Summary of Alkermes Conference Call Company Overview - **Company**: Alkermes - **Event**: 2026 TD Cowen Healthcare Conference - **Key Speaker**: Richard Pops, Chairman and CEO Industry Focus - **Primary Industry**: Sleep Medicine - **Key Products**: Alixorexton, LUMRYZ, Avadel acquisition Core Points and Arguments 1. **Business Transition**: Alkermes has undergone significant changes in 2025, solidifying its position in the sleep medicine market, particularly with the orexin franchise and the acquisition of Avadel [2][3] 2. **Market Position**: The company is now a major player in the sleep medicine market, preparing for the launch of alixorexton, supported by a strong and cash-generative base business [3] 3. **Acquisition Rationale**: The acquisition of Avadel was strategic, enhancing the company's presence in sleep centers and preparing for the alixorexton launch, which is expected to shift the launch curve positively [4][7] 4. **Unmet Needs in Narcolepsy**: There is a significant gap between the prevalence of narcolepsy (approximately 200,000 patients in the U.S.) and those treated (about 80,000), indicating a large market opportunity [15] 5. **Orexin Compounds**: The company is investigating the ideal dosing for orexin agonists, with promising data from Phase 2 studies indicating safety and efficacy [17][18] 6. **Phase 3 Program**: Alkermes is initiating a Phase 3 program with three studies focused on NT-1 and NT-2, with primary endpoints including the Maintenance of Wakefulness Test (MWT) and Epworth Sleepiness Scale (ESS) [24][25] 7. **Cognitive and Fatigue Outcomes**: The company has observed significant improvements in cognitive complaints and fatigue in patients, which are critical for treatment success [56][57] Additional Important Content 1. **Base Business Strength**: Alkermes has transformed from a royalty-based business to a proprietary products business, with expectations of $1.4 billion from proprietary products in 2026 [59][60] 2. **Commercial Strategy**: The acquisition of Avadel is expected to broaden the commercial portfolio and increase profitability, allowing for aggressive investment in the pipeline [60][61] 3. **Future Opportunities**: Alkermes is exploring additional indications for orexin drugs, including ADHD and fatigue, with initial proof of concept data expected soon [46][48] 4. **Side Effect Profile**: The orexin compounds have a mild to moderate side effect profile, with insomnia being the most common, which tends to diminish over time [39][40] 5. **Business Development**: The company is open to tuck-in business development deals that leverage its clinical and scientific capabilities but is currently focused on executing its late-stage and earlier-stage programs [63][64] This summary encapsulates the key points discussed during the conference call, highlighting Alkermes' strategic direction, market opportunities, and product development plans.

Financial Data and Key Metrics Changes - Jazz Pharmaceuticals reported record total revenue of $4.3 billion for 2025, reflecting a 5% growth over 2024, with fourth quarter revenue of $1.2 billion, a 10% year-over-year increase [6][31] - Non-GAAP adjusted net income for 2025 was approximately $522 million, with non-GAAP adjusted EPS of $8.38 [31] - The company expects total revenue for 2026 to be in the range of $4.25 billion to $4.50 billion, indicating a growth of about 2.5% at the midpoint compared to 2025 [32] Business Line Data and Key Metrics Changes - The rare sleep therapeutic area generated over $2 billion in total revenue in 2025, with XYWAV revenue growing 12% to approximately $1.7 billion for the year [12][31] - Epidiolex achieved blockbuster status with $1.1 billion in revenue, up 9% year-over-year, while Zepzelca generated $307 million in revenue in 2025 [16][21] - Modeyso, launched in August 2025, generated $48 million in revenue by year-end, with expectations of peak sales exceeding $500 million in the U.S. [19][31] Market Data and Key Metrics Changes - XYWAV remains the number one branded treatment for narcolepsy and the only FDA-approved treatment for idiopathic hypersomnia (IH), with a 34% increase in net active IH patients [14][15] - The introduction of multiple generic high-sodium oxybate products is expected to negatively impact revenues from high-sodium Xyrem, while XYWAV is anticipated to maintain its market position due to its unique low-sodium profile [15][32] - The company expects a modest decrease in total rare sleep revenue for 2026, primarily driven by Xyrem and Hikma Pharmaceuticals revenue [32] Company Strategy and Development Direction - Jazz Pharmaceuticals is sharpening its strategic focus on rare diseases, aiming to strengthen current franchises and expand into new areas [8][39] - The company plans to leverage its proven capabilities in corporate development to continue building a more valuable company, with a focus on rare disease therapies [9][39] - Future pipeline advancements and new business development transactions are anticipated, particularly in the oncology space with zanidatamab and Ziihera [10][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong financial position and operational excellence, highlighting the successful launch of innovative therapies and regulatory approvals [5][39] - The management team acknowledged the evolving competitive landscape in the sleep market but emphasized the unique safety benefits of XYWAV, which resonate well with patients and healthcare providers [48][75] - The company is optimistic about the potential for zanidatamab to become the HER2-targeted agent of choice across multiple tumor types, with a potential launch in the second half of 2026 [24][25] Other Important Information - The company resolved nearly all major litigation, including settling outstanding ANDA litigation for Epidiolex, which extends its market runway into the late 2030s [7][8] - Jazz Pharmaceuticals generated approximately $1.4 billion of cash from operations for the full year 2025, ending the year with $2.4 billion in cash and investments [38] Q&A Session Summary Question: Guidance around XYWAV for 2026 - Management indicated that XYWAV is well-positioned for 2026, with growth expected primarily from the IH segment, despite potential competitive pressures from generics in the second half of the year [41][44] Question: Hikma royalty rate and AG volume impact - Management confirmed a modest step down in the Hikma royalty rate for 2026 but emphasized that significant economics will still flow to Jazz Pharmaceuticals [50][51] Question: JZP047 background and development - Management clarified that JZP047 is a novel chemical entity developed in-house, with strong preclinical data supporting its use in absence epilepsy [54][55] Question: HER2 breast cancer population and potential uptake - Management noted approximately 150,000 patients with HER2-positive breast cancer in the markets served, positioning zanidatamab as a potential treatment option in the post-HER2 setting [57][58] Question: XYWAV competitive pressure in the second half - Management expects minimal impact on XYWAV in the first half of 2026, with increasing competitive dynamics anticipated in the second half due to generics and new wake-promoting agents [66][68] Question: Payer contracts and potential negotiations - Management acknowledged the possibility of payers wanting to renegotiate contracts if generics gain significant market volume, but emphasized the unique value proposition of XYWAV [71][73] Question: Launch metrics for Idacio and ACTION study impact - Management expressed confidence in the early launch metrics for Idacio, with the $500 million peak sales opportunity contingent on the success of the ACTION study [79][82]

Financial Data and Key Metrics Changes - Jazz Pharmaceuticals reported record total revenue of $4.3 billion for 2025, reflecting a 5% growth over 2024, with fourth quarter revenue of $1.2 billion, representing a 10% year-over-year growth [6][31] - Non-GAAP adjusted net income for 2025 was approximately $522 million, with non-GAAP adjusted EPS of $8.38 [31] - The company expects total revenue for 2026 to be in the range of $4.25 billion to $4.50 billion, equating to a growth of about 2.5% at the midpoint compared to 2025 [32] Business Line Data and Key Metrics Changes - The rare sleep therapeutic area generated over $2 billion in total revenue in 2025, with XYWAV revenue growing 12% to approximately $1.7 billion for the year [12][31] - Epidiolex achieved blockbuster status with $1.1 billion in revenue, up 9% year-over-year, while Zepzelca generated $307 million in revenue in 2025 [16][21] - Modeyso, launched in August 2025, generated $48 million in revenue by year-end, indicating strong early performance [19] Market Data and Key Metrics Changes - XYWAV remains the number one branded treatment for narcolepsy and the only FDA-approved treatment for idiopathic hypersomnia (IH), with a 34% increase in net active IH patients [14][15] - The competitive landscape for sleep medications is evolving, with two generic versions of high-sodium Xyrem entering the market, expected to negatively impact revenues [15][32] - The company anticipates a modest decrease in rare sleep revenue for 2026, primarily driven by Xyrem and Hikma Pharmaceuticals revenue [32] Company Strategy and Development Direction - Jazz Pharmaceuticals is sharpening its strategic focus on rare diseases, aiming to strengthen current franchises and expand into new areas [8][39] - The company plans to leverage its proven capabilities in corporate development to continue building a more valuable company, particularly in rare diseases [9][39] - Future pipeline advancements and new business development transactions are expected to align with the company's rare disease focus [8] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's strong financial position and operational excellence, highlighting the potential for significant future growth [5][39] - The company is focused on maximizing the potential of its oncology portfolio, particularly with zanidatamab and its upcoming launch in GEA [10][24] - Management acknowledged the evolving competitive landscape in the sleep market but emphasized the unique value proposition of XYWAV as a low-sodium option [68][75] Other Important Information - The company resolved nearly all major litigation, including settling outstanding ANDA litigation for Epidiolex, which extends its runway into the late 2030s [7][8] - Jazz Pharmaceuticals generated approximately $1.4 billion of cash from operations for the full year 2025, ending the year with $2.4 billion in cash and investments [38] Q&A Session Summary Question: Guidance around XYWAV for 2026 - Management indicated that XYWAV is well-positioned with strong patient adds and unique safety benefits, but acknowledged potential competitive pressures from generics in the second half of 2026 [41][44] Question: Hikma royalty rate and AG volume impact - Management confirmed a modest step down in the Hikma royalty rate for 2026 but emphasized that significant economics will still flow to Jazz [50][51] Question: JZP047 background and development - Management clarified that JZP047 is a novel chemical entity developed in-house, focusing on absence epilepsy, with strong preclinical data supporting its development [54][55] Question: HER2 breast cancer population and potential uptake - Management highlighted the opportunity for zanidatamab in the HER2-positive breast cancer market, estimating around 150,000 patients in the served markets [57][58] Question: XYWAV competitive pressure in the second half - Management expects minimal impact on XYWAV in the first half of 2026 but anticipates increasing competitive dynamics in the second half due to generics and new agents [66][68] Question: Payer contracts and potential negotiations - Management acknowledged the possibility of payers wanting to renegotiate contracts but emphasized the strong commitment from healthcare providers to ensure access to XYWAV [71][74] Question: Future strategy for the sleep-wake franchise - Management stated that they are investing in the growth of all current franchises, including sleep, and are open to opportunities for licensing and M&A to augment growth [85][88]

Financial Data and Key Metrics Changes - Jazz Pharmaceuticals achieved record total revenue of $4.3 billion in 2025, reflecting a 5% growth over 2024, with fourth quarter revenue of $1.2 billion, representing a 10% year-over-year growth [4][30] - Non-GAAP adjusted net income for the full year 2025 was approximately $522 million, with non-GAAP adjusted EPS of $8.38 [30] Business Line Data and Key Metrics Changes - The rare sleep therapeutic area generated over $2 billion in total revenue in 2025, with XYWAV revenue growing 12% to approximately $1.7 billion for the year [11] - Epidiolex achieved blockbuster status with $1.1 billion in revenue, up 9% year-over-year, while Zepzelca generated $307 million in revenue in 2025, with a 15% year-over-year growth in the fourth quarter [14][20] - Modeyso generated $48 million in revenue from its launch in August 2025, indicating strong early performance [18] Market Data and Key Metrics Changes - XYWAV remains the number one branded treatment for narcolepsy and the only FDA-approved treatment for idiopathic hypersomnia (IH), with a 34% increase in net active IH patients in 2025 [12] - The introduction of two generic versions of high-sodium Xyrem is expected to negatively impact revenues, particularly in the second half of 2026 [13][31] Company Strategy and Development Direction - The company is sharpening its strategic focus on rare diseases, aiming to strengthen current franchises and expand into new areas, supported by a strong financial position [6][9] - Jazz Pharmaceuticals plans to leverage its proven track record in corporate development to continue building a more valuable company, with a focus on rare disease and oncology [8][38] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the future, highlighting the potential launch of zanidatamab in GEA and sustained execution for Modeyso and Zepzelca [9][38] - The company anticipates double-digit growth in rare oncology and epilepsy revenues in 2026, driven primarily by Epidiolex, Modeyso, and Ziihera [31] Other Important Information - The company resolved nearly all major litigation, including settling outstanding ANDA litigation for Epidiolex, which extends its runway into the late 2030s [5] - Jazz Pharmaceuticals sold its priority review voucher for $200 million, with half of the proceeds flowing to the company [8] Q&A Session Summary Question: Guidance around XYWAV for 2026 - Management indicated that XYWAV is expected to be flat or grow mid-single digits, with potential payer contracting concessions impacting guidance [40][42] Question: Hikma royalty rate and AG volume impact - Management noted a modest step down in the Hikma royalty rate for 2026, but significant economics will still flow to Jazz [49][50] Question: JZP047 background and development - JZP047 is a novel chemical entity developed in-house, focusing on absence epilepsy, with strong preclinical data supporting its development [53][54] Question: HER2 breast cancer population and potential uptake - Management highlighted approximately 150,000 patients with HER2-positive breast cancer, positioning zanidatamab as a potential treatment in the post HER2 setting [56][57] Question: Competitive pressure on XYWAV - Management expects minimal impact on XYWAV in the first half of 2026, with increasing competitive dynamics anticipated in the second half [65][66]