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Flamel Technologies Reports Fourth Quarter and Full Year 2015 Results Full year product revenues of $173.2 million and diluted EPS of $0.93 Reaffirms 2016 revenue guidance of $110 million to $130 million Lyon, France

Key Takeaway: Flamel Technologies Reports Fourth Quarter and Full Year 2015 Results Full year product revenues of $173.2 million and diluted EPS of $0.93 Reaffirms 2016 revenue guidance of $110 million to $130 million Lyon, France - March 10, 2016 - Flamel Technologies (NASDAQ: FLML) to

Full Press Release Details

Flamel Technologies Reports Fourth Quarter
and Full Year 2015 Results
Full year product revenues of $173.2
million and diluted EPS of $0.93
Reaffirms 2016 revenue guidance of
$110 million to $130 million
Lyon, France - March 10, 2016
- Flamel Technologies (NASDAQ: FLML) today announced its financial results for the fourth quarter and full year of 2015.
Fourth Quarter Highlights Include:
Michael Anderson, Flamel's Chief
Executive Officer, commented, "2015 was an exciting and productive year for the Company during which we set and then achieved
a number of important goals: We began the year by setting revenue guidance of $170 - $185 million and achieved our goal by generating
$173.2 million in revenues, principally from our marketed products, Bloxiverz and Vazculep . Following our global reorganization
at the end of 2014, we made key senior level hires during 2015 to support our rapid growth, including a Chief Financial Officer,
a SVP of Quality and Regulatory Affairs, a VP of Strategic Marketing and a VP of Business and Corporate Development."
"In addition to meeting full year
guidance, Flamel outlined a number of expected clinical milestones at the beginning of 2015 and subsequently reported positive
data on each, including Trigger Lock hydromorphone, Medusa exenatide and LiquiTime guaifenesin. We executed
our strategy to license the LiquiTime technology to a major OTC marketer, Perrigo, through its subsidiary Elan Pharma International
Limited, a deal from which we expect to see at least $50 million in milestone payments in addition to mid-single digit royalties
on a minimum of seven products. This license is a tremendous validation of our product-delivery technology and going forward we
expect to apply that technology to a number of prescription products where we believe it can fulfill a number of unmet medical
needs. During the third quarter of 2015, we received FDA acceptance of our third NDA for clat #3, and have an expected
PDUFA date of April 30th."
Mr. Anderson concluded, "We are very
pleased with the excellent progress we made during 2015, and are even more excited about 2016, during which we will be running
several pivotal trials, the most important of which is Micropump sodium oxybate, as well as launching clat #3 and unveiling
several new prescription product candidates for use with LiquiTime . Our acquisition of FSC Pediatrics in early February provides
Flamel with four new commercial stage products, three of which are IP protected, and an established commercial infrastructure.
We plan to leverage this infrastructure as the Company continues to expand and become a more diversified specialty pharmaceutical
company with world-class drug delivery technologies that address unmet medical needs and underserved patient populations."
Fourth Quarter 2015 Results
The Company achieved revenues during the
fourth quarter of 2015 of $43.4 million, compared to $3.0 million during the same period last year. On a GAAP basis, Flamel had
net income of $76.1 million during the fourth quarter, or $1.75 per diluted share, compared to a net loss of ($27.1) million, or
($0.69) per diluted share, in the prior year period. Adjusted net income was $13.9 million, or $0.32 per diluted share, compared
to an adjusted net loss of ($9.7) million, or ($0.25) per diluted share, during the same period last year. Adjusted net income
increased over the prior year principally as a result of substantially higher revenues from Bloxiverz and Vazculep in
2015 compared to 2014. Included in GAAP net income in the fourth quarter 2015 was a $51.1 million gain resulting from the reduction
of the Company's contingent consideration liability. The Company reassessed its long term sales forecast and reduced its
contingent consideration liability primarily due to the December 28, 2015 FDA announcement of a generic version of neostigmine,
creating a market of three approved providers, exclusive of Merck's sugammadex approval. Please see the appendix to this
earnings release for a reconciliation of adjusted net income and diluted EPS to GAAP net income and diluted EPS.
Full Year 2015 Results
Flamel met its full year
2015 revenue guidance by generating $173.2 million in revenues, compared to $14.8 million in 2014. GAAP net income for 2015 was
$40.7 million, or $0.93 per diluted share, compared to a net loss of ($84.9) million, or ($2.34) per diluted share, in 2014. Adjusted
net income was $43.1 million, or $0.99 per diluted share, compared to an adjusted net loss of ($24.6) million, or ($0.68) per diluted
share, in 2014. Adjusted net income increased over the prior year principally as a result of substantially higher revenues from
Bloxiverz and Vazculep in 2015 compared to 2014. Cash flow from operations was $84.3 million compared to cash used in
operations of $(10.6) million in the same period last year. Cash and marketable securities at December 31, 2015 were $144.8 million,
compared to $128.4 million on September 30, 2015 and $92.8 million at December 31, 2014.
2016 Revenue and R&D Spending Guidance
Following the Company's acquisition
of FSC Pediatrics (FSC) on February 8, 2016, Flamel updated its 2016 full year revenue guidance from $100 - $120 million to $110
- $130 million. The Company expects newly acquired FSC products, AcipHex Sprinkle , Karbinal ER, Cefaclor for
Oral Suspension and Flexichamber , to generate revenues in the range of $10 - $15 million in 2016. As a result of the multiple
clinical trials expected to run throughout 2016, the Company expects Research & Development costs to be in the range of $35
- $50 million, up from $25.6 million in 2015.
A conference call to discuss these results
and other updates is scheduled for 10:00 a.m. ET on Thursday, March 10, 2016. A question and answer period will follow management's
prepared remarks. To participate in the conference call, investors are invited to dial 888-215-7015 (U.S. and Canada) or 913-312-0687
(international). The conference ID number is 9724678. Interested parties may access a live audio webcast of the conference call
via the investor section of the Company website, www.flamel.com. The archived webcast of the conference call will be available
for 90 days on Flamel's website.
About Flamel Technologies:
Flamel Technologies SA (NASDAQ: FLML) is
a specialty pharmaceutical company utilizing its core competencies in formulation development and drug delivery to develop safer
and more efficacious pharmaceutical products, addressing unmet medical needs and/or reducing overall healthcare costs. Flamel currently
markets two previously Unapproved Marketed Drugs ("UMDs") in the United States, Bloxiverz (neostigmine methylsulfate
injection) and Vazculep (phenylephrine hydrochloride injection), and in September 2015 announced that the NDA for its third
UMD filing was accepted by the FDA and assigned a PDUFA date of April 30, 2016. The Company also develops products utilizing its
proprietary drug delivery platforms, Micropump (oral sustained release microparticles platform), along with its tangent technologies,
LiquiTime (a Micropump-derivative platform for liquid oral products) and Trigger Lock (a Micropump-derivative platform
for abuse-resistant opioids). Additionally, the Company has developed a long acting injectable platform, Medusa , a hydrogel
depot technology, particularly suited to the development of subcutaneously administered formulations. Current applications of Flamel's
drug delivery products include sodium oxybate (Micropump ), extended-release of liquid medicines such as ibuprofen and guaifenesin
(LiquiTime , through a license arrangement with Elan Pharma International Limited for the U.S. Over-the-Counter market) and
a current study of the delivery of exenatide utilizing the Medusa technology. In February 2016, Flamel acquired FSC Pediatrics,
a Charlotte, North Carolina-based company that markets three pediatric pharmaceutical products - Cefaclor for oral suspension,
indicated for infection, Karbinal ER, indicated for allergic rhinitis and AcipHex Sprinkle (rabeprazole sodium)
indicated for the treatment of gastroesophageal disease (GERD). FSC also received 510(k) clearance from the FDA in October 2014
for Flexichamber , a collapsible holding chamber for used in the administration of aerosolized medication using pressurized
Metered Dose Inhalers (pMDIs) for the treatment of asthma. The Company is headquartered in Lyon, France and has operations in Dublin,
Ireland and in the USA in both St. Louis, Missouri and Charlotte, North Carolina. Additional information may be found at www.flamel.com.
Safe Harbor: This release
may include "forward-looking statements" within the meaning of the Private Securities Litigation Reform Act of 1995.
All statements herein that are not clearly historical in nature are forward-looking, and the words "anticipate," "assume,"
"believe," "expect," "estimate," "plan," "will," "may," and the negative
of these and similar expressions generally identify forward-looking statements. All forward-looking statements involve risks, uncertainties
and contingencies, many of which are beyond Flamel's control and could cause actual results to differ materially from the results
contemplated in such forward-looking statements. These risks, uncertainties and contingencies include the risks relating to: our
dependence on a small number of products and customers for the majority of our revenues; the possibility that our Bloxiverz
and Vazculep products, which are not patent protected, could face substantial competition resulting in a loss of market share
or forcing us to reduce the prices we charge for those products; the possibility that we could fail to successfully complete the
research and development for the two pipeline products we are evaluating for potential application to the FDA pursuant to our "unapproved-to-approved"
strategy, or that competitors could complete the development of such products and apply for FDA approval of such products before
us; our dependence on the performance of third parties in partnerships or strategic alliances for the commercialization of some
of our products; the possibility that our products may not reach the commercial market or gain market acceptance; our need to invest
substantial sums in research and development in order to remain competitive; our dependence on certain single providers for development
Last updated: Mar 10, 2016