UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-QSB [X] QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. FOR THE QUARTERLY PERIOD ENDED JUNE 30, 2005 OR [ ] TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934. FOR THE TRANSITION PERIOD FROM TO COMMISSION FILE NUMBER: 001-31925 VASO ACTIVE PHARMACEUTICALS, INC. (Exact name of small business issuer as specified in its charter) DELAWARE 02-0670926 (State or other jurisdiction (IRS Employer Identification No.) of incorporation or organization) 99 ROSEWOOD DRIVE, SUITE 260 DANVERS, MA 01923 (Address of principal executive offices) (Zip code) ISSUER'S TELEPHONE NUMBER: (978) 750-1991 Check whether the issuer (1) filed all reports required to be filed by Section 13 or 15(d) of the Exchange Act during the past 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirements for the past 90 days. Yes [X] No [ ] State the number of shares outstanding of each of the issuer's classes of common equity, as of the latest practicable date: Common stock, Class A, $0.0001 par value 5,828,613 shares outstanding on August 22, 2005 Common stock, Class B, $0.0001 par value 4,500,000 shares outstanding on August 22, 2005 VASO ACTIVE PHARMACEUTICALS, INC. INDEX TO FORM 10-QSB page PART I. FINANCIAL INFORMATION ITEM 1 - Condensed Financial Statements (unaudited): Condensed Balance Sheets as of June 30, 2005 and December 31, 2004 ......... 3 Condensed Statements of Operations for the Three-month Periods Ended June 30, 2005 and 2004............................................. 4 Condensed Statements of Operations for the Six-month Periods Ended June 30, 2005 and 2004............................................. 5 Condensed Statements of Cash Flows for the Six-Month Periods Ended June 30, 2005 and 2004............................................. 6 Notes to the Condensed Financial Statements................................. 7 ITEM 2 - Management's Discussion and Analysis of Financial Condition and Results of Operations.............................................. 12 ITEM 3 - Controls and Procedures............................................ 36 PART II. OTHER INFORMATION ITEM 1 - Legal Proceedings.................................................. 37 ITEM 6 - Exhibits and Reports on Form 8-K................................... 40 Signature................................................................... 41 Unless the context requires otherwise, references in this Quarterly Report to "Vaso Active," "the Company," "we," "our" and "us" refer to Vaso Active Pharmaceuticals, Inc. Vaso Active, A-R Extreme(R), Termin8(R), RepiDerm(R), and our logo are trademarks of the Company. Osteon(R) and PENtoCORE(R) are registered trademarks of BioChemics, Inc. This Quarterly Report on Form 10-QSB also contains trademarks and trade names of other parties. 2 VASO ACTIVE PHARMACEUTICALS, INC. CONDENSED BALANCE SHEETS JUNE 30, DECEMBER 31 ----------- ----------- 2005 2004 ----------- ----------- (UNAUDITED) ASSETS CURRENT ASSETS: Cash and cash equivalents ................................... $ 490,856 $ 2,175,388 Accounts receivable ......................................... 1,268 888 Inventory ................................................... 127,967 140,296 Prepaid expenses ............................................ 43,482 28,995 ----------- ----------- TOTAL CURRENT ASSETS ................................... 663,573 2,345,567 Property and equipment - net ................................ 61,306 37,551 ----------- ----------- $ 724,879 $ 2,383,118 =========== =========== LIABILITIES AND STOCKHOLDERS' EQUITY CURRENT LIABILITIES: Accounts payable ............................................ $ 358,084 $ 474,369 Accrued compensation ........................................ 37,470 43,805 Other accrued expenses ...................................... 69,016 116,045 Obligations under capital leases - short-term portion ....... 2,503 -- Due to parent company ....................................... 20,519 10,780 ----------- ----------- TOTAL CURRENT LIABILITIES ................................ 487,592 644,999 LONG-TERM LIABILITIES: Obligations under capital leases - long-term portion ........ 12,644 -- Accrued legal settlement..................................... 750,000 ----------- ----------- TOTAL LONG-TERM LIABILITIES ............................. 762,644 -- ----------- ----------- 1,250,236 644,999 ----------- ----------- STOCKHOLDERS' EQUITY: Preferred stock - $0.0001 par value; authorized 10,000,000 shares; issued and outstanding, none ......... -- -- Common stock - $0.0001 par value; authorized 30,000,000 shares; issued and outstanding, 10,328,613 ... 1,033 1,033 Additional paid-in capital .................................. 8,093,656 8,093,656 Deferred compensation ....................................... (153,575) (183,777) Accumulated deficit ......................................... (8,466,471) (6,172,793) ----------- ----------- TOTAL STOCKHOLDERS' EQUITY ............................... (525,357) 1,738,119 ----------- ----------- $ 724,879 $ 2,383,118 =========== =========== See notes to the unaudited condensed financial statements. 3 VASO ACTIVE PHARMACEUTICALS, INC. UNAUDITED CONDENSED STATEMENTS OF OPERATIONS THREE-MONTH PERIOD ENDED JUNE 30, SIX-MONTH PERIOD ENDED JUNE 30, ---------------------------- ---------------------------- 2005 2004 2005 2004 ------------ ------------ ------------ ------------ Net revenues ....................................... $ 11,199 $ 862 $ 15,796 $ 8,009 Cost of revenues .................................. 13,467 39,853 19,715 45,628 ------------ ------------ ------------ ------------ GROSS PROFIT ................................. (2,268) (38,991) (3,919) (37,619) ------------ ------------ ------------ ------------ Costs and expenses: Marketing, advertising and promotion .......... 31,933 10,595 201,736 76,849 Selling, general and administrative ........... 458,805 1,050,874 1,142,346 2,588,867 Research and development ...................... 87,407 47,299 177,437 142,466 Legal settlement .............................. 750,000 -- 750,000 -- Stock based compensation ...................... 15,101 15,101 30,202 124,134 ------------ ------------ ------------ ------------ Loss from operations ........................ (1,345,514) (1,162,860) (2,305,640) (2,969,935) Other income (expense), net ........................ 4,624 18,895 11,960 22,381 ------------ ------------ ------------ ------------ NET LOSS ........................................... $ (1,340,890) $ (1,143,965) $ (2,293,678) $ (2,947,554) ============ ============ ============ ============ Net loss per share - basic and diluted (Note 2) .... $ (0.13) $ (0.11) $ (0.22) $ (0.29) ============ ============ ============ ============ Weighted average shares outstanding - basic and diluted (Note 2) ................................... 10,328,613 10,328,613 10,286,077 10,264,570 ============ ============ ============ ============ See notes to the unaudited condensed financial statements. 4 VASO ACTIVE PHARMACEUTICALS, INC. UNAUDITED CONDENSED STATEMENTS OF CASH FLOWS SIX-MONTH PERIOD ENDED JUNE 30, -------------------------- 2005 2004 ----------- ----------- CASH FLOWS FROM OPERATING ACTIVITIES: Net loss .................................................................. $(2,293,678) $(2,947,554) Adjustments to reconcile net loss to net cash used in operating activities: Depreciation and amortization ........................................ 5,643 522 Stock-based compensation (Note 4) .................................... 30,202 124,134 Inventory write-off ................................................. 10,632 38,871 Accrued legal settlement.............................................. 750,000 200,000 Increase (decrease) in cash from change in: Accounts receivable ............................................... (380) 1,048 Inventory ......................................................... 1,697 (49,197) Prepaid expenses .................................................. (14,487) 24,265 Accounts payable .................................................. (116,285) 174,025 Accrued compensation .............................................. (6,335) (236,813) Other accrued expenses ............................................ (47,029) 66,098 ----------- ----------- Net cash used in operating activities ....................... (1,680,020) (151,117) ----------- ----------- CASH FLOWS FROM INVESTING ACTIVITIES: Purchase of property and equipment ......................................... (14,064) (5,222) ----------- ----------- Net cash used in investing activities ....................... (14,064) (5,222) ----------- ----------- CASH FLOWS FROM FINANCING ACTIVITIES: Issuance of Class A common stock ......................................... -- 450,000 Issuance of convertible notes ............................................ -- 7,500,000 Repayment of convertible notes ........................................... -- (7,500,000) Obligations under capital leases ......................................... (187) -- Due to/from parent company ............................................... 9,739 (56,993) ----------- ----------- Net cash provided by financing activities ................... 9,552 393,007 ----------- ----------- NET INCREASE (DECREASE) IN CASH AND CASH EQUIVALENTS ....................... (1,684,532) (2,216,816) CASH AND CASH EQUIVALENTS, BEGINNING OF PERIOD ............................. 2,175,388 6,109,775 ----------- ----------- CASH AND CASH EQUIVALENTS, END OF PERIOD ................................... $ 490,856 $ 3,892,959 =========== =========== SUPPLEMENTAL DISCLOSURES: Interest paid ........................................................... $ -- $ -- Income taxes paid ....................................................... -- -- NONCASH DISCLOSURES: Issuance of capital leases and acquired equipment ....................... $ 15,335 $ -- See notes to the unaudited condensed financial statements. 5 VASO ACTIVE PHARMACEUTICALS, INC. NOTES TO UNAUDITED CONDENSED FINANCIAL STATEMENTS 1. NATURE OF BUSINESS AND BASIS OF PRESENTATION THE COMPANY Vaso Active Pharmaceuticals, Inc. (the "Company") is an early-stage company focused on commercializing; marketing and selling over-the-counter ("OTC") pharmaceutical products that incorporate a patented vaso active lipid encapsulated ("VALE") technology and a proprietary PENtoCORE technology. The Company is engaged in a single operating segment of the OTC pharmaceutical industry. The Company licenses the VALE patents and PENtoCORE technology from BioChemics, Inc. ("BioChemics"), a privately owned biopharmaceutical company. The Company issued 4,500,000 shares of its Class B common stock to BioChemics in consideration for the exclusive worldwide rights to commercialize market and sell the VALE technology for OTC pharmaceutical products. These shares were issued pursuant to authorization from the Company's Board of Directors on June 20, 2003. SETTLEMENT OF SECURITIES AND EXCHANGE COMMISSION MATTERS On August 26, 2004, the U.S. Securities and Exchange Commission (the "SEC") formally approved the terms of a settlement regarding alleged violations of securities laws stemming from allegedly misleading disclosures in the Company's initial public offering registration statement, its 2003 annual report and a statement on its website concerning the Food and Drug Administration's (the "FDA") approval or qualification of the Company's products. The Company has agreed with the SEC to settlement terms without the Company admitting or denying the allegations of the civil complaint, pursuant to which the Company is permanently enjoined from violating the anti-fraud provisions of the Securities Act of 1933, as amended, and the antifraud and reporting provisions of the Securities Exchange Act of 1934, as amended. The SEC action filed with the United States District Court for the District of Columbia (the "Court") is styled SECURITIES AND EXCHANGE COMMISSION V. VASO ACTIVE PHARMACEUTICALS, INC. Civil Action No. 04 CV 01395 (RJL) (D.D.C.). In addition, the SEC formally approved the terms of a settlement with John J. Masiz, formerly the Company's President and Chief Executive Officer, without him admitting or denying the allegations of the civil complaint, that likewise enjoins him from violating the antifraud and reporting provisions, and prevents him from serving as an officer or director of any public company, including the Company, for a period of five years. Effective as of August 17, 2004, Mr. Masiz resigned as an executive officer and a director of the Company. He is, however, permitted to remain an active employee and/or consultant of the Company. In light of the foregoing, the Company and Mr. Masiz agreed to terminate his employment agreement and enter into a new agreement. Pursuant to that agreement, Mr. Masiz will provide strategic consulting services regarding sales, marketing and business development to the Company for an initial term through June 30, 2008 and will report to the Chief Executive Officer of the Company. The Company has appointed its Chief Financial Officer to serve as its President and Acting Chief Executive Officer while the Company conducts a search for a new Chief Executive Officer. On September 13, 2004, the Court for the District of Columbia entered final judgments against the Company and Mr. Masiz, pursuant to the above referenced settlement terms. PRIVATE LITIGATION In April, May, and June 2004, the Company and certain of its officers (the "Defendants") were sued in several securities class action lawsuits filed in the United States District Court for the District of Massachusetts. The complaints, sought equitable and monetary relief, an unspecified amount of damages, with interest, attorneys' fees and costs, allegedly were filed on 6 behalf of purchasers of the Company's Class A common stock during the period December 11, 2003 to March 31, 2004. The complaints alleged that during the period in question the Defendants violated the federal securities laws by allegedly failing to make accurate and complete disclosures concerning the Company, its financial condition, its business operations and future prospects, the clinical trial and endorsement of the Company's Termin8 anti-fungal product and the institutional demand for the Company's securities. The majority of these complaints were consolidated in the United States District Court for the District of Massachusetts, under the caption IN RE VASO ACTIVE PHARMACEUTICALS SECURITIES LITIGATION, Civ. No. 04-10708 (RCL), (the "Consolidated Action"). On June 1, 2005, the Company entered into a Memorandum of Understanding Concerning Settlement Terms ("MOU") to settle the consolidated securities class action lawsuit. Under the terms of the MOU, the lead plaintiffs and the settling defendants agree that the final stipulation will contain a disclaimer of liability consistent with the MOU. Subject to the terms and conditions set forth in the MOU, settling defendants will pay into escrow for the benefit of the class $1,100,000 in cash and $750,000 face amount of 2-year 5% subordinated callable notes convertible at $1.75 per share within 10 business days of preliminary approval of the settlement by the court. In consideration of this payment, the parties will fully and finally release and discharge all claims against each other. The settlement still needs court approval. The Company's insurance carrier has agreed to pay the $1,100,000 cash payment in exchange for a release of its liability under its insurance policy with the Company. The Company recorded a charge of $750,000 during the three-month period ended June 30, 2005 in connection with this settlement, the corresponding liability has been recorded as accrued legal settlement on the balance sheet. The Company intends to record the 2-year 5% subordinated callable notes when it receives a final settlement by the court. The Company has also been named as a nominal defendant in three shareholder derivative actions. The first action was filed in the United States District Court for the District of Massachusetts in April 2004 against the Company's directors and certain of its officers and against BioChemics, Inc. styled JOSEPH ROSENKRANTZ V. BIOCHEMICS, INC., ET AL., Civ. No. 04-10792 (RCL) (D. Mass.); the second - filed in June 2004, also against the Company's directors and certain of its officers and against BioChemics, Inc. styled WILLIAM POMEROY V. BIOCHEMICS INC., ET AL., Civ. No. 04-11399 (RCL) (D. Mass.); and the third - in the Court of Chancery for the State of Delaware in September 2004 against its directors and certain of its officers entitled DOUGLAS WEYMOUTH V. VASOACTIVE ET AL., Civ. No. 682-N (collectively, the "Complaints"). The Complaints allege, among other things, that the alleged conduct challenged in the securities cases pending against the Company in Massachusetts (described above) constitutes a breach of the Defendants' fiduciary duties to the Company. The Complaints seek equitable and monetary relief, an unspecified amount of damages, and attorneys and other fees, costs and expenses, ostensibly on behalf of the Company. On October 29, 2004, the Massachusetts Court approved a joint motion to consolidate the two Massachusetts derivative actions. The Delaware court has approved the parties' stipulated stay of all proceedings in the Delaware derivative action, at least until the resolution of the motion to dismiss the consolidated securities fraud litigation. Although the Company intends to vigorously defend against the Complaints, there can be no guarantee as to the ultimate outcome of these matters. There is also no guarantee that these will be the only lawsuits brought against the Company with respect to these matters. In addition, if a substantial amount is payable by the Company with respect to the Complaints and is not reimbursed through its director and officer insurance policy, this will have a material adverse effect on the Company's financial position and liquidity. For the six-month periods ended June 30, 2005 and 2004, the Company recorded approximately $816,300 and $719,000, respectively, in expenses to defend itself in the SEC and private litigation matters discussed above, including legal, accounting and other consulting fees. The June 30, 2005 amounts include the $750,000 charge in connection with the Company's settlement with the consolidated securities class action lawsuit. 7 FOOD AND DRUG ADMINISTRATION MATTERS The Company is not aware whether the FDA is contemplating any action against it. The Company believes that the active ingredients, dosage form and strengths of its A-R Extreme, Osteon (R) and Termin8(TM) products are covered by the FDA's OTC Review Program and therefore believe these products are currently eligible for marketing under the same program. The Company intended to distribute these products under revised labeling once it was reasonably sure that the marketing of these products is consistent with the FDA's requirements and policies. In May 2004, the Company submitted new labels for its previously marketed products to the FDA and has requested FDA comments on these labels. There is no regulatory requirement that the FDA review or comment on such materials and so far, the FDA has not provided any comment relating to the new labels. Although the Company has not been provided any comment from the FDA, the Company is now reasonably sure that these new labels are consistent with all FDA regulations and policies and as a result, the Company resumed marketing and shipment of its products in September 2004. EXCHANGE LISTING MATTERS In April 2004, the Listing Investigations staff of The Nasdaq Stock Market, Inc. ("Nasdaq") notified the Company that it had commenced an inquiry into the Company's compliance with Nasdaq's continued listing requirements and requested certain information from the Company relating to the pending regulatory matters. In light of the substantial administrative and cash burdens being borne by the Company at the time as well as the substantial legal costs anticipated with respect to the pending SEC and FDA matters, the Company determined that it was in the best interest of its shareholders to voluntarily cease listing of its securities. Therefore, upon the Company's request and effective on April 8, 2004, the Company's securities ceased to be listed on Nasdaq. Presently, the Company's securities are being quoted in the Over The Counter Pink Sheets. The Company intends to seek listing of its securities on an exchange or other automated quotation system. However, there is no assurance that the Company will be successful in securing such listing or quotation or, even if it is successful, that it will be able to maintain the listing or quotation of its securities on such exchange or quotation system. UNWINDING OF PRIVATE INVESTMENT IN PUBLIC ENTITY On March 16, 2004, the Company entered into a private placement transaction in the amount of $7,500,000 with an institutional investor. The investment was in the form of an 18 month 2% Convertible Note (the "Note") convertible into shares of the Company's Class A common stock at a conversion rate of $9.00 per share, at the option of the investor. In addition, the Company issued to the investor warrants to purchase 166,667 shares of Class A common stock at an exercise price of $8.75 per share. Given that the initiation and continuation of the April 1, 2004 trading suspension by the SEC constituted a breach under the Note, the Company and the investor agreed, pursuant to the terms of a settlement agreement entered into on April 8, 2004, that the Company would immediately repay the investor the sum of $7,500,000 in cash without penalty, interest, redemption premium or any other premium or penalty, plus an expense reimbursement in connection with the settlement agreement in the amount of $15,000 in cash. In consideration of this repayment, the investor surrendered the Note and warrants and the parties mutually terminated all other agreements entered into in connection with the transaction. In connection with this transaction, the Company paid approximately $600,000 in financing fees, legal, accounting and other various fees to third parties. These fees were not refunded when the Company repaid the investor. These fees were recorded as an expense during three-month period ended March 31, 2004. 2. NET LOSS PER SHARE Basic net loss per share is computed by dividing net loss by the weighted average number of common shares outstanding for the period. Diluted net loss per share reflects, in addition to the weighted average number of common shares, the potential dilution if stock options and warrants outstanding were exercised and/or converted into common stock, unless the effect of such equivalent shares was antidilutive. 8 For the three-month and six-month periods ended June 30, 2005 and 2004, the effect of stock options and other potentially dilutive shares were excluded from the calculation of diluted net loss per common share as their inclusion would have been antidilutive. 3. REVENUE RECOGNITION The Company recognizes revenue from product sales in accordance with generally accepted accounting principles in the United States, including the guidance in Staff Accounting Bulletin ("SAB") No. 104, "Revenue Recognition," which supercedes SAB No. 101, "Revenue Recognition in Financial Statements," and Statement of Financial Accounting Standards ("SFAS") No. 48, "Revenue Recognition When Right of Return Exists." Revenue from product sales is recognized when there is persuasive evidence of an arrangement, delivery has occurred, the price is fixed and determinable, and collectibility is reasonably assured. However, because the Company's products are sold with limited rights of return, revenue is recognized when the price to the buyer is fixed, the buyer is obligated to pay the Company and the obligation to pay is not contingent on resale of the product, the buyer has economic substance apart from the Company, the Company has no obligation to bring about the sale of the product and the amount of returns can be reasonably estimated. The Company records allowances for product returns, rebates and discounts, and reports revenue net of such allowances. The Company must make judgments and estimates in preparing the allowances that could require adjustments in the future. For instance, customers have the right to return any product that is held past the labeled expiration date. The Company bases its estimates on historic patterns of returns and on the expiration dates of product currently being shipped, or as a result of an actual event that may give rise to a significant return amount such as the discontinuance of a product. The Company does not recognize revenue unless collectibility is reasonably assured. The Company maintains allowances for doubtful accounts for estimated losses resulting from the inability of its customers to make required payments. If the financial condition of our customers were to deteriorate and result in an impairment of their ability to make payments, additional allowances may be required. 4. STOCK-BASED COMPENSATION The Company accounts for stock-based employee compensation arrangements using the intrinsic value method in accordance with Accounting Principles Board Opinion ("APB") No. 25, "Accounting for Stock Issued to Employees," and complies with the disclosure provisions of SFAS No. 123, "Accounting for Stock-Based Compensation." Under the intrinsic value method, compensation associated with stock awards to employees and non-employee directors is determined as the excess, if any, of the current fair value of the underlying common stock on the date compensation is measured over the price an employee or director must pay to exercise the award. The Company accounts for stock options and awards to non-employees using the fair value method. The Company has an employee stock incentive plan and a non-employee director compensation plan, which are described more fully in Note 7 to the Company's Annual Report on Form 10-KSB for the period ended December 31, 2004. The following table illustrates the effect on net loss and net loss per share if the Company had applied the fair-value recognition provisions of SFAS No. 123, as amended, to options granted under the stock option plans and rights to acquire stock granted under the Company's stock option plans. For purposes of this PRO-FORMA disclosure, the value of the options is estimated using a Black-Scholes option pricing model and amortized ratably to expense over the options' vesting periods. Because the estimated value is determined as of the date of grant, the actual value ultimately realized by the employee may be significantly different. 9 THREE-MONTH THREE-MONTH PERIOD PERIOD ENDED ENDED JUNE 30, 2005 JUNE 30, 2004 ------------ ------------ Net loss, as reported ..................................................... $ (1,340,890) $ (1,143,965) Add: stock-based compensation included in the determination of net loss ... 15,101 15,101 Less: stock-based compensation had all options been recorded at fair value .................................................................. (103,544) (121,129) ------------ ------------ Adjusted net loss ......................................................... $ (1,429,333) $ (1,249,993) ============ ============ Weighted average shares outstanding, basic and diluted .................... 10,328,613 10,328,613 Net loss per share, basic and diluted, as reported ........................ $ (0.13) $ (0.11) Adjusted net loss per share, basic and diluted ............................ $ (0.14) $ (0.12) SIX-MONTH SIX-MONTH PERIOD PERIOD ENDED ENDED JUNE 30, 2005 JUNE 30, 2004 ------------ ------------ Net loss, as reported ..................................................... $ (2,293,678) $ (2,947,554) Add: stock-based compensation included in the determination of net loss ... 30,202 124,134 Less: stock-based compensation had all options been recorded at fair value .................................................................. (215,502) (623,043) ------------ ------------ Adjusted net loss ......................................................... $ (2,478,978) $ (3,455,463) ============ ============ Weighted average shares outstanding, basic and diluted .................... 10,328,613 10,264,570 Net loss per share, basic and diluted, as reported ........................ $ (0.22) $ (0.29) Adjusted net loss per share, basic and diluted ............................ $ (0.24) $ (0.34) In December 2004, the Financial Accounting Standards Board, or FASB, issued a revision to SFAS No. 123R, "Share-Based Payment," requiring companies to recognize as compensation expense the fair value of stock options and other equity-based compensation issued to employees. This revised statement eliminates the intrinsic value method provided under APB No. 25, which is the method the Company currently uses to value stock options awarded to its employees. This revised standard is effective as of the beginning of the first annual reporting period beginning after December 15, 2005 and is expected to have a material impact on the Company's results of operations. The Company is evaluating the two methods of adoption allowed by SFAS 123R; the modified-prospective transition method and the modified-retrospective transition method. 5. SUBSEQUENT EVENT On August 16, 2005, the Company sold $2,500,000 in aggregate principal amount of Senior Secured Convertible Notes due May 1, 2007, (the "Notes") to independent institutional investors. The Notes are convertible at any time into shares of the Company's Class A common stock at a price of $0.70 per share (subject to adjustment under certain circumstances). The investors also received five-year warrants ("Warrants") to purchase a total of 1,298,701 shares of the Company's Class A common stock at an exercise price of $0.77 per share. In addition, the 10 investors received rights ("Rights") to purchase up to $1,875,000 in aggregate principal amount of additional Notes at any time through the maturity date of the Notes, together with additional Warrants to purchase a total of 974,026 shares of Class A common stock. The additional Notes are convertible and the additional Warrants are exercisable at the same respective prices per share as the Notes and Warrants which the Company issued today. The Notes bear interest at the six month LIBOR plus 6.0%, with a floor of 10.0% and a ceiling of 12.0%. Interest is payable quarterly in either cash or registered Class A Common Stock at the Company's option. As part of the agreement, the Company has placed $437,000 into escrow for the purpose of funding substantially all of the interest payments due under the Notes. The fair value of the detachable warrants will be calculated using the Black-Scholes valuation model and will be recorded as a discount on the Senior Notes and accreted over the expected life of the warrants as interest expense. 11 ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS FORWARD-LOOKING INFORMATION This Quarterly Report on Form 10-QSB contains "forward-looking statements" within the meaning of Section 27A of the Securities Act of 1933, as amended, and section 21E of the Exchange Act of 1934, as amended, that are based on management's exercise of business judgment as well as assumptions made by, and information currently available to management. When used in this document, the words "may," "will," "anticipate," "believe," "estimate," "intend," and words of similar import, are intended to identify any forward-looking statements. You should not place undue reliance on these forward-looking statements. These statements reflect our current view of future events and are subject to certain risks and uncertainties as noted below. Should one or more of these risks and uncertainties materialize, or should underlying assumptions prove incorrect, our actual results could differ materially from those anticipated in these forward-looking statements. We undertake no obligation and do not intend to update, revise or otherwise publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of any unanticipated events after the date hereof or to reflect the occurrence of any unanticipated events. Although we believe that our expectations are based on reasonable assumptions, we can give no assurance that our expectations will materialize. Management's Discussion and Analysis of Financial Condition and Results of Operations should be read together with our condensed financial statements and related notes included elsewhere in this Quarterly Report on Form 10-QSB. This Quarterly Report on Form 10-QSB, including the following discussion, contains trend analysis and other forward-looking statements within the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Any statements in this Quarterly Report on Form 10-QSB that are not statements of historical facts are forward-looking statements. These forward looking statements made herein are based on our current expectations, involve a number of risks and uncertainties and should not be considered as guarantees of future performance. At June 30, 2005, the most predominant adverse factor affecting the Company continued to be its level of working capital. At June 30, 2005 the Company had working capital of approximately $176,000. On August 16, 2005, the Company obtained and closed on additional financing through the issuance of Senior Secured Convertible Notes (the "Notes") in the aggregate principal amount of $2,500,000. In addition, the investors received rights (Rights) to purchase up to $1,875,000 in aggregate principal amount of additional Notes at any time through the maturity of the Notes.. At August 19, 2005, the Company had working capital of approximately $1,600,000. The Notes contain an additional investment right (the "AIR) feature. See further discussion of this issue in the "LIQUIDITY AND CAPITAL RESOURCES" sections of the Management's Discussion and Analysis. Based on our current plans and assumptions relating to our operations, we believe that the additional working capital from the AIR, if exercised in full, to satisfy our cash requirements through December 31, 2006. There can be no assurance that the AIR will be exercised. If none of the AIR is exercised, we expect, based on our current plans and assumptions relating to our operations, that our working capital at August 19, 2005 will satisfy our cash requirements through May 31, 2006. Factors that could cause actual results to differ materially include without limitation: o interruptions or cancellation of existing contracts o impact of competitive products and pricing o product demand and market acceptance and risks o the presence of competitors with greater financial resources o product development and commercialization risks o an inability to arrange additional debt or equity financing o our ability to finance our business 12 o our ability to maintain our current pricing model and/or decrease our cost of sales o continued availability of supplies or materials used in manufacturing at the current prices o adverse regulatory developments in the United States o entrance of competitive products in our markets o the ability of management to execute plans and motivate personnel in the execution of those plans o no adverse publicity related to our products or the company itself o no adverse claims relating to our intellectual property o the adoption of new, or changes in, accounting principles; legal proceedings o the costs inherent with complying with new statutes and regulations applicable to public reporting companies, such as the Sarbanes-Oxley Act of 2002 o other new lines of business that the Company may enter in the future. o our ability to repay our indebtedness, including repayment of our senior secured notes issued recently. Actual results may differ materially from those set forth in such forward-looking statements as a result of factors set forth elsewhere in this Quarterly Report on Form 10-QSB, including under "Risk Factors." More information about factors that potentially could affect the Company's financial results is included in the Company's filings with the Securities and Exchange Commission. OVERVIEW, KEY BUSINESS CHALLENGES AND RISKS Vaso Active Pharmaceuticals, Inc. is an early stage company, headquartered in Danvers, Massachusetts, which focuses on commercializing, marketing and selling over-the-counter pharmaceutical products that incorporate a patented vaso active lipid encapsulated ("VALE") technology and a proprietary PENtoCORE technology. The unique VALE technology is a patchless, lipid-based delivery system which the Company is formulating into various applications which the Company hopes to market in the future, subject to receipt of appropriate FDA approvals. The technology uses an active process, incorporating chemical vasodilators, to deliver drugs through the skin and into the bloodstream. The PENtoCORE technology is a topical formulation, in contrast to the VALE transdermal technology. The Company is currently marketing three products that incorporate the proprietary PENtoCORE technology; the Company has one additional product candidate currently undergoing package design and branding and multiple additional product candidates at various stages of formulation and development. We began our operations in January 2001, as a division of BioChemics, a biopharmaceutical company engaged in the development of transdermal and topical drug delivery systems. BioChemics is based in Danvers, Massachusetts. BioChemics was founded in 1989 by John J. Masiz and was incorporated in Delaware in 1991. BioChemics began developing the VALE technology in 1989 and has subsequently been issued 4 U.S. patents in connection with this technology. As an early stage company, we are subject to a number of risks typical of early stage companies including, but not limited to, our need to obtain additional financing and generate profitability and cash flows from operations. As a company engaged in the pharmaceutical industry, we are subject to a number of risks typical of biopharmaceutical companies including, but not limited to, our need to adhere to strict governmental regulations, our ability to withstand intense competition from larger companies with greater financial resources and our ability to defend our intellectual property, as licensed from BioChemics. Our general business strategy was adversely affected by regulatory and private securities actions taken against us and our management beginning in April 2004. At the same time, we suspended the marketing and sale of our products until we were reasonably sure that our product marketing was consistent with the FDA's requirements and policies. As a result of our voluntary delisting and continuation of delisting of our securities from the Nasdaq, the action taken by the SEC against us, the issues raised by the FDA regarding the regulatory status of our products, and the significant decline in the market value of our securities subsequent to these matters, several shareholder actions were filed against Vaso Active and its officers and directors. 13 In August and September 2004, Vaso Active and its former Chief Executive Officer, John Masiz, settled all SEC and U.S. District Court matters regarding our alleged violations of securities laws stemming from allegedly misleading disclosures in our initial public offering registration statement, our 2003 annual report and a statement on our website concerning the FDA's approval or qualification of our products. Both Vaso Active and Mr. Masiz agreed with the SEC to settlement terms without admitting or denying the allegations of their civil complaint, pursuant to which both parties are permanently enjoined from violating the anti-fraud provisions of the 1933 Act, and the antifraud and reporting provisions of the 1934 Act. Our former Chief Executive Officer was also prohibited from serving as an officer or director of any public company, including Vaso Active, for a period of five years. He is, however, permitted to remain an active employee/consultant of Vaso Active. Since August 2004, Mr. Masiz has been employed by Vaso Active to provide consulting services pursuant to the terms of his employment agreement with the company. Also during 2004, together with newly engaged outside FDA counsel, we revised our product labels and in September began shipping our products on a limited basis. Although these products are now on the market, we have not made significant shipments or recorded significant revenues to date. On June 1, 2005, Vaso Active entered into a Memorandum of Understanding Concerning Settlement Terms ("MOU") to settle the consolidated securities class action lawsuit styled In Re VASO ACTIVE PHARMACEUTICALS SECURITIES LITIGATION, Master Docket No. 04-10708-RCL (D. Mass). Under the terms of the MOU, the lead plaintiffs and the settling defendants agree that the final stipulation will contain a disclaimer of liability consistent with the MOU. Subject to the terms and conditions set forth in the MOU, settling defendants will pay into escrow for the benefit of the class $1,100,000 in cash and $750,000 face amount of 2-year 5% subordinated callable notes convertible at $1.75 per share within 10 business days of preliminary approval of the settlement by the court. In consideration of this payment, the parties will fully and finally release and discharge all claims against each other. The settlement still needs court approval. Our insurance carrier has agreed to pay the $1,100,000 cash payment in exchange for a release of its liability under its insurance policy with us. We recorded a charge of $750,000 during the three-month period ended June 30, 2005 in connection with this settlement. We intend to record the 2-year 5% subordinated callable notes when we receive a final settlement by the court. The above settlement does not cover the three derivative shareholder actions filed against Vaso Active's directors, certain officers and against BioChemics. You should refer to "Legal Proceedings" and "Risk Factors" for additional discussions surrounding these events. Many of our resources, including our cash and management time, have been diverted from our business strategy addressing these legal matters. We have incurred significant costs in defending ourselves. We have primarily used the cash we raised in our December 2003 initial public offering to pay for these costs. In addition, in April 2004, we repaid all of the approximately $7.5 million in cash we raised in the private placement during March 2004. We had initially intended to use the December 2003 and March 2004 offering proceeds to further our working capital and expand our business and marketing plans. The success of our marketing and sales activities will be dependent, among other things, on our ability to retain and attract qualified marketing and sales personnel, enter into qualified strategic partnerships, and place our products into the market, the consumer perception of our products and the securing of additional financing. Although we believe that our products, supported by sufficient advertising, will earn retailers acceptance, there be no assurance that this will happen, or if it does, that it will continue. Our independent auditors stated in their "Report of Independent Registered Public Accounting Firm" on our financial statements as of and for the years ended December 31, 2004, 2003 and 2002 that we may be unable to continue as a going concern. On August 16, 2005, we netted approximately $1,700,000 from the sale of Notes. See "LIQUIDITY AND CAPITAL RESOURCES" section of Management Discussion and Analysis for further discussion of the sale of the Notes. We believe that we can resume the commercializing, marketing and selling of our current products and continue the development of our current product candidates through May 31, 2006 with the net proceeds from this financing. Although we believe the proceeds of this financing will sustain our current operations through May 31, 2006, we believe that we will require additional capital financing to adequately fund our operations in the near future. We can provide no assurances that such capital financing will be available to us or that, if available, will be at commercially reasonable terms. 14 TECHNOLOGY OVERVIEW Transdermal drug delivery is generally considered to be any process of delivering drugs through the skin and into the bloodstream without the use of an invasive instrument such as a needle. We believe that transdermal drug delivery offers potential advantages over other commonly accepted modes of drug delivery for the treatment of certain diseases and medical conditions. We believe that these potential advantages include: REDUCTION OF ROUTE-OF-ADMINISTRATION RELATED SIDE EFFECTS. Because hey are absorbed through the stomach, some orally administered medicines can cause significant gastrointestinal side effects, sometimes leading to discontinuation of the medication. There also may be side effects associated with the delivery of some drugs through the nasal lining, the lungs, and the skin using traditional methods. The goal of the VALE transdermal delivery system is to provide effective therapy while minimizing side effects. IMPROVED DRUG PERFORMANCE. Transdermal formulations may have the potential to improve the effectiveness of a drug by avoiding the stomach and the first-pass metabolism associated with oral delivery of drugs. Transdermal drug delivery also may have the potential to create a higher bioavailability index for certain drugs, allowing for the desired concentration of the drug molecule to reach the bloodstream from a smaller dose of drug applied to the patient. Bioavailability index is defined as the fraction of the drug amount administered that reaches the central circulation. By definition, bioavailability for a drug administered intravenously is 100% and drugs administered by other methods will typically have bioavailability indices of less than 100%, depending on the efficiency of drug transfer into the blood. There are many different technologies used to deliver drugs transdermally. The most common technologies employed are: (i) patches that adhere to the skin, holding a drug in place while it is administered over time; (ii) liposome, or artificially prepared cell-like structures, which are applied topically and absorbed; or (iii) an outside energy source producing electricity (iontophoresis), or sound (sonophoresis), to help move the drug through the various skin layers. We believe all three of these technologies have certain drawbacks that may limit their utility. We believe that Vaso Active's formulation technologies can be applied to a significant array of currently off-patent drugs for commercialization in the OTC marketplace. The VALE technology is a transdermal formulation that we believe may have the potential to introduce drugs through the skin and into the bloodstream in an efficient and effective manner. The PENtoCORE technology is a topical formulation that we believe allows for the formation of OTC products with certain "use advantages" over similar products marketed by our competitors. "Use advantages" include characteristics such as lack of odor, residue, and feel. THE VALE TECHNOLOGY The goal behind the development of the VALE technology is to create an active transdermal drug system that efficiently and effectively delivers drugs through the skin and into the blood supply without the need of a patch. In order to accomplish this, a delivery system must be able to overcome three skin barriers: o the outer layers, or the stratum corneum and the epidermis; o the second layer, or the dermis; and o the walls of individual capillaries. 15 The VALE technology is intended to be a patchless, lipid-based delivery system which uses an active process to deliver drugs through the skin and into the bloodstream. It is being developed around the unique concept of incorporating chemical vasodilators into the drug delivery vehicle. These chemical compounds are intended to act on the network of blood vessels located near the surface of the skin to elicit the physiologic response of dilating or relaxing the blood vessels in the immediate area. This, in turn, is designed to have the effect of increasing the blood flow to the area. The theory behind the VALE technology is that as blood flow increases and the blood vessels dilate, the active drug molecules incorporated into the delivery system are transported actively and efficiently into the bloodstream. We believe that the VALE technology has the potential to eliminate the need for a patch and to allow for the effective delivery of many active ingredients that may not otherwise be effectively delivered using existing drug delivery technologies. THE PENTOCORE TECHNOLOGY The PENtoCORE technology is a topical formulation, as opposed to the VALE transdermal technology. Although the PENtoCORE technology does not achieve its effect by delivering the drug through the skin and into the bloodstream, we believe that this technology may enable the formulation of topical products that are pleasant to use because they do not have the odor, greasy feel or residue often associated with other topically-applied drug products. In addition, it may be possible to use the PENtoCORE technology with certain active ingredients to develop topical formulations that may facilitate a longer-lasting effect. MANUFACTURING AND DEVELOPMENT AGREEMENT In August 2003, we formalized a manufacturing and development agreement with BioChemics (the "Agreement") with respect to the ongoing manufacturing and development of our products and product candidates. The Agreement has an initial term of five years and shall be automatically renewed on each anniversary date of the agreement for an additional period of 12 months so long as the Agreement has not been terminated in acccordance with its terms and conditions. Under this agreement, BioChemics has and will continue to research, develop and manufacture products for us pursuant to specific purchase orders submitted by us from time to time. BioChemics will charge us a development and manufacturing fee at a rate of cost plus 10%. The Agreement permits BioChemics to use third party contractors to manufacture the products that BioChemics provides to us. Currently, BioChemics uses a privately owned third party company as its sole contract manufacturer. We do not currently, nor do we intend to, engage in the manufacturing of, nor conduct any research and development with respect to, any of our products or product candidates. However, in the event that BioChemics is unwilling or unable to meet our manufacturing needs in accordance with the terms of the Agreement with us, we have the right to retain outside third parties to manufacture our products. Pursuant to this Agreement, during the three-month periods ended March 31, 2005 and 2004, we incurred research and development costs of $90,030 and $95,167, respectively, related to the formulation of an analgesic utilizing the active ingredient ibuprofen. Pre-clinical studies utilizing animals were conducted and billed as part of this research. ADMINISTRATIVE AND MANAGERIAL SUPPORT Effective September 1, 2003, we entered into an administrative services Agreement with BioChemics. Under this agreement, BioChemics provides to us, at our request, administrative support services including secretarial support, accounting and tax services, data processing services, utilities, designated office space, designated warehouse and storage space, office supplies, telephone and computer services and equipment and such other office and corporate support services as we may reasonably require from time to time. BioChemics charges us an administrative services fee at a rate of cost plus 10%. This agreement is in effect for an initial term of 5 years and will be automatically renewable on each anniversary date for an additional period of 12 months unless sooner terminated (i) for a material breach by us, not cured within three months, and 16 upon written notice (ii) upon 30 days written notice by us, (iii) upon 45 days written notice by either party if BioChemics ceases to own beneficially shares of our capital stock to which are attached at least 49% of the votes that may be cast to elect our Directors, or (iv) upon written notice by either party in the event that we shall have disposed of all or substantially all of our assets. Pursuant to this agreement, since BioChemics provides us with administrative and managerial support, our results of operations include allocations of certain BioChemics expenses, such as centralized accounting, data processing, utilities, office space rental, supplies, telephone and other BioChemics corporate services and infrastructure. These expenses have been charged back to us as a management fee. The expense allocations have been determined on the basis that we and BioChemics consider to be reasonable reflections of the utilization of services provided for the benefit received by us. GOVERNMENT REGULATION GENERAL The development, testing, manufacture, labeling, marketing, and promotion of OTC drugs are subject to extensive regulation by the FDA under the Federal Food, Drug and Cosmetics Act ("FFDCA"), and by the Federal Trade Commission, or FTC, under the Federal Trade Commission Act ("FTC Act"). The degree of regulation under the FFDCA is dependent, in part, upon whether the OTC drug, as formulated, labeled, and promoted, is considered by qualified experts, based on publicly available scientific data and information, to be generally recognized as safe and effective ("GRASE"), for its recommended conditions of use. If an OTC drug as formulated, labeled, and promoted is not considered GRASE for its recommended conditions of use or, if so considered, if it has not been used to a material extent or for material time, the drug is regulated under the FFDCA as a "new drug" which requires pre-market approval in the form of a New Drug Application, or NDA, before it can be commercially marketed. To determine which OTC drugs are GRASE, the FDA has undertaken a rulemaking initiative in which it seeks to define by regulation which OTC drugs can be considered to be GRASE and thus can be marketed without first obtaining an approved NDA. This rulemaking initiative, referred to as the "OTC Review Program," was initiated on May 11, 1972, and is ongoing. The OTC Review Program sets forth in the form of an OTC Drug Monograph for specific categories of OTC drugs (e.g., Topical Anti-Fungal OTC drugs) the conditions under which recognized OTC active ingredients can be considered GRASE and not misbranded. These conditions include the strength of the active ingredient, acceptable dosage forms, the use of safe and suitable inactive ingredients, and the recommended conditions of use, including indications, warnings, precautions, and directions for use. If the active ingredient used in an OTC drug is not covered by the OTC Review Program, or even if it is covered, if the conditions of use (e.g., strength, dosage form, indications) deviate from that eligible for GRASE status under the OTC Review Program, the product is considered by the FDA to be a "new drug" subject to the NDA pre-market approval requirements. For a full discussion of these requirements see the discussion below in "NDA Review Process". Pending the issuance of a final and effective OTC Drug Monograph for the category of OTC drug involved (e.g., external analgesic), the FDA has adopted an enforcement policy of not proceeding against the continued marketing of OTC drugs subject to the OTC Review Program. This enforcement discretion does not, however, apply if: (a) the FDA considers the drug product involved as falling outside of the scope of the OTC Review Program in that the active ingredient or conditions of use deviate from those eligible for GRASE status 17 under the OTC Review Program; (b) the product presents a health hazard; or (c)the active ingredient at the dosage level involved was not available OTC prior to December 4, 1975. The FDA's willingness to defer enforcement action generally terminates upon the effective date of the final OTC Drug Monograph covering the applicable drug product. Other requirements or limitations for OTC drugs imposed under the FFDCA include: (a) a requirement that the drug be manufactured in conformity with current good manufacturing practices, or cGMPs; (b) a requirement that the labeling for the product contain adequate directions for use and warnings; (c) a requirement that the manufacturer of the drug product register with the FDA; (d)a requirement that all drugs manufactured for commercial distribution be listed with the FDA; and (e) a prohibition against making any false or misleading misrepresentations in any particular in any labeling for the product. As noted above, OTC products marketed in accordance with OTC Drug Monographs do not require FDA premarket approval prior to marketing. If an OTC product deviates from an OTC Drug Monograph requirement in active ingredient(s), intended use, method of administration, dosage form, or labeling, among other things, then the manufacturer or distributor must obtain pre-market approval in the form of an NDA before commercial marketing. The failure to adhere to the requirements of the FFDCA can result in: (a) seizure of violative products; (b) injunctions against continued violations of the FFDCA, including active FDA supervision in instituting appropriate corrective action and prohibition against continued marketing of the violative products pending an affirmative determination by the FDA and the courts that the violations have been adequately rectified; (c) civil penalties in the form of liquidated damages and/or recovery of profits from illegal activities; and (d) the imposition of criminal sanctions and penalties against responsible persons. The FTC, under the FTC Act, regulates print and broadcast media advertisements for OTC drugs. The FTC Act requires that advertisements be neither false nor misleading and that claims for products purportedly based on scientific data be supported by adequate and well controlled studies and that a reasonable basis exists in support of all other claims. Claims consistent with the terms of an OTC Drug Monograph are usually accepted by the FTC as having been adequately substantiated. The penalties for the failure of an advertised claim to have adequate substantiation, or for claims that are false and misleading, include: (a) the FTC initiating administrative action for consumer redress; (b) FTC seeking a court injunction to prevent further false and misleading advertising; (c) the imposition by a court of liquidated damages and equitable relief to recover profits and provide consumer redress from illegal activity; and (d) the placing of the company in receivership to assure that the assets of the company are not dissipated pending resolution of FTC claims. THE NDA REVIEW PROCESS The FDA has taken the position that insofar as our products or product candidates use a transdermal technology, the products fall outside that eligible for GRASE status under the OTC Review Program and thus the Company must obtain NDA approval of the products before they can be commercially marketed. Under the FDA's procedures it is generally less burdensome to obtain NDA approval of a drug product which contains active ingredient(s): (a) considered GRASE in a final OTC Drug Monograph, or (b) contained in a drug product eligible for an abbreviated new drug application, or ANDA, approval, but which differs in certain conditions of use (e.g., dosage form) from that covered by a final OTC Drug Monograph or eligible for ANDA approval. However, once a product becomes subject to the NDA requirements, the general provisions of which are set forth below, there can be no assurance that a company can generate the additional data and information necessary to support NDA approval of the proposed variant product or that approval can be obtained without substantial expenditures and delays. The steps ordinarily required before a new drug that is subject to NDA approval may be marketed in the United States include preclinical laboratory tests, animal tests and formulation studies, the submission to the FDA of an investigational new drug application, or IND, which must become effective before clinical testing may commence, and adequate and well-controlled clinical trials on human subjects to establish the safety and effectiveness of the drug for each indication for which FDA approval is sought. Satisfaction of FDA pre-market approval requirements typically takes several years and the actual time required may vary substantially based upon the type, complexity and novelty of the product or the disease or condition for which the new drug is indicated. 18 Government regulation may delay or prevent marketing of potential products for a considerable period of time and impose costly procedures upon a manufacturer's activities. Success in early-stage clinical trials does not assure success in later stage clinical trials. Data obtained from clinical activities is not always conclusive and may be susceptible to varying interpretations that could delay, limit, or prevent regulatory approval. Even if a product receives regulatory approval, later discovery of previously unknown problems with a product may result in restrictions on the product or even complete withdrawal of the product from the market. Preclinical tests include laboratory evaluation of product chemistry and formulation, as well as animal trials to assess the potential safety and efficacy of the product. The conduct of the preclinical tests and formulation of compounds for testing must comply with Federal regulations and requirements. The results of preclinical testing are submitted to the FDA as part of an IND. A 30-day waiting period after the filing of each IND is required prior to the commencement of clinical testing in humans. If the FDA has not commented on or questioned the IND within this 30-day period, clinical trials may begin. If the FDA has comments or questions, the questions must be answered to the satisfaction of the FDA before initial clinical testing can begin. In addition, the FDA may, at any time, impose a clinical hold on ongoing clinical trials. If the FDA imposes a clinical hold, clinical trials cannot commence or recommence without FDA authorization and then only under terms authorized by the FDA. In some instances, the IND process can result in substantial delay and expense. Clinical trials typically involve the administration of the investigational new drug to volunteers or patients under the supervision of a qualified investigator. Clinical trials must be conducted in compliance with Federal regulations and requirements, under protocols detailing the objectives of the trial, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. Each protocol involving testing on U.S. subjects must be submitted to the FDA as part of the IND. The study protocol and informed consent information for patients in clinical trials must also be approved by the institutional review board at each institution where the trials will be conducted. Clinical trials to support NDAs for marketing approval are typically conducted in three sequential phases, but the phases may overlap. In Phase I, the initial introduction of the drug into healthy human subjects or patients, the drug is tested to assess metabolism, pharmacokinetics and pharmacological actions and safety, including side effects associated with increasing doses. Phase II usually involves trials in limited patient populations, to determine dosage tolerance and optimum dosage, identify possible adverse effects and safety risks, and provide preliminary support for the efficacy of the drug in the indication being studied. If a compound demonstrates evidence of effectiveness and an acceptable safety profile in Phase II evaluations, Phase III trials are undertaken to further evaluate clinical efficacy and to further test for safety within an expanded patient population, typically at geographically dispersed clinical trial sites it is possible that Phase I, Phase II, or Phase III testing of product candidates may not be completed successfully within any specified time period, if at all. After successful completion of the required clinical testing, generally an NDA is prepared and submitted to the FDA. FDA approval of the NDA is required before marketing of the product may begin in the United States. The NDA must include the results of extensive clinical and other testing and a compilation of data relating to the product's pharmacology, chemistry, manufacture, and controls. The cost of preparing and submitting an NDA is substantial. Under federal law, the submission of NDAs are additionally subject to substantial applications user fees, currently exceeding $500,000, and the manufacturer and/or sponsor under an approved NDA are also subject to annual product and establishment user fees, currently exceeding $30,000 per product and $200,000 per establishment. These fees are typically increased annually. 19 The FDA has 60 days from its receipt of an NDA to determine whether the application will be accepted for filing based on the agency's threshold determination that the NDA is sufficiently complete to permit substantive review. Once the submission is accepted for filing, the FDA begins an in-depth review of the NDA. Under federal law, the FDA has agreed to certain performance goals in the review of NDAs. Most applications for non-priority drug products are reviewed within ten months. The review process is often significantly extended by FDA requests for additional information or clarification of information already provided in the submission. The FDA may also refer applications for novel drug products or drug products which present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians and other experts, for review, evaluation, and a recommendation as to whether the application should be approved. The FDA is not bound by the recommendation of an advisory committee. If FDA evaluations of the NDA and the manufacturing facilities and procedures, which typically involves an FDA on-site inspection, are favorable, the FDA may issue an approval letter, or, in some cases, an approvable letter followed by an approval letter. An approvable letter generally contains a statement of specific conditions that must be met in order to secure final approval of the NDA. If and when those conditions have been met to the FDA's satisfaction the FDA will typically issue an approval letter. An approval letter authorizes commercial marketing of the drug with specific prescribing information for specific indications. If the FDA's evaluation of the NDA submission or manufacturing facilities is not favorable, the FDA may refuse to approve the NDA or issue a not approvable letter. The not approvable letter outlines the deficiencies in the submission and often requires additional testing or information in order for the FDA to reconsider the application. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval. With limited exceptions, FDA may withhold approval of an NDA regardless of prior advice it may have provided or commitments it may have made to the sponsor. As a condition of NDA approval, the FDA may require post-approval testing and surveillance to monitor the drug's safety or efficacy and may impose other conditions, including labeling restrictions. Such labeling restrictions can materially impact the potential market and profitability of the drug. Once granted, product approvals can still be withdrawn if compliance with regulatory standards is not maintained or problems are identified following initial marketing. Once the NDA is approved, a product will be subject to certain post-approval requirements, including requirements for adverse event reporting and submission of periodic reports. Persons responsible for manufacture or distribution are subject to FDA inspections to assess compliance with applicable statutory and regulatory requirements. Additionally, the FDA also strictly regulates the promotional claims that may be made about drug products. The FDA requires substantiation of any claims of superiority of one product over another including, in many cases, requirements that such claims be proven by adequate and well controlled head-to-head clinical trials. The FTC Substantiation Standards are very similar for the advertising of OTC products. To the extent that market acceptance of the Company's products may depend on their superiority over existing therapies, any restriction on the Company's ability to advertise or otherwise promote claims of superiority, or requirements to conduct additional expensive clinical trials to provide proof of such claims, could negatively affect the sales of the Company's products and/or the Company's costs. CURRENT PRODUCT LINE We have completed the development and test marketing of our three primary products. Each of these products uses the PENtoCORE technology. These products are: o Osteon - an OTC external analgesic designed to provide temporary relief from the muscular-skeletal pain associated with arthritis; 20 o A-R Extreme - an OTC external analgesic designed to provide temporary relief from the muscle and joint pain associated with athletic activity; and o Termin8 - an OTC antifungal lotion designed to effectively treat athlete's foot. We license the Osteon and PENtoCORE trademarks under our amended license agreement with BioChemics. We market each of our three current principal products under the OTC Review Program. You should refer to the discussions in "Government Regulation" in our 2004 Annual Report on Form 10-KSB filed with the SEC on March 31, 2005 for more detailed information surrounding impact FDA regulations have on our business. PRODUCT CANDIDATES In addition to and separate from our A-R Extreme, Osteon and Termin8 products, we have identified and are currently developing, in collaboration with BioChemics, six additional OTC product candidates that will utilize the VALE transdermal or PENtoCORE topical technology. Each of these product candidates are in various stages of development and are not yet available for sale. These product candidates are as follows: o An analgesic utilizing ibuprofen; o Toenail fungus treatment; o Acne treatment; o First aid treatments; o Hand and body lotions; and o Psoriasis treatment. Each of our OTC product candidates are subject to FDA regulations. With regard to these product candidates, in instances where the active ingredient (e.g., ibuprofen), dosage form (e.g., VALE transdermal technology), strength, route of administration, directions for use or indication (e.g., toenail fungus) of the product candidate is not covered by the OTC Review Program or where the inactive ingredients used in the product candidate are not recognized as safe and suitable for their intended OTC use, we cannot market the product candidate without obtaining pre-market approval in the form of an approved new drug application, or NDA or an abbreviated new drug application, or ANDA. Conversely, where we believe the active ingredient, dosage form, strength, route of administration, directions for use, and indication of the product candidate are covered by the OTC Review Program and the inactive ingredients used in the product candidate are safe and suitable for their intended OTC use, the product candidate could be marketed without obtaining NDA or ANDA clearance, provided it conforms to the applicable OTC Monograph and is not otherwise adulterated or misbranded. You should refer to the discussions in "Product Candidates" in our 2004 Annual Report on Form 10-KSB filed with the SEC on March 31, 2005 for more detailed information surrounding impact FDA regulations have on our product candidates. We have finalized a formulation of our acne treatment utilizing our PENtoCORE topical technology. We intend to market the acne treatment under the label RepiDerm(R). The product would contain 10% benzoyl peroxide, or BPO, as an active ingredient. You should refer to the discussions in "Product Candidates" in our 2004 Annual Report on Form 10-KSB filed with the SEC on March 31, 2005 for more detailed information surrounding the FDA's concerns surrounding the safety of BPO and the related impact these concerns have on the future marketing and sale of RepiDerm. COMPETITION We are engaged in a rapidly evolving field. We compete primarily with established pharmaceutical companies like Pfizer, Bristol-Myers Squibb Schering-Plough, and Alza, and emerging biotechnology companies like Cygnus and Elan, as well as research and academic institutions, among others. Competition is intense and expected to increase. 21 The large and rapidly growing market for transdermal and topical drug delivery systems is likely to attract new entrants. Numerous biotechnology and biopharmaceutical companies are focused on developing new drug delivery systems and most, if not all, of these companies have greater financial and other resources and development capabilities than we do. Our competitors also have greater collective experience in undertaking pre-clinical and clinical testing of products, obtaining regulatory approvals and manufacturing and marketing OTC and prescription pharmaceutical products. Accordingly, certain of these competitors may succeed in obtaining approval for products more rapidly than us. In addition to competing with universities and other research institutions in the development of products, technologies and processes, we may compete with other companies in acquiring rights to products or technologies from universities. There can be no assurance that our products or product candidates will be more effective or achieve greater market acceptance than competitive products, or that these companies will not succeed in developing products and technologies that are more effective than those being developed by us or that would render our products and technologies less competitive or obsolete. Although we consider the PENtoCORE technology proprietary, the PENtoCORE products, which represent all our current products, do not enjoy any patent protection. This may allow our competitors to imitate or reverse engineer our current products and use their greater manufacturing and marketing resources to rapidly promulgate competing versions. It is our opinion that competing topical and transdermal delivery technologies using patches, liposomes, and equipment-assisted deliveries such as iontophoresis and sonophoresis have some utility with a small group of select drugs. It is our opinion, however, in general, that these drug delivery systems are not useful for most drugs. Our success will depend on our ability to leverage the PENtoCORE and VALE technologies to achieve market share at the expense of our existing and future competitors who we believe cannot offer products utilizing a delivery system of comparable performance characteristics. In addition to competing with newly developed drug delivery systems, we will compete with existing products which address the same medical conditions as our products and product candidates. For instance, Tinactin(R) and Lotrimin(R) would compete with our Termin8 athlete's foot product, while Advil(R) and Tylenol(R) would compete with our pain relief products and product candidates. These and other brands are already offering different delivery systems. For instance, Pfizer's Ben Gay(R) is now offered in a patch as well as a cream. These products are manufactured, distributed and marketed by companies with vastly greater resources than our own. There is no guarantee we will be able to achieve widespread market acceptance for our products, or that our marketing efforts will be successful in distinguishing our products from these established market participants. DISTRIBUTION Recent regulatory events and securities claims brought against us and our management has placed strains on our management and capital resources. As a result of the cessation of the marketing and sale of our products in early 2004 and changes in the timing for the retail rollout of our products, we do not anticipate using any of our 2003 initial public offering proceeds to fund our advertising, direct mail programs and related promotional activities. You should refer to the discussions under the caption "Legal Proceedings" for further discussion on our cessation of marketing and sales activities. NEW DEVELOPMENTS - IN early 2004, we suspended the marketing and sale of our products until we were reasonably sure that our product marketing was consistent with the FDA's requirements and policies. In May 2004, together with outside FDA counsel, we revised our product labels and in September 2004 began shipping our products on a limited basis. Although these products are now on the market, we have not made significant shipments to date. 22 We intend to begin distribution our current products into major retail and drug store chains, select independent pharmacies and nontraditional channels, including multilevel marketing, direct marketing, web-sites and catalogues. On July 20, 2005 the Company entered into an exclusive brokerage agreement with Ferolie Corporation d/b/a Eastern Sales & Marketing (ESM), of Montvale, New Jersey to sell all of Vaso Active's products across all classes of retail trade in the Continental United States. In addition, under the agreement, ESM will be Vaso Active's non-exclusive agent to identify prospective licensees of its trademarks and trade names. ESM is a full-service sales, marketing and merchandising agency that provides comprehensive services for consumer packaged goods manufacturers in various product categories, including food, drug, specialty and private label. The agreement is effective August 1, 2005 for an initial period of one year. Excluded from the agreement are direct response sales, medical and professional sales, and internet sales. We expect to begin shipping through ESM channels before the end of 2005. The actual timing of beginning shipments may be delayed because package design might be changed for our existing products. In addition the timing for new products to be introduced into retail is dictated by the planning schedule of the individual chains. Early in 2005 we launched a nationwide direct-to-consumer marketing campaign for Osteon that consisted of two versions of sixty second television commercials. Due to lack of working capital we suspended purchasing television commercials. We expect to resume running television commercials in September. In August we entered into a pay-per-unit of sale arrangement to purchase television commercials. We are negotiating additional pay-per-unit of sale arrangements. These arrangements are designed to run our commercials in remnant, or unsold, television commercial space. The Company pays a predetermined amount per unit of Osteon sold. In addition we plan to use portions of the proceeds raised from our August 16, 2005 sale Notes to purchase additional television commercial space to augment the pay-per-unit of sale program. During 2004, we executed a strategic alliance with Ortho Distribution Inc. or ODI. In January 2005 ODI's parent company was purchased by an unrelated third-party. ODI Management, under the new ownership, has not pursued the alliance as strongly as prior management. We are no longer in negotiations with management. To date we have not made any sales under this relationship and we do not expect future sales, if any, to be significant. Product previously manufactured and labeled by the Company for ODI has been written off in the previous quarter. Under our strategic alliance with M2G Media we have been in discussions with respect to launching our acne product, RepiDerm. These discussions have not led to an agreement and we presently do not expect any significant sales of our acne product RepiDerm through M2G Media. TRANSACTIONS WITH BIOCHEMICS In February 2003, BioChemics granted us an exclusive, irrevocable, worldwide license to use and practice the VALE patents and PENtoCORE technology in order to commercialize, market and sell OTC pharmaceutical products. The license agreement with Biochemics is limited to OTC products each costing less than $1,000,000 to develop. We expect that our OTC topical analgesic utilizing ibuprofen product candidate will cost more than $1,000,000 to develop. Based on informal discussions with Biochemics, we expect to amend our licensing agreement to include OTC ibuprofen regardless of its development cost. 23 We have an agreement with BioChemics whereby BioChemics provides to us, at our request, administrative support including secretarial support, accounting and tax services, data processing services, utilities, designated warehouse, office and storage space, office supplies, telephone and computer services and equipment and such other office and corporate support services we may reasonably require from time to time. Our administrative services agreement with BioChemics is set to expire in September 2008 with automatic 12-month renewal terms provided the agreement is not terminated in accordance with its terms and conditions. We have an agreement with BioChemics whereby BioChemics manufactures and develops our current products and product candidates. We do not currently, nor do we intend to, engage in the manufacturing of, nor conduct any research and development with respect to, any of our products or product candidates. We are in the business of commercialization, marketing and selling OTC pharmaceutical products that incorporate topical and transdermal formulation platforms. Our manufacturing and development agreement with BioChemics is set to expire in August 2008 with automatic 12-month renewal terms provided the agreement is not terminated in accordance with its terms and conditions. Under both agreements, BioChemics charges us fees at a rate of cost plus 10%. We believe that the fees charged to us by BioChemics are on terms as favorable as those available from non-affiliated parties. During the six-month periods ended June 30, 2005 and 2004, BioChemics charged us approximately $23,000 and $16,300, respectively, for administrative support services. During the six-month period ended June 30, 2005 and 2004, BioChemics charged us approximately $177,500 and $142,500, respectively, for manufacturing and development. The majority of those costs related to the formulation of an analgesic utilizing the active ingredient ibuprofen. OUTLOOK FOR REMAINDER OF 2005 During 2005, the Company plans to: o Expand distribution through retail channels under our brokerage agreement with ESM; o Continue the direct-to-consumer television campaign of our topical analgesic marketed under the label Osteon; o Complete package design and branding for our acne product, RepiDerm; o Increase staffing, including outbound telemarketers Our strategy for Osteon is to create, through telemarketing, advertising and mailings a customer base of senior women and men suffering from osteoarthritis. We expect re-order sales of Osteon to carry higher gross profit margins than initial order sales of Osteon because re-order sales should not require the same direct media advertising expenditures as do the initial order sales. To achieve future growth, we plan to offer additional products, to be determined, that fit the demographic of this customer base. Our strategy for AR-Extreme and Termin8 is to achieve market penetration through wholesale distribution to chain pharmacies, chiropractors, podiatrists, dermatologists, wellness and fitness centers. We are in the very early stages of this launch. We plan to use a portion of the net proceeds from the sale of the Notes to support the retail rollout of our products through ESM chanels. Our targeted September rollout of Repiderm has been delayed due to working capital constraints. We plan to use a portion of the net proceeds from the sale of the Notes to complete package design and branding for Repiderm. We previously intended to launch RepiDerm by the end of the third quarter of 2005. Our new target launch date for RepiDerm is the first quarter of 2006. We plan to package and market this product under several labels. One label will be targeted to the teenage and young adult markets and another label will target older adults. This product is formulated to treat acne based upon regular usage and we expect to realize a re-order stream with our future customers. We may market this product as direct to consumer, retail, or both. 24 CRITICAL ACCOUNTING ESTIMATES GOING CONCERN ASSUMPTION - The financial statements do not include any adjustments relating to the recoverability and classification of assets or the amounts and classification of liabilities that might be necessary should we be unable to continue as a going concern. If the financial statements were prepared on a liquidation basis, the carrying value of our assets and liabilities would be adjusted to net realizable amounts. In addition, the classification of the assets and liabilities would be adjusted to reflect the liquidation basis of accounting. REVENUE RECOGNITION - We recognize revenue from product sales in accordance with generally accepted accounting principles in the United States, including the guidance in Staff Accounting Bulletin, or SAB, No. 104, "Revenue Recognition," which superceded SAB No. 101, "Revenue Recognition in Financial Statements," and Statement of Financial Accounting Standards, or SFAS, No. 48, "Revenue Recognition When Right of Return Exists." Revenue from product sales is recognized when there is persuasive evidence of an arrangement, delivery has occurred, the price is fixed and determinable, and collectibility is reasonably assured. However, because our products are sold with limited rights of return, revenue is recognized when the price to the buyer is fixed, the buyer is obligated to pay us and the obligation to pay is not contingent on resale of the product, the buyer has economic substance apart from the us, we have no obligation to bring about the sale of the product and the amount of returns can be reasonably estimated. We record allowances for product returns, rebates and discounts, and report revenue net of such allowances. We must make judgments and estimates in preparing the allowances that could require adjustments in the future. For instance, our customers have the right to return any product that is held past the labeled expiration date. We base our estimates on historic patterns of returns and on the expiration dates of product currently being shipped, or as a result of an actual event that may give rise to a significant return amount such as the discontinuance of a product. We do not recognize revenue unless collectibility is reasonably assured. We maintain allowances for doubtful accounts for estimated losses resulting from the inability of our customers to make required payments. If the financial condition of our customers were to deteriorate and result in an impairment of their ability to make payments, additional allowances may be required. EXPENSE ALLOCATIONS / MANAGEMENT FEES - BioChemics provides us with certain administrative, marketing and management services, as well as our facilities and general corporate infrastructure. Our statement of operations includes allocations of these costs that BioChemics that we considered to be reasonable. These costs are included in selling, general and administrative expenses. INCOME TAXES - We account for income taxes and deferred tax assets and liabilities in accordance with SFAS No. 109, "Accounting for Income Taxes." Because we project future operating losses in the near term, we have provided a full valuation allowance against the deferred tax assets created by these losses. STOCK-BASED COMPENSATION - As part of our compensation programs offered to our employees, we grant stock options. We grant stock options to employees based on the fair value of the Class A common stock at the grant date. As allowed under SFAS No. 123, "Accounting for Stock-Based Compensation," and SFAS No. 148, "Accounting for Stock-Based Compensation - Transition and Disclosure," we have adopted the disclosure-only requirements of these accounting standards. Accordingly, we do not recognize stock-based compensation expense for stock options granted to employees at their fair value. The fair value of options granted to non-employees is expensed in accordance with SFAS 123 using the Black-Scholes option-pricing model. See Note 4 to our condensed financial statements for the impact on earnings had we fully adopted SFAS 123. 25 In December 2004, the FASB issued a revision to SFAS No. 123, "Share-Based Payment," requiring companies to recognize as compensation expense the fair value of stock options and other equity-based compensation issued to employees. This revised statement eliminates the intrinsic value method provided under Accounting Principles Board, or APB, No. 25, "Accounting for Stock Issued to Employees," which is the method we currently use to value stock options awarded to our employees. This revised standard is effective as of the beginning of the first annual reporting period beginning after December 15, 2005 and is expected to have a material impact on our results of operations. We are currently evaluating the two methods of adoption allowed by this revised standard; the modified-prospective transition method and the modified-retrospective transition method. THREE MONTHS ENDED JUNE 30, 2005 AND 2004 NET REVENUES - On April 8, 2004, we suspended the marketing and sale of our products until we were reasonably sure that our product marketing was consistent with the FDA's requirements and policies and that all outstanding matters had been addressed to the satisfaction of the SEC. See discussion under "Overview, Key Business Challenges and Risks." In May 2004, together with outside FDA counsel, we revised our product labels and in September 2004 began shipping our products on a limited basis. Although these products are now on the market, we have not made significant shipments to date. Net revenues increased $10,337 to $11,199 for the three month period ended June 30, 2005 as compared to $862 in the prior comparable period. However, as a result of the limited revenues during these periods, we believe net revenue comparisons are not meaningful. COST OF SALES - Cost of sales decreased $26,386 to $13,467 during the three month period ended June 30, 2005 from $39,853 in the comparable period in 2004. In general, our cost of sales is variable to our net revenues. However, certain manufacturing events such as inventory adjustments may distort our cost of sales, and therefore our gross profit, during any particular period. The $26,386 decrease in cost of sales was due primarily to a one-time charge of approximately $39,000 we incurred during the three month period ended June 30, 2004. During this period in 2004, we revised our product labels, which required us to write-off approximately $39,000 in inventory. . GROSS PROFIT - Gross profit as a percentage of net revenues for both the three month period ended June 30, 2005 and June 30, 2004 are negative as a direct result of the matters discussed under the Cost of Sales discussion above. We do not believe that any comparison between periods is meaningful in our current stage of development. MARKETING, ADVERTISING AND PROMOTION - Marketing, advertising and promotion expenses increased by $21,338 to $31,933 for the three-month period ended June 30, 2005 from $10,595 during the three-month period ended June 30, 2004. This increase was primarily due to costs associated with our launch of a series of 60 and 120 second television commercials for the Osteon product. Due to our lack of adequate working capital, we have temporarily suspended future commercial advertisements. We intend to resume broadcasting these television commercials when we receive the net proceeds from our August 2005 Senior Note financing transaction. You should refer to the discussion under "Outlook For Remainder of 2005." SELLING, GENERAL AND ADMINISTRATIVE - Selling, general and administrative expenses decreased by $592,069 to $458,805 during the three-month period ended June 30, 2005 as compared to $1,050,874 in the comparable period in 2004. In the comparable prior year period, we incurred significant non-recurring expenses, including financing fees, legal, accounting and other expenses in connection with the private placement of convertible notes in early 2004 and the subsequent unwinding of that transaction. We also incurred the following expenses in that prior year period, legal and other professional services to amend a previously filed annual report, represent ourselves to the SEC and FDA and defend ourselves in the shareholder class action and derivative law suits. You should refer to the discussions under "Overview, Key Business Challenges and Risks." We incurred approximately $19,500 in legal fees and $45,500 in business, financial and other professional services during the three month period ended June 30, 2005, as compared to approximately $519,000 in legal fees and $142,000 in business, financial and other professional services in the three-month period ended June 30, 2004. These two changes accounted for the majority of the decrease in selling, general and administrative expenses. 26 During the three months ended June 30, 2005, other selling, general and administrative expenses we incurred were $193,000 in salaries, wages and related personnel costs; approximately $51,200 for various insurance premiums typical of a public company; approximately $42,000 for board of director compensation, approximately $11,500 in management fees from BioChemics, approximately $12,200 in registered accountant fees, and approximately $10,900 in rent expense. The remaining selling, general and administrative expenses pertained to our general operations. RESEARCH AND DEVELOPMENT - Research and development expenses increased by $40,108 to $87,407 for the three-month period ended June 30, 2005 as compared to $47,299 in the comparable prior period. Beginning in January 2004, we engaged Biochemics to provide services pursuant to a February 2003 manufacturing and development agreement. These services related to the formulation of an analgesic utilizing the active ingredient ibuprofen. Expenses in this area have increased as a direct result of utilizing more of Biochemics' research and development resources during the three month period ended June 30, 2005. STOCK BASED COMPENSATION - We are required to record stock-based compensation when we grant options to purchase our common stock to non-employees in accordance with SFAS 123. The value of these options is calculated using the Black-Scholes option-pricing model. Stock based compensation for both the three-month period ended June 30, 2005 and June 30, 2004 was $15,101 and since no grants were made to non-employees during these periods, the amount recorded was attributable to the normal amortization of fair value of these awards into expense over the vesting period of the awards. LEGAL SETTLEMENT - On June 1, 2005, we entered into an MOU to settle the consolidated securities class action lawsuit. We recorded a charge of $750,000 during the three-month period ended June 30, 2005 in connection with this settlement. See discussion under "Overview, Key Business Challenges and Risks." SIX MONTHS ENDED JUNE 30, 2005 AND 2004 NET REVENUES - Net revenues increased $7,787 to $15,796 for the six month period ended June 30, 2005 as compared to $8,009 in the prior comparable period. However, as a result of the limited revenues during these periods, we believe net revenue comparisons are not meaningful. COST OF SALES - Cost of Sales decreased $25,913 to $19,715 during the six month period ended June 30, 2005 from $45,628 in the comparable prior period. In general, our cost of sales is variable to our net revenues. This decrease was due primarily to one-time charges we incurred in 2004 of $39,000 related to the write-off of unrecoverable inventory. GROSS PROFIT - Gross profit as a percentage of net revenues for both the six month period ended June 30, 2005 and June 30, 2004 are negative as a direct result of the matters discussed under the Cost of Sales discussion above related to the expiration of products and submission of new labels to the FDA. We do not believe that any comparison between periods is meaningful in our current stage of development. MARKETING, ADVERTISING AND PROMOTION - Marketing, advertising and promotion expenses increased $124,887, or approximately 163%, to $201,736 for the six-month period ended June 30, 2005 from $76,849 for the six-month period ended June 30, 2004. This increase was primarily attributable to $103,775 in costs we incurred in connection with our launch of a series of 60 and 120 second television commercials for the Osteon product throughout the United States. Costs for marketing, advertising and promotion were significantly less in 2004 as we committed on April 8, 2004 not to market or sell our products until all outstanding matters have been addressed to the satisfaction of the SEC and until we were reasonably sure that the marketing and sale of our products was consistent with the FDA's requirements and policies. See discussion under "Overview, Key Business Challenges and Risks" 27 SELLING, GENERAL AND ADMINISTRATIVE - Selling, general and administrative expenses decreased by $1,446,521 to $1,142,346 during the six-month period ended June 30, 2005 as compared to $2,588,867 in the comparable period in 2004. In the comparable prior year period, we incurred significant legal and other professional services to amend a previously filed annual report, represent ourselves to the SEC and FDA and defend ourselves in the shareholder class action and derivative law suits. See discussion under "Overview, Key Business Challenges and Risks." We incurred approximately $145,296 in total combined legal fees and $134,670 in business, financial and other professional services during the six month period ended June 30, 2005, as compared to approximately $889,000 in total combined legal fees, $286,000 in business, financial and other professional services and $615,000 in professional and settlement fees we incurred in connection with our March 16, 2004 Private Investment in Public Entity transaction during the six-month period ended June 30, 2004. These differences accounted for the majority of the decrease in selling, general and administrative expenses. During the six-months ended June 30, 2005, other selling, general and administrative expenses we incurred were $396,320 in salaries, wages and related personnel costs; approximately $118,450 for various insurance premiums typical of a public company; approximately $108,000 for board of director compensation, approximately $23,000 in management fees from BioChemics, approximately $62,200 in registered accountant fees, approximately $30,000 in computer consulting services, approximately $36,125 in travel and entertainment and approximately $21,900 in rent expense. The remaining selling, general and administrative expenses pertained to our general operations. RESEARCH AND DEVELOPMENT - Research and development expenses increased by $34,971 to $177,437 for the six-month period ended June 30, 2005 as compared to $142,466 in the comparable prior period. Beginning in January 2004, we engaged Biochemics to provide services pursuant to a February 2003 manufacturing and development agreement. These services related to the formulation of an analgesic utilizing the active ingredient ibuprofen. Expenses in this area have increased as a direct result of utilizing more of Biochemics' research and development resources during the six month period ended June 30, 2005. STOCK BASED COMPENSATION - We are required to record stock-based compensation when we grant options or warrants to purchase our common stock to non-employees in accordance with SFAS 123. The value of these options and warrants is calculated using the Black-Scholes valuation model. Stock based compensation for the six-month period ended June 30, 2004 included the award of a warrant to purchase 225,000 shares of common stock. As this warrant was completely vested, we recorded a charge of approximately $96,000 during the six month period ended June 30, 2004. The remainder of the stock-based compensation in both periods was attributable to the normal amortization of the fair value of these awards into expense over the vesting period of the awards. LEGAL SETTLEMENT - On June 1, 2005, we entered into an MOU to settle the consolidated securities class action lawsuit. We recorded a charge of $750,000 during the six-month period ended June 30, 2005 in connection with this settlement. See discussion under "Overview, Key Business Challenges and Risks." LIQUIDITY AND CAPITAL RESOURCES The Company has incurred substantial operating losses and negative cash flows from operations since inception. In 2004 and 2005, operations were financed from the proceeds of our December 2003 initial public offering. Net of offering costs, we raised approximately $6.4 million. Prior to our receipt of these proceeds, we relied on BioChemics, together with the proceeds from an offering of convertible notes in early 2003. as the source of our working capital. All of the funds raised from this initial public offering have been exhausted to date. At August 19, 2005, we had cash of approximately $1,900,000 and working capital of approximately $1,600,000. Our financial condition has been materially and adversely affected by recent regulatory and shareholder actions taken against us. On August 16, 2005, we issued a series of Senior Secured Convertible Notes (the "Notes") due May 01, 2007 in the aggregate principal amount of $2,500,000. The company netted approximately $1,700,000 in cash proceeds, after taking into consideration placement fees, legal expenses, other offering costs, and escrow deposit, from this financing. Placement fees, legal expenses and other offering costs paid were approximately $360,000 and approximately $440,000 was placed into escrow to fund substantially all of the Company's interest payments on the Notes. The Notes are secured by substantially all of our assets and is senior to all our debts. The Notes are convertible into Class A Common Stock. The Notes bear interest at the six month LIBOR plus 6.0%, with a floor of 10.0% and a ceiling of 12.0%. The initial interest rate is 10%. The notes mature on May 01, 2007 and may be paid in cash or converted into Class A Common Stock at a conversion price of $0.70 per share. Under the terms of the Notes, the note holders may exercise an additional investment right (the "AIR") to purchase up to a total of an additional $1,875,000 in principal amount of Senior Secured Convertible Notes due May 1, 2007 under substantially the same terms and conditions as the Notes. Net of placement fees, legal expenses, other offering costs and escrow deposit, we believe that we would net approximately $1,300,000 if the AIR is exercised in full. 29 If exercised in full, we believe, based on our current plans and assumptions relating to our operations, that the additional working capital provided by the exercise will be sufficient to satisfy our cash requirements through December 31, 2006. There can be no assurance that any of the AIR will be exercised. There can be no assurance that we will be able to obtain any additional financing or that, even if we do obtain additional financing, it will be on terms favorable to us. Further, there can be no assurance that we will be able to generate profitability and cash flows from operations with our existing working capital. We anticipate, based on our current plans and assumptions relating to our operations, that our current working capital will be sufficient to satisfy our cash requirements through May 31, 2006. We intend to continue as a going concern. We expect to use portions of our working capital to continue defending ourselves in the three pending shareholder derivative actions for the balance of 2005. However, we cannot reasonably estimate the total costs to defend ourselves at this time. Further, we cannot provide any assurances that we will prevail in defending ourselves from the shareholder derivative actions taken against us. In addition, our management intends to contest a substantial portion of the accounts payable shown on the Balance Sheet at June 30, 2005. In March 2004, we entered into a private placement transaction with an institutional investor in the amount of $7,500,000. The investment was in the form of an 18 month 2% Convertible Note convertible into shares of Class A common stock at a conversion rate of $9.00 per share, at the option of the investor. Both principal and interest were payable in cash or in shares of Class A common stock at our option. Given that the initiation and continuation of the April 1, 2004 trading suspension by the SEC constituted a breach under the Note, we and the investor agreed, pursuant to the terms of a settlement agreement entered into on April 8, 2004, that we would immediately repay the investor the sum of $7,500,000 in cash without penalty, interest, redemption premium or any other premium or penalty, plus an expense reimbursement in connection with the settlement agreement in the amount of $15,000 in cash. In consideration of this repayment, the investor surrendered the Note and warrants and the parties mutually terminated all other agreements entered into in connection with the transaction. We intended to use these proceeds to further our working capital and expand our business and marketing plans. CONTRACTUAL OBLIGATIONS AND COMMITMENTS The following table sets forth our contractual obligations and commitments for the next five years, as of June 30, 2005. LESS THAN 1 - 3 3 - 5 5 - 7 TOTAL 1 YEAR YEARS YEARS YEARS ---------- ---------- ---------- ---------- ---------- Long-term debt $ -- $ -- $ -- $ -- $ -- Capital lease obligations 15,148 2,316 5,070 7,762 -- Operating lease obligations -- -- -- -- -- Unconditional purchase obligations -- -- -- -- -- Employment agreements 2,336,250 446,250 630,000 630,000 630,000 ---------- ---------- ---------- ---------- ---------- Total $2,351,398 $ 448,566 $ 635,070 $ 637,762 $ 630,000 ========== ========== ========== ========== ========== In February 2005, we appointed our Chief Financial Officer, Mr. Joseph Frattaroli, as our President. Mr. Frattaroli will continue to serve as Chief Financial Officer and Acting Chief Executive Officer. The terms and provisions of this appointment are being finalized in writing and will be disclosed when the agreement is completed in a form approved by the Board of Directors. This table is presented reflecting the authorized annual salary to Mr. Frattaroli effective March 1, 2005 for one year. The written employment agreements with Mr. Masiz and Dr. Carter terminate their initial terms on June 30, 2008, but are deemed automatically extended for successive periods of two years under the terms of their respective written agreements through 2012. This table is presented assuming the automatic extensions are reflected. Mr. Masiz and Dr. Carter have agreed to waive, in writing, certain termination payout clauses contained in their respective employment agreements in the event that the Company becomes insolvent. Mr. Frattaroli has agreed in principle to a similar waiver, and will execute a similar waiver in writing when his employment agreement is finalized and executed. 30 OFF-BALANCE SHEET ARRANGEMENTS We have no material off-balance sheet financing such as a facility lease or other long-term commitments. We have employment agreements with three key employees. Please refer to "Contractual Obligations and Commitments" for a summary of the employment agreement obligations. OWNERSHIP STRUCTURE Through our parent company, Biochemics, John J. Masiz controls approximately 70% of the combined voting power of all classes of stock of the Company and approximately 44% of the combined equity interest of the Company. Biochemics owns 100% of the Class B Common Stock of the Company. RISK FACTORS WE ARE AN EARLY STAGE COMPANY WITH A BRIEF HISTORY OF LOSSES AND MAY NEVER ACHIEVE OR SUSTAIN PROFITABILITY. We do not have any continuing revenues and we have never been profitable and we may not achieve profitability in the foreseeable future, if at all. Our ability to generate profits in the future will depend on a number of factors, including: o start-up costs relating to the commercialization, sale and marketing of our products; o market acceptance of our products and product candidates; o costs of acquiring and developing new product candidates; o ability to bring our products to market; o general and administrative costs relating to our operations; o increases in our research and development costs; o charges related to purchases of technology or other assets; o ability to raise additional capital; and o the favorable resolution of our current litigation (see "Legal Proceedings"). At June 30, 2005, we had an accumulated deficit of approximately $8.5 million. We expect to incur additional operating losses as we expand our marketing, sales and development efforts. If we are unable to generate sufficient revenue from our operations to pay expenses or we are unable to obtain additional financing on commercially reasonable terms, our business, financial condition and results of operations may be materially and adversely affected. WE ARE AN EARLY STAGE COMPANY THAT HAS A LIMITED OPERATING HISTORY. We are an early stage company focused on commercializing, marketing and selling OTC pharmaceutical products. We began our operations as a division of BioChemics, Inc. in January 2001. We have only operated as an entity independent of BioChemics since January 2003. Our operating history is therefore limited. Our Termin8, A-R Extreme and Osteon products, which we license from BioChemics, are in the early stages of commercialization. Our product candidates are only in the early stages of development. With the exception of the introduction of deFEET to the marketplace by BioChemics while we were still a division of BioChemics, we have not yet recognized significant revenue from product sales. You should evaluate the likelihood of financial and operational success in light of the uncertainties and complexities present in an early-stage company, many of which are beyond our control, including: 31 o our potential inability to market, distribute, and sell our products; and o the significant investment of capital and other resources necessary to achieve our commercialization, marketing and sales objectives. Our operations have been limited to organizing and staffing our company, acquiring our license, developing and testing our revenue distribution models and test marketing our products. These operations provide a limited basis for you to assess our ability to commercialize our products and product candidates and the advisability of investing in us. THERE ARE SIGNIFICANT UNCERTAINTIES ABOUT OUR ABILITY TO CONTINUE AS A GOING CONCERN. Our recurring operating losses, liquidity issues and the uncertainties raised as a result of our legal proceedings raise substantial doubt about our ability to continue as a going concern. Our ability to continue as a going concern and the appropriateness of using the going concern basis of accounting depends upon, among other things on, the ability to generate sufficient cash from operations and financing sources to meet obligations. On August 16, 2005, we issued a series of Senior Secured Convertible Notes (the "Notes") due May 16, 2007 in the aggregate principal amount of $2,500,000. The company netted approximately $1,700,000 in cash proceeds, after taking into consideration placement fees, legal expenses, other offering costs, and escrow deposit, from this financing. Placement fees, legal expenses and other offering costs paid were approximately $360,000 and approximately $440,000 was placed into escrow, by agreement, for the benefit of the Company. The purpose of the escrow deposit is to fund substantially all of the Company's interest payments on the Notes. Under the terms of the Notes, the note holders may exercise an additional investment right (the "AIR") to purchase up to a total of an additional $1,875,000 in principal amount of Senior Secured Convertible Notes due May 1, 2007 under substantially the same terms and conditions as the Notes. Net of placement fees, legal expenses, other offering costs and escrow deposit, we expect to net approximately $1,300,000 if the AIR is exercised in full. We expect that the full $1,875,000 AIR will be exercised. If exercised in full, we anticipate, based on our current plans and assumptions relating to our operations, that the additional working capital provided by the exercise will be sufficient to satisfy our cash requirements through December 31, 2006. There can be no assurance that any of the AIR will be exercised. There can be no assurance that we will be able to obtain any additional financing or that, even if we do obtain additional financing, it will be on terms favorable to us. Further, there can be no assurance that we will be able to generate profitability and cash flows from operations with our existing working capital. We intend to continue as a going concern. However, unless we can generate profitability and cash flows from operations or obtain additional financing, we may not be able to continue as a going concern. There can be no assurance that we will be able to generate profitability and cash flows from operations with our existing working capital. Further, there can be no assurance that we will be able to obtain such additional financing or that, even if we do obtain additional financing, it will be on terms favorable to us. OUR FAILURE TO COMPLY WITH EXTENSIVE GOVERNMENT REGULATION MAY SIGNIFICANTLY AFFECT OUR OPERATING RESULTS. The worldwide marketing of our products and our product candidates are subject to extensive requirements by foreign, national, state and local governments. These regulations potentially impact many aspects of our operations, including testing, research and development, manufacturing, pre-market labeling, storage, quality control, adverse event reporting, record keeping, advertising and promotion. Failure to comply with applicable regulatory requirements could, among other things, result in: 32 o fines; o changes to advertising; o failure to obtain necessary marketing approvals; o revocation or suspension of regulatory approvals of products; o product seizures or recall; o delay, interruption or suspension of product manufacturing, distribution, marketing and sale; or o civil or criminal sanctions. The discovery of previously unknown problems with our initial and future products may result in the interruption of marketing, including withdrawal from the market. In addition, the FDA may revisit and change any prior determination relating to the safety or efficacy of our products. If circumstances change, we may be required to change our labeling or cease the marketing and manufacturing of the product or products at issue. Even prior to any formal regulatory action, we could voluntarily decide to cease the distribution and sale or recall any of our future products if concerns about their safety or efficacy develop. In their regulation of all our promotional materials, the FDA and the Federal Trade Commission, or FTC, may take issue with some advertising or promotional practices as being false, misleading or deceptive. The FDA or the FTC may impose a wide array of sanctions on companies for such advertising practices, which could result in any of the following: o incurring substantial expenses, including fines, penalties, legal fees and costs to comply with FDA or FTC requirements; o changing the methods of marketing and selling products; o taking mandated corrective action, which may include placing advertisements or sending letters to physicians and marketing partners rescinding previous advertisements or promotions; or o disrupting the distribution of products and causing the loss of sales until compliance with the FDA's or FTC's position is obtained. If we become subject to any of the above requirements, it could be damaging to our reputation, and our business condition could be adversely affected. WE CANNOT MARKET OUR PRODUCTS UNLESS THEY HAVE BEEN LISTED WITH THE FDA AND ARE COVERED BY THE FDA'S OTC REVIEW PROGRAM AND ARE MARKETED IN CONFORMITY WITH THE APPLICABLE OTC DRUG MONOGRAPH OR HAVE ATTAINED NDA OR ANDA APPROVAL. If our topical A-R Extreme, Osteon and Termin8 products are formulated and promoted in accordance with the OTC Drug Monographs pursuant to the FDA's OTC Review Program, FDA pre-market approval is not required prior to marketing. If these or any of our product candidates deviate from an OTC Drug Monograph requirement in active ingredients, intended use, method of administration, dosage form, or labeling, among other things, then we or our marketing partners must obtain New Drug Application, or NDA, pre-market approval from the FDA before beginning commercial marketing. The FDA has taken the position that insofar as our product candidates may use the VALE transdermal technology, they fall outside of those eligible for generally recognized as safe and effective, or GRASE, status under the OTC Review Program and thus we must obtain, or our marketing partners must obtain, NDA approval of these product candidates before they can be commercially marketed. Under the FDA's procedures, it is generally less burdensome to obtain NDA approval of a drug product which contains the same active ingredient(s) as those: (a) considered GRASE in a final OTC Drug Monograph, or (b) contained in a drug product eligible for abbreviated new drug application, or ANDA, approval, but which differs in certain conditions of use (e.g., dosage form) from that 33 covered by a final OTC Drug Monograph or eligible for ANDA approval. However, once a product becomes subject to the NDA requirements there can be no assurance that a company can generate the additional data and information necessary to support NDA approval of the proposed variant product or that approval can be obtained without substantial expenditures and delays. CLINICAL TRIALS MAY FAIL TO DEMONSTRATE THE SAFETY AND EFFICACY OF OUR PRODUCT CANDIDATES AND COULD PREVENT OR SIGNIFICANTLY DELAY REGULATORY APPROVAL. Prior to receiving NDA approval to commercialize any of our product candidates, we must demonstrate with substantial evidence from well-controlled clinical trials, and to the satisfaction of the FDA and other regulatory authorities in the United States and abroad, that the product candidate is both safe and effective. If these trials or future clinical trials are unsuccessful, our business and reputation would be harmed and our stock price would be adversely affected. All of our product candidates are prone to the risks of failure. The results of early-stage clinical trials of our product candidates will not necessarily predict the results of later-stage clinical trials. Product candidates in later-stage clinical trials may fail to show desired safety and efficacy traits despite having progressed through initial clinical testing. Even if we believe the data collected from clinical trials of our product candidates are promising, these data may not be sufficient to support approval by the FDA or any other U.S. or foreign regulatory approval. Preclinical and clinical data can be interpreted in different ways. Accordingly, FDA officials could interpret such data in different ways than we do which could delay, limit or prevent regulatory approval. The FDA, other regulatory authorities, or we may suspend or terminate clinical trials at any time. Any failure or significant delay in completing clinical trials for our product candidates, or in receiving regulatory approval for the sale of any products resulting from our product candidates, may severely harm our business and reputation. Because of these risks, the research and development efforts of our collaborative partners may not result in any commercially viable products. If a significant portion of these development efforts is not successfully completed, required regulatory approvals are not obtained by our partners, or any approved products are not commercially successful, we are not likely to generate significant revenues or become profitable. THERE IS NO ORGANIZED MARKET FOR OUR STOCK; OUR STOCK PRICE HAS BEEN VOLATILE AND COULD EXPERIENCE SUBSTANTIAL DECLINES. Our securities are currently quoted in the Pink Sheets under the trading symbol "VAPH.PK." The market price of our common stock has experienced, and may continue to experience, significant volatility. Since the beginning of 2004, the per share closing price of our common stock has ranged from $0.38 to $14.11. As a result of the temporary suspension of trading in our securities on April 1, 2004, our press release dated April 7, 2004 advising investors not to trade in our securities until further disclosure, and our voluntary delisting of our securities from The Nasdaq Stock Market on April 8, 2004, there is not currently an organized market in our securities, and there can be no assurance that such a market will develop. On August 19, 2005 the average bid for a share of our Class A Common Stock as quoted by the OTC Pink Sheets was $0.67 per share. The value of our Class A Common Stock may decline regardless of our operating performance or prospects. Factors affecting our market price include: o the success or failure of our product development efforts, especially those related to obtaining regulatory approvals; o technological innovations developed by us or our competitors; o variations in our operating results and the extent to which we achieve our key business targets; o differences between our reported results and those expected by investors and securities analysts; and o market reaction to any acquisitions or joint ventures announced by us or our competitors. 34 In addition, in recent years, the stock market in general, and the market for pharmaceutical companies in particular, have experienced significant price and volume fluctuations. This volatility has affected the market prices of securities issued by many companies, often for reasons unrelated to their operating performance, and it may adversely affect the price of our common stock. In the past, securities class action litigation has often been instituted following periods of volatility in the market price of a company's securities. A number of securities class action lawsuits have been filed against us. See "Legal Proceedings" for more information. WE ARE DEFENDANTS IN A NUMBER OF CLASS ACTION LAWSUITS THAT MAY ADVERSELY AFFECT OUR BUSINESS. As discussed in greater detail under "Legal Proceedings," we and certain of our officers were the defendants in a number of class action lawsuits filed on behalf of purchasers of Vaso Active's Class A common stock during the period December 11, 2003 to March 31, 2004, which allege that the defendants violated the federal securities laws by allegedly failing to make accurate and complete disclosures concerning Vaso Active, its business operations and future prospects, the clinical trial and endorsement of our Termin8 anti-fungal product (previously known as "deFEET") and the institutional demand for Vaso Active securities. The complaints sought equitable and monetary relief, an unspecified amount of damages, with interest, attorney's fees and costs. On June 1, 2005, Vaso Active entered into a MOU to settle the consolidated securities class action lawsuit. Under the terms of the MOU, the lead plaintiffs and the settling defendants agree that the final stipulation will contain a disclaimer of liability consistent with the MOU. Subject to the terms and conditions set forth in the MOU, settling defendants will pay into escrow for the benefit of the class $1,100,000 in cash and $750,000 face amount of 2-year 5% subordinated callable notes convertible at $1.75 per share within 10 business days of preliminary approval of the settlement by the court. In consideration of this payment, the parties will fully and finally release and discharge all claims against each other. The settlement still needs court approval. Vaso Active's insurance carrier has agreed to pay the $1,100,000 cash payment in exchange for a release of its liability under its insurance policy with us. BioChemics, our directors and certain of our officers are also parties to three shareholder derivative actions alleging a breach of the defendants' fiduciary duties to the Company. The complaints seek equitable and monetary relief, an unspecified amount of damages, and attorneys and other fees, costs and expenses, ostensibly on behalf of the Company. The June 1, 2005 MOU does not cover these derivative actions. While a settlement has been agreed to by the lead plaintiffs and the settling defendants in the consolidated securities class action lawsuit, the courts have not yet approved the settlement. In addition, we continue to defend ourselves against the three separate shareholder derivative actions. These securities lawsuits, and others which may be filed, could result in: o potential liabilities; o a material adverse financial statement impact o substantial costs for defending these suits; and o a diversion of management's attention and resources. If there are adverse developments in the lawsuits against us, or resolution of our regulatory matters with the SEC and the FDA takes longer than we expect, our capital resources could be adversely affected. Should these actions linger for a long period of time, whether ultimately resolved in our favor or not, or further lawsuits be filed against us, our financial results will be adversely affected by the need to pay the fees and costs incurred in defending these suits. Additionally, we may not be able to conclude or settle such litigation on terms that coincide with our ability to pay any judgment or settlement. The size of payments for damages and other costs related to these actions, individually or in the aggregate, could seriously impair our cash reserves and financial condition. In addition, the continued defense of this lawsuit also could result in continued diversion of our management's time and attention away from business operations, which could cause our financial results to decline. A failure to resolve definitively current or future material litigation in which we are involved or in which we may become involved in the future, regardless of the merits of the respective cases, could also cast doubt as to our prospects in the eyes of our customers, potential customers and investors, which could cause our revenues and stock price to further decline. 35 PROVISIONS IN OUR BYLAWS PROVIDE FOR INDEMNIFICATION OF OFFICERS AND DIRECTORS, WHICH COULD REQUIRE US TO DIRECT FUNDS AWAY FROM OUR BUSINESS OPERATIONS. Our bylaws provide for the indemnification of our officers and directors. We may be required to advance costs incurred by an officer or director and to pay judgments, fines and expenses incurred by an officer or director, including reasonable attorneys' fees, as a result of actions or proceedings in which our officers and directors are involved by reason of being or having been an officer or director of the Company. Funds paid in satisfaction of judgments, fines and expenses may be funds we need for the operation of our business, commercialization of our current products and the development of our product candidates, thereby affecting our ability to attain profitability. HISTORICALLY, WE HAVE DEPENDED ON A SMALL NUMBER OF CUSTOMERS FOR THE MAJORITY OF OUR NET REVENUE. As of the date of this report, we are not generating any significant revenues. We may not be able to generate significant revenues in the future. At various times, we and BioChemics have marketed Osteon, Athlete's Relief and deFEET on a "test basis" to experiment with consumer packaging and product performance receptivity, packaging size, label design along with other criteria. We consider this information important to deciding on an eventual roll out strategy for the products. We call these programs "test marketing" because neither Vaso Active nor its parent, BioChemics, was sufficiently capitalized to engage in advertising campaigns. In some cases, we terminated test marketing programs and in other cases, the retailer terminated test marketing programs. WE DEPEND ON BIOCHEMICS AND THIRD PARTIES TO DEVELOP AND MANUFACTURE OUR PRODUCTS AND PRODUCT CANDIDATES AND OUR COMMERCIALIZATION OF OUR PRODUCTS COULD BE STOPPED, DELAYED OR MADE LESS PROFITABLE IF BIOCHEMICS OR THOSE THIRD PARTIES FAIL TO PROVIDE US WITH SUFFICIENT QUANTITIES AT ACCEPTABLE PRICES. We do not possess product development capability. As a result, we depend on collaborations with third parties, such as BioChemics, for development of our product candidates. During the six months ended June 30, 2005 and 2004, we incurred research and development costs of approximately $177,500 and $142,500, respectively, related to the formulation of an analgesic utilizing the active ingredient ibuprofen as well as finalization of RepiDerm product development. These services were incurred pursuant to a February 2003 manufacturing and development agreement with BioChemics. In addition, we have no manufacturing capability. As a result, we will depend on BioChemics, which in turn will rely upon third parties to manufacture our products. Although our strategy is based on leveraging BioChemics' ability to develop and manufacture our products for commercialization in the OTC marketplace, we will be dependent on BioChemics' collaborations with drug development and manufacturing collaborators. If we and BioChemics are not able to maintain existing collaborative arrangements or establish new arrangements on commercially acceptable terms, we would be required to undertake product manufacturing and development activities at our own expense. This would increase our capital requirements or require us to limit the scope of our development activities. Moreover, we have limited or no experience in conducting full scale bioequivalence or other clinical studies, preparing and submitting regulatory applications, and manufacturing and marketing drug products. There can be no assurance that we will be successful in performing these activities and any failure to perform such activities could have a material adverse effect on our business, financial condition and results of our operations. If any of our developmental collaborators, especially BioChemics, breach or terminate their agreements with us or otherwise fail to conduct their collaborative activities in a timely manner, the preclinical and/or clinical development and/or commercialization of our product candidates will be delayed, and we would be required to devote additional resources to product development 36 and commercialization or terminate certain development programs. Also, these relationships generally may be terminated at the discretion of our collaborators, in some cases with only limited notice to us. The termination of collaborative arrangements could have a material adverse effect on our business, financial condition and results of operations. There also can be no assurance that disputes will not arise with respect to the ownership of rights to any technology developed with third parties. These and other possible disagreements with collaborators could lead to delays in the development or commercialization of our product candidates or could result in litigation or arbitration, which could be time consuming and expensive and could have a material adverse effect on our business, financial condition and results of operations. Additionally, the failure of any of our contract manufacturers to manufacture our products in conformity with current good manufacturing practices, or cGMPs, could result in interruption or halt of the availability of our products, pending demonstration to the FDA or a court of compliance with cGMPs. Any such interruption in the availability of our products could have a material adverse impact upon our financial position and results of operations. IF WE OR BIOCHEMICS FAIL TO ADEQUATELY PROTECT OR ENFORCE OUR INTELLECTUALPROPERTY RIGHTS, WE MAY BE UNABLE TO OPERATE EFFECTIVELY. BioChemics owns proprietary technology developed in connection with its four U.S. patents. In addition, foreign patents have been issued to BioChemics in 17 foreign countries and are pending in seven others. The PENtoCORE technology is not covered by patents but is considered proprietary. BioChemics also owns sixteen registered trademarks, including Osteon, RepiDerm, Termin8, and PENtoCORE. Our license agreement, as amended, with BioChemics permits us to commercialize market and sell our products and product candidates using these patents, proprietary formulations and the Osteon and PENtoCORE trademarks. Our success and ability to compete are substantially dependent on these patents, proprietary formulations and trademarks. Although both we and BioChemics believe that the patents and associated trademarks and licenses are valid, there can be no assurance that they will not be challenged and subsequently invalidated and/or canceled. The invalidation or cancellation of any one or all of the patents or trademarks would significantly damage our commercial prospects. Further, BioChemics may find it necessary to legally challenge parties infringing its patents or trademarks or licensed trademarks to enforce its rights thereto. There can be no assurance that any of the patents would ultimately be held valid or that efforts to defend any of the patents, trade secrets, know-how or other intellectual property rights would be successful. IF WE INFRINGE ON THE INTELLECTUAL PROPERTY RIGHTS OF OTHERS, OUR BUSINESS AND PROFITABILITY MAY BE ADVERSELY AFFECTED. Our commercial success will also depend, in part, on us and BioChemics not infringing on the patents or proprietary rights of others. There can be no assurance that the technologies and products used or developed by BioChemics and marketed and sold by Vaso Active will not infringe such rights. If such infringement occurs and neither we nor BioChemics is able to obtain a license from the relevant third party, we will not be able to continue the development, manufacture, use, or sale of any such infringing technology or product. There can be no assurance that necessary licenses to third-party technology will be available at all, or on commercially reasonable terms. In some cases, litigation or other proceedings may be necessary to defend against or assert claims ofinfringement or to determine the scope and validity of the proprietary rights of third parties. Any potential litigation could result in substantial costs to, and diversion of, our resources and could have a material and adverse impact on us. An adverse outcome in any such litigation or proceeding could subject us and/or BioChemics to significant liabilities, require us to cease using the subject technology or require us and/or BioChemics to license the subject technology from the third party, all of which could have a material adverse effect on our business. WE OPERATE IN A COMPETITIVE ENVIRONMENT AND THERE CAN BE NO ASSURANCES THAT COMPETING TECHNOLOGIES WOULD NOT HARM OUR BUSINESS DEVELOPMENT. 37 We are engaged in a rapidly evolving field. Competition from numerous pharmaceutical companies including Pfizer, Bristol-Myers Squibb, Schering-Plough, and biotechnology companies including, Alza, Cygnus and Elan, as well as research and academic institutions, is intense and expected to increase. Such companies have substantially larger research & development, marketing and promotion resources as well as histories of success in the marketplace. The market for transdermal and topical drug delivery systems is large and growing rapidly and is likely to attract new entrants. Numerous biotechnology and biopharmaceutical companies have focused on developing new drug delivery systems and most, if not all of these companies; have greater financial and other resources and development capabilities than we do. They also have greater collective experience in undertaking pre-clinical and the clinical testing of products; obtaining regulatory approvals; and manufacturing and marketing OTC and prescription pharmaceutical products. Accordingly, certain of our competitors may succeed in obtaining approval for products more rapidly than us. In addition to competing with universities and other research institutions in the development of products, technologies and processes, we may compete with other companies in acquiring rights to products or technologies from universities. There can be no assurance that our products, existing or to be developed, will be more effective or achieve greater market acceptance than competitive products, or that our competitors will not succeed in developing products and technologies that are more effective than those being developed by us or that would render our products and technologies less competitive or obsolete. TECHNOLOGICAL ADVANCEMENT BY OUR COMPETITORS COULD RESULT IN THE OBSOLESCENCE OF SOME OR ALL OF OUR PRODUCTS AND MAY HARM BUSINESS DEVELOPMENT. The areas in which we are commercializing, distributing, and/or selling products involve rapidly developing technology. There can be no assurance that we will be able to establish ourselves in such fields, or, if established, that we will be able to maintain our position. There can be no assurance that the development by others of new or improved products will not make our products and product candidates, if any, superfluous or our products and product candidates obsolete. SHOULD PRODUCT LIABILITY CLAIMS BE BROUGHT SUCCESSFULLY AGAINST US EXCEEDING THE PRODUCT LIABILITY COVERAGE WE CURRENTLY HAVE IN PLACE, THERE CAN BE NO ASSURANCES THAT SUCH EVENTS WOULD NOT MATERIALLY IMPACT OUR PERFORMANCE AND VIABILITY. The sale of our products may expose us to potential liability resulting from the sale and use of such products. Liability might result from claims made directly by consumers or by pharmaceutical companies or by others selling such items. We currently maintain $5 million of product liability insurance. There can be no assurance that we will be able to renew our current insurance, renew it at a rate comparable to what we now pay, or that the coverage will be adequate to protect us against liability. If we were held liable for a claim or claims exceeding the limits of our current or future insurance coverage, or if coverage was discontinued for any reason, it could have a materially adverse effect on our business and our financial condition. OUR LIMITED SALES AND MARKETING EXPERIENCE MAY ADVERSELY IMPACT OUR ABILITY TO SUCCESSFULLY COMMERCIALIZE AND SELL OUR PRODUCTS. We have limited sales and marketing experience, particularly with respect to marketing and selling products in commercial quantities. If we are unable to expand our sales and marketing capabilities we may not be able to effectively commercialize our products and product candidates. IF WE ARE UNABLE TO EFFECTIVELY PROMOTE OUR BRAND AND ESTABLISH A LEADING POSITION IN THE MARKETPLACE, OUR BUSINESS MAY FAIL. 38 Our brand names are new and unproven. If we are unable to effectively promote our brands and establish a prominent position in the marketplace, our operations will suffer. We believe that the importance of brand recognition will increase over time. In order to gain brand recognition, we may increase our marketing and advertising budgets to create and maintain brand loyalty. We do not know whether these efforts will lead to greater recognition. WE DEPEND ON BIOCHEMICS TO PROVIDE US WITH CERTAIN SUPPORT AND SERVICES. THE LOSS OF SUCH SUPPORT AND SERVICES WOULD HAVE A MATERIAL ADVERSE EFFECT ON OUR BUSINESS. We were originally formed as a division of BioChemics and the viability and financial strength of BioChemics is critical to our success. Throughout our development, we have relied on services and financing provided to us by BioChemics. When we became an independent operating entity, we entered into a license agreement and, prior to the consummation of our initial public offering, we entered into a manufacturing and development agreement, with BioChemics. We presently maintain our executive offices on premises that we share with BioChemics. We do not have a lease agreement with BioChemics. We believe that we can obtain suitable alternative space without any material disruption of our business and that such space will be available to us in the future on commercially reasonable terms. Since, pursuant to the administrative support agreement by and between the Company and BioChemics, BioChemics provides us with administrative and managerial support, our results of operations include allocations of certain BioChemics expenses, such as centralized accounting, data processing, utilities, supplies, telephone and other BioChemics corporate services and infrastructure costs. These expenses have been charged back to us as a management fee. We recorded approximately $23,000 and $16,320 in these related-party fees during the six-month periods ended June 30, 2005 and 2004, respectively. These costs are included in selling, general and administrative expenses. The expense allocations have been determined on the basis that we and BioChemics consider to be reasonable reflections of the utilization of services provided for the benefit received by us. The loss of the services provided by BioChemics or the loss of the license of the VALE patents or the PENtoCORE technology under the license agreement would have a material adverse effect on our business, financial condition and results of operations. BioChemics has never been profitable and most likely will not achieve profitability in the near future, if ever. Although BioChemics was founded in 1989, and incorporated in 1991, it is still a development stage company. It has generated significant losses through March 31, 2005, has limited revenue, and is likely to sustain operating losses in the foreseeable future. BioChemics' operations are subject to all of the risks inherent in the establishment of a business enterprise. Through December 31, 2004, BioChemics had an unaudited, consolidated accumulated deficit of approximately $17.7 million, which includes the operations of Vaso Active. In addition, as of December 31, 2004, BioChemics was in default under debt obligations in the approximate amount of $10.2 million, which includes accrued interest, that it has issued to private investors, of which approximately $6.9 million, inclusive of accrued interest, is held by Mr. Masiz, members of his family and the Chairman of the Board of Directors of the Company. Although BioChemics is attempting to restructure or refinance these obligations, there can be no assurance that it will be able to do so on acceptable terms. If BioChemics is not successful in maintaining its financial viability, our business, financial condition and results of operations may be materially and adversely affected. BioChemics anticipates that it will continue to incur net losses and be unprofitable for the foreseeable future. There can be no assurance that BioChemics will ever operate at a profit even if its or our products are commercialized. In addition, it is expected that BioChemics will encounter significant marketing difficulties and will also face significant regulatory hurdles. The likelihood of success of BioChemics must be considered in light of the problems, expenses, difficulties, complications and delays frequently encountered in connection with any non-profitable business enterprise, including but not limited to the identification and development of new products, difficulties with corporate partners, vendors, and a very competitive environment. Additionally, BioChemics itself requires additional capital and/or revenues to continue its operations and there is no guarantee that it will be able to fund its own operations or those of Vaso Active. 39 IF WE FAIL TO ATTRACT, TRAIN AND RETAIN ADDITIONAL HIGHLY QUALIFIED SENIOR EXECUTIVES AND TECHNICAL AND MANAGERIAL PERSONNEL IN THE NEAR FUTURE, OUR BUSINESS WILL SUFFER. Effective as of August 17, 2004 and in accordance with the terms of the SEC settlement, Mr. John J. Masiz resigned as President and Chief Executive Officer of Vaso Active. Vaso Active appointed its current Chief Financial Officer, Joseph Frattaroli, to serve as President and Acting Chief Executive Officer while it conducts a search for a new Chief Executive Officer. Due to a high demand for highly trained executives in our industry, there is no assurance that we will be able to attract or retain a suitable Chief Executive Officer now or in the future, and this could have a material adverse effect on our business, financial condition and results of operations. Effective June 18, 2004, Kevin J. Seifert resigned as the Chief Operating Officer and director of Vaso Active. Vaso Active is not currently conducting a search for a new Chief Operating Officer. Our former Chief Executive Officer has assumed Mr. Seifert's former responsibilities. Furthermore, several of our other key employees are devoting less than all their time to the Company. For example, although our Chief Scientific Officer, Dr. Stephen Carter devotes substantially all his time to our activities, he is only required to devote approximately 30% under his agreement with us. For us to pursue our product development, marketing and commercialization plans, we will need to hire personnel with experience in clinical testing, government regulation, manufacturing, marketing and finance. We may not be able to attract and retain personnel on acceptable terms given the intense competition for such personnel among high technology enterprises, including biotechnology, pharmaceutical and healthcare companies, universities and non-profit research institutions. If we lose any of these persons, or are unable to attract and retain qualified personnel, our business, financial condition and results of operations may be materially and adversely affected. MR. MASIZ IS MAJORITY STOCKHOLDER OF BIOCHEMICS, WHICH IS OUR PRINCIPAL STOCKHOLDER. HE HAS SUBSTANTIAL ULTIMATE CONTROL OVER THE COMPANY, POSSIBLY TO THE DETRIMENT OF OTHER HOLDERS OF OUR CLASS A COMMON STOCK. Our principal stockholder, BioChemics, owns 4,500,000 shares of our Class B common stock, which at June 30, 2005 represented approximately 70% of the combined voting power of our common stock. Mr. Masiz, as President, Chief Executive Officer and Chairman of BioChemics and, as the principal stockholder in BioChemics, will be able to control the outcome of many types of stockholder votes, including votes concerning the election of our directors, the adoption or amendment to provisions in our certificate of incorporation or by-laws, the approval of mergers and/or acquisitions, decisions affecting our capital structure and other significant corporate transactions. This concentration of ownership may delay, deter or prevent transactions that would result in a change of control, which in turn could reduce the value of our common stock. IN THE EVENT OF A CONFLICT OF INTEREST BETWEEN BIOCHEMICS AND VASO ACTIVE, OUR STOCKHOLDERS COULD BE NEGATIVELY AFFECTED. There are likely to be situations where our best interests and those of BioChemics will be in conflict. For example, we are a party to a license agreement, a manufacturing and development agreement and an administrative services agreement with BioChemics, each of which is critical to our business operations. To the extent that decisions are made by Mr. Masiz that could enhance the value of BioChemics versus the value to us, our stockholders interests could be negatively affected. 40 ITEM 3. CONTROLS AND PROCEDURES As of the end of the period covered by this quarterly report, our Acting Chief Executive Officer and Chief Financial Officer (the "Certifying Officer") conducted evaluations of our disclosure controls and procedures. As defined under Sections 13a-15(e) and 15d-15(e) of the 1934 Act, the term "disclosure controls and procedures" means controls and other procedures of an issuer that are designed to ensure that information required to be disclosed by the issuer in the reports that it files or submits under the 1934 Act is recorded, processed, summarized and reported, within the time periods specified in the SEC's rules and forms. Disclosure controls and procedures include, without limitation, controls and procedures designed to ensure that information required to be disclosed by an issuer in the reports that it files or submits under the Exchange Act is accumulated and communicated to the issuer's management, including the Certifying Officer, to allow timely decisions regarding required disclosure. Based on this evaluation, the Certifying Officer has concluded that our disclosure controls and procedures were effective to ensure that material information is recorded, processed, summarized and reported by our management on a timely basis in order to comply with our disclosure obligations under the 1934 Act, and the rules and regulations promulgated there under. Further, there were no changes in our internal control over financial reporting during the quarter that have materially affected, or are reasonably likely to materially affect, our internal control over financial reporting. 41 PART II - OTHER INFORMATION ITEM 1. LEGAL PROCEEDINGS SEC MATTERS On April 1, 2004, the SEC temporarily suspended trading of our securities. In its announcement of the trading suspension, the SEC stated that it temporarily suspended trading in our securities because of questions regarding the accuracy of our assertions, and others', in press releases, the 2003 annual report, our registration statement and public statements to investors concerning, among other things, the FDA approval of certain key products and the regulatory consequences of the future application of our primary product. In August 2004, the SEC formally approved the terms of a settlement regarding alleged violations of securities laws stemming from allegedly misleading disclosures in our initial public offering registration statement, our 2003 annual report and a statement on our website concerning the FDA's approval or qualification of our products. We agreed with the SEC to settlement terms without us admitting or denying the allegations of the civil complaint, pursuant to which the company is permanently enjoined from violating the anti-fraud provisions of the 1933 Act and the antifraud and reporting provisions of the 1934 Act. The SEC action filed with the United States District Court for the District of Columbia (the "Court") on August 17, 2004 is styled SECURITIES AND EXCHANGE COMMISSION V. VASO ACTIVE PHARMACEUTICALS, INC. Civil Action No. 04 CV 01395 (RJL) (D.D.C.). Also in August 2004, the SEC formally approved the terms of a settlement with John J. Masiz, our former President and Chief Executive Officer, without Mr. Masiz admitting or denying the allegations of the civil complaint, that likewise enjoins him from violating the antifraud and reporting provisions, and prevents him from serving as an officer or director of any public company, including Vaso Active, for a period of five years. Effective as of August 17, 2004, Mr. Masiz resigned as an executive officer and a director of Vaso Active. He is, however, permitted to remain an active employee and/or consultant of Vaso Active. In light of the foregoing, Vaso Active and Mr. Masiz agreed to terminate his employment agreement and enter into a new agreement. Pursuant to that agreement, Mr. Masiz will provide strategic consulting services regarding sales, marketing and business development to Vaso Active for an initial term through June 30, 2008 and will report to our Chief Executive Officer. We have appointed our Chief Financial Officer Joseph Frattaroli to serve as our Acting President and Acting Chief Executive Officer while we conduct a search for a new Chief Executive Officer. On September 13, 2004, the Court for the District of Columbia entered final judgments against Vaso Active and Mr. Masiz, pursuant to the above referenced settlement terms. PRIVATE LITIGATION In April, May, and June 2004, the Company and certain of its officers (the "Defendants") were sued in several securities class action lawsuits filed in the United States District Court for the District of Massachusetts. The complaints, which seek equitable and monetary relief, an unspecified amount of damages, with interest, attorneys' fees and costs, allegedly were filed on behalf of purchasers of Vaso Active Class A common stock during the period December 11, 2003 to March 31, 2004. The complaints allege that during the period in question the Defendants violated the federal securities laws by allegedly failing to make accurate and complete disclosures concerning the Company, its financial condition, its business operations and future prospects, the clinical trial and endorsement of the Company's Termin8 anti-fungal product (previously known as "deFEET") and the institutional demand for Vaso Active's securities. These complaints are captioned as follows: DENNIS E. SMITH V. VASO ACTIVE PHARMACEUTICALS, INC., ET AL. , Civ. No. 04-10708 (RCL) (D. Mass.);RICHARD SHAPIRO V. VASO ACTIVE PHARMACEUTICALS, INC., ET AL. , Civ. No. 04-10720 (RCL) (D. Mass.); CHRISTOPHER PEPIN V. VASO ACTIVE PHARMACEUTICALS, INC., ET AL. , Civ. No. 04-10763 (RCL) (D. Mass.); MODHI GUDE, ET AL. V. VASO ACTIVE PHARMACEUTICALS, INC., ET AL. , Civ. No. 04-10789 (RCL) (D. Mass.); KIM 42 BENEDETTO, ET AL. V. VASO ACTIVE PHARMACEUTICALS, INC., ET AL. , Civ. No. 04-10808 (RCL) (D. Mass.); DEAN DUMMER V. VASO ACTIVE PHARMACEUTICALS, INC., ET AL. , Civ. No. 04-10819 (RCL) (D. Mass.); EDWARD TOVREA V. VASO ACTIVE PHARMACEUTICALS, INC., ET AL. , Civ . No. 04-10851 (RCL); KOUROSH ALIPOR V. VASO ACTIVE PHARMACEUTICALS, INC., ET AL. , Civ. No. 04-10877 (RCL); PAUL E. BOSTROMV. VASO ACTIVE PHARMACEUTICALS, INC., ET AL. , Civ. No. 04-10948 (RCL); IRA A.TURRET SEP-IRA DATED 01/24/02 V. VASO ACTIVE PHARMACEUTICALS, INC., ET AL., Civ.No. 04-10980 (RCL); RICHARD PAGONA V. VASO ACTIVE PHARMACEUTICALS, INC., ET AL., Civ. No. 04-11100 (RCL); JAMES KARANFILIAN V. VASO ACTIVE PHARMACEUTICALS, INC.,ET AL. , Civ. No. 04-11101 (RCL); and CHARLES ROBINSON V. VASO ACTIVEPHARMACEUTICALS, INC., et. al., Civ. No. 04-11221 (RCL). The Court has consolidated the above-referenced cases, other than the TOVREA and KARANFILIA complaints in the United States District Court for the District of Massachusetts, under the caption IN RE VASO ACTIVE PHARMACEUTICALS SECURITIESLITIGATION , Civ. No. 04-10708 (RCL), (the "Consolidated Action"). On November4, 2004, the Court appointed Schiffrin & Barroway LLP as lead counsel for the Consolidated Action and appointed Shapiro, Haber & Urmy LLP as local counsel. The Court also appointed Edwin Choi, Richard Ching, and Joe H. Huback as interim co-lead plaintiffs, pending a determination of whether the Consolidated Action may proceed as a class action. The Court further ordered that co-lead plaintiffs file a consolidated amended complaint in the Consolidated Action no later than December 4, 2004. On December 3, 2004, plaintiffs filed the Consolidated Amended Complaint, which added as defendants the Company's directors at the time of our initial public offering and issuance of our 2003 Annual Report, and alleged that during the period in question the Defendants made false and misleading statements concerning FDA approval of its current products and related misstatements and concerning the clinical trial of the anti-fungal product. On January 20, 2005, the Defendants filed an Answer to the Complaint essentially denying the allegations and liability. On June 1, 2005, the Company entered into a Memorandum of Understanding Concerning Settlement Terms ("MOU") to settle the consolidated securities class action lawsuit. Under the terms of the MOU, the lead plaintiffs and the settling defendants agree that the final stipulation will contain a disclaimer of liability consistent with the MOU. Subject to the terms and conditions set forth in the MOU, settling defendants will pay into escrow for the benefit of the class $1,100,000 in cash and $750,000 face amount of 2-year 5% subordinated callable notes convertible at $1.75 per share within 10 business days of preliminary approval of the settlement by the court. In consideration of this payment, the parties will fully and finally release and discharge all claims against each other. The settlement still needs court approval. The Company's insurance carrier has agreed to pay the $1,100,000 cash payment in exchange for a release of its liability under its insurance policy with the Company. The Company has also been named as a nominal defendant in three shareholder derivative actions. The first action was filed in the United States District Court for the District of Massachusetts in April 2004 against the Company's directors and certain of its officers and against BioChemics, Inc. styled JOSEPH ROSENKRANTZ V. BIOCHEMICS, INC., ET AL., Civ. No. 04-10792 (RCL) (D. Mass.); the second - filed in June 2004, also against the Company's directors and certain of its officers and against BioChemics, Inc., styled WILLIAM POMEROY V. BIOCHEMICS INC., ET AL., Civ. No. 04-11399 (RCL) (D. Mass.); and the third - in the Court of Chancery for the State of Delaware in September 2004 against its directors and certain of its officers, entitled DOUGLAS WEYMOUTH V. JOHN J. MASIZ, ET AL., Civ. No. 682-N (collectively, the "Complaints"). The Complaints allege, among other things, that the alleged conduct challenged in the securities cases pending against the Company in Massachusetts (described above) constitutes, among other things, a breach of the Defendants' fiduciary duties to Vaso Active. The Complaints seek equitable and monetary relief, an unspecified amount of damages, and attorneys and other fees, costs and expenses, ostensibly on behalf of Vaso Active. On October 29, 2004, the Massachusetts Court approved a joint motion to consolidate the two Massachusetts derivative actions. On November 19, 2004, the Court issued an order consolidating the derivative actions in the United States District Court for the District of Massachusetts and captioned the consolidated action In Re: Vaso Active Pharmaceuticals, Inc. Derivative Litigation, Master Docket No. 04-10792-RCL. On January 12, 2005, the Court entered a Procedural Order of Dismissal which dismissed the consolidated derivative action, without prejudice, 43 pending the occurrence of the earlier of (a) the entry of an order in connection with a motion to dismiss filed in the securities class action lawsuit or (b) the filing of an answer by all defendants in the securities class action. This order also stated that the derivative litigation could be restored to the docket after either of the triggering events mentioned above occurred and a motion was filed by either party within 30 days after the occurrence of such an event. On February 3, 2005, plaintiffs in the consolidated derivative action filed an unopposed motion to restore the action to the docket, which was granted on February 23, 2005. On March 7, 2005, plaintiffs filed an amended complaint in this matter, and the defendants filed their answers on March 28, 2005. Although the Company has been defending and intends to continue to vigorously defend against these cases, there can be no guarantee as to the ultimate outcome of these matters. There is also no guarantee that these will be the only lawsuits brought against the Company with respect to these matters. There is also no assurance that these matters will be resolved in our favor. An unfavorable outcome of these matters would have a material adverse impact on our business, results of operations, financial position or liquidity. For the six-month periods ended June 30, 2005 and 2004, the Company recorded approximately $816,300 and $719,000 in expenses to defend itself in the SEC and private litigation matters discussed above, including legal, accounting and other consulting fees. The June 30, 2005 amount includes a $750,000 charge in connection with the Company's settlement with the consolidated securities class action lawsuit. FDA MATTERS We are not aware whether the FDA is contemplating any action against us. We believe that the active ingredients, dosage form and strengths of A-R Extreme, Osteon and Termin8 are covered by the FDA's OTC Review Program and therefore we believe these products are currently eligible for marketing under the same program. In early 2004, we intended to distribute these products under revised labeling once we were reasonably sure that the marketing of these products was consistent with the FDA's requirements and policies. We submitted new labels for our previously marketed products to the FDA in May 2004 and requested comments by the FDA on these labels. There is no regulatory requirement that the FDA review or comment on such materials and so far, the FDA has not provided any comment relating to the new labels. Although we were not provided any comment from the FDA, we are now reasonably sure that these new labels are consistent with all FDA regulations and policies and as a result, we resumed marketing and shipment of our products in September 2004. GENERAL Other than described above, we are not a party to any pending legal proceedings or are aware of any pending legal proceedings against us that, individually or in the aggregate, would have a material adverse affect on our business, results of operations or financial condition. 44 ITEM 6 (a). EXHIBITS EXHIBIT NUMBER DESCRIPTION OF EXHIBIT ------ ---------------------- 31.1 Certification of Joseph Frattaroli, Acting Chief Executive Officer and Chief Financial Officer, pursuant to Section 302 of the Sarbanes-Oxley Act of 2002.(1) 32.1 Certification of Joseph Frattaroli, Acting Chief Executive Officer and Chief Financial Officer, pursuant to Section 906 of the Sarbanes-Oxley Act of 2002.(1) (1) Filed herewith. ITEM 6 (b). REPORTS ON FORM 8K The Company issued a notification on Form 8K on June 2, 2005 that it had entered into a Memorandum of Understanding Concerning Settlement Terms to settle the consolidated securities class action lawsuit styled IN RE VASO ACTIVE PHARMACEUTICALS SECURITIES LITIGATION , Civ. No. 04-10708 (RCL). 45 SIGNATURE In accordance with Section 13 and 15(d) of the Exchange Act, the registrant caused this report to be signed on its behalf by the undersigned, thereunto duly authorized, on August 22, 2005 VASO ACTIVE PHARMACEUTICALS, INC. By: /s/ Joseph Frattarol -------------------------------------------- Joseph Frattaroli President and Acting Chief Executive Officer Chief Financial Officer 46