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 third 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 Matthew Beck. Please go ahead.

Thank you, operator. Good morning, everyone, and thank you for joining us today as we review Harmony Bioscience's third 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 the 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 Dano, President and CEO, Adam Zeske, Chief Commercial Officer, Dr. Kumar Budur, Chief Medical and Scientific Officer, and Sandeep Kapadia, Chief Financial and 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 Dana. Jeff?

Thank you, Matt. Good morning, everyone, and thank you for joining our call today. I want to start off by saying how proud I am of the Harmony team and their exceptional performance this quarter. It reaffirms Harmony's reputation for executional excellence. As we have shared, Q3 was a very strong quarter for Harmony. We reported $239.5 million in net revenue for the quarter, representing 29% growth year-on-year. And with this momentum, we recently raised our net revenue guidance for the year from $820 to $860 million, taking it up to $845 to $865 million. We had robust cash generation of $106 million, bringing our balance sheet to $778 million as of September 30th. But what I am most proud of is that this performance was driven by the highest number of quarterly patient ads for WACIX since our launch, with an average of 500 patients added this quarter, resulting in an average of 8,100 patients on WACIX at the end of Q3. Our Chief Commercial Officer, Adam Zeske, will next be providing more color on some of the things his team is doing to drive this strong momentum in our WACIX business. There are many different ways to measure impact. Delivering innovative treatments to patient populations living with unmet medical needs is a very meaningful one. With this sustained momentum, we believe WACIX is rapidly approaching a $1 billion-plus blockbuster status in narcolepsy alone. Along with our very strong commercial business, Harmony also has a robust late stage pipeline with multiple catalysts coming over the next several years. We continue to have firm conviction in our pipeline and full confidence in our R&D team to successfully execute on these programs. In fact, the IND for Pitollasen HD Our pitolis and high-dose formulation has been submitted to FDA, and we are on track to initiate two Phase III trials, one in narcolepsy and one in idiopathic hypersomnia, or IH, before the end of the year. Kumar will provide an update on our pipeline programs later in the call, including an update on the RECONNECT study in Fragile X syndrome. Turning to our balance sheet. With over $778 million in cash and cash equivalents, a disciplined approach to capital deployment, and a team with extensive industry experience, Harmony is well positioned to strategically pursue value enhancing assets to add to our pipeline and build a broader product portfolio. That is our intent. and a key component of our vision to become the leading patient-focused CNS company delivering innovative treatments that can help even more patients living with unmet medical needs. We believe that we have built something rare in our industry, a profitable, self-funding biotech company with an innovative, catalyst-rich pipeline poised to deliver meaningful value for both patients and our shareholders. It is because of this unique profile that we continue to execute from a position of strength. And coming off of our exceptional Q3 performance, we believe that Harmony is 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 outstanding commercial performance. Adam?