Business News

Addex Pharmaceuticals Reports First Half 2008 Financial Results, Maiden Profit

SOURCE:

Addex Pharmaceuticals

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
Head of IR & Communications
Addex Pharmaceuticals
+41 22 884 15 11
[email protected]

free cash grants, free grant money, free money, cash grants, scholarships, business grants, foundation grants, government grants, debt grants, consolidation, college tuition, financial aid, medical grants, personal grants, medical bills, unsecured loans, no interest loans, financing, loans, capital, non profit organizations

Major Newsire & Press Release Distribution with Basic Starting at only $19 and Complete OTCBB / Financial Distribution only $89

Get Unlimited Organic Website Traffic to your Website 
TheNFG.com now offers Organic Lead Generation & Traffic Solutions





























Jerry Cruz

Tops SEO Expert, Social Media Influencer and Editor. Having published and edited more than 4700+ Articles in the last 6 years definately a PRO!

Related Articles

Back to top button