Mirum Pharmaceuticals, Inc.

Hello everyone and welcome to the Miriam Pharmaceuticals third quarter business update conference call. My name is Victoria and I'll be coordinating your call today. If you would like to ask a question during the presentation, you may do so by pressing star followed by one in your telephone keypads. If you have joined us online, please press the red flag icon. I'll now hand over to your host, Ian Clements, Chief Financial Officer. Ian, please go ahead.

Thank you, Joy, and good afternoon everyone. I'd like to welcome you to Miriam Pharmaceuticals' third quarter 2021 conference call. I'm joined today by our President and CEO, Chris Peets, Pam Vig, Head of Research and Development, and Peter Radulich, Chief Operating Officer. Earlier this afternoon, Miriam issued a news release announcing the company's results for the quarter ended September 30, 2021. Copies of this news release and SEC filings can be found in the Investors 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 Miriam and our programs based on management's current expectations, including statements regarding Miriam's business plans, commercial and development programs, strategies, prospects, market opportunities, and financial forecasts and guidance. These statements are subject to numerous risks and uncertainties, and actual results could differ materially from the results anticipated by these statements. Investors should read the risk factors set forth in Miriam's 10Q for the quarter ended September 30, 2021, and any subsequent reports filed with the SEC. With that said, I'd like to turn the call over to Chris Beats. Chris?

Thank you, Ian, and good afternoon to everyone joining us on the call today. The third quarter was an exceptional period for Mirum, marked by the FDA approval of Liz Marley for cholestatic pruritus in patients one year and older with allogeal syndrome. The first ever approved medicine in this indication and the first FDA approved product for Mirum. Liz Marley's launch is a tremendous achievement and I'm very proud of our team for the impressive strides made this quarter. We are all humbled and excited about what it means for the allogeal syndrome community And I would like to again extend my thanks and appreciation to the patients, parents, caregivers, investigators, advocates, and employees that got it done. The hard work of the Merum team is delivering results. Our pre-launch preparations have resulted in a strong start in market. Today, Peter will speak to our commercial efforts, including an update on the many partner companies multiplying our efforts to launch Live Marley around the world. This quarter also witnessed several important milestones from our clinical and regulatory efforts. We submitted our application for Live Marley in Europe for the treatment of cholestatic liver disease in patients with algeol syndrome. And just today at the AASLD liver meeting, the Global Algeol Alliance presented landmark data that was part of that submission. These data showed a highly significant improvement in transplant-free survival for patients in Liv-Marley studies compared to a similar untreated group. Overall, a 70% risk reduction was seen. This presentation was the lead oral late-breaking presentation today and received best of liver reading recognition. We believe these results are nothing short of remarkable. Before turning the call over to Peter, I'd like to share a couple of updates on the leadership team. First, I'd like to thank Dr. Ed Tucker, who has served as Miriam's CMO since 2019, supporting the application and approval of Liv Marling, who is leaving the company. We wish him the best of luck as he embarks now on his next professional endeavor. Second, I'm excited to share that our Chief Scientific Officer, Dr. Pam Vig, is being promoted to Head of Research and Development for Miriam. She'll review today's ASLD presentation on our call today. Now, let's turn to an update on the launch. It's early days, but we're confident in the initial progress we've seen.