Zealand Interim Report For The First Nine Months Of 2016 (unaudited)

Glostrup, Denmark, Nov. 09, 2016 (GLOBE NEWSWIRE) -- Company announcement - No. 43 / 2016

Full year revenue guidance remains unchanged and expected lower net operating expenses               

Copenhagen, 9 November 2016 - Zealand Pharma A/S ("Zealand") (CVR no. 20 04 50 78) today reported financial results for the period, 1 January - 30 September 2016. The financial guidance on revenue for 2016 remains unchanged while the guidance on net operating expenses has been reduced.

Financial results for the first nine months of 2016
  • Revenue of DKK 54.3 million (164% increase vs. 2015)
  • Net operating expenses of DKK 220.9 million (25% increase vs. 2015)
  • Net loss of DKK 206.7 million (13% increase vs. 2015)
  • The cash position amounted to DKK 381.9 million at 30 September 2016 (30 September 2015: DKK 453.9 million). This excludes DKK 135.5 million in net proceeds raised in new share capital paid on 4 October 2016

Business highlights for Q3 2016:
  • Lixisenatide approved by the FDA as Adlyxin(TM) triggering a $5 million milestone
  • FDA regulatory decision on iGlarLixi in the U.S. extended to November 2016
  • Positive Phase II results for dasiglucagon for treatment of acute, severe hypoglycemia
  • Gross proceeds of DKK 143 million / $22 million were raised after a successful private placement of new shares to fund continued development of glepaglutide and dasiglucagon

Britt Meelby Jensen, President and CEO of Zealand , commented on the report:

"During the third quarter, we continued to advance our own clinical programs, with solid progress in patient recruitment for the glepaglutide Phase II trial and notably dasiglucagon with positive Phase II results for rescue treatment of acute severe hypoglycemia. In terms of our partnered programs, we are excited to have the first ever Zealand invented product approved in the U.S, the GLP-1 receptor agonist lixisenatide under the brand name Adlyxin TM . The FDA decision on iGlarLixi, the fixed-dose combination product with basal insulin, was extended by three months, from August to November, so we are close to reach this important milestone."

Out-licensed portfolio highlights

Adlyxin TM/Lyxumia ® (lixisenatide, GLP-1 receptor agonist)

Royalty revenue on Sanofi's sales of Lyxumia ® amounted to DKK 19.0 million / €2.6 million in the first nine months of 2016. Lyxumia ® is approved in more than 60 countries and has been launched by Sanofi in 45 of these.

In July 2016, lixisenatide was approved by FDA under the brand name Adlyxin(TM) which triggered a DKK 33.5 million / $5 million milestone payment from Sanofi.