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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 August 2007
Commission File Number 000-28508
Flamel Technologies S.A.
(Translation of registrants 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.
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.
If Yes is marked, indicate below the file number assigned to the registrant in connection
with Rule 12g3-2(b): 82-___
TABLE OF CONTENTS
INFORMATION FILED WITH THIS REPORT
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Document Index |
99.1
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Press Release, dated August 1, 2007, 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: August 2, 2007 |
By: |
/s/ Stephen Willard
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Name: |
Stephen Willard |
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Title: |
Chief Executive Officer |
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EXHIBIT INDEX
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Exhibit |
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Number |
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Description |
99.1
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Press Release, dated August 1, 2007, issued by Flamel Technologies S.A. |
exv99w1
Exhibit 99.1
For Immediate Release
Flamel Technologies Announces Second Quarter Results, New Medusa Relationships, and Ongoing Work on COREG CR®
LYON, FranceAugust 1, 2007Flamel Technologies (Nasdaq:FLML) today announced its financial
results for the second quarter of 2007.
Flamel reported total revenues of $7.4 million, compared to $4.7 million in the second quarter of
2006. Product sales and services totaled $4.8 million during the quarter. License and research
revenues were $1.8 million versus $4.5 million in the year-ago period. Other revenues were $0.8
million versus $0.2 million in the year-ago period.
Costs and expenses during the second quarter were $(21.5) million versus $(14.3 million) in the
year-ago period. Costs of goods and services sold in connection with the manufacture of COREG CR
microparticles totaled $(3.7) million versus $(1.2) million in the second quarter of 2006.
Research and development expenses were $(13.2) million versus $(9.0) million in the second quarter
of 2006. SG&A was $(4.6) million up from $(4.1) million in the year-ago period.
Total costs and expenses less costs of goods and services sold (which are performed under a
cost-plus contract with GSK) were $(17.8) million versus $(13.1) million in the year-ago quarter.
Non-cash effects such as the unfavorable evolution of the dollar-euro exchange rate, as well as
increased expenses relating to FAS-123R represented $2.1 million of the difference between the two
periods. The remainder related to increased expenses relating to pre-clinical and clinical trials.
Net loss in the second quarter of 2007 was $(13.6) million, compared to a net loss of $(9.5)
million in the second quarter of last year. Net loss per share (basic) for the second quarter of
2007 was ($0.57), compared to a net loss per share (basic) in the year-ago period of ($0.40).
Cash and marketable securities at the end of the second quarter totaled $47 million.
For the first half of 2007, Flamel reported total revenues of $17.1 million versus $9.8 million, in
the first half of 2006. License and research revenues during the period were $4.9 million versus
$9.4 million in the year-ago period. Product sales and services during the first six months of
2007 were $10.2 million. Other revenues during the first six months of 2007 were $1.9 million
versus $0.4 million in the year-ago period.
During the first six months of 2007, total costs and expenses were $(40.6) million versus $(29.6)
million in the first six months of 2006. Costs of goods and services sold relating to the
manufacture of COREG CR microparticles totaled $(8.2) million versus $(3.1) million in the year-ago
period. Research and development expenses during the first half of 2007 were $(23.8) million
versus $(18.5) million during the year-ago period. Net of the effect of the dollar-euro exchange
rate and increased stock-compensation expense associated with FAS 123-R, research and development
costs increased by $2.5 million during the period. SG&A totaled $(8.7) million versus $(8.0)
million in the first six months of 2006. Net of the non-cash effects of the unfavorable exchange
rate during the quarter, as well as increased costs associated with FAS-123R, SG&A during the
period actually decreased by $(0.3) million.
Net loss in the first half of 2007 was $(22.7) million, compared to a net loss of $(19.1) million
in the first half of last year. Net loss per share (basic) for the first half of 2007 was $(0.95),
compared to net loss per share (basic) in the year-ago period of $(0.80).
Flamel has recently entered into further new relationships for its Medusa platform, said Stephen
Willard, Flamels Chief Executive Officer. We believe that further potential agreements for other
molecules are progressing well and that we are creating a diversified set of opportunities for our
Medusa platform. The Phase I clinical trial on the new formulation of Basulin, our long-acting
basal insulin, has commenced, and we continue to expect that it will be completed by the end of the
third quarter. Regarding COREG CR, we believe it has strong ongoing potential in all indications.
We continue to manufacture at the maximum rate and expect to do so even after the addition of new
manufacturing capacity.
A conference call to discuss earnings is scheduled for 8:30 AM EDT August 2, 2007. The dial-in
number (for investors in the U.S. and Canada) is 1-800-374-1498; the conference ID number is
10297673. International investors are invited to dial 1-706-634-7261.
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. Flamels Medusa® technology is designed to deliver controlled-release
formulations of therapeutic proteins and peptides.
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Contact: |
Flamel Technologies S.A. |
Michel Finance, Chief Financial Officer |
Tel::
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(33)(0)4-7278-3434 |
Fax:
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(33)(0)4-7278-3434 |
Finance@flamel.com |
or
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Charles Marlio, Director of Strategic Planning and Investor Relations |
Tel:
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(33)(0)4-7278-3434 |
Fax:
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(33)(0)4-7278-3434 |
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 presentation 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 Flamels reliance on outside parties and key strategic alliances.
These and other risks are described more fully in Flamels Annual Report on the Securities and
Exchange Commission Form 20-F for the year ended December 31, 2006.
Schedule attached
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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2006 |
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2007 |
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2006 |
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2007 |
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Revenue: |
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License and research revenue |
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$ |
4,550 |
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$ |
1,794 |
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$ |
9,401 |
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$ |
4,918 |
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Product sales and services |
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4,818 |
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19 |
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10,218 |
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Other revenues |
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185 |
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837 |
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413 |
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1,938 |
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Total revenue |
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4,735 |
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7,449 |
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9,833 |
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17,074 |
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Costs and expenses: |
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Cost of goods and services sold |
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(1,204 |
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(3,699 |
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(3,053 |
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(8,179 |
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Research and development |
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(9,010 |
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(13,204 |
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(18,483 |
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(23,758 |
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Selling, general and administrative |
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(4,106 |
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(4,553 |
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(8,025 |
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(8,663 |
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Total |
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(14,320 |
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(21,456 |
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(29,561 |
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(40,600 |
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Profit (loss) from operations |
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(9,585 |
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(14,007 |
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(19,728 |
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(23,526 |
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Interest income net |
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488 |
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437 |
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939 |
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894 |
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Foreign exchange gain (loss) |
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(282 |
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(64 |
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(399 |
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(82 |
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Other income (loss) |
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(80 |
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33 |
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93 |
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38 |
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Income (loss) before income taxes |
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(9,459 |
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(13,601 |
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(19,095 |
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(22,676 |
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Income tax benefit (expense) |
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(9 |
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(32 |
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(34 |
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(18 |
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Net income (loss) |
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($9,468 |
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($13,633 |
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($19,129 |
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($22,694 |
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Earnings (loss) per share |
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Basic earnings (loss) per ordinary share |
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($0.40 |
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($0.57 |
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($0.80 |
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($0.95 |
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Diluted earnings (loss) per share |
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($0.40 |
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($0.57 |
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($0.80 |
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($0.95 |
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Weighted average number of shares outstanding (in thousands) : |
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Basic |
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23,768 |
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24,005 |
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23,768 |
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24,005 |
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Diluted |
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23,768 |
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24,005 |
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23,768 |
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24,005 |
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