Harmony Biosciences Holdings, Inc.

Good day and thank you for standing by. Welcome to Harmony Bioscience fourth quarter 2021 financial 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 this session, you will need to press star one on your telephone. Please be advised that today's conference may be 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, Patty Bank, Investor Relations. Please go ahead.

Thank you, Operator. Good morning, everyone. And thank you for joining us today as we review Harmony Biosciences' fourth quarter and four-year 2021 financial performance and provide a business update. Before we start, I encourage everyone to go to the Investors 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 are a useful measure in understanding 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, CFO. 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, and our actual results may differ materially. I 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 Harmony Biosciences CEO, John Jacobs. John?

Thank you, Patty, and thank you, everyone, for joining our conference call today. I'm proud to say that 2021 was a very successful year for Harmony as we continue to execute on our three-pillar growth strategy and help patients who are living with rare neurological diseases. As we enter this year, we are confident that we can build upon our momentum from 2021 and make 2022 our best year yet. This year, we expect to deliver continued growth with WAKIX and to make significant progress on our vision to evolve Harmony in into a leading rare orphan neurology company with a robust multi-product portfolio and significant long-term growth potential. Now I'd like to take a few minutes to highlight our progress on each of the three pillars of our growth strategy in the context of Q4 2021 performance. Let's start with Pillar 1, which is to optimize the commercial performance of WACICS, In Q4-21, we delivered another solid quarter of sequential growth for WAKIX with revenues of $91.2 million, which represents a 13% quarter-on-quarter increase. The average number of patients on WAKIX is now approximately 3,800, and we expect continued growth and performance with WAKIX this year due to strong underlying demand, positive feedback from both the healthcare provider and patient communities, and the large and growing opportunity in narcolepsy which is currently a $2 billion-plus market segment. Let's move on to Pillar 2, which is to expand the clinical utility of WAKIX beyond narcolepsy. During Q421, we had our IND accepted for idiopathic hypersomnia, for which we intend to start a Phase III registrational trial during the first half of this year. With IH now added as part of our strategy to expand the utility of WAKIX into new patient populations, We are proud to say that this year, we should now have three clinical programs underway with Ptolema, including Prader-Willi syndrome, myotonic dystrophy, and idiopathic hypersomnia. And that brings us to pillar three, acquiring new assets through business development to expand our portfolio beyond WCAG. Over time, our intention is to develop a broad portfolio of rare orphan neurology assets and and or assets in other neurological diseases where we can leverage our existing expertise and infrastructure. And we are seeking assets across a range of development stages, including both early and later stage, with the potential to launch both during and after the WCAG lifecycle. HBS 102 was our first example of this last year. And while I can't speak to the exact timing of bringing in additional assets, it's important to note that we are beginning this journey early in our company history so we can take the time to be thoughtful and prudent in what we acquire and flexible in the types of deals we're able to consider. Even though we may be a newer organization, we have a deeply experienced and dedicated business development team. And our backgrounds in clinical development, regulatory affairs, and commercial launch execution give Harmony the internal capabilities to develop assets from very early stage all the way through to commercialization in the rare orphan neurology arena. The consistent growth of WAKIX since launch has put Harmony in a strong financial position and provides us with a stable foundation to build upon for a bright future. WAKIX is obviously at the core of our business today, and we are confident in its longevity, as well as our ability to grow this unique portfolio in a product asset. to become a potential $1 billion plus franchise in the coming years via narcolepsy and additional indications. And we believe that our strong patent suite and layers of regulatory exclusivity, which we intend to strengthen and expand, will help us optimize WACIC's potential over the long term. Our vision is to evolve into a leading rare neurology company with a broad portfolio of innovative assets, building upon our success and the strong performance of WACIC's to help even more patients who are living with rare neurological diseases. I would now like to turn the call over to Jeff Dirks, Harmony's Chief Commercial Officer. Jeff?