Yahoo Finance Bristol-Myers Squibb Company (NYSE:BMY) Q1 2024 Earnings Call Transcript
Bristol-Myers Squibb Company (NYSE:BMY) Q1 2024 Earnings Call Transcript April 25, 2024
Bristol-Myers Squibb Company beats earnings expectations. Reported EPS is $-4.4, expectations were $-4.55. Bristol-Myers Squibb Company isn’t one of the 30 most popular stocks among hedge funds at the end of the third quarter (see the details here).
Operator: Welcome to the Bristol-Myers Squibb First Quarter 2024 Earnings Conference Call. All participants will be in listen-only mode. [Operator Instructions] After today's presentation, there will be an opportunity to ask questions. [Operator Instructions] Please note today's event is being recorded. I would now like to turn the conference over to Tim Power, Vice President and Head of Investor Relations. Please go ahead.
Tim Power: 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.
Chris Boerner: 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 important transactions that strengthen 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 are 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 expectation 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 registrational trials and important proof-of-concept data for Opdualag in lung cancer from a pre-specified analysis of our Phase 2 during Q1. We're looking forward to starting a Phase 3 registrational trial versus standard-of-care in a segment consisting of about 20% to 30% of non-small-cell lung cancer patients.
And not on the slide, but important for patients is Milvexian, which has the potential to be the only oral Factor XIa medicine in AFib and ACS. The trials are continuing following the most recent DSMB review with enrollment accelerating. Third, we closed four important deals during the quarter. Across all four, we have added assets, capabilities and expertise that strengthen our ability to drive long-term growth as we exit the 2020s. Our team is driving performance of Krazati. The Rayze radioligand plant in Indiana is now operational. We're in the process of filing an application to supply clinical product for RYZ101 from the site. SystImmune's first-in-class bispecific ADC is advancing into global clinical trials in tumors including lung and over time breast cancer.
And we are very excited about the potential of KarXT from Karuna, which I will review on Slide 6. The team is on track and focused on two objectives. First, launch preparations are underway and on track for KarXT. Second, we are executing against a robust clinical program for this important asset. On this slide, you can see the significant unmet need in schizophrenia and highlights of data recently presented for KarXT. These data demonstrate its compelling long-term efficacy as KarXT was associated with significant improvements in symptoms of schizophrenia across all efficacy measures without evidence of metabolic or movement disorder side effects. This reinforces the very attractive profile for this medicine as an important advancement for patients and a significant commercial opportunity for the company.
Underpinning our efforts to navigate this decade is an enhanced focus on driving operational productivity and efficiency and we have made some notable progress already this year. Let's go to Slide 7. At a company level, we have clearly identified brands and programs that are most critical to both near and latter half of the decade performance. Across the organization, we have initiated efforts to delayer and streamline decision-making. And within R&D, we are optimizing the portfolio to focus our internal efforts on higher ROI programs. These are programs with compelling science, significant commercial value and in therapeutic categories where BMS is positioned and resourced to win. As a result of these actions, we anticipate cost savings of approximately $1.5 billion by the end of 2025, which will allow us to reinvest in high-priority growth brands and R&D programs.
With our heightened focus on improving productivity and efficiencies, we're strengthening the company's long-term growth profile. This is a snapshot of what has been a very busy start to the year. And while we clearly have more work to do this year, we're off to a good start. Let me close on Slide 8. Overall, our business outlook remains unchanged. We remain confident that we will deliver top-line growth for the year consistent with what we communicated in February, and our underlying non-GAAP EPS forecast has also remained unchanged. We are taking important actions to effectively manage the decade. Our management team is focused on ensuring the disciplined execution required to deliver both this year and set us up for the longer term. I want to thank the employees of BMS, including new team members from our recent acquisitions, for their contributions and commitment to delivering for patients.
Let me now hand it over to David. David?
David Elkins: 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 on our momentum coming out of last year, we are 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 in broadening our IO 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 US, partially offset by demand growth. As we said in the past, we expect to see growth at a more modest pace in 2024. Opdualag, a standard-of-care treatment in first-line melanoma, generated strong quarterly sales with US sales growth primarily driven by strong market share.
We are very encouraged by the future expansion potential of Opdualag, not only in adjuvant melanoma, but also in our plans to develop in first-line lung cancer. This, along with the anticipated launch of our Opdivo subcutaneous formulation next year, we will extend our IO franchise well into the next decade. Our targeted solid tumor therapies expanded with the addition of Krazati after the completion of Mirati acquisition in late January. Our reported sales represent a partial quarter, and on a pro-forma basis, Krazati global sales in Q1 were approximately $27 million, primarily in the US. With the recent conditional marketing approval by the European Commission, we look forward to bringing Krazati to more patients toward the end of the year.
Augtyro's first quarter performance reflects positive early sales trends. We remain focused on driving awareness and penetration based upon its potential best-in-class profile. Now moving to Slide 12 and our cardiovascular franchise. Eliquis remains the market-leading oral anticoagulant worldwide. Q1 sales in the US grew 12%, primarily due to strong demand, including increased market share. Internationally, sales were roughly in line with prior year. Camzyos generated strong sales in the quarter, nearly tripling its performance versus Q1 of last year. In the US, sales were driven by demand growth, including an almost 25% increase in commercial dispenses since Q4 of 2023. Sequentially, US sales of Camzyos were impacted by the inventory dynamics of approximately $20 million and gross-to-net impacts from the typical co-pay reset at the start of the new year.
We expect the momentum of Camzyos to continue, supported by the compelling real-world evidence in over 1,500 patients presented earlier this month at ACC. Let's now turn to Slide 13 and discuss our hematology business. Our legacy brand Revlimid saw sales decline in the first quarter. Utilization of free drug program normalized in the quarter. We continue to anticipate variability in Revlimid sales quarter-to-quarter based upon historic dispensing patterns in specialty pharmacies. As anticipated, there is an increased volumes of US generics starting in March. Turning to Reblozyl, growth in the quarter was driven primarily by the strong US launch of the broader commands label in first-line MDS. International sales growth benefited from the new market launches and we look forward to bringing Reblozyl to more patients with the recent first-line approvals in the EU and Japan.
In cell therapy portfolio, global Breyanzi sales growth reflected the strength of the clinical profile and improved manufacturing capacity. Consistent with what we previously communicated, starting in Q2, we expect Breyanzi to benefit from the recent new indications and expanded manufacturing capacity. With Abecma, US performance in the quarter was impacted by ongoing competitive pressures. Future demand will benefit from the recent KarMMa-3 approval, which expands the addressable patient population. Internationally, Abecma demand growth was offset by unfavorable pricing pressures to secure access. Now moving to Immunology on Slide 14. Zeposia sales in the quarter were primarily due to demand of new patient starts in multiple sclerosis. Sotyktu sales performed in line with our expectation.
During the quarter, we delivered on our goal of achieving roughly 10,000 commercially paid prescriptions. Sales in the quarter reflected increased demand and expanded commercial access. In addition, we expect to add another large PBM later this year that will expand access coverage by approximately 30 million lives. Now turning to Slide 15. I will walk you through the remainder of our P&L and my comments will be on a non-GAAP basis. As expected, gross margin decreased compared to the prior year, primarily due to product mix. Excluding acquired in-process R&D, first quarter operating expenses increased mainly due to the impact of the recent acquisitions and higher cost to support the overall portfolio. We expect this growth to be mitigated later in the year through savings and productivity initiatives I will speak to shortly.
Other income and expense declined as expected in the first quarter, primarily due to lower PD-1 royalty rate and the financing costs associated with the recent transactions. Acquired in-process R&D in the quarter was $12.9 billion, primarily due to the previously disclosed one-time charge of $12.1 billion for the Karuna transaction and $800 million for SystImmune. Our tax rate in the quarter was impacted by the one-time nondeductible in-process R&D charge for Karuna. Before the impact of acquired in-process R&D, our first quarter earnings would have been $1.89. Taking into account the impact from the recent transactions, including acquired in-process R&D, we reported an earnings per share loss of $4.40. Now, moving to the balance sheet and capital allocation on Slide 16.
Cash flow from operation remains strong with approximately $2.8 billion generated in the quarter, resulting in approximately $10 billion in cash and cash equivalents and marketable debt securities on hand as of March 31st. Our strategic approach to capital allocation remains unchanged. We are committed to the dividend. And as we said previously, we plan to utilize our cash flow to repay approximately $10 billion of debt over the next two years. And we remain financially disciplined around business development to further strengthen the company's long-term growth profile. Next, let's turn to Slide 17 to discuss our productivity initiative. As Chris described earlier, we have taken action to increase productivity and efficiency and focus our efforts on the assets and opportunities with the highest potential ROI and those most likely to drive our long-term growth.
As part of this process, we are making deliberate choices to prioritize the assets that will have the greatest clinical benefit to impact areas of high unmet need and where we can deliver the most value for patients. We will disproportionately invest in higher return opportunities, which improves our portfolio ROI and strengthens our growth profile in the second half of the decade. After a thoughtful process, we have made the decision to discontinue and externalize several clinical assets. We anticipate cost savings from these actions of approximately $1.5 billion by the end of 2025, thereby absorbing the incremental OpEx expense from the recent deals. These cost savings will come from across the organization and include reductions in direct clinical expense, site rationalization and elimination of open roles and reduction in headcount.
As we realize these savings, we will reinvest in the highest potential opportunities. Now, turning to Slide 18. I'll walk through the impact of our recently closed acquisition on our EPS guidance. As you can see on this slide, if you take our previously-stated non-GAAP EPS guidance range of $7.10 to $7.40 from February and include the previously-stated impact of deal dilution and the one-time impact of acquired in-process R&D. Our revised range continues to reflect the strong outlook of the business as we told you in February. Now, let's walk through the details of our guidance on Slide 19, starting with revenue. As is our practice, we provide revenue guidance on a reported basis as well as on an underlying basis, which assumes currency remains consistent with prior year.
We continue to expect 2024 total revenues to increase in the low single-digit range at reported rates as well as excluding foreign exchange. This reflects our confidence in the growing momentum of our growth portfolio, including products such as Opdivo, Reblozyl, Breyanzi, Camzyos, and Sotyktu. And as a reminder, the sotatercept royalty will be included in the other growth revenue line. We continue to expect gross margin to be approximately 74%. And as we saw last year, we should see a sequential dip in Q2 related to our sales mix. Excluding acquired in-process R&D, we continue to expect our total operating expenses to increase in the low single-digit range, reflecting incremental costs associated with the recent acquisitions, partially offset by the realization of internal savings through the productivity initiative I mentioned earlier.
Given the timing of the deal closures, we expect to come in at the upper end of our guidance range with an expected step-up in Q2 and the remaining OpEx to be more evenly spread across the back half of the year. We remain aligned with our previous operating margin to target at least 37% through next year. For OI&E, we now expect approximately $250 million of expense, primarily reflecting the debt financing costs from Karuna and RayzeBio. The tax rate was affected by one-time non-deductible expense of the Karuna acquired in-process R&D charge, which impacted our non-GAAP net income. Excluding this impact, the estimated underlying tax rate in the quarter was about 19.5%. And as a result, we now see full-year underlying tax rate of about 18%. Before we move to Q&A, let me take a minute to review some of the key highlights on our call today.
We grew the top-line, we advanced the pipeline and we are executing our productivity initiative. And our expectations for the underlying strength of the business remain unchanged from the beginning of the year. Finally, I'd like to recognize our BMS employees around the world for their unwavering hard work and commitment as we continue to make progress in strengthening the company's long-term growth profile and bringing truly transformational medicines to patients. With that, I'll now turn the call over to Tim for Q&A.
Tim Power: Thanks, David. Could we go to the first question, please?
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