Flamel Technologies (NASDAQ: FLML) today announced its financial
results for the first quarter of 2013. Highlights from the quarter
and subsequent period include:
- Management continues to focus on development and advancement of
internal near term projects as well as mid-term pipeline
opportunities that employ Flamel's proprietary drug delivery
technologies.
- Flamel has filed a second NDA with the US Food and Drug
Administration (FDA) in the first quarter.
- Management continues to pursue selective external business
development opportunities.
- Flamel had $15.4 million of cash and marketable securities as
of March 31, 2013, subsequent to the debt financing.
"We continue to be pleased with our progress in developing
products from the acquired Éclat portfolio and are excited about
the expected approval and launch of our first product in the summer
of 2013," said Mike Anderson, Chief Executive Officer of Flamel.
"We are still working to submit additional new drug applications as
soon as possible and filed a second NDA in the quarter. For this
second NDA, we have received a 'refusal to file' letter from the
FDA, citing our need to reformat parts of certain datasets in the
application. The letter does not comment on the approvability of
our product and we will continue to work closely with the agency to
provide the information requested for resubmission of this
application as quickly as possible. While this is disappointing,
given the limited nature of the deficiency, we have confidence in
being able to resubmit our filing shortly in accordance with FDA
requirements. Moreover, we continue to push forward developing
additional, innovative drugs that employ Flamel's proprietary
platform of technologies."
Greater research and development spending on these efforts is
designed to build Flamel's near-term and mid-term pipeline and
revenues and to build the company's shareholder value. The company
expects to perform clinical trials on two internal pipeline
products in the second half of 2013. Additionally, Flamel announced
the dismissal of a 2007 class action law suit during the first
quarter, resulting in the reimbursement of the $0.5 million
deductible.
"We continue to execute on our strategy to strike a balance
between our own pipeline products, where we control decisions on
development, regulatory submission and marketing, while continuing
our commitment to enter into significant partnerships that employ
Flamel's proprietary drug delivery platforms," said Mr. Anderson.
"In the near term, our new strategy of funding and developing our
own products could lower partner-derived revenue, but will provide
a much larger revenue base in the mid and long terms. 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."
Flamel's First Quarter Results
Flamel reported total revenues during the first quarter of 2013
of $5.1 million versus $7.4 million in the first quarter of 2012.
For the first quarter of 2013, a decrease of $1.3 million in
product sales and services was the primary driver of lower revenues
versus the prior year period. License and research revenues were
$1.3 million during the first quarter of 2013 compared to $2.1
million in the prior year quarter, reflecting the absence of new
contracts. Product sales were $2.1 million in the first quarter of
2013 compared to $3.4 million in the prior year period. The decline
is primarily due to the timing of demand from GlaxoSmithKline
("GSK") and recognition in the first quarter of 2012 of the
remaining $0.9 million of indemnity payments due to the Company
following the signature of a new supply agreement in 2011. Other
revenues, consisting primarily of royalty income from GSK on the
sales of Coreg CR, were $1.8 million in the first quarter of 2013
versus $1.9 million in the prior year quarter.
Total costs and expenses during the first quarter of 2013
increased to $15.0 million versus $7.4 million in the prior year
period. The total costs and expenses for the first quarter of 2013
increased due to several items. First, the Company incurred Éclat
expenses for the full first quarter of 2013 compared to March 13-
31, 2012 in the prior year period, resulting in an increase of $1.4
million in expenses (excluding the filing fee mentioned below)
included in both R&D and SG&A expenses. Second, Flamel
incurred a $2 million filing fee for its second new drug
application NDA filed with the FDA, offset by reduced SG&A
costs. Third, the value of the warrants issued for the acquisition
of Éclat has increased over the quarter as a result of our share
price, resulting in an accounting non-cash expense of $3.0 million
in the first quarter of 2013 compared with a favorable adjustment
of $5.1 million in the first quarter of 2012.
Costs of goods and services sold for the first quarter of 2013
were $1.0 million compared to $1.3 million in the first quarter of
2012 due to lower product sales. Research and development costs in
the first quarter of 2013 totaled $8.5 million versus $6.0 million
in the prior year period primarily due to the Company's expanding
portfolio of new internal pipeline products in development,
including the $2 million filing fee. Selling, general and
administrative expenses for the first quarter of 2013 decreased to
$2.5 million compared to $5.2 million in the year-prior period due
to severance costs incurred in the first quarter of 2012 upon the
departure of the Company's previous Chief Executive Officer and
legal costs associated with the acquisition of Éclat.
The terms of acquisition of Éclat 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, the share price and interest
rates in so far as they influence the value of the warrants. An
unfavorable $3.0 million adjustment was realized in the first
quarter of 2013 from the updated fair-value measurement of these
liabilities, compared to a favorable adjustment of $5.1 million in
the prior year period. Excluding these adjustments, operating
expenses in the first quarter of 2013 decreased to $12.0 million
compared to $12.5 million in the first quarter of 2012.
Total interest expense of $0.4 million for the first quarter of
2013 includes interest on the debt financing completed during the
quarter. In the first quarter of 2012, the Company had interest
income of $0.2 million.
Net loss for the first quarter of 2013 was $8.8 million versus
net income of $12,000 in the year-ago period. Earnings per share
(both basic and diluted) was $(0.35) in the first quarter of 2013
versus $0.00 in the first quarter of 2012. Net loss and loss per
share (basic and diluted) for the first quarter of 2013, excluding
the impact of the re-measurement of the fair value of acquisition
liabilities, was $5.9 million and $0.23, respectively compared with
$5.1 million and $0.20 respectively in the prior year period.
A conference call to discuss these results and other updates is
scheduled for 8:30 AM Eastern Time on Tuesday, May
7, 2013. A question and answer period will follow management's
prepared remarks. To participate in the conference call, investors
are invited to dial 888-428-9473 (U.S. and Canada) or
+1-719-325-2315 (international). The conference ID number is
8200950. 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. and Canada) or
+1-719-457-0820 (international), with the passcode 8200950. 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 March 31,
----------------------------
2012 2013
------------- -------------
Revenue:
License and research revenue $ 2,110 $ 1,273
Product sales and services 3,378 2,107
Other revenues 1,872 1,760
------------- -------------
Total revenue 7,360 5,140
------------- -------------
Costs and expenses:
Cost of goods and services sold (1,318) (995)
Research and development (5,985) (8,529)
Selling, general and administrative (5,183) (2,491)
Remeasurement of acquisition liabilities 5,080 (2,976)
------------- -------------
Total (7,406) (14,991)
------------- -------------
Profit (loss) from operations (46) (9,851)
Interest income (loss) net 166 (429)
Foreign exchange gain (loss) (133) 24
Other income (loss) 67 (35)
------------- -------------
Income (loss) before income taxes 54 (10,291)
Income tax benefit (expense) (42) 1,462
------------- -------------
Net Income (loss) $ 12 $ (8,829)
============= =============
Earnings (loss) per share
Basic earnings (loss) per ordinary share $ 0.00 $ (0.35)
Diluted earnings (loss) per share $ 0.00 $ (0.35)
Weighted average number of shares outstanding
(in thousands) :
Basic 25,012 25,415
Diluted 25,012 25,415
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