Harmony Biosciences Holdings, Inc.

Good morning. My name is Todd and I will be your conference operator today. At this time, I would like to welcome everyone to Harmony Biosciences second quarter 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 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 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 in our life cycle, we believe non-GAAP financial results better represent the underlying business performance. Our speakers today on the call are Dr. Jeff Dano, President and CEO, Jeffrey Dirks, Chief Commercial Officer, Dr. Kumar Budur, 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 Dr. Jeffrey Dano. Jeff?

Thank you, Brennan, and thanks, everyone, for joining our conference call today. Q2 was another very productive quarter for the team at Harmony, delivering another quarter of strong revenue growth for WACICs and continued advancement in our late-stage clinical development programs, highlighted by the significant progress made on our next-generation pitocin high dose or Pitocin HD development program, formerly referred to as NG2. During our Q1 earnings call, we shared the initial pilot PK data for the Pitocin Gaster Resistant or Pitocin GR program, formerly referred to as NG1, along with the development plan as the first part of our Pitocin life cycle management activities. This quarter, we are excited to provide an update on our Catolysant HD program with a targeted PDUFA date in 2028 and a provisional patent filed out to 2044, providing us the opportunity to extend the Catolysant franchise to the mid-2040s with durable long-term revenue generation. Let me provide some color regarding the reasons why we are excited about advancing this program because of the unmet medical needs in the narcolepsy community that Pitocin HD is designed to address. Later in the call, Kumar will share some of the initial pilot PK data and a few other details from the Pitocin HD development program. WAKES offers a strong overall benefit-risk profile for patients living with narcolepsy. has brought a meaningful enhancement to the market as the first and only non-scheduled treatment indicated for both excessive daytime sleepiness, or EDS, and cataplexy, and has been extremely successful in the market. But given the nature of narcolepsy as a chronic neurological disorder with difficult-to-treat symptoms, there still remain unmet needs and opportunities for continued innovation. For Pitocin, GR, and HD, the innovation is more focused on the continued unmet needs in the narcolepsy market and what we can do to address those needs. First, we know that greater than 75% of narcolepsy patients experience residual symptoms while on treatment and could benefit from a treatment with greater efficacy. This is why we are pursuing a high-dose Pitocin formulation but also has an optimized PK profile to drive greater efficacy to address this need in the market. Second, about 60% of patients living with narcolepsy experience fatigue, which is a different symptom than EDS and a common symptom in chronic neurological diseases. With a higher dose of pitocin and based on the positive signals that we saw in both EDS and fatigue with pitocin, In our phase two proof-of-concept study in type 1 myotonic dystrophy, or DM1, we plan to pursue a fatigue indication for pitotin HD in patients with narcolepsy as well as other neurological diseases such as DM1. Next, as we explained for our pitotin GR program, a driving force behind the gastro-resistant coding is the fact that about 90% of patients with narcolepsy experience GI symptoms, such as nausea, dyspepsia, and abdominal discomfort. There is a mechanistic rationale for this, especially in patients with NT1 or type 1 narcolepsy, related to the orexin deficiency, since orexin has effects on the vagus nerve in the brain, which is the central controller of gut motility. In addition to the underlying disease mechanism, One out of five patients on narcolepsy medications experience GI side effects related to the common narcolepsy treatments that are used. WAKIX is well tolerated with a low incidence of nausea, but the gastro-resistant coating feature is designed to address the predisposition to GI symptoms in patients with narcolepsy, as well as the GI tolerability issues patients have experienced with other narcolepsy treatments. Taken together, the higher dose, optimized PK profile, gas or resistance feature, and our plan to pursue additional indications would address significant unmet needs in patients with narcolepsy and position Pitocin HD as a meaningfully differentiated product and result in a differentiated label compared to WAKIX. With a provisional patent filed and potential IP out to 2044, and a target to due to date in 2028, this gives us an opportunity to introduce the differentiated product prior to WCAG LOE in 2030 to extend the Pitollison franchise to the mid-2040s and drive durable long-term revenue generation. Our commercial team conducted preliminary market research based on the target product profile for Pitollison HD. and initial results suggest that the features I described to you would be of real interest to patients, be viewed as offering meaningful benefits by healthcare professionals, and perceived as clinically superior compared to WACICS by payers. To round out our sleepwalk franchise, we were very pleased with the FDA approval of WACICS for EDS in pediatric narcolepsy patients ages six years and older And we're excited to launch this new indication into the market on July 1st. As a reminder, the pediatric narcolepsy data, along with data from the ongoing phase three tempo study in Prader-Willi syndrome, keeps us on track toward obtaining pediatric exclusivity and an additional six months of regulatory protection on the back end of our longest patent, which would take us to September 2030. We are on track to submit an SNDA for idiopathic hypersomnia later this year and are very excited about our potential best-in-class orexin-2 agonist program for TPM 1116. We are working with our partner BioPregé and are on track toward filing an IND mid-2025 and then initiating first in human studies second half of 2025. Beyond our strong sleep weight franchise, we are also advancing late stage programs in our other two franchises, neurobehavioral and rare epilepsy. Harmony has expanded its pipeline and diversified its portfolio that now includes three orphan rare CNS franchises, each one of which has peak sales opportunities of $1 to $2 billion. I want to highlight that our pipeline now has eight assets, advancing across 13 development programs, and three of them are in phase three, with a fourth phase three trial to begin later this year. Importantly, this pipeline is poised to deliver at least one new product or indication launch each year over the next five years. This, along with the Tolson HD PDUFA date targeted for 2028, translates into the potential for significant, durable, long-term value creation out beyond 2040. Kumar will be providing you updates on our development programs later in the call. While we advance our pipeline programs, we remain focused on execution across the company and delivered another solid quarter with WCAG's net revenue of $172.8 million representing 29% growth year over year. With these strong results, we are once again reiterating our 2024 net revenue guidance of $700 to $720 million and remain confident that WACIX represents a $1 billion-plus market opportunity in narcolepsy alone, and we are well on our way. What reinforces our confidence in the durability of the WACIX franchise is is the news we shared earlier this morning regarding the WACIX polymorph patent being upheld once again after the second and final attempt to challenge the patent. Late last week, the U.S. Patent and Trademark Office, or USPTO, issued its final denial of the petition for reexamination of the WACIX patent, which was filed by a short seller. We have always stood by WACIX, and our intellectual property. This reexamination request represented the second attempt to challenge the WACIX patent. And in its decision, the USPTO stated, and I quote, this decision is final and non-appealable, end quote. We remain very confident in the strength of our patents. the validity of the patent portfolio, and our ability to rigorously enforce the intellectual property rights protecting WCAG. This bolsters our confidence in the durability of the Pitocin franchise, with the PDUFA date for Pitocin-GR in 2026, the target PDUFA date for Pitocin-HD in 2028, the IP for WCAG-SELFA 2030, and provisional patents filed for Pitocin GR and HD out to 2044. This puts us in a solid position to extend the Pitocin franchise out to the mid-2040s. We also remain active in business development with the goal of building out our pipeline even further. With approximately $434 million in cash, cash equivalents and investments as of June 30th, we are in a solid financial position to execute on additional BD opportunities that are consistent with our growth strategy and offer the potential to drive further value in our overall business. Lastly, we look forward to hosting our inaugural Investor Day on October 1st in New York City, where we will have an opportunity to highlight our robust late-stage pipeline and share some new data with you. With that, I will turn the call over to Jeffrey Dirks, our Chief Commercial Officer, for an update on our commercial performance.