Calypte und die Zeit nach AIDS2004 in Bangkok
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WKN Börse Kurs Trade Vol. Tages Vol. Zeit Datum Bid Bid Vol. Ask Ask Vol. T.hoch T.tief Vortag Diff. Änd. Realtime
676390 FRA 0,320 5.500 485.590 19:22 12.11. 0,320 0 0,330 0 0,400 0,220 0,234 0,09 +36,75% ja
schwarzer freitag für meine kritiker...nein...ich weiß augrid...jaja. abwarten, da kommt auch noch was...
Zitat Joelü
Ihr calyunbelehrbaren seid ein ganz eigenes, unverbesserliches, uneinsichtiges und "niveauvolles" Volk. Nirgendwo anders habe ich eine solche Spezies angetroffen, wie hier.
Ende 2004 unter 0,20$. Mein Wort steht!
Aber die Ursache siehst du nicht, kannst und willst du auch nicht sehen. Schau dir mal an, wer sich in den letzten Monaten schon aller schwarzen Sterne abgeholt hat. Wer nicht fähig zur Diskussion ist, hat es einfach nicht besser verdient. Ihr calyunbelehrbaren seid ein ganz eigenes, unverbesserliches, uneinsichtiges und "niveauvolles" Volk. Nirgendwo anders habe ich eine solche Spezies angetroffen, wie hier.
Ende 2004 unter 0,20$. Mein Wort steht!
Mein ernst gemeinter rat!!!!
wie sagt dr. Odo- brumme immer: truth is stronger than fiction
Das schlimme ist: es wird so kommen!!!!!!!
also voricht !!!!!!! Finger weg. lass dich nicht blenden von leeren Versprechungen, lass die Hardliner schreiben, dass sie 100.000 stücke nachkaufen oder wie viel auch immer, aber lass dich nicht in die scheiße reiten...
In wenigen Tagen werde ich auch 19000 Stück nachkaufen. Je billiger sie bis dahin werden, umso besser ;-) Ich bin mir nämlich im Gegensatz zu vielen anderen hier auch sicher, dass ich bei Calypte den $ (ohne RS) wieder sehen werde. Und wenn das noch bis 2006 dauert, kann ich es auch nicht ändern. Aber dann hab ich so richtig profitiert ...
Wo werden Produkte Calyptes verkauft?
In den USA verkauft Calypte seine Produkte direkt an prüfenlabors HIV. Calypte hat auch Verteiler für einige oder all seine Produkte in zahlreichen Ländern um die Welt ernannt, und seine Liste der Verteiler wird ständig erweitert und verbessert. Zusätzlich zur Zahl der lokalen Verteiler um die Welt, hat Adaltis Inc. non-exclusive weltweite Vertriebsrechte für westlichen Fleck des Serums Calyptes.
......... wenn ich in Deutschland ein Test kaufen möchte wende ich mich an den Verteiler und nicht an Calypte, leider meldet sich kein Verteiler bei Anfragen wenn es sie überhaupt wirklich gibt!
Deine Postings von Beginn an zurückzuverfolgen.
Jeder kann somit sehen, wie Du immer wieder provozierst und es darauf anlegst, dass dich jemand schwach anmacht.
:-) Immerhin hast du unheimlich viel Zeit um vor dem Computer zu sitzen.
Mein lieber Gefährte Jöelü,
Wie erklärst Du dir die negativen Töne, die in sämtlichen Threads immer erst im Vordergrund zu hören sind, sobald Du auftauchst???? Ist schon komisch, oder? Dazu kann Dein Fan Calyritter und Joenrw sicher auch nichts zu sagen.
Ich habe mit meinem Freund dem Facharzt für Psychotherapie darüber geredet, wie und wann sich so Menschen verhalten, um aufmerksam zu werden.??
Joelische Prophezeiungen
Eure Ignoranz kennt keine grenzen. kein Fettnapf ist zu klein, als dass ihr nicht reintretet...
Calyritter hat nicht angerufen, sondern ein Mail geschrieben. Wisst ihr genau was er geschrieben hat? Aber eine antwort in irgendeiner form kann man schon erwarten oder?
Ihr labert euch froh, dass ist nicht zum aushalten. es gab in der dt. Geschichte schon mal eine zeit, als alle etwas blind und vorbehaltlos glaubten...das ende und somit böse erwachen ist euch auch bekannt...
Wenn caly plötzlich Tierfutter verkauft, findet ihr garantiert auch noch eine positive Erklärung dafür, oder?????? "Ahhhhhhhhhh, Produktdiversifikation....sehr gut, damit geht es aufwärts..." lach, prust...
Guten Wege...davon entfernst du dich zusehends???
Die frage, warum caly so abgestürzt ist, begründet sich in den grottenschlechten Umsatzzahlen!!! Im letzten filing steht, dass dieses Jahr keine grossaufträge mehr zu erwarten sind. Also wird kein Geld oder nur sehr wenig mehr reinkommen. Somit hat man im neuen Jahr auch kein cash mehr, um seine kosten zu decken. darum die Ausgabe neuer Aktien.
Reliably - caly ist bei dem mini-jahresumsatz immer noch überbewertet. Man möchte gerne ein globalplayer werden, verbrennt aber seit Jahr und tag nur die kohle der investierten!!! Vorsicht mit solchen aussagen, wenn jemand sagt, er kauft noch mal 35.000 nach. So naiv kann eigentlich gar keiner sein, dass er sein komplettes erbe oder was auch immer auf spiel setzt!!!!
Schaue dir an, wie viel neue Shares im Dezember kommen!!!!
Was rechtfertigt den jetzigen Kurs von 0,23?????????? nur weil es optisch billig ist. Nun gut, eine gewisse technische Gegenreaktion wird es immer mal geben, aber die 10 -15% genau abzupassen ist sehr schwer. Da gibt es bessere werte zum zocken.
Den $ werdet ihr nur noch nach dem nächsten RS sehen, wenn überhaupt. Dieser RS wird, so denke ich nächstes Jahr kommen. Neue Aktien muss man auch deswegen ausgeben, um die mk von 50.000.000 $ wieder zu schaffen. ein Mindestkriterium für eine amex-zulassung, wenn das kurs-kriterium schon nicht erfüllt wird...
Ohne Umsatzzahlen und darauf warten die verprellten und blinden nun schon seit 3 Jahren, wie der Kurs auch nach dem nächsten RS wieder absacken. So ein geblende, wie im Sept. 03 wird es so schnell nicht mehr geben, da sich die meisten blaue Augen geholt haben.
Die mk beträgt aktuell: 169.000.000 x 0,23$ = 38.870.000 $.
wofür?????????? Für Jahresumsätze, die nicht mal die 4.000.000.000 grenze berühren und massenweise Verlust???? Zurzeit habt ihr ein KUV von 10!!!!!! wofür????? Ein kuv von 2-3 wäre wohl eher gerechtfertigt. Das hätte dann eine mk von 8.000.000 - 12.000.000 zur folge bzw. einen Kurs zwischen 0,07 und 0,047!!!
Diese Kurse gelten natürlich nur, solange wir bei 169.000.000 Aktien bleiben. Steigt die Aktienzahl bei bleibenden schwachen Umsätzen, geht der Kurs noch weiter nach unten.
Er hat sich ( Der Freund von mir, den ich genannt habe ) ein Einblick verschafft, von dir in dem er auch ein paar Mal deine Beiträge gelesen hat mein lieber Gefährte Joelü, : ) )
Ich werde es so ausdrücken : nimm meinen guten Rat und lass dir Helfen, lass dich in die arme eines vertrauenswürdigen fallen, versuch gewisse Geschehnisse zu verstehen……
Es soll wie in einem warmen Bad sein ………
Gruß
Dein
C.O
Einzige was passieren könnte ist das ein Investor wieder in Caly Investiert und innerhalb Wochen der Kurs sich verzehnfacht aber das Risiko ist zu Hoch ........ bei 5 - 8 Cent Zocke ich mich nochmal rein.
Bis dahin Viel Spass den anderen :)
cardero ist sicherlich der bessere pick, womöglich stosse ich auchnochmal zu euch...
broker: deine kritik mutet an, wie das letzte verzweifelte winden und zucken. unter 0,20 seid ihr sogar schon am freitag gewesen...
aus dem aktuellen filing
seite 16 unten:
OVERVIEW AND OUTLOOK
Since 1998, following FDA approval for both the current ELISA screening and
supplemental tests, Calypte has been marketing and selling in the United States
the only available FDA-approved urine-based HIV testing method. We have received
regulatory approval to sell our ELISA tests in China, Malaysia, Indonesia, and
in parts of Africa. Unfortunately, these laboratory-based tests have not
received significant acceptance in those markets. We believe that there is a
small established market for our current ELISA tests in the United States and a
potential market in certain foreign countries with established medical
diagnostic and treatment infrastructures, as well. We believe, however, that
rapid tests are more suitable in many of the countries in which HIV/AIDS is
epidemic, and particularly so in sub-Saharan Africa and the "next wave"
countries of Russia, China, India and in northern Africa. Consequently, we are
now actively working to commercialize our HIV rapid test products and to obtain
requisite regulatory approvals to introduce these products in these countries,
as well as in other international markets. There can be no assurance that we
will achieve or sustain significant revenues from sales of HIV diagnostic tests,
internationally or domestically, or from other new products we may develop or
introduce.
seit 17 oben:
CALYPTE BIOMEDICAL CORPORATION AND SUBSIDIARIES
We must achieve profitability and sustainable cash flows for our business model
to succeed. To the extent that we have not yet achieved these objectives, we
must continually evaluate both our current and long-term business plan and
capital requirements. While the validation of our business plan is ongoing, we
have identified and begun to implement certain critical components:
...Although we do not presently have any agreements in
place with respect to additional financing, we intend to seek
additional financing aggregating up to $16.5 million by the issuance
of Common Stock or equivalents and/or the issuance of warrants to
purchase shares of Common Stock on terms and conditions that, based
on the current market price of our Common Stock and the size of the
financing, may result in the issuance of more than 20% of our
currently issued and outstanding Common Stock and/or that may
trigger certain anti-dilution protections that are included in
existing financing agreements or that may be included in subsequent
financing agreements and that would result in substantial dilution
to existing stockholders. Under the rules of the American Stock
Exchange, in the event that either of these conditions occurs as a
result of a prospective financing, we would need to obtain
stockholder approval of such financing. Although we filed a
preliminary proxy statement with the Securities and Exchange
Commission on October 29, 2004, in furtherance of seeking such
approval, we have determined not to proceed with that preliminary
proxy statement and proposal and intend to file a new preliminary
proxy statement, if required. There can be no assurance that we will
enter into such agreements or secure such financing, or that we will
obtain stockholder approval, if so required...
...
Guidance We project full-year 2004 revenue from the sale of our current ELISA
tests and the BED Incidence test to be in the range of $2.6 million to $3.2
million as our reference lab customers continue to rebalance their inventories
following accelerated purchases in the second quarter during our transition of
EIA manufacturing from our former Alameda, California facility to our Rockville,
Maryland location.
jahresumsätze gerade mal 3,2 mio-$. wow.....das verbessert das KuV auch nicht gerade.
realistischer wäre ein KUV von 3!
das heißt: 9.600.000 (jahresumsatz x 3) : 224.000.000 (die bald neue anzahl der aktien) = 0,0428$ fairer kurs.
viel glück broker, mit allen therapeuten und sonstigen helfershelfern der welt, die dich noch in deiner meinung unterstützen. muhahahahahaha...
zu eurem $: ihr müsstet bei der neuen wenge an aktien ca. 74,66 mio-$ umsatz haben, damit eure $ bei einem KUV von 3 gerechtfertigt wäre.
nach einer kleinen gegenreaktion, die bald mal kommen kann, wird es euch weiter in den finsteren keller ziehen...
da ich nur begrenzt meine Zeit deiner Wenigkeit opfere will ich mich nur nochmal wiederholen.
Nimm Professionelle Hilfe an, es wird dir gut tun.
Ich mein es nur gut mit dir ,so wie du versuchst gut zu uns zu sein.
Nur mit einem unterschied , wir sind uns im klaren was auf uns zu kommt.Du nicht.
Ach noch was mein lieber , unsere Anlage wird Früchte tragen deine wohl nicht mehr.
Tut mir leid es klingt komisch aber es ist die einzige Sprache die du verstehst.
Im SEC File stand, das vieles in Q1 2005 in gang gebracht wird. Das ev. Fusionspartner in Erwägung gebracht werden könnten. Wer könnte es wohl sein ? Abbott , Phizer , Bio Rad usw.
Marr ist bereit zur finanzieren, Wenn Marr an die Mehrheit der Aktien kommen könnten welches womöglich der Fall ist , dann werden wir einige der Direktoren bei Caly nicht mehr sehen. usw.
Naja , also mein lieber joelü unser Unternehmen ist mit voller Überraschungen ..
Diese und weitere Geschehnisse könnten genauso kommen wie alles andere auch..
dein letztes posting hast du doch aus 2002 oder 2003 hervorgekramt, oder?
das gleiche gesülz habe ich schon 1000 mal gehört.
"Ich mein es nur gut mit dir ,so wie du versuchst gut zu uns zu sein.
Nur mit einem unterschied , wir sind uns im klaren was auf uns zu kommt.Du nicht."
junge, prust.....du hast ja wohl zu heiß gebadet was...?
"Ach noch was mein lieber , unsere Anlage wird Früchte tragen deine wohl nicht mehr.
Tut mir leid es klingt komisch aber es ist die einzige Sprache die du verstehst.
Im SEC File stand, das vieles in Q1 2005 in gang gebracht wird. Das ev. Fusionspartner in Erwägung gebracht werden könnten. Wer könnte es wohl sein ? Abbott , Phizer , Bio Rad usw."
irgendwie meine ich, diesen stuss einmal jährlich zu lesen. das wurde euch schon in den vergangenen jahren versprochen...
oooooooooooooooooooohhh mannn, armes deutschland...
abbott, pfitzer, bio rad....tzztztztztzt
höchstens abort, spritzer und rad-ab übernehmen diese seuchen-bude...
immerhin ist die seuchenbude im plus heute. 5%!!!!
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glaubst ja.wenn nicht nein. so einfach sollte es fr dich sein. caly ist ein wert, an den glaubt man oder lässt die finger weg. October 28, 2004
Richard Brounstein, CFO
...For 2005, is first, working with the CDC regarding wider use of the Incidence Test and second, the launch of the Rapid HIV 1-2 Test. Our expectation is that the first rapid sales will come from Africa or Southeast Asia in the first half of 2005 and China in the second half of 2005…
To complete the consolidation of our manufacturing operations we are producing pilot lots of EIA in Rockville, performing compatibility studies and preparing for FDA approval of our manufacturing facility, expected in the spring of 2005.
In the interim we would be in the position to manufacture product for international sales should the opportunity arise. Further we built significant inventory to insure a smooth transition for our domestic insurance customers. To be conservative in the absence of new international orders we have reserved approximately half the value of the EIA inventory in the third quarter of 2004 and our current supply exceeds demand for the insurance business alone. We will also look for opportunities to utilize this inventory and enable cost effective AIDS testing as appropriate such as programs with local AIDS groups. These programs could build goodwill with organizations that are being exposed to Calypte for the first time with the hope that it could build interest in our Rapid Test platform in the future.
The dollar spending was reduced proportionately more than the change in sales as we have leverage now. We manufacture all the legacy products from a single manufacturing location and have adequate growth capacity as the Incidence Test business expands and as we start to prepare the facility for the production of the Rapid Tests using the just acquired Ani platform. Make this point very clear, we completed this consolidation essentially without adding any head count in Rockville manufacturing. We have reduced our by-weekly payroll by approximately $40,000.00 a pay period. We also consolidated EIA product line into Rockville without adding one square foot of manufacturing space. We eliminated all of our fixed costs from our Alameda facility including base rent of over $30,000.00 a month as well as related building and manufacturing overheads. This savings reduces our cash burn by over a million a year. This is critical as we expand our R&D efforts and continue to invest in rapid diagnostic testing marketing.
Turning to the balance sheet, we believe we have adequate resources to continue executing on our current business plan into early 2005. This plan focuses around the development and commercialization of a line of rapid diagnostic tests initially HIV 1-2 tests and in the future without current IP platforms more complete line of STD tests such as syphilis or hepatitis. Our plan also includes sustaining a profitable lab based HIV testing platform consolidated in our Rockville Maryland facility now essentially in place as I was discussing earlier.
We closed the quarter ended September 30th with approximately 4.5M in cash compared to 5.1M at the beginning of the year and 6M last quarter. During the third quarter we completed a private placement of our common stock with institutional accredited investors received aggregate net proceeds of approximately 1.4M. Additionally we completed a vendor leasing transaction with VenCore to finance approximately $400,000.00 of the capital expansion costs of Rockville, we consolidated this into a three year lease. Further, while we do not see the Marr Credit Facility under which we could borrow, being a long term solution, as payments are due on May of 2005, it would, subject to unanimous board approval, provide an additional 3.6M from promissory notes that we could issue through the end of December of this year.
The goal of any proposed PIPE financing is to raise additional cash to provide the necessary resources to finalize the commercialization of our HIV 1-2 Rapid Tests. We expect the profits from the Rapid Tests will then provide the positive cash flow to grow the business under the current plan without the need for additional funds. While there are always uncertainties in running a business, we are far enough along in the development of the HIV 1-2 tests to confidently believe we have mitigated the significant risks within our control. While we plan to move forward with other developments such as developing other STD tests and entering the US market, we non-the-less believe this financing will permit us the flexibility to manage the business and adjust the timeline on new programs with the realities of the regulatory environment that our products live in.
We look forward to the impending day which we will no longer have to rely on the capital market for money but rather utilize them as a partner for realizing stockholder value. We believe that this day is drawing near. We intend to achieve financial stability to meet our stated goals.
To re-cap we are quite pleased with the progress that we are making. We have maintained a strong cash position of approximately 4.5M, enough to continue our current business plans and investments into early 2005. We have established a financial position and implemented corporate governance standards that enabled us to begin trading on a major stock exchange, the AMEX this past August. We are using this financial base and progress in our rapid diagnostic testing business as a catalyst to a successful future. To achieve these plans we filed a Proxy today to seek approval to raise the necessary capital for 2005 and beyond. That process is underway and most importantly with product launches anticipated over the next several quarters we expect to begin to achieve our long term goals of sustainable growth and profit.
Dr. Richard George, CEO
The acquisition of the license from Ani announced October 5th gave Calypte a rapid test platform that we and our attorneys believe is free from any restrictions. The new rapid test platform is to be the foundation for our rapid test line of products. Also included in the deal with Ani was fully automated production equipment to be installed in Calypte Rockville Manufacturing Facility. The acquisition of the HIV 2 patents effective September 28th makes it possible to make and sell HIV 1 and HIV 2 assays worldwide. The acquisition of the HIV 2 license is one of the final IP acquisitions to allow Calypte to operate on a global scale. Following this event we immediately began working with Ani staff to transform our existing assays into the Ani format. We also began identifying assays for other sexually transmitted diseases that we plan to license or develop for the Ani platform. Equally important in Ani, we have an important partner for new research and manufacturing. After conversion of the existing HIV test to the Ani platform, the first totally new product in the Ani format for worldwide distribution is likely to be the Rapid Incidence Test slash Diagnostic test. That assay is under development in collaboration with the CDC through our Cooperative Research and Development Agreement. That work has been going on for approximately eight months. We believe that we have demonstrated feasibility for that product. There is still work to be done before it’s ready for market. I remain firm in my belief that this test will be truly revolutionary in the HIV Rapid Test market. For one price, public health agencies can learn in approximately 20 minutes whether a person is HIV antibody positive and whether a person is a recent infection or one that may have been contracted months or years ago. I believe this feature will strongly distinguish Calypte’s rapid blood product in a “me-too” market and will make Calypte the preferred blood rapid test worldwide, a test with the same price as other tests but with stronger diagnostic ability. I want to emphasize one very important fact; these events are, in my estimation very positive developments for the future of Calypte, and I want to reiterate that I do not believe that they will in any way distract us from our goal of making and selling our current HIV Rapid oral fluid, blood and urine assays on the schedule we have previously outlined for our investors.
Let me update you on the critical progress on that front. First China; Calypte employees have been working have been working very diligently in China in preparation to begin clinical trials. A contract is now signed to conduct the trials. Assays have been produced, packaged and are awaiting the beginning of the trial. The training of personnel who will conduct the trial has been completed and our contractor has begun preparation to collect and test samples. Testing is scheduled for completion by the end of the year, and we continue to expect to submit the application for approval to the Chinese SFDA in the first half of 2005. We also believe that all of the review approval and other administrative tasks can be completed on schedule. That will allow for product launch in China during the second half of 2005.
Thailand
Our work in Thailand also continues Calypte personnel are currently in Petcha Boon working with our manufacturing partner Pacific Biotech to complete the technology transfer. We believe that product will be ready to be shipped from that facility this year or early in 2005.
Now let’s talk about progress in getting sales started. As I have told you in the past, there are processes that must be completed before significant sales can occur. The processes vary based on the territory or country involved but despite a-symmetric regulatory paths we continue to execute the necessary task as quickly as possible. For example, some countries have established regulatory processes leading to approval and sales. We have begun the approval processes in China and are on track to begin in Thailand, South Africa and we are evaluating other countries as well. Some developing countries have less rigorous processes or no regulatory agencies. We have identified certain of these countries and we are actively seeking sales. We need to also satisfy the requirements of large donor agencies, such as the CDC, WHO, USAID, and the World Bank so that they can consider our products. Efforts to accomplish this task are in the early stages, but have begun.
Our first products for the international market will come from our Thailand Manufacturing Facility. In a anticipation of availability the first quarter 2005, Dick Van Maanen, VP of Operations has been on the road several weeks now setting up distributors, training existing distributors, and meeting with government officials. The effort has produced some very positive results. Our distributors are optimistic and through them we are investigating upcoming government tenders.
On the Incidence front, I have discussed in our previous call that we anticipated we would have product ready for market in August of 2004. In fact, the first lots were not released for sale until September. We have a policy that precludes us from shipping products internationally until we have received payment regardless of the purchase order in hand. We have received the initial payment for the first of these orders; forty kits, and shipped today. Currently we have purchase orders from three countries around the world. While these numbers are not exceptionally large in the aggregate, they none the less represent a strong display of interest for this new and innovative technology. We expect the BED Incidence test to be an important contributor to our going forward. The product requires no additional fixed overhead. It is manufactured in our existing Rockville facility with current man power. It has been a privilege to work with the Centers for Disease Control and Prevention to make this test available and we will continue to work with that prestigious agency to train people in its use. We certainly do not underestimate the significance of having a collaboration with the CDC. This is just the beginning of our expectations for the Incidence Test. Over the last few months the CDC decided that they will support the implementation of the Calypte Incidence Test in the United States and in international settings through the Global Aids Program referred to as GAP. CDC is training many countries to use this test and is developing guidelines for how the test should be interpreted and the data used to identify populations where HIV is being most rapidly transmitted. Currently we are aware of six workshops planed around the world to train public health officials to use this new technology. In addition, there will likely be a PEPFAR, or Presidents Emergency Plan for Aids Research proposal to support the use of the Incidence Test in three additional countries, although this has not yet been finalized. Additionally, people in several other countries have trained and may choose to proceed with the use of the Calypte Incidence Test whether or not they are included in the PEPFAR proposal.
In conclusion, the past quarters have produced, in my opinion, a great step forward towards fulfilling all of the mutual hopes, expectations and aspirations for Calypte. We were able to address and resolve our most daunting intellectual property challenge to date by signing critical licensing deals with Abbott Labs, BioRad and Ani Biotech. We have begun transforming our existing assays into the Ani platform and identifying other STD assays that will use this powerful platform. We launched and began shipping our BED Incidence Test, which shows promise to be one of the most innovative technologies in HIV testing. As we convert this test to a rapid format through the CDC craita, this will allow us to distinguish our rapid blood offering amongst a cluttered and rarely innovative market place for rapid blood products. We have moved the Chinese clinical program forward, whereby we now await the trials initiation in the very near future. We also remain on track to file for approval in China in the first half of 2005 leading to a launch in the second half of 2005. The Thailand facility nears completion of the technology transfer and gets closer to being able to produce product that will initially supply the African launch in the first half of 2005 and we have moved the regulatory process forward in Africa and other prospective countries. Make no mistake, this is progress, and value by any standard and I hope that you are exited about as I am.
We have come a long way in 2004 and despite the growing pains of an emerging company I can’t help but be satisfied with the progress of the past and the prospects for our future. I have done this before from both sides of the table. I was a government scientist and program administrator for thirty four years. I helped to develop and introduce OraQuik into the market while I was at OraSure Technologies. Since I was given the opportunity in January of this year to lead Calypte, I have told you where we are going and how we were going to get there. I’ve given you timelines for significant events. To meet these timelines we often must deal with governments and other agencies that are large, complicated, and not prone to move quickly. For that reason we have not always hit the timeline right on schedule, but we have been remarkably close and from my experience when you look back at these kinds of events you tend to forget the incremental slippage. This is likely to be the situation going forward, I hope that all of you will choose to stay the course.
Question and answer session…
Al Kildony with FF Capital
Q. Can you give us an idea what pricing looks like on this test and then a little more granularity on how big of an opportunity the Incidence Test presents to you?
A. Yes, your first question was about pricing and we are pricing the test, of course based upon the number that a person orders. Our pricing starts at $3.00 per test and goes down to about $1.50 if you order very large volumes of those tests. The kits are currently configured as a hundred and ninety two tests per kit, and, how many are we planning to sell? You know, I want to emphasize several things about that. I don’t want to create an undue or an incorrect expectation among investors. This test is for surveillance purposes and since that is the case, we have been able to bring this in from the CDC through a Materials Transfer Agreement, so, we were able to do that and avoid all of the expenses that one would naturally incur in doing the research and development and evaluation and the validation of that assay. We were able to take it from the point of acquisition to manufacturing in just a very few months.
The sales of this test are going to grow as people become aware of the fact that it is in existence. It is a totally new product, not previously on the market, and we are very fortunate that it is an integral part of the CDC prevention strategy. Therefore, they are being of immense help to us in training people to do this, teaching them how to use it in their prevention programs. It’s going to be kind of a growing process, but I believe that over the next year or two years we will be selling probably, I’d say, by the end of year two maybe 5 to 10 million of these tests per year, and I think that’s probably the size of the market. It’s not as large as rapid tests, we don’t expect it to be anything like the business opportunity of our rapid test business, but it is a very good business and our margins are quite good and we’re very pleased with the progress that we are making with that.
Q. On the China front, your update there was helpful. I wanted to get a little more color on the status, specifically of Chinese manufacturing and then your plans with regard to the joint venture where that stands?
A. the process of getting markets started, we have not yet started to construct the facility, it is an existing building. We’re going to be doing just a renovation of that building. In terms of the J.V., those talks continue to go on. We’re very close to finalizing that particular agreement. We do not anticipate that the leisurely pace we’ve taken with this is going to in any way delay the launch in China. It’s just that we’ve had time. I mean, we still have time. We have to go through these other things and there is really no reason to spend your funds on that till you have to. So, we’re very happy with the way things are going, and we’re going to be ready with manufacturing in China when that approval comes from the SFDA and..
Q. Do you expect a similar time frame for the technology transfer process as you’ve seen in Thailand?
A. I actually think that it will be better than we’ve done in Thailand, because, remember this is our factory and I have the option of putting our people in there. We have already started to select our staff we will start the training in advance of the time when we get approval. once we have completed the clinical trials in China, you know, once we see what the results of this clinical trials are we’re going to know that approval is either going to be coming or it’s not going to be coming. Cause we know what we have to achieve, in terms of performance. So, again this is all planed to be done concurrently with everything coming together before the time when we have the ability to start selling in China. If we can get the process done earlier, we might consider some exportation from that facility.
Q. Great! And so just to also clarify, in Thailand your close to completing technology transfers, does that mean some time by year end you’d actually be in a position to begin commercial manufacturing?
A. Yes.
Q. Great! You mentioned in your presentation that there are certain requirements that you must satisfy for the donor agencies for the performance of the test, and I wonder if you might be able to give us some idea what kind of requirements they might have? or how rigorous they are?, and then also, if you could also shine some light on what kinds of discussions or dialogue you continue to have with those organizations as you prepare the company for launch of the commercial test?
A. Let me just first say, the reason that we haven’t done more in that area than we have done is that we have to have manufacturing set up and making the product that these agencies will evaluate has to be coming out of our actual manufacturing facilities. Now I’m talking specifically about the organizations like WHO and CDC and USAID, so we have had discussions with WHO and considering our past history with WHO I don’t want to get in trouble with them, but we have had discussions with them. They have agreed to do the evaluation as quickly as possible. In fact, they’ve even called to check on our progress. They not only are willing, they’re actually anxious to doing the evaluation. So, as quickly as I can finish up in Thailand and get product that’s coming out of that facility, we’ll move to start that study.
Now, as far as the CDC and USAID are concerned they’re really almost the same thing because USAID relies upon CDC to do it’s technical evaluations, because right now we are not FDA approved in the United States (for the rapid tests) it’s necessary to get onto the USAID waiver list. The waiver list was created because there just aren’t the kinds of products that USAID needs to have available to them that are FDA approved. Even though they are very good products, they had to have a waiver in order to buy, because of the regulations of their agency. So, they have an agreement with the CDC that CDC does the evaluations, shares the results with USAID and if the results meet their specifications then you can be put on the waiver list and they are able to purchase. Again, as soon as we have product out of Thailand we will begin that process immediately and it’s usually not a lengthy process. I think we could probably complete it fairly early. Normally what CDC does is have one of it’s field sights do the evaluations.
Q. Thank you. One quick question, I’ll let others in. On the Incidence test, I forgot to ask, it’s only for HIV 1, does that matter? Does it need to be?
A. It doesn’t matter at all. The pandemic is HIV 1. Ninety nine point nine percent of the infections worldwide are HIV 1. It would be a futile exercise to try to do those kinds of epidemiological studies looking for HIV 2. I can tell you from our past history of an HIV researcher, looking for people who are HIV 2 only infected is almost like looking for a needle in a haystack.
Tom DeHooty with MTV Investment advisers
Q. I just wanted to get a sense… it sounds like your gearing up to do another round of financing. What kind of financial projections your looking at now in terms of when you actually get to volumes of product shipped and revenues?
A. I, Rick you want to take a shot at that? I think you’ve done some numbers and might have a little bit more accurate projection than I do.
A. (Rick) Ya, sure. I think most of next year is going to focus on getting the rapid products off the ground. So, whether or not we start to see some reasonable volumes in 05 out of Africa, I’m not really counting on it. Although, it could happen, we do expect to see obviously an up tick for the Incidence Test. The a, China will come on board sometime, ya know, optimistically in the later part of 05, and so, we’re really, I think, really the volumes for the model we’re working and the financing we’re looking for, take off in 06.
The, a, China will come on board sometime, ya know, optimistically in the later part of 05, and so we’re really, I think really the volumes for the model we’re working and the financing we’re looking for take off in 06.
Q. Why no - few if any sales in Africa, next year?
A. I expect we’ll start to get the sales in the first half of the year. It’s unclear to me at just what levels and volumes. I’ve not, ya know for purposes of a, ya know, cash flow analysis, tried to count on any particular amount out of that.
A. (Dr. George) I think I’m a little bit more optimistic than Rick is, although I’m not at all contradicting what he said. I think the reason we’re looking at another raise of funds is that we are constantly finding ourselves in a position where there are real opportunities for us to build value in the company, and certainly we are going to need additional funds to get to the point where sales of rapid tests and Incidence tests and other things that we are currently manufacturing, are going to be sufficient to sustain us. So, if we took a really conservative approach, we probably would raise much less money than we’re thinking of raising but, I think that would be taking – would actually not be wise, because we really need to have the money to be able to continue to go out and I need to, really need to start filling the pipeline for the Ani platform. I need to either develop tests or I need to acquire tests, through license agreements. I’m not willing to go through the very long drawn out process of making everything from scratch. I want to, to get things in here, get them into manufacturing, make optimal use of all of our facilities, increase our margins and get to profitability as quick as I can.
Q. Well let me ask you explicitly then. When do you think you will get to break even? And in conjunction with that, how much are you talking about raising in this next financing?
A. Again, I’ll turn that question over to Rick.
A. (Rick) Not a hard and fast answer, I mean clearly when the rapid tests are up and running we, our fixed costs are pretty stable and we’ll get to profits fairly quickly so, in a conservative model, without any big rapid sales next year, it would happen in the early part of 06, and I’m going to defer to the Proxy. We’ve got to be a little careful here we don’t have any formal offering in place and it will be a private placement so I’m going to direct people to the Proxy for the guidelines.
Q. Well is the Proxy available?
A. It was filed about an hour ago.
Q. Why can’t you just tell us what’s in the Proxy?
A. Because my attorney suggests that that might impact the ability to do a private offering.
Q. OK
A.(Dr George) And that’s why I turned it over to Rick to answer. I don’t want to say something inappropriately at this point either.
Q. Ok, thank you.
Joseph Johnson private investor
Q. Thank you very much gentlemen for taking my call. My question is, what is the potential market for China and Africa? And the second part of my question is, at one time I thought Magic Johnson was supposed to be coming on as a director for the company?
A. To address your first question about the size of the market in China. You know, the size of that market is really mind boggling. Because, China has such a – they have a significant and a serious problem with the spread of HIV in their population and China has now recognized the seriousness of that threat to their population and have recognized that if it is not addressed very quickly ant appropriately that it could actually begin to affect the economic growth that they have experienced in the last few years. Just to put it a little bit in perspective; sex workers in China; there are approximately 30 million of them that are known registered sex workers. The Chinese government tests those people every quarter. So, if you just do the math; four times 30 million that’s 120 million tests per year, just for that one small segment of the Chinese population. China has recently made the offer to their people, that, they will give a free AIDS test to anyone who requests it. There are 1.3 billion people in China. I don’t mean to suggest that all 1.3 billion people are lined up for an HIV test, but someone who is administering that program in China and at the CDC, he said, about 600 million tests this year in the program and remember people who need testing for HIV don’t test one time. It’s a recurring need because people, being what they are, find out they’re negative and they see that as encouragement to continue to behave in the old ways. I think you get a sense, It’s a huge market. I think we have some good products for that market.
And your second question about Magic Johnson. We had originally – it was our plan to bring Magic Johnson on to the Board of Directors and Mr. Johnson has expressed his willingness to come onto the Board of Directors, but quite honestly, our Board is constituted, due to certain rules. We have to have so many independent directors and so many people who are not independent and the time has not yet presented itself yet when it seems good to bring Magic Johnson on. But it’s still being considered. Rick do you have anything you want to add to that?
A. (Rick) No, I think that’s said very well. It is an ongoing thought, you know, Magic was just with us when we joined the American Stock Exchange and is supporting the Company.
A. (Dr. George) Absolutely, and I have to say, I’ve met Magic now several times and he’s really a remarkable gentleman. So, he’s a wonderful spokesman, he’s a wonderful spokesperson for AIDS prevention and we consider ourselves very fortunate to have him associated with the company.
John Craig private investor
Q. Hello, gentlemen. I was just wondering what is the stockholders meeting December 14th about?
A. (Dr. George) Again, Rick would you like to go over what the agenda will be?
A. (Rick) Sure, the agenda relates to the pending financing that we’re looking at doing, and you know, the details, kind of a list of parameters that the American Stock Exchange has wanted us to delineate. So that’s the sole subject of the special meeting.
Q. Could you say at all, is there any stock reversal possibility?
A. No, that is not one of the proposals, so it is strictly the fund raising.
Final statements from Dr. George
Ok well let me just sort of wrap things up. Again thank you all for joining us today and for asking very excellent questions. Again, I just want to say one more time how excited I am to be a part of this effort. I think we have a great team of people here. We’re making wonderful progress, and I do hope that all of you will continue to remain with us and we believe that in the very near future your going to start to see a return on your investment. So thank you very much.
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