- 2015 was a transitional year for Zealand with considerable business and pipeline advancements and a clear strategic direction set for accelerated value creation
- Strong Q4 with revenue of DKK 167 million / EUR 22 million and a net result of DKK 70 million / EUR 9 million
- Full year net result of DKK -114 million / EUR -15 million (2014: DKK -65 million / EUR -9 million) with revenues of DKK 188 million / EUR 25 million (2014: DKK 154 million / EUR 21 million) in line with guidance
- End 2015 cash position of DKK 440 million / EUR 59 million (2014: DKK 538 million / EUR 72 million), excluding the milestone of DKK 137 million / EUR 18 million from Sanofi in December, which was paid only in January 2016
- Key business events in Q4 2015 and the period thereafter:
- The fixed-ratio combination of lixisenatide and Lantus(r) (LixiLan) was submitted for US registration with use of a priority review voucher by Sanofi, triggering a USD 20 million payment to Zealand. FDA accepted the file in February 2016
- An FDA Advisory Committee Meeting on lixisenatide and the fixed-ratio combination of lixisenatide and Lantus(r) has been scheduled for May 2016
- Patient enrolment completed in Phase IIb trial with elsiglutide by Helsinn
- Two new lead drug candidates advanced into preclinical development under collaborations with Boehringer Ingelheim: One in October 2015 with an associated EUR 3 million payment to Zealand, and one in February 2016
- Two proprietary medicines have advanced into Phase II: ZP4207 for severe hypoglycemia and ZP1848 for short bowel syndrome
- Results from well-conducted Phase II Proof-of-Concept trial showed no effect of danegaptide on reducing cardiac reperfusion injuries
- Appointment of Andrew Parker as new Senior Vice President and Chief Science Officer with effect from 1 July 2016
COPENHAGEN, Denmark, March 16, 2016 (GLOBE NEWSWIRE) -- Zealand Pharma A/S ("Zealand") (CVR no. 20 04 50 78) announces financial results in line with guidance and considerable progress for its product portfolio and business for the twelve month period from 1 January to 31 December 2015.
Commenting on Zealand's full year results and the Annual Report for 2015, Britt Meelby Jensen, President and CEO of Zealand , said:
"2015 was one of the best years in the history of Zealand. Financial results were as expected with considerable financing from milestone payments, and our business and portfolio have substantially progressed. Under our agreement with Sanofi, both lixisenatide and LixiLan have been filed for approvals in the US with regulatory decisions expected in July and August, respectively. These milestones are decisive for the prospects of Zealand becoming a profitable company near term. We have also advanced and expanded our own proprietary pipeline, including the initiation of Phase II trials with two new lead drug candidates, a glucagon analogue for hypoglycemia and a GLP-2 analogue for short bowel syndrome. These advancements support our new strategy for accelerated value creation, in that we will take select specialty peptide medicines all the way through registration ourselves and thereby retain more value and control for the benefit of both patients and our shareholders."
And she continued : "As we expand and invest more in advancing our own investigational medicines, we will obviously increase our operating expenses. We remain mindful that this increase will largely be offset by growing royalty revenue and that Zealand retains a solid cash position. We have had a great start to 2016 and it is with confidence that I look further into another exciting year with a strong news flow and further growth of our business."
Source: Zealand Pharma A/S