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r This presentation contains certain forward-looking statements. - - PowerPoint PPT Presentation

Dec 28, 2023 450 likes •763 views

r This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as believes, expects, anticipates, projects, intends, should, seeks,

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This presentation contains certain forward-looking statements. These forward-looking statements may be identified by words such as “believes”, “expects”, “anticipates”, “projects”, “intends”, “should”, “seeks”, “estimates”, “future” or similar expressions or by discussion of strategy, goals, plans or intentions. Various factors may cause actual results to differ materially in the future from those reflected in forward-looking statements contained in this presentation among others: (1) pricing and product initiatives of competitors; (2) legislative and regulatory developments and economic conditions; (3) delay or inability in obtaining regulatory approvals or bringing products to market; (4) fluctuations in currency exchange rates and general financial market conditions; (5) uncertainties in the discovery, development or marketing of new products

  • r new uses of existing products; (6) increased government pricing pressures; (7)

interruptions in production; (8) loss of or inability to obtain adequate protection for intellectual property rights; (9) litigation; (10) loss of key executives or other employees; and (11) adverse publicity or news coverage.

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Pharmaceuticals Division

William M. Burns

Head of Pharmaceuticals Division

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Pharmaceuticals sales (adjusted)

Roche world wide Prescription group1,2 17,754 3 % 10 % OTC 1,552

  • 7 %
  • 2 %

Pharmaceuticals1 19,306 2 % 9 %

2002 growth vs. growth vs. 2001 CHF m 2001 in CHF in local currencies

1 sales are adjusted to include the reclassification of sales to the Vitamins and Fine Chemicals Division 2 Roche, Genentech and Q4 sales of Chugai combined

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Pharmaceuticals score card 2002

Fulfilling the promises

stated objectives actual 2002*

  • Sales growth

mid-single digit 5 % / 9 % incl. Chugai

  • EBITDA margin

stable up 1.3 pp to 31.0 %

  • Operating profit margin

stable up 1.6 pp to 21.1 %

  • Product portfolio

strengthening +19 NME's

  • Pegasys

combo NDA filing US ! approval EU !

  • Fuzeon

clinical phase III results !

  • MabThera

launch of aNHL in EU !

  • Xenical

continued single digit growth " (-16 %)

* local currency

1 new drug application of Pegasys in combination with Copegus in hepatitis C virus infection 2 aggressive non-Hodgkin's lymphoma

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Pharmaceuticals

Further achievements 2002

  • Significant product launches in EU

– MabThera in aggressive non-Hodgkin's lymphoma (aNHL) – Valcyte in Cytomegalo virus (CMV) infection in AIDS patients – Xeloda in combination in metastatic breast cancer (mBC) – Pegasys in combination with Copegus in hepatitis C virus (HCV) patients

  • Kytril back on growth track
  • 25 licensing deals of which 9 product deals
  • More than 44 successful regulatory inspections of manufacturing sites
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15 % local

7 % CHF

17 %

8 %

5,982 5,603 3,674 4,082 5,694 5,256 3,389 3,838 288 347 285

244

  • 12 %
  • 17 %

21 %

11 %

23 %

13 %

Pharmaceuticals Prescription1 OTC2

  • 9 %
  • 14 %

2001

2002

2002 profit growth - Pharmaceuticals (adjusted)

Over 20 %* operating profit increase

CHF m EBITDA

  • perating

profit

1 Roche, Genentech and Q4 sales of Chugai combined 2 Roche OTC only (without Chugai OTC)

* local currency

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19.7 21.6 19.5 21.1 17.2 15.7 Pharmaceuticals Prescription1 OTC2 29.7

  • perating profit

as % of sales

20.9 31.0 32.1 18.6

EBITDA as % of sales

30.6 2002 2001

Pharmaceuticals margin expansion (adjusted)

Targeting towards 25 % by end of 2004

1 Roche, Genentech and Q4 sales of Chugai combined 2 Roche OTC only (without Chugai OTC)

* local currency

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sales of top 10 products

0.5 1 1.5 2 2.5 Xeloda Kytril Nutr/Protr Xenical Roacc Herceptin CellCept NeoRec Rocephin MabThera CHF billion

2002 major growth drivers

Multiple one-billion products

2.3 (+48 %) 1.5 (-2 %) 1.2 (+32 %) 1.2 (+18 %) 1.0 (+33 %) 0.9 (-16 %) 0.8 (-16 %)

all at local growth rates

sales of top 10 products as % of Prescription 51 58 55

0% 10% 20% 30% 40% 50% 60% 70% 2000 2001 2002

0.5 (+19 %) 0.5 (+12 %) 0.4 (+82 %)

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Proteins and antibodies

Roche group - the second biggest biotech company

% of Prescription sales

1 2 3 4 5 6 7 2000 2001 2002 CHF billion

  • Relatively high market entry barriers
  • Strong profit generators
  • 12 products with significant medical

differentiation

  • Relatively low promotional effort

required

24 % 25 % 36 %

sales 3.8 4.3 6.3

CHF billion

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Patent expiry 2002 - 2006

Strong patent protected portfolio

2 5 10 12 12 13 13 15 18 18 22 31 33 34 35 40 41 56 69

16

0% 25% 50% 75%

Amgen S-P Bayer Sanofi Pfizer BMS Takeda MSD Wyeth GSK Novartis Roche Lilly Abbott AZN BI Aventis J&J Pharmacia Esai

Roche

source: IMS health MAT Sept 2002

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2002 Prescription* sales

Strong growth in US, Japan and in key franchises

8 % 9 % 33 % 9 % 41 % Western Europe +4 % North America +10 %

  • thers +7 %

Japan +82 %

Latin America -11 %

29 % 5 % 7 % 7 % 9 % 10 % 33 %

infectious disease -6 %

  • ncology

+33 % cardiovascular +8 %

  • ther -5 %

transplant +16 % anemia +79 % all growth figures are in local currencies * Roche, Genentech and Q4 sales of Chugai combined virology + 3%

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Oncology - Roche the no. 1 company

Outperforming the market

500 1000 1500 2000 2500

Furtulon Bondronat Roferon-A (60 %) Neupogen NeoRec (25 %) Kytril Xeloda Herceptin MabThera

CHF m 2001 2002

  • Long patent protection
  • Additional opportunities with

Tarceva, Avastin, Bondronat, Pemtumomab

  • Rich pipeline targeting major

tumor types

  • Expected to further increase, from

CHF > 5 billion (2002) to CHF 6 - 8 billion (2005)

sales growth +33 %1

1 local growth

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14 500 1'000 1'500 2'000 2'500 3'000 3'500 1999 2000 2001 2002 peak sales

MabThera - ongoing success

First choice in aggressive and indolent NHL

  • Growth drivers for both NHL

– Roche (ex-US) market penetration: iNHL ~20 %, aNHL ~25 % – increase penetration – earlier and longer treatment

  • Future growth / opportunities

– maintenance (data presented Dec '02) and re-treatment – MabThera in RA (phase IIb data expected 2004 / 2005) – move into first line iNHL (currently 3rd line), filing planned for 2006 – MabThera in CLL (phase III, filing expected 2008)

CHF m

global (Roche & Genentech & Chugai) +48 %1

1 local growth

new up to 3,500

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Herceptin

Targeted on HER2, focused on living

  • Growth drivers

– increased testing – expansion in 1st line usage and duration of treatment

  • Future growth

– filing of 1st line treatment Herceptin + Docetaxol expected H2 '03 – Herceptin monotherapy in mBC 3-weekly regimen, filing expected H2 '03 – development of adjuvant indication by 2009 (interim data 2005)

200 400 600 800 1'000 1'200 1'400 1999 2000 2001 2002 peak sales

CHF m

+33 %1 global (Roche & Genentech & Chugai)

1 local growth

up to 1,500

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Xeloda

The powerful, yet gentle chemotherapy

  • Growth drivers

– global market penetration ~ 15 % for mBC and mCRC – steadily replace i.v. 5-FU/LV in mCRC – expanding use in mBC in combination (1st line in combo with taxanes)

  • Future growth

– development as 1st line in mCRC – mCRC and mBC- 6 Phase III studies initiated to establish Xeloda as combination therapy in adjuvant and neo-adjuvant treatment

100 200 300 400 500 1999 2000 2001 2002 peak sales

CHF m

+82 %1 global (Roche & Chugai)

1 local growth

  • ver

1,500

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sales 100 200 300 400 500 Hivid Inivirase / Fortovase Viracept Tamiflu Pegasys

2001 2002

Virology

Strong commitment retained

sales growth +3 %1

1 local growth

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1 Fried MW et al. N Engl J Med. 2002;347(13):975-82 2 Hadziyannis SJ. EASL Annual Meeting 2002

Pegasys and Copegus

Strong clinical data

  • Pegasys sales of CHF 94 million in the 1st year of launch
  • Associated with improved tolerability1

– lower incidence of depression and flu-like symptoms

  • Shorter treatment duration associated with fewer SAE's and

withdrawals2

  • Low-dose Copegus is associated with2:

– fewer SAE's (24 weeks) – fewer Copegus dose modifications – fewer serious decreases in hemoglobin

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Pegasys

Rapid market share gains

months from launch 6 5 4

Pegasys 23 % 50 % 50 % 70 %

Brazil / Mexico / Switzerland Germany Austria USA

(new scripts)

2 3

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Pegasys

Strategic initiatives for future growth

  • Data for patients with normal ALT - to be presented end 2003
  • Data in HIV / HCV co-infection - to be presented H1 '04
  • Data in HBV - 2 studies - to be presented in 2004
  • Pre-filled syringes for US
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Fuzeon

Active against current strains of drug resistant HIV-1

  • Targeted for ~ 30 % of patients (3rd line)
  • Priced in Europe at Euro 52 per daily treatment
  • > 90 % of patients found self injection of Fuzeon "very easy",

"easy" or "neutral"

  • Filings

– US: September 17th '02, EU: September 20th '02

  • Production capacity

– end of '03: 20,000 production capacity; 12,000 - 15,000 patients – end of '04: 39,000 production capacity; 32,000 patients – end of '05: 39,000 production capacity; 39,000 patients

  • Expected approval H1 '03
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CellCept

A cornerstone of transplant therapy

  • Growth drivers

– market share for new patients (up to 6 months post-transplant) ~ 65 % of all transplants – penetration of the existing patient pool by switching patients to CellCept – market share for longer term patients

  • n treatment (over 6 months post-

transplant) ~ 57 % in indicated SOT*

  • Future growth

– emphasis from acute rejection to protecting organs and patients for long term

200 400 600 800 1'000 1'200 1'400 1999 2000 2001 2002 peak sales

CHF m

+18 %1 global (Roche & Chugai) * solid organ transplant

1 local growth

  • ver

1,500

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NeoRecormon

A CHF 2 billion drug on growth track

  • Market dynamics: (EU only)

– oncology: growth +54 %, 25 % market share (+3 pp) – renal: growth +20 %, 45 % market share (+2 pp)

  • Japan (Chugai)

– + CHF 800 million sales* (2002 base)

  • PRCA

– low current awareness in oncology but growing → opportunity

  • Once weekly dosing

– driver for growth in oncology

200 400 600 800 1'000 1'200 1999 2000 2001 2002

NeoRecormon Epogin

CHF m

+67 %1 global (Roche & Chugai)

1 local growth

* at fx rate of ¥ 100 = CHF 1.30

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EPO franchise

New exciting opportunities

  • CERA

– strategic fit with NeoRecormon – possible market entry into all key markets – development objectives # better local tolerability # reduced injection frequencies # superior formulation – phase II ongoing, data could be available beginning of 2004

  • SEP

– in-licensed from Gryphon in 2002 – planned to enter phase I in 2003

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5 3 2 13 5 4 4 8 16

Research Development

60 projects including 40 NME's*

* new molecular entities prior to regulatory approval

1 as of January 31, 2003

CNS metabolic anaemia respiratory transplantation genitourinary viral inflammatory

  • ncology

37 30 24 9 17 8 10

135 projects genitourinary vascular viral metabolic

  • ncology

inflammatory CNS

R&D pipeline overview1)

By therapy area

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Roche R&D pipeline today

Total of 65 NME’s including 9 opt-in opportunities

phase 0 phase I phase ll phase III / registration

Roche pipeline status on January 31, 2003

Roche managed

  • pt-in opportunities

Antisoma (At) Axovan (Ax) Basilea (B) Speedel (S) participation through Genentech participation through Chugai Raptiva Xolair

R701 overactive bladder R411

asthma

R667

emphysema

R673 R1461

HPV

R1524

renal transplant

R1273

solid tumors

R724

(T-1249) HIV

R450 R483 R744 R484 R698

(Fuzeon) HIV

R1415 (Tarceva) oncology

Avastin (oncology)

R944

HIV

R1067

depression

R1124

emesis

R1295

asthma

R1453

solid tumors

R1440

type 2 diabetes

R1438

type 2 diabetes

R1439

type 2 diabetes

(alpha 1 agonist) stress incontinence (insulin sensitizer) type 2 diabetes (next generation anaemia treatment) (NK1) depression/anxiety

R1479

HCV

R1533

Alzheimer’s acute coronary syndrome

R1516

anaemia treatment

R1495

HIV

R1518

HCV

R1454

solid tumors

R1484

stress incontinence

R1503

rheumatoid arthritis

R1068

emesis antifungal (B) antifungal (B)

R1554

OAB

Bonviva

  • steoporosis

R1549 R1270

HCV

R1487

rheumatoid arthritis

R1204

depression/anxiety

R1492

solid tumors

R1550

breast cancer antibiotic (B) solid tumors (At) lung cancer (At)

(Pemtumomab)

  • varian cancer
  • steoporosis

multiple myeloma macular degeneration psoriasis (B) eczema (B)

  • inflamm. bowel disease

cardiovascular disease (S)

subarachnoid hemorrhage (Ax)

bone metastases gastroparesis

  • steoporosis

rheumatoid arthritis CHD post hepatectomy subarachnoid hemorrhage breast cancer

R1559

solid tumors

R1536

solid tumors

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Substantial opportunities (NME's only)

Decisions will be taken on 14 projects over next 12 months

phase action time

Bonviva III database closure H2 '03 MabThera in RA III start of recruitment H1 '03

(TNF failure)

Tarceva III 1st line NSCLC data available H2 '03 Avastin III CRC study data available H2 '03 R1549 III

  • varian cancer study data available

H2 '03 MRA (Chugai) III start of study H2 '03 MabThera in RA IIb start of study H1 '03 R483 II data available H2 '03 R744 II data available H2 '03 R673 II (US) recruitment finished H2 '03 R411 II recruitment finished H2 '03 R450 II recruitment finished H2 '03 R1273 II BC mono, recruitment finished H2 '03 T-1249 II start of study H1 '03

decisions taken

  • n phase III

decisions taken

  • n phase II
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NDA filing dates

2003 – 2007

Xenical adolescent

  • besity

NeoRecormon pre-filled syringe, EU Herceptin MBC 1st line combo Tarceva NSCLC Xeloda

  • adj. colon

cancer monoTx Pegasys HBV Bonviva

  • steoporosis

i.v. & oral formul. R1549

  • varian cancer

MabThera RA TNF-failures R1461 RRP R212 2nd gen. obesity new formulation Levovirin HCV R483 type 2 diabetes R673 depression Xeloda 1st & 2nd line MCRC combo Herceptin MBC hormonal R744 renal & cancer anemia R1124 emesis R724 HIV/AIDS MabThera 1st line iNHL, EU R450 urinary stress incontinence R212 2nd gen. obesity (GINCA) R944 HIV/AIDS R411 asthma MabThera RA signs, symptoms & struct. damage R1461 genital warts Xeloda

  • adj. colon cancer

combo Herceptin adjuvant BC R1273 solid tumors

2004 2005 2007 2006 2003

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Our growth objectives for 2003 and beyond

Pharmaceuticals

2003

  • Double-digit sales growth*
  • Double-digit operating profit growth*

and beyond

  • Operating profit margin: towards 25 % by end of 2004

* local currency

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