Veloxis Pharmaceuticals publishes Annual Report 2015

Company Announcement no. 2/2016

To: NASDAQ OMX Copenhagen A/S                                                         Hørsholm, Denmark, 9 March 2016

Veloxis Pharmaceuticals publishes Annual Report 2015

Veloxis Pharmaceuticals A/S (OMX: VELO) (‘Veloxis’) today published the annual report of Veloxis Pharmaceuticals A/S for the financial year 2015, and has entered into a long-term loan and security agreement.

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 2015 published separately today.

Highlights

• Craig A. Collard has been hired as President and CEO. Craig A. Collard has more than 20 years’ track record of strategic and tactical leadership within the pharmaceutical industry. He replaces William J. Polvino.

• FDA approval of Envarsus® XR for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from other twice-daily tacrolimus products to once-daily Envarsus® XR.

• Envarsus® XR was granted Orphan Drug status by the U.S. Food and Drug Administration (FDA) for prophylaxis of organ rejection in patients who convert from immediate-release tacrolimus.

• U.S. launch of Envarsus® XR (tacrolimus extended-release tablets) for the prophylaxis of rejection in kidney transplant patients who require or desire conversion from immediate release tacrolimus products to once-daily Envarsus® XR.

• Veloxis has entered into a five-year loan and security agreement with Lundbeckfond invest A/S and Novo A/S for up to USD 20 million in financing.  The facility mat be utilized in tranches and repaid without penalty.  It carries a 9.25% interest rate, payable annually in arrears.

• Top-line results of the ASTCOFF study, A STeady-state Pharmacokinetic COmparison Of all Formulations, demonstrating that once-daily Envarsus® XR achieved differentiated pharmacokinetics (PK) when compared to twice-daily tacrolimus (Prograf®) or a once-daily tacrolimus product (Astagraf XL®).

• Once-daily Envarsus® XR demonstrated that a lower dose of once-daily Envarsus XR in African-American kidney transplant patients is sufficient to achieve therapeutic tacrolimus blood concentrations, compared to twice-daily immediate release tacrolimus.

• During 2015, Veloxis recognized revenue from commercial sales of DKK 14.2 million compared to DKK 3.2 million in 2014. Revenue in 2014 also consist of DKK 120.2 million of up-front and milestone payments under Veloxis’ distribution agreement with Chiesi Farmaceutici S.p.A.

• Sales and marketing costs increased from DKK 41.3 million in 2014 to DKK 66.2 million in 2015. This reflects the hiring and building of the marketing and sales infrastructure in the U.S. Envarsus® XR was launched in the U.S. in December 2015.

• Research and development costs decreased from DKK 90.1 million in 2014 to DKK 76.3 million in 2015. The reduction in cost is associated with the overall reduction in study activity as studies are being completed.

• Administrative expenses increased from DKK 47.4 million in 2014 to DKK 53.6 million in 2015.

• During 2015, Veloxis recognized DKK 176.1 million in net loss compared to DKK 36.3 million in 2014. The net loss is in line with management’s expectations for 2015 as reported on 26 August 2015 in connection with the second quarter interim report, which projected a net loss of DKK 155 - 185 million.

• As per 31 December 2015, the balance sheet reflects cash and cash equivalents of DKK 107.7 million compared to DKK 270.4 million as per 31 December 2014. The decrease in cash position reflects the changes in operating activities in 2015. The cash position is in line with management’s expectations for 2015, which projected a cash position at the end of 2015 of DKK 100 - 130 million.

• We expect an operating loss in 2016 of DKK 120 - 160 million compared to the realized operating loss of DKK 197 million in 2015. The Net loss in 2016 is expected to be in the range of DKK 120 - 160 million compared to the net loss of DKK 176 million in 2015.

Conference Call

On 9 March, 2016, Veloxis’ Management will host a conference call, at 3:00 PM CET (Denmark); 2:00 PM GMT (London), 9:00 AM ET (New York).

To access the live conference call, please dial one of the following numbers:

+45 38 32 28 69 Denmark

+44 (0) 20 3427 0503 UK

+1 646 254 3361 USA

Access code 6300894

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’).

Vedhæftede filer:

090316 Veloxis anounces annual report 2015.pdf

Veloxis annual report 2015.pdf