NORTHVALE, N.J., June 30, 2011 (GLOBE NEWSWIRE) -- Elite Pharmaceuticals, Inc. (OTCBB:ELTP), a specialty pharmaceutical company dedicated to developing and commercializing oral controlled release product formulations and the manufacturing of generic pharmaceuticals, announced results for the fiscal year ended March 31, 2011.
Consolidated revenues were $4.3 million, an increase of 28% over last year's revenues of $3.3 million. Elite's operations generated $1.6 million in positive cash flow, compared with negative operating cash flows of $1.4 million last year. The substantial increases in revenues and cash flows, were almost solely derived from the manufacture, sale and lab services related to the Lodrane family of products, which were discontinued in April 2011, in accordance with an announcement by the US Food and Drug Administration (FDA) ordering the removal of approximately 500 cough/cold and allergy products including Lodrane from the U.S. market.
Consolidated loss from operations was $(0.9 million) for the 2011 fiscal year, compared with a loss from operations of $(1.9 million) in the prior year. Elite's reported operating loss this fiscal year includes $1.4 million in charges resulting from a recent decision by the FDA which would be detrimental to the Company. These decisions, which are being appealed, may significantly delay our market entry of two recently purchased ANDAs. Exclusive of these items, the Company would have reported a profit from operations for the year.
GAAP net loss, including non-cash expenses relating to the accounting treatment of preferred share and warrant derivatives was $(13.6 million), compared to a GAAP net loss of $(8.1 million) in the prior year.
Basic and diluted loss per common share was $(0.14) on a weighted average 100.0 million common shares outstanding, this fiscal year, compared to a basic and diluted per common share of $(0.11) and a weighted average common shares outstanding of 75.6 million shares in the prior fiscal year.
Jerry Treppel, Chairman and CEO of Elite, commented, "I am extremely proud of all the employees at Elite who helped the Company complete an astonishing operational turnaround from the verge of bankruptcy to an operating profit. Of course we cannot control the decision-making process of the FDA which has negated much of our hard work. Nonetheless, we have generated other revenue producing opportunities and will continue to do so."
The Company will host a conference call to discuss the results of operations and provide an update on recent business developments on June 30, 2011 at 4:30PM EDT. Company executives will also conduct a question and answer session following their remarks.
| To access the conference call: | Domestic callers: (800) 346-7359 |
| International callers: (973) 528-0008 | |
| Conference Entry Code: 98840 |
A digital telephone replay will be available approximately one hour after the conclusion of the call for two weeks until July 14, 2011 by dialing:
| Domestic callers: (800) 332-6854 |
| International callers: (973) 528-0005 |
| Conference entry code: 98840 |
Financial Statements
| ELITE PHARMACEUTICALS, INC. AND SUBSIDIARIES | ||
| CONDENSED CONSOLIDATED BALANCE SHEETS | ||
| ASSETS | ||
| March 31, 2011 | March 31, 2010 | |
| (Audited) | (Audited) | |
| CURRENT ASSETS | ||
| Cash and cash equivalents | $1,825,858 | $578,187 |
| Accounts receivable (net of allowance for doubtful accounts of zero) | 571,667 | 404,961 |
| Inventories (net of allowance of $1,047,456 and $ 494,425, respectively) | 616,362 | 1,371,292 |
| Prepaid expenses and other current assets | 133,472 | 131,507 |
| Total current assets | 3,147,359 | 2,485,947 |
|
PROPERTY AND EQUIPMENT- net of accumulated depreciation and amortization of $4,189,618 and $3,840,279, respectively |
4,118,274 | 4,095,814 |
| INTANGIBLE ASSETS – net of accumulated amortization of zero and $76,434, respectively | 597,556 | 96,407 |
| OTHER ASSETS | ||
| Investment in Novel Laboratories Inc. | 3,329,322 | 3,329,322 |
| Security deposits | 28,377 | 14,652 |
| Restricted cash – debt service for EDA bonds | 291,420 | 294,836 |
| EDA Bond offering costs, net of accumulated amortization | ||
| of $78,898 and $64,767, respectively | 275,554 | 289,685 |
| Total other assets | 3,924,673 | 3,928,495 |
| TOTAL ASSETS | $11,787,862 | $10,606,663 |
| LIABILITIES AND STOCKHOLDERS (DEFICIT) | ||
| December 31, 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 | 13,105 | 82,302 |
| Accounts payable and accrued expenses | 935,797 | 986,777 |
| Customer deposits | 39,400 | -- |
| Deferred revenues – current | 13,333 | -- |
| Preferred share derivative interest payable | 282,680 | 306,440 |
| Total Current Liabilities | 4,669,315 | 4,760,519 |
| LONG TERM LIABILITIES | ||
| Deferred Revenues | 178,890 | -- |
| Long-term debt, less current portion | 6,717 | 19,823 |
| Other long term liabilities | 68,746 | -- |
| Derivative Liability – Preferred Shares | 14,192,329 | 7,924,763 |
| Derivative Liability – Warrants | 10,543,145 | 8,499,423 |
| Total Long-Term Liabilities | 24,989,827 | 16,444,009 |
| Total Liabilities | 29,659,142 | 21,204,528 |
| COMMITMENTS AND CONTINGENCIES: | ||
| STOCKHOLDERS (DEFICIT) | ||
| Common Stock – par value of $0.001, Authorized 355,516,558 | ||
| Issued and outstanding – 180,545,657 shares and 83,950,168 shares, respectively | 180,546 | 83,950 |
| Additional paid-in capital | 97,116,044 | 90,903,896 |
| Accumulated deficit | (114,861,029) | (101,278,870) |
| Treasury stock, at cost (100,000 common shares) | (306,841) | (306,841) |
| Total Stockholders (Deficit) | (17,871,280) | (10,597,865) |
| TOTAL LIABILITIES AND STOCKHOLDERS (DEFICIT) EQUITY | $11,787,862 | $10,606,663 |
| ELITE PHARMACEUTICALS, INC. AND SUBSIDIARIES | ||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||
| Years Ended | ||
| March 31, | ||
| 2011 | 2010 | |
| (audited) | (audited) | |
| REVENUES: | ||
| Manufacturing Revenues | $3,086,183 | $2,575,942 |
| Royalties | 831,538 | 763,938 |
| Lab Fee Revenues | 348,242 | 4,429 |
| Total Revenues | 4,265,963 | 3,344,299 |
| Cost of Revenues | 2,675,118 | 2,305,763 |
| Gross Profit | 1,590,845 | 1,038,536 |
| OPERATING EXPENSES | ||
| Research and Development | 1,385,211 | 794,433 |
| General and Administrative | 876,014 | 1,841,425 |
| Non-cash compensation through issuance of stock options and warrants | 42,016 | 125,004 |
| Depreciation and amortization | 173,364 | 213,995 |
| Total Operating Expenses | 2,476,605 | 2,974,857 |
| (LOSS) FROM OPERATIONS | (885,760) | (1,936,321) |
| OTHER INCOME / (EXPENSES): | ||
| Interest expense, net | (231,745) | (260,337) |
| Change in fair value of outstanding warrant derivatives | (1,297,998) | (3,792,130) |
| Change in fair value of preferred share derivatives | (10,416,376) | (283,920) |
| Interest expense attributable to dividends accrued to preferred share derivative liabilities | (1,259,480) | (1,271,254) |
| Discount in Series E issuance attributable to beneficial conversion features | (292,213) | (512,912) |
| Proceeds from litigation settlement | 500,000 | -- |
| Total Other Income / (Expense) | (12,997,812) | (6,120,553) |
| (LOSS) BEFORE PROVISION FOR INCOME TAXES | (13,883,570) | (8,056,874) |
| Credit for Income Taxes | 301,413 | -- |
| (LOSS) ATTRIBUTABLE TO COMMON SHAREHOLDERS | $(13,582,159) | $(8,056,874) |
| BASIC AND DILUTED LOSS PER COMMON SHARE | $(0.14) | $(0.11) |
| WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | 100,020,520 | 75,581,345 |
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. Elite has four ANDA products partnered with TAGI Pharma; one ANDA has launched, two ANDAs are in the process of a manufacturing site transfer and an additional ANDA is currently under review by the FDA. Elite's lead pipeline products, ELI-216, a once-daily abuse resistant oxycodone, and ELI-154, a once-daily oxycodone, are novel sustained release oral formulations of opioids 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. Elite also has partnered with Mikah Pharma to develop a new product and with Hi-Tech Pharmacal to develop an intermediate for a generic product. Elite operates a GMP and DEA registered facility for research, development, and manufacturing located in Northvale, NJ.
The Elite Pharmaceuticals, Inc. logo is available at http://www.globenewswire.com/newsroom/prs/?pkgid=8737
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.