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Flamel Technologies Announces Fourth Quarter and Full Year 2012 Results Conference call with management to take place at 8:30 AM EST on

Key Takeaway: Technologies Announces Fourth Quarter and Full Year 2012 Results Conference call with management to take place at 8:30 AM EST on February 28, 2013 Lyon, France - February 28, 2013 - Flamel Technologies (NASDAQ: FLML) today announced its financial results for the fourth quarte

Full Press Release Details

Technologies Announces Fourth Quarter and Full Year 2012 Results
Conference call with management to
take place at 8:30 AM EST on February 28, 2013
Lyon, France - February 28,
2013 - 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:
In March 2012 Flamel acquired clat
Pharmaceuticals, LLC ( clat), 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 clat 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 clat
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
clat 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 clat Pharmaceuticals in March 2012 included the issuance
of a $12 million note, whose repayment is tied to the approval and net sales of certain clat products, 3.3 million warrants
and earn-out payments based on the gross profit achieved on the clat 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 clat 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 clat-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 clat-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 clat acquisition,
partially offset by interest earned on our cash balance. In the fourth quarter of 2011, the Company had interest income of $0.1
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.
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 clat 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- 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,
Last updated: Feb 28, 2013