Company Announcement no. 11/2014
To: NASDAQ OMX Copenhagen A/S Hørsholm, Denmark, 14 May, 2014
Veloxis Pharmaceuticals announces financial results for the first three months of 2014
Highlights:
- The U.S. Food and Drug Administration (FDA) has accepted for standard review the company's New Drug Application (NDA) for Envarsus® for the prevention of organ rejection in adult kidney transplant patients. The FDA has set a target review date under the Prescription Drug User Fee Act (PDUFA) of October 30, 2014.
- The Company has previously reported that the MAA for Envarsus® had been accepted by the European Medicines Agency (EMA). A CHMP opinion is expected in 2Q 2014 and regulatory action on the application is expected in 3Q 2014.
- Veloxis reported a net loss of DKK 20.0 million for the first quarter of 2014 compared to a net loss of DKK 35.7 million for the same period in 2013. The reported net loss is in line with expectations and the financial outlook for 2014 is maintained.
- For the first quarter of 2014, Veloxis’ research and development costs amounted to DKK 26.6 million compared to DKK 38.9 million during the same period in 2013.
- On 31 March, 2014, Veloxis had cash and cash equivalents of DKK 296.2 million.
Outlook for 2014
Veloxis maintains its 2014 outlook with an operating loss of DKK 60-90 million and a net loss of DKK 55-85 million for the financial year 2014.
As at 31 March 2014, the Company’s cash position equaled DKK 296.2 million, and as at 31 December 2014, the Company’s cash position is expected to be in the range of DKK 230-270 million.
Conference call
A conference call will be held tomorrow, 15 May, 2014 at 2:00 PM CET (Denmark); 1:00 PM GMT (London), 8:00 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 35440957
Following the conference call, a recording will be available on the company’s website http://www.veloxis.com.
