First-quarter sales(2) growth driven by Specialty Care, Vaccines and strong contribution from Emerging Markets
Net sales were €8,391 million, an increase of 6.2% on a reported basis, 4.2%(2) at CER and 3.8% at CER/CS(3).
Sanofi Genzyme GBU sales were up 30.8% (16.0% at CER/CS(3)), driven by Dupixent® and consolidation of Bioverativ.
Vaccines sales up 20.1%, reflecting the recovery and growth of Pentaxim® in China and Menactra® strength in Emerging Markets.
CHC sales up 0.6%, as Emerging Markets growth more than offset lower sales in mature markets and non-core divestments.
Primary care GBU sales were down 17.0% (-11.8% at CER/CS) impacted by lower diabetes sales and divestiture of EU generics.
Emerging Markets sales(4) grew strongly (up 13.6%) across all regions, primarily driven by China.
Q1 2019 business EPS(1) growth reflected sales performance, favorable product mix and cost discipline
Q1 2019 business net income increased 10.5% to €1,765 million and 9.0% at CER.
Business EPS(1) in the first quarter was up 9.4% at CER to €1.42.
IFRS EPS was €0.91 (up 12.3%).
Full-year 2019 business EPS(1) guidance confirmed
Sanofi continues to expect 2019 business EPS(1) to grow between 3% and 5% at CER(5) barring unforeseen major adverse events. Applying the average April 2019 exchange rates, the currency impact on 2019 business EPS is estimated to be around 2%.
Key regulatory milestones achieved in R&D
Dupixent® approved in the U.S. for atopic dermatitis in adolescent patients.
FDA granted Priority Review in the U.S. for Dupixent® in adults with chronic rhinosinusitis with nasal polyps.
CHMP recommended approval of Dupixent® in EU for severe asthma in adults and adolescents.
Praluent® label extension approved by EMA to include reduction of the risk of cardiovascular events in eligible patients.
Libtayo® approved in Canada for cutaneous squamous cell carcinoma.
CHMP recommended approval in EU and U.S. FDA issued a CRL(6).regarding ZynquistaTM for type 1 diabetic adult patients.
Sanofi Chief Executive Officer, Olivier Brandicourt, commented: "I am pleased with the strong start in 2019 as we sustained our new growth phase and delivered business EPS growth of 9.4%. We executed on key launches in Specialty Care led by the impressive uptake of Dupixent® in atopic dermatitis and asthma and also delivered strong growth in Vaccines. At the same time, our new GBU structure enabled us to optimize our growth opportunity in China & Emerging Markets and to adapt to the pressures in Primary Care. Based on our performance in the first quarter, we remain confident in the growth outlook for our business over the rest of the year despite challenging industry dynamics."
(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 2019 is provided in Appendix 3 and a reconciliation of reported IFRS net income to business net income is set forth in Appendix 4; (2) Changes in net sales are expressed at constant exchange rates (CER) unless otherwise indicated (see Appendix 8); (3) Constant Structure: Adjusted for Bioverativ acquisition and divestment of European Generics business; (4) See definition page 8; (5) 2018 business EPS was €5.47; (6) Complete Response Letter.
R&D update
Consult Appendix 6 for full overview of Sanofi's R&D pipeline
Regulatory update
Regulatory updates since February 7, 2019 include the following:
In March, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion for ZynquistaTM (sotagliflozin, developed by Sanofi and Lexicon), a dual SGLT1 and SGLT2 inhibitor, recommending its approval in the European Union for the treatment of adults with type 1 diabetes. In March, the U.S. Food and Drug Administration (FDA) issued a Complete Response Letter regarding the New Drug Application for Zynquista™ for the treatment of adults with type 1 diabetes in combination with insulin.
In March, Praluent® (collaboration with Regeneron) was approved in the European Union to reduce the risk of cardiovascular events in patients with established cardiovascular disease
In March, the U.S. FDA approved Dupixent® (collaboration with Regeneron) for adolescent patients 12 to 17 years of age with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies, or when those therapies are not advisable.
In March, the U.S. FDA accepted for Priority Review the supplemental Biologics License Application (sBLA) for Dupixent® as an add-on maintenance treatment for adults with inadequately-controlled severe chronic rhinosinusitis with nasal polyps (CRSwNP). The target action date for the FDA decision is June 26, 2019.
In March, the European Medicines Agency's CHMP adopted a positive opinion for Dupixent®, recommending its approval in the European Union for use in adults and adolescents (12 years and older) as add-on maintenance treatment for severe asthma with type 2 inflammation characterized by raised blood eosinophils and/or raised FeNO who are inadequately controlled with high dose inhaled corticosteroid plus another medicinal product for maintenance treatment.
In the first quarter, the U.S. FDA accepted for review a supplemental Biologic License Application (sBLA) for Fluzone® HD QIV.
At the end of April 2019, the R&D pipeline contained 84 projects including 32 new molecular entities in clinical development. 35 projects are in phase 3 or have been submitted to the regulatory authorities for approval.
Portfolio update
Phase 3:
In February, positive results from two phase 3 trials evaluating Dupixent® in patients with recurring severe CRSwNP were presented at the 2019 Annual Meeting of the American Academy of Allergy, Asthma & Immunology.
Phase 2:
A phase 2b/3 study evaluating Dupixent® in Chronic Obstructive Pulmonary Disease (COPD) is in the process of being initiated.
A phase 2b study evaluating SAR442168, a BTK inhibitor (collaboration with Principia), in multiple sclerosis was initiated.
A phase 2 study evaluating isatuximab in combination with chemotherapy in pediatric patients with relapsed refractory acute lymphoblastic leukemia or acute myeloid leukemia was initiated.
Phase 1:
SAR441169, a RORC (ROR gamma T) antagonist entered phase 1 for the treatment of psoriasis.
Collaboration
In April, Sanofi and Alnylam agreed to conclude the research and option phase of the companies' 2014 RNAi therapeutics alliance in rare genetic diseases. The material collaboration terms for patisiran, vutrisiran (ALN-TTRsc02) and fitusiran, as previously announced, will continue unchanged. As part of this agreement, Alnylam will advance an additional investigational asset in an undisclosed rare genetic disease through the end of IND-enabling studies. Sanofi will be responsible for any potential further development or commercialization of such asset. In addition, Alnylam and Sanofi have agreed to amend certain terms of the companies' equity agreement, with Sanofi obtaining a release of its lock-up of Alnylam stock holdings, subject to certain trading restrictions, among other provisions.
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.
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