Sanofi (Form: 6-K, Received: 04/15/2020 10:13:23)

Dated: April 15, 2020

/s/ Alexandra Roger

Alexandra Roger

Head of Securities Law and Capital Markets

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 April 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 April 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 April 14, 2020: Sanofi and GSK to join forces in unprecedented vaccine collaboration to fight COVID-19

Exhibit 99.2		Press release dated April 10, 2020: COVID-19: Sanofi to donate 100 million doses of hydroxychloroquine across 50 countries

Exhibit Index


Exhibit No.		Description

Exhibit 99.1		Press release dated April 14, 2020: Sanofi and GSK to join forces in unprecedented vaccine collaboration to fight COVID-19

Exhibit 99.2		Press release dated April 10, 2020: COVID-19: Sanofi to donate 100 million doses of hydroxychloroquine across 50 countries

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.

Exhibit 99.1

Press Release

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

Sanofi and GSK to join forces in unprecedented vaccine collaboration to fight COVID-19

Companies to combine innovative technologies to develop an adjuvanted COVID-19 vaccine

Candidate vaccine expected to enter clinical trials in the second half of 2020 and, if successful, to be available in the second half of 2021

PARIS and LONDON – April 14, 2020 - Sanofi and GSK today announce that they have signed a letter of intent to develop an adjuvanted vaccine for COVID-19, using innovative technology from both companies, to help address the ongoing pandemic.

Sanofi will contribute its S-protein COVID-19 antigen, which is based on recombinant DNA technology. This technology has produced an exact genetic match to proteins found on the surface of the virus, and the DNA sequence encoding this antigen has been combined into the DNA of the baculovirus expression platform, the basis of Sanofi’s licensed recombinant influenza product in the US.

GSK will contribute its proven pandemic adjuvant technology. The use of an adjuvant can be of particular importance in a pandemic situation since it may reduce the amount of vaccine protein required per dose, allowing more vaccine doses to be produced and therefore contributing to protect more people.

“As the world faces this unprecedented global health crisis, it is clear that no one company can go it alone.” says Paul Hudson, Chief Executive Officer, Sanofi. “That is why Sanofi is continuing to complement its expertise and resources with our peers, such as GSK, with the goal to create and supply sufficient quantities of vaccines that will help stop this virus.”

“This collaboration brings together two of the world’s largest vaccines companies.” says Emma Walmsley, Chief Executive Officer, GSK. “By combining our scientific expertise, technologies and capabilities, we believe that we can help accelerate the global effort to develop a vaccine to protect as many people as possible from Covid-19.”

The combination of a protein-based antigen together with an adjuvant is well-established and used in a number of vaccines available today. An adjuvant is added to some vaccines to enhance the immune response and has been shown to create a stronger and longer- lasting immunity against infections than the vaccine alone. It can also improve the likelihood of delivering an effective vaccine that can be manufactured at scale.

The companies plan to initiate phase I clinical trials in the second half of 2020 and, if successful, subject to regulatory considerations, aim to complete the development required for availability by the second half of 2021.

As previously announced by Sanofi, development of the recombinant-based COVID-19 vaccine candidate is being supported through funding and a collaboration with the Biomedical Advanced Research and Development Authority (BARDA), part of the office of the Assistant Secretary for Preparedness and Response at the U.S. Department of Health and Human Services. The companies plan to discuss funding support with other governments and global institutions prioritising global access.

“Strategic alliances among vaccine industry leaders are essential to make a coronavirus vaccine available as soon as possible,” says BARDA Director, Rick A. Bright, Ph.D. “Development of the adjuvanted recombinant-based COVID-19 vaccine candidate holds the potential to lower the vaccine dose to provide vaccine to a greater number of people to end this pandemic, and help the world become better prepared or even prevent future coronavirus outbreaks.”

The companies have set up a Joint Task Force, co-chaired by David Loew, Global Head of Vaccines, Sanofi and Roger Connor, President Vaccines, GSK. The taskforce will seek to mobilize resources from both companies to look for every opportunity to accelerate the development of the candidate vaccine.

Considering the extraordinary humanitarian and financial challenge of the pandemic, both companies believe that global access to COVID-19 vaccines is a priority and are committed to making any vaccine that is developed through the collaboration affordable to the public and through mechanisms that offer fair access for people in all countries.

These efforts mark a significant milestone in Sanofi’s and GSK’s ongoing contributions to help fight COVID-19. The companies have entered into a Material Transfer Agreement to enable them to start working together immediately. Definitive terms of the collaboration are expected to be finalised over the next few weeks.

About GSK

GSK is a science-led global healthcare company with a special purpose: to help people do more, feel better, live longer. GSK is the leading manufacturer of vaccines globally. For further information please visit www.gsk.com

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

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” 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 fact that product candidates if approved may not 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 and market conditions, the impact of global disruptions, including pandemics, 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, 2019. 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

Press Release

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

COVID-19: Sanofi to donate 100 million doses of hydroxychloroquine across 50 countries

Sanofi to provide Plaquenil^® (hydroxychloroquine) wherever possible, while securing appropriate supply levels for current approved indications;

The company already increased its production capacity by 50% and is on track to further increase production over the coming months;

Ongoing global clinical studies are assessing the efficacy and safety of hydroxychloroquine in the treatment of COVID-19;

If the ongoing clinical studies demonstrate its safety and efficacy in COVID-19 patients, Sanofi commits to donating the medicine to governments worldwide;

Sanofi CEO calls for greater international cooperation among the entire hydroxychloroquine chain, if proven safe and effective in COVID-19.

Paris – April 10, 2020 – As of today, Sanofi has committed to donating 100 million doses of hydroxychloroquine to 50 countries around the world, and has begun to progressively deliver the medicine to authorities that have requested it.

Hydroxychloroquine donation

In this global health emergency, Sanofi stands ready to assist as many countries as possible, starting with countries where its medicine is registered for current approved indications as well as countries where there are no hydroxychloroquine suppliers or countries with underserved populations.

Since the beginning of the COVID-19 crisis, Sanofi has received a growing number of requests from local governments around the world. The company is regularly evaluating its increasing supply capacity and re-assessing how best to help those countries in the most ethical way. Sanofi’s priority is to ensure supply continuity for patients treated under the current approved indications of the medicine, notably including lupus and rheumatoid arthritis, while working hard to supply governments wishing to increase stocks in the hope that it may be an effective treatment of COVID-19.

Sanofi will continue to donate the medicine to governments and hospital institutions if ongoing clinical studies demonstrate its efficacy and safety in COVID-19 patients.

Production capacity ramp up

Sanofi has already doubled its incremental production capacity (on top of the usual production for current indications) across its eight hydroxychloroquine manufacturing sites worldwide and is on track to quadruple it by the summer.

Call for greater international cooperation

Sanofi is calling for coordination among the entire hydroxychloroquine chain worldwide to ensure the continued supply of the medicine if proven to be a well-tolerated and effective treatment in COVID-19 patients.

“The COVID-19 pandemic is an unprecedented health and economic crisis which is shaking some of the very fundamentals of international solidarity and cooperation among countries”, says Paul Hudson, Chief Executive Officer at Sanofi. “This virus does not care about the concept of borders, so we shouldn’t either. It is critical that international authorities, local governments, manufacturers, and all the other players involved in the hydroxychloroquine chain work together in a coordinated manner to ensure all patients who may benefit from this potential treatment can access it. If the trials prove positive, we hope our donation will play a critical role for patients.”

The company is already actively working with different stakeholders at local and international levels, and is ready to play its part in contributing to a more coordinated global initiative.

Ensure patient safety

At this point, the interpretations of the available preliminary data on hydroxychloroquine in the management of COVID-19 differ widely. In this context, patient safety must always be the guiding principle.

Hydroxychloroquine has several serious known side effects and should be used with caution. Not everyone can take this medicine.

To date, there is insufficient clinical evidence to draw any conclusion over the safety and efficacy of hydroxychloroquine in the management of COVID-19 patients. It is one of several medicines being investigated by the World Health Organization (WHO) in its international clinical trial seeking a treatment solution for COVID-19. Sanofi is supporting ongoing trials by providing the medicine to some participating investigator sites and other independent research centers.

While hydroxychloroquine is generating a lot of hope for patients around the world, it should be remembered that there are no results from ongoing studies, and the results may be positive or negative.

Sanofi’s efforts in the fight against COVID-19

Sanofi remains at the forefront of initiatives to fight the coronavirus, while also carrying on the daily business of making and delivering important medicines for patients. The company is also exploring alternative treatment options such as Kevzara^® (sarilumab) for severe COVID-19 patients, and leveraging its expertise to develop a new vaccine. Both measures could have an immediate and a lasting impact. Dealing with a pandemic as daunting as COVID-19 requires collaboration to create as many paths forward as possible, and Sanofi is helping lead the way, playing its part.