-----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, IRCvDjMOTzfV+Q3GRDhdYAWiRSpqkne7ZaP98sms1P8JgZ0VzDTsb4uHkq9jQdEu 8oaPxJE0bJ52RszKklJEeA== 0001169232-05-002304.txt : 20050426 0001169232-05-002304.hdr.sgml : 20050426 20050426172817 ACCESSION NUMBER: 0001169232-05-002304 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20050426 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050426 DATE AS OF CHANGE: 20050426 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: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-31773 FILM NUMBER: 05774076 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 d63549_8-k.htm CURRENT REPORT

 

UNITED STATES

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

 

April 26, 2005

(Date of report)

 

CARACO PHARMACEUTICAL LABORATORIES, LTD.

(Exact name of registrant as specified in its charter)

 

 

Michigan

 

0-24676

 

38-2505723

 

 

(State or other jurisdiction of incorporation)

 

(Commission file number)

 

(I.R.S. employer identification no.)

 

 

1150 Elijah McCoy Drive, Detroit, Michigan 48202

(Address of principal executive offices)

 

(313) 871-8400

(Registrant’s telephone number, including area code)

 

Not Applicable

(Former name or former address, if changed since last report)

 

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

o 

Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)

 

o 

Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 140.14a-12)

 

o 

Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))

 

o 

Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

 

 


 

 

Item 2.02. Results of Operations and Financial Condition and Item 7.01. Regulation FD Disclosure

 

On April 26, 2005, registrant announced its unaudited preliminary results of operations for the quarter ended March 31, 2005, as set forth in the press release included as Exhibit 99.1 hereto, which is incorporated herein by reference.

 

Item 9.01. Financial Statements and Exhibits

 

c)

Exhibits.

 

Exhibit No.

Description

 

99.1              Press Release of Caraco Pharmaceutical Laboratories, Ltd., dated April 26, 2005 announcing unaudited preliminary 2004 year-end results of operations for the quarter ended March 31, 2005.

 

SIGNATURES

 

Pursuant to the requirements of the Securities Exchange Act of 1934, registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

 

CARACO PHARMACEUTICAL LABORATORIES, LTD.

 

 

Date:

March 31, 2005

By:  /s/Jitendra N. Doshi

 

Jitendra N. Doshi

Chief Executive Officer

 

 


 

 

Exhibit Index

 

 

99.1

Press Release of Caraco Pharmaceutical Laboratories, Ltd., dated April 26, 2005 announcing unaudited preliminary 2004 year-end results of operations for the quarter ended March 31, 2005.

 

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 EX-99.1 2 d63549_ex99-1.htm PRESS RELEASE

 

 

EXHIBIT 99.1

 

Contacts:

Caraco Pharmaceutical – Jitendra Doshi, Bob Kurkiewicz – P:313 871-8400

Marcotte Financial Relations – Mike Marcotte – P:248 656-3873

 

 

Caraco Declares Unaudited Preliminary Results for Q1 2005 (Transition Year)

Highest Ever Revenues of $17.3 Million, up 28%.

 

 

For Immediate Release

 

 

DETROIT, April 26, 2005 -- Caraco Pharmaceutical Laboratories, Ltd. (Amex: CPD) declared highest ever revenues of $17.3 million, up 28%, from Q1-2004, and net cash from operations of $4.7 million for Q-1 2005. After non-cash R&D expense of $10.2 million and total R&D expense of $11.8 million, the net loss was $4.6 million, Jitendra N. Doshi, Chief Executive Officer, announced today.

 

The Q-1 2005 unaudited preliminary results are being declared to facilitate statutory consolidation of Caraco results in the unaudited results of Sun Pharmaceutical Industries Limited, as of March 31, 2005.

 

Mr. Doshi said, “As stated earlier and as was expected, pricing pressures due to increased competition have resulted in lower prices and have adversely affected our margins. Management has and will continue to work diligently to counter this through increased sales volumes, better cost absorption of operational overheads, and cost reductions. In addition, the higher level of R&D activities has resulted in higher total R&D expense, during Q-1 2005.”

 

During Q-1 of 2005, Caraco selected seven additional products for development pursuant to the November 21, 2002 products agreement with Sun Pharma Global, Inc. With this, all 25 products to be transferred under this agreement have been selected.

 

Of these 25 products, 11 products have passed bio-equivalency studies and 14 are in various stages of development. Of the 11 products, 9 ANDAs have been filed with the FDA. There are currently 9 ANDAs pending FDA approval.

 

As previously disclosed, the Company has changed its fiscal year from December 31 to March 31, commencing in 2005. This is to enable the Company’s fiscal year to conform to the March 31 fiscal year of its parent company, Sun Pharmaceutical Industries Limited, of which Caraco is a 64 % subsidiary. The Company intends to file a transition report for the period January 1, 2005 through March 31, 2005 (Q-1 2005) on Form 10-K, no later than June 14, 2005.

 

Detroit-based Caraco Pharmaceutical Laboratories, Ltd., develops, manufactures and distributes generic and private-label prescription drugs to some of the nation’s largest wholesalers, distributors, drugstore chains, healthcare systems and state and federal agencies.

 

 

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Caraco Pharma

Q1-2005 preliminary/unaudited results

Page 2

 

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: that the information is of a preliminary nature and may be subject to further adjustment; not obtaining FDA approval for new products or delays in receiving FDA approvals; 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 or the entry into the market of new competitors; market and customer acceptance and demand for new pharmaceutical products; availability of raw materials in a timely manner, at competitive prices, and in required quantities; timing and success of product development and launch; integrity and reliability of the Company’s data; lack of success in attaining full compliance with regard to regulatory and cGMP compliance; experiencing difficulty in managing our recent rapid growth and anticipated future growth; dependence on limited customer base; occasional credits to certain customers reflecting price reductions on products previously sold to them and still available as shelf-stock; possibility of an incorrect estimate of charge-backs and the impact of such an incorrect estimate on net sales, gross profit and net income; dependence on few products generating majority of sales; product liability claims for which the Company may be inadequately insured; subjectivity in judgment of management in applying certain significant accounting policies derived based on historical experience, terms of contracts, our observations of trends of industry, information received from our customers and other sources, to estimate revenues, accounts receivable, allowances including chargebacks, rebates, income taxes, values of assets and inventories etc., litigation involving claims of patent infringement and other risks identified in our reports and registration statements filed with the Securities and Exchange Commission. These forward-looking statements represent our judgment as of the date of this report. We disclaim, however, any intent or obligation to update our forward-looking statements.

 

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