Harmony Biosciences Holdings, Inc. (NASDAQ:HRMY) Q4 2023 Results Conference Call February 22, 2024 8:30 AM ET
Company Participants
Luis Sanay - Head of Investor Relations
Jeffrey Dayno - President and CEO
Jeffrey Dierks - Chief Commercial Officer
Kumar Budur - Chief Medical Officer
Sandip Kapadia - Chief Financial Officer and Chief Administrative Officer
Conference Call Participants
Ami Fadia - Needham & Company
Charles Duncan - Cantor Fitzgerald
Francois Brisebois - Oppenheimer
David Amsellem - Piper Sandler
Danielle Brill - Raymond James
Operator
Good morning. My name is Brittany, and I will be your conference operator today. At this time, I would like to welcome everyone to the Harmony Biosciences Fourth Quarter and Full Year 2023 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 [Operator Instructions]. Please be advised that today's conference may be recorded [Operator Instructions].
I would now like to turn the call over to Luis Sanay, Head of Investor Relations. Please go ahead.
Luis Sanay
Thank you, operator. Good morning, everyone. And thank you for joining us today as we review Harmony Biosciences fourth quarter and full year 2023 financial results and provide a business update. Before we start, I encourage everyone to go to the investors section of our Web site to find the materials that accompany our discussion today, including the 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 business performance. Our speakers on today's call are Dr. Jeffrey Dayno, President and CEO; Jeffrey Dierks, Chief Commercial Officer; Dr. Kumar Budur, Chief Medical Officer; and Sandip Kapadia, Chief Financial Officer and Chief Administrative Officer. 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 Dr. Jeffrey Dayno. Jeff.
Jeffrey Dayno
Thank you, Luis. And thanks everyone for joining our conference call today. Harmony continues to be a growth story as demonstrated by our team's accomplishments throughout 2023. We delivered another strong year of performance across the organization, growing revenue and average number of patients on WAKIX. We advanced all our clinical development programs for pitolisant, moved the next generation or next gen formulations of pitolisant into the clinic and expanded our pipeline and diversified our portfolio with the acquisition of Zynerba and the ongoing Phase 3 clinical trial in patients with Fragile X syndrome. Yesterday, we announced that FDA granted priority review for our supplemental NDA or sNDA for WAKIX in pediatric narcolepsy with a PDUFA date of June 21st. Earlier this week, we also shared that FDA granted orphan drug designation for pitolisant for the treatment of Prader-Willi Syndrome or PWS, as we are preparing to initiate our pivotal Phase 3 TEMPO study in patients with PWS down to age six. All of this reflects momentum across our organization from our commercial business with WAKIX in narcolepsy to our clinical development programs, as well as positive interactions with FDA related to these programs. These outcomes also reflect excellence and execution, and the dedication of our team to deliver on the strategy we have laid out and are executing on. In addition, we have returned capital to shareholders via our share repurchase program and will continue to take an opportunistic approach to this program throughout this year. I am very excited for the year ahead and believe that Harmony is poised to accelerate our growth in 2024.