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NASDAQ: AVNC - IIS …library.corporate-ir.net/.../AVNC091505FINALslides.pdf2 Advancis Investor Webcast Presentation Speakers: Presented September 15, 2005 Edward Rudnic, Ph.D. Steven

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www.advancispharm.com NASDAQ: AVNC

2

Advancis Investor Webcast PresentationAdvancis Investor Webcast Presentation

Speakers:Speakers:

Presented September 15, 2005Presented September 15, 2005

Edward Rudnic, Ph.D.

Steven Shallcross

Bob Bannon

Edward Rudnic, Ph.D.

Steven Shallcross

Bob Bannon

Chairman and CEO

SVP and CFO

Sr. Director, IR

Chairman and CEO

SVP and CFO

Sr. Director, IR

3

Advancis Safe Harbor StatementAdvancis Safe Harbor Statement

This presentation contains forward-looking statements. These statements relate to future events or to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond our control and which could materially affect actual results, levels of activity, performance or achievements. Risk factors that could cause actual results to differ from such forward-looking statements are contained in our filings with the Securities and Exchange Commission. We are under no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

4

Amoxicillin PULSYS Once-a-DayAmoxicillin PULSYS Once-a-DayAmoxicillin is the most widely prescribed antibioticAmoxicillin is a safe drug – PULSYS is even betterPULSYS will be the first Once-a-Day amoxicillinPULSYS allows one-third to one-half the total dosePULSYS technology has the potential for fewer days of therapy

Amoxicillin is the most widely prescribed antibioticAmoxicillin is a safe drug – PULSYS is even betterPULSYS will be the first Once-a-Day amoxicillinPULSYS allows one-third to one-half the total dosePULSYS technology has the potential for fewer days of therapy

Pl a

sma

Con

c ent

r atio

nP

l asm

a C

onc e

ntr a

tion

24-hr dosing of Antibiotic24-hr dosing of Antibiotic120 24

5

Prior Pivotal StudiesPrior Pivotal Studies

Non-inferiority amoxicillin PULSYS to Pen VK775mg APC-111 MP Tablet QD 7 days to250 mg Pen VK QID for 10 days475/775mg APC-231 MP Sprinkle QD 7 days to 10 mg/kg Pen VK QID for 10 days

At least 85% bacteriological eradication

Non-inferiority amoxicillin PULSYS to Pen VK775mg APC-111 MP Tablet QD 7 days to250 mg Pen VK QID for 10 days475/775mg APC-231 MP Sprinkle QD 7 days to 10 mg/kg Pen VK QID for 10 days

At least 85% bacteriological eradication

6

Reasons for Clinical Failure:Reasons for Clinical Failure:

Amoxicillin is actively absorbedPoor absorption is more acute in extended-releaseHistorical data are based on immediate-releaseOnly a 15% failure rate can be toleratedFuture approaches must focus on low-absorbers

77% of patients had complete eradicationHalf the daily doseSeven vs. Ten days duration

Close, but consistent miss

Amoxicillin is actively absorbedPoor absorption is more acute in extended-releaseHistorical data are based on immediate-releaseOnly a 15% failure rate can be toleratedFuture approaches must focus on low-absorbers

77% of patients had complete eradicationHalf the daily doseSeven vs. Ten days duration

Close, but consistent miss

7

Other Clinical IssuesOther Clinical Issues

Previous estimates of 40% T>MIC:Included all Strep. – Strep. Pneumo different from Group A Strep.Needs to be 50-60% T>MIC for Group A Strep

Many clinicians require 10 day therapy:Guarantees high eradication ratesNeed 10 days to eradicate rheumatic fever producing strains

Group A Strep resistance to penicillins not evidentIncreasing for all other classes of antibioticsPenicillin mode of action not completely understood

Previous estimates of 40% T>MIC:Included all Strep. – Strep. Pneumo different from Group A Strep.Needs to be 50-60% T>MIC for Group A Strep

Many clinicians require 10 day therapy:Guarantees high eradication ratesNeed 10 days to eradicate rheumatic fever producing strains

Group A Strep resistance to penicillins not evidentIncreasing for all other classes of antibioticsPenicillin mode of action not completely understood

8

Amoxicillin PULSYS vs Pen VK ADULT Daily %T>MICAmoxicillin PULSYS vs Pen VK ADULT Daily %T>MIC

Pen

VK

250

QID

Fast

ing

Low-

Cal M

eal

High

-Fat

Mea

l

All F

ed D

ata

%T>

MIC

/Day

(0.0

15 µ

g/m

L)

0

20

40

60

80

100

10-Day Treatments7-Day Treatments

9

ADULT Total T>MIC 10 Day vs. 7 Day TreatmentADULT Total T>MIC 10 Day vs. 7 Day Treatment

0

2

4

6

8

10

12Pe

n VK

250

QID

10d

APC

-111

7d

APC

-111

10d

Tota

l T>M

IC -

Day

s

Pen VK 250 QID 10d APC-111 7d APC-111 10d

10

Support from LiteraturePen VK - PK/PD in AdultsSupport from LiteraturePen VK - PK/PD in Adults

%Eradication vs Total T>MIC

0

20

40

60

80

100

120

0 1 2 3 4 5 6 7

Total T>MIC (Days)

% E

radi

catio

n

Pen VK 500 TID Pen VK 250 QID Pen VK 600 TIDPen VK 250 TID Pen VK 800 BID Pen VK 750 QD

11

T>MIC Cutoff AssessmentProjected Ph-3 Failures Based on Different %T>MIC Cutoffs (Using Phase 1 Data)T>MIC Cutoff AssessmentProjected Ph-3 Failures Based on Different %T>MIC Cutoffs (Using Phase 1 Data)

Projected Phase 3 Failures - Unbound Drug at MIC 0.015

0

20

40

60

80

100

120

140

160

30% 40% 50% 60% 70% 80%

%T>MIC Efficacy Cutoff

# Fa

ilure

s Pr

ojec

ted

in P

hase

3

(N=1

71)

Failures Projected from Ph-1 Data Observed Failures

12

Regression of Human Pharyngitis Trials vs. PULSYS 10 DayRegression of Human Pharyngitis Trials vs. PULSYS 10 Day

Adults - %Eradication vs Total T>MIC - FED Treatment Only

0

20

40

60

80

100

120

0 2 4 6 8 10

Total T>MIC (Days)

% E

radi

catio

n

APC-111 QD x 10 DAYS -1 SD Low Mean+1SD High -2SD +2SD

Taken with Food

13

Adults - %Eradication vs Total T>MIC (± 1 SD)

-20

0

20

40

60

80

100

120

0 2 4 6 8 10

Total T>MIC (Days)

% E

radi

catio

n

Model Fit -1 SD +1 SD

Adults - %Eradication vs Total T>MIC (± 1 SD)

-20

0

20

40

60

80

100

120

0 2 4 6 8 10

Total T>MIC (Days)

% E

radi

catio

n

Model Fit -1 SD +1 SD

Bacterial Eradication Model –Probability of 10-Day Treatment (fed and fasted)Bacterial Eradication Model –Probability of 10-Day Treatment (fed and fasted)

78.5%

103.4%90.8%

Amox PULSYS775mg x 10 days

14

Adults - %Eradication vs Total T>MIC (± 1 SD)

-20

0

20

40

60

80

100

120

0 2 4 6 8 10

Total T>MIC (Days)

% E

radi

catio

n

Model Fit -1 SD +1 SD

Adults - %Eradication vs Total T>MIC (± 1 SD)

-20

0

20

40

60

80

100

120

0 2 4 6 8 10

Total T>MIC (Days)

% E

radi

catio

n

Model Fit -1 SD +1 SD

79.6%

103.9%91.6%

Bacterial Eradication Model –Probability of 10-Day Treatment (fed)Bacterial Eradication Model –Probability of 10-Day Treatment (fed)

Amox PULSYS775mg x 10 days

15

Amox PULSYS 775mg Once-a-Day x 10 Days (Fed)Amox PULSYS 775mg Once-a-Day x 10 Days (Fed)

0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

0 1 2 3 4 5 6 7 8 9 10 11

Treatment Duration (days)

Dai

ly %

T>M

IC 111.301Proposed 111.302

-1 SD

-2 SD

+1 SD

+2 SD

16

New Pivotal Trial Design: Maximize Success - OverviewNew Pivotal Trial Design: Maximize Success - Overview

Consistent with 111.301Same formulationElements of study designImplementation

New trial design elements- 111.302APC-111 MP tablet QD for 10 days after a mealCompliance

First dose in clinicOn therapy visit day 3 – 5Phone Calls and Dosing diary

Focus on High Performance Sites

Consistent with 111.301Same formulationElements of study designImplementation

New trial design elements- 111.302APC-111 MP tablet QD for 10 days after a mealCompliance

First dose in clinicOn therapy visit day 3 – 5Phone Calls and Dosing diary

Focus on High Performance Sites

17

Antibiotic Usage Remains ConstantAntibiotic Usage Remains Constant

Amoxicillin is the predominant penicillinCephalexin is the predominant cephalosporinAmoxicillin is the predominant penicillinCephalexin is the predominant cephalosporin

Source: IMS HealthSource: IMS Health

0

50

100

150

200

250

US

Rx'

s (M

il)

2000 2001 2002 2003 2004

Total Penicillins Cephalosporins

18

Top Four Prescribed Oral Antibiotics in 2004

Once-A-Day PULSYS Changes the Competitive Landscape

Top Four Prescribed Oral Antibiotics in 2004

Once-A-Day PULSYS Changes the Competitive Landscape

Amoxicillin55MM RxAmoxicillin55MM Rx

Zithromax40MM RxZithromax40MM Rx

Keflex/Cephalexin24MM RxKeflex/Cephalexin24MM Rx

Amox/Clavulanate23MM RxAmox/Clavulanate23MM Rx

OthersOthers

2-3 times per day10-14 days

Once per day1-5 days2-4 times per day

10-14 days

2-3 times per day10-14 days

19

Amoxicillin PULSYS Market ResearchOnce-Daily, 10-Day Course of Amoxicillin PULSYSAmoxicillin PULSYS Market ResearchOnce-Daily, 10-Day Course of Amoxicillin PULSYS

Sample of 100 PCPs and 100 PediatriciansThe typical survey respondent had been in practice for approximately 15 to 16 yearsPhysicians were high volume prescribers of amoxicillin (deciles 9-10)

Sample of 100 PCPs and 100 PediatriciansThe typical survey respondent had been in practice for approximately 15 to 16 yearsPhysicians were high volume prescribers of amoxicillin (deciles 9-10)

20

50% of Physicians are “Very Likely to Prescribe”Amoxicillin PULSYS QD to Patients 12+ Years50% of Physicians are “Very Likely to Prescribe”Amoxicillin PULSYS QD to Patients 12+ Years

Q4. If this product were available and based on what you have read about it, please rate how likely you would be to prescribe it for the treatment of pharyngitis/tonsillitis; using a 1 to 7 scale where 1 = Definitely would not prescribe and 7 = Definitely would prescribe.

P r e s c r ib in g L ik e l ih o o d o f A m o x ic il l in Q D

5 2

5 0

5 1

4 4

4 6

4 5

4

4

4

0 % 1 0 0 %

P E D s

P C P s

T o t a l

V e r y L ik e ly ( 6 ,7 ) N e u t r a l ( 3 - 5 ) N o t a t a l l L ik e ly ( 1 , 2 )

Mean Rating

5.4

5.4

5.3

21

Amoxicillin PULSYS May Capture Greater than 50% of Amoxicillin Use for Treatment of PharyngitisAmoxicillin PULSYS May Capture Greater than 50% of Amoxicillin Use for Treatment of Pharyngitis

4 3

1 0 0

4 6

1 0 0

4 5

1 0 0

5 7

5 4

5 5

0 % 2 5 % 5 0 % 7 5 % 1 0 0 %

A n t ic ip a t e d S h a r e -Q D ( Q 1 0 )

C u r r e n t S h a r e P E D s( Q 2 )

A n t ic ip a t e d S h a r e -Q D ( Q 1 0 )

C u r r e n t S h a r e P C P s( Q 2 )

A n t ic ip a t e d S h a r e -Q D ( Q 1 0 )

C u r r e n t S h a r e T o t a l( Q 2 )

A m o x i c i l l i n P r o d u c t A m o x i c i l l i n P U L S Y S

4 3

1 0 0

4 6

1 0 0

4 5

1 0 0

5 7

5 4

5 5

0 % 2 5 % 5 0 % 7 5 % 1 0 0 %

A n t ic ip a t e d S h a r e -Q D ( Q 1 0 )

C u r r e n t S h a r e P E D s( Q 2 )

A n t ic ip a t e d S h a r e -Q D ( Q 1 0 )

C u r r e n t S h a r e P C P s( Q 2 )

A n t ic ip a t e d S h a r e -Q D ( Q 1 0 )

C u r r e n t S h a r e T o t a l( Q 2 )

A m o x i c i l l i n P r o d u c t A m o x i c i l l i n P U L S Y S

22

Average Maximum Price of Amoxicillin PULSYS QD is $36.55 per course. Average Maximum Price of Amoxicillin PULSYS QD is $36.55 per course.

Q9b. What is the maximum price per course of treatment at which you would still be willing to prescribe Amoxicillin PULSYS?

% o f P h y s ic ia n s S t i l l W i l l in g t o R x A m o x ic i l l in Q D a t E a c h P r ic e P o in t

1 0 0

8 4

6 86 0

4 2 3 9

2 4

1 0

8 8

1 64

1 0 0

8 1

3 1

1 5

5 05 0

6 37 1

1 0 0

6 45 6

3 42 8

0

2 0

4 0

6 0

8 0

1 0 0

$ 1 5 - $ 1 9 $ 2 0 - $ 2 4 $ 2 5 - $ 2 9 $ 3 0 - $ 3 4 $ 3 5 - $ 3 9 $ 4 0 - $ 4 9 $ 5 0 - $ 5 9 $ 6 0 +

Perc

enta

ge o

f R

espo

nden

ts

T o t a l P C P s P E D s

Mean $: $37 $43 $30

Median $: $30 $35 $30

23

Average Rx Per Physician by Decile, AmoxicillinAverage Rx Per Physician by Decile, Amoxicillin

673

118167

223293

385

515

723

1,179

0

200

400

600

800

1000

1200

1400

Decile

1 Dec

ile 2

Decile

3Dec

ile 4

Decile

5Dec

ile 6

Dec

ile 7

Decile

8Dec

ile 9

Decile

10

Annual Rx's

673

118167

223293

385

515

723

1,179

0

200

400

600

800

1000

1200

1400

Decile

1 Dec

ile 2

Decile

3Dec

ile 4

Decile

5Dec

ile 6

Dec

ile 7

Decile

8Dec

ile 9

Decile

10

Annual Rx's

Source: IMS Prescriber Specialty

24

Sales Force Targets 13,000 MDsSales Force Targets 13,000 MDs

23,125

17,497

13,248

9,144

4,559

0

5,000

10,000

15,000

20,000

25,000

Decile 6 Decile 7 Decile 8 Decile 9 Decile 10

Phys

icia

ns

23,125

17,497

13,248

9,144

4,559

0

5,000

10,000

15,000

20,000

25,000

Decile 6 Decile 7 Decile 8 Decile 9 Decile 10

Phys

icia

ns

Sales Force

Source: IMS Prescriber Specialty

25

Commercial Plan Targets 67,000 PhysiciansCommercial Plan Targets 67,000 Physicians

58,018

40,269

30,544

23,125

17,49713,248

9,1444,559

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

Decile

1 Dec

ile 2

Decile

3Dec

ile 4

Decile

5Dec

ile 6

Dec

ile 7

Decile

8Dec

ile 9

Decile

10

Physicians

58,018

40,269

30,544

23,125

17,49713,248

9,1444,559

0

10,000

20,000

30,000

40,000

50,000

60,000

70,000

Decile

1 Dec

ile 2

Decile

3Dec

ile 4

Decile

5Dec

ile 6

Dec

ile 7

Decile

8Dec

ile 9

Decile

10

Physicians

Marketing Plan

Source: IMS Prescriber Specialty

26

Aminopenicillin Prescriptions by Payer Aminopenicillin Prescriptions by Payer

3rd Party Payer74%

Cash14%

Medicaid12%

3rd Party Payer74%

Cash14%

Medicaid12%

Source: Verispan

27

Managed Care is Receptive to Amoxicillin PULSYSManaged Care is Receptive to Amoxicillin PULSYS

Co-Pays are Increasing2nd Tier/Brand Co-Pay is 2X GenericExpands $600 Million Market 2-3X

Co-Pays are Increasing2nd Tier/Brand Co-Pay is 2X GenericExpands $600 Million Market 2-3X

05

1015

20253035

05

1015

20253035

2004 Average Co-Pay 2004 Average Co-Pay

GenericGeneric 2nd Tier Brand2nd Tier Brand 3rd Tier Brand3rd Tier Brand

$$

28

$300+MMEntire Market Opportunityfor Pharyngitis/Tonsillitis

$300+MMEntire Market Opportunityfor Pharyngitis/Tonsillitis

Amoxicillin PULSYS U.S. Market Exceeds $1 BillionAmoxicillin PULSYS U.S. Market Exceeds $1 Billion

Market PrescriptionsMarket Prescriptions 55MM Total Rx55MM Total Rx

Pharyngitis UsagePharyngitis Usage

PULSYS Rx ValuePULSYS Rx Value

26% of Total Rx26% of Total Rx

$20 -$24 Brand Rx$20 -$24 Brand Rx

Bronchitis – 6%Sinusitis – 12%

Otitis Media – 31%Others – 25%

Bronchitis Bronchitis –– 6%6%Sinusitis Sinusitis –– 12%12%

Otitis Media Otitis Media –– 31%31%Others Others –– 25%25%

29

PULSYS Creates ValuePULSYS Creates Value

Generic AntibioticsLow price – Low marginNo promotion or detailing

Discovery efforts focused on serious hospital infections

Premium Brand AntibioticsHigh price – High marginPremium brand marketing effort

Generic AntibioticsLow price – Low marginNo promotion or detailing

Discovery efforts focused on serious hospital infections

Premium Brand AntibioticsHigh price – High marginPremium brand marketing effort

Advancis’ AntibioticsModerate price – High margin ( 90+%)Premium brand marketing effortStrong detail story to high-volume prescribers

Advancis’ AntibioticsModerate price – High margin ( 90+%)Premium brand marketing effortStrong detail story to high-volume prescribers

30

PULSYS Franchise for Community InfectionsLaunch Within Near-Term Horizon (2006-09)PULSYS Franchise for Community InfectionsLaunch Within Near-Term Horizon (2006-09)

Multiple products: First-line oral antibioticsMultiple, highly-prescribed indicationsMultiple physician specialties targeted with community-based sales force

Multiple products: First-line oral antibioticsMultiple, highly-prescribed indicationsMultiple physician specialties targeted with community-based sales force

Upper Respiratory Upper Respiratory Tract InfectionsTract Infections

Lower RespiratoryLower RespiratoryTract InfectionsTract Infections

Skin & Skin StructureSkin & Skin StructureInfectionsInfections

Pharyngitis/TonsillitisPharyngitis/TonsillitisAcute BronchitisAcute BronchitisSinusitisSinusitisAcute Otitis MediaAcute Otitis Media

Community AcquiredCommunity AcquiredPneumoniaPneumoniaAcute Exacerbation of Acute Exacerbation of Chronic BronchitisChronic Bronchitis

Wounds/lacerationsWounds/lacerationsCellulitisCellulitisPostPost--Op SurgicalOp SurgicalOthersOthers

AmoxicillinAmoxicillinAmoxicillin/ClavulanateAmoxicillin/ClavulanateCombinationsCombinations

Amoxicillin/MacrolideAmoxicillin/MacrolideAnd/or And/or CephCeph/Macrolide /Macrolide Combination(sCombination(s))

Keflex (cephalexin)Keflex (cephalexin)CefuroximeCefuroxime axetilaxetilOther CephalosporinOther Cephalosporin

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