Increase in revenues in line with full-year targets (+1.2%) Very strong growth of Oralair exc. USA (+26%) ( ) H1 2014 revenues and results - 24 July 2014
Forward-looking statement This presentation contains forward-looking statements, including forecasts of future revenue and operating profit as well as expected business-related events. Such statements are based upon the current beliefs and expectations of Stallergenes management and are subject to risks and uncertainties. Actual results may differ from those set forth in the forward-looking statements, due to various factors. Without being exhaustive, such factors include economic situations and business conditions, notably legal and product evaluation issues, fluctuations in currencies and demand, changes in competitive factors and reliance on suppliers. 2
H1 2014 Highlights Growth and profitability maintained Revenues: 130.3 m (+1.2%) Oralair exc. U.S: 18.1 m (+26%) EBITDA: 42.3 m (32.6% of sales) Net Cash Flow: 29.4 m (+121% vs last year) U.S: 1 st patients treated with Oralair in May, several thousand people have already yjoined support programs 2014 guidance: Confirmation of revenue and increase of EBITDA guidance In July, continued international expansion with the acquisition of ALERGO PHARMA S.R.L in Argentina 3
H1 2014: Stallergenes growth driven by North and Central Europe and international markets Net Sales per geographic segment (in m) 128.7m +1.0% 130.0m +22.3% +3.1% 8.2m 0.25m 30.5m International markets: Strong sales performance confirms our expansion strategy Market leader in Australia, Middle-East, and Russia, where performance is largely driven by increased prescriber and patient base -1.5% 91m North and Central Europe: Growth driven by Eastern Europe H1 2013 H1 2014 International markets USA North & Central Europe Southern Europe Southern Europe: France: Successful new pump launch Oralair reaches market leadership Revision of business model patterns in Italy & Spain to reflect difficult economic conditions 4
Major on-going projects DIVERSIFY in allergies EXPAND in asthma MAXIMISE our current business New innovative technologies (DBV Technologies, ActoGeniX) HDM tablet (STG320) in asthma (ongoing ph.ii study) Foster patients capture and retention Staloral sales acceleration through the launch of the new pump and sustained efficacy data on birch Oralair : Continuous double digit growth (+26%) HDM tablet (STG320) in Allergic Rhinitis: Positive ph.iii study results and Marketing authorization filed in Japan International expansion 5
Major on-going projects New innovative technologies (DBV Technologies, ActoGeniX) DIVERSIFY in allergies HDM tablet (STG320) in asthma (ongoing ph.ii study) EXPAND in asthma Foster patients capture and retention MAXIMISE our current business Staloral sales acceleration through the launch of the new pump and sustained efficacy data on birch Oralair : Continuous double digit growth (+26%) HDM tablet (STG320) in Allergic Rhinitis: Positive ph.iii study results and Marketing authorization filed in Japan International expansion 6
Oralair : Continuous double digit growth (+26%) Oralair : The 5 grass pollen tablet demonstrated efficacy with pre & coldiscontinued dregimen seasonal The fastest growing g AIT tablet (x20 in 6 years) Oralair gains market leadership in France in one year A major advancement in AIT treatment in the U.S A new springboard to leverage our positions in high potential countries: Turkey: Marketing Authorization granted Canada & Belgium: better reimbursement conditions 7
Oralair : The fastest growing AIT tablet Oralair revenues since launch (m ) Oralair market share 1 : 47% (MAT Apr. 2014) 20 +4 pts vs. Apr. 2013 x20 22.2 16.2 14.4 +26% 18.1 15 12.2 10 7.6 5 3.1 0.4 0 2008 2009 20100 2011 20122 2013 YTD H1 2013 YTD H1 2014 1. IMS data: only countries where both Oralair and Grazax have been launched w/o US. In MAT: Moving Annual Turnover in value 8
Oralair : AIT tablet sales leader in France just one year post launch Grasses tablet t Sales Grasses Tablet Market Share + 1,9 M +50% 3.7 M 5.6 M Oralair 3.0 M Oralair 39% +15% Oralair 54% Oralair 1.5 M +107% Grazax 2.3 M +13% Grazax 2.6 M Grazax 61% 15% Grazax 46% YTD May 2013 YTD May 2014 Source : GERS YTD May 2013 YTD May 2014 Source : GERS in value Oralair has been launched in France 2 years after Grazax 9
AIT grass tablets gaining market share Worldwide AIT Grass pollen market evolution (TO)* 2011 2013 14% +7pts 21% 3pts 50% 47% 36% 4pts 32% Sublingual Tablets Subcutaneous Sublingual drops * W/o US and Japan Stallergenes internal estimates due to incomplete available data 10
USA: Oralair now available for US patients Oralair approved by the FDA on April 1, 2014 Oralair is the first and only 5-grass tablet immunotherapy tablet with a pre-co seasonal protocol approved in the U.S for the treatment of grass pollen allergy Oralair launched on May 5, 2014 by Greer Laboratories Inc., a leader in allergen immunotherapy in the U.S Oralair is currently being reimbursed by the top U.S. payors representing more than 160 million covered lives Several thousand patients joined allergy patient support programs 11
Oralair : The 5 grass pollen tablet demonstrated efficacy with pre & co-seasonal discontinued regimen 15 1,5 Daily Combined Score Daily Combined Score (DCS) Placebo 5-Grass Pollen Tablet ± standard error 1,0 p=0.0024 Treatment period Post-treatment period LS mean 0,5-16.4% p<0.0001-38.0% p<0.0001-38.3% p=0.0103-25.3% p=0.0478-28.1% 0,0 067 0,67 056 0.56 056 0,56 035 0.35 050 0,50 031 0.31 051 0,51 038 0.38 038 0,38 027 0.27 n = 205 188 172 160 165 149 155 143 133 127 Year 1 Year 2 Year 3 Year 4 Year 5 V053 - Didier A. Abstract EAACI 2014 Sublingual five-grass pollen tablets (Oralair): a guide to their use as allergen immunotherapy for grass pollen-induced allergic rhinoconjunctivitis Katherine A. Lyseng-Williamson - Drugs Ther Perspect DOI 10.1007/s40267-014-0131-7 Springer International Publishing Switzerland 2014 12
House Dust Mite AIT tablet (STG320): High potential development program Ongoing major development in allergic rhinitis: House Dust Mite AIT tablet (STG320), targeting the most prevalent cause of respiratory allergies in the world Japan Positive ph.iii study results Marketing Authorization filed U.S / E.U Phase III study IND submission by Q4 2014 13
Broadening STALLERGENES' geographic footprint Accelerating growth in our new AIT markets: Latin American acquisition: ALERGO PHARMA S.R.L The leader on the AIT market in Argentina Excellent market knowledge, an extensive distribution network and long standing relations with allergy specialists Broadens STALLERGENES' geographic footprint across the region 14
Financials a 15
Strong profitability including continuous geographic expansion & USA H1 2013 H1 2014 Change M % % % Net sales Total Revenues 128.7 128.7 100.0 100.0 130.0 130.3 100.0 100.0 +1.0 +1.2 Gross Margin 103.1 80.1 100.5 77.3 (2.5) SG & A (53.6) (41.7) (52.0) (40.0) (3.0) R&D cost (22.2) (17.2) (22.5) (17.3) +1.5 R&D revenue 9.0 7.0 11.1 8.5 +23.2 Current Op Result 36.33 28.22 37.1 28.5 2.1 Transformation (2.8) (2.2) (3.3) (2.6) 17.9 EBIT 33.5 26.0 33.7 26.0 0.8 Net Result 22.5 17.5 23.3 17.9 3.5 Current Operating result grows faster than Net Sales thanks to well managed Operating Expenses and higher R&D revenue and despite a deterioration in Gross Margin 16
Net Cash Flow up 121% H1 2013 H1 2014 Change M % EBIT 33.5 33.7 0.8 EBITDA 41.6 42.3 1.8 Operating income tax (11.3) (10.7) Working Capital variance (11.2) 4.6 Capital expenditures (5.0) (5.2) Free Cash Flow 14.11 31.0 119.8 Financing Activities (0.8) (1.6) Net Cash Flow 13.33 29.4 +121.0 Improved Net Cash Flow primarily thanks to a milestone payment from our Japanese partner 17
Debt to equity ratio up to 74% vs. 66% in prior year June 30, 2013 June 30, Change 2014 M % Non current assets 108.9 108.6 (0.3) Current assets 65.2 77.9 +19.6 Cash 109.2 141.9 +29.9 TOTAL ASSETS 283.3 328.4 +15.9 Shareholders equity 211.1 252.2 +19.4 Long term liabilities 7.1 6.7 (6.5) Short term liabilities 65.1 69.5 +6.9 TOTAL LIABILITY AND SHAREHOLDERS EQUITY 283.3 328.4 +15.9 18
Revised 2014 Guidance Revenues: Low single digit growth EBITDA: 28% of net sales 1 1 excluding non current income and expenses 19
Main takeaways Oralair expansion in the United States, a major market for future growth Strong product portfolio for the 3 main allergens (grass & birch pollen, house dust mites) Further international development, particularly in Latin America 2014 guidance: Confirmation of revenue and increase of EBITDA guidance 20