Post on 14-Aug-2020
Think overThink over.Think ahead.
Think new.Annual Shareholders' Meeting of Biotest AG 7 May 2015Annual Shareholders Meeting of Biotest AG, 7 May 2015
Annual Shareholders' Meeting 2015 1Biotest AG
C t D l t t li b (BT 061)Current Development – tregalizumab (BT-061)
• Initial data from the TREAT 2b studyInitial data from the TREAT 2b study published
• Primary endpoint not met after 12 weeks of treatment12 weeks of treatment
− None of the three tregalizumab dose groups showed significant statistical improvement compared to the placeboimprovement compared to the placebo
− Lack of safety concerns is a positive aspect
• Further, detailed data under analysis
• AbbVie decision on next steps within 90 d90 days
• If development is fully stopped, € 25–30 million burden on profits for 2015
2Biotest AGAnnual Shareholders' Meeting 2015
FY 2014 At l
• New sales record: increase by 16.2% to
FY 2014 – At a glance
New sales record: increase by 16.2% to € 582.0 million
• Operating profit (EBIT) is stable at € 53 4 million despite increased R&D costs€ 53.4 million, despite increased R&D costs and headwind from the US and Russia
• R&D projects proceeded as planned
− Civacir®: phase III− Tregalizumab (BT-061): "Treat 2b"− Indatuximab ravtansine (BT-062):Indatuximab ravtansine (BT 062):
phase II
• "Biotest Next Level" is on course
3Annual Shareholders' Meeting 2015 Biotest AG
Biotest AG in figuresFY 2014 and Q1 2015FY 2014 and Q1 2015
4Annual Shareholders' Meeting 2015 Biotest AG
W ld id l thWorldwide sales growth
Sales by region (€ millions)
600 582.0+16.2%
Sales by region (€ millions)
26.9 • Growth in all regions
400
500500.8
Middle East & Africa
Other Asia & Pacific 152.3
120.0
23.6
Growth in all regions
• Strong demand in Asia, increased plasma sales in
300
400North and
South America
108.786.1
pthe US
• Almost 82% of sales achieved
100
200 OtherEurope177.7 188.1
through international markets
0
100
2013 2014
Germany93.4 106.0
2013 2014
5Annual Shareholders' Meeting 2015 Biotest AG
St bl EBITStable EBIT despite increased costs for Research & Development and "Biotest Next Level"
70EBIT (€ million)
• Lower sales of Bivigam® in the US
50
60
70-0.7%
53.8 53.4
Lower sales of Bivigam in the US due to strong competition
• Headwind due to political crises and ongoing price pressure
30
40
50 and ongoing price pressure
• Increased costs for R&D due to early production of study material (BT 061 Civacir ®)
20
30 (BT-061, Civacir ®)
• Increased costs as planned for "Biotest Next Level" (BNL)
0
10
FY 2013 FY 20142013 2014
• EBIT margin: 9%
6Annual Shareholders' Meeting 2015 Biotest AG
T t l t fl t thTotal assets reflect growth
Financial status of the Biotest Group (€ million)Financial status of the Biotest Group (€ million)at the end of FY 2014
Assets Liabilities
1,000886.5
1,032.6
886.5
1,032.6
353 3
600
800 Current assets
Non-current assets
Current liabilities
480.2
460.7
353.3324.0
400
Non-current liabilities
Equity
301 5679.3562.5 423.5
0
200Equity ratio
at 31 December 2014: 46 5%
124.3
301.5
128.90
7
2013 201446.5%
2013 2014
Annual Shareholders' Meeting 2015 Biotest AG
B i d l t Q1 2015Business development Q1 2015
160
Sales (€ million)• Significant sales increase (16.6%),
120
140
160142.5
122.2
Significant sales increase (16.6%), especially in the US and Germany
• Ongoing price pressure in individual product areas and
80
100
individual product areas and regions
• Increased costs (unabsorbedcosts R&D BNL) lead to an EBIT
40
60costs, R&D, BNL) lead to an EBIT decrease from € 10.7 to 0.1 million
• Guidance 2015 confirmed (subject to tregalizumab burden):
0
20
Q1 / 2014 Q1 / 2015
to tregalizumab burden): sales growth percentage in the lowsingle-digit range;EBIT: ~ € 50 million
8Annual Shareholders' Meeting 2015 Biotest AG
Corporate strategy
9Annual Shareholders' Meeting 2015 Biotest AG
St t iStrategy overview
• Consistent development of own Research &Consistent development of own Research & Development work
• Focus on marketing and development of biological products in the three indicationbiological products in the three indication areas:
− Haematology− Clinical immunology− Intensive care medicine
• Doubling of capacity by 2020 is proceedingDoubling of capacity by 2020 is proceeding as planned
Target: € 1 billion in sales by 2020
10Annual Shareholders' Meeting 2015 Biotest AG
W ld id i l b li k t thWorldwide immunoglobulin market growth
250
s
North America Europe RoW
Expected average growth per year
US Europe Rest of world
150
200
olum
e in to
n
g p y2014 – 2020e
Rest of world 11%
50
100
G m
arket v
o
Europe 4%
US 5%
0
50
2013 2014e 2015e 2016e 2017e 2018e 2019e 2020e
IgG US 5%
Total 6%
• Increase of worldwide demand by around 60 tons by 2020; Biotest is expanding its own production capacities by around 7.5 tons participation in the growth
• Ongoing price pressure in individual product areas and regions international
11Annual Shareholders' Meeting 2015 Biotest AG
• Ongoing price pressure in individual product areas and regions international representation of Biotest
"Biotest Ne t Le el""Biotest Next Level":On track in terms of timeline and budget
Biotest planning to double capacity by 2020 as prerequisite for billion in sales
Annual Shareholders' Meeting 2015 Biotest AG 12
"Biotest Ne t Le el""Biotest Next Level":Other projects about to be completed
• Day care centre (July 2015)
• Plasma receipt area and virological testing laboratory ( )(November 2015)
1313Annual Shareholders' Meeting 2015 Biotest AG
Research and Development
Annual Shareholders' Meeting 2015 14Biotest AG
N d t i th i li
Clinical Intensive care
New products in the pipeline
HaematologyClinicalimmunology
Intensive care
medicine
2015 2020
Civacir®
Tregalizumab (BT-061)
IgG Next Generation
Indatuximab ravtansine (BT-062)
IgM Concentrate
Fibrinogen
15Biotest AGAnnual Shareholders' Meeting 2015
BT-063
Ci i ® A i i t
• Civacir® is a hyperimmunoglobulin to treat Hepatitis C patients during and immediately
Civacir® – A promising agent
after liver transplantations
• There are 130 to 150 million Hepatitis C patients and approx 10,000 liver transplantations worldwide
• There is currently no standard therapy for preventing re-infection after transplantations
• Civacir® is produced by collecting antibodies from hundreds of plasma donors®• Civacir® binds to the virus and neutralises it
HCV mutation
Civacir® antibody
16
Civacir antibodydiversity
Biotest AG
*HCV = Hepatitis C virus
Annual Shareholders' Meeting 2015
Ci i ® I t i t d ltCivacir® – Interim study results
• Interim results from the phase III study wereInterim results from the phase III study were presented at the 50th International Liver Congress in Vienna (April 2015)
• Results:Results:
− If patients are treated with modern virostatics and without Civacir® prior to the transplantations (control group)the transplantations (control group), approximately 32% of patients are re-infected
− In patients who received Civacir®, there has been only one re-infection to date (5%)
• Final study results expected to be available y pin Q4 2015
• Market launch planned for 2017/2018
17Biotest AGAnnual Shareholders' Meeting 2015
I d t i b t i (BT 062)Indatuximab ravtansine (BT-062)
• Antibody Drug Conjugate (ADC), anAntibody Drug Conjugate (ADC), an innovative therapy approach for the treatment of multiple myeloma
• Combination of antibody and cytotoxic agentCombination of antibody and cytotoxic agent targets cancer cells
• Combination of efficacy and tolerability
• Final study data in Q4, decision from ImmunoGen 60 days later
potential milestone payment
• Utilisation of significant, additional potential possible by addressing solid tumours (breast and bladder cancer) with BT-062
18Biotest AGAnnual Shareholders' Meeting 2015
Oth i i d l t j tIgM Concentrate• Treatment of community acquired pneumonia
Other promising development projects
• Treatment of community acquired pneumonia• Study results (phase II) expected shortly
IgG Next Generation• New development of Intratect® and Bivigam®
helps patients with immune system dysfunctions.Gl b l k i l d
Fibrinogen• Fibrinogen is for the treatment of acute
• Global marketing planned
ghaemorrhages due to congenital or acquired fibrinogen deficiencies.
BT 063BT-063• Monoclonal antibody for the treatment of the
autoimmune disease Systemic Lupus Erythematosus
19Annual Shareholders' Meeting 2015 Biotest AG
Erythematosus
• Phase IIa study submitted to authorities
Bi t t h A lid i t tBiotest shares – A solid investment
• Share split 1:3 proposedShare split 1:3 proposed
− Goal: increase liquidity of the shares
− No dilution of sharesNo dilution of shares
• Controlling and profit/loss contract with Biotest Pharma GmbH
− Increasing synergies
− Tax savings (business and profits)g ( p )
− Lower annual statement costs
• Extension of share buyback• Extension of share buyback
20Annual Shareholders' Meeting 2015 Biotest AG
Si th ti di id d i
€
Sixth consecutive dividend increase
0,65
0,70€
• Dividend proposalfor FY 2014:
0,55
0,60 − € 0.60 per ordinary share
− € 0 66 per
0 45
0,50
0,55 € 0.66 per preference share
• Overall distribution:
0,40
0,45 O e a d st but o€ 8.3 million (+5%)
• Distribution ratio: 29%
0,30
0,35
2008 2009 2010 2011 2012 2013 2014*2008 2009 2010 2011 2012 2013 2014
Ordinary share Preference share
21Annual Shareholders' Meeting 2015 Biotest AG
Vi i St t i tl kVision – Strategic outlook
• The year 2015 is exciting and decisiveThe year 2015 is exciting and decisive
• Important study data and decisions from collaboration partnersp
• "Biotest Next Level" as basis for considerablegrowth in the plasma protein businessFocus on sales target of € 1 billion by 2020
• Further development projects promise dditi l t ti ladditional potential
22Biotest AGAnnual Shareholders' Meeting 2015
Biotest AG
Annual Shareholders' meeting 2015
Annual Shareholders' Meeting 2015 23Biotest AG