Mirum Pharmaceuticals, Inc.

Good afternoon and thank you for attending today's Merham Pharmaceuticals fourth quarter business update call. My name is Amber 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 at any time. It is now my pleasure to hand the conference over to our host, Ian Clements, CFO of Merham Pharmaceuticals. Ian, please proceed.

Thanks, Amber, and good afternoon, everyone. I'd like to welcome you to Miriam Pharmaceuticals' fourth quarter and year-end 2021 conference call. I'm joined today by our President and CEO, Chris Peets, our Chief Operating Officer, Peter Radovich, and our Head of R&D, Pam Vig. Earlier this afternoon, Miriam issued a news release announcing the company's results for fourth quarter and full year ended December 31st, 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, 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 Peets. Chris?

Thank you, Ian. And good afternoon to everyone joining us on the call today. 2021 was a banner year for Mirim and marked a significant turning point for both the company and the Allergy Syndrome community. The Live Marley launch is off to a very strong start as we deliver on our mission to provide life-changing medicines for rare diseases. Today, we will cover our accomplishments to date and our upcoming milestones with some brief prepared remarks, and then take questions. Peter will share some last details, and then Pam will discuss our pipeline. And finally, Ian will touch on a few financial highlights. To start, I would like to remind people of the devastating need for treatment of pruritus and allogeal syndrome. This is the most burdensome effect of cholestasis and allogeal syndrome. It impacts daily life and sleep for patients and families and is a leading indication for liver transplants. the launch of Live Marley has introduced a crucial new treatment for cholestatic pruritus in these patients. Our label and our clinical data show the tremendous potential of Live Marley. And the impact of the long-term data set with six years of treatment experience was recognized last year in the Lancet and with late-breaking presentations of AASLD looking at event-free survival and transplant-free survival. The strength of the Live Marley clinical data and the hard work of our dedicated team is leading to great launch success. We are pleased to report fourth quarter 2021 net product revenue of $3.1 million. And we anticipate the strength to continue throughout the year. Based on what we're seeing so far in 2022, we expect first quarter net product revenue to be at least $8 million and the full year to be at least $50 million. As a reminder, we estimate the overall total opportunity in Allergy Syndrome to be more than $500 million in the U.S. alone. And the early experience in the market confirms our view of this. We have built Merum to be a compelling business based not only on the U.S. opportunity, but with global reach. As the U.S. continues to grow, we expect to see approvals in Europe later this year and in partner markets into 2023. Also, protecting the value we've built in the business Today, we announced the patent grant and U.S. Orange Book listing for Live Marley with coverage into 2040. Building further beyond the Live Marley commercialization, we have an exciting calendar of clinical readouts with data expected across all five of our additional programs over the next two years. And in short, we expect 2022 to be a truly remarkable year for Miriam and the patients we serve. Now, with that, I'll turn it over to Peter, who will provide an update on our Live Marley launch progress.