NORTHVALE, N.J., June 29, 2012 (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, 2012.
Consolidated revenues were $2.4 million, a decrease of 43% over last year's revenues of $4.3 million. Elite's operations incurred $0.4 million in a negative cash flow, compared with positive operating cash flows of $1.6 million last year. The decreases in revenues and cash flows, were the result of the removal of the Lodrane Extended Release products from the US market, pursuant to a directive from the US Food and Drug Administration (FDA) which applied to approximately 500 products, including the Lodrane Extended Release Products. At the time of the FDA's directive, the Lodrane Extended Release Products comprised 97% of Elite's revenues.
Most of Elite's revenues during this fiscal year are the result of new products launched and new revenue streams created during fiscal 2012. The new products, all launched during this fiscal year, are phentermine tablets and hydromorphone tablets being distributed under license by TAGI Pharma and Lodrane D® capsules co-developed and sold by ECR Pharmaceuticals. Elite also initiated contract manufacturing of methadone tablets for ThePharmaNetwork this fiscal year. Additionally, Elite now has two ANDAs pending approval with the FDA and two manufacturing transfers pending approval by the FDA.
Consolidated loss from operations was $(2.0 million) for the 2012 fiscal year, compared with a loss from operations of $(0.9 million) in the prior year.
GAAP net loss, including non-cash expenses relating to the accounting treatment of preferred share and warrant derivatives was $(15.1 million), compared to a GAAP net loss of $(13.6 million) in the prior year.
Basic and diluted loss per common share was $(0.06) on a weighted average 259.2 million common shares outstanding, this fiscal year, compared to a basic and diluted per common share of $(0.14) and a weighted average common shares outstanding of 100.0 million shares in the prior fiscal year.
Jerry Treppel, Chairman and CEO of Elite commented, "We knew fiscal year 2012 would be a difficult year with the loss of the extended release Lodrane® products. Nonetheless, we were able generate $2.4 M in non-Lodrane 24® revenues in less than one year. This was achieved by the launch of four commercial products, contract product development, contract manufacturing and with growth continuing from the existing products. We also now have four additional products before the FDA. In addition to strengthening the balance sheet, we had conversions of preferred shares, had a very important patent issued and built out 15,000 square feet of manufacturing, packaging and inventory space – more than doubling our the manufacturing space. The focus of the future will be development of abuse resistant products utilizing our patented proprietary technology." The Company will host a conference call to discuss the results of operations and provide an update on recent business developments on Tuesday, July 3, 2012 at 10:00 AM 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 17, 2012 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, 2012 | March 31, 2011 | |
| (Audited) | (Audited) | |
| CURRENT ASSETS | ||
| Cash and cash equivalents | $ 668,407 | $ 1,825,858 |
| Accounts receivable (net of allowance for doubtful accounts of zero) | 396,847 | 571,667 |
| Inventories (net of allowance of $93,338 and $1,047,456, respectively) | 304,882 | 616,362 |
| Prepaid expenses and other current assets | 127,704 | 133,472 |
| Total current assets | 1,497,840 | 3,147,359 |
| PROPERTY AND EQUIPMENT- net of accumulated depreciation and amortization of $4,659,670 and $4,189,618 , respectively | 4,284,786 | 4,118,274 |
| INTANGIBLE ASSETS – net of accumulated amortization of zero and zero, respectively | 642,848 | 597,556 |
| OTHER ASSETS | ||
| Investment in Novel Laboratories Inc. | 3,329,322 | 3,329,322 |
| Security deposits | 14,913 | 28,377 |
| Restricted cash – debt service for EDA bonds | 280,585 | 291,420 |
| EDA Bond offering costs, net of accumulated amortization of 93,030 and $78,898, respectively | 261,423 | 275,554 |
| Total other assets | 3,886,243 | 3,924,673 |
| TOTAL ASSETS | $ 10,311,717 | $ 11,787,862 |
| LIABILITIES AND STOCKHOLDERS (DEFICIT) | ||
| March 31, 2012 | March 31, 2011 | |
| (Audited) | (Audited) | |
| CURRENT LIABILITIES | ||
| EDA Bonds payable | $3,385,000 | $3,385,000 |
| Short term loans and current portion of long-term debt | 13,316 | 13,105 |
| Accounts payable and accrued expenses | 1,066,494 | 935,797 |
| Customer deposits | --- | 39,400 |
| Deferred revenues – current | 13,333 | 13,333 |
| Preferred share derivative interest payable | 70,966 | 282,680 |
| Total Current Liabilities | 4,549,109 | 4,669,315 |
| LONG TERM LIABILITIES | ||
| Deferred Revenues | 165,558 | 178,890 |
| Other long term liabilities | 87,404 | 75,463 |
| Derivative Liability – Preferred Shares | 8,506,106 | 14,192,329 |
| Derivative Liability – Warrants | 11,987,222 | 10,543,145 |
| Total Long-Term Liabilities | 20,746,290 | 24,989,827 |
| Total Liabilities | 25,295,399 | 29,659,142 |
| COMMITMENTS AND CONTINGENCIES: | ||
| STOCKHOLDERS (DEFICIT) | ||
| Common Stock – par value of $0.001, Authorized 690,000,000 Issued and outstanding – 331,649,728 and 180,545,657 shares, respectively | 331,650 | 180,546 |
| Additional paid-in capital | 114,910,812 | 97,116,044 |
| Accumulated deficit | (129,919,303) | (114,861,029) |
| Treasury stock, at cost (100,000 common shares) | (306,841) | (306,841) |
| Total Stockholders (Deficit) | (14,983,682) | (17,871,280) |
| TOTAL LIABILITIES AND STOCKHOLDERS (DEFICIT) EQUITY | $10,311,717 | $11,787,862 |
| ELITE PHARMACEUTICALS, INC. AND SUBSIDIARIES | ||
| CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS | ||
| Years Ended | ||
| March 31, | ||
| 2012 | 2011 | |
| (audited) | (audited) | |
| REVENUES: | ||
| Manufacturing Revenues | $1,120,050 | $3,086,183 |
| Royalties | 648,211 | 831,538 |
| Lab Fee Revenues | 655,857 | 348,242 |
| Total Revenues | 2,424,118 | 4,265,963 |
| Cost of Revenues | 1,013,674 | 2,675,118 |
| Gross Profit | 1,410,444 | 1,590,845 |
| OPERATING EXPENSES | ||
| Research and Development | 1,735,689 | 1,385,211 |
| General and Administrative | 1,410,192 | 876,014 |
| Non-cash compensation through issuance of stock options and warrants | 24,453 | 42,016 |
| Depreciation and amortization | 206,248 | 173,364 |
| Total Operating Expenses | 3,376,582 | 2,476,605 |
| (LOSS) FROM OPERATIONS | (1,966,138) | (885,760) |
| OTHER INCOME / (EXPENSES): | ||
| Interest expense, net | (229,592) | (231,745) |
| Change in fair value of outstanding warrant derivatives | (1,444,075) | (1,297,998) |
| Change in fair value of preferred share derivatives | (11,227,957) | (10,416,376) |
| Interest expense attributable to dividends accrued to preferred share derivative liabilities | (424,465) | (1,259,480) |
| Discount in Series E issuance attributable to beneficial conversion features | (250,000) | (292,213) |
| Proceeds from litigation settlement | --- | 500,000 |
| Total Other Income / (Expense) | (13,576,088) | (12,997,812) |
| (LOSS) BEFORE PROVISION FOR INCOME TAXES | (15,542,226) | (13,883,570) |
| Credit for Income Taxes | 483,952 | 301,413 |
| (LOSS) ATTRIBUTABLE TO COMMON SHAREHOLDERS | $(15,058,274) | $(13,582,159) |
| BASIC AND DILUTED LOSS PER COMMON SHARE | ($0.06) | ($0.14) |
| WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | 259,163,279 | 100,020,520 |
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 commercial products with five additional products under review, pending approval by the FDA. Elite's lead pipeline products include abuse resistant opioids utilizing the company's patented proprietary technology, and a once-daily opioid. They are 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, with Hi-Tech Pharmacal to develop an intermediate for a generic product, and a Hong Kong based company to develop a branded product for the United States market and its territories. 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" within the meaning of the Private Securities Litigation Reform Act of 1995. Including those related to the effects, if any, on future results, performance or other expectations that may have some correlation to the subject matter of this press release, readers are cautioned that such forward-looking statements involve risks and uncertainties including, without limitation, delays, uncertainties and other factors not under the control of Elite, which may cause actual results, performance or achievements of Elite to be materially different from the results, performance or other expectations that may be implied by these forward-looking statements These risks and other factors, including, without limitation, the timing or results of pending and future clinical trials, regulatory reviews and approvals by the Food and Drug Administration and other regulatory authorities, intellectual property protections and defenses, and the Company's ability to operate as a going concern, are discussed in Elite's filings with the Securities and Exchange Commission, including its reports on forms 10-K, 10-Q and 8-K. Elite undertakes no obligation to update any forward-looking statements.