Harmony Biosciences Holdings, Inc.

Good morning. My name is Madison, and I will be your conference operator today. At this time, I would like to welcome everyone to Harmony Bioscience's second quarter 2025 financial results conference call. All participants have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question at that time, please press star 1 on your telephone keypad. Please be advised that today's conference may be recorded. Lastly, if you should require operator assistance, please press star zero. I will now turn the call over to Brennan Doyle, head of investor relations. Please go ahead.

Thank you, operator. Good morning, everyone, and thank you for joining us today as we review Harmony Bioscience's second quarter 2025 financial results and provide a business update. Before we start, I encourage everyone to go to the investor section of our website to find the materials that accompany our discussion today. including a reconciliation of our gap to non-gap financial measures. At this stage of our lifecycle, we believe non-gap financial results better represent the underlying business performance. Our speakers on today's call are Dr. Jeffrey Dano, President and CEO, Adam Zeske, Chief Commercial Officer, Dr. Kumar Padur, Chief Medical and Scientific Officer, and Sandeep Kapadia, Chief Financial Officer and Chief Administrative Officer. As a reminder, we will be making forward-looking statements today, which are based on our current expectations and beliefs. These statements are subject to certain risks and uncertainties. Our actual results may differ materially, and we undertake no obligation to update these statements, even if circumstances change. We encourage you to consult the risk factors referenced in our SEC filings for additional details. I would now like to turn the call over to our CEO, Dr. Jeffrey Dano. Jeff?

Thank you, Brennan. Good morning, everyone, and thank you for joining our call today. I want to begin today's call by reaffirming something we believe is becoming increasingly clear. Harmony Biosciences is a growth story. We have built something rare in our industry, a profitable, self-funding biotech company with an innovative late-stage pipeline poised to deliver meaningful value for both patients and shareholders. Because of this unique profile, we continue to execute from a position of strength. Our foundational business, anchored by Wakex and Narcolepsy, has now delivered another quarter of double-digit revenue growth. We reported $200.5 million in second quarter net revenue, representing a 16% increase year over year. This performance extends our four-year streak of profitability and reinforces WCAG's strong momentum in its sixth year on the market, as reflected by the addition of 400 average patients during the second quarter. WCAG remains the first and only non-scheduled treatment for narcolepsy, leading to broad clinical utility that is meaningful to both patients and prescribers. As demonstrated by the sustained momentum, we believe WCAGX will achieve $1 billion plus blockbuster status in narcolepsy alone, well ahead of loss of exclusivity in 2030. But our story doesn't end with the success of WCAGX, because we are just getting started. What excites us most is what lies ahead. Today, Harmony is a multi-franchise company with three core areas of focus, sleep-wake, neurobehavioral, and rare epilepsies. Each of these franchises includes late-stage development programs with $1 to $2 billion in peak sales potential across multiple indications. Let me walk you through what lies ahead in our pipeline, starting with our next major clinical catalyst coming from our neurobehavioral franchise and its innovative investigational product, ZYN-002. This is a 100% synthetic, pharmaceutically manufactured cannabidiol devoid of THC, delivered through a unique, proprietary, patent-protected, permeation-enhanced, transdermal gel formulation. Our phase three registrational trial in patients with Fragile X syndrome completed enrollment in Q2, and we are on track to report top line data later this quarter. This study, the ReConnect study, was designed to confirm the positive findings of the primary outcome from the Phase 2-3 CONNECT study in the pre-specified group of patients with complete methylation of the FMR1 gene, the underlying genetic defect in patients with Fragile X syndrome. In fact, Fragile X is the most common known inherited cause of intellectual impairment and autism spectrum disorders. Stepping back a moment, in order to understand the potential significance of our Phase III ReConnect study, there are roughly 80,000 people living with Fragile X in the U.S., similar in size to the diagnosed narcolepsy market. However, unlike that market, there are currently no FDA-approved treatments for Fragile X syndrome. A positive readout from the ReConnect study could represent a major breakthrough, the potential for the first and only approved therapy for Fragile X syndrome, and a transformational moment for people living with Fragile X syndrome and their families who have waited far too long for a therapy designed to address their needs. Kumar will be sharing more detail with you on the reasons for our strong conviction in the upcoming top-line data readout. In our sleep-wake franchise, as I mentioned, WAKIT continues to grow, and our pitolicin life-cycle management programs are designed to both expand and extend this franchise well into the mid-2040s. We have major catalysts ahead for the two next-generation formulations of pitolicin, high-dose pitolicin or pitolicin HD, and a gastro-resistant formulation of Pitocin or Pitocin-GR. And we are on track to initiate phase three registrational trials in both narcolepsy and idiopathic hypersomnia with Pitocin-HD in the fourth quarter of this year. We are also advancing a novel orexin-2 agonist with a potentially best-in-class profile. and remain on track to enter the clinic and initiate first in human studies later this year with clinical data anticipated in 2026. Our third franchise in rare epilepsy is also making steady progress. EPX100, or chlamazole hydrochloride, is one of the most advanced 5-HT2 agonist compounds with a well-characterized mechanism of action and a strong safety record. It is now in phase three registrational trials for both Dravet syndrome and Lennis-Gastaut syndrome, with pivotal data expected in 2026. Our commitment to patients with serious rare neurological disorders does not end here. To that end, we recently entered into a research collaboration with CERC Biosciences. a regenerative medicine company discovering novel therapies based on cellular reprogramming and focused on developing novel regenerative cellular therapies to replace and restore function in patients with advanced neurological disorders. Our collaboration with CERC is strategically aligned with our current pipeline and focused on treatments for refractory epilepsy and treatment-resistant narcolepsy. This research could potentially result in the next generation of innovative disease-modifying therapies for these advanced chronic neurological disorders. Sandeep will be commenting further on the terms of this deal. When you look at Harmony today, it should be evident that what we are building is one of the most robust pipelines in the industry for patients with rare neurological disorders. We now have eight innovative assets across 13 development programs, including up to six phase three trials by the end of this year. This pipeline is poised to deliver one or more new product or indication launches every year for the next several years. And with more than $670 million in cash and cash equivalents on the balance sheet, and a disciplined approach to capital deployment, we have the flexibility to continue to strategically expand our pipeline through targeted business development efforts in this favorable environment. So what does all this mean? It means that in an industry where sustainable success remains elusive, Harmony has built something different and something unique, a commercially durable business with a robust late-stage pipeline and a clear path to delivering long-term value for patients, providers, and shareholders alike. And that's what makes Harmony one of the most compelling growth stories in biotech today. With that, I'll turn the call over to Adam Zeske, our Chief Commercial Officer, for an update on our commercial performance.