Form 8-K
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): May 7, 2009
AMICUS THERAPEUTICS, INC.
(Exact name of registrant as specified in its charter)
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Delaware |
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001-33497 |
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71-0869350 |
(State or other Jurisdiction of Incorporation) |
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(Commission File Number) |
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(IRS Employer Identification No.) |
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6 Cedar Brook Drive, Cranbury, NJ
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08512 |
(Address of Principal Executive Offices) |
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(Zip Code) |
Registrants telephone number, including area code: (609) 662-2000
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(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))
1
Item 2.02. Results of Operations and Financial Condition.
On May 7, 2009, Amicus Therapeutics, Inc. issued a press release announcing its financial
results for the quarter ended March 31, 2009. 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, including Exhibit 99.1, 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.
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99.1 |
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Press Release, dated May 7, 2009 |
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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AMICUS THERAPEUTICS, INC.
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Date: May 7, 2009 |
By: |
/s/ GEOFFREY P. GILMORE
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Name: |
Geoffrey P. Gilmore |
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Title: |
Senior Vice President and General Counsel |
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EXHIBIT INDEX
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Exhibit No. |
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Description |
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99.1 |
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Press Release, dated May 7, 2009 |
Exhibit 99.1
Exhibit 99.1
Amicus Therapeutics Announces First Quarter
2009 Financial Results
Company Remains on Track to Advance Amigal for Fabry Disease into Phase 3 in Second Quarter
CRANBURY, N.J., May 7, 2009 Amicus Therapeutics (Nasdaq: FOLD) today announced financial results
for the first quarter 2009.
On a reported basis calculated in accordance with U.S. Generally Accepted Accounting Principles
(GAAP), Amicus announced a net loss attributable to common stockholders of $0.55 per share ($0.46
per share on a non-GAAP basis) for the three months ended March 31, 2009. As of March 31, 2009,
cash, cash equivalents, and marketable securities totaled $109 million.
Our first quarter was highlighted by positive Phase 2 extension data and continued progress
towards our final Phase 3 development plan for Amigal in Fabry Disease, said John F. Crowley,
Amicus President and CEO. We look forward to announcing our final protocol over the upcoming
weeks and starting the trial later this quarter.
Clinical Program Updates
Amigal (migalastat hydrochloride) for the treatment of Fabry disease
In the first quarter of 2009, Amicus continued to work closely with the U.S. and E.U. regulatory
authorities in an effort to finalize its Phase 3 development plan for Amigal. The Company remains
on track to announce the final Phase 3 protocol intended to support U.S. approval and to initiate
Phase 3 development of Amigal in the second quarter of 2009.
Additionally, in March 2009 at the American College of Medical Genetics (ACMG) 2009 Annual Meeting
in Tampa, FL, the Company presented positive results from its Phase 2 extension study with Amigal.
Amicus reported that treatment with Amigal was generally well-tolerated, with no drug-related
serious adverse events. The most common adverse events were headache, arthralgia and diarrhea.
Subjects identified as responders to Amigal at the completion of the Phase 2 studies continued to
maintain elevated levels of the target enzyme (a-Gal A), as measured in white blood cells, and
reduced levels of the target substrate (kidney GL-3), as measured in urine.
A reduction of GL-3 levels was also observed in interstitial capillary cells from kidney biopsies.
Previously reported Phase 2 results indicated that little to no GL-3 was detected in these cells in
most subjects prior to treatment with Amigal. The new data were obtained from the retesting of
biopsies using an improved methodology.
Preliminary results from the evaluation of modified doses and a new dosing regimen were also
presented.
Plicera (afegostat tartrate) for the treatment of Gaucher Disease
A Phase 2 clinical trial of the Companys investigational drug Plicera is ongoing. This 6-month
study is designed to evaluate safety and to demonstrate trends of efficacy, as measured by the
standard endpoints in Gaucher disease. The Company expects to report the results late in the third
quarter of 2009.
Amicus will continue to work closely with its partner, Shire HGT, to prepare for Phase 3
development of Plicera pending the results of the ongoing Phase 2 trial.
Furthermore, during the first quarter, the Company announced the issuance of United States Patent
No. 7,501,439, titled Tartrate Salt of Isofagomine and Methods of Use. The patent covers the
tartrate salt form of isofagomine, the active ingredient in the Plicera, and its use for the
treatment of Gaucher disease. The patent will expire in 2027.
AT2220 (1-deoxynojirimycin HCl) for the treatment of Pompe Disease
As previously reported, the Company suspended enrollment for the Phase 2 clinical trial of its
investigational drug AT2220 for the treatment of Pompe Disease and received notice from the U.S.
Food and Drug Administration (FDA) that the trial is on clinical hold.
The Company is currently evaluating all data and continues to work closely with the FDA to
determine appropriate next steps for advancing the development of AT2220.
The events have no impact on Amicus ongoing studies with Amigal for Fabry disease and
Plicera for Gaucher disease.
Preclinical Chaperone Programs
Amicus continues to invest in research and development to assess the potential for applying its
versatile chaperone technology platform to the treatment of a broader range of human genetic
diseases. As part of this effort, Amicus continues to conduct preclinical studies in Parkinsons
disease and is investing in new research aimed at evaluating disease targets for other
neurodegenerative and genetic disorders.
Shire HGT Collaboration
In November 2007, Amicus entered into a strategic collaboration with Shire Human Genetic Therapies,
Inc., a wholly-owned subsidiary of Shire plc, to jointly develop Amicus three lead pharmacological
chaperone compounds for lysosomal storage disorders, Amigal, Plicera and AT2220. Under the terms of
the collaboration Shire will pay development and sales milestones up to a maximum of $390 million,
and will also pay tiered, double digit royalties on net sales of the products. Shire also
reimburses world-wide development costs on a 50/50 basis, and in return Shire received rights to
commercialize these products outside of the U.S. while Amicus retains all rights to commercialize
these products in the U.S. In addition, Amicus leads development operations through the end of
Phase 2 clinical trials. The companies then share responsibility for Phase 3 clinical trial
development leveraging Shires significant ex-US regulatory and clinical experience as well as its
commercial infrastructure.
Additional Financial Results & Notes
On a reported basis, the net loss attributable to common stockholders for the three months ended
March 31, 2009, was $12.5 million as compared to $7.7 million for the same period in 2008. On a
non-GAAP basis, the net loss for the three months ended March 31, 2009, was $10.5 million as
compared to $6.4 million in the same period in 2008.
Amicus recorded revenue during the first quarter of 2009 representing two different revenue streams
from the Shire agreement. Upon signing the agreement, Amicus received an upfront payment of $50
million that will be recognized as revenue on a straight-line basis over 18 years from the date of
the agreement. In the first quarter of 2009, Amicus recognized $0.7 million of the Shire upfront
payment and $3.9 million of research revenue on reimbursed research and development costs.
The differences between U.S. GAAP and non U.S. GAAP financial results are itemized in Tables 2 and
3 and are primarily due to pre-tax stock compensation expense.
Use of Non-GAAP Financial Measures
Amicus 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 certain
items further discussed below. Amicus management uses these non-GAAP financial measures to
establish financial goals and to gain an understanding of the comparative financial performance of
Amicus from year to year and quarter to quarter. Accordingly, Amicus believes investors
understanding of Amicus financial performance is enhanced as a result of 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.
(1) |
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Stock option expense Non-GAAP net loss and diluted net loss per common share exclude the
impact of the stock option expense recorded in accordance with SFAS No. 123R. Amicus believes
that excluding the impact of expensing stock options better reflects the recurring economic
characteristics of its business. |
Conference Call and Webcast
Interested participants and investors may access the conference call at 5 p.m. EST by dialing
877-874-1565 (U.S./Canada) or 719-325-4830 (international). A telephonic replay of the call will be
available for seven days beginning at 8 p.m. EST. Access numbers for this replay are 888-203-1112
(U.S./Canada) and 719-457-0820 (international); participant code 5114983.
An audio webcast can also be accessed via the investor section of the Amicus Therapeutics Web site
at www.amicustherapeutics.com under Investors: Events and Presentations. Web participants
are encouraged to go to the Web site 15 minutes prior to the start of the call to register,
download and install any necessary software. After the live webcast, an audio webcast replay will
remain available in the Investors section of the Amicus Therapeutics Web site for 30 days.
Amicus press releases are available at www.amicustherapeutics.com
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 a strategic collaboration with Shire Human Genetic Therapies, Inc., a wholly-owned
subsidiary of Shire Limited, to develop and commercialize Amicus three lead pharmacological
chaperone compounds for lysosomal storage disorders. Under the agreement, Shire received commercial
rights outside of the United States. Amicus retains all U.S. rights.
Forward-Looking Statements
This press release contains and the accompanying conference call will contain forward-looking
statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such
as, but not limited to, look forward to, believe, expect, anticipate, estimate, 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 goals, progress,
timing and outcomes of ongoing discussions with regulatory authorities and the potential goals,
progress, timing and results of 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 inability to reach final agreement with regulatory
agencies on the phase 3 trial design for Amigal; the potential that results of clinical or
pre-clinical studies indicate that the product candidates are unsafe or ineffective; and, our
dependence on third parties in the conduct of our clinical studies. Further, the results of earlier
clinical trials may not be predictive of future results. Additionally, with respect to statements
regarding projections of the Companys cash position and expected use of cash during 2009, actual
results may differ based on market factors, the companys ability to execute its operational and
budget plans, and its achievement of milestones and receipt of milestone payments from Shire.
Additionally, all forward looking statements are subject to other risks detailed in our Annual
Report on Form 10-K for the year ended December 31, 2008, and our other public filings with the
Securities and Exchange Commission. 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.
CONTACT:
Investors:
Jenene Thomas
Director, Investor Relations
Amicus Therapeutics
609-662-5084
FOLD G
Table 1
Amicus Therapeutics, Inc.
(a development stage company)
Consolidated Statements of Operations
(Unaudited)
(In thousands, except share and per share amounts)
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Period from |
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Three Months |
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February 4, 2002 |
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Ended March 31, |
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(inception) to |
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2008 |
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2009 |
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March 31, 2009 |
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Revenue: |
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Research revenue |
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$ |
2,466 |
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$ |
3,912 |
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$ |
17,476 |
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Collaboration revenue |
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694 |
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694 |
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3,881 |
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Total revenue |
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3,160 |
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4,606 |
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21,357 |
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Operating Expenses: |
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Research and development |
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6,941 |
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11,875 |
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139,517 |
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General and administrative |
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5,186 |
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5,195 |
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62,931 |
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Impairment of leasehold
improvements |
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1,030 |
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Depreciation and amortization |
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321 |
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505 |
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4,792 |
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In-process research and
development |
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418 |
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Total operating expenses |
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12,448 |
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17,575 |
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208,688 |
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Loss from operations |
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|
(9,288 |
) |
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|
(12,969 |
) |
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|
(187,331 |
) |
Other income (expenses): |
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Interest income |
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1,702 |
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|
526 |
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|
13,286 |
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Interest expense |
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|
(70 |
) |
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|
(29 |
) |
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|
(1,677 |
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Change in fair value of warrant
liability |
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(454 |
) |
Other expense |
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|
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|
(1,180 |
) |
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Loss before tax benefit |
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|
(7,656 |
) |
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|
(12,472 |
) |
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|
(177,356 |
) |
(Provision for)/benefit from income
taxes |
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(75 |
) |
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695 |
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Net loss |
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|
(7,731 |
) |
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|
(12,472 |
) |
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|
(176,661 |
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Deemed dividend |
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(19,424 |
) |
Preferred stock accretion |
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(802 |
) |
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Net loss attributable to common
stockholders |
|
$ |
(7,731 |
) |
|
$ |
(12,472 |
) |
|
$ |
(196,887 |
) |
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Net loss attributable to common
stockholders per
common share basic and diluted |
|
$ |
(0.34 |
) |
|
$ |
(0.55 |
) |
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Weighted-average common shares
outstanding basic
and diluted |
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22,412,689 |
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22,613,850 |
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See accompanying notes to consolidated financial statements
Table 2
Amicus Therapeutics, Inc.
Reconciliation of GAAP to non-GAAP Measures for the
Statement of Operations Information for Three Months Ended March 31, 2009
(Unaudited)
(In thousands, except share and per share amounts)
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Stock |
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GAAP as |
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Non-GAAP |
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Compensation |
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Reported |
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Income Statement
Classifications: |
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Revenue |
|
$ |
4,606 |
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$ |
4,606 |
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Research and
development |
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(11,060 |
) |
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$ |
(815 |
) |
|
|
(11,875 |
) |
General and
administrative |
|
|
(4,038 |
) |
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|
(1,157 |
) |
|
|
(5,195 |
) |
Depreciation and
amortization |
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|
(505 |
) |
|
|
|
|
|
|
(505 |
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Interest income |
|
|
526 |
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|
|
|
|
|
|
526 |
|
Interest expense |
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|
(29 |
) |
|
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|
|
|
|
(29 |
) |
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Summary: |
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Net loss: |
|
$ |
(10,500 |
) |
|
$ |
(1,972 |
) |
|
$ |
(12,472 |
) |
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Net loss per share
- - basic and
diluted: |
|
$ |
(0.46 |
) |
|
$ |
(0.09 |
) |
|
$ |
(0.55 |
) |
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Weighted average
number of shares
outstanding: |
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22,613,850 |
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|
22,613,850 |
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Table 3
Amicus Therapeutics, Inc.
Reconciliation of GAAP to non-GAAP Measures for the
Statement of Operations Information for Three Months Ended March 31, 2008
(Unaudited)
(In thousands, except share and per share amounts)
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Stock |
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GAAP as |
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Non-GAAP |
|
|
Compensation |
|
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Reported |
|
Income Statement
Classifications: |
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|
|
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Revenue |
|
$ |
3,160 |
|
|
|
|
|
|
$ |
3,160 |
|
|
|
|
|
|
|
|
|
|
|
|
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Research and
development |
|
|
(6,412 |
) |
|
$ |
(529 |
) |
|
|
(6,941 |
) |
General and
administrative |
|
|
(4,368 |
) |
|
|
(818 |
) |
|
|
(5,186 |
) |
Depreciation and
amortization |
|
|
(321 |
) |
|
|
|
|
|
|
(321 |
) |
Interest income |
|
|
1,702 |
|
|
|
|
|
|
|
1,702 |
|
Interest expense |
|
|
(70 |
) |
|
|
|
|
|
|
(70 |
) |
(Provision
for)/benefit from
income taxes |
|
|
(75 |
) |
|
|
|
|
|
|
(75 |
) |
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Summary: |
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Net loss: |
|
$ |
(6,384 |
) |
|
$ |
(1,347 |
) |
|
$ |
(7,731 |
) |
|
|
|
|
|
|
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|
|
|
|
|
|
|
|
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|
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Net loss per share
- - basic and
diluted: |
|
$ |
(0.28 |
) |
|
$ |
(0.06 |
) |
|
$ |
(0.34 |
) |
|
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|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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|
Weighted average
number of shares
outstanding: |
|
|
22,412,689 |
|
|
|
|
|
|
|
22,412,689 |
|
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Source: FOLD -G