Jeffrey Cohen

Jeffrey Cohen asked for a breakdown of OpEx for the 2026 guidance, specifically concerning sales force expansion and R&D, and whether 2026 MACI Arthro growth is expected to be driven by new surgeons or repeat surgeons, inquiring about the remaining surgeon reach.

Answer

Joe Mara, Vericel's Chief Financial Officer, guided total OpEx to approximately $220 million for 2026, identifying key drivers as the sales force expansion (roughly 30 people, approximately $10 million annually) and increased R&D for the MACI ankle trial. Nick Colangelo, Vericel's President and Chief Executive Officer, stated that the sales force and MACI Arthro combined increase reach, expecting continued surgeon training for MACI Arthro, but with a focus on depth of penetration within existing surgeons' practices as a key growth driver.

Jeffrey Cohen asked for a breakdown of the 2026 OpEx guidance, specifically concerning the sales force expansion and R&D expenses. He also questioned whether MACI Arthro surgeon growth for 2026 is anticipated to be driven more by new surgeons or repeat surgeons.

Answer

Joe Mara, Vericel's Chief Financial Officer, stated that total OpEx for 2026 is guided at approximately $220 million, with incremental costs including roughly $10 million annually for the 30-person sales force expansion and increased R&D for the MACI Ankle MASCOT clinical trial. Nick Colangelo, Vericel's President and Chief Executive Officer, emphasized leveraging the expanded sales force and MACI Arthro to increase reach, drive deeper penetration with existing surgeons, and continue training new surgeons, focusing on achieving depth within practices.

Jeffrey Cohen requested an update on the patent case with Natus, including its current phase and expected impact on 2026 expenses. He also inquired about the LVO stroke indication, specifically its call point beyond the ICU and whether it involves neuro or cardiac specialists.

Answer

CEO Jane Chao stated the patent case is in the discovery phase, with a preliminary decision expected on November 19th, and milestones publicly available. CFO Scott Blumberg anticipates increased expenses in Q1/Q2 2026 during the core of the case, moderating in Q3/Q4. Jane Chao explained that LVO monitoring targets inpatients, many in the ICU, maintaining the same call point, but also addresses stroke patients outside the ICU. She confirmed neurologists, particularly stroke neurologists, would be involved.

Jeffrey Cohen requested an update on the patent case with Natus, including its current phase and ramifications for 2026 expenses. He also asked about the LVO stroke indication, specifically its call point beyond the ICU and whether neuro and/or cardiac specialists would be involved.

Answer

Jane Chao, Co-founder and Chief Executive Officer, stated that the patent case is in the discovery phase, with a preliminary decision point on November 19th, and the timeline is publicly available. Scott Blumberg, Chief Financial Officer, noted that litigation expenses have been relatively linear since Q3 last year but are expected to increase in Q1 and Q2 2026 before potentially moderating. Jane Chao explained that LVO monitoring focuses on inpatients, many in the ICU, making it the same call point. She added that stroke neurologists would definitely be involved, and the technology would be synergistic with seizure and delirium monitoring, especially for patients on the floor or in telemetry units with less trained bedside nursing.

Jeffrey Cohen inquired about the expected cadence of R&D expenses throughout 2026, seeking clarification on whether investments would be consistent or lumpy across quarters. He also asked about Beta Bionics' pricing plans for the DME channel in 2026, following a low single-digit price increase in the pharmacy channel.

Answer

Sean Saint, CEO, stated that R&D investments are generally expected to be consistent throughout 2026, with potential lumpiness around trial starts but no significant weighting in any particular quarter. He confirmed a low single-digit price increase for supply revenue in the pharmacy channel and no expected change to DME revenue pricing for 2026.

Jeffrey Cohen asked for insights into the expected cadence of R&D expenses throughout 2026. Jeffrey Cohen also inquired about Beta Bionics' pricing plans for 2026, specifically the low single-digit increase in the pharmacy channel and expectations for DME channel pricing.

Answer

CEO Sean Saint indicated that R&D investments are generally expected to be consistent throughout 2026, with potential lumpiness around trial initiations, but no significant weighting towards any particular quarter. CFO Stephen Feider confirmed a low single-digit price increase for supplies sold through the pharmacy channel and stated that no change should be modeled for DME revenue price.

Jeffrey Cohen inquired about the commercial progress of the OneRF trigeminal nerve ablation system, specifically the number of centers and physicians involved in the nine reported cases, and the level of strategic interest from Zimmer Biomet or other potential partners. He also asked for clarity on Zimmer Biomet's domestic presence regarding the OneRF brain ablation system and sought guidance on the expected trajectory of operating expenses for the remainder of fiscal year 2026, particularly for R&D and SG&A.

Answer

CEO Dave Rosa confirmed that the nine trigeminal nerve ablation cases were performed at three centers, with all patients reporting pain relief, highlighting the system's single-placement advantage. He noted ongoing diligence discussions with a strategic partner for licensing, while also preparing for independent commercialization if necessary. Regarding Zimmer Biomet's domestic presence, Mr. Rosa stated that NeuroOne does not have specific data on the number of centers or physicians, only that Q1 fiscal 2026 saw nearly half of all ablations since launch. CFO Ron McClurg indicated that SG&A expenses are expected to remain relatively flat, but R&D expenses may fluctuate due to project phases, including an acceleration in the drug delivery program and upcoming animal studies for spinal cord and drug delivery in Q2 and Q3.

Jeffrey Cohen inquired about the OneRF trigeminal nerve ablation system, specifically the number of centers and physicians involved in the nine reported cases, and the level of strategic interest from Zimmer Biomet or other potential partners. He also asked for clarity on Zimmer Biomet's domestic presence for the OneRF brain ablation system and NeuroOne's expectations for operating expenses, particularly R&D fluctuations, for the remainder of the fiscal year.

Answer

CEO Dave Rosa confirmed that the nine trigeminal nerve ablation cases were performed at three centers, with all patients reporting pain relief, highlighting the device's single-placement advantage. He noted ongoing diligence discussions with a strategic partner for this technology, with readiness to commercialize independently if needed. Regarding Zimmer Biomet's OneRF brain ablation system, Mr. Rosa stated that NeuroOne does not have specific data on the number of centers or physicians, but Zimmer Biomet reported that nearly half of all ablations since launch occurred in Q1 fiscal 2026. CFO Ron McClurg added that SG&A is expected to remain flat, while R&D may fluctuate due to accelerated projects like drug delivery and upcoming animal studies for drug delivery and spinal cord programs in Q2 and Q3.

The analyst asked about the development status of the drug delivery platform, the market opportunity for trigeminal ablation, the product design for spinal cord stimulation (SCS), and the financial outlook for Q4 and fiscal 2026.

Answer

The company stated that the drug delivery platform is currently in bench and animal testing phases. The trigeminal ablation market targets about 150,000 US patients and will be commercialized through existing neurosurgeon relationships. The SCS product for lower back pain will have multiple SKUs and is a stimulation, not ablation, device. Management reiterated fiscal 2025 guidance but did not provide a forecast for 2026, citing confidence based on their contract with Zimmer Biomet.

Jeffrey Cohen from Ladenburg Thalmann asked about Legacy Education's M&A strategy, specifically regarding geographic expansion outside California and target acquisition size, the nature and student commitment for hybrid programs, the expected financial cadence for the back half of the fiscal year, and factors influencing higher revenue per student.

Answer

CEO LeeAnn Rohmann confirmed looking at multi-campus opportunities both within and outside California, emphasizing that hybrid programs require full-time commitment but offer flexibility, attracting a different student demographic. She indicated alignment with analyst models for the back half of the year, with potential upside from new program rollouts. CFO Brandon Pope clarified that higher revenue per student was partly due to the prior year's acquisition timing and increased starts in higher-margin, longer programs.

Jeffrey Cohen asked about Legacy Education's M&A strategy, specifically if targets are outside California and if they are similar in size to current facilities. He also inquired about the commitment level of students in hybrid programs, sought commentary on the fiscal second half's cadence compared to the previous year, and asked if the higher revenue per student was due to more expensive programs or operational leverage from the hybrid model.

Answer

CEO LeeAnn Rohmann confirmed that Legacy Education is evaluating multi-campus acquisition opportunities both within and outside California, including adjacent states. She explained that hybrid programs require a full-time commitment, combining online theory with a few days a week on campus for labs, offering flexibility that attracts a different type of student. Rohmann indicated that the company's performance aligns with analyst models, with potential upside from new program rollouts in Q3 and Q4. CFO Brandon Pope clarified that the higher revenue per student in Q2 fiscal 2026 was primarily due to revenue recognition from a student population that had no corresponding revenue in Q2 fiscal 2025, and also noted that more starts in higher-margin, longer programs contribute to a quicker earning pace.

Asked for clarification on Q4 guidance considering historical trends, details about the EMT program rollout, whether the company offers neurology programs, and the status of M&A activity.

Answer

Management explained that Q4 would likely see typical seasonality due to student starts being pulled into Q3. They detailed the current status and expansion plans for the EMT program, confirmed no current neurology offerings, and reiterated they would provide updates on M&A when appropriate.

Jeffrey Cohen asked about the projected operating expenses over the next four to six quarters, the customer base and cross-selling opportunities from the VasoHealthcare IT acquisition, and a clarification on the previously stated EBITDA break-even targets for 2026 and 2027.

Answer

CEO Erez Meltzer indicated increased sales and marketing, tamed R&D, and stable G&A. He detailed VasoHealthcare IT's medical-related customer base (hospitals, imaging centers) and the cross-selling potential for Nano-X AI solutions, ARC systems, and teleradiology services. Both CEO Meltzer and CFO Ran Daniel reiterated that the AI business aims for quarterly EBITDA break-even in 2026, and the overall company targets EBITDA break-even in 2027.

Jeffrey Cohen inquired about the projected operating expenses over the next four to six quarters in relation to 2026 targets, the customer profile of VasoHealthcare IT and cross-selling opportunities, and sought clarification on the previously stated EBITDA break-even timelines for the AI business and the company as a whole.

Answer

CEO Erez Meltzer explained that sales and marketing expenses would increase, R&D would be more contained, and G&A would remain stable. Regarding VasoHealthcare IT, Erez Meltzer noted its 100 medical-related customers (hospitals, imaging centers) offer significant cross-selling opportunities for Nanox.AI, ARC systems, and teleradiology services. Both Erez Meltzer and CFO Ran Daniel reiterated that the AI business aims for quarterly EBITDA break-even in 2026, with the ARC division targeting break-even in 2027, leading to overall company break-even in 2027.

Jeffrey Cohen with Ladenburg Thalmann inquired about the current adoption and future expectations for the accelerated Deep TMS protocol for MDD, the pipeline and anticipated pace of minority equity investments, and the regulatory and commercial timing for Neurolief in the U.S., Japan, and EU.

Answer

CEO Hadar Levy detailed that the accelerated protocol, reducing treatment to six days with five sessions daily, is seeing good demand and is a key growth driver. Regarding minority investments, Mr. Levy confirmed a robust pipeline, with plans to complete at least one more by year-end 2025 and several opportunities for 2026, contingent on due diligence. For Neurolief, Mr. Levy stated the company anticipates FDA clearance by the end of 2025, which would enable distribution through various channels including VA, IDM, and BrainsWay customers.

Jeffrey Cohen asked about the current adoption and future expectations for the accelerated Deep TMS protocol, the pipeline and outlook for minority equity investments, and an update on Neurolief's regulatory and market activities in Japan, EU, and the U.S.

Answer

CEO Hadar Levy noted strong demand for the accelerated protocol, which shortens the acute treatment phase to six days, and a robust pipeline for minority investments with a goal for at least one more by year-end 2025. He also mentioned anticipating Neurolief's FDA clearance by year-end 2025 for U.S. distribution.

Asked for guidance on the international business for the second half of the year and for detailed information about the ongoing lawsuit against LaserOptik, including potential damages, costs, and the number of competitor units placed.

Answer

The company expects the second half's international business to be similar to the prior year but cautions that tariffs create significant uncertainty. Regarding the lawsuit, damages are estimated in the eight-digit range due to LaserOptik's false advertising and misleading claims. Most legal expenses are in the past, but the case will be extended slightly by the addition of new defendants. The exact number of competitor units placed is unknown due to legal tactics by the defendant.

Asked about the revenue breakdown for Truvega SKUs, the status and costs of patent infringement litigation, and clarification on new products expected in the third quarter.

Answer

The company stated that the higher-priced Truvega Plus accounts for about 80% of its category revenue. Regarding legal matters, cross-complaints have been filed in federal court, with some costs incurred in Q1 and Q2, but no further details were provided. The 'new product' launch refers to the prescription Quell Fibromyalgia, which is now in production and expected to generate revenue in the second half of the year.

Asked for details on the company's user base and its expansion, and for clarification on whether the 2025 guidance includes M&A and how customer attrition/addition is factored in.

Answer

The user base is geographically and specialty-diversified, with growth opportunities in upselling digital health, RCM, and AI solutions. The 2025 guidance is based on organic growth and small tuck-ins, not material M&A, and accounts for natural customer attrition which must be replaced before net growth is achieved.

Inquired about the timeline for the Quebec order deliveries, the company's expected commercial structure by year-end (personnel, centers), and the anticipated number of physical therapists to be trained in 2024.

Answer

The Quebec order is expected to progress through Q2 and Q3 as sites are brought under contract, with deliveries following. The company plans a highly leverageable commercial model using partners, e-commerce, and online training rather than a large internal team. They are not yet providing specific metrics on trained physical therapists but may do so in the future after reimbursement is established.

Asked about the company's plans for cash utilization in upcoming quarters, the outlook for gross margins for the remainder of fiscal 2024, and the impact of the disciplined SG&A spending.

Answer

The company explained that recent cash use was for reducing payables and funding inventory. They are not providing specific margin guidance but suggested Q1's margin is likely at the higher end for the year. The leaner SG&A structure is expected to provide operating leverage as revenue grows.

Inquired about the terms of the new line of credit, the outlook for customer channels and shifts in fiscal 2024, expected revenue seasonality, and margin expectations for the upcoming year.

Answer

The company explained the line of credit is a $7.5M asset-based facility with an interest rate around 11%. The customer base and channels are expected to remain consistent. Revenue seasonality should follow historical patterns, with Q1 and Q4 being stronger. While SG&A is guided to be lower (29-33% of sales), the company is not providing gross margin guidance at this time due to recent operational changes and revenue disruptions.

Jeffrey Cohen of Ladenburg Thalmann inquired about the outlook for gross margins for the remainder of 2020 and into 2021, the company's facility footprint post-consolidation, any expected revenue from COVID-19 testing, and the anticipated business mix between clinical and pharma services.

Answer

Executive Jack Stover explained that gross margins are expected to improve due to the consolidation of pharma services labs from Rutherford, NJ, to a single, lower-cost facility in North Carolina, which will reduce fixed overhead. He also noted potential price increases for ThyraMIR and ongoing cost reductions. Regarding the business mix, CFO Fred Knechtel stated that while pharma services represented 55% of revenue in Q2, they expect the mix to return to the historical 60% diagnostics and 40% pharma as the clinical business recovers. Stover added that they do not anticipate significant revenue from COVID-19 testing in the back half of the year.

Jeffrey Cohen of Ladenburg Thalmann inquired about the operating expense outlook for Q2 and the remainder of the year, its correlation with gross margins, current trends in test origination and patient visits, and sought clarification on the $2.1 million Medicare advance payment.

Answer

CFO Fred Knechtel detailed the OpEx reduction plan, noting Q1's expense was $9.2M, down from $9.5M in Q4 2019. He projected a further 10% reduction in Q3, with costs managed closely based on volume. President and CEO Jack Stover added that while business is recovering, there is a 30-60 day lag in impact, and they are cautiously optimistic. Stover and Knechtel clarified the $2.1M Medicare payment was an advance on future billings based on past volume, intended to offset pandemic-related cash flow decreases, and was included in the reported cash balance.

Jeffrey Cohen of Ladenburg Thalmann inquired about the reconciliation of the $3.5 million and $5.2 million receivable reserves, clarification on cash and availability figures, the amount of the planned PPP loan application, and broader commentary on margin outlook and April volume trends.

Answer

Executive Jack Stover and CFO Fred Knechtel clarified the accounting for the receivable reserves under ASC 606, explaining they relate to prior period billings and any future collections will be recognized as 2020 revenue. They detailed that the cash and availability figure includes cash on hand plus borrowing capacity under their credit facility. They confirmed a $3.5 million PPP loan application. Regarding margins, they noted the diagnostics business runs at over 50% gross margin while the newer pharma business is in the low 30s with significant upside potential. They also observed encouraging signs of volume recovery in April after a March decline.

Jeffrey Cohen of Ladenburg Thalmann inquired about the projected timeline for the NDA filing and commercial launch, the final patient enrollment target for the LEVO-CTS trial, and the expected financial modeling for 2017, including R&D/G&A split and milestone payments. He also asked for clarification on the updated cardiac surgery market size and sought retrospective insights into the failed LeoPARDS sepsis trial.

Answer

CEO John Kelley projected a commercial launch in the first half of 2018, confirmed the target enrollment is 880 patients, and sourced the market size data to the Society of Thoracic Surgeons. CFO Michael Jebsen detailed a more even G&A/R&D split for 2017, a $2 million milestone payment to Orion upon US approval under G&A, and an estimated Canadian approval nine months post-US. Kelley also analyzed the LeoPARDS trial, suggesting it failed due to the wrong patient population (potentially hypotensive) and a high dosing regimen.

Jeffrey Cohen of Ladenburg Thalmann inquired about the LEVO-CTS trial, specifically why some randomized patients didn't receive the drug. He also sought clarification on the 2016 R&D expense forecast and asked about the potential structure of a North American commercial organization for levosimendan.

Answer

CEO John Kelley explained that patients might not receive the study drug due to changes in clinical status or withdrawn consent post-randomization. CFO Michael Jebsen confirmed the full-year 2016 R&D forecast is now $13M-$13.5M, reflecting an additional $2.5M for expanded trial enrollment. Kelley also outlined a potential 70-75 person commercial team to target key hospitals in the U.S. and noted that a direct approach in Canada is being considered.

Jeffrey Cohen of Ladenburg Thalmann & Co., Inc. asked about the rationale for extending the LEVO-CTS trial, the concentration of top recruiting sites, the mathematical benefit of forgoing a statistical penalty, the projected R&D spending curve for 2016, and potential business development activities.

Answer

CEO John Kelley explained that the LEVO-CTS trial is being extended by about a month to over-enroll and compensate for patients with incomplete data, costing an additional $0.5 million. He detailed top recruiting sites like Tacoma and Cleveland Clinic and noted that forgoing the second interim analysis provides a minor statistical benefit but was primarily driven by the rapid enrollment pace. Kelley also confirmed the company is evaluating other drug opportunities. CFO Michael Jebsen added that the accelerated enrollment will front-load R&D expenses into the first half of 2016, with costs tapering off in Q3 and Q4.

Jeff Cohen of Ladenburg Thalmann inquired about the commercial status of Amedica's porous structure in Europe, the details and data timeline for the SNAP clinical trial, and the current status of the dialogue with the FDA regarding the porous product.

Answer

CFO Ty Lombardi stated that sales of the porous structure in Europe are currently limited due to a small distribution channel. Chairman and CEO Dr. Sonny Bal explained that the SNAP trial, a 100-participant randomized trial comparing silicon nitride to PEEK in lumbar fusion, has shown excellent preliminary 12-month results, with a manuscript planned for submission by year-end. Regarding the FDA, Dr. Bal confirmed they have answered all questions with statistical proof, the dialogue is ongoing and collegial, and they recently received a 180-day extension to finalize labeling and indications.

Jeffrey Cohen of Ladenburg Thalmann inquired about several key areas: the specifics of the FDA's request for further data on the cervical fusion device, projections for the Q2 balance sheet, details on the company's new 3D printing capabilities for silicon nitride, clarification on a geographically weak sales region, and specifics on the new metal screw fixation system planned for launch.

Answer

Chairman and CEO Dr. Sonny Bal explained that the FDA's questions pertained to subgroup statistical analysis at earlier time points for the cervical level study, not the final 24-month endpoint, and expressed confidence in the upcoming submission. CFO Ty Lombardi projected that by the end of Q2, cash would be around $5 million and debt near $12 million. Dr. Bal also detailed their success with Robocasting for 3D printing silicon nitride. Regarding sales, management acknowledged a weak geography but noted a new individual is in place to stabilize it. They also described the upcoming pedicle screw system, highlighting its modular, cannulated design for a limited launch late in the year.