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Biotest AG — Investor Presentation 2018
Mar 22, 2018
66_rns_2018-03-22_afc4a396-3b34-49fa-ba7b-19a23396526a.pdf
Investor Presentation
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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 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 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.
Biotest Group: FY 2017 at a glance
- •Guidance 2017 achieved
- • Successful takeover by 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 BPC ADMA Biologics Inc., USA in June 2017
- •Biotest Next Level project progressing
Re-alignment of Biotest Group´s global business
Expansion of plasma donation centres
- • 3 new centre in Hungary (Székesfehérvár, Debrecen, Kaposvár)
- • 2 new centre in Czech Republic (Prague, B řeclav (Jan 2018))
| P l a s m a d t i o n a o n |
1 9 t c e n r e s |
9 G E R |
|
|---|---|---|---|
| t c e n r e s |
8 H U |
||
| 2 C Z |
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 into 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
NorthAmerica South America Europe Middle East APAC RoW
- • Biotest's sales are focused on Europe and the Middle East Biotest sfocused 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.
China is the blue Sea of the international plasma products industry
- • In 2015, the scale of the Chinese domestic plasma product market is approx. USD 2.51 billion
- • The Chinese plasma product market is still in its early stage, and with the development of the consistent market enhancement, the future growth potentials are huge
Average consumption of immunoglobulin Gram/1000 person/year, estimation of 2016
Chinese economy and Average consumption of coagulation factors IU/ / ti ti f 2014/15 IU/person/year, estimation of 2014/15
Source: Biotest Market Research basedon IMS Midas (2016), PPTA (2016), MRB (2013, 2014, 2015, 2016, 2017), WFH (2016) , CIA Factbook
Financials FY 2017
Continuing vs. Discontinued Operations (€ million)
Income statement(€ million)
| 2 0 1 6 |
2 0 1 7 |
|
|---|---|---|
| S S l l a e s |
4 4 0 0 8 8. 0 0 |
3 3 7 7 8 8. 1 1 |
| O t i t & p e r a n g c o s s e x p e n s e s |
3 7 2 8 - |
3 8 7. 4 - |
| O f ( ) t i i t E B I T p e r a n g p r o |
3 5. 2 |
9. 3 - |
| F i i l l t, t i f j i t t n a n c a r e s u a x e s, n c o m e r o m o n v e n u r e s |
2 9. 1 - |
7. 1 - |
| E i f ( E A T ) f C i i O i t t t t a r n n g s a e r a x r o m o n n u n g p e r a o n s |
6. 1 |
1 6. 4 - |
| f ( ) f O E i t t E A T D i t i d t i a r n n g s a e r a x r o m s c o n n u e p e r a o n s |
5 1. 8 - |
1 2 9 |
| E i f ( E A T ) B i G t t t t a r n n g s a e r a x o e s r o u p |
4 5. 7 - |
3. 5 - |
EBIT regular and adjusted (Continuing Operations) (€ million)
| 2 0 1 6 |
2 0 1 7 |
|
|---|---|---|
| E B I T l r e g a r u |
3 5 2 |
9 3 - |
| B i N L l * t t t t o e s e x e v e c o s s |
3 8 7 |
3 9 5 |
| M l l t i b d i o n o c o n a a n o e s |
1 1 2 |
6 7 |
| ** H l b i l l u m a n a u m n r e c a |
2 2 9 |
|
| S ( C ) t t i l i t t r a e g c r e a g n m e n r e a |
1 1 5 |
|
| E B I T d j d t a u s e |
8 4 2 |
8 6 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
Sales development (Continuing Operations) (€ million)
- • Slight increase in Rest of Europe (+2.3%) due to increasing Pentaglobin sales
- • Albumin recall and shift of tender orders affected sales in all other regions
Balance sheet (Continuing + Discontinued Operations) (€ million)
Cash flow from Continuing Operating activities 2017 (€ million)
Guidance 2018
- Sales: In 2018 sales of Continuing Operations will increase by a mid-single-digit percentage
- EBIT: E i ill b i fl d b i f i 2018 Earnings will be influenced by various factors in 2018:
-
- Mainly further increased expenses as part of BNL expansion project of €60 to 70 million (incl. associated research and development costs )
- ¾EBIT of Continuing Operations will be in the range of €10 to 12 million
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 l Additional prod t f lit f ducts from every litre o Plasma
- • Capitalise on new product opportunities with strong in new in-house R&D capabilities house
- Focus on IgG Next Gen, Fibrinogen, Trimodulin (IgM Con.)
- •Analyse and implement potential synergies with BPL and Shanghai RAAS
Research & development projects to market
| T d o a y |
2 0 2 1 |
2 0 2 1 > |
|---|---|---|
| B N L d t ƒ p r o u c d l t e e o p m e n v L i f l e c c e ƒ y t m a n a g e m e n j t p r o e c s |
G G G G I I N N t t i i g e x e n e r a o n ƒ P I D • I T P * • A l b i i ƒ o m n |
G G I N t t i g e x e n e r a o n ƒ S ( S C ) b t u c u a n e o u s • C I D P * • T i d l i ( I M C ) r m o n g o n ƒ u |
| H i t ƒ a e m o c n |
F i b i r n o g e n ƒ i t l c o n g e n a • i d a c q r e u • |
|
| H h i l i A ƒ a e m o p a |
*: Primary Immune Deficiency; **: Idiopathic Thrombocytopenic Purpura; ***: Chronic Inflammatory Demyelinating Polyneuropathy, or other neurological indication
Therapeutic
IgG 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
- • 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
Fibrinogen: development for congenital fibrinogen deficiencies
- •Fibrinogen plays an essential role in blood clotting
- •A sufficient plasma fibrinogen level is critical for effective haemostasis
Fibrinogen: 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 under goin g major s pine sur gery g g j p gyassociated 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
Trimodulin (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 g positive feedback on clinical pro gramme
- •Only minor adaptations needed
- •Study protocol in finalisation
- •First steps with CRO were taken were
Communication with experts and scientific advices lead to a clear development path for the project
Overview monoclonal antibodies
Biotest develops the monoclonal antibodies until next milestones (finalization of clinical studies) have been completed
Next steps: divestiture or spin-out Nextspin out
Biotest Next Level
Biotest Next Level
Biotest Next Level – successful GMP*- inspection Milestones 2017
June
• N BNL B ildi i B ildi New uilding receives uilding approval and is released for commercial use
August
- • Successful GMP GMP*- inspection by the competent authorities (Regierungspräsidium Darmstadt)
- • Laboratories start with their dail y routines
GMP*= Good manufacturing practice
Biotest 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 Back February
Biotest Next Level – qualification process ongoing March 2018
- • All technical installations (power, heating air heating, air-conditioning water/ conditioning, 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
Summary
Next Steps
- •Closing of BPC divestiture
- •Analyse and implement potential synergies with BPL and Shanghai RAAS
- •Biotest Next Level pg g ro ressing
- • Clinical trials for new BNL products ongoing: IgG Next Gen, Fibrinogen; Trimodulin in preparation
- •Opening of new plasma collection centres in Europe