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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) –

Français (PDF): http://hugin.info/138017/R/1238552/265045.pdf

Deutsch (PDF): http://hugin.info/138017/R/1238552/265046.pdf

English (PDF): http://hugin.info/138017/R/1238552/265047.pdf

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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