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CellaVision Interim / Quarterly Report 2019

Oct 23, 2019

3025_10-q_2019-10-23_314e486d-3f63-4140-a620-03eb023d89f2.pdf

Interim / Quarterly Report

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Interim report Jan-Sept 2019

Organic sales growth Q3, 2019: 8% (33)

Operating margin Q3, 2019: 22.9% (24.9)

(MSEK) Jul-Sep 2019 Jul-Sep 2018 Jan-Sep 2019 Jan-Sep 2018 Jan-Dec 2018
Net sales 95.6 84.3 311.9 253.8 364.8
Gross profit 72.8 62.2 236.9 188.9 270.9
EBITDA 25.6 22.5 105.2 81.1 118.4
Operating profit 21.9 21.0 94.8 75.8 111.6
Operating margin, % 22.9 24.9 30.4 29.9 30.6
Profit/loss before tax 21.5 20.7 94.2 76.1 112.1
Total cash flow 27.7 22.2 48.9 10.1 14.4
Equity ratio, % 74.7 78.7 74.7 78.7 77.9

Continued growth and acquisition of RAL Diagnostics

July 1–September 30, 2019

  • Net sales increased by 13 % to SEK 95.6 million (84.3).
  • Sales grew organically by 8% (33).
  • Operating profit increased to SEK 21.9 million (21.0).
  • The operating margin was 22.9% (24.9).
  • Profit before tax increased to SEK 21.5 million (20.7).
  • Earnings per share before and after dilution were SEK 0.72 (0.70).
  • Cash flow from operating activities increased SEK 32.5 million (26.1).

January 1–September 30, 2019

  • Net sales increased by 23 % to SEK 311.9 million (253.8).
  • Sales grew organically by 18% (6).
  • Operating profit increased to SEK 94.8 million (75.8).
  • The operating margin increased to 30.4 % (29.9).
  • Profit before tax increased to SEK 94.2 million (76.1).
  • Earnings per share before and after dilution were SEK 3.14 (2.48).
  • Cash flow from operating activities was SEK 101.0 million (61.3).

Significant events after the period close

• On October 1, CellaVision completed the acquisition of RAL Diagnostics (RAL) for a purchase price of SEK 268 million on a cash and debt-free basis. RAL develops and sells high quality products for sample preparation in hematology, microbiology, cytology and pathology. CellaVision and RAL together create an increased customer value in digital morphology by offering a complete and integrated solution for the hematology laboratory.

CEO's comments

The third quarter of 2019 was a stable quarter for CellaVision, given the strong quarter in 2018, with organic growth of eight percent. Sales were SEK 95.6 million (84.3). There was strong development in APAC, where sales grew by 54 percent and the Americas also reported a good quarter, with growth of 16 percent. EMEA was weaker, with negative growth of 18 percent.

Profitability was good during the quarter, with an operating profit of SEK 21.9 million (21.0), corresponding to an operating margin of 22.9 percent (24.9). The profitability is a result of CellaVision's effective indirect business model and good gross margins. Cash flow from operating activities for the quarter was SEK 32.5 million (26.1). The first nine months' cash flow from operating activities was SEK 101.0 million (61.3).

On October 1, CellaVision acquired the France-based company RAL Diagnostics (RAL). RAL operates in high-quality sample preparation in hematology, microbiology, pathology and cytology.

Cash flow progressed well in the quarter and was SEK 27.7 million (22.2), thus increasing net cash to SEK 218.2 million (164.4). A large part of the net cash will be used in the acquisition of RAL.

Market development

The Americas developed well in the quarter and sales grew by 16 percent to SEK 46.4 million (40.1). In the USA and Canada positive growth continues, with an increasing number of installations at end customers despite the relatively well-penetrated market. We also see improved sales of applications and software. Brazil, where we established our own organization for local market support in 2017, is now also reporting rising sales. For the first nine months of the year growth in the region is 29 percent.

EMEA reported a weaker quarter, with 18 percent negative growth, after having sales rising for six consecutive quarters. In the past 18 months we have considerably increased our

activities in this region by establishing our own organizations for market support in the Middle East, France, the German-speaking countries of Europe, the United Kingdom/Ireland, Spain/ Portugal and Italy. These teams are now fully operational and the growth for the first nine months of the year was 16 percent.

APAC reported a strong quarter, with 54 percent growth. We conduct most of our marketing activities in all our markets, not least China, Japan and Australia, and continue to see growing interest in CellaVision's products and solutions. For the first nine months of the year growth in the region was 16 percent.

Segment expansion - the acquisition of RAL is a natural step in CellaVision's strategy

The acquisition of RAL was completed on October 1, 2019 and since then is part of CellaVision.

RAL`s products in sample preparation are turning to an already developed market with other players in competition, unlike CellaVision's market before the acquisition, where traditional microscopy is replaced by digital microscopy in hematology. With products in sample preparation, CellaVision gets a future recurring revenue stream and the opportunity to improve sample preparation quality, which is of great importance for the final results of blood analysis.

We have started a series of activities to develop the opportunities this acquisition provides for realizing synergies. The now integrated product range and potential to standardize workflows at laboratories the world over means an increase in CellaVision's addressable market in hematology to a total of about six billion SEK.

RAL holds a strong position in EMEA, but has a selective presence in the Americas and APAC markets, where CellaVision has established a strong position in recent years. Consequently, there is a sound basis for effective sales expansion of RAL's solutions globally through CellaVision's market support organization and partnership.

The acquisition of RAL also supplies CellaVision with considerable experience and knowledge in microbiology, cytology and pathology, which opens up new future opportunities to apply CellaVision's technology beyond hematology.

Geographical expansion

Geographical expansion is crucial to CellaVision's growth. In the third quarter of the year we did not establish any new organizations for local market support, and we are now fully operative in our latest establishments. We will strengthen the organization in some of our current markets to meet growing demand. Altogether CellaVision now has 17 local organizations offering market support in more than 30 countries.

Innovation

The CellaVision® DC-1, our new product for small and mid-size laboratories, was CE marked in February. The reception from our various distribution partners has been positive and most of them have now launched the CellaVision® DC-1 in their own sales channels. Step by step, we are now increasing production and delivery volumes. There will be full industrial production from 2020 onwards.

In 2019 we achieved commercial approval for the CellaVision® DC-1 in a number of important markets in addition to the EU countries. Examples are Canada, Australia, Japan, India, Korea, Brazil and several more countries. We have also initiated the action required to take the next step in the application process for sales approval of the CellaVision® DC-1 in the USA and China in 2020.

Compared with the previous year we have grown the organization in innovation by 33 percent and the cost of research and development reduces profit for the quarter by SEK 15.8 million (10.9). Going forward, we will continue to increase our investments, including recruiting talent in research and development, to secure our future innovation power and our growth opportunities in the short and long term.

Zlatko Rihter, President and CEO

Sales, performance and investments

Sales and exchange rate effects

Net sales for the Group in the third quarter were SEK 95.6 million (84.3), an increase of 13 percent compared with the corresponding period in 2018. CellaVision's sales often fluctuate between different quarters, both for individual regions and for the Group as a whole.

CellaVision invoices more than 90 percent of its net sales in euro or US dollars, which means that exchange rate fluctuations have an impact on the company's reported net sales and earnings. Adjusted for positive exchange rate effects of five percent, net sales increased organically by eight percent compared with the corresponding quarter in 2018.

The Group's net sales in the first three quarters of the year amounted to SEK 311.9 million (253.8). Adjusted for positive exchange rate effects of four per cent, the organic growth corresponds to 19 percent compared with the corresponding period in 2018.

Total operating expenses in the third quarter increased to SEK 50.9 million (41.2). The increase is due to planned long-term initiatives to broaden the product portfolio and increase market presence.

CellaVision is running several development projects aimed at strengthening the company's product offer. Total research and development costs increased to SEK 18.9 million (13.7), of which SEK 3.0 million (2.9) of the expenses has been capitalized. The main part of the capitalized expenditure is related to application development.

The project is in the completion phase and the system has been granted CE marking. This makes the system available for sale in the countries that accept CE marking. The first systems have been delivered and the rate of production is gradually increasing. Depreciation of the CellaVision® DC-1 was started in the third quarter. Clinical studies whose results are to be used for registration in the USA and China have been started.

Operating profit and operating margin

Operating profit for the quarter was SEK 21.9 million (21.0), with an operating margin of 22.9 percent (24.9). Operating profit for the first three quarters of the year was SEK 94.8 million (75.8) with an operating margin of 30.4 percent (29.9). The improved performance is due to an increased sales volume with a better gross margin.

Net financial income

CellaVision has no interest-bearing liabilities, except leasing debt. Net financial income is mainly attributable to exchange rate gains/losses on intra-group transactions and interest on lease liabilities in accordance with IFRS 16.

Cash flow

The Group's cash and cash equivalents at the close of the quarter amounted to SEK 218.2 million (164.4). The Group's total cash flow for the quarter was SEK 27.7 million (22.2). Decreased trade receivables in the quarter are the main reason for the cash flow increase compared with the previous year.

Acquisition of RAL Diagnostics

CellaVision completed its acquisition of RAL Diagnostics (RAL) after the close of the period. RAL manufactures products for sample preparation in hematology, pathology, cytology and microbiology. In 2018 RAL had sales of about SEK 87 million and an EBITDA margin of about 15 per cent. The cash purchase price for RAL is set at SEK 268 million on a cash and debt-free basis and is financed through a combination of CellaVision's own liquid funds and bank loans. RAL is located in Bordeaux, France, and has about 45 employees. The acquisition is estimated to have a marginal impact on CellaVision's earnings per share for the current financial year.

Development in geographical markets

Americas: SEK 46.4 million (40.1)

Sales in the Americas increased by 16 percent to SEK 46.4 million (40.1) compared with the same period in the previous year. The American market continues to report positive growth with increased market share and an incipient replacement market. The company's North American organization is continuing to address the laboratories that have not yet converted to CellaVision's solution. There is increasing interest in the company's products in Latin America, where Brazil in particular has got well under way.

Software sales made a positive contribution in the quarter. Sales of the CellaVision® Advanced RBC Application developed well after sales approval from the American authorities, and the CellaVision® Remote Review also made a contribution to sales in the quarter.

CellaVision participated in the AACC Annual Scientific Meeting & Clinical Lab Expo in Anaheim California in the quarter. The meeting is one of the largest of its kind in the world and the company's new analyzer for small and mid-size labs, the CellaVision® DC-1, attracted great interest among the visitors. Further, several training sessions for the company's different distribution partners were held in Latin America in the quarter.

APAC: SEK 28.0 million (18.2)

Sales in APAC increased by 54 percent to SEK 28.0 million (18.2), compared with the same period in the previous year. The strongest contributors to sales in the quarter were the markets in China and Japan. Sales will continue to fluctuate between regions and individual quarters. During the quarter the company also delivered analyzers to both India and Korea. The effect of CellaVision's strategy with an organization for local market support is showing good results.

Software sales developed well in the quarter, where the CellaVision® Remote Review software and CellaVision® Proficiency training tool contributed particularly to sales.

CellaVision's subsidiary in Japan celebrated its ten-year anniversary and presented the CellaVision® DC-1 for the first time to the Japanese market and end customers and distributors. At the two-day Xi Jing Morphology Class, there were 600 participants in attendance in Xian, China and about 80,000 followed the event online.

EMEA: SEK 21.2 million (26.0)

Sales in EMEA decreased by 18 percent to SEK 21.2 million (26.0) compared with the same period in the previous year. Sales fluctuate between regions and individual quarters. Interest in the company's solutions is great and potential for continued penetration is good in EMEA. Sales of the CellaVision® DC-1 got under way in the quarter and the company's consistent strategy of focusing on local organizations for market support is having an effect.

Software sales were weaker in the quarter, while aftermarket sales were relatively good.

During the quarter the company exhibited at two congresses; the IBMS Institute of Biomedical Science Congress in Birmingham, United Kingdom and the DGKL Deutscher Kongress für Laboratoriumsmedizin in Magdeburg, Germany.

Other information

Research and development

The production rate of CellaVision's new system for small and mid-size laboratories, the CellaVision® DC-1, will gradually increase during the year, with a focus on streamlining and improving efficiency in production. CellaVision is running several development projects aimed at strengthening the offer to the company's customers, in which the work on the CellaVision® DC-1 has led to technological advances that in the long term may be used in new analyzers. In addition, work is being carried out to develop new applications for both older and newer analyzers.

At the close of the period CellaVision's patent portfolio contained 19 patented inventions and 59 registered patents.

The Group continuously capitalizes expenditure on new development. Capitalized expenditure for development projects increased during the quarter to SEK 3.0 million (2.9). Total research and development costs, before capitalization, amounted to SEK 18.9 million (13.7).

Personnel

The number of employees of the Group, restated as full-time equivalents, was 136 (111) at the close of the quarter. Of these, 87 were men (74) and 48 women (37).

Information concerning risks and uncertainties

Reduced demand and changes in exchange rates constitute uncertainties but not material risks. For a more detailed description of the risks and uncertainties facing CellaVision, please refer to the risk analysis and Notes 2 and 5 in the Annual Report for 2018.

New tax rates

In stage one the corporate tax rate will be reduced from 22 percent to 21.4 percent for financial years starting on or after January 1, 2019. In stage two the corporate tax rate will be decreased to 20.6 percent from the financial year starting on January 1, 2021.

The company has made an assessment of when temporary differences will be reversed and the effect on deferred tax liabilities and deferred tax assets. The company applies 21.4 percent to the temporary differences to be reversed or utilized in 2019 and 2020 and 20.6 percent on others to be reversed or utilized as of 2021.

Introduction of IFRS 16

As of January 1, 2019, CellaVision applies IFRS 16 Leases. CellaVision has rental agreements for office premises and leases for cars that with the introduction of IFRS 16 are recognized on the balance sheet. The introduction of IFRS 16 has meant an increase in the balance sheet total of SEK 31.6 million. For more information about the effect of introducing IFRS 16, please see Note 1 and the consolidated cash flow statement.

The Nomination Committee and the Annual General Meeting in 2020

The Nomination Committee for the Annual General Meeting in 2020

In accordance with a resolution of the 2019 Annual General Meeting the Nomination Committee shall consist of representatives of each of the four largest shareholders terms of voting rights at the end of August 2019. The Chairman of the Board, Sören Mellstig, convenes the Nomination Committee and may participate in the work as an adjunct.

Ahead of the Annual General Meeting in 2020, the Nomination Committee consists of: Christer Fåhraeus, (appointed by Christer Fåhraeus with Companies) Nicklas Hansen (appointed by William Demant Invest A / S), Bo Lundgren (appointed by Swedbank Robur Funds) and Joel Eklund (appointed by Grenlunden CEVI AB)

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 2020

CellaVision's Annual General Meeting in 2020 will be held in Lund at three o´clock CET, on April 23, 2020. 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 and CEO

The Board of Directors and the Presisdent/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 and performance and describes material risks and uncertainties to which the parent company and the companies in the group are exposed.

Lund, October 23, 2019

Sören Mellstig Christer Fåhraeus Åsa Hedin Chairman of the Board Member of the Board Member of the Board

Anna Malm Bernsten Niklas Prager Jurgen Riedl Member of the Board Member of the Board Member of the Board

Stefan Wolf Zlatko Rihter Member of the Board President/CEO

.

Consolidated Income Statement in Summary

All amount in ' 000 SEK Jul-Sep 2019 Jul-Sep 2018 Jan-Sep 2019 Jan-Sep 2018 Jan-Dec 2018
Net sales 95,599 84,337 311,938 253,847 364,812
Cost of goods sold -22,845 -22,130 -75,063 -64,936 -93,946
Gross profit 72,754 62,207 236,875 188,911 270,866
Sales and marketing expenses -24,388 -21,409 -71,073 -59,585 -82,362
Administration expenses -10,673 -8,898 -30,241 -26,274 -37,644
R&D expenses -15,824 -10,875 -40,810 -27,269 -39,253
Operating profit 21,870 21,024 94,751 75,782 111,607
Interest income and financial exchange rate gains 564 -53 1,799 1,255 2,010
Interest expense and financial exchange rate losses -956 -253 -2,317 -921 -1,520
Profit/loss before tax 21,478 20,719 94,233 76,117 112,097
Tax -4,307 -3,919 -19,446 -16,976 -23,408
Profit/loss for the period 17,171 16,800 74,787 59,141 88,688
Other comprehensive income:
Components not to be reclassified to net profit:
0 0 0 0 0
Components to be reclassified to net profit:
a) Financial assets at fair value
Reclassified to operating result 1,384 147 3,274 -417 -374
Revaluation of financial assets -2,890 4,797 -8,544 -7,424 -4,947
Income tax relating to financial assets 322 -1,088 1,128 1,725 1,137
b) Translation difference
Translation difference in the group 1,043 196 1,715 741 797
Sum of Components to be reclassified to net profit: -140 4,052 -2,428 -5,375 -3,387
Sum of other comprehensive income: -140 4,052 -2,428 -5,375 -3,387
Comprehensive result for the period 17,030 20,852 72,359 53,766 85,302

Per share data

Per share data Jul-Sep 2019 Jul-Sep 2018 Jan-Sep 2019 Jan-Sep 2018 Jan-Dec 2018
Earnings per share, before and after dilution, SEK */ 0.72 0.70 3.14 2.48 3.72
Equity per share, SEK 13.71 10.85 13.71 10.85 12.17
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 381.50 271.00 381.50 271.00 191.50
Dividend per share 0.00 0.00 1.50 1.50 1.50

* Based on the profit/loss for the period divided by the aver-

age number of shares in issue

Quarterly earnings trend

All amount in ' 000 SEK Q3 2019 Q2 2019 Q1 2019 Q4 2018 Q3 2018 Q2 2018
Net sales 95,599 112,448 103,891 110,965 84,337 91,899
Gross profit 72,754 87,095 77,026 81,955 62,207 68,981
Gross margin in % 76.1 77.5 74.1 73.9 73.8 75.1
Expenses -50,885 -49,158 -42,081 -46,131 -41,182 -37,409
Operating profit 21,870 37,937 34,945 35,824 21,024 31,572
Net profit 17,171 30,279 27,337 29,548 16,800 23,321
Cash flow 27,734 -23,845 45,001 4,287 22,223 -9,660

Consolidated Balance Sheet in Summary

All amount in ' 000 SEK 09/30/2019 09/30/2018 06/30/2019 12/31/2018
Assets
Intangible assets 75,058 63,654 73,500 67,818
Tangible assets 6,231 4,376 6,484 6,815
Right of use assets 26,325 0 27,926 0
Deferred tax assets 0 0 0 0
Financial assets 3,612 3,200 3,600 3,579
Inventory 37,426 27,508 35,000 34,454
Trade receivables 57,931 51,364 66,782 75,813
Other receivables 12,715 14,512 14,304 15,246
Cash and bank 218,185 164,422 190,196 169,057
Total assets 437,483 329,036 417,792 372,782
Equity and liabilities
Equity 326,956 258,840 309,926 290,375
Deferred tax liability 9,183 7,357 9,012 8,059
Other provisions 2,458 3,090 2,458 2,458
Leasing debt, long-term 20,384 0 21,990 0
Leasing debt, short-term 6,794 0 6,506 0
Short term debt 49,371 38,568 45,065 43,385
Trade payables 20,375 19,642 20,897 26,753
Warranty provisions 1,962 1,539 1,938 1,752
Total equity and liabilities 437,483 329,036 417,792 372,782

Consolidated statements of changes in equity

All amount in ' 000 SEK 09/30/2019 09/30/2018 06/30/2019 12/31/2018
Balance at the beginning of the year 290,375 240,851 290,375 240,851
Dividend -35,777 -35,777 -35,777 -35,777
Net profit for the year 74,787 59,141 57,616 88,688
Comprehensive result for the period -2,428 -5,375 -2,287 -3,387
Balance at the end of the year 326,956 258,840 309,926 290,375

Cash Flow Analysis in Summary

All amount in ' 000 SEK Jul-Sep 2019 Jul-Sep 2018 Jan-Sep 2019 Jan-Sep 2018 Jan-Dec 2018
Result before taxes 21 478 20 719 94 233 76 117 112 097
Adjustment for items not included in cash flow 11 619 7 770 15 216 12 060 14 499
Taxes -8 754 -5 003 -18 354 -16 853 -16 075
Cash flow from operations before changes in working
capital 24 343 23 487 91 095 71 325 110 521
Changes in working capital 8 197 2 590 9 877 -10 010 -36 452
Cash flow from operations 32 540 26 077 100 972 61 315 74 069
Capitalization of development costs -3 044 -2 874 -10 894 -14 072 -18 419
Aquisitions in intangible non-current assets 0 0 0 0 -900
Aquisitions in financial non-current assets -12 -573 -33 -583 -962
Aquisitions in tangible non-current assets -432 -407 -990 -735 -3 576
Cash flow from investment activities -3 488 -3 854 -11 917 -15 390 -23 857
Amortization of leasing debts -1 318 0 -4 388 0 0
Dividend 0 0 -35 777 -35 777 -35 777
Cash flow from financing activities -1 318 0 -40 166 -35 777 -35 777
Total cash flow 27 734 22 223 48 889 10 148 14 434
Liquid funds at beginning of period 190 196 142 822 169 057 154 546 154 546
Exchange rate fluctuations in liquid funds 256 -623 239 -272 77
Liquid funds at end of period 218 185 164 422 218 185 164 422 169 057

Disclosures regarding IFRS 16:

Interest regarding leasing debt amounts to SEK 694 thousand Amortization of leasing debt amounts to SEK 4,388 thousand

Income Statement - Parent Company

All amount in ' 000 SEK Jul-Sep 2019 Jul-Sep 2018 Jan-Sep 2019 Jan-Sep 2018 Jan-Dec 2018
Net sales 93,878 84,786 307,359 249,420 358,349
Cost of goods sold -29,536 -28,837 -96,257 -77,484 -118,335
Gross profit 64,342 55,949 211,102 171,936 240,014
Sales and marketing expenses -16,910 -14,672 -49,141 -39,623 -55,552
Administration expenses -10,621 -8,898 -30,081 -26,274 -37,573
R&D expenses -18,868 -13,747 -51,705 -41,274 -57,672
Operating profit 17,943 18,633 80,176 64,766 89,217
Interest income and financial exchange gains 560 -57 1,699 1,245 1,991
Interest expense and financial exchange losses -697 -252 -1,564 -901 -1,485
Profit before income tax 17,806 18,325 80,311 65,111 89,722
Taxes -3,810 -4,031 -17,187 -14,324 -19,439
Net profit 13,995 14,294 63,125 50,787 70,284
Statement of Comprehensive Income
Net profit for the period 13,995 14,294 63,125 50,787 70,284
Other comprehensive income 0 0 0 0 0
Sum of other comprehensive income 0 0 0 0 0
Comprehensive profit for the period 13,995 14,294 63,125 50,787 70,284

Balance Sheet - Parent Company

All amount in ' 000 SEK 09/30/2019 09/30/2018 06/30/2019 12/31/2018
Assets
Intangible assets 8,507 11,373 9,021 11,189
Tangible assets 5,939 3,764 6,126 6,310
Deferred tax assets 2,844 2,078 2,844 2,844
Financial assets 3,582 3,205 3,582 3,582
Inventory 31,159 21,842 29,097 28,848
Trade receivables 52,518 48,350 62,099 70,676
Receivables from group companies 455 6,450 1,537 5,067
Other receivables 12,232 12,732 13,539 12,960
Cash and bank 208,629 153,495 181,649 160,664
Total assets 325,865 263,289 309,494 302,140
Equity and liabilities
Equity 253,602 206,758 239,607 226,255
Other provisions 2,458 3,090 2,458 2,458
Short term debt 34,900 25,898 32,091 32,386
Trade payables 20,030 18,967 20,483 26,161
Liabilities to group companies 12,913 7,037 12,916 13,129
Warranty provisions 1,962 1,539 1,938 1,752
Total equity and liabilities 325,865 263,289 309,494 302,140

Notes

NOTE 1. ACCOUNTING POLICIES

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. 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 2018, with the exclusion of what is stated below regarding the implementation of IFRS 16 Leases.

New standards applied as of January 1, 2019

As of January 1, 2019 CellaVision applies IFRS 16 Leases. IFRS 16 means that the former classification into operating and finance leases is replaced by a model in which assets and liabilities for virtually all leases is recognized as right of use assets in the statement of financial position. CellaVision has lease contracts for office premises and lease agreements for cars that are recognized as right of use assets in the statement of financial position as of January 1, 2019.

CellaVision has applied the simplified transition method (modified retrospective approach) upon transition. The method implies that the comparative year of 2018 has not been restated in accordance with the new standard, instead the effect of IFRS 16 is reported to its full extent in the opening balance as of January 1, 2019.

The effect of the transition to IFRS 16 has meant that right of use assets and a leasing debt of 31.6 MSEK is reported in the statement of financial position as of January 1, 2019. The majority of the right of use assets consist of premises, which amount to 29.9 MSEK. The value of right of use assets has been determined by the present value of the lease debts as of this date. For premises, CellaVision has used the company's estimated incremental borrowing rate of 3 % when discounting the remaining lease debt. For car leasing agreements, the implicit interest rate for each agreement has been used for calculation. For all right of use assets, the term of the agreements has been used for the assessment of the depreciation period applied.

The balance sheet total for the Group has thus increased upon implementation and reconciliation tables, non-IFRS measures, solvency and EBITDA, and earnings per share have been affected.

NOTE 2. SEGMENT REPORTING

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.

NOTE 3. ALLOCATION OF SALES

Jul-Sep 2019 Jul-Sep 2018
All amount in ' 000 SEK Instruments Other Instruments Other
Americas 24,377 22,013 26,386 13,706
APAC 24,910 3,110 17,179 1,047
EMEA 15,775 5,413 20,581 5,438
Total 65,062 30,537 64,147 20,190
Jan-Sep 2019 Jan-Sep 2018
All amount in ' 000 SEK Instruments Other Instruments Other
Americas 102,228 63,366 84,644 43,097
APAC 50,043 6,640 43,954 4,806
EMEA 65,183 24,477 57,726 19,620
Total 217,454 94,484 186,324 67,523

NOTE 4. FINANCIAL INSTRUMENTS

Jan-Sep 2019 Jan-Sep 2018
All amount in ' 000 SEK Reported
value
Fair value Reported
value
Fair value
Financial assets
Derivative assets 4 4 765 765
Financial liabilities
Derivative liabilities -10,826 -10,826 -8,837 -8,837

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 5. ACQUISITIONS

Acquisition of subsidiaries

On October 1, 2019, CellaVision AB acquired 100% of the share capital in RAL Diagnostics (RAL) for SEK 261.4 million (EUR 24.3 million), equivalent to 268 SEK million on cash-debt free basis. RAL is a French company, located just outside of Bordeaux with 45 employees. The company manufactures sample preparation products in hematology, pathology, cytology and microbiology. The acquisition of RAL is a step in the Group's strategic direction to be a leader in global digitalization and automation of blood analyses for both the human and veterinary segments. Combining CellaVision's and RAL's core technologies enables improved diagnostics outcome. By combining CellaVision's and RAL's core technologies we will together be able to improve quality within following critical areas for improved outcome: image quality, cell classification and lab workflow. The acquisition is financed through a combination of CellaVision's own cash and cash equivalents and a bank loan arranged by Skandinaviska Enskilda Banken of EUR 11,4 million.

All amount in ' 000 SEK RAL Diagnostics
Compensation transferred
Cash and cash equivalents 261 378
Total tranferred compensation 261 378

Acquisition-related expenses are estimated to amount to SEK 3.0 million during the fourth quarter and will be reported as administration expenses in the consolidated income statement.

Acquired net assets as of the date of acquisition have not yet been determined as their valuation at the time of submission of this report has not yet been completed.

All amount in ' 000 SEK RAL Diagnostics
Estimated net cash flow at
acquisition
Cash paid compensation 261 378
Acquired cash and cash equiva -21 233
lents
Net cash flow 240 145

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 non-controlling 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

KSEK Jul-Sep 2019 Jul-Sep 2018 Jan-Sep 2019 Jan-Sep 2018 Jan-Dec 2018
Profit/loss for the period 17,171 16,800 74,787 59,141 88,688
Number of shares 23,851,547 23,851,547 23,851,547 23,851,547 23,851,547
Net earnings per share 0.72 0.70 3.14 2.48 3.72

Equity per share

KSEK Jul-Sep 2019 Jul-Sep 2018 Jan-Sep 2019 Jan-Sep 2018 Jan-Dec 2018
Equity 326,956 258,840 326,956 258,840 290,375
Number of shares 23,851,547 23,851,547 23,851,547 23,851,547 23,851,547
Equity per share 13.71 10.85 13.71 10.85 12.17

Equity-asset ratio

KSEK Jul-Sep 2019 Jul-Sep 2018 Jan-Sep 2019 Jan-Sep 2018 Jan-Dec 2018
Equity 326,956 258,840 326,956 258,840 290,375
Balance sheet total 437,483 329,036 437,483 329,036 372,782
Equity ratio 74.7% 78.7% 74.7% 78.7% 77.9%

Gross margin

KSEK Jul-Sep 2019 Jul-Sep 2018 Jan-Sep 2019 Jan-Sep 2018 Jan-Dec 2018
Net sales 95,599 84,337 311,938 253,847 364,812
Gross profit 72,754 62,207 236,875 188,911 270,866
Gross margin 76.1% 73.8% 75.9% 74.4% 74.2%

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

Operating margin

KSEK Jul-Sep 2019 Jul-Sep 2018 Jan-Sep 2019 Jan-Sep 2018 Jan-Dec 2018
Net sales 95,599 84,337 311,938 253,847 364,812
Operating profit 21,870 21,024 94,751 75,782 111,607
Operating margin 22.9% 24.9% 30.4% 29.9% 30.6%

EBITDA

KSEK Jul-Sep 2019 Jul-Sep 2018 Jan-Sep 2019 Jan-Sep 2018 Jan-Dec 2018
Operating profit 21,870 21,024 94,751 75,782 111,607
Depreciation 3,772 1,466 10,469 5,322 6,807
EBITDA 25,642 22,490 105,220 81,104 118,414

Net sales

Jul-Sep 2019 Jul-Sep 2019 Jul-Sep 2018 Jul-Sep 2018
KSEK (%) MSEK (%) MSEK
Last period 84,337 61,348
Organic growth 8% 6,747 33% 20,545
Currency effect 5% 4,515 4% 2,443
Current period 13% 95,599 37% 84,337

Review Report

To the Board of Directors 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, 2019 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.

Emphasis and 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 standards.

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 that is expressed on the basis of a review does not give the same level of assurance as a conclusion based on an audit.

Conclusion

Based on our review, nothing has come to our attention that causes us to believe that the accompanying interim report does not, in all material respects, accord with IAS 34 and the Annual Accounts Act and, for the parent company, with the Annual Accounts Act.

Lund, October 23, 2019

Deloitte AB

Maria Ekelund Authorized public accountant

This is CellaVision

Vision

Our vision is global digitization and automation of blood analyses for both the human and veterinary segments. Our method contributes to improved patient diagnostics, streamlining and reduced healthcare costs.

Business concept

CellaVision develops and sells digital solutions for medical microscopy. We replace manual microscopes with analyzers based on digital image analysis technology, artificial intelligence and IT. Our systems contribute to more effective workflows and higher quality in laboratory medicine, an important part of the health care sector.

CellaVision´s core activities

CellaVision's core activities are digital image analysis of blood and other body fluids. Innovation is an important part of CellaVision's mission and its employees are the company's main resource. The company's coordinated competence transforms customers' needs into effective solutions for healthcare services.

CellaVision's employees have a high level of education and sound experience of the biomedical sector. Our employees' broad competence in product development, quality assurance, market establishment and market support is crucial to the company's development. The company has core technological expertise in image analysis, artificial intelligence and automated microscopy.

Company culture

CellaVision's corporate culture is characterized by understanding of the customer, quality awareness and ability to take action with responsibility, which is reflected in CellaVision's value-creating core values: Customer in focus, Initiative and Responsibility and Simplicity and Quality. Along with objectives, vision and guidelines, the core values inform the daily work and form a profitable corporate culture.

Offer to end customers

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

Strategic partnerships

CellaVision collaborates with strategic partners in order to gain scalability in manufacturing and sales.

Suppliers

CellaVision's analyzers are manufactured in Sweden by contract manufacturers. The company has direct agreements with selected sub-contractors for key components.

Distribution via suppliers of cell counters

CellaVision's solution is 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 cost effectively. CellaVision 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

Our 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

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

• Operating margin >20 % The operating margin is to exceed 20 percent over an economic cycle

CellaVision completed the acquisition of RAL Diagnostics (RAL) on October 1, 2019

On October 1, CellaVision AB acquired the French company RAL Diagnostics (RAL), which manufactures sample preparation products in hematology, pathology, cytology and microbiology.

RAL´s reagents enhance the identifcation of cell and tissue morphology, parasites and bacteria necessary to diagnose many illnesses. RAL supplies innovative products and solutions for standardized laboratory diagnostics and improved performance for cellular image processing. The company in Bordeaux, in France, includes a production facility with current annual production of reagents.

The acquisition of RAL gives CellaVision the ability to further improve the quality of sample preparation, which is of great importance for the result of the blood analysis. The quality of the sample preparation is important for optimal functioning of CellaVision's systems, and there is a great need in both large, small and mid-size laboratories for standardized solutions.

CellaVision's and RAL's products are used together by several laboratories and constitute separate but interdependent steps in a complete blood analysis chain. CellaVision and RAL together create an increased customer value in digital morphology by offering a complete and integrated solution for the hematology laboratory.

In addition to RAL's offering in hematology, a segment amounting to 50 percent, RAL's product portfolio includes the areas of microbiology, amounting to 40 percent, and cytology and pathology which together amount to ten percent. The acquisition thus opens new future opportunities to apply CellaVision's technology beyond hematology.

Questions concerning the report can be addressed to:

Zlatko Rihter, VD Tel: +46 46 460 16 71 [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 8:20 a.m. CET on October 23, 2019.

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
Year-end bulletin 2019 5 February 2020
Interim Report January-March 22 April
Annual General meting 23 April
Interim Report January-June 16 July
Interim Report January- September 23 October
Year-end bulletin 2020 29 January 2021

CellaVision in the world

HEAD OFFICE SWEDEN

CellaVision AB (publ) Mobilvägen 12 22362 Lund Established 1998

Visiting address: Mobilvägen 12 Tel: +46 46 460 16 00 www.cellavision.se Org.nr. 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

With the 17 organizations for local market support CellaVision has direct presence more than 30 countries.