|
| [March 19, 2012] |
 |
Transgene Reports Full Year 2011 Results
STRASBOURG, France --(Business Wire)--
Regulatory News:
-
Important clinical data published in 2011 and significant upcoming
news-flow
-
Cash burn in line with guidance and €139.5 million in cash at end
2011
Transgene (Paris:TNG)(Euronext Paris: FR0005175080) announces
today its annual financial results for 2011 and updates the market on
its strategy and its portfolio of product candidates. The consolidated
2011 financial statements were approved by the Board of Directors on
March 15, 2012, and will be submitted for approval by the shareholders
of the Company during its next annual general meeting, on June 21, 2012.
The audit procedures have been performed and the auditors' report will
be issued upon review of the annual report.
Financial Statements for 2011 (enclosed):
Key highlights of the 2011 annual financial statements are as follows:
-
Revenue amounted to 14.4 million euros in 2011, compared with 14.1
million euros in 2010 (+2%),
-
An increase by approximately 25% in research and development expenses
to 53.0 million euros in 2011 (from 42.5 million euros in 2010), due
principally to the increase in clinical trials expenses as well as to
milestone payments under licensing agreements,
-
A net loss of 43.6 million euros in 2011, compared to 34.2 million
euros in 2010, due principally to the increase in research and
development expenses, and
-
A net cash consumption of 40.8 million euros, in line with guidance.
As of December 31, 2011, the Company had 139.5 million euros in cash,
cash equivalents and other financial assets. Transgene expects a cash
consumption of around 50 million euros in 2012. The increase from 2011
would principally be due to the growth in expenses in relation to
clinical trials for the product candidates TG4010 and JX594/TG6006.
Update on the Strategy and the Portfolio of
Product Candidates:
At the end of 2011, Transgene has started TIME, a phase 2b/3 clinical
trial in non-small cell lung cancer ("NSCLC") with TG4010, a therapeutic
vaccine. First clinical centers are open (in six countries) for
recruitment and first patients have been screened.
Together with its partner Jennerex, Inc., Transgene has recently started
TRAVERSE, a phase 2b clinical trial for the second line treatment of
advanced Hepatocarcinoma (liver cancer). A new study in HCC is due to
start in the middle of this year which , together with 4 other phase 2
trials in liver cancer and/or metastatic colorectal cancer, should
enable the partners to best define the strategy for the upcoming phase 3
expected to start in 2013.
For TG4040, a therapeutic vaccine in type C hepatitis ("HCV"), Transgene
has recently (November 2011) announced promising clinical data. The
Company will publish an update of these data during the upcoming EASL
meeting in April (selected for oral presentation). Transgene is
currently in discussion with several potential partners for the next
stage of development of this product which the Company intends to
position as the immunotherapeutic option of choice for use in
combination with novel antiviral agents.
Transgene expects from Roche (for the second quarter of 2012) the
interim efficacy data of the 200-patients large phase 2b trial conducted
by the latter with TG4001, a therapeutic vaccine developed in HPV-caused
precancerous lesions of the cervix. Positive data would open new
perspectives for this product, the rights of which were entirely granted
back to Transgene last year. Based on the data, Transgene intends to
find one or more partners for the pivotal development and the future
commercialization of this product.
Lastly, operations in the 50:50 Chinese joint venture company between
Transgene and Tasly as well as in Transgene's wholly-owned Chinese
company dedicated to translational research are expected to start in
2012.
"2011 was a rich year for Transgene in terms of news-flow, with
important clinical data for our therapeutic vaccine in HCV as well as
high level publications for our TG4010 and JX594/TG6006 products" said
Philippe Archinard, Chairman and CEO of Transgene. He added: "We have
recently started important studies for our lead products and we expect
several key clinical data in the upcoming 18 months. We have the
financial means to pursue our ambitious strategy and are confident for
our long term prospect".
The company will host a conference call and webcast in English today,
Monday, March 19th. The conference call and webcast will start at 7pm
CET. The dial-in numbers are:
+44(0)20 7136 2050 (UK)
+1646 254 3366 (US)
+41(0)43 547 8000
(Switzerland)
+33(0)1 70 99 42 71 (France)
Confirmation code: 4512046
The weblink for the webcast is: http://www.media-server.com/m/p/q42ovq4i
DISCUSSION ON (News - Alert) FINANCIALS FOR 2011
Income statement:
|
In thousands of euros
|
|
12/31/2011
|
|
12/31/2010
|
|
Revenue from collaborative and licensing agreements
|
|
5,646
|
|
5,648
|
|
Government financing for research expenditures
|
|
8,800
|
|
8,464
|
|
Revenue
|
|
14,446
|
|
14,112
|
|
Research and development expenses
|
|
(53,048)
|
|
(42,521)
|
|
General and administrative expenses
|
|
(6,226)
|
|
(6,296)
|
|
Other income and (expenses), net
|
|
-
|
|
100
|
|
Net operating expenses
|
|
(59,274)
|
|
(48,717)
|
|
Operating income
|
|
(44,828)
|
|
(34,605)
|
|
Interest income and (expenses), net
|
|
1 426
|
|
386
|
|
Income / (loss) before tax
|
|
(43,402)
|
|
(34,219)
|
|
Income tax expense
|
|
-
|
|
-
|
|
Share of profit (loss) of associates and joint ventures
|
|
(224)
|
|
-
|
|
Net income / (loss)
|
|
(43,626)
|
|
(34,219)
|
|
Net income per share (€)
|
|
(1.38)
|
|
(1.24)
|
|
Diluted earnings per share (€)
|
|
(1.38)
|
|
(1.24)
|
Revenue:
During 2011, revenue from collaborative and licensing agreements were
composed principally of:
-
Revenue from collaborative research and manufacturing activities for
partners third parties (such as for Roche, in connection with TG4001,
or Jennerex, Inc. in connection with JX594/TG6006), amounting to 2.8
million euros (1.7 million euros in 2010),
-
Milestone or upfront payments on products partnered-out (such as the
option payment from Novartis in connection with TG4010), amounting to
2.1 million euros (3.2 million euros in 2010), and
-
Royalties on sales of technologies or products out-licensed by
Transgene, amounting to 0.7 million euros (unchanged).
The 10.0 million US dollars (7.4 million euros) received from Novartis
in March 2010 for the payment of the exclusive option for an exclusive
license to TG4010, was spread over the expected duration period of the
option. This period runs from the date of signature up to June 30, 2013.
Revenue recognized on this option amounted to 2.1 million euros (2.7
million euros in 2010). The balance (2.6 million euros) will be
recognized in revenue in 2012 and 2013.
For the year ending December 31, 2011, government financing for research
expenditures are composed of subsidies received or accrued and research
tax credit for the year 2011.
Subsidies amounted to 1.0 million euros in 2011, compared with 0.9
million euros in 2010. In 2011, subsidies were related principally to
the ADNA program (a program to develop biomarkers for new therapeutics),
funded by the French innovation agency OSEO. Transgene expects to cash
in another 1.9 million euros in subsidies in relation to this program in
the future (3.2 million euros in revenue, as part of this amount was
already cashed-in).
The research tax credit amounted to 7.8 million euros in 2011,
unchanged. Net eligible expenses amounted to 25.9 million euros in 2011
(26.2 million euros in 2010). The variation in net eligible expenses
between 2010 and 2011 does not reflect the change in research and
development expenses (+25%). This is explained by (i) a change in
research tax credit calculation methodology introduced for the fiscal
year 2011 (decrease in the percentage of overheads charged on staff
costs) that has had a negative impact of 1.7 million euros on the
eligible expenses as well as by (ii) 4.1 million euros in subsidies and
grants cashed-in during the year and deducted from the eligible expenses
(1.7 million euros in 2010). In addition, research and development
expenses included 6.9 million euros in milestone payments (nil in 2010).
These expenses are not eligible expenses for the research tax credit
calculation.
Operating expenses:
R&D expenses amounted to 53.0 million euros in 2011, compared with 42.5
million euros in 2010, an increase of 25%. This increase was due
principally to the increase in expenses relating to clinical trials as
well as milestone payments to Jennerex, Inc. in relation to the
JX594/TG6006 license agreement.
The table below lists the research and development expenses per nature
of expense:
|
In million euros
|
|
12/31/2011
|
|
12/31/2010
|
|
Staff costs
|
|
18.9
|
|
17.5
|
|
Payment in shares
|
|
1.1
|
|
0.7
|
|
External intellectual property and licensing costs
|
|
9.2
|
|
2.2
|
|
External expenses on clinical trials
|
|
8.6
|
|
6.6
|
|
External expenses on other projects
|
|
3.9
|
|
4.2
|
|
Internal/structure costs
|
|
8.6
|
|
9.0
|
|
Depreciation and amortization
|
|
2.7
|
|
2.3
|
|
Research and development expenses
|
|
53.0
|
|
42.5
|
R&D staff costs amounted to 18.9 million euros in 2011, to be compared
with 17.5 million euros in 2010. This variation is explained by an
increase in headcount (242 FTE in 2011 vs. 230 in 2010) as well as by an
increase in salaries (3% in average).
External intellectual property and licensing costs amounted to 9.2
million euros in 2011, to be compared with 2.2 million euros in 2010.
This increase is mostly explained by payments made or due to Jennerex,
Inc. for clinical and production milestone achieved in 2011 with
JX594/TG6006 (6.9 million euros in 2011, nil in 2010).
External expenses on clinical trials amounted to 8.6 million euros in
2011, to be compared with 6.6 million euros in 2010. This increase is
explained by the clinical advancement in 2011 of our most advanced
products: TG4040 (4.2 million euros in 2011 vs. 3.0 million euros in
2010), TG4010 (3.1 million euros in 2011, unchanged) and JX594/TG6006
(0.9 million euros in 2011 vs. insignificant in 2010).
External expenses on other projects, including research, pre-clinical
and industrial projects, amounted to 3.9 million euros in 2011, to be
compared with 4.2 million euros in 2010. This decrease is mostly
explained by a decrease in outsourcing activities on industrial projects
(0.6 million euros in 2011 vs. 1.4 million euros in 2010), notably for
the development of novel manufacturing processes.
Internal/structure costs are expenses related to operating the research
and production facilities, including but not limited to cost of the
finance lease, maintenance costs and supply of laboratory materials.
These costs amounted to 8.6 million euros in 2011, compared to 9.0
million euros in 2010. This decrease is mostly driven by a decrease in
laboratory supply (4.0 million euros in 2011 vs. 4.4 million euros in
2010) as Transgene focused on its most advanced clinical projects.
The table below lists the general and administrative expenses per nature
of expense:
|
In million euros
|
|
12/31/2011
|
|
12/31/2010
|
|
Staff costs
|
|
2.7
|
|
2.9
|
|
Payment in shares
|
|
0.4
|
|
0.4
|
|
Advisory and management fees
|
|
2.1
|
|
1.9
|
|
Other overheads
|
|
0.9
|
|
1.0
|
|
Depreciation and amortization
|
|
0.1
|
|
0.1
|
|
General and administrative expenses
|
|
6.2
|
|
6.3
|
G&A staff costs amounted to 2.7 million euros in 2011, to be compared
with 2.9 million euros in 2010. This variation is mostly explained by a
non-recurring expense in 2010.
Advisory and management fees amounted to 2.1 million euros in 2011, to
be compared with 1.9 million euros in 2010.
Interest income and (expenses), net:
Interest income, net of interest expenses, amounted to 1.4 million euros
in 2010 (0.4 million euros in 2010). Interest income on investments
amounted to 1.9 million euros in 2011 (1.0 million euros in 2010). The
interest expenses were principally related to the interest on lease
financing of the main premises of Transgene (0.4 million euros in 2011).
Net loss:
Net loss amounted to 43.6 million euros in 2011, compared with 34.2
million euros in 2010. Net loss per share amounted to 1.38 euros in 2011
(1.24 euros per share in 2010).
Investments:
In 2011 and 2010, investment in tangible and intangible assets amounted
respectively to 3.8 and 3.7 million euros. In 2011, Transgene also
invested 1.75 million US dollars in the equity capital of its strategic
partner Jennerex, Inc. (5.0 million US dollars, or 3.8 million euros, in
2010).
Borrowings and conditional subsidies:
In 2011, Transgene received 3.1 million euros in conditional subsidies
from OSEO in relation to the ADNA program (see above). The Company
expects to receive another 9.4 million euros in conditional loans up to
the end of this program (2016).
Cash, cash equivalents and other financial
assets:
Cash is invested primarily in short term mutual funds or in a cash
pooling managed by the Institut Mérieux, its controlling shareholder. As
of December 31, 2011, the Company had 139.5 million euros in cash, cash
equivalents and other financial assets, compared with 180.3 million
euros as of December 31, 2010.
Elements of cash flow:
Excluding the investment made in the equity capital of Jennerex, Inc.
(1.75 million US dollars), the cash consumption amounted to 39.6 million
euros in 2011 (28.8 million euros in 2010).
Including the 1.75 million US dollars investment made in the equity
capital of Jennerex, Inc., the cash consumption of Transgene amounted to
40.8 million euros in 2011.
About Transgene:
Transgene, a member of the Institut Mérieux Group, is a publicly traded
French biopharmaceutical company dedicated to the development of
therapeutic vaccines and immunotherapeutic products in oncology and
infectious diseases and has four compounds in Phase II clinical
development: TG4010 and JX594/TG6006 having already completed initial
Phase II trials, TG4001 and TG4040. Transgene has concluded strategic
agreements for the development of two of its immunotherapy products: an
option agreement with Novartis for the development of TG4010 to treat
various cancers and an in-licensing agreement with US-based Jennerex,
Inc. to develop and market JX594/TG6006, an oncolytic virus. Transgene
has bio-manufacturing capacities for viral-based products. Additional
information about Transgene is available at www.transgene.fr.
Disclaimer:
This press release contains forward-looking statements notably
referring to the anticipated cash consumption for 2012. The Company's
anticipated cash consumption for 2012 is based on currently anticipated
costs for on-going and planned product development and testing, but may
increase in the event of unanticipated expenses. For further information
on the risks and uncertainties involved in the testing and development
of Transgene's product candidates, see Trangene's Document de Référence
on file with the French Autorité des marchés financiers on its website
at http://www.amf-france.org
and on Transgene's website at www.transgene.fr
.
CONSOLIDATED FINANCIAL STATEMENTS
Consolidated balance sheet, IFRS
(in thousands of euros)
|
ASSETS
|
|
12/31/2011
|
|
12/31/2010
|
|
Current assets:
|
|
|
|
|
|
Cash and cash equivalents
|
|
1,733
|
|
1,379
|
|
Other current financial assets
|
|
137,774
|
|
178,917
|
|
Cash, cash equivalent and other financial assets:
|
|
139,507
|
|
180,296
|
|
Receivables
|
|
624
|
|
1,162
|
|
Inventories
|
|
1,093
|
|
972
|
|
Other current assets
|
|
2,560
|
|
2,764
|
|
Total current assets
|
|
143,784
|
|
185,195
|
|
Non-current assets:
|
|
|
|
|
|
Property, plant and equipment
|
|
25,507
|
|
24,763
|
|
Intangible assets
|
|
1,581
|
|
1,650
|
|
Financial assets
|
|
6,175
|
|
4,111
|
|
Associates and joint ventures
|
|
544
|
|
113
|
|
Other non-current assets
|
|
15,993
|
|
7,855
|
|
Total non-current assets
|
|
49,800
|
|
38,492
|
|
Total assets
|
|
193,584
|
|
223,686
|
|
|
|
|
|
|
|
EQUITY and LIABILITIES
|
|
12/31/2011
|
|
12/31/2010
|
|
Current liabilities:
|
|
|
|
|
|
Payables
|
|
10,840
|
|
8,714
|
|
Financial liabilities
|
|
955
|
|
930
|
|
Provision for risks
|
|
3
|
|
2
|
|
Other current liabilities
|
|
9,319
|
|
8,773
|
|
Total current liabilities
|
|
21,117
|
|
18,419
|
|
Non-current liabilities:
|
|
|
|
|
|
Financial liabilities
|
|
27,374
|
|
16,904
|
|
Defined benefit obligations
|
|
2,794
|
|
2,390
|
|
Other non-current current liabilities
|
|
883
|
|
2,355
|
|
Total non-current liabilities
|
|
31,051
|
|
21,649
|
|
Total liabilities
|
|
52,168
|
|
40,068
|
|
Equity:
|
|
|
|
|
|
Share capital
|
|
72,523
|
|
72,460
|
|
Share premiums
|
|
426,041
|
|
424,408
|
|
Retained earnings
|
|
(313,030)
|
|
(278,810)
|
|
Net loss for the year
|
|
(43,626)
|
|
(34,219)
|
|
Other comprehensive income
|
|
(492)
|
|
(221)
|
|
Total Equity and Reserves Attributable to Equity Holders of the
Company
|
|
141,416
|
|
183,618
|
|
Total equity and liabilities
|
|
193,584
|
|
223,686
|
Income statement
(in thousands of euros, except for per
share data)
|
|
|
12/31/2011
|
|
12/31/2010
|
|
Revenue from collaborative and licensing agreements
|
|
5,646
|
|
5,648
|
|
Government financing for research expenditures
|
|
8,800
|
|
8,464
|
|
Revenue
|
|
14,446
|
|
14,112
|
|
Research and development expenses
|
|
(53,048)
|
|
(42,521)
|
|
General and administrative expenses
|
|
(6,226)
|
|
(6,296)
|
|
Other income and (expenses), net
|
|
-
|
|
100
|
|
Net operating expenses
|
|
(59,274)
|
|
(48,717)
|
|
Operating income
|
|
(44,828)
|
|
(34,605)
|
|
Interest income and (expenses), net
|
|
1 426
|
|
386
|
|
Income / (loss) before tax
|
|
(43,402)
|
|
(34,219)
|
|
Income tax expense
|
|
-
|
|
-
|
|
Share of profit (loss) of associates and joint ventures
|
|
(224)
|
|
-
|
|
Net income / (loss)
|
|
(43,626)
|
|
(34,219)
|
|
Net income per share (€)
|
|
(1.38)
|
|
(1.24)
|
|
Diluted earnings per share (€)
|
|
(1.38)
|
|
(1.24)
|
Comprehensive income
(in thousands of euros)
|
|
|
12/31/2011
|
|
12/31/2010
|
|
Net loss
|
|
(43,626)
|
|
(34,219)
|
|
Foreign exchange gains or losses
|
|
(1)
|
|
2
|
|
Reevaluation of hedging instruments
|
|
(270)
|
|
(134)
|
|
Other comprehensive income
|
|
(271)
|
|
(132)
|
|
Comprehensive income
|
|
(43,897)
|
|
(34,351)
|
|
Of which, equity holders of the parent:
|
|
(43,897)
|
|
(34,351)
|
|
Of which, minority interests:
|
|
-
|
|
-
|
Consolidated cash flow statement, IFRS
(in thousands of
euros)
|
|
|
12/31/2011
|
|
12/31/2010
|
|
Cash flow from operating activities:
|
|
|
|
|
|
Operating income
|
|
(44,828)
|
|
(34,604)
|
|
Elimination of non-cash elements:
|
|
|
|
|
|
Changes in provisions
|
|
260
|
|
183
|
|
Depreciation and amortization of tangible and intangible assets
|
|
2,740
|
|
2,413
|
|
Payments in shares
|
|
1,441
|
|
1,038
|
|
Others
|
|
5
|
|
72
|
|
Net cash generated from / (used in) operating activities before
change in working capital and other operating cash flow:
|
|
(40,383)
|
|
(30,898)
|
|
Changes in operating working capital:
|
|
|
|
|
|
Receivables
|
|
685
|
|
(87)
|
|
Research tax credit accrued for the period
|
|
(7,785)
|
|
(7,855)
|
|
Research tax credit refunded by the Government during the period
|
|
-
|
|
4,824
|
|
Inventories
|
|
(121)
|
|
(155)
|
|
Other current assets
|
|
219
|
|
(800)
|
|
Payables
|
|
2,292
|
|
3,616
|
|
Prepaid income
|
|
(1,678)
|
|
5,181
|
|
Accrued employee benefits expense
|
|
39
|
|
631
|
|
Other current liabilities
|
|
714
|
|
2
|
|
Net cash generated from / (used in) operating activities before
other operating cash flow:
|
|
(46,018)
|
|
(25,541)
|
|
Other operating cash flows:
|
|
|
|
|
|
Financial income
|
|
1,941
|
|
970
|
|
Financial expenses
|
|
(401)
|
|
(392)
|
|
Exchange gains and losses
|
|
316
|
|
34
|
|
Net cash generated from / (used in) operating activities:
|
|
(44,162)
|
|
(24,929)
|
|
Cash flow from investing activities:
|
|
|
|
|
|
(Purchase) / disposal of property, plant and equipment
|
|
(3,302)
|
|
(3,206)
|
|
(Purchase) / disposal of intangible assets
|
|
(548)
|
|
(526)
|
|
Other (purchase) / disposal
|
|
(1,668)
|
|
(3,949)
|
|
Net cash generated from / (used in) investing activities:
|
|
(5,518)
|
|
(7,681)
|
|
Cash flow from financing activities:
|
|
|
|
|
|
Gross proceeds from issuance of share capital
|
|
254
|
|
152,435
|
|
Fees paid in relation to capital increase
|
|
-
|
|
(4,067)
|
|
Conditional subsidies
|
|
3,103
|
|
740
|
|
(Acquisition)/disposal of current financial assets
|
|
41,143
|
|
(178,917)
|
|
Financing of the research tax credit for previous periods
|
|
6,465
|
|
-
|
|
Repayment of finance lease liabilities
|
|
(930)
|
|
(897)
|
|
Net cash generated from / (used in) financing activities:
|
|
50,035
|
|
(30,706)
|
|
Effect of changes in exchange rates on cash and cash equivalents
|
|
(1)
|
|
2
|
|
Net increase (decrease) in cash and cash equivalents:
|
|
354
|
|
(63,314)
|
|
Cash and cash equivalents at beginning of period
|
|
1,379
|
|
64,693
|
|
Cash and cash equivalents at end of period
|
|
1,733
|
|
1,379
|
|
Investment in other financial assets
|
|
137,774
|
|
178,917
|
|
Cash, cash equivalent and other financial assets:
|
|
139,507
|
|
180,296
|
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