Ladies and gentlemen, thank you for standing by, and welcome to the Gilead Sciences Third Quarter 2018 Earnings Conference Call. My name is Sherry and I will be your conference operator today. At this time, all participants are in a listen only mode. And as a reminder, this conference call is being recorded. I would now like to turn the call over to Sung Lee, Vice President of Investor Relations.
Please go ahead.
Thank you, Sherry, and good afternoon, everyone. Just after market closed today, we issued a press release with earnings results for the third quarter 2018. The press release and detailed slides are available on the Investor Relations section of the Gilead website. The speakers on today's call will be Robin Washington, Executive Vice President And Chief Financial Officer Laura Hamilton, Executive Vice President, Worldwide Commercial Operations John McCutchessen, Chief Scientific Officer And Head of Research And Development and John Milligan, President and Chief Executive Officer. Before we begin with our prepared comments, let me remind you that we will be making forward looking statements including plans and expectations with respective products, product candidates, financial projections, and the use of capital, all of which involve certain assumptions risks and uncertainties that are beyond our control and could cause actual results to differ materially from these statements.
A description of these risks can be found in our latest SEC disclosure documents and recent press releases. In addition, Gilead does not undertake any obligation to update any forward looking statements made during this call. Non GAAP financial measures will be used to help you understand the company's underlying business performance. The GAAP to non GAAP reconciliations are provided in the earnings press release as well as on the Gilead website. I will now turn the call over to Robin.
Thank you, Sung, and good afternoon, everyone. We are pleased to share our financial results for the third quarter of 2018. Before I get into the financial results and commercial highlights for the quarter, I'd like to welcome Laurel Hamill, who recently joined Gilead as Executive Vice President, Worldwide Commercial Operations. We're glad to have this key position filled and are excited to have Laura on our team. Laura is quickly becoming familiar with our business and has already provided significant commercial expertise on several strategic fronts.
You'll hear from Laura in a few minutes followed by John McHutchison with an update on our R and D efforts and then John Milligan with a few closing comments. We had very strong execution in the third quarter during which our HIV franchise achieved record quarterly sales. HCV revenues continued to be more predictable and in line with our expectations and further progress was made in cell therapy. Including the approval of Yescarta in Europe. Total revenues for the third quarter were 5,600,000,000 with non GAAP diluted earnings per share of $1.84.
This compares to total revenues of 6,500,000,000 and non GAAP diluted earnings per share of $2.27 for the same period last year. Starting with HIV. Product sales for the 3rd quarter were $3,700,000,000, up 12% year over year, and 2% sequentially. The year over year increase was primarily due to the continued strong uptake Anodepsi and the rapid adoption of Biktarvy. With 19% year over year revenue growth, and 11% year over year prescription growth, our U.
S. HIV business continues to reflect strong underlying demand for Descovy based regimens, which now account for 74% of Gilead's total U. S. HIV prescription volume. Sequentially, U.
S. HIV sales were up 5%, reflecting strong demand for Biktarvy. Payer mix in the 3rd quarter was similar to the 2nd quarter, where it was approximately equally split between private pay and government segments. In the 2nd full quarter, since its FDA approval in February, biktarvy generated $375,000,000 in sales in the U. S, becoming the number one prescribed regimen for both treatment naive and switch patients.
Biktarvy is on track to overtake Genvoya as the most successful launch in HIV history. As measured by the 1st 12 months of product sales. Approximately 85% of Biktarvy's US prescriptions came from switches. Of these switches, approximately 1 quarter came from regiments containing dolutegravir. Truvada for Prep continued to grow.
We estimate that more than 193,000 individuals were taking Truvada for Prep as we exited the quarter. Early performance indicators for the HIV prevention and Truvada for Prep Television Campaigns launched in the second quarter are encouraging. Since the launch of these campaigns, we've seen active engagement with campaign related websites and a nearly 50% increase in the number of weekly new subscribers compared to the pre campaign averages primarily due to which now comprise approximately 70 As anticipated, we saw a sequential decline in certain countries and the seasonal impact of holiday schedules in various countries. To date, in some countries, the impact from generics has not been as significant as expected. Since receiving marketing authorization from the Your Commission in June, Biktarvy has launched in Germany and some of the smaller countries in the EU.
In Germany, we are seeing great early uptake where Biktarvy is tracking at least as well as Genvoya for the same period after approval. Also, biktarvy is already among the top 5 most prescribed regimens for both treatment naive and switch patients. With about a third of the switches coming from dolutegravir containing regimens. Genvoya remained the number one prescribed regimen for treatment naive and switch patients in the EU5 collectively for the 6th consecutive quarter. Turning to HIV.
Product sales for the 3rd quarter were $902,000,000, down 59% year over year, and down 10% sequentially. To date, our performance in the HCV market continued to align with our expectations of gradual sequential declines with fewer patients seeking treatment. In September, we announced plans to launch authorized generic versions of Atclusa and Harvoni in the United States in January 2019 through a newly created subsidiary of Segua Therapeutics LLC. The list prices of the authorized generics will be comparable to the current net increased pricing transparency and open up access to our HCV medicines for patients covered by Medicaid. This solution allows us to quickly introduce a lower priced alternative to our HCD medications without significant disruption to the healthcare system or our business.
Turning to our cell therapy franchise. Sales of Yescarta were $75,000,000 progress we've made with Yescarta since its approval by the U. S. FDA 1 year ago. We now have 64 centers certified to provide treatment for Yescarta.
As we continue to we have also observed variability in volume, as some centers enthusiastically embrace this novel therapy and others adopt treatment more slowly. We've turned our focus to working with centers to enhance patient flows. We are also educating community oncologists about cell therapy and how they can connect
We expect to see continued
become increasingly aware of this life saving therapy. Recently, CMS approved an NTAP new technology add on payment to assist the reimbursement of CAR T therapy within the hospital setting while we await speed in which CMS has recognized the value of Yescarta for cancer patients who have run out of treatment options in relapsedrefractory DLBCL. We look forward to working with CMS to create a dedicated DRG code reflective of the value as part of brings to patients. As I previously mentioned, Yescarta was approved in the EU toward the end of August. We are working diligently across Europe to certify approximately 20 seen to date with Yescarta, which is consistent with our expectations.
Going forward, we anticipate a study and measured launch as reimbursement, referrals, and central logistics improve to accommodate more patients. Turning to our cardiovascular products, Lateris and Ranexa generated sales of 241,000,000 and $178,000,000, respectively, in the third quarter. While the U. S. Patent for Ambras fired in July of this year, we have not seen any impact to our sales as a result of the loss of exclusivity.
Because the single shared REMS program necessary to allow generic Ambrascent into launch has not yet been FDA approved. There is no specific PDUFA date associated with this approval, and the timeline for FDA action is unknown. As we look ahead, we anticipate Laterra sales to continue for the remainder of this year. However, sales beyond this timeframe are uncertain. Now turning to expenses.
Non GAAP R and D expenses were 844,000,000 for the third quarter up 13% compared to the same period last year. Non GAAP SG and A expenses were $852,000,000 for the third quarter, up 6% compared to the same period last year. The increases in both non GAAP R and D expenses and SG and A expenses were primarily due to higher costs to support the growth effective tax rate in the third quarter was 19.9% compared to 25.7% in the same period last year. Primarily due to reduction of Our non GAAP effective tax rate was higher compared to the second quarter rate of 13.4 percent due to a favorable settlement of a tax examination in the second quarter. Moving to our balance sheet.
As of September 30, 2018, we had $30,800,000,000 of cash and investments. During the third quarter, we generated $2,200,000,000 in operating cash flow. Repaid 1,800,000,000 senior notes upon maturity, paid cash dividends of 742,000,000 and repurchased approximately 6,000,000 shares of stock for 449,000,000. The year is progressing consistent with our expectations. With the exception of the durability of Latera's revenues, and the lower impact of HIV generics.
The combined benefit from these 2 exceptions is approximately $400,000,000. Therefore, we are raising our to $213,000,000,000. Our guidance is subject to a number of uncertainties, which are outlined in Slide 35, of our earnings call presentation. Of 18% to 20%. All other components of our guidance remain unchanged.
I will now turn the call over to Laura
Thank you, Robin, and good afternoon. I'm thrilled to be part of the Gilead team and appreciate how welcoming everyone has been during my 1st 6 weeks as I'm getting to know the critical success factors for our current and future therapies. I've had the opportunity to learn more about Gilead portfolio by participating in several therapeutic advisor board meetings, scientific conferences, visiting some of our cancer institutions that are providing treatments with Yescarta and engaging with many passionate Gilead employees. The commercial and field teams have a deep commitment to support healthcare providers as they meet the needs of patients around the world. It's a privilege to be joining Gilead at this time with the introduction of Yescarta as well as Biktarvy, which is on track for an outstanding launch we are continuing to shift treatment paradigms.
I also wanna acknowledge the innovative approach the team has taken in the United States to increase access to our hepatitis C treatments. Next year, our subsidiary, Asegua, will launch authorized generic versions of Harbony and Aclusia, a medication we believe, has a unique clinical profile at the Penn, genotypic and pin fibrotic single tablet regimen. As we prepare for our next set of launches, we will bring our deep expertise in building new markets as well as capabilities to compete in existing markets with many therapeutic options The teams around the world are motivated by Gilead's mission to bring innovative medicines to more than 13 million patients with life threatening illnesses. I look forward to sharing our commercial
Thank you, Laura. Welcome, and thank you everybody for joining us today. I'd like to start by talking about the progress we anticipate readouts from 5 Phase III studies over the next 9 months. The American College of Rumohr I'll begin with some commentary about our work in the area of inflammation starting with Filgotinib, which, as you know, is the selective JAK1 inhibitor. Last month, we announced positive results from FINCH 2, the first of 3 Phase III studies to read out in patients with rheumatoid arthritis.
FINCH 2 compared Filgotinib to Placebo each added to conventional disease modifying anti rheumatic drugs or demabs in 420 3 patients who have previously not had an adequate response to biologic therapies. Filgotinib was generally well tolerated and met the study's primary endpoint in terms of the proportion of patients achieving an ACR 20 at week 12. In addition, key secondary endpoints including ACR50 and 17 responses and the rates of low disease activity and clinical remission were all higher with Filgotinib compared to Placebo. Importantly, for these endpoints, we also noted a dose dependency as efficacy rates were numerically higher with the 200 milligram once daily dose of filgotinib compared to the 100 milligram daily dose. The initial readout of the first Phase III data adds to our excitement about the potential of Filgotinib, obviously.
We expect results from 2 other Phase III studies of Filgotinib, FINCH 1 and FINCH 3 to be available in the first quarter of next year. And is supported by the data to form the basis of our filings for regulatory approvals globally. As a reminder, FINCH 1 is a 52 week randomized study comparing both doses of Filgotinib plus methotrexate to adalimumab plus methotrexate and to methotrexate alone, in patients who have previously had an inadequate response from these at Trexact. FINCH 3 a 52 week randomized study comparing filgotinib alone to methotrexate alone and to the combination of filgotinib plus methotrexate in methotrexate naive patients. Now our ability to file the NDA for Filgotinib is dependent on data from the MANTA study.
As you may recall, MANTA is a safety study in men with ulcerative Kolysis that was requested by the FDA and is designed to address non clinical findings observed in preclinical animal studies. Because our phase 3 FINCH trials have enrolled more rapidly than anticipated, enrollment in MANTA will likely be the rate limiting factor to filing an NDA in the United States. While we have been making every effort to expedite enrollment, the full impact of the efforts and their impact on the overall timeline are uncertain at this time. Results from an equate from the Aquata study, a Phase 2 trial of filgotinib, in 131 adults with active psoriatic arthritis were presented this week at ACR in a plenary session and concurrently published in the Lancet. The study also achieved its primary endpoint of improvement in the signs and symptoms of psoriatic arthritis at week 16.
The study demonstrated an impressive ACR 20 response of 80% for Filgotinib 200 milligrams daily, versus 33% for placebo. The ACR50 and ACR70 responses were also significantly higher for filgotinib compared to Placebo. Based upon the strength of these data, We're excited to be initiating plans for our Phase III program and are enthusiastic about what this may mean for people living with psoriatic arthritis and whose disease is not responded to prior treatment. Last month, we announced that Filgotinib met its primary efficacy endpoint in the Phase II Tortuica study in adults with moderately to severely active ankylosing spondylosis. Patients treated with Filgotinib achieved significantly greater improvements in the ankylosing spondylitis Disease Activity Score at week 12 compared to Placebo.
These results, which were also published in the lands this week, compare favorably to those seen with other known demer commonly used to treat ankylosing spondylosis patients. Will determine the next steps for the program in the coming months. Finally in the inflammation therapeutic area, I'm pleased to share that a Phase 2 study evaluating 3 investigational therapies: Filgotinib, G S9876 a second inhibitor, enterobrutinib, a BTK inhibitor in patients with active sjogren syndrome has fully enrolled 140 patients. Now turning to HIV. We presented 96 week data at ID Week in San Francisco earlier this month from an ongoing Phase III study evaluating the safety and efficacy of Biktarvy for the treatment of HIV infection in treatment naive adults.
The data 2 years confirmed the efficacy and safety profile of Biktarvy and showed that Biktarvy continued to be well tolerated with no cases of treatment emergent resistance. Moving onto liver diseases, The Liver Meeting will be held in San Francisco early next month, where we will present data for more than 50 abstracts across our programs in NASH primary sclerosing cholangitis, hepatitis B and hepatitis C. In NASH, We are advancing multiple investigational compounds for the treatment of advanced fibrosis that is patients with stage 3 and stage 4 fibrosis. Indivables with these advanced stages of fibrosis are at a significantly higher risk of liver related mortality. The data being presented further characterized the potential role of 3 compounds we have in development.
Our FXR agonist, TS9674, our ASK-one inhibitor, Soloncitive, and our ACC inhibitor GS0976. We will also present baseline data from STELLAR3 and STELLAR4, our 2 ongoing Phase III trials evaluating selonsertib as monotherapy that describe the potential role and sequence of non invasive tests and their ability rosis poses challenges to timely and efficient diagnosis and treatment of patients with this disease. Before we move on from NASH, I'd like to remind you that we anticipate data readout from STELLAR3 and STELLAR-four in the first half of twenty nineteen. We are also pleased to share that the Phase 2b at the study of various combination 2 drug regimens in patients with NASH and advanced fibrosis has now closed screening. We are presenting data from a phase 2 trial evaluating our FXR agonist in primary sclerosing cholangitis.
This is a rare serious disease that causes progressive inflammation and scarring of the bile ducts. Which can lead to cirrhosis and its complications, including liver failure. There are currently no effective treatment options available for these patients. And finally at the Liver Meeting, we will also share data from Gilead's on growing programs directed at achieving functional cure of chronic hepatitis B infected patients. GS9688, an investigational oral selective colleague receptor 8 agonist is the subject of several studies to be presented, including the first in human, and Phase 1b results evaluating the drug in patients with chronic hepatitis B.
Turning to cell therapy. We continue to make great scientific progress also during the quarter. In August, we announced that European Commission granted marketing authorization for Yescarta is a treatment for adult patients with relapsed or refractory diffuse large B cell lymphoma and primary mediastinal large B cell lymphoma up to 2 or more lines of systemic therapy. We are making progress in reaching patients with other forms of B cell malignancies also with Yescarta and KITE X19. Registrational phase 2 trials are ongoing with Yescarta in relapsed and refractory indolent NHL non Hodgkin's lymphoma and with KITE X19 in relapsed and refractory mantle cell lymphoma and adult ALL.
We expect to announce initial data and trial updates from our cell therapy program at the American Society of Hematology Annual Meeting ASH, which begins December 1st in San Diego. We will share more information with you next month when those meeting abstracts are published. Separately, in oncology, we discontinued the development of and decalixibant an investigational anti MMP9 antibody in gastric cancer after a phase 3 study showed a lack of overall survival benefit the primary endpoint. These data are consistent with the results we're seeing with and decoliximab and other therapeutic program. We continue to pursue additional technologies and approaches that will allow us to remain the leader in cell therapy.
Earlier this month, we announced another research collaboration and license agreement with Highfive Biotherapeutics, to develop technology supporting the discovery of neoantigen reactive T cell receptors for the potential treatment of various cancers particularly solid tumors. Through this collaboration, we intend to adapt hypoBio's proprietary single cell technology platform to create a high throughput approach that will potentially allow for in-depth screening of TCR repertoires from patient samples to identify both shared antigen and neoantigen TCRs for use and adoptive T cell therapies. Neoadigens arise from tumor specific mutations that are unique to each patient's cancer, offering the potential for more targeted anti tumor activity. This area of research has the potential to transform the way we might be able to treat many solid tumors. I would like to also note that these kinds of scientific collaborations are not limited to cell therapy.
In September, we entered into a strategic collaboration with precision biosciences to develop therapies targeting the in vivo elimination of HBV or hepatitis B virus, the Precision's proprietary genome editing platform, ARcus. We are committed to developing therapies to achieve a functional cure for patients with chronic hepatitis B virus. We're excited about the potential of genome editing and Precision's ARCUS Technology, which has already demonstrated promising in vitro activity. We have achieved a great deal across our R&D organization this quarter, and I am confident we will continue to make significant progress throughout the rest of the the breakthrough work we are doing in cell therapy and the cutting edge research we are doing to advance purity therapies, both for hepatitis D and HIV infected patients. I want to take the opportunity to thank hard work and execution.
So thank you all. And now I'd like to turn the call over to John Milligan.
Thank you, John. Good afternoon, everyone. As we approach the end of the year and head into 2019, we have many reasons to feel confident about the strength of our business the future of our company. Our long term leadership in HIV continues. We're having a terrific launch with Xiktarvy, which is exceeding our high expectations and is on track to become the most successful ever in HIV through the 1st year of sales.
We also have compelling evidence Correlating the use of Truvada for PrEP, with declines in new infections in the United States, further demonstrating its importance as an effective public health intervention and the ongoing efforts to meaningfully decrease new infections. While great progress has been made, in both treatment and prevention over the last 2 decades, we believe there's still plenty of room for innovation and HIV. We're pursuing research that could help patients who have run out of options as a result of viral resistance or who may need less frequent dose than afforded by a daily pill. And finally, we hope that our research may one day help lead to a cure, completely removing the virus from patients once and for all, as we did support efforts toward elimination of the virus from the human population. In January, just over 5 years after the launch of Savalde our newly formed subsidiary, Asegua, will launch authorized generic versions of Aclusa and Harvoni in the United States.
We believe this will help reduce out of pocket expenses for many patients, increase price transparency, and open up access to our HCU medicines for patients covered by Medicaid with Gillette is the leader in cell therapy and yescarta access for people with relapsed refractory DLBCL is now established in over 60 centers in the United States. Itscarta has shown an unprecedented duration of response in clinical studies, and we have now treated nearly 700 patients across clinical trials and commercial use. The high percentage of patients showing a durable response following the single cellular fusion gives us a glimpse into the potential of cellular therapy to radically change the cancer treatment paradigm in the future perhaps across many different tumor types. Over the last year, we've established 6 technology product based partnerships that will allow us to build on our leadership position in cell therapy and transform the treatment of cancer. We have a maturing pipeline and are now beginning to see the first of many Phase III readouts filgotinib and inflammation.
We are pleased that the efficacy and safety of Filgotinib looks to be consistent with the data sets from the long term phase 2 studies and believe Filgotinib shows great promise to help patients in a number of different indications. Finally, Gilead has dedicated enormous resources to understand the biology and pathology of NASH. These efforts are paying off with 3 compounds in the clinic, including an extensive array of phase 2 combination studies Next year, we'll see the 1st Phase III readouts of Soloncertib as the SOLAR3 and SOLAR4 clinical studies are completed and blinded. We look forward to seeing The work of Gillette Gildan, even as I prepared to depart at the end of the year. To everyone who supported us in our mission over the years, Thank you.
I have every confidence in my team's ability to continue To go ahead, more than 11,000 employees, I also want to thank you. It's been a privilege. To be your leader for the last 3 years and to work with you for the last 29s. It's been deeply gratifying to be part of a company that has brought lifesaving treatments to ten million people around the globe. I look forward to watching the continued evolution of Gilead and the extraordinary things I know you will accomplish.
So let's open it up for questions.
We will you. Our first question comes from Geoff Meacham with Barclays.
Good afternoon, everyone. Thanks for the question. John, really will miss your leadership and I want to add congrats also to Lara on the new role. Just had a few on HIV. If you guys could give us any more perspective on switches to Viktarvy beyond Delta Dolutegravir, are you guys seeing switches from generic regimens as well.
And then on prep, I know you don't have data yet, but what's the initial thought on positioning for Descovy over Truvada? And how do you think that plays out following the Truvada LOE? Thank you.
So in terms of switches, Jeff, as
I mentioned, we are seeing that the majority of the Biktarvy prescriptions are coming from switches, about 85% to be exact. And approximately a quarter of those are coming from dolutegravir containing regimens. There's also about 25% coming from Genvoya as well. So there's good overall balance. And then the latter half of
your question, Geoff, if you can repeat it? SCovy.
Descovy for PrEP?
Oh, it's going for PrEP. Sorry, that's John.
Yes, John here. Look, the question of Descovy versus Truvada for prep, people who are healthy, which the people who are taking prep are, deserve and want the easiest and safest and best tolerated medication. So that is Descovy. So I think that's a pretty straightforward answer to that question.
Thank you. Our next question comes from Brian Abrahams with RBC Capital Markets.
Hey guys, thanks very much for taking my question and congrats on the quarter. On Filgotinib, with the phase 3 starting to roll out, I was wondering if you could provide your latest views on what you see as the key differentiating features or indications? And maybe walk us through your latest plans in how you're thinking about building out a commercial infrastructure and inflammation, particularly with some of the new leadership now in place? Thanks.
So I'll start first. So after attending ACR this week, And being at the meeting, it's clear that the efficacy that we are generating in multiple inflammatory diseases with Filgotinib is as good or if not better than any other drug in the class and equivalent to the biologics. And that holds true for FINCH 2 where we just saw the most difficult patients to treat biologic non responders inadequate responder patients. Where our ACR 20 rates in people who'd received 3 or more biologics previously was over 70%, just over 70%. So I think efficacy wise, we are as good, if not better than anything else out there in the class.
Safety wise, we continue to see the differentiation based upon the lab parameters, the anemia, the lack of anemia, the lack of effect on platelets. And when we look at other clinical events such as thrombo embolic events, and other events, we're not seeing any difference. We have to see that safety, benefit and advantage hold up in the subsequent Phase III clinical programs. The same with the other diseases we're seeing those benefits as well. So I'll hand it over to the other folks about the commercial build out, etcetera.
So, hi, this is Laura. I would say in the commercial structure, we will build a commercial field team that is competitive across all indications. And as you know, we are aware of the investment that's necessary to compete in this market and we will be reaching consumers in innovative ways to make sure that they are, aware of the profile that we'll be able to bring to the market to help them.
Our next question comes from Michael Yee with Jefferies.
Thanks. I appreciate the question. And, John, I'm sure we all heard the emotion in the voice. So We appreciate all the work you've done and for all the years. I guess, my question is, it feels like the street has 2 uncertainties.
1 is a bit on Pepsi and 1 is, I guess, to an extent, an update on the new leadership would give people confidence going forward. Perhaps you can give a comment as to your confidence around the U. S. Hep C market stabilizing, whether there's any changes and how authorized generic helps that, if at all? And then if you can make a comment on where we stand on the leadership change, I think that would help people as well.
Thanks.
Hi, Michael. So let's just talking about the U. S. Hep C market. What we have seen through the course of the year is a fairly stable pricing environment.
But of course, declining patient numbers, particularly in the commercial markets, and to some extent, the Medicare markets So we think the authorized generic will actually boost us for the future because number 1, it provides more transparency, which is good for everybody. It will take away some of the pain of the co pays that are provided, especially into the Medicare population. But most importantly, it'll open up access for us into the Medicaid population, which is the largest growing segment of patient for the future. And so we think that all this will enhance our ability to compete for the future and really help stabilize this market going into 2019 and beyond. So all in all a very positive thing for us.
With regard to the CEO search, I really can't say anything specific other than to say that our many candidates who are very interested. The process is moving along quickly. And we certainly hope to have somebody announced, before the end of the year.
Our next question comes from Matthew Harrison with Morgan Stanley.
Great. Good afternoon. Thanks for taking the question. I have one related to some of the Kite programs. I noticed in the slides you indicated that you'd be making a decision on your BCMA car to whether to move into a registrational study in the fourth quarter.
I'm just wondering what data you're waiting to make that decision and how you're going to communicate that decision? Thanks.
Look, yes, it's unchanged. We are waiting for data from the phase 1b trial, which is looking at escalating dose cohort the safety and efficacy in myeloma patients at 585. And then we'll announce the site of a phase 2 trial if the data supports that. So no change to what we've said previously, and we're in the process of that right now.
Thank you. Our next question comes from Geoffrey Porges with Leerink.
Thank you very much. And John, I just want to congratulate you on all the accomplishments over those 29 years. I'm sure if you have any free time, John McHutchison might lend you his AO for a bit of travel. I just wanted to ask John McHutchison a little bit about a couple of pipeline contingencies. First, you mentioned the NANTO study.
And obviously you'll have the 3 FINCH studies by the in the first half of the year. Is it possible that that filing could be delayed until 2020, or is there any way you could start filing with the clinical data and then pinned the Nanta data to the filing? And then secondly, will you have a chance to look at the interim data from the combination NASH study and then potentially contemplate, pivotal trials to some combination earlier than the 48 week data?
Thank you, Jeff. Starting with MANTA. Great question. We have spent an unaudited amount of effort trying to enhance the enrollment in the MANTA study. It's too early to gauge the effectiveness of those modifications to inclusion criteria, etcetera.
I think we'll provide an update in the future when we can have more clarity about the timelines. I will say we are having discussions internally and with regulators about different options as one of which you outlined as well. And as you know, in various parts of the world, you can file and you can file updates at various different times of the review process. So each region and each area is different. So we're having all of these discussions and spending a lot of my effort and a lot of the team's effort on that as well.
In terms of the Atlas, the second question, in terms of the Atlas, Phase 2b 350 patient NASH combination study, yes, we will take a look at week 24, Now week 24 look, we're allowed to do in the statistical analysis plan. It's not biopsy driven, but it's driven by, MRE, FibroScan, lab tests, MRI PDFS. So we will be able to have a look And if there's clear separation without biopsy, we can decide to move earlier to phase 3 if we're convinced that's the right thing to do.
Thank you. Our next question comes from Robin Karnauskas with Citi.
Hi, this is Greg Harrison on for Robin. Thank you for taking the question. So in hep B, Given the Arrowhead data we've seen recently, do you think that you need an S antigen component in your combos or are you satisfied with what you have internally?
I don't think we're ever satisfied with what we have internally. And we have a number of internal programs that are looking at interfering it as in various different ways. Either by direct mechanisms or through induction of HBV specific immunity. And we are also always looking for what we think is additionally valuable to what we're doing internally, externally as well. We are watching the siRNA fields closely also and aware of what Arrowhead has done.
We look forward to seeing the data presented in full at AASLD.
Thank you. Our next question comes from Umer Raffat with Evercore.
And all yours and Gilead success over the years. My question was perhaps twofold. 1, going forward for the new CEO, is there specific expectations that the board has set? May that be on specific M and A targets, dollar size number transactions. I just wanted to get a flavor for the direction for the company and board's expectations.
And then secondly, on CAR T, We heard your commentary on the variability in adoption. And my question is, Street has a 50% growth or the next four quarters for Yescarta franchise. And given how important to launch it is, my question is, do you remain confident in that type of growth trajectory?
So, first, let me start with the specific criteria for a new CO9. That's not typically how things are done. There is, there are conversations and, looking at different strategies that a new CEO could bring to Gilead, but there are no specific targets or directions that were given by the board. So secondly, and question about CAR T is a good one. So if you think about CAR T and you think about that the shift in paradigm that has to occur in a treatment center to adopt it.
It requires lots of collaboration across multiple departments It requires novel ways of thinking about billing and treating patients. And it takes time for these centers to come up to speed. The centers that were early adopters of CAR T and are still the biggest users of Yescarta, have a lot of experience in kind of worked out the treatment and frankly business paradigm of cellular therapy. And that's where we're seeing the majority of our success to date. The middle adopters and now the late adopters are the groups are really trying to figure out how to make this work within their institution.
And how to make this business model work for their hospital in particular. And that can take some time. So what we would expect is that as these as these centers start to treat as they work out how to build, the commercial plans as they figure out how to get reimbursement through for Medicare patients, this will grow over time. And of course, we'll see some centers that have greater adoption and some that have less. So I do think that with the data that are emerging on CAR T, with the growing body of evidence that a high percentage of patients can have very durable responses.
This is something that will grow to become of importance in all sixty centers that we're in. But it is going to take some time to get the growth rate that we need. I won't comment on these specifics, but I am very confident that as we get better at this, as the medical practice gets better, as we get better at managing some of the side effects around this, and then importantly in the future, as we get a DRG this will grow into a very important business for Gillette, and it will be very, very important for patients who've run out of options.
Thank you. Our next question comes from Alethia Young with Cantor Fitzgerald.
Hey guys, thanks for taking my question. Congrats on Biktarvy and Don. You certainly be missed. And we truly enjoyed seeing observing her leadership over such a long tenure. I guess I have a question on HIV in Generics in Europe.
You said obviously you've seen some impact and there actually have been some countries where you haven't thought you thought you would see impact and didn't. So can you talk a little bit more about Those are in dynamics there. Thanks.
Sure. Alethia, congrats on your new role as well. Yeah, we We continue to see adoption of generics across Europe. I think what we're seeing is differentiation across the different countries relative to timing and the uptake of generics. We talked about the uptake of Descovy.
That continues to go really well. And we think that's thwarting some of that uptake. Particularly in Italy and UK, we're just not seeing the uptake of generics as quickly as we thought they would take hold. And that's something that we factored into our guidance to the tune of $100,000,000. I think even in 2019, we'll continue to see updates of generics, but with the launch of Biktarvy, etcetera, we think we'll be well competitively because shouldn't think all the benefits of Descovy will help us to continue to grow share in our ex U.
S. Market.
Our next question comes from Phil Nadeau with Cowen.
Good afternoon. John, let me add my congratulations on all that you've accomplished and best of luck on your next act. My question is on the guidance. Looks like that even at the top end of the guidance, you're projecting a sequentially down quarter in Q4. Just curious to get a little bit more information on what elements do you think are going to have a quarter over quarter decline?
Is that HTV? Is that EU HIV? Information you could give
us would be appreciated. Thanks.
Sure, Phil. I won't go, again, we kind of gave up base of our guidance. First, let me just say, we're really very satisfied with how the year has gone and the ability to raise guidance at this point. Everything that we've talked about from HIV being a growth franchise to HCB stabilizing, Yescarta continuing to have a nice, slow and steady build. I mean, I think overall, all our franchises are performing very well.
There's a couple of dynamics. You mentioned a few, one HCC, as we said, while stabilizing, we do continue to see declines in patient starts. If that's the primary driver recall, we talked last quarter about a price freeze, for the next 6 months, which if you think about a typical Q4, we sometimes see inventory build, in Q4 in advance of that price increase. And I'm not saying we won't have any inventory build, but some of that's just part of supply chain. But we do anticipate that there may be a little less.
And as I mentioned, the other driver of our raise in guidance was Lateras and the LOE, which is here, we haven't seen any impacts. That could happen, right? So we were providing a range of guidance but we're very confident with our ability to meet the guidance and hope to overachieve it.
Thank you. Our next question comes from Cory Kasimov with JP Morgan.
Hey, good afternoon guys. Thanks for taking my question. Us first to John, congrats again on a really great run. So I guess my question is on biktarvy on the heels of a really impressive quarter for the product. I'm just curious if there was any meaningful contribution from inventory build or any other type of one time item or is this really all just demand driven?
Thanks.
Hi, Cory. Great question. No, our sequential growth was all demand driven. We didn't see really any change in inventory. And as you're probably recalling last quarter, I talked about the fact that we were at a fifty-fifty payer mix between commercial and government.
And there was the chance that that would have shifted back to what we've traditionally seen 45 commercial 55 government, but we didn't see that. And these payer mix percentages do fluctuate quarter to quarter really dependent on the buying patterns from government payers such as ADAP. So overall, a strong demand driven quarter for Biktarvy Again, just, and HIV overall, no impact from inventory or payer mix.
Our next question comes from Terence Flynn with Goldman Sachs.
Hi, thanks for taking the question. Maybe just a couple of follow ups on Biktarvy and the TAF portfolio. First, you just comment on European pricing dynamics for biktarvy now that you're a little bit further in and maybe help us think about that heading into 2019? And then can you guys disclose total TAF volume in Europe right now? I know you give us that for the U.
S, but just wondering where it stands in Europe. Thank you.
Yes. So it's hard to talk about volume because of generics. We do talk about, TAP or Descovy base as a percentage of revenue and it's about 70 percent of revenues in U. S. Pricing really hasn't been a barrier.
Keep in mind we priced our Descovy regimens are pretty much priced, similar to Stride Belt, etcetera, and givuya, Biktarvy. So it's really been good overall uptake. I think we'll always see competitiveness in European pricing but that's something that we're used to. So it really fundamentally has been just the desire for more and more patients to want to move to Descovy based regimen. That has been driving our performance offset by the adoption of generics.
Thank you. Our next question comes from Ying Huang with Bank of America Merrill Lynch.
Thanks for taking my questions and congrats to join as well. So first one on yes, Carter, I think, Robin, you mentioned that now you do have this new technology add on payment. I was wondering how much that helps the adoption for gift card under that. And how much is this financial loss, is actually stopping our centers from adopting I guess color? And then secondly, We noticed that, you have exclusive status with Express Scripts for 2019 and the Madarest from Abby was excluded.
Does that mean there's additional pricing concession or rebate provided by Gilead? Thank you.
So let me start with the prior question. Yeah. I think as always, as our case, we're always working and negotiating with payers. I won't I can't talk specifically to the details of the contract, but we're happy that, we reached the formulary ranking with, Express Scripts and it's something that we've talked all about that we continue to be out there competing in this marketplace. There's that's up in Maverick.
And we continue to do well. I think to your other question relative to Yes, Carta, yeah, the NTAP, as I said, it's a start As we understand it, it's about 50 percent of reimbursement, to tell you what every hospital makes or doesn't make, that's very hard for me to comment on. That's very dependent on their relationship with the payers, etcetera. So I can't give you more details on that. I do think the NTAP is a start and we're working very, very diligently and hard to to show the value of this treatment and hopefully eventually see a DRG specific for CAR T therapy.
And our final question comes from Steven Seedhouse with Raymond James.
Hi, thank you for taking the question. Just on NASH, understanding the hope is obviously that both STELLAR-three and STELLAR-four succeed I'm curious if there's a viable filing strategy or path forward for either monotherapy or combination therapies for selected in basically refined fibrosis subset of NASH patients. If one of those 2 Phase III trial hits the primary endpoint or have you designed the clinical programs such that both Phase III trials need to work to move sponsorship forward? Thank you.
So, it's a good question regarding the seller programs. And I think the answer for your question lies in the Stellar programs where our discussions with regulators were around both trials independently, but I think everybody understands that a third of patients with F3 really have F4 and a third of patients with F4 have F3. So if, for example, there was a situation where one trial was positive and one trial was negative, we would be able to look at different subgroups of patients, but that would be a completely unscripted discussion but would just depend on what the data looks like at that time.
Thank you for participating in today's question and answer session.
Thank you, Sherry, and thank you all for joining us today. We appreciate your continued interest in Gilead and the team here looks forward to providing you with updates on our future progress.
Ladies and gentlemen, thank you for participating in today's conference. This does conclude the program. You may all disconnect and have a wonderful day.