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CellaVision Interim / Quarterly Report 2021

Oct 22, 2021

3025_10-q_2021-10-22_3dab3cc4-83e9-4fec-92f0-425534290c6c.pdf

Interim / Quarterly Report

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CellaVision Interim report Q3 January - September 2021

Strong sales and earnings growth in line with improving market conditions

Organic sales growth: Q3, 2021: 52% (-24)

EBITDA margin: Q3, 2021: 32% (28)

"As the pandemic subsides, we are accelerating activities, increasing manufacturing capabilities, reactivating paused projects and resuming our geographical expansion plans."

Simon Østergaard, President and CEO
Jul-Sep Jan-Sep Jan-Dec
(MSEK) 2021 2020 2021 2020 2020
Net sales 132.0 88.0 401.4 340.5 471.4
Gross profit 91.3 57.0 277.8 227.2 313.0
EBITDA 42.4 24.6 135.7 102.1 142.9
EBITDA margin, % 32 28 34 30 30
Profit/loss before tax 32.7 15.9 107.3 75.8 112.2
Total cash flow 20.0 -21.2 8.5 -8.3 0.9
Equity ratio, % 67 62 67 62 64

1 July-30 September 2021

  • Net sales increased by 50% to SEK 132 million (88).
  • Sales increased organically by 52% (-24), currency effect -2%
  • EBITDA amounted to SEK 42 million (25).
  • EBITDA margin amounted to 32% (28).
  • Profit before tax amounted to SEK 33 million (16).
  • Earnings per share before and after dilution were SEK 1.09 (0.56).
  • Cash flow from operating activities amounted to SEK 49 million (-4).

1 January-30 September 2021

  • Net sales increased by 18% to SEK 401 million (340).
  • Sales increased organically by 24% (-12), currency effect -6%.
  • EBITDA amounted to SEK 136 million (102).
  • EBITDA margin amounted to 34% (30).
  • Profit before tax amounted to SEK 107 million (76).
  • Earnings per share before and after dilution were SEK 3.59 (2.55).
  • Cash flow from operating activities amounted to SEK 114 million (46).

CEO's comment

The effects of the COVID-19 pandemic continued to diminish in Europe and North America during the quarter. In Asia we have seen new or maintained restrictions, which have slowed down recovery in this region.

Simon Østergaard President and CEO

The third quarter in brief

Sales for the Group amounted to SEK 132 million (88), representing an organic growth of 52 percent. The Group's total cash flow for the quarter amounted to SEK 20 million (-21). Operating cash flow amounted to SEK 49 million (-4).

CellaVision's sales have historically experienced seasonal variations. As a result of lower activity levels during vacation seasons, sales in the third quarter are generally subject to a slight decline. In the quarter, all geographic segments reported an increase in relation to relatively weak comparative figures.

In the Americas, sales grew by 51 percent to SEK 48 million (31), compared with the corresponding quarter in 2020, which was heavily impacted by the pandemic. Compared to the previous quarter, a slight seasonal decline was experienced. However, this pattern was much less accentuated than what has been seen in the past, indicating a continued underlying recovery, which was also confirmed by increased activity levels and physical product demonstrations to end-customers.

In APAC, sales grew by 14 percent in the quarter to SEK 18 million (16). While a temporary downturn was encountered in Japan as a result of the order timing in the second half of 2021, sales in the Chinese market has been stable. However, several historically smaller markets for CellaVision have shown strong improvement during the quarter.

In EMEA, sales grew by 63 percent in the quarter to SEK 66 million (40). Invoiced sales of reagents in the quarter received a boost by SEK 3 million rollover from the previous quarter, but even excluding this one-time effect, sales of reagents, especially hematology reagents, has shown substantial growth in the quarter as well as year to date.

Continued focus

As COVID-19 restrictions are lifted across countries, we are intensifying our activities to promote CellaVision® DC-1 in various geographies and in different types of hospital settings. We see opportunities of continued sales of the DC-1 to laboratories integrated in larger networks but also to stand-alone laboratories as the effects of the pandemic continue to subside.

CellaVision is actively working to create awareness and educate the market for the DC-1 through trade fairs and customer visits. With the product's value proposition including laboratory connectivity and our CellaVision® Remote Review Software, we see possibilities for a healthy growth journey to come. However, as for all the company's instruments the DC-1 has a long sales cycle. The process involves building product knowledge with distributors and laboratory personnel as well as timing the acceptance of the solution with budgeting processes at hospitals and laboratories before actual purchases can be realized.

When it comes to sales of our RAL reagents, we continue to see growth in Europe driven by increasing sales of hematology reagents through CellaVision's network of partners. As part of our strategy to expand sales of RAL's products internationally, we are currently investing in manufacturing capabilities at our plant in France to be able to meet increasing demands in the future. Our efforts to globalize this product offering are currently centered to Asia as we see opportunities to convert reagent consumption of local suppliers across the Asian market. In the Americas, we see opportunities to penetrate the market with our high-quality methanol-free RAL reagent (MCDh) which also offers unique environmental benefits.

Distributor partnerships

As communicated in our previous interim report, CellaVision has given notice of termination of the distribution agreement with Mindray Medical International Co., Ltd. The current agreement will be terminated by February 2022, since Mindray has launched their own Digital Cell Morphology (DCM) solution. CellaVision will continue to service our joint customer base that have CellaVision's solutions installed, and our commitment and strategic focus to lead Digital Cell Morphology and build long-term sustainable partnerships with our distribution partners remain intact.

CellaVision continues to monitor competitive offerings and study the successes and shortcomings of new entrants to Digital Cell Morphology. We are pleased to see more DCM solutions in the market that can aid in promoting the use of digital medical solutions for end users in all parts of the world.

Raw material supply

In the quarter, the global supply shortage of semiconductor chips also affected CellaVision. The supply chain disturbance was resolved quickly, and delivery capacity remained intact during the quarter. We continue to monitor the situation and we are working proactively to handle potential supply chain disturbances going forward. Throughout the quarter, we have validated second sourcing of certain key components and will continue to do so depending on the supply chain development.

Post-pandemic direction

As the effects of the pandemic are subsiding in large parts of the world, CellaVision is preparing to step up marketing and innovation ambitions even further. Accordingly, paused projects are reactivated and our geographical expansion plans are being resumed. We are also preparing to accelerate activities related to local market support within some of our existing markets, as well as preparing for recruitments to our operations in EMEA and the Americas.

Simultaneously, we are working to refine the company's strategic direction, to keep delivering high quality solutions and consumables that secure diagnostic certainty by leveraging and developing CellaVision's core capabilities. We intend to seize growth opportunities through accelerating our efforts in developing industry-leading DCM solutions for the benefit of patients, and laboratory personnel throughout the world. This direction is being operationalized in our plans for 2022 and will be executed upon as the world returns to a more normal situation.

Sales, earning and investments

Sales and exchange effects

Net sales for the Group's third quarter increased by 50 percent to SEK 132 million (88), compared to the corresponding period last year. CellaVision invoices most of the sales in Euros and US dollars, which means that exchange rate fluctuations have an impact on the company's sales and earnings. Adjusted for negative currency effects of 2 percent, sales organically increased by 52 percent compared to the corresponding period last year.

Net sales for the Group amounted to SEK 401 million (340) for the nine-month period. Adjusted for negative currency effects of 6 percent, sales organically increased by 24 percent compared to the corresponding period last year.

Gross profit and gross margin

Gross profit increased by 60 percent to SEK 91 million (57) in the third quarter, corresponding to a gross margin of 69 percent (65). The gross profit increased to SEK 278 million (227), corresponding to a gross margin of 69 percent (67) for the ninemonth period.

The gross margin is mainly affected by the product mix, depreciation of capitalized development expenses and currency effects.

Depreciation of capitalized development expenses decreased to SEK 2 million (3) in the third quarter and decreased to SEK 5 million (8) for the nine-month period. The lower depreciation is attributable to development projects that have been fully depreciated over the past twelve months.

Operating expenses

Operating expenses increased by 42 percent to SEK 57 million (40) during the third quarter. The difference between the current and previous year is mainly explained by low expenses in 2020 due to increased cost control related to the COVID-19 pandemic. Market conditions and sales have improved during the year, allowing CellaVision to resume activities that were postponed due to the pandemic. The most apparent acceleration of activities is seen within research and development which is in accordance with long term product development goals.

For the nine-month period the operating expenses increased by 12 percent to SEK 167 million (149).

Investments

The Group continuously capitalizes expenses for product development. Capitalized development costs increased during the quarter by 60 percent to SEK 9 million (5). The quarter's total research and development costs, before capitalization, amounted to SEK 26 million (16). Capitalized development costs increased for the nine-month period to SEK 27 million (18). The total research and development costs, before activation, amounted to SEK 74 million (57).

Most of the capitalized expenses are related to hardware and software application development.

EBITDA and EBITDA margin

EBITDA increased by 72 percent to SEK 42 million (25) in the third quarter, corresponding to an EBITDA margin of 32 percent (28). The improvement compared to last year is explained by

improved gross margin and CellaVision's scalable business model. The scalability implies that increased sales in combination with lean business operations generate an improved profit margin. For the nine-month period, EBITDA amounted to SEK 136 million (102), corresponding to an EBITDA margin of 34 percent (30).

Net financial items

The Group's interest-bearing liabilities in the form of bank loans amounted to SEK 97 million (122). Interest expenses from bank loans amounted to SEK 0.3 million (0.5). In addition to interest expense from bank loans, net financial income is attributable to foreign exchange gain/loss on acquisition loans included in Euro and interest on leasing liability in accordance with IFRS 16.

For the nine-month period, interest expense from bank loans decreased by 36 percent to SEK 0.9 million (1.4).

Cash flow

The Group's cash and cash equivalents at the end of the quarter amounted to SEK 112 million (95). The Group had a strong positive cash flow from operating activities which for the quarter amounted to SEK 49 million (-4).

The change in working capital amounts to SEK 7 million (-17) for the period and has been affected by a refunded deposit of SEK 16 million and increased capital tied-up in inventories of SEK 11 million. The refunded deposit was paid out last year, as part of

securing component supply. Increased inventory is related to last time buy of components.

The Group´s cash position allows us to terminate the factoring in RAL Diagnostics which has affected financing activities negatively by SEK 9 million. The Group's total cash flow for the quarter amounted to SEK 20 million (-21).

For the nine-month period cash flow from operating activities amounted to SEK 114 million (46) and total cash flow amounted to 9 million (-8). The cash position was reduced during this year by dividends to shareholders of SEK 18 million (0) and a selffinanced part of the acquisition of Clearbridge BioPhotonics of SEK 16 million (0).

Development in the geographical markets

Americas: SEK 48 million (31)

Sales increased by 51 percent in the Americas, to SEK 48 million (31) in relation to temporarily low comparable figures last year. While sales are not yet at pre-pandemic levels, steady recovery has been seen in the region over the previous quarters. Market conditions have improved in the U.S. and Canada which has implied increased access to laboratories during the quarter. As the pandemic subsides, the company's market support organizations have introduced a combination of virtual and physical product demonstrations. Towards the end of the quarter, CellaVision was able to attend the annual AACC meeting in Atlanta.

Large instruments continue to account for a substantial portion of CellaVision's sales and the company's solutions continue to deliver advantages for patients and laboratory personnel. Positive feedback from demonstrations has been received and interest for the DC-1 is seen. In Americas, initial installations have primarily been directed to satellite laboratories. While many market activities are ongoing, the processes prior to achieving sales transactions are long.

As for the methanol-free RAL reagent (MCDh), an initial review of the addressable market in the Americas suggests potential for delivering customer value, as this high-quality reagent has a far less negative effect on the environment compared to the industry's regular reagent offering. Application for market clearance of RAL MCDh has been submitted for FDA approval in the U.S.

APAC: SEK 18 million (16)

Sales in APAC increased by 14 percent to SEK 18 million (16) compared to last year's corresponding period, in which sales were adversely affected by the pandemic. APAC has been heavily affected by COVID-19 and new restrictions in some geographies have entailed a slower recovery in comparison to other regions. During the quarter, sales in China was stable, strong developments were seen in Hong Kong, Taiwan, and Thailand, whereas especially Japan had a weaker quarter as a result of postponed sales orders. However, there is a positive underlying trend in Japan partly driven by a mature replacement market.

For the DC-1, which has received sales clearance in all the company's Asian markets except China, education and demonstrations of the instrument continue together with CellaVision's distribution partners. Repetition of the electromagnetic

EMEA: SEK 66 million (40)

In EMEA, sales grew by 63 percent to SEK 66 million (40). Many countries in the region are alleviating COVID-19 restrictions but the speed with which societies are returning to a more normal situation differs. However, the general market conditions are close to pre-pandemic levels which has further increased the possibilities of physical demonstrations of the company's solutions.

Sales of CellaVision's large systems in regional key markets continued to perform well during the quarter and traction for the company's large instruments is seen throughout the region. Progress is also seen in key markets throughout EMEA for the company's smaller instrument. The region accounts for 50 percent of the company's total DC-1 sales.

Reagent sales in the quarter had a positive rollover effect of SEK 3 million from the second quarter. Additionally, sales in the company's more mature markets such as Germany, the UK and Spain continued at full speed. Demand for RAL reagents is also growing in smaller countries and CellaVision plans on introducing the product line to more countries throughout EMEA. The RAL reagent offering consists of both reagents applicable for hematology and reagents applicable for other adjacent areas. Sales of hematology reagents showed 18 percent growth in local currency year to date, while sales of reagents for adjacent areas showed single digit growth. The RAL MCDh reagent is undergoing testing by key distribution partners in the region.

Innovation

Improving healthcare through continuous innovation is one of CellaVision's fundamental ambitions. CellaVision devotes considerable resources to being at the forefront of innovation. The company's focus is innovation of applied research and development that meets customer needs, serves laboratory personnel and improves laboratory workflows.

CellaVision conducts profound feasibility testing and development work to increase current and future product offerings to remain the market leader within Digital Cell Morphology in hematology.

Resources from research and development have in the quarter been assigned to contribute to mitigate the effects of the global component shortage through validating second sourcing of key components. Nevertheless, the impact on other projects has

been limited and the issues have been resolved without delivery disruptions.

CellaVision recently acquired a patent portfolio containing the new microscopy technology Fourier ptychography microscopy. The technology is a method for creating high-magnification images with low-magnification optics, which enables large image areas to be collected with high resolution and higher speed than with conventional digital microscopy.

Fourier ptychography microscopy may be used to develop future automated microscopes with applications in hematology and adjacent areas. The long-term research effort to further develop and adapt the technology to CellaVision's needs continues.

During the quarter, the company was granted three new patents on a previously patented focus algorithm. Using the algorithm, the distance to perfect focus can be calculated from a single image, which enables faster focus than conventional methods. Patents have now been granted in the UK, France and Germany.

CellaVision's patent portfolio at the end of the period, grants rights to 25 patented inventions and 109 granted patents.

The Nomination Committee and the Annual General Meeting in 2022

The Nomination Committee for the Annual General Meeting in 2022

In accordance with a resolution of the 2021 Annual General Meeting, the Nomination Committee shall consist of representatives of each of the four largest shareholders in terms of voting rights at the end of July 2021. The Chairman of the Board, Mikael Worning, convenes the Nomination Committee and may participate in the work as an adjunct.

Ahead of the Annual General Meeting in 2022, the Nomination Committee consists of: Christer Fåhraeus, (appointed by Christer Fåhraeus with Companies) Nicklas Hansen (appointed by William Demant Invest A / S), Daniel Klint (appointed by SEB Investment funds) and Emil Hjalmarsson

(appointed by Grenlunden CEVI AB). Christer Fåhraeus has been appointed chairman of the Nomination Committee.

The Nomination Committee of CellaVision has been convened in accordance with the guidelines adopted at the Annual General Meeting 2021.

Shareholders wishing to submit proposals to the Nomination Committee can send an email to [email protected], or ordinary mail to: The Nomination Committee, CellaVision AB, Mobilvägen 12, 223 62 Lund.

Annual General Meeting 2022

CellaVision's Annual General Meeting in 2022 will be held in Lund at 15:00 o´clock CEST, on May 11, 2022. Shareholders wishing to have matters considered at the Annual General Meeting can send a written request by email to: [email protected], or ordinary mail addressed to: The Board of Directors, CellaVision AB, Mobilvägen 12, 223 62 Lund.

The request must have been received at the latest seven weeks before the Annual General Meeting in order to be included in the notice to attend and thus the agenda of the Annual General Meeting.

Declaration by the Board of Directors and President/CEO

The Board of Directors and the President/Chief Executive Officer certify that the interim report provides a true and fair view of the parent company´s and the Group´s business, financial position, performance and describes material risks and uncertainties, to which the parent company and the companies in the group are exposed.

Lund, October 22, 2021

Mikael Worning Christer Fåhraeus Åsa Hedin Gunnar B. Hansen

Member of the Board Member of the Board Member of the Board Member of the Board

Stefan Wolf Simon Østergaard Member of the Board President/CEO

Chairman of the Board Member of the Board Member of the Board Member of the Board Employee representative

Anna Malm Bernsten Niklas Prager Jürgen Riedl Markus Jonasson Kristoffersson Employee representative

The Interim report has been subject to review by the company's auditors.

Consolidated income statement in summary

Amounts in ' 000 SEK Jul-Sep 2021 Jul-Sep 2020 Jan-Sep 2021 Jan-Sep 2020 Jan-Dec 2020
Net sales 131,986 87,977 401,392 340,453 471,443
Cost of goods sold -40,716 -30,952 -123,565 -113,248 -158,402
Gross profit 91,271 57,025 277,827 227,205 313,041
Sales and marketing expenses -24,873 -19,973 -73,939 -73,489 -100,549
Administration expenses -15,339 -9,955 -45,206 -37,075 -50,966
R&D expenses -17,184 -10,488 -47,711 -38,239 -51,253
Operating profit 33,875 16,610 110,971 78,402 110,273
Interest income and financial exchange rate gains 327 3,302 2,073 11,082 7,118
Interest expense and financial exchange rate losses -1,476 -3,966 -5,787 -13,695 -5,163
Profit/loss before tax 32,725 15,946 107,256 75,789 112,228
Tax -6,630 -2,598 -21,672 -14,912 -22,748
Profit/loss for the period 26,095 13,348 85,584 60,877 89,480
Components not to be reclassified to net profit:
Effect on revaluation of pensions
Tax effect on revaluation of pensions
-30
8
-20
6
-65
18
-36
10
-171
48
Sum of Components not to be reclassified to net profit: -22 -15 -47 -26 -123
Components to be reclassified to net profit:
a) Financial assets at fair value
Reclassified to operating result
0 367 -1,388 3,221 4,034
Revaluation of financial assets 0 439 0 149 1,193
Income tax relating to financial assets 0 -172 286 -721 -1,117
b) Translation difference
Translation difference in the group 2,548 764 4,321 1,564 -12,223
Sum of Components to be reclassified to net profit: 2,548 1,397 3,219 4,213 -8,112
Sum of other comprehensive income: 2,526 1,383 3,172 4,187 -8,236
Comprehensive result for the period 28,621 14,731 88,756 65,064 81,244

Per share data

Per share data Jul-Sep 2021 Jul-Sep 2020 Jan-Sep 2021 Jan-Sep 2020 Jan-Dec 2020
Earnings per share, before and after dilution, SEK */ 1.09 0.56 3.59 2.55 3.75
Equity per share, SEK 20.98 17.33 20.98 17.33 18.01
Number of shares outstanding 23,851,547 23,851,547 23,851,547 23,851,547 23,851,547
Average number of shares outstanding 23,851,547 23,851,547 23,851,547 23,851,547 23,851,547
Stock exchange rate, SEK 391.40 359.20 391.40 359.20 312.40
Dividend per share, SEK 0.00 0.00 0.75 0.00 0.00

*/ Based on the profit/loss for the period divided by the average number of shares in issue

Quarterly earnings trend

Amounts in ' 000 SEK Q3 2021 Q2 2021 Q1 2021 Q4 2020 Q3 2020 Q2 2020
Net sales 131,986 135,451 133,954 130,990 87,977 118,046
Gross profit 91,271 93,572 92,985 85,836 57,025 77,870
Gross margin in % 69 69 69 66 65 66
Expenses -57,396 -54,884 -54,575 -53,965 -40,415 -49,591
EBITDA 42,383 47,108 46,193 40,805 24,648 36,221
Net profit 26,095 31,000 28,490 28,603 13,348 27,252
Cash flow 20,045 -20,330 8,807 9,242 -21,184 18,097

Consolidated balance sheet in summary

Amounts in ' 000 SEK 09/30/2021 09/30/2020 06/30/2021 12/31/2020
Assets
Intangible assets 349,185 306,037 342,776 300,883
Tangible assets 46,726 49,260 47,968 47,428
Deferred tax assets 0 0 0 0
Financial assets 21,885 22,542 21,818 21,648
Inventory 102,840 85,565 91,724 83,660
Trade receivables 78,650 64,907 76,003 71,030
Other receivables 36,159 42,921 54,669 41,114
Cash and bank 111,538 95,357 91,271 102,262
Total assets 746,983 666,587 726,228 668,025
Equity and liabilities
Equity 500,484 413,437 471,863 429,617
Deferred tax liability 46,220 41,473 45,253 43,377
Other provisions 4,170 3,505 4,081 3,982
Long-term debt, interest-bearing 75,462 98,849 83,528 86,904
Short-term debt, interest-bearing 38,609 47,333 48,121 45,874
Short-term debt, non interest-bearing 49,562 38,772 43,178 35,531
Trade payables 30,159 21,232 28,149 20,865
Warranty provisions 2,318 1,988 2,055 1,875
Total equity and liabilities 746,983 666,587 726,228 668,025

Consolidated statement of changes in equity

Amounts in ' 000 SEK 09/30/2021 09/30/2020 06/30/2021 12/31/2020
Balance at the beginning of the year 429,617 348,373 429,617 348,373
Dividend -17,889 0 -17,889 0
Net profit for the year 85,584 60,877 59,490 89,480
Comprehensive result for the period 3,172 4,187 645 -8,236
Balance at the end of the year 500,484 413,437 471,863 429,617

Cash flow analysis in summary

Amounts in ' 000 SEK Jul-Sep 2021 Jul-Sep 2020 Jan-Sep 2021 Jan-Sep 2020 Jan-Dec 2020
Result before taxes 32,725 15,946 107,256 75,789 112,228
Adjustment for items not included in cash flow 15,528 241 34,282 11,447 15,630
Taxes -6,135 -2,704 -18,993 -13,027 -20,931
Cash flow from operations before changes in working capital 42,119 13,483 122,546 74,208 106,926
Changes in working capital 6,632 -17,424 -8,688 -28,657 -35,802
Cash flow from operations 48,751 -3,941 113,858 45,551 71,124
Acquisitions 0 0 0 -1,269 -1,269
Capitalization of development costs -8,791 -5,486 -26,597 -18,404 -25,524
Acquisitions of intangible non-current assets -39 -23 -31,802 -64 -64
Acquisitions of financial non-current assets 64 -4 44 -62 -33
Acquisitions of tangible non-current assets -1,486 -1,078 -8,514 -4,987 -8,069
Cash flow from investment activities -10,253 -6,591 -66,870 -24,786 -34,959
Acquired loans 1,175 220 20,705 2,047 3,041
Amortization of loans -16,975 -8,484 -33,305 -24,136 -28,721
Amortization of leasing debts -2,652 -2,388 -7,978 -6,971 -9,537
Dividend 0 0 -17,889 0 0
Cash flow from financing activities -18,452 -10,652 -38,467 -29,060 -35,218
Total cash flow 20,045 -21,184 8,520 -8,295 948
Liquid funds at beginning of period 91,271 115,492 102,262 102,312 102,312
Exchange rate fluctuations in liquid funds 222 1,048 756 1,339 -998
Liquid funds at end of period 111,538 95,357 111,538 95,357 102,262

Disclosures regarding interest expense:

Interest expenses for Jan-Sep amount to SEK 1,324 thousand whereof SEK 424 thousand is attributable to leasing in accordance with IFRS 16.

Income statement - parent company

Amounts in ' 000 SEK Jul-Sep 2021 Jul-Sep 2020 Jan-Sep 2021 Jan-Sep 2020 Jan-Dec 2020
Net sales 104,308 67,630 322,842 267,140 372,387
Cost of goods sold -25,181 -15,668 -75,876 -64,199 -90,677
Gross profit 79,126 51,962 246,966 202,941 281,711
Sales and marketing expenses -19,312 -16,478 -57,797 -60,066 -78,528
Administration expenses -12,429 -8,137 -36,609 -29,092 -40,846
R&D expenses -24,261 -15,196 -69,085 -53,672 -72,057
Operating profit 23,124 12,150 83,475 60,112 90,279
Interest income and financial exchange gains 326 3,114 2,027 10,686 13,185
Interest expense and financial exchange losses -1,171 -3,446 -4,785 -12,392 -3,406
Profit before income tax 22,279 11,818 80,717 58,405 100,058
Taxes -4,589 -2,529 -16,828 -12,499 -20,097
Net profit 17,690 9,289 63,889 45,907 79,962
Comprehensive profit for the period 17,690 9,289 63,889 45,907 79,962
Sum of other comprehensive income 0 0
0 0 0
Other comprehensive income 0 0 0 0 0
Net profit for the period 17,690 9,289 63,889 45,907 79,962
Statement of Comprehensive Income

Balance sheet - parent company

Amounts in ' 000 SEK 09/30/2021 09/30/2020 06/30/2021 12/31/2020
Assets
Intangible assets 5,438 6,138 5,579 5,707
Tangible assets 4,234 5,493 4,805 5,138
Deferred tax assets 668 3,678 668 668
Financial assets 282,309 263,014 282,309 263,014
Inventory 70,458 52,092 63,102 56,009
Trade receivables 58,091 45,573 58,637 55,176
Receivables from group companies 15,977 4,516 15,130 3,525
Other receivables 34,410 41,549 51,997 40,383
Cash and bank 97,133 69,038 68,278 72,958
Total assets 568,718 491,091 550,505 502,578
Equity and liabilities
Equity 406,478 326,423 388,788 360,477
Other provisions 123 0 65 0
Long-term debt, interest-bearing 57,767 72,100 63,941 62,935
Short-term debt, interest-bearing 26,258 24,033 26,085 22,886
Short-term debt, non interest-bearing 36,558 27,354 30,614 26,070
Trade payables 22,473 18,066 21,571 16,075
Liabilities to group companies 16,744 21,128 17,387 12,260
Warranty provisions 2,318 1,988 2,055 1,875
Total equity and liabilities 568,718 491,091 550,505 502,578

Notes

NOTE 1. ACCOUNTING POLICIES

The Group applies International Financial Reporting Standards (IFRS), as adopted by the EU. This interim report has been prepared in accordance with IAS 34 Interim Financial Reporting, the Annual Accounts Act and the Nasdaq Stockholm Rule Book for Issuers. Disclosures in accordance with IAS 34 p. 16A appear not only in the financial statements and their accompanying notes but

NOTE 2. SEGMENT REPORTING

CellaVision's operations only comprise one operating segment; automated microscopy systems in the field of hematology, and therefore reference is made to the income statement and balance sheet regarding operating segment reporting.

also in other parts of the interim report. The parent company applies the Annual Accounts Act and the Swedish Financial Reporting Board recommendation RFR 2 Accounting for Legal Entities. The accounting policies and calculation methods applied are consistent with those described in the annual report for 2020.

NOTE 3. RISKS AND UNCERTAINTIES

Reduced demand, currency fluctuations and production disruptions are uncertainties but not material risks. However, as earlier mentioned, this may be affected by COVID-19. For a more detailed description of the risks and uncertainties facing CellaVision, please refer to the risk analysis and Note A2 and A5 in the 2020 Annual and Sustainability Report.

NOTE 4. ALLOCATION OF SALES

Amounts in ' 000 SEK Jul-Sep 2021 Jul-Sep 2020
Instruments Reagents Other Total Instruments Reagents Other Total
Americas 29,138 644 17,769 47,551 16,862 332 14,278 31,472
APAC 15,457 396 2,629 18,481 14,198 368 1,577 16,143
EMEA 29,804 23,196 12,953 65,954 15,847 16,609 7,905 40,361
Total 74,399 24,236 33,351 131,986 46,907 17,309 23,760 87,977
Jan-Sep 2021 Jan-Sep 2020
Amounts in ' 000 SEK Instruments Reagents Other Total Instruments Reagents Other Total
Americas 76,019 1,258 59,774 137,050 66,285 1,534 46,490 114,309
APAC 60,820 1,601 10,074 72,496 66,303 1,051 7,062 74,416
EMEA 89,400 64,704 37,742 191,846 63,349 59,456 28,923 151,728
Total 226,239 67,563 107,590 401,392 195,937 62,041 82,475 340,453

Other refers to software, spare parts and consumables.

NOTE 5. FINANCIAL INSTRUMENTS

09/30/2021 09/30/2020
Reported value Fair value Reported value Fair value
0 0 266 266
0 0 -726 -726

Derivative assets are included in other current recivables in the statement of financial position and derivative liabilities are included in short-term debt. The derivatives refer to forward exchange contracts held for currency hedging.

The forward exchange contracts are valued in level 2 of the valuation hierarchy, financial instruments where fair value is determined based on valuation model based on other observable data for the asset or liability than quoted prices included in level 1, either directly (ie as price quotes) or indirectly (ie derived from price quotaions). The currency forwards are valued on the basis of observable information regarding exchange rates prevailing on the balance sheet date and market interest rates for the remaning maturity.

For other financial assets and liabilities, the carrying amount is considered a reasonable approximation of fair value.

NOTE 6. TANGIBLE FIXED ASSETS

Amounts in ' 000 SEK 09/30/2021 09/30/2020
Right of use assets
Land and buildings 15,334 22,091
Inventories 3,030 2,260
Total right of use assets 18,364 24,351
Tangible fixed assets that are not right of use assets
Land and buildings 15,127 14,488
Inventories 13,235 10,421
Total tangible fixed assets that are not right of use assets 28,362 24,909
Total tangible fixed assets 46,726 49,260

The tangible fixed assets amounted to SEK 47 milion on the balance sheet date. The majority of the right of use assets consists of leases for office premises. For all leases for which the Group is lessee (which are not short term leases or low value assets), the Group recognizes a right of use asset and a corresponding lease liability.

When valuating the right of use asset, the acquisition method is used, i.e the right of use asset is calculated at acquisition cost, adjusted for any revaluation of the lease liability less depreciation.

The right of use asset is reported as a tangible fixed asset, while leasing liability is reported separately in the Group's statement of financial position as long-term debt, interest-bearing and short-term debt, interest-bearing.

NOTE 7. EMPLOYEES

09/30/2021 09/30/2020
Number of employees 201 180
Of which men 117 110
Of which women 84 70

The note refers to number of employees in the Group converted into full-time positions.

NOTE 8. SIGNIFICANT EVENTS AFTER THE PERIOD CLOSE

No significant events have occurred after the period close.

Reconciliation tables KPIs, non-IFRS measures

The company presents certain financial measures in the interim report which are not defined according to IFRS. The company considers these measures to provide valuable supplementary information for investors and the company's management as they enable the assessment of relevant trends. CellaVision's definitions of these measures may differ from other companies' definitions of the same terms. These financial measures should therefore be seen as a supplement rather than as a replacement for measures defined according to IFRS. Definitions of measures which are not defined according to IFRS and which are not mentioned elsewhere in the interim report are presented below. Reconciliation of these measures is shown in the tables below.

Key performance indicators not defined according to IFRS

Currency effect. Exchange rate effects on sales growth for the period.

Equity/assets ratio. Shareholders' equity including noncontrolling interests as a percentage of total assets. Gross margin. Gross profit as a percentage of net sales. Gross profit. Net sales less cost of goods sold. Shareholders' equity per share. Shareholders' equity attributa-

ble to Parent Company shareholders divided by the number of outstanding shares at the end of the period.

Operating margin (EBIT), %. Operating profit (EBIT) as a percentage of net sales for the period. Operating profit (EBIT). Earnings before interest and tax

Net earnings per share

Jul-Sep 2021 Jul-Sep 2020 Jan-Sep 2021 Jan-Sep 2020 Jan-Dec 2020
Profit/loss for the period, KSEK 26,095 13,348 85,584 60,877 89,480
Number of shares 23,851,547 23,851,547 23,851,547 23,851,547 23,851,547
Net earnings per share 1.09 0.56 3.59 2.55 3.75

Equity per share

Jul-Sep 2021 Jul-Sep 2020 Jan-Sep 2021 Jan-Sep 2020 Jan-Dec 2020
Equity, KSEK 500,484 413,437 500,484 413,437 429,617
Number of shares 23,851,547 23,851,547 23,851,547 23,851,547 23,851,547
Equity per share 20.98 17.33 20.98 17.33 18.01

Equity-asset ratio

KSEK Jul-Sep 2021 Jul-Sep 2020 Jan-Sep 2021 Jan-Sep 2020 Jan-Dec 2020
Equity 500,484 413,437 500,484 413,437 429,617
Balance sheet total 746,983 666,587 746,983 666,587 668,025
Equity ratio 67% 62% 67% 62% 64%

Gross margin

KSEK Jul-Sep 2021 Jul-Sep 2020 Jan-Sep 2021 Jan-Sep 2020 Jan-Dec 2020
Net sales 131,986 87,977 401,392 340,453 471,443
Gross profit 91,271 57,025 277,827 227,205 313,041
Gross margin 69% 65% 69% 67% 66%

Reconciliation tables KPIs, non-IFRS measures, cont'd

Operating margin

KSEK Jul-Sep 2021 Jul-Sep 2020 Jan-Sep 2021 Jan-Sep 2020 Jan-Dec 2020
Net sales 131,986 87,977 401,392 340,453 471,443
Operating profit 33,875 16,610 110,971 78,402 110,273
Operating margin 26% 19% 28% 23% 23%

EBITDA

KSEK Jul-Sep 2021 Jul-Sep 2020 Jan-Sep 2021 Jan-Sep 2020 Jan-Dec 2020
Operating profit 33,875 16,610 110,971 78,402 110,273
Depreciation 8,508 8,039 24,712 23,688 32,622
EBITDA 42,383 24,649 135,683 102,090 142,895

Net sales

Jul-Sep 2021 Jul-Sep 2020
Jul-Sep 2021 (%) KSEK Jul-Sep 2020 (%) KSEK
Last period 87,977 95,599
Organic growth 51.9% 46,492 -24% -22,588
Currency effect -1.9% -2,590 -5% -4,569
Structural growth 0.1% 107 21% 19,535
Current period 50.1% 131,986 -8% 87,977

Review Report

To the Board of Directors and the President of CellaVision AB Corporate identity number 556500-0998

Introduction

We have performed a review of the interim report for CellaVision AB (publ.) as per September 30, 2021 and the nine-month period ending on that date. The Board of Directors and the President are responsible for preparing and presenting this interim report in accordance with IAS 34 and the Annual Accounts Act. Our responsibility is to express a conclusion on this interim report based on our review.

Scope of the Review

We conducted our review in accordance with the Standard on Review Engagements 2410 "Review of Interim Financial Information Performed by the Independent Auditor of the Entity". A review consists of making inquiries, primarily of persons responsible for financial and accounting matters, and applying analytical and other review procedures. A review has a different focus and is substantially less in scope than an audit conducted in accordance with ISA and other generally accepted auditing practices.

The procedures performed in a review do not enable us to obtain a level of assurance that would make us aware of all significant matters that might be identified in an audit. Therefore, the conclusion expressed on the basis of a review does not give the same level of assurance as a conclusion expressed on an audit.

Conclusion

Based on our review, nothing has come to our attention that causes us to believe that the interim report does not, in all material respects, prepared for the Group in accordance with IAS 34 and the Annual Accounts Act, and for the Parent Company, with the Annual Accounts Act.

Lund, October 22, 2021

Deloitte AB

Jeanette Roosberg Authorized Public Accountant

This is CellaVision

Vision

CellaVision's vision is to replace traditional microscopes in laboratories through global digitalization and automation of blood analysis for both the human and veterinary segments. The company's solutions contributes to improved patient diagnostics, higher efficiency and reduced healthcare costs.

CellaVision delivers unique solutions for Digital Cell Morphology (DCM)

CellaVision offers products and solutions to hematology laboratories that enable an efficient process for routine analysis of blood. The product offer consists of stains, blood smearing and staining devices, analyzers, applications and software. The solutions from CellaVision enable laboratories to automate, standardize and digitalize their workflow.

Blood analysis plays an important and vital role in offering high-quality healthcare. Complete blood count is one of the world's most common diagnostic tests and is routinely used to obtain an overall status of the blood cells. The driving force and objective for CellaVision is to equip laboratory staff with the best tools and solutions available on the market to handle differential blood counts of blood cells.

Offer to end customers

CellaVision offers products for sample preparation and digital solutions for medical microscopy in hematology. The end customers are hospital laboratories and commercial laboratories. CellaVision's unique concept replaces manual microscopes and improves the blood analysis process. In this way more patients can receive faster care of better quality while healthcare services can use their resources better.

Strategic partnerships and distribution via suppliers of cell counters

CellaVision collaborates with strategic partners in order to gain scalability in manufacturing and sales. CellaVision's solutions are the last step in a blood analysis process, in which the cell counter is central. Agreements with the foremost suppliers of cell counters are therefore strategically important so as to reach end customers in a cost effective way. CellaVision's partners have a broad range of products and global salesforces with local knowledge. CellaVision's own organization supports its partners in the sales process.

Financial targets

CellaVision's objective is to create a global standard for digital microscopy in the sub-field hematology. The objective is broken down into important financial targets.

• Sales growth

Increase sales over an economic cycle by an average of at least 15 percent per year.

• Profitability

The operating margin iwws to exceed 20 percent over an economic cycle.

Questions concerning the report can be addressed to:

Simon Østergaard, President & CEO Tel: +46 46 460 16 23 [email protected]

Magnus Blixt, CFO Tel: +46 46 460 16 46 [email protected]

Publication

This information constitutes information that CellaVision AB (publ) is obliged to make public pursuant to the EU Market Abuse Regulation. The information was submitted for publication at 7:20 a.m. CEST on October 22, 2021.

CellaVision is listed on the Nasdaq Stockholm , Mid Cap list. The company is traded under the ticker symbol CEVI and ISIN code SE0000683484.

Conference

In connection with the release of the interim report analysts, investors and media are invited to a telephone conference and audio webcast at 11:00 CEST where Simon Østergaard, President & CEO, will present and comment the report. The presentation will be in English via a conference call or audio webcast: https://tv.streamfabriken.com/cellavision-q3-2021

Phone number for the conference: SE: +46 8 51 999 383 UK: +44 33 33 009 268 US: +1 63 19 131 422

No pre-registration is required. Please dial in 5-10 minutes prior to the scheduled start time to facilitate a timely start.

Financial calendar

Activity Date
Year-end bulletin 2021 February 4, 2022
Interim Report January-March May 10, 2022
Annual General Meeting May 11, 2022
Interim Report January-June 20 July, 2022
Interim Report January-September 26 October, 2022
Year-end bulletin 2022 7 February, 2023

NOTE: This is an unofficial translation of the original Swedish Interim Report. In case of discrepancies, the Swedish version shall prevail.

CellaVision in the world

HEAD QUARTERS SWEDEN

CellaVision AB (publ) Mobilvägen 12 SE-22362 Lund, Sweden Established 1998

Visiting address: Mobilvägen 12 Phone: +46 46 460 16 00 www.cellavision.se Org. Reg. No. 556500-0998

USA

CellaVision Inc. 2530 Meridian Pkwy, Suite 300 Durham, NC 27713 E-mail [email protected] Established 2001

CANADA

CellaVision Canada Inc. 2 Bloor St West, Suite 2120 Toronto, ON M4W 3E2 E-mail [email protected] Established 2007

JAPAN

CellaVision Japan K.K. 9th Floor Sotestu KS Building 1-1-5 Kitasaiwai,Nishi-ku, Kanagawa 220-0004 Japan Email: [email protected] Established 2008

CHINA

Shanghai (Market Support office) Email: [email protected] Established 2012

Beijing (Market Support office) Email: [email protected] Established 2013

SOUTH KOREA

Seoul (Market Support office) Email: [email protected] Established 2016

MIDDLE EAST

Dubai (Market Support office) Email: [email protected] Established 2016

AUSTRALIA

Sydney (Market Support office) Email: [email protected] Established 2016

FRANCE

Paris (Market Support office) Email: [email protected] Established 2016

GERMANY

Berlin (Market Support office) Email: [email protected] Established 2017

BRAZIL

São Paulo (Market Support office) Email: [email protected] Established 2017

UK

London (Market Support office) Email: [email protected] Established 2017

MEXICO

Mexico City (Market Support office) Email: [email protected] Established 2018

INDIA

Mumbai (Market Support office) Email: [email protected] Established 2018

THAILAND

Bangkok (Market Support office) Email: [email protected] Established 2018

ITALY

Naples (Market Support office) Email: [email protected] Established 2019

IBERIA

Madrid (Market Support office) Email: [email protected] Established 2019

RUSSIA

Moscow (Market Support office) Email: [email protected] Established 2020

With 18 organizations for local market support CellaVision has direct presence in more than 40 countries.