IPSEN pour nom de la société - 07/04/2011 / page 1
Barclays - May 2016
Ipsen
2016 Healthcare Conference
2 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 2 2
Disclaimer This presentation includes only summary information and does not purport to be comprehensive. Forward-looking statements, targets and
estimates contained herein are for illustrative purposes only and are based on management’s current views and assumptions. Such statements
involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated
in the summary information. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties,
notably given that a new product can appear to be promising at a preparatory stage of development or after clinical trials but never be launched on
the market or be launched on the market but fail to sell notably for regulatory or competitive reasons. The Group must deal with or may have to deal
with competition from generic that may result in market share losses, which could affect its current level of growth in sales or profitability. The
Company expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in
this presentation to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based unless so
required by applicable law.
All product names listed in this document are either licensed to the Ipsen Group or are registered trademarks of the Ipsen Group or its partners.
The implementation of the strategy has to be submitted to the relevant staff representation authorities in each country concerned, in compliance
with the specific procedures, terms and conditions set forth by each national legislation.
Safe Harbor The Group operates in certain geographical regions whose governmental finances, local currencies or inflation rates could be affected by the
current crisis, which could in turn erode the local competitiveness of the Group’s products relative to competitors operating in local currency,
and/or could be detrimental to the Group’s margins in those regions where the Group’s drugs are billed in local currencies.
In a number of countries, the Group markets its drugs via distributors or agents: some of these partners’ financial strength could be impacted by
the crisis, potentially subjecting the Group to difficulties in recovering its receivables. Furthermore, in certain countries whose financial equilibrium
is threatened by the crisis and where the Group sells its drugs directly to hospitals, the Group could be forced to lengthen its payment terms or
could experience difficulties in recovering its receivables in full.
Finally, in those countries in which public or private health cover is provided, the impact of the financial crisis could cause medical insurance
agencies to place added pressure on drug prices, increase financial contributions by patients or adopt a more selective approach to reimbursement
criteria.
All of the above risks could affect the Group’s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic
conditions based on the information available today.
3 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 3 3
Agenda
1 Overview
3 2015 financial performance
2 Key 2016 events
Overview
5 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 5 5
Ipsen, an international specialty pharma company
~80%
~20%
Q1 2016 sales by segment
Primary
care
Q1 2016 sales by geography
39% 32%
15% 14%
Europe
G5
Developed
RoW
Emerging
markets
US
Specialty
care
Consolidating US footprint
1 France
3 China
4 Germany
2 US
5 Italy
Top 5 affiliates
Note: ROW: Rest of World
One of the largest emerging market presence in the industry
6 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 6 6
A refocused strategy to sustain high sales and profit growth
Note: GI:Gastrointestinal; OTx:Dual channel approach (Rx/OTC); NET: Neuroendocrine tumors
Lead
Reinforce
Explore
Specialty care
NET
Spasticity
Dysport®
aesthetics
Urology-oncology
Adult endocrinology
GI/orphan cancers
Niche strategy
Optimize
Diversify
Expand
Primary care
Smecta®
Forlax®
Tanakan®
Adjacent GI
Probiotics
Geographies
Move to OTx commercial model
Key 2016 events
8 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 8 8
2016 roadmap
Note: OTx: Dual channel approach (Rx/OTC); NET: Neuroendocrine tumors
Position Somatuline® as a leader in NET
and secure Dysport® spasticity launch
Prepare the commercial launch of Cabozantinib
for the treatment of Renal Cell Carcinoma in Europe
Implement new Primary Care OTx model, notably in China
Continue Business development to replenish pipeline
and complement marketed product portfolio
Implement new corporate governance model
9 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 9 9
10
10
29
5
5
15
63
78
122
Tanakan
Forlax
Smecta
Hexvix
Increlex
Nutropin
Dysport
Decapeptyl
Somatuline®
®
®
®
®
®
®
(3.8%)
(16.9%)
+36.3%
(4.2%)
(4.1%) ®
+6.8%
+3.6%
Q1 2016 sales driven by strong Somatuline® performance
Drug sales – Q1 2016 in million euros – % excluding foreign exchange impact
France: (3.6%)
International: (13.7%)
+11.5%
Group sales
€362.0m
+4.7%
Primary care
€73.9m
(11.0%)
Sp
ec
ialt
y c
are
P
rim
ary
ca
re
® Specialty care
€288.1m
+9.7%
(4.6%)
Decapeptyl® and Smecta® impacted by stocking effects, notably in China
Dysport® aesthetics impacted by stocking effects through Galderma partnership
10 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 10 10
Exclusive license agreement with Exelixis for Cabozantinib, with key indication in Renal Cell Carcinoma (RCC)
Exclusive global licensing and commercialization rights (ex North America & Japan)
Renal Cell
Carcinoma
Filed in 2nd line
Hepatocellular
Carcinoma
Ph3 in 2nd line
Key indications
Marketed
110,000 patients 60,000 patients 1,500 patients
European incidence
Potential development in further indications
Medullary
Thyroid Cancer
Marketed
11 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 11 11
Cabometyx®, first therapy to show 2L RCC clinically meaningful improvement in OS, PFS and ORR
Standard of care: TKIs
Renal Cell Carcinoma
(1) Motzer RJ et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III trial – (2) FDA Package Insert – (3) vs Everolimus – (4) as published in the NEJM. Note : mTOR: Mammalian Target Of Rapamycin; ORR:
Objective Response Rate; OS: Overall survival, PFS: Progression Free Survival; RCC: Renal Cell Carcinoma; TKI : Tyrosine Kinase Inhibitors
Approved therapies
1st line
TKIs
mTOR inhibitors
New entrants
Cabometyx® Opdivo®
PFS
2d line
OS
ORR
7.4
Value(2) HR
RCC 2nd line treatment paradigm shift from PFS to OS
0.58 3.6
21.4 0.66 4.9 25.0 0.73 5.4
Value(2) HR (3) (3)
4.9 0.33 3.0
Value(1) HR
2% 25%(4) 21%(4)
FDA-approved November 23rd, 2015
4.6 0.88 0.2
20 pts 16 pts
14.8 0.87 0.4
2 pts
Afinitor®
FDA-approved April 25th, 2016
12 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 12 12
Accelerate specialty care growth in the next 5 years with a 4th pillar added
to Ipsen Specialty portfolio
Acquire a potential best in class derisked asset in attractive niche RCC
with solid scientific data triggering treatment paradigm shift
RCC: Renal Cell Carcinoma
Completion of a global oncology therapeutic footprint (US and Europe)
Reinforce Ipsen portfolio in niche oncology with potential for further
development in other indications
Strong rationale for Cabozantinib in-licensing
13 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 13 13 MTC: Medullary Thyroid Cancer, RCC: Renal Cell Carcinoma
Cabozantinib, deal terms and impact on Ipsen operations
Operations
Upfront: $200m
Regulatory: up to $110m ($60m for RCC and $50m for HCC indications)
Commercial: up to $545m
Milestones
Royalties Tiered up to 26% on net sales
Transfer of MTC Market Authorization in H2 2016 and RCC launch starting
in 2017
Significant commercial investment
Cost containment and project prioritization initiatives to minimize impact of
2016 - 2018 investment period
14 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 14 14
Specialty care sales
Core Operating margin Around 21% of sales
Growth > 10.0%, year-on-year
Primary care sales Slight growth, year-on-year
2016 financial objectives
Including a negative impact of: • ~150 basis points resulting from the investment required to
prepare the commercial launch of Cabozantinib for the treatment of Renal Cell Carcinoma in Europe
• ~100 basis points from foreign exchange rates
At constant currency
At constant currency
15 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 15 15
Update of 2020 financial outlook
2015 2020E
Group sales Core Operating margin
> 7%
22.3%
> 26%
2015 2020E
>+370bps
€1.4bn
> €2.0bn
Specialty
care
Specialty
care
Primary care
>8%
[2% to 4%]
CAGR
Primary care
2020 Sales target increased to reflect Cabozantinib sales contribution
2020 Profitability target confirmed
2015 financial performance
17 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 17 17
Specialty Care - Drug sales(2)
Core Operating margin (as percentage of sales)
≥ 22.0%
Primary Care - Drug sales(2)
≥ 14.0%
[-3.0% ; 0.0%]
22.3%
+14.4%
-1.1%
2015
guidance(1)
2015
actuals
2015 sales and Core Operating Income strong performance in line with market guidance
(1) Revised on 31 July 2015 – (2) Year-on-year sales growth at constant currency
18 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 18 18
Turnaround of the US platform, with high potential for growth
(1) Restated for Increlex® supply interruption Note: All growth rates at constant currency; AUL: Adult Upper Limbs; NET: Neuroendocrine tumors;
US affiliate sales growth(1) Somatuline® US sales growth
2013 2014 2015
11.5%
31.2%
64.9%
2013 2014 2015
18.6% 28.6%
111.9%
US operations profitable in 2015, ahead of plan
Renewed management and Salesforce (NET & spasticity)
Successful Somatuline® NET launch and preparation of Dysport® AUL spasticity launch
Strong Dysport® aesthetics performance from Galderma
1
2
3
19 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 19 19
Strong Somatuline® 2015 performance, driven by successful NET launch
247
288
402
2013 2014 2015
+16.8%
Business update
3-year growth 2015 performance
Geographic distribution (2015)
Overall acceleration of growth due to NET
global launch
Strong growth in North America, up 112% with
positive price impact
Double digit growth in Europe, notably in
Germany, the UK, Poland and France
42% 28% 18% 12%
G5(1)
Emerging markets(2) United States
Developed RoW
(1) France, Germany, UK, Italy, Spain – (2) Notably includes China, Russia and Brazil Note: all variations at constant exchange rate; NET: Neuroendocrine tumors;
+34.2%
US: Ipsen present in >1 000 accounts,
including all 25 major reference centers
Europe: GEP NET approval granted by all
European countries
Increased penetration across geographies
20 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 20 20
Somatuline® accelerated NET penetration in the US and Europe
Source: IMS MIDAS + Symphony Healthcare. (1) G5: France, Germany, UK, Spain, Italy – (2) Market share in volume Note: Market definition = long-acting SSAs; NET: Neuroendocrine tumors;
Somatuline® US quarterly data, all
indications
0
2
4
6
8
10
12
14
0
10
20
30
40
Q1 2014 Q3 2014 Q1 2015 Q3 2015 Q1 2016
Somatuline® Europe G5(1) quarterly
data, all indications
20
25
30
35
40
45
0
10
20
30
40
Q1 2014 Q3 2014 Q1 2015 Q3 2015 Q1 2016
Ipsen reported sales ($m) Market share(2) (%) Ipsen reported sales (€m) Market share(2) (%)
Somatuline® capturing majority of new patients in US and Europe
Increased number of switched patients
44.2% 12.8%
21 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 21 21
Dysport® 2015 performance driven by aesthetics
242 255
280
2013 2014 2015
+8.6%
Business update
3-year growth 2015 performance
Geographic distribution (2015)
Strong Galderma performance in aesthetics in
a solid underlying market growth
Solid performance in emerging markets,
notably in Russia, Brazil and Australia
Strong US Q4 driven by aesthetics &
spasticity launch
18% 12% 25% 45%
+9.7%
(1) China, India, South Korea (and Indonesia under certain conditions) – (2) France, Germany, UK, Italy, Spain – (3) Notably includes China, Russia and Brazil
Note : all variations at constant exchange rate; AUL: Adult Upper Limbs
Q3 US launch of Dysport® in AUL spasticity
and sales force build-up
Setup of European business unit for
therapeutics
Galderma partnership expanded to key Asia
Pacific territories(1)
G5(1)
Emerging markets(2) United States
Developed RoW
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Dysport® US market share in aesthetics increasing since Galderma takeover
Botox®
market
share (%)
Source: GuidePoint - Filler & Toxin Panel
Dysport® US market share in excess of 20% thanks to Galderma’s commercial push
30%
40%
50%
60%
70%
80%
90%
0%
5%
10%
15%
20%
25%
30%
35%
Feb 10 Jun 10 Oct 10 Feb 11 Jun 11 Oct 11 Feb 12 Jun 12 Oct 12 Feb 13 Jun 13 Oct 13 Feb 14 Jun 14 Oct 14 Feb-15 Jun-15 Oct-15
~73%
~22%
~5%
Botox®
Dysport ®
Xeomin®
Dysport® /
Xeomin®
market
share (%)
23 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 23 23
Positive Decapeptyl® growth in 2015, despite emerging markets headwind
299
317
334
2013 2014 2015
+6.5%
3-year growth
Business update
2015 performance
Geographic distribution (2015)
Q4 growth recovery in China after first 9
months affected by market slowdown and
pricing pressure
Price pressure across Europe and Algeria
High penetration in Spain with favorable share
of voice to competitors
G5(1) Developed RoW Emerging markets(2)
48% 9% 43%
+1.3%
(1) France, Germany, UK, Italy, Spain – (2) Notably includes China, Russia and Brazil Note: all variations at constant exchange rate
Launch of 3-month subcutaneous formulation
in Europe from July 2015
Progress on potential combination in breast
cancer
Increased commercial focus in China with
dedicated sales force per indication
24 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 24 24
Primary care resilient thanks to international market growth
354 328 330
2013 2014 2015
(4.8)%
Business update
3-year growth 2015 performance
Geographic distribution (2015)
Smecta® sales impacted by new
manufacturing setup in Algeria and destocking
in distribution and price pressure in China
Tanakan® facing out of pocket market
slowdown and tough competition in Russia
and France
Solid performance of Etiasa® in China and
Fortrans® notably in Russia
30% 5% 65%
(1) France, Germany, UK, Italy, Spain – (2) Notably includes China, Russia and Brazi Note: all variations at constant exchange rate; OTx:Dual channel approach (Rx/OTC)
G5(1) Developed RoW Emerging markets(2)
(1.1)%
Start of Tanakan® local production in Russia
Launch of Smecta® ready-to-use (liquid) and
Strawberry taste in Q4 2015 in France
Accelerated switch of China primary care
model to OTx with recruitment of 100
additional reps in 2016
25 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 25 25
in m€ FY 2015 FY 2014 Change %
Change
Change at
constant FX
Net sales 1,443.9 1,274.8 +169.1 +13.3% +10.4%
Other revenues 76.3 57.6 +18.7 +32.5%
Revenue 1,520.2 1,332.4 +187.8 +14.1%
Cost of goods sold (336.8) (310.0) -26.8 +8.7%
R&D expenses (192.6) (186.9) -5.7 +3.0%
Selling expenses (541.4) (464.1) -77.3 +16.7%
G&A expenses (122.9) (111.2) -11.7 +10.4%
Other core (4.1) 0.3 -4.4 NA
Core Operating income 322.5 260.6 +61.9 +23.8%
Core Operating margin 22.3% 20.4% +1.9 pt
P&L - From sales to Core Operating Income
Operating leverage driving margin expansion
26 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 26 26
50%
17%
10%
5%
18%
Ipsen exposure to foreign currencies
EUR
USD
GBP
CNY
Other(1)
(1) Includes RUB, BRL, AUD, PLN and other currencies
Evolution of major currencies vs. EUR 2015 sales exposure by currency
2015 sales growth benefited from strong USD, CNY and GBP appreciation versus euro
2016 sales to be impacted by depreciation of emerging countries currencies (BRL, CNY, RUB)
€1,443.9 million
…
Foreign Currency policy
Average rates change (2015vs. 2014)
19.9% 17.6%
11.1%
-25.3%
-15.4%
USD CNY GBP RUB BRL
Global FX exposure mitigated by cost base in local currency and hedging of key currencies
27 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 27 27
FY 2014 FY 2015
COGS (€m)
24.4% 23.6%
R&D (€m)
Selling expenses (€m)
FY 2014 FY 2015
+16.7%
G&A (€m)
+8.7%
541.4
464.1
336.8
+3.0%
192.6
186.9
+10.4%
8.7% 8.5%
122.9
111.2
Drivers for operating cost evolution
Note: All ratios in percentage of sales; NET: Neuroendocrine tumors
36.4% 37.5%
Positive mix effect, manufacturing efficiencies Impact of TasQ studies discontinuation
Support functions, variable compensation Impact of US investment (NET, spasticity)
FY 2014 FY 2015
24.3% 23.3%
310.0
FY 2014 FY 2015
14.7% 13.3%
28 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 28 28
in m€ FY 2015 FY 2014 Change %
Change
Net sales 1,443.9 1,274.8 +169.1 +13.3%
Core Operating income 322.5 260.6 +61.9 +23.8%
Core Operating income margin 22.3% 20.4% +1.9 pt
Other non core (7.2) (9.2) +2.0
Restructuring costs (6.7) (21.9) +15.2
Impairment gain / (losses) (64.6) (8.0) -56.6
Operating income 244.0 221.4 +22.6 +10.2%
Financial result (6.4) (15.1) +8.7
Income taxes (49.8) (53.8) +4.0
Share of profit from JV 2.5 1.9 +0.6
Discontinued operations 0.5 (0.5) +1.0
Consolidated net profit 190.7 154.0 +36.7 +23.8%
Consolidated profit margin 13.2% 12.1% +1.1 pt
EPS – fully diluted (€) 2.30 1.87 +0.43 +23.0%
Core EPS – fully diluted (€) 2.78 2.22 +0.56 25.2%
P&L - From Core Operating Income to EPS
Consolidated net profit up 24% after TASQ impairment charge and exceptionally low tax rate
29 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 29 29
180 214
+290
-61
-58
-15 -70
-29 -39
+16
In million euros
Operating
cash
flow(1)
31 Dec 2015 31 Dec 2014
Change in
working
capital(1)
Solid cash generation to finance capex, BD and return to shareholders through dividend & share buy-back
Dividends
BD &
milestones Closing
cash
Capex
Opening
cash
Other
Closing cash up €34m vs 2014
Strong cash generation to self-finance acquisitions
Free cash flow: €156m
(1) Excluding milestone amortization
Restructuring
Share
Buyback
30 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – 2016 Healthcare Conference 30 30
Proposal to maintain a dividend of €0.85 per share to support BD investment
Group sales up 10.4% at constant currency
Strong Core Operating Income margin of 22.3%(1)
Consolidated net profit of €190.7m, up 23.8% year-on-year
Fully diluted core EPS of €2.78, up 25.2% year-on-year
Closing cash balance of €214m, up 19%
Key financial takeaways
(1) In percentage of sales