Hello, and welcome to the Mirum Pharmaceuticals Business Update. My name is Elliot, and I'll be coordinating your call today. If you would like to register a question during today's event, please press Star followed by one on your telephone keypad. I'd like to hand over to Andrew McKibben, Vice President of Investor Relations. The floor is yours. Please go ahead. Thanks, Elliot. Good morning, everyone. I'd like to welcome you to Mirum Pharmaceuticals' Conference Call. I'm joined today by our President and CEO, Chris Peetz, our Chief Operating Officer, Peter Radovich, and our Head of R&D, Pamela Vig. For our Q&A session, we are also joined by our Chief Development Officer, Lara Longpre. Earlier today, Mirum issued a news release announcing its acquisition of Travere Therapeutics' commercial portfolio of bile acid therapeutics for rare genetic pediatric diseases. 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 based on management's current expectations, including statements regarding Mirum's business plans, development programs, strategies, prospects, market opportunities, and financial forecasting guidance. Mirum is under no duty to update these statements, and they are subject to numerous risks and uncertainties, and actual results may differ materially from the results anticipated by these statements. Investors should read the risk factors set forth in Mirum's 10-K for the year ended December 31, 2022, and any subsequent reports filed with the SEC. With that said, I'd like to turn the call over to Chris. Chris? Thank you, Andrew, and good morning to everyone joining us on the call. This morning we announced a landmark transaction for Mirum, reinforcing our position as a franchise leader in Pediatric Hepatology. This acquisition strengthens the growth potential for LIVMARLI and adds scale to our business, both operationally and financially. We have entered into a definitive agreement to acquire the bile acid products, Chenodal and CHOLBAM. This is an exciting moment for Mirum and an important step in line with our five-part strategy to be a high-growth leader in rare disease. The bile acid products are synergistic with our current business and expand our commercial presence for LIVMARLI. This acquisition adds over $100 million in annualized revenue to our rapidly growing commercial business, and we expect the combined business to be approximately cash flow break even after closing, with growth expected across all three products. The acquisition is financed with the concurrent private placement of equity of $210 million that further strengthens our financial position at the anticipated closing. Financing had strong interest, with several leading biotech investors supporting our growth strategy. We are thrilled about what this transaction means for Mirum and the patients we serve. The addition of these medications allows us to expand our services to the pediatric hepatology community and support the diagnosis and treatment options for several genetic disorders impacting the liver. This also provides important financial and operating scale, allowing us to accelerate our strategy to provide high-impact therapies for patients with rare disease. I'll now turn the call over to Peter to discuss a few more details of the commercial business. Peter? Thanks, Chris. Before we dive into the specifics of these important and highly synergistic bile acid replacement medicines, I'd like to provide a brief update on LIVMARLI. Commercial execution of our launches around the world in Alagille syndrome continues to be very strong. LIVMARLI is well positioned for 50% year-on-year growth in U.S. sales, as well as growth from international markets, where launches are progressing well. LIVMARLI is the first and only treatment approved for patients three months and older with cholestatic pruritus due to Alagille syndrome. LIVMARLI is also the only therapy for Alagille syndrome that provides both rapid symptomatic relief and long-term improvement in transplant-free survival. Putting this into context for today's call, we are very excited about the addition of Travere's bile acid portfolio, as we believe having these products in our team's hands supports LIVMARLI's future growth as Mirum's presence with pediatric liver disease prescriber universe expands and deepens. A bit more on the bile acid portfolio, which consists of two approved and well-established therapies, CHOLBAM and Chenodal. These products, as with LIVMARLI, are predominantly prescribed in the pediatric hepatology setting. CHOLBAM is approved in the U.S. for bile acid synthesis disorders and Zellweger spectrum disorders. Chenodal, which is not promoted, is approved in the U.S. for radiolucent gallstones and holds FDA medical necessity status for the treatment of CTX, where it's considered standard of care and substantially all of its use occurs. From a commercial perspective, we see a strong synergistic fit with the bile acid products that yields operating leverage and establishes a franchise in rare pediatric liver disease. The sales and marketing efforts are similar in scope, largely focused on the same prescribing audience. Also, the approach to product distribution, market access, and patient services for these ultra-rare indications are quite similar. We expect the bile acid products to continue to grow at low single-digit rates annually, and we do see upside driven by a potential CTX approval for Chenodal based on the phase III RESTORE study, which Pam will review shortly. Mirum is also assuming sponsorship of the Cholestatic Genetic Testing Panel, a branded diagnostic, which Mirum will continue to provide for free to patients. This program supports the diagnosis of a substantial proportion of children with genetically driven cholestatic liver diseases in the United States, and is highly valued by the pediatric hepatology community. We are excited to take over sponsorship of the program, which reinforces our commitment to supporting patients with a variety of cholestatic disorders, ensuring they receive an early diagnosis and prompt treatment. On the financial side, the bile acid portfolio generated $103 million in sales in 2022. In the first quarter of 2023, the combined portfolio with LIVMARLI, CHOLBAM, and CHENODAL resulted in greater than $55 million in net sales, representing an annualized run rate of $220 million in net sales, which provides Mirum significant cash flow generation going forward, that we can use to fuel our pipeline and further expand our footprint in rare diseases. In summary, this acquisition accelerates our growth and leadership in pediatric hepatology, adding operating and financial leverage to our business. I will now hand the call to Pam to talk about the phase III RESTORE study in CTX. Pam? Thanks, Peter. First, I'll provide some background on CTX and then an overview of the current CTX clinical program. CTX is a rare autosomal recessive disorder in which the bile acid, chenodeoxycholic acid, or CDCA, is not made. In a healthy individual, the predominant human endogenous CDCA is produced from cholesterol in a multi-step pathway. In CTX, the absence of CDCA results in a toxic buildup of cholestanol and bile alcohols throughout the body's tissue, causing a variety of significant problems. These include chronic diarrhea, juvenile bilateral cataracts, cardiac manifestations, tendon and brain xanthomas, as well as progressive and irreversible neurologic deterioration. Diagnosis can be made using biomarkers such as cholestanol and urine alcohol, with confirmation from genetic testing. Chenodal is currently standard of care in CTX and has been shown to reduce cholestanol to normal or near normal levels in patients, with up to 80% reductions observed, with concurrent decreases in urine alcohol levels and improvement in symptoms. The clinical program includes the fully enrolled phase III RESTORE trial, evaluating Chenodal in patients with CTX. The design of the RESTORE study is a randomized, crossover, double-blind, 24-week study of Chenodal in patients with CTX, and the primary endpoint is a change from baseline in 23S-pentol, which is a urine alcohol and biomarker of the disease. Bile alcohols have been shown to be acutely responsive to application and withdrawal of CDCA therapy, and response is observed within days to weeks. Based on previous results, we have high confidence in the success on the primary and key secondary biomarker endpoints. The study is expected to read out in the fourth quarter of this year and is anticipated to support an NDA and label for CTX, as well as provide orphan exclusivity, if approved. We look forward to sharing data later this year. With that, I will now hand the call back over to Chris. Chris? Thanks, Pam. We look forward to this next stage of growth and for the opportunity to broaden our impact for patients with rare disease. As we integrate these new programs, we will build upon the strong relationships that Travere has established with the patient advocacy organizations supporting these communities. We share with Travere a dedication to ensuring connection and partnership with advocates and patients to advance treatment options for rare disease. This is an exciting next chapter for Mirum. This acquisition accelerates LIVMARLI's strong commercial growth and builds a leading franchise in pediatric hepatology. It is also a transformational step in our advancing our five-part strategy to be a high-growth, rare disease company. We look forward to delivering on the promise of our exciting programs and continuing to expand our impact for patients around the world. With that, we'll now take your questions. Operator, please open the call. Thank you. If you would like to ask a question, please press star followed by one on your telephone keypad. If you would like to withdraw your question, please press star followed by two. When preparing to ask your question, please ensure your device is unmuted locally. First question comes from David Lebowitz with Citi. Your line is open. Thank you very much for taking my question. Curious as to how we should look at the financial model going forward, as far as implementing the new therapies in the top line, and what types of changes we should make, with respect to operating spend going forward? Thanks, Dave, for the question. On the financial side, you know, the impact of bringing these products into Mirum, you know, is financially quite attractive and really shows how well these products fit with LIVMARLI from an operating standpoint. We expect that from an operating cash flow standpoint, the business will be cash flow break even the first quarter after closing the transaction, with growing top line, improving that financial performance going forward, with all three products growing. From a modeling standpoint, you know, we see the bile acid business continuing to perform as it has for years. Kind of steady growth, entirely demand driven, that has occurred for years for these products. From a cash contribution standpoint, you know, $60 million or better of annual contribution at the current revenue rates. Really a unique fit with our business in terms of the synergy that we can drive from bringing these products into Mirum. Just one more, if I may. What type of, I guess, acceleration and growth could we expect to see, if the label expansion is achieved? Yeah. I'll actually hand that one over to Peter to talk a bit about the commercial strategy for CHENODAL. Yeah. Thanks, Chris. I think the key point is that today, our best estimates are approximately 10% of patients with CTX are actually diagnosed. As we mentioned, you know, CHENODAL is not promoted. With a label, and obviously the ability to promote and drive awareness and increase diagnoses, you know, one would hope that you could do much better than 10%, and, you know, drive more patients into active management and therapy with CHENODAL. Thank you for taking my questions. Thank you. We now turn to Steven Seedhouse with Raymond James. Your line is open. Great. Thanks so much for taking the questions. Congrats on getting this deal done. Pretty interesting deal for you guys. I was hoping you could just walk through really sort of the from a practical standpoint, how, you know, much will the diagnosis rates of CTX increase, and how do you get that accomplished? You know, assuming the phase three is positive and the label is amended, I'm just curious to sort of quantify what the inflection could be in a successful scenario there. Thanks for the question. First, just kind of a reminder on timelines here. The phase III RESTORE study, we expect data fourth quarter of this year. A milestone coming up, and really based on clear, well-characterized understanding of what the biochemical reaction is for treatment. High confidence in that readout. We'll take that to FDA early next year to submit for approval, and then, you know, have a new NDA with the CTX label that would follow. I'll hand over to Peter to kind of talk about some of the efforts, and how we're thinking about approaching impacting those diagnosis rates. Yeah. Thanks, Chris. I mean, I think it's difficult to provide a precise quantification of what you'd see, but I think you see this story play out in rare and ultra-rare disease a lot, where you have a new therapy and awareness of that is raised across stakeholders, and you can see, you know, doubling, tripling of diagnosis rates. I mean, Pam mentioned in her comments, one of the hallmarks of the disease is juvenile cataracts. There has been some success focusing on pediatric and adult ophthalmologists and young patients with bilateral cataracts. There's a decent diagnostic yield there that one could focus on. There's also potential efforts around newborn screening and other kinds of strategies that I think one could get much more active on with the label and the ability to promote. Great. Thanks for the question, Steven. Our next question comes from Ed Arce with H.C. Wainwright. Your line is open. Hi, good morning. Thanks for taking my questions, and congrats on this highly complementary deal. I think, Pam had mentioned, Chenodal is currently the standard of care for CTX. I just wondered if you could expand on that in terms of the way that, patients are treated today, and if there is any sense for the proportion of current sales, that go to CTX patients. Thanks. Thanks, Ed, for the question. Just from answering the last part of that first. The current, you know, revenue contribution is really entirely CTX. This is standard of care for this setting, and really most diagnosed, nearly all diagnosed patients will be on treatment or will receive treatment. I'll pass over to Pam to talk a little bit about the patient journey. Thanks. At the moment, FDA has given CHENODAL medical necessity status for the treatment of CTX. That's because there are no other treatments available in this population, frankly, this has been used for many, many, many years now. They recognize that there are no other alternatives, it is used as the standard of care across the board in CTX patients. The data that supports the many years of data and the several analyses that have been conducted, there's a, you know, three great data sets, one from the Netherlands, one from Italy, and one from the U.S., all really pointing to reductions in biomarkers, the same ones that are being studied in RESTORE, plus improvement and stabilization in symptoms and improvement in cholesterol to normal or near normal levels. We have really high confidence that the study will read out as it has played out in the real world. Thanks. That's helpful. Thanks for the question. As a reminder, if you'd like to ask any further questions, please press star one on your telephone keypad now. We'll now send to Yasmeen Rahimi with Piper Sandler. Your line is open. Hi, this is Lauren Timmons on for Yas. Just a few questions for us. First, why do this transaction now, especially considering that we're getting closer to the volixibat readouts in 2H23? Secondly, how does the market share of these products currently have across the indication? Thanks. Thanks for the question, Lauren. you know, first on timing, you know, we see this transaction as an exciting way to really accelerate and cement our leadership position in pediatric hepatology. Frankly, any time is a great time to add products like this that have such a unique complementary fit. And we're excited about what that means for LIVMARLI's position and Mirum's presence in pediatric hepatology, both from a prescriber standpoint, but also just across all stakeholders in pediatric hepatology. So from a timing standpoint, we're excited to jump into this transaction now. And at any time, it really makes sense to really cement that leadership position. From a market share standpoint, you know, for all of the indications that CHOLBAM and CHENODAL are used for in the pediatric hepatology setting, they really are standard of care. I mean, these are bile acid replacement products for severe genetic disorders that have no other effective therapies that fill the role that CHOLBAM and CHENODAL do. They are critical therapies and really have, for diagnosed patients, really play a cornerstone role in care for those patients. Perfect. Thanks so much, and congrats again, guys. Great. Thank you. Thanks for the question. This concludes our Q&A. I'm going to hand back to Chris Peetz, President and CEO, for any closing remarks. Great. Well, thanks, all, for joining the call today. Really appreciate the support for Mirum and our growth trajectory, adding these exciting new products, and on our path to be a high-growth rare disease company. Have a great day. Ladies and gentlemen, today's call is now concluded. We'd like to thank you for your participation. You may now disconnect your lines.