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RDY & ALVO Ink Collaboration Deal for Merck's Keytruda Biosimilar
ZACKS· 2025-06-05 16:31
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]
Alvotech (ALVO) 2025 Conference Transcript
2025-06-05 15:32
Summary of Alvotech (ALVO) Conference Call Company Overview - Alvotech is a leading pure play biosimilars company focused on providing access to low-cost biologic drugs globally, with a strong emphasis on high quality [3][4] - The company has established a significant presence in the biosimilars market over the past ten years, with a total addressable market for biologics estimated at $200 billion [4] Core Business Strategy - Alvotech employs a partnership approach, collaborating with strong local partners in various countries to enhance market reach [4][16] - The company has invested heavily in R&D and manufacturing capabilities, integrating both functions to streamline operations [14][15] - Alvotech has a multiproduct portfolio strategy, with a focus on biosimilars, which are projected to grow significantly as patents for biologics expire [7][10] Market Opportunity - Approximately 120 biologics are expected to lose patent protection in the next ten years, creating a substantial opportunity for biosimilar development [7] - The biosimilar market has been growing at around 20% over the last three years, particularly in immunology and oncology [11] Financial Performance and Projections - Alvotech reported revenues of approximately $275 million last year, with expectations to grow to between $600 million and $700 million this year [28] - EBITDA is projected to increase from $108 million to between $200 million and $280 million this year, indicating strong operating leverage [28] - By 2028, Alvotech aims to achieve revenues exceeding $1.5 billion, with an EBITDA margin of 40-45% [29][30] Product Pipeline and Launches - Alvotech has launched two biosimilars in the U.S. market: Humira (ABTO2) and Stelara (AVTO4) [19][20] - The company anticipates three new approvals and launches by the end of the year, with a total addressable market of around $5 billion [21] - Future launches include biosimilars for Entyvio, high-dose Eylea, and others, expected to contribute significantly to revenue targets [22][33] Strategic Partnerships - Alvotech has established 19 global partnerships, which provide steady cash flow and support R&D funding [16] - The company emphasizes deepening existing partnerships to leverage market opportunities effectively [42][43] Risk Management - Alvotech does not foresee significant impacts from U.S. tariffs due to favorable tariff rates and contract structures [25] - The company is confident in its ability to navigate patent discussions and maintain a competitive edge in the biosimilar market [37][41] Conclusion - Alvotech is positioned as a strong player in the biosimilars market with a robust growth strategy, significant market opportunities, and a comprehensive product pipeline [35]
Amneal Pharmaceuticals (AMRX) 2025 Conference Transcript
2025-06-05 14:20
Amneal Pharmaceuticals (AMRX) 2025 Conference June 05, 2025 09:20 AM ET Speaker0 To get an on time start. It's my pleasure. I am Jonas Schirleff from the Healthcare Investment Banking team here at Jefferies. Today we will be hearing from Chirag Entasos from the Amneal Pharmaceuticals team and I will hand it over to you. Thank you very much. Speaker1 Thank you. Thank you. Good morning everyone. Great to see you. Beautiful summer day and hopefully you guys get to go out and walk around and I think the Canadia ...
Alvotech and Dr. Reddy’s Enter into Collaboration to Co-Develop Biosimilar Candidate to Keytruda® (pembrolizumab)
Globenewswire· 2025-06-05 06:55
Core Viewpoint - Alvotech and Dr. Reddy's Laboratories have entered a collaboration to co-develop a biosimilar candidate to Keytruda® (pembrolizumab), which had worldwide sales of US$29.5 billion in 2024, aiming to enhance the availability of cost-effective biologic medications for cancer treatment globally [1][2][3][4]. Company Overview - Alvotech is a global biotech company focused on developing and manufacturing biosimilar medicines, with a goal to be a leader in the biosimilar space by providing high-quality, cost-effective products [7]. - Dr. Reddy's Laboratories is a global pharmaceutical company committed to providing access to affordable and innovative medicines, with a focus on various therapeutic areas including oncology [10][11]. Collaboration Details - The collaboration agreement stipulates that both companies will share responsibilities and costs in the development and manufacturing of the biosimilar candidate, with each party having the right to commercialize the product globally [2]. - This partnership is expected to leverage the strengths of both companies in biosimilars, accelerating the development process and expanding market reach [1][3][4]. Market Context - Keytruda® is a critical therapy in immuno-oncology, and the collaboration aims to enhance the capabilities of both companies in this therapeutic area [4]. - The biosimilars market is growing, and this collaboration positions both companies to capitalize on the increasing demand for affordable cancer treatments [3][4].
Alvotech has carried out a private placement of 7,500,000 SDRs and ordinary shares at a price of SEK 100.00 per SDR and ISK 1320.83 per ordinary share, raising gross proceeds of SEK 750 million
Globenewswire· 2025-06-04 23:55
Core Viewpoint - Alvotech has successfully completed a private placement of 7,500,000 shares, raising gross proceeds of SEK 750 million, with strong interest from institutional investors, particularly from Sweden and other international markets [2][4][5]. Group 1: Placement Details - The private placement included 5,833,500 Swedish Depository Receipts (SDRs) and 1,666,500 ordinary shares, priced at SEK 100.00 per SDR and ISK 1320.83 per ordinary share, reflecting current market conditions [3][5]. - The transaction was facilitated by DNB Carnegie and Citi as Joint Global Coordinators and Joint Bookrunners, with SEB and ACRO also participating as Joint Bookrunners [2][3][13]. - Settlement of the placement is expected around June 10, 2025, for both SDRs and ordinary shares [8]. Group 2: Use of Proceeds - The net proceeds from the placement will be allocated to upscale R&D efforts, particularly in Sweden, following the acquisition of Xbrane's R&D operations, and to capitalize on growth opportunities [5][7]. - The funds will also be used for general corporate purposes, enhancing the company's market position [5]. Group 3: Shareholder Base and Market Impact - The placement is expected to diversify and strengthen Alvotech's shareholder base, particularly among institutional investors in Sweden, and significantly increase the float of SDRs on Nasdaq Stockholm [7]. - The strong interest from institutional investors indicates the importance of the SDR listing on Nasdaq Stockholm for the company's growth strategy [4][7].
Alvotech intends to carry out a private placement of approximately 7.5 million SDRs and ordinary shares
Globenewswire· 2025-06-04 15:32
Core Viewpoint - Alvotech intends to conduct a private placement of approximately 7.5 million Swedish Depository Receipts (SDRs) and ordinary shares to strengthen its shareholder base and fund R&D activities [2][4]. Group 1: Placement Details - The placement will be executed through an accelerated bookbuilding procedure, with pricing and total number of SDRs and ordinary shares to be determined during this process [3][6]. - The completion of the bookbuilding and pricing is expected before trading starts on Nasdaq Stockholm at 09:00 CEST on June 5, 2025 [3]. - The company may adjust the timing of the bookbuilding and has the discretion to shorten, extend, or suspend the placement [3]. Group 2: Use of Proceeds - Net proceeds from the placement are intended to accelerate Alvotech's R&D activities, particularly following the acquisition of Xbrane's R&D operations [4]. - The funds will also be used for general corporate purposes, allowing Alvotech to expand its pipeline and capitalize on growth opportunities [4]. Group 3: Shareholder and Management Commitments - The company and its executive management have agreed not to sell or transfer additional SDRs or ordinary shares for 180 days post-placement settlement, subject to certain conditions [7][8]. - Major shareholders have also committed to not dispose of their holdings for 90 days following the placement [10]. Group 4: Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines, with two biosimilars already approved and a pipeline of nine candidates targeting various diseases [13]. - The company aims to be a global leader in the biosimilar market, leveraging strategic partnerships for market reach [13].
Alvotech Completes Acquisition of Xbrane R&D Organization and biosimilar candidate to Cimzia®
Globenewswire· 2025-06-04 11:45
Core Viewpoint - Alvotech has successfully completed the acquisition of Xbrane Biopharma's R&D organization and a biosimilar candidate to Cimzia®, enhancing its development capacity and presence in the Swedish life science sector [1][2]. Group 1: Transaction Details - The acquisition was announced on March 20, 2025, and approved on April 14, 2025, with a total purchase price of approximately SEK 275 million (US$28.9 million) [2]. - The payment structure includes a cash payment of approximately SEK 102.2 million, assumption of convertible debt of approximately SEK 152.75 million, and assumption of accounts payable related to the biosimilar candidate of approximately SEK 20 million [7]. Group 2: Company Overview - Alvotech is a biotech company focused on developing and manufacturing biosimilar medicines, aiming to be a global leader in the biosimilar space with a fully integrated approach and broad in-house capabilities [4]. - The company has two approved biosimilars, targeting Humira® (adalimumab) and Stelara® (ustekinumab), and a pipeline of nine disclosed biosimilar candidates for various diseases [4]. - Alvotech has established strategic commercial partnerships across multiple regions, including the United States, Europe, Japan, China, and parts of South America, Africa, and the Middle East [4].
Sandoz launches first and only interchangeable denosumab biosimilars in US, providing new affordable treatment options for over 10 million patients[1]
Globenewswire· 2025-06-02 05:00
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].
Abbott Benefits From Libre & Biosimilars Amid FX, Cost Headwinds
ZACKS· 2025-05-30 15:10
Core Insights - Abbott's diversified business portfolio is positioned for continued growth into 2025 despite foreign exchange challenges [1][7] - The company has seen significant growth in its Diagnostics and Diabetes Care segments, with a strong demand for routine diagnostics and continuous glucose monitoring systems [2][3][4] Business Performance - Abbott's Diagnostics business accounted for 20% of total revenues in Q1 2025, with a 6.5% growth in core laboratory diagnostics, excluding China [2] - The Diabetes Care segment reported sales exceeding $1.7 billion in Q1 2025, growing 21.6%, driven by the success of the FreeStyle Libre system [4] - Established Pharmaceuticals Division (EPD) sales increased 8% organically in Q1 2025, supported by a focus on biosimilars and a licensing model in emerging markets [5] Market Position - Year-to-date, Abbott's shares have gained 18.6%, outperforming the industry average of 5.2%, indicating strong market momentum [6] - Abbott's FreeStyle Libre has achieved global leadership in continuous glucose monitoring systems for both Type 1 and Type 2 diabetes users [3][4] Challenges - Foreign exchange fluctuations negatively impacted Abbott's sales by 2.8% year-over-year in Q1 2025, primarily due to a significant portion of revenues coming from international markets [7] - The company faces increased expenses related to raw materials and freight due to a challenging macroeconomic environment, which may affect future performance [8][9]
TEVA Stock Up Around 13% in a Month: Buy, Sell or Hold the Stock?
ZACKS· 2025-05-27 16:21
Core Viewpoint - Teva Pharmaceutical Industries Limited's stock has experienced a 12.9% increase over the past month, primarily following the announcement of its first-quarter 2025 results, which were mixed in nature [1][2]. Financial Performance - Teva's first-quarter results showed earnings that exceeded estimates but sales that fell short. The company slightly adjusted its sales guidance for 2025, lowering the upper end while increasing the lower end of its EPS range [2]. - The company anticipates U.S. tariffs to have an "immaterial impact" on profits, which are already included in its 2025 earnings outlook [3]. - Teva expects to achieve approximately $700 million in net cost savings by 2027, driven by operational efficiencies and growth in branded drugs [4]. Product Pipeline and Growth - Teva is experiencing growth in its branded drugs, particularly Austedo and Ajovy, with Ajovy sales increasing by 18% in 2024 and 26% in Q1 2025. Austedo is projected to generate over $2.5 billion in annual revenues by 2027 [6][7]. - The company launched Uzedy in May 2023, achieving sales of approximately $117 million in 2024, exceeding its target [8]. - Teva's pipeline includes promising products like olanzapine and duvakitug, with plans for a phase III program on duvakitug in late 2025 [9]. Generics and Biosimilars - Teva has successfully launched several high-value complex generics and biosimilars, contributing to a 15% growth in its U.S. generics/biosimilars business in 2024 [10][13]. - The company plans to launch seven biosimilars in the U.S. and four in Europe between 2025 and 2027, with several under review [12]. Legal and Settlement Developments - Teva has resolved its nationwide opioid litigation, agreeing to pay up to $4.25 billion over 13 years, which includes delivering its generic version of Narcan [15]. - The settlement has allowed the company to clear a significant legal hurdle, potentially stabilizing its financial outlook [25]. Valuation and Market Position - Teva's stock is currently trading at a price/earnings ratio of 6.51, which is lower than the industry average of 9.70, indicating an attractive valuation [19]. - Despite a 23% decline in stock value year-to-date, the company is positioned for potential long-term growth due to its new product launches and stable generics business [16][24].