← Back to PRQR filing summaryOriginal filing text · Part I
Item 5 — Management's Discussion and Analysis
Proqr Therapeutics N.v. · 20-F · FY 2025 · Period ended Dec 31, 2025
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You should read the following discussion and analysis of our financial condition and results of operations together with our audited financial statements, including the notes thereto, included elsewhere in this Annual Report. The following discussion is based on our financial statements prepared in accordance with IFRS as issued by the IASB which might differ in material respects from GAAP in the United States. In addition to historical financial information, the following discussion and analysis includes forward-looking statements that involve risks, uncertainties and assumptions. See “Cautionary Note Regarding Forward-Looking Statements.” Our actual results and timing may differ materially from those anticipated in these forward-looking statements as a result of many factors, including but not limited to those described under Item 3.D: “Risk Factors” and elsewhere in this Annual Report.
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A. Operating Results
Overview
To date, we have financed our operations primarily through our initial public and follow-on offerings, and private placements of equity securities, convertible loans, licensing and research collaborations and to a lesser extent through funding from patient organizations and governmental bodies, such as Rijksdienst voor Ondernemend Nederland (“RVO”).
In December 2022, the Company issued 9,381,586 shares to Lilly pursuant to the amended and restated licensing and research collaboration between the Company and Lilly, resulting in gross proceeds of € 14,122,000, with no significant transaction costs. In February 2023, ProQR also received an upfront payment of € 56,412,000.
In September 2024, the Company filed a shelf registration statement on Form F-3, which permitted: (a) the offering, issuance and sale by the Company of up to a maximum aggregate offering price of $ 300,000,000 of its ordinary shares, warrants and/or units, and (b) as part of $ 300,000,000, the issuance and sale by the Company of up to a maximum aggregate offering price of $ 75,000,000 of its ordinary shares that may be issued and sold under a sales agreement (the “sales agreement”) with Cantor Fitzgerald & Co. (“Cantor”) in one or more at-the-market (“ATM”) offerings. The Company will pay Cantor a commission equal to 3% of the gross proceeds of the sales price of all ordinary shares sold through Cantor as sales agent under the sale agreement. As of December 31, 2025, no shares have been issued pursuant to this ATM facility.
In October 2024, the Company consummated an underwritten public offering of 18,000,000 ordinary shares (the “Offering”) at a public offering price of $ 3.50 per share (the “public offering price”). In addition, the Company granted the underwriters a 30-day option to purchase up to 2,700,000 additional ordinary shares at the public offering price, less underwriting discounts and commissions. The option was partially exercised on October 31, 2024, resulting in the issuance of 1,940,072 shares. The gross proceeds from the Offering and subsequent partial exercise of the underwriters’ option, amounted to $ 69,790,000 (€ 64,600,000) while the transaction costs amounted to approximately € 4,365,000, resulting in net proceeds of approximately € 60,235,000.
Concurrently with the Offering, the Company entered into a share purchase agreement with Lilly in a separately negotiated transaction (the “concurrent private placement”), pursuant to which the Company agreed to offer and sell, and Lilly agreed to purchase, 3,523,538 ordinary shares at a price per share equal to the public offering price, for total gross proceeds of approximately $ 12,300,000, subject to a purchase price cap of $ 15,000,000, the consummation of the Offering and the satisfaction of other customary closing conditions. The proceeds of $ 12,300,000 (€ 11,400,000) from the concurrent private placement were received on October 25, 2024. The ordinary shares purchased in the concurrent private placement are not subject to any underwriting discounts or commissions.
In December 2024, we announced an expansion of our research partnership with RSRT. Building on the initial $ 1.0 million research grant announced in January 2024, the expanded partnership includes an additional $ 8.2 million in funding from RSRT, for a total of $ 9.2 million. As part of the expanded partnership, the Company issued warrants to RSRT to purchase up to 2,144,772 ordinary shares at a fixed price of $ 3.73.
At December 31, 2025, we had cash and cash equivalents of € 92,413,000. In 2025, our revenues consist of non-refundable upfront fees and milestone payments in connection with collaboration and license agreements. To date, we have not generated any revenues from royalties or product sales. Based on our current plans, we do not expect to generate royalty or product revenues for the foreseeable future.
We have generated losses since our inception in February 2012. For the years ended December 31, 2025, 2024 and 2023, we incurred net losses of € 42,184,000, € 27,763,000, and € 27,735,000, respectively. At December 31, 2025, we had an accumulated deficit of € 467,506,000. We expect to continue incurring losses for the foreseeable future as we invest in our Axiomer platform and continue our preclinical studies of our product candidates.
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Recent Accounting Pronouncements
There are no IFRS standards as issued by the IASB or interpretations issued by the IFRS interpretations committee that are effective for the first time for financial years beginning on or after January 1, 2025 that had a material impact on our financial statements.
A number of new standards, amendments to standards and interpretations are effective for annual periods beginning on January 1, 2026 and have not been applied in preparing these consolidated financial statements. None of these are expected to have a material impact on the Company in the current or future reporting periods and on foreseeable future transactions. The Company does not plan to adopt these standards early.
On January 1, 2027, IFRS 18 Presentation and Disclosure in Financial Statements will replace IAS 1 Presentation of Financial Statements and is required to be implemented retrospectively. The new standard revises the structure and presentation of the primary financial statements, introduces enhanced aggregation and disaggregation requirements, and requires additional disclosures for Management-Defined Performance Measures (“MPMs”). The Company is continuing to assess the impact of this new standard and based on our initial assessment we do not expect the adoption of IFRS 18 to have a material impact outside the above mentioned changes which may or may not be material. We do not plan to early adopt this standard.
Foreign Private Issuer Exemptions
As a foreign private issuer, we are not subject to the same requirements that are imposed upon U.S. domestic issuers by the SEC. Under the Exchange Act, we will be subject to reporting obligations that, in certain respects, are less detailed and less frequent than those of U.S. domestic reporting companies. For example, although we intend to report our financial results on a quarterly basis, we will not be required to issue quarterly reports, proxy statements that comply with the requirements applicable to U.S. domestic reporting companies, or individual executive compensation information that is as detailed as that required of U.S. domestic reporting companies. We will also have four months after the end of each fiscal year to file our annual reports with the SEC and will not be required to file current reports as frequently or promptly as U.S. domestic reporting companies. We may also present financial statements pursuant to IFRS instead of pursuant to U.S. GAAP. These exemptions and leniencies will reduce the frequency and scope of information and protections available to you in comparison to those applicable to a U.S. domestic reporting companies. Furthermore, our senior management, directors and principal shareholders are exempt from the short-swing profit liability provisions contained in Section 16 of the Exchange Act.
Financial Operations Overview
Revenue
Revenues to date have consisted principally of non-refundable upfront fees and research and development service fees in connection with collaboration and license agreements.
Other Income
Other income mainly consists of the net proceeds from the Company’s divestment of its late-stage ophthalmic intellectual property assets, sepofarsen and ultevursen, to Théa, and grant income from government-related organizations and charities. (Government) Grants are recognized in other income in the same period in which the related research and development expenses are recognized.
Research and Development Expenses
Research and development expenses consist principally of:
● salaries for research and development staff and related expenses, including social security costs and share-based compensation expenses;
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● costs related to our preclinical and clinical activities and trials, including costs paid to CROs;
● costs for production of (pre-)clinical compounds and drug substances by contract manufacturers, including supporting studies such as stability studies and other analysis of the compounds;
● costs of related facilities, materials and equipment; and
● depreciation of tangible fixed assets used to develop our product candidates.
Our research and development expenses in 2025, 2024 and 2023 primarily related to the following key programs:
● Axiomer
Research and development expenses relating to our Axiomer platform, including expenses relating to the work performed under our research and collaboration agreement with Lilly, primarily consist of salaries, costs for production of the preclinical compounds and costs paid to CROs for our preclinical studies. Other significant costs are our internal laboratory costs, including laboratory consumables and allocated housing expenses, as well as consultancy costs in support of our research and development activities for Axiomer.
● Sepofarsen for the treatment of LCA
In 2022 and 2021, the research and development costs relating to sepofarsen primarily consisted of salaries and costs paid to CROs for clinical studies, including statistical analyses, and manufacturing of process performance qualification drug substance batches as well as (pre-)commercial drug product batches. Other significant costs are our internal laboratory costs, including the materials used in the labs and rent allocated to the lab space, as well as consultancy costs in support of our research and development activities. In 2023, costs related to sepofarsen were limited and since 2024 no costs were incurred.
● Ultevursen for the treatment of Usher syndrome
In 2022 and 2021, the research and development costs relating to ultevursen primarily consisted of salaries, costs paid to CROs for managing the clinical study, costs for statistical analyses and manufacturing of process performance qualification drug substance batches. Other significant costs are our internal laboratory costs, including the materials used in the labs and rent allocated to the lab space, as well as consultancy costs in support of our research and development activities. In 2023, costs related to ultevursen were limited and since 2024 no costs were incurred.
Our research and development expenses may vary substantially from period to period based on the timing of our research and development activities. Research and development expenses are expected to increase as we continue our joint research projects with Lilly and our investments in the Axiomer platform, while progressing our internal pipeline targets towards clinical development.
Changes in internal or external variables with respect to the development of our Lilly collaboration program and the development of our Axiomer platform and resulting product candidates could result in a significant change in the costs and/or timing associated with the development of such product candidates. For example, if the FDA, EMA or other regulatory authority were to require us to conduct preclinical and clinical studies beyond those which we currently anticipate, or if we experience significant delays in enrollment in any future clinical trials, we could be required to expend significant additional financial resources and time on the completion of our development programs.
General and Administrative Expenses
Our general and administrative expenses consist principally of:
● salaries for employees other than research and development staff and related expenses, including social security costs and share-based compensation expenses;
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● professional fees for auditors and other consulting expenses not related to research and development activities;
● professional fees for lawyers;
● cost of facilities, communication and office expenses;
● IT expenses; and
● depreciation of property, plant and equipment not related to research and development activities.
Since our IPO in September 2014 we have incurred additional costs associated with operating as a public company. These public company-related expenses include costs of additional personnel, additional legal fees, accounting and audit fees, board of directors’ liability insurance premiums and costs related to investor relations. We expect that our general and administrative expenses will remain fairly stable in upcoming years.
Share-Based Compensation
Share-based compensation reflects the costs of our equity-settled share option plan, which are measured at the fair value of the options and restricted stock units at the grant date, and which are recognized over the course of each of the separate vesting tranches of the applicable vesting period of the options and restricted stock units involved. The share-based compensation is recognized in the income statement, with a corresponding entry to the equity-settled employee benefits reserve, which is part of equity. See Note 12(d) to the financial statements included elsewhere in this Annual Report for additional information on share-based compensation.
Financial Income and Expense
To date, our cash and cash equivalents have been deposited primarily in savings, short-term deposit accounts, and money market funds which generate interest income. In 2025, 2024 and 2023 we held deposits in both euro and U.S. dollars.
Financial expenses primarily consist of interest expenses on convertible loans and government loans. Financial income and expense also includes foreign exchange gains or losses on our U.S. dollar denominated cash and cash equivalents and other foreign currency denominated monetary items.
Results related to derecognition of financial liabilities
Results related to derecognition of financial liabilities represent gains or losses arising from the extinguishment of convertible loans in 2023.
Results related to financial liabilities measured at fair value through profit or loss
Results related to financial liabilities measured at fair value through profit or loss (“FVTPL”) represent changes in the fair value of derivative financial instruments since their initial recognition. In 2025, 2024 and 2023, these derivative financial instruments consist of conversion options and warrants issued in connection with our convertible loans and partnership agreements. The warrants that were part of the original agreement with convertible loan issuers expired during 2025 and have been derecognized. The remaining warrants as part of the amended agreement with the convertible loan issuers have not yet expired at December 31, 2025 and therefore have not been derecognized. The warrants related to partnership agreements were issued in 2024 and remain outstanding at December 31, 2025.
Income Tax
Due to the operating losses incurred since inception, the Company has no income tax provisions as at December 31, 2025. Realization of deferred tax assets is dependent on future earnings, if any, the timing and amount of which are uncertain. Accordingly, we have not yet recognized any deferred tax asset related to operating losses.
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Results of Operations
Comparison of the periods ended December 31, 2025 and 2024
The following table sets forth our results of operations for the periods indicated.
Year ended December 31,
2025 2024 Change
(€ in thousands)
Revenue 15,906 18,905 (2,999)
Other income 441 640 (199)
Research and development costs (44,733) (36,356) (8,377)
General and administrative costs (15,060) (13,661) (1,399)
Operating result (43,446) (30,472) (12,974)
Financial income 2,333 3,251 (918)
Financial expense (1,287) (1,084) (203)
Results related to financial liabilities measured at FVTPL 235 345 (110)
Corporate income taxes (19) 197 (216)
Net loss (42,184) (27,763) (14,421)
Revenue
In 2025, we realized revenue from our license and research collaboration agreement with Lilly amounting to € 15,906,000 (2024: € 18,905,000). The decrease in Lilly revenue is due to fewer milestones being achieved in 2025 (€ 3,922,000) compared to 2024 (€ 5,096,000) and the finalization of certain targets in 2024, consistent with expected fluctuations as portfolio priorities shift over time.
Other income
In 2025 and 2024, other income consisted primarily of grant income from our RSRT partnership that helps support the advancement of AX-2402, our program for the treatment of Rett syndrome. This partnership consists of two agreements that were entered into in January and December 2024, respectively, and we are eligible to receive up to $ 9.2 million under these agreements. In 2025, we realized other income of € 441,000 (2024: € 640,000). The decrease in other income is due to delays in timelines. As at December 31, 2025 other income related to the initial RSRT agreement has been recognized in full and work has not commenced on the expanded RSRT agreement.
Research and development costs
Research and development costs amounted to € 44,733,000 for the year ended December 31, 2025 compared to € 36,356,000 for the year ended December 31, 2024. These costs were primarily related to the development of our Axiomer platform, including costs incurred under the Lilly collaboration, and investments in our own pipeline targets. Research and development expenses are expected to increase as we continue our joint research projects with Lilly and our investments in the Axiomer platform, while progressing our internal pipeline targets towards clinical development.
Our research and development expenses are highly dependent on the development phases of our product candidates.
The increase in research and development costs in the year ended December 31, 2025, compared to the year ended December 31, 2024, was due to higher outsourced research and development activities related to our joint research projects with Lilly, increased investments in our own pipeline targets and our investments in the Axiomer platform. In addition, in 2025 there was higher allocation of general and administrative costs to research and development costs due to a higher number of employees working in research and development, as compared to 2024.
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General and administrative costs
General and administrative costs amount to € 15,060,000 for the year ended December 31, 2025 and € 13,661,000 for the year ended December 31, 2024. The increase in general and administrative costs in the year ended December 31, 2025 compared to the year ended December 31, 2024 is primarily attributable to increased employee benefits resulting from changes in senior management in 2025.
Financial income
We had financial income of € 2,333,000 for the year ended December 31, 2025, as compared to € 3,251,000 for the year ended December 31, 2024. The financial income mainly reflects interest income earned on cash and cash equivalents in 2025 and 2024.
Financial expenses
Financial expenses amounted to € 1,287,000 for the year ended December 31, 2025, as compared to € 1,084,000 for the year ended December 31, 2024. The increase in 2025 compared to 2024 is mainly due to a larger foreign exchange loss.
Results related to financial liabilities measured at fair value through profit or loss
Results related to financial liabilities measured at FVTPL amounted to a gain of € 235,000 for the year ended December 31, 2025, as compared to a gain of € 345,000 for the year ended December 31, 2024. These results relate to fair value changes in our derivative financial instruments, consisting of issued warrants. The gains in 2025 and 2024 were due to the decrease in the fair value of warrants, mainly due to the decrease in ProQR’s share price.
Comparison of the periods ended December 31, 2024 and 2023
Reference is made to our Annual Report on Form 20-F for the fiscal year ended December 31, 2024, filed with the SEC on March 13, 2024, for a comparison of the periods ended December 31, 2024 and 2023.
B. Liquidity and Capital Resources
To date, we have financed our operations primarily through our initial public and follow-on offerings, our ATM facility and private placements of equity securities, convertible loans, licensing and research collaborations and to a lesser extent through funding from patient organizations and governmental bodies, such as RVO.
Cash and Funding Sources
The table below summarizes our main sources of financing for the years ended December 31, 2025, 2024 and 2023.
Equity Lilly Upfront and
Capital Milestone Payments Total
(€ in thousands)
Year ended December 31, 2023 — 56,412 56,412
Year ended December 31, 2024 71,635 5,096 76,731
Year ended December 31, 2025 — 3,922 3,922
Total 71,635 65,430 137,065
Equity capital
In 2024 our funding consisted of Offering of 18,000,000 ordinary shares and the respective option that resulted in additional issuance of 1,940,072 ordinary shares, at the public offering price of $ 3.50 per share. The gross proceeds from the Offering and subsequent partial exercise of the underwriters’ option, amounted to $ 69,790,000 (€ 64,600,000) while the transaction costs amounted to approximately € 4,365,000, resulting in net proceeds of approximately € 60,235,000.
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Concurrently with the Offering, we entered into the concurrent private placement with Lilly pursuant to which we agreed to offer and sell, and Lilly agreed to purchase, 3,523,538 ordinary shares at a price per share equal to the public offering price. The net proceeds from the concurrent private placement amount to approximately € 11,400,000.
We issued shares in 2022 and 2024. Our share issuances are set out in more detail in Note 12 (a) to the financial statements as included elsewhere in this Annual Report.
As at December 31, 2025 our outstanding shares totaled 105,361,064. The following items may result in future dilution for our shareholders:
● 1,054,010 treasury shares held by the Company, which can be used for all general purposes including option exercises under the equity incentive plan, as amended in May 2024;
● 1,295,842 treasury shares held by the ESOP foundation, which can be used for option exercises under the equity incentive plan, as amended in May 2024;
● 15,804,160 shares authorized for issuance for future grants under the equity incentive plan, as amended in May 2024;
● 376,952 warrants held by former convertible debt holders;
● 2,144,772 warrants held by RSRT.
If all of the above items were converted into shares at December 31, 2025, the number of outstanding shares would be 126,036,800.
Convertible loans and government borrowing
We received convertibles loans and government borrowing in 2021. Our convertible loans and government borrowings are set out in more detail in Note 13 to the financial statements as included elsewhere in this Annual Report.
Lilly upfront and milestone payments
In 2025, our sources of funding included the receipt of milestone payments amounting to $ 4,500,000 (€ 3,922,000) under the collaboration agreement with Lilly (2024: $ 5,500,000 (€ 5,096,000)). In 2023, we received the upfront payments under the collaboration agreement with Lilly, which are reflected in changes in working capital. For more details refer to Note 16 to the financial statements included elsewhere in this Annual Report.
Cash Flows
The table below summarizes our statement of cash flows for the years ended December 31, 2025 and 2024.
Year ended December 31,
2025 2024 Change
(€ in thousands)
Net cash (used in) / generated by operating activities (52,791) (36,393) (16,398)
Net cash (used in) / generated by investing activities (1,020) (4,073) 3,053
Net cash (used in) / generated by financing activities (1,836) 70,276 (72,112)
Net (decrease) / increase in cash and cash equivalents (55,647) 29,810 (85,457)
Currency effect cash and cash equivalents (1,348) 673 (2,021)
Cash and cash equivalents at the beginning of the period 149,408 118,925 30,483
Cash and cash equivalents at the end of the period 92,413 149,408 (56,995)
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Net cash used in operating activities amounted to € 52,791,000 in the year ended December 31, 2025, whereas net cash used in operating activities amounted to € 36,393,000 in the year ended December 31, 2024. Total operating costs increased by € 9,776,000 in 2025 compared to 2024 and changes in working capital increased by € 4,897,000, both of which had a negative impact on net cash generated by operating activities.
Net cash used in investing activities in the year ended December 31, 2025 is mainly driven by purchases of laboratory equipment and other fixed assets of € 1,020,000 (2024: € 1,418,000). In addition, in 2024 ProQR paid the remaining portion of costs of € 2,655,000 related to the transaction with Théa.
Net cash used in financing activities amounted to € 1,836,000 in the year ended December 31, 2025 compared to net cash generated by financing activities amounted to € 70,276,000 in the year ended December 31, 2024. In 2025, net cash used in financing activities included repayments of the lease liability for the Company’s Leiden headquarters amounting to € 1,905,000. In 2024, net cash generated by financing activities consists of the net proceeds from the offering of € 60,235,000 and the share sale to Lilly of € 11,400,000. The cash inflows in 2024 were offset by repayments of the lease liability for the Company’s Leiden headquarters amounting to € 1,582,000.
Reference is made to our Annual Report on Form 20-F for the fiscal year ended December 31, 2024, filed with the SEC on March 13, 2024, for a comparison of the periods ended December 31, 2024 and 2023.
For a description of our financial commitments, see below.
Funding Requirements
Our material cash requirements from known contractual and other obligations include contractual commitments to repay borrowings, lease liabilities, and trade and other payables. In 2026, such cash requirements include the following undiscounted amounts:
● Borrowings amounting to € 5,162,000
● Lease liabilities amounting to € 1,978,000
● Trade and other payables amounting to € 8,238,000
Beyond 2026, our cash requirements include the following undiscounted amounts:
● Lease liabilities amounting to € 10,682,000
We expect that our cash and cash equivalents will enable us to fund our operating expenses and capital expenditure requirements into mid-2027. We have based this estimate on assumptions that may prove to be wrong, and we could use our capital resources sooner than we currently expect. Our present and future funding requirements will depend on many factors, including, among other things:
● the investments required to further develop our Axiomer platform and the results of current and potential future collaborations involving the Axiomer technology.
● the progress, timing, resumption and completion of preclinical testing and clinical trials for our current or any future product candidates;
● the number of potential new product candidates we identify and decide to develop;
● the costs involved in growing our organization to the size needed to allow for the research, development and potential commercialization of our current or any future product candidates;
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● the costs involved in filing patent applications and maintaining and enforcing patents or defending against claims or infringements raised by third parties;
● the time and costs involved in obtaining regulatory approval for our product candidates and any delays we may encounter as a result of evolving regulatory requirements or adverse results with respect to any of these product candidates;
● any licensing or milestone fees we might have to pay during future development of our current or any future product candidates;
● the amount of revenues, if any, we may derive from upfront, milestone or royalty payments resulting from licensing and research collaboration agreements.
Our ability to execute our operating plans and access additional capital may be affected by a variety of factors, including market conditions, regulatory developments, and stockholder actions. For more information as to the risks associated with our future funding needs, see Item 3.D: “Risk Factors”.
Capital Expenditures
The following table sets forth our capital expenditures for the years ended December 31, 2025, 2024 and 2023:
Year ended December 31,
2025 2024 2023
(€ in thousands)
Purchases of property, plant and equipment 1,020 1,418 1,371
Purchases of property, plant and equipment primarily consist of investments in laboratory equipment. Such investments decreased in 2025 compared to 2024 as the investments of the Company were focused on outsourced research and development activities instead of its in-house oligonucleotide manufacturing capacity.
Commitments
Our commitments consist of rent, patent license agreements, clinical support agreements, research and development commitments.
Refer to Notes 25 and 26 to the financial statements as included elsewhere in our Annual report and Item 4.B: “Business Overview” for more details on our commitments.
C. Research and Development
See Item 4.B: “Business Overview” and Item 5: “Operating and Financial Review and Prospects”.
D. Trend Information
Other than as disclosed elsewhere in this Annual Report, we are not aware of any trends, uncertainties, demands, commitments or events for the period from January 1, 2025 to December 31, 2025 that are reasonably likely to have a material adverse effect on the Company’s net income, profitability, liquidity or capital resources, or that caused the reported financial information to be not necessarily indicative of future operating results or financial conditions. For a discussion of trends, see Item 5.A: “Operating results”.
E. Critical Accounting Policies and Significant Judgments and Estimates
Our management’s discussion and analysis of our financial condition and results of operations is based on our financial statements, which we have prepared in accordance with IFRS as issued by the IASB. The preparation of these financial
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statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of the financial statements, as well as the reported revenues and expenses during the reporting periods. Actual results may differ from these estimates under different assumptions or conditions. There have been no material adjustments to prior period estimates for any of the periods included in this Annual Report. Significant estimates and judgements are disclosed in disclosure Note 2 Basis of preparation to the financial statements, under (e) Use of estimates and judgements.
Our significant accounting policies are fully described in the notes to our financial statements appearing elsewhere in this Annual Report.