- Sales of EUR 9.3 million in a COVID-19-driven FY/2020 in upper half of guidance of EUR 8.0 to 10.0 million (FY/2019: EUR 11.7 million)

- Q4/2020 sales at EUR 2.4 million (Q4/2019: EUR 3.1 million); all markets except USA again strongly impacted by comprehensive lockdown measures in context of COVID-19 pandemic

- USA: Continued dynamic sales growth with +36% in Q4/2020 and +41% in FY/2020; in Q4/2020 target sales of
USD 1 million/quarter with USD 0.9 million almost reached for first time

- Outlook FY/2021: Assuming an easing of COVID-19 situation from Q2/2021 onwards significant sales growth (+29 to +61%) and positive EBITDA in trauma business planned - guidance with sales of EUR 12.0 to 15.0 million and EBITDA of EUR -5.5 to -3.5 million (EUR -2.8 to -0.8 million excl. R&D project costs for silver coating and resorbable magnesium implant technology)

- Financing: Focus in Q1/2021 on securing financing; implementation of further measures to finance planned growth and further development of key technologies

- Restructuring: Further double-digit percentage reduction in manufacturing costs planned through efficiency improvements in production process and continued strict cost discipline

- Silver coating technology: Start of human clinical study in Germany planned for FY/2021 - third party co-financing of study aimed and further collaboration opportunities under evaluation

- Resorbable magnesium implant technology: Securing financing for further development and start of GLP animal study in USA planned for FY/2021 - promising discussions with various investors underway

Sales development FY/2020 and Q4/2020

According to preliminary figures, aap Implantate AG ("aap") achieved sales of EUR 9.4 million (FY/2019: EUR 11.7 million) in a financial year 2020 marked by COVID-19, which is in the upper half of the guidance of EUR 8.0 million to EUR 10.0 million. In the fourth quarter of 2020, sales were EUR 2.4 million (Q4/2019: EUR 3.1 million) and, after the first recovery trends in the third quarter, were again strongly impacted by the comprehensive lockdown measures in the context of the COVID-19 pandemic, which were recently even tightened in some cases.

Sales FY/2020

Sales Q4/2020

A look at the sales development in the individual regions shows that in the fourth quarter of 2020, with the exception of the USA, all of aap's main markets continued to be affected by the impact of the COVID-19 pandemic. Accordingly, the Company recorded a year-on-year decline in sales both in Germany (-28%) and in international business (-39%) in the fourth quarter. The pandemic-related impairments were particularly noticeable with respect to aap's very important foreign business (excluding the USA; around 60% of total sales in financial year 2019 with the biggest customers from Spain, South Africa, Brazil and Mexico). Furthermore, tenders in which aap is participating and has sometimes already received commitments via its distributors have been postponed until the first quarter of 2021.
 

The same applies to the sales development in the individual markets (with the exception of the USA) in the entire financial year 2020, which was primarily shaped by the lockdown measures in the first half of the year and the fourth quarter in the context of the COVID-19 pandemic.
 

In the USA, on the other hand, aap remains on a dynamic growth course and was able to significantly increase sales again in the fourth quarter of 2020 year-on-year (+36%; taking into account constant exchange rates +49%). The Company has thus almost reached its target sales of USD 1 million/quarter for the first time with USD 0.9 million in the fourth quarter of 2020. As a result, aap recorded a significant year-on-year increase in sales of +41% (taking into account constant exchange rates +44%) despite the COVID-19 pandemic that was particularly rampant in the USA. This increase in sales is primarily based on a massive expansion of the customer base and the contracts concluded with US-wide purchasing associations and networks. Overall, the positive sales development in the USA was able to mitigate the COVID 19-related sales declines in the other markets.

 

Outlook 2021

In addition to the significant effects of the COVID-19 pandemic, aap's financial year 2020 was largely characterised by extensive restructuring and refinancing. In this context, the Company was able to make tangible progress in the restructuring process, which, despite the enormous challenges posed by COVID-19, is reflected, among other things, in dynamic sales growth in the USA (+41% vs. FY/2019), an increased gross margin and a significantly reduced cost level. In addition, aap was able to successfully implement the first two steps of the refinancing with a capital reduction and the issuance of a convertible bond.
 

In the first quarter of 2021, the focus will remain on securing the Company's further financing. Based on the visible progress in restructuring, aap intends to implement further measures to ensure the continuity of the Company and to finance the planned growth as well as the further development of the key technologies. The financing measures currently under consideration range from equity-based transactions via the capital market (e.g. capital increase) to out-licensing or targeted financing for the two platform technologies antibacterial silver coating and resorbable magnesium implants, as well as the sale of assets (e.g. land). With a view to restructuring, the Company intends to further increase efficiency in the production process and thus reduce manufacturing costs by a double-digit percentage. Furthermore, aap continues to impose strict cost discipline throughout the Company.
 

Assuming that the COVID-19 situation eases from the second quarter onwards, aap aims to return to the growth path in the financial year 2021. The Management Board expects sales of EUR 12.0 to EUR 15.0 million, which corresponds to a significant growth rate of +29 to +61%. All markets are expected to contribute to the planned sales growth, with the USA acting as the main growth driver. The planned increase in sales in the USA is to be achieved not only by expanding business with existing customers through product portfolio extensions but also by newly acquired customers and, in particular, the concluded contracts with US-wide purchasing associations and networks. Against the backdrop of the still rampant COVID-19 pandemic and the latest comprehensive lockdown measures, some of which have even been tightened recently, the Company expects that the first quarter of 2021 will still be severely affected by COVID-19. As the population's vaccination coverage continues to progress, the Board expects business to recover in the second quarter, also against the backdrop of rising temperatures and increased outdoor human activity, before significant growth is anticipated from the third quarter onwards.
 

With regard to earnings, the Management Board expects EBITDA for the financial year 2021 to be between EUR -5.5 and EUR -3.5 million. Excluding R&D project costs for the silver coating and the resorbable magnesium implant technology, the projected values for EBIDTA are between EUR -2.8 and -0.8 million. In the operative trauma business, the Company aims to achieve positive EBITDA in the current financial year for the first time since focusing on trauma in 2016.
 

In the area of its innovative silver coating technology, aap carried out, among other things, test coatings for first joint development projects potentially to be completed with various medical technology companies in financial year 2020. Overall, technology and product development for the human clinical study has been completed and all regulatory requirements (BfArM and ethics commissions approvals) for the start of the trial in Germany have been fulfilled. Against the backdrop of the COVID-19 pandemic, aap plans to start the study in financial year 2021, initially in individual hospitals and then successively expand it to all participating hospitals in Germany. Furthermore, the active exchange with the FDA (= Food and Drug Administration) will be continued in order to ensure that all the necessary prerequisites for the prompt release of a clinical trial in the USA are met and that approval can subsequently be obtained. In principle, aap continues to strive for potential co-financing of the human clinical study by third parties and is also evaluating further cooperation possibilities. Against this background, a new subsidiary, MCTeQ GmbH (= Medical Coating Technologies), was founded at the end of the 2020 financial year, into which the silver coating technology is to be incorporated. This will make it possible to manage the technology in a more flexible and targeted manner and to implement the desired co-financing.
 

With a view to its innovative resorbable magnesium implant technology, aap was able to make significant progress in financial year 2020. The results from the pilot animal study carried out with Colorado State University indicate that the degradation process of the implants can be controlled as desired and that the bone heals according to plan, thus providing a "proof of concept" for the technology. In addition, the FDA (= Food and Drug Administration) has confirmed that aap's technology is likely to be classified as a so-called particularly innovative "novel" technology and qualifies for a "de novo" approval way. In financial year 2021, aap wants to secure the financing of the further development of the resorbable magnesium implant technology and is currently in promising discussions with various investors in this context. After the financing has been secured, the next step is to start the planned GLP animal study in the USA.
 

The sales figures contained in this press release are preliminary figures as of 31 December 2020, which are subject to change until final publication. aap plans to announce the final audited results for the financial year 2020 on 31 March 2021 as part of the consolidated annual financial report 2020.


^[1] The disclosure of the other sales revenues still reported in the previous year is no longer applicable and is now allocated to the individual regions.

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aap Implantate AG (ISIN DE0005066609) - General Standard/Regulated Market - All German stock markets -

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 trauma. The IP-protected portfolio includes besides the innovative anatomical plating system LOQTEQ(R) a wide range of cannulated screws. In addition, aap Implantate AG has an innovation pipeline with promising development projects such as the antibacterial silver coating technology and magnesium-based implants. These technologies address critical and unmet needs in trauma. In Germany, aap Implantate AG sells its products directly to hospitals, purchasing groups, and hospital groups, while at international level it primarily uses a broad network of distributors in around 25 countries. In the US the Company pursues a hybrid distribution strategy with its subsidiary aap Implants Inc. Distribution is carried out both through distribution agents and partnerships with global orthopedic companies. aap Implantate AG's stock is listed in the General Standard segment of Frankfurt Stock Exchange (XETRA: AAQ.DE). For more information, please visit our website at www.aap.de.

Forward-looking statement
This release may contain forward-looking statements based on current experience, estimates and projections of the management board and currently available information. They are not guarantees of future performance. 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. Many factors could cause the actual results, performance or achievements of aap to be materially different from those that may be expressed or implied by such statements. These factors include those discussed in aap's public reports. Forward-looking statements therefore speak only as of the date they are made. aap does not assume any obligation to update the forward-looking statements contained in this release or to conform them to future events or developments.


For inquiries please contact:

aap Implantate AG; Fabian Franke; Manager Investor Relations; Lorenzweg 5; 12099 Berlin, Germany; Phone: +49/30/750 19 - 134; Fax: +49/30/750 19 - 290; Email: [email protected]