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Chief Commercial Officer Johanna Mercier detailed a flexible, multi-channel approach prepared for the launch. This includes options for clinics to use buy-and-bill, send prescriptions to a specialty pharmacy for fulfillment, or refer patients to an alternate site of care. She highlighted the success of their 'pod' model, where cross-functional teams (including nurse educators and reimbursement specialists) meet with clinics together to streamline the process and answer all logistical questions at once, which has been highly effective and appreciated by customers.

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Chief Commercial Officer Johanna Mercier explained that Gilead offers flexibility: physicians can use buy-and-bill, prescribe via specialty pharmacy, or refer to an alternate care site. She noted a key success factor is the use of cross-functional 'pods' (sales, medical, reimbursement) that meet with clinics together to simplify the process and answer all logistical questions at once, which has been received very positively by customers.

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CEO Daniel O'Day stated that it is too early to speculate on Medicaid and that no impact has been seen from funding discussions that would alter their HIV launch plans. CCO Johanna Mercier added that Gilead is prepared to accelerate its own community and education programs to fill any potential gaps. Regarding Medicaid, she expressed confidence that HIV patients would find other coverage channels if needed, supported by state and Gilead programs, due to the critical nature of the therapy.

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Chief Commercial Officer Johanna Mercier explained that while strong demand was the primary driver, the inventory build in 2024 was more concentrated in Q4 compared to 2023, when it was spread across Q3 and Q4. This timing difference accounted for the year-over-year dynamic.

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Kenneth Custer, President of Lilly Cardiometabolic Health, stated that the gender split was approximately 64% female, which was well-balanced across all study arms. He concluded that there was 'nothing really to remark on' regarding the demographic.

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CEO David Ricks suggested the questions were better directed to competitors and CVS but noted the formulary change applies to a smaller book of business with low employer opt-in rates. He acknowledged the possibility that a lower net price from a competitor could increase employer opt-ins, which would be a net positive for the category. However, he reiterated Lilly's focus on innovation and differentiation, stating that reducing patient choice seems like the wrong approach for this market.

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Executive Patrik Jonsson acknowledged the need for significant medical education. He said efforts are starting with the receptive sleep specialist community but that the strategy requires moving into primary care to reach the large, undiagnosed patient population.

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Patrik Jonsson, President of Lilly Cardiometabolic Health and Lilly USA, reported strong access for Mounjaro (93%) and Zepbound (nearly 90% commercial), with a positive trend in employer opt-ins and growing Medicaid coverage. Ilya Yuffa, President of Lilly International, added that OUS access is also progressing well in key markets for both reimbursed and self-pay channels.

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CCO Peter Heerma stated the conversion rate is at the top end of rare disease benchmarks and that the key opportunity is in the 70% of patients with proteinuria below 1.5 g/g. CEO Dr. Eric Dube noted that penetration is still below 10% of the addressable market, leaving significant room for growth. Regarding competition, Heerma expressed confidence that Filspari will remain the market leader due to its strong, recognized profile.

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CCO Peter Heerma explained that their strategy involves targeting approximately 6,000 of the 10,000 U.S. nephrologists, who collectively treat about 85% of IgAN patients. He noted that many of these physicians have 5-10 IgAN patients. CEO Eric Dube added that unlike other rare diseases, IgAN is not highly concentrated in a few centers, which requires a broad commercial reach but also signals a substantial, untapped opportunity for growth.

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EVP & CFO Dave Denton explained that while the EPS guidance was raised by $0.30 on an operational basis, the company is choosing to de-risk the second half of the year. He cited the potential volatility of COVID-19 revenues, which are concentrated in Q3 and Q4, as the primary reason for prudently holding the revenue guidance at this time.

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CFO Dave Denton explained that while the underlying business strength is strong, allowing for a 30-cent EPS guidance raise (before the 3S Bio charge), the company believes it is prudent to hold revenue guidance steady. This approach derisks the second half of the year, particularly given the potential volatility in COVID-related revenues.

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CEO Albert Bourla responded that for products deemed critical to national security, the administration is looking at the entire value chain, including precursors and APIs. He acknowledged that transferring manufacturing is a multi-year process, suggesting the focus would likely be on a manageable number of the most vital products.

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Executive Alexandre de Germay noted strong international performance, with Prevnar 20 rapidly recapturing share where approved, such as in Japan. Executive Aamir Malik stated that in the U.S., Pfizer expects to maintain meaningful adult market share despite new competition and sees growth opportunities in the 50-64 age group, while the pediatric market remains stable with high share.

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An executive, likely Chief U.S. Commercial Officer Aamir Malik, confirmed that Pfizer worked with channel partners to ensure appropriate stocking in Q3 to prepare for the vaccination season. He emphasized that performance is also being driven by strong execution and a significant increase in market share, which reached 43% in the retail setting by mid-October.

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President and CEO Dr. Reshma Kewalramani confirmed that Vertex has not received a letter regarding this matter. She added that the company maintains open lines of communication with Washington D.C. and is closely monitoring the situation.

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CEO Dr. Reshma Kewalramani clarified that the mechanisms are entirely different: gabapentinoids like Lyrica are CNS depressants, whereas suzetrigine specifically targets NaV1.8 pain channels in the peripheral nervous system. She noted that while Lyrica is approved for DPN, it is not approved for LSR in the U.S.

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EVP & Chief Commercial Officer Jeffrey Stewart explained that while some patient movement occurs, the primary driver for SKYRIZI and RINVOQ growth is their strong clinical data, making the biosimilar impact minor. CEO Robert Michael reinforced this, noting SKYRIZI's share gains against STELARA pre-dated the biosimilar launch due to superior head-to-head trial results.

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CSO Roopal Thakkar explained that AbbVie is thinking broadly about the Amylin program's potential. As a monotherapy, its tolerability could be key to addressing high discontinuation rates seen with current assets. It could also serve as a follow-on therapy. For combinations, the asset's neutral pH formulation is an advantage, and AbbVie remains interested in adding other mechanisms to drive further weight loss while prioritizing tolerability and durability.

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EVP & CCO Jeffrey Stewart explained that while some volume comes from Humira switches, the primary driver is buoyant market growth fueled by the expansion of second and third lines of therapy, especially in atopic dermatitis and IBD. CEO Robert Michael provided specific market growth projections: high single-digits for psoriasis and IBD, mid-teens for atopic dermatitis, and low-to-mid single digits for rheumatoid arthritis.

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CSO Roopal Thakkar explained that confidence stems from SKYRIZI's very high endoscopic improvement rates in naive ulcerative colitis patients. He stated the trial will aim for superiority on the objective endpoint of endoscopic improvement, which is highly predictive of long-term outcomes.

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EVP & CFO Caroline Litchfield clarified that the revenue midpoint was maintained. A modest FX tailwind was offset by headwinds, including lower COVID cases impacting Lagevrio and an early biosimilar entry for pembrolizumab in Argentina. She reiterated confidence in the underlying business growth of 6-8% when excluding Gardasil in China.

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EVP & CFO Caroline Litchfield clarified that the midpoint of the revenue guidance was maintained. She explained that a modest foreign exchange tailwind was offset by headwinds from lower-than-expected COVID cases impacting Lagevrio and an early biosimilar entry for Januvia in Argentina. She reaffirmed confidence in the underlying business growth of 6-8% when excluding the Gardasil China impact.

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Dr. Dean Li countered by highlighting first-in-class acquisitions like Acceleron and EyeBio, and framed other deals as part of a coordinated strategy combining external assets with Merck's internal pipeline. CEO Robert Davis reinforced this, describing the strategy as balanced between first-in-class and best-in-class opportunities.

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CEO Robert Davis declined to specify inventory levels, citing Zhifei's status as a public company. He explained the intent of the shipment pause is to accelerate the inventory drawdown and improve Zhifei's financial position. He reframed the situation by noting that after this rebasing, GARDASIL in China represents only about 1% of Merck's total revenue, making any future recovery an upside to the company's growth story.

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Dr. Dean Li explained that the strategy leverages KEYTRUDA's proven efficacy in earlier-stage cancers. The V940 lung cancer trial is specifically designed for patients who do not achieve a pathological complete response after perioperative KEYTRUDA-based treatment. This patient population represents a clear unmet need, providing a strong rationale for testing a new combination therapy like V940.

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Executive Dave Gancarz deferred comment on the HARMONi-2 OS subgroup analysis to their partner Akeso. For indications beyond lung cancer, Gancarz pointed to promising Phase II data in microsatellite stable colorectal cancer and triple-negative breast cancer. Chief Medical Officer Dr. Allen Yang added that the company has a clear plan based on scientific rationale and Akeso's data. Dr. Jack West noted that ivonescimab's cooperative binding mechanism, not just its VEGF component, may be key to its efficacy in tumors where PD-1 inhibitors have previously failed.

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Executive Dave Gancarz deferred the HARMONi-2 subgroup question to partner Akeso. For other indications, he pointed to Akeso's Phase II data in areas like microsatellite stable colorectal cancer. Chief Medical Officer Dr. Allen Yang added that their expansion plan is driven by Akeso's Phase II data and where VEGF/PD-1 activity overlaps. Dr. H. Jack West, VP, noted ivonescimab's cooperative binding mechanism may also be key to its broad potential.

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An executive explained that safety run-ins are standard for any new combination. Dr. Allen Yang, Chief Medical Officer, added that emerging data with similar combinations suggest feasibility and they don't expect surprises. Dr. Yang also clarified that HARMONi study patients were eligible regardless of prior TKI sequencing and they expect no efficacy differences. An executive pointed to the Phase II AK112-201 data as the best early indicator for the ivonescimab plus chemotherapy combination.

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Bruce Cozadd, Chairman and CEO, clarified that the primary strategy is not to replace the frontline standard but to position zanidatamab *after* ENHERTU, which is moving into the frontline setting. He emphasized that the ongoing EmpowHER BC 303 trial is designed to show activity in this post-ENHERTU setting, a space where no other HER2 therapies are being evaluated, representing a very meaningful opportunity.

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Robert Iannone, EVP and Global Head of R&D, clarified that Ziihera aims to be the HER2 agent of choice regardless of PD-L1 status. He explained that for the triplet regimen to be approved, it must demonstrate superiority over the control arm (Arm A) and a favorable benefit/risk profile compared to the doublet arm (Arm B), but a direct statistical win of Arm C over Arm B is not a required component of the trial design.

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EVP, Global Head of R&D Rob Iannone argued that the standard of care remains Herceptin-chemo for a high proportion of patients. He stated that Ziihera aims to be the HER2 agent of choice regardless of PD-L1 status. For the triplet arm to be approved, it must be superior to the control arm (Arm A) and offer a better benefit/risk profile than the doublet arm (Arm B).

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CEO Bruce Cozadd gave a direct response, stating, 'It's entirely due to that temporary impact we're seeing on Rylaze. That's what drove the change.'

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CEO Bruce Cozadd provided a direct response, confirming that the revision to the oncology guidance was entirely attributable to the temporary revenue impact on Rylaze resulting from the updated treatment protocols.

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CFO Matthew Abernethy confirmed the Medicare Part D redesign provided a slight tailwind of about 1%, but this was more than absorbed by new contracting. CMO Dr. Eiry Roberts detailed that the first NBI-'568 Phase III study is U.S.-only, uses a simple 1:1 randomization against placebo with the 20mg dose, and leverages learnings from Phase II to maintain efficiency.

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Chief Financial Officer Matthew Abernethy clarified that new contracts with incremental rebates largely offset the annual price increase, resulting in a 'flattish' year-over-year price. He confirmed the guidance range does include the expected benefit from the sales force expansion, which is anticipated to build momentum in the second half of the year, with the high end of the range reflecting a quicker contribution.

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CEO Kyle Gano explained that Crinecerfont works upstream to regulate the HPA axis by controlling ACTH, which in turn reduces androgens and allows for lower glucocorticoid use. He positioned the competitor's ACTH antagonist as working downstream, focusing only on androgens. He expressed confidence in Crinecerfont's position due to its strong efficacy and safety data in both adults and children.

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CMO Özlem Türeci stated the Phase II portion will conclude later this year, providing the dose for the Phase III portion, which will also begin this year. She explained the PD-L1 component was deliberately chosen for its potential for superior anchoring in the tumor microenvironment, and the molecular format was selected for optimal cross-ligation.

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CEO Ugur Sahin detailed their distinct approach for the BNT327 non-small cell lung cancer trial. He described it as a comprehensive study covering the full spectrum of first-line patients, including PD-L1 high, low, and negative populations across both squamous and non-squamous histologies. The trial uses pembrolizumab plus chemotherapy as the comparator arm.

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Greg Friberg, Chief R&D Officer, clarified that while the 10% dystrophin level at steady state is a key goal, the decision will be informed by the totality of data, including safety and PK. He noted that a model predicts the initial 25-week data will provide a line of sight to achieving that goal, and that functional outcomes, while being measured, will be more informative later in the study.

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EVP, Worldwide R&D Greg Freiberg noted that while there are too many variables to define the Phase III design for BMN 333 now, there are scenarios where the timeline could be accelerated if the product profile is strong. EVP, Chief Financial Officer Brian Mueller explained that Naglazyme's performance, which benefited from some order timing, exemplifies the durability of the ERT portfolio, with future growth expected from new initiatives not yet implemented.

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CEO Christopher Boerner asserted that his confidence in the internal R&D pipeline remains unchanged, noting the recent setbacks have minimal financial impact and do not alter the company's long-term growth prospects. Chief Medical Officer Samit Hirawat highlighted the R&D organization's high productivity, citing 43 major approvals in five years and a plan for over 10 new molecular entities by the end of the decade.

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CFO David Elkins confirmed that Eliquis will see favorability in the U.S. from the Part D redesign, which will invert its historical sales pattern, making Q1 the lowest quarter and the second half of the year stronger than the first. Despite this quarterly shift, he affirmed that the company expects strong double-digit growth for Eliquis for the full year, driven by its growing market share.

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Head of Global Drug Development Samit Hirawat explained that while the current AD psychosis program uses three-times-daily dosing, the company is actively developing a twice-daily (BID) formulation for new studies and is planning a bridging program to incorporate it into the ongoing AD psychosis study. He cited the drug's dual M1/M4 mechanism as the basis for its potential in cognition.

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CFO Nicole LaBrosse attributed the sequential royalty decline to annual contractual rate resets, primarily for DARZALEX, which temporarily lowers the rate at the start of the year. President and CEO Dr. Helen Torley added that the company's guidance already incorporates the potential upside from the VYVGART prefilled syringe, as it is based on projections provided by their partner, Argenx.

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CFO Nicole LaBrosse stated that the focus is on the current year's guidance, with 2025 details to come in the new year. President and CEO Dr. Helen Torley clarified that MDASE covers different molecular structures and a distinct patent portfolio from ENHANZE. Therefore, licensing MDASE does not conflict with or infringe upon exclusive ENHANZE partner agreements.

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Executive Jon Congleton highlighted the tight concordance between measurement methods in the Target-HTN trial but was hesitant to project a direct read-through from Advance to Launch due to differing study designs. He reiterated strong confidence in 24-hour coverage, noting that morning trough measurements in Target-HTN showed a significant effect. Chief Medical Officer Dr. David Rodman added that the 10-12 hour half-life is considered ideal for balancing efficacy with a restoration of normal circadian rhythm.

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Executive Jon Congleton stated that while Launch-HTN demographics haven't been released, he doesn't expect the global nature to dilute the BMI effect, as the obesity-hypertension link is strong worldwide. CMO Dr. David Rodman added that they will distinguish between African-American and European Black populations due to genetic differences. He also confirmed that Launch-HTN is 'super powered,' making any potential increase in placebo variability a non-significant issue.

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Murdo Gordon, EVP of Global Commercial Operations, confirmed that due to settlement timing, the erosion is expected to be more back-half loaded. He suggested the erosion curves could differ between XGEVA (oncology) and Prolia (osteoporosis) and stated that Amgen's incumbency and market leadership position them well to defend the brands.

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EVP of R&D James Bradner (misattributed as Murdo Gordon in transcript) responded that while they expect some insights into anti-diabetic activity from the current study, a dedicated Phase II trial in diabetes patients (particularly those without obesity) is necessary for a full characterization, and that study has been initiated.

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EVP of Commercial, Marion McCourt, did not provide a specific cadence but highlighted the growth opportunity from both naive and switch patients. CEO Dr. Leonard Schleifer pivoted the conversation to the broader pipeline, emphasizing upcoming data in COPD, melanoma, and myasthenia gravis to underscore the company's diversified growth strategy.

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President and CEO Dr. Leonard Schleifer stated that while the company doesn't give specific guidance on conversion rates, he feels the progress is solid and expects it to continue. He reiterated that key catalysts for acceleration next year include potential approval in RVO and, more importantly, the launch of the prefilled syringe by mid-year. He noted that original EYLEA remains a sticky product due to physician familiarity and trust.

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Sravan Emany, COO and CFO, explained that the expected Q4 profit increase is due to the brand's historical cyclicality, with Q4 typically being the strongest quarter. He attributed the charge reversal to timing differences in recording gross-to-net adjustments with partner AbbVie, which are expected to balance out by year-end.

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COO & CFO Sravan Emany explained that since Q1, Medicaid utilization has been even higher than anticipated due to lower-than-expected impact from redeterminations, the AMCAP repeal, and state-level eligibility changes, necessitating the revised guidance. Chief Medical Officer Michael Shetzline clarified that the current CNP-104 study is the first-in-human for PBC, distinguishing it from a past study on the COUR platform for celiac disease.

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CFO Sravan Emany responded that the 2024 guidance accounts for the anticipated channel mix for the full year and reiterated that the expected net sales decline is predominantly driven by the one-time adjustment. CMO Michael Shetzline explained that CNP-104's mechanism is distinct from precedents, as it targets the root cause of PBC. He stated that while they believe there is an opportunity to see an early clinical signal at 120 days, they will learn from the data.

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