GSK plc (NYSE:GSK) Q3 2023 Earnings Call Transcript

We expect to publish these data in a peer-reviewed scientific journal before the end of the year. Slide 11, please. Continuing with infectious diseases, bepirovirsen, our triple-action antisense oligonucleotide, has the potential to be the cornerstone of functional cure for patients with chronic hepatitis B. It inhibits viral replication, reducing viral DNA, and thus the production of viral proteins including hepatitis B surface antigen. And importantly, it stimulates the body’s innate immune system. We believe this triple mechanism-of-action is the reason for bepi’s unique profile. There are more than 300 million people living with hepatitis B and our goal is to provide patients with the first clinically meaningful functional cure for hepatitis B, eliminating the need for continued therapy and ultimately reducing the long-term risk of developing liver cirrhosis and cancer.

We now have two completed Phase II trials, for which data are consistent and demonstrate that patients with low surface antigen have the greatest chance of a functional cure when treated with bepi. In the case of B-Together, this is not significantly improved by sequential Peg-interferon treatment. However, the recent exclusive license of Janssen’s Phase II small interfering RNA-based therapeutic provides a complementary opportunity to develop a potential novel sequential regimen to benefit a broader patient population and potentially drive higher functional cure rates. Lastly, we hope data from B-Sure will be presented later this month at AASLD. This will demonstrate a durable response for a significant proportion of patients treated with bepi.

Our Phase III trials B-Well 1 and B-Well 2 are progressing as planned in 31 countries with data anticipated in 2025. Turning to my final slide. This slide highlights important clinical data readouts and regulatory events over the upcoming months. You can find a comprehensive overview in the appendix. In summary, I’m pleased with our progress so far this year. We have clear plans to move forward at pace, deliver on our key objectives for R&D and support GSK’s overall growth ambitions. I’ll now hand it over to Luke on Slide 13.

Luke Miels: Thanks, Tony. In Q3, we again delivered growth across Vaccines and Specialty Medicines in each region with £8.1 billion of sales, up 16% versus last year, excluding pandemic solutions. Please turn to Slide 15. In Vaccines, we saw strong growth of 34% in the quarter excluding pandemic solutions, led by the excellent launch of Arexvy, which contributed £709 million. On the same basis, we now expect full year Vaccines sales growth to be around 20%. On Arexvy, I want to highlight the excitement our organization has had behind the launch that we’ve seen in the US. Following an initial inventory build, we saw high demand and received two out of every three retail prescriptions. In the quarter, we saw around 50% of Arexvy doses were co-administered with flu.

And we’re pleased with our commercial positioning in all major pharmacies, including competitive contracts with 11 key accounts. We strategically chose to highlight our 94.6% efficacy in the co-morbid population and that message seems to resonate well with strong HCP brand recognition. There’s a long runway for Arexvy in the US, where during the quarter, we vaccinated more than 1.4 million adults of the 83 million at-risk, and ex-US, as launches are underway across Europe and Canada. In September, we also received approval in Japan. We remain confident in our peak sales being greater than £3 billion. For the full year, we expect sales to be between £0.9 billion and £1 billion, based on an analogue of flu vaccination seasonality. However, there continue to be unknown factors including annual vaccination patents, duration of protection and what re-vaccination recommendations might be.

We will continue to keep you informed of course as we learn more. Next slide, please. Moving to Shingrix, this remains an important vaccine for our portfolio, up 15% versus last year with the ex-US contribution now representing 50% of sales. In addition to the US, Shingrix is available in 38 additional countries, with less than 3% penetration in most markets, and we continue to have unconstrained supply. In the US, we have reached the most motivated consumers with 33% penetration of more than 120 million adults recommended to receive Shingrix. We remain encouraged by the growth in retail, which was up 4% in the quarter and are investing in strategic initiatives to actively target consumers and HCPs to access the next tranche of customers. In October, we announced the deal with Zhifei to co-promote Shingrix in China, and this partnership materially expands the number of Chinese adults who can benefit from Shingrix over the next three years through a company with a track record of driving access to innovative medicines and vaccines in China.

Zhifei has a significant reach across China with an extensive service network covering more than 30,000 point of vaccination versus the current 9,500 we have now. As Emma mentioned, we expect this partnership to support and accelerate our expectations for Shingrix sales to reach more than £4 billion by 2026. Next slide, please. In Specialty Medicines, including HIV, which Deborah will cover shortly, we’ve increased our sales by 17% excluding Xevudy. For the full year, we now expect low-double-digit sales growth. Our market-leading medicines Benlysta and Nucala continue to deliver double-digit growth. Benlysta was up 20% in the quarter, with growth across all major markets and a promising opportunity with updated EULAR guidelines now recommending use earlier as part of a standard-of-care for lupus and lupus nephritis.

Nucala was up 19% in the quarter and remains the first and only biologic approved in four eosinophilic diseases. We expect to see COPD data for Nucala in the second half of next year. Both of these medicines continue to have room to grow with relatively low buyer penetration and lifecycle opportunities, underscoring our confidence in the long-term opportunity for both. In oncology, sales were up 26% in the quarter with Jemperli now being used in the first-line for appropriate endometrial cancer patients, and Zejula was up 22% due to stocking of our new tablet formulation, providing an improved patient experience. We expect this stock will be utilized by the end of the year. And on this slide, I wanted to highlight the recent approval of our myelofibrosis medicine Ojjaara.

In addition to a line-agnostic label in the US, regulators acknowledged our unique benefit in anemia, an especially important characteristic for these patients as we know that anemia status from requirements of transfusion directly correlate with poor survival prognosis and quality-of-life. And as you can see on this chart, if you’re a myelofibrosis patient with no anemia, you have a median eight-year life expectancy. Conversely, you have a two-year life expectancy, if you’re severely anemic. So, for example, your hemoglobin level is below eight. We look forward to making this medicine available to patients and have already recorded sales in September. And when these updates, we are raising our full year oncology sales expectations to increase to low-single digit.