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Avadel Pharmaceuticals Reports Fourth Quarter and Full Year 2016 Results

19:00 EST 6 Mar 2017 | Globe Newswire

Strong Fourth Quarter Revenues of $43.1 Million Drive Full Year Revenues of $150.2 Million

Reaffirms 2017 Revenue Guidance of $170 - $200 Million and Adjusted EPS of $0.20 - $0.35

DUBLIN, Ireland, March 07, 2017 (GLOBE NEWSWIRE) -- Avadel Pharmaceuticals plc (NASDAQ:AVDL) today announced its financial results for the fourth quarter and full year 2016.

Highlights Include:

  • Total revenues for fourth quarter and full year 2016 were $43.1 million and $150.2 million, compared to $44.6 million and $173.0 million in the prior year periods.

  • GAAP net income for the fourth quarter was $4.7 million, or $0.11 per diluted share, compared to GAAP net income of $73.5 million, or $1.69 per diluted share, during the same period last year. GAAP net loss for the full year 2016 was $41.3 million or $1.00 per diluted share compared to GAAP net income of $41.8 million or $0.96 per diluted share during the same period last year.

  • Adjusted net income for the fourth quarter was $0.1 million, or $0.00 per diluted share, compared to an adjusted net income of $10.8 million, or $0.25 per diluted share, during the same period last year. (1)

  • Cash and marketable securities at December 31, 2016 were $154.2 million, up from $149.7 million, at September 30, 2016 and $144.8 million at December 31, 2015. 

Michael Anderson, Avadel's Chief Executive Officer, remarked, “We hit a number of milestones during 2016, including the approval and successful launch of our third hospital product, Akovaz®, and in particular during the fourth quarter, we reached an agreement with the FDA on our special protocol assessment for our REST-ON Phase III clinical trial, began enrollment and dosing of patients, and ended the year by redomiciling from France to Ireland and changing our company name in the process. Although it is still early in the enrollment process, REST-ON remains on track, and the successful completion of our trial continues to be a primary objective in 2017.”

Mike Kanan, Avadel's Chief Financial Officer, said, “We are pleased to report strong fourth quarter revenues, which allowed us to finish 2016 above the top end of guidance with $150.2 million in total revenues. A key contributing factor to our strong financial performance was the ability to maintain stable price and share across our branded hospital products, Bloxiverz® and Vazculep®, while successfully launching our third product Akovaz®. We estimate that we exited the quarter and year with approximately 27% of the 7.5 million vial per year ephedrine market, as was our goal. Despite the recent introduction of a second competitor, as we have demonstrated in the past with our other products, we expect to secure and retain our requisite share of the market.”

Kanan continued, “I'm also pleased to report that our cash and marketable securities increased $9.4 million to $154.2 million at December 31, 2016 from $144.8 million at December 31, 2015. We continue to focus on generating cash and have ample liquidity to execute our strategy, including completion of the REST-ON trial and investment in other growth initiatives.”

Fourth Quarter 2016 Results

The Company generated revenues during the fourth quarter 2016 of $43.1 million, compared to $44.6 million during the same period last year. On a GAAP basis, the Company recorded net income of $4.7 million during the fourth quarter 2016, or $0.11 per diluted share, compared to net income of $73.5 million, or $1.69 per diluted share, for the same period last year.   Included in the net income for the fourth quarter 2016 were $3.3 million of gains related to changes in the fair value of related party contingent consideration and related party payables compared to $55.8 million of such gains in the same period last year. Adjusted net income for the fourth quarter was $0.1 million, or $0.00 per diluted share, compared to an adjusted net income of $10.8 million, or $0.25 per diluted share, during the same period last year.(1)  The decline in adjusted net income and adjusted diluted EPS from the previous year was primarily due to lower product sales resulting from increased competition for Bloxiverz®, our neostigmine product, higher SG&A from increased headcount and one-time cross border merger related expenses plus higher R&D spend on the REST-ON Phase III clinical 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.

2017 Guidance

“We are reaffirming the guidance we issued in January 2017 of full year 2017 revenue in the range of $170 to $200 million and adjusted EPS of between $0.20 and $0.35 per diluted share.  Although a second Akovaz® competitor has recently launched, we feel at this time it is premature to modify our full year 2017 guidance.  We expect R&D spending be in the range of $40 and $50 million and our full year adjusted tax rate to fall in the range of 70% - 80%,” commented Mike Kanan.

Conference Call

A conference call to discuss these results has been scheduled for Tuesday, March 7, 2017 at 10:00 a.m. ET. 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 69283135. A live audio webcast and accompanying slides can be accessed by visiting the “News & Events” page of the Company’s Investors website at www.avadel.com. A replay of the webcast will be archived on Avadel’s website for 90 days following the event.

About REST-ON Phase III Clinical Trial

REST-ON is a double-blind, randomized, placebo controlled study of 264 patients to assess the efficacy and safety of a once nightly formulation of sodium oxybate for extended-release oral suspension for the treatment of excessive daytime sleepiness and cataplexy in patients suffering from narcolepsy. For more information, please visit clinicaltrial.avadel.com.

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 in-licensing / acquiring new products; ultimately, helping patients adhere to their prescribed medical treatment and see better results. Avadel currently markets products in the hospital and primary care spaces. The Company is headquartered in Dublin, Ireland with operations in St. Louis, Missouri, United States and Lyon, France. For more information, please visit www.avadel.com.

Safe Harbor: This release may include “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. All statements herein that are not clearly historical in nature are forward-looking, and the words “anticipate, “assume,” “believe,” “expect,” “estimate,” “plan,” “will,” “may,” and the negative of these and similar expressions generally identify forward-looking statements. All forward-looking statements involve risks, uncertainties and contingencies, many of which are beyond Avadel's control and could cause actual results to differ materially from the results contemplated in such forward-looking statements. These risks, uncertainties and contingencies include the risks relating to: our dependence on a small number of products and customers for the majority of our revenues; the possibility that our Bloxiverz®,Vazculep® and 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 product and apply for FDA approval of such product before us; our dependence on the performance of third parties in partnerships or strategic alliances for the commercialization of some of our products; the possibility that our products may not reach the commercial market or gain market acceptance; our need to invest substantial sums in research and development in order to remain competitive; our dependence on certain single providers for development of several of our drug delivery platforms and products; our dependence on a limited number of suppliers to manufacture our products and to deliver certain raw materials used in our products; the possibility that our competitors may develop and market technologies or products that are more effective or safer than ours, or obtain regulatory approval and market such technologies or products before we do; the challenges in protecting the intellectual property underlying our drug delivery platforms and other products; our dependence on key personnel to execute our business plan; the amount of additional costs we will incur to comply with U.S. securities laws as a result of our ceasing to qualify as a foreign private issuer; and the other risks, uncertainties and contingencies described in the Company's filings with the U.S. Securities and Exchange Commission, including our annual report on Form 10-K for the year ended December 31, 2015, all of which filings are also available on the Company's website. Avadel undertakes no obligation to update its forward-looking statements as a result of new information, future events or otherwise, except as required by law.

Non-GAAP Disclosures and Adjustments

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 a comparison of its current and historical results would be difficult if the disclosures were limited to financial measures prepared only in accordance with generally accepted accounting principles (GAAP) in the U.S.  In addition to reporting its financial results in accordance with GAAP, Avadel reports certain non-GAAP results that exclude, if any, fair value remeasurements of its contingent consideration, impairment of intangible assets, amortization of intangible assets, foreign exchange gains and losses on assets and liabilities denominated in foreign currency, but includes the operating cash flows plus any unpaid accrued amounts associated with the  contingent consideration, in order to supplement investors' and other readers' understanding and assessment of the Company's financial performance.  The Company's management uses these non-GAAP measures internally for forecasting, budgeting and measuring its operating performance.  Investors and other readers should review the related GAAP financial measures and the reconciliation of non-GAAP measures to their most closely applicable GAAP measure set forth below and should consider non-GAAP measures only as a supplement to, not as a substitute for or as a superior measure to, measures of financial performance prepared in accordance with GAAP. The table provided within the following “Supplemental Information” section reconciles GAAP net income and loss and diluted earnings or loss per share to the corresponding adjusted amounts.

1Non-GAAP financial measure. 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.


AVADEL PHARMACEUTICALS PLC
CONSOLIDATED STATEMENTS OF INCOME (LOSS)
(In thousands, except per share data)
     
  Three-Months Ended Twelve-Months Ended
  December 31, December 31,
  2016 2015 2016 2015
         
Revenues:        
Product sales and services $42,364  $43,847  $147,222  $172,288 
License and research revenue 721  721  3,024  721 
Total 43,085  44,568  150,246  173,009 
Operating expenses:        
Cost of products and services sold 2,591  2,937  13,248  11,410 
Research and development 13,476  5,161  34,611  25,608 
Selling, general and administrative 10,688  6,808  44,179  21,712 
Intangible asset amortization 2,970  3,141  13,888  12,564 
Changes in fair value of related party contingent consideration (3,704) (51,079) 49,285  30,957 
Total 26,021  (33,032) 155,211  102,251 
Operating income (loss) 17,064  77,600  (4,965) 70,758 
Investment and other income 555  65  1,635  1,236 
Interest expense (261)   (963)  
Other income (expense) - changes in fair value of related party payable (413) 4,746  (6,548) (4,883)
Foreign exchange gain 1,135  2,498  1,123  10,594 
Income (loss) before income taxes 18,080  84,909  (9,718) 77,705 
Income tax provision 13,346  11,391  31,558  35,907 
Net income (loss) $4,734  $73,518  $(41,276) $41,798 
         
Earnings (loss) per share - basic: $0.11  $1.79  $(1.00) $1.03 
Earnings (loss) per share - diluted: $0.11  $1.69  $(1.00) $0.96 
         
Weighted average number of shares outstanding - basic 41,269  41,125  41,248  40,580 
Weighted average number of shares outstanding - diluted 42,808  43,430  41,248  43,619 


AVADEL PHARMACEUTICALS PLC
CONSOLIDATED BALANCE SHEETS
(In thousands, except per share data) 
   
  As of December 31,
  2016 2015
     
ASSETS    
Current assets:    
Cash and cash equivalents $39,215  $65,064 
Marketable securities 114,980  79,738 
Accounts receivable 17,839  7,487 
Inventories 3,258  3,666 
Research and development tax credit receivable   2,382 
Prepaid expenses and other current assets 5,894  8,064 
Total current assets 181,186  166,401 
Property and equipment, net 3,320  2,616 
Goodwill 18,491  18,491 
Intangible assets, net 22,837  15,825 
Research and development tax credit receivable 1,775   
Income tax deferred charge 10,342  11,581 
Other 7,531  167 
Total assets $245,482  $215,081 
     
LIABILITIES AND SHAREHOLDERS' EQUITY    
Current liabilities:    
Current portion of long-term debt $268  $434 
Current portion of long-term related party payable 34,177  25,204 
Accounts payable 7,105  5,048 
Deferred revenue 2,223  5,121 
Accrued expenses 17,222  9,308 
Income taxes 1,200   
Other 226  133 
Total current liabilities 62,421  45,248 
Long-term debt 547  684 
Long-term related party payable 135,170  97,489 
Other 5,275  2,526 
Total liabilities 203,413  145,947 
     
Shareholders' equity:    
Preferred shares, $0.01 nominal value; 50,000 shares authorized at December 31, 2016, none authorized at December 31, 2015; none issued or outstanding at December 31, 2016 and December 31, 2015, respectively    
Ordinary shares, nominal value of $0.01 and €0.122; 500,000 and 53,178 shares authorized; 41,371 and 41,241 issued and outstanding at December 31, 2016 and 2015, respectively 414  6,331 
Additional paid-in capital 385,020  363,984 
Accumulated deficit (319,800) (278,524)
Accumulated other comprehensive loss (23,565) (22,657)
Total shareholders' equity 42,069  69,134 
Total liabilities and shareholders' equity $245,482  $215,081 


AVADEL PHARMACEUTICALS PLC
CONSOLIDATED STATEMENTS OF CASH FLOWS
(In thousands)
   
  Twelve-Months Ended December 31,
  2016 2015
     
Cash flows from operating activities:    
Net income (loss) $(41,276) $41,798 
Adjustments to reconcile net income (loss) to net cash provided by (used in) operating activities:    
Depreciation and amortization 14,489  13,132 
Loss on disposal of property and equipment 110   
Loss on sale of marketable securities 826  779 
Unrealized foreign currency exchange gain (349) (8,969)
Gains on waiver of research and development grants and other   (1,498)
Remeasurement of related party acquisition-related contingent consideration 49,285  30,957 
Remeasurement of related party financing-related royalty agreements 6,548  4,883 
Change in deferred tax and income tax deferred charge (4,000) 69 
Stock-based compensation expense 14,679  7,741 
Increase (decrease) in cash from:    
Accounts receivable (10,050) (8,440)
Inventories 1,831  3,036 
Prepaid expenses and other current assets 3,412  (684)
Research and development tax credit receivable 397  2,975 
Accounts payable & other current liabilities (434) (8,533)
Deferred revenue (2,923) 3,815 
Accrued expenses 6,764  3,376 
Accrued income taxes 1,778  (393)
Earn-out payments for related party contingent consideration in excess of acquisition-date fair value (20,252)  
Royalty payments for related party payable in excess of original fair value (2,469)  
Other long-term assets and liabilities 535  249 
Net cash provided by operating activities 18,901  84,293 
Cash flows from investing activities:    
Purchases of property and equipment (1,201) (1,629)
Acquisitions of businesses, including cash acquired and other adjustments 628   
Proceeds from sales of marketable securities 71,546  48,308 
Purchases of marketable securities (107,603) (78,409)
Net cash used in investing activities (36,630) (31,730)
Cash flows from financing activities:    
Reimbursement of loans   (4,911)
Reimbursement of conditional R&D grants (277) (747)
Earn-out payments for related party contingent consideration (6,892) (24,526)
Royalty payments for related party payable (1,225) (3,371)
Excess tax benefit from stock-based compensation   2,814 
Cash proceeds from issuance of ordinary shares and warrants 440  6,990 
Net cash used in financing activities (7,954) (23,751)
Effect of exchange rate changes on cash and cash equivalents (166) (3,508)
Net increase (decrease) in cash and cash equivalents (25,849) 25,304 
Cash and cash equivalents - beginning balance 65,064  39,760 
Cash and cash equivalents - ending balance $39,215  $65,064 
Supplemental disclosures of cash flow information:    
Income tax paid $27,180  $42,121 
Interest paid 788  4,738 


AVADEL PHARMACEUTICALS PLC
UNAUDITED SUPPLEMENTAL INFORMATION
(In thousands, except per share data)
     
  Three-Months Ended December 31, Twelve-Months Ended December 31,
Revenues 2016 2015 2016 2015
         
Bloxiverz $16,938  $36,009  $82,896  $150,083 
Vazculep 10,629  7,394  39,796  20,151 
Akovaz 11,263    16,831   
Other 3,534  444  7,699  2,054 
Total product sales and services 42,364  43,847  147,222  172,288 
License and research revenue 721  721  3,024  721 
Total revenues $43,085  $44,568  $150,246  $173,009 


    GAAP to Non-GAAP adjustments for the three-months ended December 31, 2016    
    Exclude Include    
  GAAP Intangible asset amortization Foreign exchange (gain)/loss Cross - border merger impacts Purchase accounting adjustments - FSC Contingent related party payable fair value remeasurements Contingent related party payable paid/accrued Total adjustments Adjusted GAAP
                   
Revenues:                  
Product sales and services $42,364  $  $  $  $  $  $  $  $42,364 
License and research revenue 721                721 
Total 43,085                43,085 
Operating expenses:                  
Cost of products and services sold 2,591        1,019      1,019  3,610 
Research and development 13,476                13,476 
Selling, general and administrative 10,688                10,688 
Intangible asset amortization 2,970  (2,970)           (2,970)  
Changes in fair value of related party contingent consideration (3,704)         3,704  7,645  11,349  7,645 
Total 26,021  (2,970)     1,019  3,704  7,645  9,398  35,419 
Operating income (loss) 17,064  2,970      (1,019) (3,704) (7,645) (9,398) 7,666 
Investment and other income 555                555 
Interest expense (261)               (261)
Other expense - changes in fair value of related party payable (413)         413  (1,018) (605) (1,018)
Foreign exchange gain 1,135    (1,135)         (1,135)  
Income (loss) before income taxes 18,080  2,970  (1,135)   (1,019) (3,291) (8,663) (11,138) 6,942 
Income tax provision (benefit) 13,346  1,066    (6,754) (366) 82  (499) (6,471) 6,875 
Net income (loss) $4,734  $1,904  $(1,135) $6,754  $(653) $(3,373) $(8,164) $(4,667) $67 
                   
Net income (loss) per share - diluted(1) $0.11  $0.04  $(0.03) $0.16  $(0.02) $(0.08) $(0.19) $(0.11) $ 
Weighted average number of shares outstanding - diluted 42,808  42,808  42,808  42,808  42,808  42,808  42,808  42,808  42,808 

(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, 2015    
    Exclude Include    
  GAAP Intangible asset amortization Foreign exchange (gain)/loss Contingent related party payable fair value remeasurements Contingent related party payable paid/accrued Total adjustments Adjusted GAAP
               
Revenues:              
Product sales and services $43,847  $  $  $  $  $  $43,847 
License and research revenue 721            721 
Total 44,568            44,568 
Operating expenses:              
Cost of products and services sold 2,937            2,937 
Research and development 5,161            5,161 
Selling, general and administrative 6,808            6,808 
Intangible asset amortization 3,141  (3,141)       (3,141)  
Changes in fair value of related party contingent consideration (51,079)     51,079  8,158  59,237  8,158 
Total (33,032) (3,141)   51,079  8,158  56,096  23,064 
Operating income (loss) 77,600  3,141    (51,079) (8,158) (56,096) 21,504 
Investment and other income 65            65 
Interest expense              
Other expense - changes in fair value of related party payable 4,746      (4,746) (1,123) (5,869) (1,123)
Foreign exchange gain 2,498    (2,498)     (2,498)  
Income (loss) before income taxes 84,909  3,141  (2,498) (55,825) (9,281) (64,463) 20,446 
Income tax provision (benefit) 11,391  1,099  (749) (1,661) (393) (1,704) 9,687 
Net income (loss) $73,518  $2,042  $(1,749) $(54,164) $(8,888) $(62,759) $10,759 
               
Net (loss) income per share - diluted (1) $1.69  $0.05  $(0.04) $(1.25) $(0.20) $(1.45) $0.25 
Weighted average number of shares outstanding - diluted 43,430  43,430  43,430  43,430  43,430  43,430  43,430 

(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, 2016    
    Exclude Include    
  GAAP Intangible asset amortization Foreign exchange (gain)/loss Cross - border merger impacts Purchase accounting adjustments - FSC Contingent related party payable fair value remeasurements Contingent related party payable paid/accrued Total adjustments Adjusted GAAP
                   
Revenues:                  
Product sales and services $147,222  $  $  $  $  $  $  $  $147,222 
License and research revenue 3,024                3,024 
Total 150,246                150,246 
Operating expenses:                  
Cost of products and services sold 13,248        (506)     (506) 12,742 
Research and development 34,611                34,611 
Selling, general and administrative 44,179                44,179 
Intangible asset amortization 13,888  (13,888)           (13,888)  
Changes in fair value of related party contingent consideration 49,285          (49,285) 26,966  (22,319) 26,966 
Total 155,211  (13,888)     (506) (49,285) 26,966  (36,713) 118,498 
Operating income (loss) (4,965) 13,888      506  49,285  (26,966) 36,713  31,748 
Investment and other income 1,635                1,635 
Interest expense (963)               (963)
Other expense - changes in fair value of related party payable (6,548)         6,548  (3,636) 2,912  (3,636)
Foreign exchange gain 1,123    (1,123)         (1,123)  
Income (loss) before income taxes (9,718) 13,888  (1,123)   506  55,833  (30,602) 38,502  28,784 
Income tax provision (benefit) 31,558  4,986    (6,754) 182  3,068  (1,667) (185) 31,373 
Net income (loss) $(41,276) $8,902  $(1,123) $6,754  $324  $52,765  $(28,935) $38,687  $(2,589)
                   
Net (loss) income per share - diluted (1) $(1.00) $0.22  $(0.03) $0.16  $0.01  $1.28  $(0.70) $0.94  $(0.06)
Weighted average number of shares outstanding - diluted 41,248  41,248  41,248  41,248  41,248  41,248  41,248  41,248  41,248 

(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, 2015    
    Exclude Include    
  GAAP Intangible asset amortization Foreign exchange (gain)/loss Contingent related party payable fair value remeasurements Contingent related party payable paid/accrued Total adjustments Adjusted GAAP
               
Revenues:              
Product sales and services $172,288  $  $  $  $  $  $172,288 
License and research revenue 721            721 
Total 173,009            173,009 
Operating expenses:              
Cost of products and services sold 11,410            11,410 
Research and development 25,608            25,608 
Selling, general and administrative 21,712            21,712 
Intangible asset amortization 12,564  (12,564)       (12,564)  
Changes in fair value of related party contingent consideration 30,957      (30,957) 32,081  1,124  32,081 
Total 102,251  (12,564)   (30,957) 32,081  (11,440) 90,811 
Operating income (loss) 70,758  12,564    30,957  (32,081) 11,440  82,198 
Investment and other income 1,236            1,236 
Interest expense              
Other expense - changes in fair value of related party payable (4,883)     4,883  (4,414) 469  (4,414)
Foreign exchange gain 10,594    (10,594)     (10,594)  
Income (loss) before income taxes 77,705  12,564  (10,594) 35,840  (36,495) 1,315  79,020 
Income tax provision (benefit) 35,907  4,397  (3,178) 1,709  (1,545) 1,383  37,290 
Net income (loss) $41,798  $8,167  $(7,416) $34,131  $(34,950) $(68) $41,730 
               
Net (loss) income per share - diluted (1) $0.96  $0.19  $(0.17) $0.78  $(0.80) $  $0.96 
Weighted average number of shares outstanding - diluted 43,619  43,619  43,619  43,619  43,619  43,619  43,619 

(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.

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

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