Sanofi Sa · EURONEXT:SAN
Sanofi Sa — Q1 2019 Earnings Presentation
38 slides from Sanofi Sa's earnings presentation, Apr 26, 2019
Slide 1: Q1 2019 Results
Q1 2019 Results April 26, 2019
Slide 2: Forward looking statements
Forward looking statements This presentation 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 under
Slide 3: Agenda
Agenda Key Highlights Olivier Brandicourt Chief Executive Officer Financial Results Jean-Baptiste de Chatillon Executive Vice President, Chief Financial Officer Olivier Charmeil Executive Vice President, China and Emerging Markets Karen Linehan Executive Vice President, Legal Affairs and General Cou
Slide 4: Key highlights
Key highlights Olivier Brandicourt Chief Executive Officer
Slide 5: Sanofi continued its return to growth in Q1 2019 with sales increase of 4.2%
Sanofi continued its return to growth in Q1 2019 with sales increase of 4.2% and EPS growth of 9.4% at CER Company sales Business EPS €8,391m €1.42 €7,898m €1.28 +4.2% +9.4% at CER(1) at CER Q1 2018 Q1 2019 Q1 2018 Q1 2019 CER: Constant Exchange Rates 5 (1) Q1 2019 sales increased +3.8% at CER/CS; C
Slide 6: Sales growth in Q1 2019 supported by launches and diminishing impact from LoEs in the U.S.
Sales growth in Q1 2019 supported by launches and diminishing impact from LoEs in the U.S. Q1 2019 company sales €8,233m +3.9% at CER +€190m €7,898m -€157m €7,741m +€480m -€178m Q1 2018 EU Generics Adjusted for U.S. Lantus®, Pharma, (1) Rare Blood Q1 2019 Disposal EU Gx Disposal U.S. sevelamer Vacci
Slide 7: Double-digit growth in GBUs partially offset by lower sales of Diabetes and Established Products
Double-digit growth in 3 GBUs partially offset by lower sales of Diabetes and Established Products in Primary Care Q1 2019 sales by Global Business Unit Growth at CER/CS(1) Company Sales €8,391m +3.8% (3) Sanofi Genzyme (Specialty Care) (2) €2,019m +16.0% Sanofi Pasteur (Vaccines) (5) €873m +20.1% P
Slide 8: Strong performance in Emerging Markets across franchises; Primary Care and CHC sales down in Mature Markets
Strong performance in Emerging Markets across franchises; Primary Care and CHC sales down in Mature Markets in Q1 Q1 2019 sales by geography Consumer Total sales Specialty Care Primary Care Vaccines Healthcare Growth at CER/CS €2,327m €3,935m €873m €1,256m €8,391m Global Sales +18.3% -4.7% +20.1% +0
Slide 9: Specialty Care delivered another record quarter in Q1 despite competitive dynamics in hemophilia
Specialty Care delivered another record quarter in Q1 despite competitive dynamics in hemophilia Specialty Care Sales evolution €2,327m +18.3% Rare Blood Disorder €274m Canada tender loss and U.S. competition affected growth in hemophilia +1.2% €1,710m €359m Immunology +186.3% Strong Dupixent® sales
Slide 10: Launch update on first-in-class therapies in Specialty Care
Launch update on first-in-class therapies in Specialty Care Rare Blood Disorder Oncology First therapeutic approved for aTTP First and only FDA approved in the EU and U.S. (2) therapy for CSCC aTTP mortality rate of up to 20% ~7,000 patients die annually in with current standard of care(1) the U.S.
Slide 11: Dupixent impressive launch continued in Q1 due to unmet need and best-in-class profile
Dupixent® impressive launch continued in Q1 due to unmet need and best-in-class profile in approved indications Pipeline in a product AD adults Asthma AD adolescents • Positive real world patient • ~75% of Dupixent® U.S. asthma • U.S. launch March 11th, 2019 experience drives uptake patients are naï
Slide 12: Robust Vaccines growth in Q1 driven largely by pediatric portfolio and Menactra in emerging markets
Robust Vaccines growth in Q1 driven largely by pediatric portfolio and Menactra® in emerging markets Q1 2019 Vaccines sales evolution • Vaccines sales of €873m, up 20.1% €33m €873m €23m • PPH vaccines sales grew 26% to €486m €106m • China sales: €75m, +208% due to recovery and growth of Pentaxim® 20
Slide 13: U.S. pricing dynamics continue to pressure performance of Primary Care core brands
U.S. pricing dynamics continue to pressure performance of Primary Care core brands Global Diabetes Sales (in € million) • Primary Care sales €3,935m, down 4.7% • Diabetes sales €1,294m down 6.9% €1,010m €943m • U.S. sales down -23% to €445m; U.S. Lantus® sales -37% • Non-U.S. sales +3.5%, driven by
Slide 14: CHC performance supported by growth across key categories in emerging markets in Q1
CHC performance supported by growth across key categories in emerging markets in Q1 Q1 2019 CHC sales by categories • CHC sales increased 0.6% to €1,256m €149m • Growth in Allergy, Cough & Cold, Pain, and Digestive -11.8% €362m • Strong sales in Emerging Markets (+8.1%) driven by Latin €152m +3.5% A
Slide 15: Double-digit growth in Emerging Markets driven primarily by high contribution from China in Q1 2019
Double-digit growth in Emerging Markets(1) driven primarily by high contribution from China in Q1 2019 Geographic breakdown of Q1 2019 sales €2,550m €2,187m U.S. EUROPE €312m €924m EURASIA(4) ROW(3) +7.1% -9.4% +22.1% +8.3% €556m of which €615m AME(5) €1,206m LATAM ASIA(2) €798m +12.0% CHINA +17.8%
Slide 16: Several potentially significant approvals for new drugs and additional indications over next 12 months
Several potentially significant approvals for new drugs and additional indications over next 12 months 2019 2020 Q2 Q3 Q4 Q1 Dupixent®(2) in Asthma in Adults and Adolescents (EU) ZynquistaTM(3) (sotagliflozin) in Type 1 Diabetes (EU) Cemiplimab(2,4) in Locally Advanced CSCC (EU) Potential Praluent®(
Slide 17: Financial results
Financial results Jean-Baptiste de Chatillon Executive Vice President, Chief Financial Officer
Slide 18: FX benefit on sales and EPS in Q1 mainly attributable to strengthening U.S. dollar
FX benefit on sales and EPS in Q1 mainly attributable to strengthening U.S. dollar Currency impact Company sales(1) Business EPS +€158m +€0.02 +1.5% +2.0% -€0.08 Q1 Q2 Q3 Q4 Q1 Q1 Q2 Q3 Q4 Q1 2018 2019 2018 2019 (1) Main currency impact on Company Sales in Q1 2019: US Dollar (+€202m), Brazilian Real
Slide 19: Double-digit BOI growth driven by increased sales, favorable mix and cost containment
Double-digit BOI growth driven by increased sales, favorable mix and cost containment €m Q1 2019 Q1 2018 % Change (CER) Net Sales 8,391 7,898 +4.2% Other revenues 322 228 +31.6% Gross Profit 6,097 5,611 +6.3% Gross margin % 72.7% 71.0% R&D (1,385) (1,280) +4.9% SG&A (2,380) (2,310) +0.6% Other curre
Slide 20: Strong business EPS growth in Q1 despite higher net financial expenses and broadly flat share count
Strong business EPS growth in Q1 despite higher net financial expenses and broadly flat share count €m Q1 2019 Q1 2018 % Change % Change (reported €) (CER) Net Sales 8,391 7,898 +6.2% +4.2% Gross Profit 6,097 5,611 +8.7% +6.3% Gross Profit margin % 72.7% 71.0% - - Business Operating Income 2,291 2,0
Slide 21: Q1 gross margin benefited from strong China growth and product mix; Opex in-line with expectations
Q1 gross margin benefited from strong China growth and product mix; Opex in-line with expectations Gross margin ratio(1) Operating expenses €3,765m 71.0% 72.7%(2) €3,590m +2.1% at CER(3) €1,280m €1,385m 71.7% +4.9% at CER R&D €2,310m €2,380m SG&A +0.6% at CER Q1 2018 Q1 2019 Q1 2018 Q1 2019 CER: Con
Slide 22: Reaffirming FY 2019 financial guidance
Reaffirming FY 2019 financial guidance FY 2019 Business EPS +3% to +5% at CER(1,2) Approximately +2%(3) FX impact on Business EPS based on April 2019 average exchange rates (1) Compared to FY2018 and barring major unforeseen adverse events (2) FY 2018 Business EPS was €5.47 22 (3) Difference between
Slide 23: Key highlights
Key highlights Olivier Brandicourt Chief Executive Officer
Slide 24: New growth phase continued in Q1 2019
New growth phase continued in Q1 2019 Net sales growth (at CER) • Improved growth profile extended into Q1 2019 6.3% • Impressive Dupixent® launch execution 3.9% 4.2% • U.S. pricing pressures impact Primary Care • Strong start with double-digit BOI growth 0.1% -0.4% • Reaffirming 2019 Full-Ye
Slide 25: Save the Date: Meet Sanofi Management
Save the Date: Meet Sanofi Management Wednesday, June 26, 2019 Series of in-depth Q&A discussions Management presentations Sanofi Headquarters - Paris 25
Slide 26: Finance appendices
SANOFI % Finance appendices Avy
Slide 27: Net debt evolution in Q1 2019
Net debt evolution in Q1 2019(1) €491m €1,234m €190m €44m €17,628m €116m €16,767m (2) Net Debt Free cash flow Acquisitions Restructuring Proceeds Share Capital Net Debt (3) December & Licences & Operational from disposal Increase March 31, 2019 (3) 31, 2018 Excellence of assets (1) Credit ratings re
Slide 28: 2019 currency sensitivity and Q1 2019 currency exposure
2019 currency sensitivity and Q1 2019 currency exposure 2019 Business EPS Currency Sensitivity Currency Variation Business EPS Sensitivity U.S. Dollar + 0.05 USD/EUR - EUR 0.10 Japanese Yen + 5 JPY/EUR - EUR 0.02 Chinese Yuan + 0.2 CNY/EUR - EUR 0.02 Brazilian Real + 0.4 BRL/EUR - EUR 0.01 Russian R
Slide 29: Business Net Income Statement – Q1 2019
Business Net Income Statement – Q1 2019 Merci beaucou Pharmaceuticals Consumer Healthcare Vaccines Others (1) Total Group € million Q1 2019 Q1 2018 Change Q1 2019 Q1 2018 Change Q1 2019 Q1 2018 Change Q1 2019 Q1 2018 Change Q1 2019 Q1 2018 Change Net sales 6,262 5,949 5.3% 1,256 1,238 1.5% 873 711 2
Slide 30: Consolidated Income Statements
Consolidated Income Statements € million Q1 2019 Q1 2018 Net sales 8,391 7,898 Other revenues 322 228 Cost of sales (2,618) (2,545) Gross profit 6,095 5,581 Research and development expenses (1,385) (1,280) Selling and general expenses (2,376) (2,312) Other operating income 64 25 Other operating exp
Slide 31: Reconciliation of Business Net Income to consolidated Net income attributable to equity holders of Sanofi – Q1 2019
Reconciliation of Business Net Income to consolidated Net income attributable to equity holders of Sanofi – Q1 2019 € million Q1 2019 Q1 2018 Change Net income attributable to equity holders of Sanofi 1,137 1,016 11.9% (1) Amortization of intangible assets 557 458 Impairment of intangible assets 5 3
Slide 32: Research & Development appendices
Research & Development appendices
Slide 33: R&D Pipeline – New Molecular Entities
R&D Pipeline – New Molecular Entities(*) Phase 1 Phase 2 Phase 3 Registration (Total : 17) (Total : 8) (Total : 7) (Total : 2) SAR441344(**)(1) BIVV001(**)(5) SAR440340(**)(12) SAR422459(**)(14) isatuximab cemiplimab(**)(12) Anti-CD40L mAb rFVIIIFc – vWF – XTEN(6) Anti-IL33 mAb ABCA4 gene therapy An
Slide 34: Additional Indications
Additional Indications(*) Phase 1 Phase 2 Phase 3 Registration (Total : 5) (Total : 19) (Total : 21) (Total : 5) SAR439459 + cemiplimab(**)(1) dupilumab(**)(1) isatuximab + cemiplimab(**)(1) dupilumab(**)(1) Isatuximab dupilumab(**)(1) Anti-TGFb mAb + PD-1 inh mAb Anti-IL4Rα mAb Anti-CD38 mAb + PD-1
Slide 35: Expected Submission Timeline
Expected Submission Timeline(1) isatuximab fitusiran avalglucosidase alfa venglustat SAR156597 SP0232 (**)(10) NMEs anti-CD38 mAb RNAi anti-thrombin Neo GAA Oral GCS inhibitor IL4/IL13 bi-specific mAb Respiratory syncytial virus mAbs 3L RRMM (ICARIA) Hemophilia A/B Pompe Disease ADPKD(8) Systemic Sc
Slide 36: Pipeline Movements Since Q4 2018
Pipeline Movements Since Q4 2018 Additions Removals (**)(1) dupilumab(**)(1) dupilumab Fluzone® QIV HD Registration Anti-IL4Rα mAb Anti-IL4Rα mAb Quadrivalent inactivated CRSwNP Nasal Polyposis) Influenza vaccine - High dose) Phase 3 isatuximab isatuximab dupilumab(**)(1) dupilumab(**)(1) Phase 2 An
Slide 37: R&D Pipeline Summary – Total Projects
R&D Pipeline Summary – Total Projects(1) Phase 1 Phase 2 Phase 3 Registration TOTAL Immuno-inflammation 1 9 6 3 19 Oncology 11 7 7 1 26 Rare Diseases 0 4 3 0 7 Rare Blood Disorders 4 0 2 0 6 Multiple Sclerosis and 3 3 2 0 8 Neurology Diabetes 0 0 4 1 5 Cardiovascular Disease 0 0 1 1 2 Vaccines 3 4 3
Slide 38: Expected R&D Milestones
Expected R&D Milestones Products Expected milestones Timing Dupixent® EU regulatory decision in Asthma in Adult and Adolescent patients Q2 2019 ZynquistaTM (sotagliflozin) EU.regulatory decision in Type 1 Diabetes Q2 2019 cemiplimab EU regulatory decision in Locally Advanced Cutaneous Squamous Cell