Core Insights - Alvotech, a global biotech company, specializes in the development and manufacture of biosimilar medicines and will participate in the Morgan Stanley 23rd Annual Global Healthcare Conference in New York from September 8-10, 2025 [1][2] Company Overview - Alvotech was founded by Robert Wessman and aims to be a leader in the biosimilar market by providing high-quality, cost-effective products and services through a fully integrated approach [3] - The company has launched two biosimilars and has a development pipeline targeting treatments for autoimmune disorders, eye disorders, osteoporosis, respiratory diseases, and cancer [3] - Alvotech has established a network of strategic commercial partnerships across various regions, including the United States, Europe, Japan, China, and parts of South America, Africa, and the Middle East [3] - Notable commercial partners include Teva Pharmaceuticals, STADA Arzneimittel AG, Fuji Pharma Co., Ltd, and Dr. Reddy's, among others, each covering unique products and territories [3]

Core Viewpoint - The European Commission has approved Mynzepli® as a biosimilar to Eylea® (aflibercept), enhancing access to effective therapies for retinal diseases across Europe [1][3]. Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar space with a pipeline of eight disclosed candidates targeting various diseases [9]. - Advanz Pharma is a UK-based global pharmaceutical company that specializes in specialty, hospital, and rare disease medicines, with a commercial presence in over 90 countries [10]. Product Details - Mynzepli® is approved for treating multiple retinal diseases, including neovascular age-related macular degeneration (AMD) and diabetic macular edema (DME), available in a 40 mg/mL solution for injection [4][8]. - The approval is based on comprehensive data demonstrating the therapeutic equivalence of Mynzepli® to Eylea® [5][8]. Market Context - In 2024, global sales of Eylea® were approximately US$9 billion, with one-third of these sales occurring in Europe, indicating a significant market opportunity for Mynzepli® [3]. - The centralized marketing authorization for Mynzepli® is valid across all European Economic Area (EEA) countries, including the 27 EU member states, Norway, Iceland, and Lichtenstein [3].

Company Overview - Alvotech is a global biotech company focused on the development and manufacture of biosimilar medicines for patients worldwide [5] - The company aims to be a leader in the biosimilar space by delivering high-quality, cost-effective products and services through a fully integrated approach [5] - Alvotech has two approved biosimilars, Humira® (adalimumab) and Stelara® (ustekinumab), marketed in multiple global markets [5] - The current development pipeline includes nine disclosed biosimilar candidates targeting various conditions such as autoimmune disorders, eye disorders, osteoporosis, respiratory disease, and cancer [5] Recent Developments - Patrik Ling has joined Alvotech as VP Investor Relations Scandinavia, based in Stockholm [1] - Ling has over 25 years of experience in the life-science industry, previously serving as a Senior Equity Analyst at DNB Carnegie [2] - His expertise in both pharmaceuticals and finance is expected to enhance Alvotech's efforts to broaden its shareholder base in Scandinavia [3] Strategic Focus - Alvotech is expanding its portfolio of products and has established a new base of R&D operations in Sweden [4] - The company emphasizes the importance of biosimilars in meeting the growing demand for high-quality biologics and controlling healthcare costs [4] - Alvotech has formed strategic commercial partnerships to enhance its global reach and leverage local expertise across various markets, including the US, Europe, Japan, China, and parts of South America, Africa, and the Middle East [5]

Financial Data and Key Metrics Changes - The company reported a 30% year-on-year increase in revenues for the first half of 2025, reaching $306 million compared to $236 million in the same period last year [23] - Product revenues grew over 200% in the first half of the year, with a 77% year-on-year increase in Q2 2025 [9][23] - Adjusted EBITDA for the first half was $54 million, down from $64 million in the same period last year, with Q2 adjusted EBITDA at $18 million compared to $102 million in Q2 last year [26] Business Line Data and Key Metrics Changes - The biosimilar to Humira, marketed as Simlanti in the US, achieved over 40% market share in the US Humira market as of July, with expectations to reach 50% by year-end [11][12] - The biosimilar to Stellara, marketed as Selarsty in the US, reached over 20% market share in the US as of July, with strong performance in Europe [14][52] Market Data and Key Metrics Changes - The company has gained marketing approvals in 67 markets globally, with biosimilars to Humira being sold in 33 markets [13] - The company continues to expand its market presence, particularly in Europe, where it has seen significant growth in biosimilar penetration [49] Company Strategy and Development Direction - The company plans to ramp up R&D efforts significantly, expanding its pipeline with new partnerships and acquisitions [17][19] - The focus is on product margin rather than volume, with a strategy to maintain sustainable pricing in competitive markets [15] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong momentum going into the second half of the year, despite expected softness in Q3 revenues [36] - The company anticipates a stronger Q4, driven by new product launches and milestone revenues [36][62] Other Important Information - The company completed the acquisition of IVS Lee in Switzerland, enhancing its capabilities in assembly and packaging [19][28] - The listing on NASDAQ Stockholm has broadened the shareholder base and increased trading liquidity [20] Q&A Session Summary Question: Confidence in top line guidance going forward - Management indicated strong momentum in Q2 and the first half, but expects Q3 to be softer with a stronger Q4 anticipated [34][36] Question: Growth potential for Simlanti in the US - Management confirmed a valid contract with Qualant, but noted that the focus is on value rather than volume, expecting challenges in the second half [37] Question: FDA inspections and approval timelines - Management stated that they will keep the market informed about FDA inspection outcomes and remain confident in targeting approval dates [39][60] Question: Guidance on revenue and EBITDA for the year - Management reiterated that guidance remains intact, with expectations for a strong Q4 to offset any softness in Q3 [46][62] Question: Market share expectations for Humira and Stellara - Management expects continued growth in market share for both products, particularly in Europe and the US [48][52]

Financial Data and Key Metrics Changes - The company reported a 30% year-on-year increase in revenues for the first half of 2025, reaching $306 million compared to $236 million in the same period last year [20] - Product revenues grew over 200% in the first half of the year, with Q2 2025 product revenues increasing by 77% year-on-year [6][20] - Adjusted EBITDA for the first half was $54 million, down from $64 million in the prior year, with Q2 adjusted EBITDA at $18 million compared to $102 million in Q2 last year [23] Business Line Data and Key Metrics Changes - The biosimilar to Humira, marketed as Simlanti in the U.S. and Hukyndra in Europe, has gained over 40% market share in the U.S. Humira market as of July, with expectations to reach 50% by year-end [9][10] - The biosimilar to Stellara, marketed as Selarsty in the U.S. and OOSH Provo in Europe, has achieved over 20% market share in the U.S. as of July, with strong performance in Europe [12][50] Market Data and Key Metrics Changes - The company has gained marketing approvals in 67 markets globally and is selling its Humira biosimilar in 33 markets [10] - In Europe, the company continues to see significant market share growth, particularly in France, where biosimilar penetration is still low [46] Company Strategy and Development Direction - The company plans to ramp up R&D efforts significantly, expanding its pipeline and has completed acquisitions to enhance its capabilities [14][25] - The focus remains on product margin rather than volume, with a strategy to drive sustainable growth through operational efficiencies and new product launches [12][26] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the strong momentum observed in Q2 and the first half of the year, despite anticipating a softer Q3 due to the timing of milestone revenues [33][34] - The company remains committed to maintaining its guidance and expects Q4 to be the strongest quarter of the year [44][61] Other Important Information - The company completed the acquisition of IVS Lee in Switzerland, enhancing its control over the value chain [16][25] - The listing on NASDAQ Stockholm has broadened the shareholder base and increased trading liquidity [17] Q&A Session Summary Question: Confidence in top line guidance going forward - Management noted strong momentum in Q2 and the first half, but expects product revenues and milestone revenues to soften in Q3, with a stronger Q4 anticipated [32][34] Question: Growth potential for Cymlandi in the U.S. - Management confirmed a valid contract with Qualant but indicated that the focus is on value rather than volume, expecting challenges in the second half [36] Question: FDA inspections and potential delays - Management acknowledged the routine nature of FDA inspections and committed to keeping the market informed about product approvals [38] Question: Guidance on revenue and EBITDA - Management reiterated that the guidance remains intact, with expectations for a strong Q4 to offset any softness in Q3 [44][61] Question: Market share expectations for Humira and Stellara - Management indicated a strong position in both markets, with expectations for continued growth in market share [46][50]

Financial Performance - Product revenue increased by 211% from $66 million in H1 2024 to $205 million in H1 2025[18] - Total revenue increased by 30% from $236 million in H1 2024 to $306 million in H1 2025[18] - Licensing revenue decreased by 40% from $170 million in H1 2024 to $101 million in H1 2025[18] - Gross profit decreased by 2% from $171 million in H1 2024 to $168 million in H1 2025[18] - EBITDA decreased by 16% from $64 million in H1 2024 to $54 million in H1 2025[18] - Strong cash flow from operations of $77 million, an improvement of $161 million year-on-year[22] - Cash and cash equivalents of $151 million as of June 30, 2025[22] - Total borrowings of $1,118 million as of June 30, 2025[22] Market and Product Updates - Biosimilar to Humira® has the 2nd largest market share for Humira® biosimilars in the U S[13] - Biosimilar to Stelara® continues to outperform in Europe with first or second largest share in each market where product has been launched[13] Strategic Partnerships and Acquisitions - Expanded partnership with Advanz to include four new biosimilars from early-stage pipeline[13] - Partnered with Dr Reddy's to jointly develop biosimilar candidate to Keytruda®[13] - Completed acquisition of Ivers-Lee in July, increasing capabilities and flexibility in assembly and packaging[13]

Core Viewpoint - Alvotech reported quarterly earnings of $0.14 per share, significantly beating the Zacks Consensus Estimate of a loss of $0.26 per share, marking an earnings surprise of +153.85% [1] Financial Performance - The company posted revenues of $173.34 million for the quarter ended June 2025, exceeding the Zacks Consensus Estimate by 50.56%, although this represents a decline from year-ago revenues of $198.75 million [2] - Over the last four quarters, Alvotech has surpassed consensus EPS estimates three times and topped consensus revenue estimates four times [2] Stock Performance - Alvotech shares have declined approximately 34.6% since the beginning of the year, contrasting with the S&P 500's gain of 9.6% [3] Future Outlook - The company's earnings outlook will be crucial for determining the stock's immediate price movement, with current consensus EPS estimates at -$0.22 for the coming quarter and $0.18 for the current fiscal year [4][7] - The estimate revisions trend for Alvotech was favorable ahead of the earnings release, resulting in a Zacks Rank 1 (Strong Buy) for the stock, indicating expected outperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which Alvotech belongs, is currently ranked in the bottom 41% of over 250 Zacks industries, which may impact stock performance [8]

Alvotech _____________________ Unaudited Condensed Consolidated Interim Financial Statements as of 30 June 2025 and for the six months ended 30 June 2025 and 2024 Table of Contents These Unaudited Condensed Consolidated Interim Financial Statements for the six-month period ended 30 June 2025 have not been audited by an external auditor. Financial results for the six months ended 30 June 2025. As of 30 June 2025, the Company had $151.5 million in cash and cash equivalents. In addition, the Company had borrow ...

Core Insights - Alvotech reported a significant increase in product revenues, with over 200% growth year-on-year, marking the best quarter in terms of operating cash flows in the company's history [2][7] - The company has expanded its commercial partnerships and made strategic acquisitions to enhance its biosimilar pipeline, including the acquisition of Xbrane's R&D facilities and Ivers-Lee Group [2][4] - Alvotech's financial results for the first half of 2025 show a net profit of $141.7 million, a substantial recovery from a net loss of $153.5 million in the same period of 2024 [21][43] Financial Performance - Product revenue reached $204.7 million for the first six months of 2025, compared to $65.9 million in the same period of 2024, driven by the sales expansion of AVT02 and AVT04 [10] - License and other revenue decreased to $101.3 million from $169.7 million year-on-year, primarily due to the timing of milestone achievements [11] - Operating profit was $28.6 million, down from $43.4 million in the prior year, reflecting the timing of milestone-related revenue [15] Cost Structure - Cost of product revenue increased to $139.3 million from $65.2 million, attributed to higher sales volumes [12] - Research and development expenses slightly decreased to $92.9 million from $97.5 million, reflecting the transition of several programs out of the clinical phase [13] - General and administrative expenses rose to $45.3 million from $29.6 million, driven by increased third-party service costs [14] Cash Flow and Liquidity - As of June 30, 2025, Alvotech had cash and cash equivalents of $151.5 million, significantly improved from $51.4 million at the end of 2024 [9] - The company generated net cash from operating activities of $68.3 million, a recovery from a net cash used of $126 million in the same period of 2024 [47] Strategic Partnerships and Acquisitions - Alvotech entered into commercial agreements with Advanz Pharma and Dr. Reddy's Laboratories to co-develop multiple biosimilar candidates [3] - The acquisition of Xbrane's R&D organization and Ivers-Lee Group is expected to enhance Alvotech's development capabilities and operational efficiency [4][8] Market Position and Future Outlook - Alvotech aims to solidify its position as a leader in the biosimilar market by leveraging its expanded pipeline and strategic partnerships [37] - The company plans to conduct a business update conference call to discuss its performance and future strategies [22]

Core Insights - Alvotech reported a significant increase in product revenues, with over 200% growth year-on-year, marking the best quarter in terms of operating cash flows in the company's history [2][8] - The company has expanded its commercial partnerships and made strategic acquisitions to enhance its biosimilar pipeline, including the acquisition of Xbrane's R&D facilities and Ivers-Lee Group [2][4] - Alvotech's financial results for the first half of 2025 show a net profit of $141.7 million, a substantial recovery from a net loss of $153.5 million in the same period of 2024 [23][10] Financial Performance - Product revenue reached $204.7 million for the first six months of 2025, compared to $65.9 million in the same period of 2024, driven by the sales expansion of AVT02 and AVT04 [11] - License and other revenue decreased to $101.3 million from $169.7 million year-on-year, primarily due to the timing of milestone achievements [12] - Operating profit was $28.6 million, down from $43.4 million in the prior year, reflecting the timing of milestone-related revenue [16] Cost Structure - Cost of product revenue increased to $139.3 million from $65.2 million, attributed to higher sales volumes [13] - Research and development expenses slightly decreased to $92.9 million from $97.5 million, reflecting the transition of several programs out of the clinical phase [14] - General and administrative expenses rose to $45.3 million from $29.6 million, driven by increased third-party service costs [15] Cash Flow and Liquidity - As of June 30, 2025, Alvotech had cash and cash equivalents of $151.5 million, significantly improved from $51.4 million at the end of 2024 [10] - The company generated net cash from operating activities of $68.3 million, a turnaround from a cash outflow of $126 million in the previous year [46] Strategic Partnerships and Acquisitions - Alvotech entered into commercial agreements with Advanz Pharma for four biosimilar candidates and a collaboration with Dr. Reddy's Laboratories for AVT32 [3] - The acquisition of Xbrane's R&D organization and Ivers-Lee Group is expected to enhance Alvotech's development capabilities and operational efficiency [4][9] Market Position and Future Outlook - Alvotech aims to be a leader in the biosimilar market, with a pipeline that includes nine disclosed biosimilar candidates targeting various diseases [38] - The company plans to continue its strategic investments in commercialization and regulatory advancements to support long-term growth [16][2]