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Harmony Biosciences Holdings, Inc. (HRMY) Presents at 25th Annual Needham Virtual Healthcare Conference Transcript

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Harmony Biosciences projects WAKIX, its narcolepsy drug, will surpass $1 billion in annual revenue in 2026—its sixth year on the market—solidifying its position as a blockbuster treatment. The company plans to submit a New Drug Application (NDA) for pitolisant GR, a gastro-resistant next-gen formulation, this quarter, with a potential FDA decision expected in early 2027. CEO Jeffrey Dayno highlighted near-term growth drivers, including expanded indications for pitolisant and commercial strategies to maximize WAKIX’s market dominance. Chief Medical Officer Kumar Budur emphasized ongoing R&D, including pipeline programs targeting sleep-wake disorders beyond narcolepsy, aiming to diversify Harmony’s portfolio. Executives outlined long-term value creation through franchise expansion, regulatory milestones, and strategic commercial execution during the 25th Annual Needham Healthcare Conference.
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SA Transcripts159.3K FollowersFollow5ShareSaveCommentsPlay Earnings CallPlay Earnings Call Harmony Biosciences Holdings, Inc. (HRMY) 25th Annual Needham Virtual Healthcare Conference April 13, 2026 9:30 AM EDT Company Participants Jeffrey Dayno - President, CEO & DirectorAdam Zaeske - Executive VP & Chief Commercial OfficerKumar Budur - Executive VP and Chief Medical & Scientific Officer Conference Call Participants Ami Fadia - Needham & Company, LLC, Research Division Presentation Ami FadiaNeedham & Company, LLC, Research Division Good morning, everyone. I'm Ami Fadia, biotech analyst here at Needham. It's my pleasure to be hosting the Harmony Bioscience team today. I have with me Jeff Dayno, who's the CEO of the company; along with Kumar Budur, Chief Scientific Officer; and Adam Zaeske, Chief Commercial Officer. Thanks, all 3 of you for taking the time to be with us today. Question-and-Answer Session Ami FadiaNeedham & Company, LLC, Research Division Maybe if I could ask Jeff, if you could kick us off with some opening remarks, some priorities for this year, and then we can take it from there? Jeffrey DaynoPresident, CEO & Director Yes. Sure, Ami. Yes, Ami. And on behalf of the Harmony team, thank you once again for the invitation to Needham's Virtual Healthcare Conference. And we are very excited for what is coming this year, that sets us up for both near-term and long-term growth and value creation. As for some of our key priorities, just to sort of walk through, starting with WAKIX. So we are on track to achieve over $1 billion in net revenue for WAKIX in its sixth year on the market, which provides us with a very solid foundation, I think, as many are aware. In our pitolisant next-gen programs, pitolisant GR gastro-resistant is on track for NDA submission this quarter to extend the pitolisant franchise with a target PDUFA date in the first

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