Recent Updates
Recently added Catalysts
AVDL

Flamel Technologies Announces Fourth Quarter and Full Year 2013 Results Company closes sale of 12.4 million American Depositary Shares for $113 million of net proceeds in first quarter of 2014 Conference call with manage

Key Takeaway: Flamel Technologies Announces Fourth Quarter and Full Year 2013 Results Company closes sale of 12.4 million American Depositary Shares for $113 million of net proceeds in first quarter of 2014 Conference call with management to take place at 10:00 AM EST on March 25, 2014 L

Full Press Release Details

Flamel Technologies Announces Fourth
Quarter and Full Year 2013 Results
Company closes sale of 12.4 million
American Depositary Shares for $113 million of net proceeds in first quarter of 2014
Conference call with management to
take place at 10:00 AM EST on March 25, 2014
Lyon, France - March 25, 2014
- Flamel Technologies (NASDAQ: FLML) today announced its financial results for the fourth quarter and full year 2013. Highlights
from the quarter include:
In addition to these fourth quarter and
full year 2013 results, the Company announced on March 7, 2014 the sale of 12.4 million American Depositary Shares (ADSs) for approximately
$113 million of net proceeds to the Company. Flamel intends to use the net proceeds from the offering for the repayment of amounts
under the Deerfield Debt Financing, a $15.0 million principal amount which bears an interest rate of 12.5% and the Broadfin secured
line of credit, of which $5.0 million was drawn and bears an interest rate of 12.5%. The Company intends to use the remaining net
proceeds for the continued development of its product pipeline, including possible clinical trials, and general corporate purposes,
including working capital.
"We are excited to have completed
this major equity financing for Flamel in the first quarter of 2014. This is an important milestone for us as we look to expand
our development pipeline, repay outstanding debt and conduct additional clinical trials. The improved sales trend of Bloxiverz
is another highlight for this first quarter. While no sales were recognized in the fourth quarter of 2013 given minimal pull through
to the hospitals and US GAAP requirements, we have seen an increase in sales of Bloxiverz in the first quarter of 2014. With one
manufacturer of the unapproved version of neostigmine having withdrawn from the marketplace and two manufacturers on back-order
status during parts of the first quarter, we are encouraged by our recent sales level to the end-users. We anticipate generating
solid revenue growth from Bloxiverz through 2014 and look forward to updating investors on Bloxiverz specifics when we discuss
our financial results for the first quarter of 2014," said Mike Anderson, Chief Executive Officer of Flamel.
"We were also pleased to announce
the $15.0 million secured line of credit we established with Broadfin Capital in December. Flamel drew down the initial $5 million
tranche from the line of credit in December, which allowed us to support the launch of Bloxiverz, the advancement of our R&D
pipeline and new drug submissions. Subsequently, we are pleased that Flamel was able to complete an equity financing which allows
the Company to repay our debt and to strengthen Flamel's balance sheet for future growth," Mr. Anderson added.
Flamel's Fourth Quarter Results
Flamel reported total revenues during the
fourth quarter of 2013 of $6.2 million versus $7.3 million in the fourth quarter of 2012. The decrease was primarily driven by
lower license and research revenue of $2.4 million in the fourth quarter of 2013, compared to $3.5 million in the prior year quarter,
due to impact of the termination of its agreement with Merck-Serono in the fourth quarter of 2012 when the company recognized the
remaining upfront license fee. Product sales and services revenues in the fourth quarter of 2013 of $2.2 million were comparable
to the fourth quarter of 2012. This decline in external revenue correlates with the company's transition from a drug delivery
company to a self-funded specialty pharma company.
Costs of goods and services sold for the
fourth quarter of 2013 were $335,000 compared to $1.5 million in the fourth quarter of 2012. This reduction was due to optimized
production scheduling and release of payroll accruals due to a change in the Company's compensation policy. Research and
development costs in the fourth quarter of 2013 totaled $4.2 million versus $6.2 million in the prior year period. R&D expense
was impacted equally by the release of payroll accruals and timing in development costs for the Company's internal portfolio.
Selling, general and administrative costs were $5.2 million in the fourth quarter of 2013, versus $3.0 million in the fourth quarter
of 2012, impacted by contractual severance indemnities the Company was required to accrue and includes employer's French
social charges, where applicable.
With the acquisition of clat, Flamel
acquired several pipeline products that management believed could be commercially attractive. As part of the acquisition, Flamel
has incurred obligations owed to the former clat shareholders that are contingent on the approval and market potential
for those products. These commitments are revalued and reassessed at each balance sheet date based on information and data available
at that time, resulting in non-cash income of $4.5 million and $14.9 million in the fourth quarters of 2013 and 2012, respectively.
Total interest expense was $600,000 for
the fourth quarter of 2013 due to additional debt incurred in January 2013 and the initial tranche of the line of credit. In the
fourth quarter of 2012, the Company had interest income of $98,000.
Net income for the fourth quarter of 2013
was $5.1 million versus net income of $9.1 million in the year-ago period. Earnings per share (both basic and diluted) was $0.20
in the fourth quarter of 2013 versus $0.36 in the fourth quarter of 2012.
Adjusted net loss for the fourth quarter
of 2013 was $0.1 million versus an adjusted net loss of $1.2 million in the fourth quarter of 2012. Adjusted loss per share (both
basic and diluted) was $0.00 in the fourth quarter of 2013 compared to an adjusted loss per share of $0.05 in the prior year period.
For the full year periods, adjusted net loss for 2013 was $16.1 million versus an adjusted net loss of $17.7 million for 2012.
Adjusted loss per share (both basic and diluted) was $0.63 for the full year 2013 compared to an adjusted loss per share of $0.70
in the prior year. A reconciliation of adjusted net loss is included below.
The Company's cash position as of
December 31, 2013 was $7.0 million, which includes $5.0 million drawn from the line of credit in the fourth quarter. The Company
continues to generate considerable tax benefit from operating losses that management expects to be able to offset against future
Flamel is disclosing non-GAAP financial
measures when providing financial results, including adjusted net income. Flamel believes that an evaluation of its ongoing operations
(and comparison of current operations with historical and future operations) would be difficult if the disclosure of its financial
results were limited to financial measures prepared only in accordance with generally accepted accounting principles (GAAP) in
the U.S. In addition to disclosing its financial results determined in accordance with GAAP, Flamel is disclosing certain non-GAAP
results that exclude items such as fair value remeasurements, impairment of intangible assets and amortization expense directly
associated with the acquisition and include items such as operating cash flows associated with the acquisition liabilities and
Royalty Agreements, in order to supplement investors' and other readers' understanding and assessment of the Company's financial
performance. The Company's management uses these non-GAAP measures internally for forecasting, budgeting and measuring its operating
performance. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of
non-GAAP measures to their most closely applicable GAAP measure set forth below and should consider non-GAAP measures only as a
supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with
Below is a reconciliation of GAAP net losses
attributable to Flamel and diluted GAAP losses per share to adjusted net losses attributable to Flamel and adjusted diluted losses
per share for the three months and year ended December 31, 2013 and 2012 (in thousands except per share amounts).
Three months ended December 31, Twelve months ended December 31,
2012 2013 2012 2013
GAAP Net income (loss) and diluted earnings (loss) per share $ 9,102 $ 0.36 $ 5,126 $ 0.20 $ (3,228 ) $ (0.13 ) $ (42,925 ) $ (1.69 )
Fair value remeasurement of acquisition liabilities (14,871 ) (4,507 ) (18,834 ) 28,135
Fair value remeasurement of royalty agreements - (38 ) - 1,990
Tax effects of the above items 295 (74 ) 258 (2,416 )
Asset Impairment net of tax effects 4,302 4,302
Earn-out acquisition payment payable (66 ) (565 ) (160 ) (840 )
Adjusted Net Income (Loss) and adjusted diluted earnings (loss) per share $ (1,238 ) $ (0.05 ) $ (58 ) $ (0.00 ) $ (17,661 ) $ (0.70 ) $ (16,057 ) $ (0.63 )
A conference call to discuss these results
and other updates is scheduled for 10:00 AM Eastern Standard Time on Tuesday, March 25, 2014. A question and answer period
will follow management's prepared remarks. To participate in the conference call, investors are invited to dial 888-437-9445
(U.S.) or 719-325-2354 (international). The conference ID number is 1187173. The conference
call webcast may be accessed at www.flamel.com. A replay of the webcast will be archived on Flamel's website for 90 days following
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.
Contact: Michael S. Anderson
Chief Executive Officer
Phone: 33 (0) 4 72 78 34 34
Fax: 33 (0) 4 72 78 34 35
E-mail: anderson@flamel.com
Investor Relations
Bob Yedid
ICR Inc .
Phone: 646-277-1250
Email: bob.yedid@icrinc.com
Last updated: Mar 25, 2014