Ipsen J.P. Morgan European Healthcare Conference Thursday, June 26 th IPSEN pour nom de la société - 07/04/2011 / page 1
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 J.P. Morgan European Healthcare Conference 2014
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 J.P. Morgan European Healthcare Conference 2014
Over the last 10 years, Ipsen has become a specialty pharma company with strong emerging market footprint Sales by segment Sales by geographical area Developed RoW 11% Specialty care 48% 52% Primary care (1) 2004 Emerging (3) 19% 70% G5 (2) Specialty care 71% 29% Primary care (1) 2013 Emerging (3) Developed RoW 40% 14% 5% 41% US G5 (2) 4 J.P. Morgan European Healthcare Conference 2014 (1) Including Drug-related sales (2) France, UK, Germany, Italy, Spain (3) Main emerging markets: China, Russia and Brazil
Ipsen ambitions to become a global leader in targeted debilitating diseases Increase Focus Invest to Grow Leverage Footprint Acceleration of transformation 2020 ambition (1) More than double revenues and more than triple EBIT (2) 5 J.P. Morgan European Healthcare Conference 2014 (1) At constant exchange rate vs. 2010 Sales - (2) vs. 2010 EBIT prior to purchase accounting recordings and non recurring elements
2013 overview
2013, acceleration of transformation and major clinical successes Enhanced R&D delivery and focus Four Phase III programs delivered Major step forward in toxin research and Intellectual Property with Syntaxin acquisition and Harvard partnership Christel Bories appointed Deputy CEO Acceleration of transformation Split of Primary and Specialty Care New focus on efficiency and cost control (Successful restructuring of French PC and US Dysport operations) 7 J.P. Morgan European Healthcare Conference 2014
Primary care Specialty care Specialty care sales growth affected by Decapeptyl performance and Increlex shortage Drug sales FY 2013 in million euros % excluding foreign exchange impact Decapeptyl (1.9%) 298.6 Somatuline Dysport Nutropin +5.7% 56.3 +11.1% +7.0% 246.9 242.2 Specialty care 871.1m +3.0% Increlex 12.7 (53.9%) Hexvix Smecta 14.4 +16.7% +8.1% 121.1 Drug sales 1,191.3m +2.1% Tanakan Forlax Fortrans (13.3%) 67.2 +0.3% 38.7 25.0 +26.1% French primary care: (22.0%) International primary care: +13.6% Primary care 320.2m (0.1%) Increlex resupplied in Europe in 2014 8 J.P. Morgan European Healthcare Conference 2014
2013 sales driven by international primary care and specialty care FY sales in million euros GROUP SALES growth: +0.4% (incl. Drug related sales) At constant currency: +2.2% FX (20.8) International French PC PC Increlex (27.1) 26.8 (14.8) Specialty care (1) 39.8 Primary care Specialty care 1,219.5 1,224.8 FY 2012 FY 2013 Continued strategic focus on growth drivers 9 J.P. Morgan European Healthcare Conference 2014 Note: 2012 figures have been restated to provide comparative information between 2012 and 2013 (1) Specialty care excluding Increlex sales
2013: Key financial achievements Group sales up 2.2% (1) Strong Recurring Adjusted (2) Operating margin of 17% (3) Net profit of 153.1m versus a ( 27.5m) loss in 2012 Robust Recurring Adjusted (2) EPS of 1.85, up 5.1% year-on-year Sound operating cash flow generation Closing cash balance of 125.4m Proposed dividend of 0.80 per share, stable year-on-year 10 J.P. Morgan European Healthcare Conference 2014 Note: 2012 figures have been restated to provide comparative information between 2012 and 2013 (1) Excluding foreign exchange impact (2) Prior to non-recurring elements (3) In percentage of sales
US update
Increasing US presence, a strategic priority Global Pharma Market ( * ) Ipsen 2013 sales Developed RoW 21% 15% G5 (1) Developed RoW 14% 41% G5 (1) Emerging 30% 34% United States Emerging (2) 40% 5% United States US under-represented in Ipsen sales Reaching critical mass in the US is key to drive Group profitability 12 J.P. Morgan European Healthcare Conference 2014 (1) France, Germany, UK, Italy, Spain (2) Notably includes China, Russia and Brazil ( * ) Source: Ipsen estimates and IMS Health Market Prognosis, September 2013 (US$ spending with variable exchange rates)
Drivers to grow US presence Imminent GEP-NET ( * ) filing Somatuline Preparation for GEP-NET ( * ) commercial launch Continued penetration of the acromegaly market AUL (1) spasticity filing expected H2 2014 Dysport ALL (2) and PLL (3) topline data expected end of 2014 Galderma to potentially distribute Dysport in aesthetics Increlex Step forward in market resupply with FDA approval to release one batch Release of additional lots anticipated 13 J.P. Morgan European Healthcare Conference 2014 (1) Gastro-entero-pancreatic neuroendocrine tumors (1 ) Adult upper Limb (2) Adult Lower Limb (3) Pediatric Lower Limb
2014 outlook
Primary care Specialty care In Q1 2014, strong specialty care performance driven by Somatuline and return to growth of Decapeptyl Drug sales Q1 2014 in million euros % excluding foreign exchange impact Decapeptyl +5.9% 73.8 Somatuline Dysport Nutropin +13.0% 15.8 +6.3% +13.0% 60.8 68.5 Specialty care 225.3m +6.4% Hexvix 4.4 +10.5% Increlex Smecta 2.0 (67.8%) +4.1% 30.2 Drug sales 301.9m +4.3% Tanakan Forlax Fortrans (0.4%) (4.9%) 8.4 5.3 (1.2)% 16.3 Primary care 76.6m (1.7%) Increlex resupply resumed in Europe, progressing in the US 15 J.P. Morgan European Healthcare Conference 2014
2014 financial objectives Specialty care Drug sales Growth of +4.0% to +6.0%, year-on-year Driven by normalization of situation in China, in a context of continued pricing pressure and uncertainty on Increlex US resupply Primary care Drug sales Decline of -2.0% to 0.0%, year-on-year Excluding the launch of a Smecta generic in France Between 16.0% and 17.0% of sales Recurring Adjusted (1) operating margin In 2014, Ipsen will continue to implement operating efficiency measures The Group notably strives to limit the profitability impact of launching Somatuline NET in the US 16 J.P. Morgan European Healthcare Conference 2014 Note: All the above objectives are set at constant currency and exclude major negative unforeseeable events, for instance the deterioration in the economic environment in Ukraine (1) Prior to non-recurring elements
Moving parts to impact 2014 EBIT Illustrative chart Evolution of EBIT margin at constant currency Contribution topline growth FY13 EBIT (1) margin Full year impact of France PC restructuring Full year impact of US restructuring Cost saving initiatives R&D investment Cost inflation NET investment In the US FY14 EBIT (1) margin 17% [16%-17%] FY 2013 FY 2014 Improved cost control to offset cost inflation and NET US investment 17 J.P. Morgan European Healthcare Conference 2014 Note: The chart is for illustrative purposes only (1) Recurring adjusted (i.e. prior to non-recurring elements)
Major R&D and regulatory milestones to come in 2014 H1 2014 H2 2014 2015 R&D Dysport NDO Full PhII data Dysport NG PhIII (CD) and PhII (GL) Dysport AUL Full PhIII data Tasquinimod mcrpc PhIII results (PFS and OS data) Tasquinimod (HCC, RCC, Gastric & Ovarian) PhII results (1) Dysport PLL PhIII topline data Dysport ALL PhIII topline data TasQ maintenance study PhIIa (POC) results Dysport AUL US launch DNG regulatory feedback Regulatory/ Commercial Dysport AUL US filing Somatuline GEP NETs WW filing Somatuline GEP NETs Preparation for US launch Somatuline GEP NETs WW launch 18 J.P. Morgan European Healthcare Conference 2014 Note: NDO: Neurogenic Detrusor Overactivity, GL: Glabellar Lines, CD: Cervical Dystonia, AUL: Adult Upper Limb, HCC: Hepatocellular Carcinoma, RCC: Renal Cell Carcinoma, PLL: Pediatric Lower Limb, ALL: Adult Lower Limb (1) Provided that all futility analyses are completed
In 2014, continued business development efforts to complement organic growth Areas of focus Commercial deals In-licensing or acquisition of marketed drugs Acquisition of small companies Various geographies targeted, notably the US R&D deals Late stage compounds (Phase III) in various therapeutic areas Early stage compounds (Phase I and II) with a potential for breakthrough innovation 19 J.P. Morgan European Healthcare Conference 2014
Key takeaways 2013 Strong operating performance and major clinical successes setting the stage for future growth 2014 TasQ phiii clinical results, preparation of NET US launch and continued operating efficiencies 20 J.P. Morgan European Healthcare Conference 2014