EQS-News: Q3/2022: Again significant growth in the US (+45 %) with sales of EUR 1.0 million; total sales and EBITDA impacted by continued volatile market environment

aap Implantate AG ("aap" or the "Company") was able to realize slight sales growth in the third quarter contrary to the general downward trend in the trauma sector and in a persistently volatile market environment. Thereby, the Company's sales in Q3/2022 increased by 1 % to EUR 3.0 million compared to the same period of the previous year (Q3/2021: EUR 3.0 million). In the first nine months of the current fiscal year, sales decreased by 4 % to EUR 8.5 million compared to 9M/2021 (9M/2021: EUR 8.9 million). Taking into account constant exchange rates, the changes in sales were 3 % (Q3) and 8 % (9M).

With regard to earnings, the Company recorded normalized EBITDA¹ of EUR 0.4 million (reported: EUR 0.8 million; Q3/2021: +EUR 20 thousand) in the third quarter and of EUR 1.5 million (9M/2021: EUR +0.1 million) in the first nine months of 2022, respectively, mainly reflecting the decline in sales (9M), the expansion of the sales infrastructure in Germany and the U.S. as planned, the execution of the clinical trial for aap's innovative antibacterial silver coating technology as well as the extensive work on processes and documents to meet the increased regulatory requirements of the new EU Medical Device Regulation (MDR). In addition, other operating income decreased, and the Company faced partly massive unplanned cost increases (e.g. procurement prices for energy and purchased inputs) from the observable increasing pressure on global supply chains and the general inflationary cost environment, e.g. as a result of the war in Ukraine.

In general, regarding the regions outside North America, the Company continues to face the existing and now also worsening pandemic COVID-19 situation, related increasing staff shortages in hospitals and also in the increasing but persistently too low mobility and the changed mobility behavior of the populations, which is reflected in lower case numbers compared to pre-COVID-19 levels. In addition, the still ongoing war in Ukraine, the observable dynamic pressure on global supply chains and the general inflationary (cost)environment are generally affecting business development.

Q3/2022 and 9M/2022 - Key financial figures

Sales Q3/2022 and 9M/2022

Looking at the individual regions, the picture in North America is very positive: the Company achieved significant sales growth of +45 % and +9 % in both the third quarter and the first nine months. This shows a clear recovery of the market in the third quarter compared to the first half of 2022. Above all, the increased average invoiced price per surgery performed was the main factor behind the increase in sales; in addition, the development of the USD/EUR exchange rate was also beneficial. Even taking into account constant exchange rates, the changes in sales were a remarkable +24 % in the third quarter or almost at the level of the previous year in a nine-month comparison.

For the sales regions outside North America, the aforementioned effects ran through almost all markets relevant to aap, albeit to varying degrees. In the EMEA region, the Company recorded a 7 % decline in sales in the third quarter, which resulted in a sales decrease of also 7 % in the first nine months of the financial year. This was mainly due to developments in markets outside the EU, which showed a lower volume of business than in the previous year. The markets within the EU showed a slightly positive development in the third quarter, although the home market of Germany was down on the previous year due to lower case numbers in clinics using aap products. By contrast, the market in South Africa, among others, developed positively in the nine-month period with significant double-digit growth, although this could only partially compensate for the development of the other submarkets in the EMEA region. Following encouraging developments in the first half of the year, the LATAM region realized a 22 % decline in sales in the third quarter, resulting in a reduction of 8 % in the nine-month period. The encouraging growth in Mexico in Q3 of 84 % could not fully compensate for the declines in the Puerto Rico and Chile markets. In addition, sales in the prior-year quarter were significantly impacted by an initial equipment order from a new customer in Colombia. In the APAC region, aap recorded a sales decline of 27 % in the third quarter and 42 % in the nine-month period compared with the respective comparative period of the previous year, mainly because of a reduced volume of business due to a sharp drop in the price situation with the Chinese distribution partner.

EBITDA Q3/2022 and 9M/2022

Regarding earnings, comparable EBITDA (normalized¹) decreased year-on-year to EUR 0.4 million for Q3 2022 (reported: EUR 0.8 million; Q3/2021: EUR +20 thousand) and to EUR -1.5 million for the first nine months of 2022 (9M/2021: EUR +0.1 million). The following developments were particularly decisive in this regard:

• Revenue level realized in the first nine months below the Company's original planning mainly due to the aforementioned effects from the COVID-19 pandemic, the war in Ukraine and the general inflationary environment; Q3/2022 revenue level in line with the revised expectation range,
• Reduced gross margin in absolute terms due to decline in sales (9M) with stable high gross margin (in %); gross margin normalized¹ in Q3/2022 at around prior-year level,
• Planned increase in personnel expenses mainly due to the expansion of the sales infrastructure in Germany and the USA to drive the planned sales growth, as well as in the areas of quality management, regulatory and clinical affairs to ensure, as planned, the achievement of certification in accordance with the new EU Medical Device Regulation (MDR 2017/745/EU) within the transition period until 2024,
• 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) because of the sales expansion in North America,
• Cost increase from the conduct of the human clinical trial of aap's innovative silver coating technology with the first surgeries performed and the inclusion of further hospitals participating in the trial in the first nine months of 2022,
• Lower non-recurring effects that had an earnings-enhancing impact on EBITDA in both comparative periods (mainly from the recognition of income from COVID 19 support programs and from the reversal of provisions and accrued liabilities).

Excluding non-recurring items, comparable Recurring EBITDA (normalized¹) decreased to EUR 0.3 million (reported: EUR 0.8 million; Q3/2021: EUR +4 thousand) and to EUR 1.7 million (9M/2021: EUR 0.4 million) in the third quarter and first nine months of 2022, respectively.

Financing

With a view to stabilizing aap's financial position, the Company successfully executed a capital increase of around 10 % in September/October. A total of around 0.6 million new shares were issued excluding subscription rights by way of a private placement against cash contributions at a subscription price of EUR 1.99, so that the Company received a net inflow of around EUR 1.2 million after deduction of consultancy fees and other costs. The new shares were subscribed by a strategic investor from Asia, who already has business activities in the field of orthopedics. As of September 30, 2022, the Company reported cash and cash equivalents of approximately EUR 1.0 million.

Silver coating technology

Regarding aap's innovative antibacterial silver coating technology, an application for an amendment to the clinical trial plan was submitted following restrained patient recruitment in the first nine months of 2022. This was approved by the relevant authorities and is currently being implemented. Thus, aap expects that the necessary number of patients will be reached at the beginning of 2024 and that the mandatory follow-up year will then begin. In addition, aap is still in talks about possible co-financing of the human clinical trial and further cooperation opportunities.

Outlook

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,
• Further additional significant increases in energy and raw material prices above the currently foreseeable level or restrictions on the Company's ability to operate because of partial or complete cessation of gas and/or energy supplies due, among other things, to the war in Ukraine or related sanctions,
• Further virus mutations (COVID 19 pandemic) leading to a significant worsening of the infection situation with corresponding lockdown measures or other restrictions in the sales regions relevant for aap or resulting in production stoppages at the Berlin site or at aap's service providers/suppliers.

Based on Q3 2022 results, a continued volatile market environment due to the war in Ukraine and a re-aggravating pandemic COVID-19 situation, and including consideration of ongoing inflationary pressures, the Company now expects revenue and EBITDA at the lower end of the guidance range of EUR 11.5 million to EUR 13.5 million (revenue) and EUR -2.0 million to EUR -1.1 million (EBITDA), respectively.

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aap Implantate AG (ISIN DE0005066609) - General Standard/Regulated Market - All German Stock Exchanges -
 

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