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Chembio Diagnostics Inc (NASDAQ:CEMI)

Q1 2014 Earnings Conference Call

May 8, 2014 10:00 AM ET

Executives

John Sperzel - CEO

Rich Larkin - CFO

Analysts

Raymond Myers - Alere Financial Partners

Joe Munda - Sidoti & Company

Jan Wald - Benchmark Company

Paul Nouri - Noble Equity Funds

Brian Marckx - Zacks Investment Research

Larry Haimovitch - HMTC

Operator

Greetings, and welcome to the Chembio Diagnostics First Quarter 2014 Financial Results Conference Call. At this time all participants are in a listen-only mode. A question and answer session will follow the following presentation. (Operator Instructions) As a reminder, this conference is being recorded. I would now like to turn the conference over to Mr. John Sperzel, CEO of Chembio. Thank you, Mr. Sperzel, you may begin.

John Sperzel

Good morning. Thank you all for participating in today’s call. Joining me today is Rich Larkin, our Chief Financial Officer.

Before we begin, I'd like to caution that comments made during the conference call today, May 8, 2014 will contain forward-looking statements within the meaning of the Securities Act of 1933, concerning the current belief of the company which involve a number of assumptions, risks and uncertainties. Actual results could differ from these statements and the Company undertakes no obligation to revise or update any statement made today. I encourage you to review all the Company’s filings with the Securities and Exchange Commission concerning these and other matters.

I spent nearly two months since joining Chembio as CEO, and my optimism continues to grow. The company is poised to make a number of pivotal advances in the near term and given my experience in the diagnostics market, specifically the point-of-care diagnostics market, I recognize the opportunities ahead. Our product portfolio is well accepted by customers around the world. Our management team is experienced and dedicated and our Chembio brand of DPP products is being readied for launch in the United States.

2014 will be a transformational year in Chembio’s history and I’m happy to have this opportunity to share our results, goals and strategies for growth. I’ll provide an overview of our recent and anticipated milestones, following the review of the first quarter financial results and balance sheet by Rich

Rich Larkin

Thanks John, I will briefly go over the first quarter 2014 results with comparisons to the first quarter of 2013. And please review our 10-Q filings for more details. We had total revenues for the quarter of $5.81 million, a 13% decrease compared with total revenues of $6.68 million in 2013. We had product sales of $4.9 million, a 22% decrease compared with product sales of $6.31 million in 2013. Our research and development milestone, grant and royalty revenues for 2014 were $0.91 million, a 149% increase as compared to $0.37 million in 2013.

Gross margin for the 2014 quarter decreased 16% to $2.27 million, compared with $2.69 million for the prior-year period. This was primarily due to the decrease in product sold. The product gross margin for 2014 decreased 41% to $1.36 million, from $2.33 million in the prior-year period. Our research and development expenses in 2014 were $1.2 million, compared with $1.05 million in the prior-year period. Selling, general and administrative expenses in 2014 increased 25% to $1.46 million from $1.16 million in the prior-year, largely due to increased investment in sales and marketing personnel and related costs.

Our operational loss for 2014 was $383,000, compared with an operating income of $487,000 for the prior-year period. Net loss for the 2014 quarter was $225,000, or $0.02 per diluted share, compared with net income of $317,000, or $0.04 per diluted share for the prior-year period. We had cash-and-cash equivalents of $9.09 million as of March 31, 2014, compared with $9.65 million as of December 31, 2013. The primary reason for this decrease was due to net cash used in operating activities in the first quarter of 2014. Our working capital decreased by 309,000 during the year from $14.22 million to $13.91 million.

I'd like to thank you for your time, and now I will turn the call back over to John.

John Sperzel

Thanks Rich. During the first quarter we were disappointed that our financial results were below expectations. We believe a good portion of the first quarter variance is due to the variability in purchasing levels, which has been the nature of Chembio sales in international territories that depend on significant government funding. A critical part of our growth strategy is to build the commercial organization and establish the Chembio brand for our DPP products, particularly in the United States. This is my area of expertise, and the opportunity to create this capability for Chembio is one of the reasons I joined the Company.

Our U.S. commercialization efforts will involve our proprietary DPP platform products, including our DPP HIV assay and eventually our DPP HIV syphilis assay. Our lead product, the DPP HIV Oral Fluid assay is one of the most functional HIV assays available. The assay is easy to use, rapid and exceptionally sensitive. It detects antibodies in oral fluid or blood, and its unique SampleTainer makes it particularly well-suited for point-of-care testing in the field. Chembio received FDA approval for this product in December 2012, and we expect to initiate our marketing efforts in moderately complex sites in 2014. Once a CLIA Waiver for this product is granted and we do believe it will be granted. I’ll provide more information on that in a moment. We will expand our commercialization effort to the broader professional testing market.

Once we gain appropriate regulatory approval, we plan to commercialize a DPP HIV syphilis assay. We believe there are significant risk related to transmission of syphilis from a pregnant mother to a child, just as there are for transmission of HIV. And we believe there is a significant opportunity to reduce mother to child transmission globally. On April 7 we announced the termination of the U.S. STAT-PAK distribution agreement with Alere. And I wish to refer you to our press release of that date with respect to any questions you may have concerning this matter.

Finally, I would like to provide an update on our regulatory progress. As we reported at year-end, the FDA requested additional clinical data prior to ruling our CLIA Wavier application for the DPP HIV assay. We're pleased to report that we made significant progress on this topic. As a result of recent discussions the FDA agreed to complete the review of the CLIA Wavier application based upon data from additional internal studies, which will be conducted at Chembio.

Though we previously reported the delay in the U.S. product launch, as a result of the FDA’s original position, we now believe this more recent development will accelerate our time to market for the DPP HIV assay, which we now expect in late 2014, although of course there can be no assurances. The Chembio regulatory team is talented and I'm confident in their ability to obtain appropriate regulatory approvals for our products, including FDA approval and CLIA Wavier.

We believe that a combo DPP HIV syphilis product will also achieve regulatory success. This regulatory competency is critical as it represents a significant step toward building our product portfolio and introducing Chembio branded DPP products to customers on a global basis. In closing, I'd like to say that I’m very happy to be leading the Chembio team, while we have a lot to accomplish the opportunity for growth in the U.S. and abroad a significant. In the coming months our focus will be on the following.

Establishing Chembio’s brand and commercial team for our DPP products in the United States, seeking regulatory approvals for DPP HIV, and subsequently DPP HIV syphilis assays, prioritizing product development investments, and expanding international sales. We look forward to reporting our progress with these initiatives in the next quarter. Thank you for your participation and support.

I'll now turn it back to the operator for Q&A.

Question-and-Answer Session

Operator

(Operator Instructions) Our first question is from Raymond Myers of Alere Financial Partners. Please go ahead.

Raymond Myers - Alere Financial Partners

Thanks for taking the questions, and just to be -- to clarify Alere Financial has no relation to Chembio’s former sales and marketing partner by the same name. John, I thank you for hosting the call. And my first question is related to your sales and marketing expansion, you've spent a little bit of extra investment recently on those areas, and I’m curious what exactly those investments are and how you expect them to improve performance going forward? Thank you.

John Sperzel

Sure. All right, thank you very much. We have already hired a Director of Sales for the U.S., we have hired a senior Director of Sales and Marketing that is principally focused on the U.S., but also has global responsibility. We have hired our first sales rep. We are continuing to interview additional sales representatives. I can tell you that I have personally been involved in the interview process. I’m very pleased with the quality and experience of the folks that we are interviewing and hiring. We are also building our customer support capabilities that is for inventory and front-line technical support and I'm very pleased with the progress on those fronts is on track as well. Of course, Ray, we expect that those investments in the U.S. commercial organization will in effect put our hands on the steering wheel and enable as to have stronger growth in the United States market.

Raymond Myers - Alere Financial Partners

That sounds great, thank you. Could you give me a little more detail into the DPP HIV syphilis regulatory counseling?

John Sperzel

Sure, as I mentioned in the prepared remarks, we have had recent dialogue with the FDA, specifically related to the performance of our DPP HIV assay in the clinical trials. And I have to say we applaud the FDA for its data driven approach during these discussions and we’re frankly grateful that the FDA is taking a scientifically accurate position in the latest assessment, and as you see the results of that are quite positive. We expect to -- again although there are no assurances, have a CLIA Wavier within 2014.

Raymond Myers - Alere Financial Partners

So that’s the CLIA Waiver for the DPP HIV, so congratulations for making progress there. How about the one that also includes the syphilis assay?

John Sperzel

So we still have progress to achieve on the DPP HIV syphilis assay. As you can imagine we are prioritizing our efforts internally and our focus has been on the DPP HIV assay. Once we get that, we'll then turn our efforts to the DPP HIV syphilis assay.

Raymond Myers - Alere Financial Partners

Great, sounds reasonable, thank you. I’ll get back in queue.

Operator

Thank you. The next question comes from Joe Munda of Sidoti & Company. Please go ahead.

Joe Munda – Sidoti & Company

Good morning John and Rich. Can you hear me okay?

John Sperzel

Hi Joe, we sure can.

Joe Munda – Sidoti & Company

John, I know in your prepared remarks you spoke of reference to press release with Alere way back when -- but I was wondering is there any way you can give us some color on what STAT-PAK sales were in the quarter? The percentage of the revenue, that would be great.

John Sperzel

So, I understand your interest in that Joe, what I would like to do is come back to you with additional commentary on the U.S. market with respect to product sales in the next update.

Joe Munda – Sidoti & Company

Okay, understood. And then as far as Ray touched on the SG&A line there -- as far as R&D going forward, is this a normalized level we can model out quarterly here at 1.2 million? Or are we expecting an uptick in regards to HIV syphilis?

John Sperzel

That’s a great question. If you look at our investments in product development or R&D in 2013, it was at about the 20% of revenue level, which as you know is quite high for diagnostic company, the smaller ones tend to invest as a higher percentage just because of the numbers. But what I can say is -- in my first two months I have taken a deep dive into all aspects of the company including R&D, in an effort to get a clear vision and strategy and to establish organizational priorities. And so just to give a few examples on the commercial side, that led to the final decision which we announced on April 7 to terminate the STAT-PAK distribution agreement with Alere, and really takes specific actions to build the U.S. sales and marketing team to promote initially our DPP products.

On the regulatory size for example, that led to our recent developments with the FDA and our progress on the DPP HIV CLIA Waiver status, which we are certainly optimistic about as I previously mentioned. On the manufacturing side, for example, it led to a number of changes in our headcount which now stands at about 186 full-time equivalents. It led to changes in structure which we believe are going to be positive and will lead to continued investment in facilities and manufacturing automation which have been discussed on prior calls.

The answer to the question about product development, this is an important investment for Chembio as it has an impact on our current spending and on our future product portfolio. So we are going to take a little more time to reassess the market potential for certain products, like our fourth generation HIV test, like point-of-care HCV test, which if any of you listen to one earnings call yesterday, it continues to show growth. In the meanwhile, as I said earlier, we are going to continue to focus on DPP technology which we believe has significant opportunity for commercial success and for technology partnerships, and achieving the CLIA Waiver for our first DPP HIV test will not only help us commercially but it will help us in terms of potential partnerships.

And then lastly, we'll also seek targeted research brands. We have a history of obtaining research brands. We certainly want to make sure that they are aligned with our business strategy, and that they have the potential for real business value. So I have taken the first deep dive, we still have more work to do in terms of our product development or our R&D priorities, and I look forward to sharing more on that front in future calls.

Joe Munda – Sidoti & Company

Okay, that was great. And then, I guess my final question, and then I'll hop back in the queue here. The drop off year-over-year in South America revenues -- any color you could provide there with what’s going on with FIOCRUZ and Labtest would be very helpful.

John Sperzel

Sure, I mentioned, the terms that have been used in the past of lumpiness or inconsistent ordering patterns and we see that, and others see that, we're selling with largely government funded territories or countries. And so we believe that accounts for a large percentage of the variance in the first quarter. Latin America, specifically, we're very active in Latin America. In our corporate presentation, we stated about 50% of our revenues come from the region. As you know, that businesses heavily driven by government tenders, so for competitive reasons, I would rather not discuss by country specifics. I will say that we continue to pursue what we might consider traditional sales, which are through local distributors in the region, as well as more sophisticated partnerships that involve technology transfer which provide an opportunity to establish local low-cost manufacturing such as our partnerships in Brazil. So we continue to be very active in the region and we expect growth in the region, and however we did see some of the inconsistent ordering patterns during that first quarter.

Operator

Thank you. The next question is from Jan Wald of Benchmark Company. Please go ahead.

Jan Wald - Benchmark Company

Good morning, and I guess welcome aboard.

John Sperzel

Thank you, Jan.

Jan Wald - Benchmark Company

I have a couple of questions. I guess one is just on the CLIA Waiver review. It sounds like that you have to do some more work on the test -- on the study. Is that something that's ongoing and completed? Or is that something you need to do now in order to go back to the FDA?

John Sperzel

We need to do that now. The timeline on that, I would call quite short.

Jan Wald - Benchmark Company

So it’s not a large study and not a large follow-up or any those kinds of things?

John Sperzel

That’s correct.

Jan Wald - Benchmark Company

Any sense of what -- can you give us any kind of sense of what kind of study it is? Or what they’re asking for?

John Sperzel

Jan, we’re clarifying with the FDA at the moment before we jump into it. So, I would certainly be able to update you on that in the future. Hoping at least positive news than what the study looks like.

Jan Wald - Benchmark Company

Okay. And I guess, one question I have is, going direct in the U.S., what does that do for you? Does that somehow get rid of some of the lumpiness that we are seeing now? How does that help you? And if it works in the U.S., are going to take that direct idea internationally?

John Sperzel

Sure, that’s a great question. I think it’s a matter of, first talking about the lumpiness. I think it’s fair to say that the lumpiness tends to be more of an international phenomenon than a U.S. phenomenon, just given the nature of the business. So I would just say that first. In terms of building our own commercial organization, we have been a Company that's relied predominantly on partners. And we will be at our best when we have partners whose interests are completely aligned with ours. And in the case of the United States market, we believe that the best strategy for Chembio at this stage is that of our own sales and marketing organizations and so that’s what we have decided to do. The Company has been evaluating that opportunity for a number of months, and we made that decision and it started with the announcement of the STAT-PAK termination in April.

Jan Wald - Benchmark Company

Okay, and I guess, just one thing on the lumpiness in the reorder rate. What assurances do you have in, I guess in thinking that it is a lump that's actually -- there's two parts to lump, you go down and then you come back up. What kind of assurance do you have that it's going to come back up? Do you have a backlog? Are you seeing more interest? Why gives you a belief that things will straighten out in the long run, right now rather than seeing a general trend, [indiscernible] trend?

John Sperzel

Well, every day we become less and less reliant on a particular country or a particular partner within our country, and so to use the analogy of getting more shots on goal, every day we get more shots on goal, and so that gives me confidence that we are likely to win more opportunities. Because our products are meeting the needs of our customers globally and so to the extent we can increase the shots on goal, we believe that we will increase our performance.

Jan Wald - Benchmark Company

Okay, and right now do you have some kind of confidence that the backlog is building, so that this lump goes away and next quarter looks better for you or what or not?

John Sperzel

Sure. I wouldn’t give guidance on next quarter, but I would say that we are confident that the shots on goal are going to produce results.

Jan Wald - Benchmark Company

Okay and I guess just my final question is, in terms of modeling for the rest of the year, how should we think about R&D spend, SG&A spend, and then I guess revenues in terms of lumpiness? I recognize you may not want to give guidance, but just directionally where do you think things are going to be going?

John Sperzel

So, I’m going to ask Rich to help on that one Jan.

Rich Larkin

Jan, again as you know we don’t give guidance. And as you know certainly there is that lumpiness. Our spend on R&D, I believe we can comfortably say, will continue. Because again, that’s a very important aspect to building our business. And we certainly want to take advantage of the great team that we have here. The first quarter on the SG&A, usually it tends to be a little bit heavier because one of the expenses that we have is certainly the audit fee, they catch expense in the first quarter. But I can’t really say too much more beyond that.

Jan Wald - Benchmark Company

Okay, thank you very much.

John Sperzel

Thank you, Jan.

Operator

The next question is from Paul Nouri of Noble Equity Funds; please go ahead.

Paul Nouri – Noble Equity Funds

Good morning. Looking at the Alere agreement and the STAT-PAK sales, can you talk about your ability to maintain any of those sales after the agreement? Like, do you have any kind of relationship with the customers that Alere had?

John Sperzel

So, today I can’t get into a lot of the details about the relationship with Alere. They continue to be our exclusive partner at the moment. I think it’s fair to say that they were the ones who had the relationships with the customer. It was designed that way. Unfortunately, calling on the public health sites, which is what we initially intend to do for our DPP products, out of the gate. It’s a finite number. We know where they are and we believe and we're confident that we can reach those customers ourselves and what I would call more classical distribution partner or partners, and via telemarketing and outbound efforts we can identify in advance solid leads and understand what those customers are using as well. Getting our arms around that and getting stronger every day.

Paul Nouri – Noble Equity Funds

And then, on the international front with RVR and Labtest -- are those two kind of still slated to go online in 2015?

John Sperzel

Yes, they are. In fact, I don’t how much has been shared about RVR. So perhaps, I’ll make just a few comments. We're aggressively pursuing opportunities to commercialise our products in Latin America which I talked about a little bit and in Asia, which are both high-growth regions. Our partnership with RVR is our first in Asia. And while they are less recognized than some distributors, we believe our relationship with RVR represents a pretty significant opportunity for Chembio -- for a few reasons. One, they'll manufacture our products in Malaysia and we'll receive royalties on sales. We believe that their manufacturing capability is key because it will allow us to compete more effectively against lower price point products in Asia.

RVR is dedicated to being a high quality producer, which is very important for Chembio, that’s part of our value proposition to our customers with high quality products, with a goal of being an FDA approved manufacturing site. RVR has the backing of leading universities and government agencies. We believe this will give them credibility as they build our outreach throughout Asia, and they’re connected to leading hospitals, which is important in terms of expediting access to patients and accelerating clinical trials. So, while they are not well-known, they are highly motivated, their interests are aligned with ours and we are confident about that partnership. I personally met with the people at RVR, and I can tell you that we share the enthusiasm and excitement.

Paul Nouri – Noble Equity Funds

So I guess, then additional manufacturing at RVR, they’re going to be selling on your behalf also?

Rich Larkin

Well, that’s certainly one of the possibilities. But the initial contract for them is to manufacture and sell.

Paul Nouri – Noble Equity Funds

And is it for all of your products, or DPP specifically?

Rich Larkin

Currently that agreement is for the DPP products.

Paul Nouri – Noble Equity Funds

Okay, thank you.

John Sperzel

Thank you.

Operator

(Operator Instructions) And the next question is from Brian Marckx with Zacks Investment Research, please go ahead.

Brian Marckx – Zacks Investment Research

Relative to the termination agreement with Alere, does that relate only to STAT-PAK or does that relate to CLIA Waiver complete as well?

John Sperzel

It relates only to STAT-PAK.

Brian Marckx – Zacks Investment Research

And in terms of selling direct, is there any kind of early legwork that you can do prior to the June 3 exploration? Kind of in terms of reaching out to their accounts or other accounts, kind of a introductory type meeting?

John Sperzel

So, I won't comment on their timing and anything related to the STAT-PAK agreement or the partnership with Alere. But I will say is we have all rights to go out and market and sell the DPP HIV test, albeit in a moderately complex environment today. And we are taking all measures to do that. So that’s our focus today. Of course, the subsequent focus is their DPP HIV CLIA Waiver, and we will continue to build the business from there.

Brian Marckx – Zacks Investment Research

As far as Alere's account to go, is that -- based on your experience, is it reasonable to expect that their accounts would reach out to you as well, so it would be kind of a two-way street as far as detailing?

John Sperzel

It would be premature to say that. I’m sure we will be able to share more about the U.S. commercial efforts in our future call and I really look forward to doing that.

Brian Marckx – Zacks Investment Research

How about the kind of transition? Is it your expectation that there would be sort of seamless transition in terms of what we see with revenue or is it an expectation that there may be kind of a significant hiccup, I guess?

John Sperzel

That’s another point that I'm going to have to comment on in a future call.

Brian Marckx – Zacks Investment Research

How about size of your sales force expectations towards, say the end of the year?

John Sperzel

That’s a great question. So we are going to start out with a small team because we are going to be calling on public health sites only in the initial phase, and as quickly as we can accomplish things like getting the DPP HIV CLIA Waiver, or expanding our portfolio both through organic measures or through in organic measures, we will build the sales team appropriately. It's probably best described as a scenario that pace for itself, and I’m a big proponent of that. So I’ll be happy to go to the Board and as for more sales resources as they are warranted.

Brian Marckx – Zacks Investment Research

Do you have any insight into the number of accounts that Alere had for your products? And say the number of kind of major accounts?

John Sperzel

Not at this time.

Brian Marckx – Zacks Investment Research

Last question is on DPP sales to FIOCRUZ. On a previous call, Larry had mentioned that he expected the level of sales in 2014 to be similar to that in 2013. Is that still the expectation?

John Sperzel

That is still the expectation.

Brian Marckx – Zacks Investment Research

All right. That’s all I had. Thanks a lot.

John Sperzel

Great, thank you.

Operator

Thank you. The next question is from Larry Haimovitch of HMTC, please go ahead.

Larry Haimovitch – HMTC

Good morning John.

John Sperzel

Hi Larry, how are you this morning?

Larry Haimovitch – HMTC

Great, how are you?

John Sperzel

Excellent.

Larry Haimovitch – HMTC

Two questions, one I guess, you’re been on-board now a little over a month. I’m wondering what has been the most pleasant surprise for you as you had a chance of totally assess the company and its assets?

John Sperzel

Actually Larry, it’s almost 2 months, but it’s going so quickly, it does feel a bit like a month. The most pleasant things are the amount of support that I received both from the leadership team and from the Board. Very welcoming.

Larry Haimovitch – HMTC

And then, the balance sheet. You burned some cash obviously in Q1. You don’t want to continue burning -- it was 800,000 in cash or something like that in this quarter. What are your thoughts about staunching the cash burn and more importantly whether you foresee [indiscernible] raise more capital at some point?

John Sperzel

I don’t pursue the need to raise capital at this point in time. We believe that we have sufficient cash to make the investments that we have planned in 2014, and on there. Rich, would you like to make any additional comments?

Rich Larkin

Most significant reason for, obviously the cash burn was the loss that we sustained. But, again the expectations -- for the lumpiness, again should be improving as we go on. And so we would necessarily expect that to continue.

Larry Haimovitch – HMTC

True, but you've got to make up the loss sales for STAT-PAK, and in the very short term that might be difficult, I realize of course you're bringing some your own sales reps on, but it’s possible that you could experience another quarter or maybe two of sales being on as good as you hope, and cash balance does concern me. Rich you're probably the one most concerned about, since you’re the CFO. Do you have a comfort level below which you wouldn’t want to go, like 5 million, kind of the number at which you start getting very nervous?

Rich Larkin

I don’t have any specific number in mind. I believe that you’re correct in saying that while we are -- as in any type of business when you start to invest, it does cost you money, but in the long run the hopeless for a larger [indiscernible] And at this point in time, certainly our cash end is more than sufficient to fund us well into 2015, if not beyond.

Larry Haimovitch – HMTC

Okay great. Thank you very much.

Operator

Thank you. We have no further questions in queue at this time. I'd like to turn the floor back over to management for any additional remarks.

John Sperzel

I'd just like to thank everyone for participating in today’s call and look forward to sharing additional updates and results in future quarters. Thank you very much and have a great day.

Operator

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

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