|
| [March 22, 2012] |
 |
EXONHIT SA Reports 2011 Results
PARIS --(Business Wire)--
Regulatory News:
The Management Board of Exonhit SA (Paris:ALEHT) met on March 21 to
close the consolidated financial accounts for the year ending on
December 31, 2011. These accounts were audited by the auditors and
verified by the Supervisory Board.
Commenting on the results, Loïc Maurel, MD, President of the Management
Board of Exonhit SA, said: "2011 was a strategic year, both in terms
of clinical programs and financial performance. The launch of two
clinical studies with AclarusDx®, in France and in the US, are two key
milestones for our Alzheimer's blood test. In parallel, our technology
demonstrated its power and utility through successful developments in
breast cancer diagnostics, and through the renewal for two years of our
R&D partnership with Allergan. These goals were met with a cash
consumption much lower than anticipated. We therefore reiterate our
strategic vision to become a company focused on personalized medicine.
In 2012, Exonhit will expand its portfolio of diagnostic products,
in-house or through collaborations, while maintaining a durable
financial structure".
|
Key figures
|
|
|
|
|
|
|
|
2011 (million EUR)
|
|
|
|
2010 (million EUR)
|
|
Total revenues
|
|
|
|
5.0
|
|
|
|
8.4
|
|
R&D expenses
|
|
|
|
7.7
|
|
|
|
8.5
|
|
Other expenses
|
|
|
|
5.4
|
|
|
|
6.9
|
|
Total operating expenses
|
|
|
|
13.1
|
|
|
|
15.4
|
|
Operating result
|
|
|
|
(8.1)
|
|
|
|
(7.0)
|
|
Net result
|
|
|
|
(7.1)
|
|
|
|
(7.7)
|
|
Cash burn from operations*
|
|
|
|
(6.0)
|
|
|
|
(5.8)
|
|
Consolidated cash and cash equivalent at Dec. 31
|
|
|
|
12.9
|
|
|
|
25.6
|
|
*including R&D tax credit
|
|
|
|
|
|
|
|
|
Stable recurring revenues at approximately € 5 million
Through its collaboration with Allergan, Exonhit receives recurring
payments related to R&D activities performed each year. For products
reaching clinical development, the Company is eligible to receive
milestone payments when specific stages are successfully reached, and
royalties upon commercialization. In 2010, Exonhit received from
Allergan a $ 4 million (€ 2.9 million) payment subsequent to
sublicensing AGN (News - Alert)/EHT 0001 to Bristol-Myers Squibb (BMS). In 2011, BMS
started two phase II clinical trials of the product, which did not
trigger any milestone payment, but may potentially lead to future
revenues in the form of milestones and royalties if the product is
commercialized.
In 2011, consolidated revenues amounted to € 5.0 million compared to €
8.1 million recorded in 2010. They are derived essentially from the
collaboration with Allergan. Excluding the milestone payment received in
2010, recurring revenues related to this collaboration remained stable
at € 5.0 million in 2011, compared to € 5.2 million in 2010.
Significant reduction of operating expenses
Within its new strategy initiated early 2011, the optimization of
research and development activities at Exonhit, including restructuring
of its US affiliate, enabled the Company to improve its efficiency while
reducing its operating expenses. Termination of an acquisition led to
increased G&A expenses in 2010. In 2011, the non-recurrence of these
expenses combined with reductions related to the reorganization and the
timing of AclarusDx® development, led to a reduction of net loss despite
lower revenues. Altogether, all changes in expenses led to savings of
approximately € 2 million per year, and reduction of cash burn. The
financial cost of the final reimbursement of the Company's convertible
debt, which matured in November 2011, did not impact the accounts since
the reimbursement premium was already accrued for in 2010.
Consolidated operating expenses decreased by 15% to € 13.1 million from
€ 15.4 million in 2010. This decrease is principally due to lower R&D
expenses and a substantial decline in G&A expenses.
-
R&D expenses decreased by 9% at € 7.7 million compared to € 8.5
million in 2010. This decrease is mainly related to the restructuring
of R&D activities, including closing the laboratory of the Company's
US affiliate, and to lower clinical expenses for AclarusDx®
compared to 2010. R&D expenses represent 59% of operating expenses in
2011.
-
Marketing and sales expenses increased by 13%, essentially because of
increased marketing efforts for AclarusDx® in 2011.
-
G&A expenses decreased to € 3.9 million compared to € 5.6 million in
2010. This 31% decrease is linked to an overall decrease in
administrative expenses combined with the non-recurrence of expenses
related to an acquisition project that was terminated.
Consequently, Exonhit's operating loss amounts to € 8.1 million compared
to € 7.0 million in 2010, despite a € 3.4 million decrease in revenues.
Interest expenses decreased by 39%, essentially because of the
non-recurrence of expenses corresponding to a loan that was forfeited
after termination of an acquisition project in 2010. 2011 interest
expenses are related to interest paid under the Company's convertible
debt and include the final reimbursement premium that was paid in
November 2011.
Interest income increased from € 0.3 million in 2010 to € 1.5 million in
2011, because of the use of the accrual of € 1.25 million made in 2010
and corresponding to the reimbursement premium of the convertible bonds.
The Company also recorded a currency exchange gain of € 0.2 million,
compared to an exchange loss of € 0.1 million in 2010.
2011 financial income amounts to € 0.4 million, compared to a loss of €
2.1 million in 2010.
In 2011, following the reorganization of the Company's US affiliate, €
0.5 million of extraordinary expenses were recorded. They include
primarily impairments related to the closing of laboratories, and
accruals in connection with lease and indemnities linked to the
restructure and payable in 2012.
The estimated research tax credit amounts to € 1.1 million in 2011,
compared to € 1.3 million for the same period in 2010.
Consequently, Exonhit's 2011 net loss decreased to € 7.1 million
compared to € 7.7 million in 2010, a net loss per share of € 0.21 in
2011 compared to € 0,23 in 2010.
Full reimbursement of long-term debt - approximately 24 months of
cash on the basis of the current burn rate
In 2011, Exonhit reimbursed all outstanding convertible bonds, and
has no remaining long-term debt. This reimbursement was made in cash,
since the Company decided not to refinance the bonds, terms of a new
issue being quite unfavorable due to the overall financial crisis.
However, the reduction of expenses initiated in 2011, combined with a
capital increase completed in the context of the French TEPA law, led to
a cash position of € 12.9 million at December 31, 2011, corresponding to
approximately 24 months of available cash on the basis of the current
cash burn.
Total shareholders' equity amounted to € 13.6 million on December 31,
2011 compared to € 19.2 million on December 31, 2010. This decrease
reflects primarily the consolidated net loss recorded in 2011, partially
offset by a capital increase completed in the context of the French TEPA
law for an amount of € 1.5 million.
As of December 31, 2011, short term debt decreased slightly at € 3.4
million in 2010 compared to € 3.7 million in 2010.
Convertible debt and long-term debt decreased to zero as of December 31,
2011 since all outstanding convertible bonds were reimbursed.
As of December 31, 2011, provisions for risks decreased to € 0.6 million
compared to € 1.5 million on December 31, 2010, mainly because of the
use of the accrual made in 2010 in the context of the potential
reimbursement of the convertible debt.
Hervé Duchesne de Lamotte, Chief Financial Officer of Exonhit, said :
« 2011 enabled us to resize our cost structure and improve our
financial health. Without any milestone payment recorded under the
sub-licensing agreement between Allergan and Bristol-Myers Squibb, as
compared to 2010, we maintained our recurring revenues and, more
importantly, reduced our net loss because of a substantial decrease of
our expenses. As a result, we end 2011 in a stronger financial
situation, without any long-term debt, and approximately 24 months of
cash. We maintain a high level of confidence in our capability to move
forward current programs and to enrich our product portfolio. »
Review of the evolution of the product portfolio in 2011
• Allergan Collaboration: renewed for two additional years Exonhit
extended its collaboration with Allergan through the end of 2013, which
is focused on the identification, development and commercialization of
drugs for the treatment of neurodegenerative diseases, pain and
ophthalmology. This is the fifth renewal of the collaboration. EHT/AGN
0001, the most advanced product discovered within the Allergan
collaboration, was sub-licensed by Allergan to Bristol-Myers Squibb
(BMS) in March 2010. EHT/AGN 0001 is a Phase II, orally bio-available
small molecule in clinical development for neuropathic pain (1).
Alzheimer's disease
• AclarusDx ®: CE marking and initiation of two clinical studies in
France and in the US AclarusDx® is a test to aid in the
diagnosis of Alzheimer Disease (AD) by detecting disease specific
biomarkers in blood. CE marking of this test was obtained in March 2011. As
part of the introduction of AclarusDx® in France, the company
initiated in December 2011 a real life clinical study, the aim of which
is both to familiarize memory centers with the test and to define the
position of AclarusDx® among tools and exams currently available to
establish the diagnosis of the disease. According to its plans, the
company expects to complete recruitment of the target 600 patients
during the summer of 2012. In the US, Exonhit also initiated in
November 2011 a pilot clinical study, the objective of which is to
evaluate the positioning of AclarusDx® within the current
diagnostic algorithm and to test its performance in a population of 160
American patients who are expected to be recruited by the end of May
2012.
• Collaboration with Pfizer: prognostic biomarkers in Alzheimer's
disease In October 2011, Exonhit initiated, in collaboration
with Pfizer, a pilot clinical study to identify, with its Genome Wide
Splice Array (GWSA) platform, prognostic biomarkers that could segregate
healthy elderly controls, from patients with mild cognitive impairment
(MCI) and patients with AD. This study is currently ongoing.
Breast cancer
• EHT Dx14: validation of the excellent performance of the test EHT
Dx14 is a biomarker for the diagnosis of breast cancer. Faced with a
suspicious cyst discovered during mammography the test allows the
accurate reading of samples obtained by Fine Needle Aspiration (FNA),
especially in cases where the standard analysis returns an indeterminate
result. The performance of EHT Dx14 was validated during the summer of
2011. Taking into account the expected frequency of uncertain diagnosis
in the general population, the adjusted global performance of EHT Dx14
is 93.4% (post hoc analysis); its specificity is 90.7% and its
sensitivity, 96.1%. This performance above 90% in the population of
patients for whom FNA was performed at Institut Gustave Roussy, confirms
the ability of Exonhit's technology to identify biomarkers and generate
diagnostic tests with excellent performance. Exonhit is currently
evaluating the market for this product.
• Consortium Responsify: companion diagnostics in breast cancer Bolstered
by the results of EHT Dx14 with Institut Gustave Roussy, Exonhit was
selected with prestigious academic partners and other European companies
to participate in a European consortium of personalized medicine with
the aim to identify biomarkers of response to Herceptin® and
Avastin®, two chemotherapeutic agents marketed by Roche and
commonly used to treat women with breast cancer. This project received a
total grant of € 6 million of which € 0.4 million will be distributed to
the Company, which covers over 70% of the costs to develop its first
companion diagnostic. The objective for Exonhit is to introduce and
market predictive tests that have been identified on its GWSA platform
in this major market of breast cancer treatment.
Prostate cancer
• Collaboration with bioMérieux blood biomarkers The
collaboration with bioMérieux, for the development of blood-based
biomarkers for prostate cancer, is ongoing.
2012 outlook: development of product portfolio and partnerships
After concentrating on execution of Exonhit's main programs in 2011,
2012 will be geared toward a deployment of its technology to increase
the size of its diagnostic product portfolio and the number of
partnerships, while maintaining expenses under strict control.
In therapeutics, the Company will aim at valuing existing molecules that
were developed in-house, and use its GWSA technology to enter into new
partnerships.
The diagnostic portfolio will be enriched, through in-house programs and
collaborations, with a goal to turn Exonhit into a key player in
personalized medicine.
A meeting for institutional investors, analysts and journalists will
be held by Exonhit's management team today, Tuesday, March 22, 2012 at
8:30 CET.
2012 Financial Calendar
Shareholders Annual General Meeting: April 12, 2012
Half-year results: September 11, 2012
About Exonhit
Exonhit (Alternext: ALEHT) is a biotech company, focused on personalized
medicine, which develops targeted innovative therapeutic and diagnostic
products, in oncology and Alzheimer's disease. Exonhit has a balanced
development strategy with internal development programs and strategic
collaborations.
Exonhit is headquartered in Paris, France and has a U.S. subsidiary in
Gaithersburg, Maryland. The Company is listed on NYSE Alternext in Paris
and is part of the NYSE Alternext OSEO innovation index. For more
information, please visit http://www.exonhit.com.
Disclaimer
This press release contains elements that are not historical facts
including, without limitation, certain statements about future
expectations and other forward-looking statements. Such statements are
based on management's current views and assumptions and involve known
and unknown risks and uncertainties that could cause actual results,
performance or events to differ materially from those anticipated.
In addition, Exonhit, its shareholders, and its affiliates,
directors, officers, advisors and employees have not verified the
accuracy of, and make no representations or warranties in relation to,
statistical data or predictions contained in this press release that
were taken or derived from third party sources or industry publications,
and such statistical data and predictions are used in this press release
for information purposes only.
Finally, this press release may be drafted in the French and English
languages. In an event of differences between the texts, the French
language version shall prevail.
|
EXONHIT S.A.
|
|
|
|
CONSOLIDATED INCOME STATEMENT
|
|
(in thousands of euros, except per share data)
|
|
|
|
|
|
|
|
12 months December 31, 2011
|
|
|
|
12 months December 31, 2010
|
|
|
|
|
|
|
|
Research and Development revenues
|
|
|
|
4,978
|
|
|
|
8,077
|
|
Other products
|
|
|
|
11
|
|
|
|
94
|
|
Research & Development grants
|
|
|
|
4
|
|
|
|
247
|
|
|
|
|
|
|
|
|
|
|
|
Total revenues
|
|
|
|
4,993
|
|
|
|
8,418
|
|
|
|
|
|
|
|
|
|
|
|
Research and Development expenses
|
|
|
|
(7,717)
|
|
|
|
(8,480)
|
|
Marketing and Sales expenses
|
|
|
|
(1,508)
|
|
|
|
(1,334)
|
|
General and Administrative expenses
|
|
|
|
(3,863)
|
|
|
|
(5,578)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Total operating expenses
|
|
|
|
(13,088)
|
|
|
|
(15,392)
|
|
|
|
|
|
|
|
|
|
|
|
Loss from operations
|
|
|
|
(8,095)
|
|
|
|
(6,974)
|
|
|
|
|
|
|
|
|
|
|
|
Interest expense
|
|
|
|
(1,365)
|
|
|
|
(2,230)
|
|
Interest income
|
|
|
|
1,522
|
|
|
|
271
|
|
Currency exchange gain (loss) - net
|
|
|
|
227
|
|
|
|
(144)
|
|
Financial income (loss)
|
|
|
|
384
|
|
|
|
(2,103)
|
|
|
|
|
|
|
|
|
|
|
|
Extraordinary expense
|
|
|
|
(491)
|
|
|
|
-
|
|
Extraordinary income
|
|
|
|
-
|
|
|
|
-
|
|
Income (loss) before tax
|
|
|
|
(8,202)
|
|
|
|
(9,077)
|
|
|
|
|
|
|
|
|
|
|
|
Tax benefit
|
|
|
|
1,103
|
|
|
|
1,329
|
|
Net income (loss)
|
|
|
|
(7,099)
|
|
|
|
(7,748)
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding
|
|
|
|
33,670,511
|
|
|
|
33,082,489
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share
|
|
|
|
(0.21)
|
|
|
|
(0.23)
|
|
Net loss per share (diluted)
|
|
|
|
(0.21)
|
|
|
|
(0.23)
|
|
|
|
|
|
EXONHIT S.A.
|
|
|
|
CONSOLIDATED BALANCE SHEET
|
|
(in thousands of euros)
|
|
|
|
|
|
|
|
|
|
|
|
ASSETS
|
|
|
|
December 31, 2011
|
|
|
|
December 31, 2010
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Intangible assets, net
|
|
|
|
6
|
|
|
|
142
|
|
Property and equipment, net
|
|
|
|
655
|
|
|
|
1,282
|
|
Other long term assets
|
|
|
|
379
|
|
|
|
347
|
|
Total long-term assets
|
|
|
|
1,040
|
|
|
|
1,772
|
|
|
|
|
|
|
|
|
|
|
|
Accounts and grants receivable
|
|
|
|
1,031
|
|
|
|
1,173
|
|
Other short term assets
|
|
|
|
2,607
|
|
|
|
2,710
|
|
Cash and cash equivalents
|
|
|
|
12,925
|
|
|
|
25,607
|
|
Total short-term assets
|
|
|
|
16,563
|
|
|
|
29,490
|
|
TOTAL ASSETS
|
|
|
|
17,603
|
|
|
|
31,261
|
|
|
|
|
|
|
|
|
|
|
|
LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
|
|
|
|
|
|
|
|
Share capital
|
|
|
|
546
|
|
|
|
533
|
|
Additional paid-in capital
|
|
|
|
96,783
|
|
|
|
95,432
|
|
Accumulated deficit
|
|
|
|
(84,899)
|
|
|
|
(77,801)
|
|
Other
|
|
|
|
1,138
|
|
|
|
1,027
|
|
Shareholders' equity
|
|
|
|
13,567
|
|
|
|
19,191
|
|
|
|
|
|
|
|
|
|
|
|
Convertible bonds
|
|
|
|
-
|
|
|
|
6,522
|
|
|
|
|
|
|
|
|
|
|
|
Provisions for risks
|
|
|
|
632
|
|
|
|
1,534
|
|
|
|
|
|
|
|
|
|
|
|
Long-term debt less current portion
|
|
|
|
-
|
|
|
|
15
|
|
Long-term portion of deferred income
|
|
|
|
-
|
|
|
|
-
|
|
Total long-term liabilities
|
|
|
|
-
|
|
|
|
15
|
|
|
|
|
|
|
|
|
|
|
|
Current portion of long-term debt
|
|
|
|
-
|
|
|
|
107
|
|
Current portion of capital lease obligations
|
|
|
|
15
|
|
|
|
66
|
|
Accounts payable
|
|
|
|
905
|
|
|
|
904
|
|
Accrued liabilities
|
|
|
|
1,463
|
|
|
|
1,736
|
|
Deferred income short-term
|
|
|
|
1,022
|
|
|
|
1,185
|
|
Total short-term liabilities
|
|
|
|
3,404
|
|
|
|
3,999
|
|
TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY
|
|
|
|
17,603
|
|
|
|
31,261
|
|
|
|
|
|
EXONHIT S.A.
|
|
|
|
CONSOLIDATED CASH FLOW STATEMENT
|
|
|
|
(in thousands of euros)
|
|
|
|
Year ending Dec 31, 2011
|
|
|
|
Year ending Dec 31, 2010
|
|
|
|
|
|
|
|
|
|
|
|
OPERATIONS
|
|
|
|
|
|
|
|
|
|
Net loss
|
|
|
|
(7,099)
|
|
|
|
(7,748)
|
|
Less:
|
|
|
|
|
|
|
|
|
|
Depreciation and amortization of property & equipment
|
|
|
|
638
|
|
|
|
577
|
|
Depreciation of intangible assets
|
|
|
|
128
|
|
|
|
130
|
|
Net book value of impaired assets
|
|
|
|
29
|
|
|
|
-
|
|
Allowance for bad debts
|
|
|
|
-
|
|
|
|
93
|
|
OSEO loan forgiveness
|
|
|
|
-
|
|
|
|
-
|
|
Retirement liability accrual and other
|
|
|
|
352
|
|
|
|
(64)
|
|
Other accruals/ Convertible bonds reimbursement premium
|
|
|
|
-
|
|
|
|
1,254
|
|
Reversal of accruals/ Convertible bonds reimbursement premium
|
|
|
|
(1,254)
|
|
|
|
-
|
|
Capitalized interests on convertible bonds
|
|
|
|
1,339
|
|
|
|
-
|
|
Other
|
|
|
|
41
|
|
|
|
30
|
|
|
|
|
|
|
|
|
|
|
|
Increase (decrease) in cash from:
|
|
|
|
|
|
|
|
|
|
Inventory
|
|
|
|
(9)
|
|
|
|
(16)
|
|
Accounts receivable
|
|
|
|
142
|
|
|
|
(154)
|
|
Research tax credit receivable
|
|
|
|
226
|
|
|
|
287
|
|
Prepaid expenses and other assets
|
|
|
|
(122)
|
|
|
|
(81)
|
|
Accounts payable and accrued expenses
|
|
|
|
4
|
|
|
|
(410)
|
|
Accrued compensation
|
|
|
|
(273)
|
|
|
|
343
|
|
Deferred income, short term
|
|
|
|
(164)
|
|
|
|
75
|
|
Deferred income, long term
|
|
|
|
-
|
|
|
|
(119)
|
|
|
|
|
|
|
|
|
|
|
|
Net cash used in operations
|
|
|
|
(6,023)
|
|
|
|
(5,803)
|
|
|
|
|
|
|
|
|
|
|
|
INVESTING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
Purchase of property and equipment
|
|
|
|
(149)
|
|
|
|
(220)
|
|
Payment of patent and acquisition of other intangibles
|
|
|
|
77
|
|
|
|
84
|
|
Net cash used in investing activities
|
|
|
|
(72)
|
|
|
|
(135)
|
|
|
|
|
|
|
|
|
|
|
|
FINANCING ACTIVITIES
|
|
|
|
|
|
|
|
|
|
Issuance of shares (net of fees)
|
|
|
|
1,364
|
|
|
|
1,238
|
|
Reimbursement of convertible bonds
|
|
|
|
(7,968)
|
|
|
|
|
|
Reimbursement of loans and lease obligations
|
|
|
|
(66)
|
|
|
|
(129)
|
|
Net cash provided by (used in) financing activities
|
|
|
|
6670
|
|
|
|
1,109
|
|
|
|
|
|
|
|
|
|
|
|
Net increase (decrease) in cash and cash equivalents
|
|
|
|
(12,765)
|
|
|
|
(4,829)
|
|
Effects of currency exchange rate on cash
|
|
|
|
84
|
|
|
|
191
|
|
Cash and cash equivalents, beginning of period
|
|
|
|
25,607
|
|
|
|
30,245
|
|
Cash and cash equivalents, end of period
|
|
|
|
12,925
|
|
|
|
25,607
|

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