Terence Flynn

Terence Flynn asked about Arvinas' strategy for potential partnerships for its early-stage programs, balancing the retention of rights versus out-licensing.

Answer

President and CEO Randy Teel explained that with five clinical programs, partnering has been an important part of their past strategy (e.g., Pfizer deal for Vep in 2021, Novartis deal for luxdegalutamide in 2024) and will continue to be considered for future programs to best advance each asset.

Terence Flynn asked about Arvinas' strategy regarding potential partnerships for its early-stage programs, balancing the decision to partner versus retaining full rights for each.

Answer

Randy Teel (President and CEO) stated that with five clinical programs, partnering has been and will continue to be an important part of their strategy. He noted that they keep pharma companies apprised of their pipeline progress to identify potential partners, but reserved more specific program-by-program comments for the future.

Chris, on for Terence Flynn, asked what Arvinas needs to see from the ARV-393 monotherapy data, beyond safety, to feel confident in advancing the asset into a combination trial with Glofitamab.

Answer

CMO Noah Berkowitz responded that 'probably not a lot' is needed beyond confirming the drug's clean safety profile. The main goal is to ensure there are no unexpected toxicities that would interfere with the known profile of Glofitamab, such as hematopoietic toxicity or CRS. Given ARV-393's expected clean profile, the bar for moving to a combination study is not particularly high.

Terence Flynn asked about the implications of the flu RTF for the 2028 cash flow break-even guidance, the timing of the Type A meeting with the FDA, and the refined timing for the INT program's adjuvant melanoma data readout.

Answer

Stephen Hoge, President, addressed the flu RTF, noting international filings are progressing, but US timing depends on the Type A meeting. Jamey Mock, CFO, stated it's too early to comment on 2028 cash flow break-even due to the fluid situation, highlighting other growth drivers and cost momentum. Stephen Hoge added that INT adjuvant melanoma data is event-driven and expected this year, with RCC and bladder also fully enrolled and event-driven.

Terence Flynn asked about the implications of the flu RTF for the 2028 cash flow break-even guidance, the timing for visibility on next steps from the Type A meeting, and the refined timing for the INT program's adjuvant melanoma data readout.

Answer

Stephen Hoge, President, addressed the flu RTF, noting international filings are progressing for a 2027 launch, and the flu/COVID combination is under review in Europe for this year. For the U.S. flu program, a Type A meeting with the FDA is needed within 30 days to understand the path forward. Jamey Mock, CFO, stated it's too early to comment on 2028 cash flow break-even guidance due to the fluid situation with the flu product, but highlighted strong momentum in cost reduction and multiple revenue growth opportunities. Stephen Hoge also mentioned the INT adjuvant melanoma data is an event-driven trial expected this year, with other INT studies (RCC, bladder, pancreatic, gastric) also having readouts.

Terence Flynn asked for confirmation that no cases of GBS have been seen with Moderna's RSV vaccine and sought clarity on the efficacy requirements for the COVID-flu combination vaccine filing, specifically if data is needed for both components.

Answer

President Stephen Hoge confirmed that GBS has not been identified as a risk for their RSV or COVID vaccines. He clarified that efficacy for the COVID component of the combo vaccine has been established, but efficacy for the flu component is still needed. This data is expected from the ongoing standalone flu vaccine (mRNA-1010) trial at the end of the current season.

Terence Flynn requested an update on the progress of the INT manufacturing facility in Massachusetts, asking if it's on track for completion and if any FDA bridging work will be required for approval.

Answer

CEO Stéphane Bancel confirmed the manufacturing plant is progressing on schedule and is no longer on the critical path for approval. President Stephen Hoge added that clinical work will transition to the new plant once operational, and data from that work will serve to bridge the programs for regulatory purposes.

Terence Flynn asked about the blinded serious infection data from the RAINIER study for povetacicept (pove) and the differentiation strategy for the WuXi Biologics tri-specific T-cell engager in B cell-mediated autoimmune conditions relative to pove.

Answer

Reshma Kewalramani, CEO and President, stated that the independent Data Safety Monitoring Board (DSMB) for the RAINIER study continuously reviews blinded and unblinded data and has not requested any changes, giving the study a clean bill of health. Regarding the WuXi deal, she did not disclose specific indications but noted the company's interest in tri-specific engagers for a variety of B cell-mediated diseases beyond IgAN, membranous, and myasthenia gravis, aligning with their commitment to serial innovation.

Terence Flynn asked for comments on the blinded serious infection data from the RAINIER study and how Vertex plans to differentiate its WuXi Biologics tri-specific T-cell engager for B-cell-mediated autoimmune conditions relative to povetacicept within its portfolio.

Answer

Reshma Kewalramani (CEO and President, Vertex Pharmaceuticals) stated that the independent data safety monitoring committee for RAINIER has reviewed ongoing blinded and unblinded data and has not requested any study changes, giving it 'clean bills of health.' Regarding the WuXi deal, she kept specific indications under wraps but noted the excitement for povetacicept as a pipeline-in-a-product for multiple B-cell-mediated diseases, and the interest in tri-specific engagers for a variety of other B-cell-mediated conditions.

Terence Flynn from Morgan Stanley asked for confirmation on whether there was a Gernavix inventory build in Q2 and if the VX-993 data necessitates adjustments to the preclinical models for developing NAV1.7 assets.

Answer

President and CEO Dr. Reshma Kewalramani stated there was no significant inventory to note, only normal hospital buying variability. She explained the VX-993 study was vital for validating and refining their preclinical models, confirming they are at the high end of the dose-response curve for NAV1.8 monotherapy.

Terence Flynn asked for an update on the search for a permanent CEO and about Organon's go-to-market strategy for the denosumab biosimilar, particularly in the osteoporosis setting, considering competitor strategies.

Answer

Carrie Cox, Organon's Board Chair, stated that a robust process for the CEO search is underway but there is no public update to share. Matt Walsh, Organon's Chief Financial Officer, indicated that the denosumab biosimilar is expected to generate approximately $100 million in peak revenues over a five-year timeframe, competing in highly competitive markets.

Terence Flynn of Morgan Stanley asked about the potential impact of a 15% EU tariff on 2026 margins, following the company's commentary on 2025. He also inquired about the outlook for free cash flow conversion and the magnitude of one-time items in 2026.

Answer

Matthew Walsh, CFO of Organon, stated it was too soon to speculate on 2026 tariff impacts but noted the EU represents about two-thirds of U.S. import value. He projected that free cash flow should grow with the business in 2026, with a significant increase in discretionary cash flow expected as one-time costs continue to decline.

Terence Flynn asked for an estimate of Organon's 2025 free cash flow and for commentary on the commercial dynamics and potential erosion curves for its upcoming denosumab biosimilar.

Answer

CFO Matt Walsh projected 2025 free cash flow before onetime items to be around $900 million, a decrease from 2024 due to lower adjusted EBIT. CEO Kevin Ali added that the denosumab biosimilar launch is expected late in Q4 2025, resulting in a de minimis revenue impact for the year, but expressed long-term confidence in market penetration based on the company's experience with RENFLEXIS.

Terence Flynn asked if the trend of synthetic royalties exceeding traditional royalties in announced value would continue, and for Royalty Pharma's perspective on the delayed Novartis Lp(a) trial and its implications for the likelihood of success and Amgen's subsequent readout.

Answer

Chris Hite, EVP, Vice Chairman, affirmed strong excitement for the synthetic royalty market, noting its growth and increasing recognition as a funding solution, and expects the growth trend to continue. Marshall Urist, EVP, Head of Research and Investments, stated that the timing shift for the Novartis Lp(a) trial was not a surprise given the nature of first-in-class outcomes trials and does not change their enthusiasm for the class.

Terence Flynn asked if the trend of synthetic royalties exceeding traditional royalties in announced value will continue, considering the opportunistic nature of deals. He also inquired about the delay in Novartis' pelacarsen Lp(a) trial, its likelihood of success, and potential implications for Amgen's olpasiran readout in 2027.

Answer

Chris Hite, EVP and Vice Chairman, expressed strong excitement for the synthetic royalty market, noting its growth and increasing awareness as a superior funding solution compared to debt or equity. He confirmed the expectation for continued growth in this segment. Marshall Urist, EVP and Head of Research and Investments, stated that the timing shift for the Lp(a) trial was not a surprise due to the uncertainty of event rates in a first-in-class outcomes trial, and it does not change their enthusiasm for the class.

Terence Flynn asked about the AMVUTTRA deal, specifically what differences exist in the current transaction compared to Blackstone's original 2020 deal with Alnylam. He also sought Royalty Pharma's views on the implications for the probability of success of Amgen's olpasiran phase III study, given Amgen's recent report of a slower-than-expected event rate.

Answer

Pablo Legorreta, CEO and Chairman, clarified that the 2020 Blackstone deal was larger and primarily related to Inclisiran, with the 1% AMVUTTRA royalty being a smaller add-on. He highlighted Royalty Pharma's unique perpetual business model, allowing them to hold long-term assets to maturity, unlike closed-end funds, and their differentiated view on AMVUTTRA's sales trajectory and duration. Marshall Urist, EVP Head of Research and Investments, noted that the slower event rate for olpasiran was not surprising given Novartis's similar observation, and while it introduces timing uncertainty, it doesn't change their view on the probability of success for the LP(a) class.

Terence Flynn asked about the differences between Royalty Pharma's recent Amvuttra deal and Blackstone's original 2020 deal with Alnylam, given Royalty Pharma's comprehensive deal review process. He also sought insights on the implications for the probability of success for Amgen's opacirant LP(a) phase 3 study, following reports of a slower-than-expected event rate.

Answer

Pablo Legorreta, CEO and Chairman, clarified that the 2020 deal was larger and primarily for Inclisiran, with Amvuttra being a small add-on. He highlighted Royalty Pharma's unique perpetual structure, allowing them to hold long-term royalties, and suggested their differentiated diligence led to a unique view on Amvuttra's sales trajectory. Marshall Urist, EVP and Head of Research and Investments, acknowledged Amgen's slower event rate for opacirant but stated it doesn't change their view on the probability of success, given the first-in-class nature of the outcome study.

Terence Flynn of Morgan Stanley asked for an update on the adstiladrin royalty performance, the outlook for the non-muscle invasive bladder cancer market, the expected operating expense run rate for 2026, and the company's plans for future share repurchases.

Answer

Head of Research & Investments Marshall Urist expressed excitement for adstiladrin, noting Faring's strong launch and market-building efforts, and sees a growing market, not a zero-sum game with competitors. CFO Terrance Coyne indicated that the H2 2025 operating expense trend of 5-6% of portfolio receipts is strong and heading toward the long-term goal of 4-5%. He added that share repurchases will remain dynamic, balancing the attractive deal pipeline against the share price.

Terence Flynn of Morgan Stanley inquired about how the initial launch of the new Vertex triple combination therapy for cystic fibrosis compares to internal scenarios and asked for thoughts on the less restrictive REMS for Camzyos ahead of the aficamten launch.

Answer

EVP, CFO Terrance Coyne responded that while it's early, the Vertex CF franchise is expected to be a major long-term contributor regardless of the launch scenario. EVP Marshall Urist added that the potential for an evolving REMS landscape was always a contemplated scenario and that their core thesis remains that the hypertrophic cardiomyopathy (HCM) market is large enough for two products.

Terence Flynn requested high-level commentary on the puts and takes for the 2025 outlook and asked for insights into the deal environment for 2025, including any potential implications from the U.S. election.

Answer

Terrance Coyne, EVP and CFO, noted it was premature to discuss 2025 in detail but expressed confidence in the current portfolio, deferring formal guidance to the Q4 call. Christopher Hite, EVP and Vice Chairman, described the deal environment as very strong, driven by immense capital needs across the biopharma sector, and stated that the company's ability to invest is not dependent on the political administration. Pablo Legorreta, Founder and CEO, added that exciting pipeline readouts are expected next year.

Terence Flynn asked about the clinically meaningful delta versus Eliquis that would support broader payer coverage for Milvexian in the AFib study. He also sought confirmation on the mid-single-digit growth year-over-year for the growth portfolio, including Opdivo, in the guidance.

Answer

Cristian Massacesi, Executive Vice President, Chief Medical Officer, and Head of Development, explained that Milvexian's AFib study aims for non-inferiority on efficacy versus Eliquis, followed by superiority for bleeding, which is expected to be clinically meaningful. Adam Lenkowsky, Executive Vice President and Chief Commercial Officer, emphasized Milvexian's multi-billion dollar potential in AFib by replacing first-generation DOACs due to a differentiated bleeding profile and economic benefits. David Elkins, EVP and CFO, confirmed the mid-single-digit growth for the growth portfolio, acknowledging the risk of Orencia generics.

Terence Flynn asked about the Milvexian AFib study, seeking Christian Massacesi's view on a clinically meaningful delta versus Eliquis that would support broader payer coverage. He also asked David Elkins to confirm the mid-single-digit growth year-over-year for the growth portfolio, including Opdivo, in the guidance.

Answer

Cristian Massacesi (Executive Vice President, Chief Medical Officer, and Head of Global Drug Development, Bristol Myers Squibb) explained that Milvexian's primary endpoint is non-inferiority versus Eliquis on efficacy, followed by testing for superiority in bleedings, aiming for a clinically meaningful differentiation. Adam Lenkowsky (Executive Vice President and Chief Commercial Officer, Bristol Myers Squibb) emphasized Milvexian's multi-billion dollar potential in AFib, driven by a differentiated bleeding profile and strong value proposition for payers. David Elkins (EVP and CFO, Bristol Myers Squibb) confirmed the mid-single-digit growth for the growth portfolio, acknowledging the impact of Orencia generics.

Terence Flynn asked about recent headlines regarding CMMI pilots for Medicare, seeking details on any progress or how they might play out. He also inquired about the company's confidence level in the FDA moving forward with a potential filing for iberdomide based on MRD negativity, and whether the FDA would require more definitive data before acting.

Answer

CEO Chris Boerner stated it's too early to comment on CMMI potential demos, as the company is actively monitoring and engaging. CMO Christian Massacesi confirmed that iberdomide showed positive outcomes in MRD negativity rate, an endpoint discussed and agreed upon with the FDA. He stated the company would share data and discuss with multiple regulatory agencies to determine if this readout could grant conditional approval, promising to keep stakeholders posted on next steps.

Terence Flynn asked about recent headlines concerning CMMI pilots for Medicare, inquiring about any progress or details on how these might play out. He also questioned Bristol Myers Squibb's confidence level regarding upcoming discussions with the FDA for a potential iberdomide filing based on MRD negativity, and whether the FDA would require more definitive data before acting.

Answer

Chris Boerner, Board Chair and CEO, stated it was too early to comment on CMMI potential demos, noting active monitoring and engagement. Cristian Massacesi, Chief Medical Officer and Head of Global Drug Development, confirmed iberdomide's positive outcome in MRD negativity rate, which was an endpoint discussed and agreed upon with the FDA. He stated that Bristol Myers Squibb would share the data and discuss with multiple regulatory agencies for potential conditional approval, promising to keep stakeholders posted on next steps.

Terence Flynn requested more detail on the Cobenfy launch, specifically regarding the prescriber base and a one-time gross-to-net adjustment in Q1. He also asked for directional commentary on the operating margin outlook for 2026.

Answer

CCO Adam Lenkowsky described the Cobenfy launch as strong, tracking ahead of benchmarks with broad access, and explained the Q1 gross-to-net benefit was a true-up from a Q4 projection. CFO David Elkins declined to give 2026 guidance but highlighted that ongoing productivity initiatives, automation, and portfolio prioritization provide flexibility to manage the business while investing for growth.

Terence Flynn of Morgan Stanley sought to clarify the year-end 2027 operating expense run rate following the new productivity initiative and asked if the FDA had signed off on using MRD as a co-primary endpoint for iberdomide.

Answer

CFO David Elkins confirmed the operating expense target, stating the $2 billion program would result in OpEx of ~$15 billion by 2027. CMO Samit Hirawat explained that the use of MRD as a co-primary endpoint for iberdomide was discussed with the FDA and that any approval would depend on the overall risk-benefit profile, noting that PFS also remains a co-primary endpoint.

Terence Flynn from Morgan Stanley asked about the Medicare volume ramp embedded in Eli Lilly's 2026 guidance, its impact on revenue, and whether it has influenced commercial employer opt-ins for obesity medicine coverage.

Answer

Lucas Montarce, Chief Financial Officer, stated that Medicare access is expected no later than July 1st, with a gradual build-up, but a positive outlook due to the $50 copay and an estimated 10-20% bolus of existing LillyDirect patients moving to Medicare. He expects Medicare to be a significant opportunity in 2027. Ilya Yuffa, President of Lilly USA and Global Customer Capabilities, added that commercial coverage is stable, with a new team focusing on the employer space and alternative access channels, anticipating increased coverage in late 2026 and mostly 2027. Mike Czapar, SVP of Investor Relations, directed the question.

Terence Flynn asked about the 2026 guidance, specifically the embedded Medicare volume ramp for obesity medicines in the second half of the year and its potential impact on revenue range, as well as any observed effects on employer opt-ins for commercial coverage.

Answer

Lucas Montarce, Chief Financial Officer, stated that Medicare access is expected by July 1st, with a $50 patient copay, which is a compelling value proposition. He anticipates a bolus of 10-20% of current direct business Medicare patients will transition quickly, with further growth in 2027. Ilya Yuffa, President of Lilly USA and Global Customer Capabilities, added that commercial opt-ins are stable, with some employers adding and some removing coverage. Lilly is focusing on the employer space with a dedicated team and third-party collaborations, expecting increased coverage decisions for 2027.

Terence Flynn asked about the path to market for orforglipron, specifically why it wasn't on the initial list for the Commissioner's National Priority Review voucher program, whether Lilly is seeking the voucher, and the expected timelines for launch and 2026 consensus expectations.

Answer

Dave Ricks, Chair and CEO, stated that Lilly is pursuing an 'all of the above strategy' to expedite orforglipron's launch, noting the drug checks multiple boxes for the voucher program. He confirmed the regulatory package would be submitted this quarter, aiming for the quickest possible approval.

Terence Flynn inquired about the market pathway for orforglipron, specifically asking if Eli Lilly is seeking a National Priority Review voucher and how this impacts launch timelines and 2026 consensus expectations.

Answer

Dave Ricks, Chair and CEO, stated that Eli Lilly is pursuing an 'all of the above strategy' to expedite orforglipron's market entry, noting the drug meets several criteria for the voucher program. He emphasized that submissions are imminent, and the company is prepared for a rapid launch.

Terence Flynn from Morgan Stanley asked for expectations for the upcoming ATTAIN-2 Phase III data for orforglipron and for any early insights into a potential CMMI Medicare/Medicaid obesity pilot program.

Answer

Kenneth Custer, President of Lilly Cardiometabolic Health, addressed the first question, stating that after positive results from ATTAIN-1 and ACHIEVE-1, the company expects 'similarly encouraging results' from ATTAIN-2. He noted this third study keeps them on track for a regulatory submission for obesity by the end of the year. The CMMI question was not addressed.

Terence Flynn posed a two-part question on orforglipron, asking conceptually if it would be priced lower than injectables despite similar efficacy, and whether having a portfolio of weight loss drugs would provide additional leverage in PBM discussions.

Answer

Patrik Jonsson, President of Cardiometabolic Health, deferred specific pricing comments but affirmed that having a portfolio targeting different patient segments (e.g., by BMI) would create a position of strength. CEO David Ricks added that Lilly's strategy is to move toward more transparent pricing by reducing the gap between list and net prices, a trend they intend to continue.

Terence Flynn from Morgan Stanley inquired about 2025 expectations for Zepbound payer dynamics, the impact of the OSA label, and the status of compounding litigation.

Answer

Executive Patrik Jonsson stated that commercial access is strong, with the OSA label creating a Medicare opportunity for H2 2025. CEO David Ricks added that Lilly opposes compounding, has full supply, and is involved in litigation to stop the practice.

Terence Flynn from Morgan Stanley requested an early outlook on supply capacity for 2025, with a particular focus on the availability of auto-injectors.

Answer

CEO David Ricks indicated that while detailed 2025 guidance will be provided in February, capital investments made from 2021-2023 are now coming online, and they expect "good growth" in supply next year. CFO Lucas Montarce suggested the current 25% sequential quarterly prescription growth is a reasonable proxy for demand trends entering 2025.

Terence Flynn asked Rob Michael for an update on AbbVie's business development (BD) strategy, including the size and risk profile of potential deals, and Roopal Thakkar for expectations on upcoming Rinvoq and Lutikizumab Phase 3 HS data.

Answer

Rob Michael, Chairman and Chief Executive Officer, stated AbbVie invested over $8 billion in external innovation in the last two years, adding depth to the pipeline across immunology, neuroscience, and oncology. He emphasized a focus on early-stage opportunities for growth in the next decade but confirmed willingness to invest in late-stage differentiated assets in core areas. Roopal Thakkar, Executive Vice President, Research and Development, and Chief Scientific Officer, expressed excitement for Rinvoq in HS, noting its overperformance in other indications, and for Lutikizumab (IL-1 beta) in both naive and experienced populations, aiming for high efficacy and a strong safety profile, positioning it as a lead asset in the naive setting.

Terence Flynn asked for an update on AbbVie's business development (BD) strategy, including the size and risk profile of potential deals, and expectations for the upcoming Rinvoq and lutikizumab Phase III HS data.

Answer

Rob Michael, Chairman and CEO, detailed over $8 billion invested in 30+ early-stage BD deals over two years, emphasizing a focus on future growth drivers while also being open to late-stage differentiated assets in core areas. Roopal Thakkar, EVP, R&D, and Chief Scientific Officer, outlined expectations for Rinvoq in HS (overperforming JAK inhibitor, used in treatment-failure population) and lutikizumab (high efficacy, studied in naive/experienced populations, positioned as a lead asset).

Terrence Flynn asked about the potential implications of Cigna's new PBM model for AbbVie's business and inquired about the outcomes of IRA price negotiations for Vraylar and Linzess.

Answer

Chairman and CEO Rob Michael and EVP and CCO Jeff Stewart explained AbbVie's adaptability to PBM model changes, emphasizing the strength of differentiated medicines. Rob Michael also noted that while IRA prices are not public, the outcomes for Vraylar and Linzess will not impact the company's long-term guidance.

Terrence Flynn asked about the potential implications of Cigna's new PBM model for AbbVie's business and sought comments on the IRA price negotiations for VRAYLAR and LINZESS.

Answer

Rob Michael, Chairman and CEO, stated that AbbVie's performance is driven by differentiated medicines and execution, allowing adaptation to PBM model changes. Jeff Stewart, Executive Vice President, Chief Commercial Officer, added that AbbVie is adaptable to various global market structures. Rob Michael also confirmed that IRA prices for VRAYLAR and LINZESS, while not public, will not impact long-term guidance.

Terence Flynn from Morgan Stanley inquired about AbbVie's confidence in its 2027 long-term guidance for SKYRIZI and RINVOQ given their current strong performance, and also asked about the potential impact of announced EU tariffs.

Answer

CEO Robert Michael stated that AbbVie is tracking very well against its long-term guidance and will provide updates at an appropriate time. Regarding tariffs, he noted the company is insulated for 2025 due to inventory management and does not expect outsized exposure relative to peers, highlighting significant U.S. manufacturing investments.

Terence Flynn from Morgan Stanley inquired about potential mitigation strategies for tariffs, including inventory management and IP domiciling, and sought more detail on the Amylin obesity program's next steps, such as dose escalation and expected efficacy.

Answer

CEO Robert Michael and CFO Scott Reents discussed tariff mitigation, highlighting AbbVie's significant U.S. manufacturing footprint and plans for over $10 billion in future U.S. capital investment. Near-term strategies include inventory management and cost efficiencies. Reents noted AbbVie's tax rate and IP profile are in line with peers, suggesting no outsized impact. CSO Roopal Thakkar explained the Amylin program can test doses several-fold higher than 2mg for up to 12 weeks, with data expected next year to inform a formal Phase IIb study.

Terence Flynn asked for clarification on the volume impact assumptions within the Medicare Part D redesign calculation and inquired about the conviction level for the Phase II UC data for the oral NLRX1 agonist (113) and its potential to advance to Phase III.

Answer

EVP & CFO Scott Reents clarified that while a volume offset is included in the 4% net impact from the Part D redesign, it's modest and not quantified, primarily affecting one-third of the patient segment. CEO Robert Michael added that the other two-thirds (LIS and employer plans) are less affected. EVP & CSO Roopal Thakkar stated the upcoming Phase II study for the NLRX1 agonist will be robust, and if positive, it would become a Phase III asset and a potential combination agent with Rinvoq.

Terence Flynn from Morgan Stanley asked for an update on 2025 contracting for SKYRIZI and RINVOQ, focusing on formulary positioning and the pricing outlook.

Answer

CCO Jeffrey Stewart reported that contracting is nearly complete and they do not expect any material changes to the broad formulary access for SKYRIZI and RINVOQ in 2025. He reiterated expectations for a modest negative pricing environment, with low single-digit changes in rebates.

Terence Flynn from Morgan Stanley sought an update on the design of the MariTide Phase III cardiovascular outcomes trial (CVOT) for type II diabetes, specifically regarding the control arm strategy.

Answer

James Bradner, EVP of Research and Development at Amgen, expressed enthusiasm for MariTide's potential to paradigm-shift type II diabetes management with monthly, bi-monthly, or quarterly dosing. He noted that robust findings from the ongoing Phase II type II diabetes study, including insights from low BMI patients and A1C across dose ranges, position Amgen well for Phase III. Bradner indicated that the specific design of these studies, including control arms and patient recruitment, would be detailed in future engagements.

Terence Flynn asked for an update on the design of the MariTide Phase 3 Type 2 diabetes CVOT trial, specifically regarding the control arm, given recent competitor data.

Answer

James Bradner, EVP of Research and Development, expressed enthusiasm for MariTide's potential to shift the paradigm in Type 2 diabetes management with monthly dosing and efficacy across BMI ranges. He stated that specific design details for the Phase 3 CVOT, including the control arm, would be shared in a future engagement.

Terrence Flynn from Morgan Stanley asked for high-level insights into the puts and takes for Amgen's business heading into 2026, particularly regarding operating margin. He also sought clarification on the Rocket Astro trial, specifically if gastrointestinal ulcerations were observed, given prior study findings.

Answer

Peter Griffith, CFO, emphasized key growth drivers and disciplined capital allocation, noting a "step change" increase in R&D in 2025 not expected to repeat, and highlighted completed Phase 3 studies. James Bradner, EVP of Research and Development, confirmed GI side effects in the Astro study were mostly mild and consistent with other studies, without excessive rates.

Terence Flynn inquired about the high-level puts and takes for Amgen's 2026 guidance, particularly regarding operating margin, and sought clarification on any gastrointestinal ulcerations observed in the ROCKET-ASTRO trial.

Answer

Peter Griffith, CFO, highlighted key growth drivers for the top line and discussed the operating margin strategy, emphasizing continued investment in R&D for late-stage pipeline programs and maintaining industry-leading margins without anticipating another 'step change' increase in R&D expenses. James Bradner, EVP of Research and Development, confirmed that the ROCKET-ASTRO study's safety profile was consistent with other studies, noting that GI side effects were mostly mild and not at an excessive rate.

Terence Flynn asked how recent competitor data from Eli Lilly's SURPASS-CVOT might influence Amgen's design for a future Meritide cardiovascular outcomes trial in Type 2 diabetes, particularly regarding the control arm.

Answer

James Bradner, EVP of R&D, acknowledged awareness of the data and confirmed four Meritide Phase 3 studies are enrolling well. He stated that Amgen would share more about its pivotal study plans for diabetes and related CV outcomes in due time.

Terence Flynn of Morgan Stanley inquired about the key takeaways to expect from the detailed Phase II data for MariTide at the upcoming ADA conference and asked for comments on the potential control arm for its future cardiovascular outcomes trial (CVOT).

Answer

James Bradner, EVP of R&D, stated that the ADA presentation will reinforce MariTide's strong efficacy, sustained weight loss without a plateau at 52 weeks, and good tolerability with an optimized dose escalation. He noted it will also feature new mechanistic data. Bradner declined to provide specifics on the CVOT design but confirmed a broad Phase III program for obesity-related conditions is being initiated.

Terence Flynn asked about the Phase II study of MariTide, specifically if an interim look at quarterly dosing could inform the Phase III program and if the full Phase II data would be presented at the ADA medical meeting.

Answer

James Bradner, EVP of R&D, confirmed that the Phase II Part 1 data for MariTide will be presented at the ADA meeting in June. He also noted that the data readout for the 52-week Part 2 of the study is expected late in the year, but did not comment on a potential interim analysis.

Terence Flynn asked two questions about MariTide: whether the upcoming data would be disclosed via press release or at a medical conference, and if the Phase III trial would require changes to the titration schedule used in Phase II.

Answer

CEO Robert Bradway stated that once the data is in hand, Amgen will share it in a manner that is in the best interest of shareholders. EVP of R&D James Bradner added that Phase III planning is on track and the dosing strategy will be well-informed by the ongoing Phase II study, but declined to provide specific details on the design.

Terence Flynn from Morgan Stanley requested high-level details on the baseline characteristics (e.g., BMI, gender mix) of the VESPER-3 study participants and qualitative commentary on the duration of GI side effects with longer dosing intervals.

Answer

Dr. Chris Boshoff, Chief Scientific Officer, Pfizer, stated that the VESPER-3 study was conducted in the U.S. only, and detailed demographics would be presented at ADA. Regarding tolerability, he reiterated that the overall profile was similar to what is expected for the GLP-1 class, with no alarming cluster of discontinuations or significant AEs when switching to monthly dosing, and only one instance of severe nausea or vomiting across the program.

Terence Flynn requested high-level details on the baseline characteristics of the VESPER-3 study, such as BMI or gender mix, and asked for qualitative commentary on the duration of GI side effects with longer dosing intervals.

Answer

Chief Scientific Officer Chris Boshoff stated that the study was conducted in the U.S. only, and detailed demographics would be presented at ADA. He reiterated that the overall tolerability was encouraging and similar to the GLP-1 class, with no alarmingly high cluster of discontinuations or significant adverse events when switching to monthly dosing, and only one instance of severe nausea or vomiting across the program.

Terence Flynn asked about the delay of the ELREXFIO MagnetisMM-5 trial data into 2026, inquiring about potential differences from J&J's similar trial, and sought clarification on PAXLOVID dynamics for the quarter, specifically an apparent increase in price per script.

Answer

Chris Boshoff, Chief Scientific Officer and President of Research and Development, Pfizer, explained that MagnetisMM-5 is an event-driven study, and a delay in events can be a positive indicator. Dave Denton, CFO, Pfizer, clarified that there was no material change in PAXLOVID's price per script, attributing any perceived increase to different channel mixes. Albert Bourla, Chairman and CEO, Pfizer, also contributed.

Terence Flynn asked about the delay in the MagnetisMM-5 trial for Elrexfio, comparing it to a similar J&J trial, and sought clarification on Paxlovid's Q3 dynamics, specifically regarding an apparent increase in price per script.

Answer

Chris Boshoff, Chief Scientific Officer and President of Research and Development, explained that MagnetisMM-5 is an event-driven study, and timing shifts due to fewer events can be positive, with results expected early next year. Dave Denton, CFO, clarified that there was no material change in Paxlovid's price, attributing any perceived increase to different channel mixes rather than significant pricing adjustments.

Terence Flynn of Morgan Stanley asked if a PFS update from the atiraciclib Phase 2 study would be presented later this year and whether Pfizer is considering exploring Lorlatinib in the adjuvant setting.

Answer

Chief Scientific Officer Chris Boshoff stated that the focus for atemaciclib is now on the first-line Phase 3 trial, which is recruiting well, and a date for the Phase 2 data update has not been disclosed. He also confirmed there are no current plans for an adjuvant study for Lorlatinib.

Terence Flynn of Morgan Stanley asked if a progression-free survival (PFS) update from the atiraciclib Phase 2 study would be provided later this year and inquired about any plans to study Lorlatinib in the adjuvant setting.

Answer

Chief Scientific Officer Chris Boshoff stated that the focus for atiraciclib is now on the first-line setting, with the Phase 3 trial recruiting well, but did not commit to a date for the second-line data release. He also confirmed there are no current plans for an adjuvant study for Lorlatinib.

Terence Flynn asked for confirmation of a potential 'Grand Bargain' on tariffs and how recent Phase III data for Vepdegestrant would impact the drug's strategic plan.

Answer

CEO Albert Bourla stated he was not aware of any 'Grand Bargain' and that discussions are focused on the 232 investigation and the President's executive order on drug costs. Chief Scientific Officer Chris Boshoff reported that Vepdegestrant met its primary endpoint in a key patient sub-population and that full data will be presented at ASCO while engaging with regulators.

Terence Flynn asked about the commercial uptake of ELREXFIO in academic versus community settings and requested details on what data would be shared from the danuglipron dose optimization study.

Answer

Executives Aamir Malik and Alexandre de Germay confirmed strong momentum for ELREXFIO, with increasing adoption in community settings both in the U.S. and internationally. CEO Albert Bourla called it a future 'mega blockbuster.' For danuglipron, Executive Chris Boshoff clarified that Q1 data will be primarily PK data for dose selection, and weight loss data from the small study may not be reliable.

Terence Flynn asked about the likely revaccination frequency for RSV and its market impact, and for more details on the Phase III trial design for the first-line CDK4 inhibitor, atirmociclib.

Answer

An executive stated it was not productive to predict ACIP's revaccination schedule but expressed confidence in ABRYSVO's profile and commercial momentum. EVP and Chief Oncology Officer Chris Boshoff clarified that the atirmociclib first-line study will be against the physician's choice of a CDK4/6 inhibitor, not a direct head-to-head comparison against IBRANCE.

Terence Flynn asked what Regeneron would focus on in Bayer's upcoming Phase III SSP data for their oral Factor XI inhibitor, asundexian, as it pertains to Regeneron's own Factor XI antibody program development.

Answer

Dr. George Yancopoulos, Board Co-Chair, Co-Founder, President, and Chief Scientific Officer, Regeneron Pharmaceuticals, noted the difficulty in comparing small molecules with antibodies, highlighting that small molecules often suffer from lack of specificity and off-target effects. He expressed belief that Regeneron's antibody would offer a differentiated profile with better anticoagulation and improved safety (less bleeding). Dr. Leonard Schleifer, Board Co-Chair, Co-Founder, President, and Chief Executive Officer, Regeneron Pharmaceuticals, added that the antibody could offer convenience with occasional shots, reducing patient burden.

Terence Flynn asked what Regeneron would focus on in Bayer's upcoming phase 3 asundexian (oral Factor XI inhibitor) data, and how it pertains to the development of Regeneron's Factor XI antibody program.

Answer

Dr. George Yancopoulos, Board Co-Chair, Co-Founder, President, and Chief Scientific Officer, Regeneron Pharmaceuticals, noted the difficulty in comparing small molecules (which often lack specificity and have off-target effects) with antibodies (which offer specificity, efficacy, and potentially better safety with less bleeding). He believes Regeneron's antibody has a substantially differentiated and advantageous profile, allowing for occasional dosing.

Terrence Flynn from Morgan Stanley asked about new insights gained from the differential outcomes in the two prior Phase III trials for itepekimab in COPD and potential changes or optimizations for a contemplated third Phase III trial to improve success likelihood.

Answer

Regeneron President and CSO, George Yancopoulos, declined to comment on specific competitive issues or insights due to an upcoming meeting with the FDA, which will inform their future strategy for itepekimab in COPD.

Terrence Flynn inquired about Regeneron's IL-33 antibody, itepekimab, in COPD, seeking insights from the differential outcomes in prior Phase III trials and potential optimization strategies for a planned third trial.

Answer

President and CSO George Yancopoulos declined to comment on specific insights or optimization strategies due to competitive issues and pending discussions with the FDA regarding the strategy for a potential third Phase III trial.

Terence Flynn of Morgan Stanley asked for speculation on why the event rate is slowing in the fianlimab first-line melanoma study and inquired about the confidence level and efficacy bar for a positive result.

Answer

President & Chief Scientific Officer Dr. George Yancopoulos stated that while one can speculate, the study is powered to show an effect at least comparable to competitors. President & CEO Dr. Leonard Schleifer added that this is precisely why studies are blinded and that they must wait for the unblinded results.

Terence Flynn of Morgan Stanley asked for speculation on why the event rate is slowing in the fianlimab first-line melanoma study, the company's confidence in a positive result, and the efficacy bar for success.

Answer

President & CSO Dr. George Yancopoulos declined to speculate on the slowing event rate but confirmed the trial is powered to show an effect at least comparable to competitors, with potential for superiority. President & CEO Dr. Leonard Schleifer added that this is precisely why studies are blinded and one must wait for the data.

Terence Flynn of Morgan Stanley followed up on the EYLEA HD prefilled syringe, asking for confirmation on whether the component under FDA review is the same one used in the syringe already approved and marketed in Europe.

Answer

President and CEO Dr. Leonard Schleifer confirmed it is the 'exact same device, same design and the same components' that were approved and have been used safely in Europe for months. He added this provides confidence that the issues are resolvable, though the FDA conducts its own independent review.

Terence Flynn of Morgan Stanley asked about the upcoming Factor XI antibody readouts, seeking clarity on the decision criteria for advancing one or both candidates into Phase III trials.

Answer

President and CSO Dr. George Yancopoulos explained the two distinct approaches: an A2 domain antibody with an expected milder safety profile and a catalytic domain antibody designed as a best-in-class blocker with higher efficacy. He stated the company hopes to show both are effective and that the decision to advance one or both will depend on their respective efficacy and safety profiles, potentially for different thrombosis indications. CEO Dr. Leonard Schleifer added that Regeneron's antibodies are not created equal to competitors' due to superior in-house technology.

Terence Flynn asked about the positioning of Johnson & Johnson's Tecvayli franchise relative to Carvykti in multiple myeloma, following recent earlier-stage data. He also inquired about the company's plans to implement the FDA's final guidance on MRD negativity and CR endpoints, and its potential impact on development timelines.

Answer

Jennifer Taubert (EVP and Worldwide Chairman of Innovative Medicine, Johnson & Johnson) discussed the significant opportunity in multiple myeloma, positioning Tecvayli plus Darzalex for CD38 naive/experienced patients and Tecvayli monotherapy for refractory patients. She highlighted Carvykti as the leading CAR-T therapy offering a 'shot at cure.' John Reed (EVP of Innovative Medicine R&D, Johnson & Johnson) added that Tecvayli regimens are dexamethasone-free and noted the FDA's unsolicited priority review voucher for MajesTEC-3 data. He confirmed excitement for MRD negativity as a U.S. option, pioneered by J&J, but noted PFS/OS data are still required for other territories. He mentioned the tri-specific antibody Romantomig as a potential candidate for MRD discussions with the FDA.

Terence Flynn from Morgan Stanley inquired about the positioning of Johnson & Johnson's multiple myeloma franchise, specifically Tecvayli relative to Carvykti, following recent earlier-stage data. He also asked about the potential impact of new FDA guidance on MRD negativity and CRs endpoints on development timelines.

Answer

EVP and Worldwide Chairman of Innovative Medicine Jennifer Taubert highlighted the extraordinary efficacy of Tecvayli plus Darzalex (83% reduced risk of progression/death) and Tecvayli monotherapy (71% reduction in disease progression risk) in relapsed/refractory multiple myeloma. She explained that J&J now offers tailored treatment options for every patient in the second- and third-line settings, with Carvykti as the leading CAR-T therapy for a potential cure. EVP of Innovative Medicine R&D John Reed added that Tecvayli regimens are dexamethasone-free, improving quality of life, and noted the FDA's unsolicited offer of a priority review voucher for MajesTEC-3 data. Regarding MRD, Reed confirmed J&J's pioneering role and excitement for its use as an option in the U.S. to accelerate development, particularly for the new tri-specific antibody, Romantomig.

Terence Flynn inquired about upcoming Phase 2 data for Johnson & Johnson's anti-Tau antibody, asking for details on what the company hopes to see, and whether the trial could support an accelerated approval or if a Phase 3 study would be necessary.

Answer

EVP, Innovative Medicine Research and Development John Reed stated that Phase 2 data for the anti-Tau antibody are expected in-house this year and will be shared at a medical congress in the first half of next year. The study includes cognitive endpoints (traditional for regulatory approvals) and neuroimaging data (tau spread via PET imaging). The quality of these data will inform the go/no-go decision, with confidence in the antibody's differentiated epitope and preclinical ability to prevent tau spread.

Terence Flynn asked for an update on Johnson & Johnson's anti-Tau antibody, currently in Phase 2, inquiring about the expected data, what the company hopes to see, and whether the trial could support an accelerated approval or if a Phase 3 study would be necessary.

Answer

EVP, Innovative Medicine Research and Development, John Reed stated that Phase 2 data for the anti-Tau antibody are expected in-house this year, with presentation at a medical congress in the first half of next year. The study includes cognitive endpoints for regulatory approval and neuroimaging data for tau spread. The decision for further development, including potential Phase 3, will be based on the quality of these data, with confidence in the antibody's differentiated mechanism based on preclinical results.

Terence Flynn of Morgan Stanley asked for details on the key assets driving the $50 billion oncology sales target by 2030 and requested an update on the regulatory status of the Ribrevant subcutaneous formulation.

Answer

EVP Jennifer Taubert expressed high confidence in the $50B target, citing strength in multiple myeloma and prostate cancer, and particularly highlighted TAR-200, for which she stated internal forecasts are at least three times higher than 2028 consensus. She confirmed J&J has responded to the FDA's manufacturing-related questions for subcutaneous Ribrevant and anticipates a second-half approval. EVP John Reed added color on broad pipeline momentum in oncology.

Terence Flynn from Morgan Stanley sought clarification on whether commentary about potential Section 232 pharma tariffs targeting generics over biologics was based on specific knowledge or speculation.

Answer

CEO Joaquin Duato emphasized the importance of partnering with the administration to ensure supply chain security. CFO Joseph Wolk clarified that their view was speculative, based on an assessment of national security interests, and that the company remains deferential to the administration's official process.

Terence Flynn asked for an overview of the multiple myeloma franchise's growth prospects for 2025, focusing on the contributions from bispecifics, CAR-T therapies, and the expansion into community settings.

Answer

Jennifer Taubert, an executive, highlighted the franchise's strength, noting DARZALEX's $3.1 billion quarter, CARVYKTI's robust demand and capacity expansion, and the strong performance of TECVAYLI. John Reed, an executive, added that J&J is combining these assets for next-generation frontline therapies, citing promising early data and the potential for CARVYKTI to replace stem cell transplants in earlier lines of therapy.

Terence Flynn from Morgan Stanley asked about the multiple myeloma portfolio, seeking more detail on the drivers of CARVYKTI's strong growth in the second-line setting and what is needed to re-accelerate growth for TECVAYLI.

Answer

Jennifer Taubert, Executive VP of Innovative Medicine, attributed CARVYKTI's 88% growth to strong demand from its CARTITUDE-4 approval, significant overall survival data, and ongoing manufacturing capacity expansion. Regarding TECVAYLI, she noted that while new patient uptake is strong, sequential growth was flat due to longer dosing intervals, but expects future growth from combination studies. John Reed added that TECVAYLI shows best-in-class deep responses.

Terence Flynn inquired about the realistic number of Authorized Treatment Centers (ATCs) Legend Biotech expects to have in the U.S. and globally by 2026, and the ultimate manufacturing capacity beyond the current 10,000 unit target after all ongoing efforts are completed.

Answer

Alan Bash, President of CARVYKTI, reported 132 U.S. sites and over 250 total globally, with plans to expand to 160+ U.S. sites by 2026 and further into the community. He also stated that with all four manufacturing nodes, Legend Biotech aims to eventually reach 20,000 annualized doses through continued ramp-up and efficiency improvements.

Terrence Flynn inquired about Legend Biotech's realistic expansion targets for Authorized Treatment Centers (ATCs) in the U.S. and globally for 2026, and the ultimate manufacturing capacity target beyond the current 10,000 units.

Answer

Alan Bash, President of CARVYKTI, reported 132 ATCs in the U.S. and over 250 globally, aiming for 160+ in the U.S. by 2026. He projected the ultimate manufacturing capacity, leveraging all four nodes (Raritan, Novartis, TechLane, Ovalt), to reach 20,000 annualized doses through ramp-up and efficiency improvements.

Terence Flynn inquired about the potential timing for interim readouts from the CARTITUDE-V and -VI trials and asked for more details on the Virginia Oncology partnership as a template for community oncology expansion.

Answer

Interim Chief Financial Officer Jessie Yeung explained that the trial readouts are event-driven and that discussions with the FDA are ongoing regarding MRD as a dual primary endpoint. Alan Bash, President of CARVYKTI, confirmed the Virginia Oncology partnership serves as a template for community adoption, highlighting the practice's experience and enthusiasm for CARVYKTI.

Terence Flynn inquired about the delay in the BNT323 (TPEM) BLA filing, asking for more color on the gating factors. He also sought clarification on whether the new R&D guidance primarily reflects Bristol-Myers Squibb assuming some BNT327 expenses or other prioritization efforts.

Answer

Ramón Zapata, Chief Financial Officer, clarified that the lower R&D guidance is due to the phasing of certain programs and a deliberate focus on key strategic priorities like BNT327, not solely BMS assuming expenses. Özlem Türeci, Chief Medical Officer and Co-founder, explained the BNT323 BLA submission moved to 2026 due to ongoing discussions with the FDA regarding additional data needs and further analysis for endometrial cancer, unrelated to the breast cancer study.

Terence Flynn inquired about the delay in the BNT323 BLA filing, seeking more color on the gating factor, and asked for clarification on whether the new R&D guidance reflects Bristol Myers Squibb assuming some BNT327 expenses or other prioritizations.

Answer

Ramón Zapata, Chief Financial Officer, clarified that the lower R&D guidance is primarily due to the phasing of certain programs and a deliberate focus on key strategic priorities like BNT327, not a reduction in BNT327 spending or BMS assuming expenses. Özlem Türeci, Chief Medical Officer and Co-founder, explained that the BNT323 BLA submission moved to 2026 due to ongoing discussions with the FDA to understand additional data needs and generate follow-up information, not new data, and this does not change the overall submission strategy.

Terence Flynn inquired about the BNT327 ROSETTA Lung-2 trial, specifically asking about the doses being evaluated in the Phase 2 portion and for confirmation on the timing of the top-line data release.

Answer

Chief Medical Officer Özlem Türeci stated that details on the doses for both the Lung-1 and Lung-2 trials will be disclosed later in the year. She specified that more information on the small cell lung cancer study (Lung-1) would be available in September at the World Conference on Lung Cancer (WCLC).

Terence Flynn requested specific details on the Rosetta Lung studies, including the doses being studied in the Phase II portion, the timing of Phase II data, and the statistical powering of the Phase III portion.

Answer

Chief Medical Officer Özlem Türeci declined to disclose specific doses but indicated trial design details would be presented at upcoming conferences. She stated that Phase II data would be available late 2025 or early 2026 to inform the Phase III portion, which is powered for co-primary endpoints of Progression-Free Survival (PFS) and Overall Survival (OS).

Terence Flynn of Morgan Stanley asked for expectations regarding the upcoming BNT327 Phase II data in small cell lung cancer, specifically what metrics would be presented.

Answer

CSO Ryan Richardson stated the upcoming data will build on previously reported response rates of around 70% and will further validate the move to pivotal trials. CMO Özlem Türeci confirmed the presentation will include follow-up data from an ongoing trial as well as new data from dose justification studies.

Terence Flynn asked for the relevant survival benchmarks for the upcoming BNT327 data in triple-negative breast cancer (TNBC) and whether to expect interim data from the global Phase II lung cancer trial next year.

Answer

CEO Dr. Ugur Sahin and Chief Strategy Officer Ryan Richardson addressed the question. Dr. Sahin noted the comparator is chemotherapy, with a typical PFS of 4-5 months. Mr. Richardson added that pembrolizumab achieved a 15 to 23-month median OS in a similar indication, providing a relevant benchmark. Dr. Sahin also mentioned recently reported PFS data of about 13 months for BNT327.

Terence Flynn from Morgan Stanley asked about the durability of Descovy's robust growth, which is outpacing long-term PrEP market guidance, and requested clarification on the accuracy of IQVIA data for the new Yes2Go launch.

Answer

Chief Commercial Officer Johanna Mercier explained that the overall PrEP market is growing at a strong 15% year-over-year rate due to increased awareness. Descovy's outperformance (35% growth) was driven by improved, unrestricted access, now at 88% of total lives. However, she anticipates a future shift in the product mix as Yes2Go gains traction. Regarding IQVIA data for Yes2Go, Mercier stated it is directionally aligned but still too early to be fully representative, as it doesn't capture all channels, and will require a few more quarters to stabilize.

Terence Flynn of Morgan Stanley asked about the durability of Descovy's strong growth in the PrEP market and requested clarification on the accuracy of third-party IQVIA data for tracking the new Yes2Go launch.

Answer

Chief Commercial Officer Johanna Mercier attributed Descovy's 35% YoY growth to increased PrEP awareness, strong execution, and favorable unrestricted access for 88% of lives. She noted the overall PrEP market is growing at ~15% and expects a future product mix shift as Yes2Go gains traction. Regarding IQVIA data, she stated it is directionally aligned but cautioned it's too early for full accuracy as it doesn't capture all channels.

Terence Flynn asked about the addition of MRD negativity as a dual primary endpoint in the anito-cel Phase III trial and what regulators might require for an approval based on this endpoint.

Answer

Cindy Perettie, Executive Vice President of Kite, explained that MRD negativity is a dual primary endpoint alongside progression-free survival (PFS). She noted that MRD correlates well with PFS and allows for a much earlier assessment of patient response. While not specifying the exact delta required by regulators, she emphasized that the strong correlation between the two endpoints is the basis for their regulatory discussions.

Terence Flynn asked a two-part question regarding 2025 guidance: what revenue, if any, is included for the lenacapavir PrEP launch, and whether the guided margin expansion represents a new steady-state level for future years.

Answer

CFO Andrew Dickinson confirmed the 2025 guidance assumes a mid-year launch for lenacapavir for PrEP, with access ramping over time, but did not provide a specific revenue figure. He affirmed the goal is to hold operating expenses relatively flat for the foreseeable future, allowing top-line growth to drive margin expansion.

Terence Flynn from Morgan Stanley inquired about the mix of background therapy in the TETON study compared to the earlier INCREASE study, particularly regarding TKI use, and how this difference might impact the expected treatment effect.

Answer

Dr. Leigh Peterson, VP of Product Development, confirmed that background therapy use is higher in the TETON studies (around 75-77%) than in INCREASE. She explained that while this can mute an investigational drug's effect, significant room for improvement remains as patients on current therapies still experience FVC decline. This was an expected factor in the trial design and is not a concern.

Terence Flynn from Morgan Stanley asked for perspective on how a potential 15% tariff on pharmaceuticals would impact Merck's 2026 outlook and whether such a tariff would be phased in over time.

Answer

Chairman & CEO Robert Davis stated that while the implementation details are unclear, the impact on 2025 would be minimal due to proactive inventory management and shifting manufacturing to the U.S. He declined to give 2026 guidance but noted significant progress has been made to mitigate future impacts.

Terence Flynn of Morgan Stanley asked for perspective on how a potential 15% tariff on pharmaceuticals would impact Merck's 2026 outlook and whether such a tariff would be phased in or implemented immediately.

Answer

Chairman & CEO Robert Davis stated that it is not yet clear how the tariffs will be implemented. However, he noted that if implemented immediately, the impact on 2025 would be minimal due to proactive inventory management and shifting manufacturing to the U.S. He added that the company has made very good progress on its positioning for 2026 as well.

Terence Flynn asked if the change in the long-term sales outlook for GARDASIL would alter Merck's M&A and business development strategy, specifically regarding the size, type, or cadence of potential deals.

Answer

CEO Robert Davis stated that the M&A strategy remains unchanged, as long-term plans for the post-LOE period never relied on GARDASIL as a primary growth driver. He reiterated that Merck will continue to pursue science-led business development across a full range of opportunities, with a 'sweet spot' of $0-$15 billion, but remains open to larger or commercial-stage assets if they align with strategy and create value.

Terence Flynn of Morgan Stanley asked for clarification on whether the $2-$3 billion GARDASIL forecast for China includes the male opportunity and sought Merck's perspective on emerging data for PD-1/VEGF bispecifics.

Answer

CEO Robert Davis confirmed the $2-$3 billion forecast for China does include the male opportunity. Dr. Dean Li addressed the bispecifics question by highlighting Merck's own significant investments in the VEGF pathway through collaborations and its HIF-2 alpha program. He advised caution when interpreting data from China due to differences in health systems and trial designs.

Terence Flynn asked about Biogen's interactions with the FDA under the new administration and whether the agency might be more favorable towards surrogate endpoints in rare diseases.

Answer

Head of Development Dr. Priya Singhal confirmed they have seen no changes or delays in FDA interactions and have agreement on the Phase III design for their Dravet program. CEO Christopher Viehbacher added that he is encouraged by the new commissioner's focus on innovation for ultrarare diseases and surrogate markers, which could be helpful, though no direct impact has been observed yet.

Terence Flynn asked for directional guidance on operating margins for 2025, including the key factors influencing them.

Answer

CFO Michael McDonnell pointed to significant year-to-date margin improvement. He reiterated the 'Fit for Growth' initiative's goal of $800 million in net savings by the end of 2025. He stated that half of these savings are expected by the end of 2024, with the remaining half to be realized in 2025, which will continue to improve the company's margin profile.

Terence Flynn asked about the next anticipated milestones related to the Regeneron collaboration.

Answer

CEO John Leonard and CFO Edward Dulac explained that a key upcoming milestone is Regeneron's decision on whether to opt into its right for a co-commercialization/co-promotion partnership for nex-Z in the U.S. The timing of this decision is linked to the program's timeline to commercialization, which could be accelerated.

An analyst from Morgan Stanley, on behalf of Terence Flynn, asked for the venue and details of the upcoming casdatifan ARC-20 data presentation and inquired about the applicability of this data to the planned PEAK-1 Phase III trial's patient population.

Answer

COO Jennifer Jarrett stated the venue for the fall presentation would not be disclosed but confirmed it is not ESMO. The update will cover approximately 30 patients with about 10 months of median follow-up. She explained that while the ARC-20 population is more advanced, its positive results are encouraging for the PEAK-1 trial, which will enroll a broader, less advanced patient population.

Inquired about the progress of helping practices with prior inventory at a higher cost and asked about the new mention of bundling DAXXIFY and RHA.

Answer

Mark Foley stated they are the 'majority of the way through' helping accounts with older, higher-cost inventory and expect a 'clean slate' heading into Q2. Regarding bundling, he clarified that nothing has been implemented yet, as they wanted each product to establish its value independently first. However, bundling programs that offer incentives for deeper adoption are planned for later in the year and represent a future growth opportunity.