Attached is a copy of a filing with the Luxembourg Commission de Surveillance du Secteur Financier (CSSF) regarding transactions of managers and closely associated persons, announcing the acquisition at the market opening of 320,000 shares in Alvotech at ISK 1,255 per share, by Robert Wessman, Chairman and CEO. ...

Financial Data and Key Metrics Changes - Alvotech raised its full-year revenue guidance for 2025 to $600 million to $700 million and adjusted EBITDA guidance to $200 million to $280 million [7][39] - The company achieved $110 million in product revenues during Q1 2025, an increase of $97 million or 784% compared to the same period in the prior year [30][31] - Adjusted EBITDA for Q1 2025 was $21 million, compared to negative adjusted EBITDA of $38 million for the same period in the prior year [39] Business Line Data and Key Metrics Changes - The Stellara biosimilar was launched in the U.S. market in late February 2025, following successful launches in Europe, Japan, and Canada [8][9] - Alvotech's biosimilar to Humira saw strong uptake in the U.S. market, with a penetration rate of at least 21% by year-end 2024 [20][21] - The company expects to move from two marketed biosimilars to six by early 2026, with three biosimilar filings under review in major markets [11][27] Market Data and Key Metrics Changes - In the U.S. market, Alvotech's Humira biosimilar represented about 12% of total demand for Humira and Humira biosimilars in 2024 [19][21] - The European Stellara market expanded by 9% year-over-year due to the entry of biosimilars, with Alvotech aiming for a double-digit market share by the end of 2025 [23] - Alvotech is the only developer to launch a Stellara biosimilar in Japan, indicating a strong competitive position in that market [24] Company Strategy and Development Direction - Alvotech plans to significantly increase the pace of development, moving four to six new biosimilar candidates into in-house process development each year [12] - The company is focused on a B2B model, which allows it to address a global patient population through 20 strategic commercial partnerships across 90 markets [12] - Alvotech aims to maintain a focus on quality and reliability rather than sacrificing value for market share in a competitive environment [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of the Stellara biosimilar in the U.S. market, especially after receiving the interchangeable designation [45] - The company anticipates that if tariffs on pharmaceuticals are applied, they will not disrupt operations or competitiveness in the U.S. market [13] - Management expects to be free cash flow positive in 2025, marking a significant milestone for the company [40] Other Important Information - Alvotech's net debt stood at $1.058 billion as of March 31, 2025, with expectations of mid-single-digit leverage by year-end [41] - The company closed the period with 301.9 million shares outstanding, including unvested earn-out shares [42] Q&A Session Summary Question: Can you clarify the interchangeable exclusivity and its implications? - Management confirmed the receipt of the interchangeable designation and noted that while some competitors may also obtain it, this designation is expected to drive faster uptake of their product [45][46] Question: What is the impact of stocking on the Stellara biosimilar sales? - Management clarified that the sales figures are driven by timing of orders rather than stocking, as they operate on a B2B model [50][51]

Financial Data and Key Metrics Changes - The company raised its full-year revenue guidance for 2025 to $600 million to $700 million and adjusted EBITDA guidance to $200 million to $280 million [6][39] - In Q1 2025, the company achieved $110 million in product revenues, an increase of $97 million or 784% compared to the same period in the previous year [30][31] - Adjusted EBITDA for Q1 2025 was $21 million, compared to negative adjusted EBITDA of $38 million for the same period in the prior year [38] Business Line Data and Key Metrics Changes - The company launched its Stellara biosimilar in the U.S. market in late February 2025, following successful launches in Europe, Japan, and Canada [7][8] - The biosimilar to Humira saw a strong uptake in the U.S. market, with a penetration rate of at least 21% by year-end 2024 [20][21] - The company expects to move from two marketed biosimilars to six by early 2026, with three biosimilar filings under review in major markets [10][11] Market Data and Key Metrics Changes - The total addressable market for the company is estimated at over $185 billion, not including 15 unique molecules already in development [15] - The company holds either the highest or second highest market share in multiple European markets for its Stellara biosimilar [22][23] - The U.S. market for Humira biosimilars is expected to convert at least 50% to biosimilars by the end of 2025 [20] Company Strategy and Development Direction - The company plans to increase the pace of development significantly, moving four to six new biosimilar candidates into in-house process development each year [12] - The company emphasizes a B2B model, allowing it to address a global patient population through 20 strategic commercial partnerships across 90 markets [12] - The company aims to maintain a focus on quality and service rather than sacrificing value for market share [25] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the growth potential of the Stellara biosimilar in the U.S. market following the FDA's approval for interchangeability [8][24] - The company anticipates that potential U.S. tariffs on pharmaceuticals will not disrupt its operations or customer competitiveness [13][14] - Management expects to be free cash flow positive in 2025, marking a significant milestone for the company [40][41] Other Important Information - The company closed the period ending March 31 with $1.058 billion in net debt and expects leverage to be in the mid-single-digit range by year-end [41] - The company has a robust order book for its biosimilars, particularly in Europe, and anticipates significant revenue from milestone achievements in the second half of the year [37][39] Q&A Session Summary Question: Clarification on interchangeable exclusivity for Stellara biosimilar - Management confirmed the receipt of the interchangeable designation and noted that while competitors may also seek this designation, it is expected to drive faster uptake for their product [45][46] Question: Quantification of stocking impact on Stellara biosimilar sales - Management clarified that the sales figures are driven by timing of orders rather than stocking, as they operate on a B2B model [50][51]

Core Viewpoint - Alvotech intends to list Swedish Depository Receipts (SDRs) on Nasdaq Stockholm to broaden its investor base and enhance visibility among Nordic and European institutional investors following the acquisition of Xbrane Biopharma AB's R&D operations [2][3][8] Offering Details - The Offering will be directed solely into Sweden during an application period from May 9–16, 2025, with a maximum price of SEK 90 per SDR [6][12] - The gross proceeds are estimated to be approximately SEK 30 million, with 441,600 SDRs offered, each representing one Share [6][12] - The first day of trading on Nasdaq Stockholm is expected to be May 19, 2025 [6][12] Strategic Importance - The acquisition of Xbrane's R&D operations is a strategic priority to enhance Alvotech's R&D capabilities and establish a strong presence in the Swedish life-science sector [5][8] - The integration of Xbrane's workforce will expand Alvotech's scientific and innovation capabilities, allowing access to a broader talent pool [5][8] Market Positioning - The listing on Nasdaq Stockholm is expected to strengthen Alvotech's recognition in Nordic and European markets, improving access to regional capital and attracting a broader base of institutional and retail investors [3][8] - Alvotech aims to be a global leader in the biosimilar space, with a current pipeline that includes nine disclosed biosimilar candidates targeting various diseases [13][14] Investor Engagement - A free conversion period will be offered to existing shareholders to convert their Shares into SDRs, with conversion fees covered by Alvotech for one year from the first trading day [9][10] - A prospectus detailing the Offering has been published and is available on Alvotech's website and other financial platforms [10][11]

Financial Performance & Outlook - Alvotech's revised outlook for 2025 projects revenues between $600 million and $700 million, including product revenue of $340 million to $410 million and milestone revenues of $260 million to $290 million[12] - The company anticipates an adjusted EBITDA of $200 million to $280 million in 2025[12] - Alvotech expects a product margin of 38-41% and a gross margin of 65-66%[12] - Q1 2025 product revenue reached $110 million, a 784% increase compared to $12 million in Q1 2024[34] - Total revenue for Q1 2025 was $133 million, a 260% increase from $37 million in Q1 2024[34] Product Pipeline & Commercialization - Alvotech has a robust pipeline of biosimilar candidates, including AVT02 (adalimumab), AVT04 (ustekinumab), and others in various stages of development and commercialization[23] - The company expects >50% of the U S Humira® market to convert to biosimilars before the end of 2025[25] - SELARSDI® (Stelara® biosimilar) has been approved in the U S as an interchangeable biosimilar for all presentations[25] Cash Flow & Capital Structure - Alvotech had cash and cash equivalents of $39 million as of March 31, 2025, with total borrowings of $1,097 million[40] - The company anticipates being free cash flow positive in 2025 based on current operating plans[40] - As of March 31, 2025, there were 301.9 million common shares outstanding[40]

Core Insights - Alvotech reported strong financial results for Q1 2025, with significant increases in product revenue and adjusted EBITDA, indicating robust growth and operational efficiency [2][7][17]. Financial Performance - Total revenues for Q1 2025 reached $132.8 million, a 260% increase from $36.9 million in Q1 2024 [7]. - Product revenue was $109.9 million, representing a 786% increase compared to $12.4 million in the same period last year [7]. - Adjusted EBITDA for Q1 2025 was $20.5 million, a significant recovery from a negative $38.4 million in Q1 2024 [7]. - The company had cash and cash equivalents of $39.5 million as of March 31, 2025, with total borrowings of $1,096.7 million [6]. Business Developments - Alvotech launched SELARSDI™, a biosimilar to Stelara®, in the U.S., and received interchangeability status effective April 30, 2025 [3]. - The company announced the acceptance of U.S. Biologics License Applications (BLAs) for AVT05 and AVT06, proposed biosimilars to Simponi® and Eylea®, respectively [3]. - Alvotech acquired Xbrane's R&D operations in Sweden and all rights to a biosimilar candidate referencing Cimzia® [5]. Pipeline Expansion - The company is focused on launching four new biosimilars as key near-term priorities and is expanding its development pipeline [2]. - Alvotech's acquisition of Xbrane is expected to enhance its R&D capabilities and strengthen its position in the biosimilar market [2]. Cost Management - Cost of product revenue increased to $65.4 million in Q1 2025 from $20.0 million in Q1 2024, driven by higher sales [10]. - Research and development expenses decreased to $38.2 million in Q1 2025 from $49.9 million in Q1 2024, reflecting a shift towards commercialization [11]. Profitability - Operating profit for Q1 2025 was $10.6 million, a turnaround from an operating loss of $48.4 million in the same period last year [13]. - Reported net profit was $109.7 million, or $0.39 per share, compared to a net loss of $218.7 million, or ($0.89) per share, in Q1 2024 [17].

Total Revenues in the first quarter of 2025 reached $132.8 million, compared to $36.9 million in the same period last year, representing a 260% increase Product Revenues in the first in the first quarter of 2025 reached $109.9 million, compared to $12.4 million in the same period last year, representing a 786% increase Adjusted EBITDA in the first quarter of 2025 was $20.5 million compared to negative $38.4 million in 2023 Full year guidance increased to $600-$700 million in top line revenue and $200-280 mi ...

Core Viewpoint - Alvotech anticipates that potential U.S. tariffs on imported pharmaceuticals will have minimal impact on its product revenues in 2025, estimating the effect of a 10% tariff to be less than 1% of total expected revenues [1][2]. Group 1: Tariff Impact - Alvotech manufactures its biosimilars in Iceland, which currently faces a minimum tariff of 10% on goods imported to the U.S. [1][2] - The estimated impact of a 10% tariff on Alvotech's sales to the U.S. in the second half of 2025 would be less than 1% of expected product revenues [2]. - Customers are responsible for all costs of transport and import duties to the U.S., meaning Alvotech will not bear these costs [1][2]. Group 2: Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space [3]. - The company has two approved biosimilars, Humira® (adalimumab) and Stelara® (ustekinumab), and a pipeline of nine disclosed biosimilar candidates targeting various diseases [3]. - Alvotech has established strategic commercial partnerships across multiple regions, including the U.S., Europe, Japan, and parts of Asia and South America [3].

Core Viewpoint - Alvotech anticipates that potential U.S. tariffs on imported pharmaceuticals will have minimal impact on its product revenues in 2025, estimating the effect of a 10% tariff to be less than 1% of expected total product revenues [1][2]. Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar space by providing high-quality, cost-effective products [3]. - The company has two approved biosimilars, Humira® (adalimumab) and Stelara® (ustekinumab), and a pipeline of nine disclosed biosimilar candidates targeting various diseases [3]. - Alvotech has established strategic commercial partnerships across multiple regions, including the U.S., Europe, Japan, and parts of South America, Africa, and the Middle East [3]. Tariff Impact Analysis - The company manufactures its biosimilars in Iceland, which currently faces a minimum tariff of 10% on goods imported to the U.S. [1][2]. - According to the company's estimates, the impact of a 10% tariff on U.S. sales in the second half of the year would be less than 1% of expected product revenues in 2025, with costs not borne by Alvotech due to contractual terms [2]. - Looking beyond 2025, the anticipated impact of tariffs is expected to remain a low single-digit percentage of total product revenues, considering future product launches and increased sales [2].

Core Viewpoint - The FDA has approved Teva Pharmaceutical Industries Ltd. and Alvotech's Selarsdi as an interchangeable biosimilar to Johnson & Johnson's Stelara, expanding treatment options for various inflammatory conditions [1][2]. Group 1: Product Approval and Details - Selarsdi is approved for multiple indications, including adult and pediatric psoriatic arthritis, plaque psoriasis, Crohn's disease, and ulcerative colitis, effective from April 30, 2025 [1]. - The approved presentations of Selarsdi include 45 mg/0.5 mL and 90 mg/mL in prefilled syringes, 45 mg/0.5 mL in vials, and 130 mg/26 mL for intravenous infusion [3]. Group 2: Strategic Partnerships and Market Position - Teva and Alvotech entered a strategic partnership in August 2020 to exclusively commercialize five biosimilar candidates, which was later extended to include additional products [4]. - Teva's recent launches of Selarsdi and another biosimilar, along with a robust pipeline, position the company for strong leadership in the biosimilars market [2]. Group 3: Financial Impact and Stock Performance - Following the news of the approval, TEVA stock increased by 2.10% to $16.53, while ALVO stock rose by 0.67% to $8.22 [5]. Group 4: Future Developments - The FDA has accepted Biologics License Applications for three additional biosimilar candidates developed by Alvotech in partnership with Teva, with goal dates for approval in Q4 2025 [6].