Srikripa Devarakonda

Srikripa Devarakonda asked about the expected cadence for the EU launch and its contribution to 2026 growth, and whether the reported SG&A includes the European salesforce or if further increases are expected.

Answer

CFO Mardi Dier confirmed SG&A already includes expenses for building out the Germany salesforce. She stated that Madrigal is disciplined with country-by-country expansion, aiming for a two-to-three-year positive contribution metric. CEO Bill Sibold added that while the Germany launch is exciting with an outstanding team, it will take time to 'wire the system' and navigate reimbursement, so 2026 growth will be predominantly from U.S. sales, with Europe adding a non-significant amount.

Srikripa Devarakonda asked about the expected cadence for the EU launch and its contribution to 2026 growth, and whether the reported SG&A includes the European salesforce or if further increases are anticipated for Europe.

Answer

Mardi Dier, Chief Financial Officer, confirmed that SG&A expenses include the build-out for Germany, the initial EU launch country, and will increase with each new country as Madrigal maintains a disciplined approach. She noted that while the EU launch began in Q3 with de minimis revenue, its impact on 2026 growth will be modest, with robust sales growth predominantly driven by the U.S. Bill Sibold, Chief Executive Officer, added that the German team is strong, but 'wiring the system' and navigating reimbursement in each country takes time.

Srikripa Devarakonda asked if Scholar Rock would provide launch guidance post-approval and questioned how the President's executive order on drug pricing might impact its strategy for apitegromab, an orphan drug, in the U.S. and ex-U.S. markets.

Answer

CEO David Hallal stated the executive order does not change their global plans and that pricing will reflect the drug's value in a rare disease, which should have a limited budget impact. COO Keith Woods confirmed no launch guidance would be provided at this time but pointed to a steady launch trajectory influenced by factors like hospital formulary processes.

Srikripa Devarakonda of Truist Securities asked about the necessary catalysts for a significant sales inflection for LOQTORZI, the level of physician awareness, and any concerns regarding recent leadership and staffing changes at the FDA.

Answer

CEO Dennis Lanfear and Chief Scientific and Development Officer Dr. Theresa Lavallee addressed the FDA, stating that their strategy of submitting high-quality, well-reasoned data packages is an advantage amid agency turnover. Executive Vice President, Commercial, Sameer Goregaoker, discussed LOQTORZI, highlighting the 15% Q1 end-user demand growth and new account acquisition. He noted that while Q1 was impacted by a sales force restructure, he expects accelerated growth in Q2 and beyond, emphasizing a steady ramp-up due to the rarity of nasopharyngeal carcinoma (NPC).

Srikripa Devarakonda from Truist Securities asked about specific learnings from other clinical trials in the NK3R space that could help optimize the trial design for ABCL635. She also inquired about the potential to expand the NK3R program beyond VMS, noting the target's history in drug development.

Answer

President and CEO Dr. Carl L. Hansen responded that the clear development path established by two recently successful products is a major advantage, clarifying endpoints and patient populations. He reiterated that AbCellera's Phase I trial is designed to de-risk the program early by assessing safety, biomarkers, and efficacy. Dr. Hansen stated he was not aware of NK3R development in neurological indications, distinguishing it from NK1R, and did not comment on expansion potential beyond VMS at this early stage.

Srikripa Devarakonda of Truist Securities requested more details on the ABCL635 program, including its target class (GPCR/ion channel), market size, and competitive landscape, noting the historical challenges with such targets.

Answer

President and CEO Dr. Carl Hansen confirmed ABCL635 is a first-in-class antibody against a multipass transmembrane protein for an endocrine or metabolic condition with an addressable market conservatively over $2 billion. He declined to provide further details on the specific target or indication for strategic reasons, stating they will be disclosed upon CTA approval.

Speaking on behalf of Srikripa Devarakonda, Alexander Xenakis asked for more detail on the exploration partner access program, including any potential benchmarks for the number of partners who might adopt it and the expected speed of the rollout.

Answer

Matthew Foehr, President and CEO, explained that while it's difficult to provide exact numbers, a specific portion of their 95 partners are ideal candidates, and preliminary conversations have been 'overwhelmingly positive.' He noted that the company has deep technical relationships that help identify likely adopters and pointed to the upcoming PEGS conference for a more detailed launch, highlighting the new revenue streams from the instrument, consumables, and software.

Srikripa Devarakonda from Truist Securities requested more color on the new licenses with Incyte and Photinia and asked about therapeutic area trends, particularly how the OmnidAb platform is expanding opportunities.

Answer

President and CEO Matthew Foehr declined to comment on the specific therapeutic areas for the Incyte and Photinia deals but confirmed they have broad platform access. He highlighted that the OmnidAb platform continues to drive diversification, attracting significant partner interest in high-value CNS targets and growing interest in radiopharma applications.

Srikripa Devarakonda of Truist sought to confirm if Cytokinetics had asked the FDA about the need for a REMS and, based on the feedback, concluded it was reasonable not to submit one initially.

Answer

Robert I. Blum, President and CEO, responded succinctly, stating, "I think that's correct."

Srikripa Devarakonda of Truist Securities asked if the 6-month duration of the MAPLE trial is sufficient to demonstrate a difference in cardiac remodeling.

Answer

Fady Malik, EVP of R&D, confirmed that 6 months is sufficient. He referenced data from the SEQUOIA trial, which already showed positive structural changes at 6 months with aficamten. He emphasized that the key differentiator in MAPLE will be the contrast with beta-blockers, which are not expected to show any such remodeling effects in that timeframe.

Srikripa Devarakonda of Truist asked about the lymphoma study's clinical trial site expansion, whether the 12-to-18-month enrollment timeline remains on track, and if there were any concerns about their FDA agreement given recent changes at the agency.

Answer

Chief Development Officer Jonathan Zung confirmed the current site count reflects recent expansions. President and CEO James Dentzer addressed the FDA question, stating Curis has no concerns about its existing agreement, feeling fortunate to have secured it before recent industry-wide challenges with the agency emerged.

Srikripa Devarakonda asked about the bimagrumab combination trial, inquiring about the timing of data release and how to frame expectations for the results.

Answer

Dr. Dan Skovronsky, Chief Scientific Officer, clarified that two Phase II trials exist. The first, in combination with semaglutide (conducted before acquisition), will be disclosed first. The ongoing trial of greater interest is in combination with tirzepatide, and no disclosure timing has been set for that. He reminded that the agent was designed to test for a positive effect on lean muscle mass alongside fat mass reduction.

Srikripa Devarakonda asked for clarification on the HS market slide, questioning if the 46,000 eligible patients for povorcitinib represents the current market and how Incyte anticipates penetration across the different patient segments.

Answer

CEO Herve Hoppenot clarified the slide depicts the market in 2027 at povorcitinib's launch. He outlined three target segments, with the largest initial opportunity being patients previously treated with biologics. Executive Matteo Vena added that the growing churn between existing therapies represents a significant unmet need.

Srikripa Devarakonda of Truist Securities asked about the growth drivers for Jakafi in polycythemia vera (PV), inquiring about the patient population fueling uptake and whether growth is from new patients or treatment duration. She also asked about any additional life cycle management plans for PV beyond Rux XR and the V617F inhibitor.

Answer

Herve Hoppenot, CEO, explained that PV growth is driven by earlier treatment initiation, supported by data from the MAGIC study showing a reduction in thrombosis. This is leading to new patient flow, and he expects PV to become Jakafi's largest indication over time. He confirmed that the V617F inhibitor is the key next-generation asset for PV, as the mutation is present in the vast majority of cases.

Srikripa Devarakonda from Truist Securities asked about the competitive landscape for Incyte's CDK2 program following a competitor's discontinuation and whether additional data would be released before moving to pivotal trials.

Answer

An unnamed executive stated that Incyte believes it is ahead in developing a CDK2 inhibitor for ovarian cancer, with over 200 patients treated and plans to start registrational studies next year. While acknowledging competition from ADCs, he highlighted that their CDK2 inhibitor could be differentiated, particularly in the maintenance setting in combination with bevacizumab, which could be an ideal fit for a well-tolerated oral molecule.

Srikripa Devarakonda asked about expectations for the upcoming RYZ101 data in small cell lung cancer and whether recent comments from the FDA Commissioner about changes at the agency have had any impact on Bristol's operations or timelines.

Answer

CMO Samit Hirawat stated that the Phase I RYZ101 study will primarily assess safety, with efficacy compared to historical controls, to inform future development. He also confirmed that, from Bristol's perspective, there has been no impact from FDA changes, with approvals and meetings proceeding on or ahead of schedule.

Srikripa Devarakonda inquired about the enrollment status and target patient subsets for the ARV-393 (BCL6 degrader) trial and its potential positioning in the non-Hodgkin lymphoma landscape. She also asked for commentary on the recent departure of the Chief Commercial Officer.

Answer

Chief Medical Officer Noah Berkowitz reported that enrollment for ARV-393 is progressing well and highlighted its potential for combination therapies due to a favorable preclinical safety profile, with more data to come at AACR. CEO John Houston explained the CCO's departure was for personal reasons and assured that the commercial team remains strong under the leadership of Interim CCO Alex Santini, with no disruption to launch plans.

Srikripa Devarakonda of Truist Securities asked if Kymera expects to see similar STAT6 degradation levels across different tissues and if the profile observed in healthy volunteers is expected to be consistent in patients.

Answer

CEO Nello Mainolfi confirmed that preclinical data showed consistent, robust degradation (>90%) across tissues. He expressed confidence that this will translate from healthy volunteers to patients, citing the consistent degradation profile seen in their IRAK4 program as a relevant precedent.

Srikripa Devarakonda asked about Pfizer's strategy for its breast cancer franchise, including its CDK4 inhibitor and vepdegestrant, in an evolving competitive landscape and what would constitute competitive data for vepdegestrant.

Answer

Executive Chris Boshoff expressed high confidence in the breast cancer pipeline, describing the CDK4 inhibitor as a potential best-in-class replacement for current CDK4/6 inhibitors. He noted the plan to combine it with vepdegestrant in a first-line study and also highlighted the potential of another first-in-category molecule, KAT6.

Srikripa Devarakonda inquired about the ponsegromab program for cachexia, asking about the requirements for a registrational trial and the potential market size of the drug.

Answer

Chief Scientific Officer Mikael Dolsten explained that initial registration would likely be based on endpoints similar to the successful Phase II study, such as body weight, with the goal of later demonstrating harder outcomes like survival. An executive, likely Chief Strategy and Innovation Officer Andrew Baum, noted that cachexia is a massive unmet need, and the market size will depend on whether the drug is used for supportive care or demonstrates outcome benefits, which will inform pricing.

Srikripa Devarakonda inquired about the recent AstraZeneca milestone, asking for details on the partnership's economics, the timeline for future updates, and how the achievement validates Absci's AI platform for de novo antibody design.

Answer

Founder and CEO Sean McClain confirmed the milestone as a significant validation of the platform's ability to deliver a novel binder in just six months. CFO and CBO Zachariah Jonasson clarified the deal's economics, correcting an earlier misstatement to confirm the partnership is valued at $247 million, including upfront fees, milestones, and an undisclosed royalty.

Asked for clarification on the FDA's feedback from the Type C meeting, specifically about any protocol changes, the need for further FDA meetings before proceeding with the study, and whether the new AlloNK/IL-2 cohort is a requirement for accelerated approval.

Answer

The company confirmed that the FDA did not request any protocol changes, but Affimed is adding the AlloNK/IL-2 cohort to address the contribution of components. They do not need to consult the FDA again to proceed with the study. The new cohort is considered necessary for an accelerated approval submission as the agency wants to see the contribution of each component.

Srikripa Devarakonda of Truist Securities sought more detail on the upcoming TIDAL data release beyond ORR, including any durability data, and asked for an update on the COASTAL trial's progress, such as site activation and potential hurdles from the Delta variant.

Answer

Dan Gold, President and CEO, clarified that the initial TIDAL readout will focus on the primary endpoint of ORR, as durability data is still immature due to the pace of enrollment. He assured transparency on safety data when it is sufficiently clean. Regarding the COASTAL trial, he reported it targets over 500 patients across nearly 200 global sites, with site activation progressing well and no significant COVID-related delays being observed.