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Biotest AG — Investor Presentation 2009
Mar 11, 2009
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Investor Presentation
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Biotest Group: Creating Value. Living Values.
Analyst Conference – Financial Year 2008 Frankfurt/Main, March 11, 2009
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 comparative figures relate to the corresponding last year´s period, unless stated otherwise.
Biotest Group: Highlights of 2008
- •Integration of BPC finalised
- •Further internationalisation of business in all segments
- •Plasma Proteins: product range broadened
- •R&D: important milestones reached
-
•Biotherapeutics: partnering of BT-061 initiated
-
•Microbiological Monitoring: innovation leader
- •Medical Diagnostics: clear signs of improvement
- •Sustained dynamic and profitable growth
Biotest Group: Creating Value. Living Values. Financials 2008
Biotest shares: turbulent year, but outperformance of SDAX
- • Biotest shares reached new record level in Aug. 2008: € 67.00 (ordinary shares), € 64.00 (preference shares)
- •Share price hit by global financial and economic crisis
020406080100120140160180200Jan 08 Dec 08 Ordinary shares ■ Preferance shares SDAXPrice as of end 2007 = 100
Biotest shares and SDAX in 2008 (index)
Strong overall revenue growth
Total sales volume (€ m)
- • Strong sales growth in 2008 in 5th consecutive year
- • Growth across all geographic regions and Plasma Proteins product groups
- • 73 % of sales in international markets (2007: 68 %)
Strong revenue growth in Plasma Proteins business
Sales volume Plasma Proteins (€ m)
- • Consolidation of BPC leads to sales volume jump
- • Sales BPC € 64.1 m, thereof Plasma: € 44.0 m
- • Outstanding: development of Intratect® / Intraglobin® (+27 %)
- • Stable sales with coagulation factors
Strong revenue growth in Microbiological Monitoring, moderate growth in Medical Diagnostics
Sales volume MD and MM (€ m)
- • Diagnostics business in two separate segments: Microbiological Monitoring (MM) and Medical Diagnostics (MD)
- • MM: strong growth in particular with heipha products
- • MD: sales with transfusion diagnostics (manual reagents and TANGO® optimo) up by 10 %, transplantation diagnostics down by 12 %
- • U.S.: 50 TANGO® systems placed by the end of 2008, more than doubled vs 2007
R&D Expenses: Continuous increase
• R&D expenses 2008 amount to 10.3 % of Group sales (2007: 10.6 %)
Plasma Proteins:
- • Application for European approvals (Zutectra®)
- •First time consolidation of BPC
- • Preclinical and clinical research in new indications
Biotherapeutics:
- • Progress of clinical and preclinical studies
- • Establishment of mAb production facility in Boca Raton
Earnings growth exceeds sales increase
EBIT and EBT of the Biotest Group (€ m)
- • EBIT increase due to higher sales volume and partially higher prices
- •EBIT-growth without BPC: 24 %
- • Marketing & Sales expenses grew due to higher sales volume
- • Administrative expenses up by € 14 m, thereof € 6.1 m BPC
- • Financial result: € -15.1 m (2007: € -8.2 m) – financing BPC
- • Net impact of foreign exchange rates on profit 2008: € 0.5 m
Plasma Proteins business drives EBIT
EBIT by segments (€ m)
| 2 0 0 7 |
2 0 0 8 |
% ( C j d b 3 4 i t h t B P m p e o u y w u : % ) 2 4 + S i i f i i f M d i t t g n c a n m p r o v e m e n o e • D i i d l i d t t t a g n o s c s u e o s r e a m n e t t s r u c u r e |
||
|---|---|---|---|---|
| P l P i t a s m a r o e n s |
6 0 8 |
8 1 2 |
||
| B i h i t t o e r a p e u c s |
1 4 7 - |
1 6 7 - |
||
| M i b i l i l M i i t c r o o o g c a o n o r n g |
4 8 |
5 0 |
||
| M d i l D i i t e c a a g n o s c s |
6 3 - |
3 3 - |
• | E B I T f R i l i t i i f l o e c o n c a o n n e n c e u |
| * R i l i t i e c o n c a o n |
6 1 - |
1 0 6 - |
b d S A P l h t e p e n s e s e o a n c y x u u |
* Reporting category in accordance with IFRS 8 (equal to non-operative segment Corporate)
- • EBIT of Plasma Proteins segment jumped by 34 % (without BPC: +24 %)
- • Significant improvement of Medical Diagnostics due to streamlined structure
- •EBIT of Reconciliation influenced
EAT: Tax ratio back to normal after considerableincrease in 2007
EAT of Biotest Group (€ m)
- • Strong rise in EAT mainly due to tax effect: tax ratio of 2007 was influenced by singular effects
- • Income tax expenses in 2008 € 12.4 m (2007: € 12.9 m)
- •Tax ratio 30.6 % (2007: 42.7 %)
- •RoCE: 10.4 % (2007: 7.8 %)
- • Earnings per ordinary share: € 2.17 (2007: € 1.39)
Balance Sheet: Solid financial structure
Balance sheet of Biotest Group (€ m)
Change in Assets:
- • Increase in current assets mainly due to higher inventories
- • Trade receivables down by 6.5 % due to higher use of factoring
- • Rise of non-current assets mainly due to investments in Dreieich
Change in Liabilities:
- •Equity up by profit after tax
- • Rise in current liabilities mainly due to higher trade payables
- • Equity ratio as of 31 December 2008 at 42.8 % (2007: 42.1 %)
Long term secure debt financing
Biotest Group: Maturity of financial
- • Total financial liabilities as of 31 December 2008: € 194.8 m (2007: € 188.8 m)
- • Successful renewal of working capital facility of € 40 m and new working capital line of € 10 m
- • Further financing available – but at higher interest rates
Global Economic Crisis: Limited impact until now, but higher vigilance is necessary
- •Most products of the Plasma Proteins segment are life saving in nature
- • Plasma Proteins segment with opportunities in both developed and emerging markets
But:
- •Pressure to reduce health care spending might (or will) arise
- •Foreign exchange rate risks
- •Increased risk of loss of receivables
- •Growing political instabilities in some countries
- •Access to short term and long term debt more expensive (if not more difficult)
100.0112.1105.5 105.485.4 82.7 82.675.7020406080100120Q1 Q2 Q3 Q4 Q1 Q2 Q3 Q4 2007 2008
Decrease of Revenue in Q4 2008 due to accounting effect* – no indicator for downturn
* Whole Russia Tender in Q3 instead of Q3 and Q4 −Revenue € 10 m / EBIT € 5 m
Decrease of Revenue in Q4 2008 due to accounting effect* – no indicator for downturn (2)
* Split-off of revenue from Russia Tender to Q3 and Q4 − Revenue € 5 m / EBIT € 2.5 m in each quarter
Outlook 2009
Good start in financial year 2009:
- •Upward trend in Revenue and EBIT continues
- •No severe effects of global economic crisis until now
But the downturn cycle will hit us as well. When? How fast? How hard?
- •Higher uncertainties and risks demand higher alertness and vigilance
- •Capital allocation discipline
- •Investments in capacity expansion and R&D
- • First cost cutting measures initiated, cost control further enhanced
Our goals for the year 2009:
- •Increase in sales of about 10 %, EBIT stable at € 55 m
- • EBIT 2009 on level of 2008 due to potential exchange rate impact and unabsorbed facility costs resulting from expansion of production capacity
Biotest Group: Creating Value. Living Values.
Plasma Proteins
Plasma Proteins: Acquisition of BPC leads Biotest to new dimensions
Plasma Proteins: sales volume (€ m)
*Sales Baxter without rec. Factor VIII / IX regenerative medicine and vaccines Sales CSL Behring without rec. Factor VIII Based on sales volume in local currencies
- • Sales in Plasma Proteins jumped by 37 %
- Contribution BPC: € 64.1 m
- Biotest sales grew stronger than Plasma Proteins sales of major competitors*:
- •CSL Behring: +34 %
- •Griffols Bioscience: +23 %
- •Baxter: +22 %
-
•Octapharma: 18 %
-
- Source: Company Data; Company Announcements
Plasma Proteins Markets: Growth rates declining – IVIGs remain driving force
Market volume for immunoglobulins still rising due to new indications
Market growth pF VIII almost stable at 3 %
- • Positive price trend for all products in key markets has ceased
- • Currently no uniform price trend can be observed
= growth rate
Source: Review of Australia's Plasma FactionationArrangements (Feb 2006); Biotest Market Research
Plasma Sourcing: Current strong growth will not continue
+ ltr. 5 m 2005-2012051015201996199719981999200020012002200320042005200620072008E2009E2010E2011E2012E Source: MRB, own estimate + 19,5 % p.a. 2005 - 2009
U.S. collected Source Plasma (million litres)
Our estimate: Sourcing capacities will be reduced by industry as reaction on decreasing prices. Supply will be adapted to industry growth rate of 6 to 8 %.
Extension of Biotest's production capacity
Fractionation:
- • Facility in Boca Raton will be completed by end of 2009: capacity 400.000 litres p.a.
- • Contract with Belgian partner CAF-D.C.F:
- •up to 300,000 litres p.a.
- •facility included in regulatory files
- • extends long-term relationship for another 10 years
Production of Immunoglobulins:
- • Extension of capacity at Dreieich (from 2 to 4 tons p.a.) completed, EMEA licence expected 19 March 2009
- • Extension of capacity at Boca Raton site to be finalised end of 2009
Plasma: Increased self-sufficiency rate guarantees enhanced independence from world market price
- • In 2008: 2 new plasmapheresis centers established
- • Last opening: center in Santa Fe, NM (started Feb 9, 2009)
- • Biotest now runs 21 centers
- •10 in Europe (GER, AUT, HUN)
- •11 in the United States
- • Self-sufficiency rate > 45 % by end of 2009
- • Biotest will continue to sell high priced sourced Hyperimmuneplasma to third parties
Biotest plasmapheresis centers in the U.S.
Plasma Proteins: Broader product basis enhances flexibility
- • Six European approvals for Plasma Proteins of Biotest
- • Sales basis broadened and further stabilised
- •Flexibility enhanced
- • International sales in Plasma Proteins segment increased from 69 % (2007) to 76 % (2008)
Plasma Proteins: Update on progress of clinical studies
| I M C t t g o n c e n r a e : |
P h I l b i d l d F b 1 6 2 0 0 9 t t t a s e p r o o c o s u m e a s p a n n e o n e r u a r y , S f 2 f 2 0 0 9 t t l i i l h I d l t i d t a r o c n c a p a s e e v e o p m e n n n q u a r e r o f A d i B d l i i l j t h b i i t i t d v s o r y o a r o r c n c a p r o e c a s e e n n a e |
|---|---|
| G ( S ) I V I U : |
f f R i t t t i t i t l h I I I t i l i l t d e c r u m e n o p a e n s o r p v o a p a s e r a s c o m p e e f 2 0 1 0 R i t t i i l l b t d t d e g s r a o n w e e x p e c e a e n o |
| ® Z t t u e c r a : |
( ), H t i t i B I l b l i L i T l t t i e p a s m m u n o g o u n s c v e r r a n s p a n a o n : f P h I I I t d l t d d b i t t d t l i d E a s e s u y c o m p e e a n s u m e o r a c e n r a s e u r o p f f t h i t i d A l t d d 2 0 0 9 a u o r s a o n p r o c e u r e p p r o v a e x p e c e o r e n o |
| ® C t t t o e c y : ( C M V t i ) p r e v e n o n |
C ( ) l i i l t d h I I I i t l i l t i t n c a s p a s e s c r r e n n r e -e a a o n p r o c e s s o u y u y v u t i i i t t d t d d o p m s e r e c r m e n a n s p r o c e r e s u u y u |
| ® I t t t : n r a e c |
C h i i d i h i i d P h I I I d l d t t t r o n c o p a c p a n s n r o m e a s e s c o m p e e y : u y % f E l l t l i i l i 3 0 t i t L b t c e e n c n c a r e s p o n s e n o p a e n s a o r a o r x y t l t d t i d t i f d i t i l t t h t p a r a m e e r s a r e e a a e o e n p r e c e c s e r s a a r e v u y v u l i k d i i t t t n e o p o s e o c o m e v u |
Cytotect® study is gaining speed
Study to prevent CMV infection and their sequelae in children of mothers who acquired a primary CMV infection during pregnancy
Pregnant women screened
Current status:
- •1,502 women have been screened
- •Very complex study protocol
- • Project is in re-evaluation process to optimise recruitment and study procedures
- • International extension of study ongoing
- • Number of women to be screened(initially: 20,000) can most probably be reduced
Intratect® Human Immunoglobulin G
Treatment of chronic idiopathic pain syndromes
• Treatment of patients previously non-responders to available commonly accepted pain therapies
Time course of VAS scales: mean values
Preliminary analysis of pain scales (visual analogue scale, VAS) proves benefit of treatment, i.e. decrease of VAS, in a relevant proportion of patients (ca. 30 %)
Biotest Group: Creating Value. Living Values.
Biotherapeutics
Biotest Biotherapeutics: Investments with high upside potential
Common characteristics of Biotestmonoclonal antibodies:
- •High medical need
- •Fast growing markets
- •Blockbuster potential
Biotest mAbs and major indications
| B T 0 6 1 - |
R h i d A h i i t t t e u m a o r r s, P i i s o r a s s |
|---|---|
| B T 0 6 2 - |
M l i l M l t u p e y e o m a |
| B T 0 6 3 - |
S i L t y s e m c u p u s E t h t d r e m a o s s a n y u t h t i o e r a u o m m u n e d i s e a s e s |
R&D-Expenses Biotherapeutics (€ m)
Biotherapeutics – A big and fast growing market
Volume of market for therapy (\$ m)
- • Strong growth in both indications mainly driven by biologics and new drugs
- • BT-061 with specific mode of action
- • After approval of BT-061: significant market potential for both targeted indications.
Psoriasis (Sources: L.E.K. and Biotest analysis 2009)
Biotest Analyst Conference - March 11, 2009 30
Overview clinical development of BT-061
Clinical Studies in preparation:
- •Phase II Psoriasis: submission postponed until effective s.c. doses identified
- •Phase IIb R.A.: planning of study is ongoing
Summary of results from ongoing clinical studies
Rheumatoid Arthritis −Phase IIa
- •Multiple dose escalation study
- •i.v and s.c. application
- • 75 % of patients receive BT-061, 25 % receive placebo
- • first effective s.c. dose levelsreached. Clinical response observed in62.5 % of patients
- • maximal efficacy is expected to be identified by further dose escalation in ongoing study
Psoriasis −Phase I/IIa
- •Single dose escalation study
- •i.v and s.c. application
- • 75 % of patients receive BT-061, 25 % receive placebo
- • in relevant therapeutic dose ranges (i.v.) clinical response observed in 75 % of all patients
- • individual patients show improvement of PASI score up to 88 %
- • long-lasting effect already at low doses
Until today 146 individuals have been enrolled. BT-061 was generally well tolerated.
BT-061: Results of Phase IIa dose escalation in Rheumatoid Arthritis (Study 962) in detail*
Improvement of symptoms after multiple s.c. application (%)
during ongoing trial
Partnering BT-061 on track
- •Biotest successfully initiated the Partnering process for BT-061.
- • Selected global pharmaceutical companies have been contacted to identify the future co-development and co-commercialisation partner.
- • The majority gave a very positive feedback and indicated interest. Biotest decided to step into further negotiations with a limited number of companies.
- • Currently, discussions under confidentiality agreement about scientific topics and business terms are continued.
- •Collaboration and license agreement planned for end of 2009.
Multiple Myeloma - unmet need and high market potential
(Source: SEER Cancer Statistics Review, 1975 - 2004)
BT-062: Clinical Development in U.S. centres started, so far promising results
BT-062 with unique mode of action:
Toxin moiety mediates high efficacy
Antibody moiety mediates high specificity
Phase I: Dose escalation study in patients with relapsed or relapsed/refractory Multiple Myeloma
- • Multi Centre trial in 4 US sites, open label, repeated single dose
- • Prior therapies: treatment with both an immunomodulator and a proteosome inhibitor therapy
- • Primary Objectives
- •Dose limiting toxicity
- •Maximum tolerated dose
- • Secondary Objectives
- •Anti-tumor activity
- •Qualitative and quantitative toxicities
- •Pharmacokinetics
- • Status
- •All sites open and recruiting
- •Patient recruitment in 4th dose level
So far the medication was generally well tolerated by the critically ill patients.
Monoclonal antibody projects are on track, promising data from clinical studies
- BT-061: First successful clinical efficacy data in Rheumatoid Arthritisand Psoriasis.
- • Partnering process started in 2008, should be finalised by end of 2009.
- • Biotest holds a variety of patents (including an US patent) and has submitted further patent applications.
- • BT-062 was so far generally well tolerated by critically ill patients (multiple myeloma).
- • Establishment of internal manufacturing (BPC, Boca Raton) proceeds according to plan.
Biotest Group: Creating Value. Living Values.
Microbiological Monitoring and Medical Diagnostics
Microbiological Monitoring: Ongoing success
- • Continuing success of heipha products in key markets
- • Bundling of heipha and HYCON R&D resources
- • New products enhance efficacy of monitoring processes
- • Focus in R&D on products enabling paperless laboratory
Medical Diagnostics: significant improvement
- • Transfer of activities in Biotest Medical Diagnostics GmbH successfully completed
- • Approval of manual transfusion reagents in U.S. – full-fledged supplier (one of only three)
- • Number of TANGO® systems placed in the U.S. doubled
- • EBIT still negative, but significant upward trend
- • Search for strategic partner continued and with high priority
Summary: Biotest made significant progress in implementation of its corporate strategy
- •Strong R&D pipeline: New products and new clinical indications.
- • Regulatory approval for IVIG expected end of 2010. Market potential for this product in USA estimated to be \$ 100 m.
- • Biotest will grow the Plasma Proteins segment by extending capacities in plasma sourcing and production.
- •Presence in the U.S. market increased.
- •Plasma Proteins: business grew stronger than market.
- • Biotherapeutics: strong clinical data facilitate search for co-development / comarketing partner.
- • Biotest expects further sales growth in 2009. The goal is to increase sales by more than 10 %.
Thank you for your attention!
Biotest Group: Creating value. Living values.