Mirum Pharmaceuticals, Inc.

Good afternoon, ladies and gentlemen. Thank you for joining today's Merrim Pharmaceuticals Reports Q4 year-end 2023 financial results and provides business update. My name is Tia, and I will be your moderator for today's call. All lines will be muted during the presentation portion of the call with an opportunity for questions and answers at the end. If you would like to ask a question, please press star one on your telephone keypad. It is my pleasure to pass the call over to Andrew McKibbin, Vice President of Investor Relations and Finance. Please proceed.

Thanks, Tia, and good afternoon, everyone. I'd like to welcome you to Miriam Pharmaceutical's fourth quarter 2023 conference call. I'm joined today by our CEO, Chris Peets, our President and Chief Operating Officer, Peter Radovich, our Chief Scientific Officer and Head of Research, Pam Bigg, our Chief Medical Officer, Joanne Kwan, and Eric Bierkult, our Chief Financial Officer. Earlier today, Miriam issued a news release announcing the company's results for the fourth quarter and full year 2023. 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 call, we will be making certain forward-looking statements about Miriam and our programs based on management's current expectations, including statements regarding current and future business plans, development programs and regulatory expectations, strategies, prospects, market opportunities, and financial expectations. Miriam is under no duty to update these statements, and they are subject to numerous risks and uncertainties. And actual results could differ materially from those results anticipated by these statements. Investors should read the risk factors set forth in Miriam's 10Q for the quarter ended September 30, 2023, and the subsequent reports filed with the SEC. With that said, I'd like to turn the call over to Chris.

Chris? Thanks, Andrew. And good afternoon, everyone. I'm excited to kick off an update on the many achievements for Miriam in 2023, another year of significant growth for us, and cover highlights for what lies ahead for the company. Our continued progress in 2023 and opportunity ahead reflects the dedication of the Mirim team to making a difference in the lives of patients and their families around the world. Over the year, we transformed our business with a broadened reach to patients in the U.S. and internationally, achieving $179 million in net product sales and 142% year-over-year growth in total revenue. This was driven by continued strong growth for Live Marley and the expansion of our commercial portfolio with the acquisition and integration of Keenadal and Colbon. We have now built a growing, self-sustaining, leading rare disease business that is positioned for a great 2024 and beyond. The last year has shown the value creation potential of our strategy to drive growth in our commercial medicines, unlock the potential of upcoming label expansion opportunities, leverage our expertise in cholestasis in adult settings, and continue to grow the pipeline. Looking at the year ahead for execution on our strategy, overall from the current commercial business, we expect to achieve $310 to $320 million of net product revenue in 2024. This is expected to be driven by growth across all three commercially available medicines. We also have multiple regulatory and clinical catalysts this year to advance our pipeline. for Livmarley and PFIC. We are on track for our PDUFA date on March 13th. We're excited for the opportunity to bring the strong results of the March PFIC phase three study to patients with a potential label expansion. We're also preparing for the submission of the positive restore phase three results of Kinadol and CTX in the first half of the year, an important label enabling opportunity. And we've also made great progress with the VISTAs and Vantage studies for Velixibat and PSC and PDC. Patients for the interim analyses have been enrolled, and we expect to conduct the dose selection interims of these adaptive studies in the first half of the year. We see the PFC program as an opportunity to bring the first-ever therapy to market for this progressive, burdensome disease. I'm proud of all of our progress in 2023 and the potential ahead for MIRA. We look forward to continuing to grow the impact of our programs, providing life-changing medicines to patients with rare disease. Now, before I turn the call over to Peter to discuss our commercial business, I wanted to welcome our new chief medical officer, Dr. Joanne Kwan, who joined Miriam in January. We are thrilled to have Joanne and her extensive leadership and scientific expertise helping to drive the value creation we see ahead for Miriam. We'll hear from her later on this call. And for now, I'll turn the call over to Peter to discuss our commercial business. Peter?