2007-04-27 09:01:10 CEST
2007-04-27 09:01:10 CEST
REGULATED INFORMATION
Biotie Therapies - Quarterly report
INTERIM REPORT ON BIOTIE THERAPIES CORP. JANUARY 1 - MARCH 31, 2007
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE April 27, 2007
http://hugin.info/132030/R/1122627/207170.pdf
January - March 2007 in brief
The net loss in January - March stood at EUR 1.1 million (in 2006 EUR
-2.3 million). Cash flow from operating activities was EUR -2.6
million (EUR -2.2 million in 2006).
The company's liquid assets amounted to EUR 29.4 million as at March
31, 2006 (at March 2006, EUR 6.2 million).
Drug development projects
Nalmefene program
In November, BioTie and H. Lundbeck A/S signed an agreement on
worldwide rights for nalmefene, excluding North America, Mexico, UK,
Ireland, Turkey, and South-Korea. Under the terms of the agreement,
BioTie has granted Lundbeck an exclusive license to market and
distribute nalmefene as a prescription medicine for the treatment of
substance abuse disorders and impulse control disorders.
Under the terms of the agreement, BioTie will receive an execution
fee of EUR 15 million, of which EUR 10 million was paid on signing.
Once the license enters into force, 15 million euros is expected to
be booked as revenue during 2007. In total, BioTie is eligible for up
to EUR 88 million in upfront and milestone payments plus royalty on
sales. Lundbeck will be responsible for manufacturing and
registration of the product in its territory.
BioTie submitted a marketing authorisation application regarding
nalmefene in the treatment of alcoholism to the UK Medicines and
Healthcare Regulatory Authority (the "MHRA") in November 2006.
Decision from the MHRA on the marketing authorisation for nalmefene
in the UK is expected in the second half of 2007.
VAP-1 antibody program
In November 2006, BioTie and F. Hoffmann La Roche (Roche) signed an
option agreement for BioTie's fully human antibody program targeting
Vascular Adhesion Protein-1 (VAP-1) in inflammatory diseases.
Inhibiting VAP-1 reduces inflammation by regulating the migration of
leukocytes, or white blood cells, to inflamed tissues.
The immaterial rights of the antibody program were further
strengthened by filing a new patent application in the EU and US
after the reporting period in April. Fully human VAP-1 monoclonal
antibody program is expected to enter into clinical development phase
during the first half of 2007.
Other pre-clinical programs
Other pre-clinical programs (VAP-1 SSAO small molecule inhibitor
program and alfa2beta1 integrin inhibitor program) progressed as
planned. The immaterial rights of the alfa2beta1 integrin program
were further strengthened by filing a new patent application in the
EU and US after the reporting period in April. In the recombinant
heparin program the company continued to look for a partner to
finance the future development of the program.
Revenues
Revenue for the reporting period 1.1-31.3.2007 consisted of
periodization of the signing of the licensing agreement signed with
Seikagaku Corporation in 2003 and periodization of the signing fee of
the licensing agreement in nalmefene project signed with Somaxon
Pharmaceuticals in 2004 and periodization of the option fee of the
option agreement signed with Roche in 2006. The revenue was in total
EUR 0.6 million. No new milestone or signing fees were received
during the period.
Revenue for the period 1.1.-31.3.2006 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
Nalmefene lisensing agreement signed with Somaxon Pharmaceuticals in
2004. The revenue was in total 0.2 million euros and consisted of
periodization of existing agreements. No new milestone or signing
fees were received during period 1.1.-31.3.2006.
Financial results
The net loss for the reporting period was EUR 1.1 million. The
comparable loss for the previous year was EUR 2.3 million. Research
and development costs for the period amounted to EUR 1.5 million (in
2006 EUR 1.8 million). Patent costs have been booked as expenses.
Financing
BioTie's equity ratio was -56.6 % on March 31, 2007 (-269.4 % in
2006). Cash and cash equivalents totalled EUR 29.4 million on March
31, 2007 (EUR 6.2 million in 2006).
Equity
After the reporting period the company announced that pursuant to the
convertible capital loan been determined by Biotie Therapies Corp. on
March 25, 2004, the total of 270,000 new shares has been subscribed
for. The new shares have been entered in the Finnish Trade Register
on April 2, 2007. Following the increase, the total number of shares
in Biotie Therapies Corp. is 89,800,660. The loan capital converted
in connection with the subscription amounts to EUR 504,563.77. The
exercise price paid will be recorded in the fund for invested
non-restricted 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
7 thousand (EUR 3 thousand in 2006). The investments mainly comprised
of equipment purchased for research and development operations. Cash
flow from operating activities was EUR -2.6 million (EUR -2.2 million
in 2006).
Management and personnel
Ulla Sjöblom, M.Sc. (econ), has been nominated Corporate Controller
and member of the management team to replace controller Leena Hyytiä.
Ms Sjöblom will start in July. Kai Lähdesmäki, VP Business
Development, will turn 62 in 2007. On Lähdesmäki's initiative a
gradual decrease in workload during 2007 is planned. Lähdesmäki will
carry out his duties in a consulting arrangement from April onwards.
During the reporting period, the company's personnel was on average
36 (41 in 2006) and at the end of the period 36 (35 on 31.12.2006).
Shareholders' meetings held during the financial year
The Annual General Meeting of Biotie Therapies Corp. was held on
March 28, 2007.
The General Meeting of Shareholders adopted the income statement and
balance sheet including the consolidated income statement and balance
sheet for the financial year 1 January 2006-31 December 2006. The
General Meeting of Shareholders resolved pursuant to the proposal of
the Board of Directors that the loss of the financial year, EUR
8,021,230.19 shall be transferred to the company's equity.
The General Meeting of Shareholders discharged the members of the
Board of Directors and the President and CEO from liability
concerning the financial year from 1 January-31 December 2006.
The number of the members of the Board of Directors was resolved to
be four. Juha Jouhki, Pauli Marttila, Riku Rautsola and Piet Serrure
were re-elected as the members of the Board of Directors. Janne
Rajalahti, Authorized Public Accountant, and PricewaterhouseCoopers
Oy, Authorized Public Accountants, were elected as auditors of Biotie
Therapies Corp.
At the organization meeting of the Board of Directors, convened
immediately after the Annual General Meeting, Juha Jouhki was elected
as the Chairman of the Board of Directors and Pauli Marttila as the
deputy chairman.
The General Meeting resolved pursuant to the proposal of the Board of
Directors to amend the Articles of Association to better correspond
to the Finnish Companies Act entered into force on 1 September 2006.
The Meeting resolved on the following amendments:
a) Removal of regulations concerning the amount and range of the
share capital (Article 4).
b) Removal of the statement regarding the tasks of the Board of
Directors in the management of the company and the statement that a
quorum requires the attendance of either the Chairman or the Vice
Chairman (Article 5)
c) Removal of the description of the President and CEO's function
(Article 6).
d) The right to sign for the company was changed to the right of
representation as set forth in the Finnish Companies Act currently in
force and removal of the statement how the Board of Directors may
grant rights to sign for the company. It is noted that the Company is
represented by the Chairman of the Board of Directors and the
Managing Director, each alone, and two members of the Board of
Directors together (Article 7).
e) Section which concerns the presentation of the financial
statements at the Annual General Meeting of Shareholders was amended
so that the financial statements containing the consolidated
financial statements and the annual report, which no longer is a part
of the financial statements, will be presented at the meeting
(Article 12).
f) The wording of the section concerning the adoption of the
financial statements was amended so that according to it the General
Meeting of Shareholders shall adopt the financial statements and the
consolidated financial statements instead of the previous income
statement and balance sheet and the consolidated income statement and
balance sheet (Article 12).
The General Meeting resolved pursuant to the proposal of the Board of
Directors to amend the terms and conditions of the company's
convertible capital loan of 2004. Further, the General Meeting
resolved to amend the terms and conditions of the 2004 and 2006
option programmes. The references in terms of both the convertible
capital loan and option programmes to terms and practices under the
former Finnish Companies Act, which after the amendment of the Act
and the Company's Articles of Association no longer are necessary,
will be removed. Further, the reference to measures to be taken
pursuant to option rights in the reduction of the share capital was
amended to correspond to the Finnish Companies Act in force.
Furthermore, the terms and conditions were amended so that the
subscription price of the shares both according to the terms and
conditions of the convertible capital loan and the options may be
recorded in the fund for invested non-restricted equity.
The General Meeting authorised the Board of Directors to make other
corresponding amendments to the terms and conditions of the
convertible capital loan and option programmes without changing the
number of shares to be subscribed for pursuant to the convertible
capital loans or option rights or any other material terms and
conditions.
The General Meeting authorised the Board of Directors to resolve on
the issuance of the maximum of 18,000,000 new shares in one or
several instalments in a share issue or on the issuance of options or
other special rights to the shares. The authorisation entitles the
Board of Directors to deviate from the shareholders' pre-emptive
subscription right. The authorisation is effective until 30 June
2008.
The ten biggest shareholders of BioTie on 31 March, 2007
Number of shares %
Finnish Innovation Fund (Sitra) 14 585 350 16.41
Finnish Industry Investment Ltd 9 378 707 10.55
Juha Jouhki and his controlled companies 6 537 672 7.36
- Dreadnought Finance Oy (2 098 416)
- Jouhki Juha (1 501 356)
- Thominvest Oy (2 937 900)
Funds administered by BioFund Management Oy: 2 518 775 2.83
- BioFund Ventures III Ky (2 485 715)
- BioFund Ventures I Ky (33 060)
Oy H. Kuningas & Co AB 1 058 371 1.19
Tilator Oy 676 264 0.76
Funds administered by Aboa Venture Management
Oy: 634 666 0.71
- Aboa Venture Ky I (282 142)
- Aboa Venture Ky II (336 747)
- Ganal Venture Ky (7 906)
- Karhu Pääomarahasto Ky (7 871)
Markkula Harri 586 301 0.66
Oksanen Markku 559 300 0.63
Lassila Markus 355 734 0.40
36 891 140 41.51
Nominee registered shares total 25 477 064 28.67
Other shareholders 26 499 856 29.82
Outstanding shares 88 868 060 100.00
The number of the company's own shares held
by Biotie Therapies 662 600
Total 89 530 660
Events after the reporting period
After the reporting period BioTie gained knowledge on April 2, 2007
of the following notification under Chapter 2, Section 9 of the
Finnish Securities Market Act regarding a change in holdings:
Finnish Industry Investment Ltd (Business identity code 1007806-3)
has informed the company the holdings of Finnish Industry Investment
Ltd represent less than one tenth (1/10) of the voting rights and
share capital in Biotie Therapies Corp.
The holdings of Finnish Industry Investment Ltd constitute 8.702.189
shares, i.e., 9.72 % of the voting rights and share capital in Biotie
Therapies Corp.
BioTie gained knowledge on April 4, 2007 of the following
notification under Chapter 2, Section 9 of the Finnish Securities
Market Act regarding a change in holdings on 30 March 2007:
The aggregate holding of Pequot Healthcare Fund, L.P., Pequot
Healthcare Offshore Fund, Inc., Premium Series PCC Limited - Cell 32,
Pequot Diversified Master Fund, Ltd., Pequot Healthcare Institutional
Fund, L.P. and Pequot Healthcare Emerging Markets Fund, Ltd.
(jointly, the "Funds") have increased from 23.16 % to 25.76 % of the
share capital and voting rights of the Company, calculated on the
basis of the number of shares registered in the Finnish Trade
Register on 4 April 2007. No individual Fund has decreased its
holding below or above 5 % of the voting rights and share capital in
the Company.
IFRS and Accounting principles
BioTie adopted International Financial Reporting Standards (IFRS)
starting from 1.1.2005. 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
2005.
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, 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
Decision from the UK Medicines and Healthcare products Regulatory
Authority (MHRA) on the marketing authorisation for nalmefene in the
UK is expected in the second half of 2007.
Fully human VAP-1 monoclonal antibody program is expected to enter
into clinical development phase during the first half 2007.
FINANCIAL STATEMENT
1.1.-31.03.2007 1.1.-31.03.2006 1.1.-31.12.2006
EUR 1,000
3 months 3 months 12 months
Revenue 605 249 1,118
Research and -1,475 -1,798 -7,970
Development expenses
General and -597 -881 -2,207
administrative
expenses
Other operating 258 266 698
income
Operating profit -1,209 -2,163 -8,361
(loss)
Financial income 302 41 215
Financial expenses -211 -187 -812
Profit (loss) before -1,119 -2,310 -8,958
taxes
Taxes 0 0 -7
Net income (loss) -1,119 -2,310 -8,964
Distribution
To parent company -1,119 -2,310 -8,964
Shareholders
Earnings per share -0.01 -0.04 -0.16
(EPS) basic and
diluted, EUR
BALANCE SHEET
EUR 1,000 31.03.2007 31.03.2006 31.12.2006
Assets
Non-current assets
Intangible assets 787 971 801
Property, plant and equipment 96 150 109
Financial assets at fair value 20,000 0 20,000
through
profit or loss
20,883 1,120 20,910
Current assets
Current receivables 713 746 560
Financial assets at fair value 9,168 5,926 7,878
through
profit or loss
Cash and cash equivalents 274 316 3,886
10,155 6,988 12,323
Total 31,038 8,108 33,233
Equity and liabilities
Shareholders' equity
Share capital 19,850 1,054 19,850
Retained earnigs -30,638 -20,588 -21,692
Net income (loss) -1,119 -2,310 -8,964
Shareholders' equity total -11,907 -21,845 -10,807Long-term liabilities
Provisions 23 36 27
Interest-bearing liabilities 23,508 22,572 23,508
Non-interest-bearing liabilities 6,310 4,867 6,528
29,840 27,474 30,063
Current liabilities
Provisions 16 16 16
Interest-bearing liabilities 18 32 27
Accounts payable and other debts 13,071 2,430 13,934
13,105 2,478 13,977
Liabilities total 42,945 29,953 44,040
Total 31,038 8,108 33,233
Statement of Changes in Shareholders' Equity
Parent company shareholders' equity Share-holders'
equity
total
EUR 1,000 Shares Share Share Own Retained
(1000 capital premium shares earnings
pcs) fund
Balance at 52,675 1,054 5,881 -15 -26,502 -19,583
1.1.2006
Net income -2,310 -2,310
(loss)
for the period
Options granted 49 49
Transfer from -5,881 5,881 0
share
premium fund
0 0 -5,881 0 3,619 -2,261
BALANCE AT 52,675 1,054 0 -15 -22,883 -21,845
31.03.2006
Net income -6,654 -6,654
(loss)
for the period
Options granted 53 53
Share issue 36,855 18,796 -1,157 17,639
36,855 18,796 0 0 -7,758 11,038
BALANCE AT 89,531 19,850 0 -15 -30,641 -10,807
31.12.2006
Net income -1,119 -1,119
(loss) for the
period
Options granted 19 19
0 0 0 0 -1,045 -1,100
BALANCE AT 89,531 19,850 0 -15 -31,686 -11,907
31.03.2007
CASH FLOW STATEMENT
1.1.-31.03.2007 1.1.-31.03.2006 1.1.-31.12.2006
EUR 1,000 3 months 3 months 12 months
Cash flow from
operating activities
Net income (loss) -1,119 -2,310 -8,964
Adjustments:
Non-cash transactions 52 170 1,249
Addition/disposal -257 -27 -84
due to revaluation
of financial assets
at fair value
through profit or
loss
Interest expenses 211 187 812
and other financial
Expenses
Interest income -302 -41 -215
Taxes 0 0 7
Change in working
capital:
Change in trade and -153 -169 -19
other
receivables
Change in trade -1,072 -18 12,535
creditors and other
Liabilities
Change in mandatory 4 -4 -12
provisions
Interests paid -5 -6 -25
Interests received 45 11 131
Taxes paid 0 0 -7
Net cash from -2,595 -2,206 5,408
operating activities
Cash flow from
investing activities
Change in financial
assets at fair
value through profit
or loss
Additions -2,000 0 -25,000
Disposals 1,000 800 4,000
Investments to -7 -3 -819
tangible assets
Sale of associated 0 45 45
companies
Net cash used in -1,007 842 -21,773
investing activities
Cash flow from
financing activities
Payments from share 0 0 17,639
issue
Proceeds from 0 1,302 2,232
borrowings
Repayment of lease -10 -17 -15
Commitments
Net cash from -10 1,285 19,856
financing activities
Net increase (+) or -3,611 -79 3,490
decrease (-) in
cash and cash
equivalents
Cash and cash 3,886 395 395
equivalents in the
beginning of the
period
Cash and cash 274 316 3,886
equivalents in the
end of the period
KEY FIGURES
1.1.-31.03.2007 1.1.-31.03.2006 1.1.-31.12.2006
EUR 1,000 3 months 3 months 12 months
Business development
Revenues 605 249 1,118
Personnel on average 36 41 37
Personnel at the end 36 37 35
of period
Research and 1,475 1,798 7,970
development costs
Capital expenditure 7 3 819
Profitability
Operating profit -1,209 -2,163 -8,361
(loss)
as percentage of -198.9 -868.3 -747.6
revenues, %
Profit (loss) before -1,119 -2,310 -8,958
taxes
as percentage of -185.0 -927.2 -800.9
revenues, %
Balance sheet
Cash and cash 29,442 6,241 31,763
equivalents
Shareholders equity -11,907 -21,845 -10,807
Balance sheet total 31,038 8,108 33,233
Financial ratios
Return on equity, % - - -
Return on capital -29.8 -680.9 -113.5
employed, %
Equity ratio, % -56.6 -269.4 -46.5
Gearing, % 49.7 -74.9 76.1
Per share data
Earnings per share -0.01 -0.04 -0.16
(EPS), EUR
Shareholders'equity -0.13 -0.41 -0.12
per share, EUR
Divided per share,
EUR
Pay-out ratio, %
Effective dividend
yield, %
P/E-ratio
Share price
Lowest share price, 0.85 0.49 0.49
EUR
Highest share 1.18 0.70 2.39
price, EUR
Average share 1.01 0.57 1.10
price, EUR
31.3.2007 share 0.89 0.58 1.18
price, EUR
Market 79.7 30.6 105.6
capitalization, MEUR
Trading of shares
Number of shares 14,390,615 4,578,627 32,470,230
traded
As percentage of all 16.1 8.7 36.3
Adjusted weighted 89,530,660 52,675,221 54,995,830
average
number of shares
during the period,
Adjusted number of 89,530,660 52,675,221 89,530,660
shares at the end
of the period
Contingent liabilities
EUR 1,000 31.03.2007 31.03.2006 31.12.2006
Lease commitments 104 135 73
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: Helsinki Stock Exchange
Main Media
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