Evan Seigerman

Evan Seigerman from BMO Capital Markets asked for more details on the anticipated evolution of Schrödinger's customer split as the company works towards its annual software ACV growth goal of 10%-15% by 2028. He specifically inquired about how a gradually improving biotech funding environment and the introduction of newer products might impact this customer segmentation.

Answer

Ramy Farid, CEO, explained that while the company is not providing specific ACV growth guidance for each segment, they anticipate a recovery in biotech funding and expect tailwinds from the broader adoption of agentic AI. He noted that new products being released this year are expected to impact all segments, including both life sciences and material science, contributing to overall ACV growth.

Evan Seigerman of BMO Capital Markets inquired about the current tone of customer conversations regarding platform investment and the strategic rationale for out-licensing the SGR-1505 program at the Phase 1 stage.

Answer

CEO Ramy Farid confirmed that customer discussions remain positive with strong demand for predictive technologies despite macroeconomic headwinds. Karen Akinsanya, President and Head of Therapeutics R&D, explained that SGR-1505 is best advanced by a partner with late-stage hematology development and commercialization expertise to accelerate the program and maximize its potential.

Evan Seigerman asked what could potentially change the positive sentiment among pharma partners regarding platform investment. He also requested a summary of Schrödinger's contributions toward the FDA's goal of reducing animal testing.

Answer

CEO Ramy Farid explained that customer sentiment is driven by demonstrated impact, with success at early adopters now influencing broader industry adoption. He highlighted the company's predictive tox initiative and existing solutions for properties like bioavailability and off-target binding (e.g., hERG) as key contributions to reducing animal testing.

Evan Seigerman of BMO Capital Markets asked about P&L management amid advancing clinical programs and the go/no-go efficacy bar for moving beyond Phase I.

Answer

CFO Geoff Porges addressed P&L management, stating a focus on reducing OpEx growth to achieve operating leverage. He clarified that the company does not plan to advance all portfolio assets on its own. President of R&D Karen Akinsanya added that the efficacy bar for MALT1, CDC7, and Wee1 is evidence of monotherapy activity, which is crucial before exploring combinations.

Evan Seigerman sought clarification on the rationale for studying povetacicept (pove) in generalized myasthenia gravis (gMG), its differentiating factors, observations from earlier studies, and how it compares to existing and investigational treatments.

Answer

Reshma Kewalramani, CEO and President, highlighted gMG as a sizable population (nearly 200,000 in U.S. and Europe) and a clear B cell-mediated disease. She noted limitations of current therapies, such as cyclical administration leading to disease relapse. She referenced a China-based study using a wild-type TACI, which showed remarkable improvements in the myasthenia gravis ADL score, suggesting the mechanism of action is transformative. Pove, as an engineered fusion protein with improved potency and pharmacokinetics, is expected to offer best-in-class potential, with a Phase II dose-ranging study (80 mg and 240 mg) planned for early 2026.

Evan Seigerman requested an expansion on the rationale for studying povetacicept in generalized myasthenia gravis (gMG), particularly its differentiation in a crowded rare disease space and how it compares to existing and investigational therapies.

Answer

Reshma Kewalramani (CEO and President, Vertex Pharmaceuticals) highlighted gMG as a sizable B-cell-mediated disease with approximately 200,000 patients in the U.S. and Europe. She noted that current therapies have limitations, such as cyclical administration leading to disease relapse. She referenced a China-based study using a wild-type TACI, which showed remarkable efficacy on the myasthenia gravis ADL score, and explained that povetacicept, as an engineered fusion protein, offers superior potency, binding affinity, pharmacokinetics, and tissue distribution, positioning it for best-in-class potential.

Evan Seigerman from BMO Capital Markets asked for the rationale behind prioritizing specific indications like gMG and WAHA for povetacicept, questioning whether the driver was clinical, preclinical, or commercial factors.

Answer

President and CEO Dr. Reshma Kewalramani responded that the decision was based on "all of the above," including emerging data from Vertex's own studies, promising data from the drug class, high unmet need, the potential for a transformative medicine, and strong commercial opportunity.

Evan Seigerman asked about the key hurdles preventing a faster acceleration in CASGEVY uptake, questioning if factors like fertility concerns, health system trust, or procedure intensity were primary obstacles and how Vertex plans to overcome them.

Answer

COO Stuart Arbuckle responded that CASGEVY uptake did accelerate in Q1. He attributed this to progress in activating authorized treatment centers (ATCs), securing broad reimbursement in the U.S. and increasingly ex-U.S., and growing physician familiarity with the treatment process. He noted that multiple ATCs have now treated several patients, which is building confidence and momentum.

Evan Seigerman asked about the progress of early payer discussions for JOURNAVX, inquiring about the expected number of covered lives at launch and how that figure is anticipated to grow throughout the year.

Answer

COO Stuart Arbuckle reported that payer discussions have been very positive due to the high unmet need for non-opioid pain options. While he expects broad access to grow over time, he stated that Vertex is not providing specific guidance on the number of covered lives at particular points during the year.

Evan Seigerman of BMO Capital Markets asked about the key learnings from the first commercial patient to complete the full CASGEVY process, focusing on what went well and what areas might be optimized for future patients.

Answer

COO Stuart Arbuckle shared that the experience reinforced the understanding that this is a significant and lengthy journey for patients. He highlighted strong enthusiasm from Authorized Treatment Centers (ATCs) and noted that payer excitement has translated into favorable access, with reimbursement not being a significant barrier in the U.S.

Evan Seigerman inquired about Incyte's strategy to manage the placebo response in the Phase III HS data for OPZELURA, particularly given its testing in a mild to moderate patient population where placebo effects can be exaggerated.

Answer

Steven Stein, CMO, Incyte, explained that placebo response is being managed through larger study sizes (greater N), setting minimum requirements for abscess and nodules, and focusing on higher HiSCR control rates (HiSCR 75) across two studies.

Evan Seegerman asked about Incyte's strategy for managing the placebo response in the phase 3 HS data for Opzelura, particularly given its testing in a mild to moderate patient population where placebo effects can be more pronounced.

Answer

Steven Stein, CMO, outlined several strategies to manage placebo response, including conducting larger studies with a greater patient enrollment, setting minimum requirements for abscess and nodules to prevent artificial placebo effects, and focusing on higher rates of HiSCR control, such as HiSCR 75, across two studies.

Evan Seiderman asked how the current pipeline needs to mature to drive growth through the Jakafi LOE, what type of business development would supplement that growth, and what Incyte looks like with and without mCALR by the end of the decade.

Answer

CEO Bill Meury outlined seven key drivers: Povorcitinib (three indications, dermatology franchise), 989 (mCALR), 617F (mCALR bispecific, potentially 2X 989's size), three solid tumor programs (KRAS G12D, TGF-beta by PD-1, CDK2), and Naktinvo (two combination trials). He emphasized that not all need to work, but 2-3 hits from these seven could build a business larger than the current one post-2029. He stated he could not exclude mCALR from the picture due to its importance.

An analyst on behalf of Evan Seigerman asked for quantification of Opzelura's Q1 inventory reduction impact and for commentary on the progression of U.S. usage, particularly tubes per patient.

Answer

CFO Christiana Stamoulis stated that U.S. paid demand for Opzelura grew 24% while net revenue grew 20%, with the difference from an inventory reduction after a Q4 build. An executive added that they expect overall utilization to increase from both new prescriptions and greater use among the existing patient base.

Evan Seigerman of BMO Capital Markets asked for the initial assumptions for the pediatric Opzelura launch, including the expected uptake curve and its contribution to guidance. He also posed a hypothetical question about whether Incyte would consider a head-to-head trial of povorcitinib versus adalimumab in HS.

Answer

Matteo Trotta, EVP, Global Head of Hematology and Oncology, stated that at peak, the pediatric atopic dermatitis indication is expected to represent 10-15% of the total Opzelura AD business. Pablo Cagnoni, President, Head of R&D, responded that there are no current plans for a head-to-head HS trial, noting the significant real-world dissatisfaction with Humira creates a large opportunity for new therapies.

Evan Seigerman from BMO Capital Markets asked about the company's confidence in the upcoming Q4 readout for the ALK2 inhibitor program, noting its previous ups and downs despite a strong mechanistic rationale.

Answer

Steven Stein, an executive, explained that the program has required escalating to higher doses to achieve the desired effect on hepcidin and hemoglobin. He stated that to date, they have not seen sufficient efficacy to trigger a go-decision for a future registration program. He confirmed more data would be shared by the end of the year.

Evan David Seigerman inquired about the potential impact of high-dose Spinraza's anticipated U.S. approval in April on Biogen's 2026 rare disease top-line growth.

Answer

Christopher A. Viehbacher, President and CEO, Biogen, noted that early signs from the Japan launch (the first country to approve) show higher initial results and switchbacks, exceeding expectations. He highlighted the significantly increased efficacy observed in studies, which could make the choice between oral convenience and Spinraza's efficacy harder for physicians and parents. While market research suggests sales increases, he emphasized the need to observe actual sales and physician willingness to transition patients, but sees an opportunity for upside.

Evan Seigerman asked about the potential impact of the high-dose Spinraza approval in the U.S., expected in April, on Biogen's 2026 rare disease top-line growth.

Answer

Christopher A. Viehbacher, President and CEO of Biogen, reported encouraging early results from Japan's launch of high-dose Spinraza, exceeding initial expectations in adoption and switchbacks due to higher efficacy. He noted that while convenience of oral competitors is a factor in the SMA market, the dramatically increased efficacy of high-dose Spinraza could make the choice more difficult for physicians and parents. He indicated market research suggests potential sales increases, but the speed of physician transition remains to be seen. He emphasized that it is an important launch, highly anticipated by both patient advocacy groups and the medical community.

Evan Seigerman asked how the potential for at-home administration with the LEQEMBI subcutaneous formulation could accelerate U.S. sales and what hurdles remain.

Answer

CEO Christopher Viehbacher detailed that the subcutaneous option will first support the maintenance phase, enhancing long-term adherence for patients. For initiation, it will significantly reduce the burden on infusion centers and simplify the physician's workload, especially in rural areas. He positioned it as a key enabler for both patients and physicians, simplifying logistics and improving access.

Evan Seigerman asked for Biogen's perspective on the use of GLP-1s in Alzheimer's disease and how a positive trial result from a competitor could impact the standard of care.

Answer

Dr. Priya Singhal, Head of Development, acknowledged the scientific hypothesis but pointed to past trial failures in the space. She emphasized that tackling the core amyloid pathology is critical and expressed confidence that LEQEMBI, as an anti-amyloid agent, will continue to play an important role in treatment regardless of outcomes from other mechanistic approaches.

Evan Seigerman asked about the path for SPINRAZA to return to growth, given softer Q3 results, and whether this depends on the high-dose nusinersen formulation.

Answer

CEO Christopher Viehbacher noted that excluding a one-time Russian tender, the brand grew globally. Alisha Alaimo, President of North America, added that U.S. growth remains strong, driven by efficacy, patient switchbacks, and new patient finds. Both executives emphasized that the high-dose version, with its faster therapeutic benefit, is a key future growth driver.

Evan Seigerman followed up on diversification and segmentation, asking how Novo Nordisk plans to prevent a 'race to the bottom' in the obesity market and ensure appropriate pricing. He also questioned whether the company should lean more into rare diseases and cardiometabolic adjacencies to expand its footprint.

Answer

CSO Martin Holst Lange explained that while there's a consumer space focused on weight loss, there's also a segmentation for subpopulations with high weight loss needs or comorbidities like MASH and cardiovascular disease. In these higher-value, potentially lower-volume segments, Novo Nordisk can develop specific innovations and justify higher prices by demonstrating return on investment to payers. CEO Mike Doustdar added that competition is not just with other pharma but with alternatives like liver transplants, and success depends on scaling and portfolio breadth, similar to their diversified insulin business.

Evan Seigerman questioned how Novo Nordisk plans to prevent a 'race to the bottom' in the obesity market and ensure appropriate segmentation and pricing, especially given competition from compounded products. He also asked if the company should lean more into rare diseases and cardiometabolic adjacencies to expand its footprint.

Answer

CSO Martin Holst Lange explained that while there's a consumer space focused on weight loss, there's also a segmentation for subpopulations with high weight loss needs or comorbidities like MASH, where higher value and different pricing are possible. CEO Mike Doustdar added that pricing depends on competitors (e.g., liver transplant for Efruxifermin) and that market perception and brand matter beyond simplistic efficacy. He emphasized the importance of scale and a broad portfolio with different product presentations and form factors, drawing parallels to Novo Nordisk's diversified insulin business.

Evan Seigerman of BMO Capital Markets asked for the rationale behind discontinuing the development of sufi-fermin for NASH and whether the company maintains interest in the FGF21 drug target.

Answer

Martin Lange, EVP of Development, explained the asset was discontinued because it failed to demonstrate a meaningful efficacy benefit over semaglutide, which he described as a powerful and difficult-to-beat agent in NASH. He added that while this specific asset did not advance, the company is not necessarily finished with the FGF21 biology.

Evan Seigerman questioned the potential manufacturing capacity increase from the three acquired Catalent facilities and the resulting impact on product supply by 2026.

Answer

Karsten Knudsen, Group's CFO, described the acquisition as a "meaningful step-up" in overall fill-finish capacity, crucial for speed and scale. He emphasized the strategic importance of bringing the single-dose syringe platform in-house, which enhances control over a key part of the supply chain for products like Wegovy in the U.S.

Evan Seigerman asked about the key metrics Lilly would track for a successful Orforglipron launch a year from now, seeking qualitative commentary on market expansion, patient satisfaction, and real-world efficacy.

Answer

Ken Custer, President of Lilly Cardiometabolic Health, expressed excitement for Orforglipron's global launch. He highlighted market expansion, driven by new oral option seekers, and the drug's competitive profile, emphasizing patient satisfaction and real-world efficacy due to its simple regimen without food/water restrictions.

Evan Seigerman from BMO Capital Markets inquired about the qualitative metrics and success factors Eli Lilly would use to characterize a successful launch for Orforglipron a year from now.

Answer

Ken Custer, President of Lilly Cardiometabolic Health, explained that key success factors for Orforglipron's launch would include market expansion, particularly among patients awaiting an oral option, and real-world patient satisfaction and efficacy, highlighting the drug's simple profile without food or water restrictions. Mike Czapar, SVP of Investor Relations, facilitated the question.

Evan Seigerman asked Dan Skovronsky to elaborate on his excitement for the presymptomatic Alzheimer's program and how his view has evolved since its initiation.

Answer

Dan Skovronsky, Chief Scientific Officer and President of Lilly Immunology, reiterated his excitement, citing data from TRAILBLAZER 1 and 2 which showed the largest treatment effects in patients earliest in their disease course. He expects similar profound results in TRAILBLAZER-ALZ 3 and TRAILRUNNER-ALZ 3.

Evan Seigerman asked Dan Skovronsky to elaborate on his excitement for the presymptomatic Alzheimer's program, and how this view has evolved since the program's initiation, despite not commenting on interim looks.

Answer

Dan Skovronsky, CSO and President of Lilly Immunology, reiterated his excitement for the presymptomatic Alzheimer's opportunity. He cited data from Trailblazer 1 and 2, which showed the largest treatment effect in patients earliest in their disease course and profound results in preventing progression. He expects similar outcomes in Trailblazer 3 and TRAILRUNNER-ALZ 3, maintaining his enthusiasm and confidence.

Evan Seigerman of BMO Capital Markets followed up on the drug pricing discussion, asking for practical examples of what the pharmaceutical industry can do to help achieve the administration's goal of global price parity.

Answer

David Ricks, Chair and CEO, reiterated that using new products as an 'on-ramp' for price rebalancing is a reasonable proposition, contingent on higher reimbursement in Europe and changes to the U.S. gross-to-net system. He also highlighted that direct-to-consumer channels provide valuable price transparency, which is a positive step supported by the administration.

Evan Seigerman expressed surprise at the update on tirzepatide for heart failure with preserved ejection fraction (HFpEF) and asked for more detail on what additional data the FDA requires that was not provided by the SUMMIT trial.

Answer

Dr. Dan Skovronsky, Chief Scientific Officer, explained that despite the strong and profound benefit shown in the SUMMIT trial, the FDA indicated that multiple trials are needed to support this indication. He noted that while it's possible other trials could provide supporting data, the patient population is already covered under the obesity indication, which unfortunately curtails the incentive to run large, costly outcome trials for a benefit that is already widely understood by physicians.

An associate for Evan Seigerman of BMO Capital Markets asked about lessons learned from peer launches in Alzheimer's and the early experience with the Kisunla launch.

Answer

Executive Anne White explained that the focus is on system readiness for diagnosis and treatment. She noted positive early indicators, including over 80% P&T approvals in key accounts and growing use of diagnostics. Kisunla's profile (monthly infusion) is seen as helpful for managing system capacity constraints.

Evan Seigerman of BMO Capital Markets asked about the financial impact of compounded drugs on demand and sought Lilly's perspective on the FDA's stance regarding the drug shortage list and compounding.

Answer

Patrik Jonsson, President of Lilly Cardiometabolic Health and Lilly USA, stated that the financial impact from compounding is not estimated to be significant, with the main concern being patient safety. CEO David Ricks added that the FDA likely wants to protect its regulatory framework and that Lilly would welcome faster collaboration with the agency to approve legitimate new manufacturing capacity.

Evan Seigerman asked about the specific metrics Pfizer is using to measure the return on its AI investment, and how the company ensures this investment derives a good return rather than just feeding into industry hype.

Answer

CEO Albert Bourla stated that AI is a strategic priority due to significant success, driving productivity gains across all functions. Chief Scientific Officer Chris Boshoff noted that R&D success is measured by productivity (speed and cost reduction). Chief U.S. Commercial Officer Aamir Malik highlighted AI's role in improving field force productivity and increasing Marketing ROI. Chief International Commercial Officer Alexandre de Germay detailed AI's impact on pre-call planning, advanced targeting, and accelerating regulatory review of promotional materials. CFO Dave Denton added that AI leverages vendor platforms and automates routine transactions across hundreds of markets, making operations more efficient.

Evan Segerman from BMO Capital Markets asked about the metrics Pfizer is using to measure the return on investment for its AI initiatives and broadly sought assurance that these investments are deriving good returns rather than just feeding into hype.

Answer

Dr. Albert Bourla, Chairman and CEO, Pfizer, explained that AI is being deployed rapidly where technology is ready, affecting enabling functions, R&D, marketing, and manufacturing, leading to significant productivity gains. Dr. Chris Boshoff, Chief Scientific Officer, Pfizer, specified that R&D success is measured by productivity (speed and cost reduction). Aamir Malik, Chief U.S. Commercial Officer and EVP, Pfizer, cited field force productivity and increased Marketing ROI (MROI) as key metrics. Alexandre de Germay, Chief International Commercial Officer and EVP, Pfizer, highlighted AI's impact on pre-call planning, advanced targeting, and accelerating regulatory approval for promotional materials. Dave Denton, CFO, Pfizer, added that AI leverages vendor platforms and automates routine transactions across markets, increasing efficiency.

Evan Seigerman asked about the near-term factors Pfizer must consider to continue growing its dividend if the MedSera acquisition closes. He also inquired about the priority of share repurchases given the recent business development activity and the timeline for resuming them.

Answer

Dave Denton, CFO, highlighted Pfizer's embedded productivity improvements, which have reduced leverage and provided flexibility for both business development and dividend growth. He stated that Pfizer would continue to prioritize R&D investments in key growth assets and recently acquired/launched products to offset LOEs. He noted that while share repurchases are important, they are not a near-term priority as the company focuses on returning its balance sheet to target levels.

Evan Seigerman asked about the near-term factors Pfizer must consider for growing its dividend and delevering, assuming the Metsera acquisition closes, and when share repurchases might resume given current business development activities.

Answer

Dave Denton, CFO, Pfizer, highlighted ongoing productivity efforts across the platform, which have enabled deleveraging and flexibility to maintain and grow the dividend. He emphasized continued investment in key pipeline assets and recently launched products to offset LOEs. He stated that share repurchases are not a near-term priority as the company focuses on bringing the balance sheet back to target leverage levels. Albert Bourla, Chairman and CEO, Pfizer, also contributed.

Evan Seigerman of BMO Capital Markets asked which Seagen assets, besides Padcev, have the potential to drive a positive IRR on the acquisition, and questioned the potential market share for SV in non-small cell lung cancer.

Answer

CEO Albert Bourla emphasized the value of the Seagen acquisition was in the ADC platform and pipeline, not just in-line products. Chief Scientific Officer Chris Boshoff highlighted upcoming readouts for Padcev in muscle-invasive bladder cancer and the potential of SV, which has shown a 31% response rate in late-line lung cancer and promising combination data.

Evan Seigerman of BMO Capital Markets asked which assets from the Seagen acquisition, aside from Padcev, could drive a positive IRR, and what portion of the non-small cell lung cancer market SV (sivodatotag vedotin) could capture.

Answer

Chairman & CEO Albert Bourla reiterated the goal to grow Seagen revenues to $10 billion by 2030, emphasizing the platform's value. Chief Scientific Officer Chris Boshoff highlighted the pipeline's potential, including Padcev's expansion in bladder cancer, SV's opportunity in NSCLC based on strong response rates, and other promising ADCs like PDL1V.

Evan Seigerman inquired about the key characteristics and desired clinical profile for a future obesity asset following the discontinuation of danuglipron.

Answer

Chief Scientific Officer Chris Boshoff explained that Pfizer sees the future of obesity treatment as fragmented, requiring differentiated oral medicines with an emphasis on tolerability, accessibility, and personalized combinations. Chief Strategy and Innovation Officer Andrew Baum added that the company is seeking both clinical differentiation, such as improved tolerability and muscle preservation, and commercial differentiation through the specific indications pursued.

Evan Seigerman asked how Pfizer plans to work with Robert F. Kennedy Jr. as the potential new Head of HHS, given his publicly known skepticism towards vaccines and the pharmaceutical industry.

Answer

CEO Albert Bourla stated he is 'cautiously optimistic,' noting he has met with Mr. Kennedy and focused discussions on areas of agreement like cancer and chronic diseases. He believes Mr. Kennedy's views will be more tempered in an official role and that the broader scientific community would oppose any radical changes to vaccine policy.

Evan Seigerman asked new Chief Strategy and Innovation Officer Andrew Baum for his initial findings on Pfizer's portfolio and how he plans to shape it for sustainable growth.

Answer

EVP and Chief Strategy and Innovation Officer Andrew Baum praised Pfizer's R&D engine for its strong track record of internal discovery. He stated his primary goal is to ensure this powerful R&D machine is focused on areas that translate into significant revenue, emphasizing that when Pfizer focuses on a goal, its execution is something investors can feel comfortable about.

Evan Seigerman asked for context on the importance of Islatravir's dual regimen compared to the standard-of-care triple regimen like Biktarvy, and the broader unmet need for a dual regimen in HIV treatment.

Answer

Dean Li, President of Research Labs, highlighted Islatravir as a next-generation nucleoside analog with high potency and resistance barrier. He explained the need for different treatment options, including two-drug regimens, which can offer benefits regarding metabolic and long-term issues. He also emphasized the potential for once-weekly two-drug options (Islatravir lenacapavir) and a once-monthly oral PrEP (MK-8527).

Evan Seigerman asked for context on the importance of a dual HIV regimen, like Islatravir in combination with Doravirine, compared to the standard-of-care triple regimen (Biktarvy), and the broader unmet need for such an option.

Answer

Dean Li, President of Research Laboratories, Merck & Co. Inc, highlighted Islatravir as a next-generation nucleoside analog with high potency and resistance. He noted the ongoing need for diverse HIV treatment options, including two-drug regimens without an INSTI backbone, which could address metabolic and long-term issues. He also emphasized the potential for the first once-weekly two-drug regimen (with Gilead and Islatravir/Lenacapavir) and a once-monthly oral PrEP (MK-8527), addressing significant unmet needs for novel dosing frequencies.

Evan Seigerman of BMO Capital Markets asked about Merck's due diligence approach for assets from Chinese versus Western companies, using the Verona Pharma acquisition as a point of comparison.

Answer

Dr. Dean Li, President of Merck Research Labs, stated that Merck maintains a high standard for all assets, regardless of origin. He emphasized that Verona Pharma was followed for years and its first-in-class, U.S.-approved status provided a critical first-mover advantage that other assets in China did not possess.

Evan Seigerman of BMO Capital Markets asked about Merck's business development diligence process, contrasting the acquisition of Western-based Verona Pharma with a competitor's recent collaboration for a Chinese-developed PDE3/4 inhibitor.

Answer

Dr. Dean Li, President of Merck Research Laboratories, stated that Merck has a high standard for all assets and had followed Verona for over five years. He highlighted that Verona's Otovair is the first novel mechanism approved for inhaled COPD treatment in the U.S., giving it a critical first-mover advantage that other assets, including those from China, did not possess.

Evan Segerman asked about Regeneron's confidence in moving its GLP-1 GIP into Phase III clinical trials globally, given the rapidly evolving market, and what differentiates this asset from currently available standard of care and other advanced assets.

Answer

Dr. Leonard Schleifer, Board Co-Chair, Co-Founder, President, and Chief Executive Officer, Regeneron Pharmaceuticals, emphasized the biggest advance is the ability to combine the GLP-1 GIP with Regeneron's PCSK9 inhibitor in the same syringe, offering a highly differentiated solution for obese patients with high cholesterol. Dr. George Yancopoulos, Board Co-Chair, Co-Founder, President, and Chief Scientific Officer, Regeneron Pharmaceuticals, added that the asset has been extensively studied in China, showing tirzepatide-like efficacy and safety. He stressed that the strategy is not to compete solely on weight loss, but to add a completely new benefit of 50%-60% LDL lowering, addressing cardiovascular risk.

Evan Segerman inquired about Regeneron's confidence in advancing its GLP-1 GIP into Phase III clinical trials globally, given the rapidly evolving market, and asked about its differentiation from current standard of care and other advanced assets.

Answer

Dr. Leonard Schleifer, Board Co-Chair, Co-Founder, President, and Chief Executive Officer, Regeneron Pharmaceuticals, emphasized the key differentiation lies in the ability to combine it with their PCSK9 inhibitor in the same syringe for obese patients with high cholesterol. Dr. George Yancopoulos, Board Co-Chair, Co-Founder, President, and Chief Scientific Officer, Regeneron Pharmaceuticals, added that olorelapide is comparable to Tirzepatide in efficacy and safety, with advanced Phase 3 trials in China, but the core strategy is to add a new benefit (LDL lowering) rather than solely competing on weight loss.

Evan Seigerman from BMO Capital Markets asked about internal changes Regeneron has made within its regulatory and manufacturing teams to prevent recent Complete Response Letters (CRLs) and ensure timely product approvals.

Answer

Regeneron President and CEO, Leonard Schleifer, addressed the question directly, stating that the issues were not due to internal regulatory problems, as their team has extensive expertise and strong FDA relationships. He acknowledged that having their own filling capabilities would be ideal, but its online launch was delayed by COVID-related supply chain issues, now expected next year. He also noted the complexity and resource intensity of establishing backup fillers, and that similar manufacturing issues have affected other major companies.

Evan Seigerman asked about internal changes Regeneron has made within its regulatory and manufacturing teams to prevent Complete Response Letters (CRLs) and ensure timely product approvals.

Answer

President and CEO Leonard Schleifer stated that the issues have not been internal regulatory problems, citing a strong regulatory team and relationship with the FDA. He acknowledged manufacturing as an area for improvement, specifically the delay in bringing their own filling plant online due to COVID-related supply chain issues, now expected next year. He also noted the complexity and time required for FDA approval of backup fillers, a challenge faced by many large companies.

Evan Seigerman of BMO Capital Markets asked about the Most Favored Nation (MFN) policy, questioning what mechanisms Regeneron has to influence OUS pricing for products marketed by partners like Bayer.

Answer

President & CEO Dr. Leonard Schleifer acknowledged it's a significant issue, noting that for existing products like EYLEA, Regeneron does not control the OUS pricing set by its partner, Bayer. He suggested that future contracts for new drugs would likely need to address this contingency.

Evan Seigerman of BMO Capital Markets asked about the practical ability of Regeneron to influence drug prices outside the U.S. to comply with a potential MFN policy, especially for products marketed by partners.

Answer

President & CEO Dr. Leonard Schleifer acknowledged this as a key complication, noting that for existing products like EYLEA, they do not control the OUS pricing set by their partner, Bayer. He speculated that future licensing agreements for new drugs would likely need to incorporate contingencies to address this issue.

Evan Seigerman of BMO Capital Markets posed a hypothetical question about redesigning Medicare patient assistance, asking how Regeneron would structure such a program if not for current legislative and charitable constraints.

Answer

President and CEO Dr. Leonard Schleifer advocated for allowing manufacturers to provide direct co-pay assistance to Medicare patients, similar to the commercial market. He argued this could be enabled by presidential action and would ensure patients receive the best treatment chosen by their doctors, rather than being forced onto less optimal therapies due to cost.

Evan Seigerman of BMO Capital Markets asked about the regulatory environment for muscle-preserving obesity drugs and how Regeneron sees the FDA's perspective evolving on endpoints beyond simple weight loss.

Answer

President and CSO Dr. George Yancopoulos explained that the easiest regulatory path would be demonstrating greater total weight loss with a better body composition, as preserving muscle increases metabolic rate. He noted the company is also measuring metabolic and functional endpoints, which could support approval but would likely require longer, more complex studies. He mentioned ongoing discussions with regulatory agencies and highlighted the potential of future unimolecular solutions to streamline the regulatory path.

Evan Seigerman asked about Scholar Rock's sales and market research efforts to identify patients ahead of the apitegromab launch, particularly the work with Centers of Excellence. He questioned if these efforts are leading to a more robust patient identification, potentially resulting in faster market uptake than initially anticipated.

Answer

Chief Operating Officer Keith Woods highlighted that the extended pre-launch time has allowed the team to deepen engagement with SMA treatment teams and patient advocacy groups, beyond just physicians. He noted strong acceptance of apitegromab's dual modality approach (targeting motor neurons and muscle) and its favorable safety profile, suggesting that patients will seek the world's first muscle-targeted therapy for potential muscle gain.

Evan Seigerman asked about Scholar Rock's sales and market research efforts to identify patients ahead of the apitegromab launch, particularly focusing on whether these efforts are leading to a more robust patient count and potentially faster uptake post-approval.

Answer

Keith Woods, Chief Operating Officer, highlighted increased engagement with SMA treatment teams, patient advocacy groups, and families, noting a clear understanding of the unmet medical need for a dual-modality approach targeting muscle. He emphasized that the extended pre-launch time allows for deeper understanding of the patient journey and strengthens the belief in apitegromab's potential for faster uptake due to its unique muscle-targeted mechanism and strong safety profile.

Evan Seigerman of BMO Capital Markets asked for more color on the late-cycle review, specifically regarding discussions on the 10mg vs. 20mg doses, and for guidance on post-launch spending cadence.

Answer

President of R&D Akshay Vaishnaw confirmed the dose analysis was discussed, explaining that since both doses had similar pharmacodynamic effects, the company expects the 10mg dose to be approved. CFO Vikas Sinha projected that 2026 spending would be similar to 2025, with a shift from some clinical expenses to funding SRK-439 and other pipeline programs.

Evan Seigerman from BMO Capital Markets asked Bob Bradway to elaborate on policy changes needed to encourage greater biosimilar uptake, specifically referencing the continued dominance of Humira over Amjevita.

Answer

Robert Bradway, CEO, distinguished between Part B and Part D market dynamics, expressing confidence in Amjevita's long-term success despite current rebate dynamics. He emphasized the importance of safe, reliable supply for biosimilars in the U.S. market.

Evan Seigerman asked what policy changes Amgen believes are necessary to encourage greater biosimilar uptake, specifically addressing why Humira remains the top-selling adalimumab product over Amjevita and how Amgen plans to promote increased use of its biosimilar products.

Answer

Robert Bradway, CEO, differentiated between Part B (physician-administered) and Part D (retail) medicines, noting distinct market dynamics. He expressed confidence in Amjevita's long-term success, citing its strong international performance and the value of a safe, reliable supply in the U.S. market, suggesting that Part D rebate dynamics are evolving over time.

Evan Seigerman asked for details on what is driving the strong volume growth for IMDELTRA and how the launch trajectory might continue through the rest of the year.

Answer

Murdo Gordon, EVP of Global Commercial Operations, attributed the growth to strong clinical conviction from compelling survival data and improved operational execution in both academic and community settings. Robert Bradway, Chairman & CEO, added the launch's success is encouraging for the entire BiTE platform.

Evan Seigerman of BMO Capital Markets inquired about the expected near-term uptake of PAVBLU, the Eylea biosimilar, following the implementation of its permanent J-code, and whether a shift towards biosimilars is occurring due to changes in patient assistance funding.

Answer

Murdo Gordon, EVP of Global Commercial Operations, reported that PAVBLU has been well-received by retina specialists, who appreciate its quality and prefilled syringe. He noted that contracting with large retina groups is in progress. On patient assistance, he stated that Amgen continues to support patients through charitable donations to various agencies.

Evan Seigerman asked about the launch strategy for Amgen's EYLEA biosimilar, specifically how the company plans to stimulate demand among ophthalmologists and whether it can offer rebates or extended invoicing.

Answer

EVP of Global Commercial Operations Murdo Gordon declined to discuss specific contracting details but affirmed that Amgen has a broadly deployed field force, strong institutional relationships, and has seen high receptivity. He emphasized the company's experience and preparedness for biosimilar launches.

Evan Seigerman asked about the competitive landscape for PD-1/VEGF bispecifics, specifically the implications of recent ESMO data from the Harmony 6 trial for squamous non-small cell lung cancer, and how it informs Bristol Myers Squibb's confidence in its partnership with BioNTech and their pomitomig program.

Answer

Chris Boerner, Board Chair and CEO, affirmed the strong and tight relationship with BioNTech. Adam Lenkowsky, Chief Commercialization Officer, stated that pomitomig has the potential to become a new standard of care, with competitor data adding to conviction for their broad development program. He highlighted multiple ongoing trials across solid tumor indications, including NSCLC, SCLC, TNBC, MSS CRC, and gastric cancer, emphasizing a focus on speed to market and the ability to combine pomitomig with novel combinations.

Evan Seigerman inquired about the competitive landscape for PD-1/VEGF bispecifics, specifically referencing the PFS benefit data from the Harmony 6 trial at ESMO in squamous non-small cell lung cancer, and how this data informs Bristol Myers Squibb's BioNTech partnership and Pumitomig program.

Answer

CEO Chris Boerner affirmed the strong BioNTech partnership. Chief Commercialization Officer Adam Lenkowsky stated that the observed data, including competitor results, reinforces conviction in Pumitomig's potential as a new standard of care. He highlighted multiple ongoing trials across solid tumor indications, including first-line non-small cell lung cancer, small cell lung cancer, and triple-negative breast cancer, with a focus on speed to market and novel combinations.

Evan Seigerman from BMO Capital Markets questioned the rationale for partnering with BioNTech on its PD-L1 VEGF bispecific, asking what differentiates the asset and how BMY plans to accelerate its development.

Answer

CEO Chris Boerner emphasized the strategic advantage of being first or second to market, a key learning from Opdivo. EVP & Chief Commercialization Officer Adam Lenkowsky added that BMY can leverage its extensive IO infrastructure to accelerate development. EVP & Chief Medical Officer Samit Hirawat highlighted the asset's potential for enhanced tumor specificity as a key differentiator.

Evan Seigerman asked about the company's stance on potential 'most favored nation' pricing and its impact on IRA negotiations, and also inquired about how the reduced REMS monitoring requirement for Camzyos could accelerate sales.

Answer

CEO Christopher Boerner responded that while ex-U.S. countries should pay more for innovation, the focus in the U.S. should be on fixing system complexities like middlemen and the IRA's 'pill penalty'. Chief Commercialization Officer Adam Lenkowsky added that the Camzyos label update simplifies treatment, opens capacity at centers of excellence, and is expected to drive continued strong growth.

Evan Seigerman of BMO Capital Markets asked for a walkthrough of the business development process that led to the Karuna acquisition and inquired about the drivers behind the strong uptake of Camzyos.

Answer

CEO Christopher Boerner described a disciplined BD process for Karuna, emphasizing senior leadership ownership, compelling science, and financial rigor. CCO Adam Lenkowsky attributed the strong growth of Camzyos to high persistency and an expanding prescriber base, noting that an upcoming PDUFA date to ease monitoring requirements and new data in nonobstructive HCM are expected future growth drivers.

Evan Seigerman inquired about the commercial and Medicaid access ramp for Cobenfi over the next year following its recent FDA approval.

Answer

Chief Commercialization Officer Adam Lenkowsky detailed that Cobenfi is a 2025 launch, with a sales ramp expected in the second half of the year after broad access is secured. He anticipates achieving 80-85% access within approximately one year, noting that the process for Medicaid P&T reviews and protected-class Medicare coverage will be key gating factors.

Evan Seigerman asked about a 10-K disclosure regarding a warning letter from the Make America Healthy Again Commission concerning DTC (Direct-to-Consumer) advertisements for INGREZZA, inquiring about the letter's content and necessary corrections.

Answer

Kyle Gano, Chief Executive Officer, stated that many in the industry received similar letters. He emphasized Neurocrine Biosciences' commitment to responsible advertising as an important part of their business for patient reach and education, assuring that they will continue to operate responsibly.

Evan Seigerman asked about a disclosure in the 10-K regarding a warning letter from the Make America Healthy Again Commission concerning INGREZZA's DTC advertisements, inquiring about its contents and necessary corrections.

Answer

Kyle Gano, Chief Executive Officer, stated that many in the industry received similar letters. He viewed it as an opportunity for responsible advertising to reach and educate patients, affirming Neurocrine Biosciences' commitment to conducting advertising responsibly and continuing business as usual.

Evan Seigerman from BMO Capital Markets asked for the rationale behind advancing the muscarinic agonist dereclidine (NBI-1117568) into Phase 3, given the Phase 2 data did not show a dose-response.

Answer

CEO Kyle Gano explained that the decision was based on the 'totality of the data' from the Phase 2 study. He stated that while there wasn't a classic dose-response, all doses worked, and the dose selected for Phase 3 met its primary endpoint and all key secondary endpoints. He emphasized the overall profile is very attractive from an efficacy, safety, and tolerability standpoint, which they believe will differentiate it from competitors.

Speaking for Evan Seigerman, Malcolm Hoffman asked about the decision to amend the Takeda agreement to gain worldwide rights for Osavampator and whether it was driven by confidence in MDD alone or potential for other indications.

Answer

CEO Kyle Gano explained the decision was a 'win-win' for both companies. Neurocrine is very excited about the Phase 2 data, while Takeda has been making strategic moves away from classical psychiatry. The new arrangement allows Neurocrine to drive development more nimbly globally (ex-Japan), while Takeda retains rights in Japan, where the compound originated, and continues to participate in the economics.

Evan Seigerman from BMO Capital Markets asked for help framing the INGREZZA opportunity in Huntington's disease chorea and questioned the timing and rationale for updating the tardive dyskinesia (TD) prevalence estimate.

Answer

CCO Eric Benevich explained the TD prevalence update to at least 800,000 people reflects continued growth in antipsychotic use and was a routine update after several years. CEO Kyle Gano framed the Huntington's chorea opportunity as roughly 15,000 untreated patients, a much smaller but still important market compared to the 800,000 TD patients.

Evan Seigerman of BMO Capital Markets asked how Gilead's commercialization approach for Yes2Go and Descovy would change if PrEP were removed as a preventative medicine by the HHS Preventative Task Force (USPSTF).

Answer

Chief Commercial Officer Johanna Mercier stated that while Gilead supports the current USPSTF guidelines that enable $0 copays, the PrEP market was growing strongly even before the guidelines were widely enforced. She expressed confidence that, should the guidelines change, Gilead could work directly with payers to maintain broad access for HIV prevention based on strong clinical value and demand.

Evan Seigerman of BMO Capital Markets asked how Gilead's commercialization approach for its PrEP franchise would change if the U.S. Preventive Services Task Force (USPSTF) were to remove PrEP's designation as a preventative medicine.

Answer

Chief Commercial Officer Johanna Mercier stated that while Gilead fully supports the current USPSTF guidance which enables zero-dollar copays, the company could adapt to a change. She reminded listeners that the PrEP market was growing strongly even before the guidelines were widely enforced in the past year, and Descovy had already achieved significant market share. Mercier expressed confidence that Gilead could continue to work directly with payers to ensure broad access to HIV prevention regardless of the USPSTF's formal guidance.

Evan Seigerman asked for more detail on the competitive dynamics in cell therapy, specifically whether share pressure is coming more from other CAR T products or from bispecific antibodies.

Answer

Cindy Perettie, Executive Vice President of Kite, confirmed that the competitive headwinds are coming from both bispecifics and in-class CAR T competition. She noted the specific dynamic varies by product (Yescarta vs. Tecartus) and geography, with new in-class approvals being a factor outside the U.S. and bispecifics impacting certain indications in the U.S. and Europe.

On behalf of Evan Seigerman, Conrad asked about Replimune's plans for manufacturing resiliency, including potential second sites, and the key drivers behind RP1's attractive cost of goods profile.

Answer

CEO Sushil Patel affirmed that the company's U.S. manufacturing facility has built-in redundancy and sufficient capacity to meet long-term global demand for RP1 and future pipeline products like RP2 and RP3. He explained that the strategic decision to invest in their own manufacturing early on is the primary driver of their attractive cost of goods, which enables an off-the-shelf product with ample inventory for a broad and rapid launch.

Evan Seigerman from BMO Capital Markets asked management to characterize their confidence in the safety profile of TSHA-102 and to provide the dosing date for the most recent patient.

Answer

President and Head of R&D Sukumar Nagendran expressed high confidence, stating that as of the April data cutoff, there were no treatment-emergent serious adverse events or dose-limiting toxicities. He noted the benefits far outweigh the risks. CEO Sean Nolan added that having dosed more patients at the high dose than the low dose is also comforting. The specific date of the last dose was not provided.

Evan Seigerman asked whether the mRNA therapeutic vaccine franchise remains a core part of BioNTech's strategy amid varying public views on the technology, or if the focus is shifting more towards bispecifics.

Answer

CEO Ugur Sahin emphatically confirmed that mRNA therapeutics are a core focus. He described a dual strategy pursuing two pan-tumor opportunities: BNT327 as a new IO backbone and mRNA immunotherapies for high-risk relapse patients. He stressed the potential of combining these platforms and stated it is the right time to increase investment in mRNA technology.

On behalf of Evan Seigerman, an analyst asked about the competitive positioning of Arvinas's LRRK2 degrader against more advanced programs, such as the one from Biogen.

Answer

CMO Noah Berkowitz positioned Arvinas's LRRK2 degrader, ARV-102, as highly competitive and differentiated. He argued that unlike inhibitors which may lack sufficient brain penetration, ARV-102 achieves significant brain penetration and degrades the entire LRRK2 protein, not just its kinase activity, which he believes is critical for efficacy and provides a key advantage.

Connor McKay, on behalf of Evan Seigerman from BMO Capital Markets, asked for the key drivers behind the strong performance of VYALEV and Elahere, which both came in ahead of analyst expectations.

Answer

CCO Jeffrey Stewart explained that VYALEV is seeing strong uptake in Japan and Europe, with exceptional early feedback in the U.S. commercial market ahead of full Medicare reimbursement. For Elahere, he noted the U.S. business continues to perform well, and the company is now seeing the beginning of international launch ramps. CEO Robert Michael added that the success of Elahere, from the ImmunoGen acquisition, highlights the strength of AbbVie's emerging oncology pipeline, including its internally discovered ADCs.