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Avadel Pharmaceuticals Reports Second Quarter 2018 Financial Results

DUBLIN, Ireland, Aug. 07, 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 second quarter of 2018.

Mike Anderson, Avadel’s Chief Executive Officer, said, “Our second quarter was a period of continued investment and focus on building the foundation that is expected to propel us forward into the future. We came in above consensus with $29 million in revenues, largely from our generic hospital products, and have transformed our investment focus to growth-oriented products that have the potential to deliver long-term shareholder value. We are adequately capitalized to continue this transformation, and over the next 12 - 18 months we expect to accelerate our two near-term growth catalysts, NOCTIVA™ and FT 218.”

Mr. Anderson continued, “We are just a few months into the launch of NOCTIVA, and although net revenue to date is just under one million dollars, we are encouraged with a number of early indicators of positive traction, including prescription demand, active prescribers, and product awareness levels. More than 2,600 prescriptions have been written to date. We have had positive physician reception with more than 1,000 unique prescribers and our unaided brand-awareness level has reached over 60% in just a few short months. Education and increasing the relevance of nocturia as a condition to be treated in and of itself, and improving coverage and patient access, particularly in Part D, are keys to translating this demand into improved revenue numbers and accelerating NOCTIVA’s growth over the next 12-18 months."

“Additionally, we continue to improve recruitment efforts for our REST-ON Phase III trial of our investigational FT 218 drug in patients with narcolepsy. As we enter the second half of this year, we are approximately 50% enrolled. With the FDA’s recent agreement to allow the inclusion of a select group of former sodium oxybate users, we have initiated a database review program across our clinical sites.  We have also implemented a new patient referral program and, over the next few months, we will be adding seven new clinical sites in the U.S., and three in Australia where sodium oxybate is not currently available to patients. We have only been fully operational in our initial U.S. sites for about a year and are confident that these additional measures should continue to improve the enrollment rate for the second half of our study," concluded Mr. Anderson.

Overview of second quarter 2018 financial results:

Revenues:    
  Three Months Ended June 30,
($ in 000s) By Product 2018 2017
     
Bloxiverz $5,544  $ 13,719 
Vazculep  11,377  10,154 
Akovaz 11,875  20,912 
Noctiva 289   
Other 31  2,320 
Product sales 29,116  47,105 
License revenue                                                                                      114  (794)
Total revenues $    29,230  $46,311 
 

Revenues for the second quarter 2018 were $29.2 million, compared to $46.3 million in the second quarter 2017. The decline on a year-over-year basis was attributed to lower net selling prices and units shipped for Bloxiverz® and Akovaz® due to more competition, slightly offset by higher Vaculep® revenues from increased units shipped during the second quarter 2018. Net sales for NOCTIVA were $289,000 in the second quarter 2018, down on a quarter-over-quarter basis from $666,000 due largely to the initial wholesaler stocking that occurred at the end of the first quarter 2018 in anticipation of the May 2018 branded launch.

Operating expenses:    
  Three Months Ended June 30,
($ in 000s) Operating expenses 2018 2017
     
Cost of products $3,512  $4,561 
Research and development expenses (R&D) 11,890  6,792 
Selling, general and administrative expenses (SG&A)                            27,843  12,429 
       

R&D expense was up 75% in the second quarter 2018 compared to the prior year period, primarily due to increased spend on the Phase III REST-ON trial. The $15.5 million increase in SG&A in the second quarter 2018 compared to the second quarter 2017 was due to sales and marketing expenses associated with the launch of NOCTIVA.

GAAP earnings:    
  Three Months Ended June 30,
($ in 000s except for per share) 2018 2017
     
Net (loss) income $(3,438) $28,927
Net (loss) income per share - diluted                                                      (0.09) 0.68
      

Included in GAAP net loss for the second quarter 2018 were gains of $12.9 million related to changes in the fair value of related party contingent consideration, compared to gains of $13.2 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.

Adjusted earnings (1):    
  Three Months Ended June 30,
($ in 000s except for per share) 2018 2017
     
Net (loss) income $(20,261) $8,165 
Net (loss) income per share - diluted                                                    (0.55) 0.19 
       
(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.
 

The decrease in adjusted net income is largely attributable to lower revenues from the Company’s hospital products and higher SG&A due to the 2018 launch of Noctiva.  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.

2018 Guidance:

The Company maintained its full year 2018 spend guidance for R&D of between $40 to $50 million, and SG&A of between $80 to $90 million. Cash interest expense as a result of the Company's convertible notes offering 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. During the second quarter competing products were approved for Vazculep, Bloxiverz and NOCTIVA; as such, the Company is lowering its full year revenue guidance to a range of $90 to $105 million from $105 to $125 million. Included in this range is an estimated $5 to $10 million in revenue from NOCTIVA, down from previous guidance of $10 to $20 million, in part due to a lower than expected net-realized selling price from a less favorable mix of commercially insured to Medicare Part D prescriptions in the initial launch period. The Company expects an increase in net-selling price as it continues to improve script volume and market access throughout the course of the next 12 to 18 months.

Conference Call:

A conference call to discuss these results has been scheduled for Tuesday, August 7, 2018 at 10:00 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 7367859. A live audio webcast can be accessed by visiting the Investors 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” and similar expressions, and 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 reasonable assumptions within the bounds of our knowledge of our business and operations, our business is subject to significant risks and as a result there can be no assurance that actual results of our research, development and commercialization activities and our results of 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 that may be set forth in particular 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 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 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 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.

Non-GAAP Disclosures and Adjustments

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 generally accepted accounting principles (GAAP) in the U.S. In addition to reporting its financial results in accordance with GAAP, Avadel reports certain non-GAAP results that exclude, if any, fair value remeasurements of its contingent consideration, amortization of debt discount and debt issuance costs attributable to our  exchangeable notes, impairment of intangible assets, if any, amortization of intangible assets, restructuring costs, if any, foreign exchange gains and losses on assets and liabilities denominated in foreign currencies, unrealized gains/losses on marketable equity securities,  but includes 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. The Company's management uses these non-GAAP measures internally for forecasting, budgeting and measuring its 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 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 June 30, Six Months Ended June 30,
  2018 2017   2018 2017
         
Revenues:        
Product sales $29,116  $47,105  $62,277  $98,862 
License revenue 114  (794) 246  (44)
Total revenues 29,230  46,311  62,523  98,818 
Operating expenses:        
Cost of products 3,512  4,561  10,104  8,463 
Research and development expenses 11,890  6,792  21,841  13,998 
Selling, general and administrative expenses 27,843  12,429  52,330  24,241 
Intangible asset amortization 1,609  564  3,376  1,128 
Gain - changes in fair value of related party contingent consideration (12,889) (13,230) (9,921) (20,201)
Restructuring costs 50  1,069  203  3,722 
Total operating expenses 32,015  12,185  77,933  31,351 
Operating (loss) income (2,785) 34,126  (15,410) 67,467 
Investment and other income (expense), net 583  764  637  1,585 
Interest expense, net (2,980) (263) (4,577) (526)
Other income - changes in fair value of related party payable 1,402  1,670  1,007  2,220 
(Loss) income before income taxes (3,780) 36,297  (18,343) 70,746 
Income tax (benefit) provision (342) 7,370  (2,669) 15,909 
Net (loss) income $(3,438) $28,927  $(15,674) $54,837 
         
Net (loss) income per share - basic $(0.09) $0.70  $(0.42) $1.33 
Net (loss) income per share - diluted (0.09) 0.68  (0.42) 1.29 
         
Weighted average number of shares outstanding - basic 36,772  41,091  37,666  41,233 
Weighted average number of shares outstanding - diluted 36,772  42,487  37,666  42,625 

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

  June 30, 2018   December 31, 2017
     
ASSETS    
Current assets:    
Cash and cash equivalents $12,477  $16,564 
Marketable securities                      134,629  77,511 
Accounts receivable 14,940  14,785 
Inventories 5,724  6,157 
Prepaid expenses and other current assets 7,206  8,958 
Total current assets 174,976  123,975 
Property and equipment, net 2,439  3,001 
Goodwill 18,491  18,491 
Intangible assets, net 70,962  92,289 
Research and development tax credit receivable 6,124  5,272 
Other non-current assets 22,244  10,249 
Total assets $295,236  $253,277 
     
LIABILITIES AND SHAREHOLDERS’ EQUITY    
Current liabilities:    
Current portion of long-term debt $108  $111 
Current portion of long-term related party payable 14,067  25,007 
Accounts payable 11,169  7,477 
Deferred revenue 1,724  2,007 
Accrued expenses 21,493  50,926 
  Other current liabilities 3,052  1,011 
Total current liabilities 51,613  86,539 
Long-term debt, less current portion 113,038  156 
Long-term related party payable, less current portion 38,050  73,918 
Other non-current liabilities 13,989  7,084 
Total liabilities 216,690  167,697 
     
Shareholders’ equity:      
Preferred shares, $0.01 nominal value; 50,000 shares authorized at June 30, 2018 and December 31, 2017, respectively; none issued or outstanding at June 30, 2018 and December 31, 2017, respectively    
Ordinary shares, nominal value of $0.01; 500,000 shares authorized; 42,148 issued and 36,740 outstanding at June 30, 2018 and 41,463 issued and 39,346 outstanding at December 31, 2017 421  414 
Treasury shares, at cost, 5,408 and 2,117 shares held at June 30, 2018 and December 31, 2017, respectively (49,998) (22,361)
Additional paid-in capital 430,141  393,478 
Accumulated deficit (278,359) (262,685)
Accumulated other comprehensive loss (23,659) (23,266)
Total shareholders’ equity 78,546  85,580 
Total liabilities and shareholders’ equity $295,236  $253,277 
 
 
 

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

 Six Months Ended June 30,
 2018 2017
    
Cash flows from operating activities:   
Net (loss) income$(15,674) $54,837 
Adjustments to reconcile net (loss) income to net cash provided by operating activities:   
Depreciation and amortization3,810  1,611 
Amortization of premiums on marketable securities1,693  34 
Foreign exchange loss(160) 1,304 
Remeasurement of related party acquisition-related contingent consideration(9,921) (20,201)
Remeasurement of related party financing-related contingent consideration(1,007) (2,220)
Amortization of debt discount and debt issuance costs2,019   
Change in deferred tax and income tax deferred charge(3,247) 322 
Stock-based compensation expense4,358  4,055 
Other adjustments251  (115)
Net changes in assets and liabilities   
Accounts receivable(157) (1,446)
Inventories(242) (2,489)
Prepaid expenses and other current assets1,587  (264)
Research and development tax credit receivable(1,003) (1,175)
Accounts payable & other current liabilities5,206  4,931 
Accrued expenses(9,831) 12,747 
Earn-out payments for related party contingent consideration in excess of acquisition-date fair value(11,113) (16,515)
Royalty payments for related party payable in excess of original fair value(1,618) (2,287)
Other assets and liabilities(2,893) 407 
Net cash (used in) provided by operating activities(37,942) 33,536 
    
Cash flows from investing activities:   
Purchases of property and equipment(99) (321)
Purchase of intangible asset(20,000)  
Proceeds from sales of marketable securities253,525  51,820 
Purchases of marketable securities(312,638) (67,743)
Net cash used in investing activities(79,212) (16,244)
    
Cash flows from financing activities:   
Earn-out payments for related party contingent consideration(645) (665)
Proceeds from debt issuance143,750   
Payments for debt issuance costs(5,760)  
Share repurchases(27,637) (13,081)
Cash proceeds from the issuance of ordinary shares and warrants3,446  376 
Other financing activities, net6  12 
Net cash provided by (used in) financing activities113,160  (13,358)
    
Effect of foreign currency exchange rate changes on cash and cash equivalents(93) 358 
    
Net change in cash and cash equivalents(4,087) 4,292 
Cash and cash equivalents at January 1,16,564  39,215 
Cash and cash equivalents at June 30,$12,477  $43,507 

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

  Three Months Ended June 30,   Six Months Ended June 30,
Revenues by Product:   2018 2017 2018 2017
         
Bloxiverz $5,544  $13,719  $13,035  $27,621 
Vazculep 11,377  10,154  24,338  20,334 
Akovaz 11,875  20,912  22,092  46,549 
Noctiva 289    955   
Other 31  2,320  1,857  4,358 
Total product sales 29,116  47,105  62,277  98,862 
License revenue                                                                            114  (794) 246  (44)
Total revenues $29,230  $46,311  $62,523  $98,818 
 
 


   GAAP to Non-GAAP adjustments for the three-months ended June 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$29,116  $  $  $  $  $  $  $  $  $29,116 
License revenue114                  114 
Total revenues29,230                  29,230 
Operating expenses:                   
Cost of products3,512                  3,512 
Research and development expenses11,890                  11,890 
Selling, general and administrative expenses27,843                  27,843 
Intangible asset amortization1,609  (1,609)             (1,609)  
Loss (gain) - changes in fair value of related party contingent
consideration
(12,889)           12,889  5,060  17,949  5,060 
Restructuring costs50      (50)         (50)  
Total operating expenses32,015  (1,609)   (50)     12,889  5,060  16,290  48,305 
Operating (loss) income(2,785) 1,609    50      (12,889) (5,060) (16,290) (19,075)
Investment and other income
(expense), net
583    7    (112)       (105) 478 
Interest expense, net(2,980)         1,363      1,363  (1,617)
Other expense (income) -
changes in fair value of related
party payable
1,402            (1,402) (751) (2,153) (751)
(Loss) income before income
taxes
(3,780) 1,609  7  50  (112) 1,363  (14,291) (5,811) (17,185) (20,965)
Income tax (benefit) provision(342) 338      (2)   (471) (227) (362) (704)
Net (loss) income$(3,438) $1,271  $7  $50  $(110) $1,363  $(13,820) $(5,584) $(16,823) $(20,261)
                    
Net income (loss) per share - diluted(1)$(0.09) $0.03  $  $  $  $0.04  $(0.38) $(0.15) $(0.46) $(0.55)
Weighted average number of
shares outstanding - diluted
36,772  36,772  36,772  36,772  36,772  36,772  36,772  36,772  36,772  36,772 

(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 June 30, 2017    
   Exclude Include    
 GAAP Intangible asset
amortization
 Foreign exchange
(gain)/loss
 Restructuring
impacts
 License revenue
adjustment
 Contingent related party
payable fair value
remeasurements
 Contingent related
party payable
paid/accrued
 Total
adjustments
 Adjusted
GAAP
                  
Revenues:                 
Product sales$47,105  $  $  $  $  $  $  $  $47,105 
License revenue(794)       1,100      1,100  306 
Total revenues46,311        1,100      1,100  47,411 
Operating expenses:                 
Cost of products4,561                4,561 
Research and development expenses6,792                6,792 
Selling, general and administrative expenses12,429                12,429 
Intangible asset amortization564  (564)           (564)  
Loss (gain) - changes in fair value of related party contingent consideration(13,230)         13,230  8,516  21,746  8,516 
Restructuring costs1,069      (1,069)       (1,069)  
Total operating expenses12,185  (564)   (1,069)   13,230  8,516  20,113  32,298 
Operating (loss) income34,126  564    1,069  1,100  (13,230) (8,516) (19,013) 15,113 
Investment and other income (expense), net764    (237)         (237) 527 
Interest expense, net(263)               (263)
Other expense (income) - changes in fair value of related party payable1,670          (1,670) (1,166) (2,836) (1,166)
(Loss) income before income taxes36,297  564  (237) 1,069  1,100  (14,900) (9,682) (22,086) 14,211 
Income tax (benefit) provision7,370  201        (909) (616) (1,324) 6,046 
Net (loss) income$28,927  $363  $(237) $1,069  $1,100  $(13,991) $(9,066) $(20,762) $8,165 
                  
Net income (loss) per share - diluted(1)$0.68  $0.01  $(0.01) $0.03  $0.03  $(0.33) $(0.21) $(0.49) $0.19 
Weighted average number of shares outstanding - diluted42,487  42,487  42,487  42,487  42,487  42,487  42,487  42,487  42,487 

(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 six-months ended June 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$62,277  $  $  $  $  $  $  $  $  $62,277 
License revenue246                  246 
Total revenues62,523                  62,523 
Operating expenses:                   
Cost of products10,104                  10,104 
Research and development expenses21,841                  21,841 
Selling, general and administrative expenses52,330                  52,330 
Intangible asset amortization3,376  (3,376)             (3,376)  
Loss (gain) - changes in fair value of related party contingent consideration(9,921)           9,921  10,850  20,771  10,850 
Restructuring costs203      (203)         (203)  
Total operating expenses77,933  (3,376)   (203)     9,921  10,850  17,192  95,125 
Operating (loss) income(15,410) 3,376    203      (9,921) (10,850) (17,192) (32,602)
Investment and other income (expense), net637    (160)   186        26  663 
Interest expense, net(4,577)         2,019      2,019  (2,558)
Other expense (income) - changes in fair value of related party payable1,007            (1,007) (1,548) (2,555) (1,548)
(Loss) income before income taxes(18,343) 3,376  (160) 203  186  2,019  (10,928) (12,398) (17,702) (36,045)
Income tax (benefit) provision(2,669) 709      (5)   (348) (473) (117) (2,786)
Net (loss) income$(15,674) $2,667  $(160) $203  $191  $2,019  $(10,580) $(11,925) $(17,585) $(33,259)
                    
Net income (loss) per share - diluted(1)$(0.42) $0.07  $  $0.01  $0.01  $0.05  $(0.28) $(0.32) $(0.47) $(0.88)
Weighted average number of shares outstanding - diluted37,666  37,666  37,666  37,666  37,666  37,666  37,666  37,666  37,666  37,666 
                              
                              


   GAAP to Non-GAAP adjustments for the six-months ended June 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$98,862  $  $    $  $  $  $  $  $98,862 
License revenue(44)         1,100      1,100  1,056 
Total revenues98,818          1,100      1,100  99,918 
Operating expenses:                   
Cost of products8,463        (46)       (46) 8,417 
Research and development expenses13,998                  13,998 
Selling, general and administrative expenses24,241                  24,241 
Intangible asset amortization1,128  (1,128)             (1,128)  
Loss (gain) - changes in fair value of related party contingent consideration(20,201)           20,201  18,132  38,333  18,132 
Restructuring costs3,722      (3,722)         (3,722)  
Total operating expenses31,351  (1,128)   (3,722) (46)   20,201  18,132  33,437  64,788 
Operating (loss) income67,467  1,128    3,722  46  1,100  (20,201) (18,132) (32,337) 35,130 
Investment and other income (expense), net1,585    (6)           (6) 1,579 
Interest expense, net(526)                 (526)
Other expense (income) - changes in fair value of related party payable2,220            (2,220) (2,465) (4,685) (2,465)
(Loss) income before income taxes70,746  1,128  (6) 3,722  46  1,100  (22,421) (20,597) (37,028) 33,718 
Income tax (benefit) provision15,909  402      17    (1,269) (1,307) (2,157) 13,752 
Net (loss) income$54,837  $726  $(6) 3,722  $29  $1,100  $(21,152) $(19,290) $(34,871) $19,966 
                    
Net income (loss) per share - diluted(1)$1.29  $0.02  $  0.09  $  $0.03  $(0.50) $(0.45) $(0.82) $0.47 
Weighted average number of shares outstanding - diluted42,625  42,625  42,625  42,625  42,625  42,625  42,625  42,625  42,625  42,625 

(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.

Tuesday, August 7, 2018 - 07:30