Harmony Biosciences FY Conference Summary Company Overview - **Company**: Harmony Biosciences (NasdaqGM:HRMY) - **Industry**: Biotechnology, specifically focusing on treatments for narcolepsy and epilepsy Key Points and Arguments Business Performance and Growth - Harmony Biosciences has established a strong commercial foundation, particularly with its product Wakix, which targets narcolepsy and is projected to be a $1 billion-plus opportunity in this market [2][3] - The company is profitable and self-funding its activities, allowing for continued growth in both its pipeline and commercial portfolio [3][4] Wakix Franchise - Wakix has shown consistent performance with a steady increase in patient numbers, reporting an increase of 400 patients in Q2 and 500 patients in Q3, leading to an upward revision of revenue guidance from $820-$860 million to $845-$865 million for the year [6][7] - The product is differentiated as the only non-scheduled treatment for narcolepsy, which is well tolerated and has a unique mechanism of action [8][10] - The company plans to maintain its competitive edge through life cycle management strategies, including new formulations such as gastro-resistant (GR) and high-dose (HD) versions of pitolisant [10][11] Pipeline Developments - Harmony is advancing its pipeline with new formulations and additional assets, including orexin-2 agonists currently in phase one clinical trials and EPX-100 for epilepsy in phase three trials [3][4] - Upcoming data presentations at the American Epilepsy Society meeting are expected to provide new efficacy data for EPX-100 [3] Market Dynamics and Competitive Position - The narcolepsy market is characterized by a high discontinuation rate of 30%-50% for medications, but once patients are stabilized on Wakix, they tend to remain on therapy [17] - The company emphasizes that Wakix's unique profile will remain competitive despite the introduction of generics in the market [15][16] Future Strategies - The GR formulation aims to provide a faster therapeutic effect without the need for titration, while the HD formulation targets improved efficacy and new indications for fatigue in narcolepsy patients [11][19] - Harmony is also exploring business development opportunities to expand its commercial portfolio and pipeline further [34] Challenges and Considerations - The company is currently assessing the future of its Cannabidiol Gel (ZYN002) program following disappointing phase three results, with plans to provide updates after a thorough data review [31][32] - The transition from a single product focus to a multi-franchise business model requires careful organizational growth to ensure all programs receive adequate attention [33] Additional Important Insights - The company has a robust commercial engine and is looking to leverage its balance sheet to drive further value through business development [34] - The ongoing clinical trials and product developments are expected to enhance Harmony's position in the biotechnology sector, particularly in the treatment of sleep disorders and epilepsy [3][4]

Summary of Phathom Pharmaceuticals (PHAT) FY Conference Call - June 11, 2025 Company Overview - **Company**: Phathom Pharmaceuticals - **Product**: AQUESNA, a treatment for acid-related disorders, particularly gastroesophageal reflux disease (GERD) [2][10] Key Points Recent Developments - **Leadership Change**: Steve Fosta joined as CEO a few months prior, focusing on accelerating revenue and product uptake [2][3] - **FDA Approval**: The FDA granted a citizen's petition for exclusivity, allowing Phathom to have exclusivity through 2032, which is a significant development for the company [4][9] Commercial Strategy - **Product Uptake**: AQUESNA is seeing good uptake, with a focus on increasing penetration within the gastroenterology community [2][10] - **Refill Rates**: Patients using AQUESNA report significant improvement, leading to solid refill rates and positive feedback to prescribing physicians [10][11] - **Targeting Gastroenterologists**: The company is shifting focus from primary care to gastroenterologists, as they are expected to adopt the product more quickly due to a higher need among their patients [12][14] Market Coverage - **Insurance Coverage**: Over 80% of commercial lives have coverage for AQUESNA, primarily requiring prior use of PPIs [16][17] - **Medicare and Medicaid**: Coverage is limited, with most Medicare claims being denied; however, a cash pay option is available for patients at $50 per month [19][20] Sales and Marketing - **Sales Strategy**: The company is adjusting its sales strategy to focus more on gastroenterologists, which is expected to yield better results over time [30][32] - **Direct-to-Consumer (DTC) Campaign**: Initial DTC efforts have not shown significant returns yet, but the company believes that deeper adoption within the specialty will eventually lead to increased receptivity to DTC campaigns [33][41] Financial Outlook - **Profitability Timeline**: The company aims to achieve profitability by 2026, with a clear expense target of below $55 million by Q4 2025 [35][75] - **Capital Needs**: Phathom does not anticipate needing to raise additional funds, focusing on reducing operating expenses while ramping up revenue [71][75] Future Opportunities - **Life Cycle Management**: The company is considering expanding indications for AQUESNA, including eosinophilic esophagitis (EOE), and is evaluating the potential for pediatric studies [55][60] - **Pipeline Expansion**: There is interest in exploring new indications, combination products, and in-licensing opportunities to build a robust GI franchise [64][66] Market Trends - **Seasonality**: The company expects typical Q1 softness in sales due to new health plans and deductibles, but anticipates a return to growth in Q2 [22][24] Conclusion - Phathom Pharmaceuticals is strategically positioning itself to enhance the uptake of AQUESNA through targeted marketing and sales efforts, while navigating regulatory landscapes and focusing on profitability in the coming years. The company is optimistic about its growth trajectory and potential market expansion opportunities.

Summary of Phathom Pharmaceuticals (PHAT) Conference Call - February 06, 2025 Company Overview - **Company Name**: Phathom Pharmaceuticals (PHAT) - **Established**: May 2019 - **Key Product**: Venoprazan, licensed from Takeda, launched in late 2023 - **Indications**: Approved for H. Pylori in combination with antibiotics, GERD (gastroesophageal reflux disease) in both erosive and non-erosive forms [3][4] Core Points and Arguments Product Performance and Market Position - Venoprazan has shown superiority over traditional PPIs (Proton Pump Inhibitors) in clinical trials, leading to a positive commercial trajectory [4][5] - The company has achieved over 80% commercial coverage, indicating strong market acceptance despite initial skepticism regarding physician adoption and payer coverage [13][34] - The launch has been successful, with approximately 6,000 prescriptions per week, and expectations for significant growth in 2025 [15][16] Future Plans and Studies - Phathom is pursuing life cycle management for Venoprazan, including studies for eosinophilic esophagitis (EOE), with plans to start Phase II trials in the first half of 2025 [6][10] - The Phase II study will focus on symptom improvement and resolution of fibrotic effects in the esophagus, with results expected in about two years [9][10] - The company is also exploring the potential for an over-the-counter (OTC) version of Venoprazan, which would require long-term safety data and additional studies [73][76] Regulatory and Exclusivity Issues - Phathom is currently addressing an exclusivity issue with the FDA regarding the application of GAIN exclusivity to multiple indications of Venoprazan [5][46] - The company has received patent protection until February 1930 and is pursuing regulatory exclusivity that could extend this to February 1932 [46][50] - A citizen petition has been filed to expedite the FDA's decision on the exclusivity issue, with an expected response by mid-2025 [55][56] Additional Important Insights - The company has a robust commercial team of 320 sales representatives targeting high-volume prescribers, with no plans for expansion in 2025 [39][40] - The refill rates for Venoprazan are tracking similarly to those of traditional PPIs, indicating strong patient retention [27][28] - The market for H. Pylori treatment is limited, with under 1 million patients treated annually, but Phathom is actively engaging prescribers in this area [44][45] Conclusion Phathom Pharmaceuticals is positioned for growth with its innovative product Venoprazan, backed by strong clinical data and a solid commercial strategy. The company is actively addressing regulatory challenges while exploring new market opportunities, including EOE and OTC formulations. The upcoming years are critical for the company's trajectory, particularly in resolving exclusivity issues and expanding its market presence.