Investor presentation February 2018 - BioGaia
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BioGaia in short • Founded in 1990 • 124 employees • Offices in Sweden (Stockholm, The founders Peter Rothschild and Jan Annwall Lund, Eslöv), USA, Japan • Products in 100 markets through distributors • Holds 440 patents in 32 families • Listed on the Nasdaq Stockholm (mid cap list) 2
BioGaia – a healthcare company working with probiotics Mission: BioGaia conducts research and development to provide consumers with clinically proven, health-promoting, patented and user-friendly probiotic products. Vision: To be a 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
BioGaia Partners Product development, Suppliers BioGaia’s global network Pharma and product strategies, research, Quality, Contract Health Food Manufacturing market support companies Research Pre-clinical and clinical studies in hospitals and universities 4
BioGaia’s partner network Local distributors with medical representatives who promote to health professionals Dietary supplement BioGaia BioGaia brand Sales through Pharmacies 5
BioGaia’s partner support • Clinical trials • Marketing and PR support • BioGaia Academy • Workshops • Participation in medical congresses • Speakers at symposiums • Education of sales representatives • www.biogaia.com • Social media • Customer support 24/7/365 6
BioGaia Brand • Branding for Health professionals • Sold in 60 countries • 69% 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 2017. • Build value, less dependence on patents Protectis Protectis Gastrus Prodentis 7
BioGaia’s Intellectual Property Rights • 440 issued patents in 32 families • Trademarks in 66 countries + EU • 70 Internet-domains www.biogaia.com 8
Clinical trials supporting the use of BioGaia Probiotics 184 completed clinical trials in 15,500 individuals 159 scientific articles and 12 doctoral theses Updated March 2017 9
Clinical trials with L. reuteri Protectis in different age groups 137 completed clinical trials (66% children) in 12,829 individuals (82% children) 46 studies in 2 301 subjects 26 studies in 2 559 subjects 17 studies in 2 039 subjects 32 studies in 3 109 subjects 16 studies in 2 821 subjects Preterms Infants (0-12 mo, Children (13-36 mo) Children (4-18 y) Adults (>18 y) excl. preterms) CONFIDENTIAL 10 Updated: March 2017
BioGaia Probiotics and Indications Colic Functional gastrointestinal disorders Regurgitation Protectis Acute gastroenteritis Constipation Protectis Functional abdominal Support of gastrointestinal pain health Antibiotic-associated side- effects Eradication treatment associated side-effects Gastrus HP-infection Gingivitis Prodentis Periodontitis 11
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 12
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 13
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 14
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 15
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 16
Clinical studies with L. reuteri Prodentis on Periodontitis Author, Year Results In patients with deep pockets supplementation of Lactobacillus reuteri Prodentis as an adjunct Teughels 2013 to SRP leads to significant reduction in the need for surgery In patients with deep pockets supplementation of Lactobacillus reuteri Prodentis as an adjunct Tekçe 2015 to SRP leads to additional PD reduction of 1 mm at 1-year follow-up Adjuvant probiotic therapy provides additional benefit over initial periodontal therapy on clinical Ince 2015 and biochemical parameters over 180 days. L. reuteri induces in most of the patients with chronic periodontitis a significant reduction in pro- Szkaradkiewicz 2013 inflammatory cytokine response and improvement of clinical parameters L. reuteri supplementation in patients with initial- to-moderate chronic periodontitis resulted in Vicario 2012 significant improvements in clinical conditions compared with placebo. L. reuteri Prodentis is suggested as an addition to mechanical debridement and during the Vivekananda 2010 maintenance phase of periodontal treatment. 17
Clinical studies with L. reuteri Prodentis on gingivitis and otheroral symptoms Author, Year Results Supplementation of L. reuteri Prodentis significantly reduced inflammation and plaque Schlagenhauf 2016 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. Daily supplementation with L. reuteri from birth and during the first year of life is associated with Stensson 2013 reduced caries prevalence and gingivitis score in the primary dentition at 9 years of age. L. reuteri Prodentis delays regrowth of caries-associated Streptococcus mutans after full-mouth Romani 2015 disinfection. Daily use of L. reuteri Prodentis showed beneficial effect on oral malodour assessed by Keller 2012 organoleptic scores. The probiotic lozenge containing L. reuteri Prodentis significantly reduced salivary Çaglar 2008 Streptococcus mutans streptococci. 18
BioGaia Group 19
BioGaia Group The microbiome partner Antibiotic resistance Foundation BioGaia AB 36% MetaboGen Capable Pharma Production 20
BioGaia Group The microbiome partner Antibiotic resistance BioGaia AB 36% Foundation Metabogen Capable Pharma Production • Production of BioGaia drops, Easy Dropper, MiniPac and samples • GMP pharma certified • Product development • Laboratory GMP certified BioGaia Production BioGaia Production 21
BioGaia Group The microbiome partner Antibiotic resistance BioGaia AB 36% Foundation Metabogen Capable Pharma Production • BioGaia Pharma AB is a subsidiary to BioGaia AB applying 25 years of probiotic experience to the research and development of new microbial therapeutic platforms. • Through an established network of research institutions and companies, BioGaia Pharma’s mission is to match early research on candidates from the microbiome with unmet medical needs to develop drug platforms. • Formed: June 2017 • Location: Stockholm, Sweden • www.biogaiapharma.com • Areas of focus: infectious diseases; inflammatory and gastrointestinal disorders
BioGaia Group The microbiome partner Antibiotic resistance BioGaia AB 36% Foundation Metabogen Capable Pharma Production • Providing innovative packaging solutions allowing the development of new unique beverages • Exclusive LifeTop™ Cap and LifeTop™ Straw supplier • Learn more at www.lifetop.eu LifeTop™ Cap LifeTop™ Straw
BioGaia Group The microbiome partner Antibiotic resistance BioGaia AB 36% Foundation Metabogen (36% owned by BioGaia) Capable Pharma Production Development of next generation probiotics • MetaboGen works to develop products from novel bacterial strains, targeted for precise indications and derived from the human gut microbiome • Products may be food supplements, or drugs, depending on the indication and the preference of future partners • MetaboGen provides BioGaia with access to front-line development of next generation microbial products, including regulatory development in this emerging field DISCOVERY, FINDING FULL METAGENOME STRAIN PRODUCT CLINICAL TRIAL FUNCTIONAL RELATIONSHIPS ANALYSIS IDENTIFICATION DEVELOPMENT REGULATORY WORK MARKETING Jens Nielsen Systems Biology R&D Fredrik Bäckhed Metabolic disease R&D Performed in MetaboGen, including unique technology for producing products of anaerobic strains Together with partners
BioGaia Group A BioGaia The microbiome partner Antibiotic Foundation against resistance BioGaia AB 36% Foundation Metabogen Antibiotic Resistance Capable Pharma Production A BioGaia CSR initiative that supports research and education within the area of antibiotic resistance by: Giving financial support to research and education that helps to prevent infections which reduces the use of antibiotics and the risk of antibiotic resistance. Activities • Twitter account (@ResResistance) • Monthly newsletter – Resist the resistance • Meetings with companies, organizations, politicians to influence decision makers • Articles in regional newspapers and appearances by BioGaia representatives in media 25
Nestlé cooperation 26
Cooperation with Nestlé • Agreement Infant formula 2008 • New licence agreement infant formula 2012 (EUR 50.8 million, recognised in 2012 and 2014) • Sales of drops in the US and Australia • Royalty agreement for the sales of Growing Up Milk for children above the age of one • Collaboration agreement (Royalties of total 92 MSEK over 2014- 2018) • Other on-going development projects 27
Market and Competitors 28
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 2015 29
Our Market: Global probiotic supplement sales (Sales 2015 projected to 2020) 6 5,4 5 4 3,8 3 2,6 2 1 0 2010 2015 2020 Sales ($ in billion) From 2015 to 2020, CAGR of 7,4% assumed according report from Global Market Insight International Probiotics Association 2013 & 2015, Global Market Insights 2016 30
What defines a probiotic supplement leader? High quality & Innovative Consumer Distribution Strong IP competitively dosage and HCP channels priced culture formats loyalty Fermen- Manu- B2B Brand B2C R&D tation facturing marketing owner marketing 31
The BioGaia Benchmark Fermen- Manu- Brand R&D B2B marketing B2C marketing tation facturing owner • BioGaia IP, R&D and Product Development have enabled development of the BioGaia pediatric brand with unrivaled global distribution channels • BioGaia does not have in-house fermentation manufacturing capabilities • BioGaia has focused less on B2C marketing
BioGaia Competitors • Companies developing, producing, and selling probiotics (Chr. Hansen) • Well studied probiotic strains (L.GG from Valio) • Non probiotic products / drugs (Imodium, Simethicone) • Probiotic products with strong brands (Enterogermina) • Pharma companies (Sanofi) • Functional Food (ProViva) 33
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 6 34
Major shareholder and Board of Directors 35
Major Shareholders 31 December, 2017 (source: Euroclear) Share No. of A shares B shares capital votes Capital Votes 000's 000's SEK 000's 000's % % 1 Annwall & Rothschild Inv. AB 741 509 1 250 7 916 7,2% 33,0% 2 Swedbank Robur fonder 1 626 1 626 1 626 9,4% 6,8% 3 Öhman Bank S.A 1 354 1 354 1 354 7,8% 5,6% 4 Fjärde AP-fonden 1 243 1 243 1 243 7,2% 5,2% 5 Clearstream Banking S.A 538 538 538 3,1% 2,2% 6 Banque Pictet &CiE 478 478 478 2,8% 2,0% 7 CBNY Norges Bank 456 456 456 2,6% 1,9% 8 Ålandsbanken ABP, Bank of Åland LTD 421 421 421 2,4% 1,8% 9 SSB and Trust company, Boston 346 346 346 2,0% 1,4% 10 Tredje AP-fonden 316 316 316 1,8% 1,3% Other shareholders 9 309 9 309 9 309 53,7% 38,8% Total: 741 16 596 17 336 24 002 100% 100% Total number of shareholders 31 December 2017: 8,566 Foreign owners: 46% of capital (33% of votes) 36
Board of Directors Chairman Stefan Elving David Dangoor Inger Holmström Jan Annwall Anthon Jahreskog Margaretha Gadnell Ewa Björling Brit Stakston 37
Sales and Profit 5 years Development 38
Sales – 5 years development Sales 700 +15% 600 +11% 500 +25% 22% 400 9% Sales 300 Average growth: 16% 200 100 0 2013 2014*) 2015 2016 2017 39
Sales and result per year (IBT excluded) (MSEK) 700 600 Total sales 500 Gross profit 400 Operating expenses (cost 300 of goods excluded) Operating result 200 Profit before tax 100 0 2013 2014*) 2015 2016 2017 *) Excluding license revenue Nestlé Infant Formula 40
2017 and q4 41
Sales per segment (MSEK) Q4 Q4 Change Change Jan-Dec Jan-Dec Change Change 2017 2016 % % 1) 2017 2016 % % 1) Pediatrics 139 119 16% 20% 493 433 14% 13% Adult health 31 16 95% 104% 116 85 36% 39% Other 1 4 -85% -85% 6 16 -62% -62% Total sales 170 139 23% 27% 615 535 15% 15% 1) Excluding currency effects 42
Sales per geographical market (MSEK) Q4 Q4 Change Jan-Dec Jan-Dec Change 2017 2016 % 2017 2016 % EMEA 115 22% 93 24% 393 376 5% Asia Pacific 35 13 161% 95 56 72% Americas 20 32 -38% 126 103 23% 170 139 23% 615 535 15% 43 43
Current Regional sales split Europe, Middle East & Africa Americas 64% Asia Pacific 20% 16% 44
Gross margin per segment Q4 Q4 Jan-Dec Jan-Dec 2017 2016 2017 2016 Pediatrics 78% 77% 77% 74% Adult health 71% 54% 67% 62% Other 93% 99% 99% 98% Total sales 77% 75% 75% 73% 45
Profit & Loss (MSEK) Jan-Dec Jan-Dec q4 2017 q4 2016 Growth 2017 2016 Growth Sales 170 139 23% 615 535 15% Gross profit 131 104 26% 463 388 19% Operating expenses -69 -57 21% -225 -193 17% Other income/expenses 3 -1 -5 4 Operating profit (EBIT) 65 46 40% 234 199 17% EBIT MARGIN 38% 33% 38% 37% Profit after tax 48 47 3% 180 159 13% EPS 2,79 2,71 3% 10,42 9,19 13% 46
Balance sheet (MSEK) Dec 31 Dec 31 Assets 2017 2016 Property, plant & Equipment 103 82 Shares in Associated company 10 11 Deferred tax asset 9 10 Current assets 148 142 Cash and cash equivalents 306 243 Total assets 576 489 Equity and liabilities Equity attributable to owners of the Parent company 464 415 Non-controlling interests - - Total equity 464 415 Deferred tax liability 1 - Interest-free current liabilities 111 73 Total equity and liabilities 576 489 Proposed dividend: 9.00 SEK per share (total 156 MSEK) and 2.7 MSEK to Foundation 47
Cash flow (MSEK) Q4 Q4 Jan-Dec Jan-Dec 2017 2016 2017 2016 Cash flow from operating activities 53 41 191 155 before changes in working capital Changes in working capital 16 6 32 -7 Cash flow from operating activities 69 48 223 148 Cash flow from investing activities -2 -6 -27 -10 Cash flow from financing activities -2 - -132 -124 Cash flow for the period 66 42 64 14 Cash at beginning of period 240 202 243 227 Cash at end of period 306 243 306 243 48
Key events 2017 • Start of BioGaia Pharma, a new subsidiary for the development of probiotic drugs • Agreement for the sales of BioGaia´s products in Thailand • Agreement for the sales of BioGaia Protectis drops in Australia • Agreements for sales of BioGaia ProDentis lozenges in Canada, South Korea, Vietnam and the Philippines • Launches of BioGaia BioGaia Protectis drops in Australia, Kenia, Philippines and Kosovo • Launches of BioGaia Protectis tablets in Colombia, Finland (new flavour), Germany, Honduras, Mexico and Thailand • Launches of BioGaia Prodentis lozenges in Philippines and Vietnam • Launch of Yoghurt with BioGaia Prodentis bacteria culture in Japan • Launch of BioGaia Protectis tablets with 20 microgram of Vitamin D in Italy and Canada • Launch of BioGaia Gastrus tablets in Hong Kong • Launch of LifeTop Straw in Singapore 49
Key events 2017 (cont’d) • Clinical study published: BioGaia Protectis shown to promote growth and prevent recurrent diarrhea. • Clinical Study: Lactobacillus reuteri reduced bone loss in older women. Key events after the end of 2017 • Two new meta-analyses confirm the effectiveness of BioGaia’s probiotic in infant colic. • BioGaia Protectis with vitamin D to be launched on the Swedish market. • Agreement with Abbott for the rights to sell BioGaia Protectis tablets in China. 50
Present Focus – BioGaia Strategic Drivers Growth Customer focus Operational Efficiency Innovation Sustainability My personal We are business-minded We are honest, engagement is a prerequisite We are innovative and and deliver on our respectful, and selfless in for BioGaia’s success action-oriented promises what we do and say 51
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