-----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, R4OaXu2U4OWWXCIPtlzGLexA3QpFQvjVd9Mn7wJx3i86slXieHyW+prLi09mA3vd AuBkSJg3Cmsghc1w6uV+jQ== 0000927016-98-003120.txt : 19980817 0000927016-98-003120.hdr.sgml : 19980817 ACCESSION NUMBER: 0000927016-98-003120 CONFORMED SUBMISSION TYPE: 10-Q PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 19980630 FILED AS OF DATE: 19980814 SROS: NASD FILER: COMPANY DATA: COMPANY CONFORMED NAME: INNOVASIVE DEVICES INC CENTRAL INDEX KEY: 0001003608 STANDARD INDUSTRIAL CLASSIFICATION: ORTHOPEDIC, PROSTHETIC & SURGICAL APPLIANCES & SUPPLIES [3842] IRS NUMBER: 043132641 STATE OF INCORPORATION: MA FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 10-Q SEC ACT: SEC FILE NUMBER: 000-28492 FILM NUMBER: 98688531 BUSINESS ADDRESS: STREET 1: 734 FOREST ST CITY: MARLBOROUGH STATE: MA ZIP: 01752 BUSINESS PHONE: 5084346000 MAIL ADDRESS: STREET 1: 734 FOREST STREET CITY: MARLBOROUGH STATE: MA ZIP: 01752 10-Q 1 FORM 10-Q FORM 10-Q SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 QUARTERLY REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the Quarter ended June 30, 1998 Commission file number 0-28492 ------------- INNOVASIVE DEVICES, INC. (Exact name of registrant as specified in its charter) Massachusetts 04-3132641 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 734 Forest Street, Marlborough MA 01752 (Address of principal executive offices) Registrant's telephone number, including area code 508/460-8229 ------------ N/A Former name, former address and former fiscal year, if changed since last report. Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the preceding 12 months or for such shorter period that the registrant was required to file such reports) and (2) has been subject to such filing requirements for the past 90 days. (1) YES X NO --- --- (1) YES NO X --- --- The number of shares outstanding of the registrant's common stock as of August 12, 1998 was 9,180,386. INNOVASIVE DEVICES, INC. INDEX
Page ---- Part I: Financial Information Item 1. Condensed Consolidated Financial Statements Condensed Consolidated Balance Sheet at June 30, 1998 (unaudited) and December 31, 1997 3 Condensed Consolidated Statement of Operations (unaudited) for the Three and Six Months Ended June 30, 1998 and 1997 4 Condensed Consolidated Statement of Cash Flows (unaudited) for the Six Months Ended June 30, 1998 and 1997 5 Notes to Unaudited Condensed Consolidated Financial Statements 6 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 7 PART II. Other Information 11 Signatures 13
2 Part I - Financial Information Item 1. Financial Statements INNOVASIVE DEVICES, INC. Condensed Consolidated Balance Sheet (in thousands)
June 30, December 31, 1998 1997 ----------- ------------ (unaudited) ASSETS Current assets: Cash and cash equivalents $ 5,289 $ 2,916 Marketable securities 3,733 10,604 Accounts receivable, net of allowance for doubtful accounts of $139 and $121 at June 30, 1998 and December 31, 1997, respectively 1,889 1,625 Inventories 3,957 2,947 Prepaid expenses 31 116 -------- -------- Total current assets 14,899 18,208 Fixed assets, net 2,047 1,960 Other assets, net 1,184 1,352 -------- -------- $ 18,130 $ 21,520 ======== ======== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 675 $ 809 Accounts payable to related party 188 392 Other current liabilities 1,148 1,122 -------- -------- Total current liabilities 2,011 2,323 -------- -------- Stockholders' equity: Common stock 1 1 Additional paid-in capital 54,798 54,702 Accumulated deficit (38,600) (35,156) Deferred compensation (80) (350) -------- -------- 16,119 19,197 -------- -------- $ 18,130 $ 21,520 ======== ========
The accompanying notes are an integral part of these condensed consolidated financial statements. 3 INNOVASIVE DEVICES, INC. Condensed Consolidated Statement of Operations (In thousands, except per share data; unaudited)
Three months ended Six months ended June 30, June 30, ------------------------- ----------------------- 1998 1997 1998 1997 -------- -------- -------- -------- Net sales $ 2,955 $ 1,751 $ 5,513 $ 3,414 Cost of sales 829 510 1,544 1,020 --------- ---------- --------- --------- Gross profit 2,126 1,241 3,969 2,394 Selling, general and administrative expenses 2,749 1,856 5,471 3,351 Research and development 1,165 927 2,261 1,757 Purchased in-process research and development - 13,370 - 13,370 --------- ---------- --------- --------- Loss from operations (1,788) (14,912) (3,763) (16,084) Interest income, net 124 286 319 585 --------- ---------- --------- --------- Net loss ($ 1,664) ($ 14,626) ($ 3,444) ($ 15,499) ========= ========== ========= ========= Basic and diluted net loss per share ($ 0.18) ($ 2.00) ($ 0.38) ($ 2.12) ========= ========== ========= ========= Shares used in computing basic and diluted net loss per share 9,175 7,328 9,171 7,294 ========= ========== ========= =========
The accompanying notes are an integral part of these condensed consolidated financial statements. 4 INNOVASIVE DEVICES, INC. Condensed Consolidated Statement of Cash Flows (In thousands; unaudited)
Six months ended June 30, -------------------- 1998 1997 -------- -------- Cash flows from operating activities Net loss $(3,444) $(15,499) Adjustments to reconcile net loss to net cash provided by (used for) operating activities: Depreciation and amortization 462 170 Amortization of deferred compensation 323 21 Purchased in-process research and development - 13,370 Changes in assets and liabilities: Accounts receivable, net (264) (381) Inventories (1,010) (692) Prepaid expenses 85 (83) Other assets 110 - Accounts payable (134) 6 Accounts payable to related party (204) 173 Other current liabilities 26 (62) ------- -------- Net cash used for operating activities (4,050) (2,977) ------- -------- Cash flows from investing activities Purchases of fixed assets (490) (404) Purchases of marketable securities (5,424) (8,125) Redemption of marketable securities 12,295 3,197 Acquisition of business, net of cash acquired - (372) ------- -------- Net cash provided by (used for) investing activities 6,381 (5,704) ------- -------- Cash flows from financing activities Proceeds from issuance of common stock, net of issuance costs 42 26 ------- -------- Net increase (decrease) in cash and cash equivalents 2,373 (8,655) Cash and cash equivalents at beginning of period 2,916 12,825 ------- -------- Cash and cash equivalents at end of period $ 5,289 $ 4,170 ======= ========
The accompanying notes are an integral part of these condensed consolidated financial statements. 5 INNOVASIVE DEVICES, INC. Notes to Unaudited Condensed Consolidated Financial Statements (IN THOUSANDS, EXCEPT SHARE AND PER SHARE DATA) 1. BASIS OF PRESENTATION The accompanying unaudited condensed consolidated financial statements of Innovasive Devices, Inc. (the "Company") include, in the opinion of management, all adjustments (consisting of normal recurring adjustments) considered necessary for a fair presentation of the Company's financial position as of June 30, 1998 and the results of operations for the three and six month periods ended June 30, 1998 and 1997. Results of operations for interim periods are not necessarily indicative of those to be achieved for the full year. Pursuant to accounting requirements of the Securities and Exchange Commission (the "SEC") applicable to quarterly reports on Form 10-Q, the accompanying unaudited condensed consolidated financial statements and these notes do not include all disclosures required by generally accepted accounting principles for complete financial statements. Accordingly, these statements should be read in conjunction with the financial statements and accompanying notes contained in the Company's Annual Report on Form 10-K for the year ended December 31, 1997 filed with the SEC on March 31, 1998. 2. INVENTORIES Inventories consist of the following:
June 30, December 31, 1998 1997 ------------ ------------ (unaudited) Raw materials $1,367 $1,360 Work-in-process 525 329 Finished goods 2,065 1,258 ------ ------ Totals $3,957 $2,947 ====== ======
3. NET LOSS PER SHARE (UNAUDITED) Basic earnings per share is computed by dividing the income available to common stockholders by the weighted average number of common shares outstanding for the period. For purposes of calculating diluted earnings per share, the denominator includes both the weighted average number of common shares outstanding and potential dilutive common shares outstanding for the period. For each of the periods presented, basic and diluted earnings per share are the same due to the antidilutive effect of potential common shares outstanding. 6 INNOVASIVE DEVICES, INC. Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations OVERVIEW Innovasive Devices, Inc. (the "Company") is primarily engaged in the development, manufacture and marketing of proprietary devices and instrumentation which facilitate the reattachment of soft tissue structures, such as ligaments and tendons, to bones and other tissues. The Company has a limited operating history and has expended significant resources to fund research and development, the establishment of its manufacturing capabilities and the expansion of its marketing and sales organization. The Company plans to continue investing aggressively in these areas. Although the Company's sales have been principally derived from the sale of its family of shoulder related products, the Company now markets four product platforms: suture fasteners, suture systems, cartilage repair products and anterior cruciate ligament ("ACL") reconstruction products. The Company broadened its product portfolio with the June 27, 1997 acquisition of MedicineLodge, Inc. ("MLI"), a company which designs develops and manufactures orthopaedic medical devices - particularly implants and related instrumentation used in minimally invasive arthroscopic procedures to repair injuries to the knee. The following information should be read in conjunction with the unaudited condensed consolidated financial statements and notes thereto included in this Quarterly Report and with the Financial Statements and Management's Discussion and Analysis of Financial Condition and Results of Operations contained in the Company's Annual Report on Form 10-K filed with the SEC on March 31, 1998. Any statements in this report expressing the beliefs and expectations of management regarding the Company's future results and performance are forward- looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are based on current expectations that involve a number of risks and uncertainties. The Company wishes to caution readers not to place undue reliance on any such forward- looking statements, which speak only as of the date made. Such forward looking statements are subject to certain risks and uncertainties that could cause actual results to differ materially from historical earnings and those presently anticipated or projected. These risks include the receipt of regulatory approvals, progress of product development programs, clinical efficacy of and market demand for the products. Certain of such risks and uncertainties are described in Exhibit 99 of the Company's Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 31, 1998. 7 RESULTS OF OPERATIONS THREE MONTHS ENDED JUNE 30, 1998 COMPARED TO THE THREE MONTHS ENDED JUNE 30, 1997 Net sales for the second quarter of 1997 of $2,955,000 increased $1,204,000 from $1,751,000 for the same period in the prior year. The increase resulted primarily from a higher level of sales of ROC suture anchors, suture systems and ACL reconstruction products which were not available in the second quarter of 1997. Contributing to the increase in ROC suture anchor sales was the BioROC, a bioabsorbable suture anchor introduced in the first quarter of 1998. Contributing to the increase in ACL reconstruction products was the Linx HT, a device introduced in the third quarter of 1997 which utilizes the fixation of hamstring tendon grafts in ACL repair procedures. In the second quarter of 1998 the Company commenced shipments of a new suture system product, the Y-Knot, a device used in place of traditional knot configurations when securing soft tissue to bone. Domestic net sales increased during the second quarter of 1998 over the second quarter of 1997 as a result of an increase in sales of the Company's ROC suture anchors, suture systems and ACL reconstruction products. In addition, the Company has increased its domestic direct sales force, clinical support and agent distribution network over the same quarter in the prior year. International net sales increased during the second quarter of 1998 from the second quarter of 1997 primarily as a result of an increase in ROC suture anchors and ACL reconstruction systems. Gross profit increased to $2,126,000 in the second quarter of 1998 from $1,241,000 in the second quarter of 1997. As a percentage of sales, gross profit increased to 72.0% in the second quarter of 1998 from 70.9% in the second quarter of 1997. The increase in gross profit was due primarily to an improved product sales mix in the period and higher sales volumes which resulted in improved manufacturing efficiencies. Selling, general and administrative expenses increased to $2,749,000 in the second quarter of 1998 from $1,856,000 in the second quarter of 1997. The increase resulted primarily from higher selling commissions resulting from higher sales volume, increased advertising costs relating to new product introductions, increased salary and travel costs related to the expansion of the domestic direct sales force and incremental administrative costs related to the operations of MLI, acquired in the second quarter of 1997. Research and development expenses increased to $1,165,000 in the second quarter of 1998 from $927,000 in the second quarter of 1997. The increase was primarily attributable to incremental research and development costs associated with the operations of MLI, acquired in the second quarter of 1997, and compensation related to the grant of stock options. As a result of the Company's transaction with MLI in the second quarter of 1997, the Company incurred a non recurring charge to operations of $13,370,000 representing the portion of the purchase price allocated to in-process research and development. Interest income decreased to $124,000 in the second quarter of 1998 from $286,000 in the second quarter of 1997 primarily as a result of investment returns earned on lower average cash balances maintained during the first quarter of 1998 compared to the prior year. As a result of the foregoing, the net loss decreased to $1,664,000 in the second of 1998 from a loss of $14,626,000 in the second of 1997. 8 SIX MONTHS ENDED JUNE 30, 1997 COMPARED TO SIX MONTHS ENDED JUNE 30, 1996 Net sales for the first six months of 1998 of $5,513,000 increased $2,099,000 from $3,414,000 for the same period in the prior year. The increase resulted primarily from a higher level sales of ROC suture anchors, suture systems and ACL reconstruction products which were not available in the first half of 1997. Contributing to the increase in ROC suture anchor sales was the BioROC, a bioabsorbable suture anchor introduced in the first quarter of 1998. Suture system sales also increased over the first half of 1997 partially as a result of sales of the CuffLink which was introduced in the second quarter of 1997. The CuffLink is used to augment tunnels made in the bone for rotator cuff repair procedures. Contributing to the increase in ACL reconstruction products was the Linx HT, a device introduced in the third quarter of 1997 which utilizes the fixation of hamstring tendon grafts in ACL repair procedures. Domestic net sales increased during the first half of 1998 over the first half of 1997 as a result of an increase in sales of the Company's ROC suture anchors, suture systems and ACL reconstruction products. In addition, the Company has increased its domestic direct sales force, clinical support and agent distribution network over the same period in the prior year. International net sales also increased during the first half of 1998 over the first half of 1997 primarily as a result of an increase in ROC suture anchors and ACL reconstruction systems. In the first quarter of 1998, the Company announced the appointment of Protek GmbH, a division of Sulzer Orthopaedics, and Stryker Canada, Inc. as distributors for the Company's products in Germany and Canada, respectively Gross profit increased to $3,969,000 for the first six months of 1998 from $2,394,000 for the first six months of 1997. As a percentage of sales, gross profit increased to 72.0% for the first six months of 1998 from 70.1% for the first six months of 1997. The increase in gross profit was due primarily to an improved product sales mix in the period and higher sales volumes which resulted in improved manufacturing efficiencies. Selling, general and administrative expenses increased to $5,471,000 for the first six months of 1998 from $3,351,000 for the first six months of 1997. The increase resulted primarily from the expansion of the domestic direct sales force and clinical support resulting in increased salary and travel costs, higher selling commissions resulting from the increased sales volume, increased advertising costs relating to new product introductions and incremental administrative costs related to the operations of MLI, acquired in the second quarter of 1997. Research and development expenses increased to $2,261,000 in the first half of 1998 from $1,757,000 in the first half of 1997. The increase was primarily attributable to incremental research and development costs associated with the operations of MLI, acquired in the second quarter of 1997, and compensation related to the grant of stock options. As a result of the Company's transaction with MLI in the second quarter of 1997, the Company incurred a non recurring charge to operations of $13,370,000 representing the portion of the purchase price allocated to in-process research and development. Interest income decreased to $319,000 in the first half of 1998 from $585,000 in the first half of 1997 primarily as a result of investment returns earned on lower average cash balances maintained during the first half of 1998 compared to the prior year. As a result of the foregoing, the net loss decreased to $3,444,000 in the first half of 1998 from a loss of $15,499,000 in the first half of 1997. 9 LIQUIDITY AND CAPITAL RESOURCES As of June 30, 1998, working capital amounted to $12.9 million as compared to $15.9 million at December 31, 1997. Cash used in the Company's operations amounted to $4.1 million for the first half of 1998 compared to $3.0 in the first half of 1997. The net loss incurred of $3.4 million and an increase in inventories of $1.0 were partially offset by depreciation and the amortization of deferred compensation charges. Cash provided by investing activities totaled $6.4 million for the first half of 1998 resulting from net redemptions of marketable securities totaling $6.9 million partially offset by capital equipment expenditures totaling $490,000. The Company invests its excess cash in marketable securities with maturities of less than two years. Cash provided by financing activities totaled $42,000 for the first half of 1998 resulting primarily from the exercise of common stock options. The Company expects that its balance of cash, cash equivalents and marketable securities will be adequate to fund the near term cash requirements for operations, working capital and fixed assets. The Company's future liquidity and capital requirements will depend upon the establishment of effective sales channels in the United States and abroad, the extent to which the Company's products gain market acceptance, the progress of research and development programs, regulatory requirements and the expansion of its manufacturing capabilities to satisfy increasing volume requirements. Therefore, the Company cannot provide assurances that it will not require additional financing in the future. If additional financing is necessary, the Company would seek to raise these funds through bank facilities or debt or equity offerings. There can be no assurance that such financing would be successfully completed or that such financing would be available on terms acceptable to the Company. 10 INNOVASIVE DEVICES, INC. PART II -- OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS ----------------- None ITEM 2. CHANGES IN SECURITIES ---------------------- None Item 3. Defaults Upon Senior Securities ------------------------------- None Item 4. Submission of Matters to a Vote of Security Holders --------------------------------------------------- The Company's Annual and Special Meeting of Stockholders was held on June 8, 1998 in Boston, Massachusetts. All matters submitted to a vote of the Company's stockholders were described in the Company's Proxy Statement dated May 8, 1998. At the meeting, the shareholders: (1) elected the following directors for terms expiring in 2001:
Term Total Vote For Total Vote Withheld Expires Each Director From Each Director --------- --------------- ------------------- Joseph A. Ciffolillo 2001 6,350,104 5,600 David J. Foster 2001 6,350,104 5,600
(2) approved the Company's 1996 Omnibus Stock Plan as amended by the Board of Directors; For 3,587,536 Against 327,695 Abstain 616,255 Broker Non-Votes 1,824,218 (3) ratified the Board of Directors' selection of PricewaterhouseCoopers LLP as the Company's independent auditors for the fiscal year ending December 31, 1998. For 6,352,504 Against 1,500 Abstain 1,700 11 ITEM 5. OTHER INFORMATION ----------------- None ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K --------------------------------- None 12 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. INNOVASIVE DEVICES, INC, Date: August 14, 1998 By: /s/ Richard D. Randall --------------------------------------- Richard D. Randall President, Chief Executive Officer and Director (Principal Executive Officer) Date: August 14, 1998 By: /s/ James V. Barrile -------------------------------------- James V. Barrile Executive Vice President of Finance, Chief Financial Officer and Treasurer (Principal Financial Officer) 13 EX-27 2 FINANCIAL DATA SCHEDULE
5 1,000 6-MOS DEC-31-1998 JAN-01-1998 JUN-30-1998 5,289 3,733 2,010 121 3,957 14,899 3,584 1,537 18,130 2,011 0 0 0 1 16,119 18,130 5,513 5,513 1,544 1,544 0 0 0 (3,444) 0 (3,444) 0 0 0 (3,444) (0.38) (0.38)
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