Investor presentation. March 2017

Transcription

1 Investor presentation March

2 BioGaia AB 2 Founded in employees The founders Peter Rothschild and Jan Annwall Offices in Sweden (Stockholm, Lund, Eslöv), USA, Japan Contract manufacturing Products in 90 markets through distributors Holds 440 patents in 32 families Listed on the Nasdaq Stockholm (mid cap list)

3 BioGaia a healthcare company working with probiotics Mission: BioGaia performs research and development to provide clinically effective, healthful and user friendly probiotic products. Vision: BioGaia aims to be the groundbreaking leader in probiotics through: - Innovative research - Unique formulations and packaging - Excellence in IP - Global presence - Strong brand recognition - Social responsibility - Being an attractive workplace 3

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

6 BioGaia s partner support 6 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

7 BioGaia Brand Branding for Health professionals Sold in 60 countries 59% of sales of finished consumer products (drops, digestive health tablets, oral health tablets, oral rehydration solution) were sold under the BioGaia brand, including co-branding, in 2016 Build value, less dependence on distributors and patents 7

8 Intellectual Property Rights 440 issued patents in 32 families Trademarks in 66 countries + EU 70 Internet-domains 8

9 L. reuteri Protectis, Gastrus and Prodentis Clinically Proven Probiotics 9

10 Clinical trials supporting the use of BioGaia Probiotics Lactobacillus reuteri Protectis, Prodentis and Gastrus 163 completed clinical trials in 14,000 individuals 114 randomised, double-blind / blind, placebo-controlled studies in 10,500 subjects 47 open studies in 3,500 subjects 56 studies in 0-3y in 7,300 subjects 133 scientific articles and 10 doctoral theses Updated Sep

11 Clinical trials with all BioGaia probiotics in different age groups 163 completed clinical trials (48% children) in 14,031 individuals (71% children) 79 studies in 4,040 subjects 28 studies in 2,689 subjects 16 studies in 1,988 subjects 29 studies in 2,964 subjects 11 studies in 2,390 subjects Preterms Infants (0-12 mo, excl. preterms) Children (13-36 mo) Children (4-18 y) Adults (>18 y) Updated Sep

12 BioGaia Probiotics and Indications Functional gastrointestinal disorders PROTECTIS Colic Regurgitation Constipation Functional abdominal pain Acute gastroenteritis Support of gastrointestinal health Antibiotic-associated side-effects GASTRUS HP-infection Eradication treatment associated side-effects PRODENTIS Gingivitis Periodontitis 12

13 L. reuteri Protectis in infantile colic Five treatment studies showing beneficial effects Significant reduction of daily crying time Significantly higher number of responders Improved family quality of life Five meta-analyses with the same conclusion L. reuteri Protectis is the only probiotic proven effective in infantile colic One treatment recommendation Two prevention studies in healthy infants Significant reduction of daily crying time Fewer paediatric consultations Reduction in both public and private costs for managing functional gastrointestinal disorders 13

14 L. reuteri Protectis in functional constipation in children and adults Three treatment studies showing beneficial effect Increased bowel movements 100% normalization of stool frequency Equally effective as lactulose, with less side effects One systematic review L. reuteri Protectis the only probiotic with data on functional constipation in children One prevention study in healthy infants Significantly increased bowel movements when used preventively 14

15 L. reuteri Protectis in functional abdominal pain (FAP) Three double blind, randomized controlled treatment trials showing less stomach pain compared to placebo reduced severity of abdominal pain reduced frequency of abdominal pain One published systematic review L. reuteri Protectis the only probiotic with effect in FAP One Cochrane report supporting probiotic use in FAP 15

16 L. reuteri Protectis in acute gastroenteritis (AGE) Six treatment studies Reduced duration and severity of acute diarrhoea Less vomiting Significant effects from the second day of treatment Effects seen in both hospitalised and outpatient children Meta-analysis Significant reduction in the duration of diarrhoea ESPGHAN recommendation 2014 L. reuteri Protectis on the positive recommendation list for managing AGE 16

17 L. reuteri Gastrus in H. pylori therapy Two H. pylori related clinical studies showing significant effects: Reduced side effects and symptoms Reduced gastritis severity and activity Improved eradication rates 17

18 Clinical studies with L. reuteri Prodentis on Periodontitis Author, Year Teughels 2013 In patients with deep pockets supplementation of Lactobacillus reuteri Prodentis as an adjunct to SRP leads to significant reduction in the need for surgery Tekc e 2015 In patients with deep pockets supplementation of Lactobacillus reuteri Prodentis as an adjunct to SRP leads to additional PD reduction of 1 mm at 1-year follow-up Ince 2015 Adjuvant probiotic therapy provides additional benefit over initial periodontal therapy on clinical and biochemical parameters over 180 days. Szkaradkiewicz 2013 L. reuteri induces in most of the patients with chronic periodontitis a significant reduction in proinflammatory cytokine response and improvement of clinical parameters Vicario 2012 Vivekananda Results L. reuteri supplementation in patients with initial- to-moderate chronic periodontitis resulted in significant improvements in clinical conditions compared with placebo. L. reuteri Prodentis is suggested as an addition to mechanical debridement and during the maintenance phase of periodontal treatment.

19 Clinical studies with L. reuteri Prodentis on gingivitis and otheroral symptoms Author, Year Schlagenhauf Results Supplementation of L. reuteri Prodentis significantly reduced inflammation and plaque compared to placebo in 45 pregnant women with gingivitis. Kraft-Bodi 2015 Daily use of L. reuteri Prodentis reduces the prevalence of oral Candida in frail elderly patients. Stensson 2013 Daily supplementation with L. reuteri from birth and during the first year of life is associated with reduced caries prevalence and gingivitis score in the primary dentition at 9 years of age. Romani 2015 L. reuteri Prodentis delays regrowth of caries-associated Streptococcus mutans after full-mouth disinfection. Keller 2012 Daily use of L. reuteri Prodentis showed beneficial effect on oral malodour assessed by organoleptic scores. Çaglar 2008 The probiotic lozenge containing L. reuteri Prodentis significantly reduced salivary Streptococcus mutans streptococci.

20 Nestlé cooperation and Subsidiaries 20

21 Cooperation with Nestlé Agreement 2008 (Infant formula) New licence agreement infant formula 2012 (EUR 50.8 million) Drops in the US Growing Up Milk for children above the age of one (Royalty agreement 2013, launch end of 2014) Extended collaboration (Royalty SEK 92.0 million over three years from q2 2014) (New segment) Other on-going development projects 21

22 TwoPac AB (100% owned by BioGaia) 22

23 MetaboGen (36% owned by BioGaia) is creating new opportunities for novel therapeutics and next generation probiotics We use the microbiome to understand more about health and disease. 23

24 (90.1% owned by BioGaia) Providing innovative packaging solutions allowing the development of new unique beverages Exclusive LifeTop Cap and LifeTop Straw supplier 24

25 Our Market and Our Competitors 25

26 Our Market: Global probiotic supplement market 2015 ($ 3.8 billion) 0,1 0,6 1,9 1,2 America EU Asia Pacific Rest of world International Probiotics Association 2015, Euromonitor International

27 Our Market: Global probiotic supplement sales (Sales 2015 projected to 2020) 5, , , Sales ($ in billion) From 2015 to 2020, CAGR of 7,4% assumed according report from Global Market Insight 27 International Probiotics Association 2013 & 2015, Global Market Insights 2016

28 BioGaia Competitors Companies developing, producing, and selling probiotics (Probi) Well studied probiotic strains (L. GG from Valio) Non probiotic products/ drugs (Imodium, Simethicone (Minifom)) Probiotic products with strong brands (Enterogermina) Pharma companies (Sanofi) Functional Food (ProViva) 28

29 Importance of strain specificity Probiotic bacteria Car Group Lactic acid bacteria German car Genus Lactobacillus Volkswagen Species Lactobacillus reuteri VW Golf Strain L. reuteri Protectis VW Golf 2.0 Turbo Different breeds have different characteristics and are suitable for different tasks VW Golf I and the VW Golf VI GTI, similar cars, but you do not expect the same output Try convincing your teenage daughter that an iphone 3 is just as good as an iphone

30 Our Sales Development and Our Market Presence 30

31 Sales (Average growth: 11%) Sales % +11 % % 300-8% +9 % Sales *) *) *) Excluding license revenue Nestlé Infant Formula 31

32 Sales and result per year (IBT excluded) (MSEK) Total sales 400 Gross profit 300 Operating expenses (cost of goods excluded) Operating result 200 Profit before tax *) *) *) Excluding license revenue Nestlé Infant Formula 32

33 Sales per business unit (MSEK) Jan-Dec Jan-Dec Change Change % % 1) 433,0 389,6 11% 10% Adult health 85,3 74,7 14% 10% Other 16,4 19,0-14% -14% 534,7 483,2 11% 9% Pediatrics Total sales 1) Excluding currency effect 33

34 Sales per geographical market (MSEK) Jan-Dec Jan-DecChange Change MSEK % Europe 348,2 284,7 63,5 22% USA and Canada 40,2 35,2 5,0 14% Asia 62,0 52,1 9,9 19% Rest of world 84,3 111,2-26,9-24% 534,7 483,2 51,5 11% Sales per market 2016 Europe 65% (59) USA and Canada 7% (7) Asia 12% (11) Rest of world 16% (23) 34

35 Gross margin per business unit Jan-Dec Jan-Dec Pediatrics 74% 68% Adult health 62% 70% Other 98% 96% Total sales 73% 70% 35

36 Income Statements and 2015 (MSEK) Excl. currency Change effect: Total sales 534,7 483,3 11% 9% Cost of goods sold -146,9-146,7 Gross profit 387,8 336,6 15% Gross margin 73% 70% Operating expenses BioGaia -192,8-165,5 16% Participation in associated companies result -1,2-0,1 Exchange gain/loss on operation 5,6 1,8 Operating profit 199,4 172,8 15% 14% Operating margin 37% 36% Exchange gain/loss on forward exchange contracts -4,7 5,1 Interest income 1,3 0,1 Profit before tax 196,1 178,0 10% Profit margin 37% 37% Deferred tax income 10,4 - Current Tax -47,1-40,6 Profit after tax from continuing operations 159,3 137,4 16% 36

37 Balance sheet (MSEK) Dec, 31 Dec, 31 Assets Intangible assets - 16,2 Tangible assets 82,4 83,9 Shares in Associated companies 10,8 8,0 Deferred tax asset 10,4 - Current assets 142,3 138,2 Cash and cash equivalents 243,1 226,9 Total assets 489,0 473,2 Equity and liabilities Equity attributable to owners of the Parent company 415,2 395,9 Non-controlling interests - - Total equity 415,2 395,9 Deferred tax liability 0,3 0,3 Interest-free current liabilities 73,5 77,0 Total equity and liabilities 489,0 473,2 Proposed dividend: SEK 7.50 (5.00) per share 37

38 Key events 2016 Separate listing of the prior subsidiary IBT Clinical study: Meta-analysis confirms effectiveness of BioGaia ProDentis in periodontitis Clinical studies: Two meta-analyses confirm effectiveness of BioGaia ProTectis in infantile colic Clinical Study: BioGaia ProTectis effective in treating abdominal pain in children Clinical Study: BioGaia s ProDentis reduces pregnancy gingivitis Agreement for sales of BioGaia ProDentis in Hong Kong Agreement for sales of drops, tablets, and ORS in Kenya, Nigeria and Ghana Major agreement for sales of BioGaia s Probiotics in Japan Further investment in MetaboGen 38

39 Key events after the end of 2016 Agreement for the sales of BioGaia s products in Thailand 39

40 Present focus Leverage on our existing distribution network by extending our product line with current partners Increase our presence and develop our business in selected focus markets Further develop KOL and clinical study network Further develop ProDentis and Gastrus distribution network Continue the launch of EasyDropper Continue internal process development and strengthening of the organization 40

41 Board of Directors Paula Zeilon Stefan Elfving Chairman David Dangoor Inger Holmström Anthon Jahreskog Jan Annwall 41 Ewa Björling Brit Stakston

42 Major Shareholders 31 December, 2016 A shares B shares No. of votes Capital Votes % % 000's 000's SEK 000's 000's Banque Öhman S.A Swedbank Robur fonder Fjärde AP-fonden David Dangoor (inkl bolag) Mingdale Company CBNY Norges Bank Livförsäkringsaktiebolaget Skandia SSB and Trust company, Boston ,1% 40,5% % 100% 1 Annwall & Rothschild Inv. AB 10 State Street Bank & Trust com., Boston Other shareholders Total: 741 Total number of shareholders 31 December 2016: 7,740 Foreign owners: 42% of capital 42 Share capital 8,7% 34,0% 6,0% 4,3% 8,4% 5,9% 3,3% 2,7% 2,6% 2,5% 2,1% 1,9% 6,1% 4,2% 2,4% 1,9% 1,9% 1,8% 1,5% 1,4%