5/6/2026

speaker
Tracy
Operator

Good afternoon and welcome to Merum Pharmaceuticals' first quarter 2026 earnings conference call. My name is Tracy and I will be your operator today. All lines are currently in a listen-only mode and there will be an opportunity for Q&A after management's prepared remarks. If you would like to ask a question during that time, press star 1 to raise your hand. I would now like to hand the call, the conference over to Andrew McKibben, SVP of Strategic Finance and Investor Relations. Please go ahead.

speaker
Andrew McKibben
SVP of Strategic Finance and Investor Relations

Thank you, Tracy, and good afternoon, everyone. I'd like to welcome you to Miriam Pharmaceuticals' first quarter 2026 earnings conference call. For our prepared remarks, I'm joined today by our Chief Executive Officer, Chris Peets, our President and Chief Operating Officer, Peter Radovich, and Eric Bierkhold, our Chief Financial Officer. Our chief medical officer, Joanne Kwan, will be joining us for Q&A. Earlier this afternoon, Merim issued a press release reporting our first quarter 2026 financial results. Copies of the press release and our SEC filings are available in the investor 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 Merim's programs and market opportunities for its approved medicines and product candidates and financial guidance. 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 about these risks and uncertainties. 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. We have a number of important updates to cover today. But I'd like to start by grounding in the vision we set when we founded Merriman 2018, building a company focused on bringing forward medicines for overlooked rare diseases. This quarter reflects the progress we've made in turning that vision into a durable, growing business. Our start was based on Liv Marley, and today we are a broader rare disease company with three approved medicines and a pipeline position to deliver multiple new therapies over the next two years. These high-impact programs are grouped across two focus areas. rare liver disease, where we have built clear leadership, and rare genetic disease, where we are establishing a second growth platform, each with distinct commercial capabilities. Across both, we've built a financially self-sustaining business that can support continued investment in the portfolio. Our strategy is driving compelling results. Starting with rare liver disease, uptake of Live Marley remains strong, driven in part by performance in PFIC, which continues to exceed expectations. Based on that demand and continued performance across all brands, we are raising our full-year revenue guidance to $660 to $680 million. More importantly, we are now seeing the next phase of our rare liver disease business take shape. Our recent clinical readouts in PSC and hepatitis delta represent important potential expansions for this business, extending beyond our pediatric foundation into larger patient populations with significant unmet needs. In PSC, the VISTA study of velixibat showed a significant improvement in pruritus, reinforcing the potential for velixibat to play an important role for these patients who currently have no approved medicines. This is a major advance in PSC research and positions velixibat as a potential first approved medicine for patients in the U.S. And in hepatitis delta, results from the Phase IIb portion of the ZER1 study further support the potential for brelovotug in a patient population where treatment options are extremely limited. We look forward to the upcoming late-breaking presentations for both Vistos and Azure at EASL later this month. Now, in parallel to this expansion of our rare liver disease business, today we are announcing another step in building out our rare genetic disease business with the addition of Zolurgocertib, recently licensed from Insight. Zolurgocertib is a once-daily oral ALK2 inhibitor in development for fibrodysplasia ossificans progressiva, or FOP. an ultra-rare progressive condition where patients develop bone and soft tissues. This accumulation of excess bone leads to profound physical immobilization, with most FOP patients becoming wheelchair-dependent by early adulthood and severely impacts life expectancy. Based on the strength of Zolurgicertib's progress study conducted by Insight, an NDA has been accepted with priority review with a PDUFA date of September 26th this year. If approved, we expect to launch by year-end. This is a strong strategic fit aligning with our capabilities in rare genetic disease where care is concentrated in a small number of specialized centers and requires deep engagement with patients, caregivers, and physicians. Stepping back, we've built a company with multiple commercial growth drivers, a pipeline of meaningful upcoming catalysts, and the financial strength to advance our portfolio independently. This foundation is translating directly into high-impact medicines for patients, and into value creation as we deliver on our strategy. And with that, I'll turn the call over to Peter to walk through the commercial portfolio and preparation for the three upcoming central launches. Peter?

Disclaimer

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