Full Press Release Details
Flamel Technologies Reports First Quarter
Total revenues of $36.2 million
Adjusted net income of $1.6 million
and adjusted diluted EPS of $0.04
Adjusted EBITDA of $11.8 million
Cash flow from operations of $22.5
Lyon, France - May 9, 2016
- Flamel Technologies (NASDAQ: FLML) today announced its financial results for the first quarter of 2016.
First Quarter Highlights Include:
Michael Anderson, Flamel's Chief
Executive Officer, commented, "We were pleased with our strong revenues of $36.2 million during the first quarter. The entrance
of a third competitor to the neostigmine market in December 2015 was less impactful to pricing and share for Bloxiverz during
the first quarter than initially anticipated; however, we still expect a decline in market share throughout the year to approximately
30% to 35%. As expected on April 29th, we received FDA approval for our third unapproved marketed drug, Akovaz ,
which is our formulation of ephedrine sulfate injection. Following launch in the third quarter of this year, Akovaz will provide
yet another stream of cash flow to help us continue executing against our strategic plan of advancing our pipeline products and
growth through acquisitions, the first of which we made early in the first quarter. We continue to focus on integrating the FSC
business and revenues are meeting our expectations. We are particularly excited by physicians' reception of Karbinal
ER, which accounted for the majority of revenues from the FSC product portfolio."
Mr. Anderson continued, "At the end
of the first quarter, we submitted our SPA to the FDA for our pivotal trial of Micropump sodium oxybate, which will provide
the FDA an opportunity to review our trial protocol and provide feedback. We expect to begin patient registration for our pivotal
trial in mid-year 2016. We view sodium oxybate as our most valuable pipeline asset, and will continue to take the necessary steps
to ensure the Company returns maximum value to our shareholders."
First Quarter 2016 Results
Company achieved revenues during the first quarter of 2016 of $36.2 million, compared to $32.7 million during the same period last
year. On a GAAP basis, Flamel recorded a net loss of ($6.4) million during the first quarter, or ($0.15) per diluted share, compared
to a net income of $11.6 million, or $0.27 per diluted share, for the same period last year. Adjusted net income for the first
quarter was $1.6 million, or $0.04 per diluted share, compared to an adjusted net income of $4.7 million, or $0.11 per diluted
share, during the same period last year. The decline in adjusted diluted EPS from the previous year was primarily due to higher
SG&A resulting from investments made in infrastructure and people in order to execute the Company's strategic plan. Included
in GAAP net loss in the first quarter of 2016 was a $7.9 million charge to its contingent consideration liability resulting from
the Company's reassessment of its long term clat revenue forecast. In addition, the Company incurred a foreign currency
exchange loss of ($2.9) million, compared to a foreign currency exchange gain of $11.5 million in the prior year quarter. Please
see the Supplemental Information section within this document for a reconciliation of adjusted
EBITDA, adjusted net income and adjusted diluted EPS to the respective GAAP amounts.
Cash flow from operations was $22.5 million,
compared to $25.3 million in the same period last year. Cash and marketable securities at March 31, 2016 were $160.0 million, compared
to $144.8 million at December 31, 2015, an increase of $15.2 million.
2016 Revenue and R&D Spending Guidance
The Company is maintaining its full year
2016 revenue guidance of $110 - $130 million and expects the recently acquired FSC products, AcipHex Sprinkle , Karbinal
ER, Cefaclor for Oral Suspension and Flexichamber , to contribute revenues in the range of $10 - $15 million. As a result
of the multiple clinical trials expected to run throughout 2016, the Company expects research & development expenses to be
in the range of $35 - $50 million, up from $25.6 million in 2015.
call to discuss these results and other updates is scheduled for 10:00 a.m. ET on Monday, May 9, 2016. A question and answer period
will follow management's prepared remarks. To participate in the conference call, investors are invited to dial 800-753-0420
(U.S. and Canada) or 913-312-0645 (international). The conference ID number is 3821495. 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 received approval for its third, Akovaz on April
29, 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 ,Vazculep
and Akovaz 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 pipeline product 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 product and apply for FDA approval of such product 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
of several of our drug delivery platforms and products; our dependence on a limited number of suppliers to manufacture our products
and to deliver certain raw materials used in our products; the possibility that our competitors may develop and market technologies
or products that are more effective or safer than ours, or obtain regulatory approval and market such technologies or products
before we do; the challenges in protecting the intellectual property underlying our drug delivery platforms and other products;
our dependence on key personnel to execute our business plan; the amount of additional costs we will incur to comply with U.S.
securities laws as a result of our ceasing to qualify as a foreign private issuer; and the other risks, uncertainties and contingencies
described in the Company's filings with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K for
the year ended December 31, 2015, all of which filings are also available on the Company's website. Flamel undertakes no obligation
to update its forward-looking statements as a result of new information, future events or otherwise, except as required by law.
Non GAAP Disclosures and Adjustments
Flamel discloses certain non-GAAP financial
measures, including adjusted net income and loss and adjusted net income andloss per diluted share and earnings before interest,
taxes, depreciation and amortization (EBITDA) as management believes that a comparison of its current and historical results would
be difficult if the disclosures were limited to financial measures prepared only in accordance with generally accepted accounting
principles (GAAP) in the U.S. In addition to reporting its financial results in accordance with GAAP, Flamel reports certain non-GAAP