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].

Core Insights - Teva Pharmaceuticals and Alvotech announced FDA approval for SELARSDI™ (ustekinumab-aekn) as interchangeable with Stelara® (ustekinumab), effective April 30, 2025, for various conditions including psoriatic arthritis and Crohn's disease [1][7][8] Company Developments - The approval of SELARSDI is seen as a significant advancement for patient access to affordable treatment options, aligning with Teva's strategy to lead in the biosimilars market [2][4] - Teva has launched two biosimilars, SELARSDI and EPYSQLI, and has a robust pipeline of additional biosimilars expected to launch in the coming years [2][4] - Alvotech is expanding its portfolio with two approved biosimilars in the U.S. and three additional biosimilar candidates under FDA review, indicating a strong growth trajectory [2][6] Product Information - SELARSDI is available in multiple presentations, including 45 mg/0.5 mL and 90 mg/mL for subcutaneous injection, and 130 mg/26 mL for intravenous infusion [2][7] - The biosimilar targets the p40 protein, crucial for treating immune-mediated diseases, and is produced using the same cell line and process as Stelara® [3][7] Strategic Partnerships - Teva and Alvotech have a strategic partnership for the exclusive commercialization of biosimilars, which has been extended to include additional products and presentations [4][5] - The partnership allows Teva to leverage its extensive sales and marketing infrastructure while Alvotech manages development and manufacturing [4][5] Market Context - The approval of SELARSDI and other biosimilars is part of a broader trend towards increasing access to biologic treatments, which is essential for lowering healthcare costs [2][4] - The FDA's approval of SELARSDI as interchangeable with Stelara® is expected to enhance competition in the biologics market, benefiting patients and healthcare providers [2][4]

Core Viewpoint - Amgen reported strong first-quarter 2025 results, exceeding earnings and revenue estimates, driven by robust product sales despite rising operating costs [1][20][21]. Financial Performance - Adjusted earnings per share were $4.90, surpassing the Zacks Consensus Estimate of $4.16, marking a 24% year-over-year increase [1]. - Total revenues reached $8.1 billion, exceeding the Zacks Consensus Estimate of $7.95 billion, reflecting a 9% year-over-year growth [1]. Product Revenue Breakdown - Total product revenues increased by 11% year-over-year to $7.87 billion, with volume growth of 14% partially offset by price declines [2]. - Prolia generated $1.1 billion in revenue, up 10% year-over-year, beating estimates [3]. - Evenity sales rose 29% year-over-year to $442 million, exceeding expectations [4]. - Repatha revenues increased by 27% year-over-year to $656 million, driven by a 41% rise in volumes [5]. - Xgeva delivered revenues of $566 million, up 1% year-over-year, beating estimates despite currency headwinds [6]. - Kyprolis sales declined 14% year-over-year to $324 million due to competitive pressures [7]. - Otezla sales were $437 million, up 11% year-over-year, beating estimates [9]. - Enbrel revenues fell 10% year-over-year to $510 million due to lower prices [10]. - Tezspire recorded sales of $285 million, up 65% year-over-year, exceeding expectations [11]. - New biosimilars, Wezlana and Pavblu, generated $150 million and $99 million in sales, respectively [12]. Cost and Margin Analysis - Adjusted operating margin increased by 2.5 percentage points to 45.7% [15]. - Adjusted operating expenses rose by 4% to $4.55 billion, with R&D expenses increasing by 11% [15]. Guidance and Future Outlook - Amgen reaffirmed its 2025 guidance, expecting total revenues between $34.3 billion and $35.7 billion and adjusted earnings per share between $20.00 and $21.20 [16]. - The company is developing MariTide, a new obesity treatment, with ongoing phase III studies [17][18][19]. Market Performance - Amgen's stock has risen 9.4% year-to-date, outperforming the industry, which has seen a 1.2% decline [21].

Financial Data and Key Metrics Changes - In Q1 2025, total revenues reached $695 million, reflecting a 5% growth year-over-year [4][28] - Adjusted EBITDA for the quarter was $170 million, which is a 12% increase compared to the previous year [4][30] - Adjusted EPS grew by 50%, reaching $0.21, driven by higher adjusted EBITDA and lower interest expenses [30] Business Line Data and Key Metrics Changes - Affordable Medicines segment generated $415 million in revenue, up 6%, with new product launches contributing $41 million [29] - Specialty segment revenue was $108 million, a 3% increase, primarily driven by the performance of Crexon and Unitroid [29] - AvKARE revenues were $172 million, growing 6%, with strong growth in the government channel [29] Market Data and Key Metrics Changes - The specialty segment's market share for Crexon has surpassed 1% and is projected to exceed 3% by the end of the year [7] - Trexon has achieved approximately 60% coverage of US lives, doubling from 30% in February [8] - The healthcare segment is expected to reach over $900 million in revenue by 2027 [15] Company Strategy and Development Direction - The company aims to be a leader in affordable medicines, focusing on innovation, quality, and operational excellence [5][16] - Amneal is expanding its specialty branded portfolio and anticipates launching a DHE auto injector later this year [9][21] - The strategic partnership with MedCera in the GLP-1 space is expected to drive long-term growth through new manufacturing facilities [10][22] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving peak sales of $300 to $500 million for Trexon and highlighted the strong market uptake of Crexon [9][27] - The company is well-positioned to address drug shortages and enhance patient access through its robust manufacturing capabilities [18][19] - Management affirmed full-year 2025 expectations, projecting total net revenue between $3 billion and $3.1 billion, reflecting 7% to 11% growth [33] Other Important Information - The company has a diverse array of growth drivers, including biosimilars, injectables, and specialty products [15][26] - Amneal has filed regulatory applications for five additional biosimilars this year, with a goal of having six biosimilars on the market by 2027 [14][25] Q&A Session Summary Question: What is the expected top-line contribution from biosimilars? - Management expects a total contribution of around $105 to $160 million from biosimilars, with Alimpsus projected to contribute between $90 to $100 million [40][41] Question: When will vertical integration for biosimilars occur? - Vertical integration is expected to be executed by the end of this year or early next year, with a focus on establishing a significant presence in the biosimilars market [41][42] Question: What is the focus between complex products and drug shortages in injectables? - The company is focusing equally on both complex products and addressing drug shortages, with a robust pipeline of injectable products [45][46]

REYKJAVIK, Iceland, May 02, 2025 (GLOBE NEWSWIRE) -- Alvotech (NASDAQ: ALVO), a global biotech company specialized in the development and manufacture of biosimilar medicines for patients worldwide, announced today that it will release financial results for the first quarter ended March 31, 2025, after U.S. markets close on Wednesday, May 7, 2025. Alvotech will also conduct a conference call with analysts to present the financial results and recent business highlights on Thursday, May 8, 2025, at 8:00 am EDT ...

Financial Data and Key Metrics Changes - The company reported total revenue of $65.5 billion for the first quarter of 2025, with adjusted earnings per share (EPS) growing to $6.74, leading to an increase in full-year EPS guidance to at least $29.6 [9][32][36] - Net after-tax special item charges amounted to $229 million, or $0.84 per share, which included a charge of $163 million related to a strategic optimization program [6][10] Business Line Data and Key Metrics Changes - EverNorth's revenues grew to $53.7 billion, with pretax adjusted earnings increasing by 5% to $1.4 billion [32] - Specialty and Care Services within EverNorth saw a revenue increase of 19% to $23.9 billion, while pharmacy benefit services reported a 14% revenue growth [33][24] - Cigna Healthcare's revenues were $14.5 billion, with pretax adjusted earnings of $1.3 billion and a medical care ratio (MCR) of 82.2% [34] Market Data and Key Metrics Changes - The company noted strong demand for strategic partners in healthcare, driven by the unsustainable trajectory of U.S. healthcare expenditures, which exceed $4.5 trillion annually [11] - The specialty pharmacy market is experiencing attractive growth rates due to new drug introductions and increased adoption of biosimilars [22] Company Strategy and Development Direction - The company is focused on building a more sustainable healthcare model, addressing key areas such as access, support, value, accountability, and transparency [12][14] - Strategic acquisitions, partnerships, and divestitures are part of the company's ongoing portfolio management, with the recent sale of its Medicare business as a notable example [12] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the company's ability to deliver 10% to 14% compounded EPS growth over the strategic horizon, despite a dynamic and challenging environment [14][15] - The company anticipates elevated medical cost trends in 2025 but remains optimistic about its action plans to improve margins and overall performance [35] Other Important Information - The company has repurchased 8.2 million shares for approximately $2.6 billion, reflecting a disciplined capital management strategy [39] - The company is committed to enhancing customer experience and transparency, with positive stakeholder feedback on recent initiatives [25][24] Q&A Session Summary Question: Weight loss and GLP-1 pricing opportunities - Management discussed the comprehensive approach to GLP-1 programs and the potential for improved pricing as net pricing decreases in this class, with over 50% of employers providing coverage for weight management [42][48] Question: Economic environment impact on client discussions - Management noted that affordability remains a key focus for employers, with strong retention rates in the Express Scripts business and continued interest in personalized solutions [56][58] Question: Stop loss business performance and cost trends - Management confirmed that the stop loss margin improvement plan is on track, with elevated trends in specialty and behavioral categories observed in the first quarter [63][70] Question: Arkansas legislation and potential conflicts of interest - Management opposed the Arkansas bill, emphasizing the importance of maintaining choice and transparency in the marketplace [75][76] Question: Capital deployment and M&A strategy - Management reiterated a consistent capital deployment strategy focused on supporting business growth, with a priority on bolt-on acquisitions [84][88]

Core Insights - Sandoz has signed a global collaboration agreement with Shanghai Henlius Biotech to commercialize a biosimilar of ipilimumab, with a total consideration of up to USD 301 million, including an upfront payment of USD 31 million, targeting net reference-medicine sales of USD 2.5 billion [2][3][7] Company Overview - Sandoz is a global leader in generic and biosimilar medicines, with a strategic ambition to occupy the leading position in the US biosimilars market, having recently moved up to third position [5][9] - The company has a robust biosimilars pipeline comprising 28 molecules and around 450 generic pipeline medicines, supporting its goal of sustainable long-term growth [5][9] - In 2024, Sandoz recorded net sales of USD 10.4 billion [9] Collaboration Details - Under the agreement, Sandoz has exclusive commercial rights for the biosimilar of ipilimumab in Australia, Canada, Europe, Japan, and the US, with the core sequence patent for ipilimumab having expired in March 2025 in the US and set to expire no later than February 2026 in the EU [3][4] - Henlius is developing its own proposed biosimilar of ipilimumab in an integrated Phase I/III trial targeting 656 patients [4] Market Potential - The combination therapy of ipilimumab and nivolumab is used in 95% of eligible patients, indicating a significant market opportunity for Sandoz's biosimilar [7] - The agreement aims to address considerable unmet medical needs and increase worldwide access to cancer treatments, reinforcing Sandoz's commitment to expanding patient access and driving sustainable savings for healthcare systems [7]

Investment Rating - The report assigns an "In-Line" investment rating for the biopharma industry in North America [7] Core Insights - The latest weekly Total Prescription (TRx) year-over-year (YoY) growth for the week ending April 11, 2025, was +2.7%, a decrease from +3.5% the previous week, but consistent with the +2.7% growth over the past 12 weeks [1][2] - The report highlights the launch performance of new drugs, including BMY's Cobenfy for schizophrenia and VRTX's Journavx for acute pain, with specific TRx targets needed to meet consensus sales estimates [3][4] Summary by Sections Market Overview - The US total market weekly TRx YoY change was +2.7% compared to +2.3% a year ago, with a rolling 4-week TRx YoY also at +2.7% [2] - Extended unit (EUTRx) weekly YoY growth was +1.4%, indicating a slower growth rate compared to TRx YoY [2] Drug Launch Analysis - BMY's Cobenfy, approved for schizophrenia, recorded approximately 1,660 scripts for the week, up from 1,580 the previous week, with a target of 105K TRx needed to meet 2025 consensus estimates [3] - VRTX's Journavx, approved for acute pain, had around 2,950 scripts for the week, with an estimated average script size of 35-37 pills, indicating a need for approximately 229K scripts for a 14-day duration to achieve $87 million in sales [4] Prescription Trends - The report includes a detailed analysis of prescription trends for major pharmaceuticals, highlighting significant YoY changes for key products such as Humira, Rinvoq, and Skyrizi [19][21] - The GLP-1 franchise, particularly Mounjaro and Zepbound, showed notable growth, with Mounjaro experiencing a 69% YoY increase [21] Seasonal Vaccine Tracking - The report tracks seasonal respiratory vaccines, noting that RSV vaccine volumes are approximately 65% below last year's levels, while COVID vaccine volumes are also down year-over-year [10]

Core Insights - Abbott's diversified business portfolio is positioned to drive momentum in 2025 despite foreign exchange challenges [1] - The stock currently holds a Zacks Rank 3 (Hold) [1] Factors Driving Abbott Shares - Abbott's Established Pharmaceuticals Division (EPD) saw an 8% organic sales increase in Q1 2025, leveraging its presence in emerging markets [2] - The company has secured rights to 15 biosimilar products and recently agreed to commercialize four additional biosimilars across various regions, enhancing its position in the branded generic pharmaceutical market [2] Diagnostics Business Expansion - Abbott's Diagnostics business accounted for 20% of total revenues in Q1 2025, with a 6.5% growth in Core Laboratory Diagnostics (excluding China) [3] Diabetes Care Growth - The FreeStyle Libre continuous glucose monitoring system has achieved global leadership, with sales in Diabetes Care growing 21.6% to over $1.7 billion in Q1 2025 [4][5] Stock Performance - Year-to-date, Abbott shares have gained 17.7%, outperforming the industry's 1.7% improvement, driven by expansion in high-growth areas and new product launches [6] Concerns for Abbott - Foreign exchange impacts were unfavorable, contributing to a 2.8% decline in sales year-over-year in Q1 2025 [7] - Rising raw material and freight costs, along with a challenging macroeconomic environment, may affect Abbott's business in the coming months [8] - Selling, general, and administrative expenses increased by 3.4% in Q1 2025 [9]

Financial Performance & Outlook - Total revenues reached $492 million, exceeding the latest guidance, compared to $93 million in 2023, a 427% increase[25,59] - Product revenues were $273 million, surpassing $49 million in 2023, a 462% increase[25,59] - Adjusted EBITDA was $108 million, a significant turnaround from a loss of $291 million in 2023[25,59] - The company anticipates revenues between $570 million and $670 million in 2025, with product revenue contributing $340 million to $410 million and milestone revenues between $230 million and $260 million[67] - The company projects an adjusted EBITDA between $180 million and $260 million in 2025[67] - Alvotech targets approximately $1.5 billion in revenue by 2028[70,77] - Alvotech targets an EBITDA margin of 40-45% by 2028[73,77] Commercial & R&D Updates - SIMLANDI units shipped to the US across both branded and private label channels in 2024 reached 1.3 million, with 60% of those units shipped in Q4 2024[35] - The company has biosimilar approval in 63 markets and has launched in 29 markets[37] - By the end of 2025, investments will enable a total annual capacity of 15 million finished units[42]