Full Year 2025 ONWARD Medical NV Earnings Call & Business Update Transcript
Key Points
- Onward Medical NV (ONWRF) successfully introduced a new technology, penetrating 80 clinics in its first year on the market.
- The company achieved significant regulatory milestones, including earning a 510(k), an IDE, and a CE Mark.
- Onward Medical NV (ONWRF) recorded EUR5.4 million in revenue, with strong sales of the ARC-EX systems in both the US and Europe.
- The company raised over EUR50 million in equity capital, strengthening its financial position.
- Onward Medical NV (ONWRF) advanced its pipeline with FDA IDE approval for the EMPOWER BP pivotal study and published significant clinical data in prestigious journals.
- Total operating expenses increased to EUR45.3 million, reflecting higher costs in several areas, including US commercial operations and recruitment.
- The company reported a net loss of EUR41.8 million for 2025, up from EUR35.7 million in 2024.
- There is uncertainty regarding the timing and execution of a potential Nasdaq IPO, dependent on market conditions and revenue predictability.
- The company faces challenges in establishing distribution channels in certain European countries, such as France.
- Onward Medical NV (ONWRF) is still in the early stages of understanding demand drivers for home use sales outside the VA system, with self-pay being an unknown factor.
Ladies and gentlemen, thank you for standing by. Welcome to the ONWARD Medical full-year 2025 financial results and business update. (Operator Instructions) Please be advised that today's conference is being recorded.
I would like now to turn the conference over to Sebastien Cros, Vice President of Communications. Please go ahead.
Thank you, Michel. Good morning, good afternoon, everyone, and welcome to ONWARD's webcast following the publication of our full-year results earlier today. Before we get started, as usual, please take a moment to read our disclaimer.
Today's presentation includes forward-looking statements, which should be considered with the appropriate level of caution as outlined on this page. This presentation and a recording of the webcast will be made available on our investor website after the call.
With us today are three members of ONWARD's leadership team; David Marver, CEO; Ali Kiboro, our CFO; and Shari O'Quinn, Chief Clinical, Regulatory, and
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