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Chembio Diagnostics, Inc. (NASDAQ:CEMI)

Q1 2007 Earnings Call

May 15, 2007 2:00 pm ET

Executives

Lawrence Siebert - Chairman and President and CEO

Richard Larkin - CFO

Analysts

Stephen Handley - Dutton Associates

Keay Nakae - C.E. Unterberg, Towbin

Presentation

Operator

Greetings ladies and gentleman, and welcome to the Chembio Diagnostics Incorporated First Quarter 2007 Financial Results Conference Call.

At this time, all participants are in a listen-only mode. A brief question-and-answer session will follow the formal presentation. (Operator Instructions).

As a reminder, this conference is being recorded. It is now my pleasure to introduce your host Mr. Lawrence Siebert, Chairman and President. Thank you. Mr. Siebert you may begin.

Lawrence Siebert

Thank you very much. Good afternoon everyone. I am Larry Siebert, Chairman and President of Chembio Diagnostics. It's my pleasure to welcome you all to the May 15, 2007 Chembio Diagnostics conference call. Along with me on the call is our Chief Financial Officer, Richard Larkin.

Before we get into the substance of the call, I would like to first advise everyone that statements made during this call that are not historical facts are forward-looking statements within the meaning of the Securities Act of 1933 as amended.

Those statements include statements regarding the intent, belief or current expectations of Chembio and its management. Such statements reflect management's current views, are based on certain assumptions and involve risks and uncertainties.

Actual results, events or performance may differ materially from such forward-looking statements due to a number of important factors, and we will be dependent upon a variety of factors.

Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstance that occur after the date hereof or to reflect any change in Chembio's expectations with regard to these forward-looking statements or the occurrence of unanticipated event.

Factors that may impact Chembio's success are more fully disclosed in Chembio's most recent public filings with the United States Securities and Exchange Commission, including the annual report on Form 10-K and our first quarter 10-Q financial report.

So, with that again, welcome everyone to our first quarter conference call. Purpose of the call is to discuss our first quarter 2007 financial results, as well as our current outlook for 2007.

I would like to first ask our Chief Financial Officer, Rich Larkin to summarize the financial results for the first quarter. I will then summarize our first quarter activities, including recent developments and we will than be happy to answer your questions. Rich?

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Richard Larkin

Thanks Larry, and welcome everyone. Our revenues included $2.025 million in net products sales for the three months ended March 31, 2007, compared with $1.169 million in net product sales for the three months as March 31, 2006, a 73% increase.

The increase in net product sales was attributable to an increase of $1.273 million in sales of our HIV products, from $538,000 to $1.811 million, a 237% increase, primarily attributable to our sales to our distributor in Mexico.

These increases were partially offset by decreased sales of our Chagas test of $479,000, because the large order that we received in 2006 was not repeated and increases in other product sales aggregating $62,000.

Gross margins on net product sales for the three months ended March 31, 2007 was at 32% as compared to 31% for the three months ended March 31, 2006.

Research and development expenses for the three months ended March 31, 2007 were $319,000, compared with $393,000 for the three months ended March 31, 2006. This category includes cost incurred for regulatory approvals by devaluations and registration.

The details of these increased costs are reported in our 10-Q and include a decrease in the cost to material of $55,000, and a decrease in clinical study costs of $20,000.

Turning to cash availability, the company currently plans to increase its spending on research and development in 2007, because at least such spending will result in the development of new and innovative products that are based on our Dual Path Platform technology.

The company has several R&D projects underway, and Larry will highlight some of these in his remarks.

Selling, general and administrative expenses decreased $45,000 to $1.252 million in the three months ended March 31, 2007 compared with $1.297 million for the same period in 2006.

The details of these decrease in cost are reported in our 10-Q, and including decrease of $99,000 in the cost are classified as investor relations, decrease [link] on carrying expenses of $27,000 and a reduction in marketing consulting of $40,000, offset by increased cost of salaries and wages-related expenses of $52,000 as well as other increased costs.

Our interest income for the three months ended March 31, 2007 increased $52,000 due to the availability of additional funds to invest. In addition, the company received a $133,000 net of expenses from New York State related to a program for qualified emerging technology company.

The company had a working capital surplus of $4.5 million at March 31, 2007, which includes cash of $3.8 million. We believe our resources are sufficient to fund our needs through the end of 2007 and into early 2008, subject to the caveats and assumptions that are set forth in the Form 10-Q report filed last week.

We believe that revenues from our HIV rapid tests will increase significantly in 2007, as a result of the entry in to the United States markets by our U.S. marketing partner, as well as due to the continued growth in our international sales.

The international market for HIV rapid test has become increasingly competitive so that we need to be judicious, and to participate profitably in these markets.

As you may recall, we made a decision in 2005 to establish full-time business development offices in both East and West Africa, i.e. Tanzania and Nigeria, in order to maximize our chances of participating in the scale-up of HIV testing in both East and West Africa.

While we have had some notable successes in this region and anticipate that there will be more, we review this past quarter whether the cost of a full-time business development office in both East and West Africa are still justified. Particularly, since most of the work related to ensuring that we would be eligible [section] in National Testing Articles in that region including WHO and PEPFAR qualification, Our endorsement by the Clinton HIV/AIDS initiative, and the establishment of distribution partners in most countries in that region are now completed.

So based upon our view, we decided to close the office in Tanzania, while keeping Nigeria in place. We will continue to seek to participate in the funded upscale of Rapid HIV testing clients by the United States President Emergency Plan for AIDS Relief or PEPFAR and other donation funded relief programs in the developing world, where we can profitably do so.

That completes the financial summary. Larry?

Lawrence Siebert

Thanks very much Rich. To reiterate, what I said in our last conference call. I believe that 2007 has gotten off to an excellent start based on our first quarter sales growth and based upon what we have in the pipeline.

In addition to significant top line growth, the company achieved other important milestones during the first quarter including, first, was the marketing launch by our U.S. marketing partner, Inverness Medical Innovations of our two FDA approved rapid HIV tests in the United States professional diagnostics market.

We are very pleased with the way this collaboration with Inverness has gone so far, and look forward to working with their capable team, as they and their distributors begin to work for public health, hospitals, physician office, and other markets in United States.

Second, with the issuance to Chembio of United States patent for the Dual Path Immunoassay Device or DPP, our proprietary lateral flow of technology which we believe enables improved features and performance over at least certain conventional single path lateral flow technology.

Progress continues in developing prototypes employing the Dual Path Platform including a new HIV test which can be used with blood or oral fluid samples. Prototypes of several other serological tests have been developed in connection with initial DPP feasibility studies.

And a bit more on DPP, as a result of the successful completion of some preliminary serological studies on DPP during the first quarter and the issuance of our patent, in April we engaged the consulting firms specializing in our industry to assist us during a short-term engagement to identify and prioritize perspective license fees and collaborative partners for our DPP technology.

This process has resulted in our having a list of organizations that meet certain criteria that we jointly develop with the consultants to prioritize our business development efforts, so that we can generate meaningful license and/or product development funding based on this new technology this year.

At the same time, we are making good progress in our efforts to hire senior industry executives to ultimately lead the sales, marketing and business development activities of the company particularly for the DPP technology.

We are doing studies internally and externally, which we hope to complete this quarter that if successful will help to validate additional applications of DPP, well beyond the serology applications that we have done studies for already.

I want to just make sure everyone understands that DPP is not a test; it's a platform technology, on which we believe many tests can and will be developed as a result of collaborations that we hope and expect to enter into with others in 2000 and beyond.

While our focus is on perspective partners in the U.S. and Europe, where we see that there are opportunities to get funding commitments for both R&D and product procurements. We're also looking at product needs in this developing world for DPP, including the area of neglected diseases where simple and accurate rapid tests could play a big part in controlling diseases.

While I can't identify any of the companies that we are having preliminary discussions with under NDA for any of these markets, we did disclose already, well before the pattern of these initiatives that we had a Cooperative Agreement with U.S. Centers for Disease Control to develop a screen and confirm combinations report test. And we are very pleased with the early results from that collaboration based upon the meeting we had with them recently.

Our goal is to complete agreements for the license of our DPP technology together with agreement for Chembio being the development and manufacturing partner with companies that have the ability to access large markets and unmet rapid tests needs.

I should also mention in this connection that we've scheduled our ISO 13485 inspection for this quarter by a notified body, which will enable us to pursue CE marking for our HIV and other products that we choose to market in the EU and another countries requiring this marking. This is also going to aid in our business development efforts.

So overall, with respect to DPP, we are making very good progress on this exciting new technology. Also during the first quarter, we underwent a facility inspection by the USDA, U.S. Department of Agriculture, in connection with the company's first USDA product approval submission for its Non-Human Primate Tuberculosis test, the first in a line of tests for veterinary tuberculosis we have been developing.

Company anticipates receiving USDA approval of this product during this current second quarter of 2007 and for commercialization to occur soon there after, although there is no assurance that this commercialization will be successful.

We signed a distribution agreement for the Non-Human Primate TB test with a specialty distributor Santor who is very familiar with this market and we currently expect to begin to see sales of this product in the U.S. market in this current quarter.

Chembio has completed development and is in the final validation stage on a series of rapid lateral-flow assays for the detection of veterinary TB in additional species. The family name for the technology is VetTB STAT-PAK.

The company anticipates commercialization of these next veterinary TB products to start in second or third Quarter of 2007, although, again, there are no assurances that this commercialization will be successful. And also at the end of the first quarter, we were issued a patent covering the method and use of veterinary TB products across a wide spectrum of animal species.

And with those remarks for which I appreciate your indulgence, Operator, I'm happy to open up the lines to some questions.

Question-and-Answer Session

Operator

Thank you. (Operator Instructions). Our first question is coming from Stephen Handley with Dutton Associates.

Stephen Handley - Dutton Associates

Good afternoon.

Lawrence Siebert

Hi, Steve how are you?

Stephen Handley - Dutton Associates

Fine, thanks.

Lawrence Siebert

Good.

Stephen Handley - Dutton Associates

It sums out how I couldn't be happier.

Lawrence Siebert

Yeah. Thank you.

Stephen Handley - Dutton Associates

A couple of things, last week I guess you announced this Letter of Intent with Avago Technologies.

Lawrence Siebert

Right.

Stephen Handley - Dutton Associates

And I wonder if you might just collaborate on that in terms of the opto-electronic measurement technology that they have. And what's sort of the timetable for developing rapid POC diagnostic based on the integration of their technology with your DPP technology?

Lawrence Siebert

Yeah. Avago as you may or may not know their rapid diagnostics division is a large former division of Agilent, which actually initially came out of Hewlett-Packard. And a lot of the technologies that are in this rapid diagnostic instrument division come out of some of the technologies originally developed within Agilent having to do with some of these optical, scanning and digital imaging technologies.

What we've seen Steve, is that, particularly if we are going to get into the area of antigen detection whether it would food testing or food safety, environmental testing that you've got to be able to quantitate the results, you've got to be able to record and transmit the result. And you need to take as much subjectivity out of all that as possible.

And one of advantages that we've seen with DPP even in the serological antibody detection studies is that the clearance of the membrane which when you don't have clearance you get kind of noise signal in your reading instruments whoever instrument it is. But the background, ghost-lines and other noises are significantly reduced.

So, as we've been going out speaking to a number of companies that are interested in developing new rapid tests in the antibodies as well as antigen detection. They clearly express the need to have a reader. In this particular technology that Avago brings, is particularly useful because it can be brought down to a size that is almost disposable, that could be disposable with certain tip sizes.

And so, we are as part of our business development efforts with companies interested in developing products with DPP. We are bringing that solution along with us and offering that possibility. So, I don't have a specific time table for any particular product, until we announce specific collaboration with companies desiring that technology.

We have done some studies with their reader, with certain of our prototypes showing the quality of their technology and how DPP enables their technology to work even better. But that is as far as we gone with it at this point, and I can't really give you anymore of the time table.

Stephen Handley - Dutton Associates

Okay. Let me ask you. What can you say about the roll-out that Inverness has on your HIV tests to the extent to which they have access their various accounts, and sort of related question would be, so your best guess on when you or they or you would get a clear waiver for the SURE CHECK conversion?

Lawrence Siebert

Sure. SURE CHECK's now been marketed by Inverness under the complete HIV 1/2 brand name formerly called SURE CHECK, right?

Stephen Handley - Dutton Associates

You're right.

Lawrence Siebert

Right, okay. They clearly are committed to this product line. I guess the short answer is, I can't tell you a lot. I don't want to compromise their fine efforts in accessing and creating and expanding this market for our products and their products.

We have disclosed in our 10-Q the geographic breakdown of our sales. And we do it by continent I believe. And we have North America, which includes Canada and Mexico. And as we have disclosed in the past we have significant business in Mexico still under the SURE CHECK label because that market was carved out in our agreement with Inverness for at least the first year.

So that number doesn't tell you what we sold just in the United States, but it does show you what we've sold in the U.S., Canada and Mexico. I just think it would be a dis-service to Inverness's efforts to breakout those numbers at least at this point.

I think, as we go forward from quarter-to-quarter, if we're seeing revenue growth accompanied by improved growth margins than that of the indication that Inverness is being successful. We had modest improvement in our growth margins in the first quarter of this year as compared with last year. I don't know if there's enough of a difference for you to make any conclusions from it. But I want to very careful and respectful of Inverness's efforts at this point.

Stephen Handley - Dutton Associates

Okay. I likely didn't expect to hear a qualitative statement on the sales that they have done. But I just wanted sort of the status of if they started selling in may be February or March or --

Lawrence Siebert

They placed these first orders with us early in the quarter, since they would be able to launch the product when they did in this quarter. And I think that all the signs are very good. I mean they have great distribution network in all of the markets that are important for these kinds of products.

They are adding more resources to that network. They are engaged, I believe, at the state and local as well as federal level. They clearly are doing things in terms of motivating their sales force to be successful. And there is clear evidence of their advertising campaign if you look in the trade journal such as some of the physician's office market place journals and the clinical laboratory journals.

You will expect that with some of the events surrounding our National HIV Testing Day that there may be some promotional activity that they may be attempting, I don't know it specifically. But so far the qualitative read I have is a very high level of commitment and effort.

Stephen Handley - Dutton Associates

Just a last follow-up on that. Would it be logical to expect that your sales to Inverness will be higher in the second quarter versus the first quarter or should the fact that there maybe inventory advances there reduction not necessarily or let's just say perhaps that prohibit that sequential gain or is it too early to tell?

Lawrence Siebert

Yeah, I think that we've gotten a forecast from them that allows us to enable them to not have to sit to keep inventory in warehouses. And we'll see what happens during this quarter. But we are optimistic that over the long term, if the sales are going to grow, I don't want to specifically answer your question, but in terms of what the volume in Q2 versus Q1 is going to be. But we are seeing good progress with our effort and we continue to respond to their orders in a timely fashion.

Stephen Handley - Dutton Associates

Okay, thank you very much.

Lawrence Siebert

Pleasure.

Operator

Our next question is coming from Keay Nakae with C.E. Unterberg, Towbin.

Keay Nakae - C.E. Unterberg, Towbin

Hey Larry.

Lawrence Siebert

Hey Keay, how are you?

Keay Nakae - C.E. Unterberg, Towbin

Good. I might have missed this, but with respect to the USDA inspection of your facility, is there anything that needs to be done to close that out? Or what's the final gating item before your launch the product?

Lawrence Siebert

I think is that at this point its mechanics, its sign off at the USDA. There's nothing that I am aware of that other than really just mechanics to get the license certificate in the mail.

Keay Nakae - C.E. Unterberg, Towbin

Okay. And once you have that, are you at this point building inventory or what's your situation in terms of launching a product?

Lawrence Siebert

Well until we get the approval -- with the USDA approved products a little different than with FDA where they actually have to approve each lot that we manufacture. So, the time to manufacture a lot is measured and to have it through final assembly into finished product is to be measured in a few weeks not months. So that once we get the sign off we will than be able to manufacture a lot that we can than send to them for approval, so that than we can supply our distributor with a USDA approved lots of product.

Keay Nakae - C.E. Unterberg, Towbin

Okay. And as far as your training of them in terms of how to do the testing of those individual lots, that's all locked out at this point?

Lawrence Siebert

That's been done, yes.

Keay Nakae - C.E. Unterberg, Towbin

Okay, very good. With respect to the HIV product sales in Mexico, in the filings it did state you've had at least a little bit of a follow-on order. What is your expectation of what that might look like in the second half of the year?

Lawrence Siebert

They have done a good job of penetrating this particular market in the federal government program in Mexico. But, like many of the other markets that we participate in, it's lumpy. And I believe that their goal is to have 2007 overall at least equal to 2006. And I have asked them for a forecast, I don't have it yet for the second half of the year.

We may see some additional of business this quarter. But, my impression in speaking with our distributor and the other group that they are working with in Mexico, who I have spoken with is that, this is not one-time order that is should repeat.

But, until I get a better handle as to what the second half of the year is going to look like, I don't think I could really tell you with any kind of certainty.

Keay Nakae - C.E. Unterberg, Towbin

Okay. And then with respect to the license you have with Inverness how it affects the….

Lawrence Siebert

The lights that I have with Inverness or [license]?

Keay Nakae - C.E. Unterberg, Towbin

The license you have and how it affects sales going forward once that carve out from Mexico expires? The way we should look at that is that you then will be paying a royalty once it expires for any sales through their distributor in Mexico post the fall of '07?

Lawrence Siebert

Well right now for this year Inverness is not selling in Mexico…

Keay Nakae - C.E. Unterberg, Towbin

Right. Understood.

Lawrence Siebert

Okay. And for these sales that we're making to our distributor in Mexico during this year, we are paying a license or a royalty to Inverness on those sales. If this arrangement is not extended, then we would be selling to Inverness in accordance with our agreement in the U.S. I mean the same agreements. The royalty would be a transfer price that we would be selling to Inverness based upon our margin sharing formula.

Keay Nakae - C.E. Unterberg, Towbin

I guess, what I am trying to get a handle on is as far as follow-on sales in subsequent years is that going to be a situation where Inverness is now going to have to go to the entity in Mexico and facilitate that?

Lawrence Siebert

Yeah well that is one thing that will have to happen if they are going to take over in Mexico. They will need to have the product registered under their name with the Ministry of Health or the other related entities that require the registration to be transferred.

So that is a process that we'll need to begin soon in order for it to happen. I don't think it's [considering] that in any case, it's getting a royalty as I just described to you in the current situation. I don't think it will be in their interest for there to be any gap in sales, whoever is booking the revenue because they will be giving up the royalty.

So, I think that we'll have continuing sales. If the business, the underlying demand in Mexico for this product continues, there won't be a gap in the revenues. It's just a question of whether we are selling it through Inverness or directly through the distributor in Mexico.

Keay Nakae - C.E. Unterberg, Towbin

Okay.

Lawrence Siebert

Does that answer your question?

Keay Nakae - C.E. Unterberg, Towbin

It does, yes. With respect to -- I think the previous caller asked this question, I am not sure we got the answers as far as the timing for clear waiver for SURE CHECK?

Lawrence Siebert

I am sorry. Thanks for reminding me. Sorry about that please. We are now waiting for some devices that would be part of the packaging with the test that would replace the rack that's currently used with the test or as an alternative to the rack. And once we get those final devices they're like [hoggers]. We would then do some mock trials here, that would then be followed on, and if successful would be official clear waiver trials over the next few months or a couple of months with the hope and expectation that some time late in the summer, we would be able to complete everything needed for a clear waiver and get the clear waiver by the end of the third quarter.

Keay Nakae - C.E. Unterberg, Towbin

Okay. With respect to the initial Inverness launch of your HIV products in the U.S. What do they have in their marketing campaign related to the new CDC guidelines?

Certainly that's a significant change in the guidelines, yet at the same time there are some other logistical barriers with certain [payors] program. So what are they doing on their end to push the awareness of the new guidelines and try to facilitate a seamless transition to adopting those?

Lawrence Siebert

Well I think that they're involved in a number of efforts on a state-by-state basis to understand where that particular stage is in the process of adopting these CDC regulations as recommendations, I should say.

I think, as you know, the CDC recommendations are just that, they are recommendation. And so each state needs to go through a process of figuring out what aspect or aspects of those recommendations will be enacted into new HIV testing procedures in that state.

And it's my understanding that there is progress being made, that's being promoted not just by Inverness but by all the companies that stand to benefit from this in many of the major states where HIV testing represents a significant number. And those states are obviously New York, and Florida, and Illinois, Texas, California and some of the other mid-West states as well.

And, still I believe that, for example, last week or the week before there was a change enacted in the State of Illinois since in public record, where the CDC recommendation, testing recommendations were modified to incorporate at least certain important aspects of these new CDC guidelines that will encourage more testing to take place.

Keay Nakae - C.E. Unterberg, Towbin

Okay. Switching gears over to the DPP and follow-up question with respect to the announcement with Avago. As you moved towards providing a more quantitative test, what kind of price point for this reader are you guys thinking about?

Lawrence Siebert

Well I think the reader can be priced in the hundreds of dollars possibly less than that, depending upon the complexity of the instruments and the quantity of the demand. But they have manufacturing capability in Asia for these instruments, that's where they are manufactured. They have a very sophisticated engineering capability where different features can be incorporated and standard instruments could be modified fairly easily based upon their technology.

So I think that there is some reason to believe that these instruments can be manufactured for if not one-time use may be one-kit use. And if that's going to be the case, you have to be looking at an instrument that would be under $100. So whether that's going to be cost justified for a particular product is something that we are going to have to look at with the particular partner that we are developing the products with.

Keay Nakae - C.E. Unterberg, Towbin

Okay. So it sounds like you are moving more towards that model where the lack of a better description and that the pain threshold of moving from a qualitative test to a quantitative test and the need for that instrument is minimized by perhaps having it be a single-use throw away type of instrument?

Lawrence Siebert

Yeah that's a step to keep the possibility that this technology that Avago offers. Whether we can get there based upon certain products, I don't now yet.

Keay Nakae - C.E. Unterberg, Towbin

Okay. And then with respect to your own developments of the oral fluid test on DPP, at this point are you waiting for a partner to come in and just fund the more intensive clinical data that needs to be done to commercialize a product on that platform?

Lawrence Siebert

Yeah. What we have, as you know, developed a oral fluid HIV application on the DPP platform or it can be used with oral fluid or blood, and oral fluid or blood makes the serum plasma thing which can be in this whole blood. And we have identified several prospective partners, can't really comment as to where we are in those discussions. But, we are not planning on funding that product ourselves.

Keay Nakae - C.E. Unterberg, Towbin

Okay, very good. Thanks a lot.

Lawrence Siebert

Okay. Thank you.

Operator

(Operator Instructions). Gentlemen, it appears there are no further questions at this time. I'd now like to turn the floor back over to management for any closing comments.

Lawrence Siebert

Okay. Thank you all for participating in the call, and we look forward to keeping you apprised of our progress, and we'll look forward to our second quarter conference call in the middle of the summer. Thank you very much.

Operator

Ladies and gentlemen, this does conclude today's teleconference. We thank you for your participation and you may disconnect your lines at this time.

TRANSCRIPT SPONSOR

Dutton Associates is one of the largest issuer-paid equity research firms in the United States, and our investment performance is ranked comparable to that of the top Wall Street firms. Our analysts, primarily CFAs with over 20 years of experience at the major securities firms, are among the most experienced on Wall Street. We offer high-quality, independent, fundamental research on small-cap public companies in a year-long program consisting of an initial report, three quarterly update reports, research notes between the quarters, and institutional conferences and roadshow opportunities.

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