Harmony Biosciences Holdings, Inc.

Good day and thank you for standing by. Welcome to the second quarter 2021 financial and business update conference call. At this time, all participants are in a listen-only mode. After the speaker's presentation, there will be a question-and-answer session. To ask a question during that session, you will need to press star 1 on your telephone. Please be advised that today's conference is being recorded. If you require any further assistance, please press star 0. I would now like to hand the conference over to your speaker, Lisa Caporelli, Head of Investor Relations.

Thank you, Operator. Good morning, everyone, and thank you for joining us today as we review Harmony Biosciences' second quarter 2021 financial performance and provide business updates. Before we start, I encourage everyone to go to the investor section of the Harmony Biosciences website to find the press release and slides that accompany our discussion today, 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 economics of our business. Our presenters on today's call are John Jacobs, President and CEO, Dr. Jeffrey Danos, Chief Medical Officer, Jeffrey Dirks, Chief Commercial Officer, and Sandeep Kapadia, CFO. Moving on to slide number 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 would like to turn the call over to our CEO, John Jacobs. John?

Thank you, Lisa. And I would also like to extend my sincere thanks to all of the participants for joining our second quarter 2021 conference call today. We are halfway through the year, and I am extremely pleased with the progress our team has made to date. Please allow me to elaborate on our achievements in the context of our three pillars growth strategy, which is shown on slide three. Pillar one, optimize the commercial performance of WACICS. Q2 represented a strong quarter for Harmony. as we delivered nearly $74 million in net sales for Wakex and achieved our second profitable quarter in company history. This significant growth, nearly 24% versus the prior quarter Q1, was driven by a continued increase in the average number of patients on Wakex and in the number of healthcare professionals prescribing our product, both of which further underscore the significant unmet medical need in this market for a truly novel mechanism of action and differentiated product profile which WAKIX provides. Moving on to Pillar 2. Pillar 2 is expand the clinical utility of WAKIX beyond narcolepsy. We are excited to now be evaluating pitilessin in two additional rare disease patient populations beyond narcolepsy, both with significant unmet medical need and where there are no or limited approved therapies. In addition to our Phase II clinical trial in patients with Prader-Willi syndrome that we initiated at the end of last year, in Q2, we initiated a Phase II trial in patients with myotonic dystrophy. We are also considering additional indications for WCAG in other rare neurological diseases, and we intend to broaden our lifecycle management efforts for this unique product consistent with our strategy for long-term growth. And finally, Pillar 3. acquire new assets to expand our portfolio beyond WACICS. Through the efforts of our dedicated business development team, I am excited that we acquired our first additional asset beyond WACICS, HBS-102, which is a potential first-in-class molecule with a novel mechanism of action. HBS-102 gives us the opportunity to once again lead with the science in narcolepsy and other rare neurological diseases. As you will hear from Dr. Jeff Dano, we believe that HBS-102, with its unique mechanism of action, potentially represents the next generation of targeted therapy for narcolepsy, beyond those working through histamine and other neurotransmitter systems in the brain, including orexin. We view this acquisition as another important step on our journey to becoming a leading rare neurological disease company. Our business development strategy is intended to transform Harmony into a multi-product company with a robust, catalyst-rich pipeline of innovative therapies at various stages of development with the potential for launch both during and after WCAG's lifecycle. An important aspect of this strategy is that we're focusing on assets in the rare neurological arena where we can leverage our existing expertise and infrastructure, enabling us to optimize development and launch while managing costs, which in turn is intended to create long-term value for our stakeholders. To further support this initiative and the long-term growth of Harmony, we have entered into a strategic collaboration with Blackstone that gives us access to additional capital while reducing our current cost of capital and enhances our flexibility so we can continue to invest in our growth strategy. Sandeep will speak more about this later in the call. On that note, I would like to turn the call over to Jeff Dirks, our Chief Commercial Officer. Jeff?