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Biopsys Medical Inc – ‘10-Q’ for 12/31/96

As of:  Wednesday, 2/12/97   ·   For:  12/31/96   ·   Accession #:  912057-97-4594   ·   File #:  0-28016

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  As Of                Filer                Filing    For·On·As Docs:Size              Issuer               Agent

 2/12/97  Biopsys Medical Inc               10-Q       12/31/96    3:30K                                    Merrill Corp/FA

Quarterly Report   —   Form 10-Q
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 10-Q        Quarterly Report                                      14     55K 
 2: EX-11.1     Statement re: Computation of Earnings Per Share        1      7K 
 3: EX-27       Financial Data Schedule (Pre-XBRL)                     2      8K 


10-Q   —   Quarterly Report
Document Table of Contents

Page (sequential) | (alphabetic) Top
 
11st Page   -   Filing Submission
3Item 1. Financial Statements
7Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations
11Item 1. Legal Proceedings
"Item 2. Changes in Securities
"Item 3. Defaults in Senior Securities
"Item 4. Submission of Matters to A Vote of Security Holders
12Item 5. Other Information
"Item 6. Exhibits and Reports on Form 8-K
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UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) [ X ] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended December 31, 1996 -------------------------------------------------- OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to ------------------ --------------------------- Commission File 0-28016 Number Biopsys Medical, Inc. ------------------------------------------------------------ (Exact name of registrant as specified in its charter) Delaware 33-0578012 -------------------------------------------- -------------------- State or other jurisdiction of incorporation (I.R.S. Employer or organization) Identification No.) 3 Morgan, Irvine CA 92618 ---------------------------------------------------------------------------- (address of principal executive offices) (Zip Code) 714-460-7800 ---------------------------------------------------------------------------- (Registrant's telephone number, including area code) ---------------------------------------------------------------------------- (Former name, former address and 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. Yes X No ----- ----- As of January 29, 1997, 9,830,713 shares of Common Stock were issued and outstanding.
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BIOPSYS MEDICAL, INC. FORM 10-Q For the Three and Six Months Ended December 31, 1996 INDEX PAGE ---- Facing Sheet 1 Index 2 Part I. Financial Information Item 1. a) Balance sheets at December 31, 1996 and June 30, 1996 3 b) Statements of operations for the three month and six month periods ended December 31, 1996 and 1995 4 c) Statements of cash flows for the six month periods ended December 31, 1996 and 1995 5 d) Note to financial statements 6 Item 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 7 Part II. Other Information 11 Signature 13 Index to Exhibits 14 2
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PART 1: FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS BIOPSYS MEDICAL, INC. BALANCE SHEETS ASSETS December 31, June 30, --------------------------- 1996 1996 ----------- ----------- (unaudited) CURRENT ASSETS: Cash and cash equivalents $ 7,019,000 $12,122,000 Short-term investments 8,790,000 9,405,000 Accounts receivable, net 2,317,000 985,000 Inventories 2,386,000 1,581,000 Prepaid expenses and other current assets 561,000 141,000 ----------- ----------- Total current assets 21,073,000 24,234,000 LONG-TERM INVESTMENTS 18,914,000 15,860,000 PROPERTY AND EQUIPMENT, net 986,000 776,000 OTHER ASSETS 32,000 44,000 ----------- ----------- $41,005,000 $40,914,000 ----------- ----------- ----------- ----------- LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable $ 922,000 $ 1,270,000 Accrued expenses 775,000 561,000 ----------- ----------- Total current liabilities 1,697,000 1,831,000 COMMITMENTS - - STOCKHOLDERS' EQUITY Common Stock, $.001 par value; 50,000,000 shares authorized; 9,793,377 shares issued and outstanding 10,000 10,000 Additional paid-in capital 45,095,000 45,092,000 Accumulated deficit (6,609,000) (6,615,000) Deferred stock option compensation 812,000 596,000 ----------- ----------- Net stockholders' equity 39,308,000 39,083,000 ----------- ----------- $41,005,000 $40,914,000 ----------- ----------- ----------- ----------- See accompanying notes to financial statements. 3
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BIOPSYS MEDICAL, INC. STATEMENTS OF OPERATIONS (UNAUDITED) [Enlarge/Download Table] Three Months Ended December 31, Six Months Ended December 31, ------------------------------- ------------------------------- 1996 1995 1996 1995 ----------- ---------- ----------- ----------- Net Sales $ 3,302,000 $ 538,000 $ 5,703,000 $ 763,000 Cost of Sales 1,404,000 317,000 2,510,000 470,000 ----------- ---------- ----------- ----------- Gross Profit 1,898,000 221,000 3,193,000 293,000 Operating Expenses: Research and development 574,000 274,000 1,060,000 511,000 Selling, general and administrative 1,664,000 915,000 3,081,000 1,418,000 ----------- ---------- ----------- ----------- Total operating expenses 2,238,000 1,189,000 4,141,000 1,929,000 ----------- ---------- ----------- ----------- Interest income 484,000 71,000 953,000 135,000 Interest expense - - - (13,000) ----------- ---------- ----------- ----------- Net income (loss) $ 144,000 $ (897,000) $ 5,000 $(1,514,000) ----------- ---------- ----------- ----------- ----------- ---------- ----------- ----------- Net income (loss) per share $ 0.01 $ (0.12) $ 0.00 $ (0.20) ----------- ---------- ----------- ----------- ----------- ---------- ----------- ----------- Weighted average shares outstanding 11,055,000 7,600,000 10,983,000 7,570,000 See accompanying notes to financial statements. 4
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BIOPSYS MEDICAL, INC. STATEMENTS OF CASH FLOWS (UNAUDITED) [Enlarge/Download Table] Six Months Ended December 31, ------------------------------- 1996 1995 ----------- ----------- CASH FLOWS FROM OPERATING ACTIVITIES: Net income (loss) $ 5,000 $(1,514,000) Adjustments to reconcile net income (loss) to net cash used in operating activities: Depreciation and amortization 120,000 43,000 Deferred Compensation 217,000 199,000 Changes in assets and liabilities: Accounts receivable (1,332,000) (264,000) Prepaid expenses and other current assets (420,000) (5,000) Inventories (805,000) (511,000) Accounts payable and accrued expenses (134,000) 290,000 ----------- ----------- Net cash used in operating activities (2,349,000) (1,762,000) CASH FLOWS FROM INVESTING ACTIVITIES: Acquisition of property and equipment (317,000) (267,000) Short-term investment maturities 615,000 - Short-term investment purchases - (1,516,000) Long-term investment purchases (3,054,000) - ----------- ----------- Net cash used in investing activities (2,756,000) (1,783,000) CASH FLOWS FROM FINANCING ACTIVITIES: Net proceeds from issuance common stock 2,000 7,000 Net proceeds from issuance of Series C preferred stock - 6,495,000 ----------- ----------- Net cash provided by financing activities 2,000 6,502,000 ----------- ----------- NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (5,103,000) 2,957,000 CASH AND CASH EQUIVALENTS, beginning of period 12,122,000 13,000 ----------- ----------- CASH AND CASH EQUIVALENTS, end of period $ 7,019,000 $ 2,970,000 ----------- ----------- ----------- ----------- SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION Cash paid for income taxes $ - $ 800 ----------- ----------- ----------- ----------- Cash paid for interest $ - $ - ----------- ----------- ----------- ----------- See accompanying notes to financial statements. 5
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BIOPSYS MEDICAL, INC. NOTES TO FINANCIAL STATEMENTS (UNAUDITED) 1. BASIS OF PRESENTATION The accompanying balance sheet as of December 31, 1996 and the statements of operations and cash flows for the three months and six months ended December 31, 1996 and 1995 have been prepared by Biopsys Medical, Inc.( the "Company"), without audit. In the opinion of management, all adjustments necessary to present fairly the financial position, results of operations, and cash flows at December 31, 1996, and for all periods presented, have been made. Although the Company believes that the disclosures in these financial statements are adequate to make the information presented not misleading, certain information and footnote disclosures required by Generally Accepted Accounting Principles for complete financial statements have been omitted pursuant to the rules and regulations of the Securities and Exchange Commission ("SEC"). This financial data should be reviewed in conjunction with the audited financial statements and notes thereto included in the Company's Form 10-K for the year ended June 30, 1996. The results of operations for the three months and six months ended December 31, 1996 may not necessarily be indicative of the operating results for the full 1997 fiscal year. 6
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ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS The following discussion of the financial condition and results of operations of the Company should be read in conjunction with the unaudited Financial Statements and related Note thereto included in Part I - Item 1 of this Form 10-Q and with the Financial Statements and related Notes thereto included in its June 30, 1996 Annual Report on Form 10-K. This Report on Form 10-Q contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Actual events or results may differ materially from those projected in the forward-looking statements as a result of the factors described herein and in the documents incorporated herein by reference. Such forward-looking statements include, but are not limited to, statements concerning the Company's operating and capital requirements. OVERVIEW Since its inception in July 1993, the Company has been engaged in the design, development, clinical testing and, more recently, the manufacture and sale of the Mammotome Biopsy System. The Company received clearance of its 510(k) premarket notification for the Mammotome Biopsy System from the FDA in April 1995, began limited sales to selected customers in May 1995 and commercially introduced the Mammotome Biopsy System in August 1995. For the three and six months ended December 31, 1996, net sales of the Mammotome Biopsy System totaled $3,302,000 and $5,703,000, respectively. As of December 31, 1996, the Mammotome Biopsy System had been used in approximately 40,000 breast biopsy procedures at approximately 416 sites primarily in the United States. The Company has a limited history of operations and has experienced significant operating losses since inception. As of December 31, 1996 the Company had an accumulated deficit of approximately $6.6 million. Results of operations may fluctuate significantly from quarter to quarter and will depend upon numerous factors, including the extent to which the Company's products continue to gain market acceptance, actions relating to regulatory and reimbursement matters, progress of clinical trials, introduction of alternative means for less-invasive breast biopsy by competitors of the Company, pricing of competitive products and the cost and effect of promotional discounts and marketing programs. There can be no assurance that the Company will successfully commercialize the Mammotome Biopsy System or achieve significant revenues or profitability. Furthermore, although the Company achieved profitability in the quarter ended December 31, 1996, there can be no assurance that such levels of revenues and profitability will be sustained on a quarterly or annual basis, or at all. The Mammotome procedure requires the use of an imaging modality during the procedure. Currently, the only imaging modality with which the Mammotome Biopsy System is compatible is a prone stereotactic x-ray imaging table. Two companies, Fischer and Lorad, have sold substantially all of the approximately 1,000 prone stereotactic imaging tables installed in the United States. The Company has established non-exclusive marketing arrangements with Fischer and Lorad under which Fischer and Lorad can purchase Mammotome drive units from the Company at a discount from list price and can then bundle Mammotome drive units with stereotactic imaging tables for sale to customers. However, Mammotome probes and other disposable products related to the Mammotome Biopsy System are purchased by the customer directly from the Company, not from Fischer or Lorad. There can be no assurance that Fischer and Lorad will purchase or promote the Mammotome drive unit or that they will continue their marketing arrangements with the Company. Lorad also has an arrangement with United States Surgical Corporation ("USSC"), a competitor of the Company, under which Lorad manufactures stereotactic tables for USSC on a private label basis. In addition, Fischer and Lorad may have additional arrangements to market other competing biopsy systems. There can be no assurance that these or other imaging equipment manufacturers will not redesign the stereotactic tables so that they would not be compatible with the Mammotome Biopsy System. The failure or loss of such marketing arrangements could have a material adverse affect on the Company's business, financial condition and results of operations. 7
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The Company has limited experience in manufacturing the Mammotome Biopsy System. If the Company is unable to manufacture an adequate number of drive units or probes on a cost-effective and timely basis, it would have a material adverse effect on the Company's ability to realize significant product revenues for at least the next several quarters. The Company currently contracts with third parties to manufacture certain components of the Mammotome Biopsy System. Final assembly, sterilization and packaging of the Mammotome Biopsy System is currently performed by the Company in-house and by contract manufacturers. The Company has limited capacity to manufacture the Mammotome Biopsy System and will be required to increase its in-house capability to manufacture more of the system's components. There can be no assurance that the Company will be able to attract, train and retain the required personnel or will be able to increase its manufacturing capability in a timely manner, or at all. There can be no assurance that reliable, high-volume manufacturing can be established or maintained at commercially reasonable costs on a timely basis, or at all. If the Company is unable to increase its in-house manufacturing capability, the Company may need to obtain alternative manufacturing facilities or establish additional contract manufacturing for its products. Delays associated with, or the inability to establish, such additional capacity could have a material adverse affect on the Company's business, financial condition and results of operations. The Company purchases components used in the Mammotome Biopsy System from various suppliers. A limited number of parts and components are currently available only from single sources. The Company is in the process of qualifying additional sources for these components. There can be no assurance that the Company will be successful in qualifying any additional sources on a timely basis, or at all. Medical device companies frequently experience difficulties in obtaining required quantities of components necessary to manufacture their products. For example, the industry has experienced shortages of the type of stainless steel used in the Mammotome probes, and there can be no assurance that such shortages will not occur in the future. If the Company or any of its contract manufacturers encounter future manufacturing difficulties, including problems involving production yields, quality control and assurance, shortages of components or shortages of qualified personnel, it could have a material adverse effect on the Company's business, financial condition and results of operations. In addition, prior to international commercialization, the Company will be required to attain and maintain compliance with GMP requirements and ISO 9001 standards. Failure to either attain or maintain compliance with the applicable regulatory requirements of various regulatory agencies would have a material adverse effect on the Company's business, financial condition and results of operations. Biopsys has during the past several months engaged in discussions and correspondence with the FDA's 510(k) Reviewing Division regarding the Mammotome system and the FDA's concerns that devices cleared under 510(k) premarket notifications for diagnostic tissue sampling are being used for excision of tissue. The Company's discussions with the Reviewing Division resulted in defining the procedural steps necessary to fulfill the agency's requests and desire to establish consistent indications and promotional materials for all breast biopsy devices. As a result, on February 3 and 4, 1997, Biopsys advised the FDA that it would comply with the requests and file a stand alone 510(k) application for the Mammotome specifically directed towards breast biopsy for diagnostic purposes. However, on February 5, 1997, the Company received a warning letter concerning the labeling and promotion of the Mammotome system from a different FDA division than the division involved in previous discussions. The Company believes that the commitments already made to the FDA should help to provide a resolution of the principal issues identified in the warning letter. However, although the Company currently believes that the resolution of these matters with the FDA will not have a material impact on its business or operations, the Company cannot predict how long it will take for resolution of these matters. 8
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RESULTS OF OPERATIONS THREE MONTHS ENDED DECEMBER 31, 1996 AND 1995 Net sales for the three months ended December 31, 1996 were $3,302,000 compared to $538,000 during the three months ended December 31, 1995. The Company commenced commercial shipments of its Mammotome Biopsy System in August 1995. Net sales for the three months ended December 31, 1996 reflect sales of 99 Mammotome drive units and approximately 15,000 disposable probes compared to 32 Mammotome drive units and approximately 2,600 disposable probes in the three months ended December 31, 1995. During the three months ended December 31, 1996, cost of sales totaled $1,404,000, or 42.5% of net sales compared to $317,000 or 59% of net sales in the prior year. The decrease in cost of sales as a percentage of net sales and resulting higher gross profit is primarily related to a higher sales mix of disposable probes which carry a higher gross profit. Research and development expenses increased 109% to $574,000 during the three months ended December 31, 1996 from $274,000 during the three months ended December 31, 1995. This increase was primarily due to research and development expenses associated with the continued development of the 11-gauge probe, the MicroMark Clip, software and ultrasound related products. Selling, general and administrative expenses increased 82% to $1,664,000 during the three months ended December 31, 1996 from $915,000 during the three months ended December 31, 1995. This increase was primarily due to the hiring of sales personnel, increased marketing activities and increases in administrative personnel and related costs to support increased commercial sales of the Mammotome Biopsy System. Interest income increased to $484,000 during the three months ended December 31, 1996 from $71,000 during the three months ended December 31, 1995. The increase was due to higher cash balances and short-term and long-term investments associated with completion of the Company's initial public offering in May 1996. SIX MONTHS ENDED DECEMBER 31, 1996 AND 1995 Net sales for the six months ended December 31, 1996 were $5,703,000 compared to $763,000 during the six months ended December 31, 1995. Net sales for the six months ended December 31, 1996 reflect sales of 196 Mammotome drive units and approximately 26,000 disposable probes compared to 52 Mammotome drive units and approximately 3,500 disposable probes in the six months ended December 31, 1995. During the six months ended December 31, 1996, cost of sales totaled $2,510,000, or 44% of net sales compared to $470,000, or 61.5% of net sales in the prior year. The decrease in cost of sales as a percentage of net sales and resulting higher gross profit is primarily related to a higher sales mix of disposable probes which carry a higher gross profit. Research and development expenses increased 107% to $1,060,000 during the six months ended December 31, 1996 from $511,000 during the six months ended December 31, 1995. This increase was primarily due to research and development expenses associated with the continued development of the 11-gauge probe, the MicroMark Clip, software and ultrasound related products. Selling, general and administrative expenses increased 117% to $3,081,000 during the six months ended December 31, 1996 from $1,418,000 during the six months ended December 31, 1995. This increase was primarily due to the hiring of sales personnel, increased marketing activities and increases in administrative personnel and related costs to support commercial sales of the Mammotome Biopsy System. 9
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Interest income increased to $953,000 during the six months ended December 31, 1996 from $122,000, net during the six months ended December 31, 1995. The increase was due to higher cash balances and short-term and long-term investments associated with completion of the Company's initial public offering in May 1996. LIQUIDITY AND CAPITAL RESOURCES In May 1996, the Company completed an initial public offering of 2,587,500 shares of common stock (including the underwriters overallotment of 337,500 shares) at $15.00 per share. Net proceeds to the Company were approximately $35.3 million. From inception through April 1996, the Company financed its operations primarily through the private placement of equity securities totaling $9.7 million. These equity securities were converted to common stock in conjunction with the initial public offering. As of December 31, 1996, cash, cash equivalents, short-term and long-term investments totaled $34.7 million. The Company's cash used in operating activities increased to $2.3 million for the six months ended December 31, 1996 from $1.8 million for the six months ended December 31, 1995, primarily resulting from increases in accounts receivable and inventories related to the commercial introduction of the Mammotome Biopsy System. The Company's principal source of liquidity at December 31, 1996 consisted of cash, cash equivalents, short-term and long-term investments of $34.7 million. The Company has adopted investment guidelines which restrict the types and quality of investments the Company is authorized to enter into. At December 31, 1996, the Company had invested approximately $1.2 million in money market funds, approximately $15.8 million in commercial paper and short term corporate bonds rated a minimum of A1/P1, and approximately $17.7 million in U.S. government treasury notes or long term corporate bonds. At December 31, 1996, the Company had no long term debt. The Company has never had and currently does not have commitments for credit facilities, such as revolving credit agreements or lines of credit, that could provide additional working capital. The Company believes that the current cash balances and short-term and long-term investments will be sufficient to meet the Company's operating and capital requirements through fiscal 1997. The Company's future liquidity and capital requirements will depend on numerous factors, including the extent to which the Company's Mammotome Biopsy System gains market acceptance, the timing of regulatory actions regarding the Company's potential future products, the costs and timing of expansion of sales, marketing and manufacturing activities, obtaining and enforcing patents important to the Company's business, results of clinical trials and competition. There can be no assurance that the Company will not be required to raise additional capital, or that such capital will be available on acceptable terms, or at all. 10
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PART II. OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS None. ITEM 2. CHANGES IN SECURITIES None. ITEM 3 DEFAULTS IN SENIOR SECURITIES None ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS On December 9, 1996, at the Company's Annual Meeting of Stockholders, the holders of Common Stock of the Company (i) elected two Class I directors to serve for terms of three years expiring upon the 1999 Annual Meeting of Stockholders and elected two Class III directors to serve for terms of two years expiring upon the 1998 Annual Meeting of Stockholders, and (ii) ratified the appointment of Deloitte and Touche LLP as independent auditors for the fiscal year ending June 30, 1997. The voting on each matter is set forth below. 1. Votes cast for election of directors. Nominee Total For Total Withheld Each Nominee From Each Nominee -------------------------------------------------------------------- CLASS I DIRECTORS: David W. Chonette 8,743,901 200 Thomas J. Fogarty, M.D. 8,743,901 200 CLASS III DIRECTORS: Norwick B.H. Goodspeed 8,743,601 500 Edgar J. Cummins 8,743,601 500 2. Votes cast to ratify the appointment of Deloitte & Touche LLP. FOR AGAINST ABSTAIN BROKER NON VOTE 8,743,251 750 100 -0- 11
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ITEM 5. OTHER INFORMATION None ITEM 6. EXHIBITS AND REPORTS ON FORM 8-K PAGE ---- (a) 11.1 Computation of net income (loss) per share 15 27 Financial Data Schedule 16 (b) Reports on Form 8-K None 12
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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. BIOPSYS MEDICAL, INC. By: /s/ Steven J. Naber ----------------------------------- Steven J. Naber Vice President of Finance and Chief Financial Officer (Duly Authorized and Principal Financial and Accounting Officer) Date: February 11, 1997 13
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BIOPSYS MEDICAL, INC. INDEX TO EXHIBITS EXHIBIT SEQUENTIALLY NUMBER DESCRIPTION NUMBERED PAGE ------- ------------ ------------- 11.1 Statement Re: Computation of Net Income (Loss) Per Share 15 27 Financial data schedule 16 14

Dates Referenced Herein   and   Documents Incorporated by Reference

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This ‘10-Q’ Filing    Date First  Last      Other Filings
6/30/9711
Filed on:2/12/97
2/11/9713
2/5/978
1/29/971
For Period End:12/31/96110
12/9/9611DEF 14A
6/30/966710-K
12/31/95210
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