Harmony Biosciences Holdings, Inc.

Ladies and gentlemen, thank you for standing by, and welcome to the Harmony Biosciences fourth quarter and full year 2020 financial conference call. At this time, all participant lines are in a listen-only mode. After the speaker's presentation, there will be a question and answer session. To ask a question during the 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 today, Lisa Caporelli. Thank you. Please go ahead, ma'am. Thank you, operator.

Good morning, everyone, and thank you for joining us today as we review Harmony Biosciences' fourth quarter and full year 2020 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 discussion today. including a reconciliation of the gap to non-gap financial measures. At this stage of our company lifecycle, we believe non-gap financial results better represent the economics of our business. Our presenters on today's call are John Jacobs, CEO, Dr. Jeffrey Dano, Chief Medical Officer, Jeffrey Dirks, Chief Commercial Officer, and Susan Drexler, CFO. 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 discussed 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, Lisa. Good morning, everyone, and thank you for joining us. At Harmony, we are focused on developing and commercializing treatments for patients living with rare neurological disorders who have unmet medical needs. With a differentiated product profile and unique attributes of our commercial product weight X, we are providing an important new treatment option for adult narcolepsy patients and the healthcare professionals who treat them. I am very pleased with the market adoption of WCAG as indicated by our strong first full year of commercial sales, approximately $160 million, as well as the achievement of several clinical and regulatory milestones in our life cycle management program, all of which were possible due to the dedication, commitment, passion, and drive of the entire team at Harmony. These accomplishments not only affirm our three pillars of growth strategy, and highlight the opportunity that WCAG represents as a treatment for narcolepsy, but also serve as the foundation from which we expect strong year-on-year performance that will drive future value for the patients we serve and for our shareholders. It goes without saying that 2020 was the most challenging year that many of us will ever face in our lifetimes, as we all navigated the complexities and constraints of an unprecedented global pandemic. Despite these challenges and in the face of adversity, the Harmony team persevered to drive WCAG sales growth, achieve regulatory milestones, advance clinical programs, and migrate the company from private to public, making 2020 the most productive year yet in our company's history. With the additional gross proceeds of $147.6 million from our IPO and subsequent listing on the NASDAQ global market, and Russell 2000 and 3000 indices, we strengthened our financial position and increased visibility with investors, laying the foundation for us to enter 2021 well-positioned to advance and execute upon all three pillars of our growth strategy. Let me share with you the progress we've achieved in 2020 on our three pillars of growth. Pillar number one, optimize the commercial launch of WakeX. In 2020, we engaged with healthcare providers and patients to expand the awareness and utilization of WAKIX in narcolepsy and drive demand, which resulted in strong growth, with Q4 2020 revenue of $56.3 million and full-year revenue of approximately $160 million. Late last year, we expanded the utility of WAKIX by gaining approval of the cataplexy indication in adult patients with narcolepsy, which has been well received by both the healthcare providers and patient communities. And as you'll hear during our commercial overview, we are seeing continued increases in the average number of patients on WACICS and the number of healthcare professionals prescribing WACICS, which is driven by the truly differentiated product profile that WACICS offers. Let's move on to pillar number two, expand the clinical utility of WACICS. Based on the unique mechanism of action of Pitocin, we believe we have a portfolio in a product opportunity, and our clinical team has made extensive progress on the key clinical programs that represent new opportunities for us to help patients beyond narcolepsy. Late last year, we initiated and enrolled the first patient in our Phase II trial in patients with Prader-Willi syndrome. We are excited to collaborate with the Prader-Willi patient and medical community to explore treatment options that do not currently exist for these patients to address their unmet medical needs. In addition, our team submitted an IND for a clinical development program in myotonic dystrophy. With the IND now open, we are on track to initiate a phase two trial in patients with DM1 during the first half of this year. Throughout the year, we highlighted the strong clinical data for WCAGS with the medical community through the presentation of multiple posters at the annual sleep conference and other medical meetings. And lastly, our efforts are on track toward initiating a phase three trial in pediatric patients with narcolepsy later this year. Based on this progress, Petolescent is poised to be evaluated in three late-stage trials during 2021. And finally, our third pillar, acquire new assets to expand our portfolio. Though WACIX alone represents a significant growth opportunity for Harmony, in line with our strategy for growing the company and accelerating long-term value accretion for our shareholders, We intend to acquire additional assets to expand our portfolio beyond WAKIX. Our dedicated business development team is continuing to focus their efforts on pursuing the acquisition of additional assets, co-development and or co-promotion opportunities that would be complimentary to our existing commercial footprint and core areas of expertise. As we enter 2021, we believe that Harmony is very well positioned financially and strategically to continue to grow by executing on all three pillars of our growth strategy, which will enable us to achieve our objectives as an organization and ultimately to serve patients through the continued development and introduction of innovative therapies. And with that, I'll turn the call over to Jeff Dirks to provide a commercial update. Jeff?