Sarclisa is the first anti-CD38 treatment approved in China for patients with newly diagnosed multiple myeloma ineligible for transplant Approval based on positive results from the IMROZ phase 3 study that demonstrated Sarclisa in combination with bortezomib, lenalidomide, and dexamethasone (VRd) significantly improved progression-free survival, compared to VRd alone in transplant-ineligible newly diagnosed multiple myeloma Second approval in China in three weeks following the R/R MM indication announced o ...

Financial Performance - Q4 2024 sales growth of 10.3% at CER, with business EPS of €1.31 [1] - FY 2024 sales growth of 11.3% at CER, totaling €41.1 billion, exceeding sales targets [4] - Business EPS for FY 2024 reached €7.12, a 4.1% increase at CER, surpassing guidance [4] - IFRS net income for FY 2024 was €41,081 million, an 8.6% increase [3] - Free cash flow for FY 2024 was €5,955 million, a 19.6% decrease [6] Pipeline and R&D - Increased R&D investment to €7.4 billion, up 14.6% in 2024 [4] - Significant pipeline progress, including positive phase 3 results for rilzabrutinib and tolebrutinib [3] - 14 regulatory approvals for medicines and vaccines in 2024, with 21 regulatory submission acceptances [4] - Dupixent expected to reach sales of around €22 billion by 2030 [3] Strategic Initiatives - Intention to sell a controlling stake in Opella consumer health, expected to close in Q2 2025 [2] - Plan to execute a €5 billion share buyback program in 2025 [5] - Focus on becoming a science-driven biopharma company, supported by ongoing launches and pipeline developments [3] Product Performance - Dupixent sales increased by 16.0% to €3.5 billion in 2024 [4] - Beyfortus achieved blockbuster status with €1.7 billion in sales in its first full year [4] - Pharma launches contributed 11% of total sales, with ALTUVIIIO leading the growth [4] - Vaccines sales grew by 10.8% to €2.2 billion, driven by Beyfortus in Europe [4] Future Outlook - Anticipated mid-to-high single-digit percentage sales growth at CER in 2025 [5] - Expected strong rebound in business EPS with low double-digit percentage growth at CER in 2025 [5] - Confidence in mid-to-long-term growth prospects, supported by ongoing launches and pipeline developments [3] Dividend and Shareholder Returns - Proposed dividend of €3.92 for 2024, marking the 30th consecutive year of dividend increases [4]

Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Règlement général de l’Autorité des Marchés Financiers (Regulation of the French stock market authority) Sanofia French société anonyme with a registered share capital of 2,526,245,442 €Registered office : 46, avenue de la Grande Armée - 75017 Paris - FranceRegistered at the Paris Commercial and Companies Registry under n ...

Banco Santander Brasil (NYSE: BSBR ) is the third-largest private bank in Brazil and has its operations focused mainly on wholesale and retail segments. The Brazil-based bank is part of Santander Group ( SAN ), whichI am a researcher and operations manager at DM Martins Research. Previously, I contributed to TheStreet and currently write for platforms such as TipRanks and GuruFocus. Here at Seeking Alpha, my goal is to provide insightful analysis primarily on foreign equities, with a focus on emerging marke ...

Analyst’s Disclosure: I/we have a beneficial long position in the shares of SAN either through stock ownership, options, or other derivatives. I wrote this article myself, and it expresses my own opinions. I am not receiving compensation for it (other than from Seeking Alpha). I have no business relationship with any company whose stock is mentioned in this article. While this article may sound like financial advice, please observe that the author is not a CFA or in any way licensed to give financial advice ...

Sarclisa Approval and Market Impact - Sarclisa has been approved in the EU as the first anti-CD38 therapy in combination with VRd for treating transplant-ineligible newly diagnosed multiple myeloma (NDMM) based on the IMROZ phase 3 study [1] - This approval marks the third indication for Sarclisa in the EU, including two for relapsed or refractory multiple myeloma (R/R MM) and one for NDMM [6] - Sarclisa is currently approved in over 50 countries, including the US and EU, across three indications [4] Clinical Development and Mechanisms - Sarclisa (isatuximab) is a CD38 monoclonal antibody that induces antitumor activity through mechanisms such as apoptosis and immunomodulatory activity [3] - The drug is part of a patient-centric clinical development program, with several phase 2 and phase 3 studies across six potential indications [5] - Sanofi is evaluating a subcutaneous administration method for Sarclisa in clinical studies [5] Regulatory Milestones and Global Expansion - The US FDA approved Sarclisa in combination with VRd for NDMM in September 2024, granting orphan drug exclusivity for this indication [2] - Regulatory submissions for Sarclisa in NDMM are under review in Japan and China [2] - The approval in the EU and US represents a significant step forward in addressing unmet needs in multiple myeloma treatment [2][6] Sanofi's Strategic Focus - Sanofi is committed to advancing oncology innovation, focusing on difficult-to-treat cancers such as multiple myeloma, acute myeloid leukemia, and certain lymphomas [6][7] - The company aims to become the leading global immunoscience company by leveraging its expertise in this field [6] - Sanofi's pipeline prioritization includes hematologic malignancies and solid tumors with critical unmet needs [6]

Opella reaches study milestone for Cialis Paris, January 21, 2025. Opella, Sanofi’s Consumer Healthcare business, announced that the US Food and Drug Administration (FDA) has lifted a clinical hold on its planned actual use trial (AUT) to support the switch of Cialis (tadalafil) from a prescription to an over-the-counter medicine. This decision allows for the initiation of the AUT and makes Cialis the first PDE-5 inhibitor to achieve this milestone. AUTs evaluate the use of the medicine under real-world c ...

Information concerning the total number of voting rights and shares, provided pursuant to article L. 233-8 II of the Code de commerce (the French Commercial Code) and article 223-16 of the Règlement général de l’Autorité des Marchés Financiers (Regulation of the French stock market authority) Sanofia French société anonyme with a registered share capital of 2,537,214,304 €Registered office : 46, avenue de la Grande Armée - 75017 Paris - FranceRegistered at the Paris Commercial and Companies Registry under ...

Study Results - The IRAKLIA phase 3 study demonstrated that the subcutaneous (SC) formulation of Sarclisa, administered via an on-body delivery system (OBDS) in combination with pomalidomide and dexamethasone (Pd), met its co-primary endpoints of non-inferior objective response rate (ORR) and observed concentration before dosing (C trough) at steady state compared to intravenous (IV) Sarclisa in patients with relapsed or refractory multiple myeloma (R/R MM) [1] - Key secondary endpoints, including very good partial response (VGPR), incidence rate of infusion reactions, and C trough at cycle 2, were also achieved [1] - The study enrolled 531 patients across 252 global sites, with patients randomized to receive either SC or IV Sarclisa in combination with Pd for 28-day cycles until disease progression or other discontinuation criteria were met [4] Subcutaneous Formulation and OBDS - The SC formulation of Sarclisa, delivered via the enFuse OBDS, represents a potential new administration option for patients, offering comparable efficacy and safety to the IV formulation [2] - The enFuse OBDS, developed by Enable Injections, is designed to administer high-volume medicines subcutaneously through an automated drug delivery technology, featuring a hidden and retractable needle that is thinner than commonly used SC injection needles [2][7] - The IRAKLIA study is the first global phase 3 study to evaluate the SC administration of a cancer treatment via an OBDS, aiming to improve the patient experience and reduce time spent in healthcare facilities [5] Regulatory and Clinical Development - Regulatory submissions for the SC formulation of Sarclisa are planned in the US and EU during the first half of 2025 [3] - Additional studies evaluating Sarclisa SC formulations across different combinations and lines of therapy are ongoing, with the safety and efficacy of the SC formulation and enFuse device yet to be evaluated by regulatory authorities outside of their approved indications [3][8] About Sarclisa - Sarclisa (isatuximab) is a CD38 monoclonal antibody that targets MM cells through multiple mechanisms of action, including apoptosis and immunomodulatory activity [8] - Currently approved in more than 50 countries, Sarclisa is indicated for the treatment of R/R MM in combination with Pd or carfilzomib and dexamethasone, and as a front-line treatment option for newly diagnosed MM in combination with VRd [8] Sanofi's Strategic Focus - Sanofi is committed to advancing oncology innovation, with a focus on difficult-to-treat cancers such as multiple myeloma, acute myeloid leukemia, and certain lymphomas, as well as gastrointestinal and lung cancers [9] - The company continues to advance Sarclisa as part of a patient-centric clinical development program, with several phase 2 and phase 3 studies across the MM treatment continuum [8][9]

Duvakitug positive phase 2b results demonstrate best-in-class potential in ulcerative colitis and Crohn’s disease Primary endpoints met in ulcerative colitis (UC) and Crohn’s disease (CD), the most common forms of inflammatory bowel disease (IBD) Primary endpoint results in UC and CD for high dose represent the highest achieved with any TL1A monoclonal antibodySanofi and Teva plan to initiate phase 3 development in IBD, pending regulatory discussionsProgram underscores Sanofi's Immunology leadership ambitio ...