SOURCE: Flamel Technologies

Flamel Technologies

May 09, 2016 07:30 ET

Flamel Technologies Reports First Quarter 2016 Results

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 Million

LYON, FRANCE--(Marketwired - May 9, 2016) - Flamel Technologies (NASDAQ: FLML) today announced its financial results for the first quarter of 2016.

First Quarter Highlights Include:

  • Total revenue for first quarter 2016 was $36.2 million, compared to $32.7 million during the same period last year.
  • GAAP net loss for the first quarter was ($6.4) million, or ($0.15) per diluted share, compared to GAAP net income of $11.6 million, or $0.27 per diluted share during the same period last year. 
  • Adjusted EBITDA was $11.8 million, compared to $12.9 million in the prior 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. *
  • Cash and marketable securities at March 31, 2016 were $160.0 million, compared to $144.8 million at December 31, 2015 and $113.2 million at March 31, 2015. 
  • Special Protocol Assessment (SPA) submitted to the U.S. Food and Drug Administration (FDA) for the once nightly version of Micropump® sodium oxybate.

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.  

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
The 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 Éclat 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.

Conference Call
A conference 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 Akovazproducts, 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 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, 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.

 
 
Flamel Technologies S.A.
Consolidated Statements of Income (Loss) - (Unaudited)
(In Thousands, Except Per Share Data)
 
    Three Months Ended
    March 31,
    2016   2015
Revenues:            
  Product sales and services   $ 35,353   $ 32,726
  License and research revenue     863     -
  Total     36,216     32,726
Operating expenses:            
  Cost of products and services sold     4,395     3,630
  Research and development expenses     5,388     6,022
  Selling, general and administrative expenses     9,461     4,463
  Intangible asset amortization     3,514     3,143
  Changes in fair value of related party acquisition-related contingent consideration     7,916     5,254
  Total     30,674     22,512
Operating income     5,542     10,214
  Investment Income     200     664
  Interest Expense     (175)     -
  Interest Expense - changes in fair value of related party financing-related contingent consideration     (1,861)     (259)
  Foreign exchange gain (loss)     (2,941)     11,501
Income before income taxes     765     22,120
  Income tax provision     7,141     10,473
Net income (loss)   $ (6,376)   $ 11,647
             
Net income (loss) per share - Basic   $ (0.15)   $ 0.29
Net income (loss) per share - Diluted   $ (0.15)   $ 0.27
             
Weighted average number of shares outstanding - Basic     41,241     40,207
Weighted average number of shares outstanding - Diluted     41,241     42,879
   
   
Flamel Technologies S.A.  
Consolidated Balance Sheets - (Unaudited)  
(In Thousands, Except Per Share Data)  
   
    March 31,     December 31,  
    2016     2015  
ASSETS                
  Current assets:                
    Cash and cash equivalents   $ 37,870     $ 65,064  
    Marketable securities     122,084       79,738  
    Accounts receivable (net of allowance of $35 at both March 31, 2016 and December 31, 2015)     4,865       6,978  
    Inventories     5,312       4,155  
    Research and development tax credit receivable - current portion     368       2,382  
    Prepaid expenses and other current assets     9,975       7,989  
  Total current assets     180,474       166,306  
  Property and equipment, net     3,100       2,616  
  Goodwill     24,055       18,491  
  Intangible assets, net     32,911       15,825  
  Research and Development tax credit receivable less current portion     2,490       -  
  Income tax deferred charge     11,964       11,581  
  Other     16       158  
Total assets   $ 255,010     $ 214,977  
                 
LIABILITIES AND SHAREHOLDERS' EQUITY                
  Current liabilities:                
    Current portion of long-term debt   $ 454     $ 434  
    Current portion of long-term related party contingent consideration payable     28,403       28,614  
    Accounts payable     17,674       10,565  
    Deferred revenue     4,611       5,121  
    Accrued expenses     3,346       3,598  
    Income taxes     5,844       323  
    Other     611       133  
  Total current liabilities     60,943       48,788  
  Long-term debt, less current portion     710       684  
  Long-term related party contingent consideration payable, less current portion     102,656       94,079  
  Long-term related party payable     15,000       -  
  Deferred taxes     3,507       1,351  
  Other     2,495       2,210  
  Total liabilities     185,311       147,112  
                 
  Shareholders' equity:                
    Ordinary shares, nominal value of 0.122 euro per share; 53,178 shares authorized; 41,241 issued and outstanding at March 31, 2016 and December 31, 2015, respectively     6,331       6,331  
    Additional paid-in capital     366,459       363,984  
    Accumulated deficit     (286,169 )     (279,793 )
    Accumulated other comprehensive loss     (16,922 )     (22,657 )
  Total shareholders' equity     69,699       67,865  
Total liabilities and shareholders' equity   $ 255,010     $ 214,977  
   
   
Flamel Technologies S.A.  
Consolidated Statements of Cash Flows - (Unaudited)  
(In Thousands)  
   
    Three Months Ended  
    March 31,  
    2016     2015  
Cash flows from operating activities:                
  Net income (loss)   $ (6,376 )   $ 11,647  
  Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:                
    Depreciation and amortization     3,754       3,260  
    Loss on disposal of property and equipment     102       -  
    Loss (gain) on sale of marketable securities     285       (489 )
    Unrealized exchange loss (gain)     2,941       (11,296 )
    Remeasurement of related party acquisition-related contingent consideration     7,916       5,254  
    Remeasurement of related party financing-related contingent consideration     1,861       259  
    Change in deferred tax and income tax deferred charge     (1,682 )     5,864  
    Stock-based compensation expense     2,475       1,593  
  Increase (decrease) in cash from:                
    Accounts receivable     2,120       1,376  
    Inventories     1,212       1,207  
    Prepaid expenses and other current assets     (206 )     (368 )
    Research and development tax credit receivable     (363 )     (127 )
    Accounts payable & other current liabilities     4,029       2,295  
    Deferred revenue     (758 )     2,177  
    Accrued expenses     (809 )     (858 )
    Accrued income taxes     5,520       3,283  
    Other long-term assets and liabilities     477       198  
Net cash provided by operating activities     22,498       25,275  
                 
Cash flows from investing activities:                
  Purchases of property and equipment     (460 )     (234 )
  Proceeds from disposal of property and equipment     161       -  
  Proceeds from sales of marketable securities     9,766       2,817  
  Purchase of marketable securities     (50,454 )     (26,012 )
Net cash used in investing activities     (40,987 )     (23,429 )
                 
Cash flows from financing activities:                
  Earn-out payments for related party acquisition-related contingent consideration     (8,014 )     (325 )
  Royalty payments for related party financing-related contingent consideration     (1,092 )     -  
  Cash proceeds from issuance of ordinary shares and warrants     -       246  
Net cash used in financing activities     (9,106 )     (79 )
                 
Effect of exchange rate changes on cash and cash equivalents     401       (2,992 )
                 
Net decrease in cash and cash equivalents     (27,194 )     (1,225 )
Cash and cash equivalents at January 1     65,064       39,760  
Cash and cash equivalents at March 31   $ 37,870     $ 38,535  
                 
Free Cash Flow     12,932       24,716  
   
   
Flamel Technologies S.A.  
Supplemental Information - (Unaudited)  
(In Thousands, Except Per Share Data)  
    Three Months Ended  
    March 31,  
    2016     2015  
                 
Revenue by product:                
    Bloxiverz   $ 24,747     $ 28,642  
    Vazculep     9,406       3,524  
    Other     1,200       560  
    Total product sales and services     35,353       32,726  
    License and research revenue     863       -  
    Total revenues   $ 36,216     $ 32,726  
                 
                 
Reconciliation of Reported to Adjusted Financial Statement Line Items:                
                 
  Operating Income and EBITDA:                
                 
    Reported Operating Income   $ 5,542     $ 10,214  
                 
    Exclude: Contingent consideration - Acquisition-related fair value remeasurements - Inc./(Dec.)     7,916       5,254  
      Intangible asset amortization     3,514       3,143  
      Purchase accounting adjustments - FSC     763       -  
                 
    Include: Contingent consideration - Acquisition-related paid/accrued     (6,217 )     (5,796 )
                 
    Total adjustments     5,976       2,601  
                 
    Adjusted Operating Income   $ 11,518     $ 12,815  
                 
    Exclude: Depreciation Expense     240       117  
                 
    Adjusted EBITDA   $ 11,758     $ 12,932  
                 
Net income (loss)                
                 
    Reported   $ (6,376 )   $ 11,647  
                 
    Exclude: Contingent consideration - Acquisition-related fair value remeasurements - Inc./(Dec.)     7,916       5,254  
      Contingent consideration - Financing-related fair value remeasurements - Inc./(Dec.)     1,861       259  
      Intangible asset amortization     3,514       3,143  
      Purchase accounting adjustments - FSC     763       -  
      Foreign exchange (gain)/loss     2,941       (11,501 )
                 
    Include: Contingent consideration - Acquisition-related paid/accrued     (6,217 )     (5,796 )
      Contingent consideration - Financing-related paid/accrued     (1,023 )     (845 )
                 
    Income tax expense (benefit) related to all above adjustments     (1,829 )     2,555  
                 
    Total adjustments     7,926       (6,931 )
                 
    Adjusted   $ 1,550     $ 4,716  
                 
Net income (loss) per share - Diluted                
                 
    Reported   $ (0.15 )   $ 0.27  
                 
    Exclude: Contingent consideration - Acquisition-related fair value remeasurements - Inc./(Dec.)     0.17       0.13  
      Contingent consideration - Financing-related fair value remeasurements - Inc./(Dec.)     0.05       0.01  
      Intangible asset amortization     0.09       0.07  
      Purchase accounting adjustments - FSC     0.02       -  
      Foreign exchange (gain)/loss     0.07       (0.27 )
                 
    Include: Contingent consideration - Acquisition-related paid/accrued     (0.15 )     (0.14 )
      Contingent consideration - Financing-related paid/accrued     (0.02 )     (0.02 )
                 
    Income tax expense (benefit) related to all above adjustments     (0.04 )     0.06  
                 
    Total adjustments     0.19       (0.16 )
                 
    Adjusted   $ 0.04     $ 0.11  
                 
Free Cash Flow                
                 
    Net cash provided by operating activities   $ 22,498     $ 25,275  
                 
    Less: Purchases of property and equipment     (460 )     (234 )
      Contingent consideration - Acquisition-related payments     (8,014 )     (325 )
      Contingent consideration - Financing-related payments     (1,092 )     -  
                 
    Free Cash Flow   $ 12,932     $ 24,716