SOURCE: Flamel Technologies

Flamel Technologies

November 07, 2016 09:13 ET

CORRECTION - Flamel Technologies Reports Third Quarter 2016 Results

LYON, FRANCE--(Marketwired - Nov 7, 2016) - In the news release, "Flamel Technologies Reports Third Quarter 2016 Results" issued earlier today by Flamel Technologies (NASDAQ: FLML), we are advised by the company that the fourth bullet of the Third Quarter Highlights list should read "Adjusted net loss for the third quarter was $3.5 million, or $(0.08) per diluted share, compared to an adjusted net loss of $13.1 million, or $0.32 per diluted share, during the same period last year. *" rather than "Adjusted net loss for the third quarter was $3.5 million, or $(0.11) per diluted share, compared to an adjusted net loss of $13.1 million, or $0.32 per diluted share, during the same period last year. *" as originally issued.  Complete corrected text follows.

Flamel Technologies Reports Third Quarter 2016 Results

Total Revenues Were $32.1 Million; 2016 Revenue Guidance Increased to $133 to $143 Million; REST-ON Phase III Trial of Micropump Sodium Oxybate Initiated

LYON, FRANCE -- Nov 7, 2016 -- Flamel Technologies (NASDAQ: FLML) today announced its financial results for the third quarter 2016.

Third Quarter Highlights Include:

  • Total revenues for third quarter 2016 were $32.1 million, compared to $47.3 million during the same period last year. 

  • GAAP net loss for the third quarter was $22.3 million, or $(0.54) per diluted share, compared to GAAP net loss of $28.1 million, or $(0.69) per diluted share, during the same period last year.

  • Adjusted operating income was $2.5 million, compared to $24.4 million in the prior year.*

  • Adjusted net loss for the third quarter was $3.5 million, or $(0.08) per diluted share, compared to an adjusted net loss of $13.1 million, or $0.32 per diluted share, during the same period last year. *

  • Cash and marketable securities at September 30, 2016 were $149.7 million, compared to $154.9 million at June 30, 2016 and $144.8 million at December 31, 2015. 

  • Protocol for REST-ON Phase III trial of once-nightly Micropump sodium oxybate approved by the U.S. Food & Drug Administration (FDA) through a Special Protocol Assessment (SPA) and trial initiated in Europe and Canada.

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, "Our base business, consisting of Bloxiverz® (neostigmine methylsulfate), Vazculep® (phenylephrine hydrochloride) and Akovaz™ (ephedrine sulfate), remained strong during the third quarter with revenues coming in just above top line consensus. Although we were able to maintain strong share in the neostigmine market at about forty percent (40%) during the third quarter, the overall market volume slightly declined. This, in addition to a small loss in price, resulted in lower quarter over quarter sales of Bloxiverz, at $15.6 million for the quarter. The phenylephrine business remained stable with third quarter 2016 sales of $9.3 million, relatively in line with the previous quarter after adjusting for our change in revenue recognition. As expected in the third quarter, we launched Akovaz, the first FDA-approved ephedrine sulfate injection. Akovaz added $5.6 million in revenues, partially offsetting some weakness in the neostigmine market which, as we outlined at the beginning of the year, was expected with increased competition. I am very pleased with the on-time and successful launch of Akovaz as it once again demonstrates our ability to identify, develop and launch commercially viable pharmaceutical products. Given that we launched later in the quarter, we are off to a good start."

Mr. Anderson continued, "In addition to our solid base business, we were pleased to host our first investor and analyst day in September, at which we announced the initiation of our Phase III trial of once nightly sodium oxybate in Canada. We have since initiated sites in Europe and received SPA approval from the FDA, which has given us further confidence as we proceed with our trial. We look forward to providing more updates on trial progress as we begin to dose patients."

Third Quarter 2016 Results

The Company generated revenues during the third quarter 2016 of $32.1 million, compared to $47.3 million during the same period last year. On a GAAP basis, the Company recorded a net loss of $22.3 million during the third quarter 2016, or $(0.54) per diluted share, compared to a net loss of $28.1 million, or $(0.69) per diluted share, for the same period last year. Included in the net loss for the third quarter 2016 were $22.7 million of charges related to changes in the fair value of related party contingent consideration and related party payables. The Company recognized a foreign currency exchange loss of $1.1 million in the third quarter 2016, compared to a foreign currency exchange gain of $0.2 million the prior year quarter. Adjusted net loss for the third quarter was $3.5 million, or $(0.08) per diluted share, compared to an adjusted net income of $13.1 million, or $0.32 per diluted share, during the same period last year. The decline in adjusted net income and adjusted diluted EPS from the previous year was due to lower product sales resulting from increased competition for neostigmine and higher SG&A from increased headcount. Please see the Supplemental Information section within this document for a reconciliation of adjusted net income and adjusted diluted EPS to the respective GAAP amounts. 

For the nine months ended September 30, 2016, cash flow from operations was $11.2 million, compared to $58.0 million in the same period last year. Cash and marketable securities at September 30, 2016 were $149.7 million, compared to $154.9 million at June 30, 2016.

2016 Guidance

As a result of the stable market to date for both Bloxiverz and Vazculep, in addition to a strong market for Akovaz, the Company is increasing its full year 2016 revenue guidance to the range of $133 to $143 million from its previous guidance range of $125 to $140 million. The Company expects to allocate a substantial amount of its R&D expenses to its REST-ON trial and is reiterating its full year 2016 guidance in the range of $30 to $40 million.

Conference Call

A conference call to discuss these results and other updates is scheduled for 10:00 a.m. ET on Monday, November 7, 2016. A question and answer period will follow management's prepared remarks. To participate in the conference call, investors are invited to dial 800-765-0709 (U.S. and Canada) or 913-312-0726 (international). The conference ID number is 9865797. A live audio webcast and accompanying slides can be accessed by visiting the Events & Presentations page of the Company's Investor website at http://www.flamel.com/investors. A replay of the webcast will be archived on Flamel's website for 90 days following the event.

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 three branded, sterile injectable products in the United States, Bloxiverz® (neostigmine methylsulfate injection), Vazculep® (phenylephrine hydrochloride injection), and Akovaz™ (ephedrine sulfate injection). 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. Applications of Flamel's drug delivery products include sodium oxybate (Micropump®), currently being studied in a Phase III trial to assess the safety and efficacy of a once nightly dose for treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy, and extended-release of liquid medicines (LiquiTime®) through a license arrangement with Elan Pharma International Limited for the U.S. Over-the-Counter market. Additionally, the Company's Trigger Lock™ technology is currently being studied with hydromorphone, and several proof of concept studies of exenatide utilizing the Medusa™ technology were completed in 2016. In February 2016, Flamel acquired FSC Pediatrics, a company that markets three pediatric pharmaceutical products - Cefaclor for oral suspension, Karbinal™ ER, and AcipHex® Sprinkle™ (rabeprazole sodium). FSC also received 510(k) clearance from the FDA in October 2014 for Flexichamber™, a collapsible holding chamber 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 St. Louis, Missouri. 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 and loss 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.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF LOSS
(In thousands, except per share data)
 
    Three Months Ended September 30,   Nine Months Ended September 30,
    2016   2015   2016   2015
                                 
Revenues:                                
  Product sales and services   $ 31,340     $ 47,313     $ 104,858     $ 128,441  
  License and research revenue     747       --       2,303       --  
Total     32,087       47,313       107,161       128,441  
Operating expenses:                                
  Cost of products and services sold     2,844       2,087       10,657       8,473  
  Research and development expenses     8,143       7,221       21,135       20,447  
  Selling, general and administrative expenses     12,740       4,568       33,491       14,904  
  Intangible asset amortization     3,702       3,141       10,918       9,423  
  Changes in fair value of related party contingent consideration     20,848       44,782       52,989       82,036  
Total     48,277       61,799       129,190       135,283  
Operating loss     (16,190 )     (14,486 )     (22,029 )     (6,842 )
  Investment income, net     490       197       1,080       1,171  
  Interest expense, net     (264 )     --       (702 )     --  
  Other expense - changes in fair value of related party payable     (1,828 )     (6,644 )     (6,135 )     (9,629 )
  Foreign exchange gain (loss)     (1,054 )     160       (2,315 )     8,096  
Loss before income taxes     (18,846 )     (20,773 )     (30,101 )     (7,204 )
  Income tax provision     3,451       7,302       18,212       24,516  
Net loss   $ (22,297 )   $ (28,075 )   $ (48,313 )   $ (31,720 )
                                 
Net loss per share - basic   $ (0.54 )   $ (0.69 )   $ (1.17 )   $ (0.79 )
Net loss per share - diluted   $ (0.54 )   $ (0.69 )   $ (1.17 )   $ (0.79 )
                                 
Weighted average number of shares outstanding - basic     41,241       40,625       41,241       40,397  
Weighted average number of shares outstanding - diluted     41,241       40,625       41,241       40,397  
                                 
FLAMEL TECHNOLOGIES S.A.
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)
 
    September 30, 2016   December 31, 2015
                 
ASSETS                
  Current assets:                
    Cash and cash equivalents   $ 18,780     $ 65,064  
    Marketable securities     130,887       79,738  
    Accounts receivable     15,395       7,487  
    Inventories     3,909       3,666  
    Research and development tax credit receivable     --       2,382  
    Prepaid expenses and other current assets     8,883       8,064  
  Total current assets     177,854       166,401  
  Property and equipment, net     3,186       2,616  
  Goodwill     19,134       18,491  
  Intangible assets, net     25,508       15,825  
  Research and development tax credit receivable     4,240       --  
  Income tax deferred charge     11,243       11,581  
  Other     6,820       167  
Total assets   $ 247,985     $ 215,081  
                 
LIABILITIES AND SHAREHOLDERS' EQUITY                
  Current liabilities:                
      Current portion of long-term debt   $ 286     $ 434  
      Current portion of long-term related party payable     33,359       25,204  
      Accounts payable     8,966       5,048  
      Deferred revenue     3,115       5,121  
      Accrued expenses     13,032       9,308  
    Other     427       133  
  Total current liabilities     59,185       45,248  
  Long-term debt, less current portion     734       684  
  Long-term related party payable, less current portion     146,926       97,489  
  Other     4,307       2,526  
  Total liabilities     211,152       145,947  
                   
  Shareholders' equity:                
    Ordinary shares, nominal value of 0.122 euro per share; 53,178 shares authorized; 41,241 issued and outstanding at September 30, 2016 and December 31, 2015     6,331       6,331  
    Additional paid-in capital     374,724       363,984  
    Accumulated deficit     (326,837 )     (278,524 )
    Accumulated other comprehensive loss     (17,385 )     (22,657 )
  Total shareholders' equity     36,833       69,134  
Total liabilities and shareholders' equity   $ 247,985     $ 215,081  
                 
FLAMEL TECHNOLOGIES S.A.
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
 
    Nine Months Ended September 30,
    2016   2015
                 
Cash flows from operating activities:                
  Net loss   $ (48,313 )   $ (31,718 )
  Adjustments to reconcile net loss to net cash provided by operating activities:                
    Depreciation and amortization     11,555       9,800  
    Loss on disposal of property and equipment     110       --  
    Loss on sale of marketable securities     666       635  
    Unrealized exchange loss (gain)     2,315       (7,248 )
    Grants recognized in research and development expenses     (70 )     (1,086 )
    Remeasurement of related party acquisition-related contingent consideration     52,989       82,036  
    Remeasurement of related party financing-related contingent consideration     6,135       9,628  
    Change in deferred tax and income tax deferred charge     (5,680 )     (714 )
    Stock-based compensation expense     10,541       5,485  
  Increase (decrease) in cash from:                
    Accounts receivable     (7,594 )     (1,553 )
    Inventories     2,080       1,543  
    Prepaid expenses and other current assets     671       (4,293 )
    Research and development tax credit receivable     (1,794 )     2,481  
    Accounts payable & other current liabilities     1,291       (4,231 )
    Deferred revenue     (2,198 )     (1,317 )
    Accrued expenses     2,700       (1,094 )
    Accrued income taxes     --       (490 )
    Earn-out payments for related party contingent consideration in excess of acquisition-date fair value     (14,488 )     --  
    Royalty payments for related party payable in excess of original fair value     (1,790 )     --  
    Other long-term assets and liabilities     2,033       131  
Net cash provided by operating activities     11,159       57,995  
Cash flows from investing activities:                
  Purchases of property and equipment     (1,000 )     (1,065 )
  Acquisitions of businesses     628       --  
  Proceeds from sales of marketable securities     46,483       23,995  
  Purchase of marketable securities     (96,199 )     (36,210 )
Net cash used in investing activities     (50,088 )     (13,280 )
Cash flows from financing activities:                
  Earn-out payments for related party contingent consideration     (6,834 )     (15,497 )
  Royalty payments for related party payable     (1,117 )     (2,099 )
  Repayment of debt     --       (4,965 )
  Reimbursement of conditional grants     (61 )     (681 )
  Cash proceeds from issuance of ordinary shares and warrants     --       6,990  
Net cash used in financing activities     (8,012 )     (16,252 )
Effect of exchange rate changes on cash and cash equivalents     657       (2,358 )
Net increase (decrease) in cash and cash equivalents     (46,284 )     26,105  
Cash and cash equivalents at January 1     65,064       39,760  
Cash and cash equivalents at September 30   $ 18,780     $ 65,865  
                 
FLAMEL TECHNOLOGIES S.A.
UNAUDITED SUPPLEMENTAL INFORMATION
(In thousands, except per share data)
 
    Three Months Ended September 30,   Nine Months Ended September 30,
Revenues   2016   2015   2016   2015
                         
  Bloxiverz   $ 15,591   $ 41,243   $ 65,958   $ 114,074
  Vazculep     9,340     5,605     29,167     12,757
  Akovaz     5,568     --     5,568     --
  Other     841     465     4,165     1,610
Total product sales and services     31,340     47,313     104,858     128,441
  License and research revenue     747     --     2,303     --
Total revenues   $ 32,087   $ 47,313   $ 107,161   $ 128,441
                         
                 
        Adjustments for the three months ended, September 30, 2016        
        Exclude   Include        
    GAAP   Intangible asset amortization   Foreign exchange (gain)/loss   Contingent related party payable fair value remeasurements   Contingent related party payable paid/accrued   Total adjustments   Adjusted GAAP
                                                       
Revenues:                                                      
  Product sales and services   $ 31,340     $ --     $ --   $ --     $ --     $ --     $ 31,340  
  License and research revenue     747       --       --     --       --       --       747  
Total     32,087       --       --     --       --       --       32,087  
Operating expenses:                                                      
  Cost of products and services sold     2,844       --       --     --       --       --       2,844  
  Research and development expenses     8,143       --       --     --       --       --       8,143  
  Selling, general and administrative expenses     12,740       --       --     --       --       --       12,740  
  Intangible asset amortization     3,702       (3,702 )     --     --       --       (3,702 )     --  
  Changes in fair value of related party contingent consideration     20,848       --       --     (20,848 )     5,884       (14,964 )     5,884  
Total     48,277       (3,702 )     --     (20,848 )     5,884       (18,666 )     29,611  
Operating (loss) income     (16,190 )     3,702       --     20,848       (5,884 )     18,666       2,476  
  Investment income, net     490       --       --     --       --       --       490  
  Interest expense, net     (264 )     --       --     --       --       --       (264 )
  Other expense - changes in fair value of related party payable     (1,828 )     --       --     1,828       (785 )     1,043       (785 )
  Foreign exchange gain (loss)     (1,054 )     --       1,054     --       --       1,054       --  
(Loss) income before income taxes     (18,846 )     3,702       1,054     22,676       (6,669 )     20,763       1,917  
  Income tax provision (benefit)     3,451       1,329       --     1,021       (385 )     1,965       5,416  
Net (loss) income   $ (22,297 )   $ 2,373     $ 1,054   $ 21,655     $ (6,284 )   $ 18,798     $ (3,499 )
                                                       
Net (loss) income per share - diluted   $ (0.54 )     0.06       0.03     0.53       (0.15 )     0.46       (0.08 )
                                                       
Weighted average number of shares outstanding - diluted     41,241       41,241       41,241     41,241       41,241       41,241       41,241  
                                                       
                 
        Adjustments for the three months ended, September 30, 2015        
        Exclude   Include        
    GAAP   Intangible asset amortization   Foreign exchange (gain)/loss   Contingent related party payable fair value remeasurements   Contingent related party payable paid/accrued   Total adjustments   Adjusted GAAP
                                                         
Revenues:                                                        
  Product sales and services   $ 47,313     $ --     $ --     $ --     $ --     $ --     $ 47,313  
  License and research revenue     --       --       --       --       --       --       --  
Total     47,313       --       --       --       --       --       47,313  
Operating expenses:                                                        
  Cost of products and services sold     2,087       --       --       --       --       --       2,087  
  Research and development expenses     7,221       --       --       --       --       --       7,221  
  Selling, general and administrative expenses     4,568       --       --       --       --       --       4,568  
  Intangible asset amortization     3,141       (3,141 )     --       --       --       (3,141 )     --  
  Changes in fair value of related party contingent consideration     44,782       --       --       (44,782 )     9,027       (35,755 )     9,027  
Total     61,799       (3,141 )     --       (44,782 )     9,027       (38,896 )     22,903  
Operating (loss) income     (14,486 )     3,141       --       44,782       (9,027 )     38,896       24,410  
  Investment income, net     197       --       --       --       --       --       197  
  Interest expense, net     --       --       --       --       --       --       --  
  Other expense - changes in fair value of related party payable     (6,644 )     --       --       6,644       (1,211 )     5,433       (1,211 )
  Foreign exchange gain (loss)     160       --       (160 )     --       --       (160 )     --  
(Loss) income before income taxes     (20,773 )     3,141       (160 )     51,426       (10,238 )     44,169       23,396  
  Income tax provision (benefit)     7,302       1,099       (48 )     2,325       (424 )     2,952       10,254  
Net (loss) income   $ (28,075 )   $ 2,042     $ (112 )   $ 49,101     $ (9,814 )   $ 41,217     $ 13,142  
                                                         
Net (loss) income per share - diluted   $ (0.69 )   $ 0.05     $ --     $ 1.21     $ (0.24 )   $ 1.01     $ 0.32  
                                                         
Weighted average number of shares outstanding - diluted     40,625       40,625       40,625       40,625       40,625       40,625       40,625  
                                                         
        Adjustments for the nine months ended, September 30, 2016        
        Exclude   Include        
    GAAP   Intangible asset amortization   Foreign exchange (gain)/loss   Purchase accounting adjustments - FSC   Contingent related party payable fair value remeasurements   Contingent related party payable paid/accrued   Total adjustments   Adjusted GAAP
                                                               
Revenues:                                                              
  Product sales and services   $ 104,858     $ --     $ --   $ --     $ --     $ --     $ --     $ 104,858  
  License and research revenue     2,303       --       --     --       --       --       --       2,303  
Total     107,161       --       --     --       --       --       --       107,161  
Operating expenses:                                                              
  Cost of products and services sold     10,657       --       --     (1,525 )     --       --       (1,525 )     9,132  
  Research and development expenses     21,135       --       --     --       --       --       --       21,135  
  Selling, general and administrative expenses     33,491       --       --     --       --       --       --       33,491  
  Intangible asset amortization     10,918       (10,918 )     --     --       --       --       (10,918 )     --  
  Changes in fair value of related party contingent consideration     52,989       --       --     --       (52,989 )     19,321       (33,668 )     19,321  
Total     129,190       (10,918 )     --     (1,525 )     (52,989 )     19,321       (46,111 )     83,079  
Operating (loss) income     (22,029 )     10,918       --     1,525       52,989       (19,321 )     46,111       24,082  
  Investment income, net     1,080       --       --     --       --       --       --       1,080  
  Interest expense, net     (702 )     --       --     --       --       --       --       (702 )
  Other expense - changes in fair value of related party payable     (6,135 )     --       --     --       6,135       (2,618 )     3,517       (2,618 )
  Foreign exchange gain (loss)     (2,315 )     --       2,315     --       --       --       2,315       --  
(Loss) income before income taxes     (30,101 )     10,918       2,315     1,525       59,124       (21,939 )     51,943       21,842  
  Income tax provision (benefit)     18,212       3,920       --     533       2,986       (1,165 )     6,274       24,486  
Net (loss) income   $ (48,313 )   $ 6,998     $ 2,315   $ 992     $ 56,138     $ (20,774 )   $ 45,669     $ (2,644 )
                                                               
Net (loss) income per share - diluted   $ (1.17 )   $ 0.17     $ 0.06   $ 0.02     $ 1.36     $ (0.50 )   $ 1.11     $ (0.06 )
                                                               
Weighted average number of shares outstanding - diluted     41,241       41,241       41,241     41,241       41,241       41,241       41,241       41,241  
                                                               
                 
        Adjustments for the nine months ended, September 30, 2015        
        Exclude   Include        
    GAAP   Intangible asset amortization   Foreign exchange (gain)/loss   Contingent related party payable fair value remeasurements   Contingent related party payable paid/accrued   Total adjustments   Adjusted GAAP
                                                         
Revenues:                                                        
  Product sales and services   $ 128,441     $ --     $ --     $ --     $ --     $ --     $ 128,441  
  License and research revenue     --       --       --       --       --       --       --  
Total     128,441       --       --       --       --       --       128,441  
Operating expenses:                                                        
  Cost of products and services sold     8,473       --       --       --       --       --       8,473  
  Research and development expenses     20,447       --       --       --       --       --       20,447  
  Selling, general and administrative expenses     14,904       --       --       --       --       --       14,904  
  Intangible asset amortization     9,423       (9,423 )     --       --       --       (9,423 )     --  
  Changes in fair value of related party contingent consideration     82,036       --       --       (82,036 )     23,923       (58,113 )     23,923  
Total     135,283       (9,423 )     --       (82,036 )     23,923       (67,536 )     67,747  
Operating (loss) income     (6,842 )     9,423       --       82,036       (23,923 )     67,536       60,694  
  Investment income, net     1,171       --       --       --       --       --       1,171  
  Interest expense, net     --       --       --       --       --       --       --  
  Other expense - changes in fair value of related party payable     (9,629 )     --       --       9,629       (3,291 )     6,338       (3,291 )
  Foreign exchange gain (loss)     8,096       --       (8,096 )     --       --       (8,096 )     --  
(Loss) income before income taxes     (7,204 )     9,423       (8,096 )     91,665       (27,214 )     65,778       58,574  
  Income tax provision (benefit)     24,516       3,298       (2,429 )     3,370       (1,152 )     3,087       27,603  
Net (loss) income   $ (31,720 )   $ 6,125     $ (5,667 )   $ 88,295     $ (26,062 )   $ 62,691     $ 30,971  
                                                         
Net (loss) income per share - diluted   $ (0.79 )   $ 0.15     $ (0.14 )   $ 2.19     $ (0.65 )   $ 1.55     $ 0.77  
                                                         
Weighted average number of shares outstanding - diluted     40,397       40,397       40,397       40,397       40,397       40,397       40,397