Company Announcement no. 20/2013
To: NASDAQ OMX Copenhagen A/S Hørsholm, Denmark, 13 November, 2013
Veloxis Pharmaceuticals announces financial results for the first nine months of 2013 and improves the full year Outlook
Envarsus® program progresses according to plan
Highlights:
- Veloxis’ Marketing Authorization Application (MAA) to market Envarsus® (formerly LCP-Tacro™) for the prevention of organ rejection in kidney transplant patients in the European Union remains under review with the European Medicines Agency (EMA). The company expects the decision from the European Union in 2014.
- Preparations continue for the submission of a New Drug Application (NDA) for Envarsus® to the US Food and Drug Agency (FDA) in late 2013.
- Veloxis reported a net loss of DKK 114.6 million for the first nine months of 2013 compared to a net loss of DKK 216.2 million for the same period in 2012.
- For the first nine months of 2013, Veloxis’ research and development costs amounted to DKK 117.0 million compared to DKK 168.8 million during the same period in 2012.
- On 30 September, 2013, Veloxis had cash and cash equivalents of DKK 380.2 million.
- The full year outlook for 2013 is improved. Veloxis now expects an operating and net loss in the range of DKK 160-190 million. Veloxis’ cash position is expected to be in the range of DKK 310-340 million at year-end 2013.
Outlook for 2013
The full year outlook for 2013 is improved. Veloxis now expects an operating and net loss in the range of DKK 160-190 million.
Veloxis’ earlier outlook for 2013, which was announced in connection with the annual report for 2012 in March 2013, projected an operating and net loss of DKK 170-200 million.
The improvement is a result of continuous cost optimization. Further, cash position will be positively impacted by timing of accounting costs not yet paid at year-end.
Cash and cash equivalents are expected to be in the range of DKK 310-340 million at 31 December 2013. This compares with expectations of DKK 270–310 million announced in connection with the annual report for 2012.
Conference call
A conference call will be held tomorrow, 14 November, 2013 at 4:00 PM CET (Denmark) ; 3:00 PM GMT (London), 10:00 AM EST (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 96780245
Following the conference call, a recording will be available on the company’s website http:// www.veloxis.com .
