-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, QBc0Pm9dPgWKOCNhfAghKWunjc2DwZL2mLPTmAFrSZhlK3TRUYsYFCSODIFY3+kw o2Zz+IsXoIMOkWhjY6N+Wg== 0000950124-03-003293.txt : 20031022 0000950124-03-003293.hdr.sgml : 20031022 20031022121307 ACCESSION NUMBER: 0000950124-03-003293 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20031015 ITEM INFORMATION: ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20031022 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CARACO PHARMACEUTICAL LABORATORIES LTD CENTRAL INDEX KEY: 0000887708 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 382505723 STATE OF INCORPORATION: MI FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-31773 FILM NUMBER: 03951312 BUSINESS ADDRESS: STREET 1: 1150 ELIJAH MCCOY DR CITY: DETROIT STATE: MI ZIP: 48202 BUSINESS PHONE: 3138718400 MAIL ADDRESS: STREET 1: 1150 ELIJAH MCCOY DRIVE CITY: DETROIT STATE: MI ZIP: 48202 8-K 1 k80220e8vk.txt CURRENT REPORT DATED OCTOBER 15, 2003 SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 8-K CURRENT REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 DATE OF REPORT (DATE OF EARLIEST EVENT REPORTED): OCTOBER 15, 2003 CARACO PHARMACEUTICAL LABORATORIES, LTD. (EXACT NAME OF REGISTRANT AS SPECIFIED IN CHARTER) MICHIGAN 38-2505723 (STATE OR OTHER JURISDICTION OF (I.R.S. EMPLOYER INCORPORATION) IDENTIFICATION NUMBER) 0-24676 (COMMISSION FILE NUMBER) 1150 ELIJAH MCCOY DRIVE, DETROIT, MICHIGAN 48202 (ADDRESS OF PRINCIPAL EXECUTIVE OFFICES) (313) 871-8400 (REGISTRANT'S TELEPHONE NUMBER, INCLUDING AREA CODE) ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS (c) Exhibits 99.1 October 15, 2003 Press Release ITEM 12. RESULTS OF OPERATIONS AND FINANCIAL CONDITION On October 15, 2003, registrant announced its results of operations for the third quarter ended September 30, 2003 as set forth in the press release included as Exhibit 99.1 hereto. The information in this Current Report on Form 8-K, including the exhibit, is furnished pursuant to Item 12 and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended, or otherwise subject to the liabilities under that Section. Furthermore, the information in this Current Report on Form 8-K, including the exhibit, shall not be deemed to be incorporated by reference into the filings of the Company under the Securities Act of 1933, as amended, or the Securities Exchange Act of 1934, as amended. SIGNATURES Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. Dated: October 17, 2003 CARACO PHARMACEUTICAL LABORATORIES, LTD. (REGISTRANT) By: /s/ Jitendra N. Doshi ------------------------------ Jitendra N. Doshi, CEO 2 EXHIBIT INDEX Exhibit: Description: 99.1 October 15, 2003 Press Release 3 EX-99.1 3 k80220exv99w1.txt PRESS RELEASE DATED OCTOBER 15, 2003 EXHIBIT 99.1 DETROIT, Oct. 15, 2003 -- CARACO PHARMACEUTICAL LABORATORIES, LTD., (AMEX:CPD) posted its third consecutive quarter of profitability and record sales for the third quarter and the nine months ended September 30, 2003, Jitendra N. Doshi, Chief Executive Officer, reported today. Third-quarter results. Net income for the quarter ended September 30, 2003 rose 540% to $4.54 million, from year-earlier net income of $0.7 million, or $0.03 per share. The strong earnings growth came from a rise in sales. Net sales for the third quarter ended September 30, 2003 rose 108% to a record $12.3 million, from $5.9 million for the corresponding period in 2002. Gross profit for the third quarter ended September 30, 2003 was $7.84 million, significantly better than the $2.86 recorded for the corresponding period in 2002. Operating income similarly improved, rising 337% to $4.74 million in the third quarter ended September 30, 2003, from $1.09 million for the corresponding period in 2002. Nine-month results. Nine-month results were equally positive. Net income for the nine months ended September 30, 2003 rose to $11.07 million, or $0.44 per share, from a net loss of $1.72 million or $0.08 per share for the corresponding period in 2002. Sales were ahead of plan. Net sales for the nine months ended September 30, 2003 rose 122% to a record $32.9 million, from $14.83 million for the corresponding period in 2002. Gross profit for the nine months ended September 30, 2003 reached $19.79 million, from $7.38 million for the corresponding period in 2002. Operating income for the nine months ended September 30, 2003 was $12.08 million, versus an operating loss of $0.6 million for the corresponding period in 2002. However, the operating loss for the nine months ended September 30, 2002 included non-cash research and development expenses of approximately $2.8 million relating to 1,088,000 shares earned by Sun Pharmaceutical Industries Limited ("Sun Pharmaceutical") in connection with two products transferred to the Company by Sun Pharmaceutical pursuant to its then existing products agreement with the Company. In comparison, there were no non-cash research and development expenses for the nine months ended September 30, 2003. The Company has not filed any new ANDAs with the FDA for approval during the nine months ended September 30, 2003. In addition, the Company does not expect to file any new ANDAs with the FDA for approval during the fourth quarter of 2003. Although Sun Global and the Company entered into a products agreement in November 2002 (the "Products Agreement"), since such date, no products have yet been selected and agreed upon by the Company, the Independent Committee of Directors of the Company and Sun Global. While they are engaged in discussions, the Company has decided to perform research and development for certain products ("Products") (currently six) presented for consideration by Sun Global pursuant to the Products Agreement. However, if the Company does not select and accept any of such Products for itself for filing as ANDAs with the FDA, Sun Global will reimburse the Company for all of its research and development and other costs associated with such Product. Sun Global may then file the Product with the FDA in its name, and the Company and Sun Global may negotiate an agreement pursuant to which the Company 4 will manufacture and market the Product. The consideration payable to the Company will be no less favorable than what unrelated third parties would receive. Mr. Doshi said, "The third quarter was very positive for our Company and we are optimistic about the fourth quarter, and we are revising upward our sales guidance for the year to $45 million, which would represent a doubling of sales from 2002's $22.4 million." The Company received approval last month from the U.S. Food and Drug Administration (FDA) to manufacture and market tizanidine hydrochloride, a generic form of Elan Pharmaceutical's Zanaflex. Tizanidine is a short-acting muscle relaxant prescribed for the management of spasticity and has a U.S. market of approximately $240 million. The Company's formulary now stands at 18 drugs. Two additional drugs are pending FDA approval. Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures and distributes generic and private-label prescription drugs to the nation's largest wholesalers and distributors, drugstore chains and healthcare systems. The Company is affiliated with Mumbai, India-based Sun Pharmaceutical, India's fifth largest pharmaceutical company. Sun Pharmaceutical holds approximately 49% of Caraco's common stock. Safe Harbor. This news release contains forward-looking statements made pursuant to the safe-harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements are based on management's current expectations and are subject to risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. These risks and uncertainties are contained in the Corporation's filings with the Securities and Exchange Commission and include: information is of a preliminary nature and may be subject to adjustment, not obtaining or delays in obtaining FDA approval for new products, governmental restrictions on the sale of certain products, dependence on key personnel, development by competitors of new or superior products or cheaper products or new technology for the production of products, the entry into the market of new competitors, market and customer acceptance and demand for new pharmaceutical products, availability of raw materials, timing and success of product development and launches, integrity and reliability of the Corporation's data, lack of success of attaining full compliance with regard to regulatory and cGMP compliance, and other risks identified from time to time in the Corporation's reports and registration statements filed with the SEC, available free via EDGAR. The Corporation assumes no responsibility to update forward-looking statements. more (financial schedules follow) 5 CARACO PHARMACEUTICAL LABORATORIES, LTD. UNAUDITED STATEMENTS OF OPERATIONS
- ------------------------------------------------------------------------------------------------------- PARTICULARS NINE MONTHS ENDED THREE MONTHS ENDED 30-Sep 30-Sep 2003 2002 2003 2002 - ------------------------------------------------------------------------------------------------------- Net Sales 32,905,662 14,828,849 12,294,125 5,899,441 Cost of goods sold 13,112,198 7,448,809 4,458,785 3,035,340 ------------------------------------------------------- Gross profit 19,793,465 7,380,040 7,835,341 2,864,101 Selling, general & administrative expenses 5,689,566 2,648,202 2,599,746 808,963 R&D cost 2,018,029 2,541,449 491,310 969,947 R&D cost - Affiliate - 2,790,720 - - ------------------------------------------------------- Operating income / (loss) 12,085,870 (600,331) 4,744,285 1,085,191 ------------------------------------------------------- Interest Interest expense (1,041,382) (1,130,898) (223,660) (384,917) Interest income 24,790 10,798 17,747 8,377 ------------------------------------------------------- Net interest expense (1,016,593) (1,120,100) (205,914) (376,540) ------------------------------------------------------- ------------------------------------------------------- Net income / (loss) 11,069,278 (1,720,431) 4,538,371 708,651 ======================================================= Net income / (loss) per common share ------------------------------------------------------- Basic 0.46 (0.08) 0.19 0.03 ------------------------------------------------------- Diluted 0.44 (0.08) 0.18 0.03 -------------------------------------------------------
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