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ZEAL - Financial Results for the First Nine Months 2022


107722 Helge Larsen/PI-redaktør 10/11 2022 15:13
Oversigt

Company announcement No. 51 / 2022

Zealand Pharma Announces Financial Results for the First Nine Months of 2022

Copenhagen, Denmark November 10, 2022 - 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 and nine months ended September 30, 2022 and provided a corporate update.

Key strategic objectives achieved

Adam Steensberg, President and Chief Executive at Zealand Pharma said: "Zealand has continued to execute and deliver on key objectives in the third quarter. In September, we completed our stated objective of securing partnerships for our marketed products through a license and development agreement with Novo Nordisk, a global leader in diabetes, to commercialize Zegalogue®.

"Within our R&D pipeline of investigational therapeutic peptides we have seen further positive clinical data. In September we reported topline results from the Phase 3 EASE-1 trial showing that treatment of short bowel syndrome patients with twice weekly glepaglutide, our long-acting GLP-2 analogue, resulted in a statistically significant 5.13 liters/week reduction from baseline in the volume of parenteral support required. Importantly, approximately 1 in 8 patients treated with glepaglutide weaned off parenteral support within 24 weeks, while no placebo treated patients were able to wean off parenteral support, which we believe is differentiating from current treatments. We look forward to seeing the results of the ongoing glepaglutide EASE-2 and 3 long term extension trials and engaging with the regulatory authorities in preparation for an NDA submission. In obesity, our partner Boehringer Ingelheim, presented Phase 2 data for the dual GCGR/GLP-1R agonist BI 456906 in patients with type 2 diabetes, showing encouraging glycemic control through a reduction in HbA1c, as well as body weight loss. We are encouraged by these results and look forward to seeing the results from Boehringer's ongoing Phase 2 trial in patients with obesity, which we expect next year. We also made progress with our own early-stage clinical candidates in obesity.

"Finally, we strengthened our balance sheet with gross proceeds of DKK 786 million from a directed issue and private placement resulting in an adjusted cash position of DKK 1,515 million in early October."

Financial results for the first nine months of 2022

Revenue: DKK 80.1 million (DKK 95.1 million in the first nine months of 2021).
Net operating expenses: DKK -675.7 million (DKK -652.8 million in the first nine months of 2021).
Net operating result: DKK -596.2 million (DKK -568.7 million in the first nine months of 2021).
Net financial items: DKK -53.4 million (DKK 21.5 million in the first nine months of 2021).
Net result from Discontinued Operations: DKK -215.1 million (DKK -193.7 million in the first nine months of 2021).
Cash, cash equivalents, and marketable securities: DKK 729.9 million as of September 30, 2022 (September 30, 2021: DKK 1,049.0 million).

Highlights in the third quarter 2022

Announced positive topline results from the pivotal Phase 3 EASE-1 trial of glepaglutide, a long-acting GLP-2 analogue designed for subcutaneous delivery via auto-injector, in patients with short bowel syndrome (SBS). Glepaglutide treatment met the primary endpoint with twice weekly dosing achieving a statistically significant reduction in weekly parenteral support volume by 5.13 Liters/week from baseline at 24 weeks. 66% of patients in the twice weekly group had a clinically meaningful response (>20% reduction in parenteral support volume). In total 9 of 70 patients treated with glepaglutide were weaned off parenteral support, while no placebo treated patients were able to wean off parenteral support. Glepaglutide treatment appeared to be safe and was well-tolerated in the trial.
Reported results from the Boehringer Ingelheim-sponsored Phase 2 clinical trial of BI 456906, a glucagon receptor/glucagon-like peptide-1 receptor (GCGR/GLP-1R) dual agonist, in patients with type 2 diabetes (T2D) at the 58th Annual Meeting of the European Association for the Study of Diabetes (EASD). Treatment with BI 456906 resulted in dose dependent HbA1c reductions, with a mean of up to -1.88% at Week 16 compared with -0.25% seen with placebo. Treatment with open-label weekly semaglutide at 1.0 mg led to a decrease in HbA1c of -1.47%. The safety and tolerability profile, which included gastrointestinal disorders (such as nausea and vomiting) as the most frequently reported adverse events, was as is expected with higher increasing doses of GLP-1 receptor agonists. Most adverse events were reported during the dose-escalation phase of the trial, and therefore slower escalation schemes may mitigate the frequency of such events.
Presented results from the Phase 3 clinical trial of dasiglucagon in congenital hyperinsulinism (CHI) at the 60th Annual Meeting of the European Society for Paediatric Endocrinology (ESPE). Dasiglucagon significantly reduced the requirement for intravenous glucose to maintain glycemia in newborns and infants with CHI (Part 1 of Phase 3 trial). Dasiglucagon reduced time in hypoglycemia and enabled discontinuation of intravenous glucose in most infants and limited the need for pancreatectomy (Part 2 of Phase 3 trial). Results support the potential for dasiglucagon to be a novel, effective, and well tolerated treatment for infants with CHI dependent on intravenous glucose.
Completed dose escalation in the ongoing Phase 1a single ascending dose (SAD) trial of ZP8396, a long-acting amylin analogue. In this Phase 1 SAD trial, subcutaneous ZP8396 appeared to be well tolerated with no unexpected side effects and the single administration maximum tolerated dose (MTD) was reached. The pharmacokinetic (PK) profile is suitable for once weekly dosing. Zealand expects to initiate dosing in a Phase 1b multiple ascending dose (MAD) trial of ZP8396 by the end of 2022.
Announced a global license and development agreement with Novo Nordisk to commercialize ZEGALOGUE® (dasiglucagon) for injection. Agreement includes an upfront payment, development, regulatory, manufacturing and sales-based milestones of up to DKK 290 million to Zealand in addition to high-single to low-double digit royalties on worldwide net sales by Novo Nordisk. Zealand will be responsible for certain planned development, regulatory, and manufacturing activities to support approval outside the U.S. to be reimbursed by Novo Nordisk.
Appointed Henriette Wennicke as Chief Financial Officer. Henriette Wennicke brings broad finance and business experience at large organizations, including in healthcare, where she has led financial planning, R&D portfolio management and investor relations.
Completed voluntary delisting of its American Depositary Shares (ADSs) from the New York-based Nasdaq Global Select Market. One ADS currently represents one ordinary share in Zealand and on suspension of trading the company's ADSs accounted for less than 1.5% of the total share capital. Trading in Zealand shares is consolidated to Nasdaq Copenhagen, the company's primary and most liquid stock exchange. The decision is part of Zealand's strategy to prioritize R&D and streamline corporate operations.

Events after the reporting date

Presented preclinical data at the Annual Meeting of the Obesity Society (Obesity Week) on Zealand's amylin analogue (ZP8396); its first-in-class GLP-1R/GLP-2R dual agonist (dapiglutide); and the GIP analogue (ZP6590).
Reported results from the Boehringer Ingelheim-sponsored Phase 2 clinical trial of BI 456906 (GCGR/GLP-1R) in patients with T2D at Obesity Week. BI 456906 resulted in dose-dependent bodyweight reductions of up to -9% at Week 16.
Phase 2 trial of BI 456906 in patients with non-alcoholic steatohepatitis (NASH) conducted by Boehringer Ingelheim has completed patient enrollment.
Received gross proceeds of DKK 786 million from a directed issue and private placement. Zealand issued a total of 4,975,000 new shares at a subscription price of DKK 158 per share.

Upcoming events

Initiate Phase 1b MAD trial of ZP8396, a long-acting amylin analogue in development for obesity by the end of the fourth quarter 2022.
Interim Phase 3 data from EASE-SBS 2 and 3 long term extension trials of glepaglutide expected by the end of the fourth quarter 2022, and first quarter of 2023, respectively.
Potential submission of new drug application (NDA) with the U.S. Food and Drug Administration (FDA) for dasiglucagon treatment in the management of CHI in the first half of 2023, based on data from the full Phase 3 program.

Financial guidance for 2022

The company will no longer provide guidance on net product revenue, reflecting the completion of the asset purchase agreement for V-Go® with MannKind Corporation and the completion of the global license and development agreement for Zegalogue® with Novo Nordisk.

In 2022, Zealand expects revenue from existing license agreements. However, since such revenue is uncertain in terms of size and timing, Zealand does not intend to provide guidance on such revenue.

Net operating expenses in 2022 are expected to be DKK 1,000 million +/-10%*. This is unchanged from our updated guidance issued on March 30, 2022.

*Excluding discontinued operations

Conference call today at 4 PM CET / 10 AM ET

Zealand's management will host a conference call today at 4 PM CET / 10 AM ET to present results through the first nine months of 2022 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.

Telephone dial-in information and a unique personal access PIN will be provided upon registration at https://register.vevent.com/register/BI2233344c2eff4f40be51448707df4e03. A live listen-only audio webcast of the call, including an accompanying slide presentation, will be accessible at https://edge.media-server.com/mmc/p/untoz3rk. 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-cal.

Total number of shares and voting rights in Zealand Pharma A/S as of September 30, 2022

Number of shares (nominal value of DKK 1 each): 46,538,186 which is an increase of 2,895,044 from 43,634,142 as reported on December 31, 2021.

Therefore, the current share capital is (nominal value in DKK): 46,538,186.

Number of voting rights: 46,538,186.

On October 4, 2022, The Group announced that a directed issue and private placement of 4,975,000 new shares had been completed. Please refer to note 17 for further information.



10/11 2022 18:14 ProInvestorNEWS 1107734



Zealand Pharma Q3: Omsætning dykker og underskud vokser

10/11 17:15

Biotekselskabet Zealand Pharma har set toplinjen vige og underskuddet stige i årets tredje kvartal, hvor selskabet fortsatte med at arbejde for den omstrukturering, der blev lanceret tilbage i marts.

Med omstrukturering har Zealand Pharma over de seneste måneder arbejdet for udelukkende at blive et forsknings- og udviklingsselskab, mens de tidligere havde både salgsorganisation og produkter, der skulle markedsføres.

Det indebærer, at flere produkter er blevet frasolgt, og har også udmøntet sig i nye sammenligningstal i det netop offentliggjorte regnskab.

Her endte omsætningen på 43,7 mio. kr. mod 54,2 mio. kr. i tredje kvartal året før.

Underskuddet efter skat faldt til 153,7 mio. kr. i tredje kvartal mod 142,4 mio. kr. i samme periode året før, viser de nye sammenligningstal.

Nettodriftsomkostningerne, som er det eneste tal, Zealand Pharma fortsat opgiver forventninger til, løb op i 205,2 mio. kr. fra 212,8 mio. kr. i samme periode af 2021.

Zealand Pharma fastholder forventningerne til regnskabsåret 2022 om nettodriftsomkostninger omkring 1000 mio. kr., mens selskabet har suspenderet forventningerne til produktsalget.

Tabel for Zealand Pharmas regnskab for tredje kvartal af 2022:

Mio. kr.
Q3 2022
Q3 2021*
FY 2021*
Omsætning
43,7
54,2
108,5
Nettodriftsomkostninger
-205,2
-212,8
-880,5
Heraf forsknings- og udviklingsomkostninger
-145,1
-139,5
-582,3
Resultat af primær drift
-162,1
-158,5
-784,3
Resultat før skat
-153,7
-142,4
-758,9

*Sammenligningstal og tal for hele 2021 er ændret efter frasalg.

Zealand Pharmas forventninger til 2022:

Mio kr.
Ved Q3 2022
Før Q3 2022
Nettodriftsomkostninger
1000
1000

.\˙ MarketWire



11/11 2022 14:04 EliotSpitzer 2107755



En af de ting som jeg gerne vil se noget information på var følgende: "Interim Phase 3 data from EASE-SBS 2 and 3 long term extension trials of glepaglutide expected by the end of the fourth quarter 2022, and first quarter of 2023, respectively.". Resultaterne for EASE-SBS 2 tror jeg bliver meget afgørende. Hvis de bare er nogenlunde på line med EASE 1 så har ZP en helt utrolig god klinisk historie.

Jeg har også været nysgerrig på om pengene fra Protagonist Therapeutics er kommet ind. Der var strid om kontrakten sidste år men der blev indgået et jurdisk forlig, hvor det bl.a blev enighed om at "Protagonist will also make a $1.5 million payment to Zealand in August 2022". Dette må vel tælle som en del av "Revenue: DKK 80.1 million (DKK 95.1 million in the first nine months of 2021).".



12/11 2022 13:41 exitnu 1107774



Zealand Pharma A/S (ZEAL) Q3 2022 Earnings Conference Call November 10, 2022 10:00 AM ET

https://seekingalpha.com/article/4556638-zealand-pharma-s-zeal-q3-2022-earnings-call-transcript

Company Participants

Anna Krassowska - Vice President, Investor Relations & Corporate Communications

Adam Steensberg - President & Chief Executive Officer

Henriette Wennicke - Chief Financial Officer

David Kendall - Chief Medical Officer

Conference Call Participants

Joseph Stringer - Needham & Company

Brian Balchin - Jefferies



15/11 2022 15:29 EliotSpitzer 1107880



Det virker som om der var problemer med telefonen hos opreator. Vanlig så er der altid mere end to analytiker med på disse calls.



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