Harmony Biosciences Holdings, Inc. Common Stock 2026 Q2 Earnings Call

Please go ahead, sir. Good morning, everyone, 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 Chief Executive Officer, Adam Zaeske, Chief Commercial Officer, Dr. Kumar Budur, Chief Medical and Scientific Officer, Peter Anastasiou, Chief Operating Officer, and Stephen Mollichella, 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, 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, thank you for joining us today.

This was a defining quarter for Harmony Biosciences on two fronts. Commercially, WAKIX delivered record quarterly net revenue of $261.3 million, up 30% year-over-year, up 21% compared to last quarter, signaling a decisive rebound from the seasonal headwinds we discussed on our first quarter earnings call. Importantly, on the R&D front related to our robust pipeline, today we shared encouraging data from a phase I single ascending dose (SAD) study for BP-205 that reinforces its potential as a best-in-class orexin-2 receptor agonist. Revenue is on track to exceed $1 billion this year, our opportunity with our orexin-2 agonist BP-205 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 WAKIX on track for over $1 billion in net revenue for the year. Second, encouraging phase I PK data for our potential best-in-class orexin-2 agonist BP-205 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 BP-205, 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. A multilayered IP strategy to protect the pitolisant franchise out to 2030.

We continue to run the business aligned around our four priorities focused on value creation, growing the WAKIX franchise in an evolving market, advancing our robust pipeline, transacting on strategic business development opportunities, and protecting our IP estate around pitolisant 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 WAKIX 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 billion-$1.04 billion.

WAKIX has a compounded annual growth rate of about 40% over the last five years. There continues to be a large market opportunity for WAKIX with about 80,000 patients diagnosed with narcolepsy and another 90,000 to 100,000 individuals not yet diagnosed. Turning to our pipeline and the focal point for this call, BP-205, our potential best-in-class orexin-2 agonist. Today, we shared encouraging data from a phase I single ascending dose PK study for BP-205. Kumar will take you through the SAD data results later in the call. At a high level, BP-205 is designed to deliver a differentiated profile as the most potent of the orexin-2 agonists currently in the clinic with excellent selectivity 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 BP-205 could be a best-in-class orexin-2 agonist and reinforce our commitment to invest in the BP-205 development program. We will be initiating phase II trials the middle of next year to evaluate multiple CNS indications as we believe BP-205 could have broad clinical utility. Next up for BP-205 is top-line data from the multiple ascending dose study in Q4. Initiation of a phase I-B 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 BP-205 during his R&D update. One additional comment on BP-205 and our exciting orexin opportunity. We have been leaders in the sleep-wake space for almost a decade now and are leveraging our expertise to accelerate our BP-205 development program toward multiple CNS indications and become a leader in the orexin space.

In addition to organic growth, we have significant firepower to put toward business development for inorganic growth. With approximately $963 million on 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 multilayered IP strategy and our efforts to protect the WAKIX franchise. We have settled with six of the seven ANDA filers and are confident in the strength of our IP estate, which supports WAKIX 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 WAKIX in its seventh year on the market and shared encouraging data for BP-205, which supports its profile as a potential best-in-class orexin-2 agonist. With multiple data catalysts coming for BP-205 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.

Adam? Thank you, Jeffrey, good morning, everyone.

The second quarter continued our strong growth and momentum trend. WAKIX delivered $261.3 million in net sales, up 30% year-over-year, and up 21% over the first quarter. Now in its seventh year on the market and firmly on pace for our full year guidance of $1 billion to $1.04 billion in net revenue. Last quarter, we saw a bit more pronounced seasonal market access headwinds that impact the industry every year. The elevated plan changes, plan switching, and premium increases, which can delay patient starts, especially in January. The underlying fundamentals remained steady and consistent. This quarter, the demand-driven trajectory and patient additions continued. WAKIX achieved estimated average patients of 8,950, or an increase of approximately 450 patients from 1Q.