Q1 2025 Bristol Myers Squibb Co Earnings Call
Speaker Change: Good day and welcome to the Bristol Myers Squibb, first quarter, 2025 earnings conference call. Thank you very much for your time.
Speaker Change: All participants will be in a listen only mode. Should you need assistance, please signal conference specialist by pressing the star key followed by zero. After today's presentation there will be an opportunity to ask questions.
Speaker Change: Senior Vice President and Head of Investor Relations. Please go ahead, sir. Thank you.
Speaker Change: Thank you, and good morning everyone. We appreciate you joining our first quarter 2025 earnings call.
Speaker Change: 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 Summit Hirawat, our Chief Medical Officer and Head of Global Drug Development. Thank you very much.
Speaker Change: Earlier this morning, we posted our quarterly slide presentation to BMS.com that you can use to follow along with Chris and David's remarks. Before we get started, I'll remind everybody that during this call we will make statements about the company's future plans and prospects that constitute forward-looking statements.
Speaker Change: Actual results may differ materially from those indicated by those forward-looking statements as a result of various important factors including those discussed in the company's SEC filings.
Speaker Change: 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, and 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.
Speaker Change: Reconciliation of certain non-GAAP financial measures to the most comparable GAAP measures are available at BMS.com
Speaker Change: Finally, unless otherwise stated, all comparisons are made from the same period in 2024 and sales growth rates will be discussed on an underlying basis which excludes the impact of foreign exchange.
All references to our P&L are on a non-GAAP basis. This is our P&L.
and with that, I'll hand it over to Chris.
Chris Boerner: Thanks, Chuck, good morning, and thank you all for joining our first quarter earnings call. We do strong Q1 driven by solid execution across the business and continued focus on our strategic priorities. Thank you all for joining our first quarter earnings call.
Chris Boerner: Maximizing our growth portfolio, accelerating our R&D pipeline, driving operational excellence, and strategically allocating capital. Our plans to transition the portfolio to deliver long-term sustainable growth are underway.
Chris Boerner: Today, I will begin with some comments on our first quarter performance and highlight our recent accomplishments. Then, I will discuss our pipeline and upcoming catalyst that can further strengthen our long-term growth potential. I'll end by addressing the current operating climate. Starting with performance on slide four, our growth portfolio again delivered double-digit sales growth driven primarily by strength in key marketer products including our IO portfolio, Brianzi, Rebelsil, and Kim Zayos.
Chris Boerner: And as expected, our legacy portfolio performance primarily reflected the impact of generic entries for certain older brands. [inaudible]
Chris Boerner: So turning back to our growth portfolio, let me speak to our recent launches. Thank you very much.
Chris Boerner: As you'll recall in October , we launched Kobinfe, the first truly novel mechanism for the treatment of schizophrenia in decades, and we are pleased with the early prescription trends. Patient and physician feedback is very positive, reflecting its favorable tolerability and efficacy profile, and noting that patients are observing cognitive benefits.
Chris Boerner: In January , we launched Avdivo Cuvanti, the subcutaneous formulation of Nevilleumab, which is also receiving promising early feedback from practices and patients.
Speaker Change: And based on our performance in the first quarter, we are increasing our top and bottom line guidance. David will provide more detail shortly. We continue to advance our pipeline during the quarter with several recent announcements. Updivo Plus Your Avoid received FDA and EMA approvals for the treatment of first line liver cancer and FDA approval for use in MSI high colorectal cancer in the U.S. [inaudible]
Speaker Change: Further solidifying its leadership in Immunal Oncology, Rihansi was approved in the EU for Treatment of Fulicular Lymphoma, expanding our self-aerope presence in blood cancers.
Speaker Change: Kim Zayos received approval in Japan and a favorable label update in the US.
Speaker Change: which reduces the REMS Echo Monitoring requirement in the maintenance phase. In addition, Millvexian reached an important milestone in the quarter. With the completion of enrollment in the La Brexia atrial fibrillation trial, this event-driven study remains on track to read out in 2027.
Speaker Change: Turning to Slide 5 and our two recent top line readouts.
Speaker Change: While we're disappointed that the Kimzaios Odyssey study and non-obstructive HCM and the Kobin-Fee Arise study in adjunctive schizophrenia did not meet their primary endpoints, I want to put the results in proper context.
Speaker Change: Although these are not the results that we had hoped for, neither outcome, meaning we altars our strategy or growth trajectory. This is the end of the video.
Speaker Change: For Ken Zayos, the study strongly suggests that non-obstructive and obstructive HCM behave distinctly.
Speaker Change: We do not expect these data to significantly impact peak sales, and our focus remains on our existing obstructive HCM indication which represents the vast majority of the market opportunity. For COVID-19, although it did not demonstrate a statistically significant improvement as an adjunctive treatment in the Arise trial, these data are encouraging. Thank you.
Speaker Change: showing a noteworthy improvement for the majority of patients as well as a tolerable safety profile. As we noted earlier this week, we will complete a full evaluation of the Phase 3 trial data and will plan to engage with the medical community and regulators to discuss these results and potential next steps.
Speaker Change: Also, it's important to remember, there are no currently approved adjunctive therapies for schizophrenia. Our commercial strategy remains focused on monotherapy which accounts for 70% to 80% of the market, where our goal is for Kobinfi to become the foundational treatment. As I mentioned earlier, Kobinfi's differentiated profile is resonating, and we're seeing strong early update. Looking ahead, we're confident in the strength of our portfolio and the breadth of opportunities in our pipeline.
We expect several of these opportunities to come this year.
Speaker Change: such as the first look at one of the phase three trials for a COVID-19 and Alzheimer's disease psychosis, where there is significant unmet knee. We also plan to initiate several new pivotal studies this year, including seven phase three studies for COVID-19 across three indications, Alzheimer's agitation, Alzheimer's cognition impairment, and bipolar one, all expected to be underway by mid-year. At the same time in oncology, we're advancing two next wave solid tumor programs.
Speaker Change: First, R-E-G-F-R, Fur-3, Antibody Drug Conjugate, Isaac Brenn, is expected to begin enrollment in a pivotal study in first line triple negative breast cancer in the coming months.
Speaker Change: Our commitment to innovating for patients remains strong, as we advance first and or best in class medicines, full through internal discovery and business development, which remains a top priority. In terms of BD, we're actively pursuing opportunities that can enhance our growth profile where they're strong strategic alignment and financial rationale. With our renewed organizational agility and balance sheet in a solid position, we have the flexibility to act decisively when we find the right opportunities.
Speaker Change: As we've said, maximizing long-term growth starts with strong execution this year and over the midterm. The growth portfolio is performing well and our pipeline is advancing. At the same time, we're taking deliberate actions to rightsize our cost structure and become a more efficient company. Overall, I'm confident we will deliver on disciplined execution as we position the company for top-tier growth by the end of the decade. The growth portfolio is a more efficient company. The growth portfolio is a more efficient company. The growth portfolio is a more efficient company.
Speaker Change: a potential economic downturn or restructuring at the FDA and HHS. This backdrop notwithstanding, our focus continues to be on building a strong and resilient company that can navigate and manage through operating complexities. [inaudible]
Speaker Change: We remain confident in our ability to deliver for our patients' employees and shareholders.
Speaker Change: Our strategy is clear, and we're executing. We have a rich pipeline with strong growth potential. We act swiftly when we see opportunities, whether it's business development to bring in great science or pursuing efficiencies in our business. [inaudible]
Speaker Change: And finally, we are laser focused on execution, as you can see by our strong performance this quarter. With that, I'll turn it over to David.
David Elkins: Thank you, Chris, and good morning, everyone. Our performance in 2025 is off to a strong start. We are executing our growth strategy in terms of driving revenue for key products, while also right sizing our cost structure. Our persistent focus on execution is strengthening our foundation and positioning the company deliver long-term sustainable growth.
David Elkins: This morning, I'll provide highlights of our performance in the first quarter and then review our outlook for the year.
Now turning to the first quarter on slide seven.
David Elkins: Total company revenues were approximately $11.2 billion, reflecting strong demand across our growth portfolio, including the launch of Coventy, offset by the impact of generics and Medicare Part D redesign, primarily in our legacy portfolio. Global sales of the growth portfolio increased to approximately 18%. Led by key brands, including our IO portfolio, Brianzi, Rebozel, and Kim Zias.
David Elkins: Turning the key product performance on slide 8, Adivo had a solid first quarter, with global revenue up 12%, driven primarily by volume growth.
David Elkins: Separately, initial sales of Optiva Cuvante were approximately $9 million in the quarter. The US launch is progressing well. With early adoption across multiple tumor types, we continue to believe that physicians will convert approximately 30-40% of patients to this new product.
David Elkins: Let's turn to hematology on slide 9. Rebel Cell Global Sales Reflected Continued Strengths Across First and Second Line MDS Associated in Nemia. Higher sales in the US were related to increased use in first line setting. Outside of the US, Rebel Cell's strong double digit sales growth was driven by demand across newly launched markets in Europe and Japan.
David Elkins: In South Therapy, Briandi was another key contributor to our strong growth portfolio performance in the quarter, driven by demand across all indications. US sales more than doubled and international sales tripled. Moving to cardiovascular on slide 10, let's start with Kim Zayas.
Kim Zayas: Sales in the first quarter nearly doubled, benefiting from strong global demand. Bram Amendment in the quarter was driven by new patient starts and a 19% increase in total prescriptions for the three months ended March 31st.
Kim Zayas: We continue to expect study growth of Kempzias in 2025 due to its compelling efficacy and safety profile on obstructive HCM.
Kim Zayas: Turning to Eliclis, Global Sales are down 3% and 1.25, mainly due to the impact of Medicare Part D redesign in the US.
Kim Zayas: We continue to expect total eloquent revenue to be stronger in the second half of the year, primarily due to Part D redesign and elimination of the coverage gap. Moving to immunology on slide 11, across our immunology portfolio, we saw higher commercial rebates as previously discussed. Dr. Prasad, Dr. Prasad, Dr. Prasad,
Kim Zayas: Now moving to slide 12, in its first full quarter on the market, Coventy is off to a solid start with sales of approximately 27 million dollars driven primarily by demand. During the quarter, weekly total prescriptions remain strong, tracking ahead of all branded schizophrenia launch benchmarks.
Kim Zayas: Now let's move to the P&L on slide 13. Gross Margin was approximately 73% primary due to product mix. Offering expenses were more than $500 million lower compared to the same period last year, primarily reflecting the results of a strategic productivity initiative.
Kim Zayas: Our effective tax rate in the quarter was 15.1%, primarily driven by earnings mix, an overall diluted earnings per share, or a dollar 80.
Kim Zayas: Turning to the balance sheet in Kapo location highlights on slide 14, our financial position remains strong with approximately $12.1 billion in cash equivalents and marketable securities as of March 31st.
Kim Zayas: We generate a cashflow from operations of approximately $2 billion in the first quarter. In terms of capital allocation, we maintain our strategic and balanced approach.
Chris Boerner: As Chris highlighted earlier, business development remains a top priority, and we continue to actively assess opportunities in line with our strategy, and we remain on track with our plan to pay down $10 billion of debt relative to our March 31st, 2024 balance. Thank you very much.
A couple of allocations also include rewarding shareholders to the dividend.
Chris Boerner: 2025 marks our 93rd consecutive year of dividend payments. In addition to strategically allocating capital, we are also driving operational excellence to our previously announced strategic productivity initiative. With respect to our 2025 expansion, we expect to realize approximately $2 billion in annual cost savings by the end of 2027, and we remain on track to deliver $1 billion of these savings by the end of this year. [inaudible]
Chris Boerner: Now turning to our outlook, starting with revenue on slide 15.
Chris Boerner: We are increasing our full-year revenue guidance to a range of approximately 45.8 billion to 46.8 billion dollars, reflecting strong performance of our growth portfolio, better than expected legacy sales in the first quarter, and a favorable impact of approximately 500 million dollars related to foreign exchange rates relative to our previous 2025 guidance. We are increasing our full-year revenue guidance to a range of 500 million dollars related to foreign exchange rates relative to our previous 2025 guidance.
Chris Boerner: Additionally, we now expect legacy portfolio to decline approximately 16-18% for the year. A more moderate rate and previously anticipated do primarily to revim its strong Q1 performance.
Chris Boerner: We now project full-year sales of Revenant to be at the top end of our previously-guided range. Thank you.
Chris Boerner: Expenses are now anticipated to be higher in the second half of the year compared to the first half, reflecting timing of investments. [inaudible]
Chris Boerner: For OINE, we now expect annual income of approximately 100 million due to higher than anticipated royalties and favorable interest income. Although the first quarter tax rate was slightly lower than our full-year projection, we were maintaining our full-year tax rate guidance of 18%. As a result of these changes, we are raising the midpoint of our 2025 non-GAPEPS guidance by 15 cents per share, with an expected range between $6.70 and $7.00.
Chris Boerner: A revised guidance includes the SMA impact of current tariffs on US product shipped to China, but does not account for any potential pharmaceutical sector tariffs. [inaudible]
Chris Boerner: In summary, our strong performance in the first quarter reflects our focus on disciplined execution. We are well positioned to manage the near-term uncertainty in the macro environment, while advancing our long-term growth strategy.
Chuck: And with that, I'll now turn the call over to Chuck for Q&A.
Chuck: Thank you. We will now begin the question and answer session.
Speaker Change: To ask a question, you may press star than one on your telephone keypad. If you're using a speaker phone, please pick up your handset before pressing the keys. And to if you are your question, please press star than two. And at this time, we'll pause momentarily to assemble our roster. Thank you very much.
Unknown Executive, Christopher Boerner, Chuck Triano
Drone, Drone, Drone, Drone
Speaker Change: And the first question will come from Chris Schott with JP Morgan. Please go ahead. Thank you very much.
Speaker Change: Great, thanks so much. Maybe just two ones for me, just the first bigger picture, as we think about tariffs and the 232 stuff that's going on right now. Can you just provide any color on the company's U.S. manufacturing footprint, ability to shift manufacturing to the U.S. over time, just in general, you're able to navigate this dynamic. I know the details are lacking right now, but just...
Speaker Change: Maybe you just help frame out how you're thinking about this. And the second question for me was on Kobenfi, just in light of the adjunctive results we saw. Just talk a little bit about what this does for your outlook on Kobenfi and just how you think about kind of use in adjunctive given the negative trial results we saw. Thanks so much.
Speaker Change: So thanks for the questions, Chris. I will start with your tariff question and I'll turn it over to Adam to address. Thank you for your time.
Speaker Change: Co-Ben Fee, so first, let me just say at the outset that we certainly appreciate the administration's efforts to enhance. Thank you very much.
Speaker Change: And as you can appreciate, there's a lot that we don't know here. We don't have specifics on the outcome of this investigation. But our hope is that wherever this lands, we ultimately end up enhancing the competitive
We are a significantly U.S. based company today.
Speaker Change: We have been up investing in core infrastructure in the US for many years. [inaudible]
Speaker Change: So we need to ensure that ultimately our trade policies enhance. Thanks.
Speaker Change: DeSector and Support Efforts like the ones we've been making in terms of our exposure. Again, what we've said is the...
Speaker Change: Terence that have gone into place, namely around China, have been reflected in the guidance that we provided today. It really is simply too early to provide a lot more on pharma specific sectors, so we'll have to wait for the specifics there and once we have them obviously we'll continue to update you. . . .
Speaker Change: Recall, about 70-80% of patients are treated with monotherapy, and clearly that's the most significant commercial opportunity, and it's also the treatment goal for psychiatrists. [inaudible]
Speaker Change: What happens in the real world? Like, I just exhaust monetary options before trying adjunctive use. And that's after several failed monetary treatments happening later in line. Third line, fourth line plus. [inaudible]
Speaker Change: Our focus is moving Coventry earlier in treatment. That's exactly what we've been seeing in the market. In fact, roughly 40 to 50% of the Coventry prescribing today is now in second line and third line. [inaudible]
Speaker Change: And so physicians have also told us both in research and through advisory boards that missing the endpoint of the study would have no impact on monotherapy usage or their willingness to use coventry particularly when you look at the safety of the study results. Thank you very much.
Speaker Change: There's a significant unmet need that still exists for patients with schizophrenia and Coventry builds a need with its advocacy and safety profile. And that's why we're seeing strong uptake in the market since launch with positive feedback from both positions and for patients. So we're going to continue to execute our plan. Thank you very much.
Speaker Change: for Coventry to come to the foundational monetary treatment, and we have a clear opportunity to continue to derive significant growth.
Speaker Change: The next question will come from Mohit Bansal with Wells Fargo. Please go ahead.
Mohit Bansal: Great, thank you very much for taking my question. So, Chris, a big picture question for you. I mean, given that, I mean, there has been a lot of cost, rationalization over a period of last couple of years.
Mohit Bansal: How are you thinking about R&D here? I mean, again, there have been a couple of statbacks here with Melanoma and all, but as going forward, I mean, when you think about taking bat, I mean...
Is there a change in the part process? [inaudible]
How are you thinking about?
The future pipeline and the riskiness of it. Thank you.
Speaker Change: Well, let me say a few things and then obviously just given the focus on R&D summit you can certainly weigh in here.
Mohit Bansal: As you noted, we've been spending a lot of time over the last 18 months focused on a few key things.
Mohit Bansal: First, making sure we're driving strong execution, that's strong execution in commercial, but really across the enterprise, and I think you see, you've seen the fruits of those efforts in terms of our performance last year and continuing in the Q1 performance.
Mohit Bansal: Second, as you know, we've spent a lot of time focusing on making the organization more efficient and more agile that was reflected in the cost optimization efforts we had last year as well as in the $2 billion initiative that we announced in our Q4 call. Thank you very much.
and then third. Third.
Mohit Bansal: Driving additional productivity coming out of R&D, and importantly delivering on the swath of new opportunities we have coming out of our mid to late stage pipeline. And that's going to continue to be a focus. And as I step back and look at the opportunities for the company, the components that I have that we can deliver on the growth ambitions for the company, in part driven by our internal R&D pipeline remains absolutely unchanged. It's important to keep in mind that while the two studies that
Red out over the last couple of weeks. [inaudible]
Mohit Bansal: We're certainly not the results that we had hoped for. As we said in our prepared remarks they have no financial. [inaudible]
Mohit Bansal: or Modest Financial Impact on the company and no impact on the prospects for growth coming out of the decade. And so we're going to continue to stay focused on delivering against that pipeline. We're going to continue to invest in strong areas of science where we have the opportunity to add significant value and we can deliver on our mission for patients and for shareholders. And also keep in mind that
Mohit Bansal: We are in a very strong financial position, that financial position gives us a lot of strategic flexibility to continue to source innovation externally, which will also be very much focused on from a capital allocation standpoint. [inaudible]
Mohit Bansal: We've had 43 major approvals since that time, so that speaks very loudly of the productivity of this organization and this is in the top quartile, 90th percentile actually, if you look across the industry from a KMR data perspective.
Mohit Bansal: Certainly the three setbacks that you talked about are very notable that we've taken into account from an R&D perspective. We learn from these.
Mohit Bansal: But what it does is now we have to look forward as the vision has already been created looking forward to 10 plus new molecular entities that we want to bring forward by the end of the decade and 30 plus new indications that we have planned for by the end of the decade. [inaudible]
Mohit Bansal: and they will start reading out now and we just started early yes. [inaudible]
Mohit Bansal: and then in 2026 there's a slew of readouts for new molecular entities so we are well planned for that one and looking forward to just growing the portfolio from there on. Thank you very much.
Thanks, Summit. Let's move to our next question, please.
Mohit Bansal: The next question will come from Luisa Hector with Berenberg. Please go ahead. Thank you very much.
Louisa Hector: Thank you. Maybe it's another question on co-pensing. Just wondering how the readout from a rise impacts your levels of confidence in Alzheimer's, psychosis, readout, and patch any additional trial to it that you may be planning.
Thank you.
Speaker Change: Thanks Luis El, I'll ask Samit to take that. Yeah, thanks Luis, some other question. Arise, data has no impact as we think about Alzheimer's disease psychosis.
Speaker Change: There are a few reasons to add one. Obviously the disease is very different too. As I'm a disease overall plan in psychosis as well as future looking cognition impairment and agitation. Those are based on the data that have already been generated many years ago, a couple decades ago. [inaudible]
Speaker Change: for the normal lane where it showed statistically significant benefits in the behavioral patterns in patients with Alzheimer's disease.
Speaker Change: Also from a design perspective, in Alzheimer's these psychosis, there's a longer duration of treatment of up to 12 weeks. [inaudible]
Chris Boerner: which is obviously going to be beneficial as we think about observation of output for primary and secondary endpoints. So overall, confident in the conduct of our studies. And as you know, we are also initiating several studies as Chris spoke about earlier seven different phase three trials this year. So really looking forward to initiation of that program. Thank you very much.
Speaker Change: Great, thank you. Let's move to our next question. The next question will come from Geoff Meacham, with City, please go ahead.
Jeff Meacham: Hey guys, good morning, thanks for the question. Chris just got a couple for you, another one on Ontario.
Speaker Change: Maybe if you could just talk about it at a high level, in the flexibility of transfer price assumptions. [inaudible]
Speaker Change: Either maybe from an IT or TAX or site of manufacturing, I wasn't sure. . . .
Speaker Change: Also about your ability to step up inventory as a potential strategy as well.
Speaker Change: and then second on BD, just given recent deals, you know, for Chinese assets but also how low valuations are across US, Smith, Biotech, you know, how do these factor in your strategy, urgency, etc. Thanks so much.
Speaker Change: Thanks for the questions, Geoff, over doing well. I will start and then I will ask David to chime in a bit on the transfer pricing component of your tariff question.
Speaker Change: Obviously, as I said earlier, we've got a lot that we still have to wait and see that comes down with respect to the impact of any pharmaceutical industry sector.
Speaker Change: Terruv's, we appreciate the fact that the administration is taking time to...
Speaker Change: Stutty, this issue, you know well, Geoff, that in this industry, our manufacturing networks are incredibly complex. Their global supply change, you have inputs coming from all over the world. There are long lead times in terms of...
Speaker Change: and certainly with respect to BMS, the medicines that we make are critical for patients and can't be easily substituted.
My having said that in anticipation of potential tariffs. [inaudible]
Speaker Change: We continue to execute mitigation efforts. We have a broad global manufacturing network where we're looking for opportunities to optimize with tariffs in mind. As I mentioned, we already have a significant presence in the US and we're continuing to invest. [inaudible]
Speaker Change: and we have already undertaken efforts to reduce risks of disruption and shortages as a result of
Epert's like Enchoring. [inaudible]
Speaker Change: And we're going to continue those efforts. We're also going to continue to engage with the administration to ensure that ultimately whatever comes down is well thought through and deliberate in terms of how we move forward. But David, anything you want to comment on?
Speaker Change: Transfer pricing, and then I'll come back to BD. So, Geoff, thanks for your question. You know, BMS, we have a really broad manufacturing network, both any US and globally, and we're not overly rely on any single country in terms of our supply chain.
Speaker Change: You know, situation related to tariffs continues to evolve and we're closely assessing we have a cross functional team in place.
Speaker Change: That's evaluating flexibility, and we have a tremendous amount of flexibility to be able to move our manufacturing around. Should any potential tears come up?
Chris Boerner: You know, as we learn more and there's more specifics obviously we'll update you when that becomes known but as Chris said previously we continue to ensure the administration as well as policymakers understand the impact of these tariffs and as well as any potential future actions both on patients as well as the industry. We'll see you in the next video.
Chris Boerner: And then, Geoff, with respect to business development, business development is our top capital allocation priority. That includes both partnerships and acquisitions.
Chris Boerner: and of course as you note, we're going to source that innovation. . . .
Chris Boerner: from wherever it comes, and there's certainly a lot of exciting innovation taking place in China. We're going to be focused on a few things though. We're going to be focused on strengthening our position in the courtiers that we operate in. That's bringing in promising areas of science, assets where we can improve the growth profile of the company. [inaudible]
Chris Boerner: Right, thanks, Chris. Next question, please. The next question will come from Evan Seigerman with BMO Capital. Please go ahead.
Evan Segerman: Hi guys, thank you so much for taking my question. I wanted to touch on the rumblings we're hearing about the potential implementation of most favored nations pricing, potentially with regard to drug price negotiation in the IRA. I guess what are you hearing and more importantly, what's your stance on how that could impact negotiations for IRA drug prices going forward? And then secondary love to touch on the potential impact, positive impact, the relaxed comedy arc, monitoring for Kim Zayas and how this could help accelerate sales.
with that franchise. Thank you so much. Thank you.
Speaker Change: Well, let me start Evan, thanks for the questions, and then I will turn it over to Adam on the second part of your question. Clearly, with respect to MFN and international reference pricing, there's a lot of focus here. I think the president and the administration is rightfully focused on the differential between US and XUS net pricing. The way we think about it is, I think you have to look at both sides of that equation. With respect to XUS net prices, we actually agree with the administration.
Speaker Change: Countries outside of the U.S. need to be allocating more health care spending to innovative medicines. So we're engaging directly with the administration, working with our pharma partners, of course, and supporting the administration's efforts here to leverage whatever tools they can to get ex-U.S. countries to allocate more of their health care spending to the types of innovative medicines that we develop at BMS.
Speaker Change: In terms of the US pricing environment, I think our perspective really is unchanged here. We have to address the complexity of the US healthcare system.
65 cents of every dollar. [inaudible]
Speaker Change: Spent on pharmaceutical products in the U.S. goes to middlemen. These are entities that don't discover, develop or deliver medicines to patients. These are entities.
Speaker Change: that because of their market power also have control over what patients pay in terms of co-pays, and there are ample opportunities to make that system more complex, and ensure that ultimately any rebates that we provide as industry are ultimately go to improve what patients ultimately have to pay for medicines.
Speaker Change: Beyond that, I would say, we continue to be focused on addressing other aspects of healthcare, notably fixing some of the more egregious aspects of IRA, the pill penalty, and addressing spillover risk on top of mine there. Of course, we continue to be very focused. [inaudible]
Speaker Change: on and concerned about abuses in the 340B program and that's going to be a big focus area of ours as well.
Speaker Change: Adam, do you want to take the second part of that question? Yeah, thanks Evan for the question, so we've continued to deliver strong growth for Cam Zio's, we've virtually double sales.
Speaker Change: versus prior year in the quarter. And our goal has been to ease the burden of echo requirements for both patients and physicians. And based on...
Rolongstrom Chronicle Data, as well as...
Speaker Change: The robust data collection, our label chain reflects the FDA's confidence in the safety and efficacy of CAMPSIOS. Now, with over 15,000 patients prescribed CAMPSIOS in the United States. So, the label has been updated to reduce the frequency of echo monitoring for patients taking CAMPSIOS from every 12 weeks, now to once every six months in the maintenance phase. And this is going to, number one, simplify processes of both patients and physicians. Thank you very much.
Speaker Change: Number two is going to open up additional capacity at the COE as a result. Positions are going to be able to treat more patients, it reduces the burden on patients and
Speaker Change: Division's time and alleviates resourcing at the series. I will say that we're just super early in the launch, but early customer feedback has been very positive since the label change and taken together we're seeing good moment for Camp Zials and we expect continued strong growth. Thank you very much.
Speaker Change: Thanks for the background, Adam. Next question please. The next question will come from Terence Flynn with Morgan Stanley . Please go ahead.
Terrence Flynn: Great. Thanks for taking the questions. I guess, maybe two for me. First on the Kobenfi lunch, Adam, I was just wondering if you could elaborate a little bit on what you're seeing with the prescriber base right now in terms of kind of breadth and depth. And then I know the slides also mentioned some one time gross to that impact in the first quarter, so just wondering if you could elaborate on that and how we should think about...
Terrence Flynn: The cadence of gross tenet over the course of the year.
Terrence Flynn: And then David was just, I know you're not going to give 2026 guidance yet at this point, but again, heard you reiterate the 37% op margin for 2025, but just, you know, directionally, how should we think about 2026 as it seems like there are still a number of moving pieces as we, as we think about next year. Thank you.
Chris Boerner: Thanks for the questions, Terence, Adam and David. Yeah, thanks, Terence. So we're very pleased with Coventry's launch performance. The launch is off to a strong start. We're now over 1600 TRXs per week and it's tracking ahead of all branded schizophrenia launch benchmarks.
Chris Boerner: We've made very good progress achieving Medicaid and Medicare access. We're now at virtually 100% access across both channels and we're making good progress with commercial payers.
Chris Boerner: I mentioned earlier that because of this access, it's allowing us to move co-vent be up earlier in treatment, which is critical.
Chris Boerner: and most importantly, we are hearing very encouraging feedback from both patients and physicians around co-bentries, efficacy and safety profile, physicians noting efficacy in positive symptoms, negative symptoms, and improvement in cognition and clarity of thought.
Chris Boerner: We're also, I think a critical metric for us is growing number of new trialists and we're seeing consistent growth week over week in new trialists since launch and we've got an opportunity to continue to expand and reach the 30,000 psychiatrists that are on our target list. Thank you very much for joining us today.
Chris Boerner: and so as we've said, we expect to see strong uptake over the course of 2025 with a ramp in the back half of the year after we continue to...
Unknown Executive, Christopher Boerner, Chuck Triano
Chris Boerner: The underlying demand for Kobenfi is strong and at launch we made assumptions around payermakes and discounts. So Q1 essentially was a chew-up for favorable growth in that from Q4.
Chris Boerner: We now have very strong access, so we expect the increases this year in gross nets for the full year. But again, we expect it to be strong uptake over the course of the year with a ramp taking place in the back half of 2020.
25.
Chris Boerner: David, great, and look, as far as 2026 we're not going to provide guidance on this call, but the way I would think about it is...
Chris Boerner: We remain very financially disciplined, you know, by the strategic productivity initiatives that we rolled out. And as we said, you know, we're well on our way this year to delivering a billion dollars in savings relating to that and on track for that two billion by 27.
Track gives us a lot of flexibility.
Chris Boerner: You know, also we continue to leverage AI and look to further automate, which is making us even more efficient, so we see greater opportunity there as well. And as we've shown in the past, you know, we're constantly looking at our portfolio and prioritizing that according, like.
Chris Boerner: So all of that being said, we feel we have a lot of levers to continue to manage this business, but at the same time Terence, we're going to invest in long-term growth of the company as well. And that's critically important to strengthen that growth position. And as we said, our cash position remains strong. We're going to invest in long-term growth, and we're going to invest in long-term growth, and we're going to invest in long-term growth.
Chris Boerner: Business Development, Main's Priority, so we look to bring in the Strength and Epifullium, bring in new assets which we'll invest behind.
David Elkins: Thanks, David. Next question, please. The next question will come from Tron Cune with UBS. Please go ahead. Thank you very much.
Trung Huyen: Hey guys, thanks for the question, just a couple of on-cam tyres from me, so one on the outside I'm a psychosis troll, just...
Trung Huyen: and then the second, just a clarification on the Kamsaias Gross-to-Net question. If you back out the Kambamfi numbers, X that one off, it looks like Gross-to-Net is 35 to 40%.
Trung Huyen: I think you just said that we should be thinking about that increasing, but you've also previously said
Trung Huyen: You should have modest discounts above Medicaid statutory rate, which is like 23%. So are we thinking that growth and their increases from 35 to 40% are you having to be more aggressive on rebates for traction?
Unknown Executive, Christopher Boerner, Chuck Triano
Speaker Change: Let me have Samit take the first part of your question, which I believe was on Kobenfi, and then the second part of your question, I'll ask Adam to take. Yes, so for Kobenfi, ADP trial, remember these are trials that are being compared to placebo, and what we have to show is statistical significance in the primary and point for NCI hallucinations and delusions.
Speaker Change: and this patient population. So, we're not pre-defining as to what the three of number needs to be to be clinically meaningful. I think over here, there are no drugs approved, so I think all improvements are good, but what we do know...
Speaker Change: from the prize studies of the normally and there have been remarkable improvements. [inaudible]
Speaker Change: Not only on these symptomatologies but also other elements such as cognition so we continue to monitor that. The data will read out for the first trial in the second half of this year so at that time we'll be able to share more. Thank you very much.
Speaker Change: Yes, relates to the growth in that. You know, we don't share a specific discounting rate, but as I mentioned, we've been very disciplined in discretionary growth in that spend.
Speaker Change: and so when you look at the growth to net impact for the first quarter, what we saw this was just a true up for a projection that we made that was favorable.
Speaker Change: in Q4. So, we will have increased in growth and net for the full year because we have now 100% access virtually in both Medicaid and Medicare. Thank you for your time.
Speaker Change: Thank you, Adam. Let's take our next question, please. The next question will come from Courtney Breen with Bernstein. Please go ahead.
Courtney Breen: Hi all, thanks for taking the question today. A couple from me, the first kind of as it relates to tariffs, we've seen a number of companies.
Courtney Breen: Come out and make statements about kind of their capital investments within the US in manufacturing and R&D kind of both.
Courtney Breen: Backward looking as well as forward looking, so I wonder if you could provide some comments on kind of Bristol's perspective there in terms of committed capital expenditure going forward. And then the second question is just. [inaudible]
Courtney Breen: As we think about kind of M&A, I know there's been a couple of questions on this so far. Thank you very much.
Speaker Change: You've also got some kind of key data cards to turn over. Milvexian, I think, is one of the big ones as well as some of these kind of subsequent covenancy trials. And so can you talk a little bit about kind of how you're approaching making that, those M&A decisions in the context of kind of internal success rates? [inaudible]
Speaker Change: and kind of waiting for sequencing of those data cards to turn over. Thank you. Thank you.
Speaker Change: Sure, I'll take both of those. So first, as I mentioned earlier, we're a company that's significantly based in the US today. If you look back over the last number of years, we've been up investing in core infrastructure that's infrastructure related to R&D, technology as well as catbacks.
Speaker Change: and we certainly have plans to continue to invest in those very same areas in the US in the coming years.
Speaker Change: So, again, what ultimately transpires with trade policies, we hope will ultimately enhance the sector and support efforts like the ones that we've been making and support the competitive of US companies.
with respect to business development, obviously business development has...
Speaker Change: Ben of priority for the company from a capital allocation standpoint for a number of years. It's going to continue to be our top allocation priority this year. If I step back and look at how we thought about business development, we really don't think about it in terms of the relationship between specific data readouts of our own internal program. It's always been a way that we've thought about sourcing new science and new innovation. And so on some.
Unknown Executive, Christopher Boerner, Chuck Triano
Speaker Change: When I look at it, I think we delivered on all of those things. So as we think about this year, there's certainly no endogenous constraints or specific events that we have to see for us to be able to execute on business development. We're going to go back to the criteria I referenced earlier. The science looks good. If it's an area that we think we can add value. And most importantly, if we believe it can enhance the growth profile for the company exiting this decade, we certainly have the financial horsepower to be able to execute it. [inaudible]
Execute quickly.
Speaker Change: Next question, let's move to the next question please. The next question will come from Tim Anderson with Bank of America, please go ahead.
Tim Anderson: Thank you for the questions. I have a question on long-term guidance, so Chris, when you took over you, kind of stopped providing those, or you guys kind of withdrew some of the elements that you had given.
Tim Anderson: Can we expect you to revisit this at some point? I know on trough guidance, you said, end of the decade.
Tim Anderson: I think the key there is the absolute level of the trough number.
Tim Anderson: So, wondering if you can assure that it won't go lower than $6 a share, that's kind of where a lot of analyst numbers bottom out.
Speaker Change: And then the second question is just transfer pricing. So, companies commonly have to be set up with major brands, not all brands, levels of disclosure. [inaudible]
Speaker Change: Next and nothing, any color you can share in which particular brands Bristol has transfer pricing arrangements in place, such that a tariffs come through in Europe that ensnare this, we have some idea of which brands might be impacted. Thank you.
David Elkins: Thanks for the questions, Tim. I'll start and then I'll turn it over to David to talk about transfer pricing. We're not going to be giving long-term guidance as a standard course. And this is what we've discussed previously. That's a philosophical point of view. Our focus is, as you know, and as we've been discussing, is to drive sustained top-tier growth as we exit the decade. We've talked at length over the last 18 months about how we're going to deliver on that. And the way we think about guidance.
as the business conditions. [inaudible]
David Elkins: Warren, with respect to trough, I think that's going to, how we talk about trough will be very aligned to that philosophy, but rest assured, the way we think about trough is we're going to do everything we can through either accelerating our internal clinical programs, continuing to engage in business development, and just executing across the enterprise to ensure that we do everything we can to shorten the depth of that trough, move it in as close as we can so that we can again return this company to sustainability.
Unknown Executive, Christopher Boerner, Chuck Triano
Speaker Change: Thanks David. Let's move to the next question operator. The next question will come from David
David Resinger: Yes, thanks very much, and thanks for all the updates. So I have two questions, first is high level, and then one is on coben fee.
Speaker Change: So, the industry is obviously facing three major government threats in the United States. Number one, actions that are harming U.S. Biopharma innovation, including HHS cuts. And...
questioning and criticism of esteemed medical scientists.
Speaker Change: Second, Tara Threats, and third, the Trump Administration's agenda to take down drug prices more than the Biden administration.
Speaker Change: considering what appears to be a lack of appreciation in Washington. Tim,
Speaker Change: on the benefits of the biopharma industry to the American public at large and to the economy in the country.
Speaker Change: Could you comment on how Bristol's leadership team and board are engaging differently today with Washington to defend the industry and company?
Speaker Change: and then separately regarding the Cobency, Adjunctive Trial Failure, could you talk about...
The more disappointing results in the risperidone subgroup.
Speaker Change: and whether the company believes that Resparadone DDIs with Kobenfi may have impacted the efficacy in that subgroup and how you may potentially evaluate Kobenfi in combination with other therapies in the adjunctive setting in the future. Thank you. Thank you.
Speaker Change: Thanks for the questions, David. I'll ask Samit to start and then I'll come back and answer your more general questions.
Speaker Change: Sure. Thank you, David, for the question. So for our eyes, certainly as David has already, Chris has already mentioned, we saw a notable improvement in terms of band scores. If you think about patients who received the non-prisperidone,
Antisecotic Therapy, certainly we are evaluating and assessing. Thank you very much.
Speaker Change: All have a news in terms of understanding the data and respect on population including the DDI potentials and PGP in 26 and all of those enzymatic pathways. With all of that said there is a lot more work to be done to look at other endpoints in the trial as well. Thank you very much.
Speaker Change: Once all of that is done, then we will be able to define the next step soon which could include engaging with the regulators apart from obviously the treating positions as well as conducting additional studies as we look to the future. [inaudible]
Speaker Change: And then with respect to your more general industry question, look I think we agree with your perspective that America has a real gym in the biopharmaceutical industry, over 70% of the research and development in this space takes place in the United States. And what drives that is a very healthy ecosystem that supports innovation, rewards innovation, and ultimately ensures that companies like ours can do everything we can to deliver innovative medicines, [inaudible]
Speaker Change: to patients and do so quickly, Americans have benefited from having access to more innovation faster than patients anywhere else in the world.
Speaker Change: Having said that, we're going to continue to do what we've always done, which is focus on strengthening the ecosystem for innovation in the US. That means ensuring that we are able to continue to invest in strong areas and interesting areas of science, supported by a strong intellectual property framework. We're going to continue to invest in the ecosystem for innovation in the US.
Speaker Change: We're going to also continue to engage with the government on pricing and the support of...
The payment for innovation on the back end. [inaudible]
Speaker Change: We've talked about the need to fix the more egregious aspects of IRA notably the pill penalty and addressing some of the spillover risk that we saw.
in IRA. [inaudible]
Speaker Change: We also want to ensure that we're making the US ecosystem less complex, that means addressing the role that middle men play.
Speaker Change: And then an area that we absolutely agree with this administration is outside of the U.S. getting countries to allocate more healthcare dollars to support innovative medicines like those.
Speaker Change: that we make it Bristol Myers Squibb. So those are really our main areas of focus. We're going to continue to engage with our farm but partners to engage the administration, we'll also be engaging directly, and that's going to be our continued focus.
Thank you, Chris. Let's take our next question please.
Speaker Change: The next question will come from Carter Gould with Cantor, please go ahead. [inaudible]
Speaker Change: Good morning. Thanks very much for taking the question. The BD messaging is coming through clear and the focus on that endogenous events won't be a stage gate is clear. I guess my question is more on exogenous events and the extent to which uncertainty around tariffs, FDA, drug pricing environments are sort of stage gates to being able to move on drug pricing either a hold up on your side or on the target side. Thank you. Thank you very much.
Speaker Change: I'll take that one Carter. I think you mean that any of those exogenous factors having an impact on our ability to do business development. Thank you very much.
Speaker Change: Look, I think, you know, we clearly have been focused on putting ourselves in a very strong financial position. We do that by frankly executing on the business as you saw us do in this quarter that we've been discussing today. But also as David referenced by continuing to focus on making the company more efficient and more agile, that enables us to pull costs out of the system and puts us in a stronger position. This is a great opportunity for us to be able to do this. This is a great opportunity for us to be able to do this.
Speaker Change: That financial flexibility gives us the ability to be much more engaged on business development. Thank you very much.
and Frank Lee.
Speaker Change: You know, that I think is way more important than any of the exogenous factors that you referenced. And so again, I would just reiterate business development remains our top priority. We have the financial position. [inaudible]
Speaker Change: to move on business development, but we're also going to be very disciplined. We're going to stay focused on those opportunities where we like the science, where we're the rightful owners, and importantly where we can continue to improve the growth profile of the company. [inaudible]
Thank you Chris, let's take our next question.
Speaker Change: Our next question will come from Stephen Scala with TD Cowan. Please go ahead.
Speaker Change: Thank you so much to questions, probably both for some of it. Just to be absolutely clear on your prepared remarks and answers to questions, and I know that you need to speak with regulators, but Bristol seems to see a path to positive regulatory action on the existing arise data.
Speaker Change: Is that correct or is there no such path? So that's the first question. Second question is, to what extent did the Millvexian phase three trial benefit?
Speaker Change: from the competitive phase three stoppage, for instance, did enrollment jump, 10%, 20%, and given that, why hasn't timing of the primary end point changed?
Speaker Change: We're events, for instance, running behind in the patients previously enrolled before the competitor set back. Thank you.
Comment, you want to take those? Yeah, thank you, Steve, as usual, great questions for Arise.
Speaker Change: Look, we would not obviously speculate right now as I said earlier, we need to do all of the work to understand all of the data, including the additional endpoints that we have not yet looked at, and we will plan to then engage with the regulators to define what the next steps would be. [inaudible]
Speaker Change: For Melvixian, we certainly continue to manage and monitor the events that we are observing. As we've said before, our overall event rate remains very low for HLF. We have not re-projected the timelines. We will continue to work together, J&J and ourselves. [inaudible]
Speaker Change: and we will communicate if there is a change in the timeline in terms of the readout. As you know, we've already communicated. We still look forward to the readout for the ACN SSB trial in 2026, and then AF is in 2027.
Great, thanks on it. Let next question please.
Speaker Change: The next question will come from Seamus Fernandez with Guggenheim. Please go ahead. The next question will come from Seamus Fernandez.
Speaker Change: This is Zack Dunn on For Seamus Fernandez. Thank you for the questions. If you're from us on Kemsios and your CMI portfolio, firstly, how defensible is your first in class position with Kemsios? You're the first.
Speaker Change: such as your establishment at Ph.M. Centers and Updated Rhymes in light of our free campton.
Potentially coming to market this year. [inaudible]
Speaker Change: and then to non-obstructivism and myosin inhibition, what read through if any might there be to your development efforts in HEPPS?
Speaker Change: How would you characterize prospects for success in half-path with NYK-224? Thank you.
Speaker Change: Thanks, both great questions, Adam and then Samit. Yeah, let me start. Thanks for the question. So as I mentioned, we continue to deliver strong growth and steady growth with Cam Ziles. We've established a very strong revenue base and expect continued growth.
Speaker Change: from expanding our prescarbubies. We're seeing very high persistencies of long durations of treatment and we're continuing to add new patients each and every week. [inaudible]
Speaker Change: We're focused right now on increasing our depth of prescribing in the Lord's theory, even the label changed that we mentioned earlier should help accelerate that.
Speaker Change: We're also making good progress expanding into a community of cardiology accounts and receiving solid growth and increasing number of trialists.
Hitch and every week.
Speaker Change: You know, as it relates to competition, you know, we've always planned for competition in the space.
Speaker Change: We don't see any meaningful clinical differentiation versus epicampin. We've now had the opportunity to talk to literally hundreds of thought leaders and...
Speaker Change: Almost all have said that. At the camp and the data that they presented appears undifferentiated. So, it's going to be important to see what their data in the label looks like later in the year. But, you know, we'll be prepared for when At the Camping comes to market. We maintain a consistent view that will remain leaders in this space.
Chris Boerner: Yeah, and thank you for the question on the NHCM results, and they backed on HEPF for MBA224. Look, we still have to do a lot more digging into the data, as Chris has mentioned. We do know obstructive hypertrophicardomapathy versus a non-obstructive hypertrophicardomapathy is a suggestion of a differential disease because of the outflow tract obstruction in one versus the other. [inaudible]
Chris Boerner: As it relates to HFF, remember how NHCM study was designed and where we had seen the impact on the biomarkers, anti-proBNP, as well as on the Trapon NT. We had hoped that those changes in the biomarkers will translate into a clinical benefit and outcome in NHCM did not happen.
However, as we think about half past [inaudible]
Chris Boerner: for MBIK-224. Once those results are available, then we'll be able to say more, the impact overall on the FF program, I think, is too early to comment on that.
and Sean McCutcheon
Thank you. No, next question please.
Chris Boerner: The next question will come from Hassad Hayter with Goldman Sachs. Please go ahead.
Hassad Hayter: Thanks for taking the question. Maybe just going back to capital allocation and I know a lot has been answered already, but just...
Speaker Change: You know, if you could just unpack Chris what's driving this renewed emphasis on B.D., if you could you know unpack that a little bit more in the context of the lack of visibility, some of the structural challenges that the industry is facing, and then any comments on size? Thank you very much.
Hassad Hayter: and what exactly you're looking to solve for is you scan the landscape of external assets. Is it near-term revenue growth or earlier stage assets and what are the therapeutic areas of interest? Thanks.
Hassad Hayter: Sure. Well, let me be really clear. Capital allocation focused the focus that we have hasn't changed. [inaudible]
Hassad Hayter: Business Development is a top priority. We said that last quarter and the quarter before that.
Hassad Hayter: We are focused on strengthening in our key therapeutic areas that we know well and improving the growth profile of the company.
Hassad Hayter: Those are the things that I think we've consistently said. With respect to size, we don't evaluate opportunities focusing on size. What I would say is that the way we think about any opportunity from a business development standpoint is we put it through a set of filters.
Hassad Hayter: We're in a strong position to do a lot of things, but the way we think about it is does it strengthen the therapeutic areas that we're in and you know those well. [inaudible]
Hassad Hayter: Are they areas where we have an ability to add to the science and we're the rightful owners of it?
Do the financials make sense?
Hassad Hayter: But I would say that's how we think about our top priorities right now. Thanks Chris.
Speaker Change: Next question please. The next question will come from Matt Phipps with William Blair, please go ahead.
Matt Phipps: Hi, thanks for taking my question. Two quick ones. I know it's early days, but any particular indications or physician settings where you're seeing more adoption or more interest in caveantics so far. And then independence trials coming up. Just, you know, how meaningful is this market up to expansion? And can you give us any sensible would be a clinically meaningful benefit and transfusion independence? Thank you. Thank you.
Matt Phipps: Adam. Yeah, thanks for the question. We're making good progress without David O'Cuban, I think we're...
Matt Phipps: Now around three months post launch, the feedback has been positive. What we're seeing is the majority of the youth thus far has been in the community setting, about 80% has expected. And we're focused on continuing to increase breath of prescribing and doing that both in community and in academic settings.
Laughing on mention is what we have shared previously. Thank you very much.
Matt Phipps: Therefore, the sub-two conversion will take time to ramp. We'll get that J-code July 1st issued, and thus we expect a second half ramp. So overall, we're pleased what we're seeing in the early days of the launch.
Unknown Executive, Christopher Boerner, Chuck Triano
Speaker Change: And I think the second question was regarding MF, overall opportunity. So...
Matt Phipps: I could take that too. So thanks for the question. So as relates to to the minor fibrosis,
Matt Phipps: and Anemia Associated MS4, MS4 Rebels going. The opportunity there is a pretty modest commercial opportunity. The majority of the business for Rebels is going to be driven by the indication we have from command. And that's first line. Our teams are focused on really driving that first line RS negative patient.
Matt Phipps: We're making good progress in the United States, we're also unlocking reimbursement outside of the US as well, so we expect continued growth there.
Matt Phipps: The next readout for Rebelsville, that's going to be important. It's going to be the non-transusion dependent readout. We'll open up another part of the marketplace. But again, we're focused on really driving the indications that we have today in first line. The next readout for Rebelsville, that's going to be the non-transusion dependent readout for Rebelsville,
Thanks, Adam. Right, move to our next question.
Speaker Change: The next question will come from Sean McCutcheon with Raymond James, please go ahead.
Sean McCutcheon: Hey guys, thanks for the question. So for the Excalibur study with MRD negativity read out later in the year, do you suspect that you could be able to obtain an approval on that MRD?
Sean McCutcheon: Negativity Outcome as an Intermediate Endpoint, and with the movement of CAR-T into second line and later, how do you think this shapes the opportunity and the bar for utilization of a bird of mind in the trip, let it be, it does show benefit over DVD, thanks.
Sean McCutcheon: Thanks for the question, Sean, Samit even starting in Adam, maybe weighing on a lot of part of that one. Sure, so remember the trial is designed with MRD and then there's the PFS and then there's overall survival at its endpoints and again very important study for the second-line plus population.
Sean McCutcheon: The overall as we look at the MRD data, we will have to look at the totality of the data that other endpoints are moving in the right direction because the supportive evidence would be needed from a regulatory perspective as the regulators look at this that the other endpoints are not going in the opposite direction. [inaudible]
Sean McCutcheon: So again, when the data reads out, we'll be able to say more in terms of the regulatory possibility. I'll just add one more thing in terms of the placement. I'll just add one more thing in terms of the placement.
Sean McCutcheon: Of Iberto Mide, once the data are read out and if they're positive and the drug gets approved, remember we've talked about it before as well.
Sean McCutcheon: There's a large amount of patients who are treated in the community setting. So small molecules and combinations are going to be required in the community setting and therefore there is that unmet medical need that will be fulfilled with Iverdomite and in the future of Music Domite as well. Thank you for joining us today.
Yeah, thank you so much.
Speaker Change: So as you know, this is a very crowded, competitive market, but as Samit was alluding to, it's a very fragmented market as well with a lot of room for additional entrance. So yes,
Speaker Change: in Treatment in these CAR-T centers of excellence, which represent a relatively small percentage of the market. In fact, the majority of the market over 70% of multi-bioloma is treated in the community at a summit with a looting too. [inaudible]
Speaker Change: Well, we're excited about for the novel Selma's agents in Multimilamilis that number one, they provide a tailored approach of efficacy with a manageable toxicity profile, combined ability as well as an oral convenience.
Speaker Change: Samit talked about it, we've got four ongoing pivotal trials, of course Iburn Mezzi, for Iburnmide, a triple combination combining well with Dara, as well as moving even further up line, head-to-head versus Revolmed, and a post transplant, maintenance, setting, and for
Speaker Change: The Calder Study for Mezzi, there's a lot of excitement there around the potency of Mezignum Eye, which has the opportunity to read out as well, potentially, you know, in early 2026, this is...
and our most potent cell mod combining well in triplet combination with PI. So taking the other work cited about the potential launches of these important assets. [inaudible]
All right, thanks Adam. Let's move to the next question please. Thank you.
Speaker Change: The next question will come from Kripa, Devarakonda, with true securities, please go ahead.
Speaker Change: Hey guys, thank you so much for taking my question. I have one question on your radio franchise and then maybe a big picture question.
and, first line...
Speaker Change: Walter Lunkancer, that's expected later this year. And then maybe a big picture FDA question. You know, the FDA commissioner has recently made a lot of comments on his vision for changes at the FDA at different levels. Was there anything in particular that you think might have a significant impact on, you know, either the timelines or how you do drug development or post marketing surveillance. Thank you.
Speaker Change: Thanks for the questions, Kripa, maybe Samit, you could take over those. Yeah, thank you, Kripa. So, yes, truly looking forward to the read-out of the phase one study in extensive stage, Small Salon Cancer, where...
Unknown Executive, Christopher Boerner, Chuck Triano
Speaker Change: You'll have to compare that to the historical controls to see what the overall efficacy looks like, where chemotherapy does work well, but the durability has generally been challenging in terms of maintaining that response.
Speaker Change: So all of that data is what we are expecting to see as we look towards the back end of this year, as the trial reads out and that will then set up the stage for taking it further in patients with SSDR2 expression in their small cell lung cancer. [inaudible]
Speaker Change: From the FDA perspective, I think that's far what we've seen from our perspective. Thank you very much.
Speaker Change: There are approvals have come on time. In fact, some of the approvals have come before time, if you think about the first time HCC, approval that we recently got as well as for the MSI High Covertile Cancer Approval are meetings for across therapeutic areas, continue to be on time. Some of them are actually in person now going forward. This is the first time HCC has come before the MSI High Covertile Cancer Approval has come before the MSI High Covertile Cancer Approval.
Speaker Change: So overall, we are very constructively and collaboratively working with the regulators to ensure that transformational therapies that we are developing are not delayed and we will certainly continue to work with administration as well as the regulators to convey the point if we start to see any change in those timelines for any of the activities that are going to be critical to bring these medicines to patients on time. Thank you very much.
Thanks, Amit. Next question, please.
Speaker Change: The next question will come from James Shin with Deutsche Bank, please go ahead. [inaudible]
James Shin: Morning guys, thanks for the question. One for Chris. Sorry to believe or macro Chris, but totally, and totally understand the backdrop is still fluid, but is there an initial data point or policy decision that will inform next steps? For example, with having visibility on US corporate tax reform, be a starting point, or would you need the actual form of terror rates?
James Shin: or any color like that to budget accordingly, and then one for Somit. What are your thoughts on the recent PD-1 budget data sets? Specifically, does the data look consistent? Does it look competitive to PD-1? Just get your views there. [inaudible]
Unknown Executive, Christopher Boerner, Chuck Triano
Speaker Change: Maybe I'll start and then summit you can take over. Look, I think that there are multiple aspects of the policy environment that are in flux and we're going to be monitoring each and every one of those. I don't think there's one that rises to
Speaker Change: More prominence than the other, they're all important at some level. What I would say if you just step back though, if the goal here is to ensure that we continue to invest in research and development and that we're investing in the United States, one thing we should not overlook is one of the points you just made, which is the importance of tax policy. This is one of the points you just made, which is the importance of tax policy, which is the importance of tax policy, which is the importance of tax policy.
Speaker Change: The US tax rate and making the US corporate tax rate more competitive is critically important. In fact, when you go back to 2017 and the corporate tax rate came down to 21%, you saw a positive impact on investment in the United States. [inaudible]
Speaker Change: R&D, and so I think that in the focus that a lot of folks have on tariffs and on what may happen in the US and actually US pricing environment, we shouldn't move sight of the importance of tax. [inaudible]
Sam, I think from the PD-1 VJF perspective. . . . .
Speaker Change: The data continues to evolve in the right direction, I would say.
Speaker Change: He's going to be, what is the impact on safety? Right now it seems at least from the press release we saw is it's comparable between the two arms. So we'll have to just look at those those parameters. So let's just look at those parameters.
Speaker Change: As it applies to us, I would just close it out from that perspective that we have a large portfolio in non-small cell lung cancer which is obviously precision driven as well as
Speaker Change: Looking at overall portfolio also building on the I.O. franchise as we think about the I.O.'s a Latlimap combination with Octivo, so we have a lot of work to do in non-small cell lung cancer, but we certainly keep an eye on these data. . . . . . . . .
Speaker Change: Thanks, Samit. We know you all have a busy day, so if I can just turn to Chris for some closing remarks, then we'll wrap up the call. Thank you very much.
Chris Boerner: I think what you see in the quarters, our growth portfolio is delivering. We've shown good progress, we're better aligning our cost structure with our revenue base, and many of our key pipeline readouts remain in front of us. In fact, we are just at the very beginning of the wave of catalyst that we have coming. We're in a strong financial position which affords us. [inaudible]
Chris Boerner: Options in terms of capital allocation priorities in business development. And before we close, I want to recognize our colleagues.
Chris Boerner: for all of their hard work and of course even in these uncertain times we remain committed to our overarching goal which is to...
Chris Boerner: Re-shape and optimize the MS to deliver top-tier growth by the end of the decade and most importantly, generate attractive returns for shareholders. So again, thank you all for tuning in today and as always the teams available for follow-ups and have a great rest of the week.
Speaker Change: The conference is now concluded. Thank you for attending today's presentation. You may now disconnect.
She's alive
[music]
Unknown Executive, Christopher Boerner, Chuck Triano
Unknown Executive, Christopher Boerner, Chuck Triano