Core Viewpoint - Fosun Pharma's subsidiary Shanghai Fuhong Hanlin Biotech has had its drug registration application for the biosimilar HLX14 accepted by the National Medical Products Administration of China, targeting all indications approved for the reference drug Prolia in mainland China [1] Group 1 - The drug HLX14 is a biosimilar to Prolia, which has already been approved for marketing in the US, EU, and UK [1] - The application for HLX14 covers all indications that Prolia has been approved for in China, excluding Hong Kong, Macau, and Taiwan [1] - Two products under HLX14, BILDYOS and BILPREVDA, have received approval in the aforementioned regions, aligning with the indications of their reference products Prolia and XGEVA [1]

Core Viewpoint - Alvotech has received approval from the European Commission for AVT03 as a biosimilar to Prolia® and Xgeva®, which is expected to enhance access to treatments for osteoporosis and cancer-related skeletal issues in Europe [1][2][4]. Company Summary - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a leader in the biosimilar market by providing high-quality, cost-effective products [11]. - The approval of AVT03 reflects the company's strong capabilities in delivering biosimilars at scale and its commitment to affordable healthcare solutions [4][5]. Product Details - AVT03 is approved in two forms: as a 60 mg/mL single-use pre-filled syringe for osteoporosis treatment and as a 70 mg/mL single-use vial for preventing skeletal-related events in cancer patients [3][9]. - The European denosumab market is valued at approximately US$1.2 billion, indicating significant commercial potential for AVT03 [2]. Clinical Evidence - The approval was based on comprehensive evidence, including pharmacokinetic and pharmacodynamic data, as well as results from clinical studies demonstrating equivalent efficacy and safety compared to the reference products [8]. Market Strategy - AVT03 will be marketed in Europe through partnerships with STADA and Dr. Reddy's, with each partner holding semi-exclusive rights in various regions [7]. - STADA will market AVT03 under the names Kefdensis® and Zvogra®, while Dr. Reddy's will use the names Acvybra® and Xbonzy® [7]. Economic Impact - Osteoporosis-related disabilities in Europe present a significant economic burden, with estimated costs of €57 billion in 2019 due to fragility fractures [6]. - The introduction of biosimilars like AVT03 is expected to support sustainable healthcare budgets by providing cost-effective treatment options [7].

This presentation contains forward-looking statements that are based on the current expectations and beliefs of Amgen. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including any statements on the outcome, benefits and synergies of collaborations, or potential collaborations, with any other company (including BeOne Medicines Ltd. or Kyowa Kirin Co., Ltd.), the performance of Otezla® (apremilast), our acquisitions of ChemoCentryx, In ...

Financial Performance - Revenues increased by 9% YoY in Q2 2025, reaching $9.179 billion, with product sales contributing $8.771 billion[9, 105] - Non-GAAP EPS grew by 21% YoY in Q2 2025, reaching $6.02[9, 105] - The company invested $1.7 billion in research and development in Q2 2025, an increase of 18% YoY[9] - Free cash flow was $1.9 billion in Q2 2025, compared to $2.2 billion in Q2 2024[107] Product Sales Highlights - Fifteen products achieved double-digit sales growth, including Repatha, EVENITY, IMDELLTRA, BLINCYTO, TEZSPIRE, UPLIZNA, and TAVNEOS[9, 17] - Repatha sales increased by 31% YoY to $696 million, driven by a 36% increase in volume[12, 23] - EVENITY sales increased by 32% YoY to $518 million, primarily driven by volume growth[12, 23] - UPLIZNA sales increased by 91% YoY to $176 million, driven by 79% volume growth[12, 27] - TEZSPIRE sales increased by 46% YoY to $342 million, driven by volume growth[12, 32] - IMDELLTRA generated $134 million in sales, with a 65% quarter-over-quarter increase[12, 37] Pipeline Development - MariTide: Phase 3 studies are enrolling for obesity and overweight, with or without Type 2 diabetes mellitus, and for adults living with heart failure with preserved or mildly reduced ejection fraction and obesity[42] - UPLIZNA: FDA review of Phase 3 data in generalized myasthenia gravis is ongoing, with a PDUFA date of December 14, 2025[46] - TEZSPIRE: FDA review of Phase 3 data in chronic rhinosinusitis with nasal polyps is ongoing, with a PDUFA date of October 19, 2025[59] - IMDELLTRA: Reduced the risk of death by 40% and significantly extended median OS by more than five months compared to SOC chemotherapy in patients with SCLC who progressed on or after one line of platinum-based chemotherapy[71]

Q1 2025 Financial Performance - Total revenue increased by 9% year-over-year, reaching $8.149 billion[97] - Product sales increased by 11% year-over-year, totaling $7.873 billion[97] - Non-GAAP EPS increased by 24% year-over-year, reaching $4.90[97] - Research and development investment increased by 12% year-over-year, reaching $1.5 billion[9] - Free cash flow was $980 million in Q1 2025, compared to $459 million in Q1 2024[117] Product Performance Highlights - Repatha sales increased by 27% year-over-year, reaching $656 million, driven by 41% volume growth[12, 22] - EVENITY sales increased by 29% year-over-year, reaching $442 million, driven by volume growth[12, 22] - Prolia sales increased by 10% year-over-year, reaching $1.099 billion, driven by 13% volume growth[12, 22] - TEZSPIRE sales increased by 65% year-over-year, reaching $285 million, driven by volume growth[12, 32] - BLINCYTO sales increased by 52% year-over-year, reaching $370 million, primarily driven by volume growth[12, 37] - IMDELLTRA generated $81 million in sales in Q1 2025[12, 17, 37] Pipeline and Regulatory Updates - FDA approved UPLIZNA for the treatment of IgG4-RD in adult patients[9, 51] - Positive Phase 3 data from IMDELLTRA, UPLIZNA, and rocatinlimab[9] - Initiated multiple Phase 3 trials of MariTide and TEZSPIRE[9] - The company expects 2025 revenue to be in the range of $34.3 billion to $35.7 billion[101]