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
(firmenpresse) - LYON, FRANCE -- (Marketwired) -- 03/10/16 -- Flamel Technologies (NASDAQ: FLML) today announced its financial results for the fourth quarter and full year of 2015.
Total revenue for fourth quarter 2015 was $43.4 million, compared to $3.0 million during the same period last year.
GAAP net income for the fourth quarter was $76.1 million, or $1.75 per diluted share, compared to a GAAP net loss of ($27.1) million, or ($0.69) per diluted share, for the same period last year.
Adjusted net income for the fourth quarter 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.
Cash and marketable securities at December 31, 2015 were $144.8 million, compared to $128.4 million at September 30, 2015 and $92.8 million at December 31, 2014.
Acquisition of FSC Pediatrics in February 2016 provides four new commercial stage products and established commercial infrastructure.
* Non-GAAP financial measure. Descriptions of Flamel''s non-GAAP financial measures are included under the caption "Non-GAAP Disclosures and Adjustments" included within this document and reconciliations of such non-GAAP financial measures to their most closely applicable GAAP financial measures are found in the "Supplemental Information" section within this document under the caption "Reconciliations of Non-GAAP Financial Measures."
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 Éclat #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 Éclat #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."
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.
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.
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, . The archived webcast of the conference call will be available for 90 days on Flamel''s website.
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 .
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 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 20-F for the year ended December 31, 2014, 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.
Flamel discloses certain non-GAAP financial measures, including adjusted net income and loss and adjusted net income and loss per diluted share, 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 results that exclude, if any, fair value remeasurements of its contingent consideration, impairment of intangible assets, amortization of intangible assets, effects of accelerated reimbursement of certain debt instruments, unrealized foreign exchange gains and losses on assets and liabilities denominated in foreign currency, the net income (loss) from discontinued operations and related tax effects, but includes the operating cash flows plus any unpaid accrued amounts associated with the contingent consideration, 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. The table provided within the following "Supplemental Information" section reconciles GAAP net income and loss and diluted earnings or loss per share to the corresponding adjusted amounts.
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Datum: 10.03.2016 - 07:00 Uhr
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