Flamel Technologies (NASDAQ: FLML) today announced its financial
results for the fourth quarter and year ended December 31,
2011.
Separately, the Company also announced today that it has agreed
to acquire Éclat Pharmaceuticals, a St. Louis, Missouri-based
special pharmaceutical company focused on developing and
commercializing niche brands and generic products. Éclat
Pharmaceuticals is a wholly owned subsidiary of an affiliate of
Deerfield Capital L.P., which together with its other affiliates is
our largest shareholder. Steve Willard, Flamel’s current chief
executive officer, has resigned as CEO, and Mike Anderson, Éclat’s
chief executive officer, has become chief executive officer of
Flamel Technologies. Mr. Willard will remain a director of Flamel
and an employee of a US subsidiary of Flamel. A press release
announcing these changes is available at www.flamel.com.
Fourth Quarter and Recent
Highlights:
- Inclusion in the Orange Book of
Flamel’s US Pat. No. 8,101,209 related to our Micropump
technology.
- A €1.3 MM payment resulting from a
multi-year supply agreement signed with GSK for the production of
Coreg CR® microparticles.
- Completion of the Phase I Clinical
study of long acting beta interferon 1a by Merck Serono, which
results we are analyzing and discussing with our partner.
- Interferon alpha results are largely
complete and Flamel has applied to present them at a major
scientific congress. Licensing discussions are currently ongoing
with multiple parties.
- Partnership with Pfizer
discontinued.
- Signed two new feasibility agreements:
one for LiquiTime and one for Trigger Lock.
Mr. Willard stated, “The issuance of our new Micropump patent
and its inclusion in the FDA Orange Book is, I believe, a very
significant event, in that it is a major expansion of our Micropump
technology intellectual property. The new patent covers the
delivery of microparticles with varying release profiles, such that
we can better match or improve the delivery of oral molecules.
Because it is used in Coreg CR, the grant of this patent may
strengthen the ability to defend Coreg CR in the future. It also
will be helpful in our efforts to expand significantly into
partnerships or other transactions for our Micropump platform,
including our patented long-acting stable liquid formulations
(i.e., LiquiTime).”
Mr. Willard continued, “We are approaching completion of our
Phase 2 clinical trial on Interferon alpha. We have a number of
other partnered projects in various clinical trials and we continue
working to execute on the initiatives we have discussed on our
recent public conference calls.”
Flamel’s Fourth Quarter
Results
Flamel reported total revenues for the fourth quarter 2011 of
$8.6 million versus total revenues of $13.5 million in the year-ago
period; total revenues in the fourth quarter of 2010 included a
milestone payment of €3 million from Merck Serono that resulted
from the commencement of a Phase 1 clinical trial on an
improved formulation of beta-interferon 1-a, as well as a separate
€1 million milestone that was triggered by certain technical
achievements. License and research revenues were $2.2 million
during the fourth quarter of 2011, versus $8.8 million in the
fourth quarter of 2010. Product sales and services during the
fourth quarter of 2011, related primarily to production of Coreg CR
microparticles, were $4.2 million versus $2.2 million during the
year-ago quarter. Other revenues, consisting primarily of royalty
income from GSK on the sales of Coreg CR, were $2.2 million as
compared to $2.4 million in the fourth quarter of 2010.
Total costs and expenses during the fourth quarter of 2011
declined to $10.9 million versus $11.4 million in the year-ago
period. Costs of goods and services sold for the fourth quarter
2011 were comparable with the prior year at $1.9 million. Research
and development costs in the fourth quarter of 2011 totaled $5.9
million versus $6.9 million in the year-ago period. Selling,
general, and administrative costs were $3.2 million in the fourth
quarter 2011 versus $2.7 million in the fourth quarter of 2010.
Net loss for the fourth quarter of 2011 was ($2.1 million)
versus net income of $2.7 million in the year-ago period. Net loss
per share (basic and diluted) was ($0.08) versus net income per
share (basic and diluted) of $0.11 in the fourth quarter of
2010.
Flamel’s 2011 Annual
Results
For the calendar year 2011, Flamel reported total revenues of
$32.6 million, compared to $37.1 million in 2010. License and
research revenue during 2011 was $10.6 million versus $19.7 million
in 2010. Product sales and services for the year 2011 increased to
$13.4 million, from $8.2 million in the year-ago period. Other
revenues, consisting primarily of royalty income from sales of
Coreg CR by GSK, totaled $8.6 million in 2011 versus $9.2 million
in 2010.
Total costs and expenses declined in 2011 to $42.2 million from
$46.9 million in 2010. Costs of goods and services sold declined as
well, to $6.3 million in 2011 versus $6.9 million in 2010. Research
& development expenses were $25.1 million versus $28.7 million
in 2010. SG&A in 2011 totaled $10.8 million versus $11.3
million in 2010.
The Company reported a net loss for the year 2011 of ($8.8
million) or ($0.36) per share versus a net loss in 2010 of ($9.0
million), or ($0.37) per share. Flamel finished 2011 with $24.5
million in cash and marketable securities.
The Company is also updating its legal proceeding disclosure,
noting that on March 6, 2012, the US District Court for the
Southern District of New York issued its opinion granting the lead
plaintiff’s motion for class certification in the pending Billhofer
v. Flamel Technologies, et al. securities litigation. The Company
intends to continue to defend itself vigorously in this matter.
A conference call to discuss these results as well as the
acquisition of Éclat Pharmaceuticals is scheduled for 8:30 AM Eastern Daylight Time Thursday, March 15,
2012. A question and answer period is scheduled to follow
management’s prepared remarks. The dial in number is 1-888-256-9132. The conference ID number is 4062934. The conference call webcast
may be accessed at www.flamel.com.
About Flamel Technologies. Flamel Technologies SA
(NASDAQ: FLML) is a leading drug delivery company focused on the
goal of developing safer, more efficacious formulations of drugs
that address unmet medical needs. Its product development pipeline
includes biological and chemical drugs formulated with the Medusa®
and Micropump® proprietary platforms. Several Medusa-based products
are at various clinical stages of development; Medusa’s lead
internal product candidate IFN-alpha XL (long-acting interferon
alpha-2b) is being evaluated a Phase 2a trial in HCV patients. The
Company has developed approved products and manufactures
Micropump-based microparticles under FDA-audited GMP guidelines.
Flamel Technologies has collaborations with a number of leading
pharmaceutical and biotechnology companies, including
GlaxoSmithKline (Coreg CR®, carvedilol phosphate) and Merck Serono
(long acting interferon beta 1a). Additional information can be
found at www.flamel.com.
About Medusa®. The Medusa® drug delivery platform
consists of proprietary hydrogels for the formulation and/or the
extended release of a broad range of biologics (including proteins,
antibodies, peptides and vaccines) and of small molecules
(injectable drugs). The hydrogel, which are easy and cost effective
to produce under EMA/FDA cGMP guidance, has been proven to be safe
and biodegradable: Flamel Technologies filed a DMF for Medusa with
the FDA on February 12, 2011 (assigned number 024634). Medusa
enables the controlled delivery from 1 day up to 14 days of
non-denatured or non-modified drugs that remain fully active (as
distinguished to protein engineering or chemical modification
approaches). It is used to develop biobetters with potentially
improved efficacy and reduced toxicity, as well as greater patient
convenience. Additional information can be found at
www.flamel.com/technology-platforms/medusa/.
About Micropump®. The Micropump® micro-encapsulation drug
delivery platform (oral drugs) is designed to increase the
absorption time of drugs, particularly for drugs only absorbed in
the small intestine. Micropump enables the achievement of precise
pharmacokinetics Micropump can be presented in various dosage forms
such as capsules, tablets, sachets or oral suspensions (LiquiTime®)
without modifying the release rate. Flamel develops also another
drug delivery technology for oral drugs, i.e. Trigger Lock™ for the
controlled release of narcotic and opioid analgesics while
deterring tampering (particles cannot be crushed to extract the
active). Additional information can be found at
www.flamel.com/technology-platforms/micropump/.
This document contains “forward-looking statements” within the
meaning of the Private Securities Litigation Reform Act of 1995,
including certain plans, expectations, goals and projections
regarding financial results, product developments and technology
platforms. All statements that are not clearly historical in nature
are forward-looking, and the words “anticipate,” “assume,”
“believe,” “expect,” “estimate,” “plan,” will,” and similar
expressions are generally intended to identify forward-looking
statements. All forward-looking statements involve risks,
uncertainties and contingencies, many of which are beyond our
control, that could cause actual results to differ materially from
those contemplated in such forward-looking statements. These risks
include risks that the acquisition of Éclat Pharmaceuticals will
not be successful, clinical trial results will not be positive or
that our partners may decide not to move forward, management
transition to a new chief executive officer may be disruptive or
not succeed as planned, products in the development stage may not
achieve scientific objectives or milestones or meet stringent
regulatory requirements, products in development may not achieve
market acceptance, competitive products and pricing may hinder our
commercial opportunities, 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, 2010. All forward-looking statements included in this
release are based on information available at the time of the
release. We undertake no obligation to update or alter our
forward-looking statements as a result of new information, future
events or otherwise.
Condensed Consolidated Statements of
Operations
(amounts in thousands, except per share
data)
Three months ended December 31, Twelve months
ended December 31, 2010 2011 2010
2011 Revenue: License and research revenue $8,839 $2,170
$19,704 $10,566 Product sales and services 2,210 4,242 8,180 13,395
Other revenues 2,402 2,237 9,210 8,639 Total revenue 13,451 8,649
37,094 32,600 Costs and expenses: Cost of goods and services sold
(1,869) (1,850) (6,914) (6,284) Research and development (6,863)
(5,910) (28,687) (25,089) Selling, general and administrative
(2,674) (3,166) (11,333) (10,810) Total (11,406) (10,926) (46,934)
(42,183) Profit (loss) from operations 2,045 (2,277) (9,840)
(9,583) Interest income net 114 122 440 594 Foreign exchange
gain (loss) 196 118 109 273 Other income (loss) 432 5 525 134
Income (loss) before income taxes 2,787
(2,032) (8,766) (8,582) Income tax expense (109) (59) (209) (192)
Net Income (loss) $2,678 ($2,091) ($8,975) ($8,774) Earnings
(loss) per share Basic earnings (loss) per ordinary share
$0.11 ($0.08) ($0.37) ($0.36) Diluted earnings (loss) per share
$0.11 ($0.08) ($0.37) ($0.36)
Weighted average number of shares
outstanding (in thousands):
Basic 24,472 24,737 24,411 24,669 Diluted 24,941 24,737
24,411 24,669
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