Biosimilars

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Sandoz further asserts leadership in biosimilars, breaking ground on new Slovenia facility to expand European biosimilar hub and global market reach
Globenewswire· 2025-07-01 12:56
Core Viewpoint - Sandoz has initiated the construction of a new biosimilars production center in Brnik, Slovenia, as part of a strategic plan to capitalize on a significant market opportunity in the biosimilars sector, with an expected value of USD 222 billion over the next decade [2][3][7]. Investment and Expansion - The new production facility represents a USD 440 million investment, contributing to a total planned investment in Slovenia exceeding USD 1.1 billion by 2029 [2][7]. - This investment is part of ongoing efforts to enhance in-house manufacturing capabilities and establish a fully integrated European biosimilar hub [3][7]. Market Opportunity - The biosimilars market is projected to grow significantly due to patent expiries, with Sandoz aiming to capture a substantial share of this opportunity [3][7]. - Sandoz currently has 11 marketed biosimilars and an industry-leading pipeline of 28 molecules, positioning the company to meet increasing patient demand [4]. Strategic Importance of Slovenia - Slovenia is recognized for its skilled workforce in natural sciences and engineering, central location, cost-competitive production, and strong ties to academia and research, making it a strategic site for Sandoz's manufacturing operations [4][5]. Product Focus - The new facility will specialize in the production of injectable biosimilars, including preparation, filling, assembly, and packaging, along with quality control laboratories [4].
Will CVS Health's Formulary Move Boost Its Weight Management Program? (Revised)
ZACKS· 2025-06-30 15:31
Key Takeaways CVS adds Wegovy to Caremark formularies while removing Zepbound to balance costs and access. The move supports CVS' Weight Management program, pairing GLP-1 with lifestyle coaching. CVS shares are up 48.8% YTD, trading at a forward P/S of 0.21X versus the industry average of 0.40X.For CVS Health (CVS) , the key to building customer trust is to enhance access to life-changing medications and also make them affordable. Beginning July 1, the company’s Pharmacy Benefit Manager (“PBM”), CVS Carem ...
Amneal Pharmaceuticals (AMRX) FY Conference Transcript
2025-06-10 15:40
Amneal Pharmaceuticals (AMRX) FY Conference June 10, 2025 10:40 AM ET Speaker0 Okay. Great. Well, thank you everyone for joining us today. My name is Matt Delatorre, and I'm the generics pharma analyst here at GS. And we're we're very pleased to have Amneal Pharmaceuticals with us for this session with Sharag Patel, cofounder and co CEO, and Tassos Konidaris, the chief financial officer. Great. So maybe maybe just to get started, you know, how about just level set us on where Amneal is headed from kind of a ...
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].
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]
Tevogen to Update on Robust Portfolio Assets, Business Expansion, Partnerships, Limited Tradable Float, High Insider Ownership and Strong Investor Confidence Ahead of June 23 Annual Meeting
Globenewswire· 2025-05-22 17:21
Core Insights - Tevogen Bio Holdings Inc. is preparing to provide updates to stockholders ahead of its Annual Meeting scheduled for June 23, 2025, focusing on its innovative business model and strategic growth initiatives [1] Group 1: Portfolio Assets - The company will update investors on its portfolio assets, which include Tevogen Bio Oncology, Tevogen Bio Specialty Care, and Tevogen.AI, valued at over $10 billion as of October 2024 [2] Group 2: Corporate Highlights - Tevogen will detail two strategic initiatives: Tevogen.AI and Tevogen Generics & Biosimilars, alongside plans to expand its operational footprint with an upgraded headquarters [3] Group 3: Financial Market Dynamics - Management is monitoring stock dynamics, noting the impact of a limited tradable float and the growing institutional ownership, which reflects strong investor confidence and long-term holding patterns [4]
Alvotech Announces the Outcome of the Offering in Connection with the Company's Listing on Nasdaq Stockholm
GlobeNewswire News Room· 2025-05-16 17:52
Core Viewpoint - Alvotech, a global biotech company focused on biosimilar medicines, successfully completed an oversubscribed offering of Swedish Depository Receipts (SDRs) in connection with its listing on Nasdaq Stockholm, which is expected to enhance its market presence and access to capital [2][5][8]. Offering Details - The offering attracted strong interest, resulting in over 3,000 new shareholders and was multiple times oversubscribed [2][8]. - The final price per SDR was set at SEK 87.51, reflecting a 10% discount from the volume-weighted average price of the ordinary shares during the application period [8]. - The gross proceeds from the offering amounted to approximately SEK 39 million [8]. Strategic Expansion - Alvotech aims to expand its R&D capabilities, having recently acquired Xbrane Biopharma AB's R&D operations in Sweden, which will enhance its scientific and innovation capabilities [4]. - The integration of Xbrane's workforce is expected to strengthen Alvotech's presence in the Swedish life-science sector and support its growth trajectory [4]. Market Positioning - The listing on Nasdaq Stockholm is anticipated to improve Alvotech's recognition in Nordic and European markets, attracting a broader base of institutional and retail investors [5]. - There is strong investor demand for opportunities in European biotech, biopharma, and biosimilar stocks among Nordic and international institutional investors [5]. Trading Information - Trading of the SDRs on Nasdaq Stockholm is set to commence on May 19, 2025, under the ticker symbol "ALVO SDB" [8]. - A free conversion period for existing shareholders to convert their shares into SDRs will be offered for one year from the first trading day [7].
Cencora (COR) 2025 Conference Transcript
2025-05-13 19:20
Summary of Cencora (COR) 2025 Conference Call Company Overview - **Company**: Cencora (COR) - **Date of Conference**: May 13, 2025 - **Key Speakers**: Bob Mach (CEO), Jim Cleary (EVP and CFO), Bennett Murphy (SVP and Head of IR and Treasury) Industry Insights - **Industry**: Specialty Pharmaceuticals and Healthcare Distribution Key Points and Arguments Business Model and Pricing - The company has evolved its business model over the past decade, moving from a reliance on generics to a more diversified approach that includes fixed fee contracts and specialty medications [2][10] - The impact of potential changes to drug pricing, such as the MFN executive order, is uncertain, but the company believes it will not harm community providers or patient access [4][5][9] - Cencora has been proactive in Washington, advocating for providers and patient access to pharmaceuticals, which positions them favorably in discussions about pricing changes [6][7][8] Financial Performance - Cencora has experienced strong earnings growth, with a 23% increase in US operating income in the most recent quarter [18] - The company has outperformed its guidance multiple times this fiscal year, driven by strong utilization trends and sales of specialty products [15][17] - The company expects continued strong performance in 2025, with no significant changes anticipated compared to 2024 [16][20] Specialty and Health Systems - Cencora is well-positioned in the specialty market, particularly within health systems, which are increasingly setting up their own pharmacies [21][22] - The company provides consulting services to health systems to help them expand their pharmacy services, including specialty and infusion pharmacies [27][28] Generics and Inventory Management - Cencora maintains disciplined inventory levels and focuses on strong product access for customers, particularly in the generics market [31][32][33] - The company is cautious about potential tariffs on pharmaceuticals but is not significantly altering its inventory strategy [29][30] Operating Expenses and Growth Strategy - The company emphasizes operating leverage, aiming for operating expenses to grow slower than gross profit [36][37] - Cencora is focused on productivity initiatives to enhance efficiency as it continues to grow [39] Market Opportunities - Cencora is targeting organic growth in oncology and retina specialties, with a focus on attracting smaller physician practices [41][42] - The company is optimistic about the adoption of biosimilars in the physician space, which is already strong [49][50] Capital Deployment - Cencora plans to maintain balanced capital deployment, with approximately $600 million allocated for capital expenditures this year, primarily for technology and infrastructure [52][53] - The company has a strategy for opportunistic share repurchases and aims to grow dividends at a sustainable rate [54][55] Future Outlook - The leadership team is excited about the growth potential in specialty pharmaceuticals, driven by innovation and technology [56][57] - The focus on customer centricity and active engagement with stakeholders is expected to sustain the company's momentum [58][59] Additional Important Insights - The company has a long-term partnership with physicians in oncology and retina, which enhances its competitive position [45][46] - Cencora's unique understanding of the pharmaceutical supply chain allows it to advocate effectively for its stakeholders [7][8] This summary captures the essential insights and strategic directions discussed during the conference call, highlighting Cencora's positioning within the specialty pharmaceuticals industry and its proactive approach to market challenges.
Organon & Co: Cost Takeout Catalysts, Initiate Strong Buy
Seeking Alpha· 2025-05-12 15:47
We initiate (NYSE: NYSE: OGN ) at Strong Buy w/ $26.4 PT. Organon & Co. is a diversified portfolio of Rx therapies anchored by global leadership in women's health and accelerating biosimilars. Our thesis is supported by a forecasted operational inflection , withMoretus Research delivers state-of-the-art, buy-side quality equity research for serious investors seeking clarity, conviction, and alpha. Focused on U.S. public markets, Moretus applies a structured, repeatable framework to identify companies with d ...