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Gilead Sciences Inc. (NASDAQ:GILD)

Q4 2008 Earnings Call

January 27, 2009 4:30 pm ET

Executives

Susan Hubbard - Vice President of IR

John Martin - Chairman and CEO

John Milligan - President and COO

Kevin Young - EVP, Commercial Operations

Norbert Bischofberger - EVP, R&D and CSO

Robin Washington - SVP and CFO

Analysts

Mark Schoenebaum - Deutsche Bank

David Risinger - Bank of America

Thomas Wei - Piper Jaffray

Geoffrey Meacham - JPMorgan

Yaron Werber - Citi

Michael Aberman - Credit Suisse

Geoff Porges - Bernstein

Bill Tanner - Leerink Swann

Maged Shenouda - UBS

Phil Nadeau - Cowen and Company

Ian Somaiya - Thomas Weisel

Steven Harr - Morgan Stanley

Joel Sendek - Lazard

Jason Kantor - RBC Capital Markets

Bret Holley - Oppenheimer

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences fourth quarter and full year 2008 Earnings Call. At this time, all participants are in listen-only mode. Later, we will conduct a question-and-answer session. As a reminder this conference call is being recorded today, January 27th, 2009.

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

Susan Hubbard

Good afternoon and welcome to Gilead's fourth quarter and full year 2008 earnings conference call. We're pleased you could join us today. We issued a press release this afternoon providing results for our fourth quarter and year-ended December 31st, 2008. This press release is available on our website at www.gilead.com. We've also posted slides that outline the topics discussed on today's call.

Joining me on the call today to discuss our results are John Martin, Chairman and Chief Executive Officer, John Milligan, President and Chief Operating Officer, Kevin Young, Executive Vice President of Commercial Operations, Norbert Bischofberger, Executive Vice President of Research and Development and Chief Scientific Officer, and Robin Washington, Senior Vice President and Chief Financial Officer. We will keep prepared comments brief to allow more time for Q&A.

Before I turn the call over to John Martin, I would first like to remind you that we would 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 Litigation Reform 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 statement.

I refer you to our Form 10-K for the year-ended December 31, 2007, Form 10-Q for the first, second and third quarters of 2008, 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 undertake 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 a reconciliation between GAAP and non-GAAP numbers, on our website.

I will now turn the call over to John Martin.

John Martin

Thank you, Susan. Good afternoon everyone and thank you for joining us today. In short, 2008 was another very successful year for Gilead, both on the commercial front and with the advancement of multiple pipeline programs.

For the full year our product revenues were $5.1 billion up 36% over 2007 with non-GAAP earnings per share of $2.22, up 23% over 2007, representing Gilead's sixth year of double-digit growth for both product revenues and non-GAAP EPS. As Kevin will describe later in the call, our HIV franchise continued its momentum in gaining market share across all our commercial markets and with Truvada we have Gilead's first $2 billion product.

There were two key developments in the fourth quarter 2008 that we believe will help support continued growth of this franchise in 2009 and beyond. First, in November the US Department of Health and Human Services issued revised HIV treatment guidelines that now recommend only Truvada, also as a component of Atripla, as the backbone of choice in naive patients.

As part of this revision GlaxoSmithKline's Epzicom was downgraded to an alternative option as a result of the emerging datasets on Epzicom use, illustrating increased cardiovascular risk and rates of virologic failure in patients with higher viral loads. As Sustiva's one of the preferred third-agents, the combined product of Truvada plus Sustiva, namely Atripla, provides a patient's complete regimen in one pill, once a day tablet.

Second, at the AECA conference held in Washington DC in October, data was presented from the accord study, a retrospective analysis of more than 8,000 patients, showing that those who deferred therapy to when their CD4 count fell below 350, had a 70% increased risk of death, compared to those who started antiretroviral therapy, when their CD4 cell counts were between 350 and 500.

We think this data should and will have a further impact on treatment guidelines regarding when to start therapy. Similar to our commitment to understand the profile of our HIV and HBV products as chronic therapies, we are continuing to support Letairis for the treatment of pulmonary arterial hypertension with long-term studies.

Last fall, we presented the two-year safety and efficacy data on Letairis, the first two-year data for any endothelin receptor antagonist, at the Chest conference in Philadelphia. This data clearly demonstrated that the benefit seen at one-year, in the six-minute walk distance, is maintained through year two with both commercially available doses of Letairis.

Over the course of 2008 we received approval for, and launched for, Viread for Hepatitis B in the US, Canada, Turkey and 12 countries of the European Union. This is a highly under served market with only 3% of those chronically infected in the US currently receiving treatment.

With the profile of Viread, we believe we have the drug to dramatically change the way this disease is treated. At the AASLD conference in November of last year, we presented impressive two-year data from both our pivotal studies including data showing a 6% “s” antigen loss, a marker of complete disease cure.

We intend to continue to follow patients for eight years to further define the long-term efficacy, safety and resistance profile for Viread for hepatitis B. Gilead has now launched seven products in the last seven years, a significant achievement for any company, but particularly the one of the relative size of Gilead. Our employee base now numbers 3,400 and our achievements as a company are a testament to the level of dedication and focus that our employees bring with them to work every day.

And remarkably, today, more than one million HIV infected individuals around the world are receiving Tenofovir in one of its three forms, Viread, Truvada or Atripla. We are very proud of this accomplishment and will strive to increase that number, both in our commercial markets and in resource-limited countries throughout the course of this year and beyond.

Our efforts to expand access to our products in the developing world and among those communities most at risk are one example of the work we do to impact public health. We will continue to evocate for policies, expand access to both care and medication and we believe we are well positioned in light of any potential changes to national healthcare policy that may emerge over the coming months and even years.

As you know, in November of last year, we filed an appeal to the FDA's complete irresponsive letter to our NDA on aztreonam lysine for cystic fibrosis. Following our face-to-face meeting with the agency in late December, we are still awaiting a response. We will update you once we have received that notification.

As we look to the future growth drivers of the company beyond our commercial products, I am pleased with our pipeline progress across all our therapeutic areas, particularly our promising HIV product candidates: Elvitegravir, GS9350, and to integrate the fixed dose regimen, as well as, starting symptom for resistant hypertension and GS9190 and GS9450 for hepatitis C.

We continue to keep the hurdle bar for our research and development programs high, only bringing forward molecules that have the potential to become best in class compounds in areas of significant unmet medical need.

Next, Robin will review the financial highlights for the quarter.

Robin Washington

Thank you, John. As you have all seen in the press release we just issued, the fourth quarter was another very successful quarter and completes another record year for Gilead. Total revenues which include product sales and royalty, contract and other revenues for the fourth quarter of 2008 were $1.43 billion.

For the full year, total revenues were $5.3 billion, up 26% over 2007, driven primarily by continued strong growth in our antiviral franchise. Operating expenses were $396 million for the fourth quarter of 2008, an 8% increase year-over-year. For 2008, operating expenses were $1.5 billion which represents an increase of 18% over 2007. This increase reflects our commitment to investing in our pipeline and infrastructure to support our continued growth.

Our fourth quarter of 2008 net income was $568 million or $0.60 per share on a fully diluted basis. For the full year, our 2008 net income was $2 billion or $2.10 per share on a fully diluted basis. Non-GAAP net income per share for the fourth quarter 2008, which excludes the impact of after-tax, stock-based compensation expense was $0.63 per share on a fully diluted basis, a 44% increase over the fourth quarter 2007 non-GAAP net income of $0.44 per share.

For the full year, non-GAAP net income per share which excludes the impact of after-tax stock-based compensation expense and purchased in-process R&D expense was $2.22 per share on a fully diluted basis, a 23% increase over 2007 non-GAAP net income up $1.81 per share. In the fourth quarter of 2008 we generated $646 million in operating cash flow bringing the full year operating cash flow to $2.2 billion.

Our fourth quarter 2008 product sales were $1.39 billion marking our fifth consecutive quarter of surpassing $1 billion in total product sales and five consecutive years of quarterly product sales growth. Antiviral product sales grew to $1.3 billion for the fourth quarter of 2008 from $941 million in the fourth quarter of 2007, up 35% year-over-year and 3% sequentially.

Truvada sales contributed $562 million or 44% to our fourth quarter of 2008 antiviral product sale, up 25% year-over-year and 2% sequentially due primarily to sales volume growth. Sequentially, the increase was partially offset by an unfavorable foreign currency exchange impact.

Atripla contributed $466 million or 37% to our fourth quarter of 2008 antiviral product sales. Atripla sales increased 79% year-over-year and increased 9% sequentially, resulting from the continued uptake for this product in the US and Europe. Efavirenz portion of Atripla which is purchased from BMS at estimated market price, and reflected in cost of goods sold, was approximately $170 million.

Viread sales were $162 million for the fourth quarter of 2008, representing a year-over-year increase of 9% and a sequential increase of 4%. Hepsera generated sales of $76 million in the fourth quarter of 2008, a decrease of 1% on a year-over-year basis and 16% sequentially.

Sales of AmBisome were $76 million for the fourth quarter of 2008, a year-over-year increase of 12% and 4% sequentially, primarily driven by sales volume growth in certain European countries and the United States. Finally, Letairis sales were $36 million for the fourth quarter of 2008, a twofold increase year-over-year and an increase of 14% on a sequential basis, primarily driven by sales volume growth.

Our royalty contract and other revenues for the fourth quarter of 2008 decreased by 41% year-over-year and increased 23% sequentially. The decrease year-over-year was due primarily to the decrease in royalty revenues recognized from Tamiflu sales related to pandemic planning initiatives worldwide. The sequential increase in royalty contract and other revenues was primarily due to seasonality in Tamiflu sales.

Royalties received from Roche, and recognized in our revenues in the fourth quarter of 2008, were $16 million. These royalties which are paid one quarter in arrears reflect a royalty rate of approximately 17% as applied to Roche's net sales of Tamiflu during its third quarter of 2008.

Turning to product gross margin. As a reminder, my discussions of all margin and expense-related items are on a non-GAAP basis which excludes the effect of stock-based compensation expense. Non-GAAP product gross margin was 77.4% compared to non-GAAP product gross margin of 79.3% for the same quarter of last year and 78.1% for the third quarter of 2008.

The decrease from the fourth quarter of 2007 was due primarily to the higher proportion of Atripla sales in the fourth quarter of 2008 which include the Efavirenz component at zero gross margin. The decrease from the third quarter of 2008 was due primarily to a change in our geographic and product sales mix including a higher proportion of Atripla sales.

Non-GAAP operating margin was 52.5% for the fourth quarter of 2008 compared to 50.1% for the same quarter last year and 53.6% for the third quarter of 2008. The increase in non-GAAP operating margin compared to the fourth quarter of 2007 was primarily as a result to the fourth quarter of 2007 was primarily as a result of our strong revenue growth.

The decrease in non-GAAP operating margin compared to the third quarter of 2008 was due primarily to a decrease in our non-GAAP product gross margin related to the change in our sales mix in geography and products, as well as higher operating expenses in the fourth of 2008.

As you are aware, our non-GAAP operating margin is impacted by the Efavirenz components of a growing Atripla revenue stream and a declining trend for Tamiflu royalties. Excluding these factors, our core non-GAAP margin continued to improve, as we have been profitably managing the growth of our business.

Non-GAAP R&D expenses were $185 million for the fourth quarter of 2008, an increase of 10% on a year-over-year basis and 9% sequentially, primarily as a result of increased clinical study activity, as well as higher headcount driven by the growth in our business. The increase in R&D expenses for the fourth quarter of 2008, compared to the fourth quarter of 2007, was partially offset by a net decrease in payments incurred related to our collaboration.

Non-GAAP SG&A expenses were $175 million for the fourth quarter of 2008, an increase of 6% year-over-year due primarily to increased compensation and benefits from higher headcount as well as infrastructure and technology-related costs to support the continued growth in our business.

On a sequential basis, non-GAAP SG&A expenses increased 4% primarily reflecting slightly higher technology-related costs. Foreign currency exchange had a net favorable impact of $5 million and $13 million on our fourth quarter of 2008 revenues and pre-tax operating earnings respectively when compared to the same period last year.

On a sequential basis, the foreign currency exchange impact on our fourth quarter 2008 revenues and pre-tax earnings was an unfavorable $44 million and $18 million respectively, reflecting the unprecedented volatility in foreign currency exchange rates. Our effective tax rate for the full year of 2008 was 26.5%, which compares favorably to the 2007 effective tax rate of 28.9%.

Our effective tax rate for the fourth quarter of 2008 was 22.1%. These decreases were driven primarily by various fourth quarter 2008 items, including the resolution of a certain audit for taxing authorities, resulting in an $18 million reserve release and the extension of the federal R&D tax credits, resulting in a tax benefit of $15 million. The income tax adjustments recorded in the fourth quarter of 2008 had the effect of increasing GAAP and non-GAAP earnings by $0.04 per diluted share.

Next I would like to turn to our cash position and our operating cash flow performance for the quarter. Our balance sheet continues to be strong with cash, cash equivalents and marketable securities of $3.2 billion, as of December 31st, 2008, an increase of $517 million, when compared to our $2.7 billion balance at December 31st, 2007.

In the fourth quarter of 2008, we generated $646 million in operating cash flow, and we purchased approximately 15 million shares of our common stock, through a $750 million accelerated share repurchase transaction, which we entered into in October. In 2008 we spent $2 billion to retire approximately 39 million shares of our common stock, under the $3 billion share repurchase program authorized by the Board of Directors in October, 2007.

As of December 31st, 2008, we had just under $1 billion remaining for share repurchases under this program, which expires at the end of 2010. We continue to be committed to reviewing opportunities to leverage our cash position to return value to shareholders as appropriate.

Now I would like to turn to our financial guidance for the full year 2009. You can locate all of our guidance for the 2009 on Gilead's corporate website. Our net product revenue guidance for the full year 2009 is a range of $5.9 billion to $6 billion which reflects a 16% to 18% increase over 2008 product revenues.

The current macroeconomic environment could affect our ability to achieve this range, as there are many factors outside of our control that may have an impact on our business. These include, but are not limited to, the potential for volatility in foreign exchange rates, US and international government pricing pressures and changes in the financial health and/or practices of our business partners and our customers.

Our non-GAAP product gross margin and operating expense guidance, excludes the impact of stock-based compensation expense. Non-GAAP product gross margin guidance for 2009 is a range of 76% to 78%. We expect non-GAAP R&D expenses to be in the range of $800 to $820 million. We expect non-GAAP SG&A expenses to be in the range of $720 to $740 million, which is essentially flat, when compared to our 2008 guidance.

As, you know, we expanded the organization and increased our geographic footprint significantly in 2008. We believe we now have the infrastructure in place to support the business through 2009. As always, Gilead remains committed to conscientious expense management to sustain the continued profitable growth of our company. Our effective tax rate guidance for the full year 2009 is expected to be in the range of 26% to 27%.

Regarding after-tax stock-based compensation expense, we anticipate the 2009 fully diluted EPS impact to in the range of $0.14 to $0.16 per share. Effective January 1st, 2009, Gilead adopted FSP APB 14-1 which impacts accounting of convertible debt instruments, similar to our convertible senior notes.

This accounting pronouncement will require us to bifurcate the conversion option embedded in our convertible note and to record this conversion option in equity. The bifurcation of the conversion option will then create a debt discount on the convertible notes, which we will amortize for interest expense over the terms of the 2011 and 2013 convertible notes.

As a result of this adoption, we will record additional interest expense of $14 million and $56 million for the first quarter and full year of 2009 respectively. This will have the effect of reducing our GAAP and non-GAAP EPS by approximately $0.01 and $0.04 per diluted share for the first quarter and full year of 2009 respectively.

Since FSP APB 14-1 requires retrospective application, prior periods will also reflect additional interest expense. This retrospective application will cause both our historical gap and non-GAAP net income and EPS to be restated. Our website will include a slide summarizing the impact of FSP APB 14-1 posted along with our 2009 guidance.

In concluding, our solid operating performance continues to be a validation of the significant effort made by Gilead's employees to improve the lives of patients around the world. At this point, I would like to turn the call over to Kevin, who will discuss our commercial highlights for the quarter.

Kevin Young

Thank you, Robin. 2008 was a busy year for Gilead's commercial operations. The continued rollout of Atripla in the European Union, the growth of Atripla and Truvada in the US and Canada, the launch of Viread for HBV in the EU and the US, gains made in the PAH market for Letairis, as well as the startup of new country offices, all pave the way for what should be a very exciting 2009.

Before turning to our performance for the quarter, I would like to remind you that the analysis of market share in the US and Europe, we rely on the most up-to-date third-party data available to us in each market. Since the dates of these data points can fluctuate, we will identify the reference time periods as appropriate.

I'd like to begin by discussing the performance of our antiviral franchise. During the fourth quarter, US HIV revenues performed strongly, led by Atripla at $352 million, up 36% year-over-year and Truvada at $255 million, up 21% year-over-year. The growth of Truvada alongside Atripla is particularly gratifying and demonstrates the complementary roles of both drugs.

Sequentially, US sales of Atripla were up 2% and Truvada were down 3% quarter-over-quarter. While demand was strong, both at the retail and non-retail level for both products, this demand was not fully reflected in our revenues for the fourth quarter. We believe this is because during the quarter inventories were drawn down within the distribution channel.

In the third quarter of 2008, the number of patients being treated with antiretroviral therapy grew by 9% over the third quarter of 2007 to approximately 560,000 patients. Truvada maintained its position as the backbone of choice for antiviral therapy in the US with 188,000 patients on therapy or approximately 34% of all treated patients.

Atripla remained the most prescribed regimen in HIV with 31% of patients. This is the first time that any regimen has equaled or exceeded 30% share of treated patients. Atripla together with Truvada continue to account for greater than four out of five treatment-naive patients.

Atripla once again was used in approximately 50% of treatment-naive patients, consistent with the third quarter, in the fourth quarter we continue to see strong prescription increases for both Atripla and Truvada which grew 6% and 4% respectively.

The solid performance we saw in our US HIV marketing in 2008 should continue into 2009 driven by testing and screening initiatives as well as publications of data on when to start antiretroviral therapy. We also believe we will continue to see positive reaction to the recent changes in the DHHS treatment guidelines as well as a series of important data presentations at a medical meeting early next month. This will be expanded upon by John Milligan in a moment.

Now, turning to our HIV performance in Europe. Comparable to the US, the big five countries in Europe, continue to demonstrate robust growth. At the end of the third quarter 2008, 270,000 patients were being treated with antiretrovirals representing a 7% year-over-year growth rate.

We are very pleased with the performance of all our HIV products in Europe where Atripla contributed $103 million in European product sales and is now available in 14 countries throughout the EU, including four of the big five countries. We remain in reimbursement discussions with France, but we are encouraged with the progress made and believe we could complete these negotiations and launch the product before the middle of the year

Of the patients receiving Atripla in the fourth quarter, approximately 36% converted from Truvada plus Sustiva, while 29% were switched from other regimens. 35% of patients starting Atripla were treatment-naive patients.

And Truvada continued to build on a solid base throughout the EU and remained the No. 1 brand in all big five markets. During the fourth quarter of 2008, Truvada contributed $270 million in revenues, up 28% from the same period in 2007.

Atripla together with Truvada or total Truvada increased its share to over 70% of treatment-naïve patients, while Kivexa shares dropped to 14% at the end of the fourth quarter, down from 16%. Total Truvada achieved new highs in the NRTI market outperforming Kivexa with a prescription ratio of 2.7:1 in October, 2008, up from 2.2:1 in October 2007.

Turning to our hepatitis franchise. Since receiving European marketing approval for Viread in HBV, by the end of 2008 we have launched Viread in 14 countries. While it remains early on in the launch, we are very pleased with the feedback we have been receiving on the clinical, safety and cost benefit profile of Viread.

In Germany and the UK, the first countries where Viread was launched, at the end of October, or just six months on the market, Viread had already achieved approximately 14% and 10% market share respectively.

Since the US launch of Viread in August of 2008, our hepatitis sales and medical affairs teams have concentrated solely on Viread. We believe we have already made tremendous inroads into HBV market. Using a proprietary method of analysis, we believe Viread is currently capturing 20% of new prescriptions share of the HBV market, already surpassing Epivir and Tyzeka.

Importantly, total new prescription share for Gilead's HBV products, Viread, Hepsera has increased from 43% to 48% since the launch of Viread. During 2009, we will be supporting Viread with a broad platform of educational activities concentrated in the Asian American communities highlighting the need to screen, diagnose and link patients to care.

Now, turning to our cardiovascular franchise and Letairis for the treatment of PAH. Consistent with prior quarters, we conducted our proprietary PAH survey. According to our latest data, as we exited the fourth, approximately 32% of those patients receiving an ERA were taking Letairis, up from 28% the previous quarter. Of all patients taking Letairis, approximately 30% have switched from [placenta].

In April, we initiated our first planned Phase IV study with Letairis, and we now have an additional 17 investigator initiated studies underway. These efforts will continue to build our presence within the PAH community.

As referred to by John Martin, there has been a very positive reception in medical education forums to the ARIES-E two year data, which endorsed the profound durability of treatment response to Letairis. In closing, 2008 was filled with achievements and new commercial milestones. The opportunities for growth in 2009 look equally attractive.

I will now turn the call over to Norbert who will discuss our research and development progress. Norbert?

Norbert Bischofberger

Thank you, Kevin. As John Martin stated earlier, we have advanced a number of our development programs in 2008, and have now more projects in our research and development pipeline than ever in the history of Gilead. As we do each year, we have completed a thorough portfolio review late last year, in which we carefully considered the profile of each of our compounds, the manufacturing requirements, the market opportunity and the cost to bring them to market.

As a result, we did make a no-go decision related to GF-9131 nucleotide pro drug, which had recently completed a Phase I/II study. We instead, have opted to concentrate our HIV development efforts on our integrase and PK booster programs.

Recently we have received very positive feedback from FDA about our development plans for Elvitegravir, our once daily integrase inhibitor for GS-9350, our PK enhancer, and for our fixed dose regimen for Elvitegravir GS-9350 and Truvada. In short, FDA has agreed with our proposed simultaneous development of these three product candidates, which would then allow us to support three separate marketing obligations with four Phase III studies.

This includes the following. First, Elvitegravir as a standalone agent for use in treatment experienced patients will be supported by one Phase III study. As you know, in August of last year, we began enrolling patients in our Phase III study, study 144, which is a pivotal non-inferiority study evaluating Elvitegravir versus Raltegravir in treatment-experienced patients, and this study is more than 40% enrolled.

We had originally planned to conduct a second study in Europe, study 145, which would mirror the 144 study. But we proposed and the FDA has agreed that we can hold these two studies together; cutting the total number of patients we will need to enroll from 1,400 to 700. We're in the process of doing that now.

Secondly, the use of our integrase fixed-dose regimen in treating naive patients will be supported by Phase III non-inferiority studies, each with about 600 patients comparing our integrase fixed-dose regimen to a standard of care like Atripla or against a PI-containing regimen.

Before initiating the Phase III studies, we will conduct a Phase II study comparing the integrase fixed-dose regimen to Atripla. We have not yet received final sign-off on the study design from FDA, so, we will update you as soon as we have further clarity. The treatment community is very excited about this study and we believe it should enroll quite quickly.

Third, the NDA for GS-9350 will be supported by one Phase III non-inferiority study with about 600 patients comparing GS-9350 to Raltegravir, both in combination with a commercially available protease and Truvada. Preceding this Phase III study will be a smaller Phase II study of similar design, which we're targeting to initiate in the second quarter of this year as well.

We are very pleased with the progress of this program and look forward to sharing with you the data from both the GS-9350 and the integrase fixed dose regimen PK studies in healthy volunteers at scientific conferences later this quarter.

On the HCV front, which as you know represents our most focused research effort here at Gilead, we have begun enrolling patients GS-9190 Phase II study. This is a randomized, double-blind placebo control study comparing 24 or 48 weeks of GS-9190 dosed at 40-milligram BID, in combination with peginterferon/ribovarin to a standard of care of 48 weeks peginterferon/ribovarin in patients with type genotype 1, chronic HCV infection.

Target enrollment is 200 and, to date, we're approximately 38% enrolled. The co-primary objectives of this study are to compare the early and sustained biological response rates of GS-9190 versus placebo. With regards to GS-9450, the caspase inhibitors, in license from LG Life Sciences last year, we have recently completed a Phase IIA study in HCV infected individuals, evaluating the drug's ability to reduce serum markers of liver inflammation.

Based on these results, we're preparing to initiate the Phase IIB study in the second quarter of this year to evaluate the long-term safety and ability of 9150 to improve liver inflammation and/or fibrosis as assessed histology. We're also evaluating 9450 on the Phase II study in patients with Nash or non-alcoholic steatohepatitis.

We are currently enrolling patients in this study with a target of 110 in total, to assess the safety of 9450 and its ability to reduce serum measures of liver inflammation. We believe we can complete enrollment and have data available from this study towards the end of this year.

Other HCV research efforts, either in-house or through our collaborations with companies, such as Achillion, are focused on seven different approaches, including viral and cellular targets. Our research has led to the discovery of some very interesting lead compounds and we look forward to sharing more information, as these compounds pass certain clinical hurdles, possibly later this year.

On the respiratory front, in addition to cystic fibrosis, we have begun enrolling patients with non-CF bronchiectasis, in a Phase II study evaluating the safety and efficacy of aztreonam lysine for this indication. We're targeting completing enrollment in the second quarter and presenting data from this study before the end of this year.

The Phase III study for Letairis and idiopathic pulmonary fibrosis called ARTEMIS began screening patients at the end of last year. And as our partner Parion, announced in December of last year, a Phase I study has begun evaluating the safety and tolerability of GS-9411 an epithelial sodium channel blocker in healthy volunteers. GS-9411 is designed to increase airway hydration for the treatment of pulmonary disease.

And finally, on the cardiovascular front. We have completed the enrollment in the first Phase III study DAR 311 for Darusentan in resistant hypertension, and we anticipate having topline data from this study in the second quarter of 2009.

The DAR 312 study which is the larger of the two studies targeted at enrolling 770 patients is now 71% enrolled. We believe we're on track to complete enrollment in this study before the end of 2009, with data available likely in the early part of next year.

We're also preparing to initiate a Phase III study of Letairis in patients with pulmonary hypertension in IPF in the second quarter of this year.

We're also very close to initiating Phase II testing of cicletanine, the product we purchased from Navitas in May of last year, in 160 patients with PAH. Patients will be randomized across three doses of cicletanine or placebo. The primary endpoint will be the change in six minute walk distance, following 12-weeks of treatment.

In summary, we have made significant progress with our R&D pipeline during the fourth quarter of 2008. As we enter 2009 we have multiple product candidates, either in or about to enter, Phase III and Phase II studies, resulting in a pipeline that is more extensive today, than at any time in our 20 year history.

With that, I will now turn the call over to John Milligan for closing remarks. John?

John Milligan

Thank you, Norbert. In summary, I'm very pleased with our continued high-level of productivity and consistent financial performance in 2008. We have numerous potential catalysts on the horizon for further growth of our franchises, specifically the presentation of important datasets at upcoming medical conferences, the continued impact of guideline changes in the US and abroad, and expanding pipeline of promising product candidates and a very strong balance sheet.

We are very much looking forward to the upcoming conference on retroviruses and opportunistic infections or CROI conference, which will be taking place in Montreal, in early February. This meeting is considered to be the preeminent conference, focused solely on HIV and Aids, and brings together, domestic and international thought leaders, guideline committee members, researchers and caregivers, whose practices are dedicated to treating patients living with HIV.

We anticipate the presentation of numerous important datasets, both from Gilead's internal programs as well as from external groups. We will also be closely monitoring legislation at the state and national level to support HIV testing initiatives, bringing more patients into care and on to therapy.

Importantly, the Ryan White Program is due to be reauthorized this fall. The Ryan White CARE Act is designed to address the health needs of individuals with HIV, who do not have sufficient health coverage and authorizes funding for HIV medical and care services, including the AIDS Drug Assistance Program or ADAP. We believe that for the first time there may be additional fund earmarked specifically for testing initiatives.

In 2006, when the CDC released their revised recommendations on routine HIV screening, 30 states had no legislative barriers inhibiting routine testing. In the last two years, 11 of the other 20 states have reduced barriers to testing.

The new HIV Testing Laws in California are often cited, as a model for states to effectively encourage routine opt-out HIV testing and secure reimbursement for these tests. In 2009, additional states including New York, Massachusetts, and Texas are expected to consider legislation to further expand routine HIV testing.

As we recognized that we are in a period of economic uncertainty, Gilead remains committed to ensuring that patients who are currently on or could benefit from our therapies have access to these life saving medicines, even those who have no coverage, who lose their insurance or need assistance while trying to secure coverage. We will aim to provide the support necessary for these patients through our access programs.

In summary, as we enter 2009, the hard work and diligent focus we have maintained at our core for so many years has positioned us extremely well for the future growth of the company. We concluded 2008 with more than $5 billion in product revenues, including two products with sales more than $1.5 billion each, and over $3 billion in cash.

We have a broad and deep pipeline of product candidates for our future and we continue to focus on making a difference in the lives of the many patients around the world.

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

Question-and-Answer Session

Operator

Thank you.

(Operator Instructions).

And our first question comes from the line of Mark Schoenebaum with Deutsche Bank. Go ahead.

Mark Schoenebaum - Deutsche Bank

Okay, great. Thanks for taking my question, I appreciate it. I'm torn. I don't know what to ask. I have several questions. I'm sure the other analyst will ask some of my other ones. It was good news on the Quad, it sounded like some real progress with FDA, Norbert; and I was wondering maybe, if you could outline to us, as I was a little confused: Has the FDA already said you'll be able to start a naive Phase III after the Phase II, and can you maybe clarify that? And what do you actually have to show in the Phase II in order to start the Phase III, and do you have to wait for the Phase II to be entirely done before you go into Phase III? Thank you.

Norbert Bischofberger

Yes, Mark. Thanks for the question. We have broadly outlined to the FDA the development program, and as I said, we have three new chemical entities waiting that we could potentially get approved pretty much at the same time supported by four Phase III studies. So, with regards to a specific question, both the regulatory agencies, and also, I think, the medical community, would feel somewhat uncomfortable for us to jump directly into a Phase III study. So, what we have to do is essentially a smaller version of a Phase III which you can call a Phase II for lack of a better word, and just get some experience on limited data on safety and efficacy of the Quad in 50 to 100 patients. And once we have 50 to 100 patients, maybe for 16 weeks or so, so that would be the time when people would feel comfortable to go into a much broader, larger patient population into Phase III.

Mark Schoenebaum - Deutsche Bank

Naive?

Norbert Bischofberger

Did I say treatment experience patients? Yes, this is in treatment-naive patients.

Mark Schoenebaum - Deutsche Bank

Thank you very much.

Operator

Our next question comes from the line of David Risinger with Bank of America. Go ahead.

David Risinger - Bank of America

Yes. Thanks very much. Just to follow up on that question, could you just explain how you determine the right number of patients to ensure that the data that you receive is compelling, i.e., you know, it seemed to me, that 50 patients might be a little bit small, might entail some risk, and given the value of this program to your market capitalization, you obviously have to ensure success. So, can you speak to, you know, how many patients are really appropriate, and then, separately, could you talk about appropriate, about development timelines, ex-US, whether you can do the adaptive Phase II, III program in Europe? And how we should think about timelines ex-US? Thank you.

Mark Schoenebaum - Deutsche Bank

Yes. So, David, you are technically correct, that is a new chemical entity, but you have to keep in mind that we have actually a fair amount of data on the efficacy and safety of Elvitegravir when given with a booster of protease inhibitors. We have an extensive Phase II study where patients are now entering their year of exposure, and also, as I indicated in my talk, we have initiated a Phase III study of Elvitegravir.

So, really, the safety and efficacy of that particular compound is very much supported in the treatment experience patients. So, I think we and FDA has agreed to this, we would feel comfortable in a much smaller number, maybe 50 exposed for 12 weeks just to make sure there's nothing untoward going on.

With regards to Europe, we have to have conversations with different European regulatory agencies yet. We haven't had that yet. That's on the agenda in the first quarter. But, I am convinced we could do an adaptive trial design, and the reason is simply, you know, that the Phase II study is essentially identical to the Phase III study. The only difference is the number of patients, but it's the same in inclusion, exclusion and endpoints.

And regarding the timelines in the EU, as you may know, it's a little bit complicated because, in the EU, regulatory agencies have been talking about the requirement for two year, 96-weeks data for treatment of naïve patients. Up until now, I've only heard them talk about it, there's nothing in the regulations, but it may be that by the time we file for approval there may be that requirement, I don't know. In the US, the requirement is still 48-weeks.

David Risinger - Banc of America

Thank you.

Norbert Bischofberger

I hope that answers your question.

Operator

Our next question comes from the line of Thomas Wei with Piper Jaffray. Go ahead.

Thomas Wei - Piper Jaffray

Thanks very much for taking my question. I had a financial question on the guidance for your total product sales that is quite a bit less than what the street consensus is right now for 2009. And actually implies a much slower rate of sequential growth than you saw all the way through 2008, despite all of these new positive growth factors that you outlined.

When you look at all of our models, what do you think we need to reevaluate in our assumptions? Is it a particular product? Is it a factor like FX? Is it a mix of everything? Some guidance there might be helpful. Thanks.

Kevin Young

Hi, Thomas, it's Kevin. Let me deal with the US situation right up front. As you saw, there's been very healthy underlying growth in prescriptions. We've seen the same trends that you have seen and yet we had a relatively flat picture Q4 over Q3. To try to give you an insight into that, it does seem that our wholesaler days on hand have come down slightly.

But more than that, it seems that absolute inventory right throughout our channels, so, from the wholesalers down to the large retail chains, came down quite a lot Q4 on Q3. So, this is a situation that we're looking at very, very closely. We're not sure whether it's a temporary effect or it's something that is more permanent, because of the economic climate, and Robin did allude to that, as she talked about our guidance. I think it is important to say that the underlying trends are very strong.

The prescriptions, the syndicated patient data look very good and, of course, over and above that and as John alluded to, the guideline situations also look very much in favor. And we have just received our total non-retail data for the fourth quarter and likewise that looks also very good. So I think this is not so much a Gilead effect, there was, perhaps, some macroeconomics going on here.

Robin Washington

Thomas, this is Robin. I'll also add to that, again, as we saw from Q3 to Q4, pretty extensive FX volatility. So we have factored some of that into our model as well, as mentioned in the guidance section.

Operator

Our next question comes from the line of Geoffrey Meacham with JPMorgan. Go ahead.

Geoffrey Meacham - JPMorgan

Hi. Thanks for taking the question. Question for Norbert, I guess on the Booster. I'm wondering if you can talk a little bit about the size and the scope of this Phase II with the Ritonavir head-to-head and kind of design of that. What will you, in fact, be boosting right in the study?

Norbert Bischofberger

Yeah. So, Geoffrey, again this is not the study we have in detail discussed with FDA. But this is roughly what we're thinking about, the Phase II study will be very similar to the planned Phase III study, but smaller in size, again to get a little bit of experience with the efficacy and safety of the booster. And so, something we're thinking about this maybe 100 patients total, 50 randomized to Ritonavir, 50 to our booster, and both -- all the patients will take a protease inhibitor that needs boosting like, as an example, Atazanavir, where another would be the tenofovir, plus Truvada.

So you compare, so that the variable between the two arms, is one arm, will be on our booster and the other one on Ritonavir. And you would simply look at week-12 week-16 safety and efficacy and after that you would go into Phase III.

Geoffrey Meacham - JPMorgan

Just maybe as a follow-up to that. How do you guys think about the opportunity for the booster as a standalone in the HIV market?

Norbert Bischofberger

Well, the majority of protease inhibitors, in the case of rare types is used with, a booster. Over and above that, we're still doing some work on what might be if you like the standalone opportunity outside the classical use with the likes of Reyataz or with Persizta.

Geoffrey Meacham - JPMorgan

Okay. Thanks.

Operator

Our next question comes from the line of Yaron Werber with Citi.

Yaron Werber - Citi

Yeah, hi. Good afternoon, nice quarter. Well I think everybody here can say, I hope there are no quarters as this one. Quick question for you guys, about, I just am still confused, Kevin, just about the inventories. Wouldn't that be a one-time effect for them to draw down inventory? And don't you have inventory management agreements I'm just a little bit confused as to how much inventory was really drawn down and why isn't that a one time effect?

Kevin Young

Hi, Yaron. Yeah, basically we do have inventory management agreements, there was a little bit of drawn down in terms of days on hand. But bear in mind a day on hand, can also vary in terms of how much a day is worth. What we believe has happened here is that the actual off take from the wholesalers, the big three wholesalers, relative down to the large retail chains came down in the fourth quarter. And, you know, you can obviously think why that is in the new world we're kind of working in. But, that's what we believe happened. Data-on-hand can stay the same, because it is always a balance of what comes out of it versus what goes in.

The other thing I do want to say for Q1 this year is that we will have two less shipping days for Q1, and that's simply just because of the calendar affecting our normal shipping days which are Monday, Tuesday or Wednesday.

John Milligan

This is John Milligan. Just to further that a little bit more in terms of specifics. We're seeing a change in behavior both at the wholesaler, and we think at the retail level. And we don't know where the end of that change of behavior will be and what the new equilibrium will be for the world as business models change. So that just gives us another level of uncertainty into predicting how 2009 will be.

Operator

Our next question comes from the line of Michael Aberman with Credit Suisse. Go ahead.

Michael Aberman - Credit Suisse

Hey, guys. Thanks for taking the question. I maybe am a little slow but I want to go back to this Elvitegravir and booster. In your milestones for 2009, you talk about starting the Phase II, but if my calculation is correct, you need 16 week data and 50 to 100 patients, and some of these trials should be starting as early as two quarter. Might we anticipate rolling into Phase III by the end of 2009? Is that a potential goal?

Robin Washington

Michael, that's a good question. We typically don't like to give guidance on where we think we'll come out with data unless we have a sense for what our enrollment rate looks like. And I think as Norbert pointed out, these are studies certainly that we've got a lot of excitement about from the treating community. But we'll certainly give you an update as we get these studies underway and start to get a pace of enrollment rate.

Norbert Bischofberger

Another thing to keep in mind is, once the patients have reached 16 weeks you have to do a data count. You have to collect at least minimum CRFs and labs, and look at the two arms. So, that will take a little bit of time. It's not going to be, you know, years but its going to take a few months to do that.

Michael Aberman - Credit Suisse

Okay. But the way we're thinking about it, end of the year, early 2010, is it not unreasonable thought process? I'll leave it at that. Thank you.

Norbert Bischofberger

Yeah. Not unreasonable.

Operator

Our next question comes from the line of, with, Jeff Porges with Bernstein. Go ahead.

Jeff Porges - Bernstein

Thanks very much. I hate to push on this issue of the inventory, but could you give us an estimate of the dollar effect of what you are describing on Atripla and Truvada, because I think we're all sort of struggling with it. We're accustomed to those changes and that sort of thing, but you're obviously seeing something that's going beyond the wholesale level. Thanks.

John Milligan

Jeff, its John Milligan. The answer is: we can't. We can't give you a dollar amount. There is a lot of underlying factors that we understand very imperfectly here. So, we're unwilling to give anything out. At this time and we may not in the future either.

We get a sense that the underlying demand is reflecting the sort of growth rates in patient numbers that you've talked about earlier in the call.

Jeff Porges - Bernstein

John, could I just follow that. We get a sense that the underlying demand is reflecting the sort of growth rates in patient numbers that you've talked about earlier in the call.

John Milligan

If, by underlying demand, you meant the prescription trends, we do believe the prescription trends are accurately reflecting the growth in the overall market. It's the variances in purchases by wholesalers, and then the various things that have changed that we understand imperfectly, and that creates the variance relative to that underlying demand.

Jeff Porges - Bernstein

Okay. Thanks.

Susan Hubbard

Jeff, this is Susan. One thing I would probably just add to that. Obviously, we do have IMAs in place with our wholesalers, but we have absolutely no control at what's going on at the retail pharmacy level.

Jeff Porges - Bernstein

Yeah, of course. Thanks.

Operator

Our next question comes from the line of Maged Shenouda with UBS. Go ahead.

Susan Hubbard

Maged?

Maged Shenouda - UBS

Operator?

Operator

Maged, your line is open.

Susan Hubbard

I think we lost Maged.

Operator

Our next question comes from the line of Bill Tanner with Leerink Swann. Go ahead.

Bill Tanner - Leerink Swann

Thanks for taking the question. Just on 9350, on the booster. I know there is a lot of excitement about it, and maybe Norbert, you could help me. I struggle a little bit just in trying to figure out how broadly that could be, you know, applicable. Obviously, it would seem that that is going to interfere with metabolism of other drugs, so that someone might be taking concomitantly. They might not necessarily be an anti-viral. So, just a little clarification perhaps on that as to how you see how broadly you potentially see that being used and what kinds of obvious drugs you think it would contraindicative to use with.

Norbert Bischofberger

Yeah, Bill, something I can tell you is, a lot of the specific data will be we presented at a conference, but what I can tell you is, it's a very specific inhibitor of 3A4, CYP3A4. So, of course, it would interfere. You would expect drug interactions with all agents that are substrates for 3A4, which is quite a list, and so, it would have the same restrictions and probably the same use as Ritanovir I would imagine. You know, you could boost other protease inhibitors. You could boost non-HIV protease inhibitors. You could envision this being applied to HCV, and that contraindications or the warnings would be drug interactions.

Kevin Young

Just to add Bill, I have to say that when you look at the data, virtually all of Ritanovir today is used in the sort of HIV boosting setting.

Bill Tanner - Leerink Swann

Okay. Fair enough. Thank you.

Norbert Bischofberger

And Bill, the other thing I just want to point out, specifically the one thing we're very conscious of the 9350 we wanted to have an agent that's think that's chemically stable and that can be fairly easily co-formulated with other agents, including our own or by tenofovir Truvada. And so it doesn't needs refrigeration like Ritonavir and as such it has another advantage over it.

Bill Tanner - Leerink Swann

I mean, if I could just have one quick follow-on. So, I mean, I know initially Gilead was working on unboosted integrase inhibitor. So that programs either been abandoned understanding the competitive landscape. So I guess the company thinks that even with boosting and even with the potential that you might not have some patients be able to take it, that's a better path forward than to continue to work on an unboosted?

Norbert Bischofberger

Yeah, Bill. We had a number of very, actually two, very promising candidates that we put into human clinical development and both failed, because they were, their path life was, too short. They required three times a day dosing which I think that's not commercially of any interest. So we went with the booster a once daily of Raltegravir, now that we can co-formulated into one single pill, complete regimen, I think it's going to be a very attractive and competitive compound on the marketplace.

Bill Tanner - Leerink Swann

Okay. Thanks very much.

Operator

Our next question comes from the line of Maged Shenouda. Go ahead.

Maged Shenouda - UBS

Hi, sure. Thank you. So previously you had mentioned that, you would need the nine-month tox, monkey tox, study with 9350, before proceeding to Phase II, III. Do you still anticipate that you'll need that and do you expect that data around midyear?

Norbert Bischofberge

Yes. We still expect to meet that and the data we are currently collecting. The study is essentially done and we are, collecting the specific data of it. As you may know, a 30 day tox study, allows you only to dose in humans for 30 day. So you need a chronic tox study to be dosing beyond for 30 days, and that's what, that study, we have completed.

Maged Shenouda - UBS

Okay. And then you'll be announcing that? You'll be announcing?

Norbert Bischofberge

No, we actually never, we wouldn't announce tox results. We simply, we move forward, as long as we're confident that we have a good margin and we are confident and we'd be able to dose humans.

Maged Shenouda - UBS

Okay. Thank you.

Norbert Bischofberge

You're welcome.

Operator

Our next question comes from the line of Phil Nadeau with Cowen and Company. Go ahead.

Phil Nadeau - Cowen and Company

Good afternoon. Thanks for taking my question. It's actually a financial question on foreign exchange. I think it was mentioned a couple times that variances in the dollar is one of the uncertainties that you're working into your guidance for next year.

Could you give us some quantitative understanding of what a 5% or 10% change in the dollar would do to your topline? It seems like your hedging strategy is effective, but it's also a black box. So it's hard from quarter-to-quarter to know, exactly how much you're hedged and what a change in the currency would do?

Robin Washington

No problem. I'll be happy to give you that and we actually stepped back and look at the analysis this morning, operating income before tax basis and the range is pretty wide, because it depends on, the market-backed basket of currencies that we're hedging, which changes, as we expand [overseas] as well. But right now, it's in the range of $50 million to 100 million, and we have a 10% plus or minus change in the value of USD.

Phil Nadeau - Cowen and Company

Okay. And is that consistent for all quarters in '09 or does it vary from quarter-to-quarter because of the different contracts you have outstanding?

Robin Washington

It doesn't necessarily vary. It's kind of an overall look. We hedge 18 months out and then we kind of stagger it both percentage of the revenues that we hedge and we also take into account the offsetting natural hedges associated with the operating expenses of our subsidiary. So you have to kind of look at it on an annual basis.

Phil Nadeau - Cowen and Company

Okay. That's very helpful. Thank you.

Operator

Our next question comes from the line of Ian Somaiya with Thomas Weisel. Go ahead.

Ian Somaiya - Thomas Weisel

Thank you. Just a question on the other guidance. What factors do you assume, in terms of, I know there are no terms of guidance for HIV, but what factors should we assume as sort of potential positive drives for that franchise in '09? And obviously, we're all expecting further changes to the HIV treatment guidelines. Is that something that you have incorporated with the guidance you've given? And any thoughts on timeline for the changes there?

Kevin Young

Ian, it's Kevin. It's difficult to for us to give specifics around that, but we certainly think that's where we're going to continue to have very healthy growth of our, HIV franchise. I think we've got still plenty of growth left around the Abacavir story, particularly in Europe. Our ratio right now to Kivexa is 2.7 prescriptions to one. Here in America it's 4.9. So you can see that relative to when Kivexa was launched which was ahead in several countries in Europe, we expect to take share of that.

The expectation that there might be changing in treatment guidelines, certainly the dates are coming out around the accord data, we haven't seen the full publication on that. And that's certainly something that we can talk about in educational forums. We've got the continued rollout of Atripla in Europe for some of our big countries it will be the first full year of sales. And we are hopeful that France which is a very important market to us outside the US, we'll be able to launch the product by the middle of the year.

The one thing that could be on the downside and you never know these things, obviously is some form of economic effect on pricing. You never know what's going to happen with European governments and the way that they can sometimes come out and request price decreases.

John Milligan

Ian, this is John Milligan. I think a more specific answer to your, there is no expectation in our numbers that the US guidelines will change in 2009 because we certainly can't anticipate when those guidelines would change, and we can't model that if we don't know the timing. And we also don't know how quickly that would be adopted across the different segments of our market. So, we haven't factored that in. It's more business is normal, executing our costs plan and taking advantage of data sets that we know that are out already.

Operator

And our next question comes from the line of Steven Harr with Morgan Stanley. Go ahead.

Steven Harr - Morgan Stanley

Just a quick question. Given the long-term safety and efficacy needs that you have for Atripla, what do you think a non-inferiority trial has to show to create an actual commercial opportunity for (inaudible)?

Norbert Bischofberger

Hi, Steve. I think it would be my expectation that you could show non-inferiority, that of course, as you know, depends on the margin you chose, but if you chose a reasonable margin like 10% or 12%, but, I think the fixed-dose regimen, that includes Elvitegravir might be better tolerated for CMS, adverse events or rash, and that may also have an advantage with regards to pregnancy.

So, I think this will be a big selling point for the fixed-dose regimen containing Integrase over Atripla. And as you know, since the endpoint is proportion undetectable week 48, which is a combined efficacy safety endpoint if there were more dropouts on the Atripla due to CMS related efforts, events that could even be superior.

Steven Harr - Morgan Stanley

Operator

Our next question comes from the line of Joel Sendek with Lazard. Go ahead.

Joel Sendek - Lazard

I think you guys are ahead of the curve on patient access and you have been for years. Now, I'm just wondering if your product mix is more vulnerable to the economy than other drugs. And also, how do you account for the patient access in the P&L?

John Milligan

Joel, its John Milligan. I can't really comment as to whether we're more vulnerable than other drugs. I haven't really thought about other programs. I do know that we monitor these things very closely, and so for example, in our HIV programs, we typically transition patients over fairly quickly. ADAPs for example, capture many of these patients. So, very few come in uncovered, and we can usually put them into a program in very short order.

Our access program is terrific because patients who show up can get access to our products that day. So, if you show up, you can get Atripla on day one while you go through the process of filling out the paperwork for ADAPs drug assistance program or whatever other care you get.

The reauthorization that's coming up should help in those areas, especially to relieve some of the pressures which I think are starting to build into few of these areas of the world. The pressures are larger, for example, in our Hepatitis products and always have been. Getting patients on to coverage takes a little bit longer in those areas, so we typically have a little bit longer backlogs for Hepatitis patients, but those still seem to be flowing through as we would expect even with this economy. So, I don't know exactly if that's going to change for the future, but we haven't seen strong evidence of it so far.

Unidentified Company Representative

Yeah. Can you just talk about how we account for those charges?

Robin Washington

That would actually be for some of the access programs with some other products? It's within SG&A.

John Milligan

So it shows up as an expense.

Joel Sendek - Lazard

All right. Thanks.

Operator

Our next question comes from the line of Jason Kantor with RBC Capital Markets. Go ahead.

Jason Kantor - RBC Capital Markets

Yeah. I was going to ask about inventory, but I think you've pretty much said everything you're going to say there. But, I really wanted to find out what you think is going on with the Hepatitis B market. You say you're gaining share, but if you look at Hepsera sales sequentially and Viread sales sequentially, Hepsera is down more than Viread is up. So, how much of the Viread sales are in Hepatitis B, and is it, in fact, a growing franchise on a dollar basis for you guys right now?

Kevin Young

Hi, Jason. This is Kevin. Well, as you know, relative to HIV, we started off from a very, very small base in terms of how much of total Viread was being used in HBV. I think we're encouraged when you see the Viread usage in the HBV market. The slide is on the website. For the new prescriptions, and I think since August, to already be at a 20% new prescription share is encouraging.

Some of that has come from Hepsera. I think there's a inevitability about that because of course our 102 and 103 studies were against Hepsera, because it was the standard of care. And, you know, the results are very impressive. I think we're on a very nice curve of uptick. I think we need to obviously address Entecavir, and that's going to be I think a strong focus for us in 2009.

But, I think in the sort of four or five months that we've had it on the market, I think there's been an extremely good acceptance. Viread is now having the opportunity to transform this market.

Jason Kantor - RBC Capital Markets

But just in term of your actual sales, I mean if we exclude Ex-US, because there may be some FX issues in there. Viread is up 6 million and Hepsera is down more than 6 million. So there's actually, I mean, am I missing something in that?

John Martin

Well, you've got both, yeah, the Hepsera comes down, but you've got obviously Viread still being converted at a high-rate, you have some Viread being converted out, because of HIV conversions across to, for example Atripla. So you've obviously got a balancing act going on there and as I said, the HPV usage of Viread was very modest to the point which of we lost, the vast proportion was HIV.

Jason Kantor - RBC Capital Markets

Okay. Well, looking forward in Hepatitis B, what do you think that market opportunity is all in for the Viread, Hepsera franchise say one or two years out?

Norbert Bischofberger

Well, we don't give specific numbers on it, Jason. But, you heard from John Martin that it's a very, very low actual treatment of patients relative to the overall, infected population. It needs the right vehicle to transform that and we think Viread has got that from an efficacy and price point. I think it obviously requires Viread to do some innovative and some, very high-quality education programs, directed to the communities in which Hepatitis B lies and that's certainly on our plate for 2009.

Robin Washington

Operator, I know we're getting some static on the line. So I think probably we should take one more question and then wrap up.

Operator

Our next question comes from the line of Bret Holley with Oppenheimer. Go ahead.

Bret Holley - Oppenheimer

Yeah. Thanks for taking my question. A lot of my questions have been answered. I just wanted to ask, I guess, Kevin, how you think the two-year data for Letairis is going to play out commercially and kind of differentiating Letairis versus Tracleer?

Kevin Young

Hi, Bret. Well, first thing to say is we don't have that in promotional items, because that has not been transferred into our label as yet. So it's not used by our sales representatives. We are able to share this through educational forums, medical scientists on other programs that we do. Anecdotally, the response has been very favorable, I think its have been very much endorsed by prescribes who are seeing the efficacy themselves. But in terms of large scale promotion, we cannot do that at this point in time.

Bret Holley - Oppenheimer

Okay. Thank you.

Operator

And Ms. Hubbard, at this point, we have run out of time for additional questions. I'll turn it over to you for any closing remarks.

Robin Washington

Thank you, operator and thank you all very much for joining us today. We certainly appreciate your continuing interest in Gilead and we look forward to providing you with updates on our future progress. We'll be wrapping up shortly and I'll be available back in our office shortly for your follow-up questions. Thanks so much.

Operator

Ladies and gentlemen, thank you for your participation in today's conference. That does conclude the presentation. You may disconnect. Have a wonderful day.

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Source: Gilead Sciences Inc. Q4 2008 Earnings Call Transcript
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