Jeffrey Cohen • Ladenburg Thalmann & Co. Inc.

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CEO Hadar Levy stated that data for the accelerated protocol has been submitted to the FDA, with a potential clearance expected in Q4 2025. He described it as a 'game changer' that shortens treatment from six weeks to six days. Levy also detailed the commercial team, comprising approximately 16 direct sales representatives and 10 practice development specialists. Regarding the TMS 360 system, he noted its planned launch in Q3 2025 alongside the alcohol use disorder trial, with additional feasibility studies underway.

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CEO Mark Baum acknowledged that the specialty portfolio has underperformed but expressed confidence in a rebound, led by a strategic push for Triassence into the ocular inflammation market. He mentioned that new leadership is staffing up for this initiative. He emphasized that while this segment has work to do, expected overperformance from products like IHEZO and VEVYE provides confidence in meeting overall company guidance.

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CEO Mark L. Baum positioned the ImprimisRx business as the foundational platform that provided the commercial credibility to secure key products like IHEEZO and VEVYE. He elaborated on the strategy to convert compounding patients to more profitable, FDA-approved products like VEVYE. Regarding the 'Interior segment,' Baum expressed dissatisfaction with its performance, citing technical revenue recognition issues in Q1 but promising a strategic review to drive significant improvement.

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CEO Mark L. Baum expressed high confidence in the 2025 revenue guidance of over $280 million, citing expected overperformance from VEVYE, continued growth from IHEEZO, and a material contribution from TRIESENCE starting in Q2. Baum explained 'Project Beagle' is a strategy to convert customers from lower-margin compounded products to higher-margin, FDA-approved alternatives, which is financially positive for Harrow and preferred by customers. He cited the potential conversion of MKO Melt as a prime example.

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CEO Mark Baum confirmed the same sales team sells both IHEEZO and TRIESENCE, creating a 'one-two punch' for retina specialists, supplemented by GPO relationships. CFO Andrew Boll added that the G&A infrastructure is largely built, so future OpEx growth will be tied to revenue-generating commercial expansion, allowing profitability to expand. Regarding ImprimisRx, Boll highlighted its strong cash generation and performance, pointing to new segment disclosures in the 10-Q and a path to double-digit growth in 2025.

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President and CEO Massimo Calafiore declined to give geographical specifics for the 7D system but highlighted a 66% growth in U.S. unit placements and noted that earn-out customers are exceeding purchase commitments by over 50%. CFO Julie Andrews confirmed there were no new pricing changes in Q2 beyond the major account contract discussed in Q1, which will continue to have an impact for the rest of the year.

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CEO Massimo Calafiore explained that AccelStim 2.0's key new feature is its integration with the Stim onTrack physician portal, allowing for remote monitoring of patient compliance, similar to other devices in their portfolio. Regarding TrueLok Elevate, he noted the system is in a successful limited release with over 90 cases completed, collecting data to support its benefits in limb salvage for conditions like diabetic foot ulcers. He described it as a single SKU system with accessories, poised to address a large market opportunity.

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CFO Joe Mara stated that quarterly operating expenses are expected to remain relatively flat, with the main financial impact of the sales force expansion hitting in 2026. CEO Dominick Colangelo explained the BARDA RFP responses are due in late August and cover an initial procurement of 2,750 units, but the ultimate timing and revenue impact are not yet quantifiable.

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CEO Dominick Colangelo clarified the MACI Ankle IND is planned for the first half of the year, with study initiation in the second half, and positioned it as a 2030+ opportunity. He explained that the commercial team was already expanded to 17 territories in 2023 to cover both burn products, and the pediatric indication simply adds about 20 pediatric burn centers to their existing call points.

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CEO Nick Colangelo detailed a flexible training process including online materials, cadaver labs, and model knees, noting experienced surgeons may not need extensive training. For the MACI Ankle program, he clarified the initial Phase III study will use a traditional open procedure, as arthroscopic instruments are not yet developed for the ankle, though that could be a future development.

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CEO Xingjuan Chao clarified that pediatric Clarity is a software algorithm that uses the existing, multi-size headbands, which are already cleared for all ages, so no new hardware is required. She explained the typical adoption path starts in the ICU, where EEG is familiar, and success there often drives a pull-through into the ER, as early diagnosis can reduce unnecessary ICU admissions and length of stay.

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CFO Lance Berry responded that both regions continue to show good growth, driven by new product approvals and commercial footprint expansion. He noted that APAC's Q1 growth was slightly lower than the full-year expectation, partly due to being shorted on On-X supply, which will be caught up. He affirmed the company feels very good about these regions as continued growth drivers as they get the full portfolio approved and commercialized.

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CFO Lance Berry confirmed the 100 bps gross margin improvement is a full-year target and stated that AMDS revenue will be included within the stent graft line, not broken out separately. CEO James Mackin confirmed that the 60-patient Endospan data is expected to be presented at the AATS conference in May.

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CFO Lance Berry explained that the tissue business will not have the same elevated growth in Q1 2025 as it did in Q1 2024, which benefited from a price increase that has since been annualized. CEO James Mackin declined to provide country-specific details for LatAm and APAC to protect competitive strategy. Berry also stated that gross margins are expected to remain relatively flat year-over-year until new, higher-margin pipeline products are launched in the U.S.

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Executive Adam Logal provided the pro forma figures, stating the share count is now approximately 790 million with about $129 million in principal remaining on convertible notes. He also confirmed the remaining BioReference business has an annualized revenue baseline between $310 million and $320 million.

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Executive Elias Zerhouni explained the dual agonist program is pursuing both a weekly injectable and a daily oral formulation, targeting patients with diabetes, obesity, and fatty liver disease (NASH/MASH). Executive Phillip Frost added that the Rayaldee launch in China will start small before a broader rollout post-NDA approval. Regarding BARDA, Adam Logal and Phillip Frost clarified that $40-$48 million is expected in 2025, with the total committed $110 million funding activities for the next 1.5 to 2 years.

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