Core Viewpoint - Alvotech has filed its Annual Report 2025 with the U.S. Securities and Exchange Commission, highlighting its commitment to transparency and regulatory compliance [1]. Company Overview - Alvotech is a biotechnology company focused on developing and manufacturing biosimilar medicines globally [2]. - The company aims to be a leader in the biosimilars market by providing high-quality, cost-effective products through a fully integrated approach and extensive in-house capabilities [2]. - Alvotech has five biosimilars approved and marketed in various global markets, including those for Humira®, Stelara®, Simponi®, Eylea®, and Prolia®/Xgeva® [2]. - The current development pipeline includes nine disclosed biosimilar candidates targeting autoimmune disorders, eye disorders, osteoporosis, respiratory diseases, and cancer [2]. - Alvotech has established strategic commercial partnerships to enhance its global reach and leverage local expertise across markets such as the United States, Europe, Japan, China, and parts of South America, Africa, and the Middle East [2].

Core Viewpoint - Alvotech has filed its Annual Report 2025 with the SEC, highlighting its commitment to transparency and regulatory compliance [1]. Company Overview - Alvotech is a biotechnology company focused on developing and manufacturing biosimilar medicines globally [2]. - The company aims to be a leader in the biosimilars market by providing high-quality, cost-effective products through a fully integrated approach [2]. - Alvotech has five biosimilars approved and marketed in various global markets, including those for Humira, Stelara, Simponi, Eylea, and Prolia/Xgeva [2]. - The current development pipeline includes nine disclosed biosimilar candidates targeting autoimmune disorders, eye disorders, osteoporosis, respiratory diseases, and cancer [2]. - Alvotech has established strategic commercial partnerships to enhance its global reach and leverage local expertise across multiple regions, including the U.S., Europe, Japan, China, and parts of South America, Africa, and the Middle East [2].

Core Viewpoint - Alvotech has published its Annual Report for 2025, highlighting its focus on the development and manufacture of biosimilar medicines, with a commitment to becoming a global leader in this sector [1]. Company Overview - Alvotech is a biotechnology company founded by Robert Wessman, dedicated to developing and manufacturing biosimilar medicines for patients worldwide [2]. - The company aims to deliver high-quality, cost-effective products and services through a fully integrated approach and broad in-house capabilities [2]. - Alvotech has five biosimilars approved and marketed in multiple global markets, including biosimilars to Humira® (adalimumab), Stelara® (ustekinumab), Simponi® (golimumab), Eylea® (aflibercept), and Prolia®/Xgeva® (denosumab) [2]. - The current development pipeline includes nine disclosed biosimilar candidates targeting autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer [2]. - Alvotech has established a network of strategic commercial partnerships to enhance its global reach and leverage local expertise in various markets, including the United States, Europe, Japan, China, and parts of South America, Africa, and the Middle East [2].

Financial Performance - The company reported a net loss of $551.7 million for the year ended December 31, 2023, and an accumulated deficit of $2,409.8 million as of December 31, 2025[31]. - Cash and cash equivalents stood at $172.4 million as of December 31, 2025, indicating a level of financial stability despite uncertainties[48]. - The company has incurred significant losses since inception and may continue to do so, with expectations of ongoing research and development expenses increasing substantially[30]. - As of December 31, 2025, the company had $1,299.1 million in outstanding indebtedness, including $1,031.6 million under the Secured Loan Facility and $96.7 million under the Senior Term Loan Facility[55]. - The company’s ability to generate sufficient cash flow to meet its debt obligations is uncertain, which may require asset sales or additional financing[54]. - The company may need to raise additional funding, which could dilute existing shareholders and restrict operations[47]. Regulatory Approvals and Risks - The company has received marketing authorization for biosimilars AVT02 and AVT04 in over 30 countries, and for AVT03, AVT05, and AVT06 in Japan, the UK, and EEA as of December 31, 2025[40]. - The company received Complete Response Letters from the FDA regarding its BLAs for AVT03, AVT05, and AVT06, which could materially affect its business if resubmissions are not approved[30]. - The company plans to resolve deficiencies identified by the FDA related to its Reykjavik manufacturing facility to proceed with the commercialization of its biosimilars[67]. - The company faces significant regulatory risks, including evolving expectations and potential delays in obtaining necessary approvals[72]. - Regulatory approvals in the U.S., EU, UK, and Japan are critical for commercialization; any delays could adversely affect revenue generation[77]. - The FDA issued Complete Response Letters (CRLs) for AVT03, AVT05, and AVT06 in Q4 2025, citing manufacturing deficiencies that must be resolved[74]. Commercialization and Market Challenges - The company generated product revenue through sales of AVT02 and AVT04 in select markets, and also from newly approved biosimilars AVT03, AVT05, and AVT06[63]. - The company’s ability to generate revenue and achieve sustainable profitability depends on the successful commercialization of its approved biosimilars and the completion of research and development for other candidates[37]. - The commercial success of the company's products will depend on market acceptance by physicians, patients, and third-party payors, which is uncertain[157]. - The availability and adequacy of third-party coverage and reimbursement are critical for the commercialization of the company's biosimilar products[159]. - The company anticipates competition from multiple established players in the biosimilar market, including Amgen, Celltrion, and Sandoz, among others[148]. - The company may face challenges in obtaining regulatory approvals and achieving market penetration due to the competitive landscape[149]. Intellectual Property and Legal Risks - The company is subject to extensive patent clearances and potential litigation, which may delay the commercial launch of biosimilar products[105]. - The risk of patent infringement claims could lead to substantial costs and delays in the development and commercialization of product candidates[173]. - Legal proceedings related to patent litigation and intellectual property disputes may incur substantial costs and distract management, adversely affecting business operations[186]. - The company may face claims regarding the wrongful use of confidential information, which could lead to costly litigation and loss of intellectual property rights[191]. - The transition to a "first-inventor-to-file" system in the U.S. increases the risk of competitors obtaining patents for similar inventions, potentially threatening the company's market position[197]. - The complexity and costs associated with obtaining and enforcing biopharmaceutical patents are high, leading to uncertainty in the process[205]. Operational and Supply Chain Risks - The company relies on third parties for conducting clinical studies, and any failure on their part could hinder regulatory approval and commercialization efforts[33]. - The company relies on third-party manufacturers for clinical and commercial supplies, which poses risks related to quality and compliance with Good Manufacturing Practices (cGMP)[112]. - Delays in shipment or damage during transport could significantly impact project timelines and sales[116]. - The company engages single-source suppliers for critical services, and loss of these suppliers could materially impact business operations[131]. - The company must navigate complex regulatory environments across jurisdictions, which may increase operational complexity and costs[77]. - The company relies on third-party CROs for nonclinical and clinical studies, which poses risks if these parties fail to meet contractual duties or regulatory requirements[119]. Competitive Landscape - The company faces significant competition in the biosimilar market, particularly for products like Humira and Stelara, which could limit market penetration and revenue[141]. - Competitors may develop improved versions of reference products, which could significantly reduce the market potential for the company's biosimilar candidates[144]. - The company may encounter price competition from other biosimilars for the same reference products, which could adversely affect market share and revenue[170]. - The company anticipates pricing pressures due to managed healthcare trends and the influence of health maintenance organizations[163]. - Legislative initiatives in the U.S. may impact the ability of commercial partners to successfully commercialize products, potentially reducing the addressable market[165]. - The potential for legislative and regulatory actions by reference product manufacturers could delay or limit the approval of the company's biosimilars[146].

Core Viewpoint - Alvotech is focused on addressing FDA feedback and plans to resubmit its biologics license applications in the second quarter of 2026, aiming for FDA decisions by year-end 2026 [1][2]. Regulatory and Compliance - Alvotech has four active U.S. biologics license applications for biosimilars, which received complete response letters due to issues identified in a July 2025 FDA inspection [2]. - The Reykjavik facility remains FDA-approved, and Alvotech continues to manufacture on-market products while preparing a comprehensive response to avoid further inspections [5]. Commercial Execution and Product Launches - The company launched its second U.S. biosimilar, Selarsdi, in partnership with Teva, and has seen significant market share growth for its products [7]. - Alvotech's biosimilar to Humira (AVT-02/SIMLANDI) captured approximately 9% of the U.S. market, with the originator's share declining from 70% to 45% [7]. - The company has signed partnership agreements with Advanz Pharma and Dr. Reddy's, expanding its commercial footprint [7]. Pipeline Development - Alvotech has 30 biosimilars in development, representing over $185 billion in global sales potential, with a new program initiated approximately every two months [9]. - The company anticipates being among the first to launch a biosimilar to Entyvio, with regulatory submissions planned for later in 2026 [10]. Financial Performance - In Q4 2025, Alvotech reported total revenue of $173 million, a 13% increase year-over-year, with licensing revenues making up 75% of the total [12]. - For the full year 2025, total revenue reached $593 million, up 21%, with a gross margin of 61% and adjusted EBITDA of $137 million [13]. - The company ended 2025 with $172 million in cash, supported by financing activities, and expects to improve its leverage ratio in 2026 [14]. 2026 Outlook - Alvotech has reaffirmed its 2026 revenue guidance of $650 million to $700 million, with adjusted EBITDA expected to be between $180 million and $220 million [15]. - The company is targeting growth in supply revenues and anticipates quarterly fluctuations due to milestone timing and shipment patterns [15].

Financial Data and Key Metrics Changes - Total revenues for 2025 increased by 21% year-on-year to $593 million, with adjusted EBITDA rising by 27% to $137 million, representing a margin of 23% [36][37] - In Q4 2025, total revenues were up 13% year-on-year at $173 million, with licensing revenues accounting for 75% of the total [34][36] - Gross margin for the year finished at 61%, while Q4 gross margin was 66% [34][36] Business Line Data and Key Metrics Changes - Product revenues were driven by commercial momentum for the Humira biosimilar AVT02 and the Stelara biosimilar AVT04, which launched in the U.S. in Q1 2025 [36] - Product sales in Q4 were softer at $43 million, with a negative product margin of 37% due to timing of orders and planned facility upgrades [34][35] - The company has 30 biosimilars in development, representing over $185 billion in global sales potential [9][27] Market Data and Key Metrics Changes - In the U.S. market, Humira's originator share declined from approximately 70% at the beginning of 2025 to around 45% by year-end, indicating a shift towards biosimilars [18] - SIMLANDI holds about 9% of the U.S. market, making it the second-largest and one of the fastest-growing biosimilars in its segment [19] - In Europe, Uzpruvo has established a leading position with over 20% share of the biosimilar segment [19] Company Strategy and Development Direction - The company aims to strengthen its operational platform and expand its manufacturing footprint, including dual sourcing initiatives to enhance supply resilience [15][16] - Alvotech is focused on advancing its biosimilar portfolio towards approval and commercialization, particularly in the U.S. market [45][46] - The company anticipates continued growth in the biosimilar market, driven by the expected loss of patent protection for over 100 biologics in the next decade [7][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to address regulatory observations and expects to resubmit applications to the FDA in the second quarter of 2026 [4][26] - The company is positioned to benefit from recent FDA guidance that reduces the need for large efficacy trials, thereby lowering development costs and timelines [8][30] - The outlook for 2026 is reaffirmed with expected revenues in the range of $650-$700 million, reflecting continued double-digit sales growth [42][44] Other Important Information - The company raised close to $300 million from capital markets to support ongoing investments in development programs and manufacturing [17] - Alvotech's shares were listed on Nasdaq Stockholm, enhancing access to Nordic and European investors [17] Q&A Session Summary Question: U.S. approvals and pending items - Management confirmed completion of remediation efforts and is compiling information to support the upcoming submission, aiming for the first half of 2026 [49] Question: Guidance for 2026 - The lower end of the guidance does not include revenues from U.S. launches, while the upper end reflects potential growth from existing approvals [50][56] Question: Incremental commercial approvals needed - The guidance is based on momentum from existing approvals, with no new approvals factored in [56] Question: Manufacturing platform expansion - The company is evolving its dual sourcing strategy, with expected developments in the first half of the year [57] Question: Competitive landscape and risk mitigation - Management emphasized the importance of being first to market and strategic IP positioning to mitigate competitive exposure [68][69]

Financial Data and Key Metrics Changes - In 2025, total revenues increased by 20% to $591 million, while adjusted EBITDA rose by 27% to $137 million, reflecting strong financial performance [9][36] - For Q4 2025, total revenues were up 13% year-on-year at $173 million, with licensing revenues constituting 75% of the total [34][36] - The gross margin for the year was 61%, driven by the mix of licensing revenues [36] Business Line Data and Key Metrics Changes - The company has 30 biosimilars in development, representing over $185 billion in global sales potential [9][27] - Product revenues were $43 million in Q4 2025, with a negative product margin of 37% due to timing of orders and planned facility upgrades [34] - The commercial momentum for biosimilars like AVT02 and AVT04 is expected to continue into 2026, with AVT02 holding a 9% market share in the U.S. [75] Market Data and Key Metrics Changes - In the U.S. market, the originator of Humira held approximately 70% at the beginning of 2025, which declined to around 45% by year-end, indicating a shift towards biosimilars [18] - SIMLANDI has captured about 9% of the U.S. market, making it one of the fastest-growing biosimilars [19] - In Europe, Uzpruvo has established a leading position with over 20% share of the biosimilar segment [19] Company Strategy and Development Direction - The company aims to strengthen its operational platform and expand its manufacturing capabilities, including dual sourcing initiatives [5][15] - Alvotech is focused on advancing its biosimilar portfolio towards approval and commercialization, particularly in the U.S. market [45] - The company anticipates significant opportunities in the biosimilar market due to over 100 biologics expected to lose patent protection in the next decade [7][27] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in addressing regulatory observations from the FDA and expects to resubmit applications in Q2 2026 [4][26] - The company is well-positioned to benefit from recent FDA guidance that reduces the need for large efficacy trials, thus lowering development costs [8][30] - The outlook for 2026 is reaffirmed with expected revenues between $650 million and $700 million, reflecting continued double-digit growth [42] Other Important Information - The company raised close to $300 million from capital markets to support ongoing investments in development and manufacturing [17] - Alvotech's shares were listed on Nasdaq Stockholm, enhancing its presence in the Nordic and European markets [17] Q&A Session Summary Question: U.S. approvals and pending items - Management confirmed completion of remediation efforts and is compiling information to support the upcoming submission, aiming for the end of Q1 or early Q2 2026 [49] Question: Guidance for 2026 - The lower end of the revenue guidance does not include U.S. launch revenues, while the upper end reflects aspirations including potential U.S. launches [50][56] Question: Incremental commercial approvals needed - The guidance is based on momentum from existing approvals, with no new approvals factored in for the lower end of the range [56] Question: Manufacturing platform expansion - The expansion is expected to occur in the first half of 2026, with costs aligned with anticipated R&D expenditures [57] Question: Competitive landscape and risk mitigation - Management emphasized the importance of being first to market and strategic IP positioning to mitigate competitive exposure [68]

Financial Data and Key Metrics Changes - In 2025, total revenues increased by 20% to $591 million, while adjusted EBITDA rose by 27% to $137 million, reflecting strong financial performance [9][38] - For Q4 2025, total revenues were up 13% year-on-year at $173 million, with licensing revenues comprising 75% of the total [36][38] - The gross margin for the year was 61%, driven by the mix of licensing revenues [38] Business Line Data and Key Metrics Changes - The company has 30 biosimilars in development, representing over $185 billion in global sales potential [9][28] - Product revenues were driven by commercial momentum for the Humira biosimilar AVT02 and the Stelara biosimilar AVT04, which launched in the U.S. in Q1 2025 [38] - AVT-02 and AVT-04 are expected to continue growing, with AVT-02 holding approximately 9% of the U.S. market [19][76] Market Data and Key Metrics Changes - In the U.S. market, the originator of Humira held roughly 70% at the beginning of 2025, which declined to around 45% by year-end, indicating a shift towards biosimilars [18] - In Europe, the biosimilar Uzpruvo has established a leading position with over 20% share of the biosimilar segment [19] - The U.S. biosimilar market now accounts for approximately 40% of the total market, with continued growth expected [19] Company Strategy and Development Direction - The company aims to strengthen its operational platform and expand its manufacturing footprint, including dual sourcing initiatives [5][14] - Alvotech is focused on advancing its biosimilar portfolio towards approval and commercialization, particularly in the U.S. market [47] - The company anticipates significant opportunities in the biosimilar market due to over 100 biologics expected to lose patent protection in the next decade [28] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to address regulatory observations and expects to resubmit applications to the FDA in Q2 2026 [4][27] - The company is well-positioned to benefit from recent FDA guidance changes that reduce the need for large efficacy trials, thus lowering development costs [8][32] - The outlook for 2026 is reaffirmed with expected revenues in the range of $650-$700 million, reflecting continued double-digit sales growth [44] Other Important Information - The company raised close to $300 million from capital markets to support ongoing investments in development and manufacturing [17] - Alvotech's shares were listed on Nasdaq Stockholm, enhancing its presence in the Nordic and European markets [17] Q&A Session Summary Question: Status of U.S. approvals and pending items - The company completed its remediation efforts and is compiling information to demonstrate effectiveness before submission, aiming for the first half of 2026 [51][52] Question: Guidance for 2026 and U.S. product assumptions - The lower end of the 2026 revenue guidance does not include revenues from U.S. launches, while the upper end reflects aspirations for growth [53][56] Question: Incremental commercial approvals needed for guidance - The guidance is based on momentum from existing approvals, with no new approvals built into the lower end of the range [58] Question: Expansion of manufacturing platform and associated costs - The dual sourcing initiative is expected to be secured in the first half of 2026, with costs anticipated to align with existing R&D expenditure [59][60] Question: Competitive landscape and mitigation strategies - The company aims to be first to market with its biosimilars, leveraging strategic IP positioning and partnerships to mitigate competitive exposure [68][69] Question: Sales trends for AVT02 and growth expectations - The company anticipates continued growth for AVT02 and AVT04, despite some challenges in the European market [75][76]

Full Year and Q4 2025 Earnings Presentation 19 MARCH 2026 z z Disclaimer This presentation ("Presentation") does not contain or constitute an offer to sell, a solicitation of an offer to buy, or a recommendation to purchase any security of Alvotech (the "Company") to any person in the United States or in any jurisdiction to whom or in which such offer or solicitation is unlawful. Any trademarks, servicemarks, trade names and copyrights of the Company and other companies contained in this Presentation are th ...

Core Insights - Alvotech reported total revenues of $593 million for FY 2025, reflecting a 21% year-on-year increase [3] - The company has launched three newly approved biosimilars and has a pipeline of 30 biosimilars in development [5][6] - Alvotech anticipates total revenues of $650-700 million for 2026, with adjusted EBITDA expected to rise to $180-220 million [11] Financial Performance - Total revenues for Q4 2025 were $173 million, a 13% increase year-on-year [7] - Adjusted EBITDA for FY 2025 was $137 million, up 27% year-on-year, with a gross margin of 61% [7] - The cash balance as of December 31, 2025, was $172 million [7] Product Development and Approvals - Alvotech has five approved biosimilars on the market, including products referencing Humira®, Stelara®, and Simponi® [18] - Recent approvals include AVT05 as a biosimilar to Simponi® and AVT03 as a biosimilar to Prolia® and Xgeva® in the EEA [7] - The company expects to receive U.S. approval for four Biologics License Applications by late 2026 [12] Strategic Initiatives - Alvotech raised nearly $300 million from capital markets to support its development programs and manufacturing platform [6] - The company has expanded its global reach through new commercial partnerships and acquisitions, including the R&D organization of Xbrane in Sweden [6][7] - Leadership changes include the appointment of Lisa Graver as Chief Executive Officer and other key management roles [10] Market Outlook - Management reaffirms its outlook for 2026, focusing on cash flow and margin expansion [11] - The anticipated revenue range for 2026 reflects continued double-digit sales growth [11] - The company is addressing regulatory observations from the FDA inspection of its Reykjavik manufacturing facility and plans to resubmit applications in Q2 2026 [9]