PowerPoint 2000 Presentation - Merck KGaA
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PowerPoint 2000 Presentation - Merck KGaA
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4 th<br />
Quarter and Full Year 2009 Results<br />
Dr. Karl-Ludwig Kley – General Partner and Chairman of the Executive Board<br />
Dr. Michael Becker – General Partner and Member of the Executive Board, Chief Financial Officer<br />
Elmar Schnee – General Partner and Member of the Executive Board, Head of Pharmaceuticals<br />
Dr. Bernd Reckmann – General Partner and Member of the Executive Board, Head of Chemicals<br />
February 23, 2010
Disclaimer<br />
Remarks<br />
All comparative figures relate to the corresponding last year’s period. From 2007 the Generics business is reported in<br />
“discontinued operations”. Return on Sales (ROS) calculation is based on total revenues.<br />
Important Information<br />
This presentation does not constitute an offer of securities for sale or a solicitation of an offer to purchase securities in the<br />
United States. The shares referred to herein have not been and will not be registered under the U.S. Securities Act of<br />
1933, as amended (the “Securities Act”), and may not be offered or sold in the United States absent registration under the<br />
Securities Act or an available exemption from such registration.<br />
Note regarding forward-looking statements<br />
The information in this document may contain “forward-looking statements.” Forward-looking statements may be identified<br />
by words such as “expects”, “anticipates”, “intends”, “plans”, “believes”, “seeks”, “estimates”, “will” or words of similar<br />
meaning and include, but are not limited to, statements about the expected future business of <strong>Merck</strong> <strong>KGaA</strong> resulting from<br />
the proposed transaction. These statements are based on the current expectations of management of <strong>Merck</strong> <strong>KGaA</strong> and<br />
E. <strong>Merck</strong> KG, and are inherently subject to uncertainties and changes in circumstances. Among the factors that could<br />
cause actual results to differ materially from those described in the forward-looking statements are factors relating to<br />
satisfaction of the conditions to the proposed transaction, and changes in global, political, economic, business,<br />
competitive, market and regulatory forces. <strong>Merck</strong> <strong>KGaA</strong> and E. <strong>Merck</strong> KG do not undertake any obligation to update the<br />
content of this presentation and forward-looking statements to reflect actual results, or any change in events, conditions,<br />
assumptions or other factors.<br />
Page 2
Table Of Contents<br />
Analyst’s <strong>Presentation</strong> February 23, 2010<br />
1<br />
2<br />
3<br />
4<br />
Executive Summary and Business Strategies –<br />
Financials<br />
–<br />
Michael Becker<br />
Developments Pharmaceuticals –<br />
Developments Chemicals –<br />
5 Appendix A - F from Page 35<br />
Elmar<br />
Schnee<br />
Bernd Reckmann<br />
Karl-Ludwig Kley<br />
Page 3
<strong>Merck</strong> Group<br />
FY 2009 at a Glance<br />
Development Total Revenues and Core Operating Result 2005 – 2009<br />
€m<br />
10,000<br />
8,000<br />
6,000<br />
4,000<br />
2,000<br />
0<br />
Core Operating Result Total Revenues<br />
5,865 6,284<br />
883<br />
1,105<br />
7,057<br />
1,752 1,735<br />
7,590** 7,747<br />
1,296<br />
2005 2006 2007* 2008* 2009*<br />
• Group Revenues +2.1% – strong sales<br />
despite rough economic environment<br />
•<br />
Core Operating Result down 25.3% due to<br />
difficult economic environment<br />
• <strong>Merck</strong> Serono on track despite setbacks<br />
•<br />
•<br />
Liquid Crystals recovering after trough at the<br />
beginning of 2009<br />
Results vindicate <strong>Merck</strong>’s risk-diversified<br />
business model<br />
* Core operating result = operating result less costs related to the purchase of Serono (amortization of intangible assets and integration costs).<br />
2005 and 2006 operating result<br />
** 2008 adjusted; total revenues now shown incl. commission income<br />
Page 4
<strong>Merck</strong> Group<br />
FY 2009 - Sales by Region<br />
in € million<br />
1,171<br />
948<br />
223<br />
North America<br />
+15.4%<br />
942<br />
800<br />
142<br />
Europe<br />
-4.2%<br />
Latin America<br />
+16.9%<br />
3,374<br />
2,876<br />
498<br />
1,891<br />
835<br />
1,056<br />
Asia/Africa<br />
Australasia<br />
+1.8%<br />
Pharmaceuticals<br />
Chemicals<br />
Page 5
<strong>Merck</strong> Group<br />
FY 2009 by Division<br />
Revenues by Division €m Operating Result by Division €m<br />
5,014<br />
+6.6%<br />
5,345<br />
<strong>Merck</strong><br />
Serono<br />
+5.7%<br />
442<br />
467<br />
Consumer<br />
Health Care<br />
878<br />
-17%<br />
733<br />
Liquid<br />
Crystals<br />
-3.8%<br />
1,249 1,202<br />
2009<br />
2008<br />
Performance<br />
& Life Science<br />
Chemicals<br />
1,197<br />
-16%<br />
1002<br />
<strong>Merck</strong><br />
Serono*<br />
61<br />
* Core Operating Result<br />
-21%<br />
48<br />
Consumer<br />
Health Care<br />
391<br />
-42%<br />
227<br />
Liquid<br />
Crystals<br />
-42%<br />
167<br />
2009<br />
2008<br />
97<br />
Performance<br />
& LifeScience<br />
Chemicals<br />
Page 6
<strong>Merck</strong> Group<br />
FY 2009 - Close to Group Guidance<br />
Guidance<br />
(Oct. 2009)<br />
<strong>Merck</strong> Serono +6% +7%<br />
* <strong>Merck</strong> Serono and Group ROS guidance based on core operating result<br />
Total Revenues Return on Revenues<br />
Actual FY09<br />
Results<br />
Liquid Crystals –20% –17%<br />
<strong>Merck</strong> Group +2% +2%<br />
Guidance<br />
(Oct. 2009)<br />
(ROS) *<br />
Actual FY09<br />
Results<br />
20% 19%<br />
30% 31%<br />
17% 17%<br />
Page 7
<strong>Merck</strong> Group<br />
FY 2009 – Progress in Strategy<br />
<strong>Merck</strong> Serono<br />
Consumer<br />
Health Care<br />
Liquid Crystals<br />
Performance &<br />
Life Science<br />
Chemicals<br />
• Successful life-cycle management & sustained double-digit growth of key<br />
products Rebif and Erbitux<br />
• Erbitux growth continues despite negative CHMP opinion in lung<br />
• Cladribine tablets in MS in registration in EU; closely working with FDA to<br />
address RTF issues and to prepare re-submission in the US at earliest stage<br />
• China: Sales doubled since 2007; €150 million investment to expand local R&D<br />
• Biologics business in Japan quadrupled in 2009<br />
•<br />
•<br />
•<br />
•<br />
•<br />
•<br />
•<br />
•<br />
•<br />
•<br />
Second-fastest growing TOP 20 company globally<br />
Total organic growth 9%, strategic brands 16%<br />
Recovery of the Liquid Crystal business – stabilizing on a high level<br />
Usage of PS-VA technology increased<br />
Investing into LC innovations OLED, printed electronics, and photovoltaic applicat.<br />
Market & technology leadership maintained<br />
Pigments business recovering<br />
Acquisition of Taizhu in China broadened Pigments business<br />
Laboratory Business: Stable business in difficult environment<br />
Life Science Solutions: Extended strategic partnerships with global customers<br />
CHMP: Committee – of the European Medicines Agency (EMA) - for Medicinal Products for Human Use<br />
MS: Multiple Sclerosis<br />
Page 8
<strong>Merck</strong> Group<br />
FY 2009 - Ongoing commitment to R&D<br />
R&D Expenses<br />
1.600<br />
1.400<br />
1.200<br />
1.000<br />
800<br />
600<br />
400<br />
200<br />
0<br />
1,028<br />
137<br />
891<br />
1,234<br />
143<br />
1.091<br />
1,345<br />
141<br />
1.203<br />
2007 2008 2009<br />
Pharmaceuticals Chemicals<br />
in € million<br />
"Best Pharma" - Research within <strong>Merck</strong> Serono<br />
One result of <strong>Merck</strong> Chemicals' research:<br />
Organic Solar Cells<br />
Page 9
<strong>Merck</strong> Group<br />
Operating Result Q4 2009<br />
€ million Q4 2009 Q4 2008 Δ in %<br />
Total revenues 2,028.8 1,915.4 5.9<br />
Gross margin 1,495.8 1,421.8 5.2<br />
SG&A -875.8 -741.1 18.2<br />
Research & development -358.3 -385.7 -7.1<br />
Amortization of intangibles -217.0 -152.3 42.5<br />
Operating result 44.1 141.9 -68.9<br />
Core operating result 1) 257.5 306.0 -15.8<br />
1) Core operating result = Operating result less costs related to the purchase of Serono (amortization of intangible assets and integration costs)<br />
•<br />
•<br />
•<br />
•<br />
•<br />
•<br />
Gross margin back to normal<br />
level at around 74%<br />
Marketing & selling costs stable<br />
Admin. Costs are down 16%<br />
compared with higher than<br />
usual costs in previous year<br />
Other operating expenses incl.<br />
allowance for Greece (-11 €m),<br />
provisions Venezuela (-16 €m),<br />
litigation expenses (-110 €m)<br />
and asset impairments (-29 €m)<br />
High R&D expense by Pharma<br />
but lower than previous year<br />
due to high spending Q4 2008<br />
Amortization of intangibles<br />
increased due to impairments in<br />
<strong>Merck</strong> Serono of 72 €m<br />
(Puregon and Enbrel)<br />
Page 10
<strong>Merck</strong> Group<br />
Operating Result Full Year 2009<br />
€ million FY 2009 FY 2008 Δ in %<br />
Total revenues 7,747,0 7,589.6 2.1<br />
Gross margin 5,717.7 5,683.6 0.6<br />
SG&A -3,069.9 -2,744.5 11.9<br />
Research & development -1,344.6 -1,234.4 8.9<br />
Amortization of intangibles -657.8 -573.4 14.7<br />
Operating result 648.9 1,131.4 -42.6<br />
Core operating result 1) 1,295.9 1,735.1 -25.3<br />
1) Core operating result = Operating result less costs related to the purchase of Serono (amortization of intangible assets and integration costs)<br />
•<br />
•<br />
•<br />
•<br />
•<br />
Gross Margin holds up well<br />
considering price pressure in<br />
Liquid Crystals and idle<br />
capacity in Liquid Crystals and<br />
Pigments<br />
Marketing & selling costs are<br />
pushed up by commission<br />
expenses in <strong>Merck</strong> Serono<br />
Administration costs are down<br />
due to tight cost control<br />
Other operating expenses<br />
include allowance for<br />
Greece (-13 €m), provision for<br />
Venezuela (-68 €m),<br />
litigation expenses (-167 €m),<br />
and asset impairments (-38 €m)<br />
Amortization of intangibles<br />
affected by Q4 one-off<br />
Page 11
<strong>Merck</strong> Group<br />
Profit after Tax Full Year 2009<br />
€ million FY 2009 FY 2008 Δ in %<br />
Operating result 648.9 1,131.4 -42.6<br />
Exceptionals -28.0 -400.0 -93.0<br />
EBIT 620.9 731.4 -15.1<br />
Financial result -134.5 -156.5 -14.1<br />
Profit before tax 486.4 574.9 -15.4<br />
Income tax -109.7 -195.9 -44.0<br />
Underlying tax rates 21.6% 25.8%<br />
Profit after tax 376.7 379.1 -0.6<br />
Minorities -10.4 -12.0 -13.5<br />
Net income 366.3 367.1 -0.2<br />
EPS (€) 1) reported 1.68 1.69 -0.6<br />
Core EPS (€) 2) 4.44 5.73 -22.5<br />
• Exceptionals Q4 2009 :<br />
• Raptiva provision (exit) of<br />
- 70 €m in Q1 down to<br />
- 40 €m (+30 €m) in Q4<br />
• Sale of natural products<br />
business in Brazil<br />
generates profit of +11 €m<br />
• Better financial result due to<br />
lower debt and lower interest<br />
rates<br />
• Development of Core EPS<br />
influenced by exceptionals of<br />
400 €m in 2008<br />
1) According to IAS 33 EPS is calculated on the average weighted number of shares (FY 2009 and FY 2008: 217.4m)<br />
2) Core EPS: Based on net income less costs related to the purchase of Serono (amortization of intangible assets and integration costs) and exceptionals<br />
Page 12
<strong>Merck</strong> Group<br />
Key Cash Flow Data<br />
€ million FY 2009 FY 2008 Δ in €m<br />
Profit after tax 376.7 379.1 -2.4<br />
Depreciation/amortization 1,003.8 1,215.4 -211.6<br />
Changes in working capital 25.7 -304.3 329.9<br />
Capital expenditures -467.3 -394.7 -72.6<br />
Others -126.4 -457,0 330,7<br />
Free cash flow 812.4 438.4 374.0<br />
Underlying free cash flow<br />
(before acquisition and divestments)<br />
851.6 601.3 250.3<br />
•<br />
•<br />
•<br />
•<br />
Depreciation/amortization with<br />
less impairments than 2008<br />
Good working capital<br />
management, e.g. inventory<br />
decrease despite higher sales<br />
Capex at <strong>Merck</strong> Serono higher<br />
by 82 €m (Biomanufacturing)<br />
Others reflect high level of<br />
provisions included in profit<br />
after tax and lower acquisitions<br />
and purchase of intangibles<br />
Page 13
<strong>Merck</strong> Group<br />
Key Balance Sheet Data<br />
€<br />
million Dec. 31,<br />
2009<br />
in %<br />
of total<br />
assets<br />
Dec. 31,<br />
2008<br />
Total assets 16,713 100 15,645<br />
Equity 9,514 57 9,563<br />
Cash & other liquid funds 2.044 12.2 870<br />
Intangible assets 7,599 45 8,203<br />
Financial debt 2,307 14 1,346<br />
Pension provisions<br />
thereof covered by financial assets<br />
1,312<br />
210<br />
7.9<br />
1.3<br />
1,144<br />
Net financial debt 263 1.6 477<br />
0<br />
•<br />
•<br />
•<br />
Cash and other liquid funds as<br />
well as financial debt up<br />
following 750 €m bond and<br />
230 €m private placements<br />
leading to slightly reduced<br />
equity ratio<br />
210 €m financial assets<br />
covering pensions<br />
Net financial debt exclude<br />
financial assets covering<br />
pensions<br />
Page 14
<strong>Merck</strong> Group<br />
Outlook FY 2010<br />
<strong>Merck</strong> Serono<br />
<strong>Merck</strong> Serono Core<br />
Consumer Health Care<br />
Liquid Crystals<br />
Performance & Life Science Chemicals<br />
<strong>Merck</strong> Group<br />
<strong>Merck</strong> Group Core<br />
Revenue Growth<br />
FY 2010<br />
+ 2-5%<br />
+ 5-10%<br />
+ 5-10%<br />
+ 3-8%<br />
+ 3-7%<br />
Operating Result<br />
Growth FY 2010<br />
30-40%<br />
0-10%<br />
-10-0%<br />
15-25%<br />
15-20%<br />
20-30%<br />
3-13%<br />
Page 15
Pharmaceuticals<br />
Overview Q4 2009<br />
<strong>Merck</strong><br />
Serono<br />
Consumer<br />
Health<br />
Care<br />
<strong>Merck</strong> Serono<br />
1,393 €m<br />
Pharma<br />
Revenues Q4 2009: 1,525 €m<br />
Consumer Health Care<br />
132 €m<br />
• Focus on specialist and innovative drugs in prescription markets<br />
• Build two core therapeutic areas & emerging AIID area, backed by<br />
strong established foundations<br />
• Improve R&D efficiency and leverage biopharmaceutical expertise<br />
• Focus on over-the-counter pharma products in four health themes<br />
• Grow key brands through regional expansion<br />
• Strengthen business in established markets<br />
Page 16
<strong>Merck</strong> Serono<br />
Key Financials Q4 2009<br />
€ million Q4 2009 Q4 2008 Δ in %<br />
Sales 1,298.3 1,226.1 5.9<br />
Royalty/commission<br />
income<br />
Marketing & selling<br />
(excl. commission and royalty expenses)<br />
94.3 110.2 -14.4<br />
-345.4 -368.7 -6.3<br />
Royalty/commission exp. -107.5 -87.9 22.3<br />
Research & development -316.3 -340.2 -7.0<br />
Core operating result* 144.4 224.2 -35.6<br />
Core ROS (return on<br />
revenues)<br />
10.4% 17.3%<br />
Underlying free cash flow<br />
(before acquisitions and divestments) 185.8 111.1 67.2<br />
* Core operating result = Operating result less costs related to the purchase of Serono (amortization of intangible assets and integration costs)<br />
• Organic revenue growth +7.2%;<br />
slight headwind from FX (-2.2%)<br />
• Commission and royalty income<br />
continuing to decrease as expected<br />
• Lower marketing & selling compared<br />
to Q4/2008 due to exceptionally high<br />
expenses in Q4/2008, increase<br />
compared to Q3 2009 due to yearend<br />
spending<br />
• Higher royalty and commission<br />
expenses because of higher sales of<br />
in-licensed products and copromotion<br />
in cooperation with<br />
partners<br />
• High R&D expenses, but Q4/09 vs<br />
Q4/08 lower due to exceptionally<br />
high expenses in Q4/2008<br />
• Free cash flow up due to improved<br />
working capital management<br />
Page 17
<strong>Merck</strong> Serono<br />
Operational Developments Q4 2009<br />
Sales by Therapeutic Area<br />
Neurodegen.<br />
Diseases<br />
Oncology<br />
Fertility<br />
Endocrinology<br />
CMC/local<br />
Rebif<br />
Er bitux<br />
Gonal-f<br />
Concor<br />
Glucophage<br />
Saizen<br />
51<br />
47<br />
70<br />
63<br />
76<br />
66<br />
128<br />
115<br />
99<br />
107<br />
189<br />
144<br />
165<br />
144<br />
+11%<br />
Sales by Top 6 Products<br />
187<br />
141<br />
-7.3%<br />
+15%<br />
+7.9%<br />
+15%<br />
+11%<br />
+31%<br />
+33%<br />
402<br />
360<br />
401<br />
360<br />
+12%<br />
470<br />
486<br />
+11%<br />
€m<br />
Q4 2009<br />
Q4 2008<br />
-3.5%<br />
€m<br />
Q4 2009<br />
Q4 2008<br />
•<br />
•<br />
•<br />
•<br />
•<br />
Rebif with 5% growth in Europe supported<br />
by launch of RebiSmart<br />
Erbitux performance driven by:<br />
•<br />
•<br />
Launch of 1st line head & neck cancer<br />
in Q4 2008<br />
Strong penetration into metastatic<br />
colorectal cancer 1st line following<br />
personalization of treatment for KRAS<br />
wild-type patients in Q3 2008<br />
Gonal-f continues to be strong supported by<br />
launch of New Generation Gonal-f pen;<br />
further penetration of Pergoveris<br />
Glucophage sales growth driven by good<br />
performance in emerging markets<br />
Sustained growth with Saizen supported by<br />
easypod device; further penetration of<br />
Kuvan into additional markets<br />
Page 18
<strong>Merck</strong> Serono<br />
Neurodegenerative Diseases<br />
Rebif<br />
•<br />
Continued rollout of the electronic injection device RebiSmart;<br />
now available in more than 10 countries (key EU & Canada)<br />
Cladribine Tablets<br />
•<br />
USA: Working closely with FDA to address RTF issues and to<br />
to prepare re-submission at earliest possible time<br />
Atacicept (incl. AIID)<br />
•<br />
Phase II trials terminated in 2009:<br />
–<br />
–<br />
MS: Voluntary discontinuation of Phase II program after<br />
observation of increased disease activity in some<br />
atacicept-treated patients in one study (September 2009)<br />
RA (AIID): Decision not to move to Phase III due to<br />
insufficient clinical efficacy in order to develop a<br />
competitive product profile<br />
<strong>Merck</strong> Rebif Sales €m<br />
368 387 381 401<br />
360<br />
313 320<br />
338<br />
Q1 2008<br />
Q2 2008<br />
Q3 2008<br />
Q4 2008<br />
Q1 2009<br />
Q2 2009<br />
Q3 2009<br />
Q4 2009<br />
Page 19
<strong>Merck</strong> Serono<br />
Oncology<br />
Erbitux<br />
•<br />
Committee for Medicinal Products for Human Use (CHMP*)<br />
adopted negative opinion for treatment of lung cancer (Nov. 09)<br />
after <strong>Merck</strong> had requested re-examination of first negative CHMP<br />
Opinion received in July 09<br />
Stimuvax<br />
•<br />
Expanded Phase III clinical trial program<br />
–<br />
–<br />
–<br />
Cilengitide<br />
•<br />
START (NSCLC) ongoing<br />
STRIDE (breast cancer – initiated June 2009)<br />
INSPIRE (NSCLC – Asian regions – initiated December 2009)<br />
Ongoing Phase III trial in Glioblastoma multiforme (CENTRIC)<br />
IMO-2055<br />
•<br />
Start Phase II study in head and neck<br />
* CHMP: Committee – of the European Medicines Agency (EMA) - for Medicinal Products for Human Use<br />
<strong>Merck</strong> Erbitux Sales €m<br />
187<br />
162<br />
171 177<br />
145 145<br />
134 141<br />
Q1 2008<br />
Q2 2008<br />
Q3 2008<br />
Q4 2008<br />
Q1 2009<br />
Q2 2009<br />
Q3 2009<br />
Q4 2009<br />
Page 20
<strong>Merck</strong> Serono<br />
Pipeline Portfolio as of Februry<br />
Phase I<br />
Aurora kinase inhibitor (AS703569)<br />
Solid tumors and hematological<br />
malignancies<br />
MEK inhibitor (AS703026)<br />
Solid tumors and hematological<br />
malignancies<br />
Sonepcizumab<br />
anti-S1P mAb<br />
Solid tumors<br />
c-Met kinase inhibitor<br />
(EMD 1214063)<br />
Solid tumors<br />
Fibroblast Growth Factor 18<br />
Osteoarthritis<br />
Phase II<br />
Erbitux ® (cetuximab),<br />
anti-EGFR mAB<br />
Breast cancer<br />
Tucotuzumab celmoleukin,<br />
immunocytokine<br />
Small cell lung cancer (SCLC)<br />
Cilengitide, integrin inhibitor<br />
SCCHN<br />
Cilengitide, integrin inhibitor<br />
NSCLC<br />
Adecatumumab,<br />
anti-EpCAM mAb<br />
Colorectal Cancer<br />
Anti-integrin mAb (DI17E6)<br />
Colorectal Cancer<br />
TLR9 immunomodulator<br />
(IMO-2055)<br />
SCCHN<br />
ARX 201, long acting GH<br />
Growth hormone deficiencies<br />
*Sponsored and coordinated by the Fédération Francophone de Cancérologie Digestive (FFCD)<br />
2010<br />
Phase III<br />
Rebif New Formulation in CIS<br />
(REFLEX)<br />
Cladribine tablets in CIS (ORACLE)<br />
Safinamide (MOTION)<br />
Early stage Parkinson’s<br />
Safinamide (SETTLE)<br />
Mid-to-late stage Parkinson’s<br />
Erbitux ® (cetuximab),<br />
anti-EGFR mAb (PETACC-8*)<br />
Adj Colon Cancer<br />
Erbitux ® (cetuximab),<br />
anti-EGFR mAb (EXPAND)<br />
Gastric Cancer<br />
Cilengitide, integrin inhibitor<br />
(CENTRIC)<br />
Glioblastoma<br />
Stimuvax ® , therapeutic cancer vaccine<br />
(START, INSPIRE)<br />
NSCLC<br />
Stimuvax ® , therapeutic cancer<br />
vaccine (STRIDE)<br />
Breast Cancer<br />
Atacicept, anti-Blys/anti-APRIL fusion<br />
protein (APRIL)<br />
Systemic Lupus Erythematosus<br />
in Registration<br />
Rebif New Formulation<br />
Relapsing forms of MS<br />
FDA: Application submitted<br />
Cladribine tablets<br />
Relapsing forms of MS<br />
EMEA: Application submitted<br />
FDA: Preparing re-submission<br />
Tesamorelin<br />
Excess abdominal fat in HIV patients with<br />
lipodystrophy<br />
FDA: Application submitted<br />
� Oncology<br />
� Neurodegenerative Diseases<br />
� Autoimmune & Inflammatory<br />
Diseases<br />
� Endocrinology<br />
Page 21
<strong>Merck</strong> Serono<br />
Pipeline Catalysts 12 Months Rolling<br />
� Oncology<br />
� Neurodegenerative Diseases<br />
� Autoimmune & Inflammatory<br />
Diseases<br />
� Endocrinology<br />
FDA Action Letter<br />
expected for<br />
Tesamorelin to treat<br />
excess abdominal fat in<br />
HIV patients with<br />
lipdystrophy<br />
Q1 Q2 Q3<br />
2010<br />
PMDA: Pharmaceuticals & Medical Devices Agency „Japan“<br />
Phase III data from Rebif in CIS (REFLEX<br />
study)<br />
CHMP opinion expected<br />
for cladribine tablets in<br />
relapsing MS<br />
PMDA decision: Erbitux in 1st line mCRC<br />
Q4<br />
Page 22
Consumer Health Care<br />
Key Financials Q4 2009<br />
€ million Q4 2009 Q4 2008 Δ in %<br />
Total revenues 132.4 113.0 17<br />
Marketing & selling -60.6 -50.0 21<br />
Research & development -6.7 -6.1 10<br />
Operating result 8.6 11.1 -22<br />
ROS (return on revenues) 6.5% 9.8%<br />
Underlying free cash flow<br />
(before acquisitions and divestments)<br />
19.6 3.3 …<br />
• Organic revenue growth 20.3%,<br />
FX headwind of -3.0%<br />
• Continue to focus on seven<br />
strategic brands – penetration<br />
of key markets. Regional<br />
expansion of strategic brands to<br />
Latin America and Asia<br />
• Higher marketing costs for<br />
Femibion in Germany and<br />
launch in UK; 'healthy<br />
pregnancy' launch in Spain;<br />
push Bion sales in France and<br />
new launch in Canada;<br />
Kidabion products launched in<br />
China<br />
• Operating result down due to<br />
product launch costs and higher<br />
other operating expenses<br />
Page 23
Consumer Health Care<br />
Operational Developments<br />
Sales by Health Theme<br />
Mobility<br />
Women's and<br />
Children's<br />
Health<br />
Everyday<br />
Health<br />
Protection<br />
Cough & Cold<br />
Others<br />
16.5<br />
14.1<br />
17.4<br />
15.8<br />
14.5<br />
-5.5%<br />
+9.5%<br />
26.3<br />
24.5<br />
27.6<br />
+73%<br />
38.9<br />
-4.6%<br />
48.8<br />
€m<br />
Q4 2009<br />
Q4 2008<br />
+25%<br />
Strategic brands showed strong growth<br />
•<br />
•<br />
•<br />
•<br />
•<br />
•<br />
•<br />
Kytta +42% (Mobility): mainly due to strong<br />
marketing in our main market Germany<br />
Femibion +44% (Women’s): strong<br />
underlying growth boosted by launches in<br />
France and UK<br />
Cebion +38% (EHP): strong performance in<br />
Venezuela<br />
Bion3 +22% (EHP): ongoing great<br />
performance in France<br />
Diabion +129% (EHP): boosted by launch<br />
in China<br />
Nasivin -16% (Cough & Cold): economic<br />
downturn in Russia plus generally poor<br />
winter season in Europe<br />
Others: Reflects Belgian acquisition and<br />
Cape June success<br />
Page 24
Chemicals<br />
Overview Q4 2009<br />
Liquid<br />
Crystals<br />
Performance &<br />
Life Science<br />
Chemicals<br />
Liquid Crystals<br />
201 €m<br />
Chemicals<br />
Revenues Q4 2009: 504 €m<br />
Performance & Life Science Chemicals<br />
303 €m<br />
• Focus on innovation in display technologies to sustain market leadership<br />
• Capitalize on excellent reputation in quality and reliability<br />
• Broaden application basis long-term with penetration into new markets<br />
• Focus on specialty chemicals solutions<br />
• Leverage strong expertise in regulated markets with high entry barriers<br />
• Strengthen position in focus regions: India and China<br />
Page 25
Liquid Crystals<br />
Key Financials Q4 2009<br />
€ million Q4 2009 Q4 2008 Δ in %<br />
Total revenues 201.1 167.3 20<br />
Marketing & selling -7.4 -6.9 7.4<br />
Research & development -21.1 -23.3 -10<br />
Operating result 91.1 52.4 74<br />
ROS (return on revenues) 45.3% 31.3%<br />
Underlying free cash flow<br />
(before acquisitions and divestments)<br />
106.7 69.7 53<br />
• Recovering manifested by<br />
revenue performance, despite<br />
4% FX headwind<br />
• Gross margin reflects price<br />
pressure<br />
• Return on sales as guided in<br />
Q3<br />
• Cash flow up in line with<br />
operating result<br />
Page 26
Liquid Crystals<br />
Business Dynamics<br />
Quarterly Business Development 2008 - 2009<br />
250<br />
200<br />
150<br />
100<br />
50<br />
0<br />
234<br />
119<br />
Q1<br />
2008<br />
238<br />
107<br />
Q2<br />
2008<br />
Operating Result Revenues<br />
239<br />
112<br />
Q3<br />
2008<br />
167<br />
52 52<br />
13<br />
Q4<br />
2008<br />
131<br />
Q1<br />
2009<br />
189<br />
Q2<br />
2009<br />
211 201<br />
72<br />
Q3<br />
2009<br />
91<br />
€m<br />
Q4<br />
2009<br />
FY 2009:<br />
• Volume 2009 on previous years<br />
level<br />
•<br />
•<br />
•<br />
Market share down, but still<br />
above 50%<br />
ROS in worst quarter ever still<br />
at 10%<br />
Success story PS-VA<br />
technology<br />
Page 27
Liquid Crystals<br />
Attractive market for LC Displays<br />
Area in (km 2 )<br />
150<br />
100<br />
50<br />
0<br />
13% compound annual growth rate<br />
2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3 2 0 1 4 2 0 1 5<br />
Source: DisplaySearch, Long-term demand forecast Q4 2009<br />
Others<br />
Notebook PC<br />
Desktop Monitor<br />
LCD TV<br />
Page 28
Liquid Crystals<br />
Investing into innovations<br />
Displays .<br />
•<br />
Latest development:<br />
PS-VA<br />
• 3D applications<br />
• Flexible displays<br />
• OLED materials<br />
Photovoltaics<br />
•<br />
•<br />
•<br />
•<br />
Structuring and<br />
process chemicals<br />
Materials for organic<br />
thin film cells<br />
Ionic liquids for dye<br />
solar cells<br />
Anti-reflective<br />
coatings<br />
.<br />
Lighting .<br />
• OLED for lighting<br />
• Phospors LED<br />
•<br />
•<br />
Printed Electronics<br />
Organic<br />
electronics<br />
Inorganic<br />
semiconductors<br />
Page 29
Performance & Life Science Chemicals<br />
Key Financials Q4 2009<br />
€ million Q4 2009 Q4 2008 Δ in %<br />
Total revenues 302.6 298.7 1.3<br />
Marketing & selling -80.4 -81.8 -1.7<br />
Research & development -14.1 -16.0 -11.7<br />
Operating result 33.6 35.9 -6.4<br />
ROS (return on revenues) 11.1% 12.0%<br />
Underlying free cash flow<br />
(before acquisitions and divestments)<br />
36.1 16.4 …<br />
• Recovery in Pigments sales<br />
• Free cash flow reflects EBIT<br />
improvement<br />
Page 30
Performance & Life Science Chemicals<br />
Operational Developments Q4 2009<br />
Sales by Region<br />
Europe<br />
Asia<br />
North<br />
America<br />
Latin<br />
America<br />
Rest of<br />
World<br />
11<br />
9<br />
35<br />
36<br />
+19%<br />
50<br />
55<br />
-4.1%<br />
72<br />
82<br />
-9.7%<br />
+14%<br />
€m<br />
124<br />
125<br />
-1.0%<br />
Q4 2009<br />
Q4 2008<br />
• Sales growth driven from Asia<br />
(+14%): mainly Indonesia, China,<br />
and India<br />
• North America development of<br />
-9.7% mainly caused by FX<br />
headwind<br />
• Strengthening of Laboratory<br />
business in India through<br />
acquisition of Bangalore<br />
Genei/India<br />
• Ongoing recovery of pigments<br />
business and further growth<br />
potential through the integration of<br />
Taizhu in China (acquisition in Q3)<br />
Page 31
Appendix<br />
Company Overview<br />
A<br />
B<br />
C<br />
D<br />
E<br />
F<br />
Company Overview<br />
<strong>Merck</strong> Serono<br />
Consumer Healthcare<br />
Liquid Crystals<br />
Performance & Life Science Chemicals<br />
Financial Results in Detail<br />
Page 33<br />
Page 38<br />
Page 57<br />
Page<br />
59<br />
Page 64<br />
Page 68<br />
Page 32
<strong>Merck</strong> Group<br />
Long Tradition in Pharma<br />
•<br />
•<br />
•<br />
•<br />
•<br />
•<br />
Oldest pharma<br />
Diversification in pharma<br />
& Chemicals<br />
and chemicals company in the world –<br />
and chemicals to spread risk<br />
~70% family ownership; ~30% public ownership by shares<br />
since 1668<br />
Broad global presence with more than 33,000 employees worldwide<br />
Proven competence in acquisitions und divestitures<br />
Expropriation of the US subsidiary after World War I (→ <strong>Merck</strong> & Co.)<br />
Page 33
<strong>Merck</strong> Group<br />
Ownership Structure<br />
General partner with<br />
equity interest<br />
•<br />
•<br />
<strong>Merck</strong> family<br />
(Approx. 130 partners)<br />
100.0%<br />
E. <strong>Merck</strong> KG<br />
70.3%<br />
<strong>Merck</strong> <strong>KGaA</strong><br />
Capital share of general partner E. <strong>Merck</strong> KG: 397.2 €m<br />
Share capital: 168.0 €m<br />
Shareholders<br />
29.7%<br />
Limited liability<br />
shareholders<br />
General partners<br />
without equity<br />
interest =<br />
Executive Board<br />
of <strong>KGaA</strong><br />
= 152.8 m share equivalents<br />
= 64.6 m shares<br />
= 70.3%<br />
= 29.7%<br />
Page 34
<strong>Merck</strong> Group<br />
Strategy Principles<br />
Sustain<br />
Local entrepreneurship<br />
Customer focus and internationalization<br />
Production and marketing of specialties<br />
Orientation on mission statement and corporate values<br />
Change<br />
Modernize structures and processes<br />
Globalize businesses<br />
Create global “Company signature”<br />
Grow<br />
Focus on profitable growth<br />
Take advantage of synergies in the markets<br />
Use innovation power in Pharma and fuel innovations in Chemicals<br />
Selective acquisitions<br />
Page 35
<strong>Merck</strong> Group<br />
Specialties in Pharmaceuticals & Chemicals<br />
Total Revenues 1) Core Operating Result 1)<br />
Performance & Life<br />
Science Chemicals<br />
Liquid<br />
Crystals<br />
Consumer<br />
Healthcare<br />
Pharmaceuticals Chemicals<br />
Pharmaceuticals Chemicals<br />
16%<br />
9%<br />
FY2009:<br />
6% 7,747 €m 69%<br />
<strong>Merck</strong><br />
Serono<br />
Performance & Life<br />
Science Chemicals<br />
7%<br />
Liquid<br />
Crystals<br />
17%<br />
Consumer<br />
Healthcare<br />
FY2009:<br />
1,296 €m 2)<br />
1) Deltas between sum of Pharmaceuticals and Chemicals revenues and operating results, respectively, due to corporate/other segment (2009: -78 €m of operating result)<br />
2) Core operating result is before PPA amortization and before integration/restructuring costs mainly related to Serono acquisition<br />
3%<br />
73%<br />
<strong>Merck</strong><br />
Serono 2)<br />
Page 36
<strong>Merck</strong> Group<br />
Revenue Growth Analysis FY 2009<br />
Nominal Organic Currency<br />
Acquisitions/<br />
Divestments<br />
<strong>Merck</strong> Serono 6.6% 6.8% -0.0% -0.2%<br />
Consumer Health Care 5.7% 8.6% -4.5% 1.5%<br />
Liquid Crystals -16.6% -16.7% 0.1% 0.0%<br />
Performance & Life Science<br />
Chemicals<br />
-3.8% -4.5% 0.4% 0.3%<br />
<strong>Merck</strong> Group 2.1% 2.2% -0.2% 0.0%<br />
Page 37
<strong>Merck</strong> Serono<br />
Innovation in Strategic<br />
Future growth drivers:<br />
2 core areas<br />
Solid<br />
foundation<br />
Oncology<br />
Core Areas<br />
<strong>Merck</strong> Serono<br />
Autoimmune<br />
&<br />
Inflammatory<br />
Disease<br />
Fertility<br />
Endocrinology<br />
Neurodegenerative<br />
Diseases<br />
Cardiometabolic Care & General Medicines<br />
Page 38
<strong>Merck</strong> Serono<br />
Focus on Specialist Therapeutic Areas<br />
<strong>Merck</strong> Serono – Business Focus<br />
Neurodegenerative Diseases<br />
Oncology<br />
Fertility<br />
Endocrinology<br />
Cardiometabolic Care & General Medicines<br />
Focus on breakthrough medical solutions in Specialist Therapeutic Areas<br />
Page 39
<strong>Merck</strong> Serono<br />
Product Portfolio<br />
37%<br />
1%<br />
5% 12%<br />
14%<br />
FY 2009<br />
Sales by Therapeutic Areas Sales by Key Products<br />
Cardiometabolic Care<br />
& General Medicines<br />
Endocrinology<br />
2009:<br />
€4994m<br />
Fertility<br />
AIID<br />
Oncology<br />
31%<br />
Neurodegenerative<br />
Diseases<br />
Rebif<br />
Erbitux<br />
Gonal-f<br />
Concor<br />
Glucophage<br />
Saizen<br />
191<br />
172<br />
305<br />
290<br />
486<br />
460<br />
413<br />
433<br />
697<br />
565<br />
+5.2%<br />
+11%<br />
+5.8%<br />
-4.6%<br />
+23%<br />
1537<br />
1331<br />
€m<br />
+15%<br />
2009<br />
2008<br />
Page 40
<strong>Merck</strong> Serono<br />
Neurodegenerative Diseases<br />
Rebif<br />
•<br />
Rebif (interferon beta-1a) is a disease modifying drug used to treat<br />
relapsing forms of MS. Similar to the interferon beta protein produced<br />
by the human body, interferons are thought to help modulate the<br />
body’s immune system and reduce inflammation.<br />
Cladribine Tablets<br />
•<br />
An oral short-course, disease-modifying treatment for MS, Cladribine<br />
is a small molecule that interferes with the behaviour and proliferation<br />
of certain white blood cells, particularly lymphocytes, which are<br />
thought to be involved in the pathological process of MS.<br />
Safinamide<br />
•<br />
•<br />
<strong>Merck</strong> Serono and its partner Newron are developing Safinamide, a alpha-aminoamide derivative<br />
formulated for oral administration that is currently being developed as an add-on treatment for both,<br />
early and mid-to-late stage patients with PD<br />
Phase III studies are ongoing<br />
–<br />
–<br />
Neurodeg. Dis. Sales €m<br />
368 387 381 402<br />
360<br />
313 320 338<br />
Q1 2008<br />
Q2 2008<br />
Q3 2008<br />
Q4 2008<br />
Q1 2009<br />
Q2 2009<br />
Q3 2009<br />
MOTION: Safinamide as add-on to dopamine agonist in early-stage Parkinson’s Disease<br />
SETTLE: Safinamide as add-on to levodopa in mid-to-late stage Parkinson’s Disease<br />
Q4 2009<br />
Page 41
<strong>Merck</strong> Serono<br />
Rebif – A Leader in the MS Market<br />
Leading drug against relapsing Multiple Sclerosis (MS) outside<br />
the US with double digit growth rate in the US<br />
•<br />
•<br />
Approved for the treatment of relapsing MS in 90 countries<br />
worldwide<br />
Favorable benefit-to-risk profile:<br />
–<br />
–<br />
Proven efficacy on three key measures of treatment<br />
effectiveness (MRI, relapse rate, disability progression)<br />
Long term safety supported by 8 years of clinical data and over<br />
a decade of clinical experience<br />
Active life-cycle management initiatives<br />
•<br />
•<br />
Formulation enhancements (Rebif New Formulation)<br />
Innovative injection devices<br />
–<br />
–<br />
RebiSmart:<br />
•<br />
•<br />
First electronic injection device in MS<br />
Designed for ease of use and increased patient adherence to<br />
treatment<br />
Label extension (Rebif in CIS – REFLEX study)<br />
<strong>Merck</strong> Rebif Sales €m<br />
581<br />
723<br />
875<br />
1,157<br />
1,018<br />
1.537<br />
1,331<br />
1,218<br />
2002<br />
2003<br />
2004<br />
2005<br />
2006<br />
2007<br />
2008<br />
2009<br />
Page 42
<strong>Merck</strong> Serono<br />
Cladribine – Oral Treatment in MS<br />
•<br />
•<br />
•<br />
•<br />
Orally administered disease-modifying agent could transform the lives of MS patients<br />
Working closely with the FDA to address RTF issues and to prepare the re-submission in the US at<br />
the earliest possible time<br />
Marketing authorization application submitted in Europe in July 2009. EU application accepted and<br />
currently under review, with CHMP opinion expected in 3Q10.<br />
Ongoing studies with Cladribine Tablets:<br />
Extension<br />
Subjects Status<br />
~ 800<br />
~600<br />
~200<br />
Extension study of pivotal 2-year Phase III monotherapy trial in patients<br />
with relapsing MS<br />
Phase III study of two doses of cladribine tablets vs placebo in<br />
preventing conversion to MS in subjects with a first clinical<br />
demyelinating event at high risk of converting to MS<br />
Phase II safety study of cladribine tablets added to interferon therapy in<br />
patients with active MS<br />
Page 43
<strong>Merck</strong> Serono<br />
Cladribine – Oral Treatment in MS<br />
CLARITY Study: Design<br />
•<br />
•<br />
•<br />
•<br />
2-year Phase III study; 1,326 patients with relapsingremitting<br />
MS (RRMS)<br />
Short course treatment: 1 course = 1-2 tablets (10mg)<br />
for 4 or 5 consecutive days/month depending on patient<br />
weight<br />
Year 1: courses for 2 or 4 consecutive months,<br />
depending on dose regimen (3.5mg/kg or 5.25 mg/kg)<br />
Year 2: courses for 2 consecutive months<br />
CLARITY Study: Results published in NEJM<br />
•<br />
•<br />
•<br />
Primary and secondary endpoints met with high levels of statistical significance<br />
~90% patients in each group completed treatment; low drop-out rate due to adverse events suggests<br />
good tolerability<br />
Overall adverse event rates comparable between treatment groups:<br />
–<br />
–<br />
Differences consistent with mechanism of action<br />
Observed malignancies were isolated cases across different organ systems<br />
Page 44
<strong>Merck</strong> Serono<br />
Oncology<br />
Erbitux<br />
•<br />
CHMP* adopted negative opinion for treatment of lung cancer (Nov.<br />
09) after <strong>Merck</strong> had requested re-examination of first negative<br />
CHMP Opinion received in July 09<br />
Stimuvax<br />
•<br />
Expanded Phase III clinical trial program<br />
–<br />
–<br />
–<br />
Cilengitide<br />
•<br />
START (NSCLC) ongoing<br />
STRIDE (breast cancer – initiated June 2009)<br />
INSPIRE (NSCLC – Asian regions – initiated December 2009)<br />
Ongoing Phase III trial in Glioblastoma multiforme (CENTRIC)<br />
IMO-2055<br />
•<br />
Start Phase II study in head and neck<br />
*CHMP: Committee - of the European Medicines Agency (EMA) - for Medicinal Products for Human<br />
Oncology Sales €m<br />
163 173 179 189<br />
148 147<br />
136 144<br />
Q1 2008<br />
Q2 2008<br />
Q3 2008<br />
Q4 2008<br />
Q1 2009<br />
Q2 2009<br />
Q3 2009<br />
Q4 2009<br />
Page 45
<strong>Merck</strong> Serono<br />
Erbitux ® – On the growth path<br />
•<br />
•<br />
•<br />
•<br />
Indication Approved<br />
3rd /2nd line mCRC in EU Jun 04<br />
Locally advanced SCCHN in EU Apr 06<br />
1 st<br />
line mCRC in EU July 08<br />
3rd /2nd line mCRC in Japan July 08<br />
Recurrent/metastatic SCCHN in EU Nov 08<br />
Metastatic colorectal cancer (mCRC) in EU: KRAS screening & reimbursement processes<br />
established<br />
National Institute for Health and Clinical Excellence (NICE/UK): positive recommendation to use<br />
Erbitux as 1st line treatment in mCRC (patients with KRAS wild-type tumors and unresectable<br />
metastases limited to the liver) ► Erbitux is the only targeted therapy endorsed by NICE for the 1stline<br />
treatment of the disease<br />
Committee for Medicinal Products for Human Use (CHMP) adopted negative opinion for treatment of<br />
lung cancer (Nov. 2009) after <strong>Merck</strong> had requested re-examination of first negative CHMP Opinion<br />
received in July 09<br />
Erbitux now approved for mCRC in 78 countries, for SCCHN in 73 countries<br />
<strong>Merck</strong> Erbitux Sales €m<br />
77<br />
218<br />
337<br />
470<br />
565<br />
697<br />
2004 2005 2006 2007 2008 2009<br />
Page 46
<strong>Merck</strong> Serono<br />
Erbitux ® – Achievements<br />
•<br />
•<br />
•<br />
•<br />
Congress data on CRC<br />
–<br />
–<br />
Final CRYSTAL results: significant overall survival benefit<br />
of 3.5 months (ECCO/ESMO) in 1st line mCRC* patients<br />
with KRAS wild-type status in combination with FOLFIRI<br />
Erbitux treatment effect does not vary by BRAF mutation<br />
status in CRYSTAL (ASCO GI)<br />
Erbitux recommended for 1st line NSCLC in guidelines of<br />
–<br />
–<br />
–<br />
–<br />
–<br />
ASCO<br />
NCCN (National Comprehensive Cancer Network)<br />
NCCN Asia<br />
AIOT (Italian Association of Thoracic Oncology)<br />
SAOC (South African Oncology Consortium)<br />
ESMO 2009 guidelines for head and neck cancer:<br />
–<br />
–<br />
Erbitux with platinum based chemotherapy rated exclusively with highest grade of evidence (grade I)<br />
and highest grade of recommendation (grade A) in recurrent/ metastatic setting<br />
Erbitux in combination with radiotherapy in locally advanced setting on par with concomitant<br />
chemoradiation, also rated with grade IA<br />
Erbitux recognized by ASCO as major advance: first SCCHN 1st-line treatment to improve survival in 30 yrs<br />
*mCRC: metastatic Colorectal Cancer SCCHN: Squamous Cell Carcinoma of the Head&Neck<br />
Page 47
<strong>Merck</strong> Serono<br />
Metastatic Colorectal<br />
KRAS status<br />
distribution<br />
in mCRC<br />
KRAS mt<br />
35%<br />
KRAS wt<br />
65%<br />
Cancer<br />
1st-line<br />
96,491 pts*<br />
KRAS wt<br />
62,719 pts*<br />
Market<br />
2nd-line<br />
18,535 pts*<br />
KRAS wt<br />
12,048 pts*<br />
3rd-line<br />
10,263 pts*<br />
KRAS wt<br />
6,671 pts*<br />
28 weeks 20 weeks 16 weeks<br />
Treatment Duration<br />
* Data for Europe Big Five, Source: OncFoundation v5 Nov 2009 projections for 2009<br />
Page 48
<strong>Merck</strong> Serono<br />
Benefit of personalized therapy<br />
Response rate (%)<br />
70<br />
60<br />
50<br />
40<br />
30<br />
20<br />
10<br />
0<br />
Biomarker selection with<br />
KRAS:<br />
Identified up to 65 % p’ts<br />
(KRAS wt) treated with<br />
personalized therapy<br />
CRYSTAL OPUS<br />
p
<strong>Merck</strong> Serono<br />
Fertility<br />
Global market leader in fertility treatments, offering:<br />
•<br />
•<br />
•<br />
•<br />
•<br />
•<br />
Broadest range of complementary products for infertility<br />
Recombinant forms for all three gonadotropins needed in a<br />
treatment cycle<br />
Available in 100 countries<br />
Share gains in US market, strong growth in China, Brazil<br />
Next generation Gonal-f pen launched in over 30 countries, including key EU and US<br />
Slowing market growth in volume & reduced average selling price<br />
Fertility Sales<br />
€m<br />
164 165<br />
140 147 140<br />
148 133 144<br />
Q1 2008<br />
Q2 2008<br />
Q3 2008<br />
Q4 2008<br />
Q1 2009<br />
Q2 2009<br />
Q3 2009<br />
Q4 2009<br />
Page 50
<strong>Merck</strong> Serono<br />
Endocrinology<br />
Saizen<br />
well positioned to compete given breadth of indications and device<br />
differentiation strategy<br />
• easypod ® electronic injection device launched Q1/07, available in<br />
•<br />
almost 40 countries by end 2009<br />
Family of delivery devices and customer services driving growth<br />
Serostim<br />
approved for HIV-associated wasting in US<br />
• Access education for patients & provider to strengthen understanding of<br />
Medicare Part D simplified reimbursement in some states<br />
• Designated as an orphan drug by FDA<br />
Kuvan<br />
first treatment available in Europe for the treatment of hyperphenylalaninemia<br />
(HPA) in phenylketonuria or BH4 deficient patients<br />
• Soluble tablets, administered once daily<br />
• Orphan drug status in Europe<br />
• Uncontrolled HPA can cause serious brain damages in infants and<br />
children, and transient to lasting neurocognitive impairment in adult<br />
patients<br />
Endocrinology Sales €m<br />
52<br />
56 58 63<br />
cool.click<br />
needle-free device<br />
61 65 66 70<br />
Q1 2008<br />
Q2 2008<br />
Q3 2008<br />
Q4 2008<br />
Q1 2009<br />
Q2 2009<br />
Q3 2009<br />
Q4 2009<br />
easypod<br />
one.click<br />
autoinjector<br />
Page 51
<strong>Merck</strong> Serono<br />
Cardiometabolic<br />
Concor / Bisoprolol Products<br />
•<br />
•<br />
Concor ®<br />
Care<br />
family: among the leading beta-blockers in many countries<br />
Strong sales growth in emerging markets partly compensating for<br />
generic competition of our heart failure drug in Europe<br />
Glucophage / Metformin Products<br />
•<br />
•<br />
Robust sales development within the last years despite generic<br />
competition due to successful life-cycle management, e.g. launch<br />
of Glucophage XR and Glucovance in 2009<br />
Global guideline of ADA/ EASD recommend Metformin as first line<br />
therapy for type-II diabetes together with diet and exercise<br />
Euthyrox & other thyroid products<br />
•<br />
•<br />
In Europe, Latin America and China, we are market leader<br />
CM Care Sales €m<br />
438 473 462 470<br />
434<br />
456 460<br />
486<br />
Q1 2008<br />
Q2 2008<br />
Q3 2008<br />
Q4 2008<br />
Q1 2009<br />
Q2 2009<br />
Q3 2009<br />
Q4 2009<br />
Epidemiological data suggest, that only 20% of people suffering from hypothyroidism are treated –<br />
high treatment need<br />
Page 52
<strong>Merck</strong> Serono<br />
Tesamorelin<br />
Background<br />
•<br />
•<br />
Tesamorelin is a growth hormone-releasing factor analogue with therapeutic potential in a variety of<br />
anabolic and lipolytic indications<br />
<strong>Merck</strong> has exclusive commercialization rights to Tesamorelin in the US in this indication per the<br />
collaboration and licensing agreement with Theratechnologies entered in October 2008<br />
Status<br />
•<br />
•<br />
•<br />
Partner Theratechnologies submitted Tesamorelin NDA to FDA on May 29, 2009 for the treatment of<br />
excess abdominal fat in HIV patients with lipodystrophy<br />
FDA filed the NDA on August 12, 2009 and PDUFA date for Tesamorelin is March 29, 2010<br />
On January 25, 2010 Theratechnologies announced that due to an administrative delay at FDA not<br />
related to the NDA, a meeting of the Endocrinologic & Metabolic Drugs advisory committee will be<br />
rescheduled<br />
NDA: New drug application;<br />
PDUFA:<br />
Prescription Drug User Fee Act<br />
Page 53
<strong>Merck</strong> Serono<br />
Stimuvax ® – BLP25 Cancer Vaccine<br />
Background:<br />
•<br />
•<br />
Stimulates specifically the body‘s immune system to fight<br />
cancer<br />
Targets specifically the tumor antigen MUC1:<br />
–<br />
–<br />
Widely distributed on the majority of epithelial cancers<br />
and hematological malignancies<br />
Expression and glycosylation different on normal vs.<br />
tumor epithelial cells<br />
Ongoing Phase III clinical trials:<br />
•<br />
•<br />
•<br />
START (NSCLC): started in Feb 2007. The study will recruit<br />
approximately 1,300 patients in more than 30 countries in around<br />
270 sites<br />
INSPIRE (NSCLC): started in Dec 2009. The study will recruit<br />
approximately 420 patients in Asia (China, Hong Kong, Singapore,<br />
South Korea, Taiwan)<br />
STRIDE (Breast Cancer): started in Jun 2009. The study will recruit<br />
more than 900 patients in over 30 countries in about 180 sites<br />
Page 54
<strong>Merck</strong> Serono<br />
Cilengitide<br />
Background:<br />
•<br />
•<br />
First in a new class of targeted anti-cancer therapies –<br />
known as integrin inhibitors<br />
The highly selective integrin inhibitor is thought to<br />
–<br />
–<br />
inhibit the formation of new blood vessels to the tumor<br />
directly target the tumor through blocking of survival<br />
and growth factors<br />
Ongoing Phase III clinical trial:<br />
•<br />
CENTRIC: (Glioblastoma multiforme) started in Nov 2008.<br />
The study will recruit approximately 500 patients in about 170 centers worldwide<br />
Ongoing Phase II studies:<br />
•<br />
•<br />
•<br />
•<br />
CERTO: in non-small cell lung cancer<br />
ADVANTAGE: in head and neck cancer<br />
CORE: Glioblastoma multiforme<br />
The US National Cancer Institute(NCI) is also sponsoring a number of clinical trials for the<br />
development of cilengitide in other indications.<br />
Page 55
<strong>Merck</strong> Serono<br />
Atacicept<br />
Novel Approach to Treat B-Cell Disorders<br />
Background:<br />
• A soluble fusion protein between the extracellular domain<br />
of the naturally occuring TACI receptor found on B-cells &<br />
the Fc portion of human IgG<br />
• Binds and neutralizes both BLyS and APRIL, TNF family<br />
cytokines implicated in B-cell differentiation and survival<br />
as well as antibody production<br />
Potential treatment for autoimmune diseases<br />
Atacicept (TACI-Ig)<br />
TACI<br />
BLyS/APRIL<br />
Binding<br />
Domain<br />
Human IgG Fc<br />
to extend t 1/2<br />
Update on Phase II / III trials:<br />
• Phase III:<br />
– APRIL (SLE): Phase III clinical trial in Systemic Lupus Erythematosus<br />
• Initiated in Jun 2008 and recruiting over 500 patients<br />
• Study will evaluate efficacy and safety compared to placebo in preventing SLE flares<br />
• Phase II:<br />
– Phase II trials in RA terminated early 2010: Decision not to move to Phase III due to insufficient<br />
clinical efficacy in order to develop a competitive product profile<br />
B-<br />
Cell<br />
TACI: Transmembrane Activator and Calcium modulator cyclophilin ligand Interactor<br />
Page 56
Consumer Health Care<br />
Focus on Defined Health Themes<br />
Consumer Health Care – Business Characteristics<br />
Mobility<br />
Everyday Health Protection<br />
Cough & Cold<br />
Women’s & Children’s Health<br />
Specialized in innovative products of defined Health Themes<br />
Page 57
Consumer Health Care<br />
Strengthening Strategy<br />
Marketing Strategy:<br />
Continue to focus on Strategic Brands/Health Themes.<br />
Build 7 strong, sustainable international strategic<br />
–<br />
–<br />
–<br />
–<br />
–<br />
–<br />
–<br />
Bion/Multibionta<br />
Flexagil (Seven Seas, Kytta)<br />
Femibion<br />
Nasivin<br />
Kidabion<br />
Cebion<br />
Diabion<br />
2)<br />
brands 1)<br />
Regional expansion of the Strategic Brands (Latam/Asia)<br />
Brand expansion:<br />
•<br />
•<br />
•<br />
Stretch product offer into relevant consumer benefit platforms (Innovation)<br />
Build brand awareness, usage and loyalty (Advertising)<br />
Ensure excellent in-market execution (POS/Promotion)<br />
1) Cebion, Diabion, Kidabion: regional Strategic Brands<br />
2) Includes strategic initiatives. Nasivin could attain power brand status under the assumption of a successful sinusitis in-licensing project<br />
Page 58
Liquid Crystals<br />
Specialty Chemical Solutions for<br />
Liquid Crystals – Market Characteristics<br />
•<br />
•<br />
•<br />
•<br />
•<br />
Specialty, tailor-made chemicals solutions<br />
Only one application: displays<br />
Highly consolidated competitive landscape with<br />
only three suppliers of liquid crystals<br />
<strong>Merck</strong> is leading the LC market since the beginning<br />
Display market dominated by five big Asian display<br />
customers in Japan, Korea and Taiwan<br />
Selected Applications<br />
LCD TV‘s<br />
Monitors<br />
Flat<br />
Displays<br />
Quarterly Business Development<br />
250<br />
200<br />
150<br />
100<br />
50<br />
0<br />
234<br />
119<br />
Q1<br />
2008<br />
238<br />
107<br />
Q2<br />
2008<br />
Operating Result Revenues<br />
239<br />
112<br />
Q3<br />
2008<br />
167<br />
52<br />
Q4<br />
2008<br />
Advertising space<br />
131<br />
13<br />
Q1<br />
2009<br />
189<br />
52<br />
Q2<br />
2009<br />
211<br />
72<br />
Q3<br />
2009<br />
in €m<br />
201<br />
91<br />
Q4<br />
2009<br />
Page 59
Liquid Crystals<br />
A Highly Consolidated Industry<br />
LC<br />
Suppliers<br />
LCD<br />
Panel<br />
Makers<br />
LCD<br />
Set<br />
Makers<br />
Page 60
Liquid Crystals<br />
TV Market by Unit Market Share<br />
Units Market share<br />
100%<br />
80%<br />
60%<br />
40%<br />
20%<br />
0%<br />
2 0 0 7 2 0 0 8 2 0 0 9 2 0 1 0 2 0 1 1 2 0 1 2 2 0 1 3<br />
LCD TV shipments surpassed CRT in 2008<br />
Source: DisplaySearch, Quarterly Global TV Shipment Report Q4/2009<br />
Other<br />
CRT<br />
Plasma<br />
LCD<br />
Page 61
Liquid Crystals<br />
Innovation in advanced LC materials<br />
Faster Response Time<br />
Better Contrast<br />
Improved Black State<br />
Liquid<br />
Crystals<br />
Faster Transmission<br />
Higher Reliability<br />
Better Viewing Angle<br />
Page 62
Liquid Crystals<br />
Innovation PS-VA & novel<br />
Technical superiority of PS-VA<br />
PS-VA technology cuts energy consumption and<br />
enhances picture quality, delivers faster response<br />
times, higher contrast ratio and higher transmission<br />
Fit for mass production<br />
Innovative materials and a specific mixture process<br />
have paved the way to mass production<br />
Solution driven<br />
Relentless innovation –<br />
budget<br />
funded from a generous R&D<br />
Applied research<br />
Synchronization of basic and application research<br />
Market centric<br />
Ongoing interdisciplinary development of creative<br />
solutions to satisfy future market needs<br />
LC Materials<br />
The "innolution" of LC materials<br />
for TV applications<br />
Innovation stimulates the development of future breakthrough products<br />
Page 63
Performance & Life Science Chemicals<br />
Serving across many attractive industries<br />
Academia<br />
Chemical<br />
Industry<br />
Laboratory Business<br />
Food &<br />
Beverage<br />
Pharma<br />
Biopharma<br />
Life Science Solutions<br />
Cosmetics<br />
Performance & Life Science Chemicals<br />
Coatings<br />
Pigments<br />
• Worldwide network of subsidiaries ensures customer proximity<br />
• Strong compentence in regulatory affairs to address regulated markets<br />
• Harmonized business processes in production, logistics and divisional services<br />
Printing,<br />
Plastics &<br />
Security<br />
Page 64
Performance & Life Science Chemicals<br />
Overview: Laboratory Business<br />
•<br />
•<br />
•<br />
•<br />
Academia<br />
Chemical Industry<br />
& Water Testing<br />
Laboratory Business<br />
Access to worldwide network of own subsidiaries and exclusive dealers ensuring customer proximity<br />
Serving approximately 1 million customers with more than 30,000 products<br />
Analytical competence and know-how for a broad range of applications<br />
Validated products and strong competence in regulatory affairs<br />
Inorganics<br />
& Solutions<br />
Solvents Chromatography Biosciences Microbiology,<br />
Hygiene &<br />
Microscopy<br />
Food &<br />
Beverage Pharma &<br />
Biopharma<br />
Food &<br />
Environmental<br />
Tests<br />
Lab Supply<br />
Page 65
Performance & Life Science Chemicals<br />
Overview: Life Science Solutions<br />
Pharma Biopharma Cosmetics<br />
Food<br />
Life Science Solutions<br />
Life Science Solutions serves the pharmaceutical, biopharmaceutical, cosmetics and food industry.<br />
The product portfolio covers:<br />
• Products and services for the entire value chain of biopharmaceutical production<br />
• Active ingredients used in oral or topical applications for pharma, cosmetics or food supplements<br />
• Biological crop-enhancing technologies in CropBioscience<br />
• Ionic liquids, a new technology platform used in a very broad technical area (i.e. catalysis)<br />
Page 66
Performance & Life Science Chemicals<br />
Overview: Pigments Business<br />
Coatings<br />
Coatings:<br />
•<br />
•<br />
Cosmetics<br />
Pigments Business<br />
Food & Pharma<br />
Printing, Plastics<br />
& Security<br />
Specialty effect pigments for automotive coating, powder coating, coil coating & decorative coating<br />
Functional pigments for UV protection, antiscratch and conductivity<br />
Cosmetics:<br />
•<br />
•<br />
Specialty effect pigments for color cosmetics, skinand personal care applications<br />
Functional pigments for cosmetic fillers<br />
Food & Pharma:<br />
•<br />
Specialty effect pigments for tablets, capsules, sweets, ice cream, beverages and coating systems<br />
Printing, Plastics & Security:<br />
•<br />
•<br />
Special effect pigments for packaging, paper coating, plastic masterbatch, ceramics & printing inks<br />
Functional pigments for laser marking, brand protection and high security solutions<br />
Page 67
Appendix<br />
Reconciliation to Core Figures<br />
Core operating result (€ million) 2009 2008 Δ in %<br />
Operating result 648.9 1,131.4 -42.6<br />
Amortization of intangibles 1 647.0 564.1 14.7<br />
Operating result generics - 0.4 …<br />
Restructuring/special integration costs Serono 0.0 39.2 …<br />
Core operating result 1,295.9 1,735.1 -25.3<br />
Core earnings per share (€ million) 2009 2008 Δ in %<br />
Net income (excl. generics in 2008) 376.7 379.5 -0.2<br />
Amortization of intangibles 1 647.0 564.1 14.7<br />
Restructuring/special integration costs Serono 0.0 39.2 …<br />
Exceptionals 28.0 400.0 -93.0<br />
Minority interest -10.4 -12.0 -13.3<br />
./. Tax adjustments -76.3 -125.9 -39.5<br />
Core net income 965.0 1,244.9 -22.5<br />
Core EPS 2 4.44 5.73 -22.5<br />
1 Only <strong>Merck</strong> Serono assets are considered.<br />
2 According to IAS 33 EPS is calculated on the weighted average number of shares (2009: 217.4 m; 2008: 217.4m).<br />
Page 68
Appendix<br />
Income Statement<br />
€ million 2009 2008 Δ in %<br />
Sales 7,377.7 7,201.6 2.4<br />
Royalty/commission income 369.2 388.0 -4.8<br />
SG&A -3,069.9 -2,744.5 11.9<br />
R&D -1,344.6 -1,234.4 8.9<br />
Amortization of intangibles -657.8 -573.4 14.7<br />
Operating result 648.9 1,131.4 -42.6<br />
Exceptionals -28.0 -400.0 -93.0<br />
EBIT 620.9 731.4 -15.1<br />
Financial result -134.5 -156.5 -14.1<br />
Profit before tax 486.4 574.9 -15.4<br />
Income tax -109.7 -195.9 -44.0<br />
Profit after tax 376.7 379.1 -0.6<br />
Minorities -10.4 -12.0 -13.5<br />
Net income 366.3 367.1 -0.2<br />
Earnings per share (€) 1 1.68 1.69 -0.6<br />
1 According to IAS 33 EPS is calculated on the weighted average number of shares (2009: 217.4m; 2008: 217.4m).<br />
Page 69
Appendix<br />
Costs<br />
€ million 2009 2008 Δ in %<br />
Sales 7,377.7 7,201.6 2.4<br />
Royalty income 369.2 388.0 -4.8<br />
Total revenues 7,747.0 7,589.6 2.1<br />
Cost of sales -2,029.3 -1906.0 6.5<br />
Gross margin 5,717.7 5,683.6 0.6<br />
Marketing & selling -2,272.3 -2,128.2 6.8<br />
Administration -424.9 -446.2 -4.8<br />
Other expenses/income -372.7 -170.1 ….<br />
R & D -1,344.6 -1.234.4 8.9<br />
Amortization of intangible assets -657.8 -573.4 14.7<br />
Investment result 3.4 0.1 …<br />
Operating result 648.9 1,131.4 -42.6<br />
Page 70
Investor Relations<br />
Upcoming Events<br />
Apr 9, 2010<br />
Apr 28, 2010<br />
Jul 29, 2010<br />
Oct 26, 2010<br />
DATE EVENT<br />
Annual General Meeting, Frankfurt<br />
Publication of business results for Q1 2010<br />
Conference Call<br />
Publication of business results for Q2 2010<br />
Conference Call<br />
Publication of business results for Q3 2010<br />
Conference Call<br />
More details can be found on: http://www.merck.de/en/investors/financial_calender/financial_calendar.html<br />
Page 71
Investor Relations<br />
Your Contact<br />
Dr. Markus Launer<br />
Head of Investor Relations<br />
Dr. Thomas Kornek<br />
+49 6151 72-7434<br />
Claudia Nickolaus<br />
+49 6151 72-2584<br />
Caroline Stewart<br />
+49 6151 72-5355<br />
Alessandra Heinz<br />
Assistant Investor Relations<br />
+49 6151 72-3744<br />
<strong>Merck</strong> <strong>KGaA</strong><br />
Investor Relations<br />
Frankfurter Str. 250<br />
64293 Darmstadt<br />
Germany<br />
Fax: +49 6151 72-913321<br />
investor.relations@merck.de<br />
www.investors.merck.de<br />
Page 72