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Co-Founder, President, and CEO Richard Lowenthal identified the national DTC campaign and the expanded pediatric sales force partnership with ALK as the primary growth drivers. He confirmed the DTC campaign is budgeted through 2026. Chief Commercial Officer Eric Karas added that data shows initial prescriptions for Nefi have a slightly higher number of cartons per patient compared to the market average, a trend supported by a single co-pay program for multiple packs.

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President and CEO Richard Lowenthal confirmed the company is tracking to plan for an inflection point in Q3, driven by the 1mg dose launch and the DTC campaign. He acknowledged prior authorizations are a headwind but are becoming less of an impediment as overall insurance coverage increases and approval rates improve.

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CEO Richard Lowenthal identified the national DTC campaign and the expanded sales force partnership with AOK as the key drivers for H2 growth. He confirmed the DTC campaign is budgeted to continue through 2026. CCO Eric Karas added that the company is observing a slightly higher number of cartons per initial prescription compared to the market historically, a trend encouraged by a single co-pay policy for multiple cartons.

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Chief Medical Officer Dr. Carl Kraus explained that the pediatric study's PK profile was comparable to the adult dose, as intended. He stated that the safety data was also in line with expectations, showing no difference in the character, frequency, or severity of outcomes observed in the pediatric population compared to adults.

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CEO Bobak Azamian confirmed that Tarsus remains on track to initiate the Phase 2 study for its ocular rosacea candidate, TPO4, later in 2025. He highlighted that the team is focused on careful preparation for the trial, including site selection and endpoint validation, as it will be the first-ever study in this new therapeutic category.

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CEO Michael Castagna and SVP Wassim Fares explained the Phase 2 trial's primary endpoint is safety and tolerability, with efficacy as a secondary endpoint to inform the Phase 3 design. The ex-US focus facilitates faster enrollment for the placebo-controlled study. CFO Chris Prentiss stated the Blackstone deal provides flexible, non-dilutive capital to support commercial build-outs, advance the pipeline, and enable rapid action on potential business development opportunities.

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Executive Michael Castagna positioned inhaled nintedanib (MNKD-201) as a potential background therapy for new combination treatments. For delivery, he expressed confidence in their existing device platform, which is widely used for Tyvaso, and noted they are developing a dry powder version of clofazimine, seeing little need for external device collaborations.

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Executive Michael Castagna clarified that TYVASO's contracting dynamics have reached a steady state and no major shifts are expected. For MNKD-201, he outlined a proposed Phase II trial design: a 4-arm, 26-30 week study comparing different doses against a control arm, with the goal of demonstrating comparability to oral nintedanib, potentially with better tolerability.

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Michael Castagna, an executive, explained that the goal for MNKD-101 is to displace ARIKAYCE in the refractory NTM population and eventually target first-line treatment with a future dry powder version. For MNKD-201, he stated the Phase I data confirmed minimal GI side effects and no adverse lung reactions, supporting a proposal to the FDA for a Phase II/III dose-ranging study in 2025.

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Dr. Leigh Peterson, VP of Product Development, stated the Ralinepag study is 80% powered to detect a 0.65 hazard ratio for clinical worsening and is on track. Regarding TETON, she confirmed the statistical plan, including the 'death penalty' imputation method, was developed with recent FDA feedback, and her team has been in ongoing conversations with the agency about the specific models being used.

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CEO Martine Rothblatt highlighted significant internal R&D investment in PAH and ILD. CFO James Edgemond then detailed the three-pillar capital allocation strategy: 1) internal R&D and CapEx, 2) external corporate development for acquisitions and licensing, and 3) returning cash to shareholders, noting the company has been active across all three areas recently, including the $1 billion share repurchase in 2024.

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While Chairperson and CEO Dr. Martine Rothblatt deferred the IP question, President and COO Michael Benkowitz explained the contracting strategy. He stated the company proactively increased rebates to lock in payers ahead of new competitors, ensuring rebate dollars are flowing and making payers less likely to accept contracts that would disadvantage Tyvaso.

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Executive James Edgemond confirmed that the company's current manufacturing capacity is sufficient to support a potential IPF approval for Tyvaso DPI without additional investment. Regarding capital allocation, he noted the completion of a $1 billion ASR and stated that the company will continue to thoughtfully evaluate all priorities, including future ASRs, without making a specific commitment.

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CEO Faheem Hasnain confirmed that stringent criteria, which involved screening about double the number of patients ultimately enrolled, contributed to the timeline but also reflected high demand. CMO Dr. Richard Aranda stated the study remains over 90% powered as it was designed for this specific patient population. CFO & COO Bryan Giraudo reiterated confidence in seralutinib's safety profile, viewing it as a competitive advantage. Mr. Hasnain added that this safety profile, combined with efficacy, could position the drug for earlier use.

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Executive Ian Estepan acknowledged that the current stock price does not reflect the company's value or growth potential. He stated that management must balance investment in R&D with its capital allocation strategy, and while not being direct about timing or amounts, a buyback is a consideration they are looking at as part of a disciplined approach.

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Executive Talat Imran explained that the transenteric delivery route is inherently more efficient than subcutaneous, leading to rapid onset and less variability, a finding consistent across 19 molecules tested. He stated the Phase 1 study will enroll obese, non-diabetic patients and will be followed by a larger Phase 2a 12-week study testing multiple doses against a placebo.

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Dr. Victor Chong, Chief Medical Officer, stated that payer research has been positive and the company would likely model its commercial strategy on other flexible-dosing drugs like EYLEA high dose and VABYSMO, noting that Clearside's lower cost of goods could allow for competitive pricing. Regarding trial design, he said the powering assumptions are similar to those used for VABYSMO's trials, using a 4.5-letter non-inferiority margin and targeting 90% power.

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Chief Medical Officer Dr. Victor Chong stated the Phase III trial design will be a non-inferiority study with flexible dosing compared to aflibercept 2-milligram, likely in treatment-naive patients. Regarding geographic atrophy, he said the company is exploring small molecules to improve choroidal perfusion and moderate inflammatory cells. Dr. Chong also confirmed the target to begin the Phase III trial is the second half of 2025.

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President and COO Todd Bazemore addressed the script rejection question, stating that while granular data has a lag, the combination of accelerating prescription growth and a decrease in copay assistance program usage strongly suggests rejection rates are falling post-CVS formulary addition. Head of R&D and CMO Kim Brazzell provided an update on KPI-287, confirming that preclinical trials are actively ongoing despite some unexpected delays with CROs, and that the company expects to provide further updates in the coming quarters.

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Todd Bazemore, President and COO, explained that growing coverage will boost revenue by increasing filled prescriptions and improving gross-to-net margins. He noted that currently, 50% of commercial and 70% of Medicare scripts are rejected. He highlighted that improved coverage reduces reliance on costly co-pay assistance programs. Kim Brazzell, Head of R&D and Chief Medical Officer, added that upcoming KPI-287 data will provide updates on pharmacokinetics and efficacy over multiple months from ongoing preclinical studies.

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COO Todd Bazemore explained that recent EYSUVIS script growth has accelerated, with refills up 94% in Q3 vs Q2. He attributed the revenue-to-script gap to increased use of patient assistance programs, impacting gross-to-net. He also noted that optometrists now account for nearly 60% of prescriptions. Chief Medical Officer Kim Brazzell added that KPI-012 is compelling because it targets a broad PCED indication, unlike competitors focused on the narrower neurotrophic keratitis subset.

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