Investor presentation February 2018 - BioGaia

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Investor presentation February 2018 - BioGaia
Investor presentation February 2018
Investor presentation February 2018 - BioGaia
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
Investor presentation February 2018 - BioGaia
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
Investor presentation February 2018 - BioGaia
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
Investor presentation February 2018 - BioGaia
BioGaia’s partner network
                      Local distributors
                         with medical
                       representatives
                        who promote
                           to health
                        professionals

           Dietary
         supplement    BioGaia             BioGaia
                                            brand

                           Sales
                          through
                        Pharmacies

                                                     5
Investor presentation February 2018 - BioGaia
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
Investor presentation February 2018 - BioGaia
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
Investor presentation February 2018 - BioGaia
BioGaia’s Intellectual Property Rights

 •   440 issued patents in 32 families
 •   Trademarks in 66 countries + EU
 •   70 Internet-domains

                                         www.biogaia.com

                                                           8
Investor presentation February 2018 - BioGaia
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
Investor presentation February 2018 - BioGaia
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

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