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GlaxoSmithKline plc (GSK) Q1 2019 Earnings Call Transcript

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GlaxoSmithKline plc  (NYSE: GSK)
Q1 2019 Earnings Call
May. 01, 2019, 7:00 a.m. ET

Contents:

  • Prepared Remarks
  • Questions and Answers
  • Call Participants

Prepared Remarks:

Operator

Good afternoon ladies and gentlemen, and welcome to the Analyst Call on the GSK First Quarter 2019 Results. I will now hand you over to Sarah Elton-Farr, Head of Investor Relations, who will introduce today's session.

Sarah Elton-Farr -- Head of Global Investor Relations

Thank you. Good morning and good afternoon. Thank you for joining us for our Q1 2019 results which were issued earlier today. You should have received our press release and can view the presentation on GSK's website. For those not able to view the webcast, slides that accompanies today's call are located on the Investors section of the GSK website.

Before we begin, please refer to slide 2 of our presentation for our cautionary statements. Our speakers today are CEO, Emma Walmsley; Iain Mackay, CFO; Luke Miels, President, Global Pharmaceuticals; and David Redfern, Chief Strategy Officer and Chairman of Viiv. We have a broader team available for Q&A. We request that you ask only a maximum of two questions so that everyone has a chance to participate.

And with that, I will hand the call over to Emma.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Thanks SEF, and hello, everyone. 2019 is an important year of execution for GSK, and I'm pleased we've made good -- we've made good progress this quarter with growth in sales in constant exchange rates across the group and an improved group margin.

Group sales growth of 5% in CER terms reflected an increase in sales in all three of our global businesses, with a particularly strong performance in vaccines. The pharma business continues to shift its portfolio shape well with strong growth from new launches. And although consumer had a slow quarter, we remain confident and excited about the outlook for this business.

Group adjusted operating margin this quarter was up one percentage point on a CER basis. On a total basis, earnings per share were up 42% to GBP0.168, and adjusted earnings per share increased 18% to GBP0.301. Included within operating margin and EPS, there are a number of matters of note that benefited the quarter, and Ian will address these in just a moment. Nonetheless, it's a strong start to the year, and we reaffirm our full-year guidance.

Our free cash flow this quarter was in line with our expectations with GBP165 million, impacted, as you know, by the launch of generic Advair, the phasing of rebates, and higher restructuring charges, all as anticipated.

Two years ago this summer I laid out my long-term priorities for the whole company: innovation, performance, and trust, all to be powered by a necessary culture change. And we've made a strong start to the focused areas for 2019. We've continued to execute on our new product launches, and have demonstrated strong growth with Nucala and Trelegy in respiratory and most notably in vaccines with Shingrix.

Strengthening our pipeline is critical to our long-term success, and we've made good progress here, too. In HIV, we've already had good uptake for the first of our two drug regimens, Juluca, and we're now seeing the next wave of important innovation come through.

Last month we received US approval for the second of our two-drug regimens in HIV for Dovato, and we're delighted to make this new treatment option available to treatment-naive patients. And just earlier this week, we filed for the US approval of the first long-acting injectable HIV treatment, cabotegravir plus rilpivirine, and we're planning for a potential launch in 2020. We're generating data to support three upcoming oncology filings for BCMA in multiple myeloma, for Zejula in the first-line maintenance therapy of ovarian cancer, and for dostarlimab in endometrial cancer. And we were pleased to close the transactions with Merck as well as Tesaro further strengthening our growing oncology pipeline.

In performance, we've continued to drive growth in sales and improvements in our profitability, and we've been working hard on the creation of the Consumer Health joint venture with Pfizer, and expect this transaction to close in the second half of the year. Integration planning is well under way, and we've recently announced the new leadership team for the JV, bringing key talent from both companies into the joint venture, including Brian's counterpart, Chris Slager, the President of Pfizer Consumer Healthcare, who'll be leading our new combined Americas business.

And lastly on trust, we want GSK to continue to lead with a broader contribution to society. The best way to build trust is to innovate, and we're committed to giving you regular and transparent updates on our innovation progress. You're going to hear from Hal again on our progress at Q2 this year.

We also remain committed to our global health agenda. We're embedding our more focused approach to achieve maximum impact. Last week the World Health Organization initiated its first pilot of our RTS,S malaria vaccine in Malawi, and we've also dosed the first patient in a phase 2 study for GSK656 in patients with drug-sensitive pulmonary tuberculosis.

So in summary, we've had a strong start to an important year of execution with all of our priorities firmly on track. So I'll now hand you over to Ian who is going to give you more detail on our Q1 financial performance.

Iain Mackay -- Chief Financial Officer

Thanks, Emma, and it's a pleasure for me to be speaking to you in my first quarter as CFO of GSK. All the comments I'll make today will be on a constant currency basis, except where I specify otherwise, and I'll cover both total and adjusted results.

On slide 8 you'll see a summary of the group's results for Q1, which was a strong quarter with 5% revenue growth driven by all three businesses. Group total operating profit is up 10% with total earnings per share up 42%, and on an adjusted basis, operating profit was up 9% and adjusted earnings per share up 18%. There are number of factors benefiting the first quarter operating profit, notably strong growth from Shingrix and introduction of authorized generics, favorable inventory adjustments in Vaccines, and phasing of our R&D investments. I'll go through these in more detail in a moment.

We delivered GBP165 million of free cash flow in the quarter, in line with expectations and please bear in mind that cash flow generation is expected to be -- to be weighted toward the second half of the year. Net debt at the end of Q1 was GBP27.1 billion . The increase from the end of the year was primarily driven by the GBP4 billion acquisition of Tesaro along with the adjustment arising from implementation of IFRS 16 of GbP1.3 billion . On currency, a weaker sterling, particularly against the US dollar and Japanese yen, results in a tailwind of 1% on sales and 4% to adjusted EPS.

Slide 9 summarizes the reconciliation of our total to adjusted results. The main adjusting items in the quarter were charges relating to intangibles resulting from the Tesaro acquisition, major restructuring focused on the supply chain representing non-cash charges relating to ramp up of the program we announced in July 2018, undervaluation of the embedded derivative in respect of GSK's exposure to movements in Hindustan Unilever's share price.

My comments from here onwards are on adjusted results, unless stated otherwise. On the next few slides we've listed some of the key drivers of each business's performance, and I'll also talk you through how we think they will evolve through the balance of the year. Slide 10 summarizes the Pharmaceutical business where revenues were up 2%. Luke and David will take you through the performance of some of our key products shortly, so I'll just point out a couple of important considerations.

The Dolutegravir franchise delivered growth of 7%, while the established HIV products represented a decrease in the quarter. Dolutegravir in Europe showed a decline due to price erosion despite strong underlying volume growth as well as a release of government clawback payments in the comparator period. Looking ahead, we continue to have confidence in the growth outlook of our HIV business. Our two-drug regimen portfolio is important to our future growth, and we anticipate Dovato will become a key contributor, but it will take several quarters as we generate more data, gain broad reimbursement, and as physicians gain experience with the product.

Respiratory sales were up 25%, reflecting the growth of the Ellipta portfolio with Trelegy delivering a strong performance as well as our injectable therapy, Nucala. I want to remind you that from this quarter we are reporting the Ellipta portfolio and Nucala within the respiratory category, and all other respiratory products including, Advair, Seretide under established products.

Relvar/Breo declined 5% globally and 27% in the US despite good volume growth, reflecting the impact of generic Advair on pricing in the ICS/LABA class, which we've been signaling for some time now. We continue to expect Breo to see a decline in the US in 2019, which will result in a slight global decline for Relvar/Breo despite good growth expectations outside the United States.

Our Established Pharmaceuticals portfolio declined 6% with US Advair sales down 27%, as expected following the approval of a generic competitor in February. As we said at Q4, it will take time for inventory levels in the market to adjust and respond to Mylan supply. There continues to be a number of moving factors, including the successful launch for authorized generic, which is providing a boost to Q1 where the full impact of the Mylan launch has yet to be felt.

Keeping these factors in mind, our outlook for Advair remains unchanged.

Ventolin performance was very strong in Q1, also driven by the launch of an authorized generic in January and reflecting a one-time benefit from the initial inventory build. Informed by these factors, we still expect the Pharmaceutical business revenues to see a slight decline in 2019 before returning to growth in 2020, driven by our new products, including Zejula, Dovato, Juluca, Trelegy, and Nucala.

Turning to the operating margin. We saw a decline in the quarter, mainly driven by an unfavorable product mix due to impact of generic Advair; Tesaro's (ph) evolution , which in line with previous guidance we expect to have a sustained impact over the balance of 2019; and R&D spend where we are increasing spending behind priority assets, which will accelerate through 2019.

Slide 11 gives you a quick overview of Vaccines' performance in Q1 with sales up 20% driven mainly by Shingrix with continued strong demand in the United States. We remain on track to deliver (ph) doses in line with guidance previously given with good progress made this quarter. Q1 revenues of GBP357 million is a good indicator of our current expectations of revenue run rate for the remainder of the year. The momentum in Vaccines business continues to give us confidence in the mid-to-high single-digit outlook for sales compound annual growth out to 2020.

In Q1, we saw strong improvements in the operating margin driven by enhanced operating leverage, particularly from Shingrix in the US. It is, however, worth noting that there was a favorable inventory adjustment in the quarter. As a result, we expect to see Q2 Vaccines operating margins more in line with our medium-term guidance of mid-30s percent, which we continue to expect for 2020.

Turning to slide 12, Consumer sales grew 1% despite a drag of around 1% from the combined impact of divestments and the phasing out of low-margin contract manufacturing. This was a lower growth quarter, as we signaled at Q4, mainly due to a more competitive environment in Europe. We're seeing an improvement in performance driven by in-market response and expect growth to pick up in Q2. For 2019, we continue to expect reported growth to be impacted by the loss of around GBP100 million of revenue from the smaller divestments completed at the end of last year and the phasing out of contract manufacturing as we restructure the Consumer supply chain.

Operating profit improved in Q1 resulting in an operating margin of 21.7%. It's worth remembering that Q1 is typically a higher margin quarter due to pre-allergy season sell-in. Margin improvements were driven by continued manufacturing simplification as well as ongoing strong cost control. We're focused on ensuring we invest in the business to drive innovation and better growth, and we expect to see this come through in the remainder of the year. Overall we remain confident in the prospects for the business and are on track to complete the transaction with Pfizer in the second half of the year, and the sale of Horlicks to Unilever by the end of the year, subject to regulatory approvals.

On this next slide we summarize the sales and adjusted operating margin for the group, which I've already covered in some detail. Moving to the bottom half of the P&L, there are a couple of things I want to draw out your attention. Interest expense increased, reflecting higher debt levels, driven mainly by the Tesaro acquisition. Also there is also an adverse comparison to Q1 2018, which had a one-off accounting adjustment of GBP20 million through amortization of interest charges. The introduction of IFRS 16 in the quarter also resulted in an increase on the interest expense line of GBP11 million.

On associates, we had a one-time benefit of GBP51 million reflecting our increased share of after-tax profits of Innoviva as a result of a non-recurring tax benefit. And minorities declined, reflecting the comparison with Q1 2018, which was the last full quarter of distributions to Novartis for their share in the previous Consumer Healthcare joint venture.

On free cash flow, we remain focused on driving greater cash discipline across the group and generated GBP165 million of free cash flow in Q1. The reduction from Q1 2018 mainly reflects the adverse timing of payments for returns and rebates, which we flagged to you at Q4 and an increase in trade receivables on the back of stronger sales, particularly in Vaccines. This was partly offset by improved operating profits and lower contingent consideration payments which last year included a milestone payment to Novartis.

As previously noted and seen in prior years, the generation of cash flows is expected to be weighted to the second half, and we expect to see a step down as the impact of Advair generic flows through and rebate payments are made on pre generic sales of Advair.

For your reference, we provided a slide in appendix bringing together the key points I made on our outlook for the year. And to summarize, our guidance for 2019, including that with respect to the dividend remains unchanged. Our financial priorities are improving working capital management and cash generation, allocation of resources to key priorities including the pipeline and ensuring successful launch of new products, and the integration of Tesaro, completion of the Consumer JV, and disposal of the Nutrition business.

And with that, I'll hand over to Luke.

Thanks, Iain. Good morning and good afternoon. In Pharma and Vaccines, our focus on improved commercial execution continues. We've had a good start to the year, and overall our growth this year will clearly be impacted by the launch of generic Advair. We are seeing our new products perform strongly. Respiratory sales were up 25% at constant exchange rates. Pleasingly Benylsta continues to grow at double-digit rates and Bexsero achieved sales of GBP156 million, up 14% at constant exchange rates.

I'll now go into more detail on some of our newer products. Starting in respiratory, Trelegy continues to do well with sales of GBP87 million in Q1. Globally launches have had a good start, and we now have the only once-daily triple therapy for COPD in 30 countries around the world. 2019 will be an important year for Trelegy as we are executing our launch strategy in Japan and expect to have approval and launch in China later in the year. We're also looking forward to data from the CAPTAIN study, which if successful could enable us to reach patients with asthma that struggle to breathe. In asthma biologics, Nucala remains the market leader in total sales, and continues to grow quarter-over-quarter.

On past results calls, we signaled that we needed to improve commercial execution with Nucala. There's more work to do, but we're seeing some encouraging signs. As you can see from this chart, it looks at an estimated new patient starts across both retail and non-retail segments, and we now have closed the gap with (inaudible) in new patients and are now back to a one-to-one position versus our closest competitor.

We track several measures, but new patient starts remain a key target because the IL5 class as a whole can grow a lot more. We estimate that out of the 340 severe eos patients eligible for a biologic in the US, less than 25% have received one today. Finally, we're excited about the opportunity to provide the convenience of home administration later this year.

Next slide please. I also wanted to highlight Zejula, a market-leading PARP inhibitor for recurrent maintenance therapy of ovarian cancer in the US. In Q1 GSK reported sales of GBP42 million, but when factoring in Q1 sales prior to the acquisition, sales were at GBP56 million. Our share of the second line maintenance for ovarian cancer is stable, and we're looking to improve our competitive focus as we integrate our commercial operations.

Zejula is now approved in 35 countries globally with an established presence in the US, Germany, the UK, and Italy. Our teams are now (ph) establishing France and Spain, and we plan to launch with a partner in Hong Kong before the end of the year. PARPs remain an important option for ovarian cancer patients, and we continue to believe the class is underappreciated.

As we've mentioned before, evidence suggests that there is a significant opportunity to help many more patients than those with the gBRCA mutation, including those who are HIV positive and potentially all-comers in the first-line maintenance setting. Linked to this, we look forward to getting the PRIMA data which will give us more information about this opportunity by the end of the year.

Moving on, we're very pleased by the strong execution of Shingrix as we continue to expand and accelerate capacity to deliver the significant step-up in doses in 2019 versus 2018 that we had previously indicated to you. In the US where demand remains high, we're seeing more than 75% of individuals who received their first dose of Shingrix complete the two-dose series. In terms of who is getting vaccinated, it's consistent, we continue to see more than one-third of individuals aged under 65 and also more than one-third of those receiving Shingrix have previously been vaccinated with the competitor. And our capacity expansions remain on track.

And now I'll hand over to David.

David Redfern -- Chief Strategy Officer

Thanks, Luke. Good afternoon, good morning, everyone. During Q1, HIV grew 4% CER to GBP1.1 billion , which comprised the Dolutegravir portfolio of Triumeq, Tivicay, Juluca growing at 7% CER offset by the anticipated continued decline of the mature portfolio. This was slightly slower growth than in previous quarters due to the significantly larger base of the overall business and the more competitive environment.

In the US we remain encouraged by the performance of Juluca, which is continuing to gain share with greater than 2,200 scripts per week and over 1,800 physicians now prescribing, giving sales of GBP70 million in the quarter. We have seen a pickup in Juluca since the publication of the 96-week SWORD data in October of last year and this is now being further endorsed by the positive 148-week data. Around 65% of the Juluca business continues to be sourced from non-Dolutegravir combinations. We believe this is a good indicator of growing prescriber confidence in two-drug regimens which will now be further reinforced by the launch in the US of Dovato.

The US business grew 3% CER with the Dolutegravir portfolio growing by 4% offset by the decline in the mature portfolio. In a continuation of a trend we have previously flagged, we've seen some switching of the margin of the Triumeq business in particular to both Juluca and competitor STRs, and the overall market share of Dolutegravir-based regimens in the STR and core agent market has declined slightly and is now around 26.5%.

Tivicay Descovy remains a popular and broadly stable business and through the second half of the quarter we have seen Tivicay MB/RX improve. Future growth in the US will come from our two-drug regimens, Juluca and now Dovato in 2019, with cabotegravir-rilpivirine long-acting providing further momentum subject to FDA approval from 2020.

In Europe the Dolutegravir volume grew 8% driven by share growth in most markets, but the overall HIV business declined 6% in the quarter this was driven by three factors: firstly, price cuts over the last few months in France, Spain, and Italy, all these price cuts were government mandated; secondly, a challenging 2018 comparator which included a one-off clawback release on Triumeq in Q1 last year in Italy; and thirdly, the drag from the mature portfolio. We expect the impact from these factors to reduce to some degree as the year goes on. In the international region the business continued to grow strongly at 29% CER, including good contributions from Japan and Brazil.

Next slide. Turning to Dovato. We are very pleased by the approval by the FDA in April and the recent positive opinion granted by the CHMP in Europe last week. We will continue to invest in generating further clinical evidence to support Dovato, including in broader patient populations. This will include GEMINI 96-week data, which we expect to be available over the summer, and if positive, should help to reinforce confidence in the durability and resistance barrier of Dovato; the TANGO; and then subsequently SALSA switch studies, which we anticipate will enable us to file for a switch indication in the US, and also a number of other Phase IIIB/IV studies.

Turning to our long-acting injectable cabotegravir rilpivirine, we have now filed in the US with the EU submission to come shortly. Later in the year we will report out the eight-week dosing study. This is important as it would enable patients to reduce their injections from 12 per year to just six, quite an amazing shift if successful from current standard of oral -- daily oral care with 365 tablets taken per year.

And finally, fostemsavir, an important medicine for patients with few treatment options remaining, is on track and we continue to anticipate filing by the end of 2019. Overall, therefore, we continue to have confidence in the growth profile of our HIV business.

With that, I will hand back to Emma.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Thanks very much, David. So, as a reminder, we've seen good progress this quarter on our priorities of innovation, performance, and trust, and we are firmly on track with our key areas of focus. It's important that we now build on this momentum for the year. So we're driving improvements in our operating performance, we're progressing our pipeline with a number of major readouts to come, and we're working toward a successful integration with Pfizer once the Consumer JV has completed.

Successfully delivering these priorities over the coming years will provide a clear pathway to the creation of two great businesses: one focused on Pharma and Vaccines, the other on Consumer Health. So we are now joined for our Q&A with Hal on the line and also Brian and Roger. And so with that operator, the team is now ready to take questions.

Questions and Answers:

Operator

Thank you. Your question-and-answer session will now begin. (Operator Instructions) The first question is from the line of Keyur Parekh of Goldman Sachs. Your line is now open. Please go ahead.

Keyur Parekh -- Goldman Sachs International -- Analyst

Good afternoon. It's Keyur Parekh from Goldman Sachs. Two questions please. One for Hal and one for Iain. Hal, I noticed there's a slight delay on the timelines for the BCMA study in the second line multiple myeloma setting. Just wondering if you could give us some color around that. What's causing this data to go from first half to the second half? And then secondly, for Iain, Iain as I look at Q1 and I look at what's implied for your guidance for the rest of the year, it feels like you're implying margin degradation of somewhere in the region of 250 to 300 basis points across the company. I realize there are several kind of factors are going to drag margin down, but just help us think about kind of is there upside to that margin number? Where could there be potential for you to take guidance up as you feel more comfortable with the rest of the year? Thank you.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Well, thanks very much, Keyur. So we'll go first to Hal and then come over to Iain.

Dr Hal Barron -- Chief Scientific Officer and President, R&D

Thanks, Keyur. Thanks for the question. As you know, we started a lot of studies to accelerate our anti-BCMA ADC program. And I should point out that our timelines for the DREAMM-2 monotherapy study in fourth line remains on track, and we're expecting to report off the data at the end -- later this year and file by the end of the year as well.

As you point out, we've noted a delay in the pilot study in the second line, and that was really driven by discussions we were having with the FDA and actually decided to modify the protocol to enable us to have more patients and a more robust understanding of the dose response and dose exploration and to enable us to design the DREAMM-7 and 8 studies optimally. That resulted in increasing number of patients, and so that's going to delay the readout. But importantly, this is not driven by any adverse safety signals in the studies, just to remove any concern of that. And I should also point out that we're aggressively exploring options to make up for this delay in the dose exploration, so that it'll have hopefully less impact on the ultimate approval date.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Thanks very much, Hal. And so, Iain, following on from our strong start, what about any comments on Keyur's question on the guidance?

Iain Mackay -- Chief Financial Officer

Keyur, thanks for your question. In terms of key influences on outlook for the whole year, really no significant change from the guidance we gave at the fourth quarter. Key influences on it, Keyur, the full integration of Tesaro and with that a significant step up in R&D expenditure, specifically in that area. More broadly in R&D, continuing to invest behind our priority programs across the pipeline.

Another key feature which we still haven't seen the full impact of it playing through, in fact really only the initial, is the Advair genericization and the impact obviously of Mylan but also our own -- the introduction of our own generic Advair in that regard. And then one other feature which we have mentioned that sits within the first quarter, which is somewhat flattering to the operating margin, are a couple of inventory adjustments within the Vaccines business specifically, which would most definitely have an impact on the Vaccines' operating margin but also more broadly for the group.

So more broadly, within that range of down 5% to 9%, notwithstanding a really strong performance from Shingrix in the quarter, guidance for the moment, early as it is, very much as it is, and it goes without saying hopefully that as the year progresses, we'll keep you posted on how we see those margins developing.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Thanks very much. Next question please.

Operator

Next question is from the line of Jo Walton of Credit Suisse. Your line is open. Please go ahead.

Johannah Walton -- Credit Suisse Securities (USA) LLC -- Analyst

Thank you. My questions are along the same lines. I wonder as a new CFO coming in from another industry, whether you could give us your initial thoughts on the -- particularly the cost structures that you see. You have highlighted tight cost control going forward. It's always interesting to hear another person's views of costs in this industry. And the second question, going back to generic Advair, if we look at the prescription numbers, it does look as if there may be some capacity constraints with the generic, because the generic isn't appearing to gain any more share and the share is stabilizing with yourself and your authorized generic. I wonder if you could just tell us what you think is happening in the market because maybe you've got a better sense of that than we have.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

So, hi, Jo. So just firstly on the Advair generic I think and then I will come back to Iain to speak for his first impressions. But it is early days. I don't think it's for us to comment on the supply of Mylan. But at the moment, we think we are completely where we would expect, and there's no change to the outlook that we've previously shared in terms of our expectations for Advair overall in 2020. But Iain, would you like to comment on ...

Iain Mackay -- Chief Financial Officer

Comment on costs.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

First impressions.

Iain Mackay -- Chief Financial Officer

First impressions. As you quite rightly pointed out, Jo, there are both dissimilarities and similarities across the two sectors, believe it or not. I think initial observations, there are a number of important, I shan't call them restructurings, but refocusing of energy within the firm that I'm seeing the early indications of. And that is the work that Luke and the team is doing across pharma commercial in terms of really orientating the commercial organization to the key priorities around product launch and building revenues. And through that process seeing some reorganization from that very effective cost control in that regard.

Equally as we've talked about before, the work that Hal is doing in the R&D organization about which we talked about in some detail at the midpoint last year also is focused on improving the overall effectiveness but also the efficiency of the R&D organization. So what I see initially is a strong focus on cost management across the organization, whether it's in the SG&A areas, whether it's specifically within R&D, whether it's within the supply chain across Vaccines, Pharma, and very notably within the Consumer -- the Consumer Healthcare space as well.

So I think my first impression is there's a very strong focus on improving the overall efficiency and effectiveness and margins of the organization with a broad range of activities across really every line and cost category across the P&L. So in summary, favorable.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Thanks, Iain. Next question, please.

Operator

Next question is from the line of Graham Parry of Bank of America ML. Your line is open. Please go ahead.

Graham Parry -- Merrill Lynch International (UK) -- Analyst

Great. Thanks for taking our questions. First question is on HIV. So we start to see some formularies such as Express Scripts, national formularies start to add HIV to its exclusion list this year. GSK drugs are still on formulary. Can you run through whether GSK has had to offer any increased rebates to keep the portfolio there and if you expect that to increase price pressure over time? And then secondly on the Vaccines margin of 40%, I think you talked about what the 2Q should look like, but it would be helpful if you could just quantify and strip out both the rebate benefit to Shingrix and the phasing benefits across the portfolio so we can understand what the right underlying and ongoing level for both Shingrix and the rest of the portfolio would be as we're trying to calculate the rest of the year. Thank you.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Thanks very much, Graham. So first to David, knowing that we've never given detailed updates on our commercial relationships, but first to David and then Iain perhaps on the Vaccines margin.

David Redfern -- Chief Strategy Officer

Yes. Thanks, Graham. So as you say, we do have very strong formulary access for Tivicay, Triumeq, and Juluca, very strong coverage. And as I've said, it's pretty stable. And we are in the discussions over with Dovato having been recently approved with the payers in the US and the initial feedback we've had is the WACC price, which is the lowest integrase STR in the market, has been favorably received. And those discussions are going very well. So no real significant change in the dynamic.

I mean I think the one thing that is going on with the payers is that -- some of them at least are trying to much more actively manage their formularies to line up with the guidelines and HIV is very guideline-driven. The guidelines are updated regularly. So you see some formularies like ESI and others, excluding some of the older tenofovir-based regimens. So that is going on. But overall, very stable and we have very strong coverage and we're very optimistic about the coverage we're going to get for Dovato.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Vaccines, Iain.

Iain Mackay -- Chief Financial Officer

Yeah, Graham. On the -- on the Vaccines margin front, taking broadly the influence of both rebating and inventory adjustments across that portfolio for the quarter, it contributed positively about five points to the margin in the quarter together. And in total in sterling terms represented about GBP70 million in total.

So when you -- when you think about the guidance we provided previously, looking out to 2020 that gives you a margin broadly consistent with where we would expect the Vaccines business to be in 2020. That is not to say that we would expect necessarily the Vaccines business to be at that level for the remainder of this year, but that is the impact and that rebating was specific to Shingrix and then inventory adjustments were across a broader range of products within the portfolio.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Thanks, Iain. Next question please.

Operator

Next question is from the line of Tim Anderson of Wolfe Research. Your line is open. Please go ahead.

Timothy Anderson -- Wolfe Research, LLC -- Analyst

Thank you. I have a question on consensus modeling for Tivicay and Triumeq. According to the data that you guys collect, consensus really has those two franchises as pretty much flat over a five-year window on a global basis, but if I look at script trends at least in the US, it shows some pretty stiff competition from Gilead. So I'm hoping you can give us some perspective on whether you think consensus modeling again for Tivicay and Triumeq over something like a five-year window is right.

Second question is just if you could disclose emerging market performance in the quarter, including China performance. Thank you.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Okay. Thanks very much, Tim. So I'll come to David in just a moment to comment a bit on shares and outlook in HIV, knowing that we never comment on the specifics of consensus. And in terms of emerging markets, we were up 6%. We don't explicitly disclose on China, though we're happy -- I'm sure Luke will be happy to give some comments later if anyone wants to ask on what our plans are in our China business. But David, do you want to just comment on ...

David Redfern -- Chief Strategy Officer

Yes. Thanks, Tim. So we're not going to comment specifically, as Emma says, on consensus, but I'll just make a few remarks. I mean firstly, obviously, HIV is a competitive marketplace, but overall actually I think we traded during Q1 very much in line with our expectations. There has been some switching at the margin, as I said in my remarks, particularly on Triumeq. But overall, we're running at, certainly through the quarter, at about 32,000 to 33,000 scripts, so relatively stable.

What is true is that going forward in the US we see the vast majority of the growth coming now from our two-drug regimens, so Juluca initially but hopefully now also Dovato and then from next year, subject to approval, cabotegravir. So that is where the growth will come from, and to some degree there will be some cannibalization of Tivicay and Triumeq in the US, particularly probably Triumeq into the two-drug regimes and that will be fine. So that is where the growth will come from. Outside the US it will be more broadly based, including Tivicay and Triumeq.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Thanks, David. Next question please.

Operator

Next question is from the line of Peter Welford of Jefferies. Your line is open. Please go ahead.

Peter Welford -- Jefferies International Ltd. -- Analyst

Thanks. I've got my customary two questions. So firstly on Nucala, I wonder if you can just comment there in regards to the trends I guess you're seeing now starting to evolve perhaps in the marketplace, obviously a new competitor entering and also perhaps new auto administration reaching the market before yours. And so how do you sort of think -- we should think about that product for the remainder of the year given I think some prior sort of more cautious commentary you've given perhaps ahead of this quarter? And then secondly, just on BCMA (inaudible) just with regards to the multiple myeloma combo trial with the (inaudible) that you've initiated, just would love to hear the thinking behind that trial given obviously there's been a number of setbacks with the PD-1s in this indication, and also whether or not you're confident manufacturing for that is ready to be able to file by year-end when you get the data from the fourth line trial. Thank you.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Okay. Luke and then over to Hal.

Luke Miels -- President, Global Pharmaceuticals

Yeah. Thank you for the question. So I mean I think with Nucala, it's been very much back to basics with us. We've worked very hard to establish a clear positioning in the market. We've focused on productivity of the sales force, the medical teams, and I think you're starting to see the benefits of that flowing through.

In terms of the broader dynamics, I mean again we -- I think we're holding our own. Dupilumab seems to be taking the bulk of its business from (inaudible), not from the IL-5 class and I think that there's no signs of that shifting at this point.

In terms of -- and also our expansion beyond the US I think we're doing quite well. I think we have a better understanding of the patient profile and the true size of the patient pool in countries in Europe, and we're doing very well with around 70% market share in Japan.

In terms of the 38 autoinjector, I mean it's very, very interesting. If you look at perception mapping around Nucala historically, there we were able to work on the efficacy profile, we were able to work on the mechanism, all of these components, but obviously one of the challenges that we had that was difficult to move with what we have available today is this perception around dosing frequency.

So the opportunity for the autoinjector provides another option for patients and physicians, so really they have the choice whether they want to dose every four weeks in the office or write a script and enable those patients to subsequently dose at home. So it's an attractive option for us. We're very much focused on the launch. We expect approval in the second half of the year in the US and Europe.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Thanks, Luke. Hal?

Dr Hal Barron -- Chief Scientific Officer and President, R&D

Yeah. Thank you for the questions. First of all, yeah, we will have the data to review by end of year and there won't be any concerns really from a manufacturing perspective in terms of filing the fourth line data, so in the second part of your question.

In terms of the PD-1 combination trial, it's important to point out actually that the BCMA ADC really has multiple mechanisms. It not only inhibits the BCMA signaling, which is important for plasma cell survival and obviously the toxin conjugate, the ADC component gives it enormous potential for destroying the plasma cells as well, but the antibodies afucosylated which also gives an immune component, so a very enhanced ADCC.

And lastly what we observed preclinically is that there's a -- there's a significant immune component to this therapy that may be due to the ADC or maybe even to the ADCC, but we see preclinically a very interesting immune response that we think will be synergistic with PD-1. You're right to point out that previous trials with pembro haven't been successful. In fact I think taught us a lesson about how to think about PD-1 inhibition in diseases, in particular myeloma, and we're going to leverage that finding where there sometimes is an early hazard that one needs to progress past in order to see the full benefit, as you can see now with the longer-term follow-up. So we think based on the mechanism and based on some preclinical data, we think that this is a smart risk to take, and we'll see what the data shows.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Thank you, Hal. Next question please.

Operator

Next question is from the line of Steve Scala of Cowen. Your line is open. Please go ahead.

Steve Scala -- Cowen and Company LLC -- Analyst

Thank you. In 2015, the company provided six or seven pieces of 2015 to '20 guidance. Iain, I'm just wondering if you have embraced all seven or if you are revising any? And just briefly, if you will allow me, Pharma was low single-digit ex-Vaccines. Vaccines was mid-to-high single-digit, but that now looks light. Respiratory at 2015 levels that looks light. Consumer low-to-mid single-digit that looks aggressive. Total company low-to-mid single-digit, EPS mid-single digit, tax rate increased two to three percentage points over the next three to five years. And if I missed any, please reflect on those as well. Thank you.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Iain.

Iain Mackay -- Chief Financial Officer

Steve, that was a fairly kick-ass question. Thank you. Look, I think from where -- from where I sit, somebody that started my job 30 days ago, what I am particularly focused on is how we close out the remainder of 2019 and build on the progress that we made in the first quarter. I think at the fourth quarter we talked about the 2019 guidance and how that took us through to 2020. And in that regard, the guidance that we updated then and that we've reaffirmed today I think is hopefully suitable guidance for you to think about how the pharma as a whole progresses through 2019 and then sets up for 2020.

Clearly the composition of the business is changing somewhat. We're going into a JV subject to approvals with Consumer Health later this year, which will have an impact obviously in terms of how Brian and the team perform in that regard. And obviously we've done the transaction in Tesaro, which clearly changes the shape somewhat of Pharma. And obviously there's a couple of disposals going on as well.

So I think the shape -- the shape of the organization is changing. So if I would dare to suggest a way of thinking about the guidance is how we've updated at the end of last year, how we've updated today, or rather reaffirmed around that with a strong focus on execution in 2019 and setting yourself up for 2020.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Thanks, Iain. Next question please.

Operator

Next question is from the line of Laura Sutcliffe of UBS. Your line is open. Please go ahead.

Laura Sutcliffe -- UBS Ltd. -- Analyst

Hello. Thanks for taking my questions. Obviously Shingrix is doing very well. I noticed you have killed your universal flu vaccine project, though. So could you maybe just talk a little bit about what you're excited about in the Vaccines pipeline, what they might be coming up after Shingrix? And secondly, I'm going to ask the question that Emma mentioned about your ambitions in China. Could you maybe speak a little bit about that, too, outside of Consumer Health? Thank you.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Of course. So we'll come to Luke in a moment on China, but since we have Roger Connor also in the room who's been working not only on the improvements in our supply in Shingrix but is also responsible for the R&D organization there. So do you want to comment on the pipeline perhaps?

Roger Connor -- President, Global Vaccines

Yeah, will do. Listen, thank you very much for the question. You'll notice that there were two assets in our Vaccine pipeline that we have removed this quarter. First of all, not a concern. These are not priority assets. Just maybe to walk through the assets in particular. One was, as you mentioned, the universal flu asset, which is a partnered asset in Phase I and II that we have stopped following an interim data analysis.

Just to emphasize, we're still very much committed to flu development, and we are looking at the early stages of our pipeline looking at alternative approaches in the universal flu space. Just for information, the other asset that we stopped was a next-generation option for prevention of pneumococcal disease. We were looking at new technologies there. Again, not viable to go forward. Again, these are not priority assets for us and really allow us to stay focused on our priority assets in our pipeline.

And maybe I'll just mention two very quickly. One is our RSV portfolio. I'm very excited about this. We have in Respiratory Syncytial Virus three different vaccines in development. As you -- as you'll know I'm sure, RSV is the single biggest cause of hospitalization in infants under one. And we have three vaccines in development, one for pediatric, one for maternal, and one for older adults, and we look at that portfolio, where actually we think there is a real potential for first on best-in-class vaccines within that portfolio. And you may have seen already that our older adult and maternal vaccine in RSV they both have received a prioritized fast-track designation from the FDA. So lots going on in RSV for us and an exciting area. On our older adult I should just emphasize as well that vaccine will use to ca modulin system as our Shingrix vaccine, which proved very effective there.

And just on another asset in the pipeline that we are looking at very closely in prioritizing is COPD, chronic obstructive pulmonary disease. Again, this vaccine will use our adjuvant system again. It'll be a therapeutic vaccine, and we're looking to see how do we exploit the adjuvant technology to go into this therapeutic space. And on COPD in particular, this is the first vaccine against COPD, which is looking to really address exacerbation with and disease progression. Exacerbations are caused by -- are associated with let's say bacterial presence, and we feel that a vaccine addressing those bacteria could have a big impact. So exciting times in the pipeline. But those are just two of the priority assets we have.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Thanks, Roger. So Luke, China.

Luke Miels -- President, Global Pharmaceuticals

Sure. Thanks, Laura. So I mean we remain very positive about China. I think in contrast to a number of peers, we have a very concentrated portfolio there. And so when we look at the opportunities I think in in the immediate products that we have today, the first is Seretide. I think it's probably well known to everyone that COPD is significantly undertreated even when it is diagnosed in China. So we see that as a major opportunity to expand the usage of that product there.

Cervarix we're still in the early days of the introduction there. We have around a third of the patients who are taking HPV -- who are vaccinated with HPV. And then linked to that is the opportunity to broaden the Vaccines portfolio within China. And then underlying all of this is really just working very hard on our commercial and medical execution in country, and then ultimately working hard in partnership with Hal and his team to accelerate the introduction of pipeline assets such as BCMA and hep B into China.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Thanks, Luke. I mean in the end, obviously we are starting for the reasons you're all familiar with from a lower base. That gives us opportunity for growth in arguably one of the most exciting markets at the moment, not least because of deregulation that's going on around innovation, as Luke has alluded to, and we sat on slightly less exposure relatively in terms of the pricing around branded generics. So more to come there and we'll see where the Shingrix approval goes in due course. Okay, next question please.

Operator

Next question is from the line of Richard Parkes of Deutsche Bank. Your line is open. Please go ahead.

Richard Parkes -- Deutsche Bank AG -- Analyst

Hi. Thank you very much for taking my questions. First one for Iain on free cash flow and the balance sheet. You called out -- and you have done previously, a step-down in free cash flow generation this year due to generic Advair, but just wondered if you could give us some kind of steer on where it now might fall out in terms of dividend cover this year and how you're feeling about what flexibility there is still in the balance sheet to do business development and maybe talk about what the path is to deleveraging the balance sheet and maybe get more aggressive there in terms of business development. That's the first question.

Then secondly on the HIV franchise. Obviously European sales saw a decline and I think you flagged the price reductions. I'm just wondering how you expect that to play out for the full year. Can HIV in Europe still grow this year and are you seeing any impact from tegravir launches in that number. Thank you.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

So David, why don't we go to you first, just comment on HIV, and then we'll come back to Iain. No, we don't guide on cash flow in the year, but I will come back to Iain on your other broader finance questions.

David Redfern -- Chief Strategy Officer

Yes. Thanks, Richard. So HIV in Europe, the volume actually grew very strongly, dolutegravir volume up 8%, with some very good performances in France, Spain, and Italy, and actually particularly pleased about how Juluca has started in France. But as I said, there was some government-mandated price cuts in a few markets. So, for example, in France, the fifth anniversary from your launch, you often have to take a price cut. And that was the case with Tivicay. So these won't happen every year, but it's normal part of life in Europe, which impacted the quarter and will obviously have an impact across the year. And then there was some comparative -- there was a one-off comparative in Italy. So the impact will dissipate during the year, but it won't totally go, but overall pretty pleased with the performance.

I mean in terms of the competition, it is obviously heating up in Europe, particularly in Germany, which is -- the markets are all very different in Europe. Germany is probably the most like the US in the sense it's a free market for pricing and also the most favorable to STRs. And we have seen some switching at the margin there to the competition. But everywhere else we've been growing market share, and we're quite pleased.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Thanks, David. So over to Iain, and just in terms of the BD appetite point, I will say we are largely focused on digesting exactly the rather significant number of deals we have in hands. But Iain, comments overall.

Iain Mackay -- Chief Financial Officer

Yeah. Richard, thanks for the question. Clearly strong focus in terms of working capital management, cash flow generation across the company with that embedded in everybody's goals and objectives. Just talking about the full year, we talked -- obviously last year very good year from a cash flow perspective with GBP5.7 billion for the full year.

What we talked about at the fourth quarter was the expectation -- a couple of things; one, lower profitability in line with the guidance for the full year; other things kicking in; the full impact of Advair, which we would expect to see coming through over the next quarter or so; continued to step up R&D and the investment behind our priorities in that pipeline an important factor; another thing, building on the announcement around the middle of (ph) 2000 July with respect to restructuring. We'll see a bigger impact of restructuring in 2019. So those factors, as we said at the end of the year, we'd expect to see cash generation somewhat lower than was the case in 2018, but nonetheless a very, very strong focus in that area.

Guidance today on the dividend, obviously no change, reaffirmed expectations around the GBP0.80 per share for the full year 2019. And in terms of thinking about capital allocation more broadly, and Emma talked about really focusing on implementing, executing the transactions that we've got in the pipeline now, and realizing value from those transactions. Clearly, one of those, the disposition of the nutrition business in India to Unilever, will generate significant cash flow as the -- as that deal closes and will go largely to improving overall balance sheet capacity.

And when we think about that capacity, it's around supporting the pipeline, returns to shareholders through the dividend, and this continued aspect of looking for business development that contributes to strengthening the long-term future of the firm, subject obviously to pretty strict return criteria and structuring within those transactions. But it would not be an understatement to say that there is very, very sharp focus across the firm on cash generation.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Yeah. I certainly confirm that. And just in terms of what the pathway is, I'll just remind everybody that in -- we're obviously very excited about getting to the close, subject to necessary approvals of the Consumer deal. We're then going to be focused on a successful integration, which we are confident we can deliver. And then up to three years after close, we do intend to separate these companies. And that will create the reset of the capital structures for both businesses, which then creates a whole new level of capacity for that Pharma and Vaccines company focused on the science of immunology to technology and genetics to both invest in further growth organically and inorganically and deliver returns to shareholders. Thank you and next question please.

Operator

Yeah. The next question is from the line of Simon Baker of Redburn. Your line is open. Please go ahead.

Simon Baker -- Redburn Partners LLP -- Analyst

Thank you for taking my two questions. Firstly, just continue really off on Richard's question on free cash flow. Perhaps I could broaden out a little for Iain to get your perspectives at this admittedly early stage on where free cash flow conversion is, notwithstanding the one-off effects in the quarter and where you think it could and should be in the coming years. And then secondly, a question for Hal. There was a report out from the IQVIA Institute last week suggesting the potential impact of various new technologies on R&D productivity. Given that the history of R&D is littered with technologies which have over-promised and under-delivered, it'd be very interesting to get your perspectives on what you think are the principal technological drivers of increased R&D productivity over the coming years. Thanks so much.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Fantastic. So we'll come to Iain first, and then come over to Hal on the phone knowing that again he will be giving you an update on the this and including that question I think at Q2. But first of all, Iain, any further comments you want to make on cash flow?

Iain Mackay -- Chief Financial Officer

Not a great deal, just to emphasize the focus around working capital management across the organization as a whole and looking broadly across the balance sheet and the wider portfolio in terms of opportunity to create monetization opportunities where returns are presently below hurdle rates that we've set. And that's a piece of work that we do across each of the businesses on an ongoing basis. The focus is there, really nothing more precise on the guidance in that regard.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Thanks, Iain. So, Hal, new technologies?

Dr Hal Barron -- Chief Scientific Officer and President, R&D

Thanks for the question, Simon. I think there's no question that the R&D organizations across Pharma can benefit from improvements in productivity. And I would say the focus for us is being driven by the observation that only about one in 10 molecules that enter the clinic actually ends up becoming a medicine and helping patients. And we're pretty focused on seeing if we can increase that substantially.

And the three technologies that we have identified as that we believe will improve this dramatically potentially is human genetics and with the reduction in the cost of sequencing as well as the number of people and patients who have been signing up for various sequencing opportunities, such as 23andMe where we have now millions of patients who've donated their genetic information to help us understand better targets. We think it's going to be a very important technology.

In addition functional genomics, which is essentially taking that genetic data and being able to understand what does it really mean, what is the structural variance telling us about human disease, could also enable us to find much, much better targets. And given how massive these datasets can become when you do all these technologies, we really do believe that machine learning and artificial intelligence applied to these highly dimensional datasets can unravel the biology in a pretty profound way, and all three of these are growing in sophistication.

And I'll be talking a lot more about this at Q2, but we've already started seeing some interesting targets that were never identified previously, and we think that because they're driven really by using the human as the model organism, if you will, using human genetics and functional genomics, we think this could have a significant impact on our probability of success and therefore our productivity. But more on that in Q2.

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Thanks very much, Hal. And with that I think we've come now to the end of the call. So I'd like to say thank you to everybody for joining. Good to hear your voices, and we look forward to catching up soon. Thanks, bye.

Duration: 62 minutes

Call participants:

Sarah Elton-Farr -- Head of Global Investor Relations

Emma Walmsley -- Emma Walmsley, Chief Executive Officer of GSK

Iain Mackay -- Chief Financial Officer

David Redfern -- Chief Strategy Officer

Keyur Parekh -- Goldman Sachs International -- Analyst

Dr Hal Barron -- Chief Scientific Officer and President, R&D

Johannah Walton -- Credit Suisse Securities (USA) LLC -- Analyst

Graham Parry -- Merrill Lynch International (UK) -- Analyst

Timothy Anderson -- Wolfe Research, LLC -- Analyst

Peter Welford -- Jefferies International Ltd. -- Analyst

Luke Miels -- President, Global Pharmaceuticals

Steve Scala -- Cowen and Company LLC -- Analyst

Laura Sutcliffe -- UBS Ltd. -- Analyst

Roger Connor -- President, Global Vaccines

Richard Parkes -- Deutsche Bank AG -- Analyst

Simon Baker -- Redburn Partners LLP -- Analyst

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