DUBLIN, Ireland, Nov. 05, 2018 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on providing innovative medicines for chronic urological, central nervous system, and sleep disorders, today announced its financial results for the third quarter of 2018.

Mike Anderson, Avadel’s Chief Executive Officer, said, “We executed a number of important initiatives during the third quarter related to our REST-ON Phase 3 FT 218 clinical study in narcolepsy and our recently launched product, NOCTIVA™. For REST-ON, we completed 10 new clinical site initiations, hosted two successful patient events with well over 100 attendees, and recently launched a patient referral program in tandem with a new ad campaign, all of which have opened us up to new pools of potential patients."

"While prescription uptake for NOCTIVA is a bit slower than we anticipated, a number of important metrics have continued to improve over the last 3 months. We have substantially grown our prescriber base and have seen triple the number of prescriptions since the start of August, resulting in almost 8,000 dispensed prescriptions to date from over 1,800 unique prescribers. Our unaided brand awareness increased to approximately 80 percent, up from just under 60 percent in August, and recent intent-to-treat data indicates that 85 percent of targeted physicians expect to increase use of NOCTIVA in the next 6 months. Although the level of financial assistance to ensure patient access continues to impact revenue, we improved coverage through commercial insurance plans during the quarter and now have almost 140 million lives with access to NOCTIVA. In addition, we secured our first Part D contract with a top 5 provider and believe as we further expand access and drive demand we will improve our top line results."

Overview of third quarter 2018 financial results:

Revenues by product:    
  Three Months Ended September 30,
($ in 000s) 2018 2017
     
Bloxiverz $3,656  $9,920 
Vazculep 8,759  9,573 
Akovaz 5,991  18,561 
Noctiva 1,047   
Other 373  1,093 
Product sales 19,826  39,147 
License revenue   528 
Total revenues $19,826  $39,675 
         

Revenues for the third quarter 2018 were $19.8 million, compared to $39.7 million in the third quarter 2017. The decline on a year-over-year basis was attributed to lower net selling prices across all of our hospital products and lower unit volumes for Akovaz® and Bloxiverz® as a result of increased market competition.  Net sales for NOCTIVA, which was launched in May 2018, were $1.0 million in the third quarter 2018, up from $0.3 million in the second quarter 2018.

Operating expenses:    
  Three Months Ended
September 30,
($ in 000s) 2018 2017
     
Cost of products $3,120  $3,790 
Research and development expenses (R&D) 11,402  8,095 
Selling, general and administrative expenses (SG&A) 24,829  11,563 
       

R&D expense was up $3.3 million in the third quarter 2018 compared to the prior year period, primarily due to increased spend on the Phase 3 REST-ON trial. The $13.3 million increase in SG&A in the third quarter 2018 compared to the third quarter 2017 was due to sales and marketing expenses associated with the May 2018 launch of NOCTIVA.

     
GAAP earnings (loss):    
  Three Months Ended
September 30,
($ in 000s except for per share) 2018 2017
     
Net (loss) income $(15,771) $21,679 
Net (loss) income per share - diluted (0.43) 0.52 
       

Included in GAAP net loss for the third quarter 2018 were gains of $7.1 million related to changes in the fair value of related party contingent consideration, compared to gains of $9.9 million in the same period last year. These non-cash gains were recorded as a result of reducing the fair value of related party contingent consideration due to changing market conditions across the Company's three hospital products. Additionally, included in GAAP net loss for the third quarter 2018 was $3.0 in interest expense related to the Company's convertible notes issued in February 2018.

     
Adjusted earnings (loss) (1):    
  Three Months Ended September 30,
($ in 000s except for per share) 2018 2017
     
Adjusted net (loss) income $(23,969) $3,747 
Adjusted net (loss) income per share - diluted (0.65) 0.09 
       

The decrease in adjusted net income is largely attributable to lower revenues from the Company’s hospital products, higher SG&A due to the 2018 launch of NOCTIVA and increased R&D spend on the Phase 3 REST-ON trial.  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.

__

(1)  Descriptions of Avadel’s non-GAAP financial measures are included under the caption Non-GAAP Disclosures and Adjustments included within this press release and reconciliations of such non-GAAP financial measures to their most closely applicable GAAP financial measures are found in the Supplemental Information section herein.

2018 Guidance:

The Company is maintaining its full-year 2018 revenue guidance of $90 to $105 million, and its full-year R&D spend guidance of $40 to $50 million.  SG&A is now expected to range between $85 to $95 million for the full year compared to $80 to $90 million in our previous guidance. Within the 2018 revenue guidance, the Company does not anticipate reaching the low end of its previous guidance for NOCTIVA of $5 million, due to a higher mix of Medicare Part D scripts, high levels of copay assistance, and lower overall script growth compared to the assumptions used for such previous guidance. Cash interest expense paid and accrued on the Company's convertible notes issued in February 2018 is expected to be approximately $6 million, and a non-GAAP tax benefit of 0% to 10% of loss before tax is anticipated for the full year 2018.

Conference Call:

A conference call to discuss these results has been scheduled for Monday, November 5, 2018 at 10:00 a.m. EST. A question and answer period will follow management's prepared remarks. To access the conference call, investors are invited to dial (844) 388-0559 (U.S. and Canada) or (216) 562-0393 (International). The conference ID number is 6799356. A live audio webcast can be accessed by visiting the investor relations section of the Company’s website, www.avadel.com. A replay of the webcast will be archived on Avadel’s website for 90 days following the event.

About Avadel Pharmaceuticals plc:

Avadel Pharmaceuticals plc (Nasdaq: AVDL) is a specialty pharmaceutical company that seeks to develop differentiated pharmaceutical products that are safe, effective and easy to take through formulation development, by utilizing its proprietary drug delivery technology and through in-licensing / acquiring new products; ultimately, helping patients adhere to their prescribed medical treatment and see better results. Avadel’s current portfolio of products and product candidates focuses on the urology, central nervous system (CNS) / sleep, and hospital markets. The Company is headquartered in Dublin, Ireland with operations in St. Louis, Missouri and Lyon, France. For more information, please visit www.avadel.com.

Safe Harbor: This press release may include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The words “will,” “may,” “believe,” “expect,” “anticipate,” “estimate,” “project,” "guidance" and similar expressions, and (as applicable) the negatives thereof, identify forward-looking statements, each of which speaks only as of the date the statement is made. Although we believe that our forward-looking statements are based on estimates and assumptions made within the bounds of our knowledge of our business and operations, our business and operations are subject to significant risks and as a result there can be no assurance that actual results of our research, development and commercialization activities and the results of our business and operations will not differ materially from the results contemplated in such forward-looking statements. These risks include: (i) risks relating to our exchangeable senior notes including use of the net proceeds from the offering of the notes and other future events related to the notes; (ii) risks relating to the divestiture of our former pediatric business including whether such divestiture will be accretive to our operating income and cash flow; (iii) risks relating to our license agreement with Serenity Pharmaceuticals, LLC including that a potential competitive product, and patent litigation with the manufacturer of that product, could have a material adverse impact on our ability to successfully exploit any market opportunity for the drug desmopressin acetate (the “Drug”) which we are marketing under the brand name NOCTIVAtm, our internal analyses may overstate the market opportunity in the United States for the Drug or we may not effectively exploit such market opportunity, that significant safety or drug interaction problems could arise with respect to the Drug, that we may not successfully increase awareness of nocturia and the potential benefits of the Drug, and that the need for management to focus attention on the development and commercialization of the Drug could cause our ongoing business operations to suffer; and (iv) 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, 2017, in particular disclosures therein that may be set forth under the captions “Forward-Looking Statements” and “Risk Factors,” including without limitation: our dependence on a small number of products and customers for the majority of our revenues; the possibility that our Bloxiverz®,Vazculep® and Akovaz® products, which are not patent protected, could continue to face substantial and increased competition resulting in a loss of market share and/or forcing us to further reduce the prices we charge for those products; the possibility that we could fail to successfully complete the research and development for 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; the possibility that we could experience failure or delay in completing the Phase 3 clinical trial for our “FT 218” sodium oxybate product known as REST-ON); 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; and our dependence on key personnel to execute our business plan.  Forward-looking statements are necessarily based on estimates and assumptions that, while considered reasonable by us and our management, are inherently uncertain. Accordingly, you should not place undue reliance on forward-looking statements, which speak only as of the date they are made, and are not guarantees of future performance. We do not undertake any obligation to publicly update or revise these forward-looking statements.

Non-GAAP Disclosures and Adjustments

In addition to reporting its financial results in accordance with generally accepted accounting principles in the U.S.("GAAP"), Avadel 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 such non-GAAP financial measures can enhance an overall understanding of the Company’s financial performance when considered together with financial measures prepared in accordance with GAAP.  The non-GAAP results disclosed herein (a) exclude, in each case to the extent applicable, fair value remeasurements of its contingent consideration, amortization of debt discount and debt issuance costs attributable to our  exchangeable notes, impairment of intangible assets, amortization of intangible assets, restructuring costs, foreign exchange gains and losses on assets and liabilities denominated in foreign currencies, unrealized gains/losses on marketable equity securities,  but (b) include the cash payments plus any unpaid accrued cash payments associated with the contingent consideration and cash interest payments or related accruals on the exchangeable notes. Our management uses these non-GAAP measures internally for forecasting, budgeting and measuring the Company's operating performance. Investors and other readers should review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most closely comparable 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 (i.e., "non-GAAP") amounts.


Contacts:Michael F. Kanan
 Chief Financial Officer
 Phone: (636) 449-1844
 Email: mkanan@avadel.com
  
 Lauren Stival
 Sr. Director, Investor Relations & Corporate Communications
 Phone: (636) 449-5866
 Email: lstival@avadel.com
  


AVADEL PHARMACEUTICALS PLC
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS)
(In thousands, except per share data)

  Three Months Ended September
30,
 Nine Months Ended September
30,
  2018 2017 2018 2017
         
Revenues:        
Product sales $19,826  $39,147  $82,103  $138,009 
License revenue   528  246  484 
Total revenues 19,826  39,675  82,349  138,493 
Operating expenses:        
Cost of products 3,120  3,790  13,224  12,253 
Research and development expenses 11,402  8,095  33,243  22,093 
Selling, general and administrative expenses 24,829  11,563  77,159  35,804 
Intangible asset amortization 1,620  564  4,996  1,692 
Gain - changes in fair value of related party contingent consideration (7,115) (9,906) (17,036) (30,107)
Restructuring costs 65  (549) 268  3,173 
Total operating expenses 33,921  13,557  111,854  44,908 
Operating (loss) income (14,095) 26,118  (29,505) 93,585 
Investment and other income, net 208  977  845  2,562 
Interest expense (3,000) (263) (7,577) (789)
Other income - changes in fair value of related party payable 425  768  1,432  2,988 
(Loss) income before income taxes (16,462) 27,600  (34,805) 98,346 
Income tax (benefit) provision (691) 5,921  (3,360) 21,830 
Net (loss) income $(15,771) $21,679  $(31,445) $76,516 
         
Net (loss) income per share - basic $(0.43) $0.54  $(0.84) $1.87 
Net (loss) income per share - diluted (0.43) 0.52  (0.84) 1.81 
         
Weighted average number of shares outstanding - basic 36,904  40,061  37,410  40,839 
Weighted average number of shares outstanding - diluted 36,904  41,339  37,410  42,194 
             



AVADEL PHARMACEUTICALS PLC
UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data)

  September 30, 2018 December 31, 2017
     
ASSETS    
Current assets:    
Cash and cash equivalents $17,837  $16,564 
Marketable securities 107,425  77,511 
Accounts receivable 9,725  14,785 
Inventories 6,030  6,157 
Prepaid expenses and other current assets 6,859  8,958 
Total current assets 147,876  123,975 
Property and equipment, net 2,288  3,001 
Goodwill 18,491  18,491 
Intangible assets, net 69,339  92,289 
Research and development tax credit receivable 6,168  5,272 
Other non-current assets 24,844  10,249 
Total assets $269,006  $253,277 
     
LIABILITIES AND SHAREHOLDERS’ EQUITY    
Current liabilities:    
Current portion of long-term debt $107  $111 
Current portion of long-term related party payable 10,979  25,007 
Accounts payable 11,399  7,477 
Deferred revenue 1,720  2,007 
Accrued expenses 20,698  50,926 
  Other current liabilities 2,116  1,011 
Total current liabilities 47,019  86,539 
Long-term debt, less current portion 114,382  156 
Long-term related party payable, less current portion 27,713  73,918 
Other non-current liabilities 14,150  7,084 
Total liabilities 203,264  167,697 
     
Shareholders’ equity:    
Preferred shares, $0.01 nominal value; 50,000 shares authorized at September 30, 2018 and December 31, 2017, respectively; none issued or outstanding at September 30, 2018 and December 31, 2017, respectively    
Ordinary shares, nominal value of $0.01; 500,000 shares authorized; 42,420 issued and 37,012 outstanding at September 30, 2018 and 41,463 issued and 39,346 outstanding at December 31, 2017 424  414 
Treasury shares, at cost, 5,408 and 2,117 shares held at September 30, 2018 and December 31, 2017, respectively (49,998) (22,361)
Additional paid-in capital 433,097  393,478 
Accumulated deficit (294,130) (262,685)
Accumulated other comprehensive loss (23,651) (23,266)
Total shareholders’ equity 65,742  85,580 
Total liabilities and shareholders’ equity $269,006  $253,277 
         



AVADEL PHARMACEUTICALS PLC
UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)

  Nine months ended September 30,
  2018 2017
     
Cash flows from operating activities:    
Net (loss) income $(31,445) $76,516 
Adjustments to reconcile net (loss) income to net cash provided by operating activities:    
Depreciation and amortization 5,625  2,664 
Amortization of premiums on marketable securities 2,889  653 
Remeasurement of related party acquisition-related contingent consideration (17,036) (30,107)
Remeasurement of related party financing-related contingent consideration (1,432) (2,988)
Amortization of debt discount and debt issuance costs 3,402   
Change in deferred tax and income tax deferred charge (4,675) 322 
Stock-based compensation expense 7,190  6,019 
Other adjustments 117  (1,076)
Net changes in assets and liabilities    
Accounts receivable 5,059  (6,240)
Inventories (548) (2,612)
Prepaid expenses and other current assets 2,194  1,924 
Research and development tax credit receivable (1,350) (1,576)
Accounts payable & other current liabilities 4,312  804 
Accrued expenses (11,660) 9,324 
Accrued income taxes (228) 5,826 
Earn-out payments for related party contingent consideration in excess of acquisition-date fair value (16,254) (24,729)
Royalty payments for related party payable in excess of original fair value (2,362) (3,446)
Other assets and liabilities (1,988) (800)
Net cash (used in) provided by operating activities (58,190) 30,478 
     
Cash flows from investing activities:    
Purchases of property and equipment (167) (533)
Purchase of intangible asset (20,000) (52,139)
Proceeds from sales of marketable securities 308,015  153,398 
Purchases of marketable securities (341,036) (115,893)
Net cash used in investing activities (53,188) (15,167)
     
Cash flows from financing activities:    
Earn-out payments for related party contingent consideration (645) (961)
Proceeds from debt issuance 143,750   
Payments for debt issuance costs (6,190)  
Share repurchases (27,637) (16,707)
Proceeds from the issuance of ordinary shares and warrants 3,488  376 
Other financing activities, net (31)  
Net cash provided by (used in) financing activities 112,735  (17,292)
     
Effect of foreign currency exchange rate changes on cash and cash equivalents (84) 215 
     
Net change in cash and cash equivalents 1,273  (1,766)
Cash and cash equivalents at January 1, 16,564  39,215 
Cash and cash equivalents at September 30, $17,837  $37,449 
         


AVADEL PHARMACEUTICALS PLC
UNAUDITED SUPPLEMENTAL INFORMATION
(In thousands, except per share data)

  Three Months Ended September 30, Nine Months Ended September 30,
Revenues by Product: 2018 2017 2018 2017
         
Bloxiverz $3,656  $9,920  $16,691  $37,541 
Vazculep 8,759  9,573  33,097  29,906 
Akovaz 5,991  18,561  28,083  65,110 
Noctiva 1,047    2,002   
Other 373  1,093  2,230  5,452 
Total product sales 19,826  39,147  82,103  138,009 
License revenue   528  246  484 
Total revenues $19,826  $39,675  $82,349  $138,493 
                 


         
    GAAP to Non-GAAP adjustments for the three-months ended September 30, 2018    
    Exclude Include    
  GAAP Intangible asset amortization Foreign exchange (gain)/loss Restructuring impacts Equity securities unrealized (gain)/loss impact Amortization of debt discount and debt issuance costs Contingent related party payable fair value remeasurements Contingent related party payable paid/accrued Total adjustments Adjusted GAAP
                     
Revenues:                    
Product sales $19,826  $  $  $  $  $  $  $  $  $19,826 
License revenue                    
Total revenues 19,826                  19,826 
Operating expenses:                    
Cost of products 3,120                  3,120 
Research and development expenses 11,402                  11,402 
Selling, general and administrative expenses 24,829                  24,829 
Intangible asset amortization 1,620  (1,620)             (1,620)  
Gain - changes in fair value of related party contingent consideration (7,115)           7,115  3,182  10,297  3,182 
Restructuring costs 65      (65)         (65)  
Total operating expenses 33,921  (1,620)   (65)     7,115  3,182  8,612  42,533 
Operating (loss) income (14,095) 1,620    65      (7,115) (3,182) (8,612) (22,707)
Investment and other income, net 208    7    (53)       (46) 162 
Interest expense (3,000)         1,383      1,383  (1,617)
Other income - changes in fair value of related party payable 425            (425) (484) (909) (484)
(Loss) income before income taxes (16,462) 1,620  7  65  (53) 1,383  (7,540) (3,666) (8,184) (24,646)
Income tax (benefit) provision (691) 341      4    (186) (145) 14  (677)
Net (loss) income $(15,771) $1,279  $7  $65  $(57) $1,383  $(7,354) $(3,521) $(8,198) $(23,969)
                     
Net income (loss) per share - diluted(1) $(0.43) $0.03  $  $  $  $0.04  $(0.20) $(0.10) $(0.22) $(0.65)
Weighted average number of shares outstanding - diluted 36,904  36,904  36,904  36,904  36,904  36,904  36,904  36,904  36,904  36,904 

(1)  Net income (loss) per share - diluted is calculated by dividing Net income (loss) by the Weighted average number of shares outstanding - diluted. Note, when recalculated using this method, the balances in the Total adjustment and Adjusted GAAP columns may not cross-foot as a result of rounding to full precision.

         
    GAAP to Non-GAAP adjustments for the three-months ended
September 30, 2017
    
    Exclude Include    
  GAAP Intangible asset amortization Foreign exchange (gain)/loss Restructuring impacts Contingent related party payable fair value remeasurements Contingent related party payable paid/accrued Total adjustments Adjusted GAAP
                 
Revenues:                
Product sales $39,147  $  $  $  $  $  $  $39,147 
License revenue 528              528 
Total revenues 39,675              39,675 
Operating expenses:                
Cost of products 3,790              3,790 
Research and development expenses 8,095              8,095 
Selling, general and administrative expenses 11,563              11,563 
Intangible asset amortization 564  (564)         (564)  
Gain - changes in fair value of related party contingent consideration (9,906)       9,906  7,264  17,170  7,264 
Restructuring costs (549)     549      549   
Total operating expenses 13,557  (564)   549  9,906  7,264  17,155  30,712 
Operating income (loss) 26,118  564    (549) (9,906) (7,264) (17,155) 8,963 
Investment and other income, net 977    133        133  1,110 
Interest expense (263)             (263)
Other income - changes in fair value of related party payable 768        (768) (963) (1,731) (963)
Income (loss) before income taxes 27,600  564  133  (549) (10,674) (8,227) (18,753) 8,847 
Income tax provision (benefit) 5,921  201      (507) (515) (821) 5,100 
Net income (loss) $21,679  $363  $133  $(549) $(10,167) $(7,712) $(17,932) $3,747 
                 
Net income (loss) per share - diluted(1) $0.52  $0.01  $  $(0.01) $(0.25) $(0.19) $(0.43) $0.09 
Weighted average number of shares outstanding - diluted 41,339  41,339  41,339  41,339  41,339  41,339  41,339  41,339 
                         

(1) Net income (loss) per share - diluted is calculated by dividing Net income (loss) by the Weighted average number of shares outstanding - diluted. Note, when recalculated using this method, the balances in the Total adjustment and Adjusted GAAP columns may not cross-foot as a result of rounding to full precision.

         
    GAAP to Non-GAAP adjustments for the nine-months ended September 30, 2018    
    Exclude Include    
  GAAP Intangible asset amortization Foreign exchange (gain)/loss Restructuring impacts Equity securities unrealized (gain)/loss impact Amortization of debt discount and debt issuance costs Contingent related party payable fair value remeasurements Contingent related party payable paid/accrued Total adjustments Adjusted GAAP
                     
Revenues:                    
Product sales $82,103  $  $  $  $  $  $  $  $  $82,103 
License revenue 246                  246 
Total revenues 82,349                  82,349 
Operating expenses:                    
Cost of products 13,224                  13,224 
Research and development expenses 33,243                  33,243 
Selling, general and administrative expenses 77,159                  77,159 
Intangible asset amortization 4,996  (4,996)             (4,996)  
Gain - changes in fair value of related party contingent consideration (17,036)           17,036  14,032  31,068  14,032 
Restructuring costs 268      (268)         (268)  
Total operating expenses 111,854  (4,996)   (268)     17,036  14,032  25,804  137,658 
Operating (loss) income (29,505) 4,996    268      (17,036) (14,032) (25,804) (55,309)
Investment and other income, net 845    (153)   133        (20) 825 
Interest expense (7,577)         3,402      3,402  (4,175)
Other income - changes in fair value of related party payable 1,432            (1,432) (2,032) (3,464) (2,032)
(Loss) income before income taxes (34,805) 4,996  (153) 268  133  3,402  (18,468) (16,064) (25,886) (60,691)
Income tax (benefit) provision (3,360) 1,050      (1)   (534) (618) (103) (3,463)
Net (loss) income $(31,445) $3,946  $(153) $268  $134  $3,402  $(17,934) $(15,446) $(25,783) $(57,228)
                     
Net income (loss) per share - diluted(1) $(0.84) $0.11  $  $0.01  $  $0.09  $(0.48) $(0.41) $(0.69) $(1.53)
Weighted average number of shares outstanding - diluted 37,410  37,410  37,410  37,410  37,410  37,410  37,410  37,410  37,410  37,410 
                               


         
    GAAP to Non-GAAP adjustments for the nine-months ended September 30, 2017    
    Exclude Include    
  GAAP Intangible asset amortization Foreign exchange (gain)/loss Restructuring impacts Purchase accounting adjustments - FSC License revenue adjustment Contingent related party payable fair value remeasurements Contingent related party payable paid/accrued Total adjustments Adjusted GAAP
                     
Revenues:                    
Product sales $138,009  $  $  $  $  $  $  $  $  $138,009 
License revenue 484          1,100      1,100  1,584 
Total revenues 138,493          1,100      1,100  139,593 
Operating expenses:                    
Cost of products 12,253        (46)       (46) 12,207 
Research and development expenses 22,093                  22,093 
Selling, general and administrative expenses 35,804                  35,804 
Intangible asset amortization 1,692  (1,692)             (1,692)  
Gain - changes in fair value of related party contingent consideration (30,107)           30,107  25,396  55,503  25,396 
Restructuring costs 3,173      (3,173)         (3,173)  
Total operating expenses 44,908  (1,692)   (3,173) (46)   30,107  25,396  50,592  95,500 
Operating income (loss) 93,585  1,692    3,173  46  1,100  (30,107) (25,396) (49,492) 44,093 
Investment and other income, net 2,562    127            127  2,689 
Interest expense (789)                 (789)
Other income - changes in fair value of related party payable 2,988            (2,988) (3,428) (6,416) (3,428)
Income (loss) before income taxes 98,346  1,692  127  3,173  46  1,100  (33,095) (28,824) (55,781) 42,565 
Income tax provision (benefit) 21,830  603      17    (1,776) (1,822) (2,978) 18,852 
Net income (loss) $76,516  $1,089  $127  $3,173  $29  $1,100  $(31,319) $(27,002) $(52,803) $23,713 
                     
Net income (loss) per share - diluted(1) $1.81  $0.03  $  $0.08  $  $0.03  $(0.74) $(0.64) $(1.25) $0.56 
Weighted average number of shares outstanding - diluted 42,194  42,194  42,194  42,194  42,194  42,194  42,194  42,194  42,194  42,194 
                               

(1)  Net income (loss) per share - diluted is calculated by dividing Net income (loss) by the Weighted average number of shares outstanding - diluted. Note, when recalculated using this method, the balances in the Total adjustment and Adjusted GAAP columns may not cross-foot as a result of rounding to full precision.