Meeting Kimia Farma – Biotest AG

.
Current situation
Future perspectives .
 Agenda

1. Introduction Giuliano Tagliabue

2. Biotest (CREAT) update
3. ICON new Organization
4. Blue Ocean Strategy & the Italian case for IgM
5. Opportunities for Cytotect & Hepatect
6. Fovepta update (Market launch & planned activities)
7. Forecast 2019
8. First input for budget 2020

ICON region - APAC 1

2
3
Agenda

Biotest (CREAT) update

ICON region - APAC 4

5
BPL

6
 26,7%
26,3%

RAAS
25,8%

BPL

7
Board of Directors

8
Board of Directors
from May 1st

9
10
11
12
 This is ICON

LATAM
APAC
North Europe

17.04.2019 Biotest AG and the ICON region

 Organizational Changes
country from to from to

Spain EASE ICON Gavilan Gavilan

Portugal
Turkey EASE EASE Cantore Morales

Latin ICON ICON Morales Gavilan

America
Israel EASE EASE Gavilan Cantore
Palestine
Russia ICON ICON Maeyama Morey

China ICON ICON Maeyama Rorarius

14
 ICON Head
G.Tagliabue

HBO APAC UK & PATCO SPA & LATAM

J.Hodkinson N.Rorarius P.Morey R.Gavilan

MKTG MNGR
C.Ungerer
UK SPA
Scient ADV
P.Griffith
Admin Specialist Russia
A.Meinelt L.Romer

BOM
tba

MSL
tba
15
 ICON PEOPLE

Current Vacancies Total

UK 12 12
Spain 5 2 7
HQ 5 2 7
Germany

ICON 22 4 26

16
 Sales 2018(euros)
160.000.000

140.000.000

120.000.000

100.000.000

80.000.000

60.000.000

40.000.000

20.000.000

0
EASE ICON CEU MEAF

17
 Sales 2018 - Budget 2019 (euros)
180.000.000

160.000.000
95,3 mio €
140.000.000

120.000.000

100.000.000

80.000.000

60.000.000

40.000.000

20.000.000

0
EASE ICON CEU MEAF

18
Agenda

Blue Ocean Strategy & the Italian case for Pentaglobin

11 - 12 Mar 2019 ICON region - LATAM 19

Source: Blue Ocean Strategy
(W.Chan / Renèe Mauborgne)

21
Red Ocean vs Blue Ocean

Red Ocean Strategy Blue Ocean Strategy

VS
Compete in existing market space Create uncontested market space

Beat the competition Make the competition irrelevant

Exploit existing demand Create and capture new demand

Make the value-cost trade-off Break the value-cost trade-off

Source: Blue Ocean Strategy

(W.Chan / Renèe Mauborgne)
The Impact of Creating a Blue Ocean

Business launch 86% 14%

Revenue Impact 62% 38%

Profit Impact 39% 61%

0% 20% 40% 60% 80% 100%

Launches within red oceans Launches for creating blue oceans
Source: Blue Ocean Strategy
(W.Chan / Renèe Mauborgne)
 Biotest Portfolio

Product Competitive Pressure

Pentaglobin None
Megalotect/Cytotect None Blue Ocean
Zutectra Low Products
Varitect None
Hepatect Medium
Intratect High
Red Ocean
Albiomin High
Products
Haemonine High
Haemoctin Very High

24
 The

Experience
(Toll Fractionation data)
IVIG MKT in Italy (tons)

0,5; 12%

1,2; 27%

2,7; 61%

IVIG TF IVIG Comm IVIG sc

26
 Biotest Portfolio

Product Competitive Pressure

Pentaglobin None
Megalotect/Cytotect None Blue Ocean
Zutectra Low Products
Varitect None
Hepatect Medium
Intratect High
Red Ocean
Albiomin High
Products
Haemonine High
Haemoctin Very High

27
Biotest – Portfolio

product Launch date

Cytotect 1983
Pentaglobin 1985
 Pentaglobin Sales Trend
(€.000)

Pentaglobin
7.000

6.000

5.000

4.000

3.000

2.000

1.000

0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017

Pentaglobin

29
 Pentaglobin/Cytotect Sales Trend
(€.000)

9.000
8.000
7.000
6.000
5.000
4.000
3.000
2.000
1.000
0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 Bdgt
2019

Cytotect Pentaglobin

30
 Pentaglobin/Cytotect Sales Trend
(€.000)

9.000
8.000
7.000
6.000
5.000
4.000
3.000
2.000
1.000
0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 Bdgt
2019

Cytotect Pentaglobin

31
Sales Force & MSL
2018 Performance Indicators

1.403 Physicians 4.839 rep calls

1.570 MSL calls

46 hospital meetings

32
 Pentaglobin/Cytotect Sales Trend
(€.000)

9.000
8.000 Gross Margin (2018)
7.000 • Pentaglobin in ITA 75%
• Cytotect in ITA 83%
6.000 • Intratect 10% in ICON 17%
5.000 • Intratect 5% in ICON 15%
4.000
3.000
2.000
1.000
0
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 2013 2014 2015 2016 2017 2018 Bdgt
2019

Cytotect Pentaglobin

33
Opportnities

• Cytotect
 Solid Organ (Spanish case)
 HSCT (French Case)
 Congenital CMV
 Cytotect Case: Spain/France off-label
€ (.000)
2500

2000

1500

1000

500

0
2013 2014 2015 2016 2017 2018

Spain France

35
 Cytotect Case: Spain/France off-label
€ (.000)
2500

2000 only in HSCT

1500
only in Lung

1000

500

0
2013 2014 2015 2016 2017 2018

Spain France

36
 Cytotect in Pregnancy
Prevention of maternal-fetal transmission of CMV by hyperimmunoglobulin
(HIG) administered after a primary maternal CMV infectionin early gestation.
Karl Oliver Kagan*; Martin Enders**; Matthias Stefan Schampera***; Elisabeth Baeumel***; Markus Hoopmann*;
Annegret Geipel****; Christoph Berg*****; Rangmar Goelz******; Luc De Catte*******; Diethelm Wallwiener*; Sara Brucker*,
Stuart P Adler********; Gerhard Jahn***; Klaus Hamprecht***

o Thus, 7.5% (3/40) of pregnant women with primary CMV

infection in the treatment group vs 35.2% (38/108) in the
control group transmitted CMV vertically to the foetus => very
good efficacy
o The administration of 2 ml/kg Cytotect to pregnant women
was safe, without serious problems in their cohort (although
the study was not powered to detect side effects)

37
Freedom in your hands
ADMINISTRATION ROUTES

Administration in Administration at Self

hospital assisted home but administration
- indipendence at+home
assisted
ZUTECTRA MARKET SHARE TREND

MS Zutectra (IM+SC)
60,0%
41,9% 45,1% 46,1%
40,0% 37,2% 38,5%
29,4% 33,3%
21,8%
20,0%
0,9%
0,0%
2010 2011 2012 2013 2014 2015 2016 2017 2018

LAUNCH
Dec 2010
Hepatect/Zutectra beyond Liver Tx

41
Immunoprophylaxis

Indication Label? Status Deliverable est.

Dialysis in label
Evaluation of Possibility to raise
Newborn prophylaxis in label market size and awareness and
PEP in special groups in label competitive promote
situation ongoing immediately
Vaccine non-responder in label
Use of HBV+ organs New indication Not started
HBV reactivation in New indication Not started
immunosuppressed patients

20 Feb 2019 GSMS 42

Beyond current indications – Role of HBsAg

HBsAg is associated with suppression of anti HBV immune functions

 HBsAg eradication enables recovery of the immune system

HBsAg is an independent risk factor for HCC

 HBsAg eradication reduces risk for HCC recurrence / development

HBsAg is required to form HDV virus particles

 HBsAg eradication limits HDV spread in the liver

20 Feb 2019 GSMS 43

 Supply Issues & Price

11 - 12 Mar 2019 ICON region - LATAM 44

 Price & Supply Issues

ICON Bdgt YTD Mar-19 Indonesia

Intratect 37,7 €/g 39,40 €/g 36€/g
(94,25€ = 50 ML) (98,50€ = 50 ML) (90,00€ = 50 ML)

Albiomin 2,06 €/g 2,24 €/g 2,15€/g

(20,60€ = 50ml) (22,40€ = 50 ML) (21,50€ = 50 ML)

11 - 12 Mar 2019 ICON region - LATAM 45

 Biotest Product Supply Update
Indonesia January February March April May June July August September October November December Total
Budget 2019 - - - - - - - 1.000 - - - 1.000 2.000
Kimia Farma FC - - - - - 1.000 - 1.000 - - 1.000 - 3.000
Haemoctin 250 IU
Biotest Supply (03/19) 1.000 1.000 1.000 3.000
Difference - - - - - - - - - - - - -
Budget 2019 3.000 - 4.500 - - 3.000 - - 3.500 - 2.500 16.500
Kimia Farma FC - 3.612 4.500 - 3.000 - - 3.500 - 2.500 17.112
Haemoctin 500 IU
Biotest Supply (03/19) 500 3.612 4.500 3.000 3.500 2.500 17.612
Difference 500 - - - - - - - - - - - 500
Budget 2019 1.000 - - - 1.500 - - 1.000 - 1.000 - 4.500
Kimia Farma FC - 1.000 1.500 1.500 1.000 1.000 6.000
Haemoctin 1000 IU
Biotest Supply (03/19) 1.000 1.500 1.500 1.000 1.000 6.000
Difference - - - - - 1.500 - 1.500 - - - - - -
Budget 2019 5.000 5.000 - 5.000 5.000 - - - 5.000 5.000 - 30.000
Kimia Farma FC 10.000 5.000 5.000 5.000 5.000 30.000
HA 50 ML
Biotest Supply (03/19) 10.000 5.000 5.000 5.000 25.000
Difference - - - - - 5.000 - - - - - - - - 5.000
Budget 2019 12.000 18.500 25.000 12.500 25.000 5.000 25.000 - 25.000 - 148.000
Kimia Farma FC 11.463 18.500 12.500 25.000 12.500 17.500 25.000 25.000 147.463
HA 100 ML
Biotest Supply (03/19) - 11.463 18.500 12.500 25.000 12.500 17.500 25.000 25.000 147.463
Difference - - - - - - - - - - - - -
Budget 2019 1.250 - 1.250 - - 1.250 - - 1.250 - 1.250 6.250
Kimia Farma FC 1.250 1.850 1.850 1.250 6.200
Intratect 50 ML
Biotest Supply (03/19) 4 1.250 1.850 1.850 1.250 6.204
Difference 4 - - - - - - - - - - 4
Budget 2019 250 - 750 250 250 250 250 250 500 250 3.000
Kimia Farma FC 500 500
Pentaglobin 10 ML
Biotest Supply (03/19) 420 250 250 250 250 250 500 250 2.420
Difference - - - - 420 250 250 250 250 250 - 250 1.920
Budget 2019 2.000 - 2.000 - 2.000 - 2.000 - 2.000 - 2.000 - 12.000
Kimia Farma FC - - - - - - - - - - - - -
Fovepta
Biotest Supply (03/19) 2.000 - 2.000 - 2.000 - 2.000 - 2.000 - 2.000 - 6.000
Difference 2.000 - 2.000 - 2.000 - 2.000 - 2.000 - 2.000 - 6.000

Niklas Rorarius APAC & China 46

Fovepta Market Update

Niklas Rorarius APAC & China 47

Fovepta Market Launch

• New product materials

• Planned activities Roadshows

• Launch symposia

Niklas Rorarius APAC & China 48

Fovepta Market Launch

• New product materials

Niklas Rorarius APAC & China 49

Fovepta Market Launch

• Planned activities Roadshows

Niklas Rorarius APAC & China 50

Fovepta Market Launch

• Launch symposia:

10th Annual Scientific Meeting of Indonesian Pediatric Society and 15th Congress of
Asian Society for Pediatric Society in 7-11th of September 2019 in Manado, Indonesia.

 Lunch Symposium on Monday the 9th of September on Fovepta.

 Speakers: Dr Hanifah Oswari (genereal lecture on HBV and newborns and
the importance of vaccination)
 Peter Griffith’s Fovepta medical presentation

 Silver Sponsor total 400.000.000 IDR (= 25.000€)

 Biotest to cover 250.000.000 IDR (=15.500€)
 Kimia Farma would cover 150.000.000 IDR

Silver Sponsor would allow us to organize one Lunch Symposium and

Standard Booth at Exhibition gallery.
Niklas Rorarius APAC & China 51
Pentaglobin

• Materials

• Training (videos)

• Congresses and Hospital meetings (RTC)

• Asia Pacific Expert meeting in neonatal and pediatric sepsis (June 30, 2019 in Bali)

Niklas Rorarius APAC & China 52

Pentaglobin

• Materials to be sent in English (PICU/NICU)

Niklas Rorarius APAC & China 53

Pentaglobin

• Training (videos)

Niklas Rorarius APAC & China 54

Pentaglobin

 Hospital meetings (RTC)

 11th Indonesian PICU NICU meeting 28-29th of June 2019.

 Lunch Symposium on Saturday 29th of June between 11:20 and 11:50. The
topic: The Use of IgM-Enriched Intravenous Immunoglobulin Therapy for
Neonatal Sepsis. Speaker: Prof. Rohsiswatmo (CIPTO Jakarta) & Prof Frey or
Prof. Ener.
 The Lunch Symposium and Standard Booth with estimated costs are 6.660,00
USD.

 Asia Pacific Expert Meeting in Neonatal/Pediatric Sepsis on 30th of June.

 To invite 4-5 Indonesian KOLs to attend the Advisory Board but not more than 2
presentations

Niklas Rorarius APAC & China 55

New opportunities with Cytotect and Hepatect

• Cytotect:
 Asia Pacific Expert meeting in Cytomegalovirus in Bone Marrow Transplantation
(January 12, 2019 in Singapore)
 Dr. Santosa (Semarang)

• Hepatect:
 Dr. Hanifah Oswari was mentioning that there are some supply issues with
current HBIG products.
 SAS permit as we don’t have any supply issues with Hepatect.

 We can offer it in 10 ML (=500 IU), 40 ML (=2000 IU) and 100 ML (=5000 IU)
bottle sizes.

Niklas Rorarius APAC & China 56

Cytotect and Hepatect

• Materials to be sent in English

Niklas Rorarius APAC & China 57

Outstanding payments

Positon #1: The remaining payment due is 272.300€ and not 316.050€

John Hodkinson ICON 58

Change of payment terms

• Mini DD sent to Kimia Farma

• Proposal from Biotest to change from proforma (cash in advance) payments to 60

day payment terms

• After Biotest receives from the following documents we can apply for the change of
payment terms:

1. Simplified_COMPANY DUE DILIGENCE QUESTIONNAIRE

2. Code of Conduct
3. A copy or an extract on Kimia from the commercial or company’s register or, if
possible, another official register or record in which the shareholding in Kimia is
documented,
4. Passport copy of the individual representing Kimia towards Biotest

Niklas Rorarius APAC & China 59

60