William M. Burns CEO Division Roche Pharmaceuticals
William M. Burns CEO Division Roche Pharmaceuticals
William M. Burns CEO Division Roche Pharmaceuticals
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Annual Media Conference<br />
1 February 2006<br />
<strong>William</strong> M. <strong>Burns</strong><br />
<strong>CEO</strong> <strong>Division</strong> <strong>Roche</strong> <strong>Pharmaceuticals</strong><br />
1
2005: Record sales and record profit<br />
• Pharma organic growth four times faster than world market<br />
– top ten products +32%<br />
– top twenty products +31%<br />
• Strong operating profit development and improved quality of<br />
earnings<br />
• Successful launch of seven new products/indications<br />
• Outstanding clinical data in oncology<br />
• Four phase III trials for CERA in renal anemia – maintenance<br />
successfully completed<br />
• Built the base for entry into a new therapeutic franchise of<br />
autoimmune diseases<br />
2
Sales 2005<br />
<strong>Roche</strong> significantly outgrowing the market<br />
2004 2005 % change in % USD<br />
CHF m CHF m CHF local growth<br />
<strong>Pharmaceuticals</strong> 21,695 27,268 26 25 25<br />
<strong>Roche</strong> Pharma 13,970 16,955 21 20 21<br />
Genentech 4,522 6,614 46 46 46<br />
Chugai 3,203 3,699 15 17 15<br />
3
2005: <strong>Pharmaceuticals</strong> operating profit 1<br />
Margin increase driven by all sub-divisions<br />
25.0%<br />
CHF m<br />
27.4%<br />
+37 % 2<br />
(+37 %)<br />
7,463<br />
26.0%<br />
26.8%<br />
29.0%<br />
32.1%<br />
15.2%<br />
21.5%<br />
% of sales<br />
5,432<br />
+24 % 2<br />
(+25 %)<br />
3,632<br />
4,542<br />
2004 2005<br />
1,313<br />
+62 % 2<br />
(+62 %)<br />
2,124<br />
487<br />
+68 % 2<br />
(+64 %)<br />
797<br />
Pharma <strong>Division</strong> <strong>Roche</strong> Pharma Genentech Chugai<br />
1<br />
Before exceptional items 2<br />
At constant exchange rates<br />
4
Top 10 prescription products<br />
Strategic products account for over 70% of the sales<br />
Total<br />
MabThera/Rituxan<br />
NeoRecormon/Epogin<br />
Herceptin<br />
CellCept<br />
Avastin<br />
Tamiflu<br />
Pegasys<br />
Rocephin<br />
Xeloda<br />
Xenical<br />
CHF m<br />
4,154<br />
2,252<br />
2,146<br />
1,705<br />
1,665<br />
1,558<br />
1,403<br />
927<br />
796<br />
635<br />
local<br />
22%<br />
8%<br />
48%<br />
20%<br />
141%<br />
370%<br />
17%<br />
-29%<br />
47%<br />
5%<br />
5
Sales of other “new” products<br />
Global<br />
US<br />
Japan<br />
Europe/RoW<br />
CHF m<br />
% loc<br />
CHF m<br />
% loc<br />
CHF m<br />
% loc<br />
CHF m<br />
% loc<br />
Xolair<br />
408<br />
74<br />
408<br />
74<br />
-<br />
-<br />
-<br />
-<br />
Tarceva<br />
387<br />
2224<br />
342<br />
1959<br />
-<br />
-<br />
45<br />
-<br />
Fuzeon<br />
259<br />
53<br />
133<br />
29<br />
-<br />
-<br />
126<br />
91<br />
Raptiva<br />
117<br />
67<br />
117<br />
67<br />
-<br />
-<br />
-<br />
-<br />
Evista<br />
104<br />
182<br />
-<br />
-<br />
104<br />
182<br />
-<br />
-<br />
Boniva/Bonviva<br />
86<br />
-<br />
82<br />
-<br />
-<br />
-<br />
4<br />
-<br />
Renagel<br />
57<br />
28<br />
-<br />
-<br />
57<br />
28<br />
-<br />
-<br />
6
9 key brands providing strong organic growth<br />
Representing 55% of portfolio<br />
60%<br />
50%<br />
40%<br />
30%<br />
20%<br />
10%<br />
0%<br />
% of pharmaceutical sales<br />
2%<br />
7%<br />
6%<br />
5%<br />
2%<br />
3% 6%<br />
3% 3%<br />
6% 6%<br />
7%<br />
7%<br />
8%<br />
7%<br />
10% 10% 8%<br />
14 %<br />
15 %<br />
15%<br />
2003 2004 2005<br />
CHF m<br />
4500<br />
4000<br />
3500<br />
3000<br />
2500<br />
2000<br />
1500<br />
1000<br />
500<br />
0<br />
86<br />
370<br />
975<br />
262<br />
302<br />
711<br />
248<br />
170<br />
776<br />
Growth vs 2004<br />
Boniva/Bonviva<br />
Tarceva<br />
Avastin<br />
Xeloda<br />
CellCept<br />
Herceptin<br />
Pegasys/<br />
Copegus<br />
NeoRecormon/<br />
Epogin<br />
MabThera/<br />
Rituxan<br />
~ CHF 3.9 bn additional sales<br />
(~ CHF 5.1 bn including Tamiflu)<br />
7
Tamiflu<br />
Meeting the challenges<br />
• Working with governments to stockpile Tamiflu for pandemic use.<br />
Over 60 governments placed orders, covering 25–40% of population<br />
• Scaling up manufacture 10 fold compared to 2002<br />
• Identifying partners to further strengthen <strong>Roche</strong> production network<br />
• Sub-licensing agreements with Hetero (India) and Shanghai<br />
<strong>Pharmaceuticals</strong> (China)<br />
• Donation of 5 million treatment courses to WHO: 3 million as rapid<br />
response stockpile and 2 million for regional stockpiles<br />
• Approval for prevention of influenza in children (USA and Europe)<br />
8
Tamiflu<br />
Outlook 2006<br />
• Work with governments to increase number stockpiling<br />
Tamiflu and increasing the population coverage<br />
• 20+ projects to ensure annual production output of more<br />
than 300 million treatments<br />
• Work with third parties to<br />
– Monitor neuraminidase inhibitor resistance<br />
– Gain further insights into the efficacy of Tamiflu in H5N1<br />
• Establish Tamiflu as the therapy of choice<br />
for the treatment and prevention of<br />
seasonal influenza<br />
9
2005: <strong>Pharmaceuticals</strong> <strong>Division</strong><br />
Market outperformance in key regions<br />
North America<br />
+32%<br />
(IMS +6%)<br />
40%<br />
Prescription +25%<br />
(IMS +6%)<br />
Europe*<br />
+23%<br />
(IMS +7%)<br />
14%<br />
32%<br />
Japan<br />
+17%<br />
(IMS +20%)<br />
Latin America<br />
+20%<br />
(IMS +20%)<br />
8 %<br />
6%<br />
others<br />
+15%<br />
All growth figures are in local currencies<br />
* Including Eastern Europe<br />
10
Growth in main therapeutic areas<br />
Anemia +5%<br />
Transplant +19%<br />
8%<br />
6%<br />
Virology +62%<br />
15%<br />
Others +13%<br />
21%<br />
6% 4% 40%<br />
Cardiovascular<br />
-2%<br />
Oncology +42%<br />
Infectious diseases -25%<br />
All growth figures are in local currencies<br />
11
<strong>Roche</strong> R&D pipeline today<br />
R1599<br />
R1511<br />
R1579<br />
R1664<br />
R1646<br />
R1450<br />
R641<br />
R1647<br />
R7118<br />
R1507<br />
R1206<br />
R7025<br />
R7128<br />
MED<br />
phase 0<br />
(14 NMEs)<br />
osteoarthritis<br />
type 2 diabetes<br />
type 2 diabetes<br />
dyslipidemia<br />
OAB<br />
Alzheimer‘s<br />
Alzheimer's<br />
depression<br />
schizophrenia<br />
solid tumors<br />
HIV<br />
HCV<br />
HCV<br />
HIV<br />
NME (New Molecular Entity)<br />
R <strong>Roche</strong> managed projects<br />
A Participations<br />
A Opt-in Opportunities<br />
AI (Additional Indication)<br />
R <strong>Roche</strong> managed projects<br />
A Participations<br />
A Opt-in Opportunities<br />
CHU<br />
GEN<br />
ANT<br />
IPS<br />
ISO<br />
MED<br />
MEM<br />
ARQ<br />
Chugai<br />
Genentech<br />
Antisoma<br />
Ipsen<br />
Isotechnika<br />
Medvir<br />
Memory<br />
ArQule<br />
Status as of December 31, 2005<br />
phase I<br />
(21 NMEs + 4 Als)<br />
R1541<br />
IBD<br />
R1295<br />
RA<br />
R3421<br />
AI / transplant<br />
R1439<br />
type 2 diabetes<br />
R1593<br />
dyslipidemia<br />
R1678<br />
schizophrenia<br />
R7090<br />
anxiety<br />
R1550<br />
mBC<br />
R547<br />
solid tumors<br />
R1454<br />
solid tumors<br />
R1530<br />
solid tumors<br />
R1645<br />
solid tumors<br />
R1626<br />
HCV<br />
R1656<br />
HCV<br />
CHU<br />
solid tumors<br />
GEN<br />
cancer<br />
GEN diabetic foot ulcers<br />
GEN<br />
RA<br />
GEN basalcellcarcinoma<br />
ARQ<br />
solid tumors<br />
MEM<br />
Alzheimer's<br />
R127 Valganciclovir ulcerat. colitis<br />
R1594<br />
hematological tumors<br />
R35 Daclizumab transpl. maint.<br />
GEN Raptiva adult atopic derma.<br />
Total of 59 NME's +<br />
49 Additional Indications<br />
phase II<br />
(19 NMEs + 9 Als)<br />
R1558 bacterial infections<br />
R1503<br />
RA<br />
R1594<br />
RA<br />
R1440<br />
type 2 diabetes<br />
R483<br />
type 2 diabetes<br />
R1438<br />
type 2 diabetes<br />
R1658<br />
dyslipidemia<br />
R873<br />
MED<br />
R1273<br />
ovarian cancer<br />
R1492<br />
solid tumors<br />
R667<br />
emphysema<br />
R411<br />
asthma<br />
CHU<br />
gastroparesis<br />
CHU<br />
bone metastasis<br />
CHU<br />
osteoporosis<br />
CHU<br />
post-hepatectomy<br />
ANT<br />
solid tumors<br />
ISO<br />
renal transplant<br />
IPS<br />
type 2 diabetes<br />
R744 CERA cancer anaemia<br />
R435 Avastin squamous NSCLC<br />
R1415 Tarceva glioblastoma<br />
R1273<br />
mBC<br />
R35 Daclizumab asthma<br />
GEN Avastin adj. BC<br />
GEN Avastin glioblastoma<br />
GEN MabThera RRMS<br />
GEN MabThera lupus nephritis<br />
phase III/filed<br />
(5 NMEs + 36 Als)<br />
R744 CERA renal anaemia<br />
R1569 Actemra RA<br />
GEN Lucentis AMD<br />
CHU Antevas subarach haemor.<br />
CHU ED-71 osteoporosis<br />
R1569 Actemra sJIA<br />
R99 CellCept lupus nephritis<br />
R99 CellCept myastenia gravis<br />
R105 MabThera RA TNF nonresp<br />
R105 MabThera RA DMARD nonr.<br />
R105 MabThera CLL 1st line<br />
R105 MabThera CLL relapsed<br />
R105 MabThera maint. iNHL<br />
R1415 Tarceva pancreatic ca<br />
R1415 Tarceva NSCLC 1st line<br />
R1415+R435 T+A NSCLC 2nd line<br />
T+A NSCLC 1st line maint.<br />
R340 Xeloda mCRC combo 1st<br />
R340 Xeloda mCRC combo 2nd<br />
R340 Xeloda adj. CC combo<br />
R340 Xeloda adj. BC<br />
R435 Avastin adj. CC<br />
R435 Avastin mBC<br />
R435 Avastin+Xeloda mBC<br />
R435 Avastin pancreatic ca<br />
R435 Avastin RCC<br />
R435 Avastin NSCLC<br />
R435 Avastin prostate ca<br />
R435 Avastin ovarian cancer<br />
R435 Avastin 1st line mCRC ext.<br />
R597 Herceptin adj. BC<br />
R597 Herceptin mBC combo<br />
R597 Herceptin gastric ca<br />
R925 Bondronat MBP<br />
GEN Xolair ped. asthma/allergy<br />
CHU Epogin cancer anaemia<br />
CHU Sigmart acute heart fail.<br />
CHU Femara breast cancer<br />
GEN MabThera PPMS<br />
GEN MabThera ANCA a. vascul.<br />
GEN MabThera SLE<br />
R1415+R435<br />
12
<strong>Pharmaceuticals</strong>: Our objectives for 2006<br />
Another busy year…<br />
r<br />
Compound<br />
Phase<br />
Indication<br />
Data<br />
Filings Major clinical data<br />
R744 (CERA)<br />
CellCept<br />
Herceptin<br />
Xeloda<br />
Avastin<br />
Avastin / Xeloda<br />
R1658<br />
R873<br />
Avastin / Tarceva<br />
R1594<br />
Compound<br />
R744 (CERA)<br />
Avastin<br />
Avastin<br />
Avastin<br />
Herceptin<br />
III<br />
III<br />
III<br />
III<br />
III<br />
III<br />
II<br />
IIa<br />
II<br />
II<br />
Indication<br />
Renal anemia (correction)<br />
Lupus nephritis (Induction phase)<br />
mBC combo hormonal (TAnDEM)<br />
mCRC 2nd line<br />
NSCLC 1st line (AVAIL)<br />
mCRC 1st line combo extension<br />
Dyslipidemia<br />
MED<br />
NSCLC 2nd line<br />
RA<br />
Renal anemia<br />
NSCLC 1st line<br />
mBC 1st line<br />
mCRC 1st line combo extension<br />
Adjuvant BC<br />
Final<br />
Final<br />
Final<br />
Final<br />
Interim + Final<br />
Final<br />
Final<br />
Final<br />
Final<br />
Final<br />
<strong>Division</strong>al sales<br />
growth<br />
Double-digit growth<br />
in local currencies<br />
Herceptin<br />
mBC combo hormonal<br />
Xeloda<br />
mCRC 1st line combo<br />
Barring unforeseen events<br />
13
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