Company Announcement No. 34 / 2022
Interim report for H1 2022
Zealand Pharma Announces Financial Results for the First
Half of 2022
Copenhagen, DK and Boston, MA, U.S. August 11,
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
financial results for the first half of 2022 and provided a
corporate update.
Key strategic objectives achieved
Adam Steensberg, President and Chief Executive at Zealand Pharma
said: "Zealand has achieved key objectives in executing the
strategy we announced at the end of March to prioritize investment
in R&D and seek partnerships for the company’s commercial
products and late-stage assets. In May, we completed the sale of
V-Go® to MannKind. In the second quarter, we strengthened our
balance sheet through proceeds from a private placement and by
amending an existing financing agreement. Finally, to further
streamline our operating efficiency, we announced the decision this
week to end a non-liquid ADS program. With our R&D focus,
Zealand is now positioned well to leverage the value of our most
advanced assets through business development efforts and develop
new peptide-based therapies through 2022 and beyond.
“Zealand’s R&D pipeline continues to advance in 2022, with
our Phase 3 trial readout in CHI completed, our Phase 3 readout in
short bowel syndrome approaching, and a portfolio of peptides
targeting obesity that is building strong momentum. For our
late-stage pipeline, we announced positive results from a Phase 3
trial of dasiglucagon in children with congenital hyperinsulinism,
which we anticipate submitting as part of a New Drug Application,
or NDA, to the U.S. Food and Drug Administration. At the recent ADA
Scientific Sessions, we presented initial Phase 1 data for
dapiglutide, our dual GLP-1/GLP-2 agonist, showing encouraging
weight-loss in healthy volunteers that supports advancing into
Phase 2 in obesity. Looking ahead, we have just achieved
last-patient-last-visit for the Phase 3 trial with glepaglutide,
our long-acting GLP-2 analogue, with expected top-line results in
patients with SBS at the end of this quarter. We also anticipate
initial Phase 1 clinical data for our amylin analogue and expect
our partner, Boehringer Ingelheim, to present Phase 2 data for the
dual GCGR/GLP-1R agonist BI 456906 in patients with type 2
diabetes.”
Financial results for the first half of
2022
- Revenue: DKK 43.5 million / USD 6.1 million
(DKK 42.3 million / USD 6.8 million in the first six months of
2021).
- Net operating expenses: DKK -502.6 million / USD -70.2
million (DKK -582.4 million / USD -93.1 million in the
first six months of 2021).
- Net operating result: DKK -539.2 million / USD -75.3
million (DKK -551.9 million / USD -88.2 million in the
first six months of 2021).
- Net financial items: DKK -61.8 million / USD -8.6
million (DKK 5.5 million / USD 0.9 million in the first
six months of 2021).
- Net result from Discontinued Operations Related to
Restructuring: DKK -97.9 million / USD -13.7 million (DKK
0.6 million / USD 0.1 million in the first six months of
2021).
- Cash, cash equivalents, and marketable securities: DKK
864.4 million / USD 120.7 million as of June 30, 2022
(June 30, 2021: DKK 1,282.9 million / USD 205.0 million).
Highlights in the second quarter 2022
- Completed sale of V-Go® insulin delivery device to
MannKind Corporation. The Asset Purchase Agreement
included an upfront payment of $10 million USD to Zealand and
sales-based milestones, as well as sale of certain inventory
related to V-Go® and transfer of selected employees.
- Announced that the Phase 3 trial of dasiglucagon in
pediatric patients with congenital hyperinsulinism (CHI) met the
primary endpoint with statistical significance.
Dasiglucagon reduced the requirement for intravenous glucose by 55%
compared to placebo in children ages 7 days to 12 months enrolled
in the trial. An abstract describing these results has been
accepted for presentation at a scientific congress in the third
quarter. Zealand expects data from this Phase 3 trial, together
with data from a previously reported Phase 3 trial in older
children with CHI, to form the basis of a new drug application
(NDA) with the U.S. Food and Drug Administration (FDA) for
dasiglucagon treatment in the management of CHI. The company
anticipates a submission in the first quarter of 2023.
- Received gross proceeds of DKK 274.8 million from a
directed issue and private placement. Zealand issued a
total of 2,892,368 new shares at a subscription price of DKK 95 per
share.
- Appointed David M. Kendall, M.D., as Chief Medical
Officer. Dr. Kendall has more than 35 years of experience
in diabetes and metabolic disease, with a broad career in research,
education, clinical care, and the pharmaceutical industry.
- Presented data from the Phase 1 trial of dapiglutide at
the 82nd American Diabetes Association Scientific Sessions and
announced dapiglutide to move into Phase 2 trial for
obesity. The Phase 1 results of dapiglutide, a dual
GLP-1R/GLP-2R agonist, demonstrated dose dependent weight loss of
up to 4.3% of baseline body weight after only four weeks of
treatment. The pharmacokinetic profile was predictable with a
half-life suitable for once-weekly dosing.
- Amended Note Purchase Agreement with Oberland
Capital. Zealand repurchased $50.0 million of note
principal with a 1.2x prepayment premium. The agreement includes
potential for a further $75 million incremental capital following
specific events and removes the liquidity covenant.
Events after the reporting date
- Announced intention to voluntarily remove its American
Depositary Shares (ADSs) from listing on the New York-based Nasdaq
Global Select Market. One ADS currently represents one
ordinary share in Zealand and today the company’s ADSs account for
less than 1.5% of the total share capital. Zealand will consolidate
trading to Nasdaq Copenhagen, the company’s primary and most liquid
stock exchange. The decision is part of Zealand’s refocused
strategy to prioritize R&D and streamline corporate
operations.
Events anticipated in 2022
- Top-line results from the Phase 3 trial of
glepaglutide, a long-acting GLP-2 analog, in patients with
short bowel syndrome (SBS)
- Scientific congress presentation of results from the
Phase 2 trial with BI 456906, a long-acting dual
GCGR/GLP-1R agonist developed in collaboration with Boehringer
Ingelheim, in patients with type 2 diabetes
- Initiation of Phase 1b multiple ascending dose trial of
ZP8396, a long-acting amylin analogue in development for
obesity
- Financial results for the third quarter of
2022 expected on November 10, 2022
Financial guidance for 2022
Net product revenue from the sales of Zegalogue is expected to
be DKK 11.5 million +/- 10%. This is a reduction of DKK 7.5 million
from our updated guidance issued on May 12, 2022, reflecting the
completion of the Asset Purchase Agreement for V-Go with MannKind
Corporation. The company will no longer provide guidance on net
product revenue associated with sales from that program.
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 and is a decrease of DKK 200 million from the
guidance issued on March 10, 2022.
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 six months of
2022 followed by a Q&A session. Participating in the call will
be Chief Executive Officer Adam Steensberg, Chief Financial Officer
Matt Dallas, 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/BI0687000737bf4bdda7d667f72d07be30.
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/xmmfib4z. 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 as of June 30, 2022
Number of shares (nominal value of DKK 1 each): 46,526,510 which
is an increase of 2,892,368 from 43,643,142 as reported on December
31, 2021.
Therefore, the current Share capital is (nominal value in DKK):
46,526,510
Number of voting rights: 46,526,510
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. In addition, license
collaborations with Boehringer Ingelheim and AstraZeneca create
opportunities for more patients to potentially benefit from
Zealand-invented peptide investigational agents currently in
development.
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, as amended, that 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 clinical trials and the
reporting of data therefrom and the company’s Events Anticipated in
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; 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: June 30, 2022 = 7.163 and
June 30, 2021 = 6.257
Contacts:
Anna Krassowska, PhDVice President, Investor Relations &
Corporate CommunicationsZealand PharmaEmail:
ank@zealandpharma.com
David Rosen (U.S. Media)Argot PartnersEmail:
media@zealandpharma.com
- Zealand Pharma Interim Report Q2H1 2022
Zealand Pharma AS (NASDAQ:ZEAL)
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