Viatris Advances Innovative Portfolio with Approval of Effexor® in Japan for Adults with Generalized Anxiety Disorder (GAD) Accessibility StatementSkip Navigation Addresses a Significant Unmet Need in Japan as First and Only Approved Treatment Option for GAD PITTSBURGH, March 23, 2026 /PRNewswire/ -- Viatris Inc.(Nasdaq: VTRS), a global healthcare company, today announced that Japan's Ministry of Health, Labour and Welfare (MHLW) has approved Effexor® SR 37.5 mg / 75 mg capsules (venlafaxine hydrochloride), ...

Core Insights - Viatris reported strong financial results for Q4 and full year 2025, with total revenues of $3.7 billion for Q4 and $14.3 billion for the full year, meeting or exceeding financial guidance across all key metrics [1][2][3] - The company completed an enterprise-wide strategic review, expecting to deliver $650 million in total cost savings while reinvesting up to $250 million over the next three years [1][3] - Viatris anticipates regulatory decisions for six product candidates in 2026 and multiple important pipeline milestones, positioning itself for sustainable growth [1][3] Financial Performance - Q4 2025 total revenues increased by 5% compared to Q4 2024, while full year revenues decreased by 3% compared to 2024 [2][3] - U.S. GAAP net loss for Q4 2025 was $340.1 million, a 34% improvement from a loss of $516.5 million in Q4 2024 [2][3] - Adjusted net earnings for Q4 2025 were $658.7 million, with adjusted EPS of $0.57, reflecting a 6% increase from Q4 2024 [2][3] Strategic Initiatives - The company initiated restructuring activities as part of its strategic review, expecting a global workforce reduction of up to 10% [3][6] - Total pre-tax charges related to restructuring are estimated between $700 million and $850 million, with anticipated savings of $600 million to $700 million once fully implemented [3][6] - Viatris plans to provide a balanced capital allocation approach for 2026, returning over $1 billion to shareholders in 2025 [1][3] Product Pipeline and Regulatory Updates - The company generated approximately $78 million in new product revenues in Q4 2025, with expectations of $450 million to $550 million in new product revenues for 2026 [2][3] - Viatris has several regulatory submissions under review, including a J-NDA for pitolisant in Japan and an NDA for a low-dose estrogen weekly patch in the U.S. [2][6] - The FDA has assigned a PDUFA goal date of July 30, 2026, for the low-dose estrogen patch and October 17, 2026, for MR-141 [6] Market Performance - Generics net sales were impacted by competition in North America and government price regulations in Japan, while brands net sales showed strength in Greater China and Emerging Markets [2][3] - The company expects continued operational growth driven by its base business and net cost savings in 2026 [1][3]

Core Viewpoint - Harmony Biosciences Holdings, Inc. reported strong preliminary, unaudited net product revenue for Q4 and full year 2025, indicating continued growth and profitability in the biotech sector [1] Financial Performance - The company announced Q4 2025 net product revenue of approximately $243 million [1] - Full year 2025 net product revenue reached approximately $868 million [1] - Harmony has achieved six consecutive years of revenue growth, demonstrating a solid financial trajectory [1] Business Strategy - Harmony is on track to extend the pitolisant franchise, which is a key component of its product portfolio [1] - The company is positioning itself as a profitable, self-funding biotech entity with a robust late-stage pipeline [1] - Strong long-term growth prospects are highlighted, reinforcing the company's strategic direction [1]

Core Insights - Viatris Inc. (NASDAQ:VTRS) is recognized as one of the top cheap stocks under $20, with recent regulatory milestones enhancing its investment appeal [1] Regulatory Milestones - The FDA approved Viatris' octreotide acetate for injectable suspension, a generic version of Sandostatin® LAR Depot, for treating acromegaly and certain types of diarrhea associated with tumors [1] - The FDA accepted the New Drug Application (NDA) for Viatris' investigational low dose estrogen weekly patch for contraception [2] - The FDA cleared the Investigational New Drug (IND) application for MR-146, a gene therapy candidate for neurotrophic keratopathy, with plans for a Phase 1/2 clinical trial starting in H1 2026 [2] - The Japan Pharmaceuticals and Medical Devices Agency (PMDA) accepted the Japanese New Drug Application (J-NDA) for pitolisant in obstructive sleep apnea syndrome, with plans to submit a J-NDA for narcolepsy by year-end [3] Company Overview - Viatris is a global healthcare company providing a wide range of pharmaceutical products across various therapeutic areas, including oncology, cardiovascular, dermatology, immunology, eye care, gastroenterology, and women's healthcare [4] - The company's operations are segmented into Developed Markets, Greater China, JANZ, and Emerging Markets [4]

Core Insights - Viatris Inc. (VTRS) has announced four significant regulatory achievements in its pipeline, highlighting its R&D progress for 2025 and its commitment to advancing its portfolio globally [2][9]. Regulatory Approvals - The FDA has approved Viatris' octreotide acetate for injectable suspension, a generic version of Sandostatin LAR Depot, which is used for treating acromegaly and certain types of diarrhea related to tumors [3][4]. - This approval marks VTRS' first injectable product utilizing microsphere technology and is the fourth injectable approval for the company in 2025, enhancing its generics portfolio with complex, high-value products [4]. - The FDA has accepted VTRS' new drug application (NDA) for a low-dose estrogen weekly contraceptive patch, aimed at women with a BMI below 30 kg/m², with a target action date set for July 30, 2026 [5][6]. - The patch delivers approximately 150 mcg of norelgestromin and 17.5 mcg of ethinyl estradiol daily, representing a new option for women seeking lower estrogen doses [6][7]. - The FDA has cleared an investigational new drug (IND) application for MR-146, a gene therapy candidate for neurotrophic keratopathy, with a phase I/II clinical trial planned for the first half of 2026 [8][9]. - Viatris has also received acceptance for its Japanese NDA for pitolisant in obstructive sleep apnea syndrome (OSAS), with plans to submit a separate NDA for narcolepsy by year-end [10][11]. Company Performance - Viatris has demonstrated strong performance over the past six months, with shares increasing by 34.6%, compared to the industry growth of 6.1% during the same period [12]. - The company's expansion in Emerging Markets and robust growth in Greater China are positively impacting sales, with new drug approvals expected to further enhance its portfolio [13].

Summary of Viatris Conference Call Company Overview - **Company**: Viatris (NasdaqGS: VTRS) - **Event**: UBS Healthcare Conference - **Date**: November 11, 2025 Key Updates and Financial Performance - Viatris reported a positive momentum in business with an expected operational revenue growth of **2-3%** for 2025, excluding Indor [4][80] - The company is on track to return over **$1 billion** to shareholders, including **$500 million** in share repurchases for the year [4][80] New Product Launches - Anticipated new product revenue is projected to be in the range of **$450 million to $550 million** annually, driven by existing products and upcoming launches [6][4] - Key products contributing to this revenue include: - **Iron sucrose** - **Glucagon** - **Paclitaxel** - Upcoming launches: **Liraglutide**, **Effexor GAD**, **Sotagliflozin** [6][4] Geographic Performance - **North America**: - Experienced competition in generic products, particularly **XULANE LO** [17][22] - Decline primarily attributed to the impact of Indor [19][22] - Strong double-digit growth noted in products like **Breyna** and **Uptravi** [22][22] - **Emerging Markets**: - Strong growth driven by established brand business, particularly in **Turkey**, **Mexico**, and **emerging Asia** [23][23] - Stabilization of lower-margin ARV products has supported growth in the generics business [23][23] - **Japan**: - Facing normal price regulations but focusing on adding innovative assets to stabilize and grow the business [26][26] - Recent acquisition of **Pitolisant** and **Spidea** expected to enhance the portfolio [26][26] - **China**: - Achieved **9% operational growth** driven by a diversified commercial model and strong brand demand [28][28] - Over **10,000 customers** across various channels, with expectations for low to mid-single-digit growth over time [31][31] Pipeline and Future Products - Excitement around **fast-acting meloxicam** as a non-opioid alternative for acute pain management, targeting a launch in the second half of **2026** [34][41] - Anticipated FDA filings for several products, including **Effexor GAD** and **Salatogrel**, with enrollment for Salatogrel on track to complete by the end of **2026** [51][52] Indor Remediation and Strategic Review - Progress on remediation efforts for Indor, with operational readiness for reinspection expected in **2026** [54][54] - An enterprise-wide strategic review initiated to ensure sustainable growth, with details expected in **Q1 2026** [60][60] Capital Allocation Strategy - Viatris maintains a balanced capital allocation strategy, focusing on business development and capital return, with a **50/25/25** framework [71][71] - The company is looking for opportunities to invest in durable, higher-margin innovative assets, particularly in the U.S. market [73][73] Conclusion - Viatris is optimistic about its position going into **2026**, with a focus on executing its strategic priorities, enhancing its product pipeline, and addressing challenges in various markets [80][80]

Core Insights - Viatris Inc. (VTRS) reported third-quarter 2025 adjusted earnings per share (EPS) of 67 cents, exceeding the Zacks Consensus Estimate of 63 cents, but down from 75 cents in the same quarter last year [1][7] - Total revenues for the quarter were $3.76 billion, a 2% decline year over year on an operational basis, yet surpassing the Zacks Consensus Estimate of $3.6 billion [1][7] Revenue Breakdown - Total sales reached $3.7 billion, down 2% year over year, with a 1% decline on a divestiture-adjusted operational basis [3] - Sales from Developed Markets were $2.25 billion, down 5% on a divestiture-adjusted operational basis, but slightly above the Zacks Consensus Estimate of $2.20 billion [3] - Emerging Markets generated $570.4 million in sales, reflecting a 7% increase on a divestiture-adjusted operational basis, beating the Zacks Consensus Estimate of $550 million [4] - Sales from Japan, Australia, and New Zealand (JANZ) totaled $306.3 million, down 9% on a divestiture-adjusted operational basis, yet exceeding the Zacks Consensus Estimate of $303 million [4] - Greater China sales amounted to $615.2 million, up 9% on a divestiture-adjusted operational basis, surpassing the Zacks Consensus Estimate of $579 million [4] Product Category Performance - Revenues from Brands increased by 3% to $2.4 billion, with a 1% rise on a divestiture-adjusted operational basis, driven by strong performance in Greater China and Emerging Markets [5] - Key branded products included Lipitor with sales of $396.1 million, Norvasc at $179.7 million, and EpiPen at $157.2 million, while Lyrica sales decreased to $126.5 million [8] Generics Performance - Generics revenue was $1.31 billion, down 5%, with a 6% decline on an operational change basis, primarily due to the impact from the Indore facility [9][10] - The decline in generics was offset by growth in complex products in North America and strong performance in key European markets [9] Financial Guidance and Shareholder Returns - Viatris raised its 2025 revenue guidance to a range of $13.9-$14.3 billion, up from the previous guidance of $13.5-$14 billion, and adjusted EPS guidance to $2.25-$2.35 from $2.16-$2.30 [12] - The company has returned over $920 million to shareholders year to date, including more than $500 million in share repurchases, and is on track to return over $1 billion in 2025 [11] Strategic Developments - Viatris acquired Aculys Pharma, gaining exclusive rights in Japan for pitolisant and plans to file two new drug applications in Japan [13] - The acquisition also includes rights for Spydia Nasal Spray, approved in Japan for treating status epilepticus [14]

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 [26][27] - Adjusted gross margin for the quarter was 56%, in line with expectations, but impacted by the Indore situation [28][29] - Free cash flow generated in the quarter was $658 million, with an adjusted figure of $728 million excluding transaction-related costs [29][30] 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 [26][27] - 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 [27][28] - Emerging markets experienced a 7% increase in net sales, driven by established brands in key markets such as Turkey and Mexico [27][28] 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 [27] - 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 [28] Company Strategy and Development Direction - The company is focusing on three key areas for sustained profitable growth: a global generics business evolving towards higher-margin complex products, an established brands business strengthened by adding brands, and an innovative brands business expanding through late-stage or in-market growth assets [6][7] - 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 [6][7] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the fundamentals of the business, anticipating momentum to carry into 2026. They highlighted strong commercial execution and pipeline advancement as key drivers [5][11] - The company plans to provide a detailed outlook for 2026 in the first quarter of next year, considering factors such as timing of approvals and competitive dynamics [31][32] 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][30] - The acquisition of Aculys Pharma in Japan adds innovative CNS assets to the portfolio, strengthening the company's presence in a strategically important market [10][11] Q&A Session Questions and Answers Question: Update on the Indore resolution situation - Management reported significant progress in remediation efforts at the Indore facility and a productive meeting with the FDA regarding reinspection timing, which remains at the agency's discretion [36][37] Question: Performance of EpiPen and Lipitor - The strength of the Lipitor brand outside the U.S., particularly in China, has driven performance. EpiPen has seen stable market share, with strong growth in Europe following a relaunch in Canada [38][39] Question: Feedback from the FDA on fast-acting meloxicam - The company is optimistic about obtaining opioid-sparing language in the product label, with a pre-NDA meeting scheduled with the FDA to discuss this [44][45] 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 [46][47] Question: Insights on the enterprise-wide strategic review - Management indicated that significant cost savings are expected from the review, with a focus on various operational areas. Specific details will be provided in Q1 [51][52]

Core Insights - Viatris Inc. reported strong third-quarter 2025 financial results, reflecting solid operational execution and strategic focus on growth initiatives [2][6][14] - The company updated its full-year financial guidance, raising and narrowing ranges for total revenues, adjusted EBITDA, and adjusted EPS, primarily due to foreign exchange impacts and share repurchases [2][18][19] Financial Performance - Total revenues for Q3 2025 were $3.76 billion, flat year-over-year, with a slight operational decline of 1% after adjusting for divestitures [4][14] - Net sales in developed markets decreased by 2%, while emerging markets saw a 7% increase, driven by strong performance in Greater China [4][14] - U.S. GAAP net loss for Q3 2025 was $(128.2) million, compared to net earnings of $94.8 million in Q3 2024, with diluted EPS at $(0.11) [4][14][37] Capital Allocation - The company returned over $920 million to shareholders year-to-date, including $500 million in share repurchases, and remains on track to exceed $1 billion in total capital returns in 2025 [2][12][14] - Free cash flow for Q3 2025 was $658 million, impacted by $70 million in transaction-related costs [5][14] Strategic Initiatives - Viatris is advancing its pipeline with key regulatory submissions, including a New Drug Application for a low-dose estrogen weekly patch and the acquisition of Aculys Pharma, enhancing its portfolio in Japan [2][14][11] - The company is conducting an enterprise-wide strategic review to identify operational efficiencies and reinvest savings into growth opportunities [14][16][17] Market Outlook - The company anticipates continued growth in emerging markets and specific developed markets, with a focus on launching new products and enhancing its operational capabilities [2][14][33] - Viatris plans to hold an Investor Event in Q1 2026 to provide updates on its strategic and financial outlook, including pipeline developments [17]

Core Insights - Viatris Inc. is a global healthcare company with a market cap of $12 billion, focusing on affordable medicines across various therapeutic areas [1] - The company's stock has significantly underperformed the broader market, declining 9.4% over the past year compared to a 19.6% gain in the S&P 500 Index [2] - Viatris announced the acquisition of Aculys Pharma, which will enhance its CNS portfolio with two neurological treatments, targeting regulatory approval in Japan by late 2025 [4] Financial Performance - Analysts expect Viatris' EPS to decline by 12.8% to $2.31 for the current fiscal year ending in December [5] - The company's earnings surprise history is mixed, with three beats and one miss in the last four quarters [5] Analyst Ratings - The consensus rating for Viatris stock is a "Hold," based on two "Strong Buy" ratings, six "Holds," and one "Moderate Sell" [5] - Truist Financial initiated coverage with a "Buy" rating and a $15 price target, citing confidence in the company's strategic shift and promising pipeline [7]