Mitchell Kapoor • H.C. Wainwright & Co.

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Alan Bash, President of CARVYKTI, confirmed strong demand trends and noted that European launches, especially in Germany, will continue to drive growth. He also mentioned anecdotally that ASCO data is creating buzz among patients. CEO Ying Huang declined to comment on specific pricing but emphasized CARVYKTI's strong health economic value proposition.

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Alan Bash, President of CARVYKTI, noted that outpatient volume is slightly over half and growing steadily, expecting it to reach a 2/3 outpatient vs. 1/3 inpatient mix over time. Interim CFO Jessie Yeung stated that the current $1 billion in cash is sufficient to reach profitability, which is anticipated in 2026, and there is no present need to raise capital.

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Executive Alan Bash responded that by the end of the current year, the company expects to be in a situation where supply fully meets demand. He clarified that while they don't break down the specific sources of growth, the predominant growth will come from the existing 104 activated centers and the expanding referral base into them as community outreach continues.

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CMO Mythili Koneru confirmed they hope to study steroid use formally in the CARTITUDE-6 protocol, which could potentially lead to a label update. SVP of Commercial Development, Steven Gavel, stated there are no payer barriers for the second-line indication, as insurers value the overall survival benefit and potential for cost savings from outpatient use.

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President and CEO John Leonard explained that trial participants are "high quality" patients who are not out of options; many are coming off effective standard-of-care drugs. He interprets the robust enrollment across all Phase 3 programs as strong evidence that both patients and physicians are motivated by and embracing the concept of a permanent, one-time treatment for their diseases.

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CEO John Leonard anticipates that tafamidis will be a generic drug by the time Nex-z launches, which should minimize payer concerns about covering both. He stressed that the MAGNITUDE trial is designed with sufficient patients on baseline tafamidis to demonstrate a clinical benefit on top of the stabilizer, ensuring strong clinical evidence to support its use, regardless of payer views.

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CFO Nicole LaBrosse explained that guidance is updated based on the latest trend data, with recent outperformance from key products supporting the raise. President and CEO Dr. Helen Torley added that the dynamic nature of multiple growth catalysts has led to partner overperformance. Regarding Merck, Dr. Torley speculated they are challenging new patents as they are issued but reiterated that the key focus remains the district court infringement case.

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Dr. Helen Torley, President and CEO, and Nicole LaBrosse, CFO, explained that while DARZALEX remains a key contributor, products like VYVGART Hytrulo and OCREVUS are expected to become very important. LaBrosse noted that the next wave of products represents a $35 billion market opportunity by 2028, compared to $20 billion for DARZALEX and Phesgo, indicating a future shift in the royalty mix. On M&A, Torley stated the focus is on drug delivery platform technologies with licensing models that generate durable royalties. She emphasized they are not in a hurry and it was premature to comment on deal size or specific timing.

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President and CEO Dr. Helen Torley positioned ENHANZE as the "gold standard" and primary focus for partnerships. She described the MDASE opportunity as an emerging field for companies that may be unable or unwilling to use ENHANZE but are developing a modified hyaluronidase. While not quantifying the opportunity, she framed it as an additional, distinct growth driver for Halozyme's IP portfolio.

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Executive Dave Gancarz and Dr. Jack West clarified that the HARMONi-2 trial was designed for PD-L1 positive patients and did not include the negative population. They explained that a separate trial, such as the all-comer HARMONi-3 (in combination with chemotherapy), would be required to seek approval in the PD-L1 negative setting. Regarding the next data update, Gancarz indicated it would be a planned analysis with more mature data and a larger alpha spend, making a p-value report more likely.

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Executive Dave Gancarz clarified that HARMONi-2 was designed for PD-L1 positive patients only. He, along with Dr. H. Jack West and Dr. Allen Yang, explained that approval in the PD-L1 negative setting would require a different trial, like the all-comer HARMONi-3 or HARMONi-6 studies. Regarding the next OS update, he noted it would be a planned analysis with more mature data, making a p-value more likely, though the decision rests with Akeso.

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An executive highlighted that Summit's independence allows it to combine ivonescimab with the best available therapies. Manmeet Soni, COO & CFO, explicitly stated the Pfizer deal does not preclude other partnerships. Regarding trial enrollment, Mr. Soni acknowledged a patient overlap but does not expect significant competition due to HARMONi-3's head start and the use of different clinical sites for HARMONi-7.

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Executive Dave Gancarz clarified the HARMONi-3 expansion targets a similar population to the KEYNOTE-189 study. CFO Manmeet Soni noted that a specific enrollment split between squamous and non-squamous has not been disclosed. Regarding the HARMONi trial, Soni reiterated it is their "fast-to-market" strategy with data expected mid-2025, and CMO Dr. Allen Yang added that approvals in this setting have historically been based on PFS.

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Chairman and CEO Robert Duggan stated that while they are in discussions with the FDA, it is unlikely they can file for approval in all regions based solely on HARMONi-2 data, though it can be leveraged in future studies. Chief Medical Officer Dr. Allen Yang explained that while response rates increase with higher PD-L1 expression, ivonescimab shows strong activity across the entire spectrum, with a notable relative benefit in the low PD-L1 population compared to other PD-1 agents.

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President and CEO Douglas Ingram stated that based on recent interactions with the FDA's OTP, he has seen no changes in their innovative approach. He expressed confidence that the FDA will remain a science-based organization focused on modernizing drug development, noting recent public statements from new leadership supporting the use of biomarkers in rare disease, which aligns with Sarepta's strategy.

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