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 July 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 2010 second quarter results and new partnership
agreements, dated July 28, 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:
July 28, 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 2010 second quarter results and new partnership
agreements, dated July 28, 2010, issued by Flamel Technologies
S.A.
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Flamel
Technologies Announces Three New Partnership Agreements; Second Quarter 2010
Results
LYON, France—July 28, 2010
--Flamel Technologies (Nasdaq:FLML) today announced three new partnership
agreements and its financial results for the second quarter of
2010. Highlights included:
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·
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Three
new agreements with two pharmaceutical
partners:
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o
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Two
agreements with a single partner involve the Micropump
platform;
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o
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A
third agreement for the development of a controlled release formulation
involving a peptide and a protein intended to treat metabolic
disease
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·
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Positive
advances in the Company’s work with Pfizer and Merck Serono;
and
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·
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Positive
cash-flow at constant-currency
rates.
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“Flamel
continued to advance on development programs this quarter with our existing
partners, while adding new projects into our feasibility pipeline. All of our
projects involving existing molecules continue to progress through pre-clinical
and clinical development. The already-marketed molecules on which we
are working to develop improved formulations with partners, together with
competitors within their respective classes, represented over $17 billion in
revenues in 2009,” commented Stephen H. Willard, Flamel’s chief executive
officer. “In addition, we believe that the applicability of the
Medusa platform in creating better formulations of biologics will continue to
gain considerable traction within the industry as our data become
available.”
Financial
Results
Flamel
reported total revenues in the second quarter 2010 of $7.5 million, compared to
$9.6 million in the year-ago period. License and research revenues
were $3.3 million versus $4.3 million in the second quarter of
2009. Product sales and services in the current quarter totaled $1.9
million versus $2.5 million in the second quarter of
2009. Other revenues during the current quarter,
including royalties on the sale of Coreg CR™, were $2.4 million versus $2.7
million in the year-ago period.
Costs and
expenses during the second quarter of 2010 were $(12.2) million versus $(13.2)
million in the year-ago period. Costs of goods and services sold in
the quarter totaled $(1.6) million versus $(1.9) million in the second quarter
of 2009. Research and development expenses were $(7.9) million versus
$(8.0) million in the second quarter of 2009. SG&A declined to
$(2.8) million from $(3.3) million in the year-ago period.
Net loss
in the second quarter of 2010 was $(4.3) million, compared to a net loss of
$(3.6) million in the second quarter of 2009. Net loss per share
(basic) for the second quarter of 2010 was ($0.18), compared to a net loss per
share (basic) in the year-ago period of ($0.15).
Cash and
marketable securities as of June 30, 2010 totaled $33.7 million versus $35.4
million as of March 31, 2010. The decline was entirely due to
currency translation effects; absent these, the Company grew cash during the
quarter by approximately $1.6 million.
For the
first half of 2010, Flamel reported total revenues of $15.6 million versus $21.6
million in the first half of 2009. License and research revenues during the
period were $6.7 million versus $11.4 million in the year-ago
period. Product sales and services during the first six months of
2010 were $4.2 million versus $5.0 million in the first half of
2009. Other revenues during the first six months of 2010 were $4.7
million versus $5.2 million in the year-ago period.
During
the first half of 2010, total costs and expenses were $(24.4) million, versus
$(24.1) million in the year-ago period. Costs of goods and services
sold in the first half of 2009 totaled $(3.5) million versus $(3.9) million in
the year-ago period. Research and development expenses during the
first half of 2010 were $(15.1) million versus $(13.9) million during the
year-ago period. SG&A for the first six months of 2010 amounted
to $(5.7) million versus $(6.2) million in the year-ago period.
Net loss
in the first half of 2010 was $(8.3) million, compared to a net loss of $(2.4)
million in the first half of last year. Net loss per share (basic and
diluted) for the first half of 2010 was $(0.34), compared to net loss per share
(basic and diluted) in the year-ago period of $(0.10).
A
conference call to discuss earnings is scheduled for 8:30 AM EDT July
29, 2010. The dial-in number (for investors in the U.S. and Canada)
is 877-719-9799; the conference ID number is 3585453. International
investors are invited to dial +1 719-325-4813.
The
conference call will also be webcast The webcast may be accessed at
www.flamel.com.
Flamel
Technologies, S.A. is a biopharmaceutical company principally engaged in the
development of two unique polymer-based delivery technologies for medical
applications. Micropump® is a
controlled release and taste-masking technology for the oral administration of
small molecule drugs. Flamel's Medusa®
technology is designed to deliver controlled-release formulations of proteins,
peptides, as well as other large and small molecules.
Charles
Marlio, Director of Strategic Planning and Investor Relations
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Tel:
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+
(33) (0)4-7278-3434
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Fax:
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+
(33) (0)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. These and other risks are described more fully in
Flamel's Annual Report on the Securities and Exchange Commission Form 20-F for
the year ended December 31, 2009.
Financial Statements
(Unaudited)
CONDENSED
CONSOLIDATED STATEMENT OF OPERATIONS (UNAUDITED)
(Amounts
in thousands of dollars except share data)
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Three
months ended June 30,
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Six months
ended June 30,
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2009
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2010
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2009
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2010
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Revenue:
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License
and research revenue
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$ | 4,341 | $ | 3,305 | $ | 11,430 | $ | 6,746 | ||||||||
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Product
sales and services
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2,529 | 1,860 | 4,951 | 4,165 | ||||||||||||
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Other
revenues
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2,705 | 2,350 | 5,248 | 4,691 | ||||||||||||
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Total
revenue
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9,575 | 7,515 | 21,629 | 15,602 | ||||||||||||
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Costs
and expenses:
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Cost
of goods and services sold
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(1,891 | ) | (1,585 | ) | (3,941 | ) | (3,510 | ) | ||||||||
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Research
and development
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(8,014 | ) | (7,861 | ) | (13,933 | ) | (15,122 | ) | ||||||||
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Selling,
general and administrative.
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(3,287 | ) | (2,797 | ) | (6,233 | ) | (5,728 | ) | ||||||||
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Total
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(13,192 | ) | (12,243 | ) | (24,107 | ) | (24,360 | ) | ||||||||
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Loss
from operations
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(3,617 | ) | (4,728 | ) | (2,478 | ) | (8,758 | ) | ||||||||
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Interest
income net..
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139 | 105 | 257 | 217 | ||||||||||||
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Foreign
exchange gain (loss)
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(74 | ) | 201 | (148 | ) | 215 | ||||||||||
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Other
income
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2 | 85 | 9 | 88 | ||||||||||||
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Loss
before income taxes.
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(3,550 | ) | (4,337 | ) | (2,360 | ) | (8,238 | ) | ||||||||
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Income
tax benefit (expense).
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- | 47 | - | (76 | ) | |||||||||||
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Net
loss.
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$ | (3,550 | ) | $ | (4,290 | ) | $ | (2,360 | ) | $ | (8,314 | ) | ||||
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Loss
per share
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Basic
loss per ordinary share.
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$ | (0.15 | ) | $ | (0.18 | ) | $ | (0.10 | ) | $ | (0.34 | ) | ||||
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Diluted
loss per share.
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$ | (0.15 | ) | $ | (0.18 | ) | $ | (0.10 | ) | $ | (0.34 | ) | ||||
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Weighted
average number of shares outstanding (in thousands) :
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Basic.
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24,220 | 24,408 | 24,213 | 24,375 | ||||||||||||
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Diluted
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24,220 | 24,408 | 24,213 | 24,375 | ||||||||||||