-----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, SinMciVETreN0P+y269ZxAUt2zCBHu+0NPI0O7A8cHd70TwnXeVaYEr3DAuT7UGv /jG1OU0nEqju5D3xKTSAfw== /in/edgar/work/0001005477-00-007106/0001005477-00-007106.txt : 20001018 0001005477-00-007106.hdr.sgml : 20001018 ACCESSION NUMBER: 0001005477-00-007106 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20001016 ITEM INFORMATION: ITEM INFORMATION: FILED AS OF DATE: 20001017 FILER: COMPANY DATA: COMPANY CONFORMED NAME: NOVOSTE CORP /FL/ CENTRAL INDEX KEY: 0001012131 STANDARD INDUSTRIAL CLASSIFICATION: [3845 ] IRS NUMBER: 592787476 STATE OF INCORPORATION: FL FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: SEC FILE NUMBER: 000-20727 FILM NUMBER: 741389 BUSINESS ADDRESS: STREET 1: 3890 STEVE REYNOLDS BLVD CITY: NORCROSS STATE: GA ZIP: 30093 BUSINESS PHONE: 7707170904 MAIL ADDRESS: STREET 1: 4350 C INTERNATIONAL BLVD CITY: NORCROSS STATE: GA ZIP: 30093 8-K 1 0001.txt FORM 8-K 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 16, 2000 ---------------- NOVOSTE CORPORATION (Exact name of registrant as specified in its charter) ------------------------------------------------------ Florida 0-20727 59-2787476 - -------------------------------------------------------------------------------- (State or other jurisdiction (Commission (IRS Employer of incorporation) File Number) Identification) 3890 Steve Reynolds Blvd., Norcross, GA 30093 ----------------------------------------------------- (Address of principal executive offices) (Zip Code) Registrant's telephone number, including area code (770) 717-0904 -------------- (Former name or former address, if changed since last report) Item 5. Other Events On October 16, 2000, the Registrant issued a press release announcing that it has received a letter from the U.S. Food and Drug Administration (FDA) stating that the Registrant's Beta-Cath(TM) System is approvable. The Beta-Cath(TM) System is an intracoronary radiation catheter system designed to treat patients suffering from in-stent restenosis. Issuance of an approvable letter means that the FDA has reviewed the Registrant's premarket approval (PMA) application, as well as its own Advisory Committee's report and recommendation, and that the FDA is prepared to approve the application, pending the Registrant's compliance with specific final conditions. A copy of the press release is attached as Exhibit 99.1 and incorporated by reference herein. The Registrant also announced that it intends to present interim results of the START 40 Trial at the Transcatheter Cardiovascular Therapeutics (TCT) meeting to be held later this week in Washington, D.C. The Registrant also intends to announce the final results of the START 40 Trial at the American Heart Association meeting in November 2000, and the results of the Beta-Cath(TM) System Trial during the first quarter of 2001. The exact timing of the announcements of such results will depend upon the completion of clinical trial data analyses. On October 17, 2000, the Registrant issued a press release announcing the third quarter 2000 financial results. A copy of the press release is attached as Exhibit 99.2 and incorporated by reference herein. Item 7. Financial Statements, Pro Forma Financial Information and Exhibits. Exhibit 99.1 Press Release dated October 16, 2000. Exhibit 99.2 Press Release dated October 17, 2000. 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, 2000 NOVOSTE CORPORATION ------------------- (Registrant) By: /s/ Edwin Cordell ----------------- Edwin Cordell Chief Financial Officer EX-99.1 2 0002.txt PRESS RELEASE DATED OCTOBER 16, 2000 Exhibit 99.1 FOR IMMEDIATE RELEASE Contact: Cheryl R. Johnson Vice President, Investor Relations NOVOSTE CORPORATION (770) 717-6052 NOVOSTE RECEIVES APPROVABLE LETTER FROM FDA FOR ITS BETA-CATH(TM) SYSTEM NORCROSS, GA., October 16, 2000 - Novoste Corporation (Nasdaq: NOVT) announced today that it has received a letter from the U.S. Food and Drug Administration (FDA) stating that the Company's Beta-Cath(TM) System is approvable. The Beta-Cath(TM) System is an intracoronary radiation catheter system designed to treat patients suffering from in-stent restenosis, a recurrent coronary artery blockage within a previously placed stent. This letter comes less than 180 days after Novoste's submission of its premarket approval application in April. Issuance of an approvable letter means that the FDA has reviewed the Company's premarket approval (PMA) application, as well as its own Advisory Committee's report and recommendation, and that the FDA is prepared to approve the application, pending Novoste's compliance with specific final conditions. The key conditions to approval of Novoste's application are successful conclusion of a Good Manufacturing Practices audit, which is nearing completion, and finalizing printed labeling materials. Other conditions relate to finalizing protocols for post-market surveillance and user training, and responding to other information requests. The FDA's Circulatory System Devices Panel of the Medical Devices Advisory Committee unanimously recommended approval of the Beta-Cath(TM) System on September 11, 2000. William A. Hawkins, President & CEO of Novoste, commented, "We have been impressed by the FDA's rapid and thorough review of our premarket approval application. We are making good progress towards resolving the FDA's conditions, and expect to have final approval of our device in the near future - perhaps in time for the American Heart Association meeting in mid-November." Novoste Corporation, based in Atlanta, Ga., is a leader in the emerging field of vascular brachytherapy to reduce the incidence of restenosis. The company's Beta-Cath(TM) System is commercially available in the European Union and other countries outside the U.S. For more information on the Beta-Cath(TM) System or Novoste, please call (770) 717-0904 or visit the company's web site at www.novoste.com. The forward-looking statements included in this news release reflect management's best judgment based on factors currently known. Actual results may differ materially from those projected in these forward-looking statements based upon risks and uncertainties, including the demonstration of safety and efficacy of the Beta-Cath(TM) System, receipt and timing of FDA and other regulatory approvals, and other risks detailed in documents filed by Novoste with the SEC including its S-3 registration statement and Forms 10-K, 10-Q and 8-K. Further, there can be no assurance that this approvable letter will result in approval from the FDA for the Beta-Cath(TM) System. # # # EX-99.2 3 0003.txt PRESS RELEASE DATED OCTOBER 17, 2000 Exhibit 99.2 FOR IMMEDIATE RELEASE Contact: Cheryl R. Johnson Edwin B. Cordell Vice President, Investor Relations Chief Financial Officer NOVOSTE CORPORATION NOVOSTE CORPORATION (770) 717-6052 (770) 717-6053 Novoste Reports Third Quarter 2000 Financial Results NORCROSS, GA., October 17, 2000 - Novoste Corporation (Nasdaq: NOVT) today announced that for the quarter ended September 30, 2000, net sales reached a record $1,446,000, a 155% increase over net sales of $567,000 in the third quarter of 1999. For the nine months ended September 30, 2000, net sales totaled $3,584,000, compared to $1,205,000 during the first nine months of 1999. The increase in net sales was due to growing catheter utilization in certain key markets, such as Germany, and continued geographic expansion of sales. Additionally, these revenues reflect the implementation of SEC Staff Accounting Bulletin (SAB) 101 effective January 1, 2000, which clarifies the requirements for recognition of certain site installation revenues. For the three months ended September 30, 2000, the Company reported a net loss of $8,705,000, or $(0.54) per share, compared to a net loss of $8,066,000, or $(0.57) per share, for the same period last year. For the nine months ended September 30, 2000, the net loss was $23,033,000, or $(1.50) per share, compared to a net loss of $23,567,000 or $(1.79) per share for the corresponding period in 1999. The increase in net loss for the quarter was attributable to higher operating expenses associated with preparation for U.S. market launch of the Beta-Cath(TM) System and with expanding international sales coverage. The slight decrease in net loss for the nine-month period was due to lower clinical trial expenses in 2000 compared to 1999. The cumulative effect of the implementation of SAB 101 on the Company's net income was insignificant. As of September 30, 2000, Novoste had $71 million in cash and cash equivalents to fund its operations. William A. Hawkins, President & CEO of Novoste, remarked, "We were pleased to report record revenues this quarter, especially in light of the weakened euro and summer holidays in Europe. As expected, Novoste's net loss increased this period as we began building our U.S. sales force in anticipation of domestic market launch of the Beta-Cath(TM) System. With the recent receipt of the approvable letter from the FDA, this launch is likely to occur prior to our previous expectations." Issuance of an approvable letter means that the FDA has reviewed the Company's premarket approval application, as well as its own Advisory Committee's report and recommendation, and that the FDA is prepared to approve the application, pending Novoste's compliance with specific final conditions. Mr. Hawkins commented further, "Later this week, Novoste will have a major presence at the Transcatheter Cardiovascular Therapeutics (TCT) meeting in Washington, D.C. We plan on announcing interim results of the START 40 Trial during the conference, as well as hosting several symposia dedicated to vascular brachytherapy." The Company will host a conference call at 10:00 a.m. Eastern on Tuesday, October 17, 2000, to discuss the third quarter results. You may access the conference call on the Internet at either: 1) novoste.com (in the "Investor/Media" section), or 2) streetevents.com. The RealPlayer 7 software is required to listen to the audio stream; a link to the Real Networks Web site is provided on the sites mentioned above to download the free software. Novoste Corporation, based in Atlanta, Ga., is a leader in the emerging field of vascular brachytherapy to reduce the incidence of restenosis. The company's Beta-Cath(TM) System is commercially available in the European Union and other countries outside the U.S. For more information on the Beta-Cath(TM) System or Novoste, please call (770) 717-0904 or visit the company's web site at www.novoste.com. The forward-looking statements included in this news release reflect management's best judgment based on factors currently known. Actual results may differ materially from those projected in these forward-looking statements based upon risks and uncertainties, including the demonstration of safety and efficacy of the Beta-Cath(TM) System, receipt and timing of FDA and other regulatory approvals, and other risks detailed in documents filed by Novoste with the SEC including its S-3 registration statement and Forms 10-K, 10-Q and 8-K. - FINANCIAL HIGHLIGHTS TO FOLLOW - NOVOSTE CORPORATION CONDENSED STATEMENT OF OPERATIONS (unaudited)
Three Months Ended September 30, Nine Months Ended September 30, 2000 1999 2000 1999 ------------ ------------ ------------ ------------ Net Revenue (1) $ 1,445,527 $ 566,872 $ 3,583,575 $ 1,204,699 Cost of Sales 977,146 539,777 2,594,894 1,216,943 ------------ ------------ ------------ ------------ Gross Margin 468,381 27,095 988,681 (12,244) ------------ ------------ ------------ ------------ Operating expenses Research and development 5,248,267 6,115,556 13,974,188 17,950,943 Sales and marketing 3,171,584 1,678,437 8,528,790 4,519,703 General and administrative 1,855,862 917,379 4,271,017 2,731,284 ------------ ------------ ------------ ------------ Total operating expenses 10,275,713 8,711,372 26,773,995 25,201,930 ------------ ------------ ------------ ------------ Loss from operations (9,807,332) (8,684,277) (25,785,314) (25,214,174) Interest income 1,102,550 618,007 2,752,457 1,647,630 ------------ ------------ ------------ ------------ Net loss $ (8,704,782) $ (8,066,270) $(23,032,857) $(23,566,544) ============ ============ ============ ============ Net loss per share $ (0.54) $ (0.57) $ (1.50) $ (1.79) ============ ============ ============ ============ Shares used in computing net loss per share 16,005,921 14,134,862 15,382,341 13,170,928 ============ ============ ============ ============
CONDENSED BALANCE SHEETS (unaudited)
September 30, December 31, 2000 1999 ------------- ------------ ASSETS Current assets Cash, cash equivalents and short-term investments $70,927,361 $41,423,692 Other current assets 3,960,684 2,968,873 ----------- ----------- Total current assets 74,888,045 44,392,565 Other assets 9,489,821 4,974,837 ----------- ----------- Total assets $84,377,866 $49,367,402 =========== =========== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities $ 7,894,214 6,302,558 Stockholders' equity 76,483,652 43,064,844 ----------- ----------- Total liabilities and stockholders' equity $84,377,866 $49,367,402 =========== ===========
(1) The impact of SAB 101 on Net Revenue for the three months ended September 30, 2000 was insignificant. The impact on Net Revenue for the nine months ended September 30, 2000 was an increase of $238,110. # # # -----END PRIVACY-ENHANCED MESSAGE-----