-----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, QWDzyG2TURmbl13Qd5R2DWY8ElBHnE5+H+9VE0Qem3aUTKCwubCHDyP+/55YwFT8 eMzrYDQfRabOBf+yKSjb8g== 0001019687-04-000374.txt : 20040223 0001019687-04-000374.hdr.sgml : 20040223 20040223172628 ACCESSION NUMBER: 0001019687-04-000374 CONFORMED SUBMISSION TYPE: 10QSB PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20031231 FILED AS OF DATE: 20040223 FILER: COMPANY DATA: COMPANY CONFORMED NAME: TRIMEDYNE INC CENTRAL INDEX KEY: 0000357001 STANDARD INDUSTRIAL CLASSIFICATION: ELECTROMEDICAL & ELECTROTHERAPEUTIC APPARATUS [3845] IRS NUMBER: 363094439 STATE OF INCORPORATION: NV FISCAL YEAR END: 0930 FILING VALUES: FORM TYPE: 10QSB SEC ACT: 1934 Act SEC FILE NUMBER: 000-10581 FILM NUMBER: 04622848 BUSINESS ADDRESS: STREET 1: 15091 BAKE PARKWAY CITY: IRVINE STATE: CA ZIP: 92619 BUSINESS PHONE: 7145595300 MAIL ADDRESS: STREET 1: 15091 BAKE PARKWAY CITY: IRVINE STATE: CA ZIP: 92619 10QSB 1 trimedyne_10q-123103.txt SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 FORM 10-QSB QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15 (d) OF THE SECURITIES EXCHANGE ACT OF 1934 FOR THE QUARTER ENDED COMMISSION FILE NUMBER DECEMBER 31, 2003 0-10581 - ----------------- ------- TRIMEDYNE, INC. (Exact name of Registrant as specified in its charter) Nevada 36-3094439 (State or other jurisdiction (IRS Employer Identification Number) of incorporation or organization) 15091 Bake Parkway, Irvine, CA 92618 (Address of principal executive offices) (Zip Code) (949/951-3800) (Registrant's telephone number, including area code) Not Applicable (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), (2) has been subject to such filing requirements for the past 90 days. YES [X] NO [_] Indicate the number of shares outstanding of each of the issuer's class of common stock, as of the last practicable date. Class Outstanding at February 23, 2004 - ---------------------------- -------------------------------- Common Stock, $.01 par value 14,534,831 shares TRIMEDYNE, INC. Page Number ----------- PART I. Financial Information 3 ITEM 1. Financial Statements (Unaudited) 3 Consolidated Balance Sheet 3 Consolidated Statements of Operations 4 Consolidated Statements of Cash Flows 5 Notes to Consolidated Financial Statements 6 ITEM 2. Management's Discussion and Analysis of Financial Condition and Results of Operations 12 ITEM 3. Controls and Procedures 14 PART II. Other Information 15 SIGNATURE PAGE 16 CERTIFICATIONS 17 2 TRIMEDYNE, INC. CONSOLIDATED BALANCE SHEET (UNAUDITED) ASSETS December 31, 2003 ------------- Current assets: Cash and cash equivalents $ 1,316,000 Trade accounts receivable, net of allowance for doubtful accounts of $82,000 656,000 Inventories 1,515,000 Other 98,000 ------------ Total current assets 3,585,000 Goodwill 544,000 Other assets 45,000 Property and equipment, net 474,000 ------------ $ 4,648,000 ============ LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 491,000 Accrued expenses 394,000 Deferred revenue 67,000 Accrued warranty 25,000 Current portion of long-term debt 12,000 ------------ Total current liabilities 989,000 Senior convertible secured notes due to officer 200,000 Accrued interest due officer 44,000 Long-term debt, net of current portion 8,000 ------------ Total liabilities 1,241,000 ------------ Stockholders' equity: Preferred stock - $0.01 par value, 1,000,000 shares authorized, none issued and outstanding Common stock - $0.01 par value; 30,000,000 shares authorized, 14,636,440 shares issued, 14,534,831 shares outstanding 147,000 Capital in excess of par value 47,915,000 Accumulated deficit (43,942,000) ------------ 4,170,000 Treasury stock, at cost (101,609 shares) (713,000) ------------ Total stockholders' equity 3,457,000 ------------ $ 4,648,000 ============ See accompanying notes to consolidated financial statements 3 TRIMEDYNE, INC. CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED) Three Months Ended December 31, 2003 2002 ------------ ------------ Net revenues $ 1,380,000 $ 1,685,000 Cost of revenues 704,000 862,000 ------------ ------------ Gross profit 676,000 823,000 Operating expenses: Selling, general and administrative 567,000 475,000 Research and development 67,000 67,000 ------------ ------------ Total operating expenses 634,000 542,000 ------------ ------------ Income from operations 42,000 281,000 ------------ ------------ Other income (expense) Micellaneous (expense) income (1,000) 1,000 Interest expense (12,000) (6,000) Loss on disposal of equipment (5,000) -- Settlements and recoveries 141,000 14,000 ------------ ------------ Total other income 123,000 9,000 ------------ ------------ Net income $ 165,000 $ 290,000 ============ ============ Basic net income per share $ 0.01 $ 0.02 ============ ============ Basic weighted average common shares outstanding 14,473,764 13,729,760 ============ ============ Diluted net income per share $ 0.01 $ 0.02 ============ ============ Diluted weighted average common shares outstanding 15,055,445 14,204,760 ============ ============ See accompanying notes to consolidated financial statements. 4 TRIMEDYNE, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)
Three Months Ended December 31, 2003 2002 ----------- ---------- Cash flows from operating activities: Net income $ 165,000 $ 290,000 Adjustment to reconcile net income to net cash provided by used in operating activities: Depreciation and amortization 62,000 31,000 Loss from disposal of property and equipment 5,000 -- Changes in operating assets and liabilities: Trade accounts receivable (19,000) (355,000) Inventories (10,000) 161,000 Other current assets 48,000 47,000 Accounts payable (33,000) (133,000) Accrued expenses (223,000) (85,000) Deferred income 8,000 8,000 Accrued warranty (17,000) (1,000) Current liabilities -- (5,000) ----------- ---------- Net cash used in operating activities (14,000) (42,000) Cash flows from investing activities: Purchase of property and equipment (46,000) -- ----------- ---------- Net cash used in investing activities (46,000) -- Cash flows from financing activities: Payments on long-term debt (9,000) (14,000) Excercise of stock options 39,000 -- ----------- ---------- Net cash provided by financing activities 30,000 -- ----------- ---------- Net decrease in cash and cash equivalents (30,000) (56,000) Cash and cash equivalents at beginning of period 1,346,000 317,000 ----------- ---------- Cash and cash equivalents at end of period $ 1,316,000 $ 261,000 =========== ========== See accompanying notes to consolidated financial statements 5
TRIMEDYNE, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS DECEMBER 31, 2003 (UNAUDITED) NOTE 1 - Summary of Significant Accounting Policies Principles of Consolidation The accompanying consolidated financial statements include the accounts of Trimedyne, Inc., its wholly owned subsidiary, Mobile Surgical Technologies, Inc. ("MST"), and its 90% owned subsidiary, Cardiodyne, Inc. ("Cardiodyne") (collectively, the "Company"). All intercompany accounts and transactions have been eliminated in consolidation. Unaudited Interim Financial Information In the opinion of management, the accompanying condensed consolidated financial statements contain all adjustments (consisting of only normal recurring adjustments) necessary to present fairly the Company's consolidated financial position as of December 31, 2003 and the results of operations and its cash flows for the three-month periods ended December 31, 2003 and 2002. Results for the three months ended December 31, 2003 are not necessarily indicative of the results to be expected for the year ending September 30, 2004. While management believes that the disclosures presented are adequate to make the information not misleading, it is suggested that these consolidated financial statements be read in conjunction with the consolidated financial statements and the notes included in the Company's 2003 annual report on Form 10-KSB. Certain prior period amounts have been reclassed to conform to the current period presentation. Accounts Receivable The Company performs ongoing credit evaluations of its customers and generally does not require collateral. The Company maintains reserves for potential credit losses and such losses have been within management's expectation. Revenue Recognition In accordance with Staff Accounting Bulletin 101, "Revenue Recognition in Financial Statements," the Company recognizes revenue from products sold once all of the following criteria for revenue recognition have been met: (i) persuasive evidence that an arrangement exists, (ii) the products have been shipped, (iii) the prices are fixed and determinable and not subject to refund or adjustment, and (iv) collection of the amounts due is reasonably assured. Revenues from the sale of delivery and disposable devices are recognized upon shipment and passage of title of the products, provided that all other revenue recognition criteria have been met. Generally, customers are required to insure the goods from the Company's place of business. Accordingly, the risk of loss transfers to the customer once the goods have been shipped from the Company's warehouse. The Company sells its products primarily through commission sales representatives in the United States and distributors in foreign countries. In cases where the Company utilizes distributors, it recognizes revenue upon shipment, provided that all other revenue recognition criteria have been met, and ownership risk has transferred. Goodwill Goodwill represents the excess of the cost over the acquired assets of MST. On October 1, 2002, the Company adopted the provisions of Statement of Financial Accounting Standards ("SFAS") No. 142, "Goodwill and Other Intangible Assets." As a result of adoption SFAS No. 142, the Company's goodwill is no longer amortized, but is subject to an annual impairment test, or whenever events or changes in circumstances indicate that the carrying value may not be recoverable. There was no impairment of goodwill at December 31, 2003. 6 Stock Option Plans The Company accounts for its stock-based compensation plans under the recognition and measurement principles of Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees," and related interpretations. The Company has adopted the disclosure provisions of SFAS No. 123, "Accounting for Stock-Based Compensation," as amended by SFAS No. 148, "Accounting for Stock-Based Compensation - Transition and Disclosure" - an amendment of FASB Statement No. 123. The following table illustrates the effect on net income and net income per share if the Company had applied the fair value recognition provisions of SFAS No. 123 to stock-based employee compensation:
Three Months Ended December 31, 2003 2002 ------------ ------------ Net income, as reported $ 165,000 $ 290,000 Deduct: total stock-based employee compensation expense determined under fair value based method for awards, net of related tax effects 28,000 23,000 ------------ ------------ Pro forma net income $ 137,000 $ 267,000 ============ ============ Net income per share - basic: As reported $ 0.01 $ 0.02 ============ ============ Pro forma $ 0.01 $ 0.02 ============ ============ Net income per share - diluted: As reported $ 0.01 $ 0.02 ============ ============ Pro forma $ 0.01 $ 0.02 ============ ============
The fair value of each option grant is estimated on the date of grant using the Black-Scholes option-pricing model with the following weighted-average assumptions used: Three Months Ended December 31, 2003 2002 ---------- ---------- Dividend yield -- -- Expected volatility 185% 114% Risk-free interest rate 2.25% 2.50% Expected lives 5 years 5 years The Black-Scholes option valuation model was developed for use in estimating the fair value of traded options that have no vesting restrictions and are fully transferable. In addition, option valuation models require the input of highly subjective assumptions, including the expected stock price volatility and time to exercise. Because awards held by employees and directors have characteristics significantly different from those of traded options, and because changes in the subjective input assumptions can materially affect the fair value estimate, in the opinion of management, the existing models do not necessarily provide a reliable single measure of the fair value of these options. 7 NOTE 2 - Balance Sheet Items December 31, 2003 ----------- Inventories consist of the following: Raw material $ 944,000 Work-in-process 407,000 Finished goods 164,000 ----------- Total inventory $ 1,515,000 =========== Property and equipment consist of the following: Furniture and equipment $ 2,355,000 Leasehold improvements 218,000 Other 166,000 ----------- 2,739,000 Less accumulated depreciation and amortization (2,265,000) ----------- Total property and equipment $ 474,000 =========== Accrued expenses consist of the following: Loss contigency $ 100,000 Accrued compensation 83,000 Sales and use tax 60,000 Accrued payroll tax 22,000 Sublease deposit 15,000 Customer deposits 12,000 Accrued insurance 10,000 Accrued commissions 9,000 Other 83,000 ----------- Total accrued expenses $ 394,000 =========== NOTE 3 - Earnings Per Share Information Basic income per share is based on the weighted-average number of shares of common stock outstanding during the period. Diluted income per share also includes the effect of stock options and other common stock equivalents outstanding during the period, and assumes the conversion of the Company's senior convertible secured notes due to officers for the period of time such notes were outstanding, if such stock options and convertible notes are dilutive. The following table sets forth the computation of the numerator and denominator of basic and diluted earnings per share: Three Months Ended December 31, 2003 2002 ----------- ----------- Denominator Weighted average common shares outstanding used in calculating basic earnings per share 14,473,764 13,729,760 Effect of Dilutive Options 106,681 -- Effect of Senior Convertible Secured Notes due to Officer 475,000 475,000 ----------- ----------- Weighted average common shares outstanding used in calculating diluted earnings per share 15,055,445 14,204,760 =========== =========== Numerator Net income $ 165,000 $ 290,000 Add - interest on Senior Convertible Secured Note due to Officer 6,000 6,000 ----------- ----------- Net income available to common shareholders $ 171,000 $ 296,000 =========== =========== 8 NOTE 4 - Contingencies Litigation The Company was a defendant and counterclaimant in Lumenis, Inc. ("Lumenis") v. Trimedyne, Inc. Lumenis alleged that the Company had infringed on two of its patents. The Company filed an answer to Lumenis' complaint and also filed counterclaims against Lumenis alleging infringement of two of the Company's patents, unfair business practices, libel and anti-trust violations. The Company was a party to a license agreement (the "License Agreement"), which required it to pay royalties to Lumenis. At September 30, 2003, the Company had accrued royalties under this license agreement in the amount of $88,000, which were in dispute. On November 25, 2003, the Company and Lumenis entered into a settlement agreement (the "Settlement Agreement"), under which the court dismissed the litigation between them. The Settlement Agreement also provided that Lumenis would apply a credit to royalties due by the Company under the License Agreement, and pay the Company $5,000 for the remaining overpayment of royalties due under the License Agreement. The Settlement Agreement also provided that the Company and Lumenis would enter into an original equipment manufacture ("OEM") agreement whereby Lumenis would pay the Company a technology access fee of $150,000 and purchase from the Company certain side-firing and angled-firing fiber optic devices, which Lumenis will market with its lasers, plus an amount equal to 7.5% of Lumenis' sales of side-firing and angled-firing devices manufactured by Lumenis or purchased by Lumenis from third-party suppliers. On January 30, 2004, the Company received $155,000 in connection with the terms of the Settlement Agreement, which will be recorded as other income in the subsequent period. Product liability The Company is currently a defendant in three product liability lawsuits. These cases relate to injuries that occurred in connection to medical procedures in which the Company's lasers were used. All of these cases are currently in litigation. The Company has insurance to cover product liability claims. This insurance provides the Company with $5,000,000 of coverage for each occurrence with a general aggregate of $5,000,000. Trimedyne's liability is limited to a maximum of $50,000 per occurrence unless the judgment against the Company exceeds the insurance coverage. In such case, Trimedyne would be liable for any liability in excess of $5,000,000. Management has recorded a loss contingency for these claims in the amount of $100,000 ($50,000 for each of the two claims), based on the deductible under the insurance policy. In another product liability lawsuit, the cost of defense has exceeded the insurance deductible that was accrued in prior periods. Management is not accruing any additional provision for this claim, as it is not expected that this claim will exceed the limits of the insurance coverage. In the ordinary course of business, the Company is from time to time involved in various pending or threatened legal actions. The litigation process is inherently uncertain and it is possible that the resolution of such matters might have a material adverse effect upon the financial condition and/or results of operations of the Company. However, in the opinion of the Company's management, matters currently pending or threatened against the Company, as discussed above, are not expected to have a material adverse effect on the financial position, results of operations or cash flows of the Company. Licensing The Company has license agreements with a number of universities and inventors, under which royalties on sales, if any, are payable. Sales of products covered by these licenses are presently not material. The Company has two license agreements with a competitor under which royalties are payable by the Company, one of which terminated on September 30, 2000. Patent applications have been filed with the U.S. Patent Office and U.S. Patents covering certain of the Company's products have been issued to officers and employees of the Company and have been assigned to the Company without royalty. The above patent applications are currently being processed by the U.S. Patent Office and, to the Company's knowledge, are proceeding in the normal course of review. NOTE 5 Other Income (Expense) During the three months ended December 31, 2003, the Company settled litigation with Lumenis which resulted in a reduction of $88,000 accrued for royalties. The Company also received $53,000 from an insurance settlement for a damaged laser. 9 NOTE 6 Segment Information The Company's revenue base is derived from the sales of medical products and services. Products consist of lasers, and related products such as disposable systems and component parts. Services consist of rentals, fees on a per-case basis, as well as service and warranty repairs and maintenance. Data with respect to these operating activities for the three months ended December 31, 2003 and December 31, 2002 are as follows:
For the quarter ended December 31, 2003 For the quarter ended December 31, 2002 Service and Service and Products Rental Total Products Rental Total --------------------------------------- ----------------------------------------- Revenue $ 965,000 $ 415,000 $ 1,380,000 $ 1,287,000 $ 398,000 $ 1,685,000 Cost of sales 464,000 240,000 704,000 634,000 228,000 862,000 --------------------------------------- ----------------------------------------- Gross Profit 501,000 175,000 676,000 653,000 170,000 823,000 Operating expenses: Selling, general and administrative 415,000 152,000 567,000 341,000 134,000 475,000 Research and development 67,000 -- 67,000 67,000 -- 67,000 --------------------------------------- ----------------------------------------- Income from operations $ 19,000 $ 23,000 42,000 $ 245,000 $ 36,000 281,000 ========================= ========================== Other Interest income (1,000) 1,000 Interest expense (12,000) (6,000) Loss on disposal of equipment (5,000) -- Settlements and recoveries 141,000 14,000 ----------- ------------ Net Income $ 165,000 $ 290,000 =========== ============
Sales and gross profit to customers by similar products and services for the three months ended December 31, 2003 (unaudited) and December 31, 2002 were: December 31, 2003 2002 ---------- ----------- By similar products and services: Revenues: Products: Laser equipment and accessories $ 84,000 $ 439,000 Delivery and disposable devices 881,000 848,000 Service and rental 415,000 398,000 ---------- ---------- Total $1,380,000 $1,685,000 ========== ========== Gross profit Products: Laser equipment and accessories $ 22,000 $ 200,000 Delivery and disposable devices 479,000 453,000 Service and rental 175,000 170,000 ---------- ---------- Total $ 676,000 $ 823,000 ========== ========== The Company's revenue base is derived from the sales of medical products and services on a worldwide basis originating from the United States. Export sales during the three months ended December 31, 2003 and December 31, 2002, were $264,000 and $415,000, respectively. Although discrete components that earn revenues and incur expenses exist, significant expenses such as research and development and corporate administration are not incurred by nor allocated to these operating units but rather are employed by the entire enterprise. Additionally, the chief operating decision maker evaluates resource allocation not on a product or geographic basis, but rather on an enterprise-wide basis. Therefore, the Company has concluded that it contains only one reportable segment, which is the medical systems business. 10 Sales in foreign countries for the quarters ended December 31, 2003 and December 31, 2002 accounted for approximately 19% and 25% of the Company's total sales, respectively. The breakdown by geographic region is as follows: Three months Three months ended December ended December 31, 2003 31, 2002 -------------- -------------- Asia $ 89,000 $ 238,000 Europe 163,000 165,000 Latin America -- 9,000 Middle East 9,000 3,000 Other 3,000 -- ------------ ----------- $ 264,000 $ 415,000 ============ =========== All long-lived assets were located in the United States during the three months ended December 31, 2003. 11 MANAGEMENT'S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION CRITICAL ACCOUNTING POLICIES Revenue Recognition In accordance with Staff Accounting Bulletin 101, "Revenue Recognition in Financial Statements," the Company recognizes revenue from products sold once all of the following criteria for revenue recognition have been met: (i) persuasive evidence that an arrangement exists, (ii) the products have been shipped, (iii) the prices are fixed and determinable and not subject to refund or adjustment, and (iv) collection of the amounts due is reasonably assured. Revenues from the sale of delivery and disposable devices are recognized upon shipment and passage of title of the products, provided that all other revenue recognition criteria have been met. Generally, customers are required to insure the goods from the Company's place of business. Accordingly, the risk of loss transfers to the customer once the goods have been shipped from the Company's warehouse. The Company sells its products primarily through commission sales representatives in the United States and distributors in foreign countries. In cases where the Company utilizes distributors, it recognizes revenue upon shipment, provided that all other revenue recognition criteria have been met, and ownership risk has transferred. Allowance for Doubtful Accounts The Company maintains allowances for doubtful accounts for estimated losses resulting from the inability of the Company's customers to make required payments. The allowance for doubtful accounts is based on specific identification of customer accounts and the Company's best estimate of the likelihood of potential loss, taking into account such factors as the financial condition and payment history of major customers. The Company evaluates the collectibility of our receivables at least quarterly. If the financial condition of the Company's customers were to deteriorate, resulting in an impairment of their ability to make payments, additional allowances may be required. The differences could be material and could significantly impact cash flows from operating activities. Goodwill Goodwill represents the excess of the cost over the acquired assets of MST. On October 1, 2002, the Company adopted the provisions of Statement of Financial Accounting Standards ("SFAS") No. 142, "Goodwill and Other Tangible Assets." As a result of adoption SFAS No. 142, the Company's goodwill is no longer amortized, but is subject to an annual impairment test, or whenever events or changes in circumstances indicate that the carrying value may not be recoverable. There was no impairment of goodwill at December 31, 2003. Deferred Taxes The Company records a valuation allowance to reduce the deferred tax assets to the amount that is more likely than not to be realized. The Company has considered estimated future taxable income and ongoing tax planning strategies in assessing the amount needed for the valuation allowance. Based on these estimates, all of the Company's deferred tax assets have been reserved. If actual results differ favorably from those estimates used, the Company may be able to realize all or part of the Company's net deferred tax assets. Such realization could positively impact our operating results and cash flows from operating activities. Stock Option Plans The Company accounts for its stock-based compensation plans under the recognition and measurement principles of Accounting Principles Board Opinion No. 25, "Accounting for Stock Issued to Employees," and related interpretations. The Company has adopted the disclosure provisions of SFAS No. 123, "Accounting for Stock-Based Compensation," as amended by SFAS No. 148, "Accounting for Stock-Based Compensation - Transition and Disclosure" - an amendment of FASB Statement No. 123. RESULTS OF OPERATIONS The statements contained in this Quarterly Report on Form 10-QSB that are not historical facts may contain forward-looking statements that involve a number of known and unknown risks and uncertainties that could cause actual results to differ materially from those discussed or anticipated by management. Potential risks and uncertainties include, among other factors, general business conditions, government regulations governing medical device approvals and manufacturing practices, competitive market conditions, success of the Company's business strategy, delay of orders, changes in the mix of products sold, availability of suppliers, concentration of sales in markets and to certain customers, changes in manufacturing efficiencies, development and introduction of new products, fluctuations in margins, timing of significant orders, and other risks and uncertainties currently unknown to management. 12 Method of Presentation The consolidated financial statements include the accounts of the Trimedyne, Inc., its wholly owned subsidiary Mobile Surgical Technologies, Inc. ("MST") and its 90% owned subsidiary, Cardiodyne, Inc. ("Cardiodyne"). Quarter ended December 31, 2003 compared to quarter ended December 31, 2002 During the quarter ended December 31, 2003, net revenues were $1,380,000 as compared to $1,685,000 for the same period of the previous year, a $305,000 or 18% decrease. This overall decrease was the result of lower laser sales during the current period. Lasers typically sell between $35,000 and $120,000, depending upon the type of laser, and the quantity sold in a typical quarter during the past two years has ranged from one to six per quarter. During the quarter ended December 31, 2003, the Company only sold one laser, or two units less than average per quarter in the last two years. Net sales from delivery and disposable devices increased by $33,000 or 4% to $881,000 in the current quarter from $848,000 in the same quarter of the prior year. Net sales from service and rental increased by $17,000 or 4% to $415,000 from $398,000 for the same quarters. This increase was primarily due to the growth of the Company's subsidiary MST. Cost of goods sold remained unchanged at 51% of net sales in the first quarter of fiscal 2003 compared to the first quarter of fiscal 2002. Selling, general and administrative expenses increased in the current quarter to $567,000 from $475,000 in the prior year quarter, an increase of $92,000 or 19%. The increase in selling, general and administrative expenses is the result of Trimedyne being named in an additional product liability lawsuit and accruing a charge of $50,000 representing the contingency for insurance deductible combined with a rent increase of $11,000 per the leasing contract of the Company's Irvine location and a $12,000 increase in salaries and wages due to the hiring of additional operations staff. Research and development expenditures for the quarter ended December 31, 2003, remained unchanged at $67,000 as compared to the quarter ended December 31, 2002. Other income increased by $114,000 or 1,267% from income of $9,000 in the first quarter of fiscal 2002 to income of $123,000 in the first quarter of 2003. During the three months ended December 31, 2003, the Company settled litigation with a competitor which resulted in the reduction of $88,000 in liability for royalties and the receipt of a $53,000 cash insurance settlement for a damaged laser offset by interest accrued on notes due to the CEO. For the current quarter, the Company had net income of $165,000 or $0.01 per share, based on 14,473,764 basic weighted average number of common shares outstanding, as compared to net income of $290,000, or $0.02 per share, based on 13,729,760 basic weighted average number of common shares outstanding in the same quarter of the previous year, resulting from the above mentioned factors. Liquidity and Capital Resources - ------------------------------- At December 31, 2003, the Company had working capital of $2,596,000 compared to $1,312,000 at the end of the first quarter ending December 31, 2002. Cash decreased by $30,000 to $1,316,000 from $1,346,000 at the fiscal year ending September 30, 2003. We believe our existing working capital will be sufficient to meet Trimedyne's operating needs, and the operating needs of our 100% owned laser rental subsidiary for the next twelve months. During the period ending December 31, 2003, MST generated approximately $16,000 in cash flows from operations. While we expect to continue to operate at a profit, we could incur losses in the future if we fail to generate revenues sufficient to offset the costs associated with manufacturing and marketing our current products, our overhead, and the development of new products. If we fail to continue to operate profitability, or if we undertake the development, testing and marketing of new products in the future, we will likely need to raise substantial additional capital. There can be no assurance that we will be able to operate profitably in the future. We have $200,000 of Senior Convertible Notes due to our chief executive officer (the "Notes") outstanding which are due, with interest at 12% per annum, in 2007. The Notes and accrued interest are convertible at prices of $0.40 and $0.50 per share. If the Notes and accrued interest are not converted, we may have to raise additional capital to pay the Note holder the principal and interest due on the Notes. Sources of such financing may include the sale of additional equity securities or the sale or licensing of patent rights. The issuance of additional common stock or shares of preferred stock will dilute the equity interests of our shareholders. There is no assurance such financing, if and when needed, will be available to us on acceptable terms. 13 Item 3. Controls and Procedures Evaluation of Disclosure Controls and Procedures The Company's chief executive officer and chief financial officer carried out an evaluation of the effectiveness and operation of the Company's disclosure controls and procedures. They have concluded after evaluating the effectiveness of the Company's disclosure controls and procedures as of a date (the "Evaluation Date") within 90 days before the filing date of this quarterly report, that as of the Evaluation Date, the Company's disclosure controls and procedures were effective and designed to ensure that material information relating to the Company would be made known to them by others. Changes in Internal Controls There have been no significant changes in the Company's internal controls or in other factors that could significantly affect those controls subsequent to the Evaluation Date. 14 Part II Other Information Item 1. Legal Proceedings The Company was a defendant and counterclaimant in Lumenis, Inc. ("Lumenis") v. Trimedyne, Inc. Lumenis alleged that the Company had infringed on two of its patents. The Company filed an answer to Lumenis' complaint and also filed counterclaims against Lumenis alleging infringement of two of the Company's patents, unfair business practices, libel and anti-trust violations. The Company was a party to a license agreement (the "License Agreement"), which required it to pay royalties to Lumenis. At September 30, 2003, the Company had accrued royalties under this license agreement in the amount of $88,000, which were in dispute. On November 25, 2003, the Company and Lumenis entered into a settlement agreement (the "Settlement Agreement"), under which the court dismissed the litigation between them. The Settlement Agreement also provided that Lumenis would apply a credit to royalties due by the Company under the License Agreement, and pay the Company $5,000 for the remaining overpayment of royalties due under the License Agreement. The Settlement Agreement also provided that the Company and Lumenis would enter into an original equipment manufacture ("OEM") agreement whereby Lumenis would pay the Company a technology access fee of $150,000 and purchase from the Company certain side-firing and angled-firing fiber optic devices, which Lumenis will market with its lasers, plus an amount equal to 7.5% of Lumenis' sales of side-firing and angled-firing devices manufactured by Lumenis or purchased by Lumenis from third-party suppliers. On January 30, 2004, the Company received $155,000 in connection with the terms of the Settlement Agreement, which will be recorded as other income in the subsequent period. The Company is currently a defendant in three product liability lawsuits. These cases relate to injuries that occurred in connection to medical procedures in which the Company's lasers were used. All of these cases are currently in litigation. The Company has insurance to cover product liability claims. This insurance provides the Company with $5,000,000 of coverage for each occurrence with a general aggregate of $5,000,000. Trimedyne's liability is limited to a maximum of $50,000 per occurrence unless the judgment against the Company exceeds the insurance coverage. In such case, Trimedyne would be liable for any liability in excess of $5,000,000. Management has recorded a loss contingency for these claims in the amount of $100,000 ($50,000 for each claim), based on the deductible under the insurance policy. In one product liability lawsuit, the cost of defense has exceeded the insurance deductible that was accrued in prior periods. Management is not accruing any additional provision for this claim, as it is not expected that this claim will exceed the limits of the insurance coverage. Item 2. Changes in Securities None Item 3. Defaults Upon Senior Securities None Item 4. Submission of Matters to Vote of Security Holders None Item 5. Other Information None Item 6. Exhibits and Reports on Form 8-K (a) Exhibits 99.1 Officer Certification 99.2 Controller Certification (b) Reports on Form 8-K None 15 SIGNATURE PAGE 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 hereunto duly authorized. TRIMEDYNE, INC. Date: February 23, 2004 /s/ Marvin P. Loeb -------------------------- ------------------------------------ Marvin P. Loeb President and Chief Executive Officer Date: February 23, 2004 /s/ Jeffrey S. Rudner -------------------------- ------------------------------------ Jeffrey S. Rudner Controller 16 CERTIFICATION I, Marvin P. Loeb, hereby certify that: 1. I have reviewed this quarterly report on Form 10-QSB of Trimedyne, Inc.; 2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact, or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; and 3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial position, results of operations, and cash flows of the issuer as of, and for, the periods presented in this quarterly report. 4. I am responsible for establishing and maintaining disclosure controls and procedures for the issuer and have: (i) Designed such disclosure controls and procedures to ensure that material information relating to the issuer is made known to me, particularly during the period in which the periodic reports are being prepared; (ii) Evaluated the effectiveness of the issuer's disclosure controls and procedures as of December 31, 2003; and (iii) Presented in the report our conclusions about the effectiveness of the disclosure controls and procedures based on my evaluation as of the Evaluation Date; 5. I have disclosed, based on my most recent evaluation, to the issuer's auditors and the audit committee of the board of directors (or persons fulfilling the equivalent function): (i) All significant deficiencies in the design or operation of internal controls which could adversely affect the issuer's ability to record, process, summarize and report financial data and have identified for the issuer's auditors any material weaknesses in internal controls; and (ii) Any fraud, whether or not material, that involves management or other employees who have a significant role in the issuer's internal controls; and 6. I have indicated in the report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. Date: February 23, 2004 /s/ Marvin P. Loeb - ------------------------ Marvin P. Loeb, CEO 17 CERTIFICATION I, Jeffrey Rudner, hereby certify that: 1. I have reviewed this quarterly report on Form 10-QSB of Trimedyne, Inc.; 2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact, or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; and 3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial position, results of operations, and cash flows of the issuer as of, and for, the periods presented in this quarterly report. 4. I am responsible for establishing and maintaining disclosure controls and procedures for the issuer and have: a. Designed such disclosure controls and procedures to ensure that material information relating to the issuer is made known to me, particularly during the period in which the periodic reports are being prepared; b. Evaluated the effectiveness of the issuer's disclosure controls and procedures as of December 31, 2003; and c. Presented in the report our conclusions about the effectiveness of the disclosure controls and procedures based on my evaluation as of the Evaluation Date; 5. I have disclosed, based on my most recent evaluation, to the issuer's auditors and the audit committee of the board of directors (or persons fulfilling the equivalent function): a. All significant deficiencies in the design or operation of internal controls which could adversely affect the issuer's ability to record, process, summarize and report financial data and have identified for the issuer's auditors any material weaknesses in internal controls; and b. Any fraud, whether or not material, that involves management or other employees who have a significant role in the issuer's internal controls; and 6. I have indicated in the report whether or not there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. Date: February 23, 2004 /s/ Jeffrey Rudner - ------------------------ 18 EX-99.1 3 trimedyne_10qex99-1.txt EXHIBIT 99.1 CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the quarterly filing of Trimedyne, Inc., a Nevada corporation (the "Company"), on Form 10-QSB for the period ended December 31, 2003, as filed with the Securities and Exchange Commission (the "Report"), the undersigned, Marvin P. Loeb, the Chief Executive Officer of the Company, hereby certifies, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C.ss.1350), that: (1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. Dated: February 23, 2004 /s/ Marvin P. Loeb - ------------------------ 19 EX-99.2 4 trimedyne_10qex99-2.txt EXHIBIT 99.2 CERTIFICATION PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 In connection with the quarterly filing of Trimedyne, Inc., a Nevada corporation (the "Company"), on Form 10-QSB for the period ended December 31, 2003, as filed with the Securities and Exchange Commission (the "Report"), the undersigned, Jeffrey Rudner, the Controller of the Company, hereby certifies, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002 (18 U.S.C.ss.1350), that: (1) The Report fully complies with the requirements of section 13(a) or 15(d) of the Securities Exchange Act of 1934; and (2) The information contained in the Report fairly presents, in all material respects, the financial condition and results of operations of the Company. Dated: February 23, 2004 /s/ Jeffrey Rudner - ------------------------ Jeffrey Rudner, Chief Accounting Officer 20 -----END PRIVACY-ENHANCED MESSAGE-----