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Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval. Significant Decrease in Urinary Incontinence in Both Pivotal Studies Study 515 Wee k 2 Wee k 6 Wee k 12 -25 -20 -15 -10 -5 0 Placeb o N=149 Mean change from baseline (episodes/week) Study 516 Wee k 2 Wee k 6 Wee k 12 -25 -20 -15 -10 -5 0 Placebo N=92 Mean change from baseline (episodes/week) * * * * * * p= <0.05; ** p= <0.001 in pairwise comparison versus placebo Mean baselines: Placebo = 28.3/wk, 200U = 32.3/wk * * * * Mean baselines: Placebo = 36.7/wk, 200U = 32.5/wk 1. From NDO Clinical Program Overview - BOTOX ® (onabotulinumtoxinA), NDO Clinical Trial

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Page 1: Botoxcharts

Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.

Significant Decrease in Urinary Incontinence in Both Pivotal Studies

Study 515Week 2

Week 6

Week 12

-25

-20

-15

-10

-5

0

PlaceboN=149200UN=135

Mea

n ch

ange

from

bas

elin

e (e

piso

des/

wee

k)

Study 516Week 2

Week 6

Week 12

-25

-20

-15

-10

-5

0PlaceboN=92200UN=92

Mea

n ch

ange

from

bas

elin

e (e

piso

des/

wee

k)

*

** **

* p= <0.05; ** p= <0.001 in pairwise comparison versus placebo

Mean baselines:Placebo = 28.3/wk, 200U = 32.3/wk

**

**

Mean baselines:Placebo = 36.7/wk, 200U = 32.5/wk

1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial

Page 2: Botoxcharts

Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.

High Proportion of Treatment Responders

% of patients with ≥50% decrease in urinary

incontinence

Placebo 200U0

10

20

30

40

50

60

70

80

90

100

Week 6

% o

f P

ati

en

ts% of patients with 100%

decrease in urinary incontinence (‘DRY’)

Placebo 200U0

10

20

30

40

50

60

70

80

90

100

% o

f P

ati

en

ts

**

** p= <0.001 in among-group comparison,

**

Week 6

1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial

Page 3: Botoxcharts

Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.

Significant Increase in MCC in Both Pivotal Studies

Study 515

Series10

20

40

60

80

100

120

140

160

180

PlaceboN=129

200UN=123

Mea

n ch

ange

from

bas

elin

e (m

L)

Study 516

Series10

20

40

60

80

100

120

140

160

180

PlaceboN=85

200UN=88

** **

** p= <0.001 in pairwise comparison versus placebo

1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial

Page 4: Botoxcharts

Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.

Series1

-40

-35

-30

-25

-20

-15

-10

-5

0

5

10

PlaceboN=68

200UN=29

Mea

n ch

ange

from

bas

elin

e (c

mH2

O)

Significant Reduction in MDP During First IDC in Both Pivotal Studies

Study 515

Series1

-40

-35

-30

-25

-20

-15

-10

-5

0

5

10

PlaceboN=103

200UN=41

Mea

n ch

ange

from

bas

elin

e (c

mH

2O)

Study 516

**

**

** p= <0.001 in pairwise comparison versus placebo

1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial

Page 5: Botoxcharts

Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.

Week 6

Week 12

0

5

10

15

20

25

30

35

PlaceboN=149

200UN=135

Mea

n ch

ange

from

bas

elin

e (t

otal

sco

re)

Week 6

Week 12

0

5

10

15

20

25

30

PlaceboN=92

200UN=92

Mea

n ch

ange

from

bas

elin

e (t

otal

sco

re)

Significant Improvement in Quality of Life in Both Pivotal Studies

** p= <0.001 in pairwise comparison versus placebo

Study 515 Study 516

Baseline Baseline

1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial

Page 6: Botoxcharts

Plans are forward looking and are in preparation for FDA approval. No promotional activity will occur prior to FDA approval.

Placebo

200U

0 10 20 30 40 50

Weeks

Long Duration of Effect:Patient Request for Re-Treatment

Patient could not request re-treatment until week 12

Median = 38.4 weeks

Median = 13.1 weeks

1. From NDO Clinical Program Overview - BOTOX® (onabotulinumtoxinA), NDO Clinical Trial