Zealand reports results for the first three months of 2017 (unaudited)

Company announcement - No. 15 / 2017

Zealand reports results for the first three months of 2017 (unaudited)

Copenhagen, May 17, 2017 - Zealand Pharma A/S ("Zealand") (Company reg. No. 20 04 50 78) announces financial results in line with guidance and continued positive progress for its product portfolio and business for the three-month period from January 1 to March 31, 2017.

Financial results for the first three months of 2017

  • Revenue of DKK 77.6 million (6.7 million in Q1 2016), including milestone revenue of DKK 69.6 million.
  • Net operating expenses[1] of DKK 70.4 million (unchanged vs. Q1 2016).
  • Net result of DKK -26.3 million (-77.8 million in Q1 2016).
  • The cash position amounted to DKK 417.0 million at March 31, 2017 (December 31, 2016: 642.1 million). This includes restricted cash of DKK 6.7 million (December 31, 2016: 318.7 million) held as collateral for the royalty bond.

Business highlights for the first three months of 2017

  • Adlyxin® (lixisenatide) and Soliqua®100/33 (insulin glargine 100 units/ml and lixisenatide 33 mcg/ml injection) were launched by Sanofi in the U.S. in January, 2017.
  • Suliqua® was approved in the EU by the European Commission in January, 2017, triggering a USD 10 million milestone payment to Zealand from Sanofi.
  • Terms of the USD 50 million royalty bond renegotiated in 2017: 50% or DKK 175 million (USD 25 million) was repaid and restricted cash of DKK 175 million released as cash and cash equivalents.

Business highlights for the period thereafter

  • Phase 2 trial investigating glepaglutide for the treatment of short bowel syndrome completed. Results are expected by end June 2017.
  • A positive opinion on orphan medicinal product designation, issued by The Committee of Orphan Medicinal Products (COMP) for treatment of congenital hyperinsulinism (CHI) in the EU was obtained for dasiglucagon.
  • Zealand and Boehringer Ingelheim GmbH disclosed amylin as the biological target in one of their joint programs, with potential to treat obesity. Start of clinical testing is expected in 2017.
  • Suliqua® launch in the Netherlands occurred in May 2017.

Britt Meelby Jensen, President and CEO of Zealand, commented on the quarter:
"The first quarter of 2017 saw a good start to an important year for Zealand, with financial results as expected. A major milestone was the U.S. launch of Soliqua®100/33 by Sanofi, followed this month by the first launch in the EU. Sanofi has already secured coverage for 34% of commercially insured patients. With Soliqua® 100/33 as the first marketed GLP-1/insulin combination in the U.S., Sanofi continues to educate physicians and expand insurance coverage".

"In addition, we report strong progress on our clinical programs. We look forward to Phase 2 results for glepaglutide, our long-acting GLP-2 analogue for short bowel syndrome, by the end of June, and we plan to report dasiglucagon Phase 2a results this quarter, supporting its potential use in a dual-chamber pump. We are excited to expand our dasiglucagon franchise to include orphan indications, following a positive opinion in the EU for dasiglucagon for the treatment of congenital hyperinsulinism".

"Finally, I would like to highlight the announcement of amylin as the biological target in one of our partnership programs with Boehringer Ingelheim addressing obesity, and we look forward to the advancement into clinical testing later in 2017."

Conference call today at 4 p.m. CET
Zealand's management will be hosting a conference call today at 4 p.m. CET to present the Q1 results. Participating in the call will be President and Chief Executive Officer Britt Meelby Jensen, Executive Vice President and Chief Financial Officer Mats Blom and Executive Vice President and Chief Medical and Development Officer Adam Steensberg. The presentation will be followed by a Q&A session.

The conference call will be conducted in English, and the dial-in numbers are:

DK standard access +45 38322869
U.K. and international +44 (0) 20 3427 1901
U.S. (free dial-in) +1 212 444 0896
Passcode 7623825

A live audio webcast of the call, including an accompanying slide presentation, will be available via the following link, http://edge.media-server.com/m/p/iuasout3, also accessible on the Investor section of Zealand's website (www.zealandpharma.com). Participants are advised to register for the webcast approximately 10 minutes before the start.

A recording of the event will be made available on the Investor section of Zealand's website after the call.

For further information, please contact:

Britt Meelby Jensen, President and Chief Executive Officer
Tel.: +45 51 67 61 28, e-mail: bmj@zealandpharma.com

Mats Blom, Senior Vice President, Chief Financial Officer
Tel.: +45 31 53 79 73, e-mail: mabl@zealandpharma.com

About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq Copenhagen: ZEAL) ("Zealand") is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines. Zealand has a portfolio of medicines and product candidates under license collaborations with Sanofi, Boehringer Ingelheim and Helsinn, and a pipeline of product candidates focusing on specialty gastrointestinal and metabolic diseases.
Zealand's first invented medicine, lixisenatide, a once-daily prandial GLP-1 receptor agonist for the treatment of type 2 diabetes, is licensed to Sanofi. Lixisenatide is marketed as Adlyxin® in the U.S. and as Lyxumia® in the rest of the world. Lixisenatide has been developed in a combination with basal insulin glargine (Lantus®) and is marketed as Soliqua®100/33 in the U.S. and has been approved as Suliqua® in Europe and launched in the Netherlands.

Zealand's clinical pipeline includes: dasiglucagon* (ZP4207, single-dose rescue treatment) for acute, severe hypoglycemia (Phase 2); glepaglutide* (ZP1848) for short bowel syndrome (Phase 2); dasiglucagon* (ZP4207, multiple-dose version) intended for use in a dual-hormone artificial pancreas system for improved hypoglycemia control and diabetes management (Phase 2) and other earlier-stage clinical and preclinical peptide therapeutics.

Zealand is based in Copenhagen (Glostrup), Denmark. For further information about the Company's business and activities, please visit www.zealandpharma.com or follow Zealand on Twitter @ZealandPharma.

* Dasiglucagon and glepaglutide are proposed International Nonproprietary Names (pINN).

Source: Zealand Pharma A/S