Albireo Pharma, Inc.

Good morning and welcome to the Alvareo Pharma Inc. fourth quarter and year-end 2021 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 conference, please press star zero on your telephone keypad. Please note that this conference is being recorded. I'll now turn the call over to your host, Paul Arndt, Managing Director of LifeSci Advisors. Thank you. You may begin.

Thank you, Operator, and good morning, everyone. Thank you for joining today's call. This morning, Albareo issued a press release highlighting its recent business accomplishments and reporting its financial results for the fourth quarter and year-ended December 31, 2021. This press release is accessible by the company's website at www.albareopharma.com. Before proceeding, we would like to take 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 Media and Investors section of our website at albareofarma.com or on the SEC's website. Any forward-looking statements represent our views as of today, Tuesday, March 1, 2022, and should not be relied upon as representing our views as of any subsequent dates. We undertake no obligation to publicly update these statements. Now, it is my pleasure to turn the call over to Ron Cooper, Albareo's President and Chief Executive Officer. Ron?

Thank you, Paul, and thank you, everyone, for joining us this morning. With me today are Simon Harford, our Chief Financial Officer, Pamela Stevenson, our Chief Commercial Officer, and Dr. Jan Matsen, Chief Scientific Officer and Head of R&D. So, when we step back and reflect on 2021, it was a historic year for Alvareo. It really was one for the record books where our journey to bring a new first-in-class medicine to children and families managing the high burden of rare disease was realized with the approval of Bill Bay in both the U.S. and Europe. Last summer, this approval transformed our company from a clinical stage company to one with an approved product that is building an integrated biopharmaceutical company. Barrios, a company with a tremendous amount of growth potential across three different drivers of value. First, the global Bilbao launch in PFIC. Second, the expanded use of Bilbao in allogel syndrome and biliary atresia with our phase three assert and bold studies with the goal of adding two additional indications. This would allow us to provide a new treatment option for the approximately 100,000 colostatic liver disease patients worldwide towards our ambition to make Bilvay a billion-dollar product in the second half of the decade. And third, the rapidly emerging early-stage products. So let me begin by speaking about the Bilvay PPIC launch. To date, we are only going in one direction, starting with delivering on a fast update. As reported in our press release this morning, we ended 2021 delivering $7 million in Build Bay product revenue. Original guidance for 2021 was 3 to 4 million. We updated this at the start of the year to 6 to 7 million. So we're thrilled to deliver on the high end of the range. Pamela will tell you a bit more about the drivers of performance, but the key takeaway is, The response from prescribers is terrific. We're hearing from both HCPs and patients that Bilvay is making an impact, and we're seeing a fast launch update. We expect to continue to see growth from these initial patients, as Bilvay is a chronic therapy with weight-based dosing. And as patients continue to grow, they will increase their daily medication. Building on that base, we will continue to initiate new patient prescriptions netted against some discontinuations each quarter in the U.S. and Germany. And then beyond those two opportunities for growth, as the year progresses, we're planning for additional country launches in Europe as pricing and reimbursement is achieved, like most recently in the U.K. So overall, our opportunity with BuildVac continues to grow with the potential for great impact on families who are caring for children with cholestatic liver disease. To get into more detail in the launch, I'll turn it over to Pamela to take you through key metrics and achievements. Pamela?