Pharmasset Inc - FORM 8-K - EX-99.2 - CONFERENCE CALL SLIDES

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EX-99.1 - PRESS RELEASE - Pharmasset Inc	d251734dex991.htm

www.pharmasset.com

NASDAQ: VRUS

Exhibit 99.2

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Forward-Looking Statements

Pharmasset “Safe Harbor”

Statement under the Private Securities Litigation

Reform Act of 1995: Statements in this presentation that are not historical

facts are “forward-looking statements,”

including, without limitation,

statements that involve risks, uncertainties, and other important factors,

including, without limitation, the risk of cessation or delay of any of the

ongoing or planned clinical trials and/or our development of our

product

candidates, the risk that the results of previously conducted studies

involving our product candidates will not be repeated or observed in ongoing

or future studies involving our product candidates, the risk that our

collaboration with Roche will not continue or will not be successful, and the

risk that any one or more of our product candidates will not be successfully

developed and commercialized. For a discussion of risks, uncertainties, and

other important factors, any of which could cause our actual results to differ

from those contained in the forward-looking statements, see the section

entitled "Risk Factors" in our Annual Report on Form 10-K for the fiscal year

ended September 30, 2010 and Form 10-Q for fiscal quarter ended June 30,

2011 filed with the Securities and Exchange Commission and discussions of

potential risks, uncertainties, and other important factors in our subsequent

filings with the Securities and Exchange Commission.

Nucleoside/tide Analog Pipeline

Focused on HCV

Product

& Territories

Pre-clinical

Phase 1

Phase 2

RG7128

US HIV co-promotion,

Latin America, Korea

PSI-7977

Worldwide

Phase 3

PSI-938

Worldwide

PSI-352938

Preclinical/

Research

NDA

2H13

2014

PSI-7977 Phase 2 Data Support

IFN-free, Pan-GT Registrational Program

High SVR across studies, across HCV GTs, No Resistance

PROTON –

91% SVR HCV GT1 (43/47)

–

No non-responders; no virologic failure or resistance; 1

relapse

–

No discontinuations related to PSI-7977

–

Results independent of predictors of interferon response

PROTON –

96% SVR HCV GT2/GT3 (24/25)

–

No non-responders; no virologic failure or resistance; no

relapse

–

Results independent of predictors of interferon response

ATOMIC

–

“12+0”

HCV GT1 (n=50)

–

Rapid enrollment; establish safety database for Phase 3 start

ELECTRON –

Proof of Concept for IFN-free

–

Data

presented

AASLD

Nov

PSI-7977 Safety Database Supports

IFN-free, Pan-GT Registrational Program

No identified safety signal for PSI-7977 to date

>300 patients PSI-7977 400 mg QD x 12 wks

No discontinuations due to PSI-7977

No Maximum Tolerated Dose

–

Single doses up to 1200 mg

All Required Clinical Pharmacology Complete

–

Support enrollment of relevant HCV pt populations

•

Methadone & QT data at AASLD

Phase 3 FISSION:

PSI-7977/RBV in Treatment-Naïve Patients with

HCV GT2 or GT3

N=~250

PSI-7977 400mg + RBV

Peg-IFN + RBV

SVR12

~500 treatment naïve patients with HCV GT2 or GT3

HCV GT3 enrolled 3:1 over HCV GT2

International enrollment

SVR

endpoint,

superiority

design

assumes

15%

Initiating trial –

first patient, first dose by end of 2011

FISSION

Phase 3 POSITRON:

PSI-7977/RBV in Patients with HCV GT2 or GT3

Who Cannot Take Interferon

N=~150

N=~75

PSI-7977 400mg QD + RBV

PSI-7977 placebo + RBV placebo

SVR12

~225 Patients with HCV GT2 or GT3

–

Cannot take interferon

–

International trial

Primary endpoint SVR12, superiority design

Initiate in early 2012

POSITRON

Phase 3 NEUTRINO:

PSI-7977/RBV in Patients with HCV

Who Cannot Take Interferon

N=~210

N=~70

PSI-7977 400mg QD + RBV

PSI-7977 placebo + RBV placebo

SVR12

Final study design will be based on emerging data:

–

QUANTUM:

Planned

Interim

analysis

first

225

patients

–

ELECTRON:

•

PSI-7977/RBV in prior null and treatment-naïve patients with

HCV GT1

•

Additional arms in prior non-responders with GT2/GT3

Primary endpoint SVR12, superiority design

Initiate trial in mid-2012

NEUTRINO

Phase 3 Expense

with shareholder support

Overall Phase 3 Costs Manageable

–

3 core studies: 1,005 patients @ $100K/pt = $101Million

Strong Balance Sheet

–

$188M as of 6/30/2011

–

Cash use in 3Q11: $22.6M

Key Catalysts Ahead

–

PSI-7977 + RBV in GT1 pts (ELECTRON) : 1H2012

–

QUANTUM

interim data (all GTs) : 2Q2012

–

ATOMIC

interim data (non GT2/3): 2Q2012

No Near Term Financing Planned

First IFN-Free Regimen in Phase 3

Phase 3 IFN-free program with PSI-7977/RBV

–

All 12 week regimens

–

FISSION

trial in HCV GT2/3 treatment naïve patients

–

POSITRON

trial in HCV GT2/3 patients who cannot take IFN

–

NEUTRINO

trial in HCV patients who cannot take IFN

Anticipate NDA filing in Second half of 2013

–

Submit all 3 Phase 3 studies

–

Safety database of >1,250 patients

–

Broad label covering multiple genotypes

We believe the future of HCV treatment is a short duration

of interferon free therapy

www.pharmasset.com

NASDAQ: VRUS

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