Addex Pharmaceuticals Reports First Half 2008 Financial Results, Maiden Profit
SOURCE:
Addex Pharmaceuticals
2008-07-28 00:23:00
Addex Pharmaceuticals Reports First Half 2008 Financial Results, Maiden Profit
GENEVA, SWITZERLAND–(EMWNews – July 28, 2008) –
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Geneva, Switzerland, 28 July 2008 – Addex Pharmaceuticals (SWX: ADXN)
released today financial results for the first half of 2008 and gave
an update on the status of its lead product, ADX10059, which is in
development for GERD (gastroesophageal reflux disease) and migraine.
Financial Highlights
* 1H08 net profit: CHF2.6 million
* 1H08 revenues: CHF25.8 million
* Cash and cash equivalents at June 30, 2008: CHF142.8 million
* Addex reiterates 2008 full year cash burn guidance of CHF25-30
million
Pipeline & Operating Highlights
* ADX10059 new formulation selected for Phase IIb GERD and migraine
prevention trials
* 2000 square meters of new lab space brought online and 30
additional staff hired
* Early launch of Inflammation Business Unit; Laurent Galibert
hired as head
Tim Dyer, CFO, said: “While we are proud to report our first
profitable period, which is primarily due to the recognition of $22
million in upfront fees from the sale of the license rights for
ADX63365 to Merck & Co., future profitability will be dependent on
the timing and structure of additional licensing activities and
potential milestones. We are excited to report that our expansion
plans are fully on track with the launch of our Inflammation Business
Unit getting under way during the first half and the continued
expansion of both the Metabolic and CNS Business Units proceeding
smoothly. As a result, spending in the first half of 2008 was in line
with our expectations and we reiterate our full year cash burn
guidance of CHF25-30 million.”
Key Financial Data 1H08 2H07 1H07 thousands of Swiss francs Revenues 25.8 0.2 0.4 R&D expenses (18.9) (14.9) (12.6) G&A expenses (3.5) (2.8) (7.9) Operating profit (loss) 3.4 (17.5) (20.1) Net financial income (0.8) 1.9 0.6 Net profit (loss) for the period 2.6 (15.6) (19.5) Basic and diluted net profit (loss) per share 0.45 (2.72) (4.55) Cash and cash equivalents 142.8 140.0 159.1
First Half 2008 Financial Summary
Revenues of CHF25.8 million consist primarily of $22 million of
upfront fees received from Merck & Co., Inc. under the mGluR5 PAM
license agreement signed in January and upfront and milestone
payments under the mGluR4 PAM collaboration which are being
recognized over the term of the collaboration.
Research & Development expenses increased to CHF18.9 million in the
first half of 2008 from CHF12.6 million in the first half of 2007
broadly reflecting the growth in our discovery and development
capabilities and the maturing preclinical and clinical product
pipeline.
General and Administration expenses decreased to CHF3.5 million in
the first half of 2008 compared to CHF7.9 million in the first half
of 2007, due primarily to the absence of the IPO related costs.
Excluding IPO related costs G&A has increased by 49% in line with
growth in R&D expenses.
Finance income increased to CHF1.9 million in the first half of 2008
from CHF0.6 million primarily due to higher levels of cash invested.
Financial expenses increased significantly to CHF2.7 million due to
unrealized exchange losses on the translation of USD cash balances.
Cash and cash equivalents amount to CHF142.8 million at the 30 June
2008, an increase of CHF2.8 million compared to the position at
year-end 2007.
Pipeline update
ADX10059, an mGluR5 NAM (metabotropic glutamate receptor 5 negative
allosteric modulator) in development for GERD and migraine
prevention, is advancing well. Addex announced in June that, based on
pre-defined pharmacokinetic criteria, it had chosen a new formulation
of ADX10059, for use in the Phase IIb GERD and migraine prevention
studies, which will start in the fourth quarter of 2008.
During 2007, ADX10059 met the primary endpoints in separate Phase IIa
proof of concept studies in patients with migraine and GERD.
Development of a more commercial formulation of ADX10059 began in
2007 and Phase I studies are ongoing. Safety, tolerability and
pharmacodynamic data from the ongoing ADX10059 Phase I studies (Study
104 & Study 105) will be communicated in September.
ADX48621, also an mGluR5 NAM, was well tolerated in an initial Phase
I study in healthy volunteers, Addex reported in 2007. A more
commercial formulation of ADX48621 is being prepared and the Phase I
program will be completed, using the new formulation, in the fourth
quarter of 2008. ADX48621, like ADX10059, has potential in multiple
indications, but Addex will develop it for levodopa associated
dyskinesia in Parkinson’s disease patients. Addex chose this niche
indication because the path to market is rapid and may not require
Addex to take a development or marketing partner. ADX48621 also can
serve as a backup to ADX10059 in GERD and migraine.
ADX63365, an mGluR5 PAM (positive allosteric modulator) with
potential in schizophrenia and undisclosed indications, has moved
into late stage preclinical development. Merck & Co. Inc. purchased
an exclusive worldwide license to develop and sell ADX63365 and
backups in January 2008.
ADX71943, a GABAB receptor PAM with potential for GERD, urinary
incontinence & pain, has moved into late stage preclinical
development and is on schedule to enter Phase I clinical trials in
the first half of 2009.
Operating review
As part of the expansion strategy, Addex announced at its R&D day in
April 2008 that it would broaden the implementation of its allosteric
modulation discovery and development platform to address clinically
validated targets in inflammation and metabolic diseases as well as
CNS indications. To achieve this, the company has organized itself
into three business units (CNS, Inflammation and Metabolic Disorders)
supported by shared Core Chemistry and Core Biology departments.
Addex made significant progress in implementing this new
organizational structure during the first half of 2008. To this end,
Addex announced in a separate press release today that Dr. Laurent
Galibert, formerly senior staff scientist at Merck Serono, has been
appointed head of the Inflammation Business Unit. In addition, Dr.
Emmanuel Le Poul, formerly head of biochemistry at Addex, has been
promoted to head of the CNS Business Unit. Both have joined the
executive management team.
Conference Call & Webcast
Title: Addex First Half 2008 Financial Results Conference Call Date: 28 July 2008 Time: 16:00 CET Dial-in numbers: +41 91 610 56 00 (Europe) +44 207 107 0611 (UK) +1 866 291 4166 (USA)
A live webcast and slides, as well as the webcast replay and
transcript, will be available at www.addexpharma.com.
About Addex
Addex Pharmaceuticals discovers and develops allosteric modulators
for human health. Allosteric modulators are an emerging class of
orally available small molecule therapeutic agents that we believe
will offer patients better results than classical drugs. Most
marketed drugs bind receptors where the body’s own natural molecular
activators (i.e. endogenous ligands) bind, specifically to a key part
of each receptor’s anatomy called the “active site”. In short, most
drugs must out-compete endogenous ligands for the active site. By
contrast, allosteric modulators are non-competitive because they bind
receptors and modify their function even if the endogenous ligand
also is binding it. In addition, because of this, allosteric
modulators aren’t limited to simply turning a receptor on or off, the
way most drugs are. Instead, they act more like a dimmer switch,
offering control over the degree of activation or deactivation, while
offering the body the ability to maintain control over initiating
receptor activation. Furthermore, the allosteric approach generally
affords freedom to operate – even on well-known, clinically validated
targets – because the intellectual property surrounding allosteric
chemistry and the allosteric sites on receptors is most often
un-exploited.
ADX10059, our most advanced product, is an mGluR5 NAM (metabotropic
glutamate receptor 5 negative allosteric modulator). It has
demonstrated clinically and statistically significant efficacy in
separate Phase IIa clinical trials in gastroesophageal reflux disease
(GERD) patients and migraine headache patients and has potential in
additional indications.
The Addex allosteric modulation discovery and development platform
have been additionally validated through three seperatate product
license or collaboration agreements with Merck & Co., Inc. and
Johnson & Johnson as well as investments by Roche Ventures and SR
One, the venture investment arm of GlaxoSmithKline.
Contacts Chris Maggos Head of IR & Communications Addex Pharmaceuticals +41 22 884 15 11 [email protected]
Disclaimer
The foregoing release contains forward-looking statements that can be
identified by terminology such as “not approvable”, “continue”,
“believes”, “believe”, “will”, “remained open to exploring”, “would”,
“could”, or similar expressions, or by express or implied discussions
regarding Addex Pharmaceuticals Ltd, its business, the potential
approval of its products by regulatory authorities, or regarding
potential future revenues from such products. Such forward-looking
statements reflect the current views of Addex Pharmaceuticals Ltd
regarding future events, and involve known and unknown risks,
uncertainties and other factors that may cause actual results with
allosteric modulators of mGluR4, mGluR2 or mGluR5 to be materially
different from any future results, performance or achievements
expressed or implied by such statements. There can be no guarantee
that allosteric modulators of mGluR4, mGluR2 or mGluR5 will be
approved for sale in any market or by any regulatory authority. Nor
can there be any guarantee that allosteric modulators of mGluR4,
mGluR2 or mGluR5 will achieve any particular levels of revenue (if
any) in the future. In particular, management’s expectations
regarding allosteric modulators of mGluR4, mGluR2 or mGluR5 could be
affected by, among other things, unexpected actions by our partners,
unexpected regulatory actions or delays or government regulation
generally; unexpected clinical trial results, including unexpected
new clinical data and unexpected additional analysis of existing
clinical data; competition in general; government, industry and
general public pricing pressures; the company’s ability to obtain or
maintain patent or other proprietary intellectual property
protection. Should one or more of these risks or uncertainties
materialize, or should underlying assumptions prove incorrect, actual
results may vary materially from those anticipated, believed,
estimated or expected. Addex Pharmaceuticals is providing the
information in this press release as of this date and does not
undertake any obligation to update any forward-looking statements
contained in this press release as a result of new information,
future events or otherwise.
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