Vanda Pharmaceuticals FY Conference Summary Company Overview - Vanda Pharmaceuticals is a global biopharmaceutical company focused on innovative therapies with a strong commercial portfolio anchored by four FDA-approved brands: Fanapt, Hetlioz, Ponvory, and Nereus [2][3] Core Products and Pipeline - **Fanapt**: An atypical antipsychotic approved for bipolar I disorder and schizophrenia. A long-acting injectable formulation is in phase three for schizophrenia, and a program for hypertension has been initiated [4][5] - **Hetlioz**: Approved for non-24-hour sleep-wake disorder and other sleep disturbances. It is at the regulatory stage for insomnia and jet lag disorder [6][7] - **Ponvory**: Approved for relapsing forms of multiple sclerosis, with ongoing phase three programs for psoriasis and ulcerative colitis [6][7] - **Nereus**: Recently approved for motion sickness, with potential applications in GLP-1 induced nausea and vomiting, and gastroparesis [6][7][10] Financial Performance - For Q3 2025, Vanda reported revenue of $56.3 million, with contributions from Fanapt ($31 million), Hetlioz ($18 million), and Ponvory ($7 million). The company expects total revenue for 2025 to be between $210 million and $230 million [21][22] Strategic Focus - The company aims to grow and diversify revenue by expanding existing products and introducing new ones, targeting six commercial products by the end of 2026 [3][4] - Upcoming regulatory catalysts include Bysanti's PDUFA date on February 21, 2026, and the initiation of phase three programs for GLP-1 induced vomiting [7][10] Market Opportunities - **Nereus**: The motion sickness market has approximately 30% of adults in the U.S. experiencing symptoms, translating to a potential patient population of around 12 million. The GLP-1 market, valued at over $50 billion, presents a significant opportunity for Nereus as an adjunct treatment [11][12][35] - **Bysanti**: Expected to extend the psychiatry portfolio, especially with a potential indication for major depressive disorder (MDD), which could open treatment options for an additional 20 million patients [15][31] Commercialization Strategy - Vanda has a robust sales force of around 300 reps, primarily targeting psychiatrists, but plans to expand efforts to include primary care physicians for Bysanti [26][28] - The company anticipates a transition strategy from Fanapt to Bysanti, leveraging existing resources to maintain revenue streams post-Fanapt's expected loss of exclusivity around 2027 [28][29] R&D Milestones - Nereus's approval for motion sickness was a significant milestone, with a commercial launch expected in the second half of 2026. The company is also pursuing additional indications for its products [7][10] - Imsidolimab, targeting generalized pustular psoriasis, is under priority review with a potential launch in summer 2026 [17][37] Conclusion - Vanda Pharmaceuticals is positioned for significant growth with a strong pipeline and strategic focus on expanding its product offerings. The upcoming regulatory milestones and market opportunities in motion sickness and the GLP-1 space are key drivers for future revenue growth [39]

Financial Data and Key Metrics Changes - The third quarter results indicate strong progress in transforming Kimberly-Clark into an industry-leading personal care company, with consistent operating margin expansion and industry-leading productivity [4][5] - The company achieved its seventh consecutive quarter of volume plus mix-led growth, despite challenges in the broader consumer packaged goods (CPG) industry [4][5] Business Line Data and Key Metrics Changes - In North America, Kimberly-Clark gained 10 basis points of market share in diapers during the third quarter, with a year-to-date increase of 90 basis points [9][10] - The promotional activity in North America is lower than pre-2019 levels, with a focus on driving trial for innovation [10][11] Market Data and Key Metrics Changes - The company is experiencing double-digit growth in the club channel, which is positively impacting its business [12][13] - Digital channels accounted for 100% of growth in North America, with a significant share benefit compared to brick-and-mortar [39][40] Company Strategy and Development Direction - Kimberly-Clark's strategy is centered on innovation-led growth, focusing on improving products across the good, better, best spectrum [8][10] - The company aims to achieve a gross margin of at least 40% and an operating profit of 18%-20% by the end of the decade [28][29] Management's Comments on Operating Environment and Future Outlook - Management noted that consumer purchasing power is under pressure, but demand for essential categories remains resilient [47][48] - The company is confident in its ability to mitigate stranded costs from the IFB transaction and expects to see a step-up in growth in adjusted EPS from continuing operations [28][29] Other Important Information - The company is working to stabilize fiber costs through a joint venture with Suzano, which is expected to reduce volatility in input costs [74][76] - The transition to integrated margin management is helping the company proactively manage cost volatility [76][77] Q&A Session Summary Question: Update on competitive dynamics in U.S. diapers - Management acknowledged increased competitive activity but noted solid performance and market share gains in diapers [8][9] Question: Shape of the P&L in 2026 and 2027 - Management indicated it is premature to provide specifics but highlighted targets for organic growth and operating profit consistent with long-term algorithms [26][28] Question: Performance gap in North America - Management explained that the gap was due to hurricane-related shipment impacts and timing of promotional expenses [37][38] Question: Promotional activity and margin implications - Management stated that promotional activity is a tactic to drive trial and that gross margins are expected to expand in Q4 [51][52] Question: Full 2025 guidance and top-line expectations - Management expects to grow in line with category growth and anticipates an acceleration in Q4 [60][62] Question: Competition in the ultra-premium diaper segment - Management expressed confidence in competing through innovation and premiumization strategies [69][70]