OREANDA-NEWS. Zealand Pharma A/S today reported financial results for the half-year period 1 January - 30 June 2016. Results were as expected and the financial guidance for 2016 remains unchanged.

Britt Meelby Jensen, President and CEO of Zealand , commented on the report:
"This has been an exciting period for Zealand. We report financial results as expected, we confirm our full-year guidance, and we have had important advancements in our product portfolio. Lixisenatide, with the U.S. brand name AdlyxinTM, received FDA approval to treat adults with type 2 diabetes. Despite the recently announced three months' extension to the FDA review time for iGlarLixi, I expect 2016 to become the most successful year for Zealand, with an anticipated approval of this product in the U.S. as well. I am pleased with the continuously strong momentum in the development of our own product candidates. We have had positive Phase II results with our single-dose dasiglucagon, or ZP4207, for acute, severe hypoglycemia and we are in preparations to start the next clinical trial of multiple-dose dasiglucagon in a dual-hormone artificial pancreas system. Finally, our Phase II trial with glepaglutide[2], or ZP1848, for short bowel syndrome is progressing well."

Financial highlights for H1 2016

  • Revenue of DKK 14.7million / €2.0 million (H1 2015: DKK 13.3 million / €1.8 million).
  • Net operating expenses of DKK 165.4 million / €22.2 million (H1 2015: DKK 125.9 million / €16.9 million).
  • Net loss of DKK 175.7 million / €23.6 million (H1 2015: DKK 131.8 million / €17.7 million).
  • The cash position amounted to DKK 423.2 million / €56.8 million at 30 June 2016 (30 June 2015: DKK 468.6 million / €62.8 million).

Restatements
In connection with the preparation of the interim report for the first half of 2016, Zealand reviewed its accounting policy related to functional currency, income tax benefit and its royalty bond, along with reviewing a number of other items including the presentation of certain items within the statement of financial position. This review led to a number of restatements impacting the prior period income statements, statements of comprehensive loss, statement of cash flow, statement of financial position and statement of changes in equity.

The restatements have had a total impact on net loss and total comprehensive loss for the three and six months ended 30 June 2015 of respectively DKK -1.7 million and DKK 0.8 million. The restatements have had no impact on net loss or total comprehensive loss for the year ended 31 December 2015.

The nature and impact of the restatements are described in further details in Note 1 of the condensed consolidated interim financial statements.

Portfolio of out-licensed products - First product approved in the U.S.

AdlyxinTM/Lyxumia® (lixisenatide) for type 2 diabetes (license collaboration with Sanofi)

  • Royalty revenue to Zealand on Sanofi's sales of Lyxumia® amounted to DKK 13.1 million / € 1.7 million in H1 2016, a decrease of 3% compared to the same period of 2015. Sanofi reported flat sales of Lyxumia® for the period measured at constant exchange rates. Lyxumia® is approved in more than 60 countries and has been launched by Sanofi in 42 of these. The biggest markets for Lyxumia® are the UK, Spain, Italy and Japan. Additional launches are planned for 2016-2018.
  • Late July, lixisenatide was approved by the U.S. FDA under the brand name AdlyxinTM for the treatment of adults with type 2 diabetes. This triggered a $5 million milestone payment from Sanofi.  

iGlarLixi (fixed-ratio combination of lixisenatide and Lantus®) for type 2 diabetes (license collaboration with Sanofi)

  • On 19 August 2016, the U.S. FDA decided to extend the regulatory review time for Sanofi's New Drug Application (NDA) for iGlarLixi by three months. The decision followed the submission by Sanofi of additional information, requested by the FDA, on the pen device for delivery of iGlarLixi as part of the NDA. A U.S. regulatory decision on iGlarLixi is now expected before the end of November 2016.
  • In May 2016, the Endocrinologic and Metabolic Drugs Advisory Committee (EMDAC) of the FDA recommended, by a vote of 12 to 2, the approval of the NDA for iGlarLixi.
  • iGlarLixi is also undergoing review by the European Medicines Agency (EMA) with a regulatory decision for Europe expected in Q1 2017.

Elsiglutide (GLP-2 analog) for chemotherapy-induced diarrhea (license collaboration with Helsinn)                                                                                                                                                          

  • In May 2016, a Phase IIb trial of elsiglutide for the treatment of chemotherapy induced diarrhea failed to meet its primary endpoint.
  • Helsinn is evaluating the full Phase II data set as well as results from a large, observational study of chemotherapy-induced diarrhea in consideration of next possible steps in the development of elsiglutide. A decision is expected later in H2 2016.

Boehringer Ingelheim license agreements - Novel treatments for diabetes and obesity

  • Zealand has two therapeutic peptide projects under license collaborations with Boehringer Ingelheim. One covers glucagon/GLP-1 dual agonists for the treatment of diabetes and/or obesity, and the other covers novel compounds against an undisclosed biological target for the treatment of obesity and/or diabetes.
  • Under both collaborations a lead candidate is being progressed towards start of clinical Phase I development in 2017.

Progress in the pipeline of proprietary drug candidates

Glepaglutide[3] (ZP1848, long-acting GLP-2 analog) for short bowel syndrome

  • In June 2016, glepaglutide was proposed as an International Non-proprietary Name for Zealand's proprietary GLP-2 analog, previously known as ZP1848.
  • The ongoing Phase II Proof-of-Concept trial is progressing according to plan, with results expected mid-2017.

Dasiglucagon[4] (ZP4207, glucagon analog) for single-dose rescue treatment of severe hypoglycemia in diabetes                                                                                 

  • In August 2016, Zealand announced results from a clinical Phase II trial with dasiglucagon, supporting its potential as a ready-to-use rescue pen to treat acute, severe hypoglycemia ("insulin shock") associated with insulin therapy in diabetes. 
  • Zealand initiated the trial in February 2016 and completed the enrolment of 58 patients with type 1 diabetes in June 2016.
  • The full results from the Phase II trial are planned for discussion with the FDA later in 2016 to define the next development steps for dasiglucagon as a rescue treatment.  

Dasiglucagon[5] (ZP4207, glucagon analog) for multiple-dose use in dual-hormone artificial pancreas for better diabetes management                                                                                                    

  • In June 2016, a non-exclusive collaboration was announced with U.S. based Beta Bionics. The objective is to advance the development of a first-in-class dual-hormone artificial pancreas system to offer diabetes patients on insulin therapy, an easier and better way to control and manage their disease.
  • A next clinical trial is expected to be initiated later in 2016.

Other business

  • As of 1 July 2016, Zealand's senior management team has been expanded and strengthened with the arrival of Andrew Parker as the company's new Chief Science Officer.