Harmony Biosciences (HRMY) FY 2025 Conference June 09, 2025 03:20 PM ET Speaker0 Good morning, and welcome to the Goldman Sachs Healthcare Conference. Thanks so much to the team from Harmony Biosciences for just joining us here today. And yes, I guess, we'll kick it off. I would love to get started with just maybe an overview of the company. It's changed a lot in the past, let's call it year and a half. So could you give us kind of an overview of the pipeline? Speaker1 Yes, sure, Karim. Thank you for the in ...

Harmony Biosciences Holdings, Inc. (HRMY) came out with quarterly earnings of $0.78 per share, beating the Zacks Consensus Estimate of $0.59 per share. This compares to earnings of $0.67 per share a year ago. These figures are adjusted for non-recurring items.This quarterly report represents an earnings surprise of 32.20%. A quarter ago, it was expected that this company would post earnings of $0.74 per share when it actually produced earnings of $0.85, delivering a surprise of 14.86%.Over the last four qua ...

Harmony Biosciences (HRMY) Q1 2025 Earnings Call May 06, 2025 08:30 AM ET Company Participants Brennan Doyle - VP & Head of Investor RelationsJeffrey Dayno - President & CEOAdam Zaeske - EVP & CCOKumar Budur - Executive VP and Chief Medical & Scientific OfficerSandip Kapadia - CFO & Chief Administration OfficerGraig Suvannavejh - Managing DirectorPatrick Trucchio - Managing DirectorDavid Huang - Vice President Equity ResearchAshwani Verma - Executive Director - SMID Biotech & BiopharmaCharles Duncan - Manag ...

Harmony Biosciences (HRMY) Q1 2025 Earnings Call May 06, 2025 08:30 AM ET Speaker0 Good morning. My name is Angela and I will be your conference operator today. At this time, I would like to welcome everyone to Harmony Biosciences First Quarter twenty twenty five Financial Results Conference Call. All participant lines have been placed on mute to prevent any background noise. After the speakers' remarks, there will be a question and answer session. Please be advised that today's conference may be recorded. ...

Table of Contents 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 March 31, 2025 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 HOLDINGS, INC. (Exact name of registrant as specified in its charter) (State or oth ...

Financial Performance - WAKIX® (pitolisant) net revenue for Q1 2025 was $184.7 million, representing a 20% growth year-over-year[1] - GAAP net income for Q1 2025 was $45.6 million, or $0.78 earnings per diluted share, compared to $38.3 million, or $0.67 earnings per diluted share for Q1 2024[12] - Non-GAAP adjusted net income for Q1 2025 was $60.4 million, or $1.03 earnings per diluted share, compared to $50.7 million, or $0.88 earnings per diluted share for Q1 2024[12] - Net product revenue for Q1 2025 was $184.733 million, a 19.5% increase from $154.615 million in Q1 2024[44] - Gross profit for Q1 2025 was $152.739 million, compared to $127.131 million in Q1 2024, reflecting a gross margin improvement[44] - Operating income for Q1 2025 was $56.245 million, up from $52.033 million in Q1 2024, showing operational efficiency[44] - Net income for Q1 2025 was $45.560 million, compared to $38.334 million in Q1 2024, representing an increase of 18.5%[44] - GAAP reported net income per diluted share rose to $0.78 in Q1 2025 from $0.67 in Q1 2024, marking a 16% increase[46] - Non-GAAP adjusted net income per diluted share increased to $1.03 in Q1 2025, up from $0.88 in Q1 2024, a growth of 17%[46] Expenses and Investments - Research and Development expenses increased by 56% to $34.5 million in Q1 2025 compared to $22.2 million in Q1 2024[15] - Total operating expenses were $96.5 million in Q1 2025, representing a 29% increase from $75.1 million in Q1 2024[15] - Research and development expenses increased to $34.540 million in Q1 2025 from $22.189 million in Q1 2024, indicating a focus on product development[44] - Stock-based compensation expense increased to $12,450,000 in Q1 2025 from $10,434,000 in Q1 2024, an increase of 19%[46] Patient and Product Development - The average number of patients on WAKIX increased to approximately 7,200 for Q1 2025, with approximately 7,300 patients at the end of the quarter[7] - Recruitment for the Phase 3 registrational trial of ZYN002 in Fragile X syndrome is complete, with topline data expected in Q3 2025[11] - The company is on track to initiate Phase 3 registrational trials in narcolepsy and idiopathic hypersomnia (IH) in Q4 2025[7] - The company plans to submit a supplemental New Drug Application (sNDA) for pitolisant in idiopathic hypersomnia, expanding its product indications[42] - Harmony Biosciences is focused on developing therapies for rare neurological diseases, addressing significant unmet medical needs[41] - The company has received FDA Fast Track designation for ZYN002 for the treatment of behavioral symptoms in patients with Fragile X Syndrome[34] Financial Guidance and Assets - 2025 net revenue guidance is projected between $820 million and $860 million[14] - Total assets as of March 31, 2025, were $1.055 billion, up from $999.200 million at the end of 2024[45] - Cash and cash equivalents increased to $488.998 million from $453.001 million, indicating improved liquidity[45] Other Financial Metrics - Non-cash interest expense for Q1 2025 was $166,000, slightly down from $180,000 in Q1 2024[46] - Depreciation expense decreased significantly to $7,000 in Q1 2025 from $163,000 in Q1 2024[46] - The income tax effect related to non-GAAP adjustments improved to $(3,776,000) in Q1 2025 from $(4,350,000) in Q1 2024[46] - Amortization expenses remained consistent at $5,961,000 for both Q1 2025 and Q1 2024[46] - The weighted average number of shares of common stock used in non-GAAP diluted per share calculations was 58,524,566 in Q1 2025, compared to 57,597,627 in Q1 2024[46]

Q1 2025 Financial Results & Business Update May 6, 2025 Copyright © 2025 Harmony Biosciences. All rights reserved. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including statements regarding our full year 2024 net product revenue, expectations for the gr ...

Looking for a stock that has been consistently beating earnings estimates and might be well positioned to keep the streak alive in its next quarterly report? Harmony Biosciences Holdings, Inc. (HRMY) , which belongs to the Zacks Medical - Biomedical and Genetics industry, could be a great candidate to consider.This company has an established record of topping earnings estimates, especially when looking at the previous two reports. The company boasts an average surprise for the past two quarters of 19.15%.Fo ...

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Shares of Harmony Biosciences (HRMY) have lost 10.8% in the past six months compared with the industry’s decline of 9.7%. The stock has also underperformed the S&P 500 index during this timeframe.The stock was hit last month after the company announced that it received a Refusal to File (RTF) letter from the FDA for pitolisant for the treatment of excessive daytime sleepiness (EDS) in adult patients with idiopathic hypersomnia (IH).Image Source: Zacks Investment ResearchNonetheless, the fourth-quarter resul ...