Ipsen 2016 Healthcare Conference

Transcription

1 Ipsen 2016 Healthcare Conference Jefferies - June 2016 IPSEN pour nom de la société - 07/04/2011 / page 1

2 Disclaimer This presentation includes only summary information and does not purport to be comprehensive. Forward-looking statements, targets and estimates contained herein are for illustrative purposes only and are based on management s current views and assumptions. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated in the summary information. Actual results may depart significantly from these targets given the occurrence of certain risks and uncertainties, notably given that a new product can appear to be promising at a preparatory stage of development or after clinical trials but never be launched on the market or be launched on the market but fail to sell notably for regulatory or competitive reasons. The Group must deal with or may have to deal with competition from generic that may result in market share losses, which could affect its current level of growth in sales or profitability. The Company expressly disclaims any obligation or undertaking to update or revise any forward-looking statements, targets or estimates contained in this presentation to reflect any change in events, conditions, assumptions or circumstances on which any such statements are based unless so required by applicable law. All product names listed in this document are either licensed to the Ipsen Group or are registered trademarks of the Ipsen Group or its partners. The implementation of the strategy has to be submitted to the relevant staff representation authorities in each country concerned, in compliance with the specific procedures, terms and conditions set forth by each national legislation. Safe Harbor The Group operates in certain geographical regions whose governmental finances, local currencies or inflation rates could be affected by the current crisis, which could in turn erode the local competitiveness of the Group s products relative to competitors operating in local currency, and/or could be detrimental to the Group s margins in those regions where the Group s drugs are billed in local currencies. In a number of countries, the Group markets its drugs via distributors or agents: some of these partners financial strength could be impacted by the crisis, potentially subjecting the Group to difficulties in recovering its receivables. Furthermore, in certain countries whose financial equilibrium is threatened by the crisis and where the Group sells its drugs directly to hospitals, the Group could be forced to lengthen its payment terms or could experience difficulties in recovering its receivables in full. Finally, in those countries in which public or private health cover is provided, the impact of the financial crisis could cause medical insurance agencies to place added pressure on drug prices, increase financial contributions by patients or adopt a more selective approach to reimbursement criteria. All of the above risks could affect the Group s future ability to achieve its financial targets, which were set assuming reasonable macroeconomic conditions based on the information available today. 2 Ipsen 2016 Healthcare Conference 2 Goldman Sachs 35th Annual Global Healthcare Conference June 2014

3 Agenda 1 Overview 2 Key 2016 events financial performance 3 Ipsen 2016 Healthcare Conference 3 Goldman Sachs 35th Annual Global Healthcare Conference June 2014

4 Overview

5 Ipsen, an international specialty pharma company Q sales by segment Q sales by geography Top 5 affiliates ~20% Primary care Europe G5 39% 32% Emerging markets 1 France 2 US Specialty care ~80% 14% Developed RoW 15% US 3 China 4 Germany 5 Italy One of the largest emerging market presence in the industry Consolidating US footprint 5 Ipsen 2016 Healthcare Conference 5 Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: ROW: Rest of World

6 A refocused strategy to sustain high sales and profit growth Specialty care Primary care Lead NET Spasticity Dysport aesthetics Optimize Smecta Forlax Tanakan Reinforce Urologyoncology Adult endocrinology Diversify Adjacent GI Probiotics Explore GI/orphan cancers Expand Geographies Niche strategy Move to OTx commercial model 6 Ipsen 2016 Healthcare Conference 6 Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: GI:Gastrointestinal; OTx:Dual channel approach (Rx/OTC); NET: Neuroendocrine tumors

7 Key 2016 events

8 2016 roadmap Position Somatuline as a leader in NET and secure Dysport spasticity launch Implement new Primary Care OTx model, notably in China Prepare the commercial launch of Cabozantinib for the treatment of Renal Cell Carcinoma in Europe Continue Business development to replenish pipeline and complement marketed product portfolio Implement new corporate governance model 8 Ipsen 2016 Healthcare Conference 8 Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: OTx: Dual channel approach (Rx/OTC); NET: Neuroendocrine tumors

9 Q sales driven by strong Somatuline performance Drug sales Q in million euros % excluding foreign exchange impact Somatuline +36.3% 122 Specialty care Decapeptyl Dysport Nutropin Increlex Hexvix (4.6%) 78 Specialty care 288.1m (4.2%) % (3.8%) % +3.6% Group sales 362.0m +4.7% Primary care Smecta Forlax Tanakan +11.5% (4.1%) (16.9%) France: (3.6%) International: (13.7%) Primary care 73.9m (11.0%) Decapeptyl and Smecta impacted by stocking effects, notably in China Dysport aesthetics impacted by stocking effects through Galderma partnership 9 Ipsen 2016 Healthcare Conference 9 Goldman Sachs 35th Annual Global Healthcare Conference June 2014

10 Exclusive license agreement with Exelixis for Cabozantinib, with key indication in Renal Cell Carcinoma (RCC) Exclusive global licensing and commercialization rights (ex North America & Japan) Key indications Medullary Thyroid Cancer Marketed Marketed Renal Cell Carcinoma Filed in 2 nd line Hepatocellular Carcinoma Ph3 in 2 nd line European incidence 1,500 patients 110,000 patients 60,000 patients Potential development in further indications 10 Ipsen 2016 Healthcare Conference 10 Goldman Sachs 35th Annual Global Healthcare Conference June 2014

11 Cabometyx, first therapy to show 2L RCC clinically meaningful improvement in OS, PFS and ORR 1 st line RCC Standard of care: TKIs 2 d line RCC Approved therapies TKIs mtor inhibitors New entrants Cabometyx Opdivo FDA-approved April 25 th, 2016 FDA-approved November 23 rd, 2015 Afinitor PFS OS ORR Value (1) HR Value (2) (3) (3) HR 0.58 Value (2) HR % 2 pts 21% (4) 16 pts 25% (4) pts RCC 2 nd line treatment paradigm shift from PFS to OS (1) Motzer RJ et al. Efficacy of everolimus in advanced renal cell carcinoma: a double-blind, randomised, placebo-controlled phase III 11 Ipsen 2016 Healthcare Conference trial (2) FDA Package Insert (3) vs Everolimus (4) as published in the NEJM. Note : mtor: Mammalian Target Of Rapamycin; ORR: 11 Goldman Sachs 35th Annual Global Healthcare Objective Conference Response June Rate; 2014 OS: Overall survival, PFS: Progression Free Survival; RCC: Renal Cell Carcinoma; TKI : Tyrosine Kinase Inhibitors

12 Strong rationale for Cabozantinib in-licensing Acquire a potential best in class derisked asset in attractive niche RCC with solid scientific data triggering treatment paradigm shift Completion of a global oncology therapeutic footprint (US and Europe) Reinforce Ipsen portfolio in niche oncology with potential for further development in other indications Accelerate specialty care growth in the next 5 years with a 4 th pillar added to Ipsen Specialty portfolio 12 Ipsen 2016 Healthcare Conference 12 Goldman Sachs 35th Annual Global Healthcare Conference June 2014 RCC: Renal Cell Carcinoma

13 Cabozantinib, deal terms and impact on Ipsen operations Milestones Upfront: $200m Regulatory: up to $110m for identified indications ($60m for 2L RCC expected H and $50m for 2L HCC expected 2018). Additional milestones agreed for further indications Commercial: up to $545m Royalties During the initial launch period: 2% on first $50 million net sales 12% on next $100 million net sales Thereafter: 22% to 26% on net sales Operations Transfer of MTC Market Authorization in H and 2L RCC launch starting in 2017 Significant commercial investment to build oncology sales organization starting in H impacting launch period, to be minimized by cost containment and project prioritization initiatives 13 Ipsen 2016 Healthcare Conference MTC: Medullary Thyroid Cancer, RCC: Renal Cell Carcinoma 13 Goldman Sachs 35th Annual Global Healthcare Conference June 2014

14 2016 financial objectives Specialty care sales Growth > 10.0%, year-on-year At constant currency Primary care sales Slight growth, year-on-year At constant currency Core Operating margin Around 21% of sales Including a negative impact of: ~150 basis points resulting from the investment required to prepare the commercial launch of Cabozantinib for the treatment of Renal Cell Carcinoma in Europe ~100 basis points from foreign exchange rates 14 Ipsen 2016 Healthcare Conference 14 Goldman Sachs 35th Annual Global Healthcare Conference June 2014

15 Update of 2020 financial outlook Group sales > 7% Core Operating margin >+370bps 1.4bn > 2.0bn Specialty care > 26% Specialty care >8% 22.3% Primary care [2% to 4%] CAGR Primary care E E 2020 Sales target increased to reflect Cabozantinib sales contribution 2020 Profitability target confirmed 15 Ipsen 2016 Healthcare Conference 15 Goldman Sachs 35th Annual Global Healthcare Conference June 2014

16 2015 financial performance

17 2015 sales and Core Operating Income strong performance in line with market guidance Specialty Care - Drug sales (2) guidance (1) actuals 14.0% +14.4% Primary Care - Drug sales (2) [-3.0% ; 0.0%] -1.1% Core Operating margin (as percentage of sales) 22.0% 22.3% 17 Ipsen 2016 Healthcare Conference 17 Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) Revised on 31 July 2015 (2) Year-on-year sales growth at constant currency

18 Turnaround of the US platform, with high potential for growth Renewed management and Salesforce (NET & spasticity) Successful Somatuline NET launch and preparation of Dysport AUL spasticity launch Strong Dysport aesthetics performance from Galderma US affiliate sales growth (1) 64.9% Somatuline US sales growth 111.9% 11.5% 31.2% 18.6% 28.6% US operations profitable in 2015, ahead of plan (1) Ipsen 2016 Healthcare Conference Restated for Increlex 18 supply interruption 18 Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: All growth rates at constant currency; AUL: Adult Upper Limbs; NET: Neuroendocrine tumors;

19 Strong Somatuline 2015 performance, driven by successful NET launch Business update Geographic distribution (2015) US: Ipsen present in >1 000 accounts, including all 25 major reference centers 42% 28% 18% 12% Europe: GEP NET approval granted by all European countries Increased penetration across geographies G5 (1) United States Developed RoW Emerging markets (2) 2015 performance Overall acceleration of growth due to NET global launch Strong growth in North America, up 112% with positive price impact Double digit growth in Europe, notably in Germany, the UK, Poland and France 3-year growth % +16.8% Ipsen 2016 Healthcare Conference 19 Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) France, Germany, UK, Italy, Spain (2) Notably includes China, Russia and Brazil Note: all variations at constant exchange rate; NET: Neuroendocrine tumors;

20 Somatuline accelerated NET penetration in the US and Europe Somatuline US quarterly data, all indications Somatuline Europe G5 (1) quarterly data, all indications Ipsen reported sales ($m) Market share (2) (%) Ipsen reported sales ( m) Market share (2) (%) % 12.8% Q Q Q Q Q Q Q Q Q Q Somatuline capturing majority of new patients in US and Europe Increased number of switched patients Ipsen 2016 Healthcare Conference Source: IMS MIDAS + Symphony Healthcare. 20 (1) G5: France, Germany, UK, Spain, Italy (2) Market share in volume 20 Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: Market definition = long-acting SSAs; NET: Neuroendocrine tumors;

21 Dysport 2015 performance driven by aesthetics Business update Q3 US launch of Dysport in AUL spasticity and sales force build-up Setup of European business unit for therapeutics Galderma partnership expanded to key Asia Pacific territories (1) Geographic distribution (2015) 18% 12% 25% 45% G5 (1) Developed RoW United States Emerging markets (2) 2015 performance 3-year growth Strong Galderma performance in aesthetics in a solid underlying market growth Solid performance in emerging markets, notably in Russia, Brazil and Australia +8.6% +9.7% Strong US Q4 driven by aesthetics & spasticity launch (1) China, India, South Korea (and Indonesia under certain conditions) (2) France, Germany, UK, Italy, Spain (3) Notably 21 Ipsen 2016 Healthcare Conference includes China, Russia and Brazil 21 Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note : all variations at constant exchange rate; AUL: Adult Upper Limbs

22 Dysport US market share in aesthetics increasing since Galderma takeover Dysport / Xeomin market share (%) Botox market share (%) 35% 90% 30% Botox ~73% 80% 25% 70% 20% ~22% 60% 15% Dysport 50% 10% 5% ~5% 40% Xeomin 0% Feb 10 Jun 10 Oct 10 Feb 11 Jun 11 Oct 11 Feb 12 Jun 12 Oct 12 Feb 13 Jun 13 Oct 13 Feb 14 Jun 14 Oct 14 Feb-15 Jun-15 Oct-15 30% Dysport US market share in excess of 20% thanks to Galderma s commercial push 22 Ipsen 2016 Healthcare Conference 22 Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Source: GuidePoint - Filler & Toxin Panel

23 Positive Decapeptyl growth in 2015, despite emerging markets headwind Business update Launch of 3-month subcutaneous formulation in Europe from July 2015 Progress on potential combination in breast cancer Increased commercial focus in China with dedicated sales force per indication Geographic distribution (2015) 48% 9% 43% G5 (1) Developed RoW Emerging markets (2) 2015 performance 3-year growth Q4 growth recovery in China after first 9 months affected by market slowdown and pricing pressure Price pressure across Europe and Algeria % % 334 High penetration in Spain with favorable share of voice to competitors Ipsen 2016 Healthcare Conference 23 Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) France, Germany, UK, Italy, Spain (2) Notably includes China, Russia and Brazil Note: all variations at constant exchange rate

24 Primary care resilient thanks to international market growth Business update Geographic distribution (2015) Start of Tanakan local production in Russia Launch of Smecta ready-to-use (liquid) and Strawberry taste in Q in France Accelerated switch of China primary care model to OTx with recruitment of 100 additional reps in % 5% 65% G5 (1) Developed RoW Emerging markets (2) 2015 performance Smecta sales impacted by new manufacturing setup in Algeria and destocking in distribution and price pressure in China year growth Tanakan facing out of pocket market slowdown and tough competition in Russia and France (4.8)% (1.1)% Solid performance of Etiasa in China and Fortrans notably in Russia Ipsen 2016 Healthcare Conference 24 Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) France, Germany, UK, Italy, Spain (2) Notably includes China, Russia and Brazi Note: all variations at constant exchange rate; OTx:Dual channel approach (Rx/OTC)

25 P&L - From sales to Core Operating Income in m FY 2015 FY 2014 Change % Change Change at constant FX Net sales 1, , % +10.4% Other revenues % Revenue 1, , % Cost of goods sold (336.8) (310.0) % R&D expenses (192.6) (186.9) % Selling expenses (541.4) (464.1) % G&A expenses (122.9) (111.2) % Other core (4.1) NA Core Operating income % Core Operating margin 22.3% 20.4% +1.9 pt Operating leverage driving margin expansion 25 Ipsen 2016 Healthcare Conference 25 Goldman Sachs 35th Annual Global Healthcare Conference June 2014

26 Ipsen exposure to foreign currencies 2015 sales exposure by currency 1,443.9 million Evolution of major currencies vs. EUR Average rates change (2015vs. 2014) GBP Other (1) 18% 19.9% 17.6% 11.1% 5% CNY 10% 17% USD 50% EUR -15.4% -25.3% USD CNY GBP RUB BRL Foreign Currency policy 2015 sales growth benefited from strong USD, CNY and GBP appreciation versus euro 2016 sales to be impacted by depreciation of emerging countries currencies (BRL, CNY, RUB) Global FX exposure mitigated by cost base in local currency and hedging of key currencies 26 Ipsen 2016 Healthcare Conference 26 Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) Includes RUB, BRL, AUD, PLN and other currencies

27 Drivers for operating cost evolution COGS ( m) +8.7% R&D ( m) +3.0% % 23.6% 24.3% 23.3% 14.7% 13.3% FY 2014 FY 2015 Positive mix effect, manufacturing efficiencies FY 2014 FY 2015 Impact of TasQ studies discontinuation Selling expenses ( m) G&A ( m) +16.7% % % 37.5% 8.7% 8.5% FY 2014 FY 2015 Impact of US investment (NET, spasticity) FY 2014 FY 2015 Support functions, variable compensation 27 Ipsen 2016 Healthcare Conference 27 Goldman Sachs 35th Annual Global Healthcare Conference June 2014 Note: All ratios in percentage of sales; NET: Neuroendocrine tumors

28 P&L - From Core Operating Income to EPS in m FY 2015 FY 2014 Change % Change Net sales 1, , % Core Operating income % Core Operating income margin 22.3% 20.4% +1.9 pt Other non core (7.2) (9.2) +2.0 Restructuring costs (6.7) (21.9) Impairment gain / (losses) (64.6) (8.0) Operating income % Financial result (6.4) (15.1) +8.7 Income taxes (49.8) (53.8) +4.0 Share of profit from JV Discontinued operations 0.5 (0.5) +1.0 Consolidated net profit % Consolidated profit margin 13.2% 12.1% +1.1 pt EPS fully diluted ( ) % Core EPS fully diluted ( ) % Consolidated net profit up 24% after TASQ impairment charge and exceptionally low tax rate 28 Ipsen 2016 Healthcare Conference 28 Goldman Sachs 35th Annual Global Healthcare Conference June 2014

29 Solid cash generation to finance capex, BD and return to shareholders through dividend & share buy-back In million euros Free cash flow: 156m Operating cash flow (1) Change in working capital (1) -61 Capex Opening cash Restructuring Dividends Share Buyback -29 BD & milestones -39 Other +16 Closing cash Dec Dec 2015 Closing cash up 34m vs 2014 Strong cash generation to self-finance acquisitions 29 Ipsen 2016 Healthcare Conference 29 Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) Excluding milestone amortization

30 Key financial takeaways Group sales up 10.4% at constant currency Strong Core Operating Income margin of 22.3% (1) Consolidated net profit of 190.7m, up 23.8% year-on-year Fully diluted core EPS of 2.78, up 25.2% year-on-year Closing cash balance of 214m, up 19% Proposal to maintain a dividend of 0.85 per share to support BD investment 30 Ipsen 2016 Healthcare Conference 30 Goldman Sachs 35th Annual Global Healthcare Conference June 2014 (1) In percentage of sales