CAUTIONARY STATEMENT REGARDING FORWARD-LOOKING STATEMENTS
This prospectus supplement and the attached prospectus, including the documents incorporated herein by reference, contain forward looking
statements (within the meaning of Section 27A of the U.S. Securities Act of 1933 (the Securities Act) or Section 21E of the U.S. Securities Exchange Act of 1934 (the Exchange Act)) about us, including without
limitation, certain statements made in Item 5. Operating and financial review and prospects, as well as in Item 4.B. Business overview of our 2017 Annual Report on Form
20-F,
as defined
herein.
Examples of such forward looking statements include:
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projections of operating revenues, net income, business net income, earnings per share, business earnings per share, capital expenditures, cost savings, restructuring costs, positive or negative synergies, dividends,
capital structure or other financial items or ratios;
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statements of our profit forecasts, trends, plans, objectives or goals, including those relating to products, clinical trials, regulatory approvals and competition; and
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statements about our future events and economic performance or that of France, the United States or any other countries in which we operate.
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This information is based on data, assumptions and estimates considered as reasonable by Sanofi as at the date of this prospectus supplement
and undue reliance should not be placed on such statements.
Words such as believe, anticipate, plan,
expect, intend, target, estimate, project, predict, forecast, guideline, should and similar expressions are intended to identify forward
looking statements but are not the exclusive means of identifying such statements.
Forward looking statements involve inherent, known and
unknown, risks and uncertainties associated with the regulatory, economic, financial and competitive environment, and other factors that could cause future results and objectives to differ materially from those expressed or implied in the forward
looking statements. Such risk factors, some of which are discussed under Item 3. Key Information D. Risk Factors of our 2017 Form
20-F
(as defined herein), include but are not limited to the
following:
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we rely on our patents and other proprietary rights to provide exclusive rights to market certain of our products, and if such patents and other rights were limited, invalidated or circumvented, our financial results
could be materially and adversely affected;
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product liability claims could adversely affect our business, results of operations and financial condition;
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our products and manufacturing facilities are subject to significant government regulations and approvals, which are often costly and could result in adverse consequences to our business if we fail to anticipate the
regulations, comply with them and/or maintain the required approvals;
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claims and investigations relating to compliance, competition law, marketing practices, pricing, data privacy and other legal matters, could adversely affect our business, results of operations and financial condition;
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changes in the laws or regulations that apply to us could affect our business, results of operations and financial condition;
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our research and development efforts may not succeed in adequately renewing our product portfolio;
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the pricing and reimbursement of our products is increasingly affected by decisions of governments and other third parties and cost reduction initiatives;
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the concentration of the U.S. market exposes us to greater pricing pressure;
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we may lose market share to competing therapeutic options, biosimilar or generic products;
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the manufacture of our products is technically complex, and supply interruptions, product recalls or inventory losses caused by unforeseen events may reduce sales, adversely affect our operating results and financial
condition, delay the launch of new products and negatively impact our image;
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we rely on third parties for the discovery, manufacture and marketing of some of our products;
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a substantial share of the revenue and income of Sanofi continues to depend on the performance of certain flagship products;
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we are subject to the risk of
non-payment
by our customers;
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global economic conditions and an unfavorable financial environment could have negative consequences for our business;
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counterfeit versions of our products harm our business;
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breaches of data security, disruptions of information technology systems and cyber threats could result in financial, legal, business or reputational harm;
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the expansion of social media platforms and new technologies present risks and challenges for our business and reputation;
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impairment charges or write-downs in our books and changes in accounting standards could have a significant adverse effect on Sanofis results of operations and financial results;
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our pension liabilities are affected by factors such as the performance of plan assets, interest rates, actuarial data and experience and changes in laws and regulations;
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our strategic objectives for long-term growth may not be fully realized;
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we may fail to successfully identify external business opportunities or realize the anticipated benefits from our strategic investments;
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the globalization of our business exposes us to increased risks in specific areas;
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our success depends in part on our senior management team and other key employees and our ability to attract, integrate and retain key personnel and qualified individuals in the face of intense competition;
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environmental risks of hazardous materials could adversely affect our results of operations;
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environmental risks of our industrial activities;
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risks related to natural disasters prevalent in certain regions in which we do business; and
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risks related to financial markets.
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We caution you that the foregoing list of factors is not
exclusive and a number of important factors, discussed under Item 3. Key Information D. Risk Factors of our 2017 Form
20-F
(as defined herein) could affect the future results and cause
actual results to differ materially from those contained in any forward looking statements. Additional risks, not currently known or considered immaterial by the Group, may have the same unfavorable effect and investors may lose all or part of their
investment.
Forward looking statements speak only as of the date they are made. Other than required by law, we do not undertake any
obligation to update them in light of new information or future developments.
MIFID II PRODUCT
GOVERNANCE
Solely for the purposes of each manufacturers product approval process, the target market assessment in respect of
the notes has led to the conclusion that: (i) the target market for the notes is eligible counterparties and
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professional clients only, each as defined in Directive 2014/65/EU (as amended, MiFID II); and (ii) all channels for distribution of the notes to eligible counterparties and
professional clients are appropriate. Any person subsequently offering, selling or recommending the notes (a distributor) should take into consideration the manufacturers target market assessment; however, a distributor subject to
MiFID II is responsible for undertaking its own target market assessment in respect of the notes (by either adopting or refining the manufacturers target market assessment) and determining appropriate distribution channels.
PROHIBITION OF SALES TO EEA RETAIL INVESTORS
The notes are not intended to be offered, sold or otherwise made available to and should not be offered, sold or otherwise made available to
any retail investor in the European Economic Area (the EEA). For these purposes, a retail investor means a person who is one (or more) of: (i) a retail client as defined in point (11) of Article 4(1) of MiFID II; or (ii) a
customer within the meaning of Directive 2002/92/EC (as amended, the Insurance Mediation Directive), where that customer would not qualify as a professional client as defined in point (1) of Article 4(1) of MiFID II; or
(iii) not a qualified investor as defined in Directive 2003/71/EC (as amended, the Prospectus Directive). Consequently, no key information document required by Regulation (EU) No 1286/2014 (as amended, the PRIIPs
Regulation) for offering or selling the notes or otherwise making them available to retail investors in the EEA has been prepared and therefore offering or selling the notes or otherwise making them available to any retail investor in the EEA
may be unlawful under the PRIIPs Regulation.
NOTICE TO CANADIAN RESIDENTS
No prospectus has been filed with any securities commission or similar regulatory authority in Canada in connection with the offer and sale of
the notes described herein. No securities commission or similar regulatory authority in Canada has reviewed or in any way passed upon this document or on the merits of the notes and any representation to the contrary is an offence.
Canadian investors are advised that this document has been prepared in reliance on section 3A.3 of National Instrument 33-105 Underwriting
Conflicts (NI 33-105). Pursuant to section 3A.3 of NI 33-105, this document is exempt from the requirement to provide investors with certain conflicts of interest disclosure pertaining to connected issuer and/or related
issuer relationships as would otherwise be required pursuant to subsection 2.1(1) of NI 33-105.
Resale Restrictions
The offer and sale of the notes in Canada is being made on a private placement basis only and is exempt from the requirement to prepare and
file a prospectus under applicable Canadian securities laws. Any resale of notes acquired by a Canadian investor in this offering must be made in accordance with applicable Canadian securities laws, which may vary depending on the relevant
jurisdiction, and which may require resales to be made in accordance with Canadian prospectus requirements, a statutory exemption from the prospectus requirements, in a transaction exempt from the prospectus requirements or otherwise under a
discretionary exemption from the prospectus requirements granted by the applicable local Canadian securities regulatory authority. These resale restrictions may under certain circumstances apply to resales of the notes outside of Canada.
Representations of Purchasers
Each Canadian investor who purchases the notes will be deemed to have represented to the issuer and to each dealer from whom a purchase
confirmation is received, as applicable, that the investor (i) is purchasing as principal, or is deemed to be purchasing as principal in accordance with applicable Canadian securities laws; (ii) is an accredited investor as such term is
defined in section 1.1 of National Instrument 45-106
Prospectus
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Exemptions
(NI 45-106) or, in Ontario, as such term is defined in section 73.3(1) of the
Securities Act
(Ontario); and (iii) is a permitted client as such
term is defined in section 1.1 of National Instrument 31-103
Registration Requirements, Exemptions and Ongoing Registrant Obligations.
Securities legislation in certain of the Canadian jurisdictions provides certain purchasers of securities, with a remedy for damages or
rescission, or both, in addition to any other rights they may have at law, if this prospectus (including any amendment thereto) contains a misrepresentation as defined under applicable Canadian securities laws. These remedies, or notice
with respect to these remedies, must be exercised or delivered, as the case may be, by the purchaser within the time limits prescribed under, and are subject to limitations and defenses under, applicable Canadian securities legislation. The
purchaser should refer to the applicable Canadian securities legislation or consult with a legal advisor.
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INCORPORATION OF INFORMATION WE FILE WITH THE SEC
We have filed with the U.S. Securities and Exchange Commission (the SEC) a registration statement on Form
F-3
relating to the notes covered by this prospectus supplement and the attached prospectus. This prospectus supplement and the attached prospectus are part of that registration statement and do not contain all the
information in the registration statement. Whenever a reference is made in this prospectus supplement and the attached prospectus to a contract or other document of Sanofi, the reference is only a summary. You should refer to the exhibits that are a
part of the registration statement for a copy of the contract or other document. You may review a copy of the registration statement at the SECs public reference room in Washington, D.C., as well as through the SECs Internet site
(http://www.sec.gov).
The SEC allows us to incorporate by reference the information we file with them, which means that:
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incorporated documents are considered part of this prospectus supplement and the attached prospectus;
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we can disclose important information to you by referring to those documents; and
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information that we file with the SEC in the future and incorporate by reference herein will automatically update and supersede information in this prospectus supplement and the attached prospectus and information
previously incorporated by reference herein and therein.
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The information that we incorporate by reference is an important
part of this prospectus supplement and the attached prospectus.
Each document incorporated by reference is current only as of the date of
such document, and the incorporation by reference of such documents shall not create any implication that there has been no change in our affairs since the date thereof or that the information contained therein is current as of any time subsequent
to its date. Any statement contained in such incorporated documents shall be deemed to be modified or superseded for the purpose of this prospectus supplement and the attached prospectus to the extent that a subsequent statement contained in another
document we incorporate by reference at a later date modifies or supersedes that statement. Any such statement so modified or superseded shall not be deemed, except as so modified or superseded, to constitute a part of this prospectus.
We incorporate herein by reference:
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Our Annual Report on Form
20-F
for the year ended December 31, 2017 filed with the SEC on March 7, 2018 as amended by Amendment No. 1 on Form
20-F/A,
filed with the SEC on March 16, 2018 (together, the 2017 Form
20-F)
(File
No. 001-31368);
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Exhibits 99.1, 99.2, 99.3 and 99.4 of our report on Form
6-K
furnished to the SEC on June 12, 2018 that expressly states that we incorporate it by reference in the registration
statement on Form
F-3
of which this prospectus supplement and attached prospectus are a part and that contains recent information about our business and financial performance, our ratio of earnings to fixed
charges and a statement of computation of such ratio; and
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Any document filed in the future with the SEC under Sections 13(a) and 13(c) or 15(d) of the Exchange Act after the date of this prospectus supplement and the attached prospectus and until this offering is completed.
Any report on Form
6-K
that we furnish to the SEC on or after the date of this prospectus supplement (or portions thereof) is incorporated by reference in this prospectus supplement and the attached prospectus
only to the extent that the report expressly states that we incorporate it (or such portions) by reference in this prospectus supplement and the attached prospectus and that it is not subsequently superseded.
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You may also request a copy of documents incorporated by reference at no cost, by contacting us orally or in writing at the following address
and telephone number: Investor Relations, 54, rue la Boétie, 75008 Paris, France, Tel. No.:
+33-1-53-77-45-45.
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The 2017 Form
20-F
and any other information incorporated
by reference is considered to be a part of this prospectus supplement and the attached prospectus. The information in this prospectus supplement, to the extent applicable, automatically updates and supersedes the information in the 2017 Form
20-F.
We are responsible for the information contained or incorporated by reference in this
prospectus supplement, the attached prospectus and any related free-writing prospectus we prepare or authorize. We have not, and the underwriters have not, authorized any other person to provide you with any other information, and we take no
responsibility for any other information that others may give you. We are not, and the underwriters are not, making an offer to sell these notes in any jurisdiction where the offer or sale is not permitted. You should not assume that the information
appearing in this prospectus supplement, the attached prospectus and the documents incorporated by reference herein or therein, is accurate as of any date other than the date on the front of these documents. Our business, financial condition,
results of operations and prospects may have changed since that date.
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