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): February 14, 2011
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 |
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(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 |
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(Address of principal executive offices)
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(Zip Code) |
Registrants 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:
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Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |
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Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |
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Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |
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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 February 14, 2011, Amicus Therapeutics, Inc. issued a press release announcing its
financial results for the quarter and year ended December 31, 2010. 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.
(d) Exhibits: The Exhibit Index annexed hereto is incorporated herein by reference.
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: February 14, 2011 |
By: |
/s/ Geoffrey P. Gilmore
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Geoffrey P. Gilmore |
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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 February 14, 2011 |
EX-99.1
Exhibit 99.1
Amicus Therapeutics Announces Fourth Quarter
and Full Year 2010 Financial Results
Company expects to achieve multiple key milestones advancing rare disease product pipeline during 2011
CRANBURY, N.J., February 14, 2010 Amicus Therapeutics (Nasdaq: FOLD) today announced financial
results for the fourth quarter and full year 2010. The Company also provided a review of planned
key milestones for 2011, which includes the announcement of top line results from the ongoing Phase
3 Study of Amigal (migalastat HCl) for Fabry Disease.
Fourth Quarter and Full-Year 2010 Financials Summary
Amicus announced net loss attributable to common stockholders of $0.48 per share for the three
months ended December 31, 2010. For the year ended December 31, 2010, the net loss attributable to
common stockholders was $1.98 per share. As of December 31, 2010, cash, cash equivalents, and
marketable securities totaled $107.4 million.
We have started 2011 on a very positive note and intend to build on our momentum through the
achievement of multiple key milestones across all of our programs during the year, said John F.
Crowley, Chairman and CEO of Amicus. We are advancing and expanding the use of pharmacological
chaperone technology and as a result have established ourselves as a leader in the development of
new treatments for rare diseases.
2011 Key Milestones
In 2011 Amicus expects to achieve multiple key milestones across its three areas of focus: Amigal
(migalastat HCl) for the treatment of Fabry Disease, the evaluation of pharmacological chaperones
co-administered with enzyme replacement therapy (ERT), and the investigation of pharmacological
chaperones for the treatment of diseases of neurodegeneration. Among the milestones expected this
year are results from the following studies:
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Phase 3 study of Amigal for Fabry Disease in 2H11 |
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Phase 2 study of Amigal co-administered with ERT for Fabry Disease in 2H11 |
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Phase 2 study of AT2220 co-administered with ERT for Pompe Disease in 2H11 |
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Late-stage preclinical proof of concept studies of AT3375 for Parkinsons Disease,
including completion of additional IND-enabling activities, in 2H11. |
Amigal (migalastat HCl) for the Treatment of Fabry Disease
On October 29, 2010, Amicus announced a definitive agreement with GlaxoSmithKline PLC (GSK) to
develop and commercialize Amigal (migalastat HCl), currently in Phase 3 for the treatment of Fabry
disease. Under the terms of the agreement, GSK received an exclusive worldwide license to develop,
manufacture and commercialize migalastat HCl. Additionally, as part of the agreement, GSK and
Amicus also intend to advance clinical studies exploring the co-administration of migalastat HCl
with ERT for the treatment of Fabry disease.
The Phase 3 study (Study 011) of migalastat HCl remains the Companys number one priority. Study
011 is ongoing and patients are being enrolled at 36 investigational sites worldwide. A majority
of the planned 60 patients have been enrolled in the study. The Company expects to complete
enrollment in the first half of 2011 and to report preliminary results from this study in the
second half of the year.
Amicus and GSK intend to commence an additional Phase 3 study (Study 012) in the first half of
2011. Study 012 will be an 18-month, randomized, open-label study comparing migalastat HCl to
enzyme replacement therapy (ERT) in approximately 60 subjects. The primary outcome of efficacy will
be renal function as measured by glomerular filtration rate (GFR).
Seventeen subjects continue to receive treatment in the ongoing Phase 2 long-term extension study.
Amicus plans to provide a data update from this study at the Lysosomal Disease Network WORLD
Symposium in Las Vegas, Nevada February 16-18th, 2011.
Chaperone-ERT Combination Therapy
Amicus previously reported promising preclinical data demonstrating that the co-administration of a
pharmacological chaperone with ERT has the potential to address key limitations of ERT. The
addition of a pharmacological chaperone has been shown to prevent the loss of activity of ERT in
the circulation, increase tissue uptake, and increase substrate reduction. Preclinical proof of
concept has been established for Fabry disease and Pompe disease. Amicus plans to present a review
of historical and new data from these studies at the Lysosomal Disease Network WORLD Symposium in
Las Vegas, Nevada February 16-18th, 2011.
Amicus and its partner GSK are sponsoring an ongoing Phase 2 study evaluating the co-administration
of migalastat HCl with ERT for Fabry disease. Results from this study are expected in the second
half of 2011.
Additionally, the Company expects to initiate a Phase 2 study with its pharmacological chaperone
AT2220 co-administered with ERT for Pompe disease in the first half of 2011 and expects results
from this study to be available in the second half of the year. The Company intends to seek U.S.
FDA approval to lift the current hold on the AT2220 program as part of its development plan.
Diseases of Neurodegeneration
Amicus is investigating the potential use of pharmacological chaperones for the treatment of
genetically defined sub-populations of patients with Parkinsons Disease and Alzheimers Disease.
Amicus previously reported encouraging results from preclinical studies evaluating the use of a
pharmacological chaperone for the treatment of Parkinsons Disease. In 2011 it expects to complete
late-stage preclinical proof of concept studies, including IND-enabling activities, for its
molecule AT3375, which is in development for the treatment of Parkinsons Disease. The Amicus
Parkinsons Disease program is funded in part by a grant from The Michael J. Fox Foundation (MJFF).
Additionally, Amicus continues to advance its preclinical program evaluating a pharmacological
chaperone approach for the treatment of Alzheimers disease. The Company expects to continue
preclinical proof of concept studies during 2011. The Amicus Alzheimers Disease program is funded
in part by a grant from the Alzheimers Drug Discovery Foundation (ADDF).
Amicus plans to present new information from both its Parkinsons Disease and Alzheimers Disease
programs at the Lysosomal Disease Network WORLD Symposium in Las Vegas, Nevada February
16-18th, 2011.
2011 Financial Guidance
As previously reported, the Company expects to spend a total of $45 to $55 million on 2011
operating expenses, net of cost sharing and milestones related to the GSK collaboration. The
current cash position, including anticipated payments from GSK in connection with the
collaboration, is expected to be sufficient to fund the Companys operations and capital
expenditure requirements through the anticipated commercial launch of Amigal in the United States.
In 2011, the Company will continue to evaluate additional business development opportunities to
further build shareholder value. The Company is actively exploring a range of opportunities with
multiple potential partners.
Additional Financial Results & Notes
Net loss attributable to common stockholders for the three months ended December 31, 2010, was
$15.1 million as compared to a net income of $33.0 million for the same period in 2009, which
included recognition of $45 million of previously deferred revenue on the upfront payment we
received from our prior partner, Shire, in 2007.
Upon the signing the GSK collaboration agreement, Amicus received an upfront payment of $30 million
and a premium of $3.2 million related to GSKs purchase of an equity investment in Amicus. The
total upfront consideration received of $33.2 million will be recognized as revenue on a
straight-line basis over the development period of the collaboration agreement which is
approximately 5.2 years. In the fourth quarter of 2010, Amicus recognized $0.9 million of the
total upfront consideration as Collaboration Revenue.
Conference Call and Webcast
Amicus Therapeutics will host a conference call and webcast today, Monday, February 14, 2010, at
5:00 P.M. EST to review financial results and provide a corporate update. Interested participants
and investors may access the conference call at 5 p.m. EST by dialing 877-303-5859 (U.S./Canada) or
678-224-778 (international).
An audio webcast and archive can also be accessed via the investor section of the Amicus
Therapeutics Web site at http://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, a
webcast replay will remain available in the Investors section of the Amicus Therapeutics Web site
for 30 days.
A telephonic replay of the call will be available for seven days beginning at 8 p.m. EST. Access
numbers for this replay are 800-642-1687 (U.S./Canada) and 706-645-9291
(international); participant code 43466317.
Amicus press releases are available at www.amicustherapeutics.com.
About Amicus Therapeutics
Amicus Therapeutics is a biopharmaceutical company focused on developing treatments for rare
diseases. The Company is developing orally-administered, small molecule drugs called
pharmacological chaperones, a novel, first-in-class approach to treating a broad range of diseases
including lysosomal storage disorders and diseases of neurodegeneration. Amicus lead program is
in Phase 3 for the treatment of Fabry disease.
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 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,
the projected cash position for the Company, including achievement of development and
commercialization milestone payments and sales royalties under our collaboration with
GlaxoSmithKline, and business development and other transactional activities that seek to
strengthen the Companys financial position. 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 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 Companys cash position, actual results may differ based on
market factors and the Companys ability to execute its operational and budget plans, including
achievement of development and commercialization milestone payments and sales royalties under our
collaboration with GlaxoSmithKline. Additionally, with respect to statements relating to potential
business development opportunities and other transactions that seek to strengthen our financial
position, we may not be successful in identifying suitable collaborators, establishing and
implementing such collaborations or completing other transactions that could improve our financial
position. 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, 2009. 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:
ir@amicustherapeutics.com
(609) 662-2000
FOLDG
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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February 4, |
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2002 |
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(inception) |
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Three Months |
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Twelve Months |
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to |
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Ended December 31, |
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Ended December 31, |
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Dec 31, |
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2009 |
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2010 |
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2009 |
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2010 |
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2010 |
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Revenue: |
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Research revenue |
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$ |
4,746 |
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$ |
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$ |
17,545 |
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$ |
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$ |
31,108 |
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Collaboration revenue |
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44,730 |
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922 |
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46,813 |
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922 |
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50,922 |
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Total revenue |
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49,476 |
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922 |
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64,358 |
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922 |
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82,030 |
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Operating Expenses: |
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Research and development |
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10,126 |
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13,154 |
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48,081 |
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39,042 |
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214,764 |
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General and administrative |
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4,338 |
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3,823 |
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19,973 |
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15,660 |
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93,369 |
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Restructuring charges |
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1,522 |
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1,522 |
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1,522 |
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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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548 |
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481 |
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2,132 |
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2,058 |
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8,478 |
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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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16,534 |
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17,458 |
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71,708 |
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56,760 |
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319,581 |
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Income/(loss) from operations |
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32,942 |
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(16,536 |
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(7,350 |
) |
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(55,838 |
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(237,551 |
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Other income (expenses): |
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Interest income |
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73 |
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35 |
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997 |
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156 |
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13,913 |
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Interest expense |
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(123 |
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(57 |
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(278 |
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(260 |
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(2,185 |
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Change in fair value of warrant liability |
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(946 |
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(1,410 |
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(1,864 |
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Other income |
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64 |
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1,277 |
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64 |
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1,277 |
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161 |
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Income/(loss) before tax benefit |
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32,956 |
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(16,227 |
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(6,567 |
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(56,075 |
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(227,526 |
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Benefit from income taxes |
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1,139 |
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1,139 |
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1,834 |
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Net Income/(loss) |
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32,956 |
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(15,088 |
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(6,567 |
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(54,936 |
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(225,692 |
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Deemed dividend |
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(19,424 |
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Preferred stock accretion |
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(802 |
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Net Income/(loss) attributable to common stockholders |
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$ |
32,956 |
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$ |
(15,088 |
) |
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$ |
(6,567 |
) |
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$ |
(54,936 |
) |
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$ |
(245,918 |
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Net Income/(loss) attributable to common stockholders per
common share basic |
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$ |
1.46 |
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$ |
(0.48 |
) |
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$ |
(0.29 |
) |
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$ |
(1.98 |
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diluted |
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$ |
1.45 |
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$ |
(0.48 |
) |
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$ |
(0.29 |
) |
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$ |
(1.98 |
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Weighted-average common shares outstanding basic |
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22,643,507 |
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31,320,453 |
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22,624,134 |
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27,734,797 |
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diluted |
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22,781,090 |
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31,320,453 |
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22,624,134 |
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27,734,797 |
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Source: FOLD -G