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. Flamel's 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 Company's 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 Company's ongoing strategy to control expenses.
Costs and expenses of Flamel's 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 Flamel's 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, Flamel's 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."
About Flamel Technologies
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 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.
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.
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, 2004. FLAMEL
TECHNOLOGIES S.A. Licence and research revenue
$7,449 Product sales and services
408 Other revenues 248 Cost of goods and services sold
Research and development Selling, general and administrative
Interest income net Foreign exchange gain (loss)
Other income (loss) Income tax benefit (expense)
Basic earnings (loss) per ordinary
share Diluted earnings (loss) per ordinary
share Basic Diluted
CONSOLIDATED STATEMENT OF OPERATIONS
(Amounts in thousands, except per share data)
Three
months ended
Mar
31 2005
Mar
31 2006
Revenues
$4,851
19
228
Total
revenue
8,105
5,098
Costs and expenses
(337)
(2,144)
(13,454)
(10,024)
(1,894)
(3,073)
Total
costs and expenses
(15,685)
(15,241)
Profit (Loss) from operations
(7,580)
(10,143)
2,310
451
381
(117)
5,267
173
Income (Loss) before income
taxes
378
(9,636)
(193)
(25)
Net income (Loss)
$185
($9,661)
Earnings (loss) per share
$
0.01
($ 0.41)
$
0.01
($ 0.41)
Weighted average number of
ordinary shares outstanding
21,548
23,737
23,200
23,737