Optomed Plc: Half-year financial report, January – June 2022

Optomed Plc Stock Exchange Release 4 August 2022 at 9.00, Helsinki

 Optomed Plc: Half-year financial report, January – June 2022

April – June 2022

• Revenue decreased by 7.0 percent to EUR 3,7 (4,0) million.
• Devices segment revenue decreased by 28.2 percent to EUR 1,4 (1,9) million as the revenue from China declined over 90% whereas the rest of the world grew over 40%.
• Software segment revenue increased by 12.1 percent to EUR 2,4 (2,1) million.
• Adjusted EBITDA amounted to EUR -813 (177) thousand corresponding to -21.8 (4.4) percent of revenue.
• Optomed successfully completed directed share issue raising EUR 4.8 million.

January – June 2022

• Revenue decreased by 12.7 percent to EUR 6,9 (8,0) million.
• Devices segment revenue decreased by 27.5 percent to EUR 2,4 (3,3) million.
• Software segment revenue decreased by 2.0 percent to EUR 4,5 (4,6) million.
• Adjusted EBITDA amounted to EUR -1,750 (-138) thousand corresponding to -25.2 (-1.7) percent of revenue.
• Optomed announced the results from the prospective, multi-center clinical trial intended to assess its handheld fundus camera Aurora together with AEYE Health’s AI for autonomous detection of more than mild diabetic retinopathy, and the FDA clearance process is proceeding as planned.

Key figures

CEO Review

Significant growth investments and recruitments in the United States.

The first half of the year was weak, as exptected. The second half and the near future looks strong.

Optomed completed in May a direct share issue raising gross proceeds of EUR 4.8 million.

The second quarter and therefore also the first half of the year were weak, as previously predicted, caused by decrease in revenue from China. The near future looks strong due to rapid growth from Western markets and the upcoming new product launches, such as the Aurora AEYE, are expected to accelerate growth in the coming years.  We expect sales in China to pick up during the second half of the year, however the Chinese market has been a significant part of Optomed’s revenue in the past years, and there are still major uncertainties regarding the market recovery in China. We maintain our current full year outlook, but despite our success in Western markets, the Chinese market still causes uncertainty over the full year revenue.

The US market will be centric for the success of Optomed’s strategic goals and revenue growth for the next five years. Diabetic retinopathy screenings are expected to move to primary care with accelerating pace as the new national AI-based reimbursement code for diabetic retinopathy screening (CPT 92229) was approved by the US authorities (Centers for Medicare and Medicaid, CMS) early 2022. Because of the high reimbursemet enabled by the new code as well as Medicare star rating benefits, diabetic retinopathy screenings are highly profitable for primary care units. According to various estimates, there are currently approximately 200,000 – 500,000 different point of care units in the United States that may start screening for diabetic retinopathy in the coming years, and are potential customers of Optomed’s Aurora AEYE solution.

According to the estimate we made together with our partners, customers and advisors, in the next 5-10 years there will be at least 50,000 – 100,000 fundus cameras connected to artificial intelligence in the United States to screen for diabetic retinopathy and later also for other blinding- and systemic diseases. It is expected that a few market leaders will supply the majority of these devices. Optomed aims to be one of these market leaders with its highly competitive products and early market entry. If we succeed in this, the diabetic retinopathy screening market in the United States alone will be able to multiply Optomed’s revenue, and it will all be reoccurring revenue.

We are currently focusing our growth investments strongly in the United States. The FDA clearance process for our Aurora AEYE product is proceeding as planned. During the past quarter, we have hired additional sales and marketing personnel in the United States, and started training and preparing our organization and partners for the upcoming product launch. Optomed currently has a strong management, sales- and marketing and other operational organization ready in the USA.

In the rest of the world, the company's operating expenses are decreasing. Our largest long-term development projects are getting closer to completion and as a result, the company's fixed costs and investments will decrease outside the US during the second half of the year. As a result, and despite increasing investments in the US market, the company's profitability is expected to improve in the near future.

Seppo Kopsala

CEO

Outlook 2022

Optomed expects its full year 2022 revenue to grow compared to 2021.

Telephone conference

A telephone conference for analysts, investors and media will be arranged on 4 August 2022 at 11.00 EEST, (10.00 CEST). The event will be held in English. The presentation material will be available at www.optomed.com/investors 10.00 EEST 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 is 552 064 878#.

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

April – June 2022

In April-June 2022, Group revenue decreased by 7.0 percent to EUR 3,733 (4,012) thousand. The main reason for the decline was the earlier communicated changes in China impacting camera sales. This was partly compensated by strong sales of the Software segment, and the strong global distributor and OEM sales of the Devices segment”. The Devices segment’s revenue decreased by 28.2 percent  as the revenue from China declined over 90% whereas the rest of the world grew over 40% and the Software segment’s revenue increased by 12.1 percent compared to same period last year.

The gross margin decreased to 57.6 from 82.9 percent of last year. The Company received grants and other operating income EUR 0 (624) thousand. The gross margin of the comparison period in 2021 was boosted by Business Finland waiving a loan of the Company in the amount of EUR 538 thousand. The gross margin for the second quarter of 2022 adjusted for grants and other operating income would have been 57.6 percent compared to 67.3 percent in 2021.

EBITDA amounted to EUR -813 (177) thousand. The lower gross profit in the second quarter 2022 compared to 2021 was mainly caused by lower revenue in China and higher gross profit in 2021. EBIT was EUR -1,355 (-859) thousand.

Net financial items amounted to EUR 6 (-25) thousand and consisted mainly of interest payments to financial institutions and the translation effect of Chinese RMB and USD to EUR.

January – June 2022

In January-June 2022, Group revenue decreased by 12.7 percent to EUR 6,947 (7,956) thousand, driven mainly by the same reasons as for the second quarter. The Devices segment’s revenue decreased by 27.5 percent and the Software segment’s revenue decreased by 2.0 percent.

The gross margin decreased to 62.4 percent from 74.2 percent last year. The Company’s other operating income includes governmental grants of EUR 37 (705) thousand in the first half of 2022 and 2021, which increased the gross margin of both periods. The gross margin for the first half of 2022 adjusted for the total amount of the grants and other operating income would have been 61.9 percent compared to 65.3 percent in 2021.  

EBITDA amounted to EUR -1,750 (-138) thousand and EBIT was EUR -2,815 (-1,710) thousand.

Net financial items amounted to EUR 77 (191) thousand and consisted mainly of interest payments to financial institutions and the translation effect of Chinese RMB to EUR.

Cash flow and financial position

In April-June 2022, the cash flow from operating activities amounted to EUR -965 (-1,403) thousand. Net cash used in investing activities was EUR -825 (-489) thousand and relates to capitalized development expenses. Net cash from financing activities amounted to EUR 4,208 (-6). Optomed completed in May a direct share issue raising gross proceeds of EUR 4.8 million.

Consolidated cash and cash equivalents at the end of the period amounted to EUR 7,079 (7,818) thousand. Interest-bearing net debt totalled EUR -825 (-2,042) thousand at the end of the period.

Net working capital was EUR 4,239 (4,804) thousand at the end of the period.

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.

April-June 2022

In April-June 2022, the Devices segment revenue decreased by 28.2 percent to EUR 1,361 (1,896) thousand. The negative growth was mainly due to changes in China, which were communicated in February, impacting camera sales. This was partly compensated by strong global distributor and OEM sales. The revenue from China declined over 90% whereas the rest of the world grew over 40%.

The gross margin decreased to 47.2 percent from 95.5 percent in the previous year and the other operating income was EUR 0 (623) thousand. The delta was due to the previously mentioned waived loan. In the second quarter of 2022 the gross margin adjusted for grants and the total amount of other operating income would have been 47.2 percent compared to 62.6 percent in 2021. The increased share of OEM sales of the total sales also affected the gross margin negatively.

EBITDA was EUR -464  (593) thousand or -34.1 (31.3) percent of revenue. The key driver for the decrease in EBITDA was the lower revenue in China and gross margin.

January-June 2022

In January-June 2022, the Devices segment revenue decreased by 27.5 percent to EUR 2,425 (3,343) thousand, mainly driven by the same reasons as for the second quarter.

The gross margin decreased to 52.9 percent from 79.4  percent in the previous year. In 2022, the first half year gross margin adjusted for other operating income would have been 51.4 percent compared to 58.3 percent in 2021.

EBITDA was EUR -963 (362) thousand or -39.7 (10.8) percent of revenue. The reason for the decrease in EBITDA was mainly the same as for the second quarter.

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.

April – June 2022

In April-June 2022, The Software segment revenue increased by 12.1 percent to EUR 2,372 (2,116) thousand. A large license delivery that was postponed from Q1 was delivered in Q2 which had a positive effect on Q2, whereas Q1 was previously negatively impacted. Global screening solution projects continued well in Asia and the Middle-East. EBITDA stood at EUR 478 (248) thousand or 20.2 (11.7) percent of revenue, respectively.

January – June 2022

In January-June 2022, the Software segment revenue decreased by 2.0 percent to EUR 4,522 (4,613) thousand, EBITDA was EUR 898 (788) thousand or 19.9 (17.1) percent of revenue.

Group-wide expenses

Group-wide expenses relate to functions supporting the entire group such as treasury, group accounting, legal, HR, and IT.

April – June 2022

Group-wide operating expenses amounted to EUR 827 (664) thousand.  The increase is mainly related to strengthened of Group Marketing function, started already in second half of 2021. 

January – June 2022

Group-wide operating expenses amounted to EUR 1,685 (1,288) thousand. The change is due to strengthening of Group Marketing function.

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 2021 is available on the company website www.optomed.com/investors/.

Annual General Meeting

On 10 May 2022, Optomed held its Annual General Meeting (AGM) that adopted the financial statements for the financial period ended on 31 December 2021 and the remuneration report for governing bodies and discharged the members of the Board of Directors and the CEO from liability for the financial period ended on 31 December 2021. The AGM resolved that no dividend will be paid for the year 2021.

The number of members of the Board of Directors was confirmed as five. Xisi Guo, 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 remuneration will be paid once a year in August, after Optomed’s H1 report has been announced.

The AGM decided to 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 Tapio Raappana will continue as the auditor with principal responsibility.

The Annual General Meeting resolved in accordance with the Board’s proposal to amend Section II.2.3 of Stock Option Plan 2017B to extend the subscription period for shares by two (2) years, so that the subscription period pursuant to all option rights granted under Stock Option Plan 2017B will end on 1 July 2024.

The 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 1,400,314 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 General Meeting authorized the Board of Directors to decide on the issuance of shares as well as the issuance of option rights 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 1,400,314. 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 the 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)

       Seppo Mäkinen

       Anna Tenstam

Remuneration Committee:

       Seppo Mäkinen (Chairman)

       Reijo Tauriainen

       Anna Tenstam

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 15,400,997 shares and the company held 386 517  shares in the treasury which approximately corresponds to 2.5 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/.

Directed share issue

Optomed completed a directed share issue costisting of 1,397,853 shares and collected gross proceeds of approximately EUR 4.8 million in May 2022. The main purpose of the share issue was to ensure sufficient financing for the implementation of the Company’s growth strategy especially in the US diabetic retinopathy screening market and to strengthen its balance sheet. The subscription price was EUR 3.45 per share corresponding to a discount of approximately 6.76 per cent to the closing price of the Company’s share on 5 May 2022. The subscription price was credited in full to the Company’s reserve for invested unrestricted equity. The investors include institutional and qualified investors with past experience and expertise in the medical devices sector (such as Joensuun Kauppa & Kone Oy, Timo Syrjälä, Markku Kaloniemi, Berenberg funds and SP funds), which the Company expects to support the Company’s strategy and demonstrate the Company’s attractive position in the market. The new shares were registered in the Finnish Trade Register and trading in the new shares together with the existing shares commenced on Nasdaq Helsinki Ltd on 10 May 2022.

Risks and uncertainties

The key risks and uncertainties are described in the company’s annual report 2021 which was published on 4 March 2022. The complete report is available at https://www.optomed.com/investors/. The risk position of Optomed has not changed since then.

Audit review

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

Financial reporting in 2022

3 November 2022 Interim Report for 1 January – 30 September 2022

For more information, contact

Lars Lindqvist, CFO

Tel: +46 702 59 57 89

E-mail: lars.lindqvist@optomed.com

Seppo Kopsala, CEO

Tel.: +358 40 555 1050

E-mail:  seppo.kopsala@optomed.com

About Optomed

Optomed is a Finnish medical technology company and one of the leading providers of handheld fundus cameras. Optomed combines handheld screening devices with software and artificial intelligence with the aim to transform the diagnostic process of blinding 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.

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.

Consolidated income statement

Consolidated condensed comprehensive income statement

Consolidated balance sheet

Consolidated statement of changes in shareholders’ equity

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, 2022.

All presented figures have been rounded. Financial ratios have been calculated using exact figures.

These interim financial statements have been 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 2021.

This Interim financial statements do not include all of the information required for a complete set of IFRS financial statements: 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.

This report has been authorised 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 recognised in the financial statements, relate to the following areas:

— Determining trade receivables credit risk

— capitalisation of development costs: determination of development expenditure eligible for capitalisation

— impairment testing of development expenditures

Reportable segments

Q2/2022

Q2/2021

H1/2022

H1/2021

2021

Revenue

Disaggregation of revenue

Other operating income

Other operating income consist of received grants, profit from sales of fixed assets and Business Finland loan conversion to grant during the 2021 comparison period. During the financial years 2021-2022 Optomed has received government grants from various organisations, such as Business Finland.

Other operating expenses

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

Tangible assets

Leases

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

Financial assets

Carrying amounts - at amortised cost

Due to overdue trade receivables, financial assets are subject to an increased risk of credit loss.

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. Chinese customer has paid its overdue receivable according to planned schedule.Planned schedule was renegotiated in July.

Financial liabilities

In the financial year 2022 the Group extended the repayment schedule for borrowings from OP bank and in 2021 negotiated new loan from Nordea.

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. This estimate corresponds to the fair value hierarchy Level 3, as the measurement of the said liabilities is based on Optomed management view.

Financial covenant

Optomed's borrowings from financial institutions contain a financial covenant (equity ratio) and Optomed also has to meet certain key operative targets. The borrowings will be repaid in accordance with the new repayment schedule.

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.

Company’s Equity ratio is calculated as follows depending on the lender:

Nordea loan equity ratio calculation formula:  Adjusted equity/(Balance sheet total+ Leasing liabilities)

OP loan equity ratio calculation formula:  Adjusted equity/(Balance sheet total- received advances)

Optomed was in compliance with the covenant as at June 30, 2022.

Related party transactions

Revenues and trade receivables relate to the major shareholders of Optomed Plc considered to be related parties to the parent company.

Other expenses consist of consulting fees and travel expenses paid to the Chairman of the Board of Directors.

Events after the review period

Chinese customer’s payment schedule was renegotiated in July. Management view is, that risk for credit loss has not increased.