On our handover to host, Meredith Kiernan, Head of Global Corporate Communications, to begin. Please go ahead, Meredith.
Thank you, Operator, and good morning, everyone. I'd like to welcome you to Mirum Pharmaceuticals' conference call. I'm joined today by our CEO, Chris Peetz, our President and COO, Peter Radovich, our Chief Medical Officer, Joanne Quan, and our CFO, Eric Bjerkholt. Earlier today, Mirum issued a news release announcing its proposed acquisition of Bluejay Therapeutics. The signing of the definitive agreement for this proposed transaction represents an important step in expanding Mirum's rare disease portfolio and advancing our late-stage pipeline. This news release can be found in the Investors section of our website. Speakers will be referencing a transaction announcement presentation that can be found in the Events section of our website.
Before we begin, I'd like to remind you that during the course of this conference call, we will be making certain forward-looking statements about Mirum and our programs, as well as the proposed acquisition of Bluejay and Bluejay's programs. These are based on management's current expectations, including statements regarding Mirum's business plan, development program, strategies, prospects, market opportunities, and financial forecasts and guidance, as well as Mirum's expectations with respect to the closing of the proposed acquisition and its expected benefits if completed. Mirum is under no duty to update these statements, and they are subject to numerous risks and uncertainties, and actual results could differ materially from the results anticipated by these statements. Investors should read the risk factors set forth in Mirum's latest 10-Q filing and any subsequent reports filed with the SEC.
I'd also like to remind you that the proposed transaction with Bluejay has not closed and remains subject to customary closing conditions. Prior to closing, Bluejay remains a separate company from Mirum, and both Mirum and Bluejay will continue to operate independently until after closing. With that, I'll now turn the call over to Chris. Chris?
Thanks, Meredith, and good morning, everyone. Today marks another exciting milestone for Mirum, building on a year of strong commercial and pipeline momentum. I'm happy to announce that Mirum has entered into a definitive agreement to acquire Bluejay Therapeutics, which will add brelovitug, an anti-hepatitis B surface antigen monoclonal antibody being developed for chronic hepatitis delta virus, to our pipeline. This transaction will deepen our position as a leading rare disease company, purpose-built to bring forward breakthrough medicines for patients with overlooked conditions. Hepatitis delta is a severe, rapidly progressive rare disease with high unmet need and no approved treatments by FDA. Brelovitug has compelling phase II results and has the potential to become a foundational therapy in this setting. This proposed acquisition is highly anticipated, pardon me, this proposed acquisition is anticipated to be highly aligned with our core strategy and capabilities.
First, we're following clear clinical data showing brelovitug has the potential to change the standard of care for patients. The recently announced results Joanne will highlight are outstanding and earned the program Breakthrough Therapy and PRIME designations in this severe, significantly underserved disease. Second, hepatitis delta represents a highly synergistic fit for Mirum. It would be a natural extension of our rare disease expertise, and we look forward to continuing to develop and potentially commercialize another Breakthrough Therapy following the closing. Third, brelovitug's ongoing phase III program will meaningfully expand our late-stage pipeline and will add a fourth potential registrational readout in the next 18 months, with a potential BLA submission in the first half of 2027. Finally, the closing of this proposed transaction would build value within Mirum while maintaining our financial independence.
With a solid balance sheet, the proceeds from the concurrent financing announced this morning, and our growing commercial business, we are well positioned to support brelovitug through registration and launch. Overall, this addition to the pipeline following the closing will bring the revenue potential of our rare disease portfolio to over $4 billion. What the Bluejay team has created is impressive and critically important to patients, and we look forward to welcoming this high-performing team to Mirum following close. And with that, I'll hand it over to Joanne to walk through the clinical program and upcoming milestones. Joanne?
Thanks, Chris. We see strong promise in brelovitug for patients with hepatitis delta, a population with a severe burden of disease and few therapeutic options. To start, I'd like to provide a bit of background on delta. Delta is the most severe form of viral hepatitis and only occurs in the setting of co-infection with hepatitis B. Patients with delta have a risk of hepatocellular carcinoma three times that of HBV alone, and nearly half progress to liver-related death within 10 years of diagnosis. The delta virus hijacks the hepatitis B surface antigen for its own viral envelope. Thus, targeting hepatitis B surface antigen is a compelling treatment approach for delta. Brelovitug is a fully humanized IgG1 monoclonal antibody that binds to hepatitis B surface antigen, thereby rapidly clearing virions and subviral particles and preventing infection and replication.
The results of the brelovitug phase II study presented at a recent AASLD plenary session, highlighted on page seven of the presentation, show the potential for this treatment to substantially decrease viral load and improve liver function. The phase II study in 47 adults with chronic hepatitis delta demonstrated 100% virologic response, defined as a two log or greater reduction or target not detected for HDV RNA. This was observed across all dose groups at 48 weeks, with nearly all patients achieving this response by 24 weeks. Importantly, 65%-82% of subjects achieved the composite endpoint of virologic response and ALT normalization, which is highly encouraging given the progressive nature of this disease. The safety profile was favorable, with no Grade 3 or higher adverse events, no serious adverse events, a low rate of flu-like symptoms, and no ALT elevations or neutropenia.
Based on this data, brelovitug has been granted FDA Breakthrough Therapy designation and PRIME designation in the EU. Brelovitug is currently being evaluated in the AZURE phase III program, which is well underway. The AZURE program is designed to meet registration requirements in both the U.S. and EU, using clear objective endpoints aligned with FDA and EMA. An overview can be found on slide eight of the presentation. Both FDA and EMA agree that meeting the combined endpoint of virologic response and ALT normalization in phase III will support registration. As noted above, virologic response is defined as a two log or greater decline or target not detected for HDV RNA. Registration in the U.S. will be supported by the AZURE-1 and AZURE-4 studies, with a primary composite endpoint of virologic response and ALT normalization.
Each study is evaluating two doses of brelovitug, a once-weekly 300 mg Sub-Q dose and a once-monthly 900 mg Sub-Q dose. Each study also includes an extension period to support long-term safety and efficacy. The AZURE-1 study will include 150 patients, randomized two to two to one, treated at open label in two dose arms of brelovitug versus delayed treatment for 24 weeks. There will be an interim analysis when the first 50 patients reach 24 weeks of treatment, and we expect this interim data will be available in the second quarter of 2026. The AZURE-4 study is similar in design to AZURE-1 and will include approximately 80 patients, randomized two to one to one, with a treatment delay of 12 weeks. Both studies are enrolling well, and final data for both are expected in the second half of 2026 to support a BLA submission.
AZURE-2 and AZURE-3 will compare brelovitug to an active control, bulevirtide, which is approved in the EU. AZURE-2 and AZURE-3 are 48-week and 24-week studies, respectively. These studies are intended to support EMA registration as well as long-term safety and efficacy, with final data expected by the first half of 2028. Altogether, the clinical data, regulatory alignment, and program momentum give a strong conviction in phase III AZURE program's ability to advance brelovitug toward registration. We're very impressed by what the Bluejay team has been able to accomplish in such a short time and are excited to welcome them to the Mirum team to advance the hepatitis delta program efficiently toward regulatory submissions. We see brelovitug as an important medicine to fill a critical treatment gap for delta, and we're excited to help bring it to patients.
With that, I'll hand it over to Peter to provide more color on our commercial approach to hepatitis delta and how brelovitug fits our broader strategy in rare diseases. Peter?
Thanks, Joanne. Hepatitis delta is a natural extension of our rare disease commercialization strategy. Bringing life-changing medicines to underserved and underdiagnosed patients is where Mirum excels, and brelovitug squarely fits this profile, adding to our portfolio another high-impact rare liver disease medicine with significant leverage on Mirum's existing commercialization capabilities. Hepatitis delta is a rare disease with substantial morbidity and mortality but limited treatment options. While there are an estimated 40,000 prevalent delta patients in the United States and over 230,000 in the U.S. and EU combined, most go undiagnosed. For example, in the U.S., we believe there are about 15,000 delta patients who are currently diagnosed, insured, and under care. This estimate is based on claimed data of hepatitis delta patients with multiple interactions in the healthcare system, which we see as a solid starting point for an initial U.S. launch population.
The rate of diagnosis is higher in Europe due to the availability of an approved treatment and the growing implementation of EASL-recommended delta reflex testing hepatitis B patients. And even with the low rate of diagnosis today, we see substantial revenue potential for brelovitug in delta. In our view, the rarity of the population and the severity of the disease, coupled with brelovitug's expected compelling clinical profile, supports a global revenue potential of at least $750 million. Operationally, we are in an excellent position to support the commercialization of brelovitug. Our global commercial operations are already in place, delivering $500 million-$510 million in expected 2025 worldwide sales, and a brelovitug launch would heavily leverage our existing organization that commercializes LIVMARLI and the bile acid portfolio, as well as our ongoing expansion for volixibat's expected 2027 launch in PSC.
While we expect to make modest incremental adds to our field teams to cover areas like infectious disease and selected internal medicine practices where delta patients are managed, we see launching brelovitug as highly leveraging our existing team, operations, expertise, and relationships. In the U.S., for example, hepatitis delta is geographically concentrated, with the majority of currently diagnosed patients located in seven states and primarily managed in urban centers. In important global markets for delta, our global commercial infrastructure is in place with deep and proven stakeholder relationships that we expect to leverage to drive broader geographic access for brelovitug. Overall, we are excited about the impact brelovitug is expected to have for hepatitis delta patient community, and we are energized by the opportunity to deliver another high-impact medicine to a population in urgent need with limited treatment options.
Together with LIVMARLI, CTEXLI, CHOLBAM, and volixibat, brelovitug will strengthen our rare disease portfolio and extend the impact we can have across rare disease patient communities, and with that, I'll turn it over to Eric to walk through the transaction terms and financial impact. Eric.
Thanks, Peter. Under the terms of the agreement, Mirum will acquire Bluejay for $250 million in cash and $370 million in Mirum stock, priced at $71.21 per share, with up to $200 million in tiered sales-based milestone payments starting at $500 million in annual sales. In addition, we've secured $200 million through a private placement financing from a syndicate of leading healthcare investors, which will fund concurrently with the closing of the proposed acquisition. We expect the transaction to close in the first quarter of 2026, subject to regulatory approval and customary closing conditions. Operationally, we are well positioned to absorb the HDV program. There is no change to our 2025 guidance, and with our growing commercial business, we expect to return to be cash flow positive in 2027.
We expect that the incremental expenses associated with the brelovitug program will support the ongoing execution of AZURE phase III program and manufacturing validation and scale-up in preparation of the anticipated BLA submission in the first half of 2027 and subsequent commercial launch. As Peter mentioned, we anticipate significant synergies with our existing commercial efforts and would only expect a modest increase to our ongoing efforts supporting LIVMARLI and volixibat. In summary, this transaction is consistent with our disciplined approach to capital allocation and business development. Without compromising our financial independence, we have expanded our rare disease portfolio with a high-value, late-stage medicine that features compelling data, a clear regulatory path, and significant value potential. With that, I'll turn the call back to Chris for closing remarks.
Thanks, Eric. I'd like to again express how excited we are to welcome the Bluejay team and the hepatitis delta program to Mirum following closing. We have created a potentially paradigm-changing medicine for delta, and I look forward to what we together will accomplish at Mirum. This proposed acquisition aligns with our vision as a leading rare disease company with a portfolio of transformative programs and will add meaningful strategic and financial value. Our commercial business is strong and growing. We are entering a phase of accelerating value creation potential with four registrational stage readouts in the next 18 months. Next up will be volixibat VISTAS PSC top-line data in Q2, with the potential to bring the first approved therapy forward for PSC patients.
This will now be followed by the brelovitug AZURE-1 and AZURE-4 results in the second half of 2026 before the LIVMARLI EXPAND and volixibat PBC data expected in the first half of 2027. It is an important catalyst calendar for both bringing forward new medicines for patients and to shape the next chapter of Mirum. With that, Operator, please open the call for questions.
Thank you very much. To answer your question, please press star followed by one on your telephone keypad now. If you change your mind, please press star followed by two. When preparing to ask your question, please ensure your device is unmuted locally. Our first question comes from Mani Foroohar from Leerink Partners. Your line is open, Mani. Please go ahead.
Hey, guys. Thanks very much for taking the question. Congrats on what looks to be another deal at a pretty attractive peak sales multiple. Can we talk a little bit about how you see the competitive dynamics? I know Hepcludex is not approved in the U.S., but we filed. How do you see our competitive dynamics and positioning? And then one pushback we've gotten from Baird is, well, could that being approved in the U.S. change some of the nuances of your registrational path forward or regulatory treatment? If you could address those two, that'd be really helpful.
Hey, Mani. Thanks for the question. I'll touch on the last part briefly and then pass it over to Peter to talk about the commercial dynamics. In terms of the registrational path and Hepcludex being potentially submitted, there's really clear buy-in from FDA on this program. So comfortable that AZURE-1 and AZURE-4 are designed and set up to support registration in the U.S.. Kind of as you mentioned, there is a head-to-head component in the European studies, AZURE-2 and AZURE-3, but FDA has given clear feedback and buy-in on that AZURE-1 and AZURE-4 supporting filing in the U.S.. But I'll let Peter kind of talk about how we see this playing out commercially once we get to a potential approval.
Yeah. Thanks, Mani. I mean, I think with regards to Hepcludex and Gilead entering the U.S., we see this as a real positive to develop the market.
As we mentioned in our prepared remarks, we've seen what's happened in Europe over the last five years with the availability of an approved product and EASL and changing their guidelines to do reflex testing. You could imagine possible similar dynamics may occur in the U.S., and with that product being approved more and more, patients being diagnosed and the market being developed. Obviously, we're really excited about the monoclonal antibody approach targeting the surface antigen, HBsAg, and I think that's kind of an approach that's distinguished itself as highly active in terms of the delta emerging treatment landscape. What we really like about the Bluejay program is the single drug, 100% virologic response rate, really compelling ALT normalization rates, and a great safety profile so far, very low rates of flu-like symptoms. So feel really good about the profile here.
Thanks, guys. And if I can slip in one commercial follow-up. When we think about the adult side of the rare liver disease franchise, can you give us a sense of how to think about the evolution of operating margins going forward? You should get some operating leverage from these combinations of agents together in the same bag, but that mostly depends on how tightly defined and similar the call points are. So can you just give us a sense of how to think about that?
Yeah. I mean, I think we expect the commercial operating margins to continue to improve. As you know, we're planning an expansion with the PSC launch in 2027. That'll get us a little bit deeper outside of the tertiary kind of academic medical centers where LIVMARLI is prescribed today. With delta, actually, the top KOLs for delta, many of them are already prescribing LIVMARLI today. Many of the delta patients are taken care of out in the community and private practice GI settings. Those are a lot of the same docs that take care of PSC patients and even some LIVMARLI and CTEXLI patients. And then we just have an incremental expansion on top of that into infectious disease, selected internal medicine. So overall, the high-level kind of story is continued margin expansion on the commercial side.
Thanks, guys. I know I stuck an extra one in there. Congrats again.
Thanks for the questions.
Our next question comes from Josh Schimmer from Cantor. Your line is open, Josh. Please go ahead.
Great. Thanks very much, and congrats on the transaction. I believe there were royalties and some economics owed from Bluejay to Novartis. Can you summarize those? And then can you discuss your plans for potential international commercialization of the product? Thanks.
Yeah. Thanks for the question, Josh. On the Novartis kind of background license, pretty favorable terms there. So low single-digit royalty and some fairly minimal milestones back to Novartis. So attractive helps us continue to improve margin over time. And I'll turn it back over to Peter to comment on kind of international commercial opportunity.
Yeah. As Joanne highlighted, phase III AZURE program is very well designed to support international commercialization, a direct comparison to brelovitug, which would be quite helpful for international markets. We have a team at Mirum that directly commercializes LIVMARLI in several Western and Central European countries, U.S., Canada, distributor network that extends well beyond those countries, well north of 30 countries around the world with reimbursed access to LIVMARLI.
So we plan to heavily leverage that group of people with kind of modest expansions to the on-the-ground footprint that we mentioned before to launch this product.
Great. Thanks very much.
Thanks for the question.
Our next question comes from Brian Skorney from Baird. Your line is open, Brian. Please go ahead.
Hey, guys. Thanks for taking the question. This is Charlie on for Brian. So really impressive results. Do you guys think at all, just based on the competitive space, it's necessary to pair with an siRNA for any additional efficacy? And what are you thinking about in terms of the rest of Bluejay's pipeline going forward? Are you interested in pursuing the HBV functional cure pathway, or is this more so wholly focused on HDV? Thank you.
Thanks for the questions, Charlie. On the second part of your question first, we're very much focused on the delta program. That's where the data is clear that this is tracking towards being a standard of care medicine, so we don't plan to invest in the HBV pipeline agents that Bluejay has. This is all about bringing focus to that brelovitug for delta. And that kind of then leads into the answer to the first part of the question where the results that we see from the phase II proof of concept already are hitting 100% virologic response, really high results on the FDA composite endpoint, so frankly, not sure that an additional agent is needed. You're driving really fantastic results with a single agent, so excited about the profile of how convenient this can be as a therapy to get really competitive response rates for patients.
Great. Thanks for the answer.
Thanks for the questions.
Our next question comes from Gavin Clark-Gartner from Evercore ISI. Your line is open, Gavin. Please go ahead.
Hey, this is Yashan for Gavin. Congrats on the acquisition. Just a quick question from us. For the at least $750 million worldwide peak sales number that you noted, how much of that do you envision coming from the U.S.? And then what would that correspond to for the number of peak U.S. patients treated? And then how does that kind of compare to what you found in the healthcare system from your commercial intelligence? Thank you.
Yeah. Thanks for the question. So yeah, we would anticipate the majority of the peak sales would come from the U.S., kind of on the order of 2/3 or so. And yeah, the question with regards to patient numbers, it does kind of assume roughly on the order of 2,000 to 3,000 patients at peak treated chronically. That's kind of in comparison to the 15,000 patients who are kind of diagnosed and under care and insured today. So we think pretty reasonable base case way of thinking about the product.
Thank you so much.
Thanks for the question.
Our next question comes from Michael Ulz from Morgan Stanley. Your line is open, Mike.
Good morning. Thanks for taking the question and congratulations.
Good morning. Thanks for taking the question and congratulations on the deal as well. Maybe just to follow up on an earlier question I think was asking about a competitor out there that's also in phase III, if you can maybe talk about some key points of differentiation for your program versus theirs? Thanks.
Thanks, Mike, for the question. I think probably referring to the program of tobevibart and elebsiran, which also had phase II results at AASLD, really, again, a very active regimen and has the overlap of mechanism with the hepatitis B surface antigen targeted antibody. So do expect to have another regimen that eventually gets approved for this setting coming out of that program. We're really excited about brelovitug and its profile, namely what we see on the FDA composite endpoint, the 65%-82% response rate for virologic response with ALT normalization. That is among the most highest response rate on that endpoint that's been presented. So excited about what that means for the approval path and competitive positioning. And then having just the single agent antibody and how clean that is from a tolerability and safety profile, we do see that as an advantage taking brelovitug to launch.
So really what drove us to enter this agreement is that compelling data coming out of a single agent regimen.
Great. Thanks, and congrats again.
Yeah. Thanks for the question.
Our next question comes from Ryan Deschner from Raymond James. Your line is open, Ryan. Please go ahead.
Good morning and congratulations on the new pipeline expansion. A couple of questions. Curious if you could talk a little bit about the IP portfolio associated with brelovitug when you expect LOE, and was this a competitive deal process? Thanks.
Thanks for the question, Ryan. Yeah. On IP, there's composition of matter to 2041, which would be eligible for some potential extension beyond that. So great duration of exclusivity expected for the program. And would you remind me of the second part of your question?
Was this a competitive deal process?
Oh, yeah. On talking a little bit of background on the transaction, to kind of answer that, where we do think that there was other interest in the program overall, but this is something that we've followed for well over a year. We identified this as a really interesting program from some of the early results presented even last year, and so this is the result of a long ongoing conversation, getting to know the program and the Bluejay team. I'm excited that we were able to get to something that works for both parties and adds a lot of value to Mirum.
Fantastic. Thank you very much. Congrats again.
Thanks for the question.
Our next question comes from James Condulis from Stifel. Your line is open, James. Please go ahead.
Hey, thanks for taking my question and congrats on the acquisition. Can you maybe just talk about this interim in Q2 a little bit and in terms of kind of what are the outcome scenarios and how important is it, and looking ahead for kind of the full studies, could you also just talk about powering and if you need both studies for approval, any color of that would be great. Thanks.
Yeah, James, thanks for the question. Just one quick comment, and I'll pass it over to Joanne to go into a little bit more of the detail. Just to clarify, the FDA package is AZURE-1 and AZURE-4. So both of those studies are tracking towards top-line data in the second half of 2026. So clear buy-in that both of those studies are the two phase IIIs to support a U.S. approval. I'll have Joanne give a little bit of color on the interim and how the results play out.
Yeah. Thanks, James, for the question. The interim is set up so that we get a readout when 50 patients in the AZURE-1 study reach 24 weeks, and that will be in Q2. We expect, given the strong results that we're seeing in the phase II with the fairly limited number of patients there, that this will be, again, a strong result. The overall powering for the studies is really not for efficacy, given a highly effective agent, but it's really to have enough patients for the safety database. And that's really what drives the numbers for both AZURE-1 and AZURE-4, specifically for FDA. As you know, with a highly effective agent, you're often not powering for efficacy. You're really overpowered for that. And then you're really looking at the numbers of patients to be treated to meet requirements for safety database and characterization there.
And that's exactly the situation we have here. So even with a strong interim result, then the studies would not stop early simply because we need to collect additional data to support the safety database.
Makes sense. Thank you.
Thanks for the questions.
Our next question comes from Joseph Thome from TD Cowen. Your line is open, Joseph. Please go ahead.
Hi there. Hi there. Good morning. Thank you for taking my questions and congrats on the announcement. Maybe one just on the overall addressable population. I guess what are sort of the main blocks right now to kind of increase that addressable market in the U.S.? Is it that patients aren't being seen by their physicians or they're not being screened for delta? And maybe what can you do over the next couple of years before the drug is available to maybe increase that? And then maybe just one point of clarification on the supportive AZURE-3 and AZURE-2 studies for Europe. Are these superiority studies or are these non-superiority studies? Just kind of any color on that would be helpful. Thank you.
Great. Yeah. Thanks, Joe. With regards to addressable population in the U.S., the 15,000, yeah, that is the number of patients in the U.S. who are diagnosed, insured, kind of under management, interacting frequently with the healthcare system today. Yeah, I think that in terms of how to increase that and get it something closer to the prevalent population, which we and others estimated about 40,000, I think the biggest lever you have there is to do reflex testing like they've implemented in Europe. If AASLD or others were to endorse that and physicians were to adopt that and do delta reflex testing and hepatitis B surface antigen positive patients, I think you'd most likely see the diagnosis rate go up, much like the Europeans have published. And then maybe I'll pass to Joanne to comment on the design for AZURE-2 and AZURE-3.
Yeah. So AZURE-2 and AZURE-3 are both superiority studies. One of them is a switch study. So patients already taking bulevirtide for at least six months will either continue bulevirtide or switch to the brelovitug antibody. And the other one is a head-to-head in patients who have not been previously treated with either agent, too, brelovitug versus bulevirtide. So given the strong data that we saw with the high 100% virologic response rate and then also the high rates of reaching the combined endpoint, we feel pretty confident in terms of both of these studies having a positive outcome.
Great. Thank you very much.
Thanks for the questions.
Our next question comes from Jon Wolleben from Citizens. Your line is open, Jon. Please go ahead.
Hi, this is Catherine on for Jon. Just have a quick question about the weekly versus monthly dosing regimens. In particular, how are you looking at the phase III hierarchy and any differential responses you guys are expecting? And then how important is it to have both for a commercial launch? Thank you.
Maybe just to comment on the last part and then pass it over to Joanne. The data will speak for which regimens actually get submitted for approval. But either one of these would be a convenient option for patients. So you're comfortable with either one of them having a really compelling profile.
Yeah. So when we look at the PK from either of these doses from the phase II study, they actually are fairly similar in terms of overall exposure. So there's probably a fair amount of overlap in terms of the actual antibody exposure to the patient with either of these regimens. The weekly Sub-Q can easily be given at home. Currently, the monthly dosing regimen is actually given in the clinic. So both of these have been taken forward. But on balance, they're probably more similar than they are different, if that makes sense.
Great. Thank you so much.
Thanks for the question.
Our next question comes from Swayampakula Ramakanth from H.C. Wainwright. Your line is open. Please go ahead.
Thank you. This is RK from H.C. Wainwright. Congratulations on this acquisition. And I have a couple of quick questions. One of them is, obviously, the investment thesis here is heavily relying on the success of the phase III asset. So what sort of data gives you confidence for not only the clinical profile, but also the probability of success here? And then beyond the clinical program itself, what other execution risks are you kind of looking at to mitigate, especially things like manufacturing or competition or commercial readiness itself?
Thanks, RK, for the question. I mean, overall, just kind of recap some of the points made from the clinical data that gives us confidence here is the phase II results that Joanne went through are just really impressive. You're seeing 100% virologic response and 65%-82% on the FDA composite endpoint. So we feel really good about those phase II results and what that means for the probability of the phase III program reading through. And also just what that means for patients to have a treatment option that's driving virologic response in 100% of patients, obviously, would be a game changer for the setting. And in terms of overall, the risks going forward, I mean, that's a great question. We can speak a little bit to some of the diligence work that we did.
Really have to say that the Bluejay team has done a fantastic job setting up this program for success. Continuity of that team working on this program, given they have such momentum in the phase III execution, that's one of the things we're focused on, on bringing that team over to help us continue to drive the program forward. On the manufacturing side, everything's lined up. A lot of good planning and investment that's gone in on that front. We feel great about the status of the program and driving to that phase III readout in the second half of next year.
Thank you. If I may, another question, just on the strategy itself. So once you have this program onboarded, how does this, in the long term, change your competitiveness within the rare liver disease landscape?
Yeah. We see this as just a way to, I'd say, just double down on everything else that we're doing in the space. We already have strong relationships with all the key stakeholders here, and we're bringing really important medicines forward for them to treat their patients. So it only deepens that relationship and offering that we have over time.
Thanks. Thanks for taking my questions.
Thanks for the questions.
We currently have no further questions. So I'd like to hand back to Chris with some closing remarks.
Great. Well, thank you all for joining the call this morning. We look forward to providing updates throughout a busy 2026 ahead. Have a great day.
That concludes today's call. We thank everyone for joining. You may now disconnect your lines.