Full Press Release Details
Flamel Technologies Announces Third Quarter 2009 Results; Additional
New Projects; Cash Increases from $45.1 to $48.8 million
LYON, France November 16, 2009 Flamel Technologies (Nasdaq:FLML) today announced its financial
results for the third quarter of 2009. Highlights in the third quarter included:
| Significant technical and preclinical success in moving forward with our existing projects. | |||
| the signing of two further projects, one for Medusa for potentially multiple molecules, and the other for a Micropump formulation; and | |||
| an increase in the Company s cash and marketable securities from $45.1 million at the end of the first quarter to $48.8 MM. |
Stephen H. Willard, Flamel s chief executive officer, commented, In addition to our continued
success in attracting new projects and new partners, we are reaching a stage where many of our
existing projects are generating positive results. This is important as they will create the
opportunities to move these formulations forward through the regulatory pipeline.
This success is seen not only with delivery of proteins and peptides, but also with the expansion
into a variety of other types of therapeutic agents. We are demonstrating the ability to show in
vivo success with therapies other than subcutaneous injection, as most recently demonstrated in our
recent agreement with Pfizer regarding intravenous delivery using our Medusa technology.
Flamel is currently working on multiple projects, including those with GSK, Merck Serono, Pfizer,
and Baxter. We are diversified across both new and existing molecules, in a variety of therapeutic
areas. While we will continue to seek new partners and new applications, I expect the focus
increasingly to shift to the success and ramp-up of some of our most promising existing programs.
Flamel reported total revenues in the third quarter 2009 of $9.9 million, up from $9.1 million in
the year-ago period. License and research revenues grew to $4.7 million versus $3.1 million in the
third quarter of 2008. Product sales and services totaled $2.7 million during the quarter versus
$3.0 million in the third quarter, 2008. Other revenues during the third quarter of 2009,
including royalties on the sale of Coreg CR , were $2.5 million versus $3.0 million in the year-ago
Costs and expenses during the third quarter of 2009 were $(15.0) million versus $(13.8) million in
the year-ago period. Costs of goods and services sold in the quarter remained constant at $(2.6)
million for the third quarter of both 2008 and 2009. Research and
development expenses were $(9.3) million versus $(8.2) million in the third quarter of 2008. SG A
increased to $(3.1) million from $(2.9) million in the year-ago period.
Net loss in the third quarter of 2009 was $(3.4) million, compared to a net loss of $(2.3) million
in the third quarter of 2008. Net loss per share (basic) for the third quarter of 2009 was
($0.14), compared to a net loss per share (basic) in the year-ago period of ($0.10).
Cash and marketable securities at the end of the third quarter totaled $48.8 million versus $45.1
million at the end of the second quarter, 2009. This marked the fourth consecutive quarter that
the Company increased its cash and marketable securities position.
For the nine months of 2009, Flamel reported total revenues of $31.5 million versus $29.2 million
in the first nine months of 2008. License and research revenues during the period were $16.2
million versus $9.8 million in the year-ago period. Product sales and services during the first
nine months of 2009 were $7.6 million versus $10.9 million in the first nine months of 2008. Other
revenues during the first nine months of 2009 were $7.8 million versus $8.4 million in the year-ago
During the first nine months of 2009, total costs and expenses declined to $(42.2) million, from
$(44.4) million in the year-ago period. Costs of goods and services sold in the first nine months
of 2009 totaled $(6.5) million versus $(7.3) million in the year-ago period. Research and
development expenses during the first nine months of 2009 were $(26.3) million versus $(26.5)
million during the year-ago period. SG A for the first nine months of 2009 amounted to $(9.4)
million versus $(10.7) million in the year-ago period.
Net loss in the first nine months of 2009 was $(5.7) million, compared to a net loss of $(9.4)
million in the first nine months of last year. Net loss per share (basic) for the first nine
months of 2009 was $(0.24), compared to net loss per share (basic) in the year-ago period of
A conference call to discuss earnings is scheduled for 8:30 AM EST November 16, 2009. The dial-in
number (for investors in the U.S. and Canada) is 1-800-860-2442; the conference ID number is
435349. International investors are invited to dial 1 412-858-4600.
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 proteins, peptides, as well as other large and small molecules.
Charles Marlio, Director of Strategic Planning and Investor Relations
Tel: (33) (0)4-7278-3434
Fax: (33) (0)4-7278-3435
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. These and other risks are described more fully in Flamel s Annual Report on the
Securities and Exchange Commission Form 20-F for the year ended December 31, 2008.
Financial Statements (Unaudited)
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS (UNAUDITED)
(Amounts in thousands of dollars except share data)
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2008 | 2009 | 2008 | 2009 | |||||||||||||
| Revenue: | ||||||||||||||||
| License and research revenue | $ | 3,140 | $ | 4,726 | $ | 9,841 | $ | 16,156 | ||||||||
| Product sales and services | 3,023 | 2,651 | 10,918 | 7,602 | ||||||||||||
| Other revenues | 2,972 | 2,521 | 8,394 | 7,769 | ||||||||||||
| Total revenue | 9,135 | 9,898 | 29,153 | 31,527 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of goods and services sold | (2,613 | ) | (2,567 | ) | (7,263 | ) | (6,508 | ) | ||||||||
| Research and development | (8,239 | ) | (9,305 | ) | (26,476 | ) | (26,288 | ) | ||||||||
| Selling, general and administrative | (2,899 | ) | (3,138 | ) | (10,659 | ) | (9,371 | ) | ||||||||
| Total | (13,751 | ) | (15,010 | ) | (44,398 | ) | (42,167 | ) | ||||||||
| Loss from operations | (4,616 | ) | (5,112 | ) | (15,245 | ) | (10,640 | ) | ||||||||
| Interest income net | 377 | 92 | 1,127 | 349 | ||||||||||||
| Foreign gain (loss) | 220 | (140 | ) | 76 | (288 | ) | ||||||||||
| Other income | 58 | 4 | 159 | 13 | ||||||||||||
| Loss before income taxes | (3,961 | ) | (5,156 | ) | (13,883 | ) | (10,566 | ) | ||||||||
| Income tax benefit | 1,657 | 1,774 | 4,525 | 4,824 | ||||||||||||
| Net loss | $ | (2,304 | ) | $ | (3,382 | ) | $ | (9,358 | ) | $ | (5,742 | ) | ||||
| Loss per share | ||||||||||||||||
| Basic loss per ordinary share | $ | (0.10 | ) | $ | (0.14 | ) | $ | (0.39 | ) | $ | (0.24 | ) | ||||
| Diluted loss per share | $ | (0.10 | ) | $ | (0.14 | ) | $ | (0.39 | ) | $ | (0.24 | ) | ||||
| Weighted average number of shares outstanding (in thousands) : | ||||||||||||||||
| Basic | 24,077 | 24,225 | 24,066 | 24,217 | ||||||||||||
| Diluted | 24,077 | 24,225 | 24,066 | 24,217 |