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Biopsys Medical Inc – ‘10-Q’ for 3/31/97

As of:  Monday, 5/5/97   ·   For:  3/31/97   ·   Accession #:  912057-97-15494   ·   File #:  0-28016

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

 5/05/97  Biopsys Medical Inc               10-Q        3/31/97    3:28K                                    Merrill Corp/FA

Quarterly Report   —   Form 10-Q
Filing Table of Contents

Document/Exhibit                   Description                      Pages   Size 

 1: 10-Q        Quarterly Report                                      13     52K 
 2: EX-11.1     Statement re: Computation of Earnings Per Share        1      7K 
 3: EX-27       Financial Data Schedule                                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
"Item 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 March 31, 1997 ------------------------------------------- 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 (I.R.S. Employer Identification No.) incorporation or organization) 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 April 25, 1997, 9,888,567 shares of Common Stock were issued and outstanding.
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BIOPSYS MEDICAL, INC. FORM 10-Q For the Three and Nine Months Ended March 31, 1997 INDEX PAGE ---- Facing Sheet 1 Index 2 Part I. Financial Information Item 1. a) Balance sheets at March 31, 1997 and June 30, 1996 3 b) Statements of operations for the three month and nine month periods ended March 31, 1997 and 1996 4 c) Statements of cash flows for the nine month periods ended March 31, 1997 and 1996 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 12 Index to Exhibits 13 2
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PART 1: FINANCIAL INFORMATION ITEM 1. FINANCIAL STATEMENTS BIOPSYS MEDICAL, INC. BALANCE SHEETS ASSETS March 31, June 30, 1997 1996 ------------ ------------- (unaudited) CURRENT ASSETS: Cash and cash equivalents $ 6,538,000 $ 12,122,000 Short-term investments 15,222,000 9,405,000 Accounts receivable, net 2,392,000 985,000 Inventories 2,602,000 1,581,000 Prepaid expenses and other current assets 662,000 141,000 ------------ ------------- Total current assets 27,416,000 24,234,000 LONG-TERM INVESTMENTS 13,457,000 15,860,000 PROPERTY AND EQUIPMENT, net 1,390,000 776,000 OTHER ASSETS 26,000 44,000 ------------ ------------- $ 42,289,000 $ 40,914,000 ------------ ------------- ------------ ------------- LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable $ 969,000 $ 1,270,000 Accrued expenses 1,064,000 561,000 ------------ ------------- Total current liabilities 2,033,000 1,831,000 COMMITMENTS - - STOCKHOLDERS' EQUITY Common Stock, $.001 par value; 50,000,000 shares authorized; 9,884,900 shares issued and outstanding 10,000 10,000 Additional paid-in capital 45,363,000 45,092,000 Accumulated deficit (6,008,000) (6,615,000) Deferred stock option compensation 891,000 596,000 ------------ ------------- Net stockholders' equity 40,256,000 39,083,000 ------------ ------------- $ 42,289,000 $ 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 March 31, Nine Months Ended March 31, ---------------------------- --------------------------- 1997 1996 1997 1996 ------------ ------------ ------------- ------------ Net Sales $ 4,342,000 $ 1,042,000 $ 10,045,000 $ 1,805,000 Cost of Sales 1,726,000 581,000 4,236,000 1,051,000 ------------ ------------ ------------- ------------ Gross Profit 2,616,000 461,000 5,809,000 754,000 Operating Expenses: Research and development 591,000 516,000 1,650,000 1,027,000 Selling, general and administrative 1,903,000 1,021,000 4,984,000 2,439,000 ------------ ------------ ------------- ------------ Total operating expenses 2,494,000 1,537,000 6,634,000 3,466,000 ------------ ------------ ------------- ------------ Income (loss) from operations 122,000 (1,076,000) (825,000) (2,712,000) Interest income 479,000 45,000 1,432,000 180,000 Interest expense - - - (13,000) ------------ ------------ ------------- ------------ Net income (loss) $ 601,000 $ (1,031,000) $ 607,000 $ (2,545,000) ------------ ------------ ------------- ------------ ------------ ------------ ------------- ------------ Net income (loss) per share $ 0.05 $ (0.13) $ 0.06 $ (0.33) ------------ ------------ ------------- ------------ ------------ ------------ ------------- ------------ Weighted average shares outstanding 11,217,000 7,641,000 11,031,000 7,619,000 See accompanying notes to financial statements. 4
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BIOPSYS MEDICAL, INC. STATEMENTS OF CASH FLOWS (UNAUDITED) [Enlarge/Download Table] Nine Months Ended March 31, ------------------------------ 1997 1996 ------------ ------------ CASH FLOWS FROM OPERATING ACTIVITIES: Net income (loss) $ 607,000 $ (2,545,000) Adjustments to reconcile net income (loss) to net cash used in operating activities: Depreciation and amortization 202,000 70,000 Deferred Compensation 295,000 444,000 Changes in assets and liabilities: Accounts receivable (1,407,000) (639,000) Prepaid expenses and other current assets (521,000) (50,000) Inventories (1,021,000) (680,000) Other assets - (137,000) Accounts payable and accrued expenses 202,000 617,000 ------------ ------------ Net cash used in operating activities (1,643,000) (2,920,000) CASH FLOWS FROM INVESTING ACTIVITIES: Acquisition of property and equipment (798,000) (417,000) Short-term investment maturities 642,000 477,000 Short-term investment purchases - (1,516,000) Long-term investment purchases (4,056,000) - ------------ ------------ Net cash used in investing activities (4,212,000) (1,456,000) CASH FLOWS FROM FINANCING ACTIVITIES: Net proceeds from issuance common stock 271,000 8,000 Net proceeds from issuance of Series C preferred stock - 6,495,000 ------------ ------------ Net cash provided by financing activities 271,000 6,503,000 ------------ ------------ NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS (5,584,000) 2,127,000 CASH AND CASH EQUIVALENTS, beginning of period 12,122,000 13,000 ------------ ------------ CASH AND CASH EQUIVALENTS, end of period $ 6,538,000 $ 2,140,000 ------------ ------------ ------------ ------------ SUPPLEMENTAL DISCLOSURE OF CASH FLOW INFORMATION Cash paid for income taxes $ - $ 800 ------------ ------------ ------------ ------------ Cash paid for interest $ - $ - ------------ ------------ ------------ ------------ NON-CASH TRANSACTION: During the nine months ended March 31, 1997 the Company re-classified $6,423,000 of long-term investments to short-term investments as the original maturity dates of the investments became within twelve months of the balance sheet date. 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 March 31, 1997 and the statements of operations and cash flows for the three months and nine months ended March 31, 1997 and 1996 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 March 31, 1997, 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 nine months ended March 31, 1997 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 nine months ended March 31, 1997, net sales totaled $4,342,000 and $10,045,000, respectively. As of March 31, 1997, the Mammotome Biopsy System had been used in approximately 58,000 breast biopsy procedures at approximately 516 sites primarily in the United States. The Company has a limited history of operations and experienced significant operating losses from inception through December 31, 1996. As of March 31, 1997 the Company had an accumulated deficit of approximately $6.0 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 continue to successfully commercialize the Mammotome Biopsy System or achieve significant revenues or profitability. Furthermore, although the Company achieved profitability in the quarter ended March 31, 1997, 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 primary 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 1,200 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 include 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. 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. 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. 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 were 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. On February 24, 1997 the Company announced that it had received confirmation from the FDA that all issues set-out in the February 5, 1997 warning letter concerning the labeling and promotion of the Mammotome Biopsy System had been satisfactorily resolved. On April 2, 1997 the Company announced that it had received 510(k) premarket notification clearance from the FDA for the Mammotome Biopsy System specifically for breast biopsy for diagnostic purposes. 8
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RESULTS OF OPERATIONS THREE MONTHS ENDED MARCH 31, 1997 AND 1996 Net sales for the three months ended March 31, 1997 were $4,342,000 compared to $1,042,000 during the three months ended March 31, 1996. The Company commenced commercial shipments of its Mammotome Biopsy System in August 1995. Net sales for the three months ended March 31, 1997 reflect sales of 100 Mammotome drive units and approximately 18,000 disposable probes compared to 69 Mammotome drive units and approximately 4,600 disposable probes in the three months ended March 31, 1996. During the three months ended March 31, 1997, cost of sales totaled $1,726,000, or 39.8% of net sales compared to $581,000 or 55.8% 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 15% to $591,000 during the three months ended March 31, 1997 from $516,000 during the three months ended March 31, 1996. This increase was primarily due to research and development expenses associated with the continued development of software and ultrasound related products. Selling, general and administrative expenses increased 86% to $1,903,000 during the three months ended March 31, 1997 from $1,021,000 during the three months ended March 31, 1996. 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 $479,000 during the three months ended March 31, 1997 from $45,000 during the three months ended March 31, 1996. 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. NINE MONTHS ENDED MARCH 31, 1997 AND 1996 Net sales for the nine months ended March 31, 1997 were $10,045,000 compared to $1,805,000 during the nine months ended March 31, 1996. Net sales for the nine months ended March 31, 1997 reflect sales of 296 Mammotome drive units and approximately 44,000 disposable probes compared to 121 Mammotome drive units and approximately 8,100 disposable probes in the nine months ended March 31, 1996. During the nine months ended March 31, 1997, cost of sales totaled $4,236,000, or 42% of net sales compared to $1,051,000, or 58% 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 61% to $1,650,000 during the nine months ended March 31, 1997 from $1,027,000 during the nine months ended March 31, 1996. 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 104% to $4,984,000 during the nine months ended March 31, 1997 from $2,439,000 during the nine months ended March 31, 1996. 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 $1,432,000 during the nine months ended March 31, 1997 from $167,000, net during the nine months ended March 31, 1996. 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 March 31, 1997, cash, cash equivalents, short-term and long-term investments totaled $35.2 million. The Company's cash used in operating activities decreased to $1.6 million for the nine months ended March 31, 1997 from $2.9 million for the nine months ended March 31, 1996 primarily resulting from changing a net loss of $2,545,000 to net income of $607,000 partially offset by increases in accounts receivable and inventories related to increased sales of the Mammotome Biopsy System. The Company's principal source of liquidity at March 31, 1997 consisted of cash, cash equivalents, short-term and long-term investments of $35.2 million. The Company has adopted investment guidelines which restrict the types and quality of investments the Company is authorized to enter into. At March 31, 1997, the Company had invested approximately $1.1 million in money market funds, approximately $21.5 million in commercial paper and short term corporate bonds, and approximately $12.6 million in U.S. government treasury notes or long term corporate bonds. At March 31, 1997, 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 None 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 14 27 Financial Data Schedule 15 (b) Reports on Form 8-K None 11
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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 Vice President of Finance and Chief Financial Officer (Duly Authorized and Principal Financial and Accounting Officer) Date: April 25, 1997 12
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BIOPSYS MEDICAL, INC. INDEX TO EXHIBITS [Download Table] EXHIBIT SEQUENTIALLY NUMBER DESCRIPTION NUMBERED PAGE ------ ----------- ------------- 11.1 Statement Re: Computation of Net Income (Loss) Per Share 14 27 Financial data schedule 15 13

Dates Referenced Herein   and   Documents Incorporated by Reference

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This ‘10-Q’ Filing    Date First  Last      Other Filings
Filed on:5/5/97
4/25/97112
4/2/978
For Period End:3/31/97110
2/24/978
2/5/978
12/31/96710-Q
6/30/966710-K
3/31/96210
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