Akorn Reports Third Quarter 2009 Financial Results; Launches Two New Products: Ketorolac Tromethamine Ophthalmic and Hydralazine HCL

Tue Nov 10, 2009 1:01am EST
 
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http://www.businesswire.com/news/home/20091109006783/en

LAKE FOREST, Ill.--(Business Wire)--
Akorn, Inc. (NASDAQ: AKRX) a specialty pharmaceutical company, today reported
financial results for the third quarter ended September 30, 2009. 

Consolidated revenue for the third quarter 2009 was $19.4 million, versus $31.9
million in the third quarter 2008 representing a decrease of approximately 39%.
The decrease was due to lower sales of tetanus-diphtheria ("Td") and flu
vaccines and overall lower sales to wholesalers as part of an effort to reduce
wholesaler inventory levels. Ophthalmic segment revenue decreased by $0.3
million or 6%, primarily due to targeted wholesaler reductions in stocking
levels. Hospital drugs and injectables segment revenue decreased $3.1 million or
49%, reflecting the targeted wholesaler reduction in stocking levels. Vaccine
revenue for this quarter decreased by $8.5 million versus the prior year period
primarily due to stronger third quarter 2008 sales resulting from the
introduction of a single dose vial Td vaccine and a flu vaccine supply shortage
this quarter. As previously disclosed, the Company does not intend to distribute
flu vaccine after the 2009 flu season. Contract manufacturing revenue decreased
by $0.6 million or 25%, mainly due to decreased order volumes on ophthalmic
contract products. 

Consolidated gross profit was $2.7 million or 13.9% of revenue for the third
quarter of 2009 as compared to a gross profit of $9.9 million or 31.1% of
revenue in the same period a year ago. The decrease in third quarter 2009 gross
profit compared to the prior year period is primarily due to lower vaccine sales
and an increase in Td vaccine unit cost. Also contributing to the decrease were
the lower hospital drug and injectable and ophthalmic sales and a corresponding
negative impact on manufacturing capacity utilization. 

During the third quarter of 2009, the Company recognized equity earnings
totaling $0.5 million from its investment in the Akorn-Strides, LLC joint
venture and marketing fee revenue of $0.3 million for its commission on sales of
joint venture products. The joint venture recognized net sales of approximately
$3.8 million during third quarter 2009. Joint venture sales increased $1.9
million over the second quarter 2009 as a result of a full quarter of sales of
injectable Vancomycin, which launched in June 2009. 

The Company`s net loss was approximately $5.1 million in the third quarter 2009
compared to a net profit of $2.4 million in the third quarter 2008. This
reflects the revenue and gross profit decreases and a $1.1 million charge for
the change in the fair value of warrants issued in conjunction with the
Company`s renegotiated revolving line of credit and subordinated debt, offset by
a $1.0 million decrease in selling, general and administrative expense compared
to the prior year period resulting from targeted cost reductions. Adjusted
EBITDA (a non-GAAP financial measure defined below) for third quarter 2009 was a
negative $1.6 million compared with a positive $4.4 million Adjusted EBITDA in
the prior year period. 

Third quarter cash flow from operating activities was a use of $0.7 million. The
revolving line of credit ended the quarter with a balance of $7.5 million
compared to $5.5 million on June 30, 2009, while the cash balance ended at $2.0
million on September 30, 2009 compared with $1.0 million on June 30, 2009. 

Akorn also announces the launch of the generic version of Acular (Ketorolac
Tromethamine Ophthalmic), a drug with estimated brand sales of $119 million in
2008 according to IMS data. In addition, the company launched Hydralazine
Hydrochloride, an existing generic, with estimated sales of $23 million in 2008
according to IMS data. 

Raj Rai, Interim Chief Executive Officer said, "We are very pleased with the
progress we have made this quarter. While we are on track to achieve the
operational objectives we initiated in the second quarter, we are transitioning
the company to generate higher margins from the sale of our core ophthalmic and
hospital products and positive cash flow in the fourth quarter." 

Rai further stated, "We are pleased to announce the launch of two new generic
products, Ketorolac Tromethamine and Hydralazine HCL. These products, in
addition to the products launched in the third quarter, will serve as building
blocks to the future growth of the company." 

About Akorn, Inc. 

Akorn, Inc. manufactures and markets sterile specialty pharmaceuticals. Akorn
has manufacturing facilities located in Decatur, Illinois and Somerset, New
Jersey and markets and distributes an extensive line of hospital and ophthalmic
pharmaceuticals. Additional information is available at the Company`s website at
www.akorn.com. 

This press release includes statements that may constitute "forward-looking
statements", including with regard to the company's future operations and its
earnings expectations. These statements are made pursuant to the safe harbor
provisions of the Private Securities Litigation Reform Act of 1995. Because such
statements inherently involve risks and uncertainties, actual future results may
differ materially from those expressed or implied by such forward-looking
statements. You can identify these statements by the fact that they do not
relate strictly to historical or current facts. They use words such as
"anticipate," "estimate," "expect," "project," "intend," "plan," "believe," and
other words and terms of similar meaning in connection with a discussion of
future operating or financial performance. Factors that could cause or
contribute to such differences include, but are not limited to: statements
relating to future steps we may take, prospective products, future performance
or results of current and anticipated products, sales efforts, expenses, the
outcome of contingencies such as legal proceedings, and financial results. These
cautionary statements should be considered in connection with any subsequent
written or oral forward-looking statements that may be made by the company or by
persons acting on its behalf and in conjunction with its periodic SEC filings.
You are advised, however, to consult any further disclosures we make on related
subjects in our reports filed with the SEC. In particular, you should read the
discussion in the section entitled "Cautionary Statement Regarding
Forward-Looking Statements" in our most recent Annual Report on Form 10-K, as it
may be updated in subsequent reports filed with the SEC. That discussion covers
certain risks, uncertainties and possibly inaccurate assumptions that could
cause our actual results to differ materially from expected and historical
results. Other factors besides those listed there could also adversely affect
our results. 

Non-GAAP Financial Measures 

In addition to reporting all financial information required in accordance with
generally accepted accounting principles (GAAP), Akorn is also reporting
Adjusted EBITDA, which is a non-GAAP financial measure. Since Adjusted EBITDA is
not a GAAP financial measure, it should not be used in isolation or as a
substitute for consolidated statements of operations and cash flow data prepared
in accordance with GAAP. In addition, Akorn`s definition of Adjusted EBITDA may
not be comparable to similarly titled non-GAAP financial measures reported by
other companies. For a full reconciliation of Adjusted EBITDA to net income
(loss), please see the attachments to this earnings release. 

Adjusted EBITDA, as defined by the Company, is calculated as follows: 

Net income/(loss), plus:

* Interest income/(expense), net 
* Provision for income taxes 
* Depreciation and amortization 
* Non-cash expenses, such as share-based compensation expense and changes in the
fair value of warrants 
* Non-recurring operating expenses, such as supply agreement termination
expenses

The Company believes that Adjusted EBITDA is a meaningful indicator, to both
Company management and investors, of the past and expected ongoing operating
performance of the Company. EBITDA is a commonly used and widely accepted
measure of financial performance. Adjusted EBITDA is deemed by the Company to be
a useful performance indicator because it includes an add back of non-cash and
non-recurring operating expenses which have little to no bearing on cash flows
and may be subject to uncontrollable factors not reflective of the Company`s
true operational performance (i.e. fair value adjustments to the carrying value
of stock warrants liability). 

While the Company uses Adjusted EBITDA in managing and analyzing its business
and financial condition and believes it to be useful to investors in their
evaluating the Company`s performance, Adjusted EBITDA has certain shortcomings.
Specifically, Adjusted EBITDA does not take into account the impact of capital
expenditures on the liquidity or GAAP financial performance of the company and
likewise omits share-based compensation expenses, which may vary over time and
may represent a material portion of overall compensation expense. Accordingly,
the Company`s management utilizes comparable GAAP financial measures to evaluate
the business in conjunction with Adjusted EBITDA and encourages investors to do
likewise.

                                                                                                                                                                                                                                                     
 AKORN, INC.                                                                                                                                                                                                                                                 
 CONDENSED CONSOLIDATED BALANCE SHEETS                                                                                                                                                                                                                       
 IN THOUSANDS, EXCEPT SHARE DATA                                                                                                                                                                                                                             
                                                                                                                                                                                                                                                     
                                                                                                                                                                                                       September 30,            December 31,         
                                                                                                                                                                                                       2009                     2008                 
                                                                                                                                                                                                       (Unaudited)                                   
 ASSETS                                                                                                                                                                                                                                               
 CURRENT ASSETS                                                                                                                                                                                                                                         
              Cash and cash equivalents                                                                                                                                                                  $        2,018          $        1,063      
              Trade accounts receivable (less allowance for doubtful accounts of $2 and $22, respectively)                                                                                                        11,360                  6,529      
              Other receivable                                                                                                                                                                                    -                       1,221      
              Inventories                                                                                                                                                                                         17,409                  30,163     
              Prepaid expenses and other current assets                                                                                                                                                           485                     1,770      
                                                                           TOTAL CURRENT ASSETS                                                                                                                  31,272                  40,746     
 PROPERTY, PLANT AND EQUIPMENT, NET                                                                                                                                                                                32,169                  34,223     
 OTHER LONG-TERM ASSETS                                                                                                                                                                                                                                 
              Intangibles, net                                                                                                                                                                                    5,033                   6,017      
              Deferred financing costs                                                                                                                                                                            4,060                   272        
              Other                                                                                                                                                                                               1,892                   1,071      
                                                                           TOTAL OTHER LONG-TERM ASSETS                                                                                                          10,985                  7,360      
                                                                           TOTAL ASSETS                                                                                                                 $        74,426         $        82,329     
                                                                                                                                                                                                                                                     
 LIABILITIES AND SHAREHOLDERS' EQUITY                                                                                                                                                                                                                   
 CURRENT LIABILITIES                                                                                                                                                                                                                                    
              Trade accounts payable                                                                                                                                                                     $        4,458          $        8,795      
              Accrued compensation                                                                                                                                                                                1,469                   1,070      
              Accrued expenses and other liabilities                                                                                                                                                              3,856                   2,906      
              Short-term subordinated debt - related party                                                                                                                                                        -                       5,332      
              Revolving line of credit - related party                                                                                                                                                            7,509                   -          
              Warrants liability - related party                                                                                                                                                                  6,654                   -          
              Supply agreement termination costs                                                                                                                                                                  1,500                   -          
                                                                           TOTAL CURRENT LIABILITIES                                                                                                             25,446                  18,103     
 LONG-TERM LIABILITIES                                                                                                                                                                                                                                  
              Lease incentive obligations                                                                                                                                                                         1,350                   1,484      
              Product warranty liability                                                                                                                                                                          1,299                   1,299      
              Subordinated note - related party                                                                                                                                                                   5,853                   -          
                                                                           TOTAL LONG-TERM LIABILITIES                                                                                                           8,502                   2,783      
                                                                                                                                        TOTAL LIABILITIES                                                       33,948                  20,886     
 SHAREHOLDERS' EQUITY                                                                                                                                                                                                                                   
              Common stock, no par value -- 150,000,000 shares authorized, 90,340,678 and 90,072,662 shares issued and outstanding at September 30, 2009 and December 31, 2008, respectively                      173,304                 170,617    
              Warrants to acquire common stock                                                                                                                                                                    1,821                   2,731      
              Accumulated deficit                                                                                                                                                                                 (134,647)               (111,905)  
                                                                           TOTAL SHAREHOLDERS' EQUITY                                                                                                            40,478                  61,443     
 TOTAL LIABILITIES AND SHAREHOLDERS' EQUITY                                                                                                                                                               $        74,426         $        82,329     
                                                                                                                                                                                                                                                      


                                                                                                                                                                             
 AKORN, INC.                                                                                                                                                                 
 CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS                                                                                                                             
 IN THOUSANDS, EXCEPT PER SHARE DATA                                                                                                                                         
 (UNAUDITED)                                                                                                                                                                 
                                                                                                                                                                   
                                                                                                                                                                   
                                                                    THREE MONTHS ENDED                                 NINE MONTHS ENDED                               
                                                                    SEPTEMBER 30,                                      SEPTEMBER 30,                                   
                                                                    2009                     2008                    2009                      2008                
                                                                                                                                                                   
 Revenues                                                            $    19,371            $    31,874           $    57,711             $    67,562       
 Cost of revenue                                                          16,686                 21,968                47,997                  49,082       
                               GROSS PROFIT                              2,685                  9,906                 9,714                   18,480       
                                                                                                                                                                   
 Selling, general and administrative expenses                             5,187                  6,199                 18,016                  18,370       
 Supply agreement termination expenses                                    -                      -                     5,929                   -            
 Amortization of intangibles                                              320                    339                   1,234                   1,016        
 Research and development expenses                                        1,013                  1,143                 3,681                   4,744        
                               TOTAL OPERATING EXPENSES                  6,520                  7,681                 28,860                  24,130       
                                                                                                                                                                   
                               OPERATING INCOME (LOSS)                   (3,835  )              2,225                 (19,146  )              (5,650  )    
                                                                                                                                                                   
 Write-off and amortization of deferred financing costs                   (187    )              -                     (1,739   )              -            
 Interest expense, net                                                    (441    )              (295    )             (1,095   )              (579    )    
 Equity in earnings of unconsolidated joint venture                       484                    447                   672                     447          
 Change in fair value of warrants liability                               (1,122  )              -                     (1,432   )              -            
 Other income (expense)                                                   -                      24                    -                       (177    )    
                               INCOME (LOSS) BEFORE INCOME TAXES         (5,101  )              2,401                 (22,740  )              (5,959  )    
 Income tax provision                                                     -                      -                     2                       3            
                               NET INCOME (LOSS)                    $    (5,101  )         $    2,401            $    (22,742  )         $    (5,962  )    
                                                                                                                                                                   
 NET INCOME (LOSS) PER SHARE:                                                                                                                                       
                               BASIC                                $    (0.06   )         $    0.03             $    (0.25    )         $    (0.07   )    
                               DILUTED                              $    (0.06   )         $    0.03             $    (0.25    )         $    (0.07   )    
                                                                                                                                                                   
 SHARES USED IN COMPUTING NET INCOME (LOSS) PER SHARE:                                                                                                              
                               BASIC                                     90,303                 89,250                90,209                  89,169       
                               DILUTED                                   90,303                 90,065                90,209                  89,169       
                                                                                                                                                           


                                                                                                                                                                                                                       
 AKORN, INC.                                                                                                                                                                                                           
 CONDENSED CONSOLIDATED STATEMENT OF CASH FLOWS                                                                                                                                                                        
 IN THOUSANDS (UNAUDITED)                                                                                                                                                                                              
                                                                                                                                                                                                            
                                                                                                                                                                                                            
                                                                                                            THREE MONTHS ENDED                                 NINE MONTHS ENDED                                
                                                                                                            SEPTEMBER 30,                                      SEPTEMBER 30,                                    
                                                                                                            2009                     2008                    2009                      2008                 
 OPERATING ACTIVITIES                                                                                                                                                                                         
 Net income (loss)                                                                                            $    (5,101  )         $    2,401            $    (22,742  )         $    (5,962   )    
 Adjustments to reconcile net income (loss) to net cash used in operating activities:                                                                                                                         
                                Depreciation and amortization                                                     1,270                  1,126                 4,118                   3,348         
                                Write-off and amortization of deferred financing fees                             187                    -                     1,739                   -             
                                Non-cash stock compensation expense                                               432                    572                   1,675                   1,821         
                                Non-cash supply agreement termination expense                                     -                      -                     1,051                   -             
                                Non-cash change in fair value of warrants liability                               1,122                  -                     1,432                   -             
                                Gain on disposal of assets                                                        -                      (25     )             -                       (25      )    
                                Equity in earnings of unconsolidated joint venture                                (484    )              (447    )             (672     )              (447     )    
                                Changes in operating assets and liabilities:                                                                                                                                 
                                                               Trade accounts receivable                         (2,316  )              (5,631  )             (4,831   )              (11,620  )    
                                                               Inventories                                       7,198                  (3,058  )             12,754                  2,662         
                                                               Prepaid expenses and other current assets         654                    112                   1,228                   252           
                                                               Other long-term assets                            -                      -                     -                       1,246         
                                                               Supply agreement termination liabilities          (3,250  )              -                     1,500                   -             
                                                               Trade accounts payable                            (781    )              2,988                 (4,337   )              (6,651   )    
                                                               Accrued expenses and other liabilities            332                    719                   1,736                   1,081         
 NET CASH USED IN OPERATING ACTIVITIES                                                                             (737    )              (1,243  )             (5,349   )              (14,295  )    
                                                                                                                                                                                                            
 INVESTING ACTIVITIES                                                                                                                                                                                         
 Purchases of property, plant and equipment                                                                        (280    )              (1,322  )             (922     )              (2,742   )    
 Purchase of product licensing rights                                                                              -                      -                     (250     )              -             
 Proceeds from sale of fixed assets                                                                                -                      74                    -                       74            
 NET CASH USED IN INVESTING ACTIVITIES                                                                             (280    )              (1,248  )             (1,172   )              (2,668   )    
                                                                                                                                                                                                            
 FINANCING ACTIVITIES                                                                                                                                                                                         
 Repayment of long-term debt                                                                                       -                      -                     -                       (208     )    
 Restricted cash for revolving credit agreement                                                                    -                      -                     -                       (2,050   )    
 Loan origination fees - revolving line of credit & subordinated note                                              (43     )              -                     (1,356   )              -             
 Proceeds from (repayments of) line of credit                                                                      2,000                  (3,931  )             7,509                   5,727         
 Proceeds from warrants exercised                                                                                  -                      -                     -                       37            
 Proceeds from subordinated note                                                                                   -                      5,000                 -                       5,000         
 Proceeds under stock option and stock purchase plans                                                              59                     143                   1,323                   599           
 NET CASH PROVIDED BY FINANCING ACTIVITIES                                                                         2,016                  1,212                 7,476                   9,105         
                                                                                                                                                                                                            
 INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS                                                                  999                    (1,279  )             955                     (7,858   )    
 Cash and cash equivalents at beginning of period                                                                  1,019                  1,369                 1,063                   7,948         
 CASH AND CASH EQUIVALENTS AT END OF PERIOD                                                                   $    2,018             $    90               $    2,018              $    90            
                                                                                                                                                                                                      


                                                                                                                                                                                          
 AKORN, INC.                                                                                                                                                                              
 RECONCILIATION OF NET INCOME (LOSS) TO NON-GAAP ADJUSTED EBITDA                                                                                                                          
 IN THOUSANDS (UNAUDITED)                                                                                                                                                                 
                                                                                                                                                                                
                                                                                                                                                                                
                                                                                    THREE MONTHS ENDED                              NINE MONTHS ENDED                               
                                                                                    SEPTEMBER 30,                                   SEPTEMBER 30,                                   
                                                                                    2009                        2008              2009                      2008                
                                                                                                                                                                                
 NET INCOME (LOSS)                                                                   $     (5,101  )           $     2,401      $    (22,742  )         $    (5,962  )    
                                                                                                                                                                                
 ADJUSTMENTS TO ARRIVE AT EBITDA:                                                                                                                                                
                          Depreciation and amortization                                   1,270                     1,126           4,118                   3,348        
                          Interest expense, net                                           441                       295             1,095                   579          
                          Income tax provision                                            -                         -               2                       3            
 EBITDA                                                                              $     (3,390  )           $     3,822      $    (17,527  )         $    (2,032  )    
                                                                                                                                                                                
 NON-RECURRING & NON-CASH OPERATING EXPENSES:                                                                                                                                    
                          Non-cash stock compensation expense                             432                       572             1,675                   1,821        
                          Change in fair value of warrants liability                      1,122                     -               1,432                   -            
                          Write-off and amortization of deferred financing costs          187                       -               1,739                   -            
                          Supply agreement termination expense                            -                         -               5,929                   -            
 ADJUSTED EBITDA                                                                     $     (1,649  )           $     4,394      $    (6,752   )         $    (211    )    


Akorn, Inc.
Tim Dick, Chief Financial Officer
(847) 279-6100 



Copyright Business Wire 2009

 

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