Veloxis Pharmaceuticals A/S
Veloxis Pharmaceuticals announces financial results for the first three months of 2015

DGAP-News: Veloxis Pharmaceuticals A/S

2015-05-20 / 17:14

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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(R) 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(R)
     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(R) 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(R) 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' s
ales 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.
News Source: NASDAQ OMX



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2015-05-20 Dissemination of a Corporate News, transmitted by DGAP - a
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Language:    English                      
Company:     Veloxis Pharmaceuticals A/S  
 
 
             Denmark                      
ISIN:        DK0060048148                 
 
 
End of News    DGAP News-Service  
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