Company Announcement no. 18/2014
To: NASDAQ OMX Copenhagen A/S Hørsholm, Denmark, 20 August, 2014
Veloxis Pharmaceuticals announces financial results for the first six months of 2014
Highlights:
- On 28 July the European Commission granted marketing authorization for Envarsus® for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU).
- Following the European marketing authorization Veloxis will receive a milestone payment of USD 15 million from our European partner Chiesi in the third quarter 2014 which is in line with expectations. The payment will be recognized fully as income in the third quarter 2014.
- Envarsus® XR for the prevention of organ rejection in kidney transplant patients is under regulatory review by the U.S. FDA and has a PDUFA action date of October 30, 2014.
- The once-daily Envarsus® XR (tacrolimus extended-release tablets), an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, has demonstrated a lower treatment failure rate in African-Americans compared with twice-daily tacrolimus (Prograf®).
- The two-year results of the pivotal Phase 3 clinical trial, Study 3002, of Envarsus® XR in de novo kidney transplant patients continued to demonstrate non-inferiority compared to tacrolimus capsules (Prograf®; Astellas Pharma).
- Veloxis reported a net loss of DKK 53.1 million for the first half of 2014 compared to a net loss of DKK 80.5 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 half of 2014, Veloxis’ research and development costs amounted to DKK 51.0 million compared to DKK 81.7 million during the same period in 2013.
- On 30 June, 2014, Veloxis had cash and cash equivalents of DKK 264.2 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 30 June 2014, the Company’s cash position equaled DKK 264.2 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, 21 August, 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 89298792
Following the conference call, a recording will be available on the company’s website http://www.veloxis.com.
