied in this presentation. For additional information, including a detailed discussion of these risks, please refer to slide two of the presentation. In addition, today's conference call includes non-GAAP financial measures. For a reconciliation of these non-GAAP financial measures, against the most directly comparable GAAP financial measure, please refer to the earnings press release available on our investor relations website. I'd now like to turn the call over to Charlie. Thanks, Nick.

This is my first earnings call as CEO of Viacryst, and I'm happy to report, happy about where the company is today, and even more excited about our future. We closed 2025 with strong momentum, delivering full-year Orlodeo revenue of $601.8 million. That was up 38% for the year and 43% when you exclude our Europe business that we sold in October. We are also starting 2026 on a high note as we expanded our HAE portfolio with our acquisition of Astrea Therapeutics last month. As I step into my new role, I want to be clear about BioCris strategy. We are and will remain a profitable rare disease company committed to meeting the unmet needs of patients through commercialization innovation and excellence that is backed by well-understood biology and disciplined clinical development. Where we will continue to evolve is how focused and explicit we are about capital allocation and accountability. We want to ensure that every dollar we deploy has a clear line of sight to driving long-term value creation. Coming back to our HAE portfolio, we see tremendous opportunity to build value by meeting the needs of a growing number of HAE patients. We view HAE not as a winner-take-all efficacy race, but as a structurally segmented market driven by biology, patient preference, and real-world experience. Rather than a market that resets with every new entrant, we see a market that segments based on the needs of individual patients. We now have a portfolio of differentiated products in Orlodeo capsules for ages 12 and up, Orlodeo pellets for younger kids, and a late stage asset in the Venobarb. Each of these therapies will allow us to achieve growth and durable revenue within specific segments of the market. Orlodeo has grown strongly in part because of its differentiation as the oral option. But more importantly, there is a super responder population that can get injectable-like attack control. We saw in our pivotal trial that just over 50% of patients starting on Orlodeo stayed on for two years and had a 91% reduction from baseline. In the real world, 60% of patients stay on therapy through 12 months, and nearly 50% of all patients who have tried Orlodeo in the U.S. over the past five years are still on therapy. Most Orlodeo super responders are unlikely to switch, even if another oral option reaches the market, because their needs are already met. And now we have a new member of the Orlodeo family. We are excited to launch Orladeo pellets for kids ages 2 to under 12 at the Quad AI Conference this weekend. The unmet need is significant because HAE and related attacks are underdiagnosed in younger kids, and prophy usage is only half that of adults. Availability of a safe, effective, and targeted oral prophy has the potential to change how kids with HAE grow up. and Orlodeo is likely to be the only oral option for several years to come. We think about Nivenibart through that same lens of structural differentiation in HAE. Nivenibart is not intended to replace Orlodeo. It is intended to allow Biochrist to address patients' needs across the full spectrum of efficacy, dosing, and convenience preferences in HAE prophylaxis. There are approximately 5,000 U.S. patients who have great attack control by injecting anywhere from twice a week to every four weeks. Most of them are reluctant to take a chance on oral because they are well-controlled already, and the injections themselves are not a barrier to treatment. Oral is not their need. But our research shows that many are very attracted to the idea of a simple, high-efficacy injectable, dosed just two or four times per year. That is a leap patients dosing an injectable 12, 26, or even over 100 times per year are likely to make because it aligns with what they know and provides something better. Our objective is to keep the HAE prophylaxis treatment decisions within the BioCrisp portfolio. That is another way we think about long-term durability, not as defending a single product, but as owning the prophy decision framework in HAE. we will offer three compelling options, all from a team that the HA community knows and trusts. Before turning to Bill, I want to briefly touch on BCX17725, our early stage program in Netherton Syndrome. This is a classic rare disease story, a devastating genetic condition that is underdiagnosed because there are no good treatment options. We are encouraged by the results and healthy volunteers and the investigator enthusiasm for this program. We're on a path to generate clinical data in patients by the end of the year, and we'll use that evidence plus feedback from patients and investigators to guide next steps. Looking ahead to 2026 and beyond, we see durable revenue growth anchored by a skilled, motivated, and resilient commercialization team meeting the needs of adults and kids who want oral HA prophylaxis. a second molecule advancing well in late-stage development that has the potential to lead the injectable prophylaxis segment, and additional rare disease optionality in our pipeline, positioning Viacryst for sustained value creation. With that, I'll turn it over to Bill to provide more color on our pipeline.

Thank you, Charlie. I'll cover our HAE programs to start with and then provide a brief update on our Nevitin syndrome program. The Naventabart Pivotal Phase III trial continues to recruit very well, with strong enthusiasm for the study from investigators and potential trial patients. We expect a complete enrolment of the required 145 patients around the middle of 2026. The primary efficacy analysis of the Alpha Orbit Pivotal trial will be the comparison between each Naventabart dosing regimen and placebo, of the time-normalized rate of investigator-confirmed HAE attacks through six months. The Phase 2 efficacy and safety profile that we are reporting at Quad AI this weekend from the Alpha Solar trial is excellent with no safety signals in 29 patients through up to 24 months of dosing and reductions from baseline in mean attack rates of 92% for every three months dosing and 90% for every six months dosing. Overall, the mean attack rate decreased from 2.23 per month at baseline to 0.16 per month during the Nevenabar treatment. For both dose regimens, the median attack rate reduction was 97%. These are outstanding results. These strong results illustrate the durability, consistency and quality of treatment responses with Nevenabar. and provide high confidence that the Pivotal Trial will be successful. We expect the Pivotal Trial results to confirm that the VeneBART every three months or every six months will set a new standard in the field and provide a very attractive choice for HAE patients seeking injectable prophylactic therapies. Second, we are thrilled that our application for Oladeo Oral Pellets for Children aged 2 to less than 12 was approved by FDA in December 2025. We are now continuing with marketing authorisation applications in other major regions with the goal of transforming treatment choice for patients, for parents and children with HAE around the world. Third, our clinical development program for our KOK5 inhibitor, FC fusion protein BCX17725 in evidence syndrome, has now moved into patient-focused research. The healthy volunteer parts one and two of our phase one trial with single and multiple ascending doses have been completed. BCX17725 was administered by subcutaneous and intravenous routes in these healthy volunteer cohorts. Our investigational drug was safe and well tolerated. There were no discontinuations, no dose-related adverse findings and no safety signals. The top dose administered was 12 milligram per kilogram every two weeks for three doses and as noted in our last call we were pleased to see evidence of the drug distributing to the epidermis. Drug exposure was approximately linear and proportional to dose and the estimated half-life was about 12 to 19 days supporting continued study of every two week administration schedules. Today I'll provide a refresher on study design and update on progress in the Nevadans Syndrome cohorts. The study design is outlined on slide 18. The patient cohorts in the study are open label and designed to evaluate potential effects of the drug on clinical signs and symptoms of Netherden syndrome as well as safety and drug exposure. There are two patient cohorts, a short term administration cohort in part three with four weeks of dosing and a longer term cohort in part four with 12 weeks of dosing. Some sites are activated for part three after short-term non-clinical safety studies were completed and subsequently were activated for Part 4 once we had longer-term non-clinical safety studies done. We are prioritising recruitment into Part 4 as this will give us a longer dosing experience and anticipate that no more than three patients will be entered into Part 3. Our clinical investigators are excited about the potential for this drug in Everton syndrome and have identified patients who could be eligible. so we expect to recruit up to 12 patients in Part 4 and generate results by the end of this year. For efficacy, the primary efficacy endpoint is change from baseline in the ichthyosis area and severity index otherwise known as the IASI score and key secondary endpoints include the Investigative Global Assessment score and the Worst Itch Numerical Rating Scale score and we will also evaluate quality of life metrics We intend to select doses and endpoints for a pivotal trial based on what we see in this phase one trial. I'll now turn the call to Baba for the financial review.

Thanks, Bill. Last year was a defining year for our company. We delivered strong top-line growth, record profitability, and reinforced our strong balance sheet position. Those results weren't just numbers. They were proof that our strategy is working and our operating model is built for scale. Before I turn to financials, I want to highlight that we are providing more clarity in our financials to enable a better understanding of the strength of our core business. Please refer to today's press release for our GAAP financial metrics. In my remarks, I will be referring to non-GAAP figures, which are adjusted for the sale of the European holiday business, stock-based comp, workforce reduction costs, and transaction-related costs. We believe that non-GAAP figures provide a clearer view of the business on a forward-looking basis. Our non-GAAP 2025 total revenue increased 45% year-on-year. Since other revenues include contribution from RappiVap, which is non-co to our business, I would draw your attention to the non-GAAP Oledeo revenues, which increased by approximately $169 million, or 43% year-on-year. This was a result of phenomenal day-to-day execution by our commercial team over the course of 2025. By leveraging our superior real-world evidence generation capabilities, we successfully drove higher patient volume and made significant progress on paid shipments. We have already started to see the impact of the European divestiture on our operating performance in Q4. Our non-GAAP operating profit jumped to $214 million, an increase of 198% year-on-year, highest ever in Biochrist history. R&D costs came down slightly in 2025 as we progressed key programs while winding down some others and realigning the team structure. We anticipate that 2026 R&D costs will increase over 2025 as we complete the ongoing phase three trial and PLA enabling CMC activities for Novena Bar. These activities once complete will naturally bring down development costs beyond 2026. We will remain razor focused on maintaining R&D spending discipline and allocating capital to high ROI opportunities. In the same spirit, we will quickly terminate programs that do not have a compelling path forward. Our sales and marketing expenses for the year were $144 million on a non-GAAP basis, which were primarily up due to some reallocation methodology, pre-launch costs for pediatrics, and higher specialty distribution fees and incentive comps naturally owing due to the strong top-line growth. More importantly, as you can calculate, that for every dollar invested in our sales and marketing engine, we generated an approximately four times return on Oladeo net sales. While we do anticipate some small incremental annual expense tied to top-line growth, the ROI on Oldadeo will continue to expand as we drive the business toward its blockbuster potential. Looking further ahead to potential approval of Navanavart, the sales and marketing expense supporting our HAE franchise as a whole will be very stable, predictable, and carry an even greater ROI upside. We have built one of the best rare disease commercial organizations in the industry. a highly scalable infrastructure that will enable us to deliver multiple successful launches in years to come in HAE and beyond, whether it's another candidate from our pipeline or something that we acquire in license. Driven by our strong operational results, we finished the year with a formidable liquidity position of $337.5 million in cash and investments on hand. Concurrent with the closing of the ASRI acquisition, we entered into a highly attractive $400 million financing facility with Blackstone Life Sciences, a financial partner that is aligned with our vision of growth. With the sustained momentum coupled with the added benefit that now for the next two years, we will be able to utilize our prior period tax annuals, we will be in a very strong cash flow generating position. This will afford us optionality to evaluate a wide array of capital allocation strategies that reinforce durable value creation, be it M&A, debt pay down, or buybacks. Moving on to guidance. We are maintaining expectations for full year 2026 OLEDEO revenues to be between 625 million and 645 million, which at the midpoint represents approximately 13% growth over 2025 revenues adjusted for Europe. We expect full year 2026 non-GAAP OPEX to be between 450 million and 470 million, which now includes expenses on ASHRAE as previously guided. As Charlie emphasized, we remain very confident that Oldeo is in a solid footing to achieving blockbuster potential. We continue to see patient growth driven by the trends that we explained earlier, coupled with the recent pediatric approval, which will be an important component of the growth. After turning over this profitability card in 2025, we are very committed to staying profitable and continuing to drive cash flow generation going forward. To summarize, As we reflect on 2025, it is clear that the strength we delivered this past year is more than a financial milestone. It's a springboard for what comes next. We are entering 2026 with momentum, a sharpened competitive edge, and a discipline that ensures every investment we make is working towards value creation. Our goal is to keep advancing our pipeline through both organic innovation and selective discipline VD that can expand our capabilities and accelerate our impact in the rare disease space. We are very excited to keep building the next growth phase of Biochrist, a company that not only performs quarter to quarter, but compounds value over the long term as we execute on that vision. Operator, we are now ready for your questions.

We will now begin the question and answer session. To ask a question, you may press star then one on your telephone keypad. If you are using a speakerphone, please pick up your handset before pressing please. If at any time your question has been addressed, If you would like to withdraw your question, please press star, then two. At this time, we will pause momentarily to assemble our roster. Our first question comes from Laura Chico with Wedbush Securities.

Please go ahead. Good morning, guys. Thanks for taking the question. I guess I wanted to start off on Novena Bart. Could you talk a little bit more about the timing for the regulatory submission by year end 27? Does that assume phase three data is still arriving by early 27? And I guess I just wanted to understand the steps that have to occur between top line data and submission. And then related to that, you mentioned the Quad AI late breaker. How should we think about this, I guess, in relation to AlphaStar? It seems quite consistent in terms of the attack rate reductions. I'm wondering if there's incremental learnings here around maybe attack-free periods. Thanks very much.

Thanks, Laura. Yeah, we're clearly super excited about Navinabart. Yes, everything is on track for filing such that we would be on track for filing by the end of next year, and so on track for approval by late 2028. Bill, do you want to answer the question just about the regulatory process?

Sure. Like for other prophylactic therapies in HA, 12 months, it's a chronic condition. You need 12 months of safety that will be delivered in. mid-27, and that's really what's driving the timing of the DLA submission. And what was the final question?

And then the final question, just the data, yeah, we're really excited about the data. The 92% reduction, mean reduction for the three-month dose, the 90% for the six-month dose just shows incredible consistency. And I think what's also really important is the mean attack rate of 0.16 across the population from their baseline. you know, that's less than two attacks per year for patients. And so what that means is, and plus the severity of the attacks went down as well. So for most of the year, patients are functionally attack-free, and that's what patients are looking for.

Thanks very much. I'll hop back in the queue.

Our next question comes from Brian Abrams with RBC Capital Markets. Please go ahead.

Hey, good morning, guys. Thanks for taking my questions. Congrats on the continued strong harvest. You talked a little bit about the Orlodeo super responders, you know, staying on with, you know, good persistence for long periods of time. I guess, do you have any sense of how to predict who would be a super responder? And then just maybe along those lines, I'm curious how you envision positioning Nevada BART in that context in terms of you know, do you push patients to switch to Orladeo, and then if they don't respond, you know, they could, you know, Navetabart could be an option for them, or would you be primarily positioning Navetabart for those, you know, 5,000 patients doing well on injectables who could use something that's less frequently dosed? And then just maybe remind us of some of the aspects of the profile for Navetabart in terms of numbers of injections, anti-drug antibodies, refrigeration requirements, just anything else that needs to be done with regards to formulation ahead of commercialization. Thanks.

Great. Thanks, Ryan. I'll start, and then I'll have Bill answer some of those questions as well. As far as the predictability of the super responders in Oradeo, there really is no way to predict other than patients trying. So first of all, patients kind of want to be on an oral, and we know that the majority of patients actually would prefer an oral. But as we've looked at all of our clinical data, all the different factors, age, sex, prior prophy history, weight, everything else, there is nothing that can predict who is going to respond. As we know, HAE attacks are often driven by stress, other life factors. And so I think, you know, our strategy is to try to get patients who are interested in oral to try. Most of them do great. We want them to do a three- to six-month trial to really figure out if it's the right drug for them. And as we see, you know, by a year, about 60% of them realize that it is the right drug for them. As far as the Novena part positioning versus Orlodeo, We see the primary opportunity for Nivenibar to be those 5,000 patients on injectables. Like I said in my remarks, those patients are on injectables because they're doing well, but some of them are injecting 100-plus times a year. And so to be able to do just two to four injections we think is going to be really compelling, and that's what we see in our patient research. So Orodeo, then, is going to be for patients who want to start profi, On oral, it's going to be the known, the trusted option with many years of data and experience. And so Orlideo is for anyone who wants oral. Nevenobar is for people who want an even better injectable positioning. And then for those patients who try Orlideo and it's not the drug for them, That also is an opportunity for Novena Bar all within the same Biochrist portfolio. For Novena Bar, the number of injections is really going to be very simple. So it's going to be launched with an auto-injector, and the three-month dose after a 600-milligram loading dose, which will be two injections, two milliliter injections, the three-month dose is then one injection. The six-month dose is two injections. So very, very simple. And then Bill, there was also questions just around ADAs and other things that... Yeah.

Before I get into that, with regard to predictability, I'll just reinforce what Charlie said. You have to try all the data to find out whether you're going to be a super responder. And so it benefits people in every category with HAE. So in addition to age, sex, race, weight, prior prophy exposure... You can also add to that whether you have a high attack rate or a low attack rate, whether it's less or more predictable, whether you have type 1 or type 2 HAE or C1 inhibited normal HAE. All of those categories benefit and we've shown that very definitively from both our clinical trials and our real world evidence studies. You also asked about the maturity of the formulation development program from AvenaBAR. It's all done. It's very mature. CNC is in a great spot. And just a question about ADAs. With regard to ADAs, there's no evidence of ADAs impacting efficacy in the Phase 2 experience. And, you know, of course, with every biologic, it's part of the development program that you develop assays and look for ADAs. You always find them. And what matters is Do people continue to benefit from the drug? And so far, that is exactly the case. There's no evidence of ADA impacting either safety or efficacy.

And just to remind folks, the data being presented this weekend, these are patients on the Venobar who are out to as far as 24 months with a mean of about 12 months. So one last thing about the injections, they don't hurt.

Yes.

That's really helpful. Bill, Charlie, thank you guys so much. Thanks, Brian.

The next question comes from Steve Seathouse with Cancer Fitzgerald. Please go ahead.

Yes, hi. This is Timur Ivanovic on for Steve. For Netherton, we just wanted to clarify, are you guys going to be releasing Part 3 and 4 data at the same time? And then also, could you talk about disease severity, the variability at baseline, Do you anticipate how difficult would it be to enroll variable patients, I mean, more uniform patients? And then, you know, what background treatments are allowed and how patients proceed based on their disease phenotype? Thank you.

Okay. I'll start with just the Part 3 and 4, and then Bill can talk about the disease severity and and the patient types. Our plan is to release all the data together. We're only going to have maybe two or three patients in part three, and as Bill said, we're now prepared across our sites to go into part four, and that three-month dosing is what we think is really going to be meaningful. So we don't plan to do one patient at a time. We want to release a complete data set. And then Bill, just talk about the patients.

With regard to the spectrum of severity, there is one, for sure, in Netherland Syndrome. What we're finding from our research onto the prevalence of disease, for example, is, like Charlie said, it's underdiagnosed, and that's probably partly because they're – mostly because there are no approved treatments, but also because of the differences in severity from one patient to the next. The patients we've met with this illness have obvious, really obvious disease, and they have adapted coping strategies. that their lives have been dramatically impacted. That part of it I'm not worried about in terms of recruiting subjects. So the investigators that we have that are lining up their subjects are more worried about getting spots for their subjects in the trial rather than not having enough patients to put in the trial. With regard to the eligibility, yes, we need to have evidence of illness so that we can identify whether there's benefit from the drug. So we're doing that. We're selecting patients that have obvious illness. And I think it'll be fine. I'm not worried about that.

Thank you.

The next question comes from Mari Raycroft with Jefferies. Please go ahead.

Hi, this is Amy. Congratulations on the quarter. Just a follow-up on a previous question. Can you provide more specifics to how you would provide updates and disclosure around the Nevada Band program? And can you talk about your strategy to potentially get FDA on accelerating the timelines? Thank you.

Sure. For November, as Bill mentioned, the enrollment is going well, and so we would probably update once we have the pivotal study fully enrolled. And then, so what was the second part?

The second part is about doing our best to pull that forward. Yeah. As this program matures, that's obviously something we'll be focused on. So, for example... elements of the BLA that we can start writing, we'll start to write. We won't have a crystal clear understanding of the timing of the BLA until two things happen and one is the last patient first visit so that we can predict when the last visit is for 12 months later obviously and the next is getting clarity with the division at a pre-BLA meeting on the total content of the BLA, and obviously that comes later. So I think we'll be able to provide more clarity in due course.

Thank you.

The next question comes from John Wollobin, Citizens. Please go ahead.

Hi, this is Catherine on for John. I just have a quick question about If you guys are seeing any impact from kind of the recent new entrants, including the oral acute therapies, are any patients like sort of switching to Orladeo? Are you seeing kind of differences in the reasons for patients switching? I know there's not really been much of an impact on revenues, but if you expect any impact or if you're starting to see it at all, any color on that? Thank you.

Sure, Catherine. You know, as we said earlier, particularly a lot last year leading up to new entrants coming in, we did not expect there to be an impact on Orlodeo from new prophy entrants because there's a real difference between patients who want oral prophy and then patients who are more comfortable with injectables. So we expected the injectables to be competing more with existing injectables And that's what we're seeing. So it's not changing oral adeo prescribing patterns or patient patterns in general. As far as oral on-demand oral acute therapy, that's something we're certainly not seeing it affect oral adeo negatively in any way. We think over time there is a potential for a tailwind of just patients who want to be in an all-oral combination, so one pill once a day to prevent attacks and then for the occasional breakthrough attacks, treat with another oral. That's a great opportunity for many patients. But it's too early to say whether that tailwind is going to occur.

Thank you so much.

The next question comes from Serge Belanger with Needed Men Company. Please go ahead.

Hi. Good morning. This is John. I'm for surge today. Thanks for taking our questions. First, just on Orlodeo, you know, you guys took a 9% price increase in January. Beyond that, you know, curious which levers you'll be looking at most closely in 26, whether it be, you know, maintaining trends of new patient ads or making slight improvements on paid prescription rates, either in Medicare or commercial channels. And then on the pellet formulation for pediatrics, curious how we should think about the pacing of patient identification and conversion throughout 26. And does your current guidance, you know, assume any material contribution from this segment this year?

Great. Thanks, Sean. Yeah, we did take up a 9% price increase in early January, which is higher than we've done in the past. half of that, so about 4.5%. And so that is something more because Orlodea was a lot lower priced than most of the other products in the market, and so this was just a little bit of a catch-up, but not something that we need that kind of pricing going forward to get to our long-term peak of $1 billion. For this year, the KPI that is most important to us is net patient growth. And as we've said, and it's in our slides today, what we need is 150 patients, net patient growth average per year for this year and three more years to hit a billion dollars in 2029. So we're very much within sight of getting to that billion dollars. And so that's the number one thing. Of course, we're always working to improve the paid rate incrementally. We made a big jump in that last year. And now it's just about making incremental improvements, and we're using our real-world evidence. So, for example, in patients with normal C1 inhibitor, we're starting to see more plans adopt favorable coverage policies for this based on the real-world evidence that we're providing. So that's a constant process. And then for the pellets, one of the things I mentioned in my remarks is HAE is underdiagnosed in kids. We've found about 500 patients in claims data for kids under age 12. But statistically, based on the epidemiology, there should be 1,200. And one of the reasons is parents are sometimes reluctant to get their kids tested because they're, frankly, hoping their kids don't have HAE. But the availability of an oral therapy, we think, and we've seen this in the early days of the HAE market, Having a therapy encourages diagnosis. So there's a market growth opportunity. And then kids are only treated with prophy at about a 40% rate, which is half that of adults. And so there's kind of a potential to up to double the number of kids diagnosed and up to double the treatment rate. And we think that an oral prophy is the thing to do that. And then as far as guidance, yeah, the PEDS launch is in our guidance for this year, but it's a really small part. We are very bullish long-term on what this indication is going to mean for kids and for revenue. But what we don't know is how quickly that transformation is going to happen. And so we've been conservative in our thinking for this year. And then we'll see how it goes. But, you know, if it goes faster than we expect, it could be a tailwind.

Great. Thanks for the call.

Again, if you have a question, please press star then one. Our next question comes from Stacy Koo with TD Cohen. Please go ahead.

Hi, team. This is Vish on for Stacy. Congratulations on a great year and really appreciate your comments on the competitive dynamics. Thanks for taking our questions. We have a couple. So, first, for Orla Day or expectations for Q1, can you give us an idea of how the reauthorization process is progressing this year? We know you had made some improvements in the process last year, which resulted in faster than expected reauthorizations. So just walk us through what you're seeing and what we and investors should expect for Q1. And then second and final for us, are you, you know, given the EU business sale, are you willing to split your 2026 guidance for us into US and ex-US contributions? How should we be thinking about that?

Great. Thanks, Fish. I'll take the first question and pass it over to Bob for the second question. Q1, every Q1 is the big reauthorization season. It's a ton of work. Our team prepares for it. They're right in the midst of that process, and our team's gotten really good at it. What you should expect for Q1, because this year we don't have any huge tailwind like we did last year with the Medicare patients and the Affordable Care Act, making, sorry, the IRA, making it more affordable for patients. The Medicare patients are in great shape, so we won't have that tailwind. So this year, you should expect revenue probably to be slightly down versus Q4 as we go through the re-off. We have to give away more free product. We have to pay a higher percentage of co-pays for the commercial patients, and so that drops revenue, even as our patient base continues to grow. So down a bit in Q1, and then it pops up again in Q2. And, Barbara, you want to just talk about the U.S. versus global?

With respect to your question on the costs and contributions from Europe, if you look at our press release in the financial tables, we actually attempted to break out all that European business. And I think, as we have previously stated, that European business while growing was also loss making. So you can actually see that our base business margins were incredibly strong compared to the, U.S. business margins are incredibly strong compared to Europe. So when you look at that profitability metric that I quoted, 214 million, that strips out all of Europe. And from the exhibits you can glean that the base business costs are $380 million roughly for U.S. in 2025. To give you a perspective what it looks like in 2026, and this goes back to the same cost discipline, We shut off Europe, but we added a very, very highly de-risked late-stage program in Navanabar. So our total costs are in the $450 to $470, of which the base business is actually not growing by much. The cost additions are primarily coming from adding Astria. So that's the discipline that I talked about, that we will continue to make sure that our base business costs remain low, and we continue to drive growth. Hope that answers your question.

Yeah, sorry. Thanks for the clarity, Babar. My question was relating to the 2026 guidance, the 625 to 645 million that we're expecting for this year. How should we think about the U.S. and ex-U.S. split there?

Yeah, so a majority of that is going to be from the U.S. We have retained some markets. And as you can see, you know, after Europe, the split usually is now it's a little bit over 90%. So while we're not breaking out, the majority of that is coming from the U.S. business.

Got it. Thank you very much.

This concludes our question and answer session. I would like to turn the conference back over to Charlie Dyer for any closing remarks.

Thanks very much. 2026, as we've been describing, is a really big year for Viacris. We've got continued Orlodeo patient growth. We're super excited about the launch of Orlodeo for kids. A lot of important clinical trial execution for Nevenabart and 17725 that's going well. And I'd really like to thank all the hardworking owners at Biochrist for what they did to make 2025 a great year and what they're doing this year to deliver another year of great results. So thanks, everyone. Have a great day.

The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.