11/4/2025

speaker
Harry
Operator

Hello and welcome to the Mirim Pharmaceutical third quarter 2025 financial results and business update. My name is Harry and I'll be your operator today. All lines are currently in listen-only mode and there'll be an opportunity for Q&A after management's prepared remarks. To enter the queue for questions, please press star followed by one on your telephone keypad. I would now like to hand the conference over to Andrew McKibbin, SVP of Strategic Finance and Investor Relations. Please go ahead.

speaker
Andrew McKibbin
SVP of Strategic Finance and Investor Relations

Thanks, Harry, and good afternoon, everyone. I'd like to welcome you to Miriam Pharmaceuticals' third 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 Bierkle, our Chief Financial Officer. Earlier today, Miriam issued a news release announcing the company's results for the third 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 will be making certain forward-looking statements based on management's current expectations, including statements regarding Miriam'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 10-Q and subsequent SEC filings for more information. With that said, I'd like to turn the call over to Chris. Chris?

speaker
Chris Peets
Chief Executive Officer

Thanks, Andrew, and good afternoon, everyone. 2025 continues to be an outstanding year for MIRA. We've created a leading rare disease company, purpose-built to create and deliver life-changing medicines to patients. Our success comes from that foundation, a team deeply connected to patients and families, turning their insights into meaningful therapies and measurable performance. In the third quarter, we delivered strong commercial results, advanced our clinical pipeline, and strengthened our financial foundation. I'm proud of the way our team continues to execute with focus and consistency. First, on commercial performance, we reported third quarter revenue of $133 million, representing a nearly 50% year-over-year increase over the same period last year. This performance reflects the strength and breadth of our commercial portfolio, including continued momentum from the US PFIC launch and expanding demand from our international markets. Turning to R&D, we remain on track for three potentially pivotal readouts over the next 18 months. First up is the VISTA's Phase IIb study in PFC. With enrollment complete, we expect to announce top-line data in the second quarter of 2026. With a successful interim analysis last year and a consistent body of supporting data with IVAT inhibitors across multiple cholestatic diseases, We're optimistic about Elixabat's potential to become the first approved treatment in this setting. We're also progressing well with our Vantage study of Elixabat and PDC, the Expand study of Lithmarly and ultra-rare cholestatic conditions, and our newly initiated Phase II study of MRM3379 and Fragile X syndrome. We've also taken meaningful steps to further strengthen our financial performance. This quarter, our cash balance grew significantly, and we recognized positive net income for the first time. This is an important milestone that highlights the operating leverage in our commercial model. It's been another solid quarter of execution for Merum. I want to thank the entire Merum team for their continued dedication to patients. We built a high-growth, cash flow positive rare disease company with a broad pipeline and global footprint, and we're just getting started. And with that, I'll hand the call over to Peter.

Disclaimer

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