Viatris(VTRS) - 2025 Q3 - Earnings Call Transcript

Financial Data and Key Metrics Changes - Total revenues for Q3 2025 were $3.76 billion, down approximately 1% year-over-year. Excluding the impact from Indore, operational revenue growth was approximately 1% compared to the prior year [25][26] - Adjusted gross margin for the quarter was 56%, in line with expectations, but impacted by the Indore situation [27] - Free cash flow generated in the quarter was $658 million, with an adjusted figure of $728 million excluding transaction-related costs [28] Business Line Data and Key Metrics Changes - In developed markets, net sales decreased by 5%, primarily due to the Indore impact. However, the generics business grew by 5% year-over-year, driven by new product revenues in key markets like France and Italy [25][26] - The North America business saw a 12% decrease year-over-year, mainly due to the Indore impact and competition on certain generic products. Despite this, double-digit growth was observed in products like Breyna and Yupelri [26] - Emerging markets experienced a 7% increase in net sales, driven by established brands in key markets such as Turkey and Mexico [26] Market Data and Key Metrics Changes - In Japan, net sales decreased by approximately 9% due to government price regulations and changes in reimbursement policy affecting off-patent brands [26] - Greater China saw net sales exceed expectations with a growth of 9%, attributed to a diversified commercial model and increased demand for brands sensitive to patient choice [27] Company Strategy and Development Direction - The company is focusing on three key areas for sustained growth: a global generics business evolving towards higher-margin complex products, an established brands business strengthened by adding new brands, and an innovative brands business expanding through late-stage or in-market growth assets [5][6] - The strategic review aims to identify operating efficiencies across various functions, including sales, marketing, R&D, and supply chain, with an expectation of delivering meaningful net cost savings over a multi-year period [4][5] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the fundamentals of the business, anticipating continued momentum into 2026. They are raising full-year guidance for total revenues, adjusted EBITDA, and adjusted EPS [7][30] - The company plans to provide a detailed outlook for 2026 in the first quarter of next year, considering factors such as product approvals, competitive dynamics, and potential loss of exclusivity for certain products [31][73] Other Important Information - The company has returned over $920 million to shareholders year-to-date, including $500 million in share repurchases, and is on track to return over $1 billion for the year [10][29] - The acquisition of Aculis in Japan adds innovative CNS assets to the portfolio, enhancing the company's presence in a strategically important market [10][29] Q&A Session Summary Question: Update on the Indore resolution situation - Management reported significant progress in remediation at the Indore facility and a productive meeting with the FDA regarding reinspection timing, which remains uncertain [35][36] Question: Performance of EpiPen and Lipitor - EpiPen's market share remains stable at around 24-25%, with strong growth in Europe and a relaunch in Canada contributing to performance [37][38] Question: Feedback from FDA on fast-acting meloxicam - The company is optimistic about obtaining opioid-sparing language in the product label and has a pre-NDA meeting scheduled with the FDA [42][43] Question: Capital allocation priorities for 2026 - The company aims for a balanced approach in capital allocation, focusing on both returning capital to shareholders and pursuing business development opportunities [45][46] Question: Insights on the enterprise-wide strategic review - Management indicated that significant cost savings are expected from the review, with more details to be provided in Q1 2026 [50][51] Question: Differentiation of presbyopia treatment - The company believes its presbyopia treatment offers a differentiated benefit-risk profile compared to existing modalities, focusing on safety and efficacy [79]