Group 1 - The market environment has favored growth stocks over the past 15 years, leading to high valuations that traditional value investors find challenging [1] - Despite skepticism from analysts regarding the overvaluation of growth stocks, their prices have continued to rise due to strong business performance [1] - Aggressive value investors who shorted these growth stocks have faced significant losses [1] Group 2 - Harmony Biosciences (NASDAQ: HRMY) is a lesser-known biotech company that presents an attractive opportunity for traditional value investors [2] - The company has experienced business success that is not fully reflected in its stock price, warranting further investigation [2] - Harmony focuses on rare neurological disorders, an area with unmet treatment needs and less competition compared to more common diseases [6][5] Group 3 - The biotechnology sector often features stocks with high valuations based on future prospects, making attractively priced options like Harmony worth examining [7]

Core Insights - The article emphasizes the importance of the price-to-book (P/B) ratio as a valuation tool for identifying undervalued stocks with high growth potential, alongside more commonly used ratios like price-to-earnings (P/E) and price-to-sales (P/S) [1][5]. Group 1: Understanding P/B Ratio - The P/B ratio is calculated by dividing market capitalization by the book value of equity, helping investors assess whether a stock is under- or overvalued [1][5]. - A P/B ratio of less than one indicates that a stock is trading below its book value, suggesting it may be undervalued and a good buy, while a ratio above one may indicate overvaluation [5][6]. - The P/B ratio is particularly relevant for industries with tangible assets, such as finance and manufacturing, but may be misleading for companies with high R&D expenses or negative earnings [8]. Group 2: Stock Recommendations - Five stocks with low P/B ratios and strong growth potential are highlighted: BioMarin Pharmaceutical (BMRN), General Motors (GM), Harmony Biosciences (HRMY), Adient plc (ADNT), and Gibraltar Industries (ROCK) [2][9]. - BioMarin Pharmaceutical has a projected 3-5 year EPS growth rate of 20.11% and holds a Zacks Rank of 2 with a Value Score of A [15]. - General Motors is projected to have a 3-5 year EPS growth rate of 10.65% and has a Zacks Rank of 1 with a Value Score of A [16]. - Harmony Biosciences has a projected 3-5 year EPS growth rate of 25.66% and a Zacks Rank of 2 with a Value Score of A [16]. - Adient has a projected 3-5 year EPS growth rate of 15.7% and a Zacks Rank of 2 with a Value Score of A [17]. - Gibraltar Industries has a projected 3-5 year EPS growth rate of 15.0% and a Zacks Rank of 2 with a Value Score of A [18].

Core Viewpoint - Harmony Biosciences is entering 2026 with significant momentum driven by three key factors: strong performance of WAKIX, a robust late-stage pipeline, and a strong financial profile [3][4]. Group 1: WAKIX Performance - WAKIX has shown five years of consecutive growth and profitability, with guidance for 2026 indicating over $1 billion in net revenue, positioning it to achieve blockbuster status this year [3]. Group 2: Late-Stage Pipeline - The company has five Phase III programs in the clinic targeting five distinct CNS indications, which are expected to provide multiple catalysts in the coming years [4]. Group 3: Financial Profile - Harmony Biosciences is characterized by a strong financial profile, indicating profitability and a solid foundation for future growth [4].

Harmony Biosciences FY Conference Summary Company Overview - **Company**: Harmony Biosciences (NasdaqGM:HRMY) - **Event**: 44th JPM Healthcare Conference - **Date**: January 13, 2026 Key Industry Insights - **Core Focus**: Central Nervous System (CNS) disorders, particularly narcolepsy and related conditions - **Product Highlight**: WAKIX, a treatment for narcolepsy, is on track to achieve blockbuster status in 2026 with projected net revenue exceeding $1 billion Core Points and Arguments 1. **Momentum and Growth**: Harmony enters 2026 with significant momentum driven by three key factors: WAKIX performance, a robust late-stage pipeline, and a strong financial profile [2][3] 2. **WAKIX Performance**: WAKIX has shown five years of consecutive growth and profitability, with 2025 net revenue reported at $868 million, exceeding guidance [9][41] 3. **Pipeline Development**: Five phase three programs are advancing towards distinct CNS indications, setting up multiple catalysts for growth in the coming years [2][24] 4. **Pitolisant Franchise Expansion**: The introduction of Pitolisant GR (gastro-resistant formulation) and Pitolisant HD (high-dose formulation) aims to address unmet patient needs and expand the franchise [4][13] 5. **Market Opportunity**: There are approximately 80,000 diagnosed narcolepsy patients in the US, with an additional 90,000 undiagnosed, indicating significant growth potential for WAKIX [10][42] 6. **Commercial Strategy**: Harmony has improved its commercial operations, achieving broad formulary access (80% of lives covered) and enhancing patient support systems [11][27] 7. **Regulatory Milestones**: Anticipated NDA submission for Pitolisant GR in Q2 2026, with a PDUFA date expected in Q1 2027 [30][37] 8. **Financial Health**: Harmony maintains a strong balance sheet with over $770 million in cash, allowing for continued investment in pipeline development and business growth [44][45] Additional Important Insights - **Patient-Centric Approach**: The company emphasizes the importance of addressing patient needs, particularly in narcolepsy and related disorders, through innovative product formulations [4][14] - **Unique Product Profiles**: The differentiated profiles of Pitolisant formulations are expected to enhance clinical utility and market competitiveness [6][39] - **Future Catalysts**: Anticipated data readouts from ongoing trials in 2027 and 2028 for various CNS indications, including Prader-Willi syndrome and epilepsy programs [21][20] - **Business Development Focus**: Harmony is actively seeking strategic opportunities to expand its portfolio in the CNS space, particularly in orphan and rare diseases [44][45] This summary encapsulates the key points discussed during the conference, highlighting Harmony Biosciences' strategic direction, product pipeline, and market opportunities within the CNS industry.

Financial Performance and Growth - Harmony Biosciences anticipates net revenue between $1 billion and $1.04 billion for 2026[16] - The company's revenue has grown consistently year-over-year, with $714.7 million in 2024, $868 million in 2025, and projected growth into 2026[52] - WAKIX net revenue has shown significant growth from $160 million in 2020 to over $1 billion projected for 2026[15] Pitolisant Franchise Strategy - The company is focused on growing the WAKIX franchise, extending it with Pitolisant GR, and expanding it with Pitolisant HD[8] - Pitolisant GR has the potential to extend the pitolisant franchise with utility patents filed to 2044[9] - Pitolisant HD has the potential to expand the pitolisant patient base into new indications[9] Pipeline Development - A Phase 1 clinical PK data for BP1.15205, a potential best-in-class Orexin 2 Receptor (OX2R) Agonist, is anticipated in mid-2026[42] - Topline data from ongoing global Phase 3 trials for EPX-100 in Dravet Syndrome (DS) and Lennox-Gastaut Syndrome (LGS) are anticipated in 1H 2027[45, 47] - The company submitted an NDA for Pitolisant GR in Q2 2026, with an anticipated PDUFA date in Q1 2027[31] Market Opportunity - There are approximately 170,000 people living with narcolepsy in the U S, with over 50% undiagnosed[22]

Core Viewpoint - Investors are increasingly seeking growth stocks that demonstrate above-average growth potential, with Harmony Biosciences Holdings, Inc. (HRMY) being highlighted as a strong candidate due to its favorable growth metrics and Zacks Rank [2][10]. Group 1: Earnings Growth - Harmony Biosciences has a historical EPS growth rate of 13.1%, with projected EPS growth of 19.6% for the current year, significantly outperforming the industry average of 12.2% [5]. Group 2: Cash Flow Growth - The company exhibits a year-over-year cash flow growth of 10%, which is notably higher than the industry average of -3.8% [6]. - Over the past 3-5 years, Harmony Biosciences has maintained an annualized cash flow growth rate of 25.7%, compared to the industry average of 4.1% [7]. Group 3: Earnings Estimate Revisions - The current-year earnings estimates for Harmony Biosciences have been revised upward, with the Zacks Consensus Estimate increasing by 0.1% over the past month [9]. Group 4: Overall Positioning - Harmony Biosciences has achieved a Growth Score of A and holds a Zacks Rank 2, indicating strong potential for outperformance in the growth stock category [10][11].

Financial Performance - Preliminary unaudited net product revenue for Q4 2025 was approximately $243 million, compared to $201.3 million for the same period in 2024, representing a growth of ~21%[6] - Full year 2025 net product revenue was approximately $868 million, compared to $714.7 million for 2024, indicating a year-on-year growth of ~21%[6] - WAKIX is projected to achieve net revenue between $1.0 billion to $1.04 billion for the full year ending December 31, 2026, on track for blockbuster status in narcolepsy[6] Product Development and Pipeline - The average number of patients using WAKIX increased by ~400 to approximately 8,500 in Q4 2025, marking the third consecutive quarter of ~400+ patient additions[6] - The pitolisant franchise is expected to extend into the 2040s with next-gen formulations, including a gastro-resistant version (Pitolisant GR) anticipated for NDA submission in Q2 2026[6] - Five ongoing Phase 3 registrational clinical trials are in progress for five distinct CNS indications, reinforcing the robustness of the late-stage pipeline[6] - The Phase 3 topline data readout for Pitolisant in Prader-Willi Syndrome (PWS) is expected in the second half of 2026, supporting pediatric exclusivity for WAKIX[6] - The orexin-2 receptor agonist (BP1.15205) is currently in a Phase 1 trial, with clinical data expected in mid-2026[6] - The ZYN002 program in Fragile X syndrome is being phased out, and Harmony is no longer pursuing a 22q deletion syndrome indication[7] Company Strategy and Focus - Harmony Biosciences is positioned as a profitable, self-funding biotech with a strong balance sheet, ready to expand its commercial portfolio and pipeline[4] - Harmony Biosciences is focused on developing therapies for rare neurological diseases with significant unmet medical needs[26] - The company is developing EPX-100 (clemizole hydrochloride) for Dravet syndrome and Lennox-Gastaut syndrome, targeting central 5-hydroxytryptamine receptors[23] - Harmony plans to submit a New Drug Application (NDA) for pitolisant GR and aims to extend the pitolisant franchise into the 2040s[27] - The company emphasizes the importance of market acceptance and clinical utility for its product candidates, including pitolisant[28] - Harmony is committed to exploring the therapeutic potential of pitolisant in additional indications, including pitolisant GR and pitolisant HD[28] - The company is focused on identifying and integrating additional products with significant commercial potential[28] - Harmony acknowledges the risks associated with commercialization efforts and the competitive landscape in the pharmaceutical industry[28] - The company has a vision of combining empathy and innovation to foster therapeutic advancements for patients[26] Disease Focus - Dravet syndrome has an estimated incidence rate of 1 in 15,700, with approximately 85% of cases caused by SCN1A gene mutations[24] - Lennox-Gastaut syndrome affects around 48,000 patients in the U.S., characterized by multiple seizure types and developmental issues[25]

Core Viewpoint - Harmony Biosciences Holdings, Inc. reported strong preliminary, unaudited net product revenue for Q4 and full year 2025, indicating continued growth and profitability in the biotech sector [1] Financial Performance - The company announced Q4 2025 net product revenue of approximately $243 million [1] - Full year 2025 net product revenue reached approximately $868 million [1] - Harmony has achieved six consecutive years of revenue growth, demonstrating a solid financial trajectory [1] Business Strategy - Harmony is on track to extend the pitolisant franchise, which is a key component of its product portfolio [1] - The company is positioning itself as a profitable, self-funding biotech entity with a robust late-stage pipeline [1] - Strong long-term growth prospects are highlighted, reinforcing the company's strategic direction [1]

Core Viewpoint - Investors are evaluating the value opportunities presented by Harmony Biosciences Holdings, Inc. (HRMY) and Liquidia Corporation (LQDA) in the Medical - Biomedical and Genetics sector [1] Group 1: Zacks Rank and Earnings Estimates - HRMY has a Zacks Rank of 2 (Buy), indicating a more favorable earnings estimate revision trend compared to LQDA, which has a Zacks Rank of 3 (Hold) [3] - The stronger earnings estimate revision activity for HRMY suggests an improving analyst outlook, making it a more attractive option for investors [3] Group 2: Valuation Metrics - HRMY has a forward P/E ratio of 10.09, significantly lower than LQDA's forward P/E of 37.43, indicating that HRMY may be undervalued [5] - The PEG ratio for HRMY is 0.39, while LQDA's PEG ratio is 1.03, suggesting that HRMY offers better value relative to its expected earnings growth [5] - HRMY's P/B ratio is 2.59, contrasting sharply with LQDA's P/B of 122.26, further highlighting HRMY's relative undervaluation [6] Group 3: Value Grades - HRMY has been assigned a Value grade of A, while LQDA has a Value grade of D, indicating that HRMY is viewed more favorably by value investors [6] - The combination of Zacks Rank and Style Scores indicates that HRMY is the better investment option compared to LQDA at this time [6]

Core Viewpoint - Harmony Biosciences Holdings, Inc. is participating in the 44th Annual J.P. Morgan Healthcare Conference, indicating its active engagement in the healthcare sector and potential for investor interest [1] Company Participation - The company will be represented by Jeffrey M. Dayno, M.D., President and Chief Executive Officer, who is scheduled to present on January 13, 2026, at 4:30 p.m. PT / 7:30 p.m. ET [1] - A webcast of the presentation will be available on the investor page of Harmony's website, enhancing accessibility for investors and stakeholders [1]