HORSHOLM, Denmark, Nov. 11, 2015 /PRNewswire/ --
Highlights:
- On 30 September, 2015, Veloxis had cash and cash equivalents of DKK 157.6 million, and the Company’s cash position is expected to be in the range of DKK 100 130 million at year-end. The Company is currently engaged in a process to secure additional financing primarily through debt structure. The Company expects that the financing cost will be in the range of a high yield bond for similar life science companies and the proceeds will be used primarily to support US product launch.
- On 14 October, 2015, a sponsored Level 1 American depositary receipt (ADR) program in the U.S. was established. The ADR trades under the symbol VXPZY.
- Envarsus® XR has been issued a unique reimbursement J-code by the Centers for Medicare and Medicaid Services (CMS) for 2016 onwards.
- Envarsus® XR has been 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.
- Veloxis has received U.S. Food and Drug Administration (FDA) approval of Envarsus® XR (tacrolimus extended-release tablets) 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. Veloxis expects Envarsus® XR to be available to patients in the United States and their physicians by the end of 2015.
- Veloxis reported a net loss of DKK 114.3 million for the nine months of 2015 compared to a net profit of DKK 12.9 million for the same period in 2014. The reported net loss is in line with expectations.
- For the first nine months of 2015, Veloxis recognized revenue of DKK 13.0 million compared to DKK 120.2 million in the same period of 2014. Revenue in 2015 consist of commercial sales to Chiesi Farmaceutici S.p.A. Revenue in 2014 consist of up-front and milestone payments under Veloxis’ distribution agreement with Chiesi Farmaceutici S.p.A. Envarsus is currently launched in Germany, Netherlands, UK, Denmark, Austria, Ireland, France, Slovenia and the Czech Republic.
- For the first nine months of 2015, Veloxis’ sales and marketing costs amounted to DKK 40.9 million compared to DKK 24.0 million during the same period in 2014. Research and development costs amounted to DKK 56.0 million compared to DKK 70.4 million during the same period in 2014.
Outlook for 2015
Veloxis maintains its 2015 outlook with an operating loss in the range of DKK 175 - 205 million, and a net loss in the range of DKK 155 - 185 million for the financial year 2015.
On 30 September 2015, the Company’s cash position equaled DKK 157.6 million, and on 31 December 2015, the Company’s cash position is expected to be in the range of DKK 100 130 million.
Conference call
A conference call will be held tomorrow, 12 November, 2015 at 3:00 PM CET (Denmark); 2:00 PM GMT (London), 9:00 AM EST (New York).
To access the live conference call, please dial one of the following numbers:
+45 38 48 75 13 (Denmark)
+44 (0) 20 7136 2055 (UK)
+1 718 354 1359 (USA)
Access code 1720884
Following the conference call, a recording will be available on the company’s website http://www.veloxis.com.
Business update
Envarsus® Market and Regulatory Strategy
On 28 July, 2014, it was announced that the European Commission granted marketing authorization for Envarsus® for the prevention of organ rejection in adult kidney and liver transplant patients in the European Union (EU). Veloxis’ marketing and distribution partner in EU Chiesi Farmaceutici launched Envarsus® in late 2014, with launches in Germany and the Netherlands, followed by launch in the UK, Denmark, Austria, Eire, France, Slovenia and the Czech Republic in 2015. Additional launches are anticipated for the majority of the major EU countries during 2015 and into 2016, once local requirements such as pricing and reimbursement negotiations have been completed.
On 12 June, 2015, Veloxis announced that the U.S. District Court for the District of Columbia had ruled in favor of the FDA in the lawsuit filed by Veloxis against the FDA. The Court’s ruling left intact FDA’s 30 October, 2014 tentative approval of Envarsus® XR (tacrolimus extended-release tablets), which delayed full approval for use in newly transplanted kidney transplant recipients (“de novo” patients). Veloxis submitted revised labeling to FDA with the goal of making Envarsus® XR available for kidney transplant patients who wish to convert from twice-daily tacrolimus products to once-daily Envarsus® XR.
On 10 July, 2015, Veloxis received U.S. FDA approval of Envarsus® XR (tacrolimus extended-release tablets) 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 has been issued a unique reimbursement J-code by the Centers for Medicare and Medicaid Services (CMS) for 2016 onwards. J-codes are used by providers to identify drugs to help facilitate reimbursement.
The build and hiring of the full commercial infrastructure, including a sales team of approximately 18 individuals to call on the top 120 transplant centres in the US, to support launch of Envarsus® XR in the US is nearly complete and expected to be in place and operational for product launch in late 2015. The initial sales uptake in the US is expected to be gradual but steady as patients are converted from existing therapies to Envarsus XR.
In addition, Envarsus® XR has been 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.
Envarsus® study programme
Veloxis is conducting a series of Phase IIIb/IV studies to further evaluate potential differences in clinical profile provided by Envarsus®' unique PK profile.
To read full press release, please click here.
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