Press Release: Strong execution in Q2 drives full-year 2022 guidance upgrade and delivers rich R&D news flow in Immunology and Rare Disease

On July 28, 2022 Sanofi reported that Q2 2022 sales growth of 8.1% at CER driven by Dupixent, Rare Disease, Vaccines and CHC (Press release, Sanofi, JUL 28, 2022, View Source [SID1234617046])

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Specialty Care grew 21.6% driven by Dupixent (€1,963 million, +43.4%), and double-digit growth in Rare Disease
Vaccines up 8.7% due to strong rebound of Travel and Booster vaccines as well as continued PPH franchise growth
General Medicines achieved 6.0% growth in core assets despite lower COVID-19 related demand for Lovenox
CHC delivered 5th consecutive quarter of growth (+9.1%) driven by Cough & Cold, Allergy and Digestive Wellness
Q2 2022 business EPS(1) up 16.7% at CER driven by higher sales and improving margins

BOI margin up 1.3 ppt to 27.2% due to margin improvement from efficiency gains and EUROAPI deconsolidation
€2.6bn savings achieved at the end of Q2, with the majority reinvested in growth drivers and R&D
Business EPS(1) of €1.73, up 25.4% on a reported basis and 16.7% at CER
IFRS EPS of €0.94 (down 2.1%)
Progress on Corporate Social Responsibility strategy

Sanofi’s Global Health Unit launches a fund for healthcare solutions in underserved regions and Impact, a new brand dedicated for non-profit distribution of 30 Sanofi products to at-risk populations in 40 lower-income countries
Valyou program continues to improve access through lower out-of-pocket cost of insulins for uninsured patients in the U.S.
Sanofi upgraded its scope 3 GHG emission reductions ambition to -30% by 2030, unveiling low energy intensity vaccines facility
Key milestone and regulatory achievements on R&D transformation

Efanesoctocog alfa, the first factor VIII therapy to be granted FDA Breakthrough Therapy Designation for hemophilia A
Dupixent approved in the U.S as first treatment for adults and children aged 12 and older with eosinophilic esophagitis and as first biologic medicine for children aged 6 months to 5 years with moderate-to-severe atopic dermatitis
FDA accepted Dupixent for priority review in adults with prurigo nodularis
Nexviadyme and XenpozymeTM approved in EU
Next-generation COVID-19 booster demonstrated strong results against variants of concern, including Omicron
Full-year 2022 business EPS guidance revised upward

Sanofi now expects 2022 business EPS(1) to grow approximately 15%(2) at CER, barring unforeseen major adverse events. Applying average July 2022 exchange rates, the positive currency impact on 2022 business EPS is estimated between +7.5% to +8.5%
Sanofi Chief Executive Officer, Paul Hudson, commented:

"Our performance in the second quarter was again marked by higher sales across our key growth drivers and outstanding financial results leading us to upgrade our business EPS guidance for the full-year. Notably, we saw significant growth momentum from our Specialty Care business, mainly driven by Dupixent. While we continue to increase our investment in R&D, we delivered important pipeline milestones such as the approval of Dupixent in its fourth disease indication, Eosinophilic Esophagitis. Earlier this month, we had the opportunity to showcase at ISTH the transformative potential of efanesoctocog alfa, the first factor replacement therapy for hemophilia A to receive FDA Breakthrough Therapy Designation. We are also making great progress in advancing our fully integrated social impact strategy, notably in Affordable Access with the launch of Impact, a dedicated brand for non-profit distribution to enable the secure distribution of 30 Sanofi medicines in 40 lower-income countries. As we continue to deliver ahead of schedule on our Play to Win strategy, we are confident in our business outlook for the second half and as a result, we are reiterating our commitment to achieving the BOI margin target of 30% in 2022."

Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (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-GAAP financial measure (definition in Appendix 9). The consolidated income statement for Q2 2022 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) 2021 business EPS was €6.56; (3) Free cash flow is a non-GAAP financial measure (definition in Appendix 9).