GSK plc (GSK) Earnings Call Transcript & Summary

Good morning, and good afternoon. I'm James Gordon, JPMorgan European pharma and biotech analyst. And today, at the JPMorgan Healthcare Conference, it's my pleasure to introduce the GSK session with GSK Chief Scientific Officer and President of R&D, Hal Barron. Today, we'll have a 20-minute presentation from Hal, and then we're going to take 20 minutes of questions. And then, we'll also be joined by other members of GSK executive team, CFO, Iain Mackay; and President of Global Pharmaceuticals, Luke Miels. And you can immediately start registering your questions. The way you do this is with the Q&A function that's associated with this presentation on the conference website. And then I'll be reading out your questions from there. So with that said, I'd like to welcome Hal to the conference, and Hal, over to you for the presentation.

Good morning. Thank you, James, and thank you all for joining us here today. First, let me refer you to our cautionary statement on Slide 2 of my presentation and then move to Slide 3. 2 years ago, we laid out the pathway to the creation of 2 new companies: a biopharma company with a strong presence in specialty medicine and vaccines focused on the science of the immune system and genetics; and a world-leading consumer health care company. We've taken great steps towards realizing this vision. And as a consequence, we're moving more confidently than ever towards the creation of these 2 companies that will deliver significant new options for sustainable growth and attractive returns for shareholders. On Slide 4, you can see some of the significant progress we made in 2020 towards our strategic objectives despite the challenges of the pandemic. From an R&D perspective, we continued to strengthen and advance our pipeline. We received 9 major approvals, including the approval of 4 new molecular entities. We delivered positive data on multiple high-value programs, leading to the initiation of 9 pivotal studies. Our focus on genetics has resulted in more than 70% of the targets in research now being genetically validated, and importantly, business development continued to augment the pipeline with more than 20 business development deals signed. In terms of performance, our fundamentals continued to improve despite short-term disruption, most notably on vaccines. In particular, we achieved strong commercial execution in specialty products, and we made substantial progress on our consumer integration and company separation programs. Lastly, we continued to build trust in the company, exemplified by our efforts to advance a unique portfolio of COVID solutions and our adoption of industry-leading environmental targets. Against this backdrop of significant progress, I want to focus the remainder of my comments today on our continued efforts to drive innovation and build a sustainable high-value pipeline that will provide significant benefit to patients. Turning to Slide 5. In July of 2018, I introduced our new R&D approach focused on science, technology and culture. Today, I'll not have time to talk about the significant progress we've made on improving our culture, and I'll only briefly be able to touch on some of the advances we have made related to our focus on technology such as functional genomics. Instead, I'll spend majority of my time focusing on the science, particularly on our late-stage pipeline assets. Across our pipeline, we have seen the benefits of our commitment to immunology and human genetics. In oncology, our focus on immunology has resulted in numerous novel immuno-oncology medicines and several innovative cell therapies. Our focus on human genetics and functional genomics has led to the formation of a synthetic lethality research unit and through business development, a growing portfolio of programs and several important collaborations. In infectious disease, this led to a significant number of opportunities across both vaccines and pharmaceuticals, including solutions for COVID-19 pandemic. We're also now seeing real value coming from our commitment to life cycle innovation due in part to closer collaborations between the commercial and R&D organizations. A particularly good example of this is the number of new launches with Nucala, our IL-5 inhibitor; and most recently, with the advancement of our long-acting IL-5 program, which we're planning to move into pivotal studies this year. I will spend today speaking about each of these areas and highlight assets which we believe have the potential to be transformative vaccines and medicines in our fight to treat and prevent disease. Moving to Slide 6. This slide highlights the 60 vaccines and medicines in our pipeline which are focused predominantly on infectious disease, oncology and immune-mediated diseases. 25 of these assets are in Phase I, 14 in Phase II and 21 in potentially pivotal studies with the vast majority of these assets likely being first or best in class. As you can see on Slide 7, based on our current projections, by 2026, we will likely gain approval for numerous new vaccines and medicines as well as new indications for existing assets. In addition and importantly, we believe we have more than 10 vaccines and medicines in the late-stage portfolio that could change medical practice and have sales potential in excess of $1 billion and several [ carve-outs ] such as our RSV vaccine in older adults could have multibillion-dollar potential. Given the time constraints, I cannot discuss all these carve-outs today, but we will be holding an R&D event in June where you will hear a lot more about our exciting portfolio of transformational vaccines and medicines. Turning to Slide 8. We have made significant progress in oncology. And this slide highlights our current development portfolio with 15 assets broken down by the research area they came from. We decided in 2018 to focus on human genetics, functional genomics and advanced technologies such as machine learning in order to become leaders in the field of synthetic lethality. This led us to acquire TESARO, bringing Zejula, the potentially best-in-class PARP inhibitor based on the PRIMA study, into our portfolio. Subsequently, we established a research unit based in Boston focused on synthetic lethality and announced a collaboration with IDEAYA to bring additional synthetic lethal targets into our portfolio. And very recently, we established our collaboration with one of the world's leading functional genomic centers, the Broad, which allows us to leverage this great institution's focus on genetics and drug discovery. Another commitment we made in 2018 was that our primary focus would be on immunology. And as we have noted and as widely appreciated, one of the more promising areas to develop medicines in the immunology today is within oncology. We've made significant progress in this area and now have 9 promising I-O agents and 3 cell therapies in our portfolio, giving us a very exciting immunology-focused oncology portfolio and one that will enable numerous combination studies, several of which I'll highlight today. Moving to Slide 9. BLENREP, the first approved BCMA-targeted therapeutic, is our most advanced immune-modulating asset. In addition to blocking BCMA and delivering a potent drug toxin, it has enhanced ADCC activity and induces an immunogenic cell death, both of which we believe are important for its impressive efficacy. Treatment with BLENREP resulted in a 32% overall response rate in heavily pretreated multiple myeloma patients, leading to a 12-0 positive FDA ODAC vote, U.S. and European approvals and encouraging uptake since launch. As many of you are aware, keratopathy is a side effect that some patients experience when receiving BLENREP. We take patient safety very seriously and are focused on helping physicians and patients understand and manage the corneal events as well as finding ways of reducing the risk, including through alternative doses, schedules and potentially, combination therapies. One of the approaches I'm particularly excited about is the novel combination of BLENREP with SpringWorks' gamma secretase inhibitor, which inhibits the cleavage of BCMA from the cell membrane. This could result in a higher expression of BCMA on plasma cells, which could enable a lower dose to be used and still preserve the impressive efficacy scene. We should have some preliminary data on this combination from the ongoing DREAMM-5 study by the end of this year. There is significant potential for BLENREP in earlier lines of therapy, and this was highlighted at ASH last month when the Canadian Myeloma Research Group reported compelling data from the Phase I/II ALGONQUIN study in the second-line study setting. The key message from this study was that deep responses are being seen with BLENREP when given in combination with Pom/Dex. Across the 2 different dose regimens, the combined overall response rate was 88%, and there was a 100% response rate in patients who actually were refractory to an IMiD, PI and daratumumab. In terms of safety, the overall incidence of corneal events was reduced with the lower dose regimen, supporting our belief that the GSI combination study could be very valuable to patients if we can reduce the dose while preserving efficacy. These encouraging results also reinforce our confidence in our 2 pivotal second-line studies, so-called DREAMM-7 and 8, which we expect to report out in the '22, '23 time frame. Finally, these data and actually data that we generate in the next 12 months in the DREAMM-9 study, the ongoing dose exploration study in newly diagnosed patients, will help us understand what the optimal dose and schedule of BLENREP is in the frontline setting, enabling us to unlock the full potential of this transformational medicine. On Slide 10, I highlight another potential medicine in our I-O portfolio, our unique first-in-class ICOS agonist antibody called feladilimab. ICOS is an agonist receptor on T-cells that stimulates T-cell expansion. Feladilimab is an IgG4 antibody designed to stimulate and grow cytotoxic T-cells without depleting them as seen with other antibodies. We are developing our antibody in combination with pembro for patients with first-line relapsed metastatic head and neck squamous cell cancer in 2 Phase II/III studies, INDUCE-3 and INDUCE-4. INDUCE-3 is enrolling ahead of schedule despite COVID, and we expect to have data from the first interim analysis in the first half of this year, [ which we assume will ] actually support progression to the pivotal studies. ENTRÉE lung is our randomized Phase II study looking at overall survival in non-small cell lung cancer patients, which should read out in the first half of this year, and we intend to share that new data from INDUCE-1 in various different tumor types by the year-end as well. So as you can see, there are a number of upcoming data readouts, which will clarify the potential of this potentially transformative medicine as well. On Slide 11, I want to highlight one other area in immuno-oncology that while early is very exciting to us. That is modulating the CD226 axis. CD226 is a co-stimulatory receptor on T-cells and NK cells that we believe plays an important role in cancer immune surveillance. We have in the clinic the first agonist CD96 antibody being developed with 23andMe; and through a recent business development deal with Surface Oncology, a potential best-in-class anti-PVRIG, which should enter the clinic in 2022. The potential to combine these 2 medicines or, frankly, to combine them with a PD-1 inhibitor or even with a TIGIT antibody, where the preclinical data actually shows a nice synergy, is very exciting and is another approach we're pursuing to become a leader in immuno-oncology. On Slide 12, I want to switch from oncology to infectious disease, where we have a world-class pipeline of 32 vaccines and medicines and a marketed portfolio of 21 vaccines and medicines, which had revenues in excess of $17 billion in 2019. In light of COVID and the advancements made, it's also important to highlight that we also have some exciting early-stage vaccines that leverage our extensive portfolio of platform technologies, including mRNA, both nonreplicating and what we call self-amplifying; as well as viral vector and adjuvants, with several of these expected to move into the clinic over the next 18 months. Of the 32 vaccines and medicines in development, we have -- that have the potential to transform patient's life, I'd like to highlight 5. First, our antisense compound, so-called GSK'836, which may provide the first functional cure for people with chronic hep B.; second, gepotidacin, which could be an important new treatment option to combat antimicrobial resistance and potentially, the first new antibiotic in 20 years to treat patients with uncomplicated urinary tract infections and urogenital gonorrhea. I will now spend a few minutes on the other 3 assets I want to highlight. Turning to Slide 13. One of the highlights of 2020 was the exciting Phase II data we shared on our RSV vaccine for older adults and mothers at the ID Week in October. Both vaccines are based on a recombinant subunit prefusion RSV antigen, which is believed to trigger the required immune response. For older adults, we combined this with our proven AS01 adjuvant to enhance the immune response. This Phase II data showed our vaccine induced a near tenfold increase of protective antibodies. Importantly, T-cells were boosted to a similar range to that observed in the younger adults given non-adjuvant vaccine, and importantly, the vaccine was well tolerated. Clearly, this is highly encouraging data, and we will be moving into Phase III this quarter. We anticipate receiving initial results in the second half of 2022. Vaccinating the elderly against RSV represents a major unmet medical need, with RSV infections resulting in over 170,000 hospitalizations and 14,000 deaths a year in people over 65 in the U.S. alone. Not only could this vaccine have profound clinical benefit, but from a commercial perspective, when you take into account that this population also -- often receives vaccines against flu and pneumococcus, you can see this represents a very sizable opportunity. Staying with infectious disease and moving to HIV on Slide 14. We are progressing 2 very important indications for our long-acting injectable cabotegravir. Cabenuva, which combines our integrase inhibitor cabotegravir with rilpivirine, is the first and only once-monthly treatment regimen to show a non-inferior efficacy and comparable safety to a daily oral 3-drug regimen. Why is this important? Well, for many people infected with HIV, the stigma and daily reminder of their HIV status is a serious issue and one which can affect treatment compliance. Our market research suggests that up to 2/3 of people with HIV express strong interest in a long-acting therapy, and in our pivotal studies, nearly all patients showed a preference for Cabenuva. European approval was granted last month, and we expect FDA approval this quarter. We're also -- we also reported very compelling data last year for long-acting cabotegravir in the prophylaxis setting. Compared with oral daily therapy, long-acting cabotegravir will reduce the incidence of HIV by 2/3 [ in men and transgender women ] and nearly 90% [ in women ]. While the clinical implications of these data are profound, there is also a substantial commercial value here. Specifically, there are over 200,000 U.S. patients on PrEP, and it has been estimated by the CDC that there is as many as 1.2 million people who could benefit from prophylactic treatment. We expect U.S. submission in the middle of this year, and we believe both Cabenuva and Cab PrEP will provide significant benefit to patients as well as have blockbuster potential, which will help our HIV business deliver attractive revenue growth in the coming years. Now turning to Slide 15. We also have been active in the search for solutions to the COVID global pandemic. We have an ongoing study with our anti-GM-CSF antibody otilimab as a treatment for patients with severe pulmonary COVID-related disease, which we expect data from soon. We also have collaborations underway with Medicago, Clover and Sanofi in which our proven vaccine adjuvant is being used to support the development of vaccines for COVID. We expect pivotal data from each of our vaccine collaborations by the end of this year. I want to focus today on VIR-7831, which we, along with our partners at Vir, believe has the potential to be the best-in-class antibody for COVID. This is due to 3 unique characteristics. First, this is a very potent neutralizing antibody and by binding to a unique and highly conserved epitope is expected to confer a high barrier to resistance. And this might become extremely important given some of the recent reports of mutant strains, as I'm sure you're all aware. Second, this antibody was designed to have increased effector potency, potentially allowing for greater efficacy, and this is in part why the NIH chose this molecule for the ACTIV-3 in-hospital study. And finally, and importantly, VIR-7831 has been engineered to have an extended half-life with the so-called LS mutation, which should enable us to observe efficacy at a lower dose, which could enable IM dosing. Currently, VIR-7831 is in 2 Phase III studies, COMET-ICE in outpatients at high risk of hospitalization and ACTIV-3 for the treatment of hospitalized patients. The latter is a setting where other monoclonal antibodies have failed. However, as noted, we believe VIR-7831's impact on effector function may actually confer unique activity. I know George Scangos, the CEO of Vir, will be sharing more on this program during his presentation, which I strongly encourage you to attend. Turning to Slide 16. As I mentioned earlier, the R&D organization is working very effectively with the commercial organization to ensure we have robust life cycle innovation plans. Benlysta's recent approval for lupus nephritis is a great example of this as is the expansion of Zejula into non-small cell lung cancer with the start of the [ ZO1 ] pivotal study at the end of last year. The third example that I'd like to spend some time on is our IL-5 program. Nucala, which we have developed for numerous indications, is the first biologic now approved for severe eosinophilic asthma, eosinophilic granulomatosis with polyangiitis and hypereosinophilic syndrome. Nucala is also under regulatory review for treating patients with nasal polyps and in a Phase III development program for patients with COPD. In addition, we've developed a long-acting IL-5, so-called GSK'294, which has been engineered for high affinity and long-lasting expression of IL-5, allowing it to be dosed as a convenient subcutaneous injection once every 6 months. We are moving this medicine into pivotal studies this quarter based on positive in-house data. And with its validated mechanism of action, we believe it has a high probability of success and significant commercial value. We expect results from our Phase III program around 2024. As an aside, this asset will have progressed from first-in-human study start to Phase III in just 3.5 years, a great example of the cultural shift we're driving at GSK and the focus within the organization on delivering at pace. Now turning to Slide 17. Business development has been critical to augmenting our pipeline, and we have accelerated the pace of activity here, and we'll continue to do so. I've mentioned a number of these deals and collaborations, including Broad, IDEAYA, TESARO, 23andMe, Surface Oncology, Vir, during my presentation already. I quickly want to highlight our recent collaboration with Steve Jackson and Adrestia, addressing a new area of science called synthetic viability, complementing our focus on synthetic lethality. All of the deals on this slide should deliver significant value to GSK, either by adding strategically targeted assets to our pipeline or providing us access to world-leading technologies and outstanding scientists, and business development has and will continue to have a significant role in optimizing our portfolio. Next slide. We had a lot of important news flow in 2020 with multiple approvals, positive data readouts and pivotal study starts. We, as you can see on the slide, expect to build on these with a number of notable events in 2021 as shown. So last slide. In summary, let me say I'm extremely pleased with the progress we've made over the last few years. I'm confident that the approach we're taking will deliver transformational vaccines and medicines for patients. That said, we'll continue working to build an even stronger, more productive, more innovative R&D pipeline, leveraging the strong foundation we have in immunology, human genetics and advanced technologies that we've established. I highlighted today a small number of the many assets in our pipeline that could be both transformational patients -- for patients and have significant commercial opportunity. Successful development of these assets underpins our confidence in the accelerated performance we expect to see as we move through 2021 and beyond. I look forward to providing a more detailed R&D update in June. And with that, let me hand it back to you, James, to open it up for Q&A.

Great. Thanks very much for the presentation. So this starts the Q&A portion. And as a reminder, in addition to Hal, we've got CFO of GSK, Iain Mackay; and President of Global Pharmaceuticals, Luke Miels, with us as well. And we've got about 20 minutes. And you can register your questions on the website, and I've got a few questions that have come through already. So I will kick some of them off -- kick some of those off. First one was -- so the question is -- so maybe this is to Hal. So you mentioned you have done significant work improving culture. Can you elaborate on any metrics or processes you believe have improved? And what further improvements might we expect? And how has this helped to decision-making in R&D and science?

Thanks, James. It's a great question. And really to do a service in terms of answering it thoughtfully would take quite a long time. So let me just mention a couple of different things we're doing that I'm proud of. We have 5 pillars of our culture that we constantly focus on. Let me highlight one of them, which is called smart risk taking. One of the things that we're trying to incentivize is for teams and people who are making decisions to take smart risks, to not hide behind a decision that's very likely to be correct but very, very low risk and adds very little value. In other words, deciding that something is likely to fail is not very helpful. We all know that these things are high risk. What we like to incentivize is people taking smart risks, taking a risk that may mean that the asset won't work but that by investing in it and seeing it to its completion, we can actually discover new medicines. We have what's called Transformational Medicine Awards that we provide to individuals in the R&D organization for outstanding work, and many of them are for quite significant successes that have come throughout the year. But we also highlight a few teams that have made courageous decisions to cancel projects because the data suggests that there shouldn't be a move forward, that it's negative and moving that -- those resources to more promising molecules would be a smart risk to take or a smart decision to take. And lastly, let me just comment that we're also constantly evaluating through governance models that -- what we call the portfolio investment committee that Luke and I chair, that we're constantly looking at very rigorous analytics so that we can optimize our decision-making and really decide which molecules we should be trying to do parallel development work in so to maximize the value, which ones are very risky and we might want to take a more gated risk approach. And somewhere, it's very time-sensitive, and we provide extra resources for the teams to go very quickly. And you could see an example of the latter with Belamaf, which just a few years ago, was in Phase I and now is already approved. We have some other programs that we're pushing very quickly, as I mentioned, with the IL-5 long-acting. So both through governance, incentivizing through smart risk taking and things like that, I think, we're making a big advance in the culture. But I don't want to take too many more minutes in -- with that question. But it is very important at GSK, and I think we're making nice progress.

Okay. Another question here is what was the dimension of TGF-ß trap? If this works, could this actually be the biggest of all the pipeline products you mentioned?

Well, it's a great question, and we're very excited about bintrafusp. Its potential to be better than pembro in a lung study is, of course, enormously game changing, if that was to work. Frankly, we have a limited number of minutes, and I wanted to focus on a few of the assets I thought maybe the audience was less familiar with. But you're right that, that asset could have very, very large implications for patients and commercially, if it was to work.

A question here is Moderna are starting HIV and seasonal flu programs using mRNA. So what are your thoughts on this as a competitive threat to some of the areas that GSK are in?

I think we've seen a lot of new information from COVID on the value of some advanced technologies in the vaccine area, and GSK is very focused on ensuring that we are leaders in these advanced technologies. We, as I mentioned, have a number of programs looking at both mRNA and some of them with our collaborator, CureVac; as well as a very exciting mRNA platform with -- where there's self-amplification, which we think could be very successful. And as I mentioned, a number of those programs will be in the clinic soon. So we're very excited about the potential transformation that's occurring in vaccines and intend very much to be the leader in all of that.

Okay. There's one here which -- the question is you recently renegotiated your agreement with AnaptysBio on your PD-1. You gave up a lot of the economics. How should we interpret that relative to how large the market could be for dostarlimab? And can you talk about your overall strategy within the I-O space and where you think it could fit in, in the depth of your pipeline in I-O?

And maybe I could turn it over to Iain or Luke, if you want to comment both on the deal and then the potential for dostarlimab commercially. And then I'll talk about the I-O strategy overall, big picture. Iain, I don't know if you have comments on the first part of the question.

Yes. I think probably that's best taken by Luke, Hal. I think clearly, from our perspective, the importance of this asset was what informed the renegotiation with AnaptysBio. And I think that's probably the best way to describe it. But in terms of commercial opportunity and then going beyond that, how it informs the development of clinical studies in this space, I think probably, Luke and yourself, Hal, should take that on.

Okay. Luke, could you maybe comment on that?

Sure, Hal. Yes. I mean, I think the value is directly connected to combinations, for example, with Zejula or other assets in the pipeline. I think we need to recognize that there are a lot of PD-1s, PD-L1s out there, but it's the combination approach that gives us opportunities. It also lowers clinical costs. Of course, we can -- Hal's team can conduct experiments with dostarlimab, which is a competitive asset and absolutely at lower cost and without having to disclose those activities to a partner, so combinations.

Yes. And let me touch on -- thank you, Luke. Let me touch on the kind of high-level I-O strategy, if you will. One of the things that is important is our focus on oncology is really to be very targeted in specific areas. And the 2 that we chose to really go deep on is the use of immunology in cancer, as I mentioned, and that really takes 2 forms: immuno-oncology targets, the traditional way of defining them; as well as cell therapy. Also, very importantly is this idea of using human genetics, functional genomics and machine learning to identify new targets in the synthetic lethality space like Zejula and the numerous deals -- the numerous targets we got from IDEAYA. But specifically with I-O, I think our belief is that there will be a series of medicines that evolve to be complementing or even being superior to the PD-1 inhibitors over time. Certainly, there's been some setbacks in some of the medicines that we had hoped would do that, but we've strongly believed that there will be some. The areas that we're most excited about, as you can see, is modulating BCMA with this unique immune modulator. We are very excited about ICOS because agonizing the T-cells to make them more cytotoxic could be very effective, and there's some biomarker data that would support the potential for synergy. We're very excited, as I mentioned, about bintrafusp. We have a STING agonist. The whole CD226 axis, whether that's TIGIT, CD96, PVRIG, a number of targets in that pathway, we think are very important in terms of immune surveillance. And so the key for us is finding novel targets that could be first or best in class, where we really understand the biology and with CD96, actually, the genetics as well and designing trials that will give us confidence that they are likely to be synergistic with a PD-1 or additive on top in failures, things like that. So the combinations play a very key role in our portfolio. So the 15 assets in oncology, which I said 12 are in the immune space, 9 of which are I-O agents, really represent a real opportunity for combinations that will be very, very exciting should they work. So I can go on a lot more on that, but stay tuned. I think you're going to see a lot of really interesting combination data. And as Luke said, the PD-1, dostarlimab actually gives us even more flexibility for these combinations.

Maybe just a follow-up on that. So for dostarlimab, we've got the MOONSTONE's data coming up this year. So this, we're looking at PD-1 with a PARP. How much data do we now have? Let's say going forward with the patients that have actually got DDR mutations, if there is actually a synergy and you can -- if you stick a PD-1 with a PARP that makes it work in everyone, do you see MOONSTONE as quite high risk? Or do you think it's well validated already? And maybe -- so maybe also just on lung cancer, I know you're looking at doing this combo as well.

Well, I would say that it's -- nothing is a slam dunk in immuno-oncology, that's for sure. And I think the biology behind why typically some tumors like ovarian cancer have been cold in the sense that they have not been responsive to PD-1 inhibition is unclear. You -- it also is very challenging because sometimes the tumor's immunogenicity profile and ability to be attacked effectively by T-cells is multifactorial and maybe even stage dependent. So it takes -- this field is not for the faint of heart. And yet, at the same time, the potential benefit to patients is enormous when successful. So we believe that a number of combinations of a PD-1 or immune checkpoint blockade with Zejula could be very effective, whether it's in the maintenance setting or in the treatment setting, whether it's in the frontline or the latter lines. And which subgroups of patients would benefit the most needs to be determined. There is encouraging data on the use of PD-1 inhibition in the MSI-high cancers, where we see mismatch repair defects and we see activity. And whether we can augment Zejula's activity with a PD-1 or maybe an ATR inhibitor or Rad50, a number of different synergistic combinations that were -- that have been proposed in the literature, we do think there's an opportunity in ovarian cancer for women to benefit from combinations, and our PD-1, Zejula combination is one of several. But we're optimistic that we can find places where PARP, PD-1 is synergistic and maybe a little bit more complicated than it might seem on first glance, but we're committed to doing this for patients.

And if MOONSTONE does work, does that give a lot of validation to the hypothesis that the same sorts of approach could work in lung? Or do we need to be quite careful reading between them?

Well, I think the positive predictive value is probably higher than the negative. There's lots of ways these things can fail. If they do end up working, I think it's instructive. I think I would look at MOONSTONE as well as the first trial and take the aggregate data of all the different PD-1 inhibitors in the various settings and the various lines and interpret that more globally than resting on any one trial. But that said, I do think that there will be emerging data over the next few years to suggest that PD-1 inhibition plus a PARP -- a lot of people forget that not only is their synthetic lethality with PARP inhibitors, but by -- in the cells that don't die. By having to use non-homologous end joining as their means of protecting the cell's viability, they will, by definition, start creating basically mutant proteins, nonhuman proteins, because of the non-homologous end joining, and that might be something that induces neoantigens. And if that's true, you -- it's potential that you could induce a so-called cold tumor into a hot tumor through that mechanism. Now we know that just simply making a tumor express neoantigens is not enough sometimes. You need to both block the PD-1 axis to make that effective, and sometimes, as we know in lung cancer, not everybody is responding to PD-1 inhibition. In fact, it's the minority. So might it need to be that you need a CD96 inhibitor, a TIGIT inhibitor or -- to complement the PD-1 or an ICOS agonist or a STING agonist, there's a lot of interesting data on STING and the interferon pathway as it relates to PARP inhibition. And so that's very, very complicated biology. But when you look at the transformation that's occurred in oncology through the benefits from antagonism in PD-1 and if, like us, you believe that there's likely to be a next version, if you will, of immuno-oncology beyond PD-1, we think this could be probably the most exciting area in medicine to date.

One more popped up here, which is saying can you elaborate on your vaccine program against Staph aureus?

Well, it's early. And when you say -- did you say differentiate -- could you say the question once more, James?

Can you elaborate on your program against Staph aureus?

It's early, and it's a very interesting and exciting opportunity to think about how vaccines can be used in areas that have traditionally been challenging for medicines. Why don't I take that question and defer that to June, where I think we're going to go into a lot more detail on not only that program but the whole vaccine's approach to some of these difficult-to-treat infections.

And actually, as a follow-up to June, can you talk about -- so what are we going to get at the event in June? Will there be lots of new clinical data? Will it be more about sort of plans for new studies that you're going to start? What would we learn?

Well, I think you'll get a better feeling for a more in-depth assessment of the various molecules that we had no time to talk about today and haven't had the time to talk about in the past. As I said, we have 60 vaccines and medicines in the pipeline, and we just didn't have enough time to talk about them all here or on the quarter calls. So you'll have a much more in-depth analysis of the science behind these molecules, why we're excited about them, the development plans. And hopefully, there'll be data emerging over the next 6 months that we'll be able to share as well.

Well, I haven't asked Luke or Iain much. So maybe a question in the last few minutes. I mean -- one will be actually, Hal, I think you mentioned some disruption to vaccines as a result of COVID. So maybe for Luke, in terms of -- what is the outlook for vaccines, say, in the next 6 months with the GSK's vaccines franchise in terms of, one, people not coming to do vaccines maybe because they don't want to catch COVID-19? But also if the COVID-19 vaccines themselves have been rolled out now, is there any data that says whether it's okay to get Shingrix vaccination in the same month you've been COVID vaccinated? Or could that be a bit of a near-term headwind?

Yes. Thanks, James. So I mean there's an enormous focus, of course, on deploying these vaccines. So I think if we look at the long-term and the medium-term impact, this is going to be positive for trends around adult vaccination so that we will benefit from that with -- Shingrix will benefit from that with RSV. I think short term, the CDC guidance is pretty clear in terms of needing 2 weeks [ of aside ]. So I think the sequencing is going to be important. But the way I view -- if we have any -- if, for example, a patient is holding off getting the Shingrix vaccine because they want to access the COVID vaccine, to me, that's deferred revenue. That is not lost revenue. So I think it's more a timing question. In the short term, if you look at Bexsero, we had a good strong finish to the year. And I think as schools start to open up, colleges start to open up, that business will stabilize. Flu is very good. And again, I think the whole -- if there are positives to COVID, it's reinforcing to physicians and particularly older patients the importance of protection and adult vaccination. And then if we look just to the background business, I think that will start to stabilize. Pediatrics, for example, that's -- that really stabilized earlier. So net-net, the focus will be on Shingrix. In terms of experiments that would validate combinations, that is something that, as you can imagine, we have predicted this. And we're in the process of generating evidence that would support that.

Maybe one for Iain, which would be in conjunction with the full year results, which is on the 3rd of February, I think you're going to lay out a sort of road map with relation to the consumer separation. So what items might be on this road map in terms of what are we going to see from GSK this year with relation to the separation?

Yes. Thanks, James. Well, an important event on that road map that Hal has already alluded to is an R&D Day that we'll take to everybody in June. So I think that's an important point. But then also just laying out the timetable in terms of the progress from now to the separation of the Consumer Health care company, still very much targeted for around the middle of 2022. So you'll recall, James, that when we did this transaction, the JV kicked off in the middle of 2019. We said broadly within 3 years, we'd separate that company out. Brian and the consumer team have been doing an absolutely first-class job around the integration of that consumer -- the Pfizer business into our Consumer Healthcare business, starting to work now around some of the longer lead time, more complex separation activities. So that is going incredibly well. The teams have stuck with it through 2020 and will do so through '21 and '22 to deliver that on time. So it's really some of those key elements that we'll set out on February 3 about the calendar, if you like, over the coming 12 to 18 months due to that separation, timing of capital market events -- capital market days in addition to that R&D Day, where we'll go into the prospects in detail, clearly, on what is a very exciting prospect in the Consumer Healthcare company, but equally exciting from a biopharma perspective, our pharma and our Vaccines business. So we'll set out the timetable on February about key events over the course of '21 and '22 affecting both the biopharma and the Consumer Healthcare businesses, leading up to the separation of that Consumer Healthcare business with a very strong focus on the prospects for each of those businesses and the building and growing confidence that we've got in the prospects for attractive top line growth and margins for each of those businesses. So that's really what we'll set out in February alongside the full year '20 results, James.

Okay. Thank you very much. I've been messaged to say we're out of time. So thanks, everyone, for joining us, and enjoy the rest of the conference.

Great. Thanks, James.

Thank you, James.

Thank you.