And you see that quarter-over-quarter because we are making sure that we’re able to provide access to patients who deserve and are eligible for [indiscernible].
Operator: Next we have Mohit Bansal with Wells Fargo.
Mohit Bansal: And I have a question regarding your S1P etrasimod. Would love to get your thoughts on the labels. It seems like you could avoid a lot of cardiac monitoring, but at the same time there is this new requirement of eye exam as well as skin exam. How do you think about uptake, considering these examinations before the start of the treatment, given that these doctors are not used to it?
Mikael Dolsten: I’m happy to start on it. I think we have a very robust label for etrasimod. It’s the only S1P in this drug class [indiscernible] that have a simple flat dosing and immediate start without any prior need for, let’s say, cardiac rhythm exams, like the other prog in this class. All S1P have various eye exams to monitor. And I think our label similarly has a recommendation to do that. So it’s really nothing new. And our efficacy data, and you see, has been very favorable. So we are very optimistic that this can be a true best-in-class ulcerative colitis.
Angela Hwang: I was just going to add to that that, competitively, we believe that we have an excellent efficacy and safety profile. We don’t have a need to titrate up, as Mikael said. And also, our assessment of standard versus our competitors at the initiation of therapy. So I think that this is a level playing field that we’re in. Certainly patient support is an area of focus for us, right, to ensure that patients are getting the assessments that they need. But we feel that we’re – this is pretty standard practice and we’ll be able to launch this product as planned.
Operator: Next, we have Geoff Meacham with Bank of America.
Geoff Meacham: Just have a couple of quick ones. First, I know Seagen obviously hasn’t closed yet. But there’s all the emphasis on the ADCs from ESMO. Does it affect how you guys prioritize the pipeline or maybe investments you could make today commercially? And the second question on danu, Mikael, I know a lot has been asked on the upcoming data, but from a commercial perspective, like where do you see the bigger opportunities for differentiation and metabolic? Is it really just oral administration in obesity? Or do you guys look more aggressively at related indications like cardio, renal, et cetera.
Albert Bourla: Chris, do you want to take a question about the Seagen and the pipeline?
Chris Boshoff: Obviously, we remain very confident that we will close Seagen towards the end of this year, beginning next year. As you pointed out, there’s a significant interest now in ADCs because of the potential that they could replace most of the chemotherapeutics in the future for most cancer types. Seagen obviously has a significant track record with both the current approved ADCs from the laboratories and, as you’ve seen, three potential registration phase trials just read out and passed up to Kaiser [indiscernible] but also with the small molecule to Kaiser. They recently started two Phase 3 studies, one with tisotumab vedotin in combination with pembrolizumab in advanced metastatic, HER2 positive or HER2 low bladder cancer.
This is a program that we’re very excited about. Already tisotumab received previously breakthrough therapeutic innovation in the US. And they’re also just about to start another Phase 3 program in non-small cell lung cancer with the B6A integrin beta-6 antibodies. So we remain very confident in their portfolio and the depth of expertise they’re bringing to the development and discovery of ADCs.
Mikael Dolsten: I think you asked about how could a new oral GLP in obesity be positioned for maximal attractiveness and using danu as one example, pending, of course, our excitement to see the data. Well, clearly, as obesity and Type 2 diabetes with overweight are moving from being treated from an endocrinologist and metabolic physicians increasingly now to primary care, particularly with the impressive effects of this drug class on obesity and bodyweight. Oral agents in general are preferred. So I think, once a day drugs such as the new reformulated potential danuglipron would have an interesting role there. I think there is also a growing discussion among opinion leaders in the field that the patients regain weight when they stop the injectable.
And in general, they are only available for maybe a year. So an oral agent that could be taken for a longer period could also play a really interesting role to maintain body weight at a low level. And finally, you’re absolute right, the new data for this drug class suggests that patients could benefit from both cardiac and renal protection. And oral agents allow you to build combination with drugs that already are used in this population, such as the 52, to protect the heart etc. So I think that’s why there is such a big interest in drugs in this class.
Operator: Next, we have Tim Anderson with Wolfe Research.
Tim Anderson: I have a couple of questions on danuglipron. Early dataset showed a QTc signal. Do you think that was a red herring that won’t show up in later data? To me, when I just think about drug classes and seeing QTc signals, seems like it often persists in later datasets. Second question on mRNA flu. You mentioned that safety is the same as licensed vaccines. Does that mean tolerability was as well? I usually think of safety and tolerability as technically being different from each other.
Albert Bourla: Mikael, both questions for you. QTc for danu and tolerability of flu vaccines?
Mikael Dolsten: We have, I think, more than 1,400 patients on danuglipron and it’s a very safe drug. It’s a very safe drug. And we look forward to the readout on efficacy, as we have said. before year-end. So that’s very straightforward. mRNA flu, you had a very good comment, particularly in initial studies, tolerability is really what we focus on. And tolerability was similar to standard of care available vaccines, or the other mRNA vaccines experienced from Pfizer. And we haven’t really had any concerns about safety. So on both tolerability and safety, the statement stands that it looks like previous versions of our vaccines.
Operator: Next, we have Chris Shibutani with Goldman Sachs.
Chris Shibutani: Two questions, if I may. On the cost savings program, you’ve been outlining what the plan is for 2024. But if we look at the pattern of the spending for R&D and SI&A, in the quarter you just reported, I would observe that the magnitude of reduction in the R&D spend was greater than expected relative to SI&A, how should we be interpreting this numbers or anything to read across in terms of the relative amount of cost reductions coming from SI&A versus R&D on the forward? And then a question on ABRYSVO. First quarter sales were solid. Can you just elaborate how much may have been attributable to, for instance, inventory stocking versus actual demand? And if we look at prescription data, looks like from the retail setting, there was about a 30% market share. Is this similar to what you’re observing in the broader market? And how is this conferring with your expectations?
Mark Southey: Let me ask David to answer the question about the R&D and SI&A expenses. And then Angela will take ABRYSVO.
