David Risinger

David Risinger inquired about the similar headline CSAMI numbers between the two brepocitinib arms, requesting more color on baseline characteristics, and asked about the potential for the FDA to grant priority review for brepocitinib in dermatomyositis.

Answer

Matt Gline, CEO of Roivant, and Benjamin Zimmer, CEO of Priovant Therapeutics, explained that baseline imbalances, including disease duration and plaque-predominant morphology, likely contributed to similar headline numbers, but more stringent endpoints showed separation. Gline noted that dermatomyositis is a severe disease with limited options, making priority review a possibility, though it's ultimately the FDA's decision.

David Risinger inquired about the similar CSAMI numbers between the two brepocitinib arms despite different baseline characteristics and the potential for the FDA to grant priority review for brepocitinib in dermatomyositis.

Answer

Matt Gline, CEO of Roivant, explained that baseline imbalances, such as disease duration and plaque-predominant morphology, likely contributed to the similar headline numbers, with the 45mg arm showing better results on more stringent endpoints. He noted that dermatomyositis is a severe disease with limited options, suggesting a chance for priority review, though it's ultimately the FDA's decision.

David Risinger inquired about the next steps for Pfizer litigation, specifically in international markets and the U.S.

Answer

CEO Matt Gline stated that it's difficult to comment on ongoing litigation but advised watching for the scheduling process for the Pfizer case in the U.S., including a potential trial date in the near future. He had no specific timing updates for international cases.

David Risinger asked for an update on the Pfizer litigation, specifically what to watch next in both international markets and the U.S.

Answer

CEO Matthew Gline stated that it's difficult to comment on ongoing litigation but advised watching for the scheduling process and a trial date for the Pfizer case in the U.S. in the near future. He noted no specific timing updates for international cases.

David Risinger asked for an overview of the development roadmap for brepocitinib in non-infectious uveitis (NIU), including the timeline for pivotal data and a potential regulatory filing.

Answer

CEO Matt Gline confirmed that enrollment for the NIU pivotal trial is progressing well and reiterated guidance for a top-line data readout in 2027. He anticipates filing a supplemental New Drug Application (sNDA) shortly after receiving the data. Gline highlighted the strategic timing, which would allow Roivant to add the NIU indication soon after the potential launch in dermatomyositis, targeting a concentrated and tractable physician base.

David Risinger of Leerink Partners asked for an update on the expected timing of the Markman decision in the Pfizer LNP litigation and requested a framework for interpreting the upcoming 2026 data readouts for IMVT-1402 in difficult-to-treat RA and cutaneous lupus (CLE).

Answer

CEO & Director Matt Gline stated there is no specific timeline for the Pfizer Markman ruling but hopes for a decision later in the year, cautioning that the timing holds no specific signal. For the 2026 readouts, he explained the CLE study is a placebo-controlled trial to inform a go/no-go decision for a pivotal program, while the open-label RA data will provide a clear signal on whether to progress, acknowledging the challenges of the RA market.

David Risinger inquired about Roivant's efficacy benchmarks for the upcoming batoclimab data and the company's expectations for the 6-month remission results in Graves' disease.

Answer

CEO Matthew Gline stated that the company's pre-data positioning was solidified by its recent stock purchase. He emphasized that the upcoming data is a referendum on an MG study's ability to show differentiation and that a clear dose response would be a key indicator of success. For the Graves' data, Gline expressed hope for a reasonable rate of patients remaining in remission off-therapy, which would be significant for patients and payers.

David Risinger inquired about the similar headline CSAMI numbers between Brepo dose arms despite baseline differences, and the potential for the FDA to grant priority review for the dermatomyositis NDA.

Answer

CEO Matt Gline explained that baseline differences, such as disease duration and plaque-predominant morphology, likely contributed to similar headline numbers, with more stringent endpoints showing better separation. He noted that while DM is a severe disease with limited options, priority review is ultimately up to the FDA.

David Risinger, Senior Managing Director at Leerink Partners, asked for more details on why the headline CSAMI numbers were similar between brepocitinib's two dose arms despite reported baseline differences, and whether the FDA might grant priority review for the dermatomyositis NDA.

Answer

Matt Gline, CEO of Roivant Sciences, explained that baseline imbalances, such as disease duration and plaque-predominant morphology in the 45mg arm, likely contributed to the similar headline CSAMI numbers, noting better separation on more stringent endpoints. He also stated that while DM is a severe disease with limited options, priority review for the NDA is ultimately up to the FDA.

David Risinger asked about the hypotension risk associated with Admilparant and how Bristol Myers Squibb contextualizes it. He also sought clarity on the generic competition assumptions within the guidance, specifically for Eliquis ex-US entry in 2026 and 2027, and the anticipated number of players and timing for Orencia biosimilars.

Answer

Cristian Massacesi (Executive Vice President, Chief Medical Officer, and Head of Global Drug Development, Bristol Myers Squibb) stated that Admilparant's hypotension and syncopal episodes, a Phase II risk, are well-managed in Phase III, even at higher doses, with no concerns raised by the DMC. Adam Lenkowsky (Executive Vice President and Chief Commercial Officer, Bristol Myers Squibb) added that physicians find it a manageable side effect, positioning Admilparant as a potential best-in-class product. David Elkins (EVP and CFO, Bristol Myers Squibb) attributed the Eliquis $1.5-$2 billion stepdown in 2027 to broad-based assumptions about generic entry in ex-US markets, particularly larger EU countries in late 2026. Adam Lenkowsky noted Dr. Reddy's Laboratories' potential biosimilar for Orencia, acknowledging manufacturing challenges but expecting continued cash flow.

David Risinger asked about the hypotension risk associated with Admilparant and how Bristol Myers Squibb contextualizes it. He also sought clarification on generic competition assumptions in the guidance, specifically for Eliquis ex-U.S. entry in 2026/2027 and the number/timing of Orencia biosimilar players.

Answer

Cristian Massacesi, Executive Vice President, Chief Medical Officer, and Head of Development, explained that while hypotension was a tolerability risk in Phase II, it is well-managed in Phase III, even at higher doses (120mg), with the DMC not raising concerns. Adam Lenkowsky, Executive Vice President and Chief Commercial Officer, added that physicians find it manageable, and Admilparant offers a best-in-class profile. David Elkins, EVP and CFO, stated that the $1.5-$2 billion Eliquis step-down in 2027 assumes generic entries spread across ex-U.S. markets, particularly in the EU late 2026. He noted Dr. Reddy's Laboratories has indicated an opportunity to file for an Orencia biosimilar, but manufacturing challenges are recognized.

David Risinger asked about milvexian's profile, specifically its potency and dosing (25mg BID) relative to Bayer's asundexian (50mg QD) in secondary stroke prevention, and the implications of asundexian's upcoming Phase 3 readout for milvexian's 2H 2026 readout. He also inquired if IRA prices for the first 10 price-controlled drugs, including Eliquis, are currently being renegotiated.

Answer

Cristian Massacesi, Chief Medical Officer and Head of Global Drug Development, stated confidence in milvexian's dose characterization and BID administration for better exposure coverage. He noted that a positive competitive SSP trial would validate the Factor 11A mechanism and expressed confidence in milvexian's Phase 3 program to provide a superior profile, highlighting its potential as the only Factor 11a in NAF and ACS. Adam Lenkowsky, Chief Commercialization Officer, added that the AFib readout for milvexian has been accelerated, with all three studies expected in 2026. He confirmed there are no plans to revisit Eliquis' IRA negotiation, with the price effective January 1.

David Risinger asked about Milvexian's profile, specifically its 25 mg BID dosing in secondary stroke prevention compared to Bayer's Asundexian (50 mg QD), and the implications of Asundexian's upcoming secondary stroke phase III trial readout for Milvexian's H2 2026 readout. He also asked if IRA prices for the first 10 price-controlled drugs in 2026, including Eliquis, are currently being renegotiated.

Answer

CMO Christian Massacesi explained that Milvexian's BID administration ensures better exposure coverage, a key differentiation. He stated that a positive competitive SSP trial would validate the Factor 11A mechanism and expressed confidence in Milvexian's phase III program to maximize efficacy, potentially offering a superior profile, and noted its unique position in NAF and ACS. Chief Commercialization Officer Adam Lenkowsky confirmed the acceleration of Milvexian's atrial fibrillation readout to 2026 and stated there was no plan to revisit Eliquis negotiations, with the price effective January 1.

David Risinger from Leerink Partners highlighted investor skepticism about MILVEXIAN's sales potential and asked what the market may be underappreciating about its likelihood of success across its three major indications.

Answer

EVP & Chief Medical Officer Samit Hirawat pointed to the program's differentiated dosing strategy as a key underappreciated factor that could improve the safety profile. EVP & Chief Commercialization Officer Adam Lenkowsky added that the drug has a significant opportunity to address the large number of patients who are currently untreated or undertreated due to the bleeding risks of existing therapies.

David Risinger asked how Bristol's leadership is engaging differently with Washington to defend the biopharma industry against various threats. He also requested details on the disappointing Cobenfy adjunctive trial results, specifically within the risperidone subgroup.

Answer

CEO Christopher Boerner outlined a consistent engagement strategy focused on fixing the IRA, addressing middlemen, and advocating for higher ex-U.S. pricing, noting no significant business impact to date. CMO Samit Hirawat confirmed the company is actively evaluating the risperidone subgroup data from the ARISE trial, including potential drug-drug interactions, before defining next steps.

David Risinger of Leerink Partners asked about the growth setup for 2026 in the context of 2025's loss of exclusivity performance and also inquired about the future growth prospects for Yervoy.

Answer

CFO David Elkins acknowledged the 2025 LOE headwinds but emphasized that the focus is on the growth portfolio, which now constitutes over 50% of the business and is set for further expansion. CCO Adam Lenkowsky added that Yervoy is expected to see continued growth in 2025, driven by solid demand in core indications and upcoming launches in new cancer types.

David Risinger asked for more context on Bristol Myers Squibb's confidence in achieving sustainable long-term growth, especially considering revenue pressures expected in 2026.

Answer

CEO Christopher Boerner detailed three core reasons for his confidence: 1) a young, growing portfolio of assets like Cobenfi, Breyanzi, and Reblozyl; 2) a promising late-stage pipeline with major assets like milvexian and LPA1; and 3) a disciplined financial approach that provides strategic flexibility for both internal R&D and external business development.

David Risinger asked about AbbVie's psychedelic in development, Bretisilocin, and its potential to improve upon the profile of J&J's Spravato.

Answer

Roopal Thakkar, Executive Vice President, Research and Development, and Chief Scientific Officer, explained that Bretisilocin works through the 5-HT2A serotonergic pathway, offering a short-acting hallucination period followed by rapid and durable efficacy, leading to high efficacy and remission-like states in preliminary studies. He noted that the observed data was against an active control, not placebo, and two more readouts are expected before Phase 3, with the potential for high differentiation.

David Risinger asked for more details on AbbVie's psychedelic in development, specifically its profile and potential improvements over J&J's Spravato.

Answer

Roopal Thakkar, EVP, R&D, and Chief Scientific Officer, explained that the psychedelic, Bretisilocin, works via the 5-HT2A serotonergic pathway, offers a short-acting hallucinatory period, and has shown immediate and durable efficacy, leading to remission in a majority of patients. He noted upcoming readouts against a lower dose control arm before Phase III.

Dave Risinger asked about the outlook for accelerating growth as Humira's absolute dollar declines diminish in coming years and requested an overview of the top pipeline candidate readouts expected over the next six months, including Amylin.

Answer

EVP and CFO Scott Reents affirmed confidence in achieving high single-digit growth through the decade as Humira's absolute dollar decline lessens, expecting earnings growth to outpace revenue. EVP, Research and Development, and CSO Roopal Thakkar outlined upcoming readouts in immunology (SKYRIZI combinations, lutikizumab), oncology (TMAB-A, Tantamig, 151, bispecific ADC), neuroscience (VRAYLAR follow-on, imuracladine), and obesity (Amylin Phase 1 and 1B data).

Dave Risinger asked about the outlook for accelerating growth as HUMIRA's absolute dollar declines diminish and requested an update on the top pipeline candidate readouts expected over the next six months, including amylin.

Answer

Scott Reents, Executive Vice President, Chief Financial Officer, explained that HUMIRA's absolute dollar decline will diminish, supporting the long-term guidance of high single-digit growth through the decade, with operating margin expansion driving faster earnings growth. Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer, outlined key pipeline readouts for 2026, including IBD combination data, oncology data, neuroscience data, and obesity data (amylin asset 295).

David Risinger from Leerink Partners inquired about AbbVie's strategy for leveraging its global aesthetics commercial footprint to sell future obesity drugs and its plans for expanding its obesity R&D portfolio.

Answer

EVP & CCO Jeffrey Stewart highlighted the synergy, noting the cash-pay weight loss market is a major driver for aesthetics clinics. EVP & CSO Roopal Thakkar added that AbbVie is open to further BD in obesity, seeking assets that improve tolerability and address muscle loss, potentially for combination with its current amylin asset.

David Risinger of Leerink Partners asked how AbbVie's leadership is engaging differently with Washington amid industry risks and what potential 'trade policy shifts' beyond tariffs the company is considering.

Answer

CEO Robert Michael explained that AbbVie's large government affairs team actively engages with lawmakers on priorities like tax reform, IRA, and 340B, noting recent positive developments in 340B policy. CSO Roopal Thakkar added that FDA interactions remain active with no delays experienced. CFO Scott Reents clarified that his earlier comment on 'trade policy shifts' was specifically referring to potential pharmaceutical sector tariffs and not other contemplated issues.

David Risinger asked for the long-term commercial vision for the ADC candidate ABBV-400 (Tmab-A) and for an update on AbbVie's M&A agenda and strategy following the emraclidine setback.

Answer

EVP & CCO Jeffrey Stewart described ABBV-400 as an underappreciated asset with significant potential, starting in colorectal cancer and expanding into lung cancer, with combination therapies expected to drive major inflection. EVP & CSO Roopal Thakkar highlighted the differentiated safety profile of their ADC platform. CEO Robert Michael outlined the M&A strategy, focusing on early-stage deals to add pipeline depth for the next decade across immunology, oncology, and neuroscience, while noting the financial capacity for larger deals if a differentiated opportunity arises.

Dave Risinger requested more details on MET-233i (now 3945), specifically regarding the bias of amylin relative to calcitonin, its implications for efficacy and tolerability, and the data expected to be presented at ADA.

Answer

Chief Scientific Officer Chris Boshoff described 3945 as an ultra long-acting amylin with previously shown monotherapy efficacy of 8.4% placebo-adjusted weight loss at day 36 and placebo-like tolerability. He noted it's a dual molecule, not biased, and that early combination data with 3944 showed 5% weight loss at day eight. Updated data for this combination will be shared later this year, including at ADA, with the goal of achieving best-in-class efficacy with monthly dosing.

Dave Risinger from Leerink Partners asked for more details on MET233I (now 3945), specifically its amylin bias relative to calcitonin, implications for efficacy and tolerability, and expected data at ADA.

Answer

Dr. Chris Boshoff, Chief Scientific Officer, Pfizer, described 3945 as an ultra-long-acting amylin with previously shown monotherapy efficacy of 8.4% placebo-adjusted weight loss at day 36 and placebo-like tolerability. He clarified it's a dual molecule, not biased to one receptor. He reiterated that early combination data showed 5% weight loss at day 8, with updated data expected later this year, emphasizing its potential for best-in-class efficacy with monthly dosing.

David Risinger inquired about the legal process surrounding the MedSera acquisition, specifically asking Pfizer to comment on its arguments that Novo Nordisk's offer would be anti-competitive and the timeline for courts to hear Pfizer's case.

Answer

Albert Bourla, Chairman and CEO, stated that it was difficult to comment on pending legal issues but reiterated that Novo Nordisk's deal could not be superior, describing it as an 'illegal attempt by a foreign company to do an end run around antitrust laws' to 'cut and kill an emerging competitor.' He confirmed Pfizer is pursuing all legal resources.

Dave Risinger inquired about the legal process ahead for Metsera, specifically Pfizer's antitrust arguments against Novo Nordisk's competing acquisition offer.

Answer

Albert Bourla, Chairman and CEO, Pfizer, stated that while he could not comment extensively on pending legal issues, Pfizer views Novo Nordisk's offer as an illegal attempt to circumvent antitrust laws and eliminate an emerging competitor, given Novo's dominant market position. He reiterated Pfizer's commitment to pursuing all legal resources.

David Risinger of Leerink Partners asked if Pfizer has been educating the U.S. administration on the significant government support provided to biotech companies in China, given the competitive pressures on the U.S. biopharmaceutical industry.

Answer

CEO Albert Bourla confirmed he is very vocal on this topic at all levels of government. He highlighted that China has surpassed the U.S. in the number of clinical studies and is a leader in scientific publications and patent filings. He emphasized the need for the U.S. to support its own biotech industry to remain competitive rather than trying to slow down China.

David Risinger of Leerink Partners asked if Pfizer has been helping the U.S. administration understand the significant government support provided to biotech companies in China, given the competitive pressures on the U.S. biotech industry.

Answer

Chairman & CEO Albert Bourla affirmed that he is very vocal on this topic with all levels of government. He highlighted that China has surpassed the U.S. in areas like clinical study volume and patent filings, emphasizing that the U.S. must focus on supporting its own biotech industry to innovate and be better than the competition.

David Risinger asked for commentary on the U.S. government's perceived negative stance on biotechnology and requested an update on the progress of the 232 investigation.

Answer

CEO Albert Bourla acknowledged concerns over anti-science rhetoric but noted it doesn't represent the entire administration. He uses the competitive threat from China's biotech sector as a key engagement point. He described the 232 investigation as a time-limited process led by the Secretary of Commerce to assess supply chain security, for which companies are currently submitting information.

David Risinger asked about the ability of a potential HHS Secretary, Robert F. Kennedy Jr., to remove the existing U.S. vaccine liability protections for manufacturers.

Answer

CEO Albert Bourla opined that such liability protections are established by Congress and cannot be changed by one individual. He reiterated his 'cautiously optimistic' stance, believing that any attempt to weaken vaccine policy would face broad opposition from the medical community, payers, and the administration itself.

David Risinger asked if management sees opportunities for further SG&A and R&D cost reductions and whether the >30-valent pneumococcal vaccine candidate will be adjuvanted.

Answer

CEO Albert Bourla affirmed that Pfizer will remain cost-conscious and sees ongoing opportunities to reduce investments with lower ROI. Chief Scientific Officer Mikael Dolsten explained that the next-generation vaccine's advancements stem from a 'toolbox' of new technologies, and while they have adjuvants available, it is too early to determine if one will be necessary for the final candidate.

David Risinger asked for more details on the 'souped-up' version of Dupixent currently in development, including its anticipated development path.

Answer

Dr. George Yancopoulos, Board Co-Chair, Co-Founder, President, and Chief Scientific Officer, Regeneron Pharmaceuticals, described the new molecule as potentially longer-acting with other advantages, generated using Regeneron's advanced antibody technologies. He confirmed it would be moved forward in the clinic. Dr. Leonard Schleifer, Board Co-Chair, Co-Founder, President, and Chief Executive Officer, Regeneron Pharmaceuticals, added that while not formally in the alliance, it is covered by the Sanofi collaboration if it proceeds to full development.

David Risinger asked for more details on the 'souped-up version of DUPIXENT' currently in development, including its anticipated development path.

Answer

Dr. George Yancopoulos, Board Co-Chair, Co-Founder, President, and Chief Scientific Officer, Regeneron Pharmaceuticals, described it as a potentially longer-acting antibody with other advantages, which will be advanced into the clinic. Dr. Leonard Schleifer, Board Co-Chair, Co-Founder, President, and Chief Executive Officer, Regeneron Pharmaceuticals, clarified that this asset is covered by the Sanofi alliance if it proceeds to full development.

David Risinger of Leerink Partners highlighted the disconnect between management's optimism for its pipeline and Wall Street's valuation, asking what future events will better demonstrate its commercial value.

Answer

President & CEO Dr. Leonard Schleifer pointed to the R&D team's track record with EYLEA and Dupixent and highlighted the exciting early data and large market opportunity for linvoseltamab in myeloma. President & CSO Dr. George Yancopoulos added that pipeline valuation is likely being capped by concerns over existing products, and the pipeline's potential would be viewed differently in isolation.

David Risinger of Leerink Partners highlighted the disconnect between management's and Wall Street's view of the pipeline's value and asked about the future event path to better illuminate its commercial potential.

Answer

President & CEO Dr. Leonard Schleifer pointed to the company's strong R&D track record (EYLEA, Dupixent) and highlighted the exciting data for linvoseltamab in myeloma, a potential $30B+ market. President & CSO Dr. George Yancopoulos added that pipeline valuation is likely being capped by concerns over existing products.

David Risinger of Leerink Partners asked a high-level question about major U.S. government risks to the biopharma industry, including FDA disruption and drug pricing, and how Regeneron's leadership is engaging differently with Washington.

Answer

President and CEO Dr. Leonard Schleifer acknowledged the disruptive environment and the risks of deviating from science-based policy. He stated the company actively engages to influence policy towards public health, including offering scientific guidance to political figures. He stressed the importance of maintaining scientific principles and experienced personnel at regulatory agencies.

David Risinger of Leerink Partners asked about the obesity program, questioning the need to combine myostatin and activin blockers and if myostatin could be a standalone therapy.

Answer

President and CSO, Dr. George Yancopoulos, confirmed this is their strategy. While the combination may offer more muscle growth, the activin A blockade carries more safety questions. The program is designed to test the combination but allows for a fallback to the myostatin-only approach, which appears safer, providing flexibility to optimize the benefit-risk profile.

David Risinger of Leerink Partners asked about Regeneron's efforts to develop a next-generation Dupixent, specifically inquiring if it would feature less frequent administration.

Answer

President and CSO Dr. George Yancopoulos confirmed that the company is constantly working on improving existing approaches, like it did with EYLEA HD, as well as developing entirely new next-generation products. He affirmed that this dual strategy of improving current therapies and creating novel ones is central to Regeneron's R&D philosophy.

David Reed Risinger asked about the expected timeline for disclosing full results from the Amlitelimab studies and inquired about the offsets to business EPS growth in 2026 and 2027, particularly concerning the decrease in R&D reimbursement from Regeneron and the impact of Amvutra royalties.

Answer

Houman Ashrafian, EVP and Head of Research and Development, stated that COAC1 data for Amlitelimab AD is expected by the end of March, with COAC2 and SURE potentially included. François-Xavier Roger, CFO, explained that a EUR 400 million decrease in Regeneron R&D reimbursement in 2026 would be more than offset by an increase in Amvutra royalties to approximately EUR 1 billion, resulting in a net positive impact of EUR 100 million to BOI. For 2027, the net negative impact is projected to be EUR 400 million, better than previous estimates.

David Reed Risinger asked about the expected timeline for disclosing full results from Amlitelimab studies and inquired about the offsets to the loss of R&D reimbursement from Regeneron that would enable business EPS to grow faster than sales in 2026 and 2027.

Answer

Paul Hudson, CEO, and Houman Ashrafian, EVP and Head of Research and Development, stated that COAC1 data for Amlitelimab AD is expected to be presented by the end of March, with COAC2 and SURE potentially included. François-Xavier Roger, CFO, explained that a EUR 400 million decrease in Regeneron R&D reimbursement in 2026 would be more than offset by an increase in Amvutra royalties to approximately EUR 1 billion, resulting in a net positive impact of EUR 100 million on BOI. For 2027, the net negative impact on BOI from these two items is projected to be a more favorable -EUR 400 million than previously estimated.

David Risinger asked for more color on inhibrics' AATD data, specifically characterizing normal range and trough levels. He also inquired about the expected net change in U.S. Dupixent pricing for 2026 compared to 2025, given that contracting is largely complete.

Answer

Head of R&D Houman Ashrafian stated that for AATD, Sanofi's Q3 and Q4 molecules provide commendable alpha-1 antitrypsin nomogram levels for both trough and mean dose, superior to standard of care which often doesn't reach normal range. Head of General Medicines Brian Foard declined to give specific net price guidance for Dupixent year-over-year but noted that net price development is captured in long-term guidance, reflecting discipline over eight years.

David Risinger asked for a characterization of the normal range and trough levels for efdoralprin alfa (inhibrics) in AATD, and about the net price prospects for U.S. Dupixent in 2026 versus 2025, given that contracting is largely complete.

Answer

Houman Ashrafian (Head of R&D) stated that efdoralprin alfa's Q3 and Q4 W dosing provides 'very commendable' alpha-1 antitrypsin nomogram levels for both trough and mean dose, unlike standard of care which often doesn't reach the normal range. Brian Foard (Head of General Medicines) indicated that Sanofi does not typically provide year-over-year net price guidance, but Dupixent's long-term guidance already captures expected net price development.

David Risinger from Leerink Partners asked for expectations on tolobrutinib in PPMS, specifically regarding efficacy and the anticipated liver toxicity profile.

Answer

EVP & Head of R&D Houman Ashrafian explained that a significant biological overlap between SPMS and PPMS suggests a potential for efficacy read-through. He added that the liver toxicity profile in the PPMS trial is expected to be commensurate with what was observed in the SPMS studies.

David Risinger from Leerink Partners asked about the amount of Nuvaxovid sales included in the 2025 guidance and whether Phase II trial results will be disclosed via press releases.

Answer

Executive Thomas Triomphe explained that the Novavax collaboration is primarily aimed at a future flu/COVID combo vaccine and that 2025 Nuvaxovid sales, which are included in guidance, will be about learning the U.S. market. Executive Houman Ashrafian stated that while the company is conscious of materiality requirements, it will not commit to top-line press releases for all Phase II data, respecting embargoes for major medical meetings.

David Risinger asked for a characterization of itepekimab's sales potential in COPD relative to Dupixent in the same indication. He also inquired about China's interest in Beyfortus and its potential launch path there.

Answer

Brian Foard, EVP and Head of Global Hub, Specialty Care GBU, contextualized the combined peak sales potential for both Dupixent and itepekimab in COPD at roughly EUR 5 billion. Thomas Triomphe, EVP of Vaccines, confirmed China's interest in Beyfortus but clarified it would be a private, out-of-pocket market requiring a progressive ramp-up to build disease awareness from a near-zero base.

David Risinger requested Amgen to identify the top two or three pipeline catalysts expected to be most impactful for the company within the next six to twelve months.

Answer

James Bradner, EVP of Research and Development, highlighted the upcoming VESALIUS-CV data presentation within the next week as a key catalyst. He also emphasized the exciting further development of Imdelltra (tarlatamab), noting its dramatic activity in challenging cases and the potential for meaningful activity in frontline use and combination therapies, with forthcoming phase 3 data eagerly anticipated.

David Risinger from Leerink Partners asked Amgen to identify the top two or three pipeline catalysts expected to be most impactful in the next six to twelve months.

Answer

James Bradner, EVP of Research and Development, highlighted the upcoming Vesalius CV data presentation, and the further development of Imdelltra (tarlatamab), particularly its dramatic activity in small cell lung cancer and potential in combination and frontline therapies. Robert Bradway, CEO, reinforced excitement for Imdelltra, citing profound patient responses.

David Risinger asked about Amgen's strategy for its biosimilar versions of Opdivo, Keytruda, and Ocrevus, specifically how intravenous (IV) biosimilars will compete against subcutaneous (subcu) innovator versions.

Answer

Murdo Gordon, EVP of Global Commercial Operations, stated Amgen is watching subcu uptake closely, noting dosing alignment with chemo is key. James Bradner, EVP of R&D, added that biosimilars will improve access in this established treatment space.

David Risinger questioned the rationale for announcing a new Phase III trial for olpasiran in high-risk primary prevention patients, given its initiation is not planned until late 2025 or early 2026.

Answer

CEO Robert Bradway noted the plan had been mentioned previously. James Bradner, EVP of R&D, added that the announcement underscores Amgen's total commitment to addressing the genetically defined risk of elevated Lp(a) and their firm intention to initiate this important study.

David Risinger asked about Johnson & Johnson's strategy for positioning icotrokinra relative to TREMFYA, given their similar indications, particularly in the context of psoriasis treatment.

Answer

EVP, Worldwide Chairman, Innovative Medicine, Jennifer Taubert expressed excitement for icotrokinra as a potential $5 billion+ brand, aiming to set a new standard of care in plaque psoriasis with an unprecedented combination of complete skin clearance, favorable safety, and oral pill simplicity. She noted that icotrokinra is being studied head-to-head against STELARA and a leading TYK2 inhibitor, and that distinct positioning for both icotrokinra and TREMFYA will allow for continued significant growth due to high unmet market need. EVP, Innovative Medicine Research and Development, John Reed mentioned upcoming publications in the New England Journal of Medicine and The Lancet detailing icotrokinra's data.

David Risinger of Leerink Partners asked if YUPELRI's operating leverage would continue and questioned how the longer endpoint duration in the Ampreloxetine trial might impact results.

Answer

CFO Aziz Sawaf clarified that while YUPELRI's profit margin will continue to expand with sales growth, the significant gap between collaboration revenue growth and net sales growth should not be expected to persist. Head of Development Aine Miller explained the 8-week endpoint is designed to demonstrate durability, a key differentiator. CEO Rick Winningham added that Ampreloxetine's mechanism as a reuptake inhibitor, not an agonist, makes tachyphylaxis less likely.

David Risinger of Leerink Partners asked about potential channel stocking for YUPELRI in Q4, the percentage of sales from non-hospital settings, and the reason for a perceived decline in non-hospital sales.

Answer

Executive Rick Winningham confirmed that year-end inventory levels were normal with no unusual stocking. CBO Rhonda Farnum clarified that hospital volume is only about 10% of the total, with 90% in the community setting. She corrected the premise of a decline, highlighting that overall brand demand grew 11% for the full year, and explained the strategy is to use hospital exposure to drive long-term outpatient scripts.

David Risinger of Leerink Partners asked for an update on U.S. employer coverage for anti-obesity medicines, questioning if net covered lives have been flat and seeking an outlook for coverage changes into the next year.

Answer

Ilya Yuffa, President of Lilly USA, clarified that employer opt-in coverage has been steady at around 50-55%. He expressed optimism that new, more flexible benefit designs being introduced by payers could help grow employer adoption over time as more clinical evidence becomes available.

David Risinger asked about Lilly's discussions with the Trump administration regarding tariffs, focusing on the fact that Lilly's drug IP and API originate from non-hostile countries and the administration's interest in repatriating profits and tax revenue to the U.S.

Answer

CEO David Ricks addressed the complexity, noting Lilly supports repatriating supply chains and has been investing heavily in U.S. manufacturing for years to build resilience. He argued that tariffs are the wrong mechanism and that tax reform is the key to solving the issue long-term. He explained that Lilly's sourcing from countries like Ireland was a result of past tax differentials and that the company is already rebalancing its footprint, making tariffs a potentially transient issue for Lilly.

David Risinger of Leerink Partners asked for color on the cancellation of the long-acting relaxin candidate trials and the company's view on the mechanism's future.

Answer

Executive Daniel Skovronsky stated that the Phase II trial results were disappointing and did not support continuing with the specific molecule. He suggested the issue was with the molecule itself rather than a failure of the underlying biological mechanism.

David Risinger of Leerink Partners asked for more details on the discontinuation of the immunology asset parasolumab, specifically regarding any safety issues and the company's view on developing another PD-1 agonist.

Answer

Dr. Dan Skovronsky, Chief Scientific Officer, stated that the benefit-risk profile observed in the Phase IIa study of parasolumab was not replicated in the larger Phase IIb trial, leading to its discontinuation. He confirmed Lilly is not currently pursuing a follow-on PD-1 agonist and plans to present the full data at a future medical meeting.

David Risinger from Leerink Partners asked for the specific number of commercial lives with unrestricted access to Gernavix and for more details on the expected clinical profile of the next-generation CF candidate, VX-828.

Answer

EVP and CCO Duncan McKechnie reported that of the 150 million covered lives for Gernavix, 84 million have unrestricted access. President and CEO Dr. Reshma Kewalramani stated she expects VX-828 to bring most patients to carrier levels of sweat chloride with a good safety and DDI profile.

David Risinger sought clarification on JOURNAVX payer coverage, asking if the 22 million lives from the new PBM agreement were part of the total 94 million covered lives and whether they were restricted. He also asked a higher-level question about how Vertex engages with Washington leadership on the importance of biotechnology innovation.

Answer

CCO Duncan McKechnie confirmed the 22 million lives are included within the 94 million total and are generally considered unrestricted, meaning no prior authorizations or step edits. CEO Reshma Kewalramani responded that Vertex is actively engaged with D.C. and state governments on all its programs, finding the meetings constructive and describing interactions with regulators and payers as "business as usual."

David Risinger asked for more detail on plans to secure broad, unfettered formulary access for JOURNAVX, emphasizing the need to avoid physician hassles. He also questioned Vertex's strategy to prevent other countries from violating its intellectual property.

Answer

COO Stuart Arbuckle affirmed the goal is broad access with minimal utilization management, a key topic in payer discussions supported by policy like the NOPAIN Act. CFO Charlie Wagner identified the IP-violating country as Russia, calling it an isolated and unique situation. He stated Vertex has a robust global IP portfolio and is taking all possible measures to enforce its rights.

David Risinger of Leerink Partners questioned if the company's M&A strategy includes acquiring royalty companies to broaden its revenue streams. He also asked about the primary gating factors for signing new ENHANZE customer deals and whether potential partners are delaying decisions pending CMS guidance related to the Inflation Reduction Act (IRA).

Answer

Dr. Helen Torley, President and CEO, clarified that the M&A focus is primarily on acquiring drug delivery platform technologies, not royalty companies. Regarding new deals, she stated the main factor is navigating the multi-step internal review processes within partner companies. She confirmed that potential IRA guidance from CMS is not a gating factor, though a favorable outcome could create new opportunities, and expressed confidence in signing a new ENHANZE deal this year.

David Risinger of Leerink Partners requested an explanation for the product sales trend, noting that sales are relatively flat in 2024 but are projected to grow significantly by 2028.

Answer

CFO Nicole LaBrosse clarified that the product sales line includes both lumpy API sales to partners and proprietary product sales. API sales are expected to decline long-term due to cost-saving initiatives passed to partners. The projected long-term growth is driven by the increasing sales of Halozyme's proprietary products, despite a typical seasonal dip seen in Q3.

Bryan, on behalf of David Risinger at Leerink Partners, asked for more details on the VAX-31 adult Phase III program timeline and inquired about the technology and clinical development path for the preclinical Group A Strep vaccine, VAX-A1.

Answer

Executive Andrew Guggenhime reaffirmed that the VAX-31 adult pivotal study will start mid-2025 with data expected in 2026, suggesting a 12-15 month timeline. CEO Grant Pickering explained that the VAX-A1 program uses Vaxcyte's proprietary site-specific conjugation technology to target Group A Strep, creating a potential first-in-class vaccine. He confirmed the program is advancing toward the clinic but did not provide a specific timeline for an IND filing.

Asked about the potential for VAX-31 to receive a preferential recommendation from ACIP, the market opportunity for a prime-boost schedule in adults, and the company's age strategy for its adult Phase III program.

Answer

The company believes VAX-31's potential to expand coverage to 95% while maintaining existing protection could warrant a preferential recommendation from ACIP. They see a growing market opportunity in adults aged 50-64, which could lead to a prime-boost schedule (prime at 50, boost at 65). For their Phase III program, they will seek a broad label for adults 18+ and will ensure adequate enrollment of at-risk individuals aged 50-64 to support a potential universal recommendation in that age group.