GEMTESA SIGNIFICANTLY REDUCED
ALL 3 KEY OVERACTIVE BLADDER
SYMPTOMS* AT 12 WEEKS^1-3

At 12 weeks, GEMTESA (vibegron) demonstrated significant reductions in average daily UUI episodes^1,2†

~60% LS mean reduction from baseline in UUI episodes at 12 weeks vs 40% with placebo (2.0 vs 1.4, respectively)¹

12-week Study Design

*The 3 key symptoms of OAB are urgency, micturition frequency, and UUI/leakage.³

^†Statistically significant improvement in UUI in the GEMTESA group vs placebo at Week 12 (P<0.0001).^1,2,4

Urge urinary incontinence (UUI)^1,2

Graph showing reductions in urge urinary incontinence (UUI). Patients taking GEMTESA® had significant reductions in average daily UUI episodes at 12 weeks. — At 12 weeks, GEMTESA (vibegron) demonstrated significant reductions in average daily UUI episodes1,2†
LEAST SQUARE (LS) MEAN CHANGE FROM BASELINE
Week 2 4 8 12
Placebo (n=405) -0.8 -1.0 -1.2 -1.4
GEMTESA 75mg (n=403) -1.4 -1.7 -1.8 -2.0

LEAST SQUARE (LS) MEAN CHANGE FROM BASELINE
Week	2	4	8	12
Placebo (n=405)	-0.8	-1.0	-1.2	-1.4
GEMTESA 75mg (n=403)	-1.4	-1.7	-1.8	-2.0

~60% LS mean reduction from baseline in UUI episodes at 12 weeks vs 40% with placebo (2.0 vs 1.4, respectively)¹

*The 3 key symptoms of OAB are urgency, micturition frequency, and UUI/leakage.³

^†Statistically significant improvement in UUI in the GEMTESA group vs placebo at Week 12 (P<0.0001).^1,2,4

At 12 weeks, GEMTESA demonstrated significant reductions in average daily micturition frequency^1,4*

Please see 12-week study design above.

Micturition frequency^1,2

Graph showing reductions in average daily micturition frequency at 12 weeks. Patients taking GEMTESA® had significant improvements in micturition frequency. — Values
LS MEAN CHANGE FROM BASELINE
Week 2 4 8 12
Placebo (n=520) -0.5 -0.7 -1.0 -1.3
GEMTESA 75mg (n=526) -0.9 -1.2 -1.6 -1.8

LS MEAN CHANGE FROM BASELINE
Week	2	4	8	12
Placebo (n=520)	-0.5	-0.7	-1.0	-1.3
GEMTESA 75mg (n=526)	-0.9	-1.2	-1.6	-1.8

At 12 weeks, GEMTESA demonstrated significant reductions in average daily micturition frequency^1,4*

Patients taking GEMTESA had a ~16% LS mean change from baseline in micturition frequency vs ~11% with placebo (-1.8 vs -1.3, respectively)¹

*Statistically significant improvement in micturition frequency in the GEMTESA group vs placebo at Week 12 (P<0.001).^1,4

Please see 12-week study design above.

At 12 weeks, GEMTESA demonstrated significant reductions in average daily urgency episodes^1,4*

~43% of all OAB patients taking GEMTESA had a 50% reduction in urgency episodes vs placebo (~38%)^2†

*P=0.002 vs placebo.^1,2

^†Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the pivotal EMPOWUR trial.²

Please see 12-week study design above.

Urgency episodes^1,2

Graph showing reductions in average daily urgency episodes. GEMTESA® features urgency reduction data in its label. — Values
LS MEAN CHANGE FROM BASELINE
Week 2 4 8 12
Placebo (n=520) -0.9 -1.1 -1.6 -2.0
GEMTESA 75mg (n=526) -1.5 -1.9 -2.4 -2.7

LS MEAN CHANGE FROM BASELINE
Week	2	4	8	12
Placebo (n=520)	-0.9	-1.1	-1.6	-2.0
GEMTESA 75mg (n=526)	-1.5	-1.9	-2.4	-2.7

~43% of all OAB patients taking GEMTESA had a 50% reduction in urgency episodes vs placebo (~38%)^2†

*P=0.002 vs placebo.^1,2

^†Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the pivotal EMPOWUR trial.²

At 12 weeks, 52.4% of patients taking GEMTESA experienced a ≥75% reduction in daily UUI episodes vs 36.8% of patients on placebo²*

Please see 12-week study design above.

≥75% reduction in daily UUI episodes²

Graph showing achievement of ≥75% reduction in daily urge urinary incontinence (UUI) episodes. 52% of GEMTESA® patients vs ~37% of placebo patients. — Values
% OF PATIENTS ACHIEVING ≥75% REDUCTION IN UUI
12 Weeks
Placebo (n=405) 36.8%
GEMTESA 75mg (n=403) 52.4%

% OF PATIENTS ACHIEVING ≥75% REDUCTION IN UUI
	12 Weeks
Placebo (n=405)	36.8%
GEMTESA 75mg (n=403)	52.4%

*Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the pivotal EMPOWUR trial.²

At 12 weeks, 52.4% of patients taking GEMTESA experienced a ≥75% reduction in daily UUI episodes vs 36.8% of patients on placebo²*

*Data were based on unadjusted values for a supportive outcome measure that was a prespecified secondary endpoint in the pivotal EMPOWUR trial.²

Please see 12-week study design above.

GEMTESA is the first and only beta-3
agonist with urgency reduction data in
its label¹

Urgency is the hallmark OAB symptom^5,6
~60% of individuals with OAB symptoms have urgency episodes without leakage⁷

2-week run-in period²	12-week, double-blind treatment period²
RANDOMIZATION
Placebo	Placebo (n=540)
	GEMTESA 75 mg (n=545)
	Active control (n=430)
Week 0	Week 12

GEMTESA SIGNIFICANTLY REDUCED
ALL 3 KEY OVERACTIVE BLADDER
SYMPTOMS* AT 12 WEEKS^1-3

Urge urinary incontinence (UUI)^1,2

At 12 weeks, GEMTESA demonstrated significant reductions in average daily micturition frequency^1,4*

Micturition frequency^1,2

Urgency episodes^1,2

≥75% reduction in daily UUI episodes²

GEMTESA is the first and only beta-3
agonist with urgency reduction data in
its label¹

12-week, double-blind treatment period

Studied in more than 1500 patients with overactive bladder^1,2

GEMTESA met efficacy endpoints¹

12-week patient demographics^1,2

Treatment naïve or had prior ACh or beta-3 agonist use in 12 months before study

Symptoms of OAB ≥3 months with average ≥8 micturitions/day and ≥1 UUI/day, or average ≥8 micturitions/day and average ≥3 urgency episodes/day^1‡

GEMTESA SIGNIFICANTLY REDUCED ALL 3 KEY OVERACTIVE BLADDER SYMPTOMS* AT 12 WEEKS1-3

Urge urinary incontinence (UUI)1,2

At 12 weeks, GEMTESA (vibegron) demonstrated significant reductions in average daily UUI episodes1,2†

At 12 weeks, GEMTESA demonstrated significant reductions in average daily micturition frequency1,4*

Micturition frequency1,2

Values

Urgency episodes1,2

Values

≥75% reduction in daily UUI episodes2

Values

GEMTESA is the first and only beta-3agonist with urgency reduction data inits label1

12-week, double-blind treatment period

Studied in more than 1500 patients with overactive bladder1,2

Values

GEMTESA met efficacy endpoints1

12-week patient demographics1,2

Treatment naïve or had prior ACh or beta-3 agonist use in 12 months before study

Symptoms of OAB ≥3 months with average ≥8 micturitions/day and ≥1 UUI/day, or average ≥8 micturitions/day and average ≥3 urgency episodes/day1‡

GEMTESA SIGNIFICANTLY REDUCED
ALL 3 KEY OVERACTIVE BLADDER
SYMPTOMS* AT 12 WEEKS^1-3

Urge urinary incontinence (UUI)^1,2

At 12 weeks, GEMTESA demonstrated significant reductions in average daily micturition frequency^1,4*

Micturition frequency^1,2

Urgency episodes^1,2

≥75% reduction in daily UUI episodes²

GEMTESA is the first and only beta-3
agonist with urgency reduction data in
its label¹

Studied in more than 1500 patients with overactive bladder^1,2

GEMTESA met efficacy endpoints¹

12-week patient demographics^1,2

Symptoms of OAB ≥3 months with average ≥8 micturitions/day and ≥1 UUI/day, or average ≥8 micturitions/day and average ≥3 urgency episodes/day^1‡