Biotest AG · Biotest Group: H1 2019 at a glance • Guidance 2019 confirmed • Sales of...
Transcript of Biotest AG · Biotest Group: H1 2019 at a glance • Guidance 2019 confirmed • Sales of...
Biotest AGCompany Presentation
September 2019
Disclaimer
• This document contains forward-looking statements on overall economic
development as well as on the business, earnings, financial and asset situation of
Biotest AG and its subsidiaries. These statements are based on current plans,
estimates, forecasts and expectations of the company and thus are subject to risks
and elements of uncertainty that could result in deviation of actual developments
from expected developments.
• The forward-looking statements are only valid at the time of publication. Biotest does
not intend to update the forward-looking statements and assumes no obligation to
do so.
• All figures reported relate to the Continuing Operations of the Biotest Group, if not
specified otherwise. After the transfer of all US subsidiaries incl. our associate ADMA
Biologics Inc., these activities are being reported as Discontinued Operations in the
previous year.
• All comparative figures relate to the corresponding last year´s period, unless stated
otherwise.
2Company Presentation Biotest AG
Biotest Group: H1 2019 at a glance
• Guidance 2019 confirmed
• Sales of Continuing Operations in H1 2019
at €195.1 m vs. €200.7 m in H1 2018
• EBIT in H1 2019 at €-5.5 m vs.
€0.6 m in H1 2018
• Opening of two new plasma collection centres
in Germany and Hungary; Total number to
date 21
• Approved indications of Intratect® in 22
European countries to include CIDP*, MMN**,
as well as an extension in the area of
secondary immunodeficiencies
• Biotest Next Level project progressing
3Company Presentation Biotest AG
*: Chronic Inflammatory Demyelinating Polyneuropathy; **: Multifocal Motor Neuropathy
CREAT Integration/ Financing of Biotest
• Takeover became effective January 30, 2018
• CREAT gave Shareholder Loan to Biotest for re-financing (€ 290 million)
• Tiancheng International (holding company for Biotest and BPL) to be contributed/
integrated into Shanghai RAAS
But: this was postponed till contribution of 45% of Grifols Diagnostic Services
(“GDS”) to Shanghai RAAS by Grifols S.A. will be effective
• 5 year financing agreement for a volume of €240 million completed in June 2019
Company Presentation Biotest AG 4
CREAT – Shanghai RAAS – Grifols - GDS
Ownership after the on-going deal between Shanghai RAAS and Grifols
Current ownership%
(%)
Grifols to take 26% stake in Shanghai RAAS in exchange for 45% in GDS (40% voting rights)
− Grifols has received US anti-trust approval (15 May 2019)
Strategic plan for a multi-step consolidation of CREAT’s existing plasma investments in Shanghai RAAS and Biotest
Grifols
Diagnostics Solutions
“GDS”
Shanghai RAAS
(Mkt cap: €5.2bn)
CREAT
TianchengRAAS China
Grifols S.A.
(Mkt cap: €14.4bn)
34.9% 36.2%
100%
(26.2%) (25.8%) (26.7%)
(45.0%)
(89.88% ordinary + 1.08% pref.)(55.0%)
BPL
Free float
100%
(10.12% ordinary + 98.92% pref.)
Company Presentation Biotest AG 5
Financials H1 2019
Income statement(€ million)
H1 2018 H1 2019
Sales 200.7 195.1
Operating costs & expenses -200.1
Operating Profit (EBIT) 0.6 -5.5
Financial result, taxes -8.6 7.5
Earnings after tax (EAT) from Continuing
Operations
-8.0 2.0
Earnings after tax (EAT) from Discontinued
Operations
193.7 -
Earnings after tax (EAT) Biotest Group 185.7 2.0
Company Presentation 7Biotest AG
-200.6
H1 2018 H1 2019
EBIT reported 0.6 -5.5
Biotest Next Level costs* 23.7 34.5
Monoclonal antibodies 2.5 0.9
EBIT adjusted 26.8 29.9
Company Presentation 8Biotest AG
EBIT regular and adjusted(€ million)
*: including R&D costs for BNL development drugs
Biotest Next Level (BNL) costs in H1 2019
1. BNL facility costs: € 13.8 million;
- Facility costs (Energy, building costs, security, etc.)
- Depreciation
- Personnel costs (for ramp-up, commissioning etc.)
- Project Administration
2. BNL R&D costs in total: € 20.7 million; thereof:- € 9.9 million - IgG Next Generation
- € 5.8 million - Trimodulin (IgM Concentrate)
- € 5.0 million - Fibrinogen
Total BNL costs: € 34.5 million in H1 2019
9Biotest AGCompany Presentation
0
50
100
150
200
250
H1 2018 H1 2019
Sales development(€ million)
10
200.7195.1
-2.8%
Central
Europe
East & South
Europe
Inter-
continental
Middle East,
Africa &
France
35.1
44.8
41.8
32.4
54.6
36.6
74.4 76.1
Company Presentation Biotest AG
• Segment Plasma & Services:
Decline in contract fractionation
(Middle East), capacity used for
own production
Balance sheet (Continuing + Discontinued Operations)(€ million)
0
200
400
600
800
1.000
Current assets
Non-currentassets
11
1,058.21,042.3
31 Dec 2018
Assets Equity and Liabilities Equity ratio
30 June 2019:
46.9%1,058.2
496.2
415.6
421.5
495.2569.6
488.6495.1
547.2
146.4
125.6
Company Presentation Biotest AG
1,042.3
30 Jun 2019 31 Dec 2018 30 Jun 2019
Current assets
Non-current assets
Current liabilities
Non-current liabilities
Equity
1,000
800
600
400
200
0
Solid equity ratio
of 46.9%
Guidance 2019
Sales: In 2019 sales of continuing operations
will increase by a mid-single-digit
percentage
EBIT: Earnings will be influenced by various factors in 2019:
- Mainly further expenses as part of BNL expansion project of
€80 to 90 million (incl. associated BNL R&D costs)
- Tense situation in the crisis regions, particularly in the Middle East
- A partner is being sought for advanced development projects
Company Presentation 12Biotest AG
EBIT of continuing operations will be between €-5 m and
€ +5 m, if partnering can be successfully concluded in 2019
Strategy &
Market environment
0
50
100
150
200
250
2010 2011 2012 2013 2014 2015 2016 2017 2018e
IgG
Ma
rke
t S
ize
in
to
ns
North America Europe RoW
14
Global IgG (i.v. and s.c.) Market Size Development
IgG Market Size (Volume in tons)
• The global IgG Market reached a size of nearly ~200 tons in 2018.
• In the period 2010 to 2018, the total market grew by ~8% annually (CAGR)
Sources: Biotest Market and Pricing Insights based on MRB (2016, 2017), PPTA (2018), Markets and Markets (2017), Allied Market Research 2018, Credit
Suisse CSL US PPTA IG volume Jan 2019
Annual Growth –CAGR 2010 – 2018e
RoW 9%
Europe 8%
North America 8%
World 8%
Company Presentation Biotest AG
Global total IgG (i.v. and s.c.)
Geographical Volume Split – Development & Forecast
Biotest AG SB July 25, 201915
Sources: Biotest Market and Pricing Insights based on MRB (2016, 2017), PPTA (2018), Markets and Markets (2017), Allied
Market Research 2018, Credit Suisse CSL US PPTA IG volume Jan 2019
0
50
100
150
200
250
300
350
2010 2011 2012 2013 2014 2015 2016 2017 2018e2019e2020e2021e2022e2023e
IgG
Mar
ket
Size
in t
on
s
North America Europe RoW
• The global IgG Market reached ~200 tons in 2018 and is projected to reach > 300 t in 2023 at a
CAGR (2017 – 2023) of 9%.
• North America accounted for 47% of the market in 2018 and is estimated to reach 150 t by 2023
Annual Growth –CAGR 2010 – 2018e
RoW 9%
Europe 8%
North America 8%
World 8%
Das ist der Biotest
interner Forecast
241 238
201
172
151 149 146
126110
102 99 97 9382
75
47
23 2013
6 3 10
50
100
150
200
250
300
kG Ig
G/m
illio
n p
op
ula
tio
n
IgG usage per capita 2017Consumption
Source: IMS Midas (2017), PPTA (until Nov. 2017 for EU and Sep 2017 for US distribution data), MRB (2014, 2015, 2016), NBA Australia 2017, CIA
Factbook, except *: populationpyramid.net
• Increasing
consumption
worldwide
• Growing use in CIDP
in major markets
• Easier reimbursement
leads to market
growth
16Company Presentation Biotest AG
213*196*
91*
69*
99*
*IVIG usage per capita 2015
259 252
222
165
143 142 140129
119104 97
90
56
3426 22 20
12 10 8 4 1 1 00
50
100
150
200
250
300
USA
(e)
Au
stra
lia*
Can
ada*
(e)
Swit
zerl
and
(e)
Fran
ce
Au
stri
a
Ger
man
y
Irel
and
(e)
Netherlands…
Spai
n
UK
Ital
y
Turk
ey (
e)
Arg
enti
nia
(e)
Iran
(e)
Ch
ina
(e)
Hu
nga
ry
Bra
zil (
e)
Mex
ico
(e)
KSA
(e)
Ind
ia (
e)
Afr
ica*
(e)
Vie
tnam
(e)
Ro
man
ia (
e)
kg Ig
G/m
illio
n p
op
ula
tio
n
17
Global IgG Market – usage per capita 2018
Sources: Iqvia (2018), PPTA (2018 for EU and USA estimation based on CSL Analyst report May 2019), MRB (2014, 2015, 2016, 2017), NBA Australia 2018, CIA Factbook, except * populationpyramid.net
Comments• Increase of new PID
patients due to testing requirements in US: Continuous high demand
• Increased use of SCIG formulations
• Growing use in CIDP in major markets
• Increased need to treat SID due to more aggressive treatments
• Easier reimbursement leads to market growth
• Cost of treatment remains still a barrier to market expansion
• Claw back tax led to supply crisis in Romania
Ø per capita usage: 82 kgIgG/million population
Company Presentation Biotest AG
Immunoglobulines (IgG): Usage per capita in 2017
(kg per Mio. inhabitants; increase versus 2015 in %)
Biotest AG 18
• Rising global
consumption
• Significant growth
expected in the
Chinese market
• Consumption 2017:
20 kg/million
inhabitants
+13
%
+48
%
+39
%
+48
%
+21
%
Quellen: IMS Midas (2017), PPTA (bis Nov. 2017 für EU- und Sep. 2017 für US-Vertriebsdaten), MRB (2014, 2015, 2016), NBA Australia 2017, CIA Factbook, außer *:
populationpyramid.net
Company Presentation
Australia ..Spain....Germany....France….USA
Immunoglobulines (IgGs): Further increase of global
market volume expected(Market volume in tons)
Biotest AG 19
47
107
172197
226
335
2000 … 2010 … 2016 2018 2020 … 2026
2010 vs. 2000
+60 tons
2018 vs. 2010
+90 tons
2026 vs. 2018
~ +140 tons
Source: Marketing Research Bureau (March 2019)
Company Presentation
Biotest core business overview
20
Biotest is a vertically integrated business, from plasma collection through production and distribution
To treat disorders of
the immune systems
Passive immunity
against Hepatitis,
Cytomegaly,
Varicella etc.
To help body
control the blood
clotting
To treat low
blood volume in
critically ill
patients
Clotting FactorsHyper immuno-
globulins
Immuno-
globulinsAlbumin
Plasma Quarantine Fractionation Intermediates Purification Filling /
packaging
Finished
product
QC
Immunoglobulins
Hyper immunoglobulins
Clotting Factors
Albumin
Company Presentation Biotest AG
5 products out of 1 litre plasma
~ 12.5 t immunoglobulins
Inventment into BNL
Revenue /
litre plasma
Cost /
litre plasma
Gross profit:
€100 / l~€300 / l
~€200 / l
Revenue /
litre plasma
Cost /
litre plasma
~€550–€650 / l
~€240 / l
IgM &
Fibri-
nogen
Gross profit:
€310–€410 / l
Today (current factory) BNL ramped-up
3 products out of 1 litre plasma
Capacity expansion: ~ 6 t
21Biotest AGCompany Presentation
Product portfolio Biotest today / tomorrow
Today
Polyvalent IgGIntratect 5%
Intratect 10 %
Hyper – IgG/ Specialty productsHepatect (Hep B)
Zutectra (Hep B)
Fovepta (Hep B)
Cytotect (Cytomegalie)
Varitect (Varizella-Zoster)
Specialty productsPentaglobin (IgM enriched IgG)
Biseko
HaemophiliaHaemoctin (FVIII)
Haemonine (FIX)
Human AlbuminAlbiomin 5 %
Albiomin 20%
Tomorrow
Polyvalent IgG
IgG Next Gen
Specialty productsTrimodulin (IgM enriched IgG)
FibrinogenAcquired Fibrinogen def.
Congenital Fibrionogen def.
22
+
+
Biotest AGCompany Presentation
+
0
100
200
300
400
2016 2017 2018
StandardProducts
SpecialtyProducts
Biotest portfolio differentiation(€ million)
Company Presentation Biotest AG 23
Biotest has unique speciality
products in it´s portfolio:
- Cytotect
- Varitect
- Hepatect
- Zutectra
- Pentaglobin (IgM product)
- Biseko
- Speciality portfolio show
good growth rates
Therapy sales only
Expansion of plasma donation centres
Company Presentation Biotest AG 24
• Two new centres in Czech Republic
(Břeclav, Brno) in 2018
• One new centre in Germany (Hanover) and
one in Budapest (Hungary) in 2019
Europe: 21 centres
9
93
New plasma donation centre in Brno
Biotest plasma donation centres
Company Presentation Biotest AG 25
Research &
Development projects
Strategic pillars of BNL development program
27
F VIII Albumin Trimodulin FibrinogenIgG
F VIII Albumin IgGToday
BNL
• Globalization of products
• More products out of one litre plasma
• Specialty plasma products (high medical need)
Company Presentation Biotest AG
Everything Needs to Work Smoothly Together
24.06.2019 MAKING WAVES - Big Bang Meeting 28
BNL: Building and Equipment
Product Development
GxP Compliance
Research & development projects to market
• BNL product
development
• Life cycle
management
projects
2021
• IgG Next Generation
PID*
ITP**
• Albiomin
• Haemoctin
Today
29
>2021
• IgG Next Generation
Subcutaneous (SC)
Dermatology
• Trimodulin (IgM Con.)
• Fibrinogen
congenital
acquired
• Haemophilia A
Therapeutic
*: Primary Immune Deficiency; **: Idiopathic Thrombocytopenic Purpura
Biotest AGCompany Presentation 29
• New efficient production process with high IgG yield established
• "Master product" for the Biotest Next Level production plant
IgG Next Generation (IVIG)
Clinical development
• Phase III study in PID* (EU + US; study 991): enrollment completed,
treatment for children
ongoing
• Phase III study in ITP** (EU; study 992): study completed
Company Presentation 30Biotest AG
*: Primary Immune Deficiency; **: Idiopathic Thrombocytopenic Purpura
IgG Next Generation (BT595)
10% IVIg manufactured with a
new production process
Development of a subcutaneous (SC)
product (20%) has started
IgG Next Generation is intended to become
Biotest's world-wide IVIg with a focus on US market
and high price markets in EU and RoW
Master product for the planned Biotest Next Level (BNL)
production plant
Company Presentation Biotest AG 31
IgG Next Generation – Development Strategy
• Increase in IgG yield by 0.5 g/l plasma to 4.5 g/l plasma
• Process suitable for manufacturing of IgG Next Generation and IgM
Concentrate/Trimodulin
• Increase attractiveness by an state of the art SC product and
approval of additional indication(s) as life cycle management
• One product suitable for worldwide commercialization
• Optimization of product quality (e.g. low IgA and dimer content)
Company Presentation Biotest AG 32
Building on the Intratect experience to create an
optimized IVIG IgG Next Generation
Maintain:
No thrombogenic activity
Infusion rate up to 8 ml/kg/h with flexible infusion
protocols
Low ACA & polymer levels
High margins of safety for prions and viruses
Further improve:
Implementation of an additional purification
column to further reduce anti-A/anti-B antibody
levels
Increased immunoglobulin yield to 4.5 g/l
plasma
Company Presentation Biotest AG 33
Fibrinogen
Company Presentation Biotest AG
Indication:
Congenital fibrinogen deficiency and acquired
fibrinogen deficiency in the indication severe
spinal surgery
Status:
• Congenital Fibrinogen deficiency trail in
phase I/III
• Acquired Fibrinogen deficiency
in phase III
Source: IMS Data 2-2017, Internal Critical bleeding market research, Data provided by affiliate
34
Company Presentation
Fibrinogen - Point of care diagnostic
• In Germany and Austria the market growth was highly connected with
improved diagnostics
• ROTEM®/TEG® devices are established for point-of-care diagnosis and
treatment
• Especially important for acquired fibrinogen deficiency,
• to monitor decrease of fibrinogen levels during bleeding
=> triggered treatment decision
• to adjust dosing according to individual need
=> targeted dosing
Biotest AG 35
• Neutralization of multiple pathogens
• Binding of toxins and inflammation
activators
• Reducing the secretion of immune
mediators
• Immune modulation
Trimodulin - IgM-enriched ImmunoglobulinBroad therapeutic potential in severe infection
i.e. K. pneumoniae, P. mirabilis,
P. aeruginosa, E. sakazakii, Enterococcus
sp., Staph. aureus, C. difficile, C. jejuni,
C.albicans, E. coli, P. aeruginosa, S.
marcescens, Enterobacter sakazakii
Company Presentation 36Biotest AG
Trimodulin for treatment of severe community
acquired pneumonia (sCAP)
No comparable adjuvant therapy available
+ +
• Neutralization of bacterial toxins
• Reduction of overshooting immune-mediated tissue damage
• Reduced risk for severe sepsis, septic shock, respiratory and multi-
organ failure
Mortality
AntibioticsVentilation, hydration,
vasopressors,…
Causal
therapyTrimodulin
Supportive
therapy
Company Presentation Biotest AG 37
Competitor Mapping
24.06.2019 MAKING WAVES - Big Bang Meeting 38
No direct competitors – no IgM enriched immunoglobulins
on the market or in clinical trials
High medical need - mortality rate high despite antibiotics
Commercial advantageous pricing opportunity
home
hospital ICU
Broad spectrum monotherapy Broad spectrum
combination therapyAvycaz
Mono or combination antibiotics for intolerant patients
Xigris (withdrawn)Pentaglobin
Corticosteroids
Filters
low
pri
ce
hig
h p
rice
Trimodulin
Zerbaxa
Trimodulin – Upside Indications
24.06.2019 MAKING WAVES - Big Bang Meeting 39
Trimodulin
Peritonitis
MDR
NeonatalSepsis
Transplan-tation
Biotest Next Level: Progress in Dreieich
40
Equipment for the purification
of IgG Next Generation
handed over to Biotest
Technologically leading
system for virus inactivation
integrated
Qualifications of clean rooms
and media systems are in
progress to be approved by
Darmstadt Regional Council in
Q4/2019
Establishment and validation
of manufacturing processes is
ongoing to be approved in 2020
Summary
Next Steps
• Biotest Next Level progressing
• Clinical trials for new BNL products ongoing: IgG Next Gen, Fibrinogen;
Trimodulin in preparation
• Opening of new plasma collection centres in Europe
Company Presentation Biotest AG 41
Financial Calendar 2019/ 2020
Contact
Financial Calendar 2019
14 Nov 2019 Q1-Q3 Report 2019
30 Mar 2020 FY Report 2019
05 May 2020 Q1 Report 2020
Investor RelationsDr. Monika Buttkereit
Tel.: +49-6103-801-4406
Public RelationsDirk Neumüller
Tel.: +49-6103-801-269