Ipsen Investor Day. 2 July 2015

Transcription

1 Ipsen Investor Day 2 July 2015

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. 2 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

3 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 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

4 Agenda Marc de Garidel Chairman and Chief Executive Officer

5 Agenda for the day 14:00-14:25 14:25-15:45 15:45-16:00 16:00-16:10 Introduction Group strategy Q&A session Coffee break Marc de Garidel, CEO Christel Bories, Deputy CEO 16:10-16:50 R&D strategy Claude Bertrand, CSO 16:50-17:10 Financials Aymeric le Chatelier, CFO 17:10-17:15 Conclusion Marc de Garidel, CEO 17:15-17:30 Q&A session 5 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

6 Introduction Marc de Garidel Chairman and Chief Executive Officer

7 The 2011 strategy initiated a period of significant progress Increase Focus Invest to Grow Leverage Footprint Endocrinology/NET Neurology Urology-Oncology Peptides Toxins Business development United States Emerging Markets Europe 2020 ambition More than double sales (1) More than triple EBIT (2) (1) At constant exchange rate vs Sales: 2020 sales of 2 billion to 2.5 billion - 7 Ipsen Investor Day 2 July 2015 (2) vs Core Operating Income: 7 Goldman Sachs 35th Annual Global Healthcare Conference EBIT June prior 2014 to purchase accounting recordings and non recurring elements: 2020 EBIT of 500 million to 600 million

8 which led the Group to become a global specialty care company Sales by segment Sales by geography Specialty care ~65% ~35% Primary care 2010 Europe G5 50% 32% 5% 13% Emerging markets US RoW Specialty care ~75% ~25% Primary care Q Europe G5 39% 14% 39% 9% Emerging markets RoW US 8 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

9 Specialty care, the growth engine over Specialty care (SC) ~ 700m Other SC +8% +3% +4% Specialty care ~ 950m Other SC Growth drivers China +9% Aesthetics +14% NET CAGR (1) Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) Compound Annual Growth Rate at constant currency

10 Key achievements Strengthened R&D 8 Phase III programs delivered Consolidation in toxin research (Syntaxin/Harvard partnership) Boston peptide platform revamped FDA approval of Somatuline as first line treatment in NET Reinforced BD capacity Galderma expanded partnership Telotristat etiprate/ Canbex option/ OctreoPharm Sciences Transformation Inspiration exit with OBI-1 sale to Baxter Restructuring of French primary care and Dysport US operations Management team reinforced Efficiency and cost control efforts 10 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: NET: Neuroendocrine tumors

11 Turnaround of the US platform, with high potential for growth Sales growth (1) ~$1 billion addressable market 55.3% ~$100m Acromegaly 11.5% 31.2% NET ~$600m ~$300m Spasticity Q Key accomplishments Somatuline unique first-line label in NET granted by FDA Reinforcement of Dysport organization for Q spasticity launch Build up of 100 people oncology sales force for NET launch Profitability expected in Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: GEP NET: Gastroenteropancreatic neuroendocrine tumors (1) Restated for Increlex supply interruption

12 Business development strategy starting to pay off with 4 deals signed in the last 12 months Galderma (aesthetics) Agreement expansion July m milestones received Telotristat (NET) In-licensing of global rights (ex US/Japan) October 2014 $145m total milestones Canbex (Spasticity) Call option for company acquisition (1) February m total milestones (incl. 6m option) OctreoPharm (NET) Company acquisition May m total milestones 12 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) Upon completion of the Phase IIa study of VSN16R Note: NET: neuroendocrine tumor

13 achievements reflected in share price performance Share price evolution (Jan June 2015) : Reorganization period : Growth period Inspiration exit decision IPSEN +121% Stoxx Pharma (1) +108% SBF % Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) STOXX 600 Europe TMI Healthcare

14 : A refocused strategy within specialty and primary care Global leadership in targeted diseases Focus on GI/OTx 14 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: GI:Gastrointestinal, Otx:Dual channel approach (Rx/OTC)

15 Specialty care strategic focus Reach global leadership in niche therapeutic areas NET Spasticity Aesthetics (through Galderma) strengthen positions in historical therapeutic areas and explore new targets Uro-oncology Adult Endocrinology GI/Orphan oncology 15 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: NET: Neuroendocrine tumors, GI:Gastrointestinal

16 Primary care: focus on GI/OTx Maximize existing business with OTx shift Expand into new GI areas Expand into new geographies 16 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: GI: Gastrointestinal, OTx: Dual channel approach (Rx/OTC)

17 Strong Business development focus to complement organic growth Therapeutic areas Geographies Late stage deals Early stage deals NET Spasticity Uro-oncology GI/Orphan oncology Primary care US Europe Emerging markets 17 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: GI: Gastrointestinal

18 2020 outlook showing strong sales growth and profitability momentum Group organic sales Core operating income margin (1) [+6% to +8%] CAGR >+560bps 1.1bn ~+4% CAGR 1.3bn [ 1.8bn - 2bn] 18.9% +130bps 20.4% >26% E E Ipsen to outperform industry growth 18 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) In percentage of sales

19 Group strategy Christel Bories Deputy Chief Executive Officer

20 A refocused strategy within specialty and primary care Global leadership in targeted diseases Focus on GI/OTx 20 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: GI:Gastrointestinal, Otx:Dual channel approach (Rx/OTC)

21 «Own the disease» business model to achieve leadership «Own the disease» business model Key features of category leaders Focus on few disease areas with high R&D expertise and strong innovation Be present at different stages of the treatment pathway Offer a range of differentiated products, devices, and services around treatment Cover the full value chain from R&D to commercialization Customized solutions combining scientific and marketing perspectives Strong relationships with key stakeholders (specialists, KOL, payers...). Partner of choice for new developments Strong knowledge of disease mechanism resulting in improved clinical PoS Credible partner for BD and alliances 21 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: KOL: Key Opinion Leaders POS: Probability of Success

22 Ongoing transformation to adapt company profile to fast-changing environment 1 France and US restructuring to adapt sales force now completed 2 New organization and commercial model 3 Ongoing initiatives to improve efficiency across all departments Ipsen to become an agile and flexible entity outperforming industry 22 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

23 Deep transformation process involving all parts of the company Specialty Care operations Commercial optimization Primary care GI & OTX focus Franchises Focused portfolio management & launch excellence Ipsen s transformation path Open innovation R&D Flexibility Delivery Focus and POC centric Open innovation Development Excellence Business Development Focused Portfolio addition Manufacturing Process robustness Quality and efficiency Support Functions Business support, Simplification, cost control 23 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

24 NeWayS : 10 commercial initiatives to optimize and sustain growth in specialty care Oncology Boost European Business Units Therapeutic area optimization Aesthetics Centre of Excellence Geographic Clustering Geographic optimization Medical Optimization NeWayS Purchasing excellence Additional sales Decapeptyl Optimization New Territories Expansion Cost efficiency Non Core Indications Export Acceleration Combination 24 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

25 Specialty care

26 Reach global leadership in targeted diseases, reinforce position in historical areas, and explore new targets OWN THE DISEASE Global leadership Areas to reinforce NET Spasticity Neurotoxin for aesthetics (Galderma) Prostate cancer Bladder cancer Adult endocrinology New potential targets GI Oncology Orphan Oncology 26 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: NET:Neuroendocrine tumors, GI:Gastrointestinal

27 Focus on Neuroendocrine tumors (NETs) Global leadership NET OWN THE DISEASE 27 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: NET:Neuroendocrine tumors, GI:Gastrointestinal

28 Neuroendocrine tumors in a nutshell Rare, heterogeneous, slow-growing tumors (1) Arise from cells with neuroendocrine origin (1) Can arise from most organs, commonly (1) : Gastrointestinal tract and pancreas Endocrine organs Lung 2 US and Europe GEP NET prevalence: ~ patients Credits : 1 BSIP, Estiot; 2 Pasieka; 3 BSIP, Vero/Carlo; Science Photo Library US NET market > $600m (2), currently underserved Europe NET market ~$400m (2) 28 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Source: (1) Buchanan KD Gastroenterol Today 2003; 13: 2 3 (2) Ipsen estimates

29 Beyond Somatuline, Ipsen made two acquisitions to address the whole NET treatment paradigm Imaging Diagnosis Monitoring SOMscan Symptom control (ex-us) 1 st line (SSA) 2 nd line (not SSA controlled) Somatuline Telotristat (carcinoid syndrome) Tumor control 1 st line (SSA) 2 nd line Somatuline SOMther 29 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 In development Marketed Note: NET:Neuroendocrine Tumor SSA: Somatostatin analog

30 Somatuline, the first SSA approved for tumor control of GEP-NET in Europe and US COMPETITOR COMPETITOR Midgut Tumor treatment Pancreatic Hindgut Symptom treatment 30 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: GEP NET:Gastroenteropancreatic neuroendocrine tumor, SSA: Somatostatin analog

31 Somatuline sales and market share accelerating in US and Europe Somatuline US quarterly data, all indications Somatuline Europe G5 (1) quarterly data, all indications sales ( m) market share (%) sales ( m) market share (%) Q Q Q Q Q Q Q Q Q Q Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Source: IMS MIDAS, long-acting SSA market only (1) G5: France, Germany, UK, Spain, Italy

32 Xermelo (telotristat etiprate): a novel oral treatment for NET symptom (1) control currently in Phase 3 SSA add-on therapy for symptomatic patients Strong Phase 2 data with >40% reduction in bowel movements (2) Phase 3 results expected in Q Expected launch in 2017 in Europe Estimated peak sales > 50m 32 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: NET: Neuroendocrine tumors, SSA: Somatostatin analog (1) Carcinoid syndrome (2) at week vs placebo

33 SOMscan : a new generation imaging agent for NET Octreoscan SOMscan 68 Gallium-labeled somatostatin receptor antagonist suitable for positron emission tomography Major improvement vs. current Octreoscan Potential to change patient diagnostic and management 33 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: NET: Neuroendocrine tumors

34 SOMther : potentially best in class PRRT with a wider therapeutic window for NET patients progressing under SSA Lutetium combined with SSTR2 antagonists for 2 nd line treatment of NET patients progressing under SSA To be manufactured and distributed inclusive of peptide and radionuclide Currently in preclinical development, launch expected beyond Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: PRRT: Peptide Receptor Radionuclide Therapy, SSA: Somatostatin Analog

35 NET treatment paradigm still offers room for expansion 1 Somatuline life cycle management OTHER DIAGNOSIS Imaging 2 3 Business development Patient-targeted approaches and services Symptom Control Tumor control COMORBIDITIES SERVICES TO PATIENTS OTHERS PALLIATIVE CARE Current presence Room for expansion 35 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: NET: Neuroendocrine tumors

36 Focus on spasticity Global leadership Spasticity OWN THE DISEASE CONCEPT 36 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: NET:Neuroendocrine tumors, GI:Gastrointestinal

37 Spasticity to remain the largest segment of the fast-growing therapeutic toxin market Toxin therapeutic market by indication Other Blepharospasm 2% 7% Cervical dystonia 21% ~ 1.3 bn 41% Spasticity Chronic migraine Blepharospasm Other Cervical dystonia 15% 12% 2% 4% ~ 2.8 bn 43% Spasticity Chronic migraine 16% 14% Overactive bladder Overactive bladder 25% Therapeutic market CAGR : +11% 37 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Source: La Merie Publishing, Botulinium Neurotoxins, July 14 (unit: volume of procedures)

38 Dysport to become a global differentiated toxin with full spasticity reach TODAY Restricted spasticity label TOMORROW Improved label No spasticity indication New indications Incomplete spasticity coverage Undifferentiated toxin Complete spasticity label Differentiated toxin (liquid, new toxins) 38 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: US spasticity indications are subject to approval by regulatory authorities AUL: Adult Upper Limb, PLL: Pediatric Lower Limb, ALL: Adult Lower Limb

39 Ipsen, a leading player in spasticity, catching up in the US 2014 Dysport market share in spasticity (ex US) Xeomin 14% Other 2% 34% Dysport Dysport therapeutics, leader in several countries: Russia Brazil Botox 50% UK Ipsen boasts high market shares in its spasticity markets Ipsen currently absent in the US, spasticity launch planned in Q Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: Spasticity considered as the sum of Adult spasticity + Cerebral Palsy segments All market shares in value

40 Dysport, a great potential of differentiation in spasticity Greater duration of patient relief: Earlier onset of action Longer duration of action Only toxin to improve voluntary movements in entire limb (1) Key to help patients gain autonomy First toxin to show efficacy on Tardieu scale (2) Recognized as the best efficacy measure, specifically in spasticity 40 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) Dy : study 145 (AROM); Bx : NA; X : NA (2) Dy : study 145; Bx : NA; X : NA

41 Ipsen on track to succeed with US spasticity launch Best toxin to treat AUL spastic patients Only toxin to demonstrate improvement of voluntary movements Long relief period thanks to fast onset and long duration of action First Mover advantage in PLL Filing expected by end 2015 Potential full adult spasticity coverage with ALL Significant increase of US addressable market Spasticity sales force of ~20 reps to support launch 41 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: AUL: Adult Upper Limb, PLL: Pediatric Lower Limb, ALL: Adult Lower Limb

42 Dysport Solution, potentially the first liquid toxin on the market (ex-us) Enhanced safety and cost (no reconstitution) Ready-to-use Dysport Solution (liquid) Ability to reach more patients Full product range Dysport Solution to be filed in Cervical Dystonia in Europe and Brazil in H Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

43 Through LCM and Canbex acquisition, Ipsen well-positioned on the spasticity treatment paradigm 1 st line (oral muscle relaxants) Other pathologies in spastic patients 2 nd line (toxin) Dysport Dysport Solution Dysport (NDO, Sialorrhea) Other treatments Canbex (multiple sclerosis) In R&D pipeline Marketed 43 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: LCM: Life Cycle Management, NDO: Neurogenic Detrusor Overactivity

44 Canbex s deal option, a promising opportunity New Market Spasticity Diagnosed VSN16R use Existing Market Spasticity Treated (Use of current treatments limited by side effects) Expanded Disability Status Scale (Mobility Scale in MS) Progressive disability over time Higher tolerability allows VSN16R to be used in more patients and earlier in treatment 80% of the ~2 million MS patients worldwide suffer from some degree of spasticity 44 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: MS:Multiple sclerosis

45 Spasticity treatment paradigm still offers room for expansion DIAGNOSIS 1 st line (oral muscle relaxants ) 2 nd line (toxin) Other treatments Other pathologies in spastic patients (NDO, Sialorrhea) OTHERS FOLLOW-UP Current presence Room for expansion 45 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: BD: Business development, NDO: Neurogenic Detrusor Overactivity

46 Spasticity strategy key takeaways 1 Short / Mid term Focus Gain full spasticity reach (adult and pediatric) Launch in the US Leverage Dysport differentiation Differentiate First company to potentially launch liquid form in Europe and Brazil with Dysport Solution Invest Expand to new indications/ areas: R&D Long term Business development Innovate 2 New-generation differentiated toxins IP protection strategy 46 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: IP: Intellectual Property

47 Neurotoxin for aesthetics through Galderma alliance Global leadership Neurotoxin for aesthetics (Galderma) OWN THE DISEASE CONCEPT 47 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: NET:Neuroendocrine tumors, GI:Gastrointestinal

48 Aesthetics, a fast-growing market generating half of Dysport sales Dysport 2014 revenues (1) split (%) Aesthetics BonT market (2) ( billion) Aesthetics 50% 50% Therapeutics % Ipsen markets Dysport in Aesthetics: Directly in Russia and some Eastern European countries Via Galderma in Europe, USA, Brazil, Australia, Argentina, and Mexico Via other third parties in South America, Middle East, etc. Strong volume growth driven by: Emerging countries Favorable demographics Growing acceptance, in particular in men Price pressures due to: Emergence of lower priced Asian toxins Limited innovation 48 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) including Net Sales and royalties, (2) Ipsen estimate Note: BonT: Botulinum neurotoxin

49 The scope of Ipsen and Galderma alliance to keep expanding 2014 achievements and beyond Agreement duration extended to 2036 New territories (o/w US) taken over by Galderma Ipsen acquisition of Galderma s rights to liquid toxin in aesthetics and therapeutics Extension of geographical scope (1) Launch of the first liquid toxin A for aesthetic use with Dysport Solution (ex US) Development and launch of liquid toxin purchased from Galderma in aesthetics (potentially in the US) 49 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) Argentina, Australia and Mexico already signed

50 Areas to reinforce and new targets OWN THE DISEASE CONCEPT Areas to reinforce Prostate cancer Bladder cancer Adult endocrinology New potential targets GI Oncology Orphan Oncology 50 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: NET:Neuroendocrine tumors, GI:Gastrointestinal

51 Ipsen to leverage infrastructure and expertise in urology-oncology through late-stage deals Portfolio 20% market share in Europe Marketed in 7 countries, acknowledged by scientific guidelines and community Commercial presence 150 sales reps targeting 6,000 urologists and 5,000 oncologists in Europe Expertise developed by Somatuline sales force in the US Medical and clinical expertise 10TasQ10 experience: international multicentric 1,200 patient study High credibility in the scientific community manifested in congresses Peptide platform Four on-going projects with potential outcomes in prostate and bladder cancers Candidate validation expected from 2018 Strong expertise acquired through Decapeptyl, Hexvix and tasquinimod 51 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: BD: business development

52 Decapeptyl to benefit from life-cycle management and emerging market growth 1 2 Backbone therapy for prostate cancer care 3-month subcutaneous route of administration Data generated in backbone therapy Use in combination (with new hormones, chemo, etc.) Explicit recommendation in major guidelines (ASCO 2014, EAU 2015) Enlarged patient pool (e.g. patients with anti-coagulant) Strengthened efficacy evidence with 93% of castrated patients at 183 days 3 China growth reservoir Double-digit growth of gynecology markets throughout 2020 Development of prostate cancer indication Extended coverage with penetration of tier 2/3 cities 4 Combination in breast cancer Phase III studies in combination with exemestane or tamoxifen (1) Positive regulatory feedback from MHRA Regulatory plan and commercial model under development (1) Ipsen Investor Day 2 July 2015 Study led by IBCSG (the International Breast Cancer Study Group) Pagani O. NEJM,371: , July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: MHRA:Medicines and Healthcare products Regulatory Agency

53 GI and Orphan oncology offer the best rationale for opportunistic expansion Rationale Approach Gastrointestinal Research platform in place Ipsen knowledge of the GI area Leverage peptide platform Opportunistic Business Development to pave the way for internally developed products Orphan Unmet medical needs Business model close to Ipsen s current niche model Accessible markets for a midsize Pharma Incentive schemes for quicker access to market Leverage peptide platform Opportunistic Business Development 53 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: GI: Gastrointestinal

54 Primary Care

55 Ipsen primary care legacy composed of strong brand equity, GI franchise, and emerging market footprint Launch date Sales split by indications (2014) Sales split by geographies (2014) 26% Other 36% Western Europe 312M (1) 4% Drug-related 312M (1) Gastro intestinal 70% Emerging markets 64% 55 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: GI: Gastrointestinal (1) Excluding drug-related sales

56 Primary care decline in France to reach a floor After 10 years of decline France primary care revenues evolution (1) France now accounts for 28% of total primary care France weight in total 2014 sales Sales in M 300 France Other % 28% (2) M 312M % 72% Primary care France remains profitable thanks to significant restructuring Emerging market growth limiting French decline 56 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) Including Adenuric French co-promotion revenues

57 A new strategic vision for Primary Care A vision Leaning on three pillars Be a preferred partner in gastroenterology in current and promising geographies building on well-known brands serving the needs of patients and customers 2. Expand into new geographies 1. Maximize existing business 3. Expand into new GI areas Ipsen to build OTx capabilities to serve new strategy 57 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: GI: Gastrointestinal OTx: Dual channel approach (Rx/OTC)

58 Smecta, a powerful brand value with untapped potential Smecta brand recognition Consumers Interest Score High potential in other GI fields Bloating Benchmark Benchmark Benchmark Constipation Flatulence 93% 94% 82% 75% 80% 79% 60% 65% 98% 92% 85% 70% Nausea / vomiting Abdominal pain Heartburn Diarrhea Abdominal discomfort France Russia China Average benchmark (1) Smecta lowest score Top benchmark (2) Smecta Highest score Intestinal flora imbalance Cramps / Spasms Heavy digestion 58 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) Average Benchmark = Top 50 (2) Top Benchmark = Top 25

59 1 - Maximize existing business through LCM and BD 1 Capture diarrhea market share with consumer segmentation Liquid Form New Taste Smecta Available! on the go (1) Soon! Other segmentation & line extension (i.e. baby form, chronic formulation) 2 Brand stretch in other Gastroenterology fields through API combinations Diarrhea Available! Irritable Bowel Syndrome Abdominal pain Other (1) Ipsen Investor Day 2 July 2015 Smecta 59 strawberry flavor available in China, soon in France 59 Goldman Sachs 35th Annual Global Healthcare Conference June Note: 2014 GI: Gastrointestinal, LCM=Life Cycle Management, BD=Business Development, API=Active Principle

60 2 - Expand into new geographies Ipsen primary care current footprint Targets for geographical expansion EUROPE BRAZIL, CANADA, AUSTRALIA MIDDLE EAST Primary Care OPERATIONS Primary Care PARTNERS AFRICA 60 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

61 3 - Expand into new GI areas, notably in probiotics Objectives Market characteristics Markets Growth Unmet needs OTX Medical Innovation Reinforce Expertise in diarrhea Expertise in constipation ~ 1bn ~ 1bn Irritable bowel syndrome NA Enter Inflammatory bowel diseases ~500m - Health Probiotics OTX ~ 2bn (1) 61 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: Addressable markets limited to Ipsen key countries and targeted territories (1) Overall Health Probiotic Market

62 Ipsen s strong primary care assets validate the move to OTx model Portfolio OTx model Brand power Reimbursed if prescribed Ipsen s assets Strong brand recognition Portfolio originally in Rx Available in self-medication in many countries Innovation Strong innovation to constantly adapt to consumer needs Innovation & LCM (Smecta RTU, Smecta Strawberry) Industrial legacy BD capacity Geographical presence Countries with history of patient co-pay Strong presence in France & emerging markets (China, Russia, Algeria) Absence from Americas and Western Europe Sales force capabilities Mixed model from GPs to Pharmacies Mixed model in France, Russia and evolving towards pharmacies in China 62 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: Rx: prescription, OTx: Dual channel approach (Rx/OTC) RTU: Ready-to-use, LCM: Life cycle management, GP:General Practitioner

63 Key strategy takeaways Specialty care 3 niche therapeutic areas with potential to become leader (NET, spasticity, and Dysport aesthetics through Galderma partnership) 2 historical therapeutic areas to reinforce (urology-oncology and adult endocrinology) Adjacent therapeutic areas to explore (GI and orphan cancers) Primary care Building of GI/OTx franchise on strong existing brands Reinforcement of geographical coverage Continued transformation to improve efficiency 63 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

64 R&D update Claude P. Bertrand Chief Scientific Officer

65 Global Core R&D footprint: 350 employees in four main sites Ipsen BioInnovation (Oxford, UK) R&D/Toxins (Beijing, China) Drug Development Ipsen BioScience (Cambridge, MA) R&D/Peptides Ipsen Innovation (Les Ulis, France) R&D and Campus 187 million (~15% of sales) invested in R&D in Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

66 Key R&D achievements over the period Somatuline NET: CLARINET /ELECT 8 phase III delivered Dysport spasticity: AUL/ALL/PLL Dysport solution: Cervical dystonia Decapeptyl prostate cancer: 3-month subcutaneous injection tasquinimod: prostate cancer 2 phase II delivered Dysport solution (liquid): Glabellar lines Dysport urology: NDO 1 phase I delivered BN 82451: Huntington Disease Consistent R&D execution allowing on-time deliveries 66 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: NET:Neuroendocrine tumors, AUL: Adult Upper Limb, PLL: Pediatric Lower Limb, ALL: Adult Lower Limb, NDO: Neurogenic Detrusor Overactivity

67 R&D fully aligned with Group strategy with two core platforms serving niche therapeutic areas PEPTIDES TOXINS Reach global leadership NET Spasticity Neurotoxin for aesthetics (Galderma) Areas to reinforce Prostate cancer Bladder cancer Adult endocrinology New potential playgrounds GI Oncology Orphan Oncology 67 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

68 Peptides Oncology / Endocrinology

69 A new state-of-the-art facility for peptides research recently inaugurated in Cambridge, USA World-class office and laboratory space within #1 Biopharma cluster in the US Good position to fully exploit the Cambridge ecosystem Project completed on time (July 2014) and on budget At the heart of the global scientific and technological hub Ipsen Bioscience well positioned to develop entrepreneurial spirit of a start-up company 69 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

70 A rich oncology/endocrinology pipeline Oncology Research Preclinical Phase I/IIa Phase IIb/III Submission Intracellular oncology target SOMTher (OPS201) Somatuline PRF GEP NET SOMScan (OPS202) Somatuline Autogel GEP-NET US Transmembrane oncology target Telotristat etiprate Somatuline Autogel GEP-NET Europe New PRRT Somatuline GEP NET Japan Decapeptyl 3M (Subcutaneous injection) Adult endocrinology Cushing target Dopastatin 2 nd Generation NFPA target TSI Somatuline PRF Acromegaly New products Signed business development Life cycle management Ipsen Investor Day 2 July 2015 Note: PRF:Prolonged Release Formulation, GEP NET:Gastroenteropancreatic neuroendocrine tumors Goldman Sachs 35th Annual Global Healthcare PRRT: Conference Peptide June Receptor 2014 Radionuclide Therapy, NFPA: Non-Functioning Pituitary Adenoma, TSI: Targeted Secretion Inhibitors

71 SOMscan and SOMther, PRRT with high NET potential A theranostic approach Description Peptide-Guided Radioisotope for PRRT Tumor Cell Radioisotope Peptide Analog Chelator Peptide Receptor on Surface of Tumor Cell Scientific rationale Improved receptor binding through antagonist properties Step 1 Step 2 Step 3 Medical rationale Targets: pancreatic, ileal and bronchial NETs Combination potential: kinase inhibitors, chemotherapy Expansion potential using different GPCR ligands SOMscan to enter Phase III and SOMther to enter Phase I in 2016 Note: NET: Neuroendocrine tumors, PRRT: Peptide Receptor Radionuclide Therapy, GPCR: G protein 71 Ipsen Investor Day 2 July 2015 coupled receptors 71 Goldman Sachs 35th Annual Global Healthcare Conference June 2014

72 Dopastatin 2 nd generation Description Enhanced suppression of growth hormone Combination of Somatostatin and Dopamin analogs Scientific rationale Improved potency and efficacy in growth hormone suppression vs, Dopastatin 1 st generation Medical rationale Prime target: acromegaly Additional applications: Cushing s Disease, aggressive Adenomas, NETs, non-functioning Pituitary Adenoma 72 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

73 Toxins Movement disorders

74 Syntaxin acquisition has significantly reinforced Ipsen s R&D toxin platform From natural BoNT expertise to full recombinant potential Pharmacological Pre-clinical / Clinical Scale-up Manufacturing Development Potential to combine toxins and peptides Toxin engineering Recombinant technology Targeted Secretion Inhibitors Established network of BoNT experts Intellectual property Ipsen Syntaxin (1) Ipsen now at the forefront of botulinum technology 74 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) Now Ipsen BioInnovation

75 Ipsen BioInnovation, state-of-the-art R&D toxin facility in Abingdon, UK Full and effective integration of Syntaxin Ltd, acquired in 2013 Fully equipped platform for design, manufacturing, and testing of novel toxin-derived proteins All aspects covered from early research to first-in-man studies Syntaxin Ltd renamed Ipsen Bioinnovation Ltd in March Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

76 Ipsen s new-generation toxin programs Targeted Secretion Inhibitors Modified toxins Recombinant technology BoNTs natural diversity First compound to enter clinical phase in Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: BoNTs: Botulinum neurotoxins

77 Recombinant expression of botulinum toxins Gene manipulation Manufacturing DNA encoding: difficult and complex purification and gene manipulation of BoNT from clostridial cultures BoNT manufactured using standard E.coli expression systems to generate recombinant BoNT (rbont) Modified protein isolated, similar to other therapeutic proteins Recombinant expression enables specific modifications to be incorporated into neurotoxin Engineered proteins then created through modified neurotoxins 77 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: BoNT: Botulinum neurotoxin

78 Recombinant technology opens up new therapeutic opportunities Recombinant technology Enhanced characteristics Potency, spread, duration, onset of action, immunogenicity, etc. Manipulation & exploitation Extended indications Formulation, application, delivery devices, alternative payloads, etc. Improved manufacturing Activation, solubility, expression, etc. Modified rbonts used to design variants across all subtypes of natural BoNTs New candidates can potentially be used in all therapeutic areas 78 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: BoNT: Botulinum neurotoxin

79 A rich and balanced neurology/toxin pipeline Therapeutics Research Preclinical Phase I/IIa Phase IIb/III Submission Modified short acting rbont Short acting toxin rbont BN82451B Movements disorders Dysport NDO Dysport AUL spasticity Modified long acting rbont Long acting toxin rbont VSN16R (Canbex) Multiple sclerosis spasticity Dysport ALL spasticity Dysport Solution (liquid) cervical dystonia LRKK2 inhibitors in Parkinson disease Dysport PLL spasticity Dysport PUL spasticity Aesthetics Galderma s liquid toxin Dysport Solution (liquid) Glabellar lines Dysport Glabellar lines China New products Signed business development Life cycle management Ipsen Investor Day 2 July 2015 Note: AUL:Adult Upper Limb, ALL:Adult Lower Limb, PLL:Pediatric Lower Limb, PUL:Pediatric Upper Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Limb, NDO:Neurogenic Detrusor Overactivity, rbont: recombinant Botulinum neurotoxin

80 New generation short and long acting toxins Toxin Development phase rbont/e Short acting recombinant toxin E Expected move to clinical phase early 2016 mrbont/a Long acting recombinant modified toxin A Expected move to clinical phase in Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: mrbont: modified recombinant neurotoxin

81 Targeted Secretion Inhibitors (TSI) Neuromuscular Pain Binding to specific cell. Interchangeable between cell types. Endocrine Proliferative Disease Enzyme Multiple serotypes A-G Transport New Targets Ability to change the binding site to broaden therapeutic potential 81 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

82 An R&D model under transformation

83 Initiatives to improve R&D productivity Open innovation Flexibility Delivery Focus and POC (2) centric Biotechs Academic clinical centers of excellence Strategic sourcing In-house resource focused on core activities Efficient use of CROs for non-core activities Lean organization One NME (1) every 4 years Value-added products: precision medicine and targeted therapies 2 technology platforms 3 therapeutic areas Strengthening early drug development/ POC (2) know-how and capabilities 83 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) NME: New Molecular Entity (2) POC: Proof of Concept

84 The Campus concept in les ULIS begins to emerge Paris Saclay: a worldwide cluster at the heart of open innovation Open innovation in an open campus >300 laboratories 10% of total R&D headcount in France 60,000 students 5,700 doctors 2.2bn invested by million square meters available 84 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

85 In-house R&D complemented with an active partnership policy Early-stage and academic Late-stage development & marketing Open culture at the heart of Ipsen s R&D model 85 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

86 Early drug development based on integrated expertise Clinical pharmacology & Early development team Non clinical & Clinical pd & safety Pharmacokinetics & Drug metabolism Transcriptomics Biomarkers Computerized analysis Early Drug Development Early clinical formulation Modelling & Simulation (Biometry leader) Clinical operations 86 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

87 Key R&D takeaways: a model under transformation fully aligned with Group strategy Ipsen R&D TOXINS PEPTIDES Business development Movement disorder Aesthetics (Galderma) Oncology / Endocrinology GI / Orphan oncology Phase III life cycle management delivering for short-term growth A replenished research portfolio to enter clinical phase in the next 5 years A clinical pipeline to be reinforced with BD and partnerships Ongoing transformation to improve flexibility and accelerate deliveries 87 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: BD: business development; GI: Gastrointestinal

88 Financials Aymeric Le Chatelier Chief Financial Officer

89 First quarter 2015 sales driven by strong specialty care Sales Q (in million euros) % excluding foreign exchange impact Somatuline +25.0% 89 Decapeptyl +9.2% 83 Dysport Nutropin (0.8%) % 69 Specialty care 266m +14.6% Increlex Hexvix % (3.3%) Group sales 350m +11.7% Smecta Tanakan (27.4%) % 36 French primary care: (5.6%) Primary care 84m +3.3% Forlax +7.5% 9 International primary care : +7.1% 89 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

90 2015 guidance revised upwards to reflect strong specialty care and tasquinimod savings Initial 2015 guidance Revised 2015 guidance (1) Specialty care sales growth Between +8% and +10% Between +10% and +12% Primary care sales growth Between -3% and 0% Between -3% and 0% Core operating margin Between 19% and 20% Between 21% and 22% Sales objectives are set at constant currency 90 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) On 29 April 2015

91 2020 organic sales outlook [6% - 8%] Group sales [ 1.8bn - 2.0bn] Group sales ~ 1.3b Specialty care (1) Specialty care [7%; 9%] Primary care [2%; 4%] Primary care CAGR (2) Potential Business Development to complement 1.8bn to 2.0bn organic sales target 91 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) Including new pipeline products telotristat etiprate, SOMscan (2) CAGR: Compound Annual Growth Rate at constant currency

92 2020 specialty care organic sales growth outlook Specialty care [ 1.4bn ; 1.6bn] Other SC Specialty care ~ 950m Other SC Low single digit High single digit Low double digit CAGR (1) Somatuline and Dysport, the Group s main growth drivers throughout Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) Compound Annual Growth Rate at constant currency Other SC: Including Increlex, Hexvix, NutropinAq, and pipeline compounds

93 2020 profitability outlook and drivers 2020 Sales Key drivers Strong organic growth Core Operating Margin > 26% COGS ratio S&M ratio R&D ratio G&A ratio Product mix and manufacturing efficiencies Limited additional investment to support growth after NET launch Continuous investment to develop products and NMEs Sales growth and cost initiatives Margin expansion to be mainly driven by sales growth and US profitability 93 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: COGS: Cost of Goods Sold, S&M: Sales and Marketing, R&D: Research and Development, G&A: General and Administrative NMEs: New Molecular Entities

94 Illustrations of SMM and G&A optimization initiatives European Business Units Creation of 3 European business units: Dysport Therapeutics, Hexvix and pediatric endocrinology to: Support growth and optimize resource allocation in Europe Focus on key European accounts Geographic clustering Creation of clusters in Spain/Portugal, UK/Ireland, Nordics/Baltics and Eastern European countries: Resource pooling (medical, regulatory, marketing and sales, finance) Support functions Streamlining, back-office consolidation, shared services, outsourcing across all support functions: Finance, Human resources, IT 94 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: S&M: Sales and Marketing, G&A: General and Administrative

95 2020 profitability drivers per business unit Specialty care Primary care Sales High-single organic growth Low-single organic growth COGS > 80% gross margin (1) > 60% gross margin (1) S&M NET and spasticity launches Limited incremental investment R&D Continued investment Very limited investment Specialty care to drive 2020 Group margin improvement 95 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: S&M: Sales and Marketing, COGS: Cost of Goods Sold (1) Excluding other revenues

96 Evolution of P&L items below Core Operating Income over Restructuring Limited additional restructuring expected beyond 2015 Tax Positive cash impact from US tax losses Effective tax rate to remain unchanged Discontinued operations Negative impact from tasquinimod discontinuation in 2015 Potential positive impact from OBI1 royalties paid by Baxter Consolidated net profit growth to be mainly driven by core operating income 96 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

97 Ipsen to derive potentially significant value from non core outlicensed assets Lead compound abaloparatide for treatment of osteoporosis successfully completed Ph3 Market capitalization > $2bn Ipsen to receive regulatory milestones and royalties on future global sales (ex Japan) FDA approval of OBI-1 in acquired hemophilia A Acquired OBI-1 (factor 8 from porcine origin) from Inspiration Inc bankruptcy Ipsen and other sellers to receive royalties based on sales level (started end of 2014) 2 lead programs: Relamorelin (Ph2 completed for diabetic gastroparesis) and MC4 (Ph2 ongoing for obesity) Ipsen owns 6.11% of equity shares on a fully diluted basis Ipsen to receive development and regulatory milestones and royalties on both programs 97 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014

98 Evolution of cash flow over Operating cash flow Mainly driven by accelerated organic growth Capex Additional capacities required to support Somatuline and Dysport growth Dividend Consistent dividend policy in line with core net income growth Share buyback External growth Ongoing program for 500,000 shares Further repurchases on an opportunistic basis Continued effort to find attractive business development opportunities Solid cash generation to finance operations, external growth and return to shareholders 98 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: BD:Business development

99 Strong balance sheet and financial discipline to support business development ambition 600m envelope for acquisitions Financing Strong operating cash-flow generation 500m revolving credit facility and 180m (1) in cash at disposal Unleveraged balance sheet/access to attractive financing Investment criteria DCF value-based assessment Risk-return balance Expected synergies Specific assessment for early-stage projects Strategic fit and financial discipline drive decision-making 99 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) As of 31 December 2014 DCF:discounted cash-flow

100 Strong base business growth and financial discipline to increase cash generation Strong sales growth Business development Operating leverage Cash generation Significant margin improvement Financial discipline allowing for external acquisitions and increased shareholder return 100 Ipsen Investor Day 2 July Goldman Sachs 35th Annual Global Healthcare Conference June 2014