Brett Hale
Analyst · Lake Street Capital Markets
Thank you, Maria. The third quarter delivered strong performance from revenue to cash burn reduction. I will walk through the third quarter results and how they support our full year guidance and the long-term trajectory of the business. These results demonstrate the operating leverage in our business model. Revenue increased 53% sequentially, while operating expenses increased less than 2%. Compared with the second quarter, record revenue and record gross margin generated $1.4 million of additional gross profit against just $0.2 million of additional operating expense. That translated into a narrower operating loss alongside a 29% reduction in net cash burn. Turning to the details. Revenue for the third quarter of 2026 was a record $6.0 million compared to $3.4 million in the third quarter of 2025, representing an increase of $2.5 million or 73% year-over-year and an increase of 53% from the second quarter of 2026. In the third quarter, we sold 14 units compared to 8 units in the prior year period, an increase of 75%. Third quarter growth reflected contributions from all 3 commercial verticals: U.S. hospital, U.S. office and international. As Maria described, commercial momentum included new and follow-on health system orders, expansion across hospital sites of care, adoption in neurology offices and initial concierge practices and the international rollout of Model 2. This growth was organic and broad-based with no onetime items. Revenue growth reflected higher unit sales and a record average selling price. Service revenue also increased 31% year-over-year, reflecting continued expansion of our installed base. Gross profit for the third quarter of 2026 was a record $3.4 million compared to $1.8 million in the third quarter of 2025, an increase of $1.5 million or 83%. Gross margin was a record 56.7% compared to 53.8% in the prior year period and 50.7% in the second quarter. That represents approximately 300 basis points of year-over-year expansion and 600 basis points of sequential expansion. This is our fifth consecutive quarter with gross margin above 50%. Higher average selling prices, Model 2 mix and increased scale supported margin improvement. R&D expenses for the third quarter of 2026 were $3.9 million compared to $4.0 million in the third quarter of 2025, a decrease of 3%. We continue to realize the benefits of our 2025 reorganization while maintaining our investments in priority software and clinical programs. Those investments supported the latest Optive AI software release and completion of our enrollment in the Contrast PMR study, tangible progress in improving the system today and pursuing expanded clinical utility. Sales, general and administrative expenses for the third quarter of 2026 were $6.7 million, flat compared to the third quarter of 2025. Within that total, sales and marketing expenses increased 4% year-over-year, while revenue grew 73% over the same period. Our lean and shared U.S. sales organization serves hospital and office markets with complementary sales cycles and our distribution partners extend our reach internationally. Follow-on health system orders build on existing contracts, approvals, implementations and clinical and executive champions, so they typically require less time and selling efforts. This commercial model allows us to grow revenue significantly faster than sales and marketing expenses. Moving down the P&L. Operating loss for the third quarter of 2026 was $7.3 million, our narrowest quarterly operating loss and an improvement of 19% compared to the third quarter of 2025 and 14% compared to the second quarter of 2026. These improvements reflected higher gross profit with a largely stable operating expense base. Net loss for the third quarter of 2026 was $6.0 million, equating to a net loss of $0.06 per share compared to a net loss of $11.0 million or $0.14 per share in the third quarter of 2025. The third quarter of 2026 net loss included a $1.5 million noncash gain from the change in fair value of warrant liabilities compared to a $2.3 million noncash loss in the prior year period. Net cash burn in the third quarter was $5.6 million compared to $5.9 million in the third quarter of 2025, an improvement of 6% year-over-year and 29% sequentially. Net cash burn has declined every quarter this year, from $8.8 million in the first quarter to $7.9 million in the second quarter to $5.6 million in the third, our lowest quarterly net cash burn. For the first time, quarterly revenue exceeded quarterly net cash burn, a meaningful milestone in building a more capital-efficient business with stronger commercial performance and lower cash consumption. As of September 30, 2026, we had $37.9 million in cash and cash equivalents on our balance sheet with no capital raise since June 30, 2026. Taken together, the third quarter demonstrates our ability to grow revenue and gross profit without a comparable increase in spending while reducing cash burn. Our progress supports our confidence in the full year outlook. Turning to 2026 guidance. We are reaffirming our full year revenue and net cash burn guidance, and we are raising the low end of our gross margin guidance. Revenue for the first 9 months of 2026 was $13.8 million, up 66% year-over-year. We sold 36 units, up 64% year-over-year, and unit sales have grown each quarter this year. We reaffirm full year revenue guidance of $20 million to $22 million, representing approximately 55% growth at the midpoint. Our outlook builds on the contributions from all 3 commercial verticals and several identifiable tailwinds. First, in the hospital and IDN, we see opportunities for new and follow-on orders and expansion across sites of care, supported by the first full annual capital planning cycle since the Model 2 launch. Second, in the office, continued adoption, strong utilization and early demand from concierge practices expands our opportunity. Third, internationally, Model 2 is gaining traction as the rollout continues. Year-to-date gross margin was 53.3%, and we are raising the low end of our full year gross margin guidance, narrowing the range from 50% to 55% to 52.5% to 55%, reflecting our confidence in the durability of these margin gains. Our strong clinical and economic value proposition supports healthy average selling prices, while Model 2 mix and increasing scale have supported margin improvement. We also reaffirmed our full year 2026 net cash burn guidance of $26 million to $28 million, representing approximately a 10% year-over-year decline at the midpoint. We continue to execute against our operating plan and reaffirm our expected cash runway into 2028, assuming no additional financing, including no future debt draws. Our $37.9 million in cash and cash equivalents as of September 30, 2026, our improved cash burn and identifiable commercial growth drivers underpin that outlook. We believe this positions us well to fund our commercial and product priorities while maintaining discipline in spending and capital deployment. Our debt facility provides potential additional financial flexibility with up to $25 million of remaining capacity subject to the conditions in our loan agreement. In summary, the third quarter delivered record revenue and gross margin. That commercial progress is translating into operating leverage and lower cash burn. Our outlook, including a raised gross margin floor reflects the progress we have delivered and the identifiable opportunities ahead. With that, I will turn the call back to Maria for closing comments.