Company announcement – No. 7 / 2022
Full Year Results for 2021
In 2021, a number of significant milestones were accomplished by
Financial results for the full year 2021
- Revenue of
DKK 292.6 million /USD 44.6 million (2020:DKK 353.3 million /USD 54.2 million ). - Net operating expenses of
DKK 1,224.7 million /USD 186.7 million (2020:DKK 1,092.1 million /USD 166.9 million ). - Operating result for the year of
DKK -1,052.4 million /USD -160.4 million (2020:DKK -792.4 million /USD -121.4 million ). - Cash including marketable securities amounted to
DKK 1,428.1 million /USD 217.7 million at year-end (2020:DKK 1,257.6 million /USD 192.2 million ).
Business highlights and updates for Q4 2021 and the period thereafter
- Completion of patient enrollment in the second Phase 3 Trial (17103) of dasiglucagon for the treatment of Congenital hyperinsulinism (CHI) in neonates up to 12 months old. Top-line results are expected in the second quarter of 2022. This Phase 3 study is the last in the program which constitute the largest clinical development program ever conducted in CHI.
- Completion of patient enrollment in the pivotal Phase 3 trial (EASE-SBS 1) of glepaglutide. Full results of the EASE-SBS 1 pivotal Phase 3 trial are expected in the third quarter of 2022.
- Signed seven-year,
$200 million financing agreement withOberland Capital . The agreement includes an upfront payment of$100 million in exchange for a seven-year, interest-only secured note. The non-dilutive debt facility will support continued development of the clinical pipeline, including additional indications for dasiglucagon and glepaglutide, as well as the Company’s earlier stage pipeline investigating unmet needs in obesity and inflammatory diseases. - Presentation of first clinical data for long-acting GCGR/GLP1dual agonist, BI 456906, for the treatment of obesity and associated metabolic diseases. The data showed up to 13.7% weight loss following 16 weeks of administration with BI 456906 in the Phase 1b trial. The Phase 2 trial of BI 456906 in type 2 diabetes has been completed and Zealand has achieved full randomization the Phase 2 trial of the compound in obesity.
- First subject dosed in Phase 1 trial of amylin analogue ZP8396 for the treatment of obesity. The Phase 1, first-in-human, randomized, single ascending dose trial, will assess the safety, tolerability, pharmacokinetics, and pharmacodynamics of ZP8396 administered to healthy subjects. Preclinical data have shown potent anti-obesity effects of ZP8396 both as a monotherapy and in combination with a GLP1 analogue.
- Announced successful outcome of Phase 1b clinical trial for dapiglutide The GLP1-GLP2 dual receptor agonist was assessed to be safe and well tolerated following 4 weeks of dosing in humans and effects on several biomarkers suggest that clinically relevant exposures of dapiglutide were achieved in the study. Zealand will be exploring several potential indications in gastrointestinal and metabolic diseases.
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“2021 was a transformational year for
Financial guidance
In 2022,
In 2022, Zealand Pharma expects revenue from existing license agreements. However, since such revenue is uncertain in terms of size and timing, Zealand Pharma does not intend to provide guidance on such revenue.
Net operating expenses in 2022 are expected to be DKK 1,200.0 million +/-10% compared to 2021 of DKK 1,224.7 million.
Update regarding COVID-19
Commercial Update
Zegalogue® (dasiglucagon) injection
Zegalogue launched in the
Zegalogue net revenue for FY 2021 was
V-Go® wearable insulin delivery device
The V-Go series of Wearable Insulin Delivery Devices are indicated for continuous subcutaneous infusion of either 20 Units of insulin (0.83 U/hr), 30 Units of insulin (1.25 U/hr) or 40 Units of insulin (1.67 U/hr) in one 24-hour time period and on-demand bolus dosing in 2-Unit increments (up to 36 Units per one 24-hour time period) in adults requiring insulin.
V-Go net revenue for the FY 2021 was
Pipeline Update
Dasiglucagon for Bihormonal Artificial Pancreas systems
Zealand is collaborating with Beta Bionics, developer of the Bihormonal iLet® bionic pancreas system, a pocket-sized, dual chamber (insulin and glucagon), autonomous, glycemic control system. The iLet® bionic pancreas is an investigational device, limited by federal (or
Zealand’s partner, Beta Bionics, and the study sponsor, the
The primary outcome measure in the RCTs is superiority in HbA1c of the bihormonal iLet® bionic pancreas using dasiglucagon relative to the insulin-only iLet® system after 26 weeks of therapy on the two interventions. The bihormonal iLet® bionic pancreas performance will also be compared to intensified usual care using CGM therapy in a third arm in both the pediatric and adult RCTs.
Dasiglucagon mini-dose pen
Zealand is developing a dasiglucagon mini-dose pen for potential treatment of exercise-induced hypoglycemia in people living with type 1 diabetes and for people who suffer from meal-induced hypoglycemia following gastric bypass surgery.
Clinical studies conducted in hospital settings have shown the potential for using low doses of dasiglucagon to correct moderate hypoglycemia. Top-line results from a Phase 2a dose-finding trial in people with type 1 diabetes were presented at the
In 2022, Zealand expect to present data from out-patient Phase 2 trials, utilizing the dasiglucagon mini-dose pen in in people with type 1 diabetes and for people that suffer from meal-induced hypoglycemia following gastric bypass surgery (ClinicalTrials.gov Identifier: NCT04764968 and NCT04836273).
Dasiglucagon for congenital hyperinsulinism (CHI)
The potential for chronic dasiglucagon infusion delivered via a pump to prevent hypoglycemia in children with CHI is being evaluated in a Phase 3 program. The aim is to reduce or eliminate the need for intensive hospital treatment, reduce the frequency of dangerous low blood glucose and need for constant feeding, and to potentially delay or eliminate the need for pancreatectomy. The FDA and the
Data from the first Phase 3 trial in the program, trial 17109, were reported in
We have completed enrollment into the second Phase 3 trial, 17103, in neonates up to 12 months old with CHI Trial results are expected in Q2 2022 and if positive we expect to submit an NDA with the
Glepaglutide for short bowel syndrome (SBS)
Glepaglutide is a long-acting GLP-2 analog, being investigated for the potential treatment of short bowel syndrome with the primary endpoint of reducing or eliminating the need for parenteral support in people living with SBS, as further detailed below. Phase 2 data have shown the potential of glepaglutide to increase intestinal absorption in people with SBS.
The EASE-SBS Phase 3 program includes 4 trials. EASE-SBS 1 is the pivotal Phase 3 trial with enrolment of up to 108 patients with SBS that seeks to establish the efficacy and safety of once- and twice-weekly administration of glepaglutide. The initial trial duration is six months, whereafter trial participants are able to enroll in the extension trials, EASE-SBS 2 and 3. A Phase 3b trial, EASE-SBS 4, was initiated in Q3 2021 and will assess long-term effects of glepaglutide on intestinal fluid and energy uptake.
Enrollment has been completed in the EASE-SBS 1 trial and we expect to have results in Q3 2022. The primary endpoint in the trial is the absolute reduction in parenteral support and in the event of positive trial results we expect to submit an NDA with the FDA based on efficacy and safety data from the full EASE-SBS trial program. The FDA granted orphan drug designation to glepaglutide for the treatment of SBS.
Dapiglutide
Dapiglutide (pINN) is a long-acting GLP-1R/GLP-2R dual agonist. The Phase 1b multiple-ascending dose, safety and tolerability trial investigating dapiglutide in healthy volunteers was completed in
ZP8396
ZP8396 is a potent long-acting amylin analogue designed to improve solubility and allow for co-formulation with other peptides, including GLP1 analogues. Amylin analogues hold potential as both mono and combination therapies for obesity and type 2 diabetes. Preclinical data on ZP8396 was presented at
The Phase 1a clinical trial with ZP8396 for potential treatment of obesity was initiated in
BI 456906 for obesity, diabetes and non-alcoholic steatohepatitis (with
The dual glucagon (GCGR)/GLP1 receptor agonist, BI 456906, activates two key gut hormone receptors simultaneously and may offer better efficacy than current single-hormone receptor agonist treatments. The lead molecule BI 456906 is targeting treatment of obesity and associated metabolic diseases. At Obesity Week in
The molecule is being assessed across three parallel Phase 2 trials. The Phase 2 trial in people with diabetes is completed and we are planning to present data from the trial at scientific conferences later in 2022. The trial evaluated dose-relationship of BI 456906 on HbA1c from baseline to 16 weeks relative to placebo in 410 people with diabetes (ClinicalTrials.gov Identifier: NCT04153929). Secondary objectives were to assess the effect on change in body weight. The second Phase 2 randomized double-blind placebo-controlled dose-finding trial evaluating BI 456906 in people with overweight/obesity has reached its randomization target (ClinicalTrials.gov Identifier: NCT04667377). We expect trial results later this year with the primary endpoint being the percentage change in body weight at week 46 compared to placebo. The third Phase 2 randomized double-blind placebo-controlled dose-finding trial is evaluating BI 456906 in people with NASH and liver fibrosis (F2/F3) (ClinicalTrials.gov Identifier: NCT04771273). The primary endpoint of this trial is the histological improvement of steatohepatitis without worsening of fibrosis after 48 weeks of treatment. Participants will receive a weekly subcutaneous injection of either different doses of BI 456906 or placebo for the duration of the trial. The NASH program has received Fast Track Designation from the
Complement inhibitors (with Alexion, AstraZeneca Rare Disease)
For the lead target,
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Zealand Pharma’s Annual Report 2021
This announcement is a summary and is qualified by, and should be read in conjunction with, Zealand’s Annual Report for 2021, published on
Conference call March 10, 2022, at 4:00 PM CET (10:00 AM EDT)
Zealand’s management will host a conference call on
The conference call will be conducted in English, and the dial-in numbers are:
Confirmation Code: .......................9554999
A live audio webcast of the call, including an accompanying slide presentation, will be available via the following link, https://edge.media-server.com/mmc/p/7daetm5k, also accessible from 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 available on the Investor section of Zealand’s website following the call.
For further information, please contact:
Zealand Pharma Investor Relations |
investors@zealandpharma.com |
Zealand Pharma Media Relations |
media@zealandpharma.com |
NOTE: Exchange rates used:
About
Zealand was founded in 1998 in
Forward-Looking Statements
This announcement may contain forward-looking statements, including “forward-looking” statements within the meaning of the Private Securities Litigation Reform Act of 1995, that are based on the beliefs and assumptions and on information currently available to management of Zealand, including with respect to the company’s anticipated revenue and expenses for 2021 and potential product approval by the FDA. All statements other than statements of historical fact contained in this announcement are forward-looking statements, including statements regarding the anticipated final terms of the Investment. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negative of these terms or other comparable terminology. Forward-looking statements involve known and unknown risks, uncertainties and other factors that may cause Zealand's actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. These risks and uncertainties include, but are not limited to, the risks and uncertainties set forth in the "Risk Factors" section of the Zealand's Annual Report on Form 20-F for the year ended
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