Full Press Release Details
Flamel Technologies Announces Fourth
And Year-End 2011 Results
Flamel to Acquire clat Pharmaceuticals;
Mike Anderson named Flamel CEO
Lyon, France - March 14, 2012 - Flamel
Technologies (NASDAQ: FLML) today announced its financial results for the fourth quarter and year ended December 31, 2011.
Separately, the Company also announced
today that it has agreed to acquire clat Pharmaceuticals, a St. Louis, Missouri-based special pharmaceutical company focused on
developing and commercializing niche brands and generic products. clat Pharmaceuticals is a wholly owned subsidiary of an affiliate
of Deerfield Capital L.P., which together with its other affiliates is our largest shareholder. Steve Willard, Flamel's current
chief executive officer, has resigned as CEO, and Mike Anderson, clat's chief executive officer, has become chief executive
officer of Flamel Technologies. Mr. Willard will remain a director of Flamel and an employee of a US subsidiary of Flamel. A press
release announcing these changes is available at www.flamel.com
Fourth Quarter and Recent Highlights:
Mr. Willard stated, "The issuance
of our new Micropump patent and its inclusion in the FDA Orange Book is, I believe, a very significant event, in that it is a
major expansion of our Micropump technology intellectual property. The new patent covers the delivery of microparticles with varying
release profiles, such that we can better match or improve the delivery of oral molecules. Because it is used in Coreg CR, the
grant of this patent may strengthen the ability to defend Coreg CR in the future. It also will be helpful in our efforts to expand
significantly into partnerships or other transactions for our Micropump platform, including our patented long-acting stable liquid
formulations (i.e., LiquiTime)."
Mr. Willard continued, "We are approaching
completion of our Phase 2 clinical trial on Interferon alpha. We have a number of other partnered projects in various clinical
trials and we continue working to execute on the initiatives we have discussed on our recent public conference calls."
Flamel's Fourth Quarter Results
Flamel reported total revenues for the
fourth quarter 2011 of $8.6 million versus total revenues of $13.5 million in the year-ago period; total revenues in the fourth
quarter of 2010 included a milestone payment of 3 million from Merck Serono that resulted from the commencement of a Phase 1
clinical trial on an improved formulation of beta-interferon 1-a, as well as a separate 1 million milestone that was triggered
by certain technical achievements. License and research revenues were $2.2 million during the fourth quarter of 2011, versus $8.8
million in the fourth quarter of 2010. Product sales and services during the fourth quarter of 2011, related primarily to production
of Coreg CR microparticles, were $4.2 million versus $2.2 million during the year-ago quarter. Other revenues, consisting primarily
of royalty income from GSK on the sales of Coreg CR, were $2.2 million as compared to $2.4 million in the fourth quarter of 2010.
Total costs and expenses during the fourth
quarter of 2011 declined to $10.9 million versus $11.4 million in the year-ago period. Costs of goods and services sold for the
fourth quarter 2011 were comparable with the prior year at $1.9 million. Research and development costs in the fourth quarter of
2011 totaled $5.9 million versus $6.9 million in the year-ago period. Selling, general, and administrative costs were $3.2 million
in the fourth quarter 2011 versus $2.7 million in the fourth quarter of 2010.
Net loss for the fourth quarter of 2011
was ($2.1 million) versus net income of $2.7 million in the year-ago period. Net loss per share (basic and diluted) was ($0.08)
versus net income per share (basic and diluted) of $0.11 in the fourth quarter of 2010.
Flamel's 2011 Annual Results
For the calendar year 2011, Flamel reported
total revenues of $32.6 million, compared to $37.1 million in 2010. License and research revenue during 2011 was $10.6 million
versus $19.7 million in 2010. Product sales and services for the year 2011 increased to $13.4 million, from $8.2 million in the
year-ago period. Other revenues, consisting primarily of royalty income from sales of Coreg CR by GSK, totaled $8.6 million in
2011 versus $9.2 million in 2010.
Total costs and expenses declined in 2011
to $42.2 million from $46.9 million in 2010. Costs of goods and services sold declined as well, to $6.3 million in 2011 versus
$6.9 million in 2010. Research & development expenses were $25.1 million versus $28.7 million in 2010. SG&A in 2011 totaled
$10.8 million versus $11.3 million in 2010.
The Company reported a net loss for the
year 2011 of ($8.8 million) or ($0.36) per share versus a net loss in 2010 of ($9.0 million), or ($0.37) per share. Flamel finished
2011 with $24.5 million in cash and marketable securities.
The Company is also updating its legal
proceeding disclosure, noting that on March 6, 2012, the US District Court for the Southern District of New York issued its opinion
granting the lead plaintiff's motion for class certification in the pending Billhofer v. Flamel Technologies, et al.
securities litigation. The Company intends to continue to defend itself vigorously in this matter.
A conference call to discuss these results
as well as the acquisition of clat Pharmaceuticals is scheduled for 8:30 AM Eastern Daylight Time Thursday, March 15,
2012. A question and answer period is scheduled to follow management's prepared remarks. The dial in number is 1-888-256-9132.
The conference ID number is 4062934. The conference call webcast may be accessed at www.flamel.com.
About Flamel Technologies. Flamel
Technologies SA (NASDAQ: FLML) is a leading drug delivery company focused on the goal of developing safer, more efficacious
formulations of drugs that address unmet medical needs. Its product development pipeline includes biological and chemical
drugs formulated with the Medusa and Micropump proprietary platforms. Several Medusa-based products are at various
clinical stages of development; Medusa's lead internal product candidate IFN-alpha XL (long-acting interferon alpha-2b)
is being evaluated a Phase 2a trial in HCV patients. The Company has developed approved 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)
and Merck Serono (long acting interferon beta 1a). Additional information can be found at
About Medusa . The Medusa
drug delivery platform consists of proprietary hydrogels for the formulation and/or the extended release of a broad range of biologics
(including proteins, antibodies, peptides and vaccines) and of small molecules (injectable drugs). The hydrogel, which are easy
and cost effective to produce under EMA/FDA cGMP guidance, has been proven to be safe and biodegradable: Flamel Technologies filed
a DMF for Medusa with the FDA on February 12, 2011 (assigned number 024634). Medusa enables the controlled delivery from 1 day
up to 14 days of non-denatured or non-modified drugs that remain fully active (as distinguished to protein engineering or chemical
modification approaches). It is used to develop biobetters with potentially improved efficacy and reduced toxicity, as well as
greater patient convenience. Additional information can be found at www.flamel.com/technology-platforms/medusa/.
About Micropump . The Micropump
micro-encapsulation drug delivery platform (oral drugs) is designed to increase the absorption time of drugs, particularly for
drugs only absorbed in the small intestine. Micropump enables the achievement of precise pharmacokinetics Micropump can be presented
in various dosage forms such as capsules, tablets, sachets or oral suspensions (LiquiTime ) without modifying the release rate.
Flamel develops also another drug delivery technology for oral drugs, i.e. Trigger Lock for the controlled release of narcotic
and opioid analgesics while deterring tampering (particles cannot be crushed to extract the active). Additional information can
be found at www.flamel.com/technology-platforms/micropump/.
| Contacts: | Stephen H. Willard | |
| Phone: | + 33 (0)4 7278 3434 | |
| Fax: | + 33 (0)4 7278 3435 | |
| E-mail: | willard@flamel.com |
This document 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," 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 will not be successful, clinical trial results will not be positive or that
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, and the risks associated with Flamel's reliance on outside parties and key strategic alliances. These and other
risks are described more fully in Flamel's Annual Report on the Securities and Exchange Commission Form 20-F for the year ended