Addex Pharmaceuticals Reports First Half 2008 Financial Results, Maiden Profit
2008-07-28 00:33:00
Addex Pharmaceuticals Reports First Half 2008 Financial Results, Maiden Profit
GENEVA, SWITZERLAND–(EMWNews – July 28, 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.
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.
Contacts
Chris Maggos |
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