UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
Report
of Foreign Private Issuer
Pursuant
to Rule 13a-16 or 15d-16
of
the Securities Exchange Act of 1934
For the
month of March 2010
Commission
File Number 000-28508
Flamel
Technologies
(Translation
of registrant's name into English)
Parc
Club du Moulin à Vent
33
avenue du Dr. Georges Levy
69693
Vénissieux Cedex France
(Address
of principal executive offices)
Indicate by check mark whether the
registrant files or will file annual reports under cover of Form 20-F or Form
40-F.
Form 20-F
x Form 40-F
¨
Indicate by check mark whether
registrant by furnishing the information contained in this Form is also thereby
furnishing the information to the Commission pursuant to Rule 12g3-2(b) under
the Securities Exchange Act of 1934.
Yes ¨ No x
If "Yes" is marked, indicate below the
file number assigned to the registrant in connection with Rule
12g3-2(b): 82-____________
INFORMATION
FILED WITH THIS REPORT
Document
Index
99.1
Press Release regarding 2009 fourth quarter results, dated March 8, 2010, issued
by Flamel Technologies S.A.
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, thereunto duly
authorized.
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Flamel
Technologies, S.A.
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Dated:
8 March, 2010
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By:
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/s/ Stephen H. Willard
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Name: Stephen
H. Willard
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Title: Chief
Executive Officer
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EXHIBIT INDEX
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Exhibit
Number
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Description
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99.1
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Press
Release regarding 2009 fourth quarter results, dated March 8, 2010, issued
by Flamel Technologies
S.A.
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Flamel
Technologies Announces Fourth Quarter and Year-End 2009 Results
Fourth
quarter highlights include exercise of license option by Pfizer; initiation of
Phase IIa trial of Interferon-alpha XL; and increased number of new projects in
development.
Lyon, France – March 8, 2010 - Flamel
Technologies (NASDAQ: FLML) today announced its financial results for the
fourth quarter and year ended December 31, 2009.
Fourth Quarter
Highlights:
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·
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Pfizer
exercised the option to license the Medusa platform for development of an
improved intravenous formulation of an already-marketed molecule acquired
in its merger with Wyeth;
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·
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The
Company signed new feasibility studies applying the Medusa platform to
three new molecules with two top-ten pharmaceutical
companies;
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·
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The
Company announced that the Agence Nationale de Recherche sur le SIDA et
les Hépatites Virales (ANRS) initiated a twelve week study comparing two
dosage forms of IFN-alpha XL plus ribavirin versus Peg-Intron® plus
ribavirin in genotype 1 Hepatitis C
patients.
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Stephen
H. Willard, Flamel’s chief executive officer, stated, “Flamel continued to
expand its portfolio of projects with leading pharmaceutical companies during
the fourth quarter. We are now working with eight of the top twenty-five
pharmaceutical companies in the world. We have progressed in the projects
undertaken over the past two years, and expect that these projects will be the
subject of increased communication during the coming year.”
Mr.
Willard continued, “In 2009, Flamel continued to strengthen its balance sheet
and to diversify its revenue stream while increasing its cash position.
The work conducted by our scientists has resulted in the advancement of many of
our development programs during the year, as reflected by the higher license and
research revenues detailed in today’s announcement. The portfolio of
projects that we are currently developing is robust and reflects the progress
that we have made in expanding our intellectual property platforms and
leveraging these in partnership with leading companies such as Pfizer, Merck
Serono, Baxter, and GlaxoSmithKline, as well as others.”
Flamel’s Fourth Quarter
Results
Flamel
reported total revenues for the fourth quarter 2009 increased to $10.6 million
versus total revenues of $9.5 million in the year-ago period. The increase
was led by higher license and research revenue as well as product sales and
services, offset by lower Coreg CR royalties. License and research revenue
increased 37% to $4.7 million during the fourth quarter of 2009, versus $3.4
million in the fourth quarter of 2008. Product sales and services during
the period, related primarily to production of Coreg CR microparticles, were
$4.3 million versus $2.6 million during the year-ago period. Other
revenues, consisting primarily of royalty income from GSK on the sales of Coreg
CR, declined year-over-year to $1.7 million in the fourth quarter versus $3.4
million during the year-ago quarter.
Total
costs and expenses during the quarter were $16.5 million and included non-cash
compensation-related expense of $1.2 million; total costs and expenses in the
fourth quarter of 2008 were $12.4 million. Costs of goods and services
sold were $3.6 million in the fourth quarter of 2009 versus $2.4 million in the
year-ago period. Research and development costs in the fourth quarter totaled
$9.0 million versus $7.8 million in the year-ago period. Selling,
general, and administrative costs were $4.0 million in the fourth quarter versus
$2.3 million in the fourth quarter of 2008, which period included the reversal
of an accrual for SG&A related expenses of $2.0 million.
Net loss
for the fourth quarter of 2009 was ($5.7 million) versus a net loss of ($2.7
million) in the year-ago period. Net loss per share (basic) was ($0.23)
versus ($0.11) in the fourth quarter of 2008.
Flamel’s 2009 Annual
Results
For the
calendar year 2009, Flamel reported total revenue of $42.1 million, compared to
$38.6 million in 2008. License and research revenue during 2009 increased
57% to $20.8 million in 2009, as compared to $13.2 million in 2008.
Product sales and services for the year 2009 were $11.9 million, compared to
$13.5 million in the year-ago period. Other revenues, consisting primarily
of royalty income from sales of Coreg CR by GSK, totaled $9.4 million in 2009
versus $11.8 million in 2008.
Total
costs and expenses in 2009 were $53.9 million and included non-cash compensation
expense of $5.6 million. Total costs and expenses in 2008 totaled $51.8
million. Costs of goods and services sold were $10.1 million in 2009
versus $9.6 million in 2008. SG&A in 2009 totaled $13.3 million versus
$12.9 million in 2008. Research & development expenses were $30.4
million versus $29.3 million in 2008.
The
Company reported a net loss for the year 2009 of ($11.4 million) or ($0.47) per
share versus a net loss in 2008 of ($12.1 million), or ($0.50) per share.
Flamel finished 2009 with $44.1 million in cash and marketable securities as
compared to $37.1 million at the end of 2008.
About Flamel
Technologies
Flamel
Technologies is a drug delivery company with two intellectual property
platforms: Micropump, for the controlled release of drugs best absorbed in the
small intestine; and Medusa, for the controlled release of proteins, peptides,
and other molecules injected subcutaneously or administered intravenously.
Both of these platforms offer potential advantages with respect to efficacy and
the reduction of side-effects, in addition to the obvious benefits associated
with more convenient dosing regimens. For detailed company
information, including copies of this and other press releases, see Flamel’s web
site: www.flamel.com.
A
conference call to discuss these results is scheduled for 8:30 AM Eastern
Standard Time March 9, 2010. The dial-in number is (1) 877-857-6173 (Conference
ID number: 2453008).
International callers are invited to dial-in +1 719-325-4888.
Contact:
Charles
Marlio, Director of Strategic Planning and Investor Relations
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Tel:
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(011)
(33) 4-7278-3434
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Fax:
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(011)
(33) 4-7278-3435
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Marlio@flamel.com
This document contains a number of
matters, particularly as related to the status of various research projects and
technology platforms, that constitute forward-looking statements within the
meaning of the Private Securities Litigation Reform Act of 1995. The document
reflects the current view of management with respect to future events and is
subject to risks and uncertainties that could cause actual results to differ
materially from those contemplated in such forward-looking
statements. These risks include risks that
products in the development stage may not achieve scientific objectives or
milestones or meet stringent regulatory requirements, uncertainties regarding
market acceptance of products in development, the impact of competitive products
and pricing, and the risks associated with Flamel's reliance on outside parties
and key strategic alliances. We undertake no obligation to update these
forward-looking statements as a result of new information, future events or
otherwise. You should
not place undue reliance on these forward-looking statements. For further
information on the Company, please review Flamel's Annual Report on the
Securities and Exchange Commission Form 20-F for the year ended December 31,
2008.
Condensed
Consolidated Statements of Operations
(amounts
in thousands, except per share data)
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Three months ended
December 31,
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Twelve months ended
December 31,
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2008
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2009
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2008
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2009
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Revenue:
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License
and research revenue
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$ | 3,406 | $ | 4,659 | $ | 13,247 | $ | 20,815 | ||||||||
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Product
sales and services
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2,631 | 4,269 | 13,549 | 11,871 | ||||||||||||
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Other
revenues
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3,429 | 1,663 | 11,823 | 9,432 | ||||||||||||
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Total
revenue
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9,466 | 10,591 | 38,619 | 42,118 | ||||||||||||
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Costs
and expenses:
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Cost
of goods and services sold
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(2,358 | ) | (3,610 | ) | (9,621 | ) | (10,118 | ) | ||||||||
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Research
and development
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(7,835 | ) | (8,952 | ) | (29,269 | ) | (30,416 | ) | ||||||||
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Selling,
general and administrative
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(2,252 | ) | (3,966 | ) | (12,911 | ) | (13,337 | ) | ||||||||
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Total
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(12,445 | ) | (16,528 | ) | (51,801 | ) | (53,871 | ) | ||||||||
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Profit (loss)
from operations
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(2,979 | ) | (5,937 | ) | (13,182 | ) | (11,753 | ) | ||||||||
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Interest
income net
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287 | 76 | 1,414 | 425 | ||||||||||||
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Foreign
exchange gain (loss)
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(73 | ) | 205 | 3 | (83 | ) | ||||||||||
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Other
income (loss)
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22 | (41 | ) | 181 | (28 | ) | ||||||||||
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Income
(loss) before income taxes
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(2,743 | ) | (5,697 | ) | (11,584 | ) | (11,439 | ) | ||||||||
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Income
tax benefit (expense)
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17 | - | (500 | ) | - | |||||||||||
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Net
income (loss)
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$ | (2,726 | ) | $ | (5,697 | ) | $ | (12,084 | ) | $ | (11,439 | ) | ||||
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Earnings
(loss) per share
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Basic
earnings (loss) per ordinary share
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$ | (0.11 | ) | $ | (0.23 | ) | $ | (0.50 | ) | $ | (0.47 | ) | ||||
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Diluted
earnings (loss) per share
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$ | (0.11 | ) | $ | (0.23 | ) | $ | (0.50 | ) | $ | (0.47 | ) | ||||
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Weighted
average number of shares outstanding (in thousands) :
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Basic
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24,127 | 24,250 | 24,082 | 24,225 | ||||||||||||
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Diluted
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24,127 | 24,250 | 24,082 | 24,225 | ||||||||||||