NORTHVALE, N.J., Aug. 14, 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 three months ended June 30, 2012.
Consolidated revenues were $0.6 million for the quarter, an increase of almost 20% when compared to the quarter ended March 31, 2012 exclusive of a milestone payment in the December quarter. This increase is the result of the continuing growth of the new revenue streams that have been created within the last fourteen months. All revenues during this quarter were generated from the recently launched phentermine and hydromorphone tablets which are distributed under license by TAGI Pharma, Lodrane D® capsules, which were co-developed with and sold by ECR Pharmaceuticals, and methadone tablets, which Elite manufactures on a contract basis for ThePharmaNetwork. Additionally, Elite has two ANDAs pending approval with the FDA and two manufacturing transfers pending approval by the FDA.
When compared to the comparable prior year period, Elite's revenues decreased 40%, from $1.0 million in revenues generated during the quarter ended June 30, 2011, the last quarter in which Elite manufactured and sold the Lodrane extended release products. Elite's operations generated $0.3 million negative cash flow during the quarter, compared with positive operating cash flows of $0.2 million for the comparable quarter of last year. These decreases in revenues and cash flows, when compared to the June 2011 quarter, were mainly 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, and the new revenue streams, while growing, have not yet achieved the levels of the Lodrane extended release products that were discontinued during the June 2011 quarter.
Consolidated loss from operations was $(0.5 million) for this quarter, compared with a loss from operations of $(0.3 million) in the comparable quarter of the prior year.
GAAP net loss for the quarter, including non-cash expenses relating to the accounting treatment of preferred share and warrant derivatives was $(10.5 million), compared to a GAAP net loss of $(30.7 million) for the comparable quarter of the prior year.
Basic and diluted loss per common share for the quarter was $(0.03) on a weighted average 337.3 million common shares outstanding, compared to a basic and diluted loss per common share of $(0.13) and a weighted average common shares outstanding of 232.0 million shares in the comparable quarter of the prior year. The increase in common shares outstanding are primarily due to conversion of preferred shares into common shares during that last 12 months.
Jerry Treppel, Chairman and CEO of Elite commented, "We have made progress on many fronts. As noted in prior paragraphs, our currently marketed products continue to grow generating more revenue for Elite. Our development projects with clients continue to move forward. The development of our abuse-resistance products continue to move forward. We are just now completing an FDA general cGMP review and several pre-approval inspection reviews of our facility. These are necessary to achieve our product approval goals as well as to begin commercial production in our new manufacturing space."
The Company will host a conference call to discuss the results of operations and provide an update on recent business developments on Wednesday, August 15, 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 August 29, 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 | ||
| June 30, 2012 | March 31, 2012 | |
| (Unaudited) | (Audited) | |
| CURRENT ASSETS | ||
| Cash and cash equivalents | $475,055 | $668,407 |
| Accounts receivable (net of allowance for doubtful accounts of zero) | 497,902 | 396,847 |
| Inventories (net of allowance of $93,338 and $93,338, respectively) | 362,965 | 304,882 |
| Prepaid expenses and other current assets | 83,813 | 127,704 |
| Total current assets | 1,419,735 | 1,497,840 |
| PROPERTY AND EQUIPMENT- net of accumulated depreciation and amortization of $4,774,257 and $4,659,670 , respectively | 4,185,471 | 4,284,786 |
| INTANGIBLE ASSETS – net of accumulated amortization of zero and zero, respectively | 658,795 | 642,848 |
| OTHER ASSETS | ||
| Investment in Novel Laboratories Inc. | 3,329,322 | 3,329,322 |
| Security deposits | 14,913 | 14,913 |
| Restricted cash – debt service for EDA bonds | 321,303 | 280,585 |
| EDA Bond offering costs, net of accumulated amortization of $96,885 and $93,030, respectively | 257,568 | 261,423 |
| Total other assets | 3,923,106 | 3,886,243 |
| TOTAL ASSETS | $10,187,107 | $10,311,717 |
| LIABILITIES AND STOCKHOLDERS (DEFICIT) | ||
| June 30, 2012 | March 31, 2012 | |
| (Unaudited) | (Audited) | |
| CURRENT LIABILITIES | ||
| EDA Bonds payable | $3,385,000 | $3,385,000 |
| Short term loans and current portion of long-term debt | 10,028 | 13,316 |
| Accounts payable and accrued expenses | 1,310,989 | 1,066,494 |
| Deferred revenues – current | 13,333 | 13,333 |
| Preferred share derivative interest payable | 43,555 | 70,966 |
| Total Current Liabilities | 4,762,903 | 4,549,109 |
| LONG TERM LIABILITIES | ||
| Deferred Revenues | 162,222 | 165,558 |
| Other long term liabilities | 88,464 | 87,404 |
| Derivative Liability – Preferred Shares | 11,490,340 | 8,506,106 |
| Derivative Liability – Warrants | 17,041,072 | 11,987,222 |
| Total Long-Term Liabilities | 28,782,098 | 20,746,290 |
| Total Liabilities | 33,545,001 | 25,295,399 |
| COMMITMENTS AND CONTINGENCIES: | ||
| STOCKHOLDERS (DEFICIT) | ||
| Common Stock – par value of $0.001, Authorized 690,000,000 Issued and outstanding – 346,216,619 and 331,649,728 shares, respectively | 346,217 | 331,650 |
| Additional paid-in capital | 117,044,126 | 114,910,812 |
| Accumulated deficit | (140,441,398) | (129,919,303) |
| Treasury stock, at cost (100,000 common shares) | (306,841) | (306,841) |
| Total Stockholders (Deficit) | (23,357,896) | (14,983,682) |
| TOTAL LIABILITIES AND STOCKHOLDERS (DEFICIT) EQUITY | $10,187,107 | $10,311,717 |
|
ELITE PHARMACEUTICALS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS |
||
|
Three Months Ended June 30, |
||
|
2012 (unaudited) |
2011 (unaudited) |
|
| REVENUES: | ||
| Manufacturing Revenues | $ 379,697 | $ 599,439 |
| Royalties and Profit Splits | 128,495 | 310,031 |
| Lab Fee Revenues | 70,364 | 80,506 |
| Total Revenues | 578,556 | 989,976 |
| Cost of Revenues | 454,364 | 425,368 |
| Gross Profit | 124,192 | 564,608 |
| OPERATING EXPENSES | ||
| Research and Development | 196,882 | 445,497 |
| General and Administrative | 364,961 | 324,596 |
| Non-cash compensation through issuance of stock options and warrants | 6,113 | 6,113 |
| Depreciation and amortization | 41,998 | 124,934 |
| Total Operating Expenses | 609,954 | 901,140 |
| (LOSS) FROM OPERATIONS | (485,762) | (336,532) |
| OTHER INCOME / (EXPENSES): | ||
| Interest expense, net | (58,539) | (57,370) |
| Change in fair value of outstanding warrant derivatives | (5,088,733) | (13,583,430) |
| Change in fair value of preferred share derivatives | (4,643,484) | (16,610,788) |
| Interest expense attributable to preferred share derivatives | (55,077) | (142,806) |
| Discount in Series E issuance attributable to beneficial conversion features | (187,500) | -- |
| Total Other Income / (Expense) | (10,033,332) | (30,394,394) |
| (LOSS) BEFORE PROVISION FOR INCOME TAXES | (10,519,095) | (30,730,926) |
| Provision for Income Taxes | 3,000 | 2,500 |
| (LOSS) ATTRIBUTABLE TO COMMON SHAREHOLDERS | $ (10,522,095) | $ (30,733,426) |
| BASIC AND DILUTED LOSS PER COMMON SHARE | $ (0.03) | $ (0.13) |
| WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING | 337,272,222 | 232,003,497 |
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.