BioGaia AB May, 2016

BioGaia AB
May, 2016
1
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 aim to be the groundbreaking
leader in probiotics through:
- Innovative research
- Unique formulation and packaging
- Strong brand recognition
- Excellence in IP
- Global outreach
- Attractive workplace
- Social responsibility
2
BioGaia AB
• Founded in 1990
The founders Peter Rothschild and Jan Annwall
• 101 employees
• Offices in Stockholm, Lund, Eslöv, Raleigh, Hiroshima, Shanghai
• Contract manufacturing (TwoPac AB 100% owned)
• Listed on the OMX Nordic Exchange in Stockholm 1998
• Products in 90 markets through distributors
• Holds 440 patents in 31 families
• A leading probiotic company when it comes to clinical trials
3
Clinical trials supporting the use of
BioGaia Probiotics
Lactobacillus reuteri Protectis, Prodentis and Gastrus
155 completed clinical trials in 13 022 individuals
•
•
•
110 randomised, double-blind / blind,
placebo-controlled studies in 10 000 subjects
45 open studies in 3 000 subjects
54 studies in 0-3y in 6 800 subjects
136 scientific articles and 9 doctoral theses
Updated February, 2016
BioGaia’s global network
BioGaia
Partners
Pharma and
Health Food
companies
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
Distribution partner network
Local distributors
with medical
representatives
who promote to
health
professionals
Dietary
supplement
BioGaia
BioGaia brand
Sales through
Pharmacies
6
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
7
Bran
Brand
• Branding for Health professionals
• Sold in 55 countries
• 60% of sales 2015 of finished products
(incl. co-branding)
• Build value, less dependence
on distributors and patents
8
Clinically Proven Probiotics
9
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
10
L. reuteri Protectis in infantile colic summary
Five treatment studies showing beneficial effects (next slide)
Eight 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 pediatric consultations
– Reduction in both public and private costs for managing functional
gastrointestinal disorders
Savino et al. (2007, 2010, 2014a,b), Szajewska et al. (2012, 2014), Indrio et al. (2014), Sung (2013), Anabrees (2013),
Urbanska & Szajewska (2014)
11
Effect of L. reuteri Protectis in colic
confirmed by five studies
Change in
colicky
outcomes*
Mi
2015
Chau
2014
Savino
2007#
Szajewska
2013
Savino
2010
J Pediatr.
Pediatrics
Pediatrics
A. van
Leeuwenhoek
J Pediatr.
Reduction in crying
time by day 7
YES
YES
YES
NS
YES
Reduction in crying
time by day 21
YES
YES
YES
YES
YES
Responders by day
7
NA
NS
YES
YES
NA
Responders by day
21
YES##
YES
YES
YES
YES##
*Significant compared to placebo
#Significant compared to simethicone
##On day 28
NS: Non-significant
Responder: infant with ≥ 50% reduction in average duration of crying an fussing compared to baseline
12
NA: Not analysed
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
Bowel movements per week (mean)
L. reuteri Protectis effective in
constipated adults
p=0.023
6
5
5,3
4
3,9
Placebo (n=20)
3
2,9
L. reuteri Protectis (n=20)
2,7
2
1
0
Week 0
Week 4
L. reuteri Prodentis
15
Adjunctive treatment of periodontitis with
long-term results
47%
follow-up showed
sustained effects on
pocket depth with L.
reuteri Prodentis
compared to placebo
180
days
fewer sites in need of
surgery with L. reuteri
Prodentis compared to
placebo
mm
6
4
2
0
0
Teughels 2013, J Clin Perio
30
60
90
Days
120
150
180
Tekçe M, et al.2015. J Clin Perio.
Ince G et al. 2015. J Perio.
Prevention?
17
Gutierrez - Diarrhea in Preschool Children and L. reuteri Protectis
L. reuteri Protectis (n=168)
Placebo (n=168)
18
Study outcomes confirm previous results
Reduced number of
days:
•
with diarrhoea
•
with antibiotic use
•
with fever
•
absent from day
care
•
with respiratory
tract infection
Gutierrez, 2014
(n=336)
Weizman, 2005
(n=128)
Agustina, 2012
(n=250)
NA
NA
NS
NS
19
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)
20
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
21
Indrio 2014.
BioGaia current products
ProTectis
ProDentis
Gastrus
Digestive Health
Oral Health
Stomach Health
ProTectis
ProTectis D3
ProTectis
ProTectis
Baby
Baby
Junior
Baby/Junior
Drops
Drops
Tablets
ORS
ProTectis
Tablets
ProDentis
Drops
ProDentis
Gastrus
Lozenges
Tablets
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Attractive and unique formulations
and packaging solutions
23
Cooperation with Nestlé
•
Agreement 2008 (Infant formula)
•
New licence agreement infant formula 2012 (EUR 50.8
million)
•
Drops in U.S and UK
•
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 ongoing development projects
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(90.1% owned by BioGaia)
• Providing innovative packaging solutions
allowing the development of new unique
beverages
• Exclusive LifeTop™ Cap and LifeTop™
Straw supplier
MetaboGen (27% 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.
TwoPac AB (100% owned by BioGaia)
The Market
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Probiotic supplements global market
Probiotic supplements – historic global sales and
projections (in billions $)
5,0
4,3
4,5
4,0
3,5
2,8
3,0
2,5
Probiotic supplements global sales
1,8
2,0
1,5
1,0
0,5
0,0
2007
2012
2017
29
Euromonitor International 2013
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
30
Five years development and 2015
31
Sales development – 5 years
Average growth: 15%
Sales
600
+25%
500
+22%
400
+33%
300
-8%
+9%
Sales
200
100
0
2011
2012*)
2013
2014*)
2015
*) Excluding licence revenue from Nestlé of 356 MSEK / 95,4 MSEK
32
Sales and result per year (MSEK) (excl licence revenue from
Nestlé 2012 and 2014)
600
500
Total sales
400
Gross profit
300
Operating expenses (cost of
goods excluded)
Operating result
200
Profit before tax
100
0
2011
2012*)
2013
2014*)
2015
*) Excluding licence revenue from Nestlé
33
Sales per business unit
Pediatrics
Adult health
Other
2015
389,6
74,7
19,0
Total sales
483,2
Change Change
20142)
%
% 1)
301,2
29%
19%
69,4
8%
2%
15,7
21%
21%
386,4
25%
16%
1) Excluding currency effects
2) Excluding licence revenue of SEK 95.4 million
34
Sales per geographical market (MSEK)
(excl. Licence revenue)
Europe
USA and Canada
Asia
Rest of world
2015
284,8
35,2
52,1
111,1
2014 Change
257,8
27,0
30,3
4,9
38,8
13,3
59,5
51,6
483,2
386,4
96,8
Change
%
10%
16%
34%
87%
25%
Europe 59% (67)
USA and Canada 7% (8)
Asia 11% (10)
Rest of world 23% (15)
35
Income statement 2015/2014
Excl. Licrevenue
2014 Change
301,2
29%
69,4
8%
15,7
20%
386,4
25%
-131,3
2015
389,6
74,7
19,0
483,2
-146,7
2014
301,2
69,4
15,7
95,4
481,7
-131,3
336,6
70%
350,4
73%
255,0
66%
32%
-165,4
-20,6
-0,1
1,7
-154,6
-6,6
7,7
-154,6
-6,6
7,7
7%
152,2
31%
36%
196,9
51%
42%
101,5
26%
28%
50%
5,1
0,1
-6,6
2,2
-6,6
2,2
Profit before tax
Profit margin
157,4
33%
192,5
40%
97,1
25%
Tax
-36,1
-44,5
-23,5
Profit after tax
121,3
148,0
73,6
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
Participattion in assosciated companie´s result
Exchange gain/loss on operation
Operating profit
Operating margin
Operating margin excl IBT
Exchange gain/loss on forward exchange
contracts
Interest income
62%
65%
36
Excl
currency
effect:
19%
2%
20%
16%
34%
Quarter 1 2016
37
Sales during the quarter and rolling 12 months
per business unit
Pediatrics
Adult health
Other
Total sales
q1 2016
108,1
21,1
4,7
q1 2015
115,2
19,8
3,8
133,9
138,8
Change Change
%
% 1)
-6%
-6%
7%
7%
24%
24%
-4%
-4%
Apr 15Mar 16
382,3
76,0
19,9
478,2
Apr 14- Change Change
Mar 15
%
% 1)
339,8
13%
6%
74,2
2%
-1%
18,0
11%
11%
432,0
1) Excluding currency effects
38
11%
5%
Sales per segment (business unit) rolling 12 months
(MSEK) (excl license revenue 2014)
450,0
400,0
350,0
300,0
250,0
Pediatrics
200,0
Adult
150,0
100,0
50,0
0,0
q4 2013 q1 2014 q2 2014 q3 2014 q4 2014 q1 2015 q2 2015 q3 2015 q4 2015 q1 2016
39
Gross margin per business unit and product area,
during the quarter and rolling 12 months
Pediatrics
Adult health
Other
Total sales
q1 2016
71%
64%
94%
q1 2015
69%
71%
96%
71%
70%
Apr 15- Apr 14Mar 16 Mar 15
69%
66%
68%
67%
96%
96%
70%
67%
40
Sales per geographical market (MSEK)
Europe
USA and Canada
Asia
Rest of world
q1 2016
93,3
9,9
13,5
17,2
q1 2015
92,0
6,1
13,6
27,1
Change
1,3
3,8
-0,1
-9,9
Change
%
1%
62%
-1%
-37%
133,9
138,8
-4,9
-4%
12 mån
Mar 16
286,0
39,0
52,0
101,2
478,3
12 mån
Mar 15 Change
279,0
7,0
33,6
5,4
41,9
10,1
77,5
23,7
432,0
46,2
Europe 60% (65)
USA and Canada
8% (8)
Asia 11% (10)
Rest of world 21%
(18)
41
Change
%
3%
16%
24%
31%
11%
Income Statement quarter 1
Total sales
Cost of goods sold
Gross profit
Gross margin
Operating expenses BioGaia
Operating expenses IBT
Participation in associated companie´s result
Exchange gain/loss on operation
Operating profit
Operating margin
Operating margin excl IBT
Exchange gain/loss on forward exchange contracts
Interest income
q1 2016
q1 2015
Change
Excl.
currency
effect:
133,9
138,8
-4%
-4%
-39,1
-41,0
94,8
97,8
71%
70%
-42,3
-44,9
-5,2
-3,6
-0,2
-
-1,0
3,3
46,1
52,6
34%
38%
38%
41%
-0,5
3,2
0,0
0,1
Profit before tax
Profit margin
45,6
55,9
34%
40%
Tax
-12,0
-12,6
33,6
43,2
Profit after tax
-3%
-6%
-12%
-12%
-19%
-22%
42
Income statement rolling 12 months
Excl
currency
Change
effect:
11%
5%
q1 2016
478,2
-144,7
q1 2015
432,0
-140,6
333,5
70%
291,4
67%
14%
-162,9
-22,1
-0,3
-2,5
-166,9
-8,8
10,0
-2%
145,7
30%
35%
125,7
29%
31%
16%
1,4
-0,1
-3,5
1,6
Profit margin
147,0
31%
123,8
29%
Tax
-35,4
-29,5
Profit after tax
111,6
94,3
Total sales
Cost of goods sold
Gross profit
Gross margin
Operating expenses BioGaia
Operating expenses IBT
Participation in associated companie´s result
Exchange gain/loss on operation
Operating profit
Operating margin
Operating margin excl IBT
Exchange gain/loss on forward exchange
contracts
Interest income
Profit before tax
19%
18%
43
2%
Balance sheet (MSEK)
March 31
2016
83,7
7,7
138,9
221,5
451,8
Dec, 31
2015
16,2
83,9
8,0
138,2
226,9
473,2
Equity and liabilities
Equity attributable to owners of the Parent
company
Non-controlling interets
Total equity
380,0
380,0
395,9
395,9
Deferred tax liability
Other provisions
Interest-free current liabilities
Total equity and liabilities
0,3
71,5
451,8
0,3
77,0
473,2
Assets
Intangible assets
Tangible assets
Shares in Associated companies
Current assets
Cash and cash equivalents
Total assets
Proposed dividend: SEK 5.00 per share
44
Cash flow (MSEK)
Operating activities
Operating profit
Depreciation
Other non-cash items
Taxes paid
Realised forward exchange contracts
Interest received and paid
Cash flow from operating activites before
changes in working capital
Changes in working capital
Cashflow from operating activities
Cashflow from investing activities
Cashflow from financing activities
Cash flow for the period
Cash at beginning of year
Exchange difference in cash
Cash at end of year
q1 2016
q1 2015
46,1
1,7
0,6
-12,3
-0,3
0,0
52,6
1,3
-1,2
-14,5
0,4
0,1
35,8
-1,5
34,3
-1,5
-37,6
-4,8
38,7
4,7
43,4
-5,6
37,8
226,9
-0,6
221,5
210,7
1,5
250,0
45
Key events first quarter 2016
Separate listing of IBT
New meta-analysis confirms effectiveness of
BioGaia ProTectis for infant colic
Meta-analysis confirms effectiveness of BioGaia ProDentis in
periodontitis
Key events after first quarter 2016
Agreement with BioWellTech for the sales of BioGaia ProDentis in
Hong Kong
Another meta-analysis confirms effectiveness of BioGaia ProTectis
in infantile colic
BioGaia guarantees rights issue in IBT
46
Board of Directors 2015
Paula Zeilon
Stefan Elfving
Chairman
David Dangoor
Ingrid Holmström
Anthon Jahreskog
Jan Annwall
Ewa Björling
Brit Stakston
47
Major Shareholders 31 March, 2016
A
B
shares shares
Annwall & Rothschild Inv. AB
Banque Öhman
Fjärde AP-fonden
Handelsbankens Fonder AB
David Dangoor (inkl bolag)
Livförsäkringsaktiebolaget Skandia
CBNY Norges Bank
Mingdale Company
State Street Bank & Trust com., Boston
Swedbank Robur fonder
Other shareholders
Total:
Share
capital
No. of
votes Capital
Votes
000's
741
000's
759
1 111
1 018
586
569
526
520
462
436
395
10 214
000's
1 500
1 111
1 018
586
569
526
520
462
437
395
10 214
000's
8 166
1 111
1 018
586
569
526
520
462
436
395
10 214
%
8,7%
6,4%
5,9%
3,4%
3,3%
3,0%
3,0%
2,7%
2,5%
2,3%
58,9%
%
34,0%
4,6%
4,2%
2,4%
2,4%
2,2%
2,2%
1,9%
1,8%
1,6%
42,6%
741
16 596
17 336
24 002
100%
100%
Total number of shareholders 31 March 2016: 7,625
Foreign owners: 46,9% of capital (33,9% of votes)
48
Present focus
• Japan, US, UK, China and India
• Extend product line with partners
• ProDentis and Gastrus roll-out
• Launch of Easy Dropper
• Review of activities, priorities and strategy
while driving current business
49