2008-08-08 08:00:00 CEST
2008-08-08 08:00:36 CEST
SÄÄNNELTY TIETO
Biotie Therapies - Interim report (Q1 and Q3)
Interim Report on Biotie Therapies Corp. January 1 - June 30, 2008
BIOTIE THERAPIES CORP. STOCK EXCHANGE RELEASE August 8, 2008 at
9.00 a.m.
INTERIM REPORT ON BIOTIE THERAPIES CORP. JANUARY 1 - JUNE 30, 2008
January - June 2008 in brief
- In January Lundbeck acquired the United Kingdom and Ireland rights
for nalmefene from Britannia Pharmaceuticals (now part of STADA
Group, headquartered in Germany). Following the new agreement
Lundbeck has worldwide rights for nalmefene, excluding North America,
Mexico, Turkey, and South-Korea.
- In June Biotie announced top-line data from the first-in-man
clinical study with its fully human VAP-1 monoclonal antibody. The
data from the study support proceeding to clinical studies with
repeated doses of the antibody.
- The net loss in January - June stood at EUR 3.3 million (net income
in 2007 EUR 1.6 million). Cash flow in January - June from operating
activities was EUR -5.8 million (EUR -2.9 million in 2007).
- Revenue for January - June stood at EUR 3.2 million (EUR 5.2
million in 2007) and earnings per share was EUR -0.04 (EUR 0.02 in
2007).
- The company's liquid assets amounted to EUR 23.0 million as at June
30, 2008 (EUR 30.2 million as at June 30, 2007).
Q2/2008 in brief:
- The net loss in April - June stood at EUR 1.3 million (net income
in 2007 EUR 2.7 million). Cash flow in April - June from operating
activities was EUR -2.5 million (EUR -0.3 million in 2007).
- Revenue for April - June stood at EUR 1.8 million (EUR 4.6 million
in 2007) and earnings per share was EUR -0.01 (EUR 0.03 in 2007).
General:
Biotie is a drug development company focusing on dependence
disorders, inflammatory diseases and thrombosis.
Drug development projects:
Nalmefene program
In January, Lundbeck acquired the United Kingdom and Ireland rights
for nalmefene from Britannia Pharmaceuticals (now part of STADA
Group, headquartered in Germany). Following the new agreement
Lundbeck has worldwide rights for nalmefene, excluding North America,
Mexico, Turkey, and South-Korea.
Biotie-Lundbeck license agreement terms were amended due to Lundbeck
acquiring the United Kingdom and Ireland rights. Under the terms of
the amended agreement, Biotie is now eligible for up to EUR 82
million in upfront and milestone payments (previously up to EUR 80
million) plus royalty on sales. Of the EUR 82 million, Biotie has
already received an execution fee of EUR 12 million from Lundbeck.
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. Biotie will participate in
financing some of the clinical development costs.
VAP-1 antibody program
Top-line data from the first-in-man study with Biotie's fully human
VAP-1 monoclonal antibody BTT-1023 were reported in June 2008. The
study was conducted in a clinical pharmacology unit in the United
Kingdom and investigated the safety, tolerability and pharmacokinetic
characteristics of single intravenous doses of BTT-1023 in healthy
volunteer subjects.
A total of 35 subjects, of whom 29 received BTT-1023, were enrolled
into the placebo-controlled study. BTT-1023 was generally well
tolerated and no serious adverse events were reported in the study.
Among the five subjects who received the highest dose, facial
flushing was reported by two subjects with accompanying facial oedema
in one of the two. These were reported during or shortly after the
infusion and are not uncommon events in association with intravenous
administration of therapeutic protein drugs. No cytokine release or
fever was observed in any subject. All adverse events were fully
reversible and required no particular intervention.
The data from the study support proceeding to clinical studies with
repeated doses of the antibody. These studies are expected to be
carried out in rheumatoid arthritis and psoriasis patients and will
aim to establish appropriate dosing regimens for subsequent
therapeutic studies and provide initial information on the
therapeutic potential of BTT-1023. The studies are expected to start
in the end 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 has paid 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 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.
Co-operation with Seikagaku Corporation proceeded as planned.
Pre-clinical programs
Pre-clinical programs (VAP-1 SSAO small molecule inhibitor program
and alfa2beta1 integrin inhibitor program) progressed as planned. In
the bioheparin program the company continued to look for a partner to
finance the future development of the program. To date, partnering
efforts have not been successful.
Revenues
Revenue for the reporting period 1.1.-30.6.2008 was EUR 3.2 million.
Revenue consisted of periodization of the signing fees of the
licensing agreements signed with Seikagaku Corporation in 2003 and
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. No new milestones
or signing fees were received during the reporting period.
Revenue for the period 1.1.-30.6.2007 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 as well as periodization
of the execution fee of the licensing agreement signed with Lundbeck
that entered into force in May 2007. The revenue was in total EUR 5.2
million. Payment of EUR 2.0 million was received from Lundbeck during
the period.
Revenue for April - June 2008 amounted to EUR 1.8 million (EUR 4.6
million in 2007) consisting of periodizations described above.
Financial results
The net loss for the reporting period was EUR 3.3 million (net income
in 2007 EUR 1.6 million). Research and development costs for the
period amounted to EUR 5.2 million. The corresponding figure for the
previous year was EUR 3.5 million.
The net loss in April - June was EUR 1.3 million (net income in April
- June 2007 EUR 2.7 million). Research and development costs in the
second quarter amounted to EUR 2.8 million (EUR 2.1 million in 2007)
Patent costs have been booked as expenses.
Financing
Biotie's equity ratio was -57.6 % on June 30, 2008 (-25.5 % in 2007).
Cash and cash equivalents totaled EUR 23.0 million on June 30, 2008
(EUR 30.2 million in 2007).
The company has invested its liquid assets into bank deposits during
the second quarter 2008. Funds are reported in "investments held to
maturity". Deposits with maturity less than 3 months are reported in
the "cash and cash equivalents". Previously the funds were invested
in money market funds.
In January 2008, The Finnish Funding Agency for Technology and
Innovation (Tekes) granted EUR 1.7 million additional funding for
Biotie Therapies' integrin alpha2beta1 inhibitor program for
thrombosis. The R&D funding granted covers drug development costs of
the project from July 2007 to December 2009.
The funding granted is in the form of loan and it covers 50 per cent
of the costs of the project. The loan will be paid to Biotie against
reported realised costs. In order to receive the full amount of
granted financing, Biotie must show a total expenditure of EUR 3.4
million in the project.
Shareholder's equity
The shareholders' equity (FAS) of the company is less than half of
the company's share capital when capital loans are not included in
shareholders' equity. Shareholders' equity and capital loans add up
to EUR 14.3 million.
Annual General Meeting was held on March 28, 2008 and considered
measures relating to the level of shareholder's equity. It was
resolved that no special measures are necessary at this point in
time.
Investments and cash flow
The cash flow from operations was EUR -5.8 million (in 2007 EUR -2.9
million The company's investments during the reporting period
amounted to EUR 109 thousand (EUR 10 thousand in 2007).
The cash flow from operating activities in April - June was EUR -2.5
million (EUR -0.3 million in 2007). Investments during the second
quarter amounted to EUR 92 thousand (EUR 3 thousand in 2007).
Personnel
During the reporting period, the company's personnel was on average
35 (35 in 2007, 39 in 2006) and at the end of the reporting period 36
(33 on June 30, 2007 and 36 on June 30, 2006).
The ten biggest shareholders of Biotie on June 30, 2008
Number of
shares %
Pequot group: 21,069,624 23.55
- 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.
(3,644,600)
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: 2,519,775 2.82
- BioFund Ventures III Ky (2,485,715)
- BioFund Ventures I Ky (34,060)
Harri Markkula and his controlled company: 1,316,695 1.47
- Tilator Oy (420,700)
- Markkula Harri (895,995)
Oy H. Kuningas & Co AB 1,058,371 1,18
Oksanen Markku 690,00 0.77
Sij.rahasto ABN Amro small cup 550,000 0.61
Siven Pertti 350,000 0.39
55,456,079 61,99
Nominee registered shares total 6,075,001 6.79
Other shareholders 27,931,780 31.22
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
*) The company has in its possession 819.000 of its own shares.
Relating to the company's option programs, the company has signed a
stock lending agreement with EVLI Bank in January, 2007. Pursuant to
this program, the number of the company's own shares in its
possession may be temporarily less than 819,000.
Short-term risks and uncertainties
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 and availability of capital. 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
- Lundbeck is expected to start additional phase III studies with
nalmefene in its alcohol indication in 2008.
- Due to Biotie having two programs in the clinical development phase
the operating costs are expected to increase to a somewhat higher
level for 2008 than in 2007.
- Revenue in 2008 is estimated to be approximately EUR 5 to 6 million
and consists of periodization of already received payments based on
established revenue recognition principles. The company is not
expecting new milestone payments based on existing agreements in
2008.
IFRS and Accounting principles
The interim report has been prepared in accordance with IAS 34,
Interim Financial Reporting. Biotie has applied the same accounting
principles as in the closing of year 2007.
This interim report is unaudited.
Biotie's interim report for January - September will be published on
October 24, 2008.
In Turku, August 8, 2008
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
Main Media
APPENDICES TO THE FINANCIAL STATEMENTS
Income statement
Balance sheet
Statement of changes in shareholders' equity
Cash flow statement
Key figures
FINANCIAL
STATEMENT
1.4.- 1.4.- 1.1.- 1.1.- 1.1.-
30.6.2008 30.6.2007 30.6.2008 30.6.2007 31.12.2007
EUR 1,000 3 months 3 months 6 months 6 months 12 months
Revenue 1,838 4,605 3,159 5,210 7,895
Research and -2,797 -2,074 -5,200 -3,549 -9,053
development
expenses
General and -424 -366 -899 -963 -1,655
administrative
expenses
Other operating 61 426 120 684 1,044
income
Operating -1,322 2,592 -2,820 1,383 -1,769
profit/loss
Financial income 231 299 235 601 860
Financial expenses -191 -190 -717 -401 -817
Profit/loss before -1,282 2,702 -3,302 1,583 -1,726
taxes
Taxes 0 0 0 0 0
Net income/loss -1,282 2,702 -3,302 1,583 -1,726
Distribution
To parent -1,282 2,702 -3,302 1,583 -1,726
company
Shareholders
Earnings per share -0.01 0.03 -0.04 0.02 -0.02
(EPS)
basic &
diluted, EUR
BALANCE SHEET
EUR 1,000 30.6.2008 30.6.2007 31.12.2007
Assets
Non-current assets
Intangible assets 720 774 747
Property, plant and equipment 370 84 332
Financial assets at fair value 0 20,000 14,938
through
profit or loss
1,090 20,858 16,017
Current assets
Accounts receivables and other 726 1,031 753
receivables
Investments held to maturity 17,500 0 0
Financial assets at fair value through 0 9,302 13,000
profit or loss
Cash and cash equivalents 5,504 936 305
23,730 11,270 14,058
Total 24,820 32,128 30,075
Equity and liabilities
Shareholders' equity
Share capital 19,850 19,850 19,850
Reserve for invested unrestricted 980 980 980
equity
Retained earnings -31,832 -30,619 -30,220
Net income/loss -3,302 1,583 -1,726
Shareholders' equity total -14,304 -8,207 -11,117
Non-current liabilities
Provisions 3 19 14
Non-current financial liabilities 24,538 23,350 23,603
Other non-current liabilities 8,628 14,071 10,098
33,169 37,440 33,715
Current liabilities
Provisions 20 16 20
Current financial liabilities 143 15 104
Accounts payable and other current 5,791 2,864 7,353
debts
5,955 2,895 7,477
Liabilities total 39,124 40,335 41,192
Total 24,820 32,128 30,075
STATEMENT OF CHANGES IN SHAREHOLDERS' EQUITY
Attributable to equity holders of the parent company
EUR 1,000 Shares Share Reserve Own Retained Share-
(1000 Capital For Shares Earnings holders'
pcs) invested equity
Un- total
restricted equity
Balance at 89,531 19,850 0 -15 -30,641 -10,807
1.1.2007
Net income/loss 1,583 1,583
for the period
Options granted 38 38
Share subscription 450 841 841
with
Convertible
capital loans
Share subscription 231 139 139
with
Option rights
681 0 980 0 1,621 2,600
BALANCE AT 90,212 19,850 980 -15 -29,020 -8,207
30.6.2007
Net income/loss -3,309 -3,309
for the period
Options granted 399 399
0 0 0 0 -2,910 -2,910
BALANCE AT 90,212 19,850 980 -15 -31,930 -11,117
31.12.2007
Net income/loss -3,302 -3,302
for the period
Options granted 115 115
0 0 0 0 -3,187 -3,187
BALANCE AT 90,212 19,850 980 -15 -35,117 -14,304
30.6.2008
CASH FLOW STATEMENT
1.1.- 1.1.- 1.1.-
30.6.2008 30.6.2007 31.12.2007
EUR 1,000 6 months 6 months 12 months
Cash flow from operating
Activities
Net income/loss -3,302 1,583 -1,726
Adjustments:
Non-cash transactions 240 99 443
Addition/disposal due to 0 -517 -644
revaluation
of financial assets at fair
value through profit or loss
Interest expenses and other 717 401 817
financial expenses
Interest income -235 -601 -216
Taxes 0 0 0
Change in working capital:
Change in accounts receivables and 245 -448 -190
other receivables
Change in accounts payable and -3,499 -3,507 -3,799
other liabilities
Change in mandatory provisions -10 8 10
Interests paid -2 -10 -40
Interests received 31 85 57
Taxes paid 0 0 0
Net cash from operating activities -5,815 -2,908 -5,288
Cash flow from investing
activities
Change in financial assets at
fair value through profit or loss
Additions 0 -3,000 -4,500
Disposals 27,685 2,154 5,280
Change in investments held to maturity
Additions -22,500 0 0
Disposals 5,000 0 0
Investments to tangible assets -27 -10 -23
Net cash used in investing 10,158 -856 757
activities
Cash flow from financing
activities
Payments from share issue 0 139 139
Proceeds from borrowings 888 689 874
Repayment of loans 0 0 -40
Repayment of lease -32 -12 -23
commitments
Net cash from financing 856 815 950
activities
Net increase (+) or decrease (-) 5,199 -2,949 -3,581
in cash and cash equivalents
Cash and cash equivalents in the 305 3,886 3,886
beginning of the period
Cash and cash equivalents in the 5,504 936 305
end of the period
KEY FIGURES
1.1.- 1.1.- 1.1.-
30.6.2008 30.6.2007 31.12.2007
EUR 1,000 6 months 6 months 12 months
Business
development
Revenues 3,159 5,210 7,895
Personnel on average 35 35 36
Personnel at the end of period 36 33 37
Research and development costs 5,200 3,549 9,053
Capital expenditure 109 10 287
Profitability
Operating profit/loss -2,820 1,383 -1,769
as percentage of revenues, % -89.3 26.5 -22.4
Profit/loss before taxes -3,302 1,583 -1,726
as percentage of revenues, % -104.5 30.4 -21.9
Balance sheet
Cash and cash equivalents 23,004 30,239 28,243
Shareholders equity -14,304 -8,207 -11,117
Balance sheet total 24,820 32,128 30,075
Financial ratios
Return on equity, % - - -
Return on capital employed, % -45.0 28.4 -7.2
Equity ratio, % -57.6 -25.5 -37.0
Gearing, % -11.7 83.8 40.8
Per share data
Earnings per share (EPS) basic & -0.04 0.02 -0.02
diluted, EUR
Shareholders'equity per share, EUR -0.16 -0.09 -0.12
Dividend per share, EUR
Pay-out ratio, %
Effective dividend yield, %
P/E-ratio
Share price
Lowest share price, EUR 0.50 0.85 0.75
Highest share price, EUR 0.94 1.18 1.22
Average share price, EUR 0.70 0.99 0.98
End of period share price, EUR 0.53 0.91 0.76
Market capitalization 47.8 82.1 68.6
at the end of period MEUR
Trading of shares
Number of shares traded 7,103,973 25,749,500 35,093,743
As percentage of all 7.9 28.5 38.9
Adjusted weighted average 90,211,860 89,661,658 90,003,192
Number of shares during the period
Adjusted number of shares 90,211,860 90,211,860 90,211,860
at the end of the period
Related party transactions
There have not been material changes within the related party
transactions in 2008.
Contingent liabilities
EUR 1,000 30.6.2008 30.6.2007 31.12.2007
Lease 152 29 159
commitments
Formulas for the Calculation of the Financial Ratios
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 outstanding shares at the end of the
period
© 2024 Nasdaq, Inc. All Rights Reserved |
| Evästeet |