-----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, Bl0c7VKgrXgwWBNUppZr2ZlkakgDcFnHJCeBi2UNkmRm2abQF+w1zvCWoL9q6E7r E/dG+fPbiRLJHhKpSM+Gxw== 0001157523-06-011061.txt : 20061108 0001157523-06-011061.hdr.sgml : 20061108 20061108161912 ACCESSION NUMBER: 0001157523-06-011061 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20061108 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20061108 DATE AS OF CHANGE: 20061108 FILER: COMPANY DATA: COMPANY CONFORMED NAME: ABIOMED INC CENTRAL INDEX KEY: 0000815094 STANDARD INDUSTRIAL CLASSIFICATION: SURGICAL & MEDICAL INSTRUMENTS & APPARATUS [3841] IRS NUMBER: 042743260 STATE OF INCORPORATION: DE FISCAL YEAR END: 0331 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-09585 FILM NUMBER: 061197710 BUSINESS ADDRESS: STREET 1: 22 CHERRY HILL DR CITY: DANVERS STATE: MA ZIP: 01923 BUSINESS PHONE: 9787775410 MAIL ADDRESS: STREET 1: 22 CHERRY HILL DRIVE CITY: DANVERS STATE: MA ZIP: 01923 8-K 1 a5269893.txt ABIOMED, INC. 8-K 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: November 8, 2006 - -------------------------------------------------------------------------------- (Date of earliest event reported) ABIOMED, Inc. - -------------------------------------------------------------------------------- (Exact name of registrant as specified in its charter) Delaware 04-2743260 (State or other Jurisdiction (IRS Employer Identification Number) of Incorporation) 0-20584 (Commission File Number) 22 Cherry Hill Drive Danvers, MA 01923 (Address of Principal Executive Offices, including Zip Code) (978) 777-5410 (Registrant's Telephone Number, including Area Code) Not Applicable (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: |_| 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 November 8, 2006 we issued a press release reporting our financial results for our fiscal quarter ended September 30, 2006. A copy of the press release is set forth as exhibit 99.1 and is incorporated herein by reference. The information contained in this report shall not be deemed "filed" for purposes of Section 18 of the Securities Exchange Act of 1934 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 Securities Act of 1934, whether made before or after the date hereof and regardless of any general incorporation language in such filing, except as expressly set forth by specific reference in such filing. Item 9.01 Financial Statements and Exhibits. (d) Exhibits. Exhibit Description - ---------- ------------------------------------------------------------------- 99.1 Press release dated November 8, 2006. ================================================================================ 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 thereunto duly authorized. Abiomed, Inc. By: /s/ Daniel J. Sutherby ----------------------------- Daniel J. Sutherby Chief Financial Officer Date: November 8, 2006 ================================================================================ Exhibit Index Exhibit Number Description - ---------------- --------------------------------------------------------- 99.1 Press release dated November 8, 2006. EX-99.1 2 a5269893-ex991.txt EXHIBIT 99.1 EXHIBIT 99.1 Abiomed Announces Fiscal Second Quarter 2007 Results DANVERS, Mass.--(BUSINESS WIRE)--Nov. 8, 2006--Abiomed, Inc. (NASDAQ: ABMD) today announced revenue of $10.9 million for its second fiscal quarter ended September 30, 2006. Revenue for the first six months of fiscal 2007 was $23.9 million, up approximately 23% compared to revenue of $19.4 million in the first six months of fiscal 2006. Comparing the second fiscal quarter of 2007 revenue of $10.9 million to the second fiscal quarter of 2006 revenue of $10.9 million, AB5000 grew 31%, and BVS decreased approximately 37%. While not a significant contribution to total revenue for the second fiscal quarter of 2007, revenues from Impella increased 75% compared to the same period of fiscal 2006. Recent operating highlights and financial results for the second fiscal quarter of 2007 as compared to the second fiscal quarter of 2006 included: -- The Company's AbioCor(R) Implantable Replacement Heart received approval from the U.S. Food and Drug Administration under a Humanitarian Device Exemption (HDE). -- Revenue from console sales (AB5000 and Impella) grew 85%. -- The highest number of patients placed on AB5000 Circulatory Support worldwide. -- Commencement of the Impella 2.5 pilot study in the United States. -- Gross margin for the second fiscal quarter of 2007 was 73%. -- The second fiscal quarter of 2007 reported net loss was $8.7 million, or $.33 per share. The net loss for the second fiscal quarter of 2007 included stock option expense of approximately $1.6 million, or $.06 per share. "We are focused on executing our strategic goals and made progress this quarter on expanding our product portfolio with regulatory approvals and growing our global distribution," said Michael R. Minogue, Chairman, CEO and President of Abiomed. Financial information for the second quarter of fiscal 2007 is attached to this press release. CONFERENCE CALL AND WEBCAST The Company will host a conference call at 4:30 p.m. ET on November 8, 2006. Michael R. Minogue, Chairman, Chief Executive Officer and President, and Daniel J. Sutherby, Chief Financial Officer, will host the conference call. To listen to the call live, please tune into the webcast via www.abiomed.com/investors or dial 800-659-2056; the international number is 617-614-2714. The conference call passcode is 99611049. A replay of this conference call will be available beginning at 6:30 p.m ET on November 8, 2006, through 6:30 p.m. ET on November 15, 2006. The replay phone number is 888-286-8010; the international number is 617-801-6888. The replay access code is 60928364. ABOUT ABIOMED Based in Danvers, Massachusetts, Abiomed, Inc., is a leading developer, manufacturer and marketer of medical products designed to assist or replace the pumping function of the failing heart. Abiomed currently manufactures and sells the AB5000(TM) Circulatory Support System and the BVS(R) 5000 Biventricular Support System for the temporary support of all patients with failing but potentially recoverable hearts. In Europe, Abiomed offers the minimally invasive Impella(R) Circulatory Support Systems under CE Mark approval. The Impella(R) 5.0 and 2.5 are investigational devices limited by Federal Law solely to investigational use in the United States. Other Impella devices are not yet available for sale in the United States. The Company's AbioCor(R) Implantable Replacement Heart is now available under a Humanitarian Device Exemption granted by the United States Food and Drug Administration. For additional information please visit: www.abiomed.com. FORWARD-LOOKING STATEMENTS This Release contains forward-looking statements, including statements regarding development of Abiomed's existing and new products, the Company's progress toward commercial growth, and future opportunities. The Company's actual results may differ materially from those anticipated in these forward-looking statements based upon a number of factors, including uncertainties associated with development, testing and related regulatory approvals, anticipated future losses, complex manufacturing, high quality requirements, dependence on limited sources of supply, competition, technological change, government regulation, future capital needs and uncertainty of additional financing, and other risks and challenges detailed in the Company's filings with the Securities and Exchange Commission, including the Annual Report filed on Form 10-K. Readers are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this Release. The Company undertakes no obligation to publicly release the results of any revisions to these forward-looking statements that may be made to reflect events or circumstances that occur after the date of this Release or to reflect the occurrence of unanticipated events. ABIOMED, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED BALANCE SHEETS (Unaudited) (in thousands, except share data) - ---------------------------------------------------------------------- September 30, March 31, 2006 2006 ------------- ------------- ASSETS Current assets: Cash and cash equivalents $ 7,052 $ 7,832 Short-term marketable securities 14,931 23,003 Accounts receivable, net 8,300 8,880 Inventories 5,590 4,868 Prepaid expenses and other current assets 2,071 1,860 ------------- ------------- Total current assets 37,944 46,443 Property and equipment, net 5,492 4,824 Intangible assets, net 7,674 8,164 Goodwill 19,969 19,106 ------------- ------------- Total assets $71,079 $78,537 ------------- ------------- LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 3,512 $ 3,070 Accrued expenses 5,374 5,185 Deferred revenue 666 484 ------------- ------------- Total current liabilities 9,552 8,739 Long-term deferred tax 550 310 ------------- ------------- Total liabilities 10,102 9,049 ------------- ------------- Commitments and contingencies -- -- Stockholders' equity Class B Preferred Stock, $.01 par value- authorized 1,000,000 shares; issued and outstanding-none -- -- Common stock, $.01 par value 267 265 Authorized - 100,000,000 shares; Issued - 26,708,893 shares at September 30, 2006 and 26,474,270 shares at March 31, 2006; Outstanding - 26,702,714 shares at September 30, 2006 and 26,468,091 shares at March 31, 2006 Additional paid-in-capital 219,502 214,666 Deferred stock-based compensation -- (171) Accumulated deficit (158,115) (143,308) Treasury stock at cost; 6,179 shares at September 30, 2006 and March 31, 2006 (66) (66) Accumulated other comprehensive loss (611) (1,898) ------------- ------------- Total stockholders' equity 60,977 69,488 ------------- ------------- Total liabilities and stockholders' equity $71,079 $78,537 ============= ============= ABIOMED, INC. AND SUBSIDIARIES CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (Unaudited) (in thousands, except per share data) - ---------------------------------------------------------------------- Three months ended Six months ended September 30, September 30, ------------------ ------------------ 2006 2005 2006 2005 (Fiscal (Fiscal Q2 '07) Q2 '06) Revenue: Products $10,867 $10,758 $23,875 $19,158 Funded research and development 19 178 19 201 ------------------ ------------------ 10,886 10,936 23,894 19,359 Cost of product revenue and operating expenses: Cost of product revenue excluding amortization 2,925 2,448 6,408 4,781 Research and development 5,285 4,327 10,704 8,291 Selling, general and administrative 11,046 6,844 20,438 14,147 Expensed in-process research and development -- -- 800 13,306 Amortization of intangible assets 504 356 870 607 ------------------ ------------------ 19,760 13,975 39,220 41,132 ------------------ ------------------ Loss from operations (8,874) (3,039) (15,326) (21,773) ------------------ ------------------ Other income: Investment income 286 296 601 560 Foreign exchange gain (loss) (27) (58) 87 (112) Other income, net 42 22 72 38 ------------------ ------------------ 301 260 760 486 ------------------ ------------------ Net loss before provision for income taxes (8,573) (2,779) (14,566) (21,287) ------------------ ------------------ Provision for income taxes 103 -- 241 -- ------------------ ------------------ Net loss $(8,676) $(2,779) $(14,807)$(21,287) ================== ================== Basic and diluted loss per share $(0.33) $(0.11) $(0.56) $(0.85) Weighted average shares outstanding 26,611 26,251 26,553 25,056 CONTACT: Abiomed, Inc. Daniel J. Sutherby, 978-646-1812 Chief Financial Officer ir@abiomed.com or Liza Heapes, 978-646-1668 Media Relations mediarelations@abiomed.com -----END PRIVACY-ENHANCED MESSAGE-----