Caraco Pharma (AMEX:CPD): Poised for a Turnaround Print
Saturday, 30 May 2009 13:30

On 5/28/09, Caraco Pharma (AMEX:CPD) reported its fiscal year 2009 (FY09) results and provided an update on .kwd_bloack{margin-top:0} the .container{width:960px; margin:0 auto} status of box-shadow: 0px -1px 10px 0px rgba(0,0,0,0.75);} a recently completed FDA inspection of .frt_arr{float:left;width:223px; height:503px; background-position:0 3px; background-repeat:no-repeat} the .header{height:100px; border-top:10px solid #472558; background:url(; overflow:hidden} Company's manufacturing facilities in Detroit, MI. Net sales for CPD declined by 4% for FY09 to a level of .lst_arr{float:left;width:223px; height:503px; background-position:right 3px; background-repeat:no-repeat} $337.2M (versus $350.4M for FY08). The Company cited lower sales of .kwd_bloack{float:left; width:514px; margin-top:50px} its manufactured products, price erosion for both manufactured + distributed generic drugs, and a voluntary product recall (of heart drug digoxin) during late FY09 for the .leftblk{float:left; overflow:hidden} revenue shortfall.

Net income decreased to $20.5M during FY09 compared to /*.inquire {text-align:right; padding-top:10px; color:#fff} $35.4M in the .leftblk img{float: left; margin-top:22px; *margin-top:18px; padding-right: 15px;} previous year while gross profits declined by 20% to $67.8M from $84.7M during FY08. While CPD acknowledged that gross profit margins may come down due to .inquire a {font-size:12px; font-weight:normal; color:#fff}*/ generic drug price erosion, CEO Daniel Movens expressed confidence in the Company's ability to offset the .domain_name{float:left; line-height:34px; font-size:26px; font-weight: normal; color:#fff; padding-top:27px; width:535px} long-term impact of .kwd_bloack h4{font-size:13px; line-height:18px; color:#ababab; padding-left: 4px; text-transform: uppercase; text-align: center;} declining margins by growing sales and expanding Caraco's product portfolio.

Caraco filed 10 Abbreviated New Drug Applications (ANDAs) relating to .sale-msg {background:#fff; color:#4b4b4b; text-align:center; font-size:14px; height:40px; width:100%; top:0; left:0} nine products with the #logo{float:right;width:300px;padding:15px 0 0} FDA during FY09 as compared to seven products filed in the previous year. The Company has a total of .kwd_bloack ul, .kwd_bloack ul li{float:left; text-align:center;width:514px;list-style:none} 29 ANDAs (relating to 25 products) pending approval by the #logo p{text-align:right;clear:both;padding:4px 2px 0 0; color:#aeaeae;} FDA, which includes four tentative approvals. CPD also submitted 10 other regulatory filings with the FDA related to .sale-msg a {text-decoration: none; color:#079ce9; font-size:14px; line-height:40px} new sources of .kwd_bloack ul{padding-top:9px} Active Pharmaceutical Ingredients and alternative manufacturing sites in order to .sale-msg a:hover, .inquire a:hover{text-decoration: underline} improve the #logo p a{color:#ffffff;font-size:11px;text-decoration:underline;} Company's costs on .kwd_bloack ul{padding-bottom:20px} certain products.

The CEO also provided an update on the status of a FDA inspection of the Company's Detroit manufacturing facilities stemming from an October 2008 warning letter. The FDA began its inspection of Caraco's quality control and production systems on .header, .bottom_rs ul{height:auto} 3/11/09 and concluded on .leftblk{float:none; padding:0 5px} 5/12/09. The FDA provided Caraco with a list of .kwd_bloack ul li{line-height:30px} observations (Form 483) from the #logo img{border:0 none;} inspection and the .searchbox{float:right; width:351px; height:30px; padding-top:38px} Company has committed to provide written response within 30 days (6/11/09).

Caraco does not expect to #footer-keys-bot{text-align:center;background:#373045; border-bottom:2px solid #776e99; line-height:28px; padding:20px 0; word-wrap:break-word; -webkit-box-shadow: 0px 1px 10px 0px rgba(0,0,0,0.75); receive any FDA approvals for new products from its Detroit facility until the .srch-txt{float:left; width:242px; height:28px; font-size:16px; line-height:28px; background:url( 7px 5px no-repeat #fff; color:#414141; padding: 0 5px 0 30px; border:1px solid #6f6f6f; outline:none} FDA reviews the .srch-btn{float:right; width:66px; height:30px; font-size:13px; color:#303030; border:1px solid #6f6f6f; margin-left:4px; _border:none; * border:none; outlin:none; cursor:pointer; Company's written response to -moz-box-shadow: 0px 1px 10px 0px rgba(0,0,0,0.75); the background: #ededed; Form 483 observations and makes a determination on .domain_name{line-height:33px; font-size:30px; float:left; width:74%; padding-top:29px; word-wrap:break-word} the status of the facility. The Company noted that changes were made earlier this year to box-shadow: 0px 1px 10px 0px rgba(0,0,0,0.75);} Caraco's leadership team for both manufacturing and