Optomed Plc: Interim Report, January – September 2024

Optomed Plc Stock Exchange Release 7 November 2024 at 9.00, Helsinki

Optomed Plc: Interim Report, January – September 2024

July – September 2024

• Revenue decreased by 26.3 percent to EUR 3.1 (4.2) million against a strong comparison period of Q3-2023 that was supported by a Device segment delivery to Spain worth approximately EUR 0.8 million and a large delivery to China
• Devices segment revenue decreased by 55.5 percent to EUR 0.8 (1.8) million. Without the Q3 2023  one-time deal in Spain, the revenue would have decreased EUR 0.2 million.
• Software segment revenue decreased by 4.0 percent to EUR 2.3 (2.4) million.
• EBITDA was EUR -0.8 (-0.0) million corresponding to -26.2 (-1.1) percent of revenue.
• Optomed received a payment of EUR 0.5 million from the Chinese customer to which the Company has a credit loss provision of 75%. This positively affected the EBITDA EUR 0.3 million. The total amount of the receivable in the balance sheet is now EUR 0.3 million.
• EBITDA was negatively affected by an inventory revaluation of EUR 0.3 million and positively affected by EUR 0.4 million reversal of credit loss provision related to China.
• Optomed decreased its outlook on 25 September 2024. According to the new outlook, Optomed expects its full year 2024 revenue to decrease from 2023. Previously, Optomed expected its revenue to grow in 2024.

January – September 2024

• Revenue decreased by 13.1 percent to EUR 10.0 (11.4) million.
• Devices segment revenue decreased by 30.4 percent to EUR 2.8 (4.0) million. The comparison period included one-time deal of EUR 0.8 million in Spain. Without the deal, the revenue would have decreased EUR 0.4 million.
• Software segment revenue decreased by 3.9 percent to EUR 7.2 (7.5) million.
• Adjusted EBITDA amounted to EUR -2,3 (-0,7) million corresponding to -22.8 (-6.2) percent of revenue and EBITDA amounted to -2.6 (-1.6) EUR million.
• Optomed Aurora with AEYE-DS AI successfully received FDA clearance in Q2-2024.
• Optomed signed a shareholder's agreement with Zhongbao Fund to establish a joint venture in China in Q2-2024.
• Optomed successfully completed directed share issue in Q2-2024 raising gross proceeds approximately EUR 7.9 million.

Key figures

*) 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.

CEO Review

Our third-quarter results have highlighted both achievements and areas for improvement. Our performance did not meet expectations, particularly within the traditional capex sales of the Device segment, where we faced a tough comparison of Q3 2023, when we received a substantial one-time order of EUR 800 thousand from Spain and a large order from China. During the third quarter of 2024, the Devices segment didn’t receive any individual large orders, and this dynamic can be seen as large revenue fluctuations between our quarters.

The Software segment showed relative stability, with a significant win in the dental imaging sector—a promising new business area for us—representing annual recurring revenue of several hundreds of thousands, although its implementation has been delayed to FY2025. Furthermore, we signed the final agreements for the substantial multi-year tender in the Finnish non-healthcare segment, initially communicated in Q2 and formally signed in Q3.

Following last year’s large-scale delivery to Spain’s screening initiative, Optomed has continued to pursue similar opportunities, with additional projects and tenders aiming to expand large-scale screening efforts in Italy and several Asian countries.

Regarding our joint venture in China, we have localized the software required for screening and prepared for a pilot project to achieve technical readiness. Additionally, we have completed the administrative work towards formally establishing the joint venture. The joint venture business in China will not generate revenue in 2024.

Our cash position remains strong at EUR 11 million and net debt at EUR -8,3 million.

Oculomics and Aurora AEYE

One of the fastest-growing fields in healthcare today is oculomics. This emerging area leverages eye imaging to detect and monitor systemic conditions such as diabetes, cardiovascular diseases, and neurological disorders. Industry experts anticipate that handheld cameras will capture 70-80% of oculomic images due to their accessibility and portability, positioning them as critical tools in this rapidly evolving market.

A significant amount of investment is flowing into oculomics, as rapid advancements in computing power and algorithm development drive innovation. Optomed is uniquely positioned to capitalize on these developments, having established itself as the only handheld camera company with FDA clearance for autonomous AI diagnostics—a significant achievement that underlines our commitment to advancing healthcare technology. Moreover, our next-generation handheld camera, designed specifically to accelerate oculomics applications, has recently obtained CE marking. We plan to launch this device in select markets at a time of our choosing.

Aurora AEYE Commercialization

Aurora AEYE’s commercialization is progressing well, with promising market traction. The product has received encouraging feedback from end-users, sparking interest not only from in-clinic providers but also from home healthcare providers and mobile screening services. After the initial trial period, during which we executed, among others, software updates to both the camera and the portal, new accounts have been closed on a weekly basis. Furthermore, Aurora AEYE is currently being piloted in some of the largest U.S. hospital systems, where it is demonstrating the advantages of portable AI solutions over traditional tele-retinal programs. To further support expansion, Optomed is working closely with AEYE Health to onboard distributors and resellers, with numerous large reseller groups expressing interest in the product.

As we move forward, Optomed’s focus on innovation within oculomics and commitment to strategic partnerships will continue to position us as a leader in transforming accessible healthcare diagnostics worldwide.

Juho Himberg

CEO

Outlook 2024

Optomed expects its full year 2024 revenue to decrease compared to 2023.

Telephone conference

A telephone conference for analysts, investors and media will be arranged on 7 November 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 705 416 745#

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

July – September 2024

In July - September 2024, Group revenue decreased by 26.3 percent to EUR 3,109 (4,218) thousand. The Devices-segment revenue decreased 55.5 percent to EUR 813 (1,825) thousand against a strong comparison period of Q3-2023 that was supported a delivery to Spain worth approximately EUR 0.8 million. The Software segment revenue decreased by 4.0 percent to EUR 2,297 (2,393) thousand.

In July-September 2024, the gross margin decreased to 54.4 percent from 67.4 percent of last year. The decrease was driven by the inventory revaluation of EUR 0.3 million

EBITDA decreased and it was EUR -814 (-48) thousand. As gross margin, EBITDA was negatively affected by an inventory revaluation of EUR 0.3 million and, additionally, positively affected by EUR 0.4 reversal of credit loss provision related to China.

EBIT decreased and it was EUR -1,400 (-603) thousand.

In July - September 2024, net financial items amounted to EUR -198 (144) thousand and consisted mainly of interest income and the translation effect of CNY and USD to EUR.

January – September 2024

In January – September 2024, Group revenue decreased by 13.1 percent to EUR 9,941 (11,440) thousand. Devices segment’s revenue decreased by 30.4 percent while the Software segment’s revenue decreased by 3.9 percent.

The gross margin decreased to 63.9 percent from 68.2 percent last year.

EBITDA amounted to EUR -2,647 (-1,024) thousand and EBIT was EUR -4,460 (-2,655) thousand.  

Net financial items amounted to EUR -52 (-315) thousand and consisted mainly of interest income and the translation effect of Chinese RMB to EUR.

In Q2-2024, Optomed Aurora with AEYE-DS AI successfully received FDA clearance.

In Q2-2024 Optomed signed a shareholder’s agreement with regards to a joint venture in China with Zhongbao, a Chinese private equity firm based in Shenzhen, China. The firm focuses on growth opportunities, and it invests in a diversified range of industries. Optomed will own 19.9% of the joint venture and Zhongbao 80.1%. The business model for this venture will be a recurring revenue model, ensuring sustainability and long-term success.

Cash flow and financial position

July – September 2024

In July - September 2024, the cash flow from operating activities amounted to EUR -1,434 (767) thousand. Net cash used in investing activities was EUR -412 (-615) thousand and relates to capitalized development expenses. Net cash from financing activities amounted to EUR 681 (3,721) thousand. The net cash from financing activities was positively affected by option subscriptions.

Consolidated cash and cash equivalents at the end of the period amounted to EUR 10,963 (9,565) thousand. Net debt was EUR -8,343 (-4,890) thousand at the end of the period.

Net working capital was EUR 2,093 (2,802) thousand at the end of the period.

Optomed has large trade receivables from a Chinese customer. The customer has missed several payments since H2-2023 and, consequently, the specific loss allowance weighted average loss rate was increased to 75% in Q2-2024. In Q3, Optomed received EUR 455 thousand payment from the customer which reduced credit loss provision by EUR 340 thousand. However, the credit loss provision of 75 % remains as-is. The total amount of the receivable in the balance sheet is now EUR 269 thousand.

January – September 2024

In January- September 2024, the cash flow from operating activities amounted to EUR -2,006 (-120) thousand.

Net cash used in investing activities was EUR -1,482 (-1,828) thousand and relates to capitalized development expenses.

Net cash from financing activities amounted to EUR 7,298 (3,024) thousand.

Optomed completed a directed share issue consisting of 1,500,000 shares and collected gross proceeds of approximately EUR 7.9 million in June 26 2024.

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).

*) Alternative performance measures, see section Alternative Performance Measures for definitions and calculations.

July – September 2024

In July - September 2024, the Devices segment revenue decreased by 55.5 percent to EUR 813 (1,825) thousand as no large deliveries were made during the quarter. The revenue remained stable in the US and in the OEM channel. Revenue declined in China and the distributor revenue decreased against a strong comparison period of Q3-2023 that was supported by a Device segment delivery to Spain worth approximately EUR 0.8 million and a large delivery to China

The gross margin was 11.1 (61.6) percent. The decrease was driven by the inventory revaluation of EUR 0.3 million.

EBITDA was EUR -510 (-50) thousand or -62.8 (-2.7) percent of revenue. EBITDA was negatively affected by an inventory revaluation of EUR 0.3 million and positively affected by EUR 0.4 reversal of credit loss provision related to China.

January – September 2024

In January - September 2024, the Devices segment revenue decreased by 30.4 percent to EUR 2,776 (3,986) thousand. The decrease was driven by weaker than expected sales of the global distributor sales and OEM channels.

The gross margin decreased to 46.9 percent from 59.1 percent. The decrease was driven by the inventory revaluation of EUR 0.3 million.

EBITDA was EUR -1,558 (-693) thousand or -56.1 (-17.4) 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.

*) Alternative performance measures, see section Alternative Performance Measures for definitions and calculations.
 

July – September 2024

In July - September 2024, the Software segment decreased by 4.0 percent to EUR 2,297 (2,393) thousand.

The gross margin decreased and was 69.7 (71.8) percent.

EBITDA was EUR 486 (636) thousand or 21.2 (26.6) percent of revenue.

During the quarter, the Software segment won a dental imaging related public procurement process in Finland. However, the final agreements are yet to be signed and the revenue from the project and later from the service is expected to start only in 2025. The annual recurring revenue is expected to be in the range of several hundreds of thousands.

January – September 2024

In January - September 2024, the Software segment revenue decreased by 3.9 percent to EUR 7,165 (7,454) thousand.

Gross margin decreased and it was 70.4 (73.1) percent. EBITDA was EUR 1,468 (2,004) thousand or 20.5 (26.9) 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.

July – September 2024

Group-wide operating expenses amounted to EUR 789 (635) thousand.

January – September 2024

Group-wide operating expenses amounted to EUR 2,566 (2,335) thousand.

Personnel

Number of personnel at the end of the reporting period.

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 Q1-Q3 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 19,630,397 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.

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

The key risks and uncertainties are described in the company’s Annual Report 2023 which was published on 29 February 2024. The complete report is available at https://www.optomed.com/investors/. The risk position of Optomed has not changed since then, except for that the risks titled "AURORA AEYE FDA CLEARANCE PROCESS" and “PUBLIC PROCUREMENT” are no longer applicable.  

Audit review

This financial report has not been audited by the company's auditors.

Financial reporting in 2025

• 13 February 2025   Financial Statement Bulletin for 1 January – 31 December 2024
• 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.

Reconciliation of Alternative Performance Measures

Consolidated income statement

Consolidated condensed comprehensive income statement

Consolidated balance sheet

Consolidated statement of changes in shareholders’ equity

Equity attributable to owners of the parent company

Equity attributable to owners of the parent company

Equity attributable to owners of the parent company

Consolidated cash flow statement

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 Interim Report also takes into account the amendments to IFRS standards that have become effective by January 1, 2024.

This Interim financial statement is prepared in accordance with IAS 34 Interim Financial Reporting and should be read in conjunction with Group`s last annual consolidated financial statements as at and for the year ended 31 December 2023. These Interim financial statements do not include all of the information required by IAS 34: selected explanatory notes are included to explain events and transactions that are significant to an understanding of the changes in the Group`s financial position and performance since the last annual 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.

Reportable segments

Q3/2024

Q3/2023

Q1-Q3/2024

Q1-Q3/2023

2023

Other operating expenses

Other operating expenses also comprise changes in expected credit losses and realized credit losses.

Exposure to credit risk and loss allowance

Optomed considers it has heightened risk regarding Chinese customer's trade receivables. The credit risk concentration has been formed and is associated with an increased credit loss risk due to overdue trade receivables. Specific loss allowance weighted average loss rate% increased from comparison period 50% to 75%. During the quarter, Optomed received EUR 455 thousand payment from the customer.

Financial liabilities

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.

Events after the review period

No material events after the reporting period.