Current Investment Highlights


  • Envarsus® has successfully demonstrated non-inferiority compared to tacrolimus (Prograf®; Astellas Pharma) in its Phase III clinical trial, Study 3002 by meeting its primary efficacy and primary safety endpoints
  • Positive results of Envarsus® Phase III "Switch" Study, Study 3001
  • Envarsus® (tacrolimus prolonged-release tablets) has received marketing authorization in the EU for prophylaxis of organ rejection in kidney and liver transplant recipients.
  • Exclusive distribution agreement with Chiesi Farmaceutici S.p.A for the commercialization and distribution of Envarsus® in certain countries, including Europe, Turkey and CIS countries
  • In the US, Envarsus® XR (tacrolimus extended-release tablets), has received Tentative Approval as a once-daily tablet version of tacrolimus for prophylaxis of organ rejection in kidney transplant patients in combination with other immunosuppressants.

 

2015 Outlook

  • Veloxis is expecting an operating loss of DKK 200 - 240 million compared to the realized operating loss of DKK 59 million in 2014.
  • Net loss is expected to be in the range of DKK 195 - 235 million compared to the net loss of DKK 36 million in 2014.
  • As of 31 December 2014, the Company’s cash position equaled DKK 270 million and the Company’s 31 December 2015 cash position is expected to be in the range of DKK 55 - 95 million.
  • The above estimates are assuming launch of Envarsus® XR in the US in the second half of 2015. The outlook is therefore subject to possible changes primarily related to the timing and outcome of the ongoing lawsuit regarding approval of Envarsus® XR.
  • Management is focused on securing additional funds beyond 2015 by either partner agreements, debt or equity, or a mix thereof.


Veloxis Pharmaceuticals A/S (OMX : VELO) 16:59 on Aug 28, 2015
Last Price Change Open Day High 52-Week High
1.04
0.02 down  (1.89%) 1.06 1.09 2.10
Volume Previous Close Day Low 52-Week Low
805,820 1.06 1.04 0.75