Mirum Pharmaceuticals, Inc.

Good afternoon. I would like to welcome you all to the Miriam Pharmacuticals conference call. My name is Brica and I will be the event specialist running today's call with you. All lines are on mute for the presentation portion of the call today with an opportunity for questions and answers at the end. If you would like to ask a question, please press star then one on your telephone keypad. I would now like to pass the conference over to your host, Andrew McKibbin. Vice President of Investor Relations, to begin. So, Andrew, you may begin.

Thanks, Priyanka, and good afternoon, everyone. I'd like to welcome you to Miriam Pharmaceuticals' third quarter 2023 conference call. I'm joined today by our President and CEO, Chris Pease, our Chief Operating Officer, Peter Radovich, our Head of Research and Development, Pam Begg, and our newest team member, Eric Bjerkel, our Chief Financial Officer. Earlier today, Miriam issued a news release announcing the company's results for the third quarter 2023. Copies of this news release and SEC filings can be found in the investor section of our website. Full details and updates from the quarter can be found in our news release and 10Q issued today. 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 Merrim's current and future business plans, development programs, and regulatory expectations, strategies, prospects, market opportunities, and financial expectations. Merrim is under no duty yet to update these statements, and they 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 Merrim's 10K for the year ended December 31st, 2022, and any 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 to everyone. This was another strong quarter of execution at Merrim. The team has continued to grow our business by focusing on delivering life-changing medicines for patients and their families living with rare diseases. We've achieved multiple goals this quarter, including realizing total revenue of $47.7 million for the quarter. We saw continued strong global adoption of Lipmarli. We also completed the acquisition of two high-impact and synergistic commercial medicines, Kinadol and Colbon. We continued our commitment to delivering on our pipeline with the recent positive Restore Phase 3 study readout and upcoming clinical and regulatory milestones. And all of this has been accomplished while improving our financial position in terms of performance and balance sheets. These achievements come alongside another special milestone for Mirim coming up this weekend, our five-year anniversary of launching the company. I'd like to thank the Mirim team's dedication, perseverance, and unmatched spirit for making all of our success possible in a short time, with much more to come. Now, moving to Live Marley, we see steady demand growth in the U.S. and internationally. This reflects the positive impact of Live Marley for patients and families in the Allershield Syndrome community, and also the focused execution of the Mirim team to make this important medicine accessible to patients around the world. I am proud of what we've been able to accomplish with Livmarley and Al-Jil syndrome and what that means for our execution on our expanded portfolio. This quarter, we grew our business with the acquisition of two commercial medicines, Kinadol and Colbomb, and have assumed sponsorship of a broadly used cholestasis genetic testing panel, vital for diagnosing several rare genetic disorders that is free to patients and providers. This has created a leading pediatric hepatology franchise and also brings significant and growing revenue contribution with approximately $100 million in annual net product sales from the bile acid portfolio. Regarding our pipeline, we have made good progress here as well. In October, we announced positive data from the Phase III Restore Study, evaluating Kinadol in patients with cerebral tendinous xanthomatosis, or CTX. The data showed Kenadol has a significant impact across key measures of the disease and this phase three data set and the potential approval of Kenadol for CTX is a critical step forward for CTX patients. We plan to submit a new drug application for CTX to the FDA in the first half of 2024. We also look forward to significant upcoming milestones and opportunities for Lyfmarly with the March 13 PDUFA date for PFIC and our upcoming phase two data and biliary atresia. And for Elixabed, we expect to conduct our interim analyses in PSC and PBC in the first half of next year. Now, before I turn the call over to Peter to discuss our commercial business, I want to welcome our new CFO, Eric Bjerkel, who joined Mirum in September. We are thrilled to have Eric and his extensive leadership experience helping to drive the growth and value creation we see ahead for Mirum. We'll hear from him later in the call. And with that, I'll turn the call over to Peter. Peter?