-----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, MFmK6VHKtG4Xi1VdKmk9Qms9RWxYBqznxMXTnd1fR3IK6diCVJsHYXNhJypyRUAx YCf6Q2PUqptk4bkFLJn0ig== 0000897101-03-000770.txt : 20030716 0000897101-03-000770.hdr.sgml : 20030716 20030716080355 ACCESSION NUMBER: 0000897101-03-000770 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20030716 ITEM INFORMATION: Regulation FD Disclosure FILED AS OF DATE: 20030716 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ST JUDE MEDICAL INC CENTRAL INDEX KEY: 0000203077 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 411276891 STATE OF INCORPORATION: MN FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-12441 FILM NUMBER: 03788248 BUSINESS ADDRESS: STREET 1: ONE LILLEHEI PLAZA CITY: ST PAUL STATE: MN ZIP: 55117 BUSINESS PHONE: 6514832000 MAIL ADDRESS: STREET 1: ONE LILLEHEI PLAZA CITY: ST PAUL STATE: MN ZIP: 55117 8-K 1 stjude033027_8k.txt 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 Date of Report (Date of earliest event reported) July 16, 2003 ------------- ST. JUDE MEDICAL, INC. ---------------------- (Exact name of registrant as specified in its chapter) Minnesota 0-8672 41-1276891 - ---------- ------ ---------- (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification No.) One Lillehei Plaza, St. Paul, MN 55117 - -------------------------------- ----- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (651) 483-2000 -------------- Not applicable -------------- (Former name or former address, if changed since last report) Item 9. Regulation FD Disclosure Reference is made to the Registrant's Press Release, dated July 16, 2003, which is included herewith as Exhibit 1. The attached Exhibit is furnished pursuant to Item 12 on Form 8-K. SIGNATURE Pursuant to the requirements of the Securities and Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized. ST. JUDE MEDICAL, INC. Date: July 16, 2003 By: /s/ Kevin T. O'Malley ------------- --------------------- Kevin T. O'Malley Vice President and General Counsel EXHIBIT INDEX Exhibit Description of Exhibit - ------- ---------------------- 1 Press Release, dated July 16, 2003 EX-99.1 3 stjude033027_ex-1.txt Exhibit 1 - --------- ST. JUDE MEDICAL REPORTS RECORD SECOND QUARTER RESULTS ------------------------------------------------------ SALES INCREASE 23% LED BY ICD AND ANGIO-SEAL PRODUCT LINES ---------------------------------------------------------- St. Paul, MN, July 16, 2003 -- St. Jude Medical, Inc. (NYSE: STJ) today reported record second quarter 2003 sales and earnings. Second quarter 2003 net sales of $495 million represent a $91 million or 23% increase compared to the $404 million reported by the Company in the second quarter of 2002. Favorable foreign currency translation comparisons increased second quarter sales by $19 million. First half 2003 net sales were $936 million, an increase of $160 million or 21% over the $776 million reported in the first half of 2002. Favorable foreign currency translation comparisons increased first half 2003 sales by about $35 million. Net earnings for the second quarter of 2003 were $82 million, a $12 million or 17% increase over the $70 million reported in the second quarter of 2002. Earnings per diluted share were $.43 in the second quarter of 2003, a 13% increase over the $.38 per diluted share reported in the second quarter of 2002. Net earnings for the first half of 2003 were $162 million, a $30 million or 23% increase over the $132 million reported in the first half of 2002. Earnings per diluted share were $.86 for the first half of 2003, a 19% increase over the $.72 per share reported in the first half of 2002. Commenting on these financial results, St. Jude Medical President and Chief Operating Officer Daniel J. Starks, said, "Second quarter results were consistent with our overall expectations. Sales of $495 million represent a 23% increase over last year's second quarter and were a result of strong performance across multiple product lines. Earnings of $.43 per diluted share were consistent with our expectations and 13% higher than last year's second quarter, while year-to-date earnings of $.86 per diluted share were 19% greater than the first half of 2002. Another strong cash flow quarter allowed us to increase our cash reserves while internally funding a portion of the acquisition of Getz Japan and the Epicor Medical investment." On April 1, St. Jude Medical announced the completion of the acquisition of Getz Bros. Co., Ltd., the largest distributor of St. Jude Medical products in Japan, the world's second largest medical technology market. The Company now has a significant direct presence in Japan, complemented by other longstanding Japanese distributor relationships. Second quarter results reflect the sales contributions of Getz to St. Jude Medical. On June 30, the Company announced regulatory and reimbursement approvals by the Ministry of Health, Labor and Welfare (MHLW) in Japan of the St. Jude Medical Integrity(R) Micro pacemaker family, offering Japanese physicians the smallest physical dimensions and most advanced features of any pacemaker available in that market. In the coming year, St. Jude Medical plans to introduce several other key products in Japan. Starks added, "Our high-voltage cardiac rhythm management business continued the strong momentum we have seen since early 2001. ICD sales for the quarter of $106 million represented an increase of more than 42% over the second quarter of 2002. The St. Jude Medical Epic(TM) Plus, the first ICD to incorporate our clinically proven AF Suppression(TM) technology, was introduced during the quarter and has been well received by the clinical community. We expect to follow that product in the months ahead with the launch of the Atlas(R) Plus ICD, the industry's most powerful ICD that also incorporates AF Suppression(TM). We believe that our share of the conventional ICD market continued its steady increase in the second quarter. "Our second quarter view of the ICD market saw good growth in the conventional ICD segment. We also saw expanded use of ICDs with cardiac resynchronization (CRT) capability, a new high-voltage segment which we expect to enter with several advanced products in 2004. We are very excited that the new CRT ICD market is developing strongly in the U.S., as we anticipate a very attractive St. Jude Medical product offering next year. Our progress in the RHYTHM ICD study of the Epic(TM) HF ICD with CRT capability remains on track in every respect. On March 28, we announced that minimum patient enrollment had been achieved in this study. Those patients are being followed for six months as required in the study design. We expect to submit a pre-market approval application for the Epic(TM) HF device in the fourth quarter, as previously communicated," Starks said. On June 10, St. Jude Medical announced that the first patients had been enrolled in the V-V (left ventricular, right ventricular) optimization phase of the RHYTHM study, with the expectation to provide clinical evidence that optimizing the interventricular timing of biventricular pacing therapy improves exercise capacity and left ventricular performance. The Company has also enrolled patients in the Quicksite(TM) over-the-wire (OTW) lead portion of the clinical trial. The St. Jude Medical Epic(TM) HF ICD and the Quicksite(TM) OTW lead heart lead are already approved and commercially available in Europe. Starks continued, "In our low-voltage product line, sales for the second quarter totaled $212 million, an increase of 10% over last year's second quarter. International pacing sales continued to be strong, up 32%. A global launch is underway of the first models in our new pacemaker product family, the Identity(R) ADx DR, part of the Company's Team ADx product family, incorporating unique AT/AF discrimination and diagnostic features to complement our AF Suppression(TM) technology, and significant enhancements in programmer capabilities." At the North American Society of Pacing and Electrophysiology (NASPE) meeting in May, the results of the OASES clinical trial demonstrated that St. Jude Medical's unique AF Suppression(TM) algorithm significantly reduced atrial fibrillation (AF) in patients with a history of AF and that even better results can be obtained with placement of the atrial lead in the low atrial septum. Also during the second quarter, the Company received FDA approval of the IsoFlex(R) S pacing lead and the first implant of the IsoFlex(R) P pacing lead. In the electrophysiology (EP) catheter component of the cardiac rhythm management business, sales of EP catheters were $32 million, up about 40% over last year. Second quarter sales in the Company's vascular closure business increased 36% to $52 million, compared to the second quarter of 2002 with the continued strong customer acceptance of the St. Jude Medical Angio-Seal(TM) product line. Initial launch of the Angio-Seal(TM) STS Plus is underway. The STS Plus builds on the very successful STS platform directed toward more efficient device positioning, smoother arterial access and simplified deployment. Sales of other Cardiology and Vascular access products for the quarter were $22 million. Cardiac Surgery sales for the quarter were approximately $71 million, an increase of approximately 6% over the second quarter of 2002. Heart valve sales for the quarter were approximately $65 million, an increase of approximately 6% compared to the second quarter of 2002. Starks concluded, "An important event during the second quarter was our announcement on May 2 of a minority investment in Epicor Medical, Inc., a developer of new devices for the treatment of atrial fibrillation (AF) which is the most common heart arrhythmia and a significant worldwide health challenge. The agreement with Epicor Medical also provides that St. Jude Medical will acquire Epicor Medical in 2004 if specific clinical and regulatory milestones are achieved. Epicor Medical is pursuing the clinical evaluation of its High Intensity Focused Ultrasound (HIFU) ablation system for surgical treatment of AF. Epicor Medical's technology is unique and has the potential to deal definitely and simply with patients suffering from even the most difficult forms of AF. In addition, Epicor Medical's surgical ablation system would represent a new growth opportunity for our cardiac surgery business, leverage St. Jude Medical's long-standing relationship with cardiac surgeons and expand St. Jude Medical's "Surround AF" strategy." The Company expects consolidated EPS for the third quarter to be in the range of $0.43 - $0.45 and continues to expect EPS for the full year 2003 to be in the range of $1.75 to $1.80. St. Jude Medical's conference call will be webcast live and archived on July 16, 2003, at 8 AM CDT on the following website (www.sjm.com):
http://phx.corporate-ir.net/phoenix.zhtml?c=73836&p=irol-EventDetails&EventId=750613.
Any statements made regarding the Company's anticipated product approvals, sales, expenses and earnings are forward-looking statements which are subject to risks and uncertainties, such as those described in the Financial Report section of the Company's Annual Report to Shareholders for the fiscal year ended December 31, 2002 (see pages 6-8). Actual results may differ materially from anticipated results. St. Jude Medical, Inc. (www.sjm.com) is dedicated to the design, manufacture and distribution of innovative medical devices of the highest quality, offering physicians, patients and payers unmatched clinical performance and demonstrated economic value. ST. JUDE MEDICAL, INC. CONDENSED CONSOLIDATED STATEMENTS OF EARNINGS (DATA IN THOUSANDS, EXCEPT EPS) (UNAUDITED)
Three Months Three Months Six Months Six Months Ended Ended Ended Ended June 30, 2003 June 30, 2002 June 30, 2003 June 30, 2002 Net sales $ 495,093 $ 404,348 $ 936,477 $ 775,541 Cost of sales 161,300 128,962 300,764 247,750 Gross profit 333,793 275,386 635,713 527,791 Selling, general & administrative 163,916 131,210 303,000 253,897 Research & development 60,203 49,291 116,145 95,756 Operating profit 109,674 94,885 216,568 178,138 Other income (expense) 1,045 227 2,242 (258) Earnings before taxes 110,719 95,112 218,810 177,880 Income tax provision 28,787 25,557 56,891 46,249 Net earnings $ 81,932 $ 69,555 $ 161,919 $ 131,631 Earnings per share Basic $ 0.45 $ 0.39 $ 0.90 $ 0.75 Diluted $ 0.43 $ 0.38 $ 0.86 $ 0.72 Basic shares outstanding 180,289 176,396 179,588 175,810 Diluted shares outstanding 189,119 183,472 187,723 182,929
CONDENSED CONSOLIDATED BALANCE SHEETS (DATA IN THOUSANDS) (UNAUDITED) June 30, 2003 Dec. 31, 2002 Cash & equivalents $ 589,142 $ 401,860 Accounts receivable, net 493,282 381,246 Inventories 290,732 227,024 Other current assets 141,218 104,187 Property, plant & equipment, net 302,364 300,481 Other assets 721,963 536,581 Total assets $2,538,701 $1,951,379 Short-term debt $ 31,647 $ 0 Other current liabilities 409,428 374,652 Long-term debt 176,757 0 Deferred income taxes 48,238 0 Total equity 1,872,631 1,576,727 Total liabilities & equity $2,538,701 $1,951,379 -----END PRIVACY-ENHANCED MESSAGE-----