12.03.2015 | press release, Aktuell

co.don AG: Key milestones reached and operating result substantially improved in 2014

+ EU authorisation: required number of patients registered for phase III clinical trials for co.don condrosphere® product
+ Funding for EU authorisation process secured
+ January 2015 – highest revenue since company foundation

Teltow, 12.3.2015 – co.don AG can look back on its most successful year to date. All the ambitious goals the company set itself to achieve a sustainable increase in enterprise value were reached in the year 2014.

EU marketing authorisation for its patented pharmaceutical product remains the most important strategic objective for the company.

Last year revenue increased by some 23% (unaudited). The operating loss was reduced by more than half. Earnings before interest, taxes, depreciation and amortisation (EBITDA) from operating activities came to EUR -557k (unaudited); previous year: EUR -1,343k. EBITDA for 2014 includes expenses for virtual shares of approximately EUR 300k (previous year: EUR 250k). Comprehensive income is still depressed by the very substantial strategic investments to obtain EU marketing authorisation. More than EUR 10 million have been invested since 2009 to obtain EU marketing authorisation for the articular cartilage product, including EUR 1.9 million in 2014 alone. Detailed figures for the financial year 2014 will be announced when the annual report is published in late April 2015.

+ EU approval: required number of patients for phase III clinical trials registered at year-end

co.don AG is carrying out two clinical trials in connection with EU marketing authorisation for the co.don condrosphere® product. Last year a number of key milestones were reached: The aim of the phase III clinical study is to compare the effectiveness and safety of matrix-associated autologous chondrocyte implants (ACI-M) with co.don condrosphere® against microfracture treatment and to present these data to the European Medicines Agency in London. The necessary number of patients have been recruited for this clinical trial.

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 matrix-associated chondrocyte implant. Analysis of the one-year data confirms the positive effectiveness and safety profile of the pharmaceutical product at various dosages. The first clinical data from the phase II trials will be published at the 12th World Congress of the International Cartilage Repair Society (ICRS) in May 2015 in Chicago.

+ Funding for EU authorisation process secured

With its highly successful rights issue in spring 2014 the company raised fresh capital of €4.95 million. The capital increase was oversubscribed by 72%. Issue proceeds will mainly be used to continue the trials required to obtain central EU marketing authorisation for the cell-based pharmaceutical product co.don condrosphere®.

"The significant oversubscription shows the growing interest in our company and also demonstrates the greater confidence in the future performance of co.don AG among new investors", said Dr Andreas Baltrusch, CEO of co.don AG.

co.don AG's business segment has considerable potential: Experts estimate the potential market for minimally invasive, regenerative joint treatment at a minimum of €250 million p.a. in Germany alone, and in the EU at up to €1 billion p.a.

+ January 2015 – highest revenue since company was established

The company's strong performance continued into the new year: January 2015 saw the highest revenue since company foundation.

Demand is growing for the procedures developed and patented by co.don AG for removing, cultivating and re-implanting autologous cartilage cells. The company is now deriving the benefits of having established itself as the technology leader in Germany for cartilage regeneration in recent years.

But at the same time it is now turning its sights to markets outside Europe: the company is boosting its international presence by exhibiting at trade fairs, including ARAB HEALTH (UAE) and others in the USA.

+ Priority tasks in the current financial year

EU marketing authorisation remains the most important strategic objective for the company. International publications are currently being prepared on the results of the phase II clinical trials.

In addition to cutting operating costs in all areas of the company, production capacities are being expanded in expectation of EU marketing authorisation and other steps taken to prepare for the EU roll-out.

At the same time co.don AG is looking to sign licensing agreements.

About co.don® AG: The biopharmaceutical company based near Berlin is one of the leading specialists worldwide in cell cultivation for the regenerative treatment of articular cartilage defects and spinal disc defects. The company's patented pharmaceutical products are used to treat cartilage damage. Left untreated, cartilage defects can often result in joint replacement surgery.

Orthopaedic, accident and neuro-surgeons are increasingly applying these regenerative therapy methods. co.don® AG is listed on the Frankfurt Stock Exchange (ISIN: DE000A1K0227). The company's Executive Board is made up of Dr Andreas Baltrusch (CEO) and Ms Vilma Methner (COO, CSO).

More information is available at www.ihre-zellzuechter.de or www.codon.de

Press contact

Matthias Meißner, M.A.

Corporate communications / IR / PR

+49 +49 3328 43460

Fax: +49 03328 434643


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