-----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, JCVL2vjpMCdDXL5uDMU6QFJIzBwkFWZ1FCElwQWZDTxKLQQR+l/NOzocjnP2KtjZ AuTDWrkoenLFx6wNQExRIw== 0001157523-04-009443.txt : 20041019 0001157523-04-009443.hdr.sgml : 20041019 20041019165430 ACCESSION NUMBER: 0001157523-04-009443 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20041019 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20041019 DATE AS OF CHANGE: 20041019 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MEDICINES CO /DE CENTRAL INDEX KEY: 0001113481 STANDARD INDUSTRIAL CLASSIFICATION: PHARMACEUTICAL PREPARATIONS [2834] IRS NUMBER: 043324394 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-31191 FILM NUMBER: 041085816 BUSINESS ADDRESS: STREET 1: 8 CAMPUS DRIVE CITY: PARSIPPANY STATE: NJ ZIP: 07054 BUSINESS PHONE: 973-656-1616 FORMER COMPANY: FORMER CONFORMED NAME: MEDICINES CO/ MA DATE OF NAME CHANGE: 20000504 8-K 1 a4745314.txt THE MEDICINES COMPANY 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): October 19, 2004 The Medicines Company - ------------------------------------------------------------------------------- (Exact Name of Registrant as Specified in Charter) Delaware 000-31191 04-3324394 - ---------------------------------- ------------ -------------------- (State or Other Jurisdiction (Commission (IRS Employer of Incorporation) File Number) Identification No.) 8 Campus Drive Parsippany, New Jersey 07054 - ------------------------------------------------------------- ----------- (Address of Principal Executive Offices) (Zip Code) Registrant's telephone number, including area code: (973) 656-1616 - ------------------------------------------------------------------------------- (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 (see General Instruction A.2. below): |_| Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) |_| Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) |_| Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) |_| 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. On October 19, 2004, The Medicines Company (the "Company") announced its financial results for the quarter ended September 30, 2004. The full text of the press release issued in connection with the announcement is attached as Exhibit 99.1 to this Current Report on Form 8-K. The information in this Form 8-K (including Exhibit 99.1) shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 (the "Exchange Act") or otherwise subject to the liabilities of that section, nor shall it be deemed incorporated by reference in any filing under the Securities Act of 1933 or the Exchange Act, except as expressly set forth by specific reference in such a filing. Item 9.01. Financial Statements and Exhibits (c) Exhibits The following exhibit relating to Item 2.02 shall be deemed to be furnished, and not filed: 99.1 Press Release entitled "The Medicines Company Reports Third Quarter Financial Results." issued by The Medicines Company on October 19, 2004. 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. THE MEDICINES COMPANY Date: October 19, 2004 By: /s/ Steven H. Koehler --------------------- Steven H. Koehler Senior Vice President and Chief Financial Officer Exhibit Index Exhibit No. Description ----------- ----------- 99.1 Press release dated October 19, 2004 entitled "The Medicines Company Reports Third Quarter Financial Results." EX-99.1 2 a4745314ex991.txt NEWS RELEASE Exhibit 99.1 The Medicines Company Reports Third Quarter Financial Results; Third Quarter Net Revenue of $37.7 Million - up 77% Compared to 2003 Period PARSIPPANY, N.J.--(BUSINESS WIRE)--Oct. 19, 2004-- Third Quarter Earnings of $5.3 Million; Company Raises Guidance Again for 2004; Phase III Programs Expected to Deliver Results in 2004 and Early 2005 The Medicines Company (Nasdaq: MDCO) today announced its financial results for the third quarter and first nine months of 2004. Financial highlights include: -- Year-on-year revenue growth exceeds 75%. Net revenue of $37.7 million for the third quarter 2004, compared to $21.2 million for the third quarter 2003; for the first nine months of 2004, net revenue was $103.4 million, compared to $56.7 million for the first nine months of 2003. -- Sustained and growing earnings. -- Net income of $5.3 million for the third quarter 2004, compared to a net loss of $6.2 million for the third quarter 2003; for the first nine months of 2004, net income was $12.3 million, compared to a net loss of $19.2 million for the first nine months of 2003. -- Net income per share of $0.11 (diluted) for the third quarter 2004, compared to a net loss per share of $0.13 for the third quarter 2003; for the first nine months of 2004, net income per share was $0.25 (diluted), compared to a net loss per share of $0.43 for the first nine months of 2003. Clive Meanwell, Chairman, President and Chief Executive Officer of The Medicines Company stated, "Strong Angiomax(R) sales in the summer, which has historically been the lowest volume period in our market, drove our continued growth. We are increasing our 2004 revenue guidance to an anticipated $139-141 million, from $134-139 million. We are also revising our earnings guidance, from $12-19 million to $15-19 million." Operational developments in the third quarter include: -- European approval - the Company received marketing authorization for European sales of Angiomax(R) (bivalirudin) (under the tradename Angiox(TM)) for use as an anticoagulant in patients undergoing percutaneous coronary interventions. We anticipate launch in European countries during the fourth quarter. The Medicines Company recorded European pipeline stocking sales in the third quarter 2004. -- Important new published data on Angiomax(R) - JAMA publication of 1-year data from the REPLACE-2 clinical trial. The paper reported long-term efficacy of Angiomax in patients undergoing coronary angioplasty with stenting and included analyses suggesting lower mortality in high risk patients treated with Angiomax than among high risk patients treated with heparin plus GP IIb/IIIa inhibitors. -- Springboard for 4th quarter sales - a major presence at the Transcatheter Cardiovascular Therapeutics meeting in Washington during October. -- Progress with three Phase III clinical programs - continued recruitment of patients for trials of Angiomax in coronary artery bypass surgery (EVOLUTION, CHOOSE), Angiomax in acute coronary syndromes (ACUITY) and Clevelox(TM) in coronary surgery (ESCAPE). -- Progress with Cangrelor - manufacturing progress and significant steps in clinical trial protocol planning. -- New organizational structure - creation of fully integrated business units in (1) Interventional and Emergency Medicines and (2) Surgery Therapeutics to continue our concentrated and customer-oriented stance. Brent Furse, Vice President and General Manager of the Interventional and Emergency Medicines business unit, said, "Release of the 1-year REPLACE-2 data in JAMA and our experiences at TCT - where we had our strongest presence to date - strengthened our belief in the substantial growth potential of Angiomax in the cath lab in coronary angioplasty. We are delivering intensive development, marketing and sales programs in the cath lab and look forward to strong 4th quarter and 2005 results." Bob Weiland, Vice President and General Manager of the Surgery Therapeutics business unit, said, "We have made excellent progress with our surgery Phase III programs for both Clevelox and Angiomax. We are approaching the point of release of Phase III data - we expect that some data will be ready as soon as the 4th quarter 2004 - and we are planning NDA submissions and pre-launch activities for 2005." There will be a conference call with management today at 5:00 P.M. to discuss 2004 financial and operations results, as well as guidance. To listen live, webcast login is available at http://www.themedicinescompany.com. Alternatively, the call dial-in is 800-472-8325 (request The Medicines Company call). From outside U.S.: dial 1-706-679-0816. Replay available for two weeks following call: 1-800-642-1687. Replay outside the U.S.: 1-706-645-9291. Replay passcode: 1527805. The Medicines Company meets the demands of the world's most advanced medical practitioners by developing products that improve acute hospital care. The Company markets Angiomax(R) (bivalirudin), an anticoagulant approved in the U.S. and other countries for use in patients undergoing percutaneous transluminal coronary angioplasty (PTCA) procedures. The Medicines Company creates value using its range of clinical and commercial skills to develop products acquired from leading life science innovators. Statements contained in this press release about The Medicines Company, the Company's projected revenues and financial results, Angiomax, the timing of clinical trial results, and all other statements that are not purely historical, may be deemed to be forward-looking statements for purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Without limiting the foregoing, the words "believes", "anticipates", "plans", "expects", "intends", "potential", "estimates" and similar expressions are intended to identify forward-looking statements. These forward-looking statements involve known and unknown risks and uncertainties that may cause the Company's actual results, levels of activity, performance or achievements to be materially different from those expressed or implied by these forward-looking statements. Important factors that may cause or contribute to such differences include the extent of the commercial success of Angiomax, the Company's dependence on third-party distributors for sales of Angiomax or Angiox in foreign countries, physicians' acceptance of Angiomax clinical trial results, such as the results referred to above, whether the Company will be able to obtain regulatory approval for additional indications of Angiomax, whether the Company's products will receive approvals from regulatory agencies, including pricing and reimbursement approvals in certain European countries, whether the Company's products will advance in the clinical trials process, whether the clinical trial results will warrant submission of applications for regulatory approval, and such other factors as are set forth in the risk factors detailed from time to time in the Company's periodic reports and registration statements filed with the Securities and Exchange Commission including, without limitation, the risk factors detailed in the Company's Quarterly Report on Form 10-Q filed on August 6, 2004, which are incorporated herein by reference. The Company specifically disclaims any obligation to update these forward-looking statements. The Medicines Company Condensed Consolidated Statements of Operations Three months ended September 30, -------------------------------- (in thousands, except per share data) (unaudited) -------------------------------- 2004 2003 -------- -------- Net revenue $37,715 $21,248 Operating expenses: Cost of revenue 9,148 6,602 Research and development 12,332 9,383 Selling, general and administrative 11,353 11,835 -------- -------- Total operating expenses 32,833 27,820 -------- -------- Income/(loss) from operations 4,882 (6,572) Other income 516 410 -------- -------- Income/(loss) before income taxes 5,398 (6,162) Provision for income taxes (137) - -------- -------- Net income/(loss) $5,261 $(6,162) ======== ======== Basic earnings/(loss) per common share $0.11 $(0.13) ======== ======== Shares used in computing basic earnings/(loss) per common share 47,885 47,130 ======== ======== Diluted earnings/(loss) per common share $0.11 $(0.13) ======== ======== Shares used in computing diluted earnings/(loss) per common share 49,666 47,130 ======== ======== The Medicines Company Condensed Consolidated Statements of Operations Nine months ended September 30, -------------------------------- (in thousands, except per share data) (unaudited) -------------------------------- 2004 2003 -------- -------- Net revenue $103,386 $56,703 Operating expenses: Cost of revenue 20,329 19,835 Research and development 34,183 24,836 Selling, general and administrative 37,599 32,191 -------- -------- Total operating expenses 92,111 76,862 -------- -------- Income/(loss) from operations 11,275 (20,159) Other income 1,475 994 -------- -------- Income/(loss) before income taxes 12,750 (19,165) Provision for income taxes (418) - -------- -------- Net income/(loss) $12,332 $(19,165) ======== ======== Basic earnings/(loss) per common share $0.26 $(0.43) ======== ======== Shares used in computing basic earnings/(loss) per common share 47,715 45,036 ======== ======== Diluted earnings/(loss) per common share $0.25 $(0.43) ======== ======== Shares used in computing diluted earnings/(loss) per common share 49,697 45,036 ======== ======== The Medicines Company Condensed Consolidated Balance Sheets (Unaudited) September 30, December 31, (in thousands) 2004 2003 ------------- ------------ ASSETS Cash, cash equivalents, available for sales securities $136,929 $135,864 Accrued interest receivable 673 991 Accounts receivable, net 29,068 15,660 Inventories 20,356 11,460 Prepaid expenses and other current assets 1,539 976 --------- --------- Total current assets 188,565 164,951 --------- --------- Fixed assets, net 1,537 1,511 Other assets 160 200 --------- --------- Total assets $190,262 $166,662 ========= ========= LIABILITIES AND STOCKHOLDER'S EQUITY Current liabilities $27,271 $25,227 Deferred revenue 3,612 1,270 Stockholders' equity 159,379 140,165 --------- --------- Total liabilities and stockholders' equity $190,262 $166,662 ========= ========= CONTACT: The Medicines Company Michael Mitchell, 973-656-1616 investor.relations@themedco.com -----END PRIVACY-ENHANCED MESSAGE-----