Sanofi (SNY) and partner Regeneron (REGN) announced that the FDA has accepted their resubmitted supplemental biologics license application (sBLA) seeking approval of Dupixent for the treatment of chronic spontaneous urticaria (CSU).The sBLA seeks approval for CSU in people aged 12 years and older whose disease is not adequately controlled with existing therapies like H1 antihistamines. The FDA’s decision on the sBLA is expected on April 18, 2025.The FDA had issued a complete response letter (CRL) for the fi ...

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Deal Overview - On October 21, 2024, Sanofi announced exclusive negotiations with Clayton, Dubilier & Rice (CD&R) to transfer around 50% controlling stake in Opella, its consumer healthcare business unit focusing on over-the-counter medicines, vitamins, and supplements [1][2] - The deal values Opella at approximately €16 billion, implying 14 times the 2024 estimated EBITDA [2] Strategic Rationale - Sanofi aims to create a standalone leader in consumer healthcare while focusing on innovative medicines and vaccines [2] - The divestment aligns with Sanofi's 'Play to Win' strategy initiated in December 2019, which emphasizes enhancing growth and fostering innovation [5] - The company expects to achieve around €2.0 billion in cost savings from 2024 until the end of 2025, which will be reallocated to fund innovation [7] Company Performance - The Biopharma business contributed approximately 87.8% of FY23 total revenue, while Consumer Healthcare contributed about 12.2% [6] - Opella generated $5.6 billion in revenue during FY23 and operates in 100 countries with 13 manufacturing facilities [10] Market Position and Future Outlook - By retaining a significant stake in Opella, Sanofi can benefit from the consumer healthcare market while reallocating resources to high-growth areas like specialty care and vaccines [8] - The partnership with CD&R is expected to enhance Opella's operational efficiency and market competitiveness [8]

No investor can ignore a crushing bottom-line beat and raised profitability guidance. Investors traded on the latest news about global pharmaceutical company Sanofi (SNY 4.40%) Friday. Happily for existing shareholders, the news -- of its third-quarter results -- was encouraging, and the stock rose as the trading week came to a close. It climbed more than 4%, sharply contrasting the basically flat-lining S&P 500 index. Crushed bottom-line consensus One reason investors were impressed by Sanofi's latest fund ...

Financial Data and Key Metrics - Q3 2024 total sales reached EUR13.4 billion, a 16% increase at constant exchange rates (CER), with an estimated 11% growth excluding phasing impacts [3] - Dupixent sales approached EUR3.5 billion in Q3, driven by global volume growth across all indications and geographies [3] - Vaccines business grew 26%, benefiting from flu season phasing and strong contributions from Beyfortus [3] - Pharma launches saw a 67% increase in sales, driven by strong performance across eight recently launched medicines [4] - Business operating income increased by 19.9% in Q3, driven by higher gross profit and operating leverage [13] - Business EPS increased by 17.6% in Q3, with full-year 2024 guidance upgraded to at least low-single-digit growth [13][15] Business Line Performance - Dupixent achieved a milestone of improving the lives of over 1 million patients globally, with strong market share in the US and approaching blockbuster status outside the US [4][5] - Beyfortus sales reached EUR645 million in Q3, with exceptional market uptake in its second season [8] - ALTUVIIIO sales were EUR172 million, establishing it as a new standard of care in hemophilia A [8] - Nexviazyme, Rezurock, and Sarclisa contributed EUR1.4 billion in sales in Q3 [8] - Opella grew 8%, driven by the strategic acquisition of Qunol in the US [4] Market Performance - Dupixent's COPD indication was approved in the US and China, following EU approval four months prior, expanding its market potential [5] - Beyfortus demonstrated 87% efficacy in reducing RSV hospitalization rates in the US, with real-world evidence supporting its effectiveness [9] - Fluzone High-Dose showed 24% superior efficacy compared to standard-dose flu vaccines in a randomized controlled trial [10] - Beyfortus is expected to reach EUR1.5 billion in sales for 2024, with additional capacity supporting Q4 sales [13] Strategic Direction and Industry Competition - The company is focusing on geographic expansion, with around 30 potential country launches for Dupixent by 2026 [6] - Dupixent's growth is supported by penetration into new indications like COPD and chronic spontaneous urticaria (CSU) [6] - The company is advancing its ESG commitments, including ensuring a living wage for employees and improving supply chain partner well-being [10][11] - Sanofi is transitioning to a pure-play biopharma company, with plans to sell a controlling stake in Opella to CD&R for EUR16 billion EV [15] Management Commentary on Operating Environment and Future Outlook - Management expressed confidence in Dupixent's growth, targeting a low-double-digit sales CAGR between 2023 and 2030 [7] - The company expects strong growth in 2025, with business EPS increasing over 2024, even without Opella [33] - R&D expenses are aligned with the company's commitment to innovation, with EUR700 million in increased R&D costs for 2024 [14] - The company is focused on bolt-on acquisitions and maintaining a strong credit rating, avoiding large acquisitions [17] Other Important Information - The company is investing in external innovation, including partnerships with MeiraGTx, Ventyx, AnaptysBio, and Vicore [19] - Sanofi completed a licensing agreement with RadioMedix and Orano Med for AlphaMedix, a radioligand for rare cancers [20] - The company is advancing its pipeline with six Phase 3 readouts, 11 submissions, and 10 regulatory decisions planned over the next 18 months [24] Q&A Session Summary Question: Beyfortus Commercial Potential and Opella Deal Proceeds [25] - Management highlighted Beyfortus' strong market position and potential for growth, with confidence in its efficacy and safety data [26] - The Opella deal is expected to generate high-single-digit billion euros in proceeds, with debt pass-through and tax considerations [28] Question: Dupixent COPD Launch Metrics and Opella Proceeds [30] - Early feedback on Dupixent's COPD launch has been positive, with expectations for significant market penetration [31] - The company clarified that the dilution from Opella's sale will be absorbed, with business EPS expected to increase in 2025 [33] Question: Beyfortus Market Penetration and Buyback Authority [34] - Beyfortus is launched in close to 20 countries, with plans for further expansion in 2025 [35] - The company is actively discussing buybacks with the Board and will communicate capital allocation decisions when ready [36] Question: Amlitelimab Strategy and Growth Recovery [37] - Amlitelimab's OX40 ligand pathway is seen as a key differentiator, with potential for significant impact in asthma and other inflammatory diseases [39] - The company expects strong growth recovery in 2025, with accelerated business EPS growth in 2024 [40] Question: Opella Financial Reporting and Tax Rate [43] - Opella's financials will be reported as a discontinued operation in 2024, with an expected underlying tax rate of around 20% [44] Question: IRA Impact and Dupixent Payer Negotiations [45] - The Inflation Reduction Act (IRA) is seen as a mixed impact, with some provisions benefiting patients but potentially limiting innovation [45] - Dupixent's payer negotiations are supported by strong demand growth and a clear strategy for expanding access [45] Question: Stranded Costs and Vaccine Phase 3 Trials [47] - Stranded costs from Opella are not expected to be material, with sales and marketing investments continuing into 2025 [48] - The company is on track to start Phase 3 trials for its 21-valent pneumococcal vaccine in 2024 [50] Question: Radioligand Strategy and Supply Chain [54] - Sanofi is excited about the radioligand space, particularly Lead-212, which has shown promise in rare cancers [56] - The company is confident in its supply chain capabilities, working with Orano Med to ensure timely delivery [57] Question: Beyfortus Capacity and BPI Influence [60] - Beyfortus capacity has been tripled in 2024, with no anticipated supply constraints in 2025 and 2026 [62] - BPI France's influence on Opella is limited, with a 1-2% stake and minimal governance impact [63] Question: Beyfortus Durability and Pneumococcal Vaccine [65] - Beyfortus has demonstrated 83% efficacy against RSV hospitalization after six months, with no waning efficacy [65] - The company is on track to start Phase 3 trials for its 21-valent pneumococcal vaccine in 2024 [68] Question: OX40 Ligand and Pipeline Readouts [70] - Sanofi remains confident in the OX40 ligand pathway, with differentiation from competitors like Amgen [72] - The company plans to disclose pipeline readouts at scientific congresses, with material results communicated promptly [73] Question: Beyfortus Growth and RSV Market Potential [74] - Beyfortus is expected to grow in 2025, regardless of competition, with a focus on all-infant protection [75] - The RSV market potential remains strong, with additional opportunities in pediatric RSV vaccines [75] Question: Beyfortus Dosing and Opella Proceeds [78] - Beyfortus' dosing strategy is tailored to different channels, with no significant disadvantage compared to competitors [80] - Opella proceeds are expected to be high-single-digit billion euros, net of taxes and transaction costs [81] Question: Dupixent LOE and Anti-TL1A Update [82] - Dupixent's LOE is expected in 2031 in the US and 2033 in Europe, with additional patents extending protection [82] - Anti-TL1A data is expected in H2 2024, with updates from Teva and Sanofi [84] Question: Hidradenitis Suppurativa Strategy and Beyfortus Capacity [87] - Sanofi is pursuing a franchise strategy in Hidradenitis Suppurativa, with multiple mechanisms of action under development [89] - Beyfortus capacity has been tripled, with no supply constraints anticipated for 2025 [92] Closing Remarks [93] - Sanofi reaffirmed its strong business momentum, with continued execution on launches and pipeline advancements, aiming to become a pure-play biopharma leader [93]

Sanofi (SNY) reported third-quarter 2024 adjusted earnings of $1.57 per American depositary share, which beat the Zacks Consensus Estimate of $1.35 per share. Earnings of €2.86 per share rose 12.2% on a reported basis and 17.6% on a constant currency rate (“CER”) basis.Net sales rose 12.3% on a reported basis to $14.77 billion (€13.44 billion). Exchange rate movements hurt sales by 3.4% in the quarter. Sales rose 15.7% on a CER basis. Sales beat the Zacks Consensus Estimate of $14.39 billion.Sales rose 23.6 ...

On Friday, Sanofi SA SNY reported a third-quarter business operating income of 4.61 billion euros ($4.99 billion), up 14.4% year-over-year and 19.9% in constant currency.The company reported third-quarter sales of 13.44 billion euros or $14.79 billion, beating the consensus of $13.97 billion.Sales increased 12.3% year over year and 15.7% on constant currency, led by solid growth from Dupixent, Pharma launches, vaccines, and Opella.The French drugmaker reported adjusted EPS of 2.86 euros or $1.57, up 12.2% ( ...

Sanofi (SNY) has entered into exclusive negotiations with U.S.-based private equity company Clayton Dubilier & Rice (CD&R) for the potential sale of a 50% controlling stake in its consumer healthcare (CHC) business unit, Opella.Per the terms of the deal, Sanofi will remain a significant shareholder of Opella. In addition, the French investment bank, Bpifrance, is likely to hold a 2% stake and become a minority shareholder in Opella.The transaction is expected to close at the earliest in the second quarter o ...

Core Viewpoint - Sanofi and CD&R are entering exclusive negotiations for the potential sale of a 50% controlling stake in Opella, aiming to enhance Opella's position as a global leader in consumer healthcare while allowing Sanofi to focus on innovative biopharmaceuticals [1][3]. Company Overview - Opella, headquartered in France, employs over 11,000 people and operates in 100 countries with 13 manufacturing sites and four R&D centers. It is the third-largest player in the OTC and VMS market, serving over 500 million consumers globally [2]. - The company has a portfolio of well-known brands, including Allegra, Doliprane, and Dulcolax, and is positioned in a fast-growing industry driven by trends such as an aging population and increased health awareness [2]. Transaction Details - The enterprise value of Opella is approximately €16 billion, equating to about 14 times the estimated EBITDA for 2024. The transaction is binding and fully financed by CD&R [3]. - Sanofi will retain a significant minority stake in Opella, allowing it to benefit from future value creation [3]. - The transaction is expected to close in Q2 2025, subject to final agreements and regulatory approvals [3]. Strategic Implications - The partnership with CD&R is expected to leverage their expertise and resources to enhance Opella's market leadership and accelerate growth [4][6]. - Sanofi's focus will shift towards delivering innovative medicines and vaccines, while still supporting Opella's growth as an independent entity [5][6]. Financial Guidance - Sanofi has upgraded its 2024 business EPS guidance, now expecting low single-digit percentage growth at constant exchange rates, excluding Opella from its consolidated results [8]. - The anticipated cash payment from the transaction will align with Sanofi's capital allocation priorities, including shareholder returns and potential external growth opportunities [9].

BRIDGEWATER, N.J., Oct. 16, 2024 /PRNewswire/ -- Sanofi announced today it will contribute $18 million to three Historically Black Medical Schools to help the institutions work to increase diversity in clinical studies. The investment over 10 years is aimed at strengthening Centers of Excellence in clinical study diversity at Howard University College of Medicine, Meharry Medical College, and Morehouse School of Medicine. Funding will be used to hire clinical research staff, establish infrastructure such as ...