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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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."

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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