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Biotest AG Investor Presentation 2011

Aug 31, 2011

66_rns_2011-08-31_b90ef807-f8e6-4b1d-81cb-39a3ab5bede1.pdf

Investor Presentation

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Company Presentation Biotest AG August, 2011

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. After the disposal of the transfusion and transplantation diagnostic activities to Bio-Rad Laboratories Inc., and the disposal of the Microbiological Monitoring to Merck KGaA these activities are being reported as Discontinued Operation.
  • All comparative figures relate to the corresponding last year s period, unless stated otherwise.

Biotest Group: Highlights H1 2011

  • Biotest H1 2011 Group Sales up by 4.9%; Increase largely attributable to an upfront payment by Abbott on a pro rata basis to the Biotherapeutics segment
  • H1 EBIT decreased by 2.9% due to difficult plasma protein market environment and unabsorbed costs in Boca Raton
  • Biotest and Abbott signed a Licence, Development and Commercialization Agreement for BT 061 in June 2011
  • Microbiological Monitoring: Closing of sale and purchase agreement with Merck KGaA Darmstadt, Germany on 1st of Aug.
  • Submission of BivigamTM BLA to FDA on Nov., 2010; first FDA inspections of clinical sites completed
  • New plasma protein products developments continue with high priority
  • Capacity expansion to meet future demand

Biotest: History and milestones achieved

1946:
Biotest
Serum Institut
GmbH
1948:
Test-Serum
Anti-D
1961:
New
production
facility at
Dreieich
1968:
First
subsidiary
outside Germany
(Italy)
1971:
Market
launch of
Intraglobin®
1987:
IPO
1991:
Start of
Microbiological
Monitoring
2004:
Start of
modernized
Plasma Proteins
production
2007:
-
Clinical testing of
monocl. antibodies
-Acquisition of Nabi
-Preference share in
SDAX
2010:
Divestment of
Medical Diagnostics
2011:
Divestment of
Microbiological
Monitoring
1946 2011
2003:
MAB development
Start of
2006:
of conjugate
for BT-062
2011:
License
In
Licensing
Agreement with
Abbott: Co
technology from
Development/Co
ImmunoGen for
Marketing BT-061

Big Success for Biotest's Biotherapeutics:

Biotest and Abbott signed a

"License, Development and Commercialization Agreement"

to ensure the further development as well as later on production and worldwide marketing and sales of BT-061

Biotest and Abbott Global Agreement towards BT-061

  • Upfront payment of USD 85 million; Total Potential Milestone Payments USD 395 million; Total Deal Value: USD 480 million
  • Biotest will be eligible to milestone payments pending completion of certain development, regulatory, commercial and sales milestones;
  • Biotest will receive royalty payments on net sales achieved outside Europe EU51)
  • For Europe EU5 cost/profit split agreed

Partnership Structure

  • Joint development by Biotest and Abbott
  • Biotest to co-promote BT-061 in Germany, France, United Kingdom, Italy, Spain
  • Abbott will have exclusive global rights to commercialize BT-061 outside the EU5
  • Biotest Pharmaceuticals Corp. to manufacture product for clinical trials
  • Abbott and Biotest will share responsibility for commercial production

1) Germany, France, United Kingdom, Italy, Spain

Biotest sold Microbiological Monitoring business to Merck KGaA

  • On 1 August, 2011 the agreement to sell the activities of the Microbiological Monitoring segment to Merck KGaA (Darmstadt/ Germany) went into effect (closing)
  • Transfer of activities to Merck KGaA as well as payment of the purchase price
  • Biotest received €50.8 million from the transaction. Subject to final cost and tax settlements, Biotest will receive profits from the sale of approximately € 30-40 million and the expected cash flow to Biotest will be in the range of € 40-50 million

Strong track record – Plasma Proteins Almost stagnation in Diagnostics Business

Biotest : Future corporate structure

Focus on Pharma Biotest will be a specialized pharmaceutical company with focus on Plasma Proteins and Biotherapeutics

Biotest Group

  • Headquarters in Dreieich/Germany (Frankfurt area)
  • Subsidiaries in 11 countries worldwide
  • Employees (FTE)*: ~1,600** Thereof 45% located outside Germany
  • Founded in 1946, IPO in 1987, SDAX in 2007 (preference shares)
  • Biotest shares:
  • 6,595,242 ordinary shares
  • 5,133,333 preference shares

Headquarter, Dreieich

*: as of 30 June, 2011 **: Continuing Operations

Shareholder structure

56.4% of total capital, and 100% of voting rights 43.6% of total capital, 0% of voting rights

* as of August 2011

Biotest Group overview

European production and distribution sites

Additional sites outside of Europe:

  • USA: Florida ( )
  • Brasil: Sao Paulo (established) ( )
  • Russia: Moscow (established) ( )
  • Distribution also via 69 distributors in 60 countries

Sales by region (H1 2011):

Biotest: a Specialized Pharmaceutical Company

Biotest AG
Pharmaceuticals
Divisions
Plasma Proteins
Extension into:

USA

Spain

Brazil

new indications

new products
Biotherapeutics

Clinical Development
ongoing

Production at BPC

New patents

License Agreement
Sales:

203.8 m
R&D
:
-

11.7 m
EBIT*:

28.0 m
Sales:

9.1 m
R&D
:
-

11.1 m
EBIT*:
-

3.2 m

* H1 2011

Plasma Proteins

Plasma Market situation - a challenging environment

Sales by region H1 2010 Sales by region H1 2011

Country Situation
Germany ok
EU ok
Asia weak ; tender business in Middle East lost due to
price pressure or weak prices
Russia weak; price pressure
  • No albumin available from US plasma to be sold in high price Chinese market
  • US sales increase due to sales from Abbott (Biotherapeutics segment)

Plasma Proteins – Efficient production network

  • Aquisition of Nabi Biologics in 2007 (USD 185 million)
  • 21 plasma collection centres
  • Level of self-sufficiency: 40% for standard plasma
  • Exchange of intermediate products from US to Europe planned for 2012
  • Network increases EBIT margin
  • Capex for investments in production in Dreieich and Boca Raton 2008-2010: ~ USD 110 m

** Production in Dreieich and capacities at partners

Plasma Proteins business at a glance

Biotest Plasma Protein products

Intratect®
Pentaglobin®
Hepatect®
Zutectra®
Cytotect®
Varitect®
Nabi HB
Haemoctin®
Haemonine®
Human
Albumin
Biseko
Infections,
immune
deficiencies
Hepatitis B
Cytomegaly
Varicella
Blood
coagulation
defects
Albumin and
protein
deficiencies
= Biotest products
= lead indications
  • Global market share IVIG: ~ 3%
  • Intratect® market share in GER, AUT: > 17%, in UK, CH, I: > 10%
  • World market leader with Cytotect® and Varitect®
  • Leading position with Hepatect® in Europe and Nabi HBTM in USA
  • Zutectra ® launch in Feb. 2010
  • Biotest covers full value creation chain: plasma sourcing, production, distribution

vertical integration leads to rationalisation and higher productivity

Biotest: A market leader in special preparations

Biotest plasma proteins in 2010: sales by product category

Hyperimmunoglobulins and special preparations are a very attractive segment:

  • Stable prices
  • High market entry barriers
  • Biotest is totally self-sufficient in hyperimmune plasma procurement

* Including special preparations (e.g. Pentaglobin®)

BivigamTM (IVIG) FDA filing in US

Polyspecific immunoglobulin

  • BivigamTM FDA filing on Nov. 3, 2010
  • FDA confirmed that BLA dossier is generally accepted; FDA inspections of clinical sites completed
  • Restart of production in August after solving severe problems with the automation and control system
  • Additional conformance lots to be produced in Q3/4 2011

US Market entrance of strategic importance to Biotest Market potential ~ USD 100 m

Major progress in development of Plasma Proteins (I)

Zutectra®
s.c. Hepatitis Immunoglobulin
FoveptaTM
(s.c. Hepatitis
hyperimmunoglobulin
for neonates)
®
Cytotect
70
Successful market
introduction in
Germany, Austria, Italy,
Ireland; extension to
other countries is
planned
Study report finalised
in Feb. 2011
PEI submission in
April 2011
Interim analysis planned
for Dec. 2011
Currently 8.500 woman
screened in phase III trial

R&D expenses in H1 2011 in Plasma Protein segment: € 11.7 m

Major progress in development of Plasma Proteins (II)

IgM Concentrate Intratect 10% CivacirTM Fibrinogen
IgM enriched
Immunoglobulin
Polyspecific
Immunoglobulin 10%
Hepatitis C
Immunoglobulin
Indication: acute
bleeding disorders
High functional activity
Phase II study has
started
Phase III trial
Patient recruitment
completed
End of study Q1 2012
Approval expected
Q4 2012
New production
schedule; formulation
improved
Restart of clinical
development planned
for 2012
Product characteristics
have been defined
Start of clinical
phase I/II in Q1 2012

Biotherapeutics

Biotest's Biotherapeutics portfolio

BT-061 BT-062 BT-063
Activated Tregs mediate
modulation of T effector cells
Targeted Antibody Payload
(TAP) technology
Blockage of immuno
regulatory cytokine with key
role in pathogenesis of SLE
Potential Indications

Rheumatoid Arthritis

Psoriasis

Other autoimmune
diseases
Potential Indications

Multiple Myeloma

Solid tumors
Potential Indications

Systemic Lupus
Erythematosus
(SLE)

Oncology

Biotherapeutics: Significant project progress in 2010 and 2011

BT-061 − Specific mode of action addressing key regulatory function of the human immune system

Mode of action offers significant potential in several upside indications

Competitive Environment

  • Many candidates stopped within last two years due to lack of clear differentiation
  • Pipeline dominated by "me too" candidates
  • Only few innovative products in development, but required to further improve patient safety

Clinical development BT-061 Overview

Rheumatoid Arthritis Psoriasis
Trial Status Trial Status
Phase IIa, monotherapy
(No. 962)
96 patients
Completed Phase I/IIa, monotherapy
single dose (No. 967)
55 patients
Completed
Phase II, combination
with MTX (No. 971)
114 patients
Completed Phase II, monotherapy
multiple dose
(No. 973)
48 patients
Treatment *
completed
Phase IIb, combination
with MTX (No. 979)
176 patients
Recruitment
ongoing
Final evaluation
ongoing

*: Last patient last visit

Rheumatoid Arthritis Market:1 Continuous Growth until 2014 Driven by Biologics

Rheumatoid Arthritis Phase II Study (No. 971)

Preliminary analysis: Favourable Efficacy Results

50 mg BT-061 SC + MTX ACR scores [%] at primary endpoint (week 9)

BT-061: only patients that received the complete 8 week treatment cycle were considered for calculation 1) Biotest analysis of trial results of approved biologics

Please note: Trial results (average) from independent trials are shown, which are not directly comparable as patient characteristics, route of administration, dose levels and treatment frequency are different

BT-061: Ongoing and planned clinical trials

Higher patient numbers to confirm product profile seen in early trials

Rheumatoid Arthritis, Phase IIb (979)

  • − Confirm/establish superior efficacy and tolerability with larger patient basis
  • − Establish Proof-of-Differentiation
  • Design: 175 patients in 3 dose groups, 12 weeks treatment, 12 weeks follow-up

Pharmacokinetic/Pharmacodynamic Study – planned

  • − Extend current clinical pharmacokinetic and pharmacodynamic data set
  • − Support dose and schedule finding for phase IIb/III
  • Design: about 40 subjects in several dose groups

Rheumatoid Arthritis, Phase IIb - planned

  • − Confirm favourable compound properties seen in earlier trials
  • − Establish statistical basis for Phase III
  • Design: 350 patients in North America and Europe

Further monoclonal antibodies in clinical development

Company Presentation

Competitive edge BT-062

Intrinsic properties provide basis for product positioning

Toxin moiety mediates high efficacy

  • High potency independent of patient s immune system
  • Toxin technology with best track record: Sanofi Aventis, Biogen Idec, Bayer, Roche/Genentech amongst licensees

Antibody moiety mediates high specificity

  • Unique targeting to CD138
  • CD138 highly overexpressed in MM and other cancer cells
  • CD138 not expressed on bone marrow stroma cells
  • Good tolerability up to 160 mg/m2

BT-062: Summary

Study Dosing
Regimen
Results
Monotherapy
(No. 969)
USA
Repeated single dose Maximum tolerable dose (MTD)
cohort defined
Good tolerability
Clinical
Benefit in >50% of patients,
including minor and partial responses
Monotherapy
(No. 975)
USA
Multiple
dose, more
intense dosing scheme
Good tolerability in first patients
No
efficacy results available yet
Combination
therapy (No.
983)
Start
planned end of
2011

BT-062: Repeated Multi Dose Study 975 Duration of Study Treatment (29 August 2011)

  • 14 patients have been treated within one of the first 4 dose levels
  • Currently 8 patients receiving ongoing treatment
  • 6 patients at low dose levels completed study due to disease progression (DP)
  • BT062 up to now well tolerated, no DLT reported

Subject

Financials H1 2011

Revenue growth in difficult market environment

Revenue (in € m)

  • H1 2011 Sales at € 212.9 m, a growth of 4.9% vs € 202.9 m in H1 2010
  • Increase largely attributable to an upfront payment by Abbott on a pro rata basis to the Biotherapeutics segment
  • Sales in the Plasma Protein segment remained constant
  • Prices under pressure, particularly in markets outside the EU and the US

Despite sales growth, EBIT decreased

EBIT (in € m)

  • Despite 4.9% sales growth, EBIT decreased by 2.9% vs H1 2010
  • Continuing price pressure for immunoglobulins and clotting factors, especially in Eastern Europe and Middle East
  • Unfavourable cost of sales ratio primarily caused by pressure on prices of plasma proteins, a less favourable product mix and unabsorbed costs in connection with delays in the restart of production at Biotest Pharmaceuticals Corporation (BPC), Boca Raton, USA

H1 2011: EBIT Biotest Group (€ m)

H1 2011 H1 2010
Plasma Proteins 28.0 35.8 -
21.8 %
Biotherapeutics -
3.2
-
10.4
69.2
%
Corporate -
4.8
-
4.8
-
Biotest Group* 20.0 20.6 -
2.9 %

*: Continuing Operations

Decrease in EBIT and EBT in H1 2011

EBIT and EBT (in € m)

Financial result H1 2011: - € 2.6 m

  • Various re-valuations of Greek zero bonds
  • Lower interest expenses

Low EAT

EAT (in € m)

  • Earnings after tax decreased by 12.1%
  • Tax rate 26.9% in H1 2011 vs. 29.5% in H1 2010
  • Lower tax rate due to losses in countries with high tax rates (BPC/ USA) and some higher profits in countries with low tax rates

Outlook

Guidance 2011:

  • Sales: Sales to grow with a low single digit percentage compared to 2010
  • EBIT: EUR 40 million range

The guidance does not take into consideration any ! extraordinary income from discontinued operations.

Outlook Biotest Group

  • Growing demand for IVIG and albumin
  • Stable market for clotting factors and albumin
  • BivigamTM market authorisation expected mid of 2012; annual market potential ~ USD 100 m
  • We expect a further reduction of oversupply and improving market conditions in H2 2011
  • Promising R & D pipeline for Plasma Proteins and Biotherapeutics