Full Press Release Details
| 2 | HALF-YEAR MANAGEMENT REPORT | 38 | |
| A Significant events of the first half of 2023 | 38 | ||
| B Progress on implementation of the Corporate Social Responsibility strategy | 41 | ||
| C Events subsequent to June 30, 2023 | 43 | ||
| D Consolidated financial statements for the first half of 2023 | 44 | ||
| E Risk factors and related party transactions | 60 | ||
| F Outlook | 61 | ||
| G Appendix - Research and Development Pipeline | 63 | ||
| 3 | STATUTORY AUDITORS' REPORT | 66 | |
| 4 | RESPONSIBILITY STATEMENT OF THE CERTIFYING OFFICER - HALF-YEAR FINANCIAL REPORT | 67 |
| A SIGNIFICANT EVENTS OF THE FIRST HALF OF 2023 |
| A.1. FIRST-HALF OVERVIEW |
During the first half of 2023, Sanofi continued to implement its "Play to Win" strategy, initiating the second phase which aims to launch major innovations, redeploy resources and develop leading innovative R D. Significant events connected with the implementation of that strategy are described below (for additional information on developments related to Research and Development see also section "A.2. Research and Development").
On January 11, 2023, Sanofi Ventures announced an additional multi-year commitment from Sanofi, which will increase the capital of the evergreen venture fund to more than $750 million. In addition to serving as a financial partner to top-tier early-to-mid-stage portfolio companies, the fund supports future efforts for business development and M A opportunities within Sanofi. The additional capital, confirmed by our Executive Committee, will also fuel the expansion and investment capacity of the Sanofi Ventures investment team on a global scale.
On March 13, 2023, Sanofi and Provention Bio, Inc. ("Provention"), a US-based publicly-traded biopharmaceutical company developing therapies to prevent and intercept immune-mediated diseases including type 1 diabetes, entered into an agreement under which Sanofi acquired the outstanding shares of Provention common stock for $25.00 per share in an all-cash transaction valued at approximately $2.8 billion. On April 27, 2023, Sanofi announced the completion of its acquisition of Provention. The acquisition adds TZIELD (teplizumab-mzwv) - an innovative, fully owned, first-in-class therapy in type 1 diabetes - to Sanofi's core General Medicines asset portfolio, and further drives our strategic shift toward products with a differentiated profile.
On April 9, 2023, Sanofi and AstraZeneca simplified their contractual agreements for the development and commercialization of Beyfortus (nirsevimab) in the US. Sanofi thereby obtained control of all commercial rights to Beyfortus (nirsevimab) in the US, and ended the sharing of commercial profits between the two partners in that territory. In accordance with IAS 38, Sanofi has recognized an intangible asset of 1,632 million for the fair value of the additional US rights. On the same date, AstraZeneca and Sobi ended their participation agreement, signed in 2018, which transferred the economic rights for US territory to Sobi.
That agreement is a financial transaction whereby Sanofi grants Sobi the right to receive future royalties. As regards that agreement, on April 9, 2023 Sanofi recognized a financial liability, presented within the line items Other non-current liabilities (in an amount of 1,609 million) and Other current liabilities (in an amount of 23 million). That liability is classified as a financial liability at amortized cost under IFRS 9. Other than royalty payments, subsequent movements in the liability comprise (i) the unwinding of discount and (ii) changes in estimates of future cash outflows for royalty payments. Those movements will be recognized in the income statement within Net financial income (expenses) in accordance with IFRS 9.
With respect to territories outside the US, the existing Collaboration Agreement between AstraZeneca and Sanofi continues to govern that relationship (with the exception of China, which is now defined as a "major market", with a 50 50 profit loss share with AstraZeneca).
On June 20, 2023, Sanofi announced that in a dispute referred to the International Chamber of Commerce arbitration panel, the panel had dismissed an indemnification claim against Sanofi from Boehringer Ingelheim and confirmed that Sanofi will not be liable for any potential losses in relation to the ongoing Zantac litigation in the US. This decision is final and non-appealable.
On June 29, 2023, Sanofi hosted a Vaccines Investor Event dedicated to its vaccines pipeline with key members of its leadership team. The event highlighted how Sanofi's strategy is supported by Vaccines R D, with the aim of developing first-in-class or best-in-class products. Since 2019, reinvesting in key growth drivers and a renewed pipeline has positioned Sanofi well as it moves at speed on the second phase of its Play to Win strategy. Sanofi also reiterated its ambition of generating annual net sales in excess of 10 billion from vaccines by 2030 as innovation efforts gather pace.
Net sales for the first half of 2023 amounted to 20,187 million, 2.0% higher than in the first half of 2022. At constant exchange rates (CER)(1), net sales rose by 4.4%, driven mainly by strong performances for Dupixent . The year-on-year increase also reflects the launch of Nexviazyme and growth in Vaccines, driven largely by sales of the COVID-19 vaccine.
Net income attributable to equity holders of Sanofi amounted to 3,430 million in the first half of 2023, versus 3,184 million in the first half of 2022. Earnings per share was 2.74, versus 2.55 for the first half of 2022. Business net income(2) was 4,876 million, up 6.1% on the first half of 2022, while business earnings per share (business EPS2) was 3.90, 6.0% higher than in the first half of 2022.
(1) Non-IFRS financial measure see definition in D.3., "Net sales".
(2) Non-IFRS financial measure see definition in D.2., "Business net income".
During the first half of 2023, Sanofi maintained its R D efforts with the aim of improving quality of life for people around the globe by developing innovative vaccines and medicines.
The US Food and Drug Administration (FDA) approved ALTUVIIIOTM (efanesoctocog alfa), a first-in-class, high-sustained factor VIII replacement therapy, indicated for routine prophylaxis and on-demand treatment to control bleeding episodes, as well as perioperative management (surgery) for adults and children with hemophilia A. ALTUVIIIOTM is the first and only hemophilia A treatment that delivers normal to near-normal factor activity levels (over 40%) for most of the week with once weekly dosing, and significantly reduces bleeds compared to prior factor VIII prophylaxis.
The approval was based on data from the pivotal XTEND-1 Phase III study in adults and adolescents with hemophilia A recently published in the New England Journal of Medicine showing the efficacy, safety and pharmacokinetic profile of efanesoctocog alfa.
Dupixent (dupilumab) was approved in the European Union and China to treat severe atopic dermatitis in children aged 6 months to 5 years old who are candidates for systemic therapy. With this approval, Dupixent became the first and only targeted medicine indicated to treat these young children in Europe, China and the US.
Dupixent was also approved in the European Union to treat eosinophilic esophagitis (EoE) in adults and adolescents 12 years and older weighing at least 40 kg who are inadequately controlled by, intolerant to, or not candidates for conventional medicinal therapy. With this approval, Dupixent became the first and only targeted medicine specifically indicated to treat EoE in Europe and the US.
The FDA accepted for review the supplemental Biologics License Application (sBLA) for Dupixent to treat adults and adolescents aged 12 years and older with chronic spontaneous urticaria (CSU), not adequately controlled with the current standard of care (H1 antihistamine treatment), with a decision date of October 22, 2023. An application was also submitted to the Pharmaceuticals and Medical Devices Agency (PDMA) in Japan.
Nirsevimab (which will be commercialized under the name Beyfortus (nirsevimab)) was approved in Europe, the United Kingdom and Canada (see also section "C Events subsequent to June 30). It was also accepted for priority review in China, and filed for approval in Japan.
On June 8, 2023,the Antimicrobial Drugs Advisory Committee, (AMDAC) of the FDA voted unanimously that nirsevimab has a favorable benefit risk profile for the prevention of lower respiratory tract disease (LRTD) due to respiratory syncytial virus (RSV) in newborns and infants born during or entering their first RSV season. The AMDAC also expressed a favorable opinion on the benefit risk profile of nirsevimab for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season.
Dupixent demonstrated a clinically meaningful and highly significant reduction (30%) in moderate or severe acute exacerbations (rapid and acute worsening of respiratory symptoms) of chronic obstructive pulmonary disease (COPD) in the pivotal BOREAS study, along with significant improvements in lung function, quality of life and COPD respiratory symptoms. Efficacy and safety results from this trial were presented at the American Thoracic Society (ATS) Conference, and published in the New England Journal of Medicine. A second Phase III trial of Dupixent in COPD (NOTUS) is ongoing, with data expected in 2024.
Positive results from two Phase III Dupixent trials in adults with uncontrolled prurigo nodularis have been published in Nature Medicine. These first published Phase III results in this disease show Dupixent significantly reduced itch (the primary endpoint) and skin lesions compared to placebo. Dupixent also significantly improved health-related quality of life while reducing measures of skin pain and symptoms of anxiety depression. Results from the trials were the basis for the FDA approval of Dupixent in September 2022, and the European Medicines Agency approval of Dupixent in December 2022. Dupixent is the only approved biologic indicated for prurigo nodularis in the US and EU.
A Phase III study evaluating Dupixent in Chronic Inducible Cold Urticaria (LIBERTY-CINDU) did not meet the required efficacy endpoints to continue this program.
Dupixent programs in Allergic Fungal Rhinosinusitis (AFRS) and Chronic Rhinosinusitis without Nasal Polyps (CRsNP) will be discontinued due to portfolio prioritization.
Itepekimab, a fully human monoclonal antibody that binds to and inhibits interleukin 33 (IL-33) - which triggers and amplifies the inflammation that causes Chronic Obstructive Pulmonary Disease (COPD) - passed the futility assessment in a recent interim analysis of the studies in the AERIFY program. Because the assessment was conducted by an Independent Data Monitoring Committee (IDMC), Sanofi had no access to the data. Preclinical data evalating the blocking of IL-33 signaling, and its role in respiratory tract inflammation and lung remodeling, were resented to the congress of the American Thoracic Society (ATS).
New data for tolebrutinib from a collaborative research and development partnership with the National Institute of Neurological Disorders and Stroke (NINDS) showed a significant impact on neuroinflammatory biomarkers in the central nervous system associated with disease progression and addressing disability accumulation, which is a significant unmet need in multiple sclerosis. The data were presented at the Americas Committee for Treatment and Research in Multiple Sclerosis (ACTRIMS) Forum 2023.
Results from the ATLAS-INH and ATLAS A B studies evaluating the efficacy and safety of fitusiran (an investigational siRNA therapy for the prophylactic treatment of adults and adolescents with hemophilia A or B), reinforcing the potential of this therapy to transform the current standard of care and address unmet needs for all types of hemophilia regardless of inhibitor status, were published respectively in The Lancet and The Lancet Haematology.
Long-term extension data from the Phase III COMET study showing sustained treatment effect of Nexviazyme over nearly three years in late-onset Pompe disease patients (both treatment-naive patients who switched from alglucosidase alfa), were presented at WORLDSymposiumTM.
New data from the HARMONIE Phase IIIb clinical trial, showing an 83.21% reduction in hospitalizations due to RSV-related LRTD in infants under 12 months of age who received a single dose of nirsevimab compared to infants who received no RSV intervention, was presented to the 41st Annual Meeting of the European Society for the Prevention of Pediatric Infectious Diseases (ESPID).
The XTEND-Kids Phase III pivotal study evaluating the safety, efficacy and pharmacokinetics of ALTUVIIIOTM as once-weekly prophylaxis in previously treated children younger than 12 years with severe hemophilia A met its primary endpoint of safety, with no FVIII inhibitors detected.
For an update on our research and development pipeline, refer to Section G of this half-year management report.
| A.3. OTHER SIGNIFICANT EVENTS |
| A.3.1 CORPORATE GOVERNANCE |
The Combined General Shareholders' Meeting of Sanofi was held on May 25, 2023 at the Palais des Congr s in Paris (75017), under the chairmanship of Serge Weinberg, whose term of office expired at the close of the meeting. All resolutions submitted to the vote were adopted by the shareholders. Decisions taken by the General Meeting included approving the individual company and consolidated financial statements for the year ended December 31, 2022 distributing an ordinary annual dividend of 3.56 per share and approving the appointment of Fr d ric Oud a as an independent director. The Board of Directors, in its meeting held after the General Meeting, appointed Fr d ric Oud a as Chairman of the Board of Directors to succeed Serge Weinberg, whose term of office could not be renewed because he had reached the age limit stipulated in our Articles of Association. On a proposal from the Appointments, Governance and CSR Committee, Fr d ric Oud a was appointed as Chair of the Strategy Committee and as a member of the Appointments, Governance and CSR Committee and the Scientific Committee. The Board of Directors has 16 members, of whom six are women and two are directors representing employees. The Board of Directors retains a large majority of independent directors.
For a description of the most significant developments in legal and arbitration proceedings since publication of the financial statements for the year ended December 31, 2022, refer to Note B.14. to the condensed half-year consolidated financial statements.
The following events have occurred in respect of litigation, arbitration and other legal proceedings in which Sanofi and its affiliates are involved
The investigation by the State Attorney General Office in New York relating to Sanofi's trade and pricing practices for its insulin products and or Lantus has been closed.
Mylan vs Sanofi antitrust complaint
In May 2023, Mylan Pharmaceuticals Inc., Mylan Specialty L.P. and Mylan Inc. ("Mylan") filed suit against Sanofi-Aventis US LLC, Sanofi S.A., Aventis Pharma S.A. and Sanofi-Aventis Puerto Rico ("Sanofi") in the Western District of Pennsylvania for alleged antitrust violations related to Mylan's insulin product Semglee .
On June 1, 2023. Sanofi launched Action 2023, a global employee share ownership plan open to 84,000 employees in 56 countries. The program, like those carried out since 2013, clearly demonstrates the ongoing commitment of Sanofi and its Board of Directors to involve all employees, across all its territories, in the future development and results of the company.
The shares were offered at a subscription price of 79.58, representing a 20% discount to the average of the 20 opening prices of Sanofi shares from May 3 to May 30, 2023. In addition, for every five shares subscribed, employees were entitled to receive one free share (up to a maximum of four free shares per employee). Each employee was able to purchase up to 1,500 Sanofi shares, subject to the maximum legal limit set at 25% of their gross annual salary minus any voluntary payments already made under employee savings schemes (Group Savings Plan and or Group Retirement Savings Plan) during 2023.
B Corp Certification granted to CHC North America in recognition of environmental and social achievements
Sanofi Consumer Healthcare North America has earned B Corp Certification, becoming the first, large consumer healthcare company with B Corp certification. Sanofi CHC U.S. joins the select and growing B Corp community of businesses that meet high standards of social and environmental performance, accountability, and transparency. This certification recognizes Sanofi CHC's sustainability strategy, which is centered around better self-care for healthier people and a healthier planet.
Some of the sustainability highlights from Sanofi Consumer Healthcare North America include
Reduced operational (scopes 1 and 2) greenhouse gas emissions of Sanofi CHC North America manufacturing site by 77% in 2022 vs 2019
Powers its North American manufacturing and distribution site with 100% renewable electricity since 2020 as part of the goal to achieve 100% renewable electricity by 2025 for all manufacturing operations globally
Reached 41% representation of women in senior leadership roles as part of goal to reach 50 50 gender parity in senior leadership positions by 2025
Provides access to organized sports opportunities for Canadian youth facing socio-economic barriers via a partnership with KidSport Canada as part of global goal to reach 5 million people by 2030 through on-the-ground programs.
Sanofi continues its progress to improve access to medicines
Sanofi partnering with the Ghana Ministry of Health to improve affordable access to diabetes care
In order to offer solutions adapted to local needs, Sanofi is piloting a new business model in selected low-and middle-income countries to increase access to insulin. Countries are chosen based on their governments committing to tackle non-communicable diseases (NCDs) the priority of diabetes on their healthcare agenda and government interest in incorporating analog insulins, recently included in the WHO EML (WHO Model List of Essential Medicines).
These innovative partnerships with healthcare authorities will provide the blueprint to scale up the program within the pilot country, as well as to expand to other countries over the next three to five years. By rolling out this new business model, we are aiming to improve the lives of 190,000 people living with either Type 1 or Type 2 diabetes within the next 5 years.
The recently signed Ghana-Sanofi partnership delivered through Sanofi's General Medicines Business Unit and in close collaboration with the Ministry of Health of Ghana and other stakeholders and partners includes high-quality analogue insulins at affordable price (included in WHO EML now), patient disease awareness, HCP training, regional care centers, and digital solutions.
Sanofi capping its insulin to a $35 out-of-pocket costs in the U.S.
Sanofi has decided that it will cut the list price of Lantus (insulin glargine injection), its most widely prescribed insulin in the U.S., by 78%. The company will also establish a $35 cap on out-of-pocket costs for Lantus for all patients with commercial insurance, underscoring its longstanding commitment to offer affordable access to medicines. These steps will become effective January 1st, 2024.
Sanofi will continue to provide different programs to ensure access and affordability to diabetes patients depending on their coverage situations and will continue to monitor policy and market changes. Our suite of innovative programs includes
100% of commercially insured people are eligible for Sanofi's copay assistance programs, regardless of income or insurance plan design, which, in 2022 limited out-of-pocket expenses for a majority of participating patients to $15 or less for their diabetes medicines for a 30-day supply.
100% of uninsured people are eligible for the Insulins Valyou Savings Program - regardless of income level - enabling them to buy one or multiple Sanofi insulins at $35 for a 30-day supply.
We also provide free medications to qualified low- and middle-income patients through the Sanofi Patient Connection program. Some people facing an unexpected financial hardship may be eligible for a one-time, immediate month's supply of their Sanofi medicine as they wait for their application to be processed.
Learn more about Sanofi's transparent approach to pricing in the U.S. in the company 2023 U.S. Pricing Principles Report.
Launch of "A Million Conversations"
A Million Conversations is Sanofi's global initiative to rebuild trust in healthcare with the underrepresented, especially with Black and ethnic minority groups, women, people with disabilities, and LGBTQ+ communities. Sanofi aims to help build the next generation of diverse healthcare leaders.
In partnership with leading higher education institutions across the world, the Sanofi NextGen Scholarship will identify up to 100 new students from marginalized communities each year. Selected Scholars will be awarded funding to cover partial university fees and living costs. And they will receive development support, mentorship, internship opportunities, and potential employment once they graduate.
Inclusivity targets implemented across clinical trials with 45% of U.S. trials achieved at least 1 target
Sanofi strives to ensure trials are inclusive by design and represent the diversity of the patient populations who are living with the studied disease. Sanofi is partnering with historically underrepresented racial and ethnic minority communities as well as other marginalized groups to break down access barriers.
Before starting a trial, Sanofi develops a holistic overview of the patient experience and disease demographics it intends to treat. These insights cover topics including social determinants of health, reasons for mistrust and healthcare access barriers.
Building on these insights, Sanofi sets inclusivity targets in line with the demographics of the disease. It also seeks to be inclusive through representative eligibility criteria, endpoints that matter to patients and ways to reduce trial participation burden on patients.
As of June 2023, 22 trials in the U.S. with last patient in (LPI) expected this year have achieved
5% of the clinical trials achieved all inclusivity targets
27% of the clinical trials already achieved at least 2 inclusivity targets
45% of the clinical trials have already achieved at least 1 inclusivity target.
Inclusivity targets in the U.S. are defined by aligning with the demographics of the disease for the following communities Asian, Black, Hispanic.
Sanofi continues its progress to limit its impact on the environment
Net Zero emissions by 2045 and updated scope 3 targets validated by Science Based Targets Initiative (SBTi)
Sanofi announced in Q4 2022 it accelerates its efforts to address climate change and has built an ambitious path to achieve Net Zero emissions across all operations (scope 1 2) and the entire value chain (scope 3) by 2045. This target has been vetted by SBTi as well our updated scope 3 reduction target of achieving -30% GHG emissions by 2030 vs our 2019 baseline.
Net Zero emissions means achieving a scale of value chain emissions reductions consistent with the depth for abatement at the point of reaching global net-zero in 1.5 C pathways and neutralizing the impact of any residual emissions by permanently removing an equivalent volume of CO2e.
Sanofi inaugurated its first self-consumption photovoltaic park on its Montpellier site in France
Sanofi and EDF ENR inaugurated a new 3.3-hectare photovoltaic park at Sanofi's research and development site in Montpellier. The park is producing electricity that is fully self-consumed by the site since February 2023.
With an annual electricity production of 5,490 MWh, i.e. the equivalent of the consumption of a city of 4,000 people, this photovoltaic park, which will be supplemented by a ground-based power station in 2024 covers 17.5% of the annual electricity needs from the site. The rest of these needs are covered by a supply of 100% renewable electricity.
This project is part of our larger ambition to use 100% renewable electricity by 2030 worldwide. Beyond the Montpellier site, other large-scale solar power plant installations are planned for the Aramon site in July 2023, the Ambar s site in 2024 and the Sisteron site in the near future. Similar plants are already in operation at the sites of Virginia in Australia, Goa in India and Scoppito in Italy.
Pilot take-back programs for insulin pens launched in 2 European countries
As part of Sanofi's eco design commitment, the company is developing solutions to tackle the end-of-life of its products. In several countries, take-back programs have been launched to collect injection pens and recycle them.
In Germany, Sanofi started a collaboration with 35 pharmacies in Berlin since April 2023 and plans to expand the program to more pharmacies across the country. The objective is to reach a take-back rate of 30 percent of SoloStars pens within one year.
In Denmark, Sanofi has partnered with Novo Nordisk, Eli Lilly and MSD to pioneer the world's first cross-industry solution for recycling injection pens. The collaboration has been launched in Denmark, because of the existing recycling infrastructure. The four companies distribute around 6 million injection pens in Denmark annually. The ambition for the first 12 months is to recycle 25% of all injection pens distributed by the four partners in Denmark. This target represents the equivalent of 25 tons of plastic waste.
CSR dashboard as of Q2 2023
Please refer to the Q2 2023 results press release ESG appendix for Sanofi CSR reporting.
On July 17, 2023, the US Food and Drug Administration (FDA) approved Sanofi and AstraZeneca's Beyfortus (nirsevimab) for the prevention of respiratory syncytial virus (RSV) lower respiratory tract disease (LRTD) in newborns and infants born during or entering their first RSV season, and for children up to 24 months of age who remain vulnerable to severe RSV disease through their second RSV season. The companies plan to make Beyfortus (nirsevimab) available in the United States ahead of the upcoming 2023-2024 RSV season.
On July 20, 2023, Sanofi entered into a collaboration agreement with Recludix Pharma to develop and commercialize novel STAT6 inhibitors for patients with immunological and inflammatory diseases. Under the terms of the agreement, Sanofi will make an upfront payment of $75 million and could pay up to $1.2 billion contingent on the attainment of certain objectives. In addition, Recludix would also receive royalties on sales of commercialized products and has an option to participate equally with Sanofi in US profit loss sharing.
On July 27, 2023, Sanofi entered into an agreement to acquire QRIB intermediate Holdings, LLC, a privately-owned company, which owns Qunol , a U.S.-based, market-leading brand in health wellness for a cash purchase price of ca. 1.4 billion dollars. This transaction will strengthen Sanofi Consumer Healthcare's Vitamin, Mineral and Supplements (VMS) category. The acquisition is expected to close in the third quarter of 2023 subject to customary closing conditions, including applicable regulatory approvals, following which Sanofi would have control over QRIB intermediate Holdings, LLC.
Unless otherwise indicated, all financial data in this report are presented in accordance with international financial reporting standards (IFRS), including international accounting standards and interpretations (see Note A.1. to the condensed half-year consolidated financial statements).
Consolidated income statements for the six months ended June 30, 2022 and June 30, 2023
| ( million) | June 30, 2023 (6 months) | as % of net sales | June 30, 2022 (6 months) | as % of net sales | |||||
| Net sales | 20,187 | 100.0 | % | 19,790 | 100.0 | % | |||
| Other revenues | 1,358 | 6.7 | % | 1,005 | 5.1 | % | |||
| Cost of sales | (6,347) | (31.4) | % | (6,130) | (31.0) | % | |||
| Gross profit | 15,198 | 75.3 | % | 14,665 | 74.1 | % | |||
| Research and development expenses | (3,193) | (15.8) | % | (3,147) | (15.9) | % | |||
| Selling and general expenses | (5,182) | (25.7) | % | (4,953) | (25.0) | % | |||
| Other operating income | 617 | 416 | |||||||
| Other operating expenses | (1,422) | (1,204) | |||||||
| Amortization of intangible assets | (1,035) | (910) | |||||||
| Impairment of intangible assets | (15) | (87) | |||||||
| Fair value remeasurement of contingent consideration | (26) | (17) | |||||||
| Restructuring costs and similar items | (547) | (792) | |||||||
| Other gains and losses, and litigation | (73) | (142) | |||||||
| Operating income | 4,322 | 21.4 | % | 3,829 | 19.3 | % | |||
| Financial expenses | (370) | (189) | |||||||
| Financial income | 286 | 34 | |||||||
| Income before tax and investments accounted for using the equity method | 4,238 | 21.0 | % | 3,674 | 18.6 | % | |||
| Income tax expense | (730) | (495) | |||||||
| Share of profit (loss) from investments accounted for using the equity method | (52) | 58 | |||||||
| Net income | 3,456 | 17.1 | % | 3,237 | 16.4 | % | |||
| Net income attributable to non-controlling interests | 26 | 53 | |||||||
| Net income attributable to equity holders of Sanofi | 3,430 | 17.0 | % | 3,184 | 16.1 | % | |||
| Average number of shares outstanding (million) | 1,249.9 | 1,250.0 | |||||||
| Average number of shares after dilution (million) | 1,254.5 | 1,255.3 | |||||||
| Basic earnings per share (in euros) | 2.74 | 2.55 | |||||||
| Diluted earnings per share (in euros) | 2.73 | 2.54 |
| D.1. SEGMENT INFORMATION |
| D.1.1. OPERATING SEGMENTS |
In accordance with IFRS 8 (Operating Segments), the segment information reported by Sanofi is prepared on the basis of internal management data provided to our Chief Executive Officer, who is the chief operating decision maker of Sanofi. The performance of those segments is monitored individually using internal reports and common indicators. The operating segment disclosures required under IFRS 8 are provided in Note B.20. to the condensed half-year consolidated financial statements.
In 2022, Sanofi reported three operating segments (Pharmaceuticals, Vaccines and Consumer Healthcare). The costs of the global support functions (Corporate Affairs, Finance, People Culture, Legal Affairs, Ethics Business Integrity, Information Solutions Technology, Sanofi Business Services, etc.), which are mainly managed centrally at group-wide level, were presented within the "Other" category.
In 2023, Sanofi reviewed the presentation of its segment information following adjustments to its internal reporting systems in order to reflect (i) progress on the "Play to Win" strategy leading to the creation of the standalone Consumer Healthcare Global Business Unit (GBU) which, in addition to integrated research, development and production functions now also has its own dedicated global support functions (including Finance, People Culture, Legal Affairs, Ethics Business Integrity, Information Solutions Technology, Global Business Services, etc.) and (ii) organizational changes to Sanofi's Manufacturing Supply global function (previously known as Industrial Affairs).
Consequently, with effect from January 1, 2023, Sanofi reports two operating segments Biopharma and Consumer Healthcare.
The Biopharma operating segment comprises commercial operations and research, development and production activities relating to the Speciality Care, General Medicines and Vaccines franchises, for all geographical territories. The segment's results include the costs of global support functions that are not within the managerial responsibility of the Consumer Healthcare GBU.
The Consumer Healthcare operating segment comprises commercial operations relating to Consumer Healthcare products, and research, development and production activities and global support functions (as listed above) dedicated to the segment, for all geographical territories. The Consumer Healthcare GBU segment's results reflect all incurred costs of global support functions attributable to its business.