The Company had revenue of $954,000 and $-0- for the three months ended September 30, 2004 and 2003 respectively. The Company had revenue of $1,865,000 and $1,000,000 for the nine months ended September 30, 2004 and 2003 respectively. Revenue in 2004 was derived from the sale of research assays and fine chemicals at Oxis and a licensing agreement at Oxis for $450,000. In April 2003, Axonyx received a milestone payment of $1,000,000 from Serono International S.A. (Serono) under the terms of a license agreement for beta-sheet breaker technology that was signed in September 2000. The milestone payment was triggered when Serono initiated a Phase I clinical trial with a beta-sheet breaker peptide for the potential treatment of Alzheimer’s disease.
The Company’s costs of sales were entirely related to its majority owned subsidiary, OXIS. The percentage of cost of sales for both the quarter and nine months ended September 30, 2004 was 56%.
Research and development expenses were $6,054,000 and $986,000 for the quarters ended September 30, 2004 and 2003, respectively. Research and development expenses were $15,888,000 and $3,262,000 for the nine months ended September 30, 2004 and 2003, respectively. The increase is primarily attributable to the ongoing Phase IIB and Phase III pivotal trials underway in Europe. These trials commenced in June 2003. In June 2004, we have initiated a 2nd Phase III trial and incurred start up costs including the initial investigators meeting. Addditionally, preclinical studies in carcinogenicity and Absorption, Distribution, Metabolism and Excretion (ADME) increased by $2,292,000 from the same nine month period in 2003.
Sales, general and administrative expenses were $1,540,000 and $844,000 for the quarters ended September 30, 2004 and 2003, respectively. Sales, general and administrative expenses were $6,038,000 and $2,434,000 for the nine months ended September 30, 2004 and 2003, respectively. Non-cash charges relating to stock option grants to consultants were $1,484,000 compared to $544,000 in the nine months ended September 30, 2004 and 2003, respectively. Professional fees were $1,050,000 compared to $664,000 in the nine months ended September 30, 2004 and 2003, respectively. The increase in professional fees is primarily attributed to acquisition costs, utilization of outside council and patent filings. $2,122,000 of sales, general and administrative expenses relate to OXIS.
Interest income was $379,000 and $22,000 for the quarters ending September 30, 2004 and 2003, respectively. Interest income was $805,000 and $59,000 for the nine months ended September 30, 2004 and 2003. The increase reflects the higher cash and cash equivalent balances held in 2004 resulting from the cash collected from several private placements occurring in late 2003 and 2004.
Foreign exchange for the nine months ended September 30, 2004 was a loss of $40,000 compared to a foreign exchange gain of $13,000 for the nine months ended September 30, 2003. The loss reflects the increased transactions in Euro denominated currency and the valuation changes between the Euro and the U.S. dollar.
Gain on issuance of subsidiary stock was $71,000 for the nine months ended September 30, 2004. This gain results from common stock issued in OXIS.
Financing fees and interest expense reflect the cost of borrowing incurred by OXIS in obtaining temporary short term financing.
Net Loss
The Company experienced net losses of $6,693,000 ($0.13 per share-basic and diluted) and $1,803,000 ($0.07 per share-basic and diluted) for the quarters ended September 30, 2004 and 2003, respectively. The Company experienced net losses of $19,816,000 ($0.40 per share-basic and diluted) and $4,624,000 ($0.18 per share-basic and diluted) for the nine months ended September 30, 2004 and 2003, respectively. The increase in the net loss is primarily due to the expense of the ongoing Phase IIB and Phase III clinical trials for Phenserine, initiation of the 2nd Phase III clinical trial, an increase in the non-cash stock and option charges and our share of the net loss of OXIS.
Comprehensive Loss
The Company reported for the nine months ended September 30, 2004 a $32,000 foreign currency translation adjustment occurring in the OXIS subsidiary.
LIQUIDITY AND CAPITAL RESOURCES
As of September 30, 2004, we had $87,664,000 in cash and cash equivalents, and $82,465,000 in working capital. We do not have any available lines of credit. Since inception we have financed our operations from private placements of equity securities, the exercise of common stock purchase warrants, license fees, interest income and loans from a shareholder.
Net cash used in operating activities for the nine months ended September 30, 2004 was $15,394,000 resulting from a net loss of $19,816,000, offset in part by an increase in accounts payable and accrued expenses of $2,490,000, equity based compensation of $1,761,000 and depreciation and amortization expense of $1,061,000. Net cash used in operating activities for the nine months ended September 30, 2003 was $4,536,000 resulting from a net loss of $4,624,000, equity based compensation of $523,000 and a decrease in accounts payable and accrued expenses of $453,000.
Net cash provided from investing activities was $373,000 for the nine months ended September 30, 2004. $714,000 was acquired in connection with the Oxis acquisition offset in part by costs related to additions to patents, the acquisition of OXIS and office equipment purchases.
Net cash from financing activities for the nine months ended September 30, 2004 was $73,905,000. In January we received net proceeds of $46,394,000 from a private placement of $50,000,000 of securities through the sale of 9,650,183 shares of common stock and warrants. In May we received net proceeds of $18,364,000 from the private placement of $20,000,000 of securities through the sale of 3,076,923 shares of common stock and warrants. Additionally, we received $9,067,000 during the period from the exercise of stock options and warrants and $80,000 from the exercise of common stock options in OXIS.
Net cash from financing for the nine months ended September 30, 2003 was $31,529,000 of which $4,868,000 was from the collection of stock subscriptions receivable held in escrow from a private placement of shares of common stock and warrants that closed on December 31, 2002. Net cash from financing in June 2003 was $3,243,000. In June 2003, we received aggregate gross proceeds of approximately $2.3 million and issued 919,130 shares of common stock upon the exercise of warrants by fifteen holders of AXC warrants pursuant to a special offer. In June 2003, we raised aggregate gross proceeds of $575,000 through the sale of 230,000 shares of common stock at $2.50 per share in a private placement with four European accredited investors. Also in June 2003, we received gross proceeds of approximately $345,000 and issued approximately 775,000 shares to holders of AXD warrants who exercised their warrants. In September 2003, we received net proceeds of $23,418,000 from a private placement of common stock and warrants which closed on September 11, 2003.
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We currently have contracts with JSW Research of Austria, to undertake the ongoing Phenserine Phase IIb and Phase III clinical trials. We also have contracts with other CROs to provide services relating to Phenserine research and development activities including completing pre-clinical tests on the final drug formulation of Phenserine, undertaking carcinogenicity studies, bio-assays of blood plasma samples, and finalizing drug stability studies. We are currently finalizing a contract with a large CRO to conduct second and third pivotal cognition Phase III trials for Phenserine, each with a target enrollment of 450 patients. This multi-year contract is expected to be in the range of $20 million, depending upon the number of patients to be included in the trial. The studies commenced in 3rd quarter 2004 and are expected to run 24 to 30 months. Finally, under our Research Agreement we are funding a three year research program at the laboratory of Dr. David Small at Monash University in Australia concerning an assay method that is designed to screen potential drug compounds for Alzheimer’s disease that have an effect on beta-amyloid. This research project cost $75,000 in 2003, and it is anticipated to cost an additional $75,000 in the 2004 year. Under our Research and License Agreement with New York University, we must pay minimum annual royalty payments of $150,000 per year beginning in 2004 through the expiration or termination of that agreement. Our current real estate leases are all on a short-term basis.
We plan to finance our needs principally from the following:
• | our existing capital resources and interest earned on that capital; |
• | future private placement financing or other equity financings.. |
We believe that we have sufficient capital resources to finance our plan of operation for at least the next twenty-four months. However, as this is a forward-looking statement, and there may be changes that could consume available resources significantly before such time. Our long term capital requirements and the adequacy of our available funds will depend on many factors, including the eventual contract costs of undertaking the Phenserine Phase III clinical trials, regulatory delays, patent costs for filing, prosecuting, maintaining and defending our patent rights, among others.
We are regularly seeking potential equity financing, sub-licensing and other collaborative arrangements that may generate additional capital for us if the FDA requires us to enroll more patients or to conduct additional pivotal Phase III clinical trials. We cannot assure you that we will generate sufficient additional capital or revenues, if any, to fund our operations beyond the 24 month period ending September 30, 2006, that any future equity financings will be successful, or that other potential financings through bank borrowings, debt or equity offerings, or otherwise, will be available on acceptable terms or at all.
The Company’s liquidity and capital resources position is currently adequate to support its own development plans for at least the next 24 months. However, the liquidity and capital resource position of the Company’s majority owned subsidiary, OXIS, standing alone, is not adequate to support its ongoing operations without additional capital. OXIS’ working capital deficit increased during the first nine months of 2004 to $1,313,000, from a deficit of $36,000 at December 31, 2003.
OXIS expects to incur operating losses for the foreseeable future. There can be no assurance that OXIS will ever achieve profitable operations. The report of the OXIS’ independent auditors on the company’s financial statements for the period ended December 31, 2003, includes an explanatory paragraph referring to OXIS’ ability to continue as a going concern.
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OXIS needs to raise additional capital for continuing operations of the health products segment and to complete its contemplated drug development programs and no assurances can be given that OXIS will be able to raise such capital on favorable terms. As the majority stockholder and an “interested person” under Delaware law, the Company is limited in the ways in which it can provide financial assistance to OXIS. The unavailability of additional capital could cause OXIS to cease or curtail its operations and/or delay or prevent the development and marketing of the Company’s existing and potential products.
Executive Stock Trading Program
In June 2004, the Chairman of the Board and Chief Executive Officer of the Company, Marvin S. Hausman, M.D., adopted a pre-arranged stock trading plan in accordance with guidelines specified by Rule 10b5-1 under the Securities Exchange Act of 1934.
Rule 10b5-1 permits officers and directors of public companies to adopt pre-determined plans for selling specified amounts of stock. The plans may be entered into only when the director or officer is not in possession of material, non-public information and may be used to gradually diversify investment portfolios over a period of time.
Dr. Hausman will only sell shares of stock if the Company’s stock price exceeds $6.00 per share. As of November 2, 2004, Dr. Hausman has sold 80,000 shares, with a first trade on September 16, 2004. Under the terms of Dr. Hausman’s one-year plan, he may, prior to July 10, 2005, sell, on a pro rated monthly basis, up to an aggregate of 200,000 shares, which represents approximately 6.4% of the total number of shares and currently exercisable warrants and options he currently holds. Dr. Hausman has adopted his stock selling plan for financial planning purposes and to diversify his personal portfolio.
Critical Accounting Policies and Estimates.
This discussion and analysis of our financial condition and results of operations are based on our financial statements that have been prepared under accounting principles generally accepted in the United States of America. The preparation of financial statements in conformity with accounting principles generally accepted in the United States of America requires our 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 the financial statements and the reported amounts of revenue and expenses during the reporting period. Actual results could materially differ from those estimates. We have disclosed all significant accounting policies in note B to the financial statements included in our Form 10-K for the year ended December 31, 2003. Our critical accounting policies are:
Inventories: Inventories are stated at the lower of cost or market. Cost has been determined by using the first-in, first-out method.
Revenue recognition: We defer recognition of revenue from fees received in advance unless they represent the culmination of a separate earnings process. Such deferred fees are recognized as revenue over the term of the arrangement as they are earned, in accordance with the agreement. License fees represent the culmination of a separate earnings process if they are sold separately without obligating us to perform research and development activities or other services. Rights to license fees are recognized over the term of the arrangement. Nonrefundable, non-creditable license fees that represent the culmination of a separate earnings process are recognized upon execution of the license agreement. Revenue from the achievement of milestone events stipulated in the agreements will be recognized when the milestone is achieved. Royalties will be recognized as revenue when the amounts earned become fixed and determinable.
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Oxis manufactures, or has manufactured on a contract basis, products that are sold to customers. Oxis recognizes product sales upon sales of the product to the customers.
Oxis recognizes license fee revenue for licenses to intellectual property when earned under the terms of the agreements. Generally, revenue is recognized upon transfer of the license unless Oxis has continuing obligations for which fair value cannot be established, in which case the revenue is recognized over the period of the obligation. If there are extended payment terms, Oxis recognizes license fee revenue as these payments become due. All arrangements with payment terms extending beyond 12 months are not considered to be fixed or determinable. In certain licensing arrangements there is provision for a variable fee as well as a non-refundable minimum amount. In such arrangements, the amount of the non-refundable minimum guarantee is recognized upon transfer of the license unless we have continuing obligations for which fair value cannot be established and the amount of the variable fee in excess of the guaranteed minimum is recognized as revenue when it is fixed and determinable. Oxis recognizes royalty revenue based on reported sales by third party licensees of products containing its materials, software and intellectual property. If there are extended payment terms, royalty revenues are recognized as these payments become due. Non-refundable royalties, for which there are no further performance obligations, are recognized when due under the terms of the agreements.
Research, development costs: Research and development costs are expensed as incurred.
Risks and Uncertainties
The Company’s lead compound, Phenserine, is currently undergoing clinical testing in three Phase III trials and a Phase IIb clinical trial. Enrollment in the first Phase III trial was completed in June 2004 and the Company expects to have data from this trial, plus interim analysis data from the Phase IIb trial, available during the first quarter of 2005. Until the trial is unblinded and the results analyzed, there cannot be any assurance that the clinical endpoints in the protocol have been met.
Item 3. Quantitative and Qualitative Disclosures About Market Risk.
We have foreign currency accounts that are exposed to currency exchange risk. These foreign currency accounts have been utilized to fund the operations of our wholly owned subsidiary, Axonyx Europe, based in the Netherlands. We had a net foreign exchange loss of $40,000 for the nine months ended September 30, 2004 and a gain of $13,000 for the nine months ended September 30, 2003. If the foreign currency rates were to fluctuate by 10% from rates at September 30, 2004 and 2003, the effect on our financial statements would not be material. However, there can be no assurance there will not be a material impact in the future. During 2003, we adopted a policy to limit the purchase of foreign currencies to the amounts necessary to cover firm contractual commitments in foreign currencies for the forward six months. However, as long as we continue to fund our foreign operations, we will be exposed to some currency exchange risks. The majority of our ongoing clinical trials are being conducted in Europe.
We consider our investments in money market accounts, short term commercial paper and time deposits as cash and cash equivalents. The carrying values of these investments approximate fair value because of the short maturities (three months or less) of these instruments and accounts. Therefore, changes in the market’s interest rates do not affect the value of the investments as recorded by us.
We do not enter into or trade derivatives or other financial instruments or conduct any hedging activities.
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Item 4. Controls and Procedures. |
Evaluation of Disclosure Controls and Procedures
Our management, with the participation of our principal executive officer and principal financial officer, has evaluated the effectiveness of the design and operation of our disclosure controls and procedures (as defined in Rules 13a-14(c) and 15d-14(c) under the Securities Exchange Act of 1934, as amended) as of the end of the period covered by this quarterly report on Form 10-Q. Based on this evaluation, our principal executive officer and principal financial officer concluded that these disclosure controls and procedures are effective and designed to ensure that the information required to be disclosed in our reports filed or submitted under the Securities Exchange Act of 1934 is recorded, processed, summarized and reported within the requisite time periods.
Our management, including our Chief Executive Officer and Chief Financial Officer, does not expect that our disclosure controls and procedures or internal control over financial reporting will prevent all errors and all fraud. A control system, no matter how well conceived and operated, can provide only reasonable, not absolute, assurance that the objectives of the system are met and cannot detect all deviations. Because of the inherent limitations in all control systems, no evaluation of controls can provide absolute assurance that all control issues and instances of fraud or deviations, if any within the company have been detected. While we believe that our disclosure controls and procedures have been effective, in light of the foregoing, we intend to continue to examine and refine our disclosure control and procedures to monitor ongoing developments in this area.
Changes in Internal Controls
There was no change in our internal control over financial reporting (as defined in Rules 13a-15(f) and 15d-15(f) under the Securities Exchange Act of 1934, as amended) identified in connection with the evaluation of our internal control performed during our last fiscal quarter that has materially affected, or is reasonably likely to materially affect, our internal control over financial reporting.
| 31.1 | Certification of Chief Executive Officer pursuant to Exchange Act Rules 13a-14(a) and 15(d)-14(a), adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| 31.2 | Certification of Chief Financial Officer pursuant to Exchange Act Rules 13a-14(a) and 15(d)-14(a), adopted pursuant to Section 302 of the Sarbanes-Oxley Act of 2002. |
| 32.1 | Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
| 32.2 | Certification of Chief Financial Officer pursuant to 18 U.S.C. Section 1350, adopted pursuant to Section 906 of the Sarbanes-Oxley Act of 2002. |
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SIGNATURES
Pursuant to the requirements of the Securities Exchange Act of 1934, the Registrant has duly caused this report to be signed on its behalf by the undersigned thereunto duly authorized.
Dated November 10, 2004.
| | AXONYX INC.
By: /s/ Marvin S. Hausman, M.D. —————————————— Marvin S. Hausman, M.D. Chairman and Chief Executive Officer |
| |
By: /s/ S. Colin Neill —————————————— S. Colin Neill Chief Financial Officer, Secretary and Treasurer (Principal Financial and Accounting Officer) |
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