吉利德科學 (GILD) 2008 Q1 法說會逐字稿

Ladies and gentlemen, thank you for standing by and welcome to the Gilead Sciences first quarter 2008 earnings conference call.

At this time, all participants are in a listen only mode.

Later, we will conduct a question and answer session.

As a reminder, this conference call is being recorded today, April 16, 2008.

I would now like to turn the call over to Susan Hubbard, Vice President of Investor Relations.

Please go ahead.

Good afternoon.

Welcome to Gilead's first quarter 2008 earnings conference call.

We're pleased you could join us today.

We issued a press release this afternoon providing results for the first quarter ended March 31, 2008.

This press release is also available on our Website at www.gilead.com.

Joining me on today's call to discuss our results are John Martin, President and Chief Executive Officer; John Milligan, Chief Operating Officer and Chief Financial Officer; Kevin Young, Executive Vice President of Commercial Operations; Norbert Bischofberger, Executive Vice President of Research and Development and Chief Scientific Officer; and Matt Howe, Vice President of Finance.

John Martin will take you through the corporate highlights for the quarter.

John Milligan will review the first quarter 2008 financial results.

Norbert Bischofberger will discuss research and development program and Kevin Young will summarize our commercial milestones and provide more color on the market dynamics surrounding our various franchises.

We will then allow time at the end of this call to answer your questions.

Before I turn the call over to John Martin for the corporate update, I would first like to remind you that we will be making statements relating to future events, expectations, trends, objectives and financial results that constitute forward-looking statements within the meaning of the Private Securities Act of 1995.

These statements are based on certain assumptions and are subject to a number of risks and uncertainties that could cause our actual results to differ materially from those expressed in any forward-looking statements.

I refer you to our Form 10-K for the year ended December 31, 2007, subsequent press releases and other publicly filed SEC disclosure documents for a detailed description of the risk factors affecting our business.

In addition, please note, that we take no obligation to update or revise these forward-looking statements.

We will also be making certain references to financial measures that are on a non-GAAP basis, we provide reconciliation between GAAP and non-GAAP numbers on our Website.

I will now turn the call over to John Martin.

Thank you Susan.

Good afternoon everyone and thank you for joining us today.

We are pleased to summarize for you Gilead's accomplishments during the first quarter of 2008.

I will start by reviewing our corporate milestones for the quarter and our thoughts on some emerging data that may effect the HIV treatment landscape.

And then, turn the call over to John Milligan who will run through the financial results for the quarter.

First in February, our partner GlaxoSmithKline announced that Ambrisentan with a trade name of Volibris in Europe has received a positive opinion from the European Committee For Medicinal Products For Human Use for the treatment of pulmonary arterial hypertension in patients classified as World Health Organizational Functional Class II and III to improve exercise capacity.

GSK has stated that it expects approval by the European Commission in the coming weeks.

Also, we an announced in March that we entered into an agreement with Goldman Sachs and Company to repurchase $500 million of common stock under an accelerated share repurchase program.

We also appointed Jay Toole to the position of Senior Vice President Corporate Development.

As many of you know, Jay is a Ph.D scientist and physician who joined Gilead in 1990 and has played a leadership role in many of our key discovery and clinical research programs.

Now I'd like to take a few minutes to talk about the HIV landscape first providing a brief background on two important data sets on GSK's Abacavir that emerged during the first quarter, namely the DAD and ACTG 5202 study results.

The DAD data were presented at the Conference on Retroviruses and Opportunistic Infections in February of this year and were subsequently published in the Lancet in April.

The Data collection on Adverse events of anti-HIV Drugs, or DAD, is the name of a study that includes 11 cohorts of more than 33,000 HIV infected patients in 21 countries, including many in Europe, Australia and the United States.

It was established to follow HIV patients over the long term to assess cardiovascular related morbidity and mortality outcomes.

The data showed that the use of Abacavir is associated with a 90%, almost two fold, increase in the risk of myocardial infarction or MI.

The second study, ACTG 5202, is a U.S.

based study conducted by the AIDS Clinical Trial Group and sponsored by NIAID, comparing in part Truvada and Epzicom head to head.

The study, which commenced in late 2006, enrolled 1,800 treatment naive patients who were randomized to receive one of four regimens, Truvada or Epzicom with either Sustiva or boosted Reyataz.

The Data and Safety Monitoring Board of the Division of AIDS met in early February and reviewed preliminary study data.

The review indicated that Epzicom patients, who at screening, had high viral load of more than 100,000 copies experienced significantly higher rates of virologic failure and Grade III and IV adverse events.

These data led the ACTG to recommend to investigators that patients with high viral loads at screening, nearly half of all patients, be unblinded and counseled on what the DSMB findings could mean to them and consider switching off a regimen containing Epzicom.

The study is continued in this modified fashion.

I'm certain that there will be continued discussion about the importance and potential impact of these two data sets but at this point, we believe it would be premature and inappropriate for us to speculate on any potential regulatory actions either in the U.S.

or European Union resulting from these study results.

Gilead remains focused on our continued efforts to ensure physicians understand the profile of Truvada, either as part of Atripla or in combination with a protease inhibitor.

I would like to make a brief update on the further progress made during the quarter to increase the diagnosis and treatment of HIV in the U.S.

Specifically in Virginia, the State House of Delegates passed and the Governor signed a bill eliminating written informed concept and pretest counseling requirements, in line with the CDC recommendations.

This brings the number of states that have taken legislative steps to reduce the barriers to testing and guidelines to nine.

Additionally, similar bills have been introduced in Maryland, Massachusetts and Nebraska.

Before I turn the call over to John Milligan, I would like to say; from my perspective, Gilead has never been stronger.

With more opportunities than ever before to continue to grow our existing market of products, including; The further rollout of Atripla throughout Europe; The anticipated introduction of Aztreonam Lysine for inhalation for cystic fibrosis; and for Viread for HPV into the market; And the significant progress that we are making with our research and development programs.

And with Jay Toole taking the lead in our business development activities, we will continue to look at products and programs that complement our existing business units.

I'm very proud of the more than 3,000 employees here at Gilead and the efforts they make every day to improve the lives of patients suffering from life threatening diseases worldwide.

Now, to our financials.

John.

Thank you John.

The first quarter of 2008 was another very successful quarter.

Total revenues, which include product sales and royalty, contract and other revenues for the first quarter of 2008 were $1.3 billion.

First quarter product sales were $1.1 billion, a 30% increase compared to the first quarter of 2007 and our second consecutive quarter of surpassing $1 billion in product sales.

HIV product sales totaled $965 million for the first quarter of 2008, driven primarily by the continued strong uptake of Atripla in the United States, as well as the strong growth of Truvada in the United States and Europe.

Operating expenses were $350 million, an 18% increase over the first quarter of the prior year.

This reflects our commitment to investing in our pipeline and our geographic expansion, while keeping a sharp focus on overall expense management.

As we have noted in the past, we plan to continue to expand our operations in Europe and Kevin will speak to you in a few minutes about the progress we are making in this regard.

Our first quarter 2008 net income was $496 million or $0.51 per share on a fully diluted basis.

Non-GAAP net income per share for the first quarter of 2008, excluding the impact of after tax, stock-based compensation expense was $0.54 per share on a fully diluted basis.

A 16% increase over the first quarter of 2007 non-GAAP diluted net income per share of $0.46 per share, which also excluded the impact of after tax, stock-based compensation expense.

During the first quarter of 2008 we generated $557 million in operating cash flow and repurchased and retired 16.5 million shares of our common stock at a cost of $816 million.

Now, turning to the specific results for the first quarter.

Total revenues for the first quarter of 2008 were $1.3 billion, an increase of 22% from total revenue of $1.0 billion in the first quarter of 2007.

This performance was driven by $301 million increase in our product sales, partially offset by a $71 million decrease in our royalty contract and other revenues, compared to the first quarter of 2007.

Product sales were a record $1.1 billion for the first quarter of 2008, marking four consecutive years of quarterly product sales growth.

Product sales from the first quarter increased sequentially by 11%, as our HIV product sales continued to grow.

In terms of foreign exchange impact, $37 million of our product sales increase in the first quarter of 2008 was due to the favorable foreign currency exchange when compared to the same period in 2007 and $9 million when compared to the fourth quarter of 2007.

This favorable impact takes into account our hedging activities.

Royalties, contract and other revenues increased from the fourth quarter of 2007 by 70%, due primarily to the increase in Tamiflu royalties.

Now, turning to more specifics on product sales.

HIV product sales grew to $965 million for the first quarter of 2008, up 37% from $705 million in the first quarter of 2007 and up 12% sequentially from the fourth quarter of 2007.

Atripla contributed $324 million to our first quarter HIV product sales, as demand for this product continued to increase in the U.S.

Atripla sales accounted for 34% of our total HIV franchise sales in the first quarter of 2008.

Efavirenz' portion of Atripla, which is distributed back to BMS and reflected in the cost of goods sold line, was approximately $120 million or about 37% of Atripla sales in the first quarter of 2008.

In addition to growth in retail demand, we also observed large nonretail purchases in the first quarter of 2008 by a small number of centrally purchasing state ADAP accounts with warehousing capability.

We believe such purchases could be driven by the grant cycle for federal ADAP funds rather than being completely demand driven.

And therefore, could temper orders in the current quarter, given the likely increase in inventory levels of those accounts exiting the first quarter.

Truvada sales were $479 million for the first quarter of 2008, up 39% compared to the first quarter of 2007, of which approximately 6% was driven by the favorable foreign currency exchange impact when compared to the first quarter of 2007.

Truvada sales for the first quarter 2008 were up 7% sequentially from the fourth quarter 2007, of which approximately 1% was driven by the favorable foreign currency exchange impact when compared to the fourth quarter of 2007.

Truvada Sales accounted for approximately 1/2 of our total HIV franchise sales in the first quarter of 2008.

In the U.S.

Truvada sales were $239 million for the first quarter of 2008, up 28% compared to the first quarter of 2007.

Sequentially, U.S.

sales were up 14% , demonstrating Truvada's continued uptick as the NRTI backbone of choice when used in combination with protease inhibitors.

The growth in Truvada sales was also driven by our January 2008 price increase in the U.S., as well as the higher than usual nonretail purchases by certain state ADAP accounts as I described earlier.

In Europe, Truvada sales for the first quarter of 2008 were $218 million, as increase of 50% compared to the first quarter of 2007, driven by strong sales volume growth and the favorable foreign exchange environment.

Sequentially, Truvada sales in Europe increased 3%, mostly driven by the favorable foreign exchange.

As we discussed in our year-end earnings call, in response to an increased level of parallel trade activity in the region, effective December 1, 2007, the Company initiated a supply and management system in France to manage orders of Truvada and Viread to ensure adequate and appropriate supply of those products, commensurate with the market demand in France.

Based on results to date, we currently believe that the supply and management system has accomplished what we had hoped.

And we expect that future sales in the region will better approximate demand.

We will continue to monitor parallel trade activity to ensure continued effectiveness of our supply management system.

Viread sales were $153 million for the first quarter of 2008, down 5% from the same period in 2007, due primarily to lower sales volumes in the U.S.

and Europe, partially offset by a favorable foreign currency exchange impact.

Viread sales for the first quarter of 2008 increased 3%, compared to the fourth quarter of 2007 primarily due to a favorable foreign currency exchange environment and higher pricing.

Hepsera, for the treatment of chronic hepatitis B, generated sales of $83 million in the first quarter of 2008, up 16% compared to the first quarter of 2007, of which approximately 7% was driven by the favorable foreign currency exchange impact.

Hepsera sales for the first quarter of 2008 experienced an 8% increase sequentially driven primarily by sales volume growth in the U.S.

and certain European markets.

Sales of AmBisome were $71 million for the first quarter of 2008, an increase of 15% when compared to the first quarter of 2007, of which approximately 8% was driven by the favorable foreign currency exchange environment.

AmBisome sales increased by 5% sequentially, due primarily to increased sales volumes in certain European and international regions.

Finally, Letairis sales were $20 million for the first quarter of 2008.

Letairis was approved by the FDA for the treatment of pulmonary arterial hypertension in the United States in June, 2007 and we're very pleased with its ramp since launch.

Our royalty contract and other revenues for the first quarter 2008 decreased by increased by 38% compared to same quarter of 2007 and increased by 70% over the fourth quarter of 2007, due primarily to the royalty revenues from Tamiflu sales made by Roche.

The changes in Tamiflu sales in both comparative periods were due primarily to the fluctuations in sales related to the government pandemic planning initiatives worldwide.

Royalties received from Roche and recognized in our revenues for the first quarter of 2008 were $93 million.

These royalties, which are paid one quarter in arrears, reflect a royalty rate of approximately 22%, as applied to Roche's sales of Tamiflu during the first quarter of 2007.

As you may be aware, Roche has scheduled to report first quarter 2008 earnings tomorrow.

Now, turning to product gross margin.

Non-GAAP product gross margin for the first quarter of 2008, which excludes stock-based compensation expense, was approximately 79.1%, compared to non-GAAP product gross margin of approximately 79.9% for the same quarter of 2007 and 79.3% for the fourth quarter 2007.

The lower product gross margin, when compared to the same period last year, was primarily due to the higher proportion of Atripla sales, which carries the Efavirenz portion at 0% gross margin, partially offset by favorable overall product mix.

Turning to expenses.

Non-GAAP R&D expenses, which excludes stock-based compensation expense for the first quarter of 2008, were $138 million.

This is an increase of 27% from $109 million in the same period of last year, primarily as a result of increased clinical study expenses, as well as higher head count related to the growth in our business.

Compared to the fourth quarter of 2007, non-GAAP R&D expenses for the first quarter of 2008 decreased 18% from $169 million, primarily driven by higher license payments to Gilead collaboration partners in the fourth quarter of 2007 and partially offset by the increased clinical study expenses in the first quarter 2008, as well as higher head count.

Non-GAAP SG&A expenses, which excludes stock-based compensation expense for the first quarter of 2008 were $177 million, an increase of 33% compared to $133 million in the same period last year, due primarily to increased marketing, promotional and other expenses in support of our antiviral and cardiovascular programs, as well as higher head count, especially in our cardiovascular business.

The stronger Euro also contributed higher expenses in U.S.

dollar terms for our Euro-based operations.

On a sequential basis, non-GAAP SG&A expenses for the first quarter 2008 increased by 7% from $165 million in the fourth quarter 2007, due primarily to higher head count and other expenses to support the growth in our business.

On our first quarter 2008 revenues and pretax earnings, foreign currency exchange had a net favorable impact of $37 million and $20 million respectively when compared to the same period last year.

When the compared to the fourth quarter of 2007, the foreign currency exchange impact on our first quarter 2008 revenue was favorable by $9 million.

While the impact on our first quarter 2008 pretax earnings was not significant.

These take into account the product sales and expenses generated from outside the United States, as well as our hedging activities.

Our effective tax rate for the first quarter of 2008 was 28.0%.

Our effective tax rate for the full year of 2007 was 28.9%.

The lower effective tax rate in the first quarter of 2008, compared to full year 2007, was primarily driven by increased earnings in favorable tax jurisdictions.

Next, I would like to turn to our operating cash flow performance for the quarter and finally our net cash position at the end of the first quarter.

In the first quarter 2008, we generated $577 million in operating cash flow.

Our balance sheet at March 31, 2008, shows cash, cash equivalents and marketable securities of $2.6 billion, a decrease of $133 million when compared to the balance of approximately $2.7 billion at December 31, 2007.

We also repurchased 16.5 million shares of our common stock at a cost of $816 million this quarter, under our $3 billion share repurchase program.

This includes the $500 million of common stock that we repurchased on the accelerated share repurchase agreement that we entered into in March with Goldman Sachs and Company.

As of March 31, 2008, we had approximately $2.2 billion remaining under this share repurchase program, which will expire at the end of 2010.

We continue to actively evaluate strategic ways to use our cash and investments, continuing our efforts to pursue opportunities to end license or acquire products to compliment our own internal efforts.

We're also committed to returning cash to our stockholders, as is evident by the ongoing share repurchase program.

Now, I'd like to turn to financial guidance for the full year 2008.

You can locate all of our guidance for the 2008 year on Gilead's corporate Web site.

The only metric that we will be updating from our guidance we provided to you in January, is the effective tax rate for the full year 2008, which we now expect to the range of 28% to 29%, compared to our previous guidance of 29% to 30%.

The decrease in effective tax rate guidance is primarily related to increased revenues in favorable tax jurisdictions.

For all other metrics, we are reiterating our previous guidance.

We are pleased with the sequential quarter over quarter growth in our product revenues, particularly our HIV franchise.

As I discussed previously, however, we saw larger than usual purchases of our HIV products by a small number of U.S.

states, which we believe may be released to their ADAP budgetary cycle, which could result in significantly lower orders in the second quarter based on their current estimated inventory levels.

In addition, the exact timing of anticipated pricing approvals and subsequent launches of Atripla in European countries is still uncertain and will have an impact on our product revenues.

And finally, foreign exchange rates remain extremely volatile due to macro economic factors.

And it's difficult to predict at this point whether current rates are sustainable and how future fluctuations in these foreign exchange rates could our affect revenues and expenses for the remainder of the year.

Therefore, I'm reiterating the guidance of $4.7 to $4.8 billion in the net product revenues for 2008.

This is for direct protect sales only and does not include royalty, contract or other revenue.

As a reminder, the expense guidance we are reiterating today will be non-GAAP, which excludes the impact of stock-based compensation expense.

We are reiterating our full year non-GAAP, gross margin guidance in a range of 77% to 79%.

We're also reiterating our full year expense guidance of $610 million to $630 million for the non-GAAP R&D expenses and $710 million to $730 million for non-GAAP SG&A expenses.

Finally, regarding after tax stock-based compensation expense, we are reiterating the 2008 fully diluted EPS impact to be in the range of $0.12 to $0.14 per share.

In conclusion, our solid operating performance continues to be a validation of the significant efforts made by the more than 3,000 Gilead employees who remain committed to driving performance for our shareholders by working to improve the lives of patients around the world.

At this point, I would like to turn the call over to Norbert, who will discuss our research and development highlights for the quarter.

Thank you John.

In the first quarter of this year, Gilead achieved several significant research and development milestones, further advancing our pipeline programs.

As you know, we now have a more robust pipeline of product candidates than ever before.

So I'm going only to focus on those that have made significant advancements during the quarter.

On the antiviral front, starting with HIV, I'm very pleased to provide you an update on our Elvitegravir program.

First, with FDA's consent, we're nearing completion of the design of the Phase III program for Elvitegravir.

As we have previously communicated, we will be conducting two non-inferiority studies evaluating Elvitegravir versus Merck's Ratelgravir.

Because of the clean safety profile of the highest dose of Elvitegravir studied in the Phase II trial, the FDA requested that we consider evaluating two doses of Elvitegravir in the Phase III studies, 150 and the higher dose 300 milligrams.

With the thought that the 300 milligram dose could provide greater efficacy for patients with more advanced disease.

Based on recently obtained PK demonstrating that the 300 milligram dose does not provide substantially higher exposure than the 150 million dose, we will no longer be required to evaluate the 300 milligram dose.

And the planned Phase III studies will only have two arms.

The two studies will involved patients in the U.S.

and Europe and the primary endpoint will be the proportion of patients that achieve and maintain HIV RNA less than 50 copies per mil.

at week 48.

Due to the work we did to resolve the need to evaluate the 300 milligram dose, we now anticipate initiating these studies in the third quarter of this year.

I'm also very pleased for the first time to provide you with the details on our PK enhancer program.

As you know, Elvitegravir requires that it be boosted with 100 milligrams of Ritonavir in order to be dosed once a day.

Because of the benefit of simplified and convenient therapies to patients, as exemplified by our own Atripla, it is our goal to also co-formulate Elvitegravir into one pill, once daily, complete regimen.

The incorporation of Ritonavir, however, presents a challenge because of the requirement for a specialized formulation.

So, our strategy has been to develop a proprietary boosting agent.

One which is devoid of HIV activity, can easily be manufactured and can be given at a relatively low dose, so that co-formulation with Ritonavir and also Truvada is a possibility.

We now have that candidate, it's GS9350, which appears to fit all of these criteria.

In fact, a pilot formulation study demonstrated that we can co-formulate 9350 with Elvitegravir and Truvada into one single pill.

We have filed the IND and we're currently preparing to evaluate the safety, tolerability and metabolic profile of GS9350 in healthy volunteers.

If the results are positive, we could then move the compound into HIV infected individuals, evaluating safety and efficacy as a boosting agent versus Ritonavir.

We look forward to keeping you posted on the progress we make with this compound.

On the HCV front, following submission of data to FDA, we have now resumed screening patients in the continuation of the Phase Ib study of GS9190, our novel HCV polymerase inhibitor.

We will continue the evaluation of the 40 milligram dose, which based on a pilot QTC study in healthy volunteers appeared to have QTcF prolongations that were small and clinically manageable.

We will now finish enrolling patients in the Phase Ib study to establish the safety and efficacy of the 40 milligram dose in a sufficient number of patients to allow us to go forward into Phase II studies.

With regards to 9450, our caspase inhibitor end licensed last year, the compound is currently being evaluated as a heparo protectant in an ongoing Phase Ia study in HCV infected individuals.

We have recently added U.S.

sites to this study, which would accelerate enrollment of patients and we anticipate data on this trial by the end of the year.

We believe that this molecule may also have utility in other diseases such as fatty liver disease or NASH.

On the respiratory front, Aztreonam Lysine for inhalation is Gilead's unique drug formulation, specifically designed to achieve high lung antibiotic concentrations with a short duration of administration.

The U.S.

NDA was filed on November 16, 2007 and we have PDUFA date of September 16 of this year.

In order to make the product available to CF patients in need prior to its commercial availability, we opened up an expanded access program and now have more than 100 patients enrolled in the program.

Ahead of schedule, we announced that we filed a Marketing Authorization Application in the European Union on March 7.

And we have since also filed in Canada, where the submission was granted a priority review.

We're preparing to conduct a head to head open label study versus Tobi in the EU to support registration and plan to initiate the study shortly.

The study will not need to be completed in order to get approval in the EU but it will support a conditional approval strategy.

We will also be initiating in the second quarter of 2008, a study called the [MILE] study that will evaluate the quality of life of Aztreonam Lysine for inhalation in patients whose lung function is less compromised than patients who were involved in our Phase III pivotal studies.

Quality of life will be assessed by CFQR, a patient reported outcome tool used to measure health related quality of life for people with CF.

If the outcome from this study is positive, Aztreonam Lysine would be the only inhaled antibiotic with demonstrated benefit in earlier disease CF patients with Pseudomonas infections.

With regards to our cardiovascular franchise, the Phase III studies for Darusentan in resistant hypertension saw progress in terms of enrollment in both the DAR-311 and DAR-312 studies, which are approximately 58% and 25% enrolled respectively.

The Darusentan Data Monitoring Committee met recently and recommended that the study be continued.

We believe we are on track to complete enrollment and receive data from these studies in 2009.

I'm very pleased with the progress Gilead has made in the first quarter and look forward to informing you of further advancements of our pipeline candidates through the remainder of this year.

With that, next, Kevin will review our commercial highlights for the quarter.

Kevin?

Thank you, Norbert and good afternoon everyone.

The first quarter of 2008 was an extraordinary quarter with multiple significant events occurring.

I am referring to the results from the DAD data and the ACTG 5202 study, as John Martin previously discussed.

The treatment community's ongoing discussion and decisions around the potential impact of these data sets, along with our anticipated new product launches, will continue to make 2008 a very exciting year.

However, we believe these data did not have any impact on product revenues for the first quarter.

Before turning to our commercial performance for the quarter, I would like to remind you that the analysis of our HIV and HPV market share data in the U.S.

and Europe, we rely on the most up-to-date, third party data available to us in each market.

This data lags our financial results by one quarter.

I would first like to discuss the performance of antiviral franchise, which is compromised of our HIV and HPV marketed products.

Our U.S.

HIV franchise performance remained the best in the industry in Q4 of 2007.

And the gap between Gilead and our closest competitors continue to widen.

Atripla, built on its leadership position in the U.S., has approximately 28% of the estimated 538,000 patients treated with antiretrovirals or just over 150,000 patients were on Atripla therapy.

Atripla, together with Truvada, when prescribed as alternative therapy, with protease inhibitors continued to account for approximately eight out of 10 treatment naive patients.

In patients switching to Atripla from other therapies, over 50% were from non-Gilead based regimens.

Patients previously on Combivir continued to dominate switch patients, comprising 29% of the total patients who switched to Atripla.

Truvada continued to be the backbone of choice for antiviral therapy in the U.S.

with an estimated 169,000 patients receiving Truvada.

This represented an impressive 31% of all patients treated with antiretrovirals.

Notably, 68% of all U.S.

patients or 365,000 received the tenofovir molecule during the fourth quarter of 2007 in one of its three forms, namely, Atripla, Truvada, or Viread.

An increase from 64% from the third quarter of 2007.

We continue to make excellent progress with our HIV products in Europe.

And believe that with the continued rollout of Atripla, as well as further responses to the DAD data and the ACTD 5202 study, we will continue to build upon our strong position.

As you know, we and our partner, Bristol Myers Squibb, received European approval for Atripla in late December, 2007.

The launch is well underway in the UK, Germany and Austria.

And just last week, I'm pleased to announce that we launched in Greece.

In addition, pricing negotiations are progressing well with France, Italy, Portugal and Spain and we believe we are on track to have those finalized before the end of the third quarter.

With other European union countries rolling out over the course of the year.

The market opportunity in the big five countries continued to show robust growth.

And it was estimated that, as of the fourth quarter 2007, 256,000 patients were treated with antiretrovirals within these five markets.

This represents a 9% year over year growth rate and is comparable to the rate of growth achieved in the U.S.

Truvada has continued to build on a strong base throughout the EU and was the number one brand throughout the big five markets.

While tenofovir was the leading molecule in France, Spain, Germany and the UK during this same period.

We anticipate that we will achieve the same position in Italy during the current quarter.

Truvada plus Sustiva continued to extend their lead as the combination of choice for treatment naive patients.

Growing to 27% of treatment naive patients, which is more than double the next closest regimen of Truvada plus Kaletra of 13%.

An important potential driver to solidifying this regimen's first line position is at the British HIV Association was the first committee to react to the DAD data and the ACTG study by recently publishing revised UK HIV treatment guidelines for consultation.

If these guidelines are finalized at the end of the consultation period, on May the 16 and remain unchanged, Truvada plus Sustiva will become the preferred regimen for patients in front line use in the UK.

Of all treatment initiations on Truvada during the fourth quarter of 2007, 60% came from treatment naive patients, whilst 40% have switched from our products.

Of the patients that switched to Truvada approximately 1/2 have been on a Combivir base regimen.

In the NRTI market, Truvada continued to outperform Kivexa, known in the U.S.

as Epzicom, with a Truvada versus Kivexa market share ratio of 2.3 to 1.

This will be an important metric for us to watch as we monitor the impact of the launch of Atripla, as well as the response to the DAD data and ACTG 5202 study.

And finally on the HIV front, approximately 55% of all patients that initiated therapy began on the regimen that contained Truvada.

Turning briefly to our hepatitis franchise.

During the first quarter of 2008 in the United States, Hepsera continued to be the leading antiviral agent for the treatment of chronic hepatitis B.

As of the end of February 2008, Hepsera maintained its place as market leader with a total prescription market share of approximately 44%.

In the Gilead territories outside the U.S.

Hepsera's market share remained relatively stable despite strong competition.

Turning to Viread for HPV, in late March we were very pleased to have received our first approval of Viread for this indication in Turkey and we are currently awaiting reimbursement authorization prior to launching the product.

With an estimated 350,000 chronically infected HPV patients, Turkey represents an important market and is a country in which we have established a direct Gilead presence.

Also in March, the Committee For Medicinal Products For Human Use of the European Medicines Agency issued a positive opinion on the approval of Viread for HPV throughout the EU.

And we currently anticipate approval in the second quarter.

As we prepare for an anticipated European approval of Viread for HPV this quarter, we are excited about the timing of the European Association For the Study of the Liver Conference taking place next week in Milan, Italy.

This event will pull together key thought leaders in HPV from throughout Europe and will allow us to showcase the attributes of our HPV portfolio, particularly Viread for HPV.

There will be presentations from 10 Gilead sponsored abstracts, five of which are oral presentations.

In reviewing our commercial readiness to support a successful launch of Viread for HPV in the EU, as well as potentially the U.S.

later this year, we are far along in our prelaunch preparations.

And feel we are well positioned to support a successful rollout with our existing commercial infrastructure in both of these markets.

Now turning to our cardiovascular franchise and Letairis for the treatment of pulmonary arterial hypertension or PAH.

In an effort to share additional details on the Letairis launch and PAH market, we conducted a survey of approximately 100 prescribing physicians responsible for more than 10,000 PAH patients in late March of this year.

We are in the process of refining a robust data set in cooperation with third party source that we hope to use incoming quarters.

Until such time that we feel that data is reliable and indicative of market trends, we will continue to conduct our own market research for use on our earnings calls.

We are very pleased with the recent performance of Letairis, as well as the market dynamics we have been seeing.

During the first quarter we recorded $20 million of Letairis sales, which is very much in line with our expectations at this point in the launch.

We now have approximately 3,600 physicians enrolled in our Letairis education and access program, otherwise known as LEAP.

Of these physicians, approximately 25% represent the main treatment providers for PAH.

The remaining 75% are important part of the referral base and their continued education is essential to our efforts to expand awareness and diagnosis of this disease.

Letairis has an approximate 15% share of ERA treated PAH patients, as of our March Gilead conducted survey.

Importantly, in the centers PAH, which accounted for approximately 60% of all Letairis patients, that share was approximately 20%.

Letairis captured approximately 24% of newly diagnosed patients treated with ERA during this period, according to our survey data.

Since the launch of Letairis patients have come from three primary sources.

Patients new to therapy, patients who have switched to Letairis from other PAH treatments, namely Bosentan and PDE5 inhibitors.

And finally, patients who have had Letairis added to their existing therapy.

Monotherapy currently comprises approximately 60% of PAH treated patients, with the use of combination therapy at approximately 40%.

On the reimbursement front, access barriers have been minimal and manageable since the launch of Letairis, with comparable coverage to Bosentan on most formulas.

Letairis is covered on virtually all of the top managed care plans, as well as virtually all state Medicaid plans.

We are very encouraged with the physician feedback we have been receiving.

As their experience grows, physicians are gaining additional comfort in expanding the number of patients to whom they prescribe Letairis.

We believe we are well positioned to build upon the early success of Letairis.

And to further support the product, we will be initiating our Athena I Phase IV program shortly.

In this study, we will evaluate Letairis in patients who are poor responders to sildenafil monotherapy.

Importantly, at the upcoming American Thoracic Society Meeting, taking place in Toronto, May 16 through May 21, we will have data from four studies of Gilead products.

Two for Letairis, one from our ARIES-E study, and one from our ARIES I study.

We will also have a poster presentation on Aztreonam Lysine for inhalation from the interim data from the open label study.

And one poster from our Phase I study in CF patients of GS9310/9311, our fosfomycin/tobramycin antibiotic combination therapy.

As Norbert mentioned earlier, we have a PDUFA date of September 16 for Aztreonam Lysine with the FDA and have already begun our launch preparedness.

We believe we are in excellent position to launch the product without major additions to our existing sales force.

In closing, I am pleased with the commercial progress we have made in the first quarter.

And believe we have laid a strong foundation for growth over the remainder of 2008 and into 2009.

I will now turn the call over to the operator to begin the question and answer portion of the call.

Operator.

(OPERATOR INSTRUCTIONS) And your first question comes from the line of Meg Malloy with Goldman Sachs, please proceed.

Thanks very much.

I'd just open up with; John Milligan, could you quantify if possible, the amount of nonretail HIV demand that you think might not surface going forward?

So Meg your question is how much --?

I didn't ask it well.

But what was the anomaly in terms of dollars as best you can measure in Q1?

It's very tough to quantify that because we have observed now for the last couple years larger sales, especially in places like Florida and Texas ADAP.

So where they buy centrally and they do have warehousing capability.

So, we don't have complete insight into demand, so we don't know exactly what that number is.

So frankly, I can't quantify it for you.

We did see, if you look back historically in Q4 '06, a little bit of the Q1 '07, we did see a bump up of nonretail there and we did see some bump up here.

We don't have the March data in yet, so we don't know exactly what that looks like.

That's another factor that leads me to conclude that I shouldn't give a specific number.

I can tell you that the ADAP's, as a typical, historical percentage of our overall sales, has been right around 25%.

And then Texas and Florida are a subset of that.

So, that's about all I can tell you.

And that's 25% of U.S.

sales.

If I could follow up on that, so it doesn't sound like this bump is atypical, it sounds seasonal.

Is that a fair statement?

We think it's likely to be a seasonal pattern unless something changes within the government, yes.

Okay, thanks a lot.

Your next question comes from the line of Thomas Wei with Piper Jaffrey, please proceed.

Thanks.

I wanted to ask about the Abacavir situation, just in terms of how much of the share and how quickly you think that might be able to be taken by Truvada, how should we think about that?

Hi Thomas, it's Kevin, I'll have a go and then probably John will add to it.

As I said, we felt there was really no impact of DAD and 5202 in these first quarter results.

Certainly, from what we've fed back on a qualitative basis, I think it's going to be an impact first on new patient prescribing.

I think that's where the change will start to happen, where I think we will have to wait and see what happens in terms of switching Epzicom or Kivexa patients.

Just to give you a type of quantity, in the U.S.

there are just over 50,000 Epzicom patients.

And total Abacavir, if you add in Trizivir and Ziagen, would be just over 100,000.

So, clearly I think first and foremost it has the potential to affect Epzicom in the U.S.

and Kivexa patients in Europe.

And Thomas, It's a little bit hard to quantify the patient.

There's a lot of things that are happening, you have to remember this is an aging population.

And so, as HIV patients get older, their cardiovascular risk naturally increases, which could have a knock on effect.

But Doctors and people in the guidelines, the regulars, are just trying to get their arms around these data to try to figure out exactly what they mean right now.

So we really can't quantify that.

But I think, Thomas, the BHIVA change, which was fairly speedy is quite a significant, I think stake, in the ground around the recommendation of using Truvada plus Sustiva as first line.

And just for the transcript, that's the British HIV Association is what he is referring to.

Your next question comes from the line of Mark Schoenebaum with Bear Stearns.

Please proceed.

Okay, great.

And just for the transcript, that's Mark Schoenebaum.

Well, anyway I got to say it, congratulations on a great quarter.

It's a obviously, huge quarter for you guys.

I just had a question and I don't -- I just want to understand what was happening in Europe.

Do I hear you correctly that sequential Truvada, Viread sales were up 3% and that was FX?

Was there demand growth sequentially in Europe and do you think this Abacavir situation will affect European physicians differently than U.S.?

Mark, let me -- I'll take the second part first.

I think it has probably more potential to affect Europe, in advance of the U.S.

Again ,the British HIV guideline changes and they are very well held, not only in the UK but across Europe.

There are national guidelines that are in each country and we will have to see how they change.

Of course, DAD was a study coming out of Europe.

It was multinational but it did come out of Europe.

So, I think there's been a high level of resonance.

And as I said in the script, we have a lower Truvada to Kivexa ratio, so we have the potential to move that towards the type of ratio that we have in the U.S.

So yes, I do think that there is the potential to start that potential, gradual change in Europe.

Mark your question was about sequential growth in Europe.

If you look at, just on a dollar basis quarter over quarter, we grew 10% in Europe.

And so there's a couple of factors in there.

One, of course we alluded to in the script, which is the situation in France where there was a drawdown in inventory associated with management plan we put in place.

So that's number one.

The second part, of course, is we're launching Atripla.

So we had slightly over $14 million in sales so far even in those early countries.

And again, we presume that's all switching based on the label in Europe.

So that certainly would have had an affect on the Truvada and Viread growth rates as well.

Okay, thank you for correcting me, thank you.

Your next question comes from the line of Geoffrey Porges with Stanford and Bernstein, please proceed.

Okay, that was close.

Just a quick question to follow up on Europe.

Kevin, you've given us the numbers for the U.S.

for total tenofovir penetration.

And I think you said 68% tenofovir and by implication about 59% for emtricitabine.

Could you give us the comparable numbers for tenofovir and emtricitabine at this point in Europe for the most recent data you have?

I'd probably have to fish those out and give those later.

We will follow up with you on that.

If you don't mind Jeff.

So 59%, right, in the U.S.?

For a tenofovir molecule?

No, for emtricitabine.

Emtricitabine.

We will have to back with you on that Jeff.

Okay, thanks.

Your next question comes from the line of Yaron Werber, with Citi, please proceed.

Hi, thanks.

I asked you guys the last time kind of a three part question and I got hammered, so I'll ask you just one question this time.

Can we switch topics to Aztreonam and just give us a little bit of a sense as to how big is the market patient-wise, in the U.S.?

And maybe a little bit of a sense as to what kind of pricing or perhaps your competition is kind of -- what's the current pricing of your competition?

And perhaps why -- how would you stack according relative to that given your data?

It's Kevin.

Just in terms of patients there's about equal number of patients U.S.

to the main countries in Europe and that's about 30,000 patients in each region.

So you've got about a total of 60,000 patients.

But what you do have is somewhat a different treatment approach.

Obviously, the mainstay of treatment is Tobi, tobramycin, here in the U.S.

Whereas you've got, you have got Tobi in Europe but you also have Colistin as a treatment option that is used by European clinicians.

So, it's somewhat of a different treatment picture.

In terms of Tobi, the WAC is about $3,500 per month of therapy -- cost of therapy and that's a month's cost.

So it does depend on how the clinician is typically using Tobi in terms of the severity of the disease with the patient.

Obviously, more cycles used for more severe patients.

But there will be always be the off month interval because of the avoidance of resistance.

But in Europe the price is a lot lower, is that correct, with Tobi?

Again, I'd have to give you an exact price and follow up with on that.

There are a couple of differences between the U.S.

and Europe.

For one, there is a lot more use of just locally formulated tobramycin, so that takes up part of that market.

And also, they use a drug called Colistin or Colimycin, which is often used, again compounded by local pharmacies.

And so, the sales of Tobi itself have never been as large in Europe as they have been in the United States.

The other thing to say is, Kevin mentioned there's 30,000 patients, really that's about 30,000 cystic fibrosis sufferers and obviously there's a subset of patients and I think that's closer to 12,000 annually.

Most of whom take -- are sort of mild disease and some of whom are more severe in disease.

So, that changes the revenue numbers.

I wouldn't use 30,000 as your basis for thinking of those who would be on treatment.

Your next question comes from the line of Geoffrey Meacham with JPMorgan, please proceed.

That was close as well.

A question for you, for Kevin on Letairis.

You mentioned a 24% NRx share, can you give us that number for year end?

And then why do you think -- why isn't this a little higher given the label?

And the last part to this is what impact, if any, do you guys see on ERA's going to tier four and some parts of the private pay world?

Let me try and remember those questions, Jeff.

First of all, it's important to say that the figure I quoted was not a prescription, basically it's from our survey.

It's not even a patient record survey.

It's basically a questionnaire that we asked 100 physicians to complete.

So it's their judgment on how much ERA, PDE5 and their brands that they are using.

So it's important to qualify that.

It's essentially a survey that we did in the month of March, so it's a point in time.

So, in terms of having any retrospective data, we just don't have that.

So it was essentially a survey that we felt necessary we had to do because we're still waiting to have a third party produce high quality of data set that we get for Synovate HIV.

I can remember the third part of your question.

I still think that the ERA's are very valuable in terms of their role in treating PAH.

I've certainly met with quite a number of PAH specialists and they do consider ERA's as a first line option and I think generally, they can get those products approved from their payors.

So, my expectation is that I think for the foreseeable future, they're going to stay tier two and tier three.

Your next question comes from the line of Michael Aberman with Credit Suisse, please proceed.

Hi, guys, thanks.

I'm wondering if I could turn to the pipeline for a second.

And I wasn't really clear on 9350 development plan.

Maybe can you clarify and go a little beyond if those data are positive, what stage you can put them in into HIV patients and how quickly development can be?

Mike, maybe I should start that where we ultimately want to go.

We want to have a co-formulated single tablet, that can be given once daily, that is a complete regimen similar to Atripla.

In order to get there, that single tablet will contain Elvitegravir and our booster.

So with our PK enhancer, what we have to do first of course is to find out in healthy volunteers whether it indeed boosts the CYP3A4 substrates and that we have filed the IND and we're initiating those studies shortly.

If then we confirm that, yes, that's indeed the case, then we also accumulate some safety information in a limited number of individuals, we could then go into HIV infected individuals.

And really hopefully even with the single pill and initiate the larger study that will ultimately get us approval of Elvitegravir plus the PK enhancer co-formulated with Truvada.

But I also want to tell you of course in parallel we're also developing Elvitegravir for treatment experienced patients.

And those are those two Phase III studies that I talked about that we're initiating in the third quarter of this year.

Was this clear, Mike, have I answered your question?

Your next question actually comes from the line of William Ho with Bank of America, please proceed.

Hi guys, thanks for taking my question.

My question is related to Aztreonam Lysine in cystic fibrosis.

In choosing to run a head to head trial against Tobi, are you looking for non-inferiority or superiority?

And what are the potential risks to your market share depending on the outcome?

Yes, we did -- so the study is designed as a non-inferiority study versus Tobi.

And just to make clear, this is -- so, we filed in the European Union under a special provision that will get us approval but ultimately the Europeans in order to get full approval will want a head to head study against a standard of care, which is Tobi.

The threat to our business, I think, is minimal.

That's my opinion.

Because it is clear that Tobi, when it is repeatedly used, has very minimal efficacy.

We have seen that in our own study in '06 and we have also seen it in the Tobi studies.

Whereas patients that have not seen Aztreonam, they will have a much better response.

That's why we feel very comfortable to do a head to head study versus Tobi.

I'll also add that if you believe in the profile of your product, you should be prepared to do comparative studies.

Just like we did with Study 934 in HIV and just like we're doing with our new study, as Norbert said, in the mild cystic fibrosis setting, which again is another advance in terms of the science of developing the profile of the drug.

So, if I can confirm, we think that this provides some potential upside to the product, especially in Europe, where we're going to have to show a difference in order to be considered a credible alternative to Tobi.

And I think we have the drug to do that.

Your next question comes from the line of Sapna Srivastava, please proceed.

Yes, hi.

Just one question on the inventory level.

You mentioned in the fourth quarter that it was lower level of the contractual band.

Could you just comment on where it is now for the HIV franchise?

Sapna, it has come up about a couple days, so there was an increase in inventory.

And so, we're a little bit on the low end of sort of the mid-range.

Your next question comes from the line of Joel Sendek with Lazard Capital Market, please proceed.

Hi, thanks a lot.

I just have a follow-up question on the guidance.

So, I understand the three reasons you laid out as to why you're not increasing it but it still seems to me a little inconsistent with the DAD and ACTG results, that was an upside surprise.

And I'm wondering if what I'm missing is maybe it will just take longer for that to have an impact or is there another answer?

We're not certain how long it's going to take to have an impact.

We're pretty confident it will have an impact because these are important data sets and they're data sets that are maturing as well.

Including -- the ACTG study is an ongoing study.

So, additional things will come out of it.

The full data set hasn't been presented, so very few people even know what the results were at that interim look.

And we won't probably see that until later on this year.

So, the ability to have data sets and discussions and for physicians and patients to make decisions is going to take some time to flow through.

Obviously, the prevailing wind is quite favorable to us but the specifics aren't out there yet.

So it's difficult for us to predict the impact on sales across the world.

I would concur with John that it does take time to go from high decile opinion leader type of physicians down to the lower.

We have seen that with the Combivir switch.

And I think really DAD and ACTG is just starting to percolate down the deciles.

So, it will take time.

Your next question comes from the line of Bill Tanner with Leerink Swann, please proceed.

Thanks.

Norbert just a question on Elvitegravir.

Obviously, if PK enhancer works then that would help you overcome a major obstacle to using low dose Ritonavir in treatment naive patients.

So just curious, what would need to be done to begin to look at those patients in terms of smaller, earlier stage clinical trials?

And at what point in time or what timeline do you think you could actually be in pivotals looking at Elvitegravir plus 9340 combo in treatment naive patients?

We -- you need a certain safety database for people to become comfortable to expose a larger number of individuals in a Phase III study.

And what that number is, it depends of course what the preclinical talks is and indeed the preliminary clinical experience.

One thing that makes me feel comfortable about the PK enhancer is that we think it will end up being a fairly low dose, similar to Ritonavir or hopefully lower.

And so, I think the danger of having large safety events is somewhat diminished if you use that low of a dose.

But with Elvitegravir, we also need a certain safety database in order to go into Phase III studies.

And that safety database would be accumulated in large part in the treatment experienced patient studies that we're initiating right now.

So I'm not prepared at this point to give you timelines, simply because we're still thinking through this internally but I think I've given you a flavor of how you could construct them or think about them.

Your next question comes from the line of Maged Shenouda with UBS, please proceed.

Sure, hi, thanks.

So my question has to do with Darusentan.

Can you remind us of the design of the ongoing Phase III trials and how are you ensuring that you're getting real resistant hypertension patients in these trials?

That's a very good question.

The way that the protocol is designed, these have to be patients that are resistant -- that have resistant hypertension as defined by the JNC7, the Joint National Committee.

And that defines resistant hypertension as not being ongoing blood pressure, which is 140 over 90 in hypertensives, 130 over 80 if you have chronic kidney disease or diabetes.

Despite being on three full doses of anti-hypertensives, which has to include a diuretic.

So in other words, all our patients are at least on three full doses of anti-hypertensives.

And by the way full dose, is defined as either maximum label dose or something lesser if there's a medical reason for it.

So it's completely documented, it's completely consistent with the definition.

And that's why we feel comfortable that adding on Darusentan to that patient population, if you can show -- if we can repeat the observation from the Phase II study, where we saw about an additional 10 millimeter decrease in systolic, diastolic blood pressure, then I think we would have a very strong package for -- to send to FDA for approval.

Your next question comes from the line of Philip Nadeau with Cowen and Company, please proceed.

Good afternoon, thanks for taking my question.

Kevin, you made the remark I think in response to Thomas' question that the affects of the DAT and ACTG studies will first be seen in new patient prescribing.

Can you give us some idea of the proportion of naive patients who are started on Abacavir regimen, say as of a few months ago?

And what percent of those patients are not already contraindicated against tenofovir?

Basically in new patients the -- a percentage -- approximately about 9% of naive patients start on Epzicom.

Now, you'd have to add in the very, very small amounts that still might be there for something like Trizivir but basically I think Epzicom is the product to concentrate on.

So, it is quite a small number but obviously a lot bigger in Europe.

Our ratio of Epzicom to Travuda in the U.S.

is about 4.4 prescriptions to 1 in our favor.

And as I said in the call, it's 2.3 to 1 in Europe.

So there is that 00 we feel there is the upside for us.

Obviously, it's a smaller pool of antiretroviral treated patients in Europe but I think in terms of market share versus -- Kivexa/Epzicom, there is a higher potential there in Europe.

And Phil, I would like to add, you asked the question; How many of those patients are contraindicated to tenofovir?

Our contraindication statement in the U.S.

simply reads; If you're hypersensitive to tenofovir or any components in the formulation, then you're contraindicated.

So, we really don't have a contraindication per se.

In the warning section, it says that you have to be careful with very low clearances but those patients are very rare.

Your next question comes from the line of Ian Somaiya with Thomas Weisel Partners, please proceed.

Thanks, let me add my congratulations.

Just a question for Norbert on the 9350, the PK enhancer.

Clearly, we can see use for that drug beyond Elvitegravir.

I don't know if there are any products that you might have shelved in the pass, maybe a HIV protease inhibitor or ones that are available in the marketplace that you could potentially move forward using the BK enhancer, is there an opportunity there?

Ian, that's a very good question and that's a question we have asked ourselves as well and we're currently going through the thought process.

But clearly, as you know, there are a lot of opportunities for PK enhancers that go beyond Elvitegravir.

And they're not only in HIV, they're also in hepatitis C.

And we are looking at some of those -- the use of PK enhancer in other areas.

But I'm -- but at this point we haven't made specific decisions and I'm not prepared to give you any specific answers.

If I may, I just had an unrelated question.

I'll be honest about that.

Can you just share with us your expectations for the Darusentan data and what do you do with that drug if the data is positive in terms of marketing the molecule?

So, I can speak to the data.

The two studies that we're doing right now, the two Phase III studies are very similar to the Phase II study that was done, the 211 study that was presented at a previous meeting.

And as I said, we added on Darusentan to existing anti-hypertensive drugs.

All of the patients were on three, some of them were on four anti-hypertensive medications.

And we saw about a 10 millimeter, both systolic and diastolic, decrease in blood pressure.

So we feel very -- I personally feel very confident that we will replicate those data in our Phase III studies.

Kevin is going to --.

And if terms of sort of early thoughts on commercialization here, I think there's two critical questions really that we're working through right now in quite some detail is; What type of results will we require to launch this?

And I think it's going to require not only some focus on specialists but also some focus into some section of the primary care market.

And then secondly, I think the other question will be what type of risk map will be.

Because of course, as an ERA, it will have a risk map.

And the question then will be; Is the risk map appropriate for product profile and appropriate for this type of market?

So, that will, I think, evolve as we get to know both the market as well as we see the data from the Phase III studies.

And of course discussions with the FDA.

Your next question comes from the line of Mike King with Rodman & Renshaw, please proceed.

Good afternoon.

Let me add my congratulations.

My question is on hep.

B.

First, just simply can I confirm is August 11 the PDUFA date for Viread HPV in the U.S.?

Have you given out a specific PDUFA?

Yes, it is, Mike.

Ms.

Hubbard at this time we have run out of time for additional questions.

Thank you operator.

And thank you all for joining us today.

We appreciate your continued interest in Gilead and we look forward to providing you with updates on our future progress.