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™ progressing according to plan.
Highlights:
- Veloxis development activities for LCP-Tacro™ 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® 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™ 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™ tablets leads to a measurable improvement in tremor.
- The Company has met with EMA representatives to discuss the MAA filing for LCP-Tacro™ 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.
