+ EU authorisation: very good results on track towards co.don AG’s main strategic objective
+ Successful realignment following management handover
+ Funding secured for the company’s future organisational structure
+ Sales record in Q4 2015 + Further revenue and earnings growth in the current financial year
Teltow, 01.03.2016 – co.don AG has reported its most successful year in the company’s history to date: In financial year 2015 revenue increased by some 14% (all 2015 figures unaudited). 2015 earnings before interest, tax, depreciation and amortisation (EBITDA), as a measure of operating performance – without the strategic costs of marketing authorisation – improved hugely on financial year 2014 (EUR -557k) to reach break-even. This result is reduced by unplanned, non-recurring expenses for the management handover and initial costs for the reorganisation of the company.
Comprehensive income 2015 (net loss for the year) is still negative due to the strategic investments to obtain EU marketing authorisation. More than EUR 12 million have been invested since 2009 to obtain EU marketing authorisation for the articular cartilage product. Detailed figures for the financial year 2015, including capital expenditure, will be announced when the annual report is published in late April 2016.
+ EU authorisation: Both clinical trials in post-operative observation period, positive interim results of clinical Phase II study EU marketing authorisation for the pharmaceutical product co.don condrosphere® remains the most important strategic objective for the company. To this end co.don AG is currently carrying out two clinical trials, which are now both in the follow-up observation period. The aim of the phase III clinical study is to compare the effectiveness and safety of matrix-associated autologous chondrocyte implants (ACI-M) using co.don condrosphere® with the alternative microfracture treatment. In another long-term phase II clinical trial, patients with cartilage defects of 4-10 cm2 in the knee joint were treated with co.don condrosphere®, an autologous chondrocyte implant. Analysis of the post-operative data confirms the positive effectiveness and safety of the pharmaceutical product at all the doses tested and provides evidence of a significant improvement in patient well-being. In the third year of data collection it shows an improvement in the effectiveness data gathered by both patients and physicians. The results are confirmed by diagnostic imaging methods.
+ New management drives international orientation of the company Dirk Hessel became Chief Executive Officer of the company on 14 July 2015. In Mr Hessel the company has gained an entrepreneur with great management experience and proven international sales expertise in the pharmaceutical sector, who together with his colleague on the Executive Board, Vilma Methner, will drive the company’s course of successful international expansion. Preparations for entering the market have begun in the expectation of obtaining EU marketing authorisation in late 2017.
+ Funding secured for EU roll-out preparations
The very successful capital increase carried out in autumn 2015 enabled the company to raise some EUR 4.9m in cash. The capital increase was heavily oversubscribed by 38%, reflecting strong market acceptance of the co.don investment case. Issue proceeds will mainly be used to prepare for the EU-wide product launch of the pharmaceutical product co.don condrosphere® and to expand market penetration in Germany.
“The strong interest in the capital increase from both existing and new investors is an important acknowledgement of our operational progress and shows great support for our accelerated sales and EU roll-out strategy. This funding now enables us to drive forward the preparations for the European product launch and to scale up the sales offensive in Germany”, said Dirk Hesse, CEO of co.don AG.
+ Sales record in Q4 2015, further revenue and earnings growth in the current financial year
Under the leadership of the new CEO the company has sharpened its commercial profile: with the operating activities initiated to date and its preparations for a European product launch the company is positioning itself to become the clear market leader in the Germany market. The steps taken to expand distribution capacities resulted in an above-average inflow of new monthly orders in the fourth quarter last year and this trend has continued into the new financial year. In January 2016 the company again reported a very positive performance, with growth of 30% compared with the same period last year.
Management’s other planned activities going forward concentrate on the German domestic market, realising the company’s international ambitions and its strategic focus on Europe.
So production capacities are being expanded in preparation for European market entry and other steps taken to prepare for the EU roll-out. The continued internationalisation of co.don AG’s market presence will increasingly be driven by visits and active involvement in trade fairs and congresses. About co.don® AG: Berlin-based co.don AG develops, produces and markets in Germany autologous cell therapies for the minimally invasive repair of cartilage damage to joints following traumatic or degenerative defects. co.don condrosphere® is a cell therapy product that uses only the patient’s own cartilage cells (“autologous chondrocytes”). co.don condrosphere® has been approved by the German federal agency PEI in accordance with Section 4b of the German Pharmaceuticals Act (AMG) and is currently undergoing Phase II and III clinical trials to obtain European marketing authorisation. co.don condrosphere® has been used for more than 10 years in over 120 clinics to treat more than 8,500 patients. In Germany the statutory health insurance companies have paid for the treatment of knee and hip joints since 2007 and for the treatment of vertebral joints since 2008. The shares in co.don AG are listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227).
