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Biotest AG — Investor Presentation 2016
Nov 10, 2016
66_rns_2016-11-10_fdadd0f1-7e74-4e7c-8061-a7969c5b6016.pdf
Investor Presentation
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Biotest AG.
Analyst Conference Q1-Q3 2016 Frankfurt November 10Frankfurt, 10, 2016
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 p , lans 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: Q1-Q3 2016 at a glance
- • Sales in Q1-Q3 2016 up by 9.0% to €455.6 m vs. €417.9 m in previous year period; Increase largely attributable to an increase in volume
- • Q1-Q3 2016 EBIT increased to €26.1 m vs. -€82.0 m in the p y revious yea r
- • Extraordinary tax and interest payment of €14.5 m for final settlement for Biotest AG with respect to business in Russia
- • Opening of five plasma collection centres in the US (3) and Hungary (2) in (2) to date
- •"Biotest Next Level" project is on track
- •Guidance confirmed
Worldwide sales increases
Salesby region (€ million)
- • Markets of North/ South America and Middle East & Africa and other Asia & Pacific made most significant contribution to growth
- • Highest growth rates in the US with +43.5%
- • Decrease in Germany due to one time effect of high plasma sales in previous year period p yp
EBIT and EBITDA (€ million)
Company Presentation Biotest AG 6
Reported EBIT significantly influenced by mAb and Biotest Next Level (BNL) (€ million)
mAb = monoclonal Antibodies
Financial position: strong equity base
Fi i l iti f th Bi t t G (€ illi ) Financial position of the Biotest Group million)
Positive cash flow from operating activities
January – September 2016 (in € million)
Cash flow from operating activities
January – September 2016 (in € million)
| i C F b f h i W k i C i l t t |
6 4 |
4 3 7 |
|---|---|---|
| p e r a n g g e o r e c a n g g e s n o r n g g a p p a |
||
Q1-Q3 2015 Q1-Q3 2016
| C h f l f i i i i t t t a s o w r o m o p e r a n g a c v e s |
3 4 2 |
4 6 9 |
|---|---|---|
| I t t d t i d n e r e s a n a x e s p a |
1 5 6 - |
2 5 3 - |
| C h f l f h i W k i C i l t a s o w r o m c a n g e s n o r n g a p a |
4 3 4 |
2 4 9 |
O
Positive development of key figures Sales, operating Cash Flow, EBITDA, EBIT
Company Presentation Biotest AG 13
Update BPC
- • Kedrion Distribution & Commercialisation Agreement with BPC has a positive impact on business on
- • Bivigam® batches on risk:
- −Reduction of risk by € 3 5 million to 3.5 € 6 5 million 6.5
- − In Q3 2016 some of the batches in question were inspected and approved within internal quality systems
- •Opening of three plasma collection centres in the US
Research & Development projects
Biotest product and R&D portfolio
First Patient treated in global pivotal trial with IgG Next Generation (IVIG)
IgM Concentrate – preparation of phase III in sCAP
Fibrinogen
Fibrinogen:
Fibrinogen is a plasma-derived clotting factor for the treatment of acute haemorrhages due to congq g enital or acquired fibrinogen deficiencies
Congenital Fibrinogen Deficiency
•Phase I/III study: phase III part approved and ongoing
Acquired Fibrinogen Deficiency
- •Paul Ehrlich Institute (PEI) supports Biotest concept of phase III study
- •Phase III in acquired fibrinogen deficiency planned to start in 2017
BT-062 Indatuximab RavtansineOverview
- • Antibody Drug Conjugate (ADC), an innovative therapy approach for the treatment of multiple myeloma
- • Combination of antibody and cytotoxic agent targets cancer cells
- •Combination of efficacy and tolerability
- • Multiple myeloma: all patients recruited, treatment ongoing; poster presentati f on o study at ASH* conference
- • Solid tumours: breast and bladder cancer; phase I completed, phase IIa study ongoing
* ASH = American Society for Haematology, Dec 3-6 , 2016 in San Diego, USA; abstract online since Nov 3, 2016
BT-062 phase I/IIa study no. 983 in Multiple Myeloma Results of BT-062 with Pomalidomide / Dexamethasone
- • A t t l f 17 ti t ll d D t t ASH*total of 17 patients were enrolled; Data at
- •3 patients were not evaluable for response (less than 2 complete treatment cycles)
- •11/14 = 79% showed an objective response (≥ PR) to treatment
- •7 patients without progressive disease for more than 12 months than 12
* ASH = American Society for Haematology, Dec 3-6 , 2016 in San Diego, USA; abstract online since Nov 3, 2016
Indatuximab Ravtansine (BT-062) Solid Tumor Study no. 989 ongoing - current status
| S i d d t e s g n u y : I d i i t n c a o n s : |
T i l i b d d d b l d d t t r p e n e g a v e r e a s c a n c e r a n a v a n c e a e r c a n c e r |
|---|---|
| / O O b b j j i i d i t t e c e s e s g n v : |
T l l t t h h k k i i t t i i f f t t d d t t i i- t t t t i i i i t t f o e v a u a e p a r m a c o n e c, s a e y a n a n u m o r a c v y o I d i b R i ( B T 0 6 2 ) i l d l i d i d i i t t t t t n a m a a a n s n e n s e e c e s o m o r n c a o n s u x v u - |
| ¾ ( ) P h I D l t i t i t l t d d M T D a s e o s e e s c a a o n o m a m m o e r a e o s e : x u |
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| ¾ f P h I I T t t t i t t l t d d l l l l. a s e a : r e a m e n o p a e n s a s e e c e o s e e e v v e e |
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| C t t t r r e n s a s u u : |
i l d d h b i d i f i d d 3 9 i t t t t t M a x m u m o e r a e o s e a s e e n e n e a n p a e n s - l l d d d t t w e r e e n r o e a n r e a e N d d i i l i i d l f d i- t t t t t t t t o a o n a p a e n s r e q u r e o e v a u a e s a e y a n a n u m o r - i i f B T 0 6 2 R l h i i h d b i f i d h h t t t t t t t t t a c v y o e e v a n a u o r e s a e e n n o e a e - i f i l d b i d t t t t t t r e c r u m e n o p a e n s w o u n o e c o n n u e |
| N t t e s e p s x : |
A h d i f i l i d d l d B i i l l t t t t t t s s o o n a s e s u y s n a z e a n e v a u a e o e s w r e p o r l t r e s s u |
Interim analysis supports continuation of phase IIa trial in SLE* with BT-063
Clinical proof of concept study phase IIa study no. 990
Patients with moderate to severe SLE on stable medication with joint and cutaneous manifestations
Duration: 3 months treatment + 4 months follow up
Study endpoints:
- •Primary: Incidence of adverse events, changes of safety parameter
- •Secondary: Improvement of joints, improvement of skin, SLEDAI**
Status:
• The Data Safety Monitoring Board (DSMB) recommends the continuation of the study based on interim analysis from part I of the study.
*: SLE = Systemic Lupus Erythematosus ** SLEDAI: SLE Disease Activity Index
Biotest Next Level On track in terms of timeline and budget (October 2016)
Biotest Next Level - construction works on track
- •Building shell is completed
- • Interior fitting/ work (clean (clean-rooms laboratories cold rooms, laboratories, cold-rooms doorways etc ) are rooms, etc.) about to be completed
- • Technical installations (power heating air Technical (power, heating, air-conditioning water/ waste water) as well conditioning, as media supply (e.g. compressed air, pristine steam/ vapor, heating/ cooling medium) is currently being commissioned. In parallel the qualification of operations is ongoing
- •Installation of process equipment has started
Biotest Next Level Impressions from inside (1)
Biotest Next Level Impressions from inside (2)
Guidance 2016 confirmed
- Sales: In the financial year 2016 sales will grow in a low single -digit percentage range
- EBIT: EBIT in the range of € 33 -35million