These gains partially offset headwinds, including the continued impact of the loss of exclusivity (LOE) for Atozet and challenges that emerged during the year. Morrissey highlighted policy-related changes in the U.S. affecting Nexplanon access and a revision to medical guidelines in certain international markets that deprioritized montelukast, impacting SINGULAIR.Biosimilars , driven primarily by HADLIMA and additional contributions from a denosumab biosimilar launch and TOFIDENCE, which Organon acquired in ...

Key Takeaways Regeneron expects Eylea sales to decline further in 2026 as biosimilars enter the U.S. market.Eylea HD sales rose 36% in 2025, supported by new FDA approvals and expanded dosing options.Growth in Dupixent and Libtayo, coupled with new oncology approvals, seeks to stabilize REGN's revenue base. Regeneron Pharmaceuticals (REGN) put up a decent performance for the fourth quarter of 2025 and full-year 2025 (reported last month) with overall revenues rising despite a continued decline in sales of i ...

Organon (NYSE:OGN) Q4 2025 Earnings call February 12, 2026 08:30 AM ET Company ParticipantsCarrie Cox - Board ChairJennifer Halchak - VP of Investor RelationsJoe Morrissey - Interim CEOJuan Camilo Arjona Ferreira - Head of R&DMatt Walsh - CFOMike Nedelcovych - Director of Equity ResearchPavan Patel - Associate, Biotechnology and Pharmaceuticals Equity ResearchUmer Raffat - Senior Managing DirectorConference Call ParticipantsEthan Brown - Equity Research AnalystTerence Flynn - Equity Research AnalystNone - A ...

Organon (NYSE:OGN) Q4 2025 Earnings call February 12, 2026 08:30 AM ET Speaker7Hello, and welcome to the Organon fourth quarter and full year 2025 earnings call and webcast. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session, and if you would like to ask a question during this time, please press star one on your telephone keypad. I would now like to turn the conference over to Jennifer Halchak, Vice President, Investor ...

Core Viewpoint - CVS Health is enhancing access to lower-cost biosimilar medications, specifically osteoporosis treatments, by introducing new options in its formulary, which will be effective from April 1, 2026, providing significant cost savings compared to original brands [1]. Group 1: Introduction of Biosimilars - CVS Caremark will add osteoporosis biosimilars Ospomyv and Stoboclo, along with generic teriparatide options Bonsity and Tymlos, to its major national commercial template formularies [1]. - These biosimilars will replace Prolia and Forteo, offering customers more affordable alternatives with strong clinical and supply confidence [1]. Group 2: Cost Savings and Strategy - The preferred biosimilar approach is over 50% lower in costs per prescription compared to the original brand [1]. - CVS Caremark's biosimilar formulary strategy has already helped customers realize $1.5 billion in gross savings [5]. - The company has successfully transitioned 96% of its client members using Humira to a biosimilar, demonstrating its commitment to driving competition and cost savings [5]. Group 3: Specialty Drug Management - CVS Specialty proactively informs prescribers and patients about formulary changes, ensuring a smooth transition to covered alternatives [6]. - Advanced technology capabilities streamline the prescription process for doctors, allowing for quick approvals and enhancing patient communication [7]. Group 4: Importance of Biosimilars - Biosimilars are crucial for treating complex chronic conditions and are often injectable medications that require careful handling [8]. - The introduction of Ospomyv and Stoboclo is significant for treating osteoporosis, which is vital for preventing fractures and maintaining independence in older adults [9][10]. Group 5: Company Overview - CVS Health operates approximately 9,000 retail pharmacy locations and serves around 87 million plan members through its pharmacy benefits manager [11]. - The company aims to connect consumers to better health through personalized, technology-driven services, ultimately lowering overall healthcare costs [11].

Core Insights - Alvotech has entered into supply and commercialization agreements with Sandoz for multiple biosimilar candidates in Canada, Australia, and New Zealand, enhancing its global market strategy ahead of regulatory approvals [1][2] Group 1: Agreements and Responsibilities - The agreement in Canada includes one biosimilar candidate in ophthalmology, supplied as a prefilled syringe for intravitreal injection [2] - In Australia and New Zealand, the agreement covers three biosimilar candidates across immunology and gastroenterology in various formulations [2] - Sandoz will handle regulatory submissions, commercialization, and distribution, while Alvotech will manage development, global clinical activities, and manufacturing, supplying finished products to Sandoz under exclusive arrangements [3] Group 2: Strategic Goals and Market Presence - The collaboration aims to enhance patient access to biologic medicines in Canada, Australia, and New Zealand, with Sandoz committed to providing sustainable and affordable solutions [4] - Alvotech's strategy focuses on securing commercial pathways for its biosimilars portfolio globally, leveraging its integrated development and manufacturing platform [2][4] - Alvotech has five biosimilars already approved and marketed in various global markets, with a pipeline of nine disclosed biosimilar candidates targeting multiple therapeutic areas [5]

Core Insights - Alvotech has entered into supply and commercialization agreements with Sandoz for multiple biosimilar candidates in Canada, Australia, and New Zealand, enhancing its strategy for global market access ahead of regulatory approvals [1][2] Group 1: Agreements and Responsibilities - The agreement in Canada includes one biosimilar candidate in ophthalmology, while the agreements in Australia and New Zealand cover three biosimilar candidates in immunology and gastroenterology [2] - Sandoz will handle regulatory submissions, commercialization, and distribution in the respective regions, while Alvotech will manage development, global clinical activities, and manufacturing [3] Group 2: Strategic Goals and Market Presence - The collaboration aims to improve patient access to biologic medicines in Canada, Australia, and New Zealand, with Sandoz committed to making these medicines affordable and sustainable [4] - Alvotech has a pipeline of nine disclosed biosimilar candidates targeting various conditions, including autoimmune disorders and cancer, and has already marketed five biosimilars globally [5]

Core Viewpoint - Samsung Epis Holdings reported strong year-to-date sales growth driven by its biosimilars portfolio following its spin-off, with a focus on sustainable growth and long-term value creation for shareholders [1][3]. Financial Performance - In Q4 2025, Samsung Bioepis achieved consolidated revenue of KRW 429.4 billion, with an operating profit of KRW 29.2 billion, marking a year-over-year increase of 23% in revenue and 14% in operating profit [2]. - For the full year 2025, revenue reached KRW 1.672 trillion (+9%), while operating profit was KRW 375.9 billion (-14%). Excluding milestone revenue, sales revenue increased by 28% to KRW 1.626 trillion, and operating profit surged by 101% to KRW 330.8 billion [3]. Product Development and Launches - Samsung Bioepis launched EPYSQLI (SB12), a biosimilar to Soliris, in the US in April 2025, enhancing access for patients with rare diseases [4]. - OBODENCE (SB16) and XBRYK (SB16), biosimilars to Prolia, received FDA and EC approval in February 2025, with launches in Europe occurring in December 2025 and January 2026, respectively [4]. - As of January 2026, Samsung Bioepis will directly commercialize four products in Europe, including EPYSQLI, OBODENCE, XBRYK, and BYOOVIZ [5]. Future Outlook - Samsung Epis Holdings aims to increase global biosimilar sales by over 10% year-over-year and plans to expand its portfolio to 20 biosimilars by 2030 [6]. - The company is also developing novel therapeutics, with plans to initiate clinical studies for SBE303, its first antibody-drug conjugate targeting Nectin-4, in patients with advanced solid tumors [6]. Subsidiary Developments - Epis NexLab, a new subsidiary under Samsung Epis Holdings, is focused on developing a peptide-based drug delivery platform [7].

Industry Overview - The Zacks Medical - Dental Supplies industry is expected to maintain upward momentum in 2026 due to innovation, an aging population, and normalized orders post-COVID-19 [1] - The global medical supplies industry is projected to reach $163.5 billion by 2027, growing at a CAGR of 3.4% from 2022 to 2027 [4] Technological Advancements - Continued adoption of digital services and AI-enabled tools is anticipated to enhance patient experience and reduce administrative burdens for physicians [2] - Innovations such as CAD/CAM systems, 3D imaging, and AI diagnostics are expected to improve treatment efficacy and broaden product use [8] Market Trends - The industry is shifting towards higher-margin specialty areas like oncology and urology, with precision health and theranostics emerging as significant trends [3] - There is a growing emphasis on preventive care and minimally invasive procedures, which is expanding market segments for dental consumables [9] Regional Growth Drivers - Emerging markets, particularly in Asia-Pacific, are benefiting from increased healthcare expenditure and improved access to care, contributing to faster growth rates [10] Economic Factors - Strong healthcare infrastructure and higher disposable income in developed regions support the adoption of advanced dental products [11] Challenges - U.S. tariffs have raised costs on essential imported dental supplies, leading to increased prices and supply-chain disruptions [12] - The industry is responding by shifting supply chains towards domestic production to mitigate tariff exposure [13] Company Performance - The industry has outperformed its sector with a collective gain of 6.6% over the past year, compared to the Zacks Medical sector's rise of 1.9% [16] - The industry is currently trading at a forward P/E of 17.67X, lower than the S&P 500's 22.81X [19] Company Insights - West Pharmaceutical is expected to maintain growth momentum in 2026, driven by demand for high-value products and operational improvements [21][22] - McKesson anticipates revenue growth of 11-15% in fiscal 2026, supported by strong demand in specialty distribution [30] - Cardinal Health expects revenues from its Pharmaceutical segment to grow 15-17% year-over-year, with challenges from competitive pricing pressures [35] - Align Technology is positioned for growth in 2026 due to restructuring actions and technological innovations, with a projected revenue increase of 3.7% [42]

Financial Performance - The company reported a consolidated revenue of INR 8,727 crores ($971 million), reflecting a year-over-year growth of 4.4% and a sequential decline of 0.9% [7] - The EBITDA margin was reported at 23.5%, which included a one-time provision related to new labor codes; adjusting for this, the underlying EBITDA margin was 24.8% [10][15] - Profit after tax attributable to equity holders was INR 1,210 crores ($135 million), a decline of 14% year-over-year and 16% sequentially [11] Business Line Performance - The North America generic business generated revenues of $338 million, a decline of 16% year-over-year and 9% sequentially, primarily due to lower lenalidomide sales [21] - The European generic business reported revenue of $140 million, showing a growth of 4% year-over-year and sequentially [21] - The emerging market business delivered revenue of INR 1,896 crores, reflecting robust growth of 32% year-over-year and 15% sequentially [22] - The India business reported revenue of INR 1,603 crores, achieving a healthy double-digit growth of 19% year-over-year and 2% sequentially [23] - The PSA business reported revenue of $92 million, resulting in a decline of 5% year-over-year and 15% sequentially [24] Market Performance - The company’s emerging market growth was driven by new product launches and favorable forex, with Russia showing a growth of 21% year-over-year [22] - In India, the company outperformed the Indian pharmaceutical market with a quarterly growth of 12.3% compared to the market's 11.8% [23] Strategic Direction - The company entered a strategic collaboration with Immutep for the commercialization of a novel immunotherapy oncology drug, Eftilagimod Alpha, with potential milestones of up to $350 million [16] - The integration of the acquired nicotine replacement therapy business is progressing well, with 85% of the business now under operational controls [16] - The company is focused on advancing its key pipeline products, including Semaglutide and Abatacept, and aims to enhance its innovation portfolio through strategic collaborations [24] Management Commentary - Management expressed confidence in the sustainability of the strong growth in the India business, attributing it to the performance of innovative products and effective brand strategies [32][45] - The management acknowledged challenges in the U.S. market due to lenalidomide sales decline but noted that the base business is growing [56] - The company is preparing for potential competition in the Semaglutide market but remains optimistic about maintaining a competitive edge [49][51] Other Important Information - The company announced a science-based net-zero climate target, making it the only Indian pharmaceutical company to commit to such a target by FY24 [20] - The company has a net cash surplus of INR 3,069 crores ($342 million) as of December 31, 2025 [12] Q&A Session Question: What is the organic growth for the India business considering the Stugeron acquisition? - Management indicated that organic growth without acquisitions is more than 17% [29][30] Question: What is driving the strong growth in the India business? - The growth is primarily driven by innovative products that are gaining market recognition [32] Question: What are the expectations for Semaglutide approval in Canada? - Approval is expected between February and May, with preparations for a launch in Q4 or Q1 [40][41] Question: How much has lenalidomide contributed to EBITDA margins this quarter? - Management could not disclose specific figures due to confidentiality but noted that the decline in the U.S. is primarily due to lenalidomide [56] Question: What are the timelines for Denosumab and Rituximab in the U.S.? - Denosumab is expected to face delays of at least six months, while Rituximab's re-inspection is anticipated soon [60][66] Question: What is the addressable market for Abatacept in Europe? - The addressable market is estimated to be around $2 billion, with plans to launch in multiple countries [94]