Yigal Nochomovitz • Citigroup

Answer

CEO Kenneth Galbraith confirmed that partners Jazz and B1 are managing the zanidatumab supply chain and are prepared for domestic manufacturing if needed. He and CSO Paul Moore added that Zymeworks has deep roots in computational biology and actively uses AI and machine learning in protein engineering and the design of complex biologics like multi-specific antibodies.

Ask Fintool Equity Research AI

Answer

Chief Scientific Officer Dr. Paul Moore explained that they have not conducted direct head-to-head comparisons with ADCs, as they typically benchmark against similar modalities. He stated that the T-cell engager approach was chosen for DLL3 due to the clinical proof-of-concept from tarlatamab and the opportunity to leverage Zymeworks' proprietary co-stimulatory (TriTCE) platform, which preclinical data strongly supported for this target.

Ask Fintool Equity Research AI

Answer

Chair and CEO Kenneth Galbraith reiterated the decision was about accelerating a high-potential program. CSO Dr. Paul Moore added that maturing preclinical data from HCC PDX models continued to look very exciting, supporting the decision. Galbraith stated that no guidance has been given on the timing or method for reinitiating the IND-ready ZW220 program.

Ask Fintool Equity Research AI

Answer

CEO Kenneth Galbraith stated that data will be shared at peer-reviewed medical meetings only after a substantial and conclusive dataset is available, not via preliminary press releases. Regarding the share repurchase, he confirmed the first $30 million tranche is complete and the decision to initiate the second tranche will depend on a careful evaluation of market conditions, though he reiterated the company still feels undervalued.

Ask Fintool Equity Research AI

Answer

Rafael Amado, President and Head of Global R&D, stated he could not comment on the specific OS delta for bemarituzumab due to data embargo but reiterated the results were clinically meaningful. For the DLL3 ADC, he expressed confidence that the 1.6 mg/kg dose would be combinable with atezolizumab due to non-overlapping toxicities. Josh Smiley, President & COO, addressed efgartigimod's potential, noting that new indications could expand the addressable patient population in China from ~170,000 to over 500,000, reinforcing the company's view of a greater than $1 billion peak sales opportunity.

Ask Fintool Equity Research AI

Answer

Jonathan Wang, CBO, explained that VYVGART's IV and subcutaneous formulations are treated as separate products, allowing pricing flexibility, and expects a 'modest discount.' Dr. Rafael Amado, President and Head of Global R&D, highlighted bemarituzumab's targeted approach for the distinct FGFR2b patient population and confirmed the ADCs feature a linker system allowing for both intracellular and extracellular payload release.

Ask Fintool Equity Research AI

Answer

Dr. Rafael Amado, President and Head of Global R&D, detailed that the upcoming data presentation will include about 75 patients from dose escalation and optimization cohorts. For the first-line setting, the strategy involves combination studies with PD-L1 inhibitors and chemotherapy, with the goal of potentially supplanting the current standard of care. Data from this first-line dose optimization is expected later in the year.

Ask Fintool Equity Research AI

Answer

President and COO Josh Smiley stated that patients are not waiting for the subcu version for GMG, as the IV formulation is suitable for the current hospital-based treatment setting. Dr. Harald Reinhart, President and Head of Global Development, added that for CIDP, there are no approved treatments, creating a significant unmet need where VYVGART can have a major impact.

Ask Fintool Equity Research AI

Answer

Dr. Jula Inrig, Chief Medical Officer and a co-author of the cited paper, explained that while the paper didn't define a specific duration, 85% of DUPLEX patients who achieved CR stayed below their baseline proteinuria, showing durability. President & CEO Dr. Eric Dube added that the Parasol analysis, which is more recent and robust, is the key focus and that the treatment effect in DUPLEX was sustained at both nine months and two years.

Ask Fintool Equity Research AI

Answer

CEO Eric Dube confirmed that any REMS in place at the time of a potential FSGS approval would apply to the new indication, and that the next step after modification is full removal. CCO Peter Heerma addressed pricing, stating that while the dose is doubled, the pricing strategy is based on the value proposition, which is higher in the more progressive FSGS. He noted they are refreshing their value assessment and did not commit to a specific price.

Ask Fintool Equity Research AI

Answer

CEO John Houston, CMO Noah Berkowitz, and CSO Angela Cacace all contributed. They confirmed AI is used through vendors for NDA submissions and more broadly in development for medical writing, clinical operations contract management, and statistical programming. In research, AI and machine learning are heavily used for PROTAC design optimization, identifying new drug targets, and mining biomarker data from public datasets to inform clinical strategy for diseases like Parkinson's.

Ask Fintool Equity Research AI

Answer

CEO John Houston and CMO Noah Berkowitz clarified the KAT6 combo rationale is based on Pfizer's data and attractive results with fulvestrant, not specific Arvinas preclinical work. Houston confirmed Pfizer manages manufacturing in Ireland while Arvinas holds the IP in the U.S. He also acknowledged that the challenges of a novel-novel combination likely factored into Pfizer's decision to await more mature data.

Ask Fintool Equity Research AI

Answer

CMO Noah Berkowitz indicated the comparator would likely be an AI combination, but the final design is not set. CEO John Houston addressed the DDI concern, stating that upcoming data will demonstrate that vepdegestrant is broadly combinable and that any potential interaction is a 'non-issue from a clinical perspective.'

Ask Fintool Equity Research AI

Answer

CEO Jay Duker explained that the blended endpoint was a 'strong suggestion' from the FDA that the company adopted to decrease variability and de-risk the trial. He noted this approach is not new and has been used in other recent studies. Regarding a potential launch, Duker stated that EyePoint is 'working diligently towards an immediate launch after approval,' assuming successful trial outcomes and a positive NDA review.

Ask Fintool Equity Research AI

Answer

President and CEO Dr. Jay Duker expressed high confidence in being first-to-file, citing rapid enrollment, a 56-week trial duration, and no run-in period before randomization. He detailed the supply chain, noting the API is U.S.-sourced and the inserts are manufactured in-house in Massachusetts at a facility capable of meeting global demand. This vertical integration and the small molecule nature of vorolanib provide a secure and cost-effective supply chain, mitigating tariff risks.

Ask Fintool Equity Research AI

Answer

President and CEO Dr. Jay Duker attributed the difference in dose performance to a clear dose-response, emphasizing the strength of the 2.7mg go-to-market dose. He also indicated that EyePoint expects to provide more granular timing on the Phase III data readout in the second half of 2025.

Ask Fintool Equity Research AI

Answer

Eric Crombez, Chief Medical Officer, explained that the GSD1a filing is being carefully managed because both it and UX-111 are produced at the same manufacturing facility, so any facility-related findings could have implications for both. He also noted that for OI, the Phase III ORBIT study enrolled a higher proportion of severe Type 3 and 4 patients compared to Phase II, which influences baseline characteristics.

Ask Fintool Equity Research AI

Answer

CEO Emil Kakkis explained that following strong Phase II results, physicians enrolled more severe Type 3 and 4 patients into the Phase III study, resulting in about half the population being Type 3 or 4. On the p-value, he confirmed that a result like 0.015 would not meet the <0.01 threshold and would be considered a miss. He also reiterated that the company was not provided the p-value from the first interim analysis.

Ask Fintool Equity Research AI

Answer

CEO Emil Kakkis was non-committal about releasing past interim data, emphasizing that the final result is what matters. He pointed to the Phase II data, where the p-value improved from 0.04 at 6 months to 0.0014 at 14 months, as a reasonable model for the expected progression in the Phase III study.

Ask Fintool Equity Research AI

Answer

CEO Emil Kakkis explained the original group had a 41% reduction in the blinded phase and is now improving further. CFO Howard Horn reiterated the path to profitability, stating that with recent financing and expected PRV monetizations, the company has the cash to fund its plan to reach a GAAP profitable quarter by the end of 2026, driven by revenue growth and leveling expenses.

Ask Fintool Equity Research AI

Answer

CEO Michael Metzger confirmed that the remaining two-thirds of transplant patients are expected to restart maintenance over time. CCO Steve Closter described the reimbursement process as 'seamless,' with no challenges expected. CMO Dr. Nick Botwood added that the company is collaborating with leading cancer centers to present real-world data on patient outcomes later in the year.

Ask Fintool Equity Research AI

Answer

CEO Michael Metzger explained that separate trials for the fit population are more efficient as they allow for trial designs optimized for the different characteristics and treatment goals of each patient group. Regarding transplant timing, he clarified that Syndax is not privy to the specific remission status of individual patients, as that is a physician's clinical decision.

Ask Fintool Equity Research AI

Answer

CCO Steven Closter declined to confirm specific patient counts, citing limited visibility, but defined Tier 1/2 centers as the top ~200 accounts representing two-thirds of the patient opportunity. President and Head of R&D Dr. Neil Gallagher stated that while they are aggressively planning multiple trials in the fit setting, they are not disclosing specific trial designs due to the competitive landscape.

Ask Fintool Equity Research AI

Answer

Chairman & CEO Krish Krishnan stated the company is targeting the full 1,200 identified patient base, calling the 720 number a benchmark for launch speed. SVP & GM for Europe Laurent Goux explained the EAP comment relates to a formal transition from a pre- to post-authorization access program, in which they are confident.

Ask Fintool Equity Research AI

Answer

Krish Krishnan, Chairman and CEO, described Japan as an attractive market with a prevalence of around 500 patients, over 200 of whom are identified. He expects pricing between U.S. and EU levels and a launch in late 2025 or early 2026. Both Krish and Suma Krishnan, President of R&D, confirmed the pre-approval manufacturing inspection for Japan was completed successfully with no findings.

Ask Fintool Equity Research AI

Answer

CEO Krish Krishnan and President of R&D Suma Krishnan clarified that the goal is to confirm prior findings and establish a dose response. They explained that while AAT levels in the lung are the primary focus, establishing a clear correlation with plasma levels could provide a less invasive biomarker pathway for regulatory purposes, potentially avoiding the need for future bronchoscopies.

Ask Fintool Equity Research AI

Answer

Christine Wilson, SVP and Head of U.S. Sales and Marketing, confirmed that social media outreach is successfully engaging patients not previously connected to the healthcare system. Chairman and CEO Krish Krishnan added that the trend of market expansion continues as awareness grows, and the company will report on significant milestones as they are achieved.

Ask Fintool Equity Research AI

Answer

CEO Dr. Cedric Francois confirmed the FSGS trial would align with the Parasol group's work. EVP of Commercial, David Acheson, clarified that 'free goods' is a new, more inclusive term that encompasses both traditional samples and the patient assistance program (PATH) to capture all non-commercial product.

Ask Fintool Equity Research AI

Answer

Executive David Acheson stated there is no predictability on the co-pay issue, and the company is operating as if it will not be resolved. For the EMPAVELI launch, he detailed that field teams are actively profiling accounts, medical affairs is educating on the data, and the key message is that EMPAVELI's superior efficacy will drive physician choice over route of administration. The teams have been in the field since April, preparing for a launch post-PDUFA date.

Ask Fintool Equity Research AI

Answer

CEO Dr. Cedric Francois explained the combo trial will synchronize subcutaneous and intravitreal injections for physician convenience. CFO Tim Sullivan addressed the patent question, stating that composition of matter for EMPAVELI extends to roughly 2035 with extensions, providing a significant runway for the new indications.

Ask Fintool Equity Research AI

Answer

CFO Timothy Sullivan explained the Q3 gross-to-net increase was a 'perfect storm' resulting from three factors: strategic contracting decisions from late 2023, new rebates in Q3, and a true-up of prior quarter fees. COO Adam Townsend added that patient persistence and discontinuation rates are tracking similarly to established anti-VEGF therapies, supported by strong patient motivation and the flexibility of every-other-month dosing.

Ask Fintool Equity Research AI

Answer

Executive Dave Gancarz explained that top-line data would be more qualitative, with detailed geographic breakdowns likely presented in a forest plot at a major medical conference. He and Chief Medical Officer Dr. Allen Yang emphasized that HARMONi has two primary endpoints (PFS and OS) and the total data package will be considered for filing, noting that statistically significant OS has not been a precedent for approval in this specific setting. Regarding ADC strategy, Dr. Yang stated the company is open to other collaborations, and Dr. Jack West added that other combinations are being explored through ISTs and cooperative groups.

Ask Fintool Equity Research AI

Answer

Executive Dave Gancarz explained that top-line data would be qualitative, with detailed geographic breakdowns at a major medical conference. He and Chief Medical Officer Dr. Allen Yang emphasized that while OS is a primary endpoint, the totality of the data package is key, and precedent in this setting doesn't require stat-sig OS for approval. Dr. Yang and Dr. H. Jack West, VP, confirmed they are open to other ADC collaborations and are exploring combinations via ISTs.

Ask Fintool Equity Research AI

Answer

Dave Gancarz, an executive, stated that the required events for the HARMONi-2 interim analysis are anticipated by the end of 2025. Dr. Allen Yang, Chief Medical Officer, explained that while statistically significant OS is the goal for the HARMONi trial, historical precedent suggests that progression-free survival (PFS) alone could be sufficient for approval. Manmeet Soni, COO & CFO, noted it was too early to provide a timeline for HARMONi-3's completion but confirmed the HARMONi-6 trial should read out in mid-to-late 2025. Dave Gancarz added that the Pfizer collaboration involves multiple ADCs in Phase Ib/II studies for solid tumors, with trials expected to start mid-2025.

Ask Fintool Equity Research AI

Answer

CFO Manmeet Soni explained that amending the existing trial was faster and more efficient, leveraging existing sites and avoiding long lead times for a new study. CMO Dr. Allen Yang added that physicians were excited by the change. Regarding HARMONi-2's OS potential, Dr. Yang expressed unchanged confidence, citing the strong PFS hazard ratio and historical precedents where similar PFS benefits translated to OS benefits, noting the primary endpoint was PFS.

Ask Fintool Equity Research AI

Answer

Chief Medical Officer Dr. Allen Yang expressed increased confidence in HARMONi-3 following the HARMONi-2 results, confirming it will enroll patients with all TPS scores. He could not disclose timelines for HARMONi-3 interim readouts. Chairman and CEO Robert Duggan explained that the MD Anderson collaboration will complement Akeso's Phase II work by exploring tumor types less prevalent in China and providing access to key scientific expertise.

Ask Fintool Equity Research AI

Answer

CFO Aaron Rosenberg stated it was too early to discuss specific pricing but that it would reflect the value created for patients. On supply chain, he confirmed the company is proactively ensuring global supply resilience. CEO John Oyler described the company's geographic footprint as being in 'inevitable expansion mode' globally, including active R&D recruitment in the U.S.

Ask Fintool Equity Research AI

Answer

CFO Aaron Rosenberg stated it was too early to discuss pricing but expressed confidence in the value the assets create. On supply chain, he affirmed the company is monitoring the environment and will act proactively to ensure supply. CEO John Oyler addressed the R&D question, describing the company as being in a constant state of global expansion, including recruiting for R&D in their San Carlos, California office, as part of a natural process to work globally.

Ask Fintool Equity Research AI

Answer

CFO Aaron Rosenberg confirmed the 2037 patent timeline as a starting point and emphasized that the broader strategy is to build a long-lived, durable franchise. He explained that combinations with assets like sonrotoclax, which have their own patent life, will extend protection well beyond BRUKINSA's exclusivity.

Ask Fintool Equity Research AI

Answer

President Juan Jaen stated it was too early to give specific guidance on PEAK 1 timing but noted the PFS endpoint and expected rapid enrollment could narrow the gap with Merck's trial, which was pushed to 2027. CEO Terry Rosen added that Arcus plans to execute the PEAK 1 trial on its own, citing a strong capital position, an experienced team, and significant investigator enthusiasm, though he did not rule out opportunistic collaborations.

Ask Fintool Equity Research AI

Answer

CEO Terry Rosen clarified that with multiple cohorts from ARC-20 maturing, the company felt it was important to be transparent and would look for opportunities to release meaningful data as it emerges. However, he stated there are no specific plans for an update at this moment.

Ask Fintool Equity Research AI

Answer

CMO Dimitry Nuyten explained the expansion cohort is primarily for establishing safety data before the larger Phase III trial, noting minimal expected overlapping toxicities. COO Jennifer Jarrett confirmed that the 50mg cohort showed a lower primary progressive disease rate than the LITESPARK-005 benchmark and that data would be presented separately. CEO Terry Rosen and COO Jennifer Jarrett added that the first-line combination partner will be disclosed soon, will be a differentiated approach from Merck, and involves a collaboration partner.

Ask Fintool Equity Research AI

Answer

CEO Terry Rosen noted the firm 7-8 month PFS benchmark for standard of care and expressed confidence that the upcoming data will be meaningful, despite a patient population with lower PD-L1 expression than in the CheckMate 649 study. COO Jennifer Jarrett added that in CheckMate 649, the PFS and OS benefits were highly correlative. Rosen explained that Cohort A2 enrolled sequentially and is about a year behind Cohort A1, but will provide another look at zimberelimab plus chemo versus historical controls.

Ask Fintool Equity Research AI

Answer

President and CEO Michael Raab explained the IBSRELA guidance reflects typical Q1 market contraction and the company's practice of providing achievable targets. He confirmed the XPHOZAH peak sales timeline includes the Hatch-Waxman extension and stated that any potential business development deal is to be determined based on finding the right opportunity.

Ask Fintool Equity Research AI