Veloxis Pharmaceuticals publishes Annual Report 2012

HORSHOLM, Denmark, March 6, 2013 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) ('Veloxis') today published the annual report of Veloxis Pharmaceuticals A/S for the financial year 2012. The annual report has been prepared in accordance with International Financial Reporting Standards as adopted by the EU and additional Danish disclosure requirements for annual reports of listed companies.

This company announcement should be read in conjunction with Veloxis' annual report 2012 published separately today.

Full Year 2012 Highlights

• Enrollment completed in the pivotal LCP-Tacro™ Phase III study in de novo kidney transplant patients.
• Restructuring of the company's operations in order to fully focus its resources on the completion of the development and subsequent commercialization of LCP-Tacro™.  Other pipeline activities will be discontinued, including early phase research activities.
• Exclusive distribution agreement with Chiesi Farmaceutici S.p.A. for the commercialization and distribution of its novel formulation immunosuppressant drug candidate LCP-Tacro™ in certain countries, including Europe, Turkey and CIS countries (Russia and former USSR republics). Under the terms of the agreement, Veloxis will receive up-front and milestone payments of up to USD 47.5 million (in aggregate). The milestone payments are subject to the achievement of certain regulatory milestones and sales targets.
• Fully subscribed rights issue of 1,206,779,946 offer shares with a nominal value of DKK 0.10 each at DKK 0.35 per share has been completed. The net proceeds from the rights issue is DKK 409 million.
• Results of a preliminary analysis from the first 16 patients in its Switching STudy of Kidney TRansplant PAtients with Tremor to LCP-TacrO (STRATO) clinical trial. Results from the first 16 patients demonstrated a trend toward a reduction in tremor following the switch from twice-daily tacrolimus to once-daily LCP-Tacro™.
• During 2012, Veloxis recognized DKK 6.9 million in revenue compared to no revenue in 2011. Revenue in 2012 consist of up-front and milestone payments under Veloxis' distribution agreement with Chiesi Farmaceutici S.p.A.
• Research and development costs decreased by DKK 11.3 million, or by 5.1%, from DKK 222.0 million in 2011 to DKK 210.7 million in 2012. Research and development costs are mainly attributable to the ongoing phase III trial in LCP-Tacro™ (de novo patients, Study 3002).
• Administrative expenses decreased by DKK 10.9 million or by 22.9%, from DKK 47.8 million in 2011 to DKK 36.9 million in 2012. The reduction in cost is attributable to the continued focus of reducing overall cost, combined with the effect of the reduction in the number of employees that took place in May 2012.
• Restructuring cost includes salary payments to former employees in connection with the reduction in headcount in May 2012 and a write-down of laboratory equipment and laboratory improvements due to the discontinuation of pipeline activities not related to LCP-Tacro™.
• During 2012, Veloxis recognized DKK 262.7 million in net loss compared to DKK 252.6 million in 2011. The net loss is in line with management's expectations for 2012 as reported on 22 August 2012 in connection with the second quarter interim report, which projected a net loss of DKK 240 - 270 million.
• As per 31 December 2012, the balance sheet reflects cash and cash equivalents of DKK 496.8 million compared to DKK 297.7 million as per 31 December 2011. The increase in cash position reflects the total net proceeds from the offering of DKK 409 million, partially offset by expenditures associated with the operating activities in 2012. The cash position is in line with management's expectations for 2012, which projected a cash position at the end of 2012 of DKK 490 - 530 million.

Conference Call

On 6 March, 2013, Veloxis' Management will host a conference call, at 2:00 PM CET (Denmark); 1:00 PM GMT (London), 8:00 AM ET (New York), 5:00 AM PT (San Francisco).

To access the live conference call, please dial one of the following numbers:
+45 32 72 80 18 Denmark
+44 (0) 1452 555 131 UK
+1 866 682 8490 USA
Access code 13759590

Following the conference call, a recording will be available on the company's website www.veloxis.com. A presentation will be available on Veloxis' website (under 'Investors') one hour prior to the scheduled time of the conference call.

Fourth Quarter 2012 Highlights

• Research and development cost were realized at DKK 41.9 million compared to DKK 61.8 million in same period in  2011, and DKK 49.4 million in the previous quarter.

• Administrative expenses were realized at DKK 10.2 million compared to DKK 11.4 million in same period in 2011, and DKK 7.0 million in the previous quarter.

• Operating loss amounted to DKK 45.3 million, while net loss was realized at DKK 46.5 million.

Outlook for 2013

Veloxis is expecting an operating loss of DKK 170 - 200 million compared to the realized operating loss of DKK 262 million in 2012. The net loss is likewise expected to be in the range of DKK 170 - 200 million compared to the net loss of DKK 263 million in 2012. As of 31 December 2012, the Company's cash position equaled DKK 497 million and the Company's 31 December 2013 cash position is expected to be in the range of DKK 270 - 310 million.

The above estimates are subject to possible changes primarily due to the timing and variation of clinical activities, related costs, royalty and other partner income, and fluctuating exchange rates.

Important events following the balance sheet date
Following the balance sheet date no material events have occurred.

About LCP-Tacro™ and tacrolimus
Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. LCP-Tacro™ is an investigational drug that is being developed as a once-daily tablet version of tacrolimus, with improved bioavailability, consistent pharmacokinetic performance and reduced peak-to-trough variability when compared to currently approved tacrolimus products. Transplant patients need to maintain a minimum blood level of tacrolimus for the prevention of transplant allograft rejection, but excessive levels may increase the risk of serious side effects such as nephrotoxicity, tremor, diabetes, high blood pressure, and opportunistic infections. Therefore, tacrolimus levels need to be managed carefully, and transplant patients are typically obliged to make frequent visits to the hospital for monitoring and dose adjustments after receiving a new organ.

About Veloxis Pharmaceuticals
Based in Horsholm, Denmark, with an office in New Jersey, Veloxis Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. The company's lead product candidate is LCP‐Tacro™ for immunosuppression, specifically organ transplantation. Veloxis' unique, patented delivery technology, MeltDose®, can improve absorption and bioavailability at low‐scale up costs.  Veloxis has a lipid lowering product, Fenoglide®, currently on the U.S. market that is commercialized through partner Santarus, Inc. Veloxis is listed on the NASDAQ OMX Copenhagen under the trading symbol OMX: VELO. 

For further information, please visit www.veloxis.com.

SOURCE Veloxis Pharmaceuticals A/S