BioGaia a healthcare company working with probiotics

Transcription

1 BioGaia presentation June

2 BioGaia a healthcare company working with probiotics BioGaia s vision is to improve the health of people around the world by offering first class probiotic products. BioGaia s business concept is to develop, market and sell well-documented probiotic products worldwide in the form of innovative and convenient formulations 2

3 BioGaia AB Founded in employees Officies in Stockholm, Lund, Eslöv, Raleigh, Hiroshima, Shanghai Listed on the OMX Nordic Exchange in Stockholm 1998 Products in 85 markets through distributors Contract manufacturing (TwoPac AB 100% owned) Holds 300 patents in 27 families 3

4 Change of focus Oral Health Dietary Supplements Infant formula Functional Foods / Dairies Animal Health

5 BioGaia s global network Partners Pharma and Health Food companies BioGaia Product development, product strategies, research, Quality, market support Research Pre-clinical and clinical studies in hospitals and universities BioGaia Universities and hospitals where research is conducted. Manufacturing and Production Partners selling component products Partners selling finished goods 5 Suppliers Contract Manufacturing

6 Business model three networks Distribution partners Sales force Pharmacies Physicians Product development Innovation & IPR Product strategies Research Quality systems Marketing support Indications Clinical Research Preclinical Food supplements Production Probiotic cultures 6

7 Distribution partner network Local distributors with medical representatives who promote to health professionals Dietary supplement BioGaia BioGaia brand Sales through Pharmacies

8 Bran Brand Branding for Health professionals Sold in 50 countries 64% of sales (q1 2014) of finished products (incl. co-branding) Build value, less dependence on distributors and patents 8

9 Competition Strategy Engaged and competent personnel challenging existing solutions Clinical trials of high quality Attractive and unique formulations and packaging solutions Strong partner support 9

10 Clinical trials supporting the use of BioGaia Probiotics Including the strains L. reuteri Protectis, Prodentis and Gastrus 125 completed clinical trials in individuals 89 randomised, double-blind / blind, placebocontrolled studies in 8600 subjects 36 open studies in 1900 subjects 40 studies in 0-3y in 5500 subjects Results are published in 92 scientific articles and 7 doctoral theses.

11 Efficient BioGaia probiotics Functional gastrointestinal disorders Colic Regurgitation Constipation Functional abdominal pain Acute gastroenteritis Support of gastrointestinal health Antibiotic-associated side-effects Hp-infection Eradication treatment associated side-effects Gingivitis Periodontitis 11

12 Colic studies with L. reuteri Protectis Szajewska p=0.8 Placebo (n=40) L. reuteri Protectis (n=40) Reduction in median crying time after 21 days p=0.002** p< p< p< Ø Ø Ø Szajewska: 69% reduction with L. reuteri Protectis compared to 47% with placebo Savino: 90% reduction with L. reuteri Protectis compared to 70% with placebo Savino: 62% reduction with L. reuteri Protectis compared to 22% with simethicone Savino 2010 Savino p= * Placebo (n=21) L. reuteri Protectis (n=25) 200 p=0.987 p=0.005 Simethicone (n=42) L. reuteri Protectis (n=41) p= p<0.001 p<0.001 p< p=0.099 p= * Follow-up 1 week after termination of intervention

13 Cimperman et al, % reduction in diarrhoea incidence with L. reuteri Protectis compared to placebo Adults in hospital given a course of antibiotics were supplemented with L. reuteri Protectis or placebo for 4 weeks L. reuteri Protectis reduced incidence of diarrhoea by 84% compared to placebo

14 Prevention?

15 Gutierrez - Diarrhea in Preschool Children and L. reuteri Protectis L. reuteri Protectis (n=168) Placebo (n=168)

16 Study outcomes confirm previous results Reduced number of days: Gutierrez, 2014 (n=336) Weizman, 2005 (n=128) Agustina, 2012 (n=250) with diarrhoea with antibiotic use with fever NA absent from day care NA with respiratory tract infection NS NS

17 Indrio - Act and not React: Prophylactic use of L. reuteri Protectis in the Prevention of Colic, Regurgitation and Functional Constipation L. reuteri Protectis (n=238) Placebo (n=230)

18 Conclusions Ø Preventive use of L. reuteri Protectis in healthy newborns reduces onset of colic, regurgitation and constipation Ø Preventive use of L. reuteri Protectis reduces direct costs for both family and community Ø Preventive use of L. reuteri Protectis is proven to be valuable for both infants, parents and the society Indrio 2014.

19 Attractive and unique formulations and packaging solutions 19

20 BioGaia current products ProTectis Digestive Health ProDentis Oral Health Gastrus Stomach Health ProTectis ProTectis D3 ProTectis ProTectis ProTectis ProDentis ProDentis Gastrus Baby Baby Junior Baby/Junior Drops Drops Tablets ORS Tablets Drops Lozenges Tablets 20

21 BioGaia partner support Clinical trials Marketing and PR support BioGaia Academy Workshops Participation in medical congresses Speakers at symposiums Education of sales representatives Social media Customer support 24/7/365 21

22 Competitors Culture suppliers Chr Hansen DuPont (Danisco) Institut Rosell Lallemand (France) Probiotic strains Valio (Finland) Probi (Sweden) Functional Foods Danone Yakult Pharma Merck (Germany) Novartis Sanofi Aventis Ferrosan (Pfizer) Bayer (USA) Other P&G Local competitors 22

23 Cooperation with Nestlé Agreement 2008 (Infant formula) Agreement 2012 (EUR 50.8 million) Drops in Mexico and U.S New category of products (planned launch second half of 2014) Extended collaboration (SEK 92.0 million over three years from q2 2014, New segment) Other ongoing development projects 23

24 Sales development 5 years Average growth: 18% Sales 350,0 300,0 +33% +9% -8% *) 250,0 +16% 200,0 +40% 150,0 Sales 100,0 50,0 0, *) Excluding licence revenue from Nestlé of 356 MSEK 24

25 Sales development by segment- 5 years Finished consumer products average growth: 20% Component products average growth: 17% % +10% +8% % +16% Finished consumer products Component products % +28% +42% -48% *) +16% *) Excluding licence revenue from Nestlé 25

26 Sales per geographical market 2013 (MSEK) Europe 69% (70) USA and Canada 7% (10) Asia 13% (11) Rest of world 11% (9) 26

27 Sales per segment q q (rolling 12 months) (MSEK) (License revenue excluded) Finished consumer products Component products

28 Gross Margins per segment (MSEK) (License revenue excluded) 2013/2012 Gross margin per segment Finished consumer products 70% 72% Component products 57% 59% Total gross margin 68% 70% BioGaia Brand Sales of products of BioGaia brand (incl. co-branding ) amounted to 55% (51%) of finished consumer products during

29 Income statement 2013 vs 2012 Excl. Licence Licence revenue income incl Excl curr eff. Net sales Finished consumer products 256,2 237,6 237,6 8% 11% Licence revenue ,0 Net sales Component products 58,6 50,6 50,6 16% 17% Net sales Other products 1,1 1,1 1,1 0% Total sales 315,9 289,3 645,3 9% 12% Cost of goods sold -101,7-88,2-88,2 Gross profit 214,2 201,1 557,1 7% Gross margin 68% 70% 86% Operating expenses -134,3-126,6-126,6 6% Exchange gain/loss on operation 1,8-2,4-2,4 Operating profit 81,7 72,1 428,1 13% 16% Operating margin 26% 25% 66% Exchange gain/loss on forward exchange contracts -2,9 5,6 5,6 Interest income 5,0 8,6 8,6 Profit before tax 83,8 86,3 442,3-3% Profit margin 27% 30% 69% Tax -19,6-22,6-112,4 Profit after tax 64,2 63,7 329,9 1% 29

30 Balance sheet 31 December 2013/2012 (MSEK) Assets Dec 31, 2013 Dec 31, 2012 Tangible assets 60,3 49,2 Current assets 88,8 92,8 Cash and cash equivalents 234,3 375,0 Total assets 383,4 517,0 Equity and liabilities Equity attributable to owners of the Parent company 317,4 453,3 Non-controlling interets -0,5 3,5 Total equity 316,9 456,8 Deferred tax liability 0,1 24,7 Interest-free current liabilities 66,4 35,5 Total equity and liabilities 383,4 517,0 30

31 5 years development (2012: excluding licence revenue from Nestlé) Net sales Gross result Operating expenses Operating profit Profit before tax

32 Quarter

33 Income statement q vs q Exluding Excl. License rev. currency q q q effect: Net sales Paediatrics 76,7 76,7 61,2 25% 22% Net sales Adult Health 15,0 15,0 16,9-11% -13% Net sales other 1,5 1,5 0,0 Licence revenue 95,4-0,0 Total sales 188,6 93,2 78,1 19% 17% Cost of goods sold -31,7-31,7-26,2 Gross profit 156,9 61,5 51,9 18% Gross margin 83% 66% 66% Operating expenses -34,1-34,1-33,0 3% Exchange gain/loss on operation 1,0 1,0-1,1 Operating profit 123,8 28,4 17,8 60% 48% Operating margin 66% 30% 23% Exchange gain/loss on forward exchange contracts 0,1 0,1 3,1 Interest income 0,8 0,8 1,8 Profit before tax 124,7 29,3 22,7 29% Profit margin 66% 31% 29% Tax -27,7-6,7-5,0 Profit after tax 97,0 22,6 17,7 28% 33

34 Key events first quarter 2014 Publication of study showing that colic can be prevented No significant differences in BioGaia s diabetes study Additional payments from Nestlé Extended collaboration with Nestlé Publication of study showing that it is possible to prevent common infections in children 34

35 Board of Directors 2014 Paula Zeilon Stefan Elfving Chairman David Dangoor Jörgen Thorball Ingrid Holmström Jan Annwall Jan Litborn Brit Stakston

36 Major Shareholders 31 March 2014 A shares B shares Share capital No. of votes Capital Votes 000's 000's SEK 000's 000's % % 1 Annwall & Rothschild Inv. AB ,7% 34,1% 2 Banque Öhman S.A ,6% 6,2% 3 David Dangoor (inkl bolag) ,3% 2,4% 4 Nordea Investment Funds ,1% 2,2% 5 Pictet & CIE, W8IMY ,9% 2,1% 6 Six Sis AG W8IMY ,7% 1,9% 7 Futuris ,4% 1,8% 8 Fjärde AP-fonden ,3% 1,7% 9 JPM Chase NA ,3% 1,7% 10 AMF-Försäkring och fonder ,2% 1,6% Other shareholders ,3% 44,3% Total: % 100% Total number of shareholders 31 March, 2014: 7,394 Foreign owners: 46% of capital (33% of votes)

37 Probiotic supplements global market 5,0 4,5 Probiotic supplements historic global sales and projections (in billions $) 4,3 4,0 3,5 3,0 2,8 2,5 Probiotic supplements global sales 2,0 1,8 1,5 1,0 0,5 0, Euromonitor International 2013

38 Launches and planned launches - Drops: Launched in 64 countries (contracts but not launched in 5-10 countries) - Tablets: Launched in 52 countries (contracts but not launched in 5-10 countries) - ORS: Launched in 7 countries (contracts but not launched in 6 countries) - Oral health products: Launched in 20 countries (contracts but not launched in 4 countries) 38

39 Growth potential existing products 3 or more products from our product line launched in only 21 countries out of 70 countries Drops per new-born (from 3% up to 434%, average 105%) Contract but not launched: China, South Korea, Brazil White spots: UK, India, Vietnam, Myanmar, Thailand, Netherlands 39

40 Present focus Continued focus on US, Russia, India and UK Launch in Brazil A number of projects, studies and product developments with Nestlé Manufacturing process for NEC-product 40