Barry Weiner - President Jim O'Brien - Executive Vice President of Finance David Goldberg - Vice President of Corporate Development.
Bill Bonello - Craig-Hallum Pat Gallagher - Laidlaw Norman Hale - Stifel.
Good morning, and welcome to the Enzo Biochem Incorporated Second Quarter 2016 Operating Results Conference Call. I will now read the company's Safe Harbor statement.
Except for historical information, the matters discussed in this news release may be considered forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended.
Such statements include declarations regarding the intent, belief or current expectations of the company and its management, including those related to cash flow, gross margins, revenues and expenses are dependent on a number of factors outside of the control of the company, including, inter alia, the markets for the company's products and services, cost of goods and services, other expenses, government regulations, litigations and general business conditions.
See risk factors in the company's Form 10-K for the fiscal year ended July 31, 2015. Investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve a number of risks and uncertainties that could materially affect actual results.
The company disclaims any obligation to update any forward-looking statement as a result of developments occurring after the date of this conference call. During this conference call, the company may refer to EBITDA, a non-GAAP measure.
EBITDA is not and should not be considered an alternative to net loss, loss from operations or any other measure for determining operating performance. The company has provided a reconciliation of the difference to GAAP on its website, www.enzo.com and in the press release issued last night. Our speaker today is Barry Weiner, President.
At this time, all participants have been placed on listen-only mode and the floor will be opened for questions and comments following the presentation. I would now like to turn the floor over to your host. Mr. Weiner, the floor is yours..
Good morning and thank you for joining us today. On the call with me is Jim O'Brien, our Executive Vice President of Finance; as well as David Goldberg, our Vice President of Corporate Development. We issued our 2016 second quarter press release last night and you may view it on enzo.com if you haven’t had a chance to take a look at it yet.
The second quarter of fiscal 2016 has been one of exceptional progress. Our continued evolution to an integrated company heavily embedded in molecular diagnostic is very evident in all aspects of our operations.
What is especially notable is that its impact is being felt in all areas of our business, that is research and development, marketing and distribution and in our clinical laboratory. The dynamic approach that is helped us to evolve into an integrated entity continues to yield positive results.
Our performance this past quarter underscores the concept that are focused on advanced, low cost, high performing and easily adaptable molecular diagnostics is having an impact and is becoming the defining segment of our business.
As we have stated before the segments of the diagnostic market continue to be the fastest growing, growth has been estimated twice that of the other diagnostic segments. It is providing breakthrough opportunities and identifying disease and pointing away to be more effective, treatment cycles and monitoring.
But as we have stated before this rapid growth is coming at a time with our difficult economics that are reducing margin for clinical labs or bearing the brunt of the increased costs that are coinciding with decreased reimbursements. Enzo Biochem has been at the forefront of developing solutions to this dilemma.
We have developed a pipeline of products, several of which I will detail in a few minutes, that should produce a flow of solutions to clinical labs and physicians alike that are rooted in fundamental principles, that is producing products and services that are high performing, easily adaptable to current processes and perhaps most important cost efficient.
Our pioneering work in genomics in nucleic acid amplification detection has uniquely positioned us to play an important role in molecular medicine.
It is also now provided us with the capital structure needed to continue to execute on our business strategy and this is evidence by the continued success in defending our proprietary intellectual property. I will return to what we are doing shortly, and provide a quick look ahead.
But first, I'd like to review the financial results of the second quarter. Revenue for the period were up year-over-year by 6% with Enzo Clinical Labs posting a 19% gain. The lab revenue increase reflects its growing focus on higher margin molecular testing services.
At the same time, the margin expansion is also assisted by continually adding in-house developed technologies and products to menu of assays that are performing.
Our women's health emphasis continues to manifest itself not only in the widening of our services menu, but in the announcement we made earlier today consuming our latest diagnostical achievement which is the submission to the New York State Department of Health for approval of our second AmpiProbe based assay and the first of what we believe will be several that will be focused on women’s health infectious diseases.
Additionally, margins and operating income continue to be aided by targeted capital investment to heightened efficiency, this includes areas of data storage and analysis, billing and collections, communications to name a few.
Enzo Life Sciences despite a decline in product revenues and a drop in royalty income, remain profitable with steady gross margins and positive cash flow.
As we continue to morph our products division from a research based focused to a molecular diagnostic one, we are deemphasizing our lower margin, academically oriented Life Science products and we are shifting our manufacturing and marketing focus toward high value, clinically oriented products.
As our flow of diagnostic products from our research and development group grows more robust, we will see concurrent increases in the focus of our integrated marketing and services team toward clinical laboratory customers.
Our royalty declined quarter-over-quarter is directly attributable to a reduction in the sales of covered products by our licensee QIAGEN. On a consolidated basis, gross margin advanced 8% to $10.8 million, as a percentage of revenues it increased 100 basis points to 44%.
SG&A was up about 17%, but this was the result of non-reoccurring, contested proxy related expenses, while R&D was up slightly by about 3%. While we continue to make significant advances technologically, Enzo remains one of the most efficient users of R&D capital with outstanding results.
Legal fees largely associated with our infringement cases, were actually lower year-over-year by approximately 14%. We also continue to achieve notable success on the legal settlement front, receiving in this quarter alone over $6 million from Agilent and $7 million from PerkinElmer.
In Delaware with the settlement of the Agilent action, eight of our original eleven cases remained adjudicated. In total, the quarters reported legal settlements and that were $11.7 million after taking into account the $1.5 million charge related to achieving certain financial milestones in the OIG settlement, which was concluded last fiscal year.
Operating income amounted to $7.5 million compared to a year ago loss of $3.9 million, an improvement of $11.4 million. Net income amounted to $6.8 million or $0.15 per fully diluted, versus a year ago loss of over $4 million, or a loss per share of $0.09.
On an adjusted basis, which excludes legal settlements, contested proxy expenses and other non-reoccurring expenses, non-GAAP net earnings per share was a loss of $0.07 compared to a loss of $0.09 in the prior year period and non-GAAP adjusted EBITDA was a loss of $2.1 million compared to a loss of $3.2 million a year ago, reflecting improved core business across of Enzo.
Cash generated by operations in the quarter amounted $6.9 million, again, reflecting solid performance of the operating segments and cash received from legal settlements. Cash generated by operations for the current fiscal year is now more than $20 million.
Again, this quarter was also invested – we also invested nearly 500,000 in capital, information of technology solutions, new diagnostics equipment and other capital expenditures related to developmental projects designed to enhance our capabilities and promote profitability. Overall, cash flow has remained strong, and so as our balance sheet.
At January 31, cash and cash equivalents amounted to $37 million, double the amount on hand at the fiscal 2015 year end. Working capital amounted to almost $35 million. More specifically, patent related legal settlements over the last two years have amounted to nearly $48 million with net proceeds to Enzo of almost $36 million.
Turning briefly to the segment results. Clinical Labs increased revenues by $2.8 million to $17.5 million, or a 19% over the prior year. The increase in molecular focus, operational enhancements and process improvements I mentioned a few minutes ago, continue to have a marked effect on gross margins, which increased to 40% from 37%.
Clinical Lab process improvement also is reflected in increased collections with bad debt as a percentage of revenues roughly half of what it was a year ago, 2.6% versus 4.2%.
For an additional legal charge of $1.5 million due to achieving the milestones I commented on to the OIG, the lab had an operating profit of 800,000 for the second fiscal quarter.
At Enzo Life Sciences, product revenues were $6.6 million, as we continue to refocus our product efforts towards molecular, margins remain steady at 54% for both the second quarter of '16 and the like year ago period.
Enzo continues to invest in upgrading existing manufacturing space to production facilities to accommodate the increased output expected from our new product flow. It is also transforming its sales and marketing to the clinically oriented product room, while increasing sales that can address this particular market.
Poor economic conditions in Europe and unfavorable currency exchange valuations did affect results. Though Life Sciences continues to make headwind and trimming lower yielding products from its mix, while increasing the share of revenues accounted for by higher margin, more profitable products.
Apart from the previously noted legal settlements, which are included in this segment – this current segment results of $13.2 million, the quarters operating profit was nearly 400,000 compared with $1.3 million a year ago. This segment also has remained cash flow positive.
Overall the second fiscal quarter of 2016 was a very striking favorable one that underscores the positive direction in which we have embarked. Both operating segments continue to be profitable, generate cash and are executing on Enzo's long-term business plan and corporate strategy.
The quarter’s results again reflect the progress we have made to date to meet the needs of the demanding and fast moving medical markets. And especially the increasing benefits realized from our ongoing strategic program integrating Life Sciences and Clinical Labs.
As we said before, it is given us the best of both possible worlds, a developmental and skilled global manufacturing marketing unit in Enzo Life Sciences, combined with the practical knowledge and application of a world class diagnostic team fully entrenched and recognized in and outside its market territory in Enzo clinical laboratories.
In closing, I'd like to reiterate Enzo's corporate strategy for those on the call who may be new to Enzo. As a fully integrated diagnostic company, Enzo is structured to capitalize upon the ongoing reimbursement pressures in the molecular diagnostics market.
We are structure to deliver on the development and product of cost effective, high performing, easily adaptable products and services that could potentially provide a 30% to 50% savings to the current molecular diagnostic cost for clinical laboratories.
We are prepared to either self test in platforms to independent labs or depending on their preference, process the assays on a reference basis. New York State Department of Health Licenses [ph] provides us a widely recognized and highly regarded imperator, that allow us to have crucial national reach.
At the same time, our accreditations and global footprint provide us with a worldwide reach. Our strategy of designing molecular diagnostic assays and test at reduced cost that are highly effective positions Enzo as a new important factor in the molecular diagnostics market.
Our capabilities extend to biotech where we are developing technology and platform that serve as the engines for innovative product development.
In molecular diagnostic we are actively developing, formatting and manufacturing high performance products in a large scale and at the clinical services area our state of the art clinical lab that provides a company with meaningful insight knowledge allowing us to commercialize these high value diagnostic assays.
These trends differentiate Enzo in another important way. Namely in today's competitive market environment there are numerous biotech molecular diagnostics and clinical services companies, what they lack typically is the necessary operating structure in resources to effectively meet the challenges of this fast growing and changing molecular arena.
Our intellectual property strength provides us with an economic advantage, since we uniquely own a basic patents to compete successfully in today's world, we need not pay royalties to a third party. Moreover, our company has the extraordinary capacity built out over the years to move from concept to commercialization.
It requires an innovative culture, combined with a strong intellectual property position, a solid technology platform, manufacturing capability and an in-house ability to validate technology, as well as deliver quality products and services. Few of any companies can match our integrated approach.
Our strategy is enabling us to deliver cost effective, high performance, easily adaptable products and services.
This will provide potential savings in the current molecular diagnostic market that could be very substantial, could amount to almost 30% to 50% cost reduction with now diminution in quality with anything and also carry with them superior attributes.
This is no smaller accomplishment and we believe that this will be a terrific asset to laboratories around the country who are calumny [ph] being squeezed for tight margins. As for their superior quality, these tests will translate because of the ability to use smaller sample sizes that allows us to handle and reduce preparation costs.
The systems that we have developed particular AmpiProbe have an ability to run up to 30 assays simultaneously from a single specimen. They have enhanced sensitivity over a competition, they are 100% compatible with existing FDA approved DCR technologies.
They are flexible, adaptable to work with any open - any but almost dedicated systems on the market and they are highly adaptable, so they will fit readily and easily into a laboratory workflow. If we review where we are, there are four basic issues that stands out.
Our legal actions continue to progress towards inclusions, and are moving ahead with decidedly favorable outcomes that spurned Delaware. Second, Enzo Clinical Labs is enjoying accelerating growth.
Third, Life Science is smoothly transitioning to a high margin producer in efficient marketer of assay, while gearing up for a greater role and producing and selling our proprietary molecular systems and technologies. Four, the development of molecular diagnostic products and the accompanying assays is progressing extremely well.
As to this last point, I'd like to remind you o what we consider our competitive advantage an opportunity. The pipeline of products under development today encompasses at least 9 major assays, including an extensive women's health panel that we anticipate portions will be or could be available in 2016.
The women's health sector is where our company expertise has become exceptionally notable. Our Flowscript and AmpiProbe platforms have been strengthened by a number of key tests under development.
We anticipate having available a fertility assay, a cardiac marker and our test in women's health panel that will encompass a 11 different tests in one assay in the near future. On that score, we announced today the submission to the Department of Health in New York State, our newest AmpiProbe - our newest AmpiProbe based assay.
It is known as AmpiProbe Candidiasis. It is a multiplex assay, designed to identify the presence of the most common species of Candida from a single vaginal swab. Its estimated industry wide that the number of tests for this type of indication run about $10 million per year with reoccurrence rate of about 30%.
The AmpiProbe Candidiasis test is the second completed validation using the company's proprietary nucleic amplification and detection technology and the third submission in less than a year.
When approved, it will further expand the line of lower cost diagnostic products under development at Enzo to address the critical needs of clinical labs which I mentioned earlier.
Over the coming months, we anticipate submitting additional assays based on AmpiProbe for women's health infectious conditions, as well for the detection of other infectious diseases. In addition, we will be debuting at the United States and Canadian Academy of Pathology annual meetings in Seattle next week, in new line of products.
Moreover, we expect to rollout a line of products designed to aid pathologist in distinguishing the characteristics of various tumors from biopsies specimens. These products like all of those in our pipeline adhere to the fundamental tenant of high performance, easy adaptability and cost effectiveness.
We are incorporating these products in-house and into clinical labs and our executive team has been actively reaching out to key opinion leaders in the immunopathology field to present these exciting solutions. This continues to be a very exciting time for Enzo and one that we believe holds important and immense promise.
On that note, I would like to turn the floor over for questions..
Thank you. The floor is now open for questions. [Operator Instructions] The first question comes from the line of Bill Bonello of Craig-Hallum..
Good morning, guys. Congratulations on what looked to be the best quarters since I've covered you. Couple of questions, so you had some great success penetrating large New York area, IVF practices, maybe acting essentially as kind of a channel partner for some of the NIPT specialty labs have been getting the pull through business as well.
I guess a two part question on that.
One, are there more IVF practices that you could add and then secondly, if that model transferable to other specialties, for instance could you be sort of the channel partner for some of the specialty cancer labs or the auto immune labs et cetera?.
We are emerging as a formidable entity in the women's health space, in the Tri-State New York region. Women's health has been a core focus of Enzo for many, many years, dating back to the original HPV testing systems, which we have licensed now out to QIAGEN, as well as other technologies that we've licensed to others.
Much of our clinical lab growth and success is coming from increasing our penetration into the market, because we are emerging as one of the last most formidable, I would suggest the full service labs that can provide boutique service capability with a full menu opportunity, and at the same time give a logistical presence for that I believe is unparalleled in our industry.
And as we all realize, the clinical laboratory market and industry is a service business, and we pride ourselves on the fact that we provide an excellent level of service to our clients. That being said, we have been able to become a provider of choice for many of the women's health practices, specifically those that focus on in vitro fertilization.
These are types of practices which tend to have scale, they tend to require intensive testing capabilities and they require a very strategic and strong logistical presence.
As a result of that, I believe Enzo has become the go-to-laboratory, not only for the ability to basically provide test that we provide, but to be a logistical provider and support for the testing that is being developed by others in the industry.
We in many ways provide the logistics that are not capable or available to a laboratory that is a nationwide one-off test or two-off test provider, we have a very strong relationship with our accounts, and thus the accounts are coming to us because we provide the logistical support that can help them in not only making their practices more efficient and economical, but we get – we are able to provide the menus to these practices that are relatively agnostic in their approach and we provide complementary services provided by many providers out there.
Specifically, in the women's health area, in the area of NIPT, in prenatal genetics, we are developing a very dominant position in our market. We have a good number of the IVF practices already on board. I would say we have - perhaps some majority of the larger ones on board.
There are others which are in the process of engaging with us, as a result of our reputation. So we think we will growth in that field and we think we will emerge as a dominant developer and presenter of technology and products to these entities.
The second part of the question is a translatable, specifically to the oncology market and the answer is absolutely yes.
And the reason I say that, is as we are aware the clinical laboratory business is emerging as a entity or a business structure that not only provides diagnostic outcomes, but it is a source of data accumulation, generation and translation.
Big data has moved to the medical side of the marketplace and its movement is taking place through the clinical laboratory market.
As a result oncology, which is you know, a very emerging market place from the numbers of new therapeutics that are coming forth with a better understanding of genetic, understandings and profilings contributing to the methods of treatment, the ability to have the linkage with Enzo to utilize our main frame for digestion, for accumulation for dissemination of data and results is very strong.
We have a core client base that basically is integrated on an IT level which cannot readily be duplicated by the developers and the manufacturers of one-off test. And as a result, parties are again looking to team up with us, to utilize our logistics, our IT, our billing, our relationships with the providers, which are very strong in this area.
And so in many ways our strength is the fact that we are highly integrated to the individual doctor. So we make the process of running a diagnostic more streamlined, more efficient, more cost effective, and easier. So we do believe and we are seeing this approach.
We are in dialogue with many different parties today who are interested in teaming up with us to ask us to be the provider of their developed systems to our base. And again when you think about it today in our region we have the potential to be inside between 2 and 4000 physicians everyday in our region.
That is an extremely strong marketing capability and one that we are developing and we are watching now start to reap benefits at the clinical laboratory. The other one we didn’t answer, but I think it’s a very important question..
Yes, no that’s very helpful. And then just sort of thinking off there, you highlighted your add [ph] years for regional strength.
Now that you've built up a significant molecular testing capability, what are your thoughts on so to expansion in terms of your kind of capture area in serving as a reference lab, would you want to move beyond the greater New York area and try and bring in reference business there or is the opportunity really to stay focused on your market and interact more volume through there?.
The strategic plan for the corporation is to move Enzo Clinical Labs into a national reference laboratory, specialty testing. We believe we will be able to do that with some partnerships and extension of our businesses through other labs around the country, such that we can work on the principle of providing low cost testing solutions.
Our goal is not just to be another reference lab, most of the reference work in the industry for parties that sent out results in negative – not any margin at all for the test that are sent out, one of the key problems for clinical labs around the country, there are about 7500 independent labs around the United Sates today, is that they don’t have the capabilities to sophistication to be able to perform the types of sets today, they are being in demand in the molecular space.
We hope be able to provide low cost solutions to these laboratories, either as a provider of reagents and systems, if they have the internal capabilities to integrate and perform these.
But if not, we will offer them the ability to provide a service, as you suggest a national reference service at a price point for which they will be able to have a marginal return and that is key. Our goal here is to provide either reagents and systems or services that will allow laboratories to make a profit where today they are unable to do so.
And I think it is a very compelling formulae and this based on the technology and the ability of our systems to be able to provide a more efficient testing methodology for these entities..
Excellent. And a couple other things.
So if you exclude the proxy costs, which are obviously one time in nature, SG&A expense was essentially flat on a year-over-year basis? What are your thoughts at this point in terms of the need for incremental investment versus sort of being able to leverage the current cost structure?.
Bill, its Jim O'Brien, here. I think that we leverage our current cost structure and expand the business without tremendous amount of additional new sources needed to execute on our strategy. So I would expect the SG&A expenses to be relatively flat over the short term, as we continue to execute on the strategy..
Excellent. And then just you're building up a very nice cash balance, can you – two things, can you tell us what operating cash flow would have been, excluding the inflow from the – the inflow and outflow from the legal settlements? And then what are your thoughts are of kind of sources and uses of cash going forward are..
So we can look into that and get back to you. I think the quick answer here is that, for a number of quarters now, both the Life Science product business and the Clinical Lab have been generating positive cash flow. I would expect that trend to continue. What's absorbing cash today is our legal expenses and defending our patent case [ph] primarily.
So it’s transparent on the income statement, as well as on the cash flow, that the businesses are operating in a very positive manner and we expect that trend to continue. I would say that, as the case is what happens with the real case is, you have lumpy expenses when it comes to export, when this is and so forth that happened and the patent case.
And so it’s difficult to predict quarter-by-quarter what the run rate of cash flow would be for those expenses. But I think what you've been seeing in the last few quarters, ex the legal settlements is something that you can anticipate going forward..
Okay.
So probably just so we know, I mean, probably kind of a modest, or in a modest cash burn, ex-legal, would you say not ex-legal, ongoing legal expenses, but ex-settlements?.
Correct, given the output of legal expenses, but I would expect the operating segments to continue to bring in cash..
Okay. Perfect, excellent. Thank you so much..
Your next question comes from the line of Pat Gallagher of Laidlaw..
Hi, Barry. And congratulations. Great quarter and great progress.
Could you we chat just a little bit more about the apical pipeline, I know that through the end of the year you want to have a number of additional tests? But maybe just looking out over the next 18 to 24 months, will that be enough time to get the full women's health panel of a 11 test completed, give or take? And the clinical level, where do you think you really start to gain traction, as it’s having two or three panels available, is one enough? I am just trying to understand $10 million test a year I imagine that’s pretty good start, but maybe you can give us a little more color on that?.
Certainly. The key product I mean, every product is important, but the product that could have a transformational approach to it is our women's health panel. As we've spoken in the past, it’s a panel that will have up to maybe 14 or 16 different analytes in it.
It’s interesting, the press release we put forth today on the Candidiasis products, it’s really a multiple targeted analyte, meaning, it targets multiple specimens, its not just one target, it has multiple targets in it. We look at the women's health panel as consisting of approximately 3 categories of test in it with different types of diseases.
This one filed recently is one group of that. We have tow or three other groups which are following now. We will hopefully start to see more of these emerge over the next year. We will begin to offer these as they attain approval. We are not waiting for the full panel to be approved before we go out.
But the biggest value general will be when the full panel is ready and we hope to start to see that within the next year. We have different tests that are emerging. We talked a little bit about a cardiac marker test which is just about ready for review. We have a fertility test, which is a little bit unique, which is almost ready for review.
We have a variety of other products coming out as well, particularly in the immunohistochemistry side, vis-à-vis the product that I alluded to in my comments earlier. So we are in a sense refilling our pipeline with clinically directed products after reducing our skews in Life Sciences.
I mean, when you look at the dip off in Life Science revenues over the last quarter, much of that has to do with a reduction of low margin entities to create room in the manufacturing entity, to be able to produce these higher margin products. And we believe this future pipeline will drive future revenue growth significantly.
So right now what is happening is we have this pipeline under development, products in various stages, we have been carving out and reshaping the Life Sciences entity to be able to support the manufacturer of these products. We've been reshaping the marketing, sales activity as we morph from academic to clinical.
So what we did at the clinical lab over the last two years is now being implemented at Life Sciences. We've gone a routine testing lab to one that is almost 50-50 molecular esoteric test compared to routine test.
We are trying to accomplish the same by designing a methodology for our Life Sciences division that will allow it to be supportive to the production of these clinically driven tests..
That’s great. Thank you. And on that front, what do you think the best way to get the word out is, I mean, who would marketing look for this, because it is different and going to academics. So obviously the message is very powerful.
But what's the best way to let the world know that you're open for business?.
Right now we have been approaching key opinion leaders around the country, exceeding our products, I mean, adoption and change in the medical community is a process. It works by developing an infrastructure of support to key opinion leaders. We are putting our test into different laboratories and having them to test them out.
We do have a full marketing change that is as I mentioned at the trade shows, that will be emerging with the campaign to address the key issues that are confronting the industry as a whole.
We are also working to the insurance providers, and that is an important outlet, because what we are offering is methodology that potentially save money for them, save money for the patient ultimately, and provide easier outcomes for physicians.
So it’s a multi-channel approach dealing with the end users which are the orders that physicians dealing with the insurance providers, dealing with institutions. But the key message here is economics, we believe we have a methodology that is much lower in cost and will take cost out of the system.
At the same time provide increased marginal return to those that employ the technology as well as ourselves..
That’s very helpful. Thank you.
A quick question on the lab, as Enzo becomes - considered a reference lab for some of these specialty tests, how much capacity do you have, can you go – in other words, how long can you go before you have to add some incremental capacity?.
I think that we've got a significant capacity in our lab, leveraging our process improvements, leveraging the expertise that we have in the leadership team there. So I think we can easily double the size of that, doubling the cost in the lab.
So I think there is an enormous opportunity within our infrastructure and the company that we built in the last couple of years to expand quite nicely, it will have incremental growth and that can be reflected right to the bottom line..
You have to remember also that the clinical lab is a fixed overhead business. It’s very modulate, as we have that core operations actually honing in a very efficient way right now. As our needs increase, you're adding modules to instrumentation, much of it is automated. So that the efficiencies of scale should come into play as we move forward.
So we think we have significant capacity today to really drive that business..
Thank you. And one final question, real quickly on the legal front. It’s been a very well managed process, I think your legal partner has done a great job, being creative and tactically, as we look forward on that front, what is the timeline for this potentially go-to-trial if people don’t settle.
I am trying to put sort of a bookend out there where, not that there is any guarantees and not that you'll comment on it, but if a trial could potentially start on ex-date, maybe people will be more willing to settle ahead of that.
So I am just trying to make sure I've got that straight?.
As you are aware the legal process has tremendous ambiguity and tremendous liberalness and time schedule. What we understand the system in the majority of these cases are Delaware cases. Delaware is noted for its somewhat more rapid track than other states in the United States.
It is our understanding that these cases have gotten into level now where we can anticipate trial dates sometime either right before - or right after the first of the year, that’s next calendar year. We believe we are in a position right now. There are still – their positions and discovery [indiscernible] wittiness’s to be done.
There are some re-judgments that need to be done. This probably will be accomplished by the summer and subsequent to that we anticipate trial date. It is not – I mean, considering the system as a whole, this is moved very efficiently, as you can see from the 11 cases that were initially out there, settlements have taken place.
This is – I think the time frame is profitable now as we see trial dates emerging some time right after the first of the year..
Thanks very much. I understand there is no guarantees, but just trying to put some bookends around it. Thanks very much, guys, again….
Thank you..
Your next question comes from the line of Norman Hale of Stifel..
Good morning..
Good morning..
Morning.
First question on the AmpiProbe product for the HCV viral load, has that product actually started selling?.
We actually have it running in our clinical laboratory. We have yet to release it yet, because it required a certain level of correlation and optimization, which is being done. But it is almost ready to begin to be utilized and integrated into our portfolio..
Okay. So it’s coming….
It’s coming soon..
Okay. All right. On the women's health panel, which obviously is very exciting area, you guys are working in.
The gross margin for those products will they be similar to or greater that of the HCV product?.
You know, they are certainly go be a lot a higher than what we are running in the company today. We haven’t previously disclosed that, but they are absolutely higher margin products because we control the cost, we're developing them internally.
So you could expect much higher margin in the company as those molecular diagnostic products are introduced..
I think you can anticipate that the margins will be somewhat similar, again, we are – our own manufacturers. So we control our manufacturing costs. As a result, the basic products will all fall within a similar marginal return profile..
Okay.
And once you get some of these women's health panel products approved and out there in the marketplace, do you think that enhances your position relative to setting up joint ventures with some other larger companies?.
We are already in dialogue, I mean, as our system gets better recognized, that we're presenting in a different conferences today, we have been engaged in dialogue for a period of time with different parties over different opportunities.
So the answer is fundamentally yes, but in response it is something that we are continuously exploring and attempting to put into place..
Okay. All right. I guess, my question is, once you have a suite of products that are available I mean, that has to enhance your importance and marketability of the product, because….
Oh! Definitely....
Yes, for suite of product, okay. And I guess from what you just described, the various women's health products are yet to be coming out, its not like they are all going to come out at the same time, they are going to coming out sequentially over some period of time, is that….
That is correct..
Okay..
Yes, it is..
And when would you think that – let me ask this question, you have a group of product that you're currently working on, are you adding to that group, is your R&D department, are they coming up with new potential products that fit within that category?.
Yes, they are. We – as we mentioned in the past, we have not only the AmpiProbe, the women's health panel, I mean, within the AmpiProbe line we are developing a multitude of products that can address not only women's health issues, but other infectious disease issues, cancer marker et cetera. But we as a company have multiple platforms.
You are aware of our Flowscript platform. We have a platform for immunohistochemistry. So we are exploring and developing products that will address low cost solutions in different sectors, not just the women's health infectious disease area.
So we have a fairly robust pipeline in process right now and as a result I think you will start to see not only women's health products emerge, but products that will address other platform technologies as well..
And I know one of the key items that make sure - products in the marketplace make them competitive, obviously is going to be the pricing issues.
But since I am layman, I don’t have a familiar [ph] background, is the effectiveness of the product another selling point, beyond the pricing of product?.
I am sorry, could you repeat that please?.
Yes, what I am saying is, obviously what we're looking for here is, what's the competitive advantage to using Enzo products and obviously the first thing is you know, you're going deal with the prices thing and an attractive price and still maintain a decent margin.
But in addition to that, is there in terms of the effectiveness of the product, is there anything additional that you guys bring to table?.
Yes. Number one, I mean, cost is the paramount issue as we've been promoting and that’s key for laboratory.
Technologically, we are able to panel, and this is part of the cost efficiency, because of the dynamics of the technology we are able to run more than one analyte on a given specimen, which will contribute to the overall efficiency of the process.
We – the whole design of this particular approach and I am referring to the AmpiProbe approach, is to utilize a higher level of sensitivity and translate that to economics. Now there are – the high level of sensitivity is not necessary compared to our competitors for many products out there.
But there are certain areas where it may have some unique capabilities. As an example, I will point to, one, that’s in the area of Hepatitis-C, in the last two years drugs have emerged that literally are claiming a cure for Hepatitis-C. That is based on the amount of virus in the system.
If we are able to confirm and delineate that there is no viral load left in an individual, it really reiterates I think the claims of some of these therapeutic products. So there are some benefits which may become apparent with this technology. Overall, the design has been to be completely transparent in terms of our competitive capability.
We are marketing these products on a cost basis, they are high quality, they are – they don’t disrupt the work flow of a laboratory.
And what we are suggesting is that there are many technological assets, but the real issue here is that you can move to our system, without capital expenditure, without change of skill set within the laboratory and utilize a lower cost system to accomplish your testing needs and goals and at the end result make money..
That’s great. Okay, let's move on, for the HBV product - that AmpiProbe product which you say expected availability is 2017….
Right..
Is that expected, would you say that would be first half or second half of 2017?.
It will probably be the first half..
Okay.
And same question for the HIV AmpiProbe product?.
We are targeting – we are attempting to target them simultaneously..
Okay. Excellent. And Barry, let's guess for - kind of just assume it out of thin air, if you got another $30 million or $40 million bucks from legal settlements before this year was completed, which should bring your cash balance up to maybe $65 million $70 million bucks, or greater.
How would that change your budgetary process going into year 2017?.
We need to invest more behind the development of our systems to get them into the market in a more rapid pace. So I can certainly see enhanced investment in our research and development team pushing out these panels in a more rapid base.
As you are – as you know our history, we've been - we are relatively conservative in how we have invested behind our products. We believe we have strong platforms. We have viable products and we have a very proven concept right now. I think it [indiscernible] for our shareholders to drive those systems as quickly as we can into the marketplace.
And we will certainly invest more behind it. I think that is the key issue that we have to focus on it at this point in time..
Okay. Excellent.
And one last question relative to the legal issues, the case that was originally in Connecticut, which was appealed, the Life Sciences appeal, can you make any comments about the status of that particularly litigation?.
It’s in the form of an appeal to be applied. As you know that case is bounced back in forth between the second circuit and the circuit core it was now going to be bounced back to the second circuit again. It is not over, it is just the process and there is a very long arguer’s process that has had many ups and downs.
It is a case we still believe very strongly and we will continue to pursue it as long as we are capable of pursuing it..
Okay. Excellent. That’s all I had. You guys are doing a good job. Thank you very much..
Thank you..
Thank you..
There appears to be no further questions at this time. I'll now turn the call to Barry Weiner for any additional or closing remarks..
Thank you for joining us today. As I mentioned, the quarter has been a quarter of significant progress and accomplishment. I think we have set the stage now for really looking towards growth in this corporation and delivery of some unique products to the marketplace.
We look forward to our next report, which will be in June and we hope to be able to report further progress at that time. Thank you..
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