Transgene Announces Second Quarter and First Half 2004 Financial Results
04 Agosto 2004 - 12:01AM
PR Newswire (US)
Transgene Announces Second Quarter and First Half 2004 Financial
Results STRASBOURG, France, Aug. 4 /PRNewswire-FirstCall/ --
Transgene (Nasdaq: TRGNY; Nouveau Marche: FR0005175080) today
announced financial results for the second quarter ended June 30,
2004. Transgene had total revenues of euro 0.4 million (US$ 0.5
million) in the second quarter of 2004, the same as for the second
quarter of 2003. For the first six months of 2004, revenues were
euro 1.0 million (US$ 1.2 million), compared to euro 1.3 million
(US$ 1.6 million) for the same period in 2003. In the first quarter
of 2003, Transgene recorded the upfront payment related to the
license agreement signed with Merck & Co., Inc. After
completion of quality controls, revenues from the EUROVAC
manufacturing work performed in the second quarter 2004 are
expected to be recognized in the second half of 2004. Operating
expenses decreased by euro 0.2 million (US$ 0.2 million) to euro
5.7 million (US$ 6.9 million) for the second quarter of 2004
compared to euro 5.9 million (US$ 7.2 million) for the second
quarter of 2003. Clinical expenses were lower due to a decrease in
the number of patients recruited in the second quarter of 2004
compared to the same period in 2003. Patient recruitment is now
complete for most of the on-going Phase II clinical trials. General
and administrative costs also decreased by euro 0.1 million (US$
0.1 million). For the first six months of 2004, operating expenses
were unchanged at euro 12.0 million (US$ 14.6 million). Interest
and other income was euro 0.1 million (US$ 0.1 million) in the
second quarter 2004 compared to euro 0.3 million (US$ 0.4 million)
in the same period of 2003, due to lower cash and cash equivalent
held and lower interest rates. Transgene recorded a net loss of
euro 5.1 million (US$ 6.2 million), or euro 0.51 (US$ 0.62) per
share, for the second quarter of 2004 compared to a net loss of
euro 5.2 million (US$ 6.3 million), or euro 0.51 (US$ 0.62) per
share for the same period in 2003. The net loss for the first six
months ended June 30, 2004 was euro 10.7 million (US$ 13 million)
or euro 1.06 (US$ 1.29) per share, compared to euro 10.0 million
(US$ 12.2 million), or euro 0.99 (US$ 1.21) per share for the same
period of 2003. Net cash expenditures were euro 10.2 million (US$
12.4 million) for the first six months of 2004, resulting in cash
and cash equivalents totaling euro 24.8 million (US$ 30.2 million)
at June 30, 2004. Transgene believes that this amount will be
sufficient to meet its cash requirements for working capital and
capital expenditures through mid-2005. First Half 2004 Highlights *
Transgene released positive interim data in three phase II trials
with the MVA-MUC1-IL2 cancer vaccine candidate in patients with
lung, kidney and prostate cancer. In lung cancer, the interim
results indicate that 12 out of 18 patients have benefited from the
combination of MVA-Muc1-IL2 vaccination with chemotherapy. In the
sub-group of metastatic disease (14 patients with stage IV), 11
patients (79%) showed clinical benefit (partial and stable
diseases). Results from the ongoing stage 2 of the study are
expected in the coming months. In the prostate trial, the interim
results showed that the vaccination with MVA-MUC1-IL2 is
biologically active and may decelerate the progression of the
disease. In kidney, enrollment in this 36-patient study proceeded
quickly and has now completed. Nine out of 21 evaluable patients
have had stable disease and continued their treatment with
MVA-Muc1-IL2 monotherapy. Further data will be available in the
coming months. * Transgene released positive data from the phase II
trial with the MVA-HPV-IL2 cancer vaccine candidate in patients
with human papilloma virus (HPV)-related disease, demonstrating
dose-related effect and safety at the highest dose given. *
Transgene manufactured clinical lots of HIV vaccine candidates in
the frame of EUROVAC (European Vaccine Effort against HIV/AIDS), a
European cluster of 21 laboratories, funded since 2000 by the
European Union under the 5th Framework Programme. * Transgene and
Merial Limited announced a collaboration to develop products for
animal health indications using Transgene's vector platform. Under
the terms of the agreement, Transgene will provide Merial with
research and development support regarding vector-based expression
of certain genes selected by Merial. Transgene, based in
Strasbourg, France, is a biopharmaceutical company dedicated to the
discovery and development of therapeutic vaccines, immunotherapy
products, and delivery technologies for the treatment of diseases
for which there is no cure or adequate treatment at present, with a
focus on the treatment of cancer. Transgene has five products in
clinical development, two of which are in Phase II clinical trials,
two in Phase I/II and one that has completed Phase I clinical
trial. Transgene's proprietary vector technology platform consists
of adenovirus and poxvirus. This press release contains
forward-looking statements, including statements regarding
Transgene's revenues, capital requirements, manufacturing
capabilities and prospects. Statements that are not historical
facts are based on Transgene's current expectations, beliefs,
estimates, forecasts and assumptions. The statements contained in
this release are not guarantees of future performance and involve
certain risks, uncertainties and assumptions which are difficult to
predict. Accordingly, actual outcomes and results may differ
materially from what is expressed in those forward-looking
statements. Important factors which may affect Transgene's future
operating results include the following: Transgene has a history of
operating losses; it may not have sufficient resources or may fail
to obtain the capital necessary to complete the research and
commercialization of any of its product candidates; Transgene may
be unable to conduct its clinical trials as quickly as it has
predicted; Transgene's clinical trials may not produce results
sufficient to justify further product development; Transgene's
product candidates may not demonstrate therapeutic efficacy;
Transgene's products are in early stage clinical trials and the
favorable results of some of the trials may not be indicative of
broader results for a large number of humans; Transgene may be
unable to obtain regulatory approval for its product candidates;
Transgene's patent and proprietary rights may not provide it with
any benefit and the patents of others may prevent it from
commercializing its products; proceedings to obtain patents and
litigation of third party infringement claims are expensive and
could limit its patent and proprietary rights; competitors may
develop technologies or products superior to Transgene's
technologies or products; and other important factors described in
Transgene's Annual Report on Form 20-F for the most recent fiscal
year filed with the U.S. Securities and Exchange Commission,
including those factors described in the section entitled "Risk
Factors." Note: The official financial information of Transgene is
stated in Euros. The financial information expressed in US$ is
translated solely for the convenience of the reader at euro 1.00 =
$ 1.2179, the noon buying rate of the Federal Reserve Bank of New
York on June 30, 2004. Condensed Consolidated Balance Sheets (US
GAAP) (Amounts in thousands) June 30, December 31, 2004 2004 2003
US$ euro euro (Unaudited) (Audited) ASSETS Cash and cash
equivalents 30 192 24 790 34 940 Other current assets 2 457 2 017 2
522 32 648 26 807 37 462 Property, plant and equipment, net 9 301 7
637 8 034 Other assets 391 321 322 42 340 34 765 45 818 LIABILITIES
AND SHAREHOLDERS' EQUITY Total current liabilities 5 937 4 875 5
301 Total long-term liabilities 7 211 5 921 5 998 Total
shareholders' equity 29 192 23 969 34 519 42 340 34 765 45 818
Condensed Consolidated Statements of Operations US GAAP (Amounts in
thousands except share and per share data) Three months ended June
30, Six month ended June 30, 2004 2004 2003 2004 2004 2003 US$ euro
euro US$ euro euro (Unaudited) (Unaudited) Revenues Revenues from
collaborative and licensing agreements 529 434 423 1 202 987 1 319
Grants received for research and development 0 0 0 0 0 0 Total
revenues 529 434 423 1 202 987 1 319 Operating expenses Research
and devel- opment (5 683) (4 666) (4 725) (12 279) (10 082) (9 899)
General & administra- tive (1 236) (1 015) (1 146) (2 290) (1
880) (2 065) Restructuring 0 0 0 0 0 0 Total opera- ting expenses
(6 919) (5 681) (5 871) (14 569) (11 962) (11 964) Loss from opera-
tions (6 390) (5 247) (5 448) (13 367) (10 975) (10 645) Interest
and other income, net 166 136 289 415 341 646 Income tax benefit
(21) (17) 0 (21) (17) 0 Net loss (6 245) (5 128) (5 159) (12 972)
(10 651) (9 999) Loss per ordinary share (0.62) (0.51) (0.51)
(1.29) (1.06) (0.99) Weighted average number of shares outstand-
ing 10 055 760 10 055 760 10 055 760 10 055 760 10 055 760 10 055
760 Loss per ADS (American Depositary Share) (0.21) (0.17) (0.17)
(0.43) (0.35) (0.33) Weighted average number of ADSs outstand- ing
30 167 280 30 167 280 30 167 280 30 167 280 30 167 280 30 167 280
Notes: The official financial information of Transgene is stated in
Euros. The financial information expressed in US$ is translated
solely for the convenience of the reader at euro 1.00 = $ 1.2179,
the noon buying rate of the Federal Reserve Bank of New York on
June 30, 2004. The 2003 accounts have been restated to SFAS 123
"Accounting for Stock based Compensation." During the second
quarter of 2004, Transgene reviewed revenue recognition from a
certain manufacturing contract and concluded that the euro 0.653
million revenues reported in the first quarter of 2004 should be
reduced by euro 0.100 million, down to euro 0.553 million. As a
result of this change, net loss should be euro 5.523 million,
compared to the previously reported euro 5.423 million.
Consolidated balance sheet and statement of operations for the
quarter ended March 31, 2004 have been restated accordingly, as
shown below: Condensed Consolidated Balance Sheets (US GAAP)
(Amounts in thousands ) March 31, 2004 2004 US$ euro (Unaudited)
ASSETS Cash and cash equivalents 36 404 29 616 Other current assets
3 059 2 489 Total current assets 39 463 32 105 Property, plant and
equipment, net 9 626 7 831 Other assets 256 208 Total assets 49 345
40 144 LIABILITIES AND SHAREHOLDERS' EQUITY Total current
liabilities 6 316 5 138 Total long-term liabilities 7 325 5 959
Total shareholders' equity 35 705 29 047 Total liabilities and
shareholders' equity 49 345 40 144 Condensed Consolidated
Statements of Operations US GAAP (Amounts in thousands except share
and per share data) Three months ended March 31, 2004 2004 2003 US$
euro euro (Unaudited) Revenues Revenues from collaborative and
licensing agreements 680 553 896 Grants received for research and
development 0 0 0 Total revenues 680 553 896 Operating expenses
Research and development (6 657) (5 416) (5 174) General &
administrative (1 063) (865) (919) Restructuring 0 0 0 Total
operating expenses (7 721) (6 281) (6 093) Loss from operations (7
041) (5 728) (5 197) Interest and other income, net 252 205 357
Income tax benefit 0 0 0 Net loss (6 789) (5 523) (4 840) Loss per
ordinary share (0.68) (0.55) (0.48) Weighted average number of
shares outstanding 10 055 760 10 055 760 10 055 760 Loss per ADS
(American Depositary Share) (0.23) (0.18) (0.16) Weighted average
number of ADSs outstanding 30 167 280 30 167 280 30 167 280 Notes:
The official financial information of Transgene is stated in Euros.
The financial information expressed in US$ is translated solely for
the convenience of the reader at euro 1.00 = $ 1.2292, the noon
buying rate of the Federal Reserve Bank of New York on March 31,
2004. The 2003 accounts have been restated to SFAS 123 "Accounting
for Stock based Compensation." DATASOURCE: Transgene CONTACT:
Philippe Poncet, Chief Financial Officer of Transgene,
+33-3-88-27-91-21; or Michael Long of Cohn & Wolfe, +1-212-798
9775; or Estelle Guillot-Tantay, +33-1-53-70-74-93, or Laurence
Heilbronn, +33-1-53-70-74-64, both of Image 7, all for Transgene
Web site: http://www.transgene.fr/
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