Veloxis Pharmaceuticals Publishes Annual Report 2011

HORSHOLM, Denmark, March 7, 2012 /PRNewswire/ -- Veloxis Pharmaceuticals A/S (OMX: VELO) ('Veloxis') today published the annual report of Veloxis Pharmaceuticals A/S for the financial year 2011. 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 2011 published separately today.

Full Year 2011 Highlights

• Positive phase III results in the LCP-Tacro™ Trial in stable kidney transplant patients which met all primary efficacy and safety endpoints.

• Award of a DKK 3.9 million grant from The Danish National Advanced Technology Foundation to support development of an oral chemotherapy agent.

• Company name changed from LifeCycle Pharma.

• Licensing of US commercial Fenoglide® (fenofibrate) rights to Santarus and settlement of Impax patent litigation.

• Veloxis and Athena Drug Delivery Solutions Pvt. Ltd. partnership to develop, manufacture and commercialize Veloxis' investigational drug AtorFen™ (Fenofibrate-Atorvastin fixed dose combination) in certain emerging markets.

• During 2011, Veloxis had no revenue compared to DKK 1.5 million in 2010. Revenue in 2010 consisted of payments under Veloxis' collaboration agreements.

• Research and development costs increased by DKK 11.6 million, or by 5.5%, from DKK 210.4 million in 2010 to DKK 222.0 million in 2011. Research and development costs are mainly attributable to the two phase lll trials of LCP-Tacro™. These costs include the finalization of the phase lll study in kidney transplant patients (stable patients, Study 3001) along with costs associated with the ongoing phase lll study in kidney transplant patients (de novo patients, Study 3002).

• Administrative expenses decreased by DKK 4.4 million or by 8.4%, from DKK 52.2 million in 2010 to DKK 47.8 million in 2011. The reduction in cost is attributable to the continued focus on reducing overall cost.

• During 2011, Veloxis recognized DKK 252.6 million in net loss compared to DKK 274.2 million in 2010. The net loss is in line with management's expectations for 2011, which projected a net loss of DKK 250 - 280 million.

• As per 31 December 2011, the balance sheet reflects cash and cash equivalents of DKK 297.7 million compared to DKK 531.5 million as per 31 December 2010. The decrease in cash position reflects the changes in operating activities in 2011. The cash position is in line with management's expectations for 2011, which projected a cash position at the end of 2011 of DKK 250 - 300 million.

Conference Call

On 7 March, 2012, 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 76 25 Denmark

+44 (0) 1452 555 566 UK

+1 631 510 7498 USA

Access code 57134951

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 2011 Highlights

• Research and development cost were realized at DKK 61.8 million compared to DKK 48.3 million in same period in  2010, and DKK 43.1 million in the previous quarter.

• Administrative expenses were realized at DKK 11.4 million compared to DKK 13.4 million in same period in 2010, and DKK 12.6 million in the previous quarter.

• Operating loss amounted to DKK 73.1 million, while net loss was realized at DKK 68.2 million.

Outlook for 2012

Veloxis is expecting an operating loss of DKK 220 – 250 million compared to the realized operating loss of DKK 270 million in 2011. The net loss is likewise expected to be in the range of DKK 220 – 250 million compared to the net loss of DKK 253 million in 2011. As of 31 December 2011, the Company's cash position equaled DKK 298 million and the Company's 31 December 2012 cash position is expected to be in the range of DKK 40 - 80 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. The outlook for 2012 does not include any effect from eventual milestone, royalty or partner arrangements.

Management is focused on securing additional funds beyond 2012 by either partner agreements, debt or equity, or a mix thereof.

Important events following the balance sheet date

On 4 January Veloxis announced Initiation of STRATO Study of LCP-Tacro™ in Kidney Transplant Recipients Experiencing Tremors. The STRATO 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 forward looking statements and targets contained herein are based on Veloxis Pharmaceuticals A/S' management's current view and assumptions. 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 Veloxis Pharmaceuticals A/S (Veloxis)

Based in Horsholm, Denmark, with an office in New Jersey, Veloxis is a specialty pharmaceutical company. Clinical development is the core of Veloxis' efforts to develop a product portfolio which includes the Company's lead product candidate, LCP-Tacro™, for immunosuppression, specifically organ transplantation, and products to combat certain cardiovascular diseases. Veloxis adapts new technologies on a fast commercial timetable. Veloxis' unique, patented delivery technology, MeltDose®, can improve absorption and bioavailability - at low-scale up costs - not only for a broad spectrum of drugs already on the market but also for new chemical entities. Veloxis has a lipid-lowering product, Fenoglide®, currently on the U.S. market and a diversified near and medium-term pipeline with three clinical stage product candidates and a number of projects in preclinical development. 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

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