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IPSEN pour nom de la société - 07/04/2011 / page 1
Marc de Garidel – Chairman and CEO
Ipsen JP Morgan 34th Annual Healthcare Conference
2 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – JP Morgan 34th Annual 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 – JP Morgan 34th Annual Healthcare Conference 3 3
Agenda
Key takeaways
1 Overview
Specialty care
Primary care
2
3
4
Overview
5 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – JP Morgan 34th Annual Healthcare Conference 5 5
Ipsen, an international specialty pharma company
~77%
~23%
9M 2015 sales by segment
Primary care
9M 2015 sales by geography
38% 38%
10% 14%
Europe G5
Developed RoW
Emerging markets
US
Specialty care
Consolidating US footprint
1 France
2 China
4 Germany
3 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 – JP Morgan 34th Annual Healthcare Conference 6 6
Ipsen’s recent share price evolution reflects improving sales and profitability
Note COI: Core Operating Income. 2010 – 2013 figures have been restated to be comparable to current COI format (1) At constant exchange rate
10%
12%
14%
16%
18%
20%
22%
24%
26%
28%
30%
0%
2%
4%
6%
8%
10%
12%
2011 2015E
Sales growth and COI margin evolution Share price performance
0
10
20
30
40
50
60
70
2011 2015
≥ 22.0%
≥ 9.5%
Sales growth(1) YoY (%)
Sales growth
COI margin
COI margin (in % of sales) in €
2015 guidance showing strong sales and profitability momentum
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A refocused strategy within specialty and primary care
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
8 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – JP Morgan 34th Annual Healthcare Conference 8 8
2020 organic sales and profitability targets
(1) In percentage of sales (2) CAGR: Compound Annual Growth Rate at constant currency
2014 2020
Group organic sales Core Operating margin(1)
[6% to 8%]
20.4%
> 26%
2014 2020E
>+560bps
E
€1.3bn
[€1.8bn to €2bn]
Potential Business Development to complement €1.8bn to €2.0bn organic sales target
Specialty care Specialty care
Primary care Primary care
[7% to 9%]
[2% to 4%]
CAGR(2)
Reach global leadership in Neuroendocrine tumors
10 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – JP Morgan 34th Annual Healthcare Conference 10 10
1st line : Somatuline®, a best-in-class treatment for tumor and symptom control
Note: IP: Intellectual Property; NET: Neuroendocrine Tumor
Improved technology with retractable needle Enhanced, prefilled and ready-to-use, low-volume syringe Full-dose delivery with no reconstitution requirements
Best-in-class
1
IP
2
Life Cycle Management
3
Autogel® formulation running until 2015 in Europe, 2020 in the US US Orphan Disease exclusivity for GEP NET until 2021 Low risk of generic competition on current formulation
FDA discussion for symptom control in the US 3-month formulation under development Potential expansion towards lung NET
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1.09
5.8
1973 2010
Rapid expansion of US SSA NET market, with still a significant growth reservoir
US NET incidence(1)
Per 100 000
Current SSA NET market of [$600m-$800m]2 in the US
Note : GEP-NET: Gastroenteropancreatic neuroendocrine tumors ; SSA: Somatostatin analog (1) Surveillance, Epidemiology, and End Results (SEER) Program SEER*Stat Database: Incidence – SEER 18 Regs
Research Data, Nov 2011; (2) Ipsen estimates
US NET prevalence(1)
35 / 100 000
US NET population ~ 120 000
Watch & Wait
~20%
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Somatuline® accelerated NET penetration in the US and Europe
Source: IMS MIDAS + Symphony Healthcare. (1) G5: France, Germany, UK, Spain, Italy; (2) Market share in volume Note: Market definition = long-acting SSAs
Somatuline® US quarterly data, all indications
1
3
5
7
9
11
0
4
8
12
16
20
24
28
32
36
Q3 2013 Q1 2014 Q3 2014 Q1 2015 Q3 2015
Somatuline® Europe G5(1) quarterly data, all indications
20
25
30
35
40
45
7
17
27
37
Q3 2013 Q1 2014 Q3 2014 Q1 2015 Q3 2015
Ipsen reported sales ($m) Market share(2) (%) Ipsen reported sales (€m) Market share(2) (%)
Significant 2015 market share gain in the US (~5 points) and in Europe (~3 points)
Good US penetration of Somatuline® present in >1 000 accounts
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2d line : Telotristat etiprate for NET symptom control
NET: Neuroendocrine Tumor ; SSA: Somatostatin analog; TPH: Tryptophan hydroxylase
Telotristat etiprate
Novel oral treatment for carcinoid syndrome not adequately controlled under SSA
Agreement
Exclusive commercialization rights ex US & Japan
Lexicon eligible to receive up to $145m, incl. $23m upfront payment
Telotristat etiprate reduces peripheral serotonin production by
inhibiting TPH enzyme
Filing expected mid 2016 in Europe
Clinical results
Statistically significant reduction from baseline at 250 mg & 500 mg doses vs. placebo in the average number of daily bowel movements over the 12-week study period
29% and 35% reduction at week 12, vs 17% for placebo
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Phase 3 to start end of 2016
Imaging: OPS202, a new generation diagnostic agent for NET
Octreoscan® OPS202
Potential change in disease
management
FDA orphan drug designation
Potential to detect smallest
NET lesions
OPS202
68Gallium-labeled
somatostatin receptor
NET: Neuroendocrine Tumor
OPS202
Major improvement vs. current Octreoscan®
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Phase 1 to start in H1 2016
Peptide-Guided Radioisotope for PRRT
2nd line : OPS201 for tumor control
NET: Neuroendocrine Tumor; PRRT : Peptide Receptor Radionuclide Therapy; SSA: Somatostatin analog
OPS201 Best in class PRRT with a wider therapeutic window for NET patients progressing under SSA
Tumor cell-selective internal peptide receptor radionuclide therapy with 90Y or 177Lu
Superior binding behavior of Antagonistic Somatostatin Analogs
Step 1 Step 2 Step 3
Tumor Cell
Peptide Analog
Chelator Radioisotope
Peptide Receptor on Surface of Tumor Cell Agonist SSTR2 Antagonist SSTR2
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Ipsen present at every level of NET treatment paradigm
In development Marketed
Symptom control (ex-US) 2nd line
(not SSA controlled)
1st line (SSA)
Tumor control
1st line (SSA)
2nd line
OPS202 (68Ga – Satoreotide )
Somatuline®
Telotristat (carcinoid syndrome)
Somatuline®
OPS201 (177Lu – Satoreotide)
Imaging Monitoring
Diagnosis
Note: NET: Neuroendocrine Tumor ; SSA: Somatostatin analog; Ga: Gallium; Lu: Lutetium
Reach global leadership with Dysport® in spasticity and aesthetics
18 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014 Ipsen – JP Morgan 34th Annual Healthcare Conference 18 18 Source: LA Merie Publishing; Evaluate Pharma Botox Annual Report
US ROW US ROW
2014 Botulinum toxin market : ~$3.0bn
Botulinum toxin market growth throughout 2025
CAGR in Therapeutics : +10% CAGR in Aesthetics: +9%
Main aesthetic markets : US, Europe, Brazil and Russia
Main competitors: Botox® (Allergan), Xeomin® (Merz)
Worldwide neurotoxin market
Aesthetic Therapeutic
~$1.4 bn ~$1.6 bn
Dysport®, a well-positioned product in fast-growing market
2014 market figures Market metrics
49% 51% 45%
55%
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AUL spasticity
Ex North America
In development Current indications
North America
Dysport® present in all major therapeutic indications in Europe, to be completed in the US
Note: ALL: Adult Lower Limbs; AUL: Adult Upper Limbs; PLL: Pediatric Lower Limbs; PUL: Pediatric Upper Limbs
Cervical Dystonia
ALL spasticity
PUL spasticity
PLL spasticity
Blepharospasm
Hemifacial spasm
Cervical Dystonia
Hyperhydrosis
Adult Spasticity
Cerebral Palsy (pediatric)
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New spasticity launches to open significant market opportunities in the US
US addressable market increasing to ~ $450m
Today
Cervical Dystonia
Tomorrow’s potential
AUL spasticity
PLL spasticity
ALL spasticity
Expected launch 2016 (First mover)
Expected launch 2017
PUL spasticity Expected launch > 2018
~ $300m
Note: ALL: Adult Lower Limbs; AUL: Adult Upper Limbs; PLL: Pediatric Lower Limbs; PUL: Pediatric Upper Limbs
Launched 2009
Launched 2015
~ $150m
Addressable market
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Successful partnership with Galderma for Dysport® aesthetics
December 2015: geographic expansion to China, India, South Korea, Indonesia1
Market share gain in fast growing market
Regaining market share thanks to Galderma’s commercial push
Double digit growth despite challenging environment
Scope: commercialization and R&D, including respective liquid formulations
2
Partnership Key market performance
Territories: > 75% of world aesthetics market including US, Canada, Europe, Brazil and Australia
1
(1) Indonesia under certain conditions
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New generation toxins
Ipsen investing in its toxin pipeline to ensure mid-term leadership position
Liquid toxin
Life cycle management on
current formulation
Syntaxin development programs Recombinant technology Long-acting and short-acting toxins (first program in men in 2016) TSI (Targeted Secretion Inhibitors)
Dysport® liquid solution Cervical Dystonia, expected filing Q4 2016 in Brazil and Europe Glabellar lines currently in phase 3 (Galderma) Galderma’s liquid toxin QM-1114 in phase 2
Glabellar lines phase 3 in China Potential in other spasticity-related pathologies NDO (Neurogenic Detrusor Overactivity) Sialorrhea
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EU & Brazil
NET
Spasticity
Phase 1 Phase 2 Phase 3
R&D pipeline Regulatory
Urology-Oncology
Somatuline® - NET symptoms
Dysport® - ALL Spasticity
OPS201 - Lu Satoreotide
Somatuline® Autogel® PRF
Dysport® - PUL Spasticity
Dysport® - NDO
MCNA
Dysport® NG – Cervical Dystonia
BN82451B – Huntington disease
Dysport® NG – Glabellar Lines
VSN16R – Multiple sclerosis
Dysport® - PLL Spasticity
Pre-clinical
OPS202 - Ga Satoreotide
LX1032 - Telotristat etiprate NET
Indication
Decapeptyl® - SC 3-month
EU
US
US
EU
US
EU
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Strong balance sheet and financial discipline to support business development ambition
Early stage deals to replenish pipeline
Late stage deals to leverage commercial structure
Focus on current specialty care segments, with potential
diversification into orphan/GI oncology
Targets
€600m-€800m envelope for bolt-on acquisitions
Note: GI:Gastrointestinal
Primary care
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New primary care Otx/GI strategy to return to growth
Note: GI:Gastrointestinal, OTx:Dual channel approach (Rx/OTC)
Acceleration of OTx Strategy for Smecta®
Expansion of GI franchise
Investment to recruit 100 reps in China
New launches in Q4 2015 in France o Smecta® stick (ready-to-use) o Smecta® strawberry
Potential business development focused on global and local OTx/GI opportunities
Adjacent GI segments including probiotics
New geographies
Key takeaways
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Key takeaways
Note: GI:Gastrointestinal, OTx: Dual channel approach (Rx/OTC)
Ipsen well-positioned to reach leadership in specialty care niche markets and primary care GI/OTx
Business development to complement pipeline and organic growth with bolt-on acquisitions
Ipsen entering into a new sales and profit growth phase thanks to Somatuline® and Dysport® launches
Ipsen committed to deliver superior shareholder value
Thank you