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2025-02-13 08:00:00 CET 2025-02-13 08:00:21 CET REGULATED INFORMATION Optomed Oyj - Financial Statement ReleaseOptomed Plc: Financial Statements Bulletin, January - December 2024Optomed Plc Stock Exchange Release 13 February 2025 at 9.00, Helsinki Optomed Plc: Financial Statements Bulletin, January - December 2024 October - December 2024 Revenue increased by 39.3 percent to EUR 5.1 (3.7) million Devices segment revenue increased by 149.3 percent to EUR 2.6 (1.0) million driven by a large order in the US. Software segment revenue decreased by 3.3 percent to EUR 2.5 (2.6) million. Adjusted EBITDA was EUR -0.5 (-0.8) million corresponding to -10.4 (-20.7) percent of revenue. Optomed expects its full year 2025 revenue to grow strongly compared to 2024 January - December 2024 Revenue decreased by 0.4 percent to EUR 15.0 (15.1) million. Devices segment revenue increased by 6.3 percent to EUR 5.3 (5.0) million. Software segment revenue decreased by 3.7 percent to EUR 9.7 (10.1) million. Adjusted EBITDA amounted to EUR -2.8 (-1.5) million corresponding to -18.6 ( -9.7) percent of revenue and EBITDA amounted to -3.5 (-1.8) EUR million. Optomed Aurora with AEYE-DS AI successfully received FDA clearance in Q2-2024. Optomed signed a shareholder's agreement with (https://tools.eurolandir.com/tools/Pressreleases/GetPressRelease/?ID=5190328&la ng=en-GB&companycode=sf -opto&v=)Zhongbao (https://tools.eurolandir.com/tools/Pressreleases/GetPressRelea se/?ID=5190328&lang=en-GB&companycode=sf-opto&v=) Fund to establish a joint venture in China (https://tools.eurolandir.com/tools/Pressreleases/GetPressRelease/?ID=51903 28&lang=en-GB&companycode=sf-opto&v=) in Q2-2024. Optomed successfully completed directed share issue in Q2-2024 raising gross proceeds approximately EUR 7.9 million. Key figures In thousands of euro Q4/2024 Q4/2023 Change, % 2024 2023 Change, % Revenue 5,099 3,660 39.3% 15,040 15,100 -0.4% Gross profit * 3,321 2,489 33.4% 9,676 10,292 -6.0% Gross margin % * 65.1% 68.0 % 64.3% 68.2% EBITDA -812 -757 -7.2% -3,458 -1,781 -94.2% EBITDA margin *, % -15.9% -20.7% -23.0% -11.8% Adjusted EBITDA * -532 -757 29.7% -2,796 -1,470 -90.2% Adjusted EBITDA margin -10.4% -20.7% -18.6% -9.7% *, % Operating result -1,497 -1,319 -13.5% -5,689 -3,974 -43.2% (EBIT) Operating margin -29.4% -36.1% -39.6% -26.3% (EBIT) *, % Adjusted operating -1,218 -1,319 7.7% -5,295 -3,663 -44.6% result (EBIT) * Adjusted operating -23.9% -36.1% -35.2% -24.3% margin (EBIT margin) *, % Net profit/ loss -989 -1,530 35.5% -5,450 -4,441 -22.7% Earnings per share -0.05 -0.09 42.1% -0.29 -0.27 -9.8% Cash flow from 318 -457 169.5% -1,596 -615 -159.3% operating activities Net Debt -8,170 -3,768 116.8% -8,170 -3,768 116.8% Net debt/ EBITDA (LTM) 2.4 2.1 2.4 2.1 * Net debt/ Adjusted 2.9 2.6 2.9 2.6 EBITDA (LTM) * Equity ratio * 74.4% 70.0% 74.4% 70.0% R&D expenses personnel 394 338 16.7% 1,336 1,280 4.4% R&D expenses other 223 139 60.7% 706 644 9.6% costs Total R&D expenses 617 476 29.5% 2,041 1,924 6.1% *) Alternative performance measures, see section Alternative Performance Measures for definitions and calculations. Optomed presents Adjusted EBITDA and Adjusted operating result as alternative performance measures to enhance comparability of business performance between reporting periods. In FY2024 items affecting comparability amounted to EUR 662 thousand and In Q4 2024 items affecting comparability amounted to 279 and are related to credit loss with respect to an overdue trade receivable from a customer in China. CEO Review Dear Shareholders I am pleased to present Optomed's financial and operational results for the fourth quarter and full year 2024. This has been a year of both challenges and significant achievements as we continue to drive innovation and expand our market presence. Despite macroeconomic headwinds, we have made important progress in our strategic initiatives, particularly in the U.S. October - December 2024 Optomed delivered strong growth in the fourth quarter of 2024, with revenue increasing by 39.3% to EUR 5.1 million, compared to EUR 3.7 million in the same period of 2023. This growth was primarily driven by the significant increase in the Devices segment, which saw revenue surge by 149.3% to EUR 2.6 million (Q4 2023: EUR 1.0 million). A key driver of this growth was a large order from the U.S., reflecting the increasing demand for our innovative handheld fundus cameras in the market. In contrast, revenue in the Software segment declined slightly by 3.3% to EUR 2.5 million (Q4 2023: EUR 2.6 million). While we continue to see strong engagement from our existing customers, the segment faced temporary challenges related to contract renewals and delayed purchasing decisions by some clients. Optomed's Adjusted EBITDA improved compared to the previous year, amounting to EUR -0.5 million (Q4 2023: EUR -0.8 million). This represents an improvement in profitability, with Adjusted EBITDA margin rising to -10.7%, compared to -20.7% in Q4 2023. The improvement was driven by higher revenue from the Devices segment, operational efficiency measures, and disciplined cost control. January - December 2024 For the full year 2024, Optomed's revenue remained stable, decreasing slightly by 0.4% to EUR 15.0 million (2023: EUR 15.1 million). While overall growth was limited, the performance varied across our two main business segments. Devices segment revenue increased by 6.3% to EUR 5.3 million (2023: EUR 5.0 million), driven by strong demand in the U.S. The US has become our largest market within the Devices segment in 2024. Software segment revenue declined by 3.7% to EUR 9.7 million (2023: EUR 10.1 million). The decrease was mainly due to slower-than-expected contract renewals, but we anticipate a recovery in 2025 especially in the dental business which a new business segment for Optomed. Optomed's profitability was impacted by investments in growth, leading to an Adjusted EBITDA of EUR -2.8 million (2023: EUR -1.5 million), corresponding to -18.7% of revenue (2023: -9.7%). The decline reflects our strategic investments in AI-driven technology, regulatory approvals, and market expansion initiatives, which we expect to yield long-term benefits. Key Achievements in 2024 · FDA clearance for Optomed Aurora together with our partner AEYE Health: one of our most significant achievements in 2024 was successfully obtaining FDA clearance for Optomed Aurora with AEYE-DS AI in Q2. This marks a major milestone as Optomed Aurora AEYE became the first AI-powered handheld fundus camera to receive FDA clearance for detecting diabetic retinopathy. This clearance opens new opportunities in the U.S. market, reinforcing our leadership in AI-driven eye diagnostics. · Our new fundus camera successfully received CE certification according to new regulation (MDR). This device will be a game-changing component in the field of oculomics´s expansion and breakthrough in the field. · Strategic Expansion in China: In Q2 2024, Optomed signed a shareholder agreement with Zhongbao Fund to establish a joint venture in China. · We successfully entered into the dental imaging segment for several major well-being services counties. This marks an opportunity for us and provides a strong foundation for future growth. We also managed to secure continuation for our non-healthcare-related business. This business has been in the past years a significant part of software segments overall business. · Successful fundraising: To support our growth strategy, Optomed successfully completed a directed share issue in Q2 2024, raising gross proceeds of approximately EUR 7.9 million. This funding has provided us with additional resources to advance our AI technology, expand into new markets, and invest in product innovation. Our cash position remains strong at the year end of 2024 and this enables us to drive our key growth initiatives forward. Year 2025 Looking ahead to 2025, Optomed remains committed to its mission of making eye screening accessible and efficient worldwide. Among others, we expect the following items to support our revenue growth in 2025: · Increased adoption of AI-powered screening solutions, particularly in the U.S. following the FDA clearance. · New partnerships and collaborations with healthcare providers and research institutions. · Continued innovation and investment in AI and handheld imaging technology. We are confident that our strong foundation, strategic initiatives, and commitment to innovation will drive sustainable growth and improved profitability in the years ahead. I would like to take this opportunity to thank our employees, customers, partners, and shareholders for their continued trust and support. Together, we are shaping the future of AI-powered eye diagnostics. Juho Himberg CEO Outlook 2025 Optomed expects its full year 2025 revenue to grow strongly compared to 2024. Telephone conference A telephone conference for analysts, investors and media will be arranged on 13 February 2024 at 11.00 EET, (10.00 CET). The event will be held in English. The presentation material will be available at www.optomed.com/investors 10.00 EET at the latest. The participants are requested to register for the call-in advance by email to sakari.knuutti@optomed.com. Please see the call-in numbers below: FI +358 9 856 263 00 SE +46 8 505 218 52 UK +44 20 3321 5273 US +1 646 838 1719 FR +33 1 70 99 53 92 The conference id is 902 596 758# Please note that by dialing into the conference call, the participant agrees that personal information such as name and company name will be collected. Group performance October - December 2024 In October-December 2024, the group's revenue increased by 39.3 percent to EUR 5,099 (3,660) thousand. Revenue in the Devices segment increased by 149.3 percent to EUR 2,551 (1,023) thousand due to a large order in the United States. Revenue in the Software segment decreased by 3.3 percent to EUR 2,549 (2,637) thousand. The gross margin decreased to 57.9 percent from 68.0 percent in the comparison period. EBITDA decreased to EUR -812 (-757) thousand. EBIT was EUR -1,497 (-1,319) thousand. Net financial items for October-December 2024 were EUR 493 (-230) thousand, mainly consisting of interest income and exchange rate differences between the Chinese renminbi and the US dollar against the euro. January - December 2024 In January-December, revenue decreased by 0.4 percent to EUR 15,040 (15,100) thousand. Revenue in the Devices segment increased by 6.3 percent, while revenue in the Software segment decreased by 3.7 percent. The gross margin decreased to 64.3 percent from 68.2 percent in the comparison period. EBITDA was EUR -3,458 (-1,781) thousand, and EBIT was EUR -5,957 (-3,974) thousand. Net financial items were EUR 441 (-545) thousand, mainly consisting of interest income and exchange rate differences between the Chinese renminbi and the euro. Optomed Aurora AEYE-DS AI successfully received FDA approval in the United States during Q2 2024. In Q2 2024, Optomed signed a shareholder agreement for a joint venture in China with Zhongbao, a venture capital firm based in Shenzhen, China. The pilot project has been transferred to 2025. Cash flow and financial position October - December 2024 In October-December, the net cash flow from operations was EUR 318 (-457) thousand. The net cash flow from investments was EUR -613 (-583) thousand, mainly consisting of capitalized product development expenses. The net cash flow from financing activities was EUR -241 (-1,415) thousand for the financial year. At the end of the review period, the group's cash and cash equivalents were EUR 10,467 (7,118) thousand. Net debt was EUR -8,170 (-3,768) thousand at the end of the review period. Net working capital was EUR 1,128 (2,460) thousand at the end of the review period. A Chinese customer, from whom Optomed has significant trade receivables, has failed to make several payments since the second half of 2023. The credit loss provision has been increased by EUR 279 thousand in Q4 and it was now 100% of the trade receivable at the end of the review period. Optomed will nevertheless continue to pursue debt collection. January - December 2024 In January-December, the net cash flow from operations was EUR -1,596 (-615) thousand. The net cash flow from investments was EUR -2,118 (-2,412) thousand, mainly consisting of capitalized product development expenses. A Chinese customer, from whom Optomed has significant trade receivables, has failed to make several payments since the second half of 2023. As a result, the special provision for credit losses was increased to 75 percent during Q2 2024. During Q3 2024, Optomed received a payment of EUR 455 thousand from the customer, reducing the credit loss provision by EUR 340 thousand. The credit loss provision was increased to 100% in the last quarter of the year and the trade receivable has been written off. Total credit loss for 2024 was EUR 1,099 thousand. The net cash flow from financing activities was EUR 7,081 (1,609) thousand for the review period. On June 26, 2024, Optomed carried out a directed share issue consisting of 1,500,000 new shares of the company. The issue raised approximately EUR 7.9 million in gross proceeds. Devices segment Optomed has two synergistic business segments: Devices and Software. The Devices segment develops, commercializes, and manufactures easy-to-use, and affordable handheld fundus cameras, that are suitable for any clinic for screening of various eye diseases, such as diabetic retinopathy, glaucoma and AMD (Age Related Macular Degeneration). In thousands Q4/2024 Q4/2023 Change, % 2024 2023 Change, % of euro Revenue 2,551 1,023 149.3% 5,326 5,009 6.3% Gross profit * 1,476 590 150.2% 2,778 2,947 -5.7% Gross margin % 57.9% 57.7% 52.2% 58.8% * EBITDA -115 -570 126.7% -1,673 -1,264 -32.4% EBITDA margin -4.5% -55.7% -31.4% -25.2% *, % Operating -589 -938 65.8% -3,343 -2,707 -23.5% result (EBIT) Operating -231% -91.7% -62.8% -54.0% margin (EBIT) *, % *) Alternative performance measures, see section Alternative Performance Measures for definitions and calculations. October - December 2024 In October - December 2024, the Devices segment revenue increased by 149.3 percent to EUR 2,551 (1,023) thousand. During the quarter, the Devices segment received a large order from a US screening service provider. The order was traditional device capex transaction and did not include AI service or a recurring revenue component. The gross margin was 57.9 (57.7) percent. EBITDA was EUR -115 (-570) thousand or -4.5 (-55.7) percent of revenue. January - December 2024 In January - December 2024, the Devices segment revenue increased by 6.3 percent to EUR 5,326 (5,009) thousand. During the year, the US was the largest sales channel driven by the large US order of Q4. The gross margin decreased to 52.2 percent from 58.8 percent. The gross margin was negatively affected by an inventory revaluation of EUR 0.3 million in Q3 -2024. EBITDA was EUR -1,673 (-1,264) thousand or -31.4 (-25.2) percent of revenue. Software segment Optomed has two synergistic business segments: Devices and Software. The Software segment develops and commercializes screening software for diabetic retinopathy and cancer screening for healthcare organizations. The segment also distributes off-the-shelf products from selected partners to supplement its own solutions and expertise and provides software consultation to support the Devices segment screening solution projects. In thousands Q4/2024 Q4/2023 Change, % 2024 2023 Change, % of euro Revenue 2,549 2,637 -3.3% 9,714 10,091 -3.7% Gross profit * 1,845 1,899 -2.8% 6,889 7,346 -6.2% Gross margin % 72.4% 72.0% 70.9 % 72.8% * EBITDA 429 624 -31.2% 1,897 2,629 -27.8% EBITDA margin 16.8% 23.7% 19.5 % 26.1% *, % Operating 219 432 -49.3% 1,078 1,889 -42.9% result (EBIT) Operating 8.6% 16.4% 11.1 % 18.7% margin (EBIT) *, % *) Alternative performance measures, see section Alternative Performance Measures for definitions and calculations. October - December 2024 In October - December 2024, the Software segment decreased by 3.3 percent to EUR 2,549 (2,637) thousand. The gross margin was 72.4 (72.0) percent. EBITDA was EUR 429 (624) thousand or 16.8 (23.7) percent of revenue. January - December 2024 In January - December 2024, the Software segment revenue decreased by 3.7 percent to EUR 9,714 (10,091) thousand. In Q3-2024, the Software segment won a dental imaging related public procurement process in Finland In Q2-2024, Optomed won a contract to provide non-healthcare development services to a Finnish governmental agency. Optomed has been providing the services since 2003, but the contract was subject to a procurement process. Gross margin decreased and it was 70.9 (72.8) percent. EBITDA was EUR 1,897 (2,629) thousand or 19.5 (26.1) percent of revenue. Group-wide expenses Group-wide expenses relate to functions supporting the entire group such as treasury, group accounting, marketing, legal, HR, and IT. October - December 2024 Group-wide operating expenses amounted to EUR 1,127 (814) thousand. January - December 2024 Group-wide operating expenses amounted to EUR 3,692 (3,155) thousand. Personnel Number of personnel at the end of the reporting period. 12/2024 12/2023 Devices 47 47 Software 50 47 Group common 18 20 Total 115 114 Corporate Governance Optomed complies with Finnish laws and regulations, Optomed's Articles of Association, the rules of Nasdaq Helsinki and the Finnish Corporate Governance Code 2020 issued by the Securities Market Association of Finland. The code is publicly available at http://cgfinland.fi/en/. Optomed's corporate governance statement 2023 is available on the company website www.optomed.com/investors/. Annual General Meeting The Annual General Meeting held on 10 May 2024 adopted the financial statements for the financial period ended on 31 December 2023, discharged the members of the Board of Directors and the CEO from liability for the financial period ended on 31 December 2023 and adopted the Company's Remuneration Report and Remuneration Policy for Governing Bodies. The Annual General Meeting resolved in accordance with the proposal of the Board of Directors that no dividend will be paid for the year 2023. The number of members of the Board of Directors was confirmed as six. Catherine Calarco, Ty Lee, Seppo Mäkinen, Petri Salonen, Reijo Tauriainen and Anna Tenstam were re-elected as members of the Board. The Annual General Meeting confirmed the annual Board remuneration as follows: Chairman of the Board EUR 36,000 members of the Board EUR 18,000. In addition, a meeting fee in the amount of EUR 300 is paid to the Chairpersons and EUR 200 to members of the Committees for each Committee meeting. 40 percent of the Board remuneration is paid in Optomed shares and 60 percent in cash. The part of the Board remuneration paid in Optomed shares will, if possible, be conveyed from the treasury shares of the Company in accordance with the authorization of the Board of Directors to resolve on the issuance of shares and special rights entitling to shares. The remuneration will be paid once a year in August, after Optomed's H1 report has been announced. The Annual General Meeting decided to re-elect KPMG Oy Ab, a firm of authorized public accountants, as the Company's auditor. KPMG Oy Ab has informed the Company that Authorized Public Accountant Heidi Hyry acts as the auditor with principal responsibility. The auditor's remuneration will be paid in accordance with an invoice approved by the Company. The Annual General Meeting resolved in accordance with the Board's proposal to amend the terms and conditions of the Stock Option Plans 2017B, 2018C, 2019A and 2019C so that the subscription periods for shares pursuant to all option rights granted under each Stock Option Plan will end on 31 December 2027. The Annual General Meeting approved the authorization for the Board of Directors to repurchase Optomed's own shares and to accept them as pledge. Altogether no more than 1,813,039 shares may be repurchased or accepted as pledge. The authorization will be valid until the earlier of the end of the next Annual General Meeting or 18 months from the resolution of the Annual General Meeting. The Annual General Meeting authorized the Board of Directors to decide on the issuance of shares and other special rights entitling to shares referred to in Chapter 10, Section 1 of the Finnish Companies Act. The number of shares to be issued based on this authorization may not exceed 1,813,039. The Board of Directors is authorized to resolve on all terms and conditions of the issuance of shares and special rights entitling to shares, including the right to derogate from the pre-emptive right of the shareholders. The authorization will be valid until the earlier of the end of the next Annual General Meeting or 18 months from the resolution of this Annual General Meeting. Decisions of the Board of Directors: At its meeting held after the Annual General Meeting, the Board of Directors elected from among its members Petri Salonen as its Chairman. The committee members were elected as follows: Audit Committee: Reijo Tauriainen (Chairman) Catherine Calarco Ty Lee Anna Tenstam Remuneration Committee: Seppo Mäkinen (Chairman) Ty Lee Catherine Calarco Shares and shareholders The Company has one share series with all shares having the same rights. At the end of the review period Optomed Plc's share capital consisted of 19,693,297 shares and the Company held 34,729 shares in the treasury which approximately corresponds to 0.18 percent of the total amount of the shares and votes. Additional information with respect to the shares, shareholding and trading can be found on the Company's website www.optomed.com/investors/. Flagging notifications On 2 July 2024, Optomed announced that has received a notification in accordance with the Chapter 9, Section 5 of the Finnish Securities Markets Act (as amended, the “SMA”) from Sp Rahastoyhtiö Oy. According to the notification, the total holdings in Optomed shares and votes held the investment funds of Sp -Rahastoyhtiö (Säästöpankki Pienyhtiöt, Säästöpankki Kotimaaa) is 6.51 per cent of all of the registered shares in Optomed on 1 July 2024. On 30 September 2024, Optomed announced that it has received a notification in accordance with the Chapter 9, Section 5 of the Finnish Securities Markets Act (as amended, the “SMA”) from Danske Bank A/S. According to the notification, the total holdings in Optomed shares and votes held by Danske Bank A/S is 5.08 per cent of all of the registered shares in Optomed on 26 September 2024. On 14 November 2024, Optomed announced that it has received a notification in accordance with the Chapter 9, Section 5 of the Finnish Securities Markets Act (as amended, the “SMA”) from Danske Bank A/S. According to the notification, the total holdings in Optomed shares and votes held the by Danske Bank A/S is 4.86 per cent of all of the registered shares in Optomed on 12 November 2024. Directed share issue Optomed completed a directed share issue consisting of 1,500,000 shares and collected gross proceeds of approximately EUR 7.9 million in June 2024. According to the assessment of the Company, the Share Issue supports the Company's target best compared to other equity financing options. The Board has considered other financing options, including various capital market financing options. According to the assessment of the Board, the other alternatives involved significant costs, timetable requirements as well as uncertainties related to the implementation which are not in the interest of the Company and its shareholders when taking into account the Company's capital needs and the need for rapidly developing the Company's business to utilise its market position. Therefore, the Board of the Company has considered that there is a weighty financial reason for the Company to deviate from the pre-emptive subscription rights, and according to the Board of the Company, the Share Issue is in the interest of the Company and its shareholders. The subscription price was EUR 5.25 per Share. The subscription price represented a discount of approximately 13.8 per cent compared to the closing price of the Company's share on 26 June 2024. The subscription price has been determined through negotiations corresponding to a bookbuilding, involving a limited number of institutional and qualified investors. The investors were identified on the basis of their investment potential, expertise in the Company and its industry, and knowledge of the Finnish market. The purpose of the procedure has been to ensure the realisation of the financing arrangement and the subscription price being market based. The subscription price was credited in full to the Company's reserve for invested unrestricted equity. New shares subscribed for in Optomed Plc's directed share issue have been registered into the Finnish Trade Register, and the shares were admitted to trading on the official list of Nasdaq Helsinki Ltd on 1 July 2024. Risks and uncertainties Optomed has reviewed its complete risk position after the year end of 2024. The complete risk position is as follows. GEOPOLITICS Optomed operates globally. Geopolitical tensions may impact the competitiveness of Optomed's supply chain or sales, leading to increased costs or causing potential disruptions for example in the form of tariffs. HIGH QUALITY PRODUCTS The quality and safety of the Company's products are extremely important for Optomed's competitiveness. The Company may be adversely affected if it fails to continuously develop and update its fundus cameras and software solutions or to identify or integrate new products and product platforms into its offering. The Company's or its partners' products may also be subject to clinical trials, the results of which are critical for the products' regulatory approvals and market acceptance. STRATEGY AND M&A The Company may be unsuccessful in fulfilling its strategy or the strategy itself may be unsuccessful . The successful implementation of the Company's strategy depends upon a number of factors, some of which are completely or partially outside the Company's control. The Company has an appropriate risk management function in the context of the size of the Company's operations, however, it may not be able to identify or monitor all relevant risks and determine efficient risk management procedures and responsible persons that may again affect the strategy. The Company is also dependent on its ability to develop and manage varying routes-to-market for its products, the efficiency of its sales channels and its customer and distributor relationships. Further, the Company has an opportunistic view on M&A which by nature include inherent risks. Failure of strategy may force the Company to record write-downs on its goodwill. MARKET AND COMPETITION Optomed operates in a niche market that is highly competitive. Optomed operates in the fundus camera market that is developing fast and the competition is sometimes fierce. The market acceptance of the Company's products and solutions is important for our future growth. Optomed recognizes a possibility of new market changing products entering the market. Further, in certain key geographies the client base is limited and, therefore, a loss of a key customer in a key market may adversely affect our revenue streams. EXTERNAL ECONOMIC AND POLITICAL RISKS AND NATURAL DISASTERS Optomed operates globally and is thus exposed to various external risks. The Company is exposed to natural disasters taking place in countries where it operates and general and country specific economic political and regulatory risks, which could entail volatile sales in key markets. SUPPLY CHAIN Optomed's business is dependent on the effectiveness of purchasing materials, manufacturing and timely distribution. The Company is dependent on contract manufacturers for functioning, efficient and effective production and product assembly. Further, the Company is dependent on suppliers which may affect the Company's ability to supply its customers in a timely manner. SYSTEMS AND INFORMATION Our operations are increasingly dependent on IT systems. Disruption of the Company's IT systems could inhibit our business operations in a number of ways, including disruption to financial reporting, sales, production and cash flows. LITIGATION Optomed operates globally and pursues double-digit annual organic growth in medium term. Optomed may not always be able to reach the best contractual terms with stakeholders. The Company may be negatively affected by legal or administrative proceedings directed at the Company or third parties due to back-to-back liability, or other disputes and claims including product liability, especially in terms of medical devices, and intellectual property rights related items. TRADE SECRETS AND PATENTS The technologic capabilities are a competitive advantage that the Company must be able to protect. The Company may not be able to protect its trade secrets and know-how which could lead to losing the competitive advantage the Company has. At the same time, the Company maybe forced to take actions against parties that violate our IPRs. TALENT & ORGANISATION A skilled workforce and agile organisation are essential for the continued success of our business. The Company may be adversely affected if it would lose its key personnel or fails to attract the right talent. FINANCE The Company needs external financing to operate and is not currently profitable. The Company is dependent on external financing and the Company may have difficulties accessing additional financing on competitive terms or at all which may again contribute the Company's liquidity risks. The Company is also subject to credit and counterparty risks through its trade receivables. FOREX We operate globally and are thus exposed to currency exchange risks. The Company is exposed to foreign exchange rate risks arising from fluctuations in currency exchange rates, especially with regards USD, EUR and RMB. Currency rates, along with demand cycles, can result in significant swings in the prices of the raw materials needed to produce our goods and our sales prices and OPEX. LEGAL AND REGULATORY Compliance with laws and regulations is an essential part of Optomed's business operations. Optomed together with its suppliers and distributors operate globally and are subject to various national and regional regulations in the areas of medical devices, product safety, product claims, data protection, intellectual property rights, health and safety, competition, employment, taxes and anti-money laundering and anti- bribery & corruption (AML & ABC). Further, many of the Company's devices are subject to various medical related assessment (including clinical trials), clearance and approval processes that are required to place our products the market. Failure to comply these might lead to loss of sales permits in different markets, product recalls, reputational issues, civil and criminal actions leading to various direct and indirect damages to Optomed and its employees that are not completely covered by Optomed's insurance coverage. Especially, failures with respect to compliance with certain medical devices related regulations and processes may hinder the Company's devices' market access. The Board's proposal for the distribution of profit The parent company's non-restricted equity on 31 December 2024, was EUR 28,957,353.52 and the net loss for the financial year was EUR -4,931,484.87. The Board of Directors proposes to the Annual General Meeting that no dividend will be paid and the non-restricted equity on the outstanding 19,693,297 shares shall be retained and carried forward. Audit review This financial report has been audited by the company's auditors. Financial reporting in 2025 · 6 May 2025 Interim Report for 1 January - 31 March 2025 · 7 August 2025 Half-Year Financial Report for 1 January - 30 June 2025 · 6 November 2025 Interim Report for 1 January - 30 September 2025 For more information, contact Sakari Knuutti, CFO E-mail: sakari.knuutti@optomed.com Juho Himberg, CEO E-mail: juho.himberg@optomed.com About Optomed Optomed is a Finnish medical technology company and one of the leading providers of handheld fundus cameras. Optomed combines handheld fundus cameras with software and artificial intelligence with the aim to transform the diagnostic process of various eye diseases, such as rapidly increasing diabetic retinopathy. In its business Optomed focuses on eye screening devices and software solutions related R&D in Finland and sales through different channels in over 60 countries. www.optomed.com Alternative Performance Measures Optomed uses certain alternative performance measures (APMs) with the purpose to provide a better understanding of how the business develops. These APMs, as defined, cannot be fully compared with other companies' APMs. Alternative Definition Performance Measures Gross profit Revenue + Other operating income - Materials and services expenses Gross margin, % Gross profit / Revenue EBITDA Operating result before depreciation, amortization and impairment losses EBITDA margin, % EBITDA / Revenue Operating result Profit/loss after depreciation, amortization and impairment losses Operating margin, % Operating result / Revenue Adjusted operating Operating result excluding items affecting comparability result Adjusted operating Adjusted operating result / Revenue margin, % Adjusted EBITDA EBITDA excluding items affecting comparability Adjusted EBITDA Adjusted EBITDA / Revenue margin, % Items affecting Material items outside ordinary course of business comparability including restructuring costs, net gains or losses from sale of business operations or other non-current assets, strategic development projects, external advisory costs related to capital reorganisation, impairment charges on non-current assets incurred in connection with restructurings, compensation for damages and transaction costs related to business acquisitions. Net Debt Interest-bearing liabilities (borrowings from financial institutions, government loans and subordinated loans) - cash and cash equivalents (excl. lease liabilities according to IFRS 16) Net Debt / EBITDA Net Debt / EBITDA (for the last twelve months, LTM) (LTM), times Net Debt / Adjusted Net Debt / Adjusted EBITDA (for the last twelve months, EBITDA (LTM), times LTM) Earnings per share Net result / Weighted average number of outstanding shares Equity ratio, % Total equity / Total assets R&D expenses Employee benefit expenses for R&D personnel and other operational expenses related to R&D activities Reconciliation of Alternative Performance Measures In thousands of euro Q4/2024 Q4/2023 2024 2023 Revenue 5,099 3,660 15,040 15,100 Other operating income 0 21 10 49 Material and services -1,778 -1,192 -5,374 -4,857 Gross profit 3,321 2,489 9,676 10,292 Operating result (EBIT) -1,497 -1,319 -5,689 -3,974 Items affecting comparability Specific loss allowance 279 0 662 311 Adjusted EBIT -1,218 -1,319 -5,295 -3,663 Depreciation, 686 562 2,499 2,193 amortization and impairment losses Adjusted EBITDA -532 -757 -2,796 -1,470 Consolidated income statement In thousands of euro Q4/2024 Q4/2023 2024 2023 Revenue 5,099 3,660 15,040 15,100 Other operating income 0 21 10 49 Materials and services -1,778 -1,192 -5,374 -4,857 Employee benefit -2,631 -2,441 -8,931 -8,699 expenses Depreciation, -686 -562 -2,499 -2,193 amortization and Impairment losses Other operating expenses -1,502 -805 -4,204 -3,374 Operating result -1,497 -1,319 -5,957 -3,974 Finance income 758 56 1,217 479 Finance expenses -265 -286 -776 -1,024 Net finance expenses 493 -230 441 -545 Profit (loss) before -1,004 -1,550 -5,516 -4,519 income taxes Income tax expense 15 20 66 79 Loss for the period -989 -1,530 -5,450 -4,441 Loss for the period attributable to Owners of the parent -989 -1,530 -5,450 -4,441 company Weighted average number 18,675,167 16,706,508 18,675,167 16,706,508 of shares Basic loss per share -0.05 -0.09 -0.29 -0.27 (euro) Consolidated condensed comprehensive income statement In thousands of euro Q4/2024 Q4/2023 2024 2023 Loss for the period -989 -1,530 -5,450 -4,441 Other comprehensive income Foreign currency translation -406 172 -329 283 difference Other comprehensive income, net of -406 172 -329 283 tax Total comprehensive loss -1,395 -1,358 -5,778 -4,157 attributable to Owners of the parent company Consolidated balance sheet In thousands of euro December 31, 2024 December 31, 2023 ASSETS Non-current assets Goodwill 4,256 4,256 Development costs 8,288 7,731 Customer relationships 721 942 Technology 331 433 Other intangible assets 370 384 Total intangible assets 13,965 13,746 Tangible assets 652 710 Right-of-use assets 1,456 1,472 Deferred tax assets 12 23 Total non-current assets 16,085 15,951 Current assets Inventories 1,961 2,820 Trade and other receivables 3,268 3,190 Cash and cash equivalents 10,467 7,118 Total current assets 15,695 13,128 Total assets 31,781 29,079 In thousands of euro December 31, 2024 December 31, 2023 EQUITY Share capital 80 80 Share premium 504 504 Reserve for invested non-restricted equity 59,608 50,936 Translation differences 6 334 Retained earnings -31,111 -27,052 Profit (loss) for the financial year -5,450 -4,441 Total equity 23,637 20,361 LIABILITIES Non-current liabilities Borrowings from financial institutions 790 1,651 Government loans 521 713 Lease liabilities 1,017 991 Deferred tax liabilities 234 310 Total Non-current liabilities 2,561 3,665 Current liabilities Borrowings from financial institutions 794 794 Government loans 193 193 Lease liabilities 495 516 Trade and other payables 4,101 3,550 Total current liabilities 5,583 5,052 Total liabilities 8,144 8,718 Total equity and liabilities 31,781 29,079 Consolidated statement of changes in shareholders' equity Equity attributable to owners of the parent company +-------------+-------+-------+-----------+-----------+--------+-------+ |In thousands |Share |Share |Reserve |Translation|Retained|Total | |of euro |capital|premium|for |differences|earnings| | | | | |invested | | | | | | | |non | | | | | | | |-restricted| | | | | | | |equity | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ | | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Balance at |80 |504 |50,936 |334 |-31,493 | 20,361| |January 1, | | | | | | | |2024 | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Comprehensive| | | | | | | |income | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Loss for the | | | | |-5,450 |-5,450 | |period | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Other | | | | | | | |comprehensive| | | | | | | |income | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Translation | | | |-329 | |-329 | |differences | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Total | | | |-329 |-5,450 |-5,778 | |comprehensive| | | | | | | |income for | | | | | | | |the period | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Share issue | | | 7,322 | | |7,322 | +-------------+-------+-------+-----------+-----------+--------+-------+ |Share based | | | 43 | | |43 | |payments | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Share options| | |1307 | |382 |1,689 | +-------------+-------+-------+-----------+-----------+--------+-------+ |Total | | |8,672 | |382 |9,054 | |transactions | | | | | | | |with owners | | | | | | | |of the | | | | | | | |company | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ | | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Balance at |80 |504 |59,608 |6 |-36,560 | 23,637| |December 31, | | | | | | | |2024 | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ Equity attributable to owners of the parent company +-------------+-------+-------+-----------+-----------+--------+-------+ |In thousands |Share |Share |Reserve |Translation|Retained|Total | |of euro |capital|premium|for |differences|earnings| | | | | |invested | | | | | | | |non | | | | | | | |-restricted| | | | | | | |equity | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ | | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Balance at |80 |504 |46,896 |51 |-27,189 |20,342 | |January 1, | | | | | | | |2023 | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Comprehensive| | | | | | | |income | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Loss for the | | | | |-4,441 |-4,441 | |period | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Other | | | | | | | |comprehensive| | | | | | | |income | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Translation | | | |283 | |283 | |differences | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Total | | | |283 |-4,441 |-4,157 | |comprehensive| | | | | | | |income for | | | | | | | |the period | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Share issue | | |3,973 | | |3,973 | +-------------+-------+-------+-----------+-----------+--------+-------+ |Share based | | |48 | | |48 | |payments | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Share options| | |19 | |137 |156 | +-------------+-------+-------+-----------+-----------+--------+-------+ |Total | | |4,039 | |137 |4,176 | |transactions | | | | | | | |with owners | | | | | | | |of the | | | | | | | |company | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ | | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ |Balance at |80 |504 |50,936 |334 |-31,493 | 20,361| |December 31, | | | | | | | |2023 | | | | | | | +-------------+-------+-------+-----------+-----------+--------+-------+ Consolidated cash flow statement In thousands of euro Q4/2024 Q4/2023 2024 2023 Cash flows from operating activities Loss for the financial year -989 -1,530 -5,450 -4,441 Adjustments: Depreciation, amortization and 686 562 2,499 2,193 impairment losses Finance income and finance expenses -446 155 -466 468 Other adjustments 401 -22 653 289 Cash flows before change in net -349 -835 -2,764 -1,491 working capital Change in net working capital: Change in trade and other receivables -483 501 -335 1,094 (increase (-) / decrease (+)) Change in inventories 766 -48 901 118 (increase (-) / decrease (+)) Change in trade and other payables 407 -18 688 -75 (increase (+) / decrease (-)) Cash flows before finance items 341 -400 -1,510 -354 Interest paid -27 -42 -115 -169 Other finance expenses paid -59 -16 -121 -93 Interest received 63 0 151 0 Net cash from operating activities (A) 318 -457 -1,596 -615 Cash flows from investing activities Capitalization of development expenses -468 -527 -1,843 -2,199 Acquisition of tangible assets -145 -56 -275 -213 Net cash used in investing activities -613 -583 -2,118 -2,412 (B) Cash flows from financing activities Proceeds from share subscriptions 207 0 9,182 4,310 Share issue transaction costs 0 0 -553 -318 Repayment of loans and borrowings -323 -1,323 -1,053 -1,921 Repayment of lease liabilities -125 -92 -494 -462 Net cash from financing activities (C) -241 -1,415 7,081 1,609 Net cash from (used in) operating, -536 -2,456 3,367 -1,419 investing and financing activities (A+B+C) Cash and cash equivalents at beginning 10,963 9,565 7,118 8,524 of period Effect of movements in exchange rate 40 9 -19 13 on cash held Cash and cash equivalents at end of 10,467 7,118 10,467 7,118 period Selected notes Corporate information and basis of accounting Corporate information Optomed is a Finnish medical technology group (hereafter ‘Optomed' or ‘Group') that specialises in handheld fundus cameras and solutions for screening of blinding eye diseases, established in 2004. The Group's parent company, Optomed Plc (hereafter the ‘Company'), is a Finnish public limited liability company established under the laws of Finland, and its business ID is 1936446-1. It is domiciled in Oulu, Finland and the Company's registered address is Yrttipellontie 1, 90230 Oulu, Finland. Basis of accounting Optomed's consolidated financial statements has been prepared in accordance with International Financial Reporting Standards (IFRS) as adopted by the European Union. The preparation of this financial statements bulletin also takes into account the amendments to IFRS standards that have become effective by January 1, 2024. This financial report has been prepared in accordance with IAS 34 Interim Financial Reporting and it should be read in conjunction with Group`s annual consolidated financial statements All presented figures have been rounded so the sum of the individual figures may differ from the presented total figure. Financial ratios have been calculated using exact figures. This report has been authorized for issue by the company`s board of directors. Critical management judgments and related estimates and assumptions The preparation of financial statements under IFRS requires management to make judgments, estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities at the end of the reporting period as well as the reported amounts of income and expenses during the reporting period. These estimates and assumptions are based on historical experience and other justified assumptions, such as future expectations, that Optomed management believes are reasonable under the circumstances at the end of the reporting period and the time when they were made. Although these estimates are based on management's best knowledge of current events and actions, actual results may ultimately differ from those estimates. The estimates and underlying assumptions are reviewed on an on-going basis and when preparing financial statements. Changes in accounting estimates may be necessary if there are changes in the circumstances on which the estimate was based, or as a result of new information or more experience. Such changes are recognized in the period in which the estimate or the assumption is revised. Use of judgment and estimates Judgements that management has made in the process of applying accounting policies and that have the most significant effect on the amounts recognized in the financial statements, relate to the following areas: — Determining trade receivables credit risk — capitalization of development costs: determination of development expenditure eligible for capitalization — impairment testing of development expenditures Reportable segments Q4/2024 In thousands of euro Devices Software Group Total Admin External revenue 2,551 2,549 0 5,099 Net operating expenses -1,074 -704 0 -1,778 Margin 1,476 1,845 0 3,321 Depreciation and amortization -474 -210 -2 -686 Other expenses -1,592 -1,415 -1,126 -4,133 Operating result -589 219 -1,127 -1,497 Finance items 0 0 493 493 Loss before tax expense -589 219 -634 -1,004 Q4/2023 In thousands of euro Devices Software Group Admin Total External revenue 1,023 2,637 0 3,660 Net operating expenses -433 -738 0 -1,171 Margin 590 1,899 0 2,489 Depreciation and amortization -368 -192 -2 -562 Other expenses -1,160 -1,274 -811 -3,246 Operating result -938 432 -814 -1,319 Finance items 0 0 -230 -230 Loss before tax expense -938 432 -1,044 -1,550 2024 In thousands of euro Devices Software Group Total Admin External revenue 5,326 9,714 0 15,040 Net operating expenses -2,548 -2,825 9 -5,364 Margin 2,778 6,889 9 9,676 Depreciation and amortization -1,670 -819 -9 -2,499 Other expenses -4,451 -4,992 -3,692 -13,135 Operating result -3,343 1,078 -3,692 -5,957 Finance items 0 0 441 441 Loss before tax expense -3,343 1,078 -3,250 -5,516 2023 In thousands of euro Devices Software Group Admin Total External revenue 5,009 10,091 0 15,100 Net operating expenses -2,062 -2,745 0 -4,807 Margin 2,947 7,346 0 10,292 Depreciation and amortization -1,444 -740 -9 -2,193 Other expenses -4,210 -4,717 -3,146 -12,074 Operating result -2,707 1,889 -3,155 -3,974 Finance items 0 0 -545 -545 Loss before tax expense -2,707 1,889 -3,701 -4,519 Revenue In thousands of euro Q4/2024 Q4/2023 2024 2023 Finland 2,446 2,463 9,340 62% 9,643 64% Rest of the Europe 188 421 1,034 7% 1,870 12% Rest of the World 2,466 776 4,667 31% 3,586 24% Total 5,099 3,660 15,040 100 % 15,100 100% Other operating expenses In thousands of euro Q4/2024 Q4/2023 2024 2023 Sales and marketing -247 -185 -707 -635 Research and development -105 -43 -297 -230 General and administration -1,151 -576 -3,200 -2,509 Total operating expenses -1,502 -805 -4,204 -3,374 Other operating expenses also comprise changes in expected credit losses and realized credit losses. Tangible assets In thousands of euro Machinery and equipment Machinery and equipment 2024 2023 Cost Balance at January 1 3,724 3,512 Additions 286 212 Balance at End of 4,010 3,724 Period Accumulated depreciation and impairment losses Balance at January 1 -3,015 -2,660 Depreciation -342 -355 Balance at end of -3,357 -3,015 period Carrying amount at 710 852 January 1 Carrying amount at 652 710 December 31 Leases Leased tangible assets In thousands of euro 2024 2023 Additions to right-of-use assets 498 532 Depreciation charge for right-of-use assets -514 -508 Carrying amount at the end of the reporting period 1,456 1,472 Leased tangible assets comprise business premises and cars. Lease liabilities In thousands of euro 2024 2023 Current 495 516 Non-current 1,017 991 Total 1,512 1,507 The above liabilities are presented on the line item Lease liabilities (non -current / current) in the consolidated balance sheet, based on their maturity. Intangible assets and goodwill At December 31, 2024 In thousands Goodwill Development Customer Technology Other Total of euro costs relationships intangible assets Cost Balance at 4,256 16,067 2,222 1,023 1,147 24,715 January 1 Additions 0 1,797 0 0 58 1,855 Balance at 4,256 17,864 2,222 1,023 1,205 26,570 December 31 Accumulated - amortisation and impairment losses Balance at 0 -8,336 -1,280 -590 -763 -10,969 January 1 Amortization 0 -1,049 -221 -102 -72 -1,445 Impairment 0 -191 0 0 0 -191 losses Balance at 0 -9,576 -1,501 -692 -835 -12,605 December 31 - Carrying 4,256 7,731 942 433 384 13,746 amount at January 1 Carrying 4,256 8,288 721 331 370 13,965 amount at December 31 At December 31 2023 In thousands Goodwill Development Customer Technology Other Total of euro costs relationships intangible assets Cost Balance at 4,256 13,978 2,222 1,023 1,054 22,533 January 1 Additions 0 2,089 0 0 93 2,182 Balance at 4,256 16,067 2,222 1,023 1,147 24,715 December 31 Accumulated - amortisation and impairment losses Balance at 0 -7,416 -1,057 -489 -676 -9,638 January 1 Amortization 0 -920 -223 -101 -66 -1,311 Impairment 0 0 0 0 -21 -21 losses Balance at 0 -8,336 -1,280 -590 -763 -10,969 December 31 - Carrying 4,256 6,562 1,164 534 379 12,895 amount at January 1 Carrying 4,256 7,731 942 433 384 13,746 amount at December 31 Financial assets Current financial assets In thousands of euro 2024 2023 Trade receivables Other trade receivables 2,411 2,583 Total trade receivables 2,411 2,583 Cash and cash equivalents 10,467 7,118 Total 12,878 9,701 Due to overdue trade receivables, financial assets are subject to an increased risk of credit loss. Exposure to credit risk and loss allowance Chinese customer's trade receivables EUR 1,099 thousand have been written down at the end of Q4 2024. Specific loss allowance is at 100%. In thousands Gross carrying amount Weighted av. Loss of euro loss rate% allowance At December 31, 2024 Current (not 2,314 0.50% 12 past due) Past due 1-30 days 67 1.50% 1 31-60 days 31 4% 1 61-90 days 9 9% 1 More than 90 6 12% 1 days past due Specific loss 0 100% 0 allowance Total 2,427 15 In thousands Gross carrying amount Weighted Loss of euro av. allowance loss rate% At December 31, 2023 Current (not 1,516 0.50% 8 past due) Past due 1-30 days 51 1.50% 1 31-60 days 4% 0 6 61-90 days 10 9% 1 More than 90 277 12% 33 days past due Specific loss 1,534 50% 767 allowance Total 3,392 809 Financial liabilities In thousands of euro December 31, 2024 December 31, 2023 Non-current financial liabilities Borrowings from financial institutions 790 1,651 Government loans 521 713 Lease liabilities 1017 991 Total 2,328 3,355 In thousands of euro December 31, 2024 December 31, 2023 Current financial liabilities Borrowings from financial institutions 794 794 Government loans 193 193 Lease liabilities 495 516 Trade payables 891 782 Total 2,373 2,285 Total financial liabilities 4,700 5,640 Fair values - financial liabilities measured at amortized cost. Optomed considers that the carrying amounts of the financial liabilities measured at amortized cost substantially equal to their fair values. Financial covenants Optomed's borrowings from financial institutions contain a financial covenant (equity ratio). Optomed has to comply with the financial covenant terms specified in the loan agreement terms at the financial year-end. Equity ratio is calculated using the agreed formula. The table below summarizes the Group's financial covenant term and compliance during the reporting period. Covenant term Actual ratio Applicable level OP loan equity ratio At December 31, 2024 35% 87.1% Optomed Group At December 31, 2023 35% 83.1% Optomed Group Company's Equity ratio is calculated as follows. OP loan equity ratio calculation formula: Adjusted equity/(Balance sheet total- received advances-goodwill) Optomed was in compliance with the covenant as at December 31. 2024. Related party transactions In thousands of euro Revenues Trade receivables Other expenses Jan 1 - Dec 31 2024 0 0 -92 Jan 1 - Dec 31 2023 0 0 -78 Revenue and trade receivables and some of the other expenses relate to the major shareholders of Optomed Ltd considered to be related parties to the parent company. Other expenses consist of consulting fees paid to the Chairman of the Board of Directors and members of the Board. Events after the review period No material events after the review period. |
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