Company announcement No. 51 / 2022
Zealand Pharma Announces Financial Results for the First
Nine Months of 2022
Copenhagen, Denmark November 10, 2022 – Zealand
Pharma A/S (Nasdaq: ZEAL) (CVR-no. 20045078) a biotechnology
company focused on the discovery and development of innovative
peptide-based medicines, today announced the interim report for the
three and nine months ended September 30, 2022 and provided a
corporate update.
Key strategic objectives achieved
Adam Steensberg, President and Chief Executive at Zealand Pharma
said: "Zealand has continued to execute and deliver on key
objectives in the third quarter. In September, we completed our
stated objective of securing partnerships for our marketed products
through a license and development agreement with Novo Nordisk, a
global leader in diabetes, to commercialize Zegalogue®.
"Within our R&D pipeline of investigational therapeutic
peptides we have seen further positive clinical data. In September
we reported topline results from the Phase 3 EASE-1 trial showing
that treatment of short bowel syndrome patients with twice weekly
glepaglutide, our long-acting GLP-2 analogue, resulted in a
statistically significant 5.13 liters/week reduction from baseline
in the volume of parenteral support required. Importantly,
approximately 1 in 8 patients treated with glepaglutide weaned off
parenteral support within 24 weeks, while no placebo treated
patients were able to wean off parenteral support, which we believe
is differentiating from current treatments. We look forward to
seeing the results of the ongoing glepaglutide EASE-2 and 3 long
term extension trials and engaging with the regulatory authorities
in preparation for an NDA submission. In obesity, our partner
Boehringer Ingelheim, presented Phase 2 data for the dual
GCGR/GLP-1R agonist BI 456906 in patients with type 2 diabetes,
showing encouraging glycemic control through a reduction in HbA1c,
as well as body weight loss. We are encouraged by these results and
look forward to seeing the results from Boehringer's ongoing Phase
2 trial in patients with obesity, which we expect next year. We
also made progress with our own early-stage clinical candidates in
obesity.
"Finally, we strengthened our balance sheet with gross proceeds
of DKK 786 million from a directed issue and private placement
resulting in an adjusted cash position of DKK 1,515 million in
early October."
Financial results for the first nine
months of 2022
- Revenue: DKK 80.1 million (DKK 95.1 million in
the first nine months of 2021).
- Net operating expenses: DKK -675.7 million
(DKK -652.8 million in the first nine months of 2021).
- Net operating result: DKK -596.2 million (DKK
-568.7 million in the first nine months of 2021).
- Net financial items: DKK -53.4 million (DKK
21.5 million in the first nine months of 2021).
- Net result from Discontinued Operations: DKK -215.1
million (DKK -193.7 million in the first nine months of
2021).
- Cash, cash equivalents, and marketable securities: DKK
729.9 million as of September 30, 2022 (September 30,
2021: DKK 1,049.0 million).
Highlights in the third quarter 2022
- Announced positive topline results from the pivotal
Phase 3 EASE-1 trial of glepaglutide, a long-acting GLP-2 analogue
designed for subcutaneous delivery via auto-injector, in patients
with short bowel syndrome (SBS). Glepaglutide treatment
met the primary endpoint with twice weekly dosing achieving a
statistically significant reduction in weekly parenteral support
volume by 5.13 Liters/week from baseline at 24 weeks. 66% of
patients in the twice weekly group had a clinically meaningful
response (>20% reduction in parenteral support volume). In total
9 of 70 patients treated with glepaglutide were weaned off
parenteral support, while no placebo treated patients were able to
wean off parenteral support. Glepaglutide treatment appeared to be
safe and was well-tolerated in the trial.
- Reported results from the Boehringer
Ingelheim-sponsored Phase 2 clinical trial of BI 456906, a glucagon
receptor/glucagon-like peptide-1 receptor (GCGR/GLP-1R) dual
agonist, in patients with type 2 diabetes (T2D) at the 58th Annual
Meeting of the European Association for the Study of Diabetes
(EASD). Treatment with BI 456906 resulted in dose
dependent HbA1c reductions, with a mean of up to -1.88% at Week 16
compared with -0.25% seen with placebo. Treatment with open-label
weekly semaglutide at 1.0 mg led to a decrease in HbA1c of -1.47%.
The safety and tolerability profile, which included
gastrointestinal disorders (such as nausea and vomiting) as the
most frequently reported adverse events, was as is expected with
higher increasing doses of GLP-1 receptor agonists. Most adverse
events were reported during the dose-escalation phase of the trial,
and therefore slower escalation schemes may mitigate the frequency
of such events.
- Presented results from the Phase 3 clinical trial of
dasiglucagon in congenital hyperinsulinism (CHI) at the 60th Annual
Meeting of the European Society for Paediatric Endocrinology
(ESPE). Dasiglucagon significantly reduced the requirement
for intravenous glucose to maintain glycemia in newborns and
infants with CHI (Part 1 of Phase 3 trial). Dasiglucagon reduced
time in hypoglycemia and enabled discontinuation of intravenous
glucose in most infants and limited the need for pancreatectomy
(Part 2 of Phase 3 trial). Results support the potential for
dasiglucagon to be a novel, effective, and well tolerated treatment
for infants with CHI dependent on intravenous glucose.
- Completed dose escalation in the ongoing Phase 1a
single ascending dose (SAD) trial of ZP8396, a long-acting amylin
analogue. In this Phase 1 SAD trial, subcutaneous ZP8396
appeared to be well tolerated with no unexpected side effects and
the single administration maximum tolerated dose (MTD) was reached.
The pharmacokinetic (PK) profile is suitable for once weekly
dosing. Zealand expects to initiate dosing in a Phase 1b multiple
ascending dose (MAD) trial of ZP8396 by the end of 2022.
- Announced a global license and development agreement
with Novo Nordisk to commercialize ZEGALOGUE® (dasiglucagon) for
injection. Agreement includes an upfront payment,
development, regulatory, manufacturing and sales-based milestones
of up to DKK 290 million to Zealand in addition to high-single to
low-double digit royalties on worldwide net sales by Novo Nordisk.
Zealand will be responsible for certain planned development,
regulatory, and manufacturing activities to support approval
outside the U.S. to be reimbursed by Novo Nordisk.
- Appointed Henriette Wennicke as Chief Financial
Officer. Henriette Wennicke brings broad finance and
business experience at large organizations, including in
healthcare, where she has led financial planning, R&D portfolio
management and investor relations.
- Completed voluntary delisting of its American
Depositary Shares (ADSs) from the New York-based Nasdaq Global
Select Market. One ADS currently represents one ordinary
share in Zealand and on suspension of trading the company’s ADSs
accounted for less than 1.5% of the total share capital. Trading in
Zealand shares is consolidated to Nasdaq Copenhagen, the company’s
primary and most liquid stock exchange. The decision is part of
Zealand’s strategy to prioritize R&D and streamline corporate
operations.
Events after the reporting date
- Presented preclinical data at the Annual Meeting of the
Obesity Society (Obesity Week) on Zealand’s amylin
analogue (ZP8396); its first-in-class GLP-1R/GLP-2R dual agonist
(dapiglutide); and the GIP analogue (ZP6590).
- Reported results from the Boehringer
Ingelheim-sponsored Phase 2 clinical trial of BI 456906
(GCGR/GLP-1R) in patients with T2D at Obesity Week. BI
456906 resulted in dose-dependent bodyweight reductions of up to
-9% at Week 16.
- Phase 2 trial of BI 456906 in patients with
non-alcoholic steatohepatitis (NASH) conducted by
Boehringer Ingelheim has completed patient enrollment.
- Received gross proceeds of DKK 786 million from a
directed issue and private placement. Zealand issued a
total of 4,975,000 new shares at a subscription price of DKK 158
per share.
Upcoming events
- Initiate Phase 1b MAD trial of ZP8396, a
long-acting amylin analogue in development for obesity by the end
of the fourth quarter 2022.
- Interim Phase 3 data from EASE-SBS 2 and 3 long term
extension trials of glepaglutide expected by the end of
the fourth quarter 2022, and first quarter of 2023,
respectively.
- Potential submission of new drug application
(NDA) with the U.S. Food and Drug Administration (FDA) for
dasiglucagon treatment in the management of CHI in the first half
of 2023, based on data from the full Phase 3 program.
Financial guidance for 2022
The company will no longer provide guidance on net product
revenue, reflecting the completion of the asset purchase agreement
for V-Go® with MannKind Corporation and the completion of the
global license and development agreement for Zegalogue® with Novo
Nordisk.
In 2022, Zealand expects revenue from existing license
agreements. However, since such revenue is uncertain in terms of
size and timing, Zealand does not intend to provide guidance on
such revenue.
Net operating expenses in 2022 are expected to be DKK 1,000
million +/-10%*. This is unchanged from our updated guidance issued
on March 30, 2022. *Excluding discontinued operations
Conference call today at 4 PM CET / 10 AM
ET
Zealand’s management will host a conference call today at 4 PM
CET / 10 AM ET to present results through the first nine months of
2022 followed by a Q&A session. Participating in the call will
be Chief Executive Officer Adam Steensberg, Chief Financial Officer
Henriette Wennicke, and Chief Medical Officer David Kendall. The
conference call will be conducted in English.
Telephone dial-in information and a unique personal access PIN
will be provided upon registration at
https://register.vevent.com/register/BI2233344c2eff4f40be51448707df4e03.
A live listen-only audio webcast of the call, including an
accompanying slide presentation, will be accessible at
https://edge.media-server.com/mmc/p/untoz3rk. Participants are
advised to register for the call or webcast approximately 10
minutes before the start. A recording of the event will be
available following the call on the Investor section of Zealand’s
website at https://www.zealandpharma.com/events-cal.
Total number of shares and voting rights in Zealand
Pharma A/S as of September 30, 2022
Number of shares (nominal value of DKK 1 each): 46,538,186 which
is an increase of 2,895,044 from 43,634,142 as reported on December
31, 2021.
Therefore, the current share capital is (nominal value in DKK):
46,538,186.
Number of voting rights: 46,538,186.
On October 4, 2022, The Group announced that a directed issue
and private placement of 4,975,000 new shares had been completed.
Please refer to note 17 for further information.
About Zealand Pharma A/S
Zealand Pharma A/S (Nasdaq: ZEAL) ("Zealand") is a biotechnology
company focused on the discovery and development of peptide-based
medicines. More than 10 drug candidates invented by Zealand have
advanced into clinical development, of which two have reached the
market and three candidates are in late-stage development. The
company has development and partnerships with a number of blue-chip
pharma companies as well as commercial partnerships for its
marketed products. Zealand was founded in 1998 and is headquartered
in Copenhagen, Denmark, with a presence in the U.S. that includes
Boston. For more information about Zealand’s business and
activities, please visit www.zealandpharma.com.
Safe Harbor / Forward-Looking Statements
This press release and interim report contains "forward-looking
statements", as that term is defined in the Private Securities
Litigation Reform Act of 1995 in the United States, as amended,
even though no longer listed in the United States this is used as a
definition to provide Zealand Pharma’s expectations or forecasts of
future events regarding the research, development and
commercialization of pharmaceutical products, the timing of the
company’s preclinical and clinical trials and the reporting of data
therefrom and the company’s Upcoming Events and Financial Guidance
for 2022. These forward-looking statements may be identified by
words such as "aim," "anticipate," "believe," "could," "estimate,"
"expect," "forecast," "goal," "intend," "may," "plan," "possible,"
"potential," "will," "would" and other words and terms of similar
meaning. You should not place undue reliance on these statements,
or the scientific data presented. The reader is cautioned not to
rely on these forward-looking statements. Such forward-looking
statements are subject to risks, uncertainties and inaccurate
assumptions, which may cause actual results to differ materially
from expectations set forth herein and may cause any or all of such
forward-looking statements to be incorrect, and which include, but
are not limited to, unexpected costs or delays in clinical trials
and other development activities due to adverse safety events or
otherwise; unexpected concerns that may arise from additional data,
analysis or results obtained during clinical trials; our ability to
successfully market both new and existing products; changes in
reimbursement rules and governmental laws and related
interpretation thereof; government-mandated or market-driven price
decreases for our products; introduction of competing products;
production problems; unexpected growth in costs and expenses; our
ability to effect the strategic reorganization of our businesses in
the manner planned; failure to protect and enforce our data,
intellectual property and other proprietary rights and
uncertainties relating to intellectual property claims and
challenges; regulatory authorities may require additional
information or further studies, or may reject, fail to approve or
may delay approval of our drug candidates or expansion of product
labeling; failure to obtain regulatory approvals in other
jurisdictions; exposure to product liability and other claims;
interest rate and currency exchange rate fluctuations; unexpected
contract breaches or terminations; inflationary pressures on the
global economy; political uncertainty, including due to the ongoing
military conflict in Ukraine; and the direct and indirect impacts
of the ongoing COVID-19 pandemic on our business, results of
operations and financial condition. If any or all of such
forward-looking statements prove to be incorrect, our actual
results could differ materially and adversely from those
anticipated or implied by such statements. The foregoing sets forth
many, but not all, of the factors that could cause actual results
to differ from our expectations in any forward-looking statement.
All such forward-looking statements speak only as of the date of
this press release and are based on information available to
Zealand Pharma as of the date of this release. We do not undertake
to update any of these forward-looking statements to reflect events
or circumstances that occur after the date hereof. Information
concerning pharmaceuticals (including compounds under development)
contained within this material is not intended as advertising or
medical advice.
NOTE: DKK/USD Exchange rates used: September 30, 2022 = 7.629
and September 30, 2021 = 6.422
V-Go® is a registered trademark of MannKind Corporation and
Zegalogue® is a registered trademark of Novo Nordisk A/S
Contacts:
Anna Krassowska,
PhD |
Vice President,
Investor Relations & Corporate Communications |
Zealand
Pharma |
Email:
ank@zealandpharma.com |
|
David Rosen (U.S.
Media) |
Argot
Partners |
Email: media@zealandpharma.com |
- Zealand Pharma Q3 2022 - Interim Report
Zealand Pharma AS (NASDAQ:ZEAL)
Gráfico Histórico do Ativo
De Mai 2024 até Jun 2024
Zealand Pharma AS (NASDAQ:ZEAL)
Gráfico Histórico do Ativo
De Jun 2023 até Jun 2024