Harmony Biosciences Holdings, Inc.

Good morning, everyone. My name is Beau, and I will be your conference operator today. At this time, I would like to welcome everyone to Harmony Bioscience's fourth quarter and full year 2024 financial results conference call. All participant lines 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 one on your telephone keypad. Please be advised that today's conference is being recorded. Lastly, if you should require operator assistance, please press star zero at any time. I will now turn the call over to Mr. Brendan Doyle, head of investor relations. Please go ahead, sir.

Brendan Doyle Thank you, operator. Good morning, everyone, and thank you for joining us today as we review Harmony Bioscience's fourth quarter and full year 2024 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 GAAP to non-GAAP financial measures. At this stage of our lifecycle, we believe non-GAAP financial results better represent the underlying business performance. Our speakers on today's call are Dr. Jeffrey Dano, President and CEO, Jeffrey Dirks, Chief Commercial Officer, Dr. Kumar Badur, 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 Dato.

Jeff? Thank you, Brennan. Good morning, everyone, and thank you for joining our call today. 2024 was a year of strong execution and meaningful progress for Harmony Biosciences. We continue to strengthen our leadership position in SleepWake while advancing and expanding one of the most robust late-stage CNS pipelines in the industry. Beginning at our investor day last October, we outlined a clear path toward becoming the leading CNS company focused on developing and delivering innovative treatments for patients with unmet medical needs. That path includes advancing our late-stage pipeline to deliver one or more new product or indication launches each year over the coming years. We remain committed to delivering on our promise to patients while generating long-term, durable value creation for shareholders. In fact, our current pipeline, if successful, is poised to deliver over $3 billion in net revenue going forward. 2024 was also a year of exceptional growth in both our commercial business and in our pipeline through strategic acquisitions. Our net product revenues in 2024 were $714.7 million, representing 23% growth year over year. In Q4 alone, we generated $201.3 million in net revenue. This momentum is reflective of the continued durable growth of WAKIX in narcolepsy based on its broad clinical utility and differentiated profile. as the first and only FDA-approved once-daily non-scheduled treatment for narcolepsy and our proven commercial execution. We remain confident in WCAGS being a billion-dollar-plus opportunity in narcolepsy alone, and we are on our way to achieving that milestone well before WCAGS-LOE in 2030. On that topic, Today, we are also announcing our first generic settlement agreement with Novagen Pharma, resolving the patent infringement litigation related to Novagen's abbreviated new drug application for a generic version of pitolicin hydrochloride. As part of the agreement, Novagen will have a license to sell its generic product beginning January 2030 or earlier under certain circumstances. In addition, we are on track in pursuit of obtaining pediatric exclusivity for Ptolemy, which, if granted, would add an additional six months of regulatory exclusivity. This settlement reinforces the strength and durability of Harmony's intellectual property portfolio. As you can see, we remain committed to vigorously defending our intellectual property estate. Commercial Engine has allowed us to finance our growing pipeline from our balance sheet as a profitable, self-funding biotech company. Harmony was founded on our leadership in sleep-wake, and our pipeline is now made up of three orphan rare neurology franchises, each with potential peak sales opportunities of $1 billion to $2 billion each. Before turning to the opportunities ahead of us in 2025, I want to address the recent update on our supplemental new drug application for Pitocin in idiopathic hypersomnia, or IH. While we recognize the challenges with this submission, given that the Phase III in-tune study did not meet the primary endpoint during the four-week randomized withdrawal phase, we made the decision to submit the SMDA for Pitocin in IH based on the following three factors. First, the overall benefit-risk profile of pitocin in IH based on the totality of the data. Second, the unmet medical need in IH based on limited treatment options. And third, our deep commitment to the IH patient community. In fact, the Hypersomnia Foundation and more than 650 members of the IH community signed a petition to the FDA requesting a review of the Pitocin SNDA file for IH, citing the burden of disease and significant lack of treatment options, especially ones that are non-scheduled. While this outcome is not what we had hoped for, it is only a short-term setback that in no way affects the progress we are making toward our strategic priorities. In fact, 2025 is shaping up to be a transformational year for Harmony. This is a pivotal moment in our growth story, one where we are advancing important late-stage programs poised to deliver key clinical milestones and reinforce our leadership in sleep-wake and rare CNS disorders. Our long-term vision has always been to extend our leadership in sleep-wake through the development of Pitocin high dose or Pitocin HD and enhanced higher dose formulation of Pitocin designed to deliver an optimized PK profile and therapeutic benefits. Kumar will share more about our development plans for our next generation Pitocin formulations But what I want you to take away is that this program is the result of patient-focused drug development. These formulations are designed to build on the innovation of Pitocin as a first-in-class molecule with a novel mechanism of action while addressing some of the most common unmet needs in people living with narcolepsy and idiopathic hypersomnia. In addition to demonstrating enhanced efficacy for excessive daytime sleepiness, The Phase III registrational trials for Pitocin HD, both set to initiate in Q4 2025, will also evaluate the common symptom of fatigue in the narcolepsy trial and the very common and burdensome symptom of sleep inertia in the IH trial. With top-line data anticipated in 2027 toward PDUFA dates for both narcolepsy and IH in 2028, along with a provisional patent extending to 2044, the Tolleson HD is the foundation of our long-term growth strategy and path toward durable long-term value creation. Beyond sleep-wake, 2025 will bring another major milestone with the top-line data readout from our Phase III Registrational Trial of ZYN002 in Fragile X Syndrome, the ReConnect Study. in the third quarter. This study was designed to confirm the positive findings from the pre-specified analysis of patients with complete methylation in the Phase 2-3 CONNECT study and, if positive, could put us on a path toward bringing the first approved treatment for Fragile X syndrome to patients and their families. Importantly, we possess global rights to ZYN-002. which provides us an opportunity to expand access worldwide if successful. And that is just the beginning. Kumar will share more details with you on our Fragile X program, as well as the exciting work we are doing in 2025 to advance our innovative rare epilepsy franchise with EPX100, the most advanced 5-HT2 agonist clinical development program in the clinic. With registrational trials in both Gervais syndrome and Lennox-Gastaut syndrome, we are building a rare epilepsy franchise with the potential to have a meaningful impact on the lives of these patients, with plans to go broader in the developmental and epileptic encephalopathy space. Based on our strong foundation of commercial success with WAKIX, we have been very busy over the past two years building out our pipeline, and we are just getting started. The acquisitions we did were thoughtful and strategic, leading to our three Orphan Rare CNS franchises. And we remain actively engaged in identifying and evaluating additional opportunities that could expand our leadership in sleep-wake, neurobehavioral disorders, or rare epilepsies, and other seizure disorders. With over $576 million in cash and cash equivalents in the balance sheet, we are in a solid position to deploy our resources to expand our pipeline and create meaningful value for patients and shareholders alike. As you can see, these upcoming catalysts underscore why 2025 is shaping up to be a transformational year for Harmony. Harmony is a growth story built for long-term success with a market-leading sleep-like franchise, a robust late-stage pipeline, and the experience and strategic ability to navigate short-term challenges that make us stronger and even more committed to our long-term mission to develop and deliver innovative therapies for patients living with rare neurological diseases. When we deliver on our promise to patients, we generate long-term, durable value creation for our shareholders. Thank you, and I will now turn the call over to Jeffrey Dirks, our Chief Commercial Officer, to give you an update on our commercial performance. Jeff?