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Viragen`s CEO, Charles A. Rice, Outlines Growth Strategy to Stockholders PLANTATION, Fla., May 25 /PRNewswire-FirstCall/ -- The following is a letter from the President and CEO of Viragen, Inc. (Amex: VRA). In addition to these comments, stockholders and potential investors are referred to the Company`s SEC filings, including Form 10-K and Form 10-Q (Annual and Quarterly Reports); press releases; Website; and other publicly disseminated information which is available upon request by contacting the Company. Dear Stockholder, Nearing the completion of my first 60 days as President and CEO, I would like to report to you on some progress we are making at Viragen. I believe there is an existing foundation here that is ripe to create immediate and long-term value for our stockholders. While there are significant challenges which need to be navigated to be successful, we are making changes now that will direct us toward that success. I am establishing a renewed focus to maximize the value of our assets for our stockholders. Because some of our growth strategies are in the process of being negotiated, I cannot discuss all of my plans in this letter. However, I would like to update you on certain activities, including some new initiatives designed to enhance and complement those which have been ongoing and progressing. There are two things that we must do, these being: 1) increase revenues and 2) continue to control expenses. Multiferon(TM) Manufacturing -- We have previously announced the ongoing process of modernizing our production capabilities for the manufacturing of Multiferon(TM) in Sweden. I am pleased to report that we are on schedule to complete the validation of the new construction and subsequent inspection by Swedish authorities before the end of this year. I would like to congratulate our team for their excellent work on this important project. I would also like to stress the importance of state-of-the-art and fully compliant manufacturing facilities, equipment and processes for the production of Multiferon. We can be very proud of our Ersboda and Umea sites. Continuous improvement in our manufacturing systems is one of the best possible uses of our capital. Marketing -- There is no better short-term means to build value in Viragen than to increase the sales of Multiferon. This is a great product but it has been under the radar screen of high prescribers in territories where it is approved. It requires new marketing initiatives to meet our expectations. I am pleased to report that we have put into effect several changes in order to achieve our new objective of making Multiferon the world`s most prescribed natural human alpha interferon. First, our analysis of the current market situation in Sweden indicates this is the opportune time to boost our sales activity. We recently announced a new advertising campaign coupled with a sales strategy that we are confident will result in sales increases over the coming months. We will ensure our return on this reasonably small investment is accounted for in a very short period of time. Sweden is the only territory, at the current time, where Viragen or one of its subsidiaries is in direct control of selling Multiferon. We must take advantage of this unique opportunity now. Second, we are conducting a critical review, or "rationalization", of all our international distribution agreements. As part of this review, we will be making determinations as to whether to continue in certain territories or whether to halt our activities. As our marketing and regulatory resources are limited, we cannot afford to maintain product registrations in territories unless the financial return justifies the expense. Our approach will be to focus our attention on higher value opportunities. Third, we are evaluating packaging alternatives for Multiferon in order to improve our competitiveness. Our glass ampoule presentation represents a classic approach to biological product manufacturing. However, most of our competitors use pre-filled syringes, adding to end-user convenience. While any such changes will require approvals by local authorities, this is a necessary step in managing the expectations of physicians, nurses and patients as well as positioning Multiferon for future growth. Fourth, we are currently reviewing the regulatory alternatives for our clinical assessment of Multiferon in malignant melanoma. We are in the process of additional data collection and we expect to provide updates to you later this year on this important part of our strategy. Finally, there are discussions and negotiations currently in progress on License and Supply Agreements for Multiferon in territories where we currently do not have a market presence, and where significant opportunities exist. These include selected areas of Asia, South America, Europe and North America. We are changing our strategy on these agreements, including our selection of collaborators. We are not going to be satisfied with merely signing agreements. Performance and growth are our priority expectations. Based upon these and other activities, I am confident that we will realize significant improvements in revenues from Multiferon. The U.S. Market -- With respect to the U.S. market, we have stated that, upon closing our $20 million financing agreement, we intend to use a portion of the proceeds to seek a market registration for Multiferon in the U.S. While we recognize that this process will take time and money, we know there are many different regulatory pathways available to us. We will be as creative and innovative as possible in developing a U.S. strategy. Where possible, we will make use of tools available to small businesses, tools available for niche market opportunities, and potential partnerships, whereby we may share costs of the registration processes. If approved by Congress and the President, Project BioShield could provide a new alternative for accelerated registration, provided our products demonstrate utility in treating biological, chemical or radiation contamination. Multiferon has been demonstrated to have significant anti- viral activity in SARS in cell-based assays, and we may expect this to be active against a variety of viruses that could be used in bio-terrorism. We have been working on an international level to generate the necessary scientific data in support of Multiferon just for these purposes, and this work will continue. The critical parameter here is not just to talk about it, but to find a way to do it, and we will. Avian Transgenic Biomanufacturing Technology The most obvious question is, "When will the flocks of our genetically- engineered chickens be capable of producing therapeutic proteins faster, cheaper and more efficiently than conventional methods?" There is no simple answer. This is a major research project that aims to revolutionize a drug manufacturing process. The market opportunity appears to be enormous and the competition fierce. So, while we, with our partners, strive to meet internal deadlines, it is important to realize that this is discovery research. It is difficult to predict and it is not guaranteed. We are extremely encouraged by our accomplishments to date, and we believe these are but a precursor of achievements to come. We have some of the most outstanding people, partners and patents in this field, and our team is working hard to prove commercial viability. We are determined to provide our research team with the resources necessary to deliver this important technology. Anti-Cancer Projects We have three promising anti-cancer candidates that are being developed in collaboration with four separate and prestigious institutions, each recognized leaders in fields of cancer and immunology research. The recent grant from the Scottish Executive confirms both the credibility and innovative nature of our anti-CD55 Antibody and provides incremental funding ($833,000 over 3 years) so that we can move forward with development. Whenever possible, we will continue to utilize creative financing efforts for all of our projects. The industry is quite crowded with product candidates for the treatment of cancers. It is important that we develop sound scientific data on our candidates on as timely a basis as practical so that we can either move forward with development or stop spending money on them if they do not work. In order to realize value from these projects, we have to invest in them. Financing We are currently seeking stockholder approval to complete a $20 million financing agreement and to effect a 1-for-10 reverse stock split. Our Board believes these actions are necessary to enable the Company to meet its goals and build stockholder value. The intent is to recapitalize the Company in order to make our capital structure more attractive to institutional investors and professional fund managers. Adding these types of investors to our stockholder mix can help to reduce the volatility that we experience now. Coupled with improving business conditions, such as increasing sales, we expect this new financing to provide sufficient funding to allow us to move forward on our projects and ultimately build value. I believe the financing and reverse split are necessary to adequately fund our operations and to advance our development projects and I fully support these actions. The Future I am focused on building the business. To my knowledge, there are no sales or marketing initiatives that can be guaranteed to generate immediate revenues, short of introducing a completely new product. It will take a number of months for us to realize significant increases in sales revenues, but I am confident it will happen. In the past two months, I have had the opportunity to meet only a few of our stockholders. Some of you have been holding shares for many years and some of you are new investors, but all of you are keenly interested in seeing your investment grow. In the coming months, I hope to be able to announce a number of events that could represent major advancements in our business. As part of our communications, I intend to ensure that we maintain an active investor information program to report to you, the stockholder, our progress -- good or bad -- factually, accurately and as timely as possible, within the laws that govern our business. Approaching my first 60 days as the President and CEO of Viragen, I am excited about the prospects for our Company. I also believe that tangible business accomplishments will speak louder than any predictions, and that is what you can expect from Viragen management. Sincerely yours, Charles A. Rice President & CEO Fraktal |
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| aus der Diskussion: | Viragen - aktueller Artikel im Science Magazin |
| Autor (Datum des Eintrages): | Frakt@l (25.05.04 18:19:40) |
| Beitrag: | 120 von 128 (ID:13224136) |
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