-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, S3oXJ2GwonY/BJcIqbsP9j3mEdjULJgTPGEEprcW+Za1eMlqI5L3BaU46CNRC1wk xXIpGWSuQeJP7Gn4y5drjQ== 0000950123-09-033618.txt : 20090811 0000950123-09-033618.hdr.sgml : 20090811 20090811172510 ACCESSION NUMBER: 0000950123-09-033618 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20090811 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20090811 DATE AS OF CHANGE: 20090811 FILER: COMPANY DATA: COMPANY CONFORMED NAME: AKORN INC CENTRAL INDEX KEY: 0000003116 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 720717400 STATE OF INCORPORATION: LA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-32360 FILM NUMBER: 091004680 BUSINESS ADDRESS: STREET 1: 1925 W. FIELD COURT, SUITE 300 CITY: LAKE FOREST STATE: IL ZIP: 60045 BUSINESS PHONE: 8472796100 MAIL ADDRESS: STREET 1: 1925 W. FIELD COURT, SUITE 300 CITY: LAKE FOREST STATE: IL ZIP: 60045 8-K 1 c53005e8vk.htm FORM 8-K FORM 8-K
 
 
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
FORM 8-K
CURRENT REPORT
Pursuant to Section 13 or 15(d) of the Securities Exchange Act
Date of Report: August 11, 2009
(Date of Earliest Event Reported)
Akorn, Inc.
(Exact Name of Registrant as Specified in its Charter)
         
Louisiana
(State or other
Jurisdiction of
Incorporation)
  001-32360
(Commission
File Number)
  72-0717400
(I.R.S. Employer
Identification No.)
1925 W. Field Court, Suite 300
Lake Forest, Illinois 60045

(Address of principal executive offices)

(847) 279-6100
(Registrant’s telephone number, including area code)
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions (See General Instruction A.2. below):
o   Written communication pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o   Pre-commencement communication pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o   Pre-commencement communication pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240. 13e-4(c))
 
 

 


 

Item 2.02   RESULTS OF OPERATIONS AND FINANCIAL CONDITION.
     On August 11, 2009, Akorn, Inc. (“Akorn”) issued a press release announcing certain results of Akorn’s financial review for the quarter ended June 30, 2009. A copy of the press release is attached hereto as Exhibit 99.1 to this report on Form 8-K and is incorporated herein by reference.
Item 7.01   REGULATION FD DISCLOSURE.
     On August 11, 2009, Rajat Rai, Interim Chief Executive Officer of Akorn, and Timothy A. Dick, Chief Financial Officer of Akorn, held a conference call with investors. The transcript of this call is attached hereto as Exhibit 99.2.
     The information in each item of this report, including the exhibits hereto, shall not be deemed to be “filed” for purposes of Section 18 of the Securities Exchange Act of 1934 (the “Exchange Act”) or otherwise subject to the liabilities of that section, nor shall it be deemed to be incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing.
     We expressly disclaim any obligation to update these exhibits and caution that they are only accurate on the date they were presented. The inclusion of any data or statements in these exhibits does not signify that the information is considered material.
Item 9.01   FINANCIAL STATEMENTS AND EXHIBITS.
  (d)   Exhibits.
 
  99.1   Press release dated August 11, 2009.
 
  99.2   Transcript of August 11, 2009 conference call.

 


 

SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this Current Report on Form 8-K to be signed on its behalf by the undersigned hereunto duly authorized.
         
  Akorn, Inc.
 
 
  By:   /s/ Timothy A. Dick    
    Timothy A. Dick   
    Chief Financial Officer   
 
Date: August 11, 2009

 

EX-99.1 2 c53005exv99w1.htm EX-99.1 EX-99.1
Exhibit 99.1
At the Company:
Akorn, Inc.
Tim Dick, Chief Financial Officer
(847) 279-6150
FOR IMMEDIATE RELEASE
Akorn Reports Second Quarter 2009 Financial Results
LAKE FOREST, Ill — Akorn, Inc. (NASDAQ: AKRX) a specialty pharmaceutical company, today reported financial results for the second quarter ended June 30, 2009.
Total revenue for the second quarter 2009 was $16.3 million, versus $21.2 million in the second quarter 2008, representing a decrease of approximately 23%. The revenue decrease was across all segments with the exception of contract manufacturing. Td vaccine revenue decreased $2.2 million or 22% and ophthalmics and hospital drugs & injectables revenue decreased $2.8 million or 31% compared with the prior year period. The year-over-year decrease in ophthalmics is primarily due to a $1.1 million adjustment in the product returns reserve. The hospital drugs & injectables decrease is a result of lower hospital antidote sales compared with the prior year period. In particular, the 2008 recall of Becton Dickinson syringes used in our cyanide antidote kit has resulted in an additional $242,000 in product returns reserve in the second quarter 2009 as well as a temporary downturn in our cyanide antidote kit sales cycle which we expect to reverse in the second half of 2009.
Gross profit for the second quarter 2009 was $1.7 million compared to $4.8 million in the second quarter 2008, a decrease of 65%. The decrease in second quarter 2009 gross profit over the prior year period is primarily due to the $1.3 million increase in our product returns reserve, lower sales of our more profitable antidote products and a higher concentration of low margin contract manufacturing products. Gross margin for the second quarter 2009 was 10.2% versus 22.7% for the second quarter 2008.
During the second quarter 2009, the Company recognized equity earnings totaling $128,000 from its investment in the Akorn-Strides, LLC joint venture and marketing fee revenue of $140,000 for its commission on sales of joint venture products. The joint venture recognized net sales of approximately $1.9 million during second quarter 2009. Joint venture sales increased $1.0 million over first quarter 2009 as a result of our second quarter 2009 launch of two new injectable drugs: Vancomycin and Tobramycin.
The Company’s net loss was approximately $7.0 million in the second quarter 2009 compared to a net loss of $2.8 million in the second quarter 2008. This reflects the revenue and gross profit decreases discussed above as well as a $0.5 million increase in research and development, mainly due to additional product development fees. The second quarter 2009 net loss also includes $0.6 million in severance charges and legal fees related to the renegotiated MBL supply agreement.

 


 

Second quarter cash flow from operating activities was a use of $3.1 million. The revolving line of credit balance remained unchanged at $5.5 million compared to the quarter ended March 31, 2009, while the cash balance ended at $1.0 million on June 30, 2009 compared with $4.7 million on March 31, 2009. Strong first and second quarter Td vaccine sales and corresponding cash collections resulted in improvements to the balance sheet with a $3.6 million reduction in trade accounts receivable, a $5.1 million reduction in inventory and a decrease of $7.5 million in trade accounts payable over the quarter ended March 31, 2009.
The Company is finalizing amendments to the existing revolving line of credit with EJ Funds and subordinated debt with The John N. Kapoor Trust, the terms of which will be more fully described in the Company’s Form 10-Q, which will be filed by August 17th.
Raj Rai, Interim Chief Executive Officer stated, “We have continued to make progress in the second quarter on various fronts while we re-position the Company for growth. A summary of actions taken so far in order to address the operational challenges that the Company has faced include:
    Reduced the company workforce by approximately 7% and implemented additional cost reduction strategies throughout the organization to realize approximately $6 million in annualized cost savings;
 
    Negotiated additional funding from EJ Funds for growth initiatives;
 
    Re-aligned the sales force to focus on the ophthalmics and hospital drugs & injectables with incentives to grow high margin products;
 
    Implemented strategies and operational plans to optimize plant productivity and supply chain inventory levels;
 
    Re-launched Aktenâ;
 
    Strengthened the management team.
Rai further added, “These measures were required to stabilize the Company’s operations. While we continue to look for additional operational efficiencies and cost saving opportunities, we will shift our focus in the second half of 2009 towards increasing the pull-through demand from our hospital clients, increasing direct sales in Ophthalmology and launching three new products: Capastat, Ciprofloxacin and Apraclonidine, as well as implementing new contract manufacturing accounts. With the steps taken in the second quarter and the new business initiatives, we believe the Company can achieve positive cash flow by the end of 2009.”

 


 

Revenue and Gross Profit by Segment
in Thousands (Unaudited)
                         
    THREE MONTH ENDED        
    JUNE 30,        
    2009     2008     Difference  
REVENUE
                       
Ophthalmic
  $ 2,984     $ 4,288       ($1,304 )
Hospital Drugs & Injectables
    3,306       4,851       (1,545 )
Biologics & Vaccines
    7,831       10,002       (2,171 )
Contract Services
    2,179       2,088       91  
 
                 
Total Revenues
  $ 16,300     $ 21,229       ($4,929 )
 
                 
 
                       
GROSS PROFIT
                       
Ophthalmic
    ($458 )   $ 968       ($1,426 )
Hospital Drugs & Injectables
    226       1,328       (1,102 )
Biologics & Vaccines
    1,661       1,786       (125 )
Contract Services
    237       745       (508 )
 
                 
Total Gross Profit
  $ 1,666     $ 4,827       ($3,161 )
 
                 
 
                       
GROSS MARGIN
                       
Ophthalmic
    -15.3 %     22.6 %        
Hospital Drugs & Injectables
    6.8 %     27.4 %        
Biologics & Vaccines
    21.2 %     17.9 %        
Contract Services
    10.9 %     35.7 %        
 
                   
Total Gross Margin
    10.2 %     22.7 %        
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.

 


 

AKORN, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
IN THOUSANDS, EXCEPT SHARE DATA
                 
    JUNE 30,     DECEMBER 31,  
    2009     2008  
    (UNAUDITED)     (AUDITED)  
ASSETS
               
CURRENT ASSETS
               
Cash and cash equivalents
  $ 1,019     $ 1,063  
Trade accounts receivable (less allowance for doubtful accounts of $18 and $22, respectively)
    9,044       6,529  
Other receivable
          1,221  
Inventories
    24,607       30,163  
Prepaid expenses and other current assets
    986       1,770  
 
           
TOTAL CURRENT ASSETS
    35,656       40,746  
PROPERTY, PLANT AND EQUIPMENT, NET
    32,839       34,223  
OTHER LONG-TERM ASSETS
               
Intangibles, net
    5,353       6,017  
Deferred financing costs
    1,391        272  
Other
    1,561       1,071  
 
           
TOTAL OTHER LONG-TERM ASSETS
    8,305       7,360  
 
           
TOTAL ASSETS
  $ 76,800     $ 82,329  
 
           
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
CURRENT LIABILITIES
               
Trade accounts payable
  $ 5,239     $ 8,795  
Accrued compensation
    1,158       1,070  
Accrued expenses and other liabilities
    3,077       2,906  
Short term subordinated debt — related party
    5,742       5,332  
Revolving line of credit — related party
    5,509        
Warrants liability
    2,719        
Supply agreement termination costs
    4,750        
 
           
TOTAL CURRENT LIABILITIES
    28,194       18,103  
LONG-TERM LIABILITIES
               
Lease incentive obligation
    1,394       1,484  
Product warranty liability
    1,299       1,299  
Other long-term liabilities
    825        
 
           
TOTAL LONG-TERM LIABILITIES
    3,518       2,783  
TOTAL LIABILITIES
    31,712       20,886  
 
           
SHAREHOLDERS’ EQUITY
               
Common stock, no par value — 150,000,000 shares authorized; 90,244,618 and 90,072,662 shares issued and outstanding at June 30, 2009 and December 31, 2008, respectively
    171,903       170,617  
Warrants to acquire common stock
    2,731       2,731  
Accumulated deficit
    (129,546 )     (111,905 )
 
           
TOTAL SHAREHOLDERS’ EQUITY
    45,088       61,443  
 
           
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $ 76,800     $ 82,329  
 
           

 


 

AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
IN THOUSANDS, EXCEPT PER SHARE DATA
(UNAUDITED)
                                 
    THREE MONTHS ENDED     SIX MONTHS ENDED  
    JUNE 30,     JUNE 30,  
    2009     2008     2009     2008  
Revenues
  $ 16,300     $ 21,229     $ 38,340     $ 35,688  
Cost of sales
    14,634       16,402       31,311       27,114  
 
                       
GROSS PROFIT
    1,666       4,827       7,029       8,574  
Selling, general and administrative expenses
    5,833       5,914       12,829       12,171  
Supply agreement termination expenses
    99             5,929        
Amortization of intangibles
    338       338       914       677  
Research and development expenses
    1,690       1,225       2,668       3,601  
 
                       
TOTAL OPERATING EXPENSES
    7,960       7,477       22,340       16,449  
 
                       
OPERATING LOSS
    (6,294 )     (2,650 )     (15,311 )     (7,875 )
Write-off of deferred financing costs
    (98 )           (1,552 )      
Interest expense, net
    (376 )     (169 )     (654 )     (284 )
Equity in earnings of unconsolidated joint venture
     128              188        
Change in warrants liability value
    (310 )           (310 )      
Other expense
                      (201 )
 
                       
LOSS BEFORE INCOME TAXES
    (6,950 )     (2,819 )     (17,639 )     (8,360 )
Income tax provision
                2       3  
 
                       
NET LOSS
  $ (6,950 )   $ (2,819 )   $ (17,641 )   $ (8,363 )
 
                       
NET LOSS PER SHARE:
                               
BASIC
  $ (0.08 )   $ (0.03 )   $ (0.20 )   $ (0.09 )
 
                       
DILUTED
  $ (0.08 )   $ (0.03 )   $ (0.20 )   $ (0.09 )
 
                       
SHARES USED IN COMPUTING NET LOSS PER SHARE:
                               
BASIC
    90,218       89,204       90,161       89,129  
 
                       
DILUTED
    90,218       89,204       90,161       89,129  
 
                       

 


 

AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
IN THOUSANDS (UNAUDITED)
                 
    SIX MONTHS  
    ENDED JUNE 30  
    2009     2008  
OPERATING ACTIVITIES
               
Net loss
  $ (17,641 )   $ (8,363 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
    2,848       2,222  
Amortization of deferred financing fees
    1,552        
Non-cash stock compensation expense
    1,243       1,249  
Non-cash supply agreement termination expense
    1,051        
Non-cash change in warrants liability value
    310        
Equity in earnings of unconsolidated joint venture
    (188 )      
Changes in operating assets and liabilities:
               
Trade accounts receivable
    (2,515 )     (5,989 )
Inventories
    5,556       5,720  
Prepaid expenses and other current assets
    574       140  
Other long-term assets
          1,246  
Supply agreement termination liabilities
    4,750        
Trade accounts payable
    (3,556 )     (9,639 )
Other long-term liabilities
     825        
Accrued expenses and other liabilities
    579       362  
 
           
NET CASH USED IN OPERATING ACTIVITIES
    (4,612 )     (13,052 )
INVESTING ACTIVITIES
               
Purchases of property, plant and equipment
    (642 )     (1,420 )
Purchase of product licensing rights
    (250 )      
 
           
NET CASH USED IN INVESTING ACTIVITIES
    (892 )     (1,420 )
FINANCING ACTIVITIES
               
Repayment of long-term debt
          (208 )
Restricted cash for revolving credit agreement
          (2,050 )
Loan origination fees — new revolving line of credit
    (1,313 )      
Proceeds from line of credit
    5,509       9,658  
Proceeds from exercise of stock warrants
          37  
Proceeds under stock option and stock purchase plans
    1,264       456  
 
           
NET CASH PROVIDED BY FINANCING ACTIVITIES
    5,460       7,893  
 
           
DECREASE IN CASH AND CASH EQUIVALENTS
    (44 )     (6,579 )
Cash and cash equivalents at beginning of period
    1,063       7,948  
 
           
CASH AND CASH EQUIVALENTS AT END OF PERIOD
  $ 1,019     $ 1,369  
 
           
SUPPLEMENTAL DISCLOSURES
               
Amount paid for interest
  $ 227     $ 366  
Amount paid for income taxes
  $ 3     $ 3  

 

EX-99.2 3 c53005exv99w2.htm EX-99.2 EX-99.2
Exhibit 99.2
(COVER PAGE)
Final Transcript
Conference Call Transcript AKRX — Q2 2009 Akorn, Inc. Earnings Conference Call Event Date/Time: Aug 11, 2009 / 02:00PM GMT THOMSON REUTERS

 


 

Final Transcript
Aug 11, 2009 / 02:00PM GMT, AKRX — Q2 2009 Akorn, Inc. Earnings Conference Call
CORPORATE PARTICIPANTS
Raj Rai
Akorn, Inc. — Interim CEO
Tim Dick
Akorn, Inc. — CFO
CONFERENCE CALL PARTICIPANTS
Scott Hirsch
Credit Suisse — Analyst
Ajit Nedungadi
TA Associates — Analyst
PRESENTATION
 
Operator
Good day and welcome to the Akorn Inc. conference call. Today’s call is being recorded. By now you should have received a copy of the press release issued by the Company this morning. If you have not received it, please call [Julie Richardson] at 847-279-6156 and it will be faxed to you promptly.
Please be advised, in keeping with SEC Regulation FD guidelines this call may also be accessed by webcast through Akorn’s website at www.Akorn.com. Any remarks that Akorn may make about future expectations, plans, and prospects for Akorn constitute forward-looking statements for purposes of the Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by those forward-looking statements.
Such forward-looking statements involve important risks and uncertainties that could significantly affect anticipated results in the future and accordingly such results may differ from those expressed in any forward-looking statements made by us on our behalf. These risks and uncertainties and other important factors are discussed in Akorn’s annual report on Form 10-K for the year ended the December 31, 2008, which is on file with the SEC.
Akorn anticipates that subsequent events and developments may cause its estimates to change or it may elect to update these forward-looking statements at some point in the future. Akorn specifically disclaims any obligation to do so.
At this time for opening remarks and introductions I would like to turn the conference over to Interim CEO, Raj Rai.
 
Raj Rai - Akorn, Inc. — Interim CEO
Thank you. Good morning, everyone, and thank you for joining our second-quarter 2009 conference call and our first call for the new management team. Also joining me on the call are Tim Dick, our Chief Financial Officer; [Jill Bonacoursey], our legal counsel; and [Shawn Brijensen], our Vice President of New Business Development.
I will discuss the key highlights for the quarter and Tim will discuss our results in detail later in the call. The second-quarter results reflect the ongoing challenges the Company has faced and the subsequent turnaround efforts whereby the focus of the Company was to stabilize cash flow and rationalize costs.
The Company had cash flow challenges in the first quarter with limited borrowing capabilities that resulted in the Company failing to meet some financial obligations. Since that time we have made significant progress in resolving the cash flow issues in addition to navigating the business through a tough economic environment and a highly competitive generic pharmaceutical industry. Let me walk you through the steps we undertook in bringing the Company to stability.

2


 

Final Transcript
Aug 11, 2009 / 02:00PM GMT, AKRX — Q2 2009 Akorn, Inc. Earnings Conference Call
First and foremost, we renegotiated our vaccine manufacturer partner to convert our exclusive distribution relationship to a nonexclusive agreement. The original agreement had approximately $58 million in purchase commitments for the remaining duration of the contract, which was successfully negotiated out for an early contract termination fee of $4.75 million. We also agreed to make our past due payments of $5.75 million.
In the second quarter we paid $4.5 million against the combined liability of $10.5 million. We have agreed to pay $4.5 million in the third quarter and the remainder of $1.5 million will be paid in June of 2010. We currently remain an authorized distributor of the TD vaccine and are actively selling the product.
Second, EJ Funds, an affiliate of Dr. John Kapoor, who is the chairman of Akorn, purchased a line of credit from GE Capital which was frozen at $5.65 million. I am pleased to report that the Company was able to manage through the available (inaudible) while making payments of its past due obligations for the first quarter. I am also pleased to announce that we have reached an agreement with EJ Funds to increase the availability to $10 million predominantly to fund future growth.
Third, we initiated a company-wide analysis on expenses which resulted in an annualized savings of approximately $6 million thus far. We expect to realize a full impact starting the fourth quarter of this year with the majority being realized in the third quarter. The cost reductions include a reduction of approximately 7% of the workforce in addition to various reduction of other expenditures at the corporate level and the plants.
We have other initiatives in place that would further reduce our spending to improve efficiencies in manufacturing. We will continue to provide an update on that in the next quarterly conference call.
Fourth, after careful consideration we have realigned our salesforce based on two key customer targets — physicians and hospitals. Our inside salesforce compliments the field sales efforts by making customer calls in territories not covered by the field salesforce. We expect that this realignment coupled with new incentive plans that are in place that compensates the salesforce for high revenues and higher margin products and the launch of new products will positively impact future sales growth.
In addition, we initiated the relaunch of Akten. As you may know, we got the approval of this product last year and launched the product in the fourth quarter of 2008. The launch was not as effective as planned. The Company at that time miscalculated the market size and the sales channel. In the second quarter we took the following corrective actions to relaunch the product.
First, we addressed the pricing to various customer channels — physicians, group purchasing organizations, and distributors — to be competitive. Secondly, we launched a sampling program which is still continuing and is expected to be substantially complete by year end. Finally, we focused on optimizing the product manufacturing levels to match our demand forecast. This was done to reduce the supply chain inventories from historical levels.
We believe that this would reduce the product returns and lower our margins for the Company by the end of this year.
Let me spend some time on the plans we have for the remainder of this year. We feel that we have done a lot of work in reducing the cash burn in the Company and are now ready to focus on growth going into the second half of the year. As noted in our press release, we launched two injectable products in the second quarter through our joint venture subsidiary Akorn-Strides. We are also pleased with the launch and expect to build on the initial success that we have had thus far.
In addition we plan to launch three new products in the third quarter — namely Capastat, Ciprofloxacin, and Apraclonidine. As you may recall, we acquired Capastat from Eli Lilly in the second quarter. In addition, we expect to launch one or two new drugs in the fourth quarter.
We have received a number of new product approvals in 2009. Unfortunately, a number of these approvals received are after the patent expirations and as a result we have decided not to launch these products as the market conditions have changed and they are not conducive for a successful commercialization. We will evaluate the launch of more such products as the market conditions change and justifies the commercialization.
We currently have 16 NDA filings under review with FDA and expect to file at least five more NDAs before the end of this year. We are actively reviewing new drug development opportunities and plan to have about 40 to 50 new drugs in various stages of development by the end of 2009.

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Final Transcript
Aug 11, 2009 / 02:00PM GMT, AKRX — Q2 2009 Akorn, Inc. Earnings Conference Call
All such drugs will be developed internally or through our existing and/or new partners, with strong emphasis on getting approvals prior to patent expirations and in therapeutic areas with high barriers to entry.
I feel in a short period of time we have accomplished a lot and have position the Company for growth. We have a diligent management team and a hard-working bench support that has sense of urgency and poised to execute on strategies to make Akorn successful with emphasis on regulatory compliance, high quality, and patient safety.
I will now turn the presentation to Tim who will review the financial highlights for the quarter. Tim?
 
Tim Dick - Akorn, Inc. — CFO
Thank you, Raj. Good morning. Total revenue for the second quarter 2009 was $16.3 million versus $21.2 million in the second quarter 2008, representing a decrease of approximately 23%. The revenue decrease was across all segments with the exception of contract manufacturing. TD vaccine revenue decreased $2.2 million or 22%, and ophthalmic and hospital drugs and injectables revenue decreased $2.8 million or 31% compared with the comparative prior-year period.
The year-over-year decrease in ophthalmic is primarily due to a $1.1 million adjustment in the product return reserve, a significant portion of that related to Akten for the reasons Raj spoke to earlier. The hospital drug and injectables decreased as a result of lower hospital antidote sales compared with a comparative prior-year period. In particular the 2008 recall of Becton Dickinson syringes used in our cyanide antidote kit has resulted in an additional $242,000 in our product returns reserve in the second quarter 2009, as well as a temporary downturn in our cyanide antidote kit sales cycle which we expect to reverse in the second half of 2009.
Contract manufacturing revenue was $2.2 million in Q2 versus $2.1 million in the comparative prior-year period. We do anticipate lower Q3 contract manufacturing revenue with fewer orders from two of our higher volume OTC customers directly attributable to the slowdown in retail sales. The Q4 launch of a new contract manufacturing customer should see us return to historical revenue levels.
During the second quarter of 2009 the Company recognized equity earnings totaling $128,000 from its investment in the Akorn-Strides joint venture and marketing fee revenue of $140,000 for its commission on sales of joint venture products. The joint venture recognized net sales of approximately $1.9 million during second quarter 2009. Joint venture sales increased $1 million over the first quarter 2009 as a result of our second-quarter 2009 launch of two new injectable drugs — Vancomycin and Tobramycin.
Gross profit for the second quarter 2009 was $1.7 million compared to $4.8 million in the second quarter 2008, a decrease of 65%. Decrease in second quarter 2009 gross profit over the comparative prior-year period is primarily due to the $1.3 million increase in our product returns reserve, lower sales of our more profitable antidote products, and a higher concentration of lower-margin contract manufacturing products. Gross margin for the second quarter 2009 was 10.2% versus 22.7% for the second quarter 2008.
Selling and general administrative expenses totaled $5.8 million in the second quarter 2009 including $500,000 in severance expense. This is down from $5.9 million in the comparative prior year period and from $7 million in the first quarter of 2009, and reflects a partial quarter’s impact of the cost control efforts Raj discussed in his opening remarks.
Research and development expense was $1.7 million in the second quarter 2009 versus $1.2 million in the comparative prior-year period. The $500,000 increase in R&D is mainly due to additional product development milestone fees.
Moving to other income and expense, the net of other income and expense items was an expense of $660,000 in Q2 2009 versus $170,000 in expense in the comparative prior-year period for a change of approximately $500,000. This is a result of interest expense in the subordinated debt with John N. Kapoor Trust, which was executed in Q3 of 2008, as well as the amortization of loan origination fees on the revolving line of credit with EJ Funds, the expense of marketing to market warrants issued in conjunction with the EJ Funds revolving line of credit and letter of credit with MBL, all partially offset by the equity income in the Akorn-Strides joint venture referred to earlier.
The Company’s net loss was approximately $7 million in the second quarter 2009 or a loss of $0.08 per fully diluted share versus a net loss of $2.8 million in the second quarter 2008 or $0.03 per fully diluted share. The June 30, 2009, fully diluted share count for the Company is 90.2 million shares.

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Final Transcript
Aug 11, 2009 / 02:00PM GMT, AKRX — Q2 2009 Akorn, Inc. Earnings Conference Call
Moving on to the balance sheet. Second-quarter cash flow from operating activities was a use of $3.1 million. The revolving line of credit balance remained unchanged at $5.5 million compared to the quarter ended March 31, 2009, while the cash balance ended at $1 million on June 30, 2009, compared with $4.7 million on March 31, 2009. Strong first and second-quarter TD vaccine sales and corresponding cash collections resulted in improvements to the balance sheet with a $3.6 million reduction in a trade accounts receivable, a $5.1 million reduction in inventory, and a decrease of $7.5 million in trade accounts payable over the quarter ended March 31, 2009.
June 30, 2009, ending inventory was $24.6 million of which $9.7 million was TD vaccine, down 38% from our March 31, 2009, level.
Finally, the Company is finalizing amendments to the existing revolving line of credit with EJ Funds and subordinated debt with The John N. Kapoor Trust, the terms of which will be more fully described in the Company’s Form 10-K which will be filed by August 17. We anticipate an increase in our credit available in our revolving line of credit to $10 million to support our growth initiatives. The line of credit will continue to be covenant free. We also anticipate extending the term of the subordinated debt and reclassifying this debt from current to long-term liabilities.
Thanks you for your attention. We will now turn it back over to Raj.
 
Raj Rai - Akorn, Inc. — Interim CEO
Thanks, Tim. May I ask the operator to open the lines for questions please?
QUESTION AND ANSWER
 
Operator
(Operator Instructions) Scott Hirsch, Credit Suisse.
 
Scott Hirsch - Credit Suisse — Analyst
Good morning. Just I guess first off, what are the initial areas of growth investment you are looking to make? Is it in the vaccine area? Will it be in the ophthalmic or hospital injectable area? What are the key areas you are looking to put money towards now?
 
Raj Rai - Akorn, Inc. — Interim CEO
Good morning, Scott. This is Raj. Our focus in the investment is going to be in new product development in the areas of our core competency, which is ophthalmology and the hospital injectables.
 
Scott Hirsch - Credit Suisse — Analyst
Okay. Where do vaccines stand now from, I guess, a normalized run rate? I know that expectations have previously been set a little bit high. Is this quarter a good run rate going forward or are inventories in the channel quite full?
 
Raj Rai - Akorn, Inc. — Interim CEO
We will see peak and troughs to the sales as the (inaudible) product gets pulled out from the wholesale levels. But we expect that — I think our comfort zone is around 2 million doses of TD vaccines a year; that is what our run rate is.
 
Scott Hirsch - Credit Suisse — Analyst
Two million doses a year?

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Final Transcript
Aug 11, 2009 / 02:00PM GMT, AKRX — Q2 2009 Akorn, Inc. Earnings Conference Call
 
Raj Rai - Akorn, Inc. — Interim CEO
Yes.
 
Scott Hirsch - Credit Suisse — Analyst
And is that aside from the government contract or does that include the government contract?
 
Raj Rai - Akorn, Inc. — Interim CEO
That includes the government contract.
 
Scott Hirsch - Credit Suisse — Analyst
And then I know you have mentioned before that Vanco is sort of a different priority now given the number of generic players, but curious if your version of oral Vanco is sort of the equivalent of both the active and inactive ingredients.
 
Raj Rai - Akorn, Inc. — Interim CEO
That is a correct statement that we have followed the Q1 and Q2, but at this time — obviously we will know when the product gets approved and then we are still waiting that.
 
Scott Hirsch - Credit Suisse — Analyst
So are you still positioned to participate in the opportunity?
 
Raj Rai - Akorn, Inc. — Interim CEO
Yes.
 
Scott Hirsch - Credit Suisse — Analyst
And then just to kind of go over some of the things that I think Tim said. So the $6 million in cost savings has started but it does not reflect in this quarter and will only partially reflect next quarter?
 
Tim Dick - Akorn, Inc. — CFO
No, no, no. It’s partially reflected in Q2.
 
Scott Hirsch - Credit Suisse — Analyst
Partially reflected in Q2?
 
Tim Dick - Akorn, Inc. — CFO
Right.

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Final Transcript
Aug 11, 2009 / 02:00PM GMT, AKRX — Q2 2009 Akorn, Inc. Earnings Conference Call
 
Raj Rai - Akorn, Inc. — Interim CEO
The majority we will see in the third quarter and then we will see the full impact of it in the fourth quarter.
 
Scott Hirsch - Credit Suisse — Analyst
Okay. Then outside the $1.3 million reserve, gross margin was more in the 18% range. What is the right run rate going forward on gross margin given where capacities are in the plant?
 
Tim Dick - Akorn, Inc. — CFO
I think we see — when you look at ophthalmic in particular, obviously, the returns and returns related to Akten were a significant drive drag on the margins in Q2. We believe we are adequately reserved on that going forward so we would expect to see our ophthalmic margins returned to kind of their historical run rate with upside as we reduce our product return expense on a go-forward basis.
Hospital drugs, I would say the same thing. We have a down cycle in antidote sales. We have some special cause around cyanide kit in particular, but other antidotes were down as well. Those tend to — those can be somewhat lumpy sales because those products aren’t intended to be used except on an emergency basis so as whole lots expire you get reorders from the market. So, again, we expect in Q3, Q4 for those to return to their historical run rates and that is going to pull up the hospital drug and injectable margins.
Then from a contract manufacturing standpoint, we alluded to a new contract coming online in Q4. That is really going to replace a downturn that we also spoke to in Q3 which is on very low margin products. It’s actually coming out in Q3 so we will see it hit on the top line. It should actually benefit our margins in Q3, but then we will see the top line on contract manufacturing step back up in Q4 at a much healthier margin.
 
Scott Hirsch - Credit Suisse — Analyst
And how is Akten doing just qualitatively out there? Is it being accepted by docs or —?
 
Raj Rai - Akorn, Inc. — Interim CEO
Yes. Scott, as I have mentioned, we have gone through a complete relaunch process and we took multiple steps. The first step was to address sampling with the retinal specialists, the second step was to price it appropriately, and thirdly, in the third quarter we will be focusing on marketing heavily to the cataract surgery centers. And so I think coupled with the emphasis and the focus and the realignment of our salesforce we will continue to see an improvement in the sales.
I will just give you a perspective that in the second quarter we saw a 40% increase in the number of units that were sold for the first quarter as a result of our emphasis on Akten. So it’s going to be —
 
Scott Hirsch - Credit Suisse — Analyst
And then just lastly, I think in the press release you guys indicated that you expect the fourth quarter to be near or profitable or in that trajectory. Is there a sense that third quarter you have probably gotten through the restructuring and can potentially have sort of a breakeven run rate, and then fourth quarter starts to grow off of that with a new contract manufacturing revenue and the like?
 
Raj Rai - Akorn, Inc. — Interim CEO
Well, I think as we said in the press release we will see the impact of our actual run rate in sales and margins that will be realized in the fourth quarter. The third quarter is still — we have done pretty much most of the clean up that needed to be done in the second quarter. Now the focus is launching new products in the third quarter so that is going to definitely help us.
Look, the Company had a lot of problems. I think we did a lot in the second quarter, but the healing will take a little bit more time but we think we will recover in the fourth quarter.

7


 

Final Transcript
Aug 11, 2009 / 02:00PM GMT, AKRX — Q2 2009 Akorn, Inc. Earnings Conference Call
 
Scott Hirsch - Credit Suisse — Analyst
All right. Just real quickly, what is the pipeline project at you are most excited about?
 
Raj Rai - Akorn, Inc. — Interim CEO
What we are looking at is really our core competency and the competency of some of our partners. We are looking at the ophthalmic, we are looking at manufacturing of narcotics and scheduled drugs that we have a competency in, and then there are certain injectables and we are looking at injectables that are we are board specialized. We are building a nice franchise around antidotes, so we are going to loop in that area. Then certainly sort of build upon the antibiotics and antivirals that we have worked on in the past.
 
Scott Hirsch - Credit Suisse — Analyst
Okay, great. Thank you.
 
Operator
(Operator Instructions) Ajit Nedungadi, TA Associates.
 
Ajit Nedungadi - TA Associates — Analyst
Thank you. My question is around the JV opportunity in the Vancomycin space. Could you comment a little bit as to how that product is coming along and your view on sort of how big that opportunity could be for the business?
 
Raj Rai - Akorn, Inc. — Interim CEO
Sure. Ajit, we launched Vancomycin at the end of the second quarter and we feel quite pleased with the launch and things have gone as we had planned. There is enough demand for Vancomycin in the US and we will continue to move forward with increasing the sales of that product.
We do expect — we do have some capacity issues which our joint venture partner is working on, and we expect to see an increased capacity by the end of this year from Strides.
 
Ajit Nedungadi - TA Associates — Analyst
Have you given any indication, are you willing to give any indication of how big you see that opportunity as being in revenues to the JV?
 
Raj Rai - Akorn, Inc. — Interim CEO
No, we don’t comment on product-specific revenues, but obviously this product will become a significant portion of our revenues going forward.
 
Ajit Nedungadi - TA Associates — Analyst
Okay, thank you.
 
Operator
With no further questions, I will turn the call back over to Raj Rai for further comments and closing remarks.

8


 

Final Transcript
Aug 11, 2009 / 02:00PM GMT, AKRX — Q2 2009 Akorn, Inc. Earnings Conference Call
 
Raj Rai - Akorn, Inc. — Interim CEO
Thank you, everyone, for joining our call. I know this is again — was a tough quarter for the Company, but we have taken steps and measures to fix some of the issues. We would like to get back to you at the next conference call to give you more updates and we look forward to speaking to you again soon. Thank you.
 
Operator
This does conclude today’s Akorn Inc. conference call. We thank you for your participation.

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-----END PRIVACY-ENHANCED MESSAGE-----