Geoff Meacham

Geoff Meacham inquired whether Kymera plans to release any interim biomarker or analysis data for the KT-621 Phase IIb BROADEN2 (AD) and BREADTH (asthma) studies, or if results will be held until full unblinding. He also asked how the significant unmet need and less crowded competitive landscape in indications like lupus and Sjögren's influence Kymera's development priorities for the IRF5 program.

Answer

CEO Nello Mainolfi confirmed that Kymera will not release interim data for the KT-621 Phase IIb studies (BROADEN2 and BREADTH) to maintain study integrity, with full results expected upon unblinding. Regarding IRF5, he stated that development priorities are driven by strong human genetics and preclinical data, focusing on high-unmet-need indications like lupus and Sjögren's, with IBD also emerging as a preclinical focus.

Geoff Meacham inquired whether Kymera plans to release interim biomarker data for the KT-621 BROADEN2 and BREADTH Phase 2b studies, or if they will wait for full results. He also asked how unmet needs and less crowded indications like lupus and Sjögren's inform the development priorities for the IRF5 program.

Answer

Nello Mainolfi, Founder, President, and CEO, stated that to protect study integrity, Kymera will wait until the end of the Phase 2b studies to unblind and share data. For IRF5, Nello explained that human genetics, compelling preclinical data, and significant unmet needs in lupus, Sjögren's, myositis, RA, and IBD guide development priorities, particularly highlighting the lack of effective oral therapies in lupus and Sjögren's. He also mentioned IBD as a growing preclinical focus.

Geoff Meacham (question asked by Jarray) asked about the timing for advancing Novavax's shingles and RSV programs into the clinic, questioning if it might extend beyond 2027 to 2028, and whether potential partnerships for these programs could influence their expediency and selection for clinical development.

Answer

President and CEO John Jacobs, Chief Strategy Officer Elaine O'Hara, and Head of R&D Ruxandra Draghia explained that R&D investments support Matrix expansion, new adjuvant creation, and early-stage assets to drive partnering opportunities and generate proof points. They reiterated the goal of advancing one or more assets into the clinic as early as 2027. Programs are selected based on significant market opportunity, unmet medical need, and competitive landscape, with partner discussions initiated as relevant data becomes available.

Geoff Meacham asked about recent FDA interactions regarding KPL-387 and KPL-1161 development, and if there are differences in Arcalyst persistence rates between first recurrence and 2+ recurrence patient populations.

Answer

CEO Sanj Patel emphasized Kiniksa's rigorous development approach. Chief Medical Officer John Paolini detailed productive FDA interactions for KPL-387, confirming the integrated Phase II/III program and the sufficiency of the Phase II trial for U.S. registration. He noted KPL-1161 is still in preclinical development. COO Ross Moat stated no meaningful differences in Arcalyst persistence rates have been observed between first recurrence and 2+ recurrence populations, as both groups generally suffer from chronic multi-year disease.

Geoff Meacham asked about the extent of recent FDA interactions for KPL-387 and KPL-1161, considering potential agency openness to novel designs, and also questioned if there are differences in ARCALYST persistence rates between first recurrence and later recurrence patient populations.

Answer

CEO Sanj Patel emphasized Kiniksa's rigorous approach to development. Chief Medical Officer John Paolini stated that FDA interactions for KPL-387 have been productive, affirming the Phase II trial's pivotal role for U.S. registration, and that KPL-1161 is in preclinical development. COO Ross Moat reported no meaningful differences in ARCALYST persistence rates between first recurrence and 2+ recurrence populations, noting that healthcare professionals are shifting their mindset towards chronic, multi-year disease management with IL-1 alpha and beta inhibition.

Geoff Meacham of Citi asked if dosing and frequency were significant drivers for patient discontinuation of Arcalis, aiming to understand the potential for new patient starts and switches to the next-generation therapy, KPL-387.

Answer

EVP & CCO Ross Moat stated that patient persistence on Arcalis is strong, with an average duration of 30 months and compliance over 85%, indicating dose and frequency are not major issues. CEO Sanj Patel added that while they are excited about KPL-387 and will leverage their commercial experience, its potential is ultimately dependent on clinical trial data.

Geoff Meacham inquired about the payer landscape for povetacicept (pove) in the renal space, including access, reimbursement, and cost-benefit, considering historical challenges in rare renal categories. He also asked about the interest in sweat chloride as a CF biomarker in the U.S. and the willingness to switch to ALYFTREK in Europe versus the U.S.

Answer

Reshma Kewalramani, CEO and President, expressed strong enthusiasm for pove. Duncan McKechnie, EVP and Chief Commercial Officer, noted that physician understanding of sweat chloride as a CFTR function biomarker is similar in the U.S. and Europe, but European dynamics differ due to fewer liver monitoring requirements. He highlighted rapid uptake in treatment-naive patients, such as 1,500 in Italy. For pove, he reported 74 payer engagements covering over 210 million lives since July 2025, with positive and well-informed discussions.

Geoff Meacham asked about the payer landscape for povetacicept in the renal space, specifically regarding access, reimbursement, and cost-benefit, given historical challenges in rare renal categories. He also questioned the interest in sweat chloride as a CF biomarker in the U.S. versus Europe and the willingness to switch to ALYFTREK.

Answer

Duncan McKechnie (Chief Commercial Officer, Vertex Pharmaceuticals) noted that physician understanding of sweat chloride as a CFTR function biomarker is similar across the U.S. and Europe. He highlighted that ALYFTREK's European uptake benefits from fewer liver monitoring requirements and rapid adoption by treatment-naive patients, such as 1,500 newly reimbursed patients in Italy. For povetacicept, he reported 74 payer engagements covering over 210 million lives since July 2025, with positive feedback on IgAN and upcoming products.

Geoff Meacham of Citibank questioned if the chronic pain strategy could expand beyond PNP to areas like joint pain, and asked about the pipeline strategy for NAV1.7 inhibitors following the VX-993 data.

Answer

President and CEO Dr. Reshma Kewalramani clarified the focus remains on neuropathic pain first, with musculoskeletal pain as a future possibility but not a current high priority. She emphasized that the next major step in acute pain is advancing a NAV1.7/1.8 combination therapy, which has shown synergistic effects preclinically.

Geoff Meacham asked about the sustainability of Royalty Pharma's dividend and buyback program for 2026, questioning if capital could be better spent on royalty deals and how the deployment mix might evolve. He also inquired about creative ways for Royalty Pharma to get more involved in private companies, crossovers, or IPOs given the thawing capital markets, and how the returns there compare to more mature processes.

Answer

Terry Coyne, EVP and CFO, explained that the dynamic capital allocation framework balances royalty opportunities against stock valuation. He noted that share repurchases were accelerated when the stock was attractive and dialed back as deal activity picked up, indicating a current bias towards royalty investments. Chris Hite, EVP and Vice Chairman, stated that Royalty Pharma is focused on high-quality biopharmaceutical products, regardless of whether they are housed within private companies, and that the growth of their opportunity set is robust in any capital market environment.

Geoff Meacham asked about the sustainability of Royalty Pharma's dividend and buyback strategy for 2026, questioning if capital could be better spent on royalty deals, and inquired about creative ways for Royalty Pharma to engage with private companies, crossovers, or IPOs given the thawing capital markets.

Answer

Terry Coyne, EVP, Chief Financial Officer, explained that capital allocation is dynamic, balancing royalty opportunities with stock valuation, noting accelerated share repurchases when the stock was attractive and increased royalty investments when deal activity picked up. Chris Hite, EVP, Vice Chairman, added that Royalty Pharma focuses on high-quality biopharmaceutical products regardless of whether they are housed within private or public companies, and is excited about the growing opportunity set in any capital market environment.

Geoff Meacham inquired if an anticipated uptick in IRR, driven by new launches, would alter Royalty Pharma's willingness to invest in moderately earlier programs or take on bigger risks, acknowledging that the core model would not materially change.

Answer

Pablo Legorreta, CEO and Chairman, stated that the movement of IRR calculations does not impact their behavior, as they pursue attractive transactions regardless of development stage. Terry Coyne, EVP and CFO, emphasized the stability and consistency of their return on invested capital (ROIIC) and return on invested equity (ROE) metrics, expecting ROIIC to remain in the mid-teens, which reflects the value creation of their business model.

Geoff Meacham inquired whether an anticipated increase in the Internal Rate of Return (IRR) as new launches hit a tipping point would influence Royalty Pharma's willingness to consider moderately earlier programs or take on greater risks in their investment strategy.

Answer

Pablo Legorreta, CEO and Chairman, stated that while they track IRR for decades, it doesn't significantly alter their behavior; they pursue attractive transactions regardless of whether they are approved or in development. Terry Coyne, EVP Chief Financial Officer, emphasized the stability and consistency of their return on invested capital and equity metrics, expecting them to remain in the mid-teens range for invested capital, reflecting the business model's value creation.

Geoff Meacham of Citigroup requested an updated view on the potential impact of US policy changes like MFN and PBM reform, and also asked about the current level of interest in large-scale (>$1B) deals and the strategic priority of synthetic royalties.

Answer

Head of Research & Investments Marshall Urist explained the company uses a scenario-based approach for new investments to account for policy uncertainty and focuses on high-impact medicines. CEO Pablo Legorreta confirmed continued opportunities for large, billion-plus deals, noting they are becoming more common annually and highlighting new sources like out-licensing from China. He also reiterated the importance of synthetic deals.

Geoff Meacham asked about Gilead's M&A strategy, potential pipeline voids, and the urgency for larger-scale business development given recent launches and pipeline strength.

Answer

Daniel O'Day, Chairman and CEO, highlighted Gilead's robust internal portfolio with up to 10 launches by 2027 and 5 Phase 3 readouts across all therapeutic areas. He noted ongoing early-stage transactions (approximately $1 billion annually) and a disciplined, proactive approach to later-stage acquisitions. Given the strong pipeline and no major LOEs until 2036, he indicated less urgency for large deals compared to other companies. Andrew Dickinson, CFO, added that corporate development historically drives growth, and they seek synergistic, de-risked late-stage assets to further accelerate top-line and bottom-line growth, while maintaining discipline.

Geoff Meacham asked about Gilead's broader M&A strategy, specifically what voids the company aims to fill, whether it's further therapeutic diversification or a new product cycle for the mid-2030s, and the current urgency for business development.

Answer

Daniel O'Day, Chairman and CEO, and Andrew Dickinson, CFO, responded. Dan highlighted Gilead's robust internal portfolio, with up to 10 ongoing or planned launches by 2027 and no major LOEs until 2036, built through original research, early-stage partnerships, and M&A. He noted Gilead spends approximately $1 billion annually on earlier-stage transactions across therapeutic areas. While proactive and disciplined in later-stage acquisitions, the company does not have the same urgency as others in the sector due to its strong pipeline, but still aims to add appropriate M&A over time. Andy added that M&A historically drives a reasonable portion of growth and they seek synergistic, de-risked late-stage assets to turbocharge growth.

Geoff Meacham of Citigroup inquired about the ex-U.S. market potential for Yes2Go, asking if its contribution could be larger than that of Descovy and eventually mirror the revenue split seen in HIV treatment.

Answer

Chief Commercial Officer Johanna Mercier agreed that Yes2Go has a broader ex-U.S. opportunity than Descovy, which faced generic competition. She believes the innovative profile of Yes2Go will appeal to countries aiming to meet HIV prevention goals. While acknowledging reimbursement will be a challenge, she sees a clear path to partner with stakeholders and achieve a wider international footprint than with previous PrEP options.

Geoff Meacham of Citigroup asked about the international (OUS) market potential for Yes2Go, suggesting its contribution could be larger than that of Descovy and questioning if the PrEP U.S. vs. OUS revenue split could eventually mirror HIV treatment.

Answer

Chief Commercial Officer Johanna Mercier agreed that Yes2Go has a broader ex-U.S. opportunity than Descovy, which faced generic Truvada competition internationally. She noted that Yes2Go's innovation is a compelling value proposition for countries with high HIV incidence that are struggling to meet 2030 prevention goals. While acknowledging that securing reimbursement will take time and effort, Mercier sees a clear opportunity to partner with international stakeholders and achieve a wider footprint than with previous PrEP options.

Geoff Meacham asked about the HIV treatment pipeline, specifically the key factors for selecting a long-acting oral Phase III combination and whether a three-drug regimen is necessary given lenacapavir's high barrier to resistance.

Answer

Chief Medical Officer Dietmar Berger responded that the primary goal of the development program is to provide optionality with weekly and monthly oral regimens. While not detailing the specific criteria for combo selection, he emphasized the breadth of the portfolio and the immediate focus on the near-term lenacapavir for PrEP launch and the potential for a once-yearly formulation.

Geoff Meacham asked about Cobenfy's sales inflection, inquiring if there's an access bottleneck and what steps are needed for sequential acceleration. He also questioned the dataset tipping point for scaling Phase III investment in Fumitomab and the upper end of its Phase III studies or tumor types capacity.

Answer

Adam Lenkowsky (Executive Vice President and Chief Commercial Officer, Bristol Myers Squibb) reported strong progress for Cobenfy with over 100,000 TRXs since launch, robust access, and accelerating new prescriptions in Q4, expecting continued steady growth with new indications driving future inflections. Cristian Massacesi (Executive Vice President, Chief Medical Officer, and Head of Global Drug Development, Bristol Myers Squibb) expressed high confidence in Fumitomab, citing active datasets in triple-negative breast cancer and non-small cell lung cancer, and its validated targets. He confirmed scaled development with 7-8 pivotal studies across multiple indications, aiming to replace and expand PD-1/PD-L1 inhibitors.

Geoff Meacham inquired about the lack of an inflection point in Cobenfy sales, asking if access is a bottleneck and what steps are needed for sequential acceleration. He also asked about Fumitomab, specifically if a dataset tipping point is needed before scaling Phase III investment and the upper limit of studies/tumor types.

Answer

Adam Lenkowsky, Executive Vice President and Chief Commercial Officer, stated that Cobenfy's strong access (nearly 100% Medicaid/Medicare, 70% commercial) is not a bottleneck. He noted progress in Q4 with accelerated new prescriptions and trialists, expecting continued steady growth, with new indications driving future inflections. Cristian Massacesi, Executive Vice President, Chief Medical Officer, and Head of Development, expressed high confidence in Fumitomab due to existing datasets and validated targets. He confirmed scaled-up development with seven pivotal studies across multiple indications (non-small cell lung cancer, gastric, colon, head and neck, breast), aiming to replace and expand PD-1/PD-L1 inhibitors.

Geoff Meacham inquired about the commercial performance of Cabenfi, specifically characterizing the speed of reimbursement and depth of prescribers in the U.S., and identifying potential tipping points for demand. He also asked Christian Masetti about his early priorities and approach to developing Bristol Myers Squibb's diversified portfolio.

Answer

Adam Lenkowsky, Chief Commercialization Officer, expressed satisfaction with Cabenfi's progress, noting over 2,400 weekly TRXs, a significant number of new trialists, positive physician feedback, and nearly 100% Medicare/Medicaid access. He highlighted the need to increase prescribing breadth and depth, with an expanded field force, and anticipated long-term growth fueled by additional indications. Cristian Massacesi, Chief Medical Officer and Head of Global Drug Development, outlined his priorities: evolving the development organization to deliver on the pipeline by focusing on strong science, flawless execution, and patient/company value; integrating new ways of working with AI and novel tools; and building strong teams and attracting talent.

Geoff Meacham asked about the commercial performance of COBENFY, specifically characterizing the speed of reimbursement and depth of prescribers in the U.S., and identifying potential tipping points for demand. He also asked CMO Christian Massacesi about his priorities and approach to developing Bristol Myers Squibb's diversified portfolio.

Answer

Chief Commercialization Officer Adam Lenkowsky reported positive progress for COBENFY, surpassing 2,400 weekly TRXs and achieving nearly 100% access in Medicare/Medicaid. He noted the need to increase prescriber breadth and depth, with an expanded field force in place. CMO Christian Massacesi highlighted his focus on strong science, portfolio potential, flawless execution, integrating new technologies like AI, and building strong teams.

Geoff Meacham of Citigroup Inc. inquired about recent Phase III trial disappointments, asking if any of the data could still support label expansions or offer a faster path to new indications.

Answer

CEO Chris Boerner responded that these specific studies have limited impact on the company's long-term growth and have no read-forward implications for other pipeline assets. EVP & Chief Medical Officer Samit Hirawat added that for some trials, like Reblozyl's 'independence' study, the company sees clinically meaningful impact and plans to engage with global health agencies.

Geoff Meacham from Citi inquired about Eli Lilly's strategy for Zepbound combination therapies in immunology, oncology, or neuroscience, specifically asking what drives investment priorities and the path to potential labeling claims.

Answer

Adrienne Brown, President of Lilly Immunology, highlighted the significant opportunity in immune diseases, especially for patients with comorbid obesity, and the potential for better, longer-lasting results with combination therapies. She mentioned ongoing trials like TOGETHER PSO (Taltz + Zepbound in psoriasis), TOGETHER-Amplify-PsA/PSO (adding Zepbound after Taltz), and COMMIT studies (Omvoh + Zepbound in UC/Crohn's), as well as a Phase II study of Brenipatide in asthma, all aimed at exploring incretins' applications in immune diseases. Mike Czapar, SVP of Investor Relations, directed the question.

Geoff Meacham asked about Lilly's strategy for combination therapies involving Zepbound with immunology/inflammation (I&I), oncology, or neuroscience, inquiring whether investment priorities are driven by the drug or the indication and the potential for labeling claims.

Answer

Adrian Brown, President of Lilly Immunology, highlighted the significant opportunity in immune diseases, especially for patients with comorbid obesity, to combat inflammation and achieve better, longer-lasting results. She mentioned ongoing broad efforts, including the TOGETHER-PSO trial (Taltz + Zepbound for psoriasis), TOGETHER-Amplify-PsA and TOGETHER-Amplify-PSO studies (adding Zepbound after Taltz), phase 3b COMMIT studies (Omvoh + Zepbound for ulcerative colitis and Crohn's disease), and a phase 2 study of Brenepatide for asthma.

Geoff Meacham asked about the commercial strategy for orforglipron, specifically whether it will be more consumer-centric through Lilly Direct or follow a typical pharma launch with critical PBM and payer negotiations, and the pros and cons of each approach.

Answer

Ilya Yuffa, President of Lilly USA and Global Customer Capabilities, expressed excitement for orforglipron's commercialization, noting a dual approach similar to Zepbound. This involves driving broad commercial access while also leveraging direct-to-consumer platforms like Lilly Direct to meet significant consumer demand and overcome healthcare system frictions, ensuring patient accessibility.

Geoff Meacham inquired about the commercial strategy for orforglipron, specifically whether it will be more consumer-centric through Lilly Direct or follow a traditional pharma launch model with PBM and payer negotiations.

Answer

Ilya Yuffa, President of Lilly USA and Global Customer Capabilities, indicated a dual approach similar to Zepbound, focusing on both broad coverage and expanding direct-to-consumer platforms like Lilly Direct to address significant consumer demand and reduce healthcare system friction.

Geoff Meacham of Citigroup Inc. asked about the gastrointestinal (GI) adverse event profile for orforglipron, specifically how the rates changed over the course of the studies and if there were common features among patients with higher AE rates.

Answer

Dr. Daniel Skovronsky, Chief Scientific Officer, explained that the GI profile was consistent with the GLP-1 agonist class, with no surprises. He noted that side effects were most common early in treatment or after dose escalations and then subsided over time. He also stated that no specific patient characteristics were identified that predicted higher adverse event rates.

Geoff Meacham questioned the feasibility of extending the dosing interval for 3944 beyond monthly, based on its PK/PD profile, and asked about Pfizer's phase III plans, specifically whether they would be standard metabolic studies or include inflammation/neuropsych indications, or GLP-1 active comparator studies for differentiation.

Answer

Chief Scientific Officer Chris Boshoff confirmed that 3944 is aimed at monthly maintenance, but mentioned another phase I peptide with potential for three-monthly administration. He outlined initial phase III programs (VESPER-4, -5, -6) for patients with and without type 2 diabetes, and monthly dosing, and indicated that beyond cardiovascular and metabolic, Pfizer is exploring other opportunities for differentiation, including combinations with amylin or the GLP antagonist.

Geoff Meacham asked for a ranking of priorities between manufacturing investments related to the MFN agreement and operational cost efficiencies, given both initiatives have three-year timeframes.

Answer

Dave Denton, CFO, Pfizer, stated that both manufacturing investments in the U.S. and operational cost efficiencies are important strategic elements. He clarified that these two priorities are not in conflict and Pfizer expects to improve its manufacturing operating infrastructure while simultaneously investing in U.S. manufacturing capacity. Albert Bourla, Chairman and CEO, Pfizer, also contributed.

Geoff Meacham asked about the prioritization of manufacturing investments related to the MFN agreement versus operational cost efficiencies, both having three-year timeframes, seeking clarity on the strategic allocation of resources.

Answer

Dave Denton, CFO, affirmed both are important elements of Pfizer's strategy. He stated that Pfizer would invest in U.S. production as per the MFN agreement and would provide more details with the 2026 guidance. He emphasized that improving manufacturing infrastructure and investing in U.S. manufacturing are not in conflict and can be achieved simultaneously.

Geoff Meacham asked about real-world trends for Winrevair, including duration of therapy, safety, and tolerability, compared to Phase III data, and how Merck is considering related pulmonology indications where the mechanism might have an impact.

Answer

Dean Li, President of Research Laboratories, Merck & Co. Inc, stated that Winrevair is reshaping the standard of care in PAH due to its differentiated mechanism, with positive feedback on sustainability and cardiac remodeling. Rob Davis, Chairman and CEO, Merck & Co. Inc, added that over 110,000 prescriptions have been dispensed to over 9,100 patients, with high compliance and discontinuation rates in line with or better than other PAH products. The safety profile remains consistent with the label and across all studies. Dean Li also discussed exploring other pulmonary indications where the mechanism could impact right heart stress, including those related to connective tissue disorders and pulmonary fibrosis.

Geoff Meacham asked about Winrevair's real-world trends, including duration of therapy and safety/tolerability, after two years on the market, and Merck's thinking on related pulmonology indications where the mechanism might have an impact beyond the Cadence study.

Answer

Dean Li, President of Research Labs, highlighted Winrevair's role in reshaping PAH standard of care due to its differentiated mechanism, comparing its impact to ACE inhibitors in left heart failure. He noted positive feedback from sites on sustainability and cardiac remodeling. Rob Davis, Chairman and CEO, added that over 110,000 prescriptions had been dispensed, with over 9,100 patients starting therapy, and compliance and safety profiles consistent with expectations and the label across multiple studies. Dean Li also mentioned ongoing discussions about other pulmonary indications and connective tissue disorders.

Geoff Meacham asked about EYLEA HD's growth trends for 2026, focusing on sources like new patients, switches, and competition, and whether the potential prefilled syringe approval would be a 'tipping point' for demand.

Answer

Marion McCourt, Executive Vice President of Commercial, Regeneron Pharmaceuticals, stated that EYLEA HD is making good progress, with recent label enhancements (Q4 weekly dosing and RVO) being well-received. She noted that while many users exist, the prefilled syringe would offer additional convenience for offices, further enhancing its profile and potentially increasing demand.

Geoff Meacham asked about the growth trends for EYLEA HD in 2026, focusing on sources like new patients, switches, and competition, and whether the potential approval of a prefilled syringe would serve as a 'tipping point' for demand.

Answer

Marion McCourt, Executive Vice President of Commercial, Regeneron Pharmaceuticals, noted good progress with EYLEA HD and positive reception for recent label enhancements. She stated that while the prefilled syringe would offer convenience and further enhance the product's profile, EYLEA HD already has many users, and its adoption is expected to improve further with the syringe.

Geoff Meacham from Citigroup Inc. asked about the ROI calculus for prioritizing Regeneron's 45 development assets and whether out-licensing non-core assets is a reasonable consideration.

Answer

President & CEO Dr. Leonard Schleifer affirmed that internal R&D offers the greatest potential return. However, he stated the company is not structurally opposed to out-licensing or partnerships for non-core assets, citing the past deal for its IL-1 blocker as an example, but would avoid it for assets with combination potential.

Geoff Meacham from Citigroup asked about the return on investment calculus for Regeneron's 45-asset pipeline and whether out-licensing non-core assets is a reasonable strategy to consider.

Answer

President & CEO Dr. Leonard Schleifer affirmed that while internal R&D offers the greatest potential return, the company is not structurally averse to out-licensing or partnering non-core assets, citing the IL-1 blocker as a successful past example. He noted they would be less likely to partner assets intended for internal combination therapies.

Geoff Meacham (Citigroup) asked if Moderna's pipeline evaluation process has evolved to maximize ROI on R&D investments, especially in light of cost reductions and the 2028 break-even target. He also questioned the capacity of the rare disease platform to add more programs, comparing its potential speed to proof-of-concept data with oncology.

Answer

President Stephen Hoge explained that the pipeline construction is "cash and investment optimizing" rather than strictly ROI maximizing, with large Phase 3 infectious disease investments deferred until after 2028 cash break-even. He noted that attractive ROI opportunities in oncology (IntiSPOTRAN, mRNA 4359) and rare diseases (PA, MMA) are being pursued within the break-even guidance. He indicated that further rare disease investments would likely wait until PA and MMA registrational studies are complete and break-even targets are met.

Geoff Meacham asked about the evolution of Moderna's pipeline evaluation process to maximize ROI on R&D investments, particularly in the context of the 2028 break-even target. He also inquired about the capacity within the rare disease platform to add more programs, comparing it to oncology and the company's strategic thinking.

Answer

Stephen Hoge, President, explained that Moderna has deferred further large Phase 3 investments in infectious disease until after the 2028 cash break-even, focusing on cash and investment optimization rather than pure ROI maximization for those programs. He noted that oncology investments (e.g., IntiSPOTRAN, mRNA 4359) are proceeding due to attractive ROI and fit within break-even guidance. For rare diseases, while the platform has potential, further investments beyond PA and MMA are being disciplined until break-even is achieved, balancing against future oncology or infectious disease pivotal investments.

Geoff Meacham asked if AbbVie expects a formal agreement with the administration on policy issues like Medicaid and U.S. manufacturing, and what leading indicators suggest a rebound in the aesthetics market.

Answer

Rob Michael, Chairman and CEO, confirmed ongoing engagement with the administration on patient access, affordability, and U.S. innovation leadership, aligning on addressing global freeloading, expanding direct-to-patient models, and U.S. manufacturing investments. He noted ELAHERE's U.K. list price matching the U.S. as aligned with administration goals. Jeff Stewart, Executive Vice President, Chief Commercial Officer, identified consumer confidence, middle-income consumer posture for new toxin treatments, and stabilization of HA filler sentiment as leading indicators for an aesthetics market rebound, with TrenibotE expected as a significant catalyst next year.

Geoff Meacham asked about AbbVie's engagement with the administration on policy matters like Medicaid and U.S. manufacturing, and for leading indicators of a rebound in the aesthetics market given ongoing macro headwinds and recent commercial investments.

Answer

Chairman and CEO Rob Michael confirmed active engagement with the administration on patient access, affordability, and U.S. innovation leadership, citing efforts to address global freeloading, expand direct-to-patient models, and invest in U.S. manufacturing. EVP and CCO Jeff Stewart identified consumer confidence, middle-income consumer posture, and stabilization of HA filler sentiment as key indicators for an aesthetics market rebound, noting continued investment and future product launches like Trinavut E.

An analyst on for Geoff Meacham at Citigroup asked for more color on the types of patients represented in the early Sefiance scripts and whether they were coming in voluntarily or during scheduled visits. They also inquired about the FDA's stance on a broad label for vutiquinone and if labeling discussions had begun.

Answer

CEO Dr. Matthew Klein stated that while it's early, there are no clear patterns for incoming Sefiance scripts, other than broad interest from a mix of patient types, consistent with expectations. He noted many centers are working through patient waitlists. For vutiquinone, he said the data package supports a broad label across all age groups and disease severities, but formal labeling negotiations with the FDA have not yet started.

Geoff Meacham asked if any changes were made to the Meritide Phase 3 program following the ADA conference and whether the current trials represent the bulk of the investment or if expansion into other indications is planned.

Answer

James Bradner, EVP of R&D, confirmed no changes were made, citing positive feedback and strong enrollment. He also indicated interest in exploring other obesity-related conditions. Murdo Gordon, EVP of Global Commercial Operations, added they will continue generating data to inform clinical practice.