Biora AB -Report For the First Nine Months 2001.
Business Editors
MALMO, Sweden--(BUSINESS WIRE)--Nov. 7, 2001--
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3rd Qtr 3rd Qtr 9 Months 9 Months Full year
2001 2000 2001 2000 2000
Sales, SEK millions 22.0 22.8 77.8 66.4 89.2
Operating loss, SEK
millions - 11.5 -14.8 -26.7 -54.3 -78.7
Net loss, SEK millions- 11.0 -14.2 -25.7 -52.1 -76.1
-- Biora has strengthened its financial position through a private
placement of ordinary shares.
-- Sales during the first nine months of 2001 increased by 17% to SEK
77.8 million (compared to SEK 66.4 million during the same period
in 2000). The increase occurred primarily in the German (+43%) and
U.S. (+32%) markets.
-- Sales during the third quarter of 2001 decreased by 4% to SEK 22.0
million (compared to SEK 22.8 million during the same period in
2000). This was among other things negatively impacted by the
events during September in the U.S.
-- Sales have rebounded in October.
-- The net loss for the first nine months amounted to SEK 25.7
million, a 51% reduction in the amount of net losses compared to
the same period in 2000 (loss of SEK 52.1 million).
-- Biora has elected to voluntarily delist its American Depositary
Shares from the NASDAQ stock market.
-- Biora's CEO, Rickard Soderberg, has announced that he will resign
at the next annual general meeting.
Biora AB develops, manufactures and sells pharmaceutical products
to dentists. The principal product, Emdogain(R), which is approved for
sale in Europe, North America and Japan, naturally regenerates 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.
Report for the first nine months of 2001
Biora's sales during the first nine months of 2001 equaled SEK
77.8 million, compared to sales of SEK 66.4 million during the same
period in 2000. The rise in sales amounts to a 17% increase (5% at
fixed exchange rates) compared to the corresponding period in 2000.
The sales increase occurred primarily in the German and the U.S.
markets. No deliveries were made to Japan during the first nine months
in 2001 compared to deliveries to Japan of SEK 6.0 million during the
corresponding period in 2000. The increase in sales for the first nine
months in 2001 excluding the Japanese market was 29%.
Sales during the third quarter were SEK 22.0 million, compared to
SEK 22.8 million during the same period in 2000, a reduction of 4%
(-14% at fixed exchange-rates). Sales during the third quarter were
negatively impacted by the events of September 11th in the United
States. In addition, there were no deliveries to Japan during the
third quarter in 2001 compared to SEK 3.0 million during the same
period last year. Excluding the Japanese market, third quarter sales
in 2001 compared to the same period in 2000 increased by 11%.
MARKET
Sales in the German market increased by 43% during the first nine
months
Germany is Biora's largest European market. Sales for the first
nine months 2001 amounted to SEK 17.0 million compared to SEK 11.8
million during the same period in 2000, an increase of 43% (32% in
local currency). Sales during the third quarter 2001 equaled SEK 5.2
million, compared to SEK 3.5 million during the same period in 2000.
The continuing focus on key customers and an increased systematization
of the sales process are considered by Biora to be the most important
factors for the sales increase in Germany.
Sales in The United States were impacted by the events in September
United States is Biora's largest single market. Sales for the
first nine months 2001 amounted to SEK 42.3 million compared to SEK
32.1 million during the corresponding period in 2000, an increase of
32% (15 % in local currency). Sales during the third quarter of 2001
equaled SEK 12.6 million, compared to SEK 11.8 million during the
third quarter of 2000. Sales during the third quarter were negatively
impacted by the events in September. Biora reports that a rebound of
sales occurred in the U.S in October.
The registration process for EmdogainGel is in progress in Japan
During the first nine months of 2001 there were no deliveries to
Japan compared to deliveries of SEK 6.0 million during the same period
in 2000. The documentation for registration of EmdogainGel was
submitted to the Japanese registration authority in January 2001, and
the review process is on-going. The exact timing of registration of
the product in Japan is difficult to predict.
Introduction of EmdogainGel TS in Europe.
The introduction of EmdogainGel TS was initiated in the Nordic
countries and Germany during the month of October. EmdogainGel TS is a
product that gives periodontists an improved tool to treat patients
with wide periodontal defects. The agreement with USBiomaterials has
expanded Biora's sales territory, and gives Biora the opportunity to
introduce EmdogainGel TS in France and Spain.
RESEARCH AND DEVELOPMENT
The research projects focusing on dental indications are
continuing according to schedule. Consequently two new products have
recently been initiated.
-- New product for woundhealing in mechanical treatment of
periodontal pockets. A pilot study has begun.
-- New product got treatment of dental pulp. Early clinical tests
have begun.
Negotiations concerning divestiture of BioEx
Biora's Board of Directors has decided not to sell the entire
BioEx line, but there are currently negotiations to divest the wound
healing project.
OTHER INFORMATION
Biora has strengthened its financial position through a private
placement
On August 24, 2001, the Board of Directors approved a new share
issuance. The offering consisted of 2,550,000 ordinary shares at a
subscription price of SEK 10.40 per share. Upon the completion of the
offering, the company's cash balance was increased by SEK 26.5 million
and its share capital by SEK 102,000.The dilution following the new
issue was 10.7% in number of shares. The offering<180>s discounted
subscription price amounted to an effective dilution to existing
shareholders of SEK 0.24 per ordinary share. The right to subscribe
for new shares was directed to a number of European institutional
investors and major private investors, without giving existing
shareholders pre-emptive rights. The new shares were not registered in
the U.S. and the issue was not available to investors in the United
States. Biora currently has 23,753,800 ordinary shares outstanding.
The proceeds of the offering have strengthened the company's
financial position.
Biora AB has elected to voluntarily delist from the NASDAQ Stock
Market
Biora AB will voluntarily delist from the NASDAQ National Market
on which its American Depositary Shares are traded under the symbol
BIORY and move these shares to the OTC Bulletin Board. The principal
reason for the voluntary delisting is that the Company does not comply
today with the NASDAQ quantitative listing standards in regard to the
new minimum equity listing requirements that became effective June 29,
2001. Biora determines that it will not be in a position to qualify
for continued listing under the NASDAQ Marketplace Rules prior to the
end of the grace period at the end of November 2002.
There is currently only a small number of record holders of Biora
American Depositary Shares in the U.S. and the trading volume on
NASDAQ is limited. These factors combined with the high cost of
maintaining a separate listing in the U.S. caused the Company to
decide that it can no longer justify the continued maintenance of a
NASDAQ listing. Accordingly, Biora will be applying to voluntarily
delist its shares from the NASDAQ market and move to the OTC Bulletin
Board. The delisting is expected to occur during January 2002.
Biora's CEO announces that he will resign from the company
Rickard Soderberg, CEO, has announced that he will resign
effective at the next annual general meeting and the search for a new
CEO has begun.
Further, the company's Chief Financial Officer, Anders Agering,
has announced that he will leave his position March 1, 2002.
FINANCIAL INFORMATION
Net Sales
The Group's net sales during the first nine months increased to
SEK 77.8 million ( SEK 66.4 million in 2000) This corresponds to an
increase of 17% (5% at fixed exchange rates). For the third quarter,
net sales equaled SEK 22.0 million ( SEK 22.8 million in 2000).
Results
Gross profit during the first nine months 2001 amounted to SEK
60.6 million ( SEK 51.3 million in 2000). The improvement is due to
the increase in sales. Gross profit for the third quarter equaled SEK
17.5 million ( SEK 17.8 million in 2000).
The operating loss for the nine months 2001 amounted to SEK 26.7
(SEK 54.3 million loss in 2000). This is partly explained by the
increase in sales and partly by reduced operating costs. Selling
expenses were reduced by SEK 3.2 million and R&D costs were reduced by
SEK 11.5 million, of which SEK 7.9 million is because the Group's
capitalized R&D costs were completely amortized in the preceding year.
Other operating income consists principally of the installments for
the license agreement relating to a development project for xerostomia
(dry mouth).
For the third quarter the operating loss equaled SEK 11.5 million
(SEK 14.8 million loss in 2000)
Net financial items for the first nine months 2001 were SEK 1.0
million ( SEK 2.2 million in 2000). The reduction is mainly because
Biora had decreased interest bearing assets, and therefore lower
interest income during the first nine months compared to the
corresponding period in 2000.
Net loss after tax during the first nine months 2001 amounted to
SEK 25.7 million ( SEK 52.1 million loss in 2000) corresponding to a
loss per share of SEK 1,20 ( SEK 2.46 loss in 2000) based on the
average number of shares outstanding 21,427,976 ( 21,203,800 in 2000).
The loss for the third quarter was SEK 11.0 million ( SEK 14.2 million
loss in 2000), which corresponds to a loss per share of SEK 0,50 ( SEK
0.67 loss in 2000) based on the average number of shares outstanding
of 21,869,017 ( 21,203,800 in 2000).
Capital expenditures
Capital expenditures for tangible long-term assets and patents
during the first nine months were SEK 2.1 million (SEK 4.1 million in
2000).
Financial position
Net change in cash and cash equivalents during the first nine
months 2001 was negative, in an amount of SEK 0.3 million (SEK -46.5
million in 2000). During the third quarter 2001, the net increase in
cash and cash equivalents for the Group amounted to SEK 26.3 million
due to the new issuance of shares. The new issuance comprised
2,550,000 new shares at a subscription price of SEK 10.40 per share.
Biora's share capital increased by SEK 102,000.
At the end of the reporting period (figures for December 31, 2000,
for comparison, are given below in parentheses) the Group's liquid
funds amounted to SEK 53.4 million ( SEK 53.8 million), the
equity/assets ratio was 58.4 % (55.8 %) and the Group's equity
amounted to SEK 54.1 million (SEK 50.9 million).
The increase in current receivables is 50% caused by an increase
in accounts receivable due from customers , primarily as a result of
the increased sales.
Employees
As of September 30, 2001, the Group had 84 employees, compared to
75 at December 31, 2000.
Accounting principles
The accounting principles and calculation methods used in this
first nine months report are the same as those used in the annual
report 2000.
Coming financial information
Biora will publish financial information on the following dates:
Year end report for 2001 February 19, 2002
Distribution of Annual Report End of March, 2002
Interim Report for the first quarter 2002 April 29, 2002
Annual General Meeting April 29, 2002
-0-
Malmo, November 7, 2001
Rickard Soderberg
President and CEO
Biora's auditors have not audited this interim report.
Biora AB has registered the trademarks Emdogain(R) and
PrefGel(TM). In this report these registrations are only publicized in
this paragraph.
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
For further information, please contact:
- Tommie Johansson, Corporate Communications and Investor Relations,
Biora, tel: +46 40-32 13 65 or +46 70 32 21 365
- Anders Agering, Chief Financial Officer, Biora, tel: +46-40-32 12
17
- Rickard Soderberg, President and CEO of Biora, tel: +46 (0)40 32
13 59
- Elisabeth Lavers, Investor relations, Biora US tel: 203 977 7797
- http://www.biora.com
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CONSOLIDATED STATEMENTS OF OPERATIONS
(Swedish GAAP, unaudited)
2001 2001 2000 2001 2000 2000
Quarter 3rd Qtr 3rd Qtr Quarter Quarter Full
1-3 1-3 1-3 year
(TUSD) 1) (TSEK) (TSEK) (TSEK) (TSEK) (TSEK)
Net sales 7 578 21 958 22 789 77 805 66 433 89 160
Costs of goods
sold -1 678 -4 498 -5 002 -17 228 -15 139 -21 148
Gross profit 5 900 17 460 17 787 60 577 51 294 68 012
Selling expenses -5 231 -17 801 -17 791 -53 710 -56 907 -78 387
Administrative
expenses -1 661 -5 180 -4 857 -17 055 -17 685 -25 437
Research and development
costs -1 895 -5 622 -9 851 -19 456 -30 978 -42 789
Other operating income
and expenses 2) 288 -327 -122 2 962 4 -110
Loss from
operations -2 599 -11 470 -14 834 -26 682 -54 272 -78 711
Financial net 99 552 653 1 018 2 183 2 730
Loss after financial
items -2 500 -10 918 -14 181 -25 664 -52 089 -75 981
Income tax 3) -6 -39 - -61 - -168
Loss for the
period -2 506 -10 957 -14 181 -25 725 -52 089 -76 149
Loss per
share 4) -0,12 -0,50 -0,67 -1,20 -2,46 -3,59
Number of shares outstanding at
the end of the period
(000s) 23 754 23 754 21 204 23 754 21 204 21 204
Average number of shares
outstanding
(000s) 21 428 21 869 21 204 21 428 21 204 21 204
1) Average exchange rate Jan-Sep, 2001, USD 1 = 10,267
2) Instalments for license agreement regarding a development
project for xerostomia are included in other operating income by
3,002 TSEK in the first half year 2001.
3) The Company does not account for any tax income, neither regarding
the loss for the period nor regarding accumulated losses. Deferred
tax assets have been reduced by a valuation allowance to the
amount that is "more likely than not" to be realized. The net
deferred tax asset is zero.
4) Loss per share has been calculated by dividing the loss for the
period by the average number of shares.
Since the outstanding warrant programme does not result in any
dilution, the loss per share before and after dilution is the same.
CONSOLIDATED BALANCE SHEETS
Sep 30, Sep 30, Sep 30, Dec 31,
(Swedish GAAP, unaudited) 2001 2001 2000 2000
(TUSD) 1) (TSEK) (TSEK) (TSEK)
Intangible long term assets 725 7 441 10 510 7 112
Tangible long term assets 434 4 453 7 990 6 442
Financial long term assets 64 658 2 513 2 553
Total long term assets 1 223 12 552 21 013 16 107
Inventories 643 6 605 6 312 6 878
Current receivables 1 948 20 003 19 921 14 484
Bank deposits 2 525 25 920 50 000 40 000
Cash and bank 2 680 27 516 16 283 13 755
Total current assets 7 796 80 044 92 516 75 117
Total assets 9 019 92 596 113 529 91 224
Shareholders' equity 2) 5 270 54 111 75 276 50 915
Provisions 29 297 270 261
Long term liabilities 2), 3) 341 3 506 5 506 7 906
Current liabilities 3) 3 378 34 682 32 477 32 142
Total shareholders' equity
and liabilities 9 019 92 596 113 529 91 224
1) Average exchange rate Jan-Sep 2001, USD 1 = 10,267
2) Change in shareholders' equity
Share Other Accumu- Total
capital restricted lated
equity loss
Balance on January 1, 2001 848 144 862 -94 795 50 915
Disposition of loss in the Parent
Company -79 874 79 874 0
Earlier received option premiums matured 5 320 5 320
Issuance of new shares 102 23 741 23 843
Change in translation differences 326 -568 -242
Loss for the period -25 725 -25 725
Balance on September 30, 2001 950 89 055 -35 894 54 111
3) The interest bearing liabilities amounted to 2,400 on September
30, 2001, and on December 31, 2000 (September 30, 2000 0).
STATEMENTS OF CASH FLOWS
Consolidated (TSEK) 2001 2000 2001 2000 2000
(Swedish GAAP, unaudited) 3rd 3rd Quarter Quarter Full year
Qtr Qtr 1-3 1-3
Loss for the period -10 957 -14 181 -25 725 -52 089 -76 149
Depreciation and
amortization 1 398 1 430 4 006 5 207 8 852
Change in capitalized research
and development costs - 2 629 - 7 886 10 514
Other adjustments to reconcile
net loss to net cash flows
used in / from operating
activities -878 84 99 -71 220
Change in assets and
liabilities 2 546 -2 776 -6 475 -3 892 105
Net cash used in operating
activities -7 891 -12 814 -28 095 -42 959 -56 458
Capital expenditures
(tangible assets and patents)-933 -1 920 -2 119 -4 066 -5 498
Payments concerning other
long-term receivables - 6 1 920 6 6
Net cash used in investing
activities -933 -1 914 -199 -4 060 -5 492
Net cash from financing
activities 27 213 - 27 213 - 2 400
Effect of exchange rate changes
on cash and cash equivalents 207 481 762 498 501
Net change in cash and cash
equivalents 18 596 -14 247 -319 -46 521 -59 049
KEY RATIOS
Consolidated 2001 2000 2000 1999 1998
(Swedish GAAP, unaudited) Quarter Quarter Full Full Full
1-3 1-3 year year year 2)
Net sales (TSEK) 77 805 66 433 89 160 73 556 50 119
Gross margin, % 3) 77.9 77.2 76.3 79.0 78.3
R & D costs (TSEK) 4) 19 456 30 978 42 789 41 597 39 980
Return on capital
employed, % 1), 5) -61.8 -68.2 -83.7 -50.7 -40.0
Return on equity,% 1), 6) -65.3 -68.5 -85.4 -50.8 -40.0
Equity / assets ratio, % 7) 58.4 66.3 55.8 78.3 86.6
Net debt / equity
ratio, % 8) -94.3 -88.1 -100.9 -88.5 -87.4
Total equity (TSEK) 54 111 75 276 50 915 127 406 213 970
Average number of shares
outstanding, (000s) 9) 21 428 21 204 21 204 21 204 21 204
Equity per share, SEK 9) 2.53 3.55 2.40 6.01 10.09
Loss per share, SEK 9) -1.20 -2.46 -3.59 -4.09 -2.83
Cash flow per share,
SEK 10) -0.01 -2.19 -2.78 -3.50 -4.68
1) Return on capital employed and return on equity have been
calculated by multiplying the nine months 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
2001, as well as during 1998, 1999 and 2000, no costs have been
capitalized under the caption Capitalized R&D costs, which
explains why the net and gross costs were equal, 19,456. (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 dilution effects of outstanding options have not been
considered when calculating equity, loss and cash flow per share
for the years 1998-2001 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 note 9).
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--30--emb/ny*
CONTACT: President and CEO
Rickard Soderberg
+46 40 32 13 59
or
Investor Relations
Tommie Johansson
+ 46 70 32 21 365
or
Biora US Investor Relations
Elisabeth Lavers
+1 203 977 7797
KEYWORD: SWEDEN INTERNATIONAL EUROPE
INDUSTRY KEYWORD: BIOTECHNOLOGY MANUFACTURING MEDICAL
MEDICAL DEVICES PHARMACEUTICAL EARNINGS
SOURCE: Biora AB
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