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01/10 16:15
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Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call summary presents mixed signals. The financial performance shows a slight improvement in net loss per share, and cash reserves are healthy. However, guidance was cut on the higher end, and sales force productivity is not fully realized. The Q&A reveals cautious optimism, with potential growth in 2026 but conservative Q4 guidance. There are positive developments in gross margin and reimbursement, but uncertainties in productivity improvements and market expansion remain. Without a market cap, the overall sentiment is neutral, expecting minimal stock movement.
Revenue Revenue was $14.7 million for the 3 months ended September 30, 2025, an increase of $1.3 million or 10% over the 3 months ended September 30, 2024. The increase was primarily driven by continued growth in the U.S. heart failure business as a result of the expansion into new sales territories, new accounts, and increased physician and patient awareness of Barostim.
Revenue in the U.S. Revenue generated in the U.S. was $13.5 million for the 3 months ended September 30, 2025, an increase of $1.2 million or 10% over the 3 months ended September 30, 2024. The increase was driven by the same factors as overall revenue growth.
Revenue in Europe Revenue generated in Europe was $1.2 million for the 3 months ended September 30, 2025, an increase of $0.1 million or 12% over the 3 months ended September 30, 2024. However, total revenue units in Europe decreased to 50 from 56 in the prior year period.
Gross Profit Gross profit was $12.8 million for the 3 months ended September 30, 2025, an increase of $1.5 million or 15% over the 3 months ended September 30, 2024. Gross margin increased to 87% from 83% in the prior year period, driven by an increase in the average selling price and a decrease in the cost per unit due to improved manufacturing efficiencies.
R&D Expenses R&D expenses increased $0.6 million or 26% to $3.1 million for the 3 months ended September 30, 2025, compared to the prior year period. This was driven by a $0.5 million increase in compensation expenses and a $0.2 million increase in consulting expenses, partially offset by a $0.2 million decrease in clinical trial expenses.
SG&A Expenses SG&A expenses increased $0.2 million or 1% to $21.9 million for the 3 months ended September 30, 2025, compared to the prior year period. This was primarily driven by increases in consulting, travel, and non-cash stock-based compensation expenses, partially offset by decreases in advertising and compensation expenses.
Interest Expense Interest expense increased $0.5 million for the 3 months ended September 30, 2025, compared to the prior year period. This was driven by higher levels of borrowings under the term loan agreement with Innovatus Capital Partners.
Net Loss Net loss was $12.9 million or $0.49 per share for the 3 months ended September 30, 2025, compared to a net loss of $13.1 million or $0.57 per share for the prior year period. The improvement in net loss per share was due to an increase in weighted average shares outstanding.
Cash and Cash Equivalents As of September 30, 2025, cash and cash equivalents were $85.1 million. Net cash used in operating and investing activities was $10 million for the 3 months ended September 30, 2025, compared to $10.4 million for the prior year period.
Barostim therapy: The company is focusing on improving patient access, expanding therapy awareness, and building clinical evidence. CMS proposed maintaining Barostim in new technology APC 1580 with payment of approximately $45,000 for outpatient procedures. Transition to a Category I CPT code effective January 1, 2026, will improve prior authorization predictability and ensure fair physician payment.
U.S. market expansion: Revenue in the U.S. increased by 10% year-over-year to $13.5 million, driven by new sales territories, accounts, and increased awareness of Barostim. The number of active implanting centers grew to 250, and sales territories increased to 50.
European market: Revenue increased by 12% year-over-year to $1.2 million, though total revenue units decreased from 56 to 50. Sales territories remained consistent at 5.
Sales force transformation: The company is building a world-class sales organization, with turnover returning to normal levels. New sales reps are being onboarded and contributing meaningfully. The number of sales reps contributing implants reached a record high in Q3.
Manufacturing efficiencies: Gross margin increased to 87% from 83% year-over-year due to higher average selling prices and reduced cost per unit.
Strategic account targeting: The company is focusing on high-potential Tier 1 and Tier 2 accounts while selectively pursuing Tier 3 and Tier 4 accounts with committed physician champions and administrative support.
Clinical evidence and FDA discussions: The company is expanding its clinical evidence portfolio with positive patient outcomes reported. Discussions with the FDA for a new randomized controlled trial are progressing, with an IDE application submitted in October.
Sales Force Turnover: Although turnover is returning to normal levels, the company has faced challenges in maintaining a stable sales force, which could impact the consistency of sales efforts and customer relationships.
Territory Expansion: The company is expanding its sales territories, but this requires careful alignment of hiring and onboarding processes to ensure new hires are productive, which could delay revenue growth if not managed effectively.
Reimbursement Challenges: While progress has been made in reimbursement policies, the transition to a Category I CPT code and securing Category B IDE coverage are still pending, which could delay broader adoption of Barostim therapy.
Regulatory Uncertainty: Discussions with the FDA regarding a new randomized controlled trial are ongoing, and any delays or disagreements could impact the company's ability to generate new clinical evidence and secure necessary approvals.
Financial Losses: The company reported a net loss of $12.9 million for Q3 2025, indicating ongoing financial challenges that could limit its ability to invest in growth initiatives.
Interest Expense: Increased interest expenses due to higher borrowings could strain financial resources and impact profitability.
European Market Performance: Revenue units in Europe decreased, which could indicate challenges in market penetration or competition in that region.
Revenue Guidance for Full-Year 2025: The company expects total revenue between $55.6 million and $56.6 million, compared to prior guidance of $55 million to $57 million.
Gross Margin Guidance for Full-Year 2025: The company now expects full-year gross margin between 85% and 86%, compared to prior guidance of 83% to 84%.
Operating Expenses Guidance for Full-Year 2025: The company now expects operating expenses between $98 million and $99 million, compared to prior guidance of $96 million to $98 million.
Revenue Guidance for Q4 2025: The company expects to report total revenue between $15 million and $16 million.
Transition to Category I CPT Code: Effective January 1, 2026, the company will transition to a Category I CPT code, which will eliminate experimental and investigational denials, improve prior authorization predictability, and ensure fair and consistent physician payment for procedures.
FDA IDE Application and Potential New Trial: The company submitted an IDE application in mid-October 2025 and expects feedback from the FDA in late November 2025. If approved, the company plans to approach CMS for Category B IDE coverage to move forward with a new randomized controlled trial.
The selected topic was not discussed during the call.
The earnings call summary presents mixed signals. The financial performance shows a slight improvement in net loss per share, and cash reserves are healthy. However, guidance was cut on the higher end, and sales force productivity is not fully realized. The Q&A reveals cautious optimism, with potential growth in 2026 but conservative Q4 guidance. There are positive developments in gross margin and reimbursement, but uncertainties in productivity improvements and market expansion remain. Without a market cap, the overall sentiment is neutral, expecting minimal stock movement.
The earnings call reflects mixed signals: while there is progress in sales force expansion and potential improvements in reimbursement processes, the guidance was narrowed, and gross margin guidance remains unchanged despite a Q2 beat. The Q&A reveals management's cautious optimism but also highlights uncertainties, particularly in reimbursement changes and Tier 3/4 account impacts. Without a clear market cap, the lack of strong positive catalysts and vague management responses suggest a neutral stock price movement in the short term.
The earnings call presents a mixed picture: strong revenue growth and positive reimbursement changes are offset by ongoing financial losses and operational risks. The Q&A reveals management's focus on expanding market penetration and addressing awareness issues, but also highlights uncertainties in cash burn and target account strategies. The issuance of new shares and stable gross margins suggest financial stability, but the lack of clear guidance on certain metrics tempers enthusiasm. Given these factors, a neutral stock price movement is expected over the next two weeks.
The earnings call presents a mixed picture. Financial performance shows strong revenue growth, but increased expenses and a widened net loss raise concerns. Positive elements include optimistic guidance and strategic initiatives. However, the equity offering and increased loan could dilute value. The Q&A reveals confidence in reimbursement efforts but lacks clarity on some financial impacts. The neutral rating reflects these balanced factors, with potential for volatility due to unclear guidance and financial adjustments.
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