HOERSHOLM, Denmark, Aug. 24, 2016 (GLOBE NEWSWIRE) -- Highlights
- FDA approves label enhancement for Envarsus XR(r) which establishes dosing and PK profile in African-Americans and rapid metabolizers of tacrolimus
- Favorable signal in cardiovascular outcomes in African-Americans from ASERTAA trial, and two-year safety results from STRATO trial presented at American Transplant Congress
- 34% of US transplant centers have prescribed Envarsus(r)
In connection with the financial report, Veloxis President and CEO, Craig A. Collard, said:
"In the first half of 2016, we have focused on the US launch of Envarsus through the establishment of a new commercial management team and have transitioned Danish activities to the US. Envarsus is on a clear growth trajectory in the US and EU markets."
Net revenue for the first half of 2016 totaled 3,267 tUSD compared with 1,431 tUSD in first half of 2015, reflecting the US market launch in December 2015 and successful adoption of Envarsus XR in the US. Chiesi, under its license for European commercialization, continues to grow European sales and to launch Envarsus XR in additional European countries. Veloxis reported a net loss of 16,407 tUSD for the first half of 2016 compared to a net loss of 9,879 tUSD for the same period in 2015. The reported net loss is higher than for the same period in 2015 due to the launch and commercialization costs incurred in the US and is in line with expectations. Our financial outlook for 2016 is maintained as below.
Outlook for 2016
Veloxis has revised its 2016 outlook to an operating loss and net loss of USD 25.0 - 31.0 Million compared to the previously reported USD 17.6 - 23.4 Million.
The revision to the outlook is the result of increased costs due to the continued restructuring of the company from a development organization with headquarters in Denmark to a commercial organization with all major activities in the US. Further the outlook is impacted by additional costs related to warrant schemes for Management and new employees. The costs related to warrants is a non cash item and does not result in any cash consideration being paid by the company nor does it affect the company's ability to continue to fund its operations within its loan facility.
A conference call will be held tomorrow, 25 August 2016 at 3:00 PM CEST (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:
Confirmation Code: 4376388
UK: +44(0)20 3427 1909
US: +1646 254 3361
DK: +4532 71 16 59
Following the conference call, a recording will be available on the company's website http://www.veloxis.com.
Source: Veloxis Pharmaceuticals A/S