Harmony Biosciences Holdings, Inc.

Ladies and gentlemen, thank you for standing by and welcome to the Harmony Biosciences first quarter 2021 financial update call. At this time, all participant lines are in a listen only mode. After the speaker's presentation, there'll be a question and answer session. To ask a question during the session, you will need to press star then one on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star then zero. I would now like to hand the conference over to your host today, Lisa Cavarelli, Investor Relations. Please go ahead.

Thank you, Operator. Good morning, everyone, and thank you for joining us today as we review Harmony Bioscience's first quarter 2021 financial performance and provide business updates. Before we begin, I encourage everyone to go to the investor section of the Harmony Biosciences website to find the press release and slides that accompany our presentation today, including a reconciliation of the GAAP to non-GAAP financial measures. At this stage of our company lifecycle, we believe non-GAAP financial results better represent the underlying economics of our business. Our presenters on today's call are John Jacobs, President and CEO, Dr. Jeffrey Dano, Chief Medical Officer, Jeffrey Dirks, Chief Commercial Officer, and Sandeep Kapadia, Chief Financial Officer. Moving 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, and our actual results may differ materially. I encourage you to consult the risk factors referenced in our SEC filings for additional details. At this time, I'd like to turn the call over to our CEO, John Jacobs. John?

Thank you for the introduction, Lisa. And I would also like to thank all of the participants for joining our first quarter 2021 conference call this morning. I am pleased to share with you that once again, we reported strong sales for WCAG with Q1 2021 revenues of approximately $60 million. and achieved profitability for the first time in our company history. We delivered these results despite the lingering challenges of a pandemic and the anticipated seasonal payer dynamics that impact all branded and specialty products in the first quarter, largely due to insurance resets at the beginning of each year. We believe this performance, driven by continued strong demand for Wakex, underscores that Wakex is addressing significant unmet medical needs in the narcolepsy market as our first-in-class, meaningfully differentiated product for people living with this rare neurological condition. Since our inception in 2017, we have focused on developing and marketing novel therapeutic options for people living with rare neurological diseases. Our commitment to these patients has never faltered, and we continue to help an expanding number of narcolepsy patients with WAKIX while making significant progress on our new clinical programs. which are designed to expand the utility of WCAG to new patient populations beyond narcolepsy, including Prader-Willi syndrome and myotonic dystrophy. Harmony's success is driven by our hardworking employees, the patients and healthcare professionals that have embraced WCAG, and the investigators and patients involved in our clinical trials. The momentum we saw in 2020 has continued into 2021. With our robust sales trajectory and strong cash position, Harmony is well positioned to continue to execute on our three pillars of growth this year, which are seen on slide three and include. Pillar one, optimize the commercial performance of WCAG. We reported Q1 net revenues of $59.7 million driven by growth in the average number of patients and the number of healthcare professionals prescribing WCAG since launch. Pillar two, Expand the clinical utility of WCAGGS. By mid-year, we expect to have two phase two programs in the clinic investigating Pitocin for potential new indications. And pillar three, acquire new assets to expand our portfolio. We have a dedicated team which is focused on identifying new assets for potential acquisition within our area of expertise in order to expand our pipeline. We are starting this process early in our company life cycle so we have the time to be thoughtful in our approach and to execute well without unnecessary distraction to our core business with Wayfix. With more than $140 million in cash and cash equivalents on the balance sheet, continued positive sales growth, and now having reached profitability, we are well positioned to act. In summary, I am very pleased with our first quarter performance and look forward to keeping you updated on our progress as we continue to advance our three-pillar strategy to grow the company. I would now like to turn over the call to Jeff Dirks, our Chief Commercial Officer. Jeff?