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: August 18, 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 second quarter report, dated
August 18, 2000, of Biora AB.
REPORT FOR THE FIRST HALF YEAR 2000
BIORA AB (PUBL)
AUGUST 18, 2000
Half Year Half Year Full Year
2000 1999 1999
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Sales, SEK millions 43.6 37.5 73.6
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Operating loss, SEK millions -39.4 -45.4 -91.8
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Net loss, SEK millions -37.9 -42.2 -86.7
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o Rickard Soderberg new President and CEO.
o Sales during the first half year of 2000 increased by 16 percent to SEK
43.6 million (compared to SEK 37.5 million during the same period in
1999). The increase occurred primarily in the US market.
o Sales during the second quarter 2000 increased by 11 percent to SEK 22.5
million (compared to SEK 20.3 million in 1999).
o Premixed version of Emdogain, Emdogain(R)Gel, for treatment of
periodontal disease, launched in Europe.
o The indication to use Emdogain to replace knocked-out teeth launched in
Europe in June.
o The Swedish Industrial Fund has granted a conditional loan of SEK 15
million for a Bio-Ex project.
Biora develops, manufactures and sells biologically based products
primarily for use in the treatment of diseases of the oral cavity. The
principal product, Emdogain(R), which is approved for sale in Europe, North
America and Japan, regenerates naturally the supporting structure lost by
the tooth due to periodontal disease. Biora's American Depository Shares
are listed on the Nasdaq National Market in the US and Biora's ordinary
shares are listed on the "O-list" of the Stockholm Stock Exchange in
Sweden.
PRESIDENT AND CEO INVESTOR RELATIONS U.S INVESTOR RELATIONS
RICKARD SODERBERG MIKAEL SJOBLOM ELISABETH LAVERS
+46 40 32 13 59 + 46 40 32 13 65 +1 203 977 7797
REPORT FOR THE FIRST HALF YEAR 2000
NEW PRESIDENT AND CEO FOR BIORA AB
The new President and CEO for Biora AB beginning August 14th is Rickard
Soderberg, formerly Vice President of AstraZeneca with responsibility for
marketing and sales in Sweden. The former President and CEO Tomas
Hammargren will continue as a member of the Board of Directors of Biora AB,
focusing on strategic development questions.
INCREASED SALES
Biora's sales during the first half of 2000 increased to SEK 43.6 million,
compared to SEK 37.5 million during the first half of 1999. Sales during
the second quarter of 2000 increased to SEK 22.5 million, compared to SEK
20.3 million during 1999. The increase occurred primarily in the US market.
SALES PER QUARTER 1998, 1999 AND 2000, SEK MILLIONS
[GRAPHIC OMITTED]
MOVING ANNUAL TOTAL PER QUARTER, QTR 3 1998 - QTR 2 2000
[GRAPHIC OMITTED]
CONTINUED SALES INCREASE IN THE US MARKET
The US is Biora's largest single market and sales there increased by 56
percent during the first half of 2000 compared to the same period in 1999.
The total number of customers in the US was 2,900 at the end of the
reporting period (compared to approximately 2,000 at the same time in
1999). Almost 1,600 of them had purchased products more than once (compared
to about 1,000 at mid year 1999).
NEW MANAGEMENT IN GERMANY
Sales in Germany decreased during the period by 23 percent compared to
1999. Measures were taken during the first half of 2000 to improve the
situation. In June Wolfgang Muller, formerly sales manager for Biora GmbH,
was appointed General Manager of the German subsidiary. In Germany more
than 7,100 customers (six months 1999: 6,200) had purchased Emdogain at the
end of the reporting period, and 4600 (six months 1999: 3,200) of them had
purchased more than once.
OTHER MARKETS
In Japan Biora's products are marketed by the Japanese biotechnology
company Seikagaku Corporation. Sales decreased during the period by 26%
compared to the same period in 1999. This is because orders by the
distributor are placed in large batches and can fall in different quarters.
According to Seikagaku there were 1,100 customers at the end of the
reporting period (six months 1999: 990), of whom 530 (six months 1999: 400)
had purchased Emdogain more than once.
Sales in Sweden increased by 23 percent and in Italy by 12 percent.
EMDOGAIN(R)GEL INTRODUCED IN EUROPE
Emdogain has until now been delivered as two components that are mixed by
the dentist. To simplify use, Biora has developed a premixed product,
Emdogain(R)Gel. The European launch of Emdogain(R)Gel commenced in June in
Geneva at Europerio, an international meeting of periodontists. The new
version has also been approved in Canada, and U.S. approval is pending.
BIORA.COM
Biora's new Internet service was introduced at the beginning of the summer.
"biora.com" today contains information about Biora, such as financial
information, the company's products, research and development. The upgrade
enables us to communicate with customers and patients in a cost efficient
manner.
RESEARCH AND DEVELOPMENT
NEW DENTAL INDICATIONS
The indication tooth trauma (knocked-out teeth) has been approved in Europe
and was introduced at an international conference in Oslo in June. For new
dental indications of Emdogain, clinical studies are continuing for
expanded treatment of periodontitis and treatment of recession type
defects.
WOUND HEALING
The use of Emdogain has been shown to be accompanied by quick healing
following surgery in the treatment of periodontitis. Certain
disease-causing bacteria are inhibited by contact with Emdogain and
connective tissue cells in contact with Emdogain produce growth factors
that promote healing. These characteristics open the possibility of
treating hard to heal wounds even outside the mouth, for example bone
wounds. Clinical pilot studies on this type of wound will begin during
2000. After the end of the reporting period Biora received a conditional
loan from The Swedish Industrial Fund. Biora has been granted SEK 15
million for the project "Use of Emdogain for wound healing outside the oral
cavity".
COMPLEMENT TO CANCER TREATMENT (CARCINOMA)
Cell studies show that growth of certain cancer cells (carcinoma) is
inhibited by Emdogain. The discovery is supported by the knowledge of
Emdogain's mechanism of action that Biora has previously reported, that is,
that Emdogain promotes growth of connective tissue cells while certain
epithelial cells experience so-called programmed cell death. Biora has
submitted an application for global patent protection for the discovery.
BONE FORMATION
Biora has found in pilot studies that certain enamel matrix proteins
stimulate locally formation of new bone. The continuing work is intended to
document the effect and to determine future areas for indications. The goal
is to prove that enamel matrix proteins can be as or even more effective
than the growth factors being developed today. The European Commission has
funded a PhD level researcher (a so-called Marie Curie fellowship) for
Biora's bone formation project. However, Biora's previously announced
application for additional funding, made jointly with a number of European
partners, was denied.
DRY MOUTH (XEROSTOMIA)
Biora has acquired the rights to a patent-protected pharmaceutical project
for treating dry mouth. Approximately 15% of all 50 year olds and 40% of
those over 80 suffer from dry mouth. Dry mouth is a common side effect of
many types of medication and radiation treatment. The substance has been
tested with positive results on healthy volunteers and a limited number of
patients with dry mouth.
FINANCIAL INFORMATION
NET SALES
The Group's net sales during the period increased to SEK 43.6 million
(1999: SEK 37.5 million).
PROFIT/LOSS
Gross profit amounted to SEK 33.5 million (1999: SEK 28.9 million). The
improvement can be explained by the increase in sales. The operating loss
amounted to SEK 39.4 million (1999: SEK 45.4 million loss).
During the period the operating expenses have decreased by approximately
two percent, SEK 1.4 million. Restructuring of the European marketing
organization has contributed to lower selling expenses while sales
increased by 16 percent. The increase in the administrative costs during
the second quarter is principally due to severance compensation to the
departing president.
Net financial items were SEK 1.5 million (1999: SEK 3.2 million). The
decrease is explained by decreased interest bearing assets.
Net loss after tax during the period amounted to SEK 37.9 million (1999:
SEK 42.2 million loss), corresponding to a loss per share of SEK 1.79
(1999: SEK 1.99 loss) based on the average of number of shares outstanding.
INVESTMENTS
Capital expenditures for tangible long-term assets and patents during the
period totaled SEK 2.1 million (1999: SEK 2.1 million).
FINANCIAL POSITION
Net change in cash and cash equivalents during the period was negative, in
an amount of SEK 32.3 million (1999: neg. SEK 41.5 million). At the end of
the reporting period (figures for December 31, 1999, for comparison, are
given below in parentheses) the Group's liquid funds amounted to SEK 80.5
million (112.8.million), the equity/assets ratio was 72.0 %(78.3 %) and the
Group equity amounted to SEK 89.3 million (127.4 million).
EMPLOYEES
As of June 30, 2000, Biora had 80 employees, compared to 92 at year-end
1999. A portion of the decrease consists of vacancies that have been filled
after June 30 or will be replaced in the nearest future.
PARENT COMPANY
Sales for the period amounted to SEK 26.0 million (1999: SEK 26.5 million),
and the loss before allocations and taxes was SEK 41.7 million (1999: SEK
37.4 million loss).
Capital expenditures for tangible long-term assets and patents were SEK 1.6
million (1999: SEK 1.0 million). Net change in cash and cash equivalents
during the period was negative, in an amount of SEK 30.9 million (1999:
neg. SEK 45.3 million). At the end of the reporting period (figures for
December 31, 1999, for comparison, are given below in parentheses) the
parent company's liquid funds amounted to SEK 72.7 million (103.6.million),
the equity/assets ratio was 79.9 %(85.8 %) and equity amounted to SEK 103.7
million (145.4 million).
COMING FINANCIAL INFORMATION
Biora will publish financial information on the following dates:
Interim report for the third quarter 2000 November 2
Year end report for 2000 February 8, 2001
Malmo, August 18,2000
Rickard Soderberg, President and CEO
Biora's auditors have not audited this interim report.
This press release may contain certain forward-looking statements that
relate to the 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 implies in such forward looking
statements and are more fully discusses in periodic reports files with the
Securities and Exchange Commission.
<TABLE>
<CAPTION>
CONSOLIDATED STATEMENTS OF OPERATIONS
2000 2000 1999 2000 1999 1999
(Swedish GAAP, unaudited) Half SECOND Second HALF Half Full
year QUARTER quarter YEAR year year
(TUSD)1) (TSEK) (TSEK) (TSEK) (TSEK) (TSEK)
<S> <C> <C> <C> <C> <C> <C>
Net sales 4 972 22 500 20 258 43 644 37 492 73 556
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Costs of goods sold -1 155 -5 152 -4 511 -10 137 -8 585 -15 470
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GROSS PROFIT 3 818 17 348 15 747 33 507 28 907 58 086
====================================================================================================
Selling expenses -4 457 -20 178 -23 543 -39 116 -44 253 -90 783
----------------------------------------------------------------------------------------------------
Administrative expenses -1 461 -8 128 -4 544 -12 828 -8 682 -18 505
----------------------------------------------------------------------------------------------------
Research and development costs -2 407 -10 815 -9 998 -21 127 -20 278 -41 597
----------------------------------------------------------------------------------------------------
Other operating income and expenses 14 22 -335 126 -1 125 994
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LOSS FROM OPERATIONS -4 493 -21 751 -22 673 -39 438 -45 431 -91 805
====================================================================================================
Financial net 174 738 1 298 1 530 3 233 5 220
----------------------------------------------------------------------------------------------------
LOSS AFTER FINANCIAL ITEMS -4 319 -21 013 -21 375 -37 908 -42 198 -86 585
====================================================================================================
Income tax - - - - -32 -154
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LOSS FOR THE PERIOD -4 319 -21 013 -21 375 -37 908 -42 230 -86 739
====================================================================================================
</TABLE>
<TABLE>
<CAPTION>
CONSOLIDATED BALANCE SHEETS
Jun 30, JUN 30, Jun 30, Dec 31,
(Swedish GAAP, unaudited) 2000 2000 1999 1999
(TUSD)1) (TSEK) (TSEK) (TSEK)
<S> <C> <C> <C> <C>
Intangible long term assets 1 406 12 343 21 892 16 573
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Tangible long term assets 933 8 191 11 439 10 843
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Financial long term assets 288 2 530 2 528 2 534
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TOTAL LONG TERM ASSETS 2 628 23 064 35 859 29 950
=====================================================================================
Inventories 611 5 366 4 079 5 175
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Current receivables 1 710 15 007 17 025 14 807
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Bank deposits 7 406 65 000 100 000 90 000
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Cash and bank 1 769 15 530 45 499 22 804
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TOTAL CURRENT ASSETS 11 496 100 903 166 603 132 786
=====================================================================================
TOTAL ASSETS 14 124 123 967 202 462 162 736
=====================================================================================
Shareholders' equity 10 176 89 318 172 774 127 406
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Provisions 30 264 442 444
-------------------------------------------------------------------------------------
Long term liabilities 2), 3) 627 5 506 155 5 505
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Current liabilities 2), 3) 3 290 28 879 29 091 29 381
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Total shareholders' equity and liabilities 14 124 123 967 202 462 162 736
=====================================================================================
</TABLE>
1) Average exchange rate Jan-Jun, 2000, USD 1 = 8,7771
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 June 30,
2000, June 30, 1999 nor December 31, 1999.
<TABLE>
<CAPTION>
STATEMENTS OF CASH FLOWS
CONSOLIDATED (TSEK) 2000 1999 2000 1999 1999
SECOND Second HALF Half Full
(Swedish GAAP, unaudited) QUARTER quarter YEAR year year
<S> <C> <C> <C> <C> <C>
Loss for the period -21 013 -21 375 -37 908 -42 230 -86 739
----------------------------------------------------------------------------------------------
Depreciation and amortization 2 412 1 401 3 777 2 687 5 552
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Change in capitalized research and
development costs 2 629 1 776 5 257 3 552 8 595
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Other adjustments to reconcile net
loss to net cash flows from/used
in operating activities 15 39 -155 77 541
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Change in assets and liabilities 1 343 2 330 -1 116 -3 305 2 447
----------------------------------------------------------------------------------------------
NET CASH USED IN OPERATING ACTIVITIES -14 614 -15 829 -30 145 -39 219 -69 604
==============================================================================================
Capital expenditures (tangible
assets and patents) -559 -946 -2 146 -2 079 -4 334
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Other investing activities - - - 31 -29
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NET CASH USED IN INVESTING ACTIVITIES -559 -946 -2 146 -2 048 -4 363
==============================================================================================
NET CASH USED IN FINANCING ACTIVITIES - - - - -
==============================================================================================
Effect of exchange rate changes
on cash and cash equivalents 91 -44 17 -282 -277
----------------------------------------------------------------------------------------------
NET CHANGE IN CASH AND CASH EQUIVALENTS -15 082 -16 819 -32 274 -41 549 -74 244
==============================================================================================
</TABLE>
<TABLE>
<CAPTION>
KEY RATIOS
CONSOLIDATED 2000 1999 1998 1997 1996
HALF Full Full Full Full
(Swedish GAAP,unaudited) YEAR year year 2) year year
<S> <C> <C> <C> <C> <C>
Net sales (TSEK) 43 644 73 556 50 119 16 499 4 561
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Gross margin, % 3) 768 79,0 78,3 66,5 1,1
------------------------------------------------------------------------------------------
R & D costs (TSEK) 4) 21 127 41 597 39 980 21 207 10 884
------------------------------------------------------------------------------------------
Return on capital employed, % 1), 5) -697 -50,7 -40,0 -53,2 -266,2
------------------------------------------------------------------------------------------
Return on equity,% 1), 6) -700 -50,8 -40,0 -58,1 neg
------------------------------------------------------------------------------------------
Equity / assets ratio, % 7) 720 78,3 86,6 81,9 -34,2
------------------------------------------------------------------------------------------
Net debt / equity ratio, % 8) -902 -88,5 -87,4 -103,0 -84,3
------------------------------------------------------------------------------------------
Total equity (TSEK) 89 318 127 406 213 970 277 935 -18 437
==========================================================================================
Average number of shares
outstanding, (000s) 9) 21 204 21 204 21 204 20 571 14 207
------------------------------------------------------------------------------------------
Equity per share, SEK 9) 421 6,01 10,09 13,51 -1,30
------------------------------------------------------------------------------------------
Loss per share, SEK 9) -179 -4,09 -2,83 -3,66 -2,61
------------------------------------------------------------------------------------------
Cash flow per share, SEK 10) -152 -3,50 -4,68 13,66 0,16
------------------------------------------------------------------------------------------
</TABLE>
1) Return on capital employed and return on equity have been calculated by
multiplying the six month operating loss and net loss by 2 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,
21,127. (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 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).
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: August 18, 2000 By: /s/ Anders Agering
--------------------------------
Anders Agering
Chief Financial Officer
