UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

WASHINGTON, D.C. 20549

FORM 8-K

CURRENT REPORT PURSUANT TO
SECTION 13 OR 15(D) OF THE
SECURITIES EXCHANGE ACT OF 1934

Date of Report (Date of earliest event reported): November 12, 2013

AMICUS THERAPEUTICS, INC.

(Exact Name of Registrant as Specified in Its Charter)

Registrant’s telephone number, including area code: (609) 662-2000

(Former Name or Former Address, if Changed Since Last Report.)

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

o Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)

o Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

o Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Item 2.02.  Results of Operations and Financial Condition.

On November 12, 2013, Amicus Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the quarter ended September 30, 2013. A copy of this press release is attached hereto as Exhibit 99.1.

In accordance with General Instruction B.2. of Form 8-K, the information in this Current Report on Form 8-K and the Exhibit shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liability of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.

Item 9.01. Financial Statements and Exhibits.

(d) Exhibits:  The Exhibit Index annexed hereto is incorporated herein by reference.

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SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

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EXHIBIT INDEX

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Exhibit 99.1

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, NJ, November 12, 2013 — 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.

CONTACTS:

Investors/Media:

Sara Pellegrino

spellegrino@amicusrx.com

(609) 662-5044

Table 1

Amicus Therapeutics, Inc.

(a development stage company)

Consolidated Statements of Operations

(Unaudited)

(In thousands, except share and per share amounts)

Table 2

Amicus Therapeutics, Inc.

(a development stage company)

Consolidated Balance Sheets

(Unaudited)

(in thousands, except share and per share amounts)

FOLD—G