-----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, O5gQwkhLLixRIJo3DN7k4hf+e7eOY7Z9caaJ8A5IBG6yhYk9ykHupW5uHCJ2wiFQ cVhD3l/Lp2idH52gn6/C2w== 0000950123-08-014253.txt : 20081104 0000950123-08-014253.hdr.sgml : 20081104 20081103182529 ACCESSION NUMBER: 0000950123-08-014253 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 4 CONFORMED PERIOD OF REPORT: 20081103 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20081104 DATE AS OF CHANGE: 20081103 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: 081158761 BUSINESS ADDRESS: STREET 1: 2500 MILLBROOK DRIVE CITY: BUFFALO GROVE STATE: IL ZIP: 60089 BUSINESS PHONE: 8472796100 MAIL ADDRESS: STREET 1: 2500 MILLBROOK DRIVE CITY: BUFFALO GROVE STATE: IL ZIP: 60089 8-K 1 c47425e8vk.htm FORM 8-K e8vk
Table of Contents

 
 
UNITED STATES
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 of 1934
Date of Report: November 3, 2008
(Date of earliest event reported)
Akorn, Inc.
(Exact name of registrant as specified in its charter)
         
Louisiana   001-32360   72-0717400
(State or other
jurisdiction of
incorporation)
  (Commission
File Number)
  (I.R.S. Employer
Identification No.)
1925 West Field Court, Suite 300
Lake Forest, IL 60045

(Address of principal executive offices, zip code)
(800) 932-5676
(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))
 
 

 


TABLE OF CONTENTS

Item 2.02 Results of Operations and Financial Condition.
Item 7.01 Regulation FD Disclosure.
Item 9.01 Financial Statements and Exhibits.
SIGNATURES
EX-99.1
EX-99.2
EX-99.3


Table of Contents

Item 2.02 Results of Operations and Financial Condition.
     On November 3, 2008, Akorn, Inc. (“Akorn”) issued a press release announcing certain results of Akorn’s financial review for the quarter ended September 30, 2008. A copy of the press release is attached hereto as Exhibit 99.1.
Item 7.01 Regulation FD Disclosure.
     On November 3, 2008, Arthur S. Przybyl, President and Chief Executive Officer of Akorn, and Jeffrey A. Whitnell, Chief Financial Officer of Akorn, held a conference call with investors. The scripts for this call for Mr. Przybyl and Mr. Whitnell are attached hereto as Exhibits 99.2 and 99.3, respectively.
     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 November 3, 2008.
 
   
99.2
  Script of Mr. Przybyl for November 3, 2008 conference call.
 
   
99.3
  Script of Mr. Whitnell for November 3, 2008 conference call.

 


Table of Contents

SIGNATURES
     Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
  Akorn, Inc.
 
 
  By:   /s/ Jeffrey A. Whitnell    
    Jeffrey A. Whitnell   
    Chief Financial Officer, Treasurer and Secretary   
 
Date: November 3, 2008

 

EX-99.1 2 c47425exv99w1.htm EX-99.1 exv99w1
Exhibit 99.1
At the Company:
Akorn, Inc.
Arthur S. Przybyl, President and CEO
Jeffrey A. Whitnell, CFO
(847) 279-6100
FOR IMMEDIATE RELEASE
Akorn Reports Record Third Quarter 2008 Revenues of $31.9 million;
Earnings per Share of $0.03
Lake Forest, IL, November 3, 2008 — Akorn, Inc. (NASDAQ: AKRX) a specialty pharmaceutical company, today reported financial results for the third quarter ended September 30, 2008.
Total revenue for the third quarter 2008 was $31.9 million, versus $15.8 million in the third quarter 2007, and represents an increase of approximately 102%. Sequentially, third quarter 2008 revenues increased by $10.6 million or 50% versus the second quarter 2008. Ophthalmic business segment revenues totaled $5.1 million, an increase of 2% versus the prior year period. Hospital Drugs and Injectables business segment revenues (excluding DTPA) totaled $6.2 million, an increase of 50% versus the prior year period. Large year-over-year revenue increases were realized in analgesic and antidote/poison control product sales. Vaccine business segment revenues totaled $17.9 million, an increase of 278% versus the prior year period, when the Company initially launched its vaccine business segment. Current quarter vaccine revenues include approximately $12.8 million for Tetanus Diphtheria and $5.1 million for Flu vaccine sales. Contract Pharmaceutical Manufacturing business segment revenues totaled $2.6 million, an increase of 78% versus the prior year period, and reflect revenue from three new contract pharmaceutical manufacturing customers.
Gross profit for the third quarter 2008 was $9.9 million as compared to $3.0 million in the third quarter 2007, an increase of 234%. Sequentially, third quarter 2008 gross profit increased by $5.1 million or 105% versus the second quarter 2008. The increase in third quarter 2008 gross profit is due to growth in all business segment revenues, with vaccines contributing approximately $5.3 million of third quarter 2008 gross profit. Gross margin for the third quarter 2008 was 31.1% versus 18.8% in the third quarter 2007.
Arthur S. Przybyl, President and Chief Executive Officer stated, “We are pleased with our third quarter results and expect additional near-term catalysts to continue this momentum. Recently, in the Ophthalmics business segment, we received an NDA approval for and launched our topical anesthetic, Akten™. We expect Akten™ to become a significant revenue contributor to the Ophthalmics business segment as we pursue our objective to establish Akten™ as the standard of care whenever a topical

1


 

anesthetic is required during an ophthalmic surgical procedure. In our Hospital Drugs and Injectables business segment, we continue to expect near term product approvals and continue to pursue a forward deployment order for DTPA. We believe these events will generate significant revenues for this business segment.
The results of our third quarter demonstrate the importance of vaccines to our business strategy. The incremental revenues and gross profit from vaccines are the current catalysts for generating net income and positive cash flow for us. As our vaccine business model continues to mature, we expect to generate continued market share gains for both our Td and Flu vaccine products. Our recently announced agreements in our Contract Pharmaceutical Manufacturing business segment will serve to further increase revenues. Of the six new agreements announced in 2008, we have launched two and expect to launch the other four over the next twelve months. Finally, our Akorn-Strides Joint Venture launched its first product this quarter and contributed to our profitability. We have several near term product launches for the JV and look forward to its continued success.”
Total operating expenses were $7.7 million for the third quarter 2008 versus $7.8 million in the third quarter 2007. Selling, general and administrative expenses totaled $6.2 million in the third quarter 2008, an increase of $0.9 million over the third quarter 2007. This increase is primarily due to the expansion of our Sales Team from 30 to 65 representatives, which was completed in the first quarter 2008. Research and development expenses were $1.1 million in the third quarter 2008 versus $2.1 million in the comparative prior year period, reflecting lower spending for new product development milestone fees.
Interest and other income and expense for the third quarter 2008 resulted in a charge of $271K versus interest income of $140K in the third quarter 2007, and reflect higher borrowing costs and increased debt, which were partially offset by a $25K gain on the sale of fixed assets.
Joint venture income of $447K was recognized in the third quarter 2008, and represents the Company’s equity earnings from its 50% position in the Akorn-Strides, LLC joint venture. The joint venture also contributed a marketing fee of approximately $81K in the third quarter 2008, which the Company recognized as contract pharmaceutical manufacturing business segment revenue.
The Company’s net income was approximately $2.4 million in the third quarter 2008, or $0.03 per fully diluted share as compared to a net loss of approximately $4.7 million in the third quarter 2007, or $0.05 per fully diluted share. This improvement reflects incremental gross profit primarily from vaccine sales and all other business segments, including the minority interest in the Akorn-Strides, LLC joint venture.

2


 

Company Highlights:
  Ophthalmics Business Segment:
    September 8, 2008: Akorn announced FDA approval of IC-Green™ for Injection, USP, the first lyophilized product approval at our Decatur, IL facility.
 
    October 8, 2008: Akorn announced FDA approval of Akten™ Ophthalmic Gel 3.5%.
 
    October 15, 2008: Akorn announced the launch of Akten™ Ophthalmic Gel 3.5%.
  Hospital Drugs and Injectables Business Segment:
    July 11, 2008: Akorn announced the first commercial product launch for the Akorn-Strides, LLC Joint Venture, Rifampin for Injection USP, 600 mg/vial.
 
    September 2, 2008: Akorn announced FDA approvals for Dexamethasone Sodium Phosphate Injection USP, 4 mg (base)/mL and Dexamethasone Sodium Phosphate Injection USP, 10 mg (base)/mL.
  Biologics and Vaccines Business Segment:
    July 1, 2008: The effective date of a contract award from the Centers for Disease Control and Prevention (CDC) for Tetanus Diphtheria Vaccines.
 
    August 19, 2008: Akorn launches Afluria® Flu Vaccine.

3


 

  Contract Pharmaceutical Manufacturing Business Segment:
    July 3, 2008: Akorn announced the signing of a five-year commercial manufacturing and supply agreement at our Decatur, IL facility with Bioniche Pharma for two injectable drug products. Both products have been launched.
 
    July 9, 2008: Akorn announced the signing of a ten-year exclusive manufacturing and supply agreement at our Decatur, IL facility for the contract manufacture of several injectable drug products.
 
    September 11, 2008: Akorn announced the signing of a ten-year exclusive manufacturing and supply agreement at our Decatur, IL facility for the contract manufacture of two new ophthalmic drug products. The anticipated launch for both products is mid-2009.
 
    October 13, 2008: Akorn announced the signing of a five-year commercial manufacturing and supply agreement at our Decatur, IL facility for one ophthalmic drug product. Revenues from this Agreement are expected to begin in early 2009.

4


 

AKORN, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
IN THOUSANDS
                 
    SEPTEMBER 30,     DECEMBER 31,  
    2008     2007  
    (UNAUDITED)     (AUDITED)  
ASSETS
               
CURRENT ASSETS
               
Cash and cash equivalents
  $ 90     $ 7,948  
Restricted Cash for revolving credit agreement
    3,300       1,250  
Trade accounts receivable (less allowance for doubtful accounts of $13 and $5, respectively)
    15,732       4,112  
Inventories
    28,433       31,095  
Prepaid expenses and other current assets
    1,027       1,317  
 
           
TOTAL CURRENT ASSETS
    48,582       45,722  
PROPERTY, PLANT AND EQUIPMENT, NET
    34,476       32,262  
OTHER LONG-TERM ASSETS
               
Intangibles, net
    6,355       7,721  
Other
    850       1,261  
 
           
TOTAL OTHER LONG-TERM ASSETS
    7,205       8,982  
 
           
TOTAL ASSETS
  $ 90,263     $ 86,966  
 
           
LIABILITIES AND SHAREHOLDERS’ EQUITY
               
CURRENT LIABILITIES
               
Revolving line of credit
  $ 10,248     $ 4,521  
Mortgage payable
          208  
Short term subordinated debt
    5,135        
Trade accounts payable
    7,419       14,070  
Accrued compensation
    1,275       895  
Accrued expenses and other liabilities
    2,137       1,306  
 
           
TOTAL CURRENT LIABILITIES
    26,214       21,000  
LONG-TERM LIABILITIES
               
Lease incentive obligation
    1,597        
Product warranty liability
    1,299       1,308  
 
           
TOTAL LONG-TERM LIABILITIES
    2,896       1,308  
 
           
TOTAL LIABILITIES
    29,110       22,308  
 
           
SHAREHOLDERS’ EQUITY
               
Common stock, no par value — 150,000,000 shares authorized; 89,264,506 and 88,900,588 shares issued and outstanding at September 30, 2008 and December 31, 2007, respectively
    168,350       165,829  
Warrants to acquire common stock
    2,731       2,795  
Accumulated deficit
    (109,928 )     (103,966 )
 
           
TOTAL SHAREHOLDERS’ EQUITY
    61,153       64,658  
 
           
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY
  $ 90,263     $ 86,966  
 
           


 

AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
IN THOUSANDS, EXCEPT PER SHARE DATA
(UNAUDITED)
                                 
    THREE MONTHS ENDED     NINE MONTHS ENDED  
    SEPTEMBER 30,     SEPTEMBER 30,  
    2008     2007     2008     2007  
Revenues
  $ 31,874     $ 15,814     $ 67,562     $ 39,187  
Cost of sales
    21,968       12,846       49,082       30,844  
 
                       
GROSS PROFIT
    9,906       2,968       18,480       8,343  
Selling, general and administrative expenses
    6,199       5,362       18,370       15,793  
Amortization of intangibles
    339       338       1,016       1,015  
Research and development expenses
    1,143       2,135       4,744       6,307  
 
                       
TOTAL OPERATING EXPENSES
    7,681       7,835       24,130       23,115  
 
                       
OPERATING INCOME (LOSS)
    2,225       (4,867 )     (5,650 )     (14,772 )
Interest (expense)/income — net
    (295 )     140       (579 )     568  
Equity in earnings of unconsolidated joint venture
    447             447        
Other income/(expense)
    24             (177 )     1  
 
                       
INCOME (LOSS) BEFORE INCOME TAXES
    2,401       (4,727 )     (5,959 )     (14,203 )
Income tax provision
                3       1  
 
                       
NET INCOME (LOSS)
  $ 2,401     $ (4,727 )   $ (5,962 )   $ (14,204 )
 
                       
NET INCOME (LOSS) PER SHARE:
                               
BASIC
  $ 0.03     $ (0.05 )   $ (0.07 )   $ (0.16 )
 
                       
DILUTED
  $ 0.03     $ (0.05 )   $ (0.07 )   $ (0.16 )
 
                       
SHARES USED IN COMPUTING NET INCOME (LOSS) PER SHARE:
                               
BASIC
    89,250       87,651       89,169       86,971  
 
                       
DILUTED
    90,065       87,651       89,169       86,971  
 
                       

6


 

AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
IN THOUSANDS
(UNAUDITED)
                 
    NINE MONTHS  
    ENDED SEPTEMBER 30  
    2008     2007  
OPERATING ACTIVITIES
               
Net loss
  $ (5,962 )   $ (14,204 )
Adjustments to reconcile net loss to net cash used in operating activities:
               
Depreciation and amortization
    3,348       3,273  
Non-cash stock compensation expense
    1,821       2,484  
Gain on disposal of assets
    (25 )      
Changes in operating assets and liabilities:
               
Trade accounts receivable
    (11,620 )     (864 )
Inventories
    2,662       (8,015 )
Prepaid expenses and other current assets
    (195 )     (275 )
Other long-term assets
    1,246        
Trade accounts payable
    (6,651 )     7,319  
Accrued expenses and other liabilities
    1,081       (2,599 )
 
           
NET CASH USED IN OPERATING ACTIVITIES
    (14,295 )     (12,881 )
INVESTING ACTIVITIES
               
Purchases of property, plant and equipment
    (2,742 )     (1,420 )
Purchase of intangible assets
          (50 )
Proceeds from sale of fixed assets
    74        
 
           
NET CASH USED IN INVESTING ACTIVITIES
    (2,668 )     (1,470 )
FINANCING ACTIVITIES
               
Repayment of long-term debt
    (208 )     (293 )
Restricted cash for revolving credit agreement
    (2,050 )      
Proceeds from line of credit
    5,727        
Proceeds from warrants exercised
    37       2,507  
Proceeds from subordinated note
    5,000        
Proceeds under stock option and stock purchase plans
    599       579  
 
           
NET CASH PROVIDED BY FINANCING ACTIVITIES
    9,105       2,793  
DECREASE IN CASH AND CASH EQUIVALENTS
    (7,858 )     (11,558 )
Cash and cash equivalents at beginning of period
    7,948       21,818  
 
           
CASH AND CASH EQUIVALENTS AT END OF PERIOD
  $ 90     $ 10,260  
 
           
SUPPLEMENTAL DISCLOSURES
               
Leasehold improvements funded by lessor
  $ 1,768     $  
Assets acquired through capital lease
  $ 85     $  
Amount paid for interest
  $ 534     $ 43  
Amount paid for income taxes
  $ 3     $ 3  

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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.
Materials in this press release may contain information that includes or is based upon forward-looking statements within the meaning of the Securities Litigation Reform Act of 1995. Forward-looking statements give our expectations or forecasts of future events. 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. In particular, these include 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.
Any or all of our forward-looking statements here or in other publications may turn out to be wrong. They can be affected by inaccurate assumptions or by known or unknown risks and uncertainties. Many such factors will be important in determining our actual future results. Consequently, no forward-looking statement can be guaranteed. Our actual results may vary materially, and there are not guarantees about the performance of our stock.
Any forward-looking statements represent our expectations or forecasts only as of the date they were made and should not be relied upon as representing our expectations or forecasts as of any subsequent date. We undertake no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise, even if our expectations or forecasts change. 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.

8

EX-99.2 3 c47425exv99w2.htm EX-99.2 exv99w2
Exhibit 99.2
Good afternoon, ladies and gentlemen, and welcome to Akorn’s conference call. My name is Art Przybyl and presenting our financial position today is Jeff Whitnell, our CFO. We will hold a brief Q & A period at the end of the presentation.
Our third quarter operating results were excellent and demonstrate our execution to our business strategies and an evolving and improving business model. We realized large year over year increases in revenues, and gross profit, improved margins, and flat overall operating expenses. All segments of our business model contributed, ophthalmics, hospital drugs and injectables, vaccines, contract manufacturing and our newly launched Akorn-Strides JV. The result of this was profitability and positive EBITDA. Our third quarter EBITDA was approximately $3.9 million, which represented a year over year EBITDA turnaround of approximately $7.1 million. Our positive cash flow and availability to working capital remains sufficient to run our business for the foreseeable future. More importantly, recently announced and still expected near term significant business catalysts should help us to continue our momentum.
Total revenue for the third quarter was $31.9 million an increase of approximately 102% over the prior year period and a sequential 50% increase over the second quarter 2008. These are record quarterly revenues for us. Gross profit for the quarter was $9.9 million an increase of 234% over the prior year period. The increase in third quarter gross profit was due to revenue growth in all business segments, but primarily due to vaccine segment revenues which contributed $5.3 million of gross profit. Gross margins improved to 31.1% as compared to 18.8% in the prior year period. Sequentially, gross margins improved by 8 points from 22.7% to 31.1%.
Our ophthalmic business segment revenues increased by 2% to $5.1 million over the prior year period. Currently, we have 12 ophthalmic products under development, of these six are on file with the FDA and six are under development. Recently, we received our NDA approval for Akten and have subsequently announced that we have launched the product. As part of our Akten marketing launch, we have scheduled our formal product launch and clinical presentation to be kicked off at the American Academy

 


 

of Ophthalmology annual meeting in November in Atlanta, Georgia. To date we have 190 trials ongoing, representing $570,000 in potential annual sales and early results from 11 completed trials have all been very positive. We believe our total market opportunity for Akten is approximately $275 million as we pursue our objective to establish Akten “as the standard of care” whenever a topical anesthesia is required during an ophthalmic surgical procedure.
In our hospital drugs and injectables business segment, excluding DTPA, revenues increased by 50% to $6.2 million as compared to the prior year period. Strong year over year sales in analgesic and antidote/poison control products contributed to the increase. Additionally, revenue increases in year over year GPO contract compliancy have been a direct result of our investment in our hospital field sales team. Currently, we have 31 hospital drug and injectable products under development, of those, 9 are on file with the FDA and 22 are under development. We continue to expect near term product approvals, such as the one we announced earlier today for Adenosine, and significant product approvals such as our Vancomycin ANDA to further revenue increases for this business segment. We have several “Vancomycin type” product opportunities under development. At the same time, we continue to discuss the opportunity for a forward deployment order for DTPA and expect to provide a more detailed update in the near future.
The vaccine business segment currently generates the majority of our revenues and gross profit and has become an increasingly important part of our business model. Vaccine business segment revenues totaled $17.9 million an increase of 278% over the prior year period when we initially launched vaccines. Revenues include approximately $12.8 million for Tetanus Diptheria vaccine sales and $5.1 million for Flu vaccine sales. Our TD market share continues to increase, over 1500 hospitals are now buying our product and every major distributor has purchased the unit dose TD vaccine. Our inaugural Flu sales met our expectations and continued residual flu sales will be realized in the fourth quarter. Regarding vaccine development, we have a scheduled pre-IND meeting with CBER in the fourth quarter as we attempt to determine the bridging clinical trial requirements towards filing for a biologic license application for Hepatitis B. This is our first vaccine partnered with Serum Institute that we intend to

 


 

commercialize in the U.S. As our vaccine model continues to mature we expect to generate continued market share gains for both our TD and flu vaccine products, an example of the long term value associated with biologic license application vaccine products. Akorn remains committed to providing affordable vaccines for U.S. Healthcare and its consumers.
Contract Pharmaceutical Manufacturing business segment revenues totaled $2.6 million an increase of 78% as compared to the prior year period. Revenues from three new contract customer agreements, one signed in 2007 and two in 2008, contributed to the improved results. We expect our revenues to continue to increase since we still have four new customer agreements that had not yet launched at the end of the third quarter. One customer agreement has been launched in October 2008 and the other three are expected to launch in 2009. Of the six new agreements signed this year, two are for injectable products and four are for ophthalmic products.
Finally, our Akorn-Strides JV launched its first commercialized product and generated joint venture income of $447,000 representing Akorn’s equity earnings from its 50% position in the JV. The joint venture has now received 12 product approvals and has 6 products on file with the FDA and 11 products under development. Several joint venture products are scheduled to be launched in the near future.
I will now turn the conference call over to Jeff for an update on our financial position.
Thank you Jeff.

 

EX-99.3 4 c47425exv99w3.htm EX-99.3 exv99w3
Exhibit 99.3
Thank you, Art, and good afternoon ladies and gentlemen.
Total revenue for the third quarter 2008 was $31.9 million, versus $15.8 million in the third quarter 2007, an increase of $16.1 million or 101.6%. Third quarter 2008 revenues are the highest ever recorded by Akorn, with year-over-year increases in revenues realized in all four of our business segments.
Ophthalmics business segment revenues increased 2% over the prior year revenue total, which included sales of approximately $2.0 million from the re-introduction of IC-Green. Hospital Drugs and Injectables business segment revenues increased 36% over the prior year revenue total, as a result of strong antidote and analgesic product sales. Vaccine business segment revenues increased 278% over the prior year revenue total, when the Company initially launched Td Vaccine, and include the impact of Flu Vaccine product sales. Contract Pharmaceutical Manufacturing business segment revenues increased 72% over the prior year revenue total and reflect the impact of three new customers as well as a marketing fee that was earned on sales by the Akorn-Strides joint venture.
Gross profit for the third quarter 2008 was $9.9 million as compared to $3.0 million in the third quarter 2007. Year-over-year revenue increases in each of our four business segments also contributed to year-over-year gross profit increases in each business segment. However, the aggregate increase in third quarter 2008 gross profit of approximately $6.9 million is due primarily to product sales of unit dose Td Vaccines and antidotes, which contributed approximately $5.0 million and $1.1 million, respectively.
Gross margin for the third quarter 2008 was 31.1% versus 18.8% in the prior year period, and reflects the impact of high-margin antidote and unit dose Td Vaccine product sales.
Selling, general and administrative expenses totaled $6.2 million in the third quarter 2008, an increase of $0.9 million over the comparative prior year period. This increase is primarily due to the expansion of our Sales Team from 30 to 65 representatives, which was completed in the first quarter 2008.
Ex. 99.3

 


 

Research and development expenses were $1.1 million in the third quarter 2008 versus $2.1 million in the comparative prior year period, and reflect lower milestone payments for new product development activities.
Interest and other income and expense for the third quarter 2008 totaled $271K versus interest income of $140K in the comparative prior year period, and reflect higher borrowing costs and increased debt, which were partially offset by a $25K gain on the sale of fixed assets.
Also during the third quarter 2008, the Akorn-Strides joint venture initiated its first commercial product launch, Rifampin for Injection, a drug product used in the treatment of all forms of tuberculosis. The positive operating performance of the joint venture contributed approximately $447K of non-operating income to Akorn, representing our equity earnings from the 50% position we hold in the Akorn-Strides joint venture.
Net income for the third quarter 2008 was $2.4 million or $0.03 per fully diluted share, vs. a net loss of $4.7 million in the third quarter 2007 or $0.05 per fully diluted share. The September 30, 2008 fully diluted share count for the Company is approximately 90 million.
I would now like to draw your attention to the Balance Sheet. As of today, the Company has cash and restricted cash equal to $7.3 million, plus approximately $4.2 million of undrawn upon availability under our Credit Agreement. Trade receivables as of September 30, 2008 totaled $15.7 million, and reflect increased product sales in all four business segments. The financial strength and liquidity provided by enhanced operational cash flows will enable us to continue to reduce the outstanding balance on our Credit Agreement Revolver.
To date, we have used our Revolver primarily to fund our investment in Td Vaccines. As of September 30, 2008, our carrying value on the balance sheet for unit dose Td Vaccine was approximately $13.8 million, an increase over the second quarter 2008 of $2.9 million. During the third quarter 2008, we completed the exchange of our entire multi dose Td Vaccine inventory for unit dose preservative free Td Vaccine with our supplier, and are now selling unit dose preservative free Td Vaccine exclusively. In order to facilitate this inventory exchange, we negotiated a $5.0 million subordinated note that is due and payable in July 2009.
Ex. 99.3

 


 

Td Vaccine shipments continued to accelerate in the third quarter 2008, due to increased unit dose Td Vaccine sales to U.S. hospitals and Distributors. We believe that as our presence in the hospital market and the office-based physician market for Td Vaccine continues to increase, we will remain cash flow positive and have sufficient working capital to meet our business requirements.
The other addition to our balance sheet during the third quarter 2008 is a caption for capital leases of approximately $1.8 million, which represents the value of tenant improvements at our new Distribution Facility in Gurnee, IL and our new Corporate Headquarters in Lake Forest, IL.
Finally, I would like to briefly review the Statement of Cash Flows. During the third quarter 2008, we generated EBITDA of approximately $3.9 million.
Thank you for your time and attention. I will now turn the teleconference back to Art.
Ex. 99.3

 

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