Emma Walmsley - GlaxoSmithKline Plc Simon Dingemans - GlaxoSmithKline Plc David Simon Redfern - GlaxoSmithKline Plc Patrick J. T. Vallance - GlaxoSmithKline Plc.
Graham Parry - Bank of America Merrill Lynch Richard Parkes - Deutsche Bank AG Jo Walton - Credit Suisse Securities (Europe) Ltd. Andrew S. Baum - Citigroup Global Markets Ltd. Timothy Minton Anderson - Sanford C. Bernstein & Co. LLC Kerry Holford - Exane BNP Paribas Michael Leuchten - UBS Ltd.
James Daniel Gordon - JPMorgan Securities Plc Seamus Fernandez - Leerink Partners LLC Vincent Meunier - Morgan Stanley & Co. International Plc.
Thanks, Sheila. Good afternoon, everybody. And a warm welcome to this call in which we're reporting our first quarter results. It's a great honor for me to be here as the new CEO of GSK. And I'm looking forward to speaking with you and to getting to know you more in the many quarters ahead.
Hosting this call with me today is Simon Dingemans, our Chief Financial Officer, who's going to talk through the detail of our results in just a few moments. For all of our quarterly results calls from now on, Simon and I are going be joined by different members of our management, which I hope you'll find helpful for your questions.
And will give you a sense of the GSK team as well as different aspects of the company. So with us here today are Patrick Vallance, our head of R&D, and also David Redfern, Chairman of our HIV business, also our Chief Strategy Officer. Before I hand over to Simon, let me make just a few comments.
Firstly, as I just said, it's a real privilege to be leading this great company. We have many dedicated and highly professional people working for us and with us all around the world. And I'm optimistic about what we can do better for patients, consumers, and our shareholders. Our company has an important purpose.
And I believe that with the right investments in science, technologies, and our people, we can make very meaningful differences to health in all parts of the world. I also believe that with disciplined allocation of capital and a clear focus on generating competitive performance, we can realize value and deliver returns for our shareholders.
The results we publish today confirm that we're making good progress in the recovery of our financial performance after some difficult years. Group sales were £7.4 billion, up 5%. And adjusted earnings per share were 25% (sic) [25p] for the quarter, plus 9%, both at constant exchange rates.
We saw further improvement in the group operating margin, reflecting growth in sales and ongoing tight focus on costs and benefits from our restructuring programs. I'm also pleased with the continued improvement we're making in cash flow generation.
Free cash flow for the quarter was £650 million compared to £240 million outflow in the same quarter last year. So all together, this is a positive start to the year for GSK. It is important that we now continue to deliver reliable performance for the rest of 2017.
We have to do this whilst navigating a challenging and unpredictable commercial, regulatory, and political environment and with potential for generic competition to Advair in the U.S. still to come. Now there's obviously still a lot of uncertainty around this, but as we've said previously, this is an event we have planned for.
And the financial guidance we set out in February absolutely reflects this, and we have reiterated that guidance today. Our clear short term and immediate priority in this context is to deliver excellent commercial execution. And that means making sure that the momentum in new product growth is maintained in all three of our businesses.
And that we're also well prepared for our near term launch opportunities with the immediate focus being on Shingrix in vaccines, closed triple in respiratory, and the first of our two drug regimens in HIV. And we expect regulatory decisions on all of these over the next 12 months.
This focus on execution now is particularly important, given that our next significant wave of new product launches is not expected until the early 2020s. And longer term then, the big focus must to be increase – deliver innovation in all three of our businesses.
And the clearest priority here being making the right choices to develop our Pharma pipeline, which is promising but still unproven. And we have a lot of work to do here. And we need to make sure that our R&D and commercial organizations are partnering really effectively together.
Our new commercial leader, Luke Miels, is going to be a strong addition to the team here. We're going talk to you all in more detail about these and our other longer term priorities for the company in July, alongside our Q2 results. In the meantime, let me now hand over to Simon, who's going to take you through the quarter in a lot more detail..
Thanks, Emma. The results that we've reported today reflect another quarter of strong execution and progress against our strategy and the goals we've set out in our financial architecture. All three of our businesses have continued to contribute to our revenue growth.
And we've leveraged that sales growth, controlled costs, and delivered further restructuring benefits, improving the group's operating margin, while still continuing to make substantial investments both behind our pipeline and the new products.
We've also delivered a substantial improvement in our free cash flow, which was up £0.9 billion compared to Q1 last year. Our earnings release provides an extensive amount of detail on the results.
As usual my comments will focus on the major points, our expectations for 2017, and some comparative points you might want to take note of for your modeling. As always, my comments will be at constant changes rates, except when I specifically refer to currency.
Starting with the headlines, group sales were up 5%, total EPS was 21.4p compared to 5.8p last year. Adjusted EPS was up 9%. On currency, the weakness in sterling resulted in a tailwind of 14% on sales and 22% on adjusted EPS.
And unless sterling appreciates significantly from current levels, we would still expect a tailwind from currency this year, particularly in the first half.
If exchange rates were to remain in line with last Friday's close, which takes account of some of the recent strength of sterling, we would expect the full year tailwind to adjusted EPS from currency to be approximately 8%.
Total EPS was 21.4p, a significant increase on last year, driven by our improved operating performance, but also lower restructuring costs as we wind down into the final stages of the program.
And we also saw much lower charges for transaction-related items, particularly revaluation charges for the liabilities we carry for contingent consideration on the Consumer and ViiV put options. Last year's movements were driven by improved performance expectations.
This quarter our expectations for the businesses concerned have not changed significantly and neither have exchange rates compared to the end of last year. We also recorded a gain of 3.9p on disposals, primarily relating to the Aspen anesthesia divestment that was completed in the quarter. Turning to the top line.
This quarter again saw all three businesses contributing to our growth. Sales within the Pharma business were up 4%, despite a drag of nearly 1.5% from the Aspen and Romania distribution divestments. Growth from new products significantly offset declines in sales of older products in the portfolio.
Within our Respiratory portfolio, growth of the new products, the Ellipta products and Nucala, more than offset the decline in Seretide/Advair, helping to deliver global Respiratory sales growth of 5%. The Ellipta products have continued to achieve solid market share gains with the global rollout continuing. In the U.S.
in particular, at the end of Q1 Breo had a 22.7% share of new-to-brand prescriptions, up from 14.7% for the same point last year. While Anoro's share has risen from 13.8% to 21% over the same period.
Reported sales growth rates in the quarter for the Ellipta products were adversely impacted by inventory reductions in the quarter within the channel, as well as some unfavorable RAR [returns and rebates] adjustments. However, across Respiratory as a whole, the RAR adjustments were broadly neutral with offsetting adjustments in Advair.
We continue to see more fluctuation in RAR rates and the resulting provisions that we need to take than we did historically, reflecting the more competitive and dynamic market conditions in the U.S. And I'm not expecting this to change going forward.
We're very pleased with the progress of Nucala, which is now being taken by over 10,000 patients in the U.S. alone and has grown the severe asthma market by 33%. In Europe, Nucala is also gaining traction with strong performances in Germany, Belgium, and the Netherlands. And we're in the early stages of launching in many other markets.
We continue to prepare for the launch of our closed triple, which is on track for a potential approval later this year. While we remain confident in the long term prospects for this key addition to the Ellipta portfolio, as we've flagged before, it will take some time to build in today's markets. And so we don't expect significant sales before 2018.
And we expect a steady progression as we move beyond the initial launch phase. On Seretide/Advair specifically, if there is no substitutable generic entry in the U.S., then we continue to expect a decline of 15% to 20% globally, similar to the trend of last couple of years, with the U.S.
in line with this range, but Europe probably more at the 20% end, given the different stage of transition in our portfolio. As we've said before, if there is a substitutable generic in the U.S. during the year, then we'd expect a much steeper decline as reflected in our overall guidance. Moving to the HIV portfolio.
We continue to see global growth driven by the continued increase in market shares for Triumeq and Tivicay. This growth is more than offsetting the decline in Epzicom, which is now encountering generic competition in the U.S., but also across most of Europe. Overall, our HIV portfolio grew at 19% during the quarter. In the U.S.
dolutegravir remains the number one core agent. We're 24% of the STR in core Asian markets with more than 30,000 scripts per week. NBRx shares also remain encouraging at around 30%. The new grouping of established Pharmaceuticals includes the previous established products, CVMU and other Pharma products.
The new grouping includes most of our off patent products and declined by 6% in Q1.
The combined mix of this new grouping is likely to continue to decline at a similar mid to high single digit rate for 2017, including the drag from Aspen and Romania disposals, which represented a headwind of around £50 million in the quarter and for the full year will be just over £200 million. Moving to Vaccines, sales were up 16%.
This reflects a continued strong performance from the meningitis portfolio and improvements in supply from some of the investments we've been making.
It also reflects an element of phasing relating to the timing of international tenders, including GAVI's Synflorix sales as well as CDC purchases and stockpile movements that boosted particularly Pediarix's growth in the U.S. Excluding that, those phasing benefits, Vaccines growth would have been more in the high single digit range in Q1.
While Vaccine sales are often lumpy, the momentum in the business continues to give us confidence in the mid to high single digit outlook for the business over the medium term. However, remember that 2016 saw 12% pro forma growth, which creates a tougher comparator for 2017 as a whole.
In addition, I expect Q2 to see a reversal of much of the phasing benefit we saw in Q1, as well as the impact of a couple of competitors returning in our established Vaccines portfolio that have recently returned to full supply. Further ahead, we continue to expect regulatory decisions on Shingrix in the U.S. and Europe in Q4 2017.
We're excited about the prospects for this product, and launch preparations are underway. But as with closed triple, we do not expect meaningful contributions from Shingrix until we get into 2018 and beyond. Turning to Consumer, sales were up 2% after a 1% drag from the divestment of the Nigeria drinks business at the end of Q3 last year.
Strong results from oral health were partially offset by a more challenging quarter in wellness, where the pain category was up against a tough comparator. There was also tougher private label competition to Flonase. And despite an encouraging initial uptake of our new switch Sensimist, the allergy season is yet to kick in in scale.
We've also seen some slowing in a number of emerging markets as a result of general economic conditions. India in particular remains difficult, even though the demonetization disruption is now largely past, with tough competition still a feature of the nutrition category.
We continue to plan for the introduction of GST, which will likely cause another round of disruption later in the year. But despite these challenges, we delivered strong performances in many parts of the business, including strong growth for the power brands overall. And around 15% of all sales came from innovation launched in last three years.
Looking ahead for 2017 and beyond, we continue to expect this business to deliver medium term growth in the mid-single digit range.
As I've said previously, we expect to be down a notch from this range in 2017 in part due to the Nigerian divestment but also the more difficult conditions in India and international more broadly that I've already discussed. Turning to operating profit.
Our adjusted margin of 26.8% was up 230 basis points, 130 basis points from currency and a 100 basis point improvement at constant exchange rates from operational performance.
This was driven by leverage from sales growth in Pharma and Vaccines in particular, combined with continued tight management of our costs as well as benefits from restructuring and integration. R&D costs were up 8%, reflecting increased investments in Pharma R&D, offset by continued integration benefits in Vaccines and Consumer.
We saw a particular step-up in HIV, including late stage spend around the two drug regimens and the inclusion of the costs of the BMS assets acquired at the end of February last year. We also continue to advance our earlier pipeline particularly in oncology.
Subject to how the data progresses, we are expecting to continue to invest behind the next wave of the Pharma pipeline this year. Royalties were down 15% due to a previously flagged true up in Vaccines last year. We continue to expect around £300 million in royalties for full year.
And for Pharma as a business, the margin of 34.4% is up 50 basis points on a constant currency basis with sales leverage, a favorable product mix, and tight cost control more than offsetting the increased investment in R&D.
For Vaccines the margin of 29.6% is up 150 basis points, as the benefits of the 16% sales growth more than offset some incremental investment we're already starting to make behind the planned launch of Shingrix and the lower royalties. I expect Q2 margins to be lower than Q1 this year as the phasing of sales unwinds.
On Consumer the margin of 17.2% was down 80 basis points in constant currencies. This is in large part because of less top line leverage and the heavier phasing of A&P investment in Q1 this year versus last. We remain confident in the medium term trajectory of the Consumer margin, including the plus 20% target by 2020.
As we previously stated, accelerating the delivery of the targeted benefits of the integration and restructuring program was a key objective when we closed the Novartis transaction. And we're pleased with the progress we've made.
We delivered another £200 million of incremental benefits in the quarter with currency adding a further £100 million, for total additional benefits of £300 million. We've now delivered in full the originally targeted £3 billion of annual savings before currency, which has added a total of £0.3 billion to that for £3.3 billion in total.
This is well ahead of schedule with costs to date also lower than planned of £3.9 billion. Cash charges to date of £3.1 billion, having charged in the quarter around £150 million of the additional cash charges of £300 million that we said at the year end, we expected to make during 2017.
We are continuing to evaluate the program for any incremental savings opportunities. And we will update you on this later in the year. Turning to the bottom half of the P&L, interest costs were slightly up due to higher net debt in line with our expectations. The tax rate of 22% reflects the increased proportion of earnings in the U.S.
And we continue to expect to be in the 21% to 22% range for 2017 as a whole. Minorities also up reflecting growth in the Consumer and HIV joint ventures. Our cash flow and net debt reported free cash flow for the group was £650 million, significantly improved on the outflow of £240 million we saw in Q1 last year.
As well as the net benefit of FX, this reflects the improved operating performance across the group, a wind down in restructuring costs, continued focus on the management of working capital and CapEx, even as we build inventory for the expected launches later this year and invest in capacity.
It also reflects the impact on last year of the costs of the BMS HIV assets, which we completed in Q1 2016 for a cost of £221 million. Net debt now stands at £13.7 billion, slightly below where it was at the end of 2016, primarily reflecting the balance of free cash flow and net disposal proceeds versus our dividend payments in the quarter.
So inclusion, an encouraging start to 2017. The outlook for the full year still depends on whether Advair encounters substitutable generic competition in the U.S. At this point in time, as Emma has said, there still remains considerable uncertainty as to the timing of a possible introduction of a substitutable generic.
And so we see no reason to change the range of our guidance scenarios for the full year at this stage. We will update you as and when we have more clarity.
Our focus on execution is underpinning the progress we've made in the quarter, including delivering sales growth across all three businesses, improving the group's operating margin while still investing in each of those businesses, and also contributing significant improvement in our cash generation to support future investments and sustainable returns to shareholders.
We continue to expect to return an 80p dividend for 2017 and today the board has approved the first 19p interim payment. And with that I'll hand you back to Emma..
Thanks very much, Simon. So we're now going to open up for Q&A. As I've already said, we are going to be providing you with more detail on our longer term priorities in Q2. So with that in mind we would really appreciate it if you could focus your attention and your questions today on our Q1 performance..
Thank you. Ladies and gentlemen, your question-and-answer session will now begin. And your first question comes from the line of Graham Parry, Bank of America Merrill Lynch. Please go ahead..
Great. Thanks for taking my questions. So if I can kick off with Respiratory and HIV, which both grew in the U.S.
slower than prescriptions due to the rebate pressure and inventory movements, can you just help us understand how much of that was price or rebating and how much was inventory, especially in Breo and Triumeq? And if you're seeing any impact on Triumeq of a shift back to constituent products with generic capsicum being available now? And then secondly, a slightly bigger picture question for Emma.
I know we're going to get an update later in the year. But in the release she did reiterate the group strategy and outlook referenced, the prior 2015 to 2020 guidance given at the analyst's day back in 2015. So can we take that as some sort of confirmation that no big strategic shifts are anticipated under your new leadership? Thank you..
Thank you very much, Graham. So look, I will make comment on third question first. And then I'll ask Simon to comment on the detail of the Respiratory numbers, and maybe David to talk about HIV. So in terms of bigger picture, I think I should kind of reiterate really what I said in my opening words and then more detail to come in July as you said.
In terms of the structure of the group we do see both logic and benefit in being a three business health care company. Not least because of some of the uncertainty and volatility that we see in the high return still Pharma business. We like to have more certainty in terms of reliable cash flows both from Vaccines and Consumer.
We believe in some of the synergies both from an operating point of view and a life cycle management point of view when we look at kind of switches.
Or you could take the example of the Shingrix launch that will be upcoming in terms of – that obviously will be launched into HCP, but it's also going be a key vaccine that's distributed through retailers and with a direct-to-consumer communication. So we see that logic, as long as all three businesses continue to perform competitively.
So I think in terms of the structure of the company, I would confirm that. But it's something we should continue to review, hopefully not every quarter, but on a reasonably regular basis. And we're always listening to shareholders on that. The other two main priorities you should expect are absolutely near term.
A focus on execution, because we know we've got to continue to cement in confidence in our delivery after – on over a longer term five-year track record. Perhaps less competitive performance, but we know that's coming back up and we want to cement that.
Vetting in recent launches in new products you referred to, but also really preparing fantastically competitive launches for the few near-term launches that we do have, including in our core therapy areas of Respiratory and HIV.
And then obviously the really big priority where we create the most value in the company is in terms of the strength of our pipeline and making sure we have competitive new launches that really make a – bring meaningful value for patients and payers and therefore shareholders. So you'll get more on that in the summer in terms of the content.
Let me go perhaps to Simon first for a bit more detail on your Respiratory question.
Simon?.
Thanks, Graham. I think in the quarter, without getting into the sort of specific splits product by product, we are seeing quite a significant impact from destocking in both wholesale and retail channels, so more than we normally would see, which is why we called it out.
I think on the pricing side, yeah, we continue to see pressure in the marketplace. That varies quarter-to-quarter, which is some of the fluctuation that I called out in my comments. And I think you should expect that going forward.
Certainly, the back end of last year we saw some positive true-ups in some quarters, some negative true-ups in other quarters. So I don't think there's any major change on the pricing environment. More just compounded by a reasonable amount of destocking.
And that applied across the whole Respiratory portfolio and obviously had the effect that you've seen in the numbers..
David?.
Yes, Graham, so on HIV, I think actually the quarter was very much in line with our expectations. Dolutegravir overall was up 43%, of which Triumeq was actually 45% CER and Tivicay 41%. As Simon said, we were impacted a little bit by inventory and at the margin also by RAR.
But I should emphasize that was really just Medicaid true-ups and nothing structural or different in our approach on pricing. I think more importantly, the market share trends all look very robust. We don't see any real change in the mix of the business.
As I think Simon referred to, we're now up to about 30,000 weekly scripts for dolutegravir, of which Triumeq is around 16,000 and Tivicay 14,000. And actually the key indicator I really look at is what we call core plus STR market share. So these are all the third agent integrases, proteases, and in RTIs, plus their combinations.
And there we're at 24%. We are the leader. We are the leading integrase. We are a few points ahead of our nearest competitor. And actually that gap has been very, very stable over the last 12 months. So we feel good about that.
And our lead indicator on NBRx, we are around 30% for both naive patients, which is obviously important, and also our switch patients. And actually if you exclude the tenofovir to TAF conversions, we're probably closer to 40% on switch. So I think overall pretty solid. That said, it obviously remains a very competitive marketplace.
And I suppose the difference now is for our main competitor, HIV has become again their major growth driver. So there's no doubt the competitive intensity is not going down. But overall I think we're pleased with the start we've had this year..
Thanks. So thank you, Graham, for the question. Next question, please..
Thank you. And the next question comes from the line of Richard Parkes of Deutsche Bank. Please proceed..
Hi. Thanks for taking my questions. Firstly, just on Respiratory. We've seen Teva launch its Advair analog with a simultaneous launch of an AB rated generic.
So I'm just wondering what you feel the impact of that might be on formulary discussions and position, in particular in a scenario I think if generic Advair is delayed further? And then secondly, I just wondered if you could update us on your interactions with the agency over the Shingrix filing? I suppose I'm interested if the questions have been in line with your expectations? And if there's any indication of likelihood of a panel, given the novel adjuvant used? Thanks..
Okay. Thanks, Richard, for your questions. So just on the news from Teva. Just remind everyone that this is not a substitutable for Advair without a prescription. So it's a very different product with different mechanism, different dose. So we are much more focused on when a generic Advair might come through. Obviously we had the recent news from Mylan.
But we don't know exactly what kind of delay they are facing. We also have Hikma coming up. So that's absolutely why we've reiterated our guidance for the year, which you will remember assumed at the bottom end a midyear arrival for generic Advair. And we have no new news on that. But the really important thing is here, we're ready.
This is something the business is prepared for and we're very focused, to Graham's earlier question, on building out our Ellipta portfolio. In terms of Shingrix I don't really want to comment on our engagement with the FDA.
This is obviously a really important launch for us, which we hope we'll be able to demonstrate really differentiated efficacy in the market, also on a sustained basis. We have shared today in our results some positive results in terms of the ZOSTER-048 study against those that were previously vaccinated.
And that will be shared more in the ASEP – sorry, June at ACIP. But that's as far as I'd go on that topic today. So thank you very much, Richard. And then to the next question, please..
Thank you. The next question comes from the line of Jo Walton of Credit Suisse. Please go ahead..
Thank you. Three quick ones. Firstly, on the Consumer business you've highlighted the weakness particularly in the international markets. I'd welcome your perspective on when you think that that will ease? And when we might see an improvement in that market? Secondly, established products. As a group that's a very large part of your overall portfolio.
It declined at local currency at 6% in the quarter. I wonder if you could comment on just how profitable that unit is. Presumably it's got pretty minimal promotion behind it, very well established, well known products. So we should assume that that is very profitable.
Is that rate of decline of 6% realistic as a longer term rate of decline? And finally, a quick question on cost savings. We now know that we've had all of the cost savings delivered. But presumably you've just finished some aspects of restructuring that haven't yet given us all of the cost savings.
So if you do nothing more, but you just let those come through, how much more cost savings will we see by the end of this year? Many thanks..
Thanks, Jo. I think all three of those questions are going to go over to Simon for the response..
Thanks, Jo. So on the Consumer business, I think as we move through the course of the year, we are expecting improvements in the Indian position. We talked about the demonetization effect.
The performance in India being driven in the core of the business by the Horlicks brand and a number of innovations and launches planned for later this year, which should see that pick up performance. But the broader macro conditions, if you like, in the emerging markets still remain tough.
So I think a note of caution in terms of how far, much further forward. And remember also we've got a drag from the Nigerian drinks disposal, which will wash out after Q3. So we should see in the second half of the year a bit better performance than we've seen so far. But it does remain challenging.
On the new established Pharmaceuticals grouping, we really put those together, given that we run them together. They are off-patent products largely. You're right that they have relatively lower promotional support as you would expect, given the stage in their life cycle. And so they are strong profit contributors.
And this is why in the past when people have asked, well, should we sell those or dispose of them? That actually they're worth more to us than to anyone outside the company in terms of what they contribute to cash flow and margin. I'm not going to get into a breakdown between individual product categories.
But they contribute as you would expect for products at this stage in their life cycle and meaningfully in cash terms as well. So what we're going to do going forward is give a bit more color in terms of the individual elements of that or the kind of categories within that. But we'll update you some more on that at Q2.
But this is a group that we do run together. And going forward from a trend point of view, I think mid to high single digits is the right sort of territory, and that's what you should model in. Now it's obviously got some drag from disposals in for this year.
But it is a portfolio where I think you should continue to expect us to make disposals if we can identify particular pockets of value where that makes sense. And so that's probably the right continuing trend to factor in as well. And then on cost savings.
As I said in my remarks, our experience has been exactly as you point out, that we do get additional benefits over time as we complete the programs. We're only just coming to the end. So we're looking at where we think we can really squeeze additional out of those.
And where we should really focus, and what's going to contribute most effectively to the business. A bit early to say that. We'll update you during the course of the year, so bear with us on that.
But certainly I think you're right that to expect continuing flexibility in our cost phase going forward, which has served us well so far, as we reallocate resources behind both the new product and the pipeline, allowing our SG&A in constant currency terms to stay broadly flat and restrain some of the growth that I know some of you were worried about a while ago.
Hopefully that answers your questions. I'll hand that back to Emma..
Thanks, Simon. And just to reiterate, beyond any kind of update on restructuring programs, it's something that Simon and I are discussing a lot and with the leadership team, a much more disciplined focus on general running costs and cash consciousness across the whole company in an increasingly tough external environment as we've discussed. Okay.
Thank you very much, Jo, and then on to the next question, please..
Thank you. The next question comes from the line of Andrew Baum of Citi. Please go ahead..
Andrew, hello?.
Hi, yes, it's Andrew. Sorry, I was on mute, apologies..
No problem..
Couple of questions, please. The newly appointed CEO of Lilly, who also has a long tenure at that company, indicated that he sees opportunities that materially increase the tension and accountability in that organization that's driving that execution in that shareholder value equation.
Does that resonate at all, given your background both at your previous company and then in the last seven years or so at GSK? And then second, you highlighted in your comments the addition of Luke to the team to better align Commercial with R&D.
In terms of thinking about the ROI for your development pipeline, do you believe there's additional opportunities for pruning the existing pipeline that intensifying capital allocation on a few of key assets compared what has happened historically? Thank you..
Thanks very much, Andrew, for both of your questions. In a moment we'll come into the pipeline one. And I'm going to ask Patrick, who is here with us here today as well, to talk about focus and disciplined choices there. Though obviously, we'll be updating you more on that in the Q2 results, update it in July.
And clearly Luke is going be a very important addition to that team in partnership with Patrick to really put that discipline in terms of our governance around the development programs and who should be with us in due course. I would like to comment on – and thank you for your question – around I suppose some more cultural aspects.
And absolutely, I do recognize that comment. I think – and it's something that in my kind of first week with my leadership team around me, we spent several days really talking about what we want the culture to be at GSK, what we want to keep. Because I've been talking over the last few months to thousands of people inside and outside the company.
And there's a lot that is very precious, particularly in terms of the underpinning of the values of the company aligned to the purpose of fundamentally what we're here to do in terms of the impact on human health.
But there is an opportunity to put more discipline, more performance orientation, make tougher choices, be much more explicit about individual accountabilities, and standardize some of our metrics, simplify some of our ways of working. Very easy thing to say; not an easy thing to do in a big matrixed organization.
But it starts with alignment at the top. And it starts with the tone you set at the top. And we've had some really constructive focused discussions on that, which I'm delighted to share with you in more detail in the future. But I absolutely recognize that. And I think, yeah, culture is an undervalued competitive advantage.
So, Patrick, can I send that over to you in terms of how we think about the discipline around our portfolio, please?.
Sure. So hi, Andrew. I mean I think the short answer to your question is yes. There is absolutely room to improve that.
And not only is there room, but there's a necessity, because of the quality and novelty of some of the things coming through that we absolutely need to back with the appropriate level of resource to get them through fast and to the end. So historically I think we have let some things circle too much.
We had some legacy products, which I think continued too long. We've done some cleanup. We've got some more cleanup to do on that. And the cleanup is absolutely essential in order to be able to really back the winners that we think we've got coming through.
And to make sure we do some – do so with the right level of organizational might, the right resource behind it, and the right alignment behind it. So I think there is an opportunity to do that. We'll say more about it. You know that we've got some exciting things coming through.
And I think the alignment between R&D and commercial in this is going be crucially important to make sure that we get that pull through as effective as we possibly can, so that we don't have any divide as we accelerate some of the things that we're interested in pursuing..
Thank you very much, Andrew.
So could we move to the next question, please?.
Thank you. The next question comes from the line of Tim Anderson of Bernstein. Please go ahead..
Thank you. Couple of questions, please.
Any updated perspective on the coming competition in the integrase inhibitor space with Gilead's product, head to head data coming out in 2017? Wondering if you have any insights or best guesses as to what that data might show versus dolutegravir in terms of profile? How it might be either better or worse? And then on Advair, from what I understand you may have an authorized generic ready to go in the U.S.
Once true generics launch, that would capture some of the value of the generic channel. And I'm wondering if you can confirm if this is the case? If it is, it makes me think that the 2017 guidance in the lesser of the two scenarios that you've outlined could possibly end up being better than your describe? Thank you..
Thanks very much, Tim. Obviously I'll come to David in a moment on the question in terms of Gilead's upcoming results, although I don't think we're in a position to guess at what their data might bring. But I'm sure he'll have some comment and insight on what we've seen so far. Just in terms of your question around the kind of Advair program.
I'm not going to comment on the specifics of our plan, because that would obviously be very competitively sensitive. But we have been preparing for this for some time. And when it comes we'll be ready with a diverse set of actions and opportunities that we can pursue. We are absolutely maintaining our guidance, because we don't know any more.
Just because of the recent announcement around delays, we don't know yet what's going to land, as I've already iterated. So we're maintaining guidance as it is. So, David, over to you.
Any further comments on the competitive situation in our priority category of HIV?.
Yes. So, Tim, we don't have any insight obviously at this point as to what the Phase III data may look like. Along with everyone else, we've only seen the Phase II data, which was in less than 100 patients. And I think just 33 patients actually on the dolutegravir arm.
I think the general consensus around that data is that bictegravir looks broadly equivalent with dolutegravir. But of course it's limited data and it's early. So we really need to see the Phase III data this year. And what would be important in that is obviously the primary end point on efficacy.
But also detail on things like drug interactions and whether they're dosed, because the dose in Phase III is different from the Phase II dosing, whether that has any material difference. But we'll see how that plays through later in the year. Against that I'd remind you, dolutegravir, we've now started it for over 10 years.
We have 300,000 patients-plus worldwide on the medicine. Over 120,000 in the U.S. We've done a very extensive clinical program over those 10 years. Five Phase III trials prior to registration. A very extensive Phase III b4 program in all sorts of different types of patients, women, co-infected with TB, and so forth.
Four of those trials showed superiority against the standard of care. And I think it's very clear, patients and with physicians, dolutegravir is seen as a potent, very well tolerated, and I think importantly, very high resistance barrier medicine.
We've seen no emergent resistance at all from dolutegravir mutations in any of the clinical trials when the patient received dolutegravir as an initial therapy. And of course it's that data and that profile that's really leading us into the dual therapy. So we'll see what the competitors do later in the year. But we feel we're in a very good position.
We've set the bar very high. And dolutegravir is going be a very important medicine going forward..
David, thanks very much. So, Tim, hopefully that answers your questions. Thank you for it. And over to the next question, please..
Thank you. The next question comes from the line of Kerry Holford, Exane BNP. Please go ahead..
Thank you. Two questions, please. Firstly, on U.S. corporate tax. So just would be interested in your views.
If Trump's proposed tax reforms are enacted, how could we envisage the GSK group tax rates evolve over time? And specifically if you're willing to comment, what would be the sensitivity to that 15% proposed corporate tax rate and the impact on your group tax rate of 21% to 22%? And then secondly on Vaccines. Simon, I know you touched on it.
But I'm not sure I caught all the details. To the benefits from CDC purchases and stocking patterns this quarter, how should we think about those as you move through the remainder of the year? What phase is a sensible constant currency rate to look for for the full year? Thank you..
Thanks very much, Kerry. So I'll pass on both of those questions to Simon. But just to reiterate, and maybe we'll get some news from the House or from the President later on today on tax. But it's still very uncertain what exactly is going to come out here, just as it is on various aspects of potential impact in the U.S.
environment, whether it's on the American Health Care Act or on tax reform or on potential regulatory reform, which might be positive as well in terms of accelerating innovation. So we'll see on tax. Simon will add some additional comment. We hope it will be mildly positive over time. But perhaps, Simon, you can add on that.
And then add your commentary and reiteration on the Vaccines..
Yeah. Thanks, Kerry. I mean as you point out, it's still very unclear really as to what proposals might firstly emerge and then actually get passed. And the House is in a different place from where it is rumored that the President is.
If a headline reduction in the rate is all that we see, clearly you would expect that to have a significantly positive benefit in terms of reducing our tax rate going forward. But there's an important caveat in there.
How interest deductibility works or whether – and whether in particular there's a border tax is a key determinant of the final impact on a group like us, where we have a lot of investment and a lot of employees and a lot of activity in the U.S., but we do import API, vaccines.
Very difficult to move primary production from where it is currently, mainly in Belgium. So there will be some things for us to manage. On balance however, today, from what we can see of the multiple options in front of us, it looks like it will be on balance positive, a small positive. And let's see kind of what the detail reveals.
But as we learn more, we'll try and keep you updated. But it's that side of the line probably. On Vaccines I think as I said at the end of last year, with the full year results we have a medium term view of that business of a mid to high single digit top line growth. We grew 12% in 2016.
And so 2017 has a tough comparator and probably is going to be more at the lower end of that range. The phasing that I talked about in Q1 will pretty much unwind in Q2.
So if we're high single digits without the phasing, you can reverse that back out in Q2, which is why I've just alerted you to the leverage effect and the impact that's likely to have on the margin, given that we want to keep investing behind Shingrix and the program that's coming to support that.
And that's obviously a key launch for the group going forward. So I think if you think for 2017 as a whole, you have the lower end of that mid to high range. Obviously we've also got a tough comparator with flu coming up in Q3. So continuing to be lumpy quarter to quarter, but that probably gives you a guide as to the endpoint for the year..
Thanks very much, Simon. Kerry, hopefully that answers your questions. Next question, please..
Next question comes from the line of Michael Leuchten of UBS. Please go ahead..
Thank you. Two questions, please. One, going back to the HIV business, the ViiV business for Triumeq and Tivicay, and just thinking about it sequentially there, there does seem to be a slowdown in Q1 that isn't entirely explained by the volume trends? And if I got your comments right, pricing really wasn't a benefactor.
Is that stepdown entirely related into the inventory moves that you mentioned on Triumeq? Or is this market more dynamic than maybe it had been over the previous quarters? And then the second question. Luke has come up a couple of times now. I think you've just said in due course he will start at – I thought his starting date was in April.
So it sounds like he hasn't joined the company yet.
Given your Q2 update in terms of the strategy going forward, at what point do you expect him to be with the company? And then has he been part of discussions so far in your strategic outlook? Or has he not?.
Thanks very much, Michael. So I'll pass the HIV question back to David in a second. But just to comment on Luke, you're right, he hasn't joined the company yet. We're still in discussion with his previous employer. And I hope we will get to some resolution on that, and he'll be able to join the company as soon as possible.
David, do you want to answer anything?.
Yeah, so I don't really have a lot to add, Michael. I mean I don't think we do see any slowdown. As I talked about, the prescription trends are remarkably consistent for both Tivicay and Triumeq. Triumeq grew 45% up to 16,000. That's very much on the progression that we expected.
There was – I'd put more emphasis on the inventory destocking really than RAR. There was some RAR true-up, but that was generally in the U.S. market and across the whole business in inventory. And the ViiV business is distributed with the rest of GSK. So there was some impact there. It's at the margin.
But overall, I think the growth trends are consistent..
Thanks, David. Next question, please..
The next question comes from the line of James Gordon of JPMorgan. Please go ahead..
Hello. Thanks for taking the two questions. One question was on the pipeline. We've heard you talk about the excitement around the approval decisions coming up in the next 12 months.
But in terms of products that are still in the clinic, are your hands totally full with internal assets that you're excited about? Or are you also currently on the lookout for potential external assets as well? And the second question was just about reviewing priorities in conjunction with the Q2 results.
So it's going to be a bit more than two years since the 2020 targets were set, and almost two years since the pipeline deep-dive last took place, So would it be reasonable to expect an update in terms of 2020 targets or beyond? And like a deep pipeline dive at Q2 as well?.
Okay. Thanks very much, James. So a deeper pipeline dive, definitely, I think we could be updating. You'll have a chance to hear on all of the three businesses in more detail. But certainly there will be a strong focus on Pharma, particularly with Patrick. In terms of any guidance commentary, wait and see, I think is the answer to that.
And we'll update you then. And then full pipeline. I think just very briefly, of course we will be looking. We're looking at what we've got internally. We'll be seeing the data as it comes through, really important data over the next kind of couple of years really.
We hope that, as Patrick has already said, we'll be able to double down on some exciting assets there. But we'll be looking externally.
And right at one of the earliest questions today in terms of kind of any M&A focus, it really is on the early stage pipeline to make sure that we are bringing a competitive portfolio of scaled new medicines for patients and payers. And that will include internal and external sourcing. Thank you. Next question, please..
The next question comes from the line of Seamus Fernandez of Leerink. Please go ahead..
Thanks very much for the question. So a couple of questions. Emma, as we think about the prospects for Consumer assets potentially coming to market, obviously there's been some commentary there about some large potential Consumer assets either going up for sale or perhaps getting creative with financial structures.
Do you think that that is a possibility for GSK to participate in those types of discussions and to fully finance? Or would you be more interested in a creative structuring of partnerships as you have in the past? And then the second question. I don't think that a question has been asked on the triple.
But in terms of the triple, maybe you could just talk about the opportunity to broaden and expand the opportunity for the Ellipta franchise within the context of the Respiratory business? Thanks so much..
Okay. So thank you. In terms of Consumer, I mean we do think that's interesting. And we have said previously that we've structured the JV to allow potential further consolidation in the industry, which we'd like to be part of to a degree. Obviously the put is the first question on the agenda for that, which we continue to express interest in.
But that's Joe's choice. And we keep an eye as a leader in the Consumer Healthcare sector. We actually keep an eye on what's out there. But we're very focused on making sure that any options create shareholder value. I'm going to ask Patrick to perhaps come back further on the opportunity within the Respiratory franchise.
We are excited about triple, because at the moment there are 22% of people in COPD, who are currently on the open triple. And we do think with a once-a-day medicine in a device that will allow also people to graduate through the different GSK medicines, so definitely opportunities in there.
But we have broader opportunities across the Respiratory franchise that perhaps Patrick would like to comment on as well..
Yeah. So I mean we – obviously triple, closed triple we expect to be important and for the reasons Emma has said. People moving from open to closed and the convenience of that. The Ellipta portfolio allows people to move up and down as they need to between treatments without having to change device and learn new device.
New inhaled medicines that we bring along will fit into the Ellipta device. So there's very clearly a plan there in terms of how that fits. We're expecting data on the – from the IMPACT study later this year. And of course that will cement where triple fits in versus dual as well – closed triple.
The guidelines we expect to move in the direction of use of triple. And we're also looking at triple in asthma. So we expect there to be quite a broad opportunity both around the Ellipta platform per se, and also triple specifically in terms of its impact in patients with COPD and, when we get the results, potentially in asthma as well..
Thanks very much, Patrick. Okay. I think we're now going to have time for one last question. Or two or three last questions within one last question..
And the question comes from the line of Vincent Meunier of Morgan Stanley. Please go ahead..
Thank you very much for taking my question. Actually it's on the cost base. The gross margin first came slightly better than expected. So do you think the Q1 level to be sustainable for the remaining of the year? And if there being the case of no U.S.
generic of Advair? And more generally, how would you see the cost base evolve for the rest of 2017 and maybe 2018 in terms of R&D spending and SG&A in the context of the strategic review? Thank you..
Thanks very much, Vincent. So I'm going pass that question onto Simon, although obviously in terms of longer term point of view, you would expect more of an update on that in Q2.
But, Simon, do you want to make any comment?.
Absolutely, yeah. You're absolutely right. The gross margin was a bit better in the first quarter. And as we called out in some of the commentary in the release, that really reflects mix as well as obviously kind of leverage at the top line.
So I think we're seeing continued progress in that, together with the contributions from the balance of the restructuring and integration programs, which in the quarter fell particularly to the benefit of the manufacturing and supply chain activities, so have benefited the gross margin more than other lines.
I think on the rest of the cost base, importantly as we've said before, we're going to manage the P&L to make sure that we're investing in the right places to drive the most sustainable and most attractive growth going forward and work that through the whole P&L to drive earnings per share faster than that top line.
And the individual line items are going to move around to deliver that. So we'll give you the guidance with that context in mind. I've said before we continue to focus on keeping SG&A tight, growing behind sales, delivering leverage into the P&L.
We're making sure we're backing the new products that are allowing us that flexibility to step-up the R&D spend as the pipeline progresses. And I think you've seen that in the quarter where SG&A is broadly flat and in constant currency terms.
And we'll be very focused on protecting that flexibility on the back of the restructuring that we've been doing over last two, three years and going forward. So hopefully that helps you for now. We'll give you some more updates as we move through the year..
Thanks very much, Simon, and to all of the team. So just to reiterate, we do think this is a positive start to the year for GSK. But it's important that we now continue to deliver reliable performance for the rest of 2017. So with that I'd like to say thank you to all of you for your questions.
Again I'm looking forward to seeing more of you in the quarters to come. And of course, all of the IR team are absolutely available here at GSK with any follow-up questions you might have. Please do feel free to do so. And we'll help you as best we can. Thank you very much..