Zealand Pharma Announces Financial Results for the First Half of 2024
15 Agosto 2024 - 12:00AM
Company announcement - No. 39 / 2024
Zealand Pharma Announces Financial Results for the First
Half of 2024
Very strong progress across R&D pipeline followed by
substantial capital raise enabling further investments to
accelerate the development programs for wholly owned obesity
assets.
- Extremely encouraging weight loss and tolerability data
announced with long-acting amylin analog petrelintide from MAD Part
2 (16-week trial)
- Impressive data from Boehringer Ingelheim’s Phase 2 clinical
trial with survodutide in MASH presented at the EASL congress in
Milan, Italy
- Significant strengthening of the balance sheet with completion
of upsized equity offering raising gross proceeds of DKK 7 billion
/ USD 1 billion, which enables further investments to accelerate
the development of our differentiated obesity assets resulting in a
guidance update of net operating expenses to DKK 1.25 – 1.35
billion for 2024
Copenhagen, Denmark, August 15, 2024 – 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
six months ended June 30, 2024, and provided a corporate
update.
Phenomenal first half of 2024 with impressive data in
obesity followed by one of the strongest ever capital raises in
EuropeAdam Steensberg, President and Chief Executive
Officer at Zealand Pharma said:“I am very pleased with our progress
in the first six months of 2024 that included impressive data
across the obesity portfolio. In particular, the 16-week data with
petrelintide reaffirmed our conviction in our amylin analog as an
alternative to GLP-1RA-based therapies with potential to become the
future backbone therapy for weight management. Looking into the
second half of the year, we have an important data read-out for
dapiglutide and potential approvals in the US for both our rare
disease programs. Backed by a very solid financial position
following the extraordinary capital raise in June, we are investing
significantly in our differentiated obesity candidates to
accelerate the development programs as we explore partnership
opportunities.”
Key financial results for H1 2024
DKK million |
H1 2024 |
H1 2023 |
Revenue |
49.2 |
24.0 |
Net operating expenses1 |
-558.7 |
-388.1 |
Net operating result |
-523.5 |
-364.0 |
Net financial items |
-0.5 |
-152.3 |
DKK million |
Jun-30, 2024 |
Dec-31, 2023 |
Cash position2 |
9,747.7 |
1,633.1 |
Notes:1. Net operating expenses consist of R&D, S&M,
G&A and other operating items.2. Cash position includes cash,
cash equivalents and marketable securities. Revolving Credit
Facility is not included.
Highlights in the second quarter
2024Obesity
- Petrelintide, amylin analog: Reported positive topline
data from the 16-week multiple ascending dose (MAD) trial, Part 2
of the Phase 1b trial. Topline results showed mean body
weight reductions of up to 8.6% after 16 weeks with once-weekly
dosing of petrelintide using a dose escalation scheme, versus 1.7%
mean body weight reduction for the pooled placebo group. 79% of the
48 trial participants were male and median BMI was 29 kg/m2.
Petrelintide was very well tolerated, with no serious or severe
adverse events (AEs). All gastrointestinal (GI) AEs were mild,
except for two moderate events (nausea and vomiting) reported in
one participant who discontinued treatment. No other trial
participants discontinued treatment due to AEs. No other events of
vomiting occurred, and two events of diarrhea were reported, both
of which were mild.
- Dapiglutide, GLP-1/GLP-2 receptor dual agonist:
Reported topline data from the mechanistic investigator-led trial
DREAM with low doses of dapiglutide. Topline results
showed mean weight loss of up to 4.3% after 12 weeks with low doses
of dapiglutide treatment. Dapiglutide was assessed to be well
tolerated, with no treatment emergent adverse events (TEAEs)
leading to treatment discontinuation and fewer GI TEAEs compared to
what have been reported from other trials with incretin-based
therapies, suggesting that doses of dapiglutide investigated were
at the lower end of the therapeutic range in an obesity setting.
Higher doses of dapiglutide are being investigated in the ongoing
Phase 1b trial, with topline results from Part 1 of the trial
exploring doses of dapiglutide up to 13 mg over 13 weeks of
treatment expected in the second half of 2024. Additional data from
DREAM on cardiovascular risk, systemic inflammatory markers, as
well as data from gut biopsies, will be presented at a future
scientific meeting.
MASH
- Survodutide, glucagon/GLP-1 receptor dual agonist:
Boehringer Ingelheim presented breakthrough results at the EASL
congress from Phase 2 trial in MASH. The detailed results
showed that up to 64.5% of adults with fibrosis stages F2 and F3
(moderate to advanced scarring) achieved a biopsy-proven
improvement in fibrosis without worsening of metabolic
dysfunction-associated steatohepatitis (MASH) after 48 weeks of
survodutide treatment, versus 25.8% with placebo. Survodutide
demonstrated safety data consistent with GLP-1RA-based molecules,
with no new safety data concerns. Boehringer Ingelheim confirmed
that survodutide will advance into Phase 3 for the potential
treatment of MASH.
Financial
- Solid financial position. Completed an upsized
equity offering of 8.35 million new ordinary shares raising gross
proceeds of USD 1 billion / DKK 7 billion representing one of the
strongest ever capital raises in Europe. The net proceeds will
support the advancement of Zealand’s proprietary obesity programs
in Phase 2b clinical trials and beyond, including investments in
associated CMC activities and additional clinical development
activities in related indications. The net proceeds will also
support continued early-stage research and fund general corporate
purposes.
Events after the reporting dateType 1
diabetes
- Zegalogue® (dasiglucagon injection for severe
hypoglycemia) approval in the EU. The European Commission
granted marketing authorization for dasiglucagon injection for the
treatment of severe hypoglycemia in adults, adolescents and
children aged six years or older with diabetes in Europe under the
brand name Zegalogue®. Zegalogue® is licensed to Novo Nordisk who
is responsible for commercialization worldwide.
Corporate
- Appointed Eric Cox as Chief Commercial
Officer. Eric will lead Zealand’s commercial strategy and
assume responsibility for business development.
Financial
- Terminated the Revolving Credit Facility provided by
Danske Bank. The Revolving Credit Facility of DKK 350
million provided by Danske Bank was terminated in July 2024
following the equity offering in June 2024 that resulted in a cash
position of DKK 9.7 billion as of June 30, 2024.
Upcoming events in 2024Obesity
- Petrelintide, amylin analog. Detailed results
from Part 2 of the MAD trial to be presented at a scientific
congress in the coming months. In the second half of 2024, Zealand
expects to initiate the Phase 2b program with petrelintide in
people with overweight or obesity.
- Dapiglutide, a GLP-1/GLP-2 receptor dual
agonist. In the second half of 2024, Zealand expects to
report topline results from Part 1 of the Phase 1b dose titration
trial, evaluating doses of dapiglutide treatment up to 13 mg and
thus significantly higher doses compared to the prior 4-week MAD
trial and the investigator-led trial DREAM. Based on the
tolerability profile observed to date, a cohort (Part 2 of the
Phase 1b trial) evaluating even higher doses up to 26 mg and with
28 weeks of treatment has been added, with topline results expected
in the first half of 2025. The added cohort will have no impact on
the expected timing for initiation of a Phase 2b trial in the first
half of 2025.
- Survodutide in MASH. In the second half of
2024, Boehringer Ingelheim is expected to initiate the Phase 3
program with survodutide in MASH. The Phase 3 program with
survodutide in obesity, SYNCHRONIZETM, was initiated in 2023.
Rare diseases
- Glepaglutide in SBS. US FDA has set a
Prescription Drug User Fee Act (PDUFA) date on December 22, 2024.
In parallel with the regulatory review process, Zealand is engaging
in partnership discussions for future commercialization.
- Dasiglucagon in CHI. US FDA has set a PDUFA
date on October 8, 2024 for Part 1 of the NDA review related to
dosing of up to three weeks. For Part 2 of the NDA review, which
relates to use beyond three weeks, the US FDA requested additional
analyses from existing continuous glucose monitoring (CGM)
datasets, which Zealand expects to submit in the second half of
2024. CGM was included as a secondary outcome measure in the Phase
3 program. Zealand is engaging in partnership discussions for
future commercialization of the product. In parallel, Zealand
intends to make the product available to patients in the US
contingent on an approval by the FDA in October 2024 for up to
three weeks of dosing.
Chronic inflammation
- ZP9830, Kv1.3 Ion Channel Blocker. Zealand
expects to initiate the first-in-human clinical trial of ZP9830 in
the second half of 2024.
Financial guidance for 2024
- Following the capital raise in June 2024, our significantly
strengthened cash position provides a unique opportunity to
accelerate the development programs of our differentiated obesity
assets.
- Guidance updated compared to February 27, 2024
DKK million |
2024 Guidance(15 August) |
2024 Guidance(27 February) |
Revenue anticipated from existing and new license and partnership
agreements |
No guidance due to uncertain size and timing |
No guidance due to uncertain size and timing |
Net operating expenses3 |
1,250-1,350 |
1,100-1,200 |
Notes:3. Financial guidance based on foreign exchange rates as
of August 15, 2024.
Conference call today at 2 PM CET / 8 AM
ETZealand’s management will host a conference call today
at 2:00 PM CET / 8:00 AM ET to present results through the first
six months of 2024 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.
To receive telephone dial-in information and a unique personal
access PIN, please register at
https://register.vevent.com/register/BI317d27d63df44f09bded2febfbe6b52a.
The live listen-only audio webcast of the call and accompanying
slide presentation will be accessible at
https://edge.media-server.com/mmc/p/ya97oe47. 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/.
Financial Calendar for 2024Q3
2024
November 7, 2024
About Zealand Pharma A/SZealand 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 partnerships with a number of 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. For more information about
Zealand’s business and activities, please visit
www.zealandpharma.com.
Forward-looking StatementsThis company
announcement 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 pre-clinical and clinical trials and the reporting of
data therefrom and the company’s Upcoming Events and Financial
Guidance for 2023. 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; and political uncertainty, including due to the
ongoing military conflict in Ukraine. 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/company announcement and are based on
information available to Zealand Pharma as of the date of this
release/announcement. 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.
Zealand Pharma® is a registered trademark of Zealand Pharma
A/S.
Contacts:Adam LangeInvestor Relations
OfficerZealand PharmaEmail: ALange@zealandpharma.com
Anna Krassowska, PhDVice President, Investor Relations &
Corporate CommunicationsZealand PharmaEmail:
AKrassowska@zealandpharma.com
- Zealand Pharma H1 2024 Company Announcement_vFinal