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U.S. business Bristol Myers Squibb was founded in the early 1800s and aims to combine the reach and resources of a global pharma company with the entrepreneurial spirit and agility of a biotech firm. European sites in Germany, Ireland, Switzerland, Belgium, France and the U.K. host employees. Global flexibility guidelines aim to optimize working patterns for each individual around their role, family responsibilities, health needs and personal preferences. A sense of purpose runs through the company, from influencing EU policies to philanthropy; an employee giving program, administered by the BMS Foundation, doubles staff's financial contributions to eligible charitable organizations. In 2022 the organization donated £2 million to NHS cancer services, charities and patient groups.

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Modern Board 2023-Bristol Myers Squibb

Last year, the New York–based Bristol-Myers Squibb tied ESG initiatives to executive compensation in a first for the pharmaceutical company. That effort came after a 2022 initiative to have 25% of clinical trials in diverse communities. CEO Giovanni Caforio chairs the 11-member board, of whom 10 are independent directors. Other directors include Peter Arduini, president and CEO of GE Healthcare, and Paula Price, who most recently served as Macy’s chief financial officer. Deepak Bhatt, director of Mount Sinai Heart, is the latest board appointment, tapped for his extensive cardiovascular research and clinical trial expertise. In June, the board <a href="https://www.fiercebiotech.com/biotech/bms-strikes-roche-rivalry-41b-acquisition-turning-point">approved the acquisition</a> of cancer drug company Turning Point Therapeutics for $76 a share in a deal totaling $4.1 billion. The firm is still scouting for new M&amp;A deals, Caforio said in its latest earnings call, as the pharma giant tries to offset a sales loss from two drugs that lost patent exclusivity last year. Also in 2022, the company laid off roughly 170 employees due to redundancies from its 2019 acquisition of Celgene. Women and minorities separately make up 36% of the board. Current chief operating officer Christopher Boerner will succeed Caforio when he steps down in November.

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The Fortune 500, in its 69th year in 2023, ranks the biggest U.S. companies by revenue.

F500-2023-095-Bristol Myers Squibb

The New York City–based pharmaceutical giant had a lackluster 2022, dropping 13 spots on the Fortune 500 as its revenue decreased by 0.5% and profits dropped 9.5% from the prior year. 
<ul> 
 	<li>In 2022, Revlimid, a cancer drug, lost exclusivity in the U.S., which allowed generics to eat into its market share. Once a company blockbuster, the drug saw a 22% decrease in revenue from $12.8 billion in 2021 to approximately $10 billion in 2022.</li> 
 	<li>Bristol-Myers Squibb’s other top drugs, Eliquis, an anticoagulant, and Opdivo, used for chemotherapy, brought in 21% and 15% more revenue, respectively, for 2022.</li> 
 	<li>The company faces a steep patent cliff ahead as exclusivity for Eliquis and Opdivo is set to expire in 2028, and BMS is actively investing to find another drug to add to its portfolio, spending $9.5 billion in 2022 on research and development.</li> 
</ul>

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Aggregate sales hit $37.8 trillion last year—an increase of 19%, the highest annual growth rate in the list’s history.

Modern Boards 2022 Bristol Myers Squibb

The board at pharmaceutical company Bristol-Myers Squibb scored high on age dispersion, and for having a high number of senior independent nonexecutive directors. Bristol-Myers Squibb’s board has three current CEOs, including its own, Giovanni Caforio, and Peter Arduini, CEO of GE Healthcare. Also on the board is Derica Rice, former CVS Health EVP and president of CVS Caremark, the pharmacy benefits management (PBM) business. 
 
Though the company is facing a patent cliff, <a href="https://seekingalpha.com/article/4496603-bristol-myers-squibb-on-track">analysts are optimistic</a> that BMS’s strong pipeline and cash flow will help carry the company in the long run. In 2021 BMS brought in <a href="https://news.bms.com/news/corporate-financial/2022/Bristol-Myers-Squibb-Reports-Fourth-Quarter-and-Full-Year-Financial-Results-for-2021/default.aspx">$46.4 billion</a> in revenue, exceeding its annual target and registering 9% year-on-year growth. The company also <a href="https://www.fiercepharma.com/pharma/bristol-myers-ceo-caforio-takes-pay-cut-employee-metric-drags-down-bonus">reported strong</a> performance on supply-chain reliability and COVID-19 response, with a 99% vaccination rate among its employees in the U.S. and Puerto Rico. BMS published its first <a href="https://www.bms.com/about-us/global-diversity-and-inclusion/diversity-and-inclusion-report.html">global diversity and inclusion report</a> in 2021, setting goals to achieve gender parity at the executive level globally and to double the number of Black and Latinx/Hispanic executives in the U.S. by the end of 2022. 
 
BMS <a href="https://news.bms.com/news/details/2022/Bristol-Myers-Squibb-to-Highlight-Long-Term-Growth-Strategy-at-J.P.-Morgans-40th-Annual-Healthcare-Conference/default.aspx#:~:text=Bristol%20Myers%20Squibb%20plans%20to,dividend%20and%20share%20repurchase%20program.">plans to leverage</a> up to $45 billion in free cash flow in the next two years to execute a capital allocation strategy prioritizing business development and returns to shareholders. The company <a href="https://www.marketwatch.com/story/bristol-myers-squibb-sets-5-bln-accelerated-stock-buyback-bmy-271644409304">recently executed</a> a $5 billion accelerated share repurchase agreement during the first quarter, part of a multiyear $15 billion buyback program.

Organizations on this annual list positively impact people and communities across multiple countries.

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The New York City–based pharmaceutical company delivered strong financial results in 2021, with total revenue growing 9% year over year to $46.4 billion. Bristol-Myers Squibb enjoyed strong sales for drugs like Revlimid and Opdivo, used in the treatment of certain cancers; and Eliquis, an anticoagulant. Its product-development pipeline also looks healthy: In 2021, the company obtained more than 20 regulatory approvals for new medicines.

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Total revenue for the world’s biggest companies fell 4.8% to $31.7 trillion this year—the first decline in half a decade.

<span data-sheets-value="{&quot;1&quot;:2,&quot;2&quot;:&quot;The New Jersey–based drugmaker jumped up 40 places on this year’s list—with 62.6% revenue growth—because of the additional sales that came with its $74 billion acquisition of Celgene in 2019. Sales of BMS’s anticoagulant Eliquis and its immuno-oncology drug Yervoy also showed strong growth in 2020. The company won 13 additional drug or formulation approvals in the U.S., European Union, and Japan last year; it also acquired MyoKardia, a biotech focused on cardiovascular diseases, for $13.1 billion in November 2020.&quot;}" data-sheets-userformat="{&quot;2&quot;:12673,&quot;3&quot;:{&quot;1&quot;:0},&quot;10&quot;:2,&quot;11&quot;:4,&quot;15&quot;:&quot;Calibri&quot;,&quot;16&quot;:11}">The New Jersey–based drugmaker jumped up 209 places on this year’s Global 500 list—with 62.6% revenue growth—because of the additional sales that came with its $74 billion acquisition of Celgene in 2019. Sales of BMS’s anticoagulant Eliquis and its immuno-oncology drug Yervoy also showed strong growth in 2020. The company won 13 additional drug or formulation approvals in the U.S., European Union, and Japan last year; it also acquired MyoKardia, a biotech focused on cardiovascular diseases, for $13.1 billion in November 2020.

This year’s Fortune 500 marks the 67th running of the list.

F500-2021-75-Bristol-Myers Squibb

<span data-sheets-value="{&quot;1&quot;:2,&quot;2&quot;:&quot;The New Jersey–based drugmaker jumped up 40 places on this year’s list—with 62.6% revenue growth—because of the additional sales that came with its $74 billion acquisition of Celgene in 2019. Sales of BMS’s anticoagulant Eliquis and its immuno-oncology drug Yervoy also showed strong growth in 2020. The company won 13 additional drug or formulation approvals in the U.S., European Union, and Japan last year; it also acquired MyoKardia, a biotech focused on cardiovascular diseases, for $13.1 billion in November 2020.&quot;}" data-sheets-userformat="{&quot;2&quot;:12673,&quot;3&quot;:{&quot;1&quot;:0},&quot;10&quot;:2,&quot;11&quot;:4,&quot;15&quot;:&quot;Calibri&quot;,&quot;16&quot;:11}">The New Jersey–based drugmaker jumped up 40 places on this year’s list—with 62.6% revenue growth—because of the additional sales that came with its $74 billion acquisition of Celgene in 2019. Sales of BMS’s anticoagulant Eliquis and its immuno-oncology drug Yervoy also showed strong growth in 2020. The company won 13 additional drug or formulation approvals in the U.S., European Union, and Japan last year; it also acquired MyoKardia, a biotech focused on cardiovascular diseases, for $13.1 billion in November 2020.

For an astounding 13th straight year, Apple claims the top spot in Fortune’s annual ranking of corporate reputation, based on a survey of almost 3,800 executives, directors, and analysts.

This year's Fortune Global 500 generated $33.3 trillion in revenues and $2.1 trillion in profits.

G500-2020-487-Bristol-Myers Squibb

The biopharmaceutical company manufactures medicines for diseases including cancer, diabetes, and psychiatric disorders.

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F500-2020-115-Bristol-Myers-Squibb

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Wal-Mart stayed on top as its sales crept closer to half-a-trillion dollars. Apple moved into the top five. And UnitedHealth Group continued its steady climb. 

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Bristol-Myers Co. and Squibb Corp. merged in 1989 to form what’s now one of the world’s largest pharmaceutical companies. Bristol-Myers Squibb develops, licenses, manufactures, and delivers biopharmaceutical products for the treatment and management of diseases including HIV/AIDS, cancer, blood disorders, and cardiovascular and fibrotic conditions.

Q2 2025

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Bristol-Myers Squibb (BMY): Company Profile, Stock Price, News, Rankings

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Bristol-Myers Squibb

bristol-myers squibb

Good day, and welcome to the Bristol Myers Squibb Second Quarter twenty twenty five Earnings Conference Call. All participants will be in a listen only mode. After today's presentation, there will be an opportunity to ask questions. Please note this event is being recorded. I would now like to turn the conference over to Mr. Chuck Triano, Senior Vice President and Head of Investor Relations. Please go ahead, sir.

Thank you and good morning everyone. We appreciate you joining our second quarter twenty twenty five earnings call. Joining me this morning with prepared remarks are Chris Berner, our Board Chair and Chief Executive Officer and David Elkins, our Chief Financial Officer. Also participating in today's call are Adam Lemkowski, our Chief Commercialization Officer and Samit Hirawat, our Chief Medical Officer and Head of Global Drug Development. 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. 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. 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. Reconciliations of certain non GAAP financial measures to the most comparable GAAP measures are available at bms.com.

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 and L are on a non GAAP basis. And with that, I'll hand it over to Chris.

Thanks Chuck. Welcome and thank you for joining our second quarter earnings call. In Q2, we continue to make good progress reshaping the company for long term sustainable growth. I'm pleased with our performance and our financial results speak to that.

Building on the momentum from the first quarter, we saw strong demand across our growth portfolio and continue to optimize our cost structure to match the needs of our business. Let's double click on our quarterly performance on Slide four. Our growth portfolio delivered another strong quarter with sales increasing 17% year over year, primarily driven by demand across all key brands. David will provide more color on our portfolio's performance in his remarks. In addition to strong performance in our growth portfolio, we continue to make regulatory progress across the globe.

In Europe, we secured approval for both Opdivo and neoadjuvant lung cancer and for Cuvantik across multiple solid tumor indications. Additionally, in The U. S, we appreciate recent actions by the FDA that have resulted in streamlined patient monitoring requirements and the removal of REMS programs for all cell therapies. This is expected to enable more patients to benefit from these transformative therapies over time. With respect to capital deployment, we announced strategic partnerships with BioNTech to expand and extend our immuno oncology leadership as well as with PhiloChem to strengthen our radiopharmaceutical business and expand our focus in prostate cancer.

I will discuss these deals in a moment. With the results achieved in the quarter, we are again raising our top line guidance as well as our bottom line guidance before considering acquired IP R and D charges in the quarter. Our recent launches of COBINFY and QVANTIC are progressing well. COBINFY has delivered strong performance since launch and we have consistently received positive feedback from physicians. They are seeing firsthand the medicines differentiated profile with robust efficacy on both positive and negative symptoms and improved cognition.

Regarding The U. S. Launch of Qvantik, early feedback is encouraging with strong uptake. Delivering treatment in just three minutes saves time for patients, caregivers, and providers while also improving clinic efficiency, increasing patient comfort, and reducing treatment complexity. Additionally, fewer port procedures streamlined care allowing physicians to treat more patients.

Now moving to recent business development initiatives on slide five. First, we entered into a global strategic partnership with BioNTech to co develop and commercialize BNT327, a potentially transformative PD L1 VEGF bispecific that could set a new standard of care across multiple tumor types. We're excited to bring together BMS' deep scientific and clinical expertise, development and regulatory capabilities, and commercial infrastructure in the IO space with BioNTech's innovation on BNT-three twenty seven. With a strong partner, we're well positioned to accelerate existing clinical trials, expedite time to market and expand the number of indications. The combined capabilities of BMS and BioNTech give us the opportunity to place BNT-three twenty seven within the first wave of launches in this arena, either first or second to market, a critical advantage in terms of maximizing the commercial opportunity.

BNT-three twenty seven has the potential to become another needle moving IO therapy and accelerate our overall growth trajectory. The partnership is off to a great start. We are well underway in advancing a robust joint clinical development program that expands upon the initial indications by further developing BNT-three twenty seven in numerous additional tumor types in combination. We look forward to sharing more information in the future. Separately, in terms of our early stage pipeline, we entered into a license agreement with Philochem for exclusive worldwide rights to OncoACP3. This is a potential best in class radiopharmaceutical therapeutic and diagnostic agent with the opportunity to become a breakthrough treatment for prostate cancer. We believe this collaboration will further strengthen our position in the rapidly advancing radiopharmaceutical space. Earlier this week, we announced a transaction with Bain Capital to form a new company focused on advancing innovative immunology therapies. As part of this transaction, we out licensed five assets to a newly formed company, including three clinical stage compounds and two Phase one ready compounds.

This deal represents a compelling opportunity to accelerate the development of these promising immunology assets while also allowing BMS to participate in future value creation through royalties, milestone payments and a roughly 20% equity stake. BMS will continue to have a strong presence in immunology. We are focusing our immunology R and D efforts in areas where the company is best positioned to lead. These strategic BD initiatives demonstrate our ability and flexibility to continually identify opportunities to both source external innovation and also externalize pipeline assets where appropriate. This is all in support of our objectives of driving improved growth in the outer years and attractive returns for shareholders.

Moving to our key data catalyst on Slide six. We're entering a data rich period. In the next twelve to twenty four months alone, we expect seven registration assets and seven meaningful lifecycle management opportunities. These represent important needle moving events that can de risk the pipeline and help shape our trajectory through the end of the decade, Recognizing we've had a few studies readout this year where results were not as expected, we are reviewing all of our near term studies to best ensure the timely delivery of these programs with the highest probability of success. While we are encouraged by the overall breadth of our pipeline, I would highlight three new molecular entities with near term data readouts.

We expect readouts for Milvexian in acute coronary syndrome and secondary stroke prevention next year and for atrial fibrillation in 2027. Data for admoparent and idiopathic pulmonary fibrosis is expected next year. And we're also expecting to see MRD negativity data in house later this year and PFS data next year from the Phase three EXCALIBRA study of ibernamide. This could provide additional validation of our CELMoG platform as a next generation potential standard of care in multiple myeloma. In terms of lifecycle management, we now have several ongoing registrational trials for CoBINFY in Alzheimer's disease patients.

These include studies in Alzheimer's psychosis, agitation, and cognition impairment. In addition, we are also enrolling a phase three study in bipolar one disorder. In addition, we have attractive opportunities to invest in numerous oncology pivotal trials. BNT327 is enrolling in first line non small cell lung cancer and small cell lung cancer. And a study in first line triple negative breast cancer is expected to begin later this year.

We're also advancing next generation platforms that could redefine their respective categories. We are initiating two registrational studies for our PRMT5 inhibitor, one in non small cell lung cancer and another in pancreatic cancer based on encouraging early data with additional longer term non small cell lung cancer results to be presented at World Lung. Additionally, we are now recruiting a pivotal study for our EGFR HER3 targeting ADC, IZAPREN, in first line triple negative breast cancer and expect early data in non small cell lung cancer and other solid tumors later this year. Lastly, in immunology, we are also now enrolling patients in a pivotal Phase II study for our CD19 next T cell therapy in severe refractory lupus. Data readouts are expected to continue next year and throughout the end of the decade, providing an increasing line of sight into the strength of our pipeline. We are investing in and prioritizing areas where we see the strongest potential for high value assets.

We are doing what we said we would do, driving focused execution across the business and delivering solid results as we advance our multi year plan to emerge as a top tier sustainable growth company by the end of the decade. Finally, I want to welcome Doctor. Christian Masacezi to BMS who will be joining us starting tomorrow as Executive Vice President, Chief Medical Officer and Head of Development. It's a pivotal time to lead our development organization given the number of key pipeline advancements we are making in the months and years ahead and I look forward to the impact that he will be bringing to our pipeline and the team. I also want to thank Samit for all of his contributions and leadership during his six years at BMS and his commitment to groundbreaking science on behalf of our patients worldwide. With that, I'll turn it over to David.

Thank you, Chris, and good morning, everyone. We continue to deliver strong performance in 2025. Our growth portfolio remains a key focus and we are executing on driving top line growth and prioritizing investments to ensure we are positioning company for long term sustainable growth. Now turning to the second quarter sales performance on Slide eight. Total company revenues were approximately $12,300,000,000 reflecting strong demand across our business.

Global sales of the growth portfolio increased approximately 17%, driven primarily by demand for our IO portfolio, BRYANZI, REBLOZYL and KENZYOS. Let's start a review with the oncology portfolio on Slide nine. Opdivo global sales were approximately $2,600,000,000 up 7%, driven primarily by demand. In The U. S, revenues approximately $1,500,000,000 were largely driven by a strong launch in MSI high colorectal cancer and continued growth in first line non small cell lung cancer.

Outside of The U. S, revenues grew 7%, driven primarily by volume growth and one time favorable adjustments in the quarter. Turning to Kevancik, we are pleased with the performance in the quarter. Sales were approximately $30,000,000 The launch in The U. S.

Is going well with the use across all indicated tumor types. Received a permanent J code on July 1, which will support additional conversion as reimbursement improves. Due to the strong performance year to date, we now expect global Opdivo sales together with KEVANTIC to deliver stronger growth in the mid to high single digit range for the full year. Now turning to our hematology performance on Slide 10. REBLOZYL global sales were $568,000,000 in the quarter and over $1,000,000,000 year to date, reflecting continued strength across our MDS associated anemia indications.

In The U. S, revenue growth was up 30% versus the prior year, primarily due to demand growth in first line RS positive and RS negative MDS associated anemia. Outside of The U. S, Reblozo sales grew 46%, driven by continued demand across newly launched markets. Turning to BRYANZI, revenues were $344,000,000 in the quarter.

Global revenues grew 122% reflecting strong demand across all indications and higher than expected infusions that benefited the second quarter. We expect strong second half with sales skewed more towards the fourth quarter as the third quarter normalizes. In The U. S, sales were $255,000,000 more than doubling again this quarter, which reflects growth in large B cell lymphoma, expansion from new indications approved last year and improved manufacturing success rate. Outside of The U.

S, sales were $88,000,000 nearly tripling due to strong demand and launches in new markets. Moving to our cardiovascular performance on Slide 11, starting with Kamsiyos, global sales were $260,000,000 growing 86% due to robust demand. In The U. S, sales were two fourteen million dollars up 65% driven primarily by increasing new patient starts. Sequentially revenues grew 70% driven by demand as well as a typical second quarter inventory build.

And outside The U. S, sales were $46,000,000 reflecting launch momentum in over 20 markets. Eliquis global sales were $3,700,000,000 growing 6% primarily due to strong demand and U. S. Sales grew 4% and ex U.

S. Sales grew 12%. Moving to immunology on Slide 12. So TYK2 sales grew 29% globally. In The U.

S. Sales increased 5% primarily due to higher demand and an inventory build, which was partially offset by higher rebates associated with increased commercial coverage. We remain focused on driving further demand growth with our improved access position to help offset the impact of higher rebates. Now moving to discuss COBENFI on Slide 13. COBENFI sales were $35,000,000 in the quarter and $62,000,000 year to date.

The launch of Coventry is tracking as we expected. Weekly total prescriptions continue to grow and we expect continued steady growth with sales in the second half of the year higher than the first half. Now let's move to the P and L on Slide 14. Gross margin was approximately 73%, primarily due to product mix. As expected, operating expenses were approximately $260,000,000 lower compared to the same period last year, primarily reflecting the results of our ongoing strategic productivity initiative.

Our effective tax rate in the quarter was 16.1%, including the impact of the upfront charge for the BioNTech partnership. Overall, diluted earnings per share was $1.46 due to the strong performance in the quarter and includes approximately $1,500,000,000 or $0.57 charge related to the BioNTech strategic partnership, which is reflected in acquired in process R and D. Turning to the balance sheet and capital allocation highlights on Slide 15. Our financial position remains strong with roughly 13,900,000,000 in cash, cash equivalents and marketable securities as of June 30. We generate cash flow from operations of about $3,900,000,000 in the second quarter.

Our capital allocation priorities remain unchanged as we continue to take a strategic and balanced approach. Investing in our growth portfolio brands along with business development are our top priorities. We are on track with our plan to further delever our balance sheet and pay down $10,000,000,000 of debt by the 2026 relative to our 03/31/2024 balance. And we remain committed to returning capital to shareholders through our dividend. Now turning to our guidance on Slide 16.

We're increasing our full year reported revenue guidance by $700,000,000 at the midpoint to a range of $46,500,000,000 to $47,500,000,000 reflecting continued strong performance of our growth portfolio, better than expected legacy sales in the second quarter and a favorable impact of approximately $200,000,000 related to foreign exchange rates. Additionally, we now expect the legacy portfolio to decline approximately 15% to 17% for the year, a more moderate rate than previously anticipated due primarily to Revlimid's strong year to date performance. We now project full year Revlimid sales of approximately $3,000,000,000 We maintain our gross margin guidance at approximately 72% as some of our high margin legacy brands are expected to continue to decline through the second half of the year and Eliquis revenues to be more evenly phased throughout the year. We are adjusting our operating expense guidance to increase slightly to approximately $16,500,000,000 reflecting investment behind recent business development deals and additional investment opportunities within our growth portfolio. As previously guided, our operating expenses are anticipated to be higher in the second half of the year compared to the first half, reflecting timing of investments, including the recently signed BD deals.

Our operating margin target of approximately 37% for the full year remains unchanged. For OI and E, we now expect annual income of approximately $250,000,000 due to higher than anticipated royalties and favorable interest income and we're maintaining our full year tax rate guidance of approximately 18%. As a result of the strong performance year to date, when excluding acquired in process R and D charges, the midpoint of our 2025 non GAAP EPS guidance would have increased approximately $0.20 per share. After including these charges of $0.57 per share, primarily related to the BioNTech partnership, our expected EPS for 2025 is now projected to be between $6.35 and $6.65 This increase reflects a strong performance of our growth portfolio as well as better than anticipated sales from our legacy portfolio and accommodates recent business development and other growth oriented investments. All in all, I'm pleased with the performance of the business year to date.

I'd like to thank our colleagues around the world for their continued focus and execution. With that, I'll turn it back to Chuck to start Q and A.

Thanks, David. Operator, can we please start the polling for the Q and A session? Thank you.

Yes, sir. We will now begin the question and answer session. And the first question will come from Geoff Meacham with Citibank. Please go ahead.

Good morning, guys. Thanks for the question. Chris, you mentioned the upcoming period, which is very data heavy. I'm just looking at the Phase III results this year. Are there any that you would call out or maybe you can still achieve the objective of either line extensions or label expansion?

I know you probably have to have an FDA discussion, but I just am curious if there maybe is a faster path to achieving some of the line extensions that you intended to achieve? Thanks. Thanks for the question, Jeff. Let me just say a few things about the studies that I've read out so far and then maybe I'll turn it over to Samit to answer your question directly. First, as we look back at the studies that haven't gone the way we had anticipated, There are two things I think are important to keep in mind.

The first is that when you look at those studies in totality while they were meant to answer important scientific questions or clinical practice questions, they collectively have relatively limited impact on the long term growth of the company. What is more important is whether or not those studies have any implications going forward. And we don't see any read forward from those studies to future opportunities. And so we feel good about where we are in the growth potential as well as the importance of those studies that we'll be reading out over the next twelve to twenty four months in order to shape that growth trajectory. But Samit, maybe you can comment on the studies that read out this year.

Yes. Thank you, Chris, and thank you, Jeff. I think one of the examples of how we think about deeper review of the data would be, let's say, independence trial for Reblozyl, for example. As we've communicated, we look deep into the data and there is clinically meaningful impact that we do see not only on the primary endpoint of transfusion independence, but also as we think about the other endpoints. And so based on that, we are right now planning to interact with the health agencies around the world to ensure that we give the biggest best chance for the drug to be able to show its activity and provide a much needed therapy for unmet medical need in anemia associated myelofibrosis.

And we'll continue to watch out if there are other opportunities for other molecules as we go through the rest of the year.

Yes, sure. Next question please, operator.

Your next question will come from Courtney Breen with Bernstein. Please go ahead.

Hi, guys. Thanks so much for taking the call this morning. We really wanted to focus a little bit on kind of the macro pressures or the industry pressures that you guys are facing and you announced recently the direct to consumer offering in conjunction with Pfizer. Can you give us a bit more context on kind of why this felt like it was the right time to announce this deal? Was this a direct kind of mandate or agreement

And is this potentially a platform that you may look to utilize with any of your other products over time? And what kind of products might be the right ones to fit into a platform like this?

Thanks for the question, Courtney. Maybe I'll start and then I'll turn it over to Adam. Look, we're pleased that we were able to implement this program with Pfizer. I think this administration has actually done a nice job highlighting the need to cut out the middleman from The U. S.

Healthcare system. Remember, roughly about half of every dollar spent on a branded medicine goes to someone who took absolutely no R and D risk in the creation of that product. And the Eliquis direct to patient offering is a way for us to offer meaningful decreases in out of pocket costs for patients, increase transparency, and take a step as the President has suggested in cutting out traditional middlemen. But maybe I'll have Adam speak to the program more specifically.

Yes. Thanks, Chris. And thanks, Courtney for the question. So as part of our commitment to increasing patient access to our medicines, following some of the conversations we've had with the administration, we announced with our Pfizer counterparts a few weeks ago that beginning September 8, uninsured, underinsured cash paying U. S.

Patients could purchase Eliquis directly through Eliquis three sixty support. So patients will be able to pay a discounted rate of over 50% less than the list price. And as Chris was alluding to, we've heard from patients, policymakers, prescribers have all called for a simpler, more affordable, more transparent access and now patients will have full transparency into their costs and it cuts out the middleman there. So we're launching this new direct to patient option as part of our commitment to increasing patient access and affordability.

The only other thing Courtney just to your question about whether there may be other opportunities, we're obviously going to continue to look within our own portfolio see if there are opportunities where that makes sense. And I think we'll also continue to be looking across the industry for other potential opportunities. So, more to come on that.

Thanks, Chris. Let's move to our next question please.

The next question will come from Chris Schott with JPMorgan. Please go ahead.

Great. Thanks so much. Just a two parter on COBENFI. Maybe just first on the launch dynamics. I would love just to hear what you see as the primary hurdles to adoption for physicians at this point given reimbursement etcetera in place?

And the second part was as we look forward to the Alzheimer's psychosis results coming later this year, maybe just help frame out expectations in terms of the type magnitude of benefit you feel you need to show to see adoption here? And would the study alone be enough to support a filing? Thanks so much.

Thanks for the question, Chris. Maybe I'll ask Adam to start on the first part and maybe hit on what the commercial threshold is for ADP and then Samit you can give an update on where we are.

Thanks Chris. COBENTIFI is performing in line with expectations and we're now tracking over 2,000 TRxs on a weekly basis. We expect to see steady TRx growth as we continue to execute our plan and we're still in the early stages of launch. And as we previously communicated, we knew it was going to take time to change what's been decades of entrenched prescribing behavior. And indeed, I think that's been the case.

Physician feedback continues to be very positive regarding COBENFI's differentiated profile. And what's encouraging is that the vast majority of physicians have indicated an intent to prescribe COBENFI. So we're making steady progress with adding number of new trialists as we're growing trialists each week, but we've been we definitely have an opportunity to continue to accelerate breadth and depth of prescribing. So let me talk a little bit about what we're doing and also some of what we're hearing. First, we're increasing the size of our community field force to increase the reach and frequency as we know it takes multiple calls to change physician behavior.

For your question, the most common question that we receive from physicians is how to switch. And we're focused on clarifying switching approaches from D2s to COBENFI through peer to peer initiatives, introducing real world data and we also have a Phase four switch study that reads out at the end of the year. I think all of which will help build confidence. And then finally, we're expanding into the hospital setting. So this is a planned sequence launch first into the community then into the hospital and that opportunity to drive new patient starts.

Patients are typically maintained on treatment from the hospital and then moved into the community. So in the hospitals around twenty percent to twenty five percent of NRxs initiated there. So based on all the leading indicators we're seeing, we're confident that COBENPY is going to be a big drug in schizophrenia and longer term will be fueled by additional indicators such as our Alzheimer's program. So I'll turn it over to Samit to talk about the Alzheimer's program.

Yes. Thanks, Adam. And thank you, Chris for the question as well. CoBNP from Alzheimer's disease perspective, we remain confident in the product and certainly are conducting all our clinical trials with that mindset, not only in the psychosis program, but also for agitation as well as cognition. For ADAPT-two, we're certainly looking forward to the database lock and we remain blinded to that data at this time.

As Chris mentioned earlier during his prepared remarks, we are also reviewing our pre studies to make sure that internally we give the highest probability of success to all of our programs. And specifically as it relates to ADAPT2, in preparation of that database lock, we are conducting the clinical trial site reviews that could impact the timelines a bit. But with that said, we are still targeting the top line data by the end of the year for ADAPT-two. As far as the filing is concerned, as I think as we mentioned already, we are conducting three studies in Alzheimer's disease psychosis, ADAPT-two, ADAPT-four, ADAPT-one. ADAPT-four and ADAPT-one will read out in 2026.

And so two of the three studies need to be positive for us to be engaging the authorities for a filing and registration purposes. We are glad where we are in terms of our enrollments and looking forward to the data readouts.

Great. Thanks, Amit. Next question please.

The next question will come from Evan Seigerman with BMO. Please go ahead.

Hi, guys. Thank you so much for taking my question. I wanted to touch on some of the rationale for partnering with BioNTech and specifically what you saw in their PD L1 VEGF bispecific. There's a lot of assets out there. What attracted you to the partnership with them?

Maybe walk me through some of the differentiation and how you can work with them to accelerate this to potentially be early kind of in the class of assets? Thank you.

Sure. Maybe I'll just say one word and then I'll turn it over to both Adam and Samit first. As I mentioned in the prepared remarks, we're excited about the opportunity that we have with BioNTech. We think this is going to be a really value added partnership for us going forward. One of the things that was particularly attractive was this is an asset that is in a position to be either first or second as this technology evolves.

I mean, we know from our experience in immuno oncology with Opdivo, that that positioning in the marketplace is really important. And so that was one of the factors among many that attracted us to the BioNTech partnership. But maybe, Adam, you and Samit can pick it up from there.

Yes. Thanks for the question, Evan. So our partnership with BioNTech, I think has the potential to enhance our growth profile in the back end of the decade into the 2030s while strengthening and diversifying our oncology portfolio. As you know, we've been a leader in IO now for well over a decade and we do believe that BNT-three twenty seven has the potential to become a new standard of care for many patients and could transform the current landscape as a backbone of cancer treatment. So Chris talked about the importance and certainly learning from Opdivo.

Coming to the market being as a leapfrog to go into a first or second position across tumors is critical. So our focus and some of it will touch on this is around speed to market. We also have the infrastructure in place. We can leverage our capabilities that we've built over years commercializing our three IO agents. And so by leveraging our leading commercial and operational capabilities with BioNTech's scientific expertise, we can help accelerate and broaden the development of the program and explore new indications to maximize the potential.

Yes. And just to build on what Adam just said, look, with two validated targets on a bispecific PD L1 and VEGF, the specificity of delivering the drug to the tumor because of expression of PD L1, that brings a differentiation compared to the PD-one VEGF inhibitors. Of course, we'll need to continue to watch out the evolution of the data across the tumor types that these drugs are being explored in, but certainly very excited to provide our help as well as support and the collaboration because of our footprint in 50 plus countries to conduct clinical trials. Initiation of the clinical trial certainly as Chris mentioned earlier is in small cell lung cancer, non small cell lung cancer and triple negative breast cancer. But there's a large CDP that is being built right now and we'll be able to share that later in the

Thanks for the background. Next question please.

Your next question will come from Louisa Hector with Berenberg. Please go ahead.

Hello. Thank you for taking my questions and maybe a quick thank you to Samit for all the insightful dialogue over the years and good luck. So I wonder if you could quantify the stocking and any gross to net impact. Quite a few mentions, but I don't know if you have the numbers of year on year as well as the Q2 sequential. And then perhaps on the immunology collaboration with Bain, the spin off, just a little bit more color on the rationale for those particular assets going out.

Will you have opt in rights? And are there any other therapy areas where this externalization approach might be useful? Thank you.

Thanks for the question, Luisa. I'll ask David to take the stocking in the first part of the immunology question then maybe Samit you can chime in as well.

Yes. On the raising our guidance by $700,000,000 most of that's driven by demand. And as we take a look at it about a little less than $200,000,000 was related to FX and the majority of that is in our legacy portfolio and in our IO portfolio, which is where more of that business is relative to our growth portfolio is outside The U. S. And the remaining $500,000,000 is pretty much evenly split between the growth portfolio, the pervasive strength that we saw across many of the brands that I talked about in the prepared remarks.

And then as I talked about also, we raised the Revlimid guidance by $500,000,000 but that will be offset good portion be offset by more erosion we're seeing at the frac sand price sale in Pomalyst. But overall, it's a strong raise. We're really pleased with the performance of the growth portfolio and seeing that going into the remainder of the year. So your last question, there was very little stocking that we saw within the quarter. So this is good underlying demand growth.

And just to add to what you asked and what David just said, from an immunology perspective, we've always talked about three elements of targeting the immunology immunological diseases inflammation, resetting the immune system and then creating a homeostasis. And within the inflammation part, we do have SOTIQ2, which is already approved in psoriasis. We recently submitted around the world applications for psoriatic arthritis and we are pursuing additional indications in SLE and Sjogren's syndrome. We have LPA1 in IPF and DPF as we heard before, IPF will read out next year. But what we are truly really excited about is the resetting of the immune system through the use of cell therapies and that's where the emerging data is quite exciting as we think about SLE and more data that will be emerging in systemic sclerosis, myositis, MS as well as myasthenia gravis.

And with the initiation of the pivotal trial, now we have to enroll that as quickly as possible and in a couple of years start to see how we can impact that disease in a positive way.

And just to sort of dovetail back on the rationale for this particular agreement with Bain and how we would think about this going forward. The creation of the new company centers around five assets, three of those assets are clinical stage two or Phase one ready. We have been discussing as you know for the better part of the last eighteen months being diligent to some of its point around portfolio prioritization focusing on those areas where we have a right to win. And as you do that, there are naturally projects that may not make the pay line for us, but still have compelling science or commercial opportunity and this agreement is a nice way for us to continue to progress those assets while retaining the ability to benefit from any upside. And of course, we'll continue to look at innovative ways to do precisely that as we go forward, whether or not we'll be able to leverage a mechanism like this remains to be seen, but we really like this particular structure for these assets and we're happy to kick this off with Bain.

Great. Thank you. Operator, next question please.

Your next question will come from David Asalam with Piper Sandler. Please go ahead.

Thanks. I wanted to ask about KAMZIOS and particularly competitive dynamics with the second myosin inhibitor potentially entering the market by the end of the year early next year. I guess my question here is how are you thinking about your ability to drive a steady cadence of new starts with the additional competition particularly to the extent that aficamtan's REMS potentially is less onerous in terms of echo monitoring. Just how are you thinking about that and your ability to grow the asset not really this year, but longer term, as competitive dynamics intensify? Thank you.

Thanks for the question, David. We'll ask Adam to handle that one. Yes, David. So we've continued to deliver strong growth with Camdios. We're very pleased with performance as we've continued to increase new patient starts and we've established a strong revenue base and we expect that to continue from the expansion of our prescriber base coupled with high persistency.

The feedback on our REMS label change has been very positive that eases the burden of echo requirements for both patients and physicians. And although it's still early days post the label change, we've seen physicians treat more patients at the COEs and we're also making very good progress expanding in the community. As far as Avacamten, we don't see any meaningful clinical differentiation there. Camden also set a very high bar for efficacy and safety. We have compelling real world data across now thousands of patients and we're continuing to grow that every week.

And it's going to be important to see what their label looks like. But we remain focused on driving growth by broadening our prescriber base from the COEs into the community and we will be prepared for Avakamtiv when it comes to market and we will maintain a consistent view that we will remain leaders in this space.

Great. Thanks, Adam. Let's move to the next question.

The next question will come from Dave Risinger with Leerink Partners. Please go ahead.

Thanks very much and congrats on the strong financial performance. So Chris you had highlighted MILVEXI in first when you discussed major pipeline candidates to watch in coming years. And since the Street consensus only models 2032 sales of $2,300,000,000 that reflects a lot of skepticism. So, if you and maybe Sanit could just help us better understand what you think investors under appreciate about MILVEXION's likelihood of success in secondary stroke, ACS and AF? Thanks so much.

Yes. Thanks for the question, Dave. Why don't we have Samit, you start and then Adam, maybe you can speak to commercial opportunity.

Yes. Thank you for the question, David. At MILVEXIAN, we've spoken before about the way we have thought about the development plan. There were two, well conducted studies to define the doses and the doses we differentiated as a single agent versus combination with a background of dual antiplatelet therapy. For atrial fibrillation, we chose the dose of one hundred milligrams BID and you saw the results from the competitor program where the doses did not hit, the overall event rate was much higher.

We have the DMC that continues to observe our data sets. We've enrolled the 20,000 patients in the AF trial. We look forward to the outcomes, but certainly the overall event rate remains low in that program at this time. For secondary stroke prevention and ACS, again, those trials are enrolling really well and we have chosen the dose of twenty five milligrams BID to be able to give a safe region of dosing these patients because of the background of dual anti platelet therapy. Again, DMC continues to look at the data and the studies continue and next year we will be reading out.

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