Recent Updates
Recently added Catalysts
SNY

Table of Contents HALF-YEAR MANAGEMENT REPORT (Operating and Financial Review and Prospects) 1 A/ Significant events of the first half of 2021 1 B/ Events subsequent to

Key Takeaway: HALF-YEAR MANAGEMENT REPORT (Operating and Financial Review and Prospects) 1 A/ Significant events of the first half of 2021 1 B/ Events subsequent to June 30, 2021 4 C/ Consolidated financial statements for the first half of 2021 5 D/ Risk factors and related party t

Full Press Release Details

HALF-YEAR MANAGEMENT REPORT (Operating and Financial Review and Prospects) 1
A/ Significant events of the first half of 2021 1
B/ Events subsequent to June 30, 2021 4
C/ Consolidated financial statements for the first half of 2021 5
D/ Risk factors and related party transactions 23
HALF-YEAR MANAGEMENT REPORT (Operating and Financial Review and Prospects)
A/ SIGNIFICANT EVENTS OF THE FIRST HALF OF 2021
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.
A.2. RESEARCH AND DEVELOPMENT
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.
A.3. OTHER SIGNIFICANT EVENTS
A.3.1 CORPORATE GOVERNANCE
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.
A.3.2. LEGAL AND ARBITRATION PROCEEDINGS
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
The following events have occurred in respect of litigation, arbitration and other legal proceedings in which Sanofi and its affiliates are
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.
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.
GOVERNMENT INVESTIGATIONS AND RELATED LITIGATION
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
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.
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.
B/ EVENTS SUBSEQUENT TO JUNE 30, 2021
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.
Last updated: Jul 30, 2021