What is the revenue and EPS growth rate for Spectral AI year over year?

What does Spectral AI do and what are its main business segments?

What were the key takeaways from Spectral AI's earnings call?

What guidance did Spectral AI's management provide for the next earnings period?

What is Spectral AI's gross profit margin?

Did Spectral AI beat or miss consensus estimates last quarter?

What is Spectral AI's latest dividend and current dividend yield?

What is the market's earnings forecast for Spectral AI next quarter?

- **Cash Position Solid**: $10.5 million cash on hand, bolstered by $7.6 million funding, supporting 2025-2026 operations.
- **FDA Approval On Track**: Despite government shutdown delays, FDA interactions remain productive, targeting H1 2026 clearance.
- **Revenue Adjustment**: 2025 revenue guidance reduced to $18.5 million, with 2026 expected to mirror 2025 levels.
- **Commercial Momentum**: Hiring 4 FTEs for U.S. launch, leveraging international success (U.K., Australia) to drive adoption.
- **Innovation Pipeline**: Handheld device development funded by military, with potential civilian applications post-launch.

**【Management Opening Remarks】**
- **Financial Stability**: Cash balance remained at $10.5 million, with an additional $7.6 million from a registered direct offering, providing sufficient capital for 2025-2026 operations.
- **FDA Progress**: Submitted FDA de novo application in June 2025, facing delays due to the U.S. government shutdown but maintaining focus on first-half 2026 approval.
- **Commercialization Readiness**: Planning U.S. launch of DeepView system, with international units in the U.K. and Australia receiving positive feedback, including ease of use and clinical benefits.

**【CFO Financial Commentary】**
- **Revenue Decline**: R&D revenue dropped to $3.8 million (Q3 2025) from $8.2 million (Q3 2024) due to reduced BARDA contract activity post-FDA submission.
- **Profitability Challenges**: Net loss widened to $3.6 million (Q3 2025) from $1.5 million (Q3 2024), driven by higher G&A expenses and lower reimbursements.
- **Guidance Update**: Reduced 2025 revenue guidance to $18.5 million (from $21.5 million), anticipating partial recovery in 2026 post-government shutdown resolution.

**【Q&A Highlights】**
- **FDA Interactions**: Despite delays, ongoing productive dialogue with FDA; statistical analysis plan (SAP) for AI algorithm received favorable feedback.
- **Handheld Device Development**: Military-funded handheld module in testing phase, with potential civilian application post-FDA clearance.
- **Commercialization Strategy**: Hiring 4 FTEs for 2026 to support sales and education, leveraging BARDA funding for burn center placements.
- **International Expansion**: Positive feedback from U.K. units; planning CE Mark and UKCA clearance for European market entry.
- **IP Transaction**: Spectral IP acquisition expected to close in Q1 2026, enhancing intellectual property portfolio.

Spectral AI, Inc. (MDAI) Q3 2025 Earnings Call Transcript

- **FDA Progress**: Q2 2025 de novo submission for DeepView System, targeting H1 2026 FDA clearance with BARDA support.
- **Financial Strength**: $10.5M cash, $15M debt facility, and reduced operating expenses support 2025 revenue guidance of $21.5M.
- **Commercialization Plan**: BARDA collaboration to accelerate U.S. launch, with potential expansion into non-burn wound applications.
- **Risk Management**: Net loss driven by warrant liability, but 6-month loss down 16% YoY through cost control.

**【Management Opening Remarks】**
- **FDA Submission Milestone**: Completed de novo application for DeepView System in Q2 2025, with pre-submission meetings aligning with FDA expectations. 
- **Financing Update**: Secured $15M debt facility (initial $8.5M draw) and $2.7M equity raise, providing $10M+ cash runway. Second $6.5M debt tranche contingent on FDA approval.
- **BARDA Collaboration**: BARDA funding supports commercialization, with potential device purchases post-clearance. Exploring second clinical indication beyond burns.
- **Spectral IP Subsidiary**: Preparing for IPO, but no impact on core operations or resources.

**【CFO Financial Commentary】**
- **Revenue Performance**: Q2 R&D revenue $5.1M (-32% YoY) due to reduced BARDA reimbursements. Gross margin 45.2% (-1.4% YoY) from lower reimbursed expenses.
- **Cost Management**: G&A expenses down 24% YoY to $4.4M, driven by operational efficiency. Net loss $7.9M (+169% YoY) due to warrant liability, but 6-month loss down $1M YoY.
- **Balance Sheet**: Cash $10.5M (vs. $5.2M end-2024). 2025 revenue guidance $21.5M, excluding potential UK/Australia sales.

**【Q&A Highlights】**
- **FDA Clearance Timing**: Targeting H1 2026 clearance, with commercialization plan underway. BARDA may assist initial device distribution.
- **Market Expansion**: UK and Australia serving as learning labs, with focus on U.S. launch. Exploring non-burn applications like wound assessment.
- **BARDA Role**: Contract includes funds for commercialization, but specifics subject to regulatory approval. No immediate sales contribution from international markets.

Spectral AI, Inc. (MDAI) Q2 2025 Earnings Call Transcript

- **Strong Financials**: 6% R&D revenue growth, 47.2% gross margin, $14.1M cash
- **FDA Confidence**: 10 pre-sub meetings, 340B data points, 2025 Q2 submission on track
- **Product Momentum**: 2 Snapshot M prototypes, BARDA Phase 2 guidance reaffirmed
- **Cash Runway**: $14M+ liquidity with reduced burn rate


**【CFO Financial Summary】**
- **Revenue Growth**: Q1 2025 R&D revenue rose 6% to $6.7 million, driven by BARDA Project BioShield contract activity.
- **Profitability**: Gross margin improved to 47.2% (vs. 46.6% Q1 2024). Operating loss narrowed to $896k (vs. $2.1M prior year). Net income reached $2.9M.
- **Cash Position**: $14.1M cash on hand (up from $5.2M) via $15M debt facility and $2.7M equity raise.
- **Burn Rate**: Reduced G&A expenses to $4.1M (down 20% YoY), creating >$14M cash runway.

**【FDA Submission Progress】**
- On track for Q2 2025 De Novo submission with:
  - 10+ pre-sub meetings with FDA
  - 340B validated data points from Burn Validation Study
  - Statistically superior performance vs. physician judgment
- BARDA partnership provides regulatory guidance and non-dilutive funding

**【Product Development】**
- **DeepView Snapshot M**: 2 prototypes completed, targeting 2027 military deployment
- **MTEC Contract**: Advancing AI integration for total body surface area measurement
- **BARDA Phase 2**: $21.5M 2025 revenue guidance excludes international sales

**【Spectral IP Subsidiary】**
- Focused on healthcare IP monetization
- No core assets or capital required from parent company
- Awaiting SEC registration for IPO


Spectral AI, Inc. (MDAI) Q1 2025 Earnings Call Transcript

- **Breakthrough Burn Diagnostics**: DeepView outperformed clinicians with 86.6% sensitivity and 68.5% Dice Score, setting 2026 FDA De Novo target.
- **Global Expansion Momentum**: 3 DeepView units deployed in Australia; U.K. partnerships driving real-world clinical validation.
- **Financial Strength**: $14M+ cash post-Avenue financing; 2024 R&D revenue up 63.5% to $29.6M, gross margin 44.9%.
- **Strategic Priorities**: 2025 focused on FDA submission and BARDA deployment; SnapShot M targeting 2027 military rollout.

**【CEO Key Updates】**
- **Burn Validation Study Success**: Achieved 86.6% sensitivity in identifying non-healing tissue vs. 40.8% for clinicians, with Dice Score of 68.5% vs. 39.2%. FDA submission planned by Q2 2025 for De Novo classification in 2026.
- **International Deployment**: 3 DeepView systems deployed in Australia (Sydney, Adelaide, Perth) under special access scheme; U.K. partnerships show strong clinical adoption.
- **SnapShot M Development**: $7M+ government funding, with $850K recent grant. Targeting 2027 military deployment for battlefield triage.
- **Spectral IP Spin-Off**: Monetizing 30+ patents via SIM IP, with $1M initial investment. Spin-off expected within 90 days, subject to approvals.

**【CFO Financial Highlights】**
- **Q4 2024 Results**: R&D revenue $7.6M (vs. $5.3M prior year), driven by BARDA PBS contract. Full-year R&D revenue $29.6M (+63.5% YoY). Gross margin 44.9% (vs. 43.6% prior year) due to higher BARDA reimbursement rates.
- **Cash Position**: $5.2M as of Dec 31, 2024. Post-Avenue Capital financing, cash exceeds $14M. 2025 revenue forecast $21.5M (excluding U.K./Australia commercial contributions).
- **Cost Efficiency**: Monthly operating losses reduced from $4.6M (H1 2024) to $2M (H2 2024). $10.1M short-term debt satisfied in Feb 2025.

**【Q&A Key Takeaways】**
- **Commercialization Strategy**: No immediate salesforce needed for U.S. due to BARDA deployment; focus on real-world evidence from U.K./Australia for FDA submission. 2025 seen as transition year before 2026 commercial launch.
- **FDA Submission Progress**: 14-section application under review by BARDA before FDA. Pediatric and adult data merged into single dataset for analysis.
- **SnapShot M Milestones**: Ruggedness testing and military feedback integration in 2025; next funding tranche expected in 2026 for austere environment deployment.
- **U.K./Australia Learnings**: Positive feedback on DeepView's accuracy vs. laser Doppler imaging. Coding and care paradigm changes needed for U.S. adoption.

MDAI

MDAI fundamentals

Earnings Call

You can ask Aime