Hiv-il Ritorno Dei Morti Viventi
- Creatore Discussione martino72
- Data di inizio
...Calypte Biomedical Corp. (HIV): the Lake Oswego, Oregon based company develops urine-based HIV antibody test which is sold in United States, China and Brazil...giumi69 ha scritto:
quindi questi test sono già venduti in Cina!?
ammangi ha scritto:...Calypte Biomedical Corp. (HIV): the Lake Oswego, Oregon based company develops urine-based HIV antibody test which is sold in United States, China and Brazil...
quindi questi test sono già venduti in Cina!?
La data è del 30.03, ma credo ci sia un errore..... Non credo stiano già vendendo in Cina.....altrim. siamo fritti.......
Gian
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Q&A Session from the CC...
Moderator: Your first question comes from the line of John Schneller of Knott Partners, please go ahead.
John Schneller: Hello and thank you for taking my call. Um, this Company has been at, in quotes “critical junctures” at various times over its life for the past ten or so years, um, and the translation of that from a shareholder value perspective has been continued unbridled printing of equity heaped on the back of shareholders. Now I know this specific management team has only been in place for a short period of time, although, ah, Rick Brounstien continues to somehow hang on, ah, but, ah, my question is – what can you say that is going to lead shareholders to understand that this critical juncture and inflection point is not just going to cause an additional heaping of equity onto the market and by my math, fully diluted all in options or in ah, equity options etc., convertible debentures, ah, that have equity components puts the share count at over 335 million, um, so, that’s my question?
Roger Gale Interim CEO: Thank you Mr. Schneller, question and very strong comment you’ve made. I have been Chairman of the Company for some period of time and the Interim CEO since last October. I’m a businessman by nature and when Ted presented the results today, and you see the 10K tomorrow I think the results speak very much for themselves. The burn rate has been significantly reduced, the Company has delivered a new suite of products to the market place and is working on a second suite, sorry, a suite of second generation products. The testing out in the market place, in particular, Africa; the lining up of the products and new markets around the world, as well as the formation of the Joint Venture, the acquisition of a plant in China. We believe we are truly at the juncture of a significant breakthrough in the performance of the Company. We have worked since the last quarter of last year to re-define the objectives and strategy for the Company and we believe those objectives and strategies are absolutely right now to guide us through 2006 and 2007. I fully appreciate that this success has been long time in coming, and a considerable amount of time and effort and money have been invested to get us this far, but I truly believe, and I think the management truly believe that we are genuinely at a point where we are on the road to profitability, sustained profitability. It is still going to take us some time, the science is done, but unfortunately delivering the business performance is not a question of science now, it’s a question of gaining access to the markets and gaining sales. And that is a considerable amount of hard work still to be done but building on the science and market development work that’s already been done. And that has been achieve not just in the last few months but that work has been going on for several years, in large part by many of the mangers who are still with the Company including Mr. Brounstien that you referred to.
John Schneller: So, in, in terms of additional time, time of course would translate into additional money which would contribute, which would translate into additional equity printing.
Roger Gale Interim CEO: The Company has an amount of cash which will take us through the end of the second quarter, into the third quarter, and at some point in time we are going to have to go back into the marketplace to raise additional financing.
John Schneller: Thank you!
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Moderator: Your next question comes from the line of Robert Patraza, private investor.
Moderator: Your first question comes from the line of John Schneller of Knott Partners, please go ahead.
John Schneller: Hello and thank you for taking my call. Um, this Company has been at, in quotes “critical junctures” at various times over its life for the past ten or so years, um, and the translation of that from a shareholder value perspective has been continued unbridled printing of equity heaped on the back of shareholders. Now I know this specific management team has only been in place for a short period of time, although, ah, Rick Brounstien continues to somehow hang on, ah, but, ah, my question is – what can you say that is going to lead shareholders to understand that this critical juncture and inflection point is not just going to cause an additional heaping of equity onto the market and by my math, fully diluted all in options or in ah, equity options etc., convertible debentures, ah, that have equity components puts the share count at over 335 million, um, so, that’s my question?
Roger Gale Interim CEO: Thank you Mr. Schneller, question and very strong comment you’ve made. I have been Chairman of the Company for some period of time and the Interim CEO since last October. I’m a businessman by nature and when Ted presented the results today, and you see the 10K tomorrow I think the results speak very much for themselves. The burn rate has been significantly reduced, the Company has delivered a new suite of products to the market place and is working on a second suite, sorry, a suite of second generation products. The testing out in the market place, in particular, Africa; the lining up of the products and new markets around the world, as well as the formation of the Joint Venture, the acquisition of a plant in China. We believe we are truly at the juncture of a significant breakthrough in the performance of the Company. We have worked since the last quarter of last year to re-define the objectives and strategy for the Company and we believe those objectives and strategies are absolutely right now to guide us through 2006 and 2007. I fully appreciate that this success has been long time in coming, and a considerable amount of time and effort and money have been invested to get us this far, but I truly believe, and I think the management truly believe that we are genuinely at a point where we are on the road to profitability, sustained profitability. It is still going to take us some time, the science is done, but unfortunately delivering the business performance is not a question of science now, it’s a question of gaining access to the markets and gaining sales. And that is a considerable amount of hard work still to be done but building on the science and market development work that’s already been done. And that has been achieve not just in the last few months but that work has been going on for several years, in large part by many of the mangers who are still with the Company including Mr. Brounstien that you referred to.
John Schneller: So, in, in terms of additional time, time of course would translate into additional money which would contribute, which would translate into additional equity printing.
Roger Gale Interim CEO: The Company has an amount of cash which will take us through the end of the second quarter, into the third quarter, and at some point in time we are going to have to go back into the marketplace to raise additional financing.
John Schneller: Thank you!
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Moderator: Your next question comes from the line of Robert Patraza, private investor.
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Please proceed.
Robert Patraza: First let me say that I appreciate the question and the point that the prior caller made. Um, you made reference to science and then the commercial development, do you have the people that can make, you know, that, that can make a difference in the commercialization of the technology? You yourself stated earlier, they’ve been at it several years, at what point does the issue come, do we have the right people, both out in the field and in the position that you sit in as well?
Roger Gale Interim CEO: Thank you very much Robert, very good question! I believe we have an expert management team for the point at which the Company is in its current life. Clearly we must have traction of sales, without sales, the Company’s not a philanthropic organization designed to use up shareholders money. I firmly believe that with the management team that we have to be augmented by a full time Chief Executive Officer we will have the makings of the team to carry the business forward through 2006, through 2007, 2008. The business plan is very much focused on a set of financial objectives, operational objectives through 2006 and strategies to achieve them. Once this new CEO is in place, the CEO will be given leeway to recruit a new head of marketing and potentially a new Chief Operating Officer. Those are the two key positions which the Company now needs. I believe it would have been premature to put those two positions in place in advance of finding a new CEO. We believe we have found the right man to carry the Company forward.
Robert Patraza: You referenced milestones, uh, objectives, 07, 08, is this clearly articulated somewhere for public inspection so that we can hold yourself and these prospective executives accountable?
Roger Gale Interim CEO: The objectives both financial operational and the strategies to achieve them are set out in the business plan approved by the Board of Directors in February of this year. Those objectives and those strategies you will be able to measure the performance of the Company as we step forward with the quarterly performance of the Company during the course of 2006 and 2007.
Ted Gwin CFO: I might add to the extent it’s available the 10K will have some of those objectives in it.
Robert Patraza: Ok, you, so you say some, what about the others?
Roger Gale Interim CEO: We have very clear set of objectives and strategies to achieve them and I believe this is the first time in the history of the Company we’ve been able to do this. I believe it’s also the first time in the history of the Company that quarter on quarter I think we are able to say that we’re beginning to achieve the objectives and the strategies we’ve set out for the Company. We are now running a business where we have a strategy, individual staff members, individual parts of the Company have to deliver against those objectives and the strategies set out for them.
Robert Patraza: Thank you!
Roger Gale Interim CEO: If I might add Robert, if we had more time I think I would be prepared to give you more information as to what those objectives and strategies are but I have given you the highlights of the objectives of 2006 and beyond as well as a sense of the strategy that we’re going to employ to achieve them.
Robert Patraza: First let me say that I appreciate the question and the point that the prior caller made. Um, you made reference to science and then the commercial development, do you have the people that can make, you know, that, that can make a difference in the commercialization of the technology? You yourself stated earlier, they’ve been at it several years, at what point does the issue come, do we have the right people, both out in the field and in the position that you sit in as well?
Roger Gale Interim CEO: Thank you very much Robert, very good question! I believe we have an expert management team for the point at which the Company is in its current life. Clearly we must have traction of sales, without sales, the Company’s not a philanthropic organization designed to use up shareholders money. I firmly believe that with the management team that we have to be augmented by a full time Chief Executive Officer we will have the makings of the team to carry the business forward through 2006, through 2007, 2008. The business plan is very much focused on a set of financial objectives, operational objectives through 2006 and strategies to achieve them. Once this new CEO is in place, the CEO will be given leeway to recruit a new head of marketing and potentially a new Chief Operating Officer. Those are the two key positions which the Company now needs. I believe it would have been premature to put those two positions in place in advance of finding a new CEO. We believe we have found the right man to carry the Company forward.
Robert Patraza: You referenced milestones, uh, objectives, 07, 08, is this clearly articulated somewhere for public inspection so that we can hold yourself and these prospective executives accountable?
Roger Gale Interim CEO: The objectives both financial operational and the strategies to achieve them are set out in the business plan approved by the Board of Directors in February of this year. Those objectives and those strategies you will be able to measure the performance of the Company as we step forward with the quarterly performance of the Company during the course of 2006 and 2007.
Ted Gwin CFO: I might add to the extent it’s available the 10K will have some of those objectives in it.
Robert Patraza: Ok, you, so you say some, what about the others?
Roger Gale Interim CEO: We have very clear set of objectives and strategies to achieve them and I believe this is the first time in the history of the Company we’ve been able to do this. I believe it’s also the first time in the history of the Company that quarter on quarter I think we are able to say that we’re beginning to achieve the objectives and the strategies we’ve set out for the Company. We are now running a business where we have a strategy, individual staff members, individual parts of the Company have to deliver against those objectives and the strategies set out for them.
Robert Patraza: Thank you!
Roger Gale Interim CEO: If I might add Robert, if we had more time I think I would be prepared to give you more information as to what those objectives and strategies are but I have given you the highlights of the objectives of 2006 and beyond as well as a sense of the strategy that we’re going to employ to achieve them.
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Robert Patraza: Greater detail and depth, as we move forward and the calls that are going to happen in the near future, it would certainly be appreciated I’m sure by everyone.
Roger Gale Interim CEO: Yes, Robert and I think we be in a position to deliver them.
Robert Patraza: Thank you!
Roger: Thank you!
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Moderator: The next question comes from the line of Daniel Quidel, private investor. Please proceed.
Daniel Quidel: Yes, hello, um, I would like to, uh, ask exactly what happened with the AMEX delisting meeting? We never heard anything about that, uh, what was it that you presented to the AMEX and uh, what, uh set of milestones or requirements did the AMEX, uh put on to the Company? And will you accomplish those, whatever they may be?
Roger Gale Interim CEO: Thank you Daniel, I’m going to turn the response of your question over to Rick Brounstien who is heading up our AMEX response.
Rick Brounstien, Executive Vice President: Hi, this is Rick, actually I was at the hearing, we made a presentation in person and basically we laid out much of what you heard from Roger today. I think you saw the results, that they basically have given us a series of months. They have defined criteria to get back on (transcriber: can’t discern word) equity levels, base on different levels of profitability and we basically told them that we thought we had a great business going forward. We think that they should be proud to have us as part of the AMEX and that at best they ought to wait several months and watch as we start to roll out the strategy now and see if indeed we meet their criteria. So, they gave us basically to the end of July which is essentially to see what we do in the second quarter and then it’ll be published in the SEC filings at the end of June.
Daniel Quidel: Well I guess my concern is that with your fourth quarter sales, I mean, $133,000 dollars is just not much in sales, ah, it seems to me that you’re, you’re quite a ways from actually turning the corner into a profitability situation. I know you’ve done a great job cutting expenses, but you’ve got to get the sales up and uh, seven thirty one is only ninety days away, um, it, it, its, and you don’t have China approved, uh, Kenya just got approved, where are the sales going to come from, where are the revenue streams going to come from?
Rick Brounstien, EVP: We didn’t make any claims that we think that we’re going to get to sales and the revenue to the point where we would be profitable in the next three months.
Daniel Quidel: Well how do you keep compliant? That’s my question.
Rick Brounstien, EVP: The compliance is not based on revenues and profits it’s based on basically going through a structuring of the Company and making sure that the balance sheet stands up to their criteria.
Daniel Quidel: Ok, with respect to that you’ve got the Marr credit line that is, is ah, still there for uh, up until somewhere in the middle of the year, uh, can you comment in any
Roger Gale Interim CEO: Yes, Robert and I think we be in a position to deliver them.
Robert Patraza: Thank you!
Roger: Thank you!
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Moderator: The next question comes from the line of Daniel Quidel, private investor. Please proceed.
Daniel Quidel: Yes, hello, um, I would like to, uh, ask exactly what happened with the AMEX delisting meeting? We never heard anything about that, uh, what was it that you presented to the AMEX and uh, what, uh set of milestones or requirements did the AMEX, uh put on to the Company? And will you accomplish those, whatever they may be?
Roger Gale Interim CEO: Thank you Daniel, I’m going to turn the response of your question over to Rick Brounstien who is heading up our AMEX response.
Rick Brounstien, Executive Vice President: Hi, this is Rick, actually I was at the hearing, we made a presentation in person and basically we laid out much of what you heard from Roger today. I think you saw the results, that they basically have given us a series of months. They have defined criteria to get back on (transcriber: can’t discern word) equity levels, base on different levels of profitability and we basically told them that we thought we had a great business going forward. We think that they should be proud to have us as part of the AMEX and that at best they ought to wait several months and watch as we start to roll out the strategy now and see if indeed we meet their criteria. So, they gave us basically to the end of July which is essentially to see what we do in the second quarter and then it’ll be published in the SEC filings at the end of June.
Daniel Quidel: Well I guess my concern is that with your fourth quarter sales, I mean, $133,000 dollars is just not much in sales, ah, it seems to me that you’re, you’re quite a ways from actually turning the corner into a profitability situation. I know you’ve done a great job cutting expenses, but you’ve got to get the sales up and uh, seven thirty one is only ninety days away, um, it, it, its, and you don’t have China approved, uh, Kenya just got approved, where are the sales going to come from, where are the revenue streams going to come from?
Rick Brounstien, EVP: We didn’t make any claims that we think that we’re going to get to sales and the revenue to the point where we would be profitable in the next three months.
Daniel Quidel: Well how do you keep compliant? That’s my question.
Rick Brounstien, EVP: The compliance is not based on revenues and profits it’s based on basically going through a structuring of the Company and making sure that the balance sheet stands up to their criteria.
Daniel Quidel: Ok, with respect to that you’ve got the Marr credit line that is, is ah, still there for uh, up until somewhere in the middle of the year, uh, can you comment in any
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more detail exactly uh, you know, where the money is comes from?
Roger Gale Interim CEO: I’m sorry could you repeat that again Daniel? “Where the additional…”
Daniel Quidel: You’ve got the Marr Credit, which is what about a million and a half at this point? Is that right?
Roger Gale Interim CEO: I will ask Ted to respond to your point. Ted Gwin.
Ted Gwin CFO: Actually it’s about a little over two million dollars left on the loan.
Daniel Quidel: Ok, and, and so that’s, uh, that’s plenty of time but there’s also a lot of offsetting debt in your company. Uh, I’m not sure that I understand exactly how the uh, numbers match up to, to keep uh, to keep your listing by seven thirty one? It seems to me like you need an influx of money and I’m just trying to understand where it’s going to come from.
Rick Brounstien, EVP: The nature, what it is, I can tell you where we stand, at the extent we stand, but it’s, um, clearly it’s going to require partially a, uh, additional financing. The types for that financing that are likely available to us are going to be similar to financings we’ve done in the past, such as some form of a PIPE. I really expect in total, in order to execute the plans we’re talking about here, we’re looking at needing to raise, somewhere in the nature of $10 million dollars of maybe even a little more. But the terms of such financing and the nature have not been determined. We’ve begun the process of exploring various alternatives that might be available to us, we’re talking with a couple of placement agents, but there’s no assurance that we can obtain it. The message will be much like the AMEX’s will be you’ll have to stay tuned and watch us perform over the next few months.
Daniel Quidel: One more different thing, I guess I don’t understand exactly the pricing structure of the new products? Can you talk to us about how much the individual tests cost?
Ted Gwin CFO: Which product exactly are you talking about?
Roger Gale Interim CEO: Ted Gwin on the line now, Daniel.
Daniel Quidel: You can talk about all of them, I guess, I’m specifically interested in the Oral fluid test, uh, the new Aware® test.
Ted Gwin CFO: Well the, we plan on being in the market with that test somewhere around a $1.60 per test.
Daniel Quidel: And what is your margin on that test?
Ted Gwin CFO: That should be somewhere in the neighborhood of 42%.
Daniel Quidel: Ok! And do you think that that’s going to be competitive with other rapid tests that are available in the $0.50, $0.75 range?
Ted Gwin CFO: Well clearly the only other rapid OMT test there is, it’s clearly competitive
Roger Gale Interim CEO: I’m sorry could you repeat that again Daniel? “Where the additional…”
Daniel Quidel: You’ve got the Marr Credit, which is what about a million and a half at this point? Is that right?
Roger Gale Interim CEO: I will ask Ted to respond to your point. Ted Gwin.
Ted Gwin CFO: Actually it’s about a little over two million dollars left on the loan.
Daniel Quidel: Ok, and, and so that’s, uh, that’s plenty of time but there’s also a lot of offsetting debt in your company. Uh, I’m not sure that I understand exactly how the uh, numbers match up to, to keep uh, to keep your listing by seven thirty one? It seems to me like you need an influx of money and I’m just trying to understand where it’s going to come from.
Rick Brounstien, EVP: The nature, what it is, I can tell you where we stand, at the extent we stand, but it’s, um, clearly it’s going to require partially a, uh, additional financing. The types for that financing that are likely available to us are going to be similar to financings we’ve done in the past, such as some form of a PIPE. I really expect in total, in order to execute the plans we’re talking about here, we’re looking at needing to raise, somewhere in the nature of $10 million dollars of maybe even a little more. But the terms of such financing and the nature have not been determined. We’ve begun the process of exploring various alternatives that might be available to us, we’re talking with a couple of placement agents, but there’s no assurance that we can obtain it. The message will be much like the AMEX’s will be you’ll have to stay tuned and watch us perform over the next few months.
Daniel Quidel: One more different thing, I guess I don’t understand exactly the pricing structure of the new products? Can you talk to us about how much the individual tests cost?
Ted Gwin CFO: Which product exactly are you talking about?
Roger Gale Interim CEO: Ted Gwin on the line now, Daniel.
Daniel Quidel: You can talk about all of them, I guess, I’m specifically interested in the Oral fluid test, uh, the new Aware® test.
Ted Gwin CFO: Well the, we plan on being in the market with that test somewhere around a $1.60 per test.
Daniel Quidel: And what is your margin on that test?
Ted Gwin CFO: That should be somewhere in the neighborhood of 42%.
Daniel Quidel: Ok! And do you think that that’s going to be competitive with other rapid tests that are available in the $0.50, $0.75 range?
Ted Gwin CFO: Well clearly the only other rapid OMT test there is, it’s clearly competitive
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with that. There are blood products on the market that are extremely cheap and um…
Daniel Quidel: Right, and that’s my question is, you know, are people going to spring for the extra cash to get the oral test or will they stick with the blood test that’s cheaper.
Ted Gwin CFO: Well what happens is, with the oral fluid is you end up getting many more people testing than you would on the blood product. And the number of people being tested is more important overall to the people who are actually buying the tests.
Daniel Quidel: But what I’m asking is, are hospitals and medical professionals eager to get the oral fluid test, instead of the blood test, when they have a choice.
Ted Gwin CFO: Well if it’ll increase the number of people being tested – yes!
Roger Gale Interim CEO: There is to some extent, Daniel I think we view this very much as our (transcriber: can’t discern word) the oral fluid test is of course non-invasive, painless sampling and there are plenty of studies to show greater acceptance of HIV testing without blood, and we therefore, and the entities funding them are expecting significantly higher testing rates, which is of course the key to controlling AIDS. It’s also easy to use; it’s the perfect over-the-counter home test. Technicians are not required, no lancets, no needles. It’s also much safer, there are no infectious blood agents, there’s no accidental needle sticks among health care workers, there’s no risk of needle re-use and there are no disposal issues. And this we believe is a significant play into the over-the-counter market for Calypte.
Daniel Quidel: And your product is on the market in UAE, how is that being received there?
Ted Gwin CFO: Well, it’s too early to tell. I mean it’s been on the market less than a month and so I mean it’s much too early to tell how it’s being accepted.
Daniel Quidel: I just didn’t know if you might have, you know, tremendous response from your sales forces and you know, you’re being surprised by the amount of products you’re shipping to UAE or, you know, maybe it’s going the other way, just didn’t know.
Ted Gwin CFO: Yah, no, at this time it’s just too early to tell.
Daniel Quidel: Ok!
Ted Gwin CFO: It was just launched, introduced at the Arab Health Conference the end of January and it’s too much into the cycle, too early to tell.
Daniel Quidel: Ok!
Ted Gwin CFO: One of the things that we’ve learned is that health care workers and governments all over the world have said that if they can test more people; getting to that point makes the biggest difference. And the oral fluid test is one of those vehicles that allow them to test more people.
Daniel Quidel: Ok, I have more questions but you may have some other people that you want to get to, I don’t know if you want me to keep going or not?
Daniel Quidel: Right, and that’s my question is, you know, are people going to spring for the extra cash to get the oral test or will they stick with the blood test that’s cheaper.
Ted Gwin CFO: Well what happens is, with the oral fluid is you end up getting many more people testing than you would on the blood product. And the number of people being tested is more important overall to the people who are actually buying the tests.
Daniel Quidel: But what I’m asking is, are hospitals and medical professionals eager to get the oral fluid test, instead of the blood test, when they have a choice.
Ted Gwin CFO: Well if it’ll increase the number of people being tested – yes!
Roger Gale Interim CEO: There is to some extent, Daniel I think we view this very much as our (transcriber: can’t discern word) the oral fluid test is of course non-invasive, painless sampling and there are plenty of studies to show greater acceptance of HIV testing without blood, and we therefore, and the entities funding them are expecting significantly higher testing rates, which is of course the key to controlling AIDS. It’s also easy to use; it’s the perfect over-the-counter home test. Technicians are not required, no lancets, no needles. It’s also much safer, there are no infectious blood agents, there’s no accidental needle sticks among health care workers, there’s no risk of needle re-use and there are no disposal issues. And this we believe is a significant play into the over-the-counter market for Calypte.
Daniel Quidel: And your product is on the market in UAE, how is that being received there?
Ted Gwin CFO: Well, it’s too early to tell. I mean it’s been on the market less than a month and so I mean it’s much too early to tell how it’s being accepted.
Daniel Quidel: I just didn’t know if you might have, you know, tremendous response from your sales forces and you know, you’re being surprised by the amount of products you’re shipping to UAE or, you know, maybe it’s going the other way, just didn’t know.
Ted Gwin CFO: Yah, no, at this time it’s just too early to tell.
Daniel Quidel: Ok!
Ted Gwin CFO: It was just launched, introduced at the Arab Health Conference the end of January and it’s too much into the cycle, too early to tell.
Daniel Quidel: Ok!
Ted Gwin CFO: One of the things that we’ve learned is that health care workers and governments all over the world have said that if they can test more people; getting to that point makes the biggest difference. And the oral fluid test is one of those vehicles that allow them to test more people.
Daniel Quidel: Ok, I have more questions but you may have some other people that you want to get to, I don’t know if you want me to keep going or not?
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Roger Gale Interim CEO: Thank you Daniel, good questions and I’m sure if the other questioners don’t raise your points I’m sure our chairman will give you a chance towards the end.
Daniel Quidel: Ok, thanks!
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Moderator: The next question comes from the line of Brian Davidson with SF Capital, please proceed.
Brian Davidson: Hi Roger, how are you?
Roger Gale Interim CEO: Hi Brian, how are you? Very good thank you!
Brian Davidson: Good job! I appreciate all the detail and I appreciate your collective willingness to field all of these somewhat hostile questions you’ve been fielding so far. But I have a couple questions myself. In terms of China, I think Ted mentioned at the outset there’s a defined period of time like here in the US for a response. I think I heard you say Roger that you expected that by mid year? Is that right?
Ted Gwin, CFO: Yeah, from the time they receive the submission till they have to do an initial response is a hundred days.
Brian Davidson: Ok, so is it from when they accepted it, Ted? Or is it when they received it?
Ted Gwin, CFO: When they accept it.
Brian Davidson: So then it was in…
Ted Gwin, CFO: Mid January.
Brian Davidson: So a hundred days from mid January.
Roger Gale Interim CEO: Brian, we have Chris Kafka with us who is the Chief Operating Officer for the Joint Venture in China. I think he just wants to augment what Ted has just said.
Chris Kafka: There’s actually two points of acceptance, one is the acceptance of the applications at the provincial level, and that happened in early to mid January. From that point at the provincial level the BDA has thirty days to do an initial review and as well as an inspection of the facility and then from there the application is passed on to the State level SFDA. That transition happened in mid February and that is when the hundred day clock starts ticking. A little detail, but I thought I might add that.
Brian Davidson: Yah, it’s important, a hundred days from February. And then I was going to ask, Chris, is there any historical precedent? Does anybody have a sense as to whether you are going to have a strong probability of getting comments?
Ted Gwin, CFO: Let me answer that question. From the experience from the Epitope days with the oral fluid test, if the US FDA is any indication, we expect to have additional
Daniel Quidel: Ok, thanks!
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Moderator: The next question comes from the line of Brian Davidson with SF Capital, please proceed.
Brian Davidson: Hi Roger, how are you?
Roger Gale Interim CEO: Hi Brian, how are you? Very good thank you!
Brian Davidson: Good job! I appreciate all the detail and I appreciate your collective willingness to field all of these somewhat hostile questions you’ve been fielding so far. But I have a couple questions myself. In terms of China, I think Ted mentioned at the outset there’s a defined period of time like here in the US for a response. I think I heard you say Roger that you expected that by mid year? Is that right?
Ted Gwin, CFO: Yeah, from the time they receive the submission till they have to do an initial response is a hundred days.
Brian Davidson: Ok, so is it from when they accepted it, Ted? Or is it when they received it?
Ted Gwin, CFO: When they accept it.
Brian Davidson: So then it was in…
Ted Gwin, CFO: Mid January.
Brian Davidson: So a hundred days from mid January.
Roger Gale Interim CEO: Brian, we have Chris Kafka with us who is the Chief Operating Officer for the Joint Venture in China. I think he just wants to augment what Ted has just said.
Chris Kafka: There’s actually two points of acceptance, one is the acceptance of the applications at the provincial level, and that happened in early to mid January. From that point at the provincial level the BDA has thirty days to do an initial review and as well as an inspection of the facility and then from there the application is passed on to the State level SFDA. That transition happened in mid February and that is when the hundred day clock starts ticking. A little detail, but I thought I might add that.
Brian Davidson: Yah, it’s important, a hundred days from February. And then I was going to ask, Chris, is there any historical precedent? Does anybody have a sense as to whether you are going to have a strong probability of getting comments?
Ted Gwin, CFO: Let me answer that question. From the experience from the Epitope days with the oral fluid test, if the US FDA is any indication, we expect to have additional
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comments and questions come back and their going to be asking for additional data. That’s our preliminary guess, we have no indication at this time, how it’s going to turn out. And they have no reason to respond at all until that hundred day clock has run out.
Brian Davidson: You mentioned this facility that you guys are now partner with Marr on, I think somebody said 17 approved products? Is there any anticipation that you’ll be generating any sort of revenue from whatever those products are in 2006?
Roger Gale Interim CEO: We can probably have Chris Kafka comment on that. And if he misses anything Ted will jump in.
Chris Kafka: We are hoping be able to continue selling these products. All these products are approved by the SFDA and we’re currently undergoing a technology transfer of those products under our control. Once that technology transfer has been completed and we’ve been able to do a comprehensive assessment of those products, vis-à-vis our own quality standards we’re going to make a final assessment of which products, we as a company will continue to sell.
Ted Gwin, CFO: We’re also going to do, or in the process of doing a market acceptance for each one of those products, to find out if it’s something we want to continue, if it’s going to be a profitable product and how big the market is in China.
Brian Davidson: Can you give a description of what types of products that this facility makes?
Chris Kafka: They are all diagnostic products. By and large they’re products for STD’s including a HIV 1-2 EIA test, an HIV 1-2 Rapid test that would be a very good complement to our own Aware® Line of BSP tests. There’s also some tests for Syphilis. There are a variety of tests for Hepatitis, Hepatitis C, Hepatitis B, Surface Antigen and Core Antigen. There is also a drugs of abuse test, in the lot, but that’s really the only non-disease type test in the lot.
Brian Davidson: When you say “technology transfer” are you talking about putting in your own (transcriber: can’t discern word) and having to get it re-validated or just the new management or new operating folks that have to..?
Chris Kafka: New, primarily it’s a new management team. But we’re also in the process of revising the internal operating procedures of the Company and we will have of course, merge the YaoHua products onto those internal operating procedures.
Roger Gale Interim CEO: I think Brian, if I might just follow on with this point, Chris has corrected something I said, when I gave him my statement, when I referred to building the capacity of the plant to 10 million, I think I said 10 million per year. I think Chris, if I’m corrected; it’s 10 million per month. But it will take us 12 months plus to build capacity to that point. That’s tests of our own Aware® product. So, any other products that are currently of the 17 products that are currently in the plant and are capable of manufacture by us would be incremental to those test levels.
Ted Gwin, CFO: And as soon as time permits, to be able to evaluate those products and being able to get them into production, and into the markets, we can sell them.
Brian Davidson: You mentioned this facility that you guys are now partner with Marr on, I think somebody said 17 approved products? Is there any anticipation that you’ll be generating any sort of revenue from whatever those products are in 2006?
Roger Gale Interim CEO: We can probably have Chris Kafka comment on that. And if he misses anything Ted will jump in.
Chris Kafka: We are hoping be able to continue selling these products. All these products are approved by the SFDA and we’re currently undergoing a technology transfer of those products under our control. Once that technology transfer has been completed and we’ve been able to do a comprehensive assessment of those products, vis-à-vis our own quality standards we’re going to make a final assessment of which products, we as a company will continue to sell.
Ted Gwin, CFO: We’re also going to do, or in the process of doing a market acceptance for each one of those products, to find out if it’s something we want to continue, if it’s going to be a profitable product and how big the market is in China.
Brian Davidson: Can you give a description of what types of products that this facility makes?
Chris Kafka: They are all diagnostic products. By and large they’re products for STD’s including a HIV 1-2 EIA test, an HIV 1-2 Rapid test that would be a very good complement to our own Aware® Line of BSP tests. There’s also some tests for Syphilis. There are a variety of tests for Hepatitis, Hepatitis C, Hepatitis B, Surface Antigen and Core Antigen. There is also a drugs of abuse test, in the lot, but that’s really the only non-disease type test in the lot.
Brian Davidson: When you say “technology transfer” are you talking about putting in your own (transcriber: can’t discern word) and having to get it re-validated or just the new management or new operating folks that have to..?
Chris Kafka: New, primarily it’s a new management team. But we’re also in the process of revising the internal operating procedures of the Company and we will have of course, merge the YaoHua products onto those internal operating procedures.
Roger Gale Interim CEO: I think Brian, if I might just follow on with this point, Chris has corrected something I said, when I gave him my statement, when I referred to building the capacity of the plant to 10 million, I think I said 10 million per year. I think Chris, if I’m corrected; it’s 10 million per month. But it will take us 12 months plus to build capacity to that point. That’s tests of our own Aware® product. So, any other products that are currently of the 17 products that are currently in the plant and are capable of manufacture by us would be incremental to those test levels.
Ted Gwin, CFO: And as soon as time permits, to be able to evaluate those products and being able to get them into production, and into the markets, we can sell them.
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Brian Davidson: Just a couple…real quick, I listened to your comments about the new CEO, the search for a new CEO and your hopes that you’ve identified somebody. Why, and I don’t mean this facetiously but why would someone of the talent be willing to join the Company that admittedly has 6 months or so of cash in place? In other words, are you guys going to have to kind of shore up your financings before somebody will commit? Or is it not necessarily…
Roger Gale Interim CEO: A very good question, Brian as always. I have to be a little bit careful with what I say because he may be listening in. First and foremost this gentleman, as I said in my comments is very experienced. I think has served as Chief Executive Officer in several companies before. I think he’s been in small, medium, large scale companies and I think if he is listening in, I think the point to be made is that he sees in Calypte a company at the absolute inflection point of building to success – sustained profitability. Yes, we will need additional funding, but I think it’s been clear to him, and to the other candidates as well that the future of the Company is very, very bright. And I think it’s that brightness, and now the clarity of the product range and what we’re going to do with the product range and the fact that we’ve actually got a working business model, a working business plan with clear objectives and a clear strategy laid out, I think having the business plan has been very helpful to each of the candidates and in their thinking towards wanting to be involved with the Company. This Chap is about my age, has a considerable amount of experience, yes – in the pharmaceuticals industry and in managing such companies. But I think his business acumen is what makes him particularly attractive to me, and I think he’s looking at us with his business acumen and can see that the Company has a very great future. I think to end I should say that whoever is the wining candidate is going to have to be incentive-ized to join the Company, and the best incentive of all is to empower that individual with an ownership stake, which is something we’re continuing to look at vis-à-vis the current management team we have. We have to look very closely to make sure everybody is aligned in their delivery of success, cause if their out of alignment then they’re not all going to be pulling together.
Brian, I sort of circumvented the actual point, which is - why would someone join a Company like this which still needs funding?– I still haven’t arrived. But I hope that what I’ve said is that this particular candidate has the vision that we all see in the Company.
Brian Davidson: I think that’s a very fit answer and I certainly wouldn’t disagree, I mean we’ve certainly seen a number of situations where bringing in the right person in and of itself is a catalyst for looking at the Company in a new light and accessing capital that perhaps hadn’t been interested in the past. So that’s great!
The only other thing I had is really more of a comment than a question. I don’t really understand why you guys are listed on the AMEX, or desire to maintain your listing on the AMEX. I’m not sure that you derive any benefit from it, in terms of capital raising or marketing or anything. Maybe you do, I just leave that as more of a statement than a question, because in my experience I don’t think people place a whole lot value on being listed on the AMEX versus anywhere else including the Bulletin Board.
Roger Gale Interim CEO: Brian, thank you for the comment which you have given to me before. Thank you!
Brian Davidson: Alright, take care guys!
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Closing remarks:
Roger Gale Interim CEO: Thank you very much indeed, for joining us for this call today. Myself and the management team have spent a considerable amount of time trying to package together as much information as we can on the call, we do realize its been quite some time since we have had an investor call, but the fact of the matter is we wanted to get some success under our belt, and make sure we were very clear on our strategy and objectives for 2006 and 2007 before we talked to you. So thank you very much for participating in the call today and we look forward to talking to you again and hopefully with some more achievements under our belts.
Thank you very much indeed, from myself and the management team.
Roger Gale Interim CEO: A very good question, Brian as always. I have to be a little bit careful with what I say because he may be listening in. First and foremost this gentleman, as I said in my comments is very experienced. I think has served as Chief Executive Officer in several companies before. I think he’s been in small, medium, large scale companies and I think if he is listening in, I think the point to be made is that he sees in Calypte a company at the absolute inflection point of building to success – sustained profitability. Yes, we will need additional funding, but I think it’s been clear to him, and to the other candidates as well that the future of the Company is very, very bright. And I think it’s that brightness, and now the clarity of the product range and what we’re going to do with the product range and the fact that we’ve actually got a working business model, a working business plan with clear objectives and a clear strategy laid out, I think having the business plan has been very helpful to each of the candidates and in their thinking towards wanting to be involved with the Company. This Chap is about my age, has a considerable amount of experience, yes – in the pharmaceuticals industry and in managing such companies. But I think his business acumen is what makes him particularly attractive to me, and I think he’s looking at us with his business acumen and can see that the Company has a very great future. I think to end I should say that whoever is the wining candidate is going to have to be incentive-ized to join the Company, and the best incentive of all is to empower that individual with an ownership stake, which is something we’re continuing to look at vis-à-vis the current management team we have. We have to look very closely to make sure everybody is aligned in their delivery of success, cause if their out of alignment then they’re not all going to be pulling together.
Brian, I sort of circumvented the actual point, which is - why would someone join a Company like this which still needs funding?– I still haven’t arrived. But I hope that what I’ve said is that this particular candidate has the vision that we all see in the Company.
Brian Davidson: I think that’s a very fit answer and I certainly wouldn’t disagree, I mean we’ve certainly seen a number of situations where bringing in the right person in and of itself is a catalyst for looking at the Company in a new light and accessing capital that perhaps hadn’t been interested in the past. So that’s great!
The only other thing I had is really more of a comment than a question. I don’t really understand why you guys are listed on the AMEX, or desire to maintain your listing on the AMEX. I’m not sure that you derive any benefit from it, in terms of capital raising or marketing or anything. Maybe you do, I just leave that as more of a statement than a question, because in my experience I don’t think people place a whole lot value on being listed on the AMEX versus anywhere else including the Bulletin Board.
Roger Gale Interim CEO: Brian, thank you for the comment which you have given to me before. Thank you!
Brian Davidson: Alright, take care guys!
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Closing remarks:
Roger Gale Interim CEO: Thank you very much indeed, for joining us for this call today. Myself and the management team have spent a considerable amount of time trying to package together as much information as we can on the call, we do realize its been quite some time since we have had an investor call, but the fact of the matter is we wanted to get some success under our belt, and make sure we were very clear on our strategy and objectives for 2006 and 2007 before we talked to you. So thank you very much for participating in the call today and we look forward to talking to you again and hopefully with some more achievements under our belts.
Thank you very much indeed, from myself and the management team.
e che qualcuno ce la mandi buona..... come non detto!!!!
questo titolo non mi smentisce mai!!!!!
0,19 e siamo tornati alla casella di partenza
per lo meno il grafico ed i saltuari movimenti up con notevole volume dimostrano che questo titolo del c. è molto sorvegliato
aspettiamo giugno (altro non c'è da fa...)
questo titolo non mi smentisce mai!!!!! 0,19 e siamo tornati alla casella di partenza
per lo meno il grafico ed i saltuari movimenti up con notevole volume dimostrano che questo titolo del c. è molto sorvegliato aspettiamo giugno (altro non c'è da fa...)
