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|---|---|---|---|
| ifrs-full:Assets | 2021-12-31 | 173229000 | dkk |
| ifrs-full:Assets | 2020-12-31 | 822493000 | dkk |
Revenue
| Type | Start date | End date | Amount | Unit |
|---|---|---|---|---|
| ifrs-full:Revenue | 2021-01-01 | 2021-12-31 | 36193000 | dkk |
| ifrs-full:Revenue | 2020-01-01 | 2020-12-31 | 0 | dkk |
| ifrs-full:Revenue | 2019-01-01 | 2019-12-31 | 0 | dkk |
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<mrv:CorporateGovernanceReport contextRef="ctx-1" id="pp-value-3" xml:lang="en">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 intends to comply with the Recommendations on Corporate Governance in all material respects, however, given Orphazymeâs current situation and focus, the Company has opted to deviate from the recommendations in the following areas: ⢠Orphazyme has decided to only publish annual reports and half-yearly financial reports; ⢠the Company has not adopted a corporate social responsibility policy; ⢠the Company has not adopted a tax policy; ⢠the annual report does not include information on individual board membersâ participation in board meetings and committee meetings; ⢠the annual report does not include information on the board committeeâs most significant activities and number of board committee meetings held in the past year; ⢠the general conclusion of the latest evaluation of the Board of Directors is not described in the annual report, but is accounted for by the Chairman at the annual general meeting and ⢠share-based remuneration is offered to the Board of Directors and has a maturity of one year from the date of allocation. 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 in the Investors & Media section of our website through this link: 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 2021 due to the unfavorable events experienced in 2021. 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 Georges Gemayel Chairman Independent 2012 2022 Bo Jesper Hansen Deputy Chairman Independent 2010 2022 Andrew Mercieca Member Independent 2022 2023 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 has decided to discontinue the Science Committee with effect from May 2022. Audit Committee Members ⢠Andrew Mercieca (Chairman) ⢠Bo Jesper Hansen ⢠Georges Gemayel 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 three 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. The members 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. ⢠Anders Vadsholt, in his capacity as the CEO and CFO and 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 (Chairman) ⢠Georges Gemayel 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. The members meet such independence requirements. Remuneration Committee Members ⢠Bo Jesper Hansen (Chairman) ⢠Georges Gemayel ⢠Andrew Mercieca 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 three 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. The members meet such independence. 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="pp-value-7" xml:lang="en">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 In 2021, our focus at Orphazyme was on 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. Below we describe Orphazymeâs most significant Corporate Social Responsibility (CSR) risks and how we handled them for the 2021 financial year. As of the date of this annual report, the Company has limited ongoing business activities and only two employees which we believe significantly reduces the companyâs CSR risks at this time. â Our future CSR activities will be commensurate with the size and limited operations of the Company. We will continue to strive to uphold our values and responsibilities, where possible, as we execute our strategy. 2021 CSR reporting areas Human Rights Risk ⢠Limited: Orphazyme conducts business in a highly regulated industry. Actions ⢠Continued to respect internationally declared human rights and did not employ child labor. ⢠Trained employees in relation to whistleblower policy. ⢠Continued to support Board diversity, electing one additional female member to the board of directors during 2021. Policies in place ⢠Diversity policy to increase diversity among members of the Board of Directors and other management levels. ⢠Whistleblower policy to enable reporting of potential violations. Results ⢠No diversity related incidents reported. ⢠No human rights violations reported. ⢠Balanced employee composition: 58% female, 42% male. ⢠Leadership (director level and above) 53% / 47% gender balance. ⢠Reached board of directors diversity target. As at year end 2021 there were 2 female board members, equating to 40% of the board. As of the date of this annual report, the Board of Directors is comprised ofthree members, none of which are women. Future Plansâ ⢠Continue to support and respect internationally declared human rights and will not employ child labor. Anti-Corruption & Bribery Risk ⢠Limited: Orphazyme conducts business in a highly regulated industry. The Company is committed to maintaining the highest standards of conduct and will not tolerate the use of bribery or corruption toachieve its business objectives. Actions ⢠Anti-corruption and bribery training in onboarding of all employees ⢠Legal & Compliance training refreshers, including anti-corruption and bribery ⢠Expanded our commitment to anti-bribery & corruption and implemented a global policy on good promotional practice, global policy on interactions with healthcare professionals and healthcareorganizations and global policy on fee-for-service engagement of healthcare professionals, healthcareorganizations and patient organizations.. 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 2021. Future Plansâ ⢠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 (direct risk): We have a modest number of employees and use external suppliers for certain activities such as clinical trials and product manufacturing. The Company conducts its business in ahighly regulated industry and follows applicable rules on hazardous substances. As such, use ofhazardous substances is connected with a very low and controlled risk. Actions ⢠Followed established procedures both during use and at disposal of hazardous substances. Policies in place ⢠Considering the business of the Company, Orphazymeâs general potential impact on the environment and climate and the impact of the climate on Orphazymeâs business is viewed as minimal. As such,specific environment and climate policies have not been developed at this time. Results ⢠Continued to keep records of all accidents. ⢠No records of spill of hazardous substances. ⢠Continued to focus on efficient management of office materials.Future Plans â ⢠Orphazyme is no longer active in research and development activities associated with the use ofhazardous substances and such risks have accordingly been minimized. Further, with only limitedoperating activities and employees, the general potential impact on the environment and climate and theimpact of the climate on Orphazymeâs business is viewed as minimal and no specific environment andclimate policies are planned at this time.Business Ethics Risk ⢠Limited: Orphazyme is committed to conducting business in a manner that ensures that no Orphazymerepresentatives are influenced by undue personal interests and that the Companyâs directors, officers, andemployees adhere to specific guidelines in the conduct of the Companyâs business.Actions ⢠Continued to train existing employees in business ethics and conflict of interest through our risk andcompliance system.⢠Continued to include business ethics and conflict of interest in onboarding training of all new employees.Policies in place ⢠Conflict of interest policy.⢠Code of business conduct & ethics.Results ⢠High awareness on ethical business conduct by Orphazyme representatives.⢠No instances of unethical behaviors escalated to senior management.â Future Plans ⢠Continue our commitment to conducting our business ethically, fairly, and with integrity.</mrv:StatementOfCorporateSocialResponsibility>
<mrv:StatementOfTheDiversityPolicies contextRef="ctx-1" id="pp-value-9" xml:lang="en">Risk ⢠Limited: Orphazyme conducts business in a highly regulated industry. We believe a diverse, skilled, andhealthy workforce is crucial to the success of Orphazyme and our ability to serve patients and the raredisease community. We value diversity in gender, age, ethnicity, nationality, religion, education, sexualorientation, work history, perspectives, opinions, and skills at all levels of our business.Actions ⢠The health and safety of our employees is of utmost importance and Orphazyme continually works toensure that all systems and processes meet strict international standards.⢠Continued to train laboratory employees in the systems, processes and mandatory and ongoing educationrelating to workplace safety.⢠Continued to conduct regular mandatory Health and Safety surveys (APVs) assessing several aspects ofthe working environment such as psychological, ergonomics, and chemical working environment.⢠Recruitment process focused on balancing representation in our teams.⢠Fostered an inclusive workplace committed to freedom from discrimination, harassment, and bullying.⢠Continued our employee initiatives including all staff townhall meetings, social events, hybrid flexibleworking, and fostering an open and trusting work environment. Characterized by psychological safety.⢠Provided frequent updates to keep staff healthy and safe during COVID pandemic.⢠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.⢠Maintained a diverse workforce consisting of 58% women and 42% men.⢠Leadership (director level and above) 53% / 47% gender balance.⢠Workplace assessment survey: 92% satisfaction with physical work environment; 82% satisfaction withpsychosocial work environment.⢠Culture survey confirmed that Orphazyme has a clear and meaningful purpose.⢠Established a resilient culture centered on trust and collaboration.â Future Plans ⢠As of the date of this annual report, the Company has limited ongoing business activities and only twoemployees. Our future social / employee activities will be commensurate with the size and limitedoperations of the Company. We will continue to strive to uphold our values and responsibilities andpromote a diverse and inclusive workplace, as we execute our strategy.</mrv:StatementOfTheDiversityPolicies>
<mrv:StatementOfPolicyForDataEthics contextRef="ctx-1" id="pp-value-12" xml:lang="en">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 now has limited operational business activities, particularly in the area of clinical trials where the importance of data privacy and regulations are paramount, we will evaluate our practices to ensure they align with the new statutory requirements set forth in Section 99d of the Danish Financial Statements Act. </mrv:StatementOfPolicyForDataEthics>
<mrv:StatementOfTargetFiguresAndPoliciesForTheUnderrepresentedGender contextRef="ctx-1" id="pp-value-13" xml:lang="en">In July 2021, we implemented a restructuring plan, reducing our workforce by two-thirds while retaining core expertise to enable us to achieve our goal of gaining approval for arimoclomol in NPC. As of December 31, 2021, we had 62 employees (FTEs), of which 58% were female and 42% were male. Of ouremployees 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. Overall, most employees at year-end 2021 were in the areas of finance, legal, IT and administration (25%), clinical (22%) and commercial/pre-launch (20%). Since the end of 2021, there have been some voluntary employee departures and in March 2022 Orphazyme entered in-court restructuring proceedings, resulting in a reduction in its workforce of approximately 50%. As of the date of this annual report, there are two employees, including Executive Management. The Board of Directors also saw some changes during 2021, with the departure of three male members and one female member. At year-end 2021, the Board of Directors was comprised of five members, of which two (40%)were women. In February 2022, Andrew Mercieca was appointed to the Board of directors, taking the Board tosix members, of which two (33%) are women. The Board of Directors was further changed in May 2022, with the departure of Stephanie Okey, Carrolee Barlow and Martin Bonde. As of the date of this annual report, the Board of Directors is comprised of three members, none of which are women. </mrv:StatementOfTargetFiguresAndPoliciesForTheUnderrepresentedGender>
<gsd:HomepageOfReportingEntity contextRef="ctx-1" id="pp-value-15" xml:lang="en">www.orphazyme.com</gsd:HomepageOfReportingEntity>
<fsa:AverageNumberOfEmployees contextRef="ctx-1" decimals="0" unitRef="pure">130</fsa:AverageNumberOfEmployees>
<fsa:AverageNumberOfEmployees contextRef="ctx-46" decimals="0" unitRef="pure">117</fsa:AverageNumberOfEmployees>
<fsa:AverageNumberOfEmployees contextRef="ctx-47" decimals="0" unitRef="pure">74</fsa:AverageNumberOfEmployees>
<sob:StatementByExecutiveAndSupervisoryBoards contextRef="ctx-1" id="pp-value-29" xml:lang="en">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, 2021. 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, 2021 and the results of the Groupâs and Parent Companyâs operations and cash flows for the financial year January 1âDecember 31, 2021. 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 June 29, 2022 </sob:StatementByExecutiveAndSupervisoryBoards>
<sob:PlaceOfSignatureOfStatement contextRef="ctx-1" id="pp-value-21" xml:lang="en">Copenhagen,</sob:PlaceOfSignatureOfStatement>
<cmn:NameAndSurnameOfMemberOfSupervisoryBoard contextRef="ctx-49" id="pp-value-23" xml:lang="en">Bo Jesper Hansen </cmn:NameAndSurnameOfMemberOfSupervisoryBoard>
<cmn:TitleOfMemberOfSupervisoryBoard contextRef="ctx-49" id="pp-value-25" xml:lang="en">Deputy Chairman of the Board </cmn:TitleOfMemberOfSupervisoryBoard>
<cmn:NameAndSurnameOfMemberOfSupervisoryBoard contextRef="ctx-48" id="pp-value-22" xml:lang="en">Georges Gemayel </cmn:NameAndSurnameOfMemberOfSupervisoryBoard>
<cmn:TitleOfMemberOfSupervisoryBoard contextRef="ctx-48" id="pp-value-24" xml:lang="en">Chairman of the Board </cmn:TitleOfMemberOfSupervisoryBoard>
<cmn:NameAndSurnameOfMemberOfSupervisoryBoard contextRef="ctx-50" id="pp-value-26" xml:lang="en">Andrew Mercieca </cmn:NameAndSurnameOfMemberOfSupervisoryBoard>
<cmn:NameAndSurnameOfMemberOfExecutiveBoard contextRef="ctx-51" xml:lang="en">Anders Vadsholt </cmn:NameAndSurnameOfMemberOfExecutiveBoard>
<cmn:TitleOfMemberOfExecutiveBoard contextRef="ctx-51" id="pp-value-28" xml:lang="en">Chief Executive Officer and Chief Financial Officer </cmn:TitleOfMemberOfExecutiveBoard>
<arr:AddresseeOfAuditorsReportOnAuditedFinancialStatements contextRef="ctx-1" xml:lang="en">To the Shareholders of Orphazyme A/S</arr:AddresseeOfAuditorsReportOnAuditedFinancialStatements>
<arr:OpinionOnAuditedFinancialStatements contextRef="ctx-1" id="pp-value-31" xml:lang="en">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 2021, 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 FinancialReporting 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 2021 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 2021 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="pp-value-32" xml:lang="en">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 requirementsapplicable 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. Appointment of auditor We were initially appointed as auditor of Orphazyme A/S on 4 December 2015 for the financial year for 1 July to 31 December 2015. We have been reappointed annually by resolution of the general meeting for a total consecutive period of 7 years up until the financial year 2021. </arr:DescriptionOfQualificationsOfAuditedFinancialStatements>
<arr:KeyAuditMattersAudit contextRef="ctx-1" id="pp-value-33" xml:lang="en">Key audit matters are those matters that, in our professional judgement, were of most significance in our audit ofthe financial statements for the financial year 2021. 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 the 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 clawback liability related to the Companyâs sales under the early access compassionate use programs in France As disclosed in Note 2.1 to the consolidated financial statements, revenue from the sale of arimoclomol for the treatment of NPC under the remunerated early access compassionate use program (ânATUâ) in France is measured net of estimated clawback liability to the French Authorities. The estimates for clawback liability to the French Authorities are recognised as a reduction to gross product sales in the period in which the underlying sales are recognised. As of December 31, 2021, the liabilities for clawback amounts to DKK 36.2 million, as disclosed in Note 3.7 in the consolidated financial statements. Estimating the clawback liability to the French Authorities is complex due to the judgmental nature of managementâs estimates, which involves assumptions of the final price to be agreed with the health authorities in France once the drug product is approved in France or otherwise agreement of price in the event of no approval in France, as not all conditions are known at the time of sale. Managementâs assumptions are based on available relevant market information regarding average treatment cost of the most comparable drugs possible in the rare disease area in Europe. The Company is operating within rare disease therapeutic area where there is unmet treatment need and hence a limited number of comparable commercialized drugs products. The limited available relevant market information for directly comparable commercialized drugs within rare deceases increases the uncertainty in managements estimate. How our audit addressed the key audit matter Our procedures included, among others, checking clerical accuracy of managementâs calculation of liabilities for clawback. We assessed the assumptions applied by management and compared them with the conditions laid out in the Early Access Programs in France. We reperformed procedures on managementâs compilation of available relevant market information regarding average treatment cost of the most comparable drugs possible inthe rare disease area in Europe. Further, we examined subsequent settlement obligations to assess completeness and accuracy of the recorded liabilities, including obtaining the sales contract with KemPharm, and validating the transfer of clawback liability to KemPharm at the carrying amount subsequently to the balance sheet date. In addition, we have assessed the adequacy of the Companyâs disclosures on clawback liabilities related to the matter described above. </arr:KeyAuditMattersAudit>
<arr:StatementOnManagementsReviewAuditorsReportOnAuditedFinancialStatements contextRef="ctx-1" id="pp-value-35" xml:lang="en">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 reviewand, 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="pp-value-36" xml:lang="en">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 andusing 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 todo so. </arr:StatementOfExecutiveAndSupervisoryBoardsResponsibilityForFinancialStatements>
<arr:StatementOfAuditorsResponsibilityForAuditAndAuditPerformed contextRef="ctx-1" id="pp-value-37" xml:lang="en">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 fraudor error, design and perform audit procedures responsive to those risks and obtain audit evidence that issufficient and appropriate to provide a basis for our opinion. The risk of not detecting a materialmisstatement resulting from fraud is higher than for one resulting from error, as fraud may involvecollusion, 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 thatare appropriate in the circumstances, but not for the purpose of expressing an opinion on the effectivenessof the Group's and the Parent Company's internal control.⢠Evaluate the appropriateness of accounting policies used and the reasonableness of accounting estimatesand related disclosures made by Management.⢠Conclude on the appropriateness of Management's use of the going concern basis of accounting inpreparing the financial statements and, based on the audit evidence obtained, whether a materialuncertainty exists related to events or conditions that may cast significant doubt on the Group's and theParent 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 financialstatements or, if such disclosures are inadequate, to modify our opinion. Our conclusions are based onthe audit evidence obtained up to the date of our auditor's report. However, future events or conditionsmay 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 notedisclosures, and whether the financial statements represent the underlying transactions and events in amanner that gives a true and fair view.⢠Obtain sufficient appropriate audit evidence regarding the financial information of the entities or businessactivities within the Group to express an opinion on the consolidated financial statements. We areresponsible for the direction, supervision and performance of the group audit. We remain solelyresponsible 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 threatsor 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 or when, in extremely rare circumstances, we determine that a matter should not be communicated in our report because the adverse consequences of doing so would reasonably be expected to outweigh the public interest benefits of such communication. </arr:StatementOfAuditorsResponsibilityForAuditAndAuditPerformed>
<arr:AuditorsReportOnXbrlTagging contextRef="ctx-1" id="pp-value-39" xml:lang="en">As part of our audit of the financial statements of Orphazyme A/S we performed procedures to express anopinion on whether the annual report for the financial year 1 January â 31 December 2021 with the file name 54930025OZD2GGSQ7L42-2021-12-31-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. 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 taxonomyand the anchoring thereof to elements in the taxonomy, for financial information required to be taggedusing judgement where necessary;⢠Ensuring consistency between iXBRL tagged data and the Consolidated Financial Statements presentedin human readable format; and⢠For such internal control as Management determines necessary to enable the preparation of an annualreport 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 thetagging process;⢠Evaluating the completeness of the iXBRL tagging of the Consolidated Financial Statements;⢠Evaluating the appropriateness of the companyâs use of iXBRL elements selected from the ESEFtaxonomy and the creation of extension elements where no suitable element in the ESEF taxonomy hasbeen 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 for the financial year 1 January â 31 December 2021 with the file name 54930025OZD2GGSQ7L42-2021-12-31-en is prepared, in all material respects, in compliance with the ESEF Regulation. </arr:AuditorsReportOnXbrlTagging>
<cmn:NameOfAuditFirm contextRef="ctx-2" id="pp-value-43" xml:lang="en">EY Godkendt Revisionspartnerselskab</cmn:NameOfAuditFirm>
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<cmn:NameAndSurnameOfAuditor contextRef="ctx-2" id="pp-value-40" xml:lang="en">Christian Schwenn Johansen</cmn:NameAndSurnameOfAuditor>
<cmn:DescriptionOfAuditor contextRef="ctx-2" id="pp-value-41" xml:lang="en">State Authorised Public Accountant </cmn:DescriptionOfAuditor>
<cmn:NameAndSurnameOfAuditor contextRef="ctx-3" id="pp-value-44" xml:lang="en">Anders Roe Eriksen</cmn:NameAndSurnameOfAuditor>
<cmn:DescriptionOfAuditor contextRef="ctx-3" id="pp-value-45" xml:lang="en">State Authorised Public Accountant </cmn:DescriptionOfAuditor>
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