Zealand Pharma Announces Financial Results for the First Nine Months of 2023
09 November 2023 - 7:00AM
Zealand Pharma Announces Financial Results for the First Nine
Months of 2023
Company announcement - No. 38 / 2023
Zealand Pharma Announces Financial Results for the First
Nine Months of 2023
Strong progress across obesity pipeline, first PDUFA date for
dasiglucagon in CHI in 2023 and solid financial position
- Boehringer Ingelheim advances GCGR/GLP-1R dual agonist
survodutide (BI456906) into Phase 3 trials in obesity
- Zealand presents amylin analog ZP8396 6-week trial results at
ObesityWeek and initiates GLP-1R/GLP-2R dual agonist dapiglutide
13-week dose titration trial
- Zealand to host Obesity R&D Event in London on December
5th
- Dasiglucagon for congenital hyperinsulinism granted Priority
Review with December 30, 2023 PDUFA date for up to three weeks of
dosing; plans to make product available in the US as soon as
possible following potential approval
- Revenue recognized for expected milestone payments from
existing partnerships of EUR 30 million and USD 10 million
respectively, contributing to the solid financial position
Copenhagen, Denmark, November 9, 2023 – 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, 2023, and provided a corporate
update.
Building momentum into 2024
Adam Steensberg, President and Chief Executive Officer at
Zealand Pharma said:
“Survodutide advancing into global Phase 3 trials in obesity by
Boehringer Ingelheim is a significant step for Zealand. At the same
time, I am truly excited about the acceleration we are seeing with
our pipeline of wholly owned and differentiated obesity candidates.
We look forward to sharing more of the scientific and clinical
rationale behind these assets at our Obesity R&D Event on
December 5. Finally, we will end this transformative year with a
planned NDA submission for glepaglutide in short bowel syndrome and
the first PDUFA date for dasiglucagon in congenital
hyperinsulinism.”
Key financial results for Q3 2023
year-to-date
DKK million |
Q3-23 YTD |
Q3-22 YTD* |
Revenue |
319,553 |
80,061 |
Net operating expenses1 |
-633,150 |
-676,245 |
Net operating result |
-313,597 |
-596,184 |
Net financial items |
-124,785 |
-53,421 |
Cash position2 |
1,582,189 |
729,886 |
Funding available incl. undrawn committed RCF3 |
1,932,189 |
729,886 |
*Comparative numbers are adjusted for discontinued
operations.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.3. RCF =
Revolving Credit Facility provided by Danske Bank. |
Recent highlights
Rare diseases
- Dasiglucagon (CHI): FDA granted a priority review for
the prevention and treatment of hypoglycemia in pediatric patients
7 days of age and older with congenital hyperinsulinism (CHI) for
up to three weeks of dosing with a Prescription Drug User Fee Act
(PDUFA) date on December 30, 2023. The regulatory review
will be conducted in two parts under the same NDA. Part 1 relates
to dosing of up to three weeks. Part 2 relates to use beyond three
weeks, in support of which the FDA has requested additional
analyses from existing continuous glucose monitoring (CGM)
datasets, included as a secondary outcome measure in the Phase 3
program.
Obesity
- Survodutide (BI 456906), a glucagon/GLP-1 receptor dual
agonist: Boehringer Ingelheim announced Phase 3 program in people
living with overweight or obesity. SYNCHRONIZE™-1 and
SYNCHRONIZE™-2 are designed to evaluate survodutide in people
living with overweight or obesity without and with type 2 diabetes,
respectively. SYNCHRONIZE™-CVOT is a long-term cardiovascular
safety trial of survodutide in people living with overweight or
obesity with cardiovascular disease, chronic kidney disease or with
risk factors for cardiovascular disease. The Phase 3 trials include
a longer treatment period (76 weeks) and a higher maximum
maintenance dose (6.0 mg) compared with Phase 2.
- ZP8396, a long-acting amylin analog: Presented results
at Obesity Week from 6-week MAD trial. In Part 1 of the
Phase 1b trial, low doses of up to 1.2 mg ZP8396 administered once
weekly for only six weeks led to reductions in body weight of up to
5.3% in healthy lean and overweight participants (mean body weight
of 82 kg and BMI of 25.4) and were well tolerated with a mostly
mild adverse event profile.
- Dapiglutide, a first-in-class GLP-1/GLP-2 receptor dual
agonist: Initiated 13-week dose titration trial. The trial
is evaluating dapiglutide in healthy overweight or obese
participants (eligible BMI 27.0–39.9) and aims to include higher
maximum maintenance doses than were used in the prior 4-week MAD
trial and the ongoing investigator-led DREAM trial.
Financial
- Solid financial position. Milestone payments
from existing partnerships were recognized in the third quarter of
2023, with cash inflow expected in the fourth quarter of 2023,
contributing to the company’s solid financial position. These
potential milestones include EUR 30 million from Boehringer
Ingelheim associated with survodutide and USD 10 million from
Sanofi associated with lixisenatide.
Obesity R&D Event for investors and
analysts
- Zealand management together with key external experts in the
obesity field, Professor Daniel Drucker, Professor Louis Aronne,
and Professor Carel Le Roux, will be hosting an Obesity R&D
event in London on December 5th to discuss the scientific rationale
and clinical potential of the company’s differentiated product
candidates. Please visit
https://www.zealandpharma.com/event/zealand-pharmas-obesity-rd-event/
to register for this event.
Upcoming events next 12
months
Rare diseases
- Dasiglucagon in CHI. The FDA has granted a
December 30, 2023, PDUFA date for dasiglucagon for the prevention
and treatment of hypoglycemia in pediatric patients 7 days of age
and older with congenital hyperinsulinism (CHI) for up to three
weeks of dosing. If approved, Zealand plans to make dasiglucagon
available to healthcare professionals and patients in the US as
soon as possible. In addition, the company expects to submit Part 2
of the NDA that includes analyses of CGM data to support the use of
dasiglucagon in CHI beyond three weeks in the first half of 2024.
Zealand continues to engage in partnership discussions for
commercialization of the product.
- Glepaglutide in SBS. In the fourth quarter of
2023, Zealand expects to submit an NDA to the FDA for glepaglutide
administered via autoinjector for the treatment of short bowel
syndrome with intestinal failure and subsequently engage in more
detailed partnership discussions.
Obesity
- Survodutide in NASH. Boehringer Ingelheim and
Zealand Pharma expect to report topline results from the Phase 2
trial with survodutide in NASH in the first half of 2024.
- Dapiglutide. In the first half of 2024,
Zealand anticipates topline results from the ongoing
investigator-led DREAM trial that aims to evaluate the potential
for weight loss following 12 weeks of treatment and gain key
mechanistic insights into the effects of dapiglutide on
inflammatory markers. In the second half of 2024, Zealand expects
topline results from the 13-week dose titration trial.
- ZP8396, amylin analog. In the first half of
2024, Zealand expects to report topline results from Part 2 of the
MAD trial that is evaluating ZP8396 in participants with overweight
or obesity (eligible BMI 27.0–39.9), including higher doses
compared with Part 1 and over a longer 16-week treatment
period.
- ZP6590, GIP analog. Zealand has completed
pre-clinical activities to support potential first-in-human
clinical trials in 2024.
Chronic inflammation
- ZP10068, Complement Inhibitor. Zealand has
completed pre-clinical and CMC activities for the investigational
long-acting complement inhibitor. Subsequent regulatory, clinical
and development efforts will be led and conducted by Alexion.
- ZP9830, Kv1.3 Ion Channel Blocker. Zealand has
completed pre-clinical activities for the Kv1.3 ion channel blocker
to support potential first-in-human clinical trials in 2024.
Financial guidance for 2023
- Guidance unchanged from March 2, 2023
DKK million |
2023 Guidance |
2022 Actual |
Revenue anticipated from existing and new license and partnership
agreements |
No guidance due to uncertain size and timing |
104 |
Net operating expenses4 |
800-900 |
941 |
Notes:4. Financial guidance based on foreign exchange rates as of
November 9, 2023. |
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 nine
months of 2023 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/BId73e050fc44d47be81015697a873e070.
The live listen-only audio webcast of the call and accompanying
slide presentation will be accessible at
https://edge.media-server.com/mmc/p/b9gpnynv. 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 2024
FY/Q4 2023Q1 2024Q2 2024Q3 2024 |
February 27, 2024May 16, 2024August 15, 2024November 7, 2024 |
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 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 Lange |
Investor
Relations Officer |
Zealand
Pharma |
Email:
ALange@zealandpharma.com |
|
Anna Krassowska,
PhD |
Vice President,
Investor Relations & Corporate Communications |
Zealand
Pharma |
Email:
AKrassowska@zealandpharma.com |
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