• Sales: EUR 2.9 million (+6 % yoy); EMEA (+19 % yoy) and North America (+5 % yoy) as main growth drivers
• EBITDA: EUR -0.5 million (Q1/2021: EUR -0.2 million) impacted by planned build-up of sales infrastructure and conduction of human clinical study
• Silver: First surgeries performed as part of human clinical study for innovative silver antibacterial coating technology

aap Implantate AG ("aap" or the "Company") started the financial year 2022 in a challenging macroeconomic environment with solid sales growth and EBITDA in line with expectations. In this context, aap increased sales by 6 % compared to the same period of the previous year to EUR 2.9 million (Q1/2021: EUR 2.7 million). In terms of earnings, the Company recorded EBITDA of EUR -0.5 million (Q1/2021: EUR -0.2 million), which mainly reflects the planned expansion of the sales infrastructure in Germany and the U.S. and the conduction of the human clinical study for aap's innovative antibacterial silver coating technology.

Q1/2022 - Key financial figures

Sales

Overall, the picture is ambivalent when looking at the individual regions: the pleasingly significant growth in the EMEA region (= Europe, Middle East, Africa; +19 %) is mainly based on a revival of business with existing customers in Southeastern Europe and the Middle East. In contrast, the recovery to pre-COVID-19 levels in the individual markets of importance to the Company, Spain and Germany, is taking notably longer than expected and planned, which is reflected above all in a continued lower case volume than before the onset of the COVID-19 pandemic.

In North America, aap remains on a growth track and was able to increase sales (+5 %). After a very slow start in January and the first half of February due to COVID-19 effects, March saw the highest ever number of surgeries performed in a single month.

In Latin America (-26 %) and Asia-Pacific (-34 %), the ongoing impact of the COVID-19 pandemic is clearly reflected. Rising infection rates and zero COVID19 guidelines implemented in some regions impacted business performance in the first months of the fiscal year, in some cases severely. In addition, new regulatory and procurement guidelines that came into force at short notice, particularly in China, are making further expansion of the business more difficult.

EBITDA

• Sales level realized in the first quarter below the Company's planning mainly due to the aforementioned effects from the COVID-19 pandemic and the war in Ukraine,
• Stable high gross margin (in %) with increase in gross margin^[1] in absolute figures (approx. +EUR 100 thousand) in connection with realized sales growth in Q1/2022,
• Planned increase in personnel expenses mainly due to the expansion of the sales infrastructure in Germany and the USA to implement the planned sales growth, as well as in the areas of quality management, regulatory and clinical affairs to ensure certification in accordance with the new EU Medical Device Regulation (MDR 2017/745/EU) within the transitional period until 2024 as planned
• Stable cost level (excluding non-recurring effects) in other costs in the operating trauma business incl. central administration functions,
• Cost increase from conducting the human clinical study of aap's innovative silver coating technology with the first surgeries performed and the inclusion of further clinics participating in the study in the first quarter of 2022,
• Lower non-recurring effects that had an earnings-enhancing impact on EBITDA in the first quarter of 2021 (mainly from the recognition of income from COVID-19 support programs).

Excluding the non-recurring effects, recurring EBITDA decreased to EUR -0.4 million in the first quarter of 2022 (Q1/2021: EUR -0.2 million).

Silver coating technology

With regard to aap's innovative silver coating technology, the first surgeries in the human clinical study for its innovative antibacterial silver coating technology were performed in the first quarter of 2022. The surgeries took place at the University Hospital Regensburg and went according to plan. In addition, the Company was able to include further clinics in the study in the first quarter, so that further patient recruitment can be expected in the coming months. aap had initiated the clinical human study in December last year, which is an essential step towards the planned market approval (CE) of the innovative technology.

Outlook

Despite the currently observable dynamic pressure on global supply chains, the uncertainty regarding the COVID-19 pandemic as previously described, the general inflationary environment and taking into account the first quarter results, the Management Board continues for the time being to adhere to the communicated forecast values for sales and EBITDA for the financial year 2022. Even under the current market adversities, the Company is recording a growing number of new potential distribution channels and aap's long-standing distribution partners are confident that they will return to pre-pandemic levels in the foreseeable future. In this context, aap's distribution partners and the Company anticipate a renewed increase in case numbers in the trauma segment due to observable declines in COVID-19 infection figures, a resurgence in global mobility as a result of increased return to work, increased sports and leisure activities, and a resurgence in numbers in the tourism industry.



^[1] Gross margin = sales revenue +/- change in inventories of finished goods and work in progress - cost of materials / cost of purchased services
 

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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, manufactures and markets products for traumatology. In addition to the innovative LOQTEQ® anatomical plate system, the IP-protected portfolio includes 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 at international level it primarily uses a broad network of distributors in around 25 countries. In the USA, the company relies on a hybrid sales strategy through its subsidiary aap Implants Inc. This involves sales both via distribution agents and as part of partnerships with global orthopedic companies. 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 https://www.aap.de/

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

Forward-looking statements
This release may contain forward-looking statements based on current expectations, beliefs and projections of the Management Board and currently available information. The forward-looking statements are not guarantees of future performance or results. Various known and unknown risks, uncertainties and other factors could lead to material differences between the actual future results, financial situation, development or performance of the company and the estimates given here. These factors include those discussed in aap's public reports. Forward-looking statements therefore speak only as of the date 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.