Click
Chat
 
Du kan vedhæfte PDF, JPG, PNG, DOC(X), XLS(X) og TXT-filer. Klik på ikonet, vælg fil og vent til upload er færdig før du indsender eller uploader endnu en fil.
60
Vedhæft Send
DANMARKS STØRSTE INVESTORSITE MED DEBAT, CHAT OG NYHEDER

Zeal Announces Financial Results for the Full Year 2023


118963 ProInvestorNEWS 27/2 2024 07:05
Oversigt

Company announcement - No. 9 / 2024

Zealand Pharma Announces Financial Results for the Full Year 2023

Significant progress delivered across our obesity and rare disease assets while building a solid financial position

Positive results achieved for petrelintide in 6-week Phase 1 trial and clinical advancement of dapiglutide and petrelintide towards obesity data readouts in 2024
Positive results announced in Boehringer Ingelheim Phase 2 clinical trials for survodutide in obesity and global Phase 3 clinical program in obesity initiated
NDA submissions for dasiglucagon in congenital hyperinsulinism and glepaglutide in short bowel syndrome expected to support regulatory decisions for rare diseases in 2024
Private placement of shares to institutional investors, European Investment Bank loan facility, undrawn committed RCF and milestone payments from existing partners contribute to strengthened financial position

Events after the reporting period

Positive results announced in Boehringer Ingelheim Phase 2 clinical trial for survodutide in MASH and private placement of shares to institutional investors contribute to extended cash runway into 2027

Copenhagen, Denmark, February 27, 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 annual report for the year ended December 31, 2023, and provided a corporate update.

Building momentum in 2024

"2023 was an extraordinary year for Zealand and I am proud of our team's performance to progress our business," said Adam Steensberg, President and Chief Executive Officer at Zealand Pharma. "With the promising results for our long-acting amylin analog, petrelintide, and the advancement of our dual GLP-1/GLP-2 receptor agonist, dapiglutide, in obesity, Zealand is well positioned to achieve significant milestones in 2024. We look forward to important clinical results for petrelintide and dapiglutide in obesity that we believe will support advancing both compounds into subsequent Phase 2b trials, and to progressing our rare disease product candidates through the regulatory phase to patients who need them."

Key financial results for FY 2023
DKK million FY 2023 FY 2022
Revenue 342.8 104.0
Net operating expenses1 -895.9 -941.1
Net operating result -572.2 -837.2
Net financial items -136.6 -134.9
Cash position2 1,633.1 1,177.8
Cash position including undrawn committed RCF3, EIB4 loan facility (Tranche A, B and C) and January 2024 private placement5 4,104.0 1,177.8
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.
RCF = Revolving Credit Facility of DKK 350 million provided by Danske Bank.
EIB = European Investment Bank. The conditions for Tranche A (EUR 50 million) have been met. Pay-out expected in Q1 2024. Tranche B (EUR 20 million) and Tranche C (EUR 20 million) are subject to predefined milestones being met.
In January 2024, Zealand received gross proceeds of DKK 1.45 billion in connection with a private placement of new shares.

Maintaining a strong financial position.

Revenue in 2023 of DKK 343 million was mainly driven by a EUR 30 million milestone payment from Boehringer Ingelheim associated with survodutide and USD 10 million from a milestone payment from Sanofi associated with lixisenatide.
Cash position is DKK 4.1 billion including the undrawn committed RCF, the EIB loan facility (tranche A, B and C) and the January 2024 private placement of DKK 1.45 billion. Cash, cash equivalents and marketable securities as of December 31, 2023, was DKK 1.6 billion, including gross proceeds of DKK 1.5 billion from a directed issue and private placement in April 2023.
Under the current assumptions Zealand projects its existing financial resources will be sufficient to fund operations into 2027.

Financial guidance for 2024

The solid financial situation enables Zealand to expand its investments in the company's wholly owned obesity assets and continue investing in progressing the rare disease product candidates through the regulatory phase while engaging in partnership discussions.
DKK million

2024 Guidance 2023 Actual
Revenue anticipated from existing and new license and partnership agreements No guidance due to uncertain size and timing 343
Net operating expenses5 1,100-1,200 896
Notes:
5. Financial guidance based on foreign exchange rates as of February 26, 2024.



Recent R&D highlights and key events anticipated in 2024

Obesity - advancing the portfolio

Petrelintide, a long-acting amylin analog. At Obesity Week in November 2023, Zealand presented results from Part 1 of the Phase 1b MAD trial (NCT05613387), in which low doses of up to 1.2 mg petrelintide administered once weekly for 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). Petrelintide was well tolerated in the trial with a mostly mild adverse event profile. In the first half of 2024, Zealand expects to report topline results from Part 2 of the MAD trial designed to evaluate higher doses of petrelintide administered for 16 weeks in participants with overweight or obesity (eligible BMI 27.0-39.9). In parallel, Zealand is planning a Phase 2b trial of petrelintide planned for initiation in the second half of 2024.
Dapiglutide, a first-in-class GLP-1/GLP-2 receptor dual agonist: In the first half of 2024, Zealand anticipates topline results from the Phase 2a investigator-led DREAM trial (NCT05788601) designed to evaluate the potential for weight loss following 12 weeks of treatment with dapiglutide and gain key mechanistic insights into effects on inflammatory markers. In the second half of 2024, Zealand expects topline results from the Phase 1b 13-week dose titration trial (NCT06000891) designed to evaluate dapiglutide in otherwise healthy participants with overweight or obesity (eligible BMI 27.0-39.9). In this trial, higher maximum maintenance doses are planned than were used in the prior 4-week MAD trial and ongoing DREAM trial.
Survodutide, a glucagon/GLP-1 receptor dual agonist. In February 2024, Boehringer Ingelheim and Zealand Pharma announced positive results from the Phase 2 trial of survodutide in metabolic dysfunction-associated steatohepatitis (MASH), previously known as nonalcoholic steatohepatitis (NASH). The topline results showed that up to 83.0% of adults treated with survodutide achieved a biopsy-proven improvement in MASH (stages F1, F2 and F3) after 48 weeks, versus 18.2% with placebo [response difference: 64.8% (CI 51.1% - 78.6%), p-value (p<0.0001)]. Boehringer expects to present these results at a scientific congress in the first half of 2024. In a Phase 2 trial in people living with overweight or obesity, survodutide achieved up to 18.7% mean weight loss from baseline after 46 weeks. The full data were presented at the 2023 American Diabetes Association's (ADA) 83rd Scientific Sessions. Boehringer is currently evaluating survodutide in Phase 3 clinical trials, including SYNCHRONIZE™-1 and SYNCHRONIZE™-2, enrolling people living with overweight or obesity without and with type 2 diabetes, respectively, and SYNCHRONIZE™-CVOT, a long-term cardiovascular safety trial in people living with overweight or obesity with cardiovascular disease, chronic kidney disease or with risk factors for cardiovascular disease.

Rare diseases - progressing towards patients

Dasiglucagon in congenital hyperinsulinism (CHI). In the first half of 2024, Zealand expects to resubmit the New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) for the prevention and treatment of hypoglycemia in pediatric patients seven days of age and older with CHI for up to three weeks of dosing. The resubmission is in response to a Complete Response Letter issued by the FDA in December 2023 related to deficiencies identified at a third-party manufacturing facility that are not specific to dasiglucagon. Also in the first half of 2024, to support use of dasiglucagon beyond three weeks, the company plans to submit additional analyses, requested by the FDA, from existing continuous glucose monitoring (CGM) datasets that were included as a secondary outcome measure in the Phase 3 program. Zealand plans to make dasiglucagon available to healthcare professionals and patients upon regulatory approval and expects to identify a partner for future commercialization.
Glepaglutide in short bowel syndrome (SBS). In December 2023, Zealand submitted an NDA to the U.S. FDA for the treatment of adult patients with SBS dependent on parenteral support. The company expects to receive notification of a PDUFA date in the coming weeks following acceptance of the filing. Zealand anticipates identifying a partner for future commercialization of glepaglutide.

Chronic inflammation - initiating first-in-human trials

ZP10068, Complement Inhibitor. As part of the discovery and development collaboration with Alexion, 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 expects to initiate first-in-human clinical trials in 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 for the full year 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.

The live listen-only audio webcast of the call and accompanying slide presentation will be accessible at https://edge.media-server.com/mmc/p/6jgd3v24. To receive telephone dial-in information and a unique personal access PIN, please register at https://register.vevent.com/register/BI7cc2120bbf334442986b5bd9d320475a. 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/.

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 associated annual report contain "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 Key Events Anticipated 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, patient recruitment 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 at third party manufacturers; dependency on third parties, for instance contract research or development organizations; 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 the ongoing military conflict in Ukraine and the uncertainty surrounding upcoming elections in the US. 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 company announcement and are based on information available to Zealand Pharma as of the date of this 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.

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



27/2 2024 07:31 ProInvestorNEWS 1118966



Zealand Pharma: Omsætningen blev tredoblet - fortsat stort underskud
27.2.2024 07.07 • MarketWire •

Zealand Pharma gik i 2023 frem på toplinjen, mens nettodriftsomkostningerne faldt.

På bundlinjen var der fortsat tale om et stort underskud for medicinalkoncernen, der i slutningen af december 2023 blev en del af C25.

Zealand Pharma havde i 2023 en omsætning på 342,8 mio. kr. Det er en fremgang fra niveauet på 104,0 mio. kr. i 2022.

Nettodriftsomkostningerne bakkede i perioden til 895,9 mio. kr. Det var dermed som ventet af selskabet, der i sin prognose havde regnet med nettodriftsomkostninger i niveauet 800-900 mio. kr.

Året før havde Zealand Pharma omkostninger på den post for 941,1 mio. kr.

På bundlinjen var der fortsat tale om røde tal i 2023. Samlet tabte Zealand Pharma 703,7 mio. kr. efter skat. Det skal holdes op mod et nettounderskud på 1202,1 mio. kr. i 2022.

.\˙ MarketWire



27/2 2024 07:32 ProInvestorNEWS 1118967



Zealand Pharma FY: Venter større nettodriftsomkostninger i 2024
27.2.2024 07.08 • MarketWire •

Biotekselskabet Zealand Pharma venter i 2024 nettodriftsomkostninger i niveauet 1100-1200 mio. kr.

Det fremgår af selskabets årsregnskab for 2023.

I 2023 havde Zealand Pharma driftsomkostninger på samlet 896 mio. kr.

.\˙ MarketWire



27/2 2024 07:53 ProInvestorNEWS 1118968



Zealand Pharma FY: Tabel for årsregnskab
27.2.2024 07.12 • MarketWire •

Tabel over Zealand Pharmas årsregnskab for 2023:
Mio. kr. 2023 2022
Omsætning 342,8 104,0
Netto driftsomkostninger 895,9 941,1
Resultat af primær drift -572,2 -837,2
Resultat før skat -708,9 -972,0
Nettoresultat -703,7 -1202,1
Udbytte pr. aktie (kr.) 0 0

Zealand Pharmas forventninger til 2024:
Mio. kr. Ved FY 2023
Nettodriftsomkostninger 1100-1200

.\˙ MarketWire

Morten Frederik Heltoft



27/2 2024 08:22 ProInvestorNEWS 1118969



Zealand Pharma har masser i pipelinen i 2024

27/2 08:03

Zealand Pharma har netop gjort status for et begivenhedsrigt 2023, hvor omsætningen blev mere end tredoblet, mens underskuddet på bundlinjen blev reduceret. Dertil blev selskabet indlemmet i C25.

Medicinalkoncernen afventer i 2024 nyt fra flere af sine lægemiddelkandidater i pipelinen - ikke mindst fedmemidlerne Dapiglutid, Petrelintid og Survodutid.

Fra sidstnævnte blev der mandag offentliggjort opløftende studiedata om behandling af fedtlever. På dagen sendte det aktien op med over 35 pct.

Her er et overblik over Zealand Pharmas årsregnskab:

* Zealand Pharma venter i 2024 nettodriftsomkostninger på 1100-1200 mio. kr. I 2023 havde selskabet omkostninger for 895,9 mio. kr. på den post.

* Medicinalkoncernen vil i 2024 fokusere på at maksimere værdien af sin pipeline.

* I 2024 afventer Zealand nye data fra studier med flere af sine midler, heriblandt fase 3-studiet Synchronize 1 og 2 med fedmemidlet Survodutid.

* Zealand Pharma søger aktivt kommercielle partnerskaber til sine midler Dasiglucagon mod hyperinsulinisme og Glepaglutid til behandling af korttarmssyndrom.

* Omsætningen blev i 2023 mere end tredoblet til 342,8 mio. kr. fra 104,0 mio. kr. året før.

* Underskuddet efter skat blev nedbragt til 703,7 mio. kr. fra 1202,1 mio. kr. i 2022.

Tabel over Zealand Pharmas årsregnskab for 2023:
Mio. kr.
2023
2022
Omsætning
342,8 104,0
Netto driftsomkostninger
895,9 941,1
Resultat af primær drift
-572,2
-837,2
Resultat før skat
-708,9 -972,0
Nettoresultat
-703,7 -1202,1
Udbytte pr. aktie (kr.)
0
0

Zealand Pharmas forventninger til 2024:
Mio. kr.
Ved FY 2023
Nettodriftsomkostninger
1100-1200

.\˙ MarketWire



27/2 2024 08:35 Munchi 1118970



er det kun mig der undrer mig over at alle medier og Zeal selv kalder det MASH når det hedder NASH ?



27/2 2024 08:54 Munchi 0118972



ok har fundet det.. det kan hedde begge dele NASH er den gamle betegnelse



27/2 2024 09:50 ProInvestorNEWS 1118973



Zealand Pharma/CEO: Flashoverblik fra interview
27.2.2024 09.03 • MarketWire •

Zealand Pharma er tirsdag kommet med regnskab for fjerde kvartal af 2023. Her er et overblik over flash med topchef Adam Steensberg:

ZEALAND PHARMA/CEO: HØJERE DRIFTSOMKOSTNINGER I 2024 SKAL FINANSIERE STUDIER

ZEALAND PHARMA/CEO: MILEPÆLSBETALING FRA BOEHRINGER BIDROG TIL TOPLINJEVÆKST

ZEALAND PHARMA/CEO: FREMHÆVER PETRELINTID SOM ALTERNATIV TIL GLP-1-PRODUKTER

ZEALAND PHARMA/CEO: AFVENTER 16-UGERS STUDIE EFTER VÆGTTAB PÅ 5% EFTER 6 UGER

ZEALAND PHARMA/CEO: INGEN TVIVL OM AT FOKUS ER PÅ FEDME NU

ZEALAND PHARMA/CEO: VENTER REGULATORISKE BESLUTNINGER FRA USA OM DASIGLUCAGON OG GLEPAGLUTID

ZEALAND PHARMA/CEO: HAR SAMTALER MED MULIGE PARTNERE OM KOMMERCIALISERING AF GLEPAGLUTID

ZEALAND PHARMA/CEO: HAR INGEN PLANER OM AT LADE SIG OPKØBE

ZEALAND PHARMA/CEO: SER SIG SELV SOM DEN RETTE TIL AT DRIVE VÆKSTEN

.\˙ MarketWire



TRÅDOVERSIGT