Strong performance driven by over 200% growth in product revenues year-on-year Best quarter in Alvotech’s history in terms of operating cash flowsContinued expansion of commercial partnerships for pipeline assetsAlvotech listed on Nasdaq Stockholm MarketConference call and live webcast on Thursday August 14, 2025, 8:00 am ET (12:00pm GMT) REYKJAVIK, Iceland, August 13, 2025 - Alvotech (NASDAQ: ALVO, or the “Company”), a global biotech company specializing in the development and manufacture of biosimilar med ...

Core Viewpoint - The FDA has approved Amphastar Pharmaceuticals' Iron Sucrose Injection, which is expected to generate significant sales in the treatment of iron deficiency anemia in patients with chronic kidney disease [1][5]. Group 1: FDA Approval and Market Potential - Amphastar Pharmaceuticals received FDA approval for its Iron Sucrose Injection in various dosages, which is indicated for treating iron deficiency anemia in chronic kidney disease patients [1]. - The U.S. sales for the branded competitor, Venofer, were approximately $513 million for the 12 months ending June 30, 2025, indicating a substantial market opportunity for Amphastar [3]. - Analyst estimates suggest that Amphastar's product could capture about two-thirds of the Venofer market, potentially leading to sales of $80 million to $100 million [5]. Group 2: Financial Performance and Analyst Ratings - Amphastar reported adjusted earnings of 85 cents, surpassing the consensus estimate of 76 cents, while sales fell 4% year-over-year to $174.41 million, slightly above the consensus of $174.25 million [7]. - Analyst Serge Belanger upgraded Amphastar to a Buy rating from Hold, with a price forecast of $36, citing attractive valuation and growth potential for 2025 and 2026 [6]. Group 3: Strategic Partnerships and Future Developments - Amphastar announced an exclusive license agreement with Nanjing Anji Biotechnology to develop and commercialize three proprietary peptides, with potential total payments to Anji reaching up to $453 million [8][9]. - The agreement includes an upfront payment of $5.25 million and additional milestone payments, indicating a strategic move to expand its product portfolio [9].

Core Viewpoint - Alvotech has announced the acquisition of Ivers-Lee Group to expand its assembly and packaging capacity, supporting its growth plans in the biosimilar market [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 with a fully integrated approach and broad in-house capabilities [6]. - The company has two approved biosimilars, Humira (adalimumab) and Stelara (ustekinumab), and a pipeline of nine disclosed biosimilar candidates targeting various diseases [6]. Acquisition Details - Ivers-Lee, a family-owned business established in 1947, specializes in high-quality assembly and packaging services for the pharmaceutical sector and will be integrated into Alvotech's Technical Operations division [3][5]. - The acquisition is expected to provide Alvotech with added flexibility and capacity to meet the increasing global demand for biosimilars, particularly as the company prepares to launch three new biosimilars in 2025 [2][4]. Operational Integration - Ivers-Lee's operations will continue to service its existing clients while also integrating capabilities such as the assembly and packaging of autoinjectors, pre-filled syringes, and safety devices [5]. - Peter Schüpbach, managing director of Ivers-Lee, will join Alvotech's Technical Operations senior leadership team post-acquisition, ensuring continuity in management [3]. Market Position - Alvotech has formed strategic commercial partnerships across various global markets, including the United States, Europe, Japan, and parts of South America, enhancing its market reach and local expertise [6].

Core Insights - Dr. Reddy's Laboratories (RDY) has entered into a collaboration and license agreement with Alvotech (ALVO) to co-develop and commercialize a biosimilar candidate to Merck's Keytruda, a leading PD-L1 inhibitor [1][8] Group 1: Collaboration Details - The agreement entails that RDY and ALVO will jointly share all costs associated with the development and manufacturing of the biosimilar candidate [3] - Both companies will retain the rights to commercialize the product globally upon successful development [3][8] Group 2: Market Impact - The collaboration is expected to significantly enhance Dr. Reddy's biosimilar portfolio, particularly in emerging markets, and strengthen its capabilities in oncology [4][8] - Keytruda generated sales of $29.5 billion in 2024, with a year-over-year growth of 6% to $7.21 billion in Q1 2025, highlighting the potential market opportunity for the biosimilar [2] Group 3: Previous Agreements - RDY and ALVO had previously signed a license and supply agreement in 2024 for the commercialization of AVT03, a biosimilar candidate to Amgen's Prolia and Xgeva [9] - The FDA accepted a regulatory filing for AVT03 in March 2025, indicating progress in their biosimilar development efforts [9][10] Group 4: Strategic Focus - The introduction of AVT03 could enhance patient access to affordable treatment options for osteoporosis and other bone-related conditions, addressing a significant healthcare need [11][12] - Dr. Reddy's is actively diversifying its generics portfolio to strengthen its market position [12]

Core Viewpoint - Alvotech, a global biotech company focused on biosimilar medicines, successfully completed an oversubscribed offering of Swedish Depository Receipts (SDRs) in connection with its listing on Nasdaq Stockholm, which is expected to enhance its market presence and access to capital [2][5][8]. Offering Details - The offering attracted strong interest, resulting in over 3,000 new shareholders and was multiple times oversubscribed [2][8]. - The final price per SDR was set at SEK 87.51, reflecting a 10% discount from the volume-weighted average price of the ordinary shares during the application period [8]. - The gross proceeds from the offering amounted to approximately SEK 39 million [8]. Strategic Expansion - Alvotech aims to expand its R&D capabilities, having recently acquired Xbrane Biopharma AB's R&D operations in Sweden, which will enhance its scientific and innovation capabilities [4]. - The integration of Xbrane's workforce is expected to strengthen Alvotech's presence in the Swedish life-science sector and support its growth trajectory [4]. Market Positioning - The listing on Nasdaq Stockholm is anticipated to improve Alvotech's recognition in Nordic and European markets, attracting a broader base of institutional and retail investors [5]. - There is strong investor demand for opportunities in European biotech, biopharma, and biosimilar stocks among Nordic and international institutional investors [5]. Trading Information - Trading of the SDRs on Nasdaq Stockholm is set to commence on May 19, 2025, under the ticker symbol "ALVO SDB" [8]. - A free conversion period for existing shareholders to convert their shares into SDRs will be offered for one year from the first trading day [7].

Core Insights - AEON Biopharma is advancing its biosimilar development program for ABP-450, aiming for FDA approval under the 351(k) regulatory pathway, which could cover all current and future indications of BOTOX [2][5] - The global therapeutic toxin market is estimated to be at least $3.3 billion, predominantly controlled by a single toxin, indicating significant market potential for AEON's ABP-450 [2][5] - The company reported cash and cash equivalents of $10.4 million as of March 31, 2025, which is expected to fund operations through the fourth quarter of 2025 [6] Recent Developments - AEON is conducting primary analytical studies in preparation for a potential Biosimilar Biological Product Development (BPD) Type 2a meeting with the FDA in the second half of 2025 [4][5] - Rob Bancroft has been appointed as President and CEO, bringing over 25 years of experience in the life sciences industry [4][5] - The company has received an extension until August 3, 2026, to regain compliance with NYSE American listing standards [6] Financial Performance - For the first quarter ended March 31, 2025, AEON reported a net income of $9.1 million, a significant improvement compared to a net loss of $118 million in the same period of 2024 [14][15] - Operating expenses decreased to $4.0 million from $10.4 million year-over-year, reflecting a reduction in selling, general, and administrative costs [15] - The total assets of the company increased to $13.8 million as of March 31, 2025, compared to $3.1 million at the end of 2024 [13]