Optomed Plc         Stock Exchange Release    17 February 2023 at 9:00, Helsinki

Optomed Plc: Financial statements bulletin, January-December 2022

• Revenue increased by 13.0 percent to EUR 4.0 (3.6) million.
• Devices segment revenue decreased by 4.0 percent to EUR 1.3 (1.3) million.
• Software segment revenue increased by 23.2 percent to EUR 2.7 (2.2) million driven by strong healthcare solution sales.
• EBITDA amounted to EUR -0.3 (-1.5) million corresponding to -8.7 (-43.0) percent of revenue.
• Optomed successfully completed directed share issue raising EUR 4.1 million.
• Optomed expects its full year 2023 revenue to grow compared to 2022.

• Revenue decreased by 1.3 percent to EUR 14.7 (14.9) million.
• Devices segment revenue decreased by 7.6 percent to EUR 5.4 (5.8) million.
• Software segment revenue increased by 2.8 percent to EUR 9.3 (9.0) million.
• EBITDA amounted to EUR -2.0 (-2.0) million corresponding to -13.3 (-13.5) percent of revenue.
• Optomed completed two directed share issues consisting of a total of 2,538,211 shares and collected gross proceeds of approximately EUR 8.9 million in 2022.
• Optomed aims to obtain the FDA clearance for its handheld fundus camera Aurora together with AEYE Health's AI for autonomous detection of more than mild diabetic retinopathy. Optomed announced the results from the prospective, multi-center clinical trial in February 2022, and it is currently working to address the additional data requests by the FDA.

Key figures

EUR, thousand Q4/2022 Q4/2021 Change, % 2022 2021 Change, %
Revenue 4,013 3,552 13.0% 14,660 14,850 -1.3%
Gross profit * 2,764 2,407 14.8% 10,069 10,558 -4.6%
Gross margin % * 68.9% 67.8% 68.7% 71.1%
EBITDA -347 -1,528 77.3% -1,952 -2,002 2.5%
EBITDA margin *, % -8.7% -43.0% -13.3% -13.5%
Adjusted EBITDA * -347 -1,528 77.3% -1,952 -2,002 2.5%
Adjusted EBITDA margin -8.7% -43.0% -13.3% -13.5%
*, %
Operating result -870 -2,182 60.1% -5,097 -4,780 -6.6%
(EBIT)
Operating margin -21.7% -61.4% -34.8% -32.2%
(EBIT) *, %
Adjusted operating -870 -2,182 60.1% -5,097 -4,780 -6.6%
result (EBIT) *
Adjusted operating -21.7% -61.4% -34.8% -32.2%
margin (EBIT margin)
*, %
Net profit/ loss -1,397 -1,936 27.8% -5,472 -4,249 -28.8%
Earnings per share -0.10 -0.14 33.8% -0.37 -0.32 -18.2%
Cash flow from -109 -484 77.5% -2,370 -2,940 19.4%
operating activities
Net Debt -3,251 213 -1,629.6% -3,251 213 -1,629.6%
Net debt/ Adjusted 1.7 -0.1 1.7 -0.1
EBITDA (LTM)
Equity ratio  * 65.0% 58.8% 65.0% 58.8%
R&D expenses personnel 348 419 -16.9% 1,198 1,773 -32.5%
R&D expenses other 182 121 50.1% 661 511 29.5%
costs
Total R&D expenses 530 540 -1.9% 1,859 2,284 -18.6%

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

CEO Review

Strong growth during the second half of the year enabled us to close the gap left by the drop in revenue from China. Good results from the Aurora AEYE clinical trial, additional work still needed to obtain the FDA clearance. The business focus is strongly on the Western markets.

The first half of Optomed's year was weak with a decrease of revenue in China by about EUR 1.5 million from the previous year. During the second part of the year, however, both of our business segments saw strong growth in revenue due to increased demand in the Western markets and several large solution deliveries. We expect strong demand in the Western markets to continue in 2023, and we actively strive to find new significant strategic customers and partnerships in China and other developing markets. The Covid situation in China and therefore the market is expected to finally improve after the latest pandemic wave passes in the country, likely in early 2023.

The most significant event of the year was the completion and publication of the clinical study of our Aurora-AEYE AI camera in the United States. We were very pleased with the results achieved, which enabled us to initiate the process towards FDA clearance. We see that the screening market for diabetic retinopathy in the US is now at its turning point due to the new reimbursement code (CPT 92229).

The FDA process of Aurora AEYE is on-going, and the FDA made the latest data requests late last year. Optomed aims to obtain all the necessary additional data and deliver it to the FDA together with the updated FDA clearance application during the coming months. For the company, it is crucial to do careful and comprehensive work in collecting and submitting the requested additional data to the FDA. We believe that the probability of getting the clearance is good with these actions. Although obtaining FDA clearance for medical devices utilizing diagnostic AI in the United States is particularly time-consuming and challenging, we strongly believe that these investments will pay off. The high quality standards and high market barriers in the US create trust in the customer base and provide strong protection against competition for solutions that have been cleared. The commercial potential of the solutions is very significant with the new reimbursement code (CPT 92229).

We have estimated that in the US in 5-10 years, there could be around 50,000 to 100,000 fundus cameras connected to diagnostic AI, screening for diabetic retinopathy and later other blinding eye diseases and systemic diseases. And we believe that within 5-10 years, most diabetic retinopathy screenings will be done in the US using AI. This is a significant opportunity and if the FDA clearance process is successful, Optomed will be in a unique position in this market disruption. Optomed's business model from these solutions will primarily be recurring revenue type.

Due to the significant growth potential and the FDA clearance we are targeting for our Aurora AEYE AI camera, we are heavily focusing our growth efforts in the US. We hired a significant number of new sales and marketing personnel in the US in 2022, resulting in a strong and capable organization in sales, marketing and customer service. We sell both our cameras and related software solutions through this organization. We have also started training and preparing our partners for the expected launch of our Aurora AEYE product. We see the US as our most significant growth market both in the short, medium and long term, with good prospects for success.

Elsewhere in the world, the company's costs have been decreasing. Our largest development projects are approaching the completion and, as a result, the company's fixed costs and investments will be slightly lower in the future outside of the USA. We have just launched commercial launch activities for our Avenue Flow software product for eye clinics. In addition, development work on our new device product is near completion, and we are preparing to start CE testing. The commercial introduction of the product will be made after it receives CE approval.

We will continue to implement our strategy with determination.

Seppo Kopsala

CEO

Outlook 2023

Optomed expects its full year 2023 revenue to grow compared to 2022.

Telephone conference

A telephone conference for analysts, investors and media will be arranged on 17 February 2023 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 235 776 314#.

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 2022

In October-December 2022, Group revenue increased by 13.0 percent to EUR 4,013 (3,552) thousand. Software segment revenue increased by 23.2 driven by a very strong quarter of the segment's healthcare business. Devices segment revenue decreased by 4.0 percent to EUR 1.3 (1.3) million after extremely strong growth of 45.4 percent in Q3.

The gross margin increased to 68.9 from 67.8 percent of last year. The gross margin for the fourth quarter of 2022 adjusted for grants and other operating income would have been 69.4 percent compared to the normalized 66.2 percent in 2021. The gross margin improvement was driven by the Devices segment where the gross margin improved especially in the US market.

EBITDA was EUR -347 (-1 528) thousand. The comparison period was affected by a credit risk accrual related to an overdue trade receivable from a customer in China. Approximately EUR 700 thousand of the difference is due to the credit risk accrual whereas the remaining improvement is mainly due to the improved gross profit.

Net financial items amounted to EUR -546 (226) thousand and consisted mainly of interest payments to financial institutions and the translation effect of Chinese RMB and USD to EUR.

January - December 2022

In January-December 2022, Group revenue decreased by 1.3 percent to EUR 14,660 (14,850) thousand. The Devices segment's revenue decreased by 7.6 percent and the Software segment's revenue increased by 2.8 percent. The decrease was mainly driven by the muted business in China where the revenue decreased approximately EUR 1.5 million.

The gross margin decreased to 68.7 percent from 71.1 percent last year. In January-December the Company's other operating income was EUR 857 (810) thousand. Other operating income includes EUR 841(538) thousand Business Finland loan waiver related to closed product development projects.  The gross margin for the period adjusted for the total amount of the grants and other operating income would have been 62.8 percent compared to 65.6 percent in 2021.

EBITDA amounted to EUR -1,952 (-2,002) thousand and EBIT was EUR -5,097 (-4,780) thousand. EBIT was affected by the impairment of the terminated product development program amounting to EUR 1,040 thousand. Increased staff costs especially in the US and decreased gross profit had a negative effect on EBITDA this year.

Net financial items amounted to EUR -454 (453) thousand and consisted mainly of interest payments to financial institutions and the translation effect of Chinese RMB and USD to EUR.

Cash flow and financial position

October - December 2022

In October-December 2022, the cash flow from operating activities amounted to EUR -109 (-484) thousand. Net cash used in investing activities was EUR -557 (-882) thousand and relates to capitalized development expenses. Net cash from financing activities amounted to EUR 3,531 (291) thousand. Optomed completed a directed share issue and collected gross proceeds of approximately EUR 4.1 million in December 2022.

Consolidated cash and cash equivalents at the end of the period amounted to EUR 8,524 (6,804) thousand. Interest-bearing net debt totalled EUR -3,251 (213) thousand at the end of the period.

Net working capital was EUR 3,738 (4,315) thousand at the end of the period.

The net working capital include trade receivables of EUR 3.6 (3.7) million. One Chinese customer represent approximately 50% of the total group trade receivables out of which approximately EUR 2.0 million is overdue, which after management's assessment have resulted in a credit risk accrual of EUR 589 thousand. This represents approximately 30% of the total outstanding trade receivable. 

January - December 2022

In January-December 2022, the cash flow from operating activities amounted to EUR -2,370 (-2,940) thousand. Net cash used in investing activities was EUR -3,029 (-2,574) thousand and relates to capitalized development expenses. Net cash from financing activities amounted to EUR 7,003 (1,637). Optomed completed two directed share issues consisting of combined total of 2,538,211 shares and collected gross proceeds of approximately EUR 8.9 million in 2022.
 

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).

EUR, thousand Q4/2022 Q4/2021 Change, % 2022 2021 Change, %
Revenue 1,275 1,329 -4.0% 5,398 5,839 -7.6%
Gross profit * 864 764 13.1% 3,738 4,139 -9.7%
Gross margin% 67.7% 57.5% 69.3% 70.9%
*
EBITDA -253 -1,198 78.9% -670 -1,014 33.9%
EBITDA margin -19.8% -90.2% -12.4% -17.4%
*, %
Operating -609 -1,698 64.2 % -3,159 -3,182 0.7%
result (EBIT)
Operating -47.7% -127.8% -58.5% -54.5%
margin (EBIT)
*, %

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

October-December 2022

In October-December 2022, the Devices segment revenue decreased by 4.0 percent to EUR 1,275 (1,329) thousand after extremely strong growth of 45.4 percent in Q3. Geographically, the US was the largest market where especially the OEM channel performed well. Chinese market remained very slow.

The gross margin was 67.7 (57.5) percent. The gross margin was supported especially by a project work for an OEM client and improved gross margins of the US business.

EBITDA was EUR -253 (-1,198) thousand or -19.8 (-90.2) percent of revenue. Approximately EUR 700 thousand of the delta is due to the credit risk accrual in 2021 whereas the remaining improvement is mainly due to the improved gross margin especially in the US.

January-December 2022

In January-December 2022, the Devices segment revenue decreased by 7.6 percent to EUR 5,398 (5,839) thousand. The decline was due to sales in China being approximately EUR 1.5 million lower than during the previous year.

The gross margin decreased to 69.3 percent from 70.9 percent in the previous year. Both review and comparison period had other operating income, and the twelve months' gross margin adjusted for this other operating income would have been 53.4 (57.0) percent. The gross margin was positively affected by a Business Finland loan waiver of 841 (538) thousand, and negatively affected by an inventory provision for non marketable items of 251 (0) thousand.

EBITDA was EUR -670 (-1,014) thousand or -12.4 (-17.4) percent of revenue. The staff cost increased especially in the US.

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.

EUR, thousand Q4/2022 Q4/2021 Change, % 2022 2021 Change, %
Revenue 2,738 2,223 23.2% 9,263 9,011 2.8%
Gross profit * 1,900 1,643 15.6% 6,330 6,420 -1.4%
Gross margin% 69.4% 73.9% 68.3% 71.2%
*
EBITDA 706 516 36.9% 2,079 1,855 12.1%
EBITDA margin 25.8% 23.2% 22.4% 20.6%
*, %
Operating 541 363 49.2% 1,431 1,247 14.7%
result (EBIT)
Operating 19.8% 16.3% 15.4% 13.8%
margin (EBIT)
*, %

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

October - December 2022

In October-December 2022, the Software segment revenue increased by 23.2 percent to EUR 2,738 (2,223) thousand. The increase was driven by very strong performance of the healthcare solution business.

Gross margin decreased slightly and was 69.4 (73.9) per cent. The decline was due to significant growth of healthcare solution business as opposed to consulting.

EBITDA was EUR 706 (516) thousand or 25.8 (23.2) percent of revenue.

January - December 2022

In January-December 2022, the Software segment revenue increased by 2.8 percent to EUR 9,263 (9,011) thousand.

EBITDA was EUR 2,079 (1,855) thousand or 22.4 (20.6) 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 2022

Group-wide operating expenses amounted to EUR 803 (846) thousand. The key driver for the decrease were the changes in group leadership team.

January - December 2022

Group-wide operating expenses amounted to EUR 3,368 (2,844) thousand.

Personnel

Number of personnel at the end of the reporting period.

12/2022 12/2021
Devices 48 50
Software 43 45
Group common 23 23
Total 114 118

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 October 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

Extraordinary General Meeting

On 6 September 2022, the Company organized an Extraordinary General Meeting as Board member Xisi Guo decided to leave the Board of Directors of Optomed on 19 August 2022. The Extraordinary General Meeting elected Mr. Mars Duan to the Board of Directors of the Company. Mars Duan is independent of the Company and dependent of a major shareholder.

The Board of Directors of Optomed Plc currently consists of the following persons: the Chairman Petri Salonen, Mars Duan, Seppo Mäkinen, Reijo Tauriainen and 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 16,541,355 shares and the Company held 374,566 shares in the treasury which approximately corresponds to 2.3 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 issues

In May 2022, Optomed completed a directed share issue consisting of 1,397,853 shares and collected gross proceeds of approximately EUR 4.8 million. 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.

In December 2022, Optomed completed another directed share issue consisting of a total of 1,140,358 shares. The Company received gross proceeds of approximately EUR 4.1 million as a result of the share issue. The main purposes of the share issue were to strengthen the Company's balance sheet and to ensure sufficient financing for the implementation of the Company's growth strategy especially in the US diabetic retinopathy screening market. The investors included Finnish qualified and institutional investors, including Keskinäinen Työeläkevakuutusyhtiö Elo as a new investor in the Company. The subscription price was EUR 3.56 per share, representing the last 30-day volume-weighted average trading price ("VWAP") of the share and, respectively, a premium of approximately 17.4 per cent compared to the three-month VWAP (EUR 2.94) of the share up to and including 9 December 2022. The subscription price represents a discount of approximately 15.4 per cent to the closing price of the Company's share on 9 December 2022. The subscription price was credited in full to the Company's reserve for invested unrestricted equity. 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 14 December 2022.

Risks and uncertainties

Optomed has reviewed its complete risk position after the year end of 2022. The complete risk position is as follows:

AURORA AEYE FDA CLEARANCE PROCESS

Optomed is in the process to obtain a US FDA clearance for its AI handheld camera Aurora AEYE

Optomed and its partner AEYE Health have a common goal to obtain the US FDA clearance for the handheld AI fundus camera Aurora AEYE. The Company has limited visibility to the FDA decision making process and the Company may be adversely affected if the process is delayed or requires significant additional work or investments from the Company.

PANDEMICS

The COVID-19 pandemic is still affecting Optomed's markets

The Company may be adversely affected if a new outbreak of COVID-19 or another disease causes a new pandemic. The COVID-19 pandemic is still affecting various countries.

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. In the PRC, "Made in China 2025" national strategic plan may have an effect on medical device manufacturers' sales to the public sector.

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. Global component sourcing issues make it harder to obtain the key components for the Company's medical devices.

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. Optomed has a large credit risk concentration related to a major Chinese customer whose payments are late. The payments from the customer continue but materially slower than originally agreed.

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 employeesthat 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.

Flagging notifications

28 January 2022 BI Asset Management Fondsmægler-selskab A/S notified that, the total holdings in Optomed shares and votes has decreased to 4.31 % of all of the registered shares in Optomed.

11 May 2022 Cenova Funds (Shanghai Cenova Innovation Venture Fund (Limited Partnership), Alnair Investment and Cenova China Healthcare Fund IV, L.P.) notified that the total holdings in Optomed shares and votes held by Cenova has decreased to 14.36 per cent of all of the registered shares in Optomed on 10 May 2022 as a result of Optomed's total number of shares increasing on the date.

2 December 2022 OP-Rahastoyhtiö Oy ("Notifier") notified that the total holdings in Optomed shares and votes held by the Notifier is 5.43 per cent of all of the registered shares in Optomed on 30 November 2022. The total holdings of the Notifier have not changed on 30 November 2022. Instead, the disclosure is made due to the merger of OP-Suomi Mikroyhtiöt and OP-Suomi Pienyhtiöt funds.

Other events

On 16 August.2022 Optomed announced that Optomed's board of directors has resolved upon a new option plan. The resolution is based on the authorization given by the general meeting of 10 May 2022. The total number of options of Option Plan 2022A is 250,000 and each option entitled to one share of the company. The options are offered to certain key employees. The purpose of the plan is to retain and incentivize key employees.  The subscription price is EUR 4.17 corresponding the closing price of 12 August 2022, and the subscription period is 1 January 2026 - 31 December 2027. The theoretical market value of one option under the plan 2022A is approximately EUR 1.771 per stock option and the theoretical total market value of the plan 2022A is approximately 442,750.00 euros in total. The theoretical market value of a stock option has been calculated by using the Black & Scholes stock option pricing model with the following input factors: share price EUR 4.04 euros, subscription price EUR 4.17, risk free interest rate 0.0%, validity of stock options approximately 3.4 years and volatility 64.07%.

• Vesa Vanha-Honko, OP funds
• Markus Lindqvist, Aktia funds
• Keith Bonnici, Finnish Industry Investment Ltd

Petri Salonen, Chairman of Optomed's Board of Directors, will serve as the Nomination Board's expert member.

The Board's proposal for the distribution of profit

The parent company's non-restricted equity on 31 December 2022, was EUR 23,858,348.30 and the net loss for the financial year was EUR 3,547,640.33. The Board of Directors proposes to the Annual General Meeting that no dividend will be paid and the non-restricted equity on the outstanding 16,541,355 shares shall be retained and carried forward. 

Audit review

This financial report has been audited by the Company's auditors.

• 5 May 2023 Interim Report for 1 January - 31 March 2023

• 4 August 2023 Half-Year Financial Report for 1 January - 30 June 2023

• 3 November 2023 Interim Report for 1 January - 30 December 2023

For more information, contact

Sakari Knuutti, CFO

Tel: +358 (0)50 562 4077

E-mail: sakari.knuutti@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 and screening software. 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.

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 result
excluding items
affecting
comparability
Adjusted operating Adjusted
margin, % operating
result /
Revenue
Adjusted EBITDA EBITDA
excluding items
affecting
comparability
Adjusted EBITDA Adjusted EBITDA
margin, % / Revenue
Items affecting Material items
comparability outside
ordinary course
of business
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 / Adjusted Net Debt /
EBITDA (LTM), times Adjusted EBITDA
(for the last
twelve months,
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

Consolidated income statement

In thousands of euro Q4/2022 Q4/2021 2022  2021
Revenue 4,013 3,552 14,660 14,850
Other operating income -22 57 857 810
Materials and services -1,227 -1,201 -5,449 -5,102
Employee benefit -2,378 -2,448 -8,827 -8,702
expenses
Depreciation, -523 -654 -3,145 -2,778
amortization and
Impairment losses
Other operating expenses -733 -1,486 -3,193 -3,858
Operating result -870 -2,182 -5,097 -4,780

Finance income 7 264 569 715
Finance expenses -553 -38 -1,024 -263
Net finance expenses -546 226 -454 453

Profit (loss) before -1,417 -1,956 -5,551 -4,327
income taxes

Income tax expense 20 20 79 78

Loss for the period -1,397 -1,936 -5,472 -4,249
Loss for the period
attributable to
Owners of the parent -1,397 -1,936 -5,472 -4,249
company
Loss per share
attributable to owners
of the parent company
Weighted average number 14,640,697 13,441,437 14,640,697 13,441,437
of shares
Basic loss per share -0.10 -0.14 -0.37 -0.32
(euro)

Consolidated condensed comprehensive income statement

In thousands of euro Q4/2022 Q4/2021 2022 2021
Loss for the period -1,397 -1,936 -5,472 -4,249
Other comprehensive income
Foreign currency translation difference 280 -119 139 -253
Other comprehensive income, net of tax 280 -119 139 -253
Total comprehensive loss attributable -1,117 -2,055 -5,333 -4,502
to Owners of the parent company

Consolidated balance sheet

In thousands of euro December 31, 2022 Dec 31, 2021
ASSETS
Non-current assets
Goodwill  4,256  4,256
Development costs  6,562  6,338
Customer relationships  1,164  1,386
Technology  534  636
Other intangible assets  379  358
Total intangible assets  12,895  12,975
Tangible assets  852  433
Right-of-use assets  1,448  1,205
Deferred tax assets  15  13
Total non-current assets  15,210  14,626
Current assets
Inventories  2,998  2,936
Trade and other receivables 4,568 4,631
Cash and cash equivalents  8,524  6,804
Total current assets  16,090  14,371

Total assets  31,300  28,998

In thousands of euro December 31, 2022 Dec 31, 2021
EQUITY
Share capital  80  80
Share premium  504  504
Reserve for invested non-restricted equity  46,896  38,526
Translation differences 51 -88
Retained earnings -21,717 -17,721
Profit (loss) for the financial year -5,472 -4,249
Total equity  20,342  17,052
LIABILITIES
Non-current liabilities
Borrowings from financial institutions  3,380  3,813
Government loans  906  1,940
Lease liabilities  1,058  818
Deferred tax liabilities  387  463
Total Non-current liabilities  5,731  7,034

Current liabilities
Borrowings from financial institutions  794  1,071
Government loans  193  193
Lease liabilities  412  396
Trade and other payables 3,828 3,252
Total current liabilities  5,227  4,912

Total liabilities  10,957  11,946

Total equity and liabilities  31,300  28,998

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 38,526 -88 -21,970 17,052
January 1,
2022
Comprehensive
income
Loss for the -5,472 -5,472
period
Other
comprehensive
income
Translation 139 139
differences
Total 139 -5,472 -5,333
comprehensive
income for
the period
Share issue  8,371 8,371
Share options 253 253
Total 8,371 253 8,624
transactions
with owners
of the
company
Other 0 
adjustments
Balance at 80 504 46,896 51 -27,189 20,342
December
31, 2022

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 37,470 166 -18,147 20,073
January 1,
2021
Comprehensive
income
Loss for the -4,249 -4,249
period
Other
comprehensive
income
Translation -253 -253
differences
Total -253 -4,249 -4,502
comprehensive
income for
the period
Share issue 0 
Share options  1,055 340 1,395
Total 1,055 340 1,395
transactions
with owners
of the
company
Other 86 86
adjustments
Balance at 80 504 38,526 -88 -21,970 17,052
December
31, 2021

Consolidated cash flow statement

In thousands of euro Q4/2022 Q4/2021 2022 2021
Cash flows from operating activities
Loss for the financial year -1,397 -1,936 -5,472 -4,249
Adjustments:
Depreciation, amortization and 523 565 3,145 2,689
impairment

losses
Finance income and finance expenses 618 -206 618 -472
Other adjustments -19 671 -770 454
Cash flows before change in net -275 -906 -2,479 -1,579
working capital
Change in net working capital:
Change in trade and other receivables 164 248 204 -1,409

(increase (-) / decrease (+))
Change in inventories -250 -9 -68 -340

(increase (-) / decrease (+))
Change in trade and other payables 320 235 172 516

(increase (+) / decrease (-))
Cash flows before finance items -42 -432 -2,171 -2,811
Interest paid -16 -27 -76 -66
Other finance expenses paid -51 -25 -123 -64
Interest received 0 0 0 1
Net cash from operating activities (A) -109 -484 -2,370 -2,940
Cash flows from investing activities
Capitalization of development expenses -518 -789 -2,249 -2,112
Acquisition of tangible assets -39 -92 -780 -462
Net cash used in investing activities -557 -882 -3,029 -2,574
(B)
Cash flows from financing activities
Proceeds from share subscriptions 4,060 149 9,012 1,012
Share issue transaction costs -300 0 -682 0
Proceeds from loans and borrowings 0 367 0 1,366
Repayment of loans and borrowings -124 -124 -912 -327
Repayment of lease liabilities -105 -100 -415 -414
Net cash from financing activities (C) 3,531 291 7,003 1,637
Net cash from (used in) operating, 2,865 -1,075 1,605 -3,876
investing and financing activities
(A+B+C)

Cash and cash equivalents at beginning 5,668 7,827 6,804 10,608
of period
Effect of movements in exchange rate -9 52 115 73
on cash held
Cash and cash equivalents at end of 8,524 6,804 8,524 6,804
period

*Comparison figures for 2021 numbers have been corrected in Operating activities category.

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 report also takes into account the amendments to IFRS standards that have become effective by January 1, 2022. 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.

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

The Russian invasion of Ukraine has not had a material effect on Optomed's business as the sales to the area have been limited.                           

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

Q4/2022

In thousands of euro Devices Software Group Admin Total
External revenue  1,275  2,738 0  4,013
Net operating expenses -411 -838 0 -1,249
Margin 864 1,900 0  2,764
Depreciation and amortization -356 -165 -2 -523
Other expenses -1,117 -1,194 -801 -3,111
Operating result -609 541 -803 -870
Finance items 0 0 -546 -546
Loss before tax expense -609 541 -1,349 -1,417

Q4/2021

In thousands of euro Devices Software Group Admin Total
External revenue  1,329  2,223 0  3,552
Net operating expenses -565 -579 0 -1,144
Margin 764 1,643 0  2,407
Depreciation and amortization -500 -153 -1 -654
Other expenses -1,962 -1,127 -845 -3,935
Operating result -1,698 363 -846 -2,182
Finance items 0 0 226 226
Loss before tax expense -1,698 363 -620 -1,956

2022

In thousands of euro Devices Software Group Admin Total

External revenue  5,398  9,263 0  14,660
Net operating expenses -1,659 -2,933 0 -4,592
Margin 3,738 6,330 0  10,069
Depreciation and amortization -2,489 -649 -8 -3,145
Other expenses -4,408 -4,251 -3,361 -12,020
Operating result -3,159 1,431 -3,368 -5,097
Finance items 0 0 -454 -454
Loss before tax expense -3,159 1,431 -3,823 -5,551

In thousands of euro Devices Software Group Admin Group
External revenue  5,839  9,011 0  14,850
Net operating expenses -1,700 -2,592 0 -4,292
Margin 4,139 6,420 0  10,558
Depreciation and amortization -2,168 -608 -2 -2,778
Other expenses -5,153 -4,565 -2,843 -12,561
Operating result -3,182 1,247 -2,844 -4,780
Finance items 0 0 453 453
Loss before tax expense -3,182 1,247 -2,392 -4,327

2021

 Revenue

In thousands of euro Q4/2022 Q4/2021 2022  2021
Finland 2,454 2,262 8,606 58.7%  8,939 60.2%
Rest of the Europe  462 375 1,715 11.7%  1,162 7.8%
Rest of the World  1,097 915 4,340 29.6%  4,749 32.0%
Total  4,013 3,552  14,660 100% 14,850 100%

Other operating income

In thousands of euro Q4/2022 Q4/2021 2022 2021
Other operating income -22 57 857 810
Total -22 57 857 810

Other operating income consist of Business Finland waived loan (841 thousand), received grants and profit from sales of fixed assets. During the financial years 2021-2022 Optomed has received government grants from various organizations, such as Business Finland.

Other operating expenses

Other operating expenses Q4 2022 Q4 2021 2022 2021
Sales and marketing -206 -229 -784 -674
Research and development -62 -24 -361 -412
General and administration -464 -1,233 -2,049 -2,772
Total operating expenses -733 -1,486 -3,193 -3,858

Other operating expenses also comprise changes in expected credit losses and realized credit losses. For the comparison period 2021 a specific credit loss accrual of EUR 715 thousand has been recorded which can be seen in general and administration cost line.

Tangible assets

 In thousands of euro Machinery and equipment Machinery and equipment
2022 2021
Cost
Balance at January 1  2,721  2,257
Additions  791  464
Balance at End of  3,512  2,721
Period

Accumulated
depreciation and
impairment losses
Balance at January 1 -2,288 -1,898
Depreciation -372 -390
Balance at end of -2,660 -2,288
period

Carrying amount at  433  359
January 1
Carrying amount at   852  433
December 31

Leases

Leased tangible assets
In thousands of euro 2022 2021

Additions to right-of-use assets  671  449
Depreciation charge for right-of-use assets -428 -409
Carrying amount at the end of the reporting period 1,448 1,205
Leased tangible assets comprise business premises.
Lease liabilities
In thousands of euro 2022 2021

Current  412  396
Non-current  1,058  818
Total  1,470  1,214

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 Goodwill Development Customer Technology Other Total
31 2022 costs relationships intangible
assets
In thousands
of euro
Cost
Balance at  4,256  11,815  2,222  1,023  951  20,267
January 1
Additions  0    2,163  0    0    103  2,266
Balance at  4,256  13,978  2,222  1,023  1,054  22,533
December 31
Accumulated  -  
amortisation
and
impairment
losses
Balance at  0   -5,477 -836 -387 -593 -7,292
January 1
Amortization  0   -899 -222 -102 -83 -1,306
Impairment  0   -1,040  0    0    0   -1,040
losses
Balance at  0 -7,416 -1,057 -489 -676 -9,638
December 31
 -  
Carrying  4,256  6,338  1,386  636  358  12,975
amount at
January 1
Carrying  4,256  6,562  1,164  534  379  12,895
amount at
December 31

At December Goodwill Development Customer Technology Other Total
31 2021 costs relationships intangible
assets
In thousands
of euro
Cost
Balance at  4,256  9,709  2,222  1,023  945  18,156
January 1
Additions 0   2,105 0 0  6  2,111
Balance at  4,256  11,815  2,222  1,023  952  20,267
December 31
Accumulated  -  
amortisation
and
impairment
losses
Balance at 0   -4,043 -614 -286 -461 -5,403
January 1
Amortization 0 -952 -222 -102 -43 -1,319
Impairment 0 -482 0 0  -89  -571
losses
Balance at 0 -5,477 -836 -387 -593 -7,292
December 31
 -  
Carrying 4,256  5,667  1,608  738  485  12,753
amount at
January 1
Carrying 4,256  6,338  1,386  636  358  12,975
amount at
December 31

Financial assets

Current financial assets
In thousands of euro 2022 2021

Trade receivables
Recourse factoring  324  740
Other trade receivables 3,232 2,917
Total trade receivables  3,556  3,658
Cash and cash equivalents  8,524  6,804
Total  12,080  10,462

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. Planned schedule was renegotiated in October. Chinese customer has paid its overdue receivables according to planned schedule.

In thousands Gross carrying amount Weighted av. Loss
of euro
loss rate% allowance

At December
31, 2022
Current (not                    0.5%                    8  
past due) 1,664  
Past due
1-30 days                       1.5%                    2  
161  
31-60 days                           4%                    0  
7  
61-90 days                         9%                    3  
29  
More than 90                         12%                    1  
days past due 12  
Specific loss                    30%                589  
allowance 1,962  
Total                                   604  
3,836  

In thousands of euro Gross carrying amount Weighted av. Loss

loss rate% allowance

At December 31, 2021
Current (not past due)  1,143 0.5% 6
Past due
1-30 days  67 1.5% 1
31-60 days  10 4% 0
61-90 days  2 9% 0
More than 90 days past due  40 12% 5
Specific loss allowance  2,382 30% 715
Total  3,644  727

Financial liabilities

In thousands of euro  31.12.2022  31.12.2021 

Non-current financial liabilities 
Borrowings from financial institutions  3,380 3,813
Government loans  906 1,940
Lease liabilities  1,058 818
Total  5,344 6,571

Current financial liabilities 
Borrowings from financial institutions  794 1,071
Government loans  193 193
Lease liabilities  412 396
Trade payables  869 944
Total  2,268 2,604
  
Total financial liabilities  7,612 9,175

Business Finland loan amount of 841 thousand was waived during Q3 2022.

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.

Financial covenants

Optomed's borrowings from financial institutions contain a financial covenant (equity ratio) and Optomed also has to meet certain key operative targets. During the financial year 2022 the Group adjusted the repayment schedule for borrowings from financial institutions. Loan payment exemptions were taken while the loan payment periods remain the same.

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
Nordea loan
At December 31. 2022
Equity ratio 50% 62.1% Optomed Group
Cash amount 2 million 8.5 million Optomed Group
At December 31, 2021
Equity ratio 50% 56.4% Optomed Group
Cash amount 2 million 6.8 million Optomed Group
OP loan equity ratio
At December 31, 2022 35% 66.1% Optomed Group
At December 31, 2021 35% 59.0% Optomed Group

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 December 31, 2022.

Related party transactions

In thousands of euro Revenues Trade receivables Other expenses
Jan 1 - Dec 31 2022 0 0 -80
Jan 1 - Dec 31 2021 1,704 2,382 -87

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. Related parties: due to changes in the board of directors, the owners will no longer be related parties in 2022.
 

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

Events after the review period

No material events after the reporting period.