-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, JSY1n6ECw4qZTjiRhigNVpUQKRLx8gWUNvLF9NN2ad5Bg9EiqTyIEstoUYqQi0Rx KdgR4a1nAF2Ho2djlDGj5g== 0000909012-06-000210.txt : 20060214 0000909012-06-000210.hdr.sgml : 20060214 20060214155111 ACCESSION NUMBER: 0000909012-06-000210 CONFORMED SUBMISSION TYPE: 10KSB PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20051031 FILED AS OF DATE: 20060214 DATE AS OF CHANGE: 20060214 FILER: COMPANY DATA: COMPANY CONFORMED NAME: MERA PHARMACEUTICALS INC CENTRAL INDEX KEY: 0000837490 STANDARD INDUSTRIAL CLASSIFICATION: SERVICES-COMMERCIAL PHYSICAL & BIOLOGICAL RESEARCH [8731] IRS NUMBER: 043683628 STATE OF INCORPORATION: DE FISCAL YEAR END: 1031 FILING VALUES: FORM TYPE: 10KSB SEC ACT: 1934 Act SEC FILE NUMBER: 033-23460 FILM NUMBER: 06614612 BUSINESS ADDRESS: STREET 1: 73-4460 QUEEN KA'AHUMANU HWY. STREET 2: SUITE 110 CITY: KAILUA-KONA STATE: HI ZIP: 96740 BUSINESS PHONE: (808) 326-9301 MAIL ADDRESS: STREET 1: 73-4460 QUEEN KA'AHUMANU HWY. STREET 2: SUITE 110 CITY: KAILUA-KONA STATE: HI ZIP: 96740 FORMER COMPANY: FORMER CONFORMED NAME: AQUASEARCH INC DATE OF NAME CHANGE: 19920703 10KSB 1 t302361.txt ANNUAL REPORT UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, D.C. 20549 ------------------ FORM 10-KSB (X) ANNUAL REPORT UNDER SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year ended October 31, 2005 Commission file number 333-107716 ------------------ MERA PHARMACEUTICALS, INC. (NAME OF SMALL BUSINESS ISSUER IN ITS CHARTER) ------------------ DELAWARE 04-3683628 (State or other jurisdiction of (I.R.S. Employer incorporation or organization) Identification No.) 73-4460 QUEEN KA'AHUMANU HIGHWAY, SUITE 110, KAILUA-KONA, HAWAII 96740 (Address of principal executive offices) (Zip Code) Issuer's telephone number (808) 326-9301 Securities registered under Section 12(g) of the Exchange Act: NONE Check whether the issuer is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. ( ) NOTE - Checking the box above will not relieve any registrant required to file reports pursuant to Section 13 or 15 (d) of the Exchange Act from their obligations under those Sections. ================================================================================ 1 MERA PHARMACEUTICALS, INC. (the "Company" or "Mera") 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[ ] Check if there is no disclosure of delinquent filers pursuant to Item 405 of Regulation S-B contained in this form, and no disclosure will be contained, to the best of registrant's knowledge, in definitive proxy or information statements incorporated by reference in Part III of this Form 10-KSB or any amendment to this Form 10-KSB. [X] Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes [ ] No [X] Mera Pharmaceuticals' revenues for its most recent fiscal year: $387,972. The aggregate market value of the common equity held by non-affiliates computed by reference to the price at which the stock was sold, or the average bid and asked prices of such stock as reported on the NASD Electronic Bulletin Board, as of January 27, 2006, is $5,952,835. (ISSUERS INVOLVED IN BANKRUPTCY PROCEEDINGS DURING THE PAST FIVE YEARS) Check whether the issuer has filed all documents and reports required to be filed by Section 12, 13 or 15(d) of the Exchange Act after distribution of securities under a plan confirmed by a court: [X] Yes [ ] No The number of shares outstanding of common equity, as of October 31, 2005, was 467,637,161 shares of Common Stock, $0.0001 par value. Documents Incorporated by Reference: None Transitional Small Business Disclosure Format (check one): [ ] Yes [X] No 2 PART I THIS ANNUAL REPORT ON FORM 10-KSB CONTAINS CERTAIN FORWARD-LOOKING STATEMENTS WITHIN THE MEANING OF SECTION 21E OF THE SECURITIES EXCHANGE ACT OF 1934, AS AMENDED, INCLUDING STATEMENTS THAT INDICATE WHAT WE "BELIEVE", "EXPECT" AND "ANTICIPATE" OR SIMILAR EXPRESSIONS. THESE STATEMENTS INVOLVE KNOWN AND UNKNOWN RISKS, UNCERTAINTIES AND OTHER FACTORS WHICH MAY CAUSE OUR ACTUAL RESULTS, PERFORMANCE OR ACHIEVEMENTS TO DIFFER MATERIALLY FROM THOSE EXPRESSED OR IMPLIED BY SUCH FORWARD-LOOKING STATEMENTS. SUCH FACTORS INCLUDE, AMONG OTHERS, THE INFORMATION CONTAINED UNDER THE CAPTION "PART II, ITEM 6. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONS AND RESULTS OF OPERATIONS" AND ELSEWHERE IN THIS ANNUAL REPORT. YOU SHOULD NOT PLACE UNDUE RELIANCE ON THESE FORWARD-LOOKING STATEMENTS, WHICH REFLECT OUR MANAGEMENT'S ANALYSIS ONLY AS OF THE DATE OF THIS ANNUAL REPORT. WE UNDERTAKE NO OBLIGATION TO PUBLICLY RELEASE THE RESULTS OF ANY REVISION OF THESE FORWARD-LOOKING STATEMENTS. YOU ARE STRONGLY URGED TO READ THE INFORMATION SET FORTH UNDER THE CAPTION "PART II, ITEM 6, MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITIONS AND RESULTS OF OPERATION - RISK FACTORS" FOR A MORE DETAILED DESCRIPTION OF THESE SIGNIFICANT RISKS AND UNCERTAINTIES. ITEM 1. DESCRIPTION OF THE BUSINESS HISTORY Mera Pharmaceuticals, Inc. is the successor issuer to Aquasearch, Inc. (the "Predecessor"), which was incorporated in Colorado in 1987 for the purpose of developing useful products from aquatic microorganisms and making their production economically feasible. On July 25, 2002, the Predecessor merged with and into Mera Pharmaceuticals, Inc., a Delaware corporation formed in June 2002 for the purpose of changing the corporation's name to Mera Pharmaceuticals, Inc. and changing its state of incorporation from Colorado to Delaware (the "Reincorporation Merger"). Mera Pharmaceuticals continues the operations and business of the Predecessor. Each share of the Predecessor's common stock outstanding at the time of the Reincorporation Merger was exchanged for one share of common stock of Mera. Following the Reincorporation Merger, the former stockholders of the Predecessor continued to own 100% of the Company's issued and outstanding capital stock. On September 16, 2002, Aqua RM Co., Inc., a privately-held, non-operating Delaware corporation established specifically for the purpose of facilitating the Predecessor's reorganization under Chapter 11 of the U.S. Bankruptcy Code ("Aqua RM"), merged with and into the Company (the "Reorganization Merger"). The Company was the surviving corporation of the Reorganization Merger. Each share of Aqua RM common stock outstanding at the time of the Reincorporation Merger was exchanged for 100 shares of the Company's common stock. Following the Reorganization Merger, former Aqua RM stockholders held approximately 68% of the Company's common stock. The Reorganization Merger was the last material event in the fulfillment of the Company's Chapter 11 Plan of Reorganization. OVERVIEW OF THE COMPANY'S BUSINESS The Company develops and commercializes natural products derived principally from microalgae using our patented photobioreactor technology known as the Mera Growth Module ("MGM"). 3 Microalgae are a diverse group of microscopic plants estimated to consist of more than 30,000 species. They have a wide range of physiological and biochemical characteristics. Microalgae produce many different substances and bioactive compounds that have existing and potential applications in a variety of commercial areas, including human nutrition, pharmaceuticals, and other high value commodities. The major challenge to commercial exploitation of microalgae has been the availability of photobioreactors large enough to achieve commercial production levels at an economic cost. A photobioreactor is a fermentation system that is used to grow photosynthetic organisms. As late as the mid-1990s, most photobioreactors were used exclusively for research, and few exceeded more than 50 gallons (180 liters) in capacity. At more than 6,000 gallons (25,000 liters), our proprietary MGM is one of the largest photobioreactors in existence - and one of the few photobioreactors used for commercial production of microalgae. In addition, the MGM incorporates a very high level of computerized process control, resulting in a higher degree of reproducible performance at high efficiency levels. This increased reliability is due in large measure to the use of turbulence to control the exposure of the algae to light and nutrients at a frequency that improves yields. Mera owns the basic patent for use of turbulence in this way. Our patents, proprietary process controls and the very low cost of constructing the MGM make the MGM very advanced, cost-effective and scalable. The Company has used its advantage in photobioreactor technology in the production and marketing of its first commercial product, ASTAFACTOR(R), a nutraceutical and source of natural astaxanthin. Natural astaxanthin, a carotenoid found in many species of fish and seafood (it gives wild salmon its distinctive color), has long been recognized as a valuable nutritional supplement. The Company's development of the MGM has enabled it to produce astaxanthin for commercial distribution at an affordable cost and introduce its newest product, SALMONESSENTIALS, a proprietary combination of astaxanthin and Omega-3 fatty acids. The Company's business strategy is to exploit its leading position in microalgae cultivation technology to expand the sales of ASTAFACTOR(R) AND SALMONESSENTIALS while preserving margins. We also plan to develop and introduce additional microalgae-based nutritional products to the marketplace. Should the company acquire the capital needed to do so, we may elect to go forward with plans to identify and develop prescription pharmaceutical products based on algal extracts to treat infectious and proliferative diseases. We face significant potential competition for ASTAFACTOR(R). We expect that other nutraceutical products that the Company may launch in the future will face meaningful competition as well, although at present we are not aware of a product that combines the same ingredients as SALMONESSENTIALS in a single product. Astaxanthin is also widely used in the animal feed industry, primarily as a coloring agent. We have decided to forego engaging directly in marketing or distribution of AQUAXAN(R), our animal feed product, due to the low profit margins that it affords. More broadly, we do not believe that any commercial entity has developed a photobioreactor that matches the MGM's combination of large size, low cost and level of process control or sustained performance for a wide variety of aquatic species, although a number of other companies are developing closed environment production systems for marine micro-organisms. We believe that competition in each of these areas may increase significantly over time as alternatives to the Company's patented technology are developed. For more information on our competition, see "Risk Factors; Risks Related to Our Industry." 4 Mera Pharmaceuticals' patents and intellectual property include issued patents relating to the MGM and general processes for cultivating microalgae in photobioreactors. The Company intends to continue efforts to expand its portfolio of patents and technical know-how and believes that intellectual property relative to aquatic organism biotechnology will become much more important, challenging and complex in the future. We intend to develop intellectual property as a means of maintaining an advantage over our competitors. Government regulation and product testing are strong factors in the markets for the products we are developing and producing. Our products, both current and future, are subject to regulation by the U.S. Food and Drug Administration or similar agencies in foreign countries and may require extensive testing for safety and efficacy before being released for sale. The Company currently manufactures its products at a four-acre research, development and production facility at the Hawaii Ocean Science and Technology Business Park in Kailua-Kona, Hawaii. The facility is ideally located for our research and development and the commercial production of microalgae. We have access to large volumes of deep ocean water (used for temperature control) in a stable tropical climate with plentiful sunlight, conditions that are well suited to microalgae cultivation. Although Hawaii's distance from many markets increases certain costs of operation, on balance there are few locations, domestic or international, that are as well suited to our cultivation processes. In addition to the development and production of our own products, the Company is also actively seeking research collaborations with other enterprises to demonstrate the economic feasibility of producing valuable substances that they have identified in microalgae. We engaged in such a collaboration during 2005 with a biopharmaceutical company that has technology that enables it to produce human proteins in algae. Other such collaborations will be sought to expand the applications of Mera's technology. We will also explore licensing opportunities for the technology where that makes economic sense. RATIONALE FOR MICROALGAE AS A SOURCE OF COMMERCIAL PRODUCTS Microalgae represent approximately half of all plant species. Many of their characteristics make them attractive for commercial production. 1) UNTAPPED RESOURCE o Fewer than 5,000 out of the estimated total of 30,000 species are believed to have been cultivated in the laboratory o Fewer than 1,000 species are believed to have been carefully investigated for new substances o Fewer than 10 species have been cultivated at commercial scale 2) DEMONSTRATED SOURCE OF NEW SUBSTANCES o Several hundred new bioactive substances have been discovered in the small number of microalgae that have been researched to date 3) SOURCE OF VALUABLE SUBSTANCES o Many molecules derived from microalgae are already known to be valuable for use as enzymes, pigments, vitamins, nutraceuticals, pharmaceuticals and the like o Bioactive compounds extracted from microalgae have substantial potential value as pharmaceuticals 5 4) RAPID GROWTH RATE o Growth rates for microalgae species range from about 1 to 10 divisions per day o Growth rates for these plants are, in general, faster than any other plants 5) LOW COST OF RAW MATERIALS o Water, sunlight, fertilizer and carbon dioxide, the principal raw materials used in cultivation, are plentiful and economical THE COMPANY'S MGM TECHNOLOGY FEATURES OF MGM TECHNOLOGY. The key features of MGM technology are sterility, size (25,000 liters) and enhanced control over virtually all environmental factors affecting growth rates and metabolic activity, such as temperature, pH, nutrient mix and distribution, light, pests and contaminants. This combination of size and control has been the goal of international research efforts for the past several decades. The MGM has achieved that goal. Although it is among the largest photobioreactors ever operated, the MGM's patented technology allows a far greater degree of control of the growth environment than has been possible in systems a tenth, or even one-hundredth, that size. PROCESS CONTROL SYSTEMS - THE KEY TO REPRODUCIBLE PERFORMANCE. In order to take greatest advantage of the MGM technology, we have developed proprietary, computerized process control systems for the MGM that make it possible to conduct the following operations automatically: o monitoring of key production variables at intervals more frequent than one minute; o data archiving for comprehensive analysis of system performance; o automated control of all operations performed more than once a day (both a process control improvement and labor cost saving); o immediate alarm system for any system component not operating within parameters; and o automated maintenance for hundreds of system components, reducing failures and preventing contamination. Increasing control over processes has produced several benefits. Product quality and consistency have gone up, the scale at which processes are controllable has increased and the amount of capital and labor required to accomplish a given amount of production has decreased. This combination of effects translates into enhanced efficiency, which translates into lower cost per unit of production and higher margins. COMPETITIVE PRODUCTION SYSTEMS. We are not aware of any closed system photobioreactor that compares favorably with the MGM. Most photobioreactors are operated only at an experimental scale. There are other systems that cultivate microalgae at larger than experimental scale. However, we believe that the advantages of the MGM over these other systems include size, versatility, cost-effectiveness and higher yields. We believe that an important advantage of the MGM over any competing technology is the ability to achieve a high degree of control over all critical environmental factors for microalgae, except those species that proliferate under the most extreme conditions. As a result, it can be used in efficiently cultivating hundreds, even thousands, of microalgal species at commercial scale. We do not believe any other large scale system has such flexibility and versatility, which are important factors in the development of new products from a variety of microalgal species. 6 PRODUCTS FROM MICROALGAE (1) ASTAFACTOR(R) BRAND OF ASTAXANTHIN - OUR FIRST COMMERCIAL PRODUCT DESCRIPTION AND PROPERTIES. Astaxanthin is a red-orange, carotenoid pigment. It is closely related to other well-known carotenoids, such as beta-carotene, lutein and zeaxanthin. All of these molecules are antioxidants, substances shown by research to protect health, but astaxanthin is among the strongest. Some studies indicate that it is ten times more potent than beta-carotene, and more than 500 times more potent than vitamin E - another well known and commonly used antioxidant. Astaxanthin is one of the main pigments in aquatic animals. It gives the flesh of salmon its characteristic color, for example. Yet, it is far more than a pigment. Astaxanthin has been shown to perform many essential biological functions, including: o protecting against the harmful effects of UV light; o enhancing the immune response; o protecting against the oxidation of essential polyunsaturated fatty acids; o stimulating pro-vitamin A activity and vision; o improving reproductive capacity; and o assisting in communication. In species like salmon or shrimp, astaxanthin is essential to normal growth and survival and has been attributed vitamin-like properties. Some of these unique properties are also effective in mammals. Studies in human and animal models suggest that astaxanthin may substantially improve human health by virtue of its antioxidant properties, protecting vision, reducing inflammation (recently shown to be a major factor in heart attacks) slowing neurodegenerative diseases and preventing certain cancers. THE ASTAFACTOR(R) MARKET. We believe that the market for ASTAFACTOR(R) is likely to expand rapidly over the next few years. There is growing evidence in the scientific and medical literature that astaxanthin contributes meaningfully to the general well-being of humans. Although we face competition in this market, we believe that our technology will give us significant cost and quality advantages over our competitors in our effort to capture a significant share of this growing market. We began sales of ASTAFACTOR(R) in Hawaii on March 30, 2000, and Longs Drugs agreed to expand our distribution to San Diego County in the fall of 2001. We continued to expand our retail distribution, first into Longs Drugs system wide, and then into approximately 1200 Sav-On and Osco drug stores. However, our experience has shown that effectively promoting retail sales of astaxanthin requires longer format advertising than can be readily used in typical retail advertising. For that reason, the Company has returned its focus to the Hawaiian market, which offers sufficient revenue potential to support the cost of broader domestic retail distribution. We are also devoting greater energy to international markets, which our information indicates are generally much more receptive to these kinds of products. We are also increasing our emphasis on private label sales. This distribution channel offers lower margins than branded product sales, but it does not involve advertising and marketing expenses, which are born by the private label seller. As a result, this channel can contribute meaningfully to profitability. The Company has also begun to pursue the sale of raw materials, the extract and beadlet forms of astaxanthin, to end users that incorporate these materials into products that they make and distribute. 7 (2) SALMONESSENTIALS During fiscal year 2004 the Company introduced an extension of its ASTAFACTOR(R) line, SalmonEssentials. This new product offers a unique combination of astaxanthin and Omega-3 fatty acids, the two most important nutritional components available from wild salmon, which is widely recognized as one of nature's most healthful foods. This product offers all of the health benefits associated with ASTAFACTOR(R) and adds to them the significant benefits of including Omega-3 fatty acids in your diet, such as improved cardiac health. Omega-3s also help reduce inflammation, adding to that important benefit of ASTAFACTOR(R). We began marketing SALMONESSENTIALS(TM) near the middle of fiscal year 2004, launching the product initially through our Hawaiian retail distribution system. We have also made SALMONESSENTIALS(TM) available through our web site. The Company is currently contemplating a number of strategies to expand the distribution of what we believe is a product with significant potential. (3) PRODUCT LINE EXPANSION The Company is currently evaluating other product line extensions for its ASTAFACTOR(R) product and is also exploring additional microalgae sources for development as nutraceutical products. Among these is zeaxanthin, a carotenoid accumulated by certain microalgal species (for example, cyanobacteria and rhodophytes). Subnormal levels of zeaxanthin are associated with macular degeneration, the most frequent cause of blindness among the elderly. We believe that many more nutraceutical products could be developed from microalgae, but they remain unexamined and unexploited because there has been no feasible way to grow them at a large enough scale. The MGM opens a path to this untapped resource by combining effective, reproducible control with commercial scale production. (4) PHARMACEUTICAL DRUG DISCOVERY The Company has always appreciated the potential to discover pharmaceuticals that are based on bioactive compounds produced by aquatic plants. However, we are not currently engaged in any drug discovery activity, and we do not anticipate doing so during fiscal year 2006. We do remain open to collaborations with other companies that may wish to develop products using our patented technology, and we have had such discussions with a number of parties. We engaged in one such collaboration during the last calendar quarter of 2005. DEPENDENCE ON KEY CUSTOMERS Our business currently depends heavily on key distribution relationships in Hawaii. Sales to our largest customer, Longs Drugs, continues to represent a significant portion of our product sales. However, this percentage is decreasing as a result of an increase in direct sales, distribution through several additional retail chains in Hawaii, an increase in private label sales domestically, the move to distribute internationally and other measures we have taken to broaden distribution. OUR STRATEGIES Our objective is to sustain Mera Pharmaceuticals' global leadership in microalgae cultivation technology and to identify, optimize and directly commercialize high-value microalgae products for human healthcare markets worldwide. We have several strategies to achieve these goals. 8 1) INCREASE SALES OF NUTRACEUTICAL PRODUCTS. The Company intends to increase sales of its current products, ASTAFACTOR(R) and SALMONESSENTIALS(TM), by expanding distribution within Hawaii as well as internationally through a variety of sales channels. It appears that awareness of the benefits of astaxanthin is growing in the marketplace, and once the benefits of our products are more fully understood by the general public, we will re-focus on entering national domestic retail chains with the potential for delivering high sales volumes at attractive margins and efficient distribution. Another element in our strategy to build revenues is to increase our level of sales of unbranded product, either in the form of raw materials or to private label sellers. We have identified ways to increase our production capacity so that the added revenues from these additional sources will contribute significantly to revenue and the potential to achieve profitability. We have also retained a broker to help us achieve sales of raw materials to nutritional supplement formulators. Additionally, the Company expects to continue research activities to identify and optimize additional microalgae nutraceutical products. We will also utilize the learning gained as a key subcontractor in a $2.4 million U.S. Department of Energy project to accelerate product development. 2) CONTINUALLY IMPROVE AND ENHANCE OUR CORE PLATFORM TECHNOLOGY. Our MGM technology led to the production of the first new commercial product derived from photosynthetic microalgae in over 25 years. We believe that our proprietary technologies and processes provide us with a significant competitive advantage over other known microalgae cultivation technologies. To the extent available, we intend to devote meaningful resources to continue to improve our underlying technology and our automated process control systems to increase product quality, yield and productivity per employee. 3) EXPAND STRATEGIC ALLIANCES. We intend to develop relationships with other companies who have products that will benefit from utilizing our technology under license. We believe that there is significant potential revenue associated with the licensing of our technology to other companies or in performing contract work for them utilizing our facilities or expanded facilities if justified. MANUFACTURING Our Kona facility has sufficient capacity to meet our current demand for product. However, we have recently completed negotiations with our landlord that will enable us to increase our production capacity by a factor of two, if needed. We have also engaged in an optimization effort that will enable us to produce greater amounts of product from the same land area. Still further capacity is available from cycle time reductions that can be achieved with modest capital investment. This ability to expand our production is sufficient to meet our projected needs for the foreseeable future. However, further expansion of the Kona facility is feasible, if demand for our products justifies doing so. RESEARCH AND DEVELOPMENT COSTS Research and development costs include salaries, development materials, plant and equipment depreciation and costs associated with operating our five-acre research and development/production facility. During the last two fiscal years, the Company has spent approximately $279,888 on research and development activities, none of which was borne directly by our customers. 9 MARKETING AND SALES The Company's marketing strategy for its nutraceutical products may vary depending on the specific product being sold and its target market, but that strategy is generally built on two fundamental tenets: 1) CREATE ALLIANCES WITH EFFICIENT, HIGH-QUALITY DISTRIBUTORS IN KEY U.S. REGIONAL AND INTERNATIONAL MARKETS AND SUPPORT THOSE DISTRIBUTORS WITH EFFECTIVE ADVERTISING AND PROMOTION TO THE CONSUMER. The Company currently markets ASTAFACTOR(R) AND SALMONESSENTIALS(TM) to mass retail outlets in Hawaii through distribution arrangements with established companies. We are also expanding our efforts to distribute internationally through existing distributors and outlets in Pacific Asian and other countries. 2) SELL ASTAFACTOR(R) AND SALMONESSENTIALS(TM) DIRECTLY TO THE CONSUMER. This approach allows us to reach consumers throughout the domestic market at the most attractive margins, since it eliminates distributor and retailer profits. Web-based and specialty media promotion are also used to reinforce our marketing efforts and product visibility to all consumers. We are building a customer data base that will enhance our ability to reach regular customers with new products as they are developed and come to market. COMPETITION The Company believes that its proprietary technology and process control systems and software give it a significant advantage relative to its competitors. However, there are a number of companies that are engaged in efforts to develop microalgae-based products that compete with ours, either directly or indirectly. We believe that original MGM technology was the first closed-system, process-controlled photobioreactor to be operated at commercial scales larger than 2,750 gallons (10,000 liters). We are now operating at a scale more than twice that (25,000 liters). We are aware of only three other companies in the world - Biotechna of Australia, Algatechnologies of Israel and MicroGaia of Hawaii - that claim to possess proprietary photobioreactor technology. Our information regarding these other systems is that they suffer from one or more disadvantages relative to the MGM. However, given that these organizations control the release of proprietary information regarding their systems, we are not in a position to confirm that assessment of our competitors' systems. COMPETITORS FOR ASTAFACTOR.(R) Producers of astaxanthin that compete with ASTAFACTOR(R), our nutraceutical astaxanthin product, include: MicroGaia, Inc.; Cyanotech Corporation; Algatechnologies and Minapro. MicroGaia, Inc. is a Hawaii-based subsidiary of Fuji Chemical Industries, Inc. that has established a market for its product in Japan. Cyanotech Corporation, Algatechnologies and Minapro also make astaxanthin-based nutraceutical products. Competition also comes from non-producers who acquire raw materials from the producers for distribution in the nutraceuticals market. Potential competitors include producers of the synthetic material as well. However, to our knowledge neither BASF, a large German chemical company, nor Hoffman-LaRoche, a large Swiss pharmaceutical company, both large global producers of synthetic astaxanthin, has indicated an interest in this market. Furthermore, we believe that consumers of nutraceuticals prefer products from natural sources to those from synthetic sources and will not pay premium prices for synthetics, even if they are available. We are aware of other companies that are interested in or are actually marketing nutraceutical astaxanthin which use a fermentation process. However, to our knowledge, only MicroGaia, , Cyanotech, Algatechnologies and Minapro produce the product from HAEMATOCOCCUS. We believe our production process has cost or quality advantages or both over all of those companies. 10 PATENTS, LICENSES AND PROPRIETARY TECHNOLOGY We rely upon a combination of patents, copyrights, trade secrets, know-how, continuing technological innovation and licensing opportunities to develop and maintain our competitive position. Our future prospects depend in part on our ability to obtain patent protection for our products and processes. We need to preserve our copyrights, trademarks and trade secrets. We also need to operate without infringing the proprietary rights of third parties. PATENTS. We have been awarded or have filed applications for roughly a dozen patents relating to various processes, including, but not limited to, the process and apparatus for the production of photosynthetic microbes and the method of control of microorganism growth processes. These patents are active in the United States and potentially other countries. The original duration of these patents varied from fifteen to twenty years from the date of filing or issuance, and the Company's current patents will be active for five to nine years, provided the maintenance fees associated with such patents are timely paid. The Company reassesses the value of each patent it holds at the time maintenance fees are due, and in cases where maintaining a patent is judged to be of no significant strategic value, we do not renew the patent. Other companies may have filed and in the future are likely to file patent applications that are similar or identical to ours. To determine the priority of inventions, we may have to participate in interference proceedings declared by the United States Patent and Trademark Office. Such proceedings could result in substantial costs to us. We cannot ensure that any such third-party patent application will not have priority over ours. Additionally, the laws of certain foreign countries may not protect our patent and other intellectual property rights to the same extent as the laws of the United States. Our future prospects also depend in part on our neither infringing on patents or proprietary rights of third parties nor breaching any licenses that may relate to our technologies and products. We cannot guarantee that we will not infringe on the patents, licenses or other proprietary rights of third parties. We have not conducted an exhaustive patent search, and we cannot ensure that patents do not exist or could not be filed that would have a material adverse effect on our ability to develop and market our products. There are many United States and foreign patents and patent applications in our area of interest. We attempt to control the disclosure and use of our proprietary technology, know-how and trade secrets under agreements with the parties involved. However, we cannot ensure that others will honor all confidentiality agreements. We cannot prevent others from independently developing similar or superior technology, nor can we prevent disputes that could arise concerning the ownership of intellectual property. TRADEMARKS AND SERVICE MARKS. The following trademarks and service marks have been registered or are claimed marks that the Company has not registered but as to which it believes it has established a common law right of use and as to which it has no information to the contrary. The registered trademark on ASTAFACTOR(R) is valid through March 2012, and the following other claimed marks that the Company believes it has established a common law right of use are valid for the standard period of duration, as provided in applicable common law: SALMONESSENTIALS(TM) AQUAXAN(R) MERA PHARMACEUTICALS(TM) MERA GROWTH MODULE(TM) (MGM) MERA PROCESS CONTROL SYSTEM(TM) (MPCS) MERA REMOTE DATA WEB ACCESS(TM) (RDWA) DRUGS FROM THE SEA(TM) 11 GOVERNMENT REGULATION AND PRODUCT TESTING Our current and potential products and our manufacturing and research activities are or may become subject to varying degrees of regulation by many government authorities in the United States and other countries. Such regulatory authorities could include the State of Hawaii Department of Health or Agriculture Department, the FDA, and comparable authorities in foreign countries. Each existing or potential microalgae product intended for human use that we develop or market, either directly or through licensees or strategic partners, may present unique regulatory problems and risks. Relevant regulations depend on product type, use and method of manufacture. The FDA regulates, in varying degrees and in different ways, dietary supplements, other food products, medical devices and pharmaceutical products. Regulations govern manufacture, testing, exporting, labeling and advertising. Prescription pharmaceuticals and certain types of medical devices are regulated more vigorously than dietary supplements. Any products we develop for use in human nutrition, pharmaceuticals or cosmetics could require that we develop and adhere to Good Manufacturing Practices ("GMP"), as suggested by the FDA, European standards and any other applicable standards mandated by federal, state, local or foreign laws, regulations and policies. Our current cultivation and processing facilities and procedures are not yet required to comply with GMP or ISO standards, although our contract extraction and encapsulation facilities must meet GMP standards, and they do. We believe we are prepared to meet these requirements more broadly when necessary. The Company currently distributes ASTAFACTOR(R) AND SALMONESSENTIALS(TM) in the United States, and in certain foreign countries, including Korea and Malaysia. We also intend to expand our distribution internationally to include China, the European Union, Japan, Canada and Australia, as well as others. Regulatory approval requirements vary by country. We believe the approval process for ASTAFACTOR(R) in most countries will come under their "natural" status and that it will be approved relatively quickly; however, we can provide no assurances in this regard. EMPLOYEES. As of October 31, 2005, the Company hadfive (5) full-time employees. We consider relations with our employees to be good. None of our employees is covered by a collective bargaining agreement. ITEM 2. DESCRIPTION OF PROPERTIES. Our research, development and production facilities are located in the Hawaii Ocean Science and Technology (HOST) Business Park in Kailua-Kona, Hawaii. Our facility currently consists of approximately four acres containing a number of MGMs, finishing ponds, a processing facility, several laboratories, administrative offices and additional space for production and research and development. All our products are currently produced at this facility. We have recently completed negotiations to acquire additional acreage adjacent to our facility, which will enable us to increase our production capacity as demand for our products and services increases. We currently occupy this facility on a month-to-month basis, but we have reached agreement on a long-term lease that requires finalizing and execution. ITEM 3. LEGAL PROCEEDINGS The Company is not currently a party to any pending legal proceedings, nor is any of its property the subject of a pending legal proceeding. 12 ITEM 4. SUBMISSION OF MATTERS TO A VOTE OF SECURITY HOLDERS No matters were submitted to matters to a vote of security holders during the fourth quarter of our 2005 fiscal year. PART II ITEM 5. MARKET FOR REGISTRANT'S COMMON EQUITY AND RELATED STOCKHOLDER MATTERS MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS Our common stock is traded in the over-the-counter market on the NASD "Electronic Bulletin Board" (Symbol: "MRPI"). The following table shows for the periods indicated the high and low bid quotations for our common stock, as reported by financial reporting services. These quotations are believed to represent inter-dealer quotations without adjustment for retail mark-up, mark-down or commissions, and may not represent actual transactions. PERIOD HIGH BID LOW BID - ---------------- -------- ------- FISCAL 2003 First Quarter $0.08 $0.03 Second Quarter $0.05 $0.03 Third Quarter $0.10 $0.05 Fourth Quarter $0.10 $0.04 FISCAL 2004 First Quarter $0.05 $0.03 Second Quarter $0.035 $0.029 Third Quarter $0.032 $0.023 Fourth Quarter $0.03 $0.016 FISCAL 2005 First Quarter $0.01 $0.02 Second Quarter $0.011 $0.015 Third Quarter $0.012 $0.04 Fourth Quarter $0.035 $0.012 As of October 31, 2005, we had approximately 780 record holders of our 467,637,161 outstanding shares of common stock. 13 SECURITIES AUTHORIZED FOR ISSUANCE UNDER EQUITY COMPENSATION PLANS In November 2004 the Board of Directors rescinded the previously adopted 2003 Stock Option Plan and adopted in its place the 2004 Stock Option Plan. That plan authorizes the issuance of options to purchase up to 60,000,000 shares of the Company's common stock. The Board of Directors granted options to purchase approximately 48,500,000 shares of stock, with vesting credit having been given for past service to the company dating back to the effective date of our reorganization. As of October 31, 2005, 35,390,492 of the options had vested, and 60,750 had been exercised. DIVIDEND POLICY We have never paid cash dividends on our capital stock. We currently intend to retain all available funds to operate and expand our business. We do not anticipate paying any cash dividends in the foreseeable future. RECENT SALES OF UNREGISTERED SECURITIES In December 2003 the Company issued 18,181,818 shares of common stock at a price of $0.11 per share to a Delaware limited liability company. That company is managed in part by persons who, at the time of the investment, were shareholders, officers and directors of the Company, and one of them continues to be. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In October 2004 the Company issued a note for $20,000 to a director who loaned the Company that amount. The terms of the note included interest payable at the rate of 6% and a maturity date of December 31, 2004. That loan has since been repaid in full. As a part of the compensation payable by the Company to the lender, the Company issued warrants to purchase 100,000 shares of the Company's common stock. The warrants have an exercise price of $0.02 per share and a term of five years. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In November 2004 the Company issued a promissory note to a director of the Company, in consideration for a loan of $17,000 to the Company. As part of the compensation for the loan, the Company issued to the lender detachable warrants to purchase 85,000 shares of the Company's common stock at a price of $0.02 per share, which warrants have a term of five years. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In November 2004 the Company issued a promissory note to a director of the Company, in consideration for a loan of $10,000 to the Company. As part of the compensation for the loan, the Company issued to the lender detachable warrants to purchase 50,000 shares of the Company's common stock at a price of $0.02 per share, which warrants have a term of five years. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In November 2004 the Company issued a promissory note to an investor, in consideration for a loan of $30,000 to the Company. As part of the compensation for the loan, the Company issued to the lender detachable warrants to purchase 150,000 shares of the Company's common stock at a price of $0.02 per share, which warrants have a term of five years. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). 14 In December 2004 the Company issued 7,954,545 shares of its common stock at a price of $0.04 per share to a limited liability company in fulfillment of an earlier subscription to purchase stock. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In December 2004, the Company issued 1,008,798 shares of its common stock to an investor at a price of $0.11 per share. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In December 2004, the Company issued 945,748 shares of its common stock to an investor at a price of $0.11 per share. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In March 2005 the Company issued a total of 700,000 shares of common stock to consultants in compensation for their services. These issuances were exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In March 2005 the Company issued 2,614,370 shares of its common stock to Aquasearch Investment Partners, a general partnership, in exchange for cancellation of a debt in the amount of $26,143.70 owed to it under a factoring agreement previously entered into, or an effective price of $0.01 per share. Gregory F. Kowal, the chairman of the Company's board of directors, is a general partner of Aquasearch Investment Partners. This issuance was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In March 2005 the Company issued 400,000 shares of stock to Anthony E. Applebaum, the Company's principal accounting and financial officer, in exchange for his forgiveness of the amount of $4,000 owed to him for services rendered, or an effective per share price of $0.01. This issuance was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In March 2005 the Company issued 87,298, 1,354,028 and 1,582,771 to Gregory F. Kowal, Daniel P. Beharry and Kenneth Crowder, respectively, in exchange for their forgiveness of debts in the amount of $872.98, $13,540.28 and $15,827.71 owed to them by the Company for expenses incurred by them on the Company's behalf. The effective per share price of these issuances was $0.01 per share. Messrs. Kowal, Beharry and Crowder are all members of Mera's board of directors. These issuances were exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In March 2005 the Company issued 10,000,000 shares of its common stock to an investor in exchange for investment of $100,000, a per share price of $0.01 per share. This issuance was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In March and April 2005 the Company issued 6,810,770 shares to a director in exchange for total investment of $68,107.70, a per share price of $0.01. This issuance was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In September and October 2005, the Company issued promissory notes to a director of the Company in the amount of $10,000 in exchange for loans totaling that amount made by the director to the Company for use as working capital. 15 In September and October 2005, the Company issued promissory notes to a director of the Company in the amount of $25,400 in exchange for loans totaling that amount made by the director to the Company for use as working capital. In December 2005 the Company issued 11,538,462 shares of common stock to investors in exchange for total investment of $150,000, a per share price of $0.013. This issuance was exempt from registration under the securities act of 1933, as amended, pursuant to Section 4(2). ITEM 6. MANAGEMENT'S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATION OVERVIEW Since inception, our primary operating activities have consisted of basic research and development and production process development, recruiting personnel, purchasing operating assets and raising capital. From September 16, 2002, the effective date of our reorganization, through October 31, 2005, we had an accumulated deficit of $5,143,465. Our losses to date have resulted primarily from costs incurred in research and development and from general and administrative expenses associated with operations. We expect to continue to incur operating losses for at least the 2006 fiscal year and perhaps beyond. We expect to have quarter-to-quarter and year-to-year fluctuations in revenues, expenses and losses, some of which could be significant. We have a limited operating history. An assessment of our prospects should include the technology risks, market risks, expenses and other difficulties frequently encountered by early-stage operating companies, and particularly companies attempting to enter competitive industries with significant technology risks and barriers to entry. We have attempted to address these risks by, among other things, hiring and retaining highly qualified persons and expanding our product offering while increasing our efforts to expand sales internationally and improving our production efficiencies and minimizing our overhead. However, our best efforts cannot guarantee that we will overcome these risks in a timely manner, if at all. CRITICAL ACCOUNTING POLICIES This discussion and analysis of the Company's financial condition and results of operations is based upon our financial statements, which have been prepared in accordance with accounting principles generally accepted in the United States. The preparation of these financial statements requires the Company to make estimates and judgments that affect the reported amounts of assets, liabilities, revenue and expenses and related disclosure of contingent assets and liabilities. On an on-going basis, the Company evaluates its estimates. The Company bases its estimates on historical experience and on other assumptions that it believes to be reasonable under the circumstances, the results of which form the basis for making judgments about the carrying values of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. CASH AND CASH EQUIVALENTS The Company considers all highly liquid debt securities purchased with original or remaining maturities of three months or less to be cash equivalents. 16 INVENTORIES Inventories are stated at the lower of cost or market. The Company determines cost on a first-in, first-out basis. On an ongoing basis, the company tests its inventory for obsolescence. During 2004 the Company began recording an allowance for excess inventory, reflecting the fact that we may not be able to sell all of the inventory that we have on hand if we do not increase our rate of sales. REVENUE RECOGNITION Product revenue is recognized upon shipment to customers. Contract services revenue is recognized as services are performed on a cost reimbursement basis. PLANT AND EQUIPMENT Plant and equipment are stated at cost. Depreciation is provided on the straight-line method over the estimated useful lives of the assets. IMPAIRMENT OF LONG-LIVED ASSETS AND LONG-LIVED ASSETS TO BE DISPOSED OF In August 2001, the Financial Accounting Standards Board ("FASB") issued Statement of Financial Accounting Standards ("SFAS") No. 144 "Accounting for the Impairment or Disposal of Long-Lived Assets" which supersedes both SFAS No. 121, "Accounting for the Impairment of Long-Lived Assets and for Long-Lived Assets to Be Disposed Of" and the accounting and reporting provisions of Accounting Practice Bulletin ("APB") Opinion No. 30, "Reporting the Results of Operations - Reporting the Effects of Disposal of a Segment of a Business, and Extraordinary, Unusual and Infrequently Occurring Events and Transactions," for the disposal of a segment of a business (as previously defined in that opinion). This statement establishes the accounting model for long-lived assets to be disposed of by sale and applies to all long-lived assets, including discontinued operations. This statement requires those long-lived assets be measured at the lower of carrying amount or fair value less cost to sell, whether reported in continuing operations or discontinued operations. Therefore, discontinued operations will no longer be measured at net realizable value or include amounts for operating losses that have not yet occurred. The Company adopted SFAS No. 144 in the fiscal year ending October 31, 2002. SFAS No. 144 retains the fundamental provisions of SFAS No. 121 for recognizing and measuring impairment losses on long-lived assets held for use and long-lived assets to be disposed of by sale, while also resolving significant implementation issues associated with SFAS No. 121. The Company adopted SFAS No. 144 in its evaluation of the fair value of certain assets in connection with the adoption of fresh-start accounting. STOCK ISSUED FOR SERVICES The value of stock issued for services is based on management's estimate of the fair value of the Company's stock at the date of issue or the fair value of the services received, whichever is more reliably measurable. RESEARCH AND DEVELOPMENT Research and Development costs are expensed as incurred. 17 INCOME TAXES The Company uses the asset and liability method of accounting for income taxes as required by SFAS No. 109 "Accounting for Income Taxes". SFAS No. 109 requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of certain assets and liabilities. Since its inception, the Company has incurred net operating losses. Accordingly, no provision has been made for income taxes. FRESH START ACCOUNTING On September 16, 2002, the Company adopted "fresh start" accounting as a result of the completion of bankruptcy proceedings. Accordingly, all assets and liabilities were restated to reflect their respective fair values as of that date. GOODWILL AND OTHER INTANGIBLE ASSETS The Company accounts for intangible assets in accordance with SFAS 142. Generally, intangible assets with indefinite lives, and goodwill, are no longer amortized; they are carried at lower of cost or market and subject to annual impairment evaluation, or interim impairment evaluation if an interim triggering event occurs, using a new fair market value method. Intangible assets with finite lives are amortized over those lives, with no stipulated maximum, and an impairment test is performed only when a triggering event occurs. Such assets are amortized on a straight-line basis over the estimated useful life of the asset. Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. If the fair value is less than the carrying amount of the asset, an impairment loss is then recognized. DISCLOSURES ABOUT FAIR VALUE OF FINANCIAL INSTRUMENTS The carrying amounts of the Company's financial instruments, including cash, accounts receivable, notes receivable, accounts payable and notes payable are deemed to approximate fair value due to their short-term nature. RESULTS OF OPERATIONS The following discussion and analysis provides information that the Company's management believes is relevant to an assessment and understanding of our results of operations and financial condition. This discussion should be read in conjunction with the financial statements and footnotes, which appear elsewhere in this prospectus. RESULTS OF OPERATIONS FOR THE FISCAL YEAR ENDED OCTOBER 31, 2005 COMPARED TO THE FISCAL YEAR ENDED OCTOBER 31, 2004 REVENUES. During the years ended October 31, 2005 and 2004, product sales totaled $289,000 and $672,000, respectively. During fiscal 2005, these sales were generated principally through through direct sales, with a portion being attributed to international distribution of our products and some sales of raw materials. $200,000 of the product revenue for 2004 resulted from the elimination of an entry for deferred revenue that we had carried previously. That adjustment was based on a determination that the Company would not be required to deliver additional product in order to recognize that revenue. After adjustment for the deferred revenue entry, product revenue decreased year-over-year by about 39%. This decrease is attributed to a decline in orders placed by our wholesale distributor. 18 We earned revenues of $99,000 and $181,000 for the years ended October 31, 2005 and 2004, respectively, from contract work. The majority of this revenue came from a subcontract for work on a U.S. Department of Energy ("DOE") project, which ended part way through the year. The Company began performing additional contract work in the second half of 2005, which continued into the first quarter of 2006 and may continue beyond that date. Royalty revenues for the years ended October 31, 2005 and 2004 were $0 and $56,000, respectively. Royalty revenues included amounts received from another company based on sales of its products. The royalties ended during the first quarter of 2004. EXPENSES. Overall operating expenses were $1,701,370 in 2005 compared with $2,270,000 in fiscal 2004, a decline of 25%. This reduction resulted principally from continuing efforts to control costs. COST OF PRODUCTS SOLD. Cost of products sold include manufacturing and production costs associated with ASTAFACTOR(R) and SALMONESSENTIALS, as well as the cost of sales of raw materials and certain other products. Expenses decreased in the categories of cost of products sold, due principally to the decrease in product revenues discussed above, to $297,186 in 2004 versus $675,000 in 2004. COST OF CONTRACT SERVICES. Cost of contract services includes costs associated with the U.S. Department of Energy project and other contract work that the Company performs. During the years ended October 31, 2005 and 2004, the cost of contract services was $122,613 and $330,000 respectively. The changes in costs under this category relate to changes in the number of personnel assigned to perform contract work for the Company at various times and the period of time for which that work was performed. RESEARCH AND DEVELOPMENT COSTS. Research and development costs include salaries, research supplies and materials and other expenses related to product development, exclusive of those costs for which the company is reimbursed. Research and development costs for the year ended October 31, 2005 were $169,000 as compared to $111,000 for 2004. The increase in costs in fiscal year 2005 resulted from a shifting of resources to various product development activities that the Company engaged in during 2005. GENERAL AND ADMINISTRATIVE EXPENSES. General and administrative expenses consist principally of salaries, fees for professional services and promotional and marketing expenses related to ASTAFACTOR(R). General and administrative expenses for the fiscal year 2005 were $534,000 versus $673,000 in 2004, a decline of about 21%. This decrease was due to the company's continuing efforts to control overhead costs. INTEREST EXPENSE. For the years ended October 31, 2005 and 2004, interest expense was $10,000 and $14,000, respectively. The amount of interest expense incurred in any particular period varies with the amount of debt outstanding and the rate of interest payable on that debt. PROVISION FOR EXCESS AND OBSOLETE INVENTORY. During fiscal 2004, the Company began to carry a new expense item, a provision for excess and obsolete inventory totaling $323,000. This item reflects the possibility that the Company may not be able to sell all of its current inventory if it does not appreciably increase its rate of product sales. That provision was increased to $349,000 for fiscal 2005. 19 LIQUIDITY AND CAPITAL RESOURCES We have financed our operations until now through public and private sales of debt and equity securities and debt instruments, together with revenues from product sales, contract work and royalties. During the years ended October 31, 2005 and 2004, we raised approximately $560,000 and $1.3 million, respectively, of net proceeds from the sale of shares of common stock and/or the issuance of debt in private placement transactions. During fiscal 2005, cash used in operating activities was approximately $567,000 compared with $1.25 million for fiscal 2004. The decrease in cash used resulted from conducting production operations at a decreased level and the continued efforts to reduce overall costs. Subsequent to the end of fiscal year 2005, the Company received additional equity investment of $150,000 in a private offering. RISK FACTORS YOU SHOULD CAREFULLY CONSIDER THE RISKS DESCRIBED BELOW, IN ADDITION TO ALL OTHER INFORMATION INCLUDED IN THIS REPORT, BEFORE YOU DECIDE TO INVEST IN OUR COMMON STOCK. IF ANY OF THE FOLLOWING RISKS OCCURS, OUR BUSINESS, FINANCIAL CONDITION OR RESULTS OF OPERATIONS COULD BE MATERIALLY ADVERSELY AFFECTED. THE TRADING PRICE OF OUR COMMON STOCK COULD DECLINE DUE TO ANY OF THE FOLLOWING RISKS OR OTHERS NOT YET IDENTIFIED BY MANAGEMENT, AND YOU COULD LOSE ALL OR PART OF YOUR INVESTMENT. RISKS RELATED TO OUR BUSINESS WE HAVE INCURRED SUBSTANTIAL OPERATING LOSSES AND EXPECT TO INCUR FUTURE LOSSES. OUR FUTURE FINANCIAL RESULTS ARE UNCERTAIN, AND WE MAY NEVER BECOME A PROFITABLE COMPANY. From September 16, 2002 (the date that we completed our reorganization proceedings and adopted "fresh-start accounting") through October 31, 2005 we had an accumulated deficit of $5,143,465 Our losses to date are primarily due to the costs of research and development, and the general and administrative costs associated with our operations. We expect to continue to incur operating losses through at least fiscal year 2006. We expect to have quarter-to-quarter and year-to-year fluctuations in revenues and expenses. As a result, our losses may increase in the future, even if we achieve our revenue goals, and some of those losses could be significant. Should we achieve profitability, we may be unable to sustain or increase profitability on a quarterly or annual basis. Many factors could affect our ability to achieve and maintain profitability, including: o our ability to complete successfully the commercialization and production cost optimization of our products; o our ability to manage production costs and yield issues associated with increased production of our products; o the progress of our research and development programs for developing other microalgal products; o the time and costs associated with obtaining regulatory approvals for our products; o our ability to protect our proprietary rights, or the expense of doing so; o the costs of filing, maintaining, protecting and enforcing our patents; o competing technological and market developments; o changes in our pricing policies or the pricing policies of our competitors; o the costs of commercializing and marketing our existing and potential products; and o the inability to achieve a level of sales of our products necessary to generate sufficient revenues to cover research, development and operating costs. 20 If our revenues grow more slowly than we anticipate, or if our operating expenses exceed our expectations and cannot be reduced, our losses could continue beyond our present expectations, and we may never become a profitable company. WE MAY BE UNABLE TO RAISE ADDITIONAL CAPITAL OR GENERATE THE CAPITAL NECESSARY TO SUPPORT OUR PLANNED LEVEL OF RESEARCH AND DEVELOPMENT ACTIVITIES AND TO MANUFACTURE AND MARKET OUR PRODUCTS. We will require expenditures to support our research and development activities and to manufacture and market our products. Over the next twelve months, we project expenditures of approximately $1 million in operating capital, not including any capital expenditures that may be necessary or desirable. Many factors will determine our future capital requirements, including: o market acceptance of our products; o our ability to manufacture our products cost-effectively in quantities needed to sustain growing sales of ASTAFACTOR(R); o the extent and progress of our research and development programs; o the time and costs of obtaining regulatory clearances for some of our products; o the progress and success of pre-clinical and clinical studies, where applicable; o the costs of filing, maintaining, protecting and enforcing patent claims; o the need to address competing technological and market developments; o the cost of developing and/or operating production facilities for our existing and potential products; and o the costs of commercializing our products. Revenue from product sales and other sources pay some of our operating costs, but to date that revenue has not been sufficient to cover our operating costs fully. We are seeking investment from various sources to help sustain our operations until we can increase revenues to the point that they can sustain our operations indefinitely. However, additional financing may not be available on favorable terms, if at all. If we do not have adequate funds, we may have to curtail operations significantly. In addition, we may have to enter into unfavorable agreements that could force us to relinquish certain technology or product rights, including patent and other intellectual property rights. If we cannot raise enough capital, then we may have to curtail production, limit our product development activities, reduce marketing activities or delay other plans intended to increase revenue and help us achieve profitability. IF WE CANNOT OVERCOME THE CHALLENGES OF PRODUCING MICROALGAE ON A COMMERCIAL SCALE, WE MAY NOT ACHIEVE ECONOMIC PRODUCTION COSTS. To be successful, we must produce products at acceptable costs while ensuring that the quantity and quality of our products comply with contractual and regulatory requirements and regulations. Many factors complicate the production of microalgal products, and they could limit production at any time. These include: 21 o microbial contamination; o variability in production cycle times due to technical, environmental and biological factors; and o losses of final product due to inefficient processing. We currently have sufficient inventory to meet the foreseeable requirements of our existing customers. However, we are engaged in efforts to increase sales in order to achieve profitability, potentially beyond the capacity of our existing facility to produce. We have prepared to meet that increased demand, should it occur, by acquiring additional space at our Kona, Hawaii facility. IF THE DEMAND FOR NATURAL ASTAXANTHIN OR OUR OTHER PRODUCTS EXCEEEDS OUR CURRENT PRODUCTION CAPABILITIES, AND IF WE ARE UNABLE TO EXPAND OUR PRODUCTION CAPACITY IN A TIMELY MANNER, WE MAY EXPERIENCE SIGNIFICANT FINANCIAL, TECHNICAL AND COMMERCIAL CHALLENGES. The capacity of our existing production facility in Hawaii is sufficient to meet current demand for our products. However, demand for our natural astaxanthin product may eventually exceed the current capacity of our Hawaiian production facility. To address this capacity question, we have initiated efforts to increase our production efficiency and to prepare for expansion of our Hawaiian facility, if needed. However, our efforts are focused on generating a level of sales that would make it difficult to meet our total demand from our Hawaiian facility, especially if we develop additional products. We believe that our inventory plus our existing production capacity is sufficient to meet demand for the foreseeable future. In the event that sales increase to a level that we cannot meet with our existing capacity, we have planned for the expansion of our Hawaiian facility. If we are unable to expand our current production facility, we may be unable to meet demand for product and could lose the opportunity to increase our revenues. We could also lose customers, both current and potential, who may not do business with us absent an assurance of the ability to deliver product in sufficient quantities. OUR CUSTOMER BASE IS CONCENTRATED AMONG RELATIVELY FEW CUSTOMERS, AND THE LOSS OF ANY OF THESE CUSTOMERS WOULD MATERIALLY ADVERSELY AFFECT OUR REVENUES. Our business currently depends on key distribution relationships in Hawaii. These customers currently purchase approximately 50% of the natural astaxanthin products we sell, with the remainder being sold to smaller retail accounts, directly to consumers or internationally. If we lose one or more of these customers, or if they do not continue buying our products at the current and anticipated purchase levels, then our revenues could decrease. In addition, the loss of one or more of these customers may adversely affect our reputation, and we could have difficulty attracting new customers as a result. IF WE FAIL TO ATTRACT AND RETAIN KEY PERSONNEL WE WILL BE UNABLE TO EXECUTE OUR BUSINESS PLAN, AND OUR BUSINESS WILL SUFFER. Our success depends on the continued efforts of the principal members of our management team. The Company presently has the key members of that team that it needs to retain to execute its plans fully. Success in doing so cannot be assured. OUR BUSINESS WILL NOT OPERATE EFFICIENTLY AND OUR RESULTS OF OPERATIONS WILL BE NEGATIVELY AFFECTED IF WE ARE UNABLE TO MANAGE OUR GROWTH EFFECTIVELY. Until 2002 we focused almost exclusively on product research and technology development. As we moved toward commercial production of microalgal products we had to initiate or expand many activities, including outsourcing, customer relations, engineering, construction, recruiting and training. During this transition, the size of our organization increased rapidly. During the Company's reorganization, the size of our organization decreased again. We experienced a meaningful increase in employment during fiscal 2004 as we resumed production. If revenues do not increase to offset these additional expenses, we may not have the financial resources needed to sustain operations. 22 We expect demands on our financial and management control systems to increase this year. If we fail to upgrade our financial and management control systems, or if we encounter difficulties during upgrades of these systems, then we may not be able to manage our human and financial resources effectively. Such ineffectiveness could make it difficult to retain or attract employees and could directly or indirectly create unnecessary expenses or lead to incorrect decisions by management. AS WE EXPAND OUR PRODUCT LINE AND ATTEMPT TO PENETRATE ADDITIONAL MARKETS, WE MAY FACE SIGNIFICANT CHALLENGES TO SUCCESS. We are exploring expanding our nutraceuticals product line. The success of our nutraceuticals product line will depend on our ability to implement our marketing strategy and comply with the standards of Good Manufacturing Practice, or GMP, as and when applicable. We believe the prospects for nutraceutical astaxanthin will depend, in the short term, on product quality and education of consumers regarding its benefits. Our ability to penetrate new markets for natural astaxanthin products will, we believe, depend strongly on regulatory approval in several major markets outside the United States. We expect the success of our products to depend primarily on our ability to develop and market these new products and, if applicable, to finance clinical trials and obtain regulatory approval for such products. We cannot assure successful development of any potential products, nor can we guarantee market acceptance of any of our products, existing or future. We have limited marketing experience in nutraceutical and pharmaceutical markets. We have less than four years of experience in electronic marketing and direct retail sales. We cannot assure you that we or our consultants or contractors will be successful in our marketing efforts, nor can we prevent them from competing with us or assisting our competitors. If we are unable to develop or commercialize any of our product lines successfully, then our revenues will fail to grow. IF WE DECIDE TO PURSUE RESEARCH AND DEVELOPMENT EFFORTS ON PHARMACEUTICAL PRODUCTS IN ADDITION TO THOSE FOCUSED ON OUR NUTRACEUTICAL PRODUCTS, WE WILL INCUR SIGNIFICANT EXPENSES AND WILL BE EXPOSED TO RISKS ASSOCIATED WITH THE DEVELOPMENT AND COMMERCIALIZATION OF PHARMACEUTICAL PRODUCTS. We are not currently involved in research and development for pharmaceutical candidates, and we do not have any plans to commence those activities during fiscal 2005. However, the Company's management may decide to pursue this line of business in the future, either independently or in collaboration with other parties. If the Company does pursue this line of business, there will be certain risks associated with it. The nature of those risks will depend to a great extent on exactly how the Company chooses to pursue this business. There are many uncertainties, complexities and delays inherent in the research and development, manufacturing, marketing and sale of pharmaceutical products, including: (i) large upfront and continuing capital requirements, (ii) efficacy and safety concerns, (iii) delays in the receipt of or the inability to obtain required approvals, (iv) the suspension or revocation of the authority necessary for manufacture, marketing or sale, (v) the imposition of additional or different regulatory requirements, such as those affecting labeling, (vi) seizure or recall of products, (vii) the failure to obtain, the imposition of limitations on the use of, or the loss of patent and other intellectual property rights and (viii) manufacturing or distribution problems. Pursuing this business in collaboration with another company would help to mitigate those risks. 23 OUR PRODUCTS AND PRODUCTION ACTIVITIES ARE SUBJECT TO GOVERNMENT REGULATION AND ACTION, WHICH ARE SUBJECT TO CHANGE. We are affected by changes in or the imposition of governmental regulations and actions, including: (i) new laws, regulations and judicial decisions related to the production, marketing and sale of pharmaceutical and nutraceutical products, (ii) changes in the United States Food and Drug Administration and foreign regulatory approval processes that may delay or prevent the approval of new products and result in lost market opportunity, (iii) new laws, regulations and judicial decisions affecting pricing or marketing of our products and (iv) changes in the tax laws relating to Mera Pharmaceuticals' operations. WE MAY BE UNABLE TO PROTECT OR ENFORCE OUR INTELLECTUAL PROPERTY RIGHTS ADEQUATELY, AND OUR EFFORTS TO DO SO COULD BE TIME CONSUMING AND EXPENSIVE AND COULD DIVERT MANAGEMENT ATTENTION FROM EXECUTING OUR BUSINESS STRATEGY. We regard the protection of our patents, copyrights, trade secrets and know-how (collectively intellectual property) as critical to our success. We rely on a combination of patent, copyright and trade secret laws and contractual restrictions to protect our intellectual property and maintain our competitive position. Our future prospects depend in part on our ability to protect our intellectual property while operating without infringing the intellectual property rights of third parties. We may be unable to develop any additional patentable technologies. We cannot be certain that any patents issued to us or available to us through a license arrangement will establish the means to produce or provide us with any competitive advantage for any product or products. Third parties could challenge our patents or could obtain patents that have a material adverse effect on our ability to do business efficiently and effectively. The patent positions of nutraceutical, pharmaceutical, biopharmaceutical and biotechnology companies, including ours, are generally uncertain and involve complex legal and factual questions. Patent law continues to evolve in the scope of claims in the technology area in which we operate. Therefore, the degree of future protection for our proprietary rights is uncertain. We cannot guarantee that others will not independently develop similar or alternative technologies. Other parties may duplicate our technologies, or, if patents are issued to us, they may design around those patented technologies. Other parties may have filed or could file patent applications that are similar or identical to some of ours. These patent applications could have priority over ours. To determine the priority of inventions, we may have to participate in interference proceedings declared by the United States Patent and Trademark Office, which could be very costly. In addition, the laws of some foreign countries may not protect our patents and other intellectual property rights to the same extent as the laws of the United States. We could incur substantial costs in litigation if we need to defend ourselves against patent infringement claims brought by third parties, or if we choose to initiate claims against others. We have in the past, and we may in the future, be required to dedicate significant management time and financial resources to prosecute or defend infringement actions. In addition, a finding of non-infringement or declaration of invalidity of our patents could reduce or eliminate the exclusivity of our proprietary technology. Present and potential collaborators may terminate or decide not to enter into relationships with us if our intellectual property position is weakened. In addition, a finding of non-infringement or declaration of invalidity of our patents could reduce our ability to obtain future financing. 24 There could be significant litigation in our industry regarding patent and other intellectual property rights. For example, third parties may bring infringement or other claims against us for using intellectual property that we internally developed or license from third parties. In addition, although nondisclosure agreements generally control the disclosure and use of our proprietary technology, know-how and trade secrets, we cannot guarantee that all confidentiality agreements will be honored or that our proprietary technology, know-how and trade secrets will not be disseminated, or that any party responsible for doing so will be able to compensate us adequately for such loss. We may not prevail in the prosecution or defense of any action, nor can we predict whether third parties will license necessary intellectual property rights to us on commercially acceptable terms, if at all. Any of these outcomes could be very costly and could diminish our ability to develop and commercialize future products. OUR PRODUCTION CAPABILITY IS HIGHLY DEPENDENT ON ENVIRONMENTAL AND CLIMATIC FACTORS BEYOND OUR CONTROL. All of our current production capacity is located at a single facility in Kona, Hawaii. We currently have an ample inventory to meet our foreseeable demand, but any future event that causes a long-term disruption in production at our facility could significantly impair our ability to meet customer demand. These events could include fires, volcanic eruptions, earthquakes, tidal waves, hurricanes or other natural disasters. In addition, consistent sunlight, high ambient temperatures and an ample supply of fresh water are necessary for microalgal growth. If we experience any significant or unusual change in climate, or should our water supplies be threatened by microbial contamination we cannot control, there could be an adverse impact on our production. If we cease production for any significant period, the success of our business would be threatened from a resulting loss of customers, revenues and valuable employees. CURRENCY FLUCTUATIONS AND DIFFERENT STANDARDS, REGULATIONS AND LAWS RELATING TO INTERNATIONAL OPERATIONS MAY ADVERSELY AFFECT OUR RESULTS OF OPERATIONS. We expect to sell our products on a global scale due to projected international market demand. International business is generally more difficult than domestic business and can create additional costs and delays not associated with business conducted solely within the United States. Factors related to doing business internationally that could impact us include: foreign government controls and regulations, economic conditions, currency fluctuations, duties and taxes, political and economic instability or unrest, imposition of or increases in tariffs, disruptions or delays in shipments and other trade restrictions. These factors, among others, can all lead to interference with or increased costs of operation and the ability to sell products in international markets. If any such factors were to render the conduct of business in a particular country undesirable or impracticable, there could be a material adverse effect on our business, our financial condition and the results of operations. There can be no assurance that our products or marketing efforts will be successful in foreign markets. In addition, fluctuations in currency exchange rates could make our products more expensive in some countries, resulting in the loss of customers in those markets. WE MAY BE SUBJECT TO PRODUCT LIABILITY LAWSUITS, AND OUR INSURANCE MAY BE INADEQUATE TO COVER DAMAGES. Clinical trials or marketing of any of our current or potential products may expose us to liability claims arising from the use of these products. Even the most thorough of clinical trials could fail to detect a significant side effect associated with long-term use of a product, and it is possible that liabilities will arise even after our products receive any required regulatory approvals. Even if such claims are not well-founded, defending them will be very costly and consume substantial management attention and energy. We cannot ensure that our current product liability insurance, together with indemnification rights under our existing or future licenses and collaborative arrangements, will be adequate to protect us against any claims and resulting liabilities. As we expand our business, we may be unable to obtain additional insurance on commercially reasonable terms. We could suffer harm to our financial condition and our reputation if a product liability claim or recall exceeds the limits of our insurance coverage. 25 BECAUSE OUR PRINCIPAL STOCKHOLDERS HAVE SIGNIFICANT CONTROL OF OUR MANAGEMENT AND AFFAIRS, THESE STOCKHOLDERS MAY BE ABLE TO CONTROL US AND ALSO PREVENT POTENTIALLY BENEFICIAL ACQUISITIONS OF OUR COMPANY BY OTHERS. As of October 31, 2005, our current directors and executive officers, as a group, beneficially owned approximately 20% of the approximately 467,637,161 shares of our common stock outstanding as of October 31, 2005. As a result, our officers and directors may be able to exert considerable influence over the actions of the Board of Directors and matters requiring approval of our stockholders. This concentration of ownership could delay or prevent a change in control and may adversely affect the ability of other stockholders to adopt a position in opposition to these directors and officers. Our principal stockholders may have interests that differ from our other stockholders, particularly in the context of potentially beneficial acquisitions of our Company by others, and they may legitimately vote as stockholders in a manner that protects their interests. RISKS RELATED TO OUR INDUSTRY IF WE FAIL TO COMPETE EFFECTIVELY AGAINST LARGER, MORE ESTABLISHED COMPANIES WITH GREATER RESOURCES, OUR BUSINESS WOULD SUFFER. Competition in the nutraceutical and pharmaceutical markets is intense. Factors affecting competition include financial resources, research and development capabilities and manufacturing and marketing experience and resources. Our nutraceutical astaxanthin product will compete directly with the products of several companies that sell a similar nutraceutical product. Three of these companies have a product that, like ours, is based on astaxanthin derived from HAEMATOCOCCUS PLUVIALIS. MicroGaia, Inc., Cyanotech and AlgaTechnologies also sell competing nutraceutical astaxanthin products, as do parties that purchase products from them. We expect that our nutraceutical astaxanthin product will compete on the basis of product quality, price, efficiencies derived from our intellectual property and an effective marketing strategy. However, if our competitors develop a proprietary position that inhibits our ability to compete, or if our marketing strategy is not successful, then our revenues may not increase. There are various companies using microalgae cultivation technology processes that compete with our processes. We are aware of two U.S. companies, Martek of Maryland and Omega-Tech of Colorado, that produce commercial quantities of microalgae using modified fermentation processes. We are also aware of one company, Cell Tech of Oregon, which harvests microalgae from natural environmental sources. There are three other companies in the world - Biotechna of Australia, AlgaTechnologies of Israel and MicroGaia of Hawaii - that claim to possess proprietary photobioreactor technology and use it for commercial purposes. While there are many other photobioreactors in operation besides those, to our knowledge, they are all operated by universities or research institutes and are not used for commercial purposes. It is possible that competing photobioreactor technologies that could adversely affect our perceived technical and competitive advantages already exist or may emerge in the future. 26 We also anticipate that the competition to develop microalgal-based products other than natural astaxanthin will increase. We expect competitors to include major pharmaceutical, food processing, chemical and specialized biotechnology companies. Many of these companies will have financial, technical and marketing resources significantly greater than ours. There are also other emerging marine biotechnology companies that could form collaborations with large established companies to support research, development and commercialization of products that may compete with our current and future products. Also, academic institutions, governmental agencies and other public and private research organizations are conducting research activities and seeking patent protection for microalgal products and may commercialize products that compete with ours on their own or through joint ventures. In addition, there may be technologies we are unaware of, or technologies that may be developed in the future, that could adversely affect our perceived technical and competitive advantage. INCREASED COMPETITION MAY SIGNIFICANTLY REDUCE THE MARKET PRICE OF NATURAL ASTAXANTHIN. Astaxanthin can be produced either naturally from Haematococcus pluvialis, as we do, from a yeast by fermentation, as Igene Biotechnology, Inc. does, or through synthesis of chemical compounds. We are not aware that synthetic astaxanthin is approved for direct human consumption in any jurisdiction, although the FDA approved the Hoffman-LaRoche, Ltd. synthetic astaxanthin product as a food additive in fish feed in 1995. The Igene yeast-based product is also not approved for regular human consumption. We believe that the cost of producing synthetic astaxanthin is significantly lower than that for natural astaxanthin. We are not able to determine how production costs for the yeast-based product compares with ours. If we succeed in commercializing natural astaxanthin to the extent we project, producers of yeast-based and synthetic astaxanthin may increase their efforts to obtain approval of their product for human consumption. Studies have shown that natural astaxanthin is more effective than synthetic astaxanthin when used with various fish and shellfish populations. However, we have not determined that to be the case in human applications. The introduction of yeast-based or synthetic astaxanthin into the human nutraceutical marketplace could adversely affect the price at which we sell our product and the market share that we can obtain. While we believe that there are substantial hurdles to the approval of yeast-based and synthetic astaxanthin for human consumption in the U.S. and other major markets, we cannot be certain that such approval will not occur. A single producer, Hoffman-LaRoche, Inc., currently dominates the synthetic astaxanthin market. Hoffman-LaRoche has maintained the market price of its synthetic astaxanthin, which is derived from petrochemicals, at approximately $1,800 - $2,500 per kilogram. That is below the price at which we would be able to sell astaxanthin in comparable form. IF WE ARE UNABLE TO COMPLY WITH GOVERNMENT REGULATION OF OUR PRODUCTS AND PRODUCTION ACTIVITIES, WE MAY BE FORCED TO DISCONTINUE PRODUCTION OF CURRENT OR FUTURE PRODUCTS. We are subject to federal, state, local and foreign laws and regulations governing our products and production activities. This makes us vulnerable to: (i) the imposition of new laws, regulations and judicial decisions related to pharmaceutical and nutraceutical products, (ii) changes in the United States Food and Drug Administration and foreign regulatory approval processes that may delay or prevent the approval of new products and result in lost market opportunity, (iii) delays in the receipt of or the inability to obtain required approvals, (iv) new laws, regulations and judicial decisions affecting pricing or marketing of pharmaceutical and nutraceutical products, (v) the suspension or revocation of the authority necessary for manufacture, marketing or sale of our products, (vi) the imposition of additional or different regulatory requirements, such as those affecting labeling, (vii) seizure or recall of products, and (viii) the failure to obtain, the imposition of limitations on the use of, or the loss of patent and other intellectual property rights. While we do not consider our products to be "herbal" supplements (i.e., products that are made from drying and grinding entire plant parts), increased regulatory scrutiny of herbal products as the result of health issues (e.g., with ephedra) may also lead to more stringent regulation of our products. 27 Each existing or potential product that we develop, produce, market or license presents unique regulatory problems and risks. Relevant regulations depend on product type, use and method of manufacture. The FDA regulates, in varying degrees and in different ways, dietary supplements, other food products, medical devices and pharmaceutical products. Regulations govern manufacture, testing, exportation and labeling, while the Federal Trade Commission (FTC) regulates advertising. We are or may become subject to other federal, state and foreign laws, regulations and policies with respect to labeling of products, importation of organisms and occupational safety, among others. Federal, state and foreign laws, regulations and policies are always subject to change and depend heavily on administrative policies and interpretations. We cannot ensure that any of our products will satisfy applicable regulatory requirements. Changes could occur in federal, state and foreign laws, regulations and policies and, particularly with respect to the FDA or other such regulatory bodies, such changes could be retroactive. Such changes could have a material adverse effect on our business, financial condition, results of operations and relationships with corporate partners. Nutraceutical products that we develop will be viewed as human dietary supplements. The FDA requires pre-market clearance in the United States, as do other countries where these nutraceutical products are marketed, if they are intended for human consumption. The process of obtaining FDA clearance for either a food additive or a human dietary supplement can be expensive and time consuming, although significantly less expensive than the process for obtaining clearances for a new pharmaceutical. With natural products such as ours there is often only a brief and inexpensive waiting period before marketing of a nutraceutical can begin. Extensive information is required on the toxicity of the additive, including carcinogenicity studies and other animal testing. FDA clearance to market dietary supplements is obtained by notifying the FDA in writing of the intention to market a certain product and providing supporting documentation regarding toxicity. If the FDA does not object within a specified period of time, approval is deemed granted. Mera's corporate predecessor received FDA clearance for the ASTAFACTOR(R) in early 2000. We similarly notified the FDA of our intention to market SalmonEssentials in 2004, without objection. While we believe that the natural products on which we are focused will be subject to few objections in this approval process, we cannot ensure that any of our future products, on which we may have expended substantial development effort, will be cleared by the FDA on a timely basis, if at all. The ASTAFACTOR(R) AND SALMONESSENTIALS(TM), our nutraceutical astaxanthin products, are being distributed internationally already and are likely to be distributed in others. Regulatory approvals in foreign markets vary by country. We believe the approval process for these products will generally come under their "natural product" status and be approved relatively quickly. However, we can provide no assurances in this regard. THE PRICE OF OUR COMMON STOCK MAY BE HIGHLY VOLATILE. The trading price of our common stock has been, and is likely to continue to be, highly volatile. We could be subject to wide fluctuations in price in response to various factors, many of which are beyond our control, including: 28 o announcements of technological innovations or new commercial products by us or our competitors; o developments concerning proprietary rights, including patents, by us or our competitors; o publicity regarding actual or potential benefits or drawbacks relating to products under development by us or our competitors; o conditions or trends in the life sciences, nutraceutical or pharmaceutical markets; o changes in the market valuations of biotechnology and life sciences companies in general; and o general regulatory developments affecting our products in both the United States and foreign countries. In addition, technology companies have experienced extreme price and volume fluctuations that have often been unrelated or disproportionate to the operating performance of those companies. There has been particular volatility in the market prices of securities of life science companies. These broad market and industry factors may seriously harm the market price of our common stock, regardless of our operating performance. RISKS RELATED TO THE SECURITIES MARKETS AND OUR COMMON STOCK OUR COMMON STOCK IS TRADED IN THE OVER-THE-COUNTER MARKET, WHICH MAY MAKE THE STOCK MORE DIFFICULT TO TRADE ON THE OPEN MARKET. Our common stock is currently traded in the over-the-counter market on the NASD Electronic Bulletin Board. Securities on the NASD Electronic Bulletin Board are generally more difficult to trade than those on the Nasdaq National Market, the Nasdaq SmallCap Market or the major stock exchanges. Since the initial public offering of our common stock in January 1989, the average daily trading volume of our common stock has been relatively low. We cannot ensure that a more active public trading market will ever develop for our common stock. In addition, accurate price quotations can be difficult to obtain and price volatility is common for companies whose securities trade on the NASD Electronic Bulletin Board. THE SALE OF A SUBSTANTIAL NUMBER OF SHARES OF OUR COMMON STOCK BY STOCKHOLDERS COULD CAUSE THE MARKET PRICE OF OUR COMMON STOCK TO DECLINE. As of January 27, 2006 we had 479,175,623 shares of common stock outstanding. Of these shares, approximately 350,000,000 have either been registered under the Securities Act of 1933, as amended (the "Securities Act"), are freely tradable without volume limitations under Rule 144 of the Securities Act or are exempt from registration under 11 U.S.C. 1145 as a result of the reorganization of our predecessor issuer, Aquasearch, Inc. We cannot predict the effect, if any, that sales of shares of our common stock or the availability of these shares being offered for sale will have on prevailing market prices. However, if substantial amounts of our common stock were sold in the public market, then market prices for our common stock could decrease so much that we may not be able to raise additional capital through the sale of equity securities. We may need additional funding for capital expenditures and operating capital. If we raise additional funds by selling equity securities, the share ownership of our existing investors could be diluted. In addition, new equity purchasers may obtain rights, preferences or privileges that are superior to those of our existing stockholders. 29 THE ABILITY OF OUR BOARD OF DIRECTORS TO ISSUE PREFERRED STOCK COULD ADVERSELY AFFECT THE INTERESTS OF OUR STOCKHOLDERS. Our Certificate of Incorporation authorizes the issuance of up to 10,000 shares of "blank check" preferred stock, of which only slightly more than 1,000 have been issued to date. Our Board of Directors has the power to determine all designations, rights, preferences, privileges and restrictions of this preferred stock. In addition, our Board of Directors is not required to obtain stockholder approval to issue preferred stock with dividend, liquidation, conversion, voting or other rights that could adversely affect the voting power or other rights of the holders of our common stock. The Board of Directors could issue the preferred stock in order to raise needed capital, or to discourage, delay or prevent a change in control of our Company, even if a change of control would be beneficial to our stockholders. ITEM 7. FINANCIAL STATEMENTS Audited balance sheet as of October 31, 2005 and the related statements of operations, cash flows and stockholders' equity (deficit) for the years ended October 31, 2005 and 2004, together with related notes and the report of Jewett, Schwartz & Associates, our independent auditors, appear on pages F-1 through F-18 of this Report. ITEM 8. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE There were no disagreements with accountants on accounting and financial disclosure during fiscal 2005 or 2004. ITEM 8A. CONTROLS AND PROCEDURES. Items 307 and 308 of Regulation S-B. Evaluation of Disclosure Controls and Procedures. Our Chief Executive Officer and Chief Financial Officer have evaluated the effectiveness of our disclosure controls and procedures (as such term is defined in Rules 13a-15 (e) and 15d-15(e) under the Securities Exchange Act of 1934, as amended (the "Exchange Act")) as of the end of the period covered by this report. Based on such evaluation, such officers have concluded that, as of such date, our disclosure controls and procedures are effective in alerting them on a timely basis to material information relating to Mera Pharmaceuticals required to be included in our reports filed or submitted under the Exchange Act. Changes in Internal Control over Financial Reporting. There were no significant changes in our internal control over financial reporting that have materially affected or are reasonably likely to materially affect, our internal control over financial reporting. ITEM 8B. OTHER INFORMATION. None. PART III ITEM 9. DIRECTORS, EXECUTIVE OFFICERS AND CONTROL PERSONS; COMPLIANCE WITH SECTION 16(a) OF THE EXCHANGE ACT DIRECTORS AND EXECUTIVE OFFICERS The following table sets forth certain information regarding our current directors and executive officers. 30 NAME AGE POSITION - -------------------------------------------------------------------------------- Daniel P. Beharry......... 53 Chief Executive Officer (1), Secretary and Director Kenneth Crowder........... 67 Director Gregory F. Kowal ......... 57 Director (2) Laurence Sombardier 37 Vice-President and General Manager of the Operations and Production Facility Miguel Olaizola, PhD ..... 43 Research Manager (1) As of January 3, 2006, Mr. Beharry relinquished responsibilities as chief executive officer and assumed the role of president of the Company's Research and Development Division. He retained his responsibilities as secretary and director. (2) As of January 3, 2006, Mr. Kowal assumed the role of the Company's chief executive officer in addition to his role as chairman of the board of directors. GREGORY F. KOWAL, CHIEF EXECUTIVE OFFICER AND DIRECTOR, has served as a director of our Company since June 2002. He assumed the role of CEO on January 3, 2006. Mr. Kowal is co-founder of First Honolulu Securities, Inc. and has been continuously associated with it since 1979. He currently is Chairman of the Board and Portfolio Manager of First Honolulu Asset management and is on the financial advisory board of Concordia Financial, a California truck leasing servicing firm. He was also President of Hawaii Tsunami Pro Soccer Incorporated. Prior to founding First Honolulu, he was associated with a large west coast regional brokerage firm from 1973 until 1979. Mr. Kowal received his BSBA from Roosevelt University (Chicago, IL) in 1972. His area of concentration at Roosevelt included management and finance. DANIEL BEHARRY, SECRETARY AND DIRECTOR, has served as a director of our company since June 2002. He stepped down as Chief Executive Officer on January 3, 2006, having served in that position since July 2003. He continues as the Company's secretary and as President of our Research and Development Division. He received his undergraduate degree from Yale College and his law degree from the University of Southern California. After 17 years in private legal practice, Mr. Beharry joined the legal and management staff of Caradon Inc. (now Novar, Inc.), the North American corporate headquarters of Caradon (now Novar) plc, a $3 billion per year British industrial and building materials conglomerate. His responsibilities at Caradon included implementation of a quality improvement process in more than 30 North American operations. Mr. Beharry began working on development stage companies in 1997, and he participated in the founding of medibuy, Inc. in 1998, and numerous other businesses. 31 KENNETH CROWDER, DIRECTOR, has served as a director of the Company since September 16, 2003. Mr. Crowder is the founder and Chief Executive officer of Concordia Finance, which participates in the financing of big rig (Class 8) trucks. Prior to that, he spent more than two decades as an engineer for Northrup corporation, working on a number of products. He began his engineering career with the U.S. Naval Ordnance Lab in Corona, California. Mr. Crowder received a BA in physics from University of California Riverside in 1960 and a Masters in physics from California State University at Long Beach in 1966. LAURENCE SOMBARDIER, VICE PRESIDENT AND GENERAL MANAGER OF THE OPERATIONS AND PRODUCTION FACILITY, has served as Vice President and General Manager of the Company's Operations and Production Facility in Hawaii since October 2002. Mrs. Sombardier joined the Company in October 1997. She was instrumental in expanding the initial pilot plant to a production facility as well as setting up the process control system for the patented Mera Growth Module. Mrs. Sombardier has also led all Information Technology-related efforts for the Company since 1997. She received a MS in Physical Oceanography from Scripps Institution of Oceanography. After receiving her degree, she managed the Global Drifter Center, a world wide scientific effort out of Scripps Institution of Oceanography to measure the world's ocean surface currents. DR. MIGUEL OLAIZOLA received his Ph.D. in Biological Oceanography from the State University of New York at Stony Brook in 1993. Dr. Olaizola has led research in pigment biosynthesis, microalgal physiology and productivity since joining Aquasearch in 1996. He also administers our internship program and manages our quality control laboratory. Dr. Olaizola devoted his graduate and post-graduate research to the study of carotenoid biosynthesis in microalgae, primarily diatoms and cyanobacteria, the latter being a principal area of focus for Mera. During 1993 to 1995, Dr. Olaizola was a Post-Doctoral Fellow at the Joint Research Center of the European Commission in Italy. During 1995 and 1996, Dr. Olaizola was a Post-Doctoral Researcher at Scripps Institution of Oceanography, University of California, San Diego, where he studied microalgal growth and physiology. He was recently appointed as an Affiliate Professor of Aquaculture at the University of Hawaii at Hilo and Adjunct Associate Researcher at the University of Hawaii at Manoa. ITEM 10. EXECUTIVE COMPENSATION SUMMARY COMPENSATION The following table sets forth the information, on an accrual basis, with respect to the compensation of our executive officers for the three fiscal years ended October 31, 2004. YEAR ENDED RESTRICTED STOCK NAME AND PRINCIPAL POSITION OCTOBER 31, SALARY ($) AWARD(S) ($) - --------------------------- ----------- ---------- ------------ Daniel P. Beharry, Chief 2005 $ 78,750 $ 0 Executive Officer 2004 $118,450 $ 0 2003 $115,250(1) $ 0 (1) Mr. Beharry assumed the role of Chief Executive Officer effective July 16, 2003. The compensation stated for 2003 includes that paid to him in his role as Chief Operating Officer prior to July 16, 2003. The compensation stated for 2002 reflects his salary for the period August 1, 2002 through October 31, 2002 in his capacity as Chief Operating Officer, during which time his annual salary rate was $150,000. 32 OPTION GRANTS IN FISCAL 2005 The following options were granted to our executive officers during fiscal 2005: OPTIONS/SAR GRANTS IN LAST FISCAL YEAR Individual Grants
(a) (b) (c) (d) (e) % of Total Options/SARs Exercise or Number of Securities Underlying Granted to Employees Base Price Name Options/SARs Granted (#) in Fiscal Year ($ per share) Expiration Date Daniel P. Beharry, CEO 17,010,000 35.10% $0.01 November 7, 2014
STOCK OPTIONS EXERCISED DURING FISCAL 2005 No stock options were exercised by the named executive officers of the Company during fiscal 2005. FISCAL YEAR-END OPTION VALUES The total value of Mr. Beharry's unexercised vested options as of October 31, 2005, was $78,671.25. LTIP AWARDS DURING FISCAL YEAR We did not make any long-term incentive plan awards to any executive officers or directors during the fiscal year ended October 31, 2005. DIRECTOR COMPENSATION Our directors do not receive compensation for services they provide as directors, although they are reimbursed their expenses for attendance at board meetings and those otherwise incurred in connection with their duties. We do not provide additional compensation for committee participation or special assignments of the Board of Directors. Our outside directors, Messrs. Kowal and Crowder, were each granted options on December 2004 to purchase 5,000,000 shares of the Company's common stock in respect of their service as board members. The exercise price of those options was $0.01 per share. None of the options has been exercised. 33 EMPLOYMENT CONTRACTS We currently do not have employment contracts with our named executive officers. ITEM 11. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT The following table provides information known to us about the beneficial ownership of our common stock as of January 27, 2006 for: (1) each person, entity or group that is known by us to beneficially own five percent or more of our common stock; (2) each of our directors (and former directors, as applicable); (3) each of our named executive officers (and former officers, as applicable) as defined in Item 402(a)(2) of Regulation S-B; and (4) our directors and executive officers as a group. To the best of our knowledge, each stockholder identified below has voting and investment power with respect to all shares of common stock shown, unless community property laws or footnotes to this table are applicable.
PERCENTAGE OF NATURE OF SHARES BENEFICIAL NUMBER OF SHARES BENEFICIALLY DIRECTORS AND OFFICERS (1) OWNERSHIP BENEFICIALLY OWNED OWNED (1) - -------------------------- --------- ------------------ --------- Kenneth Crowder c/o Mera Pharmaceuticals, Inc. 73-4460 Queen Ka'ahumanu Highway, Suite 110 Kailua-Kona, Hawaii 96740....................... Direct 6,302,379(2) 1.35% Daniel P. Beharry c/o Mera Pharmaceuticals, Inc. 73-4460 Queen Ka'ahumanu Highway, Suite 110 Direct and Kailua-Kona, HI 96740 .......................... Indirect 48,751,843(3) 10.43% Gregory F. Kowal First Honolulu Securities 900 Fort Street Mall, Suite 90 Direct and Honolulu, Hawaii 96813......................... Indirect 40,067,541(4) 8.57% All directors and executive officers as a group Direct and (4 persons) ................................. Indirect 20.34% 5% STOCKHOLDERS - --------------- Richard D. Propper, MD 625 Broadway, Suite 1111 Direct and San Diego, CA 92101 ........................... Indirect 33,943,623 7.26%
(1) Applicable percentage of beneficial ownership is based on shares outstanding as of January 27, 2006. Beneficial ownership is determined in accordance with rules and regulations of the Securities and Exchange Commission. In computing the number of shares beneficially owned by a person and the percentage ownership of that person, shares of common stock subject to options or warrants held by that person that are currently exercisable or exercisable within 60 days the date of this report are deemed outstanding, but are not deemed outstanding for computing the percentage of any other person. 34 (2) This amount includes 3,125,000 shares that Mr. Crowder has the right to acquire within sixty days from the date of this report on Form 10-KSB by exercising stock options. (3) This amount includes 13,381,121 shares held by Mr. Beharry's spouse (directly or indirectly), plus 170,000 shares that Mr. Beharry has the right to acquire by exercising common stock warrants that he holds and 14,883,750 shares that Mr. Beharry has the right to acquire by exercising stock options within sixty days from the date of this report on Form 10-KSB. (4) These shares held indirectly are in the name of Aquasearch Investment Partners, of which Mr. Kowal is a general partner. This figure also includes warrants to acquire 1,660,000 shares of common stock which were issued to Aquasearch Investment Partners and Gregory F. Kowal and 4,375,000 shares that Mr. Kowal has the right to acquire within sixty days of this report on Form 10-KSB by exercising stock options. ITEM 12. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS On December 27, 2003, the Company issued 16,909,091 shares of common stock at $0.11 per share, for an aggregate purchase price of $1,860,000 to a Delaware limited liability company. A person who is a shareholder, officer and director of the Company manages that limited liability company in part but does not have an ownership interest in that limited liability company. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). During the month of October 2004 the Company issued a promissory note in the amount of $20,000 to an individual who was at the time, and continues to be, a director of the Company. In December 2002 the Company issued 18,181,818 shares of common stock at a price of $0.11 per share, for aggregate consideration of $2,000,000, to a Hawaiian limited liability company. Certain parties who at the time were officers and directors of the Company, one of whom continues to be, manage that limited liability company in part, but do not have an ownership interest in it. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In December 2002 the Company issued 974 shares of Series B preferred stock at a price of $625.00 per share, for aggregate consideration of $609,000, to a limited liability company. That company is managed in part by certain parties who at the time were officers and directors of the Company, one of whom continues to be. Each share of Series B preferred stock is convertible into 8,929 shares of common stock. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In March 2003 the Company entered into an agreement with a partnership of which a director of the Company is a general partner. Under the terms of the agreement the Company sold certain inventory for $76,000 to the partnership and has the right to resell the inventory, and upon doing so is obligated to repay the partnership the price it paid for the inventory plus 10%. Revenue from the sale of the inventory to the partnership is deferred until such time as the Company resells the inventory. The Company satisfied the $26,143.70 remaining due on this obligation by the issuance of equity in March 2005. In April 2003 the Company entered into a line of credit agreement with a partnership of which a director of the Company is a general partner. The line of credit was established to fund operations, and the Company was permitted to borrow up to $125,000 at an annual interest rate of 10%. Under the terms of the agreement the outstanding principal and interest is convertible into common stock. Additionally, the lender received detachable stock purchase warrants, as defined, at price of $0.05 per common share in consideration for the extension of credit under this arrangement. The principal balance on this line of credit was repaid in full during fiscal year 2004 35 In May 2003 the Company's board of directors agreed to compensate one of its members for his successful efforts in assisting the Company in raising capital during fiscal 2003. The compensation is in the form of issuance of common stock of the Company equal to 7% of the total amount raised in each offering divided by the per share price of such offering. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In July 2003 the Company issued 6,428,571 shares of common stock at a price of $0.035 per share, to a Delaware limited liability company. That company is managed in part by a person who is a shareholder and an officer and director of the Company. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In July 2003 a promissory was issued to a limited liability company managed by a person who is a shareholder and an officer and director of the Company. The note accrued interest at an annual rate of 6% and was due and payable on December 31, 2003. The balance outstanding was $644,000 as of October 31, 2003 and the note was paid in full subsequent to year-end. In December 2003 the Company issued 18,181,818 shares of common stock at a price of $0.11 per share to a Delaware limited liability company. That company is managed in part by persons who, at the time of the investment, were shareholders, officers and directors of the Company, and one of them continues to be. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In October 2004 the Company issued a note for $20,000 to a director who loaned the Company that amount. The terms of the note included interest payable at the rate of 6% and a maturity date of December 31, 2004. That loan has since been repaid in full. As a part of the compensation payable by the Company to the lender, the Company issued warrants to purchase 100,000 shares of the Company's common stock. The warrants have an exercise price of $0.02 per share and a term of five years. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In November 2004 the Company issued a promissory note to a director of the Company, in consideration for a loan of $17,000 to the Company. As part of the compensation for the loan, the Company issued to the lender detachable warrants to purchase 85,000 shares of the Company's common stock at a price of $0.02 per share, which warrants have a term of five years. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In November 2004 the Company issued a promissory note to a director of the Company, in consideration for a loan of $10,000 to the Company. As part of the compensation for the loan, the Company issued to the lender detachable warrants to purchase 50,000 shares of the Company's common stock at a price of $0.02 per share, which warrants have a term of five years. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In March 2005 the Company issued 2,614,370 shares of its common stock to Aquasearch Investment Partners, a general partnership, in exchange for cancellation of a debt in the amount of $26,143.70 owed to it under a factoring agreement previously entered into, or an effective price of $0.01 per share. Gregory F. Kowal, the chairman of the Company's board of directors, is a general partner of Aquasearch Investment Partners. This issuance was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). 36 In March 2005 the Company issued 87,298, 1,354,028 and 1,582,771 to Gregory F. Kowal, Daniel P. Beharry and Kenneth Crowder, respectively, in exchange for their forgiveness of debts in the amount of $872.98, $13,540.28 and $15,827.71 owed to them by the Company for expenses incurred by them on the Company's behalf. The effective per share price of these issuances was $0.01 per share. Messrs. Kowal, Beharry and Crowder are all members of Mera's board of directors. These issuances were exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In March and April 2005 the Company issued 6,810,770 shares to a director in exchange for total investment of $68,107.70, a per share price of $0.01. This issuance was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In September and October 2005, the Company issued promissory notes to a director of the Company in the amount of $10,000 in exchange for loans totaling that amount made by the director to the Company for use as working capital. In September and October 2005, the Company issued promissory notes to a director of the Company in the amount of $25,400 in exchange for oans totaling that amount made by the director to the Company for use as working capital. ITEM 13. EXHIBITS AND REPORTS ON FORM 8-K INDEX OF EXHIBITS 2.1* Plan Confirmation Hearing and Debtor's Plan of Reorganization 2.2** Certificate of Merger Merging Aquasearch, Inc., a Colorado Corporation, into Mera Pharmaceuticals, Inc., a Delaware Corporation 2.3** Certificate of Merger Merging Aqua RM Co, Inc. into Mera Pharmaceuticals, Inc. 3.1** Certificate of Incorporation 3.2### Certificate of Designation of Series A Preferred Stock of Mera Pharmaceuticals, Inc. and the Express Terms Thereof. 3.3### Certificate of Designation of Series B Preferred Stock of Mera Pharmaceuticals, Inc. and the Express Terms Thereof 3.4** Bylaws 4.1+ Form of 1996 Bridge Loan Note 4.2+ Form of 1997 Warrant 4.3++ Form of Convertible Note 4.4++ Form of Warrant 4.5++ Form of Note and Warrant Purchase Agreement 4.6# Form of Promissory Note 10.1# Distribution and Development Agreement between Cultor Ltd. and Aquasearch, dated May 14, 1996 (terminated) 10.2# Stock Subscription Agreement between Cultor Ltd. and Aquasearch, dated May 14, 1996 37 10.3+ The Amended Keahole Point Facilities Use Agreement dated August 22, 1996 by and between The National Energy Laboratory of Hawaii Authority and Aquasearch, Inc. 10.4$ Letter of Intent between C. Brewer and Company Limited and Aquasearch, Inc. 10.5## Amendment to Distribution and Development Agreement between Cultor Ltd. and Aquasearch, Inc., dated June 14, 1999 10.6$$ Common Stock Purchase Agreement (including Form of Warrant) between Alpha Venture Capital, Inc. and Aquasearch, Inc., dated June 14, 2000 10.7$$ Registration Rights Agreement between Alpha Venture Capital, Inc. and Aquasearch, Inc., dated June 14, 2000 10.8### Sublease between the Company and Ancile Pharmaceuticals, Inc., dated July 31, 2002. 10.9$$$ Technical Services Contract, dated November 9, 2002, between the Company and Hainan Sunshine Marine Bioengineering Co., Ltd. 16.1*** Letter Regarding Change in Certifying Accountant. Ernst & Young Letter, dated January 24, 2002 16.2*** Letter Regarding Change in Certifying Accountant. Company Letter, dated January 16, 2002 16.3**** Letter Regarding Change in Certifying Accountant. Buttke, Bersch & Wanzek letter dated September 9, 2003 16.4***** Letter Regarding Change in Certifying Accountant. Buttke, Bersch & Wanzek letter dated October 29, 2003 23.1### Consent of Buttke, Bersch & Wanzek, P.C., independent auditors 23.2 Consent of Buttke, Bersch & Wanzek, P.C., independent auditors 31.1 Certification of the Chief Executive Officer pursuant to Rule 13a - 14 (a) of the Securities Exchange Act of 1934 31.2 Certification of the Principal Accounting Officer pursuant to Rule 13a - 14 (a) of the Securities Exchange Act of 1934 32.1 Certification of the Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted to Section 906 of the Sarbanes-Oxley Act of 2002 32.2 Certification of the Principal Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted to Section 906 of the Sarbanes-Oxley Act of 2002 * Incorporated by reference to the exhibit filed with our Current Report on Form 8-K, dated July 3, 2002 ** Incorporated by reference to the exhibits filed to the exhibits of our Current Report on Form 8-K, dated July 30, 2002. *** Incorporated by reference to the exhibit filed with out Current Report on Form 8-K, dated January 24, 2002 **** Incorporated by reference to the exhibit filed with our Current Report on Form 8-K dated September 5, 2003. ***** Incorporated by reference to the exhibit filed with the amendment to our Current Report on Form 8-K A filed on November 13. 2003. + Incorporated by reference to the exhibit filed with our Annual Report on Form 10-KSB for the fiscal year ended October 31, 1996 ++ Incorporated by reference to the exhibit filed with Amendment No. 1 to our Registration Statement on Form S-B filed October 28, 1998 +++ Previously filed # Incorporated by reference to the exhibit filed with our Current Report on Form 8-K filed September 13, 1996 38 ## Incorporated by reference to the exhibit filed with Amendment No. 1 to the Company's Registration Statement on Form SB-2 filed November 9, 1999 $ Incorporated by reference to the exhibit filed with our Current Report on Form 8-K, dated November 13, 1996 $$ Incorporated by reference to the exhibit filed with our Registration Statement on Form SB-2 filed July 13, 2000 $$$ Incorporated by reference to the exhibit filed with our Report on Form 10-QSB filed March 24, 2003 ### Incorporated by reference to the exhibit filed with our registration statement filed on Form SB-2/A dated December 11, 2003. EXHIBITS 31.1 Certification of Chief Executive Officer pursuant to Rule 13a - 14 (a) of the Securities Exchange Act of 1934 (filed herewith electronically). 31.2 Certification of Principal Financial and Accounting Officer pursuant to Rule 13a - 14 (a) of the Securities Exchange Act of 1934 (filed herewith electronically). 32.1 Certification of Chief Executive Officer pursuant to 18 U.S.C. Section 1350, as adopted to Section 906 of the Sarbanes-Oxley Act of 2002 (filed herewith electronically). 32.2 Certification of Principal Financial and Accounting Officer pursuant to 18 U.S.C. Section 1350, as adopted pursuant to Section 906 of the Sarbanes - Oxley Act of 2002 (filed herewith electronically) REPORTS ON FORM 8-K The Company filed a report on Form 8-K on January 6, 2006 describing a change in the organization of the Company and the appointment of Gregory F. Kowal as Chief Executive Officer and the appointment of Daniel P. Beharry as President of the Research and Development Division of the Company. SIGNATURES In accordance with the requirements of the Securities Act, the registrant certifies that it has reasonable grounds to believe that it meets all the requirements of filing on Form 10--KSB and authorized this Form 10-KSB to be signed on its behalf by the undersigned, in the City of Honolulu, State of Hawaii, on February 13, 2006. MERA PHARMACEUTICALS, INC. /s/ Gregory F. Kowal -------------------------------- Gregory F. Kowal Chief Executive Officer 39 In accordance with the requirements of the Securities Act, this Registration Statement on Form 10-KSB was signed by the following persons in the capacities and on the dates stated: SIGNATURE TITLE DATE /s/ Gregory F. Kowal Chief Executive Officer, February 13, 2006 - ----------------------- and Director /s/ Anthony Applebaum Principal Financial and February 13, 2006 - ----------------------- Accounting Officer Anthony Applebaum Kenneth Crowder Director February 13, 2006 Daniel P. Beharry Secretary and Director February 13, 2006 40 FINANCIAL STATEMENTS Mera Pharmaceuticals, Inc. Table of Contents Report of Registered Public Accounting Firm........................ F-2 Balance Sheet...................................................... F-3 Statements of Operations........................................... F-4 Statements of Changes in Stockholders' Equity...................... F-5 Statements of Cash Flows .......................................... F-6 Notes to Financial Statements...................................... F-7-14 F-1 REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM To the Board of Directors and Shareholders of Mera Pharmaceuticals, Inc. We have audited the c accompanying balance sheet of Mera Pharmaceuticals, Inc. as of October 31, 2005 and the related statements of operations, changes in shareholders' equity`, and cash flows for the years ended October 31, 2005 and 2004. These financial statements are the responsibility of the Company's management. Our responsibility is to express an opinion on these financial statements based on our audits. We conducted our audits in accordance with the standards of the Public Company Accounting Oversight Board (United States). Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the financial statements are free of material misstatement. An audit includes examining, on a test basis, evidence supporting the amounts and disclosures in the financial statements. An audit also includes assessing the accounting principles used and significant estimates made by management, as well as evaluating the overall financial statement presentation. We believe that our audit provides a reasonable basis for our opinion. In our opinion, the financial statements referred to above present fairly, in all material respects, the financial position of Mera Pharmaceuticals, Inc. as of October 31, 2005 and the results of its operations and its cash flows for the years then ended 2005 and 2004 in conformity with accounting principles generally accepted in the United States of America. These accompanying financial statements referred to above have been prepared assuming that the Company will continue as a going concern. As more fully described in Note 2, the Company's need to seek new sources or methods of financing or revenue to pursue its business strategy, raise substantial doubt about the Company's ability to continue as a going concern. Management's plans as to these matters are also described in Note 2. The financial statements do not include any adjustments that might result from the outcome of this uncertainty. JEWETT, SCHWARTZ & ASSOCIATES Hollywood, Florida January 19, 2006 F-2 MERA PHARMACEUTICALS, INC. Balance Sheet October 31, 2005 ----------- ASSETS Current assets: Cash and cash equivalents $ 539 Accounts receivable, net 20,360 Inventories, net -- ----------- Total current assets 20,899 Plant and equipment, net 2,562,771 Other assets, net of accumulated amortization of $31,200 31,200 ----------- Total Assets $ 2,614,870 =========== LIABILITIES AND STOCKHOLDERS' EQUITY Current liabilities: Accounts payable, accrued liabilities and customer credits $ 301,654 Notes payable - related parties 77,336 Other current liabilities -- ----------- Total current liabilities 378,990 Commitments and contingencies Stockholders' equity: Convertible preferred stock, $.0001 par value, 10,000 shares authorized, 80 Series A shares issued and outstanding and 974 Series B shares issued and outstanding 2 Common stock, $.0001 par value: 750,000,000 shares authorized, 467,637,161 shares issued and outstanding 46,764 Additional paid-in capital 7,332,579 Accumulated deficit (5,143,465) ----------- Total stockholders' equity 2,235,880 ----------- Total Liabilities and Stockholders' Equity $ 2,614,870 =========== See the accompanying notes to the financial statements F-3 MERA PHARMACEUTICALS, INC. Statements of Operations
---------------- ---------------- Twelve Months Twelve Months Ended Ended October 31, 2005 October 31, 2004 ---------------- ---------------- Revenue Products $ 288,871 $ 672,204 Contract services 99,101 181,383 Royalties -- 56,026 ---------------- ---------------- Total Revenue 387,972 909,613 ---------------- ---------------- Costs and Expenses Cost of products sold 297,186 675,399 Cost of contract services 122,613 330,203 Research and development costs 168,964 110,924 General and administrative 533,778 672,750 Depreciation 217,276 135,032 Amortization 12,480 22,796 Provision for excess and obsolete inventory 349,073 323,000 ---------------- ---------------- Total costs and expenses 1,701,370 2,270,104 ---------------- ---------------- Operating loss (1,313,398) (1,360,491) Other income (expense): Interest income 655 -- Other income -- 227,535 Interest expense (10,194) (13,993) ---------------- ---------------- Total other income (expense) (9,539) 213,542 ---------------- ---------------- Net loss before extraordinary items (1,322,937) (1,146,949) Gain on discharge of debt -- 12,880 ---------------- ---------------- Net loss before income tax provision (1,322,937) (1,134,069) Tax expense -- -- Refundable tax credit 17,233 29,518 ---------------- ---------------- Net loss $ (1,305,704) $ (1,104,551) ================ ================ Loss per share - basic and diluted (0.003) (0.003) Weighted average shares outstanding - basic and diluted 467,637,161 426,547,939
See the accompanying notes to the financial statements F-4 MERA PHARMACEUTICALS, INC. Statements of Changes in Stockholders' Equity
Stock --------------------------------------------------- Convertible Preferred Common --------------------- ------ Additional Stockholders' Series A Series B Paid-In Accumulated Equity Shares Shares Amount Shares Amount Capital (Deficit) (Deficit) ----------------------------------------------------------------------------------------------- Balance at October 31, 2003 80 974 $ 2 405,643,926 $40,565 $4,675,262 $(2,733,210) $ 1,982,619 Shares returned and cancelled from a former employee of the company at par value (12,209,000) (1,221) 1,221 -- Shares re-issued to a former employee of the company at par value 5,341,437 534 (534) -- Issuance of common shares at $0.11 per share 2,590,909 259 284,741 285,000 Issuance of common shares at $0.11 per share 8,955,356 896 1,109,104 1,110,000 Issuance of common shares at $0.04 per share 7,954,545 795 749,205 750,000 Shares issuable at $0.04 per share 10,795,455 1,080 (1,080) -- Cancellation of discount on notes payable in connection with warrant issuances (82,564) (82,564) Loss for the year ended Ocober 31, 2004 (1,104,551) (1,104,551) ----------------------------------------------------------------------------------------------- Balance at October 31, 2004 80 974 $ 2 429,072,628 $42,908 $6,735,355 $(3,837,761) $ 2,940,504 ----------------------------------------------------------------------------------------------- Issuance of common shares at $0.11 per share 1,954,546 195 214,805 215,000 Issuance of common shares at $0.01 per share 38,549,237 3,855 381,637 385,492 Stock option exercise at $0.01 per share 60,750 6 602 608 Repurchase of stock at $0.00001 per share (2,000,000) (200) 180 (20) Loss for the year ended October 31, 2005 (1,305,704) (1,305,704) ----------------------------------------------------------------------------------------------- Balance at October 31, 2005 80 974 $ 2 467,637,161 $46,764 $7,332,579 $(5,143,465) $ 2,235,880 ===============================================================================================
See the accomanying notes to the financial statements F-5 MERA PHARMACEUTICALS, INC. Statements of Cash Flows
------------------------------------- Twelve Months Twelve Months Ended Ended October 31, 2005 October 31, 2004 ------------------------------------- Cash Flows from Operating Activities: Net loss $ (1,305,704) $ (1,104,551) Adjustments to reconcile net loss to net cash used in operating activities: Accumulated depreciation and amortization 268,061 274,074 Provision for excess and obsolete inventory 349,073 323,000 Common stock issued in exchange for services 7,000 -- Changes in operating Assets and Liabilities: Accounts receivable 38,447 31,873 Inventories (41) 305,470 Other current assets 3,224 (9,738) Accounts payable, accured expenses, and customer credits 101,518 (792,288) Deferred revenue (10,790) (248,232) Other current liabilities (18,281) (28,689) ------------------------------------- Net cash used by operating activities (567,493) (1,249,081) ------------------------------------- Cash Flows from Investing Activities: Purchases of fixed assets -- (14,592) ------------------------------------- Net cash used by investing activities -- (14,592) ------------------------------------- Cash Flows from Financing Activities Proceeds from issuance of common stock 548,251 2,145,000 Repurchase of common stock (20) -- Proceeds from notes payable 135,400 -- Payment of notes payable (120,000) (878,075) ------------------------------------- Net cash provided by financing activities 563,631 1,266,925 ------------------------------------- Net increase (decrease) in cash and cash equivalents (3,862) 3,252 Cash and cash equivalents, beginning of the period 4,401 1,149 ------------------------------------- Cash and cash equivalents, end of the period $ 539 $ 4,401 ===================================== Cash paid for taxes $ -- $ -- Cash paid for interest $ 602 $ 6,132 Supplemental cash flow information Non cash financing activities Common stock issued for payment of expenses due to related parties $ 19,705 $ -- ------------------------------------- Common stock issued in satisfaction of sales consignment agreement with a related party $ 26,144 $ -- ------------------------------------- Common stock issued for consulting services $ 7,000 ------------------------------------- Warrants cancelled $ -- $ 82,564 -------------------------------------
See the accompanying notes to the financial statements F-6 MERA PHARMACEUTICALS, INC. NOTES TO THE FINANCIAL STATEMENTS 1. SUMMARY OF ORGANIZATION AND SIGNIFICANT ACCOUNTING POLICIES Organization -- Mera Pharmaceuticals, Inc. (the "Company" or "Mera"), is the successor company to Aquasearch, Inc. Aquasearch was founded in February 1988. The Company develops and commercializes natural products from microalgae using its proprietary, large-scale photobioreactor technology. The Company's operations are located in Kailua-Kona, Hawaii. Microalgae are a diverse group of microscopic plants comprising an estimated 30,000 species that display a wide range of physiological and biochemical characteristics. Many of these organisms are known to contain valuable substances that have identified and potential commercial applications in such fields as animal and human nutrition, food colorings, cosmetics, diagnostic products, pharmaceuticals, research grade chemicals, pigments and dyes. Microalgae grow ten times faster than the fastest growing land-based crops and represent a largely unexploited and renewable natural resource with a biodiversity comparable to that of land-based plants. Mera Pharmaceuticals' first commercial product, AstaFactor(R), is a nutritional supplement based on astaxanthin, a naturally occurring red pigment derived from a freshwater microalga. The Company has devoted most of its efforts since inception to research and development, and was considered a development stage company until fiscal 2001. Cash and Cash Equivalents -- The Company considers all highly liquid debt securities purchased with original or remaining maturities of three months or less to be cash equivalents. The carrying value of cash equivalents approximates fair value. Fair Value of Financial Instruments - The carrying amounts of cash and cash equivalents, accounts receivable, accounts payable and accrued expenses approximate fair market value because of the short maturity of those instruments. Notes payable approximate fair value. Accounts Receivable - The Company performs ongoing credit evaluations of customers, and generally does not require collateral. Allowances are maintained for potential credit losses and returns and such losses have been within management's expectations. Credit Risk - It is the Company's practice to place its cash equivalents in high quality money market securities with two major banking institutions. Certain amounts of such funds are not insured by the Federal Deposit Insurance Corporation. However, the Company considers its credit risk associated with cash and cash equivalents to be minimal. Inventories -- Inventories are stated at the lower of cost (which approximates first-in, first-out)or market. At October 31, 2005, inventories consisted of $742,736 of work in process and $64,337 of finished goods. Management has recorded a full valuation allowance for obsolete and excess inventory totaling $807,073. F-7 MERA PHARMACEUTICALS, INC. NOTES TO THE FINANCIAL STATEMENTS Revenue Recognition -- Product revenue is recognized upon shipment to customers. Contract services revenue is recognized as services are performed on a cost reimbursement basis. Royalties are recognized upon receipt. The Company has adopted Securities and Exchange Commission's Staff Accounting Bulletin ("SAB") No. 104, which provides guidance on the recognition, presentation and disclosure of revenue in financial statements. Plant and Equipment, net -- Plant and equipment are stated at cost less accumulated depreciation. Depreciation is recorded principally using the straight-line method, based on the estimated useful lives of the assets (property and plant, 10-30 years; machinery and equipment, 3-10 years). When applicable, leasehold improvements and capital leases are amortized over the lives of respective leases, or the service lives of the improvements, whichever is less. Expenditures for renewals and improvements that significantly extend the useful life of an asset are capitalized. The costs of software with an expected life of more than one year, and used in the business operations are capitalized and amortized over their expected useful lives. Expenditures for maintenance and repairs are charged to operations when incurred. When assets are sold or retired, the cost of the asset and the related accumulated depreciation are removed from the accounts and any gain or loss is recognized at such time. Impairment of Long Lived Assets and Long Lived Assets to be Disposed Of -- Statement of Financial Accounting Standards ("SFAS") No. 144 "Accounting for the Impairment or Disposal of Long-Lived Assets establishes the accounting model for long-lived assets to be disposed of by sale and applies to all long-lived assets, including discontinued operations. This statement requires those long-lived assets be measured at the lower of carrying amount or fair value less cost to sell, whether reported in continuing operations or discontinued operations. Therefore, discontinued operations will no longer be measured at net realizable value or include amounts for operating losses that have not yet occurred. Intangible Assets -- The Company accounts for intangible assets in accordance with SFAS 142. Generally, intangible assets with indefinite lives, and goodwill, are no longer amortized; they are carried at lower of cost or market and subject to annual impairment evaluation, or interim impairment evaluation if an interim triggering event occurs, using a new fair market value method. Intangible assets with finite lives are amortized over those lives, with no stipulated maximum, and an impairment test is performed only when a triggering event occurs. Such assets are amortized on a straight-line basis over the estimated useful life of the asset. Intangible assets are reviewed for impairment whenever events or changes in circumstances indicate that the carrying amount may not be recoverable. If the fair value is less than the carrying amount of the asset, an impairment loss is then recognized. F-8 MERA PHARMACEUTICALS, INC. NOTES TO THE FINANCIAL STATEMENTS Stock Issued For Services -- The value of stock issued for services is based on management's estimate of the fair value of the Company's stock at the date of issue or the fair value of the services received, whichever is more reliably measurable. Preferred Stock -- The Company has authorized 10,000 shares of "blank check" preferred stock, with such designations, rights, preferences, privileges and restrictions to be determined by the Company's Board of Directors. As of October 31, 2005, 1,054 shares of preferred stock were issued and outstanding. Research and Development Costs Generally accepted accounting principles state that costs that provide no discernible future benefits, or allocating costs on the basis of association with revenues or among several accounting periods that serve no useful purpose, should be charged to expense in the period occurred. SFAS No. 2 "Accounting for Research and Development Costs" requires that certain costs be charged to current operations including, but not limited to: salaries and benefits; contract labor; consulting and professional fees; depreciation; repairs and maintenance on operational assets used in the production of prototypes; testing and modifying product and service capabilities and design; and, other similar costs. Income Taxes -- The Company uses the asset and liability method of accounting for income taxes as required by SFAS No. 109 "Accounting for Income Taxes". SFAS No. 109 requires the recognition of deferred tax assets and liabilities for the expected future tax consequences of temporary differences between the carrying amounts and the tax basis of certain assets and liabilities. Since its inception, the Company has incurred net operating losses. Accordingly, no provision has been made for income taxes. Loss Per Share -- The Company computed basic and diluted loss per share amounts for October 31, 2005 and 2004 pursuant to the SFAS No. 128, "Earnings per Share." The assumed effects of the exercise of outstanding stock options, warrants, and conversion of notes were anti-dilutive and, accordingly, dilutive per share amounts have not been presented in the accompanying statements of operations. Use of Estimates -- The preparation of financial statements in conformity with generally accepted accounting principles requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities, and disclosure of contingent assets and liabilities, at the date of these financial statements, and the reported amounts of revenues and expenses during the reporting period. Actual results could differ from those estimates. Recent Authoritative Pronouncements In November 2004, the FASB issued SFAS 151, "Inventory Costs." SFAS 151 amends the accounting for abnormal amounts of idle facility expense, freight handling costs, and wasted material (spoilage) UNDER THE GUIDANCE IN ARB 43, Chapter 4, "inventory Pricing" Paragraph 5 of ARB 42, Chapter 4, previously stated that "...under some circumstances, items such as idle facility expense, excessive spoilage, double freight, and rehandling costs may be so abnormal a to require treatment as current period charges..." This Statement requires that those items be recognized as current-period charges regardless of weather they meet the criterion of "so abnormal." In addition, this Statement requires that allocation of fixed production overheads to the costs of conversion be based on the normal capacity of the production facilities. This statement is effective for inventory costs incurred during fiscal years beginning after June 15, 2005. F-9 MERA PHARMACEUTICALS, INC. NOTES TO THE FINANCIAL STATEMENTS In December 2004, the FASB issued SFAS 152, "Accounting for Real Estate Time-Sharing Transactions." The FASB issued this Statement as a result of the guidance provided in AICPA Statement of Position (SOP) 04-2, "Accounting for Real Estate Time-Sharing Transactions." SOP 04-2 applies to all real estate time-sharing transactions. Among other items, the SOP provides guidance on the recording of credit losses and the treatment of selling costs, but does not change the revenue recognition guidance in SFAS 66, "Accounting for Sales of Real Estate," for real estate time-sharing transactions. SFAS 152 amends Statement 66 to reference the guidance provided in SOP 04-2. SFAS 152 also amends SFAS 67, "Accounting for Costs and Initial Rental Operations of Real Estate Projects", to state that SOP 04-2 provides the relevant guidance on accounting for incidental operations and costs related to the sale of real estate time-sharing transactions. SFAS 152 is effective for years beginning after June 15, 2005, with restatements of previously issued financial statements prohibited. In December 2004, the FASB issued SFAS 153, "Exchanges of Nonmonetary Assets," an amendment to Opinion No. 29, "Accounting for Nonmonetary Transactions." Statement 153 eliminates certain differences in the guidance in Opinion No. 29 as compared to the guidance contained in standards issued by the International Accounting Standards Board. The amendment to Opinion No. 29 eliminates the fair value exception for nonmonetary exchanges of similar productive assets and replaces it with a general exception for exchanges of nonmonetary assets that do not have commercial substance. Such an exchange has commercial substance if the future cash flows of the entity are expected to change significantly as a result of the exchange. SFAS 153 is effective for nonmonetary asset exchanges occurring in periods beginning after June 15, 2005. Earlier application is permitted for nonmonetary asset exchanges occurring in periods beginning after December 16, 2004. In December 2004, the FASB issued a revision of Statement of Financial Accounting Standards No. 123, "ACCOUNTING FOR STOCK-BASED COMPENSATION" ("SFAS 123R"). SFAS 123R supersedes APB Opinion No. 25, "ACCOUNTING FOR STOCK ISSUED TO EMPLOYEES," and its related implementation guidance. SFAS 123R establishes standards for the accounting for transactions in which an entity incurs liabilities in exchange for goods or services that are based on the fair value of the entity's equity instruments or that may be settled by the issuance of those equity instruments. SFAS 123R does not change the accounting guidance for share-based payment transactions with parties other than employees provided in SFAS 123 as originally issued and EITF Issue No. 96-18, "ACCOUNTING FOR EQUITY INSTRUMENTS THAT ARE ISSUED TO OTHER THAN EMPLOYEES FOR ACQUIRING, OR IN CONJUNCTION WITH SELLING, GOODS OR SERVICES." SFAS 123R is effective for the first interim or annual reporting period of the company's first fiscal year that begins on or after June 15, 2005. In March 2005, the U.S. Securities and Exchange Commission, or SEC, released Staff Accounting Bulletin 107, "Share-Based Payments," ("SAB 107"). The interpretations in SAB 107 express views of the SEC staff, or staff, regarding the interaction between SFAS 123R and certain SEC rules and regulations, and provide the staff's views regarding the valuation of share-based payment arrangements for public companies. In particular, SAB 107 provides guidance related to share-based payment transactions with non-employees, the transition from nonpublic to public entity status, valuation methods (including assumptions such as expected volatility and expected term), the accounting for certain redeemable financial instruments issued under share-based payment arrangements, the classification of compensation expense, non-GAAP financial measures, first-time adoption of SFAS 123R in an interim period, capitalization of compensation cost related to share-based payment arrangements, the accounting for income tax effects of share-based payment arrangements upon adoption of SFAS 123R, the modification of employee share options prior to adoption of SFAS 123R and disclosures in Management's Discussion and Analysis subsequent to adoption of SFAS 123R. SAB 107 requires stock-based compensation be classified in the same expense lines as cash compensation is reported for the same employees. F-10 MERA PHARMACEUTICALS, INC. NOTES TO THE FINANCIAL STATEMENTS In March 2005, the FASB issued FASB Interpretation ("FIN") No. 47 "ACCOUNTING FOR CONDITIONAL ASSET RETIREMENT OBLIGATIONS--AN INTERPRETATION OF FASB STATEMENT NO. 143" ("FIN No. 47"). FIN No. 47 clarifies the timing of liability recognition for legal obligations associated with the retirement of a tangible long-lived asset when the timing and/or method of settlement are conditional on a future event. FIN No. 47 is effective for us no later than December 31, 2005. In May 2005, the FASB issued SFAS No. 154, "ACCOUNTING CHANGES AND ERROR CORRECTIONS, A REPLACEMENT OF APB NO. 20 AND FASB STATEMENT NO. 3" ("SFAS No.154"). SFAS No. 154 requires retrospective application to prior periods' financial statements of a voluntary change in accounting principle unless it is impracticable. APB Opinion No. 20 "Accounting Changes," previously required that most voluntary changes in accounting principle be recognized by including in net income of the period of the change the cumulative effect of changing to the new accounting principle. 2. GOING CONCERN These financial statements have been prepared assuming that the Company will continue as a going concern. The Company has operating and liquidity concerns, has incurred an accumulated deficit of approximately $5,200,000 through the year ended October 31, 2005. The Company anticipates that future revenue will be sufficient to cover certain operating expenditures, and, in the interim, will continue to pursue additional capital investment. However, there can be no assurance that the Company will be able to successfully acquire the necessary capital to continue their on-going development efforts and bring products to the commercial market. These factors, among others, create an uncertainty about the Company's ability to continue as a going concern. 3. RELATED PARTY TRANSACTIONS In March 2003 the Company entered into an agreement with a partnership of which a director of the Company is a general partner. Under the terms of the agreement the Company sold certain inventory for $76,000 to the partnership and had the right to resell the inventory. Upon the resale of such inventory, the Company was obligated to repay the partnership the price it paid for the inventory plus 10%. During the year ended October 31, 2005, the Company had repaid all amounts due under this arrangement totaling approximately $26,000 in 2,614,370 shares of the company's common stock. In December 2003 the Board agreed to pay one of its members a commission of 4.0% of sales made to a Hawaiian distributor. The commission amount to be paid is based on sales consummated retroactive to May 2003 and approximately $9,400 was payable under this agreement as of October 31, 2005. In February 2004, the Company agreed to pay $55,000 cash plus certain inventory amounts to a shareholder and former officer. The payment is in satisfaction of a debt of $125,000 plus accrued interest owed to the individual. F-11 MERA PHARMACEUTICALS, INC. NOTES TO THE FINANCIAL STATEMENTS 4. INCOME TAXES The Company provides for income taxes in accordance with SFAS No. 109 using an asset and liability based approach. Deferred income tax assets and liabilities are recorded to reflect the tax consequences on future years of temporary differences of revenue and expense items for financial statement and income tax purposes. Since its formation the Company has incurred net operating losses. As of October 31, 2005, the Company had a net operating loss carryforward available to offset future taxable income for federal and state income tax purposes. SFAS No. 109 requires the Company to recognize income tax benefits for loss carryforwards that have not previously been recorded. The tax benefits recognized must be reduced by a valuation allowance if it is more likely than not that loss carryforwards will expire before the Company is able to realize their benefit, or that future deductibility is uncertain. For financial statement purposes, the deferred tax asset for loss carryforwards has been fully offset by a valuation allowance since it is uncertain whether any future benefit will be realized. The provision (benefit) for income taxes from continued operations for the years ended October 31, 2005 and 2004 consist of the following: October 31, ---------------------- 2005 2004 --------- --------- Current: Federal $ -- $ -- State -- -- --------- --------- -- -- Increase in valuation allowance (520,000) (440,000) Benefit of operating loss carryforward 520,000 440,000 --------- --------- Provision (benefit) for income taxes, net $ -- $ -- ========= ========= F-12 MERA PHARMACEUTICALS, INC. NOTES TO THE FINANCIAL STATEMENTS Deferred income taxes result from temporary differences in the recognition of income and expenses for the financial reporting purposes and for tax purposes. The tax effect of these temporary differences representing deferred tax asset and liabilities result principally from the following: October 31, -------------------------- 2005 2004 ----------- ----------- Net operating loss carry- forwards expiring after the year 2009 $ 8,080,000 $ 7,520,000 ----------- ----------- Deferred income tax asset $ 8,080,000 $ 7,520,000 =========== =========== The net deferred tax assets and liabilities are comprised of the following: October 31, -------------------------- 2005 2004 ----------- ----------- Deferred tax assets Current $ -- $ -- Non-current 8,080,000 7,520,000 ----------- ----------- 8,080,000 7,520,000 Less valuation allowance (8,080,000) (7,520,000) =========== =========== Net deferred income tax asset $ -- $ -- =========== =========== At October 31, 2005, the Company has available net operating loss carry forwards of approximately $20,000,000 that expire in various years beginning in 2009 through 2025. The Company is a Qualified High Tech Business ("QHTB") in the State of Hawaii. QHTBs qualify for certain refundable state tax credits as they relate to research and development activities ("QHTB tax credit refunds"). During the year ended October 31, 2005, the Company has approximately $12,000 in QHTB tax credit refunds receivable. F-13 MERA PHARMACEUTICALS, INC. NOTES TO THE FINANCIAL STATEMENTS 6. NOTES PAYABLE - RELATED PARTIES Notes payable - related parties consists of the following as of October 31, 2005: Unsecured demand notes payable - shareholder notes bearing an annual interest rate of 10% due on March 31, 2004. Notes are currently past maturity, however no demand for payment has been made. $ 41,936 Unsecured demand notes payable - shareholder notes bearing an annual interest rate of 8% due on various dates through March 26, 2006. 35,400 Total notes payable, related parties $ 77,336 Total interest expense on notes payable - related parties was $8,960 and $13,993 for the years ended October 31, 2005 and 2004, respectively. 7. COMMON STOCK, PREFERRED STOCK AND COMMON STOCK PURCHASE WARRANTS During 2003, the Company issued detachable stock purchase warrants in connection with notes payable issued to certain directors and shareholders of the Company. These warrants grant the right to purchase up to an aggregate of 5,520,000 shares of common stock at $0.05 per share and the warrants have 5-year terms that expire during the fiscal year ended 2008. These transactions were exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). The fair market value of the stock purchase warrants at the time of issuance was approximately $165,600. This amount was recorded as additional paid-in capital and will be amortized over the 5 year term or until exercised. During 2004, 3,440,000 warrants with a value of $103,000 were cancelled. In December 2003, the Company issued 16,909,901 shares of common stock at a price of $0.11 per share, for aggregate consideration of $1,860,000, to a limited liability company. That company is managed in part by certain stockholders, officers and directors of the Company. This transaction was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In December 2003, the Company issued 2,590,909 shares of its common stock to an investor at a per share price of $0.11 and aggregate consideration of $285,000. This investment was made in fulfillment of the conditional subscription agreement referred to in previous financial statements of the Company. In December 2004, the Company issued a total of 1,954,546 shares of its common stock to two investors in exchange for investment totaling $215,000, resulting in an effective share price of $0.11 for the shares sold. These issuances were exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In December 2004, the Company issued 7,954,545 shares of its common stock in fulfillment of a subscription entered into before the period in question. The share price of this second issuance was $0.04. This issuance was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). An additional 2,840,910 shares will be issued at a future date in fulfillment of this subscription. F-14 MERA PHARMACEUTICALS, INC. NOTES TO THE FINANCIAL STATEMENTS In December 2004, the Company repurchased 2,000,000 shares of its common stock from a former employee for $20 representing the employee's original cost. The repurchase was made according to the terms of the former employee's contract. The stock issuance was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In March 2005 the Company issued a total of 700,000 shares of common stock at $0.01 per share to consultants in compensation for their services. These issuances were exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In March 2005 the Company issued 2,614,370 shares of its common stock to Aquasearch Investment Partners, a general partnership, in exchange for cancellation of a debt in the amount of $26,143 owed to it under a factoring agreement previously entered into, or an effective price of $0.01 per share. Gregory F. Kowal, the chairman of the Company's board of directors, is a general partner of Aquasearch Investment Partners. This issuance was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In March 2005 the Company issued 400,000 shares of stock to Anthony E. Applebaum, the Company's principal accounting and financial officer, in exchange for his forgiveness of the amount of $4,000 owed to him for services rendered, or an effective per share price of $0.01. This issuance was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In March 2005 the Company issued 87,298, 1,354,028 and 1,582,771 to Gregory F. Kowal, Daniel P. Beharry and Kenneth Crowder, respectively, in exchange for their forgiveness of debts in the amount of $872, $13,540 and $15,827 owed to them by the Company for expenses incurred by them on the Company's behalf. The effective per share price of these issuances was $0.01 per share. Messrs. Kowal, Beharry and Crowder are all members of Mera's board of directors. These issuances were exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In March 2005 the Company issued 10,000,000 shares of its common stock to an investor in exchange for investment of $100,000, a per share price of $0.01 per share. This issuance was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In March and April 2005 the Company issued 6,810,770 shares to Gregory F. Kowal, the chairman of the Company's board of directors, in exchange for total investment of $68,107, a per share price of $0.01. This issuance was exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In May 2005 the Company issued a total of 15,000,000 shares of common stock to private investors for aggregate consideration of $150,000. These issuances were exempt from registration under the Securities Act of 1933, as amended, pursuant to Section 4(2). In August 2005 the Company repurchased a total of 11,884,800 shares of its common stock from a former employee for total consideration of $118.80 pursuant to a stock repurchase agreement. F-15 MERA PHARMACEUTICALS, INC. NOTES TO THE FINANCIAL STATEMENTS Beginning March 16, 2005, the Company sought written consent from shareholders as to two matters. One matter was to permit the amendment of the Company's certificate of incorporation to increase the authorized common stock from 500,000,000 shares to 750,000,000 shares. The other was to obtain shareholder approval of an employee stock option plan approved by the board of directors on November 7, 2004. Both proposals required a majority vote of the issued and outstanding stock of the Company to pass. The votes needed for approval of both measures were received during May 2005. Company's certificate of incorporation has not yet been amended to reflect the increase in authorized stock. The following is a summary of the Company's outstanding common stock purchase warrants as of October 31, 2005: ------------------------------------------------------------------------- Exercise Price Outstanding at Issued Exercised Outstanding at October 31, 2004 October 31, 2005 ------------------------------------------------------------------------- $0.05 2,080,000 - - 2,080,000 -------------------------------------------------------- 2,080,000 - - 2,080,000 -------------------------------------------------------- The Company has reserved a sufficient number of shares of its authorized common stock for issuance upon exercise of the outstanding warrants. 8. STOCK BASED COMPENSATION On November 7, 2004 the Board of Directors adopted the 2004 Stock Option Plan, authorizing issuance of options on up to 60 million shares of the Company's common stock. In December of 2004, the Board approved issuance of options to purchase approximately 48,000,000 shares of its common stock to existing officers, directors and employees, subject to shareholder approval of the plan. In May 2005, such approval was received. As of October 31, 2005, approximately 35,000,000 were deemed vested based on length of service with the Company since the date the Company's Plan of Reorganization was approved. The fair value of the options on the grant date was $480,000 calculated using the Black-Scholes Option Pricing Model. The Company applies Accounting Principles Board Opinion No. 25, "ACCOUNTING FOR STOCK ISSUED TO EMPLOYEES," in accounting for stock-based employee compensation arrangements whereby no compensation cost related to stock options is deducted in determining net income or loss. Had compensation cost for stock option grants to the Company's employees been determined pursuant to SFAS No. 123, "ACCOUNTING FOR STOCK-BASED COMPENSATION," the Company's net income would have decreased for the year ended July 31, 2001 as presented in the table below. Using the Black-Scholes option pricing model, the Company's pro forma net loss and pro forma net loss per share, with related assumptions, are as follows: F-16 Pro forma net loss $(1,800,000) Pro forma loss per share $ (0.001) Risk free interest rate 2.00% Expected lives 5-10 years Expected volatility 168% For purposes of these pro forma disclosures, the estimated fair value of the options granted is amortized over the options' vesting period (0 to 5 years). The following table summarizes the transactions of the Company's stock options for the two-year period ended October 31, 2005: Weighted Average Number of Shares Exercise Price ================================================================================ Options outstanding, November 1, 2004 -- $ -- Options granted 48,426,800 0.010 Options exercised (60,750) 0.010 Options forfeited -- -- - -------------------------------------------------------------------------------- Options outstanding, October 31, 2005 48,366,050 0.010 ---------- ------ Options to purchase 34,534,454 shares were exercisable at October 31, 2005. 9. CUSTOMER CONCENTRATION Revenue from sales to the Company's two major customers for the year ended October 31, 2005 amounted to 19% and 14% respectively. No accounts receivable were outstanding from either customer at fiscal year end. 10. PROPERTY, PLANT AND EQUIIPMENT, NET Property, Plant and Equipment is as follows: ---------------------------------------------- October 31, 2005 ---------------------------------------------- Plant 2,621,614 Equipment 712,179 ---------------------------------------------- 3,333,793 Accumulated depreciation -771,022 ---------------------------------------------- 2,562,771 ---------------------------------------------- F-17 MERA PHARMACEUTICALS, INC. NOTES TO THE FINANCIAL STATEMENTS 11. SUBSEQUENT EVENTS In December 2005, the Company received additional equity financing in the amount of $150,000 in exchange for common stock issued at a per share price of $0.013. This additional financing was the fulfillment of a conditional subscription agreement entered into by the purchasers during fiscal 2005. 12. INTANGIBLE ASSETS The Company issued detachable stock purchase warrants with an aggregate fair market value of $165,600 that expire in 2008. During the year ended October 31, 2004, 3,440,000 warrants were cancelled with an aggregate value of $103,000. For the year ended October 31, 2005 the Company recognized amortization expense of $12,480. Estimated amortization expense for each of the years ended October 31, is as follows: 2006: $12,480 2007: $12,480 2008: $ 6,240 F-18
EX-31.1 2 exh31-1.txt RULE 13A-14(A)/15D-14(A) CERTIFICATIONS CERTIFICATIONS Exhibit 31.1 I, Gregory F. Kowal, certify that: 1. I have reviewed this quarterly report on Form 10-QSB of Mera Pharmaceuticals, Inc.; 2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; 3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; 4. The Company's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and have: a) designed such disclosure controls and procedures to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; b) evaluated the effectiveness of the Company's disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the "Evaluation Date"); and c) presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; 5. The Company's other certifying officers and I have disclosed, based on our most recent evaluation, to the Company's auditors and the audit committee of Company's board of directors (or persons performing the equivalent functions): a) all significant deficiencies in the design or operation of internal controls which could adversely affect the Company's ability to record, process, summarize and report financial data and have identified for the Company's auditors any material weaknesses in internal controls; and b) any fraud, whether or not material, that involves management or other employees who have a significant role in the Company's internal controls; and 6. The Company's other certifying officers and I have indicated in this quarterly report whether there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. Date: February 13, 2006 /s/ Gregory F. Kowal - ----------------------- Gregory F. Kowal Chief Executive Officer EX-31.2 3 exh31-2.txt RULE 13A-14(A)/15D-14(A) CERTIFICATIONS Exhibit 31.2 I, Anthony E. Applebaum, certify that: 1. I have reviewed this quarterly report on Form 10-QSB of Mera Pharmaceuticals, Inc.; 2. Based on my knowledge, this quarterly report does not contain any untrue statement of a material fact or omit to state a material fact necessary to make the statements made, in light of the circumstances under which such statements were made, not misleading with respect to the period covered by this quarterly report; 3. Based on my knowledge, the financial statements, and other financial information included in this quarterly report, fairly present in all material respects the financial condition, results of operations and cash flows of the registrant as of, and for, the periods presented in this quarterly report; 4. The Company's other certifying officers and I are responsible for establishing and maintaining disclosure controls and procedures (as defined in Exchange Act Rules 13a-14 and 15d-14) for the registrant and have: d) designed such disclosure controls and procedures to ensure that material information relating to the Company, including its consolidated subsidiaries, is made known to us by others within those entities, particularly during the period in which this quarterly report is being prepared; e) evaluated the effectiveness of the Company's disclosure controls and procedures as of a date within 90 days prior to the filing date of this quarterly report (the "Evaluation Date"); and f) presented in this quarterly report our conclusions about the effectiveness of the disclosure controls and procedures based on our evaluation as of the Evaluation Date; 5. The Company's other certifying officers and I have disclosed, based on our most recent evaluation, to the Company's auditors and the audit committee of Company's board of directors (or persons performing the equivalent functions): c) all significant deficiencies in the design or operation of internal controls which could adversely affect the Company's ability to record, process, summarize and report financial data and have identified for the Company's auditors any material weaknesses in internal controls; and d) any fraud, whether or not material, that involves management or other employees who have a significant role in the Company's internal controls; and 6. The Company's other certifying officers and I have indicated in this quarterly report whether there were significant changes in internal controls or in other factors that could significantly affect internal controls subsequent to the date of our most recent evaluation, including any corrective actions with regard to significant deficiencies and material weaknesses. Date: February 13, 2006 /s/ ANTHONY E. APPLEBAUM - ------------------------------------------ Anthony E. Applebaum Principal Financial and Accounting Officer EX-32.1 4 exh32-1.txt SECTION 1350 CERTIFICATIONS Exhibit 32.1 CERTIFICATION PURSUANT TO 18 UNITED STATES CODE SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 I, Gregory F. Kowal, Chief Executive Officer of Mera Pharmaceuticals, certify that (1) Mera Pharmaceuticals, Inc.'s Form 10-KSB for the fiscal year ended October 31, 2005 fully complies with the requirements of Section 3 (a) or 15 (d) of the Securities Exchange Act of 1934 and (ii) the information contained in the Form 10-KSB for the fiscal year ended October 31, 2005 fairly presents, in all material respects, the financial condition and the results of operations of Mera Pharmaceuticals, Inc. /s/ Gregory F. Kowal ----------------------- Gregory F. Kowal Chief Executive Officer February 13, 2006 A signed original of this written statement required by Section 906 has been provided to Mera Pharmaceuticals, Inc. and will be retained by Mera Pharmaceuticals, Inc. and furnished to the Securities and Exchange Commission or its staff upon request. EX-32.2 5 exh32-2.txt SECTION 1350 CERTIFICATIONS Exhibit 32.2 CERTIFICATION PURSUANT TO 18 UNITED STATES CODE SECTION 1350, AS ADOPTED PURSUANT TO SECTION 906 OF THE SARBANES-OXLEY ACT OF 2002 I, Anthony E. Applebaum, Chief Executive Officer of Mera Pharmaceuticals, certify that (1) Mera Pharmaceuticals, Inc.'s Form 10-KSB for the fiscal year ended October 31, 2005 fully complies with the requirements of Section 3 (a) or 15 (d) of the Securities Exchange Act of 1934 and (ii) the information contained in the Form 10-KSB for the fiscal year ended October 31, 2005 fairly presents, in all material respects, the financial condition and the results of operations of Mera Pharmaceuticals, Inc. /s/ Anthony E. Applebaum ------------------------------------------ Anthony E. Applebaum Principal Financial and Accounting Officer February 13, 2006 A signed original of this written statement required by Section 906 has been provided to Mera Pharmaceuticals, Inc. and will be retained by Mera Pharmaceuticals, Inc. and furnished to the Securities and Exchange Commission or its staff upon request.
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