6-K

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 6-K

REPORT OF FOREIGN PRIVATE ISSUER

PURSUANT TO RULE 13a-16 OR 15d-16

UNDER THE SECURITIES EXCHANGE ACT OF 1934

September 19, 2018

Commission File Number: 001 - 38178

Zealand Pharma A/S

(Exact Name of Registrant as Specified in Its Charter)

Smedeland 36
2600 Glostrup (Copenhagen)
Denmark

(Address of principal executive offices)

Indicate by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F.

Form 20-F x            Form 40-F o

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1):  o

Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7):  o

Furnished as Exhibit 99.1 to this Report on Form 6-K is a press release of Zealand Pharma A/S or the Company, dated September 18, 2018, announcing that Zealand Pharma achieves primary and key secondary endpoints in pivotal Phase 3 trial with dasiglucagon for severe hypoglycemia.

Furnished as Exhibit 99.2 to this Report on Form 6-K is the Company’s slide presentation on the results of the pivotal Phase 3 trial with dasiglucagon for severe hypoglycemia.

SIGNATURE

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned, thereunto duly authorized.

Zealand Pharma A/S
By:	/s/ Mats Blom
	Name:	Mats Blom
	Title:	Chief Financial Officer

Date: September 19, 2018

2

EXHIBIT INDEX

Exhibit No.	Description
99.1	Press release dated September 18, 2018
99.2	Slide Presentation on dasiglucagon rescue pen pivotal Phase 3 results

3

EX-99.1

Exhibit 99.1

Company announcement — No. 23/2018

Zealand Pharma achieves primary and key secondary endpoints in pivotal Phase 3 trial with dasiglucagon for severe hypoglycemia

·All primary and key secondary endpoints successfully achieved

·99% of patients on dasiglucagon recovered from low blood glucose within 15 minutes

·Median time to plasma glucose recovery of 10 minutes with dasiglucagon

·Conference call today, September 18 at 5 PM CET/11 AM ET

Copenhagen, September 18, 2018 — Zealand Pharma A/S (“Zealand”) (Nasdaq: ZEAL), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, announces the successful results in the pivotal Phase 3 trial with dasiglucagon for severe hypoglycemia in diabetes.

Dasiglucagon is a potential first-in-class soluble glucagon analog invented and developed by Zealand. It is in development in the ready-to-use HypoPal® rescue pen for easy, fast and effective treatment of severe hypoglycemia.

The pivotal Phase 3 trial demonstrates that a single dose of dasiglucagon rapidly increases blood glucose levels in patients with type 1 diabetes following insulin-induced hypoglycemia. The trial compares the glycemic response observed after administration of dasiglucagon with that of placebo and that of currently marketed glucagon, in powder form for reconstitution prior to injection. The primary endpoint was time to plasma glucose recovery, which was defined as first increase in plasma glucose of >20 mg/dL (1.1 mmol/L) from baseline without administration of rescue intravenous glucose. 168 subjects were included in the trial: 82 to the dasiglucagon arm, 43 to the placebo arm, and 43 to the GlucaGen® arm. Additional details about the trial are found at https://clinicaltrials.gov/ct2/show/NCT03378635.

·The primary result demonstrates that the median time to blood glucose recovery was 10 min for dasiglucagon, which was superior to placebo (median: 40 min; p<0.001). The median time to recovery for GlucaGen® was 12 min.

·99% of subjects were recovered from the insulin-induced hypoglycemia within 15 min following dosing with dasiglucagon, versus 2% with placebo and 95% with GlucaGen®.

Overall, no safety concerns were raised for dasiglucagon within the trial. Nausea and vomiting were reported with similar numbers for dasiglucagon and GlucaGen® (nausea: 55% and 53%, vomiting: 23% and 19%, respectively).

Adam Steensberg, Executive Vice President and Chief Medical and Development Officer at Zealand Pharma, commented: “I believe that the Phase 3 results are outstanding, and show that dasiglucagon HypoPal® rescue pen could become the fastest rescue treatment for severe hypoglycemia. I am grateful to the patients and clinical investigators who participated in the trial.”

Professor, Dr. Thomas R. Pieber, Medical University of Graz, Department of Internal Medicine, Division of Endocrinology and Diabetology, said: “The results of this Phase 3 trial are impressive in that all patients had clinical relevant increases in blood glucose level within 15 minutes, with a median time to recovery of only 10 minutes. The rapid onset of action suggests that dasiglucagon could become a very attractive treatment option for diabetes patients having a severe hypoglycemic event.”

This is the second Phase 3 trial with positive results for dasiglucagon. The previous Phase 3 trial confirmed dasiglucagon’s safety profile. Zealand will soon initiate a Phase 3 trial in pediatric diabetes patients, which is expected to complete in mid-2019.

Britt Meelby, President and Chief Executive Officer at Zealand Pharma, commented: “The compelling Phase 3 results bring the dasiglucagon HypoPal® rescue pen a significant step closer to a better treatment for people living with diabetes, addressing one of their biggest fears. I am thrilled about this achievement, which represents an important milestone for Zealand in executing our strategy of bringing fully-owned products through registration.”

Conference call today, September 18 at 5 PM CET/11 AM ET

Zealand’s management will host a conference call today, September 18, at 5:00 PM CET/11:00 AM ET to discuss the results of this pivotal phase 3 trial. 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 & 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:

Denmark:	+45 35 15 80 49
United Kingdom:	+44 (0)330 336 9128
United States:	+1 929-477-0448
Passcode	4510337

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/khb3xico, and will be 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 scheduled start.

A recording of the event and a transcript will be 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, Chief Financial Officer

Tel.: +45 31 53 79 73, e-mail: mabl@zealandpharma.com

Dasiglucagon (glucagon analog stable in liquid formulation) for use in other indications

Dasiglucagon is a Zealand-invented glucagon analog with a unique stability profile in a ready-to-use aqueous solution. It is also in development for two additional indications: treatment of type 1 diabetes with a next-generation artificial pancreas, and treatment for children born with a genetic mutation that causes congenital hyperinsulinism (CHI).

About type 1 diabetes and hypoglycemia

People with type 1 diabetes suffer from insulin deficiency and inappropriate glucagon secretion. Both hormones are essential to ensure stable and healthy blood glucose levels. Consequently, patients must monitor and adjust their blood glucose levels to remain in proper glycemic control, as both high and low blood glucose may affect their health, both in the short and long term.

Severe hypoglycemia is an acute, life-threatening condition resulting from a critical drop in blood glucose levels associated primarily with insulin therapy. Severe hypoglycemia occurs most frequently in people with type 1 diabetes due to injecting insulin multiple times daily. It is the biggest concern for insulin-dependent patients and the most feared complication of diabetes treatment. The condition is characterized by confusion, seizures, and often loss of consciousness that can result in death if left untreated.

When a patient has a hypoglycemic event, a second person must assist in treatment. Currently marketed formulations of glucagon for the treatment of severe hypoglycemia require mixing first by the person assisting to treat and then immediate administration due to poor drug stability. Dasiglucagon is being developed to offer a stable ready-to-use rescue treatment for severe hypoglycemia.

About Zealand Pharma A/S

Zealand Pharma A/S (Nasdaq Copenhagen and New York: ZEAL) (“Zealand”) is a biotechnology company focused on the discovery and development of innovative peptide-based medicines. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand’s current pipeline of internal product candidates focus on specialty gastrointestinal and metabolic diseases. Zealand’s portfolio also includes two clinical license collaborations with Boehringer Ingelheim.

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 LinkedIn or Twitter @ZealandPharma.

EX-99.2

Exhibit 99.2

Dasiglucagon Phase 3 results Conference call 18 September 2018

Forward-looking statements This presentation contains information pertaining to Zealand Pharma A/S (“Zealand"). Neither Zealand nor its management, directors, employees or representatives make any representation or warranty, express or implied, as to the accuracy or completeness of any of the information contained in this presentation or any other information transmitted or made available to the viewer or recipient hereof, whether communicated in written or oral form. This presentation does not constitute or form part of, and should not be construed as, an offer to sell or issue or the solicitation of an offer to buy or acquire Zealand securities, in any jurisdiction, or an inducement to enter into investment activity, nor shall there be any sale of Zealand securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction. No part of this presentation, nor the fact of its distribution, should form the basis of, or be relied on in connection with, any contract or commitment or investment decision whatsoever. This presentation contains forward-looking statements that reflect management's current views with respect to Zealand's product candidates' development, clinical and regulatory timelines and anticipated results, market opportunity, potential financial performance and other statements of future events or conditions. Although Zealand believes that the expectations reflected in such forward-looking statements are reasonable, no assurance can be given that such expectations will prove to have been correct. Accordingly, results could differ materially from those set out in the forward-looking statements as a result of various factors, many of which are beyond Zealand’s control. No reliance should be made on such forward-looking statements. Zealand does not intend to update the presentation, including the forward-looking statements contained therein, following distribution, beyond what is required by applicable law or applicable stock exchange regulations if and when circumstances arise that lead to changes compared to the date when these statements were provided.

All primary and key secondary endpoints successfully achieved 99% of patients on dasiglucagon recovered from low blood glucose within 15 minutes Median time to plasma glucose recovery of 10 minutes with dasiglucagon Primary and key secondary endpoints achieved in pivotal Phase 3 trial with dasiglucagon for severe hypoglycemia For illustration only

Severe hypoglycemia is one of the most feared complications for diabetes patients on insulin therapy 1 IDF Diabetes Atlas 8th Edition 2017; 2 American Diabetes Association; 3 cdc.gov and diabetes.org 4 www.diabetesselfmanagement.com/diabetes-resources/tools-tech/insulin-pumps; 5 Kalra 2013, UK Hypoglycemia Study Group; 6 International Hypoglycemia Study Group. Diabetes Care. 2015;38:1583–1591; 7 National Diabetes Statistics Report. CDC. 2014. One of the most feared complications for insulin-treated patients5 Happens to up to 40% of type 1 diabetes patients every year6 ~300,000 hospitalizations per year in the U.S.7 Large burden of severe hypoglycemia Diabetes patients on insulin treatment In the U.S. alone 22-23m people are diagnosed2 with diabetes 1.25m type 1 diabetes patients are insulin-treated3 4-5m type 2 diabetes patients are insulin-treated3,4 Globally, ~425 million adults has diabetes, a number expected to grow to ~629 million by 20451

The glucagon rescue market has substantial value potential 1 Estimate based on IMS Health data, 2017 volume of glucagon rescue kit market; 2 IMS Health data, 2017 value, including value from vials used for diagnostic use; 3 2016 U.S. volume (IMS Health) forecasted with an increase in T1D prevalence of 3% per year (JDRF) and increased adoption of rescue treatments with new options available; 4 Based on estimated annual price increase of 5; 5 Rest of World include China, Japan and Canada 2018E 2025E ~2,0 1,0 ~2.51 ~2,0 ~6,03 ~2,0 0,5 0,9 ~2,5 2030E ~3,0 ~4,0 +9.03 U.S. EU Top5 RoW5 The global market for rescue treatments is expected to grow significantly In the U.S., the market is expected to exceed USD 1.0 billion by 2030 Estimated market volume million rescue treatments +1.0004 2030E 2018E 2025E 3502 +7004 Estimated U.S. market value USD million Increased awareness Increased penetration Improved ease of use3

ZP4207-16137 Confirmatory Phase 3 trial A phase 3, Randomized, Double-Blind, Parallel Trial to Confirm the Clinical Efficacy and Safety of Dasiglucagon in the Rescue Treatment of Hypoglycemia in Subjects with Type 1 Diabetes Mellitus (T1DM) Compared to Placebo and with Reference to GlucaGen® Key Inclusion Criteria: Male or female patients with T1DM treated with insulin for at least 1 year, diagnostic criteria as defined by the American Diabetes Association Stable insulin treatment 30 days prior to screening, defined as no more than a 10-unit daily variation in total daily insulin dose Hemoglobin A1c (HbA1c) <10% Aged between 18 and 70 years, both inclusive

Trial design Randomization Hypoglycemic clamp procedure Administration of trial drug 5-hour sampling Randomized, parallel-group, double-blind, phase 3 trial 2:1:1 randomization to a sc single-dose of Dasiglucagon 0.6 mg (n=82) Placebo (n=43) GlucaGen 1 mg (n=43)

Trial endpoints Primary Time to plasma glucose recovery Plasma glucose recovery is defined as first increase in plasma glucose of > 20 mg/dL from baseline without administration of rescue IV glucose (censoring at rescue or at 45 min) Key secondary 1-4: Plasma glucose recovery within 30 minutes, within 20 minutes, within 15 minutes, and within 10 minutes after trial drug injection without administration of rescue IV glucose 5-8: Plasma glucose changes from baseline to 30 minutes, to 20 minutes, to 15 minutes, and to 10 minutes after trial drug injection or at the time of rescue

Median time to glucose recovery with dasiglucagon was 10 minutes with 99% of patients having recovered within 15 minutes Minutes to plasma glucose recovery Dasiglucagon 82 subj Placebo 43 subj GlucaGen® 43 subj Median (95% CI distribution-free) 10 (10, 10) 40 (30, 40) 12 (10, 12) Log-rank test vs placebo p<0.001 Plasma glucose increase of 20 mg/dL Dasiglucagon 82 subj Placebo 43 subj GlucaGen® 43 subj Within 15 minutes 99% 2% 95% Fisher’s exact test p<0.001

Overall, no safety concerns were raised for dasiglucagon within the trial Nausea, vomiting and headache were reported with similar numbers for dasiglucagon and GlucaGen® Dasiglucagon 82 subj Placebo 43 subj GlucaGen® 43 subj Subjects Events Subjects Events Subjects Events Nausea 45 (55%) 46 1 (2%) 1 23 (53%) 24 Vomiting 19 (23%) 25 1 (2%) 1 8 (19%) 10 Headache 10 (12%) 10 2 (5%) 2 5 (12%) 5

Well-conducted trial with high quality data Met primary endpoint; time to plasma glucose recovery was faster for dasiglucagon than placebo (p<0.001) Median time to plasma glucose recovery: Dasiglucagon 10 min, Placebo 40 min, Glucagen® 12 min 15 min recovery rate: Dasiglucagon 99%, Placebo 2% , Glucagen® 95% Safe and well-tolerated with predictable class effects Conclusions from the pivotal Phase 3 trial

Competitive landscape for treatment of severe hypoglycemia For illustration only Glucagon Emergency kit (Eli Lilly)1 Zealand has developed dasiglucagon: a novel stable glucagon analog Fast onset of action Ready-to-use auto-injector pen, no need for reconstitution Stability at refrigerated temperature (5oC / 41oF) and room temperature (25oC / 77oF) 1 The Glucagon Emergency kit design is a trademark of Eli Lily and Company G-Pen subcutaneous auto-injector (Xeris) Locemia intranasal spray (Lilly) Marketed products Late-stage development

Novel glucagon analog Unique stability in liquid formulation Fast onset-of-action The unique profile of dasiglucagon creates opportunities to target a number of diseases with high unmet need Dasiglucagon Pump treatment for recurrent low blood glucose, Congenital hyperinsulinism (CHI) – Phase 3 ready Rare disease Automated diabetes care with a dual hormone pump – Phase 2b ready HypoPal® rescue pen for severe hypoglycemia – Phase 3 ongoing Diabetes care

Dasiglucagon Rare disease Congenital hyperinsulinism Phase 3 initiation Dasiglucagon HypoPal® rescue pen Acute, severe hypoglycemia Phase 3 pediatric trial initiation Dasiglucagon dual-hormone pump Diabetes management Phase 2b initiation Realizing value in the Zealand pipeline Dasiglucagon achieved primary and secondary endpoints in pivotal phase 3 trial Upcoming milestones for dasiglucagon in 2018 Met primary endpoint; time to plasma glucose recovery was faster for dasiglucagon than placebo (p<0.001) Median time to plasma glucose recovery: Dasiglucagon 10 min, Placebo 40 min, Glucagen® 12 min 15 min recovery rate: Dasiglucagon 99%, Placebo 2%, Glucagen® 95% Safe and well-tolerated with predictable class effects

Q&A