2007-10-26 09:40:27 CEST
2007-10-26 09:40:27 CEST
REGULATED INFORMATION
Biotie Therapies - Quarterly report
INTERIM REPORT ON BIOTIE THERAPIES CORP. JANUARY 1 - SEPTEMBER 30, 2007
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE
October 26, 2007
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE
October 26, 2007
INTERIM REPORT ON BIOTIE THERAPIES CORP. JANUARY 1 - SEPTEMBER 30,
2007
January - September 2007 in brief
In September 2007 Biotie started the first phase I clinical trial
with its fully human VAP-1 monoclonal antibody.
The net income in January - September, 2007 was EUR 0.6 million
positive (in 2006 EUR -5.5 million). Cash flow from operating
activities was EUR -4.1 million (EUR -4.9 million in 2006).
The company's liquid assets amounted to EUR 29.3 million as at
September 30, 2007 (at September 30, 2006, EUR 3.8 million).
Drug development programs
Nalmefene program
Biotie announced on May 23, 2007 that the licensing agreement entered
into force on H. Lundbeck A/S worldwide rights for nalmefene,
excluding North America, Mexico, UK, Ireland, Turkey, and
South-Korea.
In June 2007 Biotie withdrew the UK national marketing authorisation
application on nalmefene in its alcoholism indication to enable a
centralised EU-wide registration procedure in due course.
To maximise nalmefene's potential in the treatment of alcoholism
Biotie and Lundbeck have jointly decided to seek marketing
authorisation simultaneously in all 27 EU member states via the
centralized procedure. To this end, Lundbeck plans to further
strengthen the existing nalmefene registration dossier in its
alcoholism indication with additional phase III clinical studies
before submitting the marketing authorisation application. The
studies are expected to start in 2008.
As previously announced, subsequent to the Biotie clinical program
for nalmefene in alcoholism being completed, there is currently a
regulatory requirement for an electrocardiogram (ECG) study in
healthy volunteers. After the reporting period in October 2007 Biotie
has started such a clinical trial with nalmefene evaluating the
cardiac effects on healthy volunteers measured using an
electrocardiogram. The study is expected to enrol 240 healthy
volunteers and to be completed in 2008 and included in the eventual
registration dossier.
Biotie has received from Lundbeck an execution fee of EUR 12 million,
of which EUR 10 million was paid on signing in November 2006 and EUR
2 million was paid on the license entering into force in May 2007. In
total, Biotie is eligible for up to EUR 80 million in upfront and
milestone payments plus royalty on sales. Biotie will participate in
financing some of the clinical development costs.
VAP-1 antibody program
In September 2007 Biotie started the first phase I clinical trial
with its fully human VAP-1 monoclonal antibody. The study start
triggers a EUR 2 million payment from Roche.
This first-in-man study evaluates the safety, tolerability, and
pharmacokinetics of intravenously administered antibody in healthy
volunteers. Results are expected during the second quarter of 2008.
In November 2006, Biotie and Roche signed an option agreement for
Biotie's fully human antibody program targeting Vascular Adhesion
Protein-1 (VAP-1) in inflammatory diseases.
Under the terms of the agreement, Roche will pay an option initiation
fee of EUR 5 million, which grants Roche an exclusive option right to
an exclusive, worldwide license agreement for Biotie's fully human
antibody targeting VAP-1, excluding Japan, Taiwan, Singapore, New
Zealand, and Australia. The option initiation fee will be paid in two
instalments. Biotie received the first instalment of EUR 3 million in
2006 and Roche will pay the second instalment of EUR 2 million in
2007 triggered by the study start. The initial option right will end
upon completion of Phase I. Roche may extend the option right to
later development points by paying additional fees. Biotie will
retain all rights to the program until a license is granted to Roche.
Inhibiting VAP-1 reduces inflammation by regulating the migration of
leukocytes, or white blood cells, to inflamed tissues. Pathological
accumulation of white blood cells in tissue is a common feature in
many autoimmune diseases, such as rheumatoid arthritis, ulcerative
colitis, and psoriasis.
Pre-clinical programs
Pre-clinical programs (VAP-1 SSAO small molecule inhibitor program
and alfa2beta1 integrin inhibitor program) progressed as planned. In
the recombinant heparin program the company continued to look for a
partner to finance the future development of the program.
Revenue
Revenue for the reporting period January - September 2007 consists of
periodization of the signing fee of the licensing agreement signed
with Seikagaku Corporation in 2003, periodization of the signing fee
of the licensing agreement signed with Somaxon Pharmaceuticals in
2004, periodization of the option fee of the option agreement signed
with Roche in 2006 as well as periodization of the execution fee of
the licensing agreement signed with Lundbeck that entered into force
in May 2007. EUR 4 million was booked as revenue in the second
quarter of 2007 of the execution fee of EUR 12 million paid by
Lundbeck to Biotie. The rest of the EUR 12 million is expected to be
recognized as revenue against clinical development costs in
2007-2009. Of the EUR 12 million, EUR 10 million was paid on signing
in November 2006 and EUR 2 million was paid on the license entering
into force in May 2007. The revenue for the reporting period January
- September, 2007 was in total EUR 6.7 million.
Revenue for the period January - September, 2006 consisted of
periodization of the signing fee of the licensing agreement signed
with Seikagaku Corporation in 2003 and periodization of the signing
fee of the lisensing agreement signed with Somaxon Pharmaceuticals in
2004. The revenue was in total EUR 0.7 million. No new milestone or
signing fees were received during the period.
Financial results
The net profit for the reporting period January - September 2007 was
EUR 0.6 million. The comparable loss for the previous year was EUR
5.5 million. Research and development costs for the period amounted
to EUR 5.8 million (in 2006 EUR 4.1 million). Patent costs have been
booked as expenses.
Financing
Biotie's equity ratio was -29.5 % on September 30, 2007 (-474.0 % in
2006). Cash and cash equivalents totaled EUR 29.3 million on
September 30, 2007 (EUR 3.8 million in 2006).
Equity
A total of 231,200 new shares in Biotie Therapies Corp. have been
subscribed for by exercising the series A option rights of the
company's option scheme issued on March 30, 2006. The subscription
price of the shares was EUR 0.60 per share. The new shares have been
entered in the Finnish Trade Register on April 30, 2007. Following
the increase, the total number of shares in Biotie Therapies Corp.
was 90,031,860, and the subscription price has been recorded in the
reserve for invested unrestricted equity.
So far, a total of 231,200 new shares have been subscribed for
pursuant to the series A option rights of the company's option scheme
issued by the company on March 30, 2006.
Pursuant to the convertible capital loan issued on March 25, 2004, a
total of 450,000 new shares has been subscribed for. The new shares
have been entered in the Finnish Trade Register on April 2, 2007 and
May 11, 2007. Following the increase, the total number of shares in
Biotie Therapies Corp. is 90.211.860. The loan capital converted in
connection with the subscription amounts to EUR 840,939.62. The
conversion price paid has been recorded in the reserve for invested
unrestricted equity.
Relating to the company's option programs, the company has signed a
stock lending agreement with EVLI Bank in January, 2007.
Investments and cash flow
The company's investments during the reporting period amounted to EUR
15 thousand (EUR 57 thousand in 2006). The investments mainly
comprised of equipment purchased for research and development
operations. Cash flow from operating activities was EUR -4.1 million
(EUR -4.9 million in 2006). Research and development expenses are
booked as costs.
Personnel
During the reporting period, the company's personnel was on average
35 (38 in 2006) and at the end of the period 36 (36 on September 30,
2006).
The ten biggest shareholders of Biotie on September 30, 2007
Number of
shares %
Pequot group: 21 925 024 24.51
- Pequot Healthcare Fund, L.P. (7 765 345)
- Pequot Healthcare Offshore Fund, Inc.
(5 937 983)
- Premium Series PCC Limited (998 490)
- Pequot Diversified Master Fund Ltd.
(1 201 800)
- Pequot Healthcare Institutional Fund, L.P
(1 521 406)
- Pequot Healthcare Emerging Markets Fund,
Ltd. (4 500 000)
Finnish Innovation Fund (Sitra) 14 585 350 16.30
Finnish Industry Investment Ltd 6 778 592 7.58
Juha Jouhki and his controlled companies 6 537 672 7.31
- Dreadnought Finance Oy (2 098 416)
- Jouhki Juha (1 501 356)
- Thominvest Oy (2 937 900)
Funds administered by BioFund Management Oy: 2 549 775 2.85
- BioFund Ventures III Ky (2 485 715)
- BioFund Ventures I Ky (64 060)
Harri Markkula and his controlled company: 1 298 813 1.45
- Tilator Oy (676 264)
- Markkula Harri (622 549)
Oy H. Kuningas & Co AB 1 058 371 1.18
Oksanen Markku 550 000 0.61
Siven Pertti 355 000 0.40
Funds administered by Aboa Venture Management
Oy: 344 618 0.39
- Aboa Venture Ky II (336 747)
- Karhu Pääomarahasto Ky (7 871)
55 983 215 62.58
Nominee registered shares total 6 986 337 7.81
Other shareholders 26 493 308 29.61
Outstanding shares 89 462 860 100.00
The number of the company's own shares held by
Biotie Therapies 749 000
Total 90 211 860
IFRS and Accounting principles
The interim report does not comply with all requirements of IAS 34,
Interim Financial Reporting. Biotie has applied the same accounting
principles as in the closing of year 2006.
This interim report is unaudited.
Risks and Risk Management
Biotie's strategic risks are related to the technical success of the
drug development programs, regulatory issues, the strategic decisions
of its commercial partners, ability to obtain and maintain
intellectual property rights for its products, validity of its
patents, launch of competitive products and the development of the
sales of its products. For example, even though the commercialisation
and collaboration agreements on the company's product development
projects have been concluded, there can be no assurance that the
contracting partner will act in accordance with the agreement, the
authorities will approve the product under development or the
approved product will be commercialised. The development and success
of the company's products depends on third parties.
The operational risks include dependency of key personnel, assets and
dependency on partners' decisions.
Future outlook
The EUR 2 million option fee payment from Roche is expected during
the fourth quarter of 2007. The company is not expecting additional
new milestone payments based on other agreements in 2007.
Biotie's total revenue in IFRS reporting for 2007 is expected to be
approximately EUR 8-9 million, and the operating costs will increase
to a somewhat higher level for 2007 than in 2006.
Biotie 2007 financial result is expected to improve compared to year
2006, but the company expects to report a loss for the full year
2007.
The operating costs are expected increase to a somewhat higher level
for 2008 than in 2007. The company is not expecting new milestone
payments based on existing agreements in 2008.
In Turku, October 26, 2007
Biotie Therapies Corp.
Board of Directors
For further information, please contact:
Timo Veromaa, President and CEO, Biotie Therapies Corp.
tel. +358 2 274 8901, e-mail: timo.veromaa@biotie.com
www.biotie.com
Distribution:
OMX Nordic Exchange Helsinki Oy
Main Media
APPENDICES TO THE INTERIM REPORT
Income statement
Balance sheet
Statement of changes in shareholders' equity
Cash flow statement
Key figures
Formulas for the calculation of the financial ratios
FINANCIAL
STATEMENT
1.7.- 1.7.- 1.1.- 1.1.- 1.1.-
EUR 1,000 30.09.2007 30.09.2006 30.09.2007 30.09.2006 30.12.2006
3 months 3 months 9 months 9 months 12 months
Revenue 1,520 250 6,730 748 1,118
Research and -2,263 -799 -5,812 -4,139 -7,970
Development
expenses
General and -313 -407 -1,276 -2,100 -2,207
administrative
expenses
Other 186 121 870 540 698
operating
income
Operating -871 -836 512 -4,952 -8,361
profit/loss
Financial 127 30 728 100 215
income
Financial -196 -208 -597 -602 -812
expenses
Profit/loss -940 -1,013 643 -5,453 -8,958
before taxes
Taxes 0 0 0 0 -7
Net -940 -1,013 643 -5,453 -8,964
income/loss
Distribution
To parent -940 -1,013 643 -5,453 -8,964
company
Shareholders
Earnings per -0.01 -0.02 0.01 -0.10 -0.16
share (EPS)
basic and
diluted, EUR
BALANCE SHEET
EUR 1,000 30.09.2007 30.09.2006 30.12.2006
Assets
Non-current assets
Intangible assets 760 819 801
Property, plant and equipment 78 131 109
Financial assets at fair value 16,621 20,000
through profit or loss
17,459 950 20,910
Current assets
Current receivables 840 492 560
Financial assets at fair value 12,000 3,332 7,878
through profit or loss
Cash and cash equivalents 642 491 3,886
13,482 4,316 12,323
Total 30,941 5,266 33,233
Equity and liabilities
Shareholders' equity
Share capital 19,850 1,054 19,850
Reserve for invested unrestricted 980
equity
Retained earnigs -30,589 -20,559 -21,692
Net income/loss 643 -5,453 -8,964
Shareholders' equity total -9,117 -24,959 -10,807
Long-term liabilities
Provisions 15 24 27
Interest-bearing liabilities 23,493 22,918 23,508
Non-interest-bearing liabilities 9,836 4,772 6,528
33,344 27,715 30,063
Current liabilities
Provisions 16 16 16
Interest-bearing liabilities 11 33 27
Accounts payable and other debts 6,687 2,460 13,934
6,714 2,510 13,977
Liabilities total 40,058 30,224 44,040
Total 30,941 5,266 33,233
STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY
Parent company shareholders' equity
EUR 1,000 Shares Share Reserve for Share Own Retained Share-
(1000 Capital invested Premium Shares Earnings holders'
pcs) unrestricted fund equity
equity total
Balance at 52,675 1,054 0 5,881 -15 -26,502 -19,583
1.1.2006
Net -5,453 -5,453
income/loss
for the
period
Options 78 78
granted
Transfer -5,881 5,881 0
from share
premium fund
0 0 0 -5,881 0 505 -5,376
BALANCE AT 52,675 1,054 0 0 -15 -25,997 -24,959
30.09.2006
Net -3,511 -3,511
income/loss
for the
period
Options 24 24
granted
Share issue 36,855 18,796 -1,157 17,639
36,855 18,796 0 0 0 -4,645 14,151
BALANCE AT 89,531 19,850 0 0 -15 -30,641 -10,807
30.12.2006
Net 643 643
income/loss
for the
period
Options 68 68
granted
Share 450 139 139
subscription
with
convertible
capital
loans
Share 231 841 841
subscription
with option
rights
681 0 980 0 0 711 1,690
BALANCE AT 90,212 19,850 980 0 -15 -29,930 -9,117
30.9.2007
CASH FLOW STATEMENT
1.1.- 1.1.- 1.1.-
30.09.2007 30.09.2006 30.12.2006
EUR 1,000 9 months 9 months 12 months
Cash flow from operating
Activities
Net income/loss 643 -5,453 -8,964
Adjustments:
Non-cash transactions 140 374 1,249
Addition/disposal due to -606 -19 -84
revaluation
of financial assets at fair
value through profit or loss
Interest expenses and other 598 602 812
financial expenses
Interest income -728 -100 -215
Taxes 7
Change in working capital:
Change in trade and other -254 81 -19
receivables
Change in trade creditors and -3,951 -489 12,535
other liabilities
Change in mandatory provisions 12 -15 -12
Interests paid -15 -20 -25
Interests received 108 100 131
Taxes paid -7
Net cash from operating activities -4,053 -4,938 5,408
Cash flow from investing
activities
Change in financial assets at
fair value through profit or loss
Additions -3,000 -25,000
Disposals 2,952 3,450 4,000
Investments to tangible assets -15 -57 -819
Sale of associated companies 45 45
Net cash used in investing -63 3,438 -21,773
activities
Cash flow from financing
activities
Payments from share issue 139 17,639
Proceeds from borrowings 786 1,642 2,232
Repayment of loans -40
Repayment of lease commitments -14 -47 -15
Net cash from financing 872 1,595 19,856
activities
Net increase (+) or decrease (-) -3,244 96 3,490
in cash and cash equivalents
Cash and cash equivalents in the 3,886 395 395
beginning of the period
Cash and cash equivalents in the 642 491 3,886
end of the period
KEY FIGURES
1.1.- 1.1.- 1.1.-
30.09.2007 30.09.2006 30.12.2006
EUR 1,000 9 months 9 months 12 months
Business development
Revenues 6,730 748 1,118
Personnel on average 35 38 37
Personnel at the end of period 36 36 35
Research and development costs 5,812 4,139 7,970
Capital expenditure 15 57 819
Profitability
Operating profit/loss 512 -4,952 -8,361
as percentage of revenues, % 7.6 -662.4 -747.6
Profit/loss before taxes 643 -5,453 -8,958
as percentage of revenues, % 9.5 -729.5 -800.9
Balance sheet
Cash and cash equivalents 29,263 3,824 31,763
Shareholders equity -9,117 -24,959 -10,807
Balance sheet total 30,941 5,266 33,233
Financial ratios
Return on equity, % - -
Return on capital employed, % 12.2 - -113.5
Equity ratio, % -29.5 -474.0 -46.5
Gearing, % 63.2 -76.6 76.1
Per share data
Earnings per share (EPS), EUR 0.01 -0.10 -0.16
Shareholders'equity per share, EUR -0.10 -0.47 -0.12
Divided per share, EUR
Pay-out ratio, %
Effective dividend yield, %
P/E-ratio
Share price
Lowest share price, EUR 0.83 0.49 0.49
Highest share price, EUR 1.22 0.91 2.39
Average share price, EUR 0.99 0.64 1.10
Share price at the end of period, 1.04 0.64 1.18
EUR
Market capitalization at the end of 93.8 33.7 105.6
period MEUR
Trading of shares
Number of shares traded 31,727,304 9,659,876 32,470,230
As percentage of all 35.2 18.3 36.3
Adjusted weighted average 89,831,492 52,675,221 54,995,830
number of shares during the period
Adjusted number of shares at the end 90,211,860 52,675,221 89,530,660
of the period
Contingent liabilities
EUR 1,000 30.09.2007 30.09.2006 30.12.2006
Lease commitments 120 70 73
Formulas for the Calculation of the Financial Ratios
In the following formulas capital loans are included in interest
bearing liabilities and not in shareholders' equity.
Return on equity, %
Profit (loss) before extraordinary items - taxes
--------------------------------------------------------------- x 100
Shareholders' equity
Return on capital employed, %
Profit (loss) before taxes + interest expenses and other financial
expenses
--------------------------------------------------------------- x 100
Balance sheet total - non-interest bearing liabilities
Equity ratio, %
Shareholders' equity
--------------------------------------------------------------- x 100
Balance sheet total - advanced received
Gearing, %
Interest bearing liabilities - cash and cash equivalents
-------------------------------------------------------------- x 100
Shareholders' equity
Earnings per share (EPS)
Profit before extraordinary items, appropriations and taxes -
minority interest - taxes
------------------------------------------------------------------
Adjusted average number of outstanding shares during the period
Shareholders' equity per share
Shareholders' equity
------------------------------------------------------------------
Adjusted average number of shares at the end of the period
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