GSK - Q1 2023

Transcript

Operator (participant)

Please turn to slide three. Today's management presentation will last approximately 30 minutes, with the remaining 30 minutes for your questions. For those who wish to ask questions, please join the queue by raising your hand, press star nine to raise and lower your hand if you're on the phone, and we request that you ask one to two questions so that everyone has a chance to participate. Our speakers are Emma Walmsley, Tony Wood, Luke Miels, Deborah Waterhouse, and Iain MacKay, with David Redfern joining the rest of the team for Q&A as we hit the end of the call. Julie Brown, who will officially start as CFO next week, is also with us today on the call in a listening capacity only as part of the CFO succession handover. Turning to slide four, I'll hand the call over to Emma.

Emma Walmsley (CEO)

Thanks, Nick, and welcome to everybody. Please turn to the next slide. Our purpose is clear: To get ahead of disease together by uniting science, technology, and talent. We are preventing and treating disease at enormous scale and delivering a new chapter of growth. As a world leader in infectious diseases, we are also focused on building our business in HIV, immunology, respiratory, and oncology. We're off to a strong start in 2023, showing our strategy continues to deliver for all stakeholders. Excluding COVID-19 solutions, we've delivered double-digit sales growth, including a fifth consecutive quarter of growth across the full portfolio, with excellent commercial performances in vaccines, specialty, and General Medicines. Our adjusted operating profit, excluding COVID-19 solutions, also grew by 5%.

Below the rate of sales growth this quarter due to some one-off factors, as well as planned investment in new launches. Iain will cover this in a moment. Our adjusted EPS grew by 14%. We're firmly on track for our guidance this year. Our clear capital allocation priorities mean we continue to invest for growth and to deliver shareholder returns. The board approved a dividend of 14 pence for the quarter. Please turn to slide six. Our continued commercial success comes with a focus on driving the performance of our key growth products, contributing a new record high 44% of our Q1 sales, adding GBP 500 million of additional revenue versus Q1 of last year. Notable contributions came from Shingrix and our HIV two-drug regimens. Our growth drivers and new launches will support our growth over the decade and beyond.

Our business mix continues to shift to vaccines and specialty medicines, which are now delivering more than 60% of sales. We're confident this shift will progress to around 3/4 of our revenue by 2026. A large portion of the growth is due to our pipeline launches in recent years. New products launched since 2017 delivered GBP 2.2 billion during Q1 alone, underpinning our confidence in continuous future investment in pipeline development. Please turn to slide seven. Our R&D progress is delivering on our priority to strengthen our long-term growth prospects. In infectious diseases, we're advancing our RSV older adult vaccine through the regulatory process. We are on track to get the first U.S. FDA approval in May. We also reported positive data last month on our pentavalent MenABCWY vaccine for adolescents.

We continue to invest in our priority vaccines platforms, including protein-based antigens, mRNA, following some encouraging early data in flu this year, and bacterial platforms like MAPS. In HIV, we presented positive data on long-acting Cabenuva compared to a daily oral medicine, and we continue to enhance our portfolio with business development. In March, we signed an exclusive license agreement with SCYNEXIS to access a first-in-class novel antifungal, adding to our growing anti-infectives portfolio. We're also delighted to announce the proposed acquisition of BELLUS Health last week, further strengthening our specialty medicines and building on our respiratory expertise with a potential best-in-class treatment for refractory chronic cough. We expect to do more targeted business development in the year ahead. Tony and the team look forward to sharing updates on our continued pipeline development and progress throughout the year with a series of therapeutic area-focused meet the management events.

I'll now hand it over to him for some more pipeline details.

Tony Wood (Chief Scientific Officer)

Thank you, Emma. Please turn to slide nine. Our R&D strategy is focused across four therapeutic areas, shaped by our world-leading capabilities in infectious diseases, our understanding of the immune system, and our technology capabilities. Our pipeline today comprises 68 assets in clinical development, around two-thirds of which target infectious disease and HIV. We're making good progress in continuing to strengthen our growth prospects for 2026 and beyond. This quarter, we saw two U.S. FDA approvals, two advisory committees, and several assets progress through clinical development, including a phase II start for our oligonucleotide NASH asset, GSK'990. We also started recruiting into our phase III program for bepirovirsen for the treatment of chronic hepatitis B. Our ambition for BEP is to improve functional cure rates for chronic hepatitis B patients and establish a new standard of care.

We look forward to presenting data from the phase III B-Together trial in the second half of this year. Next slide, please. Elsewhere in our infectious diseases portfolio, we reported three important developments in the quarter. Firstly, we received a positive recommendation from the FDA's Advisory Committee for our RSV vaccine, Arexvy. We remain on track for an FDA decision anticipated by May 3rd. Our phase III RSV study re-randomized subjects for a second season to receive either vaccine or placebo. These second season data will be important to better understand the duration of protection provided by Arexvy. Data collection is ongoing, and we expect a study report around mid-year. Secondly, we announced positive data from our MenABCWY phase III trial, which demonstrated that our pentavalent vaccine has comparable protection to Bexsero and MENVEO, was well-tolerated with a safety profile consistent with Bexsero and MENVEO.

Invasive meningococcal disease is an uncommon but serious infection which can cause life-threatening complications and death. Five serogroups are responsible for most meningococcal infections, there is currently no single approved vaccine which can protect against all five of these groups. Our pentavalent vaccine combines the antigenic components of Bexsero and MENVEO. If approved, it could provide the broadest meningococcal serogroup coverage of the class and a simplified immunization schedule, which we expect will lead to increased vaccine uptake. We will present preliminary data from this phase III trial at ESPID in May. We look forward to sharing these data with regulators to make this important vaccine innovation available as soon as possible. Finally, at ECCMID, we presented positive phase III data for gepotidacin in the treatment of uncomplicated urinary tract infections.

In the U.S. alone, there are around 15 million UTI episodes each year, around a quarter of which are resistant to existing treatments. Gepotidacin has the potential to become the first new class of antibiotics for uncomplicated urinary tract infection for over 20 years. To complement gepotidacin, we've also been active in business development. At the end of last year, we added tebipenem HBr, a novel antibiotic in phase III for complicated urinary tract infection to our infectious diseases portfolio. In March, we agreed to in-license Brexafemme, a novel oral glucan synthase inhibitor approved for treating vulvovaginal candidiasis. Together, these three novel agents will broaden our anti-infective portfolio, an area of significant societal need. Next slide, please. In HIV, we reported data from SOLAR, the first head-to-head study of our long-acting HIV treatment Cabenuva versus a daily oral therapy.

SOLAR demonstrated non-inferior efficacy, a very low rate of virologic failure, and a strong patient preference for Cabenuva, with 90% of participants in the trial expressing a preference for the long-acting regimen. At CROI, we also presented proof-of-concept data from N6LS, our broadly neutralizing HIV antibody. These data demonstrate high potency from a single antibody, even at the lowest dose tested. Our neutralizing antibody is just one asset currently in development as a potential combination partner for cabotegravir. Next slide, please. To augment our respiratory and specialty franchises, we're delighted with our recent agreement to acquire BELLUS Health, a late-stage biopharma company working to better the lives of patients suffering from refractory chronic POTS or RCC. When completed, the acquisition will provide GSK access to camlipixant, a potential best-in-class and highly selective P2X3 antagonist currently in phase III development for the first-line treatment adult patients with RCC.

RCC affects around 28 million people globally and is defined as a persistent coughs lasting for more than eight weeks that does not respond to treatment for an underlying condition. There are no approved medicines for RCC, which has a significant impact on quality of life, with some patients experiencing over 900 coughs each day. Camlipixant has the highest P2X3 selectivity in the class. phase II reported a very low incidence of dysgeusia, a taste disturbance attributed to P2X3 selectivity that frequently leads to patients discontinuing treatment. phase III trials are underway and are expected to read out by 2025. We're confident that the phase III program will confirm a best-in-class profile and provide an excellent addition to our specialty medicines portfolio, building upon our expertise in respiratory therapies. Next slide, please. In oncology, we were pleased to report two significant developments adding to the evidence supporting dostarlimab.

The RUBY trial presented at SGO and ESMO meetings in March demonstrated a 72% reduction in the risk of disease progression or death in the dMMR population of patients with first-line advanced endometrial cancer. In the overall population, preliminary overall survival data showed a clinically meaningful trend and a 36% reduction in risk of death or progression in favor of dostarlimab treatment. Endometrial cancer remains a significant unmet medical need. Over 400,000 new cases are reported annually, with around 15%-20% of patients presenting with advanced disease at the time of first diagnosis. We look forward to sharing these data with regulators as soon as possible. In February, a U.S. FDA advisory committee voted to support our proposed trial design to evaluate Jemperli in treating locally advanced rectal cancer. The trial is now recruiting patients. Next slide, please.

As pipeline momentum continues to build in vaccines, HIV, and infectious diseases, this slide highlights important regulatory events and clinical data readouts anticipated in the next 12 months. A more comprehensive view of the portfolio is provided in the appendix. We anticipate an FDA decision for Arexvy, our RSV older adult vaccine in early May, with additional data to support the vaccine launch, including those from a high-risk 50-59 year-old cohort, additional flu co-administrations, and second season outcomes. In oncology, we anticipate an FDA decision for momelotinib in the treatment of myelofibrosis in June. We also anticipate presenting data from the B-Together phase II trial, which will provide evidence on the durability and response for hepatitis B patients receiving bepirovirsen and interferon. Part of our program to develop a functional cure for some of the 300 million people living with chronic hepatitis B infection today.

The continuous progress we are making underpins my confidence that our pipeline will drive growth in the latter half of the decade. Recent data, pipeline progression, and business development have further strengthened our R&D portfolio, and I look forward to sharing more data with you over the coming quarters and in future meetings. I'll now hand over to Luke on slide 15.

Luke Miels (Chief Commercial Officer)

Thanks, Tony. Please turn the slide to the next slide, Nick. Strong commercial execution in the quarter continues to drive growth across our business. As you can see on this slide, not only are our product areas contributing to growth, but we've also increased sales in each region and provided a balanced, strong portfolio with room to grow. Our improved commercial execution capabilities will play an essential role as we launch new products of value coming through the pipeline and via BD, including RSV vaccine for older adults. Please turn to slide 17. This quarter, we delivered strong performance with sales up 10% excluding pandemic solutions, and in vaccines, strong growth of 9% excluding COVID-19 solutions in the quarter was supported by Shingrix up 11% and meningitis up 25%.

Shingrix delivered another record quarter of sales and a fifth consecutive quarter of growth, including increasing contributions across all geographies. Shingrix is now available in 31 countries, with 39% of sales coming from outside the U.S. In specialty medicines including HIV, which Deborah will speak about shortly, we increased sales by 13% excluding Xevudy to GBP 2.2 billion. In immunology and respiratory, we continue to see growth from our market-leading medicines, Benlysta for SLE and lupus nephritis, and Nucala for severe asthma and other eosinophilic diseases. Benlysta continues to be the leader across all major markets. There's still plenty of growth with about 25% of biopenetration in the U.S. and even less in other key markets. Nucala remains the first and only biologic approved in four eosinophilic diseases, with new indications driving growth and differentiation.

In China, the NRDL listing for EGPA has accelerated momentum, setting the foundation for our upcoming launch in severe asthma. We look forward to our phaseIII COPD data in 2024. In oncology, sales grew 2% to GBP 136 million, despite recent U.S. label changes for Blenrep and Zejula. We remain focused on execution across the portfolio and look forward to the anticipated launch of momelotinib in myelofibrosis following the U.S. PDUFA date in June. Our General Medicines portfolio grew 9% to GBP 2.7 billion. The performance was predominantly reflecting the strong growth of Trelegy across all regions, which grew 28% this quarter.

We also saw a benefit from the strong allergy season in Japan and continued post-pandemic recovery of our antibiotic, Augmentin, which contributed GBP 177 million, further emphasizing our expertise in this space as we move forward with novel antibiotics emerging from our pipeline and BD efforts. Considering this Q1 performance, we now expect general medicine sales to be broadly flat to slightly down in the full year. We remain on track to deliver our existing 2023 sales outlook for vaccine and specialty medicines, and you can find these on slide 35 of the presentation. Please now move to slide 18. As Tony mentioned, we expect an FDA decision for our candidate RSV vaccine very soon. RSV disease remained a significant unmet medical need, and our vaccine data showed exceptional overall efficacy, particularly in the most vulnerable populations.

We expect to be the first approved RSV vaccine in major markets, including the U.S., Europe, and Japan. Our teams have begun disease awareness activities where needed, and our launch preparations are well underway. Overall, we have a competitive vaccine profile with compelling clinical evidence and multi-billion Shingrix-like annual sales potential, and we look forward to keeping you updated as we launch this important vaccine. With that, let me now hand over to Deborah on slide 19.

Deborah Waterhouse (CEO of ViiV Healthcare)

Thanks, Luke. Our HIV business delivered sales of GBP 1.5 billion in the quarter, in the first quarter of 2023, growing 15%. Our performance benefited from strong patient demand for our oral two-drug regimens and long-acting injectable medicines, contributing around 10 percentage points of growth. U.S. pricing favorably contributed around 5 percentage points of growth. The inventory build we saw in the U.S. in Q4 of last year has been slower to burn than initially anticipated. We continue to believe this will burn through during the first half of the year. Dovato delivered GBP 396 million in the quarter. Market performance reflects HCP's belief in Dovato, which has become our number one best-selling medicine in HIV.

We were also pleased to receive EU approval of Triumeq PD in the quarter, the world's first single tablet dispersible regimen for children living with HIV. Turning to Cabenuva. Sales for the quarter were GBP 127 million, reflecting strong patient demand with high market access and reimbursement levels across the U.S. and Europe. Our sales and medical teams are reporting positive customer feedback after releasing the SOLAR data at CROI. Our new direct consumer advertising campaign is currently rolling out across the U.S. Moving on to prevention. Sales of Apretude, the world's first long-acting injectable for the prevention of HIV, delivered GBP 24 million in the quarter. We're pleased by the growing momentum across the U.S. We're encouraged by the progress of our pipeline, which is focused on innovative long-acting regimens.

We have three clear target medicines profiles to provide the world's first self-administered long-acting regimen for treatment, and to provide ultra long-acting regimens for treatment and prevention with dosing intervals of three months or longer. We're excited about the potential of these medicine profiles, and we'll be ready to regimen select in H1 2024. In summary, our Q1 performance positions us well to deliver the mid-single digit growth we expect this year, and we remain very confident in our ambition to achieve a 5-year mid-single digit CAGR to 2026. The changing mix of our portfolio towards long-acting and the success of our pipeline offers the potential to significantly replace the revenue from the dolutegravir loss of exclusivity. With that, I will hand it to Iain on slide 20.

Iain MacKay (CFO)

Thanks, Deborah. As I cover the financials, references to growth are in constant exchange rates unless stated otherwise. As Luke and Deborah have covered the primary revenue drivers, I'll focus my comments on the income statement, including main cost drivers, margins, cash flow, and guidance for 2023, including our latest phasing expectations. Turning to next slide. Before I go into the details of the quarter, I want to provide some context around the key factors influencing the performance of both total and adjusted results. As noted by the team, excluding COVID-19 solutions, we've shown strong operational delivery across the business, growing sales by 10% in the first quarter. Including pandemic solutions, sales were down 8%, mainly reflecting lower sales of Xevudy relative to Q1 of 2022. The 10% sales growth drove 5% adjusted operating profit growth excluding COVID-19 solutions.

This included a 4-point adverse impact from legal charges primarily related to the Zantac royalty dispute. Including the impact of COVID-19 solutions and those legal charges, adjusted operating profit was stable at GBP 2.1 billion. On a total basis, the lower sales, along with the Gilead settlement income of GBP 0.9 billion in the comparator, resulted in operating profit being down 15%. On earnings per share, excluding COVID-19 solutions, there is 14% growth on an adjusted basis. The contribution from COVID solutions reduced this growth rate by 7 percentage points, with adjusted earnings per share up 7% at 37 pence. Total earnings per share were 36.8 pence, down 8% on a continuing basis. Turning now to the main adjusting items of note between total and adjusted results for continuing operations in the quarter.

These were in transaction related with the net credit primarily reflecting the contingent consideration liability movements, the majority of which related to foreign exchange. The currency impact was a favorable 5% in sales and 8% in adjusted earnings per share. Turning to slide 22. Adjusted operating margin was 30.1%. This was a 250 basis point improvement versus Q1 2022 at constant exchange rates. The improvement was primarily a function of the factors I've already described, with lower sales at low margin Zantac benefiting cost of goods sold, partly offset by higher SG&A, which included the legal charges primarily related to the Zantac royalty dispute. In addition to these factors, there was continued commercial and pipeline investment behind key products. Turning to the key cost line dynamics for the quarter.

Within cost of goods sold, the 9.1 percentage point margin benefit was primarily from lower sales of low-margin Zudene, but was partly offset by an unfavorable comparator to a one-time benefit from inventory adjustments in Q1 of last year, as well as higher freight costs. SG&A growth was ahead of sales and had an adverse 4.9 percentage point margin impact. This primarily reflected launch investment, particularly focused on HIV and Shingrix to drive demand and support market expansion. There was also increased investment in preparation for the anticipated launches of our candidate RSV vaccine and momelotinib later in the year. The aforementioned increased legal charges added four percentage points to SG&A growth in quarter. R&D spend grew 6% with continued investment across a combination of both early and later stage programs, particularly in vaccines and specialty medicines.

Within vaccines, this was driven by our pneumococcal, mRNA, and phase II MMR programs. Within specialty, the early stage key assets included CCL17 for osteoarthritic pain and IL-18 for immune-based diseases. In later clinical phases, there was a higher investment behind Tremfya, momelotinib, depemokimab, and bepirovirsen as those programs progressed. These dynamics were partially offset by decreases related to completion of late-stage clinical development programs for otilimab, cell and gene therapy discontinuation, and reduced R&D investment in Blenrep versus Q1 of 2022. Royalties benefited from Bicari's contribution, which included an additional month in 2023 versus last year. Note that our Gardasil royalty stream will cease at the end of this year. Next slide.

Moving to bottom half of the P&L, I'd highlight that net finance expense mainly driven from the net savings from maturing bonds, including the sterling notes repurchase in fourth quarter of last year and higher interest income on cash. That non-controlling interests were lower due to Q1 2022 other non-controlling interests not repeating. This was as expected. On the next slide, I'll cover cash flow. In the first quarter, there was a free cash outflow of GBP 0.7 billion. Within free cash flow, cash generated from operations decreased GBP 287 million, down 88%. This primarily reflected an unfavorable comparison due to upfront income from the settlement with Gilead received in first quarter of 2022, and the unfavorable timing of profit share payments to Vir Biotechnology related to sotrovimab.

There was also increase in seasonal inventory and lower payable balances reflecting increased investments in 2022. Below cash generated from operations, there were higher tax payments. Q1 performance and cash generation was in line with expectations and we're on track to deliver outlooks this year. Turning to slide 25 and considerations for our guidance for 2023. We delivered a good start to the year and are very much on track to deliver full year guidance. Given Q1 performance, we now expect full year phasing to be slightly different to that shared in February. Our Q1 performance benefited from slower than expected HIV inventory burn, and particularly strong general medicines delivery due to anti-infectives market recovery and Japan allergy season dynamics, which we don't expect to persist through the year.

For the second quarter, we expect to see destocking in HIV and for General Medicines growth to moderate due to the seasonal effects. We therefore expect sales growth in Q2 to be lower than Q1. Within this, we now expect first and second half sales growth to be broadly similar. Within this, we now expect General Medicines to be broadly flat to slightly down for the year. In the second half, we continue to expect the sales growth to be influenced by the comparator periods. In HIV, these included U.S. channel inventory build and favorable U.S. pricing, particularly in Q4 of last year. In Gen Meds, there was a post-pandemic recovery in the antibiotic market and the launch of Flovent authorized generic in the U.S. in the second quarter of last year.

For this year, we would also expect ongoing pricing pressure in Gen Meds, especially in the U.S., and European pricing pressure in the HIV market. With respect to operating profit growth, we still expect this to be lower in the first half of the year compared to the second half relative to full year expectations. This is informed by continued investment behind ongoing and anticipated launches, including our RSV vaccine and momelotinib. As such, we expect SG&A to grow ahead of sales in Q2, and we still expect SG&A to increase at a rate broadly aligned to turnover for the full year. On COVID-19 solutions, we still do not anticipate significant future sales. Based on Q1, we are revising the estimate up for full year adverse adjusted operating profit impact to be 5-6 percentage points. We're off to a good start in 2023 with good momentum.

With that, I'll hand it back to Emma.

Emma Walmsley (CEO)

Thank you, Iain. Turning to slide 27. We have made building trust by operating responsibly an integral part of our strategy and our culture. Ultimately, we are focused on delivering sustainable growth with returns to shareholders, reducing risk, helping our people to thrive, and delivering health impact at scale. Our responsible business framework prioritizes six material areas. Last month, we published our ESG performance report on our progress in each, including a new overall ESG rating that showed we're on track based on 83% of all performance metrics being met or exceeded. On access, one of the most material areas of social responsibility in our sector, and one where we are committed to lead, we made further progress again by expanding availability of our HIV prevention medicine, cabotegravir, to 90 countries by signing an agreement with generic manufacturers via the Medicines Patent Pool.

We've also enhanced recruitment of diverse patient populations with 100% of our phase III clinical trials now including a demographic plan, as well as also making great progress in creating a diverse, equitable, and inclusive workplace. Turning to the final slide, 28. We are off to a strong start in 2023 with all our growth drivers performing. We're very focused on our upcoming launches, including our potential RSV or the adult vaccine, and on continuing to strengthen our pipeline organically and through targeted business development in vaccines and specialty medicines. Our continued momentum commercially and in the pipeline support our confidence in delivering on our outlook and ambitions to sustain our growth through this decade and beyond. We look forward to showing more details at upcoming events.

Before closing, of course, I would like to recognize the outstanding contributions made by Iain MacKay as our CFO. This will be his last quarter. Indeed, it's his last week before retiring from GSK. Ian has been a fantastic leader, great colleague, and has made an enormous impact in his time here. I really want to sincerely and personally thank him. Julie has been transitioning into the role with Ian and is officially starting in just a few days. I know she's very much looking forward to spending time with you all as we continue to deliver progress together. With that, Nick, now I think you're the master of ceremonies. Can we move to the Q&A?

Operator (participant)

Absolutely. Thanks, Emma. Just as a reminder, if you'd like to ask a question, please join the queue by raising your hands. Alternatively, press star nine to raise and lower your hand on the phone. Given that there are currently 15 people polled for Q&A, can I ask that you please keep questions to one to two, so we at least give everyone the opportunity to participate. With that, our first question is coming from James Gordon. Please go ahead, James. James, you may need to press star nine to unmute

Okay. What we'll do is we'll move to Kerry Holford. Kerry, over to you, please.

Kerry Holford (Head of Global Pharmaceutical Equity Research)

Hi. Can you hear me, Nick?

Operator (participant)

Yes, we can.

Emma Walmsley (CEO)

We can.

Kerry Holford (Head of Global Pharmaceutical Equity Research)

Excellent. Lovely. A couple of questions, please, on camlipixant. Tony, you highlighted that around, what? I think you said 28 million people suffer from RCC globally. I'm wondering, are there perhaps specific patient subgroups and/or markets that might be most amenable to drug therapy in this disease, perhaps more severe patients? Then I'm wondering whether you're willing to discuss potential peak sales that you might target for this asset. I might just chuck in a last one. Competitor Merck has clearly faced issues with efficacy measurements in this space. How confident are you that your asset here won't suffer the same fate? Thank you.

Emma Walmsley (CEO)

Thanks very much, Kerry. This is camlipixant, obviously delighted to have announced the deal with Veles. I'm going to ask Luke to pick up on the dimensions of opportunities in subgroups. I mean, it's $28 million, but there are more than $10 million who've been living with this for more than one year. We are very excited about the best-in-class potential and the meaningful contribution that will come after a 2026 launch. Luke, I know you've been very close with all of this from the beginning, so perhaps you could comment on the relative competitiveness of chances.

Luke Miels (Chief Commercial Officer)

Sure. Thanks, Emma. Thanks, Kerry. I think the important thing here is there's a temptation to focus on the 28, so that's all people that, you know, technically had cough for more than eight weeks. In our modeling of the peak sales and the uptake, we concentrated exactly to your point on subgroups. You know, people who have had refractory cough for longer than one year, so they're more likely to present at a pulmonologist. We've taken various other cuts around access, compliance, et cetera. You get, as we put in our slides announcing the deal, it's about 3.3 million potential patients in the U.S. and around three in Europe, and about half of that in Japan.

It's quite a sizable group. What is interesting, when you look at numbers being managed right now by pulmonologists, about 1.8 million patients being managed right now by pulmonologists in the U.S. with RCC. Now, the true number is actually higher because many of them, unfortunately, are sent back to the primary care physician because there's limited options in terms of resolving that. That's why we think this is a multi-billion product. What I would encourage you to do is if you have discussions with physicians treating these patients, the two things I'll tell you, one, frustration in terms of the options available, and then secondly, unprompted, they'll remark on the large volumes of patients that they see. You assemble all these things, it's a very compelling asset.

I think versus Merck, I'll let Tony comment on the filing. The pharmacological profile and the selectivity around P2X3 versus P2X2, this is an incredible, you know, incredibly durable, robust differentiation even if we have equivalent efficacy. Of course, the upside is that we have an edge on efficacy versus Merck. The tox profile is just so much more compelling for the Merck product. Then again, that's the third thing that physicians make a point around in terms of the class. Tony.

Tony Wood (Chief Scientific Officer)

Yeah. Luke, just to underscore that point, two things about the Merck comparison. To put some numbers around selectivity, the unpleasant taste dysgeusia, which is a significant impact on patients discontinuing therapy, is driven by selectivity over the P2X2 receptor class, for which camlipixant has a 1,500-fold margin. That's an enormous margin relative to the class and of the order of 150 times greater than the Merck molecule. We're very confident in our ability to improve side effects with regards to that particular selectivity. Indeed, you see that in the phase II studies where there's only a 6% incidence of dysgeusia for camlipixant. The other issue is with regards to a data treatment or analysis issue associated with the cough counter device. We have exactly the same device and approach as Merck.

As far as we can tell, their CRL was based on the methodology used for data analysis, where we are on ongoing conversations with the regulator and we're confident that we'll be able to work through that data treatment issue, particularly given the medical need for this area that Luke emphasized.

Emma Walmsley (CEO)

Well, next question please, Nick.

Operator (participant)

Next question is from Steve Scala. Steve, over to you please.

Steve Scala (Pharmaceutical Analyst)

Thank you. Can you hear me?

Emma Walmsley (CEO)

Yeah.

Tony Wood (Chief Scientific Officer)

Mm-hmm.

Steve Scala (Pharmaceutical Analyst)

First I'd like to clarify, when does GSK plan to initiate phase III trials in adults and infants for the 24-valent pneumococcal vaccine? It is still listed as a 2024 readout, but it's not identified as a catalyst any longer in 2024. Thank you.

Emma Walmsley (CEO)

Thanks, Steve. Straight to you, Tony.

Tony Wood (Chief Scientific Officer)

We will start the phase III study for adults with the pneumococcal 24-valent vaccine at the beginning of next year. That represents an acceleration relative to the acquisition objectives. You'll have noted that we have a pause in our 24-valent infant program. This is associated with an audit finding with regards to the fill finish and presentation of the vaccine. We are still very confident in the overall profile of the vaccine. In fact, our confidence in the technology continues to grow as we see emerging data from competitors in the field. I'm very confident with progression here. We're working to get the 24-valent infant vaccine study back on track as soon as possible.

Emma Walmsley (CEO)

Thanks, Tony. Next question, please.

Operator (participant)

The next question is from Graham Parry at Bank of America. Over to you, Graham.

Graham Parry (Senior European Pharmaceuticals Equity Analyst)

Great. Thanks for taking the questions. Firstly, just on RSV vaccine, just any kind of level of confidence you can give over the likelihood of approval into the AdCom next week. In particular, Guillain-Barré syndrome is obviously raised in both the AdCom and the ACIP meeting. Whether there's been any further requests for data or information relating to that? Secondly, the timing of the two-season data. I think you said data collection ongoing and update mid-year. Has the FDA requested you to see any of that data? Do you think you'll have that data in time for the June ACIP meeting? How does that play into pricing decisions ahead of launch?

If you have that data, but it's not a part of a June ACIP recommendation, can you price this for a 2-year vaccine at the outset, or are you gonna have to start thinking about sort of adjusting pricing post-launch, for example?

Emma Walmsley (CEO)

Thanks, Graham. I'll come to Tony first and then Luke on the specifics of pricing, recognizing that, when you're a week away from going through the regulatory process, pronouncing what's going to happen, you know, we'll have varying degrees of specificity on that, and likewise in a competitive situation on pricing. Both of those we should respond to, too.

Tony Wood (Chief Scientific Officer)

Where I might start, [James], is just emphasizing the profile of our vaccine. I'm sure you will recall, particularly with regards to the at-risk populations, with regards to hospitalization, where we see 94% vaccine efficacy. That profile for efficacy and the overall safety profile, of course, was recognized in the VRBPAC vote for our vaccine, which we were delighted to see. We continue to randomize patients on the phase III study. We randomized it for the second season to receive second vaccination and placebo, which gives us the opportunity to make an appropriate comparison with regards to second season data. I'll remind you, in the first season that our data acquisition was determined by event rate. For the second season, it's determined by the close of the season.

We remain on track to acquire that data along with other data that we are building the picture for the quality of our vaccine, in particular, data for flu co-ad, where we'll be moving into the high dose and adjuvanted setting. Again, I'd remind you that on the basis of data we have so far, we are the only vaccine for which coad shows no impact on the performance of either vaccine. We're also adding data from the at-risk 50 to 59 population. We expect to have all of those data ahead of ACIP, as Emma indicated. Luke, perhaps I can hand over to you with regards to the question for pricing.

Luke Miels (Chief Commercial Officer)

Thanks, Tony. Thanks, Graham. You know, to reinforce, Tony's and his team are incredibly focused on those timelines. Our working assumption is that we have that. You know, in an unusual scenario that we just missed a deadline, which as I said, we do not expect, I think it would depend on the robustness of the signal. My working assumption is if we had that second season, we would price it at the upper end of the range. We've signaled in the past that the range is somewhere between high-dose flu, which is in the $60s, and Shingrix, which is $185. Of course, it's now moving more towards the right-hand side of that midpoint, if we had that second season, we'd be very much on the right-hand side of that midpoint.

Emma Walmsley (CEO)

Thanks, Luke. Next please.

Operator (participant)

Next question is from Richard Parkes at BNP Paribas.

Richard Parkes (Pharmaceuticals and Biotechnology Equity Analyst)

Hi. Thanks, Nick. Hopefully you can hear me okay.

Emma Walmsley (CEO)

Mm-hmm.

Richard Parkes (Pharmaceuticals and Biotechnology Equity Analyst)

Just got two questions. Firstly on Shingrix, I just wondered if you could disclose what underlying U.S. volume demand growth was when you x out the stocking differences, and maybe you could just update us on ex-U.S. launches where you're seeing most traction and how that'll evolve through the year. Second question was for Tony on business development and R&D. Many of the recent transactions have added late-stage programs, such as momelotinib, camlipixant, that will help cushion patent expiries that you'll experience later in the decade. They don't necessarily bring platforms or technology that can help to improve GSK's longer term R&D productivity.

My question for Tony is, now that he's been in the seat a little bit longer, if he feels confident GSK's invested enough through business development to retool the company in terms of technology platforms and capability for it to be competitive and improve internal R&D productivity longer term. Thank you.

Emma Walmsley (CEO)

Thanks very much, Richard. Obviously I'll ask Luke to comment on Shingrix, where we still see a lot of growth ahead. Then we'll come to Tony. I mean, we remain. You said, is it, have we done all we need to? This is always an ongoing piece of work, and it's always at the core of our strategy in R&D. You're absolutely right, we are focused both on assets and on platforms, but Tony can make some more specific commentary on where we're at. Luke, to you first on Shingrix.

Luke Miels (Chief Commercial Officer)

Thanks, Richard. In terms of the market research, if we look at pharmacists, Shingrix is now our number one priority, and some of the challenges that they had around staffing and elements like that have been resolved. If we look at primary care physicians intention to recommend vaccine, again it remains unchanged. All of those things are pointing in the right direction. If we look at TRXs, over 60% of them are 1st dose, which again is very consistent. These are all encouraging elements. In terms of Q1, it was influenced by two distinct events which I think will start to be washed through in Q2. The 1st one was we had an inventory unwind versus Q1 2022. In Q1 2022, it was 0.9. This quarter it was 0.6.

As we've discussed on lots of calls before, you know, the steady state is around 1 to 1.2 million doses a month. We expect, and there are signs that that's normalizing now. Then the other thing is linked to that, you know, the strength of retail is very much driven by the 65 and above, which you would expect with the removal of the co-pay. As you know, commercial patients don't have a co-pay. Then the second element influencing this is that we had a lower non-retail Q1 performance due to a very specific element, which I won't go into, but it is thoroughly addressable. We expect to recover those patients in Q2. You put those two things together, that's what explains the numbers.

As I said, very strong. If we look ex-U.S., you know, 39% of the growth. We continue to pick up reimbursement decisions. We've got expansion in Japan. We've just picked up Australia and a number of markets in Europe. We're now really starting to get traction on. Early days in China in terms of the recovery. Of course, in the long term we're very focused on the booster in that IC population, but also potentially people with an additional comorbidity to come back and re-challenge the original cohort.

Emma Walmsley (CEO)

Thanks.

Tony Wood (Chief Scientific Officer)

Great. Then in terms of technology platforms, I'm delighted with the platform access we have and the progress we're making. I might start actually in the vaccines area, and refer again to Affinivax, which I feel is the leading protein complexation technology that's available. We're obviously making great progress in our partnership with CureVac and with regards to RNA. You saw some of the data that is exciting us in phase I, at least in the context of flu and COVID earlier in the year. Add that to our already existing capacity in vaccines with protein subunit structure-based vaccine design and adjuvants illustrated nicely through the RSV vaccine that we've just been talking about, and I think we're in an extremely solid position.

With regards to vaccines technologies, you'll remember that we added in the medicines part of our business, we added access to what we believe is the strongest oligonucleotide platform at the moment in the context of a multi-target deal with Wave Life Sciences. As far as what I would refer to as platform technologies, I think we're in excellent position. We obviously, as Emma indicated, remain vigilant to further areas of development. In data technology, I would add collaborations like the one that we signed with Tempus recently, which will be about helping us to identify patients in oncology and to spot the right combinations. Obviously, they go on top of existing collaborations in data and human genetics and functional genomics like 23andMe and LGR, for example, giving us access to cutting-edge technology.

I think we're extremely well placed across the board with regards to both platform and data technology, although you will continue to see that as a theme of business development as I look to augment capabilities when appropriate, target identification needs emerge in the portfolio.

Emma Walmsley (CEO)

Great. Thanks, Tony. Nick.

Operator (participant)

Next question is from Andrew Baum of Citi. Andrew, please go ahead.

Andrew Baum (Head of Global Healthcare and Managing Director of Equity Research)

Yeah. Thank you. Couple of questions. First for Deborah on ViiV. Could you talk to the anticipated impact of the rollback of continuous enrollment under Medicaid on ViiV? My assumption is the economic impact for the group is gonna be limited because of the lower profitability and programs like Ryan White will plug the gap as anyone loses coverage. If you could tell me if those assumptions are incorrect. Second, for Luke, you've spoken about the potential for line-agnostic indication for momelotinib in MFS. We're waiting obviously the label. I'm sure the NCCN has already reviewed the data. Assuming that you do get line-agnostic approval, do you have any sense of which category recommendation NCCN will rate if you are to challenge Jakafi in that setting? Thank you.

Emma Walmsley (CEO)

Right. Deborah and then Luke.

Deborah Waterhouse (CEO of ViiV Healthcare)

Great. Thanks, Andrew. I think you're talking about the Braidwood ruling when you're talking about some of the challenges externally in the environment. If not, stop me. Basically, the Affordable Care Act mandates coverage by commercial payers so that they cover preventive services without cost-sharing, which is very important. A number of employers with strong religious beliefs don't want commercial insurers to cover PrEP in HIV, and a judge in Texas found in favor of the plaintiffs. Therefore, the Biden administration has actually appealed against this judgment because actually it doesn't just tackle HIV for PrEP, but actually it's really undermining one of the core planks of the Affordable Care Act that preventive services would be covered by commercial insurers.

It's got a number of different layers and that court case, which I think will go all the way up to the Supreme Court, probably gonna take two years. From our perspective, there's two things. We don't think there's gonna be short-term impact. We're gonna watch and wait to see what happens in the court case. Also, obviously, we work very closely with the community and with the various bodies in the kind of the U.S. administration. Their view is that they are going to put in place policy and other reforms to ensure that the Affordable Care Act mandate around prevention remains in place because of their commitment to it.

The other thing that's slightly ironic is obviously the government and in fact, it's bipartisan, the commitment to ending the HIV epidemic.

Has set a goal of ensuring that 50% of people who are eligible for PrEP, so that's about 600,000 people of the 1.2 who are at risk, should be prescribed PrEP by 2025. It's not just butting up against the Affordable Care Act mandate, but it's also undermining the ending the HIV epidemic initiative. We know from all of our government partners they are gonna fight to maintain this very strongly, and they've got some clear things that they're gonna do from a policy perspective and other reform options to make sure this isn't impacting their mandate. For me, it's a watch and wait, but I'm not expecting any short to medium term impact. Let's see how it plays out.

Emma Walmsley (CEO)

Thanks, Deborah. Luke, momelotinib.

Luke Miels (Chief Commercial Officer)

Yeah. Thanks, Andrew. As you know, the base case for the deal was second line anemia patients, so JAK-exposed with anemia. Anything, if we did get a first line label, you know, there's clearly an upside there. I will have to bite my tongue. I don't wanna speculate because as you can imagine, we're in discussions with a number of people right now. What I can tell you know, we are very clearly stating that momelotinib, of course, is the only agent with profound clinical and a durable benefit in terms of spleen response and symptom relief with patients with anemia. I think that is landing incredibly well. If we look at unaided awareness coming out of ASH, it's quite striking.

It's around 32%, which is double the typical benchmark in hematology. When you look at aided awareness, it's around 75% of physicians. What is also interesting, we're not actively out there making this point, but already you've got 60% of treating physicians indicate that one of the top three reasons that they switch patients is because of issues with anemia and transfusion. It's a very fertile environment for us to arrive in, and we're hoping that the NCCN recognize that in terms of the labeling and language and the guidelines.

Deborah Waterhouse (CEO of ViiV Healthcare)

Very much looking forward to that launch.

Emma Walmsley (CEO)

Yeah.

Operator (participant)

Thanks, Emma. We've got eight minutes left. I'm mindful that there is another call starting at 1:00 P.M. If you can keep your questions short, that would obviously be appreciated so that we can.

Emma Walmsley (CEO)

We'll try with the answers too.

Operator (participant)

Exactly. James, back to you at JPMorgan, please.

James Gordon (Executive Director and Senior Equity Analyst)

Hello. James Gordon, JPMorgan, thanks for putting up with my earlier IT meltdown. Two questions, one on Zantac and one on M&A. Sort of linked together though. The Zantac said that the saga on hearing wasn't quite as positive as the MDL, but latest thoughts on what that could mean in terms of liability and when this all could get wrapped up by. Given the needs to maybe have some funds to address any potential Zantac damages, are you a bit sort of stint up on BD for a while? Is there still room to do much more BD, or do you have to set aside some funds there? Could you put the Haleon stake to work? Could you sell that so then you've got the ability to do some more BD?

The second question on also on BD and M&A.

Emma Walmsley (CEO)

I think that was three, but yeah.

James Gordon (Executive Director and Senior Equity Analyst)

The other question, which is the therapeutic strategy. I think it was more oncology, and then I thought the focus was more infectious disease.

Emma Walmsley (CEO)

Mm-hmm

James Gordon (Executive Director and Senior Equity Analyst)

To me looks a bit more like Gen Meds with respiratory.

Emma Walmsley (CEO)

All right.

James Gordon (Executive Director and Senior Equity Analyst)

Could it be more of a focus now?

Emma Walmsley (CEO)

There's absolutely no change in our focus here, James. But let me try and succinctly respond to that. First of all, no news, new news on Zantac. Very confident in our position. Obviously, respectfully, disagree with the conclusion in California. We're gonna work through that case that's coming up in the summer. Delighted with the federal dismissal at the end of last year and continue to defend our position vigorously. Completely independent of that, BD remains absolutely core in terms of our R&D strategy. It is part of the way, like the rest of the industry, that we do R&D. It's been one of the biggest changes we've driven in the company over the last few years. Delighted with the deals that we've announced recently.

As you alluded to, it was absolutely core to the structural transformation that we've made of this company, with the demerger of Haleon and the resetting of the balance sheet, a new step change in operating performance to generate more cash and obviously competitive, but appropriate, distributions direct to shareholders as well, which has created all of this capacity which we are deploying, we think smartly in ways, with a lot of financial discipline that's contributing meaningfully to our growth. You know, we are confident of great momentum this year, the five-year outlook, and we're looking forward to adding to that the growth ahead. There is total consistency in terms of what we've said we are prioritizing, in terms of our BD. That is vaccines and specialty meds as the core priorities.

That doesn't mean we haven't taken advantage, particularly in building out our anti-infective priority because, you know, we are, we do have expertise in infectious disease, and it's such a core global unmet need, the silent pandemic that will kill 10 million people a year if the industry doesn't address antibiotics. We've got a nice set of tuck-ins that Luke has led for us there. The core priority is vaccines and specialty, assets and platforms. Within our TAs, we have four that we work on, infectious diseases, HIV, immunology, respiratory, and of course, oncology, which is a small but emerging area for us where we've been pragmatic and we've just talked about momelotinib, which we're excited about coming up for. Hopefully that covers all of your questions. The next one please.

Operator (participant)

Next question is going to come from Seamus Fernandez at Guggenheim. Seamus, over to you.

Seamus, are you there?

Seamus Fernandez (Senior Managing Director)

Yep, I'm just getting the instructions on how to unmute. Just one question. Really wanted to get a sense of the company strategy in flu with mRNA, you know, how you're thinking about the competitive landscape. We just got some, I guess, mixed data from competitor Moderna, you know, at their recent vaccine state, we'll get some additional data in the back half of this year. Just love to see how you're thinking about the mRNA flu opportunity for GSK, and what you're seeing as it relates to the competitive landscape. Thanks so much.

Emma Walmsley (CEO)

Sure. Well, I mean, let's start by saying we're excited about mRNA technology, the early data we've seen, and we expect to continue to invest more in mRNA as our portfolio. I think in terms of the competitive landscape, maybe Luke, you could just comment a little bit on how we see that.

Luke Miels (Chief Commercial Officer)

Sure. I mean, as you know, we have no presence in high dose. Anything that we can extract and penetrate there is upside. You know, our working assumption is that there will be a tolerable mRNA vaccine developed, and of course, we have the partnership with CureVac. I think the advantage of mRNA, of course, is just the speed at which you can go from bench to the clinic, and that is not relevant for areas like shingles, but it is profoundly relevant when you're seeking to select strains and predict a future season. Any compression enabling greater certainty in terms of the leading hemisphere to select those strains is going to produce a more effective vaccine and hopefully shift it above 50% that we see in a typical year.

Our working assumption is it's gonna be very disruptive, and I think the combination of COVID in the partnership with CureVac is also very attractive. Our expectation is that the urgency around COVID is going to be reduced, but flu is going to be durable, and therefore two plus one vaccine is attractive. I don't know, Tony, if you wanted to mention anything in terms of the program that we've got. I mean

Tony Wood (Chief Scientific Officer)

Yeah. Just to underscore the point that Emma made at the beginning. If we look at the developments in mRNA in the field in general, I think they're all adding up to the need and importance to secure therapeutic index with regards to the gap between immunogenicity and reactogenicity. As I mentioned earlier, the data that we disclosed or that our partner CureVac disclosed earlier this year, I think gives us a good start with regards to expectation that both sequence modification and use of modified bases are gonna give us a strong position there.

Emma Walmsley (CEO)

Great. Nick, any time for any more?

Simon Baker (Partner and Head of Global Biopharma Research)

Last question. Apologies to those that we weren't able to get to, our last question comes from Simon Baker at Redburn. Simon, over to you, please.

Emma Walmsley (CEO)

Hi, Simon.

Simon Baker (Partner and Head of Global Biopharma Research)

Thank you. Thank you, Nick, for taking the question. I'll be brief, but just quickly wanted to get a quick note of thanks in for Iain for all the help and assistance he's given us-

Emma Walmsley (CEO)

Lovely

Simon Baker (Partner and Head of Global Biopharma Research)

-over the years. Two quick questions. Firstly, on camlipixant. Although RCC is obviously a very big indication, I just wonder if you'd give us any thoughts on potential beyond RCC, given P2X3's implications in areas like overactive bladder and endometriosis. Secondly, on gepotidacin. A fabulous job on the development side. Arguably, the big challenge to come is on commercialization. Luke, I just wonder if you could give us some thoughts on how you think about selling a new differentiated antibiotic, which historically has been somewhat of a commercial challenge. Thanks so much.

Emma Walmsley (CEO)

It's a great point because I know there's been an enormous amount of thinking from Luke and his team on the dynamics across our anti-infectives portfolio, where we are confident we're gonna deliver financial returns. We'll come to you in a moment on this. Perhaps first, Tony, you can comment on lifecycle innovation possibilities on camlipixant, by the way, also, which is primarily a female patient profile as well in RCC.

Tony Wood (Chief Scientific Officer)

Yeah. Look, Simon, hi. First of all, of course, our focus in camlipixant is increasing the degree of penetration into the enormous unmet need for the 30 million patients that suffer from refractory chronic cough. I'm sure you followed this. If you looked at the colocalization of the P2X3 ligand-gated ion channel with regards to sensory afferents, you could imagine utility and pain, migraine, urinary incontinence. Our focus is really to establish the profile of the molecule in phase III in RCC, where we see the biggest need and immediate opportunity.

Luke Miels (Chief Commercial Officer)

Thanks, Simon. I think we're very excited about the profile that's been achieved in phase III with Tony's team. You know, if you look at typical broad-spectrum antibiotics, they are reserved because as you would expect, people wanna retain potency and avoid resistance. There's also incentives around, you know, in hospital use in terms of DIG disincentives that don't come into play here. I think that the main argument, if someone was to challenge on, you know, the risk of resistance, is gepotidacin has been developed specifically for pathogens that are resistant in and limited to use in uncomplicated UTI and gonorrhea. It's not a reagent that's gonna be used for, you know, postoperative infection, staph, et cetera.

The other problem we have is if you look in the U.S., there's around 15 million episodes a year. About a quarter of those are recurrent, and they're resistant, or the patient is allergic or intolerant for three or more antibiotics. This is a growing group. The typical strategy, of course, is to try nitrofurantoin and others, but about a quarter of these patients' physicians employ fluoroquinolones, which, as you know, are a broad-spectrum antibiotic. They're actually contributing to the problem. Our argument is displace fluoroquinolones, use gepotidacin, which has a much lower risk of resistance, and of course, you're not destroying activity in other pathogens which could be used for more aggressive infections. You've got the commercial scale that we can bring.

The logic, as Emma has outlined, of assembling tebipenem HBr, and gepotidacin, and Brexafemme is that we get enormous synergy across the specialty groups and the primary care doctors that are treating these patients.

Emma Walmsley (CEO)

Thanks, Luke.

Simon Baker (Partner and Head of Global Biopharma Research)

Thank you.

Emma Walmsley (CEO)

All right. I think that wraps up our call today. Great start to 2023 with all growth drivers performing and good momentum. Very focused on the upcoming launches, and continuing to strengthen our pipeline organically and inorganically, all of which underpins our confidence the outlook's ahead. Thank you, everyone. Speak to you soon. Big thanks.