Biotest AG Press and Analyst Conference FY 2017 Frankfurt/ Main, 22 March 2018 - The site can't be reached.
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Biotest AG
.
Press and Analyst Conference FY 2017
Frankfurt/ Main, 22 March 2018
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,
p ,
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. The
previous year´s figures have been adjusted accordingly.
• All comparative figures relate to the corresponding last year´s period, unless stated
otherwise.
Company Presentation Biotest AG 2
Biotest Group: FY 2017 at a glance
• Guidance 2017 achieved
• Successful takeover byy Creat
• Transfer of BPC to US trust for divestiture
• Sales of Continuing Operations in FY 2017
at €378.1 m; EBIT in FY 2017 at €-9.3 m,
mainly due to albumin recall
• BPC closes sale of therapy business to
ADMA Biologics Inc., USA in June 2017
• Biotest Next Level project progressing
Company Presentation Biotest AG 3
Re-alignment of Biotest Group´s global business
Continuing Operations Discontinued Operations
Earnings &
US Trust
proceeds
100%
% 100%
% 100%
19 Plasma Biotest US
8 Affiliates collection Corp.
centres
100%
BPC
100% 41%
22 Plasma
collection
centres
Company Presentation Biotest AG 4
Expansion of plasma donation centres
Europa: 19 Center
• 3 new centre in Hungary
(Székesfehérvár, Debrecen, Kaposvár)
• 2 new centre in Czech Republic
(Prague, Břeclav (Jan 2018))
9
2
Plasma 19 centres 9 GER 8
donation
centres 8 HU
2 CZ
Company Presentation Biotest AG 5
Takeover by Creat and next steps
Takeover by Creat
• Jan 31, 2018: After last remaining condition (CIFIUS approval) was met, the
takeover of 89,88% of Biotest AGs ordinary shares and voting share
capital by Creat was closed
• Feb 8, 2018: Tiancheng (Germany) Pharmaceutical Holdings AG, a holding
company which is indirectly controlled by Creat Group Co., Ltd.,
investigates the intention to enter into a domination and profit and
loss transfer agreement with Biotest AG
Next steps:
• Analyse and implement potential synergies with BPL and Shanghai RAAS
Company Presentation Biotest AG 6
Global sales split per region:
Biotest, BPL, Shanghai RAAS
Biotest 2016* BPL 2016 Shanghai RAAS 2016
0,45%
3% 5% 3%
8%
30% 40%
61%
6% 44%
5% 100%
North America South America Europe Middle East APAC RoW
• Biotest's
Biotest s sales are focused on Europe and the Middle East
East.
• BPL is focused on Europe (almost exclusively UK) and the U.S.
• Shanghai RAAS sales are focused on the Asia & Pacific region, i.e. almost
exclusively on China.
*: without BPC (Continuing Operations) Source: Biotest: Internal numbers; BPL, Shanghai RAAS: MRB (2018); RoW includes Africa and Oceania.
Company Presentation Biotest AG 7
China is the blue Sea of the international plasma
products industry
Average consumption of immunoglobulin
Gram/1000 person/year, estimation of 2016
226
• In 2015, the scale of the
Chinese domestic plasma
product market is approx. 113 98
USD 2.51 billion
45
18
• The Chinese plasma
product market is still in its
early stage, and with the
development of the Average consumption of coagulation factors
Chinese economy and IU/
IU/person/year,
/ estimation
ti ti off 2014/15
consistent market 8,4 8,3
enhancement, the future 7,3
growth potentials are huge 5,8
0,1
Source: Biotest Market Research based on IMS Midas (2016), PPTA (2016), MRB (2013, 2014, 2015, 2016, 2017), WFH (2016) , CIA Factbook
Company Presentation Biotest AG 8
Financials FY 2017
Continuing vs. Discontinued Operations
(€ million)
Sales 2017 EBIT 2017
Continuing
C
Operations
Decision 378.1 `-9.3
to divest
Consequence
"US
for financial
Business"
reporting
to a US
Trust
Discontinued Sales 2017 EBIT 2017
Operations
Ope at o s
US Business 163.1 `27.3
Company Presentation Biotest AG 10Income statement
(€ million)
2016 2017
S l
Sales 408 0
408.0 378 1
378.1
Operating costs & expenses -372.8 -387.4
Operating profit (EBIT) 35.2 -9.3
Financial result, taxes, income from joint ventures -29.1 -7.1
Earnings after tax (EAT) from Continuing Operations 6.1 -16.4
Earnings after tax (EAT) from Discontinued Operations -51.8 12.9
Earnings after tax (EAT) Biotest Group -45.7 -3.5
Company Presentation Biotest AG 11EBIT regular and adjusted (Continuing Operations)
(€ million)
2016 2017
EBIT regular 35.2 -9.3
Biotest Next Level costs* 37.8 53.9
Monoclonal antibodies 11.2 7.6
Humanalbumin recall** 22.9
Strategic realignment (Creat) 11.5
EBIT adjusted 84.2 86.6
* The research and development cost for products that can be produced only at the new plant facility were added
to the costs for Biotest Next Level
** Considering the insurance compensation
Company Presentation Biotest AG 12Sales development (Continuing Operations)
(€ million)
-7.3%
408.0
400 25.9 378.1
Other Asia &
Pacific 18 3
18.3
120.1 Middle East • Slight increase in Rest of
99.5 Europe (+2.3%) due to
300 & Africa
increasing Pentaglobin
13.5 South 13.7 sales
America
200 • Albumin recall and shift of
140 2
140.2 143 4
143.4
Rest of tender orders affected
Europe sales in all other regions
100
108.3 103.2
Germany
0
2016 2017
Company Presentation Biotest AG 13Balance sheet (Continuing + Discontinued Operations)
(€ million)
Assets Equity and Liabilities Equity ratio
31 December 2017:
978 5
978.5 978 5
978.5 35 5%
35.5%
1.000
, 932.8 932.8
800 347.8 Current assets
530.9 360 7
360.7
465.6 Non-current assets
600 Current liabilities
Non current liabilities
Non-current
379.5
400 Equity
426.1
467 2
467.2 447 6
447.6 • Increase
I off non-currentt
200
assets due to BNL
251.2
146.0 investment
0
31 Dec 2016 31 Dec 2017 31 Dec 2016 31 Dec 2017
Company Presentation Biotest AG 14Cash flow from Continuing Operating activities 2017
(€ million)
34.4 -12.0
+10 1
+10.1
-4.1 -37.0
-45.2 18.3
+22.2
-23.2
-7 7
-7.7
Operating Cash Flow Δ Working Δ Interest & tax -16.1Cash flow from
before changes in capital expense operating
working capital activities
Company Presentation Biotest AG 15Guidance 2018
Sales: In 2018 sales of Continuing Operations will increase by a mid-single-digit
percentage
EBIT
EBIT: Earnings
E i will
ill b
be iinfluenced
fl dbby various
i ffactors iin 2018
2018:
- Mainly further increased expenses as part of BNL expansion project of
€60 to 70 million (incl. associated research and development costs )
¾ EBIT of Continuing Operations will be in the range of €10 to 12 million
Company Presentation Biotest AG 16Strategy & Market environment
Key pillars of Biotest’s strategy
• Drive organic growth with significant capacity and process investment of BNL
− Broadening of product portfolio
− Doubling of production capacity
− Improved yield
Additi
Additional
l products
d t ffrom every litre
lit off Plasma
Pl
• Capitalise on new product opportunities with strong in-house
in house R&D capabilities
− Focus on IgG Next Gen, Fibrinogen, Trimodulin (IgM Con.)
• Analyse and implement potential synergies with BPL and Shanghai RAAS
Company Presentation Biotest AG 18Research & Development projects
Research & development projects to market
Today 2021 >2021
BNL product
IgG
I G Next
N Generation
G i IgG Next Generation
development • PID* • Subcutaneous (SC)
Life cycle • ITP** • CIDP***
management
projects Albiomin Trimodulin (IgM Con.)
Fibrinogen
Haemoctin
• congenital
• acquired
Haemophilia A
Therapeutic
*: Primary Immune Deficiency; **: Idiopathic Thrombocytopenic Purpura; ***: Chronic Inflammatory Demyelinating Polyneuropathy, or other neurological indication
Company Presentation Biotest AG 20IgG Next Generation (IVIG)
• Development of successor of Intratect® helps patients with
immune system dysfunctions and some autoimmune disorders
• Global commercialisation planned
• New efficient production process with high IgG yield established
• "Master product" for the Biotest Next Level production plant
Clinical development
p
• Phase III study in PID* (EU + US): recruitment of adults completed –
recruitment of children ongoing
• Phase III study in ITP** (EU): recruitment of patients ongoing
• Phase III study in CIDP*** (USA + EU): study design in discussion with FDA
*: Primary Immune Deficiency; **: Idiopathic Thrombocytopenic Purpura; ***: Chronic Inflammatory Demyelinating Polyneuropathy, or other neurological indication
Company Presentation Biotest AG 21Fibrinogen: development for congenital fibrinogen
deficiencies
• Fibrinogen plays an essential role in blood clotting
• A sufficient plasma fibrinogen level is critical for effective haemostasis
Phase I/III study
congenital fibrinogen deficiency
9
Phase I: enrolment of patients ≥ 6 years
- completed
enrolment of children < 6 years
- ongoing
• Single dose of fibrinogen
• PK parameters and surrogate efficacy (MCF)
Phase III: ongoing
• On-demand prophylaxis / treatment
• Clinical
Cli i l efficacy
ffi / surrogate
t efficacy
ffi (MCF)
MCF = Maximum clot firmness.
Company Presentation Biotest AG 22Fibrinogen: development for acquired fibrinogen
deficiencies
• In acquired fibrinogen deficiency body's own coagulation factor fibrinogen is lost
i.a. due to major bleeding
• Replacement of lost fibrinogen is critical to restore effective haemostasis
Phase III study
acquired fibrinogen deficiency
Phase III: ongoing
• Patients undergoing
g g major
j spine
p surgery
g y
associated with excessive blood loss
• ADFIRST: Adjusted fibrinogen replacement strategy
• Phase III study approved in European countries
• Site initiation progressing (6 sites open)
• First patient treated in March 2018
Company Presentation Biotest AG 23Trimodulin (IgM Concentrate) project status
FDA and PEI feedback on quality of production process and
preclinical project status
• Further optimization according to latest scientific findings in the
production process in preparation for phase III readiness
• Opportunity to integrate successful process development work
into commercial production scale
Very
y positive feedback on clinical programme
g
• Only minor adaptations needed
• Study protocol in finalisation
• First steps with CRO were taken
Communication with experts and scientific advices lead to a clear
development path for the projectOverview monoclonal antibodies
Biotest develops the monoclonal antibodies until next milestones (finalization of clinical
studies) have been completed
Next steps: divestiture or spin-out
spin out
• Multiple Myeloma study (983, Phase I/IIa)
BT – 062 − 7 patients remain on treatment with stable disease or better
(CD138
ADC)
(33 to 54 months)
• Breast / bladder cancer (989, Phase I/IIa)
− Signs of efficacy observed in monotherapy
BT – 063 • Systemic Lupus Erythematosus study (Phase IIa)
(anti
(a t –
IL10)
− Treatment completed,
completed database locked
− Data evaluation started
BT – 061
(Anti
(Anti- • Initial
I iti l preclinical
li i l evaluation
l ti off a new indication
i di ti completed
l t d
CD4)
Company Presentation Biotest AG 25Biotest Next Level
Biotest Next Level
BNL & power
plant: ongoing
Expansion
fill&pack:completed
Expansion
E i Plasma receiving
Pl i i &
fill&pack: completed labs: completed
Company Presentation Biotest AG 27Biotest Next Level – successful GMP*- inspection
Milestones 2017
June
• New BNL B
N Building
ildi receives
i B
Building
ildi
approval and is released for commercial
use
August
• Successful GMP*-
GMP inspection by the
competent authorities (Regierungs-
präsidium Darmstadt)
• Laboratories start with their dailyy routines
GMP*= Good manufacturing practice
Company Presentation Biotest AG 28Biotest Next Level – update
Technical challenges in BNL solved
• During commissioning fragments were
observed in piping of media systems
and process equipment
• Cleaning of piping started immediately
• Back to operations since February 2018
Company Presentation Biotest AG 29Biotest Next Level – qualification process ongoing
March 2018
• All technical installations (power,
heating air-conditioning,
heating, air conditioning water/
waste water) as well as media
supply (e.g. compressed air, ultra
pure media, heating/ cooling
medium) have been installed.
Qualification runs are ongoing
• Installation of process equipment
(IgG, IgM, Fibrinogen and
Albumin) is completed.
Validation and qualification
ongoing
Company Presentation Biotest AG 30Summary
Next Steps
• Closing of BPC divestiture
• Analyse and implement potential synergies with BPL and Shanghai RAAS
• Biotest Next Level progressing
p g g
• 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 31Financial Calendar 2018
C t t
Contact
Financial Calendar 2018 Investor Relations Public Relations
.
15 May 2018 Q1 Report 2018 Dr. Monika Buttkereit Dirk Neumüller
15 May 2018 Annual shareholders' meeting
Tel.: +49-6103-801-4406 Tel.: +49-6103-801-269
14 Aug 2018 H1 Report 2018 investor_relations@biotest.de pr@biotest.com
14 Nov 2018 Q1-Q3 Report 2018You can also read
