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 the Harmony Biosciences Second Quarter Financial Results Conference Call. All participant lines have been placed on mute to prevent any background noise. After the speaker's prepared 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. Please be advised that today's conference is being recorded. And lastly, if you should require operator assistance today, please press star zero. I would now like to turn the call over to Mr. Brennan Doyle, Head of Investor Relations. Please go ahead, sir.

Good morning, everyone, and thank you for joining us today as we review Harmony Biosciences' second quarter 2026 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 today's discussion, including a reconciliation of our GAAP to non-GAAP financial measures. At this stage of our life cycle, we believe non-GAAP financial results better represent the underlying business performance. Our speakers on today's call are Dr. Jeffrey Dayno, President and CEO, , Adam Zaeske, Chief Commercial Officer, Dr. Kumar Budur, Chief Medical and Scientific Officer, Peter Anastasiou, Chief Operating Officer, and Steve Molichella, Interim Principal Financial 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 Dayno. Jeff.

Thank you, Brennan. Good morning, everyone, and thank you for joining us today. This was a defining quarter for Harmony Biosciences on two fronts. Commercially, WCAG delivered record quarterly net revenue of $261.3 million up 30% year-over-year and up 21% compared to last quarter, signaling a decisive rebound from the seasonal headwinds we discussed on our first quarter earnings call. And importantly, on the R&D front related to our robust pipeline, today we shared encouraging data from a Phase I single ascending dose, or SAD, study for BP205, that reinforces its potential as a best-in-class orexin-2 receptor agonist. Revenue is on track to exceed $1 billion this year, and our opportunity with our orexin-2 agonist BP205 is coming into focus with multiple data catalysts over the next six months. The two key messages that I want you to take away from today's call are, first, continued strong growth for WCAG on track for over $1 billion in net revenue for the year. And second, encouraging phase one PK data for our potential best-in-class orexin-2 agonist BP205 with multiple data catalysts coming in the next six months. The foundation upon which we continue to grow the business and advance our pipeline remains strong. We are a profitable, self-funding biotech company Operating from a position of strength, a proven commercial engine now in its seventh year on the market, a robust pipeline centered around BP205, our potential best-in-class orexin-2 agonist, a balance sheet with the capacity, and a management team with the expertise and conviction to execute on meaningful business development opportunities. and a multi-layered IP strategy to protect the Patolicent franchise out to 2030. We continue to run the business aligned around our four priorities focused on value creation, growing the Wacons franchise in an evolving market, advancing our robust pipeline, transacting on strategic business development opportunities and protecting our IP estate around the Patolicent franchise. Let me walk you through the highlights for each of these four priorities. First, the commercial performance this quarter was outstanding as we continue to grow the WCAG franchise in an evolving market. Our record quarterly revenue of $261.3 million keeps us firmly on track to achieve more than $1 billion in net revenue in 2026. which is why we are confident in reiterating our full year guidance of $1 to $1.04 billion. WACICS has a compounded annual growth rate of about 40% over the last five years and there continues to be a large market opportunity for WACICS with about 80,000 patients diagnosed with narcolepsy and another 90 to 100,000 individuals not yet diagnosed. Turning to our pipeline and the focal point for this call, BP205, our potential best-in-class orexin-2 agonist. Today, we shared encouraging data from a Phase I single ascending dose PK study for BP205. Kumar will take you through the SAD data results later in the call. At a high level, BP205 is designed to deliver a differentiated profile as the most potent of the orexin-2 agonists currently in the clinic with excellent selectivity and now with clinical PK data demonstrating a predictable PK profile with the potential for once daily dosing along with a favorable safety tolerability profile. These data strengthen our conviction that BP205 could be a best-in-class erection 2 agonist and reinforce our commitment to invest in the BP205 development program. We will be initiating phase 2 trials the middle of next year to evaluate multiple CNS indications as we believe BP205 could have broad clinical utility. Next up for BP205, is top-line data from the Multiple Ascending Dose Study in Q4 and initiation of the Phase 1b study in sleep-deprived healthy volunteers in the third quarter with top-line data readout expected early next year. Kumar will provide more color on BP205 during his R&D update. One additional comment on BP205 and our exciting orexin opportunity. We have been leaders in the sleep lake space for almost a decade now and are leveraging our expertise to accelerate our BP205 development program toward multiple CNS indications and become a leader in the erection space. In addition to organic growth, we have significant firepower to put toward business development for inorganic growth. With approximately $963 million in the balance sheet, We have the capacity and the conviction to execute on meaningful transactions to drive long-term value. Peter will share more color around our BD strategy later in the call. Additionally, he will provide an update on our multi-layered IP strategy and our efforts to protect the Wacus franchise. We have settled with six of the seven ANDA filers and are confident in the strength of our IP estate which supports WCAGS exclusivity to March of 2030, inclusive of six months of pediatric exclusivity for which we are on track to obtain. In summary, this has been a defining quarter for Harmony Biosciences. We posted record revenue for WCAGS in its seventh year on the market and shared encouraging data for BP205 which supports its profile as a potential best-in-class orexin-2 agonist. With multiple data catalysts coming for BP205 over the next six months and our focus on business development, Harmony is poised to deliver meaningful long-term value creation as we drive toward delivering innovative treatments for patients living with CNS diseases and unmet medical needs. With that, I will now turn the call over to Adam Zaeske, our Chief Commercial Officer, for a closer look at our Q2 commercial performance.