BioGaia a healthcare company working with probiotics

Transcription

1 BioGaia presentation March

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 90 markets through distributors Contract manufacturing (TwoPac AB 100% owned) Holds 400 patents in 31 families The founders Peter Rothschild och Jan Annwall 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 Suppliers Contract Manufacturing 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

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 7

8 Bran Brand Branding for Health professionals Sold in 50 countries 61% of sales 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 Lactobacillus reuteri Protectis, Prodentis and Gastrus 137 completed clinical trials in individuals 97 randomised, double-blind / blind, placebo-controlled studies in subjects 41 open studies in subjects 45 studies in 0-3y in subjects 108 scientific articles and 9 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=0.127 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 13

14 Prevention? 14

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

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 16

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) 17

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

19 Attractive and unique formulations and packaging solutions 19

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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, U.S and UK Powder formula for children above the age of one 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: 14% Sales % % -8% +9% % Sales ) ) 1) Excluding licence revenue from Nestlé of 356 MSEK / 95,4 MSEK 24

25 Sales per geographical market 2014 Europe 67% (69) USA and Canada 8% (7) Asia 10% (13) Rest of world 15% (11) 25

26 Income statement 2014/2013 Excluding Excl Licence rev. currency effect: Net sales Paediatrics 313,7 313,7 238,6 31% 27% Net sales Adult Health 69,5 69,5 75,6-8% -12% Net sales other 3,2 3,2 1,7 Licence revenue 95,4 - - Total sales 481,8 386,4 315,9 22% 18% Cost of goods sold -131,3-131,3-101,7 Gross profit 350,5 255,1 214,2 19% Gross margin 73% 66% 68% Operating expenses BioGaia -154,7-154,7-134,3 15% Operating expenses IBT -6,6-6,6 - Exchange gain/loss on operation 7,7 7,7 1,8 Operating profit 196,9 101,5 81,7 24% 13% 1) Operating margin 41% 26% 26% Operating margin excl IBT 42% 28% 26% Exchange gain/loss on forward exchange contracts -6,6-6,6-2,9 Interest income 2,2 2,2 5,0 Profit before tax 192,5 97,1 83,8 16% Profit margin 40% 25% 27% Tax -44,5-23,5-19,6 Profit after tax 148,0 73,6 64,2 15% 1) 21 % excluding IBT expenses and currency effects 26

27 Balance sheets (MSEK) Dec, 31 Dec 31, Assets Intangible assets 6,1 - Tangible assets 72,8 60,3 Other financial assets 4,0 - Current assets 122,0 88,8 Cash and cash equivalents 210,7 234,3 Total assets 415,6 383,4 Equity and liabilities Equity attributable to owners of the Parent company 344,5 317,3 Non-controlling interets 0,1-0,5 Total equity 344,6 316,8 Deferred tax liability 0,2 0,1 Other provisions 3,9 - Interest-free current liabilities 66,9 66,5 Total equity and liabilities 415,6 383,4 Proposed dividend: SEK 5.00 per share 27

28 5 years development (2012 and 2014: excluding licence revenue from Nestlé) Total sales Gross profit Operating expenses (cost of goods excluded) Operating result Profit before tax *) *) 28

29 Key events 2014 Publication of study showing that colic can be prevented No significant differences in BioGaia s diabetes study New extended agreement with Nestlé Publication of study showing that it is possible to prevent common infections in children Agreement for the sale of drops in the UK and India Decision to extend production plant in Eslöv Publication of study showing that infants with colic cry less with BioGaia s drops Publication of study showing that BioGaia Protectis tablets are effective in constipated adults Investment in MetaboGen AB 29

30 Board of Directors 2014 Paula Zeilon Stefan Elfving Chairman David Dangoor Jörgen Thorball Ingrid Holmström Jan Annwall Jan Litborn Brit Stakston 30

31 Major Shareholders 31 December, 2014 A shares B shares Share capital No. of votes Capital Votes SEK 000's 000's % % 000's 000's 1 Annwall & Rothschild Inv. AB ,7% 34,1% 2 Sebastian Jahreskog ,3% 5,3% 3 Fjärde AP-fonden ,0% 2,9% 4 JPM Chase NA ,0% 2,9% 5 David Dangoor (inkl bolag) ,3% 2,4% 6 Nordea Investment Funds ,2% 2,3% 7 Handelsbanken Fonder AB ,1% 2,2% 8 Banque Pictet & CIE, W8IMY ,9% 2,1% 9 Six Sis AG W8IMY ,5% 1,8% 10 State Street Bank & Trust com., Boston ,4% 1,7% Other shareholders ,6% 42,3% Total: % 100% Total number of shareholders 31 December, 2014: 7,136 Foreign owners: 47% of capital (34% of votes) 31

32 Probiotic supplements global market Probiotic supplements historic global sales and projections (in billions $) Probiotic supplements global sales Euromonitor International

33 Launches - Drops: Launched in 71 countries - Tablets: Launched in 57 countries - ORS: Launched in 14 countries - Oral health products: Launched in 22 countries 33

34 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: UK, India, China, South Korea White spots: Vietnam, Myanmar, Thailand, Netherlands 34

35 Present focus US, UK and India Launch of new packaging solutions Development program for fermentation and freeze-drying A number of projects, studies and product developments with Nestlé Manufacturing process, planning for Phase 2 trial and financing for NEC-product TwoPac to be GMP qualified opens some Asian markets Strategic planning for MetaboGen 35