Earnings Call Transcript - BMY Q1 2024

Timothy Power, Vice President and Head of Investor Relations

Thank you, and good morning, everyone. Thanks for joining us this morning for our first quarter 2024 earnings call. Joining me this morning with prepared remarks are Chris Boerner, our Board Chair and Chief Executive Officer; and David Elkins, our Chief Financial Officer. Also participating in today's call are Adam Lenkowsky, our Chief Commercialization Officer; and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Development. As you'll note, we've posted slides to bms.com that you can use to follow along with for Chris and David's remarks. Before we get started, I'll read our forward-looking statement. During this call, we'll make statements about the company's future plans and prospects that constitute forward-looking statements. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those discussed in the company's SEC filings. These forward-looking statements represent our estimates as of today and should not be relied upon as representing our estimates as of any future date. We specifically disclaim any obligation to update forward-looking statements even if our estimates change. We'll also focus our comments on our non-GAAP financial measures, which are adjusted to exclude certain specified items. Reconciliations of certain non-GAAP financial measures to the most comparable GAAP measures are available at bms.com. And with that, I'll hand it over to Chris.

Christopher Boerner, CEO

Thank you, Tim, and good morning, everyone. Q1 was a busy quarter for us and a good start to 2024. Starting on Slide 4, and knowing what an active quarter we had, I wanted to start by telling you how we think about our performance across four dimensions. First, the performance of our commercial portfolio was good and broadly in line with our expectations, even with some products impacted by inventory or gross to nets. Second, we made solid progress advancing our pipeline. Third, we closed four import transactions that strengthened our long-term growth profile during Q1. And fourth, we're taking decisive actions to improve productivity. Taken together, Q1 performance was broadly aligned to our internal expectations. And importantly, there is no change to the underlying business outlook we provided in February. As you know, we've included the accounting impact of the recently closed transactions in our non-GAAP EPS guidance. Let's turn to Slide 5 for some details. I'll start with some highlights on commercial performance. We've seen real strength across key brands, including Eliquis, Opdualag, Reblozyl, Yervoy, and Breyanzi. And though the BCMA space remains competitive, our objective is to return Abecma to growth over time with the KarMMa-3 approval as we move into a larger patient population. Turning to Opdivo, Camzyos, and SOTYKTU. What's important about all three brands is that demand grew while revenue was impacted by other factors such as inventory and gross to nets. Today, we are seeing the inventory patterns for Opdivo and Camzyos normalizing. And for SOTYKTU, we're steadily building commercial script volume as access continues to improve this year. David will give you more details, but taken together, the commercial performance in Q1 is in line with our expectations and sets us up for the year. Second, we made important progress advancing our pipeline. This includes two important cell therapy approvals, the initiation of new registration trials, and important proof-of-concept data for Opdualag in lung cancer from a pre-specified analysis of our Phase II during Q1. We're looking forward to starting a Phase III registrational trial versus standard of care in a segment consisting of about 20% to 30% of non-small cell lung cancer patients.

David Elkins, CFO

Thank you, Chris, and good morning, everyone. As Chris highlighted, we're off to a good start to the year with top line growth as shown on Slide 10. As a reminder, unless otherwise stated, all comparisons are made from the same period in 2023 and sales growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange. Building our momentum coming out of last year, we're executing against our plan to drive our growth portfolio, which delivered approximately 11% sales increase in the first quarter compared to the prior year and now represents approximately 40% of our total revenue. This growth was broad-based, with most growth brands recording significant increases in the quarter. Our legacy portfolio also contributed to overall sales growth in the quarter, with strong sales of Eliquis, which remains an important cash flow generator for the company. Now turning to the first quarter performance of our key brands, and starting with oncology on Slide 11. On this slide, you can see the impact of our strategy and broadening our I-O franchise and expanding in new targeted solid tumor therapies. Global sales of Opdivo were impacted by inventory work down and timing of orders in the U.S., partially offset by demand growth. As we said in the past, we expect to see growth at a more modest pace than 2024.

Geoffrey Meacham, Analyst

Just had one for Chris or maybe for David. On the cost savings, how much would you say was legacy Bristol, either workforce or facilities versus optimizing integration of all your recent deals? I guess I'm trying to get a sense for whether you think there's further optimization to come as you guys focus on the new launch portfolio.

David Elkins, CFO

Yes. Thanks, Jeff, for the question. The majority of the savings come from the historical BMS. As we talked about, the main drivers of the $1.5 billion savings really came into three buckets. First was really looking at the portfolio, obviously, with the Mirati, Karuna, and RayzeBio, we have really important portfolios that we're bringing into the overall portfolio. That gave us the opportunity to look at that and maximize the ROI of the totality of the portfolio as well as adjusting for some updates on new data and the competitiveness. The second thing that we really looked at for legacy BMS is how do we become more agile, quicker decision-making, and streamline the organization by removing layers of management so decisions can be made more quickly. And there, we talked about the roughly 2,200 impacted employees as a result of those changes. And then lastly, we went through all of our third-party relationships, continuing to look for efficiencies in third-party service providers, and that was the last category. And a lot of those activities are also legacy BMS. So the vast majority of the savings are coming from our in-house existing operations.

Christopher Boerner, CEO

Thanks, Chris. Let me just say a couple of words and then I'll turn it over to David for the first part of your question, then Adam can come in on the back end. First, as David mentioned, when we thought about these efficiencies, we were really thinking along three lines: the need to invest in the pipeline; ensuring that we had adequate investment for our growth products; and then needing to be more agile and focused as an organization. In terms of how we think about allocating those redeployment opportunities, I would say, generally speaking, they're in that order with the majority going back into R&D.

David Elkins, CFO

Thank you for your question, Chris. To clarify, roughly two-thirds of the savings are attributed to R&D, while about one-third comes from MS&A. It’s also important to consider our recent acquisitions, particularly Mirati and Krazati, which are crucial for our development programs in first-line lung cancer, covering both the doublet and triplet therapies. Additionally, with Karuna, there are several significant opportunities in this area. We previously discussed schizophrenia and are also expanding into Alzheimer’s, particularly with agitation and psychosis. Therefore, these areas require substantial investments.

Samit Hirawat, Chief Medical Officer

Thank you, David. Building on what he mentioned, we took a careful approach to evaluate our pipeline and identify assets we would not pursue further. We analyzed the evolving science behind our clinical assets. For instance, regarding our development of CTLA-4, we established a high benchmark with ipilimumab. Upon reviewing the data, we determined that if it wasn't going to outperform ipilimumab, there was no reason to continue the program, so we chose not to proceed with it. Similarly, our assessment of the SIRP alpha program, based on both external and internal data, indicated that it did not meet our standards. We also considered the potential return on investment for patients and decided not to carry on with that program. Additionally, we evaluated whether a program, despite having strong scientific data, would make sense for our company’s size and growth goals. In the case of BET 158, while the data in myelofibrosis may be promising, it does not meet our criteria for being a significant driver of growth, so we will not continue with that program.

Adam Lenkowsky, Chief Commercialization Officer

Yes. Chris, thanks for the question. So we're making good progress across the totality of our growth portfolio. As David shared, we saw strong year-on-year demand growth across the majority of our growth products. And we continue to be focused on accelerating our key brands. And we're doing what we said we would do as we continue to drive our growth portfolio. So just a few of the products that I think is important to mention. Opdualag has become a new standard of care in first-line metastatic melanoma, grew 76%. Reblozyl continues to deliver strong performance post-first-line. COMMANDS approval grew over 70% as well. We have increased investment at the end of last year behind products like SOTYKTU, Breyanzi, and Camzyos. Camzyos continues to demonstrate strong growth. We had 25% growth of new patients added onto commercial drugs quarter-over-quarter. Breyanzi, we also increased our investment. We're in a much stronger supply position today than we were last year and increasingly being recognized as a best-in-class CAR-T. And as David mentioned, we're readying for the launch of KarXT in September, which is a very significant multibillion-dollar opportunity.

Timothy Power, Vice President and Head of Investor Relations

Thanks, David. Can we go to the first question, please?

Operator, Operator

Our first question comes from Geoff Meacham with Bank of America.

Christopher Boerner, CEO

Yes. Thanks for the question, Seamus. Maybe I'll start, have Adam weigh in a little bit more on IRA. With respect to the ongoing discussions with CMS, we're not going to be commenting. As I said earlier, we will have the outcome of that public in September and we'll be able to provide more insight at that point. But Adam, you can speak to some of the other aspects of IRA and then Samit.

Adam Lenkowsky, Chief Commercialization Officer

Thank you, Chris and Seamus, for the question. Regarding the IRA, there are several components to consider, including negotiations and changes to the Part D benefit design. For 2024, we do not expect a significant impact across our portfolio, including Eliquis, Revlimid, and other brands. However, we anticipate more substantial changes to the Part D benefit next year due to the redesign affecting these products. We are currently evaluating the individual dynamics of each product and will monitor the situation closely to gauge the impact of new measures, such as out-of-pocket caps and other system changes. For instance, as we move from a $3,500 cap to a $2,000 cap, we expect more patients to fill their prescriptions successfully as costs at the pharmacy decrease. Nonetheless, we will need more data before providing additional details.

Samit Hirawat, Chief Medical Officer

Thank you, Adam. And then thanks, Seamus, for the question. For Opdualag, let's just take a step back and understand what we were planning to do and try to do. So for Opdualag, we conducted a study of Opdualag plus chemotherapy in first-line non-small cell lung cancer. At first, we wanted to define the dose. So we tested a couple of doses in the first part of the study. And in the second part of the study, we then randomized the patient to receive Opdualag plus chemotherapy versus nivolumab plus chemotherapy. And as we have said before, what we wanted to understand, is the drug applicable for all patients? Or are we going to find a differential activity in a subset of patients? And what we have said is we have found a subgroup of patients where the drug's activity is good and encourages us to now go into a Phase III trial. And so we are looking forward to presenting the data in the second half of this year as well as initiating the trial versus standard of care in the second half of this year.

Timothy Power, Vice President and Head of Investor Relations

Thanks, Adam. We're starting to run a little short on time, maybe take 2 or 3 more. Can we go to the next one?

Operator, Operator

Our next question comes from James Shin with Deutsche Bank.

Samit Hirawat, Chief Medical Officer

Certainly, I can take that question. Look, obviously, I 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 data set, looking at the various endpoints that we looked at as well as the biomarkers we looked at in our profile and we remain confident in the profile of the drug to take it forward into the Phase III.

Christopher Boerner, CEO

Well, let me start and then I'll ask Samit and Adam to speak. Let me just at a high level, though, say that we continue to be incredibly excited about radiopharmaceuticals as a platform. It's one of the fastest-growing platform in solid tumor oncology. We believe we have a best-in-class asset that we've acquired with Rayze. The integration of that team has gone very well. We continue to be very excited and happy with the bringing online of the facility in Indianapolis. So in terms of us getting that asset, incredible enthusiasm and the integration has gone well. But Samit, maybe you and Adam can speak to details.

Adam Lenkowsky, Chief Commercialization Officer

I will add a few points. RayzeBio was a significant strategic acquisition that we believe helps diversify our oncology portfolio. As Chris mentioned, we expect this modality to continue growing over time. It will be competitive, but what we find appealing about RayzeBio is its potential as an IND engine. The lead program, RYZ101, is already in Phase III development for GEP-NET, as mentioned earlier. We also see opportunities in small cell lung cancer, breast cancer, and potentially other tumor types. This acquisition is highly complementary to our existing portfolio.

Timothy Power, Vice President and Head of Investor Relations

And maybe we could go to our last question, if you don't mind, Rocco?

Operator, Operator

Our final question comes from Akash Tewari with Jefferies.