Matthew Phipps

Matt Phipps inquired about details regarding the auto-injector, its positioning relative to the prefilled syringe (PFS), and its potential to drive continued expansion across indications.

Answer

Karen Massey, Chief Operating Officer, stated that the auto-injector is on track for 2027. She clarified that it will not provide the same step-change acceleration as the PFS, which enabled patient self-injection. Instead, the auto-injector offers a better experience for patients, particularly those with needle phobia, providing value but not acting as a significant growth accelerator.

Matt Phipps asked for more details on the auto-injector, its positioning relative to the prefilled syringe (PFS), and its potential to drive continued expansion across indications.

Answer

Karen Massey, COO, stated the auto-injector is on track for 2027. She explained that while it won't provide the same step-change as the PFS (which enabled self-injection), it offers a better experience for patients, particularly those with needle phobia, reinforcing argenx's innovation playbook.

Matthew Phipps asked for clarification on the myositis Phase III trial design, specifically whether a set number of patients are being enrolled for each of the three subsets to power them individually.

Answer

CEO Tim Van Hauwermeiren confirmed the analyst's assumption was correct, stating they will need a 'minimum representation of every subset' in the registrational trial to generate data-based conclusions for discussions with the FDA.

Matthew Phipps asked if CIDP patients were included in the human factors study for the prefilled syringe (PFS) and whether Argenx plans to offer a free drug program for CIDP during the initial payer coverage gap.

Answer

CEO Tim Van Hauwermeiren confirmed that both gMG and CIDP patients were actively involved in the human factors studies for the PFS. Regarding launch support, COO Karen Massey stated that while not providing specifics, the approach to the CIDP launch will be innovative and disciplined, similar to the successful gMG launch, to ensure patient access.

Matt Phipps inquired if there is any correlation with eosinophil levels in the work examining COPD and bronchiectasis overlap, and whether biologics targeting type 2 inflammation might become an intermediate step for physicians before ordering a CT scan for their patients.

Answer

Martina Flammer, Chief Medical Officer, explained that physicians follow treatment escalation paradigms for COPD and asthma. If patients are optimally treated, even with biologics, but continue to exacerbate, physicians should develop a clinical suspicion for 'something else' and consider a CT scan to investigate for bronchiectasis, as the underlying disease may not be the sole driver of exacerbations.

Matthew Phipps asked about the dose preference for Brensupri prescriptions (25mg vs. 10mg) and whether the 25mg's potential lung function benefit is resonating with physicians.

Answer

Roger Adsett, Chief Operating Officer, stated that the majority of prescriptions are for 25mg, but some physicians are starting with 10mg. He confirmed that the lung function benefit is resonating, particularly with thought leaders, and noted that some physicians may start low and increase the dose as they gain experience.

Matthew Phipps asked about the preferred dose for BRINSUPRI prescriptions (10mg or 25mg) and if the 25mg's potential lung function benefit is resonating with physicians.

Answer

Roger Adsett, Chief Operating Officer, stated that the majority of prescriptions are for the 25mg dose, but some physicians are choosing to start with 10mg. He confirmed that the lung function benefit is resonating, particularly with thought leaders, and some physicians may increase the dose as they gain experience.

Matthew Phipps asked for confirmation on an additional Phase 3 trial for petosemtamab in 2026, specifically if it's the locally advanced trial previously discussed, and whether there would be an update on the colorectal cancer cohorts seen in the fall, along with thoughts on the development plan.

Answer

Chief Development Officer Judith Klimovsky confirmed that the colorectal data presented in December was encouraging, despite a limited number of patients, and the data set is growing. She stated that as the data grows, they plan to inform the medical community, though a specific timeline has not been decided. Klimovsky also confirmed that future Phase 3 trials include the locally advanced head and neck study, and they are actively working on a comprehensive clinical development plan.

Matthew Phipps asked for confirmation on an additional Phase III for petosemtamab in 2026 (specifically if it's the locally advanced trial or something else) and requested an update on the colorectal cancer cohorts and development plan.

Answer

CEO Jan van de Winkel and Chief Development Officer Judith Klimovsky responded. Klimovsky confirmed the locally advanced head and neck trial as a future Phase III and stated that Genmab is actively working on a comprehensive clinical development plan. Regarding colorectal cancer, she noted the encouraging but limited data presented in December, with cohorts still growing (40, 40, and 60 patients). Genmab plans to inform the medical community as the data matures.

Matt Phipps of William Blair inquired about Genmab's strategy for combining Epkinley with ADCs in lymphoma and asked if the Akasunlimab melanoma trial would use the same every-six-week dosing regimen.

Answer

Chief Medical Officer Tahamtan Ahmadi confirmed that ADC combinations are an interesting part of the development strategy, with an investigator-sponsored trial planned. CEO Jan van de Winkel and Chief Development Officer Judith Klimovsky affirmed that Akasunlimab will use the every-six-week dosing, as it has shown optimal efficacy and safety.

Matt Phipps of William Blair asked about the development plan for epcoritamab, specifically regarding combinations with ADCs in lymphoma, and whether the acasunlimab trial in melanoma would use the same every-six-week dosing regimen.

Answer

Tahamtan Ahmadi, EVP & CMO, said ADC combinations are part of a strategy to generate complementary data, noting a planned investigator-sponsored trial with Polivy and the ambition for Epkinley to be a backbone therapy. CEO Jan van de Winkel confirmed that acasunlimab will use the every-six-week dosing, which is considered optimal, a point echoed by Judith Klimovsky, EVP & CDO.

Matthew Phipps of William Blair inquired if Genmab is considering using the FDA's Project FrontRunner pathway for other studies beyond the current second-line follicular lymphoma trial.

Answer

CMO Tahamtan Ahmadi explained that pursuing novel regulatory pathways like Project FrontRunner is most effective with compelling data. He confirmed Genmab will continue to explore such opportunities to accelerate patient access for other programs if the supporting data is profound and meaningful.

Matthew Phipps from William Blair asked if the FDA's new biosimilar guidance, potentially removing the need for comparative efficacy studies, changes Amgen's strategic view on the biosimilar business, including barriers to entry and the calculus for pursuing specific biologics.

Answer

Murdo Gordon, EVP of Global Commercial Operations, stated that the new guidance does not change Amgen's strategic focus on biosimilars, as they remain a strong growth business. Robert Bradway, CEO, added that Amgen believes the U.S. biosimilar market is performing well and advocates for policies that support its continued flourishing, distinct from the generic drug industry.

Matthew Phipps questioned how the FDA's recent new biosimilar guidance, potentially removing the need for comparative efficacy studies, might alter Amgen's strategic view on the biosimilar business, including barriers to entry and the calculus for pursuing new biosimilars.

Answer

Murdo Gordon, EVP of Global Commercial Operations, stated that the new guidance does not change Amgen's strategic focus on biosimilars, which remains a strong growth business. He affirmed Amgen's technical and regulatory teams are prepared to adapt to new requirements, regardless of the emphasis on clinical trials or technical comparability. Robert Bradway, CEO, added that the U.S. biosimilar market is performing well, advocating for policies that support its continued flourishing and cautioning against changes that might push it towards the generic drug industry model.

Matt Phipps asked about the newly disclosed AMG 732 program for thyroid eye disease (TED), inquiring how it differentiates from TEPEZZA and what unmet need it aims to address.

Answer

James Bradner, EVP of R&D, described AMG 732 as a next-generation, subcutaneously administered antibody targeting IGF-1R. Robert Bradway, Chairman & CEO, framed it as an example of Amgen's strategy to bring further innovation to the acquired Horizon portfolio.

Matthew Phipps from William Blair inquired about the market opportunity for TEZSPIRE in chronic rhinosinusitis with nasal polyps (CRSwNP), asking about the degree of patient overlap with severe asthma and the potential for biologics to shift the treatment paradigm away from surgery.

Answer

Murdo Gordon, EVP of Global Commercial Operations, confirmed a significant opportunity with 1-2 million U.S. patients and a roughly 40% overlap with severe asthma. He stressed that TEZSPIRE's clinical trial data showed it could 'reduce almost entirely the need for surgery,' indicating a strong potential to move ahead of surgical intervention and improve patient quality of life.

Matthew Phipps asked for specific details on the planned TEZSPIRE COPD trials, including whether the 420mg dose would be used, if it could be formulated as a single injection, and if the two Phase III trials would have identical designs.

Answer

EVP of R&D James Bradner stated that he could not address those specific questions at this time. He indicated that the full design of the Phase III program would be described in the future in collaboration with partner AstraZeneca.

Matt Phipps inquired about the design of future studies for bretisilocin (from Gilgamesh), particularly regarding low-dose active control, and its fit into the major depressive disorder treatment paradigm given in-clinic administration.

Answer

Roopal Thakkar, Executive Vice President, Research and Development, Chief Scientific Officer, expressed excitement for bretisilocin due to its short hallucination duration and potential for long-lasting effects after few doses. He discussed plans for phase II and III studies, including a low-dose comparator, and potential expansion into other mood disorders.

Matt Phipps asked for details on how AbbVie plans to design future studies for bredacillicin following the Gilgamesh acquisition, particularly regarding low-dose active controls, and its fit into the major depressive disorder (MDD) treatment paradigm.

Answer

EVP, Research and Development, and CSO Roopal Thakkar expressed excitement for bredacillicin's short hallucination duration and long-lasting effects, noting plans for Phase 2 and 3 studies to explore different doses and durations. He confirmed the regulatory need for a low-dose comparator, which was successfully used in Gilgamesh's prior Phase 2 study.

Eric, on behalf of Matt Phipps from William Blair, asked for updated thoughts on the development plan for graft-versus-host disease, specifically seeking clarity on the focus between a prophylactic setting versus treating acute steroid-refractory patients.

Answer

Dr. Jennifer Buell, President and CEO, clarified that the currently funded and advancing program is focused on the prophylactic setting. She detailed that patients will be dosed post-engraftment to assess engraftment success, infection reduction, and GVHD mitigation, confirming the trial is designed for prevention rather than treating active GVHD.

Matthew Phipps of William Blair asked for specific details about the planned graft-versus-host disease (GvHD) trial, including whether it would target acute patients and what the enrollment criteria or prior treatments might be.

Answer

President and CEO Dr. Jennifer Buell clarified that the company has developed two Phase I programs: one for steroid-refractory acute GvHD and another for prophylaxis to improve engraftment success. The path chosen will depend on financing, including a potential grant and a separate proposal from a strategic collaborator. Executive Thiago Favano added that the Phase I trial will also assess other transplant complications, such as infections and disease relapse, to demonstrate the broader potential of iNKT therapy.

Matt Phipps of William Blair asked about the revenue recognition process if a patient receives only the first of two Ocatsol infusions. He also inquired about the potential timeline for Autolus to achieve gross profit positivity.

Answer

CEO Christian Itin stated that if only the first infusion is administered, which is exceedingly rare, only that portion of the revenue is recognized. CFO Rob Dolski added that achieving positive gross margin is a "volume story" and expects continued improvement in the second half of the year as volumes increase, though he provided no specific timeline for flipping to profitability.

Matthew Phipps of William Blair inquired about the composition of the Q1 Cost of Goods Sold (COGS), specifically the impact of canceled orders or patient access programs, and asked if the observed longer persistence of obe-cel in autoimmune disease is a key differentiator.

Answer

CFO Rob Dolski explained that COGS primarily consists of the cost of manufactured product (both sold and deferred), royalties, and idle capacity charges, with smaller impacts from patient assistance or cancellations. He disclosed that deferred revenue was approximately $4.7 million. CEO Christian Itin added that obe-cel's longer persistence is a positive attribute, believing it is crucial for achieving a deep and consistent B-cell depletion necessary for a therapeutic reset.

Matthew Phipps of William Blair & Company asked for commentary on the manufacturing success rate and turnaround times during the commercial launch. He also inquired if BioNTech has made a decision on its option for the AUTO6NG program and the timeline for such a decision.

Answer

Executive Christian Itin confirmed that the commercial manufacturing experience is 'mirroring very nicely' the results from the pivotal study, which is reassuring. Regarding the BioNTech option on AUTO6NG, he stated the option is still active and would be triggered prior to the program moving into a pivotal study, indicating a decision is 'still a little bit ahead of us.'

Matthew Phipps asked about the general timelines for initiating trials in additional autoimmune indications, such as progressive MS, and inquired whether patient identification or center capacity is the biggest gating factor for the ongoing SLE trial.

Answer

CEO Christian Itin stated that the company is actively advancing its autoimmune activities and expects to provide an update on new trials during the first quarter of the next year. He clarified that for the current SLE trial, center capacity is not an issue, and enrollment rates have picked up well after a typical summer slowdown.

Matt Phipps of William Blair & Company inquired about the upcoming data for Dynavax's shingles vaccine program, focusing on the key success metrics like CD4 T-cell response compared to Shingrix, the time points for these measurements, and the expected detail on the side effect profile.

Answer

Chief Medical Officer Robert Janssen explained that the initial one-month data will focus on the vaccine response rate (VRR), a composite of CD4 and antibody response, due to potential variability in small subject groups. He added that CD4 levels would be tracked over time. CEO Ryan Spencer reiterated that while the trial is not powered for statistical comparisons of reactogenicity, they expect the tolerability data to be supportive of a favorable profile.

Matthew Phipps inquired why Dynavax did not officially raise its full-year guidance despite expressing confidence in achieving the upper half. He also asked for clarification on the company's capital allocation and business development strategy, particularly whether the announcement of two new preclinical programs (pandemic influenza and Lyme disease) signals a reduced appetite for near-term external acquisitions.

Answer

CEO Ryan Spencer explained that it was prudent to maintain the current guidance range as it is only the first quarter of the year. Regarding strategy, he reiterated the company's balanced approach to capital allocation, which includes advancing internal programs leveraging the CpG 1018 adjuvant, seeking high-value external assets to utilize its commercial infrastructure, and returning capital to shareholders via buybacks. Spencer affirmed that the company believes it has the capacity to pursue all these avenues simultaneously.

Matthew Phipps asked about the remaining barriers to HEPLISAV-B market share growth, the specific non-inferiority metrics for the shingles vaccine program, and the consistency of safety data collection methods across different shingles vaccine trials.

Answer

Chief Commercial Officer Donn Casale identified expanded Medicare access in retail and the new HEDIS measure as key drivers for future HEPLISAV-B market share gains. Regarding the shingles program, CEO Ryan Spencer and Chief Medical Officer Rob Janssen clarified that the company will assess a 'constellation' of immunogenicity data, not just a single marker, noting that the goal is to achieve around 75% of Shingrix's median T cell quantity. Dr. Janssen also stated that while data collection instruments aren't public, the FDA insists on fairly standard e-diaries for key safety events.

Matthew Phipps of Cantor Fitzgerald inquired about Dynavax's updated 2030 market outlook for HEPLISAV-B, asking if the previous 2027 forecast of an $800 million market remains intact. He also sought clarity on the growth drivers between 2027 and 2030, particularly the contribution from the retail channel, and questioned how the company plans to achieve its 60% total market share goal given current stable shares in target segments.

Answer

CEO Ryan Spencer confirmed the 2027 view is unchanged and the 2030 guidance is an extension of that forecast. Chief Commercial Officer Donn Casale elaborated that the retail pharmacy segment is expected to be the primary growth driver due to its established infrastructure and incentives for adult vaccination. Casale also explained that achieving the 60% total market share goal will be driven by disproportionate growth and continued share gains within the key retail and IDN segments, with some spillover into other areas.

Matthew Phipps questioned if the valuation of the Emeryville manufacturing facility has increased due to onshoring trends and asked for clarification on whether the potential BOT/BAL licensing agreements are global or geography-specific.

Answer

CEO Garo Armen acknowledged the Emeryville facility's value could increase but stated they are pursuing a sale now as an inexpensive way to access capital. He clarified that of the four proposals received, two are for global licensing deals that would include underwriting future trial costs, while two other potential deals being considered are geography-specific.

Matthew Phipps asked for an update on the timing of potential data releases from BOT/BAL cohorts in other tumor types, specifically melanoma and pancreatic cancer.

Answer

Dr. Garo Armen, Chairman and CEO, noted that data has been generated across approximately 10 tumors, with compelling results in sarcoma recently presented at ESMO. Dr. Steven O’Day, Chief Medical Officer, confirmed that Phase II trials in refractory pancreas and refractory melanoma have completed accrual, and the company expects to have randomized data from these maturing studies in 2025.

Matt Phipps inquired about povorcitinib in CSU, asking how its efficacy compares to MRGPRX2 inhibition and whether the positive data alters plans for developing backup X2 antagonist programs.

Answer

An Incyte executive stated that comparative efficacy data will be discussed when the povorcitinib CSU results are presented later in the year. They also confirmed that Incyte has no plans to restart the X2 antagonist program and will advance povorcitinib into pivotal studies for CSU based on the strong proof-of-concept data.

Matthew Phipps of William Blair & Company asked about the learnings from the prior robust trial that were applied to the current frontline strategy. He also inquired if the mutant-CALR program data this year would be monotherapy only or include a Jakafi combination, and about any preclinical differences in activity against type 1 vs. type 2 CALR mutations.

Answer

Pablo Cagnoni, President, Head of R&D, addressed the second question, stating that a Jakafi combination study for mutant-CALR has been initiated and it's possible some combo data will be disclosed. He confirmed the antibody has different affinity for type 1 vs. type 2 mutations, which could lead to different clinical activity. The question about the robust trial was not directly answered.

Matthew Phipps from William Blair & Company asked for the rationale behind adding a 25 mg arm to the INCB00262 trial in chronic spontaneous urticaria (CSU) and questioned how the drug's profile would compete against BTK inhibitors or more effective treatments.

Answer

An unnamed executive clarified that the 25 mg arm was added to explore the full dose range and expedite a potential move to Phase III. He positioned INCB00262 to fit perfectly after antihistamines, expecting a very clean safety profile and convenient oral dosing to be ideal for patients before they move to more aggressive therapies, differentiating it from treatments that deplete all mast cells.

Matthew Phipps asked about early adoption trends for the subcutaneous formulation of Opdivo, Qvantig, and also questioned the commercial significance of the upcoming Reblozyl data in myelofibrosis.

Answer

CCO Adam Lenkowsky reported that Qvantig adoption is progressing well, primarily in the community setting across multiple tumors, with a ramp expected in the second half after a permanent J-code is issued. He characterized the Reblozyl opportunity in myelofibrosis as 'pretty modest,' stating the brand's growth will continue to be driven by its core MDS indication.

Matthew Phipps of William Blair followed up on the iberdomide trial, asking about durability requirements for the MRD endpoint, and also questioned the profitability breakpoint for Abecma and if Arlocell's success could impact its necessity.

Answer

CMO Samit Hirawat explained that since MRD is a new registrational endpoint, durability will be a key discussion point with the FDA. CCO Adam Lenkowsky stated that BMS remains committed to optimizing Abecma's value in a competitive market and highlighted the GPRC5D CAR-T (Arlocell) as a critically important future option for post-BCMA patients.

Matthew Phipps inquired about the market opportunity for the GPRC5D CAR-T relative to Abecma, asking if it's positioned to challenge BCMA CAR-T or be used sequentially.

Answer

Head of Global Drug Development Samit Hirawat clarified that the GPRC5D CAR-T is viewed as an important asset to be used after a BCMA CAR-T treatment. He expressed confidence that its single-dose administration and toxicity profile create a great opportunity for it to become another leading cell therapy asset for the company.

Matt Phipps of William Blair sought clarification on the amended MISSION Phase 2 trial design, including the shift to a single-arm, open-label study using only the 60mg dose. He also asked about specific inclusion criteria, the definition of renal response, and plans to expand the trial's geographic footprint.

Answer

Chief Medical Officer Noreen Henig confirmed the MISSION Phase 2 trial is now a 20-patient, single-arm, open-label study evaluating a 60mg dose, as this dose showed a good therapeutic potential. The primary endpoint is a 50% or greater reduction in UPCR at six months for patients with a UPCR above one. Dr. Henig also affirmed that Kezar is exploring expanding its geographic footprint for trials to mitigate enrollment delays.

Matthew Phipps of William Blair requested confirmation of significant changes to the MISSION Phase II trial design, including the move to a single-arm, open-label format with a 60mg dose, and asked about enrollment criteria, endpoint definitions, and plans to expand clinical sites to mitigate delays.

Answer

Chief Medical Officer Noreen Henig confirmed the MISSION Phase II trial is now a 20-patient, single-arm, open-label study using a 60mg dose, with the primary endpoint being a 50% or greater reduction in UPCR at 6 months. She stated the changes reflect learnings from Phase Ib and a focus on real-world patient populations. She also confirmed the company is expanding its geographic footprint for trials.