2015/05 – deutsche bank hc conference
Post on 16-Jul-2015
182 Views
Preview:
TRANSCRIPT
Deutsche Bank Healthcare Conference Jérôme Contamine, Executive Vice President, Chief Financial Officer
Boston – May 6, 2015
2
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, 2014. Other than as required by applicable law, Sanofi does not undertake any
obligation to update or revise any forward-looking information or statements.
3
2
1
● Higher OpEx driven by new launches
● Business EPS up +2.6% at CER(2)
● Sales up +2.4% despite lower vaccines and U.S. Lantus®
sales(1)
● Solid performance of Genzyme and Merial
● Important milestones achieved for late stage R&D projects
● Multiple new product launches underway or imminent
Q1 2015 - A Good Start to the Year
3
Delivering top line growth
Posting strong financial
results
Bringing innovative medicines to market
(1) On a reported basis, Q1 2015 sales were up +12.3%
(2) On a reported basis, Business EPS was up +12.8%
Q1 2015 FX Impact
+€0.12
Incremental
EPS at CER
+€0.03
Q1 2014
Net Sales Business EPS
Solid Sales and Business EPS Delivered in Q1 2015
4
(1) On a reported basis, Q1 2015 sales were up +12.3% and Business EPS was up +12.8%
+2.6% at CER(1)
Q1 2015 FX Impact
+€782m
Incremental
Sales at CER
+€186m
Q1 2014
+2.4% at CER(1)
€7,842m
€8,810m
€1.17
€1.32
Net Sales(1) Business EPS
5
Strong FX Tailwind on Top and Bottom Line in Q1 2015
as the U.S. Dollar Strengthened
(1) Main currency impact on sales in Q1 2015: U.S. Dollar (+€551.3m); Chinese Yuan (+€77.5m);
Russian Ruble (-€64.0m);
Quarterly Currency Impact
-6.2%
-€497m -5.5%
-€443m
-1.0%
-€81m
+9.9%
+€782m
Q1 2015
Q1 2014 Q2 2014 Q3 2014
Q4 2014
+2.7%
+€229m
Q1 2015
Q1 2014 Q2 2014 Q3 2014
Q4 2014
-9.1%
-€0.11 -8.9%
-€0.10
-€0.03
-2.2%
+1.5%
+€0.02
+10.2%
+€0.12
(1) World excluding U.S., Canada, Western Europe (France, Germany, UK, Italy, Spain, Greece, Cyprus, Malta,
Belgium, Luxembourg, Portugal, the Netherlands, Austria, Switzerland, Sweden, Ireland, Finland, Norway,
Iceland, Denmark), Japan, South Korea, Australia, and New Zealand
(2) RoW: Japan, South Korea, Canada, Australia, and New Zealand
Balanced Geographical Sales Split in Q1 2015
with Solid Growth in Emerging Markets
32.5%
33.8%
23.1%
10.6%
6
(1)
€530m €586m
€846m €849m
Africa & MiddleEast
Eastern Europe,Russia & Turkey
Latin America Asia
+8.6% +7.1% +8.6% Growth at CER +2.7%
Emerging Markets Total Sales by Region
Emerging
Markets
€2,859m +7.3% at CER
U.S.
€2,976m +1.0% at CER
Western EU
€2,031m +0.6% at CER
RoW
€944m -3.5% at CER
(2)
Q1 2015 Sales by Geographies (in €m)
Q1 2015 Sales by Business Areas
(1) Q1 2015 sales were up +12.3% on a reported basis
Growth at CER
Consumer Healthcare
Generics
Genzyme
Diabetes
Oncology
€979m
€478m
€821m
€1,837m
€357m
+5.3%
+10.2%
+30.9%
-3.2%
-7.3%
Sales Growth Driven by Genzyme and Merial
in Q1 2015(1)
% of Sales
11.1%
9.3%
20.9%
5.4%
4.1%
Animal Health
Vaccines
€658m
€697m
+13.5%
-4.6%
7.9%
7.5%
Pharmaceuticals €7,455m
+2.2%
84.6%
7
Established Rx Brands €2,983m
-1.5%
33.8%
8
Genzyme Rare Disease Products Delivered Double-Digit
Growth in Q1 2015
● Rare Disease sales reached €613m in
Q1 2015, up 15.9%
● Sustained leadership positions(1)
in Gaucher, Fabry and Pompe diseases
● Gaucher disease products grew
10.1% to €199 million, including €10m
of Cerdelga® sales
● Over 60% of Cerdelga® patients are from
sources that do not cannibalize existing
Cerezyme sales
● Cerdelga® launched in its first EU market,
Germany, in April 2015
(1) Cerezyme® value share is 72% and Fabrazyme® value share is 62% based on Q1 2015 reported sales by Sanofi and Shire
&
Q1
2015
Q1
2014
Q1
2015
Q1
2014 Q1
2015
Q1
2014
€141m €156m
€199m
+27.6% at CER
+19.0% at CER
+10.1% at CER
Top 3 Rare Disease Sales (€m)
&
Q22013
Q32013
Q42013
Q12014
Q22014
Q32014
Q42014
Q12015
Genzyme’s Multiple Sclerosis Business Continued
to Accelerate in Q1 2015
Genzyme MS Franchise Sales (€m)
€208m ● MS sales up +118% at CER to €208m in
Q1 2015
● Aubagio® sales of €170m more than
doubled vs. €78m in Q1 last year
● Only oral treatment with sustained
accumulation of disability data in U.S. label
● Q1 2015 sales of Lemtrada® were €38m,
surpassing FY 2014 sales of €34m
9
€83m
Lemtrada® Aubagio®
Merial Started 2015 with Strong Growth Driven
by NexGard® Launch and Frontline® Stabilization
10
● Q1 2015 sales of €658m up +13.5%
● Companion animal sales up +13.1% to
€443m (67% of sales)
● Production animal sales up +14.5% to
€215m
● NexGard® sales more than doubled
in Q1 2015 compared to the same
period of 2014
● Frontline® family continued stable
performance with sales up +1.2% Q2
2013Q3
2013Q4
2013Q1
2014Q2
2014Q3
2014Q4
2014Q1
2015
-5.7% -6.3%
Merial Sales Growth at CER
-6.4%
-1.6%
+12.7%
+6.2%
+11.5%
+13.5%
11
Q1
2015
€697m
Q1
2014
€628m
Other
Adult Boosters
Travel/Endemic
Polio/Pertussis/Hib
Influenza Vaccines
Meningitis/Pneumo
Sanofi Pasteur Sales in Q1 2015 Reflect the Delay of the
Southern Hemisphere Influenza Campaign
● Q1 2015 Sanofi Pasteur sales were
€697m, down 4.6% at CER
● Excluding influenza vaccines, sales grew
17.2% in Q1
● Strong PPH sales of €282m, +15.6%
were driven by the continued recovery
of Pentacel® in the U.S.
● Sanofi Pasteur continues to address
remaining supply constraints in 2015
● Menactra® sales grew 50.0% to €87m
due to favorable CDC order phasing in
the U.S.
PPH: Polio, Pertussis, Hib vaccines
(1) Includes VaxServe, a U.S. healthcare supplier serving primary care physician offices, community
immunization providers, immunizing pharmacies, travel clinics and corporations
(1)
Vaccine Sales (€m)
-4.6% at CER
Q1 2014 Q2 2014 Q3 2014 Q4 2014 Q1 2015
Diabetes Sales Reflect Expected Change in U.S. Lantus®
Net Pricing
12
Diabetes Sales (€m)
€1,837m
● Global diabetes sales of €1,837m
down -3.2% at CER(1) in Q1 2015
● In Emerging Markets and Western EU,
diabetes sales were up +18.5% and
+4.7%, respectively
● U.S. Lantus® sales were down 13.1% due
to expected rebates required to maintain
favorable formulary positions
● Toujeo® sales were €7m reflecting
pre-launch wholesaler demand
● Afrezza® was launched in the U.S. in
Feb 2015
€1,662m
-3.2% at CER(1)
(1) On a reported basis, Q1 2015 diabetes sales were up +10.5% 12
Q1
2014
Q2
2014
Q3
2014
Q4
2014
Q1
2015
13
● Toujeo® was launched in the U.S. at the end of March
● Secured earlier and broader market access than expected
● Toujeo® COACH patient support program available at launch
● European Commission approved Toujeo® in April 2015
● Launch in Germany and UK expected in Q2 2015
● Launches in other countries expected in H2 2015 and early
2016
Global Launch of a New Once-Daily Long-Acting Basal
Insulin Underway
Sanofi Expects to Launch High Potential New Medicines
and Vaccines at an Accelerated Pace
14
Up to 18 Launches
2014 - 2020
sarilumab
(U.S.)
Dengue
Vaccine
patisiran Anti-CD38
mAb
PR5i
Vaccine
Vaccine
Shan5
(U.S.)
insulin
lispro
Rotavirus
Vaccine
Praluent™ is the intended trade name for alirocumab.
ILLUSTRATIVE
®
15
Praluent® (alirocumab) is developed in collaboration with Regeneron
(1) Rolling submission process initiated in some endemic countries in Asia and Latin America in 2015.
Regulatory Filings for Three Major New Medicines
or Vaccines Submitted over the Last Year
Key Regulatory Filings
U.S.
Pediatric hexavalent vaccine
PR5i 6-in-1
Endemic
markets(1)
Dengue
Dengue vaccine
U.S.
E.U.
Hypercholesterolemia
16
Praluent® Has the Potential to Transform Management
of Hypercholesterolemic Patients with High CV Risk
● Regulatory reviews underway in the U.S. and Europe
● FDA decision expected in July 2015(1)
● EU decision expected in Q1 2016
● 18-month results of ODYSSEY LONG TERM study were
published in NEJM(2)
● Fewer major CV events observed in post hoc analysis(3)
● ODYSSEY OUTCOMES trial ongoing(4)
● Assess potential to demonstrate CV benefit
(1) FDA PDUFA target action date of July 24, 2015
(2) Robinson JG, Farnier M, Krempf M, et al. Efficacy and safety of alirocumab in reducing lipids and cardiovascular
events. N Engl J Med 2015;372:1489-99. DOI: 10.1056/NEJMoa1501031
(3) Praluent group (27 of 1550 patients, 1.7%) compared with placebo group (26 of 788 patients, 3.3%; hazard ratio 0.52;
95 % CI, 0.31 to 0.90; nominal p < 0.01)
(4) ODYSSEY OUTCOMES (n=18,000): Rationale and design in Schwartz GG et al. Am Heart J 2014;0:1-8.e1.
On Track to Make Dengue
the Next Vaccine-Preventable Disease
● Rolling submission for Dengue vaccine initiated
in endemic countries in Asia and Latin America
● First completed submission expected in H1 2015
● First commercial batches produced and
inventory build-up underway
● Up to 80m lyophilized doses expected to be available
by end of 2015
● First license anticipated before year-end 2015
(1) WHO, 2012, Global Strategy for Dengue Prevention and Control
A Breakthrough Innovation to Help Reduce the Burden of Dengue(1)
17 17
(1) ELIXA evaluated cardiovascular outcomes in patients with Type 2 Diabetes after Acute Coronary Syndrome during
treatment with lixisenatide
(2) LixiLan is a once-daily fixed-ratio combination of insulin glargine and lixisenatide
(3) LixiLan-O evalutates the combination of insulin glargine and lixisenatide in patients insufficiently controlled on OADs
and LixiLan-L focuses on patients not at goal on basal insulin
Additional Clinical Milestones and Regulatory Filings
Expected in 2015
Key Milestones in 2015
18
Type 2 Diabetes
ELIXA study results
support U.S. regulatory
submission expected in
Q3 2015(1)
Type 2 Diabetes
Completion of two
Phase III trials
expected in Q3 2015(3)
U.S. regulatory
submission anticipated
in Q4 2015
(2)
Rheumatoid Arthritis
Further Phase III data
expected in 2015
Regulatory submission
expected in late 2015
in the U.S. and H2
2016 in EU
sarilumab
2015
Expected Regulatory Decisions Q1 Q2 Q3 Q4
● Toujeo® in Diabetes in U.S. & EU
● Praluent® (alirocumab) in Hypercholesterolemia (U.S.)
● PR5i 6-in-1 pediatric vaccine (U.S.)
● Dengue vaccine in Endemic Countries
Expected Regulatory Submissions Q1 Q2 Q3 Q4
● Lyxumia® in Diabetes (U.S.)
● LixiLan in Diabetes (U.S. & EU)
● Sarilumab in Rheumatoid Arthritis (U.S.)
Expected Headline Phase III Data Releases Q1 Q2 Q3 Q4
● Lyxumia® ELIXA CV outcome study in Diabetes
● LixiLan in Diabetes
● Sarilumab in Rheumatoid Arthritis
Expected Phase III Starts Q1 Q2 Q3 Q4
● Dupilumab in Asthma and Nasal Polyposis
Innovation Momentum Set to Continue in 2015
19
Net Debt (in €m)
Other Net Debt
Mar 31, 2015
-€773m
Acquisitions,
Licensing, Net
of Disposals
-€327m
Share Repurchase
-€794m
Proceeds from
Issuance of Shares
€247m
CapEx
-€355m
Net Cash from
Operating Activities
Net Debt
Mar 31, 2014
Net Debt Increased by 5.6% in Q1 2015 due to Translation
Impact of our Debt Held in U.S. Dollars
(1)
(2)
€7,171m €7,571m €1,602m
(3) (1)
FCF
€1,247m
FCF: Free Cash Flow
(1) Including derivatives related to the financial debt of +€302m at December 31st, 2014 and of +€360m at March 31st, 2015
(2) Excluding Restructuring costs
(3) Other including Restructuring costs of -€148m and FX impact of -€593m 20
Business EPS Growth
Approximately +12%(2)
Stable to slightly growing at CER(1)
21
(1) FY 2014 Business EPS of €5.20
(2) Difference between variation on a reported basis and variation at CER, when applying March 2015 average exchange rates
to the remaining three quarters of the year
Outlook for 2015 - Investing in Future Growth Drivers
FY 2015
FX impact on Business EPS
Our Focus Continues to Be on Excellence in Execution
of Sanofi’s Strategy
22
Adapt structure for future
challenges and opportunities 3
Bring innovative products
to market 2
Grow a global healthcare leader
with synergistic platforms 1
Seize value-enhancing
growth opportunities 4
2015 Focus
Maintain financial discipline
Focus company resources
on must-win priorities
Ensure successful launches
Strategy
Sustain leadership positions
top related