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    Michael DiFiore • Leerink Partners

    Michael DiFiore's questions to Mineralys Therapeutics Inc (MLYS) leadership

    Michael DiFiore's questions to Mineralys Therapeutics Inc (MLYS) leadership • Q2 2025

    Question

    Michael Difiore of Evercore ISI inquired about potential differentiation from AstraZeneca's upcoming Vax HTN data, particularly concerning hyperkalemia rates, and asked for an update on partnership discussions.

    Answer

    CEO Jon Congleton expressed confidence in lorunderstat's well-characterized efficacy and safety profile from four completed trials, noting a low 0.6% rate of significant hyperkalemia. He stated it was premature to compare data before AstraZeneca's release. Regarding partnerships, Congleton confirmed ongoing interest in ex-U.S. and U.S. collaborations to maximize the drug's reach and value.

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    Michael DiFiore's questions to Mineralys Therapeutics Inc (MLYS) leadership • Q1 2025

    Question

    Michael DiFiore of HC Wainwright & Co. inquired about the acceptable level of hyperkalemia in the Explore-CKD trial and whether lorundrostat's efficacy and safety would be similar to competitor cadrostat's Phase II CKD trial results.

    Answer

    Executive Jon Congleton explained that the company has not defined a specific acceptable level of hyperkalemia, noting that specialists are comfortable managing it to achieve blood pressure and kidney function benefits. He stated it was too early to compare efficacy directly with competitors but anticipates a clinically meaningful blood pressure reduction for lorundrostat consistent with its established profile.

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    Michael DiFiore's questions to Mineralys Therapeutics Inc (MLYS) leadership • Q4 2024

    Question

    Michael DiFiore of Leerink Partners questioned the confidence in extrapolating Phase II Target-HTN results from a small patient group to the larger pivotal studies, and asked about the mechanisms of action in the OSA and CKD trials.

    Answer

    Executive Jon Congleton expressed confidence in the 50mg dose for the pivotal program, citing the totality of evidence and exposure-response data from the Phase II trial. Chief Medical Officer Dr. David Rodman explained that in the OSA trial, improvement is likely driven by reduced fluid shifts and inflammation, not fibrosis. For the CKD trial, he noted the study design, including a run-in period and crossover structure, is built to assess and account for any potential confounding effects from SGLT2 inhibitors.

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    Michael DiFiore's questions to Mineralys Therapeutics Inc (MLYS) leadership • Q3 2024

    Question

    Michael DiFiore of Evercore ISI inquired about the Target-HTN trial's nighttime blood pressure data, specifically the lack of nocturnal dipping in the 50mg group, and asked for clarification on two early-stage safety signals: a case of sinus tachycardia and a case of dysgeusia.

    Answer

    Dr. David Rodman, Chief Medical Officer, explained that the 100mg cohort showed a normal nighttime response, suggesting the 50mg data was skewed by a high number of 'white coat hypertension' subjects, which reduced the sample size in sensitivity analysis. He attributed the sinus tachycardia to a predictable pharmacodynamic effect of volume depletion at a very high, non-therapeutic dose (360mg) and noted the single case of dysgeusia has not been a recurring issue in subsequent trials.

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    Michael DiFiore's questions to Amylyx Pharmaceuticals Inc (AMLX) leadership

    Michael DiFiore's questions to Amylyx Pharmaceuticals Inc (AMLX) leadership • Q2 2025

    Question

    Michael Difiore questioned the potential for payers to enforce step-edits with non-approved therapies for PBH and sought clarity on the PSP trial's interim analysis, particularly the impact of varied treatment durations.

    Answer

    Co-CEO & Co-Founder Josh Cohen stated that payer step-edits are not anticipated due to the lack of clinical evidence and low satisfaction with existing off-label therapies. Chief Medical Officer Dr. Camille Bedrosian clarified that the PSP analysis will be based on all patients completing 24 weeks, but all available longer-term data will also be considered.

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    Michael DiFiore's questions to Amylyx Pharmaceuticals Inc (AMLX) leadership • Q1 2025

    Question

    Michael DiFiore of Leerink Partners questioned the need for a large patient education campaign for Avexitide in post-bariatric hypoglycemia (PBH), asking if it targets undiagnosed patients or aims to expand into less symptomatic groups. He also inquired about the efficacy benchmark for the upcoming interim data in the Progressive Supranuclear Palsy (PSP) trial, specifically regarding the expected placebo decline and what would constitute a clinically meaningful improvement on the PSP rating scale.

    Answer

    Co-CEO Justin Klee clarified that PBH is well-known among endocrinologists and patients due to its severity, but education is crucial as it's a rare disease with no prior treatments. Regarding PSP, Co-CEO Joshua Cohen stated the ORION trial is 80% powered to detect a 30% effect on the PSP rating scale. He noted that the decision to advance will be based on all data, not just the primary endpoint, and that KOLs have suggested even a single-point difference could be meaningful in this severe, progressive disease.

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    Michael DiFiore's questions to Amylyx Pharmaceuticals Inc (AMLX) leadership • Q4 2024

    Question

    Michael DiFiore of Leerink Partners inquired about the clinical trial design for two of Amylyx's key programs. He asked why the Phase III LUCIDITY trial for post-bariatric hypoglycemia (PBH) was limited to Roux-en-Y gastric bypass patients, and how efficacy would be interpreted in the PSP ORION study given the use of different rating scales in the U.S. and ex-U.S.

    Answer

    Chief Medical Officer Dr. Camille Bedrosian explained the LUCIDITY trial's focus on Roux-en-Y patients is to minimize heterogeneity, as this is where Amylyx has the most data, though they believe the drug will be applicable to all PBH patients. Co-CEO Justin Klee added that the Roux-en-Y market is substantial. Regarding the PSP trial, Co-CEO Joshua Cohen stated that the 10-item and 28-item PSP rating scales are highly consistent, and they expect similar results from both endpoints.

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    Michael DiFiore's questions to Halozyme Therapeutics Inc (HALO) leadership

    Michael DiFiore's questions to Halozyme Therapeutics Inc (HALO) leadership • Q2 2025

    Question

    Michael DiFior of Evercore ISI inquired about the Merck litigation, asking if the increasing number of instituted PGRs strengthens Merck's position or affects settlement timing. He also asked if potential partner deal conversations have slowed in anticipation of the final CMS Part B guidance.

    Answer

    President and CEO Dr. Helen Torley stated that settlement timing is in Merck's hands and that the ultimate arbiter of infringement is the district court, where Halozyme has patents not subject to the PTAB process. She also confirmed that deal conversations have not slowed down, as the IRA is not a major factor, especially since many partners are considering subcutaneous formulations from the early stages of development.

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    Michael DiFiore's questions to Halozyme Therapeutics Inc (HALO) leadership • Q1 2025

    Question

    Michael DiFiore of Evercore ISI asked if AstraZeneca's deal with Alteogen suggests large pharma is now willing to risk patent litigation rather than partner with Halozyme. He also questioned if any existing or potential ENHANZE partners have paused negotiations while awaiting the outcome of the Merck litigation.

    Answer

    Dr. Helen Torley, President and CEO, stated that no current or potential partners have paused discussions due to the litigation, emphasizing ENHANZE's position as the derisked market leader. She asserted that companies signing with Alteogen, including AstraZeneca, had previously approached Halozyme for targets that were already exclusively licensed to other partners.

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    Michael DiFiore's questions to Halozyme Therapeutics Inc (HALO) leadership • Q4 2024

    Question

    Michael DiFiore asked if 2025 could be the year VYVGART subcutaneous sales exceed IV sales and whether the three undisclosed pipeline products represent new deals or expansions of current partnerships.

    Answer

    President and CEO Dr. Helen Torley expressed excitement for VYVGART's growth but stated it would be inappropriate to comment on the subcu vs. IV sales timeline, as partner Argenx has not provided that guidance. She clarified that the three undisclosed products are from current partners, and any new deals would be incremental to those.

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    Michael DiFiore's questions to Halozyme Therapeutics Inc (HALO) leadership • Q3 2024

    Question

    Michael DiFiore of Evercore ISI asked for an update on expectations for new collaboration deals before year-end. He also questioned how licensees of the new MDASE platform would manage development and regulatory challenges without Halozyme's traditional support services.

    Answer

    President and CEO Dr. Helen Torley pointed to the updated collaboration revenue guidance of $130M-$150M as the current outlook but affirmed that efforts to sign new deals continue. She explained that MDASE licensees would be responsible for their own development and regulatory processes, as Halozyme would only license the IP, unlike the full support provided with ENHANZE partnerships.

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    Michael DiFiore's questions to TG Therapeutics Inc (TGTX) leadership

    Michael DiFiore's questions to TG Therapeutics Inc (TGTX) leadership • Q2 2025

    Question

    Michael Difiore asked for a breakdown of the intravenous (IV) anti-CD20 market, specifically how the 60% of patients not choosing a subcutaneous option are split between BRIUMVI and its IV competitors. He also questioned if a payer push toward at-home therapies could accelerate a market shift to subcutaneous options.

    Answer

    Chief Commercial Officer Adam Waldman stated that within the physician-administered IV segment, BRIUMVI is capturing approximately one out of every three new patients. Regarding payer dynamics, Waldman noted that while a significant push for at-home therapies is not currently observed, it is a possibility, which strategically validates the company's development of a subcutaneous BRIUMVI formulation.

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    Michael DiFiore's questions to TG Therapeutics Inc (TGTX) leadership • Q1 2025

    Question

    Michael DiFiore asked for an update on gross-to-net trends, the impact of the Part D redesign, and when the company expects to fully deplete its pre-launch inventory reserves affecting gross margin.

    Answer

    Chief Commercialization Officer Adam Waldman clarified there was no material change in gross-to-net and that the Part D redesign is not relevant for Briumvi, a Part B drug. Chief Financial Officer Sean Power confirmed that the pre-commercial inventory has been fully depleted, meaning the gross margin reported this quarter is the 'fully baked number' expected going forward.

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    Michael DiFiore's questions to TG Therapeutics Inc (TGTX) leadership • Q4 2024

    Question

    Michael DiFiore asked for an update on the pivotal trial design for the subcutaneous formulation of BRIUMVI and inquired about the gross-to-net expectations for the remainder of the year.

    Answer

    Chief Commercialization Officer Adam Waldman stated that gross-to-net is expected to be in the 70% to 75% range, with some quarterly fluctuations. CEO Michael Weiss added that the subcutaneous trial design is not yet finalized as they are still gathering data, and it remains to be determined whether the dosing regimen will be every two or three months.

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    Michael DiFiore's questions to TG Therapeutics Inc (TGTX) leadership • Q3 2024

    Question

    Michael DiFiore from Evercore ISI inquired about any inventory channel dynamics in Q3 and asked for the TRx script count and new patient hub enrollments, noting their absence from the press release.

    Answer

    Chief Commercialization Officer Adam Waldman confirmed there were no changes to inventory levels, which remain normal. He explained that the company is moving away from reporting hub enrollment numbers because they are becoming a less accurate measure of growth as the hospital business, which uses the hub less, now accounts for 55% of their business. The focus will be on revenue guidance going forward.

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    Michael DiFiore's questions to Elanco Animal Health Inc (ELAN) leadership

    Michael DiFiore's questions to Elanco Animal Health Inc (ELAN) leadership • Q1 2025

    Question

    Michael DiFiore asked if the Zenrelia label change request was progressing faster than expected and for color on vets' willingness to use it as a first-line treatment. He also asked about the discrepancy between lower cattle-on-feed numbers and strong Experior performance.

    Answer

    CEO Jeff Simmons clarified there are two workstreams for the Zenrelia label: a shorter-term language change with an expected H2 2025 answer, and a longer-term trial for a full label change. He noted a nice ramp in vets moving Zenrelia to first-line treatment. CFO Todd Young explained Experior's strong performance is due to expanded market access from the heifer clearance.

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    Michael DiFiore's questions to Elanco Animal Health Inc (ELAN) leadership • Q4 2024

    Question

    Representing Umer Raffat, Michael DiFiore asked about specific omnichannel strategies to mitigate cannibalization from the Credelio Quattro launch and the expected impact of potential tariffs on input costs and the supply chain.

    Answer

    President and CEO Jeff Simmons explained that Elanco is less concerned about cannibalization with Quattro due to its smaller notional share in the U.S. parasiticide market and early tracking that shows less cannibalization than with other recent launches. The focus is on activating pet owners to drive new interest. CFO Todd Young stated that the only current tariff impact is from China, costing $3-4 million in 2025, which is factored into guidance. He noted that potential tariffs on Mexico and Canada would have less impact due to a smaller manufacturing footprint there.

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    Michael DiFiore's questions to Elanco Animal Health Inc (ELAN) leadership • Q3 2024

    Question

    Michael DiFiore, on behalf of Umer Raffat from Evercore ISI, asked about the Zenrelia vaccination booster study results and if it was a concern for veterinarians. He also asked about market enthusiasm for Credelio Quattro in regions where tapeworm is not endemic, and for the driver behind the increased 2024 innovation sales guidance.

    Answer

    CEO Jeff Simmons responded that the Zenrelia booster study was well-received by veterinarians and has been helpful in technical conversations. On Credelio Quattro, he emphasized that its appeal is driven by the major trend towards broad-spectrum coverage, its tick efficacy, and heartworm prevention, not just tapeworm coverage. CFO Todd Young explained that the increased 2024 innovation guidance was driven by stronger-than-expected performance from Experior, AdTab, and Credelio Plus.

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    Michael DiFiore's questions to Biogen Inc (BIIB) leadership

    Michael DiFiore's questions to Biogen Inc (BIIB) leadership • Q1 2025

    Question

    Michael DiFiore, on for Umer Raffat, noted that a competitor's drug launch was tracking ahead of LEQEMBI's and asked if Biogen had paved the way and about current competitive dynamics.

    Answer

    CEO Christopher Viehbacher acknowledged that Biogen and Eisai's early work to establish treatment pathways likely did pave the way for competitors. He stated that the current dynamic is focused on which drug a patient is initiated on, as switching is not expected. He reiterated that the primary goal is to collectively grow the overall market for Alzheimer's treatments, which remains vastly underserved.

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    Michael DiFiore's questions to Royalty Pharma PLC (RPRX) leadership

    Michael DiFiore's questions to Royalty Pharma PLC (RPRX) leadership • Q3 2024

    Question

    Michael DiFiore asked for an outline of the expected timeline for Nictimbo's U.S. market penetration and ramp to peak sales, as well as management's thoughts on its probability of success in the Idiopathic Pulmonary Fibrosis (IPF) indication.

    Answer

    Marshall Urist, EVP, Head of Research and Investments, stated that due to significant unmet patient need and partner Incyte's strong market presence, they are hopeful for material demand upon launch. He clarified that the base investment case is focused on the current chronic GVHD approval, which is expected to generate attractive returns, while potential success in IPF or earlier lines of GVHD represents exciting upside.

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