NORTHVALE, N.J., Aug. 16, 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 quarter ended June 30, 2011.
Consolidated revenues were $1.0 million, an increase of 19% over last year's revenues of $0.8 million. Elite's operations generated $0.2 million in positive cash flow, compared with positive operating cash flows of $.1 million last year. The substantial increase in revenues and positive cash flow, were mostly derived from revenues earned from the launch of Elite's Phentermine 37.5mg tablets, and the manufacture, sale and lab services related to the Lodrane family of products, which were discontinued in April 2011. Consequently, management expects that revenues will show significant declines until new product launches and other revenue generating activities are able to replace lost Lodrane revenues.
Consolidated loss from operations was $(0.3 million) for the June 2011 quarter, compared with a loss from operations of $(0.1 million) in the prior year. The increased operating loss was primarily the result of the allocation of available resources from commercial operations to product development to replace the discontinued Lodrane family of products with new products and revenue streams.
GAAP net loss, including non-cash expenses relating to the accounting treatment of preferred share and warrant derivatives was $(30.7 million), compared to a GAAP net loss of $(4.8 million) in the prior year. The substantial increase in the GAAP Net Loss was the result of non-cash derivative expenses incurred a result of a significant increase in the closing price of ELTP shares at quarter end, as compared to the closing price as at the prior quarter's end.
Basic and diluted loss per common share was $(0.13) on a weighted average 232.0 million common shares outstanding, this June 2011 quarter, compared to a basic and diluted loss per common share of $(0.05) and a weighted average common shares outstanding of 87.1 million shares in the prior year.
Jerry Treppel, Chairman and CEO of Elite commented, "Everyone at Elite labors with the knowledge that much of their efforts of the past two years which engineered an unprecedented corporate turnaround, has been hampered by the loss of the Lodrane products. Nonetheless our employees are helping the company move forward to what we hope is an even brighter future." The Company will host a conference call to discuss the results of operations and provide an update on recent business developments on August 16, 2011 at 2:00 PM 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 August 30, 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 | ||
June 30, 2011 | March 31, 2011 | |
(Unaudited) | (Audited) | |
CURRENT ASSETS | ||
Cash and cash equivalents | $1,759,451 | $1,825,858 |
Accounts receivable (net of allowance for doubtful accounts of zero) | 513,532 | 571,667 |
Inventories (net of allowance of $942,337 and $ 494,425, respectively) | 312,025 | 616,362 |
Prepaid expenses and other current assets | 87,694 | 133,472 |
Total current assets | 2,672,702 | 3,147,359 |
PROPERTY AND EQUIPMENT-net of accumulated depreciation and amortization of $4,311,020 and $3,838,297, respectively | 4,231,512 | 4,118,274 |
INTANGIBLE ASSETS – net of accumulated amortization of zero | 607,928 | 597,556 |
OTHER ASSETS | ||
Investment in Novel Laboratories Inc. | 3,329,322 | 3,329,322 |
Security deposits | 28,377 | 28,377 |
Restricted cash – debt service for EDA bonds | 348,367 | 291,420 |
EDA Bond offering costs, net of accumulated amortization | ||
of $82,431 and $68,300, respectively | 272,021 | 275,554 |
Total other assets | 3,978,087 | 3,924,673 |
TOTAL ASSETS | $11,490,229 | $11,787,862 |
LIABILITIES AND STOCKHOLDERS (DEFICIT) | ||
June 30, 2011 | March 31, 2011 | |
(Unaudited) | (Audited) | |
CURRENT LIABILITIES | ||
EDA Bonds payable | $3,385,000 | $3,385,000 |
Short term loans and current portion of long-term debt | 13,528 | 13,105 |
Accounts payable and accrued expenses | 1,071,097 | 935,797 |
Customer deposits | --- | 39,400 |
Deferred revenues – current | 13,333 | 13,333 |
Preferred share derivative interest payable | 142,805 | 282,680 |
Total Current Liabilities | 4,625,763 | 4,669,315 |
LONG TERM LIABILITIES | ||
Deferred Revenues | 175,557 | 178,890 |
Long-term debt, less current portion | 75,129 | 75,463 |
Derivative Liability – Preferred Shares | 21,329,402 | 14,192,329 |
Derivative Liability – Warrants | 24,126,576 | 10,543,145 |
Total Long-Term Liabilities | 45,706,664 | 24,989,827 |
Total Liabilities | 50,332,427 | 29,659,142 |
STOCKHOLDERS (DEFICIT) | ||
Common Stock – par value of $0.001, Authorized 355,516,558 | ||
Issued and outstanding – 243,363,531 shares and 180,545,657 shares, respectively | 243,364 | 180,546 |
Additional paid-in capital | 106,815,734 | 97,116,044 |
Accumulated deficit | (145,594,455) | (114,861,029) |
Treasury stock, at cost (100,000 common shares) | (306,841) | (306,841) |
Total Stockholders (Deficit) | (38,842,198) | (17,871,280) |
TOTAL LIABILITIES AND STOCKHOLDERS (DEFICIT) EQUITY | $11,490,229 | $11,787,862 |
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARIES | |||
CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | |||
Three Months Ended June 30, |
|||
2011 (Unaudited) |
2010 (Unaudited) |
||
REVENUES: | |||
Manufacturing Revenues | $ 599,439 | $ 567,069 | |
Royalties and License Fees | 310,031 | 181,034 | |
Lab Fee Revenues | 80,506 | 83,817 | |
Total Revenues | 989,976 | 831,920 | |
Cost of Revenues | 425,368 | 411,671 | |
Gross Profit | 564,608 | 420,249 | |
OPERATING EXPENSES | |||
Research and Development | 445,497 | 165,008 | |
General and Administrative | 324,596 | 258,321 | |
Non-cash compensation through issuance of stock options and warrants | 6,113 | 15,358 | |
Depreciation and amortization | 124,934 | 78,331 | |
Total Operating Expenses | 901,140 | 517,018 | |
(LOSS) FROM OPERATIONS | (336,532) | (96,769) | |
OTHER INCOME / (EXPENSES): | |||
Interest expense, net | (57,370) | (58,069) | |
Change in fair value of outstanding warrant derivatives | (13,583,430) | 1,823,701 | |
Change in fair value of preferred share derivatives | (16,610,788) | (6,074,338) | |
Interest expense attributable to dividends accrued to preferred share derivative liabilities | (142,806) | (363,919) | |
Total Other Income / (Expense) | (30,394,394) | (4,672,625) | |
(LOSS) BEFORE PROVISION FOR INCOME TAXES | (30,730,926) | (4,769,394) | |
Provision for Income Taxes | 2,500 | --- | |
(LOSS) ATTRIBUTABLE TO COMMON SHAREHOLDERS | $(30,733,426) | $(4,769,394) | |
BASIC AND DILUTED LOSS PER COMMON SHARE | $ (0.13) | $ (0.05) | |
WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | 232,003,497 | 87,094,071 | |
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.
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.