Company announcement - No. 26 / 2024
Zealand Pharma Announces Financial Results for the First Quarter of 2024
Strong performance in the first quarter of 2024 paving the way for important data read-outs across differentiated obesity assets in the second quarter.
Strong topline results announced in Boehringer Ingelheim Phase 2 clinical trial for survodutide in MASH
PDUFA date for glepaglutide in SBS set by US FDA for December 22, 2024
PDUFA date for dasiglucagon in CHI for up to three weeks of dosing (Part 1 of NDA) set by US FDA for October 8, 2024
Cash runway extended into 2027 through private placement of shares to institutional investors in January 2024 for gross proceeds of DKK 1.45 billion
Copenhagen, Denmark, May 16, 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 three months ended March 31, 2024, and provided a corporate update.
Strong start to eventful 2024
Adam Steensberg, President and Chief Executive Officer at Zealand Pharma said:
"I am very pleased with the continued advancement of our business in the first months of 2024. Our partner Boehringer Ingelheim reported impressive topline data from the Phase 2 trial with survodutide in MASH and recruitment into the Phase 3 trials in obesity is progressing very well. With our pipeline of wholly owned and differentiated obesity candidates, I am truly excited about the upcoming data read-outs for petrelintide and dapiglutide. In rare diseases, we have potential approvals in the US later in the year for both glepaglutide in short bowel syndrome and dasiglucagon in congenital hyperinsulinism. Backed by a solid financial position, we will continue to invest in our R&D programs, including preparations for comprehensive Phase 2b trials with our differentiated obesity candidates."
Key financial results for Q1 2024
DKK million Q1 2024 Q1 2023
Revenue 15.1 13.6
Net operating expenses1 -266.3 -182.3
Net operating result -255.8 -168.7
Net financial items 25.8 -26.7
DKK million Mar-31, 2024 Mar-31, 2023
Cash position2 3,234.8 1,633.1
Funding available incl. undrawn committed RCF3 3,584.8 1,983.1
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, as well as Tranche A of EIB loan disbursed in Q1 2024.
3. RCF = Revolving Credit Facility provided by Danske Bank.
Highlights in the first quarter 2024
Obesity and MASH
Survodutide, a glucagon/GLP-1 receptor dual agonist: Boehringer Ingelheim announced positive results from Phase 2 trial in MASH. The topline results showed that up to 83.0% of adults treated with survodutide achieved a biopsy-proven improvement in metabolic dysfunction-associated steatohepatitis (MASH) after 48 weeks without worsening of fibrosis stages F1, F2 and F3 (mild to moderate or advanced scarring), versus 18.2% with placebo. Survodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis. These results will be presented at the European Association for the Study of the Liver (EASL) congress in Milan, Italy on June 7, 2024.
Rare diseases
Glepaglutide, GLP-2 analog: US FDA has granted a Prescription Drug User Fee Act (PDUFA) date of December 22, 2024. Zealand's new drug application (NDA) is for glepaglutide administered twice weekly for the treatment of short bowel syndrome (SBS) with intestinal failure.
Financial
Solid financial position. Directed share issue of 3,761,740 new shares to two reputable institutional investors through a private placement for gross proceeds of DKK 1.45 billion, extending the cash runway into 2027. Tranche A of the EUR 90 million loan facility with the European Investment Bank (EIB), representing EUR 50 million, was disbursed and made available to Zealand in March 2024.
Events after the reporting date
Rare diseases
Dasiglucagon (CHI): US FDA has granted a PDUFA date of October 8, 2024 for dasiglucagon in CHI for up to three weeks of dosing (Part 1 of NDA). The regulatory review is being conducted in two parts under the same NDA. Part 1 relates to dosing of up to three weeks, whereas Part 2 relates to use beyond three weeks. Supporting the review of Part 2, the US FDA has requested additional analyses from existing continuous glucose monitoring (CGM) datasets that were included as a secondary outcome measure in the Phase 3 program. Submission of Part 2 of the NDA is moved into the second half of 2024.
Chronic Inflammation
ZP10068, Complement C3 Inhibitor: Alexion has discontinued development of ZP10068 citing business reasons and plans to return the pre-clinical asset to Zealand.
Upcoming events in 2024
Obesity
Petrelintide, amylin analog. In the second quarter of 2024, Zealand expects to report topline results from Part 2 of the multiple ascending dose (MAD) trial that is evaluating petrelintide 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.
Dapiglutide, a GLP-1/GLP-2 receptor dual agonist. In the second quarter of 2024, Zealand anticipates topline results from the 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, evaluating higher doses of dapiglutide compared to the prior 4-week MAD trial and the investigator-led DREAM trial.
Survodutide in MASH. Boehringer Ingelheim will present results from the Phase 2 trial with survodutide in MASH at the EASL congress in Milan, Italy on June 7, 2024.
Rare diseases
Glepaglutide in SBS. In parallel with the regulatory review process, Zealand is engaging in partnership discussions for future commercialization.
Dasiglucagon in CHI. 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 (Part 1 of NDA).
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
Guidance unchanged from February 27, 2024
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 expenses4 1,100-1,200 896
Notes:
4. Financial guidance based on foreign exchange rates as of May 16, 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 three 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.
Contacts:
Adam Lange
Investor Relations Officer
Zealand Pharma
Email: [email protected]
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
Email: [email protected]
Zealand Pharma Announces Financial Results for the First Quarter of 2024
Strong performance in the first quarter of 2024 paving the way for important data read-outs across differentiated obesity assets in the second quarter.
Strong topline results announced in Boehringer Ingelheim Phase 2 clinical trial for survodutide in MASH
PDUFA date for glepaglutide in SBS set by US FDA for December 22, 2024
PDUFA date for dasiglucagon in CHI for up to three weeks of dosing (Part 1 of NDA) set by US FDA for October 8, 2024
Cash runway extended into 2027 through private placement of shares to institutional investors in January 2024 for gross proceeds of DKK 1.45 billion
Copenhagen, Denmark, May 16, 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 three months ended March 31, 2024, and provided a corporate update.
Strong start to eventful 2024
Adam Steensberg, President and Chief Executive Officer at Zealand Pharma said:
"I am very pleased with the continued advancement of our business in the first months of 2024. Our partner Boehringer Ingelheim reported impressive topline data from the Phase 2 trial with survodutide in MASH and recruitment into the Phase 3 trials in obesity is progressing very well. With our pipeline of wholly owned and differentiated obesity candidates, I am truly excited about the upcoming data read-outs for petrelintide and dapiglutide. In rare diseases, we have potential approvals in the US later in the year for both glepaglutide in short bowel syndrome and dasiglucagon in congenital hyperinsulinism. Backed by a solid financial position, we will continue to invest in our R&D programs, including preparations for comprehensive Phase 2b trials with our differentiated obesity candidates."
Key financial results for Q1 2024
DKK million Q1 2024 Q1 2023
Revenue 15.1 13.6
Net operating expenses1 -266.3 -182.3
Net operating result -255.8 -168.7
Net financial items 25.8 -26.7
DKK million Mar-31, 2024 Mar-31, 2023
Cash position2 3,234.8 1,633.1
Funding available incl. undrawn committed RCF3 3,584.8 1,983.1
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, as well as Tranche A of EIB loan disbursed in Q1 2024.
3. RCF = Revolving Credit Facility provided by Danske Bank.
Highlights in the first quarter 2024
Obesity and MASH
Survodutide, a glucagon/GLP-1 receptor dual agonist: Boehringer Ingelheim announced positive results from Phase 2 trial in MASH. The topline results showed that up to 83.0% of adults treated with survodutide achieved a biopsy-proven improvement in metabolic dysfunction-associated steatohepatitis (MASH) after 48 weeks without worsening of fibrosis stages F1, F2 and F3 (mild to moderate or advanced scarring), versus 18.2% with placebo. Survodutide also met all secondary endpoints, including a statistically significant improvement in liver fibrosis. These results will be presented at the European Association for the Study of the Liver (EASL) congress in Milan, Italy on June 7, 2024.
Rare diseases
Glepaglutide, GLP-2 analog: US FDA has granted a Prescription Drug User Fee Act (PDUFA) date of December 22, 2024. Zealand's new drug application (NDA) is for glepaglutide administered twice weekly for the treatment of short bowel syndrome (SBS) with intestinal failure.
Financial
Solid financial position. Directed share issue of 3,761,740 new shares to two reputable institutional investors through a private placement for gross proceeds of DKK 1.45 billion, extending the cash runway into 2027. Tranche A of the EUR 90 million loan facility with the European Investment Bank (EIB), representing EUR 50 million, was disbursed and made available to Zealand in March 2024.
Events after the reporting date
Rare diseases
Dasiglucagon (CHI): US FDA has granted a PDUFA date of October 8, 2024 for dasiglucagon in CHI for up to three weeks of dosing (Part 1 of NDA). The regulatory review is being conducted in two parts under the same NDA. Part 1 relates to dosing of up to three weeks, whereas Part 2 relates to use beyond three weeks. Supporting the review of Part 2, the US FDA has requested additional analyses from existing continuous glucose monitoring (CGM) datasets that were included as a secondary outcome measure in the Phase 3 program. Submission of Part 2 of the NDA is moved into the second half of 2024.
Chronic Inflammation
ZP10068, Complement C3 Inhibitor: Alexion has discontinued development of ZP10068 citing business reasons and plans to return the pre-clinical asset to Zealand.
Upcoming events in 2024
Obesity
Petrelintide, amylin analog. In the second quarter of 2024, Zealand expects to report topline results from Part 2 of the multiple ascending dose (MAD) trial that is evaluating petrelintide 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.
Dapiglutide, a GLP-1/GLP-2 receptor dual agonist. In the second quarter of 2024, Zealand anticipates topline results from the 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, evaluating higher doses of dapiglutide compared to the prior 4-week MAD trial and the investigator-led DREAM trial.
Survodutide in MASH. Boehringer Ingelheim will present results from the Phase 2 trial with survodutide in MASH at the EASL congress in Milan, Italy on June 7, 2024.
Rare diseases
Glepaglutide in SBS. In parallel with the regulatory review process, Zealand is engaging in partnership discussions for future commercialization.
Dasiglucagon in CHI. 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 (Part 1 of NDA).
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
Guidance unchanged from February 27, 2024
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 expenses4 1,100-1,200 896
Notes:
4. Financial guidance based on foreign exchange rates as of May 16, 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 three 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.
Contacts:
Adam Lange
Investor Relations Officer
Zealand Pharma
Email: [email protected]
Anna Krassowska, PhD
Vice President, Investor Relations & Corporate Communications
Zealand Pharma
Email: [email protected]
16/5 2024 06:57 ProInvestorNEWS 0
120453 Zealand Pharma Q1: Omsætning og omkostninger vokser
i dag kl. 07:11 ∙ MarketWire
Zealand Pharma gik i første kvartal af 2024 frem på toplinjen, mens omkostningerne voksede.
På bundlinjen var der fortsat tale om et stort underskud for medicinalkoncernen, der i december 2023 blev indlemmet i C25-indekset.
Zealand Pharma havde i årets tre første måneder en omsætning på 15,1 mio. kr. Det er en fremgang fra niveauet på 13,6 mio. kr. i de tilsvarende måneder af 2023.
Nettodriftsomkostningerne steg i perioden til 266,3 mio. kr. Det var lidt mere end analytikerne havde ventet, da de estimerede 243,7 mio. kr. ifølge Bloomberg News.
I samme kvartal året før havde Zealand Pharma omkostninger på den post for 182,3 mio. kr.
Underskuddet før skat landede på minus 230,0 mio. kr., mens selskabet i første kvartal af 2023 tabte 195,3 mio. kr. før skat.
.\˙ MarketWire
i dag kl. 07:11 ∙ MarketWire
Zealand Pharma gik i første kvartal af 2024 frem på toplinjen, mens omkostningerne voksede.
På bundlinjen var der fortsat tale om et stort underskud for medicinalkoncernen, der i december 2023 blev indlemmet i C25-indekset.
Zealand Pharma havde i årets tre første måneder en omsætning på 15,1 mio. kr. Det er en fremgang fra niveauet på 13,6 mio. kr. i de tilsvarende måneder af 2023.
Nettodriftsomkostningerne steg i perioden til 266,3 mio. kr. Det var lidt mere end analytikerne havde ventet, da de estimerede 243,7 mio. kr. ifølge Bloomberg News.
I samme kvartal året før havde Zealand Pharma omkostninger på den post for 182,3 mio. kr.
Underskuddet før skat landede på minus 230,0 mio. kr., mens selskabet i første kvartal af 2023 tabte 195,3 mio. kr. før skat.
.\˙ MarketWire
16/5 2024 06:57 ProInvestorNEWS 0120454 Zealand Pharma Q1: Fastholder forventningerne til 2024
i dag kl. 07:00 ∙ MarketWire
Zealand Pharma fastholder forventningerne til regnskabsåret 2024 om nettodriftsomkostninger i niveauet 1100-1200 mio. kr.
Det fremgår af biotekselskabets regnskab for første kvartal af 2024.
.\˙ MarketWire
i dag kl. 07:00 ∙ MarketWire
Zealand Pharma fastholder forventningerne til regnskabsåret 2024 om nettodriftsomkostninger i niveauet 1100-1200 mio. kr.
Det fremgår af biotekselskabets regnskab for første kvartal af 2024.
.\˙ MarketWire
16/5 2024 08:37 EliotSpitzer 2120457 Rgenskabet har lidt negative nyheter, bl.a. at Alexion samarbejdet ophører men den overordnet case er fortsat intakt og postivt på lang sigt, hvis blot de leverer på det som de stiller i udsigt.
16/5 2024 09:53 troldmanden 2120465 Alt der ikke rimer på fedme er mere eller mindre end parentes for ZP.
Det lyder hårdt da de også har meget andet i pipelinen. Men det er fedme stofferne der vægter og dirigere kursen afhængig hvilke nyhedsflow der er fra dem selv og andre relaterede selskaber.
Vi venter alle på amy fase 1b
Det lyder hårdt da de også har meget andet i pipelinen. Men det er fedme stofferne der vægter og dirigere kursen afhængig hvilke nyhedsflow der er fra dem selv og andre relaterede selskaber.
Vi venter alle på amy fase 1b
