But, I think, it’s important to note as well that we’ve talked a lot about the importance of the growth portfolio that we had. We saw nice double-digit growth with that portfolio in the quarter. We actually are now about 40% of the overall business is comprised by that portfolio of products. And remember, this is a diversified portfolio of assets across each of our therapeutic areas. And we feel good about the potential of that portfolio going not only through the end of this year, but to be a catalyst for growth in the back half of the decade. And then we saw very nice progress with the pipeline over the course of the quarter. So, I think, it’s important to recognize that while IRA has an impact in the middle of the decade, we feel very good about being able to more than compensate for that with a very young and attractive growth profile, it’s coming from our growth portfolio and the pipeline.
David?
David Elkins: Yeah. And on — Steve, on your question around Revlimid, just a couple of comments I’ll make on that. One is what I said is that, you know, the free drug program has come down to normal levels. So, no change in, you know, the program there just throughout last year. Those, you know, those levels came down in the start of this year. Remember, every calendar year, it starts again back at, you know, traditional levels. So, that was in relation to that comment. The other thing as it relates to Revlimid is, you know, as we said, there’s no change to our guidance this year as previously said, it was $1.5 billion to $2 billion step-down this year and the same next year. So, for this year, if you remember, we exited last year at $6 billion.
So, it will be in that $4 billion to $4.5 billion is our best view this year and then further step-down next year. So, we’ll be through the LOE of Revlimid, you know, basically at the end of next year. And then, as Chris talked about, you know, we’ll get insight to what’s happening with Eliquis from an IRA perspective when that price becomes public here in September. And recall that the LOE for Eliquis is in 2008. And then lastly, the thing I’d say about, from an LOE perspective as it relates to Opdivo, is, you know, that LOE is in December of 2028. So ’29 is when that LOE would start. And then, three things I’d say about that, as we think about that franchise, one is, we’re looking forward to launching the subcutaneous formulation of that in, you know, early next year and, we believe, that will help that franchise continue into the next decade.
I think you’ve heard Samit talk about Opdualag and that combination. We’re really excited, number one, with its performance and standard-of-care in first-line melanoma, but also with the data that we’re seeing in lung, we’re really excited about continuing that program into Phase 3 and bringing that. And also there’s other tumor types that Opdualag will come in. So, as we think about that franchise, you know, there’s multiple avenues for that franchise to continue into the next decade.
Samit Hirawat: Just adding one thing, Steve, around Revlimid. You know, we had seen some volatility in generic dispensing in the quarter, including some generic supply shortages. And so, you know, Revlimid and our legacy portfolio continues to be a strong source of cash flow for the organization.
Tim Power: Great. Let’s go to the next question, please.
Operator: And our next question today comes from Trung Huynh with UBS. Please go ahead.
Trung Huynh: Hi, guys. Trung Huynh from UBS. Thanks for the question. Two from me, if that’s okay. Just one on the cost-saving program. How is that $1.5 billion split between this year and 2025? There’s no change to your OpEx guide, but, I think, you noted savings were absorbed by the deals. Is 2024 the main year you’ll see most of these costs realized? And then, just on Abecma, you have KarMMa-3 on the label now. You noted it’s going to be important for growth. How quickly can we start to see that helping? Is it realistic to see an inflection immediately? Thanks very much.
Chris Boerner: Thanks for the question, Trung. David, then Adam.
David Elkins: Yeah, the vast majority of the savings comes through this year because if you think through the actions that we’re taking, whether it’s, you know, positions, the portfolio actions, we made those actions immediately and the third-party spend, we’ll receive that. And then, you have it annualized fully next year. So, that’s really the difference between ’24 and ’25. But it’s safe to say that most of, all the actions we’re taking, 90% of those are being done this quarter.
Adam Lenkowsky: Yeah. Trung, as it relates to Abecma, we’re certainly pleased with the regulatory approvals of KarMMa-3 in the triple-class exposed setting in the US, in Europe and in Japan. You know, this will remain a very competitive space with multiple products and modalities available. Our focus is on educating physicians on the KarMMa-3 data, Abecma’s differentiated and predictable safety profile as well as the manufacturing reliability that we’ve had with Abecma. We’re also focused on expanding our site footprint in the US and around the globe, making Abecma available to more patients. So we believe that there is a place for multiple assets in this market and our objective is to return Abecma to growth over time as we move into a larger patient population.
Tim Power: Let’s go to the next question, please.
Operator: Our next question comes from Matthew Phipps with William Blair. Please go ahead.
Matthew Phipps: Hi. Thanks for taking my questions. Adam, I was wondering if you can comment on, is there any path to grow Opdualag in melanoma outside the United States or will additional data be needed? And then, maybe for Samit, on KRYSTAL-12, I don’t suppose you can give us any tidbits on trends and overall survival at this point. I know the study is ongoing there, but maybe, if not just confidence in that dataset as it stands today being able to support full approval?
Adam Lenkowsky: Yeah. I’ll start. Thanks for the question. First, I’d say we’re pleased with our continued progress as Opdualag has become the standard-of-care in the United States in first-line metastatic melanoma. We saw over 70% growth versus prior year and our market share now is above 25% in the US, and we still have further room to grow, penetrating what’s still around 15% monotherapy use. It’s exciting because we’re also starting to launch internationally in markets like Australia, in Canada, in Brazil, as well as several European markets. We still have not had an opportunity to launch in Germany, but, you know, we are working on that negotiation and we’re hopeful that we have an opportunity to launch there sometime in the back end of this year and into next year.
Additionally, as spoken earlier, we’re very pleased to have the proof-of-concept study with LAG-3 on-top of PD-L1s and chemo in first-line lung cancer. And, you know, when you add that up, coupled with opportunities with lung and adjuvant melanoma, Opdualag truly has the potential to meaningfully extend our IO franchise well into the next decade.
Samit Hirawat: Yeah, and thank you for the question. If I think about KRYSTAL-12, remember, this is a study with a primary endpoint of progression-free survival and you will see the data being presented at ASCO. Overall survival data remains immature at this time, so I will not be able to comment on the specifics of that, but really excited for the confirmation of the single-arm study previously done now with the randomized study over here.
Tim Power: Thanks, Samit. Let’s go to the next question, please.
Operator: Our next question comes from Olivia Brayer with Cantor Fitzgerald. Please go ahead.
Olivia Brayer: Hey. Good morning, guys, and thank you for the question. What does the commercial roll-out strategy look like for KarXT as we look past that September PDUFA and any thoughts around Medicaid negotiations? And then when do you think we start to see some meaningful growth from that franchise, whether that’s next year or more so in 2026? Thank you.
Chris Boerner: Adam?
Adam Lenkowsky: Yeah. Thanks for the question. So, we’re very excited about the opportunity to launch KarXT later this year. This is a very important drug with significant commercial potential. As we talked about, KarXT will be the first innovative therapy in schizophrenia approved for decades. And what we’ve shared is KarXT offers Zyprexa-like efficacy without the significant adverse events that’s plagued the D2 such as, you know, weight gain, dyslipidemia, EPS. And we know how compelling this is for physicians. We are rapidly preparing for the launch and the plans are going well, and we will be ready to launch by the summer well in advance of our PDUFA date. We’ve been focused on pre-launch efforts and made very good progress preparing for the launch.
So, Karuna had made good progress in sourcing a very experienced commercial organization and our field medical and our access teams have already begun meaningful conversations with thought leaders and payers. Our pre-launch efforts today are focused on driving awareness of this new mechanism. We’re currently building out a large neuroscience field sales organization. In fact, we’ve increased the investment across multiple fronts to maximize the opportunity that we have. So, we also, you know, need to ensure that physicians have a positive first experience. So, we’re focused on building our customer model to make sure that we have the optimal physician caregiver and patient support. And as you alluded to, we know that achieving rapid access is important.
And so, this is a largely Medicaid and Medicare opportunity around 70% and our access teams are ready today. You know, we will leverage our large access organization to ensure rapid access for patients. Our teams have already been out meeting with state Medicaid directors and the feedback on the product profile has been very, very positive. So, over half of state Medicaid programs either have no step-edits or a single step-edit. So, our goal is to improve the quality of access to only one step-edit, which we know is going to take some time, but we’re very confident in our ability to achieve quality access for this product. So, given a September ’26 PDUFA and some of the timelines to attain broad Medicaid coverage, we effectively see this as a 2025 launch.
But we’re very excited about the potential of KarXT and we plan to make this a very big product for Bristol Myers Squibb.
Tim Power: Thanks, Adam. We’re starting to run a little short in time, maybe take two or three more. Can we go to the next one?
Operator: Our next question comes from James Shin with Deutsche Bank. Please go ahead.
James Shin: Hey. Good morning, guys. Thanks for taking my question. I had a question on Opdualag Phase 2 for front-line non-small cell lung. I know full dataset is set for readout in the second half, but can you share if what you’ve seen is any different or comparable to the other LAG-3 non-small cell datasets such as TACD?
Samit Hirawat: Certainly, I can take that question. Look, the — obviously can’t comment on what others have seen. All we know is they’ve seen six patients worth of data. Hard to compare six patients worth of data with more than 200 patients treated with Opdualag plus chemotherapy in the first-line setting. What we have seen is overall review of our own dataset, looking at the various endpoints that we looked at as well as the biomarkers we looked at in our trial and we remain confident in the profile of the drug to take it forward into the Phase 3.
