UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

 

 

FORM 6-K

 

 

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

For the month of February 2020

Commission File Number: 001-31368

 

 

SANOFI

(Translation of registrant’s name into English)

 

 

54, rue La Boétie, 75008 Paris, FRANCE

(Address of principal executive offices)

 

 

Indicate by check mark whether the registrant files or will file annual reports under cover Form 20-F or Form 40-F.

Form 20-F  ☒            Form 40-F  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  ☐

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  ☐

Indicate by check mark whether the registrant by furnishing the information contained in this Form is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.

Yes  ☐            No  ☒

If “Yes” marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82-            

 

 

 


In February 2020, Sanofi issued the press releases attached hereto as Exhibit 99.1 and 99,2 which are incorporated herein by reference.

Exhibit List

 

Exhibit No.

  

Description

Exhibit 99.1    Press release dated February 24, 2020: Sanofi to create new industry leading European company to provide active pharmaceutical ingredients (API*)
Exhibit 99.2    Press release dated February 18, 2020: Sanofi joins forces with U.S. Department of Health and Human Services to advance a novel coronavirus vaccine

 

2


Exhibit Index

 

Exhibit No.

  

Description

Exhibit 99.1    Press release dated February 24, 2020: Sanofi to create new industry leading European company to provide active pharmaceutical ingredients (API*)
Exhibit 99.2    Press release dated February 18, 2020: Sanofi joins forces with U.S. Department of Health and Human Services to advance a novel coronavirus vaccine

 

3


SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

 

Dated: February 25, 2020      

SANOFI

    By   /s/ Alexandra Roger                                                 
    Name:   Alexandra Roger
    Title:   Head of Securities Law and Capital Markets

 

4

Exhibit 99.1

 

LOGO   

Press Release

Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY)

Sanofi to create new industry leading European company to provide active pharmaceutical ingredients (API*)

 

  *

New major API company1 would secure significant API manufacturing and supply capacities that are critical for patients in Europe and beyond

 

  *

The new industry champion would rank #22 globally, with approximately €1 billion in expected sales by 2022

 

  *

Headquarters to be located in France and intent for an IPO on Euronext Paris would be evaluated for an anticipated decision by 2022, subject to market conditions

Paris - February 24, 2020 – Sanofi plans to create a major leading European company dedicated to the production and marketing to third parties of active pharmaceutical ingredients (API), which are the essential molecules responsible for the beneficial effects used in the composition of any drug. The project consists of creating a standalone company which would combine Sanofi’s API commercial and development activities with six of its European API production sites : Brindisi (Italy), Frankfurt Chemistry (Germany), Haverhill (UK), St Aubin les Elbeuf (France), Újpest (Hungary) and Vertolaye (France).

With increasing medicine shortages that critically impact patient care, the new entity would contribute to supporting and securing API manufacturing as well as supply capacities for Europe and beyond. In Europe, the new API industry champion is expected to help in balancing the industry’s heavy reliance on API sourced from the Asian region3.

The new company would rank as the world’s second largest API company with approximately €1 billion in expected sales by 2022. It is expected to include 3,100 skilled employees and to be headquartered in France. A planned IPO on Euronext Paris would be evaluated with a decision expected by 2022, subject to market conditions.

Philippe Luscan, Executive Vice President, Global Industrial Affairs at Sanofi, said “Based on the expertise and experience built over decades within our industrial network, this new entity would help ensure a greater stability in supplying drugs to millions of patients in Europe and beyond. With this endeavor, this new entity would be agile as a standalone company, and able to unlock its growth potential, especially in capturing new third-party sales and all the opportunities of a market growing at a pace of 6 % per year4.”

 

1 

Subject to consultation with social partners and works councils.

2 

Source : Company estimates based on comparison with data published in annual reports of major API companies

3 

CPA Industry Report 2019: 60% of the API worldwide production in volume is located in China and India.

4 

Source : Future growth estimate based on expert interviews and Technavio Report “Active Pharmaceutical Ingredients Market by Manufacturing Type and Geography – Forecast and Analysis 2020-2024”, Dec. 2019.


By operating independently, the new entity plans to increase its sales to third parties and to expand its partnerships with other pharmaceutical companies in order to take advantage of new growth opportunities and have the ability to deftly adapt to customer needs. The new company would be uniquely positioned to benefit from its significant competitive strengths, including a broad portfolio of both volume and niche products, high standards of quality, competitive pricing, state-of-the-art industrial capabilities and technologies across Europe (including France, Italy, Germany, Hungary, and the United Kingdom) as well as leveraging an extensive commercial network covering more than 80 countries.

Sanofi is fully committed to the new company’s success and intends to establish a long-term customer relationship with the new API supplier and to hold a minority stake of approximately 30% in the new company. To provide the optimal conditions for success, Sanofi intends the new company to be debt free in order to maximize its future investment capacities, and is committed to remaining an important customer.

*About Active Pharmaceutical Ingredients (API):

Active pharmaceutical ingredients or APIs are the chemicals or biologicals which have a beneficial therapeutic effect in a medicine. These are the essential molecules used in the composition and the production of any drug.

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

 

Media Relations Contact

 

Quentin Vivant

Tel.: +33 (0)1 53 77 46 46

mr@sanofi.com

  

Investor Relations Contact

 

Félix Lauscher

Tel.: +33 (0)1 53 77 45 45

ir@sanofi.com


Sanofi Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans”, “ambitions”, and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, Sanofi’s ability to complete related transactions and/or obtain regulatory clearances, on the contemplated terms and timeline, volatile economic conditions, market conditions, as well as risks discussed or identified in the public filings with the U.S. Securities and Exchange Commission and the French Autorité des marchés financiers made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2018. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Exhibit 99.2

 

LOGO

 

Press Release

Source: Sanofi (EURONEXT: SAN) (NASDAQ: SNY)

Sanofi joins forces with U.S. Department of Health and Human Services to advance a novel coronavirus vaccine

 

  *

Work with Biomedical Advanced Research and Development Authority (BARDA) will utilize Sanofi’s well-established recombinant technology platform to expedite a potential COVID-19 vaccine

PARIS – February 18, 2020 – Sanofi Pasteur, the vaccines global business unit of Sanofi, will leverage previous development work for a SARS vaccine which may unlock a fast path forward for developing a COVID-19 vaccine. Sanofi will collaborate with the Biomedical Advanced Research and Development Authority (BARDA), part of the Office of the Assistant Secretary for Preparedness and Response, expanding the company’s long-standing partnership with BARDA.

COVID-19 belongs to a family of coronaviruses that can cause respiratory disease. In late 2002, the SARS (severe acute respiratory syndrome) coronavirus emerged and then largely disappeared by 2004. Sanofi plans to further investigate an advanced pre-clinical SARS vaccine candidate that could protect against COVID-19.

“Addressing a global health threat such as this newest coronavirus is going to take a collaborative effort, which is why we are working with BARDA to quickly advance a potential vaccine candidate,” said David Loew, Global Head of Vaccines at Sanofi. “While we are lending our expertise where possible, we believe the collaboration with BARDA may provide the most meaningful results in protecting the public from this latest outbreak.”

Sanofi to utilize innovative recombinant technology platform

Sanofi will use its recombinant DNA platform to produce a 2019 novel coronavirus vaccine candidate. The recombinant technology produces an exact genetic match to proteins found on the surface of the virus. The DNA sequence encoding this antigen will be combined into the DNA of the baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product, and used to rapidly produce large quantities of the coronavirus antigen which will be formulated to stimulate the immune system to protect against the virus.

“Emerging global health threats like the 2019 novel coronavirus require a rapid response,” said BARDA Director Rick A. Bright, Ph.D. “By expanding our partnership with Sanofi Pasteur and leveraging a licensed recombinant vaccine platform, we hope to speed development of a vaccine candidate to protect against a new virus.”


Sanofi uniquely positioned in search for a coronavirus vaccine

In non-clinical studies, the SARS vaccine candidate was immunogenic and afforded partial protection as assessed in animal challenge models. This development work by Protein Sciences (acquired by Sanofi in 2017) provides a head start in expediting a COVID-19 vaccine. Additionally, since there is a licensed vaccine based on this platform this will allow for research and materials to be produced relatively quickly for clinical testing. Sanofi’s platform also has the potential to manufacture large quantities of the vaccine candidate.

Sanofi’s long-standing commitment to protecting public health

This agreement with BARDA marks another milestone in Sanofi’s ongoing contributions to help fight public health threats. Sanofi continues to actively explore potential opportunities where the company’s deep vaccine experience and innovative technologies may contribute to addressing the coronavirus public health situation, including sharing Sanofi’s vaccine research and development experience with the Coalition for Epidemic Preparedness Innovations.

In December 2019, Sanofi also entered into an agreement with BARDA to establish state of the art facilities in the U.S. for the sustainable production of an adjuvanted recombinant vaccine for use in the event of an influenza pandemic and based on the same technology platform that will be used for the COVID-19 program.

About Sanofi

Sanofi is dedicated to supporting people through their health challenges. We are a global biopharmaceutical company focused on human health. We prevent illness with vaccines, provide innovative treatments to fight pain and ease suffering. We stand by the few who suffer from rare diseases and the millions with long-term chronic conditions.

With more than 100,000 people in 100 countries, Sanofi is transforming scientific innovation into healthcare solutions around the globe.

Sanofi, Empowering Life

 

Media Relations Contact

 

Marion Breyer

Tel.: +33 (0)1 53 77 46 46

mr@sanofi.com

  

Investor Relations Contact

 

Felix Lauscher

Tel.: +33 (0)1 53 77 45 45

ir@sanofi.com


Forward-Looking Statements

This press release contains forward-looking statements as defined in the Private Securities Litigation Reform Act of 1995, as amended. Forward-looking statements are statements that are not historical facts. These statements include projections and estimates and their underlying assumptions, statements regarding plans, objectives, intentions and expectations with respect to future financial results, events, operations, services, product development and potential, and statements regarding future performance. Forward-looking statements are generally identified by the words “expects”, “anticipates”, “believes”, “intends”, “estimates”, “plans” and similar expressions. Although Sanofi’s management believes that the expectations reflected in such forward-looking statements are reasonable, investors are cautioned that forward-looking information and statements are subject to various risks and uncertainties, many of which are difficult to predict and generally beyond the control of Sanofi, that could cause actual results and developments to differ materially from those expressed in, or implied or projected by, the forward-looking information and statements. These risks and uncertainties include among other things, the uncertainties inherent in research and development, future clinical data and analysis, including post marketing, decisions by regulatory authorities, such as the FDA or the EMA, regarding whether and when to approve any drug, device or biological application that may be filed for any such product candidates as well as their decisions regarding labelling and other matters that could affect the availability or commercial potential of such product candidates, the absence of guarantee that the product candidates if approved will be commercially successful, the future approval and commercial success of therapeutic alternatives, Sanofi’s ability to benefit from external growth opportunities, to complete related transactions and/or obtain regulatory clearances, risks associated with intellectual property and any related pending or future litigation and the ultimate outcome of such litigation, trends in exchange rates and prevailing interest rates, volatile economic conditions, the impact of cost containment initiatives and subsequent changes thereto, the average number of shares outstanding as well as those discussed or identified in the public filings with the SEC and the AMF made by Sanofi, including those listed under “Risk Factors” and “Cautionary Statement Regarding Forward-Looking Statements” in Sanofi’s annual report on Form 20-F for the year ended December 31, 2018. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.