توصية شراء ( CPD ) [الأرشيف] - منتديات أعمال الخليج

سيف الخيال

27-01-2004, Tue 5:21 PM

Caraco Meets $45 Million Revenue Target for 2003
PR Newswire - January 27, 2004 09:00
2004 Revenues Expected to Grow 20% to 25% Technology Transfer Agreement Amended Seven Products Selected One New ANDA Filed with FDA

DETROIT, Jan 27, 2004 /PRNewswire-FirstCall via COMTEX/ -- Caraco Pharmaceutical Laboratories, Ltd. (Amex: CPD) posted record revenues of just over $45 million for 2003, Jitendra N. Doshi, Chief Executive Officer, announced today.

"We are very pleased to have met our 2003 revenue guidance, which represents a 100%+ increase over 2002 revenues. Additionally, we are optimistic about our sales in 2004, and expect them to grow an additional 20% to 25% over 2003's," Mr. Doshi stated.

He added that Caraco has selected seven products for development, pursuant to the products agreement with Sun Pharma Global, Inc. dated November 21, 2002. The products agreement was recently amended by Caraco's Independent Committee of Directors to eliminate the provision requiring that the Independent Committee concur in the selection of each product and to provide, instead, that each product satisfy certain objective criteria developed by management and approved by the Independent Committee. All of the seven selected new products have satisfied the objective criteria.

As disclosed by the Company in October 2003, although no new products had been selected at that time, Caraco continued to work on development of the seven products, and has recently filed an ANDA for one of them with the FDA for approval. The bio-equivalency study for this product was completed in December 2003, and, accordingly, will result in a non-cash R&D charge of $3 million to $4 million to earnings during the fourth quarter of 2003. The non-cash charge will be based on the value of the preferred shares earned by Sun Pharma Global for such product under the products agreement.

Including this recent filing, three ANDAs are now pending FDA approval.

Mr. Doshi said that Caraco now intends to move aggressively to develop new products, and hopes to file a majority of the remaining six products with the FDA for approval in 2004. This would result in a substantial increase in the cash and non-cash R&D expenditures, and would significantly reduce earnings or cause a loss in 2004.

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.

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 further 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.