3/5/2014 10:39:53 AM
HORSHOLM, Denmark, March 5, 2014 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) ('Veloxis') today published the annual report of Veloxis Pharmaceuticals A/S for the financial year 2013. 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 2013 published separately today.
Full Year 2013 Highlights
- Submitted a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) seeking approval for the marketing and sale of Envarsus® for the prevention of organ rejection in kidney transplant recipients.
- Granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prophylaxis of organ rejection in patients receiving allogenic kidney transplants. The designation is to encourage the development of drugs that may provide significant benefit to patients suffering from rare diseases.
- Dosing of the first patient in ASERTAA (A Study of Extended Release Tacrolimus in African-Americans) Phase IIIb study of Envarsus® in kidney transplant recipients. The ASERTAA study is designed to compare the pharmacokinetics (PK) of Envarsus®, a once-daily tacrolimus tablet, to generic twice daily tacrolimus capsules in stable African-American renal transplant patients.
- The trade name for LCP-Tacro is Envarsus®.
- Envarsus® successfully demonstrated non-inferiority compared to tacrolimus (Prograf®; Astellas Pharma) in its Phase III clinical trial, Study 3002. The Phase III randomized, double-blind and double-dummy study in 543 de novo kidney transplant recipients, with Prograf® as the comparator, met its primary efficacy and primary safety endpoints.
- The European Medicines Agency (EMA) accepted for review the company's Marketing Authorization Application (MAA) to market Envarsus® for the prevention of organ rejection in kidney transplant patients in the European Union. Veloxis expects the decision from the European Union in 2014.
- Data from the STRATO study demonstrates the potential for Envarsus® to improve tacrolimus-induced tremors in stable kidney transplant patients.
- Submitted a Marketing Authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market Envarsus® for the prevention of organ rejection in kidney transplant patients in the European Union.
- During 2013, Veloxis recognized deferred revenue of DKK 38.2 million as revenue compared to DKK 6.9 million in 2012. Deferred revenue consist of up-front and milestone payments under Veloxis' distribution agreement with Chiesi Farmaceutici S.p.A. and is recognized in the income statement based on planned development periods.
- Research and development costs decreased by DKK 64.2 million, or by 30.5%, from DKK 210.7 million in 2012 to DKK 146.5 million in 2013. Research and development costs are mainly attributable to the phase III trial in Envarsus® (de novo patients, Study 3002). The reduction in cost between the two periods is mainly related to effect from the executed restructuring and discontinuation of other pipeline activities in May 2012.
- Administrative expenses decreased by DKK 9.1 million or by 24.7%, from DKK 36.9 million in 2012 to DKK 27.8 million in 2013. 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.
- During 2013, Veloxis recognized DKK 139.3 million in net loss compared to DKK 262.7 million in 2012. The net loss is better than management's expectations for 2013 as reported on 13 November 2013 in connection with the third quarter interim report, which projected a net loss of DKK 160 - 190 million. The positive deviation is mainly driven by the granted orphan drug status which has reduced regulatory costs.
- As per 31 December 2013, the balance sheet reflects cash and cash equivalents of DKK 328.7 million compared to DKK 496.8 million as per 31 December 2012. The decrease in cash position reflects the changes in operating activities in 2013. The cash position is in line with management's expectations for 2013, which projected a cash position at the end of 2013 of DKK 310 - 340 million.
On 5 March, 2014, Veloxis' Management will host a conference call, at 2:00 PM CET (Denmark); 1:00 PM GMT (London), 8:00 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 1728236
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').
Research and development costs
Operating loss before restructuring cost
Net financial income / (expenses)
Loss before tax
Tax for the period
Net loss for the period
Cash and cash equivalents
Investment in property, plant and equipment
Cash Flow Statement
Cash flow from operating activities
Cash flow from investing activities
Cash flow from financing activities
Cash and cash equivalents at period end
Basic and diluted EPS (DKK)
Weighted average number of shares
Average number of employees (FTEs)
Fourth Quarter 2013 Highlights
- Research and development cost were realized at DKK 29.5 million compared to DKK 41.9 million in same period in 2012, and DKK 35.2 million in the previous quarter.
- Administrative expenses were realized at DKK 6.5 million compared to DKK 10.2 million in same period in 2012, and DKK 6.7 million in the previous quarter.
- Operating loss amounted to DKK 23.8 million, while net loss was realized at DKK 24.7 million.