Assets
| Type | Time | Amount | Unit |
|---|---|---|---|
| ifrs-full:Assets | 2022-12-31 | 58122000 | dkk |
| ifrs-full:Assets | 2021-12-31 | 173229000 | dkk |
Revenue
| Type | Start date | End date | Amount | Unit |
|---|---|---|---|---|
| ifrs-full:Revenue | 2022-01-01 | 2022-12-31 | 0 | dkk |
| ifrs-full:Revenue | 2021-01-01 | 2021-12-31 | 0 | dkk |
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<mrv:CorporateGovernanceReport contextRef="ctx-1" id="s9_notesesefdkgaap__7__21" xml:lang="en">Corporate Governance Orphazyme is committed to ensuring transparent and good corporate governance. As a Danish company listed on Nasdaq Copenhagen, Orphazyme is subject to the Danish Recommendations on Corporate Governance. The Recommendations on Corporate Governance are best practice guidelines for the management of companies admitted to trading on a regulated market. Orphazyme complies with the Recommendations on Corporate Governance where deemed relevant given Orphazymeâs current situation and focus. Therefore, the Company has opted to deviate in the following areas: ⢠Given the Companyâs current situation, and as the Company has focused its limited resources on handling the Companyâs restructuring proceedings, the Company has decided only to publish annual reports and half-yearly financial reports. ⢠The Company has limited resources and has therefore not provided and does not intend to provide a webcast or other digital transmission of the general meeting. ⢠The Company has focused on the restructuring proceedings, as well as assisting its legal representatives with a putative class action lawsuit in the United States, and therefore the Companyâs purpose is not currently being used actively as part of the Companyâs strategy. ⢠Given the Companyâs current situation, including limited resources and the size of the Board of Directors, at least half of the board members elected by the general meeting are not considered independent. Moreover, the majority of the members of the board committees are not considered independent. ⢠The Company has not included information in the annual report on board membersâ individual participation in board meetings and committee meetings. Any board member unable to attend a board or committee meeting has the opportunity to present his or her views or engage in dialogue with the Chairmanship regarding the items of the agenda prior to the board or committee meeting. Accordingly, a board member may contribute to the discussions at a board or committee meeting, even if he or she is not present. ⢠Given the Companyâs current situation, the Board of Directors has chosen not to adopt a policy for the Companyâs corporate social responsibility and tax, as the Company has focused its limited resources on handling the Companyâs restructuring proceedings. ⢠Given the Companyâs current situation, including limited resources, a member of the Executive Management is temporarily also a member of the Board of Directors. ⢠Given the Companyâs current situation, the Company has focused its limited resources on handling the Companyâs restructuring proceedings and legal matters. Therefore, the Company has not included information in the management commentary on the board committeesâ most significant activities and number of meetings in the past year. ⢠Given the Companyâs current situation, and as the Company has focused its limited resources on handling the Companyâs restructuring proceedings and legal matters, the Board of Directors has not engaged external assistance in the evaluation of the Board of Directors. ⢠The general conclusions of the latest evaluation of the Board of Directors are not described in the management commentary, however, the Chairman will account for the evaluation process and the general conclusions at the annual general meeting. ⢠Given the Companyâs current situation, the Company has not used its limited resources on considering the potential value of the variable remuneration at the time of exercise under pessimistic, expected, and optimistic scenarios. ⢠Share-based compensation, e.g. shares, share options, performance shares or warrants, constitutes a common part of the board remuneration in international biotech companies. Due to the Companyâs status as a biotech company, Orphazyme has programs in place which offers share-based incentives to the Board of Directors in the form of Restricted Share Units. As members of the Board of Directors are elected for a term of one year, the share-based instruments granted to board members have a vesting period of one year. No share-based incentives were granted to the Board of Directors in 2022. ⢠Orphazyme believes that share-based remuneration may serve shareholdersâ long-term interests as share-based incentives together with the base fee support the objective of lasting value creation for the shareholders. Orphazymeâs corporate governance statement includes a summary of the Companyâs governance structure, a description of internal control and financial reporting procedures, Orphazymeâs position on the Recommendation on Corporate Governance as well as a complete list of the Companyâs comments to recommendations that the Company opted to deviate from. The corporate governance statement is available under âCorporate Governanceâ in the Investors & Media section of our website: investors.orphazyme.com/corporate-governance. Board of Directors The Board of Directors is responsible for the overall management and strategic direction of Orphazymeâs business and operations and it supervises the Companyâs activities, management, and organization. The Board of Directors appoints and dismisses the members of the Executive Management, who are responsible for the day-to-day management of the Company. Meetings The Board of Directors normally holds at least five regular meetings annually, including a strategy review, plus ad-hoc meetings as required. Extraordinary board meetings are convened by the Chairman when necessary or when requested by a member of the Board of Directors, a member of the Executive Management, or by the Companyâs auditor. There was a higher frequency of meetings in H1 2022 due to the in-court restructuring process, and three Board meetings in H2 2022. The Board of Directors forms a quorum when more than half of its members are represented, including the Chairman or the Deputy Chairman. Resolutions of the Board of Directors are passed by a simple majority of the votes present at the meeting. In the event of equal votes, the Chairman or, in his absence, the Deputy Chairman shall have the casting vote. The Board of Directors conducts an annual evaluation of the effectiveness, performance, achievements, and competencies of the Board of Directors and of the individual members as well as the collaboration with the Executive Management. The members of the Board of Directors elected by the general meeting are elected for a term of one year. Members of the Board of Directors may be re-elected. Orphazyme Board of Directors (1)Name Position Independent Year of first Expiration of appointment term Bo Jesper Hansen Chairman Non-independent 2010 2023 John Sommer Schmidt Deputy Chairman Independent 2022 2023 Anders Vadsholt Member Non-independent 2022 2023 (1) According to the Danish Recommendations on Corporate Governance at least half of the members of the Board of Directors should be independent. Board Committees To support the Board of Directors in its duties, the Board of Directors has established and appointed an Audit Committee, a Nomination Committee, and a Remuneration Committee. These committees are charged with reviewing issues pertaining to their respective fields that are due to be considered at board meetings. The Board of Directors discontinued a Science Committee in May 2022. Audit Committee Members John Sommer Schmidt Bo Jesper Hansen (Chairman) (Member) Purpose & Key Roles ⢠Reviews and evaluates certain accounting and audit matters that by decision of the Board of Directors or the Audit Committee require a more thorough evaluation; ⢠Assesses internal controls and risk management systems; ⢠Supervises the Companyâs auditors and review the audit process; ⢠The Audit Committee Chairman monitors Orphazymeâs Whistleblower Hotline. Key Requirements ⢠No less than two members appointed by and among the Board of Directors, including the Chairman of the Audit Committee. ⢠The Chairman of the Board of Directors may not also be the Chairman of the Audit Committee. ⢠The members of the Audit Committee are required to meet the independence requirements set out in the Corporate Governance Recommendations. Currently, one member does not meet such independence requirements. ⢠At least one member shall have accounting or audit qualifications and between them, the members shall possess such expertise and experience to be able to provide an updated insight into, and experience in, the financial, accounting, and audit aspects of companies with shares admitted to and trading on a regulated market. ⢠The Companyâs external auditor shall participate in meetings of the Audit Committee if requested by the Audit Committee. ⢠The external auditor shall attend at least one meeting per year, of the relevant part thereof, where the Executive Management is not present. Nomination Committee Members Bo Jesper Hansen John Sommer Schmidt Anders Vadsholt (Chairman) (Member) (Member) Purpose & Key Roles ⢠Assists the Board of Directors in ensuring that appropriate plans and processes are in place for the nomination of candidates to the Board of Directors and the board committees; ⢠Evaluates the composition of the Board of Directors, including making recommendations for nomination or appointment of members of (a) the Board of Directors and (b) board committees. ⢠Evaluates the composition of the Executive Management annually, including making recommendations for nomination or appointment of members of the Executive Management; ⢠Assists the Board of Directors with ensuring that appropriate plans and processes are in place for nomination of candidates to the Executive Management. Key Requirements ⢠No less than three members appointed by and among the Board of Directors. ⢠The members of the Nomination Committee are required to meet the independence requirements set out in the Corporate Governance Recommendations. Currently, two members do not meet such independence requirements. Remuneration Committee Members Bo Jesper Hansen John Sommer Schmidt (Chairman) (Member) Purpose & Key Roles ⢠Ensures the Company maintains a Remuneration Policy for the members of the Board of Directors and the Executive Management; ⢠Evaluates and makes recommendations for the remuneration of the members of the Board of Directors and the Executive Management; ⢠Assist the review and preparation of the Companyâs Remuneration Report. Key Requirements ⢠No less than two members appointed by and among the Board of Directors. ⢠The members of the Remuneration Committee are required to meet the independence requirements set out in the Corporate Governance Recommendations. Currently, one member does not meet such independence requirements. Visit the Corporate Governance section under Investors & Media at www.orphazyme.com for more information. Internal controls and financial reporting procedures The Board of Directors, the Audit Committee, and the Executive Management are responsible for risk management and internal controls over its financial reporting and approve general policies in that regard. The Audit Committee assists the Board of Directors in overseeing the reporting process and the most important risks involved in this respect. The Executive Management is responsible for the effectiveness of the internal controls and risk management and for the implementation of such controls aimed at mitigating the risk associated with the financial reporting. The Board of Directors and Executive Management assess risks on an on-going basis, including risks related to financial reporting, and assess measures to manage, reduce, or eliminate identified risks. The Audit Committee reviews selected key risk areas on a frequent basis, including significant accounting estimates and material changes to accounting policies. At least once a year, the Audit Committee oversees a review of current internal controls to determine whether they are effective in relation to the risks identified in the financial reporting process. Orphazyme has adopted and defined an internal control framework that identifies key processes, inherent risks, and control procedures in order to secure appropriate accounting processes. The control procedures include a variety of processes in order to prevent any misrepresentation, significant errors, omissions, or fraudulent behavior. Orphazymeâs independent auditors are appointed for a term of one year by the shareholders at the Companyâs annual general meeting upon recommendation from the Audit Committee. The Board of Directors assesses the independence and competencies and other matters pertaining to the auditors. The framework for the auditorsâ compensation and duties, including audit and non-audit tasks, is agreed annually between the Board of Directors and the auditors based on recommendations from the Audit Committee.</mrv:CorporateGovernanceReport>
<mrv:StatementOfCorporateSocialResponsibility contextRef="ctx-1" id="s9_notesesefdkgaap__7__22" xml:lang="en">Corporate Social Responsibility This section constitutes the Companyâs statutory reporting according to Section 99a of the Danish Financial Statements Act. Our business Until recently, Orphazyme A/S was a biopharmaceutical company involved in the research and development of novel therapeutics for the treatment of neurodegenerative rare diseases. In May 2022, substantially all our assets and business activities were sold to KemPharm Denmark A/S, a wholly owned subsidiary of KemPharm Inc., and we now have limited ongoing operational business activities and employees. Our headquarters is in Copenhagen, and we have non-operating subsidiaries in the U.S. and Switzerland. Our responsibility Before the Sale of Assets, our primary purpose was working towards a common vision: To profoundly impact the lives of patients with underserved diseases. We established a team connected by a set of core values, focused on courage, integrity, care and perseverance, which underpinned our corporate culture and guided our responsibility towards society, patients, employees, and our stakeholders. In May 2022, the majority of our Danish employees were transferred to KemPharm, leaving us with minimal business operations and a couple of employees. As at December 31, 2022 there was only one permanent employee remaining at Orphazyme, CEO and CFO, Anders Vadsholt. In light of such limited business operations, Orphazymeâs Corporate and Social Responsibility (CSR) risks are considered very limited. Our CSR activities for 2022 were commensurate with the size and limited operations of the Company, though we continued to strive to uphold our values and responsibilities towards society, employees, and our stakeholders. For 2023 we will continue, where possible, to fulfill our CSR obligations as we execute our strategy. 2022 CSR reporting areas Human Rights Risk ⢠Very Limited: Orphazyme has limited operations, employees and suppliers. Actions ⢠Continued to respect internationally declared human rights and did not employ child labor. Policies in place Orphazyme acknowledges and supports the maintenance of internationally declared human rights and bases its work on the UN Universal Declaration of Human Rights and the interpretation that it is the responsibility of the State to protect, and the companiesâ responsibility to respect, these rights. Orphazyme interprets human rights to comprise respect for diversity. ⢠Diversity policy. ⢠Whistleblower policy. Results ⢠No diversity related incidents reported in 2022. ⢠No human rights violations reported in 2022. ⢠Employee composition: Not meaningful given company structure (One employee as of December 31, 2022; male). ⢠Leadership (director level and above): Not meaningful given company structure (One employee as of December 31, 2022; male). ⢠Due to the changes to the board of directors that occurred in connection with the Sale of Assets to KemPharm we no longer have an equal representation of men and women on the board of directors. Thus, the Company has set a target of increasing the representation of women on the Board of Directors to 40% by 2026 in accordance with the guidelines from the Danish Business Authority. As at year end 2022 the Board of Directors was comprised of three members, none of which were women. Future Plans ⢠Continue to support and respect internationally declared human rights and will not employ child labor. Aim to improve Board diversity in the future, subject to expansion of current business operations. Anti-Corruption & Bribery Risk ⢠Very Limited: We do not tolerate the use of bribery or corruption to achieve business objectives. Given that we have limited operations, employees and suppliers our anti-corruption and bribery risk is very limited. Actions ⢠The Company is committed to maintaining the highest standards of conduct and will not tolerate the use of bribery or corruption to achieve its business objectives. ⢠Anti-corruption and bribery training conducted when employees start. ⢠Legal & Compliance training refreshers, including anti-corruption and bribery Policies in place ⢠Our policies on bribery and corruption are clearly set out in our anti-corruption policy and our employee handbook. Results ⢠No bribery and corruption violations identified or reported in 2022. Future Plans ⢠Continue to maintain the highest standards of conduct and not tolerate the use of bribery or corruption to achieve business objectives. Environment & Climate Risk ⢠Very limited: We have a very limited number of employees, minimal physical office presence and use external suppliers for certain activities such as administration, finance and legal activities which we believe have a low potential risk for impact on the environment & climate. Prior to the Sale of Assets, a potential environment & climate risk was in regard to the use of hazardous substances in our laboratories. The Company conducted its research and development activities in a highly regulated industry and followed applicable rules on hazardous substances in order to minimize such risks. The Company closed its laboratory space in Q1 2022 and therefore the potential risk from such hazardous substances to the environment & climate is now zero. Actions ⢠Followed established procedures both during use and at disposal of hazardous substances. Policies in place ⢠Considering the business of the Company, and its limited operations and employees, Orphazymeâs general potential impact on the environment and climate and the impact of the climate on Orphazymeâs business is viewed as minimal. Applicable rules and procedures were followed regarding the use of hazardous substances (no longer relevant due to closure of our laboratory space early in 2022) and we continue to endeavor to protect the environment and climate through mindful business practices such as, e.g. careful use of office materials and energy consumption. Results ⢠Continued to keep records of all accidents in 2022. ⢠Recorded no records of spill of hazardous substances (monitored until our laboratory space was vacated in Q1 2022). ⢠Continued to focus on efficient energy use and management of office materials in 2022. Future Plans ⢠Orphazyme is no longer active in research and development activities associated with the use of hazardous substances and as such these potential risks have been minimized. Further, with only limited operating activities, employees and suppliers focusing on administration, finance and legal activities, the general potential impact on the environment and climate and the impact of the environment and climate on Orphazymeâs business is viewed as minimal. We will continue to endeavor to protect the environment and climate through mindful business practices such as, e.g. careful use of office materials and energy consumption. Social / Employees Risk ⢠Very Limited: As of December 31, 2022, Orphazyme had only one employee. The company continues to value diversity in gender, age, ethnicity, nationality, religion, education, sexual orientation, work history, perspectives, opinions, and skills at all levels of our business however given its limited employees it currently does not have a diverse workforce. Further, the Companyâs limited operations, such as office space and support network, could impact the working conditions of remaining employees. Actions ⢠The health and safety of our employees is of utmost importance and Orphazyme continually works to ensure that all systems and processes meet strict international standards. ⢠Continued to train laboratory employees in the systems, processes and workplace safety until closure of our laboratory space in Q1 2022. ⢠Continued to conduct regular mandatory Health and Safety surveys (APVs) assessing several aspects of the working environment such as psychological, ergonomics, and chemical working environment until employees transferred to KemPharm in June 2022. ⢠Continued to foster an open, trusting and inclusive workplace committed to freedom from discrimination, harassment, and bullying. ⢠We went through a significant business transformation in 2022 which resulted in some redundancies. We conducted our processes in accordance with applicable laws and regulations in the relevant jurisdictions and the processes were well planned with a clear focus on transparency and support. ⢠Continued to provide health insurance as standard for all our employees. Policies in place ⢠Diversity Policy. ⢠Health and Safety Policies. Results ⢠Assisted staff with IT and health support both in-office and at home working. ⢠Established a resilient culture centered on trust and collaboration. ⢠Due to the changes in the Company following the Sale of Assets Orphazyme ended the financial year December 31, 2022 with only one male employee, the CEO/CFO. Therefore, we believe diversity metrics for the period are not meaningful at this time. ⢠Leadership (director level and above): Not meaningful given company structure (One employee as of December 31,2022; male). Future Plans ⢠As of the date of this annual report, the Company has limited ongoing business activities and only one employee. Our future social / employee activities will be commensurate with the size and limited operations of the Company. We will continue to strive to uphold our values and responsibilities and promote a healthy, diverse and inclusive workplace, as we execute our strategy. Data Ethics Orphazyme operates in a highly regulated industry and the importance of responsible data handling is appreciated and followed across our organization. We currently do not have a data ethics policy but we have a Global Data Privacy Policy. Given the Company has limited operational business activities, it is no longer an integrated part of the Companyâs business strategy or activities to process data or use algorithms for data analysis in connection with clinical trials, etc. However, our practices will be evaluated on an ongoing basis in order to ensure they align with the statutory requirements set forth in Section 99d of the Danish Financial Statements Act. Diversity in management cf. §99b As of December 31, 2021, Orphazyme had 62 employees (FTEs), of which 58% were female and 42% were male. Of our employees at director level and above, 53% were female and 47% were male and, below director level, 63% of employees were female and 37% were male. In March 2022, Orphazyme entered in-court restructuring proceedings, resulting in a reduction in its workforce of approximately 50%. In May 2022, the majority of the remaining Danish employees were transferred to KemPharm, following the Sale of Assets. As at December 31, 2022, there was only one employee, Anders Vadsholt CEO and CFO. Given the size of our workforce, it is not meaningful to set out diversity figures nor is it required in accordance with the Danish Companies Act. The Board of Directors also saw some changes in 2022. At year-end 2021, the Board of Directors was comprised of five members, of which two (40%) were women. Due to the evolution of the business, there were only three Board members at the end of 2022, all of which were men. The company remains committed to promoting a diverse and inclusive workplace and has therefore set a target of increasing the representation of women on the Board of Directors to 40% by 2026 in accordance with the guidelines from the Danish Business Authority. Notes to Financial Statements SECTION 1 Basis of preparation and significant accounting policies</mrv:StatementOfCorporateSocialResponsibility>
<mrv:StatementOfPolicyForDataEthics contextRef="ctx-1" id="s9_notesesefdkgaap__7__23" xml:lang="en">Data Ethics Orphazyme operates in a highly regulated industry and the importance of responsible data handling is appreciated and followed across our organization. We currently do not have a data ethics policy but we have a Global Data Privacy Policy. Given the Company has limited operational business activities, it is no longer an integrated part of the Companyâs business strategy or activities to process data or use algorithms for data analysis in connection with clinical trials, etc. However, our practices will be evaluated on an ongoing basis in order to ensure they align with the statutory requirements set forth in Section 99d of the Danish Financial Statements Act.</mrv:StatementOfPolicyForDataEthics>
<mrv:StatementOfTheDiversityPolicies contextRef="ctx-1" id="s9_notesesefdkgaap__7__25" xml:lang="en">Diversity in management cf. §99b As of December 31, 2021, Orphazyme had 62 employees (FTEs), of which 58% were female and 42% were male. Of our employees at director level and above, 53% were female and 47% were male and, below director level, 63% of employees were female and 37% were male. In March 2022, Orphazyme entered in-court restructuring proceedings, resulting in a reduction in its workforce of approximately 50%. In May 2022, the majority of the remaining Danish employees were transferred to KemPharm, following the Sale of Assets. As at December 31, 2022, there was only one employee, Anders Vadsholt CEO and CFO. Given the size of our workforce, it is not meaningful to set out diversity figures nor is it required in accordance with the Danish Companies Act. The Board of Directors also saw some changes in 2022. At year-end 2021, the Board of Directors was comprised of five members, of which two (40%) were women. Due to the evolution of the business, there were only three Board members at the end of 2022, all of which were men. The company remains committed to promoting a diverse and inclusive workplace and has therefore set a target of increasing the representation of women on the Board of Directors to 40% by 2026 in accordance with the guidelines from the Danish Business Authority.</mrv:StatementOfTheDiversityPolicies>
<mrv:StatementOfTargetFiguresAndPoliciesForTheUnderrepresentedGender contextRef="ctx-1" id="s9_notesesefdkgaap__7__24" xml:lang="en">Diversity in management cf. §99b As of December 31, 2021, Orphazyme had 62 employees (FTEs), of which 58% were female and 42% were male. Of our employees at director level and above, 53% were female and 47% were male and, below director level, 63% of employees were female and 37% were male. In March 2022, Orphazyme entered in-court restructuring proceedings, resulting in a reduction in its workforce of approximately 50%. In May 2022, the majority of the remaining Danish employees were transferred to KemPharm, following the Sale of Assets. As at December 31, 2022, there was only one employee, Anders Vadsholt CEO and CFO. Given the size of our workforce, it is not meaningful to set out diversity figures nor is it required in accordance with the Danish Companies Act. The Board of Directors also saw some changes in 2022. At year-end 2021, the Board of Directors was comprised of five members, of which two (40%) were women. Due to the evolution of the business, there were only three Board members at the end of 2022, all of which were men. The company remains committed to promoting a diverse and inclusive workplace and has therefore set a target of increasing the representation of women on the Board of Directors to 40% by 2026 in accordance with the guidelines from the Danish Business Authority.</mrv:StatementOfTargetFiguresAndPoliciesForTheUnderrepresentedGender>
<fsa:AverageNumberOfEmployees contextRef="ctx-1"
decimals="0"
id="s9_notesesefdkgaap__7__72"
unitRef="pure">21</fsa:AverageNumberOfEmployees>
<fsa:AverageNumberOfEmployees contextRef="ctx-38"
decimals="0"
id="s9_notesesefdkgaap__8__72"
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<sob:StatementByExecutiveAndSupervisoryBoards contextRef="ctx-1" id="s9_notesesefdkgaap__7__145" xml:lang="en">Statements by Board of Directors and Executive Management The Board of Directors and Executive Management have today considered and approved the annual report of Orphazyme A/S for the financial year January 1-December 31, 2022. The consolidated financial statements of the Group and the Parent Companyâs financial statements have been prepared in accordance with International Financial Reporting Standards (IFRS) as issued by the International Accounting Standards Board (IASB) and in accordance with IFRS as endorsed by the EU as well as additional disclosure requirements under the Danish Financial Statements Act. In our opinion, the Groupâs consolidated financial statements and the Parent Company financial statements provide a fair presentation of the assets, liabilities, and financial position at December 31, 2022 and the results of the Groupâs and Parent Companyâs operations and cash flows for the financial year January 1âDecember 31, 2022. In our opinion, Managementâs Review provides a fair presentation of the development in the Groupâs operations and financial circumstances, the results of the year, and the overall financial position of the Group as well as a description of the most significant risks and elements of uncertainty facing the Group. We recommend that the annual report be adopted at the Annual General Meeting scheduled to be held on 17 May 2023.</sob:StatementByExecutiveAndSupervisoryBoards>
<sob:PlaceOfSignatureOfStatement contextRef="ctx-1" id="s9_notesesefdkgaap__7__146" xml:lang="en">Copenhagen</sob:PlaceOfSignatureOfStatement>
<cmn:NameAndSurnameOfMemberOfSupervisoryBoard contextRef="ctx-32" id="s9_notesesefdkgaap__7__148" xml:lang="en">Bo Jesper Hansen</cmn:NameAndSurnameOfMemberOfSupervisoryBoard>
<cmn:NameAndSurnameOfMemberOfSupervisoryBoard contextRef="ctx-33" id="s9_notesesefdkgaap__7__150" xml:lang="en">John Sommer Schmidt</cmn:NameAndSurnameOfMemberOfSupervisoryBoard>
<cmn:TitleOfMemberOfSupervisoryBoard contextRef="ctx-32" id="s9_notesesefdkgaap__7__149" xml:lang="en">Chairman of the Board</cmn:TitleOfMemberOfSupervisoryBoard>
<cmn:TitleOfMemberOfSupervisoryBoard contextRef="ctx-33" id="s9_notesesefdkgaap__7__151" xml:lang="en">Deputy Chairman of the Board</cmn:TitleOfMemberOfSupervisoryBoard>
<cmn:TitleOfMemberOfSupervisoryBoard contextRef="ctx-34" id="s9_notesesefdkgaap__7__152" xml:lang="en">Anders Vadsholt</cmn:TitleOfMemberOfSupervisoryBoard>
<cmn:NameAndSurnameOfMemberOfExecutiveBoard contextRef="ctx-35" id="s9_notesesefdkgaap__7__153" xml:lang="en">Anders Vadsholt</cmn:NameAndSurnameOfMemberOfExecutiveBoard>
<cmn:TitleOfMemberOfExecutiveBoard contextRef="ctx-35" id="s9_notesesefdkgaap__7__154" xml:lang="en">Chief Executive Officer</cmn:TitleOfMemberOfExecutiveBoard>
<arr:AddresseeOfAuditorsReportOnAuditedFinancialStatements contextRef="ctx-1" id="s9_notesesefdkgaap__7__157" xml:lang="en">To the Shareholders of Orphazyme A/S</arr:AddresseeOfAuditorsReportOnAuditedFinancialStatements>
<arr:OpinionOnAuditedFinancialStatements contextRef="ctx-1" id="s9_notesesefdkgaap__7__158" xml:lang="en">Opinion We have audited the consolidated financial statements and the parent company financial statements of Orphazyme A/S for the financial year 1 January â 31 December 2022, which comprise income statement, statement of comprehensive income, balance sheet, statement of changes in equity, cash flow statement and notes, including accounting policies, for the Group and the Parent Company. The consolidated financial statements and the parent company financial statements are prepared in accordance with International Financial Reporting Standards as adopted by the EU and additional requirements of the Danish Financial Statements Act. In our opinion, the consolidated financial statements and the parent company financial statements give a true and fair view of the financial position of the Group and the Parent Company at 31 December 2022 and of the results of the Group's and the Parent Company's operations and cash flows for the financial year 1 January â 31 December 2022 in accordance with International Financial Reporting Standards as adopted by the EU and additional requirements of the Danish Financial Statements Act. Our opinion is consistent with our long-form audit report to the Audit Committee and the Board of Directors.</arr:OpinionOnAuditedFinancialStatements>
<arr:DescriptionOfQualificationsOfAuditedFinancialStatements contextRef="ctx-1" id="s9_notesesefdkgaap__7__159" xml:lang="en">Basis for opinion We conducted our audit in accordance with International Standards on Auditing (ISAs) and additional requirements applicable in Denmark. Our responsibilities under those standards and requirements are further described in the "Auditor's responsibilities for the audit of the consolidated financial statements and the parent company financial statements" (hereinafter collectively referred to as "the financial statements") section of our report. We believe that the audit evidence we have obtained is sufficient and appropriate to provide a basis for our opinion. Independence We are independent of the Group in accordance with the International Ethics Standards Board for Accountants' International Code of Ethics for Professional Accountants (IESBA Code) and the additional ethical requirements applicable in Denmark, and we have fulfilled our other ethical responsibilities in accordance with these requirements and the IESBA Code. To the best of our knowledge, we have not provided any prohibited non-audit services as described in article 5(1) of Regulation (EU) no. 537/2014. Emphasis of matter in the financial statements We draw attention to note 3.9 to the financial statements, which describes the material uncertainty associated with the outcome of a class action lawsuit that was filed against the Company and certain of its current and former officers and directors. We have not modified our opinion in respect of this matter. Appointment of auditor We were initially appointed as auditor of Orphazyme A/S on 4 December 2015 for the financial period 1 July to 31 December 2015. We have been reappointed annually by resolution of the general meeting for a total consecutive period of 8 years up until the financial year 2022.</arr:DescriptionOfQualificationsOfAuditedFinancialStatements>
<arr:KeyAuditMattersAudit contextRef="ctx-1" id="s9_notesesefdkgaap__7__160" xml:lang="en">Key audit matters Key audit matters are those matters that, in our professional judgement, were of most significance in our audit of the financial statements for the financial year 2022. These matters were addressed during our audit of the financial statements as a whole and in forming our opinion thereon. We do not provide a separate opinion on these matters. For each matter below, our description of how our audit addressed the matter is provided in that context. We have fulfilled our responsibilities described in the "Auditor's responsibilities for the audit of the financial statements" section, including in relation to the key audit matters below. Accordingly, our audit included the design and performance of procedures to respond to our assessment of the risks of material misstatement of the financial statements. The results of our audit procedures, including the procedures performed to address the matters below, provide the basis for our audit opinion on the financial statements. Accounting for discontinued Operations (IFRS 5) In May 2022, as a part of the restructuring proposal to the Danish Maritime and Commercial High Court and Orphazymeâs known creditors, the Company announced that it had sold substantially all of the Companyâs assets and business activities , including those relating to the development and approval of arimoclomol and the full claw back liability related to the French early access program, to KemPharm Denmark A/S for a total of DKK 88.8 million (USD 12.8 million) in cash and assumed liabilities estimated to equal approximately DKK 36.2 million (USD 5.2 million). The sale of assets and business activities was completed on May 31, 2022. The net result of discontinued operations amounts to DKK 64.4 million in 2022, including a gain from disposal of the discontinued operations of DKK 145.5 million. Management concluded that the sale of the assets and business activities should be reported in accordance with IFRS 5 - Non-Current Assets Held for Sale as discontinued operations in the 2022 financial statements. The application of IFRS 5 is significant to our audit because the transaction and its accounting is non-routine and involves significant management judgements regarding the presentation of the net result as discontinued operations. As a result of these conclusions, there are requirements around the presentation in the financial statements and disclosure notes, the identification of income and expenses allocated to the discontinued operations and continued operations, including assumptions and estimates made with regard to the allocation and presentation, and adjustments to be recorded, e.g. common cost allocations. How our audit addressed the matter Our audit procedures included an evaluation of the Companyâs conclusions on the classification and presentation of the business activities as discontinued operations. Our audit procedures on the accounting and disclosure of reported net result from discontinued operations focused on the validation with the underlying sales documents and related contracts, agreed the elements of the gain calculations to them, testing of received proceeds per bank statements, performing cut-off procedures on material balance sheet items and income statement items and assessing the assumption applied by management to reassess the potential exposure on the continued operations. We assessed the presentation of discontinued and continuing operations by reference to its size and nature. We also tested whether the comparative figures in the statement of comprehensive income for the discontinued operations were accurately and fully adjusted. We refer to note 1.7 in the financial statements regarding discontinued operations.</arr:KeyAuditMattersAudit>
<arr:StatementOnManagementsReviewAuditorsReportOnAuditedFinancialStatements contextRef="ctx-1" id="s9_notesesefdkgaap__7__161" xml:lang="en">Statement on the Management's review Management is responsible for the Management's review. Our opinion on the financial statements does not cover the Management's review, and we do not express any form of assurance conclusion thereon. In connection with our audit of the financial statements, our responsibility is to read the Management's review and, in doing so, consider whether the Management's review is materially inconsistent with the financial statements or our knowledge obtained during the audit, or otherwise appears to be materially misstated. Moreover, it is our responsibility to consider whether the Management's review provides the information required under the Danish Financial Statements Act. Based on the work we have performed, we conclude that the Management's review is in accordance with the financial statements and has been prepared in accordance with the requirements of the Danish Financial Statements Act. We did not identify any material misstatement of the Management's review.</arr:StatementOnManagementsReviewAuditorsReportOnAuditedFinancialStatements>
<arr:StatementOfExecutiveAndSupervisoryBoardsResponsibilityForFinancialStatements contextRef="ctx-1" id="s9_notesesefdkgaap__7__162" xml:lang="en">Management's responsibilities for the financial statements Management is responsible for the preparation of consolidated financial statements and parent company financial statements that give a true and fair view in accordance with International Financial Reporting Standards 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 financial statements that are free from material misstatement, whether due to fraud or error. In preparing the financial statements, Management is responsible for assessing the Group's and the Parent Company's ability to continue as a going concern, disclosing, as applicable, matters related to going concern and using the going concern basis of accounting in preparing the financial statements unless Management either intends to liquidate the Group or the Parent Company or to cease operations, or has no realistic alternative but to do so.</arr:StatementOfExecutiveAndSupervisoryBoardsResponsibilityForFinancialStatements>
<arr:StatementOfAuditorsResponsibilityForAuditAndAuditPerformed contextRef="ctx-1" id="s9_notesesefdkgaap__7__163" xml:lang="en">Auditor's responsibilities for the audit of the financial statements Our objectives are to obtain reasonable assurance as to whether the financial statements as a whole are free from material misstatement, whether due to fraud or error, and to issue an auditor's report that includes our opinion. Reasonable assurance is a high level of assurance, but is not a guarantee that an audit conducted in accordance with ISAs and additional requirements applicable in Denmark will always detect a material misstatement when it exists. Misstatements can arise from fraud or error and are considered material if, individually or in the aggregate, they could reasonably be expected to influence the economic decisions of users taken on the basis of the financial statements. As part of an audit conducted in accordance with ISAs and additional requirements applicable in Denmark, we exercise professional judgement and maintain professional scepticism throughout the audit. We also: ⢠Identify and assess the risks of material misstatement of the financial statements, whether due to fraud or error, design and perform audit procedures responsive to those risks and obtain audit evidence that is sufficient and appropriate to provide a basis for our opinion. The risk of not detecting a material misstatement resulting from fraud is higher than for one resulting from error, as fraud may involve collusion, forgery, intentional omissions, misrepresentations or the override of internal control. ⢠Obtain an understanding of internal control relevant to the audit in order to design audit procedures that are appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectiveness of the Group's and the Parent Company's internal control. ⢠Evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimates and related disclosures made by Management. ⢠Conclude on the appropriateness of Management's use of the going concern basis of accounting in preparing the financial statements and, based on the audit evidence obtained, whether a material uncertainty exists related to events or conditions that may cast significant doubt on the Group's and the Parent Company's ability to continue as a going concern. If we conclude that a material uncertainty exists, we are required to draw attention in our auditor's report to the related disclosures in the financial statements or, if such disclosures are inadequate, to modify our opinion. Our conclusions are based on the audit evidence obtained up to the date of our auditor's report. However, future events or conditions may cause the Group and the Parent Company to cease to continue as a going concern. ⢠Evaluate the overall presentation, structure and contents of the financial statements, including the note disclosures, and whether the financial statements represent the underlying transactions and events in a manner that gives a true and fair view. ⢠Obtain sufficient appropriate audit evidence regarding the financial information of the entities or business activities within the Group to express an opinion on the consolidated financial statements. We are responsible for the direction, supervision and performance of the group audit. We remain solely responsible for our audit opinion. We communicate with those charged with governance regarding, among other matters, the planned scope and timing of the audit and significant audit findings, including any significant deficiencies in internal control that we identify during our audit. We also provide those charged with governance with a statement that we have complied with relevant ethical requirements regarding independence, and to communicate with them all relationships and other matters that may reasonably be thought to bear on our independence, and where applicable, actions taken to eliminate threats or safeguards applied. From the matters communicated with those charged with governance, we determine those matters that were of most significance in the audit of the consolidated financial statements and the parent company financial statements of the current period and are therefore the key audit matters. We describe these matters in our auditor's report unless law or regulation precludes public disclosure about the matter.</arr:StatementOfAuditorsResponsibilityForAuditAndAuditPerformed>
<arr:AuditorsReportOnXbrlTagging contextRef="ctx-1" id="s9_notesesefdkgaap__7__164" xml:lang="en">Report on compliance with the ESEF Regulation As part of our audit of the Consolidated Financial Statements and Parent Company Financial Statements of Orphazyme A/S, we performed procedures to express an opinion on whether the annual report of Orphazyme A/S for the financial year 1 January â 31 December 2022 with the file name 54930025OZD2GGSQ7L42-2022-12-31-en is prepared, in all material respects, in compliance with the Commission Delegated Regulation (EU) 2019/815 on the European Single Electronic Format (ESEF Regulation) which includes requirements related to the preparation of the annual report in XHTML format and iXBRL tagging of the Consolidated Financial Statements including notes. Management is responsible for preparing an annual report that complies with the ESEF Regulation. This responsibility includes: ⢠The preparing of the annual report in XHTML format; ⢠The selection and application of appropriate iXBRL tags, including extensions to the ESEF taxonomy and the anchoring thereof to elements in the taxonomy, for all financial information required to be tagged using judgement where necessary; ⢠Ensuring consistency between iXBRL tagged data and the Consolidated Financial Statements presented in human readable format; and ⢠For such internal control as Management determines necessary to enable the preparation of an annual report that is compliant with the ESEF Regulation. Our responsibility is to obtain reasonable assurance on whether the annual report is prepared, in all material respects, in compliance with the ESEF Regulation based on the evidence we have obtained, and to issue a report that includes our opinion. The nature, timing and extent of procedures selected depend on the auditorâs judgement, including the assessment of the risks of material departures from the requirements set out in the ESEF Regulation, whether due to fraud or error. The procedures include: ⢠Testing whether the annual report is prepared in XHTML format; ⢠Obtaining an understanding of the companyâs iXBRL tagging process and of internal control over the tagging process; ⢠Evaluating the completeness of the iXBRL tagging of the Consolidated Financial Statements including notes; ⢠Evaluating the appropriateness of the companyâs use of iXBRL elements selected from the ESEF taxonomy and the creation of extension elements where no suitable element in the ESEF taxonomy has been identified; ⢠Evaluating the use of anchoring of extension elements to elements in the ESEF taxonomy; and ⢠Reconciling the iXBRL tagged data with the audited Consolidated Financial Statements. In our opinion, the annual report of Orphazyme A/S for the financial year 1 January â 31 December 2022 with the file name 54930025OZD2GGSQ7L42-2022-12-31-en is prepared, in all material respects, in compliance with the ESEF Regulation.</arr:AuditorsReportOnXbrlTagging>
<arr:SignatureOfAuditorsPlace contextRef="ctx-1" id="s9_notesesefdkgaap__7__165" xml:lang="en">Copenhagen</arr:SignatureOfAuditorsPlace>
<cmn:NameOfAuditFirm contextRef="ctx-37" id="s9_notesesefdkgaap__7__168" xml:lang="en">EY Godkendt Revisionspartnerselskab</cmn:NameOfAuditFirm>
<cmn:NameOfAuditFirm contextRef="ctx-36" id="s9_notesesefdkgaap__7__167" xml:lang="en">EY Godkendt Revisionspartnerselskab</cmn:NameOfAuditFirm>
<cmn:IdentificationNumberCvrOfAuditFirm contextRef="ctx-36" id="s9_notesesefdkgaap__7__169" xml:lang="en">30700228</cmn:IdentificationNumberCvrOfAuditFirm>
<cmn:IdentificationNumberCvrOfAuditFirm contextRef="ctx-37" id="s9_notesesefdkgaap__7__170" xml:lang="en">30700228</cmn:IdentificationNumberCvrOfAuditFirm>
<cmn:NameAndSurnameOfAuditor contextRef="ctx-36" id="s9_notesesefdkgaap__7__171" xml:lang="en">Hans B. Vistisen</cmn:NameAndSurnameOfAuditor>
<cmn:DescriptionOfAuditor contextRef="ctx-36" id="s9_notesesefdkgaap__7__172" xml:lang="en">State Authorised Public Accountant</cmn:DescriptionOfAuditor>
<cmn:IdentificationNumberOfAuditor contextRef="ctx-36" id="s9_notesesefdkgaap__7__173" xml:lang="en">mne23254</cmn:IdentificationNumberOfAuditor>
<cmn:NameAndSurnameOfAuditor contextRef="ctx-37" id="s9_notesesefdkgaap__7__174" xml:lang="en">Anders Roe Eriksen</cmn:NameAndSurnameOfAuditor>
<cmn:DescriptionOfAuditor contextRef="ctx-37" id="s9_notesesefdkgaap__7__175" xml:lang="en">State Authorised Public Accountant</cmn:DescriptionOfAuditor>
<cmn:IdentificationNumberOfAuditor contextRef="ctx-37" id="s9_notesesefdkgaap__7__176" xml:lang="en">mne46667</cmn:IdentificationNumberOfAuditor>
<gsd:InformationOnTypeOfSubmittedReport contextRef="ctx-1" xml:lang="en">Annual report</gsd:InformationOnTypeOfSubmittedReport>
<cmn:TypeOfAuditorAssistance contextRef="ctx-1" xml:lang="en">Auditor's report on audited financial statements</cmn:TypeOfAuditorAssistance>
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<gsd:ReportingPeriodStartDate contextRef="ctx-1" xml:lang="en">2022-01-01</gsd:ReportingPeriodStartDate>
<gsd:ReportingPeriodEndDate contextRef="ctx-1" xml:lang="en">2022-12-31</gsd:ReportingPeriodEndDate>
<gsd:PrecedingReportingPeriodStartDate contextRef="ctx-1" xml:lang="en">2021-01-01</gsd:PrecedingReportingPeriodStartDate>
<gsd:PredingReportingPeriodEndDate contextRef="ctx-1" xml:lang="en">2021-12-31</gsd:PredingReportingPeriodEndDate>
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<fsa:ClassOfReportingEntity contextRef="ctx-1" xml:lang="en">Reporting class D</fsa:ClassOfReportingEntity>
<arr:TypeOfModifiedOpinionOnAuditedFinancialStatements contextRef="ctx-1" xml:lang="en">Opinion</arr:TypeOfModifiedOpinionOnAuditedFinancialStatements>
<arr:TypeOfBasisForModifiedOpinionOnAuditedFinancialStatements contextRef="ctx-1" xml:lang="en">Basis for Opinion</arr:TypeOfBasisForModifiedOpinionOnAuditedFinancialStatements>
<sob:DateOfApprovalOfAnnualReport contextRef="ctx-1" xml:lang="en">2023-04-25</sob:DateOfApprovalOfAnnualReport>
<cmn:TitleOfMemberOfExecutiveBoard contextRef="ctx-35" xml:lang="en">Chief Financial Officer</cmn:TitleOfMemberOfExecutiveBoard>
<arr:SignatureOfAuditorsDate contextRef="ctx-1" xml:lang="en">2023-04-25</arr:SignatureOfAuditorsDate>
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