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CST: 17/09/2019 20:32:14   

Avadel Pharmaceuticals Reports Fourth Quarter and Full Year 2018 Financial Results

186 Days ago

DUBLIN, Ireland, March 15, 2019 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (Nasdaq: AVDL), a company focused on developing FT218 for sleep disorders, today announced its financial results for the fourth quarter and full year of 2018.

“We have recently announced a restructuring and other activities to focus our efforts and resources toward advancing our lead clinical-stage asset, FT218,” said Greg Divis, Interim Chief Executive Officer of Avadel. “Cost savings generated by the restructuring, along with hospital product cash flow, are expected to extend our cash runway into 2021.  In conjunction with the restructuring, we have engaged a third-party to review the FT218 development program with the goal of identifying opportunities to enhance the FT218 FDA submission.  With a focused commitment to advancing FT218 and building shareholder value, we look forward to keeping you updated on our progress."

Overview of fourth quarter and full year 2018 financial results:

Revenues for the fourth quarter 2018 were $20.9 million, compared to $34.8 million in the fourth quarter 2017. The decline on a year-over-year basis was primarily attributed to lower net selling prices across all of the Company’s hospital products as a result of increased market competition. Noctiva revenues for the three and twelve months ended December 31, 2018 include an adjustment of $1.4 million to account for higher estimated product returns largely due to Avadel Specialty Pharmaceutical, LLC’s intention to exit the Noctiva product as announced on February 7, 2019.

  Three Months Ended December 31,   Twelve Months Ended December 31,
 Revenues by Product: ($ in 000s) 2018   2017   2018   2017
               
Bloxiverz $ 4,159     $ 8,055     $ 20,850     $ 45,596  
Vazculep 9,819     8,281     42,916     38,187  
Akovaz 5,676     15,507     33,759     80,617  
Noctiva (798 )       1,204      
Other 464     2,989     2,694     8,441  
Total product sales 19,320     34,832     101,423     172,841  
License revenue 1,600     (80 )   1,846     404  
Total revenues $ 20,920     $ 34,752     $ 103,269     $ 173,245  

Research and development (R&D) expense was $6.1 million in the fourth quarter of 2018 compared to $11.3 million in the fourth quarter of 2017. For the full year 2018, R&D expense was $39.3 million compared to $33.4 million in 2017. The increase was primarily due to costs associated with the Phase 3 REST-ON clinical trial for FT218. A portion of the higher R&D spending, when compared to 2017, was due to R&D costs of approximately $1.1 million associated with Noctiva. The Company continues to invest a substantial portion of its R&D budget on the FT218 development program.

Selling, general and administrative (SG&A) expense was $23.2 million in the fourth quarter of 2018 compared to $23.1 million for the fourth quarter of 2017. For the full year 2018, SG&A was $100.4 million compared to $58.9 million in 2017. This increase for the full year was primarily due to $47.6 million of sales and marketing costs associated with the May 2018 launch of Noctiva, partially offset by $8.7 million of lower SG&A expense related to the February 2018 divestiture of the Company’s pediatric assets.

During the fourth quarter of 2018, the Company recorded an impairment charge of $66.1 million to write-off the carrying value of the Noctiva intangible asset.  The Company evaluated the long-term sales outlook of Noctiva and concluded that the associated cash flows did not support its carrying value.  The February 6, 2019 Chapter 11 Bankruptcy filing of Avadel Specialty Pharmaceuticals, LLC, the subsidiary which markets, sells and distributes Noctiva, confirmed management’s conclusion that the intangible asset was fully impaired as of December 31, 2018.  

GAAP net loss for the fourth quarter of 2018 was $63.9 million or $1.72 per share compared to a net loss of $8.2 million or $0.21 per share for the same period in 2017. For the full year, 2018 GAAP net loss was $95.3 million or $2.55 per share compared to a net income of $68.3 million or $1.63 per diluted share in 2017.

The decrease in net income is largely attributable to lower revenues from the Company’s hospital products, higher SG&A due to the 2018 launch of Noctiva, increased R&D spending on the Phase 3 REST-ON trial and the 2018 impairment charge related to the Noctiva intangible asset. 

Non-GAAP1 adjusted net loss for the fourth quarter of 2018 was $17.0 million or $0.46 per share compared to a non-GAAP adjusted net loss of $10.0 million or $0.25 per share in the same period last year. For the full year, 2018 non-GAAP adjusted net loss was $74.2 million or $1.99 per share compared to non-GAAP adjusted net income of $13.8 million or $0.33 per diluted share in 2017. Please see the Supplemental Information section within this document for a reconciliation of adjusted net income and adjusted per share amounts to the respective GAAP amounts.

Cash, cash equivalents and marketable securities were $99.9 million as of December 31, 2018, compared to $94.1 million as of December 31, 2017.

(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.

2019 Guidance:

As a result of the Company’s recently announced restructuring, cash is anticipated to be sufficient to fund operations into 2021.  The hospital products business is expected to generate revenues of between $13 and $15 million in the first quarter of 2019. However, due to increased competition from products launched, expected to be launched in 2019, and possible market price actions, revenues for 2019 could be below $30 million. This possibility is incorporated into the cash runway guidance. Additionally, the Company anticipates submitting an NDA in March of 2019 on a fourth Hospital Product, AV001, which, if approved, could contribute revenues to Avadel in 2020.

Conference Call:

A conference call to discuss these results has been scheduled for Friday, March 15, 2019 at 8:30 a.m. EDT. 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 branded specialty pharmaceutical company.  The Company’s primary focus is on the development and potential FDA approval for FT218, which is in a Phase 3 clinical trial for the treatment of narcolepsy patients suffering from excessive daytime sleepiness (EDS) and cataplexy.  In addition, Avadel markets three sterile injectable drugs used in the hospital setting, which were developed under the Company’s “unapproved marketed drug” (UMD) program.  Avadel is headquartered in Dublin, Ireland with operations in St. Louis, Missouri and Lyon, France. For more information, please visit www.avadel.com.

Cautionary Disclosure Regarding Forward-Looking Statements

This press release includes “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. These forward-looking statements relate to our future expectations, beliefs, plans, strategies, objectives, results, conditions, financial performance, prospects, or other events. In some cases, forward-looking statements can be identified by the use of words such as “will,” “may,” “believe,” “expect,” “guidance,” “anticipate,” “estimate,” “project” and similar expressions, and the negatives thereof (if applicable).

Our forward-looking statements are based on estimates and assumptions that are made within the bounds of our knowledge of our business and operations and that we consider reasonable.  However, 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.  Factors that could cause actual results to differ from expectations in our forward-looking statements include:

(a) risks relating to our 2018 net loss and recent restructuring plan, including risks relating to the following:

  •        our ability to fully pursue our business strategy is limited due to a decrease in our available liquid assets;
     
  •    our recent restructuring plan may not be as effective as we anticipate and may have unintended negative impacts;
     
  •  further restructuring actions, if needed, may require third-party consents that may not be granted;
     
  •  the Chapter 11 bankruptcy filing by our subsidiary Avadel Specialty Pharmaceuticals LLC may have unexpected adverse results; and
     
  •  a management-directed third-party evaluation of our FT218 development program could result in changes that increase the cost of the program and further delay its completion;
     

(b) risks relating to the following:

  •              our three products Bloxiverz®, Vazculep® and Akovaz®, which are not patent protected, and have a small number of customers for such products, produce a majority of our revenues, and such products could face further competition resulting in a loss of market share and/or forcing us to further reduce our prices for those products;
     
  •              we could fail to develop our current “unapproved marketed drug” (UMD) product candidate, AV001, or future potential UMD product candidates, or competitors could develop such products and apply for FDA approval of such products before us;
     
  •              we could experience failure or delay in completing the Phase III clinical trial for our FT-218 product, and if the FDA ultimately approves such product, the approval may not include any period of market exclusivity;
     
  •              Servicing our $143.75 million Exchangeable Senior Notes due 2023 may require a significant amount of cash, and we may not have sufficient cash or the ability to raise the funds necessary to settle exchanges of the 2023 Notes in cash, repay the Notes at maturity, or repurchase the 2023 Notes as required following a “fundamental change” event described in the indenture governing the 2023 Notes;
     
  •              our products may not reach the commercial market or gain market acceptance;
     
  •  we must invest substantial sums in research and development in order to remain competitive;
     
  •      we depend on one or a limited number of providers to develop certain of our products and drug delivery technologies, to manufacture certain of our products and to provide certain raw materials used in our products;
     
  •      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;
     
  •      we face challenges in protecting intellectual property underlying our products and drug delivery technologies; and
     
  •    we depend on key personnel to execute our business plan.

(c) the other risks and uncertainties described in the “Risk Factors” section of Part I, Item 1A of our Annual Report on Form 10-K for the year ended December 31, 2017 which we filed with the Securities and Exchange Commission on March 16, 2018.

Forward-looking statements speak only as of the date they are made and are not guarantees of future performance.  Accordingly, you should not place undue reliance on forward-looking statements.  We do not undertake any obligation to publicly update or revise the forward-looking statements contained in this Annual Report.

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.  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 payment obligations 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 
   
  Alex Gray
  Burns McClellan
  Phone: (212) 213-0006
  Email: agray@burnsmc.com 

AVADEL PHARMACEUTICALS PLC

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF INCOME (LOSS)

(In thousands, except per share data)

    Three Months Ended December 31,   Twelve months ended December 31,
    2018   2017   2018   2017
                 
Revenues:                
Product sales   $ 19,320     $ 34,832     $ 101,423     $ 172,841  
License revenue   1,600     (80 )   1,846     404  
Total revenues   20,920     34,752     103,269     173,245  
Operating expenses:                
Cost of products   4,292     4,048     17,516     16,301  
Research and development expenses   6,086     11,325     39,329     33,418  
Selling, general and administrative expenses   23,200     23,056     100,359     58,860  
Intangible asset amortization   1,623     1,967     6,619     3,659  
(Gain) loss - changes in fair value of related party contingent consideration   (5,695 )   (933 )   (22,731 )   (31,040 )
Impairment of intangible asset   66,087         66,087      
Restructuring costs   748     (631 )   1,016     2,542  
Total operating expenses   96,341     38,832     208,195     83,740  
Operating (loss) income   (75,421 )   (4,080 )   (104,926 )   89,505  
Investment and other income, net   (393 )   (426 )   452     2,136  
Interest expense   (3,045 )   (263 )   (10,622 )   (1,052 )
Other income (expense) - changes in fair value of related party payable   467     (917 )   1,899     2,071  
(Loss) income before income taxes   (78,392 )   (5,686 )   (113,197 )   92,660  
Income tax (benefit) provision   (14,533 )   2,559     (17,893 )   24,389  
Net (loss) income   $ (63,859 )   $ (8,245 )   $ (95,304 )   $ 68,271  
                 
Net (loss) income per share - basic   $ (1.72 )   $ (0.21 )   $ (2.55 )   $ 1.69  
Net (loss) income per share - diluted   (1.72 )   (0.21 )   (2.55 )   1.63  
                 
Weighted average number of shares outstanding - basic   37,073     39,350     37,325     40,465  
Weighted average number of shares outstanding - diluted   37,073     39,350     37,325     41,765  



AVADEL PHARMACEUTICALS PLC

UNAUDITED CONDENSED CONSOLIDATED BALANCE SHEETS

(In thousands, except per share data)

    December 31, 2018   December 31, 2017
         
ASSETS        
Current assets:        
Cash and cash equivalents   $ 9,325     $ 16,564  
Marketable securities   90,590     77,511  
Accounts receivable   11,330     14,785  
Inventories, net   4,770     6,157  
Prepaid expenses and other current assets   8,836     8,958  
Total current assets   124,851     123,975  
Property and equipment, net   1,911     3,001  
Goodwill   18,491     18,491  
Intangible assets, net   1,629     92,289  
Research and development tax credit receivable   7,272     5,272  
Other non-current assets   36,146     10,249  
Total assets   $ 190,300     $ 253,277  
         
LIABILITIES AND SHAREHOLDERS’ EQUITY        
Current liabilities:        
Current portion of long-term debt   $ 106     $ 111  
Current portion of long-term related party payable   9,439     25,007  
Accounts payable   3,503     7,477  
Deferred revenue   114     2,007  
Accrued expenses   21,695     50,926  
Income taxes   73     414  
Other current liabilities   3,453     597  
Total current liabilities   38,383     86,539  
Long-term debt, less current portion   115,734     156  
Long-term related party payable, less current portion   19,401     73,918  
Other non-current liabilities   14,002     7,084  
Total liabilities   187,520     167,697  
         
Shareholders’ equity:        
Preferred shares, nominal value of $0.01 per share; 50,000 shares authorized; none issued or outstanding at December 31, 2018 and December 31, 2017, respectively        
Ordinary shares, nominal value of $0.01 per share; 500,000 shares authorized; 42,720 issued and 37,313 outstanding at December 31, 2018, and 41,463 issued and 39,346 outstanding at December 31, 2017   427     414  
Treasury shares, at cost, 5,407 and 2,117 shares held at December 31, 2018 and December 31, 2017, respectively   (49,998 )   (22,361 )
Additional paid-in capital   433,756     393,478  
Accumulated deficit   (357,989 )   (262,685 )
Accumulated other comprehensive loss   (23,416 )   (23,266 )
Total shareholders’ equity   2,780     85,580  
Total liabilities and shareholders’ equity   $ 190,300     $ 253,277  


AVADEL PHARMACEUTICALS PLC

UNAUDITED CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS

(In thousands)

    Twelve months ended December 31,
    2018   2017
         
Cash flows from operating activities:        
Net (loss) income   $ (95,304 )   $ 68,271  
Adjustments to reconcile net (loss) income to net cash provided by operating activities:        
Depreciation and amortization   7,430     4,883  
Impairment of intangible asset   66,087      
Amortization of premiums on marketable securities   2,823     732  
Remeasurement of related party acquisition-related contingent consideration   (22,731 )   (31,040 )
Remeasurement of related party financing-related contingent consideration   (1,899 )   (2,071 )
Amortization of debt discount and debt issuance costs   4,830      
Change in deferred tax and income tax deferred charge   (19,153 )   3,556  
Stock-based compensation expense   7,852     8,072  
Other adjustments   1,365     (968 )
Net changes in assets and liabilities        
Accounts receivable   3,452     3,054  
Inventories, net   711     (2,899 )
Prepaid expenses and other current assets   3,577     (3,741 )
Research and development tax credit receivable   (2,545 )   (3,141 )
Accounts payable & other current liabilities   (2,032 )   595  
Deferred revenue   (1,892 )   (216 )
Accrued expenses   (10,640 )   13,187  
Accrued income taxes   (341 )   (786 )
Earn-out payments for related party contingent consideration in excess of acquisition-date fair value   (19,468 )   (31,636 )
Royalty payments for related party payable in excess of original fair value   (2,838 )   (4,429 )
Other assets and liabilities   (2,000 )   (4,761 )
Net cash (used in) provided by operating activities   (82,716 )   16,662  
         
Cash flows from investing activities:        
Purchases of property and equipment   (178 )   (591 )
Purchase of intangible assets   (20,000 )   (53,111 )
Proceeds from sales of marketable securities   359,507     189,009  
Purchases of marketable securities   (376,310 )   (151,005 )
Net cash used in investing activities   (36,981 )   (15,698 )
         
Cash flows from financing activities:        
Proceeds from debt issuance   143,750      
Payments for debt issuance costs   (6,190 )    
Earn-out payments for related party contingent consideration   (645 )   (1,246 )
Exercise of warrants   2,911      
Proceeds from issuance of ordinary shares and warrants   577     404  
Share repurchases   (27,637 )   (22,361 )
Other financing activities, net   (107 )   (115 )
Net cash provided by (used in) financing activities   112,659     (23,318 )
Effect of foreign currency exchange rate changes on cash and cash equivalents   (201 )   (297 )
Net change in cash and cash equivalents   (7,239 )   (22,651 )
Cash and cash equivalents at January 1   16,564     39,215  
Cash and cash equivalents at December 31   $ 9,325     $ 16,564  


AVADEL PHARMACEUTICALS PLC

UNAUDITED SUPPLEMENTAL INFORMATION

(In thousands, except per share data)

    Three Months Ended December 31,   Twelve Months Ended December 31,
 Revenue by Product:   2018   2017   2018   2017
                 
Bloxiverz   $ 4,159     $ 8,055     $ 20,850     $ 45,596  
Vazculep   9,819     8,281     42,916     38,187  
Akovaz   5,676     15,507     33,759     80,617  
Noctiva   (798 )       1,204      
Other   464     2,989     2,694     8,441  
Total product sales   19,320     34,832     101,423     172,841  
License revenue   1,600     (80 )   1,846     404  
Total revenues   $ 20,920     $ 34,752     $ 103,269     $ 173,245  


        GAAP to Non-GAAP adjustments for the three-months ended December 31, 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
  Impairment
of intangible
asset
  Contingent
related party
payable
fair
value remeasurements
  Contingent
related
party
payable paid/accrued
  Total adjustments   Adjusted
GAAP
                                             
Revenues:                                            
Product sales   $ 19,320     $     $     $     $     $     $     $     $     $     $ 19,320  
License revenue   1,600                                         1,600  
Total revenues   20,920                                         20,920  
Operating expenses:                                            
Cost of products   4,292                                         4,292  
Research and development expenses   6,086                                         6,086  
Selling, general and administrative expenses   23,200                                         23,200  
Intangible asset amortization   1,623     (1,623 )                               (1,623 )    
(Gain) loss - changes in fair value of related party contingent consideration   (5,695 )                           5,695     3,193     8,888     3,193  
Impairment of intangible asset   66,087                         (66,087 )           (66,087 )    
Restructuring costs   748             (748 )                       (748 )    
Total operating expenses   96,341     (1,623 )       (748 )           (66,087 )   5,695     3,193     (59,570 )   36,771  
Operating (loss) income   (75,421 )   1,623         748             66,087     (5,695 )   (3,193 )   59,570     (15,851 )
Investment and other income, net   (393 )       (60 )       822                     762     369  
Interest expense   (3,045 )                   1,428                 1,428     (1,617 )
Other income (expense) - changes in fair value of related party payable   467                             (467 )   (518 )   (985 )   (518 )
(Loss) income before income taxes   (78,392 )   1,623     (60 )   748     822     1,428     66,087     (6,162 )   (3,711 )   60,775     (17,617 )
Income tax (benefit) provision   (14,533 )   340                     13,879     (175 )   (151 )   13,893     (640 )
Net (loss) income   $ (63,859 )   $ 1,283     $ (60 )   $ 748     $ 822     $ 1,428     $ 52,208     $ (5,987 )   $ (3,560 )   $ 46,882     $ (16,977 )
                                             
Net income (loss) per share - diluted(1)   $ (1.72 )   $ 0.03     $     $ 0.02     $ 0.02     $ 0.04     $ 1.41     $ (0.16 )   $ (0.10 )   $ 1.26     $ (0.46 )
Weighted average number of shares outstanding - diluted   37,073     37,073     37,073     37,073     37,073     37,073     37,073     37,073     37,073     37,073     37,073  

(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 December 31, 2017        
        Exclude   Include        
    GAAP   Intangible
asset amortization
  Foreign
exchange (gain)/loss
  Restructuring impacts   License
revenue adjustment
  US
tax
reform impact
  Contingent
related
party
payable
fair value remeasurements
  Contingent
related
party
payable paid/accrued
  Total adjustments   Adjusted
GAAP
                                         
Revenues:                                        
Product sales   $ 34,832     $     $     $     $     $     $     $     $     $ 34,832  
License revenue   (80 )               342                 342     262  
Total revenues   34,752                 342                 342     35,094  
Operating expenses:                                        
Cost of products   4,048                                     4,048  
Research and development expenses   11,325                                     11,325  
Selling, general and administrative expenses   23,056                                     23,056  
Intangible asset amortization   1,967     (1,967 )                           (1,967 )    
(Gain) loss - changes in fair value of related party contingent consideration   (933 )                       933     6,067     7,000     6,067  
Restructuring costs   (631 )           631                     631      
Total operating expenses   38,832     (1,967 )       631             933     6,067     5,664     44,496  
Operating (loss) income   (4,080 )   1,967         (631 )   342         (933 )   (6,067 )   (5,322 )   (9,402 )
Investment and other income, net   (426 )       587                         587     161  
Interest expense   (263 )                                   (263 )
Other income (expense) - changes in fair value of related party payable   (917 )                       917     (831 )   86     (831 )
(Loss) income before income taxes   (5,686 )   1,967     587     (631 )   342         (16 )   (6,898 )   (4,649 )   (10,335 )
Income tax (benefit) provision   2,559     706                 (3,513 )   307     (438 )   (2,938 )   (379 )
Net (loss) income   $ (8,245 )   $ 1,261     $ 587     $ (631 )   $ 342     $ 3,513     $ (323 )   $ (6,460 )   $ (1,711 )   $ (9,956 )
                                         
Net income (loss) per share - diluted(1)   $ (0.21 )   $ 0.03     $ 0.01     $ (0.02 )   $ 0.01     $ 0.09     $ (0.01 )   $ (0.16 )   $ (0.04 )   $ (0.25 )
Weighted average number of shares outstanding - diluted   39,350     39,350     39,350     39,350     39,350     39,350     39,350     39,350     39,350     39,350  

(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 twelve-months ended December 31, 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
  Impairment
of intangible asset
  Contingent
related
party
payable
fair value remeasurements
  Contingent
related
party
payable paid/accrued
  Total adjustments   Adjusted
GAAP
                                             
Revenues:                                            
Product sales   $ 101,423     $     $     $     $     $     $     $     $     $     $ 101,423  
License revenue   1,846                                         1,846  
Total revenues   103,269                                         103,269  
Operating expenses:                                            
Cost of products   17,516                                         17,516  
Research and development expenses   39,329                                         39,329  
Selling, general and administrative expenses   100,359                                         100,359  
Intangible asset amortization   6,619     (6,619 )                               (6,619 )    
(Gain) loss - changes in fair value of related party contingent consideration   (22,731 )                           22,731     17,225     39,956     17,225  
Impairment of intangible asset   66,087                         (66,087 )           (66,087 )    
Restructuring costs   1,016             (1,016 )                       (1,016 )    
Total operating expenses   208,195     (6,619 )       (1,016 )           (66,087 )   22,731     17,225     (33,766 )   174,429  
Operating (loss) income   (104,926 )   6,619         1,016             66,087     (22,731 )   (17,225 )   33,766     (71,160 )
Investment and other income, net   452         (213 )       955                     742     1,194  
Interest expense   (10,622 )                   4,830                 4,830     (5,792 )
Other income (expense) - changes in fair value of related party payable   1,899                             (1,899 )   (2,550 )   (4,449 )   (2,550 )
(Loss) income before income taxes   (113,197 )   6,619     (213 )   1,016     955     4,830     66,087     (24,630 )   (19,775 )   34,889     (78,308 )
Income tax (benefit) provision   (17,893 )   1,390             (1 )       13,879     (709 )   (769 )   13,790     (4,103 )
Net (loss) income   $ (95,304 )   $ 5,229     $ (213 )   $ 1,016     $ 956     $ 4,830     $ 52,208     $ (23,921 )   $ (19,006 )   $ 21,099     $ (74,205 )
                                             
Net income (loss) per share - diluted(1)   $ (2.55 )   $ 0.14     $ (0.01 )   $ 0.03     $ 0.03     $ 0.13     $ 1.40     $ (0.64 )   $ (0.51 )   $ 0.57     $ (1.99 )
Weighted average number of shares outstanding - diluted   37,325     37,325     37,325     37,325     37,325     37,325     37,325     37,325     37,325     37,325     37,325  

(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 twelve-months ended December 31, 2017        
        Exclude   Include        
    GAAP   Intangible
asset amortization
  Foreign exchange (gain)/loss   Restructuring impacts   Purchase
accounting adjustments - FSC
  License revenue adjustment   US
tax reform adjustment
  Contingent
related
party
payable
fair value remeasurements
  Contingent
related
party
payable paid/accrued
  Total adjustments   Adjusted GAAP
                                             
Revenues:                                            
Product sales   $ 172,841     $     $     $     $     $     $     $     $     $     $ 172,841  
License revenue   404                     1,442                 1,442     1,846  
Total revenues   173,245                     1,442                 1,442     174,687  
Operating expenses:                                            
Cost of products   16,301                 (46 )                   (46 )   16,255  
Research and development expenses   33,418                                         33,418  
Selling, general and administrative expenses   58,860                                         58,860  
Intangible asset amortization   3,659     (3,659 )                               (3,659 )    
(Gain) loss - changes in fair value of related party contingent consideration   (31,040 )                           31,040     31,463     62,503     31,463  
Restructuring costs   2,542             (2,542 )                       (2,542 )    
Total operating expenses   83,740     (3,659 )       (2,542 )   (46 )           31,040     31,463     56,256     139,996  
Operating (loss) income   89,505     3,659         2,542     46     1,442         (31,040 )   (31,463 )   (54,814 )   34,691  
Investment and other income, net   2,136         714                             714     2,850  
Interest expense   (1,052 )                                       (1,052 )
Other income (expense) - changes in fair value of related party payable   2,071                             (2,071 )   (4,259 )   (6,330 )   (4,259 )
(Loss) income before income taxes   92,660     3,659     714     2,542     46     1,442         (33,111 )   (35,722 )   (60,430 )   32,230  
Income tax (benefit) provision   24,389     1,309             17         (3,513 )   (1,469 )   (2,260 )   (5,916 )   18,473  
Net (loss) income   $ 68,271     $ 2,350     $ 714     $ 2,542     $ 29     $ 1,442     $ 3,513     $ (31,642 )   $ (33,462 )   $ (54,514 )   $ 13,757  
                                             
Net income (loss) per share - diluted(1)   $ 1.63     $ 0.06     $ 0.02     $ 0.06     $     $ 0.03     $ 0.08     $ (0.76 )   $ (0.80 )   $ (1.31 )   $ 0.33  
Weighted average number of shares outstanding - diluted   41,765     41,765     41,765     41,765     41,765     41,765     41,765     41,765     41,765     41,765     41,765  

(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.

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