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CellaVision Interim / Quarterly Report 2021

Jul 20, 2021

3025_ir_2021-07-20_a8201085-9ef1-47d9-bb5a-72bb324b3bdb.pdf

Interim / Quarterly Report

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CellaVision Interim report Q2 January - June 2021

Increasing activity levels and double-digit growth with maintained strong profitability

Organic sales growth: Q2, 2021: +23% (-15)

EBITDA margin: Q2, 2021: 35% (31)

"We are ramping up market activities, continuing reagent expansion in APAC and executing strategic investments in our innovation pipeline, while reaching our highest profit ever."

Simon Østergaard President and CEO

Apr-Jun Jan-Jun
(MSEK) 2021 2020 2021 2020 2020
Net sales 135.5 118.0 269.4 252.5 471.4
Gross profit 93.6 77.9 186.6 170.2 313.0
EBITDA 47.1 36.2 93.3 77.4 142.9
EBITDA margin, % 35 31 35 31 30
Profit/loss before tax 38.9 34.4 74.5 59.8 112.2
Total cash flow -20.3 18.1 -11.5 12.9 0.9
Equity ratio, % 65 60 65 60 64

1 April-30 June 2021

  • Net sales increased by 15% to SEK 135.5 million (118.0).
  • Sales increased organically by 23% (-15), currency effect -8%.
  • EBITDA amounted to SEK 47.1 million (36.2).
  • EBITDA margin amounted to 35% (31).
  • Profit before tax amounted to SEK 38.9 million (34.4).
  • Earnings per share before and after dilution were SEK 1.30 (1.14).
  • Cash flow from operating activities amounted to SEK 38.9 million (34.1).

1 January-30 June 2021

  • Net sales increased by 7% to SEK 269.4 million (252.5).
  • Sales increased organically by 16% (-8), currency effect -7%.
  • EBITDA amounted to SEK 93.3 million (77.4).
  • EBITDA margin amounted to 35% (31).
  • Profit before tax amounted to SEK 74.5 million (59.8).
  • Earnings per share before and after dilution were SEK 2.49 (1.99).
  • Cash flow from operating activities amounted to SEK 65.1 million (49.5).

Significant events during the period

• CellaVision acquired the exclusive rights to a patent portfolio containing a new microscopy technology, Fourier Ptychographic Microscopy, from Clearbridge BioPhotonics. The acquisition gives CellaVision access to and control over an interesting future technology. The total acquisition expense amounted to SEK 31.4 million.

Significant events after the period close

• CellaVision has given notice of termination of the distribution agreement with Mindray Medical International Co., Ltd. The agreement signed in 2018 will be terminated by February 2022.

CEO's comment

The effects of the COVID-19 pandemic continued to diminish during the quarter with turnover and results in line with our plans. We are ramping up market activities as laboratory interactions have been enabled across countries in Europe and North America. While a gradual normalization is seen in the markets, CellaVision has continued its work with its strategic plan to secure CellaVision's position as the global market leader within Digital Cell Morphology (DCM) today as well as long-term.

The second quarter in brief

Sales for the Group amounted to SEK 135.5 million (118.0), representing an organic growth of 23 percent, equivalent to a growth of 15% after adjusting for a negative currency impact. In Americas, market conditions improved substantially as the U.S and Canada are returning to a more normal situation. Sales in the region grew by 66 percent compared with the corresponding quarter in 2020, which was heavily impacted by the pandemic. Europe was on par with the second quarter in 2020 with sales of SEK 57.8 million (56.6). In this region, the COVID-19 situation has improved substantially during the quarter, but market conditions are still not yet fully normal with variability across countries. In APAC, many countries maintain varying degree of restrictions, which has hampered our market activities in the region, and sales declined by 8 percent.

The quarter presented the highest EBITDA in CellaVision's history, which amounted to SEK 47.1 million (36.2), corresponding to an EBITDA margin of 35 percent (31). The Group's total cash flow for the quarter amounted to SEK -20.3 million (18.1) as a result of dividend payout and investment in patent rights while maintaining a strong operating cashflow of SEK 38.9 million (34.1).

Continued focus

As the effects of the pandemic are now subsiding in large parts of the world, CellaVision is preparing to step up marketing and innovation ambitions even further. We will resume our geographical expansion and enter new markets when the conditions seem appropriate. We will also accelerate activities related to local market support within some of our existing markets.

As COVID-19 restrictions ceases across countries, we are intensifying our activities to promote CellaVision® DC-1 in various geographies and in different types of hospital settings. We expect to see continued sales of the DC-1 to standalone laboratories across Europe but also to laboratories taking part in larger networks. The latter is expected to become a dominant target segment for DC-1 adoption throughout the American market. This allows for leveraging the product's value proposition to its full potential with laboratory connectivity and our CellaVision® Remote Review Software.

When it comes to RALs hardware and reagents, we are continuing our efforts to globalize this offering to provide customers worldwide with a state-of-the art solution for the entire digital morphology process. Work to leverage and demonstrate the value of using superior reagents and associated protocols is also progressing. We are progressing to demonstrate the value of RAL reagents with our priorities centered across China and the Asian countries. Ongoing evaluations of the reagent portfolio is progressing, which is expected to expand RAL reagent consumption by taking share from local competition.

Partnerships and acquisition

Our commitment and strategic focus to lead Digital Cell Morphology and build long-term sustainable partnerships with our distribution partners remain intact. Nonetheless, after the end of the quarter we have given notice of termination to Mindray Medical International Co Ltd. who has been a distribution partner in China. An agreement was formed in February 2018 and will now be terminated by February 2022. The termination of this agreement is expected to have limited effect for CellaVision. We will continue to service our joint customer base that have CellaVision's solutions installed.

Throughout the pandemic, CellaVision has continued to invest in innovation. During the second quarter, we acquired the exclusive rights to a patent portfolio containing a new microscopy technology, Fourier Ptychographic Microscopy, from Clearbridge BioPhotonics. The acquisition gives us access to and control over an interesting future technology. We believe it might enable

us to retrieve large quantities of information from images with considerable speed, which forms the basis for improved clinical laboratory analysis and workflow enhancements. The feasibility testing of the underlying technology has begun, and we are optimistic and excited to exploit future applications of this technology.

New ways of working

By the end of my first quarter with CellaVision I find it appropriate to express my sincere appreciation to the entire team and the board of directors including our new Chairman Mikael Worning. Collectively, we have continued the work with a methodical strategy process. The aim is to refine our strategic direction to keep delivering superior laboratory solutions and consumables that secure diagnostic certainty by leveraging and developing the core capabilities of CellaVision.

Simon Østergaard, President and CEO

Sales, earning and investments

Sales and exchange effects

Net sales for the Group's second quarter increased by 15 percent compared to the corresponding period last year, SEK 135.5 million (118.0). 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 8 percent, sales organically increased by 23 percent compared to the corresponding quarter of 2020.

Net sales for the Group amounted to SEK 269.4 million (252.5) for the six-month period. Adjusted for negative currency effects of 8 percent, sales organically increased by 15 percent compared to the corresponding period in 2020.

Gross profit and gross margin

Gross profit increased by 20 percent to SEK 93.6 million (77.9) in the second quarter, corresponding to a gross margin of 69 percent (66). For the six-month period the gross profit increased to SEK 186.6 million (170.2), corresponding to a gross margin of 69 percent (67).

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 1.6 million (2.7) in the second quarter and decreased to SEK 3.6 million (5.3) for the six-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 11 percent to SEK 54.9 million (49.6) during the second quarter. The difference between the current and previous year is mainly explained by low expenses last year due to increased cost control related to the COVID-19 pandemic. During the second quarter of the year, market conditions and sales have improved, allowing CellaVision to resume activities that were postponed during the pandemic. The most apparent acceleration of activities is seen within research and development in accordance with long term product development goals.

For the six-month period the operating expenses increased by 1 percent to SEK 109.5 million (108.4).

Investments

The Group continuously capitalizes expenses for product development. Capitalized development costs increased during the quarter by 42 percent to SEK 9.3 million (6.6). The quarter's total research and development costs, before capitalization, amounted to SEK 24.4 million (19.5). Capitalized development costs increased for the six-month period to SEK 17.8 million (12.9). The total research and development costs, before activation, amounted to SEK 48.3 million (40.7).

Most of the capitalized expenses are related to application development but also clinical trials that form the basis for registration of CellaVision® DC-1 in China.

In the second quarter of the year, CellaVision acquired all shares in Clearbridge BioPhotonics Pte Ltd in Singapore. The acquisition gives CellaVision exclusive rights to a patent portfolio containing a new microscopy technology. The acquisition is to

be viewed as an asset acquisition. The total acquisition amount, including capitalized acquisition expenses, amounts to SEK 31.4 million. This amount has been capitalized as license rights in the accounts.

EBITDA and EBITDA

The quarter presented the highest EBITDA in CellaVision's history, SEK 47.1million, an increase of 30 percent in comparison with the previous year (36.2). The EBITDA margin for the second quarter amounts to 35 percent (31). The improvement is explained by CellaVision's scalable business model where increased sales combined with lean business operations generate improved profit margins. For the six-month period, EBITDA amounted to SEK 93.3 million (77.4), corresponding to an EBITDA margin of 35 percent (31).

Net financial items

The Group's interest-bearing liabilities in the form of bank loans amounted to SEK 112.7 million (130.0). A loan of SEK 15.0 million was signed during the quarter as part of the financing of the acquisition of Clearbridge BioPhotonics. Interest expenses from bank loans amounted to SEK 0.3 million (0.3). 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 intercompany assets and interest on leasing liability in accordance with IFRS 16.

Cash flow

The Group's cash and cash equivalents at the end of the quarter amounted to SEK 91.3 million (115.5). The Group had a strong positive cash flow from operating activities which amounted to SEK 38.9 million (34.1) for the quarter. During the quarter, the cash position was reduced by dividends to shareholders of SEK 17.9 million (0) and a self-financed part of the acquisition of Clearbridge BioPhotonics of SEK 16.4 million (0). Total cash flow for the quarter amounted to SEK -20.3 million (18.1).

EBITDA per quarter and EBITDA margin rolling 12

Development in the geographical markets

Americas: SEK 47.7 million (28.8)

Sales increased by 66 percent in the Americas, to SEK 47.7 million (28.8) compared to last year's corresponding period, in which sales were adversely affected by the pandemic. In the U.S. and Canada, market conditions improved significantly as a result of successful vaccination programs, allowing CellaVision to increase its market activities. As an example, CellaVision attended its first live exhibition since the outbreak of COVID-19 in June, and is expected to attend more live exhibitions in the coming quarter. Sales is not yet at pre-pandemic levels but on a positive trajectory towards full recovery. The speed of the ongoing recovery is dependent on the activity level and a sales cycle of six to twelve months.

During the quarter, CellaVision has re-activated demonstrations of the DC-1 towards end users within laboratories. CellaVision expects to have early adopters among small/medium sized laboratories associated with larger laboratories. Here the value proposition for the DC-1 is particularly strong as CellaVision's total solution can establish a fully digitalized laboratory workflow.

Central and South America remain affected by the pandemic, but the company noticed an increased interest in the digital cell morphology solutions for large and small/medium sized laboratories during the quarter.

APAC: SEK 29.9 million (32.6)

Sales in APAC decreased by 8 percent to SEK 29.9 million (32.6) compared to a strong second quarter the previous year. CellaVision's key markets in China, Japan and Southeast Asia continue to perform well although somewhat lower than last year in the wake of the COVID-19 resurgence, which affected the activity level with most exhibitions and live congresses being postponed. Many markets in APAC are still heavily impacted by COVID-19 and restrictions are still in place in a number of countries, making effective market activities more difficult to carry through.

CellaVision DC-1 is cleared for sales in all CellaVision's markets except China, where the initiated registration process is ongoing. Although the electromagnetic pulse (EMP) test has been approved in Europe and the U.S., the EMP test conducted in China failed to fulfil its acceptance criteria. Repetition of the EMP test will cause a delay in the Chinese registration process and new estimated sales clearance is 2022.

The DC-1 has been well-received in Indonesia and Australia. CellaVision is working with distribution partners and laboratories to gain more exact knowledge of the market opportunities for the DC-1 in the different geographies across APAC.

APAC represents a key region for expansion of RAL reagents to countries outside of Europe. The evaluations of RAL reagents initiated in the previous quarter continues to progress according to plan. In Hong Kong and South Korea, the evaluations and reg-

istrations of the RAL stains are complete and market launch has begun. In China, the registration process has been completed and market launch is expected during 2021. In Southeast Asia, a new stain formulation is being tested as a first step before starting product registrations in countries across the region.

EMEA: SEK 57.8 million (56.6)

In EMEA, sales grew by 2 percent to SEK 57.8 million (56.6) compared with the second quarter of 2020. In the beginning of the second quarter, significant COVID-19 restrictions were prevalent across the EMEA region. However, towards the end or the quarter restrictions were alleviated as a result of implementing vaccination programs, which provided an increased opportunity for physical interaction.

The hospital landscape across EMEA is more fragmented compared to North America. The fragmentation is driven by different hospital systems across multiple countries, public and private laboratories as well as hospital affiliations where small and larger laboratories are operated independently (i.e. standalone hospitals) or as associated entities (i.e. integrated hospitals).

The value proposition for CellaVision DC-1 is highly applicable within integrated hospital networks. Nevertheless, the roll out of the DC-1 across EMEA signals that the value proposition for DC-1 is also appreciated at standalone hospitals.

In the quarter the company has seen increased sales of advanced software applications, in particular CellaVision® Remote Review Software. This software enables connectivity between CellaVision instruments, hence creating workflow advantages for both standalone- and integrated hospitals.

The underlying growth of RAL reagents is unchanged, but due to COVID-19 related supply shortage of generic materials, reagent sales declined by 9 percent compared to last year's corresponding period. The supply difficulties have resulted in sales orders equivalent to SEK 3.0 million being postponed with expected delivery in July.

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.

During the quarter, CellaVision acquired the exclusive rights to 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. A long-term research effort to further develop and adapt the technology to CellaVision's needs has been initiated.

CellaVision's patent portfolio at the end of the period, grants rights to 25 patented inventions and 106 granted patents.

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. The interim report has not been reviewed by the company's auditors.

Lund, July 20, 2021

Mikael Worning Christer Fåhraeus Åsa Hedin Gunnar B. Hansen Chairman of the Board Member of the Board Member of the Board Member of the Board

Employee representative

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

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

Consolidated income statement in summary

Amounts in ' 000 SEK Apr-Jun 2021 Apr-Jun 2020 Jan-Jun 2021 Jan-Jun 2020 Jan-Dec 2020
Net sales 135,451 118,046 269,405 252,476 471,443
Cost of goods sold -41,880 -40,176 -82,849 -82,296 -158,402
Gross profit 93,572 77,870 186,556 170,180 313,041
Sales and marketing expenses -24,543 -24,694 -49,066 -53,516 -100,549
Administration expenses -15,198 -11,957 -29,867 -27,120 -50,966
R&D expenses
Operating profit
-15,143
38,688
-12,940
28,279
-30,527
77,097
-27,752
61,792
-51,253
110,273
Interest income and financial exchange rate gains 1,675 7,157 1,746 7,779 7,118
Interest expense and financial exchange rate losses -1,459 -1,086 -4,311 -9,729 -5,163
Profit/loss before tax 38,903 34,351 74,532 59,842 112,228
Tax -7,904 -7,099 -15,042 -12,314 -22,748
Profit/loss for the period 31,000 27,252 59,490 47,529 89,480
Other comprehensive income:
Components not to be reclassified to net profit:
Effect on revaluation of pensions
Tax effect on revaluation of pensions
45 200 -35 -16 -171
-13 -56 10 4 48
Sum of Components not to be reclassified to net profit: 32 144 -25 -11 -123
Components to be reclassified to net profit:
a) Financial assets at fair value
Reclassified to operating result 0 1,007 -1,388 2,854 4,034
Revaluation of financial assets 0 4,679 0 -289 1,193
Income tax relating to financial assets 0 -1,215 286 -549 -1,117
b) Translation difference
Translation difference in the group -4,480 -16,056 1,772 800 -12,223
Sum of Components to be reclassified to net profit: -4,480 -11,586 670 2,815 -8,112
Sum of other comprehensive income: -4,448 -11,442 645 2,804 -8,236

Comprehensive result for the period 26,552 15,810 60,135 50,333 81,244

Per share data

Per share data Apr-Jun 2021 Apr-Jun 2020 Jan-Jun 2021 Jan-Jun 2020 Jan-Dec 2020
Earnings per share, before and after dilution, SEK */ 1.30 1.14 2.49 1.99 3.75
Equity per share, SEK 19.78 16.72 19.78 16.72 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 368.60 281.00 368.60 281.00 312.40
Dividend per share 0.75 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 Q2 2021 Q1 2021 Q4 2020 Q3 2020 Q2 2020 Q1 2020
Net sales 135,451 133,954 130,990 87,977 118,046 134,430
Gross profit 93,572 92,985 85,836 57,025 77,870 92,310
Gross margin in % 69 69 66 65 66 69
Expenses -54,884 -54,575 -53,965 -40,415 -49,591 -58,797
EBITDA 47,108 46,193 40,805 24,648 36,221 41,221
Net profit 31,000 28,490 28,603 13,348 27,252 20,277
Cash flow -20,330 8,807 9,242 -21,184 18,097 -5,209

Consolidated balance sheet in summary

Amounts in ' 000 SEK 06/30/2021 06/30/2020 03/31/2021 12/31/2020
Assets
Intangible assets 342,776 304,475 309,525 300,883
Tangible assets 47,968 51,668 48,540 47,428
Deferred tax assets 0 0 0 0
Financial assets 21,818 22,434 22,009 21,648
Inventory 91,724 69,825 83,342 83,660
Trade receivables 76,003 65,456 83,522 71,030
Other receivables 54,669 35,510 47,430 41,114
Cash and bank 91,271 115,492 112,832 102,262
Total assets 726,228 664,860 707,200 668,025
Equity and liabilities
Equity 471,863 398,706 463,200 429,617
Deferred tax liability 45,253 41,242 44,596 43,377
Other provisions 4,081 5,353 4,076 3,982
Long-term debt, interest-bearing 83,528 108,339 81,371 86,904
Short-term debt, interest-bearing 48,121 47,632 48,849 45,874
Short-term debt, non interest-bearing 43,178 42,045 38,389 35,531
Trade payables 28,149 19,450 24,829 20,865
Warranty provisions 2,055 2,093 1,890 1,875
Total equity and liabilities 726,228 664,860 707,200 668,025

Consolidated statement of changes in equity

Amounts in ' 000 SEK 06/30/2021 06/30/2020 03/31/2021 12/31/2020
Balance at the beginning of the year 429,617 348,373 429,617 348,373
Dividend -17,889 0 0 0
Net profit for the year 59,490 47,529 28,490 89,480
Comprehensive result for the period 645 2,804 5,093 -8,236
Balance at the end of the year 471,863 398,706 463,200 429,617

Cash flow analysis in summary

Amounts in ' 000 SEK Apr-Jun 2021 Apr-Jun 2020 Jan-Jun 2021 Jan-Jun 2020 Jan-Dec 2020
Result before taxes 38,903 34,351 74,532 59,842 112,228
Adjustment for items not included in cash flow 12,979 4,401 18,753 11,206 15,630
Taxes -6,440 -6,170 -12,858 -10,323 -20,931
Cash flow from operations before changes in working capital 45,443 32,582 80,427 60,725 106,926
Changes in working capital -6,556 1,496 -15,320 -11,233 -35,802
Cash flow from operations 38,887 34,078 65,107 49,492 71,124
Acquisitions 0 0 0 -1,269 -1,269
Capitalization of development costs -9,305 -6,563 -17,806 -12,918 -25,524
Acquisitions of intangible non-current assets -31,732 110 -31,763 -41 -64
Acquisitions of financial non-current assets -2 180 -20 -58 -33
Acquisitions of tangible non-current assets -3,021 -2,330 -7,028 -3,909 -8,069
Cash flow from investment activities -44,059 -8,603 -56,617 -18,195 -34,959
Acquired loans 15,000 1,518 19,530 1,827 3,041
Amortization of loans -9,614 -6,575 -16,330 -15,652 -28,721
Amortization of leasing debts -2,655 -2,320 -5,326 -4,583 -9,537
Dividend -17,889 0 -17,889 0 0
Cash flow from financing activities -15,158 -7,378 -20,014 -18,408 -35,218
Total cash flow -20,330 18,097 -11,524 12,889 948
Liquid funds at beginning of period 112,832 99,305 102,262 102,312 102,312
Exchange rate fluctuations in liquid funds -1,231 -1,910 533 291 -998
Liquid funds at end of period 91,271 115,492 91,271 115,492 102,262

Disclosures regarding interest expense:

Interest expenses for Jan-Jun amount to SEK 877 thousand whereof SEK 293 thousand is attributable to leasing in accordance with IFRS 16.

Income statement - parent company

Amounts in ' 000 SEK Apr-Jun 2021 Apr-Jun 2020 Jan-Jun 2021 Jan-Jun 2020 Jan-Dec 2020
Net sales 112,619 93,235 218,534 199,511 372,387
Cost of goods sold -27,120 -23,404 -50,695 -48,531 -90,677
Gross profit 85,499 69,831 167,840 150,980 281,711
Sales and marketing expenses -19,229 -20,432 -38,485 -43,588 -78,528
Administration expenses -12,146 -9,126 -24,180 -20,954 -40,846
R&D expenses -21,951 -18,446 -44,824 -38,476 -72,057
Operating profit 32,173 21,827 60,351 47,961 90,279
Interest income and financial exchange gains 1,654 6,950 1,701 7,572 13,185
Interest expense and financial exchange losses -1,119 -782 -3,614 -8,946 -3,406
Profit before income tax 32,707 27,996 58,438 46,587 100,058
Taxes -6,938 -5,991 -12,239 -9,970 -20,097
Net profit 25,769 22,005 46,199 36,617 79,962
Comprehensive profit for the period 25,769 22,005 46,199 36,617 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 25,769 22,005 46,199 36,617 79,962
Statement of Comprehensive Income

Balance sheet - parent company

Amounts in ' 000 SEK 06/30/2021 06/30/2020 03/31/2021 12/31/2020
Assets
Intangible assets 5,579 6,694 5,493 5,707
Tangible assets 4,805 6,035 5,010 5,138
Deferred tax assets 668 3,678 668 668
Financial assets 282,309 263,014 263,014 263,014
Inventory 63,102 36,212 56,291 56,009
Trade receivables 58,637 44,039 62,305 55,176
Receivables from group companies 15,130 5,159 4,154 3,525
Other receivables 51,997 34,656 43,899 40,383
Cash and bank 68,278 89,872 84,401 72,958
Total assets 550,505 489,361 525,235 502,578
Equity and liabilities
Equity 388,788 317,133 380,907 360,477
Other provisions 65 1,868 15 0
Long-term debt, interest-bearing 63,941 77,660 58,354 62,935
Short-term debt, interest-bearing 26,085 23,895 23,342 22,886
Short-term debt, non interest-bearing 30,614 28,606 25,027 26,070
Trade payables 21,571 15,006 20,257 16,075
Liabilities to group companies 17,387 23,099 15,442 12,260
Warranty provisions 2,055 2,093 1,890 1,875
Total equity and liabilities 550,505 489,361 525,235 502,578

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

Apr-Jun 2021 Apr-Jun 2020
Amounts in ' 000 SEK Instruments Reagents Other Total Instruments Reagents Other Total
Americas 26,769 301 20,670 47,740 14,317 788 13,665 28,770
APAC 27,022 230 2,621 29,873 32,508 280 -160 32,628
EMEA 26,098 19,836 11,904 57,839 28,070 21,232 7,346 56,648
Total 79,889 20,367 35,195 135,451 74,895 22,300 20,851 118,046
Jan-Jun 2021 Jan-Jun 2020
Amounts in ' 000 SEK Instruments Reagents Other Total Instruments Reagents Other Total
Americas 46,880 614 42,004 89,498 49,423 1,202 32,212 82,837
APAC 45,364 1,205 7,446 54,015 52,105 683 5,485 58,273
EMEA 59,596 41,508 24,789 125,892 47,502 42,847 21,018 111,366
Total 151,840 43,327 74,239 269,405 149,030 44,732 58,714 252,476

Other refers to software, spare parts and consumables.

NOTE 5. FINANCIAL INSTRUMENTS

06/30/2021 06/30/2020
Amounts in ' 000 SEK Reported value Fair value Reported value Fair value
Financial assets
Derivative assets 0 0 359 359
Financial liabilities
Derivative liabilities 0 0 -1,623 -1,623

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 06/30/2021 06/30/2020
Right of use assets
Land and buildings 16,771 24,247
Inventories 2,970 2,357
Total right of use assets 19,741 26,604
Tangible fixed assets that are not right of use assets
Land and buildings 15,242 14,192
Inventories 12,985 10,871
Total tangible fixed assets that are not right of use assets 28,227 25,064
Total tangible fixed assets 47,968 51,668

The tangible fixed assets amounted to SEK 48.0 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

06/30/2021 06/30/2020
Number of employees 184 182
Of which men 113 110
Of which women 71 72

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

NOTE 8. SIGNIFICANT EVENTS AFTER THE PERIOD CLOSE

CellaVision has given notice of termination of the distribution agreement with Mindray Medical International Co., Ltd. The agreement signed in 2018 will be terminated by February 2022. Under the agreement, Mindray has focused on sales of CellaVision's large instruments in the Chinese market. The termination is a natural result of Mindray developing its own digital cell morphology solution. As the collaboration with Mindray resulted in an installed base of 40 systems over 3 years, the discontinued cooperation is expected to have a limited impact on CellaVision's sales and earnings. The decision to terminate distribution via Mindray does not in any way alter CellaVision's strategic direction to commercialize its offerings via the indirect sales model. CellaVision's commitment to, and belief in the Chinese market is unchanged. CellaVision will continue to strengthen and support its strategic alliances with global players in medical technology to provide digital solutions for end users in all parts of the world.

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 attributable 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

Apr-Jun 2021 Apr-Jun 2020 Jan-Jun 2021 Jan-Jun 2020 Jan-Dec 2020
Profit/loss for the period, KSEK 31,000 27,252 59,490 47,529 89,480
Number of shares 23,851,547 23,851,547 23,851,547 23,851,547 23,851,547
Net earnings per share 1.30 1.14 2.49 1.99 3.75

Equity per share

Apr-Jun 2021 Apr-Jun 2020 Jan-Jun 2021 Jan-Jun 2020 Jan-Dec 2020
Equity, KSEK 471,863 398,706 471,863 398,706 429,617
Number of shares 23,851,547 23,851,547 23,851,547 23,851,547 23,851,547
Equity per share 19.78 16.72 19.78 16.72 18.01

Equity-asset ratio

KSEK Apr-Jun 2021 Apr-Jun 2020 Jan-Jun 2021 Jan-Jun 2020 Jan-Dec 2020
Equity 471,863 398,706 471,863 398,706 429,617
Balance sheet total 726,228 664,860 726,228 664,860 668,025
Equity ratio 65% 60% 65% 60% 64%

Gross margin

KSEK Apr-Jun 2021 Apr-Jun 2020 Jan-Jun 2021 Jan-Jun 2020 Jan-Dec 2020
Net sales 135,451 118,046 269,405 252,476 471,443
Gross profit 93,572 77,870 186,556 170,180 313,041
Gross margin 69% 66% 69% 67% 66%

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

Operating margin
KSEK Apr-Jun 2021 Apr-Jun 2020 Jan-Jun 2021 Jan-Jun 2020 Jan-Dec 2020
Net sales 135,451 118,046 269,405 252,476 471,443
Operating profit 38,688 28,279 77,097 61,792 110,273
Operating margin 29% 24% 29% 24% 23%

EBITDA

KSEK Apr-Jun 2021 Apr-Jun 2020 Jan-Jun 2021 Jan-Jun 2020 Jan-Dec 2020
Operating profit 38,688 28,279 77,097 61,792 110,273
Depreciation 8,420 7,942 16,203 15,650 32,622
EBITDA 47,108 36,221 93,300 77,442 142,895

Net sales

Apr-Jun 2021 Apr-Jun 2021 Apr-Jun 2020 Apr-Jun 2020
(%) KSEK (%) KSEK
Last period 118,046 112,448
Organic growth 22.6% 29,015 -15% -17,316
Currency effect -8.0% -11,719 -3% -3,214
Structural growth 0.1% 109 23% 26,128
Current period 14.7% 135,451 5% 118,046

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 is 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 and the Swedish Securities Markets Act. The information was submitted for publication at 7:20 a.m. CEST on July 20, 2021.

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

Financial calendar

Activity Date
Interim Report January-September October 22
Year-end bulletin 2021 February 4, 2022

NOTE: This is an unofficial translation of the original Interim Report, which is in Swedish. 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.