BioGaia presentation March 2015

BioGaia presentation
March 2015
1
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
BioGaia AB
•  Founded in 1990
The founders Peter Rothschild och Jan Annwall
•  100 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
3
Change of focus
Oral Health
Dietary Supplements
Infant formula
Functional Foods / Dairies
Animal Health
1990
1995
2000
2005
2010
2015
4
BioGaia’s global network
Partners
Pharma and
Health Food
companies
BioGaia
Product development,
product strategies,
research, Quality,
market support
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
Suppliers
Contract
Manufacturing
Business model – three networks
Distribution partners
Sales force
Research
Pharmacies
Clinical
Physicians
Preclinical
Innovation & IPR
Product
strategies
Quality systems
Marketing support
Product
development
Indications
Research
Production
Food
supplements
Probiotic
cultures
6
Distribution partner network
Local distributors
with medical
representatives
who promote to
health
professionals
Dietary
supplement
BioGaia
BioGaia brand
Sales through
Pharmacies
7
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
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
Clinical trials supporting the use of
BioGaia Probiotics
Lactobacillus reuteri Protectis, Prodentis and Gastrus
137 completed clinical trials in 11 700 individuals
• 
• 
• 
97 randomised, double-blind / blind,
placebo-controlled studies in 8 800 subjects
41 open studies in 2 900 subjects
45 studies in 0-3y in 6 100 subjects
108 scientific articles and 9 doctoral theses
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
Colic studies with L. reuteri Protectis
Szajewska 2013
250
Placebo (n=40)
L. reuteri Protectis (n=40)
p=0.8
200
Ø  Szajewska: 69% reduction with L. reuteri
Protectis compared to 47% with placebo
p=0.002**
p<0.0001
150
Ø  Savino: 90% reduction with L. reuteri
Protectis compared to 70% with placebo
p<0.0001
100
p<0.0001
Ø  Savino: 62% reduction with L. reuteri
Protectis compared to 22% with simethicone
50
0
Reduction in median crying time after 21 days
0
7
14
21
28*
Savino 2010
400
Savino 2007
Placebo (n=21)
L. reuteri Protectis (n=25)
p=0.127
350
300
Simethicone (n=42)
L. reuteri Protectis (n=41)
p=0.005
150
250
p<0.001
200
p<0.001
100
150
p<0.001
p=0.082
p=0.099
100
p=0.022
50
0
p=0.987
200
0
7
14
21
50
0
0
7
14
21
12
* Follow-up 1 week after termination of intervention
28
84% 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
Cimperman et al, 2011
Prevention?
14
Gutierrez - Diarrhea in Preschool Children and L. reuteri Protectis
L. reuteri Protectis (n=168)
Placebo (n=168)
15
Study outcomes confirm previous results
Reduced number of
days:
Gutierrez, 2014
(n=336)
Weizman, 2005
(n=128)
✔
✔
✔
✔
✔
✔
✔
✔
NA
•  absent from day
care
✔
✔
NA
•  with respiratory
tract infection
✔
NS
NS
•  with diarrhoea
•  with antibiotic use
•  with fever
Agustina, 2012
(n=250)
16
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
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
18
Indrio 2014.
Attractive and unique formulations and
packaging solutions
19
BioGaia partner support
• 
• 
• 
• 
• 
• 
• 
• 
• 
• 
Clinical trials
Marketing and PR support
BioGaia Academy
Workshops
www.biogaia.com
Participation in medical congresses
Speakers at symposiums
Education of sales representatives
Social media
Customer support 24/7/365
21
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
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
Sales development – 5 years
Average growth: 14%
Sales
450.0
+22%
400.0
350.0
+33%
300.0
250.0
+9%
-8%
+16%
Sales
200.0
150.0
100.0
50.0
0.0
2010
2011
20121)
2013
20141)
1) Excluding licence revenue from Nestlé of 356 MSEK / 95,4 MSEK
24
Sales per geographical market 2014
Europe 67% (69)
USA and Canada 8% (7)
Asia 10% (13)
Rest of world 15% (11)
25
Income statement 2014/2013
2014
313,7
69,5
3,2
95,4
481,8
-131,3
Excluding
Licence rev.
2014
313,7
69,5
3,2
386,4
-131,3
2013
238,6
75,6
1,7
315,9
-101,7
350,5
73%
255,1
66%
214,2
68%
19%
-154,7
-6,6
7,7
-154,7
-6,6
7,7
-134,3
1,8
15%
196,9
41%
42%
101,5
26%
28%
81,7
26%
26%
24%
-6,6
2,2
-6,6
2,2
-2,9
5,0
Profit before tax
Profit margin
192,5
40%
97,1
25%
83,8
27%
Tax
-44,5
-23,5
-19,6
Profit after tax
148,0
73,6
64,2
Net sales Paediatrics
Net sales Adult Health
Net sales other
Licence revenue
Total sales
Cost of goods sold
Gross profit
Gross margin
Operating expenses BioGaia
Operating expenses IBT
Exchange gain/loss on operation
Operating profit
Operating margin
Operating margin excl IBT
Exchange gain/loss on forward exchange contracts
Interest income
1) 21 % excluding IBT expenses and currency effects
Excl
currency
effect:
31%
27%
-8%
-12%
22%
16%
15%
26
18%
13% 1)
Balance sheets (MSEK)
Dec, 31
Dec 31,
2014
2013
6,1
-
72,8
60,3
4,0
-
Current assets
122,0
88,8
Cash and cash equivalents
210,7
234,3
Total assets
415,6
383,4
344,5
317,3
0,1
-0,5
344,6
316,8
Deferred tax liability
0,2
0,1
Other provisions
3,9
-
66,9
66,5
415,6
383,4
Assets
Intangible assets
Tangible assets
Other financial assets
Equity and liabilities
Equity attributable to owners of the Parent company
Non-controlling interets
Total equity
Interest-free current liabilities
Total equity and liabilities
Proposed dividend: SEK 5.00 per share
27
5 years development (2012 and 2014: excluding licence revenue from Nestlé)
450
400
350
Total sales
300
Gross profit
250
Operating expenses (cost of goods
excluded)
200
Operating result
150
Profit before tax
100
50
0
2010
2011
2012*)
2013
2014*)
28
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
Board of Directors 2014
Paula
Zeilon
Stefan
Elfving
Jan Annwall
Chairman
David
Dangoor
Jan Litborn
Ingrid
Holmström
Jörgen
Thorball
Brit Stakston 30
Major Shareholders 31 December, 2014
1
2
3
4
5
6
7
8
9
10
A
B Share
shares shares capital
SEK
000's
000's
000's
Annwall & Rothschild Inv. AB
741
759
1 500
Sebastian Jahreskog
1 263
1 263
Fjärde AP-fonden
693
693
JPM Chase NA
689
689
David Dangoor (inkl bolag)
569
569
Nordea Investment Funds
550
550
Handelsbanken Fonder AB
533
533
Banque Pictet & CIE, W8IMY
509
509
Six Sis AG W8IMY
426
426
State Street Bank & Trust com., Boston
415
415
Other shareholders
10 124 10 124
No. of
votes Capital
Votes
000's
8 166
1 263
693
689
569
550
533
509
426
415
10 124
%
8,7%
7,3%
4,0%
4,0%
3,3%
3,2%
3,1%
2,9%
2,5%
2,4%
58,6%
%
34,1%
5,3%
2,9%
2,9%
2,4%
2,3%
2,2%
2,1%
1,8%
1,7%
42,3%
Total:
23 937
100%
100%
741
16 530
17 271
Total number of shareholders 31 December, 2014: 7,136
Foreign owners: 47% of capital (34% of votes)
31
Probiotic supplements global market
Probiotic supplements – historic global sales and
projections (in billions $)
5.0
4.3
4.5
4.0
3.5
3.0
2.8
2.5
2.0
Probiotic supplements global sales
1.8
1.5
1.0
0.5
0.0
2007
Euromonitor International 2013
2012
2017
32
Launches
-  Drops: Launched in 71 countries
-  Tablets: Launched in 57 countries
-  ORS: Launched in 14 countries
-  Oral health products: Launched in 22
countries
33
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
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