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

Please turn to Slide 18. Finally, our General Medicines portfolio continues to contribute more than £2 billion in the quarter, led by Trelegy, which was up 23%. Trelegy is the fastest-growing triple therapy for COPD and asthma with room to grow as the SITT class still only has 28% penetration of the COPD patient class share in the US. Overall, General Medicines were down 2% for the quarter due to negative RAR impact, slightly offset by Trelegy demand and continued post-pandemic recovery of the EU and international antibiotic market. Taking everything into account, we now anticipate low- to mid-single-digit growth this year. And with that, I’ll now hand over to Deborah to cover HIV.

Deborah Waterhouse: Thank you, Luke. Our HIV business delivered sales of £1.6 billion in the third quarter, growing 15%. This growth was primarily driven by patient demand, which contributed 10 percentage points of growth, with the majority of the remaining 5 points from tender phasing in our international business. Our continued strong performance through this quarter means we are now increasing our guidance for full year growth to around 10%. Our performance benefited from strong patient demand for our oral two-drug regimens and long-acting injectable medicines, which are now 53% of our total portfolio value. Dovato delivered £477 million in the quarter. Market performance reflects HCP belief in Dovato, which has firmly consolidated its position as the leading oral two-drug regimen.

I’d like to spend a few moments describing our expectations around Dolutegravir’s loss of exclusivity. In Europe, the composition-of-matter patent expires in July 2029. In the US, Dolutegravir is protected by a composition-of-matter patents until April 2028, which includes an additional six months of exclusivity, following the completion of our pediatric studies. Dovato and Juluca are also protected by formulation and other patents in the US, which have expiry date after the composition-of-matter patents. Therefore, we anticipate a longer exclusivity period in the US with Dovato until December 2029 and Juluca until July 2030. Moving to our long-acting injectable portfolio. Cabenuva sales for the quarter were £182 million, reflecting strong patient demand with high levels of market access and reimbursements across the US and Europe.

Cabenuva continues to be supported by strong label evolution and data, which underpins confidence. Patient awareness of Cabenuva is high at over 70% and around two-thirds of switches are coming from competitor products. Moving on to prevention. Sales of Apretude, the world’s first long-acting injectable for the prevention of HIV, delivered £37 million in the quarter, and we are pleased by the momentum across the US. This, alongside the desire by prescribers, payers and governments for new solution to help end the HIV epidemic, gives confidence that the PrEP market in the US will continue to grow strongly. We were also pleased to receive European approval for Apretude in September. We’re also pleased by the progress of our pipeline, which is focused on innovative long-acting regimens.

We have three clear target medicine profiles to provide the world’s first self-administered long-acting regimen for treatment, and to provide ultra long-acting regimens for treatments and prevention. In our recent HIV Meet the Management event, we confirmed that we are currently on track to deliver an every four-month injectable regimen. This would enable us to double the dosing interval, enabling clinic visits to be halved to just three per year, meaningfully increasing the benefit of long-acting regimens for patients and healthcare systems. The four-monthly dosing and prevention, we said we currently expect approval in the 2026 timeframe, and for four monthly treatments in 2027. We also provided greater clarity on our roadmap to further extend the dosing interval of our long-acting regimens in treatment and prevention to enable every six month dosing towards the end of the decade.

To conclude, we remain very confident in our ambition to achieve a five year sales CAGR to 2026 of 6% to 8% and to maintain our innovation leadership in HIV. This, combined with the continued growth of the long-acting market, gives us the potential to significantly replace the revenue from the Dolutegravir loss of exclusivity. I will now hand over to Julie.

Julie Brown: Thank you, Deborah, and good afternoon, everyone. As you’ve heard from the team, we’ve made great progress on our roadmap since the second quarter results and we’re well-positioned heading into the end of the year. We continue to be focused on execution, our pipeline, capital allocation and investor engagement. And as Tony mentioned, we’ve had several regulatory approvals, including Ojjaara and Jemperli during the third quarter. And following our HIV Meet the Management event in September, we look forward to holding a similar event focused on respiratory on the 30th of November. Please now turn to Slide 22. Turning to the quarter, as I cover the financials, references to growth are at constant exchange rates, and I’ll focus my comments on adjusted results.

So, starting with the income statement. Sales increased 16% excluding COVID solutions and were up 10% overall, reflecting continued strong execution with the extremely successful launch of Arexvy. Gross margin improved 80 basis points, excluding COVID and 360 basis points at CER, including the impact of lower sales of Xevudy. SG&A growth was 14% excluding COVID. And as a reminder, in Q3 last year, we have foreign exchange gains on the Vir collaboration, which contributed 3 points to reported SG&A growth this quarter due to the credit last year. Adjusted operating profit grew 22% excluding COVID solutions and 15% overall. The margin increased to 34%, driven largely by cost of goods improvements and operating leverage. Turning to the reported results.

Total operating profit increased 83% to £1.9 billion, and this was driven by overall performance as well as favorable CCL movements and fair value gains from our stake in Haleon. The reconciliation of total to adjusted results is included in the appendix. On currency, there was an adverse 6 point impact on sales and 9 points on adjusted operating profit, primarily due to the strengthening of sterling against the US dollar. Please now turn to Slide 23. Moving to the adjusted operating margin dynamics in the quarter. The margin increased to 170 basis points to 35% at CER and improved 180 basis points, excluding COVID solutions. Overall, cost of goods has been favorable, primarily reflecting reduced sales of lower-margin Xevudy and an improvement in mix towards Specialty and Vaccines.

Regarding SG&A, we are in an investment cycle, supporting our priority products. Our spend is focused on maximizing the launch of Arexvy, building awareness of RSV, and catalyzing the global market expansion opportunity for Shingrix. We now have approval in 39 countries for Shingrix and 18 countries for Arexvy. Specialty Medicines is also a targeted investment area, with clear opportunities for the long-acting HIV franchise and the launch of Ojjaara in oncology. We confirm our guidance for SG&A this year with the growth broadly in-line with sales. It is important to say that following a period of investment, we now expect to move to a period of delivering returns on that investment and building on the great foundation of performance. In this new cycle, SG&A growth will step down and will be accretive to profits in 2024.

Next slide, please. Adjusted earnings per share grew 17% overall and benefited from lower net finance expense following debt restructuring and the favorable tax rate, partly offset by higher ViiV profits, leading to an increase in non-controlling interests. Next slide, please. Cash generated from operations was £4.4 billion in the year-to-date and £1.4 billion lower than the prior year. There are two major items to call out: firstly, the receipt of the Gilead settlement last year of £0.9 billion; and secondly, the increase in working capital, influenced by stronger Arexvy sales in Q3 and lower Xevudy collections. The Arexvy sales will come through in the fourth quarter cash flow. Free cash flow more than doubled to £1.7 billion in the third quarter and brought the nine month year-to-date to an inflow of £1.3 billion.