PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) this week reported financial results and business updates for the fourth quarter and full year ended December 31, 2022.
“We delivered another strong quarter in Q4, finishing the year with continued momentum in both our commercial business for WAKIX and in our clinical development programs for pitolisant,” stated Jeffrey M. Dayno, M.D., interim chief executive officer and chief medical officer of Harmony.
“Looking ahead, we remain confident in the ongoing performance of WAKIX. Harmony remains a growth story, with the focus on advancement of our life cycle management programs for pitolisant and acquisition of new assets to build out our pipeline to drive additional growth. With that as our focus, I am excited to lead the company forward.”
Fourth Quarter 2022 Financial Results
Net product revenues for the quarter ended December 31, 2022 were $128.3 million, compared to $91.2 million for the same period in 2021. The 40.7% growth versus the same period in 2021 is primarily attributed to strong commercial sales of WAKIX driven by continued organic demand. The average number of patients on WAKIX increased to approximately 4,900 for the quarter ended December 31, 2022.
GAAP net income for the quarter ended December 31, 2022, was $48.5 million, or $0.79 per diluted share, compared to GAAP net income of $22.7 million, or $0.38 per diluted share, for the same period in 2021. Non-GAAP adjusted net income was $61.9 million, or $1.01 per diluted share, for the quarter ended December 31, 2022, compared to Non-GAAP adjusted net income of $30.4 million, or $0.50 per diluted share, for the same period in 2021.
Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included in the Company’s original release.
Harmony’s operating expenses include the following:
- Research and Development expenses were $10.1 million in the fourth quarter of 2022, as compared to $7.5 million for the same quarter in 2021, representing a 35.4% increase;
- Sales and Marketing expenses were $21.1 million in the fourth quarter of 2022, as compared to $19.1 million for the same quarter in 2021, representing a 10.3% increase;
- General and Administrative expenses were $22.6 million in the fourth quarter of 2022, as compared to $18.2 million for the same quarter in 2021, representing a 24.4% increase; and
- Total Operating Expenses were $53.8 million in the fourth quarter of 2022, as compared to $44.8 million for the same quarter in 2021, representing a 20.2% increase.
Full Year 2022 Financial Results
Net product revenues for the year ended December 31, 2022 were $437.9 million, compared to $305.4 million for 2021. The 43.4% growth versus the same period in 2021 is primarily attributed to strong commercial sales of WAKIX driven by continued organic demand.
GAAP net income for the year ended December 31, 2022, was $181.5 million, or $2.97 per diluted share, compared to GAAP net income of $34.6 million, or $0.58 per diluted share, for 2021. The increase in GAAP net income was primarily driven by the release of the valuation allowance on our deferred tax assets, which resulted in a $74.5 million income tax benefit for the year ended December 31, 2022, partially offset by a $30.0 million initial licensing fee as part of the 2022 Licensing and Commercialization Agreement with Bioprojet (the “2022 LCA”). Non-GAAP adjusted net income was $183.5 million, or $3.00 per diluted share, for the year ended December 31, 2022, compared to Non-GAAP adjusted net income of $91.7 million, or $1.55 per diluted share, for 2021.
Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included in the Company’s original release.
Harmony’s operating expenses include the following:
- Research and Development expenses were $70.9 million for the year ended December 31, 2022, as compared to $30.4 million for the prior year, representing a 133.4% increase, primarily driven by a $30.0 million initial licensing fee as part of the 2022 LCA;
- Sales and Marketing expenses were $79.3 million for the year ended December 31, 2022, as compared to $68.1 million for the prior year, representing a 16.4% increase;
- General and Administrative expenses were $84.0 million for the year ended December 31, 2022, as compared to $63.9 million for the prior year, representing a 31.5% increase; and
- Total Operating Expenses were $234.2 million for the year ended December 31, 2022, as compared to $162.4 million for the prior year, representing a 44.2% increase.
As of December 31, 2022, Harmony had cash, cash equivalents and investment securities of $345.7 million, compared to $234.3 million on December 31, 2021.
Recent Updates
- Continued strong momentum in patient enrollment in the Phase 3 registrational trial (INTUNE Study) in adult patients with IH, with approximately 85% of the planned clinical trial sites activated.
- Received the full data set from the Prader-Willi Syndrome (“PWS”) Phase 2 proof-of-concept study at the end of 2022, which we are analyzing in preparation for an end-of-Phase 2 meeting with the U.S. Food and Drug Administration (“FDA”) to discuss the results. We intend to advance our development program in patients with PWS to a Phase 3 trial.
- Enrollment continues in our Myotonic Dystrophy (“DM1”) study. We anticipate topline data from this Phase 2 proof-of-concept trial in the fourth quarter of 2023.
- Regarding a pediatric narcolepsy indication, our partner Bioprojet received a positive opinion from the European Medicines Agency’s (“EMA”) Committee for Medicinal Products for Human Use (“CHMP”) on January 26, 2023, and expects an approval for a pediatric narcolepsy indication from the EMA within 60 days of the positive CHMP opinion. We intend to work with Bioprojet on a path forward towards the submission to FDA of a supplemental new drug application for pediatric narcolepsy.
- Regarding pediatric exclusivity, we received feedback from the FDA on our Pediatric Written Request and will use this to prepare a proposed pediatric study request to submit to FDA in order to gain alignment with the agency, in pursuit of pediatric exclusivity for WAKIX.
For more information, please visit www.harmonybiosciences.com.
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