Courtney Breen

Courtney Breen asked about the flu mRNA-1010 RTF, specifically the percentage of patients 65 or older in the efficacy study. She also inquired about the INT program's path to approval, any feedback on the clinical trial design that provided recommendations not followed, whether Merck or Moderna will file the BLA, and if CBER will be the assessing FDA group.

Answer

Stephen Hoge, President, clarified that the Phase III flu efficacy study had over 50% of its 41,000 participants over age 65, with strong, consistent superior efficacy. For INT, he confirmed robust and productive engagement with FDA and global regulators, with CBER at FDA involved. Merck is the sponsor for the Phase III study and will submit the BLA.

Courtney Breen asked about the percentage of patients aged 65 or older in the 41,000-person Phase III flu efficacy study, feedback on the INT clinical trial design, whether Merck or Moderna will file the BLA for INT, and if CBER will assess the file.

Answer

Stephen Hoge, President, clarified that in the 41,000-person Phase III flu efficacy study, over 50% of patients were 65 or older, with over 10% above 75, showing strong superior efficacy across all age groups. He distinguished this from a separate 3,000-person immunogenicity study. For INT, he confirmed robust and productive engagement with global regulators, including CBER at the FDA, for the novel individualized neoantigen treatment. Merck is the sponsor for the Phase III study and will lead the BLA submission.

Courtney Breen (Bernstein) probed further into Moderna's R&D cuts, asking if more reductions are possible without stopping programs or changing the prioritized asset list, given the efficiencies garnered and the new approach.

Answer

President Stephen Hoge confirmed expectations for further reductions in R&D costs over the coming year and two, driven by the sunsetting of existing prioritized investments. He stated that these reductions are anticipated to occur without further program stops and will include continued investment in early-stage programs, which are less cash-intensive.

Courtney Breen probed further on the R&D cuts, asking if more cuts are possible going forward, or if future reductions would require stopping programs or changing the prioritized list of assets in the pipeline, in contrast to just efficiency gains.

Answer

Stephen Hoge, President, confirmed expectations for further reductions in R&D costs in the coming years. He stated that these reductions are anticipated to occur without further program stops, primarily due to the sunsetting of existing prioritized investments in the infectious disease vaccine portfolio and continued investment in less cash-intensive early-stage programs. He emphasized that completing the work started several years ago will naturally drive these cost reductions.

Courtney Breen inquired about the new first-line metastatic melanoma trial for INT, asking if a patient could receive the therapy twice, and requested more context on which departments were affected by the recent headcount reduction.

Answer

President Stephen Hoge explained it's conceivable a patient could receive INT twice, as the therapy is re-individualized based on the tumor's current neoantigens. CEO Stéphane Bancel specified that headcount reductions were focused on manufacturing, R&D (as large trials wind down), and G&A, driven by productivity gains, while hiring continues in strategic growth areas.

Courtney Breen asked about the drivers behind the newly announced cost-cutting measures, questioning what milestones or changes prompted the increase and where the company found the flexibility to do so.

Answer

CFO Jamey Mock explained that the cost reductions are primarily a result of the planned wind-down of several large Phase III trials by 2027. He stressed the focus on controllable costs to achieve the 2028 breakeven target. The savings will come from trial completions, procurement efficiencies, and the implementation of digital tools.

Courtney Breen asked about the ongoing issue of inventory write-downs for seasonal vaccines, questioning what a 'good' level of write-downs would be in the future and what operational changes are being made to minimize them.

Answer

CFO Jamey Mock acknowledged that 2024's $600 million in write-downs and unutilized capacity was 'not what good looks like.' He stated the company is improving by reducing raw material inventory and optimizing its manufacturing footprint, citing a recent contract termination. The long-term goal is for these costs to be less than 10% of sales.

Courtney Breen asked for the rationale behind the INT-009 trial design in non-small cell lung cancer and questioned what primarily gates the expansion of the INT program into other tumor areas.

Answer

President Stephen Hoge explained the trial design reflects the evolving standard of care towards neoadjuvant KEYTRUDA, aiming to show benefit in patients who don't achieve a pathologic complete response. He stated that program expansion is paced by a disciplined approach to starting large studies and is not primarily limited by manufacturing capacity, with more Phase 3 programs planned.

Courtney Breen sought clarification on the $800 million Sunlenca guidance for 2026, questioning if it implies no growth in new patient starts compared to current trends and a significant year-over-year price cut, and whether this guidance represents a floor.

Answer

Johanna Mercier, Chief Commercial and Corporate Affairs Officer, responded. She clarified that Gilead's modeling assumes continued strong momentum and acceleration of growth for Sunlenca in 2026, driven by new patient starts and return for second injections. She emphasized that while access is strong, pull-through at the account level and navigating logistics for an injectable in an oral market takes time. Johanna reiterated expectations for strong, consistent, and durable long-term growth for Sunlenca, with the direct-to-consumer campaign expected to significantly impact patient inquiries and adoption.

Courtney Breen sought clarification on the 2026 guidance for Sunlenca, questioning whether the $800 million figure represents a floor given assumptions about new patient starts and potential price cuts.

Answer

Johanna Mercier, Chief Commercial and Corporate Affairs Officer, clarified that Gilead's guidance assumes continued strong momentum for Sunlenca, including new patient starts and second injections, leading to an acceleration of growth in 2026. She emphasized the team's success in achieving strong access and ongoing efforts to navigate logistics at the account level. She reiterated expectations for strong, consistent, and durable long-term growth for Sunlenca, anticipating a significant impact from the direct-to-consumer campaign.

Courtney Breen of Bernstein asked why Gilead did not raise its 2025 guidance for Yes2Go, given the positive early launch dynamics and better-than-expected access.

Answer

Chief Commercial Officer Johanna Mercier provided two key reasons for maintaining the current guidance. First, she stressed that it is still very early, with the launch being only six weeks old. Second, and more critically, broad payer access needs to be secured. While the team is successfully managing one-off medical exceptions, she stated they need to see the number of covered lives increase more formally over the next one to two quarters to ensure sustained momentum and justify a guidance revision.

Courtney Breen of Bernstein asked why Gilead did not raise its 2025 guidance for Yes2Go given the positive early launch momentum and what uncertainties remain.

Answer

Chief Commercial Officer Johanna Mercier responded that while the launch is strong, it is still very early at only six weeks post-approval. She explained that the critical variable is converting initial interest into broad, covered access. Until the company sees a significant increase in the number of covered lives over the next one to two quarters, it is premature to update revenue expectations.

Courtney Breen asked about the development of once-yearly lenacapavir for PrEP, inquiring about the potential for an expedited trial design, such as a PK/PD-based package, instead of a full efficacy trial.

Answer

Chief Medical Officer Dietmar Berger acknowledged the question was insightful and confirmed that Gilead is currently evaluating different study designs for the once-yearly formulation. He stated that a PK-based approach is a possibility that is being discussed, but did not commit to a specific regulatory pathway at this time.

Courtney Breen asked for CMO Dietmar Berger's thoughts on the competitive landscape in small cell lung cancer (SCLC), specifically how targets like TROP2, DLL3, and B7-H3 might compare and shape the market long-term.

Answer

CMO Dietmar Berger highlighted the impressive Phase II data for Trodelvy (TROP2) in SCLC and its Breakthrough Therapy designation. He positioned TROP2 as a potential foundational therapy in the second-line setting, while noting that other targets like DLL3 are interesting and that data for B7-H3 has been mixed.

Courtney Breen inquired about the characterization of cost savings planned for 2026 relative to 2025 achievements and sought clarification on the drivers behind the projected $1.5-$2 billion step-down in Eliquis sales from 2026 to 2027, given the new pricing baseline.

Answer

David Elkins, EVP and CFO, confirmed significant progress on the $2 billion strategic productivity initiative, achieving over $1 billion in 2025, with the remaining $1 billion spread over 2026 and 2027, enabling reinvestment in growth drivers while reducing costs. Adam Lenkowsky, Executive Vice President and Chief Commercial Officer, reiterated Eliquis's 2026 growth driven by pricing changes. David Elkins clarified the 2026-2027 step-down is consistent with consensus, primarily driven by generic entries in ex-U.S. markets, particularly in Europe late in 2026, as added by Chuck Triano, Senior Vice President and Head of Investor Relations.

Courtney Breen inquired about the characterization of cost savings planned for 2026 relative to those achieved in 2025, and sought clarification on the drivers behind the projected $1.5 billion to $2 billion step down in Eliquis revenue from 2026 to 2027.

Answer

David Elkins (EVP and CFO, Bristol Myers Squibb) confirmed that over $1 billion in cost savings was achieved in 2025, with a solid line of sight for an additional $1 billion spread over 2026 and 2027, enabling reinvestment in growth drivers. Regarding Eliquis, he reiterated the expected 10-15% growth in 2026 and the $1.5 billion to $2 billion step down in 2027, which Chuck Triano (Senior Vice President and Head of Investor Relations, Bristol Myers Squibb) clarified is largely driven by the expiry of EU patents in late 2026, leading to generic entries in major ex-US markets.

Courtney Breen asked about Bristol Myers Squibb's learnings from the first round of PD-1 competition with Merck, specifically how those experiences in development and commercial strategy are being applied to improve their approach in the more complex and competitive PD-1/VEGF opportunity.

Answer

Chris Boerner, Board Chair and CEO, highlighted the key learning that first and second players in the PD-1 race garnered most commercial value, informing their strategy to secure a 'pole position' with the BioNTech deal. Adam Lenkowsky, Chief Commercialization Officer, emphasized Bristol Myers Squibb's experience launching three IO assets, leveraging existing infrastructure, the critical importance of order of entry, strong relationships with community oncologists (70% of U.S. prescribing), agility to pivot for new indications, and the focus on novel indications and combinations to raise the bar on overall survival.

Courtney Breen asked about the learnings from Bristol Myers Squibb's first round in the PD-1 battle, specifically the development and commercial competition with Merck. She inquired what the company would have done differently and how that strategy is being applied to improve its approach in the more complex and competitive PD-1/VEGF environment.

Answer

CEO Chris Boerner highlighted that a key learning was the importance of being a first or second player to capture the majority of commercial value, which informed the BioNTech deal to secure a pole position. Chief Commercialization Officer Adam Lenkowsky emphasized the company's experience in competitive markets, leveraging existing infrastructure, the critical role of community oncologists (70% of U.S. prescribing), and the agility to pivot quickly for new indications. He also stressed the importance of targeting novel indications and combining Pumitomig with other modalities to raise the bar on overall survival.

Courtney Breen from Bernstein asked about the rationale and timing behind the new direct-to-consumer offering for Eliquis with Pfizer, and whether this platform could be expanded to other BMY products.

Answer

CEO Chris Boerner explained the program aims to reduce patient out-of-pocket costs and increase transparency by 'cutting out the middleman,' aligning with administration goals. EVP & Chief Commercialization Officer Adam Lenkowsky provided details, noting the program offers over a 50% discount to list price for uninsured patients. Boerner confirmed they will explore similar opportunities for other products.

Courtney Breen inquired about Bristol's committed capital expenditures for U.S. manufacturing and R&D, and asked how the company approaches M&A decisions in the context of upcoming internal data readouts like milvexian and Cobenfy.

Answer

CEO Christopher Boerner stated that BMS is a significantly U.S.-based company and has been consistently investing in domestic infrastructure with plans to continue. He clarified that business development is approached as a distinct activity, not dependent on the sequence of internal trial results, and that the company is now unconstrained and ready to execute on deals that fit its strategic and financial criteria.

Courtney Breen of Bernstein asked about the company's business development appetite and therapeutic area alignment for 2025, and also inquired about the expected gross-to-net evolution for Cobenfy as its market access expands.

Answer

CEO Christopher Boerner reiterated that BD is a top priority focused on strengthening core therapeutic areas, supported by a strong financial position. CCO Adam Lenkowsky explained that Cobenfy's gross-to-net will be heavily weighted towards public payers like Medicare and Medicaid, which cover the vast majority of patients in schizophrenia and future Alzheimer's indications, with commercial payers representing less than 10% of the business.

Courtney Breen asked about the practical implications of the warnings and precautions on the Cobenfi label, particularly regarding liver monitoring, and its potential impact on physician adoption.

Answer

Chief Commercialization Officer Adam Lenkowsky stated the label is very positive as it avoids the major side effects that lead to discontinuation. He explained that the recommended lab monitoring is not mandated and is common practice for this patient population, so it is not expected to be a barrier to adoption. Samit Hirawat added that long-term safety data reinforces this confident profile.

Courtney Breen asked about the anticipated timelines for Orforglipron approvals and launches in ex-US countries, specifically inquiring if Lilly expects any accelerated pathways similar to those in the US that could enable 2026 launches.

Answer

Patrik Jonsson, President of Lilly International, stated that Orforglipron launches outside the U.S. are mainly anticipated for the first half of 2027, with a few markets potentially launching late 2026, such as the UAE, which might reference FDA approval.

Courtney Breen from Bernstein asked about the potential for accelerated regulatory pathways for Orforglipron in ex-U.S. markets, aiming for a 2026 launch, similar to U.S. approvals.

Answer

Patrik Jonsson, President of Lilly International, clarified that Orforglipron's international launch is primarily expected in the first half of 2027, with a few markets in late 2026 and exceptions like the UAE potentially referencing FDA approval. Mike Czapar, SVP of Investor Relations, directed the question.

Courtney Breen asked about the potential for market expansion with orforglipron, given Lilly's preparations for a large-scale launch and significant manufacturing capacity, and whether this could lead to a slowdown in Zepbound new starts.

Answer

Ken Custer, President, Lilly Cardiometabolic Health, highlighted orforglipron's profile (efficacy/safety comparable to injectable GLP-1s, glucose/weight benefits, simple once-daily pill, scalable manufacturing). He sees a generational opportunity to reach hundreds of millions or billions globally, beyond current incretin users. He views orforglipron as both a starter incretin and a maintenance option (ATTAIN-MAINTAIN study), expecting market expansion rather than Zepbound cannibalization.

Courtney Breen asked about the potential for orforglipron's large-scale launch to support 5 million patients, its market expansion capabilities, and whether it might slow down Zepbound new starts.

Answer

Kenneth Custer, President, Lilly Cardiometabolic Health, emphasized orforglipron's strong profile (efficacy, safety, oral, scalable) as a generational opportunity to reach hundreds of millions globally. He stated that it's expected to grow the market significantly, not cannibalize Zepbound, and could also serve as a maintenance option.

Courtney Breen of Bernstein asked about the observed differences in GI side effects for orforglipron between the ATTAIN-1 (obesity) and ACHIEVE-1 (diabetes) studies and the potential implications for real-world patient adherence.

Answer

Dr. Daniel Skovronsky, Chief Scientific Officer, explained that the side effect profiles were consistent with historical data for a GLP-1 monotherapy in their respective patient populations. He noted that while dual agonists like tirzepatide offer superior results, the orforglipron profile is likely 'as good as it gets' for a once-daily oral GLP-1 monotherapy.

Courtney Breen asked for clarification on the number of current Zepbound patients covered by CVS Caremark, given investor concerns about the formulary change.

Answer

Patrik Jonsson, President of Cardiometabolic Health, stated he could not share a specific number of lives but emphasized that the change applies to a subset of CVS plans, not the entire account. He added that the employer opt-in rate for obesity coverage within that specific subset is believed to be on the lower end, suggesting the impact may be more contained than perceived.

Courtney Breen of Bernstein asked about the potential market positioning for Orforglipron, given its anticipated efficacy is similar to a single injectable GLP-1.

Answer

Executive Daniel Skovronsky noted that efficacy expectations are benchmarked against single GLP-1s like Ozempic, not dual-acting tirzepatide. Executive Patrik Jonsson added that its oral formulation targets patients with needle aversion and offers an opportunity to scale in ex-U.S. markets.

Courtney Breen of Bernstein asked about the ATTAIN MAINTAIN trial for orforglipron, suggesting its placebo-controlled design points to a market expansion strategy focused on treatment duration rather than product displacement.

Answer

Patrik Jonsson, President of Lilly Cardiometabolic Health and Lilly USA, agreed that orforglipron is a significant market expansion opportunity due to its oral formulation. He framed the ATTAIN MAINTAIN trial as a way to understand how to best maintain patients on chronic therapy, viewing it as an alternative to improve long-term outcomes rather than a direct switching strategy from injectables.

Courtney Breen asked about MariTide's maintenance and less frequent dosing opportunity, specifically its market role, whether it's only for post-MariTide weight loss, and the potential for switching opportunities, including the type of data needed for such positioning.

Answer

Murdo Gordon, EVP of Global Commercial Operations, emphasized MariTide's paradigm-changing potential for weight loss, diabetes, ASCVD, and heart failure. He sees it as effective for both initiating treatment to achieve weight goals and for long-term maintenance with convenient monthly, bi-monthly, or quarterly regimens, also noting its potential for patients switching from other therapies.

Courtney Breen from Bernstein asked about the potential market role of MariTide's less frequent dosing for maintenance, exploring whether it's exclusively for post-MariTide weight loss or if it presents a switching opportunity from other therapies, and the type of data needed to support this positioning.

Answer

Murdo Gordon, EVP of Global Commercial Operations, described MariTide as a paradigm-changing product for weight loss, diabetes, ASCVD, and heart failure management. He sees it as effective for initiating patients to reach weight goals and for long-term maintenance with convenient, well-tolerated, and efficacious monthly, every eight-week, or quarterly regimens. Gordon also confirmed the potential for patients on other therapies to switch to MariTide, indicating an 'all of the above' strategy.

Courtney Breen questioned the clinical rationale for Meritide's three-step dose escalation in Phase 3, asking how physicians are expected to select the correct maintenance dose immediately following titration.

Answer

James Bradner, EVP of R&D, explained the design optimizes tolerability and efficacy for the monoclonal antibody. He noted the trial will provide a graded understanding of dose-response, which will guide physicians and patients in selecting optimal long-term maintenance therapy.

Courtney Breen asked about the anticipated market evolution for Repatha, considering its upcoming primary prevention data and the potential for new competition from oral PCSK9 inhibitors.

Answer

Murdo Gordon, EVP of Global Commercial Operations, emphasized Repatha's strong momentum, driven by improved prescriber perception of access and affordability. He noted that Repatha is positioned to compete based on its proven ability to reduce hard cardiovascular events, not just lower LDL, setting a high bar for new entrants.

Courtney Breen asked for more context on the growth trajectory for TEPEZZA, specifically when the impact of the expanded sales team is expected to materialize, given the Q4 guidance.

Answer

EVP of Rare Disease Vikram Karnani explained that the 8% YoY growth is being supplemented by a new strategy to reach low CAS patients. This involves a reorganized and expanded field force, split into two dedicated teams, which was implemented in Q3. He expects this new focus to gain traction over the next several quarters and also highlighted the upcoming launch in Japan in early 2025.

Courtney Breen inquired about the expected R&D spending in 2027, considering the annualization of the 20+ pivotal studies starting in 2026, and asked when and where the impact of Pfizer's AI investment, including the 1,200 GPU deployment, would be seen in R&D operations or research innovation.

Answer

CFO Dave Denton explained that while 2027 guidance isn't provided, the increased R&D burden from business development transactions is being managed by improving productivity within the $11 billion R&D investment. CEO Albert Bourla highlighted AI's role in creating significant productivity gains across R&D, manufacturing, and commercial, enabling cost reduction without affecting activity. Chief Scientific Officer Chris Boshoff noted AI's embedding across R&D functions to increase speed and reduce cost. Chief U.S. Commercial Officer Aamir Malik cited AI's use in field force productivity and increasing Marketing ROI. Chief International Commercial Officer Alexandre de Germay mentioned AI's impact on pre-call planning, targeting, and accelerating regulatory approval for promotional materials globally.

Courtney Breen from Sanford C. Bernstein & Co., LLC inquired about the R&D spending outlook for 2027, considering the 20+ pivotal studies starting in 2026 and the $11 billion guide for 2026. She also asked when and where the impact of Pfizer's AI investment, including the 1,200 GPU deployment, would be seen, and if it would affect R&D operations for pivotal trials or primarily research innovation.

Answer

Dave Denton, CFO, Pfizer, explained that while 2027 guidance isn't provided, the increased R&D burden from business development is being managed by improved productivity, allowing for more investment. Dr. Albert Bourla, Chairman and CEO, Pfizer, highlighted that AI is ready for deployment now, affecting enabling functions, R&D, marketing, and manufacturing. Dr. Chris Boshoff, Chief Scientific Officer, Pfizer, specified that in R&D, AI is embedded across all functions to increase productivity (speed and cost). Aamir Malik, Chief U.S. Commercial Officer and EVP, Pfizer, gave examples of AI improving field force productivity and marketing ROI. Alexandre de Germay, Chief International Commercial Officer and EVP, Pfizer, noted AI's impact on pre-call planning, targeting, and accelerating regulatory approval for promotional materials globally. Dave Denton concluded that AI leverages vendor platforms and automates routine transactions across numerous markets, driving efficiency.

Courtney Breen sought to understand the factors that supported Pfizer in receiving an unprecedented early termination of the HSR waiting period from the U.S. Federal Trade Commission for the Metsera acquisition.

Answer

Albert Bourla, Chairman and CEO, Pfizer, indicated that the FTC made its own decision, likely influenced by the antitrust concerns surrounding Novo Nordisk's competing offer, which he described as an attempt to acquire Metsera's entire pipeline and eliminate an emerging competitor. Dave Denton, CFO, Pfizer, added that this early clearance further demonstrates the strength of Pfizer's deal and its clear path to completion.

Courtney Breen sought to understand the factors that supported Pfizer in receiving an unprecedented early termination of the HSR waiting period from the U.S. Federal Trade Commission for the MedSera acquisition.

Answer

Albert Bourla, Chairman and CEO, stated that the FTC made its own decision, aware of the situation, and decided it was appropriate to clear Pfizer's deal. Dave Denton, CFO, added that this demonstrates the strength of Pfizer's deal and its pathway to clearance, which is beneficial to patients. Albert Bourla further commented that Novo Nordisk's attempt represents the 'epitome of antitrust conflict' given their dominant market position.

Courtney Breen of Sanford C. Bernstein & Co., LLC requested more context on SG&A efficiencies, specifically where resources are being reallocated versus pulled back, and asked for an update on M&A priorities, including interest in obesity and immunology.

Answer

EVP & Chief International Commercial Officer Alexandre de Germay and EVP & Chief U.S. Commercial Officer Aamir Malik detailed efficiency gains from focusing on key markets and brands, consolidating agency partners, and leveraging technology. CEO Albert Bourla confirmed continued interest in obesity and other key areas for M&A, noting a disciplined approach to capital deployment.

Courtney Breen of Bernstein asked for more context on SG&A efficiencies, specifically where investments are being reallocated versus pulled back, and for more insight on M&A priorities, particularly in obesity and immunology.

Answer

EVP & Chief International Commercial Officer Alexandre de Germay and EVP & Chief U.S. Commercial Officer Aamir Malik detailed efficiency strategies, including focusing on key international markets and leveraging technology in the U.S. Chairman & CEO Albert Bourla confirmed M&A interest in obesity and I&I, noting a large number of opportunities but stressing a disciplined approach to capital deployment.

Courtney Breen asked for an update on inventory management in preparation for potential tariffs and whether the company plans to host an R&D Day in 2025.

Answer

CEO Albert Bourla confirmed that Pfizer has taken necessary mitigation steps, including building up inventory within the U.S. Chief Scientific Officer Chris Boshoff stated that a full R&D Day is not planned, but the company will continue to use targeted 'flash events' to provide deep dives on specific pipeline areas, such as an upcoming event on breast cancer.

Courtney Breen sought clarification on the new R&D structure of four end-to-end organizations and asked how Pfizer ensures high standards and proper investment prioritization across these independent units.

Answer

Executive Chris Boshoff confirmed the new structure mirrors the successful end-to-end models in oncology and vaccines. Executive Andrew Baum explained that prioritization is driven by bringing a commercial lens to the process much earlier to ensure financial value. CEO Albert Bourla added that the focus is on better selecting which high-potential products to advance.

Courtney Breen noted a perceived lack of pipeline advancement in the last three months and asked if this was due to cost-cutting, and how Pfizer will ensure high-potential assets are still accelerated.

Answer

EVP and Chief Oncology Officer Chris Boshoff countered this perception by detailing significant upcoming activity, including multiple Phase III readouts and new trial starts. Chief Scientific Officer Mikael Dolsten added that across the entire pipeline, there are up to 40 opportunities for approvals, pivotal readouts, or proof-of-concept data expected over the next 18 months, indicating a full slate of activity.

Courtney Breen asked how AbbVie's U.S. versus ex-U.S. business exposure might change in five years, driven by product mix or pricing policies, and sought quantification of the expansion opportunity from RINVOQ's label changes.

Answer

Rob Michael, Chairman and CEO, stated that while the current U.S.-OUS mix is 75%-25%, historical levels (2/3 U.S., 1/3 OUS) might be a better long-term indicator, driven more by product mix than pricing policies. Jeff Stewart, Executive Vice President, Chief Commercial Officer, noted that the enhanced IBD label for RINVOQ is a clear net incremental positive, though not fully quantified, and will build over time as the IBD treatment paradigm shifts from heavy TNF focus.

Courtney Breen asked about the expected shift in AbbVie's U.S. versus ex-U.S. business ratio in five years, considering product mix and pricing policies, and sought quantification of the expansion opportunity associated with the recent RINVOQ label changes.

Answer

Chairman and CEO Rob Michael stated that while the U.S. vs. international mix is not publicly disclosed long-term, historical levels (two-thirds U.S., one-third international) before Humira's LOE could be a guide, with portfolio mix being the larger driver. EVP and CCO Jeff Stewart described the enhanced RINVOQ IBD label as a clear net incremental positive, allowing earlier use in certain patients and strengthening AbbVie's competitive position, though not fully quantified yet.

Courtney Breen from AllianceBernstein questioned if AbbVie has sufficient U.S. inventory for key products like Rinvoq and Botox through 2027 to mitigate tariff impacts, and asked about the pricing strategy for the short-acting BoNT/E, given its shorter duration of effect.

Answer

CEO Robert Michael declined to speculate on the impact of tariffs absent specific policy details, stating the company would be transparent once details are known. CCO Jeffrey Stewart noted that the pricing for BoNT/E is premature but will be determined closer to launch. He suggested that while a shorter duration might imply a lower price, the value it brings to practices by attracting new patients with high lifetime value would be a key consideration.

Courtney Breen of Bernstein inquired about the cost savings program, specifically how resources would be reallocated from KEYTRUDA's SG&A as it nears its loss of exclusivity to fund new product launches.

Answer

Chairman & CEO Robert Davis explained the strategy is to broaden leadership in oncology beyond KEYTRUDA. He stated that spending will be reallocated and increased to support the wider oncology portfolio, with spend on other oncology assets growing as KEYTRUDA-specific spend is reduced.

Courtney Breen of Bernstein inquired about the cost savings program's impact on KEYTRUDA, specifically how SG&A spending for the drug would be reallocated to newer opportunities as it approaches the end of its lifecycle.

Answer

Chairman & CEO Robert Davis clarified that the goal is to broaden Merck's leadership in oncology beyond just KEYTRUDA. He explained that spending will be reallocated and increased for the broader oncology portfolio, including antibody-drug conjugates and small molecules, as the company moves away from being solely focused on KEYTRUDA.

Courtney Breen asked for clarification on two points: the risk of an inventory write-off for GARDASIL sitting with Zhifei in China, and the breakdown between price and volume for the guided $400 million impact from Medicare Part D redesign.

Answer

CFO Caroline Litchfield clarified that since the GARDASIL inventory is owned by their partner Zhifei, the risk of a write-off for Merck is 'extremely low.' Regarding the Part D redesign, she explained that the $400 million negative impact is predominantly a pricing impact, which will be partially offset by some volume benefit as patients stay on therapy longer.