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Inify Laboratories AB Interim / Quarterly Report 2024

Apr 24, 2024

6123_10-q_2024-04-24_816c8ab0-5cb5-49d2-ab9e-5181c8baf798.pdf

Interim / Quarterly Report

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Inify Laboratories

Interim report for the first quarter 2024

2 Inify Laboratories AB – 559345-4431 Interim report for the first quarter 2024

This is Inify Laboratories

What we do

Inify Laboratories provides cancer diagnostics in histopathology, initially for diagnosis prostate cancer. We have built an ultramodern laboratory, offering diagnostic services to both public and private healthcare providers. The business model and technical structure allow for scalability in volume, diagnosis and geographical expansion.

How we do it

We have built an ultramodern laboratory and developed a unique structure of systems and processes that enable a fully digital, standardized and AI-assisted workflowm in order to optimize quality and shorten response times. We offer services for selected cancer types, where specialization contributes to high and reliable quality.

Why we do it

Clinical pathology is currently under great pressure, with high workloads and limited – even declining – resources in many parts of the world. An aging population, increasing cancer incidence, and more frequent examinations and screening programmes further increase the workload. Solving the problem through labor alone is not an option, due to the acute shortage of medical staff in pathology. It is simply necessary to work in new ways.

Who we are

Inify Laboratories is based in Sweden and became independent in 2022 through a spin-off from ContextVision, which has 40 years of experience in digital images for medical diagnostics. The company is listed on Euronext Growth Oslo.

Our vision: World leading cancer diagnostics for everyone!

Inify Laboratories AB – 559345-4431 3 Interim report for the first quarter 2024

First quarter highlights

  • Operating income of 2.2 MSEK
  • Contiuous on-boarding of new customers
  • Cash position period-end of 59.2 MSEK
Key figures Q1 2024 Q1 2023 Full year 2023
Average number of shares 45,236,750 45,236,750 45,236,750
Earnings per share (SEK) -0.26 -0.31 -1.18
Solidity 88.9% 94.6% 91.4%
Net sales (TSEK) 2,419 0 1,193
EBITDA (TSEK) -11,337 -12 905 -51,401

The company use some figures that are considered as Alternative Performance Measures. Please see description under section Alternative Performance Measures and Definitions.

4 Inify Laboratories AB – 559345-4431 Interim report for the first quarter 2024

Letter from the CEO

Significant increase in turnover and number of diagnoses

In the first quarter of 2024, we see a growth in sales of as much as 184% compared to the previous quarter. This is an effect of the fact that a number of customers joined late in the fourth quarter of 2023, after attained accreditation. More diagnoses were delivered in the first quarter alone than in the whole of 2023. Net sales amounted to SEK 2.2 million and the cash balance at the end of the quarter was SEK 59.2 million

Customers

Our existing customers are mainly located in the Stockholm region, which means that we can work closely with a high onsite presence. This provides us with important feedback that helps us sharpen our own processes while optimizing customer workflows, such as digital referrals and reports. The growth we see in the number of samples and turnover is a clear acknowledgement of the value we create and the trust we build with our customers.

Nhe 2023 quality report from the National Prostate Cancer Registry (NPCR) for the Stockholm-Gotland region was recently published. The report already indicates the positive effects of our contribution to shortening patient wait times.

We are experiencing a great deal of interest from new customers. During the quarter, we have worked intensively on preparations to onboard a number of these, and we expect continued strong growth during the year. Dialogues with new customers include both public and private healthcare providers, as structures for healthcare delivery vary between regions in the country.

In March, an article about our laboratory

service was published in Prostatanytt, a magazine linked to the Prostate Cancer Association, which is the Swedish patient association for prostate cancer. It describes how our innovative service, in close collaboration with urology clinics, creates significant added value for urology providers and their patients.

International mapping

In parallel with our establishment in Sweden, our evaluation of selected markets in Europe is ongoing. We primarily focus on countries that are able to initially send patient samples to Sweden, which gives us a good basis for a decision whether to establish laboratory operations in each country. Long, unpredictable response times and varying quality pose great challenges for most countries, and the number of cases of prostate cancer globally is expected to increase significantly by 2040. This, together with the knowledge we acquire through mapping markets outside Sweden, strengthens our conviction of successful international expansion.

Organization

We continue to grow our organization and

have both welcomed new colleagues and signed agreements with colleagues who will join us later in the year. Our team has been strengthened with employees in marketing, diagnostics, customer support and laboratory expertise. This is fully in line with our plans and means that we are well staffed for the growth we see ahead.

Outlook

Another successful quarter has passed, and our progress is fully in line with our development plan. We are inspired by the fact that we are now in an intense growth phase, and are motivated by the confirmation we receive regarding the significant value we add for caregivers and patients, on a daily basis.

With yet another strong quarter behind us, I, along with the whole team, look forward with great optimism to our continued development and growth journey.

Fredrik Palm Chief Executive Officer

First quarter 2024

Company history and development

Inify Laboratories AB (publ) is a Swedish company with it's registered office in Stockholm, Sweden. The company was incorporated in November 2021 as a subsidiary to ContextVision AB. After a resolution at an extraordinary general meeting in December 2021, Inify Laboratories was spun-off by a dividend of shares that was carried out in February 2022. During 2022 the company built it's first laboratory and office facilities, and moved in at the end of 2022. During January 2023 a wholly owned subsidiary was formed, to support the business structure with a suitable organization. The laboratory launched it's pathology services for healthcare providers in mid June 2023, focusing on prostate cancer for a start.

Inify Laboratories Group

The group consists of the parent company Inify Laboratories AB (publ), company registration number 559345-4431, and the wholly owned subsidiary Inify Laboratories Nordics AB, company registration number 559416-6828.

The subsidiary was formed in January 2023 and its' business primarily consists of running the daily laboratory and diagnostics operations in the group's first laboratory in Solna, Sweden. The parent company's business consists of conducting research and development, managing the intangible assets, group management and other administrative services at the group level.

Transactions which are eliminated on consolidation

Internal group receivables and liabilities, income or expense and unrealised gains or losses which arise from intra-Group transactions among group comapnies, are eliminated in the preparation of the consolidated financial statements. As of the balance sheet date 31 March 2024, there were group receivables in the parent company of a total of SEK 3.4 million relating to the subsidiary.

Financial development

During the first quarter of 2024, Inify's operating income amounted to SEK 2,229 thousand (0) and other income amounted to SEK 190 thousand, which corresponds to an increase of 184% in operating income compared to the previous quarter. The large increase in revenue is due to the new customers who joined late in the fourth quarter of 2023, that started delivering patient samples on a full-scale in the first quarter

of 2024. All operating income relates to diagnostic services in Sweden and were invoiced in SEK. Other income relates to the sale of a non-current asset.

The Group's costs consist mainly of personnel costs and other external costs, but whilst revenues increase, the cost of goods is expected to increase proportionally. The increase in personnel costs compared with the previous year is a natural consequence of the growth of the organi-zation and the hiring of new employees.

Operating results

Inify's consolidated operating result for the first quarter 2024 was SEK -12.5 million (-14.0) and results after financial items was SEK -11.9 million (-13.8). EBITDA for the period was SEK -11.3 million (-12.9).

Cash-flow and financing

Prior to the spin-off from the former parent company (ContextVision) in February 2022, assets were transferred from the parent company to Inify Laboratories with a total value of SEK 31.3 million. The assets transferred included tangible assets amounting to SEK 0.7 million, intangible assets amounting to SEK 10.1 million and bank funds of SEK 20.5 million. Following a general meeting resolution from 9 may 2022 a private placement and a subsequent offering of NOK 150 million was carried out, to secure long term funding for the company. The raised capital was paid to the company during July 2022. Cash and bank assets for the group at 31 March 2024 amounted to SEK 59.2 millions (108.6). Cash flow for the first quarter was SEK -11.7 millions (-20.0). Equity at period end amounted to SEK 73.1 millions (124.6), resulting in an equity ratio of 88.9% (94.6%).

Tangible and intangible assets

For tangible and intangible assets a depreciation period of 5 years is applied.

Tangible assets at period end amounted to SEK 9.5 millions (10.4).

The intangible assets consist of the product Inify Prostate™, a decision support tool for prostate cancer diagnosis. It was initially developed by ContextVision, and was aquired and further developed by Inify Laboratories. It now serves as a fully integrated component in the internally developed laboratory information system. Intangible assets at period end amounted to SEK 5.7 millions (7.7).

Inventories

Inventories are valued at the lower of cost and net realisable value. The cost of inventories is calculated through the application of the first in, first out method (FIFO). Inventories at period end amounted to SEK 437 thousands (0).

Leasing

The companyleases a combined office and laboratory facility on Campus Solna, which houses both the first laboratory and the Group's headquarters. Inify has also signed a lease for an office facility in Linköping, primarily intended for R&D activities. In addition, there are some smaller leasing commitments for vehicles, office equipment and laboratory equipment.

Employees

At March 31st, 2024 the group had 23 (19) employees in total, all located in Sweden. Of these, 19 (19) were employed by the parent company and 4 (0) by the subsidiary.

Incentive program

The Company's general meeting resolved on 9 May 2022 to implement a long-term incentive program for employees (the "Employee Incentive Program") and a long-term incentive program for board members (the "Board Member Incentive Program"). The long-term incentive program consists of a maximum of 3,935,599 options, divided between the Employee Incentive Program and the Board Member Incentive Program. Assuming that all options are exercised, this will correspond to a total dilution of approximately 8% based on the number of outstanding shares at the date of this report. Each option entitles the holder to acquire a new share or a warrant entitling to one share in the Company at an exercise price of NOK 4.80. The granted options vests over a 36-month period and may, as a general rule, only be exercised for the acquisition of new shares if the participant is still employed and the other conditions for qualified employee stock options under the Income Tax Act are met. The holder of options may exercise granted and vested options during the period from the end of the vesting period up to and including the tenth year from the date of grant.

Risks and uncertainties

The major risk factors and uncertainties for the company comprise, but are not limited to, risks related to the business and industry in which the Company operates, legal and regulatory risks, risks related to the Issuer's financial situation and risks relating to the shares and the listing of the shares

on Euronext Growth Oslo. In addition to above, the management closely monitor and regularly evaluates any risk that could arise from inflation, increasing energy prices or international instability. For further details on the company's major risk factors, please see the Information Document that was published in connection with the listing on Euronext Growth in June 2022 and the Annual Report 2023 that was published on April 11, 2024. The risks and uncertainties have not changed significantly since then.

Related party transactions

Transactions between the parent company and its subsidiary arise naturally in the operations when, for example, premises and certain resources are shared between the companies. The group transactions have mainly concerned the invoicing of rents and services shared between the companies. During the first quarter, the total intra-group revenue of the Parent Company amounted to SEK 545.

Except from above, there has been no other significant transactions with related parties during the period.

Basis of preparation

The condensed financial statements for the first quarter 2024, ending March 31st 2024 have been prepared in accordance with the Swedish Accounting Board's general advice BFNAR 2012:1 Annual accounts and consolidated accounts ("K3"). The condensed financial statements do not include all the information and disclosures required in the annual financial statements.

The functional and reporting currency of the group is Swedish krona (SEK). All amounts, unless otherwise stated, are presented in SEK thousand.

New and changed accounting principles

No new or changed accounting principles have had effect on the accounting for the period.

Subsequent events

During the period between period-end and the issuance of this report no significant events have occurred.

Shareholder information

  • Inify Laboratories AB is listed on Euronext Growth Oslo under the ticker INIFY (ISIN SE0017486103).
  • The company has a total of 45,236,750 shares outstanding. All shares have equal rights and are freely transferable.
  • At March 31st, Inify had a total of 1,115 share holders, whereof 2 share holders held more than 10% each of the shares.
  • Detailed information on major shareholders can be found on the company's website www.inify.com.
  • The 5 largest shareholders as of March 31st, 2024 are listed in the table below.
No of shares % Shareholder
1 27,181,386 60.09 Gallivant S.á.r.l.
2 4,691,412 10.37 Tauri AS
3 1,964,768 4.34 Günther-Hanssen, Sven
4 1,879,709 4.16 Danske Bank A/S
5 1,382,243 3.06 MP Pensjon PK

Financial calendar

This interim report was published on the company's website on the 24th of April 2024. For further information, please visit www.inify.com.

29 February 2024 Publication of Q4 and full year 2023
Financial report
11 April 2024 Publication of Annual Report 2023
24 April 2024 Publication of Q1 2024 Financial report
14 May 2024 Annual General Meeting
21 August 2024 Publication of Q2 2024 Financial report
23 October 2024 Publication of Q3 2024 Financial report
26 February 2025 Publication of Q4 and full year 2024
Financial report

Inify Laboratories AB – 559345-4431 9 Interim report for the first quarter 2024

Key figures SEK 1000

Q1 2024 Q1 2023 Full year 2023
Number of shares at period end 45 236 750 45 236 750 45 236 750
Average number of shares 45 236 750 45 236 750 45 236 750
Earnings per share -0.26 -0.31 -1.18
Solidity (percent) 88.9% 94.6% 91.4%
EBITDA -11 337 -12 905 -51 401

The company use some figures that are considered as Alternative Performance Measures.

Please see description under section Alternative Performance Measures and Definitions.

Consolidated income statement in summary SEK 1000

Q1 2024 Q1 2023 Full year 2023
Net sales 2 229 0 1 193
Other income 190 0 0
Total operating income 2 419 0 1 193
Cost of goods -466 0 -341
Other external costs -5 321 -6 175 -22 911
Personnel costs -7 970 -6 731 -29 342
Depreciation -1 127 -1 053 -4 359
Operating results -12 464 -13 958 -55 760
Interest income 609 157 2 435
Interest cost -52 0 0
Results after financial items -11 907 -13 798 -53 325
Tax 0 0 0
Net results -11 907 -13 798 -53 325

Consolidated statement of comprehensive income SEK 1000

Q1 2024 Q1 2023 Full year 2023
Net result for the period -11 907 -13 798 - 53 325
Other comprehensive income
Other comprehensive income that may be reclassified
to profit or loss in subsequent periods (net of tax)
0 0 0
Total comprehensive income -11 907 -13 798 -53 325

Consolidated balance sheet in summary SEK 1000

Assets March 31, 2024 March 31, 2023 December 31,
2023
Intangible fixed assets 5 718 7 737 6 223
Tangible assets 9 514 10 532 9 144
Other financial assets 875 875 875
Inventories and other current assets 437 102 272
Current receivables 6 546 3 812 5 633
Cash and bank 59 160 108 556 70 853
Total assets 82 250 131 614 93 000
Equity and liabilities
Equity 73 140 124 574 85 046
Current liabilities 9 110 7 040 7 954
Total equity and liabilities 82 250 131 614 93 000

Consolidated change in equity in summary SEK 1000

Q1 2024 Q1 2023 Full year 2023
Opening balance 85 046 138 372 138 372
Total comprehensive income for the period -11 907 -13 798 -53 326
Contributed Capital 0 0 0
New shares issue 0 0 0
Total 73 140 124 574 85 046

Parent company income statement in summary SEK 1000

Q1 2024 Q1 2023 Full year 2023
Net sales 545 0 946
Other income 190 0 0
Total operating income 736 0 946
Cost of goods 0 0 -102
Other external costs -4 923 -6 056 -21 858
Personnell costs -6 965 -6 731 -28 092
Depreciation -1 119 -1 050 -4 333
Operating results -12 271 -13 837 -53 439
Interest income 609 157 2 434
Interest cost -52 0 0
Other financial items 0 0 -2 321
Results after financial items -11 714 -13 681 -53 326
Tax 0 0 0
Net results -11 714 -13 681 -53 326

Parent company balance sheet in summary SEK 1000

March 31, 2024 March 31, 2023 December 31,
Assets 2023
Intangible fixed assets 5 718 7 737 6 223
Tangible assets 9 394 10 382 9 016
Other financial assets 1 117 1 043 925
Inventories and other current assets 0 102 0
Current receivables 8 484 5 694 7 721
Cash and bank 56 829 106 510 68 527
Total assets 81 542 131 467 92 412
Equity and liabilities
Equity 73 332 124 692 85 046
Current liabilities 8 210 6 775 7 366
Total equity and liabilities 81 542 131 467 92 412

Parent company change in equity in summary SEK 1000

Q1 2024 Q1 2023 Full year 2023
Opening balance 85 046 138 372 138 372
Total comprehensive income for the period -11 714 -13 681 -53 326
Contributed Capital 0 0 0
New shares issue 0 0 0
Total 73 332 124 692 85 046

Signatures

The board and the CEO certify that this interim report for the period 1 January – 31 March 2024 to the best of our knowledge, includes a fair and true review of the company's significant events, operations, financial position, results and related party transactions, and also describes the significant risks and uncertainties that the company faces. This report has not been reviewed by the company's auditors.

Stockholm, 23 April, 2024

Olof Sandén Chairman of the board Fredrik Palm CEO

Martin Ingvar Boardmember

Magne Jordanger Boardmember

14 Inify Laboratories AB – 559345-4431 Interim report for the first quarter 2024

Alternative performance measures and definitions

In its financial reports, the company presents certain financial measures, including Key Figures, which are considered as Alternative Performance Measures (APM). The company believes that these figures provide useful supplementary information to investors and the company's board and management as they enable a better evaluation of the company's financial performance. Because not all companies calculate the financial figures in the same way, these are not always comparable to measures used by other companies.

Key figure Definition Motivation for usage
Earnings per share after tax
(Return on equity)
Net result for the period divided by the
number of outstanding shares at period end.
Earnings per share shows the company's
results in relation to shares, and provides
additional information regarding the company's
profitability.
Solidity (Equity ratio) Equity at period end as a percentage of total
assets.
The equity ratio shows the company's long term
ability to pay its debts and is a complement to
other key figures. It helps assess the possibility
of dividends.
EBITDA Earnings before interest, taxes, depreciation
and amortization. Operating profit/loss before
interest, taxes, impairment and depreciation/
amortization.
EBITDA shows the company's underlying
development, which is valuable as an indication
of the company's underlying cash-generating
capacity.

Definitions

Accreditation

Accreditation is a formal recognition that an organization is competent to perform specified tasks in testing, inspection and certification.

Artificial Intelligence (AI)

Artificial Intelligence is the intelligence exhibited by machines or software.

Biopsy

A small tissue sample taken with a hollow needle.

Digital Pathology

Digital pathology refers to the digital images of histopathology samples. The digitalization is achieved by scanning the prepared samples.

Histopathology

Examination of tissue specimens to study the visible manifestations of disease.

Image analysis

Processing a digital image in order to describe/classify its contents or to extract quantitative measurements.

LIS

Laboratory Information System

Machine Learning

Machine learning is the study of computer algorithms that automatically improve through experience.

Pathology report

A medical report provided to the referring physician that describes the characteristics of a piece of tissue, blood, or body organ that has been removed from the body.

Referral/request

Order from a physician for a diagnostic examination of a specimen of tissue or other samples from a patient.

Specimen

Part of a human body (e.g., Biopsy Specimen) or organ that is to be examined by the laboratory.

© 2024 Inify Laboratories

Inify Laboratories provides cancer diagnostics through ultra-modern laboratory services within histopathology. Fully digital, standardized and AI-supported workflow is applied to optimize quality and response times, initially for prostate cancer. The concept is scalable and extendable to other diagnosis. The company origins from ContextVision and became independent in February 2022. The company is based in Sweden and listed on Euronext Growth Oslo under the ticker INIFY.