e6vk
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 May 2006
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 the 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-
INFORMATION FILED WITH THIS REPORT
Document Index
|
99.1 |
|
Press Release dated May 3, 2006 |
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, thereunto duly authorized.
|
|
|
|
|
|
|
|
|
Flamel Technologies S.A. |
|
|
|
|
|
|
|
|
|
|
|
By:
|
|
/s/ Stephen Willard |
|
|
|
|
|
|
|
|
|
Dated:
May 16, 2006
|
|
Name:
|
|
Stephen Willard |
|
|
|
|
Title:
|
|
Chief Executive Officer |
|
|
3
exv99w1
Exhibit 99.1
For Immediate Release
Flamel Technologies Announces First Quarter Results
LYON, France May 3, 2006 Flamel Technologies (Nasdaq:FLML) today announced its financial
results for the first quarter of 2006.
Flamel showed significant progress during the first quarter in its partnership with GlaxoSmithKline
(GSK) as the FDA accepted the New Drug Application which was submitted for the new formulation of
Coreg® during the last quarter of 2005. Flamel is gearing up for production of this product in
advance of the anticipated launch later this year.
For the first quarter, Flamel reported total revenues of $5.1 million. Flamels 2006 first
quarter license and research revenues of $4.9 million included a $2 million milestone payment
received from GSK. Total revenues in the first quarter of 2005 amounted to $8.1 million, including
license and research revenues of $7.4 million. Revenues from product sales and services during
the quarter declined year-over-year from $0.4 million to $0.02 million as the Company eliminated
contract manufacturing activities in preparation for anticipated production pursuant to our supply
agreement with GSK.
Operational expenses were $15.2 million, versus $15.7 million in the year-ago quarter. The 2006
costs and expenses include $2.3 million of options-related expense in accordance with the Companys
first implementation of SFAS 123R; expenses before accounting for options would have totaled $12.9
million. This decrease in comparable year-over-year numbers is a result of the Companys ongoing
strategy to control expenses.
Costs and expenses of Flamels research and development were $10.0 million, compared to $13.5
million in the year-ago quarter. Before options-related expense, 2006 first quarter R&D costs
and expenses would have totaled $8.5 million. Flamel employed more than 250 employees over the
first three months of 2006, of whom approximately 60% were scientists involved in research and
development, a reflection of Flamels strong commitment to developing its current technologies
beyond existing projects and partnerships.
Costs of goods and services sold were $2.1 million, including $0.3 million in options-related
expense. These costs are linked with the expenses incurred by the Company for future supply to GSK
in anticipation of the projected launch later this year.
SG&A expense of $3.1 million included option-related expense of $0.5 million; 2005 first quarter
SG&A equaled $1.9 million.
Net loss for the quarter was ($9.7) million, compared to net income of $0.2 million in the first
quarter of 2005. Net loss per share (basic) for the first quarter of 2006 was ($0.41), compared to
net income per share (basic) in the year-ago period of $0.01. Fully diluted earnings per share for
the year-ago quarter were $0.01. Cash and marketable securities at the end of the first quarter
totaled $75.3 million, reflecting the strong financial position of the Company.
Stephen H. Willard, Flamels Chief Executive Officer, stated, We are pleased that the FDA accepted
the New Drug Application that our partner GSK submitted for this new formulation. The success of
our work with GSK is attracting favorable attention from a number of potential pharmaceutical
partners; we are pleased that our discussions with these companies are progressing well. Our goal
is to develop our existing technology through partnerships which fully cover the costs of our
current activity levels, such that the Coreg royalties can be used to strengthen the value of our
company.
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.
A conference call to discuss earnings is scheduled for 8:30 AM EDT May 4, 2006. The dial-in number
(for investors in the U.S. and Canada) is 800-374-1498; The conference ID number is 8474990 .
International investors are invited to dial (1) 706-634-7261.
Coreg® is a registered trademark of GlaxoSmithKline.
Contact:
|
|
|
|
|
Stephen H. Willard, Chief Executive Officer |
Tel: |
|
(1) 202-862-8400 |
Fax: |
|
(1) 202-862-3933 |
|
|
|
|
|
Michel Finance, Chief Financial Officer |
Tel: |
|
(011) (33) 4-7278- 3434 |
Fax: |
|
(011) (33) 4-7278-3435 |
Finance@flamel.com |
|
|
|
|
|
Charles Marlio, Director of Strategic Planning and Investor Relations |
FRANCE:
|
|
|
|
(011) 33-4-72-78-34-34 |
US
|
|
|
|
(1) (202) 862-8400 |
Fax:
|
|
|
|
202-862-3933 |
Marlio@flamel.com |
This document contains a number of matters, particularly as related to financial projections
and 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, 2004.
Schedule Attached
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
(Amounts in thousands of dollars except share data)
|
|
|
|
|
|
|
|
|
|
|
Three months ended March 31, |
|
|
|
2005 |
|
|
2006 |
|
Revenue: |
|
|
|
|
|
|
|
|
License and research revenue |
|
$ |
7,449 |
|
|
$ |
4,851 |
|
Product sales and services |
|
|
408 |
|
|
|
19 |
|
Other revenues |
|
|
248 |
|
|
|
228 |
|
|
|
|
|
|
|
|
Total revenue |
|
|
8,105 |
|
|
|
5,098 |
|
|
|
|
|
|
|
|
Costs and expenses: |
|
|
|
|
|
|
|
|
Cost of goods and services sold |
|
|
(337 |
) |
|
|
(2,144 |
) |
Research and development |
|
|
(13,454 |
) |
|
|
(10,024 |
) |
Selling, general and administrative |
|
|
(1,894 |
) |
|
|
(3,073 |
) |
|
|
|
|
|
|
|
Total |
|
|
(15,685 |
) |
|
|
(15,241 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Profit (loss) from operations |
|
|
(7,580 |
) |
|
|
(10,143 |
) |
|
|
|
|
|
|
|
|
|
Interest income net |
|
|
2,310 |
|
|
|
451 |
|
Foreign exchange gain (loss) |
|
|
381 |
|
|
|
(117 |
) |
Other income (loss) |
|
|
5,267 |
|
|
|
173 |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Income (loss) before income taxes |
|
|
378 |
|
|
|
(9,636 |
) |
Income tax benefit (expense) |
|
|
(193 |
) |
|
|
(25 |
) |
|
|
|
|
|
|
|
Net income (loss) |
|
$ |
185 |
|
|
|
($9,661 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Earnings (loss) per share |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic earnings (loss) per ordinary share |
|
$ |
0.01 |
|
|
|
($0.41 |
) |
Diluted earnings (loss) per share |
|
$ |
0.01 |
|
|
|
($0.41 |
) |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Weighted average number of shares outstanding (in thousands) : |
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Basic |
|
|
21,548 |
|
|
|
23,737 |
|
Diluted |
|
|
23,200 |
|
|
|
23,737 |
|