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Harith Rajagopalan, Co-Founder, CEO & Director, stated the update will cover safety, tolerability, and weight maintenance effectiveness, with enough detail to assess the pivotal study's outlook. He clarified that DEXA scans occur at six and twelve months, not three. Regarding Rejuva, he noted that GMP product lot release is weeks away and the company remains on track for preliminary data in 2026.

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CFO & COO Michael Kaseta declined to project gross-to-net but noted that as new-to-market blocks are removed with major payers, more prescriptions will be subject to rebates. He attributed the non-converted scripts primarily to temporary headwinds like these blocks, which are expected to ease. He also stated the company will not rely on Symphony data for reporting and will provide its own metrics on quarterly calls.

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CFO Michael Kaseta expressed confidence in achieving broad market access for YUTREPIA close to launch, citing ongoing payer engagement. Chief Medical Officer Dr. Rajeev Saggar confirmed the INCREASE study is a 'replicable' model for the L606 trial, which is planned as a global study with 300-400 patients. CEO Dr. Roger Jeffs added that L606's unique formulation should enable higher dosing and potentially superior outcomes compared to those observed in the INCREASE study.

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CFO Michael Kaseta affirmed confidence in the company's $133 million cash position to fund all current objectives, including the YUTREPIA launch and clinical trials, but noted they can make decisions to adjust spending if necessary. General Counsel Russell Schundler stated that the company does not currently anticipate filing a public response to the citizens' petition, handling any necessary communications directly with the FDA.

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President and CEO Ian Mortimer confirmed that blinded patient characteristics in EXTOL-two look very similar to the original EXTOL study and stated they will not use induced pain challenges in Phase I due to variability. Chief Medical Officer Christopher Kenney noted there would be some site overlap between the MDD and BPD trials to leverage resources, but it is not a primary driver of the strategy.

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President and CEO Ian Mortimer deferred specifics on the BPD trial design (mono vs. adjunctive) until closer to the study's initiation. Regarding the next-gen Kv7 program, he explained that since Azetukalner has a strong profile, the goal is not to fix a specific problem but to build on its success. He sees the potential for these new molecules to be used in both existing indications like epilepsy and neuropsychiatry, as well as new areas like pain.

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CFO Sherry Aulin expressed high confidence in their patent portfolio, which extends to 2039/2040. She noted the food effect is unique to azetukalner and not a class effect. Because the drug has been consistently dosed with food in all Phase II and Phase III trials, the company reasonably expects this instruction to be included in the final product label, which is key for both efficacy and tolerability.

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Interim Chief Medical Scientist Bruce Given clarified that comparing pancreatitis event data is difficult because Arrowhead counts true adjudicated cases, whereas the competitor includes less specific abdominal pain events. He emphasized that pancreatitis is the more severe and important measure and confirmed Arrowhead will publish its baseline demographics at a future medical conference.

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Interim Chief Medical Scientist, Dr. Bruce Given, explained that labeling negotiations with the FDA have not yet occurred. He highlighted that Arrowhead's PALISADE study used stricter, confirmed pancreatitis criteria, which could be a key differentiator. President and CEO, Dr. Christopher Anzalone, added that the primary goal is lowering triglycerides, noting the impressive reductions achieved in the Phase III study.

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Andy Davis, SVP and Head of Global Cardiometabolic Franchise, expressed strong confidence in the FCS launch, calling plozasiran a 'game changer' and expecting a return on investment within that timeframe. He also highlighted the significant physician overlap between FCS and SHTG, meaning the initial launch activities will directly support the future, broader indication.

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President and CEO Dr. Christopher Anzalone positioned the facility as one of several tools to bridge to SHTG commercial revenue, noting some but not all future deal proceeds might be used for repayment. Regarding ARO-TSLP, Dr. Anzalone and Dr. James Hamilton clarified it was primarily investigated as a component for a future dimer therapeutic, not as a standalone program, and that RAGE is mechanistically upstream of TSLP.

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Chief R&D Officer Philippe Martin explained that MR-141's different mechanism of action should provide a better safety profile than existing treatments. CCO Corinne Le Goff added that its unique profile is a great opportunity for their Eye Care business. CFO Doretta Mistras attributed the gross margin improvement to a reduced impact from the Indore facility issues and a more favorable product and segment mix, noting margins were in line with expectations.

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CEO Scott Smith explained that active remediation at the Indore facility can cause manufacturing pauses and supply shortages for certain products shipped to markets like Europe. CFO Theodora Mistras stated the $450M-$550M new product revenue range is 'derisked,' with 20% from already approved products. Chief Commercial Officer Corinne Le Goff added that Breyna is expected to remain a key contributor in 2025.

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CEO Scott Smith stated that Viatris could not comment on another company's investigation but emphasized Viatris's high internal standards and strong compliance structure in China. Chief R&D Officer Philippe Martin added that a meeting with the FDA regarding GA Depot is set for mid-December, with an update expected next year, and that the Sandostatin LAR generic is still under review with a launch anticipated next year.

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EVP & CCO Jeff Del Carmen and CMO Dr. Will Andrews clarified that Elevidys developments do not impact Agamry, as corticosteroids are a foundational and different modality of treatment. President & CEO Richard Daly and Jeff Del Carmen explained the NCCN guideline impact would follow a cadence, starting with frictionless testing, then embedding the guidelines into oncology care pathways, with a commercial revenue increase expected in the second half of 2026 and beyond.

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CFO Michael Kalb and CEO Richard Daly reiterated that while the year-over-year comparison was flattered by the Q1 2024 Change Healthcare incident, the underlying organic growth for FIRDAPSE remains in the 15-20% range. CCO Jeffrey Del Carmen repeated that the focus for the SCLC-LEMS segment in 2025 is on establishing screening programs, with patient growth expected to materialize in 2026.

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CCO Jeffrey Del Carmen stated that the small cell lung cancer LEMS patient mix is stable at 20-25% of total patients and that the pipeline of approximately 500 diagnosed patients has been consistently replenished for the last 2-3 years. CEO Rich Daly affirmed that EMFLAZA remains a good surrogate for AGAMREE's potential, though Catalyst believes it has a superior product, which the SUMMIT study aims to prove over time.

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CFO Jeff Farrow advised that using last year's Q3-to-Q4 growth rate would be too aggressive given the higher current baseline, expecting more measured growth. CCO Aziz Mottiwala stated the new prescriber mix is consistent with the overall base (approx. 60% optometry, 40% ophthalmology). CEO Bobak Azamian noted it's too early to provide a new peak sales figure but expects Xtendi to be one of the largest eye drops ever.

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Chief Operating Officer Seshadri Neervannan stated that while the FDA guided to a Phase III study with 'thousands of patients,' the final design and cost will be determined after the Phase II study is complete. Chief Commercial Officer Aziz Mottiwala noted it is too early to segment the prescriber base, as the focus in 2024 was on broad adoption, and the 2025 goal is to drive prescribing depth with the newly expanded sales force and improved market access.

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CEO Bobak Azamian characterized the Part D expansion as a steady build throughout 2025 rather than an immediate "light switch" effect, citing Q1 plan resets as a moderating factor. He stated that they do not expect payer pushback on retreatments, as the potential for multiple treatments per year was factored into contracting discussions, and retreatment itself validates the drug's effectiveness for that patient.

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Head of Research & Investments Marshall Urist confirmed the frontline PDAC opportunity is exciting and was contemplated in the deal structure, with a funding tranche tied to positive Phase III data in that setting. CFO Terrance Coyne explained that the guidance range incorporates a variety of scenarios, citing Promacta generics, Part D redesign, and FX as key factors, rather than a single variable.

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EVP Marshall Urist highlighted that the Tourette's market has lacked innovation and that the tardive dyskinesia market is an interesting parallel for how a new therapy can drive market growth. EVP, CFO Terrance Coyne stated that the company could not comment on the timing of any potential dispute resolution with Vertex.

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EVP, Head of Research and Investments Marshall Urist stated that the portfolio's overall IRA exposure is modest and that the impact on key products like Imbruvica, Xtandi, and Trelegy was expected. EVP and CFO Terrance Coyne addressed the Vertex question by stating he could not provide specifics on the arbitration process or the likelihood of an alternative resolution at this time.

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Juan Camilo Ferreira, Head of R&D, confirmed that due to the lack of an efficacy signal with 6219, the backup molecule program has also been discontinued. Regarding Nexplanon, he stated Organon doesn't comment on future FDA decisions but is working to get the right labeling. CEO Kevin Ali added that the market would likely move securely to the five-year product, creating another hurdle for potential generics.

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CFO Matt Walsh detailed 2025 onetime costs, including ~$150M for manufacturing separation and ~$200M for restructuring. For NEXPLANON, CEO Kevin Ali and Head of R&D Juan Camilo Arjona Ferreira expressed confidence, citing a strong applicator patent through 2030 and significant regulatory hurdles for a generic, including demonstrating bioequivalence and applicator safety, which they believe sets a very high bar for FDA approval.

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CFO Matt Walsh explained the savings come from holistic organizational streamlining, with 75% impacting OpEx and 25% COGS in 2025. CEO Kevin Ali reiterated that NEXPLANON's growth to $1.5 billion by the decade's end will be driven by high single-digit growth, with some years potentially hitting low double-digits, making the 'greater than $1 billion' 2025 forecast a prudent target.

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Chief Financial Officer Matthew Walsh explained that Organon is onboarding approximately $240 million in costs, and the $180 million OpEx figure for 2025 reflects synergies and the roll-off of prior R&D costs. Chief Executive Officer Kevin Ali addressed the petition by emphasizing NEXPLANON's applicator patent protection until 2030 and the significant infrastructure investment required for any generic competitor, suggesting a long runway for the brand.

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Chief Medical & Scientific Officer Dr. Kumar Budur emphasized the strong data for the irritability subscale as a key secondary endpoint, citing a recent presentation showing sustained benefit. He highlighted very high adherence, with over 90% of eligible patients from prior studies opting into the long-term extension, and noted the product's favorable tolerability profile. He did not have the specific discontinuation rate from the CONNECT study immediately available.

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Dr. Kumar Budur, CMSO, confirmed the presentation will include comprehensive preclinical data with standard metrics like sleep latency, supporting the drug's high potency. CEO Dr. Jeffrey Dayno explained that because narcolepsy is a rare disease, covering multiple branded therapies for a small number of patients per plan has not been a significant budget issue or challenge for payers.

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Chief Medical and Scientific Officer Dr. Kumar Budur stated that while they have not tested the competitor's compound directly, their own assets (EPX-100 and EPX-200) showed great efficacy in the model. CEO Dr. Jeffrey Dayno declined to comment on active litigation but clarified the Markman hearing's purpose is to establish claim construction for the case, reiterating confidence in the company's IP portfolio.

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EVP and CCO Cristin Hubbard acknowledged that HCH patients are often diagnosed later but stressed a significant unmet need exists due to comorbidities. EVP and R&D Officer Gregory Friberg added that the pivotal study includes patients from age 3 to 18, an infant study is ongoing, and the company is working to publish data on the condition's healthcare burden to create an urgency to treat.

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EVP & CCO Cristin Hubbard acknowledged that HCH patients are diagnosed later but stressed there is still a large unmet need due to comorbidities. She said BioMarin is focused on educating about this need to encourage earlier diagnosis. EVP & Chief R&D Officer Gregory Friberg added that the company is actively working to publish data on the healthcare burdens of HCH to create an urgency to treat.

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Chief Financial Officer Nick Pizzie explained that Q2 revenue included initial wholesaler stocking orders with a gross-to-net in the low 80% range. Chief Commercial Officer Ari Maizel added that they are already seeing covered claims, so not all patients are relying on co-pay support, though refill velocity will be lower than Auvelity's.

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Herriot Tabuteau, CEO, clarified that the study subgroup was defined as patients with *severe* EDS to ensure specificity, whereas the broader MDD with EDS population is estimated at 50%. Regarding the peak sales guidance, he stated that the current sales trajectory is a key variable to watch and that the company feels the stated range is very achievable.

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CEO Dr. Herriot Tabuteau stated that the ADHD market is large and underserved, representing a sizable opportunity regardless, and that the company looks forward to seeing the data. He confirmed that generating pediatric data is required for an NDA submission and that the company is in the process of getting FDA feedback on its pediatric study plan.

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An executive, likely CCO Ari Maizel, responded that Auvelity is positioned as a first or second-line monotherapy, distinct from later-line adjunctive atypicals. Regarding ADA, the strategy is to leverage strong payer relationships developed for Auvelity and Sunosi to help mitigate out-of-pocket costs for a future ADA launch, though it is premature to specify co-pay amounts.

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CFO Jean-Jacques Charhon explained that deleveraging and reinvesting in the business, such as the recent Direct Corporation acquisition agreement, are the primary capital allocation priorities, moving share buybacks to the "back burner." CEO Thomas Appio clarified that the current DTC investment is focused on the OHE indication for XIFAXAN, which is driving significant volume growth and new patient starts.

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CEO Thomas Appio explained that moving Solta's highly precise manufacturing from the U.S. is difficult in the short term but is a long-term consideration. CFO JJ Charhon stated the onetime EBITDA benefits were related to expense timing and gross-to-net adjustments. He reiterated that the primary capital allocation priority is optimizing the capital structure, but given the current stock price, share buybacks are being evaluated as an option to unlock shareholder value.

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Interim CFO John Barresi confirmed that managing the 2027 and 2028 maturities is a key focus. CEO Thomas Appio defended XIFAXAN investment, citing strong NBRx growth, a large untreated patient population, and the impact of new commercial initiatives. He attributed the TRx/NBRx divergence to a market shift toward non-retail channels and growth in extended units.

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Dr. Leigh Peterson, VP of Product Development, responded that while competitor data is noted, the TETON trial is 80% powered to detect an 80-milliliter change in FVC. She stated the company fully anticipates achieving a clinically meaningful effect greater than that threshold and that the blinded results will be available in September.

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President and CEO Richard Francis explained that AUSTEDO's revenue dynamics are playing out as expected, with some Q2 2024 stocking affecting comparisons, but declined to detail IRA pricing. EVP & CFO Eli Kalif asserted that Teva has almost no reliance on China for materials, having divested its API business there years ago, which strengthens its supply chain.

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Marcus Yountz, VP of Clinical Development, stated that analyses are ongoing but the company does not believe there is a meaningful difference between QD and BID dosing. He also confirmed full confidence in the 8mg toxicology profile, which is being factored into Phase 3 dose selection.

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COO Blair Jackson confirmed that with U.S. manufacturing and minimal API imports, tariffs are not a material risk, and transfer pricing reform would likely require complex legislation. CEO Richard Pops added that all Phase II patients undergo visual exams and the DSMB, which includes an ophthalmologist, has cleared the study to proceed without changes.

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CCO Todd Nichols responded that while the treatment algorithm for LAIs hasn't changed (typically later-line use), the market is seeing lower overall growth, which he attributed partly to seasonality and lower schizophrenia patient visits. He noted that new brand launches are primarily causing shifts within the market rather than expanding it. He also acknowledged payer pressure from the Part D redesign is a topic of ongoing discussion.

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EVP & CMO Amy Peterson declined to share specific enrollment details. CEO Michael Morrissey did not provide a patient number for adjuvant CRC but stated the commercial opportunity for the new adjuvant CRC and meningioma studies is approximately three times greater than the discontinued head and neck trial, justifying the strategic pivot.

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President and CEO Michael Morrissey reiterated that the focus should be on the pivotal trials and their specific comparators, which are contemporary standards of care. He stressed that the RCC treatment landscape will evolve by 2030 and that Exelixis is planning its trials to define future standards of care, rather than focusing on simple comparisons between zanzalintinib and cabozantinib.

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CFO William Peters reiterated that the forecast relies on sales from two of three potential new product launches. Executive Tony Marrs clarified that FDA response times could be 90 days for a minor issue or 8-10 months for a major one. Peters explained last year's Q1 BAQSIMI sales were inflated by channel loading during the Lilly transition and that recent weekly data shows a return to strong growth. He noted that while glucagon will see more price pressure, this should be offset by growth in higher-margin products like Primatene MIST and BAQSIMI, along with internal cost-saving measures.

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William Peters, CFO and Executive Vice President of Finance, responded by forecasting high single-digit sales growth for Primatene Mist. For BAQSIMI, he noted a recent 3% U.S. price increase and anticipated high single-digit unit growth. Conversely, he projected that glucagon would experience declines in both pricing and unit volume due to mounting competitive pressures.

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Bruce Cozadd, Chairman and CEO, confirmed that Jazz Pharmaceuticals has a U.S. supplier for oxybate products, including Xywav, with sufficient capacity to meet all U.S. demand. He stated this would be a very effective option to mitigate tariff exposure and noted no particular issues regarding API sourcing being subject to tariffs.

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Bruce Cozadd, Chairman and CEO, reminded that the post-GW period was focused on deleveraging and highlighted the zanidatamab deal as a key strategic transaction. Philip Johnson, CFO, added that net leverage is now down to 1.8x, providing significant financial capacity for M&A. He stated that the extended Epidiolex runway makes the epilepsy franchise an even more attractive area for further investment.

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CEO Bruce Cozadd noted the company focused on deleveraging post-GW and highlighted the zanidatamab deal as a significant transaction. CFO Phil Johnson added that leverage is now down to 1.8x, providing significant capacity for M&A. He stated the Epidiolex longevity makes the epilepsy franchise an even more attractive area for investment.

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EVP, Global Head of R&D, Rob Iannone, explained that the positive Phase III results are expected to be sufficient for a standalone label expansion into first-line maintenance. He noted this could also serve as a confirmatory trial for the second-line accelerated approval. The commercial opportunity is significant, targeting a larger patient pool of approximately 27,000 extensive-stage patients annually with a potentially longer duration of therapy.

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EVP, Global Head of R&D Robert Iannone stated that the positive Phase III data alone are expected to support a first-line label expansion and could potentially serve as confirmatory for the second-line approval, depending on timing. He confirmed the first-line setting represents a larger patient population and likely a longer duration of therapy, expanding the overall opportunity.

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CEO Grant Pickering stated that the VAX-24 data, especially from the mixed-dose cohort, will be a key indicator for the VAX-31 infant program, and confirmed they can tweak individual serotype doses for Phase III. On policy, Pickering and Executive Andrew Guggenhime asserted that changing the PCV schedule is highly unlikely given the clear public health need and the complex, multi-stakeholder system (ACIP, AAP) that relies on scientific evidence to set recommendations.

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Executive Kyle Jenne, while noting the questions were best for partner Novartis, stated that an indication for the >90 mg/dL subgroup would still represent a 'massive' patient population. He confirmed that Novartis's confidence in the 2025 readout timeline is based on regular monitoring of blinded event rates in the ongoing study.

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The company explained that the Q4 revenue dip was due to the timing of patient infusions, with several patients collected in late 2023 scheduled for infusion in Q1 2024. They expect a linear build in patient starts for LYFGENIA throughout 2024, with the majority occurring in the second half of the year. They also noted that Q1 2024 has seen the strongest quarter for patient starts to date.

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The company clarified that over 80 patients are enrolled, with about 50 meeting the new criteria, and they are targeting 600 new patients. A decision on a Phase III interim analysis is pending, but it wouldn't yield public data. Key financing catalysts are the upcoming data from the 007 and 002 studies in 2024 and 2025.

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CEO Lan Huang explained that the DUBLIN-3 protocol was updated during the trial to include and stratify for PD-1/PD-L1 failed patients as the treatment landscape evolved. She asserted the primary endpoint was always overall survival analyzed by the log-rank P-value, which was never changed, and that the final p-value met the required statistical significance after accounting for two interim analyses. For full transparency, both median OS and restricted mean survival time will be presented at ESMO.

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Dr. Lan Huang, Co-Founder, Chairwoman and CEO, expressed confidence in avoiding an AdCom, citing a successful FDA inspection with no 483s and a positive orientation meeting with the agency. She also highlighted data correlating plinabulin's endpoints with clinical outcomes. Dr. Ramon Mohanlal, EVP of R&D and CMO, confirmed that moving the combination into first-line NSCLC is part of the plan, noting plinabulin's unique potential to increase survival while preventing both neutropenia from chemo and immune-related events from I/O agents.

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Richard Daly, COO, explained that the company is preparing for launch but will be judicious, likely hiring sales reps upon approval to manage costs, and suggested a 2022 launch might be more effective than a late Q4 launch. Dr. Lan Huang, CEO, stated that while ORR and PFS data from DUBLIN-3 are important for comparison, the decision to release them depends on the data quality. Dr. Ramon Mohanlal, CMO, and Dr. Huang elaborated that the small cell lung cancer trial aims to show that plinabulin can enhance survival and reduce immune-related adverse effects in combination with checkpoint inhibitors, including in patients who have already failed such therapies.

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President and CEO Maria Palasis explained that the primary agenda item for the FDA meeting is the primary endpoint, for which they will propose a composite of cardinal symptoms at a later time point up to 24 weeks. She added that discussions will also cover key secondary endpoints, such as rescue treatments, and a planned study size of approximately 350 patients using the 7,500 microgram dose to ensure statistical power.

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