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Interim CEO Ian Smith explained that the current rate-limiting factor is the activation of clinical trial sites, not patient demand. He committed to communicating any changes to the existing timelines (enrollment completion in 2026, data in 2027) as soon as they become evident. He also reiterated the company's strategy of providing regular data updates at medical conferences and on earnings calls.

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President & CEO Jan Møller Mikkelsen clarified that after adjusting for about 200 patients from an early access program in Q1, the underlying new patient growth was steady from Q1 to Q2. He noted an acceleration in the conversion of prescriptions to treated patients is expected in the second half of the year. Jay Donovan Wu, EVP & President - US Market, added that it is still early in the launch and the company is focused on optimizing the entire patient funnel.

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Chief Financial Officer Scott Smith confirmed that channel inventory for YORVIPATH is minimal, averaging one to two weeks. President and CEO Jan Mikkelsen provided a personal estimate that 17% to 18% of patients would ultimately be reimbursed. EVP and President, Ascendis U.S. Jay Wu added that favorable payer policies are being established for both commercial and government plans, and approvals are occurring even without formal policies through medical exceptions, underscoring the drug's strong clinical value proposition.

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Jan Mikkelsen, President and CEO, expressed high confidence in YORVIPATH's durability, citing its unique profile as a 'true replacement therapy' that competitors are unlikely to match. Scott Smith, EVP and CFO, confirmed that achieving cash flow breakeven by the end of 2025 remains the company's goal and is achievable with current capital.

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President and CEO Jan Mikkelsen explained that the path to blockbuster status relies on SKYTROFA's premium net value per patient (approximately 3x daily therapies), its position as a preferred brand, and significant label expansion opportunities. He noted the total U.S. growth hormone market is about $1.4 billion, and upcoming filings for Adult Growth Hormone Deficiency and data for Turner Syndrome will unlock access to a much larger portion of this market.

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CEO William Lewis expressed a clear ambition for brensocatib's launch to 'fall within reach' of those successful analogs, though he did not provide formal guidance. He tempered expectations by noting the unpredictability of a first-in-disease launch. CFO Sara Bonstein added a practical reminder that revenue booking typically begins a few weeks after approval, citing the ARIKAYCE launch as precedent.

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CEO William Lewis described PVR as the most definitive primary measure of the drug's direct impact, while the 6-minute walk test is a less specific, ancillary measure. He confirmed the Phase II study is not powered for statistical significance on the 6-minute walk test but the company hopes to see a directional benefit of 15-20 meters.

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CEO William Lewis explained that PVR is the most definitive measure of the drug's direct impact, while the 6-minute walk test is a less specific ancillary measure of exercise capacity. He confirmed the study is not powered for statistical significance on the walk test but hopes to see a directional benefit of 15-20 meters. A placebo-adjusted PVR reduction of 20% would be considered a 'clear win.'

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CEO Will Lewis estimated that about 50% of the 500,000 diagnosed U.S. bronchiectasis patients have two or more exacerbations annually, noting the addressable market could be larger. CFO Sara Bonstein stated that operating expenses are not expected to decrease due to continued investments in R&D and commercial launch preparations for brensocatib, though the SG&A-to-revenue ratio should improve post-launch.

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CEO Will Lewis explained that the start of the TPIP Phase III trial in H2 2025 is contingent on three factors: trial preparation, dialogue with the FDA to confirm a single Phase III study pathway, and crucially, manufacturing optimization. This optimization aims to deliver doses up to 640 micrograms in a single capsule for patient convenience. He added that while enrolling such trials is challenging, the competitive landscape of other clinical trials is expected to be less dense by then, which could aid recruitment.

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CEO Will Lewis explained the H2 2025 trial start is timed to complete manufacturing optimization, finalize trial preparations, and confirm the regulatory pathway with the FDA, with the expectation of needing only one Phase III study. The manufacturing goal is to deliver doses up to 640 micrograms in a single, convenient capsule. He added that the competitive trial landscape for patient enrollment is expected to be less dense by the time the study begins.

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Co-Founder & CEO Chris Peetz declined to provide a specific product-level breakdown of the updated full-year guidance. However, he indicated that the revenue trends observed year-to-date are expected to generally continue through the second half of the year.

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CEO Christopher Peetz highlighted the strength of volixibat's placebo-adjusted difference, which he attributed to using a maximally efficacious dose. Regarding the MRM-3379 program, Peetz stated the company is preparing the IND and engaging with the FDA, with a more detailed update on study design to be provided later in the year.

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CEO Chris Peetz explained the market potential is based on the 50,000 male patient population in the U.S., making the $1 billion target readily achievable. CMO Joanne Quan added that the PDE4D mechanism is relevant for other conditions involving learning and memory, with Fragile X serving as the initial proof-of-concept before exploring other intellectual disability indications.

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CEO Christopher Peetz deferred detailed comment on volixibat data until its release but noted the top-line results are strong. On business development, he positioned the MRM-3379 deal as part of a long-term strategy to find overlooked value in rare genetic diseases. President and COO Peter Radovich confirmed that unlike 2023, no significant seasonal slowdown was observed for LIVMARLI in Q3 2024, with growth driven by Alagille syndrome and a strong PFIC launch.

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President and CEO Dr. Reshma Kewalramani noted that the first DPN trial for suzetrigene may complete enrollment ahead of the second. EVP and CCO Duncan McKechnie explained the augmented Gernavix investment is a reaction to strong progress in payer coverage, positive clinical feedback, and high promotional responsiveness.

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CFO Charlie Wagner clarified that the impact from the Russia issue was approximately $100 million in Q1 and is expected to be $200 million for the full year, which is fully factored into guidance. Regarding tariffs, he stated the impact is currently immaterial due to a well-balanced global supply chain with minimal China exposure and drug product manufacturing for CF primarily in the U.S. He noted this could change if sector-specific tariffs are implemented.

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CFO Charlie Wagner explained that overall growth is driven by the CF portfolio, with the U.S. benefiting from the ALYFTREK and JOURNAVX launches. He noted ex-U.S. growth is impacted by an IP issue in one country. He did not quantify the Q4 nonrecurring items but cited favorable gross-to-net in the U.S. and one-time VAT rebates internationally as contributors.

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CEO and President Dr. Reshma Kewalramani confirmed that Vertex is planning for and has had regulatory interactions to ensure povetacicept will be available for at-home, monthly, small-volume subcutaneous administration upon commercial approval, despite the current trial protocol.

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President & CCO Charlie Gayer explained that the Q2 revenue growth was a balanced mix of increased patient volume, gross-to-net improvements, and higher efficiency in paid shipments. He emphasized that the strong underlying patient demand is the key long-term growth driver. Gayer also clarified that while the one-year discontinuation rate remains stable at 60%, the overall rate is improving as tenured patients, who tend to stay on therapy long-term, now constitute a larger portion of the patient base.

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Chief Commercial Officer Charlie Gayer explained that approximately two-thirds of the paid-rate improvement was due to the IRA's impact on Medicare, with the remaining one-third from strong execution in the commercial insurance segment. He noted this was the primary factor for the guidance raise, supported by strong underlying patient growth. CEO Jon Stonehouse stated that pipeline programs are already fully funded and that the increased financial strength enabled a $75 million debt paydown to strengthen the balance sheet and reduce future interest payments.

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Chief Commercial Officer Charlie Gayer reported that the overall paid patient rate was 73.5% at the end of 2024 and that a rebound in Medicare paid patients could push this toward 80%. CEO Jon Stonehouse confirmed the pace of Medicare improvement is faster than anticipated, driving the guidance raise. Regarding Netherton, Chief R&D Officer Dr. Helen Thackray explained that skin healing could potentially be observed within a few months, possibly at 4-to-12-week assessments, after on-target drug activity is confirmed.

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Chief Commercial Officer Charlie Gayer explained that ORLADEYO's growth is currently an even split between patients switching from other prophylactics and those moving from acute-only treatment, with switches expected to drive more growth long-term. CFO Anthony Doyle stated that revenue growth will significantly outpace operating expense growth, allowing the company to fund ORLADEYO's expansion and advance its Netherton syndrome and DME trials while moving toward sustained profitability by 2026.

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CSO Ryan Richardson confirmed the INEST adjuvant CRC data timeline remains late 2025/early 2026. CMO Özlem Türeci outlined the benchmarks for the BNT327 trials and clarified that the BNT323 endometrial cancer data would be shared in early 2026 to allow for data maturation, aligning with the planned BLA submission.

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CFO Jens Holstein and CSO Ryan Richardson stated that the near-term financial impact from current tariffs is limited, though they are monitoring future policy changes. For differentiation, Richardson highlighted a two-pronged strategy for BNT327: first, aiming to be first-to-market in indications like TNBC and SCLC with chemotherapy, and second, a longer-term plan to create novel combinations with their proprietary ADC pipeline.

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CMO Özlem Türeci detailed the upcoming data pipeline for BNT327. The next major release will be for triple-negative breast cancer (TNBC), featuring maturing overall survival data. Additionally, she noted the potential for data from other cohorts, including the first results from the combination study of BNT327 with the company's TROP2 ADC, BNT325.

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CFO Jens Holstein explained the guidance adjustment was due to lower-than-expected demand and pricing in low and middle-income countries within Pfizer's territory. Chief Strategy Officer Ryan Richardson identified small cell lung cancer as a potential fast-to-market indication for BNT327, with a Phase III portion of a trial expected to start by early next year.

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CCO Tolga Tanguler described expectations for steady growth in both first-line and second-line patients. CEO Yvonne Greenstreet affirmed it is guidance they expect to achieve. CFO Jeff Poulton provided context, noting the guidance implies ~$1 billion in YoY TTR growth, with over $600 million from cardiomyopathy, a figure he expressed high confidence in given the Q2 performance.

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Chief Commercial Officer Tolga Tanguler stated that while the original goal was to complete formulary inclusion by year-end, they are well ahead of schedule. He noted the most encouraging sign is that a majority of these accounts are already initiating patients on therapy. For Q2, he said the key update will be revenue uptake and pull-through, supplemented with more color on patient and prescriber trends.

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Chief Commercial Officer Tolga Tanguler said the early competitor data is encouraging as it confirms the category is a growth story. He believes AMVUTTRA is well-positioned with its strong clinical profile and convenient dosing. CEO Yvonne Greenstreet reiterated that the market growth opportunity is what makes the category exciting.

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CEO Yvonne Greenstreet expressed confidence in Alnylam's own HELIOS-B data and regulatory strategy, regardless of the competitor's label. Chief Medical Officer Pushkal Garg added that they view acoramidis as a twice-daily stabilizer and believe AMVUTTRA's distinct mechanism of action will position it well for first-line use or for patients progressing on stabilizers.

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Dr. Leigh Peterson, VP of Product Development, clarified that treprostinil has multiple anti-fibrotic mechanisms beyond vasodilation, suggesting efficacy in IPF regardless of PH status. James Edgemond, CFO & Treasurer, added that the board authorized the $1 billion buyback due to business strength, a robust balance sheet, and confidence in upcoming catalysts, stating it would be implemented 'expeditiously'.

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Michael Benkowitz, President and COO, stated that while there was a clear year-over-year benefit from Q1 2024, the impact in Q1 2025 versus Q4 2024 is modest. He explained this is because any benefit from the lower out-of-pocket cap is largely offset by the new manufacturer obligation to contribute to catastrophic coverage, making the net effect minimal for the quarter.

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Dr. Leigh Peterson, EVP of Product Development and Xenotransplantation, explained that after a cohort of six participants, a 12-week review by a DSMB will assess safety, patient survival, and graft survival to determine the risk-benefit for continuing. Chairperson and CEO Dr. Martine Rothblatt added that it is premature to speculate on further DPF facility investments.

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Dr. Leigh Peterson, an executive in charge of Xenotransplantation, confirmed receipt of pre-IND feedback from the FDA. However, she stated that the company would not share details of the proposed clinical study design until after the IND is officially cleared by the agency.

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CEO Aaron Berg confirmed that a major payer reinstated Vascepa to an exclusive position, supporting volume expectations for the second half of 2025. CFO Peter Fishman added that U.S. net price should remain comparable to Q2, and the $70 million in cost savings will be realized on a roughly straight-line basis over the next four quarters. Regarding strategic opportunities, Berg stated that while the company is evaluating all options from a position of strength, no further details would be provided at this time.

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President and CEO Aaron Berg and CFO Peter Fishman explained that the higher Q4 net price was due to a favorable shift in business mix. This shift resulted from the volume impact of CVS Commercial moving VASCEPA to a 'not covered' status, which reduced the proportion of sales in higher-rebate channels. Fishman noted that the volume impact from this change would continue to affect year-over-year comparisons through the first half of 2025, alongside ongoing pricing pressure from exclusive contracts.

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President and CEO Aaron Berg attributed 'rest of world' momentum to nine partnerships beginning to contribute, highlighting recent launches in Australia and regulatory approval in China. He noted EU growth is driven by a strategy shift in the U.K. and strong execution in Spain. VP and Global Controller Peter Fishman added that U.S. net price pressure is expected to continue, influenced by the generic environment and a mix shift toward higher-discount Medicare Part D following the CVS formulary change.

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CEO Bill Meury described his capital allocation philosophy as rigorously 'calling balls and strikes' between internal and external opportunities with no 'sacred cows.' His five-year vision is to set a 'new high watermark' for Incyte by executing on its growth portfolio, R&D priorities, cost management, and business development, with a special focus on dominating the MPN market.

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CEO Herve Hoppenot stated that capital allocation is primarily driven by the internal pipeline, with successful proof-of-concept data leading to R&D investment in Phase III trials. He mentioned that external business development focuses on early-stage partnerships but declined to comment on future share repurchase plans.

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Pablo Cagnoni, President, Head of R&D, responded that prior biologic exposure is a stratification factor and the data will be analyzed accordingly, with label discussions to follow with the FDA. He clarified that 'close to Phase II' refers to replicating the overall positive profile of efficacy and safety, emphasizing the importance of the rapid benefit seen at the 12-week primary endpoint, rather than a specific percentage.

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Pablo Cagnoni, President and Head of R&D, stated that their BET inhibitor plans remain unchanged, emphasizing its potential for continuous dosing as a key differentiator. For CSU, he explained povorcitinib is in a Phase II proof-of-concept study, while INCB00262 is being studied across a full dose range. He positioned INCB00262 as a potential first therapy after antihistamines due to its targeted mechanism and expected clean safety profile, suggesting the two molecules could be sequenced in treatment.

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CEO Ashley Cordova explained the METIS submission is modular, a first for their torso device, requiring FDA review of initial modules before the final clinical module can be submitted, which dictates the timeline. Regarding prior period revenue, she clarified that the 3-5% range is a standard, recurring element already baked into the run rate since the adoption of the accounting standard.

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CFO Christoph Brackmann clarified the tariff impact relates to different rates on arrays imported from Israel. Executive Frank Leonard noted that while it is still early, NSCLC therapy duration appears to be in line with expectations from the LUNAR trial. CEO Ashley Cordova stated that the LUNAR-2 and LUNAR-4 trials are in early enrollment, and it is too soon to provide completion guidance.

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CFO Ashley Cordova advised using industry norms for the PANOVA-3 timeline, estimating one to two quarters to prepare the submission post-data, followed by a standard review period. Regarding gross margin, she projected it would remain in the 70% range, with the exact figure depending on the net revenue generated from the lung cancer launch. She noted the cost headwinds from new arrays would be temporary, with margins expected to return to current target levels within six to eight quarters.

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Alan Bash, President of CARVYKTI, explained that high demand exists in the community due to CARVYKTI's survival benefit. He outlined a three-pronged strategy: increasing education for community sites, connecting academic and community experts, and ensuring community physicians that referred patients will return for ongoing care. CEO Ying Huang added that upcoming long-term data at ASCO and the recent OS label addition in Europe will further drive community uptake.

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An Unknown Executive stated that growth over 2025 will not be linear. They anticipate modest growth in Q1 following a strong Q4, partly due to facility maintenance during the holidays. Meaningful step-ups in manufacturing from Raritan and the newly approved Novartis facility are expected to drive more significant growth in Q2 and Q3.

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SVP of Commercial Development, Steven Gavel, explained that the shift to outpatient use is primarily driven by treatment sites needing to absorb the increased patient volume from the second-line launch. While large academic centers are leading the adoption, new sites take time to gain experience. He emphasized that CARVYKTI's delayed CRS onset profile is a key enabler of this outpatient strategy.

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Dr. Dana Pizzuti, Chief Medical and Development Officer, confirmed the protocol was developed based on input from the FDA and other health authorities, who are aware of the final design. She elaborated that Crinetics aims for an indication positioning atumelnant as the primary treatment for CAH, allowing glucocorticoids to be used solely for physiologic replacement, which would differentiate it from existing therapies.

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CEO R. Struthers confirmed that sites for the OLE are activating and patients are enrolling. He noted that all patients had come off the drug and are now re-initiating treatment. While he stated the data will be a valuable source of information, he did not commit to a specific timeline for its release.

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CEO R. Struthers declined to provide precise timelines for Phase I data but anticipated a steady flow of information. He clarified that the ligand in CRN09682 is a distinct SST2 agonist optimized for internalization, unlike paltusotine. MMAE was chosen as a well-established cytotoxic payload, and the company is exploring alternatives for future compounds.

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Lai Wang, Global Head of R&D, confirmed that the R&D Day presentation will include safety, PK, and efficacy data from dose escalation cohorts, but durability data will be limited due to the rapid pace of enrollment. He stated that the CDK4/6 naive cohort is enrolling, but it is too early to disclose data from that group.

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Wang Lai, Global Head of R&D, confirmed that data from the dose escalation cohorts, including efficacy, safety, and PK, will be shared at the R&D Day. However, he cautioned that due to rapid enrollment of over 100 patients in the last two months, durability data will be limited. He also stated that the CDK4/6 naive cohort has begun enrolling patients, but it is too early to disclose that data.

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Global Head of R&D Lai Wang downplayed the immediate competitive threat, arguing the trial designs use non-standard comparators (chemoimmunotherapy, ibrutinib) and endpoints (ORR) that are unlikely to be practice-changing. She highlighted BeiGene's confidence in its own BTK degrader, which is planned for a head-to-head trial against pirtobrutinib.

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Renée Galá, President and COO, detailed the global manufacturing sites, including the U.K. for Epidiolex and various European locations for oncology products. Phil Johnson, CFO, added that the company holds sufficient U.S. inventory to cover nearly all of its 2025 needs for every product, providing a significant buffer against potential tariffs, and is exploring further options with U.S.-based contract manufacturers.

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Robert Iannone, EVP and Global Head of R&D, confirmed that enrollment completion refers to the 918-patient target. He explained that while the company remains blinded, a slower event accrual could be a positive sign if the experimental arms are outperforming, but this cannot be confirmed. He added that the control arm has been consistent in three prior Phase III trials, suggesting it is likely behaving as expected.

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EVP, Global Head of R&D Rob Iannone confirmed the upcoming enrollment completion refers to the upsized 918-patient target. He explained that while the company is blinded, a slower event rate could be a positive sign if the experimental arms are effective, but it's not definitive. He expressed confidence in a data readout in H2 2025.

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President and COO Renée Galá confirmed that the field nurse educator program is enhancing patient persistency. She noted that while narcolepsy patient additions can vary quarterly, the current demand is strong, stemming from new patient starts and transitions from high-sodium oxybates, driven by a growing appreciation for Xywav's low-sodium profile.

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President and COO Renée Galá confirmed the positive impact of the field nurse educator program on patient persistency. She noted that while narcolepsy adds can be variable, the current demand is strong, driven by new patient starts, transitions from high-sodium oxybates, and a growing appreciation for Xywav's low-sodium profile, which is a key differentiator.

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Dr. Helen Torley, President and CEO, expressed confidence that Phesgo will continue its strong market adoption. She highlighted its convenient administration, high patient satisfaction, and upcoming long-term data. She noted that Phesgo's conversion share reached 47% and is expected to exceed 50% in 2025, stating that patients who switch to the subcutaneous version tend to remain on it, supporting projections for continued strong growth.

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President and CEO Dr. Helen Torley stated that the partner wishes to remain confidential and could not provide a timeline for disclosure. CFO Nicole LaBrosse clarified that Halozyme defines 'mid-single digits' as a royalty rate range of 3% to 7%.

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Cristin Hubbard (CCO) and Greg Friberg (Chief R&D Officer) outlined a two-part strategy. Commercially, the focus is on a 'start-and-stay' paradigm driven by a growing body of real-world evidence, an infant label, and a broad global footprint. From an R&D perspective, they will continue to generate and publish data on health benefits beyond height and advance the next-generation asset, BMN 333, to secure the franchise's long-term value.

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CEO Alexander Hardy stated that business development is a key priority, with the company evaluating a range of preclinical and clinical assets that leverage its global commercialization strengths. CFO Brian Mueller addressed the second question, stating there were no specific Q1 ordering patterns to highlight but reiterated that overall 2025 revenue growth is expected to be weighted to the second half of the year.

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EVP, Chief Financial Officer Brian Mueller explained that the lower gross margin was driven by two factors: a higher mix of lower-margin Aldurazyme revenue and inventory reserves for gene therapy raw materials due to the pause in Roctavian manufacturing. EVP, Worldwide R&D Greg Freiberg confirmed that only single ascending dose PK data for BMN 333 is committed for 2025.

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CEO Richard Pops stated that while pricing contributes, the majority of expected sales growth is driven by volume. He also clarified that the Medicaid payer mix is relatively similar for all three products, falling in the 45% to 50% range.

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COO Blair Jackson clarified that the INVEGA SUSTENNA U.S. royalty expired in August 2024, causing a reset to lower ex-U.S. rates in Q1 2025. He noted that the INVEGA family of products typically contributes about 40% to 50% of the total manufacturing and royalty revenue line.

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CCO Todd Nichols specified the new access impacts ~11 million commercial lives and expects the gross-to-net to move into the mid-30s over the course of next year, not in a single step-up. He attributed ARISTADA's Q4 outlook to prescriber breadth and non-retail business growth. COO Blair Jackson noted the company views its stock as undervalued and will be opportunistic with the remaining $200M repurchase authorization, balancing it against cash needs for the business and BD.

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Chief Global Product Strategy Officer Kyle Jenne confirmed that Q1 TRYNGOLZA sales were driven by demand with minimal inventory stocking. CFO Beth Hougen specified that the vast majority of the revenue guidance increase was due to licensing deals for sapablursen and olezarsen. CEO Brett Monia detailed that manufacturing sources in the U.S., Europe, and South Korea provide a robust supply chain, and stated that tariffs have not had a meaningful impact on the business to date.

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Chief Global Product Strategy Officer Kyle Jenne stated that WAINUA is performing strongly, capturing approximately 40% of new-to-brand patient starts. He highlighted accelerating quarterly growth, broad prescriber adoption from both specialists and community physicians, and a patient mix that includes naive, switch, and combination therapy users, setting up a strong outlook for 2025.

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CEO Brett Monia explained that the timeline shift is due to a strategic decision with partner AstraZeneca to run the study to its full completion, with all patients followed for 140 weeks, to generate the most robust and comprehensive dataset possible. He confirmed this decision, rather than an earlier readout, accounts for the H2 2026 timing after data finalization.

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President Stephen Hoge addressed the clinical questions, stating no delays are expected for Norovirus internationally and that CMV data is possible mid-2025. CFO Jamey Mock detailed the revenue guidance: the $2.5B high end assumes flat performance, while the $1.5B low end assumes lower COVID share and vaccination rates, plus delays in international manufacturing licensure.

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David Berman, Head of R&D, stated that dose selection will be based on safety, requiring a well-tolerated regimen, and evidence of antiviral activity. He outlined that the typical next step is a randomized Phase II trial with a placebo, although recent literature suggests single-arm trials could be a possibility. CEO Bahija Jallal added that the company will consult with regulatory authorities before finalizing its plans.

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