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Table of Contents 2 HALF-YEAR MANAGEMENT REPORT 40 A Significant events of the first half of 2021 40 B Events subsequent to

Key Takeaway: 2 HALF-YEAR MANAGEMENT REPORT 40 A Significant events of the first half of 2021 40 B Events subsequent to June 30, 2021 43 C Consolidated financial statements for the first half of 2021 44 D Risk factors and related party transactions 62 E Outlook 63 F Appendix - Rese

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2 HALF-YEAR MANAGEMENT REPORT 40
A Significant events of the first half of 2021 40
B Events subsequent to June 30, 2021 43
C Consolidated financial statements for the first half of 2021 44
D Risk factors and related party transactions 62
E Outlook 63
F Appendix - Research and Development Pipeline 65
3 STATUTORY AUDITORS' REPORT 67
4 RESPONSIBILITY STATEMENT OF THE CERTIFYING OFFICER - HALF-YEAR FINANCIAL REPORT 68
A SIGNIFICANT EVENTS OF THE FIRST HALF OF 2021
A.1. FIRST-HALF OVERVIEW
During the first half of 2021, Sanofi continued to implement its new "Play to Win" strategy, involving major decisions and positive actions that will support and rebuild the competitive margins necessary for Sanofi to continue to deliver on its mission. Significant events connected with the implementation of that strategy are described below.
On January 11, 2021, Sanofi and Kymab, a clinical-stage biopharmaceutical company developing fully human monoclonal antibodies with a focus on immune-mediated diseases and immuno-oncology therapeutics, announced that they had entered into an agreement under which Sanofi would acquire Kymab for an upfront payment of approximately $1.1 billion and up to $350 million contingent upon attainment of certain development milestones. On April 9, 2021, Sanofi announced that it had successfully completed this acquisition, thereby obtaining full global rights to KY1005, a fully human monoclonal antibody that targets the key immune system regulator OX40L and has the potential to treat a wide variety of immune-mediated diseases and inflammatory disorders.
On January 12, 2021, Sanofi unveiled EUROAPI as the name of the new industry-leading European company dedicated to the development, production and marketing of active pharmaceutical ingredients (API). Sanofi also announced the appointment of Karl Rotthier as the future Chief Executive Officer of EUROAPI effective January 18, 2021. Karl Rotthier, aged 53, is a seasoned leader with strong API business experience. He was most recently Chief Executive Officer of Centrient Pharmaceuticals. During a 29-year international career in the Netherlands, Germany, Austria, Belgium and Singapore, he has successfully driven a number of operational carve-outs and spin-offs. Karl will lead the creation of EUROAPI, working with the new company's management team to help EUROAPI deliver on its growth ambitions. An IPO on Euronext Paris is envisaged by 2022, subject to market conditions.
On February 12, 2021, Sanofi announced an all-cash offer to all holders of Kiadis shares, to acquire their shares at an offer price of 5.45 (cum dividend). Completion of the acquisition was announced on April 16, 2021. Kiadis is a clinical-stage biopharmaceutical company developing natural killer (NK) cell therapies for patients with potentially life-threatening diseases. NK cells seek and identify malignant cancer cells and have broad application across various tumor types. Kiadis's NK cell-based medicines will be developed alone and in combination with Sanofi's existing pipeline and platforms.
On March 31, 2021, Sanofi announced an investment of over 600 million in construction of a new vaccine manufacturing facility at its existing site in Toronto, Canada. The new facility will provide additional antigen and filling capacity for Sanofi's Fluzone High-Dose quadrivalent influenza vaccine, helping to increase supply availability in Canada, the United States and Europe. Sanofi expects this new facility to be operational in 2026, following design, construction, testing and qualification of the facility and equipment. Fluzone High-Dose quadrivalent influenza vaccine is currently manufactured exclusively by Sanofi Pasteur, Sanofi's vaccines global business unit, at its Swiftwater, Pennsylvania site in the United States. Sanofi Pasteur has an ongoing investment program expanding its manufacturing capabilities for influenza vaccines. Two new facilities, in Swiftwater and in Val-de-Reuil (France), will start to operate in the coming years.
On April 7, 2021, Sanofi's Chief Executive Officer Paul Hudson outlined several key projects that the company will implement to increase the impact of its Corporate Social Responsibility (CSR) strategy. Embedded in Sanofi's long-term strategy, the company's commitment is based on four essential pillars in which Sanofi is uniquely positioned to make a difference access to medicines, support for vulnerable communities, preservation of the environment, and inclusion and diversity of its employees.
On April 9, 2021, Sanofi acquired Tidal Therapeutics, a privately owned, pre-clinical stage biotech company with a novel mRNA-based approach for in vivo reprogramming of immune cells. The new technology platform will expand Sanofi's research capabilities in immuno-oncology and inflammatory diseases, and may have applicability to other disease areas as well. Sanofi acquired Tidal Therapeutics for an upfront payment of $160 million and up to $310 million contingent upon attainment of certain development milestones.
On April 12, 2021, Sanofi announced a 400 million investment over five years to create a one-of-a-kind vaccine production center in Singapore, pushing the boundaries of operations through cutting edge digital manufacturing technologies. In partnership with the Singapore Economic Development Board (EDB), the new site will mainly supply the Asian region and complement existing Sanofi manufacturing capacities in Europe and North America.
On May 6, 2021, Sanofi announced that it had entered into a three-year research collaboration with Stanford University School of Medicine. Together, the two organizations and their scientists will work to advance the understanding of immunology and inflammation through open scientific exchange. Additionally, Sanofi will provide funding and scientific inputs into projects of mutual interest, crossing multiple therapeutic areas including autoimmune diseases and inflammatory conditions.
On June 3, 2021, as part of a long-standing commitment to reduce the environmental footprint of the company's products and activities, Sanofi launched a 3 million Planet Mobilization fund to support employee ideas and projects that will further contribute to a healthier environment. This year, three Sanofi teams will have their projects funded.
On June 29, 2021, Sanofi announced that it will invest approximately 400 million annually in a first-of-its-kind mRNA vaccines Center of Excellence. The Center will work to accelerate the development and delivery of next-generation vaccines by bringing together approximately 400 dedicated employees and integrating end-to-end mRNA vaccine capabilities with dedicated R D, digital, and Chemistry, Manufacturing and Controls (CMC) teams across sites at Cambridge, MA (US) and Marcy l'Etoile, Lyon (France).
Net sales for the first half of 2021 amounted to 17,335 million, 0.9% higher than in the first half of 2020. At constant exchange rates (CER)1, net sales rose by 7.2%, driven mainly by strong performances for Dupixent . The year-on-year increase also reflects good performances by the Rare Diseases and Oncology franchises, and also from Vaccines as sales of Meningitis Vaccines picked up strongly relative to 2020. Sales of Consumer Healthcare products were up slightly year-on-year, with robust growth for the Digestive Wellness category more than offsetting lower sales in the Cough, Cold and Flu category.
Net income attributable to equity holders of Sanofi amounted to 2,776 million, versus 9,281 million in the first half of 2020. The decrease was mainly due to the recognition during the first half of 2020 of the 7,382 million gain on the divestment of Sanofi's equity investment in Regeneron following the transaction of May 29, 2020. Apart from that impact, operating income increased year-on-year due to reductions in (i) impairment losses taken against intangible assets and (ii) reductions in restructuring costs and similar items compared with the first half of 2020. Earnings per share was 2.22, versus 7.41 for the first half of 2020. Business net income2 was 3,748 million, up 6.4% on the first half of 2020, while business earnings per share (business EPS2) was 6.8% higher than in the first half of 2020 at 3.00.
Highlights of Sanofi's research and development efforts in the first half of 2021 in the Pharmaceuticals segment included the launch a Phase III trial (XTEND-Kids) evaluating efanesoctocog alfa (BIVV001) in pediatric hemophilia A patients, and of a second pivotal trial (AERIFY-2) evaluating itepekimab in chronic obstructive pulmonary disease (COPD). In the Vaccines segment, Sanofi and GSK announced the launch of their Phase III clinical study to assess the safety, efficacy, and immunogenicity of their adjuvanted recombinant-protein COVID-19 vaccine candidate. Following encouraging interim results from the recent Phase II study, the companies will also begin clinical studies to assess the ability of the adjuvanted recombinant-protein vaccine candidate to generate a strong booster response regardless of the initial vaccine platform received. The vaccine could be approved in the fourth quarter of 2021, subject to positive Phase III outcomes and regulatory reviews.
Sanofi obtained regulatory marketing approval for a number of products during the first half of 2021. In the United States, the PD-1 inhibitor Libtayo (cemiplimab-rwlc) received full approval for locally advanced basal cell carcinoma (BCC) and accelerated approval in metastatic BCC, following a priority review by the US Food and Drug Administration (FDA). Libtayo is now approved for the two most common advanced skin cancers in the United States. The European Commission also approved Libtayo for the treatment of metastatic or locally advanced BCC in adults. The FDA and the European Commission approved Libtayo for the first-line treatment of patients with advanced non-small cell lung cancer (NSCLC) whose tumors have high PD-L1 expression. The FDA and the European Commission approved Sarclisa (isatuximab-irfc), in combination with carfilzomib and dexamethasone, for adult patients with relapsed and refractory multiple myeloma who have received one to three prior therapies. The European Commission approved Aubagio (teriflunomide) for the treatment of pediatric patients aged 10 to 17 years with relapsing-remitting multiple sclerosis (MS). The approval confirms Aubagio as the first oral therapy for first-line treatment of children and adolescents with MS in the European Union.
For an update on our research and development pipeline, refer to Section F of this half-year management report.
1 Non-GAAP financial measure see definition in C.3., "Net sales".
2 Non-GAAP financial measure see definition in C.2., "Business net income".
A.3. OTHER SIGNIFICANT EVENTS
A.3.1 CORPORATE GOVERNANCE
The Annual General Meeting of Sanofi shareholders was held on April 30, 2021 behind closed doors, in accordance with exceptional measures implemented by the French authorities to adapt the rules for holding shareholder meetings in light of the COVID-19 crisis. The meeting, chaired by Serge Weinberg, took place at Sanofi's Paris headquarters. All the resolutions put to the vote were passed. The Annual General Meeting approved the individual company financial statements and the consolidated financial statements for the year ended December 31, 2020, along with the distribution of a cash dividend of 3.20 per share paid on May 7, 2021. The meeting approved the reappointment of Fabienne Lecorvaisier and Melanie Lee as directors ratified the co-opting of Gilles Schnepp as a director and approved the appointment of Barbara Lavernos to replace Laurent Attal as a director. On a proposal from the Appointments, Governance and CSR Committee, Rachel Duan was appointed as a member of the Compensation Committee Lise Kingo as a member of the Appointments, Governance and CSR Committee and Gilles Schnepp as a member of the Strategy Committee. The Board of Directors also noted the designation of Wolfgang Laux and Yann Tran as directors representing employees, replacing Marion Palme and Christian Senectaire respectively. Following the Annual General Meeting, the Board of Directors has 15 members, seven of whom are women and two of whom are employee representatives. The Board retains a substantial 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, 2020, 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
Lantus Mylan Patent Litigation (United States)
Regarding the ongoing US Patent Trial and Appeal Board (PTAB) proceedings brought by Mylan challenging the validity of certain claims of U.S. Patent Nos. 8,603,044, 8,679,069, 8,992,486, 9,526,844, and 9,604,008, in May 2021, Mylan's cross appeal concerning U.S. Patent No. 9,604,008 was dismissed by the US Court of Appeals for the Federal Circuit (CAFC).
Regarding the ongoing PTAB proceedings brought by Mylan challenging the validity of the claims of U.S. Patent No. RE47,614, in March 2021, the PTAB issued a written decision invalidating all claims of this patent. In May 2021, Sanofi appealed to the CAFC and the appeal is underway.
Cerdelga Patent Litigation (United States)
Sanofi-Genzyme has settled the case with all of the defendants (Cipla Limited Zenara Pharma Private Limited Teva Pharmaceuticals USA, Inc. Dr. Reddy's Laboratories, Ltd. Apotex Inc. Aizant Drug Research Solutions Private Limited). The case is closed.
In September 2019, Sanofi US received a Civil Investigative Demand (CID) from the US Department of Justice concerning Dupixent , Kevzara , Praluent and Zaltrap . In June 2021, the government declined to intervene in the underlying complaint which was filed in November 2018, and unsealed upon the government declination. The Relators who filed the complaint have until September 1, 2021 to serve the complaint on Regeneron and Sanofi, if they choose to proceed. The government investigation into this matter is now closed.
Insulin related litigation (United States)
In In re Direct Purchaser Insulin Pricing Litigation, in July 2021, the court issued an order dismissing the antitrust claims against defendants, but allowing the claims under the federal Racketeer Influenced and Corrupt Organizations Act to proceed.
There are two new insulin related litigation matters filed against Sanofi US or its affiliates (and other defendants) regarding the pricing of Lantus , Apidra , and Toujeo . The two lawsuits allege some combination of violations of state unfair deceptive trade practices statutes, violations of antitrust laws, unjust enrichment, common-law fraud, and civil conspiracy. The status of these matters is as follows.
Mississippi vs. Sanofi Aventis US LLC et al (Mississippi Chancery Court of Hinds County, filed June 7, 2021)
Sanofi US has not yet been served with the complaint.
Miami, Florida vs. Sanofi US Services, Inc. et al (State Court in Miami-Dade County, filed June 16, 2021)
Sanofi US Services, Inc. was served with the complaint on July 8, 2021.
On June 7, 2021, Sanofi launched "Action 2021", a global employee stock ownership plan open to 92,000 employees across 73 countries. This new plan, in line with similar plans implemented since 2013, clearly demonstrates the ongoing commitment of Sanofi and its Board of Directors to involve all employees, across all geographies, in the company's future development and results.
The shares were offered at a subscription price of 69.38, representing a 20% discount to the average of the 20 opening prices of Sanofi shares from May 6 through June 2, 2021. In addition, for every five shares subscribed, employees are entitled to receive one free share (up to a maximum of four free shares per employee). Finally, each employee is able to subscribe for up to 1,500 Sanofi shares subject to a statutory cap on the amount subscribed, 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 2021.
On July 13, 2021, Sanofi announced becoming a Premium Partner of Paris 2024 for the Olympic and Paralympic Games being held in Paris in 2024. For Sanofi, whose headquarters are based in Paris, this commitment to Paris 2024 is a unique opportunity to engage its 100,000 employees in one of the largest sporting events in the world. Sanofi's commitment to Paris 2024 also highlights the company's societal impact strategy and affirms its commitment to the values of inclusion, diversity and openness to the world, as well as its environmental ambition. The company welcomes the desire of Paris 2024 to foster the values of the Games to increase their accessibility to the public and make them more sustainable and intends to contribute by highlighting the benefits of physical activity on health.
On July 29, 2021, Sanofi announced that a pivotal Phase 3 trial evaluating Dupixent (dupilumab) in patients with moderate-to-severe chronic spontaneous urticaria (CSU), an inflammatory skin disease, met its primary endpoints and all key secondary endpoints at 24 weeks. Adding Dupixent to standard-of-care antihistamines significantly reduced itch and hives for biologic-na ve patients, compared to those treated with antihistamines alone (placebo) in Study A (the first of two trials) of the LIBERTY CUPID clinical program.
On July 29, 2021, Sanofi announced that Karen Linehan and Philippe Luscan, who have led Legal, Ethics Business Integrity (LEBI) and Industrial Affairs at Sanofi for the last 14 and 13 years respectively have decided to retire. Karen will retire on December 31, 2021 and Philippe later in 2022. Sanofi has appointed Roy Papatheodorou and Brendan O'Callaghan as their respective replacements, joining the company's Executive Committee. Additionally, Viviane Monges will join EUROAPI, a future leading European company dedicated to the development, production, and marketing of active pharmaceutical ingredients (API), as an independent non-executive Chair of the Supervisory Board. She will serve as Chair of the Board of Directors upon transformation of EUROAPI into a soci t anonyme, in compliance with applicable corporate governance regulations. Together, these appointments underscore the company's strategy to further increase the diversity and cultural backgrounds of the executives leading Sanofi's modernization.
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, 2020 and June 30, 2021
( million) June 30, 2021 (6 months) as % of net sales June 30, 2020 (6 months) as % of net sales
Net sales 17,335 100.0 % 17,180 100.0 %
Other revenues 596 3.4 % 574 3.3 %
Cost of sales (5,541) (32.0) % (5,543) (32.3) %
Gross profit 12,390 71.5 % 12,211 71.1 %
Research and development expenses (2,663) (15.4) % (2,692) (15.7) %
Selling and general expenses (4,530) (26.1) % (4,607) (26.8) %
Other operating income 409 281
Other operating expenses (709) (693)
Amortization of intangible assets (775) (883)
Impairment of intangible assets (178) (323)
Fair value remeasurement of contingent consideration (4) 54
Restructuring costs and similar items (327) (758)
Other gains and losses, and litigation - 136
Gain on Regeneron investment arising from transaction of May 29, 2020 - 7,382
Operating income 3,613 20.8 % 10,108 58.8 %
Financial expenses (189) (198)
Financial income 28 31
Income before tax and investments accounted for using the equity method 3,452 19.9 % 9,941 57.9 %
Income tax expense (682) (994)
Share of profit (loss) from investments accounted for using the equity method 26 354
Net income 2,796 16.1 % 9,301 54.1 %
Net income attributable to non-controlling interests 20 20
Net income attributable to equity holders of Sanofi 2,776 16.0 % 9,281 54.0 %
Average number of shares outstanding (million) 1,250.3 1,251.7
Average number of shares after dilution (million) 1,255.6 1,258.2
Basic earnings per share (in euros) 2.22 7.41
Diluted earnings per share (in euros) 2.21 7.38
C.1. SEGMENT INFORMATION
C.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.
Sanofi has three operating segments Pharmaceuticals, Vaccines, and Consumer Healthcare.
The Pharmaceuticals segment comprises, for all geographical territories, the commercial operations of the following global franchises Specialty Care (Dupixent , Neurology Immunology, Rare Diseases, Oncology, and Rare Blood Disorders) and General Medicines (Diabetes, Cardiovascular, and Established Prescription Products), together with research, development and production activities dedicated to the Pharmaceuticals segment. This segment also includes associates whose activities are related to pharmaceuticals. Following the transaction of May 29, 2020, Regeneron is no longer an associate of Sanofi (see Note D.1. to our consolidated financial statements for the year ended December 31, 2020). Consequently, the Pharmaceuticals segment no longer includes Sanofi's equity-accounted share of Regeneron's profits for all the periods presented in that note.
The Vaccines segment comprises, for all geographical territories, the commercial operations of Sanofi Pasteur, together with research, development and production activities dedicated to vaccines.
The Consumer Healthcare segment comprises, for all geographical territories, the commercial operations for Sanofi's Consumer Healthcare products, together with research, development and production activities dedicated to those products.
Inter-segment transactions are not material.
The costs of Sanofi's global support functions (External Affairs, Finance, Human Resources, Legal Affairs, Information Solutions Technologies, Sanofi Business Services, etc.) are mainly managed centrally at group-wide level. The costs of those functions are presented within the "Other" category. That category also includes other reconciling items such as retained commitments in respect of divested activities.
Following the Capital Markets Day held in February 2021, Sanofi changed the presentation of net sales for certain products in the Pharmaceuticals segment (within the General Medicines GBU) and the Consumer Healthcare segment, and also reallocated certain expenses. In particular, IT costs relating to our new digital organization - previously allocated to the Pharmaceutical, Vaccines, and Consumer Healthcare segments - are now included within the "Other" segment. The 2020 segmental results presented below have been amended for comparative purposes in order to reflect those adjustments.
We report segment results on the basis of "Business operating income". This indicator is used internally by Sanofi's chief operating decision maker to measure the performance of each operating segment and to allocate resources. For a definition of "Business operating income", and a reconciliation between that indicator and Income before tax and investments accounted for using the equity method, refer to Note B.20.1.2. to our condensed half-year consolidated financial statements.
In the first half of 2021, "Business operating income" amounted to 4,903 million (versus 4,683 million for the first half of 2020), while "Business operating income margin" was 28.3% (versus 27.3% for the first half of 2020). "Business operating income margin" is a non-GAAP financial measure that we define as the ratio of "Business net income" to our consolidated net sales.
Because our "Business operating income" and "Business operating income margin" are not standardized measures, they may not be directly comparable with the non-GAAP financial measures of other companies using the same or similar non-GAAP financial measures. Despite the use of non-GAAP measures by management in setting goals and measuring performance, these are non-GAAP measures that have no standardized meaning prescribed by IFRS.
We believe that understanding of our operational performance by our management and our investors is enhanced by reporting "Business net income". This non-GAAP financial measure represents "Business operating income", less net financial expenses and the relevant income tax effects.
"Business net income" for the first half of 2021 amounted to 3,748 million, 6.4% more than in the first half of 2020 ( 3,521 million). That represents 21.6% of net sales, versus 20.5% for the first half of 2020.
We also report "Business earnings per share" (business EPS), a non-GAAP financial measure which we define as business net income divided by the weighted average number of shares outstanding.
Business EPS was 3.00 for the first half of 2021, 6.8% higher than the 2020 first-half figure of 2.81, based on an average number of shares outstanding of 1,250.3 million for the first half of 2021 and 1,251.7 million for the first half of 2020.
The table below reconciles our "Business operating income" to our "Business net income"
( million) June 30, 2021 (6 months) June 30, 2020 (6 months) December 31, 2020 (12 months)
Business operating income 4,903 4,683 9,762
Financial income and expenses (161) (167) (337)
Income tax expense (994) (995) (2,078)
Business net income 3,748 3,521 7,347
We define "Business net income" as Net income attributable to equity holders of Sanofi determined under IFRS, excluding the following items
amortization and impairment losses charged against intangible assets (other than software and other rights of an industrial or operational nature)
fair value remeasurements of contingent consideration relating to business combinations or divestments
other impacts associated with acquisitions (including impacts of acquisitions on investments accounted for using the equity method)
restructuring costs and similar items (presented within the line item Restructuring costs and similar items)
other gains and losses, including gains and losses on major disposals of non-current assets (presented within the line item Other gains and losses, and litigation)
for 2020, the gain on the divestment of Regeneron shares dated May 29, 2020 (not including the gain on the remeasurement of the 400,000 retained shares at market value as of that date)
other costs and provisions related to litigation (presented within the line item Other gains and losses, and litigation)
the tax effects of the items listed above, and the impact of major tax disputes
for 2020, the effects of the discontinuation of accounting by the equity method for the investment in Regeneron (see Note D.1. to our consolidated financial statements for the year ended December 31, 2020 and
the portion attributable to non-controlling interests of the items listed above.
The table below reconciles our "Business net income" to Net income attributable to equity holders of Sanofi
( million) June 30, 2021 (6 months) June 30, 2020 (6 months) December 31, 2020 (12 months)
Net income attributable to equity holders of Sanofi 2,776 9,281 12,314
Amortization of intangible assets (a) 775 883 1,681
Impairment of intangible assets (b) 178 323 330
Fair value remeasurement of contingent consideration 4 (54) (124)
Expenses arising from the impact of acquisitions on inventories - 36 53
Restructuring costs and similar items 327 758 1,064
Other gains and losses, and litigation (c) - (136) (136)
Gain on divestment of Regeneron shares on May 29, 2020 (d) - (7,225) (7,225)
Tax effects of the items listed above (311) (1) (264)
amortization and impairment of intangible assets (230) (302) (541)
fair value remeasurement of contingent consideration 3 2 39
expenses arising from the impact of acquisitions on inventories - (5) (8)
tax effects of restructuring costs and similar items (84) (232) (293)
gain on divestment of Regeneron shares on May 29, 2020 - 475 477
other tax effects - 61 62
Share of items listed above attributable to non-controlling interests (1) (1) (3)
Investments accounted for using the equity method restructuring costs and expenses arising from the impact of acquisitions - (30) (30)
Effect of discontinuation of equity method for investment in Regeneron (e) - (313) (313)
Business net income 3,748 3,521 7,347
Average number of shares outstanding (million) 1,250.3 1,251.7 1,253.6
Basic earnings per share (in euros) 2.22 7.41 9.82
Reconciling items per share (in euros) 0.78 (4.60) (3.96)
Business earnings per share (in euros) 3.00 2.81 5.86
(a)Includes amortization expense related to accounting for business combinations 729 million in the six months ended June 30, 2021 839 million in the six months ended June 30, 2020 and 1,592 million in the year ended December 31, 2020.
(b)This line mainly includes impairment losses related to in-house and partnered R D programs within the Specialty Care and Vaccines GBUs, and for the six months ended June 30, 2020 to the discontinuation of certain R D programs and collaboration agreements in Diabetes in line with the strategy announced by Sanofi in December 2019.
(c)For the six months ended June 30, 2020, this line mainly comprises the gain on the sale of operations related to the Seprafilm product to Baxter.
(d)This line includes, for the six months ended June 30, 2020, the gain on the sale of (i) 13 million shares of Regeneron common stock in the registered public offering and (ii) the 9.8 million shares repurchased by Regeneron, but does not include the gain arising from the remeasurement of the 400,000 retained shares at market value as of May 29, 2020.
(e)"Business net income" no longer includes Sanofi's share of profits from its equity investment in Regeneron (see Note D.1. to our consolidated financial statements for the year ended December 31, 2020), which is reflected on this line.
The most significant reconciling items between "Business net income" and Net income attributable to equity holders of Sanofi relate to (i) the purchase accounting effects of our acquisitions and business combinations, particularly the amortization and impairment of intangible assets (other than software and other rights of an industrial or operational nature) and (ii) the impacts of restructurings or transactions regarded as non-recurring, where the amounts involved are particularly significant. We believe that excluding those impacts enhances an investor's understanding of our underlying economic performance, because it gives a better representation of our recurring operating performance.
We believe that eliminating charges related to the purchase accounting effect of our acquisitions and business combinations (particularly amortization and impairment of some intangible assets) enhances comparability of our ongoing operating performance relative to our peers. Those intangible assets (principally rights relating to research, development and commercialization of products) are accounted for in accordance with IFRS 3 (Business Combinations) and hence may be subject to remeasurement. Such remeasurements are not made other than in a business combination.
We also believe that eliminating the other effects of business combinations (such as the incremental cost of sales arising from the workdown of acquired inventories remeasured at fair value in business combinations) gives a better understanding of our recurring operating performance.
Eliminating restructuring costs and similar items enhances comparability with our peers because those costs are incurred in connection with reorganization and transformation processes intended to optimize our operations.
Finally, we believe that eliminating the effects of transactions that we regard as non-recurring and that involve particularly significant amounts (such as major gains and losses on disposals, and costs and provisions associated with major litigation and other major non-recurring items) improves comparability from one period to the next.
We remind investors, however, that "Business net income" should not be considered in isolation from, or as a substitute for, Net income attributable to equity holders of Sanofi reported in accordance with IFRS. In addition, we strongly encourage investors and potential investors not to rely on any single financial measure but to review our financial statements, including the notes thereto, carefully and in their entirety.
We compensate for the material limitations described above by using "Business net income" only to supplement our IFRS financial reporting and by ensuring that our disclosures provide sufficient information for a full understanding of all adjustments included in "Business net income".
Because our "Business net income" and "Business EPS" are not standardized measures, they may not be directly comparable with the non-GAAP financial measures of other companies using the same or similar non-GAAP financial measures.
Net sales for the first half of 2021 amounted to 17,335 million, 0.9% higher than in the first half of 2020. Exchange rate fluctuations had a negative effect of 6.3 percentage points overall, due mainly to adverse trends in the euro exchange rate against the US dollar, Brazilian real and Japanese yen. At constant exchange rates (CER, see definition below), net sales rose by 7.2%, driven mainly by strong performances for Dupixent . The year-on-year increase also reflects good performances by the Rare Diseases and Oncology franchises, and also from Vaccines as sales of Meningitis Vaccines picked up strongly relative to 2020. Sales of Consumer Healthcare products were up slightly year-on-year, with robust growth for the Digestive Wellness category more than offsetting lower sales in the Cough, Cold and Flu category.
Reconciliation of net sales to net sales at constant exchange rates
( million) June 30, 2021 (6 months) June 30, 2020 (6 months) Change
Net sales 17,335 17,180 +0.9 %
Effect of exchange rates 1,075
Net sales at constant exchange rates 18,410 17,180 +7.2 %
When we refer to changes in our net sales at constant exchange rates (CER), that means that we have excluded the effect of exchange rates by recalculating net sales for the relevant period using the exchange rates that were used for the previous period.
When we refer to changes in our net sales on a constant structure (CS) basis, that means that we eliminate the effect of changes in structure by restating the net sales for the previous period as follows
by including sales generated by entities or product rights acquired in the current period for a portion of the previous period equal to the portion of the current period during which we owned them, based on historical sales information we receive from the party from whom we make the acquisition
similarly, by excluding sales for a portion of the previous period when we have sold an entity or rights to a product in the current period and
for a change in consolidation method, by recalculating the previous period on the basis of the method used for the current period.
To facilitate analysis and comparisons with prior periods, some figures are given at constant exchange rates and on a constant structure basis (CER CS).
Our net sales comprise the net sales generated by our Pharmaceuticals, Vaccines and Consumer Healthcare segments. The table below also presents net sales by Global Business Unit (GBU).
( million) June 30, 2021 (6 months) June 30, 2020 (6 months) Change on a reported basis Change at constant exchange rates
Specialty Care GBU 5,978 5,402 +10.7 % +18.7 %
General Medicines GBU 7,218 7,618 -5.3 % -0.1 %
Pharmaceuticals segment 13,196 13,020 +1.4 % +7.7 %
Vaccines GBU segment 1,937 1,836 +5.5 % +10.8 %
Consumer Healthcare GBU segment 2,202 2,324 -5.2 % +1.2 %
Total net sales 17,335 17,180 +0.9 % +7.2 %
Last updated: Jul 29, 2021