Form 10QSB for IN VERITAS MEDICAL DIAGNOSTICS, INC.
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14-Jun-2007
Quarterly Report
ITEM 2. MANAGEMENT'S DISCUSSION AND ANALYSIS AND PLAN OF OPERATION
Forward-Looking StatementsThe information in this quarterly report contains forward-looking statements within the meaning of the Private Securities litigation Reform Act of 1995. This Act provides a "safe harbor" for forward-looking statements to encourage companies to provide prospective information about their business and operations so long as they identify these statements as forward looking and provide meaningful cautionary statements identifying important factors that could cause actual results to differ from the projected results. All statements other than these statements of historical fact made in this report are forward looking. In particular, the statements herein regarding industry prospects and future results of operations or financial position are forward looking statements. Forward-looking statements reflect management's current expectations and are inherently uncertain. Our actual results may differ significantly from management's expectations.
The following discussion and analysis should be read in conjunction with the financial statements of In Veritas Medical Diagnostics, Inc., included herewith. This discussion should not be construed to imply that the results discussed herein will necessarily continue into the future, or that any conclusion reached herein will necessarily be indicative of actual operating results in the future. Such discussion represents only the best present assessment of our management.
Plan of Operation
Overview
In Veritas Medical Diagnostics Inc. ("IVMD" or the "Company") specializes in the field of near patient medical diagnostics, also known as "point of care". We develop products to address conditions affecting large numbers of the population which are aimed at transforming their lives, quality of treatment and significantly reducing healthcare costs. We focus on developing products which are designed to be accurate, cost effective, easy to use, and portable. Our products are designed to bring diagnosis into patients' hands.
We operate through two wholly owned subsidiaries located in England and Scotland, both of which are incorporated under the Laws of England and Wales:
(A) IVMD (UK) Limited, and (B) Jopejo Limited.
Our website is located at www.ivmd.com.
Intellectual Property and Product Development
We have applied for thirteen patents, three of which have been granted. We are currently working on a number of additional patent applications in related areas. Patent protection and management is an important part of our business model.
The first product to be completed using our technology is a prothrombin measurement device, which is used for the measurement of coagulation of blood in patients at risk of heart disease and stroke.
The prothrombin measurement device (the "PT Device") was developed under a research and development contract with Inverness Medical Innovations Inc ("IMI"), which was entered in on November 11, 2002 (the "IMI Agreement"). Pursuant to the IMI Agreement, we are entitled to two types of revenue streams:
(i) billings to IMI for our development work during the product development phase and (ii) royalties equal to 2% of net revenues from the sale of the PT Device. The product development phase of the IMI Agreement has been completed. Commercialization of the PT Device by IMI is expected to commence in 2008. IMI will oversee sales and marketing of the prothrombin device and we will not have any influence over this process.
We are developing additional hand held or portable products which are focused on
(a) the measurement and detection of pregnancy and labor and (b) the detection of diseases and medical conditions using magnetic detection techniques applied to tissue and blood. We routinely seek to identify potential product applications which would benefit from our technology and know-how and we are in discussions with several parties which our management believes may result in commercial, revenue earning contracts.
Results of Operations
Three and Nine months ended April 30, 2007 compared to Three and Nine months ended April 30, 2006
Revenues
We did not generate any revenues during the three and nine months ended April 30, 2007, as compared to revenues of $311,109 and $1,077,451766, the three and nine months ended April 30, 2006. The decline in revenues is due to the completion of the produce development phase of our agreement with IMI. As explained above, the next phase of the IMI agreement involves our receiving royalties from future sales of the PT Device by IMI. Additionally, we are seeking to enter into additional research and development or IPR license contracts.
Depreciation Expenses
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Depreciation expenses for the three and nine months ended April 30, 2007 amounted to $1,751and $8,318, respectively compared to $8,009 and $24,075 for the three and nine months ended April 30, 2006, respectively. The decline is due to that fact that it has not been necessary to replace or update any of our fixed asset base which is adequate for our purposes and therefore the depreciation charge continues to decline.
General & Administrative Expenses
General and administrative expenses for the three and nine months ended April 30, 2007 were $91,457 and $367,240, respectively, as compared to $136,009 and $413,729 for the three and nine months ended April 30, 2006, respectively. This change reflects efforts to reduce general and administrative expenses. Because of our cash shortages we have deferred payment of as many general and administrative costs as possible.
Sales and Marketing Expenses
We incurred $75,964 of marketing costs in the three month period ended April 30, 2007, and $218,425 in the nine period ended April 30, 2007, as compared to $Nil for the three and nine month period ended January31, 2006. With the conclusion of the IMI contract we have the capacity to explore new commercial contracts to exploit our various technologies and these new costs include general commercial and promotional activity, attendance at trade fairs and exhibitions and compensation for our business development manager and associated costs. Several important commercial opportunities have been developed from this new activity all of which are currently being followed through. To conserve cash our main marketing contractors have accepted shares of our common stock as consideration for services performed.
Research & Development Expenditure
During the three months ended April 30, 2007, we spent $128,444 on research and development compared to $314,746 during the three month period ended April 30, 2006.. We spent $459,050 in the nine month period ended April 30, 2007 compared to $901,416 for the nine month period ended April 30, 2006 on research and development. In the three month period ended April 30, 2007 our R&D activity was focused on preparing our new (post PT Device) technology for potential future product launches. This activity focused on our Magnetic Strip Reader technology and our Magnetic Detection technology. By comparison, during the three month period ended April 30, 2006, our R&D expenditure was focused on the PT Device and was substantially higher because of the volume of outsourced R&D expenditure required to develop the PT Device.
Stock Option Expense
No stock options were awarded during the nine month period ended April 30, 2006. By comparison we granted stock options to purchase 16,015,000 shares of our common stock to members of our management team pursuant to our 2005 Incentive Stock Plan during the three month period ended October 31, 2006. We account for stock option expense under the provisions of SFAS No. 123(R) whereby we value stock options using the Black Scholes method and spread the charge equally from the date of grant until the date that the options vest, adjusting for options that we believe are unlikely to ever vest. 2,500,000 of the options granted during the three month period ended October 31, 2006 vested on the grant date, resulting in an abnormal charge of $162,000. The remaining options vest over various periods through September 30, 2010. The total charge for option expense in the three month period ended April 30, 2007 amounted to $135,315 and $539,770 during the nine month period ended April 30, 2007 compared to $0 and $0 in the three month and nine month periods ended April 30, 2006, respectively.
Net Income (Loss)
Net loss before other income and expense (which included interest expense) for the three months ended April 30, 2007 was $(443,130), as compared to a net loss of $(154,736) for the three months ended April 30, 2006. During the nine month period ended April 30, 2007 the net loss before other income and expense (which included interest expense) was $(1,803,889) compared to $(552,694) in the nine month period ended April 30, 2006. The increase in net loss is attributable to
(a) the completion of the product development phase of the IMI Agreement, and
(b) the grant of a significant number of stock options to members of our management team.
Net loss (after other income and expense, including interest) for the three and nine month period ended April 30, 2007 amounted to $(696,546) and $(2,515,986), respectively compared to $(306,062) and $(892,288) for the three and nine month period ended April 30, 2006, respectively. The increase in net loss was due to the factors discussed above, as well as interest expense amounting to $253,416 and $712,097 in the three and nine month period ended April 30, 2007, respectively as compared to $96,429 and $233,177 in the three and nine month period ended April 30, 2006, respectively. The increase in interest expense is attributable to punitive interest charges related to outstanding debt obligations of the Company which were in default during the three month period ended October 31, 2006 and the generally increased debt burden of the Company.
Liquidity and Capital Resources
We have incurred operating losses since our inception. At April 30, 2007, we had an accumulated deficit from inception of $(11,271,357). We are in default under the terms of certain of our credit obligations and are operating at the forbearance of our creditors. Our auditors, in their report on our financial statement for the fiscal year ended July 31, 2006, have expressed substantial doubt about our ability to continue as a going concern.
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The Company's working capital needs include payment of salaries, administrative expenses, and research and development activities. At April 30, 2007, we had a cash balance of $1,459 and current liabilities of $5,555,061. The Company's cash balances at April 30, 2007 are not sufficient to support operations for the next twelve months and it is necessary for the Company to continue to seek one or more of the following: (i) additional financing in the form of equity and/or debt, (ii) additional grants from the U.K. government; and (iii) product development contracts with commercial partners. As explained in Note 9 to the Unaudited Condensed Consolidated Financial Statements (set forth in Part I herein) and further explained in the section below entitled "Recent Financings", the Company has been active, and continues to be active, in seeking to secure new sources of financing. However, there can be no assurance that that any additional financing will become available on terms that are acceptable to us and, as further explained in Note 9 to the Unaudited Condensed Consolidated Financial Statements (set forth in Part I herein) and further explained in the section below entitled "Recent Financings" since April 30, 2007; Westek, who had been funding the Company by way of short term advances, notified the Company and the other loan note holders (referred to in Note 9) that it was not prepared to continue to do so in future unless agreement is reached with those loan note holders regarding the shared ongoing responsibility for funding the Company and other related matters. Negotiations between Westek and the other loan note holders are ongoing and the future viability of the Company and its underlying business is dependent upon the outcome of these discussions. There can be no assurance that an arrangement can be worked out among the parties. If an agreement is not reached among the parties, we may be forced to curtail our operations.
Critical Accounting Policies
Principles of consolidation
Our consolidated financial statements include our accounts and the accounts of our two wholly owned foreign subsidiaries; IVMD (UK) Limited and Jopejo Limited, both UK companies. The assets and liabilities of our foreign subsidiaries have been translated from British pounds into U.S. dollars at the exchange rate in effect at April 30, 2007 with the related translation adjustments reported as a separate component of shareholders' deficit. Operating statement accounts have been translated at the average exchange rate in effect during the period presented. All significant intercompany transactions have been eliminated.
Basis of presentation
Our research and development is conducted in Inverness, Scotland, through our subsidiaries: IVMD (UK) Limited and Jopejo Limited. Development-stage activities consist of raising capital, obtaining financing, medical products research and development and administrative matters.
We are a development stage enterprise and have incurred losses since inception. We had a net capital deficit at April 30, 2007 of $(5,984,337). We also had substantial net current liabilities at April 30, 2007 and we were in default on several of our Notes Payable, as explained in Item 3 of Part 2. These factors, among others, raise substantial doubt about our ability to continue as a going concern, in common with many development stage companies in our industry. Historically we have depended on various sources of finance to support ongoing operations, in particular, until our various products and work in progress reach the point where they generate income (which cannot be assured) we are dependent upon external funding, which has generally been made available to us in the past by way of convertible loan notes provided by specialist investment funds. Since November 2006 such funding has not been forthcoming and we have depended upon short term advances from two of our loan note holders, as explained in Note 9 to the Unaudited Condensed Consolidated Financial Statements (set forth in Part I herein). More recently those advances have been restricted to one loan note holder, a related party, Westek. As explained in Note 9 to the Unaudited Condensed Consolidated Financial Statements, Westek has recently notified the Company and the other loan note holders (referred to in Note 9) that it was not prepared to continue to do so in future unless agreement is reached with those loan note holders regarding the shared ongoing responsibility for funding the Company and other related matters Negotiations between Westek and the other loan note holders are ongoing and the future viability of the Company and its underlying business is clearly dependent upon the outcome of these discussions. The outcome of those negotiations can not be predicted at this time. There can be no assurance that an arrangement can be worked out among the parties. If an agreement is not reached among the parties, we may be forced to curtail our operations.
Use of Estimates
The preparation of financial statements in accordance with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and the disclosure of contingent assets and liabilities at the date of financial statements and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates.
Research & Development Expenditure
Research & Development expenditure is written off as it is incurred.
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Revenue Recognition
We recognize revenue in accordance with SEC Staff Accounting Bulletin No. 104 "Revenue Recognition in Financial Statements" (SAB 104). Arrangements with multiple elements are accounted for in accordance with Emerging Issues Task Force Issue No. 00-21, Revenue Arrangements with Multiple Deliverables, or EITF 00-21. We consider this methodology to be the most appropriate for our business model and current revenue streams.
Currently our only revenue streams relate to research and development contracts under which we enter into collaborative agreements with medical technology companies where the other party generally receives exclusive marketing and distribution rights for certain products for set time periods and set geographic areas. The terms of the collaborative agreements typically include funding of certain research and development efforts and royalties on product sales.
Revenue from research funding is recognized when the services are performed and is typically based on the fully burdened cost of a researcher working on a collaboration plus reimbursement of other costs incurred
Currently we receive revenue mainly from contracts which we enter into with commercial partners who work with us to develop new products which employ our core technology. This revenue is generally in the form of contribution towards development costs that we incur and is accounted for in accordance with the underlying contracts. In the future we anticipate the nature of our principle revenues changing from contribution towards development expenditure to royalty income from developed products, this change will not take place until products that are currently in development have been completed and are taken to market. Whilst there can be no assurance we currently expect our first royalty income to commence in the last quarter of 2006.
Recent Financings and Restructurings
Termination, Settlement, and Forbearance Agreement (Cornell / Montgomery Debenture)
On October 19, 2006, the Company entered into a Termination, Settlement, and Forbearance Agreement effective as of October 16 (the "Settlement Agreement"), with Cornell Capital Partners LP ("Cornell") and Montgomery Equity Partners Ltd. ("Montgomery"), an affiliated fund of Cornell. The Settlement Agreement relates to a Standby Equity Distribution Agreement (the "Distribution Agreement") with Cornell and a Securities Purchase Agreement (the "Purchase Agreement") with Montgomery entered into on September 7, 2005.
The Distribution Agreement with Cornell provided for the sale and issuance to Cornell of up to $10,000,000 of Common Stock over a period of up to 24 months after the signing of the Distribution Agreement. In addition as part of the commitment fee arrangements the Company issued 472,000 shares of the Company's common stock to Cornell.
The Purchase Agreement with Montgomery provided for the sale by the Company to Montgomery of its 18% secured convertible debentures in the aggregate principal amount of $750,000 of which $300,000 was funded. Under the Purchase Agreement, the Company also issued to Montgomery three-year warrants to purchase 350,000 shares of Common Stock at $0.001 per share. As further security for its obligations under the Purchase Agreement and the Accredited Investor Purchase Agreement, the Company deposited into escrow 25,685,000 shares (the "Escrow Shares") of common stock. The Escrow Shares are deemed issued but not outstanding.
Subsequent to the completion of the Standby Equity Distribution Agreement and the sale of the 18% secured convertible debentures pursuant to the Securities Purchase Agreement in September 2005, the Company prepared and filed a registration statement on Form SB-2 (File No. 333-128321) with the Securities and Exchange Commission for the purpose of registering the securities underlying such financing transactions. In connection therewith, the Company received comments from the Commission indicating that, in the Commission's view, based upon the structure of the transactions, the Company may not register the securities sold in the financing transactions. On March 6, 2006, the Company withdrew the registration statement on Form SB-2 (File No. 333-128321) by filing a Form R-W with the Commission. As a result, the Company has not been able to draw down any further amounts under the Debenture. In addition, because of the failure to complete the entire financing transaction contemplated in the September 2005 financing, the Company has been unable to pay interest and principal payments on the Debentures.
Pursuant to the Settlement Agreement, the parties agreed to the following principal terms:
· The Company shall pay Montgomery an aggregate of $348,000.00 (the "Funds") which represents all amounts owed by the Company to Montgomery under the Debenture as of the date hereof including outstanding principal and interest. The Company shall pay the Funds to Montgomery monthly at the rate of $29,000.00 ("Monthly Payment") per calendar month, with the first payment being due and payable on November 15, 2006 and each subsequent payment being due and payable on the first business day of each subsequent month until the Funds are repaid in full.
· Montgomery shall continue to have valid, enforceable and perfected first-priority liens upon and security interests in the Pledged Property and the Pledged Shares (each as defined in the Purchase Agreement transaction documents) and in the Financial Statements set out in Part 1 above.
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· The Company and Montgomery agree that during the term of the Settlement Agreement, the Debenture shall not bear any interest and no liquidated damages shall accrue under any of the financing documents.
· The Conversion Price (as set forth in the Debenture) in effect on any Conversion Date (as set forth in the Debenture) from and after the date hereof shall be adjusted to equal $0.05, which may be subsequently adjusted pursuant to the other terms of the Debenture.
· Montgomery shall retain the Warrants issued in accordance with the Securities Purchase Agreement.
· The Company and Cornell agree to terminate the Distribution Agreement and related transaction documents and related penalties and redemption premium payments lapse provided that the Company complies with the terms of the amended terms described above.
· Cornell shall retain the 472,000 shares of the Company's common stock.
Westek Loan Amendment
On November 21, 2006, we entered into an amendment to the Loan Agreement with Westek dated as of June, 2004. Pursuant to the amendment, the maturity date of the Loan has been extended to March 31, 2008, and interest will accrue at the rate of 10% beginning in October 2007. The Loan has an outstanding principal balance of $1,800,000.
Graham Cooper, the Company's Chairman, President and Chief Executive Officer, is the principal stockholder of Westek Limited.
Triumph Loan Restructuring
On November 29, 2006, the Company issued two secured subordinated convertible notes to Triumph Small Cap Fund, Inc. ("Triumph") in an aggregate principal amount of $440,000. The first note, in a principal amount of $275,000, was issued in consideration of cash advances made to the Company by Triumph during the three month period ended October 31, 2006. The second note, in a principal amount of $165,000, was issued in exchange for a secured convertible note previously issued to a designee of Triumph. The notes bear interest at the rate of 8% per annum and mature on April 30, 2008. The notes are convertible, at Triumph's option, into shares of the Company's common stock at a conversion price of $0.05 per share, subject to a 9.99% conversion restriction.
Subsequently, on December 8, 2006, the Company and Triumph entered into an addendum pursuant to which the principal amount of the first note was increased from $275,000 to $335,000.
Longview Loan Restructuring
On January 9, 2007, the Company issued two secured convertible notes to Longview Fund L.P. ("Longview") (one of the investors in the Accredited Investor Purchase Agreement referred to above) in the aggregate principal amount of $309,300.
· The first, for $261,300, was issued in exchange for the interest and principal outstanding under the Debenture previously issued to Longview under the terms of the Accredited Investor Purchase Agreement. The note (a) matures on April 30, 2008; (b) bears interest at the rate of 18% per annum, which is payable in accordance with the repayment provisions described in the Note and (c) is convertible at Longview's option, into shares of the Company's common stock at a conversion price of $0.05 per share. Minimum repayments are due under the note as follows: (i) two installments of $12,500 each were due to be paid on or before February 28, 2007 and March 30, 2007; (ii) monthly installments of $15,000 commencing on November 30, 2007; and (iii) the balance due of principal plus unpaid interest on maturity.
· The second, for $48,000 was issued in exchange for liquidated damages payable as a result of the default on the Debenture previously issued to Longview under the terms of the Accredited Investor Purchase Agreement. This note has the same interest and a conversion term as the first amount, described above, but is repayable on maturity (principal and interest).
Subsequent to the restructuring of the Loan Notes with Longview and Cornell / Montgomery, both described above, the Company has been unable to comply with the payment installments due under the terms of the restructured loan notes. Also described above; and the Company is therefore in default under these new Loan Notes.
Royalty Participation Agreement
On May 5, 2006, we completed the sale of a percentage of future royalties pursuant to a Royalty Participation Agreement (the "Agreement") with The Rubin Family Irrevocable Stock Trust. The royalties to be paid pursuant to the Agreement are derived from the Patent License Agreement with Inverness Medical Innovations, Inc. (the "IMI Agreement") pursuant to which the Company will receive royalties from the sale of a Prothrombin blood clotting measuring device (the "IMI Royalties). The IMI Agreement is further described in the "Organization and Basis of Presentation" section of these financial statements. On November 29, 2006 the Company entered into a similar agreement with Triumph Small Cap Fund, Inc. in consideration of cash advances made to the Company by Triumph during June and July 2006.
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Pursuant to the two royalty participation agreements, the Company received aggregate proceeds of $450,000 in exchange for 10% of the future IMI Royalties received by the Company, subject to the terms and conditions set forth in the two agreements. Pursuant to the two agreements, the IMI Royalties shall be paid to The Rubin Family Irrevocable Stock Trust and Triumph ("The Investors") within 15 days of the end of the month in which the Company receives future IMI Royalties. The Company has the option to terminate the Agreement at any time, without penalty, by making a lump sum payment to the Investors equal to 300% of the funds received from the Investors pursuant to the Agreement, or $1,350,000. If no royalties are paid to the Investors by December 31, 2007, or if $450,000 of royalties is not made by December 31, 2008, the Investors shall have the right to convert the advances made into a three year note with a face value of $1,350,000 accruing interest at 4% above prime and repayable at maturity.
Short Term Advances since November 2006
As explained above, we have depended on various sources of finance to support ongoing operations, in particular, until our various products and work in progress reach the point where they generate income (which cannot be assured) we .
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