aap: Solid Q3/2019 with sales and EBITDA in line with expectations; sales growth and improved Recurring EBITDA in 9M/2019

DGAP-News: aap Implantate AG / Key word(s): 9 Month figures
14.11.2019 / 13:19
The issuer is solely responsible for the content of this announcement.

Q3/2019 and 9M/2019 - Major results and progress

- Sales by region: In traditionally weaker Q3 solid sales growth in Germany and slight temporary decline in USA and international business; USA with positive development since end of September 2019 with almost doubling of weekly number of cases year-on-year and increasing interest from national group purchasing organizations with negotiations on first contracts; 9M: continuation of growth trend driven by Germany and international business, further stabilization in USA
 

- Earnings: EBITDA in 9M subject to significant one-time effects (EUR 1.3 million), primarily from early termination of contract with former CEO, termination of legal disputes and correction of legacies from inventory of US stocks from previous years; in 9M recurring EBITDA, adjusted for one-time effects, improved to EUR -3.6 million (+7%); EBITDA in Q3 burdened by one-time effects (EUR 0.3 million) and temporary decline in gross margin
 

- Gross margin: Increased cost of materials for pre-production of systems for human clinical study for silver coating technology and of sterile products as well as correction of legacies from inventory of US stocks from previous years with total volume of EUR 0.3 million lead to temporary decline in gross margin^[1] in Q3/2019; gross margin from operating activities (adjusted for above effects) increases to 79% in 9M (9M/2018: 78%)
 

- Costs: Declining cost level (normalized for one-time effects) for personnel and other expenses both in Q3 (+EUR 0.4 million) and in 9M (+EUR 0.3 million)
 

- Cash flow and balance sheet: Cash need in 9M/2019 totalled EUR 5.8 million; cash holdings amounted to EUR 4.4 million^[2]; first-time application of IFRS 16 - Leasing and concluded factoring agreement lead to shifts in balance sheet, income statement and cash flow
 

- LOQTEQ(R): FDA approval for polyaxial LOQTEQ(R) VA foot and calcaneus systems - Launch in USA and further markets planned for beginning of 2020; continuous focus on adaption of processes and documents to new regulatory requirements of MDR and development of sterile packaging for implants
 

- Silver coating technology: BfArM approval received for human clinical study; further funding of human clinical study applied for at BMBF, funding decision expected shortly; training of doctors participating in study and preparation of equipment of corresponding clinics with silver-coated implants; for start of study in Germany approval of ethics committees still required, documents submitted, approval expected
 

- Resorbable magnesium implant technology: Talks with technology-savvy investors to jointly further develop technology; progress on approval pathway agreement with FDA; pilot animal study with University of Colorado started end of September 2019 to generate key preclinical data
 

Q3/2019 and 9M/2019 - Financials

Q3 Sales

9M Sales

Q3 EBITDA

*Includes cost of external staff and correction of legacies from inventory of US stocks from previous years.
**Includes cost of evaluation of strategic options, external staff and project Quality First / Fit-4-MDR.

 

9M EBITDA

* Includes cost of personnel measures, termination of legal disputes (net effect), external staff and correction of legacies from inventory of US stocks from previous years.
**Includes cost of evaluation of strategic options, external staff and project Quality First / Fit-4-MDR.


 

In the traditionally weaker third quarter, aap recorded solid sales growth (+4%) in Germany, while a slight temporary decline was recorded in the USA (-3%) and in international business (-1%). In the USA, this was due to the termination of a sales relationship with an US distributor, while in international business a quarterly fluctuation was recorded in the BRICS states. In the USA, aap has seen a positive development since the end of September 2019. The number of weekly operations almost doubled compared to the same period of the previous year. In addition, aap is registering an increasing interest from national group purchasing organizations with negotiations on first contracts, which is reflected in the current negotiations on the first contracts. These developments should also be reflected in the corresponding sales momentum in the coming months. On a nine-month basis, the existing growth trend (+6%) was mainly driven by Germany (+5%) and international business (+7%), while the sales development in the USA (+1%) was further stabilized.

 

Outlook
For the 2019 financial year, the Management Board continues to expect sales of between
EUR 11.0 million and EUR 13.0 million and EBITDA of between EUR -6.0 million and EUR -5.0 million. This corresponds to an increase in sales of +2% to +21% and an improvement in EBITDA of +6% to +22% compared with the respective prior-year figures.

 

The Management Board will further consistently continue its analysis to identify cost reduction and efficiency enhancement potentials. In this context, measures have already been implemented, such as the change of the stock exchange listing and the discontinuation of parts of the standard trauma portfolio. In addition, aap will in future focus even more on sales expansion with higher-margin customers and products, as well as on further driving forward the marketing of its innovative and promising technologies. With a view to its antibacterial silver coating technology, aap will further intensify talks and negotiations with interested global medical technology companies following the approval of the human clinical study by the Federal Institute for Drugs and Medical Devices ("BfArM"). For its innovative resorbable magnesium implant technology aap aims to push forward the further development of this promising technology jointly with partners under aap's management. In this context the Company is currently in talks with technology-savvy investors. All of these measures shall form the basis for sustainable and profitable growth.

 

^[1] Relating to sales revenues, changes in inventories of finished and unfinished products and cost of materials / purchased services.

^[2] In the consolidated balance sheet of 30/09/2019 EUR 3.7 million is stated as cash and cash equivalents, while cash with banks totalling EUR 0.7 million is shown under current and non-current other financial assets as it was pledged to secure financial liabilities respectively cash payments were made to secure bank guarantees granted to third parties.

^[3] In the previous year, sales with Puerto Rico were reported as part of North America (distributors); from Q3/2019 as part of RoW (= Rest of World).

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

About aap Implantate AG
aap Implantate AG is a globally operating medical device company headquartered in Berlin, Germany. The company develops, manufactures and markets trauma products for orthopaedics. The IP protected portfolio includes besides the innovative anatomical plating system LOQTEQ(R) and trauma complementary biomaterials a wide range of cannulated screws as well as standard plates and screws. Furthermore, aap Implantate AG has an innovation pipeline with promising development projects as the antibacterial silver coating technology and magnesium based implants. These technologies address critical problems in surgery that haven't yet been resolved adequately. In German-speaking Europe aap Implantate AG directly sells its products to hospitals, buying syndicates and hospital groups while it uses a broad network of distributors in more than 25 countries at the international level. aap Implantate AG's stock is listed in the General Standard segment of Frankfurt Stock Exchange (XETRA: AAQ.DE). For more information, please visit 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.


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