2014/09 - bank of america merrill lynch hc
DESCRIPTION
September 18, 2014 - Bank of America Merrill Lynch Healthcare ConferenceTRANSCRIPT
BofA-ML Global Healthcare Conference
London, September 18th, 2014 Jérôme Contamine, Executive Vice-President, Chief Financial Officer
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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 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 labeling 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, the Group's ability to benefit from external growth opportunities, trends in exchange rates and prevailing interest rates, the impact of cost containment policies 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, 2013. 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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Agenda
● Q2 2014 Key Highlights
● Q2 2014 Financial Performance
● Conclusion
● Net sales up +6.4% at CER and Business EPS up +13.4% at CER ● Free Cash Flow up +33% in H1 2014 ● €3.7bn dividend payment and €1.1bn share buyback
● 76.3% of Group sales ● Solid execution in Emerging Markets ● Merial back to growth
● 3 significant regulatory reviews ongoing ● 4 major projects with Phase IIb/III readouts ● 2 new important collaborations
Sanofi Delivered Solid Results in Q2 2014
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3
2
1 Solid financial performance
Strong performance
of Growth Platforms
Significant progress
in late stage pipeline
FCF: Free Cash Flow (1) Excluding Generics in Brazil, Q2 2014 sales were up +3.9% at CER (2) Dividend payment of €3,676m on full-year 2013 results made in Q2 2014 (3) As of July 15th 2014, Sanofi bought back shares for €1,100m in YTD 2014 (4) World excluding U.S., Canada, Western Europe (France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg,
Portugal, Holland, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark), Japan, Australia, and New Zealand
(1)
(3) (2)
(4)
Q2 2014
-€0.10
FX Impact Incremental EPS at CER
Q2 2013
+€0.15
Net Sales(1) Business EPS(1)
Solid Q2 2014 Financial Performance Reflects Consistent Execution of our Growth Strategy
5 (1) On a reported basis, Q2 2014 sales were up +0.9% and Business EPS was up +4.5% (2) With retroactive application of IFRIC21
+13.4% at CER(1)
Incremental Sales at CER
Q2 2014 Q2 2013 FX Impact
+€515m -€443m
+6.4% at CER(1)
€8,003m €8,075m €1.12
€1.17 (2)
1
(2)
2014 Business EPS Guidance Adjusted Slightly Upwards
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(1) As presented on July 31, 2014 at the time of Sanofi’s Q2 2014 results announcement (2) FY 2013 Business EPS of €5.05 with retroactive application of IFRIC21
6
Given our financial performance in H1 2014 and despite increasing U.S. competitive pressure at the payor level,
2014 business EPS is expected to be between 6% to 8% higher than 2013 at CER(2),
barring major unforeseen adverse events
1
FY 2014 Guidance
(1)
Evolution of Share Buyback(1,2)
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SBB: Share Buyback (1) As of July 15th 2014, YTD 2014 share buyback of €1,100m and YTD 2014 proceeds from share issuance of €252m (2) Number of shares outstanding in million on Dec 31st 2012, Dec 31st 2013 and June 30th 2014
€646m
€1,100m
€252m
€823m
€1,641m
€1,004m
2012
Sanofi Increased Buyback Activity in H1 2014
2013 YTD 2014
€177m Net SBB
€637m Net SBB
€848m Net SBB
Share count (m) 1,323.2 1,320.7 1,312.1
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Issuance Issuance Issuance Buyback Buyback Buyback
Quarterly Sales Growth from Growth Platforms(1)
+6.2%
Q1 2013
+8.6%
Q4 2012
+11.5%
Q3 2012
+6.4%
Q2 2012
+7.6%
Q1 2012
+5.7%
Q4 2013
+10.0%
Q3 2013 Q2 2013
+5.5%
+7.9%
Q1 2014 Q2 2014
+10.7%
(1) Growth at CER. Q1 2012 growth restated for Genzyme Q1 2011 (€396m) (2) Growth at CER including Generics in Brazil was +2.5% in Q2 2013 and +14.5% in Q2 2014 8
Growth Platforms Show Consistent Strong Performance Demonstrating the Value of our Business Model
(2)
(2)
+5% at CER
+10% at CER
2
% of Group sales 63.2% 76.3%
+9.2% Consumer Healthcare(3)
€816m
Vaccines -4.2% €718m
Genzyme(4)
Growth Platforms Grew +14.5%(1) in Q2 2014 Reaching 76.3% of Sales
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(1) Excluding Generics in Brazil, Growth Platforms grew +10.7% in Q2 2014 and +9.0% in H1 2014 at CER (2) Excluding Generics in Brazil, Emerging Markets grew +8.6% in Q2 2014 and +6.5% in H1 2014 at CER (3) Some products recorded in prescription pharmaceuticals in 2013 were transferred as Consumer Healthcare products and totaled €73m in Q2 2013
Including this category change, sales of Consumer Healthcare grew +20.2% in Q2 2014 and +19.4% in H1 2014 at CER (4) Genzyme perimeter includes Rare Diseases and Multiple Sclerosis franchises (5) Includes products launched since 2009 which do not belong to the Growth Platforms listed above: Multaq®, Jevtana®, Auvi-Q™, Mozobil® and Zaltrap®
+16.2%
-0.4%
+29.1%
+6.2%
Other Innovative Products(5) €189m +13.3%
+16.5%
Diabetes Solutions €1,788m
Animal Health
€643m
Emerging Markets(2) €2,855m
€537m
Q2 2014 Growth at CER
2
-4.2%
H1 2014 Growth at CER
+9.3%
+14.7%
-2.2%
+25.4%
+2.2%
+17.8%
+11.0%
H1 2014 Geographic Sales Mix
(1) World excluding U.S., Canada, Western Europe (France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta, Belgium, Luxembourg, Portugal, Holland, Austria, Switzerland, Sweden, Ireland, Finland, Norway, Iceland, Denmark), Japan, Australia, and New Zealand
(2) Pharmaceuticals sales growth at CER was +2.2% in Africa & Middle East, +4.3% in Eastern Europe, Russia & Turkey, +10.6% in Asia and +18.2% in Latin America excluding Generics in Brazil in H1 2014
Solid Sales Performance in Emerging Markets in H1 2014 as Operational Issues from 2013 Have Been Addressed
Emerging Markets €5,445m
U.S. €4,984m
Western EU €3,906m
RoW €1,582m
34.2%
31.3%
24.5% 10.0%
10
(1) €1,006m
€1,239m
€1,519m €1,618m
Africa & MiddleEast
Eastern Europe,Russia & Turkey
Asia Latin America+8.5%
+4.7% +5.4% +14.6% Growth at CER
-1.5%
-7.4%
-0.7%
+11.0%
2
Emerging Markets Total Sales by Region
excluding Brazil Generics
(2)
Merial Returned to Growth in Q2 2014
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● Successful launch of NexGard®
● First soft, beef-flavored chew treating fleas and ticks for dogs in the U.S.
● €58m sales in H1 2014
● Frontline® family sales stabilized in Q2 2014 ● Start of flea and tick season not
disrupted by weather conditions except in Northern U.S.
● Effective investment in ad campaign reinforcing strong Frontline® brand
2
Q2 Q1 Q4 Q3
-3.1%
-5.7% -6.3%
2013
Merial Sales Growth at CER
-6.4%
-1.6%
+6.2%
Q2 Q1
2014
● Filed in the U.S. and EU in Q2 2014 and recently in Japan
● Regulatory decisions for marketing authorization in the U.S. and EU anticipated in H1 2015
Three New Medicines Under Regulatory Review with the Potential to Meaningfully Improve Patient Lives
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● FDA approval granted in August 2014
● EU regulatory decision expected in Q4 2014
● NDA submitted in Japan in June, 2014
● sBLA resubmission accepted for review by FDA in May 2014
● FDA action expected in Q4 2014
● New dedicated salesforce being recruited
3
Three major new drug approvals expected over the next 12 months
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● Primary efficacy endpoint met in all 9 trials(1)
● LDL reduction consistent with previous trials
● Generally well tolerated in the 9 ODYSSEY trials(2)
● Lower rate of adjudicated major CV events(3, 4)
observed in a post-hoc analysis of ODYSSEY LONG TERM (p-value <0.05)
● Potential to demonstrate CV benefit being prospectively assessed in an 18,000-patient ODYSSEY OUTCOMES trial
● U.S. and EU regulatory submissions expected by end of 2014
Alirocumab is developed in collaboration with Regeneron (1) The nine trials included ODYSSEY LONG TERM, FH I, FH II, HIGH FH, COMBO I, COMBO II, OPTIONS I, OPTIONS II and ALTERNATIVE (2) The most common adverse events were nasopharyngitis and upper respiratory tract infections, which were generally balanced between treatment
groups. Injection site reactions occurred more often in the alirocumab group compared to placebo. Serious adverse events and deaths were generally balanced between treatment groups as were other key adverse events including musculoskeletal, neurocognitive and liver-related events.
(3) Major CV events included cardiac death, myocardial infarction, stroke, and unstable angina requiring hospitalization (4) Based on a pre-specified interim safety analysis performed when all patients reached one year and approximately 25% of patients reached 18 months
of treatment in the ongoing ODYSSEY LONG TERM trial with 2,341 patients at high or very high cardiovascular (CV) risk
Positive Top-Line Results across 9 Phase III Trials of Alirocumab in People with Hypercholesterolemia
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Sarilumab and dupilumab are developed in collaboration with Regeneron NEJM: New England Journal of Medicine (1) Efficacy per serotype (ST1 50.3%, ST2 42.3%, ST3 74.0%, ST4 77.7%) (2) Mean % change in EASI score from baseline to Week 16 / Clearing or near-clearing of skin lesions, measured by an investigator's global assessment
(IGA) score of 0 or 1 / Mean reduction in itching measured by the pruritus numerical-rating scale (NRS) score (3) Improvement in signs and symptoms of RA / Improvement in physical function / Inhibition of progression of structural damage
Strong Late Stage Pipeline of Biologics Demonstrates the Shift of our Portfolio towards Innovative Products
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● Positive 2nd Phase III data released in September 2014 ● 60.8% reduction in
symptomatic dengue
● Efficacy against each of the four dengue serotypes(1)
● 80.3% reduction of the risk of hospitalization
Dengue Vaccine
● Detailed data from positive Phase III MOBILITY trial presented at EULAR ● Statistically significant
improvements in all three co-primary endpoints(3)
Sarilumab Rheumatoid Arthritis
● Strong Phase IIa data published in the NEJM
● Positive Phase IIb top-line results ● Statistically significant and
dose-dependent improvements in all key efficacy measures(2)
Atopic Dermatitis
Two New Collaborations Signed in Q2 2014 Strengthening our CHC and Diabetes Growth Platforms
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● Licensing agreement with Lilly
● Opportunity to switch Cialis® from Rx to OTC in the U.S., Europe, Canada and Australia(1)
● Ambition to transform how this important medicine for erectile dysfunction (ED) is offered to millions of men in the world
● Global strategic alliance(2) in diabetes structured as open-innovation model
● Initial focus on novel drug-device combinations and care management
● Objective to improve adherence, simplify insulin treatment and help patients better manage their condition
3
(1) Subject to Sanofi's receipt of all necessary regulatory approvals (2) Implementation of the alliance is subject to the negotiation and execution of a definitive agreement between the companies
Strong Innovation Momentum Expected to Be Maintained in H2 2014
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2014 Expected Regulatory Decisions Q3 Q4 ● Cerdelga™ (eliglustat) in Gaucher disease (U.S.)
● Lemtrada™ (alemtuzumab) in Multiple Sclerosis (U.S.) ● Cerdelga™ (eliglustat) in Gaucher disease (EU) ● Fluzone® QIV Intradermal (U.S.) Expected Regulatory Submissions Q3 Q4 ● PR5i 6-in-1 pediatric vaccine (U.S.)
● Alirocumab in Hypercholesterolemia (U.S. & EU) Expected Headline Phase III Data Releases Q3 Q4 ● Alirocumab in Hypercholesterolemia (9 ODYSSEY trials)
● Dengue vaccine 2nd Phase III trial in Latin America
Expected Phase III Starts Q3 Q4 ● Dupilumab in Atopic Dermatitis
● Rotavirus vaccine ● Insulin lispro in Diabetes
3
Sanofi to Organize an IR Thematic Seminar on New Medicines and Vaccines
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● Discussing the market opportunity for key pipeline projects
● Emphasizing the shift of our portfolio to biologics
● Presenting further progress of our innovative R&D assets
IR Thematic Seminar on New
Medicines
Thursday November 20th, 2014 in Genzyme HQ - Cambridge, MA
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Agenda
● Q2 2014 Key Highlights
● Q2 2014 Financial Performance
● Conclusion
Net Sales(1) Business EPS
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FX Impact in Q2 2014 Was Comparable to Q1 2014 and In Line with our Expectations
(1) Main currency impact on sales in Q2 2014: U.S. Dollar (-€129m); Brazilian Real (-€48m); Japanese Yen (-€39m); Russian Ruble (-€33m); Argentine Peso (-€32m); Turkish Lira (-€23m), Canadian Dollar (-€15m) and Australian Dollar (-€14m)
(2) Difference between variation on reported basis and variation at constant exchange rates
Quarterly Currency Impact
-2.5%
-€212m
-4.4%
-€0.08
-3.5%
-€305m
2013
-€0.08
-5.5%
-7.3%
-€662m -€0.17
-10.2%
Q4 Q3 Q2 Q1
-7.3%
-€627m
2014 Q1
-€0.16
-13.7%
-6.2%
-€497m -9.1%
-€0.11
Assuming June exchange rates remain stable in H2 2014, negative FX impact on full-year Business EPS would be ~5%(2)
Q2
-5.5% -€443m
2013 Q4 Q3 Q2 Q1
2014 Q1 Q2
-8.9%
-€0.10
(1) With the retroactive application of IAS19R (2) Includes a payment of €62m before tax resulting from the return of U.S. rights for Eligard® to TOLMAR Pharmaceuticals (3) Includes a payment of €165m before tax associated to the sale of U.S. tail products to Covis Pharmaceuticals 20
BOI Increased Faster than Sales in Q2 2014
€m Q2 2014 Q2 2013 % Change (reported €)
% Change (CER)
Net sales 8,075 8,003 +0.9% +6.4%
Other revenues 71 83 -14.5% -12.0%
Cost of sales (2,608) (2,670) -2.3% +2.2%
Gross profit 5,538 5,416 +2.3% +8.2%
R&D (1,188) (1,185) +0.3% +3.2%
SG&A (2,255) (2,306) -2.2% +2.6%
Other current operating income & expenses 54 141 - -
Share of Profit/Loss of associates 26 3 - -
Minority interests (30) (45) - -
Business operating income 2,145 2,024 +6.0% +15.0%
Business operating margin 26.6% 25.3% - -
CER: Constant Exchange Rates
(1)
(2) (3)
Improvement in Gross Margin in Q2 2014 vs. Q2 2013
● Cost of Sales (CoS) in Q2 2014: €2,608m, up +2.2% at CER
● CoS ratio down 1 percentage point in Q2 2014 vs. Q2 2013 ● Reflecting recovery of Generics
in Brazil and higher margin from Genzyme
● Slight negative mix impact from Vaccines and Animal Health
● Unfavorable currency variations
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Gross Margin (%)
Q1 Q2 Q3 Q4 Q1 Q2
2013 2014
69.0% 69.6% 67.7% 67.0% 66.8% 68.6%
Q1 Q2 Q3 Q4 Q1 Q2
R&D Expenses Slightly Increased in Q2 2014 Despite Significant Investment in Phase III Trials
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● Q2 2014 R&D expenses of €1,188m, up +3.2% at CER
● Slight increase in R&D spend in line with guidance ● Higher spend in three large
development programs for mAbs (alirocumab, sarilumab, dupilumab)
● More than offsetting internal costs savings
22
R&D Expenses (€m)
€1,188m €1,185m
(1) With retroactive application of IFRIC21
(1)
2013 2014
Lower SG&A to Sales Ratio in Q2 2014 vs. Q2 2013
23
● Q2 2014 SG&A expenses of €2,255m, up +2.6% at CER ● Lower increase in SG&A than Sales
● Modest SG&A increase driven by investment in product launches ● NexGard™, Nasacort® OTC and
Genzyme MS franchise
23
SG&A Expenses (€m)
Q1 Q2 Q3 Q4 Q1 Q2
€2,255m €2,306m (1)
(1) With retroactive application of IFRIC21
2013 2014
CER: Constant Exchange Rates
24
€m Q2 2014 Q2 2013 % Change (reported €)
% Change (CER)
Business operating income 2,145 2,024 +6.0% +15.0%
Net financial expenses (94) (137) - -
Income tax expense (514) (408) - -
Effective tax rate -25.0% -21.2% - -
Business net income 1,537 1,479 +3.9% +13.0%
Net margin 19.0% 18.5% - -
Business EPS €1.17 €1.12 +4.5% +13.4%
Average number of shares outstanding (m) 1,314.5 1,325.7 - -
Strong Business EPS Growth of +10% in H1 2014
24 (1) With the retroactive application of IFRIC21 (2) Included a capital gain of €31m before tax resulting from the sale of several financial investments
(1)
(2)
-€0.06 -5.4%
Disposals & Capital Gains
-€0.05 -4.5%
Brazil Generics
€0.16 +14.3%
Business EPS Q2 2013
Reported
€1.12
€1.27
Business EPS Q2 2014
Reported
Fx
€1.17
Organic Growth
-€0.10 -8.9%
€0.10 +8.9%
Tax Rate Business EPS Q2 2014
@ CER
25
Business EPS (in €)
Business EPS Organic Growth Larger than Sales Growth in Q2 2014
Net Debt (in €m)
Dividend
€487m
Other Net Debt Jun 30, 2014
€3,676m
Acquisitions, Licensing, Net of Disposals
€1,608m
Share Repurchase
€1,010m
Proceeds from Issuance
of Shares
€240m
CapEx
€529m
Net Cash from Operating Activities
Net Debt Dec 31, 2013
Free Cash Flow (FCF) Increased by 33% in H1 2014
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(1)
(2)
€6,043m
€10,194m
€2,919m
(4) (1)
FCF €2,390m
FCF: Free Cash Flow (1) Including derivatives related to the financial debt +€290m at December 31st 2013 and +€296m at June 30th 2014 (2) Excluding Restructuring costs (3) Including €1,050m in Regeneron and €530m in Alnylam (4) Other including Restructuring costs
(3)
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Agenda
● Q2 2014 Key Highlights
● Q2 2014 Financial Performance
● Conclusion
Solid H1 Performance Reflects Consistent Execution of our Growth Strategy
Over 75% of sales now being generated by Growth Platforms
Business EPS guidance for 2014 adjusted slightly upwards
Late stage pipeline moving to launch execution
Expected new medicine launches to further redefine Sanofi
as a biopharmaceutical leader
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