Ondine Biomedical (OBI) H1 2024 earnings summary

Executive summary

• Achieved 100% year-over-year revenue growth in H1 2024, driven by rapid hospital adoption, new indications, and expansion into the UK, Spain, and Australia.

• Entered a strategic global partnership with Mölnlycke Health Care to accelerate commercialization and market reach, especially in EMEA.

• Preparing for a pivotal US phase 3 clinical trial with HCA Healthcare, targeting FDA approval for surgical site infection reduction.

• Launched a second clinical indication for ICU patients, with a milestone-driven, equity-based study at Royal Columbian Hospital.

• Ondine Biomedical develops and commercializes antimicrobial photodynamic therapy (aPDT) products as alternatives to antibiotics, with operations in Canada, US, UK, Barbados, and Switzerland.

Financial highlights

• Revenue for H1 2024 was $0.86M, up 101% from H1 2023, with gross margin improving to $0.53M and gross margin percentage rising to 62% from 59%.

• Net loss narrowed to $7.76M from $7.90M in H1 2023.

• G&A costs decreased by 10% versus H1 2023, while R&D costs rose by 51% due to phase 3 trial preparations.

• Sales and marketing expenses halved as the company streamlined operations and leveraged KOL networks.

• Cash and restricted cash at June 30, 2024 totaled $1.37M, down from $4.59M at June 30, 2023.

Outlook and guidance

• Anticipates continued rapid revenue and hospital growth, supported by the Mölnlycke partnership and new market entries.

• Expects the US phase 3 trial to complete within 6–9 months, with FDA approval targeted soon after.

• Management believes existing cash, operations, and anticipated financings will provide sufficient liquidity for at least the next twelve months.

• The company expects to continue raising funds through public or private equity and/or debt financings.

• ICU indication study in Canada to inform broader regulatory submissions and commercialization in EU and US.