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
WebRTC has had a real tough three or four years, and so have those working with it. Only a few short years ago, the development world were excited about WebRTC and proclaiming how awesome it was. You might have played with the technology a couple of years ago, only to find the extra infrastructure requirements were painful to implement and poorly documented. This probably left a bitter taste in your mouth, especially when things went wrong.
Skeuomorphism usually means retaining existing design cues in something new that doesn’t actually need them. However, the concept of skeuomorphism can be thought of as relating more broadly to applying existing patterns to new technologies that, in fact, cry out for new approaches. In his session at DevOps Summit, Gordon Haff, Senior Cloud Strategy Marketing and Evangelism Manager at Red Hat, discussed why containers should be paired with new architectural practices such as microservices rathe...
SYS-CON Events announced today that G2G3 will exhibit at SYS-CON's @DevOpsSummit Silicon Valley, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Based on a collective appreciation for user experience, design, and technology, G2G3 is uniquely qualified and motivated to redefine how organizations and people engage in an increasingly digital world.
Any Ops team trying to support a company in today’s cloud-connected world knows that a new way of thinking is required – one just as dramatic than the shift from Ops to DevOps. The diversity of modern operations requires teams to focus their impact on breadth vs. depth. In his session at DevOps Summit, Adam Serediuk, Director of Operations at xMatters, Inc., will discuss the strategic requirements of evolving from Ops to DevOps, and why modern Operations has begun leveraging the “NoOps” approa...
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Organizations from small to large are increasingly adopting cloud solutions to deliver essential business services at a much lower cost. According to cyber security experts, the frequency and severity of cyber-attacks are on the rise, causing alarm to businesses and customers across a variety of industries. To defend against exploits like these, a company must adopt a comprehensive security defense strategy that is designed for their business. In 2015, organizations such as United Airlines, Sony...
The Internet of Things is in the early stages of mainstream deployment but it promises to unlock value and rapidly transform how organizations manage, operationalize, and monetize their assets. IoT is a complex structure of hardware, sensors, applications, analytics and devices that need to be able to communicate geographically and across all functions. Once the data is collected from numerous endpoints, the challenge then becomes converting it into actionable insight.
Puppet Labs has announced the next major update to its flagship product: Puppet Enterprise 2015.2. This release includes new features providing DevOps teams with clarity, simplicity and additional management capabilities, including an all-new user interface, an interactive graph for visualizing infrastructure code, a new unified agent and broader infrastructure support.
Consumer IoT applications provide data about the user that just doesn’t exist in traditional PC or mobile web applications. This rich data, or “context,” enables the highly personalized consumer experiences that characterize many consumer IoT apps. This same data is also providing brands with unprecedented insight into how their connected products are being used, while, at the same time, powering highly targeted engagement and marketing opportunities. In his session at @ThingsExpo, Nathan Trel...
Amazon and Google have built software-defined data centers (SDDCs) that deliver massively scalable services with great efficiency. Yet, building SDDCs has proven to be a near impossibility for ‘normal’ companies without hyper-scale resources. In his session at 17th Cloud Expo, David Cauthron, founder and chief executive officer of Nimboxx, will discuss the evolution of virtualization (hardware, application, memory, storage) and how commodity / open source hyper converged infrastructure (HCI) so...
In their Live Hack” presentation at 17th Cloud Expo, Stephen Coty and Paul Fletcher, Chief Security Evangelists at Alert Logic, will provide the audience with a chance to see a live demonstration of the common tools cyber attackers use to attack cloud and traditional IT systems. This “Live Hack” uses open source attack tools that are free and available for download by anybody. Attendees will learn where to find and how to operate these tools for the purpose of testing their own IT infrastructu...
The web app is agile. The REST API is agile. The testing and planning are agile. But alas, data infrastructures certainly are not. Once an application matures, changing the shape or indexing scheme of data often forces at best a top down planning exercise and at worst includes schema changes that force downtime. The time has come for a new approach that fundamentally advances the agility of distributed data infrastructures. Come learn about a new solution to the problems faced by software organ...
With the Apple Watch making its way onto wrists all over the world, it’s only a matter of time before it becomes a staple in the workplace. In fact, Forrester reported that 68 percent of technology and business decision-makers characterize wearables as a top priority for 2015. Recognizing their business value early on, FinancialForce.com was the first to bring ERP to wearables, helping streamline communication across front and back office functions. In his session at @ThingsExpo, Kevin Roberts...
IBM’s Blue Box Cloud, powered by OpenStack, is now available in any of IBM’s globally integrated cloud data centers running SoftLayer infrastructure. Less than 90 days after its acquisition of Blue Box, IBM has integrated its Blue Box Cloud Dedicated private-cloud-as-a-service into its broader portfolio of OpenStack® based solutions. The announcement, made today at the OpenStack Silicon Valley event, further highlights IBM’s continued support to deliver OpenStack solutions across all cloud depl...
Red Hat is investing in Tesora, the number one contributor to OpenStack Trove Database as a Service (DBaaS) also ranked among the top 20 companies contributing to OpenStack overall. Tesora, the company bringing OpenStack Trove Database as a Service (DBaaS) to the enterprise, has announced that Red Hat and others have invested in the company as a part of Tesora's latest funding round. The funding agreement expands on the ongoing collaboration between Tesora and Red Hat, which dates back to Febr...