Calypte und die Zeit nach AIDS2004 in Bangkok

vor allem die Frau Melinda Gates hat schon wieder Aktien gekauft !!!
Mehr gibts dazu nicht zu sagen, Leute. Mich würde mal interessieren ob dieser Michael A. Roth, der Präsident vom 1.FCN ist, kann das einer rausfinden

Gruß werweiß

DIPIERTO, JOHN J.
DIPIETRO, JOHN J.
DIPIETRO, JOHN
DIPIETRO, JOHN D.
DORN, WALTER G. VAN
DOTSON, JERROLD D.
DOTSON, JERRY
DOTSON, JERROLD
DUBE, ANSHUMAN
ENGELENWEG, VAN
EX, NANCY E. KATZ
FINDLEY, MARJORIE M.
FIRESTONE, DAVID F.
FIRESTONE, DAVID
FLUID, ORAL
FOCUS, DAVID F. FIRESTONE MERCATOR
FRADD, BRANDON
FRANCISCO, PARK SAN
FREIMAN, PAUL
FREIMAN, PAUL E.
FRIEDMAN, RICHARD
FUCHS, DAVID
FURLA, GEORGE
GASSNER, HANS
GATES, MELINDA
GAULD, STUART G.
GAVIN, DAVID MUN
GEIGER, BRIAN J.
GEORGE, J. RICHARD
GEORGINO, JEFF
GOLD, KEVIN
GOLD, DAVID E.
GOLDSTEIN, HOWARD J.
GOODFRIEND, DAVID I.
GOODFRIEND, DAVID I
GOTTFRIED, TOBY D.
GOTTFRIED, TOBY
GRANT, CHARLES A.
GREEN, CYNTHIA
GREENBERG, MARK
GREENFIELD, SAMUEL M.
GREENHOUSE, DAVID
GREENHOUSE, DAVID M.
HARRISON, DIAN J.
HARRISONWAS, DIAN J.
HIV, ELISA
HOUSE, CHARLOTTE
INDERIEDEN, ANTHONY
JACINTO, RICHARD
JENETT, BRUCE
JENETT, BRUCE W.
JOSEPH, MARGARET M. STANTON
JUNIOR, LELAND STANFORD
KAFADER, DON
KAMIN, ANTHONY
KATZ, ROBERT
KATZ, NANCY
KATZ, NANCY E.
KEIN, FREIDMAN
KESSLER, DIANA DERYCZ
KESSLER, PAUL
KIEN, ALVIN FRIEDMAN
KIZAR, OSCAR
KLEE, MICHAEL
KLINMAN, NORMAN
KNUTSON, DUANE
KOHLBERG, ISAAC T.
KREVANS, JULIUS
KREVANS, JULIUS R.
KUMBATOVIC, THOMAS J.
LANDAU, MARTIN
LANDERS, DANIEL
LANG, JEFFREY
LEVINE, RALPH
LEVINE, THOMAS J.
LIMIT, GRANT
LIU, CHIH PING
LONG, KAREN
LOW, NATHAN
MAANEN, DICK VAN
MAANEN, RICHARD VAN
MANDELBAUM, AMNON
MARXE, AUSTIN W.
MARXE, AUSTIN
MARYANOV, LINDA
MASSOCCA, STEPHEN J.
MCNEIL, ROBERT D
MITCHELL, MEIER
MONTAGNIER, LUC
MUN, GAVIN DAVID
MURRAY, JOHN
MURRAY, CORALIE EDDY
NONOMURA, HIDEJI
NORTH, LORNE HOUSE
NOVITCH, FRANCISCO MARK
NOVITCH, MARK
O' BRIEN, JACK E.
O' DOWD, SARAH
OSGOOD, RICHARD H.
OYAKAWA, JAY
PALERMO, JOAN
PARTIAL, GRANT
PASSU, PARI
PASTEUR, RAD
PLAN, INCENTIVE
PMB, DAVID COLLINS
PORTER, JEFFREY H.
PRAAG, GEORGE
PROFFITT, THACHER
PUTE, YANG
QUY, ROGER
RANDAWA, ZAFAR I.
RANSOM, BLAKE
REGISTRATION, MARR
RESALES, OFFERINGS
ROBINSON, THOMAS H.
ROGER, GALE
ROSENBACH, GARY
ROSS, GARY W.
ROTH, MICHAEL A.
RUDOLPH, MICHAEL
SAFIN, MARAT
SAFIN, MARAT R.
SANS, PHILIPPE
SCHATZ, STEPHEN P.
SCHENKER, WALTER
SCHRAUB, HOWARD
SERRO, MICHAEL
SHARE, R.E. PROPORTIONATE
SIEGAL, PAUL J.
SIZE, KIT
SLAWSON, STEVEN
SMITH, JOSEPH E.
SMITH, STANLEY
SOLICITORS, NORTON ROSE
SOTOS, TIMOTHY S.
SOULIMOV, MAXIM A.
SPIEGEL, JACK
STARK, BRIAN J.
STERN, GERSHON A.
STREITENBERGER, RUTH
STRIK, CHRISTIAN
SUBDIVISION, PARK
SUYAMA, ROGER
TAYLOR, ELIZABETH
TERMINATION, CONSTRUCTIVE
TONEY, C. FRED
TRUSTEES, CORALIE EDDY MURRAY
TUCK, AMOS
URNOVITZ, HOWARD B.
USDAN, ADAM
VISTA, BELLA
WALLACE, CARTER
WALSH, PATRICK J.
WASHINGTON, GEORGE
WHITE, HELLER EHRMAN
WILLIAMS, CLAUDIE E.
WILLIAMS, CLAUDIE
WILLIAMS, DAVID GREGORY
XIWEN, ZHENG
ZIEGESAR, VON
ZIEGLER, FRANCIS G.
ZURICH, H.U. BACHOFEN

gruß werweiß

phx.corporate-ir.net/...MueG1sP2lwYWdlPTMxMDU3MTMmcmVwbz10ZW5r



Gruß

C.O

Competition
Let’s look at the competitive landscape for Calypte as we go to market with our tests. Looking at the Rapid Blood Test. The major players in the Rapid Blood arena are companies like Abbott, Trinity and OraSure. These are excellent companies who make excellent tests, but if all we were planning to do is to market a Rapid Blood Test I would not be speaking to you today because it’s a very difficult market to do business in. There are over 50 Rapid Blood HIV Tests currently on the market. The price is very low, it’s very hard to make a decent margin on those tests. Calypte – we also have a Blood Test but it really was the first step to developing what we think is a truly unique and innovative Blood Rapid Test that I’ll talk about in just a moment. When you look at the Rapid Oral Test; OraSure, again is the competition. Calypte has developed an Oral Fluid Test and we think it’s a very excellent one. Rapid Urine; we really are the only people out there with a Rapid Urine Test in fact any Urine Test. As I said earlier in the first slide that we are in the process of developing a Rapid Blood Incidence Test. What this test will do; it not only gives you a diagnostic test but, it also gives you the incidence information as well. We feel like this test will be extraordinarily valuable to those countries that need to do epidemiological studies to identify those populations where HIV is being spread most rapidly. It will help us to identify the populations most in need for prevention efforts and subsequently to evaluate the effectiveness of those prevention efforts once they have been in place….

New Product Name
… I am not sure that all of you are aware that our new term – our new name for the Calypte Test is “Aware.” We are going to use this brand name for all of our Rapid Tests in the future…

…Again, we’ve talked about the effectiveness of our tests. The fact that we have now completed our first major clinical study - that study was done in Thailand. It was done by the Thailand Red Cross, and again, the results from those studies were really quite good. If you look at the Oral Fluid data; we tested about a thousand people and we did have a sensitivity of 99.5% which is really quite excellent. Specificity was 100%. Accuracy for that test was 99.8%. Our Blood Test in that study was 100% sensitive, 100% specific and 100% accurate. Looking at the urine data, there’s a sensitivity of 99.0%, specificity 100% and accuracy of 99.6%. This data is unambiguous. It clearly demonstrates that these tests are very, very accurate and certainly appropriate for introduction into the world market, and that is what we’re really focused on right now

Calypte advantage – greater acceptance of testing.
Again, looking at the Calypte advantage - our tests are non-invasive. We have numerous studies that show greater acceptance of HIV testing when blood is not needed, and that really is what it’s all about, is the ability to get people to accept testing and to get into treatment if they need that treatment. We definitely believe that using our Urine and our Oral Fluid Tests, that we can get higher testing rates than is possible using Blood Tests. Certainly it’s easier to use. There’s little training required. The test is performed by unskilled workers. We don’t need phlebotomists or other medical professionals, and it is safer for everybody. There’s no waste at all in terms of infectious materials and no danger for infections for those people who are completing the tests.

Calypte advantage - dominate the blood testing market
Again, looking at the advantage of our test over the competition; with our current Blood Test we really have no real advantage. It’s a “me-too” test. But, that’s going to change as soon as we get the test that I’ve described to you the “Blood Incidence Diagnostic Test” on the market. I really believe that we will dominate that market and that goal will be met. I think fairly soon. As soon as the Blood Incidence Diagnostic Test is completed we will immediately adapt that test for use with oral fluid and hopefully with urine as well

Calypte advantage over OraSure
Looking at the Oral Mucosal Transudate, or Oral Fluid Test; again, our competition is OraSure. We believe that we have certain advantages over OraSure, even though the OraSure test is an excellent test and we certainly have nothing bad to say about OraSure. The OraQuick device is really quite good but our sensitivity as compared to their US clinical trials; we got better results. Our sensitivity is a little higher, our specificity is a little higher, and our cost is lower. Our selling price that we are planning to sell for; we believe is very, very competitive with that of OraSure.
There’s one additional advantage that we think we have with this system, we have of running our Oral Fluid Test and that is that, with the OraSure device; the way it is configured, they collect the oral fluid sample and run the test. The entire sample is consumed in the running of that test. If a person is positive, you won’t be able to give them a definitive answer until a confirmatory test has been run. So, with our test the sample collection is a separate process. We end up with about a milliliter of sample, which is more than enough to run at least two Rapid Tests and if those results are positive you can put a cap on the sample, send it to the laboratory and do an Oral Fluid Western Blot on it. Therefore you’d be able to get a complete answer without the need to draw blood.
The Urine – we have no competition, we are the leader.

The Calypte advantage using a full suite of products that are affordable
Now let me just further say, “Why are we developing three rapid tests?” “Why not pick just one and concentrate on that?” The answer is very simple, we want to give the testing community a complete answer; the ability to do a complete algorithm using non-infectious materials. In other words, alternative fluid other that blood. Our plan is to tell our customers that you can choose. Do you want to screen with urine? Or do you want to screen with oral fluid. If you choose urine, if you get a positive result you can then test that subject with oral fluid. If the two results agree with each other; according to the recommendations of the World Health Organization you can tell that person that they are HIV antibody positive. If those two results disagree, and that will only occur in a very small number of samples, less than a tenth of a percent; you would prick the finger; do a tie breaker using the Blood Rapid Test. We think this is very important, more than 99.9% of people will be able to get an answer without ever having the need to prick the finger or be exposed to blood.
We think that with the way testing is going in the future, it’s going to be essential that people will be able to take rapid tests; go out into the countryside; take testing where people are in most need. The strategy of the VCT - Voluntary Counseling and Testing System of building clinics in population centers, telling people to come to us and we will test you, is a failed technology. So, we believe that we really have the solution.
In developing these tests we were very conscious of two things. We needed to develop tests that were highly accurate. We’ve done that. We needed to develop tests that were affordable. If you have 10 dollars and the test that you’re buying costs $3.00 to $5.00 dollars you can only test 2 or 3 people. If the test costs $1.50 then you can test more people, and that’s what we are all about, is providing a solution so that Public Health has a very effective test at a cost that will get the most people into testing.

Turning our attention to China; again, China has a significant HIV problem. China has recognized that problem and they are actively developing programs to permit them to address that problem. Our plan in China was to form two joint ventures. The first of those JV’s was the Marr Group. The Marr Group is a company that has been doing business in China for about 15 years. They know the country. They know the people. They know the markets. They’ve been extremely helpful to us and will be our marketing partner for the Chinese Venture. We also developed a Joint Venture with Tiantan Biologics in Beijing. This JV will be the manufacturing arm of our efforts there. We have started the process in China leading to a launch of the product in the second half of 2005. We’ve set up a small manufacturing facility and made product for clinical trials. Clinical trials will begin in China this month. The trials will be completed by the end of 2004. We will submit our data to the SFDA in January of 2005. The SFDA, because we are considered to be a Chinese company, due to our Joint Ventures, will give us what is called the “Green Light Pass” through the regulatory process. On this path, they have a regulatory requirement to respond to our application in 90 days. We’ve padded that a little, but just to give us some cushion. We are predicting that we will have an answer from the SFDA by July 1st of 2005. We could then launch into the Chinese market the second half of 2005. The factory we are building in China will have an initial capacity of about 50 million tests per year, yet, that factory is expandable to 100 million in 6 months, if required.
Backing up to Thailand just a minute; the initial capacity for Thailand is estimated to be about 15 million; again, expandable within 6 months to 30 million if the need is there.

Looking at the China opportunity, I’ve told people many times, “There are no small markets in China.” Just looking at pregnant women for example; each year 50 million pregnancies occur in China. Each of those women are required to have a HIV test. Sex workers in China are registered. There are approximately 30 million sex workers in China that require testing every quarter. So, four times 30 million is 120 million people. So, again, we will be working very hard to penetrate that market. And that gives you some idea of the size of the markets and what a minimal type of penetration will give you in terms of sales in China.

Developed Country Strategy
We also have a developed country strategy. A vast array of aggressively defended or un-acquirable IP and Patent rights is really the state of the business in the United States for lateral flow assays. The IP portfolio of a company really determines freedom to operate and where they can operate. The IP portfolio also defines the scope of the market and the size of the opportunity.
I am very pleased to announce to you that we have completed all of our IP acquisition efforts and we have all of the intellectual property that we need to be a global diagnostic company, and we can now compete on a worldwide scale.
Looking at the IP challenge that we have addressed in the past year; there’s a company in the United States by the name of Inverness, who bought up all of the lateral flow patents and as a business strategy, refused to license to anyone. So, we had the need to find a way to get around those patents. Looking at the next slide you see the final piece of that puzzle was Ani Biotech. Ani Biotech was making pregnancy tests in Europe, they were sued by Inverness and had to withdraw their product from that market. They set out to find a solution, and they did find a solution, it was the use of the technology that I’ll show you in just a moment. But just let me say that now we have obtained from Ani Biotech an exclusive license to use Oral and Urine Lateral Flow Platforms for HIV 1-2 Test, Hepatitis, HPV, Syphilis, Gonorrhea and Chlamydia. We also have obtained a non-exclusive license to use Blood in their Lateral Flow HIV 1 and Hepatitis and other sexually transmitted diseases. Looking at the Ani Platform, the real key to that is that they have taken the sample pad colloidal goal and wrapped it onto the stick. You see the red tape covering that. This transforms the test into a two step lateral flow assay instead of a 1 step. The one step platform was the first Lateral Flow Platform developed. It was patented at the time, but those patents have expired. We have, of course, opinions that we can operate using this particular platform….
…We do have exclusive license, we do have now a very strong lateral flow platform that we plan to use to develop a very complete line of infectious disease rapid test diagnostics.

The big picture
Looking at the big picture, looking at the projected timelines that we’ve talked about, just to, sort of summarize. We will commence clinical trials by 2004 and have them completed by the end of January of 2005. We’ve already done one trial in Thailand, we’re about to start another in China. We are making plans and will do clinical studies in Africa. All of that is underway or done and will be done on the time that we have outlined. We plan to submit applications for approval to the Chinese FDA again in January of 2005. We plan to begin USFDA submission process in the United States in July of 2005, and we plan to launch our product into Africa the first half of 2005 and into China the second half of 2005. We are also looking at other opportunities. We plan to definitely follow through on our promise to our shareholders that we are going to commercialize the rapid HIV Test Suit in 2005. We are poised to do that. I’ve already gone through all of that with you. We’ve done an awful lot this year and we will hit the timelines that we have described. We have other products in development. I will not be distracted from the commercialization of our current tests, but it would be irresponsible for me not to be thinking about the future beyond the commercialization of these tests. Our plan is to plant things in the pipeline, ready to come to market as we move forward. So, that’s where we are, in terms of the products; our plans to commercialize. And I have to say that all of the people at Calypte have worked very hard in 2004 and we have accomplished an awful lot, and I hope that you agree with that.

Rick Brounstein CFO
Profitability Timeframe
…Now looking forward. We really see profitability now with the Rapid Tests coming on conservatively in the first half of 2006 and Richard and I have debates and he really thinks it will be more like later in 2005 and truly it’s hard for me to argue with that. Let me elaborate. Now there’s been some confusion about what our margins would ultimately be on the Rapid Tests. In the initial markets, taking into consideration the competitive landscape, the fact that we would rather not disclose our cost of goods and royalty structure to competitors, in further calculating a blended rate of the highest ASP and the highest margin along with the lowest ASP and lowest margin, we feel comfortable saying that our mean margin on each unit sold to the initial markets would be approximately 50 to 55 cents per unit. Based on today’s burn rate of a million dollars a month, which by the way, we see dropping considerably into the up coming year we could achieve profitability based on that margin with a sale of 20 to 24 million tests. Based on the size of the markets that we are entering into in 2005 we would need minimum penetration to achieve those results. We therefore feel comfortable representing our belief that the company will be able to reach profitability by late 2005 or early 2006. And as Richard noted we will have capacity for over 50 million tests for our initial manufacturing sites in Thailand and China. We can ramp those up to over a 100 million in 6 months as demand warrants.

Dr Richard George, President and CEO
Conclusion Summary
I’d just like to finish up by giving you the same type of overview of the business. In January of 2004 we had a product line that was limited to the legacy product, and then, validated rapid test platform for blood and urine. Right now we have a product line of Rapid Oral, BED, Incidence and the Ani platform for STD’s. We have a real platform here and a real pipeline that is going to continue to add tests to our product line. Some of these tests have a market size that is even larger than HIV. We had in January a slim IP portfolio limited opportunity to developing countries. Now we have IP and licensing completed with freedom to operate globally. We had invalidated technology, now all of our tests are fully validated, and we are ready to go to market. In January of 2004 we were not even able to produce test kits for China for clinical trials. Now clinical trials have been made, they’re ready to go and clinical trials are starting in November of this year. Rapid products were invalidated “me-too” kinds of products that with 100% accuracy, with confirmed feasibility of innovative Rapid Incidence Technology, and we have what I think is a truly new innovative type of Rapid Blood Test coming in the so called Diagnostic Incidence Test. We had no products for the African market, now we’re poised to launch into the African market the first half of 2005. We had no commercial scale manufacturing capacity, now we are 2 months away from commercial scale manufacturing. I hope you can appreciate that most of this was accomplished by very hard work in 2004 and I just want to conclude today’s broadcast by saying that, again, I don’t think the company has ever been in better shape than it is right now. We have products, we have manufacturing to be completed, almost very eminently and we are headed toward, I think, a very exciting 2005.
Let me thank you for both myself and Rick for calling in this morning and I certainly hope that this overview has been useful to you and that you really do understand where we stand as a business.
Thank you, very much.

liest sich sehr schön, wenn sie denn dann auch mal taten folgen lassen.

die chancen sind aber in der tat besser geworden, nachdem cataldo weg ist...

die angst davor...

RT´s

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an der us börse sackt der kurs heute ein, ich frage mich warum. weiss jemand von euch, was da los ist?

Wasn mit dir los ;-)

Kurs sackt wieder ab, weil aktuell immer noch Aktien im Wert von 16,5 Mio $ ausgegeben werden sollen.

jeder weiß, was kommt....

wieder kurse um die 0,20$

schöne grüße an den nichtsblicker bernd: "ja, ist es denn die möglichkeit..." alias possibility

denn das ? Weit über Parität !

wollte, sich aber vom vielen posten im calythread mit der wkn vertan hat. ;O)

*gg*

bald sind wir wieder unter 0,01. womöglich heute noch. sammel noch ein paar mails, dann wende ich mich an die SEC...dem kerl sollen sie die eier langziehen und die vorhaut über den kopf.

und caly? auch wieder mächtig im plus heute? was habe ich euch gesagt: ihr seht die 0,30 wieder von unten "aus sicherer entfernung".

nirgendwo ist der beschiss so offenkundig wie hier


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bin ich schon 439 tage angemeldet?! die zeit vergeht, habe mein passwort vergessen ;-)
hast dir sogar die mühe genommen, die tage auszurechnen, schmunzel, aber das können wir ja, mit zahlen umgehen, meine ich. (hoffe ich wenigstens)

zu caly:
werde wohl mit kaufen noch etwas warten, denke aber, es könnte wie alstom herauskommen, ist evtl. bei 0.2 USD bereits wieder einstiegszeit.