Occlutech Q3 2023 – Achieving continued growth across geographies and sales channels with a positive outlook for year end

Sabine Bois, CEO, comments on Q4 report 2023:

Following a promising first two quarters, I am happy to report that we have maintained good momentum in Q3 underpinned by balanced growth in all key markets and product lines. We are now focused on ensuring that our clinical and supply chain strategies support our profitability targets. A vibrant congress season and new product rollouts alongside our planned US launch and IPO provide much reason for optimism.

Diversified growth in all key markets and regions
Revenue for Q3 2023 increased by 9.7 percent, totaling EUR 8,260 thousand (7,530). Importantly, we see balanced and sustained growth in all key markets and regions, with the exception of Eastern Europe which continues to be affected by the ongoing impacts of the war. Such figures provide confidence regarding our aims to consolidate profitability in the mid-term following a period of significant investment and structural transformation.

Striving forward with an optimized clinical strategy
We are proceeding in our ongoing clinical studies. This includes the OCCLUFLEX (PFO) trial that continues to progress well, with US approval targeted for 2026. At the same time, we have also made some important adjustments to our clinical strategy – namely, ending enrolment early for our FROST HF AFR study in the US. The AFR device is a muchappreciated device and we have treated over 450 patients with lifechanging results. Our clinical and commercial efforts in Europe based on the existing CE mark will continue. In the US, however, we believe it will be beneficial to conduct a strategic review in H1 2024 after the expected competitor results are published to determine the direction for our clinical strategy. This approach will enable us to potentially re-engage in a more focused and less resource intensive study into heart failure in this market to reach earlier profitability. Further, we have also seen a pull from US authorities for some additional indications for the AFR which could facilitate easier entry – something we will continue to investigate.

Increasing emphasis on product rollouts
Much of our current focus is on increasing revenue by gaining market share and introducing new products. This includes a continuing emphasis on rolling out our new delivery system ODS III – a well-designed product that we developed to address customer feedback. We are very satisfied with the response from the market and the successful roll out, marking an important step for us in delivering first-in-class accessories to physicians worldwide.

Anticipated back-order relief in Q4
Alongside these important clinical and product activities, we have also been working on our supply chain strategy to improve consistency and reliability moving forward. We continued to experience some shortages in Q3, largely because of the slow response times of notified bodies in the MDR certification process of some accessories. However, having now received two important approvals, we are expecting a relief during Q4. One of our suppliers has also been the subject of production impacts – an issue that we’re working with them to resolve, with mid term ambitions to diversify our sourcing strategy.

A productive congress season
Congress season has also been a major focus for the quarter, with momentum continuing after summer thanks to SOLACI congress in Brazil, where we had significant presence and a successful distributor meeting with our partner in Latin America. This was followed by the PICS World Congress in Washington in September where we were proud sponsors of the Fellows dinner and had productive interactions with physicians and distributors alike, together with our US partner B. Braun Interventional Systems. These key events were supplemented by involvement in several local congresses in key regions that also provided the opportunity to hold progressive meetings with distributors.

Eyeing the US launch and IPO
Looking ahead, we are now finalizing logistics and training plans for the US launch of our ASD Occluder to ensure that commercialization can be kickstarted immediately as soon as approval is granted (anticipated for H1 2024). We are also continuing on our IPO readiness path, having furthered our journey for the Stockholm NASDAQ main list over the past year with internal preparations. The final piece of this entails the completion of SAP implementation, which is scheduled for the end of this year.

Undoubtedly, there are exciting times ahead. Thanks to the incredible Occlutech team that is fully committed to realizing these progressive ambitions.

As always, thank you for your continued support in enabling this journey!

Sabine Bois