Slide 1: Gilead to Acquire Pharmasset
Gilead to Acquire Pharmasset November 21, 2011 Exhibit 99.2
Slide 2: Safe Harbor Disclaimer
Safe Harbor Disclaimer Statements included in this presentation that are not historical in nature are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Gilead cautions readers that forward-looking statements are subject to certain risks and unce
Slide 3: Agenda
Agenda 1. Pharmasset Acquisition Highlights 2. HCV Landscape 3. Overview of Pharmasset HCV Portfolio 4. Gilead’s Combined HCV Opportunity Page
Slide 4: Pharmasset Acquisition Highlights
Pharmasset Acquisition Highlights
Slide 5: Terms of the Agreement
Terms of the Agreement Cash tender offer at $137 per share Transaction value of approximately $11 billion Tender offer expected to close within Q1 12 – Subject to minimum tender requirement – Hart-Scott-Rodino (antitrust) clearance – Other customary conditions
Slide 6: Strategic Rationale
Strategic Rationale Accelerates Gilead’s strategy to develop the first all-oral regimen for the treatment of HCV – PSI-7977 is the most potent, advanced nucleotide in clinical development – Phase 3 clinical studies of PSI-7977 in combination with ribavirin open to enrollment – Targeted U.S. FDA appr
Slide 7: Fit with Gilead’s Areas of Operational Excellence
Fit with Gilead’s Areas of Operational Excellence Established expertise and commitment to liver disease Preclinical, clinical development and regulatory expertise – Developed and commercialized 5 HIV and 2 hepatitis products – Viread regulatory approvals in approximately 140 countries – Established
Slide 8: @ GILEAD
@ GILEAD @ GILEAD
Slide 9: Global Prevalence of HCV is Estimated to be 160 Million Individuals
<1% 1-1.9% 2-2.9% >3% Not tested HCV Prevalence in Core and Emerging Markets (M) Global Prevalence of HCV is Estimated to be 160 Million Individuals (1) HCV Prevalence (% of population) Region US Japan Europe Other Asia Latin America All GT 2.9 3.7 0.6 6.7 70.8 5.4 GT1 (%) 73% 63% 70% 65% 39% 68% EU
Slide 10: HCV: A Significant Unmet Medical Need
Over Million Infected Individuals in Major Markets (1) with Fewer than 200,000 Treated per Year Treated/ Year Diagnosed Prevalence 12,601 Patients in thousands 36% 4,524 1. Major markets include US, EU-5, Japan, Australia, Austria, Brazil, Denmark, Finland, Greece, Ireland, Norway, Poland, Portugal,
Slide 11: HCV Treatment Evolution
IFN 24 Wk IFN 48 Wk IFN/RBV 24 Wk IFN/RBV 48 Wk (1998) IFN/RBV 48 Wk (2001) PegIFN/RBV 48 Wk PI + PegIFN/RBV 48 Wk (2011) 6% 13-19% 31-35% 38-43% 45-47% 54-63% 66-79% IFN 24 Weeks IFN 48 Weeks IFN/RBV 24 Weeks IFN/RBV 48 Weeks 1998 IFN/RBV 48 Weeks 2001 PegIFN/RBV 48 Weeks Protease Inhibitor + PegIF
Slide 12: Challenges of Current PI-based Treatment Remains
Challenges of Current PI-based Treatment Remains Additional safety issues and exacerbation of side effects (rash and anemia) – Discontinuation rates significantly increased on PIs Lower response rates in sub-populations (previous IFN/RBV non-responders, cirrhotics) Burdensome for patients and practi
Slide 13: Ultimate Goal in HCV Therapy
Ultimate Goal in HCV Therapy Once a day Pan-genotype No clinical resistance No response guided therapy Short duration Safe with manageable side effects High cure rates Suitable for all populations Ideal HCV Therapy Most Likely Achieved Ideal HCV Therapy Most Likely Achieved through a Combination of
Slide 14: IFN Free Strategy
2010 2011 2020 2010 2011 2020 IFN Free Strategy Ultimate Goal The Evolution of HCV Therapy: 2010 Current Standard of Care (SOC): PEG + RBV Combination Oral Antivirals + Shorter Course IFN Broad Genotypic Oral Antiviral Regimen The First Antivirals + SOC to Improve Response Rates and Reduce Duration
Slide 15: The Competitive Nature and Speed of Development
2010 2011 2020 2014 Current Standard of Care (SOC): PEG + RBV The First Antivirals + SOC to Improve Response Rates and Reduce Duration The Competitive Nature and Speed of Development Have Significantly Accelerated the Timelines Ultimate Goal All Oral Antiviral Regimen IFN Free Strategy 2010 2011 202
Slide 16: Overview of Pharmasset HCV Portfolio
Overview of Pharmasset HCV Portfolio
Slide 17: Pharmasset’s HCV Nucleotide Portfolio
PSI-7977 PSI-938 RG 7128 Pharmasset’s HCV Nucleotide Portfolio • 3.6 log HCV RNA with 400 mg QD over 3 days • Phase 3 in combination with ribavirin open to enrollment • Highest on treatment and SVR rates to date • Unpartnered with worldwide rights • 3.6 log HCV RNA with 300 mg QD over 3 days • Phase
Slide 18: PSI-7977: Pharmasset’s Lead Pyrimidine Nucleotide Analogue
PSI-7977: Pharmasset’s Lead Pyrimidine Nucleotide Analogue Excellent safety profile – 250 patients at 8 weeks or more – 1,500 patients by May 2014 High rates of cure in genotype 2/3 – 100% (10/10) with ribavirin – 60% (6/10) without ribavirin Studies in genotype 1 ongoing – Expecting Phase 2 SVR12 d
Slide 19: PSI-7977: Genotype 2/3 Phase 2 Results (ELECTRON)
PSI-7977 RBV 12 weeks PEG PSI-7977 RBV NO PEG PSI-7977 NO PEG NO RBV PSI-7977: Genotype 2/3 Phase 2 Results (ELECTRON) Time (Weeks) n/n (%) < LOD n/n (%) < LOD n/n (%) < LOD 8/11 (82%) 8/10 (80%) 8/10 (80%) 11/11 (100%) 10/10 (100%) 10/10 (100%) 11/11 (100%) 10/10 (100%) 10/10 (100%) SVR4 11/11 (100
Slide 20: Pharmasset’s Phase 3 Program
PSI-7977 400mg + RBV PSI-7977 400mg + RBV Pharmasset’s Phase 3 Program (Announced November 1, 2011) Genotype 2/3 (naïve) Genotype 2/3 (IFN intolerant) N=~250 N=~250 N=~150 N=~75 SVR12 SVR12 SVR12 SVR12 POSITRON FISSION Peg-IFN + RBV PSI-7977 placebo + RBV placebo A third Phase study to be initiated
Slide 21: Key Remaining Questions in the Treatment of HCV
Key Remaining Questions in the Treatment of HCV Will one regimen work for all genotypes or will different regimens be required for different genotypes? How many molecules or mechanisms do you need? Can ribavirin be replaced? What is the minimum duration of therapy? Can HCV be cured with once-daily t
Slide 22: Gilead’s Combined HCV Opportunity
Gilead’s Combined HCV Opportunity
Slide 23: Pharmasset and Gilead Combined HCV Efforts
Pharmasset and Gilead Combined HCV Efforts Position Us to Answer These Questions High barrier to resistance/pan-genotypic compounds will be an important component for any all-oral regimen – Pharmasset’s PSI-7977 is the most advanced, pan-genotypic compound with a high barrier to resistance – Ongoing
Slide 24: Combined HCV Clinical Portfolio
Phase PC I II III GS 9451 (NS3 protease inhibitor) * GS 5885 (NS5A inhibitor) * GS 9620 (TLR-7 agonist) * GS 6620 (nucleotide NS5B inhibitor)** GS 9669 (non-nuc NS5B site inhibitor) * Combined HCV Clinical Portfolio * Once-daily dosing PSI-7977 (nucleotide NS5B inhibitor) * PSI-938 (nucleotide NS5B
Slide 25: All-Gilead Portfolio Increases the Chance of Developing Oral Therapies
Nuc PI NS5A Non-Nuc All-Gilead Portfolio Increases the Chance of Developing Oral Therapies across Genotypes GS 5885 PSI-7977 PSI-938 GS 9451 GS 9190 GS 9669 Combination Therapies with High Potency May Further Combination Therapies with High Potency May Further Shorten Duration and Eliminate Ribaviri
Slide 26: 2012 Key HCV Milestones
2012 Key HCV Milestones Initiate and integrate Pharmasset’s Phase 3 programs – GT 2/3 programs: no change – GT 1: Phase 2 data will determine strategy Initiate clinical trial with PSI-7977 to define minimum treatment duration in GT 2/3 patients Initiate multiple enabling drug-drug interaction studie
Slide 27: In Summary
In Summary Accelerates Gilead’s strategy to develop the first all-oral regimen for the treatment of HCV Since HCV can be cured, it will be important to be first to market with an all-oral, well-tolerated regimen Pharmasset is a strategic fit with Gilead’s areas of operational excellence Opportunity
Slide 28: Gilead’s Business Prospects
Gilead’s Business Prospects Strong confidence in our core business – LTM HIV revenues of ~$6.4B in a total ~$13.0B market – LTM ~$1B in revenues coming from products outside HIV Anticipate major HIV product launches in 2012 – New revenue sources through partnerships to follow More Phase 2/3 programs
Slide 29: Financial Impact of Pharmasset Acquisition
Financial Impact of Pharmasset Acquisition Cash flows from core business will allow us to finance transaction Expect to use existing cash and $6.2 billion in incremental debt Committed to retaining investment grade credit rating – Debt/EBITDA ratio to return to 1.5x at closing + 1 year Transaction e
Slide 30: Transaction Summary
Transaction Summary Unique opportunity to dramatically change HCV disease burden worldwide Potential to extend leadership in liver disease to HCV Opportunity to parallel the commercial success in HIV Redefined potential for revenue growth in 2014 and beyond
Slide 31: Gilead to Acquire Pharmasset
Gilead to Acquire Pharmasset November 21, 2011