Miltenyi Biotec in Asia Pacific

Miltenyi Biotec in Asia Pacific Regional diversity, opportunities & challenges Dr. Boris Stoffel 4th Life Science Conference, 17th May 2011, Frankfurt

IN OR OUT? Sculpture Park Cologne Garden Gallery, Exhibition Köln Skulptur #6 Sou Fujimoto, 2011

Key facts Miltenyi Biotec Germany s largest independent, privately owned Biotech Company Founded in 1989 by Dipl. Phys. Stefan Miltenyi, President / CEO More than 1200 employees in 18 countries More than 300 employees in R&D reagents, engineering & clinical development Profitable since inception; revenues 2010 > 170 Mio US$

Number of employees 1989-2010 1400 1200 1200 1000 800 600 400 200 0 Year 203 101 3 1989 1995 2000 2010 75% in Germany 25% Subsidaries but only 15% of global revenues are generated in the DACh sales region!

Mission Miltenyi Biotec is committed to advancing scientific understanding and medicine by providing tools for biomedical research and cellular therapy.

Miltenyi Biotec portfolio management

Core technology MACS separation principle Magnetic labeling Magnetic separation Positively selected fraction

Technologies MACS Columns and Separators MACS Column in strong permanent magnet Gentle to cells Thorough rinsing procedure Convenient for working under sterile conditions Straightforward to automate Spherical steel matrix in column induces high-gradient magnetic field High-gradient magnetic field efficiently retains magnetically labeled cells in column

Miltenyi Biotec portfolio management

Adding value to the workflow Sample Preparation gentlemacs tubes & MACSmix Tube Rotator OctoMACS Starting Kit Cell Separation Cell Culture MACS Media & Cytokines MACS Reagents Cellular Analysis Biomolecule Separation mrna isolation Kit Genomic Services Molecular Analysis KIR Typing Kit

Research instrument portfolio: Ease of use Miltenyi Biotec s research instrument portfolio serves hundreds of applications automacs Pro Separator Sample Preparation Cell Separation gentlemacs Dissociator MultiMACS Cell24 Separator Cell Culture MACSQuant Analyzer Cell Analysis Bio-molecule Separation Molecular Analysis MultiMACS M96 (thermo) Separator

The translational approach Where cells replace or support drug regiments: from bench to bedside Cryopreservation Cell Material Cell selection Cell expansion or differentiation Quality control Administration to patient Donor / patient

The translational approach CryoMACS Freezing Bags CliniMACS Reagents MACS GMP Cytokines MACS GMP Media Cryopreservation Cell Material Cell selection Cell expansion or differentiation Quality control Administration to patient Cell culture bags Donor / patient Cell differentiation bags

New benchmark in cellular therapy = + + + + + +

New benchmark in cellular therapy = + + + + + + CliniMACS Prodigy

Use of the CliniMACS System Hematology / Graft engineering (blood & marrow transplantation) Adoptive immunotherapy Regulatory T cell therapy Dendritic cell therapy Regenerative medicine (heart, liver, bone, nervous system, )

Miltenyi-sponsored Phase III trial PERFECT Intramyocardial injection of BM-derived CD133 + stem cells during bypass surgery

CD133 + stem cells for liver regeneration Randomized, controlled, prospective, multicenter approval trial Test balloon for de-centralized cell manufacturing in EU

How do the first results look? 16 14 Daily Growth Rate (ml) 12 10 8 6 4 2 0 Control CD133 Days to Surgery 70 60 50 40 30 20 10 Patients grow their liver faster 0 Control CD133 Patients get surgery faster

Inception Miltenyi Biotec subsidiaries 1989-2012 1989 1992 1996 1998 2003 2003 / 2004 2008 2011/2012 Miltenyi Biotec Miltenyi Biotec Miltenyi Biotec Miltenyi Biotec Miltenyi Biotec Miltenyi Biotec Miltenyi Biotec Miltenyi Biotec Germany US UK France, Italy & Regulatory Affairs Australia, Japan China China Spain Boston, US Singapore Rep. Offices Trading Shanghai company Beijing

Asia Pacific employee development 2008-2011 Singapore distributor network covering India Pakistan Bangladesh Thailand Malaysia Indonesia Taiwan Korea Employees 2008 2009 2010 2011 MB Australia 6 6 7 9 MB China 10 11 12 13 MB Japan 24 25 29 31 MB Singapore 10 11 9 11

Asia Pacific Overall Sales 2008 2010 vs. US EU RoW Annual average growth 2008-2010 Europe 12% Asia Pacific 15% USA 10% RoW 20%

Asia Pacific Overall Subsidiary Sales 2008 2010 Annual average growth 2008-2010 Australia 20% Japan 12% Singapore 19% China 20%

Asia Pacific Region Research Sales 2008 2010 vs. US EU RoW Annual average growth 2008-2010 Europe 15% Asia Pacific 14% USA 9% RoW 26%

Asia Pacific Subsidiary Research Sales 2008 2010 Annual average growth 2008-2010 Australia 22% Japan 11% Singapore 17% China 23%

Asia Pacific Region Clinical Sales 2008 2010 vs. US EU RoW Annual average growth 2008-2010 Europe 5% Asia Pacific 26% USA 20% RoW 16%

Asia Pacific Subsidiary Clinical Sales 2008 2010 Annual average growth 2008-2010 Australia 9% Japan 186% Singapore 136% China 22%

Miltenyi Biotec Australia Miltenyi Biotec Australia Pty. Ltd. Inception 2003 Office 1 / Sydney Employee increase since inception + 50% Contribution to MB group revenue (2010) 2% Contribution to APAC revenue (2010) 14% Average growth 2006-2010 12% Clinical / Research split 7 / 93 Review. Challenges. Opportunities Funding situation unstable Cellular therapies: new strategic focus Past focus towards US and Europe, now more networking in APAC Hugh geography to be covered Growth in % +29% 2010 +17% 2009 +14% 2008 +8% 2007-7% 2006

Miltenyi Biotec Singapore / Asia Pacific Miltenyi Biotec Asia Pacific Pte Ltd. Inception 2003 Office 1 / Singapore Employee increase since inception + 10% Contribution to MB group revenue (2010) 4% Contribution to APAC revenue (2010) 23% Average growth 2006-2010 20% Clinical / Research split 17 / 83 Growth in % +8% 2010 Review. Challenges. Opportunities Increasing cost of living Increasing cost of labour Increasing cost of rent Recruitment of skillful people extremely difficult Too far away from major APAC markets +19% 2009 +28% 2008 +14% 2007 +32% 2006

Miltenyi Biotec Japan Miltenyi Biotec K.K. Inception 2003 Office 1 - Tokyo Employee increase since inception + 30% Contribution to MB group revenue (2010) 8% Contribution to APAC revenue (2010) 52% Growth in % Average growth 2006-2010 14% Clinical / Research split 7 / 93 +15% 2010 Review. Challenges. Opportunities 2008/2009 change in management 2010 MB KK. Japan number one Life Science company in Japan Strong team of dedicated people of the younger generation High quality products extremely valued in Japan (Made in Germany) Excellent market knowledge Outstanding technical support +18% 2009 +1% 2008 +6% 2007 +28% 2006

Miltenyi Biotec China Miltenyi Biotec China Shanghai / Beijing Inception 2008 Rep. offices 1 - Shanghai, 1 - Beijing Employee increase since inception + 100 % Contribution to MB group revenue (2010) 2% Contribution to APAC revenue (2010) 11% Average growth 2006-2010 14% Growth in % Clinical / Research split 20 / 80 +21% 2010 Review. Challenges. Opportunities 2008 we changed our management Cultural challenges language, trust, metality, intransparency Increasing labour cost / compensation packages Complexity in clinical regulatory affairs Supplement international management & experts to support market development 2011 trading company to penetrate market with distributor network and direct sales +33% 2009 +7% 2008-1% 2007 12% 2006 Analyze partnering opportunities for production Create products especially for the chinese market

In or out? Sculpture Park Cologne Garden Gallery, Exhibition Köln Skulptur #6 Sou Fujimoto, 2011

Miltenyi Biotec China Miltenyi Biotec China Shanghai / Beijing Inception 2008 Rep. offices Employee increase since inception + 100 % Contribution to MB group revenue (2010) 2% Contribution to APAC revenue (2010) 11% Average growth 2006-2010 14% Clinical / Research split 20 / 80 Review. Challenges. Opportunities 2008 management change 1 - Shanghai, 1 - Beijing Increasing labour cost / compensation packages Language barríer Scarcity of experts for HR recruitment Market penetration with diverse product portfolios Representative office status preventing direct sales approaches. Required to act legally as a sales organisation in China Clinical regulatory affair complexity 5 year planning for instrument investments Growth in % +21% 2010 +33% 2009 +7% 2008-1% 2007 12% 2006 Tie up competitive HR packages, compensation Supplement international management & experts to support Chinese staff Switch Representative office to a legal entity / trading company to penetrate the Chinese market with distributor network and direct sales Strategic repositioning of office location in China

Miltenyi Biotec Singapore / Asia Pacific Miltenyi Biotec Asia Pacific Pte Ltd. Inception 2003 Office 1 / Singapore Employee increase since inception + 50% Contribution to MB group revenue (2010) 3% Contribution to APAC revenue (2010) 23% Average growth 2006-2010 20% Clinical / Research split 17 / 83 Review. Challenges. Opportunities Growth in % +8% 2010 +19% 2009 +28% 2008 +14% 2007 +32% 2006

Miltenyi Biotec Australia Miltenyi Biotec Australia Pty. Ltd. Inception 2003 Office 1 / Sydney Employee increase since inception + 50% Contribution to MB group revenue (2010) 2% Contribution to APAC revenue (2010) 14% Average growth 2006-2010 12% Clinical / Research split 7 / 93 Review. Challenges. Opportunities Growth in % +29% 2010 +17% 2009 +14% 2008 +8% 2007-7% 2006

Miltenyi Biotec Japan Miltenyi Biotec K.K. Inception 2003 Office 1 - Tokyo Employee increase since inception + 30% Contribution to MB group revenue (2010) 8% Contribution to APAC revenue (2010) 52% Average growth 2006-2010 12% Clinical / Research split 7 / 93 Review. Challenges. Opportunities 2008/2009 change in Management 2011 Miltenyi Biotec Japan number one Life Science company in Japan Growth in % +15% 2010 +18% 2009 +1% 2008 +6% 2007 +28% 2006

Miltenyi Biotec Asia Pacific Region Miltenyi Biotec APAC region Inception 2003-2008 Offices Employee increase since inception + 20% Contribution to MB group revenue (2010) 15% Average growth 2006-2010 13% Clinical / Research split 20 / 80 Challenges & Opportunities 1 - Shanghai, 1 - Beijing 1 - Singapore 1 - Tokyo 1 - Sydney Future growth and expansion can only be realised by setting the right Management structure and functions. Dedicated experts for the specific region are key to drive strategic and operative changes within the APAC region. Close mentorship by Headquartermanagement has to be accepted and lived in the entire organisation. It is all about people management and the right management mix. Headquarter globally is taking part in exchange programs between subsidiaries to mutually prepare management to fit the geographical needs. Due to Miltenyi s large and diverse product portfolio, experts with indepth market knowledge combined with the right touch for regional specific business models and opportunities are needed. Central logistical hub in the APAC region to overcome constant delivery bottlenecks Strategic repositioning of office location in China

Global Marketing teams and Global employee exchange programs to fit global needs United Kingdom Switzerland USA Turkey Vietnam Malaysia US / Canada Europe EX Europe Asia Pacific RoW

CryoMACS 2010 vs Baxter Cryocyte sales CryoMACS Freezing Bags