Filed by Bowne Pure Compliance
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 3, 2008
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 November 3, 2008, Amicus Therapeutics, Inc. issued a press release announcing its financial results for
the quarter ended September 30, 2008. 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.
(c) Exhibits .
99.1 Press Release, dated November 3, 2008
2
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: November 3, 2008
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By:
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/s/ GEOFFREY P. GILMORE |
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Name:
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Geoffrey P. Gilmore |
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Title:
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Senior Vice President and General Counsel |
3
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 November 3, 2008 |
4
Filed by Bowne Pure Compliance
Exhibit 99.1
Amicus Therapeutics Announces Third
Quarter 2008 Financial Results
Amicus Makes Steady Progress Toward Achievement of Milestones
Cranbury, NJ, November 3, 2008 Amicus Therapeutics (Nasdaq: FOLD) today announced financial
results for the third quarter of 2008. 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 $0.36 per share ($0.29 per share on a non-GAAP basis) for the three months ended
September 30, 2008. As of September 30, 2008, cash, cash equivalents, and marketable securities
totaled $136.3 million.
The third quarter of 2008 was another quarter of strong progress for Amicus as we focused on
clinical and regulatory execution on our three lysosomal storage disease programs, said John F.
Crowley, President and CEO of Amicus Therapeutics. In recent months, we have continued the process
with regulatory authorities in the United States and Europe in order to define the global
development plan for Amigal in Fabry, and we remain on track to provide an update by the end of
the year. In our Gaucher and Pompe disease programs, we continue to focus on advancing our ongoing
Phase 2 clinical trials with the goal of reporting data in Gaucher in 2009. Finally, our financial
position remains strong based on a healthy balance sheet and on the economics from our strategic
alliance with Shire, which funds 50% of development costs for our lead programs in addition to
success-based clinical and regulatory milestone payments.
Program Advancements
Fabry Disease:
Amigal (migalastat hydrochloride) is an investigational, oral therapeutic being developed for the
treatment of Fabry disease. Amicus, along with its partner Shire Human Genetic Therapies, Inc.
(Shire), is engaged in ongoing discussions with the U.S. Food and Drug Administration (FDA) and
the European Medicines Agency (EMEA) and will provide an update by the end of the year. A final
decision on the global development strategy will follow the conclusion of the discussions with both
agencies. Subject to the outcome of the discussions, the Company expects to initiate Phase 3
development of Amigal in the first half of 2009.
In addition, 23 of the original 26 patients continue to be treated in a voluntary Phase 2 extension
study designed to monitor long-term safety and efficacy and to evaluate additional doses and dose
regimens. Data from this extension study are expected in Q1 2009 prior to the start of the Phase 3
study.
Gaucher Disease:
Plicera (isofagomine tartrate) is an investigational, oral therapeutic in Phase 2 development for
the treatment of Gaucher disease. As previously disclosed, a 6-month Phase 2 clinical trial of
Plicera in patients naive to ERT is ongoing and Amicus expects the results of this study to be
available in 2009.
1
Pompe Disease:
AT2220 (1-deoxynojirimycin HCl) is an investigational, oral therapeutic being developed for the
treatment of Pompe disease. As previously disclosed, a Phase 2 clinical trial of AT2220 in adult
Pompe patients is ongoing and includes an 11 week treatment period with an optional extension
study.
In addition, Amicus is conducting preclinical animal studies to evaluate the effects of
administering AT2220 in combination with enzyme replacement therapy. Based on the results of the
preclinical work, Amicus will consider initiating a clinical trial of the AT2220-ERT combination
treatment in Pompe patients.
Other Chaperone Programs:
Amicus continues to invest in research and development to assess the potential for using
pharmacological chaperones to treat a broader range of human genetic diseases beyond lysosomal
storage 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. In September 2008, the Company entered into a lease for
laboratory space for a small scale research facility in San Diego, Calif. This facility will
complement Amicus core research and development activities in New Jersey, while allowing closer
access to the significant scientific and biotechnology resources in the San Diego community.
Shire 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. In this
collaboration, valued at up to $440 million including an up front payment and success based
clinical and sales milestones and excluding royalties and cost sharing, Shire 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
September 30, 2008, was $8.2 million as compared to $10.3 million for the same period in 2007. On a
non-GAAP basis, the net loss for the three months ended September 30, 2008, was $6.6 million as
compared to $9.2 million in the same period in 2007.
Amicus recorded revenue during the third quarter of 2008 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 third quarter 2008, Amicus recognized $0.7 million of the Shire upfront
payment and $3.0 million of research revenue on reimbursed research and development costs.
Amicus today reiterated its most recent guidance for 2008 cash burn of $40 million to $50 million.
The Company also reiterated that it does not expect to raise cash from any equity financings in
2008.
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.
2
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. |
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(2) |
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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. Amicus evaluation of
whether to exclude an item for purposes of determining its 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 its ongoing business
operations, and (iii) whether or not Amicus expects it to occur as part of its 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. |
Conference Call and Webcast
Amicus Therapeutics will host a conference call and webcast today, Monday, November 3, 2008, at
5:00 P.M. EST to review financial results and recent developments. Interested participants and
investors may access the conference call at 5 P.M. EST by dialing 877-419-6591 (U.S./Canada) or
719-325-4858 (international).
An audio webcast 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 90 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 888-203-1112 (U.S./Canada) and 719-457-0820 (international);
participant code 4499321.
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 completed Phase 2 clinical trials of Amigal for the
treatment of Fabry disease and is conducting Phase 2 clinical trials of Plicera for the treatment
of Gaucher disease and AT2220 for the treatment of Pompe disease.
3
Forward-Looking Statements
This Press release contains and the accompanying conference call will contain forward-looking
statements as that term is defined in 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. Examples of such statements include: (i)
statements regarding the goals, progress and expected timing of clinical studies, including the
progress, timing and design of Phase 3 clinical development for Amigal, the progress and timing of
the availability of data from the Phase 2 extension study of Amigal, the progress and timing of
Phase 2 clinical trials for Plicera for the treatment of Gaucher disease, the timing of the release
of data from the Phase 2 clinical trials for Plicera, the initiation of Phase 2 clinical
development of AT2220 for the treatment of Pompe disease, and the possibility and timing of
conducting clinical trials of AT2220 and ERT combination therapy; (ii) statements regarding the
timing and goals of discussions with US and EU regulatory authorities on the Phase 3 study and
regulatory pathway for Amigal; (iii) statements on the goals, progress and timing of preclinical
studies in Parkinsons disease and other research efforts aimed at evaluating disease targets in
neurodegenerative and other genetic disorders; (iv) statements on the range of cash burn for
Amicus in 2008, the need to raise additional capital in 2008 and the trends for incurring research
and development expense in 2008; and (v) statements regarding expected milestone and research
reimbursement payments from Shire. These forward looking statements are based on the current
estimates and assumptions of the management of Amicus as of the date of this press release and the
conference call and are subject to risks, changes in circumstances, assumptions and uncertainties
and other factors that may cause the actual results of Amicus to be materially different from those
reflected in the forward looking statements. Important factors that may cause actual results to
differ materially from those indicated by forward looking statements include, among others:
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the potential that results of clinical or preclinical studies indicate that product
candidates are unsafe or ineffective, |
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our dependence on third parties in the conduct of our clinical studies, |
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a change in strategy by our collaboration partners, |
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delays or failure to achieve final agreement with regulatory authorities on the design
of phase 3 program for Amigal and the regulatory pathway for approval of Amigal, |
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delays or failure to achieve regulatory approvals for our products, |
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risks of relying on third party manufacturers for the supply of our product candidates, |
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our or licensors inability to obtain, maintain and successfully enforce adequate patent
and other intellectual property protection of our product candidates, and |
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risks of collaborating with third parties to develop and commercialize products. |
These and other risks are described in greater detail in our Annual Report on Form 10-K for the
year ended December 31, 2007, and our other filings with the Securities and Exchange Commission.
You should not place undue reliance on these forward looking statements because of these
uncertainties, and the inclusion of forward-looking statements should not be regarded as a
representation by Amicus that any of its plans will be achieved. We assume no obligation to update
forward looking statements. This caution is made under the safe harbor provisions of Section 21E of
the Private Securities Litigation Reform Act of 1995.
CONTACTS:
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Investors:
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Media: |
John Quirk
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Amy Speak |
Porter Novelli Life Sciences
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Porter Novelli Life Sciences |
(212) 601-8296
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(617) 897-8262 |
FOLD -G
4
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, 2002 |
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(inception) |
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Three Months |
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Nine Months |
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to |
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Ended September 30, |
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Ended September 30, |
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September 30, |
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2007 |
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2008 |
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2007 |
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2008 |
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2008 |
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Revenue: |
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Research revenue |
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$ |
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$ |
2,959 |
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$ |
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$ |
8,539 |
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$ |
9,913 |
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Collaboration revenue |
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694 |
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2,083 |
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2,491 |
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Total revenue |
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3,653 |
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10,622 |
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12,404 |
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Operating Expenses: |
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Research and development |
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7,537 |
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8,200 |
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21,404 |
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23,989 |
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113,867 |
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General and administrative |
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3,954 |
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4,371 |
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9,994 |
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14,676 |
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52,745 |
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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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315 |
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382 |
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924 |
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1,036 |
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3,829 |
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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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11,806 |
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12,953 |
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32,322 |
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39,701 |
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171,889 |
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Loss from operations |
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(11,806 |
) |
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(9,300 |
) |
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(32,322 |
) |
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(29,079 |
) |
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(159,485 |
) |
Other income (expenses): |
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Interest income |
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1,593 |
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1,019 |
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3,346 |
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4,053 |
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11,993 |
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Interest expense |
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(90 |
) |
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(49 |
) |
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(269 |
) |
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(179 |
) |
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(1,608 |
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Change in fair value of
warrant liability |
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(149 |
) |
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(454 |
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Other expense |
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(1,180 |
) |
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Loss before tax benefit |
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(10,303 |
) |
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(8,330 |
) |
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(29,394 |
) |
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(25,205 |
) |
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(150,734 |
) |
Benefit from income taxes |
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150 |
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695 |
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Net loss |
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(10,303 |
) |
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|
(8,180 |
) |
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(29,394 |
) |
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(25,205 |
) |
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(150,039 |
) |
Deemed dividend |
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(19,424 |
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Preferred stock accretion |
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(351 |
) |
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(802 |
) |
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Net loss attributable to common
stockholders |
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$ |
(10,303 |
) |
|
$ |
(8,180 |
) |
|
$ |
(29,745 |
) |
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$ |
(25,205 |
) |
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$ |
(170,265 |
) |
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Net loss attributable to common
stockholders per
common share
basic and
diluted |
|
$ |
(0.46 |
) |
|
$ |
(0.36 |
) |
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$ |
(2.92 |
) |
|
$ |
(1.12 |
) |
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Weighted-average common shares
outstanding
basic and diluted |
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22,291,832 |
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22,517,431 |
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10,177,449 |
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22,465,981 |
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5
Table 2
Amicus Therapeutics, Inc.
Reconciliation of GAAP to non-GAAP Measures for the
Statement of Operations Information for Three Months Ended September 30, 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 |
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Compensation |
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Reported |
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Income Statement
Classifications: |
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Revenue |
|
$ |
3,653 |
|
|
|
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$ |
3,653 |
|
|
|
|
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|
|
|
|
|
|
|
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Research and development |
|
|
(7,597 |
) |
|
$ |
(603 |
) |
|
|
(8,200 |
) |
General and administrative |
|
|
(3,358 |
) |
|
|
(1,013 |
) |
|
|
(4,371 |
) |
Depreciation and amortization |
|
|
(382 |
) |
|
|
|
|
|
|
(382 |
) |
Interest income |
|
|
1,019 |
|
|
|
|
|
|
|
1,019 |
|
Interest expense |
|
|
(49 |
) |
|
|
|
|
|
|
(49 |
) |
(Provision for)/benefit from
income taxes |
|
|
150 |
|
|
|
|
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|
|
150 |
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Summary: |
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Net loss: |
|
$ |
(6,564 |
) |
|
$ |
(1,616 |
) |
|
$ |
(8,180 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Net loss per share basic
and diluted: |
|
$ |
(0.29 |
) |
|
$ |
(0.07 |
) |
|
$ |
(0.36 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of
shares outstanding: |
|
|
22,517,431 |
|
|
|
|
|
|
|
22,517,431 |
|
|
|
|
|
|
|
|
|
|
|
|
6
Table 3
Amicus Therapeutics, Inc.
Reconciliation of GAAP to non-GAAP Measures for the
Statement of Operations Information for Three Months Ended September 30, 2007
(Unaudited)
(In thousands, except share and per share amounts)
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Stock |
|
|
GAAP as |
|
|
|
Non-GAAP |
|
|
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: |
|
|
|
|
|
|
|
|
|
|
|
|
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 |
|
|
|
|
|
|
|
|
|
|
|
|
Source: FOLD -G
7