Company Announcement no. 24/2014
To: NASDAQ OMX Copenhagen A/S Hørsholm, Denmark, 12 November, 2014
Veloxis Pharmaceuticals announces financial results for the first nine months of 2014 and improves the full year outlook
Highlights:
- On 31 October the U.S. Food and Drug Administration has informed Veloxis of the tentative approval of Envarsus® XR. FDA stated that the final approval of Envarsus XR will be delayed until expiration of the exclusivity period for Astellas’ Astagraf XL®. Veloxis understands that this expiry is anticipated to occur July 19, 2016. Veloxis is appealing the FDA decision.
- The European Commission has in July 2014 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 has received a milestone payment of USD 15 million from our European partner Chiesi in the third quarter 2014. The payment is recognized fully as income in the third quarter 2014.
- Veloxis reported a net profit of DKK 12.9 million for the first nine months of 2014 compared to a net loss of DKK 114.6 million for the same period in 2013. The reported net result is in line with expectations and the financial outlook for 2014 is maintained.
- For the first nine months of 2014, Veloxis’ research and development costs amounted to DKK 70.4 million compared to DKK 117.0 million during the same period in 2013.
- On 30 September, 2014, Veloxis had cash and cash equivalents of DKK 310.6 million.
- The full year outlook for 2014 is improved. Veloxis now expects an operating loss in the range of DKK 40 - 70 million, and a net loss in the range of DKK 20 - 50 million. Veloxis’ cash position is expected to be in the range of DKK 255 - 285 million at year-end 2014.
Outlook for 2014
The full year outlook for 2014 is improved. Veloxis now expects an operating loss in the range of DKK 40 - 70 million, and a net loss in the range of DKK 20 - 50 million
The improvement is driven by lower clinical study costs and delayed cost in the US sales and marketing infrastructure.
Cash and cash equivalents are expected to be in the range of DKK 255 - 285 million at 31 December 2014. This compares with expectations of DKK 230 – 270 million announced in connection with the annual report for 2013.
Conference call
A conference call will be held tomorrow, 13 November, 2014 at 3:00 PM CET (Denmark); 2:00 PM GMT (London), 9:00 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 28069222
Following the conference call, a recording will be available on the company’s website http://www.veloxis.com.
