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Harmony Biosciences(HRMY) - 2024 Q3 - Earnings Call Presentation
2024-10-29 17:44
C IF N Q3 2024 Financial Results and Business Updates October 29, 2024 Copyright © 2024 Harmony Biosciences. All rights reserved. Forward-Looking Statements This presentation includes forward‐looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical facts contained in these materials or elsewhere, including statements regarding Harmony Biosciences Holdings, Inc.'s (the "Company") future financial position, business strat ...
Harmony Biosciences(HRMY) - 2024 Q3 - Earnings Call Transcript
2024-10-29 17:43
Financial Data and Key Metrics Changes - Harmony reported net revenues of $186 million for Q3 2024, an increase from $160.3 million in the same quarter of the previous year, reflecting strong underlying demand for WAKIX [28][73] - Non-GAAP adjusted net income for Q3 2024 was $59.6 million or $1.03 per diluted share, compared to $58.8 million or $0.97 per diluted share in the prior year quarter [74] - The company ended Q3 with $504.7 million in cash, cash equivalents, and investments, reflecting strong cash generation of $70.5 million from operations [75] Business Line Data and Key Metrics Changes - WAKIX net revenue for Q3 2024 was $186 million, surpassing $2 billion in cumulative net revenue since its launch [28][32] - The average number of patients on WAKIX increased to approximately 6,800, with a sequential increase of about 250 patients from the previous quarter [34] - The prescriber base for WAKIX grew, with over 40% penetration among approximately 5,000 healthcare professionals [37] Market Data and Key Metrics Changes - The growth in WAKIX was attributed mainly to the adult narcolepsy patient base, with contributions from the pediatric narcolepsy indication launch [35] - Approximately 60% of new patients came from oxybate REMS enrolled healthcare professionals, while 40% came from non-oxybate prescribers [103] Company Strategy and Development Direction - Harmony aims to become a leading CNS company focused on innovative treatments for patients with unmet medical needs, with a robust late-stage pipeline expected to deliver new product launches each year for the next five years [6][7] - The company is preparing to submit an sNDA for pitolisant in idiopathic hypersomnia and is advancing next-gen formulations of pitolisant [10][17] - Harmony's pipeline includes three orphan rare CNS franchises, with peak sales potential of $1 billion to $2 billion for each franchise [8][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving the 2024 net revenue guidance of $700 million to $720 million, highlighting the potential for WAKIX to exceed $1 billion in sales in the adult narcolepsy market [29][76] - The company remains focused on executing its strategy while advancing its late-stage development programs [72][31] Other Important Information - Harmony has approximately $505 million in cash, providing financial flexibility for further business development opportunities [30] - The company is committed to addressing serious unmet medical needs in rare neurological diseases, with a focus on delivering innovative treatments [31][77] Q&A Session Summary Question: Can you provide insight on the coexistence strategy for WAKIX and the upcoming GR and HD products? - Management indicated that WAKIX will remain the foundational business, with GR expected to expand the patient base without converting existing WAKIX patients. HD is anticipated to attract a majority of current WAKIX patients due to its enhanced efficacy [80][84] Question: What is the status of the orexin program and when will additional data be presented? - Management confirmed that additional preclinical data on the orexin receptor agonist will be shared at upcoming scientific meetings, with a target for next year [86][88] Question: How does EPX-100 differentiate itself from competitors in terms of safety and clinical development? - Management highlighted EPX-100's established safety profile, its BID dosing regimen, and its advanced stage in clinical development compared to other investigational products [90][92]
Harmony Biosciences Holdings, Inc. (HRMY) Q3 Earnings and Revenues Surpass Estimates
ZACKS· 2024-10-29 13:41
Harmony Biosciences Holdings, Inc. (HRMY) came out with quarterly earnings of $0.79 per share, beating the Zacks Consensus Estimate of $0.64 per share. This compares to earnings of $0.63 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 23.44%. A quarter ago, it was expected that this company would post a loss of $0.04 per share when it actually produced earnings of $0.20, delivering a surprise of 600%.Over the last four quarter ...
Harmony Biosciences(HRMY) - 2024 Q3 - Quarterly Report
2024-10-29 12:00
Table of Contents Title of each class Trading Symbol(s) Name of each exchange on which registered UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarterly Period Ended September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 001-39450 HARMONY BIOSCIENCES ...
Harmony Biosciences(HRMY) - 2024 Q3 - Quarterly Results
2024-10-29 11:50
Exhibit 99.1 HARMONY BIOSCIENCES REPORTS STRONG THIRD QUARTER 2024 FINANCIAL RESULTS AND HIGHLIGHTS CATALYST-RICH, LATE-STAGE PIPELINE POISED TO DELIVER ONE OR MORE NEW LAUNCHES EVERY YEAR OVER NEXT FIVE YEARS WAKIX (pitolisant) Net Revenue of $186.0 Million for Third Quarter 2024; Surpassed $2B in Cumulative Net Revenue in Less Than Five Years On Track to Submit sNDA for Pitolisant in Idiopathic Hypersomnia (IH) in Q4 2024 Based on Updated Strong and Sustained Efficacy Data from Long-Term Extension Study N ...
Harmony Biosciences Holdings, Inc. (HRMY) Earnings Expected to Grow: Should You Buy?
ZACKS· 2024-10-22 15:05
The market expects Harmony Biosciences Holdings, Inc. (HRMY) to deliver a year-over-year increase in earnings on higher revenues when it reports results for the quarter ended September 2024. This widely-known consensus outlook is important in assessing the company's earnings picture, but a powerful factor that might influence its near-term stock price is how the actual results compare to these estimates.The stock might move higher if these key numbers top expectations in the upcoming earnings report, which ...
Harmony Biosciences (HRMY) Surges 6.7%: Is This an Indication of Further Gains?
ZACKS· 2024-09-27 10:26
Harmony Biosciences Holdings, Inc. (HRMY) shares rallied 6.7% in the last trading session to close at $39.79. This move can be attributable to notable volume with a higher number of shares being traded than in a typical session. This compares to the stock's 5.2% gain over the past four weeks. Last month, the company announced robust financial results for the second quarter of 2024. Harmony's approved product, Wakix (pitolisant) is driving revenues while the company is making good progress with the studies o ...
Harmony Biosciences (HRMY) Upgraded to Buy: Here's What You Should Know
ZACKS· 2024-09-24 17:02
Harmony Biosciences Holdings, Inc. (HRMY) could be a solid addition to your portfolio given its recent upgrade to a Zacks Rank #2 (Buy). This rating change essentially reflects an upward trend in earnings estimates -- one of the most powerful forces impacting stock prices. A company's changing earnings picture is at the core of the Zacks rating. The system tracks the Zacks Consensus Estimate -- the consensus measure of EPS estimates from the sell-side analysts covering the stock -- for the current and follo ...
HRMY vs. REGN: Which Stock Should Value Investors Buy Now?
ZACKS· 2024-09-24 16:47
Investors looking for stocks in the Medical - Biomedical and Genetics sector might want to consider either Harmony Biosciences Holdings, Inc. (HRMY) or Regeneron (REGN) . But which of these two stocks presents investors with the better value opportunity right now? Let's take a closer look. Everyone has their own methods for finding great value opportunities, but our model includes pairing an impressive grade in the Value category of our Style Scores system with a strong Zacks Rank. The Zacks Rank is a prove ...
Is Harmony Biosciences (HRMY) a Great Value Stock Right Now?
ZACKS· 2024-08-26 14:46
Here at Zacks, we focus on our proven ranking system, which places an emphasis on earnings estimates and estimate revisions, to find winning stocks. But we also understand that investors develop their own strategies, so we are constantly looking at the latest trends in value, growth, and momentum to find strong companies for our readers. Looking at the history of these trends, perhaps none is more beloved than value investing. This strategy simply looks to identify companies that are being undervalued by th ...