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 June 30, 2005 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 August 15, 2005 ---------------------------- ------------------------------------ Common Stock, $.01 par value 14,602,931 shares ITEM 1. 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 14 ITEM 3. Controls and Procedures 17 PART II. Other Information 18 SIGNATURE PAGE 19 CERTIFICATIONS 20 2 TRIMEDYNE, INC. CONSOLIDATED BALANCE SHEET (UNAUDITED) ASSETS June 30, 2005 ------------ Current assets: Cash and cash equivalents $ 1,517,000 Trade accounts receivable, net of allowance for doubtful accounts of $86,000 801,000 Inventories 2,210,000 Other 122,000 ------------ Total current assets 4,650,000 Property and equipment, net 386,000 Goodwill 544,000 Other assets 90,000 ------------ $ 5,670,000 ============ LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable $ 472,000 Accrued expenses 456,000 Deferred revenue 49,000 Accrued warranty 54,000 Income tax payable 14,000 Notes payable and current portion of long-term debt 70,000 ------------ Total current liabilities 1,115,000 Senior convertible secured notes due to officer 200,000 Accrued interest due officer 80,000 Long-term debt, net of current portion 5,000 ------------ Total liabilities 1,400,000 ------------ Commitments and contigencies 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, 14,704,540 shares issued, 14,602,931 shares outstanding 148,000 Capital in excess of par value 47,945,000 Accumulated deficit (43,110,000) ------------ 4,983,000 Treasury stock, at cost (101,609 shares) (713,000) ------------ Total stockholders' equity 4,270,000 ------------ $ 5,670,000 ============ See accompanying notes to consolidated financial statements 3 TRIMEDYNE, INC. CONSOLIDATED STATEMENTS OF INCOME (UNAUDITED) Three Months Ended Nine Months Ended June 30, June 30, 2005 2004 2005 2004 ------------ ------------ ------------ ------------ Net revenues $ 1,552,000 $ 1,696,000 $ 4,783,000 $ 4,350,000 Cost of revenues 918,000 864,000 2,535,000 2,232,000 ------------ ------------ ------------ ------------ Gross profit 634,000 832,000 2,248,000 2,118,000 Operating expenses: Selling, general and administrative 657,000 578,000 1,912,000 1,685,000 Research and development 180,000 84,000 457,000 245,000 ------------ ------------ ------------ ------------ Total operating expenses 837,000 662,000 2,369,000 1,930,000 ------------ ------------ ------------ ------------ Income (loss) from operations (203,000) 170,000 (121,000) 188,000 Other income, net 54,000 13,000 125,000 313,000 ------------ ------------ ------------ ------------ Income (loss) before income taxes (149,000) 183,000 4,000 501,000 Provision for income taxes 4,000 25,000 8,000 29,000 ------------ ------------ ------------ ------------ Net income (loss) $ (153,000) $ 158,000 $ (4,000) $ 472,000 ============ ============ ============ =========== Net income (loss)per share: Basic $ (0.01) $ 0.01 $ -- $ 0.03 ============ ============ ============ ============ Diluted $ (0.01) $ 0.01 $ -- $ 0.03 ============ ============ ============ ============ Weighted average number of shares outstanding: Basic 14,602,931 14,597,876 14,602,931 14,548,428 ============ ============ ============ ============ Diluted 14,602,931 15,493,036 14,602,931 15,478,849 ============ ============ ============ ============ See accompanying notes to consolidated financial statements. 4 TRIMEDYNE, INC. CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED) Nine Months Ended June 30, 2005 2004 ----------- ---------- Cash flows from operating activities: Net income (loss) $ (4,000) $ 472,000 Adjustment to reconcile net income (loss) to net cash provided by (used in) operating activities: Depreciation and amortization 105,000 189,000 Loss on disposal of property and equipment 3,000 5,000 Changes in operating assets and liabilities: Accounts receivable (8,000) (457,000) Inventories (246,000) (126,000) Other assets 17,000 53,000 Accounts payable 75,000 4,000 Accrued expenses (57,000) (77,000) Deferred revenue (2,000) 15,000 Accrued warranty 10,000 (4,000) Accrued interest due to officer 18,000 18,000 Income tax payable (5,000) 14,000 ----------- ----------- Net cash provided by (used in) operating activities (94,000) 106,000 ----------- ----------- Cash flows from investing activities: Purchase of property and equipment (75,000) (83,000) ----------- ----------- Net cash used in investing activities (75,000) (83,000) ----------- ----------- Cash from financing activities: Exercise of stock options -- 70,000 Issuance of notes payable 110,000 -- Payments on debt (107,000) (116,000) ----------- ----------- Net cash provided by (used in) financing activities 3,000 (46,000) ----------- ----------- Net decrease in cash and cash equivalents (166,000) (23,000) Cash and cash equivalents at beginning of period 1,683,000 1,346,000 ----------- ----------- Cash and cash equivalents at end of period $ 1,517,000 $ 1,323,000 =========== =========== Cash paid for interest and income taxes was insignificant in 2005 and 2004. See accompanying notes to consolidated financial statements 5 TRIMEDYNE, INC. NOTES TO CONSOLIDATED FINANCIAL STATEMENTS JUNE 30, 2005 and 2004 (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 June 30, 2005 and the results of its operations and its cash flows for the three months and nine months ended June 30, 2005 and 2004. Results for the nine months ended June 30, 2005 are not necessarily indicative of the results to be expected for the year ending September 30, 2005. 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 2005 Annual Report on Form 10-KSB. 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 104, "Revenue Recognition," 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. Revenues from the rental of equipment is recognized over the rental period. Revenues from service contracts are recognized monthly throughout the term of the service agreement. 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 adopting 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 June 30, 2005. 6 Impairment of Long-Lived Assets SFAS No. 144, "Accounting for Impairment or Disposal of Long-Lived Assets", requires that long-lived assets, such as property and equipment and purchased intangibles subject to amortization, be reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount of an asset may not be recoverable. Recoverability of the asset is measured by comparison of its carrying amount to undiscounted future net cash flows the asset is expected to generate. If such assets are considered to be impaired, the impairment to be recognized is measured as the amount by which the carrying amount of the asset exceeds its fair market value. Estimates of expected future cash flows represent management's best estimate based on currently available information and reasonable and supportable assumptions. Any impairment recognized in accordance with SFAS 144 is permanent and may not be restored. To date, the Company has not recognized any impairment of long-lived assets in connection with SFAS 144. Stock Option Plans SFAS No. 123, "Accounting for Stock-Based Compensation," as amended by SFAS No. 148, "Accounting for Stock-Based Compensation - Transition and Disclosure," prescribes accounting and reporting standards for all stock-based compensation plans, including employee stock option plans. As allowed by SFAS No. 123, the Company has elected to continue to account for its employee stock-based compensation plan using the intrinsic value method in accordance with Accounting Principles Board (APB) Opinion No. 25, "Accounting for Stock Issued to Employees," and related Interpretations, which does not require compensation to be recorded if the consideration to be received is at least equal to the fair value of the common stock to be received at the measurement date. Under the requirements of SFAS No. 123, non-employee stock-based transactions require compensation to be recorded based on the fair value of the securities issued or the services received, whichever is more reliably measurable. The following table illustrates the effect on net income (loss) and net income (loss) per share if the Company had applied the fair value recognition provisions of SFAS No. 123 to stock-based employee compensation: Three months ended Nine months ended June 30, June 30, 2005 2004 2005 2004 --------- --------- --------- --------- Net income (loss), as reported $(153,000) $ 158,000 $ (4,000) $ 472,000 Deduct: total stock-based employee compensation expense determined under fair value based method for awards, net of related tax effects (61,000) (29,000) (99,000) (39,000) --------- --------- --------- --------- Pro forma net income (loss) $(214,000) $ 129,000 $(103,000) $ 433,000 ========= ========= ========= ========= Net income (loss) per share - basic: As reported $ (0.01) $ 0.01 $ -- $ 0.03 ========= ========= ========= ========= Pro forma $ (0.01) $ 0.01 $ (0.01) $ 0.03 ========= ========= ========= ========= Net income (loss) per share - diluted: As reported $ (0.01) $ 0.01 $ -- $ 0.03 ========= ========= ========= ========= Pro forma $ (0.01) $ 0.01 $ (0.01) $ 0.03 ========= ========= ========= ========= 7 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: Three months ended Nine months ended June 30, June 30, 2005 2004 2005 2004 ---------- ---------- ---------- ---------- Dividend yield -- -- -- -- Expected volatility 80% 80% 80% 80% Risk-free interest rate 3.47% 2.11% 3.47% 2.11% Expected lives 5 years 5 years 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. Use of Estimates The preparation of financial statements in conformity with accounting principles generally accepted in the United States requires management to make certain estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Significant estimates and assumptions include inventory valuation, allowances for doubtful accounts and deferred income tax assets, recoverability of goodwill and long-lived assets, losses for contingencies and certain accrued liabilities. Fair Value of Financial Instruments The Company's financial instruments consist primarily of cash and cash equivalents, accounts receivable, accounts payable, accrued expenses, notes payable and long-term debt, and two senior convertible secured notes due to the Chief Executive Officer. The carrying amounts of the Company's financial instruments generally approximate their fair values as of June 30, 2005 because of the short maturity of these instruments. Senior convertible secured notes due to officer cannot be objectively and fairly valued due to the related party nature of the instrument. Warranty Costs The Company provides warranties for certain products and maintains warranty reserves for estimated product warranty costs at the time of sale. At June 30, 2005, the Company has accrued $54,000 for estimated future warranty costs. Warranty activity for the periods presented was not significant. Research and Development Costs All research and development costs, including licensing costs, are charged to expense as incurred. In accordance with this policy, all costs associated with the design, development and testing of the Company's products have been expensed as incurred. Related Party Transactions During the second quarter ended March 31, 2005, a member of the board of directors was engaged as a consultant to MST, Inc. to faciliate increases to administrative efficiency. The Company recorded $31,000 and $52,000 in consulting expenses associated with the arrangement which was included in adminstrative expense for the three and nine months periods ended June 30, 2005, respectively. The consulting services are not expected to be extended beyond a one year period. Recently Issued Accounting Pronouncements In November 2004, the FASB issued SFAS No. 151 "Inventory Costs, an amendment of ARB No. 43, Chapter 4." The amendments made by Statement 151 clarify that abnormal amounts of facility expense, freight, handling costs, and wasted materials (spoilage) should be recognized as current-period charges and require the allocation of fixed production overheads to inventory based on the normal capacity of the production facilities. The guidance is effective for inventory costs incurred during fiscal years beginning after June 15, 2005. Earlier application is permitted for inventory costs incurred during fiscal years beginning after November 23, 2004. The Company is in the process of evaluating whether the adoption of SFAS No. 151 will have a significant impact on the Company's overall results of operations or financial position. 8 In December 2004, the FASB issued SFAS No. 123 (revised 2004), "Share-Based Payment." SFAS No. 123(R) will provide investors and other users of financial statements with more complete and neutral financial information by requiring that the compensation cost relating to share-based payment transactions be recognized in financial statements. That cost will be measured based on the fair value of the equity or liability instruments issued. SFAS No. 123(R) covers a wide range of share-based compensation arrangements including share options, restricted share plans, performance-based awards, share appreciation rights, and employee share purchase plans. SFAS No. 123(R) replaces SFAS No. 123, and supersedes APB Opinion No. 25. SFAS No. 123, as originally issued in 1995, established as preferrable a fair-value-based method of accounting for share-based payment transactions with employees. However, SFAS No. 123 permitted entities the option of continuing to apply the guidance in Opinion 25, as long as the footnotes to financial statements disclosed what net income would have been had the preferable fair-value-based method been used. The Company will be required to apply SFAS No. 123(R) in fiscal 2007.The Company is in the process of evaluating whether the adoption of SFAS No. 123(R) will have a significant impact on the Company's overall results of operations or financial position. NOTE 2 - Balance Sheet Items June 30, 2005 ----------- Inventories consist of the following: Raw material $ 929,000 Work-in-process 570,000 Finished goods 995,000 ----------- 2,494,000 Less inventory reserve (284,000) ----------- $ 2,210,000 =========== Other current assets consist of the following: Prepaid insurance $ 108,000 Other 14,000 ----------- Total other current assets $ 122,000 =========== Property and equipment consist of the following: Furniture and equipment $ 2,458,000 Leasehold improvements 214,000 Other 233,000 ----------- 2,905,000 Less accumulated depreciation and amortization (2,519,000) ----------- Total property and equipment, net $ 386,000 =========== Accrued expenses consist of the following: Loss contingency $ 36,000 Accrued salaries and wages 32,000 Accrued vacation 113,000 Accrued compensation 18,000 Sales and use tax 38,000 Customer deposits 133,000 Accrued professional expenses 56,000 Accrued commissions 20,000 Accrued payroll taxes 3,000 Other 7,000 ----------- Total accrued expenses $ 456,000 =========== 9 NOTE 3 - Notes Payable and Long-Term Debt Loan payable to leasing company, bearing interest at 8% per annum; principal and interest due monthly in equal installments of $211 through May 2008. The loan is secured by the related forklift. $ 7,000 Notes payable to finance company, issued in conection with financing certain insurance policies. The notes bear interest at 5.98% per annum and require monthly principal and interest payments of $9,732 through January 2006. 68,000 ------------ $ 75,000 Less: current portion (70,000) ----------- $ 5,000 =========== NOTE 4 - Convertible Notes Due to Officer At June 30, 2005, the Company had two outstanding senior convertible notes due to its chief executive officer. These notes mature, with interest at 12% per annum, in February and April 2007, and are convertible at prices of $0.40 and $0.50 per share. These convertible notes are secured by substantially all of the Company's assets. $ 200,000 =========== Accrued interest on these notes was $80,000 at June 30, 2005. NOTE 5 - Income (Loss) Per Share Information Basic income (loss) 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 officer 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 income (loss) per share: Three months ended Nine months ended June 30, June 30, -------------------------- -------------------------- 2005 2004 2005 2004 ---------- ---------- ------------ ----------- Denominator Weighted average common shares outstanding used in calculating basic earnings per share 14,602,931 14,597,876 14,602,931 14,548,428 Effect of dilutive options *(1) 287,660 *(2) 322,921 Effect of senior convertible secured notes due to officer and accrued interest *(1) 607,500 *(2) 607,500 ---------- ---------- ---------- ---------- Weighted average common shares outstanding used in calculating diluted earnings per share 14,602,931 15,493,036 14,602,931 15,478,849 ========== ========== ========== ========== Numerator Net income (loss) $ (153,000) $ 158,000 $ (4,000) $ 472,000 Add - interest on senior convertible secured notes due to officer *(1) 6,000 *(2) 18,000 ----------- ----------- ---------- ---------- Net income (loss) available to common stockholders $ (153,000) $ 164,000 $ (4,000) $ 490,000 =========== =========== ========== =========== (1) The effects are anti-dilutive, and therefore, they are not considered in the calculation of diluted income (loss) per share. Note: had the effect of the dilutive options and convertible debt outstanding been added to the diluted weighted-average common shares outstanding, the diluted common shares outstanding would have been 703,579 greater. (2) The effects are anti-dilutive, and therefore, they are not considered in the calculation of diluted income (loss) per share. Note: had the effect of the dilutive options and convertible debt outstanding been added to the diluted weighted-average common shares outstanding, the diluted common shares outstanding would have been 717,829 greater. 10 NOTE 6 - Contingencies: Litigation On November 17, 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, which the Company had accrued, 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. The above technology fee and royalties were received during the fiscal year ended September 30, 2004 and royalties are currently being received per the above agreement and included in other income for the current three and nine month periods ended June 30, 2005 (see Note 7). Product liability The Company is currently a defendant in one product liability lawsuit. This case relates to injuries that occurred in connection with medical procedures in which the Company's laser was used. 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. Trimedyne would be liable for any judgement in excess of $5,000,000. At June 30, 2005, the Company accrued $50,000 as a loss contigency on this claim, based on the deductible under the insurance policy, of which $14,000 was paid in attorney fees as of June 30, 2005. 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 one license agreement with a competitor under which royalties have been waived. 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. Guarantees and Indemnities The Company has made certain indemnities and guarantees, under which it may be required to make payments to a guaranteed or indemnified party. The Company indemnifies its directors, officers, employees and agents to the maximum extent permitted under the laws of the State of California. In connection with its facility leases, the Company has indemnified its lessors for certain claims arising from the use of the facilities. The duration of the guarantees and indemnities varies, and in many cases is indefinite. These guarantees and indemnities do not provide for any limitation of the maximum potential future payments the Company could be obligated to make. Historically, the Company has not been obligated to make any payments for these obligations and no liabilities have been recorded for these indemnities and guarantees in the accompanying consolidated balance sheet. 11 NOTE 7 - Other Income During the nine months ended June 30, 2005, the Company received $133,000 in royalties in connection with the terms of the above Settlement Agreement (see Note 6), which is included in other income for the nine month period ended June 30, 2005. During the nine months ended June 30, 2004, the Company settled litigation with Lumenis which resulted in a reduction of $88,000 previously accrued for royalties. In January and March 2004, the Company received $155,000 in technology fees and $26,000 in royalties, respectively, in connection with the terms of the above settlement, which is included in other income for the nine month period ended June 30, 2004 (see Note 6). The Company also received $53,000 from an insurance settlement for a damaged laser. NOTE 8 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 and nine months ended June 30, 2005 and June 30, 2004 are as follows (unaudited): For the quarter ended June 30, 2005 For the quarter ended June 30, 2004 Service and Service and Products Rental Total Products Rental Total ---------------------------------------- ---------------------------------------- Net revenues $ 1,194,000 $ 358,000 $ 1,552,000 $ 1,294,000 $ 402,000 $ 1,696,000 Cost of revenues 649,000 269,000 918,000 634,000 230,000 864,000 ---------------------------------------- --------------------------------------- Gross profit 545,000 89,000 634,000 660,000 172,000 832,000 Operating expenses: Selling, general and administrative 533,000 124,000 657,000 452,000 126,000 578,000 Research and development 180,000 -- 180,000 84,000 -- 84,000 ---------------------------------------- --------------------------------------- (Loss) income from operations $ (168,000) $ (35,000) (203,000) $ 124,000 $ 46,000 170,000 ========================== ========================= Other income (expense): Interest income 4,000 2,000 Interest expense (9,000) (8,000) Royalty income 52,000 19,000 Settlements and recoveries 7,000 -- Income taxes (4,000) (25,000) ------------ ---------- Net (loss) income $ (153,000) $ 158,000 ============ ========== For the nine months ended June 30, 2005 For the nine months ended June 30, 2004 Service and Service and Products Rental Total Products Rental Total ---------------------------------------- ---------------------------------------- Net revenues $ 3,615,000 $ 1,168,000 $ 4,783,000 $ 3,096,000 $ 1,254,000 $ 4,350,000 Cost of revenues 1,704,000 831,000 2,535,000 1,488,000 744,000 2,232,000 ---------------------------------------- ---------------------------------------- Gross profit 1,911,000 337,000 2,248,000 1,608,000 510,000 2,118,000 Operating expenses: Selling, general and administrative 1,524,000 388,000 1,912,000 1,256,000 429,000 1,685,000 Research and development 457,000 -- 457,000 245,000 -- 245,000 ---------------------------------------- ---------------------------------------- (Loss) income from operations $ (70,000) $ (51,000) (121,000) $ 107,000 $ 81,000 188,000 ========================== ========================= Other income (expense): Interest income 11,000 4,000 Interest expense (24,000) (27,000) Loss on disposal of equipment (3,000) (5,000) Royalty income 133,000 45,000 Settlements and recoveries 8,000 296,000 Income taxes (8,000) (29,000) ------------ ---------- Net (loss) income $ (4,000) $ 472,000 ============ ========== 12 Sales and gross profit to customers by similar products and services for the three and nine months ended June 30, 2005 and June 30, 2004 were as follows (unaudited): For the three months ended June 30, For the nine months ended June 30, 2005 2004 2005 2004 ----------- ----------- ----------- ----------- By similar products and services: Revenues: Products: Laser equipment and accessories $ 405,000 $ 406,000 $ 1,241,000 $ 595,000 Delivery and disposable devices 789,000 888,000 2,374,000 2,501,000 Service and rental 358,000 402,000 1,168,000 1,254,000 ---------- ---------- ------------ ----------- Total $1,552,000 $1,696,000 $ 4,783,000 $ 4,350,000 ========== ========== ============ =========== Gross profit Products: Laser equipment and accessories $ 95,000 $ 155,000 $ 380,000 $ 200,000 Delivery and disposable devices 450,000 505,000 1,531,000 1,408,000 Service and rental 89,000 172,000 337,000 510,000 ---------- ---------- ------------ ----------- Total $ 634,000 $ 832,000 $ 2,248,000 $ 2,118,000 ========== ========== ============ =========== The Company's revenue base is derived from the sales of medical products and services on a worldwide basis originating from the United States. 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. Sales in foreign countries for the quarters ended June 30, 2005 and June 30, 2004 accounted for approximately 22% and 8% of the Company's total sales, respectively. Sales in foreign countries for the nine months ended June 30, 2005 and June 30, 2004 accounted for approximately 18% and 10% of the Company's total sales, respectively. The breakdown by geographic region is as follows: Three months Three months Nine months Nine months ended June ended June ended June ended June 30, 2005 30, 2004 30, 2005 30, 2004 ------------ ----------- ------------ ------------ Asia $ 299,000 $ 325,000 $ 800,000 $ 497,000 Europe 37,000 131,000 320,000 328,000 Latin America 2,000 5,000 86,000 14,000 Middle East 1,000 5,000 1,000 17,000 Other 25,000 -- 29,000 11,000 ------------ ----------- ------------ ------------ $ 364,000 $ 466,000 $ 1,236,000 $ 867,000 ============= =========== ============ ============ All long-lived assets were located in the United States during the three and nine months ended June 30, 2005 and 2004. 13 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION CRITICAL ACCOUNTING POLICIES Revenue Recognition In accordance with Staff Accounting Bulletin 104, "Revenue Recognition," 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 its 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. 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-based Compensation The Company accounts for its employee 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. 14 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. 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 June 30, 2005 compared to quarter ended June 30, 2004: During the quarter ended June 30, 2005, net revenues were $1,552,000 as compared to $1,696,000 for the same period of the previous year, a $144,000 or 8% decrease. Net revenues from delivery and disposable devices decreased by $99,000 or 11% to $789,000 in the current quarter from $888,000 in the same quarter of the prior year. Net revenues from service and rental decreased by $44,000 or 11% to $358,000 from $402,000 for the same quarters. This decrease was primarily due to the decrease in billable service for the current quarter. Cost of revenues during the quarter ended June 30, 2005 was 59% of net revenues as compared to 50% of net revenues during the quarter ended June 30, 2004. This increase was primarily due to a decrease in service revenue while maintaining current service staffing costs, which resulted in higher cost per service call, combined with additional periodic maintenance of rental inventory for our service subsidiary, Mobile Surgical Technologies, Inc. Selling, general and administrative expenses increased in the current quarter to $657,000 from $578,000 in the prior year quarter, an increase of $79,000 or 13%. The increase in selling, general and administrative expenses was primarily the result of the following: the loss of $45,000 in rental income from a subtenant whose lease terminated in June 2004 which offset rent expense, and $31,000 in consultant fees (see Related Party Transactions). Research and development expenses increased in the current quarter to $180,000 from $84,000 in the prior year quarter, an increase of $96,000 or 114%. This increase was a result of Trimedyne increasing its efforts to improve and develop new delivery systems through an increase in staff. Other income, net increased by $41,000 or 315% to $54,000 in the third quarter of fiscal 2005 from $13,000 in the third quarter of 2004. During the three months ended June 30, 2005, the Company received $52,000 in royalties in connection with the terms of a settlement with a competitor (see Note 6). For the current quarter, the Company had a net loss of $153,000 or $(0.01) per share, based on 14,602,931 basic weighted average number of common shares outstanding, as compared to net income of $158,000, or $0.01 per share, based on 14,597,876 basic weighted average number of common shares outstanding in the same quarter of the previous year, resulting from the above mentioned factors. Nine months ended June 30, 2005 compared to nine months ended June 30, 2004: During the nine months ended June 30, 2005, net revenues were $4,783,000 as compared to $4,350,000 for the same period of the previous year, a $433,000 or 10% increase. Net revenues from lasers and accessories increased by $646,000 or 209% to $1,241,000 during the nine months ended June 30, 2005 from $595,000 in the the same period of the prior year. Net revenues from delivery and disposable devices decreased by $127,000 or 5% to $2,374,000 during the nine months ended June 30, 2005 from $2,501,000 for the same period of the prior year. Net revenues from service and rental decreased by $86,000 or 7% to $1,168,000 from $1,254,000 for the same quarters in the prior year, which was primarily due to a decrease in billable service calls combined with a decrease in laser service rental fees from MST. Cost of revenues increased to 53% of net sales in the nine months ended June 30, 2005 compared to 51% for the nine months ended June 30, 2004. This increase was primarily due to a decrease in service revenue while maintaining current service staffing costs, which resulted in higher cost per service call. 15 For the nine months ended June 30, 2005, selling, general and administrative expenses totaled $1,912,000 as compared to $1,685,000 for the same period of the previous year, a $148,000 or 13% increase. This increase in selling, general and administrative expenses since the prior year period is primarily the result of the loss of $152,000 in rental income from a subtenant whose lease terminated in June 2004 which offset rent expense and $52,000 in consultant expenses incurred by MST, Inc. (see Related Party Transactions) offset by a decrease in administrative salaries of $37,000 and a decrease in marketing expenses of $18,000. During the nine months ended June 30, 2005, research and development expenses increased to $457,000 from $245,000 in the prior year nine month period, an increase of $212,000 or 87%. This increase was a result of Trimedyne increasing its efforts to improve and develop new delivery systems through an increase in staff along with the preparation of related regulatory submissions. Other income, net decreased by $188,000 to $125,000 in the current nine-month period from $313,000 in the nine- month period of fiscal 2004. During the current year nine-month period $133,000 was received in royalties, $11,000 in interest income. Other income during the current nine-month period ended June 30, 2005 was offset by accrued interest on notes due to the CEO. In November 2003, the Company settled litigation with Lumenis, Inc. which resulted in the reduction of $88,000 in the liability for royalties in the quarter ended December 31, 2003 and the receipt of $155,000 in technology fees and royalties of $26,000 during the quarter ended June 30, 2004. During the previous year's quarter ended December 31, 2003 the Company also received $53,000 for an unrelated cash insurance settlement for a damaged laser. Other income for the previous nine-month period ended June 30, 2004 was offset by accrued on notes due to the CEO. For the nine months ended June 30, 2005, Trimedyne had a net loss of $4,000 or $(0.00) per share, based on 14,602,931 basic weighted average number of common shares outstanding, as compared to a net income of $472,000, or $0.03 per share, based on 14,548,428 basic weighted average number of common shares outstanding in the same period of the previous year, resulting from the above mentioned factors. Liquidity and Capital Resources ------------------------------- At June 30, 2005, the Company had working capital of $3,535,000 compared to $3,529,000 at the end of the fiscal year ended September 30, 2004. Cash and cash equivalents decreased by $166,000 to $1,517,000 from $1,683,000 at the fiscal year ended September 30, 2004. During the nine month period ended June 30, 2005, net cash of $94,000 was used by operating activities along with $75,000 used in investing activities purchasing and upgrading computer equipment company-wide and purchasing rental equipment for MST, Inc. Notes payable increased by $110,000, primarily for the financing of insurance policies, while $107,000 was used for payments on debt, which resulted in net cash provided by financing activities of $3,000. 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. While we expect 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 operate profitably, or if we undertake the development, testing and marketing of additional 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 into shares of the Company's common stock 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. 16 Item 3. CONTROLS AND PROCEDURES As of June 30, 2005, an evaluation was carried out under the supervision and with the participation of the Company's management, including our Chief Executive Officer, of the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rule 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934). Based upon that evaluation, the Chief Executive Officer concluded that the design and operation of these disclosure controls and procedures were effective. No significant changes were made in our internal controls or in other factors that could significantly affect these controls subsequent to June 30, 2005. (a) Evaluation of Disclosure Controls and Procedures. The Company carried out an evaluation under the supervision and with the participation of the Company's management, including the Company's Chief Executive Officer ("CEO") of the effectiveness of the Company's disclosure controls and procedures. Based upon that evaluation, the CEO concluded that as of June 30, 2005 our disclosure controls and procedures were effective in timely alerting them to the material information relating to the Company (or the Company's consolidated subsidiaries) required to be included in the Company's periodic filings with the SEC, subject to the various limitations on effectiveness set forth below under the heading, "LIMITATIONS ON THE EFFECTIVENESS OF INTERNAL CONTROLS," such that the information relating to the Company, required to be disclosed in SEC reports (i) is recorded, processed, summarized and reported within the time periods specified in SEC rules and forms, and (ii) is accumulated and communicated to the Company's management, including our CEO, as appropriate to allow timely decisions regarding required disclosure. (b) Changes in internal control over financial reporting. There has been no change in the Company's internal control over financial reporting that occurred during the fiscal quarter ended June 30, 2005 that has materially affected, or is reasonably likely to materially affect, the Company's internal control over financial reporting. LIMITATIONS ON THE EFFECTIVENESS OF INTERNAL CONTROLS The Company's management, including the CEO, does not expect that our disclosure controls and procedures or our internal control over financial reporting will necessarily prevent all fraud and material error. An internal control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the control system are met. Further, the design of the control system must reflect the fact that there are resource constraints and the benefits of controls must be considered relative to their costs. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud, if any, within the Company have been detected. These inherent limitations include the realities that judgments in decision-making can be faulty and that breakdowns can occur because of simple error or mistake. Additionally, controls can be circumvented by the individual acts of some persons, by collusion of two or more people, or by management override of the internal control. The design of any system of controls also is based in part upon certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions. Over time, control may become inadequate because of changes in conditions, and/or the degree of compliance with the policies or procedures may deteriorate. 17 PART II Other Information ITEM 1. Legal Proceedings On November 17, 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, which the Company had accrued, 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. The above technology fee and royalties were received during the fiscal year ended September 30, 2004 and royalties are currently being received per the above agreement and included in other income for the current three and nine months periods ended June 30, 2005. The Company is currently a defendant in one product liability lawsuit. This case relates to injuries that occurred in connection with medical procedures in which the Company's laser was used. 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. Trimedyne would be liable for any judgement in excess of $5,000,000. At June 30, 2005, the Company accrued $50,000 as a loss contigency on this claim, based on the deductible under the insurance policy, of which $14,000 was paid in attorney fees as of June 30, 2005. 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 (a) Exhibits 99.1 Officer Certification 99.2 Controller Certification 18 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: August 19, 2005 /s/ Marvin P. Loeb -------------------------- ------------------------------------ Marvin P. Loeb Chairman and Chief Executive Officer Date: August 19, 2005 /s/ Jeffrey S. Rudner -------------------------- ------------------------------------ Jeffrey S. Rudner Controller 19 TRIMEDYNE, INC. CERTIFICATION OF PRINCIPAL EXECUTIVE OFFICER I, Marvin P. Loeb, certify that: 1. I have reviewed this quarterly report on Form 10-QSB of Trimedyne, Inc.; 2. Based on my knowledge, this 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 report. 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the small business issuer as of, and for, the periods presented in this report; 4. The small business issuer's other certifying officer and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)(4) and 15d-15(e)(4)) for the registrant and have: (a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the small business issuer, including its consolidated subsidiaries, is made know to us by others within those entities, particularly during the period in which this report is being prepared; (b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; (c) evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and (d) disclose in future reports any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the small business issuer's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect the registrant's internal control over financial reporting; 5. The small business issuer's other certifying officer and I will disclose in future filings, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions): (a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the small business issuer's ability to record, process, summarize and report financial information; and (b) any fraud, whether or not material, that involves management or other employees who have a significant role in the small business issuer' internal control over financial reporting. DATED: August 19, 2005 /s/ Marvin P. Loeb ------------------------------------ Marvin P. Loeb Chairman and Chief Executive Officer 20 CERTIFICATION OF CONTROLLER I, Jeffrey s. Rudner, certify that: 1. I have reviewed this quarterly report on Form 10-QSB of Trimedyne, Inc.; 2. Based on my knowledge, this 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 report. 3. Based on my knowledge, the financial statements, and other financial information included in this report, fairly present in all material respects the financial condition, results of operations and cash flows of the small business issuer as of, and for, the periods presented in this report; 4. The small business issuer's other certifying officer and I am responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-15(e)(4) and 15d-15(e)(4)) for the registrant and have: (a) designed such disclosure controls and procedures, or caused such disclosure controls and procedures to be designed under our supervision, to ensure that material information relating to the small business issuer, including its consolidated subsidiaries, is made know to us by others within those entities, particularly during the period in which this report is being prepared; (b) designed such internal control over financial reporting, or caused such internal control over financial reporting to be designed under our supervision, to provide reasonable assurance regarding the reliability of financial reporting and the preparation of financial statements for external purposes in accordance with generally accepted accounting principles; (c) evaluated the effectiveness of the registrant's disclosure controls and procedures and presented in this report our conclusions about the effectiveness of the disclosure controls and procedures, as of the end of the period covered by this report based on such evaluation; and (d) disclose in future reports any change in the registrant's internal control over financial reporting that occurred during the registrant's most recent fiscal quarter (the small business issuer's fourth fiscal quarter in the case of an annual report) that has materially affected, or is reasonably likely to materially affect the registrant's internal control over financial reporting; 5. The small business issuer's other certifying officer and I will disclose in future filings, based on our most recent evaluation of internal control over financial reporting, to the registrant's auditors and the audit committee of the registrant's board of directors (or persons performing the equivalent functions): (a) all significant deficiencies and material weaknesses in the design or operation of internal control over financial reporting which are reasonably likely to adversely affect the small business issuer's ability to record, process, summarize and report financial information; and (b) any fraud, whether or not material, that involves management or other employees who have a significant role in the small business issuer' internal control over financial reporting. DATED: August 19, 2005 /s/ Jeffrey S. Rudner -------------------------------- Jeffrey S. Rudner Controller 21