Calypte und die Zeit nach AIDS2004 in Bangkok
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19.10.05 22:59
#5027
Kade_I
Der letzte Conference Call in Textform:
Report from the Chairman, Roger Gale
10/14/05, 11:00 am ET.
Good morning and thank you for joining us today on this Call. I am Roger Gale, the Chairman and interim CEO of Calypte Biomedical. I was appointed interim CEO by the board of directors on October 5, 2005 pursuant to section 5.6 of the Companyfs bylaws. I have served as Chairman of the board since November 2004. Since my election as Chairman of the Company last year I have worked with the board and senior management on the initiatives to restructure the Company. These initiatives where undertaken to increase efficiency and reduce the cash burn rate in the short term. While more clearly identifying and implementing its longer term objectives and strategies. All of us associating with Calypte have been and continue to work diligently with these goals in mind. On the resignation of Dr. George as President CEO, I asked for and was granted a leave of absence as Executive Chairman of the board of directors of Wavecrest Group Enterprises so that I could work with Calypte to ensure that the direction and momentum developed under Dr. Georgefs leadership was maintained for the period of time that we require to search for and appoint a new President and CEO for the Company. By way of background, Wavecrest is a UK based international telecommunications service provider. I was a co-founder and one of the initial investors in the Company. Over the past four years, since its inception it has grown from $0 to $27 million dollars per month in revenues. With annual 2005 revenues expected to be around $300 million dollars. The Company is now approaching financial viability. As you know the Marr Group is also a major shareholder in Wavecrest. What that means to Calypte is that a major shareholder believes strongly in the Calypte story. So much so that Ifve been able to make this choice to take a more active roll in the Company as we take Calypte forward. And Ifm not shy about telling you that I have considerable experience in conducting the type international business that we see in Calyptefs future. Additionally Ifm a member of the Board of Directors and of the Audit Committee of Mechel Group an integrated coal and steel group based in Moscow, Russia. Mechel is listed on the New York Stock Exchange. I take very seriously my fiduciary responsibilities as a board member of that Company and indeed equally in Calypte. As you know, we recently announced the resignations of Dr. Richard George and Dick Van Maanen our Vice President - Operations and International development. Dr. George will be staying with us for the foreseeable future as a scientific advisor and in this capacity he will be devoting much of his time to the science supporting the development and evaluations of our new products and working closely with the CDC and other government agencies in the US and around the world. We are pleased that he will continue to have access, we are pleased sorry, that we will continue to have access to his scientific expertise in this advisory capacity. Dick Van Maanen will also stay on as a consultant for a period of time.
Let me take this opportunity to provide you with a couple of operational updates. In China, as we have previously advised, we expect to file shortly for SFDA approval of our Oral Fluid Rapid Test. And we ask you to stay tuned for news of the actual filings. We believe it will still qualify for the fast track ggreen passh which may still take approximately 90 days from the date of submission to approval. We have just dispatched our Chief Science Officer, Dr. Ron Mink to China to wrap up the filings. We believe we are close to concluding the sale of our legacy business products to Maxim. This transaction has been complicated by fact the FDA regulated Rockville facility and the IP licenses related to the products produced there have all been transferred as part of the commercial transaction. The facility has been running smoothly for the past several months under Maximfs management. We plan to provide more detail regarding the Companyfs operational financial status when we release the 3rd quarter 2005 results in mid November. For now however, let me reiterate that we believe that we have access to sufficient resources to continue our operations as we continue to execute on our defined business plans. As I said in the beginning of our presentation, we continue to work very hard to achieve our targets and execute our strategies. I realize we have much more to do. We will continue to update you as things progress. Thank you for your participation in todayfs call and this concludes my formal remarks and I think we are now ready to open this up for questions. So, operator kindly go ahead and Tim return to you, thank you.
Q&A Session
Sir, we have a question from the line of Tom DeHooty with (unknown word) Asset Management.
Tom: Good morning! Can you give us a little more background as to why all these management places took place at the same time?
Roger: Thank you, Roger Gale here. I think first of all we must separate the changes in two parts. The first was, the first set of changes were related to the restructuring. Ted Gwen who had been with us as an officer in the financial group was appointed CFO as a part of that restructuring. Also part of that restructuring, which Rick Brounstien, who was CFO, as we moved up to Portland, Rick decided not to move up to Portland with the Company. But Rick has agreed to stay on as Executive Vice President. So those are two of the changes. The resignation of Dr. George was an entirely separate matter. At the time of Dr. Georgefs resignation we also received the resignation of Dr., sorry, Dick Van Maanen. The two I suppose were related in the sense that, Dick Van Maanen whofd been with the Company twelve and a half years clearly felt that it was an appropriate time for him to resign also. However, as we have said both Dr. George and Mr. Van Maanen will be remaining with the Company for the foreseeable future as advisors to the Company; respectively on the area of science advisor and on the basis of marketing consultant.
Tom: And what will Rick Brounstien's functional responsibilities be going forward?
Roger: Rick Brounstien as Executive Vice President going forward, he will be advising the Company in all aspects of the capital markets, aspects related to any requirements for fund raising, any aspects related to investor relations and also providing guidance to me as interim CEO and the new CEO which we will appoint in terms of the overall structure of the Company. He will be in the longer term, we hope, our link to the historical knowledge of the Company. And I am absolutely delighted hefs staying on with us even thought he has not moved up to Portland to join us.
Tom: And one last management question. Are you anticipating bringing any other additional management talent in besides the new CEO?
Roger: Good question! I think Ifve only been on the job, just my third day and Ifm just getting my arms around the Company itself. As Chairman of the Company of course, my responsibilities and depth of understanding is at one particular level. To run the Company is another level of understanding. I think we will have to look at this very closely. It is certainly part and parcel of the overall restructuring of the Company. But potentially, Ifm not making a commitment here, but potentially the Company may need a Chief Operating Officer to support the Chief Executive Officer. The reason I say this is the Company is beginning to grow in terms of outreach into the developing world, in the emerging world and the day to day responsibilities will soon be growing to such an extent that no single CEO will be able to keep his arms around all the operational developments. So, I think thatfs where initially I do see a need, perhaps for some additional management expertise.
Moderator: Sir our next question is from the line of Al Kildony with SF Capital.
Al: Good morning! I wonder if you could provide a little more color regarding the time frame for various regulatory time lines and different countries. I know youfve provided some guidance for China, anything else you can say about progress being made in African nations and other nations in South East Asia that could be of significance to Calypte?
Roger: Could I kindly ask Rick Brounstien if he will field that question please?
Rick: Well Al, hi! Itfs a tough question. Wefll probably try to do a much more complete assessment in a couple weeks when we get on the quarter and conference call. You guys have been seeing various announcements as the, as we get approvals in various countries or as we sign up distributors in that; there are probably, oh I would say 20 or so countries, many in Africa some in South East Asia that are targeted over the next 12 months. A lot of them tied into the PEPFAR money, the US funds supporting some of these poorer countries. All I can do is say, gstay tuned as these things break. And obviously they break on their own time lines. We do announce them, we would expect to continue announcements over the coming month and months and over the next year.
Al: Ok! And with just to clarify and so with regard to China? Wefre expected to be filing shortly and thatfs just for oral?
Rick: Yah, the plan was to lead with oral, to make it nice and clean and once thatfs filed to follow it with the urine filing.
Al: Ok! So, shortly, I mean you know, obviously then before the end of the year?
Rick: Oh, absolutely!
Al: Ok! Alright and then, secondly, for whoever would be appropriate to comment, maybe Roger; what is the expected time frame when youfd be able to hire a new CEO? And what is the background or qualifications you would expect that person to possess?
Roger: Good question. The Board, when it met to discuss the interim replacement for Dr. George, the prediction was minimum 3 months, potential maximum 6 months. Minimum pretty much determined by what it takes to set down the terms of reference and description of the job and so forth and actually going out and recruiting a head hunter to find the right pool of candidates. A maximum 6 months because clearly someone of sufficient seniority and expertise is going to take some time to make an exit from their current employer. We hope itfs going to be nearer the 3 month mark, but I think we should be prepared for a longer period of time, if necessary. But, Dr. George has set out a vision for the Company and a set of goals and we will continue to drive the business in those directions and Ifm very confident that on this interim basis with the current management team we still have in place and with the support of Dr. George and Van Maanen in support and advisory roles, that we would keep it going and continue to do well until such time as the new CEO is in place.
Al: And that person would have, what a, youfd expect sort of an executive with another diagnostics firm?
Roger: I think the most likely candidate first up to bat would be an executive from a diagnostics firm; but I think potentially from the wider pharmaceuticals industry. And we would certainly be looking for somebody with international experience as our markets begin to open up. But also, I think it will need a candidate with considerable business acumen. Being CEO of a growing company like Calypte is becoming is going to require a vision and some expertise I think beyond just a mid-level manager. This has to be somebody serious and somebody respected within the industry.
Modorator: And Sir we have a question from the line of Linda Bruzzone, private investor.
Linda: Hello! My namefs Linda Bruzzone and I have a question about sales. Can you tell me in what countries what products are being sold and is rapid testing sold to these countries?
Roger: Ifm sorry; Rick would you like to take this?
Rick: Sure, Ifll give it my best! Today the sales that we have that will be on going are primarily with the Incidence Test which is one of our newer products that we developed with the help of the CDC. Thatfs being sold around the world. It started, I guess the end of last year and itfs, I wouldnft say itfs huge yet but itfs doubling virtually every quarter. The rapid tests wefve gotten approval in a couple of the smaller African companies but Ifd say no real substantial business there, some of the distributors have made their initial stocking orders that are starting to talk to their customers. So I think itfs; if you look at the pattern of the Incidence Test as things start slowly and gain momentum; I think wefre expecting that same pattern in the Rapid Test. We have them in inventory and wefre starting to sell them but really just in; think of them in marketing quantities at this time.
Linda: My second question is – can you tell me if there is any intellectual property that was picked up as a result of the acquisition of the China plant?
Roger: Could I just ask Ted Gwen to respond to that?
Ted: Yes, Dr. George had previously announced that the reason we werenft introducing the Blood Rapid Test in China was that, as part of that acquisition came with it an approved Blood Rapid Test already from the previous owner of that plant. So, we are picking up that and some other products in that acquisition.
Linda: Is there anyway you can tell us what those other products are? Are they strictly HIV? Are for testing of other infectious disease?
Ted: Theyfre primarily other; I mean; products for testing for other diseases, diagnostic tests. You know we havenft put a lot of focus on those since those arenft our primary focus. But we did pick them up in that process.
Linda: Is there any production of sales in China at this time with those products?
Ted: The only production in China is developing pilot lots and teaching the different people introduced to into manufacturing the product. We canft sell product in China till itfs approved. And once the SFDA application is approved then we can start our sales.
Modorator: And Sir, we have a question from the line of Steve Shedd private investor.
Steve: Yes, hello! I have a question about your news release; it stated that you were going to gpush forward the initiatives by Dr. George.h Could you just enumerate some of those?
Roger: I think first and foremost as part of restructuring that Dr. George led, where we have essentially sold off our Rockville plant. Dr. George has moved the focus, of course, away from the traditional blood diagnostics towards urine and oral. But he has also moved the Company from being a US based company to, I believe now a global company. As we move towards China; manufacturing in China and begin to look at the Russian, Indian markets, African markets, Middle Eastern markets and it is that international focus that Dr. George has brought to the Company. As well as developing new technologies of other various diagnostic tests, some of which are in the very early stages.
Steve: Yes, he mentioned the STD tests that would be coming in the future. Is that still on the plate there?
Roger: That work is still very much underway and is still very much in the pipeline for development and commercialization, although, Ifm simply not in the position to give you any indication as to when.
Steve: Can you shed some light on your statement, talking about the gpotential business strategiesh fro the news release?
Roger: The gpotential future business strategies.h I think wefre not in a position to do that just yet. I have, as I say, only been here a few days now and one of the things Ifm doing is taking an overall assessment of the Company itself. Overall financial performance and overall technical performance and against that I think we will set out what our short term objectives are going to be. I suspect those short term objectives are going to be exactly the same short term objectives as the Board and Dr. George had laid out. But in the longer term I think we need to look very carefully at our approach and our marketing approach to some of the markets wefve identified thus far, and how we can expedite the commercialization of our products for those particular markets. So, there could be some re-focusing of our overall marketing strategy in some of those countries. But, too early to say and too early to set out exactly what that long term strategy is going to be.
Steve: Ok! Ifd like to switch to the Incidence Test. The test was estimated that the potential would be around 5 to 10 million dollars per year and I wanted to know if that is factoring in the new DBS and the Ani Diagnostic/Incidence Test, do you know?
Roger: Ifll have to turn over I think that to Ted Gwen, to my left here.
Ted: Yes, both of those factor into that. The potential for the Ani platform Rapid Incidence Test is still developing, we are continuing to work on that. The current Incidence Test is growing beyond our expectations at this point and doing quite well. Itfs not achieved critical mass yet but it continues to grow. So, yes those are factoring into that estimate.
Roger: Rick, would you have anything to add to that?
Rick: The only comment I would make is that we really derived our estimates in discussions with the CDC and their plans for monitoring AIDS around the world and the things that they were going to require from the various countries. And so, you know whether itfs a rapid test or the current Incidence Test the fact of the matter is that they have a certain expectation in terms of number of tests. And so, just to re-affirm what Ted said whether itfs ultimately a rapid test or the current test I think the unit numbers are going to stay, are going to achieve about the same level, because of the demand.
Steve: Ok! I have a question the three disputed samples in China. Can you shed some light on that?
Roger: We have with us Chris Kafka, who is our Executive Director for China Operations, Chris would you comment please?
Chris: The disputed samples in China, we have one opinion about the true status of the samples in question. The agency who has been working has another opinion and but ultimately we hired them to do the study for us and wefre going to have to go with their view about the status of these samples. Itfs just that therefs no point arguing that with them.
Steve: Ok! Do you still see the Urine Test as out of the expedited SFDA review?
Chris: Yes, even with the disputed samples the performance of the assay above the cutoff parameter that wefve been told is required for the expedited review.
Steve: Letfs see, as far as selling in China; manufactured in China, Ifm sorry, manufactured in China and sold to other countries, is that something that you are planning on doing?
Chris: Yes, absolutely!
Steve: Ok! And would those products perhaps, after FDA approval, be sold here in the States?
Chris: Currently we have no plan to bring the current generation of products that will be produced in China into the United States. That is not to say that we donft have any intent to do so in the future with some products that might be currently under development.
Steve: Between the two plants, you have one in Thailand and one in China, the one in China is less expensive to manufacture product?
Chris: It could be less expensive; we for the foreseeable future will maintain both manufacturing facilities because itfs always good to have a backup.
Steve: In terms of anything shipped from China to another country, would the Marr Group, the marketing arm of the Marr Group also share of the profits of that?
Chris: We will maintain, for business done outside of China we will maintain an arms length relationship with the Marr Group.
Steve: Turning to India, I have a question about the Incidence Test there. Dr. George mentioned that the DCAI may wave the registration requirements, is that something thatfs been done?
Roger: Could I turn to Ted Gwen please, Ted go ahead!
Ted: Yah, DCAI have, came back to us this last week and said that we still need to file the registration, itfs been done and we should hear back from them in the near future. Itfs more a formality than anything else. Theyfre using the test in very limited quantities and we have no indication that they are not going to accept it. They are very positive about it and as a matter of fact Dick Van Maanen is going to be in India in the coming weeks to meet with the DCAI and other government officials to conclude all of that registration process.
Steve: And about the rapid clinicals in India, is there anything happening there?
Ted: At this point – no! We do have plans in the future for the rapid clinicals in India, as we speak today – no!
Steve: Ok! Two other questions, onefs on financing. When do see a break-even on sales and the burn rate?
Ted: Yah, thatfs probably going to be toward the 3rd, 4th quarter of next year. Depends on how soon we can get these products registered in these countries and start making sales. BED continues to ramp, and depending on the growth rate of BED; our burn rate currently is in the, as wefve reported before in the $500,000 a month range, which is down considerably from the $1.2 million last year. And so, restructuring is continuing to reduce that cost.
Steve: Now, the Incidence sale, the profit on those, is that, can you give us an idea on what that might be?
Ted: Incidence sales, itfs a very high margin product and we hope to continue that. The ramp on that has done quite nicely and wefre hoping that we can achieve a break even on that product in terms of sales again, toward the end of next year. The others depend on how fast the rapid tests get approved and we can start making sales into the countries wefve got approvals. BED is less of a regulatory issue in many countries because itfs not a diagnostic product; itfs for surveillance use only.
Moderator: And Sir, we have a question from the line of Robert Dode with United Capital.
Robert: Yes, can you give us any more detailed background on the Marr Group? Obviously Ifve searched but I really donft understand a great deal about what they do and where their backing comes from.
Roger: I will give you as much information as available in the public domain. Marr is a private financial group. It is owned predominately by the Safin family. Safin family are a very well known group within the Russian Federation, although the members of the Safin family that run the Marr Group are based in the United Kingdom and are British citizens. I have known the Marr Group; the principals of the Marr Group for I would suppose close to 14 or 15 years. It is a family run group, a family trust, if you will? Father, son daughter and I think, brother and I am personally involved with the Marr Group in several other companies. Very well regarded group in Russian Federation and in the United Kingdom, they are a financial investor and quite a formidable group. They have invested quite widely across Europe and the United States, Telecommunications and technology, the sugar industry in Europe and indeed theyfve won awards for the quality of their plants. Their also infrastructure investors as well as real estate investors and I think the background of the family is in the oil industry. And certainly in Wavecrest, my own Company where Ifm a sizable investor, they have been an investor for the past four years.
Robert: And secondly, you mentioned that Calypte has sufficient funds for an undefined interval. Do you foresee, having been Chairman since 2004 that the Company has sufficient funds to carry it to the point where itfs going to be break-even on sales? Or no?
Roger: I think as Chairman of the Board youfve rightly point out Ifve been there some time. I have certainly seen the viability of the Company improve over those months that Ifve been with the Company but we have a sufficient amount of cash plus sufficient funding mechanism in place, such that we could fund the business through to break-even.
Robert: And what is the funding mechanism in place?
Roger: We have a debt facility in place with the Marr Group.
Robert: Does that involve more equity or is that just straight debt?
Ted: Itfs just straight debt.
Robert: Alright thank you very, very much. And Mr. Gale youfre going to be; I take it your certainly going to be based elsewhere, youfre not going to be based in Portland.
Roger: No, to the best of my ability I will be based in Portland for the foreseeable future. That may not be 100% of the time but there will be some related travel with the Company and to the extent possible I will be based here in Portland with the management team.
Robert: Well, to the extent youfve spent time in Ireland, then youfll feel very much at home with the rain.
Roger: (Laughter) I donft know how to answer that because Ireland is just a little bit wetter than England, but thank you very much!
Moderator: And Sir, we have a question from the line of Ron Hoover, with Hoover Construction.
Ron: Yes, thank you! I just want to ask, in the next foreseeable, say three years out what kind of revenue do you anticipate the Company having? Say in the end of 2008 or fiscal year 2009.
Roger: I myself wish I could give you an answer but I think wefve got some work to do on the business plan to be able to answer that one; ghow long is a piece of string.h But, Ted, CFO to my left here, perhaps he can give us a part answer to that.
Ted: The thing that we have, the most difficult part of doing any kind of predictions is, we donft control the approval process in many of these countries. We work very diligently with the government agencies in the approval process and in doing clinical trials. And how rapid we get those approvals and can get in to start selling tests; thatfs the difficult part of making any kind of prediction. We do expect the BED product to continue to ramp up, itfs accepted quite widely. Wefre selling it in Africa and India and US and South America and the Caribbean and continue to see that grow.
Roger: If I could just add to what Ted has said. One of the things we have to do in the near future, as I said earlier is to settle down now and develop a set of short term, long term objectives for the Company, both operational and financial. And those financial objectives will be forecasts of course, but against those we will be setting out strategies by which we aim to achieve those objectives. I still have a lot to learn about this industry and the vagaries of planning too much too far ahead when youfre so reliant on governments and government approvals and funding by funding by other governments but I think wefre going to give it a really good go, so that wefve got some targets to aim for in the future. But, a good question.
Moderator: And Sir, we have a question from the line of Frank Cobb private investor.
Frank: Yes, thank you! I wondered in a time of approvals and possibly orders are imminent, I wonder if you could be more specific as to why Dr. George actually resigned at this point?
Roger: Thank you! Dr. George chose to leave the Company and he is leaving on good terms with the Company. Indeed as wefve said, hefs going to stay on as an advisor. The most I can really say is that, I think Dr. George is leaving for philosophical reasons and thatfs probably is the most I can say. His resignation certainly didnft give any reasons and I would be somewhat loath to inter into the conjecture as to why he did. But hefs held in incredibly high regard here in the Company and indeed many of our managers senior and mid level were recruited by Dr. George. So, at this time, Ifm sorry Ifm just not able to give you more flavor as to the reasons why.
Frank: Just one short question. I just wondered if the leadership would consider selling the Company or at a time when therefs been a lot of attention on AIDS testing and so on?
Roger: I think the management and the Board would certainly not discount consideration of a sale, because after all this is a business. But I think it is certainly premature to bring that in the middle of the table. I think what I have seen in the last three days is actually that the management is very excited about building and growing the business on whatfs been achieved so far. From someone whofs not familiar with the scientific community I would say that the bulk of the science, the difficult science has now been done. Wefre now in the stage of commercialization of the science and entering the sales process itself. So, I do believe the Company has considerable value still to come. Now that of course is a forward looking statement but itfs what I firmly believe. I am a business man first and foremost.
Moderator: And Sir, we have a question from the line of Mark Chaffin with Doresett Management.
Mark: My question is: Dr. George had been granted a fairly substantial option package and I was wondering if there was any severance agreement here. If he resigned, one would think that he resigned and is leaving his options on the table, his subscription would be canceled.
Roger: I would need to revert here to Rick Brounstien. Rick would you kindly field that one?
Rick: Sure, yah he resigned so there is no special severance package that went into affect. His options were vested, today theyfre not at market price but he will have a period of time before they would expire that if things moved up he would have a chance to exercise them before they would go away.
Moderator: And ladies and gentlemen this concludes the Q&A portion of todayfs event. Sir, back over to you for any closing remarks!
Roger: Thank you very much indeed ladies and gentlemen we do appreciate you phoning in to us this morning. Thank you very much for your questions. I do hope wefve given you sufficient answer to make you feel that the business continues to grow and we continue to move forward despite this hiatus of Dr. Georgefs resignation. We do look forward to talking to you again and as I and my colleagues have said in mid November wefll be coming back to you with a more formal presentation of the financial and operational results of the Company, So, thank you very much indeed !
10/14/05, 11:00 am ET.
Good morning and thank you for joining us today on this Call. I am Roger Gale, the Chairman and interim CEO of Calypte Biomedical. I was appointed interim CEO by the board of directors on October 5, 2005 pursuant to section 5.6 of the Companyfs bylaws. I have served as Chairman of the board since November 2004. Since my election as Chairman of the Company last year I have worked with the board and senior management on the initiatives to restructure the Company. These initiatives where undertaken to increase efficiency and reduce the cash burn rate in the short term. While more clearly identifying and implementing its longer term objectives and strategies. All of us associating with Calypte have been and continue to work diligently with these goals in mind. On the resignation of Dr. George as President CEO, I asked for and was granted a leave of absence as Executive Chairman of the board of directors of Wavecrest Group Enterprises so that I could work with Calypte to ensure that the direction and momentum developed under Dr. Georgefs leadership was maintained for the period of time that we require to search for and appoint a new President and CEO for the Company. By way of background, Wavecrest is a UK based international telecommunications service provider. I was a co-founder and one of the initial investors in the Company. Over the past four years, since its inception it has grown from $0 to $27 million dollars per month in revenues. With annual 2005 revenues expected to be around $300 million dollars. The Company is now approaching financial viability. As you know the Marr Group is also a major shareholder in Wavecrest. What that means to Calypte is that a major shareholder believes strongly in the Calypte story. So much so that Ifve been able to make this choice to take a more active roll in the Company as we take Calypte forward. And Ifm not shy about telling you that I have considerable experience in conducting the type international business that we see in Calyptefs future. Additionally Ifm a member of the Board of Directors and of the Audit Committee of Mechel Group an integrated coal and steel group based in Moscow, Russia. Mechel is listed on the New York Stock Exchange. I take very seriously my fiduciary responsibilities as a board member of that Company and indeed equally in Calypte. As you know, we recently announced the resignations of Dr. Richard George and Dick Van Maanen our Vice President - Operations and International development. Dr. George will be staying with us for the foreseeable future as a scientific advisor and in this capacity he will be devoting much of his time to the science supporting the development and evaluations of our new products and working closely with the CDC and other government agencies in the US and around the world. We are pleased that he will continue to have access, we are pleased sorry, that we will continue to have access to his scientific expertise in this advisory capacity. Dick Van Maanen will also stay on as a consultant for a period of time.
Let me take this opportunity to provide you with a couple of operational updates. In China, as we have previously advised, we expect to file shortly for SFDA approval of our Oral Fluid Rapid Test. And we ask you to stay tuned for news of the actual filings. We believe it will still qualify for the fast track ggreen passh which may still take approximately 90 days from the date of submission to approval. We have just dispatched our Chief Science Officer, Dr. Ron Mink to China to wrap up the filings. We believe we are close to concluding the sale of our legacy business products to Maxim. This transaction has been complicated by fact the FDA regulated Rockville facility and the IP licenses related to the products produced there have all been transferred as part of the commercial transaction. The facility has been running smoothly for the past several months under Maximfs management. We plan to provide more detail regarding the Companyfs operational financial status when we release the 3rd quarter 2005 results in mid November. For now however, let me reiterate that we believe that we have access to sufficient resources to continue our operations as we continue to execute on our defined business plans. As I said in the beginning of our presentation, we continue to work very hard to achieve our targets and execute our strategies. I realize we have much more to do. We will continue to update you as things progress. Thank you for your participation in todayfs call and this concludes my formal remarks and I think we are now ready to open this up for questions. So, operator kindly go ahead and Tim return to you, thank you.
Q&A Session
Sir, we have a question from the line of Tom DeHooty with (unknown word) Asset Management.
Tom: Good morning! Can you give us a little more background as to why all these management places took place at the same time?
Roger: Thank you, Roger Gale here. I think first of all we must separate the changes in two parts. The first was, the first set of changes were related to the restructuring. Ted Gwen who had been with us as an officer in the financial group was appointed CFO as a part of that restructuring. Also part of that restructuring, which Rick Brounstien, who was CFO, as we moved up to Portland, Rick decided not to move up to Portland with the Company. But Rick has agreed to stay on as Executive Vice President. So those are two of the changes. The resignation of Dr. George was an entirely separate matter. At the time of Dr. Georgefs resignation we also received the resignation of Dr., sorry, Dick Van Maanen. The two I suppose were related in the sense that, Dick Van Maanen whofd been with the Company twelve and a half years clearly felt that it was an appropriate time for him to resign also. However, as we have said both Dr. George and Mr. Van Maanen will be remaining with the Company for the foreseeable future as advisors to the Company; respectively on the area of science advisor and on the basis of marketing consultant.
Tom: And what will Rick Brounstien's functional responsibilities be going forward?
Roger: Rick Brounstien as Executive Vice President going forward, he will be advising the Company in all aspects of the capital markets, aspects related to any requirements for fund raising, any aspects related to investor relations and also providing guidance to me as interim CEO and the new CEO which we will appoint in terms of the overall structure of the Company. He will be in the longer term, we hope, our link to the historical knowledge of the Company. And I am absolutely delighted hefs staying on with us even thought he has not moved up to Portland to join us.
Tom: And one last management question. Are you anticipating bringing any other additional management talent in besides the new CEO?
Roger: Good question! I think Ifve only been on the job, just my third day and Ifm just getting my arms around the Company itself. As Chairman of the Company of course, my responsibilities and depth of understanding is at one particular level. To run the Company is another level of understanding. I think we will have to look at this very closely. It is certainly part and parcel of the overall restructuring of the Company. But potentially, Ifm not making a commitment here, but potentially the Company may need a Chief Operating Officer to support the Chief Executive Officer. The reason I say this is the Company is beginning to grow in terms of outreach into the developing world, in the emerging world and the day to day responsibilities will soon be growing to such an extent that no single CEO will be able to keep his arms around all the operational developments. So, I think thatfs where initially I do see a need, perhaps for some additional management expertise.
Moderator: Sir our next question is from the line of Al Kildony with SF Capital.
Al: Good morning! I wonder if you could provide a little more color regarding the time frame for various regulatory time lines and different countries. I know youfve provided some guidance for China, anything else you can say about progress being made in African nations and other nations in South East Asia that could be of significance to Calypte?
Roger: Could I kindly ask Rick Brounstien if he will field that question please?
Rick: Well Al, hi! Itfs a tough question. Wefll probably try to do a much more complete assessment in a couple weeks when we get on the quarter and conference call. You guys have been seeing various announcements as the, as we get approvals in various countries or as we sign up distributors in that; there are probably, oh I would say 20 or so countries, many in Africa some in South East Asia that are targeted over the next 12 months. A lot of them tied into the PEPFAR money, the US funds supporting some of these poorer countries. All I can do is say, gstay tuned as these things break. And obviously they break on their own time lines. We do announce them, we would expect to continue announcements over the coming month and months and over the next year.
Al: Ok! And with just to clarify and so with regard to China? Wefre expected to be filing shortly and thatfs just for oral?
Rick: Yah, the plan was to lead with oral, to make it nice and clean and once thatfs filed to follow it with the urine filing.
Al: Ok! So, shortly, I mean you know, obviously then before the end of the year?
Rick: Oh, absolutely!
Al: Ok! Alright and then, secondly, for whoever would be appropriate to comment, maybe Roger; what is the expected time frame when youfd be able to hire a new CEO? And what is the background or qualifications you would expect that person to possess?
Roger: Good question. The Board, when it met to discuss the interim replacement for Dr. George, the prediction was minimum 3 months, potential maximum 6 months. Minimum pretty much determined by what it takes to set down the terms of reference and description of the job and so forth and actually going out and recruiting a head hunter to find the right pool of candidates. A maximum 6 months because clearly someone of sufficient seniority and expertise is going to take some time to make an exit from their current employer. We hope itfs going to be nearer the 3 month mark, but I think we should be prepared for a longer period of time, if necessary. But, Dr. George has set out a vision for the Company and a set of goals and we will continue to drive the business in those directions and Ifm very confident that on this interim basis with the current management team we still have in place and with the support of Dr. George and Van Maanen in support and advisory roles, that we would keep it going and continue to do well until such time as the new CEO is in place.
Al: And that person would have, what a, youfd expect sort of an executive with another diagnostics firm?
Roger: I think the most likely candidate first up to bat would be an executive from a diagnostics firm; but I think potentially from the wider pharmaceuticals industry. And we would certainly be looking for somebody with international experience as our markets begin to open up. But also, I think it will need a candidate with considerable business acumen. Being CEO of a growing company like Calypte is becoming is going to require a vision and some expertise I think beyond just a mid-level manager. This has to be somebody serious and somebody respected within the industry.
Modorator: And Sir we have a question from the line of Linda Bruzzone, private investor.
Linda: Hello! My namefs Linda Bruzzone and I have a question about sales. Can you tell me in what countries what products are being sold and is rapid testing sold to these countries?
Roger: Ifm sorry; Rick would you like to take this?
Rick: Sure, Ifll give it my best! Today the sales that we have that will be on going are primarily with the Incidence Test which is one of our newer products that we developed with the help of the CDC. Thatfs being sold around the world. It started, I guess the end of last year and itfs, I wouldnft say itfs huge yet but itfs doubling virtually every quarter. The rapid tests wefve gotten approval in a couple of the smaller African companies but Ifd say no real substantial business there, some of the distributors have made their initial stocking orders that are starting to talk to their customers. So I think itfs; if you look at the pattern of the Incidence Test as things start slowly and gain momentum; I think wefre expecting that same pattern in the Rapid Test. We have them in inventory and wefre starting to sell them but really just in; think of them in marketing quantities at this time.
Linda: My second question is – can you tell me if there is any intellectual property that was picked up as a result of the acquisition of the China plant?
Roger: Could I just ask Ted Gwen to respond to that?
Ted: Yes, Dr. George had previously announced that the reason we werenft introducing the Blood Rapid Test in China was that, as part of that acquisition came with it an approved Blood Rapid Test already from the previous owner of that plant. So, we are picking up that and some other products in that acquisition.
Linda: Is there anyway you can tell us what those other products are? Are they strictly HIV? Are for testing of other infectious disease?
Ted: Theyfre primarily other; I mean; products for testing for other diseases, diagnostic tests. You know we havenft put a lot of focus on those since those arenft our primary focus. But we did pick them up in that process.
Linda: Is there any production of sales in China at this time with those products?
Ted: The only production in China is developing pilot lots and teaching the different people introduced to into manufacturing the product. We canft sell product in China till itfs approved. And once the SFDA application is approved then we can start our sales.
Modorator: And Sir, we have a question from the line of Steve Shedd private investor.
Steve: Yes, hello! I have a question about your news release; it stated that you were going to gpush forward the initiatives by Dr. George.h Could you just enumerate some of those?
Roger: I think first and foremost as part of restructuring that Dr. George led, where we have essentially sold off our Rockville plant. Dr. George has moved the focus, of course, away from the traditional blood diagnostics towards urine and oral. But he has also moved the Company from being a US based company to, I believe now a global company. As we move towards China; manufacturing in China and begin to look at the Russian, Indian markets, African markets, Middle Eastern markets and it is that international focus that Dr. George has brought to the Company. As well as developing new technologies of other various diagnostic tests, some of which are in the very early stages.
Steve: Yes, he mentioned the STD tests that would be coming in the future. Is that still on the plate there?
Roger: That work is still very much underway and is still very much in the pipeline for development and commercialization, although, Ifm simply not in the position to give you any indication as to when.
Steve: Can you shed some light on your statement, talking about the gpotential business strategiesh fro the news release?
Roger: The gpotential future business strategies.h I think wefre not in a position to do that just yet. I have, as I say, only been here a few days now and one of the things Ifm doing is taking an overall assessment of the Company itself. Overall financial performance and overall technical performance and against that I think we will set out what our short term objectives are going to be. I suspect those short term objectives are going to be exactly the same short term objectives as the Board and Dr. George had laid out. But in the longer term I think we need to look very carefully at our approach and our marketing approach to some of the markets wefve identified thus far, and how we can expedite the commercialization of our products for those particular markets. So, there could be some re-focusing of our overall marketing strategy in some of those countries. But, too early to say and too early to set out exactly what that long term strategy is going to be.
Steve: Ok! Ifd like to switch to the Incidence Test. The test was estimated that the potential would be around 5 to 10 million dollars per year and I wanted to know if that is factoring in the new DBS and the Ani Diagnostic/Incidence Test, do you know?
Roger: Ifll have to turn over I think that to Ted Gwen, to my left here.
Ted: Yes, both of those factor into that. The potential for the Ani platform Rapid Incidence Test is still developing, we are continuing to work on that. The current Incidence Test is growing beyond our expectations at this point and doing quite well. Itfs not achieved critical mass yet but it continues to grow. So, yes those are factoring into that estimate.
Roger: Rick, would you have anything to add to that?
Rick: The only comment I would make is that we really derived our estimates in discussions with the CDC and their plans for monitoring AIDS around the world and the things that they were going to require from the various countries. And so, you know whether itfs a rapid test or the current Incidence Test the fact of the matter is that they have a certain expectation in terms of number of tests. And so, just to re-affirm what Ted said whether itfs ultimately a rapid test or the current test I think the unit numbers are going to stay, are going to achieve about the same level, because of the demand.
Steve: Ok! I have a question the three disputed samples in China. Can you shed some light on that?
Roger: We have with us Chris Kafka, who is our Executive Director for China Operations, Chris would you comment please?
Chris: The disputed samples in China, we have one opinion about the true status of the samples in question. The agency who has been working has another opinion and but ultimately we hired them to do the study for us and wefre going to have to go with their view about the status of these samples. Itfs just that therefs no point arguing that with them.
Steve: Ok! Do you still see the Urine Test as out of the expedited SFDA review?
Chris: Yes, even with the disputed samples the performance of the assay above the cutoff parameter that wefve been told is required for the expedited review.
Steve: Letfs see, as far as selling in China; manufactured in China, Ifm sorry, manufactured in China and sold to other countries, is that something that you are planning on doing?
Chris: Yes, absolutely!
Steve: Ok! And would those products perhaps, after FDA approval, be sold here in the States?
Chris: Currently we have no plan to bring the current generation of products that will be produced in China into the United States. That is not to say that we donft have any intent to do so in the future with some products that might be currently under development.
Steve: Between the two plants, you have one in Thailand and one in China, the one in China is less expensive to manufacture product?
Chris: It could be less expensive; we for the foreseeable future will maintain both manufacturing facilities because itfs always good to have a backup.
Steve: In terms of anything shipped from China to another country, would the Marr Group, the marketing arm of the Marr Group also share of the profits of that?
Chris: We will maintain, for business done outside of China we will maintain an arms length relationship with the Marr Group.
Steve: Turning to India, I have a question about the Incidence Test there. Dr. George mentioned that the DCAI may wave the registration requirements, is that something thatfs been done?
Roger: Could I turn to Ted Gwen please, Ted go ahead!
Ted: Yah, DCAI have, came back to us this last week and said that we still need to file the registration, itfs been done and we should hear back from them in the near future. Itfs more a formality than anything else. Theyfre using the test in very limited quantities and we have no indication that they are not going to accept it. They are very positive about it and as a matter of fact Dick Van Maanen is going to be in India in the coming weeks to meet with the DCAI and other government officials to conclude all of that registration process.
Steve: And about the rapid clinicals in India, is there anything happening there?
Ted: At this point – no! We do have plans in the future for the rapid clinicals in India, as we speak today – no!
Steve: Ok! Two other questions, onefs on financing. When do see a break-even on sales and the burn rate?
Ted: Yah, thatfs probably going to be toward the 3rd, 4th quarter of next year. Depends on how soon we can get these products registered in these countries and start making sales. BED continues to ramp, and depending on the growth rate of BED; our burn rate currently is in the, as wefve reported before in the $500,000 a month range, which is down considerably from the $1.2 million last year. And so, restructuring is continuing to reduce that cost.
Steve: Now, the Incidence sale, the profit on those, is that, can you give us an idea on what that might be?
Ted: Incidence sales, itfs a very high margin product and we hope to continue that. The ramp on that has done quite nicely and wefre hoping that we can achieve a break even on that product in terms of sales again, toward the end of next year. The others depend on how fast the rapid tests get approved and we can start making sales into the countries wefve got approvals. BED is less of a regulatory issue in many countries because itfs not a diagnostic product; itfs for surveillance use only.
Moderator: And Sir, we have a question from the line of Robert Dode with United Capital.
Robert: Yes, can you give us any more detailed background on the Marr Group? Obviously Ifve searched but I really donft understand a great deal about what they do and where their backing comes from.
Roger: I will give you as much information as available in the public domain. Marr is a private financial group. It is owned predominately by the Safin family. Safin family are a very well known group within the Russian Federation, although the members of the Safin family that run the Marr Group are based in the United Kingdom and are British citizens. I have known the Marr Group; the principals of the Marr Group for I would suppose close to 14 or 15 years. It is a family run group, a family trust, if you will? Father, son daughter and I think, brother and I am personally involved with the Marr Group in several other companies. Very well regarded group in Russian Federation and in the United Kingdom, they are a financial investor and quite a formidable group. They have invested quite widely across Europe and the United States, Telecommunications and technology, the sugar industry in Europe and indeed theyfve won awards for the quality of their plants. Their also infrastructure investors as well as real estate investors and I think the background of the family is in the oil industry. And certainly in Wavecrest, my own Company where Ifm a sizable investor, they have been an investor for the past four years.
Robert: And secondly, you mentioned that Calypte has sufficient funds for an undefined interval. Do you foresee, having been Chairman since 2004 that the Company has sufficient funds to carry it to the point where itfs going to be break-even on sales? Or no?
Roger: I think as Chairman of the Board youfve rightly point out Ifve been there some time. I have certainly seen the viability of the Company improve over those months that Ifve been with the Company but we have a sufficient amount of cash plus sufficient funding mechanism in place, such that we could fund the business through to break-even.
Robert: And what is the funding mechanism in place?
Roger: We have a debt facility in place with the Marr Group.
Robert: Does that involve more equity or is that just straight debt?
Ted: Itfs just straight debt.
Robert: Alright thank you very, very much. And Mr. Gale youfre going to be; I take it your certainly going to be based elsewhere, youfre not going to be based in Portland.
Roger: No, to the best of my ability I will be based in Portland for the foreseeable future. That may not be 100% of the time but there will be some related travel with the Company and to the extent possible I will be based here in Portland with the management team.
Robert: Well, to the extent youfve spent time in Ireland, then youfll feel very much at home with the rain.
Roger: (Laughter) I donft know how to answer that because Ireland is just a little bit wetter than England, but thank you very much!
Moderator: And Sir, we have a question from the line of Ron Hoover, with Hoover Construction.
Ron: Yes, thank you! I just want to ask, in the next foreseeable, say three years out what kind of revenue do you anticipate the Company having? Say in the end of 2008 or fiscal year 2009.
Roger: I myself wish I could give you an answer but I think wefve got some work to do on the business plan to be able to answer that one; ghow long is a piece of string.h But, Ted, CFO to my left here, perhaps he can give us a part answer to that.
Ted: The thing that we have, the most difficult part of doing any kind of predictions is, we donft control the approval process in many of these countries. We work very diligently with the government agencies in the approval process and in doing clinical trials. And how rapid we get those approvals and can get in to start selling tests; thatfs the difficult part of making any kind of prediction. We do expect the BED product to continue to ramp up, itfs accepted quite widely. Wefre selling it in Africa and India and US and South America and the Caribbean and continue to see that grow.
Roger: If I could just add to what Ted has said. One of the things we have to do in the near future, as I said earlier is to settle down now and develop a set of short term, long term objectives for the Company, both operational and financial. And those financial objectives will be forecasts of course, but against those we will be setting out strategies by which we aim to achieve those objectives. I still have a lot to learn about this industry and the vagaries of planning too much too far ahead when youfre so reliant on governments and government approvals and funding by funding by other governments but I think wefre going to give it a really good go, so that wefve got some targets to aim for in the future. But, a good question.
Moderator: And Sir, we have a question from the line of Frank Cobb private investor.
Frank: Yes, thank you! I wondered in a time of approvals and possibly orders are imminent, I wonder if you could be more specific as to why Dr. George actually resigned at this point?
Roger: Thank you! Dr. George chose to leave the Company and he is leaving on good terms with the Company. Indeed as wefve said, hefs going to stay on as an advisor. The most I can really say is that, I think Dr. George is leaving for philosophical reasons and thatfs probably is the most I can say. His resignation certainly didnft give any reasons and I would be somewhat loath to inter into the conjecture as to why he did. But hefs held in incredibly high regard here in the Company and indeed many of our managers senior and mid level were recruited by Dr. George. So, at this time, Ifm sorry Ifm just not able to give you more flavor as to the reasons why.
Frank: Just one short question. I just wondered if the leadership would consider selling the Company or at a time when therefs been a lot of attention on AIDS testing and so on?
Roger: I think the management and the Board would certainly not discount consideration of a sale, because after all this is a business. But I think it is certainly premature to bring that in the middle of the table. I think what I have seen in the last three days is actually that the management is very excited about building and growing the business on whatfs been achieved so far. From someone whofs not familiar with the scientific community I would say that the bulk of the science, the difficult science has now been done. Wefre now in the stage of commercialization of the science and entering the sales process itself. So, I do believe the Company has considerable value still to come. Now that of course is a forward looking statement but itfs what I firmly believe. I am a business man first and foremost.
Moderator: And Sir, we have a question from the line of Mark Chaffin with Doresett Management.
Mark: My question is: Dr. George had been granted a fairly substantial option package and I was wondering if there was any severance agreement here. If he resigned, one would think that he resigned and is leaving his options on the table, his subscription would be canceled.
Roger: I would need to revert here to Rick Brounstien. Rick would you kindly field that one?
Rick: Sure, yah he resigned so there is no special severance package that went into affect. His options were vested, today theyfre not at market price but he will have a period of time before they would expire that if things moved up he would have a chance to exercise them before they would go away.
Moderator: And ladies and gentlemen this concludes the Q&A portion of todayfs event. Sir, back over to you for any closing remarks!
Roger: Thank you very much indeed ladies and gentlemen we do appreciate you phoning in to us this morning. Thank you very much for your questions. I do hope wefve given you sufficient answer to make you feel that the business continues to grow and we continue to move forward despite this hiatus of Dr. Georgefs resignation. We do look forward to talking to you again and as I and my colleagues have said in mid November wefll be coming back to you with a more formal presentation of the financial and operational results of the Company, So, thank you very much indeed !
20.10.05 09:00
#5028
LuckyStrike
einfach mal lesen und cool bleiben
http://allafrica.com/stories/200510190607.html
20.10.05 19:31
#5029
Caly_stirbt_lang.
Löschung
Moderation
Zeitpunkt: 20.10.05 19:57
Aktion: Löschung des Beitrages
Kommentar: Regelverstoß
Zeitpunkt: 20.10.05 19:57
Aktion: Löschung des Beitrages
Kommentar: Regelverstoß
24.10.05 16:46
#5031
Abenteurer
Seit Jahren wird bei Caly auf Hoffnung gesetzt:
Hut ab, Ihr seit alle wirklich hart im Nehmen.
Viele Grüße Abenteurer
Viele Grüße Abenteurer
infolive! Aktuelle Nachrichten
24.10.05 17:41
#5032
Biomedi
Nun ja, China rechnet mit bis zu 10 Millionen
HIV Infizierten bis 2010 laut Reuters Bericht vor 1 Stunde. Da Calypte in China wohl als Hauptanbieter von HIV Tests auftreten wird, ist diese Hoffnung sicher nicht so unberechtigt!
24.10.05 17:44
#5033
Brokersince1994.
Ich bin ja gespannt wie alle gucken werden, wie
Calypte die Zulassung bekannt geben wird ind China..
; )
Gruß
C.O
Calypte die Zulassung bekannt geben wird ind China..
; )
Gruß
C.O
24.10.05 17:59
#5034
Franz_W
Es sieht so aus, als wenn die Kritiker
wieder Recht bekommen:
Time & Sales most recent next page
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14.11.05 14:25
#5036
Kade_I
i´m back from the Caribean Sea ....
Long and Strong ! Auf zwei starke letzte November-Wochen !!!!!!
Grüße
Grüße
14.11.05 17:23
#5038
Biomedi
Ja willkommen Kade. Wo warst Du?
Meinen Wintertrip soll doch Calypte finanzieren. Wie lange soll ich da noch warten? Es wird kalt hier!
15.11.05 15:53
#5039
Kade_I
Ja hallo Ihr,
war drei Wochen auf den Virgin-Islands.
Übrigens die ersten kleinen Rapid-Sales wurden getätigt !
http://phx.corporate-ir.net/...=irol-newsArticle&ID=782954&highlight=
"we began making limited international shipments of our rapid HIV-1/2 tests and generated a small amount of revenue from those sales during the third quarter. This marks an important milestone and we hope to be able to follow through with additional country approvals and international shipments."
Beste Grüße
Übrigens die ersten kleinen Rapid-Sales wurden getätigt !
http://phx.corporate-ir.net/...=irol-newsArticle&ID=782954&highlight=
"we began making limited international shipments of our rapid HIV-1/2 tests and generated a small amount of revenue from those sales during the third quarter. This marks an important milestone and we hope to be able to follow through with additional country approvals and international shipments."
Beste Grüße
15.11.05 16:43
#5040
Skydust
Auch Hallo...kommen hier in den letzten
letzten November 2 Wochen irgendwelche Zahlen..weiss einer was darüber?
Schon mal Danke sag, falls jemand was weiss!
Schon mal Danke sag, falls jemand was weiss!
17.11.05 13:10
#5042
Kade_I
Wie Calypte - sehr interessant !
Some of you might be interested in reading a study on VPHM. It's interesting because it resembles our situation. Before you read this take a look at a 5 month chart of VPHM.
ViroPharma (VPHM) is a biotech firm established eleven years ago to develop a cure for the common cold. The FDA rejected pleconaril (the company’s cure for the cold virus) in 2002 and was forced to reduce employee count from 435 to 35. They began looking for a product to sell as a revenue stream when Piper Jafray approached VPHM with the US rights to market Vancocin. Vancocin is used to fight a bacteria found in the colon called C. difficile. When ViroPharma noticed Vancocin sales were increasing each year since 2002, they bought the rights last November for $116 million. The market value of ViroPharma at that time was about $50 million. Seeing the opportunity to make financial gain over this boon, they raised the price for Vancocin three times for a total of 80%. Sales in 2005 are expected to grow to $120 million and the Company will be profitable for the first time in their eleven year history. The upward trend in the price changed dramatically in May of this year when the company announced 2005 first quarter net income of over $17 million compared to a net loss of $16.6 million for the same period in 2004. In six months the pps went from $1.67 to $24.36 with a market cap high of $1.4 billion. As sales continued to increase the company took important steps to reduce its debt by purchasing 2007 convertible notes and later completely eliminating its debt for 2009. Within 6 months it traded for a 52 week high on November 7th of $24.36. Along the way analysts also helped to lift the stock to its recent highs. On November 9th things began to change when the New York Times printed an article describing the possibility of competition introducing a generic version of the drug. The stock began to drop and the company held a CC under the pretense of discussing clinical results of a drug in development called HCV-796. During the CC investors queried management about the issue of generic drugs competing with Vancocin. Management assured investors that to market such a drug would take at least 4 years to complete, giving ViroPharma time to reap plenty of profits. Because ViroPharma is a one product company, bears have recently taken advantage of the threat of competition and moved in. The stock is continuing to drop and today it traded at $16.48.
While observing VPHM the thought occurred to me that Calypte might be positioned to profit similarly. Both are biotech companies having been in product development for years. Both are just beginning to sell products with huge upside potential. Each one has financed operations using equity and debt. Long term debt is significant – Calypte - $150 million, ViroPharma - $236 million. ViroPharma has an exclusive market; Calypte will have the only oral HIV assay in China. Each own products that can save lives and improve patient care. Up to this point conditions are very similar. What are the differences? ViroPharma has only one product (weakness), Calypte will have several (strength). ViroPharma has one market (weakness), Calypte - international and domestic sales (strength). ViroPharma’s O/S is 59 million (strength), Calypte’s is 181 million (weakness).
With just the possibility of $120 million in sales VPHM climbed to a market cap of $1.4 billion. That is an incredible stretch but we all know favorable market conditions produce these high numbers. Calypte’s price with a market cap of $1.4 billion would be $7.73 ps.
ViroPharma (VPHM) is a biotech firm established eleven years ago to develop a cure for the common cold. The FDA rejected pleconaril (the company’s cure for the cold virus) in 2002 and was forced to reduce employee count from 435 to 35. They began looking for a product to sell as a revenue stream when Piper Jafray approached VPHM with the US rights to market Vancocin. Vancocin is used to fight a bacteria found in the colon called C. difficile. When ViroPharma noticed Vancocin sales were increasing each year since 2002, they bought the rights last November for $116 million. The market value of ViroPharma at that time was about $50 million. Seeing the opportunity to make financial gain over this boon, they raised the price for Vancocin three times for a total of 80%. Sales in 2005 are expected to grow to $120 million and the Company will be profitable for the first time in their eleven year history. The upward trend in the price changed dramatically in May of this year when the company announced 2005 first quarter net income of over $17 million compared to a net loss of $16.6 million for the same period in 2004. In six months the pps went from $1.67 to $24.36 with a market cap high of $1.4 billion. As sales continued to increase the company took important steps to reduce its debt by purchasing 2007 convertible notes and later completely eliminating its debt for 2009. Within 6 months it traded for a 52 week high on November 7th of $24.36. Along the way analysts also helped to lift the stock to its recent highs. On November 9th things began to change when the New York Times printed an article describing the possibility of competition introducing a generic version of the drug. The stock began to drop and the company held a CC under the pretense of discussing clinical results of a drug in development called HCV-796. During the CC investors queried management about the issue of generic drugs competing with Vancocin. Management assured investors that to market such a drug would take at least 4 years to complete, giving ViroPharma time to reap plenty of profits. Because ViroPharma is a one product company, bears have recently taken advantage of the threat of competition and moved in. The stock is continuing to drop and today it traded at $16.48.
While observing VPHM the thought occurred to me that Calypte might be positioned to profit similarly. Both are biotech companies having been in product development for years. Both are just beginning to sell products with huge upside potential. Each one has financed operations using equity and debt. Long term debt is significant – Calypte - $150 million, ViroPharma - $236 million. ViroPharma has an exclusive market; Calypte will have the only oral HIV assay in China. Each own products that can save lives and improve patient care. Up to this point conditions are very similar. What are the differences? ViroPharma has only one product (weakness), Calypte will have several (strength). ViroPharma has one market (weakness), Calypte - international and domestic sales (strength). ViroPharma’s O/S is 59 million (strength), Calypte’s is 181 million (weakness).
With just the possibility of $120 million in sales VPHM climbed to a market cap of $1.4 billion. That is an incredible stretch but we all know favorable market conditions produce these high numbers. Calypte’s price with a market cap of $1.4 billion would be $7.73 ps.
10.01.06 14:17
#5044
Kade_I
Joelö, wo bleibt die Charttechnik ?
Die Widerstände, die du hier seit Wochen postest und anpreist, waren ja gestern hammerhart. LOL
12.01.06 14:30
#5045
Kade_I
CHINA-News !!
Calypte Announces Submission of Application to Chinese SFDA
For Approval of its Aware(TM) OMT Oral Fluid HIV-1/2 Rapid Diagnostic Test
LAKE OSWEGO, Ore., Jan 12, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Calypte Biomedical Corporation (Amex: HIV) today announced that it has received notification from the Beijing Drug Administration (BDA) that its application for approval in China of its Aware(TM) OMT (Oral) HIV-1/2 rapid test has been formally accepted. The Company submitted its application to the BDA on December 27, 2005. According to Chinese drug registration regulations, the BDA is responsible for receiving applications on behalf of the State Food and Drug Administration of China (SFDA). Formal acceptance means that the BDA has completed an initial review of the application and deems the application to be sufficiently complete and in compliance with regulations to allow the application to advance into the formal review process.
Roger Gale, Chairman and Chief Executive Officer of Calypte said, "China is one of the countries that may experience a significant spread of HIV unless the government can follow through on its plans to curtail the growth of this problem. China has an acknowledged testing gap and has officially announced plans to offer voluntary HIV testing to its entire 1.36 billion-population, with particular emphasis on certain key groups, for which we believe our test is particularly appropriate. We believe that the only effective way to manage such testing thresholds is to utilize trained non-professionals to administer a program based on safe, non-blood or alternative fluid -- oral fluid -- testing."
Dr. Ron Mink, Chief Science Officer of Calypte added, "With the acceptance of our application by the BDA, Calypte has accomplished a key milestone in obtaining approval to sell our Aware(TM) HIV 1/2 OMT Rapid oral fluid product in the Chinese market. We believe that this product will have great appeal in China by virtue of its superior performance, competitive cost and advantages afforded by the use of oral fluid samples over other products available now or anticipated in the near future, in China."
About China:
China has a population of approximately 1.4 billion. According to a joint China, World Health Organization and UNAIDS epidemiological survey there were a reported 840,000 adults and children in China living with HIV/AIDS in 2003. Some experts have predicted that the number of infections by 2010 might exceed 15 million. The annual AIDS testing level is currently estimated at 1.5% of the population but is expected to grow -- partially due to a formal focus on mandatory testing in large markets such as population control, prisons and immigration and partially due to the Chinese government's program to offer voluntary HIV testing to its entire population.
About Calypte Biomedical:
Calypte Biomedical Corporation is a US-based healthcare company focused on the development and commercialization of diagnostic testing products for the detection of sexually transmitted diseases. Calypte specializes in novel tests such as the HIV-1 BED Incidence EIA and is engaged in developing and commercializing new diagnostic test products for the rapid detection of HIV and other sexually transmitted diseases, several of which do not require blood samples. Calypte believes that there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in lesser-developed countries, which lack the medical infrastructure to support laboratory-based testing. Calypte believes that testing for HIV and other sexually transmitted infectious diseases may make important contributions to public health, and could increase the likelihood of treating those with undetected HIV and other sexually transmitted diseases.
Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the Company's ability to obtain additional financing, if and as needed, and access funds from its existing financing arrangements that will allow it to continue its current and future operations and whether demand for its test products in domestic and international markets will generate sufficient revenues to achieve positive cash flow and profitability. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in the Company's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact the Company's success are more fully disclosed in the Company's most recent public filings with the U.S. Securities and Exchange Commission ("SEC"), including its annual report on Form 10-KSB/A (No. 2) for the year ended December 31, 2004 and its subsequent filings with the SEC.
For Approval of its Aware(TM) OMT Oral Fluid HIV-1/2 Rapid Diagnostic Test
LAKE OSWEGO, Ore., Jan 12, 2006 /PRNewswire-FirstCall via COMTEX News Network/ -- Calypte Biomedical Corporation (Amex: HIV) today announced that it has received notification from the Beijing Drug Administration (BDA) that its application for approval in China of its Aware(TM) OMT (Oral) HIV-1/2 rapid test has been formally accepted. The Company submitted its application to the BDA on December 27, 2005. According to Chinese drug registration regulations, the BDA is responsible for receiving applications on behalf of the State Food and Drug Administration of China (SFDA). Formal acceptance means that the BDA has completed an initial review of the application and deems the application to be sufficiently complete and in compliance with regulations to allow the application to advance into the formal review process.
Roger Gale, Chairman and Chief Executive Officer of Calypte said, "China is one of the countries that may experience a significant spread of HIV unless the government can follow through on its plans to curtail the growth of this problem. China has an acknowledged testing gap and has officially announced plans to offer voluntary HIV testing to its entire 1.36 billion-population, with particular emphasis on certain key groups, for which we believe our test is particularly appropriate. We believe that the only effective way to manage such testing thresholds is to utilize trained non-professionals to administer a program based on safe, non-blood or alternative fluid -- oral fluid -- testing."
Dr. Ron Mink, Chief Science Officer of Calypte added, "With the acceptance of our application by the BDA, Calypte has accomplished a key milestone in obtaining approval to sell our Aware(TM) HIV 1/2 OMT Rapid oral fluid product in the Chinese market. We believe that this product will have great appeal in China by virtue of its superior performance, competitive cost and advantages afforded by the use of oral fluid samples over other products available now or anticipated in the near future, in China."
About China:
China has a population of approximately 1.4 billion. According to a joint China, World Health Organization and UNAIDS epidemiological survey there were a reported 840,000 adults and children in China living with HIV/AIDS in 2003. Some experts have predicted that the number of infections by 2010 might exceed 15 million. The annual AIDS testing level is currently estimated at 1.5% of the population but is expected to grow -- partially due to a formal focus on mandatory testing in large markets such as population control, prisons and immigration and partially due to the Chinese government's program to offer voluntary HIV testing to its entire population.
About Calypte Biomedical:
Calypte Biomedical Corporation is a US-based healthcare company focused on the development and commercialization of diagnostic testing products for the detection of sexually transmitted diseases. Calypte specializes in novel tests such as the HIV-1 BED Incidence EIA and is engaged in developing and commercializing new diagnostic test products for the rapid detection of HIV and other sexually transmitted diseases, several of which do not require blood samples. Calypte believes that there is a significant need for rapid detection of such diseases globally to control their proliferation, particularly in lesser-developed countries, which lack the medical infrastructure to support laboratory-based testing. Calypte believes that testing for HIV and other sexually transmitted infectious diseases may make important contributions to public health, and could increase the likelihood of treating those with undetected HIV and other sexually transmitted diseases.
Statements in this press release that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933, as amended. Those statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to, the Company's ability to obtain additional financing, if and as needed, and access funds from its existing financing arrangements that will allow it to continue its current and future operations and whether demand for its test products in domestic and international markets will generate sufficient revenues to achieve positive cash flow and profitability. The Company undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in the Company's expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact the Company's success are more fully disclosed in the Company's most recent public filings with the U.S. Securities and Exchange Commission ("SEC"), including its annual report on Form 10-KSB/A (No. 2) for the year ended December 31, 2004 and its subsequent filings with the SEC.
12.01.06 14:36
#5047
Nebelland2005
Extremer Kursanstieg!!
Mal sehen was in den USA heute geht.
Realtime:
14:33:33 0,210 +42,86%
+0,063
Taxe Stück
Bid: 14:33:36 0,190 0
Ask: 14:33:36 0,215 0
Realtime:
14:33:33 0,210 +42,86%
+0,063
Taxe Stück
Bid: 14:33:36 0,190 0
Ask: 14:33:36 0,215 0
12.01.06 14:49
#5048
Nebelland2005
Weils so schön ist hier nochmals ein RT :-))))
Kursdaten 12.01.2006 Stuttgart
Realtime:
14:33:33 0,210 +42,86%
+0,063
Taxe Stück
Bid: 14:48:17 0,230 0
Ask: 14:48:17 0,250 0
Realtime:
14:33:33 0,210 +42,86%
+0,063
Taxe Stück
Bid: 14:48:17 0,230 0
Ask: 14:48:17 0,250 0