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Akorn Reports First Quarter 2008 Financial Results

Monday, May 12, 2008

BUFFALO GROVE, Ill.--(BUSINESS WIRE)--Akorn, Inc. (NASDAQ: AKRX) a specialty pharmaceutical company, today reported financial results for the first quarter ended March 31, 2008.

Total revenue for the first quarter 2008 was $14.5 million, versus $11.7 million in the first quarter 2007, and represents an increase of approximately 24%. During the first quarter 2008, Ophthalmic business segment revenues totaled $6.0 million, an increase of 41% versus the prior year period. Hospital Drugs and Injectables business segment revenues (excluding DTPA) totaled $5.0 million, an increase of 21% versus the prior year period. The Company recorded DTPA product revenues of approximately $1.3 million in the prior year first quarter versus negligible DTPA product revenues in the first quarter 2008. The Company also recorded Vaccine revenues of approximately $1.8 million in the first quarter 2008. These revenues reflect the launch of our unit dose preservative free Tetanus Diphtheria (Td) vaccine to the hospital market. We realized lower multiple dose Td vaccine sales in the first quarter 2008 than anticipated, but expect shipments to accelerate in the second quarter 2008, as Distributors exhaust their inventories. The Contract Pharmaceutical Manufacturing business segment recorded revenues of approximately $1.6 million in the first quarter 2008.

Gross profit for the first quarter 2008 was $3.7 million as compared to $2.5 million in the first quarter 2007, an increase of 48%. This resulted in an improvement in the Company’s gross margin from 21% to 26%. The increase in first quarter 2008 gross profit is due to a favorable product mix of Ophthalmic and Hospital Drugs and Injectables. Additionally, quarterly product shipments for IC-Green now reflect our historical run rate.

Arthur S. Przybyl, President and Chief Executive Officer stated, “The results of our first quarter are indicative of our improving business model. We are encouraged by our growth in all four of our business segments: Ophthalmics, Hospital Drugs and Injectables, Vaccines and Contract Pharma manufacturing. Whether apparent through reported revenue increases, market share gains, or manufacturing contracts, we are excited about our opportunities for the remainder of 2008. I will elaborate about the opportunities in detail for each of our four business segments in our earnings conference call this afternoon.”

Total operating expenses were $9.0 million for the first quarter 2008 versus $7.6 million in the first quarter 2007. Selling, general and administrative expenses totaled $6.3 million in the first quarter 2008, an increase of $1.0 million over the first quarter 2007. This increase is primarily due to the expansion of our Sales Team from 30 to 65 representatives. The expansion of our Sales Team was necessary for the launch of our two Vaccine products, Td and Flu, and our anticipated product approvals and subsequent launches of our Ophthalmic NDA, Akten™, and our ANDA for generic Vancomycin capsules. At this time, we have completed our planned Sales Team expansion. Research and development expenses were $2.4 million in the first quarter 2008 versus $2.0 million in the comparative prior year period, and increased due to the expensing of a previously capitalized and paid-for licensing fee and FDA filing fee.

The Company’s net operating loss was approximately $5.2 million in the first quarter 2008 as compared to $5.1 million in the first quarter 2007. This reflects the increase in product revenues of 24% and the increase in gross profit of 48%, offset by higher operating expenses including the one-time R&D write-off of $1.25 million, which increased our loss per share by $0.01. The net loss for the first quarter 2008 was $5.5 million or $0.06 per fully diluted share vs. the net loss of $4.8 million in the first quarter 2007 or $0.06 per fully diluted share.

Company Highlights:

  • Biologics and Vaccines Business Segment:
  •    -- February 21, 2008: Akorn announced the signing of a Specialty Distributor Agreement with CSL Biotherapies for Afluria(R) (Flu Vaccine).

  • Ophthalmics Business Segment:
  •    -- April 16, 2008: Akorn announced FDA approval of Ofloxacin Ophthalmic Solution USP, 0.3%.
       -- April 18, 2008: Akorn announced FDA approval of Diclofenac Sodium Ophthalmic Solution.

  • Hospital Drugs and Injectables Business Segment:
  •    -- January 30, 2008: Akorn announced FDA approval of Calcitriol Injection, 1 mcg/mL and 2 mcg/mL.
       -- March 19, 2008: Akorn announced FDA approval of Fosphenytoin Sodium Injection for Akorn-Strides, LLC.
       -- April 3, 2008: Akorn announced the signing of a supply agreement for a novel premix product with Fresenius Kabi.
       -- April 24, 2008: Akorn announced FDA approval of Ondansetron Injection for Akorn-Strides, LLC.

  • Contract Pharmaceutical Manufacturing Business Segment:
  •    -- February 14, 2008: Akorn announced the signing of a manufacturing and supply agreement at our Somerset, NJ facility for the contract manufacture of an ophthalmic solution. Initial shipments to the customer occurred in April 2008.
       -- March 24, 2008: Akorn announced the signing of a manufacturing and supply agreement at our Decatur, IL facility for the development and contract manufacture of three OTC eye care products.

    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.

    AKORN, INC.
    CONDENSED CONSOLIDATED BALANCE SHEETS
    IN THOUSANDS

       
    MARCH 31, DECEMBER 31,
      2008   2007
      (UNAUDITED)   (AUDITED)
    ASSETS
    CURRENT ASSETS
    Cash and cash equivalents $ 3,427 $ 7,948
    Restricted cash for revolving credit agreement 3,300 1,250
    Trade accounts receivable (less allowance for doubtful accounts
    of $3 and $5, respectively) 3,071 4,112
    Inventories 33,795 31,095
    Prepaid expenses and other current assets   1,294     1,317  
    TOTAL CURRENT ASSETS 44,887 45,722
    PROPERTY, PLANT AND EQUIPMENT, NET 31,752 32,262
    OTHER LONG-TERM ASSETS
    Intangibles, net 7,032 7,721
    Other   155     1,261  
    TOTAL OTHER LONG-TERM ASSETS   7,187     8,982  
    TOTAL ASSETS $ 83,826   $ 86,966  
    LIABILITIES AND SHAREHOLDERS EQUITY
    CURRENT LIABILITIES
    Revolving line of credit $ 11,264 $ 4,521
    Mortgage payable 105 208
    Trade accounts payable 8,344 14,070
    Accrued compensation 1,152 895
    Accrued expenses and other liabilities   1,342     1,306  
    TOTAL CURRENT LIABILITIES 22,207 21,000
    LONG-TERM LIABILITIES
    Product warranty   1,299     1,308  
    TOTAL LONG-TERM LIABILITIES   1,299     1,308  
    TOTAL LIABILITIES   23,506     22,308  
    SHAREHOLDERS EQUITY
    Common stock, no par value 150,000,000 shares authorized; 89,131,592 and
    88,900,588 shares issued and outstanding at March 31, 2008 and
    December 31, 2007, respectively 167,099 165,829
    Warrants to acquire common stock 2,731 2,795
    Accumulated deficit   (109,510 )   (103,966 )
    TOTAL SHAREHOLDERS EQUITY   60,320     64,658  
    TOTAL LIABILITIES AND SHAREHOLDERS EQUITY $ 83,826   $ 86,966  

    AKORN, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
    IN THOUSANDS, EXCEPT PER SHARE DATA
    (UNAUDITED)

     
    THREE MONTHS ENDED
    MARCH 31,
      2008     2007
    Revenues $ 14,459 $ 11,735
    Cost of sales   10,712     9,246  
    GROSS PROFIT 3,747 2,489
    Selling, general and administrative expenses 6,257 5,242
    Amortization of intangibles 339 338
    Research and development expenses   2,376     2,011  
    TOTAL OPERATING EXPENSES   8,972     7,591  
    OPERATING LOSS (5,225 ) (5,102 )
    Interest (expense)/income, net (115 ) 259
    Other expense   (201 )   -  
    LOSS BEFORE INCOME TAXES (5,541 ) (4,843 )
    Income tax provision   3     -  
    NET LOSS (5,544 ) (4,843 )
    NET LOSS PER SHARE
    BASIC $ (0.06 ) $ (0.06 )
    DILUTED $ (0.06 ) $ (0.06 )
    SHARES USED IN COMPUTING NET LOSS PER SHARE:
    BASIC   89,053     86,252  
    DILUTED   89,053     86,252  

    AKORN, INC.
    CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
    IN THOUSANDS
    (UNAUDITED)

     
    THREE MONTHS
    ENDED MARCH 31,
      2008     2007
    OPERATING ACTIVITIES
    Net loss $ (5,544 ) $ (4,843 )
    Adjustments to reconcile net loss to net cash used in operating activities:
    Depreciation and amortization 1,118 1,095
    Non-cash stock compensation expense 689 1,111
    Changes in operating assets and liabilities:
    Trade accounts receivable 1,041 2,650
    Inventories (2,700 ) (2,466 )
    Prepaid expenses and other current assets 233 212
    Other long-term assets 1,246 -
    Trade accounts payable (5,726 ) (619 )
    Accrued expenses and other liabilities   284     (982 )
    NET CASH USED IN OPERATING ACTIVITIES (9,359 ) (3,842 )
    INVESTING ACTIVITIES
    Purchases of property, plant and equipment (269 ) (500 )
    Purchase of intangible assets   -     (50 )
    NET CASH USED IN INVESTING ACTIVITIES (269 ) (550 )
    FINANCING ACTIVITIES
    Repayment of long-term debt (103 ) (96 )
    Restricted cash for Revolving Credit Agreement (2,050 ) -
    Proceeds from line of credit 6,743 -
    Proceeds from warrants exercised 37 382
    Proceeds under stock option and stock purchase plans   480     352  
    NET CASH PROVIDED BY FINANCING ACTIVITIES   5,107     638  
    DECREASE IN CASH AND CASH EQUIVALENTS (4,521 ) (3,754 )
    Cash and cash equivalents at beginning of period   7,948     21,818  
    CASH AND CASH EQUIVALENTS AT END OF PERIOD $ 3,427   $ 18,064  
    Amount paid for interest $ 175 $ 14
    Amount paid for income taxes $ 3 $ 1

     

    Contact:
    Akorn, Inc.
    Arthur S. Przybyl, President and CEO
    Jeffrey A. Whitnell, CFO
    (847) 279-6100

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