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CFO John Bates stated the company is working to complete the restatement within the 60-day Nasdaq compliance window. He detailed the IDR process, noting a win rate of over 85% and a collection rate of over 75%, with revenue being accrued at that collection rate. CEO Dr. Tom Vo confirmed two new hospitals are set to open in 2025, with a third being possible, and explained that growth at mature hospitals is being driven by increasing higher-acuity inpatient and observation stays.

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CFO Jon Bates confirmed that IDR-related revenue will be recognized progressively each month in 2025. Chairman and CEO Dr. Tom Vo stated that of the four new hospitals, two are performing above expectations and two are on track. He outlined plans for three new hospitals in late 2025 and a pipeline for 2026-2028. For mature hospitals, he targets single-digit ER volume growth plus increased admissions. Dr. Vo also expressed hope that their 80% IDR win rate will incentivize insurers to pay more fairly upfront to avoid the costly process, but noted it is still too early to confirm this trend.

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Chairman & CEO Jim Kras and Interim CFO Kostas Dafoulas explained that the private label segment is a growing, high-priority area with lower marketing costs and contracted revenue, noting a 19% year-over-year increase in dollar sales. Kostas Dafoulas attributed the additional revenue gap to softness in condiments and a temporary dip in the vitamin segment during the transition to the new Kick Sports Nutrition line. Jim Kras detailed that the Natural Shrimp acquisition (now Edible Garden Prairie Hills) provides a key Midwest distribution hub, a valuable patent portfolio for water treatment, and a facility for R&D and future production of high-margin nutraceuticals.

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Executive James Kras explained that the Natural Shrimp facility will immediately provide needed warehousing space in the Midwest, supporting expansion with major retailers and housing refrigerated products. He highlighted the R&D potential for developing new nutraceutical ingredients from shrimp, leveraging existing patents. Kras noted that while Natural Shrimp's current revenue is nominal, margin accretion will come quickly from logistics savings and leveraging the facility, rather than its existing sales. Regarding the sports nutrition line, Kras stated he was 'ecstatic' about its performance, citing new distribution with a major big-box retailer that shipped in Q2 and other significant launches planned for the near term.

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Interim CFO Kostas Dafoulas and CEO James Kras clarified that Q4 margins were impacted by a planned labor ramp-up for the holiday season, not inventory write-offs. Kras detailed the Orion acquisition's strategic benefits, including cross-selling coconut and superfood products in the U.S. and leveraging Orion's EBITDA-positive status. He also outlined the Amazon-exclusive launch and upcoming retail rollout for the 'Kick' sports nutrition line. Both executives confirmed no further one-time charges are expected from exiting the lettuce and floral categories.

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James Kras, an executive, explained that the company has sufficient capacity for Q4 demand due to investments in vertical integration and new production lines, eliminating the need for contract growers. He quantified the hurricane impact as a $215,000 revenue shift from Q3 to Q4. Regarding the new 'Kick' sports nutrition line, Kras expressed strong confidence, citing his industry experience and upcoming launches with major partners. He also confirmed that gross margins are expected to continue expanding as the company has fully exited the non-core, low-margin floral business and optimized its lettuce category, allowing for a greater focus on its core food products.

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CEO Eyal Shamir confirmed that all requested information for the post-market study has been submitted and that FDA leadership is actively engaged in the process. He noted the company is lining up commercial and study sites, with physicians eager to participate. Shamir highlighted growing interest in Europe, driven by strong data and upcoming presentations at major conferences like CIRSE. He affirmed that a US FDA approval would be a significant catalyst for sales acceleration in Europe and Japan.

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The company confirmed the post-market study will involve 400 patients at over 25 sites with a 3-year recruitment period, but the FDA has not provided a specific response timeline. They see potential to increase reimbursement by moving from a CPT3 to a CPT1 code post-authorization. The Japanese market is significant, with over 100,000 new cases annually, and the approval there is expected to be less restrictive than the initial US one.

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CEO Eyal Shamir confirmed the post-market study will involve 400 patients at over 25 sites, with an estimated three-year recruitment period. While the FDA has not provided a specific review timeline, top management is involved. Shamir detailed a two-part reimbursement strategy: increasing the CPT-3 code value through claims data and applying for a CPT-1 code post-authorization. He also sized the Japanese market at over 100,000 new breast cancer cases annually, with partner Terumo expecting fewer patient limitations than the initial U.S. indication.

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Executive Ronen Tsimerman confirmed the company expects an FDA decision in Q1 2025 but has no exact date. Regarding Japan, he stated Terumo plans to file in 2025, with close assistance from IceCure. Executive Shay Levav clarified the Japanese approval process is expected to take approximately one year from submission. On the kidney cancer indication, Ronen Tsimerman announced that interim results from the ICESECRET trial are expected in early December 2024 and noted the U.S. market represents about 80,000 new patients annually, though breast cancer remains the top priority.

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Chairman & CEO Lishan Aklog reiterated that the draft LCD is the key milestone, as it allows for retroactive billing for up to one year once the final policy is issued. He confirmed a final decision in early 2026 is a reasonable expectation if a draft is issued by the end of 2025. Regarding commercial payers, Dr. Aklog described the pipeline as robust, stating the Highmark policy has served as a powerful precedent in accelerating discussions with other regional and national plans, some of which may not wait for the final Medicare decision. CFO Dennis McGrath added that state-level biomarker legislation often ties coverage to a Medicare LCD, which will provide another tailwind.

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CEO Dr. Lishan Aklog reported dozens of active conversations with commercial payers and noted that the new concierge medicine channel has shown surprisingly rapid progress, with over 20 contracts signed in just a few weeks. CFO Dennis McGrath added that these new cash-pay and direct-contracting channels are key to the strategy of cutting the cash burn rate, providing financial stability alongside the traditional reimbursement journey.

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CEO Dr. Lishan Aklog expressed optimism for a Medicare coverage decision in the first half of the next year, citing deep engagement with MolDx and a strong data package. He reiterated that concierge pricing is a direct negotiation with practices for cash-paying patients, starting from a $2,500 list price, and is independent of the insurance reimbursement process.

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Chairman and CEO Lishan Aklog reiterated that the draft LCD is the key milestone and hoped for its publication before the end of 2025, which would likely place a final decision in 2026. He highlighted the one-year look-back for billing Medicare claims. Regarding commercial payers, Aklog stated that the full data package and the Highmark precedent have accelerated discussions, and he expects a meaningful subset of regional plans will grant coverage without waiting for a final Medicare decision. President & CFO Dennis McGrath added that state-level biomarker legislation will also be a positive catalyst.

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Dr. Lishan Aklog, Chairman and CEO, stated that the Veris 510(k) submission might be slightly delayed into the second half of 2025 due to the recent corporate restructuring. He also clarified that for PortIO, a term sheet is in place with an angel network to raise $4 million, and the diligence process is nearly complete.

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CEO Ilan Sobel detailed several process innovations, including digitization of biological metrics to optimize yield, automation of harvesting and drying, and the development of next-generation 2,000+ liter bioreactors. He highlighted the growing role of AI and computational biology in the CDMO business. For Q3, Sobel noted the initial rollout of the HealthPros program and the launch of the hydration product, clarifying that the most significant financial acceleration from these initiatives is expected in Q4.

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The CEO described ongoing process optimization through digitization, automation of harvesting/drying, and development of next-generation 2,000-liter bioreactors for the next facility. AI and computational biology are key competitive advantages for the CDMO business. For Q3, key activities include onboarding the first HealthPros and preparing for the October hydration product launch, with the true financial impact of these initiatives expected in Q4.

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The company confirmed its large customer has paused but remains committed, and they expect a rush of orders once there's clarity. The pause could impact Q3, but the timing of a resolution is unknown. They are optimistic about international growth beyond China, thanks to the new MD SAP certification. They reiterated their belief that the LCD issue will be resolved favorably due to strong clinical evidence and lobbying, and highlighted the separate, positive development of the proposed physician fee schedule which significantly increases the SRT delivery code reimbursement.

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CEO Joseph Sardano confirmed that customers, including their large partner, have paused orders pending clarity but remain committed to IGSRT, which could lead to a rush of deliveries upon resolution. President Michael Sardano expressed high confidence in defeating the LCD proposal, citing overwhelming clinical evidence supporting image-guided SRT, including an NIH study. Joseph Sardano also noted that the new MD SAP certification opens significant new international markets beyond China, which could provide an offset.

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Platinum insisted the agreement cover all 130 sites, with installations happening over time. Sensus is in talks with several other large PE-backed groups. The Fair Deal agreement is not offered internationally, where the company uses distributors. The strong Q3 was driven by existing agreements and sales, not the Platinum deal, and still showed some seasonality compared to Q2.

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CEO & CFO James Frakes stated that enrolling more than one patient per month in India is "very possible" due to the population size, though recruitment remains the key variable. Regarding grants, he noted the company would only pursue opportunities that align with its core goals. Frakes confirmed that operating expenses are now at a baseline, stating "that is where we are," and noted that costs might increase slightly as clinical trial activity ramps up.

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Chief Medical Officer Dr. Steven LaRosa confirmed the third site would be activated within days, which, combined with the amended protocol, should accelerate patient enrollment. On bird flu, he stated that while the company is monitoring the situation, the Hemopurifier has not been used in humans for this indication and would not be a first-line treatment. CEO and CFO James Frakes explained that the $1.8 million operating expense is not a fixed run rate and is expected to increase as clinical trial activities ramp up.

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CEO Adam L. Michaels reported good progress with Walmart, including expanding doors, and active discussions with Kroger and Target. He confirmed the trade spend was a catalyst for volume and branding opportunities that boosted ROI. Surprisingly, Michaels revealed that the total SKU count has been reduced by over 50% since he started, as the company eliminated unprofitable items to focus on a more strategic product portfolio for channels like C-stores.

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CEO Adam Michaels attributed the revenue strength to a balanced performance across the portfolio, including strong results from all three club customers, growth at retailers like Albertsons, new items at BJ's, and promising reorders from Walmart. He explained that the Northeast revenue decline was 100% attributable to an intentional pullback from unprofitable legacy 'Street business' from a prior acquisition, emphasizing that core Northeast retail customers are growing.

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CEO Paul Gudonis explained that the O&P channel initiative, including in-depth certification classes, enables clinicians to build their own patient pipelines and manage reimbursement, which is expected to accelerate revenue in the second half of the year. He also reported that lives under contract or pending have increased from 18 million to 25 million, primarily with state Blue Cross Blue Shield plans, and that discussions with national plans are ongoing. He clarified they do not typically engage directly with employers.

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CFO Dave Henry reported the cost per pipeline add was $1,226. CEO Paul Gudonis explained that while the historical success rate on appeals was 40-50%, this has recently decreased and timelines have lengthened. He also detailed the physician education process. Dave Henry clarified that 2025 CapEx is expected to be low, around $1 million or less, as the major facility move is complete.

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CFO David Henry estimated the net value of the 316-unit backlog at over $10 million, which CEO Paul Gudonis added is typically realized over 3-6 months. Gudonis clarified they have about a dozen clinicians for their direct business and two business development reps for the O&P channel. The international focus remains on Germany, with other markets being longer-term projects, while the China JV is expected to generate revenue in 2025. Gudonis also noted that MyoPro enhancements are planned for a Q1 2025 announcement.

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CFO David Henry explained that the authorization rate is already improving, reaching about 19% in Q2, driven by faster-moving Medicare Part B patients who don't require the same reimbursement hurdles as Medicare Advantage patients. He acknowledged that increased marketing spend could impact the Q4 operating cash flow breakeven goal but stated the investment is necessary to ensure continued revenue growth momentum into 2025 and minimize seasonality.

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Chair of the Board Dawn Zier declined to comment on past leadership, attributing changes to a dynamic business environment. CFO Lee Boyce admitted the company had 'missed the ball a little bit' on pricing execution and is now 'turbocharging' its revenue growth management (RGM) capabilities. Interim CEO Alison Lewis added that the performance issues are concentrated in North American Snacks, allowing for a focused approach to fixing them.

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CEO Wendy Davidson expressed high confidence in the Baby, Beverage, and Meal Prep categories. She noted she is more cautious on Snacks, where improved marketing productivity is needed, and stated this risk is factored into the guidance. Regarding Personal Care, she confirmed the strategic review process began in Q2 with a bank engaged, and the goal is to execute a transaction within the fiscal year, while continuing to operate the business effectively.

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Wendy Davidson, President and CEO, stated that Earth's Best formula is a key, margin-accretive growth driver. She confirmed that supply has returned for all formulations and will be available in all sizes by the end of Q2. Redundancies have been built in through increased inventory and qualifying a manufacturing partner to produce in more than one location. She noted that where distribution has been regained, velocities are at or exceeding historical levels. On leverage, CFO Lee Boyce confirmed the focus is on using organic cash flow from EBITDA growth and working capital initiatives to pay down debt, noting a reduction of over $90 million since Q1 of the prior year. Davidson added that there were no new divestitures to announce at this time.

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Executive Riccardo Delle Coste confirmed that the co-manufacturer onboarding is on track for completion by the end of Q2 2025, with some equipment already live. He noted that the bidding process for the next school year has begun, with awards expected over the next few months. Delle Coste also mentioned that while not universal, a number of bids include the new Pop & Go product. He affirmed that the company has sufficient inventory and is appropriately staffed to meet projected demand.

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Executive Riccardo Delle Coste explained that initial Pop & Go orders have just shipped for Q4 revenue, with high customer interest driven by a lunch menu opportunity up to 5x larger than breakfast. He clarified that a different co-manufacturer produces Pop & Go, which has a margin profile similar to or slightly better than Twist & Go. The company is currently in about 6,000 schools (~4.5% penetration) with its breakfast products but was previously capacity-constrained. CFO Lisa Roger added that manufacturing expansion covers all product lines.

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Steven Foster, an executive, explained that while Tenon Medical doesn't control the reimbursement environment, they are actively working to bring clarity and have seen great progress, though the process remains slow. Regarding the sales force, Foster confirmed that building the team was a key mission in 2024. The company now has 6 direct regional sales managers who are all in place, overseeing 42 independent distributor contracts.

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Steven Foster, an executive at Tenon Medical, explained that reimbursement issues were due to transient, regional coding confusion, which he expects to resolve with upcoming AMA clarity. He noted that the company's new clinical data reinforces the Catamaran system's safety and efficacy for payers, which, combined with coding clarity, should improve coverage. Foster also confirmed that physician feedback directly led to the development of the smaller Catamaran SE system to provide more options. Finally, he stated that the sales force expansion is actively underway and will continue over the coming months.

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Executives confirmed the revenue guidance conservatively assumes the complete departure of the largest customer by June 30, with any new agreement constituting upside. They noted that the gross margin guidance reflects spreading fixed costs over a lower revenue base, not pricing pressure, as the lost customer was a low-margin account. Growth opportunities on the West Coast and internationally are being actively pursued.

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Executive Jake Singleton explained that 2025 is a transition year, making a GAAP revenue guide difficult. He clarified that the approximately $70 million in corporate clinic revenue would convert to a franchise royalty structure of roughly 10-10.5%. While declining to provide a specific forward guide on G&A reduction, he stressed that rightsizing G&A post-refranchising is a critical focus for management to make the business more profitable than it was under the mixed-ownership model.

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Executive John Erb explained that he does not see a need for immediate, significant changes, as the team is effective. He highlighted the recent JACC Heart Failure publication and the new outpatient reimbursement as key strategic drivers for the sales team. He confirmed that an executive search firm has been hired and is actively working on the CEO search, and he has already passed along potential candidates.

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Executive Nestor Jaramillo stated that the company is preparing by identifying and supporting hospitals that previously performed outpatient ultrafiltration, helping them with setup and ensuring payer coverage is in place. He confirmed that the current field team of nine territories is sufficient to launch this initiative without immediate new hires, though the company may add reimbursement expertise at its headquarters.

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Executive Nestor Jaramillo reported that Nuwellis added one new pediatric account in Q2, bringing the total to 41. He confirmed the REVERSE-HF trial is on track to complete enrollment by Q3 2025, with over a third of patients already enrolled. Regarding the SeaStar partnership, Jaramillo clarified that SeaStar handles the required IRB approvals and patient registry, while Nuwellis manages all commercial activities, including training, sales, delivery, and clinical support. He also noted a controlled, limited launch strategy for QUELimmune, targeting 10 hospitals by year-end.

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The inventory charge was primarily a new reserve for refurbished AviClear units. R&D is focused on indication expansion for existing products like AviClear. The company expects a 50% reduction in cash burn in 2025, driven by working capital improvements. Key geographic opportunities include Korea and Japan, with China as a long-term prospect. Over half of the leased AviClear units are expected to be returned, and the company is now focusing on driving utilization in a core group of committed accounts.

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The manufacturing transition from Jabil is already complete from a production standpoint; the main remaining task is bringing back inventory. International sales as a percentage of total revenue will decrease in 2024 because the Japan-exclusive skincare business has been discontinued. The international sales model of using both direct sales in major markets and distributors elsewhere will remain largely the same.

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Executive Jan Haverhals clarified that the Medicare Administrative Contractor (MAC) coverage applies to Florida, New Jersey, and Texas, representing one-third of U.S. epidural procedures. He stated the physician payment rate is $325, in addition to the primary procedure code. Haverhals detailed the commercialization strategy, which involves a partnership with Actual Biologics to target large institutions, and noted the official rollout had just begun. Regarding claims, he mentioned nearly 200 were submitted prior to the new pricing structure, and the focus is now on transitioning clinicians to new sales agreements. For the Dental division, Haverhals confirmed a Q2 shipment of approximately $250,000 was delayed but expects sales to improve in the second half of the year, noting July was a strong month.

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Executive Jan Haverhals clarified that 60 of the 160 claims were submitted between January and May 2024, adding to the 100 from 2023. He emphasized a focused approach on a select group of clinics to ensure high-quality submissions and noted that some commercial payers have already paid for the procedure. Haverhals explained that cash flow from the profitable dental business is funding the medical segment's development, which hinges on securing reimbursement. For the international dental business, he stated the focus is on optimizing existing distributor relationships rather than restarting, and there are no current plans for an international e-commerce platform.

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Executive Dane Andreeff confirmed that Helius has a strong, pre-existing list of Medicare patients ready for PoNS therapy upon CMS reimbursement approval. He affirmed that the stroke trial enrollment is on track for an FDA submission in the first half of 2025, leveraging their breakthrough designation. Regarding TBI, Andreeff mentioned they are still investigating expansion, citing a positive cost-benefit analysis from a prior Pacific Blue Cross study which showed significant savings and patient improvement.

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Executive Dane Andreeff confirmed that Helius Medical Technologies has a substantial list of Medicare patients ready to proceed once reimbursement is established. He stated that the stroke trial enrollment and the subsequent FDA submission remain on track for the first half of 2025, leveraging their breakthrough designation. Regarding TBI, Andreeff highlighted a Canadian white paper from Pacific Blue Cross which showed significant cost-benefit and positive outcomes for patients using PoNS Therapy, indicating a strong case for its use in that indication.

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The PoNS step trial is fully enrolled with 6 sites, and no more will be added in 2024; results are expected in Q3 and Q4. The recent APTA conference was very successful, generating significant inquiries, with a notable increase in interest from VA rehab specialists for treating MS, TBI, and stroke patients.

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CFO Dick Akright clarified the backlog is 76% CEA-related and 24% commercial. CEO Bradley Nattrass stated that the removal of tax burden 280E is the largest benefit of rescheduling, which he believes is separate from banking reform. Both executives confirmed the company is now 'right-sized' after its cost-cutting efforts, with an expected $8 million in G&A savings in 2024, and no further significant reductions are planned.

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The key cannabis market inflection point is federal rescheduling, but the company's performance is more dependent on state-level license awards. The international focus is on the Netherlands, UK, and Germany for both cannabis and vertical farming. M&A is not a near-term priority; the focus is on organic growth and achieving positive cash flow.

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CEO Michael Feldschuh detailed the dual 510(k)/CLIA waiver application process, targeting a second-half 2023 launch. He noted that FDA regulations prevent them from marketing the unapproved device to clients. He highlighted a 59.5% increase in kit sales as a key usage metric and the opening of 18 new accounts in 2022. Regarding the reporting status, both CEO Michael Feldschuh and CFO Robert Michel explained they are now addressing the transition with the SEC but noted the timeline is uncertain due to potential regulatory delays.

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CEO & President Michael Feldschuh explained that the next-generation BVA system is a significant leap forward, being the size of a tissue box, weighing as much as a laptop, and reducing test time from 60-90 minutes to just 15 minutes at the point-of-care. He confirmed that data submission to the FDA has begun, with a full 510(k) package expected in Q4 2022 and approval anticipated in early 2023, using their current device as the predicate. To address sales concerns, he outlined a shift to a SaaS model for the new device, offering trade-ins for current customers. He also confirmed a rise in utilization at existing accounts and noted the new system will be highly intuitive, comparing its ease of use to checking in luggage at an airport.

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CEO Raymond Chang confirmed the pipeline figures and expressed confidence in fully recovering funds from the Bud & Mary's lawsuit, citing personal guarantees. He also highlighted a strategic pivot from capital-intensive TTK projects to the more flexible Rapid Deployment Program (RDP). CFO Tim Oakes provided the $646 million backlog figure and explained that while they don't guide on cash flow, the company must operate under its debt agreement's cash spend limit of $8 million per quarter.

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CEO Raymond Chang clarified that the primary issue has been the long 15+ month construction period for TTK projects, not the sales cycle itself, a problem the RDP is designed to solve. He also noted customer-side construction delays are slowing the book-to-burn ratio for extraction equipment. Chang stated that Agrify has commitments for just over 3,500 VFUs. He explained the RDP has a different economic model than the TTK program, involving hardware sales, SaaS fees, and a much lower production fee, making it adaptable to various market conditions.

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CFO Timothy Oakes confirmed the backlog is $923 million, which is expected to be recognized over a 6-8 year period on average. Executive Raymond Chang added that over 80% of this is high-margin, 10-year recurring revenue. Regarding Curaleaf, Chang stated that the project is moving forward with construction applications submitted, but the lengthy process underscored the value of the new Rapid Deployment Program. He also highlighted the success of another customer, WhiteCloud, which is achieving production of nearly 50 pounds per VFU annually.

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CEO Raymond Chang confirmed an LOI for a Phase 2 expansion with parent company Frozen 4, potentially adding up to 1,200 VFUs. He also reiterated that initial recurring revenue is now accelerated to start in Q3 2022. CFO Timothy Oakes addressed the gross margin, explaining the 22% was abnormally high due to high-margin extraction sales and a specific VFU sale. He guided for near-term gross margins to normalize to the mid-teens.

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