Company Overview - Harmony Biosciences was launched in October 2017 and is focused on growing its pipeline and company presence in the biotech sector [2][5] - The leadership team includes Jeffrey Dayno, President and CEO, who has extensive experience in clinical academic medicine and the biopharma industry, and Sandip Kapadia, Chief Financial Officer, with over 25 years in biotech and pharma [2][3] Industry Insights - The biotech industry is viewed as more dynamic and exciting compared to large pharmaceutical companies, highlighting the innovative nature of biotech [5][4]

Summary of Harmony Biosciences Conference Call Company Overview - **Company**: Harmony Biosciences - **Founded**: October 2017 - **Key Executives**: Jeffrey Dayno (President and CEO), Sandip Kapadia (CFO) [4][5] Industry and Market Context - **Industry**: Biopharmaceuticals focusing on neurological disorders - **Market Size**: Approximately 80,000 patients diagnosed with narcolepsy [9] - **Pipeline**: Robust late-stage pipeline with eight assets across 13 development programs, including six in phase 3 by the end of the year [13] Core Products and Pipeline - **Wakix (Pitolisant)**: - Commercial product for narcolepsy, tracking towards $1 billion in revenue with a 16% sales growth in Q2 [41][43] - Pediatric exclusivity expected to extend market protection until Q3 2030 [42] - Current sales guidance for the year is $820 to $860 million [43] - **ZYN002**: - Targeting Fragile X syndrome, pivotal phase 3 program with top-line data readout expected soon [14][52] - Unique delivery method (transdermal) and synthetic formulation without THC, differentiating it from competitors [17] - Potential market opportunity with 80,000 patients in the U.S., with 60-70% fully methylated [38] - **EPX-100**: - In phase 3 trials for Dravet syndrome and Lennox-Gastaut syndrome [13] - **Erexin Program**: - First-in-human studies expected later this year [57] Key Points on ZYN002 - **Mechanism**: Targets endocannabinoid system disruption in Fragile X syndrome [15][16] - **Clinical Trials**: Phase 2 showed significant outcomes in patients with complete methylation of the FMR1 gene [18][23] - **Regulatory Engagement**: Positive interactions with FDA regarding trial design and endpoints [26][40] Growth Strategies - **Lifecycle Management**: - Introduction of gastro-resistant (GR) and high-dose (HD) formulations of Pitolisant to extend market presence [45][46] - Focus on differentiating new formulations to mitigate loss of exclusivity risks [51] - **Commercial Strategy**: - Strong payer access and broad prescriber universe to drive continued growth [44][50] Future Outlook - **Key Value Drivers**: - Anticipated positive data from ZYN002 and advancement of Pitolisant HD programs [52] - Potential for business development opportunities to expand the pipeline [54] - **Market Position**: - Harmony Biosciences is well-positioned with a strong balance sheet and active in business development [52][54] Additional Insights - **Regulatory Environment**: Consistent communication with FDA despite administrative changes [40] - **Patient-Centric Approach**: Emphasis on the need for approved therapies for conditions like Fragile X syndrome [24] This summary encapsulates the key points discussed during the Harmony Biosciences conference call, highlighting the company's strategic direction, product pipeline, and market opportunities.

Group 1 - The article promotes a weekly newsletter focused on stocks in the biotech, pharma, and healthcare industries, aimed at both novice and experienced investors [1] - The newsletter provides insights on key trends, catalysts driving valuations, product sales forecasts, and integrated financial statements for major pharmaceutical companies [1] - The author, Edmund Ingham, has over 5 years of experience in covering biotech, healthcare, and pharma, and has prepared detailed reports on more than 1,000 companies [1]

Financial Performance - Harmony Biosciences reported quarterly earnings of $0.68 per share, missing the Zacks Consensus Estimate of $0.78 per share, and showing an increase from $0.20 per share a year ago, resulting in an earnings surprise of -12.82% [1] - The company posted revenues of $200.49 million for the quarter ended June 2025, which was 1.29% below the Zacks Consensus Estimate, but an increase from $172.81 million year-over-year [2] Market Performance - Harmony Biosciences shares have increased approximately 3.3% since the beginning of the year, compared to the S&P 500's gain of 7.6% [3] - The stock currently holds a Zacks Rank 3 (Hold), indicating it is expected to perform in line with the market in the near future [6] Future Outlook - The current consensus EPS estimate for the upcoming quarter is $0.83 on revenues of $219.89 million, and for the current fiscal year, it is $3.19 on revenues of $845.59 million [7] - The outlook for the Medical - Biomedical and Genetics industry, where Harmony operates, is currently in the bottom 43% of over 250 Zacks industries, which may impact the stock's performance [8]

Financial Data and Key Metrics Changes - The company reported net revenue of $200.5 million for Q2 2025, representing a 16% increase year over year from $172.8 million in the prior year quarter [6][28]. - Non-GAAP adjusted net income for Q2 2025 was $53.8 million, or $0.92 per diluted share, compared to $24.5 million, or $0.43 per diluted share in the prior year quarter [29]. Business Line Data and Key Metrics Changes - The core product, Wakix, achieved net sales of $200.5 million in Q2 2025, with an average of 7,600 patients, reflecting an increase of approximately 400 average patients for the quarter [14][28]. - The company is advancing multiple late-stage development programs across three core areas: sleep-wake, neurobehavioral, and rare epilepsies, with peak sales potential of $1 billion to $2 billion across multiple indications [7][12]. Market Data and Key Metrics Changes - The U.S. market for Fragile X syndrome is estimated to have around 80,000 patients, similar in size to the diagnosed narcolepsy market, but currently lacks FDA-approved treatments [9][21]. - The company anticipates significant growth in the narcolepsy market, projecting Wakix to achieve blockbuster status with over $1 billion in annual revenue [6][17]. Company Strategy and Development Direction - Harmony Biosciences aims to build a robust pipeline with eight innovative assets across 13 development programs, including up to six Phase III trials by the end of the year [12][34]. - The company is focused on expanding its commercial infrastructure and leveraging its unique position as the only non-scheduled treatment option for narcolepsy to drive growth [15][17]. Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth of Wakix and reaffirmed full-year revenue guidance of $820 million to $860 million, with expectations of achieving over $1 billion in annual revenue from narcolepsy alone [17][31]. - The upcoming top-line data readout for ZYN-two in Fragile X syndrome is viewed as a potential transformational moment for both the company and the patient community [34]. Other Important Information - The company has over $670 million in cash and cash equivalents, providing financial flexibility for strategic expansion and investments in its pipeline [13][30]. - A research collaboration with SERC Biosciences aims to develop novel regenerative cellular therapies for advanced neurological disorders, aligning with the company's commitment to patients with serious conditions [11][61]. Q&A Session Summary Question: Timing and expectations for the ReConnect top-line data readout - Management confirmed that the top-line data for the ReConnect study is on track for Q3 and emphasized the high level of confidence in achieving statistically significant outcomes [36][39]. Question: Data disclosure for the Fragile X top-line readout - The top-line data will include demographic data, safety, tolerability, and efficacy on primary and key secondary endpoints, with plans for a pre-NDA meeting if results are positive [44][45]. Question: Impact of Takeda's Orexin on the market - Management remains confident in Wakix's differentiation and its ability to continue growing despite new entrants, citing strong physician familiarity and broad clinical utility [78][79]. Question: Factors affecting revenue guidance - The company noted that trade inventory drawdown and underlying demand are key factors influencing revenue, with expectations for strong growth in the upcoming quarters [81][83].

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 growth and value of WAKIX, plans to submit an sNDA for pitolisant in idiopathic hypersomnia; our future results of operations and financial posi ...

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 June 30, 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 othe ...

Exhibit 99.1 HARMONY BIOSCIENCES REPORTS STRONG Q2 2025 FINANCIAL RESULTS AND REAFFIRMS 2025 REVENUE GUIDANCE; ON TRACK TO ANNOUNCE FRAGILE X TOPLINE DATA FROM PHASE 3 REGISTRATIONAL TRIAL IN Q3 2025 Conference Call and Webcast to be Held Today at 8:30 a.m. ET PLYMOUTH MEETING, Pa., August 5, 2025 /Business Wire/ -- Harmony Biosciences Holdings, Inc. (Nasdaq: HRMY) today announced plans to announce topline data from its phase 3 registrational clinical trial of ZYN002 in Fragile X syndrome in Q3 2025. The co ...

Company Overview - Harmony Biosciences Holdings, Inc. (HRMY) is expected to report a year-over-year increase in earnings driven by higher revenues for the quarter ended June 2025, with a consensus EPS estimate of $0.82, reflecting a +310% change [1][3] - Revenue expectations stand at $203.38 million, which is a 17.7% increase from the same quarter last year [3] Earnings Expectations - The earnings report is anticipated to be released on August 5, and the stock may rise if actual results exceed expectations; conversely, a miss could lead to a decline [2] - The consensus EPS estimate has been revised down by 5.2% over the last 30 days, indicating a bearish sentiment among analysts [4] Earnings Surprise Prediction - The Most Accurate Estimate for Harmony Biosciences is lower than the Zacks Consensus Estimate, resulting in an Earnings ESP of -2.31%, which complicates predictions of an earnings beat [12] - Despite the negative Earnings ESP, the company holds a Zacks Rank of 2 (Buy), suggesting potential for positive performance [12] Historical Performance - In the last reported quarter, Harmony Biosciences had an earnings surprise of +32.20%, with actual earnings of $0.78 per share compared to an expected $0.59 [13] - The company has successfully beaten consensus EPS estimates in the last four quarters [14] Industry Context - In the broader Zacks Medical - Biomedical and Genetics industry, Vertex Pharmaceuticals (VRTX) is also expected to report strong earnings, with an EPS estimate of $4.24, reflecting a +133.1% year-over-year change and revenues of $2.89 billion, up 9.2% [18][19] - Vertex has an Earnings ESP of +1.55% and a Zacks Rank of 3 (Hold), indicating a likelihood of beating the consensus EPS estimate [19][20]

Core Insights - Value investing focuses on identifying stocks trading below their intrinsic value, allowing investors to benefit as market prices align with true company value over time [1] - Earnings yield, calculated as earnings per share divided by stock price, is a useful metric for identifying undervalued stocks, with a higher yield indicating potential undervaluation [2][4] - A screening criterion of an earnings yield greater than 10% is established, alongside other parameters like estimated EPS growth and average daily volume [6][7] Company Highlights - IAMGOLD Corporation (IAG) is a gold exploration and mining company with projected earnings growth of 44% and 40% for 2025 and 2026, respectively, and currently holds a Zacks Rank 1 [9] - Plains GP Holdings (PAGP) is involved in crude oil and refined products transportation, with earnings growth estimates of 206% and 24% for 2025 and 2026, respectively, also holding a Zacks Rank 1 [10][11] - Hope Bancorp (HOPE) provides commercial banking services, with earnings growth estimates of 12% and 40% for 2025 and 2026, and holds a Zacks Rank 1 [12] - CommScope Holding Company, Inc. (COMM) offers communication network infrastructure solutions, with an extraordinary earnings growth estimate of 3,167% for 2025 and 28% for 2026, holding a Zacks Rank 2 [13] - Harmony Biosciences Holdings Inc. (HRMY) focuses on therapies for rare neurological disorders, with earnings growth estimates of 22% and 32% for 2025 and 2026, and holds a Zacks Rank 2 [14]