Amneal Pharmaceuticals (NasdaqGS:AMRX) Q4 2025 Earnings call February 27, 2026 08:30 AM ET Company ParticipantsAnastasios Konidaris - EVP and CFOAnthony DiMeo - Head of Investor RelationsChintu Patel - Co-Founder and Co-CEOChirag Patel - Co-Founder and Co-CEOChris Schott - Managing DirectorJoe Renda - SVP and Chief Commercial OfficerConference Call ParticipantsDavid Amsellem - Managing Director and Senior Research AnalystLes Sulewski - AnalystMatt Dellatorre - VP and Equity AnalystOperatorThank you all for ...

Unlocking Biosimilar Potential Ophthalmology Case Study FEBRUARY 2026 Introduction Ensuring that challenges to biosimilar uptake are continuously assessed and addressed is a critical part of unlocking their benefits. Biosimilar use is growing across therapy areas with different specialties gaining experience and confidence. These biosimilars have also provided substantial savings for the overall health system. Between 2023 and 2025, IQVIA Institute has published two reports highlighting the importance of ph ...

Core Insights - Organon reported $6.2 billion in revenue and $1.9 billion in adjusted EBITDA for 2025, with a 3% decline in revenue on both reported and ex-FX basis, although the biosimilar franchise performed better than expected, particularly driven by HADLIMA [2][3][4] Revenue and Financial Performance - The company guided for approximately $6.2 billion in revenue and $1.9 billion in adjusted EBITDA for 2026, indicating a stable outlook compared to 2025 [3][20] - Adjusted gross margin is expected to decline by about 75–100 basis points in 2026, primarily due to higher cost of goods sold [21] - Organon reported a Q4 2025 net loss of $205 million, influenced by a $301 million goodwill impairment, while non-GAAP adjusted net income was $165 million for Q4 and $954 million for the full year [16][17] Biosimilars and Product Performance - The biosimilars segment, particularly HADLIMA, grew approximately 61% ex-FX in 2025, with expectations for flat to modest growth in 2026 [4][11][12] - The company launched a denosumab biosimilar in the U.S. in late September 2025, contributing to the biosimilars growth [11] - Nexplanon received FDA approval to extend its duration from three to five years, but management anticipates a volume headwind due to policy-driven access changes and a shift in reinsertions [5][9][10] Strategic Focus and Outlook - Organon aims to stabilize revenue, maintain profitability, and continue deleveraging, with a target of net leverage below 4.0x by the end of 2026 [3][18] - The company plans to reduce its dividend payout ratio to support debt reduction and has divested the JADA System, generating approximately $390 million in net proceeds [18][20] - Management expects interest expense of about $500 million and depreciation of about $140 million for 2026, with a non-GAAP tax rate projected between 27.5% and 29.5% [22]

Core Insights - Regeneron Pharmaceuticals (REGN) reported a solid performance for Q4 2025 and full-year 2025, with overall revenues increasing despite a significant decline in sales of its flagship product, Eylea [1] Eylea Performance - Eylea sales in the U.S. fell by 42% to $2.7 billion in 2025, driven by competitive pressures, market share loss to compounded bevacizumab, and patient transitions to Eylea HD [2] - Eylea remains Regeneron's largest revenue contributor, but declining sales are impacting overall revenues [3] - Eylea HD, a higher-dose formulation, saw sales increase by 36% to $1.6 billion in the U.S. in 2025, as Regeneron aims to defend its market share [5][10] Competitive Landscape - Roche's Vabysmo has intensified competition, achieving sales growth of 12% to CHF 4.1 billion in 2025 [4] - Regeneron introduced Eylea HD to improve durability and extend dosing intervals in response to competitive pressures [4] Future Projections - Eylea sales are expected to decline further in 2026, particularly in the second half of the year as multiple biosimilars enter the U.S. market [5][10] - Eylea HD is gaining traction due to steady label expansions, with recent FDA approvals enhancing its market position [6][7] Other Revenue Streams - Regeneron's revenue is bolstered by its share of profits from global Dupixent sales, which continue to grow due to strong demand across various indications [8] - Libtayo, Regeneron's PD-1 inhibitor, generated $1.4 billion in sales in 2025, reflecting a 19% year-over-year increase [11] Oncology Developments - The oncology portfolio received a boost with the FDA's accelerated approval of linvoseltamab-gcpt for relapsed or refractory multiple myeloma [12] - The European Commission approved Ordspono for relapsed or refractory follicular lymphoma or diffuse large B-cell lymphoma, further strengthening Regeneron's oncology franchise [13] Pipeline and Future Approvals - Regeneron has a robust pipeline, with additional drug approvals expected to support revenue growth [13] - The company submitted a biologics license application for DB-OTO, a gene therapy for profound genetic hearing loss, with a decision expected in H1 2026 [14] - Regeneron is also pursuing approval for garetosmab for fibrodysplasia ossificans progressiva and expanding its obesity-focused pipeline [15]

Financial Data and Key Metrics Changes - In 2025, Organon reported $6.2 billion in revenue and $1.9 billion of adjusted EBITDA, representing a 3% decline on both a reported and ex-FX basis [6] - Adjusted gross margin for Q4 2025 was 56.7%, down from 60.6% in Q4 2024, primarily due to pricing pressure and unfavorable product mix [22] - Net loss for Q4 2025 was $205 million, or $0.79 per diluted share, compared to net income of $109 million, or $0.42 per diluted share in Q4 2024 [23] Business Line Data and Key Metrics Changes - Women's health revenue decreased 16% ex-FX in Q4 and 2% for the year, with Nexplanon sales down 20% ex-FX in Q4 and 4% for the full year [11] - The fertility business declined 6% ex-FX in Q4 2025 but grew 8% ex-FX for the full year, driven by performance in the U.S. [14] - Biosimilars revenue was driven by HADLIMA, which grew 61% ex-FX globally for the full year [16] Market Data and Key Metrics Changes - Nexplanon faced challenges due to government policy-related access restrictions impacting its market share in the U.S. [12] - The JADA System generated $74 million in revenue in 2025 before its divestiture, which will impact consolidated revenue in 2026 [15] - The company expects strong growth in Latin America for Nexplanon, offsetting U.S. declines [14] Company Strategy and Development Direction - Organon decided to lower its dividend payout ratio to focus on debt reduction and improve its balance sheet capacity for future growth opportunities [7] - The company is scrutinizing spending and has discontinued early-stage clinical programs to focus on products already in the market [9] - For 2026, Organon expects to maintain revenue and adjusted EBITDA in line with 2025, targeting approximately $6.2 billion in revenue and $1.9 billion in adjusted EBITDA [9] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving 2026 targets despite anticipated gross margin deterioration and ongoing operational challenges [10] - The company is committed to managing operating expenses and capital deployment to support deleveraging efforts [32] - Management highlighted the importance of maintaining performance aligned with the previous year while navigating a competitive landscape [32] Other Important Information - The company divested the JADA System, resulting in approximately $390 million in net proceeds to reduce net debt in 2026 [8] - Organon expects to achieve net leverage below 4x by the end of 2026, supported by debt repayments and revenue from the JADA divestiture [27] Q&A Session Summary Question: Concerns about channel behavior issues and audit committee investigation scope - Management could not provide additional details regarding the audit committee's findings beyond what was previously disclosed [36] Question: Status of FDA draft guidance on biosimilars and its impact - Management views the FDA guidance as incremental and believes their current biosimilar strategy is appropriate for future growth [40] Question: Nexplanon contribution to 2026 sales guidance - Nexplanon is expected to be roughly flat year-on-year, with growth anticipated outside the U.S. but a dip in the U.S. due to the transition to a five-year label [41] Question: Operating costs and margins outlook - Management emphasized the need to streamline operations while ensuring that cost reductions do not hinder revenue growth opportunities [51] Question: Pressure on established brands and competitive dynamics for Vtama - Management expects established brands to stabilize but acknowledges potential challenges, particularly in the respiratory segment [58]

Financial Data and Key Metrics Changes - In 2025, Organon reported $6.2 billion in revenue, a decrease of 3% on both a reported and ex-FX basis [5] - Adjusted EBITDA for 2025 was $1.9 billion, with adjusted EBITDA margins remaining flat compared to 2024 despite a 150 basis points decline in gross margin [8][10] - The net loss for Q4 2025 was $205 million, or $0.79 per diluted share, compared to a net income of $109 million, or $0.42 per diluted share in Q4 2024 [23][24] Business Line Data and Key Metrics Changes - Women's health revenue decreased by 16% ex-FX in Q4 and 2% for the full year, with Nexplanon sales down 20% ex-FX in Q4 and 4% for the year [11] - The fertility business declined 6% ex-FX in Q4 but grew 8% for the full year, driven by performance in the U.S. [13] - Biosimilars revenue was driven by Hadlima, which grew 61% ex-FX globally for the full year [15] Market Data and Key Metrics Changes - The U.S. market faced headwinds due to government policy-related access restrictions impacting Nexplanon sales [12] - Internationally, particularly in Latin America, there was improved access contributing to growth in Nexplanon [43] - The divestiture of the JADA System resulted in approximately $390 million in net proceeds, impacting consolidated revenue in 2026 [8][9] Company Strategy and Development Direction - The company decided to lower its dividend payout ratio to focus on debt reduction and improve its balance sheet capacity for future growth opportunities [7] - Organon is committed to managing operating expenses and capital deployment in a disciplined manner to achieve progress on deleveraging efforts [33] - The company expects to maintain revenue and adjusted EBITDA in 2026 at levels similar to 2025, with a focus on cost savings and operational efficiency [9][10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in delivering results in 2026, despite anticipated challenges in gross margin and operating expenses [10] - The company expects a flat revenue outlook for Nexplanon in 2026, with growth anticipated in international markets [42][43] - Management acknowledged the competitive environment in the U.S. for the fertility business and the potential headwinds from the transition to a five-year label for Nexplanon [13][54] Other Important Information - Organon achieved over $200 million in cost savings in 2025, which helped offset investments in growth drivers [8] - The company expects adjusted gross margin in 2026 to decline by 75-100 basis points compared to the prior year [29] - Free cash flow for 2025 was $960 million, consistent with the prior year, with expectations for similar performance in 2026 [25] Q&A Session Summary Question: Concerns about channel behavior issues and audit committee scope - Management could not provide additional details regarding the audit committee's findings [37] Question: Status of biosimilar policy and its impact on Organon's business - Management views the FDA's draft guidance as an incremental change and remains optimistic about growth opportunities in biosimilars [41] Question: Nexplanon's contribution to 2026 sales guidance - Nexplanon is expected to be roughly flat year-on-year, with growth anticipated in international markets [42][43] Question: Operating expense savings and underlying EBITDA performance - Management confirmed that some of the $275 million in savings would be redirected to revenue growth opportunities [47] Question: Update on the search for a permanent CEO - No public update was available regarding the CEO search [64] Question: Strategy for the Denosumab biosimilar - Management indicated that the peak revenues for the Denosumab product could reach around $100 million over five years [65]

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].