Cancer Genetics' (CGIX) CEO Panna Sharma on Q1 2014 Results - Earnings Call Transcript

May.15.14 | About: Cancer Genetics, (CGIX)

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Cancer Genetics Inc. (NASDAQ:CGIX)

Q1 2014 Earnings Conference Call

May 15, 2014 4:30 PM ET


Paul Kuntz – IR

Panna Sharma – President and CEO

Edward Sitar – CFO and Treasurer


Ben Haynor – Feltl and Company

Ram Selvaraju – Aegis Capital

Sung Ji Nam – Cantor

Thomas Pfister – RedChip

Brooks O’Neil – Dougherty & Company


Good day, ladies and gentlemen and welcome to the Cancer Genetics Inc. First Quarter 2014 Earnings Conference Call. As a reminder, this conference is being recorded.

I would now like to introduce your host for today’s conference Paul Kuntz, Investor Relations Manager for Cancer Genetics. Paul, please go ahead.

Paul Kuntz

Thank you, Shay. And thank you for joining us for Cancer Genetics first quarter 2014 earnings conference call. On the call today are Panna Sharma, the company’s President and Chief Executive Officer; and Ed Sitar, the Chief Financial Officer.

Cancer Genetics is traded on the NASDAQ as CGIX. The company issued a news release this morning detailing its first quarter financial results and the agreement to acquire BioServe India. Following the Safe Harbor Statement, Panna will provide an overview of the first quarter, recent events and company activity. Mr. Ed Sitar will then provide a summary of the first quarter financial results. Next, Panna will discuss the acquisition of BioServe India and future plans and strategic activity followed by a question-and-answer session.

Before we begin I like to remind everyone that various remarks about future expectation, plans and prospects constitute forward-looking statements for purposes of Safe Harbor provisions under the Private Securities Litigation Reform Act of 1995. Cancer Genetics cautions that these forward-looking statements are subject to risks and uncertainties that may cause their actual results to differ materially from those indicated. Any forward-looking statements made on this conference call speak only as of today’s date Thursday, May 15, 2014 and Cancer Genetics do intend to update any of these forward-looking statements to reflect events or circumstances that occur after today’s date.

This conference call is being recorded for audio rebroadcast on Cancer Genetics website at All participants on this call will be in listen-only mode. The call will be followed by a question-and-answer session. It is now my pleasure to now introduce Cancer Genetics President and CEO, Mr. Panna Sharma.

Panna Sharma

Thank you, Paul. Hello and good morning to everyone. Welcome all of you to our first quarter earnings call. We continue at CGI to have a busy quarter and year building the company and putting in place the fundamentals for world class global company in cancer diagnostics and management. This morning we released a strategic and exciting news that we’ve reached an agreement to acquire and control all the stock in BioServe India a premier genomic services based in Hyderabad.

The company has capabilities in next generation sequencing and oncology and genotyping and a high value high invest in research, pharma and clinical diagnostics. We will be paying a total of $1.9 million U.S. in consideration, $1.65 million in cancer genetics stock and roughly $250,000 in cash and get assumption. So it’s an very well structured deal and I would like to take a few moments to talk in more detail about the strategy of the transaction that we announced this morning and what that means for the acceleration of our business and the value to our shareholders.

The acquisition of BioServe India is well aligned with our goal of pursuing selective strategic acquisitions that enhance our positioning, diversify our business model and give us exposure to additional high quality revenue. We also fully expect that the transaction will have immediate positive impact once we close the acquisition during the third quarter and an accretive effect to our EPS the following year.

The healthcare market in India, as many of you know and even more notably in diagnostics is experiencing rapid growth and high consumer demand. Industry analyst such as PM Live Pharmaceutical Industry News, KPMG, PwC and others note that the total Indian healthcare market is worth of $65 billion last year in 2013, but it’s projected to increase to approximately a $100 billion next year in 2015.

And some of the key success factors for India are a large pool of qualified clinicians, scientists, engineers, growing institutional and clinical infrastructure, upcoming other competitive research facilities, diversified patient pools and access to bioinformatics, clinical information and samples. Participating in this market for BioServe India can be an accelerator for our long term vision of impacting and personalizing cancer diagnostics globally and gives us a great opportunity to hit the ground running in a high gross market.

Over the past year we’ve got to know the BioServe team and management understand their capabilities and feel very comfortable and collaborating with them to bring the CGI brand into India. Obviously this is not an agreement we take lightly since it’s our first acquisition as a public company, but since we come to an agreement a few days ago we’ve been working hard towards closing this transaction which we expect again will happen during the third quarter, of course this will be subject to customer at closing conditions, government approvals in India and other closing items detailed in our Q.

So like their strategic acquisitions our component of our growth strategic will help us drive scale, capability development and most importantly help us fulfill our mission to personalize the treatment of cancer. Let me also take a few moments to update you and some of the other very important accomplishments since our last call. First in kidney cancer, we continue to rapidly develop our program there and we presented new data at the AACR showing that, a very targeted 16 genomic alternations could potentially serve a biomarkers for the prediction, prognosis, identification in metastasis in renal cell carcinoma.

Metastatic renal cell carcinoma is a serious issue; it’s very aggressive has a very poor prognosis and a very low five year survival rate about 8% to 9%. Diagnosing this earlier and being able to predict the metastasis earlier in patients, its key to improving overall survival outcomes and getting people to the right treatment option. We developed this indication and this test in conjunction with Sloan-Kettering, we planned on having additional data this year and continuing to build our franchise in kidney cancer a highly underserved category with about 60,000 new patients a year that are diagnosed just in the U.S. and growing at about 2% to 3% a year.

We see a significant need in providing comprehensive genomic testing in kidney cancer and renal cell carcinoma. Currently we know their genomic test out there that I’m aware of this currently targeting critical need and this fits well with our very targeted disease focused strategy. We also launched a genetic test for detecting mutations in calreticulin gene CALR and one of the few commercial laboratories in the U.S. to offer this test both CLIA and New York will continue to extend our development of knowledge in myeloproliferative neoplasms which are blood cancers that have the potential to evolve into acute leukemias.

In addition patients with the CALR mutation have a very favorable disease outcome potentially longer survival and a different prognosis in patients with other biomarker profiles. Therefore the results of this test have significant implications in predicting the patients outlook and therefore also selections for trials and potential monitoring. So this test are not proprietary’s already helped us open doors and discussion with Hemox with clinical trial customers and community oncologist looking to better monitor and understand the patients potential progression and overall risk profile.

We’ve also presented and promoted FHACT, which is our test for cervical cancer at the American Congress of Obstetrics and Gynecology at their Annual Clinical Meeting is the premier clinical gynecological conference in the United States. And as you know we have lot of expectations for FHACT, FHACT is a non-invasive genomic test that can identify and stratify the lesions caused by persistent HPV infection. This test provides physicians and OBGYN’s the crucial information in making treatment decisions and understand pre-cancer and cancerous cervical cancer.

We continue to think this test can significantly reduce the number of cloposcopies and cervical biopsies in the U.S. with their leasing earlier 2 million to 2.5 million of this procedure is done and less than 20% of these actual become cancer pre-cancers. So imagine being able to now aviate the need for 80% of those cloposcopies. We think this continues to be blockbuster potential, so a non-invasive test works directly from the running PAP smear and it plays a major role improving patient outcome with a minimal invasive test and reducing healthcare burden involve in cervical cancer management.

We also expanded our portfolio in the targeted testing of hematologic cancers with the launch of MatBA for Follicular Lymphoma and Mantle Cell categories that are very unmet today using genomic test. So our mature B-cell neoplasm franchise continues to make sure and these are microwaves that are highly accurate and allow clinicians to selecting on treatment options by providing prognostic and risk stratification information. This test also allows the biopharma’s opportunity to recruit monitor patient populations that may have a more likely reaction and will probably understand their genomic profile.

And so if you may have read this morning in our release with three very exciting new programs here at CGI that leverage next generation sequencing, one in kidney cancer and two in hematologic cancers. We expect that HEM panels, lymphoid panel [indiscernible] to launch this summer. We’ve made tremendous progress in the pass quarter, these will be on the alumni system and unlike other first generation approaches ours are focused on actionable, clinically validated genomic content meaning targeted and we also hope to file IP on these panel shortly and continue to build our strong position in the blood-borne and urogenital diagnostic content.

I would also like to note that our work in CGI is distinct from the solid tumor panels being developed by BioServe in next gen sequencing and the approaches are quite complementary. In a few moments I’ll stand on the acquisition after Ed Sitar, our CFO provides with a brief overview of our first quarter results, but to give you highlight we grew year-over-year at 45% in test volume, 17% in revenue and we also continue to expect higher growth as we ramp up our sales team which we built add aggressively toward the end of Q4 and really into January and February of this year.

And more importantly we expect our clinical trial work to be get started more full swing during the second half of this year and we have also bypassed the major impact that the winter months had.

So, now I turn it over to Ed, who will talk a little bit about our Q1 results. Ed?

Edward Sitar

Thank you, Panna. It’s a pleasure to be with everyone this morning. When I spoke the few on our last call, I conveyed my excitement to be joining CGI and up in coming leader in personalized medicine with technology that cannot affect treatment cost but the outcomes and lives of patients. The past 45 days I only could affirm my excitement as we are building unique company that will deliver value to providers, patients and payers.

Now let’s turn to the quarter. All comparisons I’m going to discuss compare the quarter’s ended March 31, 2014 and March 31, 2013. Revenue in the first quarter grew 17% or $212,000 to $1.4 million. This increase was primarily due to an increase in test volume partially offset by a decrease in revenue purchased. Total test volume increased 45% to 2772 tests. Average revenue per test decreased by 18% to $506 per test, primarily due to a higher percentage of direct bill test and the introduction of our unique FHACT test for cervical cancer in our revenue mix.

Direct bill test carry a lower per unit revenue contribution, FHACT will be a larger part of our business as well it continues, however the test price of FHACT is below our historical average test price and thus will impact this statistic in the future.

Revenue from direct bill customers which include hospitals, cancer centers and biopharma companies represent 61% of our total revenues. Direct bill customers are institutions where we have a – we have separate payment arrangements and where a third party payer is typically not involved. Revenue from this group increased 70% or $358,000 to $869,000.

Medicare revenue which account for 17% of our total revenue decreased 3% or $7,000 to $250,000. This was primarily due to a reduction in reimbursement on a laboratory fees schedule. Revenue from insurance carriers and others including DNA prog sales represented 22% of our total revenues and decreased 31%, $139,000 to $311,000.

On a standalone basis, DNA prog sales decreased 36% or $16,000 primarily due to a decrease in volume, certain international tenders were delayed. Gross profit was 9.8% in the first quarter of 2014 compared to 12.2% in the first quarter of 2013. This near term decline was not surprising to us, as we took steps to scale our operation and support revenue growth in future periods.

As volume grows, we should see gross profit margins move up as our increased capacity is better absorbed. Research and development expenses for the first quarter of 2014 increased 22% over the first quarter of 2013 or a $106,000, primarily due to an increase in headcount involving the development and validation of our diagnostic test.

Sales and marketing expenses for the first quarter of 2014 increased 89% over 2013 or $352,000, due to increased headcount as we hire and train in employee additional sales and marketing personal.

General and administrative expenses for the first quarter of 2014 increased 74% or $1.2 million primarily due to an increase in compensation cost of $899,000, 58% of the compensation increase is due to a separation agreement that we entered into with our former CFO in March of 2014. 32% of the compensation increase relates to increases in stock-based compensation which are non-cash.

We also incurred $700,000 of additional cohorts related to being a public company increased insurance cost and increased Delware franchise taxes. These two items accounted for 40% of this increase.

As many of you are aware, our income statement can be materially affected by changes from the valuation of warrants. The first quarter is no different, as valuation resulted in $44,000 of non-cash expense in the first quarter of 2014, compared to non-cash income of $5.3 million in the first quarter of 2013.

When you look at our loss without the warrant valuation effects, which is a non-GAAP measure, our loss in Q1 of 2014 was $2.4 million compared to a loss of $2.9 million in Q1 2013. This is an improvement of approximately 20%. The 2014 loss is consistent with the range, we expected to burn in the first quarter of 2014.

When you include the charges related to warrant valuation, our 2014 first quarter net loss was $2.5 million or a loss of $0.27 per diluted share. This compares to net income of $2.4 million in the first quarter of 2013, our fully diluted loss of $2.18 per share as the non-cash income for warrant valuation is excluded from the fully diluted EPS valuation.

We had total cash and cash equivalents of $47.6 million at March 31, 2014, $41.3 million was unrestricted cash and cash equivalents and $6.3 million was restricted primarily to collateralize our recently renegotiated credit facility. The high level of collateral allows us to access this facility at a very attractive rate, approximately 2%.

As our business grows we will explore opportunities to reduce the level of direct collateral requirements, balancing of course the net volume cost. Once again it’s a pleasure to speak with all of you.

I’ll turn the call back over to Panna.

Panna Sharma

Ed, thank you. I’d like to first highlight a few things, that weren’t covered in our financials. First sales of FHACT, in the first quarter had very solid performance achieving meaningful percentage of our sales volume and almost nearly 10%. And we now have several signs routinely sending, we continue to expand our team directly focused on making FHACT more readily ordered by OBGYN sites and by some of the large labs servicing the women’s health category.

Secondly, we continue to have tremendous growth at our SelectOne program, the program that provides biotech and pharma companies the access to range of genomic and biomarker base testing technologies. And these clients typically are direct bill, they’ve accounted for about little over 55% to 60% of our revenues in the first quarter.

We announced in February that our SelectOne backlog exceeded $13 million that number now is over $14.25 million and continues to grow. These clinical trials are taking time to ramp up, but as enrollment in these trials continues to accelerate and meet the enrollment minimum are recognition of revenue will also start to ramp up. And we are already seeing signs that we’ll see significant acceleration of this in the second half of the year.

We of course had delays in two very targeted trials one of those since Q1 has begun and the other one now has actually good news for us, has actually increased the enrollment and the enrollment is up by 70%. So the size of the trial will also increase.

So let’s continue to talk today, about the announcement acquiring BioServe India which we are renaming Cancer Genetics India. We feel that bringing this brand and to market in India is going to be a very powerful and strategic move for us and our shareholders and it positions us well to become a more diversified and multinational player in cancer genomics and diagnostics.

It also their improvement allows us to be increasingly cost effective, in terms of our ability to compete in this market long-term. Genomic developing, unique genomic content is a key driver of value, but equally as important is developing genomic content in ways that makes the price point accessible by community hospitals, cancer centers and patients globally.

So one of the key pillars of our business strategy has been continued investment in our product offerings in a cost efficient manner and an impact, in ability impact markets were test and services are needed.

This combination of BioServe and Cancer Genetics will make a very positive impact for our shareholders and it helps accelerate the execution of our strategy. We’re very excited about this acquisition, the company’s won the premier genomics and sequencing companies in India with 33 employees including 9 sales and marketing personal, Rama Modali, will be joining our company founded the company. He is a great addition to our management team and will help us get to the integration and management. Rama is a former NIH employee, did his oncology training and fellowship in NIH and he will become a country manager for CG India as well as EVP of Cancer Genetics. We expect to close this in third quarter and we expect 2015 to be accretive.

We acquired the company in terms of detail the transaction for combination of company stock and deferred payment obligation and cash. The cash outlay and that was about $250,000 deferred payment obligation type of value of our transaction of roughly $1.2 million and about $450,000 in stock to closing.

The primary owner besides Rama and his management team is VenturEast, a pioneering healthcare-focused venture capital fund manager based in India that have a decade experience plus a $300 million in our management. VenturEast is very well known successful in these firm in clean-tech, high-tech and biotech, with a lot of success in healthcare mostly, recently with Accel ventures in a home healthcare company Portea.

They are going to make an excellent partner for us and our shareholders as we accelerate our growth in India and hopefully in broader South Asia. Obviously our investors should be very exciting, entering the high growth Indian diagnostics market, because it not only gives us actionable immediately – immediate opportunity to lower our cost of goods by setting our preparations to do genetic analysis in India do bioinformatics and development.

But also very important now to access global clinical trials for oncology that are starting in India and Asia, and as you know this is a high growth market, several of our existing biopharma customers and several of the BioServe customers decided to cross border a multinational trials. And so we think is positioned us very well given our unique content and now multi-site locations.

One of the key strategy is behind the acquisition was to also migrate more the manufacturing of our DNA progs including those used in our proprietary cervical cancer diagnostic product FHACT into India. We will now be over develop that test over time at a lower production cost and give us more flexibility in the market with regards to pricing and also pricing globally not just for the U.S. market.

This provides us a significant advantage long-term advantage in the marketplace and with the substantial differentiator and ability to be more aggressive in pricing and costs. Cost ultimately in any blockbuster product is important and especially for product that’s designed and really impacting cervical cancer, which continues to be the number one killer of women globally.

And all of the matters, we look this is a very powerful and strategic acquisition, it positions us well globally and allows us to be more flexible and cost effective and very important shows us a great blueprint for future acquisitions. We also have plans on bringing BioServe into clear accreditation, they are now currently NABL accredited which is a very important accreditation in India for clinical testing, see equivalent to clear and now we are on plans to leverage and make it fully clear compliant so we can integrate more readily with the U.S. operations as needed and also have one set of common SOPs.

We think this unlocks a great deal of value for CG for CGI shareholders and is very synergistic across multiple aspects of our business. Another important driver is, we really wanted, we won the first labs in India to have NGS up in running and they are already doing so and now we’re going to also now launch with their help two panels in India for cancer hotspot panels that are for solid tumors, it’s very complimentary to our proprietary development and the hematologic and kidney cancers.

They’ve been providing NGS for research and also as a reference lab and so migrating this now towards oncology would be quite around it. We believe we have a very important brand that they can leverage and we can also incorporate our other unique products into their accredited reference lab.

We think that this puts us in a very high growth market, as high quality revenue and has an excellent blueprint and model for additional selective acquisitions that can aid in revenue development capability enhancement and cost improvement.

With that, I’d like to open up the call to any questions. Thank you.

Question-and-Answer Session


Thank you. [Operator Instructions] Our first question is coming from Ben Haynor from Feltl and Company.

Ben Haynor – Feltl and Company

Good morning, gentlemen.

Panna Sharma

Good morning, Ben, how are you?

Ben Haynor – Feltl and Company

Well, thanks for taking the questions. Just on the BioServe acquisition right now is that revenue that they are doing skewed more towards biopharma partnerships or is it more hospital-based where they are seeing the revenue come from, how do you see that evolving over time and if it is with their biopharma, if there is a significant portion of that? What type of backlog might they have?

Edward Sitar

Sure Ben, as you know, we spend some time getting to know the company. They have a good diversified base of revenue; the majority of the revenue as we see they have today is from research services to the research institutions and biopharma customers in India. The clinical business is accelerating quite nicely and rapidly and that’s one of the opportunities for growth and also that’s one of the things that we’ve been talking about with their conductors and with the team is really how our brands together can help accelerate, a very differentiated clinical value proposition in India.

So we expect their pipeline to in broader research in biopharma continue, they have great pipeline, great customer set some very unique relationships with top government institutions, like semi-exclusives and exclusives for sequencing and genotyping. So we will continue, I mean that’s very important revenue, we’ll continue accelerating that as well as we can. But it really is the synergy of bringing together our unique clinical focus with their content and the clinical business that’s growing there. That’s – it’s going to be a nutshell, I think once we start segmenting, one of the first things we’ll do post-closing we start to look out and how to segment the revenues that we can kind of report along some more of these industry type lines.

Ben Haynor – Feltl and Company

Okay, thank you. I’ll jump back in the queue.


Thank you. Our next question comes from Ram Selvaraju from Aegis Capital.

Ram Selvaraju – Aegis Capital

Thanks very much for taking my question. Could you comment on the workflow of sample processing at BioServe, whether there is going to be processing of sample solely coming from the Indian and surrounding region or whether you would potentially be rather examples from the U.S. over there? And also could you comment on two financially related items, firstly stock-based compensation expense in the first quarter and how you expect that to trend over coming quarters? And secondly the question of income tax benefit and how you anticipate that revolving over the subsequent quarters going forward? Thank you.

Panna Sharma

Ram great, good questions. I’m going to go ahead and take the first one on samples and Ed will – items our CFO on the stock-based comp and the income tax benefits, I think it’s a good for housekeeping in general. So, let me take the first question, and if you – and then I just get to prepare specific items on stock comp and the income base, we’ll also reference the pages in the queue as well that you can look them up on.

So first question for everyone is sample, sample flow to make it clear we will not be sending samples from the U.S. to India that’s not part of our strategy, that’s not part of workflow and that is not also compliant and do a lot of issues. They have their own samples and workflow in India that they are doing quite nicely, it is a Brownfield opportunity they are already in market. But we do expect to use their infrastructure for the genomic analysis of the content as we put it up into a HIPAA-compliant cloud, that could be used both for trials, it could also be used for having multiple sites provide concordant data.

But also very importantly as many of you know the biopharma industry is increasingly spending money on doing trials throughout India, South Asia and China. And so we do expect since we’re centrally located in a high-tech city of Hyderabad that will be a great site to actually accelerate the development of a joint SelectOne business for the South Asian market.

Many of our pharma customers already are doing trials in India or China or both or in South Asia so this positions us very well to service them better by having a site in Hyderabad. They already have samples now most of them coming obviously from Central and Southern India, the career infrastructure there is developing, but they do get samples and they will continue getting samples from not only India, but also potentially now from broader South Asia. So we think its great position to accelerate our SelectOne business. But samples will not be going from the U.S. to India, only data and only data analysis and bioinformatics and of course that will be done in a compliant manner.

So, I’ll turn it over to Ed. Ed?

Edward Sitar

So your two questions, I’m going to take the tax question first, in the first quarter we have recognized the tax benefits from the sale of our state NOLs that’s a program unique to New Jersey, we will apply avail ourselves in that program for next year. So for the remaining quarters of the year, there should be no tax benefit on the tax line.

Ram Selvaraju – Aegis Capital

It’s only one year.

Edward Sitar

Once a year in the first quarter and the reason we recognize that when we received the cash is because is dependent on the amount of – amount is allocated for the program which affects the state budget. So we don’t know what we really get until we actually get it is the way I put it. In terms of the stock-based compensation, I’ll need to get back to you Ram on that. Our stock-based compensation will be higher in 2014 than it was in 2013, but we do have a couple of license in there that were one timers relate to the departure of well with our Board members. So if I could – if you could indulge me, let me get back to on that well.

Ram Selvaraju – Aegis Capital

The change in Board members.

Edward Sitar

Change in Board members.

Panna Sharma

The change Dr. Andrew Pecora to Dr. Paul Rothman.

Ram Selvaraju – Aegis Capital

Okay, thank you very much.


Thank you. Our next question comes from Sung Ji Nam from Cantor.

Sung Ji Nam – Cantor

Hi, thanks for taking my question. I was wondering if you could maybe give us more color on FHACT this quarter, in terms of how the customers are using that and it sounds like you’re getting a good update there. I was wondering if your customers are kind of trying this out in a trial basis or few adoptions pretty much across the board for their respective laboratory. And then also could comment – if you could comment on the why the decrease in ASP and if you expect that trend to continue or, over time would that trend be reversed?

Panna Sharma

Good question Sung Ji, thank you. I’m going to parse them, let me take the ASP question first then we’ll go back to FHACT is that okay. So on ASP as you saw price are, we had a very significant increase in our direct sales, direct bill clients. These include can make some times to really hospitals, large cancer centers and of course biopharma. We’ve built out our sales team, starting in late Q4 and Q1 with our spend, the ex-program we are seeing increasing volume from hospitals. And then typically what we see in same as order pattern that we start that I experienced here, as they typically start with, some of the lower price test, before they start getting into our complete offering that’s one thing that’s affected it.

The second is FHACT sales, which is I mentioned are about $100 to $125 lower than our typical average price that we recognize. And so we expect that will have an effect, but obviously the market for the FHACT is very significant. So, you think that our ASP will fluctuate kind of in between what we are seeing this quarter and we’re seeing in historical quarters. And a lot of that also will depend and some of the studies that we are coming out, we have a number of studies for the kidney cancer array and for the MatBA Follicular and DLBCL were really pushing for higher and more unique pricing on those test.

And as the most test like other, the kind of the billion dollar genomic companies they require multiple studies and multiple evidence points to support higher reimbursement. So I think we’re very conservative on reimbursement that we have a number of appeals and payer projects that are going on right now, on track its earlier part of this week a big time we spent on this payer projects. And so, we don’t – right now we don’t know expect much from those, but, they are going very well and they can actually impact our average revenue per test quite considerably.

In terms of the FHACT turning over to more in FHACT, we have a combination of sites that we’re trying it out, as well as sites that are beginning to routinely send. So that we have mix and I expect that mix to probably, continue to be people who are trying out and people who are routinely sending. We are finding that it typically takes about two months, one to two months or people to become comfortable depending on the volume that they have. Of course we have customers that are sending dozens a week and customers are all sending a couple of week and potentially few customers that could be sending 100s a month.

So we have customers kind of all along the map and really is typically what we are seeing is about a month to kind of get all the issues ironed out second month really comfortable reporting and integrating into routine care. And with the DNA progs as many of you know there is already an accepted market, that some accepted reimbursement. And people understand these markers have been clinically known to be involved with some of the cervical cancers. So there is, we’re seeing is typically we see a lot of headnoding and a lot of understanding how to quickly use it. And the most compelling value point of course is that there is no requirement to border the OBGYN and the patient, because we reflex directly from a HPV positive or abnormal PAP cytologically and bill directly to this test. So the convenience to the test is a huge factor for these for these sites that are ordering.

Sung Ji Nam – Cantor

Thank you, I’ll get back in the queue.

Panna Sharma

Thank you.


Thank you. [Operator Instructions] Our next question comes from Thomas Pfister from RedChip.

Thomas Pfister – RedChip

Hi guys, thanks for taking my question today. My question relates to your next generation sequencing panel. So during the call you referenced that these panels are different from some of the other product down the market, in particularly that they are targeted, do you could give us more color on the advantages that your panels have and how does these panels, how are they attractive to both doctors and potential biopharma client?

Panna Sharma

Thomas, thanks good question. I think there is, we’ll continue to add in a lot of dialogue in the industry about these pan genomic panels and targeted panels. I say personally there is a role for both its not an either or proposition, it really depends on the diagnostic audacity that the patient is involved in and really how quickly the targeted therapeutic agents come along.

And as you know in every cancer it’s quite different, we have a renaissance of targeted therapeutic agents coming along in the blood borne cancers beginning, little bit earlier and urogenitals could just mean a variant, it’s really the value of targeted content, and that’s the key kind of to our value proposition is that number one it’s easier to clinically validate, which is very important. It’s easier for researchers and clinicians to understand the impact of the algorithm or the interpretation across 18 sites or 80 genomic sites that post to 800.

And more importantly, we are not leaving ourselves open conjuncture, namely meaning that if you have a genomic site that is mutated that’s very relevant in one type of cancer, it may or may not be as relevant or as involved in different cancer. And lot of these things may prove to be true or may prove to be unknown. So, we think having targeted content it’s in the interpretation makes more rapid the ability to have clinically actionable content. And very importantly this is important for, the target content requires us to cure rate and interpret and create algorithms. All that work has in our experience is patentable. Just reporting on 100s of 1000s genes is not a patentable event or method as we understand it.

So long-term we think having targeted content that’s unique is a patentable opportunity for us and it gives us a differentiator, and as you know it also allows us to have superior cogs, because there is a number of regions and amount used as you know and doing everything from the sample prep to the extraction to the library creation doing it for 100s of 1000s of genes versus doing it for targeted set is a meaningful impact in your cogs. So we can run multiple samples in multiplex and we can go deeper also. So if we have certain sites that we want to deep sequencing or we think if they are more involved that they aren’t covered with the widespread panel it gives us a flexibility.

So again that, I don’t want this to be a binary session of one approach versus the other approach, I do think both approaches as a meaningful place in the evolution of NGS and how it plays out clinically. So, I think they both work together and there shall be room for both depending on again where the diagnostic issue audacity is from the patient.

Thomas Pfister – RedChip

Okay, great. Thank you so much for the color there Panna and again congratulations on the BioServe acquisition and I will hop back into the queue.

Panna Sharma

Thank you.


Thank you. Our next question is a follow from Ben Haynor from Feltl and Company.

Ben Haynor – Feltl and Company

Thanks for taking the questions. Just a kind of another one on the impact that weather may have had for you guys been you’re located in the Northeast. Can you maybe quantify how many days that you might have lost during the quarter due to weather? And then also is there a number that you’d quantify as to what happened with the kind of the timing of biopharma payments or the start of trials that may have impacted the quarter as well?

Panna Sharma

Sure. These are obviously some of the issues we faced in the quarter. When you are in Minneapolis you see probably are not as sensitive to [indiscernible] we are probably in New Jersey. But, we had quite a few storms this winter. I think we actually had more snow than Minnesota. But, we had about we estimate 10 to 12 work days that were impacted. And our calculation is about 98 work days in Q1, we count Saturday as a work day, Sunday we do not. But we had 98 work days that were available to us roughly and six of them were cancelled all together. Another four to six were delayed, because typically before the big storms, things shutdown. And then after the big storm things were delayed or delayed in opening up either we couldn’t get people under lab, we couldn’t get samples to local airports like Peterborough, New York, LaGuardia were closed or shutdown or delayed. So, samples coming in were challenging.

So, it was a big impact, I mean obviously we don’t want to use that as a huge crush going forward, but those are real days lost in terms of not only productivity, but also in terms of patients visiting their doctors and samples coming in. So, we estimated by 98 days, we were impacted very directly on about six of them and then indirectly on another six as a result of delays and lost productivity.

Let me now talk on the other topic, which was on the clinical trials as many of you know our clinical trial contracts through SelectOne really increased quite by heavily last year and going into this year. We signed several multi-million dollar type trials. So, the challenging part of some these trials is getting the enrollments going. And so to the trials that we’re expecting to really kick-off are slightly delayed and one of them it just, they start picking up now in Q2.

The other one was pushed out largely pushed out, because of design, they decided to increase the enrollment significantly by about almost double, and as it went up almost an 80%, 70% to 80% increase in the patients. So, it’s actually a positive for us long-term because the testing we’ll be doing is going to be significantly higher. And that will obviously add to our SelectOne pipeline going forward. We don’t give direct numbers on it but in the quarter several hundred thousand per month that were impacted in the quarter.

Going back to an earlier question, I want to make sure we tackle this, the most stock-based comp. So, Ed, I will turn that back over to you to close that.

Edward Sitar

Okay. So, on the stock-based compensation, in the quarter, we had about $530,000 of stock-based compensation. If you’re thinking about that on a go-forward basis, $230,000 of that was one-time, so $300,000 per quarter going forward.

Ben Haynor – Feltl and Company

In a month?

Edward Sitar

In a month.

Ben Haynor – Feltl and Company

And then, if I could just ask one more quick follow-up that would be great.

Panna Sharma

Yes, go ahead Ben.

Ben Haynor – Feltl and Company

Okay, thanks. I wasn’t so – so just given the impact that the timing of those trials starting and obviously direct bill revenue that would have come from that. I guess with the 70% increase that you saw on the direct bill business, would it be safe to assume that that’s a reflection of the sales for hires that you made late last year and early this year becoming productive in several new hospitals and cancer centers or is it something else?

Panna Sharma

Good question. It’s a mix, it’s a both terms, SelectOne, and we saw an increase simply, because we’ve seen increase over the past year historically. So, over Q1 of last year that continues to grow not at the kind of more extreme kind of rate that we’re expecting. But, we think we’ll definitely get there. But, the impact was also several new hospital sites and cancer centers beginning to send. And so that those volumes will pick up as they go from trial sites to broader indications to routine customers. So, I think we see both things clicking, that’s why we had the big increase in the direct bill.

Another thing to point out as an emerging growth company, we try to really focus on de-risking our revenue. And so many cases, we actually push for direct bill, because we know that the ability for us to collect is going to be a lot easier versus checking on additional third-party reimbursement. And some of those decisions were made prior to Ed, joining us here in April. Obviously Ed has got great background, his background with Aetna and Healthagen payers it is going to be essential to us building a world-class reimbursement team here. But, we made some of those decisions earlier to go direct with certain accounts to avoid taking on behind those reimbursement, we might revisit those. And, obviously going from direct reimbursement in some of those sites to us taking on the risk has the big opportunity to increase the average revenue per test. It’s a good question Ben.

Ben Haynor – Feltl and Company

Great. That’s sounds very helpful. Thanks for taking the questions.


Thank you. Our next question comes from Brooks O’Neil from Dougherty & Company.

Brooks O’Neil – Dougherty & Company

Good morning guys. I’m just curious I might have missed a few.

Panna Sharma

Good morning, Brooks. How are you?

Brooks O’Neil – Dougherty & Company

I’m fine Panna. Did you give us any update on the Mayo joint venture, what’s happening with that?

Panna Sharma

Good question, Brooks. We have a major milestone meeting in the third week of June in Rochester just here last month as well. So, we have monthly updates and reviews in all three projects. I’m quite continued to be very excited by these proprietary panels that we’re developing and along multiple myeloma and follicular. We’ll be hosting an Analyst Day, date is yet to be determined, but it will be late June, perhaps the first week of July, where we’ll be providing a full update both on our OncoSpire activity as well as the CGI activity in terms of our portfolio. And, by then, we might may have actions are closed in third quarter the – the BioServe.

So, we’ll have an Analyst Day, where we go through, the entire portfolio and all the programs and detail and but, we continue to make progress, we as you know we made a million payment to Mayo and we’ll be expecting an ex-million dollar payment to be made to Mayo in probably in the third quarter as well to continue the programs. But the programs are developing, we get routine updates, we’re very involved in Rochester. And we’re – we think the real potential, one of these programs out even probably in the next less than three quarters. So, we’ll be – it’s progressing quite rapidly.

Brooks O’Neil – Dougherty & Company

Great. Thank you very much.


Thank you. Our next question is a follow-up from Sung Ji Nam from Cantor.

Sung Ji Nam – Cantor

Hi, thanks for taking my follow-up. I was wondering just another question on BioServe, I recognizing that, this is a rapidly growing market in India, et cetera. I was wondering if you could kind of maybe talk about how BioServe fits in the – that market, in the Indian marketplace, in terms of are there a lot of companies like this out there? And also if you could maybe talk about and I think I missed it in your prepared remarks, what kind of revenue they generated in maybe 2013 if you feel comfortable talking about what that could be in 2015? And, if you could talk about the competitive landscape in India, that would be very helpful?.

Panna Sharma

Good. Thank you Sung Ji, these are good questions. Obviously with limited time, I won’t go into whole landscape discussion. But, we looked very closely. We have been looking at India, since we started looking at the production of our probs using as a cost center. But, as we got more familiar with the market and talked more with companies and venture capital and private equity, it became clear that the national the local market, India was also beginning to grow at a rate that we were quite surprised by I mean the analyst will predict between I believe 15% and 20% growth on the clinical side, the diagnostics for the next decade and it’s just a unprecedented amount.

And we had several visits there. And, we’re literally seeing in front of our eyes. There are only a handful that – of companies that we look at, that had the, I would say the quality and focus especially around the types of capabilities that we wanted. And we talked to most of them cultural fit is important, ability to execute deal is important, long-term additional alignment. And all those things really matter. Bio was not the smallest company, was not the largest company but it was the right company, because of their capabilities and their desire to really make a meaningful impact in oncology. So, in terms of its focus on oncology, and what they were doing with NGS, it’s probably only like three or four companies max.

It is far along and versus the other players there. And the cultural alignment was very good. In terms of market, we’re seeing is that the Indian market and I think we probably have an FAQ somewhere around this. It is sizeable, but everyone wants to talk about India is being doing people. But it is several different markets you’ll notice a billion plus people. We estimate and also I think most analysts estimate that there a between a 100 million and maybe 133 million people that are very kind of the very gentrified. We have significant disposable income; high purchasing power parity and access to private health insurance were combination for all of those that can really afford kind of the genomic and biomarker-based test that have a superior spend on healthcare. And that’s the market, we think is immediately accessible.

At the same time, we do think that FHACT is a huge opportunity. And as you know, one of our early partners [indiscernible] is routinely using that. We expect many other hospitals to join in. And so, if we want to really make that into a blockbuster in India, it’s important that we bring the cost down for that product. So, as we look at what should we do, we want access to this market seems meaningful, seems like we’re well put to play. And at the same time, we have a blockbuster potentially here, because FHACT and its potentially used. It became clear that we needed a partner that could help us accomplish both goals. And so, when we’re looking at from that standpoint and then continuing to use the lines of cultural alignment, it was clear that this is the company that made the most sense. So, we got another company very well, we think it’s the right fit, and we have to close transaction in the third quarter. And I think it’s very unique proposition in terms for our shareholders, but also for future growth.

Sung Ji Nam – Cantor

Okay. If I could – could I squeeze in one more question on your kidney test. I was wondering in terms of your current partners, Memorial Sloan-Kettering and I believe Cleveland Clinic. Are they, in terms of, I know you’re obviously conducting clinical trial more clinical that even et cetera with that product. I was wondering with the current collaborators, if you’re seeing increased volume and as far as utilization of the test from them?

Panna Sharma

It tends to be sporadic, I think like most accounts we got to stay in front of them, but they’re very interested in helping us sending samples here both for study as well as for clinical utilities. So, we get samples from both sites. The bigger excitement for us is we are in now discussions with several other sites purely for just clinical utility not wrapping up into a study. But, obviously since both Sloan-Kettering and Cleveland Clinic were early validators joint publication providers as part of the validation of the panel. And we actually have some ongoing and we’ll be putting out some data on other additional study as I mentioned for kidney cancer. I think we’ve indicated that we’re doing a study now that is mature and more embedded perspective and other one that’s looking at developing a potential signature for sutent response. So that’s – we use the metastatic cancer. So, we continue to do these studies, I think kidney is a major franchise as I mentioned is 60,000 new cases, we have estimate there to be 250,000, 300,000 in the US at any given time.

And there is a real need for genomic content especially given all some of the new drugs that are coming out with combination protocols. So, yes both sides, we continue to develop more content. We are getting routine specimens from those sites, but also from other sites that are purely just for clinical, just for clinical use only.

Sung Ji Nam – Cantor

Great. Thank you.


Thank you. That’s all the time, we have for today’s call. I would now hand the call back over to Panna.

Panna Sharma

Thank you. I think we had a lot of really good questions. I want to thank Ed for a wonderful job he’s been doing. And of course, for our shareholders it’s an exciting time to be involved with the company, but more importantly we think that this transaction and the foundation that we continue to build position us really well to be one of the premier leaders in the genomically driven diagnosis of cancer and a personalizing treatment. So, thank you all for listening in and continuing to support CGI. Thank you.


Thank you. This does conclude today’s teleconference. You may disconnect your lines at this time. Thank you for your participation.

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