• Sales: EUR 11.5 million (-6 % yoy; CER[1] : -9 % yoy); markets generally in difficult environment with mixed results; USA in H2/2022 with solid growth and excluding one-off effects +16 % yoy
• EBITDA: EUR -1.7 million (FY/2021: EUR -0.8 million); operating cash flow +23 % yoy
• Silver: Release revised study protocol in Q4/2022 with restart study in Q2/2023; Ongoing promising clinical data from individual healing trials
• Successful refinancing: approx. 10 % capital increase via strategic investor and shareholder loan; exercise of conversion rights with EUR 1.6 million equity effect
• Outlook FY/2023: Sales between EUR 12.0 and 14.0 million (+4 % to +22 %); EBITDA total company (incl. costs silver coating technology) of EUR -2.5 to -1.7 million

 

aap Implantate AG (“aap” or the “Company”) consolidated its basis and operating business in a particularly challenging financial year 2022. The year started turbulently with the beginning of the war in Europe, subsequent inflation explosion, interest rate hikes and cost explosions for energy sources and raw materials as well as a continuing COVID-19 pandemic situation. The first half of the year left its mark and the Company was unable to achieve the targeted sales increases despite investments in distribution. The second half of the year then showed signs of recovery in markets such as LATAM and the USA, with the result that the last two quarters closed just above the previous year. The sales forecast revised in the summer was achieved with EUR 11.5 million and a slight decline in sales (-6 % y-o-y; FY/2021: EUR 12.2 million). EBITDA deteriorated to EUR -1.7 million (FY/2021: EUR -0.8 million) but remained within the originally forecast range. Despite the deterioration in earnings, aap improved operating cash flow by +23 % year-on-year in FY2022 (FY/2021: EUR -2.5 million). Overall, the trend of previous years towards a positive result and a balanced cash flow in 2022 was thus stopped by the accumulation of external negative events.

 

FY/2022 – Key financial figures

Sales

in EUR million	FY/2022	FY/2021	Change
Sales  EMEA (= Europe, Middle East, Africa) North America*  LATAM (= Latin America) APAC (= Asia-Pacific)	11.5 5.8 3.4 2.0 0.3	12.2 6.4 3.5 1.8 0.5	-6 % -9 % -3 %* +11 % -40 %
Sales	11.5	12.2	-6%

* In North America, two special effects amounting to EUR 0.4 million are to be excluded from the sales comparison. Excluding these non-recurring effects results in growth of +16 % for the fiscal year 2022
 

Looking at the individual regions, sales for fiscal 2022 were ambivalent. In the EMEA region (= Europe, Middle East, Africa; -9 % y-o-y), growth was realized above all in South Africa (+14 % y-o-y) as well as in Israel and smaller European markets, which, however, could not compensate for the development of the central markets such as Spain and Germany, among others, which were below the previous year’s level. In both central markets, the sales measures initiated did not yet lead to a turnaround compared to the pre-COVID 19 level due to staff shortages in hospitals and low trauma cases up to postponements of unnecessary operations.

The picture in the USA is divided: While at first glance there is a decline in sales for the region in fiscal year 2022 (‑ 3 % compared to the previous year), two special effects amounting to EUR 0.4 million must be excluded from the sales comparison. A one-off effect in the previous year resulted from the termination of the contractual relationship with a long-standing distribution partner, while another revenue effect resulted from the crediting of revenue reported in the previous year due to financing problems of the customer. Excluding these non-recurring effects, growth of +16 % for the financial year 2022 was achieved, mainly driven by the increased number of trauma cases treated with LOQTEQ® products, the increased average invoiced price per surgery performed and the development of the USD/EUR exchange rate. Overall, despite the generally unsteady environment, aap succeeded in stabilizing business in the USA and underpinning its dynamic development.

In Latin America (+11 %), the Company achieved significant growth in key markets such as Mexico (+48 %) and Brazil (+30 %), but also established new markets with Ecuador and Venezuela. In the Asia-Pacific region, aap recorded a 40 % year-on-year decline in sales, mainly because of a massive reduction in business volume due to a sharp drop in the price situation with the Chinese distribution partner.
 

EBITDA

in EUR million	FY/2022	FY/2021	Change
EBITDA	-1.7	-0.8	>-100 %
One-time effects	-0.6	-0.4	-50 %
Recurring EBITDA	-2.3	-1.2	-92 %

aap realized a deteriorated EBITDA and Recurring EBITDA (EBITDA excluding one-off effects) of EUR ‑1.7 million (FY/2021: EUR -0.8 million) and EUR -2.3 million (FY/2021: EUR -1.2 million) respectively, in fiscal year 2022. The largest one-off effects resulted from the sharply reduced Corona help programs of EUR 0.6 million, an adjustment in the write-down in inventories of EUR 0.3 million and a derecognition of accrued liabilities of EUR 0.2 million. The following developments in fiscal year 2022 were the main factors:

• Sales level realized in 2022 below the Company’s original planning primarily due to the aforementioned effects from the COVID-19 pandemic, the war in Ukraine, and the general inflationary environment,
• slightly improved gross margin (in %; +2 percentage points) with reduced gross margin in absolute terms due to the decline in sales,
• planned increase in fixed personnel expenses, primarily due to the expansion of the sales infrastructure in Germany and the United States to implement the planned sales growth, and in the areas of quality management, regulatory affairs, and clinical affairs to ensure that certification under the new EU Medical Devices Regulation is achieved by 2024 as planned; offsetting effect in variable personnel expenses, primarily for bonuses and management bonuses due to failure to achieve targets for sales and EBITDA,
• increased cost level (excluding non-recurring effects) in other costs in the operating trauma business incl. central administration functions mainly from unplanned cost increases for energy (here: more than doubling of electricity costs) and purchased inputs, increased costs for insurance and an increased cost level for sales-related costs of distribution (commissions, freight costs) with a simultaneous decrease in costs for legal advice and costs in connection with the termination of legal disputes, costs for external advice and personnel recruitment costs,
• cost increase from conducting the human clinical trial for aap’s innovative silver coating technology with the first surgeries performed,
• increased non-recurring effects that had an earnings-enhancing impact on EBITDA in both comparative periods (mainly from the recognition of income from COVID 19 assistance programs and from the reversal of provisions and accrued liabilities)

Looking at the development of the pure operating trauma business^[2] , we can classify fiscal 2022 as a year of consolidation. Together with the restructuring successes achieved in the years 2019 to 2021, this has also created a basis for the following financial years that will enable profitable growth in the coming years.
 

Cash flow and balance sheet

in EUR million	FY/2022	FY/2021	Change
Cash flow Operating	-1.9	-2.5	+23 %
Cash flow Investment	-0.5	0.2	>-100 %
Cash flow Financing	0.5	3.5	-86 %
	Dec 31, 2022	Dec 31, 2021
Cash and cash equivalents	0.2	2.1	-90 %
Net debt	3.0	3.0	0 %

Based on a net result after tax of EUR -2.6 million, aap‘s operating cash flow improved by +23 % year-on-year to EUR ‑1.9 million in FY/2022, mainly due to better working capital management. Cash flow from investing activities showed an outflow of EUR 0.5 million in the financial year and was accounted for by investments in development projects of EUR 141 thousand (FY/2021: EUR 194 thousand) and property, plant and equipment of EUR 0.3 million (FY/2021: EUR 0.3 million), while the previous year’s figure still included proceeds from disposals of property, plant and equipment of EUR 0.6 million. In the area of financing activities, there was a cash inflow totaling EUR 0.5 million for fiscal year 2022, which was primarily characterized by the proceeds from the capital increase of EUR 1.2 million (FY/2021: EUR 4.8 million), the taking up of a shareholder loan of EUR 0.3 million, the repayment of financial liabilities of EUR 0.7 million (FY/2021: EUR 1.0 million), and the payment of interest of EUR 0.2 million (FY/2021: EUR 0.3 million). As a result, cash and cash equivalents decreased to EUR 0.2 million as of the balance sheet date in FY/2022. Net debt (total of all cash and cash equivalents less all interest-bearing liabilities) was unchanged at EUR 3.0 million as of December 31, 2022.

in EUR million	Dec 31, 2022	Dec 31, 2021	Change
Balance sheet total	20.2	23.0	-12 %
Non-current assets	9.0	9.6	-6 %
Current assets	11.2	13.3	-16 %
Non-current and current liabilities	7.4	10.2	-27 %
Equity	12.8	12.8	0 %
Equity ratio	63 %	56 %	+7 PP

Total assets were EUR 20.2 million at the end of fiscal 2022, around 12 % lower than on December 31, 2021. Non-current assets decreased only marginally by EUR 0.6 million compared with the end of fiscal 2021 because of lower additions from investments in relation to ordinary depreciation and amortization. Current assets decreased to EUR 11.2 million as of the reporting date of the reporting period and were mainly influenced by the decrease in cash and cash equivalents, a lower level of trade receivables and other assets as well as the increase in inventories. Shareholders’ equity remained unchanged at EUR 12.8 million as a result of the offsetting effect of the negative result for the period (FY/2022: EUR -2.6 million) and the conversion rights from the convertible bond exercised in the reporting period with an effect of EUR 1.6 million as well as the capital increase carried out with an effect of EUR 1.2 million as of December 31, 2022. With total assets of EUR 20.2 million as of Dec. 31, 2022 (Dec. 31, 2021: EUR 23.0 million), the equity ratio is 63 % (Dec. 31, 2021: 56 %). Non-current and current liabilities decreased to EUR 7.4 million as of the reporting date of the reporting period and were mainly influenced by the exercise of conversion rights under the convertible bond issued in 2020, the scheduled payments made on lease liabilities and other financial liabilities, and the granting of a further shareholder loan.
 

Outlook
aap aims to set positive accents in terms of sales and earnings in the financial year 2023. The investments in sales started in 2022 form the basis for the planned sales increase in 2023.

The clinical human trial for the innovative antibacterial silver coating technology, which started in 2021, will be continued in the second quarter under a modified study protocol. Under the leadership of the University Hospital Regensburg, Prof. Dr. Alt, the Company plans to include 17 study centers in Germany in the clinical study by late summer. With the new study protocol, we expect a massive acceleration of the study so that the necessary number of patients can be recruited within 12 to 18 months. At the same time, aap is seeking third-party co-funding for the human clinical trial. This can be funded both by additional grants and by development partnerships with companies from application areas outside traumatology.

In addition, a major focus will be on implementing activities as planned to achieve certification under the new EU Medical Device Regulation (MDR 2017/745/EU) within the transition period until 2024. The availability of the Notified Body will also be a factor in achieving this goal.

Not included in the following forecast statements:

• A significant tightening of sanctions against Russia or a change in the interpretation of existing sanctions,
• an expansion of the conflict situation outside Ukraine,
• an additional significant increase in energy and raw material prices, among other things due to the war in Ukraine or the associated sanctions, or
• further virus mutations (COVID 19 pandemic) leading to a renewed widespread infection situation with corresponding lockdown measures or other restrictions in the sales regions relevant for aap or production stoppages at the Berlin site or at aap‘s service providers/suppliers.

The Executive Board forecasts sales of between EUR 12.0 million and EUR 14.0 million for fiscal year 2023. The management assumes a similar distribution of sales over the individual quarters as in the previous year, with a possible acceleration in the fourth quarter. Regarding earnings, the Management Board expects EBITDA to be between EUR -2.5 million and EUR -1.7 million in fiscal year 2023, based on the planned sales growth and further efficiency improvements to be realized, but with higher costs for the implementation of the clinical trial for the silver coating technology compared to the previous year. In this context, the management aims to achieve an improved operating cash flow for the company as a whole, excluding the costs for the silver coating technology and, in particular, the human clinical trial, if the development is in line with the budget in the current fiscal year. After deducting the remaining financing expenses and the costs for the clinical human study, however, aap will still report a negative cash flow.

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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 headquartered in Berlin, Germany. The company develops, manufactures and markets products for traumatology. In addition to the innovative anatomical plate system LOQTEQ®, 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 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 Executive 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.

 

 

^[1]CER = Constant Exchange Rates.

^[2] aap Group excluding development costs for silver coating and resorbable magnesium implant technologies, non-recurring one-off effects and non-allocable central costs

Contact:
aap Implantate AG; Marek Hahn; Member of the Management Board, CFO; Lorenzweg 5; 12099 Berlin
Phone: +49 (0)30 75019 – 134; Fax: +49 (0)30 75019 – 290; E-Mail: m.hahn@aap.de