NORTHVALE, N.J., Aug. 17, 2010 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. (OTCBB:ELTP), a specialty pharmaceutical company dedicated to developing and commercializing oral sustained and controlled release product formulations, announced results for the fiscal first quarter ended June 30, 2010.
Consolidated revenues for the first quarter of fiscal 2011 were $831,920 compared to $813,875 for the first quarter of fiscal 2010. All revenues are derived from the manufacture and sale of the Lodrane family of products. Manufacturing revenues were $567,069 compared to $665,064 in first quarter of fiscal 2010. Manufacturing revenues were lower due to timing differences in batch manufacturing and shipments. For the first time the company recorded revenues of $83,817 from lab fees which consist of product stability testing services for the Lodrane products. There was no such revenue in last year's first fiscal quarter. This is a new source of revenue for the company and is expected to continue going forward. Royalty revenue of $181,034 increased 22% over last year's royalty revenue of $148,811 due to growth in sales of the products. Loss from operations for the first quarter of fiscal 2011 was $96,769 compared to a loss of $876,659 for the same period in fiscal 2010. The decrease in loss from operations represents the efforts by management to increase manufacturing efficiency and reduce operating costs. Basic GAAP net loss per share was ($0.05) for first quarter of fiscal 2011 and is primarily due to $4.7 million in non-cash expenses related to the accounting treatment of preferred share derivatives and the fair value of warrant derivatives. This charge will vary depending on the price of the company's common shares at the end of each quarter.
Cash flow from operations, which excludes non-cash charges for depreciation and amortization and compensation, was a positive $50,151 for the first quarter of fiscal 2011 compared to a negative ($479,161) for the comparable period in fiscal 2010. Cash as of June 30, 2010 was $389,884.
Financial Statements
|
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS |
||
| ASSETS | ||
| June 30, 2010 | March 31, 2010 | |
| (Unaudited) | (Audited) | |
| CURRENT ASSETS | ||
| Cash and cash equivalents | $389,884 | $578,187 |
| Accounts receivable, (net of allowance for doubtful accounts of zero) | 294,851 | 404,961 |
| Inventories (net of allowance of $494,425 and $ 494,425, respectively) | 1,296,444 | 1,371,292 |
| Prepaid expenses and other current assets | 87,339 | 131,507 |
| Total current assets | 2,068,517 | 2,485,143 |
| PROPERTY AND EQUIPMENT, net of accumulated | ||
| depreciation and amortization of $3,838,297 and $3,840,279, respectively | 3,959,878 | 4,095,814 |
| INTANGIBLE ASSETS – net of accumulated amortization of zero | 338,119 | 96,407 |
| OTHER ASSETS | ||
| Investment in Novel Laboratories Inc. | 3,329,322 | 3,329,322 |
| Security deposits | 27,778 | 14,652 |
| Restricted cash – debt service for EDA bonds | 351,377 | 294,836 |
| EDA Bond offering costs, net of accumulated amortization | ||
| of $68,300 and $64,767, respectively | 286,152 | 289,685 |
| Total other assets | 3,994,629 | 4,024,902 |
| TOTAL ASSETS | $10,361,144 | $10,606,663 |
| LIABILITIES AND STOCKHOLDERS (DEFICIT) EQUITY | ||
| June 30, 2010 | March 31, 2010 | |
| (Unaudited) | (Audited) | |
| CURRENT LIABILITIES | ||
| EDA Bonds payable | $3,385,000 | $3,385,000 |
| Short term loans and current portion of long-term debt | 12,061 | 82,302 |
| Accounts payable and accrued expenses | 954,096 | 986,777 |
| Preferred share derivative interest payable | 363,919 | 306,440 |
| Total Current Liabilities | 4,715,076 | 4,760,519 |
| LONG TERM LIABILITIES | ||
| Long-term debt, less current portion | 16,706 | 19,823 |
| Derivative Liability – Preferred Shares | 13,999,102 | 7,924,763 |
| Derivative Liability – Warrants | 6,675,722 | 8,499,423 |
| Total Long-Term Liabilities | 20,691,530 | 16,444,009 |
| Total Liabilities | 25,406,606 | 21,204,528 |
| COMMITMENTS AND CONTINGENCIES: | ||
| STOCKHOLDERS (DEFICIT) EQUITY | ||
| Common Stock – par value of $0.001, Authorized 355,516,558 | ||
| 87,353 | 83,950 | |
| Additional paid-in capital | 91,222,292 | 90,903,896 |
| Accumulated deficit | (106,048,266) | (101,278,870) |
| Treasury stock, at cost (100,000 common shares) | (306,841) | (306,841) |
| Total Stockholders (Deficit) / Equity | (15,045,462) | (10,597,865) |
| TOTAL LIABILITIES AND STOCKHOLDERS (DEFICIT) EQUITY | $10,361,144 | $10,606,663 |
| ELITE PHARMACEUTICALS, INC. AND SUBSIDIARIES | ||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||
| Three Months Ended | ||
| June 30, | ||
| 2010 | 2009 | |
| (unaudited) | (unaudited) | |
| REVENUES: | ||
| Manufacturing Revenues | $567,069 | $665,064 |
| Lab Fee Revenues | 83,817 | -- |
| Royalties | 181,034 | 148,811 |
| Total Revenues | 831,920 | 813,875 |
| Cost of Revenues | 411,671 | 862,000 |
| Gross Profit | 420,249 | (48,125) |
| OPERATING EXPENSES | ||
| Research and Development | 165,008 | 251,092 |
| General and Administrative | 258,321 | 396,537 |
| Non-cash compensation through issuance of stock options and warrants | 15,358 | 55,363 |
| Depreciation and amortization | 78,331 | 125,542 |
| Total Operating Expenses | 517,018 | 828,534 |
| LOSS FROM OPERATIONS | (96,769) | (876,659) |
| OTHER INCOME / (EXPENSES): | ||
| Interest expense | (58,069) | (69,979) |
| Change in fair value of outstanding warrant derivatives | 1,823,701 | 154,326 |
| Change in fair value of preferred share derivatives | (6,074,338) | 2,561,527 |
| Interest expense attributable to dividends accrued to preferred share derivative liabilities | (363,919) | (359,021) |
| Discount in Series E issuance attributable to beneficial conversion features | -- | (258,700) |
| Total Other Expense | (4,672,625) | 2,028,153 |
| INCOME / (LOSS) BEFORE PROVISION FOR INCOME TAXES | $(4,769,394) | $1,151,494 |
| Provision for Income Taxes | -- | -- |
| NET INCOME / (LOSS) | (4,711,915) | 1,151,494 |
| NET INCOME / (LOSS) ATTRIBUTABLE TO COMMON SHAREHOLDERS | $(4,769,394) | $1,151,494 |
| NET INCOME / (LOSS) PER SHARE | ||
| BASIC | $(0.05) | $0.02 |
| DILUTED | $(0.05) | $0.01 |
| WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | ||
| BASIC | 87,094,071 | 66,240,476 |
| DILUTED | 128,304,240 | |
About Elite Pharmaceuticals, Inc.
Elite Pharmaceuticals, Inc. develops oral sustained and controlled release products. Elite's strategy includes assisting partner companies in the life cycle management of products to improve off-patent drug products and developing generic versions of controlled release drug products with high barriers to entry. Two of Elite's products, Lodrane 24® and Lodrane 24D®, are marketed by a partner, ECR Pharmaceuticals, for allergy treatment. Elite's lead pipeline products are novel sustained release oral formulations of oxycodone for the treatment of chronic pain, which address two of the limitations of existing oral opioids: the provision of consistent relief of baseline pain levels and deterrence of potential abuse. Both products, ELI-216, a once-daily abuse resistant oxycodone, and ELI-154, a once-daily oxycodone, are in late-stage development. Elite, with partners, also has an ANDA filed with the FDA for a generic equivalent of a pain product and has a generic gastrointestinal drug product in clinical development. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
This news release contains forward-looking statements, including those related to the preliminary nature of the clinical program results and the potential for further product development, that involve known and unknown risks, delays, uncertainties and other factors not under the control of Elite, which may cause actual results, performance or achievements of the companies to be materially different from the results, performance or other expectations implied by these forward-looking statements. In particular, because substantial future testing will be required prior to approval, the results described above may not be supported by additional data or by the results of subsequent trials. These risks and other factors, including the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, and intellectual property protections and defenses, are discussed in Elite's filings with the Securities and Exchange Commission such as the 10K, 10Q and 8K reports. Elite undertakes no obligation to update any forward-looking statements.