Oct 21, 2009
Executives
Susan Hubbard – IR John Martin – Chairman and CEO Robin Washington – SVP and CFO Kevin Young – EVP, Commercial Operations Norbert Bischofberger – EVP, R&D and Chief Scientific Officer John Milligan – President and COO
Analysts
Geoff Meacham – JPMorgan Mark Schoenebaum – Deutsche Bank Michael Aberman – Credit Suisse Rachel McMinn – Bank of America Karim de Felipe – Citi Geoff Porges – Bernstein Joshua Schimmer – Leerink Swann Steve Harr – Morgan Stanley Jason Kantor – RBC Capital Markets Davis Bu – Goldman Sachs Phil Nadeau – Cowen & Company Tom Russo – Baird Jim Birchenough – Barclays Capital Bret Holley – Oppenheimer John Sonnier – William Blair
Operator
Ladies and gentlemen, thank you for standing by and welcome to the Gilead Sciences third quarter 2009 earnings conference call. My name is Melanie and I will be your conference operator today.
At this time all participants are in a listen-only mode. Later, we will conduct a question-and-answer session.
As a remainder this conference call is being recorded today, October 20th, 2009. I would now like to turn the call over to Susan Hubbard, Vice President of Investor Relations.
Please go ahead.
Susan Hubbard
Thank you, Melanie and good afternoon everyone. Welcome to Gilead’s third quarter 2009 earnings conference call.
We’re pleased you could join us today. We issued a press release this afternoon providing results for the third quarter ended September 30th, 2009.
This press release is available on our website at www.gilead.com. We have also posted slides that outline the topics discussed on this call.
Joining me today 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.
I would first like to remind you that we will be making statements relating to future events, expectations, trends, objectives, and financial results that constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These statements are based on certain assumptions that 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 31st, 2008, Form 10-Q’s for the first second quarter of 2009, subsequent press releases, and other publicly filed SEC disclosure documents for a detailed description of risk factors and other matter related to 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
Good afternoon everyone and thank you for joining us today. The third quarter of 2009 was financially excellent and productive on many levels.
Product revenues for the quarter reached a record high of $1.65 billion. Our antiviral franchise continued its momentum in gaining share across all our commercial markets with record revenues of $1.47 billion.
Importantly, we generated $861 million in operating cash flow. In July, we were very pleased to welcome Kevin Lofton to Gilead’s Board of Directors.
Kevin is currently the President and Chief Executive Officer of Catholic Health Initiatives, a Denver-based healthcare system operating the full continuum of services from hospitals to home health agencies throughout the nation. His expertise and knowledge of real-world hospital administration and patient care issues will prove invaluable to our Board and our management team and I look forward to learning from his contributions and insights.
On the regulatory front, in September, the European Commission granted conditional approval of Cayston, our inhaled antibiotic for the treatment of chronic pulmonary infections due to Pseudomonas aeruginosa in adult with cystic fibrosis. We plan to begin making the product available in Germany and the U.K.
in the early part of 2010. Also, during the third quarter we received conditional approval for Cayston in Canada.
Cayston is the first new inhaled antibiotic to be licensed for the treatment of cystic fibrosis in a decade and it has the potential to improve the lives of patients suffering from this disease. And before I turn the call over to Robin to review our financial results, I would like to highlight two very important developments for patients with HIV/AIDS on the U.S.
policy front. First, in early September, the U.S.
Department of Health and Human Services announced a proposal to add HIV screening test to Medicare’s list of covered preventive services. This proposal would mean that Medicare would cover annual voluntary screening of those at risk for HIV infection as well as women who are pregnant.
A final decision regarding this proposal is expected in December. Secondly, on September 30, the Senate Health Education Labor and Pension or HELP Committee approved draft legislation that would extend the Ryan White Treatment Act through 2013.
This measure would authorize $2.35 billion in funding in fiscal 2010 with annual increases through 2013, for which $2.75 billion would be authorized. In addition to access to care and treatment, the treatment act would, for the first time, establish a national goal of administering five million HIV test each year.
As you may know, just under a quarter of the patients in the United States received antiviral therapy through state AIDS Drugs Assistance Programs under this Ryan White Act. And this extension would ensure continuity for those currently treated and create the opportunity to diagnose more patients, bringing them into care and onto therapy.
Final adoption of this legislation is expected by the end of October. For policy developments, here at Gilead we have exciting progress to share in terms of our marketed [ph] products and our pipeline programs.
I will turn the call over to Robin who will begin by reviewing our financial results for the third quarter.
Robin Washington
Thank you, John. I am very pleased to provide you with Gilead’s financial performance for the third quarter of 2009.
The total revenues, which include product sales and royalty, contract and other revenues, were $1.8 billion, a 31% increase year-over-year. Net income was $673 million, or $0.72 per share.
Non-GAAP net income for the third quarter, which excludes the impact of after-tax acquisition-related expenses, restructuring expenses, and stock-based compensation expenses, were $730 million or $0.78 per share, representing a year-over-year increase in the net income and EPS of 39% and 42%, respectively. Product sales were $1.65 billion.
Antiviral product sales grew to $1.47 billion, up 19% year-over-year and 4% sequentially. Truvada sales contributed $621 million to our antiviral product sales, up 13% year-over-year, due primarily to sales volume growth in both the U.S.
and Europe. Truvada sales increased 2% sequential.
Atripla contributed $605 million to our antiviral product sales. Atripla sales increased 42% year-over-year and 6% sequentially, resulting from the continued uptake of the product in the U.S.
and Europe. The efavirenz portion of Atripla, which is purchased from BMS at its estimated market price and reflected in cost of goods sold was approximately $222 million.
Viread sales were $170 million, representing an increase of 9% year-over-year and 7% sequentially. Hepsera generated sales of $68 million, a decreased of 26% year-over-year and an increase of 1% sequentially.
Letairis sales were $48 million, an increase of 52% year-over-year and 9% sequentially, driven primarily by sales volume growth in the U.S. Finally, Ranexa sales were $49 million for the third quarter.
This represents an increase of 18% sequentially after normalizing the second quarter sales for the period prior to our acquisition of CV Therapeutics on April 15th. Foreign currency exchange had a net unfavorable impact of $51 million on revenues when compared to the same period last year.
On a sequential basis, foreign currency exchange had a favorable impact of $18 million. Our royalty, contract and other revenues for the third quarter were $152 million, an increase of $120 million year-over-year and an increase of $74 million sequentially.
Both the year-over-year and sequential increases were primarily driven by increased Tamiflu sales related to pandemic planning initiatives worldwide. Royalties received from Roche for Tamiflu sales and recognized in our revenues in the third quarter were $113 million.
These royalties which can take one quarter in arrears reflect a royalty rate of approximately 21% as applied to Roche’s net sales of Tamiflu during its second quarter of 2009. Tamiflu royalties represented approximately $0.09 in earnings per share during the third quarter.
During their third quarter 2009 earnings call, Roche reported 994 million Swiss francs for Tamiflu worldwide sales in third quarter 2009. This translates into approximately $195 million in royalties payable to Gilead in our fourth quarter, or approximately $0.16 per share on a fully diluted basis.
It is important to note that the following discussion of our margin and expense related items are on a non-GAAP basis, which excludes the impact of acquisition, restructuring, and stock-based compensation related expenses. Product gross margin was 76.5% compared to 78.1% for the same quarter of last year and relatively flat compared to the second quarter of 2009.
The year-over-year decrease was due primarily to the higher proportion of Atripla sales, which include the efavirenz component at zero gross margin. Operating margin was 53.9% compared to 53.6% for the same quarter last year and 52.4% for second quarter 2009.
Our year-over-year and sequential operating margins were favorably impacted by the increase in Tamiflu royalties as well as continued and focused cost management, partially offset by the R&D expenses reimbursement related to the Tibotec TMC278 collaboration. During the third quarter, we have also begun to realize significant operational efficiencies from the integration of CV Therapeutics.
We continue to see improvements relative to 2008 in our core operating margins, which excludes Tamiflu and efavirenz. R&D expenses were $242 million, an increase of 42% on a year-over-year basis and an increase of 18% sequentially.
The year-over-year increase was due primarily to the Tibotec R&D expense reimbursement, increased clinical study activity, and additional hiring associated with the overall growth of our business. The sequential increase was due to the effects of the Tibotec expense reimbursement, partially offset by the integration of our combined cardiovascular operations and lower clinical study expenses.
SG&A expenses were $200 million, an increase of 19% year-over-year, due primarily to higher headcount and investments associated with overall growth of our business, including the CV Therapeutics acquisition. On a sequential basis, SG&A expenses decreased 6% due primarily to promotional spend seasonality in our international operations and synergies realized from the integration of CV Therapeutics, partially offset by expanded sales and promotional expenses for Ranexa, which Kevin will speak to.
Other income and expense reflected a net expense of $3 million for the third quarter, a decrease from a net expense of $13 million for the same quarter last year, due primarily to lower hedging expense and a more favorable foreign exchange translation gains and losses, partially offset by lower year-over-year investment yields. Sequentially, other income and expenses was $2 million favorable.
Our effective tax rate for the third quarter was 24.8% compared to 27.5% for the same quarter last year and 24.7% for the second quarter of 2009. The year-over-year decrease was driven primarily by increased earnings in the lower tax jurisdictions and the extension of the federal research tax credit in the fourth quarter of 2008.
Next, I wanted to provide an update on our restructuring activities. As discussed last quarter, we’ve developed and communicated a restructuring plan to realign the cardiovascular operations of Gilead and CV Therapeutics.
We have completed the integration and have incurred approximately $33 million in pre-tax restructuring expenses to-date with $8 million incurred during the third quarter. We expect to incur additional restructure expenses of approximately $28 million through 2010, which includes approximately $16 million in the fourth quarter of 2009.
We generated $861 million in operating cash flow during the quarter. We also repurchased 6.2 million shares of our common stock at a cost of $288 million and unrealized $200 million to pay down half of the $400 million credit facility that we accessed in the second quarter.
As of September 30th, 2009, we had approximately $242 million remaining for share repurchases under the $3 billion share repurchase program scheduled to expire at the end of 2010. We ended the quarter with a strong balance sheet position.
Our cash and marketable securities portfolio of $3.3 billion allows us the continued flexibility to pursue opportunities to expand our business and return value to our shareholders, as appropriate. Now turning to guidance for the year, which is available on our corporate website.
Based on strong financial performance for the first nine months of 2009, we expect net product revenues for the full year 2009 to be approximately $6.35 billion, which is higher than our previous guidance of $6.1 billion to $6.2 billion, and which reflects a 25% increase over 2008 net product revenues. Factors that may have an impact on our business include, but are not limited to, the potential for continued volatility in foreign exchange rates, U.S.
and international government pricing pressures, and changes in the financial health and our practices of our business partners and customers. Please note that the non-GAAP product gross margin and operating expense guidance provided to you excludes the impact of acquisitions, restructuring, and stock-based compensation related expenses, where applicable.
Our non-GAAP product gross margin for 2009 remains unchanged and ranges from 76% to 78%. For expenses, we are decreasing non-GAAP R&D expense guidance from a range of $850 million to $870 million to a range of $810 million to $830 million.
This guidance includes the 2009 R&D expense reimbursement payable to Tibotec for the development cost associated with TMC278. Non-GAAP SG&A expense guidance remains unchanged and ranges from $810 million to $830 million.
Our effective tax rate guidance for the full year 2009 is expected to remain in the range of 26% to 27%. And finally, we are maintaining the full year diluted EPS impact of acquisition, restructuring, and stock-based compensation related expenses at a range of $0.23 to $0.26 per share.
Additional details can be found on our corporate website. 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. I am pleased to share with you the solid commercial performance for the third quarter, and especially our HIV results.
During the third quarter, the total U.S. antiviral product sales were a very healthy $805 million, led by Atripla at $408 million, up 18% year-over-year, and Truvada at $293 million, up 12% year-over-year.
Prescription demand during the quarter for both Atripla and Truvada were particularly robust. As highlighted in our second quarter earnings call, we did see a rise in inventory levels as a result of wholesalers anticipating a July price increase.
In the third quarter, we saw this situation reversed with the second quarter buying largely taken out and inventory returning to levels in line with the first quarter. In the third quarter, non-retail purchases, primarily those linked to state AIDS Drug Assistance Programs were consistent with the buying pattern of the previous financial year, albeit stronger than the third quarter of 2008.
As a remainder, patient data for the U.S. lags our financial results by one quarter.
In the second quarter of 2009, the number of patients treated with antiretroviral therapy grew by 6% on a moving annual total basis to approximately 571,000 patients. Atripla, the most prescribed regimen in HIV, had 180,000 patients on therapy, or nearly a third of all treated patients, and captured approximately 505 of treatment naïve patients.
Truvada continued to grow to a total of 211,000 patients on therapy, or 37% of all treated patients, maintaining its position as the backbone of choice for antiretroviral therapy in the U.S. Total Truvada or Atripla together with Truvada continued to account for approximately 85% of patients new to therapy and the products now are the components of all of the top six prescribed regimens in HIV.
It is also encouraging to see the growth of the newer (inaudible) agents in the naïve setting is coming in tandem with Truvada. Approximately 61% of Raltegravir patients and 92% of Darunavir patients are co-prescribed Truvada.
Our HIV products in Europe continue to perform well, led by Truvada, which contributed $293 million of revenue in the third quarter, up 40% from the same period in 2008. In our first full quarter with Atripla launched in France, Atripla revenues were $182 million, up 18% sequentially.
The uptake dynamics for Atripla within the French market are encouraging and while it is still early we have seen similar characteristics to that of the U.S. even those protease inhibitors are a more popular third agent class in France We anticipate launching Atripla in three additional international markets where Gilead has a commercial presence with Belgium in the coming weeks and Australia and Switzerland to follow in the first half of 2010.
In the early Atripla launch countries, namely, Germany, Spain, and the U.K., we now have the number one and number two brands in Truvada and Atripla. The big five countries of Europe continue to show robust growth with approximately 281,000 patients treated with antiretrovirals at the end of the second quarter 2009, representing a growth rate of 7% on a moving annual total basis.
Approximately 25% of the patients receiving Atripla converted from Truvada plus Sustiva in the third quarter 2009 whilst 31% were switches from other regimens and 44% of patients were naïve. Total Truvada increased its share to approximately 74% of treatment naïve patients, up from approximately 68% in the third quarter of 2008 while Kivexa’s share remained at 11% in the third quarter of 2009, down from approximately 16% in the third quarter of 2008.
Total Truvada achieved new highs in the NRTI market, outperforming Kivexa with a prescription ratio of 3.4 to one in July 2009, up from 2.6 to one in July 2008. Now, turning to our U.S.
hepatitis franchise. Estimated total Viread HBV prescription grew by 21% quarter-on-quarter, more than offsetting the decline in Viread HIV total prescriptions and generating a 5% quarter-on-quarter increase in Viread prescription volume across both indications.
The latest September monthly data point for total HBV prescriptions have Viread at an estimated market share of approximately 30% and Hepsera at 22%. As of the most recent data point in July 2009, Viread had achieved a 40% naïve patient share in the HBV market, marking the second consecutive month that Viread was at a naïve patient share at or above that of Entecavir.
We are very pleased with the recent addition to our U.S. label of 96-week data from our pivotal studies 102 and 103 as well as 48-week resistance data from study 106.
In Europe, Viread for HBV is reimbursed in 16 countries, with international launches anticipated in Belgium, Poland, and Australia in the fourth quarter of 2009. Supported by guideline endorsements for use in both naive and lamivudine experienced patients and a positive recommendation from the U.K.
National Institute for Health and Clinical Excellence, Viread has surpassed Entecavir in Germany, Spain and the U.K., our first countries of launch. As of July 2009, Viread’s HBV market share in Europe was estimated to 16% versus 9% at the start of the year.
In Turkey, where we established our affiliate specifically for the launch of Viread HBV, we have achieved a 21% market share one year post-launch and are making gains on Entecavir, which holds 29% market share. Now, turning to our cardiovascular franchise.
We continue to make progress with Letairis for the treatment of pulmonary arterial hypertension, supported by our update label, removing six-month re-enrollment requirements in the lead program as well as our recent introduction of LabSync, which is designed to reduce the burden of monthly lab monitoring. During the quarter, Ambrisentan [ph] received the treatment indication for WHO functional class II patients.
Along with that approval, the FDA added a considerations for use section to the label, which states that physicians should consider whether benefits offset the risk of liver injury in this class of patients. As a reminder, Letairis was immediately approved for WHO functional class II and does not carry this safety warning.
Thus, we continue to believe we have a best-in-class ERA for PAH with a distinctive profile from the sulfonamide structure ERA’s, namely bosentan and sitaxsentan. According to our latest data, as we exited the third quarter, approximately one in three patients receiving an ERA was taking Letairis And finally, turning to Ranexa.
Total U.S. sales for Ranexa during the third quarter were $49 million.
This figure included $3.9 million in bulk [ph] tablets supplied to Menarini, our licensee for Ranexa in Europe. During the quarter, we did see a modest increase in Ranexa inventories to our days on hand for Ranexa now modeled that of our HIV franchise.
Additionally, we had a one-time Ranexa benefit as we began transitioning certain of our U.S. wholesalers to Gilead inventory management agreements.
We have made a great deal of progress on the operational plan for Ranexa that I laid out on our last earnings call. We have completed the hiring and initial training of our new 200-person sales force.
And as of Monday, this team began field promotion with a new visual aid, a new sample policy, and the new co-pay program. We have revamped the previous Ranexa co-universe [ph] based on angina prescribing potential, mixing both cardiologists and internal medicine specialists, 30% of whom are entirely new targets.
In conjunction with this work, we cancelled the primary care pilot program instigated a year ago by CV Therapeutics. The rebuilding of a field-based medical science team is nearly complete and they will be supported in their work by an extensive continuing education program focused on the treatment of chronic angina.
Finally, we have set in motion a new and expanded Ranexa speaker [ph] program that will highlight the benefits of Ranexa according to our new label. I am encouraged by the first-hand feedback I have received during field visits and advisory boards and I look forward to keeping you updated on Ranexa progress as our activities gain traction in 2010.
I will now turn the call over to Norbert to discuss our R&D efforts.
Norbert Bischofberger
Thank you, Kevin. On the research and development front, we are now in the final stages of completing an annual review of our R&D portfolio, a process in which we assess the progress as well to evolve a medical and commercial opportunity to our various product candidates and programs across our four therapeutic areas, namely, HIV, liver diseases, respiratory diseases, cardiovascular metabolic diseases.
I am pleased that we have a number of very exciting opportunities available to us and that between now and the end of 2010 we expect numerous and important data sets to emerge from these efforts. First, on the cardiovascular metabolic front.
The results of the DAR-311 study were published online and will appear in next week’s print edition of The Lancet, showing that Darusentan was effective at reducing trough sitting and mean 24-hour systolic and diastolic blood pressure after 14 weeks of treatment in patients with resistant hypertension. DAR-311 is one of two ongoing Phase III clinical trials evaluating the safety, efficacy, and tolerability of Darusentan as an add-on treatment for resistant hypertension.
The second study, DAR-312 is expected to be completed with data available by the end of 2009. DAR-312 is an international Phase III double-blind, placebo- and active-controlled, parallel group trial, in which 849 patients were randomized to receive Darusentan titrated to the optimal dose of 50,100 or 200 milligram once daily, or an active comparator guanfacine or placebo.
The co-primary efficacy endpoint of the trial are the changes from baseline to week 14 in trough sitting systolic and diastolic blood pressure. Importantly, we will also learn more about the safety of Darusentan, particularly with regards to edema and cardiovascular safety events [ph].
There are also a number of additional indications and opportunities for Ranexa and follow-on late sodium channel inhibitors. Based on this higher product profiles, we will pursue some of these opportunities with Ranexa itself and some of them with new chemical entities emerging from our research efforts.
We are also moving GS 9667, partial adenosine a1 agonist into a Phase Ib study. This compound has previously shown in a single ascending dose study to lower plasma-free fatty acids.
The Phase Ib study will assess the effect of GS 9667 on plasma triglycerides on glycemic control and insulin sensitivity. In addition, we are exploring the utility of Letairis for the treatment of non-WHO Group 1 pulmonary hypertension patients.
We are currently screening patients in a Phase III study, exploring the utility of Letairis for the treatment of pulmonary hypertension, secondary to IPF. The safety and efficacy of Letairis will be determined in this placebo-controlled study with six-minute walk [ph] distance as the primary efficacy endpoint.
On the respiratory front, as John Martin mentioned, we are very pleased that Cayston has received conditional approval both in the EU and Canada. We continue to work with the FDA to determine the path to approvability for the product in the United States.
Our Head-to-head study of Cayston versus TOBI, which would support full approval in EU and Canada, and potentially support the approval in the United States, will be fully enrolled by the end of this year with data available from that study towards the middle of next year. With regards to GS 9411, our epithelial sodium channel blocker, or ENaC inhibitor we have successfully completed two Phase I studies designed to assess the safety of a single ascending dose of the compound.
We are now initiating a multiple dose study in healthy volunteers, which will be completed by the end of the year. We will also initiate a single ascending dose study in patients with cystic fibrosis shortly.
As an ENaC inhibitor, this compound is designed to stimulate and increase airway hydration and therefore could have application beyond use in patients with cystic fibrosis. Based on positive data, safety data from the Phase I studies, we are preparing to initiate a proof of concept study in patients with chronic obstructive pulmonary disease.
In addition, the Phase III study of Letairis for the treatment of IPF is continuing to enroll patients. With regards to our efforts in hepatitis C, as you know the current standard of care for the treatment of patients with chronic hep C is the combination of peg-interferon and ribavirin, but there are many patients that either do not respond to or can't tolerate this regimen.
Therefore, the focus of industry’s effort in this area is to develop direct antivirals to increase cure rates, to improve the safety and tolerability and to reduce treatment duration. Initially, these new compounds are being developed as an add-on to peg-riba therapy, but a shift in the treatment paradigm will require a combination antiviral therapy with much more limited or no use of peg-riba.
While our focus to-date has been to develop GS 9190, our polymerase inhibitor, on top of peg-riba in a Phase IIb program, our research efforts have been focused on the identification of other small molecule antivirals that we could develop in combination with GS 9190. And the identification of such a lead compound would prompt a shift in our development strategy for GS 9190.
We now have that candidate in GS 9256, an HCV polymer – protease inhibitor. Because of this progress, we have decided that rather tan pursue the untested path with regulatory authorities of advancing 9190 into an accelerated Phase III program, we will now focus our resources on development of GS 9190 in combination with our new protease inhibitor.
And in parallel, we will continue our GS 9190 Phase II study looking at 12- and 24-week SVR data, which we will have next year to see if GS 9190 has the profile that would allow it to be further developed on the back of peg-riba. I am certain that many – you have many questions about our new protease inhibitor, but we have not yet presented data on this compound and for competitive reason will not go into any further detail about it or the data we have generated to-date other than to say that we have sufficient comfort with the emergent antiviral activity and safety profile of GS 9256 to advance it further in combination with 9190.
Our caspase inhibitor, GS 9450, continues to make progress as a hepatoprotectant both in HCV and NASH. Positive results generated earlier this year from a Phase IIa study in patients with HCV supported the compound’s advancement into a Phase IIb trial, which is a randomized placebo-controlled, multi-center study to investigate the safety, tolerability, and efficacy of two doses of GS 9450 or placebo in adults with chronic HCV infection.
We are enrolling patients in this study and are currently more than a quarter enrolled. This study has a 24-week efficacy endpoint as assessed by liver histology.
In addition, we have recently completed dosing in a Phase IIa study of GS 9450 for NASH with data analysis ongoing. This was a randomized, placebo-controlled, multi-center study designed to investigate safety, tolerability, pharamacokinetics, and activity of multiple doses of GS 9450 for four weeks.
We are targeting presenting data from both these Phase IIa studies at a major medical meeting in the spring of next year. And finally, on HIV, at the ICAAC Conference in San Francisco in Mid-September, we had several posters on GS 9350, our novel boosting agent, including one describing the chemical structure and properties of the compound as well as a poster describing its ability to boost Atazanavir, one of the most widely prescribed protease inhibitors to levels bio-equivalent to those seen when boosted with Ritonavir.
These are important data as they supported a Phase II study design of GS 9350 versus Ritonavir in combination with Atazanavir and Truvada in HIV-infected patients. Importantly, we have recently completed the required chronic animal tox for GS 9350, which supports the continued development of this compound.
The quad [ph] and 9350 Phase II programs remain on track and we expect data from both these studies early next year. Should they provide the results we anticipate our goal will be to initiate three full Phase III studies before the mid-point of next year.
The elvitegravir Phase III study head to head versus raltegravir in treatment of (inaudible) HIV patients is soon to complete enrollment, which would put us on track for the results of that study by early 2011. Our efforts to produce the most optimized fixed dose formulation of Truvada with Tibotec’s NNRTI drug candidate TMC278 has yielded two lead single tablet formulations and by equivalent studies wit both formulations are currently underway.
The clinical data sets that would support the filing of the fixed dose in addition to bioequivalence data are the Phase III results from the TMC 278 head-to-head program versus efavirenz in treatment naïve patients. Tibotec has indicated that they will have data from these two studies before the midpoint of next year, which would allow them to file for the single agent TMC 278 for use in treatment naïve patients in the second half of 2010.
As we stated, when we announced the collaboration in July, pending agreement with FDA, we would submit marketing applications for the fixed dose of Truvada and TMC 278 either simultaneously or shortly thereafter in both the United States and the European Union. In summary, we have a number of exciting opportunities both for label extensions of our commercial products and for new chemical entities in development or arising from our research efforts.
I will now turn over the call to John Milligan.
John Milligan
Thank you, Norbert. Over the last two quarters, we acquired CV Therapeutics, successfully integrated the organization at Gilead and began consolidating our cardiovascular operations into California.
Despite all these potential distractions, we were able to continue to increase sales and move our development candidates along. While doing so, we were even able to reduce our overall expenses more than anticipated.
So, as I revenue the financial, commercial, and R&D milestones we achieved during the third quarter, I am very proud of the productivity, focus and efficiency of this lean organization. I thank all of our employees for their dedication and efforts to make this such a successful quarter for Gilead.
In addition, we are very pleased to update you with the progress we have made in our largest ever research HCV with the movement of GS 9256, our protease inhibitor into clinical studies in combination with GS 9190. We also have a number of important clinical milestones in the coming months.
In particular, data from the Phase III DAR-312 study of Darusentan in resistant hypertension before the end of the year. In addition, we will have the Phase II results from both the quad and GS 9350 studies in HIV in early 2010.
There are several important medical meetings between now and the end of the year, including the AASLD Conference in Boston starting at the end of this month where we will present three-year data for both of our pivotal studies of Viread for the treatment of HBV. And we will continue to focus our commercial efforts on the growth of our marketed products, especially the antiviral franchise, and as Kevin described, the implementation of the revamped commercial effort behind Ranexa for angina in the United States.
We thank all of our shareholders for their continued support and look forward to keeping you updated on our progress. I will now turn the call over to the operator for the question-and-answer session.
Operator?
Operator
Thank you. (Operator instructions) And our first question comes from the line of Geoff Meacham with JPMorgan.
Go ahead.
Geoff Meacham – JPMorgan
Hey guys, congrats on the quarter and thanks for taking the question. Question for you, I am trying to reconcile product sales guidance with Kevin’s comments on inventory and if I look at the guidance it implies I think an incremental $35 million or so in 4Q sales and yet Kevin you noted on the call that 3Q inventory levels were below normal so – or were at normal.
So I am just curious if you can give us some comments on both of those.
Kevin Young
So, let me just then go back to the inventory, Geoff. Thanks for the question.
As we said in Q2 earnings, there was a build-up that was about four days of Truvada and Atripla because of the wholesalers anticipating a July price increase, which we did indeed implement. That basically came out in the third quarter.
So we are back to essentially business as usual with our HIV inventory levels. So, we think that will be maintained going into the fourth quarter and throughout the year.
So unless some unanticipated events take place and we never know what’s going to happen there in terms of the practices of our major wholesalers. Our assumption going forward is that we will be operating at current levels of inventory through the fourth quarter.
Robin Washington
Geoff, this is Robin. I will also add just to be clear the new guidance is $6.350 billion, so it actually increased $150 million.
Susan Hubbard
Next question, operator.
Operator
Our next question comes from the line of Mark Schoenebaum with Deutsche Bank. Go ahead.
Mark Schoenebaum – Deutsche Bank
Hi everyone. Thanks for taking my question.
I really appreciate it. John, I am fascinated by the R&D guidance.
Can you give us a little more color as to how you were able to lower guidance, was it efficiencies or was it re-prioritization and maybe not doing some things you thought you were going to do and then when we – now, I know you are not going to give forward guidance beyond ’09, but when – you know big picture way we think about the Company, the R&D as a percent of revenues that you are seeing right now is that a reasonable way to think about the Company over the next few years? Thanks a lot.
John Martin
Thanks for the question, Mark. I will try to remember all three parts to this.
So, on the first part of this – on the first part, we were able to achieve lower projected R&D spending based on really two things, one, we were able to drive greater synergies of the CV Therapeutics acquisition than we have predicted, largely driven by less hiring which would – that would have occurred in our Colorado operations offset by bringing some of the CVT people into our organization. So we were able to make the two organizations much more efficient, much more quickly than we anticipated.
The second part of that was rather – other programs that we are not doing, the answer is there are. We had anticipated potentially going into a larger Phase III study of GS 9190 pending the results from our GS 9256 studies that Phase studies that Norbert – team had been conducting.
And with the decision now to consolidate those two programs together to look at dual antiviral activity of a polymerase and a protease inhibitor, we have now delayed the potential Phase III study pending the SVR 12 and the SVR 24, potentially 24-week data from 9190. So those are costs that would have occurred this year that have been delayed depending on the outcome of that 9190 study.
So those are the two things that we have been able to do to keep our cost in line. And you know the last think is where are we relative to where should be.
I do think we are investing very wisely in the different programs that we have ongoing. And again, I don’t get fixated by a certain percentage of revenue or a certain percentage of an organization.
I do think we are investing in the right thing and I think I agree with Norbert’s assessment. We have a lot of exciting things in pipeline and we will continue to make wise choices as we invest in different opportunities for the future.
Mark Schoenebaum – Deutsche Bank
Okay. Appreciate that.
Thanks, John.
Operator
Our next question comes from the line of Michael Aberman with Credit Suisse. Go ahead.
Michael Aberman – Credit Suisse
Hi guys, how are you? Can you hear me okay.
Susan Hubbard
(inaudible), Michael.
Michael Aberman – Credit Suisse
Okay. I guess can I get a clarification on the quarter again on the ADAP and what we’ve seen this quarter and whether based on annual patterns of ADAP sales whether you can expect some increased ADAP sales in the fourth quarter based on what we’ve seen so far this year and whether that’s a consideration in this guidance?
Kevin Young
Hi, Michael, it’s Kevin. There is always components we look at in our HIV performance.
Obviously there is the best measure, which is the prescription data, the demand data, and that was very robust. Depending on what database you used, it was between 5% and 6% for the quarter.
There was inventory levels and I’ve just described that situation that we had on that. And then thirdly for us there is the non-retail and a big component of that are the ADAP wholesaler purchases.
So that’s primarily Florida, Texas, and Puerto Rico. In terms of the shape of 2009, we are seeing a very similar type of shape where we have the larger Q1, the lower Q2, and then business is returned in Q3.
But I have to say that the sales in Q3 and there was the second quarter of their financial year, was actually very robust for this quarter compared to 2008. Typically, when we look at the ordering patterns of ADAP in their first two quarters, it’s a little bit less than their second two quarters, in other words, Q4 and Q1.
So, we are expecting pretty good performance even though we had a very good quarter for Q3. We are expecting a good Q4 and Q1.
So, we are expecting the kind of the same pattern as 2008 and expectation that just like underlying demand the rest of the year is going to play out in a healthy way.
Michael Aberman – Credit Suisse
Okay.
Operator
Our next question comes from the line of Rachel McMinn with Bank of America. Go ahead.
Rachel McMinn – Bank of America
Yes, just further expand on some of the HCV commentary, I guess I am a little bit confused what it is that you are waiting for. So at this point you should have your 12-week safety data for 9190 and I understand that you would want to see a CRA for 9190 if you are going to develop it alone, but once you have the 12-week safety data, isn’t that sufficient to start combination data with your protease?
Or do you need additional protease data before you can start those trials?
Norbert Bischofberger
Yes, so, Rachel, it’s Norbert. Thanks for the question.
So what we are doing is we are really refocussing from developing 9190 on top of peg-riba, you know the same strategy as telapravir and bocepravir going down the road, and we are refocusing our effort to look at combinations, small molecule antivirals. And so we have the protease inhibitor 9256 and what we are currently doing is a drug interaction study between the two.
You are entirely correct. We have enough safety data, both preclinical tox information and clinical data on the 9190 by itself so that we can go afterwards into combination therapy.
Rachel McMinn – Bank of America
Well, just to wrap it up then you don’t actually need to wait for SVR data for 9190 before you proceed into combination studies?
Norbert Bischofberger
No, no, and you know those – it’s almost – you think of it as a parallel development opportunity so we can look at 9190 in combination with peg-riba for which the SVR data would be relevant, but for the combination 9190 with our 9256 protease inhibitor, we don’t really need any of those data to move ahead. That’s correct.
Rachel McMinn – Bank of America
Okay. Thanks very much.
Operator
Our next question comes from the line of Yaron Werber with Citi. Go ahead.
Go ahead.
Karim de Felipe – Citi
Hi, this is actually Karim de Felipe dialing for Yaron. I have a question on potential guideline changes.
Is that something – I am just wondering if there is any updates, if we could hear of guideline changes to treat HIV patients really based on their (inaudible), is that something that we could hear about in (inaudible) or around that timeframe, is there any update in that sense.
Kevin Young
Hi, it’s Kevin. I think our guess is as good as yours.
I think we get a sense around our HIV world that there is probably a better chance of those guidelines changing. What they will look like in terms of the actual wording, we don’t know and we don’t know the actual timing on that either.
Obviously they are somewhere in the region of about 100,000 patients in the U.S., about 80,000 in the European big five markets that would come under new guidelines if they were taken up to a 500 CD four level. So, obviously that’s an opportunity for our HIV franchise.
I think that together with – as John Martin mentioned, the Ryan White extension for another four years, I think those two coming together at some point would be a real sense of confidence and boost to the HIV community to be treating more patients. So, we have a sense of anticipation that there may be eventually guideline change.
Karim de Felipe – Citi
Thank you very much.
Operator
Our next question comes from the line of Geoff Porges with Bernstein. Go ahead.
Geoff Porges – Bernstein
Thanks very much. Question on the cash to the Johns.
You’ve go $3.3 billion in cash now and $800 million to $900 million a quarter and you’ve cut your R&D spend. So your cash is going to double essentially over the next year.
Should we think that you are just going to continue to do the sort of relatively small bolt-on acquisitions, but more importantly have you contemplated any accelerated share repurchase, probably another one or even considering a dividend? I mean how are you going to use this cash, which is just going to accumulate?
Robin Washington
Hi, Geoff, it’s Robin Washington. As we’ve always said, we always are looking at potential opportunities to in-license or acquire as well as continue to find other ways to strategically give back cash to our shareholders and one has been share buybacks.
We have been consistent in ensuring that we are fine on regular basis to cover over and above dilution, but also we’ve been strategic relative to accelerated share repurchases. So, it’s something that we review all the time.
We do feel that relative to the cash we are generating we have the capabilities to do both now and going forward and will continue to evaluate alternatives as we go. I will point out the $860 million that is a great – it’s somewhat higher relative to our kind of run rate of $600 million to $700 million just due to the fact that we had a significant amount of accruals and higher net income.
We also are generating about – I’d say about 52% of that cash is related to offshore cash that gets generated, which gives us a little less flexibility relative to immediate usage, but I’d say while we continue to analyze and look at our strategy and we’ll continue towards on an ongoing basis as we work with our management team and our Board on other alternative uses.
Operator
Our next question comes from the line of Joshua Schimmer with Leerink Swann. Go ahead.
Joshua Schimmer – Leerink Swann
Thanks for taking the question. I was curios about the ADAP price freeze that I believe is set to expire in 2010.
What do you expect to happen to prices when that freeze goes off? Is there any catch-up, is there any opportunities for future price increases?
Thanks.
John Martin
Our commitment to the ADAP programs goes right till the end of 2010 and I think, Joshua, it will – we will obviously have to consider what we want to do for the federal part of our markets. So, I think it will be a measured decision and what we try to do in the best interest of providing our drugs for people who are underserved.
So, I think that will come down to a kind of a corporate decision.
Kevin Young
Josh, one thing to remember is that those price increases would still be tied to CPI at the time, which has been low or negative in recent quarters. And so I don’t expect that to really add on significant amount to the business.
Joshua Schimmer – Leerink Swann
Okay, fair enough. Thanks.
Operator
Our next question comes from the line of Steve Harr with Morgan Stanley. Go ahead.
Steve Harr – Morgan Stanley
Hi good afternoon. You guys just give us a little bit an update on what is a rate-limiting step for filing TMC278 as a single pill and what is it that you have outstanding from your two formulation or tablets that you are looking at right now?
Norbert Bischofberger
Hi, Steve, it’s Norbert. Steve, it’s actually we need three pieces.
So, first of all, the application for 278 itself has to be filed and as I said in my – previously, data should be available sometime early next year and then the filing should go in, the NDA should go in middle of next year. The second piece is we need to complete a bioequivalent study.
And as I said, the – that bioequivalent study is ongoing. And the third piece, we need just stability data on the co-formulated tablet.
And all of that will be in place by the middle of next year. So the only thing – if we get all these three pieces then we just have to have a conversation with FDA and see whether they allow us a simultaneous filing particular with regards to workload at the review division.
Operator
Our next question comes from the line of Jason Kantor with RBC Capital Markets. Go ahead.
Jason Kantor – RBC Capital Markets
Hi, thanks for taking my question. (Inaudible) confused on the HCV program, so protease inhibitor that is or is not currently in patients and when you think about the combination of protease are you going directly to – can these be co-formulated as the fixed dose combination and when do you think you will actually be in a kind of a proper Phase II combination study with the two drugs.
Norbert Bischofberger
And so, Jason, thanks for the question. So, just to make it clear, the HCV protease inhibitor is in clinical development.
We obviously have completed the initial stages and we are happy with the PK, with the emergent safety and efficacy data and now we are at the point of doing a drug interaction study with the polymerase inhibitor and then we are going to move into combination therapy. In terms of what we are thinking about, there are really two or three possibilities.
You can think about completely very much shortening the peg-riba treatment durations or do something like an induction maintenance approach where you use peg-riba for weeks with the two antivirals and then peel off the peg-riba and continue with two antivirals. If the two antivirals are potent enough, you could also think – you can think about using them by itself.
For instance, in that population where peg-riba is contraindicated. And the third possibility is simply in combination with peg-riba to increase SVR rates.
And again, it all depends on the emerging combination antiviral data. The timing – you also asked me about the timing.
That’s still – I don't want to mention that now, but it depends on a number of things, but it should be sometime first half of next year.
Jason Kantor – RBC Capital Markets
So do you – you are going to be pursuing two investigational drugs ultimately into a Phase III program with two drugs, neither of which is approved?
Norbert Bischofberger
If the two – if the profile of the two drugs, both the potency and the safety is acceptable, then yes, that is our intent.
Jason Kantor – RBC Capital Markets
Fair. Okay.
Thank you.
Operator
Our next question comes from the line of Davis Bu with Goldman Sachs. Go ahead.
Davis Bu – Goldman Sachs
Thank you for taking the call – the question. I guess the question I had was if you could add any more color on the impact on the economy on sales.
I know that you talked about some of the ADAP purchasing habits, for instance, but maybe is there any pressure on the ADAPs themselves? Are you seeing more demand for your own safety net programs and – what’s going on now internationally–?
Kevin Young
Hi, Davis, I’ll just comment on our patient – so–called patient assistance programs, safety net as you referred to. We have not seen any creep–up in our HIV products over the last five quarters in terms of demand from patients who have been unable to get drug by other insurance or other federal means.
So we have not seen an increase in Atripla and Truvada. The only increase in our patient assistance programs we have seen recently is actually Viread and that’s for the Hepatitis B patients.
There are some very small ADAP waiting lists out there in about six states currently, but they are in states where there is a very low prevalence of HIV. For example, Montana, Idaho, so these are very small states in terms of the big picture of HIV.
John Milligan
And Davis, I just want to mention – you asked about the ADAP program and the economy in general. So I mean clearly, we don't think that the economy is having much, if any, of an impact on our business as Kevin mentioned.
With regard to the AIDS drug assistance program, actually there has been good progress within Congress, particularly the Senate with the Ryan White Treatment Extension Act. The Senate passed that bill last night.
It’s now going to the House and it is expected to be voted on perhaps tomorrow by the House. And so that’s an important – it’s an important extension of the funding, which would occur for an additional four years or through 2013 with a – providing an across the board 5% increase in funding.
So we think this is a very positive movement for that Treatment Act. And importantly in this Act, there is also a provision for increased testing where at the federal level there will be a mandate to test five million people per year, so in addition to what states and localities are doing.
So we think that will be an important way to test and then link people to care within the provisions for the new Ryan White Treatment Extension Act.
Davis Bu – Goldman Sachs
Okay, thank you.
Operator
Our next question comes from the line of Phil Nadeau with Cowen & Company. Go ahead.
Phil Nadeau – Cowen & Company
Good afternoon and thanks for taking my question. There is some discussion among investors this afternoon about a “Dear doctor” letter that was set out in the GS 9350 Phase II trials.
Could you confirm whether that was true and disclose what was in the letter and discuss if there is any impact to you, the timelines for either 9350 or the quad combo pill?
Norbert Bischofberger
Yes, Hi Phil, it’s Norber. News travels fast I guess.
So first of all, I want to make sure you understand it’s not the “Dear doctor” letter, it was simply a letter to investigators. And so what this relates to is the solubility of 9350 is very pH dependent.
As the pH rises, the solubility goes down. And so when we reviewed these data few months ago, we made the decision that we are going to do a drug interaction study of looking at the effect of administering GS 9350 together with, for instance proton-pump inhibitors to make sure that, first of all, there is not an interaction and, second, and even more importantly, that whatever little interaction there might be, that it doesn't lead to different boosting profiles of 9350 to Elvitegravir.
Meanwhile, in order to be super–conservative, we have written a letter to investigators and asked them to separate the administration of 9350 from antacids or proton-pump inhibitors or whatever other things that would change – increase the pH of the stomach. But having that said, I am very confident that this is not an issue and also I wanted to tell you that the DSMB recently met, actually a few weeks ago, reviewed safety and efficacy data and they came to the conclusion that the study is on track and should continue.
Phil Nadeau – Cowen & Company
Okay. Just – there was no actual interaction between PPIs and 9350s.
You’ve done this kind of proactively?
Norbert Bischofberger
No. So the only – Phil, the only thing that this relates to, this is a reaction to in vitro dissolution data.
We – other than that, we don't have any other information.
Phil Nadeau – Cowen & Company
Okay.
Norbert Bischofberger
But we are doing – we are currently doing a study to look at the effect of GS 9350 boosted-Elvitegravir with or without proton-pump inhibitors to make sure we understand what the increased pH of the stomach, what the effect of that is on our quad.
Phil Nadeau – Cowen & Company
Okay. Great.
Thank you.
Operator
Our next question comes from the line of Tom Russo with Baird. Go ahead.
Tom Russo – Baird
Good afternoon. I don't think anybody has asked about Tamiflu yet.
Roche and Glaxo for that matter have sounded as if they expect the swine flu sales to be maybe maintainable at a new higher level at least for the mid term and I know you don't control those revenues, but are seeing a nice benefit. So I’d just be interested if you have any thoughts you’d share on the sustainability, let’s say, over the mid term.
John Milligan
You know, Tom, I think we have to leave that all to Roche because they have the greatest visibility on what’s going to happen with Tamiflu, especially in the consumer market outside of the pandemic planning. I am pleased with the effort that Roche has been putting forth and the new team is working on Tamiflu.
So I hope that you are right and this is sustainable, but it’s not something that we have as much visibility as we would typically have with our other products. So I can’t comment further.
Tom Russo – Baird
Okay. Thanks.
Operator
Our next question comes from the line of Jim Birchenough with Barclays Capital. Go ahead.
Jim Birchenough – Barclays Capital
Yes, hi guys. Just a bit more follow–up on the HCV program.
I just want to understand the decision to de–prioritize development with peg-ribavirin. That’s not driven by any negative data in that combination.
I’m trying to understand why wouldn't you do – take both tasks, do combination with the existing standard of care as well as with other direct antivirals. I’m wondering why you are going so forcefully in one direction.
And then I’m also a little confused on – what does a registration program look like for two investigational drugs to try and get a combo approved?
Norbert Bischofberger
Yes, Jim, thanks for the question. So I just want to make clear, we didn’t de–prioritize the 9190 peg-riba program.
We simply decided instead of super–accelerating it and going into a Phase III study right now without any SVR data, and, by the way, there is not only is there no precedent for this from a regulatory point of view, but the FDA has repeatedly stated that they want SVR data to – for – from the Phase II study to initiate Phase III. So instead of spending the money there, we would focus on looking at 9190 in combination with 9256.
So you are absolutely correct, we are actually doing both. We are simply – 9190 with peg-riba is on its merry way, we are waiting for the SVR data and then make a decision based on that whether we are going to put it into a Phase III program, but in parallel, in addition, we are looking at 9190 and 9256.
So, Jim, just one other comment on the development of two experimental agents. Of course, at one point along the way you have to show the contribution of each individual agent and prove that the two together are better than either one alone and that – it still needs to be a discussion with regulatory agencies, but we are thinking given the nature of HCV that it’s a viral disease, there is a lot of precedent from HIV that that could be potentially something you could do in Phase II rather than in Phase III.
So that’s kind of our thinking. But again, it has to evolve and we have not had a conversation with regulatory authorities about this.
John Milligan
Jim, there is plenty of precedents to this in HIV. In fact, Elvitegravir has two experimental agents in it.
So it is something that the antiviral division is used to dealing with.
Jim Birchenough – Barclays Capital
Great. Thanks, guys.
Operator
Our next question comes from the line of Bret Holley with Oppenheimer. Go ahead.
Bret Holley – Oppenheimer
Yes, thanks for taking the question. I’m wondering what might be the earliest timeline for having combo data in HCV and how you might communicate it to us.
I understand the competitive nature. I’m just wondering when we might see the first data for 9256.
Norbert Bischofberger
Well, Bret, I don't want to give you a specific answer. So we are currently doing the drug interaction study between the two agents and based on the results of that we would then move into a combination study.
The reason why I’m a little bit evasive on this is because there is some conflicting information from various geographies including EMEA – a guidance document recently about the need for combination tox studies and depending on what the regulatory authorities ultimately decide is needed to go into a combination study will in part determine our timing. There was a guidance document recently by EMEA and they said they needed three months of combination tox data and that would of course mean it would be – the initiation of that study would be delayed.
As we have more clarity on this and as things move along, we’ll keep you informed.
Operator
Ladies and gentlemen, we have time for one more question. Our last question comes from the line of John Sonnier with William Blair.
Go ahead.
John Sonnier – William Blair
Thanks for taking the question. It’s actually for Kevin.
You mentioned screening initiatives and guideline changes for earlier starts. Another source of growth for you, it’s been a back of your switches and it felt like at ICAAC this year there was maybe less consensus around the cardiovascular risk than the year prior.
Can you just comment on that and whether or not you’ve seen a change in the rate of switching?
Kevin Young
Currently, out there in the U.S., John, in the – in Q2, there was about 63,000 Epzicom patients. So there is still quite a number.
We still, from a promotional point of view, are raising cardiovascular risk and the patients that the physician is tackling in terms of HIV therapy. So it’s still there as part of our interaction with the physician and it's certainly part of our medical education programs.
Also I think – I still think there is going to be studies that emerge and databases that emerge going forward. So we’ll have to see what happens later this year at the EACS meeting or going into CROI, et cetera.
So I think people still continue to look at their databases from the point of view of cardiovascular risk. But it’s something that – it’s part of our discussions and with such a low level of Epzicom use in the naïve patient, I think you can see that whether it’d be Atripla or Truvada, the choice is very much with the Gilead products.
John Sonnier – William Blair
Thanks.
Operator
Miss Hubbard, at this point, we have run out of time for additional questions.
Susan Hubbard
Thank you, Melanie and thanks everyone for joining us today. We appreciate your continued interest in Gilead and we certainly recognize that we couldn’t get everybody’s questions on today’s call.
So we’ll all be back in our offices shortly and happy to address any further questions. Thanks.
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.