Andreas Argyrides • Oppenheimer & Co. Inc.

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Co-Founder, President & CEO Richard Lowenthal identified the national DTC campaign and the expanded sales force from the ALK partnership as the two primary drivers for growth. He confirmed the DTC campaign is budgeted to continue through 2026. Chief Commercial Officer Eric Karas added that they are seeing a slightly higher number of cartons per initial prescription compared to the market average, a trend encouraged 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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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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CMO Dr. Richard Aranda confirmed the study remains over 90% powered and assumptions are unchanged. CEO Faheem Hasnain stated that stringent enrollment criteria, which involved screening about double the number of patients ultimately enrolled, contributed to the timeline but also significantly enhanced the probability of success. COO Bryan Giraudo and Faheem Hasnain emphasized that seralutinib's on-target design and clean safety profile are expected to be key competitive advantages.

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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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