Total Revenue

FY 2025

$78 million to $80 million "

$92 million to $96 million " "

raised

Gross Margin

FY 2025

72% to 74% "

73% to 75% " "

raised

Operating Expenses

FY 2025

$80 million to $84 million, including approximately $10 million in stock‐based compensation "

$92 million to $95 million, including approximately $11 million in stock‐based compensation "

raised

Cash & Short-Term Investments

FY 2025

no prior guidance

Sufficient to support planned operations until achieving cash flow breakeven " "

no prior guidance

Project CARE

Q1, Q2, and Q3 discussions detailed the pilot program’s initiation, its educational components, increasing implant and referral activity, and plans for further expansion (e.g., training, center contracting and digital efforts) " " "

Q4 emphasized continued momentum in pilot expansion—with demonstrated increases in implants and referrals, and explicit plans to more than double 2025 CARE-related implants and referrals " " "

Consistent and growing – the program has been a focus throughout with increasing emphasis in Q4

Referral pipeline growth beyond Level 4 centers

Previously mentioned in Q1, Q2 and Q3 as a key aspect of Project CARE, highlighting increased referrals from community centers and tailored approaches to educate and support centers, enabling both direct implants and referrals " " "

Q4 continued to focus on expanding the referral pipeline beyond Level 4 centers, reiterating that growing referrals and implants are critical to broadening market access " "

Stable and integrated – consistent focus with ongoing expansion plans

RNS System adoption driving revenue growth

In Q1, Q2, and Q3 the RNS System was clearly identified as the primary revenue driver with increasing active prescribers, record implants, and reliance on Level 4 centers; some concern was noted around concentration risks, which were partially mitigated by initiatives like Project CARE " " "

In Q4, growth in RNS sales remains the primary revenue engine, with specific mention of a 27% increase (excluding NAUTILUS cases) and strategies to diversify market access to manage concentration risks " " "

Consistent with evolving risk management – strong performance with renewed efforts to diversify

Operational expense management, margin discipline, and cash burn sentiment

Q1 through Q3 consistently addressed disciplined expense management, operating leverage, improvements in gross margins (ranging from 71.7% to 74.5%), and progressively lower or contained cash burn (e.g., Q3 cash burn was reduced) " " "

Q4 detailed a 7% increase in operating expenses but highlighted strong operating leverage with a 75.4% gross margin and a managed cash burn of $4.8 million, supported by strategic capital management "

Steady and disciplined – consistent focus with continued improvements demonstrated in Q4

Market expansion through indication expansion

Earlier periods (Q1, Q2, and Q3) focused on the NAUTILUS study for generalized epilepsy and mentioned indication expansion as part of long-term strategy; pediatric indications were not detailed in Q1 and only briefly alluded to elsewhere " " "

Q4 introduced detailed discussion of expanding indications to include new pediatric patients (with collaborations and real-world data efforts) in addition to generalized epilepsy via the NAUTILUS study, reflecting broader market expansion ambitions " "

Broadening focus – while generalized expansion remains, pediatric indication is now emphasized

DIXI Medical Products growth and margin impact

Q1 through Q3 discussed DIXI’s meaningful revenue contribution (around 15% in earlier periods) and its impact on gross margins due to lower margin profile relative to the RNS System, but noted its strategic and diagnostic integration benefits " " "

In Q4, DIXI Medical products contributed approximately 17% of revenue, reinforcing its growing role despite lower margins that partially offset manufacturing efficiencies achieved with RNS products "

Consistent with slight revenue share increase – steady contribution with persistent margin trade-offs

Commercial expansion strategies

Q1, Q2, and Q3 emphasized incremental hiring and training of a sales force, geographic expansion, active prescriber growth, Project CARE pilot programs, and pipeline metrics as part of an aggressive commercial expansion plan " " "

Q4 reinforced these strategies with continued sales force expansion, record active prescriber numbers, further expansion of Project CARE, and direct-to-consumer efforts as part of the broader strategy to drive future growth " " "

Consistent and robust – ongoing emphasis across periods with continued execution

Seasonality effects and quarterly revenue forecasting variability

In Q1 detailed explanations on mid‐summer slowdowns and holiday impacts, while Q2 acknowledged summer seasonality and variability in quarterly forecasting; Q3 provided brief remarks on quarterly variability " " "

Q4 explicitly noted that although there is inherent quarter-to-quarter variability, the business shows steady growth across 6-month increments (21% in H1 and 23% in H2), with historical patterns expected to continue into 2025 "

Consistent acknowledgment – seasonality remains a factor, with clearer long-term growth trends outlined

Regulatory and reimbursement risks tied to new indication studies

Minimal to no discussion in Q1, Q2, and Q3; the focus was primarily on indication expansion via NAUTILUS without deep dive into regulatory or reimbursement risks " " "

Q4 directly addressed regulatory risks for both generalized and pediatric indications, detailing the NAUTILUS study process, FDA submission plans, and payer engagement to overcome reimbursement challenges " " "

Emerging focus – a new and detailed discussion in Q4 increases transparency and risk awareness

Emerging investments in AI-enhanced R&D tools

Q1 mentioned initial investments in AI-enhanced tools as part of broader R&D strategy, while Q2 had no mention and Q3 provided detailed insights from Joel Becker regarding the excitement and efficiency gains expected from these tools " "

Q4 noted increased R&D spending (from $5.4M to $6.1M) driven partly by investments in AI-powered software and next-generation device projects, reinforcing a commitment to advanced technology in product development "

Emerging and increasingly emphasized – steady progression with expanded investment focus

Strategic financial flexibility

Q1 through Q3 consistently discussed debt maturity, cash management, and initiatives to extend debt maturity (e.g., extension to September 30, 2026) along with incremental cash balance improvements " " " "

Q4 highlighted a strengthened balance sheet following a public offering and share repurchase, with long-term borrowings held at $59.5M due by September 30, 2026, and a pro forma cash balance of $68.6M, supporting operational funding until cash flow breakeven " "

Consistently emphasized – reaffirmed focus on financial flexibility with progressively improved metrics

Declining replacement implant revenue

Q1 acknowledged a trend of reduced replacement implant revenue (expected to be more pronounced early in the year) and Q3 indicated that the trough of this decline had passed, with Q2 noting stable replacement implant revenue levels " " "

Q4 did not mention declining replacement implant revenue, suggesting that it is no longer a crucial focal point in discussions, indicating improved sentiment or reduced concern compared to earlier periods "

Diminishing emphasis – a decreasing focus as the downturn phase ends and strategic attention shifts away