Albireo Pharma, Inc.

Good morning, and welcome to the Albarrio Pharma Third Quarter 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 call, please press star zero on your telephone keypad. Please note that this conference is being recorded. I'll now turn the conference over to your host, Paul Arndt, Managing Director. You may begin.

Thank you, operator, and good morning, everyone. Thank you for joining today's call. This morning, Albarrio issued a press release highlighting its recent business accomplishments and reporting its financial results for the third quarter ended September 30, 2021. This press release is accessible via the company's website at www.albarriopharma.com. Before proceeding, we would like to note that management's comments 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 investor section of our website at www.albariopharma.com or on the SEC's website. Any forward-looking statements represent our views as of today, Thursday, November 4th, 2021, 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, Alvarez 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. Pat Horn, our Chief Medical Officer. This is a historic quarter for Alvareo, as we achieved our first product approvals in the U.S. and Europe and successfully launched BuildAid. I'm proud of our organization's ability to deliver and execute as planned. If you go back in time, we committed to enrolling and reporting top-line data for the PEDFIC Phase III study in mid-2020. We committed to approvals and the launch of BILVE in the second half of 2021. We committed to starting two additional Phase III studies in algeal syndrome and biliary atresia in 2020. We committed to taking a next-generation ASBT inhibitor into the clinic in the first half of the year. We have delivered on all of these commitments and we expect the same going forward. Delivering commercial success with Bilve and advancing our pipeline as planned. In this quarter, we not only received product approvals in the US, EU and UK and launched Bilve globally, but we also shipped finished goods and generated the first partial quarter of sales for Bilve with revenue generation in the US and international which transformed us into a commercial company. The launch is going well, right to plan, and we're delivering on expectations. Bilve is fulfilling a clear market need for the first drug treatment auction. Doctors like it and payers are covering, and our team is delivering on fast launch uptake. We've generated Bilve sales, and we're just at the starting point for Alvareo and the journey to build a great liver company. We're looking forward to delivering BILVE launches in more countries, two BILVE fees, three clinical trials, and advancing two new next-generation compounds. Focusing on BILVE, the launch is going as planned, and Pamela will provide a clear picture of the launch status. The stories we hear and the lives we are impacting across geographies and PFIC types demonstrate the high unmet need and impact of BILVE. For example, We had two siblings, ages 16 and nine years of age, with the rare PFIX6 subtype. Both children have been on various off-label medications for many years that haven't been effective in providing relief from the pruritus. After living with these unrelieved symptoms for so long, they're excited to have Belvay as a new treatment option. The theme of getting better and better is one you will hear today, from launch to access, to our clinical programs and progressing pipeline. I am pleased to share that things keep getting better. We will share details on our progress by taking you through and covering, one, the Bill of A launch, two, key actions to penetrate the estimated 2,500 global PFIC patient opportunity, three, update on the progress of our exciting near-term pipeline, and four, financial progress. Starting with the launch of Bill of A, As this is the first quarterly call since the approval and launch, we surveyed several stakeholders to determine the most useful metrics to share with you on an ongoing basis. These stakeholders suggest that we provide the right balance of too few or too many metrics. Our plan would be to update our metrics every quarter going forward. In this quarter, we'll take time to explain each metric and provide an update. Note that this is the first quarter, This first quarter is a partial quarter, and given that approvals occurred at the end of July, let me turn it over to Pamela to explain the metrics. We'll be sharing with you and provide you an update. Pamela?