Zealand Pharma Announces Financial Results for the First Nine Months of 2024
07 November 2024 - 7:00AM
UK Regulatory
Zealand Pharma Announces Financial Results for the First Nine
Months of 2024
Company announcement – No. 49 / 2024
Zealand Pharma Announces Financial Results for the First Nine
Months of 2024
Continued strong progress across obesity pipeline with
proprietary assets ready for Phase 2 backed by a solid financial
position.
- Presented extremely encouraging weight loss and tolerability
data with long-acting amylin analog petrelintide from MAD Part 2
(16-week trial) at ObesityWeek 2024
- Announced positive topline results with GLP-1R/GLP-2R dual
agonist dapiglutide from Part 1 of Phase 1b trial (13-week
trial)
- Boehringer Ingelheim announced US FDA Breakthrough Therapy
Designation and advancement to two large Phase 3 trials for
survodutide in MASH
Copenhagen, Denmark, November 7, 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
nine months ended September 30, 2024, and provided a corporate
update.
Building momentum into 2025 following impressive data across
obesity portfolio
Adam Steensberg, President and Chief Executive Officer at
Zealand Pharma said:
“I am excited about the impressive data and continued clinical
advancement across our portfolio of differentiated obesity
candidates that recently included very encouraging topline data
with dapiglutide, advancement by Boehringer Ingelheim of
survodutide into an ambitious Phase 3 program in MASH, and of
course the presentation of data with our potentially best-in-class
amylin analog petrelintide. With petrelintide specifically, I
believe we have a unique opportunity to develop an alternative to
GLP-1RA-based therapies that could become the future foundational
therapy for weight management. We look forward to initiating a
large, comprehensive Phase 2b trial very soon and are now exploring
collaboration opportunities with potential partners.”
Key financial results for Q3 2024 year-to-date
DKK million |
Q3-24
YTD |
Q3-23
YTD |
Revenue |
53.6 |
319.6 |
Net operating expenses1 |
-919.1 |
-633.2 |
Net operating result |
-872.9 |
-318.8 |
Net financial items |
81.1 |
-124.8 |
DKK million |
Sep-30,
2024 |
Dec-31,
2023 |
Cash position2 |
9,195.3 |
1,633.1 |
Notes:
- Net operating expenses consist of R&D, S&M, G&A and
other operating items.
- Cash position includes cash, cash equivalents and marketable
securities.
Highlights in the third quarter of 2024
Obesity
- Dapiglutide, GLP-1/GLP-2 receptor dual agonist: Reported
positive topline data from Part 1 of the Phase 1b dose titration
trial. Topline results showed placebo-adjusted reductions in
body weight of up to a mean of 8.3% with dapiglutide after 13
weekly doses. 85% of the 54 trial participants were male and median
BMI at baseline was 30 kg/m2. Dapiglutide treatment with
doses up to 13 mg was assessed to be safe and well-tolerated with
gastrointestinal (GI) adverse events (AEs) consistent with the
profile reported with other incretin-based therapies. Only two
participants discontinued treatment due to GI AEs.
Corporate
- Appointed Eric Cox as Chief Commercial Officer. Eric
will lead Zealand Pharma’s commercial strategy and assume
responsibility for business development.
Events after the reporting date
Obesity
- Petrelintide, long-acting amylin analog: Presented detailed
results at ObesityWeek 2024 from 16-week multiple ascending dose
(MAD) trial, Part 2 of Phase 1b trial. Petrelintide
demonstrated mean body weight reductions of 4.8%, 8.6% and 8.3%
after 16 once-weekly doses of up to 2.4 mg, 4.8 mg and 9.0 mg,
respectively, versus 1.7% for the pooled placebo group. Dose
escalation within cohorts occurred every second week. Participants
randomized to petrelintide received the three different maintenance
doses of 2.4 mg, 4.8 mg and 9.0 mg for twelve, eight and six weeks,
respectively. 79% of the 48 trial participants were male and mean
BMI was 29.9 kg/m2. Petrelintide was well tolerated,
with no serious or severe adverse events. All gastrointestinal
adverse events were mild, except for two moderate events (nausea
and vomiting) reported in one participant who discontinued
treatment. No other participants discontinued treatment due to AEs.
No other events of vomiting occurred, and two events of diarrhea
were reported, both of which were mild.
MASH
- Survodutide, glucagon/GLP-1 receptor dual agonist:
Boehringer Ingelheim announced U.S. FDA Breakthrough Therapy
Designation and initiation of two Phase 3 trials in MASH.
LIVERAGE and LIVERAGE-Cirrhosis are global Phase 3 clinical trials
investigating the efficacy and safety of survodutide in adults with
metabolic dysfunction-associated steatohepatitis (MASH) and
fibrosis stages 2 or 3 and in those with compensated MASH cirrhosis
(stage 4), respectively. Based on the groundbreaking results from
the Phase 2 trial in MASH, survodutide has received U.S. FDA
Breakthrough Therapy Designation for the treatment of adults with
non-cirrhotic MASH and moderate or advanced fibrosis.
Rare diseases
- Dasiglucagon in congenital hyperinsulinism (CHI): The U.S.
FDA issued a Complete Response Letter (CRL) for dasiglucagon in CHI
for up to three weeks of dosing due to the timing of a third-party
manufacturing facility reinspection. The reinspection of the
facility was completed in August/September 2024 for which a new
inspection classification is pending. A prior inspection of the
facility had identified deficiencies that did not involve
dasiglucagon. These prior deficiencies had been resolved as of this
reinspection. The CRL did not state any concerns about the clinical
data package or safety of dasiglucagon.
Upcoming events next 12 months
Obesity
- Petrelintide, amylin analog: advancing clinical
development. Zealand Pharma expects to initiate a Phase 2b
trial with petrelintide in people with overweight or obesity
without type 2 diabetes in the fourth quarter of 2024, for which
completion of enrollment is expected in the first half of 2025.
Zealand also expects to initiate a Phase 2b trial in people with
overweight or obesity and type 2 diabetes in the first half of
2025.
- Zealand also plans to initiate a Phase 1b combination trial
with petrelintide and a GLP-1 receptor agonist in 2025.
- Dapiglutide, a GLP-1/GLP-2 receptor dual agonist. In the
first half of 2025, Zealand Pharma expects to announce topline
results from a cohort (Part 2 of the Phase 1b trial) evaluating
even higher doses up to 26 mg dapiglutide and with 28 weeks of
treatment. The cohort was added based on dapiglutide’s tolerability
profile observed to date and will have no impact on the timing for
initiation of a Phase 2b trial in people with overweight or obesity
also expected in the first half of 2025. Zealand also plans to
present the results from the Phase 1b trial at a scientific
congress in 2025.
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. Contingent on an inspection
classification upgrade of the third-party manufacturing facility,
Zealand expects to resubmit Part 1 of the NDA for dasiglucagon in
CHI for up to three weeks of dosing in the fourth quarter of 2024.
For Part 2 of the NDA review, which relates to use beyond three
weeks, Zealand expects to submit the additional analyses from
existing continuous glucose monitoring (CGM) datasets requested by
the U.S. FDA in the fourth quarter of 2024 as well. Zealand is
continuing pre-commercial activities to prepare for a launch in the
U.S. contingent on an approval by the FDA. In parallel, the company
is engaging in partnership discussions for future commercialization
of the product.
Chronic inflammation
- ZP9830, Kv1.3 Ion Channel Blocker. Zealand Pharma
expects to initiate the first-in-human clinical trial of ZP9830 in
the fourth quarter of 2024.
Financial guidance for 2024
- Guidance unchanged from August 15, 2024
DKK million |
2024
Guidance |
2023
Actuals |
Revenue anticipated from existing and new license and partnership
agreements
|
No guidance due to uncertain size and timing |
343 |
Net operating expenses3 |
1,250-1,350 |
896
|
Notes:
- Financial guidance based on foreign exchange rates as
of November 7, 2024.
Conference call today at 2 PM CET / 8 AM ET
Zealand’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; Chief Medical Officer, David Kendall;
and Chief Commercial Officer, Eric Cox. 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/BI9feb9ca116c04d17abb506491ebf0b90.
The live listen-only audio webcast of the call and accompanying
slide presentation will be accessible at
https://edge.media-server.com/mmc/p/4kd7ihsh/. 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/investors/events-presentations/.
Financial Calendar for 2025
FY/Q4 2024 |
February 20,
2025 |
Q1 2025 |
May 8, 2025 |
Q2 2025 |
August 14,
2025 |
Q3 2025 |
November 6,
2025 |
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 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 Statements
This 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 2024. 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
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate
Communications
Zealand Pharma
Email: AKrassowska@zealandpharma.com
Adam Lange
Investor Relations Officer
Zealand Pharma
Email: ALange@zealandpharma.com
Neshat Ahmadi
Investor Relations Manager
Zealand Pharma
Email: NeAhmadi@zealandpharma.com
- Zealand Pharma 2024 Q3 Interim Report
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