COREG CR™ Launch; and Strong Sales of Product to GSK
Lyon, France, May 7, 2007 Flamel Technologies (NASDAQ:FLML) today announced its financial results for the first quarter of 2007.
Flamel's revenues during the quarter included the first royalties received from
GlaxoSmithKline (NYSE: GSK) on sales of COREG CR, which was launched on March 22nd.
For the first quarter, Flamel reported total revenues of $9.6 million versus $5.1 million
in the year-ago period. Product sales and services, consisting of COREG CR microparticle shipments to GSK, totaled $5.4 million.
Flamel's 2007 first quarter license and research revenues of $3.1 million included a $1 million milestone payment received from GSK;
license and research revenues in the year-ago period were $4.9 million and included $2 million in milestones from GSK.
Other revenues of $1.1 million increased from $0.2 million in the year-ago quarter and included royalties on the sale of COREG CR.
Operational expenses were $19.1 million, versus $15.2 million in the year-ago quarter.
Costs of goods and services sold were $4.5 million and comprised sales of COREG CR microparticles, as compared to $1.8 million in the first quarter
of 2006. Costs and expenses of Flamel's research and development were $10.6 million, compared to $9.5 million in the year-ago quarter.
SG&A expenses during the quarter were $4.1 million versus $3.9 million in the year-ago quarter.
Net loss for the quarter was ($9.1) million, compared to net loss of ($9.7) million in the first quarter of 2006.
Net loss per share (basic) for the first quarter of 2006 was ($0.38), compared to net loss per share (basic)
in the year-ago period of ($0.41). Cash and marketable securities at the end of the first quarter totaled $52.7 million,
reflecting the strong financial position of the Company.
Stephen H. Willard, Flamel's Chief Executive Officer, stated,
"We are pleased with the early success of the COREG CR launch. Feedback from the cardiological community has been very positive.
Physicians understand that the once-daily formulation of COREG CR offers key advantages to patients. It is well established that
once-daily medications lead to greater patient compliance; non-compliance is one of the leading causes of hospitalization
in heart failure patients. COREG CR delivers substantially the same peak and trough levels of carvedilol as the twice-a-day drug,
taken as directed, but with a smoother release profile. Moreover, COREG CR has been observed to result in 24% fewer adverse events than
immediate release Coreg in a crossover study conducted in hypertension patients. The success of COREG CR is generating positive interest
in the Micropump platform from potential partners and interest in the Medusa® platform has also been renewed. We look forward to further
positive developments with both platforms during 2007."
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 7, 2007. 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, 2006. FLAMEL
TECHNOLOGIES S.A. Licence and research revenue
$4,851 Product sales and services
19 Other revenues 228 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
The dial-in number (for investors in the U.S. and Canada) is 800-374-1498.
The conference ID number is 7441635.
International investors are invited to dial (1) 706-634-7261.
CONSOLIDATED STATEMENT OF OPERATIONS
(Amounts in thousands, except per share data)
Three
months ended
Mar
31 2006 (restated)
Mar
31 2007
Revenues
$3,124
5,400
1,101
Total
revenue
5,098
9,625
Costs and expenses
(1,849)
(4,480)
(9,473)
(10,554)
(3,919)
(4,110)
Total
costs and expenses
(15,241)
(19,144)
Profit (Loss) from operations
(10,143)
(9,519)
451
457
(117)
(18)
173
5
Income (Loss) before income
taxes
(9,636)
(9,075)
(25)
14
Net income (Loss)
($9,661)
($9,061)
Earnings (loss) per share
($0.41)
($0.41)
($0.38)
($0.38)
Weighted average number of
ordinary shares outstanding
23,737
23,737
23,991
23,991