Elite Pharmaceuticals, Inc. Reports Financial Results for the Second Quarter of Fiscal 2013 Revenues From New Products Continue to Grow NORTHVALE, N.J., Nov. 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 fiscal second quarter ended September 30, 2012. Consolidated revenues were $0.6 million for the quarter, an increase of 131% when compared to the comparable quarter of the prior year. This increase is the result of the continuing growth of the new revenue streams that have been created within the last eighteen months. In addition, at the end of the quarter, Elite has received FDA approval for two new products, Phentermine 15mg capsules and Phentermine 30mg capsules although the launch of these products is dependent on resolution of the API issues discussed in our press release of October 12, 2012. Elite also currently has two products that are pending approval by the FDA for manufacturing transfer and a third undisclosed generic product under FDA review. Consolidate loss from operations was $(0.5 million) for this quarter, compared with a loss from operations $(0.6 million) in the comparable quarter of the prior year. GAAP net income for the quarter, including non-cash expenses relating to the accounting treatment of preferred share and warrant derivatives was $1.0 million, compared to a GAAP net income of $13.9 million for the comparable quarter of the prior year, with the difference mostly being due to changes in the value of preferred shares and warrant derivatives. Basic earnings per share was $0.00, on a weighted average of 348.3 million common shares outstanding, compared to a basic earnings per common share of $0.06 and a weighted average common shares outstanding of 248.2 million in the comparable quarter of the prior year. Fully diluted earnings per share was $0.00, on a weighted average diluted shares of 505.8 million, compared to fully diluted earnings per share of $0.03 and a weighted average diluted shares of 454.2 million in the comparable quarter of the prior year. The increase in common shares outstanding is primarily due to conversion of preferred shares into common shares during the last 12 months. Jerry Treppel, Chairman and CEO of Elite commented, "Our plan to increase revenues from product sales, which are inherently more stable and predictable than a milestone based revenue stream continues apace. We are in active discussions with our phentermine API supplier and are hopeful that a resolution can be reached, although we cannot predict if or when this might occur. We have manufactured larger batches of product in our new facility and begun limited packaging operations as well.We continue to move forward with the development of our abuse-resistant opioid products even as others in the field continue to have problems." The Company will host a conference call to discuss the results of operations and provide an update on recent business developments on Thursday, November 15, 2012 at 10:00 AM EST.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 November 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 September 30, March 31, 2012 2012 (Unaudited) (Audited) ASSETS CURRENT ASSETS Cash and cash equivalents $ 207,343 $ 668,407 Accounts receivable (net of allowance for doubtful 562,943 396,847 accounts of -0- and -0-, respectively) Inventories (net of reserve of $93,338 and 480,735 304,882 $93,338, respectively) Prepaid expenses and other current assets 112,711 127,704 Total Current Assets 1,363,732 1,497,840 PROPERTY AND EQUIPMENT, net of accumulated depreciation of $4,888,414 and $4,659,670, 4,172,280 4,284,786 respectively INTANGIBLE ASSETS – net of accumulated 666,163 642,848 amortization of $-0- and $-0--, respectively OTHER ASSETS Investment in Novel Laboratories, Inc. 3,329,322 3,329,322 Security deposits 14,314 14,913 Restricted cash – debt service for EDA bonds 274,031 280,585 EDA bond offering costs, net of accumulated 254,023 261,423 amortization of $100,429 and $93,339, respectively Total Other Assets 3,871,690 3,886,243 TOTAL ASSETS $ 10,073,865 $10,311,717 LIABILITIES AND STOCKHOLDERS' DEFICIT CURRENT LIABILITIES EDA bonds payable $ 3,385,000 $ 3,385,000 Short term loans and current portion of long-term 206,636 13,316 debt Accounts payable and accrued expenses 1,128,346 1,066,494 Deferred revenues – current 13,333 13,333 Preferred share derivative interest payable 28,760 70,966 Total Current Liabilities 4,762,075 4,549,109 LONG TERM LIABILITIES Deferred revenues 158,889 165,558 Other long term liabilities 89,497 87,404 Derivative liability – preferred shares 11,917,323 8,506,106 Derivative liability – warrants 14,947,419 11,987,222 Total Long Term Liabilities 27,113,128 20,746,290 TOTAL LIABILITIES 31,875,203 25,295,399 STOCKHOLDERS' DEFICIT Common stock – par value $0.001, Authorized 690,000,000 sharesIssued and outstanding – 349,664 331,650 349,664,279 shares and 331,649,728 shares, respectively Additional paid-in-capital 117,547,328 114,910,812 Accumulated deficit (139,391,489) (129,919,303) Treasury stock at cost (100,000 common shares) (306,841) (306,841) TOTAL STOCKHOLDERS' DEFICIT (21,801,338) (14,983,682) TOTAL LIABILITIES AND STOCKHOLDERS' DEFICIT $ 10,073,865 $10,311,717 ELITE PHARMACEUTICALS, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS THREE MONTHS ENDED SIX MONTHS ENDED September 30, September 30, 2012 2011 2012 2011 REVENUES Manufacturing Fees $ 466,020 $ 78,294 $ 845,716 $ 677,733 Royalties & Profit 154,168 100,069 282,663 410,000 Splits Lab Fee Revenues 14,329 95,769 84,693 176,275 Total Revenues 634,517 274,132 1,213,072 1,264,108 COSTS OF REVENUES 479,631 76,331 933,995 501,700 Gross Profit 154,886 197,801 279,077 762,408 OPERATING EXPENSES Research and Development 228,475 198,212 425,357 643,709 General and 401,174 476,897 766,135 801,494 Administrative Non-cash compensation through issuance of 15,133 6,113 21,246 12,226 stock options Depreciation and 25,372 108,181 67,370 233,115 Amortization Total Operating Expenses 670,154 789,403 1,280,108 1,690,544 (LOSS) FROM OPERATIONS (515,268) (591,602) (1,001,031) (928,136) OTHER INCOME / (EXPENSES) Interest expense, net (61,247) (57,931) (119,784) (115,301) Change in fair value of 2,093,653 10,497,037 (2,995,081) (3,086,393) warrant derivatives Change in fair value of preferred share (187,383) 4,196,187 (4,830,866) (12,414,600) derivatives Interest expense attributable to (28,823) (124,370) (83,901) (267,175) preferred share derivatives Discount in Series E issuance attributable to (250,000) --- (437,500) --- beneficial conversion features Total Other Income / 1,566,200 14,510,923 (8,467,132) (15,883,469) (Expense) INCOME (LOSS) BEFORE PROVISION FOR INCOME 1,050,932 13,919,321 (9,468,163) (16,811,605) TAXES PROVISION FOR INCOME 1,023 --- 4,023 2,500 TAXES NET INCOME (LOSS) ATTRIBUTABLE TO COMMON $ 1,049,909 $ 13,919,321 $ (9,472,186) $ (16,814,105) SHAREHOLDERS NET (LOSS) PER SHARE Basic $ 0.00 $ 0.06 $ (0.03) $ (0.07) Diluted $ 0.00 $ 0.03 $ (0.03) $ (0.07) WEIGHTED AVERAGE NUMBER OF COMMON SHARES OUTSTANDING Basic 348,298,807 248,247,253 342,712,859 240,189,326 Diluted 505,759,554 454,162,476 342,855,832 240,189,326 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 three commercial products being sold through a partner, one product produced for partners under contract manufacturing agreements, two additional products approved and pending launch, and three 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, inability to obtain necessary ingredients 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. CONTACT: For Elite Pharmaceuticals, Inc. Dianne Will, Investor Relations, 518-398-6222 Dianne@elitepharma.com www.elitepharma.com Elite Pharmaceuticals, Inc Logo
Elite Pharmaceuticals, Inc. Reports Financial Results for the Second Quarter of Fiscal 2013
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