Business Strategy

The primary goal of Veloxis is to complete its ongoing Phase III clinical studies of LCP-Tacro, to obtain regulatory approval in the United States and the European Union, and then commercialize the product. The key elements of Veloxis’ business strategy are as follows:

• Advance LCP-Tacro through clinical studies and obtain regulatory approval within the organ transplantation area. LCP-Tacro (once-daily dosage) has received positive Phase II and Phase III clinical data in kidney transplant patients when compared head-to-head with Prograf (twice-daily dosage), the only non-generic tacrolimus product currently available on the U.S. market for prophylaxis of organ rejection following transplant. In addition, the Company has received positive Phase II data for LCP-Tacro in liver transplant patients when compared head-to-head with Prograf. The Company has elected to focus its development efforts on pursuing LCP-Tacro for treatment of kidney transplant patients, given the larger potential patient population and demand.

• Maximise the full value of the LCP-Tacro programme by funding in-house through the completion of Phase III, NDA/MAA submission and commercial launch. The Company initiated Phase III clinical studies for LCP-Tacro in stable kidney transplant patients in the second half of 2008 and in de novo kidney transplant patients in the fourth quarter of 2010. The de novo transplant study protocol received a Special Protocol Assessment (“SPA”) from the FDA, and completed enrolment of 543 patients in March 2012.

The Company intends to continue the development programme aiming at NDA/MAA submission and commercial launch, enabling the Company to execute its strategy of commercializing in the United States itself and through partnering arrangements in the rest of the world. This strategy is intended to maximise the full value of the programme.

Given the special characteristics of the organ transplant market, the field force required to market successfully in the transplant space is relatively small. Consequently, assuming successful completion of the Phase III programme, the Company currently plans to establish its own sales force in the United States. In relation to other jurisdictions, the Company has concluded a partnership agreement with Chiesi in respect of the commercialization of LCP-Tacro in certain countries, including Europe, Turkey and CIS Countries.

In April 2013, Veloxis submitted a marketing authorization Application (MAA) to the European Medicines Agency (EMA) seeking approval to market LCP-Tacro for the prevention of organ rejection in kidney transplant patients in the European Union.