Neola Medical (NEOLA) Q4 2024 earnings summary

Executive summary

• 2024 marked a strategic shift from technical to clinical phase, with key milestones including approval to initiate the first clinical pilot study on preterm babies in Sweden and successful Human Factors Validation Study in the U.S.

• The company is commercializing a Class II neonatal lung analyzer, targeting preterm-born infants, with a strong U.S. market focus and collaborations with key opinion leaders.

• Strengthened IP position with new patents in the U.S. and Europe and obtained U.S. trademark registration for Neola®.

• Recognized as a leading innovator in pediatric medical technology, winning a silver medal at the Stanford PDC Accelerator Pitch Competition and participating in the Stanford Impact1 program.

Financial highlights

• Operating revenue for 2024 was SEK 10,392k, up from SEK 9,830k year-over-year.

• Operating expenses increased by SEK 1.8 million year-over-year, totaling SEK 19.6 million for 2024.

• Operating result for 2024 was SEK -10,797k, compared to SEK -9,621k in 2023.

• Cash flow for the year was SEK -2,022k, a significant improvement from SEK -18,512k in 2023.

• Earnings per share for 2024 were SEK -0.14, compared to SEK -0.17 in 2023.

Outlook and guidance

• Preparing for the first clinical pilot study in Sweden, with results to inform a pivotal U.S. clinical study and FDA application.

• Plans to submit documentation for FDA and CE marking by 2026, with approvals expected in 2026/2027.

• Burn rate expected to increase as clinical validation accelerates and commercial preparations expand.

• Next quarterly report scheduled for April 9, 2025.