Biocept, Inc. (BIOC) CEO Michael Nall on Q4 2018 Results - Earnings Call Transcript

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About: Biocept, Inc. (BIOC)
by: SA Transcripts
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Earning Call Audio

Biocept, Inc. (NASDAQ:BIOC) Q4 2018 Results Earnings Conference Call March 28, 2019 4:30 PM ET

Company Participants

Jody Cain - LHA, IR

Michael Nall - President and CEO

Tim Kennedy - SVP, Operations and CFO

Edwin Hendrick - SVP and CCO

Conference Call Participants

Jason McCarthy - Maxim Group

Operator

Ladies and gentlemen, thank you for standing by, and welcome to the Biocept Fourth Quarter 2018 Financial Results Conference Call. [Operator Instructions] As a reminder, this conference call is being recorded today, March 28, 2019.

And at this time, I like to turn the conference call over to Ms. Jody Cain. Please go ahead, ma'am.

Jody Cain

This is Jody Cain with LHA. Thank you for participating in today's fourth quarter conference call for Biocept. Joining me from Biocept are Michael Nall, President and Chief Executive Officer; Tim Kennedy, Senior Vice President of Operations and Chief Financial Officer; and Edwin Hendrick, Senior Vice President and Chief Commercial Officer.

During this call, management will be making a number of forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements include all statements that are not historical facts and generally can be identified by terms such as anticipate, expect, believes, could, expects, intends, may, plans, potential, predict, project, should, will, would, or the negative of those terms. Forward-looking statements involve known and unknown risk, uncertainties and other factors that may cause actual results, performance or achievements to be materially different from those statements, as well as performance or achievements that are expressed or implied by the forward-looking statements. For details about these risks, please see the company’s SEC Filings.

The content of this call contains time sensitive information that is accurate only as of today, March 28, 2019, except as required by law, Biocept disclaims any obligation to publicly update or revise any information to reflect events or circumstances that occurred after this call.

Now, I’d like to turn the call over to Michael Nall. Mike?

Michael Nall

Thank you, Jody, and good afternoon to everyone on the call today.

The significant steps to restructure our commercial organization are beginning to gain traction and our test volumes are growing. I'm pleased to report 938 billable samples achieved in the fourth quarter of 2018 up 7% from the third quarter which we believe is the start of the growth trend. Given the strong momentum that we are seeing in the first quarter of this year, we expect that our efforts to refocus our commercial strategy are paying off.

A key driver of this growth is an emphasis on our pathology partnership service which leverages our unique target selector circulating tumor cell or CTC platform. We recently announced the expansion of this service with the capability to analyze additional prognostic and predictive markers for solid tumors including prostate cancer. With these new markers we are increasing our focus on the euro oncology market which we announced earlier this week.

Our pathology partnership offering called Empower TC enable's pathologist to interpret the results of our proprietary CTC testing thereby ensuring that local hospital laboratories and pathologist remain in the critical path of the patient care continuum. We believe that Biocept remains the only commercial liquid biopsy company offering both CTC and circulating tumor DNA or ctDNA analysis from the same blood sample and this differentiation is helping us gain market adoption.

We continue to make progress in broadening our planned transition of Biocept into a comprehensive diagnostic solutions provider, offering laboratory services and molecular assay kits with a global brand. Earlier this year, we announced the availability of our research use only kits intended to enable molecular laboratories around the world to utilize our target selector ctDNA assays to perform liquid biopsy testing. We also announced our first customer for these kits Agiomix, a provider of genomics and bioinformatics services in the Middle East Africa and Asia for both research and clinical applications.

Our target selector platform is a patent protected in the United States and in 10 major international territories. And our first available kit is for the high-sensitivity detection of EGFR oncogene mutations which are among the most frequently evaluated biomarkers for lung cancer.

Additionally RUO test kits for other oncogene mutations are planned for launch in the future. This new product line will allow us to expand our liquid biopsy business geographically by selling these kits to laboratories around the world which can use them to develop and conduct their own laboratory test utilizing our proprietary cutting-edge liquid biopsy technology.

To continue to fuel our commercial progress, as well as other corporate development activities, we recently raised $8.2 million in gross proceeds and when added to funds raised since the first of the year currently gives us approximately $15 million in cash on our balance sheet. We believe that our strength in balance sheet positions us to achieve important milestone this year as we strive to create shareholder value.

For 2019, we have several key initiatives that we are focused on to advance our business beginning with our partnership with Prognos. This project is moving along with the IT infrastructure to facilitate this collaboration and is expected to be completed in the second quarter. We remain excited about this partnership with the goal of commercializing the identified information we generate from the test we perform in our own laboratory.

As you may recall, Prognos continues to add to its repository over 20 billion laboratory records to apply artificial intelligence or AI to clinical laboratory diagnostics in order to help life science and pharmaceutical companies to develop and market targeted therapeutics that can improve personalized medicine protocol.

Also advancing is our quality improvement initiative collaboration with Highmark Blue Cross and its subsidiary Allegheny Health. You may recall that Allegheny is one of the largest integrated healthcare delivery systems in Pennsylvania and a key goal of this initiative is to increase the rate of testing from molecular biomarkers in advanced lung cancer patients to 100%.

According to Allegheny between 2011 and 2013, less than 60% of lung cancer patients at a large tertiary care hospitals were tested for molecular biomarkers such as EGFR ALK and KRAS 1.This challenge exists primarily because with many lung cancer patients there is insufficient material from a tissue biopsy to perform molecular biomarker analysis. With our liquid biopsy technology, we believe that testing 100% of advance lung cancer patients is achievable due to the convenience and reliability of using a simple blood sample for testing.

Oncologists in the Allegheny network are very interested in this approach and I'm happy to provide an update that the study now has accrued 25 of the 100 patient's plan for the program. So far the early results indicate that our liquid biopsy testing has identified actionable biomarkers in some of the patient's tested, and importantly several patients have responded to treatment driven by the information that our testing provided.

Missing actionable biomarkers in advanced lung cancer patients with tissue biopsy alone not only limits treatment options, but also can be costly. Testing with our liquid biopsy assays can help avoid the need to perform a secondary biopsy which can be invasive, expensive and risky. The quality improvement initiative with Allegheny Health is designed to evaluate the clinical utility of our target selector testing, as well as the economic value of our liquid biopsy solution for profiling and monitoring actionable biomarkers in lung cancer patient.

Given the strong enrollment in the program so far we are scheduled to present interim data at the National Blue Cross convention at the end of April. As we advance towards completion of the programs 100-patient enrollment goal, clinical results from this initiative could be reported in a larger form later this year and in early 2020.

Turning to our collaboration with Thermo Fisher Scientific. This relationship gives us access to Thermo’s next-generation sequencing products and supports our plan to commercialize a molecular oncology multi-gene panel. Once validated this partnership will enable us to team up with Thermo Fisher to market molecular diagnostic products and services to pharmaceutical companies, physicians and academic medical centers.

Importantly, once we make this panel available in our laboratory, Biocept will become the only liquid biopsy company offering both individual cancer biomarker tests with the option of a larger test panel. We've been working hard with our partners Thermo Fisher and today we’re pleased to announce that we're completing our clear validation and plan to launch our molecular lung panel in the coming weeks.

As discussed on previous calls, we've been focused on improving our laboratory workflows and adopting automation, utilizing cutting-edge robotic technology for companies such as [Kyjen and Hamilton]. After hiring new heads of quality and regulatory as well as laboratory operations, we believe that we are on track with our efforts to build a business that can scale more efficiently and effectively.

Finally, we continue to broaden our IP position announcing 10 new patent issuances throughout 2018 and one patent granted so far this year. These include patents for our proprietary microchannel and antibody cocktail platform for rare cell capture including CTCs, as well as patents for our highly sensitive molecular enrichment platform. Presently, we have 32 patent issued for our proprietary technologies globally.

To summarize, our corporate priorities in 2019 include the following increasing target selectors market penetration in the emerging liquid biopsy field, signing additional pathology partnership agreements with hospital systems, pathology and other physician practices. monetizing the identified data from our testing results through our collaboration with Prognos, continuing to pursue our quality improvement initiative with Highmark Blue Cross and the Allegheny Health system.

Advancing our collaboration with Thermo Fisher Scientific further automating our laboratory processes to improve reproducibility, quality, productivity and improve margins, advancing our kit and distributed product strategy by entering into additional global distribution agreement, signing new third-party health plan contracts and agreements with integrated healthcare delivery networks, launching additional oncology biomarker assays and publishing additional clinical case studies that validate the use of our target selector assays.

Now I’ll turn the call over to Tim Kennedy to review our financial results for the fourth quarter and the full-year 2018.

Tim Kennedy

Thanks Mike and good afternoon everyone.

For Q4, 2018 we reported revenue of 860,000 compared to Q3 2018 of 762,000 up 13% in sequential quarters while down from Q4, 2017 of 995,000. As Mike mentioned with the changes we've made in the commercial organization, we believe that we are now back on a growth trajectory. Commercial reimbursement based on historical mix and test per accession received is expected to continue to be in the $1,100 range on average as we continue to launch new assays in the coming months.

In Q4, 2018 we had 938 billable accessions versus 878 billable accessions in Q3 2018 and 982 billable accessions in Q4 2017. The number of billable samples per sale day averaged approximately 15 in the fourth quarter of 2018. Our new commercial team is refocusing our marketing and sales efforts on physician, specialties and market segments that we believe are beginning to turn around our volume trends. As a result, we anticipate that sample growth will continue in the coming quarters.

Turning to our cash usage, we announced in Q1 of this year an initiative to reduce our use of cash on an annualized basis excluding the costs incurred in Q4 associated with a clear validation of the Thermo Fisher molecular oncology multi-gene panel. We have reduced all other cash usage by approximately 1.2 million on an annualized basis compared to the cash usage baseline in Q1 of this year when the cost reduction plan began.

While research and development is flat versus the fourth quarter of 2018, general and administrative and sales and marketing costs are both down from the Q1 2018 baseline. On a year-over-year basis cost of revenue for Q4, 2018 was 2.4 million which was relatively flat compared to the same period last year.

Cost of revenue in the 2018 period as mentioned was impacted by an increase in expenses associated with validating the Thermo Fisher molecular oncology multi-gene panel and an increase in costs associated with clear validations to improve upon existing equipment, specifications and automated testing protocol. In addition, we continue to provide laboratory capacity to accommodate higher volumes as we work to improve our growth trend.

Research and development expenses for Q4, 2018 were 1.3 million compared to 909,000 in Q4, 2017. The year-over-year increase was mainly due to a higher proportion of allocated laboratory costs associated with research and evaluation cases received and costs associated with the development of new individual assays and automation as well as Thermo Fisher molecular oncology multigene panel.

General and administrative expenses for Q4, 2018 were 1.6 million versus 1.7 million for the same period last year and sales and marketing expense for Q4, 2018 was 1.4 million down from the 1.6 million reported in Q4, 2017 as the company worked to contain expenses in 2018.

The net loss for the fourth quarter of 2018 was 6 million or $1.43 per share on 4.2 million weighted average shares outstanding. This compares with a net loss for the fourth quarter of 2017 of 5.7 million or $5.36 per share on 1.1 million weighted average shares outstanding. As a reminder, we conducted a one for 30 reverse stock split of our outstanding common stock which was effective in July 2018.

Now turning to our results for the 12 months ended December 31, 2018. Recall that on March 31st, 2017 we converted from cash-based revenue recognition of our commercial revenues to accrual-based revenue recognition.

Revenue for 2018 was 3.2 million all revenue in 2018 was recognized on an accrual basis whereas of the 5.1 million in revenue recognized in 2017 3.8 million related to revenues recognized on an accrual basis and 1.2 million related to revenues recognized upon the receipt of cash.

Billable samples reported in 2018 were 3,896 compared with 4,517 for the prior year. Cost of revenue for 2018 was 10.1 million, research and development expenses were 4.5 million, general and administrative expenses were 7.1 million and sales and marketing expenses were 5.9 million.

The net loss for common shareholders for 2018 was 25.2 million or $9.01 per share with about 2.8 million weighted average shares outstanding. This compares to a net loss for 2017 of 21.6 million or $23.58 per share with about 917,000 weighted average shares outstanding.

In addition to the cash usage reduction I mentioned previously in the third quarter of 2018 we made a payment to Oxford Finance of approximately $500,000 which included our final debt installment and other fees to extinguish our long-term debt facility. With no long-term debt on the balance sheet we have eliminated an additional 2.1 million in annual cash usage. This complements the steps we've taken to reduce our other cash usage throughout the year.

We also anticipate realizing additional reduction in the use of cash in the near future from outsourcing our microfluidic channel manufacturing to a contract manufacturer. In addition, our current facility lease will expire in July 2020 and we anticipate that we will be able to further realize expense reduction by obtaining a replacement facility lease with more favorable term.

Cash and cash equivalents totaled approximately 3.4 million as of December 31st, 2018 compared to 2.1 million as of December 31st, 2017. We raised approximately 25.7 million in aggregate net proceeds from refinancings in 2018 and we raised approximately 17.1 million in aggregate net proceeds from refinancings the date in 2019 bringing our current cash balance to approximately 15 million.

I'll now turn the call over to Edwin Hendrick for an overview of the progress we're making with our commercial effort including the new growth we are seeing in test volumes. Edwin?

Edwin Hendrick

Thanks Tim, and hello everyone.

I'm pleased to share with you that we've made good progress through the end of last year and in the first few months of 2019 our efforts appear to be gaining momentum. Last year, we made the decision to refocus our commercial strategy on certain market segments for our technology platform offers unique competitive advantages and provide clinical value physicians who are treating patients diagnosed with cancer.

We remain very active in the broader market for biomarker testing in solid tumors particularly lung cancer where the clinical treatment guidelines call for the use of liquid biopsy as an adjunct to tissue biopsy as well as in situations where tissue biopsy is not feasible or has failed to identify actionable biomarkers in certain patient.

As Mike indicated, we’re looking forward to launching the Thermo Fisher Akamai panel and further expanding our market share in the lung cancer treatment market. In addition, our commercial team is now focusing on three market segment in which we are gaining traction due to the unique circulating tumor cell or CTC-based offering.

I want to emphasize that our target selector CTC and Empower TC offerings not only enable to capture and enumeration of CTCs, but they also enabled the analysis of biomarkers in CTC which distinguishes Biocept in the marketplace.

The first segment that I want to highlight is uro-oncology market for prostate cancer and our focus in this area with our Empower TC platform. Empower TC enables local urology practices and uropathologists to utilize our cutting-edge technology and to interpret the results of circulating tumor cells and biomarker testing themselves. As we process these tests in our laboratory in San Diego.

As you may have seen earlier this week, we announced the launch of our expanded Empower TC offering which now includes CTC enumeration and testing for prognostic and predictive biomarkers in prostate cancer such as AR, PTEN, C-met and AR-V7. Many men are diagnosed with low-grade prostate cancer and simply undergo watchful waiting or active surveillance to see if there cancer is advancing at increased rate.

Our vision which is driven by the input from some of our physician customers is that our Empower TC platform can be used to monitor patients in the watchful waiting phase with biomarker testing every six months when patients are typically scheduled to go back for their active surveillance exam.

Next we’re focusing our sales professionals on the breast-cancer testing market. Several types of breast cancers have good treatment options and surgery may resolve the disease for many women. However, there are several indications in breast-cancer where there remains a major unmet medical need. Here we believe that our liquid biopsy testing can play an important role in providing new information that can aid in treatment selection.

There is growing interest in the detection and monitoring of CTCs and it relates to breast cancer treatment. The number of medical papers and publications for CTCs has tripled since the year 2000 with over 1,500 publications in 2017 alone. We recently attended the 36th Annual Miami Breast-Cancer Conference and found significant physician interest in our target selector platform for monitoring of CTCs in the blood of breast cancer patient.

Doctors are highly interested in using circulating tumor cells to assess the potential for metastatic disease in breast-cancer. Additionally, triple negative breast cancer are breast-cancer that is negative for the three major biomarkers of HER2 PR and ER over expression remains a major unmet medical need with limited treatment options.

These biomarkers when positive can offer targeted drug therapies instead of radiation and chemotherapy. Our noninvasive testing allows physicians to monitor for these biomarkers over time to determine if there's any changes which can lead to more treatment options for these patients.

Notably in the last two years, we processed over 3,000 of these patients diagnosed with breast cancer and were analyzing this data currently with the purpose of developing white papers and potential publications for the medical community. This data can be quite valuable as evidence for our collaboration with Prognos and are expected contributions to their AI database.

In the future, we hope to use the data from these 3,000 plus tests to develop more information with regards to the clinical utility of our platform and to increase our penetration of the breast-cancer testing market.

Lastly, I want to mention the naturopathic medicine market in which over 5,000 naturopathic physicians are currently practicing in the United States many affiliated with major medical centers. Naturopathic doctors or NDs are trained in integrative cancer care and can be play a key role in support of cancer patients for diagnosis through survivorship. When I came to Biocept, I noticed a good percent of these test volumes were coming from the ND community and now we dedicated our call program to develop this market and drive testing volume with proprietary platform.

Importantly NDs are early adopters when it comes to monitoring a patient's disease using CTCs or ctDNA and we and many experts believe that patient monitoring is where the real promise lies for liquid biopsy. We’re excited for these new market segments and we believe we’ll be able to continue to drive growth of our test volumes through these commercial initiatives.

Since I joined Biocept, we recruited several season sales professional and I'm pleased that our productivity per sales rep has improved. We believe that we now have the right team in place and we plan to grow our current team of eight professional to between 8 to 11 over the next several months. Further expansion from there will be determined later in the year based upon the opportunities we see for growth.

To reiterate what truly differentiate Biocept is our ability to run CTCs and ctDNA on the same specimen. With that in mind, we will be focused on the following market lung, especially with our partnership with Thermo Fisher molecular oncology multigene panel and the new market segments that I just discussed urology, breast-cancer and naturopathic medicine.

Thank you for your time and attention and I'll turn the call back over to Mike.

Michael Nall

Thank you, Edwin.

We have proven the ability of our target selector technology to improve care for many patients diagnosed with cancer. We’re an innovator in the field at a time when diagnostics are gaining recognition for the improvements our industry is bringing to the healthcare system. We have seen this in the liquid biopsy guidelines for lung cancer patients issued by major industry associations as well as the improved reimbursement and coverage for next generation and other cutting-edge testing and technologies.

Our liquid biopsy tests have been performed on nearly 20,000 patient samples making us a leader in this space. And our test menu provides physicians with clinically actionable information they need to develop personalized treatment plans for their patients with cancer. Our proprietary biomarker assays are based on a unique platform that leverages information from both CTCs and ctDNA and we continue to generate clinical evidence supports the high sensitivity and specificity of our biomarker assays.

And lastly in addition to efforts to drive organic growth, we are focused on expanding opportunities through strategic partnerships and other initiatives by leveraging our investment in intellectual property.

And with that overview, we're now ready to take questions. Operator?

Question-and-Answer Session

Operator

[Operator Instructions] And we do have a question from Jason McCarthy from Maxim Group. Please go ahead with your question.

Jason McCarthy

Actually I have a couple of questions. Can you guys talk a little bit more about how the TC/PC is kind of the technical term with that Empower approach can be used by the pathology group or targeted doctor group to generate their own revenue and how that also translates into revenue for Biocept.

My second question is related to the Prognos collaboration and we really look at the stage from high above and when you look at groups like Roche that acquired Foundation for - I guess all in it was over $5 billion. And Guardant Health where that valuation has climbed to how does Biocept and Prognos plan to leverage the bioinformatics data that we assume is associated with Roche and Guardant Health and how that could translate into significant revenue potential for Biocept?

Michael Nall

Sure, no this is a great questions Jason. I am going to answer the Prognos question first and then we'll all in on the question on our Empower TC and how that works with local pathologists based in the community. So when it comes to Prognos like you mentioned we’re very excited about that because one of the things we've done really well here is built very high quality diagnostics laboratory with cutting-edge technologies. But with our funding we haven't had the resources necessary to invest in the type of bioinformatics support you would need to market the data that we're generating every day.

When we helped over 20,000 patients, we get all kinds of information from those patients specimens that has value to certain types of customers. The prime customers that Prognos is marketing to would be pharma and then down the road I think is - the insurance industry looking at demographic data. So the relationship with Prognos is done for Biocept is to allow us to have a foothold in that space once we launch.

So they provide the bioinformatic support. We have a rev share arrangement so it has no cost to us to make this investment which would have been as you know tens of millions if not hundreds of millions of dollars when you look at the money that has gone into Foundation and Guardant to provide that, so that's Prognos's role. Our role is continue to market and generate clinical results testing all of which populates this rich database that they apply their artificial intelligence or AI too, like to say their prime customer today is pharma company.

And I think they see in the future that managed care organizations will also be interested in this for demographic data. But the pharma companies have an immediate need both for development to assess the proper targets that are needed in the future, as well as them for actual marketing to know specifically where they should be putting their dollars for currently on market drugs and what regions those specimens come from.

Now the final reminder on that for everybody the information we provide to Prognos is all de-identified. So when we generate information from patients is protected and rightfully so by HIPAA. What their software does is just pull the actual results out not the patient information and then that's what is then used by them for commercialization. So did that answer your question?

Jason McCarthy

Yes, that’s very helpful. And then I guess we could segue over to the TC/PC question first?

Michael Nall

Yes, I’m going to kick it off and then I'm going to turn it over to Edwin to address kind of how they are focusing that with our new initiatives. But in essence the Empower TC has been modeled after a very successful programs in place by companies where we've all worked in the past. And on the tissue side on the anatomic pathology this is kind of the standard of care now for reference lab to their tissue information you place the results that the laboratory in the central lab such as a neo-genomics would generate.

They put that on a secure website that the local physician or pathologist logs into and they do their own reporting of the case. So they get the raw data from the laboratory and then they logon with their own secure password, get their patient information and then they generate their own report. The way that works is than the physician is able to get revenue for that actual work they're doing they are reporting. We get the revenue for the actual processing of the specimen.

This works about 85/15, 85% for processing their test that would stay with Biocept or neo-genomics or whoever is doing the TC part and the PC is about 15% and that's what the local pathologists would build. And it’s important to note this is a very compliant way that’s a standard-of-care in the industry. The cool thing of Biocept is we're the first and only ones today doing that in liquid biopsy.

So this is a huge advantage as liquid biopsy is now really taking off with the clinicians and becoming the standard-of-care. There is a want and a need for local physicians to participate in that.

With that I turn over and ask Edwin to add little bit color into that.

Edwin Hendrick

So again this is very exciting and in my past lives, the TC/PC or technical and professional component split was something that was developed with some of the companies that I worked with in the past. The key here is that just because the local pathologists in a community-based hospital may not have all of the equipment, but has had the training either to do flow cytometry or histology or immunohistochemistry, just because they're in a area that they can afford all the equipment does not necessarily mean those patients do not want to keep the patient comfort and care close to that physician and to be able to read it on site.

So we’re calling on two different types of groups. We're calling on the local pathology groups and the local hospitals to try to keep that business those patients local so they're not sending it out to a major reference laboratory. And then secondarily especially in the urology space, there's a lot of large urology group practices, called lab care center out there that are very, very large groups. They have their own laboratory if they are doing their own histology, their own immunohistochemistry and a great deal of many different tests. They employ their own pathologists in those groups so those are set cost that these groups have.

So the more tests that they can bring in-house, the busier that those pathologists can be and the better patient comfort and care you have because you're keeping that patient within the group and you're keeping all of the care done by the local urologist as well as that pathologist. So it's a nice handle.

So ultimately commercially in the future what we really like to do is to almost be a kind of use a restaurant analogy where if you want take out then we’ll do all the cooking for you. If you want some of our ingredients, we can do that and then you can cook some of it yourself and be able to read internally or ultimately you can buy the ingredients from us and when we do our kits as we’re moving forward as well. So we hope to from a commercial aspect cover all different areas of our brand in each one of these different types of sites.

Jason McCarthy

When I hear you saying is that if you are using the urology group these large practices and since they have their own pathologists in-house. They can even buy a kit from Biocept do their test venue, send the test back to you, they can access the information, they get a little bit of a revenue stream and it keeps more of their ability to diagnose, treat and monitor their patients in-house like essentially while either generating revenue or at least saving cost is that correct?

Michael Nall

Just about. The only part that’s a little nuance is that they don't have to have anything there from other than we provide specimen transport kits and no charge every reference lab does that. So that you send out the box that your specimen goes into at no charge and we cover the shipping that goes back to our lab, we provide the test and they just log on the Internet and get the information.

So when we talk and this is an important question Jason I think both get confused because in our industry we call that - they’re both called kits there's two different kits. One is the actual specimen transport kit that you use to simply get specimens back and forth throughout the world by FedEx. The other is a kit that actually has the chemistries and reagents in it so someone could do our testing in their own lab.

Today we’re only marketing that outside the U.S. for labs outside the U.S. to do their own testing. Someday in the future we’ll also do that in the U.S. but today that's an outside the U.S. strategy. In the U.S., our strategy is to drive business here to our own clear lab where we do the testing and then they have a choice of either do in their own interpretation of report or we can do the whole thing. Does that help?

Jason McCarthy

Yes, sounds very helpful. And then one last question can you talk - there is no obviously they didn’t present guidance in the press release. Can you talk a little bit about the testing volume and following the volume and how that's growing and maybe what you might expect given that the company is refocusing streamline with this new commercial sales effort. What is that volume look like going over 2019, now that the company is capitalized to really drive growth?

Michael Nall

Sure. As you know we don't give guidance and so at this point because it's still early days but two things that should give folks encouragement, as we have stated on the past calls we had a lot of growing pains that led to last year's reinvestment in the business both on our new commercial strategy that you heard about as well as in the things Tim mentioned in what I mentioned in mine about, we’re finding and automating our operations.

Those have both have been big investments for both paying off big time as we go into perfect timing because liquid biopsy is really hitting in stride. You see the valuation you mentioned of Guardant, and people are believing what this can be. We’re a substantial market share as well. And so we have every expectation and continue to see the kind of growth in the next quarters as you going forward that folks had seen from us in past years as well as going on into the future.

So Biocept got a great strategy going forward, we've made the necessary changes we need to in the business to get back on its growth trajectory, and as important the overall market itself is now ready for this growth as we take off. And the last piece with that we need to pay attention to is that the market for the big panels NGS which have a higher price point including when we launch our offering is there now and the reimbursement is there.

So it's a great time for Biocept to get into that business as well because we can launch our panel, do the necessary things and expect to get paid going forward once we get to the process with Medicare.

Operator

[Operator Instructions] And ladies and gentlemen at this time we'll end today's question-and-answer session. I like to turn the conference call back over to Mike Nall for any closing remarks.

Michael Nall

Thank you very much. I want to thank all of you for participating on today's call and for your interest in Biocept. We look forward to sharing our progress on our next conference call when we report our first quarter financial result. Thank you and everybody have a great day.

Operator

Ladies and gentlemen that does conclude today's conference call. We do thank you for attending today's presentation. You may now disconnect your lines.