Rhythm Pharmaceuticals, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the Rhythm Pharmaceuticals first quarter 2026 earnings conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the session, you will need to press star 11 on your telephone, and you will then hear an automated message of ads, and your hand is raised. And to withdraw your question, please press star 1-1 again. Please be advised that today's conference is being recorded. I would like now to turn the conference over to Dave Connolly. Please go ahead.

Thank you, Michelle. I'm Dave Connolly here at Rhythm Pharmaceuticals. For those of you participating on the conference call, our slides can be accessed and controlled by going to the investor section of our website, ir.rhythmtx.com. This morning, we should have a press release that provides first quarter 2026 financial results and a business update, and that press release is available on our website. Our agenda is listed on slide two. On the call today are David Meager, Chairman, Chief Executive Officer and President, Jennifer Lee, Executive Vice President, Head of North America, Hunter Smith, Chief Financial Officer, and Jan Mazzebro, Executive Vice President, Head of International, is on the line joining us from Europe. On slide 3, I'll remind you that this call contains remarks concerning future expectations, plans, and prospects, which constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in our most recent annual or quarterly reports on file with the SEC. In addition, any forward-looking statements represent our views as of today and should not be relied upon as representing our views as of any subsequent dates. We specifically disclaim any obligation to update such statements. With that, I'll turn the call over to David Meeker, who will begin on slide five.

Thank you, Dave. Good morning, and thank you for joining. So we had another good quarter. Now, before we dive into some of the more recent events, I do want to highlight the ongoing progress in our base business, predominantly VBS. Revenues for the quarter were $60 million. As we would expect with an ultra-rare disease, awareness of the disease continues to grow, leading to more patients diagnosed or potential candidates for therapy. We have learned much through this initial launch, and we continue to adapt and optimize use of available data to connect with the right healthcare providers who may have a BBS patient. There is still more long-term opportunity to unlock with BBS. With the FDA approval of Incivri for acquired HO on our Perdufidate and European marketing authorization, which came early, we have expanded our focus. As with the BBS launch, our plan will be to share a view of the early launch metrics with a goal of giving you a sense of how it is working, with the usual caveat that it is extremely early. That said, we are pleased with a strong start with more than 150 start forms to date and a good reception at the payer level. Jennifer will provide more details. Slide six is to remind you again of the significant opportunity in HO with an estimated prevalence of 10,000 patients in the US and Europe and 5,000 to 8,000 patients in Japan. And with a much more concentrated call point than BBS, this is a meaningfully larger opportunity. Japan is positioned to be the second largest opportunity for HO behind the US. As we have shared, we have been extremely appreciative of the highly collaborative, encouraging nature of our interactions with the Japanese regulatory authority, the PMDA. All Japanese patients have completed the 12-month trial, eight patients on treatment, and four on placebo. One patient discontinued early, secondary to hyperpigmentation. Slide seven shows the BMI change as compared to the values for the full 142 patients. As you can see from the results, the results were similar to the full cohort. The placebo-adjusted differences were slightly less, mostly due, or due in part, at least to the fact that the placebo group did not gain weight in the same way their Western counterparts did. Although the numbers are small, this may reflect the cultural differences with a more obesity-prone environment in the West. The team has moved rapidly to complete the filing, putting us in the position of an anticipated approval before the end of the year. The Japanese team is fully in place, and Jan will talk more about the opportunity and the organizational build. Finally, as we have previously shared, we look forward to a number of milestones this year. Pending late-breaking abstract acceptance, our goal is to share Dr. Miller's six-month data in PWS at the ENDO meeting in June. Similar to what was presented in December, we would expect to share BMI data, HQCT data, and DEXA scan data for those patients who have completed the scans. We anticipate sharing 718 data mid-year, and we are targeting the Q2 earnings call, at which time we would share the Part C results in HO, and potentially the available data in PWS. CMC work and BIVA bioequivalent studies for the new formulation are underway with a goal of being in a position to start the Phase III trial with BIVA-Melegon in HO by the end of 2026. I will now turn the call over to Jennifer.