Click here to close now.

Welcome!

News Feed Item

Flamel Technologies Announces Second Quarter of Fiscal Year 2014 Results

Company Received FDA Approval of Vazculep on June 30, 2014

LYON, FRANCE -- (Marketwired) -- 07/29/14 -- Flamel Technologies (NASDAQ: FLML) today announced its financial results for the second quarter of fiscal year 2014. Highlights from the quarter include:

  • Received U.S. Food and Drug Administration (FDA) approval of Vazculep® (phenylephrine hydrochloride) in the 1mL single use vials, and 5mL and 10mL pharmacy bulk package vials. Flamel is now the only drug manufacturer offering all three product presentations of phenylephrine hydrochloride injection and will launch before end of the third quarter 2014
  • The FDA updated its Drug Shortages website as of June 19, 2014 to reflect that the neostigmine methylsulfate shortage is resolved and cites Éclat Pharmaceuticals as the only listed supplier of the drug
  • First-in-Man clinical study of Micropump® technology applied to sodium oxybate identified formulations that demonstrate the potential to eliminate the second nighttime dose for patients suffering from narcolepsy. The Company is expanding the current trial and will test product at higher dosages

"We are pleased that the FDA listed Éclat Pharmaceuticals as the only supplier of neostigmine methylsulfate as of June 19th. We have been in frequent communication with the FDA with regard to Bloxiverz, and look forward to learning more about any specific actions in the near future," said Mike Anderson, Chief Executive Officer of Flamel.

"Additionally, we continue to execute on our strategy with FDA's recent approval of Vazculep," added Mr. Anderson. "Our prompt resubmission of our NDA for Vazculep and the FDA's subsequent approval ahead of the scheduled PDUFA date is an example of the Company's ability to work effectively and positively with the FDA and other third parties in order to execute our business plan."

We continue to make progress on our proprietary pipeline, including the clinical testing of sodium oxybate and other compounds using our Micropump®, LiquiTime®, Trigger Lock™, and Medusa™ drug delivery platforms. Continued prioritization of these programs and investments in our internal infrastructure will facilitate high quality and timely execution on our major proprietary pipeline products throughout 2014 and 2015.

Flamel's Second Quarter Results

Flamel reported total revenues during the second quarter of 2014 of $8.1 million, an increase of $2.5 million in revenues compared to the prior year period. Product sales and services revenues in the second quarter of 2014 of were $4.1 million, compared to $2.2 million in the prior year quarter, principally due to sales of Bloxiverz, which was not launched in the second quarter of 2013. On a sequential basis, second quarter 2014 revenues of $8.1 million were down from $9.2 million in the first quarter of 2014, due to a leveling off of Bloxiverz sales after a spike in sales in the first quarter when two suppliers of unapproved neostigmine methylsulfate were off the market for a portion of the quarter.

Costs of goods and services sold for the second quarter of 2014 were $1.6 million compared to $1.3 million in the second quarter of 2013, principally due to cost of sales of Bloxiverz. Research and development costs in the second quarter of 2014 totaled $6.7 million versus $7.3 million in the prior year period. Selling, general and administrative costs were $4.3 million in the second quarter of 2014 versus $2.7 million in the second quarter of 2013. This increase resulted from the cost of post-marketing studies requested by the FDA and increased legal costs. Amortization of R&D assets associated with the development of Bloxiverz was $2.9 million in the second quarter of 2014.

Total net interest income was $94,000 in the second quarter of 2014 compared to interest expense of $640,000 in the second quarter of 2013. Interest expense was largely eliminated with the Company's repayment of nearly all of its debt and lines of credit with a portion of the net proceeds from its offering of 12.4 million ADSs in mid-March 2014.

Net loss for the second quarter of 2014 was $21.1 million versus net loss of $32.8 million in the year-ago period. Earnings per share (both basic and diluted) was $(0.55) in the second quarter of 2014 versus $(1.29) in the second quarter of 2013.

Adjusted net loss for the second quarter of 2014 was $4.9 million versus an adjusted net loss of $4.5 million in the second quarter of 2013. Adjusted loss per share (both basic and diluted) was $(0.13) in the second quarter of 2014 compared to an adjusted loss per share of $(0.18) in the prior year period.

The Company's cash position as of June 30, 2014 was $77.9 million.

Flamel is disclosing non-GAAP financial measures when providing financial results, including adjusted net loss. Flamel believes that an evaluation of its ongoing operations (and comparison of current operations with historical and future operations) would be difficult if the disclosure of its financial results were limited to financial measures prepared only in accordance with generally accepted accounting principles (GAAP) in the U.S. In addition to disclosing its financial results in accordance with GAAP, Flamel is disclosing certain non-GAAP results that exclude fair value remeasurements, impairment of intangible assets, amortization expense of intangible assets and effects of accelerated reimbursement of certain debt instruments and include operating cash flows associated with the acquisition liabilities and Royalty Agreements, in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance. The Company's management uses these non-GAAP measures internally for forecasting, budgeting and measuring its operating performance. Investors and other readers are encouraged to review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most closely applicable GAAP measure set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP.

Below is a reconciliation of GAAP net losses attributable to Flamel and diluted GAAP losses per share to adjusted net losses attributable to Flamel and adjusted diluted losses per share for the three months and six months ended June 30, 2014 and 2013 (in thousands except per share amounts).



                                            Three months ended June 30,
                                        ----------------------------------
                                              2013              2014
                                        ----------------  ----------------
GAAP Net income (loss) and diluted
 earnings (loss) per share              $(32,854) $(1.29) $(21,073) $(0.55)

Fair value remeasurement of acquisition
 liabilities                              28,623            12,607
Fair value remeasurement of royalty
 agreements                                2,015             1,079
Amortization of Intangible R&D Assets          -             2,938
Accelerated reimbursement of
 acquisition note                              -                 -
Accelerated reimbursement of facility
 agreements                                    -                 -
Tax effects of the above items            (2,238)                -

Earn-out acquisition payment payable           -              (383)
Royalty payable                                -               (54)

                                        --------          --------
Adjusted Net Income (Loss) and adjusted
 diluted earnings (loss) per share      $ (4,454) $(0.18) $ (4,886) $(0.13)
                                        ========          ========





                                            Six months ended June 30,
                                       ----------------------------------
                                             2013              2014
                                       ----------------  ----------------
GAAP Net income (loss) and diluted
 earnings (loss) per share             $(41,683) $(1.64) $(47,711) $(1.43)

Fair value remeasurement of acquisition
 liabilities                             31,599            27,233
Fair value remeasurement of royalty
 agreements                               2,015             1,235
Amortization of Intangible R&D Assets         -             5,875
Accelerated reimbursement of
 acquisition note                             -             3,013
Accelerated reimbursement of facility
 agreements                                   -             4,741
Tax effects of the above items           (2,253)                -

Earn-out acquisition payment payable       (108)             (994)
Royalty payable                               -              (141)

                                       --------          --------
Adjusted Net Income (Loss) and adjusted
 diluted earnings (loss) per share     $(10,430) $(0.41) $ (6,750) $(0.20)
                                       ========          ========


A conference call to discuss these results and other updates is scheduled for 10:00 AM ET on Tuesday, July 29, 2014. A question and answer period will follow management's prepared remarks. To participate in the conference call, investors are invited to dial 888-428-9490 (U.S.) or 1+719-325-2376 (international). The conference ID number is 1681810. The conference call webcast may be accessed at www.flamel.com. A replay of the webcast will 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 markets Bloxiverz™ (neostigmine methylsulfate) in the USA and manufactures Micropump-based microparticles under FDA-audited GMP guidelines for Coreg CR® (carvedilol phosphate), marketed in the USA by GlaxoSmithKline. 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 pipeline includes chemical and biological drugs formulated with its Micropump® (and its applications to the development of liquid formulations LiquiTime® and of abuse-deterrent formulations Trigger Lock™) and Medusa™ proprietary drug delivery platforms. Several Medusa-based products have been successfully tested in clinical trials. 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 launch of Bloxiverz will not be as successful as anticipated; our ability to bring other R&D projects of the former Éclat Pharmaceuticals to market may be unsuccessful; FDA may not take action on the status of unapproved versions of neostigmine still on the market; clinical trial results may not be positive or our partners may decide not to move forward; 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, 2013 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   Six months ended
                                          June 30,            June 30,
                                     ------------------  ------------------
                                       2013      2014      2013      2014
                                     --------  --------  --------  --------
Revenue:
  License and research revenue       $  1,650  $  2,270  $  2,923  $  3,703
  Product sales and services            2,195     4,128     4,302    10,068
  Other revenues                        1,696     1,683     3,456     3,485
                                     --------  --------  --------  --------
    Total revenue                       5,541     8,081    10,681    17,256
                                     --------  --------  --------  --------
Costs and expenses:
  Cost of goods and services sold      (1,283)   (1,636)   (2,278)   (3,588)
  Research and development             (7,304)   (6,742)  (15,833)  (13,836)
  Amortisation of intangible R&D
   assets                                   -    (2,938)        -    (5,875)
  Selling, general and
   administrative                      (2,706)   (4,295)   (5,197)   (7,850)
  Fair value remeasurement of
   acquisition liabilities, incl.
   related parties                    (28,623)  (12,607)  (31,599)  (27,233)
  Acquisition note expenses, incl.
   related parties                          -         -         -    (3,013)
                                     --------  --------  --------  --------
    Total                             (39,916)  (28,218)  (54,907)  (61,395)
                                     --------  --------  --------  --------

Profit (loss) from operations         (34,375)  (20,137)  (44,226)  (44,139)

Interest income (Expense) net            (640)       94    (1,069)   (5,414)
Interest expense on debt related to
 the royalty agreement with related
 parties                               (2,015)   (1,079)   (2,015)   (1,235)
Foreign exchange gain (loss)              (33)      292        (9)      471
Other income (loss)                       501        30       466        82

                                     --------  --------  --------  --------
Income (loss) before income taxes     (36,562)  (20,800)  (46,853)  (50,235)
Income tax benefit (expense)            3,708      (273)    5,170     2,524
                                     --------  --------  --------  --------
  Net income (loss)                  $(32,854) $(21,073) $(41,683) $(47,711)
                                     ========  ========  ========  ========

Earnings (loss) per share

  Basic earnings (loss) per ordinary
   share                             $  (1.29) $  (0.55) $  (1.64) $  (1.43)
  Diluted earnings (loss) per share  $  (1.29) $  (0.55) $  (1.64) $  (1.43)

Weighted average number of shares
 outstanding (in thousands):

  Basic                                25,421    38,438    25,418    33,403
  Diluted                              25,421    38,438    25,418    33,403


More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

Latest Stories
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society-changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his session at @ThingsExpo, Jason Mondanaro, Director, Product Management at Metanga, discussed how you can plan to cooperate, partner, and form lasting all-star teams to change the world...
In the midst of the widespread popularity and adoption of cloud computing, it seems like everything is being offered “as a Service” these days: Infrastructure? Check. Platform? You bet. Software? Absolutely. Toaster? It’s only a matter of time. With service providers positioning vastly differing offerings under a generic “cloud” umbrella, it’s all too easy to get confused about what’s actually being offered. In his session at 16th Cloud Expo, Kevin Hazard, Director of Digital Content for SoftL...
"What Dyn is able to do with our Internet performance and our Internet intelligence is give companies visibility into what is actually going on in that cloud," noted Corey Hamilton, Product Marketing Manager at Dyn, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi’s VP Business Development and Engineering, will explore the IoT cloud-based platform technologies drivi...
Containers have changed the mind of IT in DevOps. They enable developers to work with dev, test, stage and production environments identically. Containers provide the right abstraction for microservices and many cloud platforms have integrated them into deployment pipelines. DevOps and Containers together help companies to achieve their business goals faster and more effectively. In his session at DevOps Summit, Ruslan Synytsky, CEO and Co-founder of Jelastic, reviewed the current landscape of...
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at @ThingsExpo, James Kirkland, Red Hat's Chief Arch...
IT data is typically silo'd by the various tools in place. Unifying all the log, metric and event data in one analytics platform stops finger pointing and provides the end-to-end correlation. Logs, metrics and custom event data can be joined to tell the holistic story of your software and operations. For example, users can correlate code deploys to system performance to application error codes. In his session at DevOps Summit, Michael Demmer, VP of Engineering at Jut, will discuss how this can...
The last decade was about virtual machines, but the next one is about containers. Containers enable a service to run on any host at any time. Traditional tools are starting to show cracks because they were not designed for this level of application portability. Now is the time to look at new ways to deploy and manage applications at scale. In his session at @DevOpsSummit, Brian “Redbeard” Harrington, a principal architect at CoreOS, will examine how CoreOS helps teams run in production. Attende...
Containers are revolutionizing the way we deploy and maintain our infrastructures, but monitoring and troubleshooting in a containerized environment can still be painful and impractical. Understanding even basic resource usage is difficult – let alone tracking network connections or malicious activity. In his session at DevOps Summit, Gianluca Borello, Sr. Software Engineer at Sysdig, will cover the current state of the art for container monitoring and visibility, including pros / cons and liv...
Live Webinar with 451 Research Analyst Peter Christy. Join us on Wednesday July 22, 2015, at 10 am PT / 1 pm ET In a world where users are on the Internet and the applications are in the cloud, how do you maintain your historic SLA with your users? Peter Christy, Research Director, Networks at 451 Research, will discuss this new network paradigm, one in which there is no LAN and no WAN, and discuss what users and network administrators gain and give up when migrating to the agile world of clo...
Agile, which started in the development organization, has gradually expanded into other areas downstream - namely IT and Operations. Teams – then teams of teams – have streamlined processes, improved feedback loops and driven a much faster pace into IT departments which have had profound effects on the entire organization. In his session at DevOps Summit, Anders Wallgren, Chief Technology Officer of Electric Cloud, will discuss how DevOps and Continuous Delivery have emerged to help connect dev...
WebRTC converts the entire network into a ubiquitous communications cloud thereby connecting anytime, anywhere through any point. In his session at WebRTC Summit,, Mark Castleman, EIR at Bell Labs and Head of Future X Labs, will discuss how the transformational nature of communications is achieved through the democratizing force of WebRTC. WebRTC is doing for voice what HTML did for web content.
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists addressed this very serious issue of pro...
"A lot of the enterprises that have been using our systems for many years are reaching out to the cloud - the public cloud, the private cloud and hybrid," stated Reuven Harrison, CTO and Co-Founder of Tufin, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
"We got started as search consultants. On the services side of the business we have help organizations save time and save money when they hit issues that everyone more or less hits when their data grows," noted Otis Gospodnetić, Founder of Sematext, in this SYS-CON.tv interview at @DevOpsSummit, held June 9-11, 2015, at the Javits Center in New York City.