Company Announcement no. 13/2015
To: NASDAQ OMX Copenhagen A/S Hørsholm, Denmark, 20 May, 2015
Veloxis Pharmaceuticals announces financial results for the first three months of 2015
Highlights:
- Veloxis has announced that once-daily Envarsus® XR, an investigational new drug under FDA review for the prevention of organ rejection in adult kidney transplant patients, demonstrated that a lower dose of once-daily Envarsus® XR in African-American kidney transplant patients is sufficient to achieve therapeutic tacrolimus blood concentrations, compared to twice-daily immediate release tacrolimus.
- The U.S. District Court for the District of Columbia has set a briefing schedule that enabled complete briefing in its pending case by 3 March, 2015. Veloxis is seeking an order requiring FDA to grant final approval to Envarsus® XR. While Veloxis currently expects the matter to be resolved by mid-year 2015, it is possible that delays may occur. There can be no assurance that Veloxis will be successful in its action against FDA.
- Veloxis is preparing for launch of Envarsus® XR in the US in the second half of 2015, either for the full indication that would include both de novo and conversion kidney transplant patients or for a more narrow initial indication in the conversion setting.
- Veloxis reported a net loss of DKK 27.0 million for the first quarter of 2015 compared to a net loss of DKK 20.0 million for the same period in 2014. The reported net loss is in line with expectations and the financial outlook for 2015 is maintained.
- For the first quarter of 2015, Veloxis’ sales and marketing costs amounted to DKK 9.8 million. Research and development costs amounted to DKK 20.8 million compared to DKK 26.6 million during the same period in 2014.
- On 31 March, 2015, Veloxis had cash and cash equivalents of DKK 233.6 million.
Outlook for 2015
Veloxis maintains its 2015 outlook with an operating loss of DKK 200 - 240 million and a net loss of DKK 195 - 235 million for the financial year 2015.
On 31 March 2015, the Company’s cash position equaled DKK 233.6 million, and on 31 December 2015, the Company’s cash position is expected to be in the range of DKK 55 - 95 million.
Conference call
A conference call will be held tomorrow, 21 May, 2015 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 71 16 60 (Denmark)
+44 (0) 20 3427 1913 (UK)
+1 212 444 0896 (USA)
Access code 7709988
Following the conference call, a recording will be available on the company’s website http://www.veloxis.com.
