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]

Financial Data and Key Metrics Changes - In Q4 2024, revenues reached $731 million, growing 18% year-over-year, with adjusted EBITDA of $155 million, reflecting a 9% increase [42][45][49] - For the full year 2024, total revenues were $2.8 billion, a 17% increase from the previous year, and adjusted EBITDA was $627 million, up 12% [47][49] - Net leverage decreased to 3.9 times, down from 4.8 times at the end of 2023, and significantly reduced from 7.4 times at the end of 2019 [40][49] Business Line Data and Key Metrics Changes - The affordable medicine segment grew 21% in Q4 to $439 million, with full-year growth of 15% [42][47] - Specialty revenues increased 16% in Q4 to $121 million, driven by branded products, including $3 million from the newly launched Crexent [44][47] - The RevCare segment saw a 14% growth in Q4 to $170 million, with expectations for continued double-digit growth [22][45] Market Data and Key Metrics Changes - The specialty business is projected to grow to over $500 million by 2027, driven by Crexent and other branded products [10] - The global biosimilar market is expected to grow from $33 billion today to $75 billion by 2030, with significant opportunities due to expiring patents [18][19] Company Strategy and Development Direction - The company aims to enhance its long-term growth profile through strategic initiatives, including the launch of Crexent and expansion into the biosimilars market [8][11] - A collaboration with Medcera in the weight loss and obesity space is expected to drive innovation and growth, with plans to commercialize products in 20 emerging markets [12][13] - The company is focused on becoming vertically integrated in biosimilars and expanding its injectable portfolio [37][39] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving continued top and bottom-line growth in 2025, despite the anticipated loss of exclusivity for Rytary [41][50] - The company is optimistic about the early success of Crexent and its potential to become a leading therapy for Parkinson's disease [44][68] - Management highlighted the importance of maintaining a strong cash flow and reducing debt while investing in growth areas [52][54] Other Important Information - The company fulfilled over 162 million prescriptions annually in the U.S. and is the largest U.S. manufacturer of affordable medicines [24] - The company is targeting to become a top player in the U.S. injectables and biosimilars markets in the coming years [24] Q&A Session Summary Question: Can you elaborate on the launch of Crexent? - Management reported strong early adoption and positive patient testimonials, with formulary access currently at about 30% and expected to rise to 50% [60][65] Question: What are the expectations for GLP-1 launches by 2028? - Management indicated that the launches could include products like Trulicity and involve contract manufacturing, with a manageable CapEx of $100 to $150 million over three years [80] Question: Any updates on naloxone contracts? - Management noted that progress is being made with several states, aiming to provide about 2.5 million kits this year, increasing to 4 million by 2026 [92] Question: What is the long-term opportunity for Unithroid? - Management sees consistent growth potential for Unithroid, similar to Synthroid, as it provides stable therapy for patients [94] Question: What is the target for debt reduction in 2025? - Management aims to reduce net debt to EBITDA to around 3.6% to 3.7% in 2025, with a gross debt reduction target of $80 to $100 million [95][96]

Financial Data and Key Metrics Changes - In Q4 2024, revenues reached $731 million, an 18% increase year-over-year, with double-digit growth across all segments [42][46] - For the full year 2024, total revenues were $2.8 billion, a $400 million or 17% increase compared to the previous year, exceeding guidance [47][49] - Adjusted EBITDA for 2024 was $627 million, growing 12% year-over-year, and operating cash flow was $348 million [48][49] - Net leverage decreased to 3.9 times, down from 4.8 times at the end of 2023, achieving the target a year ahead of schedule [40][49] Business Line Data and Key Metrics Changes - The affordable medicine segment generated $1.7 billion in 2024, growing 15%, driven by new launches and a diversified portfolio [14][47] - Specialty business grew 14% in 2024, with a goal to exceed $500 million by 2027, supported by products like Crexent and Unithroid [10][11] - RevCare segment revenue grew 25% to $900 million, with expectations for continued double-digit growth [22][49] Market Data and Key Metrics Changes - The biosimilars segment generated $126 million in revenue in 2024, with plans for six commercial biosimilars by 2027 [17][18] - The global biosimilar market is projected to grow from $33 billion to $75 billion by 2030, presenting significant opportunities for the company [18][19] Company Strategy and Development Direction - The company aims to enhance its long-term growth profile through strategic initiatives like the launch of Crexent and collaboration with Medcera in the weight loss space [8][11] - Plans to build two new high-volume peptide manufacturing facilities to support the Medcera collaboration and expand capabilities in the weight loss market [12][30] - The focus remains on vertical integration and expanding the biosimilars portfolio, with a commitment to R&D and operational excellence [20][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving continued top and bottom-line growth in 2025, despite the anticipated loss of exclusivity for Rytary [41][50] - The company is optimistic about the early success of Crexent and its potential to become a leading therapy for Parkinson's disease [10][44] - Management highlighted the importance of maintaining a strong organic pipeline while considering strategic M&A opportunities [72][86] Other Important Information - The company is positioned as the largest US manufacturer of affordable medicines, fulfilling over 162 million prescriptions annually [24] - The strategic focus includes expanding into emerging markets and enhancing global access for products like Crexent [68] Q&A Session Summary Question: Can you elaborate on the launch of Crexent? - Management reported strong early adoption and positive patient testimonials, with formulary access currently at about 30% and expected to increase [60][65] Question: What are the thoughts on organic investments versus external business development? - The company is focused on a solid organic pipeline while also looking for strategic acquisitions to enhance its portfolio [72][86] Question: Any updates on naloxone contracts and Unithroid's long-term opportunity? - Naloxone contracts are progressing slowly, with expectations to provide 2.5 million kits this year [92] - Unithroid is expected to maintain a consistent growth profile similar to Synthroid [94] Question: What is the target for debt reduction in 2025? - The company aims to reduce net debt to EBITDA to around 3.6% to 3.7% in 2025, with a gross debt reduction target of $80 to $100 million [95][96]

Financial Data and Key Metrics Changes - In Q4 2024, revenues reached $731 million, growing 18% year-over-year, with double-digit growth across all segments [30] - Full year 2024 total revenues were $2.8 billion, up $400 million or 17% year-over-year, exceeding guidance [32] - Adjusted EBITDA for Q4 was $155 million, reflecting a 9% increase, while full year adjusted EBITDA was $327 million, growing 12% [31][32] - Net leverage decreased to 3.9 times compared to 4.8 times at the end of 2023, with a target to reduce it further [29][33] Business Line Data and Key Metrics Changes - The Affordable Medicines segment grew 21% in Q4 to $439 million, with new product launches contributing $54 million [30] - Specialty revenues increased 16% to $121 million, driven by branded products including Krexant [31] - The AvCare segment grew 14% to $170 million, reflecting strong performance across distribution and government channels [31] - Biosimilars generated $39 million in Q4, growing 49% year-over-year [30] Market Data and Key Metrics Changes - The specialty business is projected to exceed $500 million by 2027, driven by products like Krexant and upcoming launches [8] - The global weight loss market is expected to exceed $150 billion by 2030, presenting a significant growth opportunity for the company [11] - The biosimilars market is projected to grow from $33 billion today to $75 billion by 2030, with a significant opportunity for cost savings in the U.S. [15] Company Strategy and Development Direction - The company aims to enhance its long-term growth profile through strategic initiatives such as launching Krexant and expanding its biosimilars pipeline [6][10] - A collaboration with MedCera focuses on developing next-generation therapies, positioning the company as a preferred supplier in the U.S. and Europe [10][22] - The company is committed to becoming vertically integrated, leveraging its manufacturing and R&D capabilities to drive growth in biosimilars and specialty products [26][37] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in achieving continued top and bottom line growth in 2025, despite anticipated territory loss of exclusivity [29] - The company is focused on driving execution across development, manufacturing, and commercialization to support its diversified business [28] - Management highlighted the importance of maintaining a strong cash flow and reducing debt levels while investing in growth areas [37] Other Important Information - The company plans to launch 20 to 30 new products each year, with a focus on complex generics and injectables [24] - The first three biosimilars generated $126 million in revenue in 2024, with plans for additional filings and launches in the coming years [14][27] - The company is the largest U.S. manufacturer of affordable medicines, fulfilling over 162 million prescriptions annually [18] Q&A Session Summary Question: Can you elaborate on the launch of Krexant and its market dynamics? - Management reported strong initial adoption and positive patient testimonials, with market share reaching about 1% in four months, aiming for over 3% by year-end [7][41] Question: What is the current status of formulary access for Krexant? - The company is pleased with a 30% coverage rate and anticipates it to increase to around 50% this year, aiming to surpass Rytary's coverage [44] Question: How does the company plan to balance long-term investments with top-line growth? - The company has a solid organic pipeline and plans to allocate capital towards biosimilars and specialty portfolio additions while maintaining a focus on debt reduction [50][52] Question: What is the outlook for GLP-1 launches by 2028? - The company envisions a combination of U.S. and ex-U.S. products, including potential contract manufacturing opportunities [56] Question: Can you provide updates on naloxone contracts and Unithroid's long-term opportunity? - Naloxone contracts are progressing slowly, with expectations to provide 2.5 million kits this year, while Unithroid is expected to maintain a consistent growth profile [67] Question: What are the deleveraging targets for 2025? - The company aims to reduce net debt to EBITDA to approximately 3.6% to 3.7% in 2025, continuing its focus on debt reduction [70]