Company Announcement no. 16/2013
To: NASDAQ OMX Copenhagen A/S Hørsholm, Denmark, 21 August, 2013
Veloxis Pharmaceuticals announces financial results for the first half 2013
Highlights:
- LCP-Tacro™ has successfully demonstrated non-inferiority compared to tacrolimus (Prograf®; Astellas Pharma) in its Phase III clinical trial, Study 3002. The Phase III randomized, double-blind and double-dummy study in 543 de novo kidney transplant recipients, with Prograf® as the comparator, met its primary efficacy and primary safety endpoints. The study was conducted under a Special Protocol Agreement with the FDA and the results are considered pivotal for the planned U.S. regulatory filing expected to occur in the second half of 2013.
- The European Medicines Agency (EMA) has accepted for review the company’s Marketing Authorization Application (MAA) to market LCP-Tacro™ for the prevention of organ rejection in kidney transplant patients in the European Union. Veloxis expects the decision from the European Union in 2014.
- Final STRATO clinical study data have demonstrated the potential for LCP-Tacro™ to improve tacrolimus-induced tremors in stable kidney transplant patients.
- Veloxis reported a net loss of DKK 80.5 million for the first half of 2013 compared to a net loss of DKK 160.6 million for the same period in 2012. The reported net loss is in line with expectations and the financial outlook for 2013 is maintained.
- For the first half of 2013, Veloxis’ research and development costs amounted to DKK 81.7 million compared to DKK 119.5 million during the same period in 2012.
- On 30 June, 2013, Veloxis had cash and cash equivalents of DKK 399.7 million.
Outlook for 2013
Veloxis maintains its 2013 outlook with an operating and net loss of DKK 170-200 million for the financial year 2013.
As at 30 June 2013, the Company’s cash position equaled DKK 399.7 million, and as at 31 December 2013, the Company’s cash position is expected to be in the range of DKK 270-310 million.
Conference call
A conference call will be held tomorrow, 22 August, 2013 at 3:00 PM CET (Denmark) ; 2:00 PM GMT (London), 9:00 AM EDT (New York).
To access the live conference call, please dial one of the following numbers:
+45 32 72 80 18 (Denmark)
+44 (0) 1452 555 131 (UK)
+1 866 682 8490 (USA)
Access code 30348398
Following the conference call, a recording will be available on the company’s website http:// www.veloxis.com .
