Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Selling, general and administrative expense increased by $11.7 million, or 58%, during the three months ended September 30, 2018, compared to the three months ended September 30, 2017.  The increase was primarily attributable to Nalpropion’s acquisition of Orexigen, which resulted in selling, general and administrative expenses of $17.1 million.  This increase was partially offset by lower sales force-related expenses of $2.6 million due to the restructuring announced in January 2018, and lower marketing and selling expenditures of $1.0 million related primarily to the loss of exclusivity of Treximet.

Research and development expense increased by $1.4 million during the three months ended September 30, 2018, compared to the three months ended September 30, 2017, and is primarily attributable to Nalpropion’s acquisition of Orexigen, which resulted in research and development costs of $1.5 million.  This increase was partially offset by the discontinuation of certain Zohydro-related research projects.

Net loss was $11.8 million, or $0.89 per basic and diluted share, for the three months ended September 30, 2018, compared to net income of $6.4 million, or $0.57 per basic and $0.42 per diluted share, in the same period last year.

Adjusted EBITDA was $(0.7) million for the three months ended September 30, 2018, compared to adjusted EBITDA of $11.6 million for three months ended September 30, 2017, a decrease of $12.3 million.

Nine months Ended September 30, 2018 vs. September 30, 2017

For the nine months ended September 30, 2018, net revenues were $86.4 million, a 17% decrease from the $104.5 million in the nine months ended September 30, 2017.  A summary of net revenues is outlined below:

     

Nine Months Ended

           
Amounts in ($000's)    

September 30,

   

Increase

     
     

2018

   

2017

   

(Decrease)

   

Percent

Net Revenues:                        
  Contrave   $   16,418   $   -    $   16,418       *
  Treximet       17,221       50,412       (33,191 )     -66 %
  Treximet AG       7,135       -        7,135       *
  Zohydro ER       21,937       17,955       3,982       22 %
  Silenor       17,299       15,580       1,719       11 %
  Other products       5,738       20,335       (14,597 )     -72 %
Net product revenues       85,748       104,282       (18,534 )     -18 %
  Co-promotion and other revenue       635       245       390       159 %
Total net revenues   $   86,383   $   104,527   $   (18,144 )     -17 %
* Not Meaningful                        

The increase in Contrave net revenues of $16.4 million during the nine months ended September 30, 2018, was attributable to Nalpropion’s acquisition of Orexigen.

Treximet brand net revenues decreased by $33.2 million, or 66%, during the nine months ended September 30, 2018, compared to the nine months ended September 30, 2017, due to the loss of exclusivity of Treximet in February 2018, as the Company experienced generic competition.

Treximet AG net revenues were $7.1 million during the nine months ended September 30, 2018, due to its launch on February 15, 2018.

Zohydro ER net revenues increased by $4.0 million, or 22%, during the nine months ended September 30, 2018, compared to the nine months ended September 30, 2017.  The increase was due to an increase in net price of $1.8 million (primarily related to favorable gross-to-net accrual rates) and sales volume of $2.2 million. Sales volume was favorably impacted by the relaunch of the 20mg strength of Zohydro ER during the first quarter of 2018.

Silenor net revenues increased by $1.7 million, or 11%, during the nine months ended September 30, 2018, compared to the nine months ended September 30, 2017. The increase was due to sales volume of $2.1 million, partially offset by a decrease in net price of $0.4 million (primarily related to unfavorable gross-to-net accrual rates).

Net product revenues – other decreased by $14.6 million, or 72%, during the nine months ended September 30, 2018, compared to the nine months ended September 30, 2017 primarily due to the discontinuation of products no longer sold by the Company. 

Cost of product sales decreased by $4.8 million, or 15%, during the nine months ended September 30, 2018, compared to the nine months ended September 30, 2017. The decrease in cost of product sales was due primarily to a $7.1 million decrease in costs associated with Treximet brand as a result of lower volume due to the entry of generic competition, as well as a $6.0 million decrease in costs associated with the Company’s other product revenue category.  These decreases were partially offset by an increase in costs of product sales attributable to Nalpropion’s acquisition of Contrave of $5.4 million and increased Zohydro ER, Treximet AG and Silenor product costs of $1.8 million, $0.6 million and $0.5 million, respectively, due to increased volume. 

Selling, general and administrative expense increased by $8.0 million, or 13%, during the nine months ended September 30, 2018, compared to the nine months ended September 30, 2017.  The increase was primarily attributable Nalpropion’s acquisition of Orexigen, which resulted in selling, general and administrative expenses of $17.1 million.  The increase was partially offset by lower sales force-related expenses of $7.1 million due to the restructuring announced in January 2018, lower marketing and selling expenditures of $2.7 million related primarily due to the loss of exclusivity on branded Treximet, as well as $1.7 million of lower spend across numerous areas, partially offset by higher legal fees of $2.4 million related primarily to patent defense and legal settlements.

Research and development expense increased by $0.8 million during the nine months ended September 30, 2018, compared to the nine months ended September 30, 2017, due primarily to Nalpropion’s acquisition of Orexigen, which resulted in research and development costs of $1.5 million.  This increase was partially offset by the discontinuation of certain Zohydro-related research projects.

Net loss was $43.9 million, or $3.55 per basic and diluted share, for the nine months ended September 30, 2018, compared to a net loss of $44.7 million, or $4.31 per basic and diluted share, in the same period last year.

Adjusted EBITDA was $1.6 million for the nine months ended September 30, 2018, compared to adjusted EBITDA of $17.0 million for the nine months ended September 30, 2017, a decrease of $15.4 million.

Liquidity

As of September 30, 2018, Pernix, consolidated with Nalpropion, had cash and cash equivalents of $24.5 million, as compared to $32.8 million as of December 31, 2017, and borrowing availability of $6.8 million under the ABL Facility. Excluding Nalpropion, Pernix had cash and cash equivalents of $18.2 million as of September 30, 2018 and total liquidity of $25.0 million. Pernix’s cash included $12.2 million of cash received related to Contrave sales. For more detailed information, please refer to the “Liquidity and Capital Resources” section of the Company’s Quarterly Report on Form 10-Q for the Quarterly Period ended September 30, 2018.

In mid-October, Pernix received letters from Nasdaq notifying the Company that it is no longer in compliance with certain continued listing requirements of the Nasdaq Global Market and has until mid-April 2019 to address these deficiencies.

The Company is in the process of analyzing various alternatives to address its liquidity and capital structure. For more detailed information, please refer to the “Liquidity and Capital Resources” section of the Company’s Quarterly Report on Form 10-Q for the Quarterly Period ended September 30, 2018.

Conference Call

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Webcast: 

Thursday, November 8

4:30 PM ET

866-548-4713

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9549306

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About Pernix Therapeutics Holdings, Inc.

Pernix Therapeutics Holdings, Inc. (the “Company”) is the parent company of Pernix Therapeutics, LLC, a specialty pharmaceutical business focused on acquiring and commercializing prescription drugs, primarily for the U.S. market.  Pernix Therapeutics, LLC is currently focused on the therapeutic areas of Pain and Neurology, and has an interest in expanding into additional specialty segments.  Pernix Therapeutics, LLC promotes branded products to physicians through its internal sales force.  The Company’s wholly-owned subsidiaries, Macoven Pharmaceuticals, L.L.C., and Cypress Pharmaceuticals, Inc., market a portfolio of generic products.  

To learn more about Pernix Therapeutics, visit u">>www.pernixtx.com.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Statements including words such as “estimate,” “plan,” “project,” “forecast,” “intend,” “expect,” “anticipate,” “believe,” “seek,” “target” or similar expressions are forward-looking statements.  These statements reflect the Company’s current views, expectations and beliefs concerning future events.  In addition, any statements related to Pernix’s consideration of strategic alternatives and future strategy and plans with respect to its business contained herein are forward-looking statements. Such plans, expectations and statements are as to future events and are not to be viewed as facts, and reflect various assumptions of management of the Company and are subject to significant business, financial, economic, operating, competitive, litigation and other risks and uncertainties and contingencies (many of which are difficult to predict and beyond the control of the Company) that could cause actual results to differ materially from the statements included herein. The inclusion of forward-looking statements should not be regarded as a representation by Pernix that any of its plans will be achieved.  Investors should note that many factors, including those more fully described in Pernix’s filings with the Securities and Exchange Commission (“SEC”) (including, but not limited to, its Annual Report on Form 10-K for the year ended December 31, 2017 and its Quarterly Report on Form 10-Q for the Quarterly Period ended September 30, 2018 and subsequent filings with the SEC), could affect the Company’s future financial results and could cause actual results to differ materially from those expressed in forward-looking statements, such as those contained in this press release.  The forward-looking statements in this press release are qualified by risk factors identified by the Company.  These risk factors, individually or in the aggregate, could cause our actual results to differ materially from expected and historical results.  You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  The Company assumes no obligation to publicly update any forward-looking statements, whether as a result of new information, future developments or otherwise.

CONTACT

Investor Relations

Bob Yedid

LifeSci Advisors, LLC

u">>Bob@LifeSciAdvisors.com

PERNIX THERAPEUTICS HOLDINGS, INC. AND SUBSIDIARIES

Condensed Consolidated Balance Sheets

(In thousands, except share and per share data)

(Unaudited)

     

September 30,

   

December 31,

Assets

   

2018

     

2017

 

Current assets:

           
   Cash and cash equivalents   $   24,511     $   32,820  
   Accounts receivable, net       66,443         45,317  
   Inventory, net       17,788         5,396  
   Prepaid expenses and other current assets       11,935         8,628  
   Income tax receivable     45         123  

     Total current assets

      120,722         92,284  
             
Property and equipment, net       1,000         752  
Goodwill       17,572         12,100  
Intangible assets, net       133,649         96,606  
Other       1,827         2,263  

  Total assets

  $   274,770     $   204,005  

Liabilities and Stockholders' Deficit

           

Current liabilities:

           
  Accounts payable   $   11,302     $   7,911  
   Accrued personnel expenses       5,181         5,748  
   Accrued allowances       71,698         56,309  
  Other accrued expenses       10,148         6,909  
   Interest payable       6,381         10,612  
  Treximet Secured Notes – current, net       -         3,664  
  Other liabilities - current       6,901         2,648  

    Total current liabilities

      111,611         93,801  
             
Term loan       41,250         -  
Convertible notes – long-term, net       67,823         65,194  
Exchangeable notes – long-term, net       10,030         7,975  
Delayed draw term loan - long-term, net       37,805         27,248  
Derivative liability       54         93  
Contingent consideration       1,501         1,358  
Treximet Secured Notes – long-term, net       151,364         163,887  
Credit facility       14,185         14,185  
Deferred revenue       10,840         -  
Arbitration award       -         2,000  
Other liabilities - long-term       589         2,521  

  Total liabilities

      447,052         378,262  

Commitments and contingencies

           

Stockholders' deficit:

           
  Preferred stock, $0.01 par value; 8,500,000 and 10,000,000 shares authorized            
  at September 30, 2018 and December 31, 2017; no shares issued and

  outstanding at September 30, 2018 and December 31, 2017

      -         -  
  Series C convertible preferred stock, $0.01 par value, authorized 1,500,000 shares;            
  81,000 shares issued and outstanding at September 30, 2018       1         -  
  Common stock, $0.01 par value, 140,000,000 shares authorized, 13,957,733            
  and 11,841,173 shares issued and outstanding at September 30, 2018 and            
  December 31, 2017, respectively       140         119  
  Additional paid-in capital       274,458         261,158  
  Accumulated other comprehensive loss       85         -  
  Accumulated deficit       (479,476 )       (435,534 )

Total Pernix stockholders' deficit

      (204,792 )       (174,257 )
  Noncontrolling interests       32,510         -  

    Total stockholders’ deficit

      (172,282 )       (174,257 )

      Total liabilities and stockholders’ deficit

  $   274,770     $   204,005  

PERNIX THERAPEUTICS HOLDINGS, INC. AND SUBSIDIARIES

Condensed Consolidated Statements of Operations

(In thousands, except per share data)

(Unaudited)

   

 

Three Months Ended

 

 

 

Nine Months Ended

   

 

September 30,

 

 

 

September 30,

   

 

2018

 

 

 

2017

 

 

 

 

2018

 

 

 

2017

 
                           

Net revenues

  $   37,156      $   40,469       $   86,383      $   104,527  

Costs and operating expenses:

                         
  Cost of product sales       11,823         10,580           26,353         31,113  
  Selling, general and administrative expense       31,872         20,226           67,412         59,519  
  Research and development expense       1,524         99           1,534         709  
  Depreciation and amortization expense       2,391         18,214           13,686         54,976  
  Change in fair value of contingent consideration       -         884           143         344  
  Loss from disposal and impairments of assets       75         25         75          25  
  Gain from legal settlement       -         (10,476 )               (10,476 )
  Restructuring costs       (2 )       (97 )         1,212         34  
                           

  Total costs and operating expenses

      47,683         39,455           110,415         136,244  
                           

Income (loss) from operations

      (10,527 )       1,014           (24,032 )       (31,717 )
                           

Other income (expense):

                         
  Interest expense, net       (10,073 )       (9,323 )         (29,063 )       (27,491 )
  Gain on sale of assets       -         -           446         -  
  Change in fair value of derivative liability       18         46           39         (38 )
  Gain from exchange of debt       137          14,650         137          14,650  
  Foreign currency transaction (loss) gain       (843 )       -            (864 )     0  

  Total other income (expense), net

      (10,761 )       5,373           (29,305 )       (12,879 )
                           

Income (loss) before income tax expense

      (21,288 )       6,387           (53,337 )       (44,596 )
Income tax expense     61         27           109         122  

Net income (loss)

  $   (21,349 )    $   6,360       $   (53,446 )    $   (44,718 )
Adjust: Net loss attributable to noncontrolling interests       9,504         -           9,504         -  

Net income (loss) attributable to common stockholders

      (11,845 )       6,360           (43,942 )       (44,718 )

 

                         
Net income (loss) per common share attributable to common stockholders:                    
  Basic   $   (0.89 )    $   0.57       $   (3.55 )    $   (4.31 )
  Diluted   $   (0.89 )   $   0.42        $   (3.55 )   $   (4.31 )
                           
                           
Weighted-average common shares outstanding:                          
  Basic       13,301         11,117           12,377         10,387  
  Diluted       13,301         16,520           12,377         10,387  
                           

Non-GAAP Financial Measures

To supplement our financial results determined by GAAP, we have disclosed in the table below adjusted earnings before interest, taxes, depreciation and amortization (EBITDA). 

Adjusted EBITDA is a non-GAAP financial measure that excludes the impact of certain items and, therefore, has not been calculated in accordance with GAAP.  This non-GAAP financial measure excludes from net loss: interest expense; depreciation and amortization; income tax expense; inventory step-up amortization, selling, general and administrative adjustments; gain from sale of non-core assets; change in fair value of contingent consideration; loss from disposal and impairment of assets; gain from exchange of debt; change in fair value of derivative liability; restructuring costs; gain from legal settlement and foreign currency transactions.  In addition, from time to time in the future there may be other items that we may exclude for the purposes of our use of adjusted EBITDA; likewise, we may in the future cease to exclude items that we have historically excluded for the purpose of adjusted EBITDA.  We believe that adjusted EBITDA provides meaningful supplemental information regarding our operating results because it excludes or adjusts amounts that management and the board of directors do not consider part of core operating results or that are non-recurring when assessing the performance of the organization.  We believe that inclusion of adjusted EBITDA provides consistency and comparability with past reports of financial results and provides consistency in calculations by outside analysts reviewing our results.  Accordingly, we believe that adjusted EBITDA is useful to investors in allowing for greater transparency of supplemental information used by management.

We believe that these non-GAAP financial measures are helpful in understanding our past financial performance and potential future results, but there are limitations associated with the use of these non-GAAP financial measures.  These non-GAAP financial measures are not prepared in accordance with GAAP, do not reflect a comprehensive system of accounting and may not be completely comparable to similarly titled measures of other companies due to potential differences in the exact method of calculation between companies. Adjustment items that are excluded from our non-GAAP financial measures can have a material impact on net earnings.  As a result, these non-GAAP financial measures have limitations and should not be considered in isolation from, or as a substitute for, net loss, cash flow from operations or other measures of performance prepared in accordance with GAAP.  We compensate for these limitations by using these non-GAAP financial measures as a supplement to GAAP financial measures and by reconciling the non-GAAP financial measure to its most comparable GAAP financial measure.  Investors are encouraged to review the reconciliations of the non-GAAP financial measure to its most comparable GAAP financial measure that is included below in this Quarterly Report on Form 10-Q.

Reconciliation of GAAP reported net loss to adjusted EBITDA is as follows (in thousands):

         

Three Months Ended

   

Nine Months Ended

         

September 30,

   

September 30,

         

2018

     

2017

     

2018

     

2017

 
Net income (loss) attributable to common stockholders       $   (11,845 )   $   6,360     $   (43,942 )   $   (44,718 )
Add: Net lossattributable to noncontrolling interests           (9,504 )       -         (9,504 )       -  
Adjustments:                            
  Interest expense, net           10,073         9,323         29,063         27,491  
  Depreciation and amortization           2,422         18,243         13,773         55,064  
  Income tax expense         61         27         109         122  
EBITDA           (8,793 )       33,953         (10,501 )       37,959  
  Inventory step-up amortization(1)           2,239         -         2,239         -  
  Selling, general and administrative adjustments (2)           5,059         1,985         8,190         3,720  
  Gain from sale of non-core asset (3)           -         -         (446 )       -  
  Change in fair value of contingent consideration  (4)           -         884         143         344  
  Loss from disposal and impairment of assets (5)           75         25         75         25  
  Gain from exchange of debt (6)           (137 )       (14,650 )       (137 )       (14,650 )
  Change in fair value of derivative liability  (7)           (18 )       (46 )       (39 )       38  
  Restructuring costs (8)           (2 )       (97 )       1,212         34  
  Gain from legal settlement (9)           -         (10,476 )       -         (10,476 )
  Foreign currency transaction (gain) loss (10)           843         -         864         -  
Adjusted EBITDA       $   (734 )   $   11,578     $   1,600     $   16,994  

                                               

(1) Excludes inventory step-up amortization recorded as part of Nalpropion’s acquisition of Orexigen.

        

(2) Excludes deal costs of $4.6 million and $1.3 million; stock compensation expense of $0.4 million and $0.5 million; severance expense of $16,000 and $0.2 million; and litigation settlement expenses of $25,000 and $20,000 for the three months ended September 30, 2018 and 2017, respectively.  Also excludes deal costs of $5.4 million and $1.5 million; stock compensation expense of $1.3 million and $1.9 million; severance expense of $0.1 million and $0.2 million; and arbitration and litigation settlement expenses of $1.3 million and $38,000 for the nine months ended September 30, 2018 and 2017, respectively.

        

(3) Excludes the gain from the sale of certain obsolete equipment.

(4) Excludes loss from change in fair value of contingent consideration related to the 2015 acquisition of Zohydro ER and is linked to the achievement of certain net sales targets. Any change in fair values between the reporting dates is recognized in the condensed consolidated statements of operations.   

(5) Excludes loss from impairment of other assets.     

(6) Excludes $0.1 million gain related to the Exchange Transaction and the Equitization Transaction in the three and nine months ended September 2018.  For the three and nine months ended September 30, 2017, excludes a $14.7 million gain related to the July 2017 financing transactions in which certain holders of the 4.25% Convertible Notes exchanged $51.8 million in principal notes for $36.2 million in Exchangeable Notes. 

(7) Excludes changes in fair value of derivative liability consideration. We are required to separate the conversion option in the 4.25% Convertible Notes under ASC 815, Derivatives and Hedging.  We recorded the bifurcated conversion option valued at $28.5 million at issuance, as a derivative liability, which created additional discount on the debt.  The derivative liability is marked to market through the other income (expense) section on the condensed consolidated statements of operations for each reporting period.

(8) Excludes the cost related to the initiative to restructure our sales force and operations for the three and nine months ended September 30, 2018 and 2017.   

(9) Excludes $10.5 million gain from Pernix and GSK amended settlement agreement resulting from Amendment NO. 2 to the Interim Settlement Agreement with GSK under which Pernix paid approximately $6.7 million to GSK (potentially up to $8.7 million), which is a reduction of up to approximately $14.5 million from the initial settlement agreement.        

(10) Excludes losses on foreign currency transactions primarily related to Nalpropion’s operations.

 

 

 

 

Source : https://finance.yahoo.com/news/pernix-therapeutics-reports-third-quarter-210100336.html

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Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Source:Yahoo Finance

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Source:Seeking Alpha

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Source:Business Wire

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Source:GlobeNewswire

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Source:Yahoo Finance

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Source:StreetInsider

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Source:GlobeNewswire

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Source:Seeking Alpha

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update

Source:Business Wire

Pernix Therapeutics Reports First Quarter 2017 Financial Results And Provides Business Update