Navigation Links
Amicus Therapeutics Announces Third Quarter 2007 Financial Results
Date:10/31/2007

CRANBURY, N.J., Oct. 31 /PRNewswire-FirstCall/ -- Amicus Therapeutics (Nasdaq: FOLD), a biopharmaceutical company developing small molecule, orally-active pharmacological chaperones for the treatment of human genetic diseases, today announced financial results for the third quarter of 2007. On a reported basis calculated in accordance with U.S. Generally Accepted Accounting Principles (GAAP), Amicus announced a net loss attributable to common stockholders per share of $0.46 for the three months ended September 30, 2007. On a non-GAAP basis, Amicus reported a net loss attributable to common stockholders per share of $0.41 for the three months ended September 30, 2007. As of September 30, 2007, cash, cash equivalents, and marketable securities totaled $119.4 million.

"We continue to be very pleased with the progress in all of our clinical programs and look forward to sharing the preliminary Phase II data from our lead programs for Amigal(TM) for Fabry disease and Plicera(TM) for Gaucher disease by yearend," stated John F. Crowley, CEO of Amicus Therapeutics.

Financial Results

On a reported basis, the net loss attributable to common stockholders for the three months ended September 30, 2007 was $10.3 million as compared to $11.7 million for the same period in 2006. On a non-GAAP basis, the net loss for the three months ended September 30, 2007 was $9.2 million as compared to $10.6 million and the same period in 2006. The Company recorded no revenues during these periods.

On a non-GAAP basis, research and development expense for the three months ended September 30, 2007, was $7.1 million, an increase of $0.9 million from $6.2 million for the three months ended September 30, 2006.

On a non-GAAP basis, general and administrative expense for the three months ended September 30, 2007, was $3.3 million, a decrease of $0.1 million from $3.4 million from the three months ended September 30, 2006.

The differences between U.S. GAAP EPS, net loss, research and development expense and general and administrative expense and the corresponding non-GAAP amounts are itemized in table 2 and 3, and are primarily due to:

-- Pre-tax share-based compensation expense under SFAS No. 123R of $1.1

million (or $0.05 per share) for the three months ended September 30,

2007, primarily related to employee stock option expense.

-- Pre-tax charges for preferred stock accretion.

-- Pre-tax charges for changes in the fair value of warrant liability.

Use of Non-GAAP Financial Measures

Our "non-GAAP net loss" and "non-GAAP diluted net loss per common share" financial measures are defined as reported, or GAAP, net loss and diluted net loss per common share excluding, for the reasons discussed below,

(1) Stock option expense and the cumulative effect of an accounting

change relating to the initial adoption of SFAS No. 123R and (2)

other items. Our management uses these non-GAAP financial measures to

establish financial goals and to gain an understanding of the

comparative financial performance of the Company from year to year

and quarter to quarter. Accordingly, we believe investors'

understanding of the Company's financial performance is enhanced as a

result of our disclosing these non-GAAP financial measures. Non-GAAP

net loss and diluted net loss per common share should not be viewed

in isolation or as a substitute for reported, or GAAP net loss and

diluted net loss per common share.

(2) Stock option expense - Non-GAAP net loss and diluted net loss per

common share exclude the impact of our stock option expense recorded

in accordance with SFAS No. 123R. We believe that excluding the

impact of expensing stock options better reflects the recurring

economic characteristics of our business.

(3) Other items - Non-GAAP net loss and diluted net loss per common

share exclude other unusual or non-recurring items that are evaluated

on an individual basis. Our evaluation of whether to exclude an item

for purposes of determining our non-GAAP financial measures considers

both the quantitative and qualitative aspects of the item, including,

among other things (i) its size and nature, (ii) whether or not it

relates to our ongoing business operations, and (iii) whether or not

we expect it to occur as part of our normal business on a regular

basis. Items excluded for purposes of determining non-GAAP net loss

and diluted net loss per common share include deemed dividends,

preferred stock accretion, and changes in the fair value of warrant

liability.

About Amicus Therapeutics

Amicus Therapeutics is a biopharmaceutical company developing novel, oral therapeutics known as pharmacological chaperones for the treatment of a range of human genetic diseases. Pharmacological chaperone technology involves the use of small molecules that selectively bind to and stabilize proteins in cells, leading to improved protein folding and trafficking, and increased activity. Amicus is initially targeting lysosomal storage disorders, which are severe, chronic genetic diseases with unmet medical needs. Amicus has two product candidates in Phase II clinical trials, Amigal(TM) for the treatment of Fabry disease and Plicera(TM) for the treatment of Gaucher disease. The Company is also conducting Phase I clinical trials of AT2220 for the treatment of Pompe disease.

Forward-Looking Statements

Amicus cautions you that statements included in the press release that are not a description of historical facts are "forward-looking statements" within the meaning of Section 21E of the Private Securities Litigation Reform Act of 1995. Words such as, but not limited to, "look forward to," "believe," "expect," "anticipate," "intend," "plan," "targets," "likely," "will," "would," "should" and "could" and similar expressions or words identify forward-looking statements. Such forward-looking statements are based upon current expectations that involve risks, changes in circumstances, assumptions and uncertainties. The inclusion of forward-looking statements should not be regarded as a representation by Amicus that any of its plans will be achieved. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions Amicus might make or by known or unknown risks and uncertainties. For example, with respect to statements regarding the potential progress and results of clinical trials, actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in the business of Amicus, including, without limitation: the respective Phase II clinical trials and data for Amigal(TM) and Plicera(TM), and the Phase I clinical trial for AT2220 may not proceed in the timeframes or in the manner Amicus expects or at all. Further, the results of earlier clinical trials may not be predictive of future results; Amicus and its licensors may not be able to obtain, maintain and successfully enforce adequate patent and other intellectual property protection of its product candidates; and other risks detailed in the public filings of Amicus with the Securities and Exchange Commission. You are cautioned no to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Amicus undertakes no obligation to revise or update this news to reflect events or circumstances after the date hereof.

Table 1

Amicus Therapeutics, Inc.

(a development stage company)

Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share amounts)

Period from

February 4, 2002

Three Months Nine Months (inception)to

Ended September 30, Ended September 30, September 30,

2006 2007 2006 2007 2007

Operating Expenses:

Research and

development $6,725 $7,537 $19,444 $21,404 $80,208

General and

administrative 3,783 3,954 8,247 9,994 32,786

Impairment of

leasehold

improvements - - - - 1,030

Depreciation and

amortization 245 315 661 924 2,481

In-process research

and development - - - - 418

Total operating

expenses 10,753 11,806 28,352 32,322 116,923

Loss from

operations (10,753) (11,806) (28,352) (32,322) (116,923)

Other income

(expenses):

Interest income 519 1,593 1,204 3,346 6,154

Interest expense (75) (90) (200) (269) (1,351)

Change in fair value

of warrant

liability (154) - (27) (149) (454)

Other expense (1,180) - (1,180) - (1,182)

Loss before tax

benefit (11,643) (10,303) (28,555) (29,394) (113,756)

Income tax benefit - - - - 695

Net loss (11,643) (10,303) (28,555) (29,394) (113,061)

Deemed dividend - - (19,424) - (19,424)

Preferred stock

accretion (41) - (122) (351) (802)

Net loss

attributable to

common

stockholders $(11,684) $(10,303) $(48,101) $(29,745) $(133,287)

Net loss

attributable

to common

stockholders per

common share

- basic and

diluted $(15.01) (0.46) (70.72) $(2.92)

Weighted-average

common shares

outstanding -

basic and

diluted 778,561 22,291,832 680,114 10,177,449

See accompanying notes to consolidated financial statements

Table 2

Amicus Therapeutics, Inc. Statement of Operations Information for Three Months Ended September 30, 2007

(In thousands, except share and per share amounts)

Change in

Fair

Value of Preferred

Warrant Stock Stock GAAP as

Non-GAAP Liability Accretion Compensation Reported

Income Statement

Classifications:

Research and

development $(7,090) $ - $ - $(447) $(7,537)

General and

administrative (3,293) (661) (3,954)

Depreciation

and amortization (315) (315)

Interest income 1,593 1,593

Interest expense (90) (90)

Summary:

Loss before income

taxes: (9,195) (1,108) (10,303)

Net loss: $(9,195) $ - $ - $(1,108) $(10,303)

Net loss per

share - basic and

diluted: $(0.41) $ - $ - $(0.05) $(0.46)

Weighted

average number

of shares

outstanding: 22,291,832 22,291,832

Table 3

Amicus Therapeutics, Inc. Statement of Operations Information for Three Months Ended September 30, 2006

(In thousands, except share and per share amounts)

Change in

Fair

Value of Preferred

Warrant Stock Stock GAAP as

Non-GAAP Liability Accretion Compensation Reported

Income Statement

Classifications:

Research and

development $(6,239) $ - $ - $(486) $(6,725)

General and

administrative (3,368) (415) (3,783)

Depreciation and

amortization (245) (245)

Interest income 519 519

Interest expense (75) (75)

Change in fair

value of

warrant

liability - (154) (154)

Other expense (1,180) (1,180)

Preferred stock

accretion - (41) (41)

Summary:

Loss before

income taxes: (10,588) (154) (41) (901) (11,684)

Net loss: $(10,588) $ (154) $ (41) $(901) $(11,684)

Net loss per

share - basic

and diluted: $(13.60) $(0.20) $(0.05) $(1.16) $(15.01)

Weighted average

number of shares

outstanding: 778,561 778,561


'/>"/>
SOURCE Amicus Therapeutics
Copyright©2007 PR Newswire.
All rights reserved

Related biology technology :

1. Canadian firm buys Proventiv Therapeutics, makes ex-Bone Care exec CEO
2. Speaker announces business members of IT Task Force
3. Doyle announces technology tax credits for Berbee
4. Doyle announces new energy, global warming policies
5. Doyle announces $80M renewable energy strategy
6. GE announces first installation of Discovery VCT
7. UWM announces winners of RGI awards
8. Third Wave announces two senior management appointments
9. Mirus announces new method for making antibodies
10. Merge announces sofware updates, upcoming acquisition
11. Small Tree announces ethernet solution for Apple Xserv G5
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... ... June 27, 2016 , ... Newly created ... services and solutions to the healthcare market. The company's primary focus is on ... sales and marketing strategies that are necessary to help companies efficiently bring their ...
(Date:6/24/2016)... on a range of subjects including policies, debt and investment ... Speaking at a lecture to the Canadian Economics ... the country,s inflation target, which is set by both the ... "In certain areas there needs to be frequent ... not sit down and address strategy together?" He ...
(Date:6/23/2016)... ... 23, 2016 , ... Mosio, a leader in clinical research ... Recruitment and Retention Tips.” Partnering with experienced clinical research professionals, Mosio revisits the ... tools, and strategies for clinical researchers. , “The landscape of how patients receive ...
(Date:6/23/2016)... 2016 A person commits a crime, and the ... track the criminal down. An outbreak of foodborne ... Administration (FDA) uses DNA evidence to track down the bacteria ... far-fetched? It,s not. The FDA has increasingly used a complex, ... foodborne illnesses. Put as simply as possible, whole genome sequencing ...
Breaking Biology Technology:
(Date:6/16/2016)... June 16, 2016 The ... expected to reach USD 1.83 billion by 2024, ... Research, Inc. Technological proliferation and increasing demand in ... expected to drive the market growth. ... The development of advanced multimodal techniques for ...
(Date:6/9/2016)... , June 9, 2016  Perkotek an innovation leader in attendance control systems ... seamlessly log work hours, for employers to make sure the right employees are actually ... http://photos.prnewswire.com/prnh/20160609/377486LOGO ... ... ...
(Date:6/7/2016)... TORONTO , June 7, 2016  Syngrafii ... begun a business relationship that includes integrating Syngrafii,s ... pilot branch project. This collaboration will result in ... for the credit union, while maintaining existing document ... http://photos.prnewswire.com/prnh/20160606/375871LOGO ...
Breaking Biology News(10 mins):