Courtney Breen

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 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 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 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 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 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 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 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 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 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 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 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 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 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.