Core Viewpoint - Sandoz has launched WYOST® and Jubbonti®, the first and only interchangeable FDA-approved denosumab biosimilars in the US, aimed at improving access to treatment for osteoporosis and cancer-related skeletal events [2][7]. Company Overview - Sandoz is a global leader in generic and biosimilar medicines, with a growth strategy focused on pioneering access for patients. The company recorded net sales of USD 10.4 billion in 2024 and has a portfolio of approximately 1,300 products [21]. Product Launch Details - WYOST® and Jubbonti® are approved for all indications of the reference medicines XGEVA® and Prolia®, respectively, and are integral to Sandoz's growth strategy in the biosimilar market [2][3]. - The products are designed to provide high-quality, cost-effective treatment options, enhancing patient access and affordability in the US [3][5]. Patient Impact - The introduction of these biosimilars is expected to significantly improve treatment access for over 10 million US adults aged 50 and older living with osteoporosis, as well as for approximately 330,000 individuals with bone metastases [5][6]. - Sandoz is providing comprehensive support resources for patients prescribed these medications, including reimbursement and financial assistance [4]. Regulatory Approval - Both WYOST® and Jubbonti® have been approved as interchangeable with their reference medicines, ensuring they have the same dosage form, route of administration, and dosing regimen [3][6].

Core Viewpoint - Amgen reported strong financial results for Q1 2025, with total revenues increasing by 9% year-over-year to $8.1 billion, driven by robust product sales and successful new product launches [2][5][22]. Financial Performance - Total revenues for Q1 2025 were $8.1 billion, a 9% increase compared to Q1 2024 [5]. - Product sales grew by 11%, primarily due to a 14% increase in volume, although this was partially offset by a 6% decrease in net selling price [5]. - GAAP earnings per share (EPS) were $3.20, a significant recovery from a loss of $0.21 in Q1 2024, influenced by an unrealized gain on equity investments [5]. - Non-GAAP EPS increased by 24% from $3.96 to $4.90, reflecting higher revenues despite increased operating expenses [5][18]. - Free cash flow for Q1 2025 was $1.0 billion, up from $0.5 billion in Q1 2024, attributed to improved business performance [22]. Product Sales Performance - Repatha® sales rose by 27% year-over-year to $656 million, driven by a 41% increase in volume [6]. - TEPEZZA® sales decreased by 10% year-over-year to $381 million, primarily due to lower volume and inventory levels [4]. - Fourteen products achieved double-digit sales growth, including Repatha®, BLINCYTO®, TEZSPIRE®, and EVENITY® [5]. - IMDELLTRA® generated $81 million in sales during its launch quarter, with positive Phase 3 trial results [5]. Operating Expenses and Margins - Total operating expenses increased by 8% year-over-year, with cost of sales as a percentage of product sales decreasing by 7.3 percentage points [18]. - GAAP operating income rose from $1.0 billion to $1.2 billion, with an operating margin increase of 1.1 percentage points to 15.0% [5][18]. - Non-GAAP operating income increased from $3.1 billion to $3.6 billion, with a non-GAAP operating margin of 45.7%, up 2.5 percentage points [5][18]. Guidance for 2025 - The company expects total revenues for 2025 to be in the range of $34.3 billion to $35.7 billion [23]. - GAAP EPS is projected to be between $12.21 and $13.46, while non-GAAP EPS is expected to range from $20.00 to $21.20 [23]. - Capital expenditures are anticipated to be approximately $2.3 billion for the year [23].