William Plovanic

William Plovanic asked about the break-even period for the pay-as-you-go model in months, and inquired about the free cash flow expectations for 2026 (specifically if it will be positive) and the quarterly cadence of cash burn, given that Q1 is typically a heavy cash burn quarter.

Answer

EVP and CFO Leigh Vosseller explained that for an individual pay-as-you-go customer, it takes several months to cover the $0 upfront pump cost with supply sales. However, by combining one pay-as-you-go customer with two existing customers shifting to pharmacy, the payback period is reduced to a handful of months. She stated that for 2026, the company expects to be free cash flow neutral on an annual basis, with a typical Q1 dip due to annual incentives, but ramping up to a positive position by year-end and into 2027. President and CEO John Sheridan added that the pay-as-you-go model eliminates significant DME barriers, such as high upfront out-of-pocket costs and administrative friction, which will drive new patient uptake.

William Plovanic inquired about the break-even period for the PayGo model in Tandem Diabetes Care's models and sought expectations for free cash flow in 2026, including its quarterly cadence, particularly regarding the typical Q1 cash burn.

Answer

EVP and CFO Leigh Vosseller explained that for an individual PayGo customer, it takes several months to cover the $0 pump with supply sales. However, by shifting existing customers, one PayGo customer plus two existing customers can break even within a 'handful of months.' For 2026, she expects free cash flow to be neutral, ramping up to positive by year-end and into 2027, acknowledging a typical Q1 dip due to annual incentives. CEO John Sheridan added that PayGo eliminates significant DME barriers, driving new patient uptake.

William Plovanic asked if the Q1 SG&A spending level should be considered the new nominal run-rate for the remainder of the year.

Answer

CFO Leigh Vosseller explained that the year-over-year increase was driven by the U.S. salesforce expansion and OUS infrastructure investments. However, she clarified that the quarterly step-up will not be as significant going forward, as cost-saving initiatives in customer support will help fund these investments.

William Plovanic from Canaccord Genuity asked about the cash flow impact of the pharmacy channel model and questioned if 2025 is being treated as a transition year where free cash flow is reinvested into the business.

Answer

Leigh Vosseller, Executive Vice President and Chief Financial Officer, clarified that at the currently anticipated small volume, the pharmacy channel has no material impact on the business model or cash flow. She confirmed that 2025 is an investment year for long-term growth, but these investments are being funded by other cost-saving initiatives, allowing for margin leverage.

William Plovanic sought clarification on whether the 25% Type 2 penetration target referred to new patient starts or the total market.

Answer

President and CEO John Sheridan clarified that his comment referred to the potential for penetration to exceed 25% of the total U.S. insulin-intensive Type 2 market over the next several years. He also noted that competitors having a T2D label is beneficial for building overall market awareness among providers.

William Plovanic asked about the competitive impact of a new market entrant on AtriCure's AtriClip business and the expected timeline for LeAAPS trial data release, specifically regarding the 50% and 75% event rates.

Answer

Mike Carrel, President and CEO of AtriCure, viewed the competitive entry as market validation, noting a positive impact on revenue growth, particularly 24% in open left atrial appendage management. He highlighted AtriCure's leadership, continuous innovation (10th generation product, FLEX-Mini, PRO-Mini, new product in 2027), extensive clinical evidence (750,000 implants, 0.007% safety rate, 21,000+ patients, 100+ peer-reviewed articles), and the LeAAPS trial's potential for further differentiation. Regarding LeAAPS data, Mr. Carrel clarified that the 50% event rate resulted in a 'thumbs up continue' from the DSMB, not specific data release, with the same process expected at 75% and final results at 100% of events.

William Plovanic asked about AtriCure's perspective on a competitor entering the market and its potential competitive impact, as well as an update on the expected timeline for LEAPS trial data release, specifically regarding the 50% and 75% event rate milestones.

Answer

President and CEO Mike Carrel welcomed the competition, viewing it as market validation and noting that previous competitive entries had positively impacted revenue growth, citing 24% growth in the open left atrial appendage management business. He highlighted AtriCure's leadership, continuous innovation (10th generation product, Flex Mini, Pro Mini, future product in 2027), extensive clinical evidence (750,000 implants, 0.007% safety rate, 21,000+ patients studied, 100+ peer-reviewed articles), and the LEAPS trial's potential to further differentiate by demonstrating stroke reduction in non-AFib cardiac surgery patients. Regarding LEAPS data, Carrel clarified that the company receives a 'thumbs up continue' from the DSMB at 50% and 75% event rates, not specific data for early release, and confirmed they have passed the 50% event rate with a positive DSMB review.

William Plovanic asked for clarification on the potential impact of tariffs on the business and questioned the drivers behind the accelerated growth in the appendage management franchise.

Answer

CFO Angela Wirick stated that any tariff impact is expected to be modest, measured in tens of basis points on gross margin, and is already factored into the company's guidance. CEO Michael H. Carrel attributed the strong appendage management performance directly to the successful launch and rapid adoption of the new AtriClip FLEX-Mini device, which is attracting new accounts and surgeons at a rate twice as fast as anticipated.

William Plovanic from Canaccord Genuity Group Inc. asked about the rollout status of EnCompass outside the U.S. and the new cryo-probes in the U.S., and also questioned the reason for the increase in the 2025 adjusted EBITDA guidance.

Answer

CEO Michael H. Carrel stated that the EnCompass OUS launch is in its very early stages, while the U.S. launches of cryoSPHERE MAX and FLEX-Mini are also in early innings but showing strong initial progress. CFO Angela Wirick added that the EBITDA guidance was raised due to the strong finish to 2024 and observed business efficiencies, increasing confidence for 2025.

William Plovanic sought clarification on the EnCompass Clamp's 50% U.S. growth and asked about the expected impact of its recent European CE mark approval. He also questioned whether the new PFA partnership investment alters the company's timeline for achieving consistent positive cash flow.

Answer

CFO Angela Wirick confirmed the EnCompass Clamp's U.S. growth was approximately 50%. CEO Michael H. Carrel added that while the European launch was well-received, a significant revenue impact is not expected until 2025 due to reimbursement processes. Regarding cash flow, Ms. Wirick stated the PFA investment was part of the existing R&D plan and does not change the company's trajectory toward profitability, with a modest cash burn still expected for the full year 2024.

William Plovanic asked for specific numbers on the commercial organization's size and targets, the net number of accounts, the rationale for pushing out profitability, and usage trends between TACE and TARE procedures.

Answer

CEO Mary Szela stated the commercial team is about 45 people, with a goal to reach 60-70 over 18 months. CFO James Young estimated total accounts in the low-to-mid 300s. Szela explained the profitability pushout is driven by strategic investments: 60% for commercial expansion and 40% for new clinical registries. Dr. Richard Marshall added that while historically a 50-50 split, TARE is now trending significantly higher than TACE, a path TriNav is expected to follow.

William Plovanic of Canaccord Genuity inquired about the commercial attachment rate for mapping procedures, the potential next steps for the pancreatic cancer program post-data, and the materiality and status of the 10-K filing delay. He also revisited the topic of the 2025 growth cadence.

Answer

CEO Mary Szela and Medical Director Dr. Richard Marshall indicated the mapping-to-treatment attachment rate is close to 1:1 in commercial cases. For the pancreas program, Szela stated the next step would likely be a Phase II/III trial, probably with a partner, but decisions are pending final data. Regarding the 10-K delay, CFO James Young explained it relates to stock-based compensation and R&D expense timing with new auditors, but he could not comment on the potential materiality of adjustments while the audit is ongoing. Young also reiterated that 2025 growth is expected to be more back-end loaded as new accounts ramp up utilization.

William Plovanic of Canaccord Genuity sought confirmation on the 2024 revenue outlook, asked for color on the monthly sales cadence through Q3 and into Q4 to understand seasonality, and questioned the path to positive cash flow given the Q3 cash burn rate. He also asked for interpretation of the PERIO-03 update, particularly regarding efficacy signals.

Answer

Chief Financial Officer Sean Murphy confirmed the 2024 revenue guidance of $28M-$30M. He noted Q3 sales were slow in July and August but hit a record high in September. He projected the Q4 cash burn would decrease to $4M-$4.5M from over $11M in Q3, driven by lower R&D and G&A expenses. President and CEO Mary Szela explained the PERIO-03 update was pushed to mid-2025 to allow for longer patient follow-up and analysis of tissue samples to correlate results with the modulation of the tumor microenvironment.

William Plovanic questioned the significant increase in accounts receivable and asked for clarity on the full-year guidance, which implies flat sequential performance for the remainder of the year. He also sought confirmation on the expected revenue contribution from clinical trials.

Answer

Executive Waleed Hassanein confirmed the clinical trial contribution remains in the 2-5% range for the year, likely at the lower end. CFO Gerardo Hernandez explained the receivables increase was due to billing timing and expects DSOs to normalize, aided by a new automated billing system in H2. Regarding guidance, Hassanein noted that while they expect modest improvement from Q1, the forecast prudently accounts for potential seasonality.

William Plovanic of Canaccord Genuity inquired about the company's exposure to issues raised in a New York Times article on organ allocation, recent trends in UNOS transplant data, and the expected revenue contribution from new clinical programs in the 2025 guidance.

Answer

CEO Waleed Hassanein stated the company's business would not be meaningfully impacted by the allocation issues, framing broader allocation as necessary for organ utilization. He viewed positive UNOS data as normal market variability. For the 2025 guidance, he clarified that the new heart and lung programs are expected to contribute a "miniscule" 2% to 5% of the total revenue growth for the year.

William Plovanic of Canaccord Genuity Group Inc. sought clarity on the Q4 outlook, asking if management expects stabilization or a significant pickup to meet guidance. He also inquired about the service margin run rate after excluding $2 million in one-time costs.

Answer

CEO Waleed Hassanein stated that the gap from the national volume decline began closing significantly in October, giving them confidence in their guidance. CFO Stephen Gordon explained the $2 million in costs were non-recurring and that service margins were also impacted by higher reliance on third-party logistics due to aircraft maintenance. He expects margins to improve as they use their own fleet more efficiently.

William Plovanic asked for confirmation on the full-year 2025 revenue guidance breakdown between the legacy Neuronetics business and Greenbrook. He also sought clarity on the drivers of Greenbrook's outperformance, the source of strength in the core business, and an explanation for the higher-than-expected G&A spend in Q1, requesting the normalized OpEx run-rate for Q2.

Answer

Executive Keith Sullivan confirmed strong performance, noting Greenbrook's same-store TMS business grew 8% and SPRAVATO grew 50% year-over-year. Executive Stephen Furlong explained that Q1 operating expenses were intentionally higher due to pulling forward approximately $5 million in cash expenses for vendor payments and bonus cycle synchronization following a recent financing. He affirmed that full-year OpEx guidance is unchanged and projected a normalized Q2 OpEx in the $23 million to $24 million range.

William Plovanic asked about the integration timeline for the Better Me Provider (BMP) program at Greenbrook sites and sought clarification on the drivers behind the 2025 revenue and operating expense guidance.

Answer

CEO Keith Sullivan stated that training for Greenbrook staff is ongoing and primarily virtual, allowing for continuous implementation. CFO Steve Furlong detailed the revenue guidance, attributing $65-$70 million to standalone Neuronetics and $80-$85 million to Greenbrook. He also explained that the OpEx guidance of $90-$98 million reflects the inclusion of Greenbrook's corporate expenses offset by $13-$15 million in realized cost synergies.

William Plovanic from Canaccord Genuity asked for granularity on business trends, comparing the Greenbrook and non-Greenbrook segments. He also questioned the magnitude of the Q4 guidance cut and sought specifics on the strategic changes in the commercial organization.

Answer

CEO Keith Sullivan was hesitant to comment on Greenbrook's specific performance pre-close but noted their TMS business remains strong. CFO Stephen Furlong attributed the bulk of the guidance shortfall to a strategic commercial restructuring aimed at prioritizing profitability. He detailed the new strategy involves adopting Greenbrook's Regional Area Manager (RAM) model to more efficiently drive patient referrals to all NeuroStar sites, shifting focus to treatment sessions and second-system sales within existing accounts.

William Plovanic of Canaccord Genuity asked if the per-diem reimbursement for the new 15-day sensor would be adjusted during contracting to be more price-competitive, potentially lowering the price per day for payers.

Answer

COO Jacob Leach stated that since CGM is reimbursed as a unit for a period of time (e.g., per month), the company anticipates that the reimbursement level will remain the same for the 15-day product as it is for the current sensor, resulting in the same revenue for a given coverage period.

William Plovanic asked about the long-term profitability outlook beyond 2025, specifically whether operating margin expansion could accelerate beyond a gradual pace.

Answer

CFO Jereme Sylvain identified two main levers for profitability. First is continued operating expense leverage, particularly in G&A, while still investing heavily in R&D and S&M for growth. The second, more significant lever is gross margin expansion, with a goal to return to 65% and beyond, driven by the G7 15-day sensor and other cost-down initiatives.

William Plovanic asked for an update on the initial $40 million Stelo revenue guidance for 2024 and whether the company has observed any Stelo users converting to the reimbursed G7 product.

Answer

CEO Kevin Sayer did not confirm the $40 million figure, stating the primary goal of the launch was learning, which has been 'spectacular.' He reported a user base of over 70,000. While not seeing a massive trend of direct conversions, he noted the Stelo message is effectively enabling sales reps to initiate conversations in primary care offices that lead to G7 prescriptions.

William Plovanic inquired about the growth drivers for Lightning Bolt 6X and 7, specifically the mix of volume versus price, sought an update on applying CAVT to coronary arteries, and questioned the conservative guidance given the strong Q1 performance.

Answer

CEO Adam Elsesser clarified that growth is almost entirely from volume, as products like Bolt 6X are used in new cases that were previously open surgery. He noted that for coronary, the current product is very effective, making the need for CAVT less clear. He attributed the conservative guidance to prudence, stating it's early in the year and the company has learned from past experiences.

William Plovanic from Canaccord Genuity sought clarification on the THUNDER trial's regulatory status, asking if it had been submitted to the FDA or if discussions had occurred. He also questioned if the Q4 R&D spend of $20 million represents a new, lower baseline for future quarters.

Answer

CEO Adam Elsesser stated they have not yet submitted the THUNDER trial data to the FDA, as the trial follow-up just concluded and data organization is in process. Regarding R&D, he and EVP Jason Mills clarified that the company will continue to invest aggressively in innovation and that quarterly spend will fluctuate based on project needs, not a fixed budget. They also noted that some savings from the Immersive Healthcare exit were in the R&D line.

William Plovanic asked about utilization trends, specifically if the high level of headbands per account seen in Q4 represents a new baseline. He also questioned if accelerated rep hiring would impact 2025 account additions, the status of converting non-Clarity accounts, and progress with the VA hospital opportunity.

Answer

CFO Scott Blumberg stated that while utilization is on an upward trajectory, it may not be linear due to seasonality and inconsistent customer purchasing patterns. He reiterated that new rep hires will primarily impact 2026 growth. He noted the focus is on new accounts over converting the small base of legacy non-Clarity customers. CEO Jane Chao added that a dedicated director is focused on the VA system, where CeriBell is seeing significant interest, with hopes to share tangible milestones soon.

William Plovanic asked about utilization trends, questioning if the Q4 headband-per-account level represents a new baseline. He also inquired about the impact of faster rep hiring on 2025 account adds, the status of converting non-Clarity accounts, and any updates on the VA hospital opportunity.

Answer

CFO Scott Blumberg noted that while utilization is on an upward trajectory, it can be non-linear due to seasonality and customer purchasing patterns. He reiterated that new rep hires will primarily impact 2026 growth. Regarding legacy accounts, he said the focus is on new customer acquisition, which will dilute the non-Clarity base over time. CEO Jane Chao added that the company has a dedicated director for the VA system and is seeing significant interest, with hopes for tangible updates next quarter.

William Plovanic from Canaccord Genuity sought clarification on the VA's Authority to Operate (ATO), asking if it opens a completely new market or allows for upselling existing VA customers to the Clarity platform. He also inquired about how the larger-than-expected IPO proceeds might alter the company's investment timeline for international expansion or new clinical indications.

Answer

CEO Xingjuan Chao explained that while a very small number of VA hospitals used the basic hardware previously, the ATO is critical as it now allows the full cloud-based solution, including the Clarity AI and EEG portal, to be deployed. She noted it's best to view the 200 VA hospitals as new account opportunities. CFO Scott Blumberg added that the company is evaluating how to best use the additional IPO funds as part of its 2025 operating plan and expects to provide more granularity on the next earnings call.

William Plovanic sought clarification on the VA's Authority to Operate (ATO), asking if it opens a new market or enables upgrades for existing accounts, and also inquired about the timeline for detailing plans for the larger-than-expected IPO proceeds.

Answer

Executive Xingjuan Chao explained the VA ATO effectively opens a new market of 200 hospitals, as existing VA accounts have very limited usage without cloud access. CFO Scott Blumberg stated that more granular details on the use of IPO proceeds would likely be shared on the next earnings call after the 2025 operating plan is finalized.

William Plovanic questioned the strategy for overcoming adoption hurdles with heart failure specialists and whether progress would be gradual. He also asked if the equalized inpatient reimbursement has shifted procedure settings and sought rationale for reducing a European sales territory.

Answer

Executive Kevin Hykes explained that overcoming physician adoption barriers is a gradual process focused on awareness, clinical evidence, and patient access. Executive Jared Oasheim noted no material shift to inpatient procedures was seen in Q4 but will be monitored. He added that the European territory reduction was a strategic decision to reduce spending in a less productive area, with revenue expected to remain flat.

William Plovanic questioned the strategy for increasing adoption among Heart Failure specialists, asking if it would be a gradual process or a significant inflection. He also asked about any observed shift to inpatient procedures following the reimbursement change and the rationale for reducing an international sales territory.

Answer

Executive Kevin Hykes characterized the strategy to boost physician adoption as a gradual 'whittling down' of barriers like awareness and clinical evidence, rather than a single inflection point. Executive Jared Oasheim added that no material shift to inpatient procedures was seen in Q4 and that the reduction in European territories was a strategic decision to reduce spending in a less productive region, with revenue expected to remain stable.

Asked for quantification on the expansion of sales territories by promoting associate sales reps. Also inquired about the potential for a price premium with the full launch of the new AdaptiveAI product.

Answer

The company declined to provide specific numbers on territory expansion but explained their strategy of promoting trained internal reps into adjacent territories should lead to a faster ramp-up. Regarding pricing for AdaptiveAI, they stated that while they will seek a premium for new technology where possible, it is too early to predict an ASP increase as it requires negotiating new hospital contracts, which is a lengthy process.

Sought clarification on Vyrsa's 2024 revenue contribution, asked about the geographic growth split, and questioned the conservatism of the OpEx and gross margin guidance.

Answer

The company clarified no specific revenue number was given for Vyrsa. They expect roughly equal growth between U.S. and international markets. The OpEx and margin guidance was defended by citing Q1 seasonal spending increases, offsetting cost pressures (inflation, merit increases) against layoff savings, and margin headwinds from inventory levels and product mix.

William Plovanic inquired about the impact of the AID system launch on the commercial organization, particularly on patient service, and whether the focus has shifted more towards selling versus ongoing support.

Answer

President and CEO Jim Hollingshead emphasized a focus on a 'differentiated end-to-end customer experience.' He acknowledged that initial demand for Omnipod 5 in 2022 strained support services but stated, 'those days are behind us.' He affirmed that all customer-facing functions have been scaled and are now 'laser-focused' on providing the best experience, leveraging the product's cloud connectivity.

William Plovanic of Canaccord Genuity asked for key milestones to measure progress on the FDA remediation efforts and inquired about the risk of the recent 483 observations escalating to a warning letter.

Answer

CEO Quentin Blackford declined to speculate on future FDA actions but emphasized their commitment to a comprehensive remediation, which has been communicated to the agency. He stated there may not be many visible public milestones, but the company reports progress to the FDA monthly and committed to providing investors with updates on whether they are on track with their internal remediation timelines.

Sought clarification on the Q3 sequential growth guidance, asking if it was a signal that consensus estimates were too high. He also asked whether the Q2 upside from the VenaCore launch was due to initial stocking (sell-in) or underlying demand (sell-through) and its expected ramp.

Answer

Management clarified that the Q3 guidance reflects a tougher year-over-year comparison and a Q4-weighting of catalysts this year, suggesting the analyst's math was directionally correct. The VenaCore launch saw enthusiastic physician feedback and has a long runway for growth. It is also showing unexpected utility in DVT, potentially strengthening that franchise.

Asked about the commercialization strategy for LimFlow, including the timeline for expansion, the impact of the proposed NTAP, and its Q1 contribution. Also questioned the conservative Q2 guidance of flat-to-up sequential growth, a pattern not seen since 2020.

Answer

2024 is a foundational year for LimFlow, focusing on training, approvals, and supply chain. The proposed NTAP is a key milestone that will support a broader commercial ramp in 2025. Regarding Q2 guidance, the company has observed seasonality in the past two years and is being thoughtful about that dynamic. They see catalysts for acceleration in the back half of the year and noted that even flat-to-up growth would represent over 20% year-over-year growth.

Asked for commentary on competitive dynamics and share impact in 2023 and 2024, and sought clarification on which LimFlow-related costs were excluded from non-GAAP operating loss figures.

Answer

Competitive trialing had an impact on 2023 revenue but the company is confident in maintaining its market leadership. Regarding costs, the non-GAAP figures only exclude the one-time acquisition-related costs for LimFlow, not its ongoing operational costs. These one-time costs are expected to be around $9M in Q1 and then drop to the $4-5M range quarterly for the rest of 2024. The company's profitability target is based on GAAP measures.