Zealand Pharma: Interim report for the first nine months of 2017

Company announcement - No. 50/2017

Interim report for the first nine months of 2017

Copenhagen, November 8, 2017 - Zealand Pharma A/S ("ZEAL") announces financial results and continued strong progress for its product candidates and business for the first nine months of 2017. Financial guidance for 2017 has been revised with 4-6% lower operating expenses.

Financial results for the first nine months of 2017

• Revenue of DKK 128.5 million/USD 20.4 million[1] (DKK 54.3 million/USD 8.1 million2 in the first nine months of 2016).
• Net operating expenses³ of DKK 251.7 million/USD 39.9 million¹ (DKK 220.9 million/USD 33.1 million² in the first nine months of 2016).
• Net result of DKK -162.3 million/USD -25.7 million¹ (DKK -206.7 million/USD -31.0 million² in the first nine months of 2016).
• Cash position of DKK 780.6 million/USD 123.8 million¹ per September 30, 2017 (December 31, 2016: DKK 642.1 million/USD 91.0 million4, including restricted cash).

Business highlights for Q3 2017

• Listing on the Nasdaq Global Select Market in the U.S. raising gross DKK 567 million/USD 90 million[1].
• Initiation of Phase 3 trial with dasiglucagon for the treatment of severe hypoglycemia.
• Orphan drug designation for dasiglucagon for the treatment of congenital hyperinsulinism was granted by FDA in the U.S.
• Boehringer Ingelheim initiated Phase 1 trial in the amylin analog program, triggering a EUR 4 million milestone payment to Zealand.
• Boehringer Ingelheim initiated Phase 1 trial in the GLP-1/glucagon dual agonist program.
• Soliqua^® 100/33 revenue increased 37% and payer coverage increased 4%-point over the previous quarter to cover 65% of commercial lives.

Business highlights for the period thereafter

• Orphan drug designation for glepaglutide for the treatment of short bowel syndrome granted by FDA in the U.S.
• The potential for less than once-daily dosing with glepaglutide is being evaluated in a clinical trial, following positive results in the Phase 2 trial for Short Bowel Syndrome.
• Patient enrolment completed for Phase 3 trial with dasiglucagon for the treatment of severe hypoglycemia.

Britt Meelby Jensen, President and CEO of Zealand, comments:
"We continue to see strong results and progress with our clinical product candidates, and following the U.S. IPO in August, where we raised USD 90 million, we are in a solid position to advance our late stage clinical programs at full speed. For glepaglutide, we are in preparation to start Phase 3 mid-2018, we received orphan drug designation and we are finalizing a trial to assess the potential for a better dosing option for patients. In addition, two of our partnered programs have advanced to Phase 1 for treatment of obesity and/or diabetes. With this, I am convinced that Zealand is set for a successful future."

Revised financial guidance for 2017 
For 2017, Zealand maintains its revenue guidance of a continued increase in royalty payments from Sanofi. No specific guidance on the level of royalties can be provided as Sanofi has not provided any guidance on expected 2017 sales.

Milestone revenue of DKK 101 million has been received from partners.

Net operating expenses in 2017 are expected to be within the range of DKK 375-385 million, 4-6 % lower than previously guided (DKK 390-410 million). The decrease relates to timing of clinical studies as well as tight cost control.

Operating loss before royalty income/expenses has been reduced from DKK 290-310 million to DKK 275-285 million.

Conference call today at 4 pm CET/10 am EST
Zealand's management will be hosting a conference call today at 4 pm CET/10 am EST to present the results for the first nine months of 2017. 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 dial-in numbers are:

DK standard access             +45 32711658
UK and international            +44 (0) 20 3427 1907
U.S. (free dial-in)                 +1 646 254 3366
Passcode                            3321181

A live audio webcast of the call, including an accompanying slide presentation, will be available via the following link, https://edge.media-server.com/m6/p/wr84wf2d 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, Executive Vice President and Chief Financial Officer
Tel.: +45 31 53 79 73, e-mail: mabl@zealandpharma.com

[1] Translated solely for convenience into U.S. dollars at an assumed exchange rate of DKK 6.30 per USD 1.00, which was the rounded official exchange rate of such currencies at September 30, 2017.
2 Translated solely for convenience into U.S. dollars at an assumed exchange rate of DKK 6.68 per USD 1.00, which was the rounded official exchange rate of such currencies at September 30, 2016.
3 Net operating expenses consist of research, development and administrative expenses less other operating income.
4 Translated solely for convenience into U.S. dollars at an assumed exchange rate of DKK 7.05 per USD 1.00, which was the rounded official exchange rate of such currencies at December 31, 2016.

Attachments:

http://www.globenewswire.com/NewsRoom/AttachmentNg/c335bc3e-baed-4c37-a6b9-4a9afa57572a