Bristol-Myers Squibb Company (NYSE:BMY) Q3 2023 Earnings Call Transcript

Bristol-Myers Squibb Company (NYSE:BMY) Q3 2023 Earnings Call Transcript October 26, 2023

Bristol-Myers Squibb Company beats earnings expectations. Reported EPS is $2, expectations were $1.77.

Operator: Hello and welcome to the Bristol-Myers Squibb Third Quarter 2023 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 this event is being recorded. I would now like to turn the conference over to Tim Power, Vice President of Investor Relations. Please go ahead.

Tim Power: Thank you and good morning, everyone. Thank you for joining us this morning for our third quarter 2023 earnings call. Joining me this morning with prepared remarks are Giovanni Caforio, our Board Chair and Chief Executive Officer; Chris Boerner, our Chief Operating Officer and CEO designate; and David Elkins, our Chief Financial Officer. Also participating in today’s call are Adam Lenkowsky, our Chief Commercialization Officer, and Sarnit 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 Giovanni, Chris and David’s remarks. Before we get started, I’ll read our forward-looking statement. During this call, we 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. With that, I’ll hand it to Giovanni.

Giovanni Caforio: Thank you, Tim, and good morning, everyone. Q3 was a solid quarter for the company. We delivered sales growth for our in-line and new product portfolios and continued to advance the renewal of our business, delivered important clinical and regulatory milestones, and further strengthened the long-term prospects of the company through the planned acquisition of Mirati. On my 49th and last quarterly earnings call, I am proud of where Bristol Myers Squibb is today. We have built a highly diversified business. The strength of our in-line products and the potential of the launch portfolio gives us confidence in the ability to navigate Revlimid LOE through 2025. The focus is clearly on the second half of the decade.

We continue to strengthen our position thanks to a growing registrational stage pipeline and the ability to source external innovation through business development. Our R&D day highlighted the breadth and depth of our research efforts, which provide us with confidence in the long-term sustainable growth of the business. It has been an honor and privilege to work alongside my talented and dedicated colleagues at BMS over the past 23 years and to help grow this company into the industry leader it is today. You all know Chris very well and I am sure you will share my confidence in him as a leader. I’m excited to see the company’s continued progress in delivering against our critical patient-centric mission. My sincerest gratitude goes out to all our employees for the work they have done and will do to enable BMS to improve outcomes for millions of patients around the world.

With that, I’d like to turn it over to Chris to talk more about the quarter.

Chris Boerner: Thank you, Giovanni. Before I dive in, on a more personal note, I want to recognize Giovanni for his tremendous impact on the organization. He is consistently focused on ensuring that we are strengthening our company while delivering for patients, and I wish him every success in his next chapter. Let’s start with our third quarter overview on Slide 5. As Giovanni said, we delivered continued top line growth for the in-line and new product portfolio during Q3. We also advanced our pipeline and announced an important business development transaction with the planned acquisition of Mirati. You’ll have seen that we are increasing our non-GAAP EPS guidance for the year. We also updated our target for our new products to grow to more than $10 billion in 2026 and for our operating margin to be above 37% while reaffirming our other 2020 to 2025 guidance.

I will give you more color on our outlook in a moment, so let me step back and provide some context. Let’s turn to Slide 6. As I told you last month at our R&D day, my objective as incoming CEO is to continue to position our company for sustainable long-term growth. Three levers I outlined there were commercial execution, R&D leadership, and strategic business development. I’d like to take a minute to tell you where we are on each of these, starting with commercial execution on Slide 7. David will provide more details in his remarks about our commercial results, but let me describe how I think about our performance and outlook. Let’s start with our key in-line products, where we are seeing good growth. Eliquis demand growth in the U.S. is strong with continued opportunities for growth going forward.

Consistent with previous years, revenues in Q3 were impacted by gross-to-net adjustments. We expect these to normalize through Q4 as we’ve seen in previous years. Opdivo continued to see good demand growth in Q3. Importantly, we’ve delivered a number of important future growth drivers with new data and approvals during the quarter, that I will describe momentarily. David will provide highlights for the remainder of the in-line and LOE portfolio. Turning to the new product portfolio. Overall, our new products continue to perform well, providing confidence in the portfolio’s growth potential and ability to diversify our business over the long-term. I would characterize the performance of these products in three categories. First, we are seeing strong performance for a number of products, including Reblozyl, Opdualag, and Breyanzi.

Specifically for Reblozyl, we’re seeing strong growth with a broad label for Commands. As Adam can discuss further, we are seeing encouraging trends in both first line and second line. We are also very pleased to see that the NCCN guidelines recognize the importance of Reblozyl as an important treatment in first line MDS for both RS-positive and RS-negative patients. For Opdualag, growth was also robust for the quarter and the product is on the path to become the new standard of care in first line melanoma. This product has considerable growth opportunity remaining in its existing indication and we are continuing to study its potential in future indications, which Sarnit can speak to. Breyanzi performance was strong for the quarter and we expect strengthening performance for this product heading into 2024 as manufacturing performance and supply continue to improve.

Second, there are a couple of products, notably Camzyos and Sotyktu, where performance is strong but growth has been slower than expected. For Camzyos, we continue to see steady increases in use and all feedback metrics from customers and patients continue to be very strong. At the same time, getting cardiovascular accounts on-boarded and the pace of getting patients onto therapy, as patients may see their cardiologist only one to two times per year, has resulted in a longer adoption curve. As we have shared, we expect consistent and steady growth akin to a cardiovascular launch for this important product, and we remain confident in our long-term projections. For Sotyktu, the profile continues to be strong and we’re seeing nice increases in share.

Access continues to be the main constraint for this brand, and while we will see broad and meaningful access improvements in 2024, getting to zero step edits will take a bit longer than anticipated for some key plans given emerging payor dynamics in the immunology market. Importantly for both of these products, our peak expectations remain unchanged, though the time to peak will shift. Finally, I would highlight Abecma and Zeposia, where performance has lagged expectations. For Abecma, in-class competition and dynamics with bi-specifics in late line multiple myeloma have impacted performance. At the same time, real world data generated by a consortium of KOLs demonstrates that our efficacy, safety and reliability are quite competitive. This has been further strengthened by recent data in triple-class refractory patients who receive bridging therapy, presented at the IMS conference.

Our focus will be on ensuring our teams are fully leveraging this breadth of data to effectively reinforce the profile of this important treatment. For Zeposia, performance remained strong in MS. In UC, access has been a constraint that will require continued focus to unlock future growth. Again, Adam can provide additional context. Taken together, we now expect sales from this portfolio to be $3.5 billion in 2023. This is slightly lower than we had expected at the start of this year. Looking forward, we see continued growth. In the medium term, we do expect to achieve greater than $10 billion in sales for this portfolio in 2026, rather than 2025. The commercial team is laser focused on building on the momentum of performance in the quarter and, importantly, accelerating performance where necessary.

We are also further increasing our investment behind selective brands to ensure performance accelerates. Finally, I would highlight that our new product portfolio will expand this quarter with the addition of repotrectinib next month and, upon completion of the Mirati transaction, Krazati. Turning now to our R&D engine on Slide 8, as I mentioned last month, we have exciting opportunities to strengthen our pipeline and deliver more important medicines to patients across therapeutic areas, including expanding our registrational pipeline from six to 12 assets over the next 18 months. Since our R&D day, we’ve continued to make progress. In oncology for Opdivo, we’ve delivered several growth drivers, including U.S. approval in stage 2 adjuvant melanoma, presentation of positive data for peri-adjuvant lung with CheckMate -77T and for first line bladder cancer with CheckMate -901, and importantly we’ve met the co-primary endpoints for the sub-cutaneous nivolumab trial, CheckMate -67T.

This has the potential to open a regulatory approval in indications that constitute approximately 65% to 75% of today’s Opdivo business in the U.S. and extend franchise durability into the 2030s. You may have also seen that Mirati presented encouraging PD1 combination data in first line lung cancer at ESMO. These data further strengthen our conviction in the potential of Krazati and the value it will add to our oncology portfolio. This builds on the previously granted fast-track designation from FDA for the idiopathic pulmonary fibrosis indication. These actions reinforce the potential importance of this asset in these diseases with high unmet medical need. Importantly, our CD19 NEX T cell therapy is making progress. We have started dosing patients in our LPA study and today I can disclose that we have now achieved clearance from the FDA to begin our MS trial.

These are important milestones that illustrate our strategy of rapidly advancing cell therapies into immunologic diseases and becoming leaders in the space. We are moving forward with other assets in our pipeline. You can expect to hear more about our hematology assets at ASH later this year and about ARLDD at a medical conference early next year. Turning to business development, a key priority for capital allocation on Slide 9. As you know, BD has been a key component of our strategy to supplement our internal innovation. Our recently announced planned Mirati acquisition is an excellent example of a transaction with great strategic fit, compelling science, and financial soundness. Through this acquisition, we’re strengthening and diversifying our oncology portfolio with the addition of Krazati and potentially PRMT5, along with a pipeline of future KRAS inhibitors and enabling programs.

We maintain significant cash flow to support continued investments in business development, and this will remain a top priority for capital allocation for the company. Turning now to our scorecard on Slide 10, I’ve already discussed many of the positive recent milestone achievements noted here. While we recently learned that the second line HCC study for Opdualag did not support moving forward in a registrational trial for this indication, we have a second study underway in first line liver cancer that we expect to read out next year. In addition, as discussed already, we’ve seen a number of important accomplishments not included on this slide, notably first line bladder and subcu Opdivo. All of this speaks to continued strong pipeline execution and the progress of programs that will become important catalysts for future growth.

Turning to Slide 11, when you add everything up, as we discussed last month, we have numerous levers to drive growth into the back half of this decade and beyond. I’m confident in our ability to transform our portfolio both organically as well as through business development, and to deliver new medicines for patients. With that, I’ll turn it over to David to walk you through our product performance and financial results in more detail. David?

David Elkins: Thank you Chris, and thanks to all of you for joining our third quarter earnings call. Turning to Slide 13, let’s discuss our top line performance. Unless otherwise stated, all comparisons are made versus same period in 2022, and sales growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange. Total company sales in the third quarter were $11 billion, driven by continued growth of our in-line and new product portfolio, offset by the expected decline in Revlimid sales. Let’s move to our new product portfolio on Slide 14. During the quarter, we delivered solid growth for the portfolio with $928 million in revenue. Growth was strong across the portfolio, but we have seen an impact of Abecma from both manufacturing site maintenance in June and from increased availability and usage of alternative BCM targeting therapies for multiple myeloma.

Based on the performance year-to-date, we now expect the new product portfolio to deliver roughly $3.5 billion for the full year 2023. This is primarily due to the impacts of our cell therapy franchise, particularly Abecma. As Chris mentioned, we are laser focused on continuing to accelerate growth of our in-line and new product portfolio into the next year and beyond. Let’s discuss performance of our solid tumor products on Slide 15. Our flagship oncology product, Opdivo, continues to grow well with sales up 11% globally. In the U.S., Opdivo grew 9% primarily driven by demand. Sequentially, sales grew double digit driven by demand and a reversal of roughly $50 million of unfavorable buying patterns in the second quarter. Outside the U.S., third quarter revenues increased 15%, primarily driven by demand for indications such as lung and gastric cancer.

This performance along with potential new launch opportunities in peri-adjuvant lung and first line bladder, as well as in recently approved adjuvant melanoma indication reinforce our confidence in the continued growth for Opdivo. As Chris mentioned earlier, we now have positive data for the sub-cu formulation. We believe this supports the potential for an important new option for patients and strengthens the franchise longevity into the next decade. With respect to our next-generation IOS at Opdualag, revenue nearly doubled as we build share in first line melanoma. In the U.S., we now see market share of roughly 25% with additional room to grow, particularly in the approximately 15% of patients that are still receiving PD1 monotherapy. Opdualag has become a new standard of care in patients with metastatic melanoma, where BMS’ total share is 65% in this important market.

Let’s now turn to cardiovascular on Slide 16. Eliquis continued to grow with $2.7 billion in revenue in the quarter. In the U.S., sales grew 4% year-over-year driven by strong demand growth offset by unfavorable gross-to-nets due to channel mix, including impact of approximately $75 million in Q3. Internationally sales were primarily impacted by generic entries in Canada and the U.K. and pricing pressures we’ve mentioned in the past. At the same time, we’re encouraged to have successfully defended our IP in several EU countries this year, including France, Norway, and Sweden. Moving to Camzyos, our first-in-class obstructive HCM product, we are pleased with the continued growth of the product, delivering $68 million of revenue in the quarter.

In the U.S., we added roughly 1,000 patients both to our hub and to commercial dispense. We are very encouraged to see good persistence with roughly 3,500 patients now on commercial drug. Our patient base continues to grow as we steadily bring more patients onto treatment and convert to commercial dispense. Turning to our hematology products on Slide 17, starting with Revlimid, global sales in the quarter were just over $1.4 billion. At this point, we expect revenues of approximately $6 billion for the full year, primarily due to higher level of demand for lenalidomide. Now onto Pomalyst, global revenues were down 2% versus prior year mainly due to free product dynamics in the U.S. we described in July. Internationally, demand for Pomalyst was stable.

Revenues also benefited from a $40 million clinical supply purchase during the quarter. Turning to Reblozyl, which generated revenues of $248 million in the quarter, in the U.S. revenue growth accelerated, increasing 28% year-over-year primarily driven by increased demand. With the Commands approval, we are seeing increased use in first line as well as an increase in second line patients that are rapidly switching from ESAs to Reblozyl, along with a continued increase in duration of treatment. Though it’s early in the launch in first line MDS, we’re hearing very positive feedback on the profile, especially in the community setting. Overall, we’re encouraged by the strong label for Reblozyl in first line MDS-associated anemia, and we believe it sets us up well to deliver this medicine to more patients with this disease.

Moving to Abecma with revenue of $93 million in the quarter, this was impacted by the manufacturing site maintenance in June and the use and available of other BCMA targeting agents. Turning to Reblozyl, sales in the quarter were $92 million, more than double versus prior year and down slightly compared to prior quarter due to timing of infusions. As we mentioned in July, during the quarter we remained constrained with respect to vector; however, with continued strong demand in second and third line-plus large B-cell lymphoma and an expected increase in supply next year, we are confident in our ability to grow in 2024 and beyond. Let’s move to our immunology products on Slide 18. Global sales for Zeposia were $123 million, up 75% compared to prior year.

In the U.S., in addition to $15 million contribution due to favorable gross-to-nets and inventory in the quarter, we continue to be pleased with the momentum in multiple sclerosis with a best-in-class share within the S1P class and continued volume growth in the very competitive ulcerative colitis market. Outside the U.S, sales increased mainly due to demand in MS. Turning to Sotyktu, underlying launch trends remain strong. Sales in the quarter were $66 million, which included a clinical supply purchase of approximately $30 million, and we saw continued strong volume demand during the quarter. With over 38,000 script equivalents dispensed since launch, we’ve delivered over 15,000 script equivalents in the U.S. during the third quarter. Within the oral category, our share is now roughly 40%, reinforcing that Sotyktu is establishing a position as the oral of choice in this market, and we are making progress converting covered CVS patients from the free drug program to commercial dispense.

We expect this will take on average two to three months per patient. Building on our momentum, we continue to expect the further strengthening of access next year. Now moving to the P&L on Slide 19, I will focus my remarks on a few non-GAAP key line items, having just covered sales performance. Compared to Q2, gross margin was favorably impacted by product mix. Acquired in-process R&D in the quarter was $80 million, which was partially offset by $12 million of licensing income, resulting in a net impact of $0.03 of EPS. The reduction in the effective tax rate during the quarter was primarily due to recently issued Section 174 guidance regarding deductibility of certain research and development expenses. This resulted in an adjustment in the quarter to our estimated tax rate.

Overall, third quarter earnings per share was $2.00 per share, growing approximately 1%. Turning to the balance sheet and capital allocation on Slide 20, cash flow generation and our balance sheet remain strong. Cash flow from operations in the quarter was approximately $4.8 billion with over $8 million in cash and marketable securities on hand at the end of Q3. Our capital allocation approach remains focused on business development as a top priority, with the planned acquisition of Mirati as an example. We also remain focused on growing our dividend and on opportunistic share repurchases. In this regard, during the quarter we executed $4 billion of ASR and expect that to be completed by the end of the year. Today, we have roughly $2 billion of authorization outstanding.

Lastly, turning to our 2023 non-GAAP guidance on Slide 21, we continue to expect revenue to decline in the low single digits compared to last year. As mentioned, we expect new products to be about $3.5 billion this year and for Revlimid to deliver about $6 billion. Turning to opex, we continue to expect roughly low single digit decline compared to last year, corresponding to roughly $4.4 billion expected in the fourth quarter. Based on the changes to tax I described earlier, we are revising our full year effective tax rate to 15.5%. With respect to our earnings, we have increased the midpoint of our non-GAAP EPS guidance and narrowed the range to $7.50 to $7.65. With respect to our medium term guidance on Slide 22, as Chris described earlier, we reaffirm our low to mid single digit revenue CAGR from 2020 to 2025 and the $8 billion to $10 billion growth from our in-line portfolio during this period.

We have adjusted our new product portfolio target to greater than $10 billion in 2026, a year later than previously communicated, and with respect to operating margin, [indiscernible] our target to greater than 37% through 2025 to reflect continued strong profitability while enabling flexibility to invest in future growth and incorporating the dilution from Mirati. Now before we turn it over to questions and answers, I’d like to recognize Giovanni’s leadership of the company and thank him for his considerable contributions in transforming BMS. I also want to acknowledge the hard work of our teams around the world during the quarter. I know that our people remain focused on delivering for patients and will continue to do so under Chris’ leadership moving forward.

I’ll now turn the call back over to Tim, Giovanni and Chris for Q&A.

Tim Power: Thanks very much, David. Before we go to the first question, we know it’s a very busy morning. We want to get to as many questions as we can, so if you can try to keep to just one question per person, that would be very much appreciated. Keith, can we go to the first question, please?

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Q&A Session

Operator: Yes, thank you. We will now begin the question-and-answer session. [Operator instructions] The first question comes from Chris Schott with JP Morgan.

Chris Schott: Great, thanks so much. Just maybe for me, just a bigger picture question. You’re lowering the 2025 targets. It sounds like there’s a couple of the products that adoption is just taking longer than expected. I guess, what gives the company confidence that this isn’t kind of a different dynamic with some of these products that isn’t going to enable maybe some of those longer term targets as you look out to 2030, that you’ve announced before. So maybe just kind of elaborate a little bit more on how much of — how do you make sure the company is positioning itself to hit those longer term peak sales? And do we need to maybe just rethink some of the peak sales potentials of some of these assets, given what we’ve learned from the launches over the last year or so? Thanks so much.

Chris Boerner: Thanks, Chris. This is Chris – I’ll start, and then I’m going to turn it over to Adam. I think it’s important to step back and be clear on what we’ve said on this call. First, I think it’s important to recognize that for the new product portfolio in totality, we continue to see very strong long-term potential, consistent with what we’ve said previously. There’s been no change in the conviction for this portfolio overall, and in fact the question really is a question of when, not if. We have, however, recognized the timing change that we’ve communicated today, and that’s really around a few things. First, there are, as I mentioned in the prepared remarks, a number of products where expectations — where performance is achieving, if not exceeding expectations.

However, we also have to acknowledge that there are a few products where the dynamics are different. For products like Sotyktu and Camzyos, the reality is while the long-term potential for these products remains unchanged, it’s taking a bit longer, and Adam can speak to those dynamics. And there are a couple of products where performance needs to change. And so, for example, with Abecma and Zeposia, we know that we’ve got challenges there. The team is re-orienting and making sure we’ve got the right resources and focus on delivering for those products. But I think it’s important that when you step back and look at the portfolio in totality, our conviction around these products and the importance that these products will play in terms of driving long-term growth and helping us diversify the business, that remains unchanged.

You then layer on that to good in-line performance with products like Eliquis and Opdivo, we’re as confident as we have been on the long-term growth profile of the company. The focus right now is around executing on the commercial side, continuing to move the pipeline forward, and ensuring that we’ve got the right focus on bringing innovation in externally with business development. Adam, anything you would add?

Adam Lenkowsky: No, I think you covered it very well.

Chris Boerner: Thanks, Chris.

Tim Power: Thanks Chris. Keith, can we go to the next question, please?

Operator: Yes, and that comes from Geoff Meacham with Bank of America.

Geoff Meacham: Good morning, everyone. Thanks for the question. You have recent data for sub-cu Optivo. I guess the question is, what’s the incremental benefit here, and maybe how strategically important is this approach, just given IRA implementation and potential opportunities to extend the LOE? Thank you very much.

Chris Boerner: Thanks Jeff, I’ll start. In spite of a lot of the progress, when you look at IO, there are still opportunities we know to improve patient experience and address the treatment burden that exists with these assets, and that’s really where sub-cu comes into play. And we’re very pleased with the data that we’ve seen with 67T. The data are compelling in our view, and we look forward to after we finish the review presenting those at an upcoming conference and obviously engaging with regulators. The way we’ve thought about the sub-cu program consistently is that this would address specific patient needs, as well as the opportunity to address those centers were, for example, chair time is at a premium, and that’s still where we think this will go.

We think that these indications will represent somewhere between 65% and 75% of the Opdivo business as it sits today, and with focused effort we think we can convert roughly about 50% of the overall business over time, and so that’s really how we’re thinking about it. And if we’re successful in doing that, we think this has the potential to extend the franchise into the early 2030s.

Tim Power: Thanks Chris. Keith, can we go the next question, please?

Operator: Yes, and that comes from Luisa Hector with Berenberg.

Luisa Hector: Oh, hi, thank you for taking my question. Still on the medium term outlook, can you confirm that there is no contribution from Mirati in that guidance, and then perhaps some comments around the lower margin expectation, is that purely linked to new product revenue guidance or are there other factors at play? Thank you.

David Elkins: Thanks for the question. So the long-term guidance for the new product portfolio does not include anything related to — from a Mirati sales perspective. If you do recall, we did say the dilution next year related to Mirati is about $0.35. As it relates to the margin, that does factor in how we view our margin going forward. If you recall previously, our mid-term guidance is margins above 40%, but we continue to see opportunity to invest in our launch portfolio and invest behind products like Camzyos and Sotyktu, as well as our cell therapies, but also we continue to see opportunities in our portfolio. As you know, we had multiple read-outs this quarter, LPA being one of those, as well as additional indications for Opdivo, and we have first line Commands.

But as we step back and what we shared at R&D Day, we see opportunities to continue to accelerate in our R&D pipeline. So that’s why we revised our guidance to incorporate the dilution from Mirati but as well as the investments that we’re making in the new product portfolio and the R&D portfolio.

Tim Power: Thanks, David. Keith, can we go to the next question, please?

Operator: Yes, and that comes from Seamus Fernandez with Guggenheim.

Seamus Fernandez: Thanks for the question. So just trying to get a little bit of a better sense on the 37% margin guidance. Is that something that we should anticipate is a potential floor in 2024 as you lose the Keytruda royalty, or is it really sort of a sequential floor for margins in 2025 as you lose Sprycel and Pomalyst, following the loss of the Keytruda royalty? Just trying to get a sense of kind of the path to 2025 as we move through the balance of this year and next year. Thanks.

David Elkins: Yes, thanks, Seamus, for the question. And the 37% guidance is a floor that we’ve provided as we look forward to that midterm period, which is 2025. We haven’t provided guidance yet. We’ll do that on the fourth quarter earnings call as it relates to 2024, which I think is what your question is getting after. I’d say the one thing to think about is, one, we’ve talked about Revlimid in the past and we’ve said, we’ve revised Revlimid’s guidance this year from $5.5 billion to $6 billion, and we still see next year stepping down to about that $4 billion, and then we’ll update you on all the other line items when we do our fourth quarter earnings as far as profitability next year. But you should think about the operating margin as a floor as we look forward through ’25.