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: May, 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 first quarter report for Biora AB.
REPORT FOR THE FIRST QUARTER 2000
BIORA AB (PUBL)
MAY 4, 2000
FULL YEAR 2000 1999 1999
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Sales, SEK millions 21.1 17.2 73.6
Operating loss, - - -
SEK millions 17.7 22.8 91.8
Net loss, SEK - - -
millions 16.9 20.9 86.7
O SALES DURING THE FIRST QUARTER 2000 INCREASED BY 23 PERCENT
TO SEK 21.1 MILLION (COMPARED TO SEK 17.2 MILLION DURING THE
SAME PERIOD IN 1999). THE INCREASE OCCURRED PRIMARILY IN THE
JAPANESE (+77% OVER FIRST QUARTER 99) AND THE U S (+71%)
MARKETS.
O SALES OF PREMIXED VERSION OF EMDOGAIN, EMDOGAIN(R)GEL, FOR
TREATMENT OF PERIODONTAL DISEASE, NOW STARTED IN EUROPE. IT
HAS ALSO BEEN APPROVED IN CANADA.
O NUMEROUS PRECLINICAL AND CLINICAL STUDIES SUPPORT EMDOGAIN'S
EFFECTS IN TREATMENT OF PERIODONTAL DISEASE.
O CELL STUDIES (CARCINOMA) SHOW THAT EMDOGAIN INHIBITS GROWTH
OF CERTAIN CANCER CELLS.
O THE RIGHTS ACQUIRED TO A PATENT- PROTECTED PHARMACEUTICAL
PROJECT AGAINST DRY MOUTH (XEROSTOMIA).
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
TOMAS HAMMARGREN MIKAEL SJOBLOM ELISABETH LAVERS
+46 40 32 13 36 + 46 40 32 13 65 +1 203 977 7797
REPORT FOR THE FIRST QUARTER OF 2000
Biora's sales during the first quarter of 2000, increased to SEK
21.1million, compared to SEK 17.2 million during the first quarter of 1999.
The increase occurred primarily in the American and Japanese markets.
SALES DURING 1999 AND 2000, BY QUARTER, MSEK
[GRAPHIC?OMITTED]
DEVELOPMENT OF SALES BASED ON ROLLING TWELVE MONTHS FIGURES,
APRIL 1999 - MARCH 2000, SEK MILLIONS
[GRAPHIC?OMITTED]
CONTINUED SALES INCREASE IN THE AMERICAN AND JAPANESE MARKETS
The total increase in sales during the period was 23 percent compared to
first quarter 99. The US is Biora's largest single market and sales there
increased by 711) percent during the report period. The total number of
customers in the US was 2650 at the end of the reporting period and almost
1400 of them had purchased more than once.
In Japan Biora's products are marketed by the Japanese biotechnology
company Seikagaku Corporation. Sales by Biora to Seikagaku increased by
771) percent compared with the first quarter of 1999. According to
Seikagaku, the number of customers at the end of the reporting period was
about 1,100, of which 510 had purchased Emdogain more than once.
DECREASED SALES IN GERMANY
Sales in Germany decreased during the period by 241 percent compared to
1999. Measures have been taken to improve the situation. In Germany about
7000 customers had purchased Emdogain at the end of the reporting period,
and 4000 of them had purchased more than once.
Sales in the Nordic countries decreased by 161 percent. In Sweden sales
increased by nine percent and the number of customers were 660, of which
490 had purchased more than once. In Italy sales increased by two(1) percent.
-----------
(1) The reported changes are in Swedish crowns. In local currencies the
changes were: U.S. +60%, Japan +45%, Germany -19%, the Nordic
countries -16% and Italy +9%.
SALES OF EMDOGAIN(R)GEL HAS NOW STARTED 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. At the end of March Emdogain(R)Gel was approved in Europe
and Canada and has just been introduced in Europe. The application for
approval in the U.S. has been submitted to the Food and Drug Administration.
BIORA.COM
Our home page "biora.com" will play a significant role in our future sales
and marketing activities. The upgrading that will be launched during second
quarter will enable us to cultivate new, larger customer groups as well as
patients in a cost efficient manner.
NUMEROUS STUDIES SUPPORT EMDOGAIN'S EFFECTS IN THE TREATMENT OF PERIODONTITIS
Biora's emphasis on research and development as well as increasing clinical
use of Emdogain is producing numerous published studies. The total number
of published studies now amounts to approximately 60, published in (Europe,
North America, Japan and Australia. The third book about treatment with
Emdogain, written by Dr. Hideaki Hirooka and Dr. Shin-ichi Tomura, was
published in Japan during March.
IMPORTANT PROGRESS IN RESEARCH AND DEVELOPMENT
Since its public offering in 1997 Biora has invested substantial resources
in research concerning matrix proteins. This investment has produced
results during 1999/2000that indicate some new areas as described below of
use for Emdogain and other enamel matrix proteins.
DEVELOPMENT OF NEW DENTAL INDICATIONS
For new dental indications of Emdogain, clinical studies are continuing for
expanded treatment of periodontitis, treatment of recession type defects,
knocked-out teeth, periodontitis in connection with impacted wisdom teeth
as well as wound healing. The indication tooth trauma (knocked-out teeth)
has been approved in Europe and will be introduced at an international
conference in Oslo in June.
WOUND HEALING
The use of Emdogain has been shown to be accompanied by good healing
following surgery in the treatment of periodontitis. This effect is
believed to occur because 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.
Clinical pilot studies will begin during 2000. This group of advanced wound
healing products is expected to belong to the fastest growing part of the
wound healing market (source: Bridgehead report Nov. 1999).
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.
The first clinical studies will test Emdogain as an adjunct to traditional
cancer treatment and will begin during the year.
LOCAL BONE FORMATION
Biora has found in new pilot studies that certain enamel matrix proteins
stimulate local formation of new bone. The continuing work is intended to
document the effect and to determine future areas for indications. Biora is
heading a collaboration project with four European universities, which
among other things is applying for funding within the fifth frame program
of the European commission. The goal is to prove that enamel matrix
proteins can be as or even more effective than the growth factors being
developed today.
DRY MOUTH (XEROSTOMIA)
During the reporting period Biora has acquired the rights to a new
patent-protected pharmaceutical project for treating dry mouth
(xerostomia). Dry mouth affects a large percentage of the older population.
Approximately 15% of all 50 year olds and 40% of those over 80 suffer from
dry mouth. Dry mouth is also a common side effect of many types of
medication and radiation treatment.
The substance has been preliminary tested on healthy volunteers as well as
patients with dry mouth. The remaining development work is to produce a
final formulation and carry out clinical studies. Clinical studies are
planned to begin during year 2000.
NET SALES
The Group's net sales during the period increased to SEK 21.1million (1999:
SEK 17.2 million).
PROFIT/LOSS
Gross profit amounted to SEK 16.2 million (1999: SEK 13.2 million). The
improvement can be explained by the increase in sales. The operating loss
amounted to SEK 17.7million (1999: SEK-22.8 million loss).
During the period the operating expenses have decreased by approximately
six percent, SEK 2.1 million. Restructuring of the European marketing
organization has contributed to lower selling expenses while sales
increased by 23 percent. Net financial items were SEK 0.8million (1999: SEK
1.9 million). The decrease is explained by decreased interest bearing
assets.
Net loss after tax during the period amounted to SEK 16.9 million (1999:
SEK 20.9 million loss), corresponding to a loss per share of SEK 080 (1999:
SEK 0.98 loss) based on the average of number of shares outstanding.
INVESTMENTS
Capital expenditures during the period totaled SEK 0.7 million (1999: SEK
1.1 million).
FINANCIAL POSITION
Net change in cash and cash equivalents during the period was negative, in
an amount of SEK 17.2 million (1999: neg. SEK 24.7 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 95.6
million (112.8.million), the equity/assets ratio was 76.7 %(78.3 %) and the
Group equity amounted to SEK 110.5 million (127.4 million).
EMPLOYEES
As of March 31, 2000, Biora had 84 employees, compared to 92 at year-end
1999.
COMING FINANCIAL INFORMATION Biora will publish financial information for
2000 on the following dates:
Half year report August 18
Interim report for the third quarter - November 2
Malmo, May 4,2000
Tomas Hammargren, 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 1999
(Swedish GAAP, unaudited) Jan - Mar JAN - MAR Jan - Mar Jan - Dec
(TUSD) 1) (TSEK) (TSEK) (TSEK)
<S> <C> <C> <C> <C>
Net sales 2 438 21 144 17 234 73 556
Costs of goods sold -575 -4 985 -4 074 -15 470
Gross profit 1 863 16 159 13 160 58 086
Selling expenses -2 184 -18 938 -20 710 -90 783
Administrative expenses -542 -4 700 -4 138 -18 505
Research and development costs -1 189 -10 312 -10 280 -41 597
Other operating income and expenses 12 104 -790 994
Loss from operations -2 039 -17 687 -22 758 -91 805
Financial net 91 792 1 935 5 220
Loss after financial items -1 948 -16 895 -20 823 -86 585
Income tax - - -32 -154
Loss for the period -1 948 -16 895 -20 855 -86 739
CONSOLIDATED BALANCE SHEETS
Mar 31, MAR 31, Mar 31, Dec 31,
(Swedish GAAP, unaudited) 2000 2000 1999 1999
(TUSD) 1) (TSEK) (TSEK) (TSEK)
Intangible long term assets 1 720 14 921 23 656 16 573
Tangible long term assets 1 158 10 041 11 912 10 843
Financial long term assets 292 2 528 2 531 2 534
Total long term assets 3 170 27 490 38 099 29 950
Inventories 535 4 642 4 585 5 175
Current receivables 1 878 16 288 20 704 14 807
Bank deposits 9 225 80 000 104 145 90 000
Cash and bank 1 800 15 612 58 173 22 804
Total current assets 13 438 116 542 187 607 132 786
Total assets 16 608 144 032 225 706 162 736
Shareholders' equity 12 737 110 465 194 190 127 406
Provisions 30 257 411 444
Long term liabilities 2), 3) 635 5 506 5 475 5 505
Current liabilities 2), 3) 3 206 27 804 25 630 29 381
Total shareholders' equity and liabilities 16 608 144 032 225 706 162 736
1) Average exchange rate Jan-Mar , 2000, USD 1 = 8,6725
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 March
31, 2000, March 31, 1999 nor December 31, 1999.
</TABLE>
<TABLE>
<CAPTION>
STATEMENTS OF CASH FLOWS
CONSOLIDATED (TSEK) 2000 1999 1999
(Swedish GAAP, unaudited) JAN - MAR Jan - Mar Jan - Dec
<S> <C> <C> <C>
Loss for the period -16 895 -20 855 -86 739
Depreciation and amortization 1 365 1 286 5 552
Change in capitalized research and
development costs 2 628 1 776 8 595
Other adjustments to reconcile net
loss to net used in operating activities -170 38 541
Change in assets and liabilities -2 459 -5 635 2 447
Net cash used in operating activities -15 531 -23 390 -69 604
Capital expenditures (tangible assets
and patents) -1 587 -1 133 -4 334
Other investing activities - 31 -29
Net cash used in investing activities -1 587 -1 102 -4 363
Net cash used in financing activities - - -
Effect of exchange rate changes on
cash and cash equivalents -74 -238 -277
Net change in cash and cash equivalents -17 192 -24 730 -74 244
KEY RATIOS
CONSOLIDATED 2000 1999 1998(2) 1997 1996
(Swedish GAAP, unaudited) JAN - MAR(1)
Net sales (TSEK) 21 144 73 556 50 119 16 499 4 561
Gross margin, % (3) 76,4 79,0 78,3 66,5 1,1
R & D costs (TSEK) (4) 10 312 41 597 39 980 21 207 10 884
Return on capital employed, % (5) -56,5 -50,7 -40,0 -53,2 -266,2
Return on equity,% (6) -56,8 -50,8 -40,0 -58,1 neg
Equity / assets ratio, % (7) 76,7 78,3 86,6 81,9 -34,2
Net debt / equity ratio, % (8) -86,6 -88,5 -87,4 -103,0 -84,3
Total equity (TSEK) 110 465 127 406 213 970 277 935 -18 437
Average number of shares
outstanding, (000s) (9) 21 204 21 204 21 204 20 571 14 207
Equity per share, SEK (9) 5,21 6,01 10,09 13,51 -1,30
Loss per share, SEK (9) -3,19 -4,09 -2,83 -3,66 -2,61
Cash flow per share, SEK (10) -3,24 -3,50 -4,68 13,66 0,16
(1) Return on capital employed, return on equity, loss per share and
cash flow per share have been calculated by multiplying the three
month operating loss, net loss and cash flow by 4 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, 10,312. (2.5% royalty to Astra on sales
of Emdogain
(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 pro forma
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).
</TABLE>
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: June 6, 2000 By: /s/ Anders Agering
--------------------
Anders Agering
Chief Financial Officer
