Flamel Technologies (NASDAQ: FLML) today announced its financial
results for the third quarter of 2012. Highlights from the quarter
and subsequent period include:
- Flamel's New Drug Application (NDA) was accepted by the FDA in
October 2012 with Prescription Drug User Fee Act (PDUFA) target
action date of May 31, 2012.
- If approved, this new hospital-based product under FDA review
is expected to have peak annual revenue potential of $25 to $35
million with gross margins comparable to those generated in the
proprietary pharmaceutical business.
- On November 2, 2012, Flamel received notice from Merck Serono
that it has decided to terminate for convenience its development
and license agreement with Flamel for long-acting interferon
beta-1a (IFN-β XL).
- Management is continuing to advance internal pipeline and
aggressive pursuit of external business development
opportunities.
- Flamel had $15.6 million of cash and marketable securities as
of September 30, 2012.
"The recent acceptance of our NDA is an important milestone in
our transition into a more independent commercial-stage company,"
stated Mike Anderson, Flamel's chief executive officer. Mr.
Anderson continued, "Unfortunately, we believe that while the
technology was progressing, the IFN-β XL product's profile and its
development timelines no longer met Merck Serono's commercial
needs. Despite this termination, we will continue to work toward
making steady progress in both the innovative and project-based
sides of our business, and look forward to sharing updates in the
future. We recognize that the ability to complement our core
revenue streams with new proprietary products is key to providing
both sustainable revenue and earnings growth for Flamel."
Flamel's Third Quarter Results
Flamel reported total revenues during the third quarter of 2012
of $5.4 million versus $10.4 million in the year-ago period. The
decrease was primarily driven by lower product sales and services,
as the third quarter 2011 included an up-front payment and modified
pricing structure for purchases of Coreg CR's microparticles that
resulted from the signing of a new supply agreement with GSK.
License and research revenues were $1.7 million during the third
quarter of 2012 versus $2.7 million in the third quarter of 2011,
reflecting in part the aforementioned slowdown in development
efforts for IFN-β XL. Product sales and services during the third
quarter of 2012 were $2.1 million versus $5.2 million during the
year-ago quarter. Other revenues in the third quarter of 2012,
consisting primarily of royalty income from GSK on the sales of
Coreg CR, were $1.6 million versus $2.5 million in the third
quarter of 2011.
Total costs and expenses during the third quarter of 2012
increased to $10.4 million versus $9.2 million in the year-ago
period. Costs of goods and services sold for the third quarter of
2012 were $1.5 million compared to $1.1 million in the third
quarter of 2011. Research and development costs in the third
quarter of 2012 totaled $6.2 million versus $5.5 million in the
year-ago period. This increase was primarily a result of increased
spending to support the Company's expanded proprietary pipeline.
Selling, general, and administrative costs were $3.1 million in the
third quarter of 2012 versus $2.6 million in the third quarter of
2011, primarily resulting from to $0.7 million in Éclat-related
expenses in the third quarter of 2012 not present during the
prior-year period, partially offset by certain cost-saving
measures. Total interest expense of $1.4 million includes $1.5
million of non-cash expense related to calculated interest expense
on the consideration payable on the Éclat transaction, partially
offset by interest earned on our cash balance.
Net loss for the third quarter of 2012 was $6.4 million versus a
net income of $1.7 million in the year-ago period. Net loss per
share (basic and diluted) was $0.26 versus earnings per share
(basic and diluted) of $0.07 in the third quarter of 2011. Net loss
and loss per share (basic and diluted) for the third quarter of
2012 excluding the impact of the re-measurement of the fair value
of acquisition liabilities was $5.3 million and $0.21,
respectively.
A conference call to discuss these results and other updates is
scheduled for 8:30 AM Eastern Standard Time
Monday, November 5, 2012. A question and answer period will
follow management's prepared remarks. To participate in the
conference call, investors are invited to dial 888-438-5524. The
conference ID number is 9243089. 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
+1-719-457-0820 (international), with the passcode 9243089. A
replay of the webcast will also be archived on Flamel's website for
90 days following the call. To access the webcast, please use the
following link:
http://www.visualwebcaster.com/event.asp?id=90493.
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; Medusa's lead internal
product candidate IFN-alpha XL (long-acting interferon alpha-2b) is
completing a Phase 2 trial in HCV patients for which the latest
results will be presented at the American Association for the Study
of Liver Diseases (AASLD 2012) held on Nov. 9-13 in Boston. 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 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 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 Nine months ended
September 30, September 30,
-------------------- --------------------
2011 2012 2011 2012
--------- --------- --------- ---------
Revenue:
License and research revenue $ 2,700 $ 1,710 $ 8,396 $ 5,874
Product sales and services 5,239 2,063 9,153 7,494
Other revenues 2,495 1,625 6,402 5,423
--------- --------- --------- ---------
Total revenue 10,434 5,398 23,951 18,791
--------- --------- --------- ---------
Costs and expenses:
Cost of goods and services
sold (1,129) (1,500) (4,434) (4,365)
Research and development (5,475) (6,246) (19,179) (19,953)
Selling, general and
administrative (2,590) (3,107) (7,644) (11,203)
Remeasurement of acquisition
liabilities - 417 - 7,172
--------- --------- --------- ---------
Total (9,194) (10,436) (31,257) (28,349)
--------- --------- --------- ---------
Profit (loss) from operations 1,240 (5,038) (7,306) (9,558)
Interest income (loss) net (1) 147 (1,355) 472 (2,796)
Foreign exchange gain (loss) 375 (95) 155 (72)
Other income (loss) (12) 15 129 91
--------- --------- --------- ---------
Income (loss) before income
taxes 1,750 (6,473) (6,550) (12,335)
Income tax benefit (expense) (47) 48 (133) 5
--------- --------- --------- ---------
Net income (loss) $ 1,703 $ (6,425) $ (6,683) $ (12,330)
========= ========= ========= =========
Earnings (loss) per share
Basic earnings (loss) per
ordinary share $ 0.07 $ (0.26) $ (0.27) $ (0.49)
Diluted earnings (loss) per
share $ 0.07 $ (0.26) $ (0.27) $ (0.49)
Weighted average number of
shares outstanding (in
thousands) :
Basic 24,646 25,157 24,646 25,109
Diluted 24,971 25,157 24,646 25,109
(1) Includes impact of passage of time on valuation of acquisition
liabilities.
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