Albireo Pharma, Inc.

Good afternoon and welcome to the Alvareo Pharma second quarter 2022 earnings 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 Wittstum, Managing Director of LifeSci Advisors. Thank you. You may begin.

Thank you, Operator, and good afternoon, everyone. Thank you for joining today's call. This afternoon, Alvareo issued a press release highlighting its recent business accomplishments and financial results for the first quarter ended June 30th, 2022. This press release is accessible via the company's website at www.alvareofarma.com. Before proceeding, we'd 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 factor section of our most recent Form 10-K and our subsequent SEC filings. These filings can be accessed from the investor section of our website at www.albareofarma.com or on the SEC website. Any forward-looking statements represent our views as of today, August 15, 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, Al Barreo's President and Chief Executive Officer.

Ron? Thanks, Hans, and thank you everyone for joining us this afternoon. With me today are Simon Hartford, our Chief Financial Officer, Pamela Stevenson, our Chief Commercial Officer, and Dr. Jan Motsen, Chief Scientific Officer and Head of R&D. We estimate that there are about 100,000 cholestatic liver disease patients around the world that could benefit from bilbao therapy. And in Q2, we had another strong quarter. accessing these patients through excellent execution of both our commercial and clinical development plans. Old standard Phase III studies like ours provide the highest quality of compelling data for payers, regulators, and prescribers. Our approach resulted in Build-A-US and EU approvals in PFIC, and we expect the same for allogel syndrome and biliary atresia. Ethic country commercialization rollout continues as planned. We're looking forward to a major phase three readout in algal syndrome around the corner, and expect the bold Villarreal-Theresa study to be fully enrolled this year. We're building short-term and long-term corporate value at a steady pace to drive our aspiration of making Bill's a billion-dollar drug in the second half of the decade. On top of Belvay, our promising earlier stage assets, A3907 and A2342, are progressing exactly according to plan and will become valuable growth drivers. Strong financial footing and a team of years of expertise in bile acid modulators, we're poised to deliver our plan and create additional value. As we shared with you in the first half of 2021, we have a global launch strategy for Billvape, achieving global net product revenues of $5.9 million in the quarter. While sales are important, the more important metric is patient capture, which relates to the long-term value of our drug. I'm pleased that we now have 245 total bill pay patients, either on drug or in process. On a quarter-to-quarter basis, we've had consistent new patient capture. We continue to make excellent progress with global bill pay launch and gain important market insights along the way. This quarter, we had a larger change in the mix of babies versus adults on therapy. We're also finding that in the U.S., patients are a bit more dispersed than expected. longer than originally anticipates to get to them. Pamela will provide more detailed update on these topics and the global launch metrics. You will see that we've adjusted the metrics in a new format based on investor feedback. The metrics are simplified and now add up to total bill bait patients. As we all know, PFIC is our smallest syndication, but we're making excellent progress in our objective of expanding beyond PFIC as Bilvay is a pipeline in the product. We're on track in allogeal syndrome and expect to report top-line data for the Phase III ACERT study in the fall, which is really exciting. ACERT is a gold standard prospective intervention trial with 35 sites across North America, Europe, Middle East, and Asia Pacific. With that in mind, we're also very excited about the progress to date with our Phase 3 BOLD study in biliary atresia with enrollment on track to be completed by the end of this year and a top-line data readout in 2024. Phase 3 BOLD trial is the first and only Phase 3 evaluating IVAT inhibitor in biliary atresia with clinical trial sites spanning the U.S., Europe, Latin America, and China. Our exchange with the FDA has been very productive, and we're excited about Bilbao's potential in this indication. Bilbao atresia is the most common pediatric cholestatic liver disease and the number one reason for pediatric liver transplants across all diseases. And finally, We're pleased with the two recent appointments to our Board of Directors, strengthening our company with the addition of Susan Alesina, Vice President, National Business Development and Alliances at Boston Children's Hospital, and Hibby Dable, former President and CEO of Acceleron Pharma. Susan is a strong leader who, in her role at Boston Children's Hospital, provides us excellent insights into the healthcare system challenges and opportunities. In addition to her experience with a major children's hospital, Susan brings a rare blend of both big pharma and biotech strategic planning, business development, and communications experience. Habib is another successful leader who grew Acceleron, which is eventually sold to Merck for over $11 billion. Habib brings excellent biotech CEO experience as well as big pharma scale experience for his many years at Bayer. We're fortunate to have both these great leaders join our board. Now let me turn it over to Pamela, who will take you through the progress for our global launch of BuildA and Pfefic. Pamela?