investor presentation november 2017 - biogaia · investor presentation november 2017. 2 ... -...
TRANSCRIPT
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BioGaia in Short
• Founded in 1990• 118 employees• Offices in Sweden (Stockholm, Lund, Eslöv), USA, Japan• Products in 90 markets through distributors• Holds 440 patents in 32 families• Listed on the Nasdaq Stockholm (mid cap list)
The founders Peter Rothschild and Jan Annwall
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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
BioGaia – a healthcare company working with probiotics
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BioGaia’s global networkPartnersPharma andHealth Foodcompanies
SuppliersContract
Manufacturing
ResearchPre-clinical and clinical studies in hospitals and
universities
BioGaiaProduct development,
product strategies, research, Quality,
market support
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BioGaia
Local distributors with medical
representatives who promote to
health professionals
BioGaiabrand
Sales through
Pharmacies
Dietary supplement
BioGaia’s partner network
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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
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• 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
BioGaia Brand
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• 440 issued patents in 32 families • Trademarks in 66 countries + EU• 70 Internet-domains
Intellectual Property Rights
www.biogaia.com
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146 scientific articles and 12 doctoral theses
Clinical trials supporting the use of BioGaia ProbioticsLactobacillus reuteri Protectis, Prodentis and Gastrus
174 completed clinical trials in 14,700 individuals
• 122 randomised, double-blind / blind,placebo-controlled studies in 11,000 subjects
• 52 open studies in 3,700 subjects
• 59 studies in 0-3y in 7,500 subjects
Updated March 2017
Preterms Infants (0-12 mo, excl. preterms)
Children (13-36 mo) Children (4-18 y) Adults (>18 y)
174 completed clinical trials (52% children) in 14 700 individuals (71% children)
13 studies in 2534 subjects
29 studies in 2964 subjects
17 studies in 2039 subjects
31 studies in 2786 subjects
84 studies in 4265 subjects
Updated: March 201711
Clinical trials with BioGaia Probiotics in different age groups
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• 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
PROTECTIS
GASTRUS
PRODENTIS
BioGaia Probiotics and Indications
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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
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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
effectsOne 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
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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 reviewL. reuteri Protectis the only probiotic with effect in FAP
One Cochrane report supporting probiotic use in FAP
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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 childrenMeta-analysis – Significant reduction in the duration of diarrhoeaESPGHAN recommendation 2014 – L. reuteri Protectis on the positive recommendation list for
managing AGE
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Two H. pylori related clinical studies showing significant effects:– Reduced side effects and symptoms– Reduced gastritis severity and activity– Improved eradication rates
L. reuteri Gastrus in H. pylori therapy
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Clinical studies with L. reuteriProdentis on Periodontitis
Author, Year Results
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
Tekce 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 pro-inflammatory cytokine response and improvement of clinical parameters
Vicario 2012 L. reuteri supplementation in patients with initial- to-moderate chronic periodontitis resulted in significant improvements in clinical conditions compared with placebo.
Vivekananda 2010 L. reuteri Prodentis is suggested as an addition to mechanical debridement and during the maintenance phase of periodontal treatment.
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Clinical studies with L. reuteriProdentis on gingivitis and otheroralsymptoms
Author, Year Results
Schlagenhauf 2016 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.
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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
• Extended collaboration (Royalty SEK 92.0 million over three years from
q2 2014)
• Other on-going development projects
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• Production of BioGaia drops and Easy dropper
• GMP certified
• Product development
• Laboratory
BioGaia Production (former TwoPac AB, 100% owned by BioGaia)
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• Providing innovative packaging solutions allowing the development of new unique beverages
• Exclusive LifeTop™ Cap and LifeTop™ Straw supplier
(90.1% owned by BioGaia)
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.
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Our Market: Global probiotic supplement market 2015 ($ 3.8 billion)
1,9
1,2
0,6
0,1
America EU AsiaPacific Restofworld
International Probiotics Association 2015, Euromonitor International 2015
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2,6
3,8
5,4
0
1
2
3
4
5
6
2010 2015 2020
Sales($inbillion)
From 2015 to 2020, CAGR of 7,4% assumed according report from Global Market InsightInternational Probiotics Association 2013 & 2015, Global Market Insights 2016
Our Market: Global probiotic supplement sales (Sales 2015 projected to 2020)
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R&D Fermen-tation
Manu-facturing
B2B marketing
Brand owner
B2C marketing
Strong IPHigh quality & competitively priced culture
Innovative dosage formats
Consumer and HCP loyalty
Distribution channels
What defines a probiotic supplement leader?
• 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
R&D Fermen-tation
Manu-facturing B2Bmarketing Brand
owner B2Cmarketing
The BioGaia Benchmark
• 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)
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BioGaia Competitors
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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
VW Golf I and the VW Golf VI GTI, similar cars, but you do not expect the same outputTry convincing your teenage daughter that an
iPhone 3 is just as good as an iPhone 6
Different breeds have different characteristics and are suitable for different tasks
Importance of strain specificity
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Major Shareholders 30 September, 2017 (source: Euroclear)
Total number of shareholders 30 September 2017: 8,192Foreign owners: 46% of capital (33% of votes)
A shares
B shares
Share capital
No. of votes Capital Votes
000's 000'sSEK
000's 000's % %1 Annwall & Rothschild Inv. AB 741 759 1 500 8 166 8,7% 34,0%2 Swedbank Robur fonder 1 562 1 562 1 562 9,0% 6,5%3 Öhman Bank S.A 1 384 1 384 1 384 8,0% 5,8%4 Fjärde AP-fonden 1 036 1 036 1 036 6,0% 4,3%5 Clearstream Banking S.A 537 537 537 3,1% 2,2%6 Banque Pictet &CiE 496 496 496 2,9% 2,1%7 CBNY Norges Bank 451 451 451 2,6% 1,9%8 Ålandsbanken ABP, Bank of Åland LTD 420 420 420 2,4% 1,7%9 Nordea Investment Funds 409 409 409 2,4% 1,7%
10 SSB and Trust company, Boston 346 346 346 2,0% 1,4%Other shareholders 9 196 9 196 9 196 53,0% 38,3%
Total: 741 16 596 17 336 24 002 100% 100%
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MargarethaGadnell
Inger Holmström
Stefan Elving
Jan Annwall
ChairmanDavid Dangoor
Brit StakstonEwa Björling
Anthon Jahreskog
Board of Directors
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0
100
200
300
400
500
600
2012*) 2013 2014*) 2015 2016
Sales
Sales
+9 %+22 %
+25 %+11 %
*) Excluding license revenue Nestlé Infant Formula
-8%
Sales 2012-2016 (Average growth: 11%)
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0
100
200
300
400
500
600
2012*) 2013 2014*) 2015 2016
Total sales
Gross profit
Operating expenses (cost of goods excluded)Operating result
Profit before tax
Sales and result per year (IBT excluded) (MSEK)
*) Excluding license revenue Nestlé Infant Formula
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1) Excluding currency effects
Sales per segment (MSEK)
Change Change q1-q3 q1-q3 Change Change Roll 12 Roll 12 Change Changeq3 2017 q3 2016 % % 1) 2017 2016 % % 1) q3 2017 q3 2016 % % 1)
Pediatrics 111 99 12% 15% 354 314 13% 11% 473 390 21% 18%Adult health 36 23 58% 66% 85 69 23% 24% 101 89 13% 12%Other 1 4 -79% -80% 6 13 -55% -55% 9 21 -54% -59%
Total sales 148 126 17% 21% 445 396 12% 11% 584 500 17% 14%
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Gross margin per segment
q1-q3 q1-q3 Roll 12 Roll 12q3 2017 q3 2016 2017 2016 months months
Pediatrics 77% 73% 76% 72% 77% 72%
Adult health 61% 64% 66% 64% 64% 64%
Other 100% 100% 100% 100% 100% 98%
Total sales 74% 72% 75% 72% 75% 71%
4141
22%
Sales per geographical market (MSEK)
Change Jan-Sept
Jan-Sept Change 12
months12
months Change
q3 2017 q3 2016 % 2017 2016 % Sep 17 Sep 16 %
EMEA 86 87 -1% 279 284 -2% 371 356 4%
Asia Pacific 23 16 45% 60 42 43% 74 55 33%
Americas 39 23 68% 106 70 51% 139 89 56%
148 126 17% 445 396 12% 584 500 17%
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Profit & Loss (MSEK)
q1-q3 q1-q3 Roll 12 Roll 12q3 2017 q3 2016 Growth 2017 2016 Growth q3 2017 q3 2016 Growth
Sales 148 126 17% 445 396 12% 584 500 17%Gross profit 109 91 19% 332 284 17% 436 357 22%
Operating expenses -51 -46 11% -155 -136 15% -213 -176 21%Other income/expenses -4 3 -8 5 -8 4
Operating profit (EBIT) 54 48 11% 169 153 10% 215 185 16%EBIT MARGIN 36% 38% 38% 39% 37% 37% 0%
Profit after tax 42 35 20% 132 112 18% 179 138 30%EPS 2,43 2,02 20% 7,63 6,48 18% 10,34 7,93 30%
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Balance sheet (MSEK)
Sep 30 Dec 31Assets 2017 2016Tangible assets 103 82
Shares in Associated companies 10 11Deferred tax asset 10 10Current assets 160 142Cash and cash equivalents 240 243Total assets 523 489
Equity and liabilitiesEquity attributable to owners of the Parent company 418 415Non-controlling interests - -Total equity 418 415
Deferred tax liability 0 0Interest-free current liabilities 104 73Total equity and liabilities 523 489
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Cash flow (MSEK)
Jan-Sept Jan-Septq3 2017 q3 2016 2017 2016
Cash flow from operating activites beforechanges in working capital 44 36 138 114
Changes in working capital 0 17 16 -14Cash flow from operating activities 44 53 153 100Cash flow from investing activities -6 -1 -25 -4Cash flow from financing activities - - -130 -124Cash flow for the period 38 52 -2 -28
Cash at beginning of period 203 148 243 227
Cash at end of period 240 202 240 202
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• Separate listing of the prior subsidiary IBT• Further investment in MetaboGen• Launch of BioGaia Pharma
• Agreement for sales of drops, tablets, and ORS in Kenya, Nigeria and Ghana
• Major agreement for sales of BioGaia’s Probiotics in Japan• Agreement for the sales of BioGaia´s products in Thailand• Agreement for the sales of BioGaia drops in Australia• Agreement for sales of BioGaia ProDentis in Hong Kong• Agreements for sales of ProDentis in Canada, Vietnam and the
Philippines
Key events 2016 - 17
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• 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: Meta-analysis confirms effectiveness of BioGaia ProDentis in periodontitis
• Clinical Study: BioGaia’s ProDentis reduces pregnancy gingivitis
Key events 2016 - 17
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1) Excluding currency effect
Sales per segment 2016 and 2015 (MSEK)
Jan-Dec Jan-Dec Change Change
2016 2015 % % 1)
Pediatrics 433,0 389,6 11% 10%
Adult health 85,3 74,7 14% 10%Other 16,4 19,0 -14% -14%
Total sales 534,7 483,2 11% 9%
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Sales per market 2016
Europe 65% (59) USA and Canada 7% (7)
Asia 12% (11) Rest of world 16% (23)
Jan-Dec Jan-Dec Change Change 2016 2015 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 geographical market 2016 and 2015 (MSEK)
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Jan-Dec Jan-Dec
2016 2015
Pediatrics 74% 68%
Adult health 62% 70%
Other 98% 96%
Total sales 73% 70%
Gross margin per business unit 2016/2015
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Excl.currency
2016 2015 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 -0,1Exchange 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 5,1Interest 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%
Income Statements - 2016 and 2015 (MSEK)
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Balance Sheet - 2016 and 2015 (MSEK)
Dec, 31 Dec, 31
Assets 2016 2015
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