Exhibit 99.1
At the Company:
Akorn, Inc.
Arthur S. Przybyl
President and CEO
(847) 279-6100
Akorn, Inc.
Arthur S. Przybyl
President and CEO
(847) 279-6100
FOR IMMEDIATE RELEASE
Akorn, Inc. Reports Third Quarter 2005 Financial Results;
Expands Business Development Activities
Expands Business Development Activities
Buffalo Grove, IL, November 7, 2005– Akorn, Inc. (AMEX: AKN) today announced net sales of $11.0 million for the third quarter ended September 30, 2005 vs. $15.4 million in the comparable prior year period. The revenue shortfall as compared to last year’s third quarter was primarily due to IC-Green and Cyanide Antidote kit sales. IC-Green sales last year were positively impacted by stocking orders in anticipation of a planned manufacturing room shutdown for upgrade renovations by our third party contract manufacturer and Cyanide kit sales were positively impacted by one-time government orders.
For the third quarter ended September 30, 2005, the Company realized a gross profit of $3.7 million. On a year-over-year basis, Akorn improved its cash flow from operations. Net cash provided by (used in) operating activities for the third quarter and nine months ended September 30, 2005 were $2.7 million and $0.6 million, vs. ($0.7) million and ($1.9) million in the comparable prior year periods.
Highlights for the Third Quarter 2005 include:
• | The receipt of a Public Pre-Solicitation Notice from the Department of Health and Human Services (HHS) for the procurement of Calcium-DTPA and Zinc-DTPA. In early October 2005, the Pre-Solicitation Notice was supplemented by a Request for Proposal (RFP). The RFP provides for initial order quantities of 450,000 units of DTPA as well as an option to purchase an additional one million units of DTPA. |
• | The Food and Drug Administration (FDA) conducted an inspection in August 2005 of the Decatur, IL manufacturing facility. At the conclusion of this inspection, a Form 483 Notice of Findings was issued. The inspection results remain under review by the FDA. |
• | The signing of a consulting agreement with Drs. Elias Reichel and Brandon Busbee to develop AK-1015, a unique formulation of a therapeutic agent for ophthalmic surgeries or office-based procedures. |
• | The renewal of a Credit Agreement with LaSalle Bank National Association. The renewal extends the existing Agreement for an additional three years and increases the Revolving Commitment amount from $5.0 million to $10.0 million. |
Arthur S. Przybyl, Akorn’s President and Chief Executive Officer stated, “We continue to work on our primary business objectives:
1. | The procurement of a contract for Ca-DTPA and Zn-DTPA from the Department of Health and Human Services. We expect to obtain a signed contract and to begin shipping product in the fourth quarter of 2005. |
2. | The continued investment and expansion in new product development through external strategic partnerships. We currently have nine partnerships that have developed and are developing a total of 88 drug products, which are projected for market launch over the next two to five years. |
3. | The validation of our state-of-the-art lyophilization facility. We expect to complete the validation of the facility by December 31, 2005 and begin media fills in the first quarter of 2006. |
4. | The regulatory clearance of our Decatur, IL manufacturing facility. We were inspected by the FDA in August 2005, and the FDA review of that inspection is ongoing with a final resolution expected in the fourth quarter of 2005. |
5. | The continued improvement of our business model. In our drive to profitability, we continue to generate positive cash flow from operations. Our current ratio has improved to 2.30, and we expect to be in a position to retire our remaining debt instruments from our balance sheet by the end of the first quarter of 2006.” |
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. Such factors include, but are not limited to, risks and uncertainties relating to the resolution of the FDA compliance issues at our Decatur, Illinois manufacturing facility. Other factors besides those listed there could also adversely affect our results.
AKORN, INC.
CONDENSED CONSOLIDATED BALANCE SHEETS
IN THOUSANDS
(UNAUDITED)
CONDENSED CONSOLIDATED BALANCE SHEETS
IN THOUSANDS
(UNAUDITED)
SEPTEMBER 30, | DECEMBER 31, | |||||||
2005 | 2004 | |||||||
ASSETS | ||||||||
CURRENT ASSETS | ||||||||
Cash and cash equivalents | $ | 2,024 | $ | 4,110 | ||||
Trade accounts receivable (less allowance for doubtful accounts of $189 and $435 respectively) | 1,821 | 6,582 | ||||||
Inventories | 10,751 | 10,421 | ||||||
Prepaid expenses and other current assets | 1,364 | 1,280 | ||||||
TOTAL CURRENT ASSETS | 15,960 | 22,393 | ||||||
PROPERTY, PLANT AND EQUIPMENT, NET | 30,680 | 31,893 | ||||||
OTHER LONG-TERM ASSETS | ||||||||
Intangibles, net | 10,560 | 11,618 | ||||||
Other | 45 | 1,018 | ||||||
TOTAL OTHER LONG-TERM ASSETS | 10,605 | 12,636 | ||||||
TOTAL ASSETS | $ | 57,245 | $ | 66,922 | ||||
LIABILITIES AND SHAREHOLDERS’ EQUITY | ||||||||
CURRENT LIABILITIES | ||||||||
Current installments of debt and debt in default | $ | 2,850 | $ | 3,590 | ||||
Trade accounts payable | 2,118 | 5,397 | ||||||
Accrued compensation | 665 | 499 | ||||||
Accrued expenses and other liabilities | 1,315 | 1,674 | ||||||
TOTAL CURRENT LIABILITIES | 6,948 | 11,160 | ||||||
LONG-TERM LIABILITIES | ||||||||
Long-term debt, less current installments | 4,699 | 6,790 | ||||||
Other | 1,879 | 1,646 | ||||||
TOTAL LONG-TERM LIABILITIES | 6,578 | 8,436 | ||||||
TOTAL LIABILITIES | 13,526 | 19,596 | ||||||
SHAREHOLDERS’ EQUITY | ||||||||
Common stock, no par value — 150,000,000 shares authorized; 26,455,780 and 25,132,684 shares issued and outstanding at September 30, 2005 and December 31, 2004, respectively | 64,134 | 59,571 | ||||||
Series A Preferred Stock, $1.00 par value, 257,172 shares authorized and issued, 242,172 shares outstanding at September 30, 2005 and December 31, 2004 | 26,942 | 25,787 | ||||||
Series B Preferred Stock, $1.00 par value, 170,000 shares authorized, 141,000 shares issued, 120,800 outstanding at September 30, 2005 and 138,500 outstanding at December 31, 2004 | 11,998 | 13,109 | ||||||
Warrants to acquire common stock | 13,905 | 14,160 | ||||||
Accumulated deficit | (73,260 | ) | (65,301 | ) | ||||
TOTAL SHAREHOLDERS’ EQUITY | 43,719 | 47,326 | ||||||
TOTAL LIABILITIES AND SHAREHOLDERS’ EQUITY | $ | 57,245 | $ | 66,922 | ||||
AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
IN THOUSANDS, EXCEPT PER SHARE DATA
(UNAUDITED)
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS
IN THOUSANDS, EXCEPT PER SHARE DATA
(UNAUDITED)
THREE MONTHS ENDED | NINE MONTHS ENDED | |||||||||||||||
SEPTEMBER 30, | SEPTEMBER 30, | |||||||||||||||
2005 | 2004 | 2005 | 2004 | |||||||||||||
Revenues | $ | 10,985 | $ | 15,388 | $ | 33,744 | $ | 38,124 | ||||||||
Cost of sales | 7,317 | 8,614 | 21,881 | 24,012 | ||||||||||||
GROSS PROFIT | 3,668 | 6,774 | 11,863 | 14,112 | ||||||||||||
Selling, general and administrative expenses | 3,894 | 4,068 | 10,961 | 10,218 | ||||||||||||
Amortization and write-down of intangibles | 353 | 311 | 1,157 | 2,871 | ||||||||||||
Research and development expenses | 1,438 | 438 | 4,203 | 1,150 | ||||||||||||
TOTAL OPERATING EXPENSES | 5,685 | 4,817 | 16,321 | 14,239 | ||||||||||||
OPERATING INCOME (LOSS) | (2,017 | ) | 1,957 | (4,458 | ) | (127 | ) | |||||||||
Interest expense | (595 | ) | (996 | ) | (1,705 | ) | (3,709 | ) | ||||||||
Gain related to dispute settlements | — | 1,582 | — | 1,582 | ||||||||||||
Gain on Retirement of Debt | — | — | 1,212 | — | ||||||||||||
INCOME (LOSS) BEFORE INCOME TAXES | (2,612 | ) | 2,543 | (4,951 | ) | (2,254 | ) | |||||||||
Income tax provision (benefit) | 2 | (44 | ) | 17 | (42 | ) | ||||||||||
NET INCOME (LOSS) | (2,614 | ) | 2,587 | (4,968 | ) | (2,212 | ) | |||||||||
Preferred stock dividends and adjustments | (1,015 | ) | (33,318 | ) | (2,991 | ) | (33,318 | ) | ||||||||
NET LOSS AVAILABLE TO COMMON STOCKHOLDERS | $ | (3,629 | ) | $ | (30,731 | ) | $ | (7,959 | ) | $ | (35,530 | ) | ||||
NET LOSS PER SHARE: | ||||||||||||||||
BASIC AND DILUTED | $ | (0.14 | ) | $ | (1.49 | ) | $ | (0.31 | ) | $ | (1.76 | ) | ||||
SHARES USED IN COMPUTING NET LOSS PER SHARE: | ||||||||||||||||
BASIC AND DILUTED | 26,203 | 20,605 | 25,804 | 20,230 | ||||||||||||
AKORN, INC.
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
IN THOUSANDS
(UNAUDITED)
CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS
IN THOUSANDS
(UNAUDITED)
NINE MONTHS ENDED | |||||||||
SEPTEMBER 30 | |||||||||
2005 | 2004 | ||||||||
OPERATING ACTIVITIES | |||||||||
Net loss | $ | (4,968 | ) | $ | (2,212 | ) | |||
Adjustments to reconcile net loss to net cash used in operating activities: | |||||||||
Depreciation and amortization | 4,927 | 3,054 | |||||||
Amortization of deferred financing costs | 72 | 1,184 | |||||||
Amortization of debt discounts | 876 | 1,009 | |||||||
Write-down of long lived assets | — | 1,849 | |||||||
Gain related to dispute settlements | — | (1,582 | ) | ||||||
Prepayments to Strides Arcolab Limited | (1,500 | ) | (1,250 | ) | |||||
Gain on Retirement of Debt | (1,212 | ) | — | ||||||
Non-cash expenses related to preferred stock | — | 1,064 | |||||||
Non-cash stock compensation expense | 273 | — | |||||||
Changes in operating assets and liabilities: | |||||||||
Trade accounts receivable | 4,761 | (4,498 | ) | ||||||
Inventories | (330 | ) | (695 | ) | |||||
Prepaid expenses and other current assets | 480 | (122 | ) | ||||||
Trade accounts payable | (3,279 | ) | 356 | ||||||
Accrued expenses and other liabilities | 502 | (36 | ) | ||||||
NET CASH PROVIDED BY (USED IN) OPERATING ACTIVITIES | 602 | (1,879 | ) | ||||||
INVESTING ACTIVITIES | |||||||||
Purchases of property, plant and equipment | (744 | ) | (611 | ) | |||||
Purchase of intangible assets | (75 | ) | (60 | ) | |||||
Proceeds from the sale of investment | — | 2,000 | |||||||
NET CASH PROVIDED BY (USED IN) INVESTING ACTIVITIES | (819 | ) | 1,329 | ||||||
FINANCING ACTIVITIES | |||||||||
Repayment of long-term debt | (253 | ) | (6,650 | ) | |||||
Repayment of NeoPharm Debt | (2,500 | ) | — | ||||||
Net borrowings (payments) under lines of credit | — | (1,400 | ) | ||||||
Net proceeds from Series B offering | — | 13,044 | |||||||
Proceeds from Warrants | 150 | — | |||||||
Proceeds under stock option and stock purchase plans | 734 | 1,007 | |||||||
NET CASH PROVIDED BY (USED IN) FINANCING ACTIVITIES | (1,869 | ) | 6,001 | ||||||
INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS | (2,086 | ) | 5,451 | ||||||
Cash and cash equivalents at beginning of period | 4,110 | 218 | |||||||
CASH AND CASH EQUIVALENTS AT END OF PERIOD | $ | 2,024 | $ | 5,669 | |||||
Amount paid for interest (net of capitalized interest) | $ | 397 | $ | 408 | |||||
Amount paid/(refunded) for income taxes | 72 | (44 | ) |