Press Releases

PARIS, April 27, 2018 /PRNewswire/ --  Sanofi (NYSE: SNY; EURONEXT: SAN)

Sanofi Chief Executive Officer, Olivier Brandicourt, commented:
"In the first quarter, the performance of our global operations, coupled with disciplined expense management, allowed us to manage the impact of the losses of exclusivity for Lantus^® and sevelamer in the U.S. Furthermore, with the consolidation of Bioverativ and the acquisition of Ablynx⁽⁹⁾, we have established the foundation for a global Rare Blood Disorder franchise which will further enhance our leadership in Specialty Care. Importantly, we continue to execute on our business priorities and position the Company for a new period of growth which is expected to begin in the second half of 2018."

Experience the interactive Multichannel News Release here: https://www.multivu.com/players/English/8315151-sanofi-earnings-results-q1-2018/

First-quarter 2018 reflected strong Specialty Care sales offset by U.S. Lantus^® and sevelamer exclusivity losses

• Net sales were €7,898 million, down 8.7% on a reported basis, down 0.4%⁽³⁾ at CER and down 1.1% at CS/CER⁽⁴⁾.
• Sanofi Genzyme sales grew strongly, up 16.2%⁽⁵⁾, driven by contribution from the new immunology franchise.
• Vaccines sales (-0.9%) reflected strong performance in EU, offset by expected Pentaxim^® supply constraint in China.
• CHC sales grew 2.0% supported by double-digit growth in Emerging Markets⁽⁶⁾.
• Diabetes and Cardiovascular GBU sales down 15.7%; global Diabetes franchise sales declined 10.0%.
• Emerging Markets sales⁽⁶⁾ increased 8.3%, driven by double-digit growth in China and Latin America.

2018 guidance confirmed

• First-quarter 2018 business EPS⁽¹⁾ increased 1.4% at CER to €1.28.
• First-quarter 2018 IFRS EPS was €0.81 (-82.0%) due to a gain on disposal of the Animal Health business in 2017.
• Sanofi continues to expect 2018 Business EPS to grow between 2% and 5% at CER⁽⁷⁾ barring unforeseen major adverse events. Applying the average April 2018 exchange rates, the currency impact on 2018 Business EPS is estimated to be around -7%.

Announcement of a €1.5bn share buyback program⁽⁸⁾ expected to be completed in mid-2019

Sanofi strengthens leadership in Specialty Care through the addition of a Rare Blood Disorder franchise

• Sanofi completed the acquisition of Bioverativ and consolidated its financial results from March 9.
• First patient dosed with fitusiran, a novel RNAi therapeutic for hemophilia, in phase 3 ATLAS program.
• Ablynx acquisition⁽⁹⁾ will add caplacizumab for aTTP⁽¹⁰⁾ (submitted in EU) and innovative Nanobody^® platform.

Sustaining innovation in R&D

• Praluent^® significantly reduced the risk of cardiovascular events in high risk patients in the ODYSSEY OUTCOMES study and was associated with a lower death rate.
• Dupixent^® supplemental BLA filed in the U.S., Japan and EU for moderate-to-severe asthma in adults and adolescents.
• Cemiplimab filed in EU for metastatic cutaneous squamous cell carcinoma.
• Sotagliflozin submitted in the U.S. and EU for type 1 diabetes.

(1) In order to facilitate an understanding of operational performance, Sanofi comments on the business net income statement. Business net income is a non-GAAP financial measure (see Appendix 8 for definitions). The consolidated income statement for Q1 2018 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) Excluding Animal Health gain on disposal, IFRS net income was down 19.9% and IFRS EPS was down 19.8%; (3) Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 8); (4) CS: Adjusted for Bioverativ acquisition; (5) Adjusted for Bioverativ acquisition: + 11.2% at CER/CS; (6) See definition page 7; (7) 2017 business EPS was €5.52; (8) Subject to the renewal of the authorization to repurchase Sanofi's own shares at the May 2, 2018 shareholders' meeting; (9) Subject to the completion of the acquisition; (10) Acquired thrombotic thrombocytopenic purpura

R&D update

Regulatory update

Regulatory updates since February 7, 2018 include the following:

• In March, the European Medicines Agency (EMA) accepted for review the Marketing Authorization Application for cemiplimab (collaboration with Regeneron) for the treatment of patients with metastatic cutaneous squamous cell carcinoma (CSCC) or patients with locally advanced CSCC who are not candidates for surgery.

• In March, the EMA accepted for review an application for Dupixent^® as an add-on maintenance treatment in certain adults and adolescents with inadequately controlled moderate-to-severe asthma. The U.S. Food and Drug Administration (FDA) also accepted for review the supplemental Biologics License Application of Dupixent^® as an add-on maintenance treatment in certain adults and adolescents with moderate-to-severe asthma. Per the Prescription Drug User Fee Act, the target action date is October 20, 2018.

• In March, the EMA accepted for review Sanofi's regulatory submission for sotagliflozin (developed in partnership with Lexicon) for adults with type 1 diabetes. Sotagliflozin was also submitted in the U.S. for type 1 diabetes.

At the end of April 2018, the R&D pipeline contained 74 projects including 37 new molecular entities in clinical development. 28 projects are in Phase 3 or have been submitted to the regulatory authorities for approval.

Portfolio update

Phase 3:

• The fitusiran phase 3 ATLAS program was reinitiated and the first patient was dosed in the ATLAS-INH study which will assess the benefit of fitusiran in adults and adolescents with hemophilia A or B with inhibitors.

• In March, ODYSSEY OUTCOMES results were presented during a late-breaker session at the American College of Cardiology. This trial met its primary endpoint, showing Praluent^® (alirocumab, collaboration with Regeneron) significantly reduced the risk of major adverse cardiovascular events (MACE) in patients who had suffered a recent acute coronary syndrome (ACS) event. Praluent^® was also associated with a lower risk of death overall, known as "all-cause mortality"⁽¹⁾, and there were also numerically fewer CHD deaths⁽²⁾. In a pre-specified analysis, the patients with baseline LDL-C levels at or above 100 mg/dL experienced a more pronounced effect from Praluent^®, reducing their risk of MACE by 24%⁽³⁾. In a post-hoc analysis of this group, Praluent^® was associated with a lower risk of death from any cause by 29%⁽⁴⁾.

• BIVV009 entered into Sanofi's portfolio through the acquisition of Bioverativ. BIVV009 is being evaluated in Cold Agglutinin Disease, a rare blood disorder and the first patient was dosed in phase 3.

Phase 2:

• The phase 2 proof of concept study evaluating the dual-agonist (SAR425899) in overweight and obese type 2 diabetic patients confirmed SAR425899 is a potent hypoglycemic agent and can induce significant weight loss. However, the gastrointestinal tolerability observed with the dose escalation regimen used in the study is not considered to be acceptable for clinical use. An additional study was initiated in the first quarter to explore alternative titration regimens to facilitate improved tolerability and adherence and is expected to read-out in 2018.

• SAR440340 (collaboration with Regeneron), a monoclonal antibody anti IL33, moved into phase 2 for the treatment of asthma.

Alliances/Collaboration

• In March, Evotec and Sanofi entered into exclusive negotiations for Evotec to accelerate infectious disease research and development through a new open innovation platform near Lyon in France.

(1)     HR=0.85; CI: 0.73-0.98, nominal p=0.026; (2) HR=0.92; CI: 0.76-1.11, p=0.38 ; (3) HR=0.76, CI: 0.65-0.87; (4) HR=0.71, CI: 0.56-0.90

To access the full press release of the 2018 Q1 results, please click here.

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, 2017. 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
+33 (0)1 53 77 45 45
Email: IR@sanofi.com

SOURCE Sanofi