Flamel Technologies (NASDAQ: FLML) today announced its financial
results for the first quarter of 2012.
Highlights for the quarter and subsequent time include:
- Total revenues of $7.3 million versus
total revenues of $6.8 million in the year-ago period
- Continuing to maintain a strong balance
sheet with $21.3 million of cash and marketable securities as of
March 31st, 2012
- Announcing the acquisition of Éclat
Pharmaceuticals, and moving forward with the integration of this
strategic initiative
- Remaining on track to file the
Company’s first New Drug Application (NDA) with the U.S. Food and
Drug Administration (FDA) in 2012
Flamel’s First Quarter
Results
Flamel reported total revenues for the first quarter 2012 of
$7.3 million versus total revenues of $6.8 million in the year-ago
period. The growth was driven by increased production of Coreg CR
microparticles. License and research revenues were $2.1 million
during the first quarter of 2012, versus $3.2 million in the first
quarter of 2011. Product sales and services during the first
quarter of 2012 were $3.4 million versus $1.6 million during the
year-ago quarter. Other revenues, consisting primarily of royalty
income from GSK on the sales of Coreg CR, were $1.9 million, a
slight decrease compared to the first quarter of 2011.
Total costs and expenses during the first quarter of 2012
increased to $12.1 million versus $11.7 million in the year-ago
period. Costs of goods and services sold for the first quarter of
2012 were $1.3 million, a slight decrease from $1.4 million in the
first quarter of 2011. Research and development costs in the first
quarter of 2012 totaled $5.7 million versus $7.8 million in the
year-ago period. This decrease is due to timing year on year of our
clinical and pre-clinical program. Selling, general, and
administrative costs were $5.1 million in the first quarter of 2012
versus $2.5 million in the first quarter of 2011. The costs
associated with the acquisition of Éclat Pharmaceuticals amounted
to $0.7 million, and we have incurred severance costs totaling $1.4
million.
Net loss for the first quarter of 2012 was $4.7 million versus a
net loss of $4.9million in the year-ago period. Net loss per share
(basic and diluted) was $0.19 versus a net loss per share (basic
and diluted) of $0.20 in the first quarter of 2011. The financial
results for the first quarter 2012 are not consolidated to include
the activity of Éclat Pharmaceuticals for the period from March 13,
2012, date of acquisition, to March 31, 2012.
During the quarter the Company acquired Éclat Pharmaceuticals, a
specialty pharmaceutical company focused on developing and
commercializing niche brands and generic products. Flamel has
continued to move forward with the integration of this strategic
initiative. These efforts include a company-wide portfolio review
and management transition.
Mike Anderson, Flamel’s chief executive officer, stated, “While
I have only been on board for a short period of time, I have been
very impressed with the quality and utility of the Flamel drug
delivery technology and continue to see new opportunities for the
combined company. I am also extremely excited about working with a
highly motivated and competent team here at Flamel and I remain
focused on delivering shareholder value as we build a sustainable,
vertically integrated specialty pharmaceutical company.”
Mr. Anderson continued, “We expect to use Flamel’s first in
class technology to build our own product portfolio in addition to
our traditional partnership model.”
A conference call to discuss these results is scheduled for 8:30
AM Eastern Daylight Time on Monday, May 7, 2012. A question and
answer period is scheduled to follow management’s prepared remarks.
The dial in number is +1-888-389-5997. The participant passcode is
3324983. The conference call webcast may be accessed at
www.flamel.com. A replay of the call will be available for 14 days
within a few hours after the call ends. Investors may listen to the
replay of the call by dialing +1-888-203-1112 (domestic) or
+1-719-457-0820 (international), with the passcode 3324983. A
replay of the webcast will also be archived on Flamel’s website for
90 days following the call.
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). Flamel recently acquired Éclat
Pharmaceuticals, a St. Louis, Missouri-based specialty
pharmaceutical company focused on developing and commercializing
niche brands and generic products. 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 Drug Master File
(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 from 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 also has
developed 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, the expected timing of the filing of our first
New Drug Application (NDA) with the FDA may be delayed, the
identified opportunities will not result in shorter-term, high
value results, 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 we may not be successful in identifying
and pursuing opportunities to develop our own product portfolio
using Flamel’s technology, and the risks associated with our
reliance on outside parties and key strategic alliances. These and
other risks are described more fully in Flamel's Annual Report on
Form 20-F for the year ended December 31, 2011 that has been filed
with the Securities and Exchange Commission (SEC). 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 March 31,
2011 2012 Revenue:
License and research revenue $ 3,214 $ 2,110 Product sales and
services 1,624 3,350 Other revenues 1,926
1,872 Total revenue 6,764 7,332
Costs and expenses: Cost of goods and services sold (1,371 ) (1,290
) Research and development (7,758 ) (5,706 ) Selling, general and
administrative (2,526 ) (5,057 ) Total (11,655
) (12,053 ) Profit (loss) from operations (4,891 )
(4,721 ) Interest income net 128 167 Foreign exchange gain
(loss) (240 ) (133 ) Other income (loss) 99 67 Income
(loss) before income taxes (4,904 ) (4,620 ) Income tax benefit
(expense) (23 ) (42 ) Net income (loss)
($4,927 ) ($4,662 ) Earnings (loss) per share
Basic earnings (loss) per ordinary share ($0.20 ) ($0.19 ) Diluted
earnings (loss) per share ($0.20 ) ($0.19 ) Weighted average
number of shares outstanding (in thousands) : Basic 24,646
25,012 Diluted 24,646 25,012
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