Access earnings results, analyst expectations, report, slides, earnings call, and transcript.
The earnings call reflects a positive sentiment with strong revenue growth, improved margins, and reduced losses. The introduction of the Category 1 CPT code and insurance coverage expansion are significant catalysts. Despite some uncertainties in product development timelines, the overall outlook is optimistic with expectations of increased margins and breakeven targets. The Q&A session reinforces this positivity, highlighting strong market feedback and minimal risk exposure. Given these factors, the stock is likely to experience a positive movement in the coming weeks.
Revenue Q4 2024 $761,000, up 43% from $531,000 in Q4 2023 due to increased unit sales from undiscounted insurance reimbursement and financial assistance programs.
Revenue FY 2024 $2.7 million, an increase of 9% compared to $2.5 million in FY 2023, driven by a 19% increase in unit sales from financial assistance programs.
Gross Margin Q4 2024 86.4%, unchanged from Q4 2023, despite an increase in discounted financial assistance units.
Gross Margin FY 2024 86.5%, down from 87.7% in FY 2023, due to growth in discounted device deliveries.
SG&A Expenses Q4 2024 $2.1 million, up 2% from $2 million in Q4 2023, due to hiring and a short-term incentive plan.
SG&A Expenses FY 2024 $9.5 million, up 7% from $8.8 million in FY 2023, due to increased headcount and one-time costs.
Operating Loss Q4 2024 $1.5 million, improved by 10% from $1.6 million in Q4 2023, due to higher sales volumes.
Operating Loss FY 2024 $7.2 million, an increase of 7% from $6.7 million in FY 2023, due to higher SG&A costs.
Net Loss Q4 2024 $1.5 million, a decrease of 73% from $5.3 million in Q4 2023, primarily due to a lower operating loss.
Net Loss FY 2024 $8.2 million, a decrease of 45% from $14.6 million in FY 2023, due to the absence of debt extinguishment charges.
Cash on Hand $3.7 million as of December 31, 2024, with no long-term debt.
Cash Used in Operations FY 2024 $6.1 million, $595,000 lower than FY 2023, due to more stock issuance for services and lower interest payments.
IB-Stim: Continuing commercialization of IB-Stim technology for IBS, with significant growth of 43% in Q4 2024.
RED: FDA clearance received for RED, a rectal expulsion device, allowing for a soft launch.
Market Expansion: Expansion of IB-Stim age indication from 11-18 years to 8-21 years, nearly doubling market opportunity.
Covered Lives: Increase in covered lives from 4 million to approximately 51 million.
Operational Efficiency: Achieved a Category 1 CPT code effective January 1, 2026, facilitating easier billing and reimbursement.
Revenue Growth: Revenue in Q4 2024 was $761,000, up 43% year-over-year.
Strategic Shift: Focus on obtaining national insurance coverage and effective CPT code to drive revenue growth.
Insurance Coverage Risks: The company faces challenges in obtaining written insurance policy coverage on a national level, which is critical for revenue growth. The lack of coverage has hindered the adoption of their technology in children's hospitals.
Regulatory Risks: The effective date for the Category 1 CPT code is January 1, 2026, which is crucial for billing and reimbursement. Delays or changes in regulatory approvals could impact revenue.
Market Adoption Risks: Despite significant growth in covered lives, the company is still treating a small percentage of the addressable market due to insurance barriers. This limits potential revenue.
Economic Factors: The company relies on insurance reimbursement for revenue, and any economic downturns affecting healthcare spending could impact their financial performance.
Operational Risks: The transition from discounted financial assistance to full reimbursement is expected to take time, which may delay revenue realization.
Competition Risks: The competitive landscape in the healthcare technology sector may pose challenges as other companies may offer similar or superior solutions.
Commercialization Strategy: Continuing accomplishments in commercialization strategies for IB-Stim and RED, with significant growth in covered lives and new FDA indications.
Market Expansion: IB-Stim age expansion from 11-18 years to 8-21 years, nearly doubling market opportunity.
Insurance Coverage: Increased covered lives from 4 million to approximately 51 million, with ongoing efforts to secure additional payers.
Category 1 CPT Code: Achieved a permanent Category 1 CPT code effective January 1, 2026, facilitating easier billing and reimbursement.
FDA Milestones: Received FDA clearance for RED, a device for pelvic floor dysfunction, and submitted for expanded indication for functional dyspepsia.
Revenue Growth: Expect significant revenue growth as national insurance coverage and Category 1 CPT code take effect.
Financial Projections: Revenue in Q4 2024 was $761,000, up 43% YoY; FY 2024 revenue was $2.7 million, up 9% YoY.
Gross Margin: Maintained gross margin of 86.4% in Q4 2024, with expectations for improvement post-2026.
Cash Flow Breakeven: Goal to reach cash flow breakeven based on sales volume and insurance coverage expansion.
Operational Outlook: Anticipate continued revenue growth in Q1 2025, marking the third consecutive quarter of growth.
Category 1 CPT Code: A permanent billing code effective January 1, 2026, facilitating easier revenue cycle management and reimbursement.
Insurance Coverage: Increased from 4 million covered lives to approximately 51 million covered lives, indicating significant growth in insurance policy coverage.
Financial Assistance Program: Provides discounts to patients without insurance, impacting revenue but expected to transition to full reimbursement with the Category 1 CPT code.
Revenue Growth: Fourth quarter 2024 revenue was $761,000, up 43% from $531,000 in Q4 2023, with unit sales increasing approximately 45%.
Gross Margin: Maintained at 86.4% in Q4 2024, with expectations of improvement as the Category 1 CPT code takes effect.
Operating Loss: Reduced to $1.5 million in Q4 2024, a 10% improvement compared to Q4 2023.
Net Loss: Decreased to $1.5 million in Q4 2024, down 73% from $5.3 million in Q4 2023.
The earnings call reveals mixed sentiments. Basic financial performance shows revenue growth but also increased losses and expenses. Product updates, like the RED launch, face adoption challenges, and there's uncertainty in market strategy due to reliance on the new CPT code. The Q&A highlights cautious optimism but lacks concrete details, leading to investor uncertainty. Despite positive long-term prospects, short-term hurdles and management's vague responses temper enthusiasm. Overall, the sentiment remains neutral, expecting minimal stock price movement in the short term.
The earnings call revealed strong revenue growth (39% in Q1 2025) and a significant increase in unit sales (58% YoY), despite a slight decline in gross margin. Operating expenses and losses decreased, showing improved cost management. The Q&A highlighted positive responses from insurance payers and potential for expanded insurance coverage, which could boost future sales. While there are uncertainties in policy writing speed and coverage timelines, the overall sentiment is positive due to revenue growth, cost management, and optimistic insurance coverage outlook.
The earnings call reflects strong financial performance, with a 25% revenue increase and improved margins, alongside positive product development updates. The Q&A highlights significant market expansion opportunities and favorable insurance coverage impacts. Concerns exist regarding regulatory risks and competitive pressures, but the company has a solid plan for growth and breakeven achievement. Overall, the sentiment is positive, indicating a likely stock price increase in the short term, despite some risks.
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