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]

Financial Data and Key Metrics Changes - The company reported net revenue of $239.5 million for Q3 2025, representing a 29% year-over-year growth [5][20] - Cash generation was robust at $106 million, bringing the total cash and cash equivalents to $778 million as of September 30, 2025 [5][22] - Non-GAAP adjusted net income for Q3 2025 was $63.5 million, or $1.8 per diluted share, compared to $57.3 million, or $0.99 per diluted share in the prior year quarter [21][22] Business Line Data and Key Metrics Changes - The WCAGX product line achieved an average of 8,100 patients by the end of Q3, with a record increase of approximately 500 new patients added during the quarter [9][10] - The company raised its full-year revenue guidance from $820 million to a range of $845 million to $865 million, reflecting strong demand for WCAGX [12][23] Market Data and Key Metrics Changes - The company noted that WCAGX is rapidly approaching blockbuster status, with expectations of exceeding $1 billion in annual revenue from narcolepsy alone [6][25] - The company has secured important new payer coverage wins, which continue to expand its already broad payer coverage [11] Company Strategy and Development Direction - The company aims to become a leading patient-focused CNS company, delivering innovative treatments for unmet medical needs [7] - The late-stage pipeline includes multiple catalysts, with plans to initiate two Phase III trials for Pitolacin HD by the end of 2025 [6][14] - The company is focused on strategic business development to enhance its pipeline and product portfolio [46][67] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued growth trajectory, driven by strong fundamentals and execution across the organization [12][113] - The company anticipates ongoing investments in R&D to advance its late-stage pipeline, with five Phase III registrational programs expected by year-end [23][24] Other Important Information - The company has filed utility patents for both Pitolacin GR and HD, securing potential exclusivity until 2044 [16][76] - The IND for Pitolacin HD has been submitted to the FDA, with target PDUFA dates set for 2028 [14][16] Q&A Session Summary Question: Can you elaborate on the trajectory of WCAGX evolving into 2026? - Management noted that the performance is driven fundamentally by patient adds, with a record increase of 500 patients in Q3, and strong fundamentals are expected to carry forward into Q4 and 2026 [30][33] Question: What were the GI AEs seen with the GR formulation? - No new safety or tolerability issues were observed with the Pitolacin GR formulation, and all patients were able to initiate treatment at the therapeutic dose without issues [35][36] Question: What are the current thoughts on business development and M&A? - The company remains focused on strategic business development, actively evaluating several opportunities to enhance its pipeline [46][67] Question: How is new patient growth coming from? - New patient growth is primarily from deeper penetration within existing prescribers, with a stable breakdown of NT1 and NT2 patients [120][97] Question: Can you discuss the EPX-100 epilepsy program? - The company is excited to share efficacy data at the upcoming American Epilepsy Society meeting and continues to recruit patients for ongoing studies [87][88]

Financial Data and Key Metrics Changes - Harmony Biosciences reported net revenue of $239.5 million for Q3 2025, representing a 29% year-over-year growth [5][20] - The company raised its full-year net revenue guidance from $820-$860 million to $845-$865 million [5][22] - Cash generation for the quarter was robust at $106 million, bringing total cash and cash equivalents to $778 million as of September 30, 2025 [5][21] Business Line Data and Key Metrics Changes - Wakix achieved net sales of $239.5 million in Q3 2025, with an average increase of 500 patients added, resulting in approximately 8,100 average patients by the end of Q3 [9][20] - The performance of Wakix is attributed to its unique position as the only non-scheduled treatment option, leading to high brand awareness and broad payer coverage [9][10] Market Data and Key Metrics Changes - The company is rapidly approaching blockbuster status for Wakix in narcolepsy, with expectations of exceeding $1 billion in annual revenue from this indication alone [6][11] - The market for narcolepsy treatments is expected to expand with the introduction of new therapies, but Harmony remains confident in Wakix's continued growth [45][46] Company Strategy and Development Direction - Harmony aims to become a leading patient-focused CNS company, focusing on innovative treatments for unmet medical needs [7][8] - The company has a robust late-stage pipeline with multiple catalysts expected in the coming years, including the initiation of two phase 3 trials for Pitolisant HD [7][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's growth trajectory, driven by strong fundamentals and execution across the organization [24][91] - The management team highlighted the importance of maintaining a profitable, self-funding biotech profile while pursuing strategic opportunities to enhance the product portfolio [8][22] Other Important Information - The IND for Pitolisant HD has been submitted to the FDA, with plans to initiate phase 3 trials for both narcolepsy and idiopathic hypersomnia by the end of 2025 [7][14] - The company is actively evaluating business development opportunities to expand its pipeline and product offerings [43][44] Q&A Session Summary Question: Can you elaborate on the trajectory of Wakix evolving into 2026? - Management noted that the strong performance is driven by patient adds, with a record increase of 500 patients in Q3, and they expect this momentum to continue into Q4 and 2026 [27][30] Question: What were the GI AEs seen with the GR formulation? - No new safety or tolerability issues were observed with the Pitolisant GR formulation, and all patients initiated treatment at the therapeutic dose without issues [34][35] Question: Thoughts on BizDev and M&A after the Zygel failure? - The company remains focused on strategic business development, actively evaluating innovative assets to enhance its pipeline [42][43] Question: How is new patient growth coming for Wakix? - Growth is attributed to both activating new prescribers and deeper penetration within existing writers, supported by strong marketing and promotional efforts [90]

Core Insights - Viatris (VTRS) has acquired Tokyo-based Aculys Pharma, focusing on enhancing its Central Nervous System (CNS) portfolio and expanding its presence in Japan and the Asia-Pacific region [1][3][6] Acquisition Details - The acquisition involves an undisclosed upfront payment to Aculys Pharma's shareholders, with additional payments linked to regulatory and commercial milestones, as well as royalties based on net sales [2] - Viatris has secured exclusive rights to develop and commercialize pitolisant and Spydia (diazepam nasal spray) in Japan and select Asia-Pacific markets [1][6][7] Product Information - Pitolisant is a selective/inverse agonist of the histamine H3 receptor, with plans for marketing approval in Japan by the end of 2025 for treating excessive daytime sleepiness (EDS) and cataplexy in narcolepsy patients [4][9] - Spydia, approved in June 2025 in Japan, is the first intranasal anti-seizure medication for status epilepticus, addressing unmet needs in neurological emergencies [7][8] Strategic Rationale - The acquisition aims to leverage Viatris' commercial infrastructure and CNS expertise, aligning with its strategy to grow in high-impact therapeutic areas [9][10] - This move complements Viatris' existing innovative portfolio in Japan, which includes products for various conditions, thereby positioning the company for near- and mid-term growth [10]

Core Viewpoint - The stock market is expected to see a shift from large-cap dominance to a focus on high-growth midcap stocks in the latter part of 2025, with potential changes in interest rates and inflation impacting investor sentiment [2][27]. Group 1: Stock Recommendations - Five stocks are highlighted for September 2025, characterized by optimistic outlooks, positive cash flow, and manageable debt levels [3]. - The stocks are ranked by market capitalization, with detailed metrics provided for each [3]. Group 2: Monday.com Ltd. (MNDY) - Expected EPS growth for Monday.com is over 25%, with a price target upside above 35% [4]. - The stock price is currently $193, with an expected EPS of $0.62 for 2024 and a projected growth of 550.4% this year [5]. - The company has a positive free cash flow and a debt/free cash flow ratio under 2, indicating strong financial health [4]. Group 3: Wix.com Ltd. (WIX) - Wix.com has a strong buy rating from eight analysts, with an average price target of $214.84 and a consensus EPS target of $6.92 for 2025, up from $2.36 in 2024 [11]. - The company has seen free cash flow grow from $32 million in 2022 to $488 million in 2024, driven by increased demand for its services [11]. Group 4: Dolby Laboratories (DLB) - Dolby has a strong buy rating from two analysts, with an average price target of $102.25 and a consensus EPS target of $4 for fiscal 2025, up from $2.69 in fiscal 2024 [14]. - The company reported $68 million in operating cash flow in the last quarter and has $777 million in cash and investments on its balance sheet [15]. Group 5: Krystal Biotech (KRYS) - Krystal Biotech is rated a strong buy by seven analysts, with an average price target of $204.90 and a consensus EPS target of $5.06 for 2025, up from around $3 in 2024 [20]. - The company estimates a global market opportunity for its product Vyjuvek exceeding $1 billion, with plans for expansion into various markets [21]. Group 6: Harmony Biosciences Holdings (HRMY) - Harmony Biosciences has a strong buy rating from five analysts, with an average price target of $55.33 and a consensus EPS expectation of $3.21 for 2025, up from $2.51 in 2024 [24]. - The company's flagship product, Wakix, generated $714.7 million in sales for 2024, reflecting a 20% annual gain [25].

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.

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].

Financial Data and Key Metrics Changes - The company reported full-year guidance of $820 million to $860 million, with Q1 sales of approximately $185 million, reflecting a 20% growth [5][6] - The company expects to approach 8,000 patients on therapy by the end of the year, indicating strong patient growth momentum [6][9] Business Line Data and Key Metrics Changes - The core commercial franchise in Wakix for narcolepsy continues to grow, with consistent quarter-over-quarter growth over the past five years [6][11] - The pipeline includes three orphan rare CNS franchises with eight assets across 13 development programs, four of which are in Phase III, with potential for up to two new product launches each year over the next three to four years [3][4] Market Data and Key Metrics Changes - The company sees a significant market opportunity with approximately 80,000 diagnosed patients for narcolepsy, with only about 7,300 currently on therapy [8][11] - The company is targeting a patient population of around 9,000 to achieve over $1 billion in sales for narcolepsy [8][9] Company Strategy and Development Direction - The company is focused on expanding its commercial execution and tapping into the sizable market opportunity for narcolepsy treatments [11] - The introduction of next-generation formulations, such as the gastro-resistant and high-dose formulations, is part of the strategy to enhance the Wakix franchise [16][19] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the continued strong commercial execution and the potential for significant growth in the narcolepsy market [11][12] - The company is optimistic about its late-stage pipeline and the potential for new product launches, which could drive future revenue growth [3][4] Other Important Information - The company recently settled patent suits with generic filers, with an entry date for generics set for January 2030, and is on track to gain pediatric exclusivity [31][32] - The company acquired Zynerva for $60 million, which includes a promising asset for treating Fragile X syndrome, with Phase III results expected in the third quarter [35][36] Q&A Session Summary Question: What is the patient growth trajectory for the full year? - The company expects continued strong patient growth, aiming for about 8,000 patients by year-end, with a consistent growth pattern observed over the last five years [6][9] Question: What are the expectations for the new Chief Commercial Officer? - The new Chief Commercial Officer brings 25 years of experience and is expected to validate and enhance the current successful commercial strategy without major changes [12][15] Question: What is the timeline for the new formulations in the pipeline? - The gastro-resistant formulation is on track for a pivotal bioequivalence study readout in Q3, with a target PDUFA date in 2026 [18][19] Question: How does the company plan to differentiate its new products in the market? - The company aims to demonstrate meaningful clinical improvements in symptoms such as excessive daytime sleepiness and fatigue, which are prevalent in narcolepsy patients [22][29] Question: What is the status of the patent suits and expected entry of generics? - The company has settled with several generic filers, with the first entry date for generics set for January 2030, and is working on settling with remaining parties [31][32] Question: What are the next steps following positive Phase III data for Fragile X syndrome? - If positive data is achieved, the company plans to engage with the FDA for NDA submission and explore additional indications such as 22q deletion syndrome [48][49]

Financial Data and Key Metrics Changes - Harmony Biosciences reported net product revenue of $184.7 million for Q1 2025, representing a 20% increase year-over-year from $154.6 million in Q1 2024 [35][36] - Non-GAAP adjusted net income for Q1 2025 was $60.4 million, or $1.03 per diluted share, compared to $50.7 million, or $0.88 per diluted share in the prior year quarter, reflecting a growth of 19% [36][34] - The company ended Q1 2025 with over $600 million in cash and cash equivalents, positioning it well for future growth and pipeline development [34][36] Business Line Data and Key Metrics Changes - The core commercial business, particularly Wakix for narcolepsy, continues to show strong growth, achieving a 20% year-over-year increase in net revenue [20][21] - The company is on track to reach over $1 billion in revenue from narcolepsy alone, with a confirmed net revenue guidance for 2025 in the range of $820 million to $860 million [22][36] - The pipeline includes eight assets across 13 development programs, with plans to have up to six programs in Phase III trials by the end of 2025 [10][24] Market Data and Key Metrics Changes - Harmony's market penetration for Wakix has reached over 50% among approximately 5,000 healthcare providers, with continued growth in prescribers beyond those enrolled in the oxybate REMS program [21][22] - The company is actively monitoring the competitive landscape, particularly with the introduction of generic alternatives to oxybate, but has not seen significant changes in payer coverage for Wakix [56][57] Company Strategy and Development Direction - Harmony aims to leverage its strong balance sheet to expand its late-stage pipeline, focusing on rare neurological diseases with high unmet medical needs [12][13] - The company is preparing for significant clinical milestones, including the Phase III trial of ZYN-two for Fragile X syndrome, with top-line data expected in Q3 2025 [8][30] - Harmony's operational foundation is U.S.-based, which provides a unique advantage in navigating potential geopolitical risks and supply chain challenges [15][13] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver continued growth, driven by a robust pipeline and strong commercial performance [16][38] - The company is optimistic about the potential for new product launches and indications over the next several years, with peak sales potential exceeding $3 billion [16][38] - Management highlighted the importance of patient-centric drug development and the ongoing commitment to addressing unmet medical needs in neurology [23][24] Other Important Information - The company has made significant progress in its clinical development programs, with a focus on addressing symptoms such as fatigue in narcolepsy, which currently lacks approved treatments [25][68] - Harmony's unique commercial model and differentiated product profile for Wakix continue to drive its success in the narcolepsy market [10][21] Q&A Session Summary Question: What are the powering assumptions for the ZYN-two study and risk mitigation strategies? - The ZYN-two study is powered more than 90% for the primary endpoint, with rigorous criteria for patient selection and extensive training for caregivers to ensure accurate assessments [40][42] Question: What changes or tweaks might be implemented in the commercial strategies for Wakix? - The new Chief Commercial Officer expressed excitement about the existing strategies and emphasized a focus on maintaining strong performance while preparing for future opportunities [41][48] Question: How does Harmony view the competitive landscape for orexin receptor agonists? - Harmony sees the market as still emerging, with a belief that narcolepsy will remain a polypharmacy market, necessitating multiple treatment options for patients [50][68] Question: What are the drivers of revenue guidance for 2025? - The primary driver of growth is the continued sequential addition of patients on therapy, with a strong and stable progression of average patients on Wakix [73][75] Question: How quickly could Harmony file an NDA for ZYN-two if data is positive? - If the results are positive, Harmony aims to file the NDA as soon as possible, anticipating a priority review due to the significant unmet need in the Fragile X patient population [86][90]

Financial Data and Key Metrics Changes - The company reported net revenues of $184.7 million for Q1 2025, representing a 20% increase year-over-year from $154.6 million in Q1 2024 [35][36] - Non-GAAP adjusted net income for Q1 2025 was $60.4 million, or $1.03 per diluted share, compared to $50.7 million, or $0.88 per diluted share in the prior year quarter, reflecting a growth of 19% [37][38] - The company ended Q1 2025 with over $610 million in cash, cash equivalents, and investments on the balance sheet [39] Business Line Data and Key Metrics Changes - Net product revenue for Wakix in Q1 2025 was $184.7 million, a 20% increase year-over-year, indicating strong demand in the narcolepsy market [7][19] - The company is confident in reaching over $1 billion in revenue from narcolepsy alone, with guidance for total net revenue in 2025 set between $820 million and $860 million [21][39] Market Data and Key Metrics Changes - The company has achieved over 50% penetration within approximately 5,000 healthcare providers (HCPs) as of the end of Q1 2025, with continued growth in prescribers beyond those enrolled in the oxybate REMS program [20][21] - The narcolepsy market is estimated to have around 80,000 diagnosed patients, with the company tapping into this potential through its differentiated product profile [21][80] Company Strategy and Development Direction - The company aims to leverage its strong balance sheet to build a robust late-stage pipeline, with plans to have up to six programs in Phase III trials by the end of 2025 [9][12] - The focus is on developing next-generation formulations of pitolisant, targeting unmet patient needs and extending the growth of the pitolisant franchise into the mid-2040s [21][22] - The company is also exploring opportunities in adjacent rare CNS assets to further strengthen its pipeline [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to navigate the shifting geopolitical landscape and potential impacts from new tariffs, emphasizing operational independence [12][14] - The company is optimistic about its late-stage pipeline, with expectations of delivering one or more new product or indication launches each year over the next several years, with peak sales potential exceeding $3 billion [15][40] Other Important Information - The company has a unique operational foundation in the U.S., with exclusive licensing rights and intellectual property associated with its products domiciled in the U.S. [14] - The company is actively working on a secondary manufacturing site for Wakix in the U.S. to enhance supply chain resilience [12] Q&A Session Summary Question: What are the powering assumptions for the ZYN-two study and risk mitigation strategies? - The study is powered more than 90% for the primary endpoint, with rigorous criteria and checks in place to ensure the right patients are included [42][45][46] Question: What are the initial impressions of the commercial team and strategies supporting Wakix? - The new Chief Commercial Officer expressed excitement about the team's focus on patient needs and the strong performance of Wakix, with plans to evaluate and implement potential improvements [43][49][51] Question: How does the company view the competitive landscape for orexin receptor agonists? - The company sees the market as still emerging, with a focus on the high potency of its BP1.5205 compound and the potential for polypharmacy in treating narcolepsy [53][57][70] Question: What are the drivers of revenue guidance for 2025? - Continued sequential additions of patients on therapy and strong underlying business fundamentals are expected to drive revenue growth [75][78] Question: What is the timeline for filing the NDA for ZYN-two if positive data is obtained? - The company aims to file the NDA as soon as possible following positive data, with expectations for priority review due to the significant unmet need [87][91]