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8/6/2025
Hello, everyone, and welcome to the Neuron Pharmaceuticals Report Second Quarter 2025 Financial Results and Provide Business Update. My name is Carla, and I will be coordinating your call today. During the presentation, you can register to ask questions by pressing star followed by 1 on your telephone keypad. If you change your mind, please press star followed by 2. I would now like to hand you over to your host, Andrew McKeegan, SVP of Strategies strategic, finance, and investor relations to begin. Please go ahead when you're ready.
Thanks, Carla, and good afternoon, everyone. I'd like to welcome you to Miriam Pharmaceutical's second quarter 2025 conference call. I'm joined today by our CEO, Chris Peets, our President and Chief Operating Officer, Peter Radovich, our Chief Medical Officer, Joanne Kwan, and Eric Bjerkel, our Chief Financial Officer. Earlier today, Miriam issued a news release announcing the company's results for the second quarter 2025. Copies of this news release and SEC filings can be found in the Investors section of our website. Before we start, I'd like to remind you that during the course of this conference call, we'll be making certain forward-looking statements based on management's current expectations, including statements regarding Merrim's programs and market opportunities for its approved medicines and product candidates. These statements represent our judgment and knowledge of events as of today and inherently involve risks and uncertainties that may cause actual results to differ materially from the results discussed. We are under no duty to update these statements. Please refer to the risk factors in our latest form 10Q and subsequent SEP filings for more information. With that said, I'd like to turn the call over to Chris.
Chris? Thanks, Andrew, and good afternoon, everyone. 2025 is shaping up to be another outstanding year for Barron, the second quarter that underscores the momentum behind both our commercial medicines and our pipeline. Barron was founded in 2018 with a vision of bringing life-changing medicines to patients with rare disease around the world. Today, we have three approved medicines with reimbursed patients in over 30 countries, a pipeline that is rapidly advancing opportunities in still larger settings, highlighted by three potentially pivotal studies reading out over the next 24 months. Our strategy is rooted in commercial execution, scientific innovation, and financial discipline, and we're proud of the continued progress on all three fronts that we will cover today. On that note, on second quarter results, we're excited to share another strong update premiering with total revenues reaching $128 million, or 64% growth over the second quarter last year. But Marley is a key driver of these results and is continuing to bring substantial benefits to patients and to build a differentiated position with physicians. As the top line suggests, we are reaching more patients than we initially anticipated. Given the growth we are seeing across our medicines, we are raising our full year of guidance for 2025 to be $490 to $510 million. positioning us for another year of close to 50% top-line growth. Turning to the pipeline, the progress we are making is setting the stage for an exciting 2026, where we have a clear path to three late-stage milestones. In particular, the VISTA's Phase 2B study and primary sclerosynchronegitis, PFC, is on track to complete enrollment this quarter, with top-line data expected in the second quarter next year. Now, this program passed its interim analysis last year, and the consistent precedent data for IDOT inhibition across other cholestatic settings gives us confidence in the potential of felixidat and PFC. Exciting steps lie ahead to potentially bring this much-needed treatment to PFC patients. We're also seeing excellent momentum in our VantagePVC and EXPAND studies and are looking forward to starting our Phase II study of MRN3379 and fragile X syndrome now that we have FDA feedback on the program, which Joanne will tell you more about shortly. I would also like to say congratulations Thank you to the Miriam team, whose dedication to bringing high-impact medicines to patients has made all this progress possible. I'm proud of how this group has come together to create a high-growth, cash-flow-positive rare disease leader with an exciting pipeline. And with that, I'll hand the call over to Peter to walk through the commercial performance in more detail.
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