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Biotest AG — Investor Presentation 2018
Mar 28, 2019
66_rns_2019-03-28_838abc99-4b31-41a9-926d-e00805db0a81.pdf
Investor Presentation
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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, 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 2018 at a glance
- •Guidance 2018 achieved
- • Sales of Continuing Operations in FY 2018 at €400.3 m vs. €378.1 m in FY 2017
- • EBIT in FY 2018 at €10.6 m vs. €-9.3 m in FY 2017
- • 31 Jan 2018: takeover of 89,88% of Biotest AG's ordinary shares and voting share capital by Creat
- • Divestiture of all Biotest's US companies incl. all plasma collection centers in US to Grifols; sales proceeds of USD 286 m
- • Opening of two new plasma collection centres in Czech Republic; Total number to date 20
- •Biotest Next Level project progressing
Takeover by Creat and next steps
Takeover by Creat
- • Takeover of 89,88% of Biotest AGs ordinary shares and voting share capital by Creat was closed on 31 Jan, 2018
- • Tiancheng (Germany) Pharmaceutical Holdings AG, announced to investigate to enter into a domination & profit and loss transfer agreement with Biotest AG on8 Feb, 2018
- • Shanghai RAAS has publicly announced to initiate a capital increase against cash and contribution in kind. Creat intents to contribute Tiancheng as contribution in kind.
Income statement(€ million)
| 2 0 1 7 |
2 0 1 8 |
|
|---|---|---|
| S l a e s |
3 7 8 1 |
4 0 0 3 |
| O i & t t p e r a n g c o s s e x p e n s e s |
3 8 7 4 |
3 8 9 7 |
| O i P f i ( E B I T ) t t p e r a n g r o |
9 3 - |
1 0 6 |
| F i i l l i f j i t, t t t n a n c a r e s a e s n c o m e r o m o n e n r e s u x v u , |
7 1 - |
2 3 5 - |
| E i f ( E A T ) f C i i t t t a r n n g s a e r a r o m o n n n g x u O i t p e r a o n s |
6 1 4 - |
2 9 1 - |
| E i f ( E A T ) f D i i d t t t a r n n g s a e r a x r o m s c o n n u e O i t p e r a o n s |
1 2 9 |
1 9 4 6 |
| G E i f ( E A T ) B i t t t t a r n n g s a e r a x o e s r o u p |
3 5 - |
1 8 1 7 |
EBIT regular and adjusted(€ million)
| 2 0 1 7 |
2 0 1 8 |
|
|---|---|---|
| E B I T d t r e p o r e |
9 3 - |
0 6 1 |
| B i N L l * t t t t o e s e x e v e c o s s |
5 3 9 |
5 3 4 |
| M l l i b d i t o n o c o n a a n o e s |
7 6 |
3 9 |
| E B I T d j d t a u s e |
2 2 5 |
6 9 7 |
*: including R&D costs for BNL development drugs
Sales development
(€ million)
- • All four sales regions show single digit growth rates; East & South Europe +9.2%;Central Europe: +9.1%
- • Main reasons for positivedevelopment were increase of Albumin salesto regular level and increased Intratect sales
Balance sheet (Continuing + Discontinued Operations)(€ million)
Cash flow from Continuing Operating activities 2018(€ million)
Product supply chain process and timing
Product and supply chain process at a glance
Over all processing time: 7-8 months
Cash flow: △ working capital (€ million)
| I i t △ n v e n o r e s |
6 1 4 - |
|---|---|
| R i b l d h t t △ e c e a e s a n o e r a s s e s v |
2 9 3 - |
| T d b l d h b l t △ r a e p a y a e s a n o e r p a y a e s |
1 2 0 |
| O h i i t △ e r p r o v s o n s |
0 8 - |
| W k i i l t △ o r n g c a p a = |
7 9 5 - |
Development of financial liabilities
(€ million)
Dividend Proposal to Annual General Shareholder Meeting
Dividends for 2018
to be proposed to the Annual General Meeting on 7 May 2019:
- •€0.00 per ordinary share
- •€0.04 per preference share
Dividend amount remains constant to finance future growth
Guidance 2019
Sales: In 2019 sales of continuing operations will increase by a mid-single-digit percentage
- EBIT: Earnings will be influenced by various factors in 2019:
-
- Mainly further expenses as part of BNL expansion project of €80 to 90 million (incl. associated BNL R&D costs)
- Tense situation in the crisis regions, particularly in the Middle East
- -A partner is being sought for advanced development projects
EBIT of continuing operations will be between €-5 million and €+5 million,if partnering can be successfully concluded in 2019
Global IgG (i.v. + s.c.) market size development(Volume in tons)
- •The global IgG Market reached a size of nearly ~188 tons in 2017e
- •In the period 2009 to 2017, the total market grew by ~9% annually (CAGR)
Sources: Biotest Market and Pricing Insights based on MRB (2014, 2016), PPTA (2017), Markets and Markets (2017)
IgG usage per capita 2017Consumption
*IVIG usage per capita 2015
Source: IMS Midas (2017), PPTA (until Nov. 2017 for EU and Sep 2017 for US distribution data), MRB (2014, 2015, 2016), NBA Australia 2017, CIA Factbook, except *: populationpyramid.net
Product portfolio Biotest today / tomorrow
| T d o a y |
T o m o r r o w |
||
|---|---|---|---|
| P l l I G t o y v a e n g In 5 % tra te t c In 1 0 % tra te t c |
+ | G P l l I t o y v a e n g G Ge Ig Ne t x n |
|
| H I G / S i l d t t y p e r g p e c a y p r o u c s – He ( He B ) te t p a c p Zu ( He B ) te tra c p Fo ( He B ) ta ve p p Cy Cy ( l ie ) to te t to c me g a Va i ( Va ize l la- Zo ) te t te r c r s r |
|||
| S i l d t t p e c a y p r o u c s G Pe lo b in ( Ig M ic he d Ig ) ta n g en r B ise ko |
+ | S i l d t t p e c a y p r o u c s Tr im du l in ( Ig M ic he d Ig G ) o en r |
|
| H h i l i a e m o p a Ha in ( F V I I I ) t em oc Ha ine ( F I X ) em on |
+ | F i b i r n o g e n Ac ire d F i br ino de f. q u g en Co i l F i br ion de f. ta ng en og en |
|
| H A l b i u m a n u m n A l b iom in 5 % A l b iom in 2 0 % |
Biotest portfolio differentiation(€ million)
Biotest has unique specialityproducts in it´s portfolio:
- Cytotect
- Varitect
- Hepatect
- Zutectra
- Pentaglobin (IgM product)
- Biseko
- Speciality portfolio showgood growth rates
Cytotect® CP
Published data from France highlight the benefit of Cytotect ® CP for treatment of CMV in hematopoietic stem cell transplantation patients
Targeted mode of action:
Neutralisation of free virus particles
Opsonisation of virus
- Specific activation of the cellular immune system
- Immune modulation
Cytotect® CP reduces Cytomegalievirus infections, prolongs survival and helps prevent organ rejection*
*: Alsuliman et al. "Cytotect(R) CP as salvage therapy in patients with CMV infection following allogeneic hematopoietic cell transplantation: a multicenter retrospectivestudy". Bone Marrow Transplant (2018)
Anti-counterfeiting of pharmaceuticals in the EU
- Falsified products (e.g. wrong quantity/ quality of active substance) are a serious threat to safety of patients
- Protection of health of patients important
Serialization: assignment of unique, traceable numbers to individual items or saleable units
Expansion of plasma donation centres
- • Two new centres in Czech Republic(Břeclav, Brno) in 2018
- • One new centre in Germany (Hanover) in 2019
New plasma donation centre in Brno
Biotest plasma donation centres
Research & development projects to market
| T d o a y |
2 0 2 1 |
2 0 2 1 > |
|---|---|---|
| B N L d t p r o u c • d l t e v e o p m e n L i f l e c c e y • t m a n a g e m e n j t p r o e c s |
I G N G i t t g e e n e r a o n x • P I D − I T P * − A l b i i o m n • H i t a e m o c n • |
I G N G i t t g e x e n e r a o n • S b ( S C ) 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 u • F i b i • |
| r n o g e n i l t c o n g e n a − i d a c q r e u − |
• Haemophilia ATherapeutic
*: Primary Immune Deficiency; **: Idiopathic Thrombocytopenic Purpura; ***: Chronic Inflammatory Demyelinating Polyneuropathy, or other neurological indication
IgG Next Generation (IVIG)
- •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; study 991): enrollment completed
- •Phase III study in ITP** (EU; study 992): study completed
- •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
Building on the Intratect experience to create an optimized IVIG -IgG Next Generation
Maintain:
- No thrombogenic activity
- High margins of safety for prions and viruses
Further improve:
- Implementation of an additional purification column to further reduce anti-A/anti-B antibody levels
- Increased immunoglobulin yield to 4.5 g/l plasma
Trimodulin - IgM-enriched ImmunoglobulinBroad therapeutic potential in severe infection
i.e. K. pneumoniae, P. mirabilis,P. aeruginosa, E. sakazakii, Enterococcus sp., Staph. aureus, C. difficile, C. jejuni, C.albicans, E. coli, P. aeruginosa, S. marcescens, Enterobacter sakazakii
- •Neutralization of multiple pathogens
- • Binding of toxins and inflammation activators
- • Reducing the secretion of immune mediators
- •Immune modulation
Trimodulin for treatment of severe community acquired pneumonia (sCAP)
No comparable adjuvant therapy available
- •Neutralization of bacterial toxins
- •Reduction of overshooting immune-mediated tissue damage
- • Reduced risk for severe sepsis, septic shock, respiratory and multiorgan failure
Fibrinogen
Indication:
Congenital fibrinogen deficiency and acquired fibrinogen deficiency in the indication severe spinal surgery
Status:
- • Congenital Fibrinogen deficiency trail in phase I/III
- • Acquired Fibrinogen deficiencyin phase III
Source: IMS Data 2-2017, Internal Critical bleeding market research, Data provided by affiliate
Fibrinogen - Point of care diagnostic
- • In Germany and Austria the market growth was highly connected with improved diagnostics
- • ROTEM®/TEG® devices are established for point-of-care diagnosis and treatment
- • Especially important for acquired fibrinogen deficiency,
- • to monitor decrease of fibrinogen levels during bleeding=> triggered treatment decision
- • to adjust dosing according to individual need=> targeted dosing
Strategic pillars of BNL development program
- •Globalization of products
- •More products out of one litre plasma
- •Specialty plasma products (high medical need)
| T d o a y |
F V I I I |
A l b i u m n |
I G g |
|||
|---|---|---|---|---|---|---|
| B N L |
F V I I I |
A l b i m n u |
G I g |
T i d l i r m o n u |
F i b i r n o g e n |
Biotest Next Level – successful IgG purificationMilestones 2018
- • Equipment for purification step of IgG Next Gen passed qualified and ownership transferred to Biotest
- • Operational qualification of major equipment completed and final validation stages for IgG Next Gen have been started
- • Clean rooms and media preparation will be inspected by authority end of 2019
Next Steps
- •Biotest Next Level progressing
- • Clinical trials for new BNL products ongoing: IgG Next Gen, Fibrinogen; Trimodulin in preparation
- •Opening of new plasma collection centres in Europe