Harmony Biosciences Holdings, Inc.

Good morning. My name is Gretchen, and I will be a conference operator today. At this time, I would like to welcome everyone to the Harmony Biosciences Third Quarter 2022 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'd 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 Louis Semay, head of investor relations. Please go ahead. Louis Semay, head of investor relations.

Thank you, operator. Good morning, everyone, and thank you for joining us today as we review Harmony Biosciences third quarter 2022 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 presenters on today's call are John Jacobs, President and CEO, Dr. Jeff Friedano, Chief Medical Officer, Jeffrey Dirks, Chief Commercial Officer, and Sandeep Kapadia, Chief Financial Officer. Moving on to slide two. 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, John Jacobs. John?

Thank you, Louis, and thank you, everyone, for joining our conference call today. We delivered another strong quarter in Q3 as we continued to execute on our three-pillar growth strategy, and we are excited about the momentum we see in the business, positioning us well for the remainder of the year. I would now like to highlight our progress on each of the three pillars of our growth strategy in the context of Q3 2022 performance, or on slide three. Starting with pillar one, which is to optimize the commercial performance of WCAG. In Q3 2022, we delivered another strong quarter for WCAG, with net sales of $117.2 million, a 45% year-over-year increase for the quarter. Our performance reflects the continued demand for WAKIX and the significant unmet need that remains in the narcolepsy market. For the remainder of the year, we expect continued growth for WAKIX, and we believe that the vast market opportunity which remains in narcolepsy provides us with the opportunity to grow WAKIX for years to come. Let's move on to Pillar 2, which is to expand the clinical utility of WAKIX beyond narcolepsy. This morning, we announced top-line results from our Phase II proof-of-concept study in patients with Prader-Willi syndrome. Top-line data showed a positive signal on the primary outcome of excessive daytime sleepiness, and we intend to advance this clinical program in PWS. Dr. Jeff Dana will provide more details on the top-line study results later in the call. We also continue to make excellent progress on our Phase III in-tune study for wakeks and idiopathic hypersomnia, or IH. This opportunity, if successful, could be the next potential indication for WCAGS. The IH opportunity is synergistic with our existing expertise and infrastructure with the same HCP call universe as narcolepsy, which will allow for significant efficiencies for the launch if we succeed. We are excited with the continued advancement of our pipeline programs and are hopeful that these efforts could lead to additional indications for WCAGS. And finally, Pillar 3, acquiring new assets through business development to expand our portfolio beyond WCAG. In late September, we closed our new agreement with Buyer Prejet, which will enable us to pursue new therapeutics based on pitulicin for the treatment of narcolepsy and potentially other indications mutually agreed to by the parties. If successful, these efforts could expand Harmony's franchise in narcolepsy and potentially other indications by yielding one or more new products with the potential to launch during the WCAG lifecycle. We look forward to providing additional updates as we advance these efforts. As we have said before, we began our business development efforts early in our company history so we could take the time to be thoughtful and prudent in what we acquire and flexible in the types of transactions we're able to consider. Over time, our intention is to develop a broad portfolio of rare orphan neurology assets and or assets in other neurological diseases where we can leverage our existing expertise and infrastructure. To achieve this, we intend to leverage our strong financial position to acquire additional assets over time and across a range of development stages, including both early and later stage, with the potential to launch both during and after WACIC's lifecycle. We are in a solid position to execute on Pillar 3 as our business fundamentals with Wakex remain strong. We had approximately $316 million in cash, cash equivalents, and investment securities as of Q3, and we anticipate that we will continue to generate cash moving forward. Overall, I'm extremely pleased with the progress on our three-pillar growth strategy. We remain confident in WCAG being a potential $1 billion-plus franchise in the coming years via narcolepsy and additional indications. And with that as a foundation, I am truly excited about what we can achieve next at Harmony. I would now like to turn the call over to Jeff Dirks, our Chief Commercial Officer, to provide more details on our commercial performance. Jeff?