Lyon, France, March 7, 2006 Flamel Technologies (NASDAQ:FLML) today announced its financial results for the fourth quarter and year ended December 31, 2005.
Flamel's Fourth Quarter ResultsFlamel reported a net loss of ($6.4 million) for the fourth quarter of 2005 versus net income of $7.9 million in the year-ago period. Net loss per share (basic) was ($0.28) versus $0.37 in the fourth quarter of 2004. Diluted earnings per share in the fourth quarter of 2004 equaled $0.34.
Total revenues for the fourth quarter 2005 were $6.3 million, versus $18.7 million in the year-ago period. License and research revenue totaled $5.7 million during the quarter, compared to $17.8 million in the same period in 2004. Both total revenues and license and research revenues in the fourth quarter of 2004 included recognition of $12.6 million from Bristol-Myers Squibb, amortizing an upfront payment from 2003. License and research revenue recognized during the fourth quarter 2005 primarily included revenues from GlaxoSmithKline. Product sales and services during the fourth quarter of 2005 were $0.3 million versus $0.8 million in the same period last year.
Costs and expenses during the quarter were $17.4 million, as compared to $13.7 million in the fourth quarter of 2004. In line with our efforts to control expenses, operational expenses decreased sequentially during the quarter to $13.1 million before a $4.3 million provision for costs, which resulted as a consequence of the departure of the Company's former Chairman and CEO and related parties. Operational expenses were $15.3 million in Q3 2005. For the calendar year 2005, Flamel reported that its operating revenue was $23.6 million, compared to $55.4 million in 2004. License and research revenue was $20.8 million in 2005, a decline from $50.9 million in 2004. License and research revenue in 2005 primarily included revenues from GlaxoSmithKline and TAP Pharmaceutical Products Inc. Product sales and services for the year 2005 were $1.8 million, compared to $3.8 million in the year-ago period.
Expenses in 2005 increased to $64.4 million ($60.1 million before the non-recurring costs mentioned above) from $46.6 million in 2004. The increase was largely in research and development expenses concerning the formulation of additional drugs using our technologies, particularly Interferon-alpha and Interleukin-2, as well as a new formulation of Basulin®.
The Company reported a net loss for the year 2005 of ($27.4 million), or ($1.19) per share, as compared with net income of $12.5 million in 2004, which equaled $0.58 per share (basic) and $0.53 (diluted).
In line with expectations, Flamel's cash and marketable securities at year-end 2005 was $83.7 million, compared to $105.4 million at the end of 2004. The decline in the value of cash and marketable securities would have been limited to $8 million had there been no changes in foreign exchange rates between the euro and the U.S. dollar. The Company's cash and marketable securities are typically held in euros, the currency in which the majority of the Company's expenses are incurred.
Michel Finance, chief financial officer of Flamel Technologies, noted: "We are pleased that our focus on prudent fiscal stewardship has allowed us to tightly manage our expenses. We have invested significant resources from our partner, GlaxoSmithKline, in our Pessac manufacturing facility and we expect it to be fully operational shortly. We begin 2006 with the financial resources we need to realize our plans to develop Flamel's extraordinary potential for growth."
Stephen H. Willard, Flamel's chief executive officer, said: "In the past six months, Flamel has completed a transformation that is essential to our future success. We have strengthened morale and retained all of our key scientists. We have renewed our business development efforts. We have successfully advanced our partnership with GlaxoSmithKline as most recently evidenced by the submission of the NDA for Coreg in December. We are well-positioned to execute on our remaining goals of creating new partnerships to leverage our two technology platforms: Micropump® and Medusa®."
About Flamel Technologies
Flamel Technologies is a drug delivery company with two intellectual property platforms: Micropump, for the controlled release of drugs best absorbed in the small intestine; and Medusa, for the controlled release of proteins and peptides injected subcutaneously. Both of these platforms offer advantages with respect to efficacy and the reduction of side-effects, in addition to the obvious benefits associated with more convenient dosing regimens. For detailed company information, including copies of this and other press releases, see Flamel's web site www.flamel.com.
A conference call to discuss these results is scheduled for 8:30 AM Eastern Time March 8, 2006. The dial-in number is 800-374-1498 (Conference ID 6135376). International callers are invited to dial-in (1) 706-634-7261.
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
17,794 50,893 Product sales and services
762 3,755 Other revenues 162 762 Cost of goods and services sold
(3,602) Research and development (35,359) 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
Flamel's 2005 Annual Results
CONSOLIDATED STATEMENT OF OPERATIONS
(Amounts in thousands, except per share data)
Three
months ended
Twelve
months ended
Dec
31 2004
Dec
31 2005
Dec
31 2004
Dec
31 2005
Revenues
5,684
20,825
349
1,757
228
1,016
Total
revenue
18,718
6,261
55,410
23,598
Costs and expenses
(973)
(525)
(2,525)
(10,913)
(9,719)
(47,301)
(1,813)
(7,108)
(7,614)
(14,541)
Total
costs and expenses
(13,699)
(17,352)
(46,575)
(64,367)
Profit / (Loss) from operations
5,019
(11,091)
8,835
(40,769)
165
389
607
3,603
(274)
165
(244)
500
(208)
(297)
100
5,003
Income (Loss) before income
taxes
4,702
(10,834)
9,298
(31,663)
3,224
4,386
3,201
4,286
Net income (Loss)
7,926
(6,448)
12,499
(27,377)
Earnings (loss) per share
$
0.37
($ 0.28)
$ 0.58
($1.19)
$
0.34
($ 0.28)
$ 0.53
($1.19)
Weighted average number of
ordinary shares outstanding
21,514
22,995
21,514
22,995
23,559
22.995
23,559
22,995