aap Implantate AG
Sales growth Q2/2024 +14 % and H1/2024 +10 % compared to previous year; positive development in all operating areas

• Sales: Q2 at EUR 3.3 million (+14% yoy), main growth driver EMEA (Q2: +44%);
• Sales: H1/2024 increased by 10% to EUR 6.4 million compared to H1/2023;
• The human clinical trial of the innovative antibacterial implant technology has so far recruited 200 patients, and aap has applied to complete patient recruitment;

aap Implantate AG (“aap” or “Company”) continued its growth in the second quarter. In the EMEA region, aap was able to significantly increase the overall result for the first half of the year, mainly due to an order from an aid organization in the second quarter. At the same time, existing markets such as Spain/Portugal (+41% yoy), South Africa (+9% yoy) and smaller countries in the Middle East achieved up to double-digit growth rates.

The effects of the reorganization in the USA, which were highlighted in the first quarter, could not be offset in the second quarter, meaning that sales were down 22% on the previous year in the first half of the year. Positive developments in customer acquisition as well as a well-filled project pipeline make the Management Board confident that this decline can be made up for over the course of the year through the continued focused work of the reorganized and growing team.

In Latin America, after a strong first quarter, which was primarily characterized by investments in aap systems to equip new customers, growth continued in the second quarter. In addition to Brazil (+67% yoy) and Mexico (+23% yoy), aap‘s largest sales markets, other markets such as Colombia (+39% yoy) also grew in terms of sales. In the APAC region, the customer base was expanded to include new customers, meaning that further future growth is expected in the region.

Q2/2024 – Turnover

Half-year 2024 – Turnover

The company is making great progress in the ongoing human clinical trial with the antibacterial implant technology and has recruited 200 patients to date. Due to the continued very positive progress of the study, aap applied to the approving body to be able to complete patient recruitment in mid-2024. If approved, the 12-month follow-up phase with the last patient included could be completed earlier than originally planned.

At the beginning of July, aap received the positive news that the first hurdle in the application for funding and investment under the European Horizon program (EIC Accelerator) had been successfully overcome and that the company could submit a full application for its antibacterial implant technology in a further step. A positive assessment of the full application would open the possibility that the European Investment Bank could invest in aap in 2025 and provide significant support for the investments required for the transformation.

The German Federal Ministry of Education and Research (“BMBF”) is funding the clinical study. The grant awarded to the company (funding codes 13GW0313A+B, 13GW0449A+B) is part of the BMBF’s “Healthcare industry in the healthcare research framework program” (= funding body). According to the BMBF, funding is provided for projects on the topic of “Transferring medical technology solutions to patient care – proving clinical evidence without delay”. For further information, please refer to the relevant guidelines on the BMBF website: https://www.bmbf.de/foerderungen/bekanntmachung-1376.html.

The company also made significant progress towards MDR approval. In the first few months, all main product files required for the MDR were submitted to the notified body. A first main product file was positively reviewed by the notified body in accordance with the MDR at the end of June. The company remains committed to its plan to complete MDR approval by the end of 2024 and thus launch new products on the CE market in 2025.

As part of aap‘s further product development activities, the company also received US FDA approval for its double-threaded compression screws in the first half of the year and can begin preparations for market launch activities in the United States and other markets that accept FDA approval for 2025 in the second half of the year.

The detailed half-year report will be published on August 14, 2024.




 

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aap Implantate AG (ISIN DE0005066609) – General Standard/Regulated Market – All German stock exchanges –

About aap Implantate AG

aap Implantate AG is a globally active medical technology company based in Berlin, Germany. The company develops, produces and markets products for traumatology. The IP-protected portfolio includes the innovative anatomical plate system LOQTEQ® and a wide range of cannulated screws. In addition, aap Implantate AG has an innovation pipeline with promising development projects such as antibacterial silver coating technology and magnesium-based implants. These technologies address critical problems in traumatology that have not yet been adequately solved. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups and group clinics, while internationally it primarily uses a broad network of distributors in around 25 countries. In the United States, the company relies on a sales strategy via distribution agents through its subsidiary aap Implants Inc. The aap Implantate AG share is listed in the General Standard of the Frankfurt Stock Exchange (XETRA: AAQ.DE). For further information, please visit our website at www.aap.de.

The figures presented in this press release may be subject to technical rounding differences that do not affect the overall picture.

Forward-looking statements

This release may contain forward-looking statements that are based on the current expectations, assumptions and forecasts of the Executive Board and information currently available to it. The forward-looking statements are not to be understood as guarantees of the future developments and results mentioned therein. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual results, financial situation, development or performance of the company and the estimates given here. These factors include those that aap has described in published reports. Forward-looking statements therefore speak only as of the date on which they are made. We assume no obligation to update the forward-looking statements made in this release or to conform them to future events or developments.

If you have any questions, please contact: aap Implantate AG; Rubino Di Girolamo, Chairman of the Management Board/ CEO, Lorenzweg 5; 12099 Berlin

Phone: +49 (0)30 75019 – 170; Fax: +49 (0)30 75019 – 290; Email: r.digirolamo@aap.de