-----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, T5V95QM750+JZBWSi0R7IpqvORCnL5v3Bo4E4fHBEVZaCf4idfX62Xlj/vfTg7bH GtwJyq9giBdLlh17fxYP5g== 0001157523-07-010970.txt : 20071108 0001157523-07-010970.hdr.sgml : 20071108 20071108073015 ACCESSION NUMBER: 0001157523-07-010970 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20071108 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20071108 DATE AS OF CHANGE: 20071108 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: 071223463 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 a5541186.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, 2007 - -------------------------------------------------------------------------------- (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 of Incorporation) Identification Number) 0-20584 (Commission File Number) 22 Cherry Hill Drive Danvers, MA 01923 (Address of Principal Executive Offices, including Zip Code) (978) 646-1400 (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, 2007 we issued a press release reporting our financial results for our fiscal quarter ended September 30, 2007. 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, 2007. 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, 2007 Exhibit Index Exhibit Number Description - ---------------- ----------------------------------------------------- 99.1 Press release dated November 8, 2007. EX-99.1 2 a5541186ex99_1.txt EXHIBIT 99.1 Exhibit 99.1 AbioMed Announces Fiscal Second Quarter 2008 Results and Reaffirms Full Year Fiscal 2008 Revenue Guidance -- Revenue up 5% to $11.4 million -- Impella 2.5 High-Risk PCI Pivotal Trial Conditionally Approved in Late Fiscal Q2 2008 -- Customer Orders of $1.6 million for Impella 2.5 Pivotal Trial and AbioCor Not Included in Fiscal Q2 Revenue -- Impella Disposable Revenue up 140% DANVERS, Mass.--(BUSINESS WIRE)--Nov. 8, 2007--Abiomed, Inc. (NASDAQ: ABMD) today announced fiscal second quarter 2008 revenue of approximately $11.4 million, up approximately 5% compared to revenue of $10.9 million for the same period of fiscal 2007. Revenue for the six months ended September 30, 2007 was approximately $25.4 million, up approximately 6% compared to revenue of approximately $23.9 million in the first six months of fiscal 2007. Recent financial and operating highlights include: -- While there are no guarantees for a 510(k) clearance, current informal FDA feedback is that the Impella(R) 2.5 is on the substantially equivalent (SE) path, and that the device does not pose any new questions as compared to the predicate devices. Abiomed is preparing responses to the FDA questions on the 510(k) submission for the Impella 2.5. -- During the second quarter of fiscal 2008 compared to the second quarter of fiscal 2007, Impella disposable revenue increased 140%, AB5000 disposable revenue increased 20%, and BVS(R) 5000 disposable revenue declined 10%. -- Impella console revenue increased 100% and AB5000(TM) console revenue decreased 48%. The Company's iPulse(TM) combination console continues to be under regulatory review by the FDA for PMA supplement approval. The Company expects FDA supplement approval for the iPulse in the third quarter of fiscal 2008, which ends December 31, 2007; however there is no guarantee that approval will be received. -- Abiomed received approval in late fiscal Q2 2008 for one of its two submissions for a pivotal study with Impella 2.5. The high-risk PCI (percutaneous coronary intervention) pivotal study approval is for the Impella 2.5 at up to 150 hospitals. -- Customer orders of $1.6 million related to both the Impella 2.5 pivotal trial and AbioCor were not included in revenue for the second quarter of fiscal 2008. Impella orders were deferred due to investigational review board (IRB) processes and training requirements. -- Abiomed is waiting for FDA approval for its Impella 2.5 acute myocardial infarction (AMI) shock pivotal trial, which is expected sometime in the quarter ending December 31, 2007; however there is no guarantee that approval will be received. -- The second quarter of fiscal 2008 GAAP net loss was $9.4 million, or $.29 per share, which included stock option and other stock-based compensation expense of $1.3 million, or $.04 per share. The net loss for the second quarter of fiscal 2007 was $8.7 million, or $.33 per share and included stock option and other stock-based compensation expense of $1.6 million, or $.06 per share. "We were pleased with the global Impella revenue growth for the summer quarter, especially in Europe. Overall, we are excited and prepared to enter the U.S. market with our strategic platforms of Impella and iPulse products when we receive FDA approvals," said Michael R. Minogue, Chairman, CEO and President of Abiomed. "We have started the Impella 2.5 pivotal trial for high-risk PCI following a very successful TCT Conference and we continue to work toward obtaining 510(k) clearance of the Impella 2.5 and approval to begin our Impella 2.5 AMI pivotal study. As we stated at the start of the fiscal year, the revenue ramp in the U.S. is dependent on regulatory approvals and would be second half loaded." Abiomed is reaffirming its full-year fiscal 2008 revenue growth estimate of greater than 20%, based on the Company's expected timing of U.S. clinical trials and global regulatory approvals of new products (Impella 2.5, iPulse supplement, and AbioCor supplement). The Company will release complete second fiscal quarter 2008 results on November 8, 2007, and host a conference call to discuss the results that day at 8:00 a.m. ET. 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 http://investor.abiomed.com or dial 866-202-4367; the international number is 617-213-8845. The access code is 59616122. A replay of this conference call will be available beginning at 10 a.m. ET on November 8, 2007 through 11:59 p.m. ET on November 22, 2007. The replay phone number is 888-286-8010; the international number is 617-801-6888. The replay access code is 15308576. ABOUT ABIOMED Based in Danvers, Massachusetts, Abiomed, Inc., is a leading provider of medical devices that provide circulatory support to acute heart failure patients across the continuum of care in heart recovery. Our products are designed to enable the heart to rest, heal and recover by improving blood flow and/or performing the pumping of the heart. 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, the expected timing of regulatory approvals on various products including iPulse and the Impella product lines, 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 for its products including iPulse and the Impella product lines, 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 risk factors included in its most recently filed annual report 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 Statements of Operations (Unaudited) (in thousands, except per share data) Three Months Ended Six Months Ended September 30, September 30, ------------------ ------------------- 2007 2006 2007 2006 --------- -------- --------- --------- Revenue: Products $11,272 $10,867 $ 25,173 $ 23,875 Funded research and development 83 19 246 19 --------- -------- --------- --------- 11,355 10,886 25,419 23,894 --------- -------- --------- --------- Costs and expenses: Cost of product revenue excluding amortization of intangibles 2,877 2,925 6,409 6,408 Research and development 5,832 5,285 11,348 10,704 Selling, general and administrative 12,257 11,046 24,699 20,438 Arbitration decision (26) --- 1,206 --- Expensed in-process research and development --- --- --- 800 Amortization of intangible assets 386 504 766 870 --------- -------- --------- --------- 21,326 19,760 44,428 39,220 --------- -------- --------- --------- Loss from operations (9,971) (8,874) (19,009) (15,326) --------- -------- --------- --------- Other income: Investment income 802 286 1,709 601 Other income, net (68) 15 (67) 159 --------- -------- --------- --------- 734 301 1,642 760 --------- -------- --------- --------- Net loss before provision for income taxes (9,237) (8,573) (17,367) (14,566) Provision for income taxes 145 103 290 241 --------- -------- --------- --------- Net loss $(9,382) $(8,676) $(17,657) $(14,807) ========= ======== ========= ========= Basic and diluted net loss per share $ (0.29) $ (0.33) $ (0.55) $ (0.56) Weighted average shares outstanding 32,422 26,611 32,379 26,553 Abiomed, Inc. and Subsidiaries Condensed Consolidated Balance Sheets (in thousands, except share data) September March 31, 30, 2007 2007 ----------------------- (Unaudited) ASSETS Current assets: Cash and cash equivalents $ 59,518 $ 69,646 Short-term marketable securities --- 5,479 Accounts receivable, net 8,615 10,932 Inventories 14,600 8,567 Prepaid expenses and other current assets 1,661 1,758 ------------ ---------- Total current assets 84,394 96,382 Property and equipment, net 7,033 5,764 Intangible assets, net 6,989 7,329 Goodwill 28,396 26,708 ------------ ---------- Total assets $ 126,812 $ 136,183 ============ ========== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 5,312 $ 5,185 Accrued expenses 6,582 7,017 Deferred revenue 774 695 ------------ ---------- Total current liabilities 12,668 12,897 Long-term deferred tax liability 2,458 1,191 Other long-term liabilities 275 --- ------------ ---------- Total liabilities 15,401 14,088 ------------ ---------- 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 325 323 Authorized - 100,000,000 shares; Issued - 32,524,030 shares at September 30, 2007 and 32,254,577 shares at March 31, 2007; Outstanding - 32,513,011 shares at September 30, 2007 and 32,243,558 shares at March 31, 2007 Additional paid-in-capital 298,248 292,467 Accumulated deficit (189,121) (171,189) Treasury stock at cost - 11,019 shares at September 30, 2007 and at March 31, 2007 (116) (116) Accumulated other comprehensive income 2,075 610 ------------ ---------- Total stockholders' equity 111,411 122,095 ------------ ---------- Total liabilities and stockholders' equity $ 126,812 $ 136,183 ============ ========== CONTACT: Abiomed, Inc. Daniel J. Sutherby, 978-777-5410 Chief Financial Officer ir@abiomed.com or Brodeur Heather Nevers, 617-587-2814 Media Relations hnevers@brodeur.com -----END PRIVACY-ENHANCED MESSAGE-----