Opella Healthcare Group SAS

Sanofi is offloading its rare autoimmune disease medicine Enjaymo to an Italian pharmaceutical company for $825 million upfront. Recordati, based in Milan, said Friday it will pay up to an additional $250 million over time for the monoclonal antibody, which was greenlit in the US , Europe and Japan in 2022 for hemolysis in adults with cold agglutinin disease (CAD). In patients with the rare condition, their immune system prematurely demolishes red blood cells, and it can lead to severe anemia. Sanofi recorded €55 million ($60 million) in Enjaymo sales in the first six months of 2024, it said in July. Recordati predicts the drug could reach annual peak sales of €250 million to €300 million (about $275 million to $330 million). It marks a winding road for Enjaymo, which has gone through the full biotech-to-pharma journey. A Bay Area biotech called True North Therapeutics developed the drug and then was bought by Bioverativ for $400 million upfront in 2017. Less than 12 months later, Sanofi acquired Bioverativ for almost $11.6 billion. Two years after that, Sanofi was handed a rejection for the drug before it was approved in 2022. For Recordati, the deal pushes it further into the rare disease market. The company bought EUSA Pharma and its four rare disease drugs for nearly $850 million in December 2021. It’s also struck deals with GSK , Almirall and others in recent years. With “a strong clinical profile and as the only product approved for the treatment of CAD, Enjaymo addresses a serious unmet medical need for patients living with this debilitating disease,” Recordati CEO Rob Koremans said in a press release. Earlier this year, Sobi and Apellis Pharmaceuticals stopped a Phase 3 in CAD, citing “a decreased medical need in CAD and therefore a limited number of patients eligible for the study.” CAD affects about one person per million every year, according to the National Organization for Rare Disorders. The Recordati deal comes as Sanofi adjusts its portfolio. It now plans to hone in on immunology and inflammation under new R&D head Houman Ashrafian and new CSO Mike Quigley , who joined Sept. 30. It’s also planning to divest its consumer health group Opella. Earlier this year, Sanofi sold some early-stage cancer projects to Vir Biotechnology and shuttered a cell therapy unit, though it’s still making a few bets in oncology, including its first foray into radiopharma . The French drugmaker also has invested in several companies, including Ventyx, Vicore and Graviton.

Sanofi Q2: strong performance with 10% sales growth; 2024 guidance upgraded Paris, July 25, 2024 Q2 sales growth of 10.2% at CER and business EPS(1) of €1.73 Dupixent sales up 29.2% to €3,303 million; target of ~€13 billion in 2024 unchangedPharma launches up 80.4% to €689 million, led by ALTUVIIIO, Nexviazyme, Rezurock, and SarclisaVaccines sales -4.8% due to COVID-19 sales in 2023Opella (former Sanofi Consumer Healthcare) up 9.6%, driven by the Qunol acquisitionResearch and Development expenses grew 5.5%Selling, general and administrative expenses grew 4.9%, substantially less than sales growthBusiness EPS(1) of €1.73, down 0.6% reported and up 4.0% at CERIFRS EPS of €0.89, down 22.6% reported Q2 pipeline progress Three regulatory approvals; Dupixent COPD (EU, July), Kevzara pJIA (US), Altuvoct hemophilia A (EU)Four regulatory submissions, including fitusiran in hemophilia A/B and Sarclisa in multiple myelomaIncreasing pipeline news flow over 2024-2025, including 12 phase 3 data readouts Other key updates Sanofi ranked world’s 7th most sustainable company by TIME MagazineOpella (Consumer Healthcare) intended separation on track with previously communicated timelines* 2024 business EPS guidance upgraded 2024 business EPS(1) to be stable at CER(2), an upgrade from a low single-digit percentage decrease previously, underpinned by accelerated delivery of Sanofi’s pipeline-driven transformation. Applying the average July 2024 exchange rates, the currency impact on 2024 business EPS is c.-5.5% to -6.5%. Paul Hudson, Chief Executive Officer, commented: “We are continuing our strong performance in 2024 and delivered broad-based, double-digit sales growth in the second quarter. We also made important progress in our pipeline of new medicines, including approvals for Dupixent in COPD, Kevzara in pediatric arthritis and ALTUVIIIO (EU) in hemophilia A. With the EU approval in COPD, Dupixent is the first-ever biologic medicine approved in this debilitating disease impacting hundreds of thousands of patients globally. As we accelerate our focused mid- and late-stage pipeline, we started a number of new phase 2 and phase 3 studies that will benefit patients in the future. We are well on track, delivering on our strategic priorities for Sanofi to become a development-driven, tech-powered biopharma company committed to serving patients and accelerating growth. Underpinned by accelerated delivery of Sanofi’s transformation, we upgrade our earnings per share guidance for 2024.” Q2 2024 Change Change at CER H1 2024 Change Change at CER IFRS net sales reported € 10,745 m +7.8% +10.2% € 21,209 m +5.1% +8.4% IFRS net income reported € 1,113 m -22.4% — € 2,246 m -34.5% — IFRS EPS reported € 0.89 -22.6% — € 1.80 -34.3% — Free cash flow(3) € 854 m -46.4% — € 545 m -82.6% — Business operating income € 2,813 m +3.2% +8.3 % € 5,656 m -6.7% +1.4% Business net income(1) € 2,161 m -0.7% +4.0 % € 4,380 m -10.2% -2.3% Business EPS(1) € 1.73 -0.6% +4.0% € 3.51 -10.0% -2.3% Changes in net sales are expressed at constant exchange rates (CER) unless stated otherwise (definition in Appendix 9). (1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-IFRS financial measure (definition in Appendix 9). The consolidated income statement for Q2 and H1 2024 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) 2023 business EPS was €8.11; (3) Free cash flow is a non-IFRS financial measure (definition in Appendix 9). *Separation subject to market conditions and consultations of social partners and work councils. Attachment Press_Releasee