“We are starting 2010
with a strong cash position that will allow us to make the acquisition
of a US molecular diagnostic company and to prepare for the launch of
AclarusDx in the IVD market.”
2009 Key product milestones
Therapeutics
-
Positive Phase 2a results for EHT 0202, ExonHit’s lead candidate in
Alzheimer’s disease
-
Successful completion of Phase 1 safety studies for EHT/AGN 0001
Diagnostics
-
Successful completion of clinical validation for AclarusDx™
Alzheimer’s test
-
First product launch with AclarusDx™ Alzheimer’s test as a “research
use only” product
-
In-licensing from Institut Gustave Roussy of EHT Dx14, a novel breast
cancer diagnostic
2009 Key events
-
Strengthening of cash position through equity funding, with € 30
million at year end
-
Appointment of a new CFO with a strong biotech experience
2010 Outlook
Therapeutics
-
Out-licensing of EHT/AGN 0001 program
-
Agreement with a partner in 2H 2010 for further development of EHT 0202
-
Signing of new R&D collaborations
Diagnostics
-
Acquisition of a revenue-generating US molecular diagnostic company by
Q3 2010
-
CE marking of AclarusDx™ Alzheimer’s test in Q4 2010, and launch in
Europe in Q1 2011
-
Launch EHT Dx14 in Q3 2010 as a “research use only” product
-
First commercial revenues out of the Diagnostics portfolio
Key figures
*including research tax credit
ExonHit Therapeutics (Paris:ALEHT) today announced its consolidated
financial results for the year ending December 31, 2009.
Commenting on the results, Loïc Maurel, M.D., President of the
Management Board of ExonHit Therapeutics, said: “In 2009, we made
significant progress in our Alzheimer’s programs. We successfully
completed first patient dosing with EHT 0202, our lead candidate in
Alzheimer’s in therapeutics and in diagnostics, we launched our first
product, AclarusDx™ Alzheimer’s test.” He added: “We are starting 2010
with a strong cash position that will allow us to make the acquisition
of a US molecular diagnostic company and to prepare for the launch of
AclarusDx in the IVD market.”
Hervé Duchesne de Lamotte, ExonHit’s Chief Financial Officer since
November 2009, became a member of the Management Board in March 2010.
Overview of ExonHit’s business activities
ExonHit Therapeutics intends to remain active in both therapeutics and
diagnostics. These two fields have distinct risks and returns on
investment, and provide opportunities for synergistic value creation.
The Company has a specific approach for each domain.
In Therapeutics:
-
For its internal programs, the strategy of the Company is to bring
drug candidates through proof-of-concept studies, and then partner the
programs to accelerate product development. The milestone payments
received will allow ExonHit to finance the development of other drug
candidates and advance its diagnostics programs.
-
ExonHit is looking for additional research collaborations to further
leverage its discovery capabilities and expand its sources of
financing and revenues.
-
Starting in 2010, the company will focus its internal therapeutic
activities on cancer projects to take advantage of shorter development
timelines and earlier partnering opportunities than for
neurodegenerative diseases. Work in neurodegeneration will continue
with partners as demonstrated by the February 23, 2010 announcement
that proprietary ExonHit lead compounds from an internal neuro-related
program were being included into the Allergan collaboration.
In Diagnostics:
-
ExonHit intends to become recognized as a player in molecular
diagnostics which is a particularly attractive market with more rapid
development timelines than for therapeutics.
-
To strengthen its commercial portfolio, generate revenues rapidly and
hence, reach break-even faster, the Company announced it is planning
to acquire a revenue-generating US-based diagnostics company
specializing in molecular diagnostics with a focus in oncology and/or
neurodegeneration.
2010 will be a year of change for ExonHit. Assuming completion of the
planned diagnostic acquisition in the US in the second half of 2010, the
new global entity will have a commercial product portfolio and an
increased presence in the United States.
2009 consolidated financial results
Consolidated revenues amounted to € 4.9 million, an increase of 16%
compared to the € 4.2 million achieved in 2008. These increased revenues
mainly relate to the collaboration with Allergan under which more
activities were performed in 2009, combined with a stronger dollar
against the euro, all payments from Allergan being made in US dollars.
Research and Development expenses decreased by 9% to € 9.0 million in
2009 compared to € 9.9 million in 2008. The reduction is linked to a €
0.8 million loan that was forgiven by OSEO, a French government
organization dedicated to financing innovative R&D projects. Excluding
this loan, R&D expenses remained stable compared to 2008.
Marketing and Sales expenses amounted to € 1.2 million, an increase of
8% as compared to € 1.1 million in 2008, mainly driven by expenses for
market studies.
General and Administrative costs decreased by 6% to € 4.3 million in
2009, compared to € 4.6 million for the same period in 2008. This
decrease is linked to lower salary expenses subsequent to the CFO
leaving the company, partially offset by an increase in legal fees.
As a result, the group’s operating expenses decreased by 7% to € 14.6
million in 2009 compared to € 15.6 million in 2008. In 2009, 62% of
these expenses were allocated to R&D compared to 63% for the same period
in 2008.
Consequently, the company posted an operating loss of € 9.7 million for
2009, a decrease of 15% compared to € 11.4 million for 2008.
Financing income decreased to € 0.34 million in 2009 from € 0.38 million
in 2008. While financing costs decreased by 47%, following the
conversion of convertible bonds and the ensuing reduction in interest
payments, revenues also decreased by 22% due to lower cash reserves and
lower interest rates in 2009 compared to 2008.
The estimated research tax credit amounted to € 1.6 million in 2009,
compared to € 2.1 million in 2008. This decrease is essentially due to
the deduction of the forgiven OSEO loan.
As a consequence, ExonHit recorded a consolidated net loss of € 7.7
million in 2009, compared to € 8.9 million in 2008.
On December 31, 2009, the cash position of the Company amounted to €
30.2 million, compared to € 21.1 million at the end of 2008. ExonHit
cash is only invested in high quality funds which liquidity is
reasonably guaranteed.
Three financings took place in 2009, namely the conversion of more than
half of outstanding convertible bonds, the partial exercise of 08/09
warrants, and the December 2009 capital increase; in addition free
shares were granted in 2009 and stock-options were exercised during the
second half of 2009. As a result, total shareholder’s equity increased
to € 25.5 million on December 31, 2009 against € 9.7 million on December
31, 2008.
In 2009, ExonHit’s net cash utilized by operating activities was € 6.7
million compared to € 9.6 million in 2008. This decrease is mainly
related to the amount of the research tax credit reimbursed in cash to
the company during 2009. In order to help finance businesses, the French
Government changed R&D tax credit reimbursement rules and ExonHit
received a payment of € 3.6 million corresponding to the tax credit due
for the years 2005 to 2008.
Convertible bonds conversion is reflected by both a reduction of the
corresponding loan and a capital increase of € 7.0 million. In addition,
on December 18, 2009, the company issued 4,161,075 new common shares in
the context of a capital increase for € 15.6 million. As a result,
financing activities generated € 16.3 million in 2009, compared to € 0.2
million in 2008.
Product Update