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 17, 2020: Sanofi to present Phase 2 detailed results of its brain-penetrant BTK inhibitor in relapsing multiple sclerosis
Exhibit 99.2    Press release dated April 16, 2020: Sanofi and Luminostics to join forces on developing breakthrough COVID-19 smartphone-based self-testing solution

 

2


Exhibit Index

 

Exhibit

    No.    

  

Description

Exhibit 99.1    Press release dated April 17, 2020: Sanofi to present Phase 2 detailed results of its brain-penetrant BTK inhibitor in relapsing multiple sclerosis
Exhibit 99.2    Press release dated April 16, 2020: Sanofi and Luminostics to join forces on developing breakthrough COVID-19 smartphone-based self-testing solution

 

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: April 20, 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 present Phase 2 detailed results of its brain-penetrant BTK inhibitor in relapsing multiple sclerosis

 

  *

Sanofi to host virtual scientific session April 23 from 8:00-9:00 am EST/ 2:00 – 3:00 pm CET

PARIS – April 17, 2020 – Sanofi will host a scientific session to present detailed data from their Phase 2b trial evaluating its investigational BTK (Bruton’s tyrosine kinase) inhibitor (SAR442168), an oral, brain-penetrant, selective small molecule. In February, the company reported that the study’s primary endpoint was met, demonstrating that the BTK inhibitor significantly reduced disease activity associated with multiple sclerosis (MS) as measured by magnetic resonance imaging.

“During these unprecedented times we remain committed to sharing results that allow us to advance the understanding of multiple sclerosis and the impact our potential brain-penetrant BTK inhibitor could have on the lives of people living with this disease,” said John C. Reed, M.D. Ph.D. Sanofi’s Global Head of Research & Development. “Our virtual session will provide the opportunity for an important scientific exchange and a forum for sharing the recent clinical results obtained with our brain-penetrant BTK inhibitor for multiple sclerosis.”

Sanofi is hosting this scientific session as a result of the cancellation of the live American Academy of Neurology (AAN) annual meeting due to the COVID-19 pandemic. The virtual scientific session will be held on April 23 from 8:00-9:00am EST/2:00-3:00pm CET; to register, click here. No pre-registration available for the event.

Audio webcast and conference call will be open to healthcare professionals and healthcare media. It will include presentations followed by Q&A session and live access to the speakers including: Daniel Reich, MD, PhD, Senior Investigator at NIH and Chief of the Translational Neuroradiology Section in the National Institute of Neurological Disorders and Stroke; Ross Gruber, PhD, Principal Scientist at Sanofi Genzyme; and Anthony Traboulsee, MD, Professor and Research Chair of the MS Society of Canada at the University of British Columbia in Vancouver, Canada

Topics to be highlighted which were planned to be presented at AAN:

 

   

BTK inhibitor mechanism of action and preclinical data

 

   

Phase 2b trial design

 

   

Phase 2b efficacy and safety results


In the US and Europe, there are approximately 1.2 million people diagnosed with MS, an unpredictable, chronic disease that attacks the central nervous system. Despite current treatments, many people with MS continue to accumulate disability, and one in four suffer from progressive forms of the disease with limited or no treatments available.

The efficacy and safety of Sanofi’s BTK inhibitor has not been confirmed by any regulatory authority.

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

Ashleigh Koss

Tel.: +1 (908) 981-8745

Ashleigh.Koss@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

 

LOGO   

Press Release

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

Sanofi and Luminostics to join forces on developing breakthrough COVID-19 smartphone-based self-testing solution

 

   

Companies to negotiate a collaboration on the development of a breakthrough COVID-19 self-test solution based on Luminostics’ proprietary technology.

 

   

Sanofi to leverage its global distribution network to ensure global availability, subject to relevant regulatory approvals.

PARIS - April 16, 2020 - Sanofi and Luminostics have signed an agreement to evaluate a collaboration on a unique self-testing solution for COVID-19, using Luminostics’ innovative technology, and further adding to Sanofi’s ongoing efforts to fight the COVID-19 pandemic on multiple fronts.

Luminostics would contribute its proprietary technology for consumer-diagnostics for COVID-19 testing while Sanofi would bring its clinical research testing experience and capabilities. The goal is to provide a smartphone-based solution that eliminates the current need for healthcare professional administration or laboratory tests.

“This partnering project could lead to another important milestone in Sanofi’s fight against COVID-19. The development of a self-testing solution with Luminostics could help provide clarity to an individual – in minutes – on whether or not they are infected” says Alan Main, Executive Vice President, Head of Sanofi Consumer Healthcare. “Following this week’s announcement of an unprecedented partnership with GSK in the hunt for a vaccine, our company’s ambition is to continue to find other ways to help solve this pandemic situation.”

The goal of this collaboration is to provide a consumer-based test that can detect the COVID-19 virus with high sensitivity and specificity from respiratory samples. The total time from specimen collection to results is expected in the range of 30 minutes or less. It is based on Luminostics’ unique technology that utilizes a consumer smartphone’s optics, controlled by an iOS/Android app paired with an inexpensive adapter, in combination with “glow-in-the-dark” nanochemistry and signal processing artificial intelligence.

The diagnostic platform is composed of:

 

   

an iOS/Android app to instruct a user on how to run the test, capture and process data to display test results, and then to connect users with a telehealth service based on the results;

 

   

a reusable adapter compatible with most types of smartphones; and


   

consumables for specimen collection, preparation, and processing.

During the current COVID-19 crisis it became obvious that rapid, reliable mass testing is one of the key strategies for successful containment of a pandemic outbreak. While point-of-care tests were made available relatively quickly - although not in a sufficient quantity - no over-the-counter (OTC) self-testing solution is currently available. A rapid self-testing solution would come with multiple advantages, including:

 

   

easy access and availability to patients at thousands of points-of-sale including e-commerce;

 

   

no further interpersonal contact necessary to conduct the testing, thereby lowering the infection risk for patient, HCP, and laboratory staff; and

 

   

immediate availability of results allowing fast decision making, providing consumers both public health and out-of-pocket cost benefits.

As one of the leading companies in the fight against COVID-19, Sanofi is already engaged in multiple clinical trials evaluating current treatment options (Kevzara® and Plaquenil®) in patients suffering from COVID-19 as well as two vaccine programs.

Based on Luminostics’ existing technology and protypes, both companies envisage to start development activities in the coming weeks. In parallel, both parties expect to execute a final collaboration agreement including a plan for accelerated ramp up of necessary manufacturing capabilities. If development activities can be successfully conducted, the aim is to have an OTC self-testing solution ready before the end of 2020, subject to obtaining required regulatory clearances.

About Luminostics

Luminostics is a California-based startup with a mission to increase healthcare accessibility and efficiency by designing, developing, manufacturing, and delivering products that enable affordable, widespread access to actionable health testing with immediate follow-up. Luminostics is currently funded by top-tier venture capital firms in Silicon Valley and multiple scientifically peer-reviewed federal R&D grants or contracts. For further information please visit www.luminostics.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

Ashleigh Koss / Quentin Vivant

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 forwardlooking 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.