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CellaVision Interim / Quarterly Report 2010

Oct 27, 2010

3025_10-q_2010-10-27_4417d9d6-1c08-4280-9f1d-cbbfaca417e7.pdf

Interim / Quarterly Report

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CELLAVISION AB (publ) Interim report for the period January 1 – September 30, 2010

Sales increased by 29 % during the period

January – September

  • Net sales for period increased by 29 % to SEK 89.8 million (69.7).
  • The Group's operating result for the period was SEK 4.9 million (7.3).
  • The result after tax was SEK 1.2 million (6.8).
  • Earnings per share for the period were SEK 0,05 (0.28).
  • Cash and cash equivalents amounted to SEK 30.8 million (11.9) at the close of the period.

July – September

  • In the third quarter sales increased by 19 % to SEK 32.0 million (27.0).
  • The operating result for the third quarter was SEK 2.2 million (5.5).
  • The result after tax was SEK -2.1 million (5.4).
  • Earnings per share for the third quarter were SEK -0.09 (0.22).
(SEK
million)
Jul–Sep
2010
Jul–Sep
2009
Jan–Sep
2010
Jan–Sep
2009
Full year
2009
Net sales 32.0 27.0 89.8 69.7 109.0
Gross profit 17.9 20.1 58.7 51.0 76.5
Operating result 2.2 5.5 4.9 7.3 14.8
Result before tax -2.1 5.4 1.2 6.8 14.2
Cash flow 5.7 2.6 8.8 -7.7 2.3

CellaVision in brief

CEO's comments: Demand greater than ever

Demand for our products is greater than ever. Consequently our great challenge now is to adapt production and organization to the strong growth in demand. In the third quarter we have had a shortage of a small number of components and production disruptions for our DM1200 analyzer. Ongoing measures are intended to prevent sales being affected.

Now as we pass the year's three-quarter mark we can report a sales increase of 29 % to SEK 90 million, which exceeds our long-term growth target of 15 % over an economic cycle. Our American distributors' initiatives in the US are now apparent in the sales figures and in the third quarter the North American share of sales was as much as 51 %. We are also now starting to see good sales results from our distributors in Asia, mainly in Japan and China.

CellaVision is growing with profitability but fluctuations in the dollar impacted our earnings in the quarter. At the same time as we see strong upturn in sales, the general economic recovery in the US is still weak and the dollar has fallen sharply in value during the period. The growing demand for our products has also meant that since last spring we have invested in our own organization with six new employees in product and technology development.

For further information, please contact:

Yvonne Mårtensson, CEO Phone: +46 708 33 77 82, email: [email protected] Johan Wennerholm, CFO Phone: +46 708 33 81 68, email: [email protected]

CELLAVISION IN BRIEF

CellaVision AB develops, markets and sells market leading image analysis based systems for routine analysis of blood and body fluids. The company's core competence is development of software and hardware for automatic image analysis of cells and cell changes for applications in healthcare. These analyses often constitute critical reference data for fast and correct diagnosis of illnesses. The company has leading-edge expertise in digital image analysis, artificial intelligence and automated microscopy.

The CellaVision DM product family comprises a system for automated analysis of blood cells in smears of peripheral blood and body fluids. The products help to streamline and standardize analysis and increase interchange of skills within and between laboratories.

CellaVision's customers are large and mid-sized hospital laboratories and commercial laboratories, mainly in Europe and North America. In most countries sales are through distributors. Products are sold directly in the Nordic countries and via subsidiaries in the US, Canada and Japan.

OVERVIEW OF THE PERIOD JANUARY – SEPTEMBER

Market and sales

Sales for the entire period increased by 29% to SEK 89.8 million compared with SEK 69.7 million in the corresponding period of the previous year. Adjusted for exchange rate effects, the increase was 40%. The breakdown of sales is: 44% (48) Europe, 46% (49) North America and 10% (3) rest of the world.

Sales for the third quarter increased by 19 % to SEK 32.0 million (27.0) compared with the previous year. Adjusted for exchange rate effects, the increase was 32%. In the third quarter Europe accounted for 39% (83) of sales, North America for 51% (15) and the rest of the world for 10% (2).

Like others in the medical devices industry selling capital equipment, CellaVision's inflow of orders is unevenly distributed over the year, depending on the distributors' sales and inventory levels. Consequently, variations in order volume in individual quarters may be great in the different geographical markets. Recent trends indicate, however, a higher long-term level of demand for CellaVision's products. Since April the company has increased its workforce with six employees in product and technology development at its head office in Lund.

What is driving growth?

CellaVision's growth is linked to forces operating in the health and medical care market. Health and medical care is exposed to heavy cost pressure and the growing staff shortages that exist in laboratory operations make CellaVision's automated products a highly interesting solution. In the third quarter the customer base continued to grow and CellaVision now has customers in more than 40 countries all over the world. The new distribution strategy contributes to the quarter's healthy sales performance, especially in the US, but also in Europe and Asia through Sysmex sales initiatives.

CellaVision's product offer

Analyzers: CellaVision® DM8 CellaVision® DM96 CellaVision® DM1200

Optional application for body fluid analysis: CellaVision® Body Fluid Application

Software for networking and remote access: CellaVision® Remote Review Software

Software for proficiency testing and education: CellaVision® Competency Software

Development in Europe

The European customers continues to show great interest in CellaVision's products and are replacing manual microscopy with CellaVision's digital method in order to provide against the shortage of competence that the large-scale retirement of Medical Technologists in coming years is expected to create. During the quarter above all the company's instrument for large laboratories, CellaVision DM96, has been ordered by Sysmex Europe.

Development in North America

Cooperation between CellaVision's own sales organization in the US and both the American distributors - Beckman Coulter and Sysmex America – continues to go well. Beckman Coulter and CellaVision increased their joint activities in the market during the period and as a result Beckman Coulter could install the first instruments at the end customer. Interest for "lab automation" is great in the entire North American market and through its new distribution strategy in the USA CellaVision is successfully reaching out with its products to a greater part of the market. Staring on October 1 CellaVision's American subsidiary entered into a cooperation agreement with the instrument company Abbott aimed at identifying potential direct sales customers.

In July the new instrument CellaVision DM1200 was positively received by an international audience at the AACC Annual Meeting & Clinical Lab Expo in California, where the product was presented both by CellaVision and the distributor Sysmex America.

Sysmex America successfully markets automation concepts and during the quarter broadened its product portfolio with an image analysis based instrument from the supplier Medica for laboratories with lower automation requirements. The growth of new digital analyzers is a sign that CellaVision has opened a market segment proving to be attractive to other companies as well.

In Canada the laboratories show particularly great interest in CellaVision's solution for remote access, since the geographical distances between hospitals is often great. A hospital group in the Toronto area bought its third CellaVision instrument during the quarter and with the help of CellaVision's technology is able to coordinate procedures and standardize test results online, thereby reducing consultation times between the different laboratories.

Development in Japan

Increased sales in Asia are due among other things to further instruments being sold to the Japanese distributor Sysmex, which has now started to install products at end customers. CellaVision's products fit well into the Japanese laboratory market where the need for automation and streamlining is very great. Japan has a substantially increasing elderly population with high health and medical care requirements. The Japanese market for laboratory equipment is one of the world's largest and most demanding. Using parallel sales channels – our own sales organization together with Sysmex – knowledge of and interest for CellaVision's products is rapidly increasing in the Japanese market. Cooperation with Sysmex, with its home market and over 50 % market share in Japan, started on April 1 this year, when the companies entered into a non-exclusive global sales and distribution agreement.

Asia and Oceania

CellaVision products are also appreciated in Asia and Oceania for their potential for time-saving and quality assurance and the interest is of central importance for the quarter's inflow of orders. The efforts of the distributor Sysmex in the region has brought results in the form of orders for hospitals in China and Thailand, for example. In Hong Kong the distributor Vastec has won further orders.

Research and development

The optional application for body fluids for the CellaVision DM1200 became commercially available earlier this year for customers in the European market. In September CellaVision submitted an application to the American Food and Drug Administration (FDA) to sell the application in the USA. The company is also preparing to register the product in Canada. The body fluid application is already available for the CellaVision DM96 in all the company's main markets.

The two pre-studies on malaria and bone marrow that started in spring 2010 with the help of development grants from the Swedish Governmental Agency for Innovation Systems Vinnova and the Swedish Agency for Economic and Regional Growth/Skåne Regional Council continued in the third quarter. These grants have made it possible for CellaVision to determine whether the company's technology can also be used to detect blood cells infected by the malaria parasite or can be used to analyze blood cells in bone marrow. The pre-studies include interview data from about twenty hospitals in Europe, North America and Japan and they are expected to be completed as scheduled in late 2010.

During the period CellaVision started a software project to evaluate the technical conditions for a veterinary application of CellaVision's image analysis concept. The project is based on the results of the evaluation of the company's test application made by veterinary laboratories in Sweden and the USA. It is expected to have a final basis for a decision during the first half of 2011.

The company estimates that capitalized expenditure for new development will be between SEK 5 and 6 million in the 2010 financial year.

At the close of the period CellaVision had a patent portfolio containing a total of 18 patented inventions, which have generated 30 patents to date.

Significant events after the period close

There are no significant events to report.

SALES, EARNINGS AND INVESTMENT

Net sales for the Group were SEK 89.8 million (69.6) for the period 1 January–30 September, an increase of 29 % compared with the same period in the previous year. Net sales in the third quarter were SEK 32.0 million (27.0).

The gross margin for the period was 65 % (73) and in the third quarter was 56 % (74). CellaVision usually has large gross margin variations from quarter to quarter. This is dependent on the share of sales via distributors or via CellaVision's own sales companies, the product mix sold and exchange rates. The lower margin of the third quarter is due to negative foreign exchange effects and to the fact that the larger percentage of sales were via distributors. It was also impacted by the production disruptions mentioned, with a shortage of components for the CellaVision DM1200.

The Group's operating result for the period was SEK 4.9 million (7.3). With last year's average exchange rate the operating result for the period would have been SEK 12.2 million. The Group's operating result for the third quarter was SEK 2.2 million (5.5). Total operating expenses for the period were SEK 54.2 million (43.7), of which in the third quarter SEK 15.7 million (14.6). Operating expenses have increased because CellaVision grew during the period and the organization now includes more employees in important areas of competency.

Capitalized expenditure for development projects was SEK 2.4 million (10.6) during the period, of which in the third quarter SEK 1.6 million (2.7). The share of R&D costs that can be capitalized has fallen during the period and a larger share was expensed compared with last year when the new hardware platform was being developed. Investments in property, plant and equipment during the quarter amounted to SEK 0.0 million (0.1).

FINANCING

The funds at the Group's disposal at period close consisted of SEK 45.8 million, SEK 15.0 million of which is unutilized credit.

The total cash flow for the period was SEK 8.8 million (-7.7). The cash flow from operating activities for the third quarter was SEK -1.0 million (0.1).

To obtain a stable picture of earnings the company continuously hedges 50-75 per cent of currency exposure in net flows 12 months forward. In the third quarter earnings for the period were impacted by unrealized exchange rate differences in the parent company's receivables from the group companies of 3.0 MSEK.

PARENT COMPANY

Parent company sales for the period were SEK 81.4 million (67.3). The result before tax was SEK 7.8 million (18.4). Parent company sales for the third quarter were SEK 25.9 million (21.4). The result before tax for the quarter was SEK -1.8 million (6.3).

The parent company's gross investment in property, plant and equipment during the period amounted to SEK 0.1 million (0.3) and gross investment in intangible assets amounted to SEK 2.4 million (10.6). The net cash flow was SEK 8.8 million (-7.0).

In other respects please refer to the information for the Group.

PERSONNEL

The number of employees of the Group, restated as full-time positions, was 56 (50) at the close of the period. Of these, 39 (31) were men and 17 (19) women. In order to meet the higher level of demand during the period six new people were employed in product and technology development.

OTHER INFORMATION

Group

On September 30, 2010 the Group consisted of the parent company and the whollyowned subsidiaries CellaVision Inc. (USA), CellaVision Canada Inc. (Canada), CellaVision Japan K.K. (Japan) and CellaVision International AB.

Accounting policies

The consolidated accounts are prepared in accordance with International Financial Reporting Standards, IFRS. The interim report for the Group was prepared in accordance with IAS 34, Interim Financial Reporting, the Annual Accounts Act and in accordance with the Stockholm Stock Exchange rules and regulations for companies listed on Nasdaq OMX Stockholm. The interim report for the parent company was prepared in accordance with the Annual Accounts Act and the Swedish Financial Reporting Board recommendation RFR 2.3, Accounting for Legal Entities. The interim report has been prepared in accordance with the accounting policies and valuation methods presented in the Annual Report for 2009. New standards and interpretations that came into force on January 1, 2010 have not had any impact on CellaVision's financial reporting for the interim report period.

The Nomination Committee before the Annual General Meeting 2011

According to a resolution by the 2010 Annual General Meeting the Nomination Committee shall consist of the Chairman of the Board and one representative for each of the three largest shareholders in terms of voting power at the end of September 2010. Before the Annual General Meeting in 2011 the Nomination Committee consists of the Chairman of the Board Lars Gatenbeck, Lennart Hansson, chairman (Stiftelsen Industrifonden), Anders Frick (Metallica Förvaltnings AB) and Christer Fåhraeus (Christer Fåhraeus including companies).

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 and sensitivity analysis in the Annual Report for 2009.

Financial calendar

Year-end bulletin 2010 February 15, 2011
Interim Report Jan – March 2011 April 20, 2011
Annual General Meeting 2011 April 26, 2011

The interim reports are available at www.cellavision.com.

The Board of Directors and CEO 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 27, 2010

Lars Gatenbeck Chairman of the Board

Niels Freiesleben Christer Fåhraeus Sven-Åke Henningsson

Torbjörn Kronander Anna Malm Bernsten Yvonne Mårtensson Member of the Board Member of the Board President and CEO

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

For further information, please contact:

Yvonne Mårtensson, CEO, CellaVision AB Phone: 0708 33 77 82. Email: [email protected] Johan Wennerholm, CFO, CellaVision AB Phone: 0708 33 81 68. Email: [email protected]

Address

CellaVision AB (publ) • Ideon Science Park • SE 223 70 Lund • Phone: CellaVision's website: www.cellavision.com, corporate identity number: 556500-0998 CellaVision is listed on the Nasdaq OMX Stockholm, Small Cap list. The company is traded under the ticker symbol CEVI and ISIN code SE0000683484.

Publication: The information in this interim report is disclosed by CellaVision AB (publ) pursuant to the Securities Market Act and/or the Financial Instruments Trading Act. The information was released for public disclosure on October 27, 2010 at 08.30.

REVIEW REPORT

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

Introduction

We have performed review of the interim report for CellaVision AB (publ.) as at September 30, 2010 and the nine-month period ending on that date. The Board of Directors and the President/CEO is 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 more limited in scope than an audit that is conducted in accordance with Standards on Auditing in Sweden (RS) 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 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 interim report does not, in all material respects, accord with IAS 34 and the Annual Accounts Act for the Group and, for the parent company, with the Annual Accounts Act.

Lund, October 27, 2010

Deloitte AB

Per-Arne Pettersson Authorized public accountant

Consolidated Income Statement
All amount in ' 000 SEK Jul-Sep 2010 Jul-Sep 2009 Jan-Sep 2010 Jan-Sep 2009 Jan-Dec 2009
Net Sales 31 989 26 993 89 752 69 656 108 974
Cost of goods sold -14 121 -6 927 -31 078 -18 658 -32 486
Gross Profit 17 868 20 066 58 674 50 998 76 488
Sales and Marketing expenses -7 242 -6 341 -24 982 -22 074 -30 443
Administration expense -5 188 -4 812 -16 949 -13 905 -19 285
R&D expenses -3 251 -3 126 -12 248 -7 522 -12 058
Other operating income 0 - 360 - 75
Other operating expenses - -315 - -201 0
Operating result 2 187 5 472 4 855 7 296 14 777
Interest income and financial exchange rate gains 0 0 0 13 15
Interest expense and financial exchange rate losses -4 334 -111 -3 613 -514 -631
Result before income tax -2 147 5 361 1 242 6 795 14 161
Tax
Net result
-
-2 147
-
5 361
-
1 242
-
6 795
13 559
27 720
Statement of Comprehensive Income
All amount in ' 000 SEK Jul-Sep 2010 Jul-Sep 2009 Jan-Sep 2010 Jan-Sep 2009 Jan-Dec 2009
Net profit for the period -2 147 5 361 1 242 6 795 27 720
Other comprehensive income:
a) Financial assets at fair value
Reclassified to operating result -8 -1 341
Revaluation of financial assets 2 820 2160 2 265 2 160 1 434
Income tax relating to financial assets -740 -243 -377
b)Translation difference
Per share data Jul-Sep 2010 Jul-Sep 2009 Jan-Sep 2010 Jan-Sep 2009 Jan-Dec 2009
Earnings per share, SEK */ -0,09 0,22 0,05 0,28 1,16
Equity per share SEK 3,24 2,36 3,24 2,36 3,14
Equity ratio, % 63% 62% 63% 62% 66%
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 12,10 9,55 12,10 9,55 10,00

Translation difference in the group 1 725 205 581 1 274 37 Sum of other comprehensive income: 3 797 2 365 1 262 3 434 1 094 Comprehensive result for the period 1 650 7 726 2 504 10 229 28 814

*/ In relation to net profit and average outstanding shares

Quarterly results
All amount in ' 000 SEK Q3 2010 Q2 2010 Q1 2010 Q4 2009 Q3 2009 Q2 2009
Net Sales 31 989 36 640 21 123 39 318 26 993 20 704
Gross Profit 17 868 26 782 14 024 25 490 20 065 16 814
Gross Margin in % 56 73 66 65 74 81
Overhead cost -15 681 -19 677 -18 461 -18 009 -14 594 -15 855
Operating result 2 187 7 105 -4 437 7 481 5 472 959
Net result -2 147 8 126 -4 737 20 925 5 361 916
Cashflow 5 651 7 108 -3 964 10 042 2 578 -5 116

Consolidated Balance sheet

All amount in ' 000 SEK 2010-09-30 2009-09-30 2010-06-30 2009-12-31
Assets
Intangible assets 21 439 24 375 21 137 23 004
Tangible assets 1 729 2 460 1 869 2 270
Financial assets 25 688 12 083 25 701 25 638
Inventory 7 248 10 040 11 961 9 091
Trade receivables 27 920 21 611 19 258 25 493
Other receivables 7 311 8 280 5 288 5 892
Cash and bank 30 759 11 922 25 108 21 964
Total assets 122 095 90 772 110 323 113 352
Equity and liabilities
Equity 77 303 56 214 75 653 74 799
Short term debt 12 015 7 401 13 249 9 361
Short term debt with interest 18 059 16 163 9 719 13 661
Trade payables 12 606 9 182 9 722 13 791
Other liabilities 2 112 1 812 1 980 1 740
Total equity and liabilities 122 095 90 772 110 323 113 352
Consolidated statement of changes in equity 2010-09-30 2009-09-30 2010-06-30 2009-12-31
Balance at the beginning of the year 74 799 45 985 74 799 45 985
Net profit for the year 2 504 10 229 854 28 814
Balance at the end of the year 77 303 56 214 75 653 74 799
Cash flow analysis
All amount in ' 000 SEK Jul-Sep 2010 Jul-Sep 2009 Jan-Sep 2010 Jan-Sep 2009 Jan-Dec 2009
Result before taxes -2 147 5 361 1 242 6 795 14 161
Adjustment for items not included in cash flow 9 738 -2 571 8 327 -3 842 711
Taxes - - - - -
Cash flow from operations before changes in
working capital 7 591 2 790 9 569 2 954 14 872
Changes in working capital -8 594 -2 734 -2 643 4 577 5 708
Cash flow from operations -1 003 56 6 926 7 531 20 580
Capitalisation of development costs -1 629 -2 658 -2 415 -10 648 -10 648
Aquisitions in financial non-current assets -38 - -64 0 -
Aquisitions in tangible non-current assets -19 -128 -50 -366 -466
Cash flow from investment activities -1 686 -2 786 -2 529 -11 014 -11 114
New loans and instalments of dept 8 340 5 308 4 398 -4 232 -7 140
Cash flow from financing activities 8 340 5 308 4 398 -4 232 -7 140
Total cash flow 5 651 2 578 8 795 -7 716 2 326
Liquid funds at beginning of period 25 108 9 344 21 964 19 638 19 638
Liquid funds at end of period 30 759 11 922 30 759 11 922 21 964
Income Statement - Parent Company
All amount in ' 000 SEK Jul-Sep 2010 Jul-Sep 2009 Jan-Sep 2010 Jan-Sep 2009 Jan-Dec 2009
Net Sales 25 924 21 367 81 402 67 260 99 290
Cost of goods sold -12 609 -6 155 -32 481 -19 910 -31 970
Gross Profit 13 315 15 212 48 921 47 350 67 320
Sales and Marketing expenses -2 438 -553 -8 744 -6 899 -10 065
Administration expense -5 188 -4 812 -16 949 -13 905 -19 285
R&D expenses -3 251 -3 126 -12 248 -7 522 -12 057
Other operating income 0 - 360 - 75
Other operating expenses 0 -315 0 -201 0
Operating result 2 438 6 406 11 340 18 823 25 988
Interest income and financial exchange rate gains 0 0 0 13 14
Interest expense and financial exchange rate losses -4 284 -107 -3 534 -420 -534
Result before income tax
Tax
-1 846 6 299 7 806 18 416 25 468
13 000
Net result -1 846 6 299 7 806 18 416 38 468
Statement of Comprehensive Income
All amount in ' 000 SEK
Jul-Sep 2010 Jul-Sep 2009 Jan-Sep 2010 Jan-Sep 2009 Jan-Dec 2009
Net result for the period -1 846 6 299 7 806 18 416 38 468
Other comprehensive income: - - - - -
Sum of other comprehensive income: 0 0 0 0 0
Comprehensive result for the period -1 846 6 299 7 806 18 416 38 468
Balance sheet - Parent Company
All amount in ' 000 SEK 2010-09-30 2009-09-30 2010-06-30 2009-12-31
Assets
Intangible assets 21 439 24 375 21 137 23 004
Tangible assets 1 604 2 297 1 738 2 114
Financial assets 25 704 12 704 25 704 25 704
Inventory 4 454 6 655 5 385 6 073
Trade receivables 21 126 17 918 14 177 13 517
Receivables from group companies 32 586 18 337 37 049 29 859
Other receivables 5 149 4 778 5 179 4 463
Cash and bank 26 091 10 127 16 969 17 252
Total assets 138 153 97 191 127 338 121 986
Equity and liabilities
Equity 92 881 65 023 94 727 85 073
Short term debt 9 755 5 414 11 222 7 905
Short term debt with interest 18 059 16 163 9 719 13 661
Liabilities to group companies 2 815 - 146 144
Trade payables 12 531 8 779 9 544 13 463
Other liabilities 2 112 1 812 1 980 1 740
Total equity and liabilities 138 153 97 191 127 338 121 986