SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
FORM 6-K
REPORT OF FOREIGN ISSUER
Pursuant to Rule 13a-16 or 15d-16 of
the Securities Exchange Act of 1934
Date of Report: November 2, 2000
BIORA AB
SE-205 12 Malmo, Sweden
Telephone: (011) 46-40-32-13-33
Indicate by a check mark whether the registrant files or
will file annual reports under cover of Form 20-F or Form 40-F.
|X| Form 20-F |_| Form 40-F
Indicate by check mark whether the registrant by furnishing
the information contained in this Form is also thereby furnishing the
information to the Commission pursuant to Rule 12g3-2(b) under the
Securities Exchange Act of 1934.
|_| Yes |X| No
If "Yes" is marked, indicate below the file number assigned
to the registrant in connection with Rule 12g3-2(b):
Not applicable.
This Form 6-K consists of the third quarter interim report
of Biora AB for the period ended September 30, 2000, which was issued on
November 2, 2000.
Pursuant to the requirements of the Securities Exchange Act of
1934, the Registrant has duly caused this report to be signed on its behalf
by the undersigned hereunto duly authorized.
BIORA AB
Dated: November 30, 2000 By: /s/ Anders Agering
-----------------------------
Anders Agering
Chief Financial Officer
BIORA
INTERIM REPORT FOR THE FIRST NINE MONTHS 2000
9 MONTHS 9 Months Full Year
2000 1999 1999
Net Sales, SEK millions 66.4 52.2 73.6
Operating loss, SEK millions -54.3 -64.8 -91.8
Net loss, SEK millions -52.1 -60.7 -86.7
o
Sales from January through September increased by 27% to 66.4
million SEK compared to 52.2 for the comparable period in
1999.
o
Sales during the third quarter increased by 55% to
22.8 million SEK, compared to 14.7 in 1999.
o
The greatest increase in sales was in the U.S. market.
o
Focus on dental products.
o
Biora intends to sell or find a partner for Biora
BioEx.
INTERIM REPORT FOR THE FIRST NINE MONTHS 2000
BIORA'S STRATEGY
FOCUS ON INDICATIONS IN THE ORAL CAVITY BIORA'S STRATEGY
Biora's Board of Directors has determined to focus Biora's core business on
development, manufacturing and marketing of pharmaceutical products to
dentists and dental hygienists. Research and development will concentrate
on dental indications that expand the use of Emdogain and that can be
introduced to the market within a near time frame. As a step in
concentrating the operation, it is the company's intention to sell or find
a partner for the BioEx part of the R&D portfolio.
Biora will focus and systematize its marketing and sales to
prioritized markets: the U.S., Germany and Japan. The strategy is to
establish Emdogain as the standard treatment among already existing
customers in these markets.
THE FIRST NINE MONTHS
INCREASED SALES
The group's sales during the first nine months of 2000 equaled SEK 66.4
million compared to SEK 52.2 million during the corresponding period of
1999, an increase of 27%. Excluding foreign exchange fluctuations, sales
increased by 25%. During the third quarter sales increased by 55% to SEK
22.8 million as compared to SEK 14.7 million during the same period in
1999. The greatest sales increase occurred in the U.S. market.
BIORA'S PRINCIPAL MARKETS - THE U.S., GERMANY AND JAPAN
THE U.S. MARKET
The U.S. is Biora's largest single market and is responsible for Biora's
largest increase in sales in terms of dollar. During the first nine months
of the year, sales increased by 60% compared to the preceding year. During
the third quarter the increase was 70%.
Before the summer 2000 Biora received a so-called "approvable letter"
from the United States Food and Drug Administration (FDA) for marketing
EmdogainGel in the U.S. market, but is still waiting for the FDA's formal
approval.
THE GERMAN MARKET
Sales in the German market decreased by 21 percent during the year's first
nine months compared to the same period of the preceding year. During the
third quarter the sales decrease was 17% compared to the same period of
1999.
The process of changing the German marketing company is continuing. A
new organization is in place since October 1.
In September the German Periodontology Association (DGP) supported
the use of Emdogain in the following official statement:
"The evidence of histological and controlled clinical studies shows
that the use of enamel matrix proteins, applied to a clean root surface
during flap surgery, is an effective and reliable regenerative method for
the treatment of vertical periodontal bone defects." The statement is
particularly important for dentists to accept Emdogain as a standard
treatment. Biora has also initiated collaboration with the German
Periodontology Association with the goal of increasing the knowledge of
periodontal disease among dentists. For example, Biora and DGP cosponsor
courses and conferences where dentists can exchange experiences with modern
treatment of periodontal disease.
THE JAPANESE MARKET
Biora's deliveries to the Japanese distributor during the first nine months
of the year increased by 43% compared with the same period 1999. An order
of SEK 3 million was delivered during the third quarter of this year,
compared to SEK 0 million during the corresponding period in 1999. Sales to
the Japanese distributor occur in larger orders and quarter-to-quarter
comparisons can therefore be less meaningful.
OTHER MARKETS
Sales in other markets (outside of the U.S., Germany and Japan) have
increased by 26% during the first nine months and by 30% during the third
quarter compared to the same period in 1999.
FINANCIAL INFORMATION
NET SALES
The Group's net sales during the period increased to SEK 66.4 million
(1999: SEK 52.2 million). The greatest increase occurred in the U.S.
PROFIT/LOSS
Gross profit amounted to SEK 51.3 million (1999: SEK 40.6 million). The
improvement can be explained mainly by the increase in sales.
The operating loss amounted to SEK 54.3 million (1999: loss SEK 64.8
million). Restructuring of the European marketing organization has
contributed to lower selling expenses while total sales increased by 27%.
The increase in administrative costs depends among other things on the
severance compensation to the former CEO.
Net financial items were SEK 2.2 million (1999: SEK 4.2 million). The
decrease is because Biora has had less liquid assets, and therefore lower
interest income, during 2000 than in 1999.
Net loss after tax during the first nine months amounted to SEK 52.1
million (1999: loss SEK 60.7 million), corresponding to a loss per share of
SEK 2.46 (1999: loss SEK 2.86) based on a total of 21,203,800 shares.
INVESTMENTS
Capital expenditures for tangible long term assets and patents during the
period totaled SEK 4.1 million (1999: SEK 2.7 million).
FINANCIAL POSITION
Net change in cash and cash equivalents during the period was negative, in
an amount of SEK 46.5 million (1999: negative SEK 59.5 million). At the end
of the report period (figures for December 31, 1999, are given below in
parentheses for comparison), the Group's liquid funds amounted to SEK 66.3
million (SEK 112.8 million), the equity/assets ratio was 66.3 percent
(78.3) and Group equity amounted to SEK 75.3 million (SEK 127.4 million).
EMPLOYEES
The number of employees in the Group at the end of the report period was
79, compared to 92 employees as of December 31, 1999. Some positions will
be filled in the near future.
COMING FINANCIAL INFORMATION
During 2001, Biora will publish financial information on the following
dates:
o Year end report on 2000 operations February 8
o Annual Report End of March
o Interim report January - March May 3
o Shareholder's meeting May 3
o Interim report January - June August 23
o Interim report January - September November 7
Malmo, November 2, 2000
Richard Soderberg
President and CEO
Biora's auditors have not audited this interim report.
This report may contain certain forward-looking statements that relate to
future events or future business and financial performance. Such statements
can only be predictions and the actual events or results may differ from
those discussed. The Company cautions that these statements are subject to
important factors that could cause actual results to differ materially from
those expressed or implied in such forward-looking statements and are more
fully discussed in periodic reports filed with the Securities and Exchange
Commission.
Biora AB has registered the Emdogain(R) and PrefGel(TM) trademarks. In the
present Interim Report, the trademark registration is mentioned here only.
CONSOLIDATED STATEMENTS OF OPERATIONS
<TABLE>
<CAPTION>
(Swedish GAAP, unaudited) 2000 2000 1999 2000 1999 1999
Qtr 1-3 3RD QTR 3rd Qtr QTR 1-3 Qtr 1-3 Full year
(TUSD)1) (TSEK) (TSEK) (TSEK) (TSEK) (TSEK)
<S> <C> <C> <C> <C> <C> <C>
Net sales 7 402 22 789 14 738 66 433 52 230 73 556
-----------------------------------------------------------------------------------------
Costs of goods sold -1 687 -5 002 -3 074 -15 139 -11 659 -15 470
-----------------------------------------------------------------------------------------
GROSS PROFIT 5 715 17 787 11 664 51 294 40 571 58 086
-----------------------------------------------------------------------------------------
Selling expenses -6 341 -17 791 -20 241 -56 907 -64 494 -90 783
-----------------------------------------------------------------------------------------
Administrative expenses -1 970 -4 857 -3 748 -17 685 -12 430 -18 505
-----------------------------------------------------------------------------------------
Research and development
costs -3 452 -9 851 -9 245 -30 978 -29 523 -41 597
-----------------------------------------------------------------------------------------
Other operating income and
expenses 0 -122 2 154 4 1 029 994
-----------------------------------------------------------------------------------------
LOSS FROM OPERATIONS -6 047 -14 834 -19 416 -54 272 -64 847 -91 805
-----------------------------------------------------------------------------------------
Financial net 243 653 988 2 183 4 221 5 220
-----------------------------------------------------------------------------------------
LOSS AFTER FINANCIAL ITEMS -5 804 -14 181 -18 428 -52 089 -60 626 -86 585
-----------------------------------------------------------------------------------------
Income tax - - - - -32 -154
-----------------------------------------------------------------------------------------
LOSS FOR THE PERIOD -5 804 -14 181 -18 428 -52 089 -60 658 -86 739
-----------------------------------------------------------------------------------------
</TABLE>
CONSOLIDATED BALANCE SHEETS
<TABLE>
<CAPTION>
(Swedish GAAP, unaudited) Sep 30 SEP 30 Sep 30 Dec 31
2000 2000 1999 1999
(TUSD)1 (TSEK) (TSEK) (TSEK)
<S> <C> <C> <C> <C>
Intangible long term assets 1 171 10 510 19 911 16 573
--------------------------------------------------------------------------------------
Tangible long term assets 890 7 990 10 768 10 843
--------------------------------------------------------------------------------------
Financial long term assets 280 2 513 2 524 2 534
--------------------------------------------------------------------------------------
TOTAL LONG TERM ASSETS 2 341 21 013 33 203 29 950
--------------------------------------------------------------------------------------
Inventories 703 6 312 4 368 5 175
--------------------------------------------------------------------------------------
Current receivables 2 220 19 921 17 300 14 807
--------------------------------------------------------------------------------------
Bank deposits 5 571 50 000 90 000 90 000
--------------------------------------------------------------------------------------
Cash and bank 1 814 16 283 37 572 22 804
--------------------------------------------------------------------------------------
TOTAL CURRENT ASSETS 10 308 92 516 149 240 132 786
--------------------------------------------------------------------------------------
TOTAL ASSETS 12 649 113 529 182 443 162 736
--------------------------------------------------------------------------------------
Shareholder's equity 8 387 75 276 153 698 127 406
--------------------------------------------------------------------------------------
Provisions 30 270 484 444
--------------------------------------------------------------------------------------
Long term liabilities2),3) 614 5 506 155 5 505
--------------------------------------------------------------------------------------
Current liabilities2),3) 3 619 32 477 28 106 29 381
--------------------------------------------------------------------------------------
TOTAL SHAREHOLDERS' EQUITY AND LIABILITIES 12 649 113 529 182 443 162 736
--------------------------------------------------------------------------------------
</TABLE>
--------
1) Average exchange rate Jan-Sep, 2000, USD 1=8,9571
2) The part of option premiums received, earlier disclosed as current
liability, has been disclosed as long-term liability. The comparative
figures have been adjusted accordingly.
3) Biora did not have any interest bearing liabilities neither on September
30, 1999 nor December 31, 1999.
<TABLE>
<CAPTION>
STATEMENTS OF CASH FLOWS
CONSOLIDATED (TSEK)
(Swedish GAAP, unaudited) 2000 1999 2000 1999 1999
3RD QTR 3rd Qtr QTR 1-3 Qtr 1-3 Full Year
<S> <C> <C> <C> <C> <C>
Loss for the period -14 181 -18 428 -52 089 -60 658 -86 739
---------------------------------------------------------------------------------------
Depreciation and amortization 1 430 1 391 5 207 4 078 5 552
---------------------------------------------------------------------------------------
Change in capitalized research and
development costs -2 629 1 776 7 886 5 328 8 595
---------------------------------------------------------------------------------------
Other adjustments to reconcile net loss
to net cash flows from / used in
operating activities 84 45 -71 122 541
---------------------------------------------------------------------------------------
Change in assets and liabilities -2 776 -2 052 -3 892 -5 357 2 447
---------------------------------------------------------------------------------------
NET CASH USED IN OPERATING ACTIVITIES -12 814 -17 268 -42 959 -56 487 -69 604
---------------------------------------------------------------------------------------
Capital expenditures (tangible assets
and patents) -1 920 -608 -4 066 -2 687 -4 334
---------------------------------------------------------------------------------------
Other investing activities 6 3 6 34 -29
---------------------------------------------------------------------------------------
NET CASH USED IN INVESTING ACTIVITIES -1 914 -605 -4 060 -2 653 -4 363
---------------------------------------------------------------------------------------
NET CASH USED IN FINANCING ACTIVITIES - - - - -
---------------------------------------------------------------------------------------
Effect of exchange rate changes on cash
and cash equivalents 481 -54 498 -336 -277
---------------------------------------------------------------------------------------
NET CHANGE IN CASH AND CASH EQUIVALENTS -14 247 -17 927 -46 521 -59 476 -74 244
---------------------------------------------------------------------------------------
</TABLE>
<TABLE>
<CAPTION>
KEY RATIOS
CONSOLIDATED
(Swedish GAAP, unaudited) 2000 1999 1999 1998 1997
QTR 1-3 Qtr 1-3 Full Year Full Year2) Full Year
<S> <C> <C> <C> <C> <C>
Net sales (TSEK) 66 433 52 230 73 556 50 119 16 499
---------------------------------------------------------------------------------------
Gross margin, %3) 77,2 77,7 79,0 78,3 66,5
---------------------------------------------------------------------------------------
R & D costs (TSEK)4) 30 978 29 523 41 597 39 980 21 207
---------------------------------------------------------------------------------------
Return on capital employed, %1),5) -68,2 -43,9 -50,7 -40,0 -53,2
---------------------------------------------------------------------------------------
Return on equity, %1),6) -68,5 -43,9 -50,8 -40,0 -58,1
---------------------------------------------------------------------------------------
Equity / assets ratio, %7) 66,3 84,2 78,3 86,6 81,9
---------------------------------------------------------------------------------------
Net debt /equity ratio, %8) -88,1 -83,0 -88,5 -87,4 -103,0
---------------------------------------------------------------------------------------
Total equity (TSEK) 75 276 153 698 127 406 218 970 277 935
---------------------------------------------------------------------------------------
Average number of shares outstanding,
(000s) 9) 21 204 21 204 21 204 21 204 20 571
---------------------------------------------------------------------------------------
Equity per share, SEK9) 3,55 7,25 6,01 10,09 13,51
---------------------------------------------------------------------------------------
Loss per share, SEK9) -2,46 -2,86 -4,09 -2,83 -3,66
---------------------------------------------------------------------------------------
Cash flow per share, SEK10) -2,19 -2,80 -3,50 -4,68 13,66
---------------------------------------------------------------------------------------
</TABLE>
1) Return on capital employed and return on equity have been calculated by
multiplying the nine month operating loss and net loss by 1,33 to obtain
comparability to the other presented twelve months key ratios.
2) Return on capital employed and return on equity have been adjusted for the
effect of the nonrecurring revenue from Seikagaku.
3) Gross profit divided by net sales.
4) R&D-costs are shown gross, including capitalized costs. During 2000, as
well as during 1998 and 1999, no costs have been capitalized under the
caption Capitalized R&D costs, why the net and gross costs were equal,
30,978. (2.5% royalty to Astra on sales of Emdogain has been reclassified
to costs of goods sold.)
5) Operating loss plus financial income divided by average total assets (total
assets less non-interest-bearing operating liabilities including deferred
taxes).
6) Net loss divided by a average equity.
7) Shareholders' equity divided by total assets.
8) Interest-bearing liabilities less cash and bank deposits divided by
shareholders' equity.
9) The number of ordinary shares outstanding used in determination of loss
and equity per ordinary share is calculated on a proforma basis by giving
effect to a 25:1 share split and the 3:1 stock dividend completed by the
Company during 1996. The dilution effects of outstanding convertible loans
and options have not been considered when calculating equity, loss and cash
flow per share for the years 1996-2000 as this would reduce the loss per share.
10) Net change in cash and cash equivalents divided by the average number of
shares in accordance with 9).
