Mirum Pharmaceuticals, Inc.

And thank you all for joining. I would like to welcome you all to the Miriam Pharmacute Calls Report, Second Quarter 2023 Financial Results and Provides Business Update. My name is Brica and I'll be your moderator for today's call. 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 turn the call over to Andrew McGibbon, VP of Investor Relations and Finance. So, Andrew, please go ahead.

Thanks, Brika, and good afternoon, everyone. I'd like to welcome you to Miriam Pharmaceutical's second quarter 2023 conference call. I'm joined today by our President and CEO, Chris Peets, our Chief Operating Officer, Peter Radovich, and our Head of Research and Development, Pam Vick. Earlier today, Merim issued a news release announcing the company's results for the second quarter of 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. 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 Merim. Our pending acquisition of Travere's bile acid product portfolio and our program is based on management's current expectations. including statements regarding Miriam's current and future business and commercial plans, development programs, regulatory expectations, 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 filings with the SEC. With that said, I'll turn the call over to Chris. Chris?

Thank you, Andrew. And good afternoon to everyone joining us on the call today. We are thrilled to discuss yet another quarter of strong growth at Neuron. We are on track to become a leading multi-product franchise in pediatric hepatology through the impact of Live Marley for patients globally, continued progress of the Lixabat in the clinic, and the pending acquisition of Kinadol and Colbom. The last quarter saw substantial progress on our five-part strategy, which is to grow Live Marley in the U.S., launch Livmarly in international markets, establish new indications for Livmarly, advance and commercialize Elixabat and adult cholestatic indications, and acquire additional high-impact medicines for rare disease. We've made great strides on all of these areas of strategic focus so far this year. First, on growing Livmarly's commercial business, in the second quarter, We performed well against our guidance of 50% year-over-year net product sales growth in the U.S. in 2023, as well as growth from international markets, achieving $32.5 million of Live Marley revenue and $37.5 million total revenue. We are also excited about the recent progress in international markets with our approval in Canada and a growing list of countries selling Live Marley in distributor markets. Livmarly indication expansion efforts are also making great progress with our PFIC application under review with the December 13th, 2023 PDUFA date. We're looking forward to the potential label expansion based on the compelling March phase three data and bringing Livmarly to PFIC patients. In addition, the Embark biliary atresia study is fully enrolled, heading towards top line data later this year. Elixabat is also progressing nicely towards interim analyses in PSC and PBC later this year. positioning those studies to expand into their potentially registrational portions. And finally, on the fifth strategic pillar of product acquisition, we are advancing towards closing the acquisition of Kinadol and Colbomb, two commercial products with over an aggregate of $100 million of annual net sales in 2022. As we've shared recently, we expect this acquisition to deepen our leadership in pediatric hepatology and accelerate our growth across our product line. We expect the transaction to close in the third quarter and are excited about the fit of these bile acid replacement medicines with Marley and the upcoming phase three readout for Keenadol and CTX. Financially, we are well positioned to execute on our strategy. We ended the second quarter with a $330 million cash balance and Q2 was another quarter of financial growth with relatively steady operating expense levels and a growing top line compared to the first quarter. The pending addition of Kinadol and Kolbam offers an opportunity to further accelerate our revenue with a highly synergistic business. Concurrent to this pending acquisition, we entered a private placement agreement for $210 million supported by several existing and new investors, which we'll use to fund the upfront payment in connection with the acquisition. This financing allows us to maintain the strength of our balance sheet and positions us for continued growth. With that, I'll pass the call over to Peter to discuss our commercial business in more detail before Pam gives an R&D update.