Company announcement - No. The iLet® bionic pancreas intends to mimic a biological pancreas by calculating and dosing insulin and/or glucagon (dasiglucagon) as needed, based on input data from a continuous glucose monitor (CGM) worn by a person with diabetes. 2 Russell, S. et al. Mens virksomhederne til stadighed leder efter nye markedsområder, der kan indtages, ligger den offentlige sektor som den største og mest stabile enkeltsektor nærmest uudnyttet hen. The impact of COVID-19 on our research activities has thus far been minimal. The increase in cash used in operating activities from the same period in 2020 is mainly related to our sales and marketing and administrative expenses increasing as a result of the commercial activities and support for Zegalogue and the V-Go wearable insulin delivery device. Vi har tidligere haft for vane at tage samme aktie med flere år i træk på listen med Life … Life Science. At Obesity Week in November this year Boehringer Ingelheim presented data from the Phase 1b trial, demonstrating up to 13.7% weight loss and no unexpected safety findings following 16 weeks of dosing. De fuldstændige vilkår for warrants er vedlagt som bilag 8.4.n. Generelt Af Marketwire. In particular, the global COVID-19 pandemic could potentially materially adversely impact our business and financial performance, including the timing of our clinical trials, projected regulatory approval timelines, our supply chain and sales of our approved products, as well as our Financial Guidance for 2021 in this interim report, particularly because the COVID-19 pandemic continues to evolve, and its breadth and significance on our business and financial performance is uncertain. (1) Zealand expects to be eligible to receive up to DKK 5.5 million in Danish corporate tax benefit related to R&D expenses incurred for 2021, of which DKK 4.1 million has been recognized for the period ended September 30, 2021, which is setoff against expected tax expense in the US. On page 17, section 8.4 – the articles have been amended to reflect the changes (this change has also been amended to the belonging exhibit 8.4.l): 5. På Placera och Avanza använder vi cookies för att säkerställa funktionalitet, personalisera innehåll och annonser och för att analysera hur sajten används. 110-140: GomSpace* 04-05-2021: Kurs 15,2 SEK: Kursmål 0-6 mrdr. The increase in sales and marketing expenses is related to efforts for the Zegalogue launch as well as continued commercial support for the V-Go wearable insulin delivery device. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Press Release reported on 08/20/21 that Zealand Pharma increases its share capital 1 Castellanos, L.E. The condensed interim financial statements are prepared in accordance with IAS 34 Interim Financial Reporting, as issued by the International Accounting Standards Board (IASB) and as adopted by the EU, and additional requirements of the Danish Financial Statements Act. Zealand Pharma, Zealand Pharma increases its share capital as a consequence of exercise of employee warrants. Zegalogue is available in both an auto injector and a prefilled syringe. Glepaglutide is a long-acting GLP-2 analog, being developed in an auto-injector with potential for convenient weekly administration for reducing or eliminating the need for parenteral support in people living with SBS. Zealand Pharma plans to publish results for the fourth quarter of 2021 on March 10, 2022. The net income tax (income) is mainly impacted by the tax deduction in Denmark, a prior period correction offset by tax expenses in US. As of September 30, 2021, and December 31, 2020, the following financial instruments are measured at fair value through profit or loss: The fair value of marketable securities and other investments is based on Level 1 and Level 3, respectively, in the fair value hierarchy. Schedule 8.4.e constitutes an integrated part of these Articles of Association. Som følge af dels udnyttelse, dels bortfald af warrants, er det udestående antal warrants, der kan udnyttes, reduceret til 302.142 warrants. Danish biotechnology company Zealand Pharma has leased 10,600 square feet at 44 Farnsworth St. in Boston for its U.S. headquarters. SA Transcripts. The complaint alleges federal and state law claims, including claims for breach of confidentiality agreements, trade secret misappropriation and unfair competition. The final number of warrants granted is 283,250. Since approval, Zealand Pharma has made substantial progress working with Pharmacy Benefit Managers (PBMs), Managed Care Organizations, and state Medicaid agencies to add Zegalogue to their respective formularies. We expect to complete enrolment into the 17103 trial by the end of 2021 and have results in the first half of 2022. Zealand Pharma* 19-05-2021: Kurs 186: Kursmål 0-6 mdr. However, we have not recognized any write-offs, impairments of assets, or losses to onerous contracts due to COVID-19. 30 70 02 28, Interim condensed consolidated financial statements. The bihomonal iLet® bionic pancreas performance will also be compared to intensified usual care using CGM therapy in a third arm in both the pediatric and adult RCTs. The new shares will be listed on Nasdaq Copenhagen after registration of the capital increase with the Danish Business Authority. The increase is a consequence of the exercise of warrants granted under several of Zealand Pharma's employee warrant programs. Ingelheim, Germany and Copenhagen, Denmark, 2 June, 2021 - Boehringer Ingelheim and Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. Further in June and July 2021, the Company acquired owns shares through a share buyback program. Schedule 8.4.l constitutes an integrated part of these Articles of Association. Since the 12 months period has expired all amounts are assessed to be final and no further adjustments relating to the business combination can occur. Secondary objectives are to assess the effect on change in body weight and an open-label comparator (semaglutide) will allow for comparison of the effects against a pure GLP-1R agonist. As a result of exercise/lapse of warrants, the number of warrants available for exercise has been reduced to 302,142 warrants. A review of the interim condensed consolidated financial statements in accordance with the International Standard on Review of Interim Financial Information Performed by the Independent Auditor of the Entity is a limited assurance engagement. 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. Zealand Pharma increases its share capital as a consequence of exercise of employee warrants. All such forward-looking statements speak only as of the date of this release and are based on information available to Zealand Pharma as of the date of this release. Our responsibility is to express a conclusion on the interim condensed consolidated financial statements. The complete terms of the warrants are attached as Schedule 8.4.i. 17,263 warrants were exercised on 15 April 2020, 38,121 warrants were exercised on 26 May 2020, 14,495 warrants were exercised on 12 June 2020, 8,050 warrants were exercised on 21 August 2020, 2,976 warrants were exercised on 11 September 2020, 11,495 warrants were exercised on 20 November 2020, 3,250 warrants were exercised on 11 December 2020, 3,770 warrants were exercised on 19 March 2021, 3,900 warrants were exercised on 9 April 2021, 2,000 warrants were exercised on 20 May 2021, 4,395 warrants were exercised on 10 June 2021, 1,854 warrants were exercised on 20 August 2021, and 8,089 warrants were exercised on 10 September 2021. Cash used in investing activities in the first nine months of 2021 related mainly to acquisition of tangible assets. 20 04 50 78), a Copenhagen-based biotechnology company focused on the discovery and development of innovative peptide-based medicines, announces the following dates for the company's planned financial reporting in 2021. Muligheden for at FDA kunne finde på at ønske yderligere . Zealand Pharma continues to monitor the COVID-19 pandemic and take precautions to keep our employees, patients, business and clinical partners safe. Christophe Weber calls Takeda 'a tech biopharmaceutical company' 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. Zealand Pharma has only one class of shares. A few amendments apply for the first time in 2021, but do not have an impact on the interim condensed consolidated financial statements of the Group. Hospital Medicines (HML) Toggle child menu. Cash from financing activities increased primarily because of the January 2021 financing with an aggregate gross amount of DKK 748.9 million. "New Zealand needs to continue to contribute to the global effort to develop Covid-19 vaccines. Udviklingsdirektøren har torsdag solgt 20.000 aktier til 206,59 kr. fredag 15. januar 2021 2 bud på danske 2021-vindere og en lille håndfuld outsidere. 131.900 warrants udstedt under dette program er pr. Generelt Af Marketwire. All funded medicines in New Zealand. Each volume treats a well defined family with text in Danish, but with numerous illustrations that make the volumes valuable also for non-Danish readers. Interim condensed consolidated income statement for the three- and nine-month periods ended September 30, 2021 and 2020. Skønne kager og søde sager er rigt illustreret med smukke billeder og Simone Thorups fine streg. Bogen udkommer i samarbejde med ChriChri Journal. Dette er en ebog med såkaldt fixed layout. Dapiglutide (pINN) is a long-acting GLP-1R/GLP-2R dual agonist. Revenue is the top line item on an income statement from which all costs and expenses are subtracted to arrive at net income. More than 10 drug candidates invented by Zealand have advanced into clinical development, of which two have reached the market. Zealand Pharma Hosts Conference Call on November 11 at 4 pm CET (10 am ET) to Present Third Quarter Results for 2021. Substantial US operations were acquired in April 2020 following the close of the Valeritas asset purchase agreement. Information concerning pharmaceuticals (including compounds under development) contained within this material is not intended as advertising or medical advice. No financial assets are based on Level 2. Other payables comprise of payables to authorities etc. License and milestone revenue for the first nine months of 2021 is DKK 95.2 million of which DKK 30.7 million is related to the Sanofi agreement. You should not place undue reliance on these statements, or the scientific data presented. Participants will receive a subcutaneous injection of either BI 456906 or placebo once a week for the duration of the trial. Diabetes Care, 44:e118–e120. 550-625: Netcompany* 11-05-2021: Kurs 645: Kursmål 0-6 mdr. Det konkrete antal warrants tildelt udgør 220.764. Vi har tidligere haft for vane at tage samme aktie med flere år i træk på listen med Life … Life Science. New standards, interpretations and amendments adopted by the Group. 62 / 2021. til 208,20 kr. Det konkrete antal warrants tildelt udgør 515.500. We have continued our clinical trials while working with authorities, investigators, trial sites and contract research organizations to minimize site visits and ensure optimal trial follow-up. 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 integrate operate businesses in varying geographies; 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; and the direct and indirect impacts of the ongoing COVID-19 pandemic on our business, results of operations and financial condition. 10. september 2021 bortfaldet. Zealand Pharma A/S (NASDAQ:ZEAL) went up by 1.69% from its latest closing price compared to the recent 1-year high of $44.42. I Ledelsesbaseret coaching giver forfatterne indgående beskrivelser af coachingværktøjer og omsætter dem til en ledelsesmæssig kontekst. Glepaglutide for short bowel syndrome (SBS). The new shares give rights to dividend and other rights from the time of the warrant holder's exercise notice. per aktie. Copenhagen, DK and Boston, MA, U.S. September 9, 2021 - Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. Zealand Pharma revenue from 2017 to 2021. In the preparation of the interim condensed consolidated financial statements, the Company’s management (“Management”) makes several accounting estimates that form the basis for the presentation, recognition and measurement of the Company’s assets and liabilities. The complaint alleges claims against Zealand Pharma A/S (and its U.S. subsidiary) and its collaboration partner Alexion Pharmaceuticals, Inc. (“Alexion”) related to Zealand Pharma A/S’s collaboration with Alexion on C3 peptide-based assets. Net product revenue from the sales of commercial products is expected to be DKK 190 million +/- 10%. The decrease in Prepaid expenses from DKK 48.3 million at December 31, 2020 to DKK 41.0 million at September 30, 2021 is mainly relating to timing differences. Schedule 8.4.0 constitutes an integrated part of these Articles of Association. Measurement is considered a level 3 measurement. The product revenue from sale of goods of DKK 104.0 million in the table above is driven by activity for the six-month period April 2,2020 to September 30, 2020, following the Valeritas acquisition on April 2, 2020. 35/ 2021 Boehringer Ingelheim and Zealand Pharma Receive FDA Fast Track Designation for Investigational Treatment for NASH o FDA's Fast Track Designation for the GLP . Copenhagen, DK and Boston, MA, U.S. June 29, 2021 - Zealand Pharma A/S (Nasdaq: ZEAL) (CVR-no. and has now fallen 3 days in a row.During the day the stock fluctuated 5.72% from a day low at $24.28 to a day high of $25.67.The price has fallen in 5 of the last 10 days and is down by -22.19% for this period. The net sales comprise of gross sales of DKK 270.3 million and discounts and rebates of DKK -127.0 million. 64 / 2021. The COVID-19 pandemic may, in the long-term, affect the productivity of our staff; our ability to attract, integrate, manage and retain qualified personnel or key employees; our global supply chains and relationships with vendors and other parties; significant disruption of global financial markets; and reduced ability to secure additional funding. For the lead target, Zealand Pharma is eligible to receive up to USD 610 million in development and sales milestone payments, plus royalties on global sales in the high single to low double digits. The company's stock price has collected 5.72% of gains in the last five trading sessions. And players with unique skills, like Neil Wagner in Tests, a left-arm enforcer, or Kyle Jamieson, a beanpole who could swing the ball both ways. 11. nov 2021 KL.15:15. The primary endpoint of this trial is the percentage change in body weight at week 46 compared to placebo. The following changes have occurred in the share capital during the respective year-to-date interim periods: As part of the capital increase made in January 2021, a total of 200,000 shares were purchased through a share swap transaction. Before Zealand, Erin was at Pear Therapeutics, Inc., a digital health company, where she served as Assistant General Counsel. Out-patient Phase 2 trials in exercise-induced hypoglycemia in people living with type 1 diabetes and for people that suffer from meal-induced hypoglycemia following gastric bypass surgery were initiated in the second quarter this year (ClinicalTrials.gov Identifier: NCT04764968 and NCT04836273). The COVID-19 pandemic is also having an effect on other aspects of our business, including: our third-party manufacturers, and other third parties; albeit with no material effect or impact. I denne bog definerer Anders Raastrup Kristensen dette arbejdsliv med flydende grænser og peger på udfordringerne ved selvledelse. Fx hvor er grænsen mellem familie- og arbejdsliv? Hvordan skal arbejdsopgaven planlægges og bestemmes. 20045078), a biotechnology company focused on the discovery, development and commercialization of innovative peptide-based medicines, has increased its share capital by a nominal amount of DKK 30,748 divided into 30,748 new shares with a nominal value of DKK 1 each. 20045078,) a biotechnology company focused on the discovery, development and commercialization of innovative peptide-based medicines, today announced that members of its senior . 68 / 2021 Zealand Pharma to Participate in Jefferies London Healthcare Conference Copenhagen, DK and Boston, MA, U.S. November 12, 2021 - Zealand Pharma A/S (Nasdaq . ZP8396 is a potent long-acting amylin analogue designed to improve solubility and allow for co-formulation with other peptides, including GLP1 analogues. The lead program is a long-acting inhibitor of Complement C3 which has the potential to treat a broad range of complement mediated diseases. Hjernesmarte børn har brug for hjernesmarte voksne. Sale of goods revenue for the first nine months of 2021 of DKK 138.9 million related to V-Go and DKK 4.4 million related to Zegalogue. However, it is Management’s opinion that the amount of any payment cannot be determined on a sufficiently reliable basis, and therefore the company has not recognized an asset in the statement of financial position of the Group. In January, as the second Covid-19 wave hit the country, South Africa didn't have a single dose of the one biomedical intervention . The final number of warrants granted is 397,750. Other News. The decrease is primarily due to currency translation and amortization. 92.782 warrants udstedt under dette program er pr. Japanese Nobel laureate and Kyoto University professor Tasuku Honjo has sued Ono Pharmaceutical over the . The assumptions can be incomplete or inaccurate, and unexpected events or circumstances might occur. The estimates and underlying assumptions are reviewed on an ongoing basis. The participation of older adults is critical to help evaluate new vaccines for this population." Dr Frances Priddy https://lnkd.in/ghDhVkba. CVR no. (3) Free cash flow is calculated as the sum of cash flows from operating activities and purchase of property, plant and equipment. 04-11-2021. At a meeting of the board of directors of the Company held on 15 April 2020, the board of directors of the Company resolved to issue warrants (2020-3 employee incentive program) corresponding to a nominal amount of DKK 220,764 shares; and the board of directors at the same time resolved to increase the share capital of the Company in accordance therewith. Year-to-Date net revenue is DKK 4.3 million / USD $0.7 million. Revisions to accounting estimates are recognized in the period in which the estimate is revised if the revision affects only that period, or in the period of the revision and future periods if the revision affects both current and future periods. The decrease from DKK 85.0 million at December 31, 2020 to DKK 83.3 million as at September 30, 2021 is primarily related to depreciations in the period, partially offset by an increase in assets under construction in Denmark. This is an ongoing exercise in monitoring the effects of the pandemic on all of our key stakeholders and responding appropriately. Aug. 12, 2021 11:21 AM ET Zealand Pharma A/S (ZEAL), ZLDPF 1 Like. The pandemic impacted the speed of patient recruitment for our Phase 3 trial with glepaglutide for the treatment of short bowel syndrome, and results are expected in 2022. On page 2, section 4.1 – the Articles have been amended to reflect the new share capital. Zegalogue (dasiglucagon) injection was approved by the U.S. FDA on March 22, 2021 for the treatment of severe hypoglycemia in people with diabetes aged 6 and over. Zealand's robust pipeline of investigational medicines includes three candidates in late stage . Management's responsibilities for the interim condensed consolidated financial statements Copenhagen, DK and Boston, MA, U.S. November 12, 2021 - Zealand Pharma A/S (NASDAQ . Zealand Pharma Announces Presentation of Preclinical Data on Amylin Analogue, ZP8396, and Clinical Data on Glucagon-GLP1 Dual-Agonist, BI 456906, at The . Zealand Pharma A/S (ZEAL) CEO Emmanuel Dulac on Q3 2021 Results - Earnings Call Transcript: Do: Zealand Pharma reports Q3 results: Do: Zealand Pharma 9-Month Operating Result DKK -762.6 Million vs . 10. september 2021 bortfaldet. Performance of the bihormonal iLet bionic pancreas with the stable glucagon analog dasiglucagon. 8,659 warrants were exercised on 21 August 2020, and 8,659 warrants were exercised on 10 September 2021. Company announcement - No. The potential for chronic dasiglucagon infusion delivered via a pump to prevent hypoglycemia in children with CHI is being evaluated in a Phase 3 program. Number of shares (nominal value of DKK 1 each): 43,581,697 which is an increase of 39,859 from 43,428,192 as of June 30, 2021. Copenhagen, DK and Boston, MA, September 30, 2021 - Zealand Pharma A/S ("Zealand") (NASDAQ: ZEAL) (CVR-no. Participants are advised to register for the webcast approximately 10 minutes before the start. I øjeblikket ligger Zealand Pharma-kursen på omkring 215,6 og den er steget med 145,56 procent over det sidste år. Zealand Pharma increases its share capital as a consequence of exercise of employee warrants Your publication date and time will appear here. But they have men who perform their roles to their optimal capacity. Zealand Pharma Hosts Conference Call on August 12 at 4 pm CET (10am ET) to Present Second Quarter Results for 2021. To the shareholders of Zealand Pharma A/S. The auditor performs procedures primarily consisting of making enquiries of Management and others within the company, as appropriate, applying analytical procedures and evaluate the evidence obtained. Under the terms of the agreement, Alexion and Zealand Pharma entered into an exclusive collaboration for the discovery and development of subcutaneously delivered peptide therapies directed to up to four complement pathway targets. Toggle child menu. Company announcement - No. The tax amount recognized in 2021 includes tax income of DKK 4.1 million relating to corporate tax benefit in Denmark, a correction in US to prior periods of DKK 7.3 million offset by tax expenses in US of DKK 8.2 million. The share capital of the Company is DKK 43,581,697. Company announcement - No. EY The complete terms of the warrants are attached as Schedule 8.4.e. 11.638 warrants udstedt under dette program er pr. Schedule 8.4.i constitutes an integrated part of these Articles of Association. On page 13 and 14, section 8.4 – the articles have been amended to reflect the changes (this change has also been amended to the belonging exhibit 8.4.e): 3. The estimates and associated assumptions are based on historical experience and other factors that are considered to be relevant. Number of shares (nominal value of DKK 1 each): 43,581,697 which is an increase of 39,859 from 43,428,192 as of June 30, 2021. Total number of shares and voting rights in Zealand Pharma as of September 30, 2021. På et bestyrelsesmøde i Selskabet afholdt den 10. april 2019 vedtog Selskabets bestyrelse at udstede warrants (2019-1 employee incentive program) svarende til nominelt DKK 397.750 aktier; og bestyrelsen vedtog samtidig at forhøje Selskabets aktiekapital i overensstemmelse dermed. 20 04 50 78), a biotechnology company focused on the discovery, development and commercialization of innovative peptide-based medicines, in accordance with . Management is responsible for the preparation of interim condensed consolidated financial statements in accordance with IAS 34 Interim Financial Reporting, as issued by the International Accounting Standards Board (IASB) and as adopted by the EU, and additional requirements of the Danish Financial Statements Act and for such internal control as Management determines is necessary to enable the preparation of interim condensed consolidated financial statements that are free from material misstatement, whether due to fraud or error. It's New Zealand's blueprint across formats — there are not too many people who do too many things. Community Schedule. This requires us to conclude whether anything has come to our attention that causes us to believe that the interim condensed consolidated financial statements, taken as a whole, are not prepared, in all material respects, in accordance with IAS 34 Interim Financial Reporting, as issued by the International Accounting Standards Board (IASB) and as adopted by the EU, and additional requirements of the Danish Financial Statements Act. 63 / 2021. Community Schedule. Recognized financial income can be specified as follows: Recognized financial expenses can be specified as follows: *Fair value adjustments for the 3 months period in Q3 2020and 2021 is a net income and therefore not included in the table as it is recognized under financial income in note 6. 106.500 warrants udstedt under dette program er pr.
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