Titre général de la présentation · JP Morgan 34th Annual Healthcare Conference. 2 Ipsen Goldman...

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.


Agenda

Key takeaways

1 Overview

Specialty care

Primary care

2

3

4

Overview


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


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


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


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


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


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%

Présentateur

Commentaires de présentation


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


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


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®


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


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%


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)


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


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


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


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


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


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


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

Titre général de la présentation · JP Morgan 34th Annual Healthcare Conference. 2 Ipsen Goldman...

Documents

Transcript of Titre général de la présentation · JP Morgan 34th Annual Healthcare Conference. 2 Ipsen Goldman...