Flamel Technologies (NASDAQ: FLML) today announced its financial
results for the fourth quarter of 2012 and full year 2012. The year
2012 marks the transition of Flamel from a stand-alone drug
delivery company to a specialty pharmaceutical company with
outstanding drug delivery capabilities. Highlights from the quarter
and subsequent period include:
- Management continues to advance internal pipeline and pursue
external business development opportunities,
- Flamel had $9.2 million of cash and marketable securities as of
December 31, 2012, prior to the debt financing, and
- Receipt of $14.5 million of net proceeds on February 4, 2013
from the previously announced $15 million debt financing with two
funds managed by Deerfield Management, the Company's largest
shareholder.
In March 2012 Flamel acquired Éclat Pharmaceuticals, LLC
(Éclat), which provided both marketing capabilities and a mature
pipeline of short term product opportunities. The company has
continued the development of those products and expects to launch
the first of them in the summer of 2013, providing there are no
unanticipated regulatory or other delays.
"Our progress in developing products at Éclat and additional
technology-driven products from Flamel's proprietary platform of
technologies has continued at a rapid pace and we are excited about
the expected approval and launch of our first product, as well as
the expected filing of additional marketing applications in 2013,"
said Mike Anderson, Chief Executive Officer of Flamel. "In
addition, the recent financing will serve two important purposes.
First, it allows us to continue investing aggressively in our
R&D pipeline; second, it also provides the means to market
effectively our first product, after its expected approval this
year."
Mr. Anderson continued, "We believe we have evolved the company
into an organization that now has three distinctive ways to create
revenue: commercializing the Éclat projects in the shorter term,
pursuing our self-funded internal projects in the mid-term, and
continuing to seek meaningful partnerships with other companies to
supplement the other initiatives."
"From an operating standpoint, management continues to exercise
cost discipline," he added, as fourth quarter 2012 operating
expenses, excluding non-cash elements, declined by $0.3 million
compared to the fourth quarter of 2011, despite absorbing
additional operating expenses from Éclat since March 2012.
Flamel's Fourth Quarter Results
Flamel reported total revenues during the fourth quarter of 2012
of $7.3 million versus $8.6 million in the fourth quarter of 2011.
The decrease was primarily driven by lower product sales and
services of $2.2 million in the fourth quarter of 2012 compared to
$4.2 million in the prior year quarter, as the fourth quarter of
2011 included the non-recurring revenues from the signing of a new
supply contract with Glaxo SmithKline ("GSK") for purchases of
Coreg CR®'s microparticles. License and research revenues grew to
$3.5 million during the fourth quarter of 2012 compared to $2.2
million in the prior year quarter, reflecting the recognition of
the remaining up-front monies received from Merck Serono,
subsequent to termination of the license agreement in October 2012.
Other revenues, consisting primarily of royalty income from GSK on
the sales of Coreg CR, declined to $1.7 million in the fourth
quarter of 2012 versus $2.2 million in the prior year quarter.
Total costs and expenses during the fourth quarter of 2012
decreased to $1.2 million versus $10.9 million in the prior year
period.
The total costs and expenses for the fourth quarter of 2012
included two major non-cash line items. The terms of acquisition of
Éclat Pharmaceuticals in March 2012 included the issuance of a $12
million note, whose repayment is tied to the approval and net sales
of certain Éclat products, 3.3 million warrants and earn-out
payments based on the gross profit achieved on the Éclat products.
These commitments are revalued and reassessed at each balance sheet
date based on information and data available at that time,
including financial projections related to the potential of the
Éclat products, as well as the share price and interest rate in so
far as they influence the value of the warrants. A favorable $16.5
million adjustment was realized in the fourth quarter 2012 from the
updated fair-value measurement of these liabilities. In addition,
Flamel took a $7.2 million charge to reflect the impairment of
R&D assets, mainly reflecting changes in market opportunities
for one of the acquired pipeline products. Excluding these
adjustments, operating expenses in the fourth quarter of 2012
decreased to $10.6 million compared to $10.9 million in the prior
year period.
Costs of goods and services sold for the fourth quarter of 2012
were $1.5 million compared to $1.9 million in the fourth quarter of
2011. Research and development costs in the fourth quarter of 2012
totaled $6.1 million versus $5.9 million in the prior year period.
This modest increase in R&D expense was primarily due to $0.7
million in Éclat-related expenses not present during the prior year
period. Selling, general and administrative costs were $3.0 million
in the fourth quarter of 2012 versus $3.2 million in the fourth
quarter of 2011, primarily resulting from cost-saving measures,
despite Éclat-related expenses of $0.6 million incurred in the
fourth quarter of 2012 not present during the prior year
period.
Total interest expense of $1.6 million for the fourth quarter of
2012 includes $1.7 million of non-cash expense related to debt used
to fund the Éclat acquisition, partially offset by interest earned
on our cash balance. In the fourth quarter of 2011, the Company had
interest income of $0.1 million.
Net income for the fourth quarter of 2012 was $9.1 million
versus a net loss of $2.1 million in the year-ago period. Earnings
per share (both basic and diluted) was $0.36 in the fourth quarter
of 2012 versus loss per share (basic and diluted) of $0.08 in the
fourth quarter of 2011. Net loss and loss per share (basic and
diluted) for the fourth quarter of 2012, excluding the impact of
the re-measurement of the fair value of acquisition liabilities,
the impairment of R&D assets and the impact of deferred taxes,
was $3.6 million and $0.14, respectively.
A conference call to discuss these results and other updates is
scheduled for 8:30 AM Eastern Standard Time on
Thursday, February 28, 2013. A question and answer period will
follow management's prepared remarks. To participate in the
conference call, investors are invited to dial 888-417-8533 (U.S.)
or 719-325-2361 (international). The conference ID number is
6788004. 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 888-203-1112 (U.S.) or 719-457-0820
(international), with the passcode 6788004. 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's (NASDAQ: FLML) business model is to blend
high-value internally developed products with its leading drug
delivery capabilities. The Company has a proprietary pipeline of
niche specialty pharmaceutical products, while its drug delivery
platforms are focused on the goal of developing safer, more
efficacious formulations of drugs to address unmet medical needs.
Its partnered pipeline includes biological and chemical drugs
formulated with its Medusa® and Micropump® (and its applications to
the development of liquid formulations, i.e. LiquiTime™ and of
abuse-deterrent formulations Trigger Lock™) proprietary drug
delivery platforms. Several Medusa-based products have been
successfully tested in clinical trials. The Company has developed
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). The Company is headquartered in Lyon, France and has
operations in St. Louis, Missouri, USA, and manufacturing
facilities in Pessac, France. Additional information may be found
at www.flamel.com.
This release 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," "may," 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 may not
be successfully integrated or that certain payment acceleration
events may be triggered; the new hospital-based product under FDA
review may not be approved or such approval may be delayed; the
reacquisition of the exclusive rights to develop and commercialize
IFN-β XL worldwide and identification of an alternative strategic
partner for the program may not be successful; the identified
opportunities will not result in shorter-term, high value results;
clinical trial results may not be positive or our partners may
decide not to move forward; management transition 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 Twelve months ended
December 31, December 31,
-------------------- --------------------
2011 2012 2011 2012
--------- --------- --------- ---------
Revenue:
License and research revenue $ 2,170 $ 3,450 $ 10,566 $ 9,324
Product sales and services 4,242 2,163 13,395 9,657
Other revenues 2,237 1,697 8,639 7,120
--------- --------- --------- ---------
Total revenue 8,649 7,310 32,600 26,101
--------- --------- --------- ---------
Costs and expenses:
Cost of goods and services
sold (1,850) (1,495) (6,284) (5,860)
Research and development (5,910) (6,162) (25,089) (26,115)
Selling, general and
administrative (3,166) (2,950) (10,810) (14,153)
Remeasurement of acquisition
liabilities - 16,538 - 23,710
Impairment of assets - (7,170) - (7,170)
--------- --------- --------- ---------
Total (10,926) (1,239) (42,183) (29,588)
--------- --------- --------- ---------
Profit (loss) from operations (2,277) 6,071 (9,583) (3,487)
Interest income (loss) net (1) 122 (1,569) 594 (4,365)
Foreign exchange gain (loss) 118 (108) 273 (180)
Other income (loss) 5 11 134 102
--------- --------- --------- ---------
Income (loss) before income
taxes (2,032) 4,405 (8,582) (7,930)
Income tax benefit (expense) (59) 4,696 (192) 4,702
--------- --------- --------- ---------
Net Income (loss) $ (2,091) $ 9,101 $ (8,774) $ (3,228)
========= ========= ========= =========
Earnings (loss) per share
Basic earnings (loss) per
ordinary share $ (0.08) $ 0.36 $ (0.36) $ (0.13)
Diluted earnings (loss) per
share $ (0.08) $ 0.36 $ (0.36) $ (0.13)
Weighted average number of shares
outstanding (in thousands) :
Basic 24,737 25,213 24,669 25,086
Diluted 24,737 25,314 24,669 25,086
(1) In 2012, includes impact of passage of time on valuation of acquisition
liabilities.
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