Press Releases

PARIS, Oct. 28, 2016 /PRNewswire/ -- Sanofi (NYSE: SNY; EURONEXT: SAN)

Experience the interactive Multimedia News Release here: https://www.multivu.com/players/English/7788753-sanofi-earnings-results-q3-2016

Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
"We have generated solid sales momentum in the third quarter and seen a strong contribution to our financial performance from savings and efficiencies arising from our more focused organization. As a result, we are able to increase our FY 2016 Business EPS guidance. In addition, we have continued to work diligently to progress our major launches and the pipeline. With the filing of Dupixent^®, we now have another important product under FDA review which we believe will enhance Sanofi's growth profile in the coming years."

2016 guidance raised on strong third-quarter financial results

• Aggregate Company sales increased 3.0% (up 2.1% at 2016 exchange rates) to €9,652 million.
• Business EPS was up 12.4% at CER to €1.79 and up 11.2% on a reported basis.
• Given the performance in the first nine months, Sanofi now expects 2016 Business EPS to grow between 3% and 5% at CER, barring unforeseen major adverse events.

Continuing to execute the simplification of the portfolio consistent with our 2020 Roadmap

• Decision to initiate a carve-out process in order to divest the EU Generics business within 12-24 months.
• CHC asset swap with Boehringer Ingelheim on track to close around year-end.
• Cost savings now expected to be at least €1.5 billion by 2018.

Initiating a €3.5 billion share repurchase program to be completed by the end of 2017

Solid sales performance despite continuing headwinds in diabetes and the Plavix (clopidogrel bisulfate) LOE in Japan

• Sanofi Genzyme (Specialty Care) GBU continues to deliver double-digit growth (+16.9%).
• Sanofi Pasteur grew 14.4% supported by early flu vaccines shipment in the U.S.
• Diabetes and Cardiovascular GBU sales decreased 2.5%. Global diabetes franchise sales declined 1.5%.
• Aggregate sales in Emerging Markets grew 5.6% driven by Diabetes and Rare Disease portfolios.

Major launches and regulatory updates

• Toujeo^® (insulin glargine injection) generated worldwide sales of €167 million. LixiLan PDUFA date extended to November 2016.
• Praluent^® (alirocumab) now approved in 41 countries.
• Dengvaxia^® (dengue vaccine) generated sales of €30 million and is now approved in 13 countries.
• Sarilumab: CGMP observations during an FDA inspection of a Sanofi "fill-finish" facility could impact approval timing.
• Dupixent^® (dupilumab) BLA accepted for priority review by U.S. FDA with March 29, 2017 PDUFA date.

R&D update

Regulatory update

Regulatory updates since the publication of the second quarter results on July 29, 2016 include the following:

• In September, the U.S. Food and Drug Administration (FDA) accepted for priority review the Biologics License Application (BLA) for Dupixent for the treatment of adult patients with inadequately controlled moderate-to-severe atopic dermatitis. The application has been given a Prescription Drug User Fee Act (PDUFA) target action date of March 29, 2017. Furthermore, in October the FDA granted breakthrough designation status for Dupilumab in atopic dermatitis ages 12-18 moderate to severe patients and ages 6-11 for severe patients.
• In September, the Marketing Authorization Application of SAR342434 (insulin lispro) was accepted for review in the European Union for the treatment of diabetes.
• In August, Sanofi submitted updated information on the pen delivery device as part of the New Drug Application (NDA) for iGlarLixi (also known as LixiLan, the investigational once-daily fixed-ratio combination of basal insulin glargine and GLP-1 receptor agonist lixisenatide) for the treatment of adults with type 2 diabetes. The additional information, submitted at FDA's request, constitutes a Major Amendment to the NDA, resulting in an extension of the Prescription Drug User Fee Act goal date by three months, to late November 2016.
• In July, the sarilumab Marketing Authorization Application was accepted for review by the European Medicines Agency.
• Manufacturing deficiencies have been raised by the FDA during a routine Current Good Manufacturing Practice (CGMP) inspection of a Sanofi manufacturing facility, which conducts "fill and finish" activities. Sanofi has provided comprehensive responses to the FDA for the cited deficiencies. Given that the CGMP status of this facility is still under review by the FDA, it is unclear whether this situation will impact the approval for sarilumab on its PDUFA date of October 30, 2016.

At the end of October 2016, the R&D pipeline contained 43 pharmaceutical new molecular entities (excluding Life Cycle Management) and vaccine candidates in clinical development of which 12 are in Phase III or have been submitted to the regulatory authorities for approval.

Portfolio update

Phase III:

• In October, detailed results from LIBERTY AD SOLO 1 and SOLO 2, two placebo-controlled Phase 3 studies evaluating Dupixent in adult patients with inadequately controlled moderate-to-severe atopic dermatitis were presented at the Annual European Academy of Dermatology and Venereology (EADV) Congress and published in The New England Journal of Medicine (NEJM).
• Positive new six-year investigational data from the extension study of Lemtrada^® (alemtuzumab) in patients with relapsing remitting multiple sclerosis (RRMS) were presented in September at the Congress of the European Committee for Treatment and Research in Multiple Sclerosis (ECTRIMS).
• A new post-hoc analysis of data from the LixiLan-L pivotal Phase III clinical trial was presented at the European Association for the Study of Diabetes (EASD) and found that more patients who received iGlarLixi (the fixed-ratio combination of insulin glargine and GLP-1 receptor agonist lixisenatide) reached their daily post-prandial glucose target than those who received only insulin glargine. IGlarLixi is currently under review in the United States and Europe.
• Detailed positive results from ODYSSEY ESCAPE, a Phase III trial which evaluated Praluent injection in patients with an inherited form of high cholesterol known as heterozygous familial hypercholesterolemia (HeFH) who require regular apheresis treatment were presented at the ESC Congress.
• In October, Alnylam announced the development discontinuation of revusiran, an investigational RNA interference therapeutic that was being developed for the treatment of hereditary ATTR amyloidosis with cardiomyopathy.

Phase II:

• GZ389988, a TRKA antagonist, entered Phase IIa in osteoarthritis.

Phase I:

• SAR440340, a monoclonal antibody (alliance with Regeneron), entered Phase I in immuno-inflammation therapeutic area.
• SAR247799, a S1P1 agonist entered Phase I in the cardiovascular portfolio.
• It has been decided not to pursue the development of SAR366234, an EP2 receptor agonist.

Collaboration

• In September, Sanofi and Verily Life Sciences LLC, (formerly Google Life Sciences), an Alphabet company, announced the launch of Onduo, a joint venture created through Sanofi and Verily's diabetes-focused collaboration. Onduo's mission is to help people with diabetes live full, healthy lives by developing comprehensive solutions that combine devices, software, medicine, and professional care to enable simple and intelligent disease management.

To access the full press release of the 2016 Q3 results, please click here.

2016 guidance

Given the performance in the first nine months, Sanofi now expects 2016 Business EPS to grow between 3% and 5% at CER, barring unforeseen major adverse events. In addition, the currency impact on 2016 full-year business EPS is estimated to be around -4%, applying September 2016 average rates to the fourth quarter of 2016.

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 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, 2015. Other than as required by applicable law, Sanofi does not undertake any obligation to update or revise any forward-looking information or statements.

Media Relations:
Ashleigh Koss
908-981-8745
Email: Ashleigh.koss@sanofi.com

Investor Relations:
George Grofik
908-981-5560
Email: IR@sanofi.com

SOURCE Sanofi