Amicus Therapeutics Announces Third Quarter 2013 Financial Results

Amicus Therapeutics Announces Third Quarter 2013 Financial Results

   Reiterates Full-Year 2013 Net Cash Spend Guidance of $47 Million to $53
                                   Million

            Broad Strategic Update to be Provided by Year-End 2013

CRANBURY, N.J., Nov. 12, 2013 (GLOBE NEWSWIRE) -- Amicus Therapeutics
(Nasdaq:FOLD), a biopharmaceutical company at the forefront of therapies for
rare and orphan diseases, today announced financial results for the third
quarter ended September 30, 2013. A broad strategic update on the Company's
development programs and business development activities will be provided by
year-end 2013.

John F. Crowley, Chairman and Chief Executive Officer of Amicus Therapeutics
stated, "During the third quarter we continued to advance next-generation
enzyme replacement therapies in Fabry, Pompe and MPS I utilizing our CHART™
platform. In addition, our ongoing Phase 3 studies of migalastat HCl
monotherapy continued to advance toward further results in Fabry patients with
amenable mutations. Our balance sheet also remains strong through our
collaborations with GSK and Biogen, and with careful cost management. We look
forward to providing what we believe will be important and positive updates on
our portfolio and our future strategic direction in the coming weeks."

Financial Highlights for Third Quarter Ended September 30, 2013

  *Cash, cash equivalents, and marketable securities totaled $60.5 million at
    September 30, 2013 compared to $99.1 million at December 31, 2012.
  *Cash reimbursements received from GlaxoSmithKline (GSK) for shared
    development of migalastat HCl totaled $1.0 million compared to $3.7
    million in the third quarter 2012.
  *Total revenue of $39,000 consisted of research revenue received from
    Biogen Idec under the Parkinson's disease collaboration, which Amicus and
    Biogen entered on September 1, 2013. No revenue was recognized in the
    third quarter of 2012.
  *Total operating expenses decreased to $15.2 million from $16.9 million in
    the third quarter 2012 primarily due to lower expenses in research and
    development.
  *Net loss was $14.6 million, or $0.29 per share, compared to a net loss of
    $16.3 million, or $0.34 per share, for the third quarter 2012.

2013 Financial Guidance and Financial Outlook

Amicus continues to expect full-year 2013 net cash spend to total between $47
million and $53 million, including cash reimbursements received from GSK.
Amicus and GSK are responsible for 40% and 60% of global development costs for
migalastat HCl, respectively, in 2013 and beyond. The Company projects that
the current cash position and anticipated Fabry program reimbursements from
GSK are sufficient to fund operations into the fourth quarter of 2014.

Broad Strategic Update

Amicus expects to provide a broad strategic update on its development programs
and business development activities in the next few weeks. At this time Amicus
and GSK both remain blinded to the Stage 2 (12-month) data from the ongoing
Phase 3 study (Study 011) of migalastat HCl monotherapy in patients with Fabry
disease who have amenable mutations. In addition, all ongoing clinical studies
are continuing per protocol.

About Amicus Therapeutics

Amicus Therapeutics (Nasdaq:FOLD) is a biopharmaceutical company at the
forefront of therapies for rare and orphan diseases. The Company is developing
novel, first-in-class treatments for a broad range of human genetic diseases,
with a focus on delivering new benefits to individuals with lysosomal storage
diseases. Amicus' lead programs include the small molecule pharmacological
chaperones migalastat HCl as a monotherapy and in combination with enzyme
replacement therapy (ERT) for Fabry disease; and AT2220 (duvoglustat HCl) in
combination with ERT for Pompe disease.

Forward-Looking Statements

This press release contains "forward-looking statements" within the meaning of
the Private Securities Litigation Reform Act of 1995 relating to preclinical
and clinical development of Amicus' candidate drug products, the timing and
reporting of results from preclinical studies and clinical trials evaluating
Amicus' candidate drug products, and the projected cash position for the
Company. Words such as, but not limited to, "look forward to," "believe,"
"expect," "anticipate," "estimate," "intend," "potential," "plan," "targets,"
"likely," "may," "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 goals,
progress, timing and outcomes of discussions with regulatory authorities and
the potential goals, progress, timing and results of preclinical studies and
clinical trials, actual results may differ materially from those set forth in
this release due to the risks and uncertainties inherent in the business of
Amicus, including, without limitation: the potential that results of clinical
or pre-clinical studies indicate that the product candidates are unsafe or
ineffective; the potential that it may be difficult to enroll patients in our
clinical trials; the potential that regulatory authorities may not grant or
may delay approval for our product candidates; the potential that preclinical
and clinical studies could be delayed because we identify serious side effects
or other safety issues; the potential that we will need additional funding to
complete all of our studies and, our dependence on third parties in the
conduct of our clinical studies. Further, the results of earlier preclinical
studies and/or clinical trials may not be predictive of future results. With
respect to statements regarding projections of the Company's cash position,
actual results may differ based on market factors and the Company's ability to
execute its operational and budget plans. In addition, all forward looking
statements are subject to other risks detailed in our Annual Report on Form
10-K for the year ended December 31, 2012, as well as any subsequent quarterly
reports on Form 10-Q. You are cautioned not 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
release to reflect events or circumstances after the date hereof. This caution
is made under the safe harbor provisions of Section 21E of the Private
Securities Litigation Reform Act of 1995.

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
                                                             (inception)
                 Three Months           Nine Months            To
                 Ended September 30,     Ended September 30,     Sept.30,
                 2012        2013        2012        2013        2013
Revenue:                                                      
Research revenue  $--      $39        $11,591    $39        $57,532
Collaborationand --        --        6,820      --        64,382
milestone revenue
Total revenue     $--      $39        $18,411    $39        $121,914
                                                             
Operating                                                     
Expenses:
Research and      $11,499   $10,110   $39,226   $32,824   $348,717
development
General and       4,995      4,635      14,909     14,288     146,901
administrative
Restructuring     --        --        --        --        1,522
charges
Impairment of
leasehold         --        --        --        --        1,030
improvements
Depreciation and  422        429        1,284      1,318      13,086
amortization
In-process
research and      --        --        --        --        418
development
Total operating   16,916     15,174     55,419     48,430     511,674
expenses
Loss from         (16,916)   (15,135)   (37,008)   (48,391)   (389,760)
operations
Other income                                                  
(expenses):
Interest income   92         36         235        147        14,536
Interest expense  (19)       (7)        (77)       (26)       (2,448)
Change in fair
value of warrant  553        517        (1,941)    874        2,427
liability
Other income      --        --        21         --        252
Loss before tax   (16,290)   (14,589)   (38,770)   (47,396)   (374,993)
benefit
Income tax        --        --        --        --        8,708
benefit
Net loss          (16,290)   (14,589)   (38,770)   (47,396)   (366,285)
Deemed dividend   --        --        --        --        (19,424)
Preferred stock   --        --        --        --        (802)
accretion
Net loss
attributable to   $(16,290) $(14,589) $(38,770) $(47,396) $(386,511)
common
stockholders
Net loss
attributable to
common            $(0.34)   $(0.29)   $(0.88)   $(0.96)   
stockholders per
common share –
basic and diluted
                                                             
Weighted-average
common shares     48,513,647 49,621,188 44,255,885 49,621,188 
outstanding –
basic and diluted
                                                             

Table 2
Amicus Therapeutics, Inc.
(a development stage company)
Consolidated Balance Sheets
(Unaudited)
(in thousands, except share and per share amounts)


                                                   December 31, September 30,
                                                   2012         2013
Assets:                                                         
Current assets:                                                 
Cash and cash equivalents                           $33,971    $30,047
Investments in marketable securities                65,151      30,448
Receivable due from GSK                             3,225       2,121
Prepaid expenses and other current assets           2,270       1,692
Total current assets                                104,617     64,308
                                                               
Property and equipment, less accumulated
depreciation and amortization of $8,501 and $9,751  5,029       4,356
at December 31, 2012 and September 30, 2013,
respectively
Other non-current assets                            442         442
Total Assets                                        $110,088   $69,106
                                                               
Liabilities and Stockholders' Equity                            
Current liabilities:                                            
Accounts payable and accrued expenses               $8,845     $8,166
Current portion of secured loan                     398         398
Warrant liability                                   --         34
Total current liabilities                           9,243       8,598
                                                               
Deferredreimbursements                             30,418      34,019
Warrant liability, non-current                      908         --
Secured loan, less current portion                  299         --
                                                               
Commitments and contingencies                                   
                                                               
Stockholders' equity:                                           
Common stock, $.01 par value, 125,000,000 shares
authorized, 49,631,672 shares issued and            556         556
outstanding at December 31, 2012, 49,631,672 shares
issued and outstanding at September 30, 2013
Additional paid-in capital                          387,539     392,213
Accumulated other comprehensive income              14          5
Deficit accumulated during the development stage    (318,889)   (366,285)
Total stockholders' equity                          69,220      26,489
Total Liabilities and Stockholders' Equity          $110,088   $69,106

FOLD–G

CONTACT: Investors/Media:
         Sara Pellegrino
         spellegrino@amicusrx.com
         (609) 662-5044
 
Press spacebar to pause and continue. Press esc to stop.