Veloxis Pharmaceuticals announces financial results for the first half 2012, anticipated financing, revised EU regulatory filing strategy and revised outlook for 2012.

Veloxis Pharmaceuticals A/S 

22.08.2012 18:30

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Company Announcement no. 11/2012



To: NASDAQ OMX Copenhagen A/S                                                  
                           Hørsholm, Denmark, 22 August, 2012 





  Veloxis Pharmaceuticals announces financial results for the first half 2012,
anticipated financing, revised EU regulatory filing strategy and revised outlook
  for 2012.  Phase III activities for LCP-Tacro(TM) progressing according to plan.

                                        

Highlights:

  -- Veloxis development activities for LCP-Tacro(TM) are proceeding in line with
     expectations.  Enrollment has been completed in the pivotal LCP-Tacro 3002
     Phase III study in de novo kidney transplant patients. The LCP-Tacro 3002
     study is designed to demonstrate non-inferiority versus standard therapy
     Prograf(R) and 543 patients have been randomized at approximately 90 clinical
     sites around the world.  Results are expected mid-2013.

  -- Veloxis STRATO Study of LCP-Tacro(TM) in Kidney Transplant Recipients
     Experiencing Tremors is progressing according to plan. The study is
     designed to explore whether a conversion of patients who have symptomatic
     tremor from treatment with standard immediate release twice-daily
     tacrolimus capsules to extended release once-daily LCP-Tacro(TM) tablets leads
     to a measurable improvement in tremor.

  -- The Company has met with EMA representatives to discuss the MAA filing for
     LCP-Tacro(TM) and have agreed to defer filing to 2013.

  -- Veloxis is announcing its intent to obtain further financing through a
     rights issue, anticipated to be launched in the fourth quarter of 2012, to
     raise gross proceeds of approximately DKK 425 million. The Company's two
     largest shareholders, Lundbeckfond Invest A/S and Novo A/S, have expressed
     their intention to support the financing.  Based on the support expressed
     by the major shareholders the Company expects that the share price of the
     offering will be no less than DKK 0.35.

  -- The Company intends in late August to call an EGM for September to approve
     the proposed financing. Detailed information to shareholders will be
     included in the notice convening the EGM in late August.

  -- Veloxis reported a net loss of DKK 160.6 million for the first half of 2012
     compared to a net loss of DKK 141.2 million for the same period in 2011.
Veloxis announces revised outlook for 2012.

  -- For the first half of 2012, Veloxis' research and development costs
     amounted to DKK 119.5
 million compared to DKK 117.2 million during the same period in 2011.

  -- On 30 June, 2012, Veloxis had cash and cash equivalents of DKK 152.7
     million.



Outlook for 2012

Veloxis changes its 2012 outlook from previously announced DKK 220 - 250 to DKK
240 - 270 million in operating loss due to restructuring cost incurred in the
second quarter of 2012. The Company's cash and cash equivalents position as at
31 December, 2012 is maintained as announced in the annual report for 2011, and
is expected to be in the range of DKK 40-80 million. The outlook is without
giving the effect to the planned financing anticipated during the fourth
quarter 2012. 



Financial calendar for 2013

6 March, 2013:                             Release of Annual Report 2012.

17 April, 2013:                              Annual General Meeting.

15 May, 2013:                              Interim Report for the 1st Quarter ‐
for the period 1 January to 31 March, 2013. 

21 August, 2013:                          Interim Report for the 2nd Quarter -
for the period 1 January to 30 June, 2013. 

13 November, 2013:                     Interim Report for the 3rd Quarter - for
the period 1 January to 30 September, 2013. 





Conference call

A conference call will be held tomorrow, 23 August, 2012 at 8:00 AM CET
(Denmark); 7:00 AM GMT (London). 



To access the live conference call, please dial one of the following numbers:

+45 32 72 76 25 (Denmark)

+44 (0) 1452 555 566 (UK)

+1 631 510 7498 (USA)

Access code 21465742



Following the conference call, a recording will be available on the company's
website http://www.veloxis.com.
News Source: NASDAQ OMX



22.08.2012 DGAP's Distribution Services include Regulatory Announcements,
Financial/Corporate News and Press Releases.
Media archive at www.dgap-medientreff.de and www.dgap.de

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Language:     English
Company:      Veloxis Pharmaceuticals A/S
              
               
              Denmark
Phone:        
Fax:          
E-mail:       
Internet:     
ISIN:         DK0060048148
WKN:          
 
End of Announcement                             DGAP News-Service
 
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