Johnson & Johnson (NYSE:JNJ) Q3 2023 Earnings Call Transcript

John Reed: Yes, to follow up on Joaquin’s comments, we’ve been progressively adding more and more capacity. That’s included at our original launch site in New Jersey, but we’re close to having an additional manufacturing site up and rolling in Europe, in Belgium, and also have recently increased our capacity by using some excess capacity that Novartis had to further bolster the number of slots that we can accommodate. One of the traditionally rate-limiting components of the therapy has been the lentivirus component, and there we’ve made really outstanding progress in-house, mastering that technology, increasing the scale at our factory in Switzerland. And we’re in the process — we’re building, I think it will be available next year, another factory in the Netherlands to support the lentivirus component, which has sometimes been one of the rate limiting aspects.

So altogether the capacity continues to ramp up and we continue to perfect the technology I would say. Same thing with the number of centers that are qualified to administer the therapy and we’re also making progress on the number of countries where CARVYKTI will be available. So very excited, obviously, about the momentum with that. Really, that best-in-class CAR therapy, the CARTITUDE-4 data as you know, showed unprecedented progression-free survival benefit, a hazard ratio of 0.26, overall response rate of 99%, 86% complete response. Very durable for a one and done therapy that was well tolerated. The Grade 3 or above cytokine release syndrome was only 1.1%. So this is really, I think, now emerging as the preferred second line therapy. And we hope to do more such as bringing the front line as a possible alternative to stem cell transplant.

Joaquin Duato: And, you know, Geoff, to your point, in multiple myeloma new product launches, we are also very encouraged by the launch of TECVAYLI and also the recent appointment of TALVEY. The progression of these medicines is exceeding our internal expectations and we already have about 2,000 healthcare professionals in the U.S. that are REM certified to be able to administer TECVAYLI and TALVEY. So very encouraging progress in these two medicines in multiple myeloma. And we expect to be able to break out TECVAYLI sales beginning in 2024.

Operator: Thank you. Next question is coming from Josh Jennings from TD Cowen. Your line is now live.

Josh Jennings: Hi. Good morning. Thanks for taking the questions. I was hoping to ask on STELARA and the biosimilar competition in the U.S. now expected in 2025. That’s not new news, but I wanted to check in on how beneficial is the extra year for the innovative medicine and businesses defense strategy. I guess focusing on just the potential for TREMFYA to take share from STELARA and psoriasis and psoriatic arthritis and inflammatory bowel disease indications? And does this time make sure you provide more confidence and potential to hit the constant currency revenue target set for 2025 for the pharma unit? Thanks.

Joaquin Duato: Thank you for the question. Certainly we have always been very confident in being able to hit our $57 billion target in 2025 for pharma. As I have explained before, there are a number of factors there, the first one and most important is the growth that we’re having in our key assets, TREMFYA, ERLEADA, UPTRAVI, our long-acting injectables, and especially DARZALEX, we continues to have a tremendous trajectory gaining share in first line. We are encouraged, as I just commented, by the launches of CARVYKTI, the progression of SPRAVATO, and also the recent launches too, also in multiple myeloma of TECVAYLI and TALVEY. And looking into 2024, the remainder of the year, and also into 2025, we have some very exciting news in our pipeline.

Some of them have been already commented. For example, the first chemo-free regimen as first line in EGFR mutated non-small lung cancer. We will be presenting the data of MARIPOSA in our ESMO and that potentially will be a filing and an approval in 2025. This would be a new standard of therapy in this line of therapy in this very important need for patients. We also continue to be encouraged by the progress in our TARIS drug delivery platform. You are also going to see data being presented at ESMO. Very important for us in two existing products. We will be presenting data on TREMFYA in IBD, both in Crohn’s and in ulcerative colitis for a potential approval later in 2024, that’s going to be a very significant growth driver for TREMFYA, take into consideration that in the STELARA case, IBD represents 75% of the sales.