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CFO Jesse Neri attributed stable gross margins to organizational rightsizing and investments in manufacturing efficiency. CEO Dr. Mark Strobeck added that the departed customer's business had lower margins, mitigating the impact of the revenue loss. Neri confirmed customer concentration risk has significantly decreased, with the former top customer now at ~10% of revenue, down from ~45%. Dr. Strobeck also confirmed that Rockwell is actively supplementing supply for customers affected by a competitor's product recall, reinforcing Rockwell's position as a reliable supplier.

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President and CEO Dr. Mark Strobeck detailed that international expansion is focused on Latin America and that the company is evaluating the best method for West Coast entry, potentially a new facility. He affirmed that the opportunity to replace lost revenue is significant by targeting customers in their existing footprint, internationally, and on the West Coast. Dr. Strobeck clarified that the current 2025 guidance is based on the existing customer base, meaning any new contracts would provide potential upside.

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The company is expanding internationally, primarily in Latin America, and is considering establishing a facility on the West Coast after reaching a critical mass of customers there. Management believes there is a large enough opportunity to replace a significant portion of the lost revenue through expansion in their existing footprint, Latin America, and the West. The reaffirmed revenue guidance is based on the current customer base, so any new customers signed would represent potential upside.

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CEO Dolev Rafaeli explained that the company has petitioned CMS for temporary G codes to accelerate expanded reimbursement, with a final rule expected in November 2025. Regarding Elevate360, he provided a detailed case study of a successful clinic and committed to sharing broader metrics in the future. He also confirmed that while the primary focus remains on the high-upside XTRAC device, the TheraClear installed base is still growing and expected to approach 200 units by year-end.

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The company has submitted a comprehensive application to CMS for temporary G codes and increased reimbursement rates, with a final rule expected in November. While specific metrics for the Elevate360 program were not provided, anecdotal evidence shows significant revenue growth in participating clinics. The primary focus remains on the XTRAC business due to its larger potential, though TheraClear is still a growing part of the business.

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The domestic business has minimal direct tariff impact, with the main effect being on outbound international sales and service. The XTRAC installed base is considered at a low point, and the focus is on both improving utilization in existing accounts via the "Elevate 360" program and expanding into new, productive clinics. The Elevate 360 program is currently being applied to about 100 accounts (roughly 10% penetration) and has shown significant success in turning around underperforming clinics and driving expansion.

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Executive Dolev Rafaeli clarified that tariffs primarily threaten outbound international sales and service, with minimal direct impact on the domestic supply chain. He stated the XTRAC installed base is at a low point and the strategy involves both removing underperforming devices and redeploying them to more productive clinics. Rafaeli provided a detailed overview of the Elevate 360 consulting program, explaining how it uses analytics to drive utilization and has expanded from 5 to nearly 100 accounts, showing significant success in boosting revenue and expanding device placements within partner clinic groups.

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Dolev Rafaeli (executive) explained that account performance is measured against a fixed expense threshold of approximately $15,000-$16,000 per device. Accounts falling below this run rate are either targeted for performance improvement through a consultative process or have their device removed. Rafaeli noted that good new accounts are often former customers returning or clinics with a high pre-existing patient volume. He anticipates a higher rate of removals and placements in the near term to optimize the installed base.

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Chairman and CEO Joseph Sardano stated the company is not providing specific guidance on FDA unit installations but is moving aggressively. He explained that Sensus uses data analytics and targeted digital marketing to help clinics drive patient volume, and confirmed these costs are included in the S&M expense forecast. Regarding the TDI system, Sardano and President Michael Sardano noted that no follow-up questions have been received from the FDA since the March 7th submission, which they view as a positive sign for approval.

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Dr. Lishan Aklog, Chairman and CEO, stated that the Veris pilot feedback was excellent and met all metrics, leading to process improvements but no core platform changes. He clarified that OSU does not have broad exclusivity. Regarding biopharma, Dr. Aklog explained it leverages PAVmed's existing infrastructure and subsidiary financing model, where new ventures raise their own capital, to seize opportunities in a capital-rich sector without straining parent company resources.

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Dr. Lishan Aklog, Chairman and CEO, described the Ohio State agreement as a comprehensive commercial and strategic partnership that includes patient enrollment commitments and establishes them as the first site for the implantable device post-clearance. He projected an FDA submission for the implantable device by late 2024 or early 2025, noting that positive FDA engagement may allow them to avoid a full human clinical trial.

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Executive Jake Singleton noted that the comp spread between system-wide and mature clinics has been consistent for the last 5-6 quarters. Executive Sanjiv Razdan detailed that the guidance is supported by multiple initiatives beyond just pricing, including stronger promotional activity, a new pain-centric marketing message, enhanced digital marketing from a new agency, and the launch of a new mobile app to drive patient engagement.

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Executive Rajiv Kanishka De Silva outlined a two-pronged growth strategy: normalizing order rhythms with new international distribution partners and launching a new body system in the U.S. in the second half of the year. He indicated that the company's cost base is now efficient and the focus is on growing sales, not further significant cuts. He also stated that with manufacturing in Israel and the U.S., they do not anticipate a substantial near-term impact from tariffs.

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The growth strategy involves normalizing ordering rhythms with international distributors and launching a new body system in the U.S. in the second half of the year. The company believes it is operating leanly and does not see significant further cost-reduction opportunities. Regarding tariffs, a substantial near-term impact is not expected as products are manufactured in the U.S. and Israel, which has been protected from recent tariff increases.

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Executive Steven Larosa explained that separate trials for India and Australia are necessary to avoid confounding data due to genetic and comorbidity differences in the populations. Regarding the timeline, he stated that initial safety data for the first cohort is expected in January, with the first set of EV and T-cell data anticipated in the summer of the following year. CEO James Frakes added that the company plans to report data after each cohort completes, rather than waiting for the full study to conclude.

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Executive Robert Banks explained that Nephros is enhancing customer engagement by emphasizing the risks of off-label filter use and offering new installation services. He confirmed the online filter tracker, which sends automated replacement reminders, is on schedule for a Q1 2025 rollout after successful beta testing. Banks described the new HydroGuard UltraFilter as a complementary product that also opens new, higher-flow markets like sterile processing, aligning with emerging ST108 standards and allowing Nephros to compete more effectively.

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CEO Dr. Lishan Aklog clarified that this is a supplemental strategy, not a shift, and part of an "all of the above" approach to drive revenue. While traditional reimbursement will become the dominant pathway after Medicare approval, he noted the concierge and self-insured employer markets are significant and will likely remain a focus. Regarding legislation, Dr. Aklog confirmed they are actively engaged in these efforts, but cautioned that translating state mandates into actual payment from payers is a lengthy process and not a panacea.

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