Veloxis Pharmaceuticals publishes Annual Report 2014

HORSHOLM, Denmark, March 3, 2015 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) ('Veloxis') today published the annual report of Veloxis Pharmaceuticals A/S for the financial year 2014. 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 2014 published separately today.

Full Year 2014 Highlights

• Filed an action against the FDA, seeking an order requiring FDA to grant final approval to Envarsus® XR.
• FDA has informed Veloxis of a tentative approval of Envarsus® XR. FDA stated that the final approval of Envarsus® XR will be delayed until expiration of the exclusivity period for Astellas' Astagraf XL®. Veloxis understands that this expiry is anticipated to occur July 19, 2016.
• The European Commission (EC) has granted marketing authorization for Envarsus® for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU).
• Once-daily Envarsus® XR (tacrolimus extended-release tablets), demonstrated a lower treatment failure rate in African-Americans compared with twice-daily tacrolimus (Prograf®).
• Two-year results of the pivotal Phase 3 clinical trial, Study 3002, of Envarsus® XR (tacrolimus extended-release tablets) in de novo kidney transplant patients continued to demonstrate non-inferiority compared to tacrolimus capsules (Prograf®; Astellas Pharma).
• The FDA has accepted for standard review the company's New Drug Application (NDA) for Envarsus® for the prevention of organ rejection in adult kidney transplant patients.
• United States Patent and Trademark Office had issued a Notice of Allowance for U.S. Application Serial Number 13/167,420, a patent which covers the diurnal-independent administration of Envarsus®.
• During 2014, Veloxis recognized revenue from deferred upfront, milestone payments and commercial sales of DKK 123.4 million compared to DKK 38.2 million in 2013.
• Sales and marketing costs amounted to DKK 41.3 million in 2014. This reflects the hiring and building of the marketing and sales infrastructure.
• Research and development costs decreased by DKK 56.4 million, or by 38.5%, from DKK 146.5 million in 2013 to DKK 90.1 million in 2014. Research and development costs are mainly attributable to the phase III trial in Envarsus® (de novo patients, Study 3002). The reduction in cost is associated with the overall reduction in study activity as some studies have now been completed.
• Administrative expenses increased from DKK 27.8 million in 2013 to DKK 47.4 million in 2014. The increase in cost is mainly attributable to legal fees in connection with legal actions against the FDA.
• During 2014, Veloxis recognized DKK 36.3 million in net loss compared to DKK 139.3 million in 2013. The net loss is in line with management's expectations for 2014 as reported on 12 November 2014 in connection with the third quarter interim report, which projected a net loss of DKK 20 - 50 million.
• As per 31 December 2014, the balance sheet reflects cash and cash equivalents of DKK 270.4 million compared to DKK 328.7 million as per 31 December 2013. The decrease in cash position reflects the changes in operating activities in 2014. The cash position is in line with management's expectations for 2014, which projected a cash position at the end of 2014 of DKK 255 - 285 million.

Conference Call
On 3 March, 2015, Veloxis' Management will host a conference call, at 4:00 PM CET (Denmark); 3:00 PM GMT (London), 10:00 AM ET (New York).

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 88916362

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').

Fourth Quarter 2014 Highlights

• Sales and marketing cost were realized at DKK 17.2 million compared to DKK 0 million in same period in 2013, and DKK 10.4 million in the previous quarter.
• Research and development cost were realized at DKK 19.7 million compared to DKK 29.5 million in same period in 2013, and DKK 19.4 million in the previous quarter.
• Administrative expenses were realized at DKK 19.4 million compared to DKK 6.5 million in same period in 2013, and DKK 10.3 million in the previous quarter.
• Operating result amounted to a loss of DKK 56.3 million, while net result was realized at a loss of DKK 49.2 million.

Outlook for 2015
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.

Important events following the balance sheet date
13 January, Veloxis announced that it has received notice from the FDA stating that FDA continues to take the position that the exclusivity for Astagraf XL should require delay in the formal approval of Envarsus® XR.

The forward looking statements and targets contained herein are based on the current view and assumptions of the Executive Management and the Board of Directors of Veloxis Pharmaceuticals A/S. Such statements involve known and unknown risks and uncertainties that may cause actual results, performance or events to differ materially from those anticipated herein. Veloxis Pharmaceuticals A/S expressly disclaim any obligation or undertaking to update or revise any forward looking statements, targets or estimates contained in this interim report to reflect any change in events, conditions, assumptions, or circulations on which any such statements are based unless  required by applicable law.

About Envarsus®
Tacrolimus is a leading immunosuppression drug used for the prevention of transplant allograft rejection after organ transplantation. Envarsus® (tacrolimus prolonged-release tablets) has received marketing authorization in the EU for prophylaxis of organ rejection in kidney and liver transplant recipients. In the US, Envarsus®, known as 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.  Envarsus® XR has received orphan drug designation in the U.S. Veloxis plans to commercialize Envarsus® XR in the US through its own sales force and in the EU through its partnership with Chiesi Farmaceutici SpA. 

About Veloxis Pharmaceuticals
Based in Horsholm, Denmark, with an office in New Jersey, Veloxis Pharmaceuticals A/S, or Veloxis, is a specialty pharmaceutical company. Veloxis' unique, patented delivery technology, MeltDose®, is designed to enhance the absorption and bioavailability of select orally administered drugs. 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

Related Links

http://www.veloxis.com