Full Press Release Details
Technologies Announces Third Quarter Results; Achievement of Second Milestone in
Fourth Quarter with Merck Serono
LYON, France-November 4,
2010--Flamel Technologies (Nasdaq:FLML) today announced its financial
results for the third quarter of 2010.
Company also announced today that it has achieved a further milestone in its
development program with Merck Serono, a division of Merck KGaA, Darmstadt,
Germany, for an extended release formulation of interferon-beta
1-a. According to the terms of the original development agreement
negotiated in 2007, Flamel will receive 1 million from Merck
recent highlights in the third quarter include:
H. Willard, Flamel's chief executive officer, commented, "Our achievements with
the Merck Serono project are the product of over two years of work and mark an
important point in the Company's development of the Medusa
platform. These two most recent milestones are further steps in the
advancement of this program, which we believe demonstrates the continued growth
of Flamel and our Medusa Platform. We are pursuing multiple projects with the
Medusa platform which we believe will progress at a fast pace in the year
Willard continued, "We are increasingly discussing opportunities to leverage our
expertise in the creation of improved formulations of already-marketed molecules
with interested parties, including the creation of bio-better
opportunities. We believe that the Company is uniquely positioned for
this opportunity, as the Medusa platform has been shown to deliver improved
efficacy and safety without chemical modification of the molecule being
reported total revenues in the third quarter 2010 of $8.0 million, versus $9.9
million in the year-ago period. License and research revenues were
$4.1 million versus $4.7 million in the third quarter of
2009. Product sales and services totaled $1.8 million during the
quarter versus $2.7 million in the third quarter
2009. Other revenues during the third quarter of 2010,
composed primarily of royalties on the sale of Coreg CR , were $2.1 million
versus $2.5 million in the year-ago period.
expenses during the third quarter of 2010 were $(11.2) million versus $(13.2)
million in the year-ago period. Costs of goods and services sold in
the quarter were $(1.5) million versus $(2.6) million in the year-ago
period. Research and development expenses were $(6.7) million versus
$(7.5) million in the third quarter of 2009. SG&A declined to
$(2.9) million from $(3.1) million in the year-ago period.
in the third quarter of 2010 was $(3.3) million, compared to a net loss of
$(3.4) million in the third quarter of 2009. Net loss per share
(basic) for the third quarter of 2010 was ($0.14), as it was in third quarter of
marketable securities at the end of the third quarter totaled $32.1 million
versus $33.7 million at the end of the second quarter of 2010.
first nine months of 2010, Flamel reported total revenues of $23.6 million
versus $31.5 million in the first nine months of 2009. License and research
revenues during the period were $10.9 million versus $16.2 million in the
year-ago period. Product sales and services during the first nine
months of 2010 were $6.0 million versus $7.6 million in the first nine months of
2009. Other revenues during the first nine months of 2010 were $6.8
million versus $7.8 million in the year-ago period.
the first nine months of 2010, total costs and expenses declined to $(35.5)
million, from $(37.3) million in the year-ago period. Costs of goods
and services sold in the first nine months of 2010 totaled $(5.0) million versus
$(6.5) million in the year-ago period. Research and development
expenses during the first nine months of 2010 were $(21.8) million versus
$(21.5) million during the year-ago period. SG&A for the first
nine months of 2010 amounted to $(8.7) million versus $(9.4) million in the
in the first nine months of 2010 was $(11.7) million, compared to a net loss of
$(5.7) million in the first nine months of last year. Net loss per
share (basic) for the first nine months of 2010 was $(0.48), compared to net
loss per share (basic) in the year-ago period of $(0.24).
conference call to discuss earnings is scheduled for 8:30 AM EDT on November 5,
2010. The dial-in number (for investors in the U.S. and Canada) is
(1) 877-719-9799; the conference ID number is 3279524. International
investors are invited to dial (1) 719-325-4857.
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.
Marlio, Director of Strategic Planning and Investor Relations
document contains forward-looking statements within the meaning of the U.S.
federal securities laws, including statements regarding the status of various
research and development projects and technology platforms. These
statements are identified by terms such as "anticipate," "believe," "could,"
"estimate," "expect," "intend," "may," "should," "plan," "predict," "project,"
"will," "continue" and other similar expressions and speak as of the date they
are made. 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. We undertake no obligation to update these forward-looking statements
as a result of new information, future events or otherwise, and you should not
place undue reliance on such statements. 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, 2009.
Financial Statements
CONSOLIDATED STATEMENT OF OPERATIONS (UNAUDITED)
in thousands of dollars except share data)
| Three months ended September 30, | Nine months ended September 30, | |||||||||||||||
| 2009 | 2010 | 2009 | 2010 | |||||||||||||
| Revenue: | ||||||||||||||||
| License and research revenue | $ | 4,726 | $ | 4,119 | $ | 16,156 | $ | 10,865 | ||||||||
| Product sales and services | 2,651 | 1,805 | 7,602 | 5,970 | ||||||||||||
| Other revenues | 2,521 | 2,117 | 7,769 | 6,808 | ||||||||||||
| Total revenue | 9,898 | 8,041 | 31,527 | 23,643 | ||||||||||||
| Costs and expenses: | ||||||||||||||||
| Cost of goods and services sold | (2,567 | ) | (1,535 | ) | (6,508 | ) | (5,045 | ) | ||||||||
| Research and development | (7,531 | ) | (6,702 | ) | (21,464 | ) | (21,824 | ) | ||||||||
| Selling, general and administrative | (3,138 | ) | (2,931 | ) | (9,371 | ) | (8,659 | ) | ||||||||
| Total | (13,236 | ) | (11,168 | ) | (37,343 | ) | (35,528 | ) | ||||||||
| Loss from operations | (3,338 | ) | (3,127 | ) | (5,816 | ) | (11,885 | ) | ||||||||
| Interest income net | 92 | 109 | 349 | 326 | ||||||||||||
| Foreign exchange gain (loss) | (140 | ) | (302 | ) | (288 | ) | (87 | ) | ||||||||
| Other income | 4 | 5 | 13 | 93 | ||||||||||||
| Loss before income taxes | (3,382 | ) | (3,315 | ) | (5,742 | ) | (11,553 | ) | ||||||||
| Income tax benefit (expense)* | - | (24 | ) | - | (100 | ) | ||||||||||
| Net loss | $ | (3,382 | ) | $ | (3,339 | ) | $ | (5,742 | ) | $ | (11,653 | ) | ||||
| Loss per share | ||||||||||||||||
| Basic loss per ordinary share | $ | (0.14 | ) | $ | (0.14 | ) | $ | (0.24 | ) | $ | (0.48 | ) | ||||
| Diluted loss per share | $ | (0.14 | ) | $ | (0.14 | ) | $ | (0.24 | ) | $ | (0.48 | ) | ||||
| Weighted average number of shares outstanding (in thousands) : | ||||||||||||||||
| Basic | 24,225 | 24,423 | 24,217 | 24,391 | ||||||||||||
| Diluted | 24,225 | 24,423 | 24,217 | 24,391 | ||||||||||||
| * Research tax credit reclassified in operational expenses for 2009 |