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spk06: Good morning. My name is Dennis and I will be your conference operator today. At this time, I would like to welcome everyone to the Bristol Myers Squibb fourth quarter 2022 earnings conference call. All lines have been placed on mute to prevent any background noise. After the speaker's remarks, there will be a question and answer session. If you would like to ask a question during this time, simply press star then the number one on your telephone keypad. To withdraw your question, press star one again. I would now like to turn the conference over to Tim Power, Vice President of Investor Relations. Please go ahead.
spk09: Thank you, and good morning, everyone. Thanks for joining us this morning for our fourth quarter 2022 earnings call. Joining me this morning with prepared remarks are Giovanni Coforio, our Board Chair and Chief Executive Officer, and David Elkins, our Chief Financial Officer. Also participating in today's call are Chris Berner, our Chief Commercialization Officer, and Simon Herlot, our Chief Medical Officer and Head of Global Drug Development. As you'll note, we've posted slides to BMS.com that you can follow along with for Giovanni and David's remarks. Before we get going, I'll read our forward-looking statement. During this call, we'll make certain 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 over to Giovanni.
spk14: Thank you, Tim, and good morning, everyone. Starting on slide four, I am pleased to report another strong quarter for Bristol Myers Squibb, concluding a very successful year. Last year was an important year for our company, the first with Revlimid Generics. Given that, I am very proud to say that in 2022, we grew our business and made tremendous progress advancing our pipeline, including launching three new first-in-class medicines, and progressing six promising programs into registrational development. While David will provide additional details on the financials in a moment, I will point out a few highlights. Last year, we delivered revenue growth of 3%, adjusting for foreign exchange. Importantly, growth was driven by our in-line and new product portfolios. So I am pleased to note that we delivered continued strong growth in the fourth quarter for these assets, up 12% adjusting for foreign exchange. We also grew our earnings, including non-GAAP EPS growth of 8% for the full year. As we start 2023, I am confident we have established a strong foundation for Bristol-Myers Squibb. As you'll note from our guidance, We expect to grow both revenue and non-GAAP EPS this year. Importantly, we remain on track to achieve the commitments we have made for 2025. Given increasing confidence in our new product portfolio and continued progress with our broader pipeline, we see multiple paths to growth through 2030. Let me now provide some perspective on 2022. On slide five, you can see our overall pipeline execution last year. I am very pleased with our progress, which further supports renewal of our portfolio. While we advanced on many fronts, I would like to highlight a few accomplishments. Approval of three first-in-class medicines, including Obdualag, Kansaius, and Sotictu, which address areas of high unmet medical need and have significant commercial potential. Further progress expanding the reach of our new product portfolio, including an important expansion opportunity for Reblosil in first-line MDS with commands, positive top-line results of CARMA-3, based on which abecma is the first BCMA CAR-T to have demonstrated superiority to standard regimens in relapsed and refractory multiple myeloma, and initiation of registrational trials for Soticto in lupus. Remember, in the Phase II study, Soticto demonstrated an encouraging profile in this hard-to-treat disease. We believe lupus can be an important expansion opportunity for the brand. Progress with the next generation of medicines includes important proof-of-concept data for milvexian in secondary stroke prevention. enabling the initiation of the Phase III program this year, and a positive trial for our LPA1 asset in lung fibrosis. This asset has come into focus only recently and is a prime example of the optionality that comes from having a broad pipeline. We are looking forward to presenting data and starting Phase III trials for this asset later this year. On slide six, you can see how we strengthened the outlook for our new product portfolio, which, as you know, is central to our strategy of renewing our portfolio over the coming years. Our pipeline execution and strong commercial momentum position us well to achieve 10 to 13 billion of risk-adjusted revenue in 2025. And as a result of the strong progress with our pipeline, we have significantly de-risked the 25 billion plus of long-term non-risk adjusted revenue potential. As you can also see on this slide, we continue to see exciting catalysts ahead for these assets. So turning to our scorecard for this year on slide seven, it's encouraging to observe the breadth of catalysts we see ahead as a company in the near term. I point out a few highlights. Just last week, we announced our Phase 1-2 trial for Brianzi in relapsed refractory CLL met the primary endpoint. In Europe, we expect to launch CAMZIOS in obstructive HCM and are pleased to have received positive CHMP opinion for our first and only selected TIK2 inhibitor, SOTIK2. Our ROS1 inhibitor, ripotreptinib, is expected to be filed in the U.S. in lung cancer. We have an important expansion opportunity for Revlozil in first-line MDS. Along with our partners at Janssen, we have embarked on registrational trials for Milvexian, and we expect to move Abecma into earlier lines of therapy. Finally, we are further advancing our multiple myeloma Selmore program with a head-to-head study of Iberdomide versus Revlimid in the post-transplant maintenance settings. As we have done in the prior years, we look forward to updating you on our progress as we continue to advance our pipeline and further support our portfolio renewal. Turning to slide eight, I'd like to remind you about what we've accomplished in the past few years and how that prepares us well for the near, mid, and long term. When we began the transformation of our company three years ago, we told you, what we believed we could achieve, and we have delivered across the board. Financially, we have grown our company, over-delivered synergies, reduced our debt, and generated significant cash flows. We have launched all nine new medicines, including three first-in-class products that were approved last year. And we've continued to execute disciplined business development to further support our growth profile in the future. Our record of execution further strengthens my confidence in our ability to renew our portfolio and deliver long-term growth. With all of this in mind, let me move to slide 9 to discuss our outlook for this year and beyond. As you know, we expect to drive growth through 2025 and sustain strong profitability as we transform our portfolio. And that journey continues this year. We delivered growth through Revlimid generics in 2022, and as you can see from our guidance today, we expect to continue to grow this year. With the focus turning to the second half of the decade, we continue to see multiple paths to growth, driven by growth of the new products, contribution from our advancing late-stage pipeline, including Milvexian, LPA1, and the cell modes, and significant optionality from our early pipeline, complemented by flexibility for additional business development. All the while, we are transforming our portfolio to be younger, more diversified, and more resilient in the face of an increasingly complex pricing environment in the US and internationally. Before I turn to David, let me express my gratitude to our teams across the globe. starting with our research and development organization, which had a stellar 2022. As you will have seen, this week we announced Dr. Rupert Vesey's decision to retire, effective July 3rd. I want to thank Rupert for his extraordinary contributions since he joined BMS as a result of the acquisition of Celgene. Rupert led the successful integration of research. and the development of a strong pipeline across all stages of development. We are now combining development across early and late stage under Summit's leadership and preparing to transition the research organization to report to Dr. Robert Trench, who will serve as EVP and Chief Research Officer when Rupert retires this summer. The focus and determination of these leaders and all of our teams will enable us to continue to deliver for the patients depending on us. I'll now turn it over to David to walk you through the financials.
spk17: David. Thank you, Giovanni, and thank you all again for joining our call today. I know this is a busy morning for all of you. As Giovanni mentioned, 2022 was another solid year of execution for Bristol-Myers Squibb. Let's get started with our top line performance on slide 11. Unless otherwise stated, all comparisons are made versus the same period in 2021 and sales performance growth rates will be discussed on an underlying basis, which excludes the impact of foreign exchange. We delivered on our full year commitments with sales of approximately $46 billion, with growth of 3%. Demand for our diversified inline and new product portfolio was strong, with revenue growth of 13% for the year, more than offsetting the loss of exclusivity for Revlimid in the first year of generic entry. Let me dive deeper now into fourth quarter and full year performance of our new product portfolio on slide 12. Global revenues in the quarter were $645 million, up 87%, while full year revenues topped over $2 billion, nearly doubling over 2021. With nine new product approvals and multiple additional indications coming to fruition, we have an increasingly de-risked new product portfolio. This provides us confidence that we are on track to deliver the potential of our new product portfolio with $25 billion of non-risk-adjusted revenue expected at the end of the decade. Moving to slide 13 to discuss our performance of our solid tumor portfolio, global Adivo sales reflect strong demand for our newly launched and core indication, with double-digit growth in the fourth quarter and the full year. In the U.S., fourth quarter revenue saw full-year sales grow strong, growing 13% and 15% respectively. This growth was primarily driven by demand for our new metastatic and adjuvant indications, partially offset by declining second-line eligibility, as well as some use of OptiLag and first-line melanoma. Internationally, revenues grew 20% in the fourth quarter and 14% for the full year. Fourth-quarter revenue growth was largely driven equally by demand and timing of shipments. Demand was primarily driven in new indications, particularly first-line lung and upper GI cancers. As we look to this year, we expect growth of Opdivo to continue. This growth will come from an expanded indications in both early and late stage cancers. Now turning to our first in class LAG3 inhibitor, Opdilag, which had an impressive first year on the market. Approved in the US in late March, Opdilag generated sales of $252 million in 2022. Sales in the fourth quarter at strong sequential growth of 24% versus quarter three. With first-line melanoma market share now in the high teens, we continue to see room for growth of Opti-Lag in first-line melanoma, where PD-1 monotherapy share still is approximately 20%, and further potential with pivotal studies in adjuvant melanoma and second-line plus colorectal cancer underway. On slide 14, let's discuss our growing cardiovascular portfolio, starting with Eliquis, which had another great year. global revenues in the fourth quarter in the full year grew 6% and 14% respectively. In the U.S., fourth quarter sales increased 15%, driven primarily by demand and favorable gross to net adjustments. Internationally, Eloquist is the leading OAC in many countries. Given high market shares across these countries, demand growth has been offset by pricing measures as well as generic entry in Canada, the U.K., and the Netherlands. Now, turning to our first-in-class myosin inhibitor, ChemZyos. Sales in the fourth quarter were $16 million. We are pleased with the progress we have made since the launch in May of 2022. We laid a strong foundation to REM-certify over 2,600 healthcare professionals and enabled key centers to get operationally ready to make ChemZyos available to patients. We also significantly increased the number of patients on commercial dispensed drug, which provides strong momentum heading into this year. We look forward to continuing this momentum as well as bringing chemzias to European patients with approval expected by mid-year. Moving to our hematology portfolio on slide 15, starting with Revlimid, global sales for the full year were approximately $10 billion, impacted by generic entry. As we noted last year, we expected variability quarter to quarter, and in 2022, we saw slower than anticipated utilization of generic lenalidomide in the U.S. With favorability in 2022 and anticipated increase in generic volume this year, We expect revenues to be approximately $6.5 billion in 2023. We continue to expect an average $2.5 billion annual step down as a reasonable assumption for 2024 and 2025. POMELA's global revenues continue to grow in the fourth quarter and for the full year, driven primarily by demand for triple base regimens in earlier lines of therapy and extending duration of treatment for patients. As usual, in the first quarter, I would like to remind you of the typical seasonality of Revlimid and POMOS experience due to patients entering the Medicare coverage gap early in the year. Now moving to Rebazil, our first-in-class EMA. Demand for Rebazil was strong, with fourth-quarter and full-year sales growing over 30%. In the U.S., revenues grew over 20% in both the fourth quarter and full year. We have made great progress since launch by increasing patient adherence, extending treatment durations, and accelerating switches when ESAs fail. Internationally, Rebizel continues to launch in different markets across the globe, with launches now in 16 markets outside the U.S. Growth continues to be driven by demand in both MDS and beta-thalassemia-associated anemia, and attaining reimbursement in additional countries. Turning to our differentiated cell therapy portfolio of Beckman and Brionzi, Our first-in-class BCMA cell therapy at Beckman continued its robust performance. Global revenues for the full year were $388 million versus $164 million in 2021. This represents strong growth year over year, reflecting significant patient demand and the work the company has done to increase manufacturing capacity. We're being focused on continuing to ramp up capacity and believe this will enable us to get Beckman to more patients with highly refractory myeloma as well as preparing to move into earlier lines of therapy. Lastly, moving to our best-in-class CD19 cell therapy, Breonzi. Global sales for the year were $182 million, more than doubling over 2021. Sales in the quarter reflect strong demand and hard work of our teams to expand supply. Looking to this year, we continue to expect growth driven by demand for Breonzi and second-line plus large B-cell lymphoma, and we will remain focused on continuing to build manufacturing capacity to further support the uptake and prepare for additional indications. Now, let's move to our expanded immunology portfolio on slide 16, starting with our first-in-class S1P agonist, Ziposia. Fourth-quarter sales grew 69%, while full-year global sales nearly doubled, driven by increased demand of multiple sclerosis and ulcerative colitis. Our strategy to expand volume and to improve commercial access is materializing. We've made progress with several plans with either zero or one step at it, which will meaningfully expand access as we move in 2023. We expect continued growth of Supposio to evolve, primarily from MS today to UC over time. And remember, as with any new immunology medicine heading into the first quarter, the typical dynamics of co-pays resetting each year tend to impact the first quarter performance as additional co-pay supports affects gross to net adjustments. Internationally, we are continuing to focus on securing reimbursement in additional markets to get Supposita more patients living with MS and UC. Finally, turning to our first-in-class TIK2 inhibitor for moderate to severe plaque psoriasis, so TIK2. We're extremely pleased with the U.S. launch so far. Still early days, but physician feedback has been outstanding. As of December, we had over 2,000 script equivalents on bridge and commercial drugs. Since then, we continue to make progress with new scripts and see that the use of SOTIC2 is roughly evenly split across systematic naive patients, atesla switch patients, and biologic switch patients. We remain focused on driving demand for this new medicine as the oral choice and ensuring as many patients as possible get SOTIC2 to enable broader formulary positions in 2024. Internationally, we are now approved in Japan and Canada with expected European approval by mid-year. Switching gears to our fourth quarter P&L on slide 17. Having just covered sales performance, let me walk you through a few non-GAAP key line items. As expected, fourth quarter gross margin was impacted primarily by product mix and higher manufacturing costs. For the full year, gross margin was in line with our prior guidance at approximately 79%. Excluding acquired in-process R&D, fourth quarter and full year operating expenses decreased primarily due to reallocation of investments behind our growth opportunities and the impact from foreign exchange and dilution from the turning point acquisition. Acquired in-process R&D in the quarter was $52 million, which was partially offset by $16 million of licensing income that benefited OI&E in the quarter. Fourth quarter effective tax rate was approximately 11%, driven by earnings mix and one-time items, with the full year tax rate of approximately 15%. Overall, fourth quarter earnings per share was $1.82. From a full year perspective, we ended the year at the upper end of our guidance range at $7.70, representing 8% over previous year. Moving to the balance sheet and capital allocation on slide 18. Cash flow from operations in the fourth quarter was $3.3 billion. The company's balance sheet remains strong with approximately $9 billion of cash and marketable securities on hand as of December 31st. Our capital allocation priorities are unchanged. Business development remains a top priority to further renew and diversify our portfolio and strengthen our growth outlook, while also focused on balance sheet strength and returning capital to shareholders. We have executed several early-stage business development deals, as well as acquiring Turning Point Therapeutics last year. A strong balance sheet allows us to be size agnostic on deals. As it relates to balance sheet strength in 2022, we reduced debt by over $5 billion, and we are committed to maintaining a strong investment-grade credit rating. And finally, as it relates to returning capital to shareholders, we have a long-standing track record of paying dividend for 91 consecutive years and recently grew the dividend for the 14th consecutive year. We remain committed to growing the dividends. subject to board approval, and continue to be opportunistic on share repurchases, with approximately $7 billion remaining in our share repurchase authorization. Let me close with our 2023 non-GAAP guidance on slide 19. Due to unpredictable macroeconomic factors and large swings in foreign exchange last year, we were providing guidance on a reported basis as well as an underlying basis, which assumes currency remains consistent with prior year. We expect 2023 revenues to grow approximately 2% on a reported and constant currency basis. This reflects our confidence that our in-line and new product portfolios will more than offset the LOE impact from Revlimid and Abraxane. We expect Revlimid sales to be approximately $6.5 billion, which assumes additional step-up to generic manufacturers later in Q1, as well as continued variability quarter to quarter. With the momentum of our new product portfolio, we expect it to roughly double versus last year and will be approximately $4 billion. As it relates to our line item guidance for the year, we expect our gross margin to be approximately 77%, which reflects a shift in product mix. We do not predict acquired in-process R&D, so excluding this, we expect our total operating expenses to decline in a low single-digit range. This reflects a reallocation of cost and efficiency initiatives in MS&A as we continue to invest in our new launches. R&D expenses are expected to be largely in line with last year due to our dynamic portfolio of studies reading out and new study starts. We project our tax rate to be approximately 17%, reflecting changes to Puerto Rico tax laws and product mix. Finally, we expect to grow our non-GAAP earnings per share. with a range of $7.95 to $8.25. This represents growth of approximately 5%. Excluding prior year acquired in-process R&D, adjusted EPS would grow approximately 2%. So before we move over to Q&A, I want to thank our colleagues around the world for the strong performance in 2022, our strong execution in 2022, and our commitments for 2023. reflects the resiliency of our business and the renewal of our product portfolio. The performance in the year positions us well for long-term growth. I'll now turn the call back over to Tim and Giovanni for questions and answers.
spk10: Thanks very much, David. I know it's a very busy schedule today, so we're going to get into the Q&A. If you could keep questions just to one, that would be very helpful. Dennis, can we go to the first question, please?
spk06: Yes, the first question is from the line of Chris Schott with J.P. Morgan. Please go ahead. I'm sorry, it's from the line of Jeff Meacham with Bank of America. Please go ahead.
spk07: Okay. Hi, everyone. Thanks for the question. I'll keep it to one. So on CITIC2, you know, I realize it's early days in the launch, but what are the opportunities to improve formulary positioning this year as your market share improves? And to the many biosimilars launching this year, you know, Humira, you know, as well as, you know, across the board, have an impact on any of these PBN discussions?
spk08: Thank you. Sure. Thanks for the question, Jeff. This is Chris. I'll take it. So, first, we're very happy with the performance of SoTik2. It's obviously early days, but as is reflected in the remarks that David just had, the reception for the product has been very, very good. The feedback that we're getting on the profile coming from customers is good. We now have over 2,000 scripts. As of the end of November, our market share for the oral market in moderate to severe psoriasis is roughly 35% for new products, and it's roughly 12% if you look at the overall market, and that's just after two full months of launch. So very happy with what we're seeing in terms of the momentum coming out of Q4. As it relates to whether we can accelerate the access position, I think the way we would characterize it is the base case continues to be 2024 for moving into a better access position. That said, we're doing everything we can to possibly accelerate that. We're obviously having good discussions with payers. And the strategy that we have for potentially accelerating that remains unchanged, which is continue to drive demand as quickly as possible for this product. And the good news is we have the profile and we're seeing the feedback from customers that we think will enable us to do that. As for the impact of biosimilars, obviously this is a dynamic environment. You've seen a number of movements just in the last few weeks. What I would say is that our approach to gaining access really doesn't evolve based on what we know about biosimilars. We think 2023 is going to be a transition year for biosimilars. Clearly, the strategies of companies and PBMs will continue to evolve, so it's something we'll stay on top of. But as we've said right now, certainly the strategy that we have for SoTik2 doesn't change.
spk10: Thanks, Chris. Dennis, can we go to the next question, please?
spk06: Yes, the next question is from the line of Chris Shibutani with Goldman Sachs. Please go ahead.
spk21: Great. Thank you very much. With ChemZios, that progress of rolling that out, You have previously talked about the different mix of centers of excellence, and you gave us a patient number. Can you give us a sense for what the relative distribution is of those larger centers versus perhaps maybe smaller practices? Are you seeing momentum with the setup of certifications and essentially the patient flow that you are hoping for at the pace so far?
spk08: Sure. Thanks for the question, Chris. We're seeing a nice acceleration of both patient and physician dynamics for Camxios. As I think David mentioned, we now have over 1,800 patients who have been prescribed. Importantly, we're seeing good and increasing conversion of those scripts to commercial drug. You may recall that in the third quarter, we talked about 30% of scripts had converted over to commercial drug. In Q4, that was 50%, so we're gaining momentum there. And the feedback that we're getting from The Centers of Excellence continues to be very strong. And so we've seen a nice pickup. And what I would say is that that pickup has accelerated over the course of the fourth quarter. Recall that we are targeting approximately 500 accounts nationally. Those accounts account for roughly 60% of the overall patient volume. And what we've seen over the last quarter is a nice acceleration. in the use of camsios in those accounts and importantly some of the slower accounts that we have been focused on continue to build the infrastructure necessary to get patients on therapy and so we've seen a nice acceleration with those specific accounts as well so overall we feel like we're making good progress as we exit 2022. thanks chris dennis can we go to the next question please yes the next question is from the line of chris schott with jp morgan please go ahead
spk16: Great. Thanks so much. Just to go back to SoTik2, does the mild to moderate of Tesla label represent a hurdle at all for SoTik2 as you can think about competing for frontline share? Obviously, you're seeing some now, but is that a hurdle you guys think about? And just maybe I'm going to slip a really quick second one in. Eloquist, you saw favorable growth to net most of the quarters in 2022. Does that continue in 2023, or should we think of growth this year maybe more aligned with volume growth? Thanks so much.
spk08: Sure, this is Chris. I'll take both of those. Thanks for the questions, Chris. With respect to SOTIC2, we don't see that the Tesla broader market going into the mild category has an impact on us. And in fact, what we're seeing is very strong momentum with SOTIC2 in moderate to severe patients. When we talk to customers, what we hear from them is excitement to use the product in the full spectrum of our label, which includes not only the severe patients, but importantly, those moderate patients. And if you look at the uptake that we're seeing so far, it's reflective of the fact that physicians are gonna be willing to use it really both in moderate to severe. So given the fact that we have two phase three studies that clearly show superiority across that patient population relative to Otezla, we don't see that being a particular barrier with respect to how we think about the uptake of the product. As for gross to nets for Eloquus, for 2022, as you know, we did see some favorability due to mainly the source of business and channel mix. But as you well know, this space is a very competitive space. It's heavily managed. So we don't see gross to net favorability as we look forward. There will continue to be variability across quarters. As we've talked about many times in the past, you do see late-year seasonality with a product like Eloquus and Grows2Nets. But on a forward-looking basis, we don't see favorability with Grows2Nets with this product.
spk10: Thank you. Dennis, go to the next question, please.
spk06: The next question is from the line of Seamus Fernandez with Guggenheim. Please go ahead.
spk05: Thanks for the question. So, my question actually is on IRA and the drugs that are potentially going to be selected for negotiation, you know, towards the end of this year. Just wondering how, you know, Bristol is going to manage that situation in particular. I know that you do have patent expirations that will limit the impact there. But if that is starting in 2026, given, you know, Bristol's current product portfolio, Eloquist, one of the top players there, you know, just interested to know what it is that you feel Bristol can do to temper the impact there. And then also a sort of separate but related question on IRA. You know, we're seeing these sort of free drug launches that are running for at least a full year, and maybe not purely free drug, but substantially aided. Trying to just get a better understanding, particularly for orals, it's starting to look like the life cycle there is starting to get truncated to six to seven years. I'm wondering if you feel comfortable or even confident that there'll be a better alignment of the oral incentives versus biologic incentives inside IRA as well. Thanks so much.
spk14: Thanks, Seamus. This is Giovanni. I'll take the question, and I'll ask Chris to comment on your second question about the free goods strategies. So, I think when you look at IRA, similar, to the discussion we've had before, I would say there is a lot that we still don't know. As you know, CMS is working through the procedural aspects of implementing the legislation, and of course, over the course of this year, we'll learn much more. Now, when you look at your, you know, your question about VMS, so first of all, we know that we do not see an impact from IRA until 2026, some of the government price setting starts. And you are right that it is possible that Eliquis is impacted in 2026. Of course, we need to learn more in order to understand what the degree of impact may be. I'll just remind you that while we book 100% of the revenue for Eliquis, we split, obviously, the profit with Pfizer, so in many ways, It is an important brand, but it's a smaller brand in terms of determining our earnings trajectory versus what you would think about the revenue line. Now, you know, what can we do to continue to grow the company through the execution and implementation of IRA? In many ways, it's exactly what we are doing, is advancing new medicines to the market in order to accelerate the renewal of our portfolio. When you look at 2026, given our expectations that new launch brands will be $10 to $13 billion in sales, I would say there will be a very dynamic young portfolio that will drive the company growth for the second half of the year. And of course, those products will have been launched very recently and therefore won't be a candidate to government by setting for a while. Now, the last comment that I would make is, You are right about the challenges associated with the diverging as you refer to them for the nine years, for all the 13 years for biologics. We obviously are not pleased with that because the science is going very much in terms of enabling us to deliver, to develop more small molecules. But obviously, any change there would require legislative changes. Chris, do you want to comment on the launch dynamics?
spk08: Sure. Seamus, it's an interesting question on the role that free drug programs play in light of IRAs. As I think most of you know, free drug programs are typical, particularly in markets where rebates require that you have a transition period, particularly for new products, to make their way into a more favorable access position. Now, there's a dynamic there in that those free drug programs are typically targeted to commercial payers, I mean, commercial patients and IRA, of course, is focused on Medicare. That dynamic notwithstanding, I think that you're right, though, that to the extent that free drugs and free drug programs play out for extended periods, it could have a negative impact when you look at the IRA restrictions and price setting coming in in nine years. I think what that reinforces for us, though, is the importance of very strong commercial execution because clearly what you want to do is transition from free drugs into a more favorable access position as quickly as possible. And so, as we just discussed, for a product like SOTIC2, that's going to continue to be our focus. But I think it's a very important question. It's something that we're going to have to continue to monitor as we learn more about the rollout of IRA.
spk10: Great, Dennis. Can we go to the next question, please?
spk06: The next question is from the line of Steve Scala with Cowan. Please go ahead.
spk18: Thank you very much. We noted that Bristol initiated a Milvexian SSP phase three trial with primary completion in November of 2026, and that additional phase threes will be started in the first half of this year. But Bayer's studies are expected to read out a full year earlier. Is this consistent with your perception that Bristol is a year behind Bayer? I should add that you were not first with Eloquus and ended up dominating, but let me let you answer the question. Thank you.
spk13: Thank you, Steve. Samit here. Thanks for the question. Look, we planned the studies, and we put a timeline with those studies in terms of the enrollment, and then, of course, these are event-driven trials, so we'll have to wait for the events to happen before we read out and report the results. So we have to take all of those into account. But of course, the clinical trials, we can impact them by looking at what the enrollment rates are and how these trials are enrolled. So I think what you see on clinicaltrials.gov is our guesstimate of when the trials are going to be reading out. It is possible that we might be reading out earlier. It is possible our competitors will be reading out later. But these are early days, and we'll update you as the trial progresses if the timelines do shift.
spk10: Thanks so much. Dennis, can we go to the next question, please?
spk06: Yes, the next question is from the line of Tim Anderson with Wolf Research. Please go ahead.
spk03: Thank you. A few questions back on CITIC2. Can you just quantify where you are on market access in 2023 in terms of number of lives covered? And where you do have access, are there any step edits requiring a Tesla first? And then on your bridge program, will that last all the way through 23 or will you begin to phase it out before year end?
spk08: Thanks for the question. So with respect to market access, we think we have about 10% of patients who are in plans that have open or preferred access. And obviously that's going to continue to increase as we continue to engage with payers. And as we said, our base case for a much more favorable access position writ large across the major PBMs is for 2024, but we're doing everything we can to accelerate that. As for the bridge programs, bridge programs are typical in this market, and I think we would typically think about keeping those bridge programs open until we find that we are in a position where we've got the volume to negotiate a much faster access or more favorable access with the big PDMs. The nice thing that we're seeing, Tim, with SOTIC2 is that the vast majority of patients are going into our hub. What that enables us to do is monitor the status of those patients with respect to formulary positioning. And so even if that bridge program is open, we have the ability to transition those patients to commercial drug the moment we certify that their plans are able to take them on commercial drug. And so it's a more dynamic process than might be indicated just in the discussions that we've had. In fact, we have the ability to look at this on a more real-time basis, but we do anticipate that those bridge programs will remain open, certainly as we get into 2024. Thanks, Chris.
spk10: Can we go to the next question, please?
spk06: The next question is from the line of Evan Segerman with BMO Capital Markets. Please go ahead.
spk22: Hi, guys. Thank you so much for taking the question. You know, Ana Bekma, you went from kind of struggling to meet patient demand in early 2022 to now expanding into earlier lines of therapy. Now, how should we think about bridging this gap? Really, you know, I'm talking about expanding capacity and when we could potentially see more slots come along for both your cell therapies. Thank you.
spk08: Yeah, Evan, maybe I'll take that one. This is Chris. So we're actually quite happy with the capacity that we continue to, and actually we saw with both products in the fourth quarter. You may recall that for Breonzi, we had anticipated the expansion of capacity would wait until we got into this year. We were very happy to see that expansion be accelerated into Q4. So, you know, I think that as we look forward to this year, we continue to see an expansion of capacity for both cell products, cell therapy products, and that's certainly true with Abecma. And I would say the other thing to keep in mind is we've thought about manufacturing, which is going to continue to be an area of focus for us for cell therapy, is we have a three-fold strategy. First, we continue to stay focused on manufacturing success rates. That's one of the more important elements that, frankly, affect all cell therapy products. These are complex products. drugs, they're living products and you have to stay focused on your manufacturing success rate. Second, we've talked at length about vector supply and we obviously have a number of strategies in play from dual sourcing to increasing the number of suites and ultimately switching to a next generation suspension vector on that front. And then finally, drug product. And there it's mainly about bringing additional manufacturing sites online and we've discussed previously our efforts in Devons, Massachusetts and Leiden to do just that. So what I would say sort of leveling it up is that manufacturing has to continue to be an area of focus for us. We've got good strategies in place and we've seen those strategies play out with expanded capacity, not only in Q4, but we anticipate through the remainder of this year.
spk10: Thanks, Chris. Can we go to the next question, please, Dennis?
spk06: The next question is from the line of Terrence Flynn with Morgan Stanley. Please go ahead.
spk01: Great. Thanks for taking that question. David, probably for you, just thinking about the guidance, OPEX, you've got a low single-digit decline this year, which offsets some of the gross margin pressure. And R&D, you're holding flat, so it looks like most of the decline is going to come on the SG&A side. So just as we look into 2024, I guess we're anticipating additional gross margin pressure given, you know, Revlimid rolling off. more fully, how should we think about expenses and margins as we think about the cadence into 24? Thank you.
spk17: Terrence, thank you for the question. And you're right as it relates to gross margins. We do anticipate them coming down. And last year was in line with expectations as what we're guiding this year at that 77% due to that product mix as revenue declines. As far as OPEX is concerned, we continue to find efficiencies, operational efficiencies. We learned a lot through COVID with digital technologies, particularly on how we're engaging with healthcare professionals, but also on top of that, reallocating resources from the mature brands to our launch products, making sure they're fully funded. We've been able to do that very effectively. From an R&D perspective, you may recall, as we talked about the levels of R&D spend, it's really driven by our portfolio. That has the single biggest impact on the level of R&D spend, and we just launched nine new products, so we had many late-stage programs coming offline. We have some new ones coming online, but some of those are through partnerships, I think. Well, Vexion's a great example of that, where we have several phase three programs that are gonna be beginning, but those costs are shared with our partners. So that's why we believe, as we look at our business this year, a low single-digit decline in our overall operating expenses is what we're anticipating. But we feel very confident, even with the step-down in gross margin, as we look at our base, continue to grow the top line faster than our expense base, that gives us the flexibility to maintain those operating margins above 40%.
spk10: Thanks, David. Can we go to the next question, please, Dennis?
spk06: The next question is from the line of Mohit Bansal with Wells Fargo. Please go ahead.
spk11: Thanks for taking my question. Maybe if I may ask a little bit more on the guidance side. So from our map, it looks like for inline products, you are looking at another really good year. So after like 11% growth, we calculate, you're expecting about 8% growth again this year, which seems to be the delta between you and consensus. So could you please talk a little bit about puts and takes there? And where do you see the most robust growth in that inline portfolio? considering Eloquist OUS challenges there as well.
spk14: Thank you.
spk17: Yes, well, thank you for the question, and you're right. We do see multiple drivers for our growth in 23. As I said, overall, 2% growth with our inline and new product portfolio offsetting the declines in our enravelment and the LOEs. And that's really coming across, you know, as we think about the inline, and as we talked about before, you know, we had really strong double-digit growth on Eloquist this past year. We continue to see growth despite some of the headwinds that we see in Europe. Good, strong growth in the U.S. And Opdivo Urovoi with our additional tumor indications and adjuvant setting. We continue to see good growth in lung as well as in gastric cancers and continue to see very strong growth continuing on our IO franchise. And then the new products, remember, that's a significant growth driver. As I talked about in my earlier remarks, And that doubled last year. And as we said, we see that continuing into this year. So between the inline business, as well as that new product momentum that we have as we exited last year and the guidance we're providing this year, we have multiple ways to continue to grow. And we're very confident in our ability to do that this year.
spk10: All right, Dennis, can we go to the next question, please?
spk06: Your next question is from the line of Carter Gold with Barclays. Please go ahead.
spk19: Great. Good morning. Thanks for taking the questions. Maybe focus on one of those launch products with Rebelazil here. You alluded to some duration growths. Would love any additional color you can provide there. And then as you think about commands, how should we think about the stage gates to filing and when we might see that data presented? Is that something we might have to wait to, say, late June for, or is there the opportunity to potentially share that data ahead of then? Thank you.
spk08: Yeah, maybe I'll start and then switch it over to Sumit for your questions on commands. So with respect to Reblazil, yeah, we continue to see good acquisition of new patients on Reblazil coming out of the fourth quarter, and certainly we would expect to see that continue into this year. But as you note, where we see the potential for the most significant growth with this product is really first, is increasing dosing and administration and ensuring that we've got the right titration of patients. We have seen some improvements in that regard over the last year. In fact, duration of therapy is up 6% in 2022 versus 2021, and we would expect to continue to see, particularly as patients titrate up over time consistent with the MEDALIS study, that that duration of therapy would continue to increase this year. And then the second big area of focus that we have is getting those patients who are no longer responding to ESAs in the first line setting to move on to Revlozil. That's been a big area of focus for us. And again, here too, we've made good progress. The time on ESAs has decreased since our approval from roughly 18 months to now roughly 11 months. And so those are the two big dimensions that we have. as a focus in 2023. And then obviously the command study provides the next large catalyst for growth. And we think that that indication will roughly double the opportunity that we have with Reblazil. But in terms of timing, I think Samit can speak to that.
spk13: Thank you, Chris. And thanks, Carter, for the question as well. So we don't have the specifics of the conference right now where we will be able to share the data, but certainly we will confirm that as information becomes available. In terms of the filing, again, we do not comment on that until we have, we release, we do a press release after the file is accepted. But certainly, please, with the data, as Chris just mentioned, COMMANDS is an important study for moving our to the front line, where we compared against an active control of ESA and shown the superiority.
spk10: Can we go to the next question, please, Dennis?
spk06: The next question is from the line of Matt Phipps with William Blair. Please go ahead.
spk04: Well, thanks for taking the question. You noted in the slides the decision not to move syndacumab into forward in atopic derm. Is that something specific from the product profile in the phase two? That could maybe read through to the ongoing EOE trial, or is it just the competitive dynamics in atopic dermatitis?
spk13: Yeah, sure, Matt. I can take that question. Summit here. Thank you for that. Look, remember, we have always said that as we move our programs forward, we always look at the data and want to see the differentiation of that data. And then, of course, look at the landscape and the competitive dynamics as well. In atopic dermatitis, there are several therapies that have recently become available for patients, and they're very effective. And so we had set our threshold quite high in terms of making that difference for the patients for atopic dermatitis. So we have seen the data. We do meet the primary endpoint, but we don't think that it has a competitive advantage over what is available to the patients at this time. And therefore, we're not moving it to the registration trials. But it has nothing to do with what we saw for Sildacumab in eosinophilic esophagitis, where we not only saw a change in the eosinophil infiltration, but also the dynamics in terms of the outcomes of patients for their dysphagia as well as the fibrosis in the Phase II study. And so that study continues and certainly will share the results when the study is completed.
spk10: Thanks so much. Can we go to the next one, please, Dennis?
spk06: Your next question is from the line of Robin Kornowskis with Truist Securities. Please go ahead.
spk12: Great.
spk06: Thank you for the question.
spk12: So you have PIC2 and lupus. subject to in lupus, there's going to be a phase three reading out with Pfizer and JAK plus TIK2 later this year. Maybe frame it on if that trial fails, like what's your thoughts on the biology and how you'll think about potential success with your TIK2. And then a flip question, you know, if it succeeds, how do we think about from the biology standpoint, if you know anything about how much value adding JAK on top of a TIK2 might be for lupus? I know it could influence the safety profile, but anything you could give us on efficacy would be great. Thanks.
spk13: Maybe I can take that again. This is . Thank you for the question. If you think about it, today there is no JAK inhibitor approved for treatment of patients with psoriasis. We demonstrated the benefits of a TIK2 inhibitor, which has very specific downstream effects on IL-12, IL-23, and interferon, which, of course, is important. And throughout the last year, or maybe even more, We've been answering that question of differentiation and protecting from a safety perspective the profile of a TIK2 inhibitor versus a JAK inhibitor. So if you just move that fast forward now and think about it, that for a patient population for whom we just shown a superiority versus the prior standard of care that will be used in the oral setting, we've shown two trials with that superiority. We've got the data in the phase two setting for psoriatic arthritis as well as SLE, and we are in the phase three clinical trials for all of these indications. So I think the profile of SOTIC2 is well set now, I think, and the confidence that we have on that data and the evolution of that data is making it very promising for physicians to prescribe it, as Chris talked about earlier. So we will rely on that information and the evolution of the data for our own molecule. I cannot speak to what Pfizer will do when their data reads out. But certainly, I'm pretty sure you will all be asking the question, is a JAK inhibitor the right thing to do in psoriasis when there are efficacious safe therapies available for these patients?
spk10: Thanks so much. Can we go to the next question, please, Dennis?
spk06: The next question is from the line of Olivia Breyer with Cancer Fitzgerald. Please go ahead.
spk00: Hey, good morning, guys. Thanks for the question. Chris, maybe one for you. Is there any update on Revell mid-sales expectations looking beyond this year? I know you've talked about a $2 billion-plus annual decrease in the past, but any changes to your thinking with respect to the revenue run rate there? And then a quick clarifying question on SOCHIC2. Where are you guys at with the high-dose program, and could we see that move into any indications beyond UC at some point? Thank you.
spk17: Great. Hi, Olivia. It's David Elkins here. I'll take the Revlimid one. Yeah, nothing has really changed in our outlook for Revlimid through 2025. You know, we provide our update for this year, that $6.5 billion, which is a $3.5 billion step down, given the better performance last year in 2022. As we think about 2024 and 2025, on average, about a $2.5 billion step down is how we're thinking about it. Chris or Sumit?
spk13: Actually, yeah, thank you, David. Certainly, SOTIC2 has two studies in IBD that are ongoing, one of them using a higher dose in ulcerative colitis. If you recall, we do not have a proof of concept in ulcerative colitis or IBD at this time, and one of the hypotheses that we want to test is the higher dose of SOTIC2 in IBD or specifically over here in ulcerative colitis. We are looking forward to seeing the data in the latter part of this year. And dependent on that data, dependent on outcome, then we'll be able to formulate the strategies as to how to move forward in IBD and or other indications at the higher dose. You recall, though, that we've also tested higher doses in previous trials and other indications, and our safety profile has been maintained in those clinical trials. So we're not necessarily looking forward to any major signals that could arise in the higher dose, but certainly looking for the efficacy signals.
spk10: Thanks, Amit. Can we go to the next one, please, Dennis?
spk06: The next question is from the line of Andrew Baum with Citi. Please go ahead.
spk20: Thank you. A couple of questions on your LPAR1 antagonist. Can you just remind us when we might see that Phase II data? And also, given the failure of Roche's Pentrax from today, how are you thinking about the Phase III trial design? And then finally, what other fibrotic indications aside from IPF are you looking at for that drug? Thank you.
spk13: Thank you, Andrew. So LTA1, certainly we're looking forward to presentation of the data within this year, within the first half of this year. And certainly as soon as we have confirmation on the conference, we will be able to share that information. We did see the news from the competitor program, as you're referring to Roche, that the phase three trial was stopped. We do see that our data, the phase two data that we've seen thus far are very strong. We've talked about the patient population. with no background standard of care as well as in combination with the background standard of care therapies. And we are pleased with what we've seen. We are in discussions on the appropriateness of the clinical trial design with the regulatory authorities. And you will get to see that as we launch that and as we make that public. So more to follow on that in appropriate time to come. But really pleased with that. And the last question that you had on the additional progress programs, we're looking at LPA1 from two perspectives right now. One is the IPS program, and the other one is the progressive pulmonary fibrosis. But that Phase II data is going to be reading out later this year, so we're looking at those two things for now. Thank you.
spk10: I think we're running short on time. Maybe we can go to our last question, please, Dennis.
spk06: Today's final question will come from the line of Colin Bristow with UBS. Please go ahead.
spk02: Hey, good morning, and thanks for squeezing me in. Maybe just a couple of very quick pipeline questions. I see you have another TIK2 inhibitor in Phase I. Could you just give us any color on this, Asghar, and how you'd anticipate it differentiating versus the TIC2? And then just another one on 207, you recently terminated phase one development in non-small cell. This is one of your anti-TIGES. I think you cited safety issues. I was just wondering if you could specifically say what these issues were. Thank you.
spk13: Sure. Thank you. In terms of your first question around the phase one that is ongoing with the next TIK2 inhibitor, in general, we always have one or two programs that we look at in terms of having the next generation of molecules in development. And so this is just phases of development of general pipeline that we have additional TIK2 inhibitor. We also have a TNF penetrant TIK2 inhibitor that is in phase one. So there is nothing special. at this time to talk about, but certainly as the data arises, as the data evolves, we will be able to share those data in the future. For the TIGIC program, remember, this is a trial that was being conducted in patients with non-small cell lung cancer looking at a combination with nivolumab and ipilimumab. And what we have seen thus far, I'm not going into the specifics because those data will be presented at some future conference, but We do see that there is toxicity that is observed when combined with dual IO therapy for this particular . And so more data to come as we get more insights and more specifics on that, and then the presentations will be done. But because of those safety reasons, we have decided to terminate this particular trial at this time. Thank you.
spk14: Thank you, Samit. And thanks to all of you for your participation. As you've seen, it's an exciting time for the company. We have another important year ahead, lots of things to talk about, but we know it's a very busy morning for all of you, so we're going to end the call here. And as always, please reach out to our team if you have any additional questions. So thanks, everyone, and have a great day. Thank you.
spk06: This does include the Bristol-Myers Squibb Fourth Quarter 2022 Earnings Conference Call. Thank you for your participation. You may now disconnect.
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