Jul 19, 2007
TRANSCRIPT SPONSOR
Executives
John Milligan - COO & CFO John Martin - President & CEO Norbert Bischofberger - EVP of R&D & Chief Scientific Officer Kevin Young - EVP of Commercial Operations Matthew Howe - VP of Finance Susan Hubbard - VP of Investor Relations
Analysts
Meg Malloy - Goldman Sachs Geoffrey Porges - Sanford Bernstein Thomas Wei - Piper Jaffray Bret Holley - CIBC World Markets Jeff Meacham - JPMorgan Ian Somaiya - Thomas Weisel Partners Yaron Werber - CitiGroup Jim Birchenough - Lehman Brothers Mike King - Rodman & Renshaw Michael Aberman - Credit Suisse William Ho - Banc of America
Operator
Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences Second Quarter 2007 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, July 19th, 2007.
The speakers for today are John Milligan, Chief Operating Officer and Chief Financial Officer; John Martin, President and Chief Executive Officer, Norbert Bischofberger, Executive Vice President of Resource and Development and Chief Scientific Officer; and Kevin Young, Executive Vice President of Commercial Operations. I would now like to turn the call over to Dr.
Milligan. Please go ahead.
John Milligan
Good afternoon and welcome to Gilead's second quarter 2007 earnings conference call. We issued a press release this afternoon providing results for the second quarter ended June 30th, 2007 describing the company's quarterly highlights.
This press release is also available on our website at www.gilead.com. Also joining us on today’s call are Matt Howe, Vice President of Finance; and Susan Hubbard, Vice President and Investor Relations.
I’ll begin the call by reviewing the second quarter financial results and then I will provide updated financial guidance for 2007. John Martin, Norbert Bischofberger and Kevin Young will take you through the corporate and product-related highlights for the quarter.
We will have time at the end of this call to answer your questions. First, I’d like to remind you that we’d be making forward-looking statements related to future events, expectations, trends, objectives, and financial results that constitute forward-looking statements within the meaning of the Private Securities Act of 1995.
The statements are based on certain assumptions and 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-Q for the first quarter ended March 31st, 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 undertake no obligation to update or revise these forward-looking statements. We will be making certain references to financial measures that are on a non-GAAP basis.
We provide reconciliation between GAAP and non-GAAP on our website. Additionally, as previously announced we affected a two-for-one stock split during the second quarter of 2007 and at such all references, EPS numbers are split adjusted.
In short, the second quarter of 2007 was another very successful quarter Gilead. Total revenues for the second quarter of 2007 were just over $1 billion, driven by record quarterly product sales of $905 million, a 53% increase compared to the second quarter of 2006.
HIV product sales totaled $752 million for the second quarter of 2007, driven primarily by the continued strong uptake of ATRIPLA following its US launch in July 2006, as well as strong growth of TRUVADA in Europe. We generated approximately $512 million in operating cash flow during the second quarter of 2007.
In addition, we repurchased $455 million of our common stock from the open market, thereby completing the $1 billion share repurchase program that was authorized by our Board in 2006. Our solid operating performance continues through the validation of the significant efforts made by more than 2,700 employees of Gilead, around the world.
Each employee has played an integral part executing on the strategies implemented by the company for growing revenues and operating cash flows, including making prudent investments in both our research and development efforts and our sales and marking infrastructure. Now turning to the specific results for the second quarter.
Our second quarter 2007 net income was $408 million, up 54% compared to the second quarter of 2006. Diluted earnings per share were driven by 51% to $0.42 per share.
Non-GAAP income per share for the second quarter of 2007 excluding the impact of after tax stock-based compensation expense was $0.46 per share on a fully diluted basis, a 48% increase over the second quarter 2006 non-GAAP net income per share of $0.31 per share. Now, turning to revenue.
Total revenues for the second quarter of 2007 were just over $1 billion, an increase of 52% from total revenues of $685 million in the second quarter of 2006. This performance is driven primarily by a 53% increase in our product sales as well as 51% increase in our royalties, contract and other revenues compared to second quarter of 2006.
Product sales were a record $905 million for the second quarter of 2007, marking more than three years of consecutive quarterly product sales growth. Compared to the first quarter of 2007, total revenues for the second quarter of 2007, increased by 2%.
Product sales from the second quarter increased sequentially by 8%, as all of our product franchises continue to grow. Royalty, contracts and other revenues increased sequentially by 24%, due primarily to the seasonality of influenza and its resulting impact on Tamiflu sales and royalties, which I will discuss later.
HIV product sales grew to $762 million from the second quarter of 2007, up 60% compared to $475 million in the second quarter of 2006, and up 8% sequentially from the first quarter of 2007. TRUVADA sales were $385 million for the second quarter of 2007, up 29% compared to the second quarter of 2006 and up 11% sequentially from the first quarter of 2007.
TRUVADA sales accounted for approximately half of our HIV franchisees sales in second quarter of 2007. In the U.S., TRUVADA were $186 million for the second quarter of 2007, down 10% compared to the second quarter 2006, as certain TRUVADA patients switched over to ATRIPLA.
Compared to the first quarter 2007, U.S. sales stayed relatively flat as TRUVADA continue to hold its ways at the NRTI backbone of choice in combination with protease inhibitors.
In Europe, TRUVADA sale for the second quarter of 2007 were $173 million, almost double the TRUVADA sales for the second quarter of 2006 and an increase of 19% compared to the first quarter of 2007. Strong sales volume growth in Europe and a favorable foreign exchange impact contributed to the increase in sale.
TRUVADA sales Latin America for the second quarter of 2007 increased by $10 million when compared to both the same period last year as well as the previous quarter, primarily driven by a government tender from Mexico. In only, its fourth quarter on the U.S.
mark, ATRIPLA contributed $212 million to our second quarter HIV product sales, as demand for this product continued to rise. In its first full year on the market ATRIPLA’s accumulated over $600 million in product sales in the U.S.
VIREAD sales were $155 million for the second quarter, down 7% compared to the same period last year, and down 4% sequentially. Sales volume of VIREAD increased in both the United States and Europe during the second quarter; partially offset by a favorable foreign exchange impact for European sales.
Outside of the U.S. and Europe second quarter 2007, VIREAD sales increased by $14 million compared to same period last year and increased by $5 million sequentially due primarily to higher sales recognized in Latin America.
Hepsera for the treatment of Chronic Hepatitis B generated sales of $75 million for the second quarter of 2007, 32% increase compared to the second quarter of 2006 and 5% increase sequentially, driven by sales volume growth in both our U.S. and European markets.
And finally sales of AmBisome were $65 million for the second quarter of 2007, an increase of 16% over the same period of 2006 and an increase of 5% sequentially. This increase is primarily driven by sales volume growth in various European territories and Latin America, as well as favorable foreign exchange impact.
Compared to the same period of last year, our royalties, contracts and other revenues for the second quarter of 2007 increased by 51%. This increase was primarily driven by increased Tamiflu royalty revenues recognized from higher Tamiflu sales made by Roche in the current year as compared to the same period last year.
Royalties received from Roche in the second quarter of 2007 were $122 million. These royalties, which are made one quarter in arrears, reflect a royalty rate of approximately 17.5% as applied to Roche’s sales of Tamiflu during the first quarter of 2007.
As you may have seen Roche reported their second 2007 earnings this morning with 451 Swiss Francs or approximately $375 million reported in Tamiflu sales. We therefore expect the Tamiflu royalty revenue that we will in the third quarter will be at a rate of approximately 21% of that figure.
Turning to product gross. Product gross margin for the second quarter of 2007 was approximately 80% compared to the product gross margin of 87% for the same quarter of 2006 and 80% for the first quarter of 2007.
Compared to the second quarter of 2006 the lower gross margin is primarily due to product mix changes, especially with July 2006 launch of ATRIPLA sales, which have a lower gross margin due to Sustiva portion at zero gross margin. And turning to expenses.
Non-GAAP R&D expenses for the second quarter of 2007, which excluded stock-based compensation expense were $119 million. This is an increase of 54% from $78 million in the same period last year, and a $10 million or 9% increase from the first quarter of 2007.
Primarily as result of the increased compensation and benefits related to higher headcount, as well as increased clinical study expenses related to respiratory and cardio pulmonary program. Non-GAAP SG&A expense for the second quarter of 2007, which excluded stock-based compensation expense were $158 million.
This is an increase of 21% from $130 million in the same period last year and a $25 million or 19% increase from the first quarter of 2007, primarily as a result of increased compensation and benefits related to increased headcount and marketing and promotional expenses including those related to the launch of Letairis for pulmonary arterial hypertension which received the FDA’s approval in June of this year. The increase in non-GAAP SG&A expenses in the second quarter of 2007 compared to the first quarter of 2007 was also due to increased general corporate expenses.
In terms of the foreign exchange impact on pretax earnings, we experienced a $19 million favorable impact in the second quarter of 2007, when compared to the same period last year and a $7 million favorable impact when compared to the first quarter of 2007. This favorable impact, which was primarily due to the stronger European currencies relative to the U.S.
dollar takes into account product sales and expenses generated from outside the United States, as well as our hedging activities. Our tax rate for the second quarter of 2007 was 28.5%, a decrease from 31.4% tax rate for 2006.
The lower tax rate was primarily driven by increased earnings and lower tax jurisdiction. Additionally, our second quarter 2007 tax rate decreased sequentially from 29.9% in the first quarter of 2007, due to the finalization of certain purchase accounting adjustments related to the Corus and Myogen acquisitions.
Finally, I would like to turn to our cash position and operating cash flow to highlight our cash flow performance for the quarter. Our balance sheet at June 30, 2007 showed cash, cash equivalents and marketable securities of almost $2 billion.
This is a slight increase when compared to the balance of $1.9 billion as of March 31, 2007. The increase during the second quarter of 2007 was primarily attributable to the $512 million of operating cash flow generated during the quarter offset by our repurchase of approximately $435 million of our common stock under our stock repurchased program during the second quarter of 2007.
We continue to actively evaluate strategic ways to use our cash and investments, including potential opportunities to in-license or acquire products to complement our own internal efforts and other strategies to enhance stockholder value, including future additional share repurchase program. Now, I would like to turn to our financial guidance for the full year of 2007.
You can locate all of our guidance for the 2007 year on Gilead's corporate website. We are very pleased with the sequential quarter-over-quarter growth in our product revenue, particularly our HIV franchise.
Both AmBisome and Hepsera performed solidly in the second quarter, as well, consistent with the growth we saw in the first quarter. Therefore, we are taking this opportunity to raise our net product revenue guidance to a range of $3.6 billion to $3.7 billion, up from the $3.4 billion to $3.5 billion range we provided on our first quarter conference call.
This is for direct product sales only and does not include revenue from either royalty revenue or contract revenue. As a reminder, the expense guidance we are updating today will be non-GAAP, which excludes the impact of stock-based compensation expense.
First, we are lowering our non-GAAP R&D expense guidance from a range of $510 million to $530 million to a range of $500 million to $520 million, based in large part to the delay expenses associated with certain clinical programs, in particular the Phase 3 Darusentan study 311 which has just begun to enroll patients under the new protocol. As a reminder, this expense guidance does not include any potential new collaborations or product licensing activities.
Second, due to the impact of weaker U.S. dollar on our international operating expenses, which we do not hedge, we are raising our full year non-GAAP SG&A expense guidance to a range of $580 million to $600 million from a range of $570 million to $590 million.
Regarding stock-based compensation expense, we are reiterating the 2007 fully diluted EPS impact to be in the range of $0.13 to $0.15 per share on a split adjusted basis. We are also reiterating our gross margin guidance range of 70% to 80%.
And finally, we are lowering our tax rate guidance from a range of 30% to 31% to a range of 29% to 30%. We expect this lower tax rate as a result of higher than anticipated earnings in lower tax jurisdictions.
This concludes the earnings reporting section of the conference call. At this point, I would like to turn the call over to John Martin, who will review our corporate milestones in the second quarter of 2007.
John Martin
Thank you, John. Good afternoon, everyone, and thank you for joining us today.
We are pleased to summarize for you Gilead's many accomplishments during the second quarter of this year. I will start by reviewing our corporate milestones for the quarters, and then Norbert will provide an update on our research and development programs, and then Kevin will review our commercial efforts.
First, the FDA's approval in June of Letairis for the treatment of pulmonary arterial hypertension marks a significant milestone for Gilead. This is another example of our commitment to bring new treatment options to patients who are suffering from diseases that represent unmet medical needs, this time in the area of cardiopulmonary disease.
Importantly, this also demonstrates Gilead's ability to bring products with differentiated profiles to market, with a strong label to support them, that are outside the scope of our historical core disease focus. In a moment, Kevin will describe for you our commercial efforts and progress since the approval in June.
We also saw important progress with our other late-stage development programs during the second quarter. Both of our pivotal studies of VIREAD for Chronic Hepatitis B, and the second registrational study of Aztreonam Lysine for inhalation for the treatment of pulmonary infection associated with cystic fibrosis yielded positive results; results that will put us in the position to begin regulatory filings for these two potential products before the end of this year, with revenue stream potential as early as the second half of next year.
With regards to Tamiflu, as John Milligan mentioned earlier, Roche released their second quarter financial results earlier today and reported second quarter Tamiflu sales of 451 million Swiss francs and updated their guidance to a range of 1.2 billion to 1.4 billion Swiss francs for pandemic sales only for the full year of 2007. The incremental increases due to the fact that they are now including to guide pandemic sales in their guidance figures.
To-date, Roche has received orders for 250 million treatment courses from more than 80 countries worldwide. In the United States, specifically, they have delivered nearly 44 million Tamiflu treatment courses to the U.S.
federal government and various states. During the quarter, Roche also announced it has received U.S.
approval of two alternative doses of Tamiflu, the 30-milligram and 45-milligram doses for the treatment and the prevention of influenza in children one year and older that can now be used instead of the oral suspension formulation. An additional advantage of the newly approved capsules is that they have a five-year shelf life, compared to that of the liquid formulation which only has a one-year shelf life.
The 30-milligram and 45-milligram capsules will be available in pharmacies nationwide and for government stockpiling for the 2007-2008 flu season. And finally, I would like to give a brief update on our developing world efforts.
As you know, since 2003, Gilead has had in place the Gilead Access Program established to provide access to our antiretrovirals in the developing world. The program now includes both VIREAD and TRUVADA, making the drugs available at significantly reduced pricing in 97 resource-limited countries.
While we have made considerable progress submitting regulatory filings for the products in most of these countries, the pass to approval and distribution have been slow. In many instances, we have found it necessary to secure local agents and distribution partners and we are now nearing completion of distributor agreements for the major regions where our Access Program is operational.
We have recently seen some encouraging progress on this front. First, in March, VIREAD, TRUVADA and ATRIPLA were added to the World Health Organization revised list of essential medicines.
This is important in that many developing world governments reference this list before they review regulatory submissions for products locally. Also in April, our partner, Aspen Pharmacare of South Africa announced that they received approval from the Medicines Control Council, South Africa's regulatory body to manufacture and distribute both VIREAD and TRUVADA in South Africa.
Through a non- exclusive manufacturing and distribution agreement that Gilead entered into in 2005, they were granted the right to manufacture and distribute VIREAD and TRUVADA in all 53 African countries. While the progress on the developing world front does not represent a financial opportunity for Gilead, we are very pleased that more individuals suffering with HIV in the developing world may begin to have opportunity to benefit from our products.
I will now turn the call over to Norbert to discuss our research and development milestones for the quarter. Norbert?
Norbert Bischofberger
Thank you, John. In the second quarter of this year, Gilead achieved several significant research and development milestones, further advancing our pipeline programs.
In particular, we’ve released top line data from two of our Phase III programs, putting us on the path for regulatory findings for both products before the end of this year. The first of which is has aztreonam lysine for inhalation.
As you know, last December we reported positive top line Phase III results from AIR-CF2, the first of two clinical studies evaluating as K&M lysine for inhalation in cystic fibrosis patients with pseudo Mona’s infections. Positive data from this study were presented in April after cystic fibrosis development network conference in Seattle, Washington.
In June, we released top line data from the second pivotal phase III study, the AIR-CF1, which evaluated the safety of efficacy of aztreonam lysine for inhalation versus placebo over 28 days in patients with CF. The study met the primarily efficacy end point of change from base lien in respiratory symptoms as assist by CFQR, if patient reported outcome tool use to measure health related quality of life for patients with CF.
Data from the 164 patients double blinded, randomized study demonstrated a significant improvement using this quality of life metric, with a mean treatment difference of 9.7 points, versus placebo. FDA has a great that a five-point improvement is clinically meaningful and has set this as a threshold for a positive study.
Aztreonam lysine for inhalation treated patients also experienced significant improvement at day 28 in respiratory function as measured by FEV1 with a mean treatment related improvement of 10.3% versus placebo. We believe this is particularly impressive due to the more advanced stage of this population as compared to earlier registrational studies conducted with Tobin.
We are pleased to announce that the full study results of ARCF, one have been accepted for presentation at the NACF conference taking place if Anaheim in October of this year. With the positive results we now have in hand from both pivotal studies.
We are on track to find a new drug application in the U.S. by the end of this year.
We plan to have further discussions with European regulators to be find a path for finding them as well and will provide you with an update after we have more clarity. In the interim, before commercial availability, we recently announced that we are initiating an expanded access in the United States to make the aztreonam lysine in inhalation available to CF patients six years older or who have pseudo Mona infections.
The EAP program will initially be open for patients who have the most severe lung function impairment and we intend to expand this program subsequently in define stages to additional patient populations. The second program for which we released Phase III data is our program evaluated in alphabet DF or VIREAD for the potential treatment of chronic hepatitis b.
Study 102 is comparing the efficacy, safety and total ability of VIREAD to Hepsera over 48 weeks among patients with HBe antigen negative, anti HBe antibody positive or presumed precore mutant chronic hepatitis b. 375 patients were randomized in a two to one ratio to receive either Hepsera DF or Hepsera each given once a day.
The primary efficacy in point the proportional patient with a complete response at week 48 was defined by serum HPD and a levels below 400 copies per mill and has to watch with improvement care across by at least a two point reduction in the delanco inflammatory score with no concurrent worsening of fibrosis. That week 48%, 70.8% of the patients in the VIREAD arm had a complete response compared to 48.8% in to Hepsera, which is a highly significant difference.
The second Phase III study, study 103 is comparing the efficacy, safety and tolerability of the area to Hepsera over 48 weeks among patients with HBe and that will positive chronic Hepatitis B 266 patient were randomize in a two to one ratio to receive either VIREAD, or Hepsera both given once daily. The primary efficacy end point for this study at 103 was the same as the end point for study 102 that I have just described.
At week 48, 66.5% of patients in the VIREAD had a complete response, compared to 12.2% in the Hepsera. These results were also highly statistically significant.
We're currently in the process of putting together the filing packages for the U.S., the European Union, Switzerland, Canada, Australia and New Zealand and Turkey, which we expect to submit prior to the end of this year. We also hope to present the data set for both studies in full and medical meeting later this year.
Turning briefly to HCD. As we announced previously, our novel non-nucleoside inhibitor GS 9190 is currently in a Phase I study in Aids CMV infected patients and has demonstrated encouraging pharmacokinetic exposure and antiviral activity at the single dose.
We are now progressing to the second part of this study, which is evaluating once and twice daily doses for eight days. The study is designed to enroll 60 asymptomatic patients in total and is assessing safety tolerability pharmacokinetics and antiviral activity of GS 9190.
We anticipate completing this segment shortly and expect data from this study in the third quarter of this year. Now a brief update on the Darusentan for resistant hypertension Phase III program.
As you may know following our discussions with the FDA were in the process of implementing protocol modifications to study 311, which we anticipate was speed up enrollment and reduce overalls costs. The protocol amendment reduces the requirement for the minimum number of background intra hypertensives that a patient has to be on at the time of enrollment from four to three.
Most of our U.S. sites are now through the IAB process our enrolling patients under the revised protocol and we expect the rest of the U.S.
as well as international sites will be up and running prior to the end of the third quarter of this year. We have also begun enrolling patients in study 312, which is a larger study targeting 770 patients, and comparing Darusentan to Guanfacine or Placebo in a three to three to one randomization.
WE look forward to provide you with more specific information and when to expect data from this program as we progress in our involvement. And finally on Darusentan I pleased to say that data from Phase II study of Darusentan in resistant hypertension have been accepted for publication in the medical journal, which we expect to be publish prior to the end of this year.
Turning now to our HIV programs. Last October we along with our partners Bristol-Myers Squibb and Merck announced the submission of the ATRIPLA marketing authorization application to the EMEA and the European Union.
The main issue that were currently discussing with the European regulatory authorities relates to the method of administration of ATRIPLA, dosing with or without food. Unlike in the U.S., the current European prescribing information states that TRUVADA should be administered with food were as efavirenz administered on an empty stomach.
Our proposal is for ATRIPLA to be administered like efavirenz on an empty stomach. This is supported by clinical data and to extensive post marketing experience with ATRIPLA in the United States.
We are working to resolve this issue with European regulators to keep the approval of ATRIPLA on track for the end of this year, however, in the requirement for additional data would delay the approval of ATRIPLA into European Union. Turning now to elvitegravir or to GS 9137, as it was called previously, as you know, we presented the results from the 24 week Phase II dose-ranging study in February.
We have concluded our end of Phase II discussions with FDA and are currently considering our options for Phase III development of elvitegravir. Due to the availability of major classes of antiretroviral with demonstrative antiviral activity in treatment-experienced-patients by rather on end in particular elvitegravir both of which are available to patients currently to expanded access programs.
We plan on conducting our Phase III studies comparing elvitegravir to one of those new classes. Where are currently in the process of finalizing the protocols end up to any agreement from FDA if like this specific designs.
Once agreement is reached, and following availability of the new agents, we will initiate our studies which we hope will be later this year. In March of this year, we announced that we're moving forward with GS 9219, in novel nucleotide analog which have shown evidence of anti cancer activity in brief clinical studies.
The early data shared at AACR meeting in April in Los Angeles have formed the basis for our decision to initiate Phase I clinical studies in cancer patients, and we hope to initiate those things in our Phase I program in the third quarter of this year. Based on the outcome from those Phase I studies, we will make a decision on the development and potential commercialization path for this compound.
In summary, I'm proud of the research and development advances we have achieved over this quarter. We have many exciting opportunities to work on over the course of the coming year, and I look forward to keeping you updated on our progress.
I will now turn the call over to Kevin Young to discuss our commercial efforts. Kevin?
Kevin Young
Thank you, Norbert and good afternoon everyone. To begin, I’d like to provide a brief update on the commercial launch of Letairis, which as John Martin mentioned earlier, is and endothelin receptor antagonist or ERA, that was approved by the FDA on June 15th for the treatment of Pulmonary arterial hypertension or PAH.
Pulmonary hypertension consists of to five groups, based on the WHO classic clinical classification system. PAH is defined as WHO Group 1 of that classification system.
The PAH patients are, in turn, characterized by four functional classes. Letairis has been approved by the FDA for one steady treatment of PAH in patients with WHO functional Class II or III symptoms, which accounts for an estimated 80% of the diagnosed patient population.
While it is clearly early in the launch phase, our sales teams have been making considerable progress. Their focus has been on the large PAH centers, together with cardiologists, pulmonologists, and rheumatologists, who are either directly treating or referring PAH patients to specialists.
The feedback we have been getting is very encouraging. In the first week following the approval, I'm very pleased to be able to say we have had patients received that filled prescriptions of the Letairis through the Letairis Education and Access Program or LEAP program.
As a reminder, every PAH patient must enroll in the LEAP program before Letairis is dispensed. Our decision to crush Letairis, apparently to descend those symptom has been extremely well received.
Both doses of Letairis, 5mg and 10mg are priced the same, ensuring that cost-driven patient is not an impediment to proper dosing. We have also received a resounding vote of approval for our integrated and comprehensive package of reimbursement services, our so-called Gilead Solutions.
Physicians, we have been in contact with, have unanimously applauded the clear stance taken by us to help with patients out of profit expenses. At first, all private paid patients with PAH.
We don't anticipate any delays in getting rapid formulary approval with all private and public payers over the coming months, with a tiering at least comparable to our competition. Overall, while it is only a matter of four weeks since FDA approval, we are pleased with the initial response to Letairis.
We believe that the differentiated product label, in terms of efficacy, safety, drug interactions and dosing, together with the support services we have provided, position us to achieve our goal of becoming the ERA of choice for PAH patients. Now, turning to our U.S.
HIV franchise performance. I'm using the most up-to-date, third party patient data that are available for the first quarter of 2007.
Now, we’ve approximately 625,000 patients under care and approximately 500,000 patients being treated with antiretroviral therapy in the U.S. The population of treated patients has grown by 8% over the last 12 months.
Of the patients on antiretroviral therapy, there were well over 100,000 patients receiving ATRIPLA as of the end of the first quarter of 2007. This represented 21% of all currently treated patients in only the second full quarter sales following launch.
ATRIPLA continued to solidify its position as a number one antiretroviral regimen, with nearly three times the number of patients of the next most prescribed regimen, TRUVADA plus boosted. Nearly 50% of all treatment denied patients, are being prescribed ATRIPLA.
The uptake of ATRIPLA continues to be driven predominantly from switches, at a level of 66% during the first quarter of 2007. Importantly, 41% of these switches came from antiretroviral regimens, not containing do not appear or FTC.
This represented incremental business to Gilead, up from 29% of switches in the fourth quarter of 2006. 17% of all switches to ATRIPLA, in the first quarter of 2007, were from Combivir continuing regimens, mostly from Combivir plus Sustiva.
After eight months of launch, at the end of the first quarter of 2007, 18% of the Combivir plus Sustiva patient population have been switched to ATRIPLA, up from 14% in the prior quarter. Total TRUVADA, which is a ATRIPLA, plus TRUVADA, accounted for 80% of new starts in treatment of aids patients.
In the first quarter of 2007, approximately 310,000 or 62% of all treated patients were receiving the tenofovir molecule in one its three forms namely ATRIPLA, TRUVADA or VIREAD. Up approximately 8% from the approximately 288,000 patients receiving a tenofovir molecule in the fourth quarter of 2006.
Approximately 254,000 patients on therapy were receiving total TRUVADA in the first quarter of 2007, up 6% from approximately 240,000 patients in the fourth quarter of 2006. This is now almost three times the number of patients receiving Combivir.
TRUVADA remained a leading MRTI backbone in each of the four ARV regimens. In order ATRIPLA, TRUVADA plus Reyataz, and TRUVADA plus Sustiva.
Turning from patient data to total prescriptions, TRUVADA and ATRIPLA were the two most prescribed and NNRTI brands during the second quarter 2007. And TRUVADA and tenofovir strengthened their position after two leading molecules in HIV treatment during this period.
While the launch rate ATRIPLA has not substantially altered the ratio of NNRTI to PI use across all lines of therapy, it has changed the dynamic in patients starting therapy. Prior to the launch of ATRIPLA the NNRTI to PI ratio was 50-50.
In the first quarter 2007, approximately 60% of patients started on NNRTI therapy as about third agents, compared to approximately 40% starting on a PI. We see continued opportunities to grow our HIV franchise, not only based on the current body of data supporting ATRIPLA and TRUVADA.
But also based on overall market dynamics led by increased public awareness and focus on HIV testing, that continue to unfold in the U.S. and Europe.
June 27th was National HIV testing day. A day that marked the combination of efforts around the country, encouraging individuals to know their HIV status.
While it is difficult to know the true impact of these efforts, the National awareness that this has created is a posted catalyst for making HIV screening routine. Coinciding with National HIV testing day, the CDC published an HIV testing focused edition of its mobility and mortality weakly report, which included data from a number of important studies.
Including a study piloted in emergency rooms in New York, Los Angeles and Oakland, suggesting that expanded integration of HIV testing can successfully help identified persons with previously undiagnosed HIV infection. And may increase these individuals' linkage to health services earlier in the course of their infection.
Rod Blagojevich of Illinois marked National HIV testing day by signing into law state senate bill 929, which stream lines the process and inform consents and pretest counseling, which can often be a barrier in our administration of HIV tests. Many states are re-evaluating their informed consent laws related to HIV testing because of the CDC recommendations.
And legislation similar to that enacted in Illinois, is expected to be adopted by other states before the end of the year. We’re also encouraged by signs that European governments are seeing the need to increase the focus on HIV diagnosis and their treatment.
And later this year, and into 2008, we hope to support educational forums for National and Pan-European debate among the constituent bodies involved in the HIV tests. Finally, as you may know, the International Aids Society conference will kick off next week in Sydney, Australia.
We will be presenting 144 with data, from study 934, which has continued to confirm the long-term efficacy and safety of a regimen of TRUVADA plus Sustiva compared to Combivir to Sustiva. In addition, five year data can study 903 will also be presented at IAS.
Turning to our HIV franchise performance in Europe and utilizing the most up-to-date third party data available for this region. The total number of patients treated with anti-retroviral therapy in the big five European countries increased to approximately 243,000 in the first quarter of 2007.
An increase of 3% from the fourth quarter of 2006, and 9% year-over-year. TRUVADA continued to be the leading in NNRTI across all big five markets with approximately 30% of all treated patients in the big five receiving TRUVADA.
In the first quarter of 2007, approximately 74,000 patients were benefiting from a TRUVADA-based therapy, up 10% from the previous quarter. Patients new to a TRUVADA-based regimen were almost evenly split during the first quarter of 2007, with 52% coming from switches and 48% coming from patients new to therapy.
Patients switching to TRUVADA were largely being switched from Combivir and 3TC-based regimens. In the first quarter of 2007, TRUVADA captured 50% of all patients that switched from Combivir.
Combivir switching still represents significant opportunity with approximately 48,000 patients remaining on Combivir-based regimens in the big five EU countries as of the first quarter of 2007. Use of TRUVADA accounted for 46% of new starts in treatment-naive patients during the first quarter of 2007.
TRUVADA plus Sustiva continued to extend its leads for patients initiating therapy, growing to 23% of new patient market share during the first quarter of 2007, followed by Combivir plus Kaletra with 12%, and TRUVADA plus Kaletra with 11%. In summary, TRUVADA has performed extremely well across Europe, essentially recreating the uptick dynamics seen in the U.S.
We believe there's still growth potential in all markets for Tenofovir to become the leading NRTI molecule and for increased use of Emtricitabine Turning briefly to Hepsera. In the United States Hepsera continued to be the leading antiviral agent for the treatment of chronic hepatitis B.
in the second quarter of 2007, Hepsera continued its track record of positive quarter-on-quarter growth, in total prescriptions. Since its launch in 2002, as well as strong year-over-year growth of 8% over the second quarter of 2006.
As of the first week in July 2007, Hepsera maintained its place as market leader with total prescription market share of over 48%. Importantly, a patient new to therapy, Hepsera continues to be the therapy of choice with 42% of new patient market share.
In the Gilead territories outside the U.S., the patient opportunities for chronic hepatitis B has increased steadily. In Europe, as impacts of economic migration continues to unfold, countries like Germany have experienced an increase in their inflated population.
There are now an estimated 500,000 HPV infected people in Germany. In the European continent as a whole, approximately 9 million people are estimated to be infected with HPV with only 25% of those being diagnosed and less than 15% of the diagnosed population currently receiving treatment.
With the long-term safety, efficacy and resistance data we have generated Hepsera, we believe we are well positioned for continued international growth of our brand. Turning to anti-fungal AmBisome.
AmBisome had an excellent quarter with sales of $65 million in the second quarter of 2007, up from $62 million in the first quarter of 2007. We have seen a steady pickup in sales of AmBisome thanks to our concentrated sales and marketing effort by our European team.
Data from the Ambilobe study continues to be a great utility in reinforcing AmBisome's position as a highly effective treatment for invasive in basic fungal infections. In summary, I'm very pleased with the across-the-board performance of all of our Gilead products in all regions.
Moreover, the recent launch of Letairis has demonstrated that we now have the commercial capabilities to deliver innovative therapeutics to patients beyond our core antiviral and anti-fungal areas. I will now turn the call over to the operator to begin the question-and-answer portion of the call.
Operator?
Operator
(Operator Instructions) Your first question comes from the line of Meg Malloy with Goldman Sachs. Please proceed.
Meg Malloy - Goldman Sachs
Thanks very much, everyone. I guess two questions probably to Norbert.
One is on the ATRIPLA discussion in the EU, is it possible that you'll have to do additional clinical work to satisfy their question about the food/no food. I mean in terms of discussions with the FDA on the integrated Phase III study, can you discuss sort of the pros and the cons of the drugs in terms of hurdles and opportunities and which way are you guys leaning?
Thank you.
Norbert Bischofberger
Okay. I will take that last question first, Meg.
And also with the discussion we had and we also had with patients advocacy communities now with the availability of these new class, it's not really possible anymore to do clinical study like you used to do them. You do background, optimized background regimen, and then you add placebo or your control agent, but now it's more appropriate to do an active control study, so essentially, you would test you’re compound against one of these new classes and in the non-inferiority design.
Now with regards to which class we will prefer frontally and I think it's obvious we would prefer elvitegravir, for the simple reason that maraviroc necessitates tropism assays and you can relate Olivenol CCR5 positive patients. And so that’s get up to short of it.
So, the study we’re contemplating are one of the studies the non-inferiority study versus elvitegravir. And then make regarding you’re second study at certainly possible that clinical, more clinical data would be required for European approval, and that's the process we are currently go through that I was eluding to in my talk before.
Meg Malloy - Goldman Sachs
And can I follow-up on that? Do you have a sense of what the timing might be, or what do you need to satisfy before you can actually start the integrated study?
Norbert Bischofberger
Only get agreement with FDA on the exact protocol, and we have actually submitted, written protocols to FDA. That should be a fairly quick process, the more longer process may be and that may be a limitation, is availability of the agent.
As you know, we either have to get cooperation from the companies that they provided to us, or we simply have to wait until they are commercially available and then purchase them.
Meg Malloy - Goldman Sachs
Alright. Thanks a lot.
Norbert Bischofberger
Thanks.
Operator
Your next question comes from the line of Geoffrey Porges with Sanford Bernstein. Please proceed.
Geoffrey Porges - Sanford Bernstein
Thanks for taking the question. A question first of all on, VIREAD in HPV.
Kevin could you give us a sense of what your initial research is telling you would be amount of cannibalization you expect to have with the launch of VIREAD in that indication and sort of and give us a sense of dimensions of the market opportunity you see there. And then Norbert, could you just give us a sense of the additional indications that you are contemplating for LITARIS, where you’re thoughts are and in terms of clinical trials in those opportunities.
Thanks.
Kevin Young
Hi Geoffrey, this is Kevin. Obviously, we are still quite a long way from the launch of VIREAD in HPV, so we are fine tuning all our market research.
Our expectation is that most of the Hepsera patients who’ll likely stay on Hepsera. So, we won't be looking for significant cannibalization of the existing Hepsera patients.
We will be looking obviously for new patients or indeed for patients who might switch from other therapies. So, we don't think that there will be a wholesale switching of Hepsera, and in some ways the proxy of what we are seeing and going through HIV is not a bad one.
So, I think in both the U.S. and in Europe, we’ll be looking for the additional new patients as they flow through, and because of the encouraging early data we’ve seen in terms of profile, and certainly in Europe, a price point.
I think will be very attractive to reimbursement of payers. I think we can do very well with that patient flow.
Norbert Bischofberger
And so Geoff, regarding your second study, we are thinking really about two approaches. One is additional studies in pulmonary hypertension for Ambrisentan and just to give you a few examples.
One thing we are very interested in is using Ambrisentan in patients that have currently not optimally responding to existing therapies like PD5’s or other ERAs. Secondly, we are looking also looking at combination studies ERA’s plus Ambrisentan particularly you could think that something two agents that are both given once daily would be fairly appealing.
And the other big opportunity which is also the challenge is that ERA’s have activity and many diseases and we are currently working our way through that, looking at what is most promising from a scientific medical point of view and what is most appealing.
Geoffrey Porges - Sanford Bernstein
Okay. Thanks very much.
Operator
Your next question comes from the line of Thomas Wei with Piper Jaffray. Please proceed.
Thomas Wei - Piper Jaffray
Thanks very much. The first question was just on the U.S.
TRUVADA (ph) sales, the growth there on a sequential basis was a little bit weaker than we would have expected, and relative to the prescription data. And I just wanted to understand, there is anything else that we should be thinking about and interpreting that trend in anything on the retail, non-retail side that might have turned that number off.
And then secondly, on the EMEA request for a ATRIPLA. Can you give us a sense of where the discussions have gone there on clinical data?
What the burden of that data would be as a just simple food instruction study that you would need to do, or you’re talking about a full blown clinical study with the 24 weekend points?
John Martin
Thomas, it's John. I will answer your question to this question, the growth doesn't look to correlate with the prescriptions this quarter and we looked at the data and we saw a couple of interesting things.
One of which was, we didn't have the data in our last call, but we got it later, which was that in Q1, and in particular in March, there were the large surge in the non-retail segment that occurred mostly in March, somewhat at the end of a fiscal year for a lot of these organizations. So there was a buy-in that we weren’t aware of the, since the last time we released our figures.
And that led to, sort of what I will call, a sequential flatness in the non-retail market. It was basically flat quarter-over-quarter.
And so that's the part that you guys don’t see and we have most of the data, but not all of it yet. And it looks just like it's just flat quarter-over-quarter.
And we have seen some of this happen previously in the non-retail market, which is less predictable and that tends to have to be a little bit lumpy, right know, in the purchasing patterns of places like Florida.
Thomas Wei - Piper Jaffray
And if that’s all, then just to add to that, we have heard anecdotally that some of the states perhaps so had difficulty interpreting the reauthorization Ryan White Act and that kind of triggered their little bit of purchase in the first quarter, because that's the end of their financial year, and I think that’s what we’re worried about, use it or lose it situation.
John Martin
Mr. Thomas, regarding your second question, if you take this strict regulatory view, you could ask, is there a difference when you administer ATRIPLA without food as we proposed and as we think it’s justified versus administering the two individual agents, Sustiva and TRUVADA, Sustiva given without food and TRUVADA with food, that’s the real essence of the question that arose.
We submitted data to EMA, that we think are convincing, particularly Study 934. In Study 934, the protocol that we had was that TRUVADA and Sustiva can be given without regards to foods.
We subsequently created case report forms and asked a subset of patients how they actually took their drugs and the large majority took it at bedtime on an empty stomach. We then analyzed that population versus the other population and saw that there is no difference.
And so that's connected the nature data that we have and the argument and discussion that has gone back and forth. But again, it's an ongoing conversation and we still are hopeful that we can adequately and positively resolve it.
Thomas Wei - Piper Jaffray
Thank you. That's very helpful.
Operator
Your next question comes from the line of Bret Holley with CIBC World Markets. Please proceed.
Bret Holley - CIBC World Markets
Yeah, hi. Thanks for taking my question.
I guess just a follow-up on the last question from Thomas. I just wondering Norbert, how the discussions went in the U.S.
in the bed versus past-bed issue for ATRIPLA and why this wasn’t an issue with the U.S. regulators?
Norbert Bischofberger
Yes. So, let me quickly -- I don’t want to - I would hate to spend the whole time on this issue.
But quickly, so in 2003, so niobium, ATRIPLA and the VIREAD was approved and the method of administration was with food. We subsequently had a number studies, where we did cross study comparison and we found that giving ATRIPLA to VIREAD with a light meal was similar to giving Aspirin and only if you give it with a high fat meal, and that would lead to a full defect.
We subsequently looked at a number of our studies, figured out how and which diet actually the patients took and we came to the conclusion that it reflects more of a low fat meal than a high fat meal. And that argument -- based on that argument, we successfully changed our label in the U.S.
for VIREAD in -- I think it was early 2003. Subsequently TRUVADA was approved without food and ATRIPLA was approved to be given on an empty stomach at bedtime.
And that argument never -- we were not successful in the European Union, simply because they were insistent on very controlled side-by-side studies and that's not something that we had at that time. It weren’t really continuing.
Bret Holley - CIBC World Markets
Okay. Thank you.
Norbert Bischofberger
Welcome.
Operator
Your next question comes from the line of Jeff Meacham with JPMorgan. Please proceed.
Jeff Meacham - JPMorgan
A quick question for you on ATRIPLA. Were there any inventory draw-downs in the quarter and then was the rate of switches from TRUVADA to ATRIPLA different in this quarter versus prior periods?
And I have a question second follow-up on the Letairis.
Norbert Bischofberger
Quickly on the inventory. There were -- so if you look across the inventory of all of our products, we continued to range mostly in the midrange for all of our products.
ATRIPLA kind of ended up just slightly, but it's at the very low end of the range that we, as you recall in Q1 -- actually Q4 and Q3 last year, we were behind the curve. We’ve kept up a little bit in a couple of day.
So, it is catching we crept up a little bit. The remainder of the inventory TRUVADA, VIREAD had very little movement in quarter-over-quarter.
One exception in that is Hepsera, Hepsera inventory did trend up a bunch. The magnitude of that, of course, is fairly small compared to the products, but it's up about four to eight and so, it's on the higher end now.
John Martin
Hi, Jeff. In terms of switching and patients, as I think you heard, two-thirds of the ATRIPLA patients came from switch.
That can be basically conversion form our own products. It can be a true switch if you like a whole switch from another company's products.
ATRIPLA actually grew in terms of patients by circuit 30,000. We now have 106,000 patients on ATRIPLA in the first quarter.
TRUVADA drops from 165,000 to 149,000. That is switching going on from typically TRUVADA plus Sustiva.
It was at 40,000 in the fourth quarter and dropped to 27,000 in the first quarter of 2007. But as I think you see, you are starting to see a leveling of TRUVADA, which is starting -- we expected this to happen, you know, in this type of life cycle which is different from VIREAD and the VIREAD conversion to TRUVADA because of course, TRUVADA in itself with the PI describing has very much a light of its own.
So we expected this flattening earlier than we have seen the sort of slowing down in the switch off of VIREAD.
Jeff Meacham - JPMorgan
Okay. Then my second question on the LITARIS.
What impact would you expect the AMB-222 study to have on switches on the patients who are, say, stable on trick there and to LITARIS and is there any sort of early indications that you are seeing switches on to LITARIS versus just new starts?
Kevin Young
Well, hi, Geoff, it's Kevin again. The 222 study has been very powerful in our promotion.
But I have to say about that's contained with on a full message of efficacy. If you look at a six-minute walk, both above 50 meters if you look at top time – the time to think of worst think that significant end points in areas one and areas two, as well as the areas e-dating turns of patients on monotherapy of therapy of patients of survival.
So we see it in a total package of differentiating points. We want to make sure that the initial experience with LITARIS is very favorable for the physician and for the patient.
So our clear focus is that the new patients you’ll identified and diagnosed PH patients and secondarily the patient with the elevated LFTs, where previously to this at to chemotherapy or they may have gone on a reduced dose. In terms of (inaudible) if you like in or you might specify the most stable setting.
We haven't got data for that as of today and I certainly can't give you any anecdotal examples this early. But certainly I can give you feedback in terms of new patients and the LFT failures, we are getting switches to LITARIS.
Jeff Meacham - JPMorgan
Okay. Thank you.
Operator
Your next question comes from the line of Ian Somaiya with Thomas Weisel Partners. Please proceed.
Ian Somaiya - Thomas Weisel Partners
Thanks for taking my questions. I have two questions for Norbert.
First on 9137, can you just talk about what the implications are of a head-to-head study in terms of potential clinical trial in enrolment time, as well as clinical timelines?
Norbert Bischofberger
I don't think actually enrollment should be faster than in the typical, historical placebo control study because you are assured -- the patient is assured to be at least on an ingrate abettor. What either be (inaudible) taker of your versus elbow and take of your – and both are excellent compounds.
I think enrolment if anything should be faster.
Ian Somaiya - Thomas Weisel Partners
Okay. And the other question was on GS9190.
Just getting your typical high standards Norbert, can you just help us define what is encouraging antiviral activity means?
Norbert Bischofberger
I don't want to quantify for you, Ian, but the reason I said encouraging is because it's single dose. This really we have one -- you administer one single dose and it's not an astronomical dose.
It's hundreds of milligrams. You can see it's sophistically significant viral load reductions.
That’s what we say by encouraging or by doing multiple doses, this is only going to increase.
Ian Somaiya - Thomas Weisel Partners
Okay. Thank you very much.
Operator
Your next question comes from Yaron Werber with CitiGroup. Please proceed.
Yaron Werber - CitiGroup
Yes, hi. Good afternoon.
Thanks for taking my question. My first question that I wanted to talk about is can you comment a little bit -- there's been a little bit of publicity about the challenges or the request to have your various patents to reconsider the U.S.
PTO that was excepted and typically they will accept any such request. Can you comment as to what your thoughts are on that and in terms of some of the -- some of the concerns that the 708 initial application did not discuss what is ultimately provided for the next four patents?
And then I have a follow-up question as well?
John Milligan
Yeah Ian this is John Milligan. We can't take a lot in this situation.
But what we can say that this is a highly technical matter that's being picked on. We are very confident we will be able to resolve it.
We don't believe it threatens the substance or the intellectual property attachment to VIREAD or any of our other HIV products and basically that's all we can say.
Ian Somaiya - Thomas Weisel Partners
Okay. And can you talk a little bit -- there's some concerns as to what the level of demand for Tamiflu might be going forward, certainly on the stockpiling side.
This quarter again was a very strong quarter in terms of demand but it sounds like from what Roche and Tamiflu that perhaps demand is going to be softening going forward. Certainly stockpiling can't last forever.
How do you guys look at Tamiflu as a revenue driver for you? And, you know, inevitably, if the stockpiling begins to get to go down, how do you look at that sort of step down in the relative revenues and how do you manage the business and both on the revenue and the expense side to really handle that?
John Milligan
Yeah, well one side maybe continue to grow the product revenue to replace that. I pleased again that we were over $1 billion in total revenue as we have been able to soften the blow the decrease in Tamiflu event in this year.
But you are right at some point, the stockpiling will likely decrease. We don't have good vision for that and frankly neither does Roche for managing the stockpiling on a yearly basis inline with a various governmental organizations and their fiscal cycle.
We do have, you know, very little vision beyond 2007 as to what the additional orders might be. We will learn more of that as we get into the second half of this year and the budgets are set around the world.
So that something we don’t -- we can't give you any guidance on. We don't quite frankly know ourselves.
On the other hand, Roche has had a very strong commitment to increasing the use in the consumer segment, so that we have the prophylaxis, and the treatment options going forward. I think the addition of the new pills for children will help quite a bit because this was essentially hard to get.
People didn't like storing it in the pharmacies and it was often sold out. So I think this will help us quite a bit in that area.
I know that they are committing significant resources to the '07, '08 flu season to try to really start to replace that revenue stream of their own, because they have the same issues that we do, trying to replace that and there's a big commitment from the group to do that.
Operator
Your next question comes from the line of Jim Birchenough with Lehman Brothers. Please proceed.
Jim Birchenough - Lehman Brothers
Hi guys a couple of follow-up questions just in terms of futures stockpiling and as it pretends to the pediatric formulation. If a percent of stockpiling is for pediatrics and would that be one area where we might see future growth in stockpiling, if there's a replacement of the current pediatric stockpile?
John Milligan
Yeah its difficult question Jim. We don’t really know, I mean sorry what I can tell you.
The stockpiling for kids has been very close to zero. What some organizations have done is bought the powder in a way that they could then just try to put it into water and shake it up, but that's proven to be very difficult to maintain and as you can imagine the logistical nightmare trying to contribute that in a panic would be more complicated than any government could handle.
So there's the potential for stockpiling obviously. We don't yet know if governments are putting in orders for that.
But that was one of the key drivers for getting those products approved so that there would be the ability to cover kids. Which are very, very important part of stockpiling you can imagine and at very high risk because of the lack of strong immune system often toward this off.
Jim Birchenough - Lehman Brothers
Just a follow-up question on HIV dynamics in Europe and number one, just wondering as you look at continued growth for TRUVADA and switches that you are getting, can you quantify what's available still in terms of the potential switch business? And secondary to that, I just want to make sure that I understand for ATRIPLA that requests that were made of you previously for food effect studies, that you actually have that data, if it's requested for ATRIPLA here?
Norbert Bischofberger
I will take your second question quickly. It's not the question of food effect.
It has to do with how do you administer ATRIPLA, when its two components have to be given, one without food and the other own with food and what data do you provide to show that if you can give ATRIPLA without food, that essentially the clinical outcome is the same and that’s the debate. It's not one of having done of food kind of stuff.
Jim Birchenough - Lehman Brothers
Okay.
John Milligan
But in terms of Europe, as I said, we achieved leading brand in RTI in the big five markets, but we have yet to get the leading molecule. So, that's encouraging as far as we are concerned because there's certainly room to grow.
We are quite close in a country like Germany. That was one of our first markets that we launched TRUVADA.
There are currently 48,000 Combivir based regimen patients out there in the big five market. So clearly the opportunity is there for us.
As I said, we are getting 144-week data out IAS and Europe, we can typically use that data to promote before we get label changes here in the U.S.. So, that's clearly a healthy group of patients that we think can benefit from TRUVADA.
And I also said, we're not getting as higher proportion of the new patient starts. We are currently getting about 50% of the new patient starts.
So again, there's room for us to grow there. We do have more competition in terms of Kiveza, but we believe we’re handling that competition well and the growth opportunity is there.
Jim Birchenough - Lehman Brothers
Okay. Thanks for taking the questions.
Operator
Your next question comes from the line of Mike King with Rodman & Renshaw. Please proceed.
Mike King - Rodman & Renshaw
Thanks for taking the question. Apologies for the background noise, can you guys just give us a sense of the other international, you may have to address this in your formal remarks, but I may have missed it.
I'm just wondering how we should look at that? Is that going to be, are the numbers that you reported for the quarter are a base of what you’ll grow or will those numbers continue to be sort of random as different contract issues in different countries around the world?
John Milligan
Mike, your question is specifically about the ROW international sales?
Mike King - Rodman & Renshaw
Correct.
John Milligan
Yes, because we mentioned and one thing we pulled out was the $10 million tender in Mexico which was little by abnormal. And again, there are orders that come in on a non-regular basis, so it does have a tendency to bump around.
We are very pleased with the growth of TRUVADA in Mexico, but we suspect that this order does contain some aspect of things that probably could have been ordered in Q1 and weren't and might go into Q3 as well. So I wouldn't expect that number to be reproducible.
And then as always, we have uncertainty regarding Brazil as to when they’re going to order, when they’re going to accept shipments and things like that. I don't have the ability to predict it to you, but I think you are correct and that, there could be variability quarter-over-quarter in the segment.
John Martin
Yes, it can be lumpy, Mike, as John said. I think particularly in Mexico, the government program there is very enthusiastic about using TRUVADA, which is one of our middle-income countries.
But we see very good enthusiasm to incorporate in their program. And I should also say, I think, a country like Australia is doing very nicely with TRUVADA, as well.
Mike King - Rodman & Renshaw
Are you willing to say at this point, what, how big that component could be for all the different , ATRIPLA and TRUVADA, ultimate market potential for ROW?
John Milligan
Mike I don’t want to give that number. Off the top of my head, I don't have a forecast here for it and I think, I would be reluctant to break that out even if I had it.
Mike King - Rodman & Renshaw
No worries.
John Milligan
Thanks.
Mike King - Rodman & Renshaw
Great. Appreciate it.
Operator
Your next question comes from Michael Aberman with Credit Suisse. Please proceed.
Michael Aberman - Credit Suisse
Great, thanks. Going back to the Tamiflu and maybe this is a simple question, do have a shelf life for those pandemic sales and do you expect any reoccurrence once that expires?
John Milligan
The pandemic sales, including the new capsules that were just approved for the pediatrics are five years. So they are -- so there is a limit to the stability that can be use.
Couple of things are going on here, one of which is, the agencies are working with Roche to see if they can extend that shelf life. So there is the possibility that they could get a provision where they could extend that.
We don't know how that will play out because five years is about the limit of where a capital typically starts to fall apart based on the Gelusil capsule itself. And the second point is, we don't know what the future will look like and whether governments would at that time begin to re-order or not.
It is clear that they are thinking about cycling this because as we have seen sales over the last couple of years, the governments have been buying things in stages so that not all of the talents will expires at once. And so should they need to reorder in the future, then they would have portions that would still be good wherever place it.
Mike King - Rodman & Renshaw
And the second question is on VIREAD and HPV and how are you thinking about positioning and as you get closer to market, you mentioned some of the cannibalization, but also how does that pricing, as we know as their attrition can turn there how are you thinking about that in advance of launching it hepatitis B?
John Milligan
Michael, very quickly, I think certainly based on the top line results there obviously is a great profile for VIREAD in HPV. It's been significantly different on the end points in both the 102 and 103 study.
So we really do think we have got an excellent product and it will be first in our detail and it will be very much, the concentration of our efforts. So we'll essentially, at the launch of the VIREAD switch, of total promotion from Hepsera to VIREAD.
But as I said earlier in the call we do expect that a lot of patients who are well controlled with Hepsera. And we shouldn’t forget that we have very good five years dates on HEPSERA.
They will remain on it on Hepsera and it will largely a new patients that we will we hope acquire with VIREAD.
Mike King - Rodman & Renshaw
I guess the question am I asking is, am I wrong in modeling the price is same as HIV?
John Milligan
No, you are correct. It's exactly the same price.
Mike King - Rodman & Renshaw
Is that come to a lower priced per year than Hepsera?
John Milligan
Yes. Yes.
Basically the price of VIREAD are work currently has fallen $82 per month, and for HEPSERA it's $602 per month WAC.
Mike King - Rodman & Renshaw
Okay. So that’s the question?
John Milligan
Yeah so there's obviously a difference of over a $1,000 a year based on the WAC price that we would have to make up in volume which is what we believe we could do given the profile of VIREAD and given the increasing awareness of the importance of treating this disease to prevent not only cirrhosis, but primary liver cancer.
Mike King - Rodman & Renshaw
Got it. Thanks.
Operator
Your next question comes from the line of William Ho with Banc of America. Please proceed.
William Ho - Banc of America
Hi, great. Thanks for taking my question.
Just quickly so far you have been able to grow ATRIPLA nicely without cannibalizing too much of your TRUVADA sales. In the last quarter your patients had dropped from 165 to 149, how did sales in the U.S.
remain roughly flat and how much more did you believe you can grow ATRIPLA without much impact to TRUVADA sales?
John Milligan
Yes, these pools done always match up entirely because of the way we do the audit. So it was mostly flat quarter-over-quarter.
If we look specifically at TRUVADA inventory, it actually went down a little bit. So it wasn't an inventory, issue with that.
I think what you are seeing is that the difference between one, only a slight statistical difference that was there between 165 and 149. So it's probably more of the error rate in the audits that go on than anything else.
I think the numbers are probably about the same for the TRUVADA patients quarter-over-quarter.
William Ho - Banc of America
And how much do you think you can grow ATRIPLA before you start to see an impact in those TRUVADA sales?
John Milligan
Well as I've said I think we're going to see as we are getting to the latter part of the year, that TRUVADA does level off because of its opportunity with PIs. There has been some shifting within the new patient sort of mix between PIs and NNRTIs but in the overall in the total 500,000 patients it's still is about 50/50.
John Martin
But there's still, you know, 40% of patients have come out protease inhibitors. And those patients are more often they are not using TRUVADA.
So we start opportunity to capture lot of new patients with TRUVADA and I think that's where we one of the reason why we are seeing the flattening now and still the popularity with PI and many doctors regimen.
William Ho - Banc of America
Thank you.
Operator
Dr. Milligan there appears to be no more question at this time.
John Milligan
Thank you operator. And thank you all for joining us today.
We appreciate your continued interest in Gilead and look forward to providing you updates on our future progress.
Operator
Thank you for your participation in today's conference. This concludes the presentation.
You may now disconnect. Good day.