Ipsen Sa · EURONEXT:IPN
Ipsen Sa — Investor Day (July 2015)
103 slides from Ipsen Sa's investor day presentation, Jul 2, 2015
Slide 1: Ipsen Investor Day
Ipsen Investor Day 2 July 2015
Slide 2: Disclaimer
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 an
Slide 3: Safe Harbor
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, an
Slide 4: Agenda
Agenda Marc de Garidel Chairman and Chief Executive Officer
Slide 5: Agenda for the day
Agenda for the day 14:00-14:25 Introduction Marc de Garidel, CEO 14:25-15:45 Group strategy Christel Bories, Deputy CEO 15:45-16:00 Q&A session 16:00-16:10 Coffee break 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 Garid
Slide 6: Introduction
Introduction Marc de Garidel Chairman and Chief Executive Officer
Slide 7: The 2011 strategy initiated a period of significant progress
The 2011 strategy initiated a period of significant progress… Increase Invest Leverage Focus to Grow Footprint Endocrinology/NET Peptides United States Neurology Toxins Emerging Markets Urology-Oncology Business development Europe 2020 ambition More than double sales(1) More than triple EBIT(2) (1)
Slide 8: Group became a global specialty care company
… which led the Group to become a global specialty care company Sales by segment Sales by geography Emerging Specialty 32% ~65% markets care Primary 2010 Europe 50% ~35% care G5 5% 13% US RoW Primary care Europe Emerging ~25% G5 39% 39% markets Q1 2015 ~75% Specialty 9% care 14% RoW US 8 Ipsen Inves
Slide 9: Specialty care, the growth engine over 2010-2014
Specialty care, the growth engine over 2010-2014 Specialty care Growth drivers +8% ~€950m Other SC Specialty care (SC) +3% ~€700m China Other SC +4% Aesthetics +9% NET +14% 2010 CAGR(1) 2014 9 Ipsen Investor Day – 2 July 2015 (1) Compound Annual Growth Rate at constant currency 9 Goldman Sachs 35th
Slide 10: Key achievements 2010 - 2015
Key achievements 2010 - 2015 8 Phase III programs delivered Strengthened Consolidation in toxin research (Syntaxin/Harvard partnership) R&D Boston peptide platform revamped FDA approval of Somatuline® as first line treatment in NET Reinforced BD Galderma expanded partnership capacity Tel
Slide 11: Turnaround of the US platform, with high potential for growth
Turnaround of the US platform, with high potential for growth Sales growth(1) ~$1 billion addressable market Acromegaly 55.3% ~$100m 31.2% NET ~$600m ~$300m Spasticity 11.5% 2013 2014 Q1 2015 Key accomplishments Somatuline® unique first-line label in Reinforcement of Dysport® organization NET grante
Slide 12: Business development strategy starting to pay off
Business development strategy starting to pay off with 4 deals signed in the last 12 months OctreoPharm (NET) Canbex (Spasticity) Company acquisition Call option for company May 2015 Telotristat (NET) acquisition(1) €50m total milestones In-licensing of global rights (ex US/Japan) February 2015 Octo
Slide 13: 2011-2015 achievements reflected in share price performance
2011-2015 achievements reflected in share price performance Share price evolution (Jan. 2011-June 2015) IPSEN 55 2011-2012: Reorganization period 2013-2015: Growth period +121% 50 Stoxx 45 Pharma(1) 40 +108% Inspiration exit decision 35 SBF 120 30 +39% 25 20 15 13 Ipsen Investor Day – 2 July 2015 (1
Slide 14: 2015-2020: A refocused strategy within specialty and primary care
2015-2020: A refocused strategy within specialty and primary care Global leadership in targeted diseases Focus on GI/OTx 14 Ipsen Investor Day – 2 July 2015 Note: GI:Gastrointestinal, Otx:Dual channel approach (Rx/OTC) 14 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014
Slide 15: Specialty care strategic focus
Specialty care strategic focus Reach global leadership in niche therapeutic areas… Aesthetics NET Spasticity (through Galderma) …strengthen positions in historical therapeutic areas… …and explore new targets Adult GI/Orphan Uro-oncology Endocrinology oncology 15 Ipsen Investor Day – 2 July 2015 Note
Slide 16: Primary care: focus on GI/OTx
Primary care: focus on GI/OTx Maximize existing Expand into new Expand into new business with GI areas geographies OTx shift 16 Ipsen Investor Day – 2 July 2015 Note: GI: Gastrointestinal, OTx: Dual channel approach (Rx/OTC) 16 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014
Slide 17: Strong Business development focus to complement organic growth
Strong Business development focus to complement organic growth Therapeutic areas Geographies Late stage NET deals Spasticity US Uro-oncology Europe GI/Orphan oncology Emerging markets Early stage deals Primary care 17 Ipsen Investor Day – 2 July 2015 Note: GI: Gastrointestinal 17 Gol
Slide 18: 2020 outlook showing strong sales growth and profitability momentum
2020 outlook showing strong sales growth and profitability momentum Group organic sales Core operating income margin(1) >+560bps [+6% to +8%] CAGR +130bps >26% [€1.8bn - €2bn] ~+4% CAGR 20.4% 18.9% €1.3bn €1.1bn 2010 2014 2020 E 2010 2014 2020 E Ipsen to outperform industry growth 18 Ipsen Investor
Slide 19: Group strategy
Group strategy Christel Bories Deputy Chief Executive Officer
Slide 20: A refocused strategy within specialty and primary care
A refocused strategy within specialty and primary care Global leadership in Focus on GI/OTx targeted diseases 20 Ipsen Investor Day – 2 July 2015 Note: GI:Gastrointestinal, Otx:Dual channel approach (Rx/OTC) 20 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014
Slide 21: Own the disease business model to achieve leadership
« Own the disease » business model to achieve leadership « Own the disease » business model Key features of category leaders 1 • Focus on few disease areas Customized solutions combining scientific with high R&D expertise and marketing perspectives and strong innovation 2 Strong relationships with k
Slide 22: Ongoing transformation to adapt company profile
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 outper
Slide 23: Deep transformation process involving all parts of the company
Deep transformation process involving all parts of the company Specialty Care Primary care operations Commercial GI & OTX focus optimization Franchises Open Focus Flexibility Delivery and POC Focused portfolio Ipsen’s innovation centric management & launch transformation Open innovation excellence R
Slide 24: NeWayS: commercial initiatives to optimize specialty care growth
NeWayS : 10 commercial initiatives to optimize and sustain growth in specialty care European Oncology Business Boost Units Aesthetics Geographic Centre of Clustering Excellence Therapeutic area Geographic optimization optimization Medical Purchasing Optimization NeWayS excellence Additional sales Ne
Slide 25: Specialty care
Specialty care
Slide 26: Reach global leadership in targeted diseases
Reach global leadership in targeted diseases, reinforce position in historical areas, and explore new targets NET Global leadership Spasticity Neurotoxin for aesthetics (Galderma) Prostate cancer OWN THE DISEASE Areas to reinforce Bladder cancer Adult endocrinology GI Oncology New potential targets
Slide 27: Focus on Neuroendocrine tumors (NETs)
Focus on Neuroendocrine tumors (NETs) Global leadership NET OWN THE DISEASE 27 Ipsen Investor Day – 2 July 2015 Note: NET:Neuroendocrine tumors, GI:Gastrointestinal 27 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014
Slide 28: Neuroendocrine tumors in a nutshell
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 2 Lung US and Europe GEP NET prevalence: Credits: 1BSIP, Estiot;
Slide 29: Ipsen acquisitions to address the whole NET treatment paradigm
Beyond Somatuline®, Ipsen made two acquisitions to address the whole NET treatment paradigm Diagnosis Imaging SOMscan® Monitoring 1st line Somatuline® Symptom (SSA) control (ex-US) 2nd line Telotristat (not SSA controlled) (carcinoid syndrome) 1st line Somatuline® (SSA) Tumor control 2nd line SOMthe
Slide 30: Somatuline, the first SSA approved for tumor control of GEP-NET
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 2015 Note: GEP NET:Gastroenteropancreatic neuroendocrine tumor, SSA: Soma
Slide 31: Somatuline sales and market share accelerating in US and Europe
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 (%) 8 16 37 7 40 6 32 13 35 5 27 4 22 30 10 3 17 25 2 12 7 1 7 20 Q1 2013 Q3 20
Slide 32: Xermelo (telotristat etiprate) for NET symptom control
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 Q3 2015 Expected launch in 2017 in Europe Estimated
Slide 33: SOMscan: a new generation imaging agent for NET
SOMscan®: a new generation imaging agent for NET Octreoscan® SOMscan® 68Gallium-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 2015 Note:
Slide 34: SOMther: potentially best in class PRRT
SOMther®: potentially best in class PRRT with a wider therapeutic window for NET patients progressing under SSA Lutetium combined with SSTR2 antagonists for 2nd line treatment of NET patients progressing under SSA To be manufactured and distributed inclusive of peptide and radionuclide Current
Slide 35: NET treatment paradigm still offers room for expansion
NET treatment paradigm still offers room for expansion OTHER DIAGNOSIS 1 Somatuline® life cycle Imaging management 2 Symptom SERVICES Control Business TO OTHERS development PATIENTS Tumor control 3 Patient-targeted approaches and COMORBIDITIES services PALLIATIVE CARE Current presence Room for expan
Slide 36: Focus on spasticity
Focus on spasticity Global leadership Spasticity OWN THE DISEASE CONCEPT 36 Ipsen Investor Day – 2 July 2015 Note: NET:Neuroendocrine tumors, GI:Gastrointestinal 36 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014
Slide 37: Spasticity to remain the largest segment of the toxin market
Spasticity to remain the largest segment of the fast-growing therapeutic toxin market Toxin therapeutic market by indication 2014 2022 Other Other Blepharospasm Blepharospasm 7%2% Cervical 4%2% dystonia 12% Cervical 21% 41% Spasticity 43% Spasticity dystonia Chronic ~€1.3 bn 15% ~€2.8 bn migraine 16
Slide 38: Dysport to become a global differentiated toxin
Dysport® to become a global differentiated toxin with full spasticity reach TODAY TOMORROW Restricted Improved spasticity label label No spasticity indication New indications Incomplete Complete spasticity spasticity label coverage Undifferentiated Differentiated toxin toxin (liquid, new toxins) Inv
Slide 39: Ipsen, a leading player in spasticity, catching up in the US
Ipsen, a leading player in spasticity, catching up in the US 2014 Dysport® market share in spasticity (ex US) Other Dysport® therapeutics, leader in several Xeomin® 2% countries: 14% 34% Dysport® – Russia – Brazil 50% – UK Botox® Ipsen boasts high market shares in its spasticity markets Ipsen curren
Slide 40: Dysport, a great potential of differentiation in spasticity
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) R
Slide 41: Ipsen on track to succeed with US spasticity launch
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 Potential full adult spasticity coverage Filing
Slide 42: Dysport Solution, potentially the first liquid toxin
Dysport® Solution, potentially the first liquid toxin on the market (ex-US) Enhanced safety and cost Ready-to-use (no reconstitution) Dysport® Solution (liquid) Ability to reach more Full product range patients Dysport® Solution to be filed in Cervical Dystonia in Europe and Brazil in H1 2016 42 Ips
Slide 43: LCM and Canbex acquisition position Ipsen in spasticity treatment
Through LCM and Canbex acquisition, Ipsen well-positioned on the spasticity treatment paradigm Other 1st line pathologies in (oral muscle spastic relaxants) patients Dysport ® 2nd line Dysport® Dysport® (NDO, (toxin) Solution Sialorrhea) Canbex Other (multiple treatments sclerosis) In R&D pipeline M
Slide 44: Canbex's deal option, a promising opportunity
Canbex’s deal option, a promising opportunity New Market Existing Market Spasticity Diagnosed VSN16R use 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 t
Slide 45: Spasticity treatment paradigm still offers room for expansion
Spasticity treatment paradigm still offers room for expansion DIAGNOSIS 1st line (oral muscle relaxants ) Other pathologies in spastic 2nd line patients OTHERS (toxin) (NDO, Sialorrhea) Other treatments FOLLOW-UP Current presence Room for expansion 45 Ipsen Investor Day – 2 July 2015 Note: BD: Busin
Slide 46: Spasticity strategy key takeaways
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 indi
Slide 47: Neurotoxin for aesthetics through Galderma alliance
Neurotoxin for aesthetics through Galderma alliance Neurotoxin for Global leadership aesthetics (Galderma) OWN THE DISEASE CONCEPT 47 Ipsen Investor Day – 2 July 2015 Note: NET:Neuroendocrine tumors, GI:Gastrointestinal 47 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014
Slide 48: Aesthetics, a fast-growing market generating half of Dysport sales
Aesthetics, a fast-growing market generating half of Dysport® sales Dysport® 2014 revenues(1) split (%) Aesthetics BonT market(2) (€ billion) +9% 1.8 1.6 1.7 1.3 1.4 1.1 1.2 Aesthetics 50% 50% Therapeutics 2014 2015 2016 2017 2018 2019 2020 Ipsen markets Dysport® in Aesthetics: Strong volume growth
Slide 49: The scope of Ipsen and Galderma alliance to keep expanding
The scope of Ipsen and Galderma alliance to keep expanding 2014 achievements 2015-2016 2017 and beyond Agreement duration Extension of Launch of the first liquid extended to 2036 geographical scope(1) toxin A for aesthetic use with Dysport® Solution New territories (o/w US) (ex US) taken ove
Slide 50: Areas to reinforce and new targets
Areas to reinforce and new targets OWN THE Prostate cancer DISEASE Areas to reinforce Bladder cancer CONCEPT Adult endocrinology GI Oncology New potential targets Orphan Oncology 50 Ipsen Investor Day – 2 July 2015 Note: NET:Neuroendocrine tumors, GI:Gastrointestinal 50 Goldman Sachs 35th Annual Glo
Slide 51: Leveraging expertise in urology-oncology through late-stage deals
Ipsen to leverage infrastructure and expertise in urology-oncology through late-stage deals 20% market share in Europe Portfolio Marketed in 7 countries, acknowledged by scientific guidelines and community Commercial 150 sales reps targeting 6,000 urologists and 5,000 oncologists in Europe pre
Slide 52: Decapeptyl to benefit from life-cycle management and emerging markets
Decapeptyl® to benefit from life-cycle management and emerging market growth 1 Data generated in backbone therapy Backbone therapy Use in combination (with new hormones, chemo, etc.) for prostate cancer care Explicit recommendation in major guidelines (ASCO 2014, EAU 2015) 2 Enlarged patient
Slide 53: GI and Orphan oncology offer the best rationale for expansion
GI and Orphan oncology offer the best rationale for opportunistic expansion Rationale Approach Leverage peptide platform Research platform in place Opportunistic Business Gastrointestinal Ipsen knowledge of the GI Development to pave the area way for internally developed products Unmet med
Slide 54: Primary Care
Primary Care
Slide 55: Ipsen primary care legacy: brands, GI franchise, emerging markets
Ipsen primary care legacy composed of strong brand equity, GI franchise, and emerging market footprint 1975 1988 1994 Launch date Sales split by indications (2014) Sales split by geographies (2014) Western Other 26% 36% Europe €312M(1) €312M(1) 4% Drug-related 70% 64% Gastro Emerging intestinal mark
Slide 56: Primary care decline in France to reach a floor
Primary care decline in France to reach a floor … France now accounts for 28% of After 10 years of decline … total primary care France primary care revenues evolution(1) France weight in total 2014 sales Sales in M€ 300 France Other 250 200 28%(2) 28% 150 €368M €312M 100 72% 72% 50 0 2004 2014 2
Slide 57: A new strategic vision for Primary Care
A new strategic vision for Primary Care A vision… … Leaning on three pillars Be a preferred partner in 2. Expand into new geographies gastroenterology… … in current and promising 1. geographies… Maximize existing … building on well-known business brands… … serving the needs of patients and customers
Slide 58: Smecta, a powerful brand value with untapped potential
Smecta®, a powerful brand value with untapped potential Smecta® brand recognition High potential in other GI fields Consumers Interest Score Bloating Benchmark Benchmark Benchmark Constipation Flatulence 94% 98% 93% 92% 82% 80% 79% 85% 75% Nausea / Abdominal 70% vomiting pain 65% 60% Heartburn Abdom
Slide 59: Maximize existing business through LCM and BD
1 - Maximize existing business through LCM and BD Capture diarrhea market share with consumer segmentation 1 Other segmentation Liquid Form – & line extension New Taste Available!(1) Smecta® on the go (i.e. baby form, Soon ! chronic formulation) Brand stretch in other Gastroenterology fields through
Slide 60: Expand into new geographies
2 - Expand into new geographies Ipsen primary care current footprint Targets for geographical expansion EUROPE BRAZIL, CANADA, AUSTRALIA MIDDLE EAST Primary Care Primary Care OPERATIONS PARTNERS AFRICA 60 Ipsen Investor Day – 2 July 2015 60 Goldman Sachs 35th Annual Global Healthcare Conference – Ju
Slide 61: Expand into new GI areas, notably in probiotics
3 - Expand into new GI areas, notably in probiotics Objectives Market characteristics Unmet Medical Markets Growth OTX needs Innovation Expertise in diarrhea ~€1bn - - Reinforce Expertise in constipation ~€1bn - - Irritable bowel syndrome NA Enter Inflammatory bowel diseases ~500m€ -
Slide 62: Strong primary care assets validate the move to OTx model
Ipsen’s strong primary care assets validate the move to OTx model OTx model Ipsen’s assets Strong brand recognition Brand power Portfolio Portfolio originally in Rx Reimbursed if prescribed Available in self-medication in many countries Strong innovation to Innovation & LCM (Smecta® RTU, Sme
Slide 63: Key strategy takeaways
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 (
Slide 64: R&D update
R&D update Claude P. Bertrand Chief Scientific Officer
Slide 65: Global Core R&D footprint in four main sites
Global Core R&D footprint: 350 employees in four main sites Ipsen BioInnovation (Beijing, China) (Oxford, UK) Drug Development R&D/Toxins Ipsen BioScience Ipsen Innovation (Cambridge, MA) (Les Ulis, France) R&D/Peptides R&D and Campus €187 million (~15% of sales) invested in R&D in 2014 65 Ipsen Inv
Slide 66: Key R&D achievements over the 2010-2015 period
Key R&D achievements over the 2010-2015 period Somatuline® NET: CLARINET®/ELECT® Dysport® spasticity: AUL/ALL/PLL 8 phase III Dysport® solution: Cervical dystonia delivered Decapeptyl® prostate cancer: 3-month subcutaneous injection tasquinimod: prostate cancer Dysport® solution (liquid): Glabellar
Slide 67: R&D aligned with Group strategy with two core platforms
R&D fully aligned with Group strategy with two core platforms serving niche therapeutic areas PEPTIDES TOXINS NET Reach global leadership Spasticity Neurotoxin for aesthetics (Galderma) Prostate cancer Areas to reinforce Bladder cancer Adult endocrinology New potential GI Oncology play
Slide 68: Peptides Oncology / Endocrinology
Peptides Oncology / Endocrinology
Slide 69: New peptides research facility inaugurated in Cambridge, USA
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 gl
Slide 70: A rich oncology/endocrinology pipeline
A rich oncology/endocrinology pipeline Oncology Research Preclinical Phase I/IIa Phase IIb/III Submission Intracellular oncology SOMTher® (OPS201) Somatuline® PRF SOMScan® (OPS202) Somatuline® Autogel® target GEP NET GEP-NET US Transmembrane oncology Telotristat etiprate Somatuline® Autogel® target
Slide 71: SOMscan and SOMther, PRRT with high NET potential
SOMscan® and SOMther®, PRRT with high NET potential A theranostic approach Description Peptide-Guided Peptide Analog Radioisotope for PRRT Radioisotope Peptide Receptor on Chelator Surface of Tumor Cell Tumor Cell Scientific Improved receptor binding Step 1 Step 2 Step 3 rationale through antagonist
Slide 72: Dopastatin 2nd generation
Dopastatin 2nd generation Enhanced suppression of growth hormone Description Combination of Somatostatin and Dopamin analogs Scientific Improved potency and efficacy in growth hormone suppression rationale vs, Dopastatin 1st generation Medical Prime target: acromegaly rationale Additional
Slide 73: Toxins Movement disorders
Toxins Movement disorders
Slide 74: Syntaxin acquisition reinforced Ipsen's R&D toxin platform
Syntaxin acquisition has significantly reinforced Ipsen’s R&D toxin platform From natural BoNT expertise… … to full recombinant potential Pharmaco- Toxin Manufacturing logical engineering Potential to Targeted combine Scale-up Secretion toxins and Inhibitors peptides Pre-clinical / Recombinant Devel
Slide 75: Ipsen BioInnovation, R&D toxin facility in Abingdon, UK
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 Syn
Slide 76: Ipsen's new-generation toxin programs
Ipsen’s new-generation toxin programs Targeted Secretion Inhibitors Modified toxins Recombinant technology BoNTs natural diversity First compound to enter clinical phase in 2016 76 Ipsen Investor Day – 2 July 2015 Note: BoNTs: Botulinum neurotoxins 76 Goldman Sachs 35th Annual Global Healthcare Conf
Slide 77: Recombinant expression of botulinum toxins
Recombinant expression of botulinum toxins Gene Manufacturing manipulation DNA encoding: difficult and BoNT manufactured using Modified protein isolated, complex purification and standard E.coli expression similar to other gene manipulation of BoNT systems to generate therapeutic proteins from clost
Slide 78: Recombinant technology opens up new therapeutic opportunities
Recombinant technology opens up new therapeutic opportunities Potency, spread, duration, onset of Enhanced characteristics action, immunogenicity, etc. Recombinant technology Formulation, application, delivery Extended indications devices, alternative payloads, etc. Manipulation & exploitation Impro
Slide 79: A rich and balanced neurology/toxin pipeline
A rich and balanced neurology/toxin pipeline Therapeutics Research Preclinical Phase I/IIa Phase IIb/III Submission Modified short acting Short acting toxin BN82451B Dysport® NDO Dysport® AUL spasticity rBoNT rBoNT Movements disorders Modified long acting Long acting toxin VSN16R (Canbex) Dysport® S
Slide 80: New generation short and long acting toxins
New generation short and long acting toxins Toxin Development phase rBoNT/E Expected move to clinical phase early Short acting recombinant 2016 toxin E mrBoNT/A Expected move to clinical phase in Long acting recombinant modified 2017 toxin A 80 Ipsen Investor Day – 2 July 2015 Note: mrBoNT: modified
Slide 81: Targeted Secretion Inhibitors (TSI)
Targeted Secretion Inhibitors (TSI) Neuromuscular Binding to specific cell. Interchangeable between cell types. Pain 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
Slide 82: An R&D model under transformation
An R&D model under transformation
Slide 83: Initiatives to improve R&D productivity
Initiatives to improve R&D productivity Focus and Open Flexibility Delivery POC(2) innovation centric 2 technology platforms In-house resource Biotechs One NME(1) every 4 years 3 therapeutic areas focused on core activities Academic clinical centers Value-added products: Strengthenin
Slide 84: The Campus concept in les Ulis begins to emerge
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 2020 1.3 million square meters available 84 Ip
Slide 85: In-house R&D complemented with an active partnership policy
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 2015 85 Goldman Sachs 35th Annual Global Healthcare Conference – June 2014
Slide 86: Early drug development based on integrated expertise
Early drug development based on integrated expertise Clinical pharmacology & Early development team Non clinical & Pharmacokinetics Clinical pd & safety & Drug metabolism Early Drug Transcriptomics Development Biomarkers Early clinical Computerized formulation analysis Modelling & Simulation Clinica
Slide 87: Key R&D takeaways
Key R&D takeaways: a model under transformation fully aligned with Group strategy Ipsen R&D TOXINS PEPTIDES Business development Movement disorder Oncology / Endocrinology Aesthetics (Galderma) GI / Orphan oncology Phase III life cycle management delivering for short-term growth A replenished resear
Slide 88: Financials
Financials Aymeric Le Chatelier Chief Financial Officer
Slide 89: First quarter 2015 sales driven by strong specialty care
First quarter 2015 sales driven by strong specialty care Sales – Q1 2015 (in million euros) – % excluding foreign exchange impact ® Somatuline +25.0% 89 ® Decapeptyl +9.2% 83 ® Dysport +10.5% 69 Specialty care ® €266m Nutropin (0.8%) 16 +14.6% ® Increlex 5 +126.8% Group sales ® €350m (3.3%) Hexvix 4
Slide 90: 2015 guidance revised upwards
2015 guidance revised upwards to reflect strong specialty care and tasquinimod savings Initial Revised 2015 guidance 2015 guidance(1) Between Between Specialty care sales growth +8% and +10% +10% and +12% Between Between Primary care sales growth -3% and 0% -3% and 0% Between Between Core operating
Slide 91: 2020 organic sales outlook
2020 organic sales outlook Group sales [€1.8bn - €2.0bn] [6% - 8%] Group sales ~€1.3b Specialty care(1) Specialty care [7%; 9%] Primary care [2%; 4%] Primary care 2014 CAGR(2) 2020 Potential Business Development to complement €1.8bn to €2.0bn organic sales target (1) Including new pipeline products
Slide 92: 2020 specialty care organic sales growth outlook
2020 specialty care organic sales growth outlook Specialty care [€1.4bn ; €1.6bn] Other SC Specialty care ~€950m Low single Other SC digit High single digit Low double digit CAGR(1) 2014 2020 Somatuline® and Dysport ®, the Group’s main growth drivers throughout 2020 (1) Compound Annual Growth Rate a
Slide 93: 2020 profitability outlook and drivers
2020 profitability outlook and drivers Key drivers 2020 Sales Strong organic growth COGS Product mix and Core ratio manufacturing efficiencies Operating S&M Limited additional investment to ratio support growth after NET launch Margin R&D Continuous investment to ratio develop products and NMEs > 26
Slide 94: Illustrations of SMM and G&A optimization initiatives
Illustrations of SMM and G&A optimization initiatives Creation of 3 European business units: Dysport® Therapeutics, European Hexvix® and pediatric endocrinology to: Business Units Support growth and optimize resource allocation in Europe Focus on key European accounts Creation of clusters in Spa
Slide 95: 2020 profitability drivers per business unit
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 Special
Slide 96: Evolution of P&L items below Core Operating Income
Evolution of P&L items below Core Operating Income over 2015-2020 Restructuring Limited additional restructuring expected beyond 2015 Positive cash impact from US tax losses Tax Effective tax rate to remain unchanged Discontinued Negative impact from tasquinimod discontinuation in 2015 opera
Slide 97: Value from non core out-licensed assets
Ipsen to derive potentially significant value from non core out- licensed assets Lead compound FDA approval of OBI-1 in 2 lead programs: abaloparatide for treatment acquired hemophilia A Relamorelin (Ph2 of osteoporosis successfully completed for diabetic completed Ph3 Acquired OBI-1 (factor
Slide 98: Evolution of cash flow over 2015-2020
Evolution of cash flow over 2015-2020 Operating cash flow Mainly driven by accelerated organic growth Additional capacities required to support Somatuline® and Capex Dysport® growth Dividend Consistent dividend policy in line with core net income growth Ongoing program for 500,000 shares Sha
Slide 99: Strong balance sheet to support business development ambition
Strong balance sheet and financial discipline to support business development ambition €600m envelope for acquisitions Strong operating cash-flow generation Financing €500m revolving credit facility and €180m(1) in cash at disposal Unleveraged balance sheet/access to attractive financing D
Slide 100: Business growth and financial discipline to increase cash generation
Strong base business growth and financial discipline to increase cash generation… Strong sales growth Business Operating development leverage Significant margin Cash generation improvement Financial discipline …allowing for external acquisitions and increased shareholder return 100 Ipsen Investor Da
Slide 101: Conclusion
Conclusion Marc de Garidel Chairman and Chief Executive Officer
Slide 102: Key takeaways
Key takeaways 1 Focused Strategy on niche disease areas 2 Business development to leverage portfolio and geographies 3 Organic growth acceleration and significant profitability improvement 4 Ipsen to outperform the pharma industry in the next 5 years Ipsen committed to deliver superior shareholder v
Slide 103: Thank you
Thank you