Good morning, and welcome to the Albireo Pharma Business Update Call. At this time, all participants are in a listen-only mode. A question and answer session will follow the formal presentation. If anyone should require operator assistance during the call, please press star zero on your telephone keypad. Please note that this conference is being recorded. I will now turn the call over to your host, Hans Vitzthum, Managing Director of LifeSci Advisors. Thank you. You may begin. Thank you, operator. This morning, Albireo issued a press release highlighting top-line results for the ASSERT phase III pivotal trial evaluating Bylvay in Alagille syndrome. This press release is accessible via the company's website at albireopharma.com. Before proceeding, we would like to note that management's comments today may include forward-looking statements regarding the company's plans and expectations. These statements are being made under the Private Securities Litigation Reform Act of 1995, and they are subject to various risks and uncertainties. Actual results may differ materially due to various important factors, including those described in the Risk Factors section of our most recent Form 10-K and our subsequent SEC filings. These filings can be accessed from the investor section of the website at albireopharma.com or on the SEC's website. Any forward-looking statements represent our views as of today, October 11, 2022, and should not be relied upon as representing our views as of any subsequent dates. We undertake no obligation to update these statements publicly. Now it is my pleasure to turn the call over to Ron Cooper, Albireo Pharma's President and Chief Executive Officer. Ron? Well, thank you, Hans, and thank you all for joining us this morning. With me today are Dr. Jan Mattsson, Chief Scientific Officer and Head of R&D. Pamela Stephenson, our Chief Commercial Officer, and Simon Harford, our Chief Financial Officer. Dr. Nadia Ovchinsky, pediatric gastroenterologist and hepatologist at the Children's Hospital at Montefiore, ASSERT principal investigator. It's a privilege to have her join us to provide her clinical perspective on the news. We are pleased to announce a positive outcome for our ASSERT trial, the first and only gold standard phase three placebo-controlled trial in Alagille syndrome. Bylvay, the most potent non-systemic IBAT inhibitor, achieved a significant reduction in the primary pruritus endpoint measured by scratching with a highly statistically significant triple-digit P value of 0.002. We're proud to deliver these positive phase three results to the Alagille community. Before we get into the details, I'd like to begin by thanking the investigators, patients, families. Without the community cheering us on, we could not deliver this result. We plan to immediately submit regulatory filings to the FDA and EMA. For our first indication with Bylvay and PFIC, we established a new industry benchmark by completing regulatory submissions in less than 70 days following our top-line data announcement, and we expect the same for this filing. Given that this will be a supplementary filing in both the U.S and EU, and with Orphan Drug Designation, we expect a rapid review and approval and look forward to providing the Alagille community a new treatment option in 2023. We will take you through the top-line results in the presentation we posted on our website following this call. ASSERT is the second successful phase III study conducted with Bylvay in rare pediatric cholestatic disease. The very first phase III study ever conducted in pediatric cholestatic disease with an IBAT inhibitor was the PFIC study in Progressive Familial Intrahepatic Cholestasis, or PFIC. In that study, Bylvay achieved both the pruritus and bile acid endpoints with triple-digit P values. Since then, Albireo has launched Bylvay in both the U.S. and Europe, generated many prescriptions and meaningful sales. However, PFIC represents the smallest commercial opportunity, with approximately 15,000 patients in the top global markets. A positive outcome for ASSERT in Alagille syndrome increases the potential patients we can impact by Bylvay by 25,000 to an approximate total of 40,000 between the two indications. We have a third phase 3 study in biliary atresia called BOLD, where we expect full enrollment imminently. Now that we're two for two in phase III trials with Bylvay in pediatric cholestasis, our confidence continues to grow for a positive outcome in BOLD. Biliary atresia is the largest market opportunity. With indications in PFIC, Alagille, and biliary atresia, we should be able to access approximately 95,000 global patients. Now to take you through the ASSERT data, I'll turn it to Dr. Jan Mattsson, our Chief Scientific Officer, head of R&D, and founder of the company, to go through the study design and the top-line results. Jan? Thank you, Ron. We are pleased with the positive results we observed in the ASSERT study. Let me first begin by providing a little background on Alagille syndrome. Alagille syndrome is a very complicated and heterogeneous disease. Which makes it difficult to design clinical trials. It's a rare, life-threatening, complex genetic disorder with multi-system involvement, including fewer liver bile ducts, leading to buildup of toxic bile acid levels causing liver damage. Almost 90% of patients are presenting with severe unremitting pruritus that can cause quality of life impairments, including sleep disturbances and growth issues or the failure to thrive. The literature shows that only 24%-40% of Alagille cholestatic patients reach adulthood with their native liver. I'd like to emphasize the rigorous design of the phase 3 ASSERT study, which is a double-blind, randomized, placebo-controlled trial designed to evaluate the safety and efficacy of 120 micrograms per kilogram per day Bylvay for 24 weeks. Key inclusion criteria were patients of any age with genetically confirmed diagnosis of Alagille syndrome, history of significant pruritus, and elevated serum bile acid levels. The study enrolled 52 patients randomized two to one to receive Bylvay or placebo. The primary efficacy endpoint measures pruritus by looking at a change from baseline in scratching measured by the PRUCISION Observer-Reported Outcome scratching score caregiver instrument, which is a zero to four point scale at month six or weeks 21 - 24. Key secondary efficacy endpoint is a change in serum bile acid responses from baseline to the average of week 20 to week 24. Additional secondary endpoints include evaluation of sleep, safety, and tolerability. There were no major differences between the placebo and Bylvay arms regarding patients' demographics or baseline characteristics. The patients had highly elevated serum bile acid levels and pruritus, despite that nearly all patients taking concomitant antipruritus medications, including ursodeoxycholic acid, which is commonly referred to as UDCA. In the primary analysis, the study met the primary endpoint showing highly statistically significant reduction in pruritus compared to the placebo arm with a P value of 0.002. As shown on the left graph of the slide, the patients treated with Bylvay had a mean reduction in pruritus of -1.69, which is a highly clinically meaningful reduction. The study also met the key secondary endpoint, showing a significant change in serum bile acid concentration from baseline to the average of weeks 20 and 24 compared to placebo with a P value of 0.001. As shown on the graph on the right side of the slide, patients treated with Bylvay had a reduction of serum bile acid from baseline of 90 micromoles per liter, whereas the level of bile acid in placebo-treated patients increased. In Alagille syndrome, pruritus, in addition to having a severe impact on quality of life, is a major driver of liver transplants, and bile acids are causing liver damage. Given our profound effect on both pruritus and bile acid levels, we would expect to see an increase in native liver survival in Bylvay-treated patients based on current data. Treatment with Bylvay led to early, rapid, and sustained highly statistically significant improvement in pruritus compared to placebo at each and every time point throughout the 6-month treatment. As early as 1-4 weeks, there was a significant reduction of pruritus in patients treated with Bylvay compared to placebo. Consistent with what we saw with PEDFIC, patients who received Bylvay experienced an improvement in sleep-related parameters observed as early as weeks 1-4 compared to patients on placebo. Sleep results will be important as we know that quality of life measures directly correlated to caregiver and family disease burden. On slide 11, you can see the data for one of the measured sleep parameters, days sleeping with a caregiver, which is an important measure of sleep for children and families. The data shows statistically significant improvements compared to placebo by week 1-4, with the improvements sustained through 24 weeks. In addition to days sleeping with a caregiver, Bylvay had a statistically significant impact on multiple sleep parameters, including days with help falling asleep with a P value of 0.003, days with soothing with a P value of 0.0001, and tiredness with a P value of 0.012. This data is important because sleep deprivation and disruption can have a profound impact on caregivers' and patients' quality of life. Bylvay was well-tolerated, and we were very pleased to have no discontinuations given the significant heterogeneity and severity of Alagille patients. There was a similar rate of treatment emergent adverse events in the placebo and treated group. The majority, though, were mild to moderate, and most events were assessed as unrelated to treatment. The drug-related treatment emergent adverse events, which occurred in 18% of the placebo group and 23% of the Bylvay group. The most common event was relatively low rate of diarrhea, which occurred in 11% of Bylvay-treated patients and 6% in placebo patients. Two placebo and five Bylvay-treated patients experienced serious adverse events, only one of which was deemed to be possibly drug-related. All events have been recovered or resolved by study end, and all patients completed the study. To summarize, ASSERT is the first, only, and largest phase III gold standard prospective intervention trial conducted for patients with Alagille syndrome. The diverse study population included patients from birth through early adulthood with both JAG1 and NOTCH2 mutations. The study achieved highly statistically significant improvements in pruritus assessment with a P value of 0.002. Highly statistically significant reduction in serum bile acids with a P value of 0.001. Substantial improvements in multiple sleep parameters, excellent tolerability profile and low rate of diarrhea and no discontinuations. All with early sustained efficacy with a once daily dose taken by capsule or sprinkle over food. With this positive data, we plan to file immediately with regulatory authorities in the U.S. and E.U., and intend to present additional data from the ASSERT study and open label extension study at upcoming scientific congresses. I'm delighted to have generated a highly positive outcome in the ASSERT study. I have been involved in many clinical trials over my years in the industry. These trials are not possible without the excellent collaboration between investigators, patients, and families. Before turning it back over to Ron, I too would like to express my thanks to them. Ron? Thank you, Jan. It's really my pleasure to introduce Dr. Nadia Ovchinsky, the principal investigator for the ASSERT trial. Dr. Ovchinsky is a pediatric gastroenterologist and hepatologist at the Children's Hospital at Montefiore. She received her M.D. and M.B.A. in Healthcare Management from Rutgers Robert Wood Johnson Medical School, and completed her pediatric residency, pediatric gastroenterology fellowship, as well as advanced training in pediatric transplant hepatology at Columbia University Morgan Stanley Children's Hospital of NewYork-Presbyterian. Dr. Ovchinsky's clinical and research interests involve improving quality, enhancing the delivery of care for children with chronic liver disease, optimizing outcomes of pediatric liver transplantation, and advancing therapies for children with cholestatic liver disorders. Before turning the call to Dr. Ovchinsky, on behalf of Albireo, I would like to express our appreciation for your collaboration and leadership in this important study. Dr. Ovchinsky. Thank you, Ron. I appreciate the opportunity to share my medical perspective on what these data mean for treating clinicians like myself and for future cholestasis treatment protocols. As Dr. Mattsson touched on, Alagille syndrome is a rare, life-threatening genetic disorder fitting a disease category with a great unmet treatment needs, particularly since it is a very heterogeneous patient population. The disease affects multiple organs, and each child's experience with the disease is uniquely different. I'm encouraged by the ASSERT data, as it is a significant advance to have a phase III double-blind randomized placebo-controlled trial with a substantial number of patients with very clear, highly statistically significant results. Based on the top-line data analysis, the key takeaway demonstrates that odevixibat has a meaningful impact on pruritus and on serum bile acid levels. I'm also thrilled with the impact on multiple sleep parameters. The improvement in pruritus and sleep helps improve the quality of life for these children and families, but the reduction in bile acids could have an important long-term impact on liver health. With my own experience in clinic with Bylvay, I'm very optimistic for families that can have a viable non-surgical option that could change the treatment landscape, especially with this child-friendly drug administration in capsules that can be taken with meals. I really want to take this opportunity to express my appreciation for my fellow investigators and most importantly, patients and families who participated in this trial. Without their participation and commitment to take part in the phase 3 study, we would not have the opportunity to have these positive results presented today and the potential for drug approval in the coming months. Ron, back to you. Great. Thank you, Dr. Ovchinsky and Jan for taking us through the data and providing insight on the impact for clinicians and patients. Now, you all may be wondering how this new data compares to the IBAT inhibitor body of evidence that has been generated to date. ASSERT and PEDFIC are the only two successful IBAT inhibitor phase III studies in pediatric cholestatic liver disease. If we look at the phase II data generated on Bylvay, the ASSERT bile acid and pruritus reduction levels as well as the diarrhea rate were similar. If we now look at the phase II data for the IBAT inhibitor that is already available in the U.S., it's difficult to compare because of the study designs. With that IBAT inhibitor, there were two phase II placebo-controlled studies, one of which had a pruritus primary endpoint and another a serum bile acid primary endpoint. In both studies, the primary endpoint was missed. It was not statistically significant. There was a third phase II study where all patients received drug and then a subset was withdrawn from therapy for four weeks. While the study met the primary endpoint, it is difficult to compare with ASSERT given the unique study design. If I were to characterize the ASSERT top-line findings, they are the clearest and most unequivocally positive data set looking at the combination of reduced pruritus and bile acids with a low diarrhea rate. In addition, we provided a more robust data set by generating additional important information across a wide range of patients from birth to early adulthood with JAG1 and NOTCH2 genetic mutations and predefined endpoint sleep data. Gold standard phase 3 studies like ours provide the highest quality of compelling data for regulators, payers, and prescribers, helping to expedite approvals, pricing and reimbursement and commercial uptake. This is a great day for patients suffering from Alagille syndrome and for the dedicated team here at Albireo. Gold standard phase III studies like ours provide the highest quality of compelling data for payers, regulators, and prescribers. With the very strong ASSERT data, we expect rapid regulatory reviews and approvals, expedited pricing and reimbursement, and a successful commercial launch. The story does not end there. We hope to enroll the last group of patients in the BOLD biliary atresia phase III study and expect to announce full enrollment imminently. We saw an acceleration in PFIC sales last quarter of at least $7 million and are looking forward to launches in additional countries. The company is in a strong position with Bylvay sales continuing to be generated. A solid cash position, two successful phase III studies, and another gold standard study soon to be fully enrolled. We continue to be on a steady pace to drive our aspiration of making Bylvay a billion-dollar drug in the second half of the decade. We thank everybody for joining us, and we will now open the call for questions. Operator? Thank you. If you'd like to ask a question, please press star one on your telephone keypad. A confirmation tone will indicate your line is in the question queue. You may press star two if you'd like to remove your question from the queue. For participants using speaker equipment, it may be necessary to pick up your handset before pressing the star keys. In the interest of time, we ask that you each keep to one question and one follow-up. Thank you. Our first question comes from the line of Ritu Baral with Cowen and Company. Please proceed with your question. Good morning, guys. Thanks for taking the question and congratulations on the top line. I wanted to go, you know, straight to the heart of the marketing question, which is, what are your current plans for the sales force as it stands? Do you have any first thoughts on the differential marketing message that you might go out with? Is it going to be side effect-focused? Will it be efficacy and outcomes? How should we think of that strategy? Thanks. Well, thank you, Ritu. Why don't you talk about how we're thinking about commercialization, Pamela, and then I'll talk a little bit about what we're thinking about from a messaging perspective. Sure. Hi, Ritu. Thank you for the question. We're really excited about this data and well on our way with our preparations for launch. Really what we're doing is gonna leverage our experience in PFIC, taking advantage of our existing infrastructure. We may add a few people to our field teams, but overall, we'll leverage that very strong structure that we have in place and the relationships both with physicians and payers. Yeah. Ritu, that's the beauty of our model, right? You know, we built an infrastructure for PFIC. That infrastructure in Europe and the U.S is working well. We just add Alagille, and then we hope to add biliary atresia sometime in the future. You know, from a messaging perspective, look, this is the first time you've had a gold standard phase III study with such unequivocal results. It's also the first time that it is a wide set of data. As I said in my prepared comments, you know, we're studying a wider range of patients. We studied both mutations and we have prospective sleep data, which I think will have a really big impact. Then third, as I said, this is the first time in, you know, in Alagille syndrome, which is a really difficult disease to study. These are heterogeneous patient populations. In previous placebo-controlled studies, you know, failed to meet the primary endpoint. We not only met the primary endpoint, but we smashed through that, and we had consistent data over time. We believe we have a very strong competitive platform as we launch Bylvay for Alagille syndrome. Thank you. Our next question comes from line of Seamus Fernandez with Guggenheim Securities. Please proceed with your question. Hi, guys. Good morning. Congratulations. This is Evan weighing in on behalf of Seamus Fernandez, who is on a plane. We have two questions, one for the team and one for Dr. Ovchinsky. You know, just from the team, you know, can you really discuss just a follow-up on Ritu's question. Can you kinda discuss the ability to commercialize Alagille? I guess, how do you envision the PFIC data accelerating potential commercial potential, especially as we think about, you know, the EU and US dynamics? Then for Dr. Ovchinsky, you know, as we think about having two datasets, you know, how would you envision the treatment algorithm for patients, whether they're IBAT-naïve patients or existing IBAT patients? Any color you can help provide there. Thanks. Hey, Evan. Thanks for the question. Let me take that first question, and then I'll ask Dr. Ovchinsky to comment on your second one. You know, like, as we think about commercialization, the one thing that, you know, we've done is we have a commercial structure here in the U.S. and a commercial structure in Europe. Lean commercial structure, and it's working really well. That being said, we've had to learn a few things during the process, and I think now, you know, we've got a really good sense of the customers, how our team works, you know, et cetera, et cetera. We think of this as a really, as a global opportunity We also believe that having this unequivocal phase three data and breadth of data is really going to help us, and we believe we'll be a fast follower in here in the U.S., and let's see what happens in the European countries, right? You remember it's a regulatory process, and then it's a pricing and reimbursement process.Three to six months for clinical assessments and anywhere from three months to a year in economic assessment and contracting. Remember that we will be going to those payers with a level one data, phase three data, and as you can see today, very clear data. We've already gone through pricing and reimbursement in multiple countries. We already have contracts in place, so just think about this as a variation. you know, I think we believe that, you know, with an approval in Alagille, we'll be competitive here in the U.S., and we'll be competitive in Europe as well. Over to you, Dr. Ovchinsky. How will this change the landscape of treatment for this patient population? We're excited to have a drug that we can start as early as infancy with a convenient mode of administration. We are hopeful that starting this drug as early as feasible for infants will prevent some of the, you know, terrible symptoms that we see with Alagille or at least lessen them. It will improve pruritus. It will improve quality of life for these patients and families. Long term, you know, we are hopeful that this will decrease the need for liver transplantation in this complex patient population. Thank you. Our next question comes from the line of Andreas Argyrides with Wedbush Securities. Please proceed with your question. Thank you. Good morning, and congrats on the fantastic results here. They're as good as it gets. Maybe just continuing from the last question for Dr. Ovchinsky, and you made some comments about prescribing this in children as early as infancy. Could you just remind us how important it is that these patients are treated as early as possible? I have a follow-up. The whole idea of treating children early, you know, besides even the pruritus and besides, you know, the significant quality of life issues is the significant reduction in bile acid levels, demonstrates to us that there is a huge potential for these medications, to lessen the chance of a child having a need for a liver transplant. The earlier we start this drug, the more likely we'll have a long-lasting effect on the native liver, and the more likely we'll have a great native liver survival in this patient population. Okay, great. I should add. Sorry. Some children may not even have an opportunity to have a liver transplant because they have severe cardiac disease, and they're not candidates for transplant. This can really change a lifetime landscape for this patient population. Okay, fantastic. For the management team, do you anticipate getting a similar label in patients as young as three months for Alagille? How are you thinking about various doses? Thanks. Thanks. Yeah, thanks for the kind comments, Andreas, and thanks, you know, for the questions. Look, it's pretty early for us to talk about the label. We literally just got the data. We will be filing as quickly as possible in both the U.S. and Europe. You know, let's see what the regulators say, you know, both in regards to, you know, what the label will look like and the dose. One step at a time. All right. Well, we're all excited, so sorry for jumping the gun there. Congrats again. Thanks. Thank you, Andreas. Thank you. Our next question comes from the line of Brian Skorney with Baird. Please proceed with your question. Hey, thanks. Good morning, guys. Congrats on the data. Maybe just start with, I have a question for Dr. Ovchinsky. Maybe you can just talk about a little bit about the tolerability that you see in the study, and maybe compare and contrast it to other IBAT inhibitors. I know there's not really apples to apples, comparative studies at this point. The diarrhea rate looks really low relative to, the commercial IBAT in ALGS right now. Ron, I think you said there was one SAE that was deemed possibly drug-related. I was just wondering, can you tell us about that case? Maybe Dr. Ovchinsky, you can answer the first question, then Jan, if you could take on that second one, please. Sure. The tolerability was, you know, pretty good considering, you know, our clinical experiences. This was, I believe matching our clinical experience with mostly just mild gastrointestinal, side effects, diarrhea that have not had any patients, drop out of the study, or, you know, stop participation. The side effects were relatively mild. Diarrhea is not unusual in this patient population, and it really didn't impact, patient participation significantly. This is very similar to our clinical experience with IBAT inhibitors. Yeah, this is Jan here. With regard to the SAE, as I mentioned, there were two in the placebo group and five in the treated group. Remember, this is a heavily severe disease or disorder. You know, it was only one deemed possibly related to study, right? We are obviously analyzing the information to understand more of the specifics of this SAE. Again, remember what I said, that all patients completed the study. Thanks for your questions, Brian. Thank you. Our next question comes from the line of Eun Yang with Jefferies. Please proceed with your question. Thank you. Congrats from my side as well. One question to Ron and the second question to Dr. Ovchinsky. Ron, given that the Bylvay is based on pricing is based on the body weight and you are using higher dose in ALGS, how do you think about pricing? To the doctor, next year you have two IBAT inhibitors for Alagille syndrome. When you have a new patient coming in, how would you decide which drug to use? Thank you. All right. Thanks for the kind words, Eun. First of all, it's too premature to know about pricing. You know, frankly, we've got to file, we've got to see what the label says, right? Once we have a better sense of what the label looks like, right, then we'll have a better idea of how we would be pricing Bylvay, you know, for Alagille syndrome. Over to you, Dr. Ovchinsky. Sure. Look, it's great to have multiple options. You know, really this is such a heterogeneous disease. What works for one patient may not work for the same, for the next patient. Tolerability might be different and very unique to each patient. I think it's great to have an opportunity to potentially start this at a younger age. I am most looking forward to that in the patients who are now being diagnosed earlier and earlier in life because of our improved genetic testing. Tolerability of capsule administration may also be different. I think for our community of clinicians, it's great to have multiple options. Thank you. Thank you. Our next question comes from line of Ed Arce with H.C. Wainwright. Please proceed with your question. Hi, good morning. Thanks for taking my questions, and let me add my congrats on really robust data sets. First, I wanted to ask, the PRUCISION score caregiver instrument that was used for the primary endpoint, was that identical to that used in PEDFIC 1? I f not, were there any adjustments that you could clear up for us? A lso just wondering, you mentioned as well that almost all the patients rolled over to the extension study. Were there any circumstances that you could discuss related to those patients that chose not to roll over? And then I have a follow-up. Thank you. Well, Ed, thanks very much for those kind words. Maybe I'll hand that over, you know, to Jan to answer those questions. With regard to the first question on the PRUCISION instrument, that would stay the same that we used for the PEDFIC. On the second part, as I said, all patients completed the study. You know, we are analyzing the data more and we'll obviously present more data as we come to a medical congresses, of course. Yeah. Ed, you know, it's top-line data. You know, as Jan said, majority of patients rolled over, pretty high rate of rollover, right? The nice thing about that is that's gonna give us lots of data, right? We're gonna have the ASSERT 24-week data. We're gonna have patients that have been in the open label part of that, and we'll share more of that information once we get to a medical conference. Fantastic. To follow up, just wondering about how we should think about the timeline. As you mentioned, filing an sNDA in the first quarter of next year. What are your thoughts on a potential priority review? In terms of clarity on the timelines regarding commercialization, and specifically adoption, what are your thoughts, not only in the US, but particularly in the EU, given the multiple steps to adoption there. Thank you. Well, Ed, we're gonna move fast, right? To be clear, we're planning on filing immediately. You may recall my prepared comments. I said with the PFIC submission, we hit a new industry benchmark less than 70 days. Remember, that's a bigger submission. That has CMC, clinical, et cetera. In this case, this is a supplement. Both in the U.S. and in Europe, you know, we expect to get that in quickly, and we expect to have approvals next year as well. You know, as it relates to your comment about commercialization and I think competitiveness, again, I think, you know, here in the U.S., there are a number of patients that are looking for different options. We already see that in our EAP program, so there's opportunity here in the U.S. In Europe, given our success with pricing and reimbursement, you know, remember, regulatory approval is important, but quite frankly, pricing and reimbursement almost takes longer. Given our success with PFIC and the track that we have, we anticipate being rapid through both of those things, so we'll be able to compete. Great. Thanks again. Thank you, Ed. Thank you. Ladies and gentlemen, as a reminder, if you'd like to join the question queue, please press star one on your telephone keypad. Our next question comes from the line of Tim Lugo with William Blair. Please proceed with your question. Thanks for the question, and congrats on the what looks like best-in-class data. Ron, I believe you mentioned it's a bit early to discuss your product label, but the other product label out there does have 50% diarrhea, 40% rates of vomiting on the label, no sleep data. It looks to me like you could argue for switching patients. What do you think is kind of the approximate penetration of the other IBAT inhibitor in Alagille right now? How many are kind of patients that are out there that are naive to IBATs versus experienced in your view? You know, first of all, thanks for the questions and comments, Tim. I think, you know, both IBAT inhibitors are just on the market. We're both in the early stages of launches, right? I think, you know, every day and every month, we're discovering new pockets of patients, so there's plenty of opportunity out there. Given that in the case of Alagille syndrome, you know, this is 25,000 patients across the U.S. and Europe, so it's a much bigger opportunity. To your point of switching, you know, I would just go back to Dr. Ovchinsky's comments, right? Currently, Dr. Ovchinsky and the rest of the prescribing community have one option, and the next option is surgery, right? There are patients that are doing well on the other IBAT inhibitor, but I think there are other patients who are not getting the response that they need or perhaps are having some side effects that they're just putting up with. We believe there's a real opportunity there given the data that we have with Bylvay, where you see really good efficacy on pruritus and bile acids and a really clean safety profile and nice tolerability. You know, we believe there's opportunity in patients that haven't treated as well, and there is switch opportunity as well. Understood. In your prepared comments, you know, you mentioned the 2 for 2 hit rate in pediatric cholestatic disorders. Could you dig into a bit about how this makes you more comfortable with BOLD and efficacy in biliary atresia? When you think about it, Tim, remember no one had done a study in PFIC before, a phase 3 study. Nobody had done a phase III study in Alagille syndrome before. Nobody had done one. You know, and remember, there's no guidance. There's no guidance. There's no clinical guidance. There's no endpoint guidance, you know, from the regulator. Our team here in Albireo figured it out for PFIC, right? Our team here in Albireo figured it out for Alagille syndrome. Pretty confident that our team here in Albireo has figured it out for biliary atresia as well. Remember, fundamentally, these diseases are diseases of cholestasis. Cholestasis is effectively bile acid in the wrong place. What does Bylvay do? It is the most powerful reducer of bile acids on the market, and it's been demonstrated in PFIC that it can reduce bile acids, now demonstrated in Alagille syndrome, makes us even more confident that we can do the same in biliary atresia. Great to hear. Congratulations to the team. Thank you, Tim. Thank you. Our next question is a follow-up from Eun Yang with Jefferies. Please proceed with your question. Thank you. In the Alagille study, the diarrhea on Bylvay was 11%. Is that all grade diarrhea or is that, you know, certain grade two or higher? This is Jan here. As I said, the AEs were all mild or moderate. Mild or moderate. Okay. With regard to specifics, that was overall for the AEs. As I said, this is just the top-line data. We need to analyze the data more, and we will obviously present this at the upcoming medical congresses. More details to come. Okay. Thank you. Thank you. Ladies and gentlemen, this concludes our question and answer session. I'll turn the floor back to Mr. Cooper for any final comments. Great. Thank you very much, operator. It's worth reiterating how proud we are to deliver these positive phase 3 results to the Alagille and cholestatic liver community. We again thank the investigators, the patients, and the families for their involvement and commitment and cheers over the past years. We'll keep you updated as we continue to advance to filing with the regulatory authorities as well as advancing Albireo's mission to provide hope to families of patients with liver disease and the entire liver community. Thank you all for your continued support. Thank you. This concludes today's conference. You may disconnect your lines at this time. Thank you for your participation.