Harmony Biosciences Surpasses $2 Billion in Cumulative Revenue, Highlights Robust Pipeline and Expansion into Rare CNS Therapeutic Areas
Plymouth Meeting, PA – October 29, 2024 – Harmony Biosciences Holdings, Inc. (HRMY), a leading pharmaceutical company focused on developing and commercializing innovative therapies for patients with rare neurological diseases, announced record financial results for the third quarter of 2024. The company reported net revenue of $186.0 million for the quarter ending on September 30, 2024, surpassing $2 billion in cumulative net revenues since the launch of WAKIX® (pitolisant) in adult narcolepsy in November 2019.
Harmony Biosciences is rapidly evolving into a catalyst-rich, self-funding biotech company with a robust late-stage pipeline. This growth is driven by its commitment to addressing unmet medical needs for people living with CNS disorders that have limited or no treatment options. The company recently hosted an Investor Day on October 1, 2024, where it shared its vision for the future and outlined its key growth strategies.
“Going into Q4, Harmony has great momentum. During our Investor Day, we shared new data in support of our confidence and excitement about the company’s growth trajectory as we advance our robust, catalyst-rich, late-stage pipeline and expand into additional rare CNS therapeutic areas,” said Jeffrey M. Dayno, M.D., President and Chief Executive Officer of Harmony Biosciences. “We are building on our success in sleep/wake with a strategy focused on continuous innovation, patient impact, and long-term value creation for our shareholders, and, if successful, our current pipeline is poised to deliver over $3 billion in net revenue going forward.”
Key Highlights
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WAKIX
: Net sales for the third quarter were $186.0 million, driven by continued organic demand and the broad clinical utility of WAKIX. The average number of patients on WAKIX increased by approximately 250 sequentially to approximately 6,800 for the quarter ended September 30, 2024.*
Pitolisant in Idiopathic Hypersomnia (IH)
: New data from the Long-Term Extension study demonstrated robust and sustained efficacy of pitolisant in patients with IH. Harmony is on track to submit an sNDA for pitolisant in IH in Q4 2024.*
Next-Gen Pitolisant-GR and Pitolisant-HD Programs
: These programs are designed to enhance pitolisant’s efficacy and tolerability, extending the pitolisant franchise into the mid-2040s.*
Orexin-2 Agonist Program
: BP1.15205 (formerly TPM-1116) has the potential to be a best-in-class orexin-2 receptor agonist, with IND expected in mid-2025. This program will further expand Harmony’s leadership in sleep/wake disorders beyond the 2040s.*
Rare Epilepsy
: EPX-100 (clemizole hydrochloride) is the most advanced development program in the 5-HT2 agonist class. It is currently in a pivotal Phase 3 registration trial in Dravet syndrome (DS) and is on track to initiate a Phase 3 registration trial in Lennox-Gastaut syndrome (LGS) before year-end.*
Neurobehavioral
: The ZYN-002 Pivotal Phase 3 RECONNECT trial in Fragile X syndrome is ongoing, with topline data expected in mid-2025. Harmony anticipates initiating a pivotal Phase 3 trial in 22q11.2 deletion syndrome in 2025.Financial Results
* Net product revenues for the third quarter of 2024 were $186.0 million, compared to $160.3 million for the same period in 2023, representing a 16% increase. This growth is primarily attributed to strong commercial sales of WAKIX.
* GAAP net income for the quarter ended September 30, 2024, was $46.1 million, or $0.79 earnings per diluted share, compared to GAAP net income of $38.5 million, or $0.63 earnings per diluted share, for the same period in 2023.
* As of September 30, 2024, Harmony had cash, cash equivalents, and investments of $504.7 million, compared to $425.6 million as of December 31, 2023.
2024 Guidance
Harmony reiterates its 2024 net product revenue guidance of $700 million to $720 million.
Conference Call
Harmony Biosciences will host a conference call and webcast to discuss its third-quarter 2024 financial results today, October 29, 2024, at 8:30 a.m. ET. The live and replay webcast of the call will be available on the investor relations page of the company’s website at https://ir.harmonybiosciences.com/.
About Harmony Biosciences
Harmony Biosciences is a pharmaceutical company dedicated to developing and commercializing innovative therapies for patients with rare neurological diseases who have unmet medical needs. Driven by novel science, visionary thinking, and a commitment to those who feel overlooked, Harmony Biosciences is nurturing a future full of therapeutic possibilities that may enable patients with rare neurological diseases to truly thrive.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are neither promises nor guarantees, but involve known and unknown risks, uncertainties, and other important factors that may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements, including, but not limited to, the following: our commercialization efforts and strategy for WAKIX; the rate and degree of market acceptance and clinical utility of pitolisant in additional indications, if approved, and any other product candidates we may develop or acquire, if approved; our research and development plans, including our plans to explore the therapeutic potential of pitolisant in additional indications; our ongoing and planned clinical trials; our ability to expand the scope of our license agreements with Bioprojet Société Civile de Recherche (“Bioprojet”); the availability of favorable insurance coverage and reimbursement for WAKIX; the timing of, and our ability to obtain, regulatory approvals for pitolisant for other indications as well as any other product candidates; our estimates regarding expenses, future revenue, capital requirements and additional financing needs; our ability to identify, acquire and integrate additional products or product candidates with significant commercial potential that are consistent with our commercial objectives; our commercialization, marketing and manufacturing capabilities and strategy; significant competition in our industry; our intellectual property position; loss or retirement of key members of management; failure to successfully execute our growth strategy, including any delays in our planned future growth; our failure to maintain effective internal controls; the impact of government laws and regulations; volatility and fluctuations in the price of our common stock; the significant costs and required management time as a result of operating as a public company; the fact that the price of Harmony’s common stock may be volatile and fluctuate substantially; statements related to our intended share repurchases and repurchase timeframe and the significant costs and required management time as a result of operating as a public company. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission (the “SEC”) on February 22, 2024, and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements made in this press release. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change.
