Good afternoon, ladies and gentlemen, and thank you for standing by. Welcome to today's MDxHealth Half One 2018 Results Conference Call. [Operator Instructions] And now I would like to hand the conference over to your first speaker today, Jan Groen, Chief Executive Officer of MDxHealth. Please go ahead.

So, good afternoon everyone and welcome to our 2018 half year results call. I am Jan Groen, I am the Chief Executive Officer of MDxHealth and with me today is Jean-Marc Roelandt, our Chief Financial Officer. On Slide 2 please be reminded of our normal disclaimer. On Slide 3, I would I would like to begin by recapping all the potential of urology diagnostic market which we believe is worth in excess of 3 billion annual U.S. dollars. MDxHealth is the clear leader in molecular diagnostic for uro-oncology. It's currently the only company developing test right across the entire uro-oncology diagnostic spectrum, prostrate, bladder and kidney cancer. Now turning to the first half year highlights, that's on Slide 4. We’ve made good operational progress during the first half of 2018 and we are pleased with the healthy double-digit growth of our overall clinical testing volumes and particular with the strong growth of SelectMDx during the period. We continue to deliver on our four strategic objectives for growth. For ConfirmMDx, a primary driver of growth for the near-term we expect reimbursement for the product including expanded Medicare coverage. And overall cash collections were significantly up compared to the first half of 2017. For SelectMDx a core driver of growth over the longer term, the product was included in the European Association Urology Clinical Guidelines and we published a number impactful studies outlining the clinical utility and cost effectiveness of the test. As you know, we are looking to move this product into an active monitoring and primary care setting. We believe this will significantly impact our market share for SelectMDx across the U.S. and Europe. During the first half we also made good progress in the development of two new products which will see us double our product cancer product portfolio…

Thank you, Jan. I think you touched upon most of the financial highlights of the first half already. So I'll keep it brief and we'll start on Slide 22, where you can see that we are on-track to achieve our targets of hitting a higher level of products and services revenue growth than in 2017, which was 13%. Products and services revenue for the first half year 2018 was $16.6 million, up 39% from 12 million in the first half of 2017. Moving on to Slide 23, test volume continues to grow and we exhibited healthy year-on-year growth, up 30% on overall test volumes. As Jan mentioned earlier, ConfirmMDx continues to represent the bulk of our test volumes but SelectMDx exhibited very strong year-on-year growth of 67% during the period. On Slide 24, I can mention total revenue of $17.2 million, which compares to a normalized total revenue of $12.2 million during the first half of 2017. A onetime $12.1 million revenue from the sale of patents to Exact Sciences last year takes the H1 2017 total revenue number up to $24.3 million. Of the $17.2 million total revenue for H1 2018, 97% or $16.6 million consisted of products and services revenue. An 89% or $15.3 million came from the sales of ConfirmMDx and SelectMDx, 98% of which originated in the U.S, and was up 29% from H1 2017. Within that $15.3 million, ConfirmMDx revenue was $14.2 million, up 27% from the first-half 2017, and Select represented $1.1 million, up 46% from H1 2017. On top of that, we received $0.6 million of revenue from milestone in royalties including the MGMT license deal with LabCorp. As we only recognize revenue to the extent that we will collect, it is key for us to secure as many payors as possible. The…

Great, thank you, Jean-Marc. So to summarize, we have made good operational progress program during the first half 2018, and we are pleased with the healthy double digit growth of overall clinical testing volumes, revenues, and cash collections. Throughout the period, we continued to deliver on our status of strategic objectives for growth, for ConfirmMDx, the primary driver of growth in the near future. We expanded the reimbursement for the products including the coverage by Medicare, the recent LCD. For SelectMDX, a core driver of growth over the long-term, we've made good progress as we look to move this product into active monitoring of primary care setting. We believe this will significantly expand our market share for SelectMDx across the U.S. and Europe. In the second-half of this year, we anticipate submission for publications of the 4M prospective clinical study, which was completed in the first half 2018 by an independent entity. And as mentioned, we will continue to progress our two new products in prostate cancer in Inform and MonitorMDx. We remain positive about the outlook for the current year and maintain our view that year-over-year growth for product and service revenue will be higher than 2017, and we'll continue to update the market as the year progresses. And we now open for Q&A, and I'll give the floor back to the moderator.

[Operator Instructions] And our first question comes from the line of [Stephanie Putz] [ph]. Please ask your question.

Question on ConfirmMDx, can you give us the reordering rate that you see today for this test and maybe also the customer acquisition costs that you see today? And then for SelectMDx, can you guide us on how you see the evolution of the reimbursements in Europe and on which countries you are focusing today and maybe on the IVD to SelectMDx, how is this evolving? Thank you.

So we have not reported on the repetitive sales for ConfirmMDx in any of our press releases so far. So I cannot comment on that. I think the growth of 11% speaks for itself, I have to say. Regarding your question for SelectMDx for the European market is, we have five sales representative in the fields, focusing on Germany, France, Italy and the Benelux, as well as our partner in Spain, Ferrer Pharma, those will be the focus of the Company for the near-term future for the Select. And yes, we have developed an IVD kit for SelectMDx which runs on an open PCR platform that is available, but the key driver of success for the SelectMDx based on the European market is number one, to create awareness among the urology community, and that's what you have seen in the quite significant growth in the first half 2018 of close to 180%. Once the volume in the respective centers is high enough they could order the Select IVD kit to run in their laboratory. But as today for the commercial standpoint, we are selling, we are paid for each and every test that we are offering to the respective hospitals with the exception of course of the marketing implementation and clinical studies that we've performed in the first half of 2018.

Thank you. And your next question comes from the line of [Lenny Van Steenhuyzen] [ph]. Please ask your question.

First question I had is that while Confirm's volumes are quite low in the second quarter of the year, on the other hand cash collection on the test was quite impressive and I was wondering if you could please elaborate a bit on the reasons behind this dynamic. Second question I had is that the gap between total product revenues and the sum of Select and Confirm revenues is becoming wider and I was wondering if this might indicate that also AssureMDx is slowly contributing to revenue? Or perhaps if there would be another element in play? Thank you.

I'll start with the last one, Lenny. So, I assume you're referring to the difference between the 16.6 million products and services revenue and the 15.3 coming from Confirm and Select. The difference is clinical service testing, MGMT service testing which as you know has now moved to LabCorp following the license deal that we closed in the first quarter, so that 1.3 million difference is almost entirely attributable to MGMT service testing in the first quarter. Going forward that will be substituted by royalty income from that license agreement with LabCorp. On the cash collections, obviously it's very difficult to relate volumes from the first half 2018 with cash collections, as you know the collection periods are fairly lengthy specially for Confirm where we have a lengthy appeal process upon an initial denial. So the cash collections really relates to volumes sold in prior years. But what we obviously see is the result of our efforts to land more contracts with private payors, and although it's very difficult to discern a general trend on the impact of our CPT code and it is absolutely the case that upfront denial rates will come down which will lead to quicker and higher collections.

Thank you. Perhaps last question from my end, now in the past few weeks you had seen several cost effectiveness studies on the SelectMDx, do you expect in the coming periods perhaps further acceleration of Select growth with that in mind?

So, I think the health economic studies are key for future negotiations with European healthcare providers in terms of the reimbursement for the test, that's why we have completed four health economic studies in four EU member states; France, Spain, Germany and Italy and we already completed one for the Netherlands last year. So they are key in combination with additional validation study we have to complete in the respective countries, all four countries to have our medical dossier complete in order to start the discussions with the healthcare providers for reimbursement of that product in the respective countries. So they are key element for reimbursement. The package is not completed yet. But for sure it will contribute to the future growth of SelectMDx.

And your next question comes from the line of [Mike Vizik] [ph]. Please ask your question.

Just two from me. First on SelectMDx, you guys are submitting the Medicare package shortly. I'm just wondering what you expect in terms of increased uptake if Medicare decides to approve this for coverage? Would you see a certain amount of commercial insurers following that and would be quite a steep uplift in terms of uptake in the U.S. and my - sorry, go ahead.

Yes, go ahead, go ahead.

Sorry, my line is breaking up a bit.

I can answer your first question regarding Medicare, so yes we have signal to the market that we are completing medical dossier for SelectMDx and filing this for Medicare coverage. I have to refer them to the experience we have in the past with ConfirmMDx after we filed the package it took about six to nine months to receive coverage for the Confirm test a couple years ago. But as also indicated in one of the slides presented today, it had a significant impact also towards other payors to obtain coverage once we receive Medicare coverage. So and - the targeted patient population or subject because there is still no patient yet, we expect to be about 30% of our business will be Medicare patient that. And as we have seen today after received coverage for Confirm, Medicare pays for all their patients and on time so yes.

And just a second one from me, I remember towards the end of last year you had some samples from the VA Hospital that didn't come through in the fourth quarter and potentially spilled over into Q1. Did that play into the higher growth rate for the first quarter comparatively to the second for ConfirmMDx or is that effect equal across the two quarters?

There was indeed a spillover effect from one clinical study, it wasn't the VA, but it was a clinical study involving Medicare patients. And that spillover effect was limited to Q1. We mentioned in our quarterly update in Q1 that there were approximately 640 cases in Q1 all at the 2013 Medicare LIBOR rate. That did not reoccur in Q2 as expected so that affects the comparison from Q2 to Q1.

[Operator Instructions] And your next question comes from the line of Howard Halpern [Taglich Brothers, Inc.]. Please ask your question.

Thanks for taking my questions. First the sales force in the U.S. how was it structured and how is it evolving since you first implemented your sales force here?

So your question on the sales force, yes we have initiated to increase our sales force as of the - in the third quarter 2017. What we've done so far as we've divided currently in 42 territories and as of today we have covered most of these territories. We’re a little bit low in our coverage for certain territories. The healthy U.S. economy has put a lot of pressure on the sales organization so we see a lot of people jumping to another company but today we have around slightly below 40 reps in the field.

And what is your strategy to break into I guess the primary care area specifically in the U.S.?

Yes, so number one is of course we need the current test is only validated for elevated piece level north of 3 nanograms per mL all the way up to 10 nanograms per mL. So those guide in the Q4 a biopsy procedure. What we’re currently doing is number one completing several validation studies for SelectMDx in a lower PSA range and that would allow us to move the test forward into the primary care setting but it comes down to selling to a primary care physicians, you need to complete the difference sales mechanics or structure - in order to serve that market and we are currently weighing our options what will be the best way to serve that market.

And one final one question I have about the operating expenses. You see that staying pretty constant in the second half and also because you had mentioned in the press release about the amortization expenses were high. What could we expect that to be in the second half?

So we have been looking at a Q4 2017 run rate of over $12 million. So our expectation for the full year 2018 was $50 million to $52 million of operating expenses on the back of that run rate which was the first two quarter where we had the expanded sales force on board adding to that the increased amortization on internally developed intangibles which started this year. We will be looking at similar levels of expenses for the second half both in total, as well as on the amortization front. So the overall expectation of 50 million to 52 million still stands.

[Operator Instructions] There are no further questions at this time. Please continue.

Thank you all for participating in our conference call for the first half year results and we’ll keep you updated on the development within the company and the progress we are making for the second half of 2018. We will come out with our Q3 press release in the course of November 2018. Thank you so much for participation.

Thank you, all.

Thank you. That does conclude our conference for today. Thank you for participating. You may all disconnect. Speakers' please standby.