GSK plc (GSK) Earnings Call Transcript & Summary
January 6, 2022
Earnings Call Speaker Segments
Keyur Parekh
analystGood morning, Happy New Year, and thank you all for joining us. My name is Keyur Parekh, and I cover the European biopharma names for Goldman Sachs. It's my pleasure to welcome Emma Walmsley, CEO of Glaxo for this conversation. Emma, thank you so much for taking your time and for joining us. We really appreciate it.
Emma Walmsley
executiveWell, it's wonderful to be here, a very happy new year to you, Keyur, on behalf of GSK. I'll get you to move on from the Glaxo words. And a hugely happy new year to everybody who's either joining the video or listening later. I hope it's a healthy, happy and impactful one for you all.
Keyur Parekh
analystEmma, I don't want to spend a lot of time talking through Glaxo -- GSK and kind of the various moving parts of the business. But if we kind of start at a 30,000-foot industry level, lots of kind of big things happening in the industry, be it kind of pricing U.S., China, be it kind of use of AI, be it biotech funding, et cetera. So, just as kind of the CEO of GSK, can you talk us through what you are excited about over the next 3 to 5 years for the broader industry and also things that kind of you are concerned about?
Emma Walmsley
executiveSure. Well, I would say on the net balance of excitement versus concern, I'm very much in the excitement space, not least because the GSK, this is going to be a landmark year. but also because I think, when you think about the decade of the '20s, which obviously started with an enormous global focus on health care issues in a very tragic and disruptive way, I actually think we're looking into an exceptionally exciting decade exactly, as you say, because of this momentous advances and fusions between our scientific understanding of biology and the huge capability acceleration and everything that's technology. Not just in the biosciences space, but just -- I speak as the CEO of GSK and a net of Microsoft, when you see what's happening in the tech sector and how these 2 things can unlock, ultimately, the biggest challenge for our sector, which is the productivity of R&D and then driving access and more global equity at a time that those topics have never mattered more. So, I'm full of optimism because, health is top of every family, company and country agenda, and there is still an enormous amount of unmet need in so many diseases with an aging population and a heavy burden of health care and there is a huge recognition of the primary value of prevention of disease and earlier into that germ, which obviously is great for those of us in the vaccination business. I also think that COVID is still very much here. I'm sure we'll come on to talk about the latest surges and the latest variants. But I do think there is a growing awareness on the adult vaccination space, as a result of this, and also -- and acute sensitivity to the indirect health consequences in many other areas that need focus in investments there, too. I think data and analytics and artificial intelligence, particularly when combined with the advances in science of genetics are going to allow us to unlock far more productivity in the full value chain of drug discovery, manufacturing, actually, and development. And then, of course, it comes to the distribution point. You think about what we've all learned through telemedicine in the last 2 years. You are seeing a shift in health care professionals expectations of how they interact both with suppliers and our field forces and medical reps, but also how they're working for patients and a huge surge in patient understanding and insight of their own disease management, which impacts all that we do. And then, I think 2 other things, which are not unique to our sector, but I think play to the incredible importance of our purpose as a sector and where GSK frankly, has long led the way, is the incredible acceleration of the ESG agenda in the broadest possible sense. We've always been a company that considers itself focused on multi stakeholder value creation. It's always been at the core of our strategy, and I hope more and more will be recognized by being at the core of our investment case, but that is an expectation that matters for building trust, reducing risk and, really, underpinning the positive social impact we have as an industry. And I think, differentially, for GSK as a company. And lastly, and this is a phenomenon in every sector, but anybody that leaves any company will know that it's all about talent. It's all about attracting and developing in the most exciting way possible, the best people in the world to help lead and deliver for shareholders and patients. And I think, every CEO, every company is very focused on what their value prop is for talent and very confident that GSK can continue to lead the way in fact 2 companies as we look forward on that space.
Keyur Parekh
analystEmma, just kind of pick up on something you said, which is kind of this interaction between kind of tech and big data and AI and advances in science kind of genetics. What do you think that means for the shape of the industry, kind of, on a 10-year view? Do you think biopharma companies will have to have, kind of, more expertise in big data? Do you think the players in the industry look different, kind of, in 10 years' time from a biopharma perspective? What do you think happens there?
Emma Walmsley
executiveWell, I think we're all recognizing, and this industry has always been more focused on the kind of ecosystem partnerships. Just look at the way business development has continued to evolve, and you're seeing more of a focus on platform technologies and capabilities as well as early assets licensing or bolt-ons as well. And I think, the answer is a whole hearted yes, that's exactly why GSK is focused on a strategy based on, of course, the science of immunology, the human science, but also genetics, which allows you to be much more predictive and improve the probability of success of drug discovery and development, but also technologies that are linked to that, such as AI and machine learning. We're investing very heavily in those capabilities. I think we will -- there's always going to be a role for the large-scale capabilities of companies like ours, as long as they are future facing in these capabilities as well, and are agile about the kind of partnerships they build as we have, with a variety of different academic institutions both in the U.S. and in the U.K., but also companies like 23andMe as well. So, of course, the industry will continue to evolve. It is survival of the fittest and GSK is really, really future facing on this, and this is a wonderful year to be starting that step change in delivery for all the investments we've made.
Keyur Parekh
analystSo, talking to that, I mean, the 12 months coming forward on GSK are probably going to be the most exciting 12 months since the formation of the company, kind of, back in the early 2000s, right? And you're going to have 2 separate companies. Just kind of bring us up to speed on your level of excitement for both the Consumer Health Business but also the new GSK and kind of what drives that?
Emma Walmsley
executiveWell, I think, it is -- '22 is a landmark year for us, because, as you say, GSK was formed in 2000. And what we've been working on so hard as a leadership team over the last 4.5 years is being -- is the -- all of that work is going to start to read out into a step change in delivery from this year, is unlocking tremendous value for shareholders, patients and our people, with 2 businesses that are set up for independent delivery of highly competitive growth and scale impact on human health. We have been -- on the GSK side, not comment on both, since 2017, really undertaken this radical transformation of the company across all of its different levers to address, frankly, some long-standing issues, which we know we needed to get at and have been a direct cause of historic underperformance. And those starts with, let's prioritize number one, R&D delivery. So, we've had a significant investment and increase in spend there. And I think, really, started to see the quantitative evidence of progress there, whether it's been 12 major approvals, which is, by any of the statistics we shared in June, a top quartile performance. We've doubled the number of potential new vaccines and medicines in late stage up to '23. We have a pipeline of over 60 assets, most of which are potential first or best-in-class. On commercial execution, under new leadership, we've had a major push. I remember, when starting this job, saying, we want to get 3 assets approved and really show that we could execute launches competitively, and those were Shingrix, 2-drug regimens in HIV and Trelegy. Now, all of those 3 have comfortably passed the GBP 1 billion mark in recent years. And with new policies, we've really shown how we can compete in -- and our new and specialty meds are now over GBP 10 billion in sales and our vaccines business has grown 35% since 2017. And so, real progress there and lots more to come with exciting launches coming up. We've had huge changes in the group structure, our portfolio, shifting majorly towards vaccines and specialty meds, which we think will be 3/4 of the business by 2026, which is important for margin regression, a 30% reduction in our manufacturing network with major implications around working capital there. A significant reduction in our business footprint and a focus on key markets and much better returns, major streamline of our supply chain, substantial cost savings with the final work through of our restructuring and noble plans in the outlook, which is great for the company, as well as for shareholders and for our people, ready to be focused on growth and lots of divestments of noncore assets. A new culture for accountability, ambition and always continuing to do the right thing. And of course, using the catalyst of the separation to reset the GSK balance sheet and unlock that Gordian knot there. With the transfer of debt to the consumer business, much more high-performing conversion to cash and, of course, a reset and progressive dividend as we look forward. So, for new GSK, we were really pleased to make new commitments to highly competitive growth starting from 2022 with more than 5% top line CAGR outlook in May for the 5 year, more than 10% bottom line, double-digit growth in specialty meds, high single-digit growth in vaccines. And most importantly, an outlook over the decade that's going to impact the lives of 2.5 billion people. So, we are raring to go for a new GSK, and 2022 is exciting in that sense. I must touch on Consumer Healthcare. That's a business that over the last decade, I've been absolutely thrilled to frankly create so much value with a dream team. The 2 largest deals and integrations in the sector and the creation of the world's only and first, dedicated to Consumer Health business, with sales over that time, more than doubling margins more than doubling and great growth prospects. We'll be announcing very soon the Capital Markets date which will be this quarter to give people a lot more visibility of this incredible portfolio of brands. Brian McNamara, a great partner for me than designate CEO; delighted to announce the new Chair, Dave Lewis thoroughly experienced retail and consumer goods experts on a global scale, who's obviously working hard on bringing together the Board and the new governance for that company and lots more to share there. Our goal here was always to prioritize shareholder value, strengthen the GSK balance sheet and unlock this incredibly exciting growth prospects. And now, after a lot of reshaping of that business, you're starting to see a clean read of the growth momentum, and it's got great prospects ahead. Really excited.
Keyur Parekh
analystAnd just to kind of make sure there's no changes on that time lines for the separation to remain very much, kind of, second half '22...
Emma Walmsley
executiveSummer.
Keyur Parekh
analystSummer '22.
Emma Walmsley
executiveYes. So, we're absolutely in count down mode. It is pretty impressive. I think that through the pandemic, the team managed to not miss a beat on this massive 100 country integration and preparation for separation. The timeline is in no way altered. We're still going for the summer, and we'll get more precise on that. As I said, we're going to announce, really soon, the date for the CMD. I'm hoping everybody will come and hear about the exciting prospects for these brands, that business, and the growth and sustainable competitive top line growth, sustainable progress in margin and, really, exciting prospects for that business and the impact it's going to have.
Keyur Parekh
analystAnd then lastly, kind of, before we move on to new GSK and specific kind of parts of it and you kind of referenced the contribution Glaxo have made to global health over the last, kind of, couple of decades, kind of, your focus on it at an individual level. What do you think lies next, kind of, for the industry as a whole? Obviously, one of the things you've seen with, kind of, COVID is the perceived inequality of vaccine distribution. What do you think, kind of, the industry needs to do better from an ESG perspective?
Emma Walmsley
executiveWell, I think, first of all, before we talk about all the things that the industry needs to do better, the industry has done a pretty laudable job over the last 2 years, to mobilize individually, but I think, most impressively, collectively in teamworks and in partnerships. It's extraordinary to see the pace of vaccine development, see the pace of treatment development. We're delighted to be contributing to that meaningfully. You may have noticed in our Q3 results, we were increasing, again, the contribution of those which seemed excluded from all of our guidance. The contribution from COVID solutions for another 7 to 9 points of EPS. And obviously, we're very heavily involved with the Omicron variant, at the moment, with Zevudi as well. And then, of course, there's the whole endemic contribution that's going to come from vaccines and boosters in the future. But I think the industry has really stepped up, including mobilizing for supply and it would probably be fair to say that the world is not going to be short of COVID vaccination in 2022, although obviously, there's -- who stands in the front of the queue and making sure that equity is sufficiently focused on in the early days, and I'm sure there will be lessons learned for next time or at least I hope there are, in terms of how that's all prioritized. I do think, every -- ESG has rocketed up the prioritization list for all stakeholders. Not least employees but also investors. And every sector has its, kind of, priority area. We all have to be responsible on the social, on the employee aspects. We will have to be responsible on the environment, but obviously, what is the key topic in our sector is around pricing and access and affordability and equity. And on this, I think there is growing recognition of that. I am -- GSK has an incredibly strong and long-standing history of absolute category leadership in this space. We have topped the Access to Medicines index every single year since it began. We are the biggest supplier to Gavi in terms of vaccines. We made one of the earliest commitments to access on vaccines around COVID vaccination, not least with the technology that we use to deploy and I hope we'll be able to contribute to that over the years to come. We topped the antimicrobial resistance, which is the slow pandemic that is going to come -- is emerging very strongly, and I think the industry has actually collaborated. And we're part of that, also to make sure that we can bring through new antibiotics. So, I think the sector is stepping up, but I'm very determined that also, as our TSR starts to deliver more and more, that we get the recognition of GSK for our leadership in access for our leadership in environment where we've committed to net zero and nature positive by 2030. We have very strong performance. Everyone can always keep doing better, but on diversity and inclusion, on our statistics, we've made new commitments on representation on both gender and on ethnicity for all our major markets. So, this is absolutely defining to who we are as a company and not least in that very purpose of impacting the health of 2.5 billion people over the decade ahead. So, I think the industry has stepped up, continues to step up, but I'm confident that GSK will lead the way on this.
Keyur Parekh
analystKind of moving on to the new GSK story. Obviously, a large part or a huge focus on, kind of, your HIV business. I think you've had a lot of, kind of, news flow in that, over the last 4 to 6 weeks, you've had approval for cabotegravir in, kind of, the prep setting, slightly ahead of expectations. At the same time, there's been some competitive news flow. So, just kind of bring us up to speed on how you're thinking about the opportunity for not just, kind of, cabotegravir, but also the deal regimens, longer term, as you kind of put all of those things together.
Emma Walmsley
executiveWell, I do think it merits some reflection on how -- we know we've had issues to address on our R&D productivity. But one of GSK's, and it's really important to recognize it as that, long-term repeated leadership areas, has been in HIV innovation, time and time again. Whether that has been with cabotegravir, with 2-drug regimens, and you will remember, Keyur, an enormous amount of skepticism as they surpass the GBP 1 billion mark and everybody in the industry is now focused on 2-drug regimens, because this fundamentally unlocks, not only an economic benefit for payers, but just the volume of drugs that someone who is living with this as a chronic disease. And we've been -- what they need to be able to take over a lifetime when they get parity to performance and without breakthrough of resistance. It's just been a tremendous success story. We've also pioneered in long-acting. And again, this was also where everybody called in with the recognition that as in many chronic disease states, having something that you don't need to be reminded of every day, but there can be an effective treatment or, indeed, this holy grail of prevention, is very exciting. So, I think we've continually pioneered. We've shown we can execute in one of the most competitive environments possible, commercially. And we're -- as Deborah and Kim laid out, both in June and then more recently, in an HIV update, we're excited about the emerging long-term pipeline as well, and we are confident that as a company, we're going to be able to digest the end of the decade patents, which, frankly, were meaningfully less exposed the many, but we're planning well ahead from that with our pipeline within HIV and beyond that. And the fact is, that you've got nearly, I think, 40 million people worldwide living with HIV and you're still getting nearly 2 million new cases every single year. PrEP, prevention of HIV, just so thrilled to get that approval just before the end of the year. That's a lovely Christmas present. And adding that to the treatment programs that you have. I think there's no question that this all starts to look towards, hopefully, the addressing of an ending of this epidemic, which we know the U.S. government, particularly, is very committed to doing and putting funding behind over the very near term, actually, with some goal set for '25 and for '30. And the great news is, we've got at least, when you refer to competitor news, I'll let them comment on it more, but we know we have at least a 5-year head start. We've always been very committed to the safety agenda. We'll keep an eye on what's going on there. But we've said we think long-acting could be a GBP 2 billion business by 2026. We do believe that's going to be the shift in the portfolio and including in our business development, whether it's more recently the Shionogi or the Halozyme work, we're continuing to invest in long-acting, too. Quite a bit challenging in the immediate context of, well, COVID's hair. And as you know, what's happened with the switch market, in terms of the update, but foundationally, the demand is absolutely there, and we're very confident that we are extremely well positioned to serve it.
Keyur Parekh
analystTalking of COVID, obviously, kind of, Omicron's slipping through a large part of the world. How do you see the impact of that, kind of, on your Vaccines business into '22, kind of, particularly as we think about Shingrix?
Emma Walmsley
executiveYes. So -- well, first of all, I think with Omicron, I mean, there's still an enormous amount that's, sort of, unknown about the pace of this. But we know the infection rate is exceptionally high. We know that proportionately, there's less post-hospitalization and death, although because the infection rate is so incredibly high, the actual volumes that are hitting hospitals is pretty high. Again, we also are all living -- I mean, I'm in the U.S. today, anywhere in London will see as well. The issue here is less a lockdown issue, it's more businesses stopping through the whole infrastructure questions of people not being able to work as they work through, in many cases, a milder infraction. So, I think, whilst there's still a lot to learn, the very near term is going to stay pretty disrupted. Big picture on Shingrix, we are not remotely worried, and we are extremely confident, still, that -- and we'll talk about this more when we have a bit more data on Omicron as well when we come to results and outlooks for 2022. But the reality is, we are sure that 2022 will be a strong growth year for Shingrix. This is an exceptional vaccine that -- and we're very confident in the fact that we're going to be doubling this business over that 5-year horizon as we talked about in June. In terms of the very short term, it's -- you're not having people locked up and sort of -- or in lockdown and therefore, afraid to go out. But obviously, people are prioritizing COVID boosters at the moment, so that needs to be worked through. But we shared our view of where we were at the end of Q3 and the outlook for Q4 on that, but our confidence in '22 growth is very high.
Keyur Parekh
analystAnd then, kind of, longer term, you've been asked a lot of questions about the perceived prep from mRNA, kind of, to the longer-term outlook for your vaccines business. We've recently seen, kind of, data for mRNA based vaccine kind of beyond COVID. Does that data set make you feel more comfortable about your longer-term outlook, less comfortable, just your read on where you see mRNA as a potential threat to your existing vaccines business, Emma?
Emma Walmsley
executiveYes. Well, I mean, first of all, we think about -- we wake up in the morning and think about the opportunities for growth and our ambition and accountability to make sure we compete, effectively, across the broadest possible portfolio of tech platforms. So, that's how we see mRNA. I know we weren't out first with a COVID vaccine in mRNA, but we do have a very broad and deep partnership with an mRNA platform with the option of moving into, I think, 5 or 6 assets. Overall, we've got 2 that we expect to be in the clinic by the middle of '22, both for, potentially, COVID and for flu. When you look at our existing portfolio, we were absolutely committed to vaccine and very confident for vaccines being a key driver of growth for us, whether that be Shingrix and obviously, some others who may come in and compete there with different technologies. But let's be clear, we have a 97% efficacy rate. We have an 8-year duration of efficacy for those that have already been vaccinated. And that's a 90% for the elderly as well. We have this adjuvant that has proven that sustained efficacy. We have unrestricted supply. So, the question is just digesting COVID. And by the way, it's not a seasonal vaccine either. So, that's another thing to be thoughtful for to your prior question on the impact of Omicron and how that works with boosters and the rest and why we're confident in being able to deliver growth. I think, the one area where we've seen stuff -- data come through, but it's still early days, of course. It's been in flu and there -- we've seen what we've seen so far, we know that there is an opportunity to improve efficacy, overall, in flu that hasn't been seen yet. We all agree there's a hypothesis of combinations, particularly in respiratory vaccines, but in others and indeed at GSK, we're working on those. We've already got a combo we're working on RSV and pertussis for maternal that we're looking at others, as you would imagine. So, I think we see this as an opportunity. The world has learned how to speed up. We have a new Head of Vaccines R&D, with a very deep level of expertise and experience on mRNA, and he's super excited to make sure that's included as part of our portfolio of technologies that's going to allow us to compete effectively and address all these needs. But he's not the only tech town. We're really excited to see also going to be in the RSV space in coming months for many of us, and there are lots of opportunities for growth. But in mRNA, we see the opportunity more than a threat.
Keyur Parekh
analystSo talking of RSV, how do you kind of -- how should we handicap your chances of success there? And how do you see, kind of, the competitive feed?
Emma Walmsley
executiveWell, don't handicap anything, thank you. It's -- I think it's exceptionally exciting in a space that I think, people have been working on a vaccine for obviously 50 years. Now, you've got all of this. I mean it wasn't 3 years ago, adult vaccination was sort of a rarity and we were pioneering alongside a couple of others in a few areas. Now, you've got several players engaged in RSV. And I think we are really excited to see the results that are going to come through. We are uniquely placed with the AS01 adjuvant, which has been so successful in Shingrix. We were pleased to be able to pull forward the expectations of readouts for the first half of the year. This is potentially an enormous market. And what is it, you've got more than 1 billion people over 60 in the world, and the hospitalization rates of RSV, not the infection rates, but the hospitalization rates are higher than for flu. So -- and I just think you're going to see a whole different market opportunity in adult vaccination after what the world has learned more recently. We know that in older adults, the AS01 adjuvant can work, but we've got to wait to see what the data shows. Our confidence is high from an efficacy, both on A and B strains. I think, there'll be interesting questions around duration, which obviously you can't prove in advance, but over time. And this is a technology that does have -- has had proven benefits on that. But then, of course, even in a world where there is more than one player, the end of the question becomes your commercial ability to compete. And I think we've demonstrated that at quite a few levels. So, very excited to see what comes through. Confident in the safety track record as well of this technology. So, watch the space. Don't handicap any of them.
Keyur Parekh
analystMoving on beyond vaccines. Kind of, you find us in a unique position with daprodustat, kind of, from being potentially being third to market and are potentially, kind of, being first to market. Kind of, [ while do more ], I said about daprodustat compared to some of the outcomes or, kind of, forecast you made on the June Investor Day, shouldn't you be kind of a bit more excited around it?
Emma Walmsley
executiveI'm very excited, Keyur, but one thing that's really important, and I think we've said this a few times, but I will keep saying it, is we're not going to be updating the individual outlooks on these medicines every time good news or bad news comes through. The reason we shared the outlook for the nonrisk-adjusted in those 11 key assets was simply because we knew that there was a question people wanted to understand around how you digest an end of decade pattern. And we just wanted to demonstrate -- and obviously, non-risk adjust -- we have risk-adjusted numbers and the assumption we had for our delivery of 30 -- more than GBP 33 billion at the end of the decade, but we wanted to give a sense of the scale of what we saw. Now clearly, some of the things won't work, not everything works and others are much better. And clearly, what we wrote in for daprodustat back then, was before we knew that others were failing, and it would be fair to say that our optimism continues to grow. But we're not going to be doing live updates on all of those numbers. But we are very excited. And having 5 Phase III come out, meeting their endpoints. Obviously, we still need to navigate discussions with the FDA and nobody should be -- no CEO should be commenting on what they think the outcome is going to be before they have the meeting. So -- but we obviously engage very deeply on what was required. But the demand here, potentially for both the dialysis and the non-dialysis market, the fact that you have the convenience of an oral option and the ability to manage hemoglobin in a very predictable manner. All of that, we think, bodes well for the process here. We're investing internally in terms of execution and are confident that we can do that. And obviously, preparing everything for regulatory submission is very much on track this half. So, more to follow. But definitely, that's one that's sort of gone up the list of opportunities and growth contributions.
Keyur Parekh
analystSo, better on HIV than June, better in April than June, kind of...
Emma Walmsley
executiveYes.
Keyur Parekh
analystExcellent. Anything you're feeling less confident about, Emma?
Emma Walmsley
executiveNot everything is going to work. And I'm not going to comment on that until we give you the data. It's inconceivable that all 11 come out as more confident than we predicted. But there will be -- yes, we've also made progress on our business development with quite a few things announced, obviously, more early stage. But as everybody knows, this is the way our industry works. You have those that succeed from more than people may have initially expected, there will be things that fails and then we add to it with BD and none of that, and our early stage stuff and none of that was included in our outlook. So, overall, our ability to improve R&D productivity with a broad team of R&D leadership and the talent that we're bringing in is just improving all of the time. So, I'm really feeling very good about the outlook of this business.
Keyur Parekh
analystYou touched on 2 things, which I want to, kind of, dwell a bit deeper into. One was R&D and the second one was kind of business development. Starting with R&D. I mean, you've got a lot of Phase II and Phase III readouts coming out over the next, kind of, 6 to 12 months. And as one thing's about, kind of, our perspective of what's, kind of, built in to your implied value of the biopharma business that could be significant upside to those. So, as, kind of, you think about the next 6 to 12 months from a data readout perspective, what are you really, kind of, looking forward to on that end?
Emma Walmsley
executiveWell, I think the way we think about it is not just data readouts, but all the sort of key moments of either submissions or approvals on these 11 assets and then things that we'll add in and it's next 6, 12, 18 months are going to be very important across several of them. I don't want to miss repeating the approval of cap PrEP, which came in December, which would have been one of the things we were expecting in early this year, is a big deal. So, that's very important. And likewise, the submission of dapro is a big landmark for a potentially major new medicine. In terms of Phase III readouts, we've already referred to RSV. That's going to be a key. Very excited, as both an adult vaccination leader and a respiratory leader to see where that goes. I would also -- I think in the first half as well, that -- correct me, we've got the HPV readout, which is a Phase II, but all of the hep B opportunity is potentially interesting. Let's see, but there are quite a few markets in the world where the hep B opportunity is significant and that could unlock growth for us. And we've also got the Phase III for gepo, which is this UTI opportunity, which is an incredibly common disease. Antibiotics are always difficult, but this is one of the first new antibiotics for a long time. Otilimab is a bit of a, kind of, always low profile opportunity, but in the sense that it's not often discussed, but obviously, the RA market is huge, and there, we have a Phase III coming through with a slightly more complex situation with some of the standard of care. And potentially, let's see, we've got a pain benefit that we saw in earlier study. So, let's see what happens with that one. We have the combos in Menveo, as well. And then, of course, over the next -- we've got a whole flu over the next 12, 18 months of BLENREP updates. And that's obviously stayed a very small medicine whilst it's in late lines, and we're navigating on REMS. If we can unlock earlier stages, and we've put in no numbers whatsoever for first line, but if we can get into third and particularly second line with some of these different routes that the team have been looking at, then that would be important.
Keyur Parekh
analystTalking about BLENREP, I mean, kind of, if you look back, kind of, a Zoline BLENREP confluence of events over the last 24 months have been, kind of, I guess, somewhat below what the Street expectations were. As you think about those 2 assets, do you feel like you need incremental data to unlock those commercially? Or is there things you can do without incremental data?
Emma Walmsley
executiveWell, let's start with -- the world sees what's happened to the Onc market very tragically. I don't like calling it a market. What's happened there has just been awful with diagnosis rates down so dramatically, with surgery rates down so significantly. And then obviously, if you're in a maintenance business, that's tough. I'm really proud of -- and I've just been visiting with the teams here, of the competitiveness of commercial execution in ovarian cancer. We're very pleased to have, what we believe, is not all parts of the same and to be now getting 1 in 2 of all of the, sort of, new patients on maintenance and to see the kind of market share gains that we've consistently driven. The challenge is still the market is below where we'd like it to be, but I'm confident that women, hopefully, as the health care systems digest what's immediately in front of them, and it's unfortunate that seems to be likely to be delayed a bit further, but our commercial execution there can continue to deliver. Obviously, and this is not pending imminently, but in a few years' time, being able to move Zejula into other indications, which we have studies ongoing for both lung and breast will matter. But in the meantime, there's plenty to be done, operationally, and not least when the market comes back to normal. But good growth overall, nonetheless. And we do see oncology. It's amazing when you think that we had no drugs in oncology 3 or 4 years ago and almost nothing in the clinic. And now, we have 3 approved and a whole bunch in the clinic and some exciting early-stage combos for on the next gen immuno-oncology coming through with all the work that we've had going on, on the 226 pathway. But on BLENREP, obviously, very small at this stage in fourth line. And navigating REMS, I think, well, and we have very positive feedback on how that's been working. But that will only get to any scale when it goes into earlier lines. And therefore, we've got all these studies looking at dose reduction, which is encouraging, so far. Changing frequency of dosing, modification, when the corneal changes are observed. Combinations, lots of combinations with existing standard of care and then some normal combinations as well as you know, GSI. So, let's see. I think for that to move in any meaningful way for sure, we definitely need to be able to get into earlier lines. So, more on that, as we said, in the next 12 to 18 months.
Keyur Parekh
analystAnd the other part of this, obviously, business development. And I think, as you were kind of talking at the start, you spoke about, kind of, cleaning up the balance sheet. I think, you spoke about it more eloquently than I just rephrased that part. Can you talk to us about, kind of, your focus or, kind of, what your capacity is, what your firepower is, kind of, from an M&A perspective? How do you see the Board, kind of, the need to do it, but also your one thing you want to do it?
Emma Walmsley
executiveWell, again, I think, right when I started and with R&D leadership, we said our #1 priority was strengthening the pipeline, and we were going to do that organically and inorganically. And we have significantly increased the amount of BD that we do as a company. I mean, more than threefold in the last few years. We've remained very focused on early-stage bolt-ons on the -- when appropriate. But also, platform deals and technology partnerships, which we know, people will want to see translate into assets and pipeline growth, but we're very confident as we look through the decade back to your very opening question, that you're going to see real productivity of our targets. And actually, we've got more than we know what to do with, frankly, coming through there. And then, you have new tech platforms like the mRNA deal and others, too. In terms of need, I'm going to repeat. The outlooks that we have given for the new GSK, more than 5, more than 10, at least 33, excludes business development. We don't have a massive patent clip until the end of the decade. So, we are not a company, and we all have momentum, and we are making progress on all of the key areas of change that we focused on. So, this is not some urgent requirement. However, anybody that says to you, they don't want more of a pipeline, I think, more is always better and more growth is always better. So, we continue to pursue. And one of the main reasons that's driving the separation of consumer: number one, shareholder value; number 2 -- and that's why we look very carefully what are all the different mechanisms? And we still hold shareholder value as our primary bar for the choices there. Number 2 is strengthening the balance sheet of GSK, because for a variety of reasons, including needing to deal with the put option on the Novartis deal and frankly, set for appropriate distributions for the new company, we want to get the balance sheet allowing us more capacity. And that's why being able to say, we will transfer up to GBP 8 billion across to the Consumer business, making a deliberate choice to retain purely as a financial asset that will demonetize in a pragmatic manner, in a timely manner, 20% of our holding through that separation. But also, the reset dividend and the improved and ever-improving ability for us to deliver free cash flow. So -- and not doing any further restructuring. So, all of those things now, I think, set us up for the capacity that is -- that will give us the freedom to do the kind of deals that we want to do. And in terms of the criteria for that, we've said where our 4 key areas of focus are, but we remain very open to opportunistic opportunities as long as they are in line with our R&D strategy, which is immunology, genetics or new tech platforms, and a lot of discipline in terms of returns.
Keyur Parekh
analystMy, we're kind of coming up to time. But kind of, given how much time you spend on the Consumer Health business, it kind of seems like that landscape is going to evolve quite fascinatingly. Obviously, you're going to have your Consumer Health business, you're going to have, kind of, the J&J business, kind of, separating out or doing something. And there are a couple of other, kind of, reasonable-sized consumer health assets involved embedded within pharma companies. Just -- How do you see that landscape kind of developing over the next 5 to 10 years and kind of -- I guess you are, but if you were running GSK Consumer, what would your dream scenario be there?
Emma Walmsley
executiveWell, first of all, it's not going to be GSK Consumer. You will see all that comes there. And I am just -- I'm so excited about the value of that is being created with that portfolio, and I'm very confident of its competitive top line delivery as well as, as I said, ongoing sustainable margin progress. And I just can't wait for Brian and his team to be able to share all of that with you. And frankly, I think this is the question that you should definitely ask him at the CMD or at least your colleague should. I think, there can be no debate that the Consumer Healthcare market is a very exciting place to be because the world is alive to the benefits of self-care more and more and more, that it is a business with purpose and an easy conversion to ESG delivery from that. It's very easy to recruit top talent from both consumer goods and health care expertise into that space. Governments with aging populations, the fundamental dynamics of the world market of aging populations, governments that need more self-care going on and preventative care going on, the surge in digital opportunities, even down to the simple things of -- I mean, consumer diagnostics. Who would have thought we'd all be as good as we are at home kits on diagnosis as we've become over the last 2 years. And I think, it's still of a very fragmented industry, which is why it was great to be able to do the 2 biggest deals in the sector in the last few years and unlock the value of the synergies there. I suspect there will be more opportunities. And one of the reasons I wanted to set that business free is you can't have it sat inside another company with GBP 10 billion of sales and not be the priority of capital allocation. So, it will have its freedom to operate at the speed with the -- it's still a regulated environment, so you need expert know-how there and you've seen people stumble without that. So, this is based on science and a very serious regulatory capability, including for market opportunities and switch, et cetera. But at the heart is knowing consumers and bringing that human understanding, too. So, this business is incredibly well placed. It's nice to be leading the way. I'm sure that others will follow, and I think it will be a very exciting place to be.
Keyur Parekh
analystEmma, any kind of final thoughts for you to leave us with kind of, before we say goodbye to you?
Emma Walmsley
executiveWell, just to say, this is a very exciting landmark year for GSK, and we want to be as engaged as we possibly can with all of our investor community across the management team and also, with new IR leadership as well. So, we look forward to keeping you very updated. And most of all, watch this space for the announcement for the CMD for Consumer and near term, and we look forward to seeing you all then as well as at our year-end results for the outlook '22.
Keyur Parekh
analystExcellent. Emma, thank you very much for your time. I really appreciate it. Hope you enjoy the rest of the day and safe travels back to the mother ship.
Emma Walmsley
executiveWonderful to see you.
Keyur Parekh
analystThanks all for joining us. And we hope you have a good rest of the day. Thanks, Emma, again.
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