Company announcement - No. 40 /2017
Interim report for the first half of 2017
Copenhagen, August 24, 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 first half of 2017.
Financial results for the first half of 2017
- Revenue of DKK 88.4 million/USD 13.6 million (DKK 14.7 million/USD 2.2 million2 in first half of 2016).
- Net operating expenses3 of DKK 174.8 million/USD 23.3 million1 (DKK 165.4 million/USD 20.9 million2 in first half of 2016).
- Net result of DKK -120.0 million/USD -18.4 million1 (DKK -175.7 million/USD -26.2 million2 in first half of 2016).
- The cash position amounted to DKK 308.3 million/USD 47.3 million1 at June 30, 2017 (December 31, 2016: DKK 642.1 million/USD 91.0 million4, including restricted cash).
Business highlights for Q2 2017
- Glepaglutide met the primary endpoint in a Phase 2 clinical trial in short bowel syndrome patients.
- Positive results reported from two Phase 2a trials with dasiglucagon, supporting use in a dual-chamber hormone pump system.
- Orphan designation for dasiglucagon obtained in the EU for the treatment of congenital hyperinsulinism (CHI).
- Helsinn returned elsiglutide and all rights to develop products within cancer-supportive care.
Business highlights for the period thereafter
- First patients dosed in a Phase 3 trial evaluating dasiglucagon for the treatment of severe hypoglycemia in diabetes.
- Orphan designation for dasiglucagon obtained in the U.S. for the treatment of congenital hyperinsulinism (CHI).
- First patients dosed in a Phase 1 trial in the amylin analog program partnered with Boehringer Ingelheim.
- First patients dosed in a Phase 1 trial in the GLP-1/glucagon dual agonist program partnered with Boehringer Ingelheim.
- Soliqua® 100/33 reached 62% commercial access at July 1, 2017.
- Capital increase of DKK 566 million/USD 90 million (gross proceeds) through a Nasdaq Global Select Market listing in the U.S.
Britt Meelby Jensen, President and CEO of Zealand, comments on the first half of 2017:
"It has been an important and eventful second quarter of 2017 for Zealand, with significant progress in our clinical programs. We reported strong Phase 2 results with our long-acting GLP-2 analog for short bowel syndrome, glepaglutide, as well as positive results from two Phase 2a trials for dasiglucagon, supporting its potential use in a dual-chamber pump and for the treatment of type 1 diabetes. In early July, we initiated Phase 3 with dasiglucagon as a rescue treatment for insulin shock. These are all products that are fully owned by Zealand and, based on the strong results, support continued development. We also raised DKK 566 million, or USD 90 million, in gross proceeds through a listing on Nasdaq in the U.S."
Financial guidance for 2017 unchanged
Zealand maintains its financial guidance for 2017 as announced in the financial release for the full year 2016 (issued on March 15, 2017). For 2017, Zealand expects 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.
Additional revenue of DKK 100 million is expected from event-driven partner-related milestones, of which DKK 70 million was received in January 2017.
Net operating expenses in 2017 are expected to be within the DKK 390-410 million range. The increase compared with 2016 is explained primarily by higher clinical development costs associated with the advancement of glepaglutide and dasiglucagon.
Operating loss before royalty income/expenses is expected to be within the range of DKK 290-310 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 to present the results for the first half 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 conference call will be conducted in English, and the dial-in numbers are:
DK standard access +45 32711658
UK and international +44 (0) 20 3427 1900
U.S. (free dial-in) +1 212 444 0481
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/hw2t5jmw, 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: firstname.lastname@example.org
Mats Blom, Executive Vice President and Chief Financial Officer
Tel.: +45 31 53 79 73, e-mail: email@example.com
About Zealand Pharma A/S
Zealand (Nasdaq Copenhagen and New York: ZEAL) is a biotechnology company focused on the discovery, design and development of innovative peptide-based medicines.
Zealand is based in Copenhagen (Glostrup), Denmark.
Safe Harbor/Forward-Looking Statements
The above information contains forward-looking statements that provide our expectations or forecasts of future events such as new product introductions, clinical development activities and anticipated results, product approvals and financial performance. Such forward-looking statements are subject to risks, uncertainties and inaccurate assumptions. This may cause actual results to differ materially from expectations and it may cause any or all of our forward-looking statements here or in other publications to be wrong. Factors that may affect future results include interest rate and currency exchange rate fluctuations, delay or failure of clinical trials and other development activities, production problems, unexpected contract breaches or terminations, government-mandated or market-driven price decreases for Zealand's products, introduction of competing products, Zealand's ability to successfully market both new and existing products, exposure to product liability and other lawsuits, changes in reimbursement rules and governmental laws and related interpretation thereof, and unexpected growth in costs and expenses.
Certain assumptions made by Zealand are required by Danish Securities Law for full disclosure of material corporate information. Some assumptions, including assumptions relating to sales associated with a product that is prescribed for unapproved uses, are made taking into account past performances of other similar drugs for similar disease states or past performance of the same drug in other regions where the product is currently marketed. It is important to note that although physicians may, as part of their freedom to practice medicine in the United States, prescribe approved drugs for any use they deem appropriate, including unapproved uses, at Zealand, promotion of unapproved uses is strictly prohibited.
 Translated solely for convenience into U.S. dollars at an assumed exchange rate of DKK 6.52 per USD 1.00, which was the rounded official exchange rate of such currencies at June 30, 2017.
2 Translated solely for convenience into U.S. dollars at an assumed exchange rate of DKK 6.70 per USD 1.00, which was the rounded official exchange rate of such currencies at June 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.
 Dasiglucagon is a proposed International Non-proprietary Name (pINN).
 Glepaglutide is a proposed International Non-proprietary Name (pINN).