Harmony Biosciences Reports Second Quarter 2022 Financial Results

Harmony Biosciences

PLYMOUTH MEETING, PA — Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) this week reported financial results and business updates for the quarter ended June 30, 2022.

“Our continued momentum helped deliver another quarter of strong growth in both WAKIX® net revenue and average number of patients on WAKIX. The second quarter represented our best quarter of performance in top line prescription demand in over two years,” stated John C. Jacobs, President and Chief Executive Officer of Harmony.

“In addition, we are excited to announce our new agreement with Bioprojet, designed to leverage its drug discovery capabilities in combination with our proven commercial expertise in the U.S. market to develop innovative therapeutics based on pitolisant. If successful, these efforts could expand our franchise in narcolepsy by yielding one or more new products with the potential to launch during the WAKIX lifecycle.”

“Bioprojet is very excited about this transaction, which is designed to benefit U.S. patients and will strengthen the partnership between Bioprojet and Harmony Biosciences,” said Professor Jean-Charles Schwartz, PhD, founder of Bioprojet.

Second Quarter 2022 Financial Results

Net product revenues for the quarter ended June 30, 2022 were $107.0 million, compared to $73.8 million for the same period in 2021. The 45.0% 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 4,300 for the quarter ended June 30, 2022.

READ:  Roadway Restrictions Next Week in Philadelphia and Montgomery Counties

GAAP net income for the quarter ended June 30, 2022, was $23.5 million, or $0.39 per diluted share, compared to GAAP net income of $14.1 million, or $0.24 per diluted share, for the same period in 2021. Non-GAAP adjusted net income was $34.7 million, or $0.57 per diluted share, for the quarter ended June 30, 2022, compared to Non-GAAP adjusted net income of $21.9 million, or $0.37 per diluted share, for the same period in 2021.

Reconciliations of applicable GAAP financial measures to Non-GAAP financial measures are included at the end of this press release.

Harmony’s operating expenses include the following:

  • Research and Development expenses were $12.7 million in the second quarter of 2022, as compared to $6.5 million for the same quarter in 2021, representing a 95.0% increase, driven by enrollment in the Company’s ongoing Phase 2 and Phase 3 clinical trials;
  • Sales and Marketing expenses were $20.2 million in the second quarter of 2022, as compared to $17.0 million for the same quarter in 2021, representing an 18.4% increase;
  • General and Administrative expenses were $22.2 million in the second quarter of 2022, as compared to $14.3 million for the same quarter in 2021, representing a 55.0% increase; and
  • Total Operating Expenses were $55.0 million in the second quarter of 2022, as compared to $37.8 million for the same quarter in 2021, representing a 45.4% increase.
READ:  Trevena Reports Second Quarter 2022 Results and Provides Business Update

As of June 30, 2022, Harmony had cash, cash equivalents and investments of $258.9 million.

Recent Updates

  • In August 2022, Harmony and Bioprojet announced the signing of a new agreement focused on developing innovative therapeutics based on pitolisant, expanding Harmony’s opportunity in narcolepsy, and potentially other indications mutually agreed to by the parties. Financial terms include an upfront payment of $30 million, potential milestones and sales royalties. Closing of the agreement is contingent on clearance under the Hart-Scott-Rodino (HSR) Antitrust Improvements Act of 1976, and other customary closing conditions.
  • Phase 3 registrational trial in adult patients with IH (INTUNE Study) off to a good start and on track with site activations and patient enrollment.
  • Completed enrollment in the PWS Phase 2 proof-of concept study. On track for top line data from this trial in the fourth quarter of 2022.
  • Enrollment continues in the Myotonic Dystrophy (DM1) study. Anticipate top line data from this Phase 2 proof-of concept trial in 2023.
  • Harmony extended the $100 million delayed draw loan facility with Blackstone, which now makes those funds available into August of 2023.
READ:  Zynerba Pharmaceuticals Reports Second Quarter 2022 Financial Results

For more information, visit www.harmonybiosciences.com.

You May Also Be Interested In…

Thanks for visiting! Looking for some Chester County pride? We got you covered! Shop our MyChesCo store and show your love for Chester County, Pennsylvania. We got shirts, hats, and more – all with a unique ChesCo flair. Plus, proceeds from each purchase helps support our mission of bringing reliable information and resources to the people of Chester County.