GSK plc Virtual Management Event: Getting Ahead of Infectious Disease Transcript

The following is excerpted from the question-and-answer section of the transcript.

Question: Colin Peter White - UBS Investment Bank, Research Division - Analyst : Can you hear me? Josh Williams Yes, loud and clear.

Question: Colin Peter White - UBS Investment Bank, Research Division - Analyst : Yes, I think was around the timing. And then it was the Candida auris for Rob afterwards. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 27, 2023 / 1:00PM, GSK.L - GSK plc Virtual Management Event: Getting Ahead of Infectious Disease Kumaran Vadivelu Okay. So we have just completed Phase I trial for the pediatric 24-valent vaccine candidate. The ongoing Phase II trial, which started in June 2022 is temporarily paused following an audit finding related to the fill and finish presentation of the vaccine. But I want to reassure you, we are very reassured by the Phase I data we have seen in this population. It validates the technology potential in young infants, and we are working diligently to resolve this matter as soon as possible to resume Phase II study. Josh Williams Thanks, Kumaran. Rob, over to you. Rob Bowers Yes. Thanks for the question. So the key study that we're using for invasive fungal infections is the [MARIO] study. That's active as we speak. It's an oral step-down study that's live, and we're expecting that to read out in early 2025, and we'll then be sort of filing after that. To your point about how big an opportunity is that? At the moment, we see the bigger initial opportunity in the U.S. in the VVC space initially. But that the importance of the invasive fungal infection is not to be underestimated. And actually, ex U.S., that will be most likely the bigger opportunity. Josh Williams Thanks, Colin. Just give it another moment if anyone else has got a raised hand. In the interim, unless Colin has left his hand up for another question, don't know if that's the case, Colin? That's fine. No worries. Thank you. In which case, one of the questions that we often get to the Investor Relations team and during engagements is kind of one for you, Rob, which is -- you've got the portfolio. We have the portfolio of 3 anti-infectives, and we've now kind of attributed this around 2 billion peak year sales potential, but people don't always necessarily understand why we're that confident in that level. So perhaps you could run us through some of the key reasons to believe in some of the key factors that are driving that kind of -- that estimate. Rob Bowers Yes, sure. And I think I sort of shared these synergistic strategies. I think all 3 of these medicines share common factors. I think the first is that they all address large populations with these 15 million episodes of UTI in the U.S. every year. There's 3 million complicated urinary tract infections. There's 10 million VVC infections. So these are large initial populations to work with. And then what I also shared is there's very, very clear populations with important unmet needs. Generally, across all 3, you're looking at resistant populations or recurrent populations and resistant to recurrent to the existing standards of care. And therefore, what we're bringing with these medicines is essentially a unique option where no alternates exist. So for example, in complicated UTI, 3 million cases a year, nearly 20% have this ESBL infection, which has no alternative oral option. And so with tebipenem, you've got the ability to introduce a medicine there, which means patients can get out of hospital quicker or prevent their admission in the first place. So I think they all share those 3 factors in common. And if you've got economic tailwinds, like you have for tebipenem, it makes a real kind of commercial sense as well as addressing a really important patient unmet need. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 27, 2023 / 1:00PM, GSK.L - GSK plc Virtual Management Event: Getting Ahead of Infectious Disease Josh Williams That's great. Thank you, Rob. (Operator Instructions) And whilst people maybe consider what they want to ask, maybe, Kumaran, I'll go to you just quickly, just again, kind of similar question in terms of, what are the key reasons to believe that our pentavalent meningitis' candidate is going to be differentiated and grow the market? Kumaran Vadivelu Yes. Thanks. We view the MenB component as the distinguishing factor between vaccines. We think the ABCWY components are highly similar across various products. So we feel confident that Bexsero's proven track record of robust clinical data, real-world effectiveness will be reflected in customers' preference when it comes to MenABCWY combination vaccine. And another reason to believe that MenABCWY will transform the space is today, the MenB vaccination coverage for 16- to 18-year-olds stands around 30%. And with the introduction of combination vaccine, we believe we can increase the coverage closer to what MenABCWY vaccine has achieved, which is around 60%. And that's what we see as a great opportunity to potentially double the number of people receiving MenB vaccine over time. Josh Williams That's great. Thanks, Kumaran. Again, I'm going to make a call, see if there's anyone who would like to raise a hand and come off mute and ask a question. If not, we might actually call the session and give everyone a 5-minute break before the collective Q&A back in the main kind of plenary session. So I'll just pause for a moment there and give people the opportunity. Okay. In which case, I think -- thank you very, very much to everyone for attending and listening to the presentation and to the Q&A. And I'd also like to extend a big thank you to our speakers as well for their great presentations. You now have about 5 minutes before the group Q&A and the final Q&A session begins, which starts at 15:45 BST. Details are available on the Zoom Events landing page that you use to navigate to this event. And also, just as a reminder, all presentation and event recordings from each breakout session will be available on gsk.com. So again, thank you very much to all the panelists, and thank you very much to all of you listening into the call. Thank you much, and have a great rest of the day. (Break) PRESENTATION Mick Readey We'll just give it a moment for the attendees to go up. I can see a few people are joining, but in this one, we will have to be prompt. So what I'll do is -- yes. Let's get going. So thank you, everyone, and welcome to this breakout session focused on chronic viral infections. My name is Mick Readey from the Investor Relations team. And today, I'm joined by Chris Corsico, SVP of Development; Lizzie Champion, VP, Vaccines Commercial for Shingrix; James Greenhalgh, SVP, Specialty Care, Commercial; and Tony Wood, our Chief Scientific Officer. Slide 2 looks at our usual safe harbor statement. And the purpose of this session is to give you a chance to ask questions around our -- around some of the exciting work that we're doing specific to chronic viral infections. REFINITIV STREETEVENTS | www.refinitiv.com | Contact Us consent of Refinitiv. 'Refinitiv' and the Refinitiv logo are registered trademarks of Refinitiv and its affiliated companies. JUNE 27, 2023 / 1:00PM, GSK.L - GSK plc Virtual Management Event: Getting Ahead of Infectious Disease At this point, I will hand the presentation over to Chris.