Mirum Pharmaceuticals, Inc.

Hello everyone and welcome to the Mirim Q3 2022 Business Update. My name is Emily and I'll be coordinating your call today. At the end of today's presentation, you will have the opportunity to ask a question by pressing start followed by the number one on your telephone keypads. I'll now turn the call over to our host, Ian Clements, CFO of Mirim. Please go ahead, Ian.

Thanks, Emily. Good morning, everyone. I'd like to welcome you to Mirim Pharmaceuticals' third quarter 2022 conference call. I'm joined today by our president and CEO, Chris Peets, our chief operating officer, Peter Radovich, our head of R&D, Pam Vick, and Professor Richard Thompson from King's College London. Earlier this morning, Miriam issued a news release announcing the company's results for the third quarter of 2022. Copies of this news release and SEC filings can be found in the investor section of our website. Given that we have Professor Thompson on the call today to discuss the exciting full results from our phase three March PFIC study, as presented earlier this week at ASLD, we intend to keep the rest of our updates brief. Full details on updates from the quarter can be found in our news release and the 10Q issued this morning. Before we begin, I'd like to remind you that during the course of this conference call, we'll be making certain forward-looking statements about MIRIAM and our programs based on management's current expectations, including statements regarding MIRIAM's business plans, development programs, strategies, prospects, market opportunities and financial forecasts and guidance. 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 the results anticipated by these statements. Investors should read the risk factors set forth in Miriam's 10-K for the year ended December 31st, 2021, and any subsequent reports filed with the SEC. With that said, I'd like to turn the call over to Chris. Chris. Thank you, Ian.

And good morning to everyone joining us on the call today. The last quarter for Miriam was packed with major milestones as we continue to realize our vision of bringing life-changing medicines to patients suffering from rare diseases around the world. The Live Marley launch in the U.S. continues to track well with 47.2 million in net sales year to date, on track for an estimated 70 million in net product sales in 2022 for a strong first full year of approval. Setting the stage for growth outside the U.S., we recently received a positive CHMP opinion for Live Marley in Europe for treatment of cholestatic colitis and Allochill syndrome, two months of age and older. And our launches in key European countries next year will also be supplemented by further approvals and demand from partner markets, like the recently announced approval in Israel. And we're excited about the potential for label expansion based on the positive results of the March PFIC Phase 3 study. These data build on the years of treatment experience we have in Allochill syndrome and PFIC with a broader genetic type and higher response rate than earlier studies, showing the potential for improved outcomes for patients. It is a moment where the Mirim team is hitting its stride on both commercial performance and realizing the value of our pipeline. The great advances we've made at Mirim are only possible with the participation of patients and dedicated researchers. On that note, we're delighted to have Professor Thompson join us today to share the recently presented details from the March PFIC Phase 3 study. And with that, I'll pass the call over to Peter for a couple brief remarks on the commercial business before diving into the new clinical data.