Gilead US Marketing PlanSofosbuvir

Gilead

Fazal Chaudhry

December 6, 2013

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Table of Contents

Executive Summary . . . . . . . . . 3

Mission and Brand Goals . . . . . . . . 3

Situation Analysis . . . . . . . . . 3

Key Issues & Opportunities . . . . . . . . 5

Brand Objectives & Positioning . . . . . . . 5

SWOT Analysis . . . . . . . . . 6

Brand Strategies & Tactics . . . . . . . . 7

Pre-Launch . . . . . . . . . 8

Post-Launch . . . . . . . . . 9

Brand Forecast & Assumptions . . . . . . . 11

Life Cycle Management . . . . . . . . 12

Conclusion . . . . . . . . . . 12

Appendix . . . . . . . . . . 13

References . . . . . . . . . . 18

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Executive SummaryThis is a 3-year marketing plan for Sofosbuvir. It outlines the current environment in the

Hepatitis C virus (HCV) market, the key issues and opportunities facing the Sofosbuvir brand, were our brand will be positioned in the HCV market place and the strategies and tactics that will be employed to execute a successful launch for Sofosbuvir in the United States. We are confident in the Sofosbuvir brand and confident in the success it will have in the HCV market.

Mission and Brand GoalsThe Gilead mission statement is “to discover, develop and commercialize therapeutics that

advance patient care, while challenging employees to make a difference and building a thriving worldwide enterprise.”41 The plan for Sofosbuvir meets the company mission and also has Brand Goals listed below.

• Become the preferred drug treatment regimen of choice for HCV 1-4• Market share leader in all HCV drugs• Have preferred status on all payers formularies• Support from advocacy groups, payers, physicians and Key Opinion Leaders • Become the global drug of choice for HCV 1-4 in combination therapy

Staying true to the Gilead mission and the goals, Sofosbuvir will have a successful launch and life cycle in the HCV market.

Summary of Situational AnalysisThe hepatitis C virus (HCV) is an inflammatory infection that affects the patient’s liver1,

a “vital organ that processes nutrients, filters the blood, and fights infections”19. HCV is chronic, silent and the long-term effects of the virus are infection, cirrhosis, liver cancer and liver failure 2. Many patients that are infected with HCV are asymptomatic and have no signs of infection until the disease progresses to the final stages3. The symptoms present as fatigue, nausea, anorexia, weight loss and or weakness.26 HCV is an epidemic that spreads quickly through the utilization of needles for blood transfusions, dialysis, and drug usage19,26. In 1992, testing blood for diseases like HCV aided in decreasing the rapid spread of the hepatitis C virus.19,26

Hepatitis C is a global disease, which has resulted in an estimated 170 million worldwide infections with 4.7 million new infections yearly4,26. In addition to the high transmission of infection rates, 350,000 lives are claimed by HCV yearly5. The United States alone houses about 3.2 million people infected with HCV. There are six distinct Hepatitis C genotypes or strains of the virus found throughout the world. In the US, HCV genotype (GT) 1 is the most common type of Hepatitis. Additionally, genotypes (GTs) 2 and 3 are found in the United States. In 75-85% of the persons infected, HCV becomes a chronic illness6. The asymptomatic nature of HCV skews the number of reported cases causing a variance in the number of reported cases vs the number of suspected infections in the United States. In 2011, the CDC reported 1,229 cases of HCV and the estimated number of infections was calculated to be 16,5007. In order to identify the presence of HCV in a patient, a blood test is administered. The test identifies antibodies

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fighting the infection9. There is a nucleic acid test used to identify if the HCV infection is chronic8. Once it is determined that HCV is present within the body, only then can steps be taken to administer the proper treatment as indicated by genotype.

Currently there are limited treatment options available to treat HCV infections. To guide a patient's treatment, HCV RNA PCR assay can be utilized to detect a viral response 10. Genotype (GT) 1 patients are administered peg interferon, ribavirin and some an additional protease inhibitor10 like Incivek (Telaprevir) or Boceprevir (Victrelis)20,25. (See Appendix Chart 1: Telaprevir Algorithm, Appendix Chart 2: Boceprevir Algorithm) The goal is to sustain an eradication of the virus which is called the sustained virologic response (SVR) and prevention of cirrhosis, hepatocellular carcinoma (HCC) and or decompensated liver disease requiring a liver transplant20, 24, 26. (See Appendix Table 3 Current HCV Treatment Options)

The current treatment regimens are not ideal. Victrelis indicated for HCV GT 1, administered 4 200 mg capsules 3 times daily, ribavirin is twice daily and peg interferon alpha is one time per week32. The RBV and INF are administered for 36-48 weeks, Victrelis administered for 31 to 46 weeks32. This treatment regimen has a 38% to 66% reached SVR24.32 Invitek is also indicated for HCV GT 1 in combination with ribavirin and peg interferon alpha.33 The patient is administered 3, 375mg Invitek tablets twice daily for 12 weeks in combination with ribavirin and peg interferon alpha administered from 24 to 36 weeks33. This treatment regimen has a 79% SVR in treatment naïve patients and 32% SVR in null responders33.

The limitation on current therapy in the HCV market increases the eagerness of stakeholders for a safe, effective drug. Many patients are unaware of the infection because of HCV’s asymptomatic nature and patients that are aware are choosing not to be treated because they are waiting for a safe, effective, tolerable treatment that is interferon free. Caregivers are awaiting more information about the disease so that they can better protect themselves and the person under their care14,15. Future treatment options are showing promise to patients in many different ways. Ribavirin alternatives (taribavirin) are being developed to improve the effectiveness, safety, and tolerability of therapy for chronic HCV11. There is evidence to suggest interferon-free, directly acting antiviral agent-only regimens can achieve sustained virologic response (SVR)12 for patients with GT 128, 29. (See Appendix Table 4: Current HCV Drug Competition)

Health professionals and payers have high expectations for new drugs like Sofosbuvir in

aiding the patients. Bio-Trends research group indicates, that 84% of physicians polled welcome an alternative to the current treatment regimens for HCV16. Patients are being warehoused in anticipation of a promising drug that is interferon free16. The number of warehoused patients is about 879,000 in 2013 (See Appendix Table 3: Sofosbuvir Revenue Forecast). Payers are

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increasingly anticipating the emergence of a new HCV treatment because the sequale diseases have a high economic burden17.

Sofosbuvir can meet this unmet need and can reach the market before saturation. Gilead acquired the Sofosbuvir science after the acquisition of Pharmasset for $11 billion in 2011 It is a Nucleotide NS5B inhibitor2 with a “direct-acting nucleotide polymerase inhibitor”3 that stops the RNA duplication when infected by HCV. The drug is incorporated into the RNA chain and that chain is then terminated3. Sofosbuvir is administered in addition to ribavirin and peg interferon alpha, sofosbuvir 1 400mg tablet daily, weight based RBV twice daily and peg interferon 1 time per week for 12 to 16 weeks34. Patients treated had a 90% SVR12

34. We completed marketing applications for the United States, European Union, Australia, Canada, New Zealand, Switzerland and Turkey35. The FDA tentatively approved Sofosbuvir for genotypes 1 and 4 with interferon and ribavirin for GT 2 and 3 with ribavirin35. The associated side effects include anemia, dizziness, fatigue, headache, insomnia, nausea, puritis38,39. Along with the emergence of Sofosbuvir, there are many other compounds in development and some that are awaiting final FDA approval creating the potential for fierce competition. (See Appendix Table 4: Current HCV Drug Competition)

Key Issues and OpportunitiesThe key issues Gilead is facing is the need for return on investment, lifecycle

management of the molecule by indication, and the need to clearly differentiate the brand from current and future competitors. The big challenges Gilead is facing with this brand are how to maximize patient access for all HCV patients, how to capitalize on warehoused population, and how to capitalize on product profile (efficacy, safety, duration of therapy) in addressing patient unmet needs. These challenges are in fact the opportunities that Gilead has with Sofosbuvir. Their opportunities to capitalize on these challenges (outlined in the SWOT analysis) include how to obtain first-to-market for an interferon free regimen; how to obtain first-to-market for an all-oral regimen; and how to enter the global market before competitors.

Brand Objectives and PositioningSofosbuvir will be positioned for patients with chronic hepatitis C, genotypes 1-4; it will

be part of every HCV treatment regimen because it provides the second highest SVR, improved tolerability and shorter duration of therapy compared to current treatment regimens. Based on this positioning, the brand objectives pre and post launch focus on brand awareness with clinicians. Specifically, unprompted awareness at 50 percent by end of Q4 2013 and 70 percent prompted. Post-launch, the expectation is to reach 70 percent unprompted by end of Q1 2014 and 90 percent prompted. Additionally, Gilead’s post-launch brand objectives include becoming the top HCV drug on the market by prescription sales and fasted growth in 2014. The goal is also to increase market share to 7 percent of total HCV-positive population. Continued growth will be

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driven by increased disease awareness, expanded indications by 2015, and increased access through Patient Protection and Affordable Care Act legislation.

Strengths/Weaknesses/Opportunities/ThreatsWe have some overwhelming opportunities in the marketplace. As a small

pharmaceutical company, there is flexibility to react to market changes and adapt to the current environment. Gilead is capitalizing on such an opportunity. With a dominate presence in the HIV market place with drugs Vired, Truvada, Atripla41 and have rising sales from Stribild and Complera40, strong collaborations with pharmaceutical companies showing commitment to the patients and the launching of Sofosbuvir in the HCV market place, Gilead has many things to look forward to in the future.

Figure1: Gilead Sciences SWOT Analysis

Gilead SWOTStrengths

Leader in the HIV market, driven by: Viread, Truvada, and Atripla

Strong backing by investors due to potential of Sofosbuvir

Marketing Applications for Sofosbuvir have been submitted- US, EU, Australia, Canada, New Zealand, Switzerland & Turkey

Gilead Sciences Debt to Equity Ratio is low at 0.5274

Strong corporate partnerships/collaborations with GSK, BMS & Janssen

WeaknessesLack of diversified product portfolio. Gilead’s portfolio is still heavily reliant on HIV treatment.

Substantial portion of revenue comes from 6 HIV drugs and Liver antivirals

Acquisition cost of Sofosbuvir - purchase of Pharmasset cost $11.05 Billion

Opportunities

How to capitalize on the approval of Elvitegravir for the treatment of HIV

How to maintain and increase the ROI for Gilead stockHow to capitalize on Sofosbuvir upon FDA approval

How to maintain international growth with worldwide sales

ThreatsHow to defend Gilead from the extensive generic threat being a 100% small molecular playerHow to defend from competition of new entrantsGSK dolutegravir for the treatment of HIVBaraclude (entecavir), BMS for treatment of HBV

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How to alleviate impact that the ACA will likely have on pricing & profitability in US market demanding further discounts for products

How to protect Gilead from law suits - Merck regarding patent infringement in regards to Sofosbuvir & Vertex for poaching employees and stealing data to make rival drug

Sofosbuvir is a new entrant into the HCV market, expected to launch in 2014 offering patients an alternative to treating HCV genotypes 1-435. This is a great opportunity for the patients suffering with HCV and Gilead’s portfolio to introduce Sofosbuvir with its competitive attributes.

Figure 2: Sofosbuvir SWOT Analysis

Sofosbuvir SWOTStrengths

Data from clinical trial suggest sustained virologic response (SVR), efficacy

Data from clinical trials suggest tolerable safety profile

Expected to treat several genotypes, 1-4 with combination therapies

Genotype 2 & 3 are oral therapy as opposed to injectionShorter treatment regimen, 12-16 weeks

WeaknessesHCV is a new therapeutic area for Gilead

Studied in combination with ledipasvir and ribivarin (as opposed to just on its own)

Does not treat all genotypes of Hepatitis C

Long term safety data could indicate a worse profile than expected

Extended SVR has not been studied in clinical trialsOpportunities

How to obtain first-to-market for an interferon free regimenHow to obtain first to market for an all oral regimenHow to enter the global market before competitors using established relationships like Quadri Pharma, EgyptHow to be first-to-market with Sofosbuvir’s novel MOA

Threats

How to mitigate competition from other new entrants like AbbVie, Q2 2014

How to mitigate potential delays with the FDA, approval issues and governmental delays

How to address possible late-stage failure with drugHow to prepare for potential resistance from payers and patient advocacy groups regarding premium pricing

How to prepare for potential resistance from payers under the new legislation PPACA

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Pre-Launch Strategies & TacticsSince HCV is a highly communicable disease, the brand’s first pre-launch strategy is to

increase awareness of HCV and patient unmet needs. This strategy aligns with key opportunities of how to maximize patient access for all HCV patients, how to capitalize on warehoused population and how to capitalize on product profile in addressing patient unmet needs. The primary tactic for this strategy is to partner with Centers for Disease Control (CDC) across the US eight months before launch, to do a public awareness campaign targeted to people ages 18-65 via television programming to encourage HCV testing. To ensure ease of access to testing centers, Gilead will identify a lab testing partner with labs in all 50 states with the goal of offering low-cost HCV testing to people ages 18-65. The motivator to get tested will be a message that urges people who believe they do not have the disease to think about possibly being infected and being asymptomatic. The Key Performance Indicator (KPI) for this strategy will be the willingness of external partners (CDC, labs) to partner with Gilead.

Another core pre-launch strategy is to prepare the sales team and the broaden Gilead’s organization for Sofosbuvir’s launch. This strategy aligns with the key issue of achieving return on investment as well as the need to manage the lifecycle of the molecule by indication. The plan is to prepare teams for launch by providing extensive clinical training on the current HCV landscape and the new Sofosbuvir molecule. The goal of this training is to ensure that any teams that interface with customers will be able to answer customers’ questions appropriately. Emphasis will be placed on training medical science liaisons (MSLs) and clinical specialist sales representatives (CSs) on what they can and cannot share with customers to ensure we are in regulatory alignment with the FDA. The expectation is that all of the MSLs are prepared to address unsolicited inquiries pertaining to Sofosbuvir by Q2 of 2013 and sales force will have completed the core training by Q4 of 2013 so that if Sofosbuvir receives FDA approval end of 2013, sales force will be prepared to deploy immediately. To further increase disease awareness, Gilead will develop an unbranded disease awareness campaign targeted toward people 18-65 years old to encourage HCV testing four months prior to Sofosbuvir launch. Additionally, health departments in the five states with the highest HCV infection rates will be identified for partnerships so that Gilead can help provide information to the public on how to get HCV tested; this initiative to roll out four months prior to launch. The KPI for this strategy will be sales force and MSL readiness as measured by data based multiple-choice assessments.

The third major pre-launch strategy is to prepare the US market for sofosbuvir by engaging advocacy groups and practitioners. This strategy supports the key issue of maximizing return on investment. The plan is to begin about twelve months pre-launch by identifying top HCV advocacy groups in the US that are willing to partner with Gilead. Potential partners include the American Liver Foundation, Hepatitis C Foundation, and HCV Advocate. Once those groups are identified, the goal would be to partner with them to increase disease awareness in the community. To engage the practitioners there would be advisory board sessions during the

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eight months leading up to launch. This would serve two purposes: to get feedback on potential marketing ideas as well as to understand what gastroenterologists and other specialists who treat HCV need. By having the practitioners’ perspectives, the marketing plan could be even more successful because the unmet need would be even clearer. The KPI for this strategy will be the advocacy groups’ willingness to partner with Gilead.

Figure 3: Pre-Launch Strategies, Tactics and Key Performance Indicators

Post-Launch Strategies & TacticsOnce FDA approval is granted, a major strategy will be to create awareness of

Sofosbuvir’s high SVR and its potential role in the treatment of the warehoused patient population. This strategy goes in line with the key brand opportunities of how to capitalize on the warehouse population and how to capitalize on product profile in addressing patient unmet needs. A direct-to-consumer advertising campaign will be launched immediately following FDA approval. The Key Performance Indicator (KPI) for this tactic will be how well patients are able to recall the sofosbuvir brand and its benefits. Clinical specialists will engage with prescribers as well as payers to make sure they have all the necessary resources to make appropriate treatment and formulary placement decisions. The KPI for this tactic will be how well clinicians as well as payers are able to recall the benefits of the sofosbuvir brand. To build on the partnerships that

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were established with advocacy groups in pre-launch, Gilead will continue to work with the groups with the mission of helping them interface with the community.

Another key post-launch strategy is to promote the message that sofosbuvir should be part of every HCV treatment regimen when appropriate. This strategy supports the key issue of maximizing return on investment of sofosbuvir. Marketing materials will be developed for the clinician audience. Additionally phase 2 and 3 trial data will be published in Hepatology journals with the intent of also providing prescribers with valuable journal reprints. A very critical step will be to work with the VA and AASLD to ensure treatment guidelines are updated to reflect sofosbuvir’s new role in HCV treatment. Lastly, Gilead will identify Key Opinion Leaders who can continue to convey key sofosbuvir messaging among specialists through a speaker program. (See Appendix Table 5: Key Opinion Leaders) The KPI for this overall strategy will be how receptive are clinicians to adding sofosbuvir to HCV treatment regimens when it is appropriate.

The third major post-launch strategy is to leverage managed markets to become the HCV market leader. The key tactic to maximize return on investment is to launch at a premium price. This will ensure maximum gains early on in the product’s lifecycle. Although there will probably be resistance from government and commercial payers, the plan is to demonstrate sofosbuvir’s benefits via clinical dossiers which will likely lead to preferred formulary placement. Realizing the potential implications of premium pricing on patient access, Gilead will also launch a patient co-pay assistance program. This will ensure that patients, who truly cannot afford the medication, can still have access to it. Lastly, to ensure best-in-class customer service, Gilead will contract with a vendor to provide a hotline for distributors, patients, and payers to triage and resolve all questions. The KPIs for this strategy are product sales volume, market coverage, market share, and tier placement.

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Figure 4: Post- Launch Strategies, Tactics and Key Performance Indicators

Brand Forecast & AssumptionsIn order to forecast sales for Sofosbuvir there were a number of assumptions taken into

account. First was the segmentation of the HCV+ patient population. Since this disease is asymptomatic, assumptions were made in reference to the total number of infected persons in the United States, the different genotypes, and the number of newly infected persons per year.

Secondly pricing was estimated at $85,000 per treatment regimen. This price was established above current market competitors due to Sofosbuvir’s superior efficacy, shorter duration of treatment, and interferon-free options for some genotypes (and likely all within the next 12 months). The pricing is based on a skimming strategy, allowing us to charge a premium price to maximize revenues. The strategy is applicable in markets, such as HCV, that have low price elasticity while achieving short-term profits quickly; allowing for quick amortization of research and development expenditures while creating a margin for future price reductions if necessary.30 To make Sofosbuvir a more appealing treatment option to payors, we are estimating a 30% discount to the cost of the treatment regimen. The discount will be increased to 35% in outer years as a way to compete with new treatments that are currently in competitor’s pipelines. Finally, based on the price of the drug we assume that only patients with insurance will be our customers.

Revenues are listed in the modified financial forecast, Figure 3. The complete financial forecast is included in Appendix Table 6.

Figure 3: Sofosbuvir Modified Revenue ForecastSofosbuvir Revenue Forecast 2013 2014 2015 2016

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HCV Population:

Number of genotype 1 patients in US 659,250 667,838 600,962 468,684

Number of genotypes 2&3 patients in US 219,750 222,613 200,321 156,228

Number of new HCV cases annually 16,500 16,500 16,500 16,500

Average Price per Treatment Regimen - $59,500 $59,500 $55,250

Insurance Coverage HCV Patients 56% 65% 66% 68%

Number of genotype 2&3 patients treated - 35,896 39,664 31,636

Number of genotype 1 patients treated - 21,538 59,495 47,454

Number of newly diagnosed patients treated - 2,661 3,812 3,341

Total number of patients treated - 60,095 102,970 82,432

Forecasted Sales - $3,575,631,675 $6,126,732,612 $4,554,346,551

Life Cycle ManagementLCM plays a critical role in maximizing the revenue of Sofosbuvir and should be part of

the drug development team’s focus from pre-launch through post-patent expiration. The goal is to look at the entire life of the drug from early development through post-patent expiration to maximize cumulative, lifetime sales .31

In pre-launch it was determined that Sofosbuvir would target multiple genotypes of HCV patients some with and some without interferon. Ultimately, Sofosbuvir will seek approval to treat all HCV genotypes without interferon. Additionally there may be other indications or markets for the drug. It is important for Gilead to focus on and determine the order of entry for each other indication. Geographic markets outside of the US and regulatory strategies for different international markets should also be considered and prioritized in pre-launch stages.

At product launch it is critical to have a rapid uptake of the product to maximize revenues. At this time it is also important to simultaneously be working to evergreen the brand. This may include new formulations, indications and/or combination therapies.

As patent expiration approaches Gilead should look for the optimal time to reduce marketing spend without negatively impacting the brand and sales. Upon expiration of the patent, opportunities to extend the product life may include price discounting, creative contracting with payers, the ability to switch to an OTC brand and/or the ability to sell profitably in the generic market. The result is a product offering long-term profits over a long product life.

Conclusion

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HCV medicines that were once revolutionary in their time are next to being obsolete in world of medicine today. Current HCV treatment therapies have so many limitations as to what they can do and accomplish. 84% of physicians polled welcome an alternative to the current treatment regimens for HCV16. Patients that were longing for a new treatment can finally have what they desire; and for those patients that hid from their current treatment therapies and warehoused themselves, they can finally come out and battle HCV with what Gilead has to offer, Sofosbuvir.

Sofosbuvir has a tolerable safety profile than that of its competitors, has a shorter duration of therapy, treats genotypes 1-4 and patients treated with sofosbuvir had a 90% SVR rate12

34. This small criterion alone beats any of the competitors on the current market today. Sofosbuvir is also the only medicine that will be able to market an interferon free regimen. Out of the 350,000 lives that are claimed per year, sofosbuvir release can drastically alter the statistics and reduce the number of deaths that are caused by HCV per year. The future of treatment lies within sofosbuvir and with it can we cure and reduce the number of deaths caused by HCV.

AppendixAppendix Chart 1: Telaprevir Algorithm36

Appendix Chart 2: Boceprevir Algorithm37

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Appendix Table 3: Current HCV Treatment Options

Current Treatment Options HCV GT 123

Drug Generic Name

Drug Class MOA Preparation Dosing Indication Cost

Rebetol, Copegus21

Ribavarin antiviral unknown 200 mg capsule

1000-1200 mg daily

chronic HCV

Victrelis22,

24, 27

Boceprevir NS3/4A protease inhibitor

Binds reversibly

to the active site

of the HCV NS3

200 mg capsule

800 mg TID

chronic HCV GT 1

~ 1100 per week

Pegasys23 Pegylated interferon

alpha, beta,

gamma

Boost immune response

180 U/5 ML Weekly injection

acute/chronic HCV

Incivek25 Telaprevir NS3/4A protease inhibitor

375 mg capsule

6 capsules/ day

HCV in combination therapy w/ RBV and Interferon

~ 4100 per week

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Appendix Table 4: Current HCV Drug CompetitionDrug Company Class Phase Regimen Launch

GS-5816 Gilead N55A InhibitorPhase

2tbd nd

Sovaprevir (ACH-1625)

Achillion NS3/4A protease inhibitorPhase

2once daily n.d.

ACH-2684 Achillion Protease inhibitorPhase

2once daily n.d.

Mericitabine RG 7128

Roche/ PharmassetNS5B RNA-dependent RNA

polymerase inhibitorPhase

2500 mg, 1,000 mg, 1,500

mg Twice-dailyexpected

2016

Danoprevir RG7227Roche/ Pharma Research and Early Development

NS3/4A proteasePhase

2

100 mg (boosted with 100 mg of ritonavir),

Twice-daily

expected 2016

Setrobuvir RG7790Roche/ Pharma Research and Early Development

Phase 2

200 mg, Twice-dailyexpected

2016

Simeprevir (TMC-435)

Janssen Pharmaceutical NS3/4A protease inhibitorPhase

3150 mg capsule once

dailyn.d.

Sofosbuvir (GS-7977) Gilead Sciences nucleotide NS5B inhibitorPhase

3400 mg capsule once

daily41621

Faldaprevir (BI-201335)

Boerhinger Ingelheim NS3/4A protease inhibitorPhase

3120 mg capsule once

dailyn.d.

Asunaprevir (BMS-650032)

Bristol-Myers Squibb NS3 protease inhibitorPhase

3200 mg, Twice-daily

expected 2015

Leidipasiv (GS-5885) Gilead N55A InhibitorPhase

3once-daily fixed dose

Expected June -2014

Vaniprevir (MK-7009)

Merck Protease InhibitorPhase

3300 mg twice daily or 600-800 mg once daily

41346

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Daclatasvir BMS 790052

Bristol-Myers Squibb NS5A replication inhibitorPhase

3once daily n.d.

ABT-333, ABT-450/ritonavir,

ABT-267AbbVie

non-nucleoside polymerase inhibitor, protease inhibitor,

NS5A inhibitor

Phase 3

twice daily and once daily

Expected 2014

Appendix Table 5: Key Opinion Leaders42

Key Opinion LeadersUnited States

Sameh Boktor, MD, Adult Viral Hepatitis Prevention Coordinator, Bureau of Epidemiology, Pennsylvania Department of Health, Harrisburg, PA, USA

Ramnik J. Xavier, MD, PhD, Director of Hepatology, Medicine Service, Massachusetts General Hospital, MA, US

Dr. Eric J. Lawitz, President and Medical Director at Alamo Medical Research, Texas, US

Paul J. Pockros, MD, Head, Division of Gastroenterology and Hepatology, Scripps Clinic, CA, US

Mitchell Shiffman, MD, Head of the Liver Institute of Virginia, Virginia, US

International Organizations

Department of Hépato-Gastroenterologie, Centre Hospitalier Universitaire de Nancy-Brabois, Vandoeuvre-lès-Nancy, France

Professor of Medicine at the University of Vienna, Vienna General Hospital, Wien, Austria

Professor at Hôpital Saint Eloi, Montpellier, France

Co-lead of HCV Research UK, MRC Virology Unit, Glasgow, Scotland

Professor of Medicine and Chief of the Department of Medicine, J.W. Goethe University Hospital, Frankfurt, Germany

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Appendix Table 6: Revenue Forecast

Sofosbuvir Revenue ForecastKey Assumptions

2013 Baseline 2014 2015 2016

Population:

Number of chronic HCV patients in US 3,300,000 3,316,500 3,222,905 3,086,435

Number of diagnosed US patients 1,229,000 1,290,450 1,261,378 1,187,976

Number who have been treated 350,000 400,000 460,095 563,065

Number of remaining diagnosed patients 879,000 890,450 801,283 624,912

Number of genotype 1 patients in US 659,250 667,838 600,962 468,684

Number of genotypes 2&3 patients in US 219,750 222,613 200,321 156,228

Number of new HCV cases annually 16,500 16,500 16,500 16,500

Pricing:

Sticker Price per regimen NA $85,000 $85,000 $85,000

Average price discount to payers NA 30% 30% 35%

Average price per treatment regimen NA $59,500 $59,500 $55,250

Insurance Coverage (HCV+ patients):

Private insurance, % 35% 38% 40% 43%

Military/state/government insurance, % 10% 9% 8% 7%

Medicare/Medicaid, % 18% 18% 18% 18%

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% of HCV+ patients with insurance coverage 63% 65% 66% 68%

Patients:Genotypes 2&3 warehouse target (interferon-free) NA 25% 30% 30%

Number of genotype 2&3 patients treated NA 35,896 39,664 31,636

Genotype 1 warehouse target NA 5% 15% 15%

Number of genotype 1 patients treated NA 21,538 59,495 47,454

Number of new cases treated NA 25% 35% 30%

Number of newly diagnosed patients treated NA 2,661 3,812 3,341

Total number of patients treated NA 60,095 102,970 82,432

Forecasted Sales: $3,575,631,675 $6,126,732,612 $4,554,346,551

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3. (2013, July 1). Hepatitis c. Retrieved from World Health Organization website: http://www.who.int/mediacentre/factsheets/fs164/en/

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5. (2013, July 1). Hepatitis c. Retrieved from World Health Organization website: http://www.who.int/mediacentre/factsheets/fs164/en /

6. (2013, May 10). Testing for HCV Infection: An Update of Guidance for Clinicians and Laboratorians. Retrieved from: http://www.cdc.gov/hepatitis/hcv/PDFs/hcv_flow.pdf

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7. (2013, August 19). Viral hepatitis statistics & surveillance. Retrieved from Centers for Disease Control and Prevention website: http://www.cdc.gov/hepatitis/Statistics/index.htm

8. (2013, July 1). Hepatitis c. Retrieved from World Health Organization website: http://www.who.int/mediacentre/factsheets/fs164/en /

9. (2013). Hepatitis Health Center. Retrieved from Web MD website: http://www.webmd.com/hepatitis/hepc-guide/default.htm

10. Yee, H., & Chang, M. (2012). Update on the management and treatment of hepatitis c virus infection: Recommendations from the department of veterans affairs hepatitis c resource center program and the national hepatitis c program office. Am J Gastroenterol, 107(5), 669-689. Retrieved from http://www.nature.com/ajg/journal/v107/n5/abs/ajg201248a.html

11. Cholongitas, E., & Papatheodoridis, G. (2008). Review article: Novel therapeutic options for chronic hepatitis c. Medscape, 27(10), 866-884. Retrieved from Review Article: Novel Therapeutic Options for Chronic Hepatitis C

12. Yee, H., & Chang, M. (2012). Update on the management and treatment of hepatitis c virus infection: Recommendations from the department of veterans affairs hepatitis c resource center program and the national hepatitis c program office. Am J Gastroenterol, 107(5), 669-689. Retrieved from http://www.nature.com/ajg/journal/v107/n5/abs/ajg201248a.html

13. (2013, September) Hepatitis C: Significant unmet need fuels pharma development and deals. Pharma biotech support services Kantar Health. Retrieved fromhttp ://www.kantarhealth.com/blog/michael-fronstin/michael-fronstin/2012/07/26/ hepatitis-c-significant-unmet-need-fuels-pharma-development-and-deals

14. Porter, L. K. (2006, ). For family and friends: Caring for someone with hepatitis c. Retrieved from HCV Advocate website: http://www.hcvadvocate.org/hepatitis/factsheets_pdf/Friends_caring.pdf

15. J. Pediatr Gastroenterol Nutr. 2009 March: 48(3): 341-347. doi: 10.1097/IMPG.0b013e318185998f

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16. Chris Comfort; November 15, 2012 :Bio Trends News & Events; Many Physicians who Treat HCV Have Begun “Warehousing.” www.bio-trends.com/News-and-Events/Press-Releases/hepatitis-C-111512

17. www.bio-trends.com/News-and-Events/Press-Releases/hepatitis-C-111512

18. (2012, Dec.) American Journal of Managed Care. Economic burden and current managed care challenges associated with hepatitis C. 18(14 Suppl):S350-9.

19. (2010, July). Hepatitis c. Retrieved from Centers for Disease Control and Prevention website: http://www.cdc.gov/hepatitis/hcv/pdfs/hepcgeneralfactsheet.pdf

20. Dhawan, V. K., & Katz, J. (2013, November 25). Hepatitis c treatment and management. Retrieved from Medscape website: http://emedicine.medscape.com/article/177792-treatment

21. (2011, August). Copegus (ribavirin) tablets. Retrieved from FDA: US Food and Drug Administration website: http://www.accessdata.fda.gov/drugsatfda_docs/label/2011/021511s023lbl.pdf

22. (2012, July 24). Victrelis (boceprevir) information. Retrieved from FDA: US Food and Drug Administration website: http://www.fda.gov/Drugs/DrugSafety/PostmarketDrugSafetyInformationforPatientsandProviders/ucm291169.htm

23. (2011, May 25). Viral hepatitis therapies. Retrieved from FDA: US Food and Drug Administration website: http://www.fda.gov/ForConsumers/ByAudience/ForPatientAdvocates/ucm151494.htm

24. (2012) CLINICAL AND SYSTEMATIC REVIEWS. Retrieved from http://www.idsociety.org/uploadedFiles/IDSA/Hepatitis_C/For_IDSA_Members/2012%20HCV-guidelines.pdf September 20, 2013

25. Palm, M. (2013, April). Incivek (telaprevir) fact sheet. Retrieved from TAG: Treatment Action Group website: http://www.treatmentactiongroup.org/hcv/factsheets/incivek-telaprevir

26. Wilkins, T. (2010, June 1). Hepatitis C: diagnosis and treatment. American Family Physician. Retrieved from http://www.aafp.org/afp/2010/0601/p1351.html

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27. (2013) Triple Therapy for Hepatitis C Can Be Cost-Effective – retrieved from : http://www.pharmacytimes.com/news/Triple-Therapy-for-Hepatitis-C-Can-Be-Cost-Effective#sthash.mLodfdph.dpuf September 22, 2013

28. Carroll, J. (2013, November 18). Abbvie steps closer to fda filing as first hep c phiii delivers promising results read more: Abbvie steps closer to fda filing as first hep c phiii delivers promising results. Retrieved from Fierce Biotech website: http://www.fiercebiotech.com/story/abbvie-steps-closer-fda-filing-first-hep-c-phiii-delivers-stellar-results/2013-11-18

29. Hoff, E., & Boix, J. (2013, November 18). Abbvie releases first of six phase iii results from investigational all-oral, interferon-free, 12-week regimen, showing 96 percent svr12 in genotype 1 hepatitis c patients new to therapy. Retrieved from AbbVie website: http://abbvie.mediaroom.com/2013-11-18-AbbVie-Releases-First-of-Six-Phase-III-Results-from-Investigational-All-Oral-Interferon-Free-12-week-Regimen-Showing-96-Percent-SVR12-in-Genotype-1-Hepatitis-C-Patients-New-to-Therapy

30. Smith, Mickey C. Pharmaceutical Marketing: Strategy and Cases. Binghamton: Pharmaceutical Products Press. 1991.

31. Bernard, S. Rethinking Product Lifecycle Management. Pharmaceutical Executive. February 1, 2013. http://www.pharmexec.com/pharmexec/article/articleDetail.jsp?id=805006 November 13, 2013.

32. (2013). Victrelis boceprevir. Retrieved from Merck website:

http://www.victrelis.com/boceprevir/victrelis/hcp/efficacy/previously-treated/overall/index.jsp

33. (2013, November). Incivek telaprevir. Retrieved from Vertex website: http://www.incivek.com/

34. O'Brien, P., & Miller, C. (2013, November 2). Gilead announces new sustained viral response data for sofosbuvir-based regimens in genotype 3-infected hepatitis c patients. Retrieved from Gilead website: http://www.gilead.com/news/press-releases/2013/11/gilead-announces-new-sustained-viral-response-data-for-sofosbuvirbased-regimens-in-genotype-3infected-hepatitis-c-patients

35. O'Brien, P., & Miller, C. (2013, October 25). Fda advisory committee supports approval of gilead’s sofosbuvir for chronic hepatitis c infection. Retrieved from Gilead website:

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35. http://www.gilead.com/news/press-releases/2013/10/fda-advisory-committee-supports-approval-of-gileads-sofosbuvir-for-chronic-hepatitis-c-infection

36. Yee, H., & Chang, M. (2012). Update on the management and treatment of hepatitis c virus infection: Recommendations from the department of veterans affairs hepatitis c resource center program and the national hepatitis c program office. Am J Gastroenterol, 107(5), 669-689. Retrieved from http://www.nature.com/ajg/journal/v107/n5/abs/ajg201248a.html

37. Am J Gastroenterol advance online publication, 24 April 2012; doi: 10.1038/ajg.2012.48 Treatment Algorithm for protease inhibitor BoceprevirO'Brien, P., & Miller, C. (2013, February 4). Gilead announces sustained virologic response rates from two phase 3 studies of sofosbuvir for hepatitis c. Retrieved from Gilead website: http://www.gilead.com/news/press-releases/2013/2/gilead-announces-sustained-virologic-response-rates-from-two-phase-3-studies-of-sofosbuvir-for-hepatitis-c

38. O'Brien, P., & Miller, C. (2013, April 23). Data from phase 3 studies of gilead’s sofosbuvir for hepatitis c to be presented at 48th annual easl meeting; findings published online today in the new england journal of medicine. Retrieved from Gilead website: http://www.gilead.com/news/press-releases/2013/4/data-from-phase-3-studies-of-gileads-sofosbuvir-for-hepatitis-c

39. Stynes, T. (2013, October 29). Gilead net up on newer hiv drug sales growth. Retrieved from Wall Street Journal website: 39. http://online.wsj.com/news/articles/SB10001424052702304200804579166093251483608

40. (2013). Retrieved from Gilead website: http://www.gilead.com/about

41. Bombourg, N. (2012, November 29). Kol insight: Hepatitis c: Hhe race for the first interferon-free regimen. Retrieved from PR Newswire website: 41. http://www.prnewswire.com/news-releases/kol-insight-hepatitis-c-the-race-for-the-first-interferon-free-regimen-181394421.html

Appendix Table 2 ReferencesDaclatasvir BMS 790052

Bennett, S. (2013, April 28). Gilead-bristol hepatitis c drug combo cures all in study. Retrieved from Bloomberg website: http://www.bloomberg.com/news/2013-04-27/gilead-bristol-hepatitis-c-drug-combo-cures-100-in-study.html

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Franciscus, A. (2013, September 11). Hepatitis c treatments in current clinical development. Retrieved from HCV Advocate News and Pipeline Blog website: http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html

Swan, T., & Levin, J. (2013, June). Hepatitis c drug development catapults onward. Retrieved from Pipeline Report website: http://www.pipelinereport.org/2013/hcv

(2012, March 8). Pipeline asset update for daclatasvir (dcv; bms-790052). Retrieved from Bristol Myers Squibb website: http://www.bms.com/research/investigational/hepatitis/Pages/DCV-BMS-790052.aspx

(2012, April 18). Dual oral therapy with ns5a inhibitor daclatasvir (bms-790052) and ns3 protease inhibitor asunaprevir (bms-650032) in hcv genotype 1b-infected null responders or patients ineligible/intolerant to peginterferon/ribavirin. Retrieved from National Aids Treatment Advocacy Project website: http://www.natap.org/2012/EASL/EASL_27.htm

Sovaprevir (ACH-1625)Izlar, M. C., & Langreth, R. (2013, July 2). Achillion hepatitis c drug trial on hold on liver concern. Retrieved from Bloomberg website: http://www.bloomberg.com/news/2013-07-01/achillion-hepatitis-c-drug-trial-on-hold-on-liver-concern.html

Manocha, V. (2013, July 1). Update 1-fda places clinical hold on achillion's hep c drug, shares plunge. Retrieved from Reuters website: http://www.reuters.com/article/2013/07/01/achillion-fda-hepcdrug-idUSL3N0F73ME20130701

(2012, August 28). Hcv protease inhibitor - sovaprevir (ach-1625). Retrieved from Achillion website: http://www.achillion.com/ACH_1625

(2012). Sovaprevir. Retrieved from Achillion website: http://www.achillion.com/PL/pdf/Sum08_1625.pdf

ACH-2684(2013, August 29). Hcv protease inhibitor ach-2684. Retrieved from Achillion website: http://www.achillion.com/ACH_2684

Franciscus, A. (2013, September 11). Hepatitis c treatments in current clinical development. Retrieved from HCV Advocate News and Pipeline Blog website: http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html

Mericitabine RG 7128(2013, July 25). Pharmaceuticals pipeline. Retrieved from Roche website:http://www.roche.com/index.htm

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Franciscus, A. (2013, September 11). Hepatitis c treatments in current clinical development. Retrieved from HCV Advocate News and Pipeline Blog website: http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html

(2012, July 16). Mericitabine (formerly rg7128). Retrieved from Pipeline Reportwebsite: http://www.pipelinereport.org/browse/hcv-treatment/mericitabine

Danoprevir RG7227(2013, July 25). Pharmaceuticals pipeline. Retrieved from Roche website:http://www.roche.com/index.htm

Franciscus, A. (2013, September 11). Hepatitis c treatments in current clinical development. Retrieved from HCV Advocate News and Pipeline Blog website: http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html

(2012, July 16). Danoprevir/r (rg7227). Retrieved from Pipeline Report website: http://www.pipelinereport.org/browse/hcv-treatment/danoprevir

Setrobuvir RG7790(2013, July 25). Pharmaceuticals pipeline. Retrieved from Roche website:http://www.roche.com/index.htm

Franciscus, A. (2013, September 11). Hepatitis c treatments in current clinical development. Retrieved from HCV Advocate News and Pipeline Blog website: http://www.hcvadvocate.org/hepatitis/hepC/HCVDrugs.html

(2012, July 16). Danoprevir/r (rg7227). Retrieved from Pipeline Report website: http://www.pipelinereport.org/browse/hcv-treatment/danoprevir

Simeprevir (TMC-435)(2013, May 21). Primary efficacy and safety findings from phase 3 study of janssen's simeprevir administered once daily demonstrate sustained virologic response in treatment-experienced genotype 1 chronic hepatitis c adult patients. Retrieved from Johnson & Johnson website: http://www.investor.jnj.com/releasedetail.cfm?ReleaseID=766263

(2013, May 21). Simeprevir. Retrieved from Medscape website: http://www.medscape.com/viewarticle/805259_2

Sofosbuvir (GS-7977)(2013, June 7). Gilead announces u.s. fda priority review designation for sofosbuvir for the treatment of hepatitis. Retrieved from Gilead website: http://www.gilead.com/news/press-releases/2013/6/gilead-announces-us-fda-priority-review-designation-for-sofosbuvir-for-the-treatment-of-hepatitis-c

Grogan, K. (2013, April 25). Impressive cure rates for gilead hcv drug sofosbuvir. Retrieved from Pharma Times Online website:

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http://www.pharmatimes.com/Article/13-04-25/Impressive_cure_rates_for_Gilead_HCV_drug_sofosbuvir.aspx

(2013, April 10). Gilead files oral hepatitis c drug sofosbuvir in us. Retrieved from PM Live website: http://www.pmlive.com/pharma_news/gilead_files_oral_hepatitis_c_drug_sofosbuvir_in_us_470721

Faldaprevir (BI-201335)(n.d.). Faldaprevir. Retrieved from Medscape website: http://www.medscape.com/viewarticle/803815

(2013, April 24). New hcv drugs - easl & beyond. Retrieved from National AIDS treatment advocacy website: http://www.natap.org/2013/EASL/EASL_87.htm

Asunaprevir (BMS-650032)(2013, April 29). Daclatasvir and asunaprevir are a promising oral treatment for patients with the hepatitis c. Retrieved from LGM Pharma Blog website: http://www.lgmpharma.com/blog/daclatasvir-and-asunaprevir-are-a-promising-oral-treatment-for-patients-with-the-hepatitis-c-virus/

AS Lok, DF Gardiner, C Hezode,et al. Sustained virologicresponse in chronic HCV genotype (GT) 1-infected null responders with combination of daclatasvir (DCV; NS5A inhibitor and asunaprevir (ASV; NS3 inhibitor) with or without peginterferon alfa-2a/ribavirin (PEG/RBV). 63rd Annual Meeting of the American Association for the Study of Liver Diseases (AASLD 2012). Boston, November 9-13, 2012. Abstract 79.

Leidipasiv (GS-5885)Investors: Gilead News Release. (n.d.).Gilead | Investors | Investor Relations Home. Retrieved September 28, 2013, from http://investors.gilead.com/phoenix.zhtml?c=69964&p=irol-newsArticle_Print&ID=1814329&highlight=

sofosbuvir + ledipasvir () UKMi New Drugs Online Database. (n.d.). Welcome to UKMi National Medicines Information. Retrieved September 28, 2013, from http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=5790

Vaniprevir (MK-7009)Vaniprevir with pegylated interferon alpha-2a and... [Hepatology. 2012] - PubMed - NCBI. (n.d.). National Center for Biotechnology Information. Retrieved September 28, 2013, from http://www.ncbi.nlm.nih.gov/pubmed/2247

Vaniprevir Plus PegIntron®/Ribavirin in Japanese Participants With Chronic Hepatitis C Who Are Non-responders to Previous Treatment (MK-7009-045 AM2) - Full Text View - ClinicalTrials.gov. (n.d.).Home - ClinicalTrials.gov. Retrieved September 28, 2013, from http://clinicaltrials.gov/show/NCT01405560

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Incivek (TelaprevirINCIVEK® (telaprevir) 375mg Tablets. (n.d.). INCIVEK® (telaprevir) 375mg Tablets. Retrieved September 28, 2013, from http://www.incivek.com/

Incivek set to break record for fastest product launch. (2011, November 3).Vantage. Retrieved September 28, 2013, from www.epvantage.com/Universal/View.aspx?type=Story&id=261529&isEPVantage=yes

Victrelis (Boceprevir) Victrelis Side Effects Center. (n.d.).RxList. Retrieved September 28, 2013, from http://www.rxlist.com/victrelis-side-effects-drug-center.htm

Feuerstein, A. (2011, June 28). Vertex Tops Merck in Early Hep C Drug Launch.National AIDS Treatment Advocacy Project - NATAP - HIV - AIDS Treatment Information. Retrieved September 28, 2013, from http://www.natap.org/2011/newsUpdates/062911_01.htm

AlisporivirHighleyman, L. (2011, April 3). 6th Annual Meeting of the European Association for the Study of the Liver.hivandhepatitis. Retrieved September 28, 2013, from http://www.hivandhepatitis.com/2011_conference/easl2011/docs/0408_2010_a.html

alisporivir () UKMi New Drugs Online Database. (n.d.). Welcome to UKMi National Medicines Information. Retrieved September 28, 2013, from http://www.ukmi.nhs.uk/applications/ndo/record_view_open.asp?newDrugID=4968

GS-5816Highleyman, L. (2013, June 19). EASL 2013: NS5A Inhibitor GS-5816 Looks Good in Phase 1 Study, Now In Phase 2 | HCV Treatment. hivandhepatitis.com. Retrieved September 28, 2013, from http://www.hivandhepatitis.com/hepatitis-c/hepatitis-c-topics/hcv-treatment/4149-easl-2013-ns5a-inhibitor-gs-5816-looks-good-in-phase-1-study-now-in-phase-2

Pipeline. (n.d.). Gilead. Retrieved September 28, 2013, from http://www.gilead.com/research/pipeline

Appendix Table 3 References(2013, August 19). Viral hepatitis statistics & surveillance. Retrieved from Centers for Disease Control and Prevention website: http://www.cdc.gov/hepatitis/Statistics/index.htm

(2013, August 19). Table 4.1 reported cases of acute, hepatitis c, by state ― united states, 2007–2011. Retrieved from Centers for Disease Control and Prevention website: http://www.cdc.gov/hepatitis/Statistics/2011Surveillance/Table4.1.htm

Taylor, P. (2013, October 28). Gilead's sofosbuvir aces fda advisory committee. Retrieved from PM Live website:

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http://www.pmlive.com/pharma_news/gileads_sofosbuvir_aces_fda_advisory_committee_513376

(2013, January 10). Hepatitis c treatment. Retrieved from US Department of Veterans Affairs website: http://www.hepatitis.va.gov/provider/reviews/hcv-treatments.asp

Beasley, D. (2013, October 29). Update 2-gilead posts 17 pct profit rise, readies for hcv launch. Retrieved from Reuters website: http://www.reuters.com/article/2013/10/29/gilead-results-idUSL1N0IJ26020131029

(2013, November 11). Will gilead sciences be able to continue its growth trajectory? Retrieved from Seeking Alpha website: http://seekingalpha.com/article/1828292-will-gilead-sciences-be-able-to-continue-its-growth-trajectory

Pollack, A. (2011, May 13). Merck’s hepatitis c drug wins f.d.a. approval. Retrieved from The New York Times website: http://www.nytimes.com/2011/05/14/business/14drug.html?_r=0

Harper, M. (2012, May 10). Inside the secret world of drug company rebates. Retrieved from Forbes website: http://www.forbes.com/sites/matthewherper/2012/05/10/why-astrazeneca-gives-insurers-60-discounts-on-nexiums-list-price/

Stepanova, M., Kanwal, F., El-Serag, H. B., & Younossi, Z. M. (2011). Insurance status and treatment candidacy of hepatitis c patients: Analysis of population-based data from the united states. Hepatology, 53(3), 737-745. Retrieved from http://onlinelibrary.wiley.com/doi/10.1002/hep.24131/pdf