amgen: the leader in nephrology - iis windows...

Amgen: The Leader in NephrologyHelen TorleyVice President and General Manager, Nephrology Business UnitRobert M. Brenner, MD Executive Director, Global Development

November 4, 2007

Provided November 4, 2007 as part of an oral presentation and is qualified by such,contains forward-looking statements, actual results may vary materially;Amgen disclaims any duty to update.

Safe Harbor StatementThis presentation contains forward-looking statements that are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described. All statements, other than statements of historical fact, are statements that could be deemed forward-looking statements, including estimates of revenues, operating margins, capital expenditures, cash, other financial metrics, expected legal, arbitration, political, regulatory or clinical results and other such estimates and results. Forward-looking statements involve significant risks and uncertainties, including those discussed below and more fully described in the Securities and Exchange Commission (SEC) reports filed by Amgen, including Amgen’s most recent annual report on Form 10-K and most recent periodic reports on Form 10-Q and Form 8-K. Please refer to Amgen’s most recent Forms 10-K, 10-Q and 8-K for additional information on the uncertainties and risk factors related to our business. Unless otherwise noted, Amgen is providing this information as of November 4, 2007 and expressly disclaims any duty to update information contained in this presentation.No forward-looking statement can be guaranteed and actual results may differ materially from those we project. The Company’s results may be affected by our ability to successfully market both new and existing products domestically and internationally, sales growth of recently launched products, difficulties or delays in manufacturing our products and regulatory developments (domesticor foreign) involving current and future products and manufacturing facilities. We depend on third parties for a significant portion of our Enbrel® (etanercept) supply and limits on supply may constrain ENBREL sales. In addition, sales of our products are affected by reimbursement policies imposed by third-party payers, including governments, private insurance plans and managed care providers and may be affected by domestic and international trends toward managed care and health care cost containment as well as U.S. legislation affecting pharmaceutical pricing and reimbursement. Government regulations and reimbursement policies may affect the development, usage and pricing of our products. Furthermore, our research, testing, pricing, marketing and other operations aresubject to extensive regulation by domestic and foreign government regulatory authorities. We or others could identify side effects or manufacturing problems with our products after they are on the market. In addition, we compete with other companies with respect to some of our marketed products as well as for the discovery and development of new products. Discovery or identification of new product candidates cannot be guaranteed and movement from concept to product is uncertain; consequently, there can be no guarantee that any particular product candidate will be successful and become a commercial product. In addition, while we routinely obtain patents for our products and technology, the protection offered by our patents and patent applications may be challenged, invalidated or circumvented by our competitors. Further, some raw materials, medical devices and component parts for our products are supplied by sole third-party suppliers. Our business may be impacted by government investigations, litigation and product liability claims.This presentation includes GAAP and non-GAAP financial measures. In accordance with the requirements of SEC Regulation G, reconciliations between these two measures, if these slides are in hardcopy, accompany the hardcopy presentation or, if these slides are delivered electronically, are available on the Company's website at www.amgen.com within the Investors section.


Presentation Overview

Overview of our Nephrology Business

Strategies for growth

Amgen Nephrology clinical update

ASN highlights

Helen TorleyVice President and General Manager

Nephrology Business Unit

Robert Brenner, MDExecutive Director

Global Development


3%

3%

4%

8%

8%

10%

15%

40%

0% 5% 10% 15% 20% 25% 30% 35% 40% 45%

Novartis

Roche

Pfizer

Fujisawa/Astellas

Ortho-Biotech

Genzyme

Baxter

Amgen

Percent of Nephrologists

Amgen Is Recognized as the Clear Leader in Nephrology

2%2%2%

3%4%

6%7%

9%12%

16%33%

0% 5% 10% 15% 20% 25% 30% 35%

Bristol-Myers Squibb

Merck

Sanofi-Aventis

Genzyme

Fujisawa/Astellas

Baxter

Roche

Ortho-Biotech

Pfizer

Novartis

Amgen


Amgen Is Considered the Best Role Model in Nephrology

Nephrologists Consider Amgen as the Company With the Greatest Innovation to Date

Nephrologists View Amgen as the Company With the Greatest Potential for Future Innovation

Nephrologists View Amgen as the Company With the Greatest Patient Focus

5%

6%

10%

10%

12%

15%

33%

0% 5% 10% 15% 20% 25% 30% 35%

Fujisawa/Astellas

Baxter

Genzyme

Novartis

Genentech

Roche

Amgen


4%

4%

5%

5%

6%

6%

8%

54%

0% 10% 20% 30% 40% 50% 60%

Fujisawa/Astellas

Ortho-Biotech

Pfizer

Abbott Labs

Baxter

Novartis

Genzyme

Amgen


Source: MMRx Image Study, 6/07, N = 100 nephrologists.


EPOGEN® Q3 Results Reflect Impactof March Label Revision

$ Millions, Net SalesKey Drivers

$604 $613 $633$602

$661$624$625

0

100

200

300

400

500

600

700

Q1 ’06 Q2 ’06 Q3 ’06 Q4 ’06 Q1 ’07 Q2 ’07 Q3 ’07

EPOGEN® sales decline of 5% versus the third quarter of the prior year

– Primarily driven by a decline in dose/utilization and increased discounts, partially offset by patient population growth

Physicians have continued to evaluate the final NKF KDOQI™guidelines, revised labeling, and pending EMP update (Jan ’08 implementation) in making treatment and dosing decisions

EMP = erythropoietin monitoring policy.NKF KDOQI™ = National Kidney Foundation Kidney Disease Outcomes Quality Initiative.KDOQI™ is a trademark of the National Kidney Foundation, Inc.


Important EPOGEN® Events Are Ongoing

Key Events Status

peg-EPO patent trial Patents upheld

ESA labeling Ongoing

EMP update January 2008 implementation

Reimbursement changes Ongoing


Aranesp® Continues to Be the Leader in Nephrology Clinics

Aranesp® Nephrology Clinic Share 62%Aranesp® Non-Oncology Share of Gross Sales by Segment

Note: Share of sales based on non-dialysis Epoetin alfa and a rolling 4-week average of gross demand. Share is of latest data point week ending September 28, 2007.Source: Weekly combo sales week ending September 28, 2007.

NephrologyClinic62%NephrologyRetail41%

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

Jan

’05

Feb

’05

Mar

’05

Apr

’05

May

’05

June

’05

July

’05

Aug

’05

Sep

’05

Oct

’05

Nov

’05

Dec

’05

Jan

’06

Feb

’06

Mar

’06

Apr

’06

May

’06

June

’06

July

’06

Aug

’06

Sep

’06

Oct

’06

Nov

’06

Dec

’06

Jan

’07

Feb

’07

Mar

’07

Apr

’07

May

’07

June

’07

July

’07

Aug

’07

Sep

’07

Post-labelChange


$61

$79 $83

$98

$122

$108$105

0

20

40

60

80

100

120

140

Q1 ’06 Q2 ’06 Q3 ’06 Q4 ’06 Q1 ’07 Q2 ’07 Q3 ’07

Sensipar® Global Growth Drivenby Segment Penetration

$ Millions, Net SalesKey Drivers

Sensipar® third quarter growth of 47% versus the prior yearUS growth of 44% driven by demand International growth of 55% driven by demand, primarily due to continued segment penetration


Sensipar®

19%

40%

50%

67%

0% 20% 40% 60% 80%

Fosrenol®

Oral Zemplar®

Renagel®

Intent to Increase Use in Next 6 Months

Base: Used Product to Treat Secondary HPT Patients.Q1540: For each of the therapies listed, please indicate whether you anticipate your usage of the therapy to increase, decrease, or remain the same over the next six months.Fosrenol® is a registered trademark of Shire Licensing BV Corporation; Zemplar® is a registered trademark of Abbott Laboratories; Renagel® is a registered trademark of GelTex Pharmaceuticals, Inc. Source: Sensipar® ATU Study, August 2007 (proprietary study). n = 197 nephrologists.

67% of Nephrologists Stated That They Intendto Increase Use of Sensipar® in Next 6 Months


Jan 2005 Jan 2006 Jan 2007

In US, Only 14% of ESRD Patients Currently Achieve All Four KDOQI™ Secondary HPT Lab Goals

7%

8%

9%

10%

11%

12%

13%

14%

15%

16%

17%

Jul-0

4

Oct

-04

Jan-

05

Apr

-05

Jul-0

5

Oct

-05

Jan-

06

Apr

-06

Jul-0

6

Oct

-06

Jan-

07

Apr

-07

Jul-0

7

Oct

-07

Jan-

08

% P

atie

nts

14%Nation

11.2%

n = 140,000.OutcomesPlus latest data point represents week ending July 14, 2007.KDOQI™ is a trademark of the National Kidney Foundation, Inc.


Presentation Overview

Overview of our Nephrology Business

Strategies for growth

Amgen Nephrology clinical update

ASN highlights

Helen TorleyVice President and General Manager

Nephrology Business Unit

Robert Brenner, MDExecutive Director

Global Development


Data Highlights at ASN Renal Week 2007

Analyses of Hb patterns, ESA utilization, and impact on patient-reported physical functioning

Results from ACHIEVE, a randomized controlled study demonstrating greater PTH reduction with Sensipar® plus low-dose vitamin D compared to vitamin D alone

Data from DOPPS, Renal REGARDS, and RightStart

Hb = Hemoglobin.


Hemoglobin Variability Remains Stable Despite Changes in Mean Hb

Figure 1. Hb and Population Variability

Hemoglobin = Hb.Mayne, et al. ASN 2007.


Physicians Generally Respond to Hb Excursions With Timely ESA Dose Adjustments

Figure 3. EPO Dose Adjustments Associated With Low and High Hb Excursions

Note: The above dose adjustment analysis is based on repeat 30-day follow-up segments during a Hb excursion. N = total number of individual 30-day follow-up segments examined. Segments where starting dose = 0 are classified as a separate category because percent dose adjustments cannot be calculated. For low Hb excursions, these instances represented dose restarts, while for high Hb excursions these represented continued dose withholding from the previous 30-day follow-up segments.Khan I, et al. ASN 2007.


Lower Hb Levels Are Associated With Higher Mortality, Independent of Baseline Characteristics

Wang, et al. ASN 2007.


Greater EPO Dose Changes Are Associated With Higher Hb Levels in Subsequent Months

Gleeson, et al. ASN 2007.


Elimination of Racial Disparity in Hb Levels in Dialysis Patients Is Associated With EPO Utilization

Trends in EPO Dose by Race, 1999–2004

Uni

ts E

PO

Trends in Hb Levels by Race, 1991–2004

Hb

(g/d

L)

Arenson, et al. ASN 2007.

White Black


Epoetin alfa Improves Patient-Assessed Physical Functioning

Hematocrit

Weakness/Lack of StrengthJansen, et al. ASN 2007.


700

600

500

400

300

200

SCR BL Week 3 Week 7 Week 11 Week 15 Week 19 Week 23 Week 27

ACHIEVE: PTH Reduction Is Greater With Cinacalcet Plus Low-Dose Vitamin D Compared to Vitamin D Alone

Washout

Cinacalcet HCl + Vitamin D: 597 pg/mLVitamin D: 621 pg/mL

Vitamin D: 559

Cinacalcet HCl + Vitamin D: 320.4

Study Week

Med

ian

iPTH

(pg/

mL)

Cinacalcet HCl+ Vitamin D n = 87 87 82 76 76 73 72 72 71

Vitamin D only n = 86 86 83 74 72 66 61 58 58SCR = screening; BL = baseline.Data on file, Amgen.

Cinacalcet HCl + Vitamin D

Vitamin D only


KEEP: Striving to Address Unmet Medical Need for CKD Awareness and Screening

Seminal CKD Screening Program…

Cumulative Number of KEEP Participants by Year

…And Research Opportunity


REGARDS: Kidney Disease Is AssociatedWith a History of Stroke/TIA

Figure 3. Prior Stroke or Transient Ischemic Attack (TIA) (Yes vs No)Adjusted* Prevalence Odds Ratios for Estimated GlomerularFiltration Rate (eGFR)

*Polychotomous logistic regression adjusted for race, gender, geographic region, and components of the Framingham Stroke Risk Score including age, systolic blood pressure, history of diabetes mellitus, smoking status, self-reported cardiovascular disease, atrial fibrillation, and LVH on ECG 3, as well as non-traditional stroke risk factors including BMI, serum albumin, C Reactive Protein, total cholesterol, and anemia.Newsome, et al. ASN 2007.

1.06

1.991.92

Reference

0.7

1.0

1.3

1.6

1.9

2.2

2.5

2.8

≥60 45 to 59 30 to 44 <30

Estimated Glomerular Filtration Rate (eGFR) (ml/min/1.73m2)

Adj

uste

d* O

R (S

trok

e/TI

A, Y

es v

s. N

o)

for e

GFR


RightStart Program: Aggressive and Comprehensive Early Dialysis Care Is Associated With Improved Survival

Wingard RL, et al. CJASN. 2007;2:1170.

Figure 2. Kaplan-Meier Estimates of Cumulative Survival Probability for Both Study Groups


Amgen Is Proud of Our Leadership Role in Conducting Robust Morbidity and Mortality Studies

Study Study Hypothesis Expectedn

Treatment of anemia with Aranesp® reduces the risk of mortality and nonfatal cardiovascular events in patients with CKD and type 2 diabetes

4,000

RED-HF™ TrialTreatment of anemia with darbepoetin alfa in subjects with symptomatic left ventricular systolic dysfunction and anemia decreases the risk of all-cause mortality or hospital admission for worsening HF

3,400

Treatment of secondary HPT with Sensipar® reduces the risk of mortality and nonfatal cardiovascular events in dialysis patients

3,800

A treatment regimen including Sensipar® and low-dose vitamin D will attenuate the progression of coronary artery calcification over a 1-year period, compared with flexible dose vitamin D alone in CKD subjects receiving HD

330


TREAT: Trial to Reduce Cardiovascular Events With Aranesp® (darbepoetin alfa) Therapy

Target Hb 13 g/dL

Control Group

N = 2,000

N = 2,000

Design—randomized (1:1), double-blind, controlled

Mix TC, et al. Am Heart J. 2005;149:408-413.

HypothesisTreatment of anemia with Aranesp® reduces the risk of mortality and

nonfatal cardiovascular events in patients with CKD and type 2 diabetes

Study PopulationHb ≤ 11 g/dLGFR 20–60 mL/minType 2 DM

Primary EndpointAll-cause mortalityNonfatal cardiovascular events (myocardial infarction, myocardial ischemia, HF, stroke)


TREAT Is Fundamentally Different Than CHOIR and CREATE

CREATE CHOIR TREAT

Design Randomized,open-label

Randomized,open-label

Randomized, double-blind, controlled

Sponsor/Agent Roche/NeoRecormon®

(Epoetin beta)J&J/Procrit®

(Epoetin alfa)Amgen/Aranesp®

(darbepoetin alfa)

Population CKD CKD CKD, type 2 diabetes

Arm 1 13–15 13.5 13Hb Target(s),

g/dL Arm 2 10.5–11.5 11.3 Placebo with rescuefor Hb < 9

# Subjects 600 1,432 4,000

Censor at RRT Yes Yes No

NeoRecormon® is a registered trademark of Roche; Procrit® is a registered trademark of Johnson & Johnson.


Amgen Nephrology Portfolio Expanded With Acquisition of Ilypsa

Amgen acquired Ilypsa and their Phase 2 phosphate binder earlier this year

We are initiating an additional Phase 2 study in order to optimize dosing

The Phase 2 results will help inform our Phase 3 program

Amgen: The Leader in NephrologyHelen TorleyVice President and General Manager, Nephrology Business UnitRobert M. Brenner, MD Executive Director, Global Development

November 4, 2007

amgen: the leader in nephrology - iis windows...

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